Drug administration system configured to determine a drug administration regimen

Abstract

In general, the present invention provides a system for administering a drug. In an exemplary embodiment, the drug administration system includes a drug administration device configured to communicate with a computer system, and at least one sensor configured to obtain sensor data and transmit the sensor data to the drug administration device. The drug administration device is configured to: utilize a first drug administration regimen when delivering the drug to a patient; determine a second drug administration regimen for delivering the drug to the patient based on the administration data from the computer system and the sensor data collected by the sensor during and / or after delivering the first drug according to the first drug administration regimen; and utilize the second drug administration regimen when delivering the drug to the patient.

Description

Technical Field

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

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

[0003] Drugs are usually administered to patients according to a drug administration regimen. A drug administration regimen may specify the volume of the drug to be administered, the frequency of drug administration, the time of drug administration, etc. Typically, a doctor or other healthcare professional will formulate a starting drug administration regimen for a patient based on administration data such as the patient's weight, height, and age. However, this starting drug administration regimen may not be optimal, and furthermore, factors that not only affect the patient's response to the drug administration regimen but also change over time will not be considered. Therefore, patients may have to monitor their response to the drug administration regimen and the factors that may affect their response, so as to work extensively with a doctor to optimize the drug administration regimen, and therefore ensure that the drug administration regimen is effective.

[0004] Optimization of drug dosing regimens depends largely on patient compliance with the initial drug dosing regimen and accurate, regular monitoring of patient symptoms. In addition, in some cases, patients may be required to monitor a large number of factors and take all of these factors into account to calculate drug dosing regimen adjustments. If patients fail to properly consider all necessary factors or do not properly monitor their symptoms, the drug dosing regimen may not be adjusted accordingly, and therefore the drug dosing regimen may be ineffective.

[0005] Regarding how to administer the drug to the patient, there are various dosage forms that can be used. For example, these dosage forms can include one or more parenteral, inhalation, oral, ophthalmic, nasal and suppository forms of the drug.

[0006] These dosage forms can be administered directly to the patient via a drug administration device.There are a number of different types of drug administration devices that are commonly used to deliver various dosage forms, including: syringes, injection devices (eg, autoinjectors, jet injectors, and infusion pumps), nasal spray devices, and inhalers. Summary of the invention

[0007] In one aspect, a drug administration system is provided, which in one embodiment includes a drug administration device, which includes a communication interface configured to communicate with a communication interface of a computer system. The drug administration device also includes at least one sensor, which is configured to obtain sensor data and transmit the sensor data to the drug administration device. The drug administration device is configured to utilize a first drug administration regimen when the drug is delivered from the drug administration device to the patient, and determine a second drug administration regimen for delivering the drug from the drug administration device to the patient. The second drug administration regimen depends on the administration data from the computer system and the sensor data from the at least one sensor. The sensor data is obtained by the at least one sensor during and / or after the drug is delivered according to the first drug administration regimen. The drug administration device is also configured to utilize a second drug administration regimen when the drug is delivered from the drug administration device to the patient.

[0008] The drug administration device can be varied in any manner. For example, the drug administration device can be configured to determine a first drug administration regimen for delivering the drug to the patient before utilizing the first drug administration regimen when the drug is delivered from the drug administration device to the patient. For another example, each of the first drug administration regimen and the second drug administration regimen can each specify one or more of the following drug administration parameters: drug delivery rate, drug delivery time and / or date, drug delivery volume, and drug delivery duration. For another example, the at least one sensor may include one or more of the following: a patient monitoring sensor configured to obtain sensor data related to the patient's condition; a device sensor configured to obtain sensor data related to the drug administration device; an environmental sensor configured to obtain sensor data related to the environment in which the drug administration device exists; and a position sensor configured to obtain sensor data related to the geographic location of the drug administration device. For another example, the drug administration system may also include at least one external sensor, the at least one external sensor configured to obtain external sensor data and transmit the external sensor data to the computer system, and the second drug administration regimen may further depend on the external sensor data from the computer system. For another example, the drug administration system may further include a second drug administration device, the second drug administration device including a communication interface configured to communicate with the communication interface of the computer system, and the drug administration may further include at least one sensor, the at least one sensor configured to obtain supplemental sensor data and transmit the supplemental sensor data to the second drug administration device, and the second drug administration regimen may be further determined depending on the supplemental sensor data from the computer system.

[0009] For another example, the drug administration system may further include a second drug administration device, the second drug administration device including a communication interface configured to communicate with the communication interface of the computer system, and the drug administration may further include at least one user interface, the at least one user interface configured to obtain supplementary user input data and transmit the supplementary user input data to the second drug administration device, and the second drug administration regimen may be further determined based on the supplementary user input data from the computer system. In at least some embodiments, the system may also include at least one sensor, the at least one sensor configured to obtain supplementary sensor data and transmit the supplementary sensor data to the second drug administration device, and the second drug administration regimen may be further determined based on the supplementary sensor data from the computer system. The at least one sensor may be configured to obtain supplementary sensor data, the at least one sensor including one or more of the following: a patient monitoring sensor configured to obtain supplementary sensor data related to the patient's condition; a device sensor configured to obtain supplementary sensor data related to the second drug administration device; an environmental sensor configured to obtain supplementary sensor data related to the environment in which the second drug administration device is present; and a location sensor configured to obtain supplementary sensor data related to the geographic location of the second drug administration device.

[0010] For another example, the drug administration device may be an automatic injector, and the first drug administration regimen and the second drug administration regimen may each specify one or more of the following administration parameters: a discharge nozzle advancement depth of the discharge nozzle during drug delivery to the patient, a discharge nozzle velocity of the discharge nozzle during drug delivery to the patient, and a discharge nozzle acceleration of the discharge nozzle during drug delivery to the patient. For another example, the drug administration device may be an inhaler. For another example, the drug administration device may be an infusion pump.

[0011] In another example, the first drug dosing regimen may be determined depending on the dosing data transmitted from the computer system. In another example, the first drug dosing regimen and the second drug dosing regimen may each specify one or more of a drug delivery rate, a drug delivery volume, and a drug delivery duration, and the value of one or more of the parameters in the first drug dosing regimen is different from the value of the corresponding parameter in the second drug dosing regimen.

[0012] For another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

[0013] In another embodiment, a drug administration system includes a drug administration device including a communication interface configured to communicate with a communication interface of a computer system. The system also includes at least one user interface configured to obtain user input data and transmit the user input data to the drug administration device. The drug administration device is configured to utilize a first drug administration regimen when the drug is delivered from the drug administration device to the patient, and to determine a second drug administration regimen for delivering the drug to the patient. The second drug administration regimen depends on the administration data from the computer system and the user input data from the at least one user interface. The user input data is obtained by the user interface during and / or after the drug is delivered from the drug administration device according to the first drug administration regimen. The drug administration device is also configured to utilize a second drug administration regimen when the drug is delivered from the drug administration device to the patient.

[0014] The drug administration system may have any number of variations. For example, the drug administration device may be configured to determine a first drug administration regimen for delivering the drug from the drug administration device to the patient before utilizing the first drug administration regimen when the drug is delivered from the drug administration device to the patient. For another example, the system may include at least one sensor, the at least one sensor being configured to obtain sensor data and transmit the sensor data to the drug administration device, the drug administration device being configured to further determine a second drug administration regimen depending on the sensor data from the at least one sensor, and the sensor data being obtained by the at least one sensor during and / or after the drug is delivered from the drug administration device according to the first drug administration regimen. For another example, each of the first drug administration regimen and the second drug administration regimen may each specify one or more of the following drug administration parameters: drug delivery rate, drug delivery time and / or date, drug delivery volume, and drug delivery duration.

[0015] As another example, the at least one sensor may include one or more of the following: a patient monitoring sensor configured to obtain sensor data related to the patient's condition; a device sensor configured to obtain sensor data related to the drug administration device; an environmental sensor configured to obtain sensor data related to the environment in which the drug administration device is located; and a location sensor configured to obtain sensor data related to the geographic location of the drug administration device.

[0016] As another example, the drug administration system may further include at least one external sensor configured to obtain external sensor data and transmit the external sensor data to the computer system, and the second drug administration regimen may further depend on the external sensor data from the computer system.

[0017] For another example, the drug administration system may further include a second drug administration device, the second drug administration device including a communication interface configured to communicate with the communication interface of the computer system, and the drug administration may further include at least one sensor, the at least one sensor configured to obtain supplemental sensor data and transmit the supplemental sensor data to the second drug administration device, and the second drug administration regimen may be further determined depending on the supplemental sensor data from the computer system.

[0018] For another example, the drug administration system may further include a second drug administration device, the second drug administration device including a communication interface configured to communicate with the communication interface of the computer system, and the drug administration may further include at least one user interface, the at least one user interface configured to obtain supplementary user input data and transmit the supplementary user input data to the second drug administration device, and the second drug administration regimen may be further determined based on the supplementary user input data from the computer system. In at least some embodiments, the system may also include at least one sensor, the at least one sensor configured to obtain supplementary sensor data and transmit the supplementary sensor data to the second drug administration device, and the second drug administration regimen may be further determined based on the supplementary sensor data from the computer system. The at least one sensor may be configured to obtain supplementary sensor data, the at least one sensor including one or more of the following: a patient monitoring sensor configured to obtain supplementary sensor data related to the patient's condition; a device sensor configured to obtain supplementary sensor data related to the second drug administration device; an environmental sensor configured to obtain supplementary sensor data related to the environment in which the second drug administration device is present; and a location sensor configured to obtain supplementary sensor data related to the geographic location of the second drug administration device.

[0019] For another example, the drug administration device may be an automatic injector, and the first drug administration regimen and the second drug administration regimen may each specify one or more of the following administration parameters: a discharge nozzle advancement depth of the discharge nozzle during drug delivery to the patient, a discharge nozzle velocity of the discharge nozzle during drug delivery to the patient, and a discharge nozzle acceleration of the discharge nozzle during drug delivery to the patient. For another example, the drug administration device may be an inhaler. For another example, the drug administration device may be an infusion pump.

[0020] In another example, the first drug dosing regimen may be determined depending on the dosing data transmitted from the computer system. In another example, the first drug dosing regimen and the second drug dosing regimen may each specify one or more of a drug delivery rate, a drug delivery volume, and a drug delivery duration, and the value of one or more of the parameters in the first drug dosing regimen is different from the value of the corresponding parameter in the second drug dosing regimen.

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

[0022] In another aspect, a method of determining a drug dosing regimen for delivering a drug to a patient is provided, and the method in one embodiment includes: using a drug administration device to deliver the drug to the patient according to a first drug dosing regimen; using a sensor to obtain sensor data; determining, on the drug administration device, a second drug dosing regimen for delivering the drug from the drug administration device to the patient depending on the sensor data and dosing data from a computer system; and using the drug administration device to deliver the drug to the patient according to the second drug dosing regimen.

[0023] The method may have any number of variations. For example, the method may further include determining, on the drug administration device, a first drug dosing regimen for delivering the drug to the patient prior to delivering the drug to the patient according to the first drug dosing regimen.

[0024] For another example, each of the first drug administration regimen and the second drug administration regimen may specify at least one of a drug delivery rate, a drug delivery volume, and a drug delivery duration. For another example, using a sensor to obtain sensor data includes at least one of the following: using a patient monitoring sensor to obtain sensor data related to the patient's condition; using a device sensor to obtain sensor data related to a drug administration device; using an environmental sensor to obtain sensor data related to the environment in which the drug administration device exists; and using a location sensor to obtain sensor data related to the geographic location of the drug administration device. For another example, the method may include using an external sensor to obtain external sensor data, and determining a second drug administration regimen for delivering the drug to the patient may include further depending on the external sensor data to determine the second drug administration regimen. For another example, the method may include using a supplemental sensor to obtain supplemental sensor data, the method may include transmitting the supplemental sensor data to a second drug administration device, and determining a second drug administration regimen for delivering the drug to the patient may include further depending on the supplemental sensor data to determine the second drug administration regimen for delivering the drug to the patient. Using supplemental sensors to obtain supplemental sensor data may include at least one of: using patient monitoring sensors to obtain supplemental sensor data related to the patient's condition; using device sensors to obtain supplemental sensor data related to the drug administration device; using environmental sensors to obtain supplemental sensor data related to the environment in which the drug administration device is present; and using location sensors to obtain supplemental sensor data related to the geographic location of the drug administration device.

[0025] As another example, the method may include using a user interface to obtain supplemental user input data, the method may include transmitting the supplemental user input data to a second drug administration device, and determining a second drug administration regimen for delivering the drug to the patient may include further depending on the supplemental user input data to determine the second drug administration regimen for delivering the drug to the patient. In at least some embodiments, the method may include using a supplemental sensor to obtain supplemental sensor data, the method may include transmitting the supplemental sensor data to a second drug administration device, and determining a second drug administration regimen for delivering the drug to the patient may include further depending on the supplemental sensor data to determine the second drug administration regimen for delivering the drug to the patient. Using the supplemental sensor to obtain the supplemental sensor data may include at least one of: using a patient monitoring sensor to obtain supplemental sensor data related to the patient's condition; using a device sensor to obtain supplemental sensor data related to the drug administration device; using an environmental sensor to obtain supplemental sensor data related to the environment in which the drug administration device is located; and using a location sensor to obtain supplemental sensor data related to the geographic location of the drug administration device.

[0026] For another example, the drug administration device may be an automatic injector, and determining the first drug administration regimen and the second drug administration regimen includes specifying one or more of the following parameters: a discharge nozzle advancement depth of a discharge nozzle for delivering the drug to the patient, a discharge nozzle velocity of a discharge nozzle for delivering the drug to the patient, and a discharge nozzle acceleration of a discharge nozzle for delivering the drug to the patient. For another example, the drug delivery device may be an inhaler. For another example, the drug delivery device may be an infusion pump.

[0027] In another example, the method may include transmitting drug administration data from the computer system to the drug administration device, and determining, on the drug administration device, a first drug administration regimen for delivering the drug to the patient based on the drug administration data. In another example, the first drug administration regimen and the second drug administration regimen may specify one or more of the following drug administration parameters: drug delivery rate, drug delivery volume, and drug delivery duration, and the value of one or more of the parameters in the first drug administration regimen is different from the value of the corresponding parameter in the second drug administration regimen.

[0028] For another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

[0029] In another embodiment, a method of determining a drug dosing regimen for delivering a drug to a patient includes using a drug administration device to deliver the drug to the patient according to a first drug dosing regimen; using a user interface to obtain user input data; determining, at the drug administration device, a second drug dosing regimen for delivering the drug from the drug administration device to the patient depending on the user input data and dosing data from a computer system; and using the drug administration device to deliver the drug to the patient according to the second drug dosing regimen.

[0030] The method can be varied in any number of ways. For example, the method may include determining a first drug dosing regimen for delivering the drug to the patient on a drug administration device before delivering the drug to the patient according to the first drug dosing regimen. For another example, the method may include using a sensor to obtain sensor data, and further determining a second drug dosing regimen for delivering the drug to the patient based on the sensor data.

[0031] For another example, each of the first drug administration regimen and the second drug administration regimen may specify at least one of a drug delivery rate, a drug delivery volume, and a drug delivery duration. For another example, using a sensor to obtain sensor data includes at least one of the following: using a patient monitoring sensor to obtain sensor data related to the patient's condition; using a device sensor to obtain sensor data related to a drug administration device; using an environmental sensor to obtain sensor data related to the environment in which the drug administration device exists; and using a location sensor to obtain sensor data related to the geographic location of the drug administration device. For another example, the method may include using an external sensor to obtain external sensor data, and determining a second drug administration regimen for delivering the drug to the patient may include further depending on the external sensor data to determine the second drug administration regimen. For another example, the method may include using a supplemental sensor to obtain supplemental sensor data, the method may include transmitting the supplemental sensor data to a second drug administration device, and determining a second drug administration regimen for delivering the drug to the patient may include further depending on the supplemental sensor data to determine the second drug administration regimen for delivering the drug to the patient. Using supplemental sensors to obtain supplemental sensor data may include at least one of: using patient monitoring sensors to obtain supplemental sensor data related to the patient's condition; using device sensors to obtain supplemental sensor data related to the drug administration device; using environmental sensors to obtain supplemental sensor data related to the environment in which the drug administration device is present; and using location sensors to obtain supplemental sensor data related to the geographic location of the drug administration device.

[0032] As another example, the method may include using a user interface to obtain supplemental user input data, the method may include transmitting the supplemental user input data to a second drug administration device, and determining a second drug administration regimen for delivering the drug to the patient may include further depending on the supplemental user input data to determine the second drug administration regimen for delivering the drug to the patient. In at least some embodiments, the method may include using a supplemental sensor to obtain supplemental sensor data, the method may include transmitting the supplemental sensor data to a second drug administration device, and determining a second drug administration regimen for delivering the drug to the patient may include further depending on the supplemental sensor data to determine the second drug administration regimen for delivering the drug to the patient. Using the supplemental sensor to obtain the supplemental sensor data may include at least one of: using a patient monitoring sensor to obtain supplemental sensor data related to the patient's condition; using a device sensor to obtain supplemental sensor data related to the drug administration device; using an environmental sensor to obtain supplemental sensor data related to the environment in which the drug administration device is located; and using a location sensor to obtain supplemental sensor data related to the geographic location of the drug administration device.

[0033] For another example, the drug administration device may be an automatic injector, and determining the first drug administration regimen and the second drug administration regimen includes specifying one or more of the following parameters: a discharge nozzle advancement depth of a discharge nozzle for delivering the drug to the patient, a discharge nozzle velocity of a discharge nozzle for delivering the drug to the patient, and a discharge nozzle acceleration of a discharge nozzle for delivering the drug to the patient. For another example, the drug delivery device may be an inhaler. For another example, the drug delivery device may be an infusion pump.

[0034] In another example, the method may include transmitting drug administration data from the computer system to the drug administration device, and determining, on the drug administration device, a first drug administration regimen for delivering the drug to the patient based on the drug administration data. In another example, the first drug administration regimen and the second drug administration regimen may specify one or more of the following drug administration parameters: drug delivery rate, drug delivery volume, and drug delivery duration, and the value of one or more of the parameters in the first drug administration regimen is different from the value of the corresponding parameter in the second drug administration regimen.

[0035] For another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The present invention is described with reference to the following drawings:

[0037] Figure 1 is a schematic diagram of a first type of drug administration device, namely an auto-injector;

[0038] Figure 2 is a schematic diagram of a second type of drug administration device, namely an infusion pump;

[0039] Figure 3 is a schematic diagram of a third type of drug administration device, namely an inhaler;

[0040] Figure 4 is a schematic diagram of a fourth type of drug administration device, namely a nasal spray device;

[0041] Figure 5A is a schematic diagram of a general drug administration device;

[0042] Figure 5B is a schematic diagram of a universal drug administration device;

[0043] Figure 6 is a schematic diagram of a housing for a dosage form;

[0044] Figure 7is a schematic diagram of one embodiment of a drug administration device and a communication network system with which a housing may operate;

[0045] Figure 8 is a schematic diagram of one embodiment of a drug administration device and a computer system with which the housing may operate;

[0046] Fig. 9 is a schematic diagram of one embodiment of a drug administration system;

[0047] Fig. 10A is a schematic diagram of another embodiment of a drug administration system;

[0048] Fig. 10B It is shown by Fig. 10A A schematic diagram of data obtained by a sensor of an embodiment of the present invention;

[0049] Fig.11A is a schematic diagram of another embodiment of a drug administration system;

[0050] Fig. 11B It is shown by Fig.11A A schematic diagram of data obtained by a sensor of an embodiment of the present invention;

[0051] Fig. 12A is a schematic diagram of another embodiment of a drug administration system;

[0052] Fig. 12B It is shown by Fig. 12A A schematic diagram of data obtained by a sensor of an embodiment of the present invention;

[0053] Fig.13A is a schematic diagram of another embodiment of a drug administration system;

[0054] Fig. 13B It is shown by Fig.13A A schematic diagram of data obtained by a sensor of an embodiment of the present invention;

[0055] Fig.14 is a schematic diagram of another embodiment of a drug administration system;

[0056] Fig.15 is a schematic diagram of another embodiment of a drug administration system;

[0057] Fig.16A is a schematic diagram of one embodiment of a drug administration device including a temperature sensor; and

[0058] Fig. 16B yes Fig.16A End view of a drug administration device. DETAILED DESCRIPTION

[0059] Certain exemplary embodiments will now be described to understand the principles of the structure, function, manufacture and use of the devices, systems and methods disclosed herein as a whole. One or more examples of these embodiments are shown in the accompanying drawings. It will be appreciated by those skilled in the art that the devices, systems and methods specifically described herein and shown in the accompanying drawings are non-restrictive exemplary embodiments, and the scope of the present invention is limited only by the claims. The features shown or described in conjunction with an exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

[0060] In addition, in the present disclosure, components with similar names in various embodiments generally have similar features, so in a specific embodiment, each feature of each component with similar names may not necessarily be fully described. In addition, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that equivalent dimensions of such linear and circular dimensions can be easily determined for any geometric shape. Those skilled in the art will understand that the dimensions may not be exact values, but are considered to be approximately at the value due to any number of factors such as manufacturing tolerances and the sensitivity of the measuring equipment. The size and shape of the systems and devices and their components may depend at least on the size and shape of the components with which the systems and devices will be used.

[0061] Examples of various types of drug administration devices, namely, an auto-injector 100 , an infusion pump 200 , an inhaler 300 , and a nasal spray device 400 , are described below with reference to the above-mentioned drawings.

[0062] Auto-injectors

[0063] Figure 11 is a schematic, exemplary view of a first type of drug delivery device, i.e., an injection device, in this example, an auto-injector 100, that can be used with the embodiments described herein. The auto-injector 100 includes a drug holder 110 that retains the drug to be dispensed and a dispensing mechanism 120 that is configured to dispense the drug from the drug holder 110 so that the drug can be administered to a patient. The drug holder 110 is typically in the form of a container containing the drug, for example, it can be provided in the form of a syringe or a vial, or any other suitable container that can hold the drug. The auto-injector 100 includes a discharge nozzle 122, such as a needle of a syringe, which is disposed at the distal end of the drug holder 110. The dispensing mechanism 120 includes: a drive element 124, which itself may also include a piston and / or a piston rod; and a drive mechanism 126. The dispensing mechanism 120 is located proximal to the end of the drug holder 110 and is positioned toward the proximal end of the auto-injector 100.

[0064] The auto-injector 100 includes a housing 130 that contains a drug holder 110, a drive element 124, and a drive mechanism 126 within the body of the housing 130, and includes a discharge nozzle 122 that will typically be completely contained within the housing prior to injection, but will extend from the housing 130 during the injection sequence to deliver the drug. The dispensing mechanism 120 is arranged so that the advancing drive element 124 passes through the drug holder 110 so as to dispense the drug through the discharge nozzle 122, thereby allowing the auto-injector to administer the drug retained in the drug holder 110 to the patient. In some cases, the user can manually advance the drive element 124 through the drug holder 110. In other cases, the drive mechanism 126 may include a stored energy source 127 that advances the drive element 124 without user assistance. The stored energy source 127 may include a resilient biasing member such as a spring or pressurized gas, or an electric motor and / or a gear box.

[0065] The autoinjector 100 includes a dispensing mechanism protection mechanism 140. The dispensing mechanism protection mechanism 140 generally has two functions. First, the dispensing mechanism protection mechanism 140 can function to prevent access to the discharge nozzle 122 before and after an injection. Second, the autoinjector 100 can function so that the dispensing mechanism 120 can be activated when placed in an activated state, for example, when the dispensing mechanism protection mechanism 140 is moved to an unlocked position.

[0066] When the drug holder 110 is in its retracted position located proximally within the housing 130, the protection mechanism 140 covers at least a portion of the discharge nozzle 122. This is to hinder contact between the discharge nozzle 122 and the user. Alternatively or in addition, the protection mechanism 140 itself is configured to retract proximally to expose the discharge nozzle 122 so that the discharge nozzle can be brought into contact with the patient. The protection mechanism 140 includes a shield member 141 and a return spring 142. When no force is applied to the distal end of the protection mechanism 140, the return spring 142 acts to extend the shield member 141 from the housing 130, thereby covering the discharge nozzle 122. If the user applies a force to the shield member 141 against the action of the return spring 142 to overcome the bias of the return spring 142, the shield member 141 retracts into the housing 130, thereby exposing the discharge nozzle 122. Alternatively or in addition, the protection mechanism 140 may include an extension mechanism (not shown) for extending the discharge nozzle 122 beyond the housing 130 and may also include a retraction mechanism (not shown) for retracting the discharge nozzle 122 into the housing 130. Alternatively or in addition, the protection mechanism 140 may include a housing cover and / or a discharge nozzle cover that may be attached to the autoinjector 100. Removing the housing cover will typically also remove the discharge nozzle cover from the discharge nozzle 122.

[0067] The auto-injector 100 also includes a trigger 150. The trigger 150 includes a trigger button 151 located on an outer surface of the housing 130 such that the trigger button is accessible to a user of the auto-injector 100. When the user depresses the trigger 150, the trigger acts to release the drive mechanism 126, causing the drug to be expelled from the drug holder 110 via the drive element 124 and subsequently via the discharge nozzle 122.

[0068] The trigger 150 may also cooperate with the shield member 141 in such a way that the trigger 150 is prevented from being activated until the shield member 141 has been fully retracted proximally into the housing 130 to enter the unlocked position, for example by pushing the distal end of the shield member 141 against the patient's skin. When this has been done, the trigger 150 is unlocked and the auto-injector 100 is activated so that the trigger 150 can be depressed and an injection and / or drug delivery sequence is then initiated. Alternatively, retracting the shield member 141 alone into the housing 130 in the proximal direction can be used to activate the drive mechanism 126 and initiate an injection and / or drug delivery sequence. In this way, the auto-injector 100 has a device operation prevention mechanism that prevents the mechanism from preventing the dispensing of the drug by, for example, preventing an accidental release of the dispensing mechanism 120 and / or an accidental actuation of the trigger 150.

[0069] Although the foregoing description relates to one example of an autoinjector, this example is presented for illustration only and the present invention is not limited to such an autoinjector. Those skilled in the art will appreciate that various modifications to the described autoinjector may be implemented within the scope of the present disclosure.

[0070] The autoinjectors of the present disclosure may be used to administer any of a variety of drugs, such as any of epinephrine, rebif, etanercept, enrofloxacin, atropine, pralidoxime chloride, and diazepam.

[0071] Infusion Pump

[0072] In other cases, patients may require precise continuous drug delivery or drug delivery that occurs periodically or frequently at set periodic intervals. Infusion pumps can provide such controlled drug infusions by facilitating administration of the drug at a precise rate that keeps drug concentrations within the therapeutic range without requiring frequent attention from a healthcare professional or patient.

[0073] Figure 2 2 is a schematic illustrative view of a second type of drug delivery device, i.e., an infusion pump 200, which can be used with the embodiments described herein. The infusion pump 200 includes a drug holder 210 in the form of a reservoir for accommodating the drug to be delivered, and a dispensing mechanism 220 including a pump 216, which is suitable for dispensing the drug contained in the reservoir so that the drug can be delivered to the patient. These components of the infusion pump are located in the housing 230. The dispensing mechanism 220 also includes an infusion line 212. The drug is delivered from the reservoir via the infusion line 212 when the pump 216 is actuated, and the infusion line can be in the form of a cannula. The pump 216 can be in the form of a motor-controlled piston in an elastic pump, a peristaltic pump, an osmotic pump, or a syringe. Typically, the drug is delivered intravenously, but subcutaneous infusion, arterial infusion, and epidermal infusion can also be used.

[0074] The infusion pumps of the present disclosure may be used to administer any of a variety of drugs, such as any of insulin, atropine sulfate, avibactam sodium, bendamustine hydrochloride, carboplatin, daptomycin, epinephrine, glucagon, levetiracetam, oxaliplatin, paclitaxel, pantoprazole sodium, treprostinil, vasopressin, voriconazole, and zoledronic acid.

[0075] The infusion pump 200 includes control circuitry, such as a processor 296, in addition to a memory 297 and a user interface 280, which together provide a trigger mechanism and / or a dose selector for the pump 200. The user interface 280 may be implemented by a display screen located on the housing 230 of the infusion pump 200. The control circuitry and user interface 280 may be located within the housing 230, or external to the housing, and communicate with the pump 216 via a wired or wireless interface to control the operation of the pump.

[0076] The actuation of pump 216 is controlled by processor 296, which communicates with pump 216 to control the operation of the pump. Processor 296 can be programmed by a user (e.g., a patient or a healthcare professional) via user interface 280. This enables infusion pump 200 to deliver drugs to a patient in a controlled manner. The user can input parameters such as infusion duration and delivery rate. The delivery rate can be set to a constant infusion rate by the user, or can be set to a set interval for periodic delivery, which is usually within pre-programmed limits. The programming parameters for controlling pump 216 are stored in a memory 297 that communicates with processor 296 and retrieved from the memory. User interface 280 can take the form of a touch screen or keyboard.

[0077] Power source 295 provides power to pump 216 and may take the form of an energy source integral to pump 216 and / or a mechanism for connecting pump 216 to an external power source.

[0078] The infusion pump 200 can take a variety of different physical forms depending on its intended use. It can be a fixed, non-portable device, such as for use at a patient's bedside, or it can be an ambulatory infusion pump designed to be portable or wearable. The integrated power source 295 is particularly beneficial for ambulatory infusion pumps.

[0079] Although the foregoing description relates to an example of an infusion pump, this example is provided for illustration only. The present disclosure is not limited to such an infusion pump. Those skilled in the art will appreciate that various modifications to the described infusion pump may be implemented within the scope of the present disclosure. For example, the processor may be preprogrammed so that the infusion pump does not have to include a user interface.

[0080] Inhaler

[0081] Figure 33 is a schematic diagram of a drug application device of the third type, i.e., an inhaler 300. The inhaler 300 includes a drug holder 310 in the form of a can. The drug holder 310 contains a drug that will generally be in the form of a solution or suspension with a suitable carrier fluid. The inhaler 300 also includes a dispensing mechanism 320, which includes a pressurized gas for pressurizing the drug holder 310, a valve 325, and a nozzle 321. The valve 325 forms the outlet of the drug holder 310. The valve 325 includes a narrow opening 324 formed in the drug holder 310 and a movable element 326 controlling the opening 324. When the movable element 326 is in a stationary position, the valve 325 is in a closed or unactuated state, in which the opening 324 is closed and the drug holder 310 is sealed. When the movable element 326 is actuated from the stationary position to the actuated position, the valve 325 is actuated to an open state, in which the opening 324 is open. The actuation of movable element 326 from rest position to actuation position comprises that movable element 326 is moved in the medicine holder 310.Movable element 326 is elastically biased in the rest position.In the open state of valve 325, pressurized gas will be in the medicine of solution or suspension form with suitable liquid and pushes out medicine holder 310 through opening 324 at a high speed.Liquid causes liquid atomization through narrow opening 324 at a high speed, that is to say, changes the mist of liquid fine droplets and / or changes into gas cloud from bulk liquid.The patient can suck the mist of fine droplets and / or gas cloud in the respiratory tract.Therefore, inhaler 300 can be delivered to the patient's respiratory tract by the medicine that is retained in the medicine holder 310.

[0082] The medicine holder 310 is removably held in the housing 330 of the inhaler 300. The passage 333 formed in the housing 330 connects the first opening 331 in the housing 330 and the second opening 332 in the housing 330. The medicine holder 310 is received in the passage 333. The medicine holder 310 can be slidably inserted into the passage 333 through the first opening 331 of the housing 330. The second opening 332 of the housing 330 forms an oral piece 322 configured to be placed in the oral cavity of the patient, or a nasal piece configured to be placed in the nostril of the patient, or a mask configured to be placed on the mouth and nose of the patient. The medicine holder 310, the first opening 331 and the passage 333 are sized so that air can flow through the passage 333, flow around the medicine holder 310, and flow between the first opening 331 and the second opening 332. The inhaler 300 can be provided with a dispensing mechanism protection mechanism 140 in the form of a cap (not shown), which can be assembled to the oral piece 322.

[0083] Inhaler 300 also includes trigger 350, and this trigger includes valve actuation feature 355, and this valve actuation feature is configured to actuate valve 325 when trigger 350 is activated.Valve actuation feature 355 is the protrusion of housing 330 into passage 333.Medicine holder 310 can be slidably moved to second position from first position in passage 333.In first position, the end of movable element 326 in static position abuts valve actuation feature 355.In second position, medicine holder 310 can be shifted toward valve actuation feature 355, so that valve actuation feature 355 moves movable element 326 into medicine holder 310 to actuate valve 325 to open state.The hand of user provides required force to move medicine holder 310 from first position to second position with movable element 326 against elastic bias.Valve actuation feature 355 includes inlet 356 connected to nozzle 321. Inlet 356 of valve actuation feature 355 is sized and positioned to couple to opening 324 of valve 325 so that a sprayed mist of droplets and / or a gas cloud can enter inlet 356 and exit nozzle 321 to enter passage 333. Nozzle 321 facilitates atomizing bulk liquid into a mist of droplets and / or a gas cloud.

[0084] The valve 325 provides a metering mechanism 370. The metering mechanism 370 is configured to close the valve after a measured amount of liquid, and therefore medicament, has passed through the opening 324. This allows a controlled dose to be administered to the patient. Typically, the measured amount of liquid is preset, however, the inhaler 300 may be equipped with a dose selector 360 that can be operated by the user to change the defined amount of liquid.

[0085] Although the foregoing description relates to a specific example of an inhaler, this example is illustrative only. The description should not be considered as being limited to this inhaler. It is understood by those skilled in the art that numerous other types of inhalers and sprayers can be used together with the present disclosure. For example, the medicine can be in powdered form, the medicine can be in liquid form, or the medicine can be atomized by a dispensing mechanism 320 of other forms including ultrasonic vibration, compressed gas, vibrating net or heat source.

[0086] The inhaler of the present disclosure can be used to administer any of a variety of drugs, such as any of mometasone, fluticasone, ciclesonide, budesonide, beclomethasone, vilanterol, salmeterol, formoterol, umeclidinium, glycopyrrolate, tiotropium, aclidinium, indacaterol, salmeterol, and olodaterol.

[0087] Nasal spray device

[0088] Figure 44 is a schematic diagram of a fourth type of drug administration device, namely a nasal spray device 400. The nasal spray device 400 is configured to discharge the drug into the patient's nose. The nasal spray device 400 includes a drug holder 402, which is configured to contain the drug therein for delivery from the device 400 to the patient. The drug holder 102 may have a variety of configurations, such as a bottle-shaped reservoir, a box, a vial (as in the embodiment shown), a blow-fill-seal (BFS) capsule, a blister package, etc. In an exemplary embodiment, the drug holder 402 is a vial. The exemplary vial is formed by one or more materials such as glass, polymers, etc. In some embodiments, the vial may be formed by glass. In other embodiments, the vial may be formed by one or more polymers. In yet other embodiments, different parts of the vial may be formed by different materials. The exemplary vial may include a variety of features to facilitate sealing and storing the drug therein, as described herein and shown in the accompanying drawings. However, those skilled in the art will appreciate that the vial may include only some of these feature structures and / or may include a plurality of other feature structures known in the art. The vials described herein are intended to represent certain exemplary embodiments only.

[0089] The opening 404 of the nasal spray device 400 through which the drug leaves the nasal spray device 400 is formed in the tip 408 of the distribution head 406 of the nasal spray device 400. Tip 408 is configured to be inserted into the patient's nostril. In an exemplary embodiment, tip 408 is configured to be inserted into the first nostril of the patient during the first operation stage of the nasal spray device 400, and inserted into the second nostril of the patient during the second operation stage of the nasal spray device 400. The first operation stage and the second operation stage involve two separate actuations of the nasal spray device 400, the first actuation corresponding to the first dose of the drug delivered and the second actuation corresponding to the second dose of the drug delivered. In some embodiments, the nasal spray device 400 is configured to be actuated only once to deliver a nasal spray. In some embodiments, the nasal spray device 400 is configured to be actuated three or more times to deliver three or more (e.g., four times, five times, six times, seven times, eight times, nine times, ten times, etc.) nasal sprays.

[0090] The dispensing head 406 includes a depth guide 410 configured to contact the patient's skin between the first and second nostrils of the patient such that the longitudinal axis of the dispensing head 406 is substantially aligned with the longitudinal axis of the nostril into which the tip 408 is inserted. Those skilled in the art will appreciate that the longitudinal axes may not be precisely aligned, but are considered to be substantially aligned due to any number of factors such as manufacturing tolerances and the sensitivity of the measuring equipment.

[0091] In an exemplary embodiment, as in Figure 44, the dispensing head 406 has a conical shape, wherein the dispensing head 406 has a smaller diameter at its distal end than at its proximal end where the opening 404 is located. The opening 404 having a relatively small diameter facilitates spraying the drug out of the opening 404, as will be appreciated by those skilled in the art. The spray chamber 412 through which the drug is configured to pass before leaving the opening 404 is located within the proximal portion of the conical dispensing head 406 away from the opening 404. As the drug quickly passes through the spray chamber 412, the spray chamber 412 facilitates the generation of a fine mist that passes through the opening 404 in a consistent spray pattern. Figure 4 Arrow 414 in shows the path that the drug travels from drug holder 402 and out of opening 404 .

[0092] In some embodiments, dispensing head 406 may include two tips 408, each having an opening 404 therein, such that nasal spray device 400 is configured to deliver a dose of medicament to both nostrils simultaneously in response to a single actuation.

[0093] Dispensing head 406 is configured to be pushed toward medication holder 402, e.g., by a user pushing down on depth guide 410 to depress, to actuate nasal spray device 400. In other words, dispensing head 406 is configured as an actuator so as to be actuated to drive medication from medication holder 402 out of nasal spray device 400. In an exemplary embodiment, nasal spray device 400 is configured to be self-administered, such that the user actuating nasal spray device 400 is a patient receiving medication from nasal spray device 400, but another person may also actuate nasal spray device 400 for delivery to another person.

[0094] like Figure 4 As shown by arrow 416 in FIG. 4 , actuation (e.g., depression) of the dispensing head 406 is configured to cause air to enter the drug holder 402. The air entering the drug holder 402 displaces the drug in the drug holder through the tube 418 and then into the metering chamber 420, which displaces the drug proximally through the cannula 422, through the spray chamber 412, and then out of the opening 404. In response to the release of the dispensing head 406, for example, the user stops pushing down on the dispensing head 406, the biasing spring 426 causes the dispensing head 406 to return to its default resting position to position the dispensing head 406 relative to the drug holder 402 for subsequent actuation and drug delivery.

[0095] Although the foregoing description relates to a specific example of a nasal spray device, the example is illustrative only. The description should not be considered limited to such a nasal spray device. Those skilled in the art understand that the nasal spray device 400 may include different features in different embodiments according to various requirements. For example, the nasal spray device 400 may lack a depth guide 410 and / or may include any one or more of a device indicator, a sensor, a communication interface, a processor, a memory, and a power source.

[0096] The nasal spray devices of the present disclosure can be used to administer any of a variety of drugs, such as ketamine (e.g., ), esketamine (e.g., and ), naloxone (e.g. ) and sumatriptan (e.g., )

[0097] Drug administration device

[0098] As will be appreciated from the foregoing, the various components of a drug delivery device are common to all such devices. These components form the basic components of a universal drug administration device. A drug administration device delivers a drug to a patient, wherein the drug is provided in a defined dosage form within the drug administration device.

[0099] Figure 5A is a generalized schematic diagram of such a universal drug administration device 501, and Figure 5B is an exemplary embodiment of such a universal drug administration device 500. Examples of the universal drug administration device 500 include injection devices (eg, auto-injectors, jet injectors, and infusion pumps), nasal spray devices, and inhalers.

[0100] like Figure 5A As shown, the drug administration device 501 includes in general form the features of a drug holder 10 and a dispensing mechanism 20. The drug holder 10 holds the drug in a dosage form to be administered. The dispensing mechanism 20 is configured to release the dosage form from the drug holder 10 so that the drug can be administered to a patient.

[0101] Figure 5BAnother generic drug administration device 500 is shown that includes a number of additional features. Those skilled in the art will appreciate that these additional features are optional to different embodiments and may be used in a variety of different combinations, such that the additional features may be present in or omitted from a given embodiment of a particular drug administration device depending on requirements such as the type of drug, the dosage form of the drug, the medical indication for treatment with the drug, safety requirements, whether the device is powered, whether the device is portable, whether the device is for self-administration, and many other requirements that will be apparent to those skilled in the art. Similar to Figure 5A The drug administration device 500 includes a housing 30 that houses a drug holder 10 and a dispensing mechanism 20.

[0102] The device 500 is provided with a trigger mechanism 50 for initiating the release of the drug from the drug holder 10 via the dispensing mechanism 20. The device 500 includes a feature of a metering / dosing mechanism 70 that measures out a set dose for release from the drug holder 10 via the dispensing mechanism 20. In this way, the drug administration device 500 can provide a known dose of a determined size. The device 500 includes a dose selector 60 that enables a user to set a dose volume of the drug to be dispensed by the metering mechanism 50. The dose volume can be set to a specific value of a plurality of predefined discrete dose volumes, or any value of a predefined dose volume within a dose volume range.

[0103] The device 500 may include a device operation prevention mechanism 40 or 25, which, when in a locked state, will prevent and / or stop the dispensing mechanism 20 from releasing the drug from the drug holder 10, and when in an unlocked state, will allow the dispensing mechanism 20 to release the drug dose from the drug holder 10. This can prevent accidental administration of the drug, for example, to prevent administration at an incorrect time or to prevent unintentional actuation. The device 500 also includes a dispensing mechanism protection mechanism 42, which prevents access to at least a portion of the dispensing mechanism 20, for example, for safety reasons. The device operation prevention mechanism 40 and the dispensing mechanism protection mechanism 42 can be the same component.

[0104] The device 500 may include a device indicator 85 configured to present information about the status of the drug administration device and / or the drug contained therein. The device indicator 85 may be a visual indicator such as a display screen, or an audio indicator. The device 500 includes a user interface 80, which may be configured to present information about the device 500 to a user of the device 500 and / or enable the user to control the device 500. The device 500 includes a device sensor 92, which is configured to sense information related to the drug administration device and / or the drug contained therein, such as dosage form and device parameters. For example, in an embodiment including a metering mechanism 70 and a dose selector 60, the embodiment may also include one or more device sensors 92, which are configured to sense one or more of the following: a dose selected by a user using the dose selector 60, a dose metered by the metering mechanism 70, and a dose dispensed by the dispensing mechanism 20. Similarly, an environmental sensor 94 is provided, which is configured to sense information related to the environment in which the device 500 exists, such as the temperature of the environment, the humidity of the environment, the location, and the time. There may be a dedicated location sensor 98 configured to determine the geographic location of the device 500, for example via satellite location determination such as GPS. The device 500 also includes a communication interface 99 that can communicate data about the device and / or medication that has been acquired from various sensors to the outside.

[0105] If desired, the device 500 includes a power source 95 for delivering electrical power to one or more electrical components of the device 500. The power source 95 can be a power source integral to the device 500 and / or a mechanism for connecting the device 500 to an external power source. The drug administration device 500 also includes a device computer system 90, which includes a processor 96 and a memory 97, which are powered by the power source 95 and communicate with each other and optionally with other electrical and control components of the device 500, such as the environmental sensor 94, the position sensor 98, the device sensor 92, the communication interface 99, and / or the indicator 85. The processor 96 is configured to obtain data acquired from the environmental sensor 94, the device sensor 92, the communication interface 99, the position sensor 98, and / or the user interface 80, and process the data to provide data output, for example, to the indicator 85 and / or the communication interface 99.

[0106] In some embodiments, the drug administration device 500 is packaged in a package 35. The package 35 may also include a combination of a processor 96, a memory 97, a user interface 80, a device indicator 85, a device sensor 92, a position sensor 98, and / or an environmental sensor 94 as described herein, and these may be located externally on the housing of the device 500.

[0107] Those skilled in the art will appreciate that the universal drug administration device 500 including the drug holder 10 and the dispensing mechanism 20 can be provided with the various optional features described above in a variety of different combinations. In addition, the drug administration device 500 can include more than one drug holder 10, optionally with more than one dispensing mechanism 20, such that each drug holder has its own associated dispensing mechanism 20.

[0108] Drug dosage form

[0109] Conventionally, drug administration devices utilize liquid dosage forms. However, it will be appreciated that other dosage forms are available.

[0110] One such common dosage form is a tablet. Tablets can be formed from a combination of drug and excipients compressed together. Other dosage forms are pastes, creams, powders, ear drops, and eye drops.

[0111] Additional examples of drug dosage forms include skin patches, drug eluting stents, and intrauterine devices. In these examples, the body of the device includes the drug and can be configured to allow the drug to be released in certain circumstances. For example, a skin patch may include a polymer composition containing the drug. The polymer composition allows the drug to diffuse out of the polymer composition and into the patient's skin. Drug eluting stents and intrauterine devices can operate in a similar manner. In this way, patches, stents, and intrauterine devices themselves can be considered as drug holders with associated dispensing mechanisms.

[0112] Any of these dosage forms may be configured to initiate drug release by certain conditions. This may allow the drug to be released at a desired time or location after the dosage form has been introduced into the patient. In particular, drug release may be initiated by an external stimulus. In addition, these dosage forms may be contained in a housing prior to administration, which may be in the form of a package. The housing may include some of the above-mentioned optional features that are utilized with the universal drug administration device 500.

[0113] The drug administered by the drug administration device of the present disclosure may be any substance that causes physiological or psychological changes in an organism when consumed. Examples of drugs that can be administered by the drug administration device of the present disclosure include 5-α-reductase inhibitors, 5-aminosalicylate, 5HT3 receptor antagonists, ACE inhibitors and calcium channel blockers, ACE inhibitors and thiazides, adamantane antivirals, adrenocortical steroids, adrenocortical steroid inhibitors, adrenal bronchodilators, hypertensive emergency drugs, pulmonary hypertension drugs, aldosterone receptor antagonists, alkylating agents, allergen preparations, α-glucosidase inhibitors, alternative medicines, anti-amoebic drugs, aminoglycoside antibiotics, aminopenicillins, aminosalicylate, AMPA receptor antagonists, amylin analogs, analgesic complexes, and sedatives. Combinations, analgesics, androgens and anabolic steroids, angiotensin converting enzyme inhibitors, angiotensin II inhibitors and calcium channel blockers, angiotensin II inhibitors and thiazides, angiotensin receptor blockers, angiotensin receptor blockers and enkephalinase inhibitors, anorectal preparations, anorectal agents, antacids, anthelmintics, antiangiogenic ophthalmic agents, anti-CTLA-4 monoclonal antibodies, anti-infectives, anti-PD-1 monoclonal antibodies, (central) antiadrenergics and thiazides, (peripheral) antiadrenergics and thiazides, centrally acting antiadrenergics, peripherally acting antiadrenergics, anti Androgens, antianginal drugs, antiarrhythmic drugs, antiasthmatic combination drugs, antibiotics / antineoplasty drugs, anticholinergic antiemetic drugs, anticholinergic antiparkinsonian drugs, anticholinergic bronchodilators, anticholinergic chronotropic drugs, anticholinergic / antispasmodic drugs, anticoagulant reversal agents, anticoagulants, antispasmodics, antidepressants, antidiabetic drugs, antidiabetic combination drugs, antidiabetic drugs, antidiarrheal drugs, antidiuretic hormones, antidote, antiemetic / antivertigo drugs, antifungal drugs, antigonadotropins, antigout drugs, antihistamines, antihyperlipidemic drugs, antihyperlipidemic combination drugs, antihypertensive combination drugs, antihyperuric acid drugs, antimalarials, antimalarial combination drugs, antimalarial quinolones, antimanic drugs, anti-metastatic drugs Anti-inflammatory drugs, anti ... Anticonvulsants, benzodiazepines beta-blockers and calcium channel blockers, beta-blockers and thiazides, beta-adrenergic blockers, beta-lactamase inhibitors, bile acid sequestrants, biologics, bisphosphonates, bone morphogenetic protein, bone resorption inhibitors, bronchodilator combination drugs, bronchodilators, calcimimetics, calcineurin inhibitors, calcitonin, calcium channel blockers, carbamate antispasmodics, carbapenems, carbapenem / beta-lactamase inhibitors, carbonic anhydrase inhibitors antispasmodics, carbonic anhydrase inhibitors, cardiac stress medications, cardioselective beta-blockers, cardiovascular drugs, catecholamines, cation exchange resins, CD20 monoclonal antibodies, CD30 monoclonal antibodies, CD33 monoclonal antibodies, CD38 monoclonal antibodies, CD52 monoclonal antibodies, CDK 4 / 6 inhibitors, central nervous system drugs, cephalosporins, cephalosporins / β-lactamase inhibitors, cerumen-lytics, CFTR combination drugs, CFTR potentiators, CGRP inhibitors, chelators, chemokine receptor antagonists, chloride channel activators, cholesterol absorption inhibitors, cholinergic agonists, cholinergic muscle stimulants, cholinesterase inhibitors, CNS stimulants, coagulation regulators, colony stimulating factors, contraceptives, adrenocorticotropic hormone, coumarins and indanediones, cox-2 inhibitors, decongestants, dermatological drugs, diagnostic radiopharmaceuticals, diarylquinolines, dibenzazepines antispasmodics, digestive enzymes, dipeptidyl peptidase 4 inhibitors, diuretics, dopaminergic antiparkinsonian drugs, drugs for alcohol dependence, echinocandins, EGFR inhibitors, estrogen receptor antagonists, estrogens, expectorants, factor Xa inhibitors, fatty acid derivative antispasmodics, fibric acid derivatives, first-generation cephalosporins, fourth-generation cephalosporins, functional bowel disease drugs, gallstone dissolving drugs, gamma-aminobutyric acid analogs, gamma-aminobutyric acid reuptake inhibitors, gastrointestinal drugs, general anesthetics, genitourinary drugs, GI stimulants, glucocorticoids, glucose-raising drugs, glycopeptide antibiotics, glycoprotein platelet inhibitors, glycylcyclines, gonadotropin-releasing hormone, gonadotropin-releasing hormone antagonists, gonadotropins, I group antiarrhythmics, group II antiarrhythmics, group III antiarrhythmics, group IV antiarrhythmics, group V antiarrhythmics, growth hormone receptor blockers, growth hormone, guanylate cyclase-C agonists, Helicobacter pylori eradicators, H2 antagonists, hedgehog pathway inhibitors, hematopoietic stem cell mobilizers, heparin antagonists, heparin, HER2 inhibitors, herbal products, histone deacetylase inhibitors, hormones, hormone / antineoplastic agents, hydantoin anticonvulsants, hydrazide derivatives, illegal (street) drugs, immunoglobulins, immunologic agents, immunostimulants, immunosuppressants, impotence agents, in vivo diagnostic biologics, incretin analogs, inhaled anti-infectives, inhaled corticosteroids, inotropes, insulin, insulin growth factors, integrase strand transfer inhibitors, interferons, interleukin inhibitors, interleukins, intravenous nutrition products, iodinated contrast media, ionized iodinated contrast media, iron products, ketolides, laxatives, antileprosy drugs, leukotriene modifiers, lincomycin derivatives, local injectable anesthetics, local injectable anesthetics and corticosteroids, loop diuretics, pulmonary surfactants, lymph stains, lysosomal enzymes, macrolide derivatives, macrolide drugs, magnetic resonance imaging contrast agents, mast cell stabilizers, medical gases, glinides, metabolic drugs, methylxanthines, mineralocorticoids, minerals and electrolytes, miscellaneous drugs, miscellaneous analgesics, miscellaneous antibiotics, miscellaneous anticonvulsants, miscellaneous antidepressants, miscellaneous antidiabetic drugs, miscellaneous antiemetics, Miscellaneous antifungals, miscellaneous antihyperlipidemics, miscellaneous antihypertensive combination drugs, miscellaneous antimalarials, miscellaneous antineoplastics, miscellaneous antiparkinsonian drugs, miscellaneous antipsychotics, miscellaneous antituberculosis drugs, miscellaneous antivirals, miscellaneous anxiolytics, sedatives and hypnotics, miscellaneous bone resorption inhibitors, miscellaneous cardiovascular drugs, miscellaneous central nervous system drugs, miscellaneous coagulation regulators, miscellaneous diagnostic dyes, miscellaneous diuretics, miscellaneous genitourinary drugs, miscellaneous GI drugs, miscellaneous hormones, miscellaneous metabolic drugs, miscellaneous ophthalmic drugs, miscellaneous otic drugs, miscellaneous respiratory drugs, miscellaneous sex hormones, miscellaneous topical drugs, miscellaneous unclassified drugs, miscellaneous vaginal drugs, mitotic inhibitors, monoamine oxidase inhibitors, oral and throat products, mTOR inhibitors, mucolytics, multikinase inhibitors,Muscle relaxants, mydriatics, narcotic analgesics, narcotic analgesics, nasal anti-infectives, nasal antihistamines and decongestants, nasal lubricants and lavages, nasal preparations, nasal steroids, natural penicillins, enkephalinase inhibitors, neuraminidase inhibitors, neuromuscular blockers, neuronal potassium channel openers, next generation cephalosporins, nicotinic acid derivatives, NK1 receptor antagonists, NNRTIs, non-cardioselective beta-blockers, non-iodinated contrast media, non-ionic iodinated contrast media, non-sulfonylureas, non-steroidal anti-inflammatory drugs, NS5A inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), health products, nutritional products, ophthalmic anesthetics, ophthalmic anti-infectives, ophthalmic anti-inflammatory drugs, ophthalmic antihistamines and decongestants, ophthalmic Diagnostic drugs, ophthalmic glaucoma drugs, ophthalmic lubricants and irrigations, ophthalmic preparations, ophthalmic steroids, ophthalmic steroids and anti-infectives, ophthalmic surgery drugs, oral nutritional supplements, other immunostimulants, other immunosuppressants, ear anesthetics, ear anti-infectives, ear preparations, ear steroids, ear steroids and anti-infectives, oxazolidinedione antispasmodics, oxazolidinedione antibiotics, parathyroid hormone and analogs, PARP inhibitors, PCSK9 inhibitors, penicillinase-resistant penicillins, penicillins, peripheral opioid receptor antagonists, peripheral opioid receptor mixed agonists / antagonists, peripheral vasodilators, peripherally acting anti-obesity drugs, phenothiazine antiemetics, phenothiazine antipsychotics, phenylpiperazine antidepressants, phosphate binders, PI3K inhibitors, plasma expanders, platelet aggregation inhibitors, platelet stimulants, polyene drugs, potassium-sparing diuretics and thiazides, potassium-sparing diuretics, probiotics, progesterone receptor modulators, progestin preparations, prolactin inhibitors, prostaglandin D2 antagonists, protease inhibitors, protease-activated receptor-1 antagonists, proteasome inhibitors, proton pump inhibitors, psoralens, psychotherapeutic drugs, psychotherapeutic combination drugs, purine nucleosides, pyrrolidine anticonvulsants, quinolones, radiocontrast agents, radiation adjuvants, radiation therapy drugs, radiation co-operators, radiopharmaceuticals, recombinant human erythropoietin, renin inhibitors, respiratory system drugs, respiratory inhalation products, rifamycin derivatives, salicylates, sclerosing drugs, second-generation cephalosporins, select Estrogen receptor modulators, selective immunosuppressants, selective phosphodiesterase-4 inhibitors, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, serotonin-containing neural tube enterocyte regulators, sex hormone combination drugs, sex hormones, SGLT-2 inhibitors, skeletal muscle relaxant combination drugs, skeletal muscle relaxants, smoking cessation drugs, somatostatin and somatostatin analogs, spermicides, statins, sterile irrigation solutions, streptogramins, streptomyces derivatives, succinimide antispasmodics, sulfonamides, sulfonylureas, synthetic ovulation stimulants, tetracyclic antidepressants, tetracyclines, therapeutic radiopharmaceuticals, therapeutic vaccines, thiazide diuretics, thiazolidinediones, thioxanthenes, third-generation cephalosporins,Thrombin inhibitors, thrombolytics, thyroid medications, TNFα inhibitors, labor suppressants, topical acne medications, topical medications, topical allergy diagnostics, topical anesthetics, topical anti-infectives, topical anti-rosacea medications, topical antibiotics, topical antifungals, topical antihistamines, topical antineoplastics, topical antipsoriatics, topical antivirals, topical astringents, topical debridements, topical depigmenting agents, topical emollients, topical keratolytics, topical nonsteroidal anti-inflammatory drugs, topical photochemotherapeutics, topical rubefacients, topical steroids, topical steroids and anti-infectives, transthyretin stabilizers, triazine antispasmodics, tricyclic antidepressants, trifunctional monoclonal antibodies, ultrasound contrast agents, upper respiratory tract combination drugs, urea antispasmodics, urea cycle disorder drugs, urinary anti-infectives, urinary antispasmodics, urinary pH regulators, uterotonics, combination vaccines, vaginal anti-infectives, vaginal preparations, vasodilators, vasopressin antagonists, vasopressors, VEGF / VEGFR inhibitors, viral vaccines, viscosupplements, vitamin and mineral combination drugs, vitamins or VMAT2 inhibitors. The drug administration device of the present disclosure can administer drugs selected from the following: epinephrine, rebif, etanercept, enrofloxacin, atropine, pralidoxime chloride, diazepam, insulin, atropine sulfate, avibactam sodium, bendamustine hydrochloride, carboplatin, daptomycin, epinephrine, levetiracetam, oxaliplatin, paclitaxel, pantoprazole sodium, treprostinil, vasopressin, voriconazole, zoledronic acid, mometasone, fluticasone, ciclesonide, budesonide, beclomethasone, vilanterol, salmeterol, formoterol, umeclidinium bromide, glycopyrrolate, tiotropium bromide, aclidinium bromide, indacaterol, salmeterol and olodaterol.

[0114] As mentioned above, a drug administration device may be used to deliver any of a variety of drugs. Examples of drugs that may be delivered using a drug administration device as described herein include (Infliximab), (Ustekinumab), (golimumab), Simponi (golimumab), (daratumumab), (guselkumab), (epoetin alfa), Risperdal (risperidone), Invega (Palipidone Palmitate), (esketamine), ketamine, and Invega (Palipidone palmitate).

[0115] Drug Shell

[0116] As described above, the dosage form can be provided in a holder suitable for the particular dosage form utilized. For example, a drug in a liquid dosage form can be held in a holder in the form of a vial with a stopper or in a syringe with a plunger prior to administration. A drug in a solid or powder dosage form (e.g., as a tablet) can be contained in a housing that is arranged to securely hold the tablet prior to administration.

[0117] The housing may include one or more drug holders, wherein each holder contains a dosage form, for example, the drug may be in tablet dosage form, and the housing may be in the form of a blister pack, wherein a tablet is held in each of the plurality of holders. The holders are in the form of recesses in the blister pack.

[0118] Figure 6 A housing 630 is depicted that includes a plurality of medication holders 610, each containing a dosage form 611. The housing 630 may have at least one environmental sensor 94 configured to sense information related to the environment in which the housing 630 exists, such as the temperature, time, or location of the environment. The housing 630 may include at least one device sensor 92 configured to sense information related to medications contained in the dosage forms 611 within the holders 610. There may be a dedicated location sensor 98 configured to determine the geographic location of the housing 630, for example, via satellite location determination, such as GPS.

[0119] The housing 630 may include an indicator 85 configured to present information to a user of the medication housing regarding the status of the medication in dosage form 611 contained within the holder 610. The housing 630 may also include a communication interface 99 that may communicate information to the outside via wired or wireless data transfer of data related to the medication housing 630, the environment, time or location, and / or the medication itself.

[0120] If desired, the housing 630 may include a power source 95 for delivering electrical power to one or more electrical components of the housing 630. The power source 95 may be a power source integral to the housing 630 and / or a mechanism for connecting the housing 630 to an external power source. The housing 630 may also include a device computer system 90, which includes a processor 96 and a memory 97, which are powered by the power source 95 and communicate with each other and optionally with other electrical and control components of the housing 630, such as environmental sensors 94, position sensors 98, device sensors 92, communication interfaces 99, and / or indicators 85. The processor 96 is configured to obtain data acquired from the environmental sensors 94, the device sensors 92, the communication interfaces 99, the position sensors 98, and / or the user interface 80, and process the data to provide data outputs to the indicators 85 and / or the communication interfaces 99, for example.

[0121] The housing 630 may be in the form of a packaging. Alternatively, there may be an additional packaging to contain and surround the housing 630.

[0122] The retainer 610 or an attached packaging itself may include one or more of the device sensor 92, environmental sensor 94, indicator 85, communication interface 99, power source 95, position sensor 98 and device computer system as described above, the device computer system including a processor 96 and memory 85.

[0123] Electronic Communications

[0124] As mentioned above, the communication interface 99 may be associated with the drug administration device 500 or drug housing 630 by being included within or on the housing 30, 630 or alternatively within the packaging 35. Such a communication interface 99 may be configured to communicate with a remote computer system such as Figure 7 The central computer system 700 shown communicates with the Figure 7 As shown, the communication interface 99 associated with the drug administration device 500 or the housing 630 is configured to communicate with the central computer system 700 via a communication network 702 from any number of locations such as a medical facility 706 (e.g., a hospital or other medical care center), a residential base 708 (e.g., a patient's home or office or a caregiver's home or office), or a mobile location 710. The communication interface 99 can be configured to access the system 700 via a wired and / or wireless connection to the network 702. In an exemplary embodiment, Figure 6 The communication interface 99 is configured to wirelessly access the system 700, such as via a Wi-Fi connection, which may facilitate accessibility to the system 700 from nearly anywhere in the world.

[0125] Those skilled in the art will appreciate that the system 700 may include security features such that aspects of the system 700 available to any particular user may be determined based on, for example, the identity of the user and / or the location from which the user is accessing the system. To this end, each user may have a unique user name, password, biometric data, and / or other security credentials to facilitate access to the system 700. Received security parameter information may be checked against a database of authorized users to determine whether the user is authorized and the extent to which the user is permitted to interact with the system, view information stored in the system, and the like.

[0126] Computer Systems

[0127] As discussed herein, one or more aspects or features of the subject matter described herein, such as components of the central computer system 700, processor 96, power source 95, memory 97, communication interface 99, user interface 80, device indicator 85, device sensor 92, environmental sensor 94, and position sensor 98, may be implemented in digital electronic circuits, integrated circuits, specially designed application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), computer hardware, firmware, software, and / or combinations thereof. These various aspects or features may include specific implementations in one or more computer programs that are executable and / or interpretable on a programmable system including at least one programmable processor, which may be special or general purpose, coupled to receive data and instructions from and transmit data and instructions to a storage system, at least one input device, and at least one output device. A programmable system or computer system may include clients and servers. Clients and servers are typically remote from each other and typically interact through a communication network such as the Internet, a wireless wide area network, a local area network, a wide area network, or a wired network. The relationship of client and server is obtained by virtue of computer programs running on respective computers having a client-server relationship to each other.

[0128] These computer programs (also referred to as programs, software, software applications, components or codes) include machine instructions for programmable processors and can be implemented in high-level programming languages, object-oriented programming languages, functional programming languages, logical programming languages ​​and / or in assembly / machine languages. As used herein, the term "machine-readable medium" refers to any computer program product, device and / or device (e.g., disk, optical disk, memory, programmable logic device (PLD)) used to provide machine instructions and / or data to a programmable processor, including a machine-readable medium that receives machine instructions as machine-readable signals. The term "machine-readable signal" refers to any signal used to provide machine instructions and / or data to a programmable processor. A machine-readable medium can store such machine instructions in a non-transient manner, such as a non-transient solid-state memory or a magnetic hard drive or any equivalent storage medium. Alternatively or in addition thereto, a machine-readable medium can store such machine instructions in a transient manner, such as a processor cache or other random access memory associated with one or more physical processor cores.

[0129] To enable interaction with a user, one or more aspects or features of the subject matter described herein, such as a user interface 80 (which may be integrated or separate from the applicator 500 or housing 630), may be implemented on a computer having a display screen for displaying information to a user, such as, for example, a cathode ray tube (CRT) or a liquid crystal display (LCD) or a light emitting diode (LED) monitor. The display screen may allow input thereto directly (e.g., as a touch screen) or indirectly (e.g., via an input device, such as a keypad or voice recognition hardware and software). Other types of devices may also be used to provide interaction with a user. For example, the feedback provided to the user may be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user may be received in any form, including, but not limited to, sound, voice, or tactile input. As described above, in addition to the user interface 80, the feedback may be provided via one or more device indicators 85. The device indicator 85 may interact with one or more of the device sensor 92, the environmental sensor 94, and / or the position sensor 98 to provide the feedback or receive input from the user.

[0130] Figure 8 An exemplary embodiment of a computer system 700 depicted as computer system 800 is shown. The computer system includes one or more processors 896 configured to control the operation of the computer system 800. The processor 896 may include any type of microprocessor or central processing unit (CPU), including a programmable general-purpose or special-purpose microprocessor and / or any of a variety of proprietary or commercially available single-processor systems or multi-processor systems. The computer system 800 also includes one or more memories 897 configured to provide temporary storage for code to be executed by the processor 896 or for data obtained from one or more users, storage devices, and / or databases. The memory 897 may include read-only memory (ROM), flash memory, one or more random access memories (RAM) (e.g., static RAM (SRAM), dynamic RAM (DRAM), or synchronous DRAM (SDRAM)), and / or a combination of memory technologies.

[0131] The various elements of the computer system are coupled to a bus system 812. The bus system 812 shown is an abstract concept that represents any one or more separate physical buses, communication lines / interfaces, and / or multi-point or point-to-point connections connected through appropriate bridges, adapters, and / or controllers. The computer system 800 also includes one or more network interfaces 899 (also referred to herein as communication interfaces), one or more input / output (IO) interfaces 880, and one or more storage devices 810.

[0132] The communication interface 899 is configured to enable the computer system to communicate with a remote device (e.g., other computer systems and / or devices 500 or housing 630) via a network, and may be, for example, a remote desktop connection interface, an Ethernet adapter, and / or other local area network (LAN) adapters. The IO interface 880 includes one or more interface components to connect the computer system 800 to other electronic devices. For example, the IO interface 880 may include a high-speed data port, such as a universal serial bus (USB) port, a 1394 port, Wi-Fi, Bluetooth, etc. In addition, the computer system may be accessible to a human user, and therefore the IO interface 880 may include a display, a speaker, a keyboard, a pointing device, and / or various other video, audio, or alphanumeric interfaces. The storage device 810 includes any conventional media for storing data in a non-volatile and / or non-transient manner. Therefore, the storage device 810 is configured to keep data and / or instructions in a persistent state, wherein the value is retained despite interruption of power to the computer system. The storage device 810 may include one or more hard disk drives, flash drives, USB drives, optical disk drives, various media cards, disks, optical disks, and / or any combination thereof, and may be directly connected to a computer system or remotely (such as via a network) connected to the computer system. In an exemplary embodiment, the storage device 810 includes a tangible or non-transitory computer-readable medium configured to store data, such as a hard disk drive, flash drive, USB drive, optical disk drive, media card, disk, or optical disk.

[0133] Figure 8 The elements shown in the figure may be some or all of the elements of a single physical machine. In addition, not all elements shown need to be located on or in the same physical machine.

[0134] The computer system 800 may include a web browser for: retrieving web pages or other markup language streams, presenting those pages and / or streams (visually, audibly, or otherwise), executing scripts, controls, and other code on those pages / streams, accepting user input with respect to those pages / streams (e.g., for the purpose of completing input fields), issuing Hypertext Transfer Protocol (HTTP) requests with respect to those pages / streams or otherwise (e.g., for submitting server information from completed input fields), etc. The web pages or other markup languages ​​may be Hypertext Markup Language (HTML) or other conventional forms, including embedded Extensible Markup Language (XML), scripts, controls, etc. The computer system 800 may also include a web server for generating and / or delivering web pages to client computer systems.

[0135] like Figure 7 As shown above Figure 8The computer system 800 may form part of a central computer system 700 that communicates with one or more of the device computer systems 90 of one or more individual drug administration devices 500 or housings 630. Data, such as operating data of a device 500 or housing 630, medical data of a patient acquired by such a device 500 or housing 630, may be exchanged between the central computer system 700 and the device computer system 90.

[0136] As mentioned, the computer system 800 described above may also form part of a device computer system 90 that is integrated into or proximate to the drug administration device 500 or housing 630. In this regard, the one or more processors 896 correspond to the processor 96, the network interface 799 corresponds to the communication interface 99, the IO interface 880 corresponds to the user interface 80, and the memory 897 corresponds to the memory 97. Furthermore, additional storage devices 810 may also be present in the device computer system 90.

[0137] In an exemplary embodiment, the computer system 800 may form the device computer system 90 as a single unit, such as contained within a single drug administration device housing 30, contained within a single package 35 for one or more drug administration devices 500, or a housing 630 including a plurality of drug holders 610. The computer system 800 may form the central computer system 700 as a single unit, a single server, or a single tower.

[0138] The individual units may be modular such that various aspects thereof may be swapped in and out as needed for, e.g., upgrades, replacements, maintenance, etc., without disrupting the functionality of any other aspects of the system. Thus, the individual units may also be expandable, with the ability to be added as additional modules and / or additional functionality as desired and / or to improve upon existing modules.

[0139] The computer system may also include any of a variety of other software and / or hardware components, including (as an example) an operating system and a database management system. Although an exemplary computer system is depicted and described herein, it should be understood that this is for reasons of generality and convenience. In other embodiments, the architecture and operation of the computer system may be different from those shown and described herein. For non-limiting examples, the memory 897 and the storage device 810 may be integrated together, or the communication interface 899 may be omitted if communication with another computer system is not required.

[0140] Specific implementation

[0141] It is desirable to monitor compliance with guidelines related to medications administered to patients in various dosage forms. This can ensure that correct procedures are followed and that incorrect and potentially dangerous methods are avoided. Additionally, this can enable optimization of medication administration to patients.

[0142] Furthermore, it may be desirable to provide a drug administration system that does not require patients themselves to monitor their response to a drug dosing regimen and subsequently adjust their drug dosing regimen. Furthermore, it may be desirable to provide a drug administration system that takes into account factors that not only affect a patient's response to a drug dosing regimen but also change over time.

[0143] Fig. 9 A drug administration device 500 ( Figure 5B and Figure 7 ) and computer system 800( Figure 8 ) of an exemplary embodiment of a drug administration system. Specific examples of drug administration devices 500 are discussed herein, such as an automatic injector 100 ( Figure 1 )、Infusion Pump 200( Figure 2 ) and Inhaler 300( Figure 3 ), and possibly other types such as nasal spray devices. The drug administration device 500 includes a communication interface 99 configured to communicate with a communication interface 899 of the computer system 800. The drug administration system also includes at least one sensor 93, the at least one sensor being configured to sense a parameter and thereby obtain sensor data, and to transmit the sensor data to the drug administration device 500. The drug administration device 500 is configured to utilize a first drug administration regimen when the drug is delivered from the drug administration device 500 to the patient, and to determine a second drug administration regimen for delivering the drug from the drug administration device 500 to the patient. The second drug administration regimen depends on the administration data from the computer system 800 and the sensor data from the at least one sensor 93. The sensor data may be obtained by the at least one sensor 93 during and / or after the drug is delivered according to the first drug administration regimen. The drug administration device 500 is also configured to utilize the second drug administration regimen when delivering the drug from the drug administration device 500 to the patient after the first drug administration regimen has been used to deliver the drug from the drug administration device 500 to the patient.

[0144] The sensor data can be correlated to factors that affect the patient's response to the first medication dosing regimen. In this way, the medication administration system can better optimize the patient's dosing regimen by taking this data into account without requiring the patient to monitor and process the data themselves (which may be time-consuming, confusing, and / or impossible due to the inability to accurately measure this factor).

[0145] The first drug dosing regimen may depend on dosing data transmitted from the computer system 800 to the drug administration device 500. The transmission enables the first drug dosing regimen to be specified via the computer system 800. Thus, the drug administration device 500 may be configured to determine the first drug dosing regimen for delivering the drug to the patient before utilizing the first drug dosing regimen when the drug is delivered to the patient. Alternatively, the first dosing regimen may be a default dosing regimen contained on the drug administration device 500 (e.g., stored in its memory 97). The first dosing regimen may exist on the drug administration device 500 from the time the drug administration device 500 is manufactured or at least before the user (e.g., the patient, the patient's caregiver, or a medical professional) receives the drug administration device 500 for use with the patient.

[0146] The drug administration data may be associated with data indicating drug administration parameters to be utilized by the drug administration device 500 when delivering the drug from the drug administration device to the patient. In this manner, the drug administration data may be used as a basis for determining a first drug administration regimen. A drug administration regimen is a collection of one or more drug administration parameters associated with drug delivery. Examples of drug administration parameters include at least one of a drug delivery rate, a drug delivery volume, a drug delivery duration, a drug delivery frequency, and a timing of drug delivery. As described above, each of the first drug administration regimen and the second drug administration regimen is composed of one or more of such drug administration parameters.

[0147] Each of the first drug administration regimen and the second drug administration regimen is an algorithm stored in the memory 97 of the drug administration device 500, which can be executed by the processor 96 on the drug administration device 500. The algorithm is stored in the form of one or more sets of multiple data points that define and / or represent instructions, notifications, signals, etc. to control the functions of the device 500 and the administration of the drug from the device 500. As discussed herein, data received as multiple data points by the drug administration device 500, for example, via its communication interface 99, can be used, for example, by the processor 96 to change at least one drug administration parameter of the algorithm. The at least one drug administration parameter is among the data points of the algorithm, and thus each drug administration parameter can be changed by changing one or more of the stored multiple data points of the algorithm.

[0148] The data received by the drug administration device 500, for example, from the computer system 800 and from the at least one sensor 93, may identify the drug administration parameters to be changed and the updated values ​​of each parameter, or the data received by the drug administration device 500 may include input parameters, and the drug administration device 500 is configured to use these input parameters when performing calculations (e.g., when executing a calculation algorithm stored in the memory 97) to determine the correct value of each drug administration parameter in the algorithm of the drug administration regimen. The calculation algorithm is stored in the form of one or more sets of multiple data points. The calculation algorithm utilized by the drug administration device 500 may already exist in the memory 97 before receiving the administration data. Alternatively, the calculation algorithm utilized by the drug administration device 500 may be provided as part of the administration data, which also includes the input parameters.

[0149] Input parameters used as part of the determination of drug administration parameters involved in executing a computational algorithm may include clinical data, such as patient age, patient weight, patient urine pH, patient temperature, the condition of the patient being treated, and the presence of other disease states. These input parameters may include data related to the activity or toxicity of the drug, such as the minimum therapeutic dose, the maximum therapeutic dose, and side effects. These input parameters may include pharmacokinetic data, such as the absorption rate, distribution rate, metabolism, and excretion rate of a specific drug to be delivered to the patient. The drug administration algorithm may take these parameters as input and calculate a drug administration regimen.

[0150] After the at least one drug administration parameter has been changed, a subsequent execution of the algorithm administers another dose of the drug according to the algorithm, which reflects the current drug administration regimen, whether the first drug administration regimen or the second drug administration regimen (or a drug administration regimen subsequent to the second drug administration regimen, as drug administration regimens may be changed any number of times to help optimize drug delivery over time). Alternatively, each changed algorithm, e.g., each different drug administration regimen, may be stored in the memory 97, with the processor 96 executing the most recent of the stored drug administration regimens to cause drug delivery from the drug administration device 500. Storing each of the drug administration regimens may require a larger memory 97 than storing only one drug administration regimen at a time, but storing each of the drug administration regimens simultaneously in the memory 97 facilitates analysis of drug delivery, patient compliance, and / or patient treatment.

[0151] By allowing the drug dosing regimen to change over time, drug delivery over time can be managed for the patient, for example, by a medical professional providing input to the system 700 for drug delivery changes to increase the beneficial outcome of the drug. Changes to the at least one drug dosing parameter are automatic to improve patient outcomes. Thus, the drug administration system can be configured to facilitate patient-based personalized medication to provide an intelligent system for drug delivery.

[0152] As described above, the drug administration data may include a direct indication of drug administration parameters to be utilized by the drug administration device 500, or alternatively, the drug administration data may include input parameters used by the drug administration device 500 as part of a determination calculation performed on the drug administration device 500. Either approach enables the drug administration device 500 to modify the current drug administration regimen to improve the effectiveness of the drug administration regimen. Similarly, the sensor data may include a direct indication of drug administration parameters to be utilized by the drug administration device 500, or alternatively, the sensor data may include input parameters used by the drug administration device 500 as part of a determination calculation performed on the drug administration device 500.

[0153] As mentioned herein, the drug administration device 500 is also configured to determine a second drug administration regimen. The second drug administration regimen is calculated based on a plurality of inputs as described above (e.g., based on administration data from the computer system 800 and / or sensor data from at least one sensor 93). The plurality of inputs may also include user input data input to the drug administration device 500 via the user interface 80. The plurality of inputs may be used to adjust the second drug administration regimen relative to the first drug administration regimen, thereby helping to optimize the drug administration regimen for the patient.

[0154] The computer system 800 can be configured to determine a second medication dosing regimen, similar to that discussed above with respect to the use of an algorithm by a medication administration device to determine a second medication dosing regimen, and the computer system 800 can be configured to send the second medication dosing regimen to the medication administration device 500. In this manner, the medication administration device 500 can have a smaller and / or less expensive memory 97 and / or processor 96, since the medication administration device 500 would need to be configured to store and execute the second medication dosing regimen without needing to additionally receive sensor data or perform any calculations to determine the second medication dosing regimen (other than recognizing that the second medication dosing regimen has replaced the first medication dosing regimen and become the current medication dosing regimen). To facilitate the computer system determining the second medication dosing regimen, sensor data obtained by the at least one sensor 93 during and / or after delivering medication according to the first medication dosing regimen can be transmitted from the at least one sensor 93 to the computer system 800, for example using its communication interface. The computer system 800 also has dosing data that can be used to determine the second medication dosing regimen.

[0155] The at least one sensor 93 may include one or more different types of sensors, and may include one or more sensors of the same type. Examples of sensors that may be used as the at least one sensor 93 in any combination include: patient monitoring sensors 91 ( Fig.11A ), which is configured to obtain sensor data related to the patient's condition; device sensor 92 ( Figure 5B ), which is configured to obtain sensor data related to the drug administration device 500 and / or the drug contained therein; environmental sensor 94 ( Figure 5B ), which is configured to obtain sensor data related to the environment in which the drug administration device 500 exists; and position sensor 98 ( Figure 5B ), which is configured to obtain sensor data related to the geographic location of the drug administration device 500. The at least one sensor 93 can be part of the drug administration device 500, or as Fig. 9 In the illustrated embodiment, at least one sensor 93 may be a different element from the drug administration device 500. When the at least one sensor 93 includes a plurality of sensors, one or more of the sensors may be mounted on the drug administration device 500 and / or one or more of the sensors may be a different element from the drug administration device 500.

[0156] The patient monitoring sensor 91 is configured to obtain sensor data related to the patient's condition. The sensor data related to the patient's condition may include any one or more of the following: the patient's blood oxygen level (e.g., using a blood oxygen sensor), the patient's blood glucose level (e.g., using a glucose monitor, etc.), the patient's blood pressure (e.g., using a blood pressure monitor, etc.), the patient's heart rate (e.g., using a heart rate monitor, etc.), the patient's body temperature, the patient's metabolic rate, the patient's allergic reactions, the duration and / or severity of exacerbations of asthma symptoms, the time required for a physiological reaction to occur in response to drug administration, the extent of the patient's physiological reaction to drug administration, tissue thickness, tissue density, and patient weight. For example, an impedance sensor is a patient sensor that can be used to sense tissue thickness and tissue density.

[0157] The device sensor 92 is configured to obtain sensor data related to the drug administration device 500 and / or the drug contained therein, which sensor data, in exemplary embodiments, may include one or more of the orientation of the drug administration device 500 (e.g., using a gyroscope, accelerometer, tilt / angle switch (mercury-free), position sensor, etc.) and the temperature of the drug in the drug administration device 500 (e.g., using a temperature sensor such as a thermistor, thermocouple, thermal resistor, etc.), as orientation and temperature may be particularly relevant to the drug administration regimen.

[0158] Environmental sensors 94 are configured to obtain sensor data related to the environment in which drug administration device 500 is present, which in an exemplary embodiment may include sensors configured to collect sensor data related to one or more of the following: air quality of the environment in which device 500 is present (e.g., using a UV sensor, etc.), pollen count of the environment in which device 500 is present (e.g., using a pollen sensor, etc.), humidity of the environment in which device 500 is present (e.g., using a thermistor, hygrometer, etc.), and temperature of device 500 (e.g., using a temperature sensor such as a thermistor, thermocouple, thermistor, etc.). Measures of air quality include measures of nitrogen dioxide, ground-level ozone, carbon monoxide, and particulates.

[0159] The drug administration device 500 can be configured to determine a first drug administration regimen for delivering a first drug to a patient, and to determine a second drug administration regimen for delivering a second drug to a patient, wherein the second drug is different from the first drug. The drug administration device 500 can be configured to deliver both the first drug and the second drug to the patient. For example, the first drug can be a drug for intermittent release therapy, and the second drug can be a drug for conventional preventive therapy. Drugs suitable for these uses are known to those skilled in the art. The drug administration device 500 can be configured to adjust each of the first drug administration regimen and the second drug administration regimen as described above, so that the delivery of each of the first drug and the second drug can be optimized for the patient.

[0160] Fig. 10A yes Fig. 9 A schematic diagram of an exemplary embodiment of a drug administration system of Fig. 10A In the illustrated embodiment, the drug administration device 500 is an inhaler 300 ( Figure 3 ). Sensor 91( Fig. 9 ) in the illustrated embodiment includes: a first patient monitoring sensor 91a, which is configured to obtain sensor data related to the patient's blood oxygen level; a second patient monitoring sensor 91b, which is configured to obtain data related to the patient's blood pressure (BP); a third patient monitoring sensor 91c, which is configured to obtain data related to the patient's heart rate; an environmental sensor 94( Figure 5B ), which is configured to obtain data related to the air quality and pollen count of the environment in which the inhaler 300 is present; and a fourth patient monitoring sensor 91d, which is configured to obtain sensor data related to the patient's weight (body mass). In use, sensors 91a, 91b, 91c, 91d and 94 obtain data and transmit these data to the inhaler 300 as described above.

[0161] Therefore, as mentioned above Fig. 9 As discussed, Fig. 10A The inhaler 300 of the embodiment of the present invention is configured to utilize a first drug administration regimen to deliver the drug from the inhaler to the patient. The inhaler 300 is configured to subsequently determine a second drug administration regimen for delivering the drug from the inhaler to the patient, wherein the second drug administration regimen depends on the administration data from the computer system 800 and the sensor data from the patient monitoring sensors 91a, 91b, 91c, 91d and the environmental sensor 94, which are obtained by the sensors 91a, 91b, 91c, 91d and 94 during and / or after the drug is delivered according to the first drug administration regimen. The inhaler 300 is also configured to utilize the second drug administration regimen when delivering the drug to the patient at a certain moment after the second drug administration regimen is determined according to the first administration regimen.

[0162] Fig. 10B A schematic diagram of an example of data obtained by a first patient monitoring sensor 91a, a second patient monitoring sensor 91b, an environmental sensor 94, and a fourth body monitoring sensor 91d and three medication dosing regimen adjustments occurring at the times indicated by the vertical dashed lines is shown. The first of these medication dosing regimen adjustments occurs in response to changes that occur when a patient wearing or otherwise using sensors 91a, 91b, 91c, 91d, and 94 (e.g., as part of a smartwatch worn by the patient, as part of an implanted device, as part of a sensor attached to the patient's skin surface, as part of an inhaler 300 carried by the patient, etc.) is out and experiences changes in pollen levels and air quality. For this first of these medication dosing regimen adjustments, the inhaler 300 is configured to adjust the medication dosing regimen depending on sensor data indicating increased pollen levels and decreased air quality due to an increase in the amount of particulate matter, for example, and the extent of the patient's response to the increased pollen levels and air quality, as indicated by measurements of blood oxygen levels (which decrease) and blood pressure (which also decreases). Thus, the adjusted medication dosing regimen specifies an increased medication dose compared to the medication dose of the first medication dosing regimen before the patient was out of the hospital in order to better control the patient's symptoms. No medication dose would be delivered to the patient using either of the first two medication dosing regimens.

[0163] The second of these medication dosing regimen adjustments occurs in response to changes that occur while the patient, wearing or otherwise using sensors 91a, 91b, 91c, 91d, 94, is outdoors mowing the grass (e.g., mowing the lawn). For this second of these medication dosing regimen adjustments, the inhaler 300 is configured to adjust the medication dosing regimen based on sensor data that indicates increased pollen levels and the extent of the patient's response to the increased pollen levels, and reflects the mowing activity as indicated by measurements of blood oxygen levels (which increase) and blood pressure (which decreases). Thus, the adjusted medication dosing regimen specifies an increased medication dose compared to the medication dose of the previous medication dosing regimen in order to better control the patient's symptoms. The medication dose is delivered to the patient according to the medication dosing regimen, such as Fig. 10B This is shown as “actual application” marked on the graph.

[0164] The third of these medication dosing regimen adjustments is in response to changes in medication dose (e.g. Fig. 10B The inhaler 300 may be configured to adjust the medication dosage regimen based on the sensor data, which reflects the medication administration as indicated by the measurement results of the blood oxygen level (which rises) and the blood pressure (which rises). Therefore, the adjusted medication dosage regimen specifies a reduced medication dosage compared to the medication dosage of the previous medication dosage regimen in order to better control the patient's symptoms. No medication dosage will be delivered to the patient using the adjusted medication dosage regimen. After the third medication dosage regimen adjustment, the medication dosage regimen may be adjusted any number of times to continue to better control the patient's symptoms.

[0165] Optionally, as described above with respect to Fig. 9 As discussed, the inhaler 300 may be configured to determine the patient's Fig. 10B An initial drug dosing regimen in the drug, wherein the initial drug dosing regimen depends on the dosing data.

[0166] exist FIG. 11A to FIG. 13B In an embodiment, patient comfort and efficacy of a drug dosing regimen may be improved by enabling a drug administration device to adjust one or more of the following factors: a discharge nozzle advancement depth of a discharge nozzle of the drug administration device during delivery of the drug from the drug administration device to the patient, a discharge nozzle velocity of the discharge nozzle during delivery of the drug from the drug administration device to the patient, and a discharge nozzle acceleration of the discharge nozzle during delivery of the drug from the drug administration device to the patient.

[0167] The discharge nozzle advancement depth during drug delivery is the maximum depth that the discharge nozzle is configured to extend into the patient during the entire drug delivery event (from when the discharge nozzle is first extended into the patient to when the discharge nozzle is withdrawn). Figure 1 In an automatic injector 100 , during delivery of a drug from the automatic injector to a patient, the discharge nozzle of the automatic injector may be advanced to a depth within a range of 2 mm to 25 mm below the surface of the patient's skin.

[0168] The discharge nozzle velocity during drug delivery is the maximum velocity that the discharge nozzle is configured to travel while the discharge nozzle is extended into the patient during the entire drug delivery event (from when the discharge nozzle is first extended into the patient to when the discharge nozzle is withdrawn). Figure 1 In the case of an automatic injector 100 , the discharge nozzle velocity of the automatic injector discharge nozzle may be in the range of 0.01 m / s to 0.2 m / s during delivery of the drug from the automatic injector to the patient.

[0169] The discharge nozzle acceleration during drug delivery is the maximum acceleration that the discharge nozzle is configured to accelerate during the entire drug delivery event (from when the discharge nozzle is first extended into the patient to when the discharge nozzle exits the patient). Figure 1 The automatic injector 100), during the delivery of the drug from the automatic injector to the patient, the discharge nozzle speed of the automatic injector discharge nozzle can be 0.002m / s 2 Up to 0.2m / s 2 within the range.

[0170] Fig.11A is a computer system 800 ( Figure 8 and Fig. 9 )、Drug administration device 500( Figure 5B , Figure 7 and Fig. 9 ) and at least one patient monitoring sensor 91 (such as an impedance sensor configured to detect the density and / or thickness of patient tissue), wherein the drug administration device in this embodiment includes an automatic injector 100 ( Figure 1 ). The drug administration system is generally similar to that described above with respect to Fig. 9 The sensor 91 may be positioned, for example, on a portion of the automatic injector 100, such as Fig.11A As shown, the sensor is in direct contact with the injection site. The first drug administration regimen and the second drug administration regimen of this embodiment specify at least a drug delivery volume and a drug delivery rate, for example, the drug administration parameters of the drug administration regimen that can be changed in the algorithm defining the drug administration regimen are the drug delivery volume and the drug delivery rate.

[0171] Therefore, in Fig.11A In an embodiment of the invention, the automatic injector 100 is configured to utilize a first drug dosing regimen when delivering the drug to the patient, and to determine a second drug dosing regimen based on the dosing data from the computer system 800 and the sensor data from the at least one patient monitoring sensor 91, the sensor data including data related to the density and / or thickness of the patient's tissue. The tissue density can affect the pain experienced by the patient during the injection. Therefore, when the density of the tissue is detected to be greater, a slower injection delivery rate can be used to reduce the pain of the injection. For example, the tissue density may be greater due to scar formation or because the tissue is muscle tissue rather than subcutaneous tissue.

[0172] Fig. 11B A schematic diagram of an example of a drug delivery speed (also referred to herein as a "drug delivery rate") and tissue density data obtained by at least one patient monitoring sensor 91 is shown. A first dosing regimen may depend on the dosing data. The dosing data may not be based on a specific patient or a specific injection site of a patient, but rather on an injection into a tissue having a predetermined density, the predetermined density corresponding to the density of scar-free tissue. If at least one patient monitoring sensor 91 obtains data indicating that the density of the patient's tissue is higher than a predetermined density, the automatic injector 100 may be configured to determine a second dosing regimen that specifies a lower drug delivery rate than the drug delivery rate of the first dosing regimen. In this way, the second drug dosing regimen may improve the patient's comfort during drug delivery.

[0173] Fig. 12A is a computer system 800 ( Figure 8 and Fig. 9 )、Drug administration device 500( Figure 5B , Figure 7 and Fig. 9 ) and at least one sensor 93 ( Fig. 9 ) is a schematic diagram of an exemplary embodiment of a drug administration system, which in this embodiment includes an automatic injector 100 ( Figure 1 ), the at least one sensor in the illustrated embodiment comprises at least one device sensor 92 ( Figure 5B ), the at least one device sensor being configured to obtain sensor data related to the temperature of at least the drug contained in the automatic injector 100. The drug administration system is generally similar to the above-described Fig. 9 The drug administration system is configured and used as discussed above. The first drug administration regimen and the second drug administration regimen of this embodiment specify at least the drug delivery volume and the drug delivery rate. Therefore, Fig. 12AThe autoinjector 100 of the embodiment of the invention is configured to utilize a first medication dosing regimen when delivering the medication to the patient and to determine a second medication dosing regimen based on the dosing data from the computer system 800 and the sensor data from the at least one device sensor 92. If the medication has been refrigerated and the medication does not have sufficient time to warm to room temperature prior to injection, then slowly injecting the medication will improve patient comfort.

[0174] Fig. 12B shows the drug delivery rate and the Fig. 12A Schematic diagram of an example of temperature data obtained by at least one device sensor 92 of an embodiment of the present invention. The automatic injector 100 is configured to determine a first dosing regimen based on dosing data transmitted from the computer system 800, wherein the dosing data is based on injection of a drug at a predetermined temperature. However, if the at least one device sensor 92 obtains data indicating that the drug is at a temperature lower than the predetermined temperature, the automatic injector 100 is configured to determine a second dosing regimen that specifies a lower drug delivery rate than the drug delivery rate of the first dosing regimen to improve patient comfort.

[0175] In addition, the autoinjector 100 is configured to: if at least one device sensor 92 detects that the temperature of the drug is above a predetermined high threshold value ( Fig. 12B ) and / or below a predetermined low threshold ( Fig. 12B If the "cold thresholds" in the embodiment are considered to be painful and / or dangerous to the patient, the operating device operates the prevention mechanism 40 ( Figure 5B ) (eg, allocation mechanism protection mechanism 140 ( Figure 1 )) to prevent the automatic injector 100 from being operated before delivering the drug according to either of the first dosing regimen and the second dosing regimen. Examples of such thresholds are an upper temperature limit of 55 degrees Celsius (predetermined high threshold) and a lower temperature limit of 2 degrees Celsius (predetermined low threshold).

[0176] Fig.13A is a computer system 800 ( Figure 8 and Fig. 9 )、Drug administration device 500( Figure 5B , Figure 7 and Fig. 9 ) and at least one device sensor 92 ( Figure 5B ) is a schematic diagram of another exemplary embodiment of a drug administration system, the drug administration device in this embodiment comprising an automatic injector 100 ( Figure 1 ), the at least one device sensor is configured in the illustrated embodiment to obtain sensor data related to the temperature of the drug contained in the automatic injector 100. The drug administration system is generally similar to the above-mentioned Fig. 9 The first drug administration scheme and the second drug administration scheme of the embodiment at least specify the drug delivery volume and the needle advancement depth of the automatic syringe needle (e.g., the discharge nozzle 122) during the drug delivery to the patient. Therefore, Fig.13A The automatic injector 100 of the embodiment is configured to utilize a first drug dosing regimen when delivering the drug to the patient, and to determine a second drug dosing regimen based on the dosing data from the computer system 800 and the sensor data from the at least one device sensor 92. The dosing data on which the first drug dosing regimen depends is based on delivering the drug at a predetermined temperature. If it is sensed that the temperature of the drug contained in the automatic injector 100 is lower than the predetermined temperature and the viscosity is large, advancing the needle into the patient's body with a smaller needle advancement depth will help ensure the patient's comfort. Therefore, in this embodiment, if the sensor data related to the temperature of the drug indicates that the temperature is lower than the temperature used to determine the first drug dosing regimen, the drug administration device 100 is configured to specify a needle insertion depth shorter than the needle insertion depth specified in the first dosing regimen in the drug dosing regimen (e.g., in an algorithm that defines the drug dosing regimen).

[0177] Fig. 13B Shown in Fig. 12A and Fig.13A Schematic diagram of an embodiment of sensor data obtained in an embodiment of the present invention, wherein the sensor data in the diagram shown represents the viscosity of the drug contained in the automatic injector 100. Fig. 12A and 13A In combination with embodiments of the present invention, the drug dosing regimen specifies the drug delivery rate ( Fig. 12A implementation scheme) and needle advancement depth ( Fig.13A ) and causes the drug administration device 500 (automatic injector 100) to be configured to determine a second drug dosing regimen that specifies both a drug delivery rate and a needle penetration depth.

[0178] In another example, the drug administration device 500 (autoinjector 100) and at least one device sensor 92 may include an orientation sensor. Thus, if the orientation sensor indicates that the drug administration device 500 is positioned such that the drug delivery rate may be reduced, for example, if the device 500 is inverted, the drug administration device 500 may be configured to determine a second drug administration regimen that takes into account this possible reduced delivery rate (e.g., by increasing the rate at which drug delivery occurs to take into account the sensed orientation indicating a reduced drug delivery rate).

[0179] Fig.14 The computer system 800 ( Figure 8 and Fig. 9) and a drug administration device 500, the computer system being a smart phone in this illustrated embodiment, the drug administration device including a communication interface 99 configured to communicate with a communication interface 899 of the computer system 800. The drug administration system is generally similar to that described above with respect to Fig. 9 The computer system 800 includes at least one user interface 80 configured to obtain user input data and transmit the user input data to the drug administration device 500. The drug administration device 500 is configured to: utilize a first drug administration regimen when delivering the drug from the drug administration device 500 to the patient, determine a second drug administration regimen for delivering the drug to the patient, the second drug administration regimen being dependent on the administration data from the computer system 800 and the user input data from the at least one user interface 80, the user input data being obtained by the user interface 80 during and / or after delivering the drug according to the first drug administration regimen; and utilize the second drug administration regimen when delivering the drug to the patient at some point after delivery according to the first administration regimen and determination of the second drug administration regimen.

[0180] The user input data may be related to factors that affect the patient's response to the first drug administration regimen and / or the patient's perceived response to the first drug administration regimen. In this way, even if the sensor cannot be used to obtain the patient's response and / or perceived response to drug delivery, the system can also better optimize the current drug administration regimen by taking the patient's response and / or perceived response to drug delivery into account. For example, a patient who plans to eat a lot can input user data into the user interface 80 because eating is a factor that may affect the patient's response to the first drug administration regimen. The computer system 800 is configured to send the user input data to the drug administration device 500. The device 500 is configured to use the user input data immediately before the patient eats a lot to determine a second drug administration regimen for administering a drug (e.g., rapid-acting insulin), and thereby formulate a second drug administration regimen that takes into account the input factors. In another example, if a patient feels discomfort when drug administration device 500 delivers drug according to a first drug administration regimen, the user may use user interface 80 to input such feedback of their perceived response to the first drug administration regimen, computer system 800 may send the user input data to drug administration device 500, and the drug administration device may then determine a second drug administration regimen dependent on the user input data by, for example, reducing the drug delivery rate, discharge nozzle advancement depth, discharge nozzle velocity, and / or discharge nozzle acceleration. Thus, the second drug administration regimen may be adjusted to improve the patient's perceived response to drug delivery.

[0181] Fig.15A schematic diagram of an exemplary embodiment of a drug administration system is shown, the drug administration system comprising: a computer system 800 ( Figure 8 and Fig. 9 ), a first drug administration device 300a and a second drug administration device 300b, each configured to communicate with the computer system 800, at least one sensor 94a, 98a configured to obtain sensor data and transmit the sensor data to the first drug administration device 300a, and at least one sensor 94b, 98b configured to obtain supplemental sensor data and transmit the supplemental sensor data to the second drug administration device 300b. The drug administration system is generally similar to the above-mentioned Fig. 9 The drug delivery system is configured and used as described, unless Fig.15 The drug administration system includes multiple drug administration devices 300a, 300b instead of one drug administration device. Fig.15 The drug administration system of FIG. 1 includes two drug administration devices 300a, 300b, but the drug administration system may include any number of drug administration devices and may be similar to Fig.15 The system is configured and used in other ways.

[0182] The second drug administration device 300b is configured to transmit the supplemental sensor data obtained by the at least one sensor 94b, 98b to the computer system 800 (e.g., using the communication interface 99b of the second drug administration device 300b and the communication interface 899 of the computer system 800), and the computer system 800 is configured to transmit the supplemental sensor data received from the second drug administration device 300b to the first drug administration device 300a (e.g., using the communication interface 99a of the first drug administration device 300a and the communication interface 899 of the computer system 800). The first drug administration device 300a is configured to utilize the supplemental sensor data received from the computer system 800 as part of its determination of the second drug administration regimen. Alternatively, the computer system 800 may be configured to utilize the supplemental sensor data received from the second drug administration device 300b to calculate the adjustment required for the second drug administration regimen for delivering the drug contained in the first drug administration device 300a to the patient. The adjustment may then be transmitted from the computer system 800 to the first drug administration device 300a.

[0183] The use of the second drug administration device 300b (and any additional drug administration devices) in the drug administration system enables the first drug administration device 300a (or the computer system 800 in an embodiment in which the computer system 800 determines a second drug administration regimen and sends it to the first drug administration device 300a) to determine the second drug administration regimen for delivering the drug contained in the first drug administration device 300a to the patient based not only on the drug administration data from the computer system 800 and / or the sensory data from at least one of its sensors 94a, 98a, but also on supplemental sensor data associated with the second drug administration device 300b.

[0184] The second drug administration device 300b may be a drug administration device used by the same patient as the first drug administration device 300a but delivering a different drug than the first drug administration device 300a. Thus, in this manner, the first drug administration device 300a may be configured to receive supplemental sensor data from the computer system 800 indicating that the second drug administration device 300b has been used to deliver a certain drug to the patient after the drug has been delivered from the first drug administration device 300a according to a first drug administration regimen for delivering the drug contained in the first drug administration device 300a to the patient. The first drug administration device 300a (or the computer system 800 in an embodiment in which the computer system 800 determines the second administration regimen and sends it to the first drug administration device 300a) may be configured to subsequently determine that the second drug administration regimen should deliver the drug at a set time after the second drug administration device 300b is used to deliver the other drug to the patient to avoid interference between the drug of the first drug administration device 300a and the drug of the second drug administration device 300b. Alternatively, the first drug administration device 300a (or the computer system 800 in an embodiment in which the computer system 800 determines the second dosing regimen and sends it to the first drug administration device 300a) can be configured to determine that the second drug dosing regimen should deliver the drug to the patient at the same time or shortly after the second drug administration device 300b delivers its drug to the patient, because the two drugs have a beneficial effect when delivered together. If the drug administration system includes one or more additional drug administration devices, each of these additional drug administration devices can also be used by the patient and, similar to the second drug administration device 300b, can be used for the second dosing regimen of the first drug administration. This can further help optimize the second drug dosing regimen for the patient who is using the first drug administration device 300a.

[0185] The second drug administration device 300b may alternatively be a drug administration device used by another patient (e.g., a different patient than the patient using the first drug administration device 300a), such that the first drug administration device 300a may be configured to receive supplemental sensor data related to drug administration to the other patient and the other patient's response to other drug administration regimens used by the second drug administration device 300b, and use the supplemental sensor data to determine a second drug administration regimen optimized for the patient using the first drug administration device 300a (or the computer system 800 in an embodiment where the computer system 800 determines the second administration regimen and sends it to the first drug administration device 300a). In this way, the first drug administration device 300a may be configured to implement a drug administration regimen adjusted to benefit from the experience of the other patient. This may speed up the optimization process of the drug administration regimen. If the drug administration system includes one or more additional drug administration devices, each of these additional drug administration devices may also be used by a different patient than the patient using the first drug administration device 300a, and similar to the second drug administration device 300b, may be used for a second administration regimen of the first drug administration. This may further help optimize the current drug dosing regimen for the patient who is using the first drug administration device 300a.

[0186] In the illustrated embodiment, at least one sensor associated with the first drug administration device 300a includes a position sensor 98 ( Figure 5B ) is configured to obtain sensor data related to the geographic location of the drug administration device 300a, which in the illustrated embodiment is an inhaler (e.g., Figure 3 In the illustrated embodiment, the at least one sensor associated with the first drug administration device 300a also includes a position sensor 94 ( Figure 5B ) is configured to obtain data related to the environment in which the drug administration device 300a is located, which data in this illustrated embodiment includes the pollen level of the environment in which the first drug administration device 300a is present. In this illustrated embodiment, at least one sensor associated with the second drug administration device 300b similarly includes a configuration and use similar to the position sensor 98 ( Figure 5B ) of the position sensor 98b, including a configuration and use similar to the position sensor 94 ( Figure 5B ) and, in the illustrated embodiment, includes a second drug administration device 300b that is an inhaler (e.g., Figure 3 As will be appreciated by those skilled in the art, pollen levels (eg, pollen counts) may be particularly important for patients using an inhaler.

[0187] Thus, in this illustrated embodiment, the second medication dosing regimen of the first medication administration device 300a is configured to be determined as a function of the dosing data from the computer system 800, the sensor data regarding the location of the first inhaler 300a, the sensor data regarding the pollen level of the environment in which the first inhaler 300a is present, the sensor data regarding the location of the second inhaler 300b, and the sensor data regarding the pollen level of the environment in which the second inhaler 300b is present. Thus, for example, if the sensor data indicates that the first inhaler 300a is moving toward a location proximate to the location of the second inhaler 300b, and the pollen count at the location of the second inhaler 300b is higher than the pollen count at the location of the first inhaler 300a, the first inhaler 300a may be configured to determine a second medication dosing regimen having a higher dose than the dose of the first medication dosing regimen to preemptively counter the higher pollen levels that the patient associated with the first medication administration device 300a may experience and thereby improve patient comfort and outcomes.

[0188] In other embodiments, the at least one sensor associated with each of the first drug administration device 300a and the second drug administration device 300b may include additional or alternative sensors, such as one or more of the following sensors: a patient monitoring sensor configured to obtain supplemental sensor data related to the patient's condition; a device sensor configured to obtain supplemental sensor data related to the drug administration device; an environmental sensor configured to obtain supplemental sensor data related to the environment in which the drug administration device is present (in addition to the pollen level already described by the first environmental sensor 94a for the first drug administration device 300a and the second environmental sensor 94b for the second drug administration device 300b); and a location sensor configured to obtain supplemental sensor data related to the geographic location of the drug administration device. The patient monitoring sensor, device sensor, environmental sensor, and location sensor may each have any of the features discussed herein with respect to similarly named sensors.

[0189] The second drug administration device 300b may include a user interface configured to obtain supplemental user input data (e.g., the user interface discussed above). Figure 5BThe second drug administration device 300b may be configured to transmit the supplemental user input data to the computer system 800, for example, via a second communication interface 99b that communicates with the computer system's communication interface 899, which may then send the supplemental user input data to the first drug administration device 300a, or use the supplemental user input data to determine a second drug administration regimen and send the determined second drug administration regimen to the first drug administration device 300a. The user interface of the second drug administration device 300b may be in addition to or in place of at least one sensor 94b, 98b configured to obtain supplemental sensor data as described herein. The second drug administration device 300b is configured to receive and transmit user input so that the drug administration system, when determining the second drug administration regimen, can determine the second drug administration regimen based on the user input data associated with the second drug administration device 300b. As discussed herein, the user input data may be related to factors that affect the patient's response and / or perceived response to the drug administration regimen.

[0190] exist Fig.15 In the illustrated embodiment, each of the first drug administration device 300a and the second drug administration device 300b includes an inhaler (e.g., Figure 3 However, any one or both of the drug administration devices 300a, 300b (and any other drug administration devices included in the drug administration system) may also adopt other types of drug administration devices as described herein, and the drug administration system is similar to Fig.15 The drug administration system of the present invention may be configured and used in other ways. For example, each of the first drug administration device and the second drug administration device may include an infusion pump (e.g., Figure 2 In one embodiment, the infusion pump 200 is configured to deliver insulin to a patient and the second infusion pump is configured to deliver glucagon to the same patient. Each infusion pump may include a patient sensor configured to obtain sensor data related to the blood glucose level of the patient associated therewith. Thus, the first infusion pump may be configured to determine a second medication dosing regimen based at least in part on supplemental sensor data obtained by the patient sensor of the second infusion pump to maintain a stable level of glucose in the blood.

[0191] Fig.15The drug administration system of the present invention may also include at least one external sensor that is not associated with any of the first drug administration device 300a and the second drug administration device 300b, and the at least one external sensor is configured to collect external sensor data and transmit the external sensor data to the computer system 800. The second drug administration regimen of the first drug administration device 300b may further depend on the external sensor data received from the computer system 800. Taking the external sensor data into account allows the first drug administration device 300a (or the computer system 800 in the embodiment in which the computer system 800 determines the second administration regimen and sends it to the first drug administration device 300a) to determine the second administration regimen based on additional data. Therefore, more data can be used to determine the second drug administration regimen, and thus the second drug administration regimen can be better optimized and the patient's results can be improved. The at least one external sensor may include any of various types of sensors. For example, the at least one external sensor may include an environmental sensor that detects the air quality of a particular location and transmits the sensor data to the computer system 800.

[0192] As described above, at least one sensor configured to sense data that can be used to determine a medication dosing regimen can be part of a medication administration device. Fig.11A One embodiment of such a device, namely an autoinjector 100 including at least one patient monitoring sensor 91 , is shown. Fig.16A and Fig. 16B Such a device (ie, an automatic injector 900 including the at least one patient monitoring sensor 991 (eg, Figure 1 100)). In the illustrated embodiment, at least one patient monitoring sensor 991 includes a temperature sensor configured to measure the body temperature of the patient 902. In the illustrated embodiment, the temperature sensor 991 is a temporal scanner configured to be placed against the forehead to measure the body temperature, such as Fig.16A As shown in , the temperature sensor 991 is placed on the forehead of the patient 902. However, the temperature sensor 991 may adopt other types of temperature sensors.

[0193] The autoinjector 900 also includes a user interface 980 in the form of a display configured to display information thereon to a user. Fig. 16B The user interface 980 in the example of shows the patient's measured temperature as 98.6 degrees F. As will be appreciated by those skilled in the art, the user interface 980 may be part of the time scanner 991 .

[0194] If the patient's body temperature is higher than normal, for example, higher than 98.6 degrees Fahrenheit, the effectiveness of some drugs may be affected. The patient's body temperature measured by the temperature sensor 991 can be used by the computer system 800 to determine the drug dosing regimen for using the automatic injector 900 to deliver the drug to the patient 902. The drug dosing regimen can be a first drug dosing regimen, a second drug dosing regimen, or a drug dosing regimen after the second drug dosing regimen. As described above, the computer system 800 may be included in the automatic injector 900, or may be located outside the automatic injector 900 and communicate electronically with it. The user of the automatic injector 900 may be instructed to measure the patient's temperature before delivering the drug from the automatic injector 900 to help ensure that the computer system 800 adjusts the drug dosing regimen (if necessary) based on the sensed patient's body temperature before the drug is delivered. The user may be instructed in a variety of ways, such as by a medical care professional in a verbal manner, in the instructions for use (IFU) of the automatic injector, on a printed prescription label on the automatic injector package, via any of the user interface 980 (and / or other user interfaces of the automatic injector 900), etc.

[0195] In an exemplary embodiment, the auto-injector 900 is configured to operate a device operation prevention mechanism (e.g., Figure 1 The device operation prevention mechanism 140 of the auto-injector 900 is configured to allow operation of the auto-injector 900 according to the medication administration regimen when the temperature sensor 991 detects that the temperature of the patient 902 is below a predetermined high threshold, wherein the predetermined high threshold corresponds to a temperature at which the effectiveness of the medication may be adversely affected if the medication is delivered to the patient 902 having the temperature at or above that temperature. An example of a predetermined high threshold is a normal body temperature of 98.6 degrees Fahrenheit. The auto-injector 900 is also configured to operate the device operation prevention mechanism (e.g., Figure 1The device operation prevention mechanism 140 is provided to prevent the operation of the automatic injector 900 before the drug is delivered according to the drug dosing regimen when the temperature sensor 991 detects that the temperature of the patient 902 is equal to or higher than a predetermined high threshold. The user interface 980 (or other user interfaces of the automatic injector 900) can be configured to provide a user with a notification that the automatic injector 900 is temporarily disabled due to the patient's current body temperature. After each time the patient's temperature is measured by the temperature sensor 991 to be equal to or higher than the predetermined high threshold, the user can be instructed to measure the patient's temperature again to allow the automatic injector 900 to be enabled for operation once the patient's temperature is measured to be lower than the predetermined high threshold. The user can be so instructed in a variety of ways, such as in the IFU of the automatic injector, on the printed prescription label on the packaging of the automatic injector, via the user interface 980 (and / or other user interfaces of the automatic injector 900), etc. The user can be instructed to wait a certain amount of time before re-measuring the patient's temperature.

[0196] As will be appreciated by those skilled in the art, the patient's body temperature may be a biometric indicator that is important for understanding the long-term effects of a drug on a patient. Thus, the patient's body temperature measured by the temperature sensor 991 just prior to drug delivery may be used to assess the long-term effects of a drug delivered to a patient 902 using the auto-injector 900. Thus, in some embodiments, the patient's temperature sensed by the temperature sensor 991 may be used by the computer system 800 and / or a healthcare professional to determine a drug dosing regimen, and to assess the long-term effects of a drug by associating the patient's measured body temperature with each delivery of the drug from the auto-injector 900 and any other auto-injectors 900 to the patient. In some embodiments, the patient's temperature sensed by the temperature sensor 991 may not be used at all to determine a drug dosing regimen, but may be used by the computer system 800 and / or a healthcare professional to assess the long-term effects of a drug by associating the patient's measured body temperature with each delivery of the drug from the auto-injector 900 and any other auto-injectors 900 to the patient.

[0197] All devices and systems disclosed herein can be designed to be discarded after a single use, or can be designed for multiple uses. However, in either case, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of disassembling the device, cleaning or replacing specific parts, and subsequent reassembly steps. Specifically, the device is removable, and any number of specific parts or components of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing specific components, the device can be reassembled for subsequent use at a repair facility or by a surgical team just before a surgical operation. Those skilled in the art will appreciate that the reconditioning device can be disassembled, cleaned / replaced, and reassembled using a variety of techniques. The use of such techniques and the resulting repair device are within the scope of this application.

[0198] It may be preferred that the devices disclosed herein be sterilized prior to use. This can be accomplished by any number of means known to those skilled in the art, including beta or gamma radiation, ethylene oxide, steam, and liquid baths (e.g., cold soaks). Exemplary embodiments of sterilizing devices including internal circuitry are described in more detail in U.S. Patent Publication No. 2009 / 0202387, published on August 13, 2009 and entitled "System And Method Of Sterilizing An Implantable Medical Device." It is preferred that the device be hermetically sealed if implanted. This can be accomplished by any number of means known to those skilled in the art.

[0199] The present disclosure has been described above by way of example only in the context of the overall disclosure provided herein. It should be understood that modifications may be made within the spirit and scope of the claims without departing from the overall scope of the present disclosure.

Claims

1. A drug administration system, comprising: a drug administration device, wherein the drug administration device comprises a communication interface configured to communicate with a communication interface of a computer system; at least one sensor configured to obtain sensor data and to transmit the sensor data to the drug administration device; and wherein: The drug administration device is configured to: utilizing a first drug dosing regimen when the drug is delivered from the drug administration device to the patient; determining a second drug dosing regimen for delivering the drug from the drug administration device to the patient, the second drug dosing regimen being dependent on: administration data from the computer system used as a basis for determining the first medication administration regimen; and the sensor data from the at least one sensor, the sensor data obtained by the at least one sensor during and / or after delivery of the drug according to the first drug dosing regimen; and utilizing the second drug dosing regimen when the drug is delivered from the drug administration device to the patient; wherein the drug administration device is configured to prevent the drug administration device from being operated prior to delivering the drug according to the first drug administration regimen or the second drug administration regimen if the temperature of the drug detected by the sensor is above a predetermined high threshold or below a predetermined low threshold; and wherein the drug administration device is configured to allow the drug administration device to be operated according to the first drug administration regimen or the second drug administration regimen if the temperature of the patient detected by the sensor is below a predetermined high threshold and to prevent the drug administration device from being operated before delivering the drug according to the first drug administration regimen or the second drug administration regimen if the temperature of the patient detected by the sensor is equal to or above the predetermined high threshold and to allow the drug administration device to be enabled for operation once the temperature of the patient is detected to be below the predetermined high threshold.

2. The drug administration system according to claim 1, wherein: The drug administration device is configured to determine the first drug administration regimen for delivering the drug to the patient prior to utilizing the first drug administration regimen when the drug is delivered from the drug administration device to the patient.

3. The drug administration system according to any one of claims 1 to 2, wherein: Each of the first medication dosing regimen and the second medication dosing regimen each specifies one or more of the following medication dosing parameters: drug delivery rate; medication delivery time and / or date; drug delivery volume; and Duration of drug delivery.

4. The drug administration system according to any one of claims 1 to 2, wherein: The at least one sensor includes one or more of the following: a patient monitoring sensor configured to obtain sensor data related to a condition of the patient; a device sensor configured to obtain sensor data related to the drug administration device; an environmental sensor configured to obtain sensor data related to an environment in which the drug administration device is present; and A position sensor is configured to obtain sensor data related to a geographic location of the drug administration device.

5. The drug administration system according to any one of claims 1 to 2, further comprising: at least one external sensor configured to obtain external sensor data and to transmit the external sensor data to the computer system; And among them The second medication dosing regimen is further determined based on external sensor data from the computer system.

6. The drug administration system according to any one of claims 1 to 2, further comprising: a second drug administration device, wherein the second drug administration device comprises a communication interface configured to communicate with the communication interface of the computer system; at least one sensor configured to obtain supplemental sensor data and to transmit the supplemental sensor data to the second drug administration device; and in The second medication dosing regimen is further determined based on the supplemental sensor data from the computer system.

7. The drug administration system according to any one of claims 1 to 2, further comprising: a second drug administration device, wherein the second drug administration device comprises a communication interface configured to communicate with the communication interface of the computer system; and at least one user interface configured to obtain supplemental user input data and to communicate the supplemental user input data to the second drug administration device; And among them The second medication dosing regimen is further determined depending upon the supplemental user input data from the computer system.

8. The drug administration system of claim 7, further comprising at least one sensor configured to obtain supplemental sensor data and to transmit the supplemental sensor data to the second drug administration device; and Wherein said second medication administration regimen is further determined depending upon said supplemental sensor data from said computer system.

9. The drug administration system according to claim 6, wherein: The at least one sensor configured to obtain supplemental sensor data includes one or more of: a patient monitoring sensor configured to obtain supplemental sensor data related to a condition of the patient; a device sensor configured to obtain supplemental sensor data related to the second drug administration device; an environmental sensor configured to obtain supplemental sensor data related to an environment in which the second drug administration device is present; and A location sensor is configured to obtain supplemental sensor data related to a geographic location of the second drug administration device.

10. The drug administration system according to any one of claims 1 to 2, wherein: The drug administration device is an autoinjector; and wherein The first drug dosing regimen and the second drug dosing regimen each specify one or more of the following dosing parameters: a discharge nozzle advancement depth of a discharge nozzle during delivery of said medicament to said patient; a discharge nozzle velocity of the discharge nozzle during delivery of the drug to the patient; and A discharge nozzle acceleration of the discharge nozzle during delivery of the drug to the patient.

11. The drug administration system according to any one of claims 1 to 2, wherein: The drug administration device is an inhaler.

12. The drug administration system according to any one of claims 1 to 2, wherein: The drug administration device is an infusion pump.

13. The drug administration system according to claim 2, wherein: The first medication dosing regimen is determined based on the dosing data transmitted from the computer system.

14. The drug administration system according to any one of claims 1 to 2 and 13, wherein: The first medication dosing regimen and the second medication dosing regimen specify one or more of the following medication dosing parameters: drug delivery rate; drug delivery volume; and duration of drug delivery; And among them, The values ​​of one or more of the parameters in the first medication dosing regimen are different from the values ​​of corresponding parameters in the second medication dosing regimen.

15. The drug administration system according to any one of claims 1 to 2, wherein: The drug includes at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

16. A drug administration system, comprising: a drug administration device, wherein the drug administration device comprises a communication interface configured to communicate with a communication interface of a computer system; at least one sensor configured to obtain sensor data and to transmit the sensor data to the drug administration device; at least one user interface configured to obtain user input data and to communicate the user input data to the drug administration device; and wherein: the drug administration device is configured to: utilizing a first drug dosing regimen when the drug is delivered from the drug administration device to the patient; determining a second drug dosing regimen for delivering the drug from the drug administration device to the patient, the second drug dosing regimen being dependent on: administration data from the computer system used as a basis for determining the first medication administration regimen; and the user input data from the at least one user interface, the user input data being obtained by the user interface during and / or after delivery of the drug from the drug administration device according to the first drug dosing regimen; and utilizing the second drug dosing regimen when the drug is delivered from the drug administration device to the patient; wherein the drug administration device is configured to prevent the drug administration device from being operated prior to delivering the drug according to the first drug administration regimen or the second drug administration regimen if the temperature of the drug detected by the sensor is above a predetermined high threshold or below a predetermined low threshold; and wherein the drug administration device is configured to allow the drug administration device to be operated according to the first drug administration regimen or the second drug administration regimen if the temperature of the patient detected by the sensor is below a predetermined high threshold and to prevent the drug administration device from being operated before delivering the drug according to the first drug administration regimen or the second drug administration regimen if the temperature of the patient detected by the sensor is equal to or above the predetermined high threshold and to allow the drug administration device to be enabled for operation once the temperature of the patient is detected to be below the predetermined high threshold.

17. The drug administration system according to claim 16, wherein: The drug administration device is configured to determine the first drug administration regimen for delivering the drug from the drug administration device to the patient prior to utilizing the first drug administration regimen while the drug is being delivered from the drug administration device to the patient.

18. The drug administration system according to claim 16 or 17, wherein: The drug administration device is configured to determine the second drug administration regimen further dependent on the sensor data from the at least one sensor, the sensor data being obtained by the at least one sensor during and / or after delivery of the drug from the drug administration device according to the first drug administration regimen.

19. The drug administration system according to any one of claims 16 to 17, wherein: Each of the first medication dosing regimen and the second medication dosing regimen each specifies one or more of the following medication dosing parameters: drug delivery rate; medication delivery time and / or date; drug delivery volume; and Duration of drug delivery.

20. The drug administration system of claim 18, wherein: The at least one sensor includes one or more of the following: a patient monitoring sensor configured to obtain sensor data related to a condition of the patient; a device sensor configured to obtain sensor data related to the drug administration device; an environmental sensor configured to obtain sensor data related to an environment in which the drug administration device is present; and A position sensor is configured to obtain sensor data related to a geographic location of the drug administration device.

21. The drug administration system according to any one of claims 16 to 17, further comprising: at least one external sensor configured to obtain external sensor data and to transmit the external sensor data to the computer system; And among them The second medication dosing regimen is further determined based on external sensor data from the computer system.

22. The drug administration system according to any one of claims 16 to 17, further comprising: a second drug administration device, wherein the second drug administration device comprises a communication interface configured to communicate with the communication interface of the computer system; at least one sensor configured to obtain supplemental sensor data and to transmit the supplemental sensor data to the second drug administration device; and in The second medication dosing regimen is further determined based on the supplemental sensor data from the computer system.

23. The drug administration system according to any one of claims 16 to 17, further comprising: a second drug administration device, wherein the second drug administration device comprises a communication interface configured to communicate with the communication interface of the computer system; and at least one user interface configured to obtain supplemental user input data and to communicate the supplemental user input data to the second drug administration device; And among them The second medication dosing regimen is further determined depending upon the supplemental user input data from the computer system.

24. The drug administration system of claim 23, further comprising at least one sensor configured to obtain supplemental sensor data and to transmit the supplemental sensor data to the second drug administration device; and Wherein said second medication administration regimen is further determined depending upon said supplemental sensor data from said computer system.

25. The drug administration system of claim 22, wherein: The at least one sensor configured to obtain supplemental sensor data includes one or more of: a patient monitoring sensor configured to obtain supplemental sensor data related to a condition of the patient; a device sensor configured to obtain supplemental sensor data related to the second drug administration device; an environmental sensor configured to obtain supplemental sensor data related to an environment in which the second drug administration device is present; and A location sensor is configured to obtain supplemental sensor data related to a geographic location of the second drug administration device.

26. The drug administration system according to any one of claims 16 to 17, wherein The drug administration device is an autoinjector; and wherein The first drug dosing regimen and the second drug dosing regimen each specify one or more of the following dosing parameters: a discharge nozzle advancement depth of a discharge nozzle during delivery of said medicament to said patient; a discharge nozzle velocity of the discharge nozzle during delivery of the drug to the patient; and A discharge nozzle acceleration of the discharge nozzle during delivery of the drug to the patient.

27. The drug administration system according to any one of claims 16 to 17, wherein: The drug administration device is an inhaler.

28. The drug administration system according to any one of claims 16 to 17, wherein The drug administration device is an infusion pump.

29. The drug administration system of claim 17, wherein: The first medication dosing regimen is determined based on the dosing data transmitted from the computer system.

30. The drug administration system according to any one of claims 16 to 17 and 29, wherein: The first medication dosing regimen and the second medication dosing regimen specify one or more of the following medication dosing parameters: drug delivery rate; drug delivery volume; and duration of drug delivery; And among them, The values ​​of one or more of the parameters in the first medication dosing regimen are different from the values ​​of corresponding parameters in the second medication dosing regimen.

31. The drug administration system according to any one of claims 16 to 17, wherein The drug includes at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

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