Drug administration device and system for establishing dosage regimen and compatibility of components

Abstract

To provide a method, system and device for establishing dosing parameters for a drug administration device and for establishing compatibility of components of the drug administration device.SOLUTION: The method includes obtaining data 1004 from the medication holder 1006 and communicating the data to the processor, communicating a relevant subset of the medication parameter data 1008 from the server to the processor 1002, establishing medication parameters for the medication delivery device based on the relevant subset of the medication parameter data determined based on the medication holder data, obtaining first component data associated with a first component of the medication delivery device, comparing the first component data to acceptable first component data, and setting an operational state of the medication delivery device based on said comparison.SELECTED DRAWING: Figure 10

Description

[Technical Field]

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

[0002] Pharmaceutical products (including large molecule and small molecule drugs, hereinafter referred to as "drugs") are used for specific medical indications. For treatment, drugs may be administered to patients in a variety of different ways. Regardless of the mode of administration, Care must be taken when administering drugs to avoid adverse effects. For example: Care must be taken to ensure that patients are not given more than is safe. This determines the amount of dose given and the time frame over which the dose is delivered, sometimes relative to a previous dose or other Furthermore, the use of the wrong drug or its age or Care must be taken to avoid inadvertently administering to patients drugs that have deteriorated due to storage conditions. All of these considerations are relevant to a particular drug or drug combination. However, this guidance may be subject to risk, e.g., human error. Any mistake that is not always followed correctly, which can lead to adverse effects on the patient or This can lead to inappropriate drug administration, e.g., inadequate medication for a particular medical indication. A minute or excess volume of drug is administered.

[0003] Additionally, different drugs may be available in a given drug delivery device or system. If the incorrect dosage regimen is used for the drug actually delivered to the patient, There is an increased risk.

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

[0005] The dosage form may be administered directly to a patient via a drug administration device. (e.g., autoinjectors, jet injectors, and infusion pumps), nasal sprays - Many different types of devices and inhalers are commonly available for the delivery of various dosage forms. There are many drug delivery devices.

[0006] The drug delivery device may be comprised of a variety of different components. Careless use of the wrong components can cause problems with device operation and drug administration. This may result in the prescription of inappropriate medication regimens that may be harmful to the patient's health. This may cause problems. Summary of the Invention [Means for solving the problem]

[0007] In one aspect, a method for establishing dosing parameters for a drug delivery device includes: In an embodiment, drug holder data is obtained from a drug holder of a drug administration device, and and communicating the holder data to a processor. Either the processor or the external device includes a processor. The method also includes transmitting at least a relevant subset of the medication parameter data from the server to the processor. and communicating to the drug administration device based on the relevant subset of medication parameter data. and establishing medication parameters for the medication. The dose is determined based on the medication holder data.

[0008] The method may vary in any number of ways. For example, the method may include processing medication holder data. and communicating the associated subset of medication parameter data from the processor to the server on the server. In at least some embodiments, the method may also include determining and communicating medication administration device data from the processor to the server, The relevant subset of data is based on both the medication holder data and the medication administration device data. The drug administration device data may be determined by identifying the drug administration device as being at least one It can be distinguished from other forms of drug delivery devices.

[0009] In another embodiment, the method further comprises using a processor after communication to generate the medication parameter data. and communicating the medication parameter data to the patient. and a non-associated subset of the medication parameter data. In at least some embodiments, the medication parameter data may include communicating the medication parameter data. The relevant subset of data is based on both the medication holder data and the medication administration device data. The drug administration device data may be determined by comparing the drug administration device with at least one other can be distinguished from drug administration devices in the form of

[0010] In yet another embodiment, the communication between the processor and the server may include encrypted communication. In yet another embodiment, the communication between the medication holder and the processor is encrypted communication. may include:

[0011] In another embodiment, the method further comprises storing the medication parameters in a memory of the drug administration device. In at least some embodiments, storing the dosing parameters in a memory This includes updating medication parameters stored in memory.

[0012] In yet another embodiment, the relevant subset of medication parameter data includes a plurality of medication parameters. Indicates which set of numbers to adopt.

[0013] In another embodiment, the drug is infliximab, golimumab, ustekinumab, daratumab Mab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and and paliperidone palmitate.

[0014] In yet another embodiment, the method is a method of operating a drug delivery device, comprising: Establishing dosage parameters for a drug delivery device and assessing suitability of the dosage parameters and preventing dispensing of the drug if the dosing parameters are not suitable. and if the parameters are suitable, dispensing the medication based on the dosing parameters. In at least some embodiments, the method may include assessing the suitability of dosing parameters. The step of comparing the medication parameters with acceptable medication parameters stored in a memory of the medication administration device includes: The method may include comparing the parameter.

[0015] In another embodiment, the method further comprises: providing authentication data associated with the medication parameter data to the authorization server; The authenticity of the medication parameter data is verified by comparing it with acceptable medication parameter authentication data. In yet another embodiment, the method may include evaluating the accuracy of the drug holder data. by comparing the associated authentication data with acceptable medication holder authentication data; In another embodiment, the medication parameters may be is the volume of drug dispensed, the frequency of drug dispense, the rate of drug dispense, and the time at which the drug is dispensed. In yet another embodiment, the medication holder data may include at least one of: the type of drug in the holder, the concentration of the drug in the drug holder, the origin of the drug in the drug holder, and In another embodiment, the medication holder may include at least one indication of the volume of medication in the medication holder. The method further comprises converting authentication data associated with the medication holder into acceptable medication holder authentication data.

[0013] A further alternative embodiment may include assessing the authenticity of the medication holder by comparing the medication holder with the authenticity of the medication holder. In an embodiment, the method further comprises: converting authentication data associated with the medication administration device into an acceptable medication Assessing the authenticity of a drug administration device by comparing it with administration device authentication data This may include:

[0016] In another aspect, a drug administration device is provided, in one embodiment, configured to hold a drug. a medication holder configured to store medication holder data; A drug administration device is provided that includes a data storage component. The drug administration device also includes a data storage component. a first communication interface configured to receive medication holder data from the data storage component; and configured to receive medication holder data from the first communication interface. and a processor configured to receive at least a relevant subset of the medication parameter data from the server. a second communication interface configured to receive the medication and to store the medication parameters; Based on the established memory and medication parameters established by the relevant subset of medications. and a dispensing mechanism configured to dispense the medication from the medication holder.

[0017] The drug administration device may differ in any number of ways. For example, the processor may and configured to determine a relevant subset of medication parameter data based on the data. In yet another embodiment, the memory is adapted to store multiple sets of medication parameters. and a relevant subset of the medication parameter data is configured to operate the dispensing mechanism. , which of multiple sets of medication parameters is to be employed. In another embodiment, the dosage parameters include the volume of drug dispensed, the frequency of drug dispense, the amount of drug dispensed, the dosage of the drug, and the amount of drug dispensed. The parameters may include at least one of the rate of delivery and the time over which the drug is delivered. In the example, the drug holder data may include the type of drug in the drug holder, the concentration of the drug in the drug holder, , the origin of the drug in the drug holder, and the volume of the drug in the drug holder. In yet another embodiment, the memory is configured to store authentication data. In another embodiment, the drug may be infliximab, golimumab, ustekinumab, dapagliflozin, Latumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine The compound may comprise at least one of paliperidone, phenanthrene ...

[0018] In another aspect, a drug delivery system is provided, in one embodiment, configured to hold a drug. a medication holder configured to dispense a medication from the medication holder; A drug delivery system is provided that includes a drug delivery device that includes a delivery mechanism. an external device configured to obtain medication holder data associated with the medication holder; The external device further includes a server for receiving at least a relevant subset of the medication parameter data from the server. a first communication interface configured to receive the set of medication holder data; a processor configured to receive the medication and a memory configured to store the medication parameters. The dispensing mechanism is established by an associated subset of medication parameter data. The device is configured to dispense the medication from the medication holder based on the determined medication parameters.

[0019] The drug delivery system can have any number of variations. For example, the drug holder can be The external device may include a data storage component configured to store data, The object holder may include a second communication interface configured to receive object holder data. In this embodiment, the external device includes an image sensor configured to acquire medication holder data. In yet another embodiment, the processor may include a processor for determining whether or not a medication is to be administered based on the medication holder data. In yet another embodiment, the method may be configured to determine a relevant subset of the parameter data. Alternatively, the memory may be configured to store a plurality of sets of medication parameters, The relevant subset of data may be used to determine a plurality of medication parameters to operate the dispensing mechanism. In another embodiment, the medication pattern may indicate which of the medication patterns is to be used. The parameters include the volume of drug dispensed, the frequency of drug dispense, the rate of drug dispense, and the time at which the drug is dispensed. In yet another embodiment, the medication holder data may include at least one of the following: The type of drug in the drug holder, the concentration of the drug in the drug holder, the origin of the drug in the drug holder The device may include an indication of at least one of the source, the volume of the drug in the drug holder, and the volume of the drug in the drug holder. In an embodiment, the memory may be configured to store authentication data. The drugs were infliximab, golimumab, ustekinumab, daratumumab, and guselkumab. , epoetin alfa, risperidone, esketamine, ketamine, and pars palmitate The compound may comprise at least one of peridones.

[0020] In another embodiment, the drug administration system includes a drug administration device, The housing is configured to hold the drug and at least partially a medication holder within the syringe, and a syringe configured to dispense medication and having at least one The system also includes a dispensing mechanism partially within the housing. configured to obtain first component data associated with the component of the first component, receiving the component data and comparing it to the acceptable first component data, and based on the comparison: an external device including a processor configured to set an operational state of the medication administration device; Includes s.

[0021] The system may have any number of variations. For example, the external device may also be used to administer medication. The device may include an image sensor configured to image the device, and the first component data may include an image sensor configured to image the device. In another embodiment, the drug administration device may also include first component data. The device may include a data storage device configured to accommodate the

[0022] In yet another embodiment, the data storage device may be attached to the medication holder. In an embodiment, the first component data may include the type of medication in the medication holder, the origin of the medication, the medication The least of the following: the concentration of the drug in the holder, the expiration date of the drug, and the volume of the drug in the drug holder Each may contain one index.

[0023] In another embodiment, the data storage device may be associated with the housing or the drug dispensing mechanism. In at least some embodiments, the first component data is a function of the drug delivery mechanism. The first component data may include an index of compatible medication holder parameters. It may include.

[0024] In another embodiment, the medication holder may be removable from the medication administration device. In yet another embodiment, the drug is infliximab, golimumab, ustekinumab, daratumab Mumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0025] In another aspect, a method for establishing compatibility of components of a drug delivery device, comprising: In one embodiment, first component data relating to a first component of a drug administration device is acquired. obtaining the first component data and comparing the first component data to acceptable first component data; and determining whether the drug is a medicament based on a comparison of the first component data with the acceptable first component data. and setting an operational state of the substance dispensing device.

[0026] The method may vary in any number of ways. For example, obtaining the first component data may include communicating first component data from the first component to an external device. In at least some embodiments, the first component data is converted into an acceptable first configuration. The comparing with the component data may occur on the external device. The first component data may include image data, and acquiring the first component data may include using an external device to The method may include imaging the substance administration device.

[0027] In another embodiment, obtaining the first component data may occur on an external device. In at least some embodiments, the first component data is converted into an acceptable first configuration. The comparing with the component data may occur on the external device. The first component data may include image data, and acquiring the first component data may include using an external device to The method may include imaging the substance administration device.

[0028] In yet another embodiment, the first component data is compared to acceptable first component data. The comparing may utilize a processor of the medication administration device. In one embodiment, the first component may include a processor. The comparison with the available first component data may utilize a processor.

[0029] In yet another embodiment, obtaining the first component data comprises: The method may include communicating the data from the first component to a processor of the medication administration device. In at least some embodiments, the first component may include a processor. Comparing the element data to the acceptable first component data utilizes a processor. obtain.

[0030] In another embodiment, setting the operational state of the medication delivery device comprises setting the first component data If the data corresponds to the acceptable first component data, the operational state should be at full capacity. flagging the first component data as acceptable and flagging the first component data as acceptable If the data is not available, the operational state is flagged as not being at full capacity. or if all necessary flags indicate that the operational state should be full. If so, set the operational state as fully operational and any required flags If the operating state indicates that it should not be at full capacity, or setting it as an unreadable value.

[0031] In yet another embodiment, the first component is a medication holder configured to hold a medication. In at least some embodiments, the first component data may include a drug hologram. the type of drug in the container, the origin of the drug, the concentration of the drug in the container, the expiration date of the drug, and The first component data may include at least one indication of the volume of the medication in the medication holder. The data may include indicators of compatible drug delivery mechanism parameters.

[0032] In another example, the first component may include a drug delivery mechanism. In embodiments, the first component data may include an indication of the performance of the drug delivery mechanism. The component data may include an indication of compatible medication holder parameters.

[0033] In yet another embodiment, the first component data may be encoded onto the first component .

[0034] In yet another embodiment, the drug is infliximab, golimumab, ustekinumab, dara Tumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine and paliperidone palmitate.

[0035] In another aspect, a drug administration device is provided, in one embodiment, comprising a housing and a drug a medication holder configured to hold the medication and at least partially within the housing; and a syringe configured to dispense the medication and at least partially within the housing. a distribution mechanism configured to store the first component data; a data storage device configured to store the second component data; receiving the first component data and comparing it with the acceptable first component data; and a processor configured to set an operational state of the medication administration device. A drug delivery device is provided.

[0036] The drug administration device may have any number of variations. For example, the data storage device may store drug In another embodiment, the first component data may be stored in a medication holder. Drug type, drug origin, drug concentration in drug holder, drug expiration date, and drug holder The information may include at least one indication of the volume of the drug within the container.

[0037] In yet another embodiment, the data storage device is associated with the housing or the drug dispensing mechanism. In at least some embodiments, the first component data is obtained based on the performance of the drug delivery mechanism. The first component data may include an indication of a compatible drug holder parameter. It may include a mark.

[0038] In another embodiment, the medication holder may be removable from the medication administration device. In yet another embodiment, the drug is infliximab, golimumab, ustekinumab, daratumab Mumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate. [Brief explanation of the drawings]

[0039] The present invention will now be described with reference to the accompanying figures in which: [Figure 1] 1 is a schematic diagram of a first type of drug administration device, namely an autoinjector. [Figure 2] 1 is a schematic diagram of a second type of drug administration device, namely an infusion pump. [Figure 3] FIG. 1 is a schematic diagram of a third type of drug administration device, namely an inhaler. [Figure 4] FIG. 1 is a schematic diagram of a fourth type of drug delivery device, namely a nasal spray device. [Figure 5A] 1 is a schematic diagram of a typical drug delivery device. [Figure 5B] FIG. 1 is a schematic diagram of a universal drug administration device. [Figure 6] FIG. 1 is a schematic diagram of a housing for a dosage form. [Figure 7] 1 is a schematic diagram of one embodiment of a communication network system in which the medication administration device and housing may operate. [Figure 8] FIG. 1 is a schematic diagram of one embodiment of a computer system with which the drug administration device and housing can be operated. [Figure 9] 1 illustrates one embodiment of a method for establishing medication parameters. [Figure 10] 1 illustrates a schematic diagram of one embodiment of data transfer between various elements. [Figure 11]FIG. 1 is a schematic diagram of one embodiment of a medication delivery device, showing a cutaway view to reveal a medication holder within the housing. [Figure 12] 1 is a schematic diagram of an embodiment of an external device for acquiring image data of components of a drug administration device. FIG. [Figure 13] 1 illustrates one embodiment of a method for establishing component compatibility. [Figure 14] FIG. 10 is a schematic diagram of another embodiment of a drug administration device. [Figure 15] FIG. 1 is a schematic diagram of components of one embodiment of a drug delivery system. DETAILED DESCRIPTION OF THE INVENTION

[0040] The structure, function, manufacture, and use of the devices, systems, and methods disclosed herein Certain exemplary embodiments will now be described to provide a general understanding of the principles. One or more examples of these embodiments are illustrated in the accompanying drawings. Any person skilled in the art will appreciate that any of the devices, systems, The methods and methods are non-limiting exemplary embodiments, and the scope of the invention is limited only by the claims. It will be understood that the invention is defined in accordance with the principles of the present invention. The features described herein may be combined with the features of other embodiments. Any shape is intended to be included within the scope of the present invention.

[0041] Furthermore, in this disclosure, like-named components of the embodiments generally have similar characteristics. Therefore, in certain embodiments, each feature of each similarly named component may be In addition, the disclosed system, To the extent that linear or circular dimensions are used in describing devices and methods, such dimensions The present invention relates to a variety of shapes that can be used in conjunction with such systems, devices, and methods. The present invention is not intended to limit the scope of the present invention. Those skilled in the art will appreciate that such a direct It will be appreciated that the equivalent linear and circular dimensions can be readily determined. Those skilled in the art will recognize that even if the dimensions are not exact values, various factors such as manufacturing tolerances and the sensitivity of measuring equipment will be taken into account. It will be understood that the value is likely to be close to that value due to the reasons. The size and shape of the devices and their components are The size and shape of the components may depend at least on the size and shape of the components.

[0042] Examples of various types of drug administration devices include an autoinjector 100, an injection port, The pump 200, inhaler 300, and nasal spray device 400 are shown in the figures referenced above. This is explained below.

[0043] autoinjector FIG. 1 illustrates a first type of drug delivery device that can be used in the embodiments described herein. 1 is a schematic, illustrative diagram of an injection device, in this example, an autoinjector 100. The autoinjector 100 includes a drug holder 110 that holds the drug to be dispensed, and a drug dispenser 112 that dispenses the drug. The device is configured to dispense the medication from the medication holder 110 so that the medication can be administered to the patient. and a dispensing mechanism 120 for dispensing the drug. The drug holder 110 is typically a container for containing the drug. For example, the medication holder 110 may be provided in the form of a syringe or a vial. or any other suitable container capable of holding a drug. 100 includes a discharge nozzle 122, e.g., a syringe, provided at the distal end of the medication holder 110. The dispensing mechanism 120 includes a drive element 124, which itself also includes a piston. The dispensing mechanism 120 may include a piston and / or a piston rod, and a drive mechanism 126. Located proximal to the end of object holder 110 and toward the proximal end of autoinjector 100 do.

[0044] The autoinjector 100 includes a housing 130, and the housing 130 includes a main body. The housing not only houses the medication holder 110, the drive element 124, and the drive mechanism 126, but also Prior to injection, the drug is typically contained entirely within the housing, but during the injection sequence, the drug is The housing also houses a discharge nozzle 122 that extends from the housing 130 for delivery. The dispensing mechanism 120 includes a nozzle 122 for dispensing the drug. , the drive element 124 is advanced through the medication holder 110, thereby causing the auto-injector The vector is adapted to allow the drug held in the drug holder 110 to be administered to the patient. In some cases, the user may drive the drive element 124 through the medication holder 110. Alternatively, the drive mechanism 126 may be manually advanced. The stored energy source 127 may include a stored energy source 127 for propelling the 124. or pressurized gas or electronically powered motor and and / or may include a resilient biasing member such as a gearbox.

[0045] Autoinjector 100 includes a dispensing mechanism protection mechanism 140. The dispense mechanism protector 140 typically has two functions. First, the dispense mechanism protector 140 protects the dispenser before and after injection. Second, the automatic injection may function to prevent access to the discharge nozzle 122 after injection. The injector 100 is armed, e.g., the dispense mechanism protection mechanism 140 is unlocked. When moved to the unloaded position, the dispensing mechanism 120 can function such that it can be activated.

[0046] The protection mechanism 140 prevents the medication holder 110 from being in a retracted position proximally within the housing 130. When the nozzle 122 is inserted, it covers at least a part of the nozzle 122. Alternatively or additionally, the protection mechanism 140 may be The body is configured to retract proximally to expose the discharge nozzle 122, such that: The discharge nozzle 122 can be brought into contact with a patient. The protection mechanism 140 includes a shield member 141. and a return spring 142. The return spring 142 is configured to support the shield member 141 in the housing. 130, so that when no force is applied to the distal end of the protection mechanism 140, When the user overcomes the bias of the return spring 142, the discharge nozzle 122 is covered. When a force is applied to the shield member 141 against the action of the return spring 142, the seal The cover member 141 retracts within the housing 130, thereby exposing the discharge nozzle 122. The protection mechanism 140 may alternatively or additionally prevent the discharge nozzle 1 from reaching beyond the housing 130. 22 may be provided with an extension mechanism (not shown) for extending the discharge nozzle 22 into the housing 130. The protection mechanism 140 may further include a retraction mechanism (not shown) for retracting the lock 122. Alternatively or additionally, a housing cap may be attached to the autoinjector 100. and / or a discharge nozzle boot. When the housing cap is removed, typically The discharge nozzle boot is also removed from the discharge nozzle 122 .

[0047] The autoinjector 100 also includes a trigger 150. The trigger 150 on the exterior of the housing 130 so as to be accessible by a user of the projector 100. The trigger 150 is located at the Upon actuation, trigger 150 acts to release drive mechanism 126, resulting in drive element 124, the drug is then expelled from the drug holder 110 through the discharge nozzle 122. will be done.

[0048] Trigger 150 may also be used, for example, to press the distal end of shield member 141 against the patient's skin. By doing so, the shield member 141 is sufficiently proximally unlocked within the housing 130. The seal is secured in a manner that prevents the trigger 150 from being actuated until it is retracted to the release position. When this is done, trigger 150 is unlocked and the trigger The trigger 150 can then be depressed to initiate the injection and / or drug delivery sequence. Alternatively, the shield member 141 may be used alone. Retracting the drive mechanism 126 proximally into the housing 130 activates the drive mechanism 126, causing the injection and / or may act to initiate a drug delivery sequence. Injector 100 may be configured to prevent, for example, accidental release of dispensing mechanism 120 and / or trigger 15 Device activation prevention mechanism that prevents accidental activation of the device, thereby preventing drug dispensing. It has.

[0049] Although the above description relates to one example of an autoinjector, this example is provided purely for illustrative purposes. As presented, the present invention is not limited to only such autoinjectors. Those skilled in the art will appreciate that various modifications to the autoinjector described will be within the scope of this disclosure. Understand that it can be done.

[0050] The autoinjector of the present disclosure is capable of administering epinephrine, Rebif, Enbrel, Aran Various drugs such as esp, atropine, pralidoxime chloride, and diazepam It can be used to administer either

[0051] infusion pump In other situations, patients require precise continuous delivery of medication or regular doses at set periodic intervals. Infusion pumps can be used to administer medications to patients in a timely or frequent manner, either by a healthcare professional or by the patient. Facilitates administration of drugs at precise rates that keep drug concentrations within therapeutic limits without requiring careful attention By doing so, it is possible to provide such controlled drug infusion. The pump can operate automatically without manual input from the user to administer the medication .

[0052] FIG. 2 illustrates a second type of drug delivery device that can be used in the embodiments described herein. 2 is a schematic, exemplary diagram of an infusion pump 200. Infusion pump 200 delivers a drug holder 210 in the form of a reservoir for containing a drug and by which the drug may be delivered to the patient; and a pump 216 adapted to dispense the drug contained in the reservoir, such that and a dispensing mechanism 220. These components of the infusion pump are housed within a housing 230. The dispensing mechanism 220 further comprises an infusion line 212. The drug is delivered to the pump 216. In operation, fluid is delivered from the reservoir via an infusion line 212, which may take the form of a cannula. The pump 216 may be an elastomeric pump, a peristaltic pump, an osmotic pump, or a syringe pump. Typically, drugs are delivered intravenously, but Subcutaneous, intraarterial, and epidural injections may also be used.

[0053] The infusion pump of the present disclosure is capable of administering insulin, atropine sulfate, avibactam sodium, Bendamustine hydrochloride, carboplatin, daptomycin, epinephrine, levetiraceta oxaliplatin, paclitaxel, pantoprazole sodium, treprostin Any of a variety of drugs, including benzodiazepine, vasopressin, voriconazole, and zoledronic acid It can be used to administer either

[0054] The infusion pump 200 includes control circuitry, such as a memory 297 and a user interface 298. 80, further comprising a processor 296, which together control the trigger mechanism and / or The user interface 280 provides a dose selector for the pump 200. The control circuit may be implemented by a display screen located on the housing 230 of the pump 200. The path and user interface 280 may be located within the housing 230 or external to it. may communicate with the pump 216 via a wired or wireless interface to control its operation. do.

[0055] The operation of the pump 216 is controlled by a process that communicates with the pump 216 to control the operation of the pump. The user interface 280 is controlled by a processor 296. It can be programmed by a user (e.g., a patient or a medical professional) via the This allows the infusion pump 200 to deliver medication to the patient in a controlled manner. The user can input parameters such as injection duration and delivery rate. is typically pre-programmed by the user for a constant infusion rate or for periodic delivery. It can be set as a set interval within programmed limits. The programmed parameters are stored in a memory 297 in communication with the processor 296; The user interface 280 may be a touch screen or In accordance with the present invention, the established dosing parameters can be input to a processor. The device can be used to control the delivery of drugs.

[0056] Power supply 295 is an energy source that provides power to pump 216 and is integral with pump 216. and / or may take the form of a mechanism for connecting the pump 216 to an external power source.

[0057] Infusion pump 200 may take a variety of different physical forms depending on its intended use. Infusion pump 200 may be a fixed, non-portable device, for example, for use at a patient's bedside. or ambulatory infusion devices designed to be portable or wearable. The integrated power supply 295 is particularly useful for ambulatory infusion pumps.

[0058] Although the foregoing description relates to one embodiment of an infusion pump, this embodiment is provided purely for illustrative purposes. The present disclosure is not limited to such infusion pumps. It will be understood that various modifications to the infusion pump may be implemented within the scope of this disclosure. For example, the processor may be configured to automatically generate a pre-defined number of infusion pumps so that the infusion pump does not need to include a user interface. It may be programmed to

[0059] inhaler Figure 3 is a schematic diagram of a third type of drug delivery device, namely an inhaler 300. The container 300 includes a medication holder 310 in the form of a canister. Typically, the inhaler contains the drug in a solution or suspension using a suitable carrier liquid. 00 includes a pressurized gas for pressurizing the medication holder 310, a valve 325, and a nozzle 321. The medication holder 310 further includes a dispensing mechanism 320 including a valve 325 defining an outlet for the medication holder 310. The valve 325 is formed by a narrow opening 324 formed in the medication holder 310 and an opening and a movable element 326 that controls the movement of the moving element 324. When the movable element 326 is in the rest position, The valve 325 is in a closed state, in which the opening 324 is closed and the medication holder 310 is sealed, or When the movable element 326 is actuated from the rest position to the actuated position, the valve 32 5 is actuated to an open state in which the opening 324 is open. Actuation of the element 326 includes moving the movable element 326 into the medication holder 310. The moving element 326 is resiliently biased to a rest position. The drug in solution or suspension with a suitable liquid is then injected through opening 324. The high velocity of the liquid passing through the narrow opening 324 pushes the liquid out of the medication holder 310. The body is atomized, i.e., converted from the bulk liquid into a mist of fine droplets of liquid and / or gas. The patient may inhale a mist of fine droplets and / or a cloud of gas into the respiratory tract. Therefore, the inhaler 300 injects the drug held in the drug holder 310 into the patient's respiratory system. It can be delivered into the tract.

[0060] The medication holder 310 is removably held within the housing 330 of the inhaler 300. A passage 333 formed in the housing 330 is connected to a first opening 333 in the housing 330. 31 and a second opening 332 in the housing 330. The medication holder 310 is The medication holder 310 is received within the passage 333 of the housing 330. 1 and 3. The second opening in the housing 330 is slidably insertable into the passage 333 through the second opening in the housing 330. 332 is a mouthpiece 322 configured to be placed in the patient's mouth or nose a nosepiece configured to be placed within the bore or over the patient's mouth and nose; The mask is configured as follows: The medication holder 310, the first opening 331, and the passage 333 is a flow passage for allowing air to pass through the medication holder 31 between the first opening 331 and the second opening 332. The inhaler 300 is sized to allow the blood to flow through the passageway 333 at about 0. a dispensing mechanism protector 140 in the form of a cap (not shown) that can be fitted onto the dispenser 322; It may be prepared.

[0061] The inhaler 300 includes a trigger 350 that, when activated, activates a valve. trigger 350 including a valve actuation feature 355 configured to actuate valve 325. The valve actuation feature 355 protrudes from the housing 330 into the passage 333. The medication holder 310 is slidable within the passageway 333 from a first position to a second position. In the first position, the end of the movable element 326 in the rest position is movable in the direction of the valve actuation. In the second position, the medication holder 310 abuts the valve actuation feature 355. moves the movable element 326 into the medication holder 310 and actuates the valve 325 to an open state. The user's hand can be displaced toward the valve actuation feature 355 to actuate the drug dispenser. The roller 310 is moved from the first position to the second position against the resiliently biased movable element 326. The valve actuation feature 355 is connected to the nozzle 321 and provides the force necessary to move the valve actuation feature 355. The inlet 356 of the valve actuation feature 355 is connected to the ejected droplets. The mist and / or gas cloud enters the inlet 356 and exits through the nozzle 321 into the passageway 333. 325. The valve 325 is sized and positioned to mate with the opening 324 of the valve 325 so that the Nozzle 321 supports the atomization of bulk liquid into a mist of droplets and / or a gas cloud. Support.

[0062] Valve 325 provides a metering mechanism 370. Metering mechanism 370 dispenses a measured amount of liquid. , and is configured to close the valve after the drug has passed through opening 324. This allows a controlled dose to be administered to the patient. The measured volume of the body is preset, but the inhaler 300 varies the defined volume of the liquid. The inhaler may include a user operable dose selector 360 to select the required dose. A device indicator may be provided to alert the user. The user may then The amount can be set.

[0063] Although the foregoing description relates to one particular example of an inhaler, this example is purely illustrative. The description should not be seen as being limited to only such inhalers. Those skilled in the art will recognize that many other types of inhalers and nebulizers may be used with the present disclosure. For example, can the drug be in powder form, can the drug be in liquid form, Alternatively, the drug may be delivered by other forms of delivery mechanisms including ultrasonic vibration, compressed gas, vibrating mesh, or a heat source. 320 can be atomized.

[0064] The inhaler of the present disclosure can be used to administer mometasone, fluticasone, ciclesonide, budesonide, beclomethasone, Tazone, vilanterol, salmeterol, formoterol, umeclidinium, glycol Copyrrolate, tiotropium, aclidinium, indacaterol, salmeterol, and olodaterol. do.

[0065] nasal spray device FIG. 4 is a schematic diagram of a fourth type of medication delivery device, namely, a nasal spray device 400. 1 is a diagram showing a nasal spray device 400 configured to deliver a medication into a patient's nose. The nasal spray device 400 contains a drug substance therein for delivery from the device 400 to the patient. The medication holder 102 includes a medication holder 402 configured to receive the medication. servers, cartridges, vials (as in this exemplary embodiment), blow fillers It may have various configurations such as Blow-Fill-Seal (BFS) capsules, blister packs, etc. In an exemplary embodiment, the medication holder 402 is a vial. An exemplary vial is , formed of one or more materials, e.g., glass, polymer, etc. In some embodiments, the vial may be made of glass. Alternatively, the polymer may be formed from two or more polymers. The vial may be formed of different materials. Exemplary vials are described herein and shown in Figures 1 and 2. As shown in the figure, the device has various features that facilitate the sealing and storage of drugs within. However, it is possible that a vial may contain only some of these features, and Those skilled in the art will recognize that the present invention may include various other features and / or functions known in the art. The vials described herein are intended to represent specific exemplary embodiments. That's all.

[0066] The opening 404 of the nasal spray device 400 through which the medication exits the nasal spray device 400 is Within the dispensing head 406 of the nasal spray device 400, within the tip 408 of the dispensing head 406 The tip 408 is configured to be inserted into the patient's nostril. In one embodiment, the tip 408 is positioned in the patient's into the first nostril of the patient, and into the second nostril of the patient during a second phase of operation of the nasal spray device 400. The first and second stages of operation are configured to deliver a first dose of drug. a first actuation corresponding to the second dose of drug being delivered; and a second actuation corresponding to the second dose of drug being delivered. In some embodiments, the actuation involves two separate actuations of the nasal spray device 400. The nasal spray device 400 is designed to be actuated only once to deliver one nasal spray. In some embodiments, the nasal spray device 400 may be configured to deliver, for example, four, five, or more doses. For delivery of three or more nasal sprays, such as once, six, seven, eight, nine, or ten doses, It is configured to be activated three or more times.

[0067] The dispensing head 406 is configured such that the longitudinal axis of the dispensing head 406 is aligned with the nose where the tip 408 is inserted. a first nostril and a second nostril of the patient so that the first nostril and the second nostril are substantially aligned with the longitudinal axis of the nostril; The depth guide 410 is configured to contact the skin. Those skilled in the art will appreciate that the manufacturing tolerances and measurement equipment The longitudinal axis may not be precisely aligned due to any number of factors, such as the sensitivity of the device. It will be appreciated that although there may be differences, they may be considered to be substantially aligned.

[0068] In an exemplary embodiment, as shown in FIG. 4, the dispensing head 406 has a tapered shape. , the dispensing head 406 is more flexible at its distal end than at its proximal end where the opening 404 is located. The opening 404 having a relatively small diameter is known to those skilled in the art. As can be seen from the figure, this facilitates spraying of the drug from the opening 404. A spray chamber 412 is configured to pass through before exiting the opening 404. The drug is located within the proximal portion of the tapered dispensing head 406 distal to the portion 404. The rapid passage through the spray chamber 412 allows the spray chamber 412 to produce a consistent spray. The pattern facilitates the creation of a fine mist that exits through the openings 404. Arrows 414 in FIG. indicates the path of drug migration from the drug holder 402 and out of the opening 404.

[0069] In some embodiments, the dispensing head 406 may be configured to allow the nasal spray device 400 to and configured to deliver a dose of drug simultaneously into two nostrils in response to the movement of the nostril. Each may include two tips 408 having an opening 404 therein.

[0070] The dispensing head 406 is pushed towards the medication holder 402, e.g., by the user. Depressing the guide 410 activates the nasal spray device 400. In other words, the dispensing head 406 dispenses the medication from the medication holder 402. and configured as an actuator that is actuated to expel the nasal spray device 400. In an exemplary embodiment, the nasal spray device 400 is The user who operates the nasal spray device 400 is a patient who receives medication from the nasal spray device 400. The nasal spray device is configured to be administered to a patient by a second person for delivery to another person. The device 400 can be operated.

[0071] Actuation, e.g., pressing, of the dispensing head 406 occurs as indicated by arrow 416 in FIG. , configured to allow ventilation air to enter the medication holder 402. The air transports the drug in the drug holder through the tube 418 and then into the metering chamber 420. The metering chamber 420 then pumps the drug through the cannula 422 proximally and into the spray chamber. through chamber 412 and then out opening 404. For example, if a user: In response to releasing the dispensing head 406, such as ceasing to push the dispensing head 406 downward, A biasing spring 426 returns the dispensing head 406 to its default rest position for subsequent operations. The dispensing head 406 is positioned relative to the drug holder 402 for movement and drug delivery.

[0072] Although the foregoing description relates to one particular example of a nasal spray device, this example is purely illustrative. This description is not intended to be limited to such nasal spray devices. Those skilled in the art will appreciate that the nasal spray device 400 can be configured to: It is understood that different embodiments may include different features. For example, a nasal spray device The device 400 may lack a depth guide 410 and / or may include device indicators, sensors, communication One or more of a communication interface, a processor, a memory, and a power supply may include:

[0073] The nasal spray device of the present disclosure is capable of administering ketamine (e.g., Ketalar®), Sketamine (e.g., Spravato®, Ketanest®, and Ketanest-S®), naloxone (e.g., Narcan® sumatriptan (e.g., Imitrex®), It may be used to administer any of a variety of drugs.

[0074] Drug Delivery Devices As will be appreciated from the foregoing, the various components of the drug delivery device are These components are common to all devices. The drug administration device delivers a drug to a patient, the drug being in a defined dosage form. provided in a drug administration device.

[0075] FIG. 5A is a generalized schematic diagram of such a universal drug delivery device 501. FIG. 5B shows an exemplary embodiment of such a universal drug delivery device 500. Examples of universal drug delivery devices 500 include injection devices (e.g., injectors, jet injectors, and infusion pumps), nasal spray devices, and suction Examples include containers.

[0076] As shown in FIG. 5A, the drug delivery device 501, in its general form, includes a drug host The medication holder 10 includes features of a medication holder 10 and a dispensing mechanism 20. The medication holder 10 holds the medication in the dosage form to be administered. The dispensing mechanism 20 dispenses the dosage form from the medication holder 10 so that the medication can be administered to the patient. configured to emit

[0077] FIG. 5B illustrates a further universal drug delivery device 500 that includes several additional features. Those skilled in the art will appreciate that these additional features are optional for different embodiments and may be used interchangeably. the type of item, the drug dosage form, the medical indication being treated with the drug, safety requirements, and the device power source whether the device is portable; whether the device is used for self-administration; Depending on the requirements, such as whether or not the Additional features may be present or omitted from a given embodiment of a particular drug delivery device. It will be understood that various different combinations may be used to obtain the desired results. Similar to the monkey device, the drug administration device 500 comprises a drug holder 10, a dispensing mechanism 20, and The housing 30 accommodates the

[0078] The device 500 is configured to initiate the release of the drug from the drug holder 10 by the dispensing mechanism 20. The device 500 includes a trigger mechanism 50 for dispensing the medication from the medication holder 1 via the dispensing mechanism 20. This includes the feature of the metering / dispensing mechanism 70 that measures the set dose from 0. , the drug delivery device 500 can provide a known dose of a determined size. 00 allows the user to set the dose volume of the drug to be measured by the metering mechanism 50. The dose volume is selected from a plurality of predetermined individual dose volumes. or any value of a given dose volume within a range of dose volumes. The drug delivery device may be configured to adjust the dose volume without user intervention. obtain.

[0079] The device 500 may include the device operation prevention mechanism 40 or 25. When the mechanism 40 or 25 is in the locked state, the dispensing mechanism 20 releases the drug from the drug holder 10. When in the unlocked state, the dispensing mechanism 20 prevents and / or stops the drug from being dispensed. This allows for the release of a drug dose from the holder 10, e.g. to prevent accidental administration of medication, to prevent administration in a hospital, or to prevent inadvertent actuation. The device 500 may also be configured to shut down the dispensing mechanism 20, e.g., for safety reasons. The device includes a dispensing mechanism protection mechanism 42 that prevents access to at least a portion of the device. The device operation prevention mechanism 40 and the dispensing mechanism protection mechanism 42 may be the same component. Each of the stop mechanism and the dispensing mechanism protection mechanism is enabled by the medication administration device without user intervention. It can be enabled and disabled.

[0080] The device 500 may provide information about the status of the drug delivery device and / or the drug contained therein. The device may include a device indicator 85 configured to present information related to the device. The indicator 85 may be a visual indicator, such as a display screen, or an audio indicator. The device 500 may present information about the device 500 to the user of the device 500. and / or configured to allow a user to control the device 500. The device indicator 85 can be used to confirm prompts the user to select the required medication parameters based on the established medication parameters The device indicators 85 may be configured to indicate the dosage required by established medication parameters. If so, the device 500 may prompt the user to administer the medication. Information relating to the administration device and / or the drug contained therein, e.g., dosage form and device The device includes a device sensor 92 configured to sense a device parameter. In embodiments including a quantity mechanism 70 and a dose selector 60, the embodiment may include a dose selector 60. 0, the dose selected by the user, the dose metered by the metering mechanism 70, and and configured to sense one or more of the doses dispensed by dispensing mechanism 20. The device may further include one or more device sensors 92 connected to the device.

[0081] Similarly, an environmental sensor 94 may be provided, which measures the temperature of the environment, the humidity of the environment, The device 500 is configured to sense information about the environment in which it resides, such as location and time. The geographic location of the device 500 is determined, for example, via satellite positioning such as GPS. There may be a dedicated position sensor 98 configured to determine the position of the device 5. The device and / or drug may also be externally monitored to collect data from various sensors. The device may include a communication interface 99 that can communicate with the device.

[0082] Optionally, device 500 may include one or more electrical components of device 500. The device 500 includes a power supply 95 for delivering power to the device. The power supply 95 is integral with the device 500. It may be a power source and / or a mechanism for connecting the device 500 to an external power source. The devices 500 are also powered by a power source 95 and communicate with each other and, optionally, with an environmental sensor. 94, position sensor 98, device sensor 92, communication interface 99, and / or The processor communicates with other electrical and control components of the device 500, such as the indicator 85. The device includes a computer system 90 including a processor 96 and a memory 97. 96 includes the environmental sensor 94, the device sensor 92, the communication interface 99, and the position sensor 98, and / or obtain data obtained from the user interface 80 and process it. and outputting data to, for example, the indicator 85 and / or the communication interface 99. configured to provide a force.

[0083] In some embodiments, the drug administration device 500 is enclosed within packaging 35. The packaging 35 includes a processor 96, memory 98, and 7, user interface 80, device indicator 85, device sensor 92, position The device may further include a combination of position sensors 98, and / or environmental sensors 94, which may It may be located outside the housing of the sensor 500.

[0084] Those skilled in the art will appreciate that the universal medication delivery device 5 comprising the medication holder 10 and the dispensing mechanism 20 00 may have the various optional features described above in several different combinations. It will be appreciated that the medication delivery device 500 further includes a medication holder 504 associated with it. Optionally, two or more dispensing mechanisms 20 may be provided. More than one medication holder 10 may be included.

[0085] Drug dosage form Traditionally, drug delivery devices utilize liquid dosage forms. However, other dosage forms are available. It will be understood that this is possible.

[0086] One such common dosage form is the tablet. Tablets contain a drug and excipients compressed together. Other dosage forms include pastes, creams, powders, ear drops, and eye drops.

[0087] Further examples of drug dosage forms include skin patches, drug-eluting stents, and intrauterine devices. In these examples, the body of the device contains a drug and releases the drug under certain conditions. For example, a skin patch may be constructed to allow the drug to be delivered to the skin. The polymer composition may comprise a composition that allows the drug to diffuse from the polymer composition into the patient's skin. Drug-eluting stents and intrauterine devices may operate in a similar manner. In this way, patches, stents, and intrauterine devices may themselves be associated with It can be thought of as a medication holder with a dispensing mechanism.

[0088] Any of these dosage forms may be configured to trigger drug release upon specific conditions. This allows the drug to be released at a desired time or location after the dosage form is introduced into the patient. In particular, drug release can be initiated by an external stimulus. The dosage form may be contained within a housing, which may be in the form of packaging, prior to administration. This housing may include any of the optional components described above that are utilized in the universal drug delivery device 500. It may include some of the features.

[0089] The drugs administered by the drug administration device of the present disclosure, when consumed, have physiological effects on the organism. or any substance that causes a mood change. Examples of drugs that can be used include 5-alpha-reductase inhibitors, 5-aminosalicylates, 5HT3 receptor antagonists, ACE inhibitors with calcium channel blockers, with thiazides ACE inhibitors, adamantane antivirals, corticosteroids, adrenal corticosteroids Adrenergic bronchodilators, emergency hypertension medications, pulmonary hypertension medications, Ludosterone receptor antagonist, alkylating agent, allergen, α-glucosidase inhibitor Medicines, alternative medicines, amoebicides, aminoglycosides, aminopenicillins, aminosalicylic acids, AMPA receptor antagonists, amylin analogs, analgesic combinations, analgesics, androgens and and anabolic steroids, angiotensin-converting enzyme inhibitors, and calcium channel blockers Angiotensin II inhibitors, angiotensin II inhibitors with thiazides, angiotensin II inhibitors angiotensin receptor blockers, angiotensin receptor blockers and neprilysin inhibitors, anorectal Pharmaceuticals, appetite suppressants, antacids, anthelmintics, anti-angiogenic ophthalmic agents, anti-CTLA-4 monoclonal Antibodies, anti-infectives, anti-PD-1 monoclonal antibodies, anti-adrenergic agents including thiazides (central), antiadrenergics including thiazides (peripheral), antiadrenergics, central acting, antiadrenergic, peripherally acting, antiandrogen, antianginal, antiarrhythmic, Antiasthmatic combinations, antibiotics / antineoplastics, anticholinergic antiemetics, anticholinergic anti Parkinson's agents, anticholinergic bronchodilators, anticholinergic chronotropic agents, anti Cholinergic / antispasmodic, anticoagulant reverser, anticoagulant, anticonvulsant, antidepressant, antidiabetic Antidiabetic drugs, antidiabetic combinations, antidiarrheals, antidiuretic hormones, antidotes, antiemetics / antivertigo drugs , antifungal, antigonadotropic, antigout, antihistamine, hypolipidemic, hypolipidemic Combination, combination of antihypertensive drugs, antihyperuricemia drugs, antimalarials, antimalarials Combination, antimalarial quinolone, antimanic, antimetabolite, antimigraine, antitumor drug combination Combined, antitumor drug antidote, antitumor drug interferon, antitumor drug, antiparkinson drug, anti Platelet inhibitors, antipseudomonal penicillins, antipsoriatic drugs, antipsychotics, antirheumatic drugs, antiseptics and Antiseptics, antithyroid drugs, antitoxins and antivenins, antituberculous drugs, antituberculous combination drugs, antitussives, Antiviral agents, antiviral boosters, antiviral combinations, antiviral inter Feron, anxiolytics, sedatives, and hypnotics, aromatase inhibitors, atypical antipsychotics, Antifungal drugs, bacterial vaccines, barbiturates, anticonvulsants, barbiturates, BCR -ABL tyrosine kinase inhibitors, benzodiazepine anticonvulsants, benzodiazepines, Beta-blockers, including calcium channel blockers; beta-blockers, including thiazides; beta-anticoagulants Adrenergic blockers, beta-lactamase inhibitors, bile acid sequestrants, biologics, bisphosphatase inhibitors phonates, bone morphogenetic proteins, bone resorption inhibitors, bronchodilator combinations, bronchodilators , calcium receptor agonists, calcineurin inhibitors, calcitonin, calcium channels blockers, carbamate anticonvulsants, carbapenems, carbapenem / beta-lactams Anticonvulsants, carbonic anhydrase inhibitors, cardiac stress agents, cardiac Selective beta-blockers, cardiovascular agents, catecholamines, cation exchange resins, CD20 monoclonal antibodies monoclonal antibody, CD30 monoclonal antibody, CD33 monoclonal antibody, CD38 monoclonal antibody Monoclonal antibodies, CD52 monoclonal antibodies, CDK4 / 6 inhibitors, central nervous system drugs , cephalosporins, cephalosporins / beta-lactamase inhibitors, cermenol drugs, CFTR combinations, CFTR potentiators, CGRP inhibitors, chelators, chemokines receptor antagonists, chloride channel activators, cholesterol absorption inhibitors, cholinergic agonists, cholinergic muscle stimulants, cholinesterase inhibitors, CNS stimulants, coagulation modifiers agents, colony-stimulating factors, contraceptives, adrenocorticotropic hormones, coumarins and indanediones, cox-2 inhibitors, decongestants, dermatological drugs, diagnostic radiopharmaceuticals, diarylquinolines, Dibenzazepine anticonvulsants, digestive enzymes, dipeptidyl peptidase 4 inhibitors, diuretics , dopaminergic antiparkinsonian drugs, drugs used in alcoholism, echinocandins Candida, EGFR inhibitor, estrogen receptor antagonist, estrogen, expectorant, factor Xa Factor inhibitors, fatty acid derivative anticonvulsants, fibric acid derivatives, first-generation cephalosporins 4th generation cephalosporins, functional bowel disorder agents, gallstone solubilizers, gamma-aminobutyric acid analogues , gamma-aminobutyric acid reuptake inhibitors, gastrointestinal agents, general anesthetics, genitourinary tract drugs, gastrointestinal stimulants, Glucocorticoids, glucose-elevating agents, glycopeptide antibiotics, glycoprotein platelet inhibitors , glycylcycline, gonadotropin-releasing hormone, gonadotropin-releasing hormone antagonist Drugs, gonadotropins, Group I antiarrhythmics, Group II antiarrhythmics, Group III Antiarrhythmics, Group IV antiarrhythmics, Group V antiarrhythmics, Growth hormone receptor blockade Drugs, growth hormone, guanylate cyclase-C agonist, Helicobacter pylori eradicant, H2 antagonist , hedgehog pathway inhibitor, hematopoietic stem cell mobilizing agent, heparin antagonist, heparin, HER2 inhibitor Antineoplastic agents, herbal products, histone deacetylase inhibitors, hormones, hormone / antineoplastic agents, Dantoin anticonvulsants, hydrazide derivatives, illegal (street) drugs, immunoglobulins, Immunological agents, immunostimulants, immunosuppressants, impotence agents, in vivo diagnostic biological agents, inks Retinomimetics, inhaled anti-infectives, inhaled corticosteroids, inotropics, insulin , insulin-like growth factor, integrase strand transfer inhibitor, interferon, interro Iodine inhibitors, interleukins, parenteral nutrition products, iodinated contrast media, ionic iodine Contrast media, iron products, ketolides, laxatives, antileprosy drugs, leukotriene modifiers, lincomycin derivatives Conductors, local injectable anesthetics, local injectable anesthetics with corticosteroids, loop diuretics Drugs, pulmonary surfactants, lymphatic stains, lysosomal enzymes, macrolide derivatives, macrolides , magnetic resonance imaging contrast agents, mast cell stabilizers, medical gases, meglitinides, metabolic agents, Methylxanthines, mineralocorticoids, minerals and electrolytes, other drugs, other sedatives Pain medications, other antibiotics, other anticonvulsants, other antidepressants, other antidiabetics drugs, other antiemetics, other antifungals, other antihyperlipidemics, other antihypertensives combinations, other antimalarials, other antitumor drugs, other antiparkinsonian drugs, other antipsychotics, other antituberculous drugs, other antiviral drugs, other anxiolytics, sedatives Sedatives and hypnotics, other bone resorption inhibitors, other cardiovascular drugs, other central nervous system drugs, Other coagulation modifiers, other diagnostic dyes, other diuretics, other genitourinary tract drugs, Other gastrointestinal drugs, other hormones, other metabolic agents, other ophthalmic drugs, other otic drugs Other Respiratory Drugs, Other Sex Hormones, Other Topical Drugs, Other Unclassified Drugs, other vaginal drugs, mitotic inhibitors, monoamine oxidase inhibitors, mouth and throat products , mTOR inhibitors, mucolytics, multikinase inhibitors, muscle relaxants, mydriatics, narcotic analgesics Combinations of medications, narcotic pain relievers, nasal anti-infectives, nasal antihistamines and decongestants, nasal Lubricants and cleansers, nasal preparations, nasal steroids, natural penicillins, neprilysin inhibitors , neuraminidase inhibitors, neuromuscular blockers, neural potassium channel openers, next-generation Phalosporins, nicotinic acid derivatives, NK1 receptor antagonists, NNRTIs, non-cardioselective venoms Data blockers, non-iodinated contrast media, non-ionic iodinated contrast media, non-sulfonylureas, non-steroidal anticoagulants Anti-inflammatory drugs, NS5A inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), and nutritional Food supplements, nutritional products, ophthalmic anesthetics, ophthalmic anti-infectives, ophthalmic anti-inflammatory drugs, ophthalmic antihistamines Ophthalmic ophthalmic lubricants and cleaners, ophthalmic diagnostic agents, ophthalmic glaucoma medications, ophthalmic lubricants and cleaners, ophthalmic preparations for eye drops, ophthalmic steroids, ophthalmic steroids including anti-infectives, ophthalmic surgical preparations, oral nutrition Nutritional supplements, other immunostimulants, other immunosuppressants, otic anesthetics, otic anti-infectives, otic preparations, Otic steroids, otic steroids including anti-infectives, oxazolidinedione anticonvulsants, Oxazolidinone antibiotics, parathyroid hormone and analogs, PARP inhibitors, PCSK9 inhibitors, penicillinase-resistant penicillins, penicillins, peripheral opioid receptor antagonists, peripheral Peripheral opioid receptor mixed agonist / antagonist, peripheral vasodilator, peripherally acting anti-obesity agent, Phenothiazine antiemetics, phenothiazine antipsychotics, phenylpiperazine antidepressants, phosphate Binders, PI3K inhibitors, plasma expanders, platelet aggregation inhibitors, platelet stimulators, poly Potassium-sparing diuretics, including enes and thiazides, potassium-sparing diuretics, and probiotics Progesterone receptor modulators, progestins, prolactin inhibitors, prostagrams Randin D2 antagonist, protease inhibitor, protease-activated receptor 1 antagonist, protease asome inhibitors, proton pump inhibitors, psoralens, psychotropic drugs, psychotropic drug combinations Purine nucleosides, pyrrolidine anticonvulsants, quinolones, radiocontrast agents, radiocomplements adjuvant, radiotherapeutic agent, radioconjugate, radiopharmaceutical, recombinant human erythropoietin, Nin inhibitors, respiratory agents, respiratory inhalation products, rifamycin derivatives, salicylic acid, sclerosing agents, 2 Generation cephalosporins, selective estrogen receptor modulators, selective immunosuppressants, selective hormonal inhibitors Phosphodiesterase-4 inhibitors, selective serotonin reuptake inhibitors, serotonin-nor Combination of epinephrine reuptake inhibitors, serotonergic neurointestinal modulators, and sex hormones combination of sex hormones, SGLT-2 inhibitors, and skeletal muscle relaxants; skeletal muscle relaxants; smoking cessation drugs, somatostatin and somatostatin analogues, spermicides, statins, sterile irrigation solutions, Leptogramins, Streptomyces derivatives, succinimide anticonvulsants, sulfonamides drugs, sulfonylureas, synthetic ovulation stimulants, tetracyclic antidepressants, tetracyclines, therapeutic radiation Sexual medicines, therapeutic vaccines, thiazide diuretics, thiazolidinediones, thioxanthenes, Third generation cephalosporins, thrombin inhibitors, thrombolytic agents, thyroid agents, TNF-alpha inhibitors Toxicants, tocolytic agents, topical acne agents, topical agents, topical allergy diagnostic agents, local anesthetics, Topical anti-infectives, topical anti-rosacea agents, topical antibiotics, topical anti-fungals, topical antihistamines, Topical antitumor agents, topical antipsoriatic agents, topical antiviral agents, topical astringents, topical debridements, topical debridements Pigments, topical emollients, topical keratolytic agents, topical nonsteroidal anti-inflammatory drugs, topical photosensitizers topical steroids, topical steroids including anti-infectives, topical rubefacients, topical steroids including anti-infectives, topical Transthyretin stabilizers, triazine anticonvulsants, tricyclic antidepressants, trifunctional monoclonal antibodies Clonal antibodies, ultrasound contrast agents, upper respiratory tract combination agents, urea anticonvulsants, urea cycle disorder agents, urinary Medium anti-infective, urinary antispasmodic, urinary pH adjuster, uterine contraction agent, vaccine combination, vaginal anti-infective Medicines, vaginal preparations, vasodilators, vasopressin antagonists, vasopressors, VEGF / VEGFR inhibitors antivirals, viral vaccines, mucosupplements, vitamin and mineral combinations, vitamins, or The drug administration device of the present disclosure may be used to administer epinephrine, Re, or a VMAT2 inhibitor. bif, Enbrel, Aranesp, atropine, pralidoxime chloride, diazepam , insulin, atropine sulfate, avibactam sodium, bendamustine hydrochloride, Carboplatin, daptomycin, epinephrine, levetiracetam, oxaliplatin, Paclitaxel, pantoprazole sodium, treprostinil, vasopressin, bovine serum albumin Conazole, zoledronic acid, mometasone, fluticasone, ciclesonide, budesonide, benzamidine Clometasone, vilanterol, salmeterol, formoterol, umeclidinium , glycopyrrolate, tiotropium, aclidinium, indacaterol, salmeterol - A drug selected from the group consisting of cyclosporine, cyclosporine, and olodaterol may be administered.

[0090] As noted above, any of a variety of drugs can be delivered using the drug administration device. Examples of drugs that can be delivered using the drug administration devices described herein include Remi Cade® (infliximab), Stelara® (ustekinumab) Mab), Simponi® (golimumab), Simponi Aria® (golimumab), Darzalex® (daratumumab), Tremfy® a® (guselkumab), Eprex® (epoetin alfa), R Isperdal Constra® (risperidone), Invega Su stenna® (paliperidone palmitate), Spravato® ) (esketamine), ketamine, and Invega Trinza® (palmitocin) Paliperidone tetanoate).

[0091] Drug Housing As noted above, the dosage form may be provided in a holder appropriate for the particular dosage form utilized. For example, a liquid dosage form of a drug may be placed in a vial with a stopper or a vial with a plunger prior to administration. The dosage form may be a solid or powdered dosage form, e.g., as a tablet, held in a holder in the form of a syringe. The drug is contained within a housing arranged to hold the tablet securely prior to administration. It is possible.

[0092] The housing may include one or more medication holders, each holder containing a dosage form, e.g. For example, the drug may be in the form of a tablet, and the housing may include a plurality of holders each having a tablet held therein. The holder may be in the form of a recess in a blister pack.

[0093] FIG. 6 shows a housing 63 with a plurality of medication holders 610, each containing a dosage form 611. The housing 630 is designed to be able to withstand various environmental conditions, such as temperature, time, or location. At least one environmental sensor configured to sense information about the existing environment 94. The housing 630 may accommodate the drug in the dosage form 611 contained within the holder 610. at least one device sensor 92 configured to sense information related to For example, determining the geographic location of the housing 630 via satellite positioning such as GPS. There may be a dedicated position sensor 98 configured to determine

[0094] The housing 630 stores information regarding the status of the drug in the dosage form 611 contained within the holder 610. The housing may include an indicator 85 configured to present information to a user of the housing. The housing 630 may also include a drug housing 630, an environment, a time, or a place, and and / or communicating information externally via wired or wireless transmission of data relating to the drug itself. The communication interface 99 may include a communication interface 99 capable of

[0095] Optionally, the housing 630 may include one or more electrical components of the housing 630. The device may include a power supply 95 for delivering power to the components. The power supply 95 is integral with the housing 630. The housing 630 may be a power source and / or a mechanism for connecting the housing 630 to an external power source. The housings 630 are also powered by a power supply 95 and are electrically isolated from each other and, optionally, the environment. sensors 94, position sensors 98, device sensors 92, communication interfaces 99, and / or or indicator 85. The device may include a computer system 90 including a processor 96 and memory 97. The processor 96 is connected to the environment sensor 94, the device sensor 92, and the communication interface 99. , acquiring data obtained from the position sensor 98 and / or the user interface 80 and process it, for example, to provide an indicator 85 and / or a communication interface 9 9.

[0096] The housing 630 may be in the form of packaging. Alternatively, additional packaging may be used. A ring may be present to contain and surround the housing 630 .

[0097] The holder 610 or additional packaging may itself be a device cell, as described above. sensor 92, environmental sensor 94, indicator 85, communication interface 99, power supply 95, A position sensor 98 and a device computer system including a processor 96 and memory 85 The system may include one or more of the following:

[0098] Electronic Communications As mentioned above, the communication interface 99 may be located in or on the housing 30, 630. , or alternatively contained within or on packaging 35 to facilitate drug administration. Such a communication interface may be associated with the device 500 or the medication housing 630. The interface 99 may be connected to a remote computer system such as the central computer system 700 shown in FIG. As shown in FIG. 7, the drug administration device may be configured to communicate with a computer system. The communication interface 99 associated with the housing 630 or the communication network Through network 702, a medical facility 706, such as a hospital or other medical center, a home base 708 (e.g., a patient's home or office, or a caretaker's home or office) 710, access to the central computer system from any number of locations, such as an office, or a mobile location 710. The communication interface 99 is configured to communicate with the network system 700. The system 700 is configured to be accessed via a wired and / or wireless connection to the network 702. In an exemplary embodiment, the communication interface 99 of FIG. 0 is configured to be accessed wirelessly, for example, via a Wi-Fi connection, This may facilitate the accessibility of the system 700 from almost any location in the world.

[0099] Those skilled in the art will appreciate that system 700 may be configured to utilize the features of system 700 available to any particular user. may be based, for example, on the identity of the user and / or the location from which the user is accessing the system. It will be understood that the security features may be included as may be determined based on the To facilitate access to the system 700, each user must have a unique username. , passwords, biometric data, and / or other security credentials. The security parameter information provided determines whether the user is authorized and whether the user is To what extent are you allowed to interact with the system, view information stored in the system, etc. The user may be checked against a database of authorized users to determine if the user is authorized.

[0100] Computer Systems As discussed herein, one or more aspects or aspects of the subject matter described herein may be The components of the central computer system 700, such as the processor 96, the power supply 9 5, memory 97, communication interface 99, user interface 80, device interface The indicators 85, device sensors 92, environmental sensors 94, and position sensors 98 are digital electronic circuits, integrated circuits, specially designed application specific integrated circuits (ASICs) Integrated Circuit (ASIC), Field Programmable Gate Array (Field Pro FPGA (Programmable Gate Array) computer hardware, firmware, and software Various aspects or features of these may be implemented in a variety of ways, including, but not limited to, software, hardware, and / or combinations thereof. , executed on a programmable system including at least one programmable processor. one or more executable and / or interpretable computer program implementations The processor may include a storage system, at least one input device, and at least Receives data and commands from and sends data and commands to at least one output device It can be a dedicated or general-purpose processor connected to A system or computer system may include clients and servers. The client and server are generally remote from each other and are typically connected via a communications network, e.g. , Internet, wireless wide area network, local area network, wide area network The client and server interact via a network or wired network. The components running on each computer and having a client-server relationship with each other It is caused by a computer program.

[0101] A computer program is a program, software, or software application. It may also be called a program, application, component, or code. It includes machine instructions for programmable processors, high-level procedural languages, object-oriented programming languages, functional programming languages, logic programming languages, and / or may be implemented in assembly / machine language. As used herein, the term "machine-readable medium" refers to a "Device" includes, for example, magnetic disks, optical disks, memories, and programmable logic devices. Any computer-programmable device, such as a Programmable Logic Device (PLD) refers to any product, device, and / or apparatus that is capable of receiving machine instructions as machine-readable signals. Includes a machine-readable medium for providing machine instructions and / or data to a programmable processor The term "machine-readable signal" is used to describe a signal that can be used to transmit machine instructions to a programmable processor. A machine-readable medium refers to any signal used to provide data, e.g. For example, non-transient solid-state memory or a magnetic hard drive, or any equivalent storage medium. Such machine instructions may be stored non-transitoryly on a machine-readable medium, such as a processor. processor cache, or associated with one or more physical processor cores or other random access memory in a temporary manner, such as by storing such machine instructions in an alternative or It can be additionally stored.

[0102] To provide for interaction with a user, one or more aspects of the subject matter described herein may be used. The user interface 80 (including the dispensing device 500 or housing 630 or separate) may be used, for example, to display information to the user. Cathode Ray Tube (CRT) or Liquid Crystal Display (LCD) LCD (Light Emitting Diode, LED) monitors and other displays The display screen may be implemented on a computer that can be directly (e.g., touch) screen) or indirectly (e.g., through a keypad or voice recognition hardware and software) Other types of input devices may be used to input data to the display screen. The device can be used to provide for user interaction as well. For example, The feedback provided may be, for example, visual feedback, auditory feedback, or Input from the user, which can be any form of sensory feedback, such as haptic feedback may receive input in any form, including but not limited to acoustic, voice, or tactile input. As mentioned above, this feedback may be displayed on the user interface 80. Additionally, the device may be provided via one or more device indicators 85. The indicator 85 may be used to provide this feedback or to receive input from the user. To receive the signal, the device sensors 92, the environmental sensors 94, and / or the position sensors 98 are used. may interact with one or more of:

[0103] FIG. 8 is an example of computer system 700 shown as computer system 800. 8 shows an exemplary embodiment of a computer system 800. and one or more processors 896 configured to control the 96 may be a programmable general-purpose or special-purpose microprocessor and / or various special-purpose or any one of the commercially available single or multi-processor systems Any type of microprocessor or central processing unit (CPU) The computer system 800 may also include a processor 896. for the code to be executed, or for one or more users, storage devices, and / or one configured to provide temporary storage for data obtained from the database; Or, it includes two or more memories 897. The memory 897 may be a read-only memory (Read-Only ROM), flash memory, one or more of various random access memories Random Access Memory (RAM) (e.g., static RAM, SR AM), Dynamic RAM (DRAM), or Synchronous DRAM M (Synchronous DRAM, SDRAM), and / or a combination of memory technologies .

[0104] The various elements of the computer system are coupled to a bus system 812. The bus system 812 is connected by appropriate bridges, adapters, and / or controllers. Any one or more separate physical buses, communication lines / interfaces connected by abstractions representing the source, and / or multi-drop or point-to-point connections The computer system 800 also includes one or more network interfaces. interface 899 (also referred to herein as a communication interface), one or two or more input / output (IO) interfaces 880, and one or more The above storage device 810 is included.

[0105] The communications interface 899 allows the computer system to communicate with remote devices, e.g. , and network with other computer systems and / or devices 500 or housing 630. may be configured to allow communication over a network, or may be configured to allow communication over a remote Desktop connection interface, Ethernet adapter, and / or other local It can be a Local Area Network (LAN) adapter. Interface 880 is one or more devices for connecting computer system 800 to other electronic devices. includes two or more interface components. For example, IO interface 880 includes , Universal Serial Bus (USB) port, 1394 port, Wi-Fi, Blue Additionally, the computer system may include a high speed data port such as a The IO interface 880 may be accessible to users throughout the Playback, speakers, keyboard, pointing device, and / or various other video , audio, or alphanumeric interfaces. This includes any conventional medium for storing data in a transient and / or non-transitory manner. Thus, the storage device 810 retains values ​​despite interruptions in power to the computer system. The storage device 8 is configured to hold data and / or instructions in a persistent state. 10. One or more hard disk drives, flash drives, USB drives drives, optical drives, various media cards, diskettes, compact discs, and and / or any combination thereof, either directly connected to a computer system; Or it may be remotely connected to a computer system, such as via a network. In an embodiment, the storage device 810 may be, for example, a hard disk drive, a flash drive, USB drive, optical drive, media card, diskette, or compact disc A tangible or non-transitory computer-readable medium configured to store data, such as a disk Including the body.

[0106] The elements illustrated in FIG. 8 may be some or all of the elements of a single physical machine. In addition, not all of the illustrated elements need be located on or within the same physical machine. do not have.

[0107] The computer system 800 may process a web page or other markup language stream. to search, and to browse (visually, audibly, or otherwise) those pages and / or streams; presenting the page / stream in a way that allows scripts, controls, and other commands to be executed on those pages / streams to execute commands (e.g., to complete input fields) on those pages / Accepting user input for a stream, H for those pages / streams Issues a HyperText Transfer Protocol (HTTP) request or by other means (e.g., by submitting information from completed input fields to a server). This may include a web browser for displaying web pages or other markup languages. The term stands for HyperText Markup Language (H TML), or Embedded Extensible Markup Language (EML) and other traditional forms including Markup Language (XML), scripts, controls, etc. The computer system 800 may also generate web pages and / or It may include a web server for distribution to an external computer system.

[0108] As shown in FIG. 7, the computer system 800 of FIG. 8 may include one or more The device computer of the two or more individual drug administration devices 500 or housings 630 a central computer system 700 in communication with one or more of the data systems 90; Operational data of the device 500 or the housing 630, such Data, such as patient medical data, acquired by the device 500 or housing 630 can be exchanged between the central and device computer systems 700, 90.

[0109] As previously mentioned, the above-described computer system 800 may also be used in conjunction with the drug administration device 500 or The device computer system may be integrated into the housing 630 or may be located in close proximity to the housing. In this regard, one or more processors may form a component of system 90. 896 corresponds to the processor 96, and the network interface 899 is a communication interface. The IO interface 880 corresponds to the user interface 8 0, and memory 897 corresponds to memory 97. Furthermore, additional storage device 810 also It may also reside within the device computer system 90.

[0110] In an exemplary embodiment, the computer system 800 may be configured to, for example, administer a single drug A single one or more medication delivery devices 500 housed within the seat housing 30. The package 35 is housed in a housing 630 that includes a plurality of medication holders 610. The devices may be integrated to form a single unit computer system 90. The computer system 800 may be used as a single unit, as a single server, or as a single task. As a work, a central computer system 700 may be formed.

[0111] A single unit may be configured such that its various aspects do not disrupt the functioning of any other aspect of the system. can be swapped out as needed, for example for upgrades, replacements, or maintenance, without It can be modular so that it can be plugged in and out. may also be extensible with capabilities added as additional modules, and / or Additional functionality of existing modules is desired and / or improved.

[0112] A computer system may also include, by way of example, an operating system and a database. Among various other software and / or hardware components, including management systems An exemplary computer system is shown and described herein. Although the present invention is illustrated in detail below, it will be understood that this is for generality and convenience only. In some embodiments, the computer system may be architecturally different from that shown and described herein. In a non-limiting example, the memory 897 and storage device 81 The 0 can be integrated together or where communication with another computer system is not required. In this case, the communication interface 899 may be omitted.

[0113] Implementation It is desirable to monitor compliance with the guidance associated with drugs administered to patients in various dosage forms. This provides assurance that the correct procedures are being followed and This avoids the need for precise and potentially dangerous approaches. It may also be possible to optimize the administration of substances.

[0114] Additionally, the correct dosage for the particular drug present in the drug administration device for delivery to the patient may be determined. It may be desirable to ensure that the drug administration device is Ensuring that a patient is in the proper condition to administer the desired dose is crucial to ensuring that the correct dose is administered. It may be helpful to ensure that the dosage regimen is used.

[0115] Establishing medication parameters In an exemplary embodiment, a method for establishing dosing parameters for a drug administration device includes: obtain drug holder data from a drug holder of a drug administration device, and process the drug holder data; The medication administration device may include a processor or may communicate with an external processor. The method also includes the step of: communicating at least a relevant subset of the medication parameters from the server to the processor; Establishing medication parameters for a medication delivery device based on a relevant subset of data and the relevant subset of medication parameter data is determined based on the medication holder data. It is determined.

[0116] The method for establishing medication parameters for a medication delivery device may include determining the specific details of the medication holder. It can also ensure that the correct dosage parameters are established for each individual. By obtaining a relevant subset of medication parameter data, up-to-date medication parameters are available for drug administration. It may be possible to ensure that the drug is administered to the device. The optimal medication registration for a patient is achieved regardless of when the holder and medication delivery device were issued to the patient. This can ensure that members are utilized.

[0117] The drug delivery device may be any of the drug delivery devices described herein. In particular, the drug administration device may be an infusion pump as described herein (e.g., infusion pump 2 of FIG. 2). 00) without intervention by the user of the drug delivery device, Therefore, it may be configured to automatically administer the drug.

[0118] A drug delivery device is a device that requires user input to initiate drug delivery. The drug administration device may be a device that alerts the user to administer the drug. The device indicators may include a display screen or audio indicator as described above. This allows the drug delivery device to administer a medication regimen based on established medication parameters. It may be possible to prompt the user to specify.

[0119] The established dosing parameters are determined by dispensing a dose of a drug from a drug delivery device. The established dosing parameters may be associated with any number of associated parameters. may relate to only one parameter associated with the administration of the drug from the administration device; or The established medication parameters may include a plurality of parameters associated with the administration of the medication from the medication administration device. The parameters may be related to:

[0120] In an example of a medication parameter, the medication parameter may be a parameter that determines when a medication is to be administered from a medication administration device. In another example of a dosing parameter, the dosing parameter may relate to the frequency with which the drug should be administered. The dosage parameters may indicate a specific time at which the drug is to be administered from the drug administration device. In the example, the dosing parameter may relate to the volume of drug administered by the drug administration device. Another example of a medication parameter is the dosage parameter, if applicable to the drug delivery device being utilized. A medication parameter may refer to the rate at which a medication is administered from a medication administration device. In another example of the data, the dosing parameters may relate to the temperature at which the drug may be administered. In this way, the drug is released from its cold storage temperature (e.g., when stored in a refrigerator) to a warm temperature. The drug reaches a safe temperature that is comfortable for the patient, such as after it has reached a sufficient temperature after being applied. If the temperature of the drug is one of the relevant dosing parameters, In this case, the drug administration device may include a temperature sensor, such as a thermistor, a thermocouple, or a thermistor. The device may include a suitable sensor configured to monitor the temperature of the medication, such as

[0121] In an exemplary embodiment, the established medication parameters are used to administer the medication from the medication delivery device. This defines all of the parameters that can be varied when administering the drug. The parameters provide a dosage regimen for the drug in the drug holder.

[0122] The dosing regimen is an algorithm stored in memory. a memory on-board the medication administration device, for example, and connected to a processor of the medication administration device; Thus, the memory 97 of the drug administration device 500 of FIG. 5B may be executable. The memory may be external to the medication administration device, separate from the medication administration device, and Notes on external devices configured to communicate electronically (wired or wirelessly) with the device It may also be a

[0123] The algorithm provides commands, notifications, and other information to control the administration of medication from the medication delivery device. One or more sets of data points that define and / or represent a signal, etc. As discussed herein, the data may be stored in the form of, for example, a communication interface. The medication holder data received by the processor as a plurality of data points includes: It may be used by the processor to establish the medication parameters of the algorithm. The parameters are between the data points of the algorithm, and therefore each By changing one or more of the stored data points of the rhythm can be changed.

[0124] The medication parameter data received by the processor is used to establish medication parameters. After the medication parameters are established, the Subsequent algorithm execution will administer medication according to an algorithm that reflects the current medication regimen. Another dose of the substance is administered.

[0125] Establishing medication parameters can be automated to improve patient outcomes. Thus, the drug administration device facilitates patient-based personalized medicine and The present invention may be configured to provide a smart system for

[0126] The drug administration device may, based on the established dosing parameters, e.g., by a processor: It may be configured to operate based on the execution of an algorithm that defines a dosing regimen. For example, if the drug administration device is configured to administer the drug without user intervention, If so, the established dosing parameters may relate to the time at which the drug dose should be administered. The operation of the drug delivery device delivers the drug at a time established by the time-related drug delivery parameters. As noted herein, the drug delivery device also The volume of drug dispensed based on the establishment of dosage parameters related to the volume of drug administered. Additionally, the drug administration device may be configured to regulate any other established medication. It can be configured to change its behavior based on the parameters.

[0127] The drug holder of the drug administration device may be of any suitable form for holding a drug. As described herein, such suitable forms include vials, cartridges, etc. Includes a syringe or syringe.

[0128] The medication holder includes medication holder data. the medication holder as part of a data storage component that is part of or otherwise part of the medication holder. For example, the data storage component may include medication holder data from a medication holder. The data storage component may be in the form of an integrated circuit configured to communicate with the In another embodiment, a radio frequency identification (RFID) tag is used. In yet another embodiment, the data storage component may be in the form of a bar code. The medication holder data may be stored in a single data storage component or in multiple data storage components. The data storage element can be used to store the medication holder. If so, each may be different from the other, which is because a particular type of data communication is currently If unavailable, for example, if the RFID scanner is missing or damaged, However, it may be useful to provide redundancy and / or enable retrieval of medication holder data. There is a match.

[0129] Generally, the approach taken to obtain drug holder data involves Therefore, obtaining drug holder data depends on the form in which the data exists. a suitable communication interface for receiving medication holder data communicated from the medication holder; For example, if the medication holder data is contained as part of the RFID tag, In this case, obtaining the medication holder data involves the use of an RFID scanner. In an embodiment, if the medication holder data is contained in the form of a bar code, the bar code In yet another embodiment, the medication holder data can be stored in an integrated circuit. When in the form, the integrated circuit is powered and transmits the medication holder data to the receiving communication interface. It may be possible to send the message to the interface.

[0130] The medication administration device includes one or more medication holders configured to receive medication holder data. components, such as a barcode scanner, RFID scanner, or other suitable communication interface. This localized interface may include a device interface for sending and receiving medication holder data. The configuration may include a communication between the data storage component and the component for receiving medication holder data. Close proximity reduces data storage requirements for barcodes and barcode readers etc. The drug holder data stored in the data storage component is required to read the drug holder data. Alternatively, the device may be configured to acquire medication holder data. The components may be separate from the medication administration device. In particular, the medication holder data may be stored externally. As mentioned above, the external device may determine the medication parameters. The processor may be involved in establishing the The obtained medication holder data may provide the processor with easy access to medication parameters. do.

[0131] The medication holder data communicated from the medication holder to the processor is used to , computer processing involved in establishing the medication parameters performed by the processor At least a relevant subset of medication parameter data can be included in the , are communicated from the server to the processor. In this way, the processor It is at least part of a client to server relationship.

[0132] As discussed above, the relevant subset of medication parameter data may be the relevant subset only, or Any of the entire medication parameter data, including the relevant subset as a partial part, is processed. the processor is configured to use the dose parameters for the drug delivery device in establishing the dose parameters for the drug delivery device. Use a relevant subset of medication parameter data, in other words, establish medication parameters are not used to process the data, and in at least some cases are not even sent to the processor. There may be other medication parameter data available on the server that is not included in the other medication parameters. The data does not relate to a specific drug in the drug holder and / or to a specific drug administration. May not be used because it is not device related. In any case, medication parameters At least a relevant subset of the data used to establish the It is believed.

[0133] Generally, the amount of medication parameter data provided from the server to the processor is Depending on where the relevant subset of data data is determined, the relevant subset of data data may be determined. If the subset is determined on the server, the processor may Since none of the other non-related medication parameter data is required, Only the relevant subset of metadata can be communicated from the server to the processor. This avoids unnecessary This avoids the transmission of medication parameter data, thus increasing the efficiency of the communication process. Alternatively, relevant subsets of medication parameter data may be populated along with unrelated medication parameter data. a processor that can communicate with the medication administration device or an external device The processor can be used to determine the relevant subset of medication parameter data.

[0134] The medication parameter data is communicated from the server to the processor (where the medication parameter data is whether or not it contains unrelated medication parameter data, in the same location as the processor, e.g. For example, in the memory of a medication administration device including a processor or an external device including a processor. In this way, any non-associated medication parameter data can be loaded into the processor. can be stored locally so that they can be used later. The drug holder changes for different types of drug holders with new drug holder data added. When modified, what was previously an unrelated subset of medication parameter data is now related. By storing medication parameter data locally, New medication parameters can be established without the need for further communication with the server. Even if the medication parameter data is not received and therefore not stored locally ,Quality control, patient adherence by storing relevant subsets of medication parameter data. For reasons such as:

[0135] As mentioned above, the medication parameters may be stored in a medication parameter database, for example, using a processor. the relevant subset of medication parameter data is established based on the relevant subset of medication parameter data, This determination may be made in a variety of ways. In some embodiments, the medication holder data defines a medication regimen and is modifiable by the processor. Identify each of the parameters of the algorithm that can be changed. These parameters are also referred to herein as "variable parameters." corresponds to one of the medication parameters in the medication parameter data. However, one or more of the medication parameters in the medication parameter data are The meter is not associated with a specific medication delivery device and / or a specific drug is not associated with the medication delivery device. Because the drug is delivered from a device, it has corresponding parameters within the dosing regimen algorithm. For example, drugs may be stored at room temperature, thus ensuring comfortable delivery to the patient. The temperature of the drug may not be relevant because no time is required to warm it up to the required temperature. In embodiments, the drug may be configured to be delivered on demand from a drug administration device. Therefore, there is no specific time for a drug to be automatically delivered by a drug administration device. In yet another embodiment, the drug delivery device may deliver only a preset dose of the drug. The volume of drug delivered may be configured to deliver a drug of any volume, so that the volume of drug delivered is not relevant. Thus, determining the relevant subset of medication parameter data includes determining the relevant subset of medication parameter data. which of the medication parameters in the medication holder data have corresponding parameters in the medication holder data; In turn, which of the medication parameters in the medication parameter data is used by the medication regimen algorithm? The method may include determining whether the rhythm has a corresponding variable parameter within the rhythm. Using a look-up table or a drug holder data associated with each parameter and comparing the identifier data contained in the medication parameter data to the medication parameter data. Which of the associations in the medication parameter data match the identifiers in the medication holder data? It may be a simple comparison, such as by identifying whether the file has an identifier attached to it. Thus, the established medication parameters govern the delivery of the medication from the medication holder of the medication administration device. In this way, the drug administration device is This can ensure that the patient has the necessary dosing parameters established.

[0136] The method may also include communicating the medication holder data from the processor to a server. A relevant subset of the medication parameter data may then be determined on the server. This determination ensures that only the relevant subset of medication parameter data is communicated from the server to the processor. This decision can be made on the server, which can be an efficient approach to ensure that the communicates a relevant subset of the data parameter data from the server to the processor. This allows for the saving of communication resources such as bandwidth.

[0137] The method may include communicating the medication administration device data from the processor to a server. Medication administration device data is data associated with aspects of a medication administration device. Generally, medication administration device data contains data related to the capabilities of a medication administration device. obtain.

[0138] For example, medication delivery device data may include information related to the rate at which medication is delivered from a medication delivery device. The speed may be related to the capabilities of the associated drug administration device. For example, a component of a device may depend at least in part on one of the components. One or more may become dysfunctional and / or ineffective for any future drug delivery. This may allow for the maximum possible delivery rate.

[0139] In another embodiment, the medication administration device data can be administered by a medication administration device. The medication holder may have a maximum amount of medication that it can hold. , which is the maximum amount of hydroxybenzoate that can be delivered from a drug administration device, at least for single-use devices. Defines possible dose sizes. If the drug administration device is a nasal spray device or an inhaler, e.g. In the embodiment of the inhaler 300 of FIG. 3, the dose size is typically 100 sq ft, e.g., a nasal spray device. Responds to manual depression of the dispenser head (nozzle) of the device or the medication holder (canister) of the inhaler and a specific set amount (or a specific range) defined by how much drug is released. (amount of).

[0140] In yet another embodiment, the medication administration device data is stored in a medication administration device, e.g., Specific forms such as injectors, infusion pumps, inhalers, and nasal spray devices should be identified. In this way, the medication administration device data can be used to identify the medication administration device at least It can also be distinguished from one other form of drug delivery device.

[0141] The medication administration device data is stored in a database that the server uses to determine the relevant subset of medication parameter data. Instead of also sending a non-relevant subset of the medication parameter data to the processor, In an embodiment where only a relevant subset of the metadata is sent to the processor, In this way, the relevant subset of medication parameter data can be stored in the medication holder data. for the medication in the medication holder, and based on the medication administration device data, It can be ensured that it is suitable for the drug administration device.

[0142] Data communications between the various components in the various embodiments described herein are encrypted. In an exemplary embodiment, communications between the processor and the server may include encrypted communications. The communication between the medication holder and the processor may include encrypted communication. The use of encrypted communications increases security and reduces the risk of unauthorized communications occurring. Reduce the risk that such unauthorized communications may adversely affect the operation of the medication delivery device. It is therefore beneficial to prevent such unauthorized communications from occurring. Possible encryption algorithms that can be used include the Data Encryption Standard (DES). dard, DES), TripleDES, RSA, Advanced Encryption Standard Standard, AES), and TwoFish.

[0143] In an exemplary embodiment, a key base such as a public key / private key cryptosystem is used. The security system of the device can be used to encrypt and decrypt data. The public and private keys can be stored in memory and The key can be generated using a cryptographic algorithm to encrypt the data for transmission. and decrypting encrypted data received from different computing devices. In such a system, the data can be associated with the intended receiver. The public key can be used to encrypt data, but the recipient's private key cannot be used. Only the private key can be used to decrypt the encrypted data. In some embodiments, one or more third parties known as "certificate authorities" can be used to prove ownership of a public and private key pair. Cryptography, such as public key infrastructure (PKI) An example of a key-based security system is the Diffie-Hellman key Exchange Protocol, Digital Signature Standard (DSS) Protocol ,Password-Authenticated Key Agreement Protocol, Rivest-Shamir-Adelman ( RSA) encryption algorithm, Cramer-Shoup cryptosystem, and YAK authentication Key agreement protocols include:

[0144] More specifically, encryption is the process of converting text or other data into an unrecognizable data using a key. encrypts a message by converting it into digital form and then restoring it to its original form. This is achieved with an encryption and decryption algorithm. The longer the key, the more effort it takes to break the code. Computer keys are bits of information of various lengths. For example, an 8-bit key has 256 possible values ​​(2 to 8). In another example, a 56-bit key creates 72,000 trillion possible combinations. If the key is 128 bits long, or 16 characters on a personal computer message, a brute force attack would take much longer than breaking a 56-bit key. 47 sextillion (4,700,000,000,000,000,000,000) times more difficult Encryption provides a means to protect against the risk of data being intercepted by an unauthorized party. Even in rare cases, unauthorized use of data is largely prevented.

[0145] A unique identification (ID) number or code must be provided on any pre-use manufacturing During the process, etc., in the memory of the sending device (e.g., drug administration device, server, etc.) The ID number / code is unique to the sending device, but the ID The number / code is common to multiple devices, allowing you to analyze trends across multiple related devices Additional identification, such as a model or model family number or code, that may be useful in In an exemplary embodiment, the ID number may include information about the device. When it arrives, it is sent to the recipient along with data that facilitates the recipient's identification. The recipient will then communicate this identification to the ID number of the sender device that can communicate with the recipient. / I with a lookup table stored at the receiving end that correlates the code to a particular key This can be done in any number of ways, such as by looking up the D number / code, As a result, the receiver will have a unique identifier that it can use to decrypt the data received from the sending device. The lookup table also stores ID numbers / The ID number / code can be correlated to a specific sending device. The receiver must read the ID number / code and identify the correct key to use for decryption. Encryption is performed within the data sent from the sending device to the receiving device to allow There may be cases where this is not the case.

[0146] The key generated by the sending device for communicating with a specific recipient is and stored in the receiver's memory at the receiver, as discussed above. In some embodiments, the sending device generates the key and stores it for storage at the receiving device. Instead of sending the key to the recipient, the recipient generates the key and sends it to the sending device. The key can be sent to the sending device for storage on the device. Using a particular key generation protocol, as will be understood by those skilled in the art, Each of the receiving and sending devices participates in key generation so that the key is shared between the receiving and sending devices. and the sending device to one or the other, which avoids key transmission. This provides security by preventing the key from being intercepted by unauthorized parties. It may help to improve it.

[0147] Hashes are used to authenticate the source of the various data communicated between the elements described herein. For example, the intended recipient of the data (e.g., a drug delivery device) A randomly generated number can be sent to the source of the data. The source of the data (such as a server or medication holder data storage component) can then A shash function can be used to create an encrypted identifier. The encrypted identifier verifies the authenticity of the communication by decoding and verifying the identifier. The encrypted identifier is sent to a recipient who can A serial number or batch number may also be combined and used to identify the medication holder. Encryption can be further differentiated by bandwidth, storage size, and / or processing speed. As opposed to encrypting all data to save on processor speed, may only be used.

[0148] As mentioned above, the established dosing parameters may be stored in the memory of the drug administration device. In this way, the drug administration device has locally stored medication parameters. and the medication parameters of the operation of the medication administration device, regardless of communication with the medication holder or server. In some cases, data may be available.

[0149] In certain embodiments, the memory of the drug administration device has medication parameters preprogrammed therein. This may be due to the fact that the drug has been programmed or as a result of a previous process for establishing dosing parameters. Before establishing the dosing parameters, the device may already have the dosing parameters stored internally. For drug delivery devices that already have medication parameters stored internally, The dosage parameters can replace existing dosage parameters stored in memory. and the method may include updating these dosing parameters accordingly. Updates to relevant medication parameters are made if existing medication parameters are no longer relevant. The data is updated on the server or new medication parameter data is added to the drug administration data. either now relevant in light of changes in the device's drug holder Therefore, it may be advantageous.

[0150] The method of operating a drug delivery device includes the steps of: and assessing the suitability of the dosing parameters. Preventing drug dispensing from a drug delivery device when dosing parameters are not suitable and if the medication parameters are suitable, a drug administration device is and dispensing the drug from the device. to ensure that the drug delivery device does not attempt to achieve unsuitable dosing parameters. The medication parameters may be determined by the ability of the drug delivery device to deliver the medication parameters. The dosage parameters may not be suitable because they are incompatible with the drug administration parameters. in terms of the possible effect that dosing parameters may have on a patient receiving the drug from a given device. For example, a given patient may have any number of characteristics, such as age, diagnostic condition, etc. For reasons, there may be a maximum or minimum dose volume suitable to be administered to a patient. This maximum or minimum dose volume may vary from what is suitable for a given patient. There are cases where this happens.

[0151] The evaluation of the suitability of the medication parameters can be performed by a processor. If the data is found to be unsuitable, the drug administration device may be It may be configured to prevent dispensing of the medication, such as by using an anti-motion mechanism. The drug administration device is further configured to alert the user to the presence of unsuitable medication parameters. This allows the user to overcome the possible current unavailability of the drug delivery device. The warning may be, for example, an audible warning, and If the dosing parameters are not considered suitable, the drug may be The drug delivery device is configured such that unsuitable medication parameters are stored in the memory of the drug delivery device. In this way, the drug administration device can be configured to prevent the Therefore, the drug will be dependent on previously accepted dosing parameters that have been memorized. The administration device can continue to operate in a previously acceptable manner.

[0152] Evaluating the suitability of the dosing parameters may involve adjusting the dosing parameters to suit the drug delivery device or may include comparing with acceptable dosing parameters stored in a memory of the external device. In this way, dosing parameters can be determined to be those that are considered acceptable for drug administration. It can ensure that medication parameters are followed.

[0153] Generally, acceptable parameters indicate successful delivery of a drug from a drug administration device. Define the value (or range of values) of the acceptable parameters. and / or the drug is delivered by a drug administration device. The drug administration device may be predefined before use, for example by , the acceptable parameters are: when the drug administration device is in an injector including a needle; This may include the speed at which the needle of the drug delivery device is inserted into the patient. If the speed is too slow, the needle may not be inserted. In yet another embodiment, the acceptable drug delivery rate is 100%. The parameters that can be measured include the motor speed or duration of motor operation of the drug delivery device. If it is too slow, drug delivery may fail. If the duration is too short, drug delivery may fail. The parameters may include the flow rate of the drug administered by the drug administration device. If the drug delivery is too slow, the drug delivery may fail. If the temperature is too low, the drug may become inflamed, making delivery of the drug to the patient unpleasant. This may indicate that the temperature is likely to be low enough to

[0154] In embodiments where the drug administration data includes authentication data, the medication parameters are determined in two possible states: The first state may include parameters for forgery, the second state having only one state, and the third state may include parameters for forgery detection. The first state indicates that a counterfeit has not been detected, and the second state indicates that a probable counterfeit has been detected. The first condition is to define acceptable parameters for forgery. The parameters for the first state of forgery are the algorithms that define the medication regimen. It allows you to administer the drug according to the rhythm parameters. The parameters for prevent the drug from being dispensed from the drug delivery device. Therefore, the parameters for forgery can potentially be secured by being in a second state, for example. This can provide a safety mechanism to prevent unauthorized drug delivery. If the parameter is determined to be in a second state, the device operation prevention method described herein is performed. By using a stopping mechanism, and / or by the processor executing the algorithm, Define medication regimens in various ways, such as by the rhythm being contraindicated It may be prevented from being administered according to the parameters of the algorithm.

[0155] In an exemplary embodiment, parameters, e.g., dosing parameters and acceptable parameters, are The comparison with the data is performed by a processor, which, as discussed above, Each of the medication parameters and the processor of the administration device or an external device may be The comparison with the acceptable parameters can be done in a variety of ways. For example, The data may include a predefined range of values, and the comparison may be performed to determine whether the medication parameter is within the range of the predefined range. Determine whether the drug delivery rate is within a defined range, thereby indicating successful drug delivery. In another embodiment, the acceptable parameters include a predefined threshold value. The comparison can determine whether the medication parameter exceeds a predefined threshold value. In another embodiment, acceptable drug delivery may include determining whether or not a drug has been successfully delivered. The parameter may include a predefined threshold value, and the comparison may be performed to determine whether the medication parameter is , determine whether the value of the predefined threshold is below, thereby indicating successful drug delivery. This may include showing.

[0156] The method further comprises: converting authentication data associated with the medication parameter data into acceptable medication parameters; The authenticity of medication parameter data can be assessed by comparing it with meter authentication data. By assessing the authenticity of the medication parameter data, the medication regimen can be This can reduce the likelihood that fraudulent medication parameter data will be used to form The method may further or alternatively comprise administering to the drug administration device and / or the drug holder of the drug administration device. by comparing the authentication data associated with the drug with acceptable authentication data. and evaluating the authenticity of the drug administration device and / or the drug holder of the drug administration device. Evaluating the authenticity of the medication administration device and / or the medication holder of the medication administration device This makes it possible to detect counterfeiting.

[0157] The authentication data may be sent as part of the medication parameter data provided by the server. or sent alone in embodiments where authentication data is utilized rather than medication parameter data. The authentication data may be encrypted to increase the security of the authentication data. Authentication data associated with medication parameter data and acceptable medication parameter authentication data The comparison with the authentication data may be performed by a processor. or authentication data associated with a medication holder of a medication administration device and acceptable authentication data The comparison with the data may be performed by a processor. and acceptable authentication data stored in memory either in the external device or in the medication administration device. It can be remembered.

[0158] The authentication data may have various configurations. For example, the authentication data may be stored in a database of the medication administration device and and / or the medication holder of the medication administration device can be specifically identified. The authentication data identifies the medication delivery device as an authorized device containing an authorized medication. and / or the medication administration device as an approved holder for containing approved medications. Identifying the medication holder, thereby ensuring the patient receives the correct medication and payment for the medication the person receiving the medication (e.g., the patient, the patient's insurance company, the hospital, or other medical care facility where the medication is administered to the patient). can be useful in helping ensure that a supplier (such as a retailer or facility) pays for the correct product. The authentication data uniquely identifies the medication administration device and / or the medication holder of the medication administration device. unique electronic identification (UID) code (digits) that identifies and / or alphabet) or by using light reading A drug administration device and / or a drug administration device drug that can be read by a reading device The drug delivery device and the drug delivery system can be attached to the drug delivery device in various ways, such as by using invisible ink printed on the drug delivery device holder. and / or the medication holder of the medication administration device may be specifically identified.

[0159] In at least some embodiments, the authentication data is stored on the medication administration device and / or or in tracking medication holders in medication delivery devices, which can prevent fraudulent This may help identify and / or prevent the diversion of drugs to parties. May require tracking documentation or have tracking documentation of drug locations throughout the supply chain For example, if you are supplying esketamine, ketamine, or other controlled substances, it may be prudent to Tracking within the supply chain meets government requirements, such as the US federal government's Drug Enforcement Agency. Cement Administration requirements, non-federal requirements, state In another example, the supply chain may be required by a government or regulatory requirement. Tracking drugs in this way can prevent diversion and / or help determine how, when, and where diversion occurs. / or it may be a sensible course of action to help determine where it originated. In yet another embodiment, tracking drugs through the supply chain may involve determining whether delivery schedules are consistent with shipping plans. Ensure that the analysis of inefficiencies in the process is amenable to and / or facilitated It may be useful to:

[0160] Authentication data used during shipping is used to verify the authenticity of the drug from the manufacturer to the end site for use. During transport of the administration device, authentication data is obtained at each planned shipping location and the drug administration device is The medication holders of the medication administration devices and / or the medication devices are delivered to the planned shipping locations and in the planned manner. This may involve verifying that the data was received correctly. For example, authentication as UID data. If the data is contained as part of the RFID tag, the UID code data is stored during shipping. Acquiring includes distributing drug delivery devices and and / or during transport of the medication holder of the medication administration device, RFID scanning is performed at each planned shipping location. In another embodiment, the authentication may involve using a UID code data. If the authentication data is contained in the form of a barcode, a barcode scanner can be used. In yet another embodiment, the authentication data as UID code data can be stored in the integrated circuit. In this case, the integrated circuit is powered and transmits the UID code data to the receiving communication interface. In yet another embodiment, the authentication data may be transmitted to the If printed with invisible ink containing UV fluorescent ink, the authentication data will be In yet another embodiment, the authentication data may be obtained using a write reading device. If the authentication data is printed with invisible ink, including infrared ink, it may be readable by infrared light. The image may be acquired using a capture device.

[0161] In a similar manner for assessing the authenticity of medication parameter data, authentication data may be combined with an acceptable Authenticity can be assessed by comparing it with possible authentication data. may be encrypted and compared by the processor to acceptable authentication data. Acceptable authentication data may be stored in the memory of an external device or the medication administration device. All of the features described in relation to medication parameter data can be independently authenticated. The data can be applied to the medication holder authentication data and the medication parameter authentication data. Both may be used, or the medication holder authentication data and the medication parameter authentication data may be used. Only one of the data can be used.

[0162] In an exemplary embodiment, a drug administration device configured to use the dosing parameters is configured to hold a medication and configured to store medication holder data. a medication holder including a data storage component attached thereto; and a first communication interface configured to receive data; a processor configured to receive medication holder data from the interface; and a second communication interface configured to receive at least a relevant subset of the parameter data; an interface; a memory configured to store medication parameters; and from the medication holder based on medication parameters established by the relevant subset of metadata. and a dispensing mechanism configured to dispense the drug from the drug holder. and obtaining a relevant subset of medication parameter data. It may be possible to ensure that the device operates at the most appropriate dosing parameters. do.

[0163] The drug administration device may be any of a variety of drug administration devices (e.g., the drug administration devices of FIGS. 1 to 3 and 5). and establishing dosing parameters for the drug delivery device described above. The method for performing the method may be configured to define any of the features described herein. .

[0164] The first communication interface and the second communication interface are data storage components. and the server, respectively. The interface and the second communication interface each include a data storage configuration The data storage component and the server are in an appropriate form for interacting with the data storage component and the server. If the server relies on the same form of communication, the first communication interface and the second communication interface The interface may be a communication interface.

[0165] The memory configured for the medication parameters may include the memory described herein. For example, ROM, flash memory, one or more types of RAM, and / or Or it may include a combination of memory technologies.

[0166] In an exemplary embodiment, a drug delivery system configured to use dosing parameters A drug administration device, the drug administration device configured to hold a drug. a medication holder and a dispensing mechanism configured to dispense the medication from the medication holder; , a medication administration device. The system also includes a medication holder associated with the medication holder. and an external device configured to acquire data from the server. a first communication configured to receive at least a relevant subset of the medication parameter data; an interface; a processor configured to receive medication holder data; and and a memory configured to store the parameters. The dispensing mechanism includes from the medication holder based on the medication parameters established by the relevant subset of data. The device is configured to dispense a medication.

[0167] The drug delivery system may include various drug delivery devices (e.g., the drug delivery devices shown in FIGS. 1-3 and 5). and establishing dosing parameters for the drug delivery device described above. The method for performing the method may be configured to define any of the features described herein. .

[0168] The external device may be a smart device, e.g., in an exemplary embodiment, a wireless protocol An external device is a device that can communicate with other devices via Whether it's a smartphone, tablet, smartwatch, or other smart device The external device may be a dedicated external device for operating as part of a drug administration system. Alternatively, the external device may act as part of a drug delivery system. may be a device that has other functions and can increase the usability of the system. If the external device is a smartphone, the system uses the user's existing smartphone. It can be used as part of

[0169] the external device includes an image sensor configured to acquire medication holder data. In this manner, the image sensor acquires image data related to the medication holder. This image data can then be analyzed to extract the necessary drug holder data. For example, the medication holder data may be in the form of an appearance of the medication holder, Therefore, the image of the medication holder allows the external device to acquire medication holder data. If the external device is a smartphone or other smart device that includes a camera function, In some cases, the image sensor may be part of a camera system of a smart device.

[0170] The memory of the external device or drug administration device may store multiple sets of medication parameters, e.g. For example, the memory may be configured to store multiple dosing regimens. A number of options can be stored that can be used to dispense the product. The relevant subset of data may be used to generate multiple sets of medication parameters to operate the dispensing mechanism. This allows the user to indicate which set of data is to be taken from the server. This reduces the amount of data that needs to be transmitted, thus increasing the efficiency of the communication process. This can be particularly useful in areas with poor communication coverage. The medication parameters in the multiple sets of data are used in accordance with the present invention for establishing medication parameters. The memory can then be updated as needed, as described in the specification. It can contain an initial set of medication parameters that can be updated.

[0171] Drug holder data includes the type of drug in the drug holder, the concentration of the drug in the drug holder, and at least one indication of the origin of the drug in the holder and the volume of the drug in the drug holder. Thus, the medication holder data may include identifying aspects of the medication within the medication holder. and thus be able to command relevant subsets of medication parameter data accordingly. For example, medication holder data indicating the type of medication in the medication holder may be included in the medication parameter data. The relevant subset of data will be the medication parameter data relevant to that drug type. The medication holder data may provide an indication of various aspects of the medication within the medication holder. This method allows for more accurate determination of dosage parameters tailored to a particular drug. It will be possible to acquire

[0172] The drug holder data can directly dictate some aspects of the dosage regimen. For example, the medication holder data may command a dose volume, and the dose volume may be determined by the medication parameter. Combine with other medication parameters established by a relevant subset of parameter data. It is possible.

[0173] An embodiment for establishing medication parameters is outlined in FIG. Object holder data is acquired (902). Optionally, medication administration data is also acquired (903). 904). After obtaining the drug holder data and, optionally, the drug administration data, the medication parameters are Metadata and, if obtained, optional medication administration associated with the medication holder data The data can be determined 906. This determination can include determining the medication parameter data as follows: Drug holder and / or drug information, such as drug type, drug concentration, and drug volume in the drug holder is medication parameter data tailored for a given aspect of the medication in the medication holder; and By drug administration data (if obtained and used), such as dose volume and administration rate It can be medication parameter data relating to the capabilities of the medication delivery device indicated.

[0174] In embodiments that include authentication data, the authentication data is always provided with counterfeit protection; For example, the processor may process the received authentication data in a lookup table of authorized codes. The drug delivery device and / or drug holder of the drug delivery device are compared with the data in the The device is included in a certified (non-counterfeit) device. code included in the lookup table) or is not included in a certified device or (a code not included in the lookup table to indicate a likely counterfeit) Associated data to help ensure authenticity is determined, such as whether It can be considered.

[0175] and establishing the medication parameters after determining the relevant subset of medication parameter data. As discussed above, the medication parameters can be stored in the medication parameter data. In other words, the medication parameter data can be expressed directly as the volume of the dose. The dosing parameters to be used, such as the frequency of doses and the time of doses, can be dictated. Alternatively, the medication parameter data can be stored as medication parameters already present on the medication delivery device. It can indicate which set of meters should be used. The meter may be stored in a memory associated with the drug administration device. Once established, the drug delivery device can be operated in accordance with the established dosing parameters. As described above, the drug delivery device and / or the drug delivery device may be In an embodiment including authentication data that specifically identifies the holder, the first state is These parameters determine the administration of the drug according to the parameters of the algorithm that defines the administration regimen. The second parameter for counterfeiting allows the drug to be administered to the drug administration device. Prevents the drug from being administered by a device.

[0176] In embodiments that include authentication data, the printed authentication data can be used to provide additional counterfeit protection. Alternatively, printed authentication data may be provided instead of electronic authentication data. It can be used to provide counterfeit protection.

[0177] The printed authentication data is printed on the medication administration device and / or on the medication holder. may include overt printed authentication data and / or on and / or may include covertly printed authentication data printed on the medication holder. In some embodiments, the printed authentication data includes overt and covert printed authentication data. .

[0178] The overt printed authentication data may be visually printed, for example, by the user using the medication administration device and and / or the medication holder, Includes data printed on the chair and / or medication holder. Overt printed authentication data The data confirms that the overt printed authentication data is present and in the expected form, e.g. For example, visually indicate that it contains expected wording, expected logo, expected brand name, etc. By verifying the authenticity of the medication administration device and / or medication holder, the user can determine The overt printed authentication data is configured to allow the expected The dosage form is included in the Instructions For Use (IFU) of the drug delivery device. The information may be provided to the user in any of a variety of ways, such as by overt printing. If the authentication data is not present and / or is not in the expected form, the user may The medication device and / or medication holder may be counterfeit and should be used It can be determined that it is not.

[0179] Covert printed authentication data is invisible to the naked eye and can be read using a light-reading device. on the medication administration device and / or on the medication holder, configured to be visible using This includes printed data. For example, covert printed authentication data is invisible to the naked eye. It is printed using ultraviolet fluorescent ink that is visible to ultraviolet fluorescent light readers. In another embodiment, the covert printed authentication data may be invisible to the eye but may be printed in red. It may be printed using infrared ink that is visible to infrared light readers.

[0180] FIG. 10 shows a processor 1002 associated with either the drug administration device or an external device. 1 is a schematic diagram of one embodiment of a data flow diagram of a drug hormone receptor. 1006, a medication holder data associated with the medication holder 1006 of the medication administration device. The data 1004 is received.

[0181] The medication parameter data 1008 associated with the server 1010 is The processor 1002 then communicates the 2. Based on the communicated medication holder data 1004, the associated sub-data of the medication parameter data Alternatively, the processor 1002 may determine a set of medication holder data. 004 can be communicated to the server 1010, and the server can determine the relevant medication parameter data. This can be done on the server 1010, and then only the relevant subset of medication parameter data can be retrieved. , can be transmitted from the server 1010 to the processor 1002.

[0182] Authentication data 1016 indicating the authenticity of the medication administration device and / or medication holder 1006 is , communicated from the medication administration device to the processor 1002.

[0183] As mentioned above, in some embodiments, the medication parameters are used instead of the authentication data 1016. In another embodiment, the medication parameters are Authentication data 1016 is provided to the processor 1002 rather than the authentication data 1008. In yet another embodiment, the authentication data 1016 and the medication parameter data 1008 are stored in a The signal is provided to the processor 1002.

[0184] Medication administration device data 1012 is also processed from the medication administration device or an external device. The medication administration device data 1012 can then be communicated to the processor 1002. On the device 1002, the relevant medication parameter data may be used to determine the medication administration. Device data 1012 includes information about the associated medication parameter data determined on server 1010. If so, the processor 1002 may transmit the data to the server 1010. The device 1002 receives relevant medication parameter data from the server 1010 or from a local and utilizing the relevant medication parameter data to control the dispensing mechanism 1 of the medication delivery device. Control 014.

[0185] FIG. 11 shows a list of medication holder data and / or authentication data that can be used to obtain the medication holder data and / or authentication data. 10 depicts one embodiment of a drug delivery device 1006 having: It includes a medication holder 1102 that includes a data storage component 1104 in the form of an RFID tag. The medication administration device 1106 also includes a communication interface 1106 in the form of an RFID scanner. When the medication holder 1102 is in place within the medication administration device 1106, The scanner 1108 may also include a data storage component 1104 for storing medication holder data and / or may receive authentication data. The received medication holder data and / or Alternatively, the authentication data may be stored in the medication administration device 1106 or an external device, as described herein. The data may be communicated to any processor in the system.

[0186] FIG. 12 shows a list of medication holder data and / or authentication data that can be used to obtain the medication holder data and / or authentication data. 1 illustrates an embodiment of a drug delivery system that includes a smart device. An external device in the form of 1202, in this illustrated embodiment, comprises a smartphone. The smart device 1202 includes an image sensor 1204, e.g., The image sensor 1204 is configured to capture an image of the medication holder 1206. The smart device 1202, for example, The image of the object holder 1206 is analyzed to obtain the object holder data and / or authentication data. The medication holder data and / or authentication data can be stored in the smart device 12. 02 communicates with an external server and uses the medication holder data to store the associated medication parameters on the server. Determining the metadata and / or determining the authenticity of the medication holder 1206 or to store the medication holder data and / or authentication data on the smart device 12. Utilizing the medication holder data by the processor of 02, the associated medication parameters The data can be used to determine the authenticity of the medication holder 1206. In a similar manner, the smart device 1202 can image the medication administration device 1208. The medication delivery device 1208 can be configured to receive the medication holder 1206. and therefore configured to obtain medication administration device data and / or authentication data. This drug delivery device data is then used to determine relevant medication parameter data. and / or use this authentication data to The authenticity of 1208 can be determined.

[0187] Ensuring component compatibility Generally, establishing compatibility of components is important because it determines whether the components are compatible with drug administration in a particular situation. related to determining whether a device has been previously determined to be suitable for use with the given device. Establishing compatibility ensures that the drug administration device can function properly to deliver the drug to the patient. and / or are not compatible with and are used with medication delivery devices. Patient injury or death from use of a drug delivery device containing components that should not be used or otherwise help ensure that you are not harmed.

[0188] In an exemplary embodiment, a method for establishing compatibility of components of a drug administration device includes: obtaining first component data associated with a first component of the dispensing device; comparing the first component data with acceptable first component data; and determining whether the drug delivery device is functioning properly based on a comparison of the element data with the acceptable first component data. and setting the operating state.

[0189] A method for establishing compatibility of components of a drug delivery device is to determine whether the correct first component is compatible with the drug. This can ensure that the drug is used with the drug administration device. may result in the incorrect administration of a drug, which may be dangerous to the patient receiving the drug. This may reduce the risk of inadvertently using unsuitable components that may be unsuitable for the purpose. An example of an element is a drug in a drug holder that is not compatible for use with a drug administration device.

[0190] The method can establish the compatibility of a single component of a drug administration device or This allows for compatibility of multiple components of a drug delivery device. Examples of components that can be attached include a medication holder, a medication in the medication holder, a syringe tie, and a syringe. needle type (for drug administration devices that include a syringe), needle type (for drug administration devices that include a needle), Catheter type (for drug administration devices including catheters), and sensor type (for sensors (for drug administration devices including

[0191] Obtaining the first component data includes extracting the first component data from the component to an external device. Alternatively, obtaining the first component data may include communicating the first component data to the device. The first component data is transferred from the component to another component, such as a processor of a medication administration device. The processor may communicate the first component data to the first acceptable first used for comparison with component data and to set the operating state of the drug delivery device. The processor may be the same as that used in the It is also possible.

[0192] Communicating the first component data includes communicating the first component data to a data storage component. The first component may include a data storage component. As discussed, examples of data storage components include integrated circuits, RFID tags, and barcodes. The first component data may be stored in a single data storage component or in multiple data storage components. When multiple data storage components are used, each is This may vary depending on the type of data communication, such as if a particular type of data communication is not currently available. For example, providing redundancy even if an RFID scanner is missing or damaged. It may be useful to provide and / or enable retrieval of first component data. As discussed above, data (e.g., first component data) may be retrieved from the data storage component. Acquiring the data may involve the use of a device such as an RFID scanner, a barcode scanner, or an integrated circuit. a suitable communication interface for receiving medication holder data communicated from the medication holder; Requires the use of a system where component compatibility is established and dosing parameters are established. and the data storage component containing the first component data is a data storage component. or an implementation having the same form as the data storage component for storing medication holder data. In this configuration, the same reader can be used to obtain both sets of data. do.

[0193] The details described herein regarding the first component and first component data may be and the component data for each of these components. Various forms of component data storage and retrieval means may be used in combination as desired. This can be done.

[0194] Comparing the first component data to the acceptable first component data The processor may be part of the drug administration device or may be an external device. The acceptable first component data may be stored in a memory. The memory may be part of the drug administration device or may be part of an external device. If the processor is part of a medication administration device, it may communicate with off-board memory. Preferably, the memory is also part of the drug administration device to avoid the need for Similarly, if the processor is part of an external device, it may need to communicate with off-board memory. To avoid this, it is preferable that the memory is also part of the external device.

[0195] Comparing the first component data to the acceptable first component data includes: A first component parameter of the component data is compared with an acceptable first component data tolerance. This comparison may include comparing the dosage parameters with acceptable parameters. The comparison may occur in a manner similar to that discussed above with respect to the comparison with the dosing parameters. Each of the first component parameters in the component data is an acceptable first component data. The method may include determining whether the parameter matches a corresponding parameter in the data, where the match indicates compatibility. indicates that there is a mismatch, and a mismatch indicates an incompatibility.

[0196] The allowable first component data may be updatable. The compatibility of a drug delivery device with a component is determined by the components and the drug delivery device. The drug delivery device may be updated based on developments. and storing updated acceptable first component data in a memory. The communication interface may include a communication interface configured to:

[0197] As described above, setting the operational state of the medication administration device includes first component data Setting the operational state may be based on a comparison of the first component data to acceptable first component data. If the first component data is determined to correspond to acceptable first component data, maintaining an operational state of the medication administration device. If it is determined that the possible first component data does not correspond, the operating state of the medication administration device from a drug administration device operating for drug delivery; Not be modified into a drug administration device (or already configured to not work for drug delivery) (If the device is in use, it may remain inoperative for drug delivery.) Alternatively, The operational state of the given device is such that the first component data is in accordance with the acceptable first component data. If so determined, the drug administration device may be operable to deliver the drug. may be modified into a drug administration device operating for drug delivery (or If already set to do so, it may remain operational for drug delivery. The default operating state of the drug delivery device is in an operating state or drug delivery is not possible. , but comparing the first component data to acceptable first component data; providing a user notification on the user interface of the medication administration device; Other actions may be possible, depending on whether the action is prohibited. For example, the default operating state may be, for example, An operating state where administration is prevented but other operations are possible, i.e., a prohibited operating state indicates that the first component data corresponds to the allowable first component data and is accessible. Any other component data that may be included (e.g., second component data for the second component) data for a third component, third component data for a third component, etc.) are included in the If it is determined to correspond to the data, it may be changed to an operational state.

[0198] Obtaining the first component data may be performed on an external device. External devices utilized as part of the raw data comparison are part of establishing medication parameters. This may be the same external device used as the

[0199] As discussed above, the external device may be a smart device. The device is a device dedicated to the function of establishing compatibility of components of a drug administration device. Alternatively, the external device may be a smartphone, tablet, smartwatch, etc. This multi-functional capability allows for the device to perform other functions such as drug delivery. Device users should consult existing device documentation to establish compatibility of medication delivery device components. This allows compatibility checks to occur appropriately and without delay. This may increase the risk of users using such external devices for fast access. This is because it is already customary to keep the device on or otherwise close to the user's person.

[0200] Comparing the first component data to acceptable first component data may be performed using external data. This may occur on the device, particularly when the external device acquires the first component data. It can be efficient.

[0201] Comparing the first component data to acceptable first component data may The processor of the given device, for example, a processor that is part of the first component, may be utilized. Using the processor of the medication administration device, the first component may when acceptable first component data is received from another source, such as another component of the This can be particularly efficient when the first component receives acceptable first component data. In one embodiment, the first component performs the comparison on a processor and, if necessary, determines The determined compatibility may be determined, for example, by communicating the compatibility determination to a processor of the medication administration device. Thus, the first configuration is configured to communicate with the remaining medication administration devices. Based on the compatibility of the elements, it may be possible to control the operability of the drug administration device.

[0202] The first component data may include image data. The image data may be stored in an external The above-discussed drug administration device may be imaged using a Thus, the external device may include an image sensor, which may be a camera or a smart device. The first component data may be in the form of other image acquisition elements of the device. By using the data, users can easily evaluate the compatibility of components with drugs. An image of the dispensing device can be taken. Taking an image is a convenient way for many users to This approach is therefore preferred by most users. would not be considered bothersome.

[0203] If the first component data includes image data, the first component data and the allowable The comparison with the component data of one may be performed using specific markers representing one or more specific components. For example, evaluating the image data may include evaluating the pattern. The processor extracts specific markers or patterns on the exterior surface of each of the components, which are then compared to each other. This may include evaluating whether the component is a compatible component. the drug administration device or in a manner that allows for data acquisition of the marker or pattern of the Individual components can be commanded to be imaged. To assist in this, markers or patterns can be used. The data for the line is stored in multiple locations on the drug delivery device and / or various components of interest. It can exist.

[0204] Obtaining the first component data includes obtaining the first component data from the first component. This may include communicating to a processor of the medication administration device.

[0205] Setting the operational state of the medication administration device includes determining whether the first component data is acceptable. If the component data corresponds to 1, the operational status should be fully operational. and determining whether the first component data corresponds to the acceptable first component data. If not, flagging the operational state as not being at full capacity. The flagging of the operational state is based on the first component data and the acceptable first component data. Based on the comparison with the data, the operating condition should be full (or data indicating that the drug should not be administered to a patient in a memory, e.g., a drug administration device or an external device, This may include writing the necessary data to the memory of the component when evaluating its compatibility. This flag data can be read accordingly.

[0206] The flagging associated with the first component data is whether certain criteria are met. Each is configured to indicate whether the operational state should be at full capacity, based on the This can be incorporated into a broader approach with multiple flags defined. For example, one or may associate two or more additional flags with the compatibility of components other than the first component. In this way, setting the operating state of the drug administration device is possible. The flags (the flag for the first component and one or more additional flags) indicate the operational state. Set the operational state as fully operational when it indicates that the and either a flag for the first component and one or two If the above additional flags indicate that the operating state should not be at full capacity, This may include setting the status as not fully operational. The approach allows the operating state to be set based on a range of different criteria, thus Whether the drug administration device should be activated or deactivated for drug delivery. It effectively acts as a checklist when needed to assess whether a patient is taking a medication. Setting the operational state of the device may involve one or more additional components of interest. whereas, if the first component data corresponds to acceptable first component data; and The second component data is only active if it corresponds to acceptable second component data, etc. This may include flagging the operating state as being at full capacity for drug delivery. .

[0207] A flag is used to determine whether the drug administration device should be fully operational for drug delivery. The presence of a flag indicates that a drug When setting various variable parameters of the administration device, e.g., as defined by the dosing regimen, This information may be used in setting variable parameters of the medication algorithm being administered. Taking into account the flags present, the operational state can be set appropriately. These flags are written in the form of data (called "flag data") in memory. This flag data may then be used to determine whether the medication administration device is fully operational. It can be read for use in assessing whether or not

[0208] In an exemplary embodiment, the first component is configured to be removable and replaceable. For example, the first component may be a drug delivery device. The holder is configured to be removably and replaceably received by the medication administration device. The drug holder of the drug administration device may be used in combination with the drug holder. The ability to check the medication holder ensures that the medication holder is suitable for use with the medication administration device. Ensuring that the medication holder is suitable for use with the medication administration device is important. Incorrect medication, incorrect drug concentrations, and incorrect dosage forms can all be inadvertently dispensed along with the medication delivery device. This can help ensure that the device is not in use, thereby improving patient safety and outcomes. The compatibility check of the medication holder can be performed based on the medication parameters described herein. In particular, drug holder data can be used as part of the process of establishing compatibility. It can be used as at least part of the first component data used in the evaluation.

[0209] If the first component data is associated with a medication holder, the first component data is the type of drug in the container, the origin of the drug, the concentration of the drug in the container, the expiration date of the drug, and The first component may include at least one indication of the volume of the medication in the medication holder. The raw data can indicate whether the medication holder is compatible with the medication administration device. .

[0210] If the first component data relates to a feature of the first component itself, Comparison of the data with acceptable first component data is based on known acceptable data for the first component. For example, the first component data may be the type of medication in the medication holder. The first component data and the acceptable first component data can be transmitted. The comparison may be performed by comparing the type of medication in the medication holder with a device (e.g., a device with access to a processor that performs the comparison). a known number of medication delivery devices (as shown in a look-up table stored in a memory) comparing the drug to acceptable drug types and, accordingly, operating the drug administration device accordingly. It may be possible to set the state.

[0211] The first component data may include an indication of a compatible drug delivery mechanism parameter. In this way, the first component data indicates that one or more forms of drug delivery mechanism are Therefore, the first component The data conveys acceptable forms of drug delivery mechanisms that may be used with the first component. It is possible.

[0212] The first component can include a dispensing mechanism, and the first component data can include a drug dispensing mechanism. In this way, the first component can include an indicator of one or more capabilities of the structure. The evaluation of the compatibility of the raw data with the acceptable first component data is one of the drug delivery mechanisms. or two or more capabilities may be used with other components of the drug administration device, e.g., a drug holder. The criteria may be based on whether the product is acceptable for the purpose.

[0213] The first component data may include an indication of a compatible medication holder parameter. In this manner, the first component data may be used to identify a medication holder that may be used with the medication administration device. The type of

[0214] The first component data may be encoded on the first component. The component data may reside on the first component. This encoding on the first component is , ensuring that the first component has readily accessible first component data and the first component data is separated from the first component and therefore the first structure The risk of the components becoming unavailable for access to evaluate their compatibility with drug delivery devices. This can reduce the risk.

[0215] In an exemplary embodiment where compatibility of components of a drug administration device is established, The device is configured to hold a housing and a drug and at least partially a medication holder within the housing and configured to dispense the medication, and a distribution mechanism both partially within the housing and configured to store first component data. and a data storage device configured to receive the first component data and generate an acceptable first component. and configuring the medication administration device to operate in a manner consistent with the raw data based on the comparison. and a processor configured to

[0216] In another exemplary embodiment where compatibility of components of a drug administration device is established, The drug delivery system includes a drug delivery device, the drug delivery device including a housing, a drug holder, and a a medication holder configured to receive the medication and at least partially within the housing; and and a dispenser configured to dispense the drug and at least partially within the housing. The drug delivery system also includes a delivery mechanism associated with the first component of the drug delivery device. an external device configured to acquire the first component data; , receiving first component data and comparing it with acceptable first component data; and a processor configured to set an operational state of the medication administration device based on the measured value.

[0217] These two exemplary embodiments of the drug delivery device and drug delivery system allow Based on the component data of 1, the compatibility of the components is evaluated and the The operating state of the drug administration device can then be set accordingly.

[0218] FIG. 13 illustrates, in a simplified manner, one embodiment of a method for establishing component compatibility. First component data is obtained 1302, as described herein. The obtaining may be, for example, when the first component data is communicated from a data storage component; or An image is taken of a first component, and first component data is extracted from the image data. This can occur by:

[0219] The first component data is then compared to acceptable first component data (1 304). As described herein, this comparison may be performed by a processor, e.g., a drug administration device. This can be done using a processor in the device or an external device. The element data may be stored in a memory associated with the processor, and the processor The acquired first component data is compared with the acceptable first component data present in the memory. can be compared with the data.

[0220] Based on the comparison, the processor determines whether the first component data is in an acceptable first configuration. It is determined 1306 whether the first component data corresponds to the element data. In the situation where it is determined (1306) that the first possible component data corresponds to the first possible component data, the processor indicates that the drug delivery operation of the drug administration device can proceed as needed. The drug administration device for drug delivery may be configured to The drug delivery device then enables operation of the device (1308). The first component data may be configured to check the status of the flag before the first component data is accepted. If it is determined 1306 that the first component data does not correspond to the drug, the processor and data indicating that the drug delivery operation of the drug administration device can proceed as required. A flag is written as part of the drug delivery operation of the drug administration device to progress as needed. Instead of writing a flag as part of the data indicating that the drug cannot be The drug delivery device may be disabled, such as by removing an existing flag indicating that the delivery device is operational. Prevent operation of the dispensing device (1310).

[0221] As discussed above, operation of the drug administration device for drug delivery involves the drug administration device Device operations that may be controlled by, for example, a processor of a medication administration device Therefore, the device operation prevention mechanism is not included in the compatibility evaluation. Thus, the drug may be in a locked state (preventing drug delivery) or an unlocked state (enabling drug delivery). ) can be placed in

[0222] FIG. 14 shows the first component data associated with the first component. 1 illustrates an embodiment of a drug delivery device that can The component is a medication holder 1402 of a medication administration device, and the first component data is It exists as an RFID tag 1404 attached to a medication holder 1402. The cannula 1406 is part of the housing 1408 of the medication delivery device and is attached to the medication holder 1408. 402 interacts with RFID tag 1404 when present within housing 1408. In this way, the scanner 1406 is positioned so that the medication holder 1 The first component data can be obtained from 402. Then, The data may be transmitted to a processor (of the drug administration device or an external device), where: The first component data may be acceptable first component data as discussed herein. The processor then performs a calculation based on this comparison, as also discussed herein. Based on the detected drug dose, an operational state of the drug administration device for drug delivery is set.

[0223] FIG. 15 illustrates one embodiment of a drug delivery system including an external device. In this embodiment, the device is a smart device configured to wirelessly interact with other components. The external device 1502 receives the first configuration in the form of image data. The image sensor 1504 is associated with the image sensor 1504 configured to acquire component data. The image sensor 1504 is mounted on the smart device 15 as shown in one alternative in FIG. Alternatively, as shown in another alternative in FIG. 504 may reside on another external device, such as glasses 1506, which may be worn by the user. obtain.

[0224] The image sensor 1504 is used to image a range of components associated with the medication administration device. Acquire image data and then verify that all imaged components are correct The imaged component may be a syringe 1508 of the first drug administration device. , a catheter 1510 of the first drug administration device, a needle 1512 of the first drug administration device , a sensor 1514 (e.g., a glucose sensor) associated with the first medication administration device. ), each configured to be inserted into a housing 1518 of a second medication administration device. The medication holder 1516 and the housing 1518 of the second medication administration device It may include one or more of the following:

[0225] As described herein, establishing component compatibility allows for the drug delivery device The results of the evaluation can be used to determine whether the components are suitable for forming the device. Use of indicators and / or user interfaces to communicate warnings to users The warning may be a visual warning on a screen associated with the medication administration device. The warning may be a warning if there is a compatibility issue and therefore the administration The components are compatible and the project is not ready for execution, compared to a warning that indicates the project cannot proceed. Alternatively, a warning may simply be an indication that the application can proceed. It may only be issued if compatibility is an issue or if no compatibility issues have been identified.

[0226] If the drug administration device has stored medication parameter data, component compatibility is Establishing compatibility can ensure compatibility with medication parameter data. If the administering device has medication parameter data indicating the daily frequency of drug administration, Establishing component compatibility is key to determining whether components are compatible with the daily dosing regimen. The medication parameter data may be transmitted from the drug administration device or an external device. The first component data or other component data may be stored in the memory of the The comparison of whether a given dosing regimen is suitable can be performed by a processor.

[0227] In addition to evaluating component compatibility, it is also important to ensure that only compatible devices are utilized. Other approaches can be used to ensure consistency between components. The physical interface is designed to include components that are known to be compatible. It can be sized and shaped to limit interchangeability. Limiting the number of components that can be connected to form a drug delivery device and This reduces the likelihood of incompatible components being utilized.

[0228] All of the devices and systems disclosed herein are designed to be disposed of after a single use. It may be designed to be used multiple times, or may be designed to be used multiple times. However, the device can be reconditioned for reuse after at least one use. Maintenance involves the steps of disassembling the device, followed by cleaning or replacing specific parts, and then This may include any combination of reassembly steps. Specifically, the device may be disassembled. and the ability to selectively replace any number of the particular pieces or portions of the device in any combination. When certain parts are cleaned and / or replaced, they can be removed for subsequent use. The device is reconditioned either at the facility for surgical intervention or by the surgical team immediately prior to surgery. Those skilled in the art will understand that reconditioning of a device requires minimal effort, including disassembly, cleaning / replacement, and reassembly. It will be appreciated that a variety of techniques for assembly and reassembly may be utilized. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application. do.

[0229] It may be preferable that the devices disclosed herein be sterilized before use. Examples of suitable methods include beta or gamma radiation, ethylene oxide, steam, and liquid baths (e.g., cold immersion). This can be done by any number of known methods. A typical embodiment is described in "System and Met" published on August 13, 2009. hod Of Sterilizing An Implantable Medica More details are provided in U.S. Patent Publication No. 2009 / 0202387, entitled "An Integrated Circuit Device." It is preferred that the device be completely sealed when implanted. , can be done by any number of methods known to those of skill in the art.

[0230] The present disclosure is described through the examples only within the context of the entire disclosure provided herein. Within the spirit and scope of the claims appended hereto without departing from the overall scope of this disclosure. It will be understood that modifications may be made.

Claims

1. 1. A method for establishing dosing parameters for a drug delivery device, said method comprising: obtaining drug holder data from a drug holder of the drug administration device; and communicating the data to a processor, wherein the medication administration device comprises a processor. or an external device comprises said processor. and, and communicating at least a relevant subset of medication parameter data from a server to said processor. To do, Using the processor, establishing the dosing parameters of the medication delivery device; determining a relevant subset of the medication parameter data based on the medication holder data; The way it is done.

2. communicating the medication holder data from the processor to the server; determining a relevant subset of the medication parameter data on the server; Including, a method.

3. further comprising communicating medication administration device data from the processor to the server; The relevant subset of medication parameter data includes the medication holder data and the medication administration The method of claim 2 , wherein the determination is based on both device data and the associated device data.

4. After said communication, said processor is used to obtain a relevant subset of said medication parameter data. determining a The communicating step includes communicating the relevant subset of medication parameter data and the medication parameter data.

10. The method of claim 1, further comprising communicating medication parameter data including a non-associated subset of data. The method described below.

5. The relevant subset of medication parameter data includes the medication holder data and the medication administration data. The method of claim 4 wherein the determination is based on both the given device data and the given device data.

6. The medication administration device data may be used to configure the medication administration device in at least one other form.

6. The method according to claim 3 or 5, which is distinguished from the drug administration device of claim 1.

7. 10. The method of claim 1, wherein the communication between the processor and the server comprises encrypted communication. The method according to any one of claims 1 to 6.

8. 10. The method of claim 1, wherein the communication between the medication holder and the processor comprises encrypted communication.

8. The method according to any one of claims 1 to 7.

9. Storing the medication parameters in a memory of the drug administration device. Item 9. The method according to any one of items 1 to 8.

10. Storing the medication parameters in a memory includes:

10. The method of claim 9, including updating a meter.

11. The relevant subset of medication parameter data is one of a plurality of sets of medication parameters. The method according to any one of claims 1 to 10, further comprising indicating which set of the following to adopt.

12. The drug is infliximab, golimumab, ustekinumab, daratumumab, Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate The composition according to any one of claims 1 to 11, comprising at least one of the following: method.

13. 1. A method of operating a drug administration device, said method comprising: Establishing the dosing parameters of a drug administration device according to any one of claims 1 to 12 And, assessing the suitability of said dosing parameters; Preventing the dispensing of the drug if the dosing parameters are not met; and If the dosing parameters are met, dispense the drug based on the dosing parameters. A method comprising:

14. Evaluating the suitability of the dosing parameters may include adjusting the dosing parameters to the drug comparing the dosage parameters with acceptable dosage parameters stored in the memory of the administration device. The method according to claim 13.

15. and determining whether the authentication data associated with the medication parameter data is a valid medication parameter. evaluating the authenticity of said medication parameter data by comparing it with authentication data; 15. The method of claim 13 or 14, further comprising:

16. and converting authentication data associated with the medication holder data into acceptable medication holder authentication data. and evaluating the authenticity of the medication holder data by comparing the medication holder data with the medication holder data. The method according to any one of claims 13 to 15.

17. comparing authentication data associated with the medication holder with acceptable medication holder authentication data; The method according to claim 13, further comprising evaluating the authenticity of the medication holder by comparing the 17. The method of any one of claims 16 to 16.

18. and converting authentication data associated with the medication administration device into an acceptable medication administration device authentication data. and further evaluating the authenticity of the medication delivery device by comparing the authenticity data with the The method according to any one of claims 13 to 17, comprising:

19. The drug is infliximab, golimumab, ustekinumab, daratumumab, Coumab, epoetin alfa, risperidone, and esketamine, ketamine, palmitate The method according to any one of claims 13 to 18, comprising at least one of the following: How to do it.

20. 1. A drug administration device comprising: A medication holder configured to hold a medication, the medication holder comprising: a medication holder comprising a data storage component configured to store data; a first device configured to receive the medication holder data from the data storage component; a communication interface; configured to receive the medication holder data from the first communication interface. a processor; configured to receive at least a relevant subset of medication parameter data from the server; a second communication interface; a memory configured to store medication parameters; to the medication parameters established by the relevant subset of medication parameter data. a dispensing mechanism configured to dispense the medication from the medication holder based on the A drug delivery device.

21. 1. A drug delivery system comprising:

1. A drug administration device, comprising: a medication holder configured to hold a medication; and a dispensing mechanism configured to dispense the medication from the medication holder. a dosing device; an external device, the external device being configured to receive a medication holder associated with the medication holder; and configured to acquire folder data, wherein the external device: configured to receive at least a relevant subset of medication parameter data from the server. a first communication interface; a processor configured to receive the medication holder data; and an external device comprising: a memory configured to store medication parameters; Preparation, The dispensing mechanism selects a medication dose based on the associated subset of medication parameter data. configured to dispense the medication from the medication holder based on a parameter; Drug administration system.

22. a data storage arrangement, wherein the medication holder is configured to store the medication holder data; a second element, the external device being configured to receive the medication holder data; 22. The system of claim 21, comprising two communication interfaces.

23. the external device includes an image sensor configured to acquire the medication holder data; The system of claim 21 comprising:

24. The processor determines the relationship of the medication parameter data based on the medication holder data. The device of claim 20, configured to determine a contiguous subset. Item 24. The system according to any one of items 21 to 23.

25. the memory is configured to store a plurality of sets of medication parameters; The relevant subset of medication parameter data is used to operate the dispensing mechanism.

20. A method for determining which of a plurality of sets of medication parameters is to be employed. or a device according to claim 24, or a system according to any one of claims 21 to 24.

26. 25. The method of claim 20, wherein the memory is configured to store authentication data. A device according to claim 21 or a system according to any one of claims 21 to 24.

27. The dosing parameters include the volume of drug dispensed, the frequency of drug dispense, the rate of drug dispense, and and the time at which the drug is dispensed. The method according to claim 20 or any one of claims 24 to 26, or the device according to claim 20 The system according to any one of claims 21 to 26.

28. The medication holder data includes the type of medication in the medication holder, the medication in the medication holder, the concentration of the drug, the origin of the drug in the drug holder, and the volume of the drug in the drug holder.

27. The method of any one of claims 1 to 19 or 26, comprising at least one indicator. A device according to any one of claims 20 or 24 to 26, or claims 21 to 26 10. The system according to claim 9, wherein:

29. The drug is infliximab, golimumab, ustekinumab, daratumumab, Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate 28. The method of claim 26 or 27, comprising at least one of the following: paliperidone acid; A device according to any one of claims 20 and 24 to 27 or any one of claims 21 to 27 2. The system according to claim 1 .

30. 1. A method for establishing compatibility of components of a drug administration device, said method comprising: obtaining first component data associated with a first component of the medication administration device; And, comparing the first component data to acceptable first component data; based on the comparison of the first component data to acceptable first component data. and setting an operational state of the medication administration device.

31. Obtaining the first component data includes:

31. The method of claim 30, comprising communicating from the component to an external device.

32. 31. The method of claim 30, wherein the acquiring of the first component data occurs on an external device. The method described below.

33. Comparing the first component data with acceptable first component data 33. The method of claim 31 or 32, which occurs on the external device.

34. Comparing the first component data with acceptable first component data 33. The method according to any one of claims 30 to 32, wherein the method utilizes a processor of the drug administration device. method.

35. 35. The method of claim 34, wherein the first component comprises the processor.

36. The first component data includes image data, and the first component data is obtained by and imaging the medication administration device using the external device. Any one of claims 31, 32, or 33, or any of claims 31, 32, or 33 36. A method according to claim 34 or 35 when dependent on any one of the claims.

37. Obtaining the first component data includes:

31. The method of claim 30, further comprising communicating from a component to a processor of the medication administration device. How to post.

38. 38. The method of claim 37, wherein the first component comprises the processor.

39. Comparing the first component data with acceptable first component data 39. A method according to claim 37 or 38, utilising said processor.

40. setting the operational state of the medication administration device If the first component data corresponds to acceptable first component data, Flagging the operational state as being fully operational; and If the first component data does not correspond to acceptable first component data, flagging the operational state as not being fully operational; or If all necessary flags indicate that the operational state should be fully operational, setting the operational state as fully operational; and If any required flags indicate that the operational state should not be fully operational, , setting the operational state as completely inoperative. The method according to any one of claims 30 to 39.

41. 4. The method of claim 3, wherein the first component is a medication holder configured to hold a medication.

41. The method of any one of claims 0 to 40.

42. The first component data includes the type of drug in the drug holder, the origin of the drug, the concentration of the drug in the drug holder, the expiration date of the drug, and the volume of the drug in the drug holder; 42. The method of claim 41, comprising at least one indicator of:

43. wherein the first component data includes an indication of a compatible drug delivery mechanism parameter.

43. The method according to claim 41 or 42.

44. 41. The device according to any one of claims 30 to 40, wherein the first component comprises a drug dispensing mechanism. How to post.

45. 45. The method of claim 44, wherein the first component data includes an indication of a performance of the drug delivery mechanism. How to post.

46. the first component data includes an indication of a compatible medication holder parameter. Item 46. The method according to item 44 or 45.

47. Claims 30-4, wherein the first component data is encoded on the first component.

7. The method according to any one of claims 6 to 6.

48. The drug is infliximab, golimumab, ustekinumab, daratumumab, Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate 48. The method according to any one of claims 30 to 47, comprising at least one of the following: How to do it.

49. 1. A drug administration device comprising: Housing and 1. A medication holder configured to hold a medication, said medication holder comprising at least a medication holder partially within the housing; and a dispensing mechanism configured to dispense the drug, the dispensing mechanism comprising at least a dispensing mechanism partially within the housing; a data store configured to store first component data; receiving the first component data and converting the first component data into an acceptable first and setting an operational state of the medication delivery device based on the comparison. and a processor configured to determine

50. 1. A drug delivery system comprising:

1. A drug administration device, comprising: housing, 1. A medication holder configured to hold a medication, said medication holder comprising at least a medication holder also partially within the housing; and a dispensing mechanism configured to dispense the drug, the dispensing mechanism comprising at least a medication delivery device comprising a dispensing mechanism, the dispensing mechanism being also partially within the housing; an external device, the external device being a first component of the drug administration device; and the external device is configured to acquire first component data relating to , receiving the first component data and classifying the first component data into an acceptable first and setting an operational state of the medication delivery device based on the comparison. and an external device comprising a processor configured to determine Tem.

51. The external device includes an image sensor configured to image the medication administration device.

51. The method of claim 50, further comprising: Grant system.

52. The medication administration device includes a data storage device configured to store the first component data.

51. The medication administration system of claim 50, further comprising a data storage device.

53. 50. The medication of claim 49, wherein the data storage device is attached to the medication holder.

52. A drug delivery device or a drug delivery system as described in claim 51.

54. The first component data includes the type of drug in the drug holder, the origin of the drug, the concentration of the drug in the drug holder, the expiration date of the drug, and the volume of the drug in the drug holder; 50. The drug administration device of claim 49 or claim 49, comprising at least one indicator of 54. A drug administration system according to any one of claims 50 to 53.

55. the data storage device is associated with the housing or the drug dispensing mechanism; 51. A drug administration device according to claim 49 or a drug administration system according to claim 50.

56. 56. The method of claim 55, wherein the first component data includes an indication of a performance of the drug delivery mechanism.

27. The drug administration device or drug administration system of claim 26.

57. the first component data includes an indication of a compatible medication holder parameter. Item 55 or 56. A drug administration device according to item 55 or 56, or a drug according to item 55 or 56. Material administration system.

58. 49 and 5, wherein the medication holder is removable from the medication administration device.

57. A drug administration device according to any one of claims 2 to 57, or any one of claims 50 to 57. Item 1. A drug administration system according to item 1.

59. The drug is infliximab, golimumab, ustekinumab, daratumumab, Coumab, epoetin alfa, risperidone, esketamine, ketamine, and palmitate Any one of claims 49 and 53 to 58, comprising at least one of paliperidone and paliperidone. or a drug administration device according to any one of claims 50 to 53 and 55 to 58. Drug delivery system.

Images