Remote aggregation of data from drug administration devices

Abstract

Generally, methods, systems, and devices are provided for remote aggregation of data from a medication administration device. In one exemplary embodiment, data indicative of information sensed by sensors of a medication administration device can be wirelessly transmitted from the medication administration device to a server. The server can use this data to: correlate a patient's medication use with the patient's clinical outcomes; perform cost analysis of patient treatment; determine whether the medication was delivered to the patient in compliance with the patient's treatment plan; identify failures in the administration of the medication; determine that additional data from the medication administration device is needed and trigger a request for this additional data to be wirelessly transmitted from the server to the medication administration device; and / or predictively model the patient's clinical outcomes.

Description

Technical Field

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

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

[0003] Regarding how to administer the drug to the patient, there are various dosage forms that can be used. For example, these dosage forms can include one or more of the drug in parenteral, inhalation, oral, ophthalmic, nasal, topical and suppository forms.

[0004] These dosage forms can be administered directly to the patient via a drug administration device.There are many different types of drug administration devices that are commonly used to deliver various dosage forms, including: syringes, injection devices (e.g., autoinjectors, jet injectors, and infusion pumps), nasal spray devices, and inhalers.

[0005] It is desirable to monitor compliance with guidelines related to the administration of drugs in various dosage forms to patients. This ensures that correct procedures are followed and that incorrect and potentially dangerous methods are avoided. Additionally, this allows for optimization of drug administration to patients.

[0006] However, it can be difficult to determine whether a drug is correctly administered to a patient via a drug administration device and to monitor compliance. The burden of detecting and reporting correct drug administration often falls on the patient, which can burden the patient with the task of administration and / or may not be reported correctly or promptly to a medical professional who can address incorrect drug administration in a timely manner. Similarly, the burden of tracking and reporting compliance with guidelines provided to patients by a physician or healthcare provider often falls on the patient. Patients may feel uncomfortable reporting behavior that does not comply with guidelines, resulting in inaccurate data being reported to and considered by medical professionals, which can adversely affect the patient's overall treatment. Summary of the Invention

[0007] In one aspect, a drug administration system is provided herein. In one embodiment, the system includes a drug administration device configured to deliver at least one dose of a drug from the drug administration device to a patient. The drug administration device includes a sensor configured to sense information related to at least one of the drug administration device and the drug. The drug administration device includes a communication interface configured to wirelessly transmit data indicative of the sensed information. The system also includes a server including a communication interface configured to wirelessly receive the data transmitted by the communication interface of the drug administration device. The server also includes a processor configured to use the data in at least one of: correlating the patient's use of the drug with the patient's clinical outcomes; performing a cost analysis that includes comparing the patient's clinical outcomes with the clinical outcomes of other patients who received a different drug than the drug delivered to the patient; comparing side effects experienced by the patient with side effects experienced by other patients who received a different drug than the drug delivered to the patient; determining whether the drug was delivered to the patient in compliance with the patient's treatment plan; identifying a failure in the administration of the drug; determining that additional data is needed from the drug administration device and triggering a request for the additional data to be wirelessly transmitted from the communication interface of the server to the communication interface of the drug administration device; and predictive modeling of the patient's clinical outcomes.

[0008] The drug administration system can have any number of variations.For example, the drug administration device can include one of a syringe, a syringe, an inhaler, a nasal spray device, and an infusion pump.

[0009] For another example, the processor may be configured to use the data in at least correlating the patient's use of the drug with the patient's clinical outcomes, and the processor may be configured to compare the correlation between the patient's use of the drug and the patient's clinical outcomes in performing at least one of the following: identifying trends in patient outcomes among multiple patients, including the patient, who have received the drug, and monitoring side effects of the drug on multiple patients, including the patient, who have received the drug.

[0010] For another example, the processor may be configured to use the data in at least performing the cost analysis, and the processor may be further configured to identify a second drug that has a lower cost than the drug and is associated with a clinical outcome that is substantially the same as the clinical outcome for the patient.

[0011] For another example, the processor may be configured to use the data in at least determining whether the medication was delivered to the patient in compliance with the patient's treatment plan, and the processor may be configured to use the determination in performing at least one of: generating an alert to a physician indicating the patient's compliance; determining a trend in the patient's compliance; determining a trend in treatment plan compliance in a specific population group that includes the patient and multiple additional patients, each patient in the specific population group sharing a common attribute including at least one of age, race, and genetic profile; and determining a trend in treatment plan compliance in a regional specific population group that includes the patient and multiple additional patients.

[0012] As another example, the processor may be configured to use the data in at least identifying a failure in the administration of the drug, which failure may include the inability of the drug administration device to administer the drug to the patient, and the processor may be further configured to trigger an action causing the patient to receive a new drug administration device.

[0013] As another example, the processor may be configured to use the data in at least identifying a failure in the administration of the medication, which may include a user error in medication delivery, and the processor may be further configured to trigger an alert indicating the identified failure.

[0014] For another example, the processor may be configured to use the data in at least identifying a failure in the administration of the drug, which failure may include an irregularity in the administration of the dose that is at least partially delivered to the patient, and the processor may be further configured to correlate the irregularity with the patient's clinical outcome to determine whether the patient's clinical outcome is better than the clinical outcomes of other patients who received the drug.

[0015] For another example, the processor may be configured to use the data upon at least determining that additional data is needed from the drug administration device and triggering a request for the additional data to be wirelessly transmitted from the communication interface of the server to the communication interface of the drug administration device, and the additional data may include at least one of the model number of the drug administration device, the batch number of the drug administration device, the size of the dose size, the type of the drug, and the viscosity of the drug when the drug is administered.

[0016] As another example, the processor may be configured to use the data in predictive modeling of at least the patient's clinical outcome, and the processor may be further configured to use physician-input data regarding the patient in performing the predictive modeling.

[0017] For another example, the system may also include: a plurality of additional drug administration devices, each additional drug administration device being configured to deliver at least one dose of the drug from the each additional drug administration device to a different patient, each of the additional drug administration devices may include a sensor configured to sense information related to the drug administration device and at least one of the drug, and each of the additional drug administration devices may include a communication interface configured to wirelessly transmit data indicating the sensed information to the server.

[0018] For another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0019] In another embodiment, a drug administration system is provided, the drug administration system comprising: a server comprising a communication interface configured to wirelessly receive data transmitted by a communication interface of each of a plurality of drug administration devices, each drug administration device configured to administer the same drug to a different patient in a plurality of patients. The server comprises a processor configured to use the data in at least one of: correlating the patients' use of the drug with the patients' clinical outcomes; performing a cost analysis comprising comparing the patients' clinical outcomes with the clinical outcomes of other patients who received a different drug than the drug delivered to the patient; comparing the side effects experienced by the patient with the side effects experienced by other patients who received a different drug than the drug delivered to the patient; determining whether the drug was delivered to the patients in compliance with their individual treatment plans; identifying a failure in any of the administrations of the drug; determining that additional data is needed from any of the drug administration devices and triggering a request for the additional data to be wirelessly transmitted from the communication interface of the server; and predictively modeling the patients' clinical outcomes.

[0020] The system can be varied in a variety of ways. For example, each of the drug administration devices can be selected from the group consisting of: a syringe, a syringe, an inhaler, a nasal spray device, and an infusion pump.

[0021] As another example, the processor may be configured to use the data to at least correlate the use of the drug by these patients with the clinical outcomes of these patients, and the processor may also be configured to do at least one of: identify trends in patient outcomes among the multiple patients, and monitor side effects of the drug on the multiple patients.

[0022] For another example, the processor may be configured to use the data in at least performing the cost analysis, and the processor may be further configured to identify a second drug that has a lower cost than the drug and is associated with clinical outcomes that are substantially the same as the clinical outcomes for the patients.

[0023] As another example, the processor may be configured to use the data in at least determining whether the medication was delivered to the patients in compliance with their individual treatment plans, and the processor may be further configured to use the determination in at least one of: generating an alert to a physician indicating at least one of the patients' compliance, and determining a trend in the patients' compliance.

[0024] As another example, the processor may be configured to use the data in at least identifying a failure in the administration of the drug, which failure may include the inability of the drug administration device to administer the drug to the patient, and the processor may be further configured to trigger an action causing the patient to receive a new drug administration device.

[0025] As another example, the processor may be configured to use the data in at least identifying a failure in any of the administrations of the drug, which failure may include user error in drug delivery, and the processor may be further configured to trigger an alert indicating the identified failure.

[0026] For another example, the processor may be configured to use the data in at least identifying a failure in any of the administrations of the drug, which failure may include an irregularity in any of the administrations being at least partially delivered, and the processor may be further configured to correlate the irregularity with the clinical outcomes of the patients to determine whether the clinical outcomes of the patients are better than the clinical outcomes of other patients who received the drug.

[0027] For another example, the processor may be configured to use the data upon at least determining that additional data is needed from any of the drug administration devices and triggering a request for the additional data to be wirelessly transmitted from the communication interface of the server, and the additional data may include at least one of the model of the drug administration device, the batch number of the drug administration device, the size of the dose size, the type of the drug, and the viscosity of the drug when the drug is administered.

[0028] As another example, the processor may be configured to use the data in predictive modeling of at least the clinical outcomes of the patients, and the processor may be further configured to use physician-input data regarding the patients in performing the predictive modeling.

[0029] For another example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

[0030] In another aspect, a method of administering a drug is provided. In one embodiment, the method includes sensing information related to at least one of the drug administration device and the drug using a sensor of the drug administration device. The method also includes wirelessly transmitting data indicating the sensed information to a server using a communication interface of the drug administration device. The method also includes a processor of the server using the data to perform at least one of the following: correlating the patient's use of the drug with the patient's clinical outcomes; performing a cost analysis comprising comparing the patient's clinical outcomes with clinical outcomes of other patients who received a different drug than the drug delivered to the patient; comparing side effects experienced by the patient with side effects experienced by other patients who received a different drug than the drug delivered to these patients; determining whether the drug was delivered to the patient in compliance with the patient's treatment plan; identifying a failure in the administration of the drug; determining that additional data is needed from the drug administration device and triggering a request for the additional data to be wirelessly transmitted from the communication interface of the server to the communication interface of the drug administration device; and performing predictive modeling of the patient's clinical outcomes.

[0031] This method can have any number of variations. For example, the drug includes at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The present invention is described with reference to the following drawings:

[0033] Figure 1 is a schematic diagram of a first type of drug administration device, namely an autoinjector;

[0034] Figure 2 is a schematic diagram of a second type of drug administration device, namely an infusion pump;

[0035] Figure 3 is a schematic diagram of a third type of drug administration device, namely an inhaler;

[0036] Figure 4 is a schematic diagram of a fourth type of drug administration device, namely a nasal spray device;

[0037] Figure 5A is a schematic diagram of a general drug administration device;

[0038] Figure 5B is a schematic diagram of a universal drug administration device;

[0039] Figure 6 is a schematic diagram of a housing for a dosage form;

[0040] Figure 7 is a schematic diagram of one embodiment of a drug administration device and a communication network system with which the housing is operable;

[0041] Figure 8 is a schematic diagram of one embodiment of a drug administration device and a computer system with which the housing is operable; and

[0042] Figure 9 is a flow chart illustrating one embodiment of a method of updating a patient monitoring form and identifying one or more abnormal sensed parameters. DETAILED DESCRIPTION

[0043] Certain exemplary embodiments will now be described to provide an overall understanding of the principles of structure, function, manufacture, and use of the devices, systems, and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will appreciate that the devices, systems, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of the invention is limited only by the claims. The features shown or described in conjunction with an exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the invention.

[0044] In addition, in the present disclosure, components with similar names in various embodiments generally have similar features, so in a specific embodiment, it is not necessary to fully set forth every feature of each component with similar names. In addition, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices and methods. Those skilled in the art will recognize that the equivalent dimensions of such linear and circular dimensions can be easily determined for any geometric shape. Those skilled in the art will understand that the dimensions may not be exact values, but are considered to be approximately at that value due to any number of factors such as manufacturing tolerances and the sensitivity of the measuring equipment. The size and shape of the systems and devices and their components may depend at least on the size and shape of the components with which the systems and devices will be used.

[0045] Examples of various types of drug administration devices, namely, an autoinjector 100 , an infusion pump 200 , an inhaler 300 , and a nasal spray device 400 , are described below with reference to the above-mentioned figures.

[0046] Auto-injectors

[0047] Figure 11 is a schematic, illustrative view of a first type of drug delivery device, namely an injection device (in this example, an autoinjector 100), that can be used with the embodiments described herein. The autoinjector 100 includes a drug holder 110 that holds the drug to be dispensed and a dispensing mechanism 120 configured to dispense the drug from the drug holder 110 so that the drug can be administered to a patient. The drug holder 110 typically takes the form of a container containing the drug, such as a syringe or vial, or any other suitable container capable of holding the drug. The autoinjector 100 includes a discharge nozzle 122, such as the needle of a syringe, disposed at the distal end of the drug holder 110. The dispensing mechanism 120 includes a drive element 124, which may also include a piston and / or piston rod, and a drive mechanism 126. The dispensing mechanism 120 is located proximal to the end of the drug holder 110 and is positioned toward the proximal end of the autoinjector 100.

[0048] The autoinjector 100 includes a housing 130 that contains a medication holder 110, a drive element 124, and a drive mechanism 126 within the body of the housing 130, and includes a discharge nozzle 122, which will generally be completely contained within the housing prior to injection but will extend from the housing 130 during the injection sequence to deliver the medication. The dispensing mechanism 120 is arranged so that the drive element 124 is advanced through the medication holder 110 to dispense the medication through the discharge nozzle 122, thereby allowing the autoinjector to administer the medication retained in the medication holder 110 to the patient. In some cases, a user can manually advance the drive element 124 through the medication holder 110. In other cases, the drive mechanism 126 may include a stored energy source 127 that advances the drive element 124 without user assistance. The stored energy source 127 may include a resilient biasing member such as a spring or pressurized gas, or an electric motor and / or a gearbox.

[0049] The autoinjector 100 includes a dispensing mechanism protection mechanism 140. The dispensing mechanism protection mechanism 140 generally has two functions. First, the dispensing mechanism protection mechanism 140 can function to prevent access to the discharge nozzle 122 before and after an injection. Second, the autoinjector 100 can function so that when placed in an activated state, for example, when the dispensing mechanism protection mechanism 140 is moved to the unlocked position, the dispensing mechanism 120 can be activated.

[0050] When the drug holder 110 is in its retracted position proximally within the housing 130, the protective mechanism 140 covers at least a portion of the discharge nozzle 122. This is to hinder contact between the discharge nozzle 122 and the user. Alternatively or in addition, the protective mechanism 140 itself is configured to retract proximally to expose the discharge nozzle 122 so that the discharge nozzle can come into contact with the patient. The protective mechanism 140 includes a shield member 141 and a return spring 142. When no force is applied to the distal end of the protective mechanism 140, the return spring 142 acts to cause the shield member 141 to extend from the housing 130, thereby covering the discharge nozzle 122. If the user applies a force to the shield member 141 against the action of the return spring 142 to overcome the bias of the return spring 142, the shield member 141 retracts into the housing 130, thereby exposing the discharge nozzle 122. Alternatively or additionally, the protection mechanism 140 may include an extension mechanism (not shown) for extending the discharge nozzle 122 beyond the housing 130 and may also include a retraction mechanism (not shown) for retracting the discharge nozzle 122 into the housing 130. Alternatively or additionally, the protection mechanism 140 may include a housing cap and / or a discharge nozzle cover that may be attached to the autoinjector 100. Removing the housing cap will typically also remove the discharge nozzle cover from the discharge nozzle 122.

[0051] The autoinjector 100 also includes a trigger 150. The trigger 150 includes a trigger button 151 that is located on an exterior surface of the housing 130 such that the trigger button is accessible to a user of the autoinjector 100. When the user depresses the trigger 150, the trigger acts to release the drive mechanism 126, causing the drug to be expelled from the drug holder 110 via the drive element 124 and, in turn, the discharge nozzle 122.

[0052] The trigger 150 can also cooperate with the shield member 141 in such a way that activation of the trigger 150 is prevented until the shield member 141 has been fully retracted proximally into the housing 130 into an unlocked position, for example, by pushing the distal end of the shield member 141 against the patient's skin. Once this has been accomplished, the trigger 150 is unlocked and the autoinjector 100 is activated, allowing the trigger 150 to be depressed and an injection and / or drug delivery sequence to be initiated. Alternatively, proximally retracting the shield member 141 into the housing 130 alone can be used to activate the drive mechanism 126 and initiate an injection and / or drug delivery sequence. In this manner, the autoinjector 100 includes a device operation prevention mechanism that prevents dispensing of a drug by, for example, preventing accidental release of the dispensing mechanism 120 and / or accidental actuation of the trigger 150.

[0053] Although the foregoing description relates to one example of an autoinjector, this example is presented for illustration only and the present invention is not limited to this autoinjector. Those skilled in the art will appreciate that various modifications to the described autoinjector may be implemented within the scope of the present disclosure.

[0054] The autoinjectors of the present disclosure may be used to administer any of a variety of drugs, such as any of epinephrine, rebif, etanercept, enrofloxacin, atropine, pralidoxime chloride, and diazepam.

[0055] Infusion pump

[0056] In other cases, patients may require precise, continuous drug delivery or regular or frequent drug delivery at set periodic intervals. Infusion pumps can provide this controlled drug infusion by facilitating the administration of medication at a precise rate that keeps drug concentrations within the therapeutic range, without requiring frequent attention from healthcare professionals or patients.

[0057] Figure 2 2 is a schematic illustrative view of a second type of drug delivery device, i.e., an infusion pump 200, which can be used with the embodiments described herein. The infusion pump 200 includes a drug holder 210 in the form of a reservoir for accommodating the drug to be delivered, and a dispensing mechanism 220 including a pump 216 adapted to dispense the drug contained in the reservoir so that the drug can be delivered to the patient. These components of the infusion pump are located within a housing 230. The dispensing mechanism 220 also includes an infusion line 212. When the pump 216 is actuated, the drug is delivered from the reservoir via the infusion line 212, which can be in the form of a cannula. The pump 216 can be in the form of an elastomeric pump, a peristaltic pump, an osmotic pump, or a motor-controlled piston in a syringe. Typically, the drug is delivered intravenously, but subcutaneous infusion, intraarterial infusion, and epidermal infusion can also be used.

[0058] The infusion pumps of the present disclosure can be used to administer any of a variety of drugs, such as any of insulin, atropine sulfate, avibactam sodium, bendamustine hydrochloride, carboplatin, daptomycin, epinephrine, levetiracetam, oxaliplatin, paclitaxel, pantoprazole sodium, treprostinil, vasopressin, voriconazole, and zoledronic acid.

[0059] The infusion pump 200 includes control circuitry, such as a processor 296, in addition to a memory 297 and a user interface 280, which together provide a triggering mechanism and / or a dose selector for the pump 200. The user interface 280 may be implemented as a display screen located on the housing 230 of the infusion pump 200. The control circuitry and user interface 280 may be located within the housing 230 or external to the housing and communicate with the pump 216 via a wired or wireless interface to control the operation of the pump.

[0060] The actuation of pump 216 is controlled by processor 296, and this processor communicates with pump 216 to control the operation of pump.Processor 296 can be programmed by user (for example, patient or healthcare professional) via user interface 280.This makes infusion pump 200 deliver medicine to patient in a controlled manner.User can input parameter, such as infusion duration and delivery rate.Delivery rate can be set to constant infusion rate by user, or can be set to setting interval for periodic delivery, and these are usually within preprogrammed limit.The programming parameters for controlling pump 216 are stored in the memory 297 that communicates with processor 296 and retrieved from this memory.User interface 280 can adopt the form of touch screen or keyboard.

[0061] Power source 295 provides power to pump 216 and may take the form of an energy source integral to pump 216 and / or a mechanism for connecting pump 216 to an external power source.

[0062] The infusion pump 200 can take a variety of different physical forms depending on its intended use. It can be a fixed, non-portable device, such as for use at a patient's bedside, or it can be an ambulatory infusion pump designed to be portable or wearable. An integrated power source 295 is particularly beneficial for ambulatory infusion pumps.

[0063] While the foregoing description relates to an example of an infusion pump, this example is provided for illustration only. The present disclosure is not limited to this infusion pump. Those skilled in the art will appreciate that various modifications to the described infusion pump may be implemented within the scope of the present disclosure. For example, the processor may be preprogrammed such that the infusion pump need not include a user interface.

[0064] inhaler

[0065] Figure 33 is a schematic diagram of a third type of drug administration device, i.e., an inhaler 300. Inhaler 300 includes a drug holder 310 in the form of a canister. Drug holder 310 contains a drug that will typically be in the form of a solution or suspension with a suitable carrier fluid. Inhaler 300 also includes a dispensing mechanism 320, which includes a pressurized gas for pressurizing drug holder 310, a valve 325, and a nozzle 321. Valve 325 forms the outlet of drug holder 310. Valve 325 includes a narrow opening 324 formed in drug holder 310 and a movable element 326 that controls opening 324. When movable element 326 is in a rest position, valve 325 is in a closed or unactuated state, in which opening 324 is closed and drug holder 310 is sealed. When movable element 326 is actuated from the rest position to the actuated position, valve 325 is actuated to an open state, in which opening 324 is open. In the embodiment of the present invention, inhaler 300 is a kind of medicine holder 310, and it is characterized in that: it is a kind of medicine holder 310 that is used for the medicine of medicine holder 310.In one embodiment, inhaler 300 is a kind of medicine holder 310, and it is a kind of medicine holder 310 that is used for the medicine of medicine holder 310.In one embodiment, inhaler 300 is a kind of medicine holder 310, and it is a kind of medicine holder 310 that is used for the medicine of medicine holder 310.In another ...

[0066] The medicine holder 310 is removably retained in the housing 330 of the inhaler 300. The passage 333 formed in the housing 330 connects the first opening 331 in the housing 330 and the second opening 332 in the housing 330. The medicine holder 310 is received in the passage 333. The medicine holder 310 can be slidably inserted into the passage 333 through the first opening 331 of the housing 330. The second opening 332 of the housing 330 forms an oral cavity piece 322 that is configured to be placed in the patient's oral cavity, or is configured to be placed in the nasal cavity piece in the patient's nostril, or is configured to be placed on the mask over the patient's mouth and nose. The medicine holder 310, the first opening 331 and the passage 333 are sized so that air can flow through the passage 333, flow around the medicine holder 310, and flow between the first opening 331 and the second opening 332. The inhaler 300 can be provided with a dispensing mechanism protection mechanism 140 in the form of a cap (not shown), which can be assembled to the oral cavity piece 322.

[0067] Inhaler 300 also includes a trigger 350, which includes a valve actuation feature 355 configured to actuate valve 325 when trigger 350 is activated. Valve actuation feature 355 is a protrusion from housing 330 into channel 333. Medication holder 310 can be slidably moved within channel 333 from a first position to a second position. In the first position, the end of movable element 326, which is in a stationary position, abuts against valve actuation feature 355. In the second position, medication holder 310 can be shifted toward valve actuation feature 355, so that valve actuation feature 355 moves movable element 326 into medication holder 310 to actuate valve 325 to an open state. The user's hand provides the required force to move medication holder 310 from the first position to the second position against the resiliently biased movable element 326. Valve actuation feature 355 includes an inlet 356 connected to nozzle 321. The inlet 356 of the valve actuation feature 355 is sized and positioned to couple to the opening 324 of the valve 325 so that the sprayed mist of droplets and / or gas cloud can enter the inlet 356 and exit the nozzle 321 to enter the passage 333. The nozzle 321 helps to atomize the bulk liquid into a mist of droplets and / or gas cloud.

[0068] The valve 325 provides a metering mechanism 370. The metering mechanism 370 is configured to close the valve after a measured amount of liquid, and therefore medication, has passed through the opening 324. This allows a controlled dose to be administered to the patient. Typically, the measured amount of liquid is preset, however, the inhaler 300 may be equipped with a dose selector 360 that can be operated by the user to change the defined amount of liquid.

[0069] Although the foregoing description relates to a particular example of an inhaler, this example is merely illustrative. Description should not be considered as being limited only to this inhaler. Those skilled in the art understand that numerous other types of inhalers and atomizers can be used together with the present disclosure. For example, medicine can be in powdered form, medicine can be in liquid form, or medicine can be atomized by a dispensing mechanism 320 comprising other forms of ultrasonic vibrations, compressed gas, vibrating nets or heat sources.

[0070] The inhalers of the present disclosure can be used to administer any of a variety of drugs, such as any of mometasone, fluticasone, ciclesonide, budesonide, beclomethasone, vilanterol, salmeterol, formoterol, umeclidinium, glycopyrrolate, tiotropium, aclidinium, indacaterol, salmeterol, and olodaterol.

[0071] Drug administration device

[0072] As will be appreciated from the foregoing, various components of a drug delivery device are common to all such devices. These components form the basic components of a universal drug administration device. A drug administration device delivers a drug to a patient, wherein the drug is provided in a defined dosage form within the drug administration device.

[0073] Nasal spray device

[0074] Figure 4 FIG4 is a schematic diagram of a fourth type of drug administration device, namely a nasal spray device 400. Nasal spray device 400 is configured to discharge medication into a patient's nose. Nasal spray device 400 includes a medication holder 402, which is configured to contain medication therein for delivery from device 400 to the patient. Medication holder 102 can have a variety of configurations, such as a bottle-shaped reservoir, a box, a vial (as in the illustrated embodiment), a blow-fill-seal (BFS) capsule, a blister pack, and the like. In an exemplary embodiment, medication holder 402 is a vial. Exemplary vials are formed from one or more materials, such as glass, a polymer, and the like. In some embodiments, the vial may be formed from glass. In other embodiments, the vial may be formed from one or more polymers. In yet other embodiments, different portions of the vial may be formed from different materials. Exemplary vials may include various features to facilitate sealing and storing medication therein, as described herein and shown in the accompanying drawings. However, those skilled in the art will appreciate that a vial may include only some of these features and / or may include a variety of other features known in the art. The vials described herein are intended to represent certain exemplary embodiments only.

[0075] The opening 404 of the nasal spray device 400 through which the drug leaves the nasal spray device 400 is formed in the tip 408 of the dispensing head 406 of the nasal spray device 400. The tip 408 is configured to be inserted into the patient's nostril. In an exemplary embodiment, the tip 408 is configured to be inserted into the patient's first nostril during the first operating phase of the nasal spray device 400, and to be inserted into the patient's second nostril during the second operating phase of the nasal spray device 400. The first operating phase and the second operating phase involve two separate actuations of the nasal spray device 400, the first actuation corresponding to the delivery of a first dose of the drug and the second actuation corresponding to the delivery of a second dose of the drug. In some embodiments, the nasal spray device 400 is configured to be actuated only once to deliver a single nasal spray. In some embodiments, the nasal spray device 400 is configured to be actuated three or more times to deliver three or more (e.g., four, five, six, seven, eight, nine, ten, etc.) nasal sprays.

[0076] The dispensing head 406 includes a depth guide 410 that is configured to contact the patient's skin between the first and second nostrils of the patient such that the longitudinal axis of the dispensing head 406 is substantially aligned with the longitudinal axis of the nostril into which the tip 408 is inserted. Those skilled in the art will understand that the longitudinal axes may not be precisely aligned but are considered to be substantially aligned due to any number of factors, such as manufacturing tolerances and the sensitivity of the measuring equipment.

[0077] In an exemplary embodiment, as in Figure 4 4. In the embodiment of the present invention, the dispensing head 406 has a conical shape, wherein the dispensing head 406 has a smaller diameter at its distal end than at its proximal end where the opening 404 is located. The relatively small diameter of the opening 404 facilitates spraying the drug out of the opening 404, as will be appreciated by those skilled in the art. A spray chamber 412, through which the drug is configured to pass before exiting the opening 404, is located within the proximal portion of the conical dispensing head 406, distal to the opening 404. As the drug rapidly passes through the spray chamber 412, the spray chamber 412 facilitates the production of a fine mist that passes through the opening 404 in a consistent spray pattern. Figure 4 Arrows 414 in illustrative figures illustrate the path that the drug travels from the drug holder 402 and out of the opening 404 .

[0078] In some embodiments, the dispensing head 406 may include two tips 408, each having an opening 404 therein, such that the nasal spray device 400 is configured to deliver a dose of medication to both nostrils simultaneously in response to a single actuation.

[0079] The dispensing head 406 is configured to be pushed toward the medication holder 402, e.g., by a user pushing down on the depth guide 410 to depress it, to actuate the nasal spray device 400. In other words, the dispensing head 406 is configured as an actuator so as to be actuated to drive the medication from the medication holder 402 out of the nasal spray device 400. In an exemplary embodiment, the nasal spray device 400 is configured to be self-administered, such that the user who actuates the nasal spray device 400 is the patient receiving the medication from the nasal spray device 400, but another person can also actuate the nasal spray device 400 to deliver medication to another person.

[0080] like Figure 4As shown by arrow 416 in FIG, actuation (e.g., depression) of the dispensing head 406 is configured to cause air to enter the medication holder 402. The air entering the medication holder 402 displaces the medication in the medication holder through the tube 418 and then into the metering chamber 420, which displaces the medication proximally through the cannula 422, through the spray chamber 412, and out of the opening 404. In response to the release of the dispensing head 406, e.g., the user stops pushing downward on the dispensing head 406, the biasing spring 426 causes the dispensing head 406 to return to its default resting position to position the dispensing head 406 relative to the medication holder 402 for subsequent actuation and medication delivery.

[0081] While the foregoing description relates to a specific example of a nasal spray device, this example is illustrative only. The description should not be considered limited to this nasal spray device. Those skilled in the art will appreciate that nasal spray device 400 may include different features in different embodiments, depending on various requirements. For example, nasal spray device 400 may lack depth guide 410 and / or may include any one or more of a device indicator, a sensor, a communication interface, a processor, a memory, and a power source.

[0082] The nasal spray devices of the present disclosure can be used to administer any of a variety of drugs, such as ketamine (e.g., ), esketamine (e.g., and ), naloxone (e.g., ) and sumatriptan (e.g., ) in any one of the following.

[0083] Figure 5A is a generalized schematic diagram of such a universal drug administration device 501, and Figure 5B is an exemplary embodiment of such a universal drug administration device 500. Examples of the universal drug administration device 500 include injection devices (eg, autoinjectors, jet injectors, and infusion pumps), nasal spray devices, and inhalers.

[0084] like Figure 5A As shown, the drug administration device 501 includes, in general form, features of a drug holder 10 and a dispensing mechanism 20. The drug holder 10 holds the drug in a dosage form to be administered. The dispensing mechanism 20 is configured to release the dosage form from the drug holder 10 so that the drug can be administered to a patient.

[0085] Figure 5BAnother general drug administration device 500 is shown that includes a number of additional features. Those skilled in the art will appreciate that these additional features are optional for different embodiments and may be used in a variety of different combinations, such that additional features may be present in or omitted from a given embodiment of a particular drug administration device depending on requirements such as the type of drug, the dosage form of the drug, the medical indication for treatment with the drug, safety requirements, whether the device is powered, whether the device is portable, whether the device is for self-administration, and many other requirements that will be apparent to those skilled in the art. Similar to Figure 5A The drug administration device 500 includes a housing 30 that houses a drug holder 10 and a dispensing mechanism 20.

[0086] The device 500 is provided with a trigger mechanism 50 for initiating the release of the drug from the drug holder 10 via the dispensing mechanism 20. The device 500 includes features of a metering / dosing mechanism 70 that measure out a set dose for release from the drug holder 10 via the dispensing mechanism 20. In this manner, the drug administration device 500 can provide a known dose of a determined size. The device 500 includes a dose selector 60 that enables a user to set the dose volume of the drug to be dispensed by the metering mechanism 70. The dose volume can be set to a specific value of a plurality of predefined discrete dose volumes, or any value of the predefined dose volumes within a range of dose volumes.

[0087] The device 500 may include a device operation prevention mechanism 40 or 25 that, when in a locked state, prevents and / or stops the dispensing mechanism 20 from releasing the drug from the drug holder 10, and, when in an unlocked state, allows the dispensing mechanism 20 to release the drug dose from the drug holder 10. This can prevent accidental administration of the drug, for example, by preventing administration at an incorrect time or preventing unintentional actuation. The device 500 also includes a dispensing mechanism protection mechanism 42 that prevents access to at least a portion of the dispensing mechanism 20, for example, for safety reasons. The device operation prevention mechanism 40 and the dispensing mechanism protection mechanism 42 may be the same component.

[0088] The device 500 may include a device indicator 85 configured to present information regarding the status of the drug administration device and / or the drug contained therein. The device indicator 85 may be a visual indicator, such as a display screen, or an audio indicator. The device 500 includes a user interface 80, which may be configured to present information regarding the device 500 to a user of the device 500 and / or enable the user to control the device 500. The device 500 includes a device sensor 92 configured to sense information related to the drug administration device and / or the drug contained therein, such as the dosage form and device parameters. For example, in an embodiment including a metering mechanism 70 and a dose selector 60, the embodiment may further include one or more device sensors 92 configured to sense one or more of the following: the dose selected by the user using the dose selector 60, the dose metered by the metering mechanism 70, and the dose dispensed by the dispensing mechanism 20. Similarly, an environmental sensor 94 is provided that is configured to sense information related to the environment in which the device 500 is located, such as the temperature of the environment, the location of the environment, and the time of day. There may be a dedicated location sensor 98 configured to determine the geographic location of the device 500, for example via satellite location determination such as GPS. The device 500 also includes a communication interface 99 that can communicate data about the device and / or medication that has been acquired from various sensors to the outside.

[0089] If desired, the device 500 includes a power source 95 for delivering electrical power to one or more electrical components of the device 500. The power source 95 can be a power source integral to the device 500 and / or a mechanism for connecting the device 500 to an external power source. The drug administration device 500 also includes a device computer system 90, which includes a processor 96 and a memory 97, which are powered by the power source 95 and communicate with each other and, optionally, with other electrical and control components of the device 500, such as the environmental sensor 94, the position sensor 98, the device sensor 92, the communication interface 99, and / or the indicator 85. The processor 96 is configured to obtain data acquired from the environmental sensor 94, the device sensor 92, the communication interface 99, the position sensor 98, and / or the user interface 80, and process the data to provide a data output, for example, to the indicator 85 and / or the communication interface 99.

[0090] In some embodiments, the drug administration device 500 is enclosed in a package 35. The package 35 may also include a combination of a processor 96, a memory 97, a user interface 80, a device indicator 85, a device sensor 92, a position sensor 98, and / or an environmental sensor 94 as described herein, and these may be located externally on the housing of the device 500.

[0091] Those skilled in the art will appreciate that the universal drug administration device 500, including the drug holder 10 and the dispensing mechanism 20, can be provided with the various optional features described above in a variety of different combinations. In addition, the drug administration device 500 can include more than one drug holder 10, optionally with more than one dispensing mechanism 20, such that each drug holder has its own associated dispensing mechanism 20.

[0092] Drug dosage form

[0093] Conventionally, drug administration devices utilize liquid dosage forms. However, it will be appreciated that other dosage forms are available.

[0094] One such common dosage form is a tablet. Tablets can be formed from a combination of drug and excipients that are compressed together. Other dosage forms are pastes, creams, powders, ear drops, and eye drops.

[0095] Additional examples of drug dosage forms include transdermal patches, drug-eluting stents, and intrauterine devices. In these examples, the body of the device includes the drug and can be configured to allow the drug to be released under certain circumstances. For example, a transdermal patch can include a polymer composition containing the drug. The polymer composition allows the drug to diffuse out of the polymer composition and into the patient's skin. Drug-eluting stents and intrauterine devices can operate in a similar manner. In this way, patches, stents, and intrauterine devices themselves can be considered drug holders with associated dispensing mechanisms.

[0096] Any of these dosage forms can be configured to initiate drug release by certain conditions. This can allow for drug release at a desired time or location after the dosage form has been introduced to a patient. In particular, drug release can be initiated by an external stimulus. Furthermore, these dosage forms can be contained within a housing prior to administration, which can be in the form of a package. This housing can include some of the optional features described above, which are utilized with the universal drug administration device 500.

[0097] The drug administered by the drug administration device of the present disclosure may be any substance that causes physiological or psychological changes in an organism when consumed. Examples of drugs that can be administered by the drug administration device of the present disclosure include 5-α-reductase inhibitors, 5-aminosalicylate, 5HT3 receptor antagonists, ACE inhibitors and calcium channel blockers, ACE inhibitors and thiazides, adamantane antivirals, adrenocortical steroids, adrenocortical steroid inhibitors, adrenergic bronchodilators, hypertensive emergency drugs, pulmonary hypertension drugs, aldosterone receptor antagonists, alkylating agents, allergen preparations, α-glucosidase inhibitors, alternative medicines, anti-amoebic drugs, aminoglycoside antibiotics, aminopenicillins, aminosalicylate, AMPA receptor antagonists, amylin analogs, analgesic complexes, Combination drugs, analgesics, androgens and anabolic steroids, angiotensin-converting enzyme inhibitors, angiotensin II inhibitors and calcium channel blockers, angiotensin II inhibitors and thiazides, angiotensin receptor blockers, angiotensin receptor blockers and neprilysin inhibitors, anorectal preparations, anorexia, antacids, anthelmintics, anti-angiogenic ophthalmic drugs, anti-CTLA-4 monoclonal antibodies, anti-infective drugs, anti-PD-1 monoclonal antibodies, (central) antiadrenergic drugs and thiazides, (peripheral) antiadrenergic drugs and thiazides, centrally acting antiadrenergic drugs, peripherally acting antiadrenergic drugs, anti Androgens, antianginal drugs, antiarrhythmic drugs, antiasthmatic combination drugs, antibiotics / antineoplastics, anticholinergic antiemetics, anticholinergic antiparkinsonian drugs, anticholinergic bronchodilators, anticholinergic chronotropic drugs, anticholinergic / antispasmodics, anticoagulant reversal agents, anticoagulants, antispasmodics, antidepressants, antidiabetic drugs, antidiabetic combination drugs, antidiabetic drugs, antidiarrheal drugs, antidiuretic hormones, antidote, antiemetic / antidizziness drugs, antifungal drugs, antigonadotropins, antigout drugs, antihistamines, antihyperlipidemic drugs, antihyperlipidemic combination drugs, antihypertensive combination drugs, antihyperuric acid drugs, antimalarials, antimalarial combination drugs, antimalarial quinolones, antimanic drugs, antimetabolic drugs Miscellaneous drugs, antimigraine drugs, antineoplastic combination drugs, antineoplastic antidotes, antineoplastic interferons, antineoplastic drugs, antiparkinsonian drugs, antiplatelet drugs, antipseudomonal penicillins, antipsoriatic drugs, antipsychotic drugs, antirheumatic drugs, antiseptics and antiseptics, antithyroid drugs, antitoxins and antivenoms, antituberculosis drugs, antituberculosis combination drugs, antitussive drugs, antiviral agents, antiviral boosters, antiviral combination drugs, antiviral interferons, anxiolytics, sedatives, and hypnotics, aromatase inhibitors, atypical antipsychotics, azole antifungals, bacterial vaccines, barbiturate anticonvulsants, barbiturates, BCR-ABL tyrosine kinase inhibitors, benzodiazepines Anticonvulsants, benzodiazepines beta-blockers and calcium channel blockers, beta-blockers and thiazides, beta-adrenergic blockers, beta-lactamase inhibitors, bile acid sequestrants, biologics, bisphosphonates, bone morphogenetic protein, bone resorption inhibitors, bronchodilator combinations, bronchodilators, calcimimetics, calcineurin inhibitors, calcitonin, calcium channel blockers, carbamate anticonvulsants, carbapenems, carbapenem / beta-lactamase inhibitors, carbonic anhydrase inhibitor anticonvulsants, carbonic anhydrase inhibitors, cardiac stress medications, cardioselective beta-blockers, cardiovascular medications, catecholamines, cation exchange resins, CD20 monoclonal antibodies, CD30 monoclonal antibodies, CD33 monoclonal antibodies, CD38 monoclonal antibodies, CD52 monoclonal antibodies, CDK β-lactamase inhibitors, cephalosporins, cephalosporin / β-lactamase inhibitors, cerumen-activating agents, CFTR combination drugs, CFTR potentiators, CGRP inhibitors, chelators, chemokine receptor antagonists, chloride channel activators, cholesterol absorption inhibitors, cholinergic agonists, cholinergic muscle stimulants, cholinesterase inhibitors, CNS stimulants, coagulation regulators, colony-stimulating factors, birth control pills, adrenocorticotropic hormone, coumarins and indanediones, COX-2 inhibitors, decongestants, dermatological drugs, diagnostic radiopharmaceuticals, diarylquinolines, dibenzazepines antispasmodics, digestive enzymes, dipeptidyl peptidase 4 inhibitors, diuretics, dopaminergic antiparkinsonian drugs, drugs for alcohol dependence, echinocandins, EGFR inhibitors, estrogen receptor antagonists, estrogens, expectorants, factor Xa inhibitors, fatty acid derivative antispasmodics, fibric acid derivatives, first-generation cephalosporins, fourth-generation cephalosporins, functional bowel disorder drugs, cholelithiolytics, gamma-aminobutyric acid analogs, gamma-aminobutyric acid reuptake inhibitors, gastrointestinal drugs, general anesthetics, genitourinary drugs, GI stimulants, glucocorticoids, glucose-raising drugs, glycopeptide antibiotics, glycoprotein platelet inhibitors, glycylcyclines, gonadotropin-releasing hormone, gonadotropin-releasing hormone antagonists, gonadotropins, I Group 2 antiarrhythmics, Group 2 antiarrhythmics, Group 3 antiarrhythmics, Group 4 antiarrhythmics, Group 5 antiarrhythmics, growth hormone receptor blockers, growth hormone, guanylate cyclase-C agonists, Helicobacter pylori eradicators, H2 antagonists, Hedgehog pathway inhibitors, hematopoietic stem cell mobilizers, heparin antagonists, heparin, HER2 inhibitors, herbal products, histone deacetylase inhibitors, hormones, hormone / antineoplastic agents, hydantoin anticonvulsants, hydrazide derivatives, illicit (street) drugs, immunoglobulins, immunologic agents, immunostimulants, immunosuppressants, aphrodisiacs, in vivo diagnostic biologics, incretin analogs, inhaled anti-infectives, inhaled corticosteroids, inotropes, insulin, insulin growth factors, integrase chain transfer inhibitors, interferons, interleukin inhibitors, interleukins, intravenous nutritional products, iodinated contrast media, ionic iodinated contrast media, iron products, ketolides, laxatives, antileprosy drugs, leukotriene modifiers, lincomycin derivatives, local injectable anesthetics, local injectable anesthetics and corticosteroids, loop diuretics, pulmonary surfactants, lymph stains, lysosomal enzymes, macrolide derivatives, macrolide drugs, magnetic resonance imaging contrast agents, mast cell stabilizers, medical gases, glinides, metabolic drugs, methylxanthines, mineralocorticoids, minerals and electrolytes, miscellaneous drugs, miscellaneous analgesics, miscellaneous antibiotics, miscellaneous anticonvulsants, miscellaneous antidepressants, miscellaneous antidiabetic drugs, miscellaneous antiemetics, Miscellaneous antifungals, miscellaneous antihyperlipidemics, miscellaneous antihypertensive combination drugs, miscellaneous antimalarials, miscellaneous antineoplastics, miscellaneous antiparkinsonian drugs, miscellaneous antipsychotics, miscellaneous antituberculosis drugs, miscellaneous antivirals, miscellaneous anxiolytics, sedatives and hypnotics, miscellaneous bone resorption inhibitors, miscellaneous cardiovascular drugs, miscellaneous central nervous system drugs, miscellaneous coagulation regulators, miscellaneous diagnostic dyes, miscellaneous diuretics, miscellaneous genitourinary drugs, miscellaneous GI drugs, miscellaneous hormones, miscellaneous metabolic drugs, miscellaneous ophthalmic drugs, miscellaneous otic drugs, miscellaneous respiratory drugs, miscellaneous sex hormones, miscellaneous topical drugs, miscellaneous unclassified drugs, miscellaneous vaginal drugs, mitotic inhibitors, monoamine oxidase inhibitors, oral and throat products, mTOR inhibitors, mucolytics, multikinase inhibitors,Muscle relaxants, mydriatics, narcotic analgesic combination drugs, narcotic analgesics, nasal anti-infectives, nasal antihistamines and decongestants, nasal lubricants and lavages, nasal preparations, nasal steroids, natural penicillins, enkephalinase inhibitors, neuraminidase inhibitors, neuromuscular blockers, neuronal potassium channel openers, next-generation cephalosporins, nicotinic acid derivatives, NK1 receptor antagonists, NNRTIs, non-cardioselective beta-blockers, non-iodinated contrast media, non-ionic iodinated contrast media, non-sulfonylureas, non-steroidal anti-inflammatory drugs, NS5A inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), health products, nutritional products, ophthalmic anesthetics, ophthalmic anti-infectives, ophthalmic anti-inflammatory drugs, ophthalmic antihistamines and decongestants, ophthalmic Diagnostic drugs, ophthalmic glaucoma drugs, ophthalmic lubricants and irrigants, ophthalmic preparations, ophthalmic steroids, ophthalmic steroids and anti-infectives, ophthalmic surgical drugs, oral nutritional supplements, other immunostimulants, other immunosuppressants, otic anesthetics, otic anti-infectives, otic preparations, otic steroids, otic steroids and anti-infectives, oxazolidinedione antispasmodics, oxazolidinedione antibiotics, parathyroid hormone and analogs, PARP inhibitors, PCSK9 inhibitors, penicillinase-resistant penicillins, penicillins, peripheral opioid receptor antagonists, peripheral opioid receptor mixed agonists / antagonists, peripheral vasodilators, peripherally acting anti-obesity drugs, phenothiazine antiemetics, phenothiazine antipsychotics, phenylpiperazine antidepressants, phosphate binders, PI3K Inhibitors, plasma expanders, platelet aggregation inhibitors, platelet stimulants, polyenes, potassium-sparing diuretics and thiazides, potassium-sparing diuretics, probiotics, progesterone receptor modulators, progestogens, prolactin inhibitors, prostaglandin D2 antagonists, protease inhibitors, protease-activated receptor-1 antagonists, proteasome inhibitors, proton pump inhibitors, psoralens, psychotherapeutic drugs, psychotherapeutic combination drugs, purine nucleosides, pyrrolidine anticonvulsants, quinolones, radiocontrast agents, radioactive adjuvants, radiotherapy drugs, radioactive co-acting agents, radiopharmaceuticals, recombinant human erythropoietin, renin inhibitors, respiratory system drugs, respiratory inhalation products, rifamycin derivatives, salicylates, sclerosing drugs, second-generation cephalosporins, selected Estrogen receptor modulators, selective immunosuppressants, selective phosphodiesterase-4 inhibitors, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, serotonin-containing neural tube primitive intestinal regulators, sex hormone combination drugs, sex hormones, SGLT-2 inhibitors, skeletal muscle relaxant combination drugs, skeletal muscle relaxants, smoking cessation drugs, somatostatin and somatostatin analogs, spermicides, statins, sterile lavage solutions, streptogramins, streptomyces derivatives, succinimide antispasmodics, sulfonamides, sulfonylureas, synthetic ovulation stimulants, tetracyclic antidepressants, tetracyclines, therapeutic radiopharmaceuticals, therapeutic vaccines, thiazide diuretics, thiazolidinediones, thioxanthenes, third-generation cephalosporins,Thrombin inhibitors, thrombolytics, thyroid medications, TNFα inhibitors, labor suppressants, topical acne medications, topical medications, topical allergy diagnostics, topical anesthetics, topical anti-infectives, topical anti-rosacea medications, topical antibiotics, topical antifungals, topical antihistamines, topical antineoplastics, topical antipsoriatics, topical antivirals, topical astringents, topical debridements, topical depigmenting agents, topical emollients, topical keratolytics, topical nonsteroidal anti-inflammatory drugs, topical photochemotherapeutics, topical rubefacients, topical steroids, topical steroids and anti-infectives, transthyretin stabilizers, triazine antispasmodics, tricyclic antidepressants, trifunctional monoclonal antibodies, ultrasound contrast agents, upper respiratory tract combination drugs, urea antispasmodics, urea cycle disorder drugs, urinary anti-infectives, urinary antispasmodics, urinary pH regulators, uterotonics, combination vaccines, vaginal anti-infectives, vaginal preparations, vasodilators, vasopressin antagonists, vasopressors, VEGF / VEGFR inhibitors, viral vaccines, viscosupplements, vitamin and mineral combination drugs, vitamins or VMAT2 inhibitors. The drug administration device of the present disclosure can administer a drug selected from the group consisting of epinephrine, libido, etanercept, anranesip, atropine, pralidoxime chloride, diazepam, insulin, atropine sulfate, avibactam sodium, bendamustine hydrochloride, carboplatin, daptomycin, epinephrine, levetiracetam, oxaliplatin, paclitaxel, pantoprazole sodium, treprostinil, vasopressin, voriconazole, zoledronic acid, mometasone, fluticasone, ciclesonide, budesonide, beclomethasone, vilanterol, salmeterol, formoterol, umeclidinium bromide, glycopyrrolate, tiotropium bromide, aclidinium bromide, indacaterol, salmeterol, and olodaterol.

[0098] As mentioned above, a drug administration device may be used to deliver any of a variety of drugs. Examples of drugs that may be delivered using a drug administration device as described herein include (Infliximab), (Ustekinumab), (golimumab), Simponi (golimumab), (daratumumab), (guselkumab), (epoetin alfa), Risperdal (risperidone), Invega (paliperidone palmitate), (esketamine), ketamine, and Invega (paliperidone palmitate).

[0099] Drug shell

[0100] As described above, the dosage form can be provided in a holder suitable for the particular dosage form being utilized. For example, a drug in a liquid dosage form can be held in a holder in the form of a vial with a stopper or a syringe with a plunger prior to administration. A drug in a solid or powder dosage form (e.g., as a tablet) can be contained in a housing that is arranged to securely hold the tablet prior to administration.

[0101] The housing may include one or more drug holders, wherein each holder contains a dosage form, for example, the drug may be in tablet dosage form, and the housing may be in the form of a blister pack, wherein a tablet is held within each of the plurality of holders. The holders are in the form of recesses in the blister pack.

[0102] Figure 6 A housing 630 is depicted that includes a plurality of medication holders 610, each containing a dosage form 611. The housing 630 may have at least one environmental sensor 94 configured to sense information related to the environment in which the housing 630 is located, such as the temperature, time, or location of the environment. The housing 630 may include at least one device sensor 92 configured to sense information related to medication contained in the dosage form 611 within the holder 610. A dedicated location sensor 98 may be present that is configured to determine the geographic location of the housing 630, for example, via satellite location determination, such as GPS.

[0103] The housing 630 may include an indicator 85 configured to present information to a user of the medication housing regarding the status of the medication in the dosage form 611 contained within the holder 610. The housing 630 may also include a communication interface 99 that may communicate information to the outside via wired or wireless data transfer of data related to the medication housing 630, the environment, time or location, and / or the medication itself.

[0104] If desired, the housing 630 may include a power source 95 for delivering electrical power to one or more electrical components of the housing 630. The power source 95 may be a power source integral to the housing 630 and / or a mechanism for connecting the housing 630 to an external power source. The housing 630 may also include a device computer system 90 comprising a processor 96 and a memory 97, which are powered by the power source 95 and which communicate with each other and, optionally, with other electrical and control components of the housing 630, such as the environmental sensors 94, the position sensors 98, the device sensors 92, the communication interface 99, and / or the indicator 85. The processor 96 is configured to obtain data acquired from the environmental sensors 94, the device sensors 92, the communication interface 99, the position sensors 98, and / or the user interface 80 and process the data to provide a data output, for example, to the indicator 85 and / or the communication interface 99.

[0105] The housing 630 may be in the form of a packaging. Alternatively, there may be an additional packaging to contain and surround the housing 630.

[0106] The retainer 610 or an attached packaging piece itself may include one or more of the device sensor 92, environmental sensor 94, indicator 85, communication interface 99, power source 95, position sensor 98 and device computer system as described above, the device computer system including a processor 96 and memory 97.

[0107] Electronic Communications

[0108] As mentioned above, the communication interface 99 may be associated with the drug administration device 500 or drug housing 630 by being included within or on the housing 30, 630 or alternatively within the packaging 35. Such a communication interface 99 may be configured to communicate with a remote computer system such as Figure 7 The central computer system 700 shown communicates with the Figure 7 As shown, a communication interface 99 associated with the drug administration device 500 or housing 630 is configured to communicate with a central computer system 700 via a communication network 702 from any number of locations, such as a medical facility 706 (e.g., a hospital or other medical care center), a residential base 708 (e.g., a patient's home or office or a caregiver's home or office), or a mobile location 710. The communication interface 99 can be configured to access the system 700 via a wired and / or wireless connection to the network 702. In an exemplary embodiment, Figure 6 The communication interface 99 is configured to access the system 700 wirelessly, such as through a Wi-Fi connection, which may facilitate accessibility to the system 700 from virtually anywhere in the world.

[0109] Those skilled in the art will appreciate that the system 700 may include security features such that aspects of the system 700 available to any particular user may be determined based on, for example, the user's identity and / or the location from which the user is accessing the system. To this end, each user may have a unique username, password, biometric data, and / or other security credentials to facilitate access to the system 700. Received security parameter information may be checked against a database of authorized users to determine whether the user is authorized and the extent to which the user is permitted to interact with the system, view information stored in the system, and the like.

[0110] Computer system

[0111] As discussed herein, one or more aspects or features of the subject matter described herein, such as components of the central computer system 700, processor 96, power source 95, memory 97, communication interface 99, user interface 80, device indicator 85, device sensor 92, environmental sensor 94, and position sensor 98, can be implemented in digital electronic circuitry, integrated circuits, specially designed application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), computer hardware, firmware, software, and / or combinations thereof. These various aspects or features can include implementations in one or more computer programs that are executable and / or interpretable on a programmable system that includes at least one programmable processor, which can be either specialized or general purpose, coupled to receive data and instructions from and transmit data and instructions to a storage system, at least one input device, and at least one output device. The programmable system or computer system can include clients and servers. The clients and servers are typically remote from each other and typically interact through a communication network, such as the Internet, a wireless wide area network, a local area network, a wide area network, or a wired network. The relationship of client and server arises by virtue of the computer programs running on the respective computers having a client-server relationship to each other.

[0112] These computer programs (also referred to as programs, software, software applications, components or codes) include machine instructions for programmable processors and can be implemented in high-level programming languages, object-oriented programming languages, functional programming languages, logical programming languages ​​and / or in assembly / machine language. As used herein, the term "machine-readable medium" refers to any computer program product, device and / or device (e.g., disk, optical disk, memory, programmable logic device (PLD)) used to provide machine instructions and / or data to a programmable processor, including a machine-readable medium that receives machine instructions as machine-readable signals. The term "machine-readable signal" refers to any signal used to provide machine instructions and / or data to a programmable processor. A machine-readable medium can store such machine instructions in a non-transient manner, such as a non-transient solid-state memory or a magnetic hard drive or any equivalent storage medium. Alternatively or in addition, a machine-readable medium can store such machine instructions in a transient manner, such as a processor cache or other random access memory associated with one or more physical processor cores.

[0113] To enable user interaction, one or more aspects or features of the subject matter described herein, such as the user interface 80 (which may be integrated with or separate from the applicator 500 or housing 630), may be implemented on a computer having a display screen for displaying information to the user, such as, for example, a cathode ray tube (CRT), a liquid crystal display (LCD), or a light-emitting diode (LED) monitor. The display screen may allow input thereto directly (e.g., as a touch screen) or indirectly (e.g., via an input device such as a keypad or voice recognition hardware and software). Other types of devices may also be used to provide interaction with the user. For example, feedback provided to the user may be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user may be received in any form, including, but not limited to, sound, voice, or tactile input. As described above, in addition to the user interface 80, this feedback may be provided via one or more device indicators 85. The device indicators 85 may interact with one or more of the device sensors 92, environmental sensors 94, and / or position sensors 98 to provide this feedback or receive input from the user.

[0114] Figure 8 An exemplary embodiment of a computer system 700, depicted as computer system 800, is shown. The computer system includes one or more processors 896 configured to control the operation of the computer system 800. The processor 896 may include any type of microprocessor or central processing unit (CPU), including a programmable general-purpose or special-purpose microprocessor and / or any of a variety of proprietary or commercially available single-processor or multi-processor systems. The computer system 800 also includes one or more memories 897 configured to provide temporary storage for code to be executed by the processor 896 or for data retrieved from one or more users, storage devices, and / or databases. The memory 897 may include read-only memory (ROM), flash memory, one or more random access memories (RAM) (e.g., static RAM (SRAM), dynamic RAM (DRAM), or synchronous DRAM (SDRAM)), and / or a combination of memory technologies.

[0115] The various components of the computer system are coupled to a bus system 812. The bus system 812 shown is an abstract concept that represents any one or more separate physical buses, communication lines / interfaces, and / or multi-point or point-to-point connections connected through appropriate bridges, adapters, and / or controllers. The computer system 800 also includes one or more network interfaces 899 (also referred to herein as communication interfaces), one or more input / output (IO) interfaces 880, and one or more storage devices 810.

[0116] The communication interface 899 is configured to enable the computer system to communicate with a remote device (e.g., other computer systems and / or devices 500 or housing 630) over a network, and may be, for example, a remote desktop connection interface, an Ethernet adapter, and / or other local area network (LAN) adapter. The IO interface 880 includes one or more interface components to connect the computer system 800 to other electronic devices. For example, the IO interface 880 may include a high-speed data port, such as a universal serial bus (USB) port, a 1394 port, Wi-Fi, Bluetooth, etc. In addition, the computer system may be accessible to a human user, and therefore the IO interface 880 may include a display, a speaker, a keyboard, a pointing device, and / or various other video, audio, or alphanumeric interfaces. The storage device 810 includes any conventional medium for storing data in a non-volatile and / or non-transient manner. Therefore, the storage device 810 is configured to keep data and / or instructions in a persistent state, wherein the value is retained despite power interruption to the computer system. The storage device 810 may include one or more hard drives, flash drives, USB drives, optical drives, various media cards, magnetic disks, optical discs, and / or any combination thereof, and may be connected directly to a computer system or remotely (such as via a network) to the computer system. In an exemplary embodiment, the storage device 810 includes a tangible or non-transitory computer-readable medium configured to store data, such as a hard drive, flash drive, USB drive, optical drive, media card, magnetic disk, or optical disc.

[0117] Figure 8 The elements shown in the figure may be some or all of the elements of a single physical machine. In addition, not all elements shown need to be located on or in the same physical machine.

[0118] The computer system 800 may include a web browser for: retrieving web pages or other markup language streams, presenting those pages and / or streams (visually, audibly, or otherwise), executing scripts, controls, and other code on those pages / streams, accepting user input with respect to those pages / streams (e.g., for the purpose of completing input fields), issuing Hypertext Transfer Protocol (HTTP) requests with respect to those pages / streams or otherwise (e.g., for submitting server information from completed input fields), etc. The web pages or other markup language may be Hypertext Markup Language (HTML) or other conventional forms, including embedded Extensible Markup Language (XML), scripts, controls, etc. The computer system 800 may also include a web server for generating and / or delivering web pages to client computer systems.

[0119] like Figure 7 As shown above Figure 8The computer system 800 may form part of a central computer system 700 that communicates with one or more of the device computer systems 90 of one or more individual drug administration devices 500 or housings 630. Data, such as operating data of the devices 500 or housings 630 and medical data of patients acquired by such devices 500 or housings 630, may be exchanged between the central computer system 700 and the device computer systems 90.

[0120] As mentioned, the computer system 800 described above may also form part of a device computer system 90 that is integrated into or proximate to the drug administration device 500 or housing 630. In this regard, the one or more processors 896 correspond to the processor 96, the network interface 799 corresponds to the communication interface 99, the IO interface 880 corresponds to the user interface 80, and the memory 897 corresponds to the memory 97. In addition, additional storage devices 810 may also be present in the device computer system 90.

[0121] In an exemplary embodiment, the computer system 800 may form the device computer system 90 as a single unit, e.g., contained within a single drug administration device housing 30, contained within a single package 35 for one or more drug administration devices 500, or a housing 630 including a plurality of drug holders 610. The computer system 800 may form the central computer system 700 as a single unit, a single server, or a single tower.

[0122] The individual units may be modular such that various aspects thereof may be swapped in and out as needed for, e.g., upgrades, replacements, maintenance, etc., without disrupting the functionality of any other aspects of the system. Thus, the individual units may also be expandable, with the ability to be added as additional modules and / or additional functionality as desired and / or improved upon existing modules.

[0123] The computer system may also include any of a variety of other software and / or hardware components, including (as an example) an operating system and a database management system. Although an exemplary computer system is depicted and described herein, it should be understood that this is for reasons of generality and convenience. In other embodiments, the architecture and operation of the computer system may be different from those shown and described herein. For example, the memory 897 and the storage device 810 may be integrated together, or the communication interface 899 may be omitted if communication with another computer system is not required.

[0124] Specific implementation

[0125] In an exemplary embodiment, a drug administration device (e.g., Figure 1 Automatic injector 100, Figure 2Infusion pump 200, Figure 3 5 and any of the other drug administration devices described herein) is configured to electronically communicate data associated with the drug administration device to another device, such as Figure 7 The data may include any of a variety of types of information related to the drug administration device and / or the drug that can be dispensed from the drug administration device, such as data sensed by one or more sensors of the drug administration device. In this exemplary embodiment, other devices (e.g., Figure 7 The central computer system 700 of the invention, remote servers in a cloud computing architecture, and other computer systems described herein) is configured to use the data to help improve the patient's experience with the drug administration device, the patient's experience with the drug, other patients' experiences with drug administration devices of the same type as the drug administration device, other patients' experiences with the same drug, and / or other patients' experiences with different drugs. Figure 7 The central computer system 700 of the present invention, a remote server in a cloud computing architecture) is configured to analyze data received from the drug administration device in various ways to help achieve one or more of these goals, such as by any one or more of the following: correlating a patient's use of a drug with the patient's clinical outcome; performing a cost analysis that includes comparing the patient's clinical outcome with the clinical outcomes of other patients who received a different drug than the drug delivered to the patient via the drug administration device; comparing side effects experienced by the patient with side effects experienced by other patients who received a different drug than the drug delivered to the patient; determining whether the drug was delivered to the patient in compliance with the patient's treatment plan; identifying a failure in the administration of the drug; determining that additional data from the drug administration device is needed and triggering a request for additional data to be wirelessly transmitted from another device to the drug administration device; and performing predictive modeling of the patient's clinical outcome. Other devices (e.g. Figure 7 The central computer system 700, such as a remote server in a cloud computing architecture, may also be configured to receive data sensed by one or more sensors of each of a plurality of additional drug administration devices to increase the data set available for analysis and thereby improve the overall analysis by having a larger data set.

[0126] As mentioned above, a drug administration device may be used to deliver any of a variety of drugs. Examples of drugs that may be delivered using a drug administration device as described herein include (Infliximab), (Ustekinumab), (golimumab), Simponi (golimumab), (daratumumab), (guselkumab), (epoetin alfa), Risperdal (risperidone), Invega (paliperidone palmitate), (esketamine), ketamine, and Invega (paliperidone palmitate).

[0127] To other devices (such as Figure 7 A medication administration device that provides data to a central computer system 700 (e.g., a remote server in a cloud computing architecture) can provide any of a number of beneficial effects that cannot be easily or at all achieved in situations where the data is not available or collected in another manner. For example, manual reporting by a patient regarding the use of a medication administration device and / or medication results in information being conveyed that is delayed from the time of medication delivery and may not include all relevant information in sufficient detail due to the patient misremembering the details and / or the patient's inability to accurately view the information.

[0128] As another example, data may be communicated from a drug administration device to other devices (e.g., Figure 7 A central computer system 700, such as a remote server in a cloud computing architecture), can help ensure that other devices receive all relevant data in a predictable and timely manner.

[0129] As another example, data may be communicated from a drug administration device to other devices (e.g., Figure 7 The patient's electronic health record (EHR) and / or a form required for use with a specific medication (such as a patient monitoring form for a specific medication's Risk Evaluation and Mitigation Strategy (REMS) (e.g., a REMS for esketamine, ketamine, or other controlled substances)) can be automatically uploaded to the patient's central computer system 700, such as a remote server in a cloud computing architecture. Thus, the EHR and / or forms can be accurately and timely updated.

[0130] Figure 9One embodiment of a method 900 for updating a patient monitoring form using data sensed by one or more sensors and identifying one or more abnormal sensed parameters is shown. The patient monitoring form can similarly be updated using other data, such as data input into a user interface of a medication administration device. For example, psychological status data can be collected in various ways, such as via the patient's responses to questions in a questionnaire stored on an external device, via user input to one or more questions presented via the user interface of the medication administration device (such as responses to a psychological stress test such as the Kessler Mental Distress Scale (K10) or any of a variety of other indices and scales), healthcare provider assessment notes about the patient stored on an external device, and the like. The psychological status data can be used, for example, by a processor to assess when medication should be delivered from the medication administration device 500 to the user and to determine how the user is responding to current treatment. For example, a trend of improved mental status may indicate effective medication treatment for depression, necessitating a reduction in medication dosage and / or medication administration frequency. As another example, a trend of decreased mental status or stagnant mental status may indicate an increase in medication dosage and / or medication administration frequency for depression treatment.

[0131] In this illustrated embodiment, the sensed parameters include the patient's heart rate (HR), the patient's respiratory rate (RR), and the patient's blood pressure (BP), but as discussed herein, other conditions may be sensed. One or more sensors acquire 902 data, and the medication administration device communicates 904 the sensed data to the computer system 700 (or other device as discussed herein). The computer system 700 populates 906 the received sensed data into a temporarily stored patient monitoring form. For each of the sensed parameters, the computer system 700 determines whether the sensed data is above a predetermined maximum threshold or below a predetermined minimum threshold (as appropriate for the specific condition being measured). If not, the sensed data is deemed normal (e.g., within acceptable limits), and the computer system 700 populates 908 the patient monitoring form with the sensed data for that sensed condition. If yes, the sensed data is deemed abnormal (e.g., not within acceptable limits). The computer system 700 determines whether this abnormal determination is the first abnormal determination for this sensed parameter for this patient. If this abnormal determination is the first abnormal determination for this sensed parameter for this patient, the patient monitoring form has not yet been populated 908 with the sensed data. Conversely, after the parameter is sensed again 902, the computer system 700 receives the sensed parameter data and populates 906 the received sensed data into a temporarily saved patient monitoring form. If the computer system 700 determines that the sensed data is above a predetermined maximum threshold or below a predetermined minimum threshold (as appropriate for the specific condition being measured), thereby becoming a second instance of abnormal sensed data for the sensed condition, the computer system 700 causes 910 an alert to be provided to medical personnel (e.g., field staff with the patient using the medication administration device, the patient's healthcare provider, etc.) for evaluation and possible intervention. The alerted medical personnel confirms 912 the abnormal sensed data, for example, by manually reviewing the data on a display screen of the computer system 700, and causes the patient monitoring form to be populated 908 with the sensed data, for example, by providing an input to a user interface of the computer system 700 triggering the populating 908. Because human activity is involved, manual review of the sensed data by medical personnel and confirmation of abnormal sensed data can help to allow insurance reimbursement. If the computer system 700 determines that this sensed data is not above a predetermined maximum threshold or is not below a predetermined minimum threshold (as appropriate for the particular condition being measured), the first abnormality determination is deemed abnormal and the computer system 700 populates 908 the patient monitoring form with the sensed data for that sensed condition.

[0132] In other embodiments of method 900, the temporary save patient monitoring form can be eliminated. In such embodiments, the patient monitoring form will be filled 908 with all sensory data (even sensory data that is determined to be abnormal for the first time), which can provide a more complete patient record.

[0133] In other embodiments of method 900, medical personnel may be alerted to the first abnormal sensed condition, which may help allow medical intervention to be provided more quickly in an emergency situation.

[0134] As another example, data can be communicated from a drug administration device to other devices (e.g., Figure 7 In response to receiving the data, the other device may be configured to automatically trigger the mailing (or, as the case may be, alternative delivery) of a new drug administration device to the patient (or, as the case may be, another location for the patient to pick up and use), so that the new drug administration device is available for use before the next scheduled drug dose is expected and / or so that the patient has a limited supply of the drug on hand at any given time. Having a limited supply of the drug on hand at any given time may be particularly important for controlled substances that are potentially abused and / or more addictive than other drugs. In response to receiving the data, the other device may be configured to automatically trigger the mailing (or, as the case may be, alternative delivery) of one or more items in addition to or in place of the new drug administration device, such as an accessory configured for use before, during, and / or after drug administration (e.g., a questionnaire or other form to be completed by the user before, during, and / or after drug administration), an external device external to and separate from the drug administration device, and the like.

[0135] As another example, it may be difficult or impossible for a user of a drug administration device to detect some types of information, such as the precise amount of drug delivered to a patient in a single dose, the temperature of the drug, the GPS location of the patient when a dose of the drug was delivered to the patient, etc. However, as discussed herein, sensors of a drug administration device may be configured to sense information that is difficult or impossible for a user of the drug administration device to detect, and thus allow this data to be considered in analyses performed by other devices.

[0136] As another example, the drug administration device may be one of a plurality of drug delivery devices that deliver drugs to other devices (e.g., Figure 7A central computer system 700 (e.g., a remote server in a cloud computing architecture) provides the same one or more types of sensory data, thereby allowing other devices to predictably receive multiple data sets that can be compared to provide data to a healthcare professional. This data can be used to develop a patient treatment plan, modify an existing patient treatment plan, select medications for a patient, adjust the amount of time a patient should be monitored for side effects after medication administration, determine when multiple used medication administration devices are ready for pickup, determine when multiple medication administration devices have been at a location for a predetermined amount of time (e.g., one week, two weeks, one month, etc.) and are therefore ready for pickup regardless of use, and / or select medication administration devices for a patient. Some medication administration devices may require or be recommended to be picked up by an authorized agent after use for recycling and / or to help ensure that any medication remaining in the medication administration device (whether due to unused medication devices or residual medication remaining in the medication administration device after use) is securely disposed of and out of reach of unauthorized personnel, which may be particularly important with esketamine, ketamine, and other controlled substances. Picking up multiple medication administration devices at once is more efficient than picking up one medication administration device at a time. Administration of some medications (such as controlled substances and / or medications with known damaging side effects (such as drowsiness, sleep, etc.)) may require monitoring the patient for a minimum period of time (e.g., one hour, ninety minutes, two hours, four hours, etc.) after medication administration to help ensure that any side effects of the medication delivered from the medication administration device dissipate before the patient drives or otherwise (e.g., is driven by another person, walks, etc.) away from the location where the medication was administered, such that multiple datasets for multiple patients can help determine whether the minimum period of time is too long or too short for all patients. Similarly, multiple datasets for a particular patient can help determine whether the minimum period of time is too long or too short for a particular patient. Being able to reduce the minimum period of time for patient monitoring can improve the patient experience and / or reduce the time and / or cost burden on healthcare professionals and / or healthcare facilities.

[0137] In an exemplary embodiment, the drug administration device includes one or more sensors configured to monitor various data as described herein. In other embodiments, the drug administration device may include at least one of the sensors, and an external device external to and separate from the drug administration device may include at least one of the sensors. Generally, the external device includes a computer system as described herein and includes a communication interface, similar to the communication interface of the drug administration device configured to communicate with system 700. Some external devices are designed specifically for communication with the drug administration device, while other external devices (e.g., smartphones, smartwatches, heart rate monitors, blood glucose monitors, blood pressure monitors, etc.) only allow other devices (such as system 700) to communicate with them. The external device including at least one of the sensors helps offload some of the data collected and transmitted from the drug administration device and / or may enable sensing capabilities that would otherwise be unavailable if only the sensors of the drug administration device were used. In other embodiments, the external device includes one or more sensors. The external device including one or more sensors offloads data collected and transmitted from the drug administration device and / or enables sensing capabilities that would otherwise be unavailable if only the sensors of the drug administration device were used.

[0138] The sensors described herein may be configured to collect data regarding various conditions, such as device conditions (e.g., as sensed by device sensor 92), environmental conditions (e.g., as sensed by environmental sensor 94), and location conditions (e.g., as sensed by location sensor 98). Examples of conditions include: geographic location (e.g., as sensed by a location sensor configured to sense a GPS or other location), time (e.g., as sensed by a timer or clock device (such as an atomic clock)), date (e.g., as sensed by a timer), temperature (e.g., as sensed by a temperature sensor), ultraviolet (UV) exposure (e.g., as sensed by a UV sensor configured to sense UV levels), humidity (e.g., as sensed by a humidity sensor configured to sense humidity levels), pressure (e.g., as sensed by a pressure sensor), angular rate (e.g., as sensed by an inertial measurement unit (IMU) or a MARG (magnetic, angular rate, and gravity) sensor), body orientation (e.g., using an IMU), and other data used to deliver the data. The sensor may include a current sensor, a blood oxygen sensor, a sun exposure sensor, a UV sensor, etc., an osmotic pressure sensor, a blood glucose monitor, etc., a blood glucose monitor, etc., a blood pressure sensor, a blood pressure monitor, etc., a perspiration sensor, etc., a heart rate sensor, a heart rate monitor, etc., a respiratory rate sensor, a respiratory rate sensor, a heat sensor configured to be located near the nose or mouth and to detect heat or to detect in / out air flow movement during exhalation, a pressure sensor configured to be located near the nose or mouth and to detect pressure or to detect in / out air flow movement during exhalation, a spirometer, etc., and an air quality sensor, etc. In various embodiments, the sensor includes an image capture device, such as a camera, and the processor is configured to analyze images and / or video captured by the image capture device, such as analyzing patient breathing, patient eye dilation, patient sedation, patient dissociation, patient voice characteristics (such as tone and pitch), any food intake, and / or patient skin reaction to the medication. Image capture devices are further described in U.S. Patent Publication No. 2012 / 0330684, entitled “Medication Verification And Dispensing,” published on December 27, 2012, which is incorporated herein by reference in its entirety.U.S. Patent Publication No. 2002 / 0014951, entitled “Remote Control For A Hospital Bed,” published on February 7, 2002, and U.S. Patent Publication No. 2007 / 0251835, entitled “Subnetwork Synchronization And Variable Transmit Synchronization Techniques For A Wireless Medical Device Network,” published on November 1, 2007, further discuss various sensors and are incorporated herein by reference in their entirety.

[0139] Using the drug administration device 500 of FIG5 as an example, for clarity and ease of describing the embodiments provided herein, the drug administration device 500 can be configured to automatically transmit data indicating information sensed by one or more sensors 92, 94, 98 of the device according to a predetermined schedule, such as transmitting data every hour, every three hours, every twelve hours, once a day, whenever the device 500 delivers a dose, every other time the device 500 delivers a dose, etc. In this way, the system 700 can receive data regularly for analysis, and neither the user of the device 500 nor the system 700 need to be prompted to transmit the data. The predetermined schedule can be programmed into the memory 97 of the drug administration device, in which case the device 500 transmits the data without a prompt from the system 700, or the predetermined schedule can be programmed into the system 700, in which case the system 700 transmits a request for data to the device 500, which transmits the data in response to the system 700. In an exemplary embodiment, the predetermined schedule is the same for all sensed data, which can help save device power and resources, but the predetermined schedule can be different for data monitored by different sensors 92, 94, 98 of the device 500, which can help the system 700 have more time available for analysis.

[0140] In some embodiments, the predetermined schedule can be immutable, such that the predetermined interval between data transmissions is always the same, which can help ensure predictable data collection. In some embodiments, the predetermined schedule can be variable, such that the predetermined interval between data transmissions can be changed over time, which can help analyze and / or react to unexpected data. If any of the data is above a predetermined maximum threshold or below a predetermined minimum threshold (as appropriate for the specific condition being measured), the schedule can be configured to automatically change to reduce the predetermined interval between data transmissions, at least for the data determined to be above the predetermined maximum threshold or below the predetermined minimum threshold. Thus, data can be received more frequently, which can allow for faster identification of out-of-range data as "abnormal" readings that are not cause for concern, and faster identification of problematic trends that should be communicated to the patient and / or medical staff for action, as appropriate. For example, a patient's blood pressure measurement may be above a predetermined maximum threshold blood pressure value, triggering a change in the predetermined interval, so that the new blood pressure data is transmitted earlier than data that would have otherwise been received and analyzed. For another example, a patient's heart rate measurement may fall below a predetermined minimum threshold heart rate value, thereby triggering a change in the predetermined interval, such that new heart rate data is transmitted earlier than previously received and analyzed data. For another example, a patient's respiration rate measurement may fall below a predetermined minimum threshold respiration rate value, thereby triggering a change in the predetermined interval, such that new respiration rate data is transmitted earlier than previously received and analyzed data.

[0141] In addition to or as an alternative to the medication administration device 500 being configured to automatically transmit data indicative of information sensed by one or more of the device's sensors 92, 94, 98, the medication administration device 500 may also be configured to transmit data to the system 700 on demand in response to requests for data from the system 700 to the device 500. Transmitting data on demand may help conserve device power and resources and / or may help ensure that the system 700 receives only the data it needs to perform a particular analysis. The system 700 may be configured to transmit requests to the device 500 according to a predetermined schedule (e.g., transmitting data every hour, every three hours, every twelve hours, once a day, etc.), and / or may be configured to transmit requests in response to a user input request to the system 700 querying the device 500 for sensed information. Similar to the discussion above regarding the medication administration device 500 being configured to transmit data according to a variable or immutable schedule, the schedule for transmitting requests from the system 700 to the device 500 may be variable or immutable.

[0142] In addition to or as an alternative to the drug administration device 500 being configured to automatically transmit data indicative of information sensed by the device's one or more sensors 92, 94, 98, the drug administration device 500 can be configured to transmit data to the system 700 on demand, for example, following user input to the system 700 via the drug administration device's user interface 80. Transmitting data on demand can help ensure that the system 700 receives timely data to perform specific analyses. The system 700 can be configured to transmit requests to the device 500 according to a predetermined schedule (e.g., transmitting data every hour, every three hours, every twelve hours, once a day, etc.), and / or can be configured to transmit requests in response to user input to the drug administration device 500. User input to the drug administration device 500 may indicate that the patient is experiencing side effects after drug delivery and wishes to consult a healthcare professional. In other embodiments including at least one external device, the user input can alternatively be provided to the external device.

[0143] System 700 can be configured to store data received from device 500 for analysis at a later time. For example, system 700 can be configured to perform analysis on demand in response to user input to system 700 requesting one or more types of analysis (such as any one or more of the analyses discussed further below). Performing analysis on demand can help conserve system power and resources and / or can help ensure that the user receives analysis output from system 700 based on the most current data available to system 700. As another example, system 700 can be configured to automatically perform analysis according to a predetermined schedule (e.g., analyzing data every hour, every three hours, every twelve hours, once a day, whenever system 700 has received a predetermined number of data transmissions from device 500 so that there is a sufficient amount of new data to include in the analysis, etc.). Additionally or alternatively, system 700 can be configured to perform analysis in response to receiving data from device 500 (e.g., performing analysis whenever system 700 receives a particular type and / or a particular amount of data from device 500, etc.). Receipt of data as a trigger for analysis may help identify problems with the medication administration device 500 and / or medication more quickly, which in turn may allow a medical professional and / or user of the device 500 to resolve the problem more quickly.

[0144] Generally speaking, the analysis performed by the system 700 uses sensed information from a drug administration device 500 (and, in at least some analyses, one or more additional drug administration devices 500). In an exemplary embodiment where the system 700 is analyzing data received from multiple devices 500, each of the devices 500 is of the same type (e.g., each is the same type of autoinjector, inhaler, infusion pump, nasal spray device, etc.), delivers the same type of medication, and / or delivers the same medication. Thus, the analyzed data can yield significant, meaningful results related to a specific type of drug administration device, a specific type of medication, and / or a specific medication. The data collected by the system 700 from multiple devices 500 can each indicate the same type of sensed information, such as medication temperature information, GPS information, dose timing information, etc. Collecting the same type of information from multiple devices 500 can allow the system 700 to continuously review the data and identify trends in the data across patients, and correlate these trends with patient type, drug administration device type, and functional outcomes. These relationships can be evaluated by system 700 through various algorithms to provide more accurate trends and / or more accurate recommendations, such as recommendations to treat patients and their symptoms that result in optimized outcomes, recommendations that result in cost savings, recommendations that result in fewer and / or less severe side effects, etc.

[0145] Generally, data transmitted from the medication administration device 500 and / or medication housing 630 via the network 702 may be received by the system 700. The transmitted data may be aggregated and processed by the system 700. Data including patient medical record data, physician summary data, medication specification data, and financial data associated with the cost of providing care to the patient may be shared via the network 702 and aggregated by the system 700 for use in determining and predicting clinical outcomes.

[0146] In one embodiment, the system 700 can be configured to receive data transmitted from the drug administration device 500 and process the data to correlate the patient's use of the drug with clinical outcomes. Clinical outcomes generally include measurable changes in health status, function, or quality of life that can occur as a result of clinical treatment (such as administering a drug or receiving therapeutic treatment). Clinical outcomes can be determined based on data received from the patient in response to prompts (such as self-report assessments in questionnaires or other similar formats). Clinical outcomes can also be determined based on data collected from the patient and provided by a healthcare practitioner. Clinical outcome data can be stored in a database such as a patient's medical file, a hospital information system, etc., and can be transmitted to and / or stored in the memory of the system 700. Although the foregoing describes the collection of clinical outcome data as input to a form or questionnaire (such as a health assessment form that can be implemented on an application configured on a mobile computing device) via patient self-report or by a healthcare provider, those skilled in the art will understand that clinical outcome data can be captured in other ways, and devices other than mobile computing devices can be used to collect clinical outcome data with or without running an application. Those skilled in the art will understand that data can be captured in a variety of ways, such as using a camera (either standalone or integrated into another device (such as a mobile phone or tablet computer)); a video camera (standalone or integrated into another device (such as a mobile phone or tablet computer)); one or more sensors (e.g., a gyroscope, an accelerometer, a global positioning system (GPS), an imager (e.g., a camera or video camera), etc.), located on a smart phone, in a skin patch (e.g., a patch available from MC10 Inc. of Cambridge, Massachusetts), integrated into smart clothing, or in another sensing or monitoring device that can be connected to the drug administration device 500 or system 700 via a wireless or wired connection; and any of a variety of known motion capture applications or motion capture software; etc. Additional information regarding clinical outcomes and collected patient data is provided in U.S. Patent Publication No. 2014 / 0081659, entitled “Systems and Method for Surgical and Interventional Planning, Support, Post-operative Follow-up, and Functional Recovery Tracking,” published on March 20, 2014, which is hereby incorporated by reference in its entirety.

[0147] Once received by the system 700, the clinical outcome data may be aggregated with data received from the drug administration device 500 and / or the medication housing 630. The system 700 may analyze the aggregated data to identify trends and correlations that may exist between the drug and drug administration data and the clinical outcome data received from the drug administration device 500 and / or the medication housing 630. Additionally, the system 700 may receive data from one or more additional drug administration devices 500 and / or medication housing 630 to identify trends and correlations between patient populations.

[0148] Such correlations can be determined, for example, by a server configured within system 700 to include one or more data processing components, each associated with a data processor that implements artificial intelligence and machine learning systems. Machine learning is an application of artificial intelligence that automates the development of predictive models by using algorithms that iteratively learn patterns from data without explicit instructions for the data patterns. Machine learning is commonly used in pattern recognition, computer vision, language processing, and optical character recognition, and enables the construction of algorithms that can accurately learn from data to predict model outputs, thereby making data-driven predictions or decisions. Machine learning can be used to develop predictive models that can generate clinical outcomes associated with one or more aspects of patient treatment, such as patient use of a drug administration device and patient compliance with a specific drug delivery schedule.

[0149] The artificial intelligence and machine learning systems configured within system 700 may include one or more predictive models or algorithms that have been trained in a machine learning process or implement a layered structure of deep learning algorithms (also known as artificial neural networks). These predictive models or algorithms can continuously analyze data using the artificial neural network and generate predictions. System 700 can perform untrained or deep learning to predict clinical outcomes based on device usage and drug delivery data received from drug administration device 500 and / or drug housing 630 (and / or additional drug administration devices 500 and / or drug housings 630). In this way, features of device usage or drug delivery data can be used to accurately predict specific clinical outcomes. For example, an artificial neural network can process insulin syringe usage data for a diabetic patient that indicates the patient is reasonably compliant with the prescribed twice-daily insulin delivery schedule and determine a predicted clinical outcome indicating that the patient is unlikely to receive a protective reduction in elevated blood glucose levels. Additional information regarding specific implementations of neural networks is provided in U.S. Patent Publication No. 2018 / 0189638, entitled “Hardware Accelerator Template Design Framework For Implementing Recurrent Neural Networks,” published on July 5, 2018, which is hereby incorporated by reference in its entirety.

[0150] The artificial intelligence and machine learning system configured within system 700 may include data processing components, each associated with a data processor to perform trend analysis that can identify trends and changes in device usage and drug delivery data over time. The trend analysis can include time series data associated with how self-reported or predicted clinical outcomes change over time. The trend analysis can be compared to expected or predetermined patterns in the device usage and drug delivery data and expected or predetermined patterns in the clinical outcome data. Such determinations can be made regarding compliance with drug administration over time and the expected clinical outcomes that can be generated based on the compliance determination. Assessing adherence can thus allow monitoring and management of a patient's treatment, which can help the patient's physician (and / or other medical professionals) assess the patient's medical progress and / or can help determine whether and when the patient's treatment plan may need to be modified, such as by adjusting the treatment plan (e.g., changing the dose size of the drug delivered from the drug administration device 500, changing the timing of the doses delivered by the drug administration device 500, changing dietary requirements, changing the frequency of physician visits, changing the amount of patient monitoring time required after delivery of a drug dose, allowing the patient to receive drug doses at home rather than only under medical supervision at a hospital or other healthcare facility, etc.) or replacing the treatment plan (e.g., a treatment plan that includes use of the drug administration device 500 that delivers a specific drug) with another treatment plan (e.g., a treatment that does not include any use of the drug administration device 500 and / or a specific drug). Additional information regarding adherence determination is provided in previously mentioned U.S. Patent Publication No. 2014 / 0081659, published on March 20, 2014, entitled “Systems And Methods For Surgical And Interventional Planning, Support, Post-Operative Follow-Up, And Functional Recovery Tracking.”

[0151] For example, a patient's adherence data (e.g., data indicating when the patient received a dose from the drug administration device 500 compared to when the dose was prescribed according to the patient's treatment plan) can be compared to historical adherence data for other patients who used the same type of drug administration device 500 and / or received the same medication to help determine the effectiveness of the drug administration device 500 and / or medication for the patient. This comparison can allow the system 700 to determine whether the patient is adequately adhering to the treatment plan or lagging behind historical benchmarks achieved by other patients undergoing treatment. This comparison can also allow the system 700 to evaluate treatment options for future patients because if a treatment has historically been shown to be problematic for any one or more reasons (e.g., difficulty achieving patient adherence, slow progress in resolving symptoms, cost, lack of insurance coverage, etc.) or has been shown to be particularly effective for any one or more reasons (e.g., drug dose size decreases over time, drug use decreases or is ultimately eliminated, etc.), the system 700 is more likely (for particularly effective treatments) or less likely (for problematic treatments) to recommend the treatment to the future patient.

[0152] Because the system 700 can be configured to simultaneously and continuously receive information about multiple patients from multiple drug administration devices 500, the system 700 can repeatedly analyze the received data to help determine the efficacy of a particular patient's treatment plan, including use of the same type of drug administration device 500 and / or the same medication as other patients. The system 700 can therefore determine that the treatment plan for a particular patient should be modified based on data from another group of patients indicating low or high effectiveness of that type of drug administration device 500 and / or medication. In other words, the system 700 can learn from the experiences of other patients that the current patient's treatment could benefit from modifications, such as using a different type of drug administration device 500 with a lower failure rate and / or higher compliance rate, prescribing a different medication, increasing or decreasing the frequency of dosing, reducing the amount of patient monitoring time required after a drug dose is delivered, etc. The system 700 can be configured to recommend modifications to the patient's treatment plan to the patient's healthcare provider, for example, by providing the healthcare provider with an alert indicating that a modification to the patient's treatment plan is recommended. The healthcare provider can review the modification, for example, by logging into the system 700 and / or computer system with which it communicates, and determine whether to modify the patient's treatment plan. Alternatively, the system 700 can be configured to automatically modify the patient's treatment plan and notify the patient and / or the patient's healthcare provider via an alert regarding the modified treatment plan. However, typically, before the system 700 automatically modifies the patient's treatment plan and notifies the patient of the change, the healthcare provider will review the modification to check its suitability for the particular patient.

[0153] The artificial intelligence and machine learning system configured within system 700 may include data processing components, each associated with a data processor, to monitor the effectiveness of drugs delivered via drug administration device 500 and / or drug housing 630 (and / or additional drug administration devices 500 and / or drug housings 630). In at least some embodiments, system 700 may be configured to process device usage and drug delivery data that has been aggregated with clinical outcome data to determine the extent to which a drug provides a therapeutic benefit and whether the drug causes a patient to experience any side effects that can be reported via clinical outcome data. For example, system 700 may determine a correlation between a particular drug (or a particular drug delivery schedule) and self-reported nausea symptoms. System 700 may further process data associated with an individual patient's medical history to determine an appropriate dosage or delivery schedule that is less likely to cause nausea. In this way, new drugs or drug delivery regimens that produce desired clinical outcomes for a patient population may be identified. For another example, system 700 may determine that patients receiving a drug different from the drug delivered to the patient do not experience side effects experienced by patients receiving the drug and / or experience less severe side effects than patients receiving the drug. Thus, the system 700 may determine that a medication received by another patient would be a good alternative for recommending to the patient receiving the medication in an effort to prevent the patient from experiencing side effects or to reduce the severity of the side effects. For another example, the system 700 may determine that a particular patient has experienced one or more side effects (e.g., drowsiness, nausea, vomiting, etc.) of a particular medication during patient monitoring but after the amount of patient monitoring time required after the delivery of each of a plurality of medication doses has elapsed. Thus, the system 700 may determine that for a particular patient, the amount of patient monitoring time required after the delivery of a dose of a particular medication should be increased. For another example, the system 700 may determine that a particular patient has experienced one or more side effects (e.g., drowsiness, nausea, vomiting, etc.) of a particular medication at a certain time during the amount of patient monitoring time required after the delivery of a medication dose, but after a certain time point has elapsed. Thus, the system 700 may determine that for a particular patient, the amount of patient monitoring time required after the delivery of a medication dose should be reduced. For another example, the system 700 may determine that any patient has experienced one or more side effects (e.g., drowsiness, nausea, vomiting, etc.) of a particular medication at a certain time during the amount of patient monitoring time required after the delivery of a medication dose, but after a certain time point has elapsed. Thus, the system 700 may determine that the amount of patient monitoring time required after delivery of a dose of a particular drug should be reduced for all patients. For another example, the system 700 may determine that many patients have experienced one or more side effects of a particular drug (e.g., drowsiness, nausea, vomiting, etc.) during patient monitoring but after the amount of patient monitoring time required after delivery of a dose of the drug. Thus, the system 700 may determine that the amount of patient monitoring time required after delivery of a dose of the particular drug should be increased for all patients.

[0154] In some embodiments, the system 700 can be configured to electronically transmit instructions based on the system's analysis of previously received data to the drug administration device 500 and / or the drug housing 630. The drug administration device 500 and / or the drug housing 630 can be configured to execute the received instructions on the drug administration device 500 and / or the drug housing 630 to change at least one aspect of the functionality of the device / housing. Thus, the system 700 can be configured to remotely control the drug administration device 500 and / or the drug housing 630.

[0155] For example, instructions from the system 700 may include a request for the device 500 or housing 630 to change a predetermined schedule upon which, in embodiments where the predetermined schedule is programmed into the memory 97 of the drug administration device 500 or the drug housing 630, data sensed by the one or more sensors is transmitted to the system 700. The request may be sent on demand, such as because a physician or other medical professional reviewing information collected by the system 700 about the drug administration device 500 or the drug housing 630 may desire more frequently sensed information to facilitate the physician's or other medical professional's analysis of the patient's treatment plan and, therefore, input a request to the system 700 for the system 700 to update the device / housing's stored predetermined schedule. The request may be sent automatically, such as in response to received data being above a predetermined maximum threshold or below a predetermined minimum threshold, as discussed above.

[0156] For another example, instructions from system 700 may include a request for the drug administration device 500 or drug housing 630 to modify drug delivery functionality, such as a drug delivery schedule, drug injection rate, and delivered dose. A physician or other medical professional reviewing information collected by system 700 regarding the drug administration device 500 or drug housing 630 may desire to modify drug delivery functionality based on the information reviewed. More specifically, an algorithm stored in memory 97 of the drug administration device 500 or drug housing 630 may be executable by the processor 96 on the drug administration device or drug housing to administer a dose of the drug to a patient. The algorithm is stored in the form of one or more sets of multiple data points defining and / or representing instructions, notifications, signals, etc., to control device functionality and drug administration. Data received by the drug administration device 500 or drug housing 630 via a communication interface thereof, for example, as multiple data points, is used by the processor 96 to modify at least one variable parameter of the algorithm based on the received instructions, identifying the parameter to be modified and the updated value of the parameter. At least one variable parameter is included among the data points of the algorithm, for example, in the instructions for drug delivery, and thus each variable parameter can be changed by changing one or more of the plurality of data points stored in the algorithm. After the at least one variable parameter has been changed, subsequent executions of the algorithm administer another dose of the drug according to the changed algorithm. Thus, drug delivery can be remotely managed over time for a patient, for example, by a healthcare professional providing input to the system 700 for changes in drug delivery, to increase the beneficial outcomes of the drug. Changing the at least one variable parameter and / or administering one or more doses is itself automated to improve patient outcomes. Thus, the system 700 can be configured to facilitate personalized medication based on the patient to provide an intelligent system for drug delivery.

[0157] The artificial intelligence and machine learning system configured within system 700 may include a data processing component configured to receive financial data associated with the cost of providing healthcare to a patient. The received financial data can be used to analyze the cost-effectiveness of various medications or therapeutic regimens that can be prescribed for a particular patient. The financial data includes payer, insurance, and / or hospital cost data that, when analyzed with respect to device usage and drug delivery data and clinical outcome data, can provide insights into lower-cost drug alternatives that produce substantially the same clinical outcomes as the drug. For example, a particular drug may be associated with a lower insurance reimbursement rate and / or lower hospitalization costs than another drug, where each drug in the drug group is used to treat the same medical problem (e.g., blood pressure, asthma, etc.) and each drug has substantially similar clinical outcomes associated with each drug. Thus, system 700 can identify drugs with higher insurance reimbursement rates and / or higher hospital cost rates as more financially reasonable options for patients currently receiving other drugs as part of their treatment plan. One skilled in the art will understand that clinical results may not be exactly the same, yet still be considered substantially the same as one another for a number of reasons, such as due to statistical standard deviations.

[0158] System 700 can be configured to use the aggregated data to perform predictive modeling of drug delivery compliance and resulting clinical outcomes for a specific patient based on hypothetical parameters that can be provided to the system 700 by the patient's physician and / or other healthcare provider. The artificial intelligence and machine learning systems configured within system 700 may include data processing components configured to implement a machine learning process that is trained to generate a predictive model capable of receiving input parameters associated with device usage or drug delivery data and predicting clinical outcomes based on these inputs. Once trained during the training phase of the machine learning process, the predictive model can be deployed as a trained predictive model within system 700 and accessed via a user interface (such as a web-based application configured on a web browser of a computer system at a medical facility 706) or via a user interface (such as an application configured on a smartphone or other mobile computing device at a mobile location 710). The interface of the trained predictive model can allow a user to input data parameters associated with a specific treatment modality for a specific patient. These input parameters may include, for example, any one or more parameters related to a drug delivery schedule, drug dosage, drug type, device type, etc. The trained predictive model can process the inputs and provide the user with predicted clinical outcomes, predicted side effects, and / or other predicted behavioral or physiological changes that are predicted as symptoms for a particular patient based on the inputs. In this way, the system 700 can enhance the ability of a physician or other healthcare provider to evaluate various drug delivery schedules and alternative configurations of the drug administration device 500 in a controlled, low-risk manner before administering a new treatment regimen to a patient.

[0159] System 700 can be configured to receive data transmitted from medication administration device 500 and process data and metadata associated with a healthcare professional's summary of a patient's treatment over time, as recorded in a patient's medical history file. System 700 can be configured to receive physician summary data or metadata from a hospital information system when the physician summary data is entered into a patient's medical history file. System 700 can be configured to analyze the physician summary data relative to data transmitted from medication administration device 500, so that patient compliance with a prescribed medication regimen or therapeutic treatment can be determined in real time or near real time. In this way, compliance trend analysis and reporting can be performed more quickly than in systems that may not receive device usage and medication delivery data or that may not integrate healthcare professional summary data, as configured in system 700.

[0160] Receiving the physician summary data when it is recorded in the patient's medical history file (e.g., in the patient's EHR) and / or the patient's patient monitoring form allows the system 700 to generate notifications as soon as a non-adherence condition is determined. The notifications can be generated as alerts or alarms that can be transmitted to one or more computer systems to inform the patient, the patient's physician, and / or other appropriate medical professionals that the patient is experiencing a non-adherence issue or other medical condition that requires immediate attention. The notifications can enable the physician and / or appropriate medical professionals to quickly initiate actions to mitigate or reduce the non-adherence condition.

[0161] In at least some embodiments, the system 700 may include one or more data filters that may be applied to the physician summary data that has been aggregated with the data transmitted from the drug administration device 500. The data filters may include, for example, parsing the aggregated data based on geographic region, age, genetic profile, and / or ethnicity so that significant trends associated with the patients included in the filtered data may be determined.

[0162] The system 700 may be configured to receive data transmitted from the drug administration device 500 and automatically and in real time or near real time process the data to determine complaints associated with the device 500. The system 700 may process the received device usage data to determine a malfunction of the device 500 and, based on the malfunction, may generate a complaint. For example, Figure 1 The device usage data received from the drug administration device 100 may indicate to the system 700 that the discharge nozzle 122 failed to extend out of the housing 130 during the injection sequence and therefore failed to deliver the drug to the patient. Figure 1Device usage data received by the drug administration device 100 can indicate to the system 700 that a user error that affects drug delivery has occurred, such as the time between two nasal sprays being too short so that the first nasal spray cannot be adequately absorbed, the needle of the autoinjector being removed from the patient too soon after drug delivery begins so that the patient may not have received the full intended amount of drug, the drug not being given sufficient time to warm to room temperature after being removed from the refrigerator, etc. A complaint can be generated as an alert or alarm that is transmitted to one or more computer systems to inform the patient, the patient's physician, and / or other appropriate medical professionals of the device malfunction. Based on the generated complaint, the system 700 can further notify the manufacturer of the drug administration device of the device malfunction and request that a new drug administration device be configured and provided directly to the patient and / or to another location. Embodiments of interfaces that may be used to provide alerts or alarms are further described in U.S. Patent Publication No. 2008 / 0154177, entitled “System And Method For Remote Monitoring And / Or Management Of Infusion Therapies,” published on June 26, 2008, which is hereby incorporated by reference in its entirety.

[0163] The system 700 can be configured to generate a fault report that is pre-populated with patient-specific device data describing the configuration of the malfunctioning drug administration device. In this way, the system 700 can help diagnose quality assurance issues with the device while ensuring that the patient can maintain the prescribed medication delivery schedule for these quality assurance issues using a functioning drug administration device that can be provided as a replacement for the malfunctioning device.

[0164] System 700 may be configured to provide a system for receiving data from a remote location such as Figure 7The system 700 may also respond to a request for additional data received from a user at a remote location (e.g., a mobile location 710). A user at a remote location (e.g., a physician or other medical professional providing care to a patient) may desire the additional data for any of a variety of reasons, such as wanting the system 700 to receive and analyze more current information from a single medication administration device 500 or multiple medication administration devices 500 to better understand specific trends in the system 700, previous cost conclusions, or other a priori analytical outputs, to trigger the collection of specific types of data not previously received by the system 700 so that such data can be included in the system's analysis to help determine whether an identified failure of a specific medication administration device 500 is unique to that device 500 or may be a problem with a group of related medication administration devices 500, etc. For example, the request for additional data may include a request for data associated with a specific patient's medication administration device 500 or the configuration of the patient's device 500, such as specifications for a specific medication contained within the device 500 or a specific component within the device 500. For example, a request for additional data may include a request for data associated with a particular class of drug administration devices (including the patient's device 500), such as the device model number, manufacturing batch number, and data identifying or otherwise associated with a patient population to which the drug administration device 500 has been prescribed. As another example, a request for additional data may include a request for data associated with a particular drug that may be administered by the drug administration device 500 or the class of drug administration devices including the patient's device 500, such as the drug formulation, dosage data, drug type or class, and characteristics associated with the administration method of the drug administration device 500, which characteristics may include, for example, the viscosity of the administered drug in the case of a syringe-type device.

[0165] System 700 can be configured to aggregate data received from drug administration device 500 with clinical outcome data to detect irregular treatment conditions for a specific treatment modality that has been prescribed using a specific configuration of drug administration device 500. For example, irregular treatment conditions include irregular dosing events, non-prescribed dosing timed intervals, and indicators of negative clinical outcomes. System 700 can use the aggregated data to identify when a specific treatment modality is being administered outside of the prescribed or expected treatment parameters and can generate recommendations that may improve the clinical outcomes experienced by the patient. When system 700 determines that an irregular treatment condition is associated with a better-than-expected clinical outcome, the generated recommendations may include actions to be performed. For example, if system 700 determines that a patient's irregular treatment condition resulted in an improved clinical outcome, system 700 may mark the improved clinical outcome in a database and may initiate a search for data that may support or refute the unexpected improvement in the clinical outcome. System 700 can be configured to analyze the search results, for example, using natural language processing. If the system 700 determines that the irregular treatment condition supports improved clinical outcomes, the system 700 may forward the search results to predetermined personnel for further consideration to include aspects of the irregular treatment condition as modifications to the particular treatment modality or particular configuration of the drug administration device 500 .

[0166] When system 700 determines that an irregular treatment condition is associated with a worse-than-expected clinical outcome, the system-generated recommendations may include actions to be performed. For example, if system 700 determines that a patient's irregular treatment condition is leading to a worse or negative clinical outcome, system 700 may generate a notification to the patient and / or the patient's healthcare professional, informing each of these individuals that an improved treatment or configuration of drug administration device 500 is available that may lead to the expected or improved clinical outcome. For example, the notification may recommend changing the dosing interval from once daily to twice daily. Additionally, the notification may include various means or affordances to facilitate a conversation between the patient and their healthcare provider regarding the irregular treatment condition and the resulting negative clinical outcome. The notification to the patient's healthcare professional may include details of the originally prescribed treatment regimen and the corresponding configuration of drug administration device 500 for the specific treatment regimen. The notification to the patient's healthcare professional may also include the expected clinical outcome for the specific treatment regimen originally prescribed.

[0167] All devices and systems disclosed herein can be designed to be discarded after a single use, or can be designed for multiple uses. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of disassembly of the device, subsequent cleaning or replacement of specific parts, and subsequent reassembly. Specifically, the device is removable, and any number of specific parts or components of the device can be selectively replaced or removed in any combination. After cleaning and / or replacement of specific components, the device can be reassembled for subsequent use at a reconditioning facility or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning devices can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting reconditioning devices are within the scope of this application.

[0168] It may be preferred to sterilize the devices disclosed herein prior to use. This can be accomplished by any number of means known to those skilled in the art, including beta or gamma irradiation, ethylene oxide, steam, and liquid baths (e.g., cold soaks). Exemplary embodiments for sterilizing devices including internal circuitry are described in more detail in U.S. Patent Publication No. 2009 / 0202387, published on August 13, 2009, and entitled "System And Method Of Sterilizing An Implantable Medical Device." It is preferred that the device be hermetically sealed if implanted. This can be accomplished by any number of means known to those skilled in the art.

[0169] The present disclosure has been described above by way of example only in the context of the overall disclosure provided herein. It will be understood that modifications may be made within the spirit and scope of the claims without departing from the overall scope of the present disclosure.

Claims

1. A drug administration system, comprising: a plurality of drug administration devices, each drug administration device configured to deliver at least one dose of a drug from the drug administration device to a different one of a plurality of patients, each of the plurality of drug administration devices comprising a sensor configured to sense information related to at least one of the drug administration device and the drug, and each of the plurality of drug administration devices comprising a communication interface configured to wirelessly transmit data indicative of the sensed information; as well as a server comprising a communication interface configured to wirelessly receive the data transmitted by the communication interface of the drug administration device, and the server comprising a processor configured to perform predictive modeling of a clinical outcome for the patient, wherein the processor is further configured to determine that a treatment plan for a patient should be modified based on data received from at least one of the other patients.

2. The system of claim 1 , wherein the processor is configured to use the data in at least determining whether the medication was delivered to a patient of the plurality of patients in compliance with the patient's treatment plan, and the processor is further configured to use the determination of whether the medication was delivered to a patient of the plurality of patients in compliance with the patient's treatment plan in at least one of: generating an alert to a physician indicating said patient's compliance, determining trends in said patient's compliance, determining trends in treatment plan adherence within a specific population group comprising the patient and a plurality of additional patients, each patient in the specific population group sharing a common attribute comprising at least one of age, race, and genetic profile, and A trend in treatment plan adherence is determined in a region-specific population group comprising the patient and a plurality of additional patients.

3. The system of claim 1, wherein each of the plurality of drug administration devices is configured to administer the same drug to each of the plurality of patients.

4. The system of claim 1 or 3, wherein each of the drug administration devices is selected from the group consisting of: a syringe, a syringe, an inhaler, a nasal spray device, and an infusion pump.

5. The system of claim 1 or 3, wherein the processor is configured to use the data in correlating the patient's use of the drug with the patient's clinical outcome, and the processor is further configured to do at least one of the following: identifying trends in patient outcomes among the plurality of patients, and The plurality of patients are monitored for side effects of the drug.

6. A system according to claim 1 or 3, wherein the processor is configured to use the data in at least performing a cost analysis, and the processor is further configured to identify a second drug that has a lower cost than the drug and is associated with a clinical outcome that is substantially the same as the clinical outcome of the patient.

7. The system of claim 1 or 3, wherein the processor is configured to use the data in at least determining whether the medication was delivered to the patient in compliance with the patient's individual treatment plan, and the processor is further configured to use the determination of whether the medication was delivered to the patient in compliance with the patient's individual treatment plan in at least one of: generating an alert to a physician indicating at least one of the patient's compliance, and A trend in the patient's compliance is determined.

8. The system of claim 1 or 3, wherein the processor is configured to use the data in at least identifying a failure in any of the administrations of the medication, the failure comprising an inability to administer the medication, and the processor is further configured to trigger an action causing each of the patients associated with the failed medication administration device to receive a new medication administration device.

9. A system according to claim 1 or 3, wherein the processor is configured to use the data in at least identifying a failure in any of the administrations of the drug, the failure comprising a user error in drug delivery, and the processor is further configured to trigger an alert indicating the identified failure.

10. A system according to claim 1 or 3, wherein the processor is configured to use the data in at least identifying a failure in any of the administrations of the drug, the failure comprising an irregularity in any of the administrations being at least partially delivered, and the processor is further configured to correlate the irregularity with the patient's clinical outcome to determine whether the patient's clinical outcome is better than the clinical outcomes of other patients who received the drug.

11. The system of claim 1 or 3, wherein the processor is configured to use the data upon at least determining that additional data is needed from any of the drug administration devices and triggering a request for the additional data to be wirelessly transmitted from the communication interface of the server, and the additional data includes at least one of a model number of the drug administration device, a batch number of the drug administration device, a size of a dose size, a type of the drug, and a viscosity of the drug when the drug is administered.

12. The system of claim 1 or 3, wherein the processor is configured to use the data in predictive modeling of at least the patient's clinical outcome, and the processor is further configured to use physician-input data about the patient in performing the predictive modeling.

13. The system of claim 1 or 3, wherein the drug comprises at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

14. A method for administering a drug, comprising: sensing, with each sensor of a plurality of drug administration devices, information related to at least one of the drug administration device and the drug; wirelessly transmitting data indicative of the sensed information to a server using a communication interface of each of the plurality of drug administration devices; as well as The server includes a processor configured to perform predictive modeling of a clinical outcome for the patient, wherein the processor is further configured to determine that a treatment plan for the patient should be modified based on data received from at least one of the other patients.

15. The method of claim 14, wherein the drug comprises at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

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