Remote aggregation of drug delivery device data

Abstract

Generally, methods, systems, and devices are provided for remote aggregation of medication administration device data. In one exemplary embodiment, data indicative of information sensed by sensors in the medication administration device may be wirelessly transmitted from the medication administration device to a server. The server can use this data to correlate a patient's medication usage with the patient's clinical outcomes, perform a cost analysis of the patient's treatment, determine whether medications were delivered to the patient in compliance with the patient's treatment plan, identify malfunctions in the administration of medications, determine that additional data is needed from the medication administration device and trigger a request for the additional data to be transmitted wirelessly 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 devices for administering and / or delivering a drug. The present disclosure further relates to systems in which the devices may be used, and methods of administration, as well as further methods associated with the systems. [Background technology]

[0002] Pharmaceutical products (including large molecule and small molecule pharmaceuticals, hereafter "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 to the patient. For example, care must be taken to not administer more than a safe amount of drug to the patient. This requires consideration of the amount of the dose given and the time frame in which the dose is delivered, sometimes in relation to previous doses or doses of other drugs. Furthermore, care must be taken to not inadvertently administer the wrong drug to the patient, or a drug that has deteriorated due to its age or storage conditions. All of these considerations may be communicated in guidance associated with a particular drug or drug combination. However, this guidance is not always followed correctly, for example, due to mistakes such as human error. This can lead to adverse effects to the patient or result in inappropriate drug administration, for example, an insufficient or excessive volume of drug administered for a particular medical indication.

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

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

[0005] It may be desirable to monitor compliance with guidelines associated with drugs administered to patients in various dosage forms. This may provide assurance that correct procedures are being followed and may avoid the adoption of incorrect and potentially dangerous approaches. Furthermore, this may allow for optimization of the administration of drugs to patients.

[0006] However, it may be difficult to determine whether a drug is properly administered to a patient via a drug administration device and to monitor compliance. The onus of detecting and reporting proper drug administration typically lies on the patient, which may burden the patient with administrative tasks and / or may not be properly or timely reported to a medical professional who can address improper drug administration in a timely manner. Similarly, the onus of tracking and reporting compliance with guidelines provided to the patient by a physician or medical provider typically lies on the patient. The patient may feel uncomfortable reporting behavior that does not comply with the guidelines, and thus inaccurate data may be reported to and considered by a medical professional, which may negatively impact the patient's overall treatment. Summary of the Invention [Means for solving the problem]

[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 about 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 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 drug usage with the patient's clinical outcome; performing a cost analysis including comparing the patient's clinical outcome with clinical outcomes of other patients who received a drug different from the drug delivered to the patient; comparing side effects experienced by the patient with side effects experienced by other patients who received a drug different from 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 malfunction 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 transmitted wirelessly from the communications interface of the server to the communications interface of the drug administration device; and creating a predictive model of the patient's clinical outcome.

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

[0009] In another example, the processor may be configured to use the data in at least correlating the patient's drug use with the patient's clinical outcomes, and the processor may be configured to compare the correlation between the patient's drug use and the patient's clinical outcomes in at least one of: identifying trends in patient outcomes among a plurality of patients, including the patient who received the drug; and monitoring side effects of the drug for a plurality of patients, including the patient who received the drug.

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

[0011] In yet another example, the processor may be configured to use the data at least in determining whether 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 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 including the patient and a plurality of additional patients, where each patient in the specific population group shares common attributes including at least one of age, ethnicity, and genetic profile; and determining a trend in treatment plan compliance in a geographically specific population group including the patient and a plurality of additional patients.

[0012] In another example, the processor may be configured to use the data at least in identifying a malfunction in the administration of the medication, which may include an inability of the medication administration device to administer the medication to the patient, and the processor may also be configured to trigger an action for the patient to receive a new medication administration device.

[0013] In yet another example, the processor may be configured to use the data at least in identifying a malfunction in administration of the drug, which may include a user error in drug delivery, and the processor may also be configured to trigger an alert indicating the identified malfunction.

[0014] In yet another example, the processor may be configured to use the data at least in identifying malfunctions in the administration of the drug, which may include irregularities in the administration of a dose that is at least partially delivered to the patient, and the processor may also be configured to correlate the irregularities with a clinical outcome of the patient to determine whether the clinical outcome of the patient is better than the clinical outcomes of other patients who received the drug.

[0015] In another example, the processor may be configured to use the data in determining that additional data is required 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, where the additional data may include at least one of: a model number of the drug administration device when the drug was administered, a lot number of the drug administration device, a size of the dose size, a type of drug, and a viscosity of the drug.

[0016] In yet another example, the processor may be configured to use the data at least in creating a predictive model of a clinical outcome for the patient, and the processor may also be configured to use physician-inputted data regarding the patient in performing the predictive modeling.

[0017] In another example, the system may further include a plurality of additional drug administration devices, each configured to deliver at least one dose of a drug to a different patient, and each of the additional drug administration devices may include a sensor configured to sense information related to at least one of the drug administration device and the drug, and each of the additional drug administration devices may include a communications interface configured to wirelessly transmit data indicative of the sensed information to the server.

[0018] In yet another example, the drug can 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 that includes a server including a communication interface that wirelessly receives data transmitted by the communication interface of each of a plurality of drug administration devices, each of the plurality of drug administration devices configured to administer the same drug to a different patient of a plurality of patients. The server includes a processor configured to use the data in at least one of: correlating the patient's drug usage with the patient's clinical outcome, performing a cost analysis including comparing the patient's clinical outcome 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 the patient, determining whether the drug was delivered to the patient in compliance with the patient's individualized treatment plan, identifying a malfunction in any of the administration of the drugs, determining that additional data is needed from any of the drug administration devices to trigger a request for the additional data to be transmitted wirelessly from the communication interface of the server, and creating a predictive model of the patient's clinical outcome.

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

[0021] In another example, the processor may be configured to use the data at least in correlating patient drug use with patient clinical outcomes, and the processor may also be configured to at least one of identify trends in patient outcomes among a plurality of patients and monitor side effects of the drug for a plurality of patients.

[0022] In yet another example, the processor may be configured to use the data at least in performing a cost analysis, and the processor may also be configured to identify a second drug that has a lower cost than the drug and is associated with substantially the same clinical outcome as the patient's clinical outcome.

[0023] In yet another example, the processor may be configured to use the data in determining at least whether medication was delivered to the patient in compliance with the patient's individualized treatment plan, and the processor may also be configured to use the determination in at least one of generating an alert to a physician indicating at least one of the patient's compliance and determining a trend in the patient's compliance.

[0024] In another example, the processor may be configured to use the data at least in identifying a malfunction in the administration of the medication, which may include an inability of the medication administration device to administer the medication to the patient, and the processor may also be configured to trigger an action for the patient to receive a new medication administration device.

[0025] In yet another example, the processor may be configured to use the data in identifying at least any malfunction in the administration of the drug, which may include a user error in drug delivery, and the processor may also be configured to trigger an alert indicating the identified malfunction.

[0026] In yet another example, the processor may be configured to use the data in identifying at least a malfunction in any of the administrations of the drug, which may include an irregularity in any of the at least partially delivered administrations, and the processor may also be configured to correlate the irregularity with a clinical outcome of the patient to determine whether the clinical outcome of the patient is better than the clinical outcome of other patients who received the drug.

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

[0028] In yet another example, the processor may be configured to use the data at least in creating a predictive model of a clinical outcome for the patient, and the processor may also be configured to use physician-inputted data regarding the patient in performing the predictive modeling.

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

[0030] In another aspect, a drug administration method is provided herein. In one embodiment, the method includes sensing information related to at least one of the drug administration device and the drug with a sensor of the drug administration device. The method further includes wirelessly transmitting data indicative of 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 in at least one of: correlating the patient's drug usage with the patient's clinical outcome; performing a cost analysis including comparing the patient's clinical outcome with clinical outcomes of other patients who received a drug different from the drug delivered to the patient; comparing side effects experienced by the patient with side effects experienced by other patients who received a drug different from 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 malfunction 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 creating a predictive model of the patient's clinical outcome.

[0031] The method may have various variations. For example, the drug may include at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate. [Brief description of the drawings]

[0032] The present invention will now be described with reference to the accompanying drawings in which: [Figure 1] FIG. 1 is a schematic diagram of a first type of drug administration device, namely an autoinjector. [Diagram 2] FIG. 2 is a schematic diagram of a second type of drug administration device, namely an infusion pump. [Diagram 3] FIG. 2 is a schematic diagram of a third type of drug administration device, namely an inhaler. [Figure 4]FIG. 1 is a schematic diagram of a fourth type of drug delivery device, namely a nasal spray device. [Figure 5A] FIG. 1 is a schematic diagram of a typical drug administration device. [Figure 5B] FIG. 1 is a schematic diagram of a universal drug administration device. [Figure 6] FIG. 1 is a schematic diagram of a housing of the dosage form. [Figure 7] 1 is a schematic diagram of one embodiment of a communication network system in which the medication administration device and housing can operate. [Figure 8] 1 is a schematic diagram of one embodiment of a computer system in which the drug administration device and housing may operate. [Figure 9] 1 is a flow chart illustrating an embodiment of a method for updating a patient monitoring form and identifying one or more abnormal sensed parameters. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the 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 detailed herein and shown in the accompanying drawings are non-limiting exemplary embodiments, and the scope of the invention is defined solely by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be within the scope of the invention.

[0034] Furthermore, in this disclosure, like-named components of the embodiments generally have similar characteristics, and therefore, in a particular embodiment, each feature of each like-named component is not necessarily described in full detail. Additionally, to the extent that linear or circular dimensions are used in describing the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that may be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that the equivalent of such linear and circular dimensions for any geometric shape can be readily determined. Those skilled in the art will understand that, although the dimensions are not exact values, they are believed to be close to the values ​​due to factors such as manufacturing tolerances and sensitivity of measuring equipment. The size and shape of the systems and devices, and their components, may depend on at least the size and shape of the components with which the systems and devices are used.

[0035] 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 referenced figures.

[0036] Autoinjector FIG. 1 is a schematic, exemplary diagram of a first type of drug delivery device, i.e. an injection device, in this example an autoinjector 100, usable in the embodiments described herein. The autoinjector 100 comprises a drug holder 110 for holding a 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 is typically in the form of a container for containing the drug, for example the drug holder 110 may be provided in the form of a syringe or a vial, or any other suitable container capable of holding a drug. The autoinjector 100 comprises an ejection nozzle 122, e.g. a needle of a syringe, provided at the distal end of the drug holder 110. The dispensing mechanism 120 comprises a drive element 124, which itself may also comprise a piston and / or a piston rod, as well as a drive mechanism 126. The dispensing mechanism 120 is located proximal to the end of the medication holder 110 and toward the proximal end of the autoinjector 100 .

[0037] The autoinjector 100 comprises a housing 130 that houses within its body the drug holder 110, the drive element 124, and the drive mechanism 126, as well as an ejection nozzle 122 that is typically fully contained within the housing prior to injection, but which extends from the housing 130 to deliver the drug during an injection sequence. The dispensing mechanism 120 is positioned such that the drive element 124 is advanced through the drug holder 110 to dispense the drug through the ejection nozzle 122, thereby enabling the autoinjector to administer the drug held within the drug holder 110 to a patient. In some cases, a user may manually advance the drive element 124 through the drug holder 110. In other cases, the drive mechanism 126 may include a stored energy source 127 that advances the drive element 124 without user assistance. The stored energy source 127 may include a resilient biasing member, such as a spring, or pressurized gas, or an electronically powered motor and / or gearbox.

[0038] The autoinjector 100 includes a dispensing mechanism protection mechanism 140. The dispensing mechanism protection mechanism 140 typically has two functions. First, the dispensing mechanism protection mechanism 140 may function to prevent access to the discharge nozzle 122 before and after an injection. Second, the autoinjector 100 may function to allow the dispensing mechanism 120 to be actuated when the dispensing mechanism protection mechanism 140 is armed, e.g., moved to an unlocked position.

[0039] The protection mechanism 140 covers at least a portion of the discharge nozzle 122 when the medication holder 110 is in a retracted position proximally within the housing 130. This is to prevent contact between the discharge nozzle 122 and a user. Alternatively or additionally, the protection mechanism 140 is configured to retract itself proximally to expose the discharge nozzle 122, so that the discharge nozzle 122 can be contacted by a patient. The protection mechanism 140 comprises a shield member 141 and a return spring 142. The return spring 142 acts to extend the shield member 141 from the housing 130, thereby covering the discharge nozzle 122, when no force is applied to the distal end of the protection mechanism 140. When a user applies 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 within the housing 130, thereby exposing the discharge nozzle 122. The protection mechanism 140 may alternatively or additionally comprise an extension mechanism (not shown) for extending the discharge nozzle 122 beyond the housing 130, and may further comprise a retraction mechanism (not shown) for retracting the discharge nozzle 122 into the housing 130. The protection mechanism 140 may alternatively or additionally comprise a housing cap and / or a discharge nozzle boot that may be attached to the autoinjector 100. Removal of the housing cap typically also removes the discharge nozzle boot from the discharge nozzle 122.

[0040] The autoinjector 100 also includes a trigger 150. The trigger 150 comprises a trigger button 151 located on an exterior surface of the housing 130 so as to be accessible by a user of the autoinjector 100. When the trigger 150 is pressed by the user, the trigger 150 releases the drive mechanism 126, which acts via the drive element 124 and then the medicament to be forced out of the medicament holder 110 via the discharge nozzle 122.

[0041] Trigger 150 may also cooperate with shield member 141 in a manner that prevents trigger 150 from being actuated until shield member 141 is retracted proximally sufficiently into an unlocked position within housing 130, for example, by pressing a distal end of shield member 141 against the patient's skin. Once this is done, trigger 150 is unlocked and autoinjector 100 is actuated such that trigger 150 may be pressed and an injection and / or drug delivery sequence may then be initiated. Alternatively, retracting shield member 141 proximally into housing 130 alone may act to actuate drive mechanism 126 and initiate an injection and / or drug delivery sequence. In this manner, autoinjector 100 has a device actuation prevention mechanism that prevents dispensing of drug, for example, by preventing accidental release of dispensing mechanism 120 and / or accidental actuation of trigger 150.

[0042] Although the above description relates to one example of an autoinjector, this example is presented purely for illustrative purposes and the invention is not limited to only such autoinjectors. Those skilled in the art will appreciate that various modifications to the autoinjector described may be implemented within the scope of the present disclosure.

[0043] The autoinjector of the present disclosure may be used to administer any of a variety of drugs, such as any of epinephrine, Rebif, Enbrel, Aranesp, atropine, pralidoxime chloride, and diazepam.

[0044] Infusion pump In other situations, patients may require precise continuous delivery of medication, or regular or frequent delivery of medication at set periodic intervals. Infusion pumps can provide such controlled drug infusion by facilitating administration of medication at precise rates that keep drug concentrations within therapeutic limits without the need for frequent attention by a medical professional or the patient.

[0045] 2 is a schematic, exemplary diagram of a second type of drug delivery device, an infusion pump 200, usable in the embodiments described herein. The infusion pump 200 comprises a drug holder 210 in the form of a reservoir for containing the drug to be delivered, and a dispensing mechanism 220 comprising 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 in a housing 230. The dispensing mechanism 220 further comprises an infusion line 212. The drug is delivered from the reservoir via the infusion line 212, which may take the form of a cannula, upon actuation of the pump 216. The pump 216 may take 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, arterial, and epidural injections may also be used.

[0046] The infusion pumps of the present disclosure may be used to administer any of a variety of drugs, such as any of insulin, atropine sulfate, avibactam sodium, bendamustine hydrochloride, carboplatin, daptomycin, epinephrine, levetiracetam, oxaliplatin, paclitaxel, pantoprazole sodium, treprostinil, vasopressin, voriconazole, and zoledronic acid.

[0047] Infusion pump 200 further includes a processor 296, as well as control circuitry, e.g., a memory 297, and a user interface 280, which together provide a trigger mechanism and / or a dose selector for pump 200. User interface 280 may be implemented by a display screen located on housing 230 of infusion pump 200. The control circuitry and user interface 280 may be located within or external to housing 230 and communicate with pump 216 via a wired or wireless interface to control its operation.

[0048] The operation of the pump 216 is controlled by a processor 296, which communicates with the pump 216 to control the operation of the pump. The processor 296 may be programmed by a user (e.g., a patient or a medical professional) via a user interface 280. This allows the infusion pump 200 to deliver medication to the patient in a controlled manner. The user may input parameters such as the infusion duration and delivery rate. The delivery rate may be set by the user to a constant infusion rate or as set intervals, typically within preprogrammed limits, for periodic delivery. The programmed parameters for controlling the pump 216 are stored in and retrieved from a memory 297, which communicates with the processor 296. The user interface 280 may take the form of a touch screen or a keypad.

[0049] Power supply 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.

[0050] Infusion pump 200 can take a variety of different physical forms depending on its intended use. Infusion pump 200 can be a fixed, non-portable device, for example, for use at a patient's bedside, or it can be an ambulatory infusion pump designed to be portable or wearable. An integrated power supply 295 is particularly beneficial for ambulatory infusion pumps.

[0051] Although the foregoing description relates to one example of an infusion pump, this example is provided purely for illustrative purposes. The present disclosure is not limited to such infusion pumps. Those skilled in the art will appreciate that various modifications to the described infusion pumps 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.

[0052] inhaler Fig. 3 is a schematic diagram of a third type of drug administration device, namely an inhaler 300. The inhaler 300 comprises a drug holder 310 in the form of a canister. The drug holder 310 typically contains a drug in solution or suspension with a suitable carrier liquid. The inhaler 300 further comprises a dispensing mechanism 320, which comprises a pressurized gas for pressurizing the drug holder 310, a valve 325 and a nozzle 321. The valve 325 forms the outlet of the drug holder 310. The valve 325 comprises a narrow opening 324 formed in the drug holder 310 and a movable element 326 that controls the opening 324. When the movable element 326 is in the rest position, the valve 325 is in a closed or non-actuated state in which the opening 324 is closed and the drug holder 310 is sealed. When the movable element 326 is actuated from the rest position to the actuated position, the valve 325 is actuated to an open state in which the opening 324 is open. Actuation of the movable element 326 from the rest position to the actuated position involves moving the movable element 326 into the drug holder 310. The movable element 326 is elastically biased to the rest position. In the open state of the valve 325, the pressurized gas pushes the drug, which is in a solution or suspension with a suitable liquid, out of the drug holder 310 at high speed through the opening 324. The high speed passage of the liquid through the narrow opening 324 causes the liquid to be atomized, i.e., converted from a bulk liquid into a mist of fine droplets of liquid and / or a gas cloud. The patient may inhale the mist of fine droplets and / or the gas cloud into the respiratory pathway. Thus, the inhaler 300 can deliver the drug held in the drug holder 310 into the patient's respiratory pathway.

[0053] The drug holder 310 is removably held within the housing 330 of the inhaler 300. A passageway 333 formed within the housing 330 connects a first opening 331 within the housing 330 and a second opening 332 within the housing 330. The drug holder 310 is received within the passageway 333. The drug holder 310 is slidably insertable within the passageway 333 through the first opening 331 of the housing 330. The second opening 332 of the housing 330 forms a mouthpiece 322 configured to be placed within the patient's mouth, or a nosepiece configured to be placed within the patient's nostrils, or a mask configured to be placed over the patient's mouth and nose. The drug holder 310, the first opening 331, and the passageway 333 are sized such that air can flow through the passageway 333 around the drug holder 310 between the first opening 331 and the second opening 332. The inhaler 300 may include a dispensing mechanism protection mechanism 140 in the form of a cap (not shown) that may be fitted onto the mouthpiece 322 .

[0054] The inhaler 300 further comprises a trigger 350 including a valve actuation feature 355 configured to actuate the valve 325 when the trigger 350 is actuated. The valve actuation feature 355 is a protrusion of the housing 330 into the passageway 333. The medication holder 310 is slidably movable within the passageway 333 from a first position to a second position. In the first position, an end of the movable element 326 in a rest position abuts the valve actuation feature 355. In the second position, the medication holder 310 can be displaced towards the valve actuation feature 355 such that the valve actuation feature 355 moves the movable element 326 into the medication holder 310 to actuate the valve 325 to an open state. The user's hand provides the force required to move the medication holder 310 against the resiliently biased movable element 326 from the first position to the second position. Valve actuation feature 355 includes an inlet 356 connected to nozzle 321. Inlet 356 of valve actuation feature 355 is sized and positioned to mate with opening 324 of valve 325 such that an ejected mist of droplets and / or gas cloud can enter inlet 356 and exit nozzle 321 into passageway 333. Nozzle 321 aids in the atomization of the bulk liquid into a mist of droplets and / or gas cloud.

[0055] The valve 325 provides a metering mechanism 370 that is configured to close the valve after a measured amount of liquid, and therefore the 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 pre-set, but the inhaler 300 may include a dose selector 360 that is user-operable to vary the defined amount of liquid.

[0056] Although the above description relates to one particular example of an inhaler, this example is purely illustrative. The description should not be considered as being limited to only such an inhaler. Those skilled in the art will appreciate that numerous other types of inhalers and nebulizers can be used with the present disclosure. For example, the drug can be in powder form, the drug can be in liquid form, or the drug can be atomized by other forms of dispensing mechanism 320, including ultrasonic vibrations, compressed gas, vibrating mesh, or heat source.

[0057] The inhaler of the present disclosure may 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.

[0058] Drug Delivery Devices As will be appreciated from the foregoing, various components of a drug delivery device are common to all such devices. These components form the essential components of a universal drug administration device. The drug administration device delivers a drug to a patient, the drug being provided within the drug administration device in a defined dosage form.

[0059] Nasal spray device FIG. 4 is a schematic diagram of a fourth type of drug delivery device, namely, a nasal spray device 400. The nasal spray device 400 is configured to release a drug into the patient's nose. The nasal spray device 400 includes a drug holder 402 configured to contain a drug therein for delivery from the device 400 to the patient. The drug holder 102 may have a variety of configurations, such as a bottle reservoir, a cartridge, a vial (as in this exemplary embodiment), a Blow-Fill-Seal (BFS) capsule, a blister pack, and the like. In one exemplary embodiment, the drug holder 402 is a vial. An exemplary vial is formed of one or more materials, such as glass, polymers, and the like. In some embodiments, the vial may be formed of glass. In other embodiments, the vial may be formed of one or more polymers. In still other embodiments, different portions of the vial may be formed of different materials. The exemplary vial may have a variety of features that facilitate sealing and storing a drug therein, as described herein and shown in the figures. However, one of ordinary skill in the art will recognize that the 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 only to represent certain exemplary embodiments.

[0060] The opening 404 of the nasal spray device 400, through which the medication exits the nasal spray device 400, is formed in a dispensing head 406 of the nasal spray device 400 and in a tip 408 of the dispensing head 406. The tip 408 is configured to be inserted into a patient's nostril. In one exemplary embodiment, the tip 408 is configured to be inserted into a first nostril of the patient during a first phase of operation of the nasal spray device 400 and into a second nostril of the patient during a second phase of operation of the nasal spray device 400. The first and second phases of operation involve two separate actuations of the nasal spray device 400, a first actuation corresponding to a first dose of medication being delivered and a second actuation corresponding to a second dose of medication being delivered. In some embodiments, the nasal spray device 400 is configured to be actuated only once to deliver one nasal spray. In some embodiments, the nasal spray device 400 is configured to be actuated three or more times to deliver three or more nasal sprays, for example, four, five, six, seven, eight, nine, ten, etc.

[0061] The dispensing head 406 includes a depth guide 410 configured to contact the patient's skin between the patient's first and second nostrils such that the longitudinal axis of the dispensing head 406 is substantially aligned with the longitudinal axis of the nostril into which the tip 408 is inserted. Those skilled in the art will appreciate that due to any number of factors, such as manufacturing tolerances and sensitivity of measurement equipment, the longitudinal axes may not be precisely aligned, but may be considered substantially aligned.

[0062] In an exemplary embodiment, as in FIG. 4, the dispensing head 406 has a tapered shape, with the dispensing head 406 having a smaller diameter at its distal end than at its proximal end where the opening 404 is located. The opening 404 having a relatively smaller diameter facilitates spraying of the medicament from the opening 404, as will be understood by one of ordinary skill in the art. Located within the proximal portion of the tapered dispensing head 406 distal to the opening 404 is a spray chamber 412 through which the medicament is configured to pass before exiting the opening 404. As the medicament passes rapidly through the spray chamber 412, the spray chamber 412 facilitates the generation of a fine mist that exits through the opening 404 with a consistent spray turn. Arrows 414 in FIG. 4 indicate the path of travel of the medicament from the medicament holder 402 and out of the opening 404.

[0063] 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 drug simultaneously into two nostrils in response to a single actuation.

[0064] The dispensing head 406 is configured to be pressed towards the medication holder 402, for example by a user depressing the depth guide 410, to actuate the nasal spray device 400. In other words, the dispensing head 406 is configured as an actuator that is actuated to expel the medication from the medication holder 402 and out of the nasal spray device 400. In one 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 who receives the medication from the nasal spray device 400, although another person may actuate the nasal spray device 400 for delivery to another person.

[0065] Actuation, e.g., pressing, of the dispensing head 406 is configured to force vent air into the drug holder 402, as shown by arrow 416 in FIG. 4. The air entering the drug holder 402 moves the drug within the drug holder through tube 418 and then into metering chamber 420, which moves the drug proximally through cannula 422, through spray chamber 412, and then out opening 404. In response to release of the dispensing head 406, e.g., when a user stops pressing downwardly on the dispensing head 406, a biasing spring 426 returns the dispensing head 406 to its default rest position to position the dispensing head 406 relative to the drug holder 402 for subsequent actuation and drug delivery.

[0066] Although the above description relates to one particular example of a nasal spray device, this example is purely illustrative. This description should not be considered as being limited to only such a nasal spray device. Those skilled in the art will appreciate that the nasal spray device 400 may include different features in different embodiments according to various requirements. For example, the nasal spray device 400 may lack a depth guide 410 and / or may include any one or more of a device indicator, a sensor, a communication interface, a processor, a memory, and a power source.

[0067] The nasal spray device of the present disclosure may be used to administer any of a variety of drugs, such as ketamine (e.g., Ketalar®), esketamine (e.g., Spravato®, Ketanest®, and Ketanest-S®), naloxone (e.g., Narcan®), and sumatriptan (e.g., Imitrex®).

[0068] 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 universal drug administration devices 500 include injection devices (e.g., autoinjectors, jet injectors, and infusion pumps), nasal spray devices, and inhalers.

[0069] As shown in Figure 5A, the drug administration device 501 in its general form includes features of a drug holder 10 and a dispensing mechanism 20. The drug holder 10 holds a 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 may be administered to a patient.

[0070] 5B shows a further universal drug administration device 500 including several additional features. Those skilled in the art will appreciate that these additional features are optional for different embodiments and may be utilized in a variety of different combinations such that additional features may be present 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 being treated with the drug, safety requirements, whether the device is powered, whether the device is portable, whether the device is used for self-administration, and many other requirements that will be appreciated by those skilled in the art. Similar to the universal device of FIG. 5A, the drug administration device 500 comprises a housing 30 that houses the drug holder 10 and the dispensing mechanism 20.

[0071] The device 500 comprises a trigger mechanism 50 for initiating the release of the drug from the drug holder 10 by the dispensing mechanism 20. The device 500 includes a metering / dispensing mechanism 70 feature that measures a set dose released from the drug holder 10 via the dispensing mechanism 20. In this manner, the drug dispensing device 500 may provide a known dose of a determined size. The device 500 comprises a dose selector 60 that allows a user to set a dose volume of the drug to be measured by the metering mechanism 70. The dose volume may be set to one particular value of a plurality of predetermined individual dose volumes or any value of a predetermined dose volume within a range of dose volumes.

[0072] The device 500 may comprise a device operation prevention mechanism 40 or 25, which 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 may prevent accidental dispensing of the drug, e.g., to prevent dosing at the wrong time or to prevent inadvertent actuation. The device 500 also includes a dispensing mechanism protection mechanism 42, which prevents access to at least a portion of the dispensing mechanism 20, e.g., for safety reasons. The device operation prevention mechanism 40 and the dispensing mechanism protection mechanism 42 may be the same component.

[0073] 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 that may be configured to present information regarding the device 500 to a user of the device 500 and / or to allow 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 dosage form and device parameters. As an 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 a dose selected by a user using the dose selector 60, a dose metered by the metering mechanism 70, and a dose dispensed by the dispensing mechanism 20. Similarly, an environmental sensor 94 is provided that is configured to sense information regarding the environment in which the device 500 resides, such as the temperature of the environment, the temperature of the environment, location, and time. There may be a dedicated location sensor 98 configured to determine the geographic location of the device 500, for example via satellite positioning such as GPS. The device 500 also includes a communication interface 99 that may communicate data obtained from the various sensors regarding the device and / or medication to the outside world.

[0074] Optionally, the device 500 includes a power source 95 for delivering 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 including a processor 96 and memory 97 that 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 obtained from the environmental sensor 94, the device sensor 92, the communication interface 99, the position sensor 98, and / or the user interface 80, process it, and provide a data output, for example, to the indicator 85 and / or to the communication interface 99.

[0075] In some embodiments, the drug administration device 500 is sealed within packaging 35. The packaging 35 may further include a combination of a processor 96, memory 97, user interface 80, device indicators 85, device sensors 92, position sensors 98, and / or environmental sensors 94, as described herein, which may be located external to the housing of the device 500.

[0076] Those skilled in the art will appreciate that the universal drug administration device 500, comprising a drug holder 10 and a dispensing mechanism 20, may comprise the various optional features described above in a number of different combinations. Additionally, the drug administration device 500 may optionally include more than one drug holder 10 with more than one dispensing mechanism 20, such that each drug holder has its own associated dispensing mechanism 20.

[0077] Drug Form Traditionally, drug delivery devices utilize liquid dosage forms, however, it will be appreciated that other dosage forms may be utilized.

[0078] One such common dosage form is a tablet. Tablets can be formed from a combination of a drug and excipients that are compressed together. Other dosage forms are pastes, creams, powders, ear drops, and eye drops.

[0079] Further examples of drug dosage forms include skin patches, drug-eluting stents, and intrauterine devices. In these examples, the body of the device may be configured to include the drug and allow for the release of the drug under certain circumstances. For example, a skin patch may include a polymer composition containing the drug. The polymer composition allows the drug to diffuse from the polymer composition into the patient's skin. Drug-eluting stents and intrauterine devices may operate in a similar manner. In this way, patches, stents, and intrauterine devices may themselves be considered drug holders with associated dispensing mechanisms.

[0080] Any of these dosage forms may be configured to trigger drug release upon a specific condition. This may allow the drug to be released at a desired time or location after the dosage form is introduced into the patient. In particular, drug release may be triggered by an external stimulus. Additionally, these dosage forms may be contained within a housing, which may be a form of packaging, prior to administration. This housing may include some of the optional features described above that are utilized in the universal drug administration device 500.

[0081] A drug administered by the drug delivery device of the present disclosure can be any substance that, when consumed, causes a change in the physiology or psychology of an organism. Examples of drugs that may be administered by the drug delivery device of the present disclosure include 5-alpha-reductase inhibitors, 5-aminosalicylate, 5HT3 receptor antagonists, ACE inhibitors with calcium channel blockers, ACE inhibitors with thiazides, adamantane antivirals, adrenal corticosteroids, adrenal corticosteroid inhibitors, adrenergic bronchodilators, hypertension emergency medications, pulmonary hypertension medications, aldosterone receptor antagonists, alkylating agents, allergens, α-glucosidase inhibitors, replacement drugs, amebicide, amino Glycosides, Aminopenicillins, Aminosalicylates, AMPA receptor antagonists, Amylin analogues, Analgesic combinations, Analgesics, Androgenic and anabolic steroids, Angiotensin converting enzyme inhibitors, Angiotensin II inhibitors with calcium channel blockers, Angiotensin II inhibitors with thiazides, Angiotensin receptor blockers, Angiotensin receptor blockers and neprilysin inhibitors, Anorectal preparations, Appetite suppressants, Antacids, Anthelmintics, Antiangiogenic ophthalmic agents, Anti-CTLA-4 monoclonal antibodies, Anti-infectives, Anti PD-1 monoclonal antibodies, antiadrenergics (central) including thiazides, antiadrenergics (peripheral) including thiazides, antiadrenergics, centrally acting, antiadrenergics, peripherally acting, antiandrogens, antianginals, antiarrhythmics, antiasthmatic combinations, antibiotics / antineoplastics, anticholinergic antiemetics, anticholinergic antiparkinsonians, anticholinergic bronchodilators, anticholinergic chronotropic agents, anticholinergic / antispasmodics, anticoagulant reversals, anticoagulants, anticonvulsants, antidepressants, antidiabetics , antidiabetic combinations, antidiarrheals, antidiuretic hormones, antidotes, antiemetics / antivertigo drugs, antifungals, antigonadotropics, antigout drugs, antihistamines, antilipidemic drugs, antilipidemic combinations, antihypertensive combinations, antihyperuricemia drugs, antimalarials, antimalarial combinations, antimalarial quinolones, antimanic drugs, antimetabolites, antimigraine drugs, antineoplastic combinations, antineoplastic antidotes, antineoplastic interferons, antineoplastic drugs, antiparkinson drugs, antiplatelet drugs, antipseudomonal penicillins, psoriasis drugs, antipsychotics, antirheumatic drugs,Antiseptics and disinfectants, Antithyroid agents, Antitoxins and antivenins, Antituberculous agents, Antituberculous combinations, Antitussives, Antivirals, Antiviral boosters, Antiviral combinations, Antiviral interferons, Anxiolytics, Sedatives, and Hypnotics, Aromatase inhibitors, Atypical antipsychotics, Azole antifungals, Bacterial vaccines, Barbiturate anticonvulsants, Barbiturates, BCR-ABL tyrosine kinase inhibitors, Benzodiazepine anticonvulsants, Benzodiazepines, Beta blockers including calcium channel blockers, Beta blockers including thiazides, Beta adrenergic Phosphate blockers, beta-lactamase inhibitors, bile acid sequestrants, biologics, bisphosphonates, bone morphogenetic proteins, bone resorption inhibitors, bronchodilator combinations, bronchodilators, calcium receptor agonists, calcineurin inhibitors, calcitonin, calcium channel blockers, carbamate anticonvulsants, carbapenems, carbapenem / beta-lactamase inhibitors, carbonic anhydrase inhibitors, carbonic anhydrase inhibitors, cardiac stress agents, cardiac selective beta-blockers, cardiovascular agents, catecholamines, cation exchange resins, CD20 monoclonal antibodies, CD30 monoclonal antibodies Monoclonal antibodies, CD33 monoclonal antibodies, CD38 monoclonal antibodies, CD52 monoclonal antibodies, CDK4 / 6 inhibitors, central nervous system drugs, cephalosporins, cephalosporin / beta-lactamase inhibitors, cerumenolytics, CFTR combinations, CFTR potentiators, CGRP inhibitors, chelators, chemokine receptor antagonists, chloride channel activators, cholesterol absorption inhibitors, cholinergic agonists, cholinergic muscle stimulants, cholinesterase inhibitors, CNS stimulants, coagulation modifiers, colony stimulating factors, contraceptives, adrenocortical stimulants Hormones, coumarins and indanediones, cox-2 inhibitors, decongestants, dermatological drugs, diagnostic radiopharmaceuticals, diarylquinolines, dibenzazepine anticonvulsants, digestive enzymes, dipeptidyl peptidase 4 inhibitors, diuretics, dopaminergic antiparkinsonian drugs, drugs used in alcoholism, echinocandins, EGFR inhibitors, estrogen receptor antagonists, estrogens, expectorants, factor Xa inhibitors, fatty acid derivative anticonvulsants, fibric acid derivatives, 1st generation cephalosporins, 4th generation cephalosporins, functional bowel disorder drugs, gallstone solubilizers,gamma-aminobutyric acid analogues, gamma-aminobutyric acid reuptake inhibitors, gastrointestinal agents, general anesthetics, genitourinary tract agents, gastrointestinal stimulants, glucocorticoids, glucose-elevating agents, glycopeptide antibiotics, glycoprotein platelet inhibitors, glycylcyclines, gonadotropin-releasing hormone, gonadotropin-releasing hormone antagonists, gonadotropins, group I antiarrhythmics, group II antiarrhythmics, group III antiarrhythmics, group IV antiarrhythmics, group V antiarrhythmics, growth hormone receptor blockers, growth hormone, guanylate cyclase-C agonists, Helicobacter pylori eradication agents, H2 antagonists Anti-cancer drugs, Hedgehog pathway inhibitors, Hematopoietic stem cell mobilizers, Heparin antagonists, Heparin, HER2 inhibitors, Herbal products, Histone deacetylase inhibitors, Hormones, Hormonal / Antineoplastic drugs, Hydantoin anticonvulsants, Hydrazide derivatives, Illegal (street) drugs, Immunoglobulins, Immunologic agents, Immunostimulants, Immunosuppressants, Impotence drugs, In vivo diagnostic biologics, Incretin mimetics, Inhaled anti-infectives, Inhaled corticosteroids, Inotropic agents, Insulin, Insulin-like growth factors, Integrase strand transfer inhibitors, Interferons, Interleukin inhibitors , interleukins, parenteral nutrition products, iodized contrast media, ionic iodized contrast media, iron products, ketolides, laxatives, antileprosy drugs, leukotriene modifiers, lincomycin derivatives, local injectable anesthetics, local injectable anesthetics including corticosteroids, loop diuretics, pulmonary surfactants, lymphatic stains, lysosomal enzymes, macrolide derivatives, macrolides, magnetic resonance imaging contrast agents, mast cell stabilizers, medical gases, meglitinides, metabolic agents, methylxanthines, mineralocorticoids, minerals and electrolytes, other drugs, other analgesics, other antibiotics, and its Other Anticonvulsants, Other Antidepressants, Other Antidiabetics, Other Antiemetics, Other Antifungals, Other Antilipidemics, Other Antihypertensive Combinations, Other Antimalarials, Other Antineoplastics, Other Antiparkinsonian Drugs, Other Antipsychotics, Other Antituberculous Drugs, Other Antiviral Drugs, Other Anxiolytics, Sedatives and Hypnotics, Other Bone Resorption Inhibitors, Other Cardiovascular Drugs, Other Central Nervous System Drugs, Other Coagulation Modifiers, Other Diagnostic Dyes, Other Diuretics, Other Genitourinary Tract Drugs, Other Gastrointestinal Drugs, Other Hormones, Other Metabolic Agents,Other Ophthalmic Medications, Other Ophthalmic Medications, Other Respiratory Medications, Other Sex Hormones, Other Topical Medications, Other Unclassified Medications, Other Vaginal Medications, Mitosis Inhibitors, Monoamine Oxidase Inhibitors, Mouth and Throat Products, mTOR Inhibitors, Mucolytics, Multikinase Inhibitors, Muscle Relaxants, Mydriatics, Narcotic Analgesic Combinations, Narcotic Analgesics, Nasal Anti-Infectives, Nasal Antihistamines and Decongestants, Nasal Lubricants and Irrigators, Nasal Preparations, Nasal Steroids, Natural Penicillins, Neprilysin Inhibitors, Neuraminidase Inhibitors, Neuromuscular Blockers, Neuropotassium Channel Orthodontics Puna, Next Generation Cephalosporins, Nicotinic Acid Derivatives, NK1 Receptor Antagonists, NNRTIs, Non Cardioselective Beta Blockers, Non Iodized Contrast Media, Non Ionic Iodized Contrast Media, Non Sulfonylureas, Non Steroidal Anti Inflammatory Drugs, NS5A Inhibitors, Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Dietary Supplements, Dietary Products, Ophthalmic Anesthetics, Ophthalmic Anti Infectives, Ophthalmic Anti Inflammatory Drugs, Ophthalmic Antihistamines and Decongestants, Ophthalmic Diagnostics, Ophthalmic Glaucoma Drugs, Ophthalmic Lubricants and Cleansers, Ophthalmic Preparations, Ophthalmic Steroids, Ophthalmic Steroids Including Anti Infectives, Ophthalmic Surgical Drugs, Oral Nutritional Supplements agents, other immunostimulants, other immunosuppressants, otic anesthetics, otic anti-infectives, otic preparations, otic steroids, otic steroids including anti-infectives, oxazolidinone anticonvulsants, oxazolidinone 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 antiobesity agents, phenothiazine antiemetics, phenothiazine antipsychotics, phenylpiperazine antidepressants, phosphate binders, PI3K inhibitors, hemolytic agents, hemolytic agents, hemolytic agents Plasma expanders, platelet aggregation inhibitors, platelet stimulants, polyenes, potassium-sparing diuretics including thiazides, potassium-sparing diuretics, probiotics progesterone receptor modulators, progestins, prolactin inhibitors, prostaglandin D2 antagonists, protease inhibitors, protease-activated receptor 1 antagonists, proteasome inhibitors, proton pump inhibitors, psoralens, psychotherapeutic drugs, psychotherapeutic combinations, purine nucleosides, pyrrolidine anticonvulsants, quinolones, radiocontrast agents, radioadjuvants, radiotherapeutic drugs, radioconjugates, radiopharmaceuticals,recombinant human erythropoietin, renin inhibitors, respiratory agents, respiratory inhalation products, rifamycin derivatives, salicylates, sclerosing agents, second generation cephalosporins, selective estrogen receptor modulators, selective immunosuppressants, selective phosphodiesterase-4 inhibitors, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, serotonergic neuroenteric regulators, sex hormone combinations, sex hormones, SGLT-2 inhibitors, skeletal muscle relaxant combinations, bone Muscle relaxants, antismoking agents, somatostatin and somatostatin analogues, spermicides, statins, sterile irrigation solutions, streptogramins, streptomyces derivatives, succinimide anticonvulsants, sulfonamides, sulfonylureas, synthetic ovulation stimulants, tetracyclic antidepressants, tetracyclines, therapeutic radiopharmaceuticals, therapeutic vaccines, thiazide diuretics, thiazolidinediones, thioxanthenes, third generation cephalosporins, thrombin inhibitors, thrombolytic agents, thyroid agents, TNF alpha inhibitors anti-inflammatory agents, tocolytic agents, topical acne agents, topical agents, topical allergy diagnostic agents, local anesthetics, topical anti-infectives, topical anti-rosacea agents, topical antibiotics, topical anti-fungal agents, topical antihistamines, topical antineoplastic agents, topical anti-psoriatic agents, topical anti-viral agents, topical astringents, topical debridements, topical depigmenting agents, topical emollients, topical keratolytic agents, topical non-steroidal anti-inflammatory agents, topical photochemotherapeutic agents, topical rubefacients, topical steroids, topical steroids including anti-infectives, transthyretin analgesics The drug delivery device of the present disclosure includes epinephrine, Rebif, Enbrel, Aranesp, atropine, pralidoxime chloride, diazepam, insulin, amphoteric 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, glycopyrrolate, tiotropium, aclidinium, indacaterol, salmeterol, In one embodiment, a drug selected from the group consisting of cyclosporine, cyclosporine, and olodaterol may be administered.

[0082] As mentioned above, any of a variety of drugs can be delivered using the drug administration device. Examples of drugs that can be delivered using the drug administration device described herein include Remicade® (infliximab), Stelara® (ustekinumab), Simponi® (golimumab), Simponi Aria® (golimumab), Darzalex® (daratumumab), Tremfya® (guselkumab), Eprex® (epoetin alfa), Risperdal Constra® (risperidone), Invega Sustenna® (paliperidone palmitate), Spravato® (esketamine), ketamine, and Invega Trinza® (paliperidone palmitate).

[0083] Drug Housing As noted above, the dosage form may be provided in a holder appropriate for the particular dosage form utilized. For example, a drug in liquid dosage form may be held in a holder in the form of a vial having a stopper or a syringe having a plunger prior to administration. A drug in solid or powder dosage form, for example as a tablet, may be contained in a housing arranged to hold the tablet securely prior to administration.

[0084] The housing may comprise one or more medicament holders, each holder housing a dosage form, for example the medicament may be in tablet dosage form and the housing may be in the form of a blister pack with a tablet held within each of a plurality of holders.

[0085] 6 shows a housing 630 comprising multiple medication holders 610, each housing a dosage form 611. The housing 630 may have at least one environmental sensor 94 configured to sense information about the environment in which the housing 630 resides, 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 about the medication in the dosage form 611 housed within the holder 610. There may be a dedicated location sensor 98 configured to determine the geographic location of the housing 630, for example, via satellite positioning such as GPS.

[0086] The housing 630 may include an indicator 85 configured to present information to a user of the drug housing regarding the status of the drug in the dosage form 611 contained within the holder 610. The housing 630 may also include a communication interface 99 capable of communicating information to the outside world via wired or wireless transfer of data regarding the drug housing 630, the environment, time, or location, and / or the drug itself.

[0087] Optionally, the housing 630 may include a power source 95 for delivering 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 including a processor 96 and memory 97 that are powered by the power source 95 and communicate with each other and, optionally, with other electrical and control components of the housing 630, such as the environmental sensor 94, the position sensor 98, the device sensor 92, the communication interface 99, and / or the indicators 85. The processor 96 is configured to obtain data obtained from the environmental sensor 94, the device sensor 92, the communication interface 99, the position sensor 98, and / or the user interface 80, process it, and provide a data output, for example, to the indicators 85 and / or to the communication interface 99.

[0088] The housing 630 can be in the form of packaging. Alternatively, additional packaging may be present to contain and surround the housing 630.

[0089] The holder 610 or additional packaging may itself include one or more of the device sensors 92, environmental sensors 94, indicators 85, communications interfaces 99, power sources 95, position sensors 98, and a device computer system including a processor 96 and memory 97, as described above.

[0090] Electronic Communications As mentioned above, a communication interface 99 may be associated with the drug administration device 500 or the drug housing 630 by being included in or on the housing 30, 630, or alternatively in or on the packaging 35. Such a communication interface 99 may be configured to communicate with a remote computer system, such as the central computer system 700 shown in FIG. 7. As shown in FIG. 7, the communication interface 99 associated with the drug administration device 500 or the housing 630 is configured to communicate with the central computer system 700 from any number of locations, such as, for example, a medical facility 706, such as a hospital or other medical center, a home base 708 (e.g., a patient's home or office, or a caretaker's home or office), or a mobile location 710, via a communication network 702. The communication interface 99 may be configured to access the system 700 via a wired and / or wireless connection to the network 702. In one exemplary embodiment, the communications interface 99 of FIG. 6 is configured to access the system 700 wirelessly, for example, via a Wi-Fi connection, which may facilitate accessibility of the system 700 from nearly any location in the world.

[0091] Those skilled in the art will appreciate that system 700 may include security features such that the aspects of 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 that end, each user may have a unique username, password, biometric data, and / or other security credentials to facilitate access to system 700. Received security parameter information may be checked against a database of authorized users to determine whether the user is authorized and to what extent the user is permitted to interact with the system, view information stored in the system, etc.

[0092] Computer Systems As discussed herein, one or more aspects or features of the subject matter described herein, such as the components of the central computer system 700, the processor 96, the power supply 95, the memory 97, the communication interface 99, the user interface 80, the device indicators 85, the device sensors 92, the environmental sensors 94, and the position sensors 98, may 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 may include the execution of one or more computer programs executable and / or interpretable on a programmable system including at least one programmable processor, which may be a special purpose or general purpose processor connected 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 may include clients and servers. A client and server are generally remote from each other and typically interact through a communications 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 computer programs running on the respective computers and having a client-server relationship to each other.

[0093] A computer program may also be referred to as a program, software, software application, application, component, or code, and includes machine instructions for a programmable processor, and may be implemented in a high-level procedural language, an object-oriented programming language, a functional programming language, a logic programming language, and / or an assembly / machine language. As used herein, the term "machine-readable medium" refers to any computer program product, apparatus, and / or device, such as, for example, magnetic disks, optical disks, memories, and Programmable Logic Devices (PLDs), that are used to provide machine instructions and / or data to a programmable processor, including machine-readable media that receive machine instructions as machine-readable signals. The term "machine-readable signal" refers to any signal that is used to provide machine instructions and / or data to a programmable processor. A machine-readable medium may store such machine instructions non-transiently, such as, for example, a non-transient solid-state memory or a magnetic hard drive, or any equivalent storage medium. The machine-readable medium may alternatively or additionally store such machine instructions in a transitory manner, such as, for example, a processor cache or other random access memory associated with one or more physical processor cores.

[0094] To provide for interaction with a user, one or more aspects or features of the subject matter described herein, e.g., the user interface 80 (which may be integrated into the administration device 500 or the housing 630 or separate), may be implemented on a computer having a display screen, such as a Cathode Ray Tube (CRT), or Liquid Crystal Display (LCD), or Light Emitting Diode (LED) monitor, for example, to display information to a user. The display screen may allow input to the display screen 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 be used to provide interaction with a user as well. For example, feedback provided to the user may be any form of sensory feedback, such as, for example, visual feedback, auditory feedback, or tactile feedback, and input from the user may be received in any form, including, but not limited to, acoustic input, voice input, or tactile input. As discussed above, this feedback may be provided via one or more device indicators 85 in addition to the user interface 80. The device indicators 85 may interact with one or more of the device sensors 92, the environmental sensors 94, and / or the position sensors 98 to provide this feedback or to receive input from the user.

[0095] 8 illustrates an exemplary embodiment of computer system 700, shown as computer system 800. The computer system includes one or more processors 896 configured to control the operation of computer system 800. 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 one of a variety of special purpose or commercially available single or multi-processor systems. Computer system 800 also includes one or more memories 897 configured to provide temporary storage for code executed by processor 896 or for data obtained from one or more users, storage devices, and / or databases. The memory 897 may include Read-Only Memory (ROM), Flash memory, one or more of various Random Access Memory (RAM) types (e.g., Static RAM (SRAM), Dynamic RAM (DRAM), or Synchronous DRAM (SDRAM)), and / or a combination of memory technologies.

[0096] The various elements of the computer system are coupled to a bus system 812. The depicted bus system 812 is an abstraction that represents any one or more separate physical buses, communication lines / interfaces, and / or multi-drop or point-to-point connections, connected by appropriate bridges, adapters, and / or controllers. The computer system 800 also includes one or more network interfaces 899 (also referred to herein as communications interfaces), one or more input / output (IO) interfaces 880, and one or more storage devices 810.

[0097] The communication interface 899 may be configured to enable the computer system to communicate with remote devices, such as other computer systems and / or devices 500 or housing 630, over a network, or 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 for connecting the computer system 800 with 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. Additionally, the computer system may be accessible to a human user, and thus 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. Thus, the storage device 810 is configured to hold data and / or instructions in a persistent state whose values ​​are retained despite interruption of power to the computer system. Storage 810 may include one or more hard disk drives, flash drives, USB drives, optical drives, various media cards, diskettes, compact discs, and / or any combination thereof, and may be directly connected to the computer system or remotely connected to the computer system, such as over a network. In an exemplary embodiment, storage 810 includes a tangible or non-transitory computer-readable medium configured to store data, such as, for example, a hard disk drive, a flash drive, a USB drive, an optical drive, a media card, a diskette, or a compact disc.

[0098] 8 may be some or all of the elements of a single physical machine. Furthermore, all of the illustrated elements need not be located on or within the same physical machine.

[0099] 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 for those pages / streams (e.g., to complete input fields), issuing HyperText Transfer Protocol (HTTP) requests for those pages / streams or otherwise (e.g., to submit information from completed input fields to a server), etc. The web pages or other markup language may be in HyperText Markup Language (HTML) or other conventional forms including embedded Extensible Markup Language (XML), scripts, controls, etc. Computer system 800 may also include a web server for generating and / or delivering web pages to client computer systems.

[0100] As shown in Figure 7, the computer system 800 of Figure 8 may form a component 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, as described above. Data such as operational data of the device 500 or housing 630, patient medical data acquired by such device 500 or housing 630, may be exchanged between the central and device computer systems 700, 90.

[0101] As mentioned above, the above-described computer system 800 may also form a component of a device computer system 90 integrated into or proximate to the drug administration device 500 or the housing 630. In this regard, 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. Additionally, an additional storage device 810 may also be present within the device computer system 90.

[0102] In an exemplary embodiment, the computer system 800 may form a device computer system 90 as a single unit, for example housed in a single package 35 of one or more drug administration devices 500 housed in a single drug administration device housing 30, or in a housing 630 with multiple drug holders 610. The computer system 800 may form a central computer system 700 as a single unit, as a single server, or as a single tower.

[0103] A single unit may be modular such that various aspects thereof may be swapped in / out as needed, for example for upgrades, replacement, maintenance, etc., without interrupting the functioning of any other aspects of the system. Thus, a single unit may also be expandable with capabilities added as additional modules and / or additional functionality of existing modules is desired and / or improved.

[0104] The computer system may also include any of a variety of other software and / or hardware components, including, by way of example, an operating system and a database management system. While an exemplary computer system is illustrated and described herein, it will be understood that this is for the sake of generality and convenience. In other embodiments, the computer system may differ in architecture and operation from that shown and described herein. For example, memory 897 and storage 810 may be integrated together, or communication interface 899 may be omitted if communication with another computer system is not required.

[0105] Implementation In an exemplary embodiment, a drug administration device, e.g., the autoinjector 100 of FIG. 1, the infusion pump 200 of FIG. 2, the inhaler 300 of FIG. 3, the drug administration device 500 of FIG. 5, and any of the other drug administration devices described herein, are configured to electronically communicate data regarding them over a network to another device, e.g., the central computer system 700 of FIG. 7, a remote server in a cloud computing architecture, and other computer systems described herein. The data may include any of many types of information regarding the drug administration device and / or the drug that can be administered from the drug administration device, e.g., data sensed by one or more sensors of the drug administration device. In this exemplary embodiment, other devices that receive data from the drug administration device, e.g., the central computer system 700 of FIG. 7, a remote server in a cloud computing architecture, and other computer systems described herein, are configured to use the data to help improve the patient's experience of the drug administration device, the patient's experience of the drug, other patients' experience of the same type of drug administration device, other patients' experience of the same drug, and / or other patients' experience of a different drug.For example, the central computer system 700 of FIG. 7 , other devices such as remote servers in a cloud computing architecture, may be configured to analyze data received from the drug administration device in various ways to help achieve one or more of these goals by any one or more of: correlating a patient's drug usage with the patient's clinical outcomes; performing cost analyses including comparing the patient's clinical outcomes with 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 malfunctions 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 transmitted wirelessly from the other device to the drug administration device; and creating predictive models of the patient's clinical outcomes. For example, other devices, such as the central computer system 700 of FIG. 7, e.g., a remote server in a cloud computing architecture, may also be configured to receive data sensed by one or more sensors of each of multiple additional drug administration devices to increase the data set available for analysis and thus improve the overall analysis by having a larger data set.

[0106] As mentioned above, any of a variety of drugs can be delivered using the drug administration device. Examples of drugs that can be delivered using the drug administration device described herein include Remicade® (infliximab), Stelara® (ustekinumab), Simponi® (golimumab), Simponi Aria® (golimumab), Darzalex® (daratumumab), Tremfya® (guselkumab), Eprex® (epoetin alfa), Risperdal Constra® (risperidone), Invega Sustenna® (paliperidone palmitate), Spravato® (esketamine), ketamine, and Invega Trinza® (paliperidone palmitate).

[0107] For example, a drug administration device providing data to another device, such as the central computer system 700 of Figure 7, e.g., a remote server in a cloud computing architecture, may provide any of a number of advantages that may not be easily achieved or at all if the data is not available or collected in another manner. For example, a patient manually reporting information regarding the drug administration device and / or drug use may result in communication of information that is delayed from the time of drug delivery and may not include all relevant information in sufficient detail due to the patient's erroneous memory of the details and / or the patient's inability to accurately observe the information.

[0108] In another example, data may be communicated from the drug administration device to other devices, such as the central computer system 700 of FIG. 7, e.g., a remote server in a cloud computing architecture, according to a predetermined automated schedule, thereby helping to ensure that all relevant data is received by the other devices in a predictable and timely manner.

[0109] In yet another example, data may be communicated from the drug administration device to other devices, such as the central computer system 700 of FIG. 7, e.g., a remote server in a cloud computing architecture, and automatically uploaded to the patient's Electronic Health Record (EHR) and / or to forms required for use with a particular drug, such as a Risk Evaluation and Mitigation Strategy (REMS) for a particular drug, e.g., a patient monitoring form for a REMS for esketamine, ketamine, or other controlled substances. Thus, the EHR and / or forms may be updated accurately and in a timely manner.

[0110] FIG. 9 illustrates one embodiment of a method 900 for updating a patient monitoring form with data sensed by one or more sensors and identifying one or more abnormal sensed parameters. The patient monitoring form may be updated with other data as well, such as data input into a user interface of the drug administration device. For example, psychological state data may be collected in a variety of ways, such as through the patient's answers to survey questions stored on an external device, through user input to one or more questions presented through a user interface of the drug administration device, such as answers to a psychological stress test, such as the Kessler Psychological Distress Scale (K10) or any of a variety of other indices and scales, through a healthcare provider's assessment notes about the patient stored on an external device, and the like. The psychological state data may be used, for example, by a processor, to evaluate when a drug should be delivered from the drug delivery device 500 to the user and to determine how the user is responding to a current treatment. For example, a trend toward improved psychological state may indicate an effective drug treatment for depression, such that the drug dosage and / or drug administration frequency may be reduced. In another example, a declining trend in a mood state or a static trend in a mood state may indicate that for a drug treating depression, the drug dosage and / or drug administration frequency should be increased.

[0111] In this exemplary embodiment, the sensed parameters include the patient's Heart Rate (HR), the patient's Respiratory Rate (RR), and the patient's Blood Pressure (BP), although other conditions may be sensed as discussed herein. One or more sensors collect data 902, and the drug administration device communicates the sensed data to computer system 700 (or other devices discussed herein) 904. Computer system 700 enters the received sensed data into a patient monitoring form that it temporarily holds 906. For each sensed parameter, computer system 700 determines whether the sensed data is above a predetermined maximum threshold or below a predetermined minimum threshold, as appropriate for the particular condition being measured. If not, the sensed data is deemed normal, e.g., within acceptable limits, and computer system 700 enters 908 the sensed data for that sensed condition into the patient monitoring form. If so, the sensed data is deemed abnormal, e.g., not within acceptable limits. The computer system 700 determines whether this abnormality determination is a first determination of abnormality for this sensed parameter for this patient. If this abnormality determination is a first determination of abnormality for this sensed parameter for this patient, the patient monitoring form is not yet populated with the sensed data 908. Instead, after the parameter is sensed again 902, the computer system 700 receives the sensed parameter data and populates the patient monitoring form that temporarily holds the received sensed data 906. If the computer system 700 determines that the sensed data is above a predefined maximum threshold or below a predefined minimum threshold, as appropriate, for the particular condition being measured, such that it is a second instance of abnormal sensed data for the sensed condition, the computer system 700 provides an alert 910 to medical personnel, e.g., staff on-site with the patient using the medication administration device, the patient's medical provider, etc., for evaluation and possible intervention.The alerted medical personnel confirms 912 the anomalous sensory data, e.g., by manually reviewing the data on a display screen of the computer system 700, and causes the sensory data to be entered 908 into a patient monitoring form, e.g., by providing an input to a user interface of the computer system 700 that triggers 908 the entry. Human review of the sensory data and confirmation of the anomalous sensory data by medical personnel may help enable insurance reimbursement since human activity is involved. If the computer system 700 determines that the sensory data is neither above a predetermined maximum threshold nor below a predetermined minimum threshold, as appropriate for the particular condition being measured, then the first anomaly determination is deemed anomalous, and the computer system 700 enters 908 the sensory data into a patient monitoring form for that sensed condition.

[0112] In other embodiments of method 900, the temporarily stored patient monitoring form may be omitted. In such embodiments, the patient monitoring form may be populated 908 with all sensory data, even sensory data that is initially determined to be abnormal, thereby providing a more complete patient record.

[0113] In other embodiments of method 900, medical personnel may be alerted to the first abnormal sensed condition, which may help enable medical intervention to be provided more quickly in an emergency.

[0114] In another example, data may be communicated from the drug administration device to another device, such as the central computer system 700 of FIG. 7, e.g., a remote server in a cloud computing architecture, indicating that the drug has been administered from the drug administration device. In response to receiving the data, the other device may be configured to automatically trigger the mailing (or other delivery, as appropriate) of a new drug administration device to the patient (or to another location for the patient to pick up or use, as appropriate) so that the new drug administration device is available for use before the next scheduled drug dose occurs and / or so that the patient has a limited supply of drug on hand at any given time. Having a limited supply of drug on hand at any given time may be particularly important in the case of controlled substances that may be abused and / or that are more prone to addiction than other drugs. In response to receiving the data, the other device may be configured to automatically trigger mailing (or other delivery, as appropriate) of one or more items in addition to or instead of a new drug administration device, such as accessories configured to be used before, during, and / or after drug administration, external devices that are external to and separate from the drug administration device, such as questionnaires or other forms to be filled out by the patient before, during, and / or after drug administration.

[0115] In yet another example, some types of information may be difficult or impossible for a user of the drug administration device to detect, such as the exact amount of drug delivered to a patient in one dose, the temperature of the drug, the GPS location of the patient when the dose of drug is delivered to the patient, etc. However, as discussed herein, sensors on the drug administration device may be configured to sense information that is difficult or impossible for a user of the drug administration device to detect, thus allowing this data to be taken into account in analyses performed by other devices.

[0116] In yet another example, the drug administration device may be one of a plurality of drug administration devices all providing the same one or more types of sensory data to other devices, such as the central computer system 700 of FIG. 7 , e.g., a remote server in a cloud computing architecture, thereby enabling the other devices to predictably receive multiple data sets that can be compared with each other to enable a medical professional to develop a patient treatment plan, modify an existing patient treatment plan, select a drug for the patient, adjust the time the patient should be monitored for side effects after drug administration, determine when a plurality of used drug administration devices are ready for recall, a plurality of drug administration devices have been in the field for a predetermined time (e.g., one week, two weeks, one month, etc.) and, whether used or not, provide useful data in determining when a plurality of drug administration devices are ready for recall and / or selecting a drug administration device for a patient. Some drug administration devices may be required or recommended to be collected by an authorized agency after use for recycling and / or to help ensure that any drug remaining in the drug administration device (whether because the drug administration device was not used or because drug was left in the drug administration device after use) is safely disposed of and not accessed by any unauthorized person, which may be particularly important in the case of esketamine, ketamine, and other controlled substances. Collecting multiple drug administration devices at once is more efficient than collecting them one by one. Administration of some medications, such as controlled substances and / or medications with known adverse side effects such as somnolence, sleep, etc., may require the patient to be monitored for a minimum period of time (e.g., 1 hour, 90 minutes, 2 hours, 4 hours, etc.) after drug administration to help ensure that any side effects of the drug delivered from the drug administration device have dissipated before the patient drives or otherwise leaves the location of drug administration (e.g., driven by others, walking, etc.), so that multiple data sets from multiple patients can help determine whether the minimum period is too long for all patients or too short for all patients.Similarly, multiple data sets for a particular patient can help determine whether the minimum period is too long or too short for that particular patient. If the minimum period of patient monitoring could be reduced, it could improve the patient experience and / or reduce the time and / or cost burden on medical professionals and / or medical facilities.

[0117] 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 that is external to and separate from the drug administration device may include at least one of the sensors. In general, the external device includes a communication interface configured to communicate with the system 700, similar to the communication interface of the drug administration device that includes a computer system as described herein and is configured to communicate with the system 700. Some external devices are specifically designed for communication with the drug administration device, while other external devices (e.g., smartphones, smart watches, heart rate monitors, blood glucose monitors, blood pressure monitors, etc.) only allow other devices, such as the system 700, to communicate with them. An external device that includes at least one of the sensors may help offload some data collection and transmission from the drug administration device and / or enable sensing capabilities that would otherwise be unavailable if only using the sensors of the drug administration device. In yet other embodiments, the external device includes one or more sensors. An external device including one or more sensors may offload data collection and transmission from the drug administration device and / or enable sensing capabilities that would not otherwise be available when using only the sensors of the drug administration device.

[0118] The sensors described herein may be configured to collect data regarding various conditions, such as device conditions (e.g., sensed by device sensors 92), environmental conditions (e.g., sensed by environmental sensors 94), and location conditions (e.g., sensed by location sensor 98). Examples of conditions include geographic location (e.g., sensed by a GPS or other location sensor configured to sense location), time (e.g., sensed by a clock device such as a timer or atomic clock), date (e.g., sensed by a timer), temperature (e.g., sensed by a temperature sensor), ultraviolet (UV) exposure (e.g., sensed by a UV sensor configured to sense UV levels), humidity (e.g., sensed by a humidity sensor configured to sense humidity levels), pressure (e.g., sensed by a pressure sensor), angular velocity (e.g., sensed by an Inertial Measurement Unit (IMU)), and the like. These may include, for example, a respiratory rate (sensed by an Impedance Measurement Unit (IMU) or a Magnetic, Angular Velocity and Gravity (MARG) sensor), body orientation (e.g., using an IMU, etc.), motor current used in delivering the drug (e.g., using a current sensor), blood oxygen level (e.g., using a blood oxygen sensor), sunlight exposure (e.g., using a UV sensor, etc.), osmolality (e.g., using a blood monitor, etc.), blood glucose level (e.g., using a glucose monitor, etc.), blood pressure (e.g., using a blood pressure monitor, etc.), sweat level (e.g., using a fluid sensor, etc.), heart rate (e.g., using a heart rate monitor, etc.), respiratory rate (e.g., using a respiratory monitor, a thermal sensor located near the nose or mouth and configured to use heat detection on the exhaled breath or to detect the movement of the inflow / outflow airflow, a pressure sensor located near the nose or mouth and configured to use pressure detection on the exhaled breath or to detect the movement of the inflow / outflow airflow, a spirometer, etc.), and air quality (e.g., using a UV 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 videos captured by the image capture device, such as to analyze the patient's respiration, the patient's eye dilation, the patient's sedation, the patient's dissociation, the patient's voice characteristics such as tone and pitch, any food intake, and / or the patient's skin reaction to medications. U.S. Patent Publication No. 2012 / 0330684, published Dec. 27, 2012, entitled "Medication Verification And Dispensing," the disclosure of which is incorporated herein by reference, further describes image capture devices. U.S. Patent Publication No. 2002 / 0014951, published February 7, 2002, entitled "Remote Control For A Hospital Bed," and U.S. Patent Publication No. 2007 / 0251835, published November 1, 2007, entitled "Subnetwork Synchronization And Variable Transmit Synchronization Techniques For A Wireless Medical Device Network," the disclosures of which are incorporated herein by reference, further discuss various sensors.

[0119] Using the drug administration device 500 of Fig. 5 as an example for clarity and ease of description of implementations provided herein, the drug administration device 500 may be configured to transmit data indicative of information sensed by one or more sensors 92, 94, 98 of the device automatically according to a predetermined schedule, such as, for example, transmitting data every hour, every 3 hours, every 12 hours, once a day, every time the device 500 delivers a dose, every other time the device 500 delivers a dose, etc. In this manner, the system 700 may periodically receive data for analysis, and neither the user of the device 500 nor the system 700 need to prompt for the data transmission. The predetermined schedule may be programmed into the memory 97 of the drug administration device, in which case the device 500 transmits data without prompting from the system 700, or the predetermined schedule may be programmed into the system 700, in which case the system 700 transmits a request for data to the device 500, and the device 500 transmits the data in response to the system 700. In one exemplary embodiment, the predetermined schedule is the same for all sensed data, which may help conserve power and resources of the device, but the predetermined schedule may be different for data monitored by different sensors 92, 94, 98 of the device 500, which may help the system 700 have more time available for analysis.

[0120] In some embodiments, the predetermined schedule may be fixed such that the predetermined interval between data transmissions is always the same, which may help ensure predictably collected data. In some embodiments, the predetermined schedule may be variable such that the predetermined interval between data may change over time, which may 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 particular condition being measured, the schedule may 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 may be received more frequently, which may allow for earlier identification of out-of-range data as being "freak" readings that are not cause for concern, and earlier identification of problematic trends that should be communicated to the patient and / or medical personnel to take action as necessary. For example, a patient's blood pressure reading may exceed a predetermined maximum threshold blood pressure value, thereby triggering a change in the predetermined interval, resulting in new blood pressure data being transmitted sooner than would otherwise have been received and analyzed. In 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 so that new heart rate data is transmitted sooner than it would otherwise have been received and analyzed. In yet another example, a patient's respiration rate measurement may fall below a predetermined minimum threshold respiratory rate value, thereby triggering a change in the predetermined interval so that new respiration rate data is transmitted sooner than it would otherwise have been received and analyzed.

[0121] In addition or as an alternative to the drug administration device 500 being configured to automatically transmit data indicative of information sensed by one or more sensors 92, 94, 98 of the device, the drug administration device 500 may be configured to transmit data to the system 700 on demand in response to a request for data from the system 700 to the device 500. Transmitting data on demand may help to conserve power and resources of the device and / or ensure that the system 700 receives only data necessary to perform a particular analysis. The system 700 may be configured to transmit requests to the device 500 according to a predetermined schedule, such as, for example, 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 to the system 700 requesting that the device 500 be queried about sensed data. Similar to what was discussed above with respect to the drug administration device 500 being configured to transmit data according to a variable or non-variable schedule, the schedule for transmitting requests from the system 700 to the device 500 may be variable or non-variable.

[0122] In addition to or as an alternative to the drug administration device 500 being configured to automatically transmit data indicative of information sensed by one or more sensors 92, 94, 98 of the device, the drug administration device 500 may be configured to transmit data to the system 700 on demand, for example, after a user input to the system 700 via the user interface 80 of the drug administration device. Transmitting data on demand may help ensure that the system 700 receives data in a timely manner to perform a particular analysis. The system 700 may be configured to transmit a request to the device 500 according to a predetermined schedule, for example, transmitting data every hour, every three hours, every 12 hours, once a day, etc., and / or may be configured to transmit a request in response to a user input to the drug administration device 500. The user input to the drug administration device 500 may indicate that the patient is experiencing side effects following drug delivery and would like to consult a medical professional. In other embodiments including at least one external device, the user input may instead be provided to the external device.

[0123] The system 700 may be configured to store data received from the device 500 for analysis at a subsequent time. For example, the system 700 may be configured to perform an analysis on demand in response to a user input to the system 700 requesting one or more types of analysis, such as any one or more of the analyses discussed further below. Performing an analysis on demand may help conserve system power and resources and / or help ensure that a user receives an analysis output from the system 700 based on the most recent data available to the system 700. In another example, the system 700 may be configured to perform the analysis automatically according to a predetermined schedule, such as analyzing data every hour, every three hours, every twelve hours, once a day, when the system 700 has received a predetermined number of data transmissions from the device 500 such that the system 700 has a sufficient amount of new data to include in the analysis, etc. Additionally or alternatively, the system 700 may be configured to perform an analysis in response to receiving data from the device 500, such as performing an analysis every time the system 700 receives a particular type and / or amount of data from the device 500. Receipt of data as a trigger for analysis may help to more quickly identify problems with the drug administration device 500 and / or the drug, which may in turn allow the problem to be addressed more quickly by a medical professional and / or user of the device 500.

[0124] In general, the analyses performed by the system 700 use sensed information from the drug administration device 500 and, for at least some analyses, one or more additional drug administration devices 500. In an exemplary embodiment in which the system 700 analyzes 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 drug, and / or delivers the same drug. Thus, the analyzed data may yield important and meaningful results regarding a particular type of drug administration device, a particular type of drug, and / or a particular drug. The data collected by the system 700 from multiple devices 500 may each indicate the same type of sensed information, such as, for example, drug temperature information, GPS information, administration timing information, etc. The collection of the same type of information from multiple devices 500 may allow the system 700 to continually review the data to find trends in the data between patients and to correlate these trends to patient type, drug administration device type, and functional outcomes. These relationships can be evaluated by the system 700 via multiple algorithms to provide more accurate trends and / or more accurate recommendations, such as recommendations for treating the patient and the patient's condition to result in optimized outcomes, recommendations that result in cost savings, recommendations that result in fewer and / or less severe side effects.

[0125] In general, data transmitted from the drug administration device 500 and / or drug 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, drug 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.

[0126] In one implementation, the system 700 may be configured to receive data transmitted from the drug administration device 500 and process the data to correlate a patient's drug usage with a clinical outcome. A clinical outcome generally includes a measurable change in health, function, or quality of life status that may occur as a result of a clinical treatment, such as administering a drug or receiving a therapeutic treatment. A clinical outcome may be determined based on data received from a patient in response to a prompt, such as a questionnaire or other similarly formatted self-report assessment. A clinical outcome may also be determined based on data collected from a patient and provided by a medical professional. Clinical outcome data may be stored in a database, such as a patient's medical file, a hospital information system, or the like, and may be transmitted and / or stored in the memory of the system 700. Although the above describes collecting clinical outcome data via patient self-report or by a healthcare provider as input into a form or questionnaire, such as a health assessment form, that may be implemented on an app configured on a mobile computing device, those skilled in the art will understand that clinical outcome data may be captured in other ways, and that devices other than a mobile computing device may be used to collect clinical outcome data, with or without running an app. Those skilled in the art will appreciate that data may be captured in a variety of ways, such as using one or more sensors (e.g., gyros, accelerometers, Global Position System (GPS), images (e.g., camera or video camera), etc.), such as a camera (standalone or integrated into another device such as a cell phone or tablet), a video camera (standalone or integrated into another device such as a cell phone or tablet), on a smartphone, in a skin patch (e.g., patches available from MC10 Inc. of Cambridge, Mass.), integrated into smart clothing, or in additional sensing or monitoring devices that may connect to the drug administration device 500 or system 700 via a wireless or wired connection, as well as any of a variety of known motion capture apps or software.Further information regarding collecting clinical outcomes and patient data is provided in U.S. Patent Publication No. 2014 / 0081659, published March 20, 2014, entitled "Systems and Methods for Surgical and Interventional Planning, Support, Post-operative Follow-up, and Functional Recovery Tracking," which is incorporated herein by reference in its entirety.

[0127] Once received by the system 700, the clinical outcome data may be aggregated with data received from the drug administration device 500 and / or drug 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 received from the drug administration device 500 and / or drug housing 630 and the clinical outcome data. Additionally, the system 700 may receive data from one or more additional drug administration devices 500 and / or drug housings 630 to identify trends and correlations among patient populations.

[0128] Such correlations may be determined, for example, by a server configured in the system 700 to include one or more data processing components, each associated with a data processor and implementing an artificial intelligence and machine learning system. 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 representation of the data patterns. Machine learning is commonly used in pattern recognition, computer vision, language processing, and optical character recognition, and allows for the construction of algorithms that can accurately learn from data and predict model outputs, thereby making data-driven predictions or decisions. Machine learning may be utilized to develop predictive models that can generate clinical outcomes associated with one or more aspects of a patient's treatment, such as the patient's use of a drug administration device and the patient's suitability for a particular drug delivery schedule.

[0129] The artificial intelligence and machine learning system configured in the system 700 may include one or more predictive models or algorithms trained with machine learning processes or implementing a layered structure of deep learning algorithms, also known as artificial neural networks, that may continuously analyze data using an artificial neural network to generate predictions. The system 700 may perform untrained or deep learning to predict clinical outcomes based on device usage and drug delivery data received from the drug administration device 500 and / or the drug housing 630 (and / or the additional drug administration device 500 and / or the drug housing 630). In this manner, features of the device usage or drug delivery data may be used to accurately predict certain clinical outcomes. For example, an artificial neural network may process insulin syringe usage data of a diabetic patient indicating that the patient adequately adhered to the prescribed twice-daily insulin delivery timing, and determine a predicted clinical outcome indicating that the patient is unlikely to receive a protective reduction in hyperglycemic levels. Further information regarding implementing neural networks is provided in U.S. Patent Publication No. 2018 / 0189638, published July 5, 2018, entitled "Hardware Accelerator Template Design Framework For Implementing Recurrent Neural Networks," which is incorporated by reference in its entirety.

[0130] The artificial intelligence and machine learning systems configured within system 700, each of which may include data processing components associated with a data processor, may perform trend analyses that may identify trends and variations in device usage and drug delivery data over time. The trend analyses may include time series data associated with how self-reported or predicted clinical outcomes change over time. The trend analyses may be compared to desired or predetermined patterns of device usage and drug delivery data, as well as desired or predetermined patterns of clinical outcome data. Such determinations may be made regarding compliance with drug administration over time and predicted clinical outcomes that may occur based on compliance determinations. Assessing compliance may thus enable monitoring and management of a patient's treatment, which may help the patient's physician (and / or other medical professional) evaluate the patient's medical progress and / or determine whether and when modifications to the patient's treatment plan may be necessary, 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 delivery device 500, changing dietary requirements, changing the frequency of physician visits, changing the amount of patient monitoring time required after delivering a drug dose, allowing the patient to receive drug doses at home instead of only being allowed to receive drug doses under the supervision of a physician at a hospital or other medical facility, etc.), or replacing a treatment plan (e.g., a treatment that includes the use of a drug administration device 500 to deliver a particular drug) with another treatment plan (e.g., a treatment that does not include the use of the drug administration device 500 and / or a particular drug at all). Further information regarding compliance determinations is provided in the aforementioned U.S. Patent Publication No. 2014 / 0081659, published March 20, 2014, and entitled "Systems And Methods For Surgical And Interventional Planning, Support, Post-Operative Follow-Up, And Functional Recovery Tracking."

[0131] For example, a patient's compliance 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) may be compared to historical compliance data of other patients who have used the same type of drug administration device 500 and / or received the same drug to help determine the effectiveness of the patient's drug administration device 500 and / or drug. This comparison enables the system 700 to determine whether the patient is adequately following the treatment plan or is falling behind historical benchmarks achieved by other patients undergoing treatment. This comparison may enable system 700 to evaluate treatment options for future patients, such that if a treatment has been historically shown to be problematic for any one or more reasons (e.g., difficulty in achieving patient compliance, slow progress in addressing symptoms, high 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 eventually disappears, etc.), system 700 may be more likely (in the case of a particularly effective treatment) or less likely (in the case of a problematic treatment) to recommend that treatment to future patients.

[0132] Because the system 700 may be configured to simultaneously and continuously receive information about multiple patients from multiple drug administration devices 500, the system 700 may repeatedly analyze the received data to help determine the effectiveness of a particular patient's treatment plan, including the use of the same type of drug administration device 500 and / or the use of the same drug as other patients. Thus, the system 700 may determine that a particular patient's treatment plan should be modified based on another set of data of patients showing lower or higher effectiveness for that type of drug administration device 500 and / or that drug. In other words, the system 700 may learn from the experience of other patients that the treatment of this patient could benefit from modifications, such as, for example, using a different type of drug administration device 500 with a lower failure rate and / or higher compliance rate, prescribing a different drug, increasing or decreasing the frequency of administration, decreasing the required patient monitoring time after delivery of a drug dose, etc. The system 700 may be configured to suggest modifications to the patient's treatment plan to the patient's care provider, for example, by providing an alert (e.g., an email message, a text message, an instant message, a phone call, etc.) to the care provider indicating that a modification to the patient's treatment plan is recommended. The care provider may review the modifications and decide whether to modify the patient's treatment plan, for example, by logging on to the system 700 and / or a computer system in communication therewith. Alternatively, the system 700 may be configured to automatically modify the patient's treatment plan and notify the patient and / or the patient's care provider via an alert regarding the modified treatment plan. Typically, however, the care provider will review the modifications to check their appropriateness for a particular patient before the system 700 automatically modifies the patient's treatment plan and notifies the patient of the changes.

[0133] The artificial intelligence and machine learning system configured in the system 700 may include data processing components, each associated with a data processor, to monitor the effectiveness of the drug delivered via the drug administration device 500 and / or the drug housing 630 (and / or the additional drug administration device 500 and / or the drug housing 630). In at least some embodiments, the system 700 may be configured to process the clinical outcome data and the aggregated device usage and drug delivery data to determine how well the drug provides therapeutic benefit and whether the drug causes the patient to experience any side effects that may be reported via the clinical outcome data. For example, the system 700 may determine a correlation between a particular drug (or a particular drug delivery schedule) and self-reported symptoms of nausea. The system 700 may further process data associated with the medical history of an individual patient to determine an appropriate dosage or delivery schedule that is less likely to cause nausea. In this manner, new drugs or drug delivery regimens that produce desired clinical outcomes for a patient population may be determined. In another example, the system 700 may determine that patients who received a different drug than the drug delivered to the patient did not experience side effects experienced by the patients who received the drug, and / or experienced side effects to a lesser extent than the patients who received the drug. Thus, the system 700 may determine that the drug received by the other patient would be a good alternative to suggest to the patient who received the drug to stop the patient from experiencing side effects or to reduce the severity of the side effects. In yet another example, the system 700 may determine that one or more side effects of a particular drug, such as, for example, drowsiness, nausea, vomiting, etc., were experienced by a particular patient during patient monitoring but after the required patient monitoring time has elapsed after delivery of each of a plurality of drug doses. Thus, the system 700 may determine that the required patient monitoring time after delivery of a dose of a particular drug should be increased for this particular patient. In another example, the system 700 may determine that one or more side effects of a particular drug, such as, for example, drowsiness, nausea, vomiting, etc., have not been experienced by a particular patient past a particular point during the required patient monitoring time following delivery of a drug dose.Thus, the system 700 may determine that the patient monitoring time required after delivery of a dose of a particular drug should be decreased for this particular patient. In yet another example, the system 700 may determine that one or more side effects of a particular drug, such as, for example, drowsiness, nausea, vomiting, etc., were not experienced by any patient past a certain point during the patient monitoring time required after delivery of the drug dose. Thus, the system 700 may determine that the patient monitoring time required after delivery of a dose of a particular drug should be decreased for all patients. In yet another example, the system 700 may determine that one or more side effects of a particular drug, such as, for example, drowsiness, nausea, vomiting, etc., were experienced by many patients during patient monitoring but after the patient monitoring time required after delivery of the drug dose. Thus, the system 700 may determine that the patient monitoring time required after delivery of a dose of a particular drug should be increased for all patients.

[0134] In some embodiments, the system 700 may be configured to electronically transmit instructions to the drug administration device 500 and / or the drug housing 630 based on the system's analysis of previously received data. The drug administration device 500 and / or the drug housing 630 may be configured to execute the received instructions on the drug administration device 500 and / or the drug housing 630 to alter at least one aspect of the device's / housing's functionality. Thus, the system 700 may be configured to remotely control the drug administration device 500 and / or the drug housing 630.

[0135] For example, the instructions from the system 700 may include a request for the device 500 or housing 630 to change the predetermined schedule according to which data sensed by one or more sensors is transmitted to the system 700 in embodiments where a predetermined schedule is programmed into the memory 97 of the drug administration device 500 or drug housing 630. The request may be transmitted on demand, for example, because a physician or other medical professional reviewing information about the drug administration device 500 or drug housing 630 collected by the system 700 may desire more frequent sensed information to facilitate the physician's or other medical professional's analysis of the patient's treatment plan and the system 700 may input a request to update the device's / housing's stored predetermined schedule. The request may be transmitted automatically, for example, in response to the received data being above a predetermined maximum threshold or below a predetermined minimum threshold, as described above.

[0136] In another example, the command from the system 700 may include a request for the drug administration device 500 or the drug housing 630 to change the functionality of the drug delivery, such as the delivery schedule of the drug, the drug infusion rate, and the administration of the delivered dose. A physician or other medical professional reviewing information about the drug administration device 500 or the drug housing 630 collected by the system 700 may desire the functionality of the drug delivery changed based on the information review. More specifically, an algorithm stored in the memory 97 of the drug administration device 500 or the drug housing 630 may be executed on-board by the processor 96 to administer a dose of the drug to the patient. The algorithm is stored in the form of one or more sets of a plurality of data points that define and / or represent instructions, notifications, signals, etc., to control the function of the device and the administration of the drug. Data received by the drug administration device 500 or the drug housing 630, e.g., as a plurality of data points via their communication interface, is used, e.g., by the processor 96, to change at least one variable parameter of the algorithm based on the received command identifying the parameter to be changed and the updated value of the parameter. At least one variable parameter is between the data points of the algorithm, e.g., included in the instructions for drug delivery, and thus each can be changed by changing one or more of the stored data points of the algorithm. After the at least one variable parameter is changed, a subsequent execution of the algorithm administers another dose of the drug according to the changed algorithm. Thus, drug delivery over time can be remotely managed for the patient, e.g., by a medical professional providing inputs for changes in drug delivery to the system 700, to increase the beneficial outcome of the drug. The change in the at least one variable parameter and / or the administration of one or more doses themselves is automated to improve patient outcomes. Thus, the system 700 can be configured to facilitate patient-based personalized medicine and provide a smart system for drug delivery.

[0137] 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 medical care to a patient. The received financial data may be used in a cost-effectiveness analysis of various drugs or treatment regimens that may be prescribed for a particular patient. The financial data may include payer, insurance, and / or hospital cost data, and when analyzed with respect to device usage and drug delivery data and clinical outcome data, may provide insights regarding lower cost alternatives to a drug that provide substantially the same clinical outcome as the drug. For example, a particular drug may be associated with a lower insurance reimbursement rate and / or lower hospital costs than other drugs, where each of the drugs are used to treat the same medical problem (e.g., blood pressure, asthma, etc.) and each had substantially similar clinical outcomes associated therewith. Thus, drugs with higher insurance reimbursement rates and / or higher hospital cost rates may be identified by system 700 as more financially sound options for patients currently receiving other drugs as part of the patient's treatment plan. One of ordinary skill in the art will appreciate that the clinical outcomes may not be exactly the same, but may nevertheless be considered to be substantially the same as one another for any number of reasons, such as due to statistical standard deviations.

[0138] The system 700 may be configured to perform using the aggregated data to create a predictive model of drug delivery suitability and resulting clinical outcome for a particular patient based on assumption parameters that may be provided to the system 700 by the patient's physician and / or other caregiver. The artificial intelligence and machine learning system configured within the system 700 may include data processing components configured to implement a trained machine learning process to generate a predictive model that may receive input parameters associated with device usage or drug delivery data and predict clinical outcomes based on the input. Once trained during the training phase of the machine learning process, the predictive model may be deployed within the system 700 as a trained predictive model and may be accessed via a user interface, such as a web-based application configured on a web browser of a computer system at the medical facility 706 or via a user interface, such as an app configured on a smartphone or other mobile computing device at the mobile location 710. The interface to the trained predictive model may allow a user to input data parameters for a particular patient associated with a particular treatment. The input parameters may include any one or more of parameters related to, for example, drug delivery schedules, drug dosages, drug types, device types, etc. The trained predictive model may process the input and provide the user with predicted clinical outcomes, predicted side effects, and / or other predicted behavioral or physiological changes that are predicted to become symptomatic for a particular patient based on the input. In this manner, the system 700 may improve the ability of a physician or other care 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.

[0139] The system 700 may be configured to receive data transmitted from the drug administration device 500 and process the data with respect to data and metadata associated with a medical professional summary of the patient's treatment over time recorded in the patient's medical history file. The system 700 may be configured to receive the physician summary data or metadata from a hospital information system as the physician summary data is entered into the patient's medical history file. The system 700 may be configured to analyze the physician summary data with respect to the data transmitted from the drug administration device 500 such that the patient's adherence to a prescribed drug regimen or treatment treatment may be determined in real time or near real time. In this manner, analysis and reporting of adherence trends may be performed more quickly than in systems that may not receive device usage and drug delivery data or integrate medical professional summary data configured within the system 700.

[0140] Receiving the physician summary data as it is recorded in the patient's medical history file (e.g., in the patient's EHR) and / or in the patient's patient monitoring form enables the system 700 to generate a notification immediately upon a non-compliance condition being determined. The notification may be generated as a warning or alarm that may be sent to one or more computer systems to notify the patient, the patient's physician, and / or other appropriate medical professionals that the patient is experiencing a non-compliance issue or other medical condition that requires immediate attention. The notification may enable the physician and / or appropriate medical professionals to quickly instigate action to mitigate or reduce the non-compliance condition.

[0141] In at least some embodiments, the system 700 may include one or more data filters that may be applied to the data transmitted from the drug administration device 500 and the aggregated physician summary data. The data filters may include filters for analyzing the aggregated data based on geographic region, age, genetic profile, and / or ethnicity, for example, such that significant trends associated with patients contained in the filtered data may be determined.

[0142] The system 700 may be configured to receive data transmitted from the drug administration device 500 and process the data automatically and in real-time or near real-time to determine a complaint associated with the device 500. The system 700 may process the received device usage data to determine a malfunction of the device 500 and generate a complaint based on the malfunction. For example, device usage data received from the drug administration device 100 of FIG. 1 may indicate to the system 700 that the discharge nozzle 122 was unable to extend from the housing 130 during an injection sequence, and therefore the drug could not be delivered to the patient. In another example, device usage data received from the drug administration device 100 of FIG. 1 may indicate to the system 700 that a user error occurred that affected drug delivery, such as the time between two nasal sprays was too short, such that the first nasal spray may not have been adequately absorbed, the needle of the autoinjector was withdrawn too soon after the start of drug delivery, such that the patient may not have received the full amount of drug intended, or the drug was not allowed sufficient time to warm to room temperature after being removed from a refrigerated warehouse. The complaint may be generated as a warning or alarm that is sent to one or more computer systems to notify the patient, the patient's physician, and / or other medical professionals of the device malfunction. Based on the generated complaint, the system 700 may further notify the drug delivery device manufacturer 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 a warning or alarm are further described in U.S. Patent Publication No. 2008 / 0154177, published June 26, 2008, entitled "System And Method For Remote Monitoring And / Or Management Of Infusion Therapies," which is incorporated herein by reference in its entirety.

[0143] The system 700 may be configured to generate malfunction reports pre-populated with patient-specific device data describing the configuration of a malfunctioning drug administration device. In this manner, the system 700 may assist in diagnosing device quality assurance issues while ensuring that patients can maintain their prescribed drug delivery schedules using a functioning drug administration device that may be provided as a replacement for the malfunctioning device.

[0144] The system 700 may be configured to respond to requests for additional data received from a remote location, such as the mobile location 710 of FIG. 7. 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 drug delivery device 500 or multiple drug delivery devices 500 to better understand certain trends, previous cost conclusions, or other previous analysis output of the system 700, to trigger the collection of a certain type of data not previously received by the system 700 so that this type of data may be included in the system's analysis, to help determine whether a malfunction identified in a particular drug delivery device 500 is specific to that device 500 or may be an issue related to a group of related drug administration devices 500, etc. For example, a request for additional data may include a request for data associated with a particular patient's drug delivery device 500 or the configuration of the patient's device 500, such as a particular drug contained within the device 500, or specifications of a particular 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 patient device 500, such as device model numbers, manufacturing lot numbers, and data identifying or otherwise associated with the patient population for which drug administration device 500 is prescribed for use. In yet another example, a request for additional data may include a request for data associated with a particular drug that may be administered by drug administration device 500, or a class of drug administration devices, including drug administration device 500, such as formulation, administration data, drug type or class, and characteristics associated with the administration method of drug administration device 500, which may include, for example, in the case of a syringe-type device, the viscosity of the administered drug.

[0145] The system 700 may be configured to aggregate data received from the drug administration device 500 with clinical outcome data to detect irregular treatment conditions of a particular treatment prescribed to be performed using a particular configuration of the drug administration device 500. For example, irregular treatment conditions may include irregular administration events, unprescribed administration timing intervals, and indicators of negative clinical outcomes. The system 700 may utilize the aggregated data to identify when a particular treatment is being performed away from prescribed or expected treatment parameters and generate suggestions that are likely to improve the clinical outcome experienced by the patient. The generated suggestions may include actions to be performed when the system 700 determines that an irregular treatment condition is associated with a better than expected clinical outcome. For example, if the system 700 determines that a patient's irregular treatment condition results in an improved clinical outcome, the system 700 may mark the improved clinical outcome in a database and initiate a search for data that may support or refute the unexpected improvement in clinical outcome. The system 700 may be configured to analyze the search results, for example, using natural language processing. If the system 700 determines that the irregular treatment condition supports an improved clinical outcome, the system 700 may forward the search results to a designated operator for further consideration to include aspects of the irregular treatment condition as modifications to a particular treatment or to a particular configuration of the drug administration device 500.

[0146] If the system 700 determines that an irregular treatment condition is associated with a worse than expected clinical outcome, the system's generated suggestions may include actions to be taken. For example, if the system 700 determines that the patient's irregular treatment condition will result in a worse or negative clinical outcome, the system 700 may generate a notification to the patient and / or the patient's medical professional to inform each of them that an improved treatment or an improved configuration of the drug administration device 500 is available that may result in the expected or improved clinical outcome. For example, the notification may suggest changing the administration interval from once a day to twice a day. Additionally, the notification may include various means or affordances to facilitate a conversation between the patient and the patient's care provider regarding the irregular treatment condition and the resulting negative clinical outcome. The notification to the patient's medical professional may include details of the treatment originally prescribed and the corresponding configuration of the drug administration device 500 for the particular treatment. The notification to the patient's medical professional may also include the expected clinical outcome of the particular treatment originally prescribed.

[0147] All of the devices and systems disclosed herein may be designed to be disposed of after a single use, or they may be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly. Specifically, the device can be disassembled and any number of the particular parts or portions of the device can be selectively replaced or removed in any combination. Once particular parts have been cleaned and / or replaced, 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 of a device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0148] It may be preferred that the devices disclosed herein be sterilized prior to use. This can be done by a variety of methods known to those skilled in the art, such as beta or gamma radiation, ethylene oxide, steam, and liquid baths (e.g., cold immersion). Exemplary embodiments for sterilizing devices including internal circuitry are described in more detail in U.S. Patent Publication No. 2009 / 0202387, published Aug. 13, 2009, entitled "System And Method Of Sterilizing An Implantable Medical Device." It is preferred that the device be completely sealed when implanted. This can be done by a variety of methods known to those skilled in the art.

[0149] The present disclosure has been described, by way of example only, within the context of the overall disclosure provided herein, and 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 disclosure. It should be noted that the present invention includes the following aspects. [Aspect 1] 1. A drug delivery system comprising: 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 including a sensor configured to sense information regarding at least one of the drug administration device and the drug, the drug administration device including a communication interface configured to wirelessly transmit data indicative of the sensed information; a server including a communication interface configured to wirelessly receive the data transmitted by the communication interface of the medication administration device, the server comprising: Correlating the patient's use of the drug with a clinical outcome for the patient; and performing a cost analysis that includes comparing a clinical outcome of the patient with clinical outcomes of other patients who received a drug different from the drug delivered to the patient; comparing the side effects experienced by the patient to side effects experienced by other patients who received a different drug than the drug delivered to the patient; determining whether the medication has been delivered to the patient in compliance with a treatment plan for the patient; Identifying a malfunction in the administration of said medication; determining that additional data is required from the medication administration device and triggering a request for the additional data to be transmitted wirelessly from the communication interface of the server to the communication interface of the medication administration device; creating a predictive model of a clinical outcome for said patient; a processor configured to use the data in at least one of the following: [Aspect 2] The system of aspect 1, wherein the drug administration device is one of a syringe, an injector, an inhaler, a nasal spray device, and an infusion pump. [Aspect 3] The processor is configured to use the data in at least correlating the patient's use of the drug with a clinical outcome for the patient, the processor also calculating the correlation between the patient's use of the drug and the patient's clinical outcome by: identifying trends in patient outcomes among a plurality of patients including the patient who received the drug; and monitoring side effects of the drug for a plurality of patients, including the patient who received the drug. [Aspect 4] 2. The system of aspect 1, wherein the processor is configured to use the data at least in performing the cost analysis, and wherein the processor is also configured to identify a second drug that has a lower cost than the drug and is associated with substantially the same clinical outcome as the patient. [Aspect 5] The processor is configured to use the data in at least determining whether the medication has been delivered to the patient in compliance with a treatment plan for the patient, the processor also configuring the determination by: generating an alert to a physician indicative of said patient's compliance; determining a trend in compliance of said patient; determining a trend of treatment regimen compliance in a specific population group including the patient and a plurality of additional patients, each patient in the specific population group sharing common attributes including at least one of age, ethnicity, and genetic profile; determining trends in treatment regimen compliance in a geographically specific population that includes the patient and a plurality of additional patients; The system of embodiment 1, configured for use in at least one of the following: [Aspect 6] The processor is configured to use the data in at least determining whether the medication has been delivered to the patient in compliance with a treatment plan for the patient, the processor also configuring the determination by: generating an alert to a physician indicative of said patient's compliance; determining a trend in compliance of said patient; determining trends in treatment regimen compliance in a geographically specific population that includes the patient and a plurality of additional patients; The system of embodiment 1, configured for use in at least one of the following: [Aspect 7] The system of aspect 1, wherein the processor is configured to use the data in identifying at least a malfunction in the administration of the medication, the malfunction including an inability of the medication administration device to administer the medication to the patient, and the processor is also configured to trigger an action for the patient to receive a new medication administration device. [Aspect 8] The system of aspect 1, wherein the processor is configured to use the data at least in identifying a malfunction in the administration of the medication, the malfunction including a user error in medication delivery, and the processor is also configured to trigger an alert indicating the identified malfunction. [Aspect 9] The system of aspect 1, wherein the processor is configured to use the data in identifying at least a malfunction in the administration of the drug, the malfunction including an irregularity in the administration of the dose that is at least partially delivered to the patient, and the processor is also configured to correlate the irregularity with a clinical outcome of the patient to determine whether the clinical outcome of the patient is better than the clinical outcome of other patients who have received the drug. [Aspect 10] The system of aspect 1, wherein the processor is configured to at least determine that additional data is needed from the drug administration device and use the data in 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, the additional data including at least one of the model number of the drug administration device when the drug was administered, the lot number of the drug administration device, the size of the dose size, the type of drug, and the viscosity of the drug. [Aspect 11] 2. The system of claim 1, wherein the processor is configured to use the data at least in creating a predictive model of a clinical outcome for the patient, and wherein the processor is also configured to use physician-inputted data regarding the patient in performing the predictive modeling. [Aspect 12] The system of aspect 1, further comprising a plurality of additional drug administration devices, each configured to deliver at least one dose of a drug to a different patient, each of the additional drug administration devices including a sensor configured to sense information regarding at least one of the drug administration device and the drug, and each of the additional drug administration devices including a communications interface configured to wirelessly transmit data indicative of the sensed information to the server. [Aspect 13] 2. The system of aspect 1, wherein the drug comprises at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate. [Aspect 14] 1. A drug delivery system comprising: a server including a communications interface configured to wirelessly receive data transmitted by the communications interface of each of a plurality of drug administration devices, each of the plurality of drug administration devices configured to administer a same drug to a different one of a plurality of patients, the server comprising: Correlating the patient's use of the drug with a clinical outcome for the patient; and performing a cost analysis that includes comparing a clinical outcome of the patient with clinical outcomes of other patients who received a drug different from the drug delivered to the patient; comparing the side effects experienced by the patient to side effects experienced by other patients who received a different drug than the drug delivered to the patient; determining whether the drug has been delivered to the patient in accordance with an individualized treatment plan for the patient; identifying a malfunction in any of said administrations of said medication; determining that additional data is required from any of the medication administration devices and triggering a request for the additional data to be transmitted wirelessly from the communication interface of the server; creating a predictive model of a clinical outcome for said patient; a processor configured to use the data in at least one of: [Aspect 15] The system of embodiment 14, wherein each of the drug administration devices is selected from the group consisting of a syringe, an injector, an inhaler, a nasal spray device, and an infusion pump. [Aspect 16] The processor is configured to use the data in correlating the patient's use of the drug with a clinical outcome for the patient, the processor also comprising: identifying trends in patient outcomes among said plurality of patients; monitoring the plurality of patients for side effects of the drug; and 15. The system of claim 14, wherein the system is configured to perform at least one of the following: [Aspect 17] 15. The system of claim 14, wherein the processor is configured to use the data at least in performing the cost analysis, and wherein the processor is also configured to identify a second drug that has a lower cost than the drug and is associated with substantially the same clinical outcome as the patient. [Aspect 18] The processor is configured to use the data in determining at least whether the medication has been delivered to the patient in compliance with an individualized treatment plan for the patient, the processor also configuring the determination by: generating an alert to a physician indicative of at least one of the patient's compliance; determining a trend in compliance of said patient; 15. The system of claim 14, wherein the system is configured for use in at least one of the following: [Aspect 19] The system of aspect 14, wherein the processor is configured to use the data in identifying at least a malfunction in any of the administration of the medication, the malfunction including an inability to administer the medication, and the processor is also configured to trigger an action for each of the patients associated with a malfunctioning medication administration device to receive a new medication administration device. [Aspect 20] The system of aspect 14, wherein the processor is configured to use the data in identifying at least any malfunction in the administration of the drug, the malfunction including a user error in drug delivery, and the processor is also configured to trigger an alert indicating the identified malfunction. [Aspect 21] The system of aspect 14, wherein the processor is configured to use the data in identifying at least a malfunction in any of the administrations of the drug, the malfunction including an irregularity in any of the at least partially delivered administrations, and the processor is also configured to correlate the irregularity with a clinical outcome of the patient to determine whether the clinical outcome of the patient is better than the clinical outcome of other patients who received the drug. [Aspect 22] The system of aspect 14, wherein the processor is configured to determine that additional data is needed from at least one of the drug administration devices and to use the data in triggering a request for the additional data to be transmitted wirelessly from the communication interface of the server, the additional data including at least one of the model number of the drug administration device when the drug was administered, the lot number of the drug administration device, the size of the dose size, the type of the drug, and the viscosity of the drug. [Aspect 23] 15. The system of claim 14, wherein the processor is configured to use the data at least in creating a predictive model of a clinical outcome for the patient, and the processor is also configured to use physician-inputted data regarding the patient in performing the predictive modeling. [Aspect 24] 15. The system of embodiment 14, wherein the drug comprises at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate. [Aspect 25] A method of drug administration comprising: sensing information about at least one of the medication administration device and the medication with a sensor of the medication administration device; wirelessly transmitting data indicative of the sensed information to a server using a communication interface of the medication administration device; A processor of the server processes the data. Correlating the patient's use of the drug with a clinical outcome for the patient; and performing a cost analysis that includes comparing a clinical outcome of the patient with clinical outcomes of other patients who received a drug different from the drug delivered to the patient; comparing the side effects experienced by the patient to side effects experienced by other patients who received a different drug than the drug delivered to the patient; determining whether the medication has been delivered to the patient in compliance with a treatment plan for the patient; identifying a malfunction in the administration of the medication; determining that additional data is required from the medication administration device and triggering a request for the additional data to be transmitted wirelessly from a communication interface of the server to the communication interface of the medication administration device; creating a predictive model of a clinical outcome for said patient; and using the same in at least one of the following: [Aspect 26] 26. The method of embodiment 25, wherein the drug comprises at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate.

Claims

1. 1. A drug delivery system comprising: a plurality of drug administration devices, each configured to deliver at least one dose of a drug to a corresponding different one of a plurality of patients, each of the plurality of drug administration devices including 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 including a communication interface configured to wirelessly transmit data indicative of the sensed information; A drug administration system comprising: a server including a communications interface configured to wirelessly receive the data transmitted by the communications interface of the drug administration device, the server including a processor configured to predictively model clinical outcomes of the plurality of patients, the drug administration system further configured to determine that a treatment plan for a first patient of the plurality of patients should be modified based on data received from at least one of the other patients of the plurality of patients.

2. The processor is configured to use the data in determining whether the drug has been delivered to the first patient of the plurality of patients in accordance with a treatment plan for the first patient, the processor also comprising: generating an alert to a physician indicating compliance of the first patient; determining a compliance trend for the first patient; determining a trend of treatment regimen compliance in a specific population group including the first patient and a plurality of additional patients, each patient in the specific population group sharing common attributes including at least one of age, ethnicity, and genetic profile; determining trends in treatment regimen compliance in a geographically specific population including the first patient and a plurality of additional patients; The system of claim 1 , configured for use in at least one of:

3. The drug delivery system of claim 1 , wherein each of the plurality of drug delivery devices is configured to deliver the same drug to a corresponding different one of the plurality of patients.

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

5. The processor is configured to use the data in correlating the first patient's use of the drug with a clinical outcome of the first patient, the processor also comprising: identifying trends in patient outcomes among said plurality of patients; monitoring the plurality of patients for side effects of the drug; and The system of claim 1 or 3, configured to perform at least one of the following:

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

7. The processor is configured to use the data in determining whether the drug has been delivered to the first patient in accordance with an individualized treatment plan for the first patient, the processor also configuring the determination to: generating an alert to a physician indicating at least one of the first patient's compliance; determining a compliance trend for the first patient; 4. The system of claim 1 or 3, adapted for use in at least one of:

8. 4. The system of claim 3, wherein the processor is configured to use the data in identifying at least a malfunction in any of the administration of the medication, the malfunction including an inability to administer the medication, and the processor is also configured to trigger an action for a patient associated with a malfunctioning medication administration device to receive a new medication administration device.

9. 4. The system of claim 3, wherein the processor is configured to use the data in identifying at least a malfunction in any of the administration of the medication, the malfunction including a user error in medication delivery, and the processor is also configured to trigger an alert indicating the identified malfunction.

10. 4. The system of claim 3, wherein the processor is configured to use the data in identifying at least a malfunction in any of the administrations of the medication, the malfunction including an irregularity in any of the at least partially delivered administrations, and the processor is also configured to correlate the irregularity with a clinical outcome of the first patient to determine whether the clinical outcome of the first patient is better than clinical outcomes of other patients of the plurality of patients who received the medication.

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

12. 4. The system of claim 1 or 3, wherein the processor is configured to use the data in creating at least a predictive model of a clinical outcome for the first patient, and the processor is also configured to use physician-inputted data regarding the first patient in performing the predictive modeling.

13. A method of drug administration comprising: sensing information regarding at least one of the drug administration device and a drug with a sensor of each of a plurality of drug administration devices, each of the plurality of drug administration devices being configured to deliver at least one dose of the drug to a corresponding different one of a plurality of patients; wirelessly transmitting data indicative of the sensed information to a server using a communication interface of each of the plurality of medication administration devices; a processor of the server predictively modeling a clinical outcome of a first patient of the plurality of patients; determining that a treatment plan for the first patient should be modified based on data received from at least one other patient of the plurality of patients; A method comprising:

14. 4. 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.

15. The method of claim 13, 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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