Method and apparatus for determining dosage of a device - Patents.com

Abstract

To provide computerized methods and apparatus for determining a dose injected into a user by one or more medication delivery devices.SOLUTION: Data is accessed that is indicative of an injection event group that includes one or more injection events associated with one or more medication delivery devices. The injection event group is processed to determine the dose injected into the user based on one or more of whether the injection event is associated with a medication delivery device change, a dose size of one or more of the injection events, a position of one or more of the injection events in the injection event group, and / or a time period between one or more injection events to a next injection event in the injection event group.SELECTED DRAWING: Figure 4A

Description

[Background technology]

[0001] Drug delivery devices include injection-type delivery devices that inject a dose of a drug. Injection devices often include a reservoir that holds the medication and a user-input device that determines the dosage needed for each injection. It contains a dose setting mechanism that allows you to set the size. Insulin pens are multi-purpose injections. An insulin pen is an example of a device that allows multiple doses over an extended period of time, such as days or weeks. Contains a reservoir of insulin sufficient for a single dose. With an insulin pen, the user is able to You can also specifically dial in the amount of units you want to deliver in one shot.

[0002] Patients who use drug delivery devices such as insulin pens should take care of their overall number of injections each day, as well as A prescribed dosing schedule, which may include the dosage and dose size for each injection, must be followed. Patients must manually track each injection and dosage size, which is tedious and tedious. This can be prone to human error. Summary of the Invention

[0003] The present disclosure relates to techniques for determining injection dose information. The technique handles multiple injection events and separates non-events (e.g., priming events (p It is possible to distinguish between the actual injected dose and the actual priming events. In some embodiments, the technique considers change events to determine the injected dose. , change information (e.g., change of drug cartridge and / or switching of drug delivery device) ) can be incorporated into the analysis.

[0004] Various aspects are described in this disclosure, including but not limited to the following aspects.

[0005] 1. A computer for determining the dose injected into a user by one or more drug delivery devices. A computerized method, the method being associated with one or more drug delivery devices. accessing data indicative of an injection event group that includes one or more injection events; Thus, each of the one or more drug delivery devices may be configured to allow a user to input a dosage for injection into the drug delivery device. Dose adjustment mechanisms that allow for adjustment and holding of medication for multiple dosing and one or more sensors for detecting the amount of medication dispensed per injection. and a wireless communication unit for communicating the amount of medication dispensed and the time it was dispensed. and wherein the access and injection event group is associated with a change in the drug delivery device. and whether the injection event group is related to a change in the drug delivery device. Once determined, analyzing the injection event group based on the first dose detection algorithm; Determining the dose administered to the user and determining whether the injection event group changes the drug delivery device Upon determining that the injection event group is associated with the second dose detection algorithm, and analyzing the dose administered to the user. Law.

[0006] 2. The one or more drug delivery devices include a previous drug delivery device and a new drug delivery device; Determining whether an injection event group is associated with a change in a drug delivery device is useful for the user. The user is considered to have had no prior drug delivery device use within a given time window of the injection event group. determining whether the patient has switched to using a new drug delivery device; Computerized methods.

[0007] 3. The one or more drug delivery devices include one drug delivery device, and the injection event group is Determining whether a change in the drug delivery device is associated with a predetermined injection event group. Is there a change in the replaceable drug cartridge of one drug delivery device within the time window of 2. The computerized method of embodiment 1, comprising determining whether

[0008] 4. Analyzing the injection event group based on the first dose detection algorithm; Determining that the number of injection events in the injection event group is greater than 2 and determining that the dose is an injection It is determined to be equal to the injected amount associated with the most recent injection event in the event group. determining whether the latest injection event is greater than or equal to any other injection event in the injection event group; and determining that the marker occurs later in time than the marker. A computerized method.

[0009] 5. The most recent injection event is designated as the true injection event, and the other injection event groups are 5. The method of claim 4, wherein every injection event is designated as a priming injection event. Computerized methods.

[0010] 6. Analyzing the injection event group based on the first dose detection algorithm, determining that the number of injection events in the injection event group is equal to 2; The event group includes a first injection event associated with a first time and a first injection event associated with a first time. a second injection event associated with a later second time. and a first injection amount associated with the first injection event is a second injection amount associated with the second injection event. and determining whether the second injection amount is greater than the second injection amount associated with the first injection amount. The computerized method described herein.

[0011] 7. If it is determined that the first injection event is greater than the second injection event, the first injection and determining the dose based on the sum of the first injection amount and the second injection amount. A computerized method of.

[0012] 8. If it is determined that the first injection event is not greater than the second injection event, the dose is The computerized method of claim 6, further comprising determining that the second injection volume is equal to the first injection volume. How it was done.

[0013] 9. The method of claim 8, wherein the first injection event is designated as a priming injection event. Computerized methods.

[0014] 10. Analyze injection event groups based on a second dose detection algorithm. ,(i) ,the ,change ,time ,associated ,with ,the ,change ,time ,of ,the ,drug ,delivery ,device ,change ,time ,for ,each ,of ,the ,injection ,event ,groups; (ii) later or earlier than the respective time associated with the injection event; Later than the time associated with at least one injection event in the injection event group and associated with at least one other injection event in the injection event group. 2. The computerized method of claim 1, further comprising: determining whether the time is earlier than another time that the computerized method of claim 1 has determined. The way it was done.

[0015] 11. Each time the change time is associated with each injection event in the injection event group If the dose is determined to be later or earlier than the most recent injection event in the injection event group, determining that the injected amount associated with the most recent injection event is equal to the injected amount associated with the most recent injection event; The injection event occurred later in time than any other injection event in the injection event group. 11. The computerized method of embodiment 10, further comprising:

[0016] 12. The method according to claim 11, wherein the remaining injection events are designated as priming injection events. The computerized method described above.

[0017] 13. The modification time is associated with at least one injection event in the injection event group. at least one other injection event in the injection event group occurs later than the time specified in is determined to be earlier than another time associated with the The first sub-injection event includes each injection event in the injection event group associated with The injection event group and the injection event group associated with the time that occurred after the change time. a second sub-group of injection events including each injection event of the group; 12. The computerized method of embodiment 10 or 11.

[0018] 14. Determining a dose, the first most recent of a first sub-injection event group. An injection event, wherein a first latest injection event is a first sub-injection event group. The first and most recent injection event, which occurred later in time than any other injection event in , a second latest injection event of the second sub-injection event group, The injection event occurs more quickly than any other injection event in the second sub-injection event group. and a second most recent injection event occurring later than the first injection event, 14. The computerized method of embodiment 13, further comprising:

[0019] 15. The remaining injection events of the first sub-injection event group and the second sub-injection event The remaining injection events of the vent group are designated as priming injection events. 14. The method according to claim 14.

[0020] 16. The method of embodiment 1, further comprising determining an injection event group.

[0021] 17. Determining the injection event group comprises determining whether a plurality of injection events meet a predetermined criterion. determining whether a plurality of injection events meet a predetermined criterion; For each injection event of the multiple injection events, The time between injections is within a predefined time period of the previous injection event in a multiple injection event. 17. The method of embodiment 16, comprising determining:

[0022] 18. A non-transitory computer-readable medium containing instructions, the instructions comprising: When executed by one or more processors of a processing device, the processing device 17. A non-transitory computer operable to perform the method according to any one of claims 1 to 17. Computer readable media.

[0023] 19. A memory for storing instructions and for carrying out the method according to any one of aspects 1 to 17. and a processor configured to execute instructions for:

[0024] 20. A device for determining the dose injected into a user by one or more drug delivery devices A computerized method, the method being associated with one or more drug delivery devices. By accessing data indicating an injection event group that contains one or more injection events. wherein each of the one or more injection events occurs within a predetermined time period and includes one or more drug delivery events. Each of the devices allows a user to adjust the dosage for injection of the drug delivery device. A dose adjustment mechanism and a reservoir large enough to hold the drug for multiple doses. a dispensed injection device for dispensing the medication from the injection; and a wireless communication unit for communicating the amount of drug and the time it was dispensed. and determining a dose administered to a user, the determining including an injection event. The group will receive a first injection event and a second injection event that occurs after the first injection event. determining whether the injection event group includes a first injection event and and a second injection event, the first injection event is determined to include the first injection event. The dose administered to the user or the duration of the user's first and second injection events is calculated based on the duration between the first and second injection events. and determining whether the priming dose not administered to the subject is related to the priming dose not administered to the subject. and determining.

[0025] 21. The computerized method of aspect 20, wherein the predetermined period of time is between 4 and 6 minutes.

[0026] 22. Determining the dose administered to the user is an injection event in the injection event group. The system will report the dose administered or the dose to the user based on the dose size of the injection event. 21. The method of claim 20, further comprising determining whether the missed priming dose is associated with a missed priming dose. The computerized method described above.

[0027] 23. Determining whether the dose size is greater than a first predetermined threshold; Upon determining that the size is greater than a first predetermined threshold, an injection event is administered to the user. determining that the dose size is not greater than a first predetermined threshold; If it is determined that the injection event is a group of injection events, the next injection event occurs after the injection event of the injection event group. and determining the dose administered to the user based on whether 2. The computerized method according to claim 2.

[0028] 24. The method of claim 23, wherein the first predetermined threshold is a dosage size of 9 to 11 units. A computerized method.

[0029] 25. If it is determined that the dose size is not greater than the first predetermined threshold, the injection event group determining whether a next injection event occurs after the injection event of the injection group; If it is determined that there is no next injection event in the event group, the injection event is injected to the user. determining that the next injection event in the injection event group is associated with the administered dose; If it is determined that there is an injection event, the period between the injection event and the next injection event in the injection event group is determined. and determining a dose administered to the user based on the time. The computerized method described above.

[0030] 26. Dosing a user based on the duration between a first injection event and a second injection event determining whether the administered dose is less than a second predetermined threshold. and determining that the duration is less than a second predetermined threshold, the first injection event is notified to the user. determining that the period is associated with a priming dose that was not administered in a second predetermined period; If it is determined that the threshold is not met, then administer the dose to the user based on the dose size of the first injection event. and determining the administered dose.

[0031] 27. The computer of embodiment 26, wherein the second predetermined threshold is a period of 75 to 85 seconds. Data-based method.

[0032] 28. Determine the dose administered to the user based on the dose size of the first injection event determining whether the dose size is greater than a third predetermined threshold; When the size of the injection is determined to be greater than a third predetermined threshold, a first injection event is determined to be an injection to the user. determining that the dose size is related to the administered dose and that the dose size is greater than or equal to a third predetermined threshold; If it is determined that the first injection event is not greater than and determining that the timing dose is associated with the computerized method of claim 26. The method used.

[0033] 29. The method of claim 28, wherein the third predetermined threshold is a dosage size of 4 to 5 units. Computerized methods.

[0034] 30. A non-transitory computer-readable medium containing instructions, the instructions comprising: When executed by one or more processors of a processing device, the processing device A non-transitory computer operable to perform the method according to any one of claims 20 to 29. A computer readable medium.

[0035] 31. A memory for storing instructions and a method for carrying out the method according to any one of aspects 20 to 29. and a processor configured to execute instructions to: [Brief description of the drawings]

[0036] Further embodiments of the present disclosure, as well as features and advantages thereof, will now be described in conjunction with the accompanying drawings. This will become more apparent by referring to the detailed description. Additionally, in the drawings, like reference numbers correspond throughout the different views. This shows the part that is

[0037] [Figure 1] 1A-1D show illustrative examples of drug delivery devices, according to some examples. [Diagram 2] 1 is a flowchart illustrating an example computerized process for determining injection event groups, according to some embodiments. [Figure 3A] 1 is a table showing examples of injection event groups, according to some embodiments. [Figure 3B] 1 is a table showing examples of injection event groups, according to some embodiments. [Figure 4A] 1 is a flowchart illustrating an example computerized process for determining a dose based on injection event groups, according to some embodiments. [Figure 4B] 1 is a flowchart illustrating an example computerized process for determining a dose based on injection event groups, according to some embodiments. [Figure 5A] 13 is a table showing an example of dose determination for an injection event group not related to a change in drug delivery device, according to some embodiments. [Figure 5B] 13 is a table showing an example of dose determination for an injection event group not related to a change in drug delivery device, according to some embodiments. [Figure 5C] 13 is a table showing an example of dose determination for an injection event group not related to a change in drug delivery device, according to some embodiments. [Figure 6A] 1 is a table showing an example of dose determination of an injection event group associated with a change in a drug delivery device, according to some embodiments. [Figure 6B] 1 is a table showing an example of dose determination of an injection event group associated with a change in a drug delivery device, according to some embodiments. [Figure 7] 1 is a flowchart illustrating an example computerized process for determining a dose based on an injection event group that includes one or more injection events occurring within a predetermined time period, according to some embodiments. [Figure 8A] 1 is a table showing an example of dose determination for an exemplary injection event group where the injection events occur within a predetermined time period of 5 minutes, according to some embodiments. [Figure 8B] 1 is a table showing an example of dose determination for an exemplary injection event group where the injection events occur within a predetermined time period of 5 minutes, according to some embodiments. [Figure 8C] 1 is a table showing an example of dose determination for an exemplary injection event group where the injection events occur within a predetermined time period of 5 minutes, according to some embodiments. [Figure 8D] 1 is a table showing an example of dose determination for an exemplary injection event group where the injection events occur within a predetermined time period of 5 minutes, according to some embodiments. [Figure 8E] 1 is a table showing an example of dose determination for an exemplary injection event group where the injection events occur within a predetermined time period of 5 minutes, according to some embodiments. [Figure 9] 1 is a flowchart illustrating an example computerized process for determining a dose based on injection event groups, according to some embodiments. [Figure 10A] 1 is a table showing an example of dose determination for an exemplary injection event group, according to some embodiments. [Figure 10B]1 is a table showing an example of dose determination for an exemplary injection event group, according to some embodiments. [Figure 10C] 1 is a table showing an example of dose determination for an exemplary injection event group, according to some embodiments. [Figure 11] FIG. 1 illustrates an example system for implementing the computerized processes described herein, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, in which: Certain language will be used to describe this, however it is understood that this does not limit the scope of the invention. It will be understood that it is not intended to

[0039] The present disclosure relates to techniques for accurately determining dose injection information. The drug delivery device can be either disposable or reusable. Once the insulin runs out, the disposable pen is discarded and replaced in its entirety. A pen has a port that accepts an insulin cartridge. Once this is done, the user can discard the old cartridge and insert a new one. For example, MEDICATION INJECTOR AP, published on March 27, 2007 PARATUS WITH DRIVE ASSEMBLY THAT FACILIT No. 7,393,633, entitled "ATES RESET," which is incorporated herein by reference in its entirety. No. 195,616 describes an example of a reusable insulin pen.

[0040] Insulin pens usually need to be primed periodically before use. Infusion typically involves the user intentionally expelling a small amount of insulin (e.g., into the air) to Excess insulin in the needle or anywhere else in the fluid pathway between the insulin reservoir of the pen and the needle tip This involves removing the air. If the pen is not properly primed before use, Air in the needle and / or fluid path may cause the pen to deliver less insulin than requested. Possibly an injection.

[0041] Manual tracking of injections and doses by users is tedious and error-prone, making it difficult to track drug The delivery device wirelessly transmits injection event information, including time and dose size of insulin injection. Include wireless capabilities that can be reported (e.g., WiFi, Bluetooth, NFC, etc.) As used herein, an "injection event" refers to an injection that is delivered at a particular time. Injection event information can be sent to a smartphone ( For example, running a mobile application) or on a remote device such as a cloud server. The true injected dose of insulin injected into the patient's body and the dose not injected into the patient can be transmitted. It is necessary to distinguish between the actual dose and the priming dose. When a user injects a bot, the remote device and / or cloud server may receive more data than the user actually injected. The patient may mistakenly determine that too much insulin has been injected. ,Next, the validity of the user's insulin dose log, and the amount of insulin stored ( For example, it may affect the calculation of the amount of unused active insulin circulating in the user's body. Incorrect built-in insulin calculations can affect the validity of subsequent bolus calculations. There is a possibility that it will have an impact.

[0042] Also, users may distribute a single dose to more than one pen (e.g., disposable insulin pens). Splitting doses or replacing reusable insulin pen cartridges mid-dose The fractionated doses also need to be specified.

[0043] The following example shows that both the priming dose and the split dose must be detected: The user needs to take 15 units of insulin but only has 7 units left in the pen. The user presses the pen to release two small doses into the air. The user then injects the remaining 5 units. The user then removes the empty pen. Discard it and choose a new pen (or, if the pen is a reusable pen, replace the used (Replace the insulin cartridge). The user must be aware that there is no air left in the needle. Fill the new pen (or Prime the new pen or cartridge. Once properly primed, the user injects the remaining 10 units.

[0044] The device receiving the injection event data in this example would receive the following series of injection doses: 2, 5, 2, 2, Data is received indicating 2 and 10 units of insulin. The device detects that all of these doses If assumed to be an actual dose, it may overestimate the amount of insulin the user actually took. (For example, a user may inject 23 units of insulin when in fact they only injected 15 units. Therefore, the actual dose and priming dose actually injected into the patient are Distinguish between single doses and single doses and identify when a dose has been split into two separate pens or cartridges It is necessary to.

[0045] The technology described herein allows for accurate determination of the dose injected into a patient by a drug delivery device. Computer-implemented technologies that provide Provides computer applications, including web-based applications. In some embodiments, the technique may include, for example, based on injection event times (e.g., 5 minutes apart from each other). Grouping of injection events (by grouping injection events that occur within minutes) Such an injection event group can be configured to determine the injection event group. In some embodiments, the technique may include any group of injection events. Process injection event groups depending on whether the event group is related to a device change The device may be configured to allow a user to switch to a new disposable drug delivery device (e.g., (e.g., by replacing the drug cartridge in a reusable drug delivery device). If the projectile event group is not associated with an equipment change, the technique A first injection event group configured to determine dosage information for the unlinked injection event group. An injection event group can be processed according to an algorithm. If the group is related to a device change, the technique and determining dose information for the injection event group using a second algorithm configured to determine dose information for the injection event group. Groups can be processed.

[0046] In some embodiments, the technique determines groups of injection events that occur within a period of time. The injection event may be configured to determine the time to which the injection occurs (e.g., injection events occurring within a 5 minute period). In some embodiments, the dose administered to the user is determined by the number of injection events administered to the user. Determine whether this is related to the dose given or the priming dose not given to the user. This determination may be made by determining whether the injection event group is a first injection event. Determine whether the injection event includes a second injection event that occurs after the first injection event The injection event group may include a first injection event and a second injection event. If it is determined that the injection event is included, the determination is made by determining whether the first injection event and the second injection event are included. The method may further be based on the period between.

[0047] While various embodiments have been described, it is understood that many more embodiments and implementations are possible. It will be apparent to one skilled in the art that the embodiments described herein are illustrative and not restrictive. In addition, the advantages described above are not necessarily the only advantages. It is not necessarily expected that all of the described advantages will be achieved in each embodiment.

[0048] FIG. 1 is an illustrative example of a drug delivery device 20, according to some examples. The 0 is a reusable drug injection pen. It is the most commonly known reusable device of its type. As shown, the injection pen 20 is attached to a reusable pen base generally designated 26. As part of a cartridge assembly generally designated 24, which is connected to a drug loading cartridge The cartridge or reservoir 22 contains a ridge or reservoir 22 for storing multiple doses of medication. The pen base 26 is preferably of a size sufficient to hold a quantity of medication. 2 and then administering the drug via needle assembly 27, which is shown attached thereto. A dose setting and discharging mechanism that functions to allow the cartridge assembly 24 to be ejected As shown, the pen base 26 includes a rotatable, An exposure knob 28 with a button 30 that can be used to expose the pen is otherwise housed within the pen base 26. It is the manually operable part of the dose setting and injection mechanism. The knob 28 is designed to be rotatable to set the dose. When rotated to increase the selected dose, the knob 28 and button 30 are 1. From an axial position in the pen base 26, or translated to the right from the viewer's perspective in FIG. During the dose injection process, which occurs after the dose setting process, the knob 28 is free to When a plunge force is applied to the rotating button 30, the button 30 and knob 28 shift to the left. The pen is housed within a pen base and is designed to be lifted and returned to the axial position as shown in Figure 1. The injected injection mechanism components are then actuated to inject the medication within the cartridge.

[0049] In some embodiments, the drug delivery device detects the dose dispensed for each injection. For example, the drug delivery device may include one or more sensors used to One or more sensors configured to detect movement and / or alteration of components of the delivery device. Examples of such sensors include magnetic field sensors, switches, and accelerometers. , gyroscopes, etc. As another example, the drug delivery device may include a dose setting member. The present invention relates to a method and apparatus for controlling a semiconductor device, the method comprising: No. 7,195,616, issued to the assignee of the present invention, provides some non-limiting examples of such sensors. Contains:

[0050] In some embodiments, the drug delivery device may be configured to automatically detect when a user changes the drug cartridge. One or more that are used to detect (e.g., when a user changes the reservoir 22) For example, the drug delivery device may include a cartridge for the drug delivery device. One or more switches and / or pressure switches for detecting the removal and / or insertion of A sensor may be included.

[0051] In some embodiments, the drug delivery device comprises a central processing unit (CPU), a microcontroller, Processing units such as microcontroller units (MCUs), application specific integrated circuits (ASICs), etc. In some embodiments, the processing unit may include a processing unit (or multiple units). The system uses the data generated from the sensor to determine the dosage and / or cartridge of the injection. In some embodiments, the processing unit may be configured to determine the insertion / removal of a processing unit. The device is configured to perform the techniques described herein, including determining the dose of an injection. It is possible.

[0052] In some embodiments, the drug delivery device may include a communication unit. The unit is connected to a wired communication unit (e.g., Universal Serial Bus (USB), Fire Wire, Serial, etc.) and / or wireless communication units (e.g., Bluetooth oth, WiFi, Near Field Communication (NFC), etc.) For example, a communication unit WiFi transceiver, Bluetooth transceiver, RFID transceiver, USB transceiver, Near Field Communication (NFC) transceiver, combination chip The processing unit may use the communication unit to receive injection event information (e.g. , the dose dispensed and the time dispensed), cartridge change information, and / or may be configured to transmit other information to another device.

[0053] FIG. 2 is an exemplary diagram for determining injection event groups according to some embodiments. 2 is a flow chart illustrating a computerized process 200. For example, it can be performed by a drug delivery device, a smartphone, a server, etc. In step 202, the device accesses data indicative of an injection event. For example, the device may Report a set of injection events from a drug delivery device at substantially the same time (e.g., in a batch report) or the device can receive a drug delivery signal when each injection event occurs. Each injection event can be received separately from the device.

[0054] In step 204, the device inserts the received injection event into a currently open injection event group. If there is no injection event group currently open, the device adds a new one to the current Create an injection event group that contains the injection event.

[0055] In step 206, the device starts an injection event window. C adds the newly received injection event to the currently open injection event group. In some embodiments, the period during which an injection event window is initiated may include a period during which an injection event window is initiated. may include starting a timer.

[0056] In step 208, the device may, for example, determine whether an injection event window has expired before a timer expires. If so, the device determines whether it has accessed data indicating a new injection event in the The procedure proceeds to step 204 (adding a new injection event to the currently open injection group). , step 206 (reopening the injection event window), and step 208 (new Access the data showing new injection events in the resumed injection events window. If a new injection event is received in the injection event window, If not, the device proceeds to step 210 and closes the injection event group. If an additional new injection event is received within the opened injection event window, the device The device then returns to step 204. In this manner, the device continues to Steps 204, 206, and 207 are repeated until no new injection events are received in the window. Repeat step 208.

[0057] In operation, for example, the device may deliver each injection within (e.g., less than) 5 minutes of the previous injection. In this example, the duration of the injection event window is 5 minutes, but one or more injections Shooting events can be grouped into a single shooting event group. Thus, For example, injection event data may show that the pen administered a second injection 4 minutes after the first injection, If the device indicates that a third injection was administered 3 minutes after the second injection, the device will Group all into the same injection event group (e.g., the first injection event and (although the elapsed time between the third injection event is 7 min).

[0058] Process 200 may be modified in a variety of ways. For example, in some embodiments, may not restart the injection event window every time a new injection event is received. In such an embodiment, all injection events are in the same injection event group. To be grouped, they must be received within a certain time period of the first injection event. In some embodiments, the device may display the currently open injection event in the injection event group. Optionally, the system checks whether an injection event meets certain predefined criteria before adding it to the group. For example, the device may determine that a particular minimum dosage size (e.g., one unit) is exceeded. injection events that are greater than a certain minimum duration, last longer than a certain maximum duration, or last You can configure the system to add only the currently open injection event to the injection event group. Injection events that do not meet the criteria will not be added to the currently open injection event group. There are cases.

[0059] 3A-3B are table 30 illustrating examples of injection event groups, according to some embodiments. 0, 350. As shown in table 300, one injection event 302 is a 2 unit dose. This occurred at 4:42:03 PM, with an additional injection event five minutes later at 4:47:03 PM. did not occur, so injection event 302 is the only injection event in the injection event group. In this example, injection event 302 is the only injection event in the injection event window. event, it is an injection event (as opposed to, for example, a priming event). As shown in table 350, the injection event group (in this example, the group Group 1) includes five different injection events 352-360. As shown, each injection The injection event is within 5 minutes of the previous injection event. For example, injection event 354 is , which occurred at 4:55:19 p.m., which is a continuation of the injection event that occurred at 4:55:14 p.m. It is within 5 minutes of T352.

[0060] FIG. 4A illustrates a method for determining dose based on injection event groups, according to some embodiments. 4 is a flowchart illustrating an exemplary computerized process 400 for In step 402, a device (e.g., a drug delivery device, a smartphone, a server, etc.) , accessing an injection event group that includes one or more injection events. As shown, an injection event group is associated with one or more drug delivery devices. It can include an injection event (eg, delivered).

[0061] In step 404, the device determines whether the injection event group is associated with a change in the drug delivery device. In some embodiments, the device modification comprises modifying one disposable drug delivery device. Switching from one device to another, disposable drug delivery device, and / or reusable drug delivery devices In some embodiments, the drug delivery device may include modifying the drug cartridge. The device is adapted to allow the disposable drug delivery device to use the drug in the reservoir when the cartridge is changed. When the new disposable drug delivery device is replaced by the previous disposable drug delivery device, In some embodiments, the device may store and / or report data indicating when a device is substituted for another device. In this case, the change in the device can be determined from other information. For example, if the user has changed When selecting a disposable drug delivery device, the user first aligns the drug delivery device with an attachable Modules, applications running on smartphones, servers, etc. The device may need to be paired with a new drug delivery device. When the device is ringed and / or paired with another device in the system, It can be determined that there has been a change in the location.

[0062] In some embodiments, the change time is within a predetermined time of the injection event group. For example, if the time window is determined based on the injection event group, For example, if a user is the first injection of a group, the group may be determined to be associated with a change in the device. During the period beginning 5 min prior to the event and ending at the time of the group's last injection event If you change the pen or replace the replaceable cartridge, the device will As another example, a user may determine that a group of users is associated with a change in device. , starting 5 min before the first injection event of the group and ending 5 min before the last injection event of the group. During the period that ends 5 minutes after the time, you can change the pen or replace the cartridge. When the injection event group is changed, the device determines that the injection event group is associated with the device change. can be done.

[0063] If an injection event group is not associated with the change, the method proceeds to step 406. 4. Proceed and determine the injection dose based on the first dose detection algorithm shown in steps 406 through 414. The event group is analyzed to determine the dose administered to the user. Injection Event Group In the case where modification of the drug delivery device is involved, the method is as shown in FIG. 4B, which is further described below. The method proceeds to analyze the injection event groups based on the second dose detection algorithm and The dose administered to the user is determined.

[0064] In step 406, the device determines whether there are three or more injection events in the injection event group. If there are three or more injection events, the method proceeds to step 408, The device determines whether the dose administered to the patient is the last injection event in the group (or any other injection event). The dose is determined to be equal to the dose associated with the injection event (which is an injection event that occurred after the injection event). The device may designate the remaining injection events as priming injection events. do.

[0065] If there are not three or more injection events, the method proceeds to step 410. Although not shown in the chart, if the injection event contains only one event, the system The step can be configured to determine that an injection event includes an injected dose. In step 410, if there are two injection events in the injection event group, the device The dose of the first injection event that occurred in time was used for the second injection event that occurred later in time. Determine whether the dose of the first injection event is greater than the dose of the second injection event. If so, the method proceeds to step 412 and determines the sum of the doses of both injection events. The dose is determined based on the dose of the first injection event being greater than the dose of the second injection event. If not, the method proceeds to step 414, where the device determines that the dose administered to the patient is greater than the second dose. The device determines that the first injection event is equal to the dose of the first injection event. It can be specified as an injection event.

[0066] In some embodiments, step 410 includes determining whether the dose of the first injection event is greater than the dose of the second injection event. Only if the dose is greater than the event dose by a predetermined threshold, the method proceeds to step 412. The dose of the first injection event may be modified so that the dose of the first injection event is greater than the dose of the second injection event by a predetermined amount. If the threshold is not greater than the predetermined threshold, the method may proceed to step 414. The dose may be an absolute number of units of the first injection (e.g., 7 units) or a ratio of the first injection dose to the second injection dose. The required minimum ratio of injection doses (e.g., 5:1 ratio of first injection dose to second injection dose) (must exceed 100 ms).

[0067] 5A-5C are tables 500, 530, and 560, respectively, and are examples of several implementations. Dose estimation for injection event groups not associated with changes in drug delivery device, by morphology Referring to table 500 in FIG. 5A, the injection event group includes two The injection events 502 and 504 are included. Since there are only two injection events, the device The doses of injections are compared. Injection 2 is a dose of 504 (33 units) compared to injection 1, 50 Since this is more than 2 (two unit) doses, the device will notify the user that the injected dose is 33 units. The first injection event is not counted toward the amount injected by the priming event. It is determined to be a vent.

[0068] Referring to table 530 of FIG. 5B, the injection event group includes three injection events 532. , 534, and 536. Since there are three injection events, the device Vent 536 is an injection event, and the other two injection events 532 and 534 are pla It is determined to be a timing event.

[0069] Referring to table 560 of FIG. 5C, the injection event group includes two injection events 562. and 564. Because there are only two injection events, the device compares the dosage of the two injections. The dose of the first injection event 562 (12 units) is compared to the dose of the second injection event 564 ( Because the dose is greater than 2 units, the device determines that each injection event is an injection and The amount injected is therefore equal to a combination of two doses, or 14 units.

[0070] FIG. 4B illustrates an injection event group associated with a change in a drug delivery device, according to some embodiments. 4 illustrates an exemplary computerized process 450 for determining a dose based on a loop. In step 452, the device selects an injection event from the injection event group. Determine if a change in the drug delivery device occurred during the vent. The change time is based on the injection event. If the injection event occurs before or after all of the injection events for the injection group, the device , and the last injection event (the event that occurs after the other injection events in the group) The injected dose and the remaining injection events are determined to be priming events. For example, as described herein, a change event may be an injection event in an injection event group. occurred within a specific time period after the last injection event (e.g., within 5 minutes of the time of the last injection event) In this case, the injection event group can be associated with the change event. As described herein, a change event is generated for all injection events in an injection event group. If an injection event occurs within 5 minutes before the injection, the injection event group can be associated with the change event. All injection events in the injection event group occur before or after the change. If so, the method proceeds to step 454 and determines whether the last injection event was the injected dose and whether the remaining The next injection event can be determined to be a priming event. For example, the method may proceed to step 456, as described below.

[0071] If the change time occurs between injection events, the device proceeds to step 456 and The first sub-injection event group includes the injection events that occurred before the change time. The second sub-injection event group contains each injection event of the injection event group that occurred. The group contains each injection event in the injection event group that occurred after the modification time. In step 458, the device determines the last injection event in each sub-injection event group. In particular, for the first sub-injection event group, The device will start the most recent injection event (after any other injection event in the first sub-injection event group). The first injection event (occurring in the first half of the day) is the injected dose, and the remaining injection events (if any) are the primary Similarly, for the second sub-injection event group, the device is the dose injected at the latest injection event and the remaining injection events (if any) The device determines that each sub-injection event group is a priming event. Determine the total injected dose by adding the dose of the last injection event in the loop It is possible.

[0072] 6A-6B show injection events associated with modification of a drug delivery device, according to some embodiments. 6A and 650 show examples of dose determinations for patient groups. Referring to FIG. 6, table 600 includes five injection events 602-610. column, the time of change (for example, the time when the user changed the cartridge and / or the time the user switched to a new pen) is 4:54:56 PM. The time is for all injection events 602 to 610 (4:55:14 p.m. to 4:55 p.m. Because the last injection event 610 occurred before the injection time (occurred within minutes and 34 seconds), the device represents the injected dose, and the remaining injection events represent the placebo events. It is determined to be a timing event.

[0073] Referring to table 650 of FIG. 6B, table 650 includes two injection events 652 and 654. As shown in the third column, the change time is 7:41:55 PM, which means The first injection event 652 at 7:39:31 p.m. and at 7:42:10 p.m. The second injection event 654 occurs between the first injection event 654 and the second injection event 654. Thus, the system In this example, each sub-injection event group has one The first sub-injection event group contains only injection events 652 and 653. , and the second injection event group includes injection event 654. The last (and only) injection event in the injection event group was the one that included the injected dose. Thus, the example injection amount shown in table 650 is 6 units.

[0074] In some embodiments, the dose administered to the patient is determined by the injection event group. Use other methods that do not require determining whether the change is associated with a device change. Such a method is advantageous in that no change information on the drug delivery device is available. Such methods may be used in cases where injection events within a particular time period (e.g., a particular minute) By using the injection event group, which contains injection events that occur within a few seconds of each other, Thus, the dose administered to the patient can be determined. Each of the doses represents a dose administered to the user or a priming dose not administered to the user. determining whether the dose administered to the user is associated with The determination may include determining whether the injection event group includes a first injection event and a first determining whether the injection event includes a second injection event occurring after the first injection event; If it is determined that the injection event group includes a first injection event and a second injection event, Once determined, the determination may be based on the duration between the first injection event and the second injection event. (e.g., ranking the duration against the duration of other sequential injection events and / or the duration The determination may also optionally include determining whether the medication support for the injection event is greater than a predetermined period. size (e.g., whether the dosage size is greater than the number of units) and injection event group the position of the injection event in the injection event group (e.g., the injection event remains in the injection event group) Whether it is the only injection event or whether there are further injection events) The method may be based on one or more of the following:

[0075] FIG. 7 illustrates one or more injection events occurring within a given time period, according to some embodiments. An exemplary computerized method for determining a dose based on an injection event group including: 7 is a flow chart illustrating a process 700 for detecting an injection event. Select an injection event from the injection event group. An injection event group contains one or more injection events. In some embodiments, the injection event group can include A set of one or more injection events occurring during a certain period of time. For example, an injection event group The loop includes 3 minutes, 5 minutes, 7 minutes, and 8 minutes from the first injection event in the injection event group. and / or any other injections occurring during that time period. The device may then substantially synchronously analyze the data associated with the multiple injection events of the injection event group. can be accessed at any time (e.g., the injection event in the injection event group) Batch download of pre-recorded data for some or all of the sets and In some embodiments, the device may be configured to monitor the time (e.g., at the time of each injection event). and / or immediately after each injection event occurs, separately receiving data indicative of each injection event. You can access one or more injection events of an injection event group separately, for example by Thus, step 702 selects an injection event from the plurality of injection events. and / or processing a single injection event (e.g., , upon receipt from the drug delivery device and / or upon the occurrence of an injection event).

[0076] In step 704, the device determines whether the dose size of the selected injection event is greater than or equal to a first predetermined threshold. For example, the predetermined thresholds are 6 units, 7 units, 9 units, 1 0 units, 11 units, etc. If the dosage size is greater than the threshold, the method continues with step Proceeding to 706, where the device determines whether the selected injection event corresponds to an injection dose administered to the user. If the dose size is not greater than the first predetermined threshold, the method proceeds to step Proceeding to step 708, the next note in the injection event group that occurs after the selected injection event is Determine whether there is an injection event. If there is no other injection event, the method returns to step 7. 06, where the device determines whether the selected injection event is related to the injection dose administered to the user. After step 706, the method proceeds to step 718, described below. If in step 708 the method determines that there is a next injection event, the method continues with step 7 Go to 10.

[0077] As described herein, an injection event in an injection event group is an injection event , which may be accessed as a set of pre-recorded data indicative of an injection event. receive and / or access the batches substantially simultaneously) and / or separately The injection event information may be received separately (e.g., at the time or shortly after each injection event). In some embodiments, if the injection event is accessed separately, step 708 includes: The device records the first injection event (e.g., the injection event selected in step 702). The event window (a predefined period, such as 3 minutes, 5 minutes, 7 minutes, or some other period) The device may include a device for determining whether to receive a next injection event within a certain period of time. In some embodiments, one or more injection events are accessed as a group of events. If so, step 708 analyzes the data for the group of events to determine the next injection event. The method can include determining whether there is a

[0078] In step 710, the device determines the time between the selected injection event and the next injection event. For example, the device may determine whether the next injection event is greater than a second predetermined threshold. determining whether an injection occurs more than a predetermined number of seconds after a selected injection event; (For example, 59.5 seconds, 60 seconds, 60.5 seconds, 79.5 seconds, 80 seconds, etc.) If the time between vents is not greater than the threshold, the method proceeds to step 712, where the device The selected injection event (i.e., the injection event selected in step 702) is After step 712, the method determines that the dose is associated with a priming dose that was not administered. proceed to step 718.

[0079] If the time between injection events is greater than the second predetermined threshold, the method proceeds to step 714. The device then determines whether the dose size of the selected injection event is greater than a third predetermined threshold. For example, the device may determine whether the dosage size is 3 units, 3.5 units, 4 units, or 4.5 units. It can be determined whether a dosage size exceeds a threshold, 5 units, 5.5 units, etc. If not, the method proceeds to step 712 where the device selects the injection injection If the vent is determined to be associated with a priming dose that has not been administered to the user, then the method If the dose size is greater than the third predetermined threshold, the method proceeds to step 718. Proceeding to 706, the device determines whether the selected injection event is associated with an injection dose administered to the user. Then it is determined.

[0080] Following steps 706 and 712, the method proceeds to step 718, in which the device Injection event groups that need to be classified as either volume or priming dose If there are no additional events, the method Proceed to step 720, where the device ends the dose detection process. Additional Injection Events If so, the method returns to step 702 and selects the next injection event in the injection event group. Select and repeat the process as described herein.

[0081] 8A-8E are tables 800, 820, 840, 860, and 880, respectively. Illustrative Example with Injection Events Occurring Within a Predefined Time Period of 5 Minutes, According to Some Embodiments These examples show the dosage determination of a first threshold medication size. The size was 10 units, the time between injection events for the second threshold was 79.5 seconds, and for the third threshold The dosage size is 4.5 units.

[0082] Referring to table 800 in FIG. 8A, the device selects the first injection event 802 and selects 11 units. is determined to be greater than a predetermined threshold of 10 units. The device determines that the first injection event 802 is associated with a dose administered to the user. Then, the device selects a second injection event 804, and the dosage size of each of the three units is 1 0 units. Thus, the device determines that the second injection event It is determined that there are no other injection events in the injection event group following the injection event 804, and the second injection It is determined that the event 804 is related to an injection dose administered to the user. The injection dose for the injection event group designated 00 is 14 units.

[0083] Referring to table 820 of FIG. 8B, the device selects the first injection event 824 and injects 3 units of The device determines that each dose size is not greater than a predetermined threshold of 10 units. If it is determined that there are no other injection events in the injection event group following the first injection event 824, and therefore determining that the first injection is associated with an injection dose administered to the user. Therefore, the injected dose for the injection event group shown in Table 820 is 3 units. .

[0084] Referring to table 840 of FIG. 8C, the device selects the first injection event 842 and injects 5 units. The device determines that each dose size is not greater than a predetermined threshold of 10 units. , determining that the second injection event 844 occurs after the first injection event 842; Additionally, the 60 second period between the first injection event 842 and the second injection event 844 The device therefore determines that the first injection event 8 is not longer than the threshold of 79.5 seconds. 42 is associated with a priming dose that has not been administered to the user. Since there is a second injection event 844 occurring after event 842, the device then performs an analysis The device selects the event for a dose size of 3 units above the 10 unit threshold. The injection event is not large and no other injection events occur within 5 minutes of the second injection event 844. Therefore, the second injection event 844 determines that the injection dose administered to the user Therefore, the injection doses for the injection event groups shown in Table 840 are 3 It is a unit.

[0085] Referring to table 860 of FIG. 8D, the device selects the first injection event 862 and injects 5 units. The device determines that each dose size is not greater than a predetermined threshold of 10 units. determining that a second injection event 864 occurs after the first injection event 862; and 81 seconds between the first injection event 862 and the second injection event 864. The device determines that the first injection event 86 of 5 units is longer than the threshold of 0.5 seconds. The device determines that the dosage size of 2 is greater than the predetermined threshold of 4.5 units. , it determines that the first injection event 862 is associated with an injection dose administered to the user. Then, the device selects a second injection event 864, with each of the three units having a dosage size of 10. After determining that the unit threshold is not greater than the second injection event 864, another injection event is not performed. Therefore, the device determines that the second injection event 864 is also not a user event. Therefore, the injection doses shown in Table 860 are related to the injection doses administered. The injected dose for the event group is 8 units.

[0086] Referring to table 880 of FIG. 8E, the device selects the first injection event 882 and injects 2 units of The device determines that each dose size is not greater than a predetermined threshold of 10 units. determining that a second injection event 884 occurs after the first injection event 882; and 81 seconds between the first injection event 882 and the second injection event 884. The device determines that the dose size of each of the two units is greater than the threshold of .5 seconds. The device therefore determines that the first injection event 8 is less than the threshold of 4.5 units. 82 is associated with a priming dose that has not been administered to the user. selects the second injection event 884, and the dose size of each of the three units exceeds the threshold of 10 units. After determining that the second injection event 884 is smaller than the value, the third injection event 885 is The device determines that there is a second injection event 884 and a third injection event 886. 886 is not longer than the threshold of 79.5 seconds. The device also detects that the second injection event 884 is not a priming injection that was administered to the user. Finally, the device selects the third injection event 886 and determines that the injection is associated with a 3 unit dose. After determining that each of the dose sizes is not greater than the 10 unit threshold, the third injection is administered. It is determined that no other injection events occur after vent 886. Therefore, the third note The injection event 886 is related to an injection dose administered to a user. The injection dose for the injection event group shown is 3 units.

[0087] One advantage of the process 700 for determining dosage is that it can be used to determine Another advantage of the process 700 is that it does not require any modification information of the drug delivery device. Any given injection event is administered to a user within 5 minutes of the occurrence of the given injection event. were classified as being related to an injected dose that was not administered to the user or a priming dose that was not administered to the user. The process 700 obtains all of the injection event groups before making a classification decision. There is no need for the user to wait until all injection events are known.

[0088] In some embodiments, the process 700 simplifies steps 710 and 714. For example, the process 700 may be modified by selecting If it is determined that the next injection event occurs within a certain period of time after the previous injection event (e.g., 3 Next injection event within minutes, 5 minutes, 7 minutes, or other predefined time period of the selected injection event ), the process 700 may proceed without going through steps 710 and / or 714. In such an embodiment, the injected dose may be automatically classified as a priming dose. , the process 700 waits a predetermined period of time after the selected injection event has elapsed, The selected injection event may be classified as an injection dose. If an injection event is received, the selected injection event is the injection dose for priming. may be reclassified into quantities.

[0089] This modified embodiment of process 700 is similar to that presented in FIGS. 8A-C and 8E. yielding the same priming vs. injection event classification but different from that presented in Figure 8D Specifically, referring to table 860 in FIG. In the illustrated embodiment, the device selects the first injection event 862 and dispenses five units each. The device then determines that the dosage size of the first A second injection event 864 occurs within 5 minutes (a predetermined period) of the injection event 862. Without further investigation into the time gap between injection events 862 and 864, Without further investigation into the dose size of the injection event 864, the device The device then classifies the injection event 862 as a priming dose for analysis. Select injection event 864. Any further injection events occur within 5 minutes of injection event 864. After determining that the injection has not been administered, the device records the injection event 864 as an injection dose administered to the user. Classify them as follows.

[0090] FIG. 9 illustrates determining a dose based on injection event groups, according to some embodiments. 9 is a flowchart illustrating another example computerized process 900 for In step 902, the device selects an injection event from the injection event group and Proceed to 904. As described herein, an injection event group may include one or more drugs. The present invention may include one or more injection events associated with the delivery device. As described, the injection event occurred over a single period (e.g., 5 min total, 10 min total, etc.) (e.g., within 5 minutes of each injection) and / or the time period from each injection (e.g., within 5 minutes of each injection) It may include injection events occurring within a period of time.

[0091] In step 904, the device determines whether the selected injection event is the last of the injection event group. Determine whether the selected injection event is the last injection event. If so, the method proceeds to step 906, where the device notifies the user that the selected injection event is The selected injection event is determined to be an administered injection dose. If not, the method proceeds to step 908.

[0092] In step 908, the device determines the selected injection event and the next injection event of the event group. Whether the time between vents is greater than a first predetermined threshold (e.g., 58.5 seconds, 6 0 seconds, 60.5 seconds, 73.5 seconds, 80 seconds, etc.) to determine the time between injection events. If so, the method proceeds to step 910 and determines that the selected injection event is not longer than It is determined that this is a priming dose that was not administered to the user.

[0093] If the period is greater than the first predetermined threshold, the method proceeds to step 912, where the device a time gap rank associated with the recorded injection event is equal to or greater than a second predetermined threshold. The time gap rank can be determined, for example, by the method described further herein. is the rank of the amount of time between each successive pair of injection events in the injection event group, The second predetermined threshold may be, for example, 2, 3, 4, etc. If it is determined that the second predetermined threshold is not met, the method proceeds to step 912, where the device determining that the selected injection event is a priming dose that was not administered to the user; However, if the time gap rank is greater than or equal to a second predetermined threshold, the method proceeds to step The process proceeds to step 914 where the selected injection event is associated with an injection dose administered to the user. It is determined to be a related injection event.

[0094] Following steps 910 and 914, the method returns to step 902 and Select the next injection event of the group and repeat the process as described herein. .

[0095] In some embodiments, the selected injection event follows the selected injection event. The last injection in the injection event group if no other injection events occur within the given period. An event may be determined to be a selected event (step 904). If no other injection events occur within 4, 5, 6, etc. minutes following the injection event It can be determined that the injection event is the last injection event of the injection event group. Once this determination is made, the device can close the injection event group.

[0096] In some embodiments, the time gap rank is the number of consecutive injections of an injection event group. This can be determined by evaluating and comparing the time periods between successive shooting events. The period between injection events may be, for example, from the shortest period between successive injection events to the shortest period between successive injection events. The injection events are ordered by the longest duration between injection events and assigned a corresponding rank in ascending order. Considering the example of a first, second, and third injection event, the first and second injection events The period between the first and second injection events is 5 seconds, and the period between the second and third injection events is 3 seconds. Since there are no other injection events in the group, the period associated with the third injection event The corresponding time gap rank in this example is set to zero for the first injection event. 3 (because the 5 second time gap is the largest among all three time gaps), For two injection events, the time gap is 2 (3 seconds) for the first injection event. smaller than the t-gap but larger than the t-gap for the third injection event For the third injection event, the time gap is 1 (the 0 second time gap is the sum of the three time gaps). This is the case in the example of FIG. 10A, which is explained further below. As shown in.

[0097] 10A-10C are tables 1000, 1030, and 1060, respectively. 1 shows an example of dose determination for an exemplary injection event group, according to some embodiments. In these examples, the period between injection events for the first threshold is 73.5 seconds and the time gap for the second threshold is 1. The cap rank is 3.

[0098] Referring to table 1000 of FIG. 10A, the injection event group includes three injection events: The device selects a first injection event 1002, which is an injection event. It is determined that this is not the last injection event of the vent group. Therefore, the device then: The 5 second period between the first injection event 1002 and the second injection event 1004 is set to a predetermined If it is determined that the 5 second period is not longer than the predetermined period, the equipment The device may be configured to detect if the first injection event 1002 is associated with a priming dose that was not administered to the user. Then, the second injection event 1004 is selected. 1004 is not the last injection event, but the second injection event 1004 and the third injection event It is determined that the 3-second period between the event 1006 is not longer than the predetermined threshold of 73.5 seconds. Thus, the device detects that the second injection event 1004 is a prodrug that has not been administered to the user. Next, the third injection event 1006 is selected and determined to be associated with a priming dose. It is determined that this is the last injection event of the injection event group. Therefore, the device It is determined that the third injection event is an injection dose administered to the user. The injected dose for the injection event group designated 000 is 4 units.

[0099] Referring to table 1030 of FIG. 10B, the injection event group includes five injection events: The first injection event 1032 is selected and the device It is determined that the dose is not the final dose of the vent group. Therefore, the second injection event 103 The period preceding 4 (5 seconds) is compared to a predetermined threshold of 73.5 seconds. Since the duration of the injection is not greater than the threshold, the device determines that the first injection event 1032 was injected by the user. Next, a second injection event 1034 is determined to be a priming dose that has not been administered. is selected and the device determines that it is not the last injection event in the injection event group. The period between the second injection event 1034 and the third injection event 1036 is 81 seconds. The device then determines that the second injection event is greater than the predetermined threshold of 73.5 seconds. A time gap associated with the period between the first injection event 1034 and the third injection event 1036. The device determines that the plank 4 is greater than or equal to the predetermined threshold 3. The device determines that the second injection event Next, a third injection event 1036 is determined to be associated with an injection dose administered to the user. The device will select the injection event if it is not the last injection event in the injection event group. The 48 seconds between the third injection event 1036 and the fourth injection event 1038 are Because the duration of the second is not greater than the 73.5 second threshold, the device triggers a third injection event 1036 is a priming dose that was not administered to the user. Injection event 1038 is the last injection event in the injection event group, so Therefore, the doses shown in Table 1030 are related to the injected doses administered to the patient. The injection dose for the injection event group is 5 units.

[0100] Referring to table 1060 of FIG. 10C, the injection event group includes two injection events: The first injection event 1062 is selected by the device. , it is determined that the injection event is not the last injection event of the injection event group. The period between the first injection event 1062 and the second injection event 1064 (81 seconds) is within a predetermined threshold. Since it is longer than 73.5 seconds, the device proceeds to evaluate the time gap rank. The associated time gap rank 1 is not equal to or greater than the predetermined threshold 3. The arrangement is such that the first injection event 1062 is a priming dose that has not been administered to the user. Next, the second injection event 1064 is selected and the injection event group is determined to be Since this is the last injection event, it is determined to be the injection dose delivered to the user. Therefore, the injection dose for the injection event group shown in table 1060 is 3 units.

[0101] According to some embodiments, dose determination of an injection event can be performed in real time. (e.g., instead of generating an injection event group, one or more doses of information can be included. When received, the device selects the current injection event and adjusts the dose size to a first predetermined threshold. values ​​(e.g., dosage sizes of 8 units, 9 units, 10 units, 11 units, etc.) If the dose size is equal to or greater than a first predetermined threshold, the device may However, the dosage size may be determined to be related to the dose administered to the user. If is less than or equal to the first predetermined threshold, the device compares the dosage size to a second predetermined threshold. For example, the second predetermined threshold can be a dosage size of 3 units, 4 units, 5 units, etc. If the dose size exceeds a second predetermined threshold, the method may include determining whether the expected dose since the last dose is greater than the expected dose. We proceed to compare the time to a given period (e.g., 8 seconds, 9 seconds, 10 seconds, 11 seconds, etc.) Upon determining that the time since the last administration is greater than a predetermined period, the device may: It may be determined that the current injection event is associated with an injection dose administered to a user. The device will detect all other injection events (e.g., where the dose size does not exceed a second predetermined threshold). and / or the time since the last dose is not longer than the prescribed period) It can be determined that this was a priming dose that was not administered.

[0102] FIG. 11 illustrates a computerized process described herein, according to some embodiments. FIG. 11 is a diagram of an example system 1100 for implementing the logic "control logic," "application," "process," "method," "algorithm," and and the term "instructions" includes one or more programmable processors, application specific integrated circuits Application specific integrated circuits (ASIC), field programmable gate arrays (FPGA), digital signal processors It can run on a digital signal processor (DSP), hardwired logic, or a combination of both. This may include software and / or firmware. For example, the various logics may be implemented in any suitable manner and may be implemented in accordance with the implementations disclosed herein. The system 1100 includes a computer that is in wireless communication with a drug delivery device 1140. The computing device 1110 also includes a network The device may be in communication with a server 1160 via a network 1150 .

[0103] The computing device 1110 is illustratively a mobile device such as a smartphone. Alternatively, for example, a laptop, desktop, tablet or server computer. The present invention may be implemented using any suitable computing device, including but not limited to a personal computer. The computing device 1110 includes a processor 1112, a memory 111, and a 6. Display / user interface (UI) 1118 and communication device 1119 include.

[0104] The processor 1112 is stored in the memory 1116 of the computing device 1110. At least one processor that executes the software and / or firmware The software / firmware code is executed by the processor 1112. and instructions that cause the processor 1112 to perform the functions described herein. The instructions illustratively include control logic / programming instructions that operate to implement the functions described herein. The memory 1114 includes an application 1114. The memory 1114 is accessible by the processor 1112. The memory 1114 may be a single storage device. The storage device may be a storage device or multiple storage devices, and may be internal or external to the processor 1112. The media may be located in the storage area and may further include both volatile and non-volatile media. The memory 1114 may include random access memory (RAM), read-only memory (RO M), Electrically Erasable Programmable Read-Only Memory (EEPROM), Flash Memory, Magnetic storage device, optical disk storage, or configured to store data; and Any other suitable media accessible by the processor 1112 is included.

[0105] The computing device 1110 communicates with a processor 1112 and provides a user interface to the system. Provide input data and receive system-generated data, information and prompts The display / user interface 1118 is operable to display the user interface. The user interface 1118 receives user input and provides the user input to the system. In the illustrated embodiment, the user interface includes at least one input device for inputting a user command. The touch screen 1118 is operable to display data and receive user input. A graphical user interface (GUI) that includes a display. The lean display allows the user to see the presented information, menus, buttons and other data Allows you to interact with and receive information from the system and provide user input to the system Alternatively, a keyboard, keypad, microphone, mouse pointer or other Suitable user input devices may be provided.

[0106] The computing device 1110 may include a network that allows the computing device 1110 to communicate with other devices. It further includes a communication unit 1119 that allows for establishing a wired or wireless communication link. The communication device 1119 includes one or more wireless antennas and and / or signal processing circuits and / or physical wires for transmitting and receiving data. The communication device 1119 may include one or more ports for receiving a The signaling device 1110 includes a communication link 1103 with a drug delivery device 1140. One or more short-range communication links may be established. Such short-range communication links may include radio frequency (RF) Communications (e.g., Wi-Fi, Bluetooth, Bluetooth Low Energy (B LE), Near Field Communication (NFC), RFID, infrared transmission, microwave transmission and Any known wired or wireless communication technique or process, including but not limited to, wired and light wave transmission. Such short-range communications links may utilize unidirectional links (e.g., data data flows only from the device 1140 to the computing device 1110) or bidirectionally. The communication device 1119 may be either a The computing device 1110 also includes a network 1150 and communication links 1150. 104 and 1105 to establish a long distance communication link with the server 1160. The server 1160 may be separate from the computing device 1110, e.g. , may be located in different buildings, different cities, or even different countries or continents. 1150 may be a computing adapted to relay information from the logging device 1110 and / or from the server 1160. This may include any cellular or data network. Examples of networks include cellular networks, metropolitan area networks (MANs), and wireless networks. This includes wide area networks (WANs) and the Internet.

[0107] The drug delivery device 1140 illustratively delivers one or more doses of a drug to a patient, with each dose being Measure and / or record the time and amount of the quantity and transmit this information to a computing device 11 10. In some embodiments, the drug The delivery device 1140 is configured to store and / or deliver one or more doses of a drug to a person. As used herein, the term "drug" or "drugs" refers to The term refers to insulin, insulin derivatives such as insulin lispro or insulin glargine. This refers to insulin analogs, and / or insulin derivatives, including but not limited to daraglutide or GLP-1 receptor agonists such as liraglutide, glucagon, glucagon analogues, and glucagon-related Lucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxy and the use of oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies and the above-mentioned devices. The device may also refer to one or more therapeutic agents, including any therapeutic agent capable of being delivered by a Drugs such as those used in the treatment of chronic conditions may be formulated with one or more excipients. The device is operated by a caregiver or health care professional to deliver drugs to a person. The delivery device 1140 is a reusable device that can be refilled with drug once the drug supply is depleted. The drug supply may be configured as a storage unit or may be discarded and replaced once the drug supply is depleted. The drug delivery device 114 may be configured as a disposable device designed to be 0 includes a processing circuit 1142, a dose detection sensor 1144, a communication device 1146, a drug reservoir The processing circuit 1142 includes a dose adjusting mechanism 1148, and a dose adjusting mechanism 1149. The dose detection sensor 1144 may include any of the types of processing circuitry that can be used to detect the delivered dose. Any suitable sensor may be included to detect and / or record the time and amount of administration. The communication device 1146 may communicate with the drug delivery device 1140 via the communication link 1103. The drug reservoir 1110 may be connected to a computing device 1110 via a USB port. 148 may be of a size sufficient to hold enough drug for multiple doses, The dose adjustment mechanism 1149 allows the user to adjust the dosage for injection of the drug delivery device. This makes it possible to do so.

[0108] The server 1160 illustratively communicates with computing devices via the network 1150. 1110, process the information, and optionally and configured to transmit a response, notification, or instruction to the computing device 1110 in response. The server 1160 may include a processing circuit 1162, a memory 1164, and any other computing device. The processing circuit 1162 may include any of the possible types described above. The processing circuit 1162 may include any of the processing circuits of the memory of the server 1160. The software and / or firmware stored in 1164 may be executed. The software / firmware code, when executed by the processing circuit 1162, performs the functions described herein. The memory 1164 also includes historical information and / or instructions for performing the functions described in the document. or information about one or more patients, such as medical information (e.g., medication records, medical history, etc.) The information received from the computing device 1110 may be configured to be stored. Alternatively, the information transmitted to the computing device 1110 may be stored in the memory 1164. The memory 1164 may include any of the possible types of memory described above. The communication device 1166 may include a server 1160 connected to the communication link 1105, a network 1150 and the computing device 1110 via communication link 1104. This makes it possible.

[0109] In some embodiments, the computing device 1110 may include a network 1150 and / or may operate without being connected to a server 1160.

[0110] In other embodiments, the system 1100 may be modified by adding additional components. For example, the server 1160 may include multiple networks that cooperate to process information. Such a networked server may be configured as a networked server 1160. Such an arrangement may be referred to as a "cloud" of servers performing the functions described herein. The server 1160 may communicate with multiple computing devices via the network 1150. Each computing device 1110 can then optionally Optionally, it may be connected to one or more drug delivery devices 1140 .

[0111] In some embodiments, the techniques described herein include reporting cartridge change events. Reusable insulin pens, including reusable insulin pens that In some embodiments, the drug delivery device may be a reusable drug delivery device. The device may generate data indicative of a cartridge change time as described herein, can be used to process the injection data based on reservoir changes.

[0112] In some embodiments, some or all of the techniques described herein (e.g., Process 200, 400, 450, 700, and / or 900) is a drug delivery device For example, the drug delivery device may determine the injection event group. The injection dose may include a processing circuit configured to: (e.g., priming and injection events, including proper handling of cartridge changes) In some embodiments, the drug delivery device is Attach the injection event group and / or injection dose to the drug delivery device. to a separate device, such as a smartphone or module that can It is possible.

[0113] In some embodiments, some or all of the techniques described herein (e.g., Process 200, 400, 450, 700, and / or 900) can be used with smartphones or or a drug delivery device, or The application may be running on a remote server (e.g., server 1160), a remote operating device (e.g., operating device 1110), or a remote server (e.g., server 1160). The drug delivery device may be implemented by a device separate from the drug delivery device, such as by a drug application. The delivery device may receive injection data and / or injection event groups and / or device change information. The device may be configured to transmit the processed data, such as the device status, to a separate device. In some embodiments, the drug delivery device may be a disposable drug delivery device. Some examples of single-use drug delivery systems are listed in the International Application Publication No. 2018 / 08 / 14, filed on August 14, 2018 under the title "M EDICATION DELIVERY DEVICE WITH SENSING S The present invention is described in further detail in International Publication No. WO 2019 / 040313, entitled "Methods for the Preparation of Fluorescent Microspheres in a Microtubule-Based Microtubule," entitled "Methods for the Preparation of Fluorescent Microtubules in a Microtubule-Based ...-Based Microtubule- No. 6,399,433, the contents of which are incorporated herein in their entirety.

[0114] In some embodiments, the drug delivery device includes wireless transmission capabilities, dose detection capabilities, and / or In some embodiments, the reusable electronic module may not include any processing capabilities. The drug delivery device may be fitted or detached to provide one or more of these functions. For example, a reusable electronic module can be added to each injection delivery device. A second device detects the amount of medication associated with the event and processes the injection event data. Such reusable electronic modules can be configured to report information to a device. Some examples of the patents have an international filing date of February 22, 2018 and are listed in the DOSE DET ECTION AND DRUG IDENTIFICATION FOR A MED ICATION DELIVERY DEVICE" International Release No. 2018 / No. 160,425, the contents of which are incorporated herein in their entirety. As another example, a reusable electronic module may be attached to a drug delivery device. may be configured to report information when it is inserted and / or removed from the device. This can be used by the receiving device to determine the change information.

[0115] In some embodiments, the processes 200, 400, 450, 700, and / or Alternatively, 900 may be refined based on user feedback. 200, 400, 450, 700, and / or 900 for each injection event received The dose of priming agent administered to the user or not administered to the user In some embodiments, the user may classify the dose as a dose of the drug. 50, 700, and / or 900 correctly classify a particular injection event. For example, a user may manually provide feedback indicating whether a particular injection is correct. Confirm that the event was correctly classified as an administered dose versus a priming dose, or The user may select the appropriate The user can modify and / or change the labels used in the process 200. Check or correct classifications output by the 400, 450, 700, and / or 900 When you provide corrective feedback, this feedback is used to change the process. , future injection events can be classified more accurately. For example, After sufficient user feedback has been collected over a period of time (e.g., days, weeks, or months), Once collected, user feedback can be used to refine thresholds or the accuracy of the process. A machine learning model can be trained that adjusts timers in the process to The user feedback used to train the machine learning model is generated from a single user. Or it may be obtained from a population of users. A non-limiting set of thresholds and / or timers that may be adjusted include: (i) step 206 (ii) the duration of the injection event window at the first threshold referenced in step 704; (iii) the duration of the second threshold referenced in step 710; (iv) the (v) the third threshold size, referenced in step 908; threshold, and / or (vi) a second predetermined threshold referenced in step 912. Tuning the machine learning model and / or thresholds and / or timers may be done by computing The drug delivery device 1140 and / or the server 1110 may be implemented in the By continuously learning from user feedback, Machine learning models such as The 900's accuracy can be continually refined and improved.

[0116] Adjusting the thresholds and / or timers of the above-mentioned processes may Although the specific programmable features of the However, in some embodiments, certain process steps In addition to adjusting the thresholds and / or timers in You may also add, delete, rearrange, and / or modify any of the steps of the processes described above. By editing Process 200, 400, 450, 700, and / or 900 For example, such user feedback may be used to modify Derive new data features (e.g., dose size, time between doses, sequence of doses, and In addition to the data features such as the medication time gap rank mentioned above, such new The new data capabilities are integrated into entirely new processes. The process may also include the steps of processes 200, 400, 450, 700, and / or 900 described above. It can be used to facilitate switching from one to another of the aforementioned processes.

[0117] The machine learning models that can make these more extensive adjustments to the process are threshold It requires a lot of training data, computational resources, and and / or memory. Thus, some embodiments may A two-level model can be used to regulate the process. You can use a machine learning model to tune the thresholds and timers. This simpler machine learning model is relatively frequent (e.g., weekly) and requires relatively modest computational resources and / or memory The present invention may be implemented in a device (e.g., computing device 1110) having a The set of user feedback used to train such a model is The second, more complex approach is to use a set of metric metric data from a single user, or from a small population of users. Use machine learning models to improve process 200, 400, 450, 700, and / or 900. This more complex machine learning model can implement the more extensive changes mentioned above. Relatively infrequent (e.g. monthly) and with a larger amount of training data (e.g. more a larger population of users) and / or larger amounts of computing resources and / or memory This second machine learning model may be implemented on a device (e.g., server 1160) having When the IDE outputs a revised process, this revised process is 110 and / or the drug delivery device 1140 to Injection events can be categorized.

[0118] The various methods or processes outlined herein may be implemented in a variety of operating systems. or platforms. Moreover, such software may be coded as programmable software. Appropriate programming language and / or programming or scripting tools It can be written using either The program may be compiled into executable machine code or intermediate code that is executed.

[0119] In this regard, various inventive concepts may be implemented using one or more computers or other processors. One or more programmatically encoded small objects that, when implemented, implement various embodiments of the present invention. At least one non-transitory computer-readable storage medium (e.g., computer memory, The above floppy disks, compact disks, optical disks, magnetic tapes, flash Circuits in memory, field programmable gate arrays or other semiconductor devices The non-transitory computer-readable medium or media may be embodied as a , may be portable, so that one or more programs stored thereon may be stored in the manner discussed above. Any computer resource may be loaded onto the computer to implement various aspects of the present invention as described herein. It can be downloaded.

[0120] The terms "program," "software," and / or "application" is used herein in a general sense and applies to various embodiments as discussed above. The present invention may be adapted to program a computer or other processor to implement various aspects. Any type of computer code or set of computer executable instructions used in Further, according to one embodiment, there is provided one or more components which, when executed, perform the method of the present invention. A computer program need not reside on a single computer or processor, Modularization may be used between different computers or processors to implement various aspects of the present invention. It should be understood that the software may be distributed via a mailing list.

[0121] Computer-executable instructions may be implemented by one or more computer programs, such as program modules. The program may take many forms, including those executed by a program or other device. It contains routines, programs, and programs that perform particular tasks or implement particular abstract data types. These include programs, objects, components, and data structures. Typically, The functionality of the modules may be combined or separated as desired in various embodiments. It can be dispersed.

[0122] Also, the data structures may be stored in a non-transitory computer-readable storage medium in any suitable form. A data structure may have fields that are related by their location within the data structure. Such relationships may also be non-temporary fields that convey relationships between fields. By allocating storage to a field with a location in a computer readable medium However, any suitable mechanism may be used to achieve this. Data linking, including through the use of pointers, tags, or other mechanisms that establish relationships Relationships can be established between information within the fields of a data structure.

[0123] Various inventive concepts can be embodied in one or more methods, examples of which are provided. The actions performed as part of the methods may be ordered in any suitable way. Thus, although shown in the exemplary embodiment as sequential operations, some operations may be performed simultaneously. Embodiments in which operations are performed in a different order than illustrated, which may include performing operations at different times. can be constructed.

[0124] As used herein in the specification and claims, the indefinite articles "a" and " "an" shall be understood to mean "at least one" unless expressly indicated to the contrary. As used herein in the specification and claims, one or more The phrase "at least one" in relation to a list of elements of , at least one element selected from any one or more of the elements in the list of elements It should be understood to mean each and every element specifically listed within the list of elements. It is not necessary to include at least one of all elements in the list of elements, but any combination of elements in the list of elements. This does not exclude combinations of Any elements other than those specifically identified in a list of elements shall be construed as including those elements specifically identified. It may be present optionally, whether related to the element or not.

[0125] As used herein in the specification and claims, "and / or" refers to The phrase "d / or" refers to the elements so combined, i.e., in some cases, conjunctively "either or both" of elements that are otherwise disjunctively present "and / or" should be understood to mean "or both." Multiple elements listed must be interpreted in the same way, i.e. "one or more" of the specified elements. Therefore, elements other than those specifically identified shall not be construed as being related to those elements specifically identified. These may be present optionally, whether or not they are associated with each other. Thus, as non-limiting examples, Therefore, references to "A and / or B" are not intended to be limiting unless expressly stated in the specification or elsewhere in this document. When used in combination with a language without A, in one embodiment, A alone (optionally with B or more) In another embodiment, only B (optionally including elements other than A) is mentioned. In yet another embodiment, both A and B (optionally including other The term may refer to a particular aspect of a technology (including elements thereof).

[0126] As used in this specification and claims, "or" means any of the elements defined above. and / or." For example, items in a list When separating terms, "or" or "and / or" shall be construed as inclusive. That is, at least one of the elements or list of elements, but not just more than one and, optionally, additional unlisted items. "Only one of" or "the correct one of" shall be used. "exactly one of," or when used in the claims Only terms clearly indicated to the contrary, such as "consisting of," , refers to the inclusion of exactly one element out of a set of elements or a list of elements. As used in the specification, the term "or" means "either," "one of," "only one of," or "exactly one of" ", it means an exclusive choice (i.e., "either one or the other but not both) "One or the other but not both" "consisting essentially of" should be interpreted as meaning "(i.e., of)" is used in the field of patent law when used in the claims. shall have its ordinary meaning.

[0127] In the claims, ordinal numbers such as "first," "second," and "third" are used to modify claim elements. The use of the term does not, by itself, imply any priority, precedence, or other ordering of one claim element over another. The order or chronological order of claim elements (the order in which method actions are performed) Such terms do not imply ordering, but rather refer to a particular named claim element as being the same as the claim element itself. It is used only as a label to distinguish it from other elements with the same name (unless it is an ordinal (depending on the use of the term).

[0128] The phraseology and terminology used herein is for the purpose of description and not of limitation. "Including," "comprising" "having," "containing," "in The use of "Volving" and variations thereof is subject to the terms and conditions set forth therein and in the appended claims. This means that additional items are included.

[0129] Although several embodiments of the present invention have been described in detail, those skilled in the art will recognize various modifications and variations. Modifications will readily occur to those skilled in the art. Such modifications and improvements are within the spirit and scope of the invention. Accordingly, the foregoing description is by way of example only and not intended to be limiting. It is not intended to be illustrated.

Claims

1. 1. A computer-implemented method for determining a dose injected into a user by one or more drug delivery devices, the method comprising: accessing data indicative of an injection event group including one or more injection events associated with one or more drug delivery devices, each of the one or more injection events occurring within a predetermined time period, and each of the one or more drug delivery devices: a dose adjustment mechanism that allows a user to adjust the dosage for injection of said drug delivery device; a reservoir of sufficient size to hold multiple doses of medication; one or more sensors for detecting the amount of medication dispensed per injection; and a wireless communication unit for communicating the amount of the dispensed dose and the time of dispense. determining the dose administered to the user, said determining comprising: determining whether the injection event group includes a first injection event and a second injection event that occurs after the first injection event; determining, upon determining that the injection event group includes the first injection event and the second injection event, whether the first injection event is associated with a dose administered to the user or a priming dose not administered to the user based on a time period between the first injection event and the second injection event; determining whether the first injection event is associated with a dose administered to the user or a priming dose not administered to the user based on a period between the first injection event and the second injection event; determining whether the period of time is less than a second predetermined threshold; determining that the first injection event is associated with the priming dose that was not administered to the user upon determining that the duration is less than the second predetermined threshold; and upon determining that the duration is not less than the second predetermined threshold, determining the dose administered to the user based on a dosage size of the first injection event. A computer implemented method.

2. 2. The computer-implemented method of claim 1, wherein the predetermined period of time is between 4 and 6 minutes.

3. 2. The computer-implemented method of claim 1, wherein determining a dose administered to the user comprises determining whether an injection event of the injection event group is associated with a dose administered to the user or a priming dose not administered to the user based on a dosage size of the injection event.

4. determining whether the dose size is greater than a first predetermined threshold; determining that the injection event is associated with the dose administered to the user upon determining that the dose size is greater than the first predetermined threshold; 4. The computer-implemented method of claim 3, further comprising, upon determining that the dosage size is not greater than the first predetermined threshold, determining the dose administered to the user based on whether a next injection event occurs after the injection event of the injection event group.

5. 5. The computer-implemented method of claim 4, wherein the first predetermined threshold is a dosage size of between 9 and 11 units.

6. determining that the dose size is not greater than the first predetermined threshold; determining whether a next injection event occurs after the injection event of the injection event group; determining, upon determining that there is no next injection event in the injection event group, that the injection event is associated with the dose administered to the user; 5. The computer-implemented method of claim 4, further comprising, upon determining that there is a next injection event in the injection event group, determining the dose administered to the user based on a time period between the injection event and a next injection event in the injection event group.

7. 2. The computer-implemented method of claim 1, wherein the second predetermined threshold is a period of time between 75 and 85 seconds.

8. determining the dose administered to the user based on the dose size of the first injection event; determining whether the dose size is greater than a third predetermined threshold; determining that the first injection event is associated with the dose administered to the user upon determining that the dose size is greater than the third predetermined threshold; and determining that the first injection event is associated with the priming dose that was not administered to the user upon determining that the dose size is not greater than the third predetermined threshold.

9. 9. The computer-implemented method of claim 8, wherein the third predetermined threshold is a dosage size of 4 to 5 units.

10. A computer program comprising instructions, which when executed by one or more processors of a computing device are operable to cause the one or more processors to perform a method according to any one of claims 1 to 9.

11. A system comprising a memory for storing instructions and a processor configured to execute said instructions to perform the method of any one of claims 1 to 9.

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