Method, apparatus and device for determining absolute time of one or more recorded dose events performed with a medical device

Abstract

A method for determining an absolute time T dose (e) for one or more recorded dose events (e1 to ez) performed with a medical device, where e characterizes a particular dose event, where the one or more dose events are recorded in a dose event record, where e represents a particular dose event. At least one part of the dose event record is received (S100) or can be received by the receiving unit (71), and wherein the T dose (e) is determined (S104) on the basis of the at least one time information from the recording unit (11) and the at least one time information from the receiving unit (71), by which the dose event is recorded for the dose event record.

Description

Background Art

[0001] In pharmaceutical-based treatments, it is often important to determine not only the amount of the pharmaceutical administered to a patient but also the exact time at which the administration occurs.

[0002] For example, considering diabetes treatment, if a patient takes too much insulin over a certain period of time, this can lead to hypoglycemia, which can have serious consequences for the patient. Therefore, in order not to exceed a critical amount of insulin, such as a critical daily dose, over a certain period, the patient needs to keep track of the administered dose and the administration time.

[0003] Typically, insulin doses are administered using a pharmaceutical delivery device. Such a pharmaceutical delivery device can provide a function of recording the amount of the pharmaceutical and the time information of the administered pharmaceutical, for example, in a dose record or a dose log. Alternatively or additionally, there are add-ons for the pharmaceutical delivery device that can provide this function.

[0004] Typically, the time information is obtained using a timer (e.g., a real-time clock) within the pharmaceutical delivery device or within the add-on.

[0005] Based on the information obtained using the timer, the dose time T 剂量 (e) of the administered dose is calculated in order to generate a dose log based on which a patient or a healthcare professional can monitor the dose administration.

[0006] This means that, according to the prior art, the determination of the dose time depends entirely on the accuracy of the real-time clock within the pharmaceutical device or within the add-on.

[0007] Assuming that this real-time clock can never be completely accurate, there will always be a slight deviation between the registered time and the real time of the administered dose. This deviation or drift increases over time, and thus the inaccuracy in the dose log will increase. This is potentially dangerous for the patient. Summary of the Invention

[0008] The object of the present disclosure is to provide an improvement related to determining the absolute time of a recorded dose event.

[0009] The terms "drug" or "pharmaceutical" are used synonymously herein and describe a pharmaceutical preparation that contains one or more active pharmaceutical ingredients or their pharmaceutically acceptable salts or solvates and optionally a pharmaceutically acceptable carrier. The drug or pharmaceutical can be used for a limited duration or regularly for chronic disorders. Further explanations regarding "drug" or "pharmaceutical" can be found in the last part of the description of the exemplary embodiments.

[0010] As used herein, the term "distal" refers to the direction of a medical device, a medicament delivery device, or a medicament container along which medicament is expelled. Accordingly, the term "proximal" refers to the opposite direction. With respect to a pen-shaped medicament delivery device, the term "distal" refers to the direction toward the injection site and / or the tip of the device's injection needle. Accordingly, the term "proximal" refers to the direction away from the injection site and / or the tip of the device's injection needle.

[0011] As used herein, the term "absolute time" refers to standard time, such as the so-called Coordinated Universal Time or UTC, which is the primary time standard used to regulate time and clocks around the world. Standard time can be a time that is easily interpretable by a user.

[0012] As used herein, the expression "dose event" relates to any action or event that can be performed with a medical device (e.g., a medicament delivery device) configured to contain a medicament. Among other things, such an action or event can be setting and / or selecting the amount to be output (e.g., ejected or expelled) from the medical device, i.e., the medicament dose. The amount can be selected by a user action. Alternatively or additionally, the expression "dose event" relates to any action or event that can be performed with a medical device to output a medicament from the medical device, such as expelling and / or ejecting a certain medicament dose (which may have been previously selected) that may be injected into a patient's body (e.g., via a needle). It should be understood that the medicament can also be administered in other ways.

[0013] A "dose" can be a part or the entire amount / quantity of a medicament that is set, selected, output, expelled, and / or ejected from a medical device in a single procedure. In particular, this is not limited to unit-based quantification of the medicament. However, if a dose can only be quantified in increments, a "dose" can include one or more increments.

[0014] As used herein, the expressions "time" and "time point" can be used synonymously and describe time information related to certain actions. This can be the start of the transmission of at least a part of a dose event record from a recording unit to a receiving unit, or the end of such transmission, where the start can be indicated by time information from the recording unit and the end can be indicated by time information from the receiving unit.

[0015] This object is achieved by the subject matter disclosed herein, for example by the subject matter defined in the appended independent claims. Advantageous modifications and developments are subject to the dependent claims and / or are set forth in the following description.

[0016] One aspect of the present disclosure relates to a method for determining the absolute time T of one or more recorded dose events (e1 to e z ) performed with a medical device 剂量The method of (e), where e represents a specific dosing event, and where the index z is a positive integer greater than or equal to one.

[0017] The one or more dosing events are recorded in a dosing event record, which includes information characterizing the one or more dosing events contained in the dosing event record.

[0018] The dosing event record can be, for example, a continuous record of all dosing events performed with a medical device while delivering a medicament from one reservoir or multiple reservoirs.

[0019] At least one part of the dosing event record is received or receivable by a receiving unit. The at least one part of the dosing event record can include the one or more dosing events e1 to e z . The dosing events can be consecutive dosing events or selected dosing events recorded in the dosing event record.

[0020] The at least one part of the dosing event record can include information related to at least one, any selected plurality, or all of the following: a unique dosing event identifier, a dose amount, and / or time information T related to the dosing event of the recording unit 时间戳 (e), the time information indicating the time at which the dosing event e is recorded in the at least one part of the dosing event record.

[0021] The dosing event identifier can be unique, for example, within the dosing event record or overall. The dosing event identifier can be a unique combination of numbers, text, or symbols based on which a specific dosing event can be uniquely identified. The dose amount can be the amount or dosage of the medicament set, selected, or output (e.g., sprayed, discharged, etc.) in a single dosing event.

[0022] Determine the absolute time T 剂量 (e), the recording unit records the dosing event for the dosing event record.

[0023] In one embodiment, the time information from the recording unit can include one, any selected plurality, or all of the following: T timestamp (e), T RTC_ transmission and T RTC_FDE . T timestamp (e) can be the time information related to the dosing event of the recording unit, which indicates the time at which the dosing event e is recorded in the dosing event record. T RTC_ transmission can be the time information related to the transmission of the recording unit, which indicates the time at which the at least one part of the dosing event record containing the dosing event e is transmitted for reception by the receiving unit. T RTC_FDEIt may be the time information of the first dose event of the recording unit, which indicates the time when the first dose event is recorded by the recording unit in the dose event record.

[0024] In one embodiment, the time information from the recording unit may include one or all of the following: the T timestamp (e) and T RTC_ transmission, for example, only including the above two items. In other words, the time information from the recording unit may not include T RTC_FDE .

[0025] The time information from the receiving unit may include the time T of the receiving unit 客户 , which indicates the time when the receiving unit receives the at least one part of the dose event record. T 客户 may be time information synchronized with absolute time (e.g., UTC).

[0026] The method may further include the step of evaluating the at least one part of the dose event record regarding the occurrence of irregularities in the time information included in the at least one part of the dose event record received by the receiving unit.

[0027] The evaluation may be based only on the information stored in the dose event record (e.g., T 时间戳 (e) or the unique dose event identifier) and / or the time information from the recording unit (e.g., T RTC_ transmission). Alternatively, the evaluation may be based on the information stored in the dose event record and / or the time information from the recording unit combined with the time information from the receiving unit (e.g., T 客户 ).

[0028] The evaluation of the occurrence of irregularities may provide the following advantages: when determining the absolute time T z of one or more recorded dose events e1 to e 剂量 (e), such irregularities can be considered. That is, depending on when the dose event is recorded regarding the irregularity, different determination functions can be used to determine T 剂量 (e) of different dose events. Advantageously, this can improve the accuracy of the determination.

[0029] The recording unit may include a timer, which is configured to provide time information for the recording unit, and the time information is T RTC . If not reset, the value of T RTC increases continuously. The timer of the recording unit may include a real-time clock.

[0030] In one embodiment, T RTCThe initial value of can be set according to absolute time (e.g., Coordinated Universal Time UTC) during the manufacture of the recording unit. That is, T RTC 's initial value can be set to correspond to the absolute time at the moment when the timer starts running (e.g., at the moment when the recording unit is connected to the energy source during assembly).

[0031] In one embodiment, the value of T RTC at the moment when the first dose event is recorded in the dose event record can be stored as T RTC_FDE . In one embodiment, the value of T RTC at the moment when the first dose event is recorded in the dose event record may not be stored.

[0032] In one embodiment, the value of T RTC can be set to zero when the first dose event is recorded in the dose event record. In one embodiment, the value of T RTC can be set to zero after at least a part of the dose event record has been transmitted for reception by the receiving unit and / or after the transmitted part has been received by the receiving unit. In one embodiment, the value of T RTC can be set to zero each time a part of the dose event record has been transmitted for reception by the receiving unit and / or after the transmitted part of the dose event record has been received by the receiving unit. Setting the value of T RTC to zero after a part of the dose event record has been transmitted for reception by the receiving unit can provide the following advantage: The time deviation between the timer of the recording unit and the accurate real-time time (e.g., UTC) may have a relatively small negative impact on the accuracy of the determination of T 剂量 (e).

[0033] The time information T RTC can be in a format that can be intuitively read by a person, such as the UTC format. Alternatively, T RTC can be in a format that cannot be intuitively read by a person, such as UNIX time (EPOCH time). This format may be beneficial for processing time information.

[0034] The irregularity can be a reset event of the recording unit, at which the timer of the recording unit is reset, such that T RTC changes to the default value of T RTC . The default value can be any predefined value different from zero. Alternatively, the default value can be zero.

[0035] In an embodiment, the irregularity can be a temporary stop or suspension of T RTC .

[0036] In one embodiment, the occurrence of an irregularity can be evaluated based on time information from the receiving unit and / or based on information stored in the dose event record and / or based on time information from the recording unit. The occurrence of an irregularity can be evaluated based on the detection of a change (e.g., a step change) in a variable Δ that indicates the time deviation between the recording unit and the receiving unit.

[0037] In one embodiment, Δ can be determined after a time m at which at least one portion of the dose event record is transmitted for reception by the receiving unit and after a time p at which the at least one portion of the dose event record is received by the receiving unit. Δ can be determined based on time information from the recording unit and time information from the receiving unit (e.g., T RTC_m and T 客户_p ). T RTC_m can be the transmission-related time information of the recording unit that indicates the time m at which the at least one portion of the dose event record is transmitted for reception by the receiving unit, and T 客户_p can be the time information from the receiving unit that indicates the time p at which the at least one portion of the dose event record is received by the receiving unit.

[0038] In one embodiment, Δ can be determined according to the following equation:

[0039] Δ = T 客户_p - T RTC_m .

[0040] In one embodiment, Δ can be determined each time a portion of the dose event record is received by the receiving unit. Alternatively, Δ can be determined less frequently, e.g., only every second, third, fourth, fifth, tenth, twentieth, or fiftieth time a portion of the dose event record is received by the receiving unit.

[0041] One, several, or each determined value of Δ can be stored in the memory unit as Δ current for further processing at a later time point. In one embodiment, if Δ current is determined more than once, it can either be updated each time such that only the most recent Δ current is stored. Alternatively, more than one or all determined values of Δ current can be stored in the memory as Δ current_i with an increasing index i.

[0042] Except for minor drifts due to design tolerances of the electronic components of the recording unit and / or the receiving unit, Δ can remain substantially constant when there are no irregularities in the dose event record. Thus, in one embodiment, the occurrence of an irregularity in the dose event record can be evaluated based on the detection of a change (e.g., a step change) in the variable Δ.

[0043] In one embodiment, this change can be detected by comparing the most recent value of Δ with one of the stored Δ current_i or the stored Δ current. For making such a comparison and the resulting assessment of the occurrence of irregularities in the dose event record, it is advantageous to compare more than one Δ current_i with Δ.

[0044] In one embodiment, if no part of the dose event record has been transmitted previously such that there is no Δ current_i or Δ current available for determining the change, then the presence of a reset of T in the determination period can be determined based on the information stored in the dose event record. For example, if the T RTC (e) of a subsequent dose event 时间戳 does not increase, this indicates that a reset of T RTC has occurred between these dose events. Alternatively or additionally, irregularities can be detected based on the unique dose event identifiers of two or more dose events in combination with the corresponding T 时间戳 (e) of said dose events. Considering the dose event identifiers of several dose events allows detection of trends such that irregularities can be detected even if the T 时间戳 (e) increases continuously.

[0045] The method can include the step of defining a determination period in at least one part of the dose event record received by the receiving unit. The determination period can include one or more dose events e 剂量 for which T i is to be determined, where k≥i≥1. k

[0046] The determination period can be defined based on the dose event identifiers of the dose events e i to e k recorded in the at least one part of the dose event record, for which T 剂量 (e) is to be determined.

[0047] In one embodiment, e i to e k can be dose events for which T 剂量 (e) has not been determined previously. Alternatively, at least one of e i to e k can be a dose event for which T 剂量 (e) has been determined one or more times previously. Including dose events for which T 剂量 (e) has been determined previously in the determination period may make the method more robust and accurate.

[0048] In one embodiment, the determination period may be selected by a user, for example, via a user interface operatively connected to the receiving unit.

[0049] In one embodiment, the determination period may extend over the entire length of the received portion of the dose event record.

[0050] A determination function may be used to determine the absolute time T i of a particular dose event e k in the one or more dose events e 剂量 (e) within the determination period.

[0051] The determination function f may be a function of the time information from the recording unit and the time information from the receiving unit.

[0052] In one embodiment, the determination function f may be such that Tdose(e) = f(Tcustomer, T RTC_ transmission, T 时间戳 (e)).

[0053] In one embodiment, the determination function f may be a function of the difference between the time information from the receiving unit and different time information from the recording unit (e.g., T RTC_ transmission - Ttimestamp(e)), such that Tdose(e) = f(Tcustomer, (T RTC_ transmission - Ttimestamp(e))).

[0054] In one embodiment, the determination function f may be a function of the difference between the time information from the receiving unit and the time information from the recording unit (e.g., T RTC_ transmission - Ttimestamp(e)), such that Tdose(e) = f(Tcustomer - (T RTC_ transmission - Ttimestamp(e))).

[0055] In one embodiment, the determination function f may be such that Tdose(e) = Tcustomer - (T RTC_ transmission - T 时间戳 (e)).

[0056] In one embodiment, the time information of the recording unit may include the time information T RTC_m associated with the transmission of the recording unit, which indicates the first time point m at which at least a first portion of the dose event record has been transmitted for reception by the receiving unit. If such a transmission of at least the first portion of the dose event record has not occurred previously, T RTC_m may be set to the default value of T RTC . For example, T RTC_m may be set to zero.

[0057] In one embodiment, the time information of the recording unit may include the transmission-related time information T of the recording unit RTC_m+1 , which indicates the second time point m+1 at which at least a second part of the dose event record is transmitted for reception by the receiving unit. In one embodiment, the determination period may be between T RTC_m and T RTC_m+1 .

[0058] In one embodiment, the time information from the receiving unit may include the time information T of the receiving unit 客户_p , which indicates the third time point p at which the first part of the dose event record has been received by the receiving unit. The third time point may be earlier than the second time point.

[0059] In one embodiment, the time information from the receiving unit may include the time information T of the receiving unit 客户_p+1 , which indicates the fourth time point p+1 at which the second part of the dose event record is received by the receiving unit. If at the third time point the receiving unit has not received any part of the dose event record, the mentioned second part of the dose event record may be the at least one part of the dose event record as described above.

[0060] In one embodiment, the determination function for a particular dose event may be selectable from or selected from a plurality of different determination functions, depending on the occurrence of irregularities in the time information of the at least one part of the dose event record during the determination period.

[0061] In one embodiment, if the determination period does not contain any irregularities, the determination function g may be selected. Similarly, if after the last reset of T RTC during the determination period the dose event to be determined is recorded 剂量 (e), then g may be selected. In this context, the last reset of T RTC may be such a reset of T RTC during the determination period that there is no subsequent reset of T RTC thereafter during the determination period. In other words, if there is no reset event between the last reset of T RTC and the time point at which the at least one part of the dose event record is transmitted for reception by the receiving unit.

[0062] In one embodiment, if the determination period starts with a reset of T RTC , the determination function g may be selected.

[0063] In one embodiment, if the determination period starts after time p at which at least a portion of the dose event record has been received by the receiving unit, and if T is reset for the first time within the determination period RTC before T 剂量 (e) of the dose event e to be determined is recorded, then the determination function h may be selected.

[0064] In one embodiment, if neither of the two conditions for selecting g or h is satisfied, then the determination function i may be selected. For example, if T is reset for the nth time and the (n + 1)th time within the determination period RTC and T RTC is recorded between them 剂量 (e) of the dose event e to be determined, then i may be selected, where n ≥ 1.

[0065] The determination function i may be a function of T 时间戳 (e), T 用户 (e 其他 ) and T 时间戳 (e 其他 ).

[0066] T 时间戳 (e) may be the time information related to the dose event of the recording unit, which indicates the time when the dose event e is recorded in the dose event record, as described above.

[0067] T 用户 (e 其他 ) may be the user - typed time of another dose event e 其他 , and this other dose event is recorded in the same part of the determination period as the dose event e for which T 剂量 (e) is to be determined. In this context, "the same part" means that there is no irregularity or reset of T 其他 between the dose event e and the dose event e RTC . For example, if T is reset for the nth time and the (n + 1)th time within the determination period RTC and T RTC is recorded between them 剂量 (e) of the dose event e to be determined, where n ≥ 1, then another dose event e 其他 must also be recorded between the nth reset event and the (n + 1)th reset event within the determination period.

[0068] T 时间戳 (e 其他 ) may be the time information related to the dose event of the recording unit, which indicates the time when another dose event e 其他 is recorded in the dose event record.

[0069] In one embodiment, the determination functions g, h, and i can be different determination functions.

[0070] In one embodiment, at least two of the determination functions g, h, and i can be equal determination functions.

[0071] The absolute time T of a specific dose event e recorded in the dose event record can be determined according to one of the following determination functions 剂量 (e):

[0072] T dose(e) = g(T customer - (T RTC_ transmission - T timestamp(e))), and / or

[0073] T 剂量 (e) = h(Δ 目前的 + T 时间戳 (e)), and / or

[0074] T 剂量 (e) = i(T 用户 (e 其他 ) - T 时间戳 (e 其他 ) + T 时间戳 (e)).

[0075] In one embodiment, the determination functions g, h, and i can be functions of the variables and / or expressions specified in the parentheses.

[0076] In one embodiment, according to the determination function g:

[0077] T dose(e) = T customer - (T RTC_ transmission - T timestamp(e)).

[0078] In one embodiment, according to the determination function h:

[0079] T 剂量 (e) = Δ 目前的 + T 时间戳 (e).

[0080] In one embodiment, according to the determination function i:

[0081] T 剂量 (e) = T 用户 (e 其他 ) - T 时间戳 (e 其他 ) + T 时间戳 (e).

[0082] In one embodiment, if T is recorded between the first dose event recorded in the dose event record and the first irregularity in the determination period剂量 (e) For the dose event to be determined, the determination function j can be selected. In other words, referring to the first dose event recorded in the dose event record, it should be understood that if the determination period starts with the first dose event recorded in the dose event record, the determination function j can be selected.

[0083] In one embodiment, if there is no reset of T during the determination period RTC the determination function k can be selected.

[0084] In one embodiment, if the determination period starts after an earlier time point p at which at least one part of the dose event record has been successfully received by the receiving unit, and further if T RTC is not at its default value at the start of the determination period, and further if T is reset for the first time during the determination period RTC before which T 剂量 (e) the dose event e to be determined, the determination function l can be selected. The first reset of T RTC is such a reset of T during the determination period that RTC there has been no previous reset of T during the determination period RTC before that.

[0085] In one embodiment, the determination functions g, j, k, and l can be different determination functions.

[0086] In one embodiment, at least two of the determination functions g, j, k, and l can be equal determination functions.

[0087] In one embodiment, one, any selected multiple, or all of the following can be determined by absolute time (e.g., Coordinated Universal Time UTC): T RTC , T RTC_FDE , T RTC_ transmission, T RTC_m , T RTC_m+1 , T 时间戳 (e), T 时间戳 (e 其他 ), T 用户 (e 其他 ), T 客户 , T 客户_p and T 客户_p+1 .

[0088] In one embodiment, the T 客户 , T 客户_p and T 客户_p+1 of the receiving unit can indicate the time point at which at least one part of the dose event record has been received by the receiving unit.

[0089] In one embodiment, one, any selected combination, or all of the following may be time information in a format that is not directly readable by a human (e.g., UNIX time (EPOCH time)): T RTC , T RTC_FDE , T RTC_ transmission, T RTC_m , T RTC_m+1 , T timestamp(e), T timestamp(e other), T 用户 (e 其他 ), T 客户 , T 客户_p and T 客户_p+1 .

[0090] In one embodiment, in view of irregularities in the dose event record and / or previous transmissions of at least a portion of the dose event record to be received by the receiving unit, all time information that is not in a format directly readable by a human can be converted into time information that is directly readable by a human, such as UTC.

[0091] In one embodiment, the absolute time T 剂量 (e) of a dose event can be determined based on a determination function that converts the time information T 时间戳 (e) associated with the dose event into a format directly readable by a human, such as UTC or any other time format suitable for precisely indicating the time of the dose event, such that it can be understood by a human without further conversion.

[0092] In one embodiment, the absolute time T 剂量 (e) of a specific dose event e recorded in the dose event record can be determined according to one of the following determination functions:

[0093] T dose(e) = g(T client - (T RTC_ transmission - T timestamp(e))), and / or

[0094] T 剂量 (e) = j(T RTC_FDE + T 时间戳 (e)), and / or

[0095] T 剂量 (e) = k(T 客户_p+1 - (T RTC_m+1 - T 时间戳 (e)) * CF), and / or

[0096] T 剂量 (e) = l(T 客户_p - (T RTC_m - T 时间戳 (e))),

[0097] In one embodiment, the determination functions g, j, k, and l can be functions of the variables and / or expressions specified in parentheses.

[0098] In one embodiment, according to the determination function g,

[0099] T dose(e) = T customer - (T RTC_ transmission - T timestamp(e)).

[0100] In one embodiment, according to the determination function j:

[0101] T 剂量 (e) = T RTC_FDE + T 时间戳 (e).

[0102] In one embodiment, according to the determination function k:

[0103] T 剂量 (e) = T 客户_p+1 - (T RTC_m+1 - T 时间戳 (e)) * CF.

[0104] In the determination function k, CF is a correction factor. The correction factor can be a function of the time information from the recording unit and the time information from the receiving unit. The correction factor can be configured to compensate for the time drift between the time information of the recording unit and the time information of the receiving unit. For example, the T RTC of the recording unit and the T 客户 indicating the absolute time (e.g., UTC) 客户_p or T 客户_p+1 ) time drift.

[0105] In one embodiment, the correction factor CF can be determined according to the following equation:

[0106]

[0107] In one embodiment, according to the determination function l:

[0108] T 剂量 (e) = T 客户_p - (T RTC_m - T 时间戳 (e)).

[0109] In one embodiment, before determining T 剂量 (e), the method can include the following steps: transmitting the at least one part of the dose event record from the recording unit to the receiving unit.

[0110] In one embodiment, the transmission can be a wireless transmission, such as a transmission via Bluetooth, Bluetooth Low Energy, Near Field Communication (NFC), or any other suitable wireless technology. Alternatively, the transmission can be a wired transmission, such as via Universal Serial Bus (USB).

[0111] In one embodiment, before transmitting the at least one portion of the dose event record, the method can include the step of: recording, with a recording unit, information related to one or more dose events in a dose event record.

[0112] Another aspect of the present disclosure relates to an apparatus for a medical device. The apparatus includes a recording unit, an energy source, and a storage unit. The recording unit is configured to record information related to one or more dose events performed with the medical device in a dose event record. The recording unit includes a timer configured to provide time information, which is T, to the recording unit. RTC The storage unit is configured to store the dose event record. The storage unit can form part of the recording unit. The energy source is configured to supply electrical energy to the recording unit and / or the storage unit.

[0113] In one embodiment, the apparatus can be configured to be attachable to a medical device. The medical device can be a medicament delivery device. The medicament delivery device can be a device that a user can use to set a variable dose (a so-called variable dose device). The medicament delivery device can be an injection device. The medicament delivery device can be a pen-type device.

[0114] The apparatus can be attachable to a dose setting unit, a dose setting mechanism, an activation mechanism, an ejection unit, and / or a housing of the medical device.

[0115] The apparatus can be configured to be attachable to the medical device such that a user can perform a dose event with the medical device via the apparatus.

[0116] The timer of the recording unit can include a real-time clock. The real-time clock can be synchronized with an absolute time (e.g., UTC) during the manufacture of the recording unit or during the assembly of some or all of the components of the apparatus. Specifically, the start value of T RTC can be set to the absolute time when the timer starts running (e.g., when the timer is connected to the energy source). Alternatively, the start value of T RTC can be any predefined value, such as zero or a value different from zero.

[0117] In one embodiment, the value of T RTC at the moment when the first dose event is recorded in the dose event record can be stored as T RTC_FDE . In one embodiment, the value of T at the moment when the first dose event is recorded in the dose event record may not be storedRTC value

[0118] In one embodiment, T may be set to zero after at least a portion of the dose event record has been transmitted for reception by the receiving unit and / or after the transmitted portion has been received by the receiving unit. In one embodiment, T may be set to zero each time a portion of the dose event record has been transmitted for reception by the receiving unit and / or after the transmitted portion of the dose event record has been received by the receiving unit. RTC In one embodiment, T may be set to zero after at least a portion of the dose event record has been transmitted for reception by the receiving unit and / or after the transmitted portion has been received by the receiving unit. In one embodiment, T may be set to zero each time a portion of the dose event record has been transmitted for reception by the receiving unit and / or after the transmitted portion of the dose event record has been received by the receiving unit. RTC set to zero.

[0119] The time information T RTC may be in a format that can be read intuitively by a person, such as, for example, Coordinated Universal Time (UTC). Alternatively, T RTC may be in a format that cannot be read intuitively by a person, such as UNIX time (EPOCH time).

[0120] The time information from the recording unit may include one, any selected plurality, or all of the following: T timestamp (e), T RTC_ transmission, T RTC_m , T RTC_m+1 and T RTC_FDE , where T timestamp (e), T RTC_ transmission, T RTC_m , T RTC_m+1 and T RTC_FDE are the time information of the recording unit as described in the foregoing.

[0121] The time information from the receiving unit may include one or all of the following: T 客户 , T 客户_p and T 客户_p+1 , where T 客户 , T 客户_p and T 客户_p+1 are the time information of the receiving unit as described in the foregoing.

[0122] In one embodiment, the index m may be incremented by one each time a portion of the dose event record is transmitted for reception by the receiving unit. Similarly, the index p may be incremented by one each time a portion of the dose event record is successfully received by the receiving unit.

[0123] In one embodiment, the receiving unit may be part of a dose event processing device.

[0124] In one embodiment, at the moment T when the first dose event record is in the dose event record RTC the value of may be used as T RTC_FDEStored in a storage unit. In one embodiment, it may not be stored at time T when a first dose event is recorded in the dose event record RTC value.

[0125] In one embodiment, the device is or forms part of an add-on. For example, the device can be an add-on that includes an electronic button. The device can be configured to be attached to or attachable to a medical device. The device can be attachable to a medicament delivery device (e.g., a device as further described above).

[0126] Another aspect of the present disclosure relates to a medical device that includes a device, a dose setting unit, and a dose ejection unit.

[0127] The medical device can be a medicament delivery device, such as a device as further described above.

[0128] The dose setting unit can be operatively connected to the dose ejection unit such that a dose set by the dose setting unit can be ejected by the dose ejection unit.

[0129] The device can be configured to record dose events performed with the medical device in a dose event record. The device can be releasably attached to the medical device. Alternatively, the device can be fixedly attached to the medical device. Alternatively, the device can be integrally formed with the medical device. The device can be the device as described in the foregoing paragraph.

[0130] The medical device can further include a holder for holding a medicament container and / or a medicament container having a volume containing a medicament. The medicament container can further include a stopper configured to move within the volume to discharge the medicament from the medicament container when moved in the distal direction.

[0131] The dose ejection unit can include a drive unit and a plunger. The drive unit can be configured to provide a force for moving the plunger in an axial direction. The plunger can be configured to transfer the movement driven by the force of the drive unit to the stopper of the medicament container. If moved distally within the volume, the stopper can be configured to discharge the medicament from the medicament container.

[0132] In an embodiment, the plunger can be configured such that its distal end forms the stopper of the medicament container. In other words, the distal end of the plunger can be configured to move within the volume, whereby the medicament is discharged therefrom when moved in the distal direction.

[0133] In one embodiment, the drive unit can be a mechanism that transfers the user's force to the plunger.

[0134] In one embodiment, the drive unit can be a drive spring. Due to user interaction on the medical device (e.g., during dose setting or selection), the drive spring can be pre-tensioned or can be tensioned.

[0135] The medical device can further include a cap and / or a needle mount for mounting the needle unit to the device. The cap can be configured to fully or partially cover the needle when the cap is attached to the medical device and the needle unit is mounted.

[0136] Another aspect of the present disclosure relates to a dose event processing device for determining the absolute time T z of one or more recorded dose events e1 to e 剂量 (e) performed with a medical device, where e represents a particular dose event among the one or more dose events. The dose event processing device includes a receiving unit and a processing unit. The receiving unit is configured to receive at least a portion of the dose event record containing the one or more recorded dose events e1 to e z . The dose event processing device is configured to determine the absolute time T z of the one or more recorded dose events e1 to e 剂量 (e) recorded in the received portion of the dose event record.

[0137] In one embodiment, the dose event processing device can be configured to determine the absolute time T z of the one or more recorded dose events e1 to e 剂量 (e) based on a determination function. The determination function for a particular dose event e can be selected depending on the occurrence of irregularities in the time information of the received portion of the dose event record and / or taking into account the timestamp T 时间戳 (e) of the particular dose event e with respect to the irregularities in the dose event record, as explained in the previous paragraph.

[0138] In one embodiment, the determination function for a particular dose event e can additionally be selected depending on whether the determined period containing the particular dose event e starts with a reset of T RTC .

[0139] In one embodiment, the processing unit can be configured to execute a method according to an aspect of the present disclosure.

[0140] The dose event processing device can further include a user interface. The user interface can be operatively connected to the receiving unit and / or the processing unit. The user interface can be configured to receive user input, e.g., the user's selection of a determined period in the received portion of the dose event record.

[0141] The dose event processing device can be or can form part of a mobile device (e.g., a smart phone, a tablet computer, or a portable computer). Alternatively, the dose event processing device can be or can form part of a fixed processing device (e.g., a fixed computer or a server).

[0142] Another aspect of the present disclosure relates to a computer program product that includes machine-readable instructions that, when executed by a processing unit, cause a dose event processing device to implement a method for determining the absolute time T z of one or more recorded dose events e1 to e 剂量 (e) performed by a medical device. The dose event processing device can be a dose event processing device according to an aspect of the present disclosure. The method can be a method according to an aspect of the present disclosure.

[0143] Another aspect of the present disclosure relates to a computer-readable storage medium, such as a non-transitory computer-readable storage medium, on which a computer program product is stored. The computer program product includes machine-readable instructions that, when executed by a processing unit, cause a dose event processing device to implement a method for determining the absolute time T z of one or more recorded dose events e1 to e 剂量 (e) performed by a medical device. The computer program product can be a computer program product according to an aspect of the present disclosure.

[0144] In other words, an aspect of the present disclosure relates to a computer-readable storage medium, such as a non-transitory computer-readable storage medium, on which a computer program product is stored. The computer program product includes machine-readable instructions that, when executed by a processing unit of a dose event processing device, cause the dose event processing device to implement a method for determining the absolute time T z of one or more recorded dose events e1 to e 剂量 (e), where e represents a specific dose event, and where the index z is a positive integer.

[0145] In one embodiment, the method can be a method according to an aspect of the present disclosure.

[0146] In one embodiment, the dose event processing device can be a dose event processing device according to an aspect of the present disclosure.

[0147] The methods, devices, and equipment according to this disclosure offer the following advantages: The absolute times of one or more dose events performed with a medical device can be determined precisely and reliably even if there is an interruption in the power supply of the recording unit that causes the timer of the recording unit to pause or reset, or if the recording unit is affected by electromagnetic interference.

[0148] In particular, in contrast to prior art methods, according to this disclosure, the T of dose events recorded before and after resetting the timer of the recording unit can be determined reliably. 剂量 (e). This is because, in each determination, the possible reset or pause of T is taken into account and compensated for. RTC of.

[0149] Furthermore, it is not necessary to store the First-Use-Time in the recording unit, which further makes the methods, devices, and equipment robust against loss of time information. Due to the use of time information from the recording unit as well as from the receiving unit, the drift of the timer of the recording unit compared to the absolute time can be compensated for.

[0150] It should be noted that all aspects described above by way of example can be combined with other aspects or parts thereof as described in the foregoing, even if such combinations of aspects and parts are not explicitly mentioned. BRIEF DESCRIPTION OF THE DRAWINGS

[0151] Figure 1 Schematically shows the steps of a method for determining the absolute time of a recorded dose event performed with a medical device according to an embodiment of this disclosure.

[0152] Figure 2 Is a diagram showing dose events and corresponding time information of a recording unit and a receiving unit, wherein, in the shown determination period, there are no irregularities in the time information recorded for the dose events.

[0153] Figure 3 Is a diagram showing dose events and corresponding time information of a recording unit and a receiving unit, wherein, in the shown determination period, there is one irregularity in the time information recorded for the dose events.

[0154] Figure 4 Is a diagram showing dose events and corresponding time information of a recording unit and a receiving unit, wherein, in the shown diagram, there are two different determination periods, wherein there are no irregularities in the time information recorded for the dose events.

[0155] Figure 5It is a diagram showing dose events and corresponding time information of a recording unit and a receiving unit. Among them, in the shown diagram, there are two different determination periods, and the second determination period contains an irregularity in the time information of the dose event record.

[0156] Figure 6 It is a diagram showing dose events and corresponding time information of a recording unit and a receiving unit. Among them, in the shown diagram, there are two different determination periods, and the second determination period contains two irregularities in the time information of the dose event record.

[0157] Figure 7 Schematically shows a device for a medical device according to an embodiment of the present disclosure.

[0158] Figure 8 Schematically shows a dose event processing device according to an embodiment of the present disclosure.

[0159] Figure 9 Schematically shows a medical device according to an embodiment of the present disclosure. Detailed implementation

[0160] In the drawings, the same elements, the same kind of elements, and the elements with the same or similar functions may have the same reference numerals.

[0161] As outlined above, the object of the present disclosure is to provide improvements related to determining the absolute time of recorded dose events, especially if the real-time clock has been reset before recording the dose event. A further object of the present disclosure is to eliminate the need to store the time of the first dose event performed by the medical device.

[0162] Figure 1 Exemplarily shows the steps of a method for determining the absolute time T z of one or more recorded dose events e1 to e 剂量 (e) performed by a medical device. In this context, e represents a specific dose event among the dose events e1 to e z recorded in the dose event record. The method starts with the following step S100: receiving at least a part of the dose event record containing at least one dose event e by the receiving unit 71 (see Figure 8 ).

[0163] According to the method, T Figure 7 (e) is determined based on at least one time information from the recording unit 11 (see 剂量 ) and at least one time information from the receiving unit 71, and the recording unit records the dose event for the dose event record.

[0164] This at least one portion of the dose event record may include information related to at least one, any selected plurality, or all of the following: a unique dose event identifier, a dose amount, and time information T of the recording unit 11 related to the dose event 时间戳 (e), this time information indicates the time at which the dose event e is recorded in this at least one portion of the dose event record.

[0165] The dose event identifier may be a unique combination of numbers, text, or symbols based on which a specific dose event e can be uniquely identified. The dose amount may be the amount or dosage of the medicament set, selected, or output in a single dose event e.

[0166] The time information from the recording unit 11 may include one, any selected plurality, or all of the following: T timestamp (e), T RTC_ transmission and T RTC_FDE . T timestamp (e) may be the time information of the recording unit 11 related to the dose event, which indicates the time at which the dose event e is recorded in the dose event record. T RTC_ Transmission may be the time information of the recording unit 11 related to the transmission, which indicates the time at which the at least one portion of the dose event record containing the dose event e is transmitted for reception by the receiving unit 71. T RTC_FDE may be the first dose event time information of the recording unit, which indicates the time at which the first dose event is recorded in the dose event record by the recording unit 11.

[0167] The time information from the receiving unit 71 may include the time T of the receiving unit 71 客户 , this time indicates the time at which the at least one portion of the dose event record is received by the receiving unit 71. In one embodiment, the time information of the receiving unit 71 may be synchronized with an absolute time (e.g., Coordinated Universal Time UTC).

[0168] The recording unit 11 includes a timer (not shown), which is configured to provide time information for the recording unit 11, and this time information is T RTC . The timer of the recording unit 11 may include a real-time clock. T RTC The start value of can be set to the absolute time corresponding to the moment when the timer starts running (e.g., when the recording unit is connected to the energy source during assembly).

[0169] In one embodiment, at the moment T when the first dose event is recorded in the dose event record RTC the value of can be stored as T RTC_FDE .

[0170] In one embodiment, when a first dose event is recorded in the dose event record, the value of T RTC is set to zero. In one embodiment, T RTC can be set to zero after at least a portion of the dose event record has been transmitted for reception by the receiving unit 71 and / or after the transmitted portion has been received by the receiving unit 71. In one embodiment, T RTC can be set to zero each time a portion of the dose event record has been transmitted for reception by the receiving unit and / or after the transmitted portion of the dose event record has been received by the receiving unit 71.

[0171] After the at least one portion of the dose event record has been received by the receiving unit 71, in step S101, a determination period in the received portion of the dose event record is defined.

[0172] The determination period is a part of the received portion of the dose event record that contains all dose events e i to e k for which the absolute time T 剂量 (e) is to be determined. For example, the determination period can be defined based on the unique dose event identifiers of the dose events (for which T 剂量 (e) has not yet been determined) in the received portion of the dose event record. Alternatively, the determination period can be selected by the user, for example via a user interface 73 (see Figure 8 ) operatively connected to the receiving unit 71. Alternatively, the determination period can extend over the entire length of the received portion of the dose event record.

[0173] The dose event identifier can be a unique combination of numbers, text, or symbols based on which a specific dose event can be uniquely identified. In addition to the unique dose event identifier, the dose record also includes information about the dose amount of each dose and the time information T 时间戳 (e) of the recording unit related to the dose event, which indicates the time at which the dose event e was recorded in the dose event record. The dose amount can be the amount or dosage of the medicament set, selected, or output in a single dose event.

[0174] According to step S102, the time information in the dose event record included in the determination period is evaluated for the occurrence of irregularities.

[0175] The evaluation can be based on the time information from the recording unit 11 and / or on the information stored in the dose event record and / or on the time information from the receiving unit 71.

[0176] In one embodiment, the occurrence of an irregularity is evaluated based on the detection of a change (e.g., a step change) in a variable Δ that indicates the time deviation between the recording unit 11 and the receiving unit 71. After at least a portion of the dose event record has been received by the receiving unit 71, Δ can be determined based on the time information from the recording unit 11 and the time information from the receiving unit 71 (e.g., T RTC_m and T 客户_p ). In one embodiment, T RTC_m is the transmission-related time information of the recording unit, which indicates the time m at which the at least one portion of the dose event record was transmitted for reception by the receiving unit, and T 客户_p is the time information from the receiving unit, which indicates the time p at which the at least one portion of the dose event record was received by the receiving unit. In one embodiment, Δ can be determined according to the following equation: Δ = T 客户_p −T RTC_m .

[0177] In one embodiment, Δ is determined each time a portion of the dose event record is received by the receiving unit 71. Each determined value of Δ is stored as Δ current_i in a memory unit (not shown) for further processing at a later point in time. Alternatively, Δ can be determined less frequently, e.g., only every second, third, fourth, fifth, tenth, twentieth, or fiftieth time a portion of the dose event record is received by the receiving unit. In one embodiment, only the most recently determined Δ can be stored as Δ current in the recording unit 11.

[0178] In one embodiment, the change can be detected by comparing the most recent value of Δ with one of the stored Δ current_i or the stored Δ current.

[0179] The irregularity can be a reset event of the recording unit 11, at which the timer of the recording unit 11 is reset, such that T RTC changes to the default value of T RTC . In one embodiment, the default value is zero. Alternatively, the default value can be different from zero.

[0180] In step S103, based on the evaluation result of the irregularity in the time information of the dose event record, a determination function for determining T i to e k for each dose event e 剂量 (e) is selected. Further, the determination function is selected taking into account the time stamp T 时间戳 (e) of the dose event e with respect to the irregularity in the dose event record. In one embodiment, the time T RTCSelect a determination function based on the value.

[0181] In step S104, based on the determination function selected in step S103, determine the absolute time T i to e k for each dosing event e 剂量 (e) during the determination period.

[0182] In one embodiment, before determining T 剂量 (e), the method may include step S90, that is, transferring at least one part of the dosing event record from the recording unit 11 to the receiving unit 71. In one embodiment, before the transfer S90, the method may include step S80, that is, recording, using the recording unit 71, information related to one or more dosing events e1 to e z performed by the medical device in the dosing event record.

[0183] The determination function f may be a function of the time information from the recording unit and the time information from the receiving unit.

[0184] In one embodiment, the determination function f may be such that Tdose(e) = f(Tcustomer, T RTC_ transmission, T 时间戳 (e)).

[0185] In one embodiment, the determination function f may be a function of the difference between the time information from the receiving unit and different time information from the recording unit (for example, T RTC_ transmission - Ttimestamp(e)), such that Tdose(e) = f(Tcustomer, (T RTC_ transmission - Ttimestamp(e))).

[0186] In one embodiment, the determination function f may be a function of the difference between the time information from the receiving unit and the time information from the recording unit, such that Tdose(e) = f(Tcustomer - (T RTC_ transmission - T 时间戳 (e))).

[0187] In one embodiment, the determination function f may be such that Tdose(e) = Tcustomer - (T RTC_ transmission - T 时间戳 (e)).

[0188] In one embodiment, if the determination period does not contain any irregularities, the determination function g(S103) may be selected. This is exemplarily shown by Figure 2 the curve of. The x-axis of the figure represents the absolute time with which the receiving unit is synchronized, such as UTC. The y-axis of the figure represents T RTCvalue. The vertical dashed line indicates the T of the receiving unit 71 when at least a portion of the dose event record is received by the receiving unit 71 客户 / T 客户_p (indicated by the label "BLE Sync (BLE synchronization)"). The crosses on the curve represent dose events e i to e k for which T 剂量 (e) shall be determined. In Figure 2 , that portion of the dose event record starting with "First Use" up to "Today" may be transmitted for reception by the receiving unit. The determination period may extend between "First Use" and "Today".

[0189] In one embodiment, if T RTC is recorded after the last reset of T 剂量 (e) in the determination period for which the dose event is to be determined, then g(S103) may also be selected. In this context, the last reset of T RTC in the determination period is such a reset of T RTC that there is no subsequent reset of T RTC in the determination period thereafter. In other words, if there is no reset event between the last reset of T RTC and the time point when at least a portion of the dose event record is transmitted for reception by the receiving unit 71

[0190] Reference Figure 3 , this is the right portion of the shown curve from after the reset of T RTC (indicated by the text description "ESD / Drop (ESD / drop)") (i.e., when T RTC = 0) until the vertical dashed line indicated by the text description "BLE Sync (BLE synchronization)" (i.e., when the first portion of the dose event record is received by the receiving unit 71). In Figure 3 , the determination period extends from "First Use" until "Today".

[0191] To reference certain portions of the curve, the determination period may be divided into two parts, one part being the portion before the reset of T RTC (i.e., the left portion of the curve), and the other part being the portion after the reset of T RTC (i.e., the right portion of the curve).

[0192] Since "BLE Sync (BLE synchronization)" is the first transmission of the dose event record, it is obvious that there is no stored information available for determining the change in the variable Δ and for determining T RTCReset of Δ current. In this scenario, a determination of the presence of T in a determined time period can be made based on information stored in the dose event record (e.g., T 时间戳 (e)) in combination with the dose event identifier. If the T RTC of a subsequent dose event does not increase, this indicates a reset of T 时间戳 between these dose events. RTC

[0193] For all dose events in the second part (i.e., the right part of the curve), the determination function g is selected.

[0194] The determination function g is a function of the time information from the recording unit 11 and the time information from the receiving unit 71, such that T dose(e) = g(T customer, T RTC_ transmission, T timestamp(e)). More particularly, the determination function g can be a function of the difference between the time information from the receiving unit 71 and the time information from the recording unit 11 (e.g., T RTC_ transmission - T timestamp(e)), such that T dose(e) = g(T customer, (T RTC_ transmission - T timestamp(e))). Even more particularly, the determination function g can be a function of the difference between the time information from the receiving unit 71 and the time information from the recording unit 11 (e.g., T RTC_ transmission - T timestamp(e)), such that T dose(e) = g(T customer - (T RTC_ transmission - T 时间戳 (e))). In one embodiment, the determination function g is such that:

[0195] T dose(e) = T customer - (T RTC_ transmission - T timestamp(e)).

[0196] Regarding the dose event e Figure 3 shown by the cross on the left part of the curve in 左 , the condition for selecting the determination function g is not satisfied because there is a reset of T 左 between e RTC and the end of the determined time period. In other words, the absolute time T 左 of this dose event e 剂量 (e 左 ) cannot be reliably determined using the determination function g.

[0197] However, in one embodiment, for the dose event e 左 and all other recorded dose events in the first part, the determination function i can be selected.

[0198] The determination function i is T时间戳 (e) T 用户 (e 其他 ) and T 时间戳 (e 其他 ). As described above, T 时间戳 (e) is the time information related to the dose event of the recording unit, which indicates the time when the absolute time is recorded in the dose event record for the dose event e to be determined. 用户 (e 其他 ) is another dose event e 其他 The user enters a time for another dose event at T 剂量 (e) recording the dose event e for which the determination is being made in the same part of the determination period. In this context, “same part” means that in the dose event record, dose event e is recorded as being in the same part as dose event e. 其他 (See e.g. Figure 6 There is no irregularity or effect on T between the two dose events between the two "ESD / Drop" markers. RTC Reset. 时间戳 (e 其他 ) is the time information related to the dose event of the recording unit 11, which indicates this other dose event e 其他 The time recorded in the dose event record.

[0199] In one embodiment, the determination function i is T 用户 (e 其他 ) and dose events e and e 其他 The function of the difference between the time information associated with the dose event, such that:

[0200] T 剂量 (e) = T 用户 (e 其他 )-T 时间戳 (e 其他 )+T 时间戳 (e)

[0201] In such Figure 5 In one embodiment shown in , the determination period extends between an earlier time point m, at which at least one portion of the dose event record is transmitted for reception by the receiving unit 71, and a later time point m+1, at which another portion of the dose event record is transmitted for reception by the receiving unit 71. The corresponding time information of the receiving unit 71 receiving these portions of the dose event record is given by the indexes p and p+1, respectively. In detail, T 客户_p is the time of the receiving unit 71, which indicates the time when the at least one part of the dose event record is received by the receiving unit 71 (see Figure 5the left "BLE Sync" mark in). Accordingly, T 客户_p+1 is the time of the receiving unit 71, which indicates the time when another part of the dose event record is received by the receiving unit 71 (see Figure 5 the right "BLE Sync" mark in).

[0202] Figure 5 the determined period shown in includes a reset of T RTC is further, in the curve shown, T RTC does not have its default value, such as zero, at the start of the determined period. However, to determine T 剂量 (e), T RTC may also have its default value at the start of the determined period.

[0203] Regarding the dose events recorded after the reset of T RTC (indicated by the mark "ESD / Drop"), the conditions for selecting the determination function g are satisfied. Regarding the dose events recorded before the reset of T RTC , the conditions for selecting the determination function g are not satisfied. For these dose events, the determination function h is selected.

[0204] In other words, if the determined period starts after the time point p when at least a part of the dose event record has been received by the receiving unit 71, and if the first reset of T RTC is recorded before the dose event e for which T 剂量 (e) is to be determined, then the determination function h is selected. If these conditions are met, the determination function h can be selected even if T RTC does not have its default value at the start of the determined period.

[0205] In one embodiment, the determination function h is a function of Δ current and T timestamp (e), where Δ current is determined based on the time information from the recording unit (e.g., T RTC_m ) and the time information from the receiving unit (e.g., T 客户_p ). Referring to the curve shown in Figure 5 , Δ current can be determined according to the formula: Δ current = T customer _p - T RTC_m .

[0206] In one embodiment, the determination function h may correspond to the determination function l described below. The determination function h (or l) may be such that:

[0207] T 剂量 (e) = Δ 目前的 + T 时间戳(e) = T 客户_p -T RTC_m +T 时间戳 (e).

[0208] refer to Figure 6 ,and Figure 5 The difference is that the curve shown includes the T RTC In other words, there are two resets of T in a certain period of time. RTC As described above, regarding the first reset of T in a certain period of time, RTC For all previously recorded dose events, select the determination function h. For the last reset T in the determination period RTC After all dose events recorded, select the determination function g.

[0209] In one embodiment, if T is reset for the nth time during a certain period of time RTC and the (n+1)th reset T RTC T 剂量 (e) For the dose event e to be determined, a determination function i is selected. In the example shown, n=1. T is determined using the determination function i 剂量 (e) The dose event in question is Figure 6 In the example, the two crosses between the “ESD / Drop” label on the left and the “ESD / Drop” label on the right are shown. However, in one embodiment, a determination function i may be selected for all n≥1. According to the determination function i:

[0210] T 剂量 (e) = T 用户 (e 其他 )-T 时间戳 (e 其他 )+T 时间戳 (e)

[0211] In one embodiment, the determination function i may also be selected for all dose events that do not satisfy the conditions for selecting the determination function g or the determination function h. For example, if the determination period begins with the first dose event recorded in the dose event record (see Figure 3 The dose event "e 左 ”), this includes dose events recorded before the first irregularity in the determination period.

[0212] In one embodiment, if the first dose event recorded in the dose event record (e.g., Figure 3 The dose event "e 左 ”) and the first irregularity in the determination period are recorded as T 剂量(e) For the dose event to be determined, the determination function j can be selected. In one embodiment, according to the determination function j:

[0213] T 剂量 (e) = T RTC_FDE + T 时间戳 (e).

[0214] As described above in the Summary of the Invention, T RTC_FDE can be the first dose event time information of the recording unit, which indicates the time when the first dose event is recorded in the dose event record by the recording unit 11. As outlined in the Summary of the Invention, T RTC 's initial value can be set according to the absolute time (e.g., Coordinated Universal Time UTC) during the manufacture of the recording unit. That is, the initial value of T RTC can be set to correspond to the absolute time at the moment when the timer starts running (e.g., at the moment when the recording unit is connected to the energy source during assembly). Therefore, T RTC_FDE can correspond to the value of T RTC at the moment when the first dose event is recorded in the dose event record.

[0215] In Figure 4 one embodiment shown, if there is no reset of T RTC during the determination period, the determination function k can be selected. Especially if T RTC is not at its default value at the start of the determination period, the determination function k can be selected. This is demonstrated by the dose event between the two "BLE Sync (BLE synchronization)" markers in Figure 4 .

[0216] In one embodiment, according to the determination function k:

[0217] T 剂量 (e) = T 客户_p+1 -(T RTC_m+1 - T 时间戳 (e)) * CF

[0218] In the determination function k, CF is a correction factor. This correction factor is a function of the time information from the recording unit and the time information from the receiving unit. In one embodiment, the correction factor CF can be determined according to the following equation:

[0219]

[0220] As described above, T RTC_m is the transmission-related time information of the recording unit, which indicates the first time point m at which at least the first part of the dose event record has been transmitted for reception by the receiving unit. T RTC_m+1is time information related to transmission of the recording unit, which indicates a second time point m+1 at which at least a second part of the dose event record is transmitted for reception by the receiving unit. T 客户_p is time information of the receiving unit, which indicates a third time point p at which a first part of the dose event record has been received by the receiving unit (see Figure 4 the left "BLE Sync" mark in). In one embodiment, the third time point may be earlier than the second time point, which is not shown but will be slightly Figure 4 before the right "BLE Sync" mark in. T 客户_p+1 is time information of the receiving unit, which indicates a fourth time point p+1 at which a second part of the dose event record is received by the receiving unit (see Figure 4 the right "BLE Sync" mark in).

[0221] Figure 7 Schematically shows a device 10 for a medical device according to an embodiment of the present disclosure. The device 10 includes a recording unit 11, a storage unit 12, an energy source 13, and a transmission unit 14. The recording unit is configured to record information related to one or more dose events performed with the medical device in a dose event record.

[0222] The recording unit 11 includes a timer, which is configured to provide time information for the recording unit, and the time information is T RTC . The storage unit 12 is configured to store the dose event record. The storage unit 12 may form part of the recording unit. The energy source 13 is configured to supply electrical energy to the recording unit 11 and / or the storage unit 12 and / or the transmission unit 14.

[0223] In one embodiment, the device 10 is configured to be attachable to a medical device 60 (e.g., a medicament delivery device as Figure 9 shown). As shown, the device 10 is configured to be attachable to the dose setting unit 20 of the medical device 60 such that a user can perform dose events with the medical device 60 via the device 10.

[0224] In one embodiment, the device 10 may be attachable to one or more of a dose setting unit, an activation mechanism, a dispensing unit, and / or a housing of the medical device.

[0225] As Figures 2 to 6 shown, in one embodiment, the value of T RTC may be set to a default value, i.e., zero, when the first dose event is recorded in the dose event record. Alternatively, the default value of T RTC may be different from zero, as described in the above Summary of the Invention.

[0226] The transmission unit 14 is configured to transmit the at least one portion of the dose event record and the time information T related to the transmission RTC_ for transmission to the receiving unit 71. The time information related to the transmission indicates the time at which the at least one portion of the dose event record containing the dose event e is transmitted for reception by the receiving unit 71. The receiving unit 71 can be part of the dose event processing device 70 (see Figure 8 ).

[0227] Figure 8 Schematically shows a dose event processing device 70 according to an embodiment of the present disclosure. The dose event processing device is configured to determine the absolute time T z of one or more recorded dose events e1 to e 剂量 executed by a medical device, where e characterizes a particular one of the one or more dose events e1 to e z in these dose events are recorded in the dose event record.

[0228] The dose event processing device 70 includes a receiving unit 71 and a processing unit 72. The receiving unit is configured to receive at least a portion of the dose event record containing the one or more recorded dose events e1 to e z The dose event processing device 70 (more specifically, its processing unit 72) is configured to determine the absolute time T z of the one or more recorded dose events e1 to e 剂量 recorded in the received portion of the dose event record.

[0229] In one embodiment, the dose event processing device 70 (more specifically, its processing unit 72) is configured to perform the method according to one and / or more of the foregoing paragraphs of the invention content.

[0230] The dose event processing device 70 further includes a user interface 73, which is operatively connected to the receiving unit 71 and the processing unit 72. The user interface 73 is configured to receive user input. Among other things, the user input can be a selection of a determined period in the received portion of the dose event record.

[0231] In one embodiment, the dose event processing device 70 can be a mobile device, such as a smart phone.

[0232] The dose event processing device 70 is configured to determine the absolute time T z of the one or more recorded dose events e1 to e 剂量 (e) based on a determination function. Depending on the occurrence of irregularities in the time information of the received portion of the dose event record (e.g., T RTCReset) and considering a specific dosing event e and the timestamp T of the irregularity in the dosing event record 时间戳 (e), to select a determination function for the specific dosing event e, as explained in the foregoing paragraphs and the above Summary of the Invention.

[0233] In one embodiment, if the determination period does not contain any irregularities, or if the last reset of T in the determination period RTC is followed by the recording of T 剂量 (e) for the dosing event for which the determination is to be made, then the determination function g is selected, where the last reset of T RTC is such a reset of T in the determination period that there is no subsequent reset of T RTC in the determination period thereafter. RTC

[0234] The occurrence of an irregularity is evaluated based on the detection of a change in the variable Δ, as explained in the foregoing paragraphs and the above Summary of the Invention. Alternatively or additionally, the occurrence of an irregularity can be evaluated based on the value of T 时间戳 (e) of a subsequent dosing event, as explained in the foregoing paragraphs and the above Summary of the Invention.

[0235] Alternatively or additionally, if the determination period contains one or more resets of T RTC , if the determination period starts after the time point p at which at least a part of the dosing event record has been received by the receiving unit 71, and if T RTC is recorded before the first reset of T 剂量 (e) for the dosing event for which the determination is to be made, then the determination function h is selected.

[0236] Alternatively or additionally, if neither of the two conditions for selecting g or h is satisfied, then the determination function i is selected. For example, if T RTC is recorded between the nth reset of T RTC and the (n + 1)th reset of T 剂量 (e) for the dosing event e for which the determination is to be made, where n ≥ 1, then i can be selected.

[0237] In one embodiment, these determination functions can be such that:

[0238] T dose(e) = g(T customer - (T RTC_ transmission - T timestamp(e))), and / or

[0239] T 剂量 (e) = h(Δ 目前的 + T 时间戳 (e)), and / or ​

[0240] T 剂量 (e) = i(T 用户 (e 其他 ) - T 时间戳 (e 其他 ) + T 时间戳 (e)),

[0241] wherein,

[0242] a) T 时间戳 (e) is the time information related to the dose event of the recording unit 11, which indicates the time when the dose event e is recorded in the dose event record;

[0243] b) T RTC_ transmission is the time information related to the transmission of the recording unit 11, which indicates the time when at least one part of the dose event record is transmitted for reception by the receiving unit 71;

[0244] c) T RTC_m is the time information related to the transmission of the recording unit 11, which indicates the time m when at least one part of the dose event record is transmitted for reception by the receiving unit 71;

[0245] d) T 客户 is the time information from the receiving unit 71, which indicates the time when at least one part of the dose event record is received by the receiving unit 71;

[0246] e) T 客户_p is the time information from the receiving unit 71, which indicates the time p when at least one part of the dose event record is received by the receiving unit 71;

[0247] f) Δ 目前的 is a variable indicating the time deviation between the recording unit 11 and the receiving unit 71, which is determined based on the time information from the recording unit 11 and the time information from the receiving unit 71, for example, based on T RTC_m and T 客户_p ;

[0248] g) T 用户 (e 其他 ) is the user - typed time of another dose event e 其他 which is in the same part of the determined period as the dose event e recorded in the dose event record;

[0249] h) T 时间戳 (e 其他 ) is the time information related to the dose event of the recording unit 11, which indicates the time when another dose event e 其他 is recorded in the dose event record; and

[0250] In one embodiment, g, h, and i are functions of the variables and / or expressions specified in parentheses.

[0251] In one embodiment, these determining functions can be such that:

[0252] T dose(e) = g(T customer - (T RTC_ transmission - T timestamp(e))), and / or

[0253] T 剂量 (e) = j(T RTC_FDE + T 时间戳 (e)), and / or

[0254] T 剂量 (e) = k(T 客户_p+1 - (T RTC_m+1 - T 时间戳 (e)) * CF), and / or

[0255] T 剂量 (e) = l(T 客户_p - (T RTC_m - T 时间戳 (e))),

[0256] wherein,

[0257] a) T 时间戳 (e) is the time information related to the dose event of the recording unit 11, which indicates the time when the dose event e is recorded in the dose event record;

[0258] b) T RTC_ transmission is the time information related to the transmission of the recording unit 11, which indicates the time when at least one part of the dose event record is transmitted for reception by the receiving unit 71;

[0259] c) T RTC_m is the time information related to the transmission of the recording unit 11, which indicates the first time point m when at least one part of the dose event record is transmitted for reception by the receiving unit 71;

[0260] d) T RTC_FDE is the first dose event time information of the recording unit 11, which indicates the time when the first dose event is recorded in the dose event record;

[0261] e) T RTC_m+1 is the time information related to the transmission of the recording unit 11, which indicates the second time point m + 1 when at least a second part of the dose event record is transmitted for reception by the receiving unit 71, and the second time point m + 1 is a time point after the first time point m when the first part of the dose event record has been transmitted for reception by the receiving unit;

[0262] f) T 客户 is time information from the receiving unit 71, which indicates the time at which the receiving unit 71 received the at least one portion of the dose event record;

[0263] g) T 客户_p is time information from the receiving unit 71, which indicates the third time point p at which the receiving unit 71 received the at least one portion of the dose event record;

[0264] h) T 客户_p+1 is the time information of the receiving unit 71, which indicates the fourth time point p + 1 at which the second portion of the dose event record was received by the receiving unit 71, and the fourth time point p + 1 is a time point after the third time point p at which the first portion of the dose event record was received by the receiving unit;

[0265] i) CF is a correction factor, which is a function of the time information from the recording unit 11 and the time information from the receiving unit 71, for example

[0266]

[0267] Figure 9 Schematically shows a medical device 60 according to an embodiment of the present disclosure. The shown medical device 60 is a medicament delivery device, which includes a device 10, a dose setting unit 20, and a dose ejection unit. The dose ejection unit is contained in a housing 30. The device 10 is releasably attached to the dose setting unit 20 of the medicament delivery device.

[0268] The dose setting unit 20 is configured to set the dose to be ejected during a dose setting operation. The dose setting unit 20 is operatively connected to the dose ejection unit such that the set dose can be ejected from the medicament delivery device during a dose ejection operation.

[0269] The device 10 is configured to record dose events performed with the medical device in a dose event record. The device 10 can be the device described in the foregoing paragraphs and / or the above summary of the invention.

[0270] The dose ejection unit includes a drive unit 31 and a plunger 32.

[0271] The medicament delivery device further includes a medicament container 40, which has a volume 42 containing the medicament, and a stopper 41, which can move within the volume 42 to discharge the medicament from the medicament container when moving in the distal direction.

[0272] The drive unit 31 is configured to provide a force for moving the plunger 32 in the axial direction. The plunger 32 is configured to transfer the movement driven by the force of the drive unit 31 to the stopper 41 of the medicament container 40, thereby moving the stopper 41 relative to the volume 42.

[0273] In an embodiment, the plunger 32 may be configured such that its distal end forms the stopper of the medicament container. In other words, the distal end of the plunger 32 may be configured to move within the volume, thereby discharging the medicament therefrom when moved in the distal direction.

[0274] In one embodiment, the drive unit may be a mechanism that transfers drive energy from the user to the plunger.

[0275] In one embodiment, the drive unit may be a drive spring. The drive spring may be pre-tensioned or may be tensioned due to user interaction on the medical device.

[0276] As Figure 9 shown, the medical device 60 may further include a needle 50 and a cap 51. The cap 51 may be configured to completely or partially cover the needle 50 when the cap 51 is attached to the medical device.

[0277] In one embodiment, the medical device may be a medicament delivery device. In one embodiment, the medicament delivery device may be a device (so-called variable dose device) that a user can set a variable dose with. In one embodiment, the medicament delivery device may be an injection device. In one embodiment, the medicament delivery device may be a pen-type device.

[0278] One embodiment of the present disclosure not shown in the drawings relates to a computer program product that includes machine-readable instructions that, when executed by a processing unit, cause a dose event processing device to implement a method for determining the absolute time T z of one or more recorded dose events e1 to e 剂量 (e) performed with a medical device. The dose event processing device may be a dose event processing device according to an embodiment or aspect of the present disclosure. The method may be a method according to an embodiment or aspect of the present disclosure.

[0279] One embodiment of the present disclosure not shown in the drawings relates to a computer-readable storage medium, such as a non-transitory computer-readable storage medium, on which a computer program product is stored, the computer program product including machine-readable instructions that, when executed by a processing unit, cause a dose event processing device to implement a method for determining the absolute time T z of one or more recorded dose events e1 to e 剂量The method of (e). The computer program product can be a computer program product according to an embodiment or aspect of the present disclosure.

[0280] An embodiment of the present disclosure not shown in the drawings relates to a computer-readable storage medium, such as a non-transitory computer-readable storage medium, on which a computer program product is stored. The computer program product includes machine-readable instructions that, when executed by a processing unit of a dose event processing device, cause the dose event processing device to implement a method for determining the absolute time T of one or more recorded dose events e1 to e z performed by a medical device 剂量 (e), where e represents a specific dose event and where the index z is a positive integer.

[0281] In one embodiment, the method can be a method according to an embodiment or aspect of the present disclosure.

[0282] In one embodiment, the dose event processing device can be a dose event processing device according to an embodiment or aspect of the present disclosure.

[0283] As mentioned in the Summary of the Invention, the terms "drug" or "pharmaceutical agent" are used synonymously herein and describe a pharmaceutical preparation that contains one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on a human or animal. In pharmacology, a drug or pharmaceutical agent is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. A drug or pharmaceutical agent can be used for a limited duration or regularly for a chronic disorder.

[0284] As described below, a drug or pharmaceutical agent can include at least one API or a combination thereof in various types of formulations for treating one or more diseases. Examples of APIs can include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). A mixture of one or more drugs is also contemplated.

[0285] A drug or medicament can be contained in a primary package or “drug container” suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a reservoir, or other rigid or flexible vessels configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. Storage can be at room temperature (e.g., about 20 °C) or refrigerated temperature (e.g., about -4 °C to about 4 °C). In some cases, the drug container can be or can include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), with one stored in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during dispensing into a human or animal body. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers) and allow mixing of the two components when needed by the user before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing when the components are dispensed into a human or animal body.

[0286] The drugs or medicaments contained in the drug delivery devices as described herein can be used for treating and / or preventing many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes (such as, diabetic retinopathy), thromboembolic disorders (such as, deep vein or pulmonary thromboembolism). Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following compendia: such as the Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)), and the Merck Index (15th edition).

[0287] Examples of APIs for treating and / or preventing type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or their analogs or derivatives; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms “analog” and “derivative” refer to a polypeptide having a molecular structure that can formally be derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues can be either encoded amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. In particular, the term “derivative” refers to a polypeptide having a molecular structure that can formally be derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), in which one or more organic substituents (e.g., fatty acids) are conjugated to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encoded amino acids), or amino acids (including non-encoded amino acids) have been added to the naturally occurring peptide.

[0288] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin lispro); Lys(B28), Pro(B29) human insulin (insulin aspart); Asp(B28) human insulin (insulin detemir); human insulin in which the proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala, and in which, in position B29, Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0289] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludec, ); B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0290] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide exenatide (Exendin-4, a 39-amino acid peptide produced by the salivary gland of the Gila monster), liraglutide semaglutide, taspoglutide, albiglutide dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tirzepatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN and glucagon-Xten.

[0291] Examples of oligonucleotides are, for example: mipomersen sodium A cholesterol-reducing antisense therapeutic agent for treating familial hypercholesterolemia or RG012 for treating Alport syndrome.

[0292] Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0293] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, gonadotropic hormone), somatropine (growth hormone), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0294] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., the polysulfated forms of the polysaccharides mentioned above), and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 It is a sodium hyaluronate.

[0295] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of the antigen-binding portion of an immunoglobulin molecule include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized antibodies or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies or single-chain antibodies. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the antibody has a reduced or no ability to bind to Fc receptors. For example, the antibody can be an isotype or subtype, an antibody fragment or a mutant that does not support binding to Fc receptors, e.g., its Fc receptor-binding region has been mutagenized or deleted. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins having a cross-over binding domain orientation (CODV).

[0296] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but still includes at least a portion of the full-length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can include a cleaved portion of the full-length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetra-specific, and multispecific antibodies (e.g., diabodies, triabodies, tetra-bodies)), monovalent or multivalent antibody fragments (e.g., divalent, trivalent, tetravalent, and multivalent antibodies), minibodies, chelated recombinant antibodies, triabodies or diabodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and antibodies comprising VHHs. Additional examples of antigen-binding antibody fragments are known in the art.

[0297] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the heavy chain polypeptide and the light chain polypeptide that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both the heavy chain polypeptide and the light chain polypeptide that are not CDR sequences and that are primarily responsible for maintaining the correct positioning of the CDR sequences to permit antigen binding. Although framework regions typically do not themselves directly participate in antigen binding as is known in the art, certain residues within the framework regions of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDRs to interact with the antigen.

[0298] Examples of antibodies are anti-PCSK-9 mAb (e.g., Alirocumab), anti-IL-6 mAb (e.g., Sarilumab), and anti-IL-4 mAb (e.g., Dupilumab).

[0299] Also contemplated are pharmaceutically acceptable salts of any of the APIs described herein for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0300] Those skilled in the art will understand that various components, formulations, devices, methods, systems, and embodiments of the APIs described herein can be modified (added to and / or removed) without departing from the full scope and spirit of the present invention, and the present invention encompasses such modifications and any and all equivalents thereof.

[0301] An exemplary drug delivery device may relate to a needle-based injection system as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly classified into multi-dose container systems and single-dose (partially or fully emptied) container systems. The container can be a replaceable container or an integral non-replaceable container.

[0302] As further described in ISO 11608-1:2014(E), a multi-dose container system may relate to a needle-based injection device having a replaceable container. In such a system, each container holds multiple doses, the sizes of which can be fixed or variable (predetermined by the user). Another multi-dose container system may relate to a needle-based injection device having an integral non-replaceable container. In such a system, each container holds multiple doses, the sizes of which can be fixed or variable (predetermined by the user).

[0303] As further described in ISO 11608-1:2014(E), a single-dose container system may relate to a needle-based injection device having a replaceable container. In one example of such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (fully emptied). In additional examples, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partially emptied). Also as described in ISO 11608-1:2014(E), a single-dose container system may relate to a needle-based injection device having an integral non-replaceable container. In one example of such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (fully emptied). In additional examples, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partially emptied).

[0304] It should be understood that all features and parts described in connection with the aspects in the Summary of the Invention can be used in the embodiments described in this section, even if not all those combinations are explicitly mentioned.

[0305] List of Reference Numerals

[0306] 10 Device

[0307] 11 Recording Unit

[0308] 12 Storage Unit

[0309] 13 Energy Source

[0310] 14 Transmission Unit

[0311] 20 Dose Setting Unit

[0312] 30 Housing

[0313] 31 Drive unit

[0314] 32 Plunger

[0315] 40 Medicament container

[0316] 41 Stopper

[0317] 42 Volume

[0318] 50 Needle

[0319] 51 Cap

[0320] 60 Medical device

[0321] 70 Dose event handling device

[0322] 71 Receiving unit

[0323] 72 Processing unit

[0324] 73 User interface

[0325] S80 Record the dose event in the dose event record

[0326] S90 Transmit the dose event record to the receiving unit

[0327] S100 Receive the dose event record

[0328] S101 Define a determination period

[0329] S102 Evaluate the time information of the dose event record in the determination period

[0330] S103 Select a determination function

[0331] S104 Determine the absolute time of the recorded dose event

Claims

1. A method for determining an absolute time or a standard time T of one or more recorded dose events (e1 to e z ) performed with a medical device, wherein, 剂量 (e), where e represents a specific dosing event; wherein, the one or more dosing events are recorded in a dosing event record; wherein, at least a portion of the dosing event record is received (S100) by a receiving unit (71) or is capable of being received by the receiving unit; and wherein T is determined (S104) based on at least one time information from the recording unit (11) and at least one time information from the receiving unit (71). 剂量 (e) the recording unit records the dosing event for the dosing event record.

2. The method according to claim 1, wherein, a) the time information from the recording unit (11) includes one, any selected plurality, or all of the following: The time information T related to the dosing event of the recording unit (11) 时间戳 (e), which indicates the time at which the dosing event (e) is recorded in the dosing event record; and The transmission-related time information T of the recording unit (11) RTC_传输 , which indicates the time at which the at least one part of the dose event record was transmitted for reception by the receiving unit (71), and / or wherein b) The time information from the receiving unit (71) includes the time T of the receiving unit (71), which indicates the time at which at least a portion of the dose event record was received by the receiving unit (71). 客户 ​ 3. The method according to any one of the preceding claims, wherein For each dose event, the at least one portion of the dose event record includes information related to at least one, any selected plurality, or all of the following: a unique dose event identifier, a dose amount, and a T of the recording unit (11) 时间戳 (e).

4. The method according to any one of the preceding claims, wherein, The recording unit includes a timer configured to provide time information T to the recording unit (11). RTC .

5. The method according to any one of the preceding claims, further comprising the following steps: Define (S101) a determination period in the at least one portion of the dose event record, where the determination period includes T 剂量 (e) One or more dose events (e i to e k ) to be determined, where k ≥ i ≥ 1, and where a determination function is used to determine the absolute time or standard time T i of a specific dose event (e k ) among the one or more dose events (e 剂量 to e ) within the determination period 6. The method according to claim 5, wherein the determination period is selectable by the user or is selected by the user, for example, via a user interface (73).

7. The method according to claim 5 or 6, further referring to claim 2, wherein, the determination function f is a function of the time information from the recording unit (11) and the time information from the receiving unit (71), such that: T 剂量 (e) = f(T 客户 , T RTC_传输 , T 时间戳 (e)), or such that T 剂量 (e) = f(T 客户 , (T RTC_传输 - T 时间戳 (e))), or such that T 剂量 (e) = f(T 客户 -(T RTC_传输 -T 时间戳 (e))), or such that T 剂量 (e) = T 客户 -(T RTC_传输 -T 时间戳 (e)).

8. The method according to any one of the preceding claims, further comprising the step of: evaluating (S102) at least a portion of the dosing event record with respect to the occurrence of irregularities in the time information included in the at least a portion of the dosing event record.

9. The method according to claim 8, wherein, The evaluation is based on the information stored in the dosing event record and / or the time information from the recording unit (11) and / or the time information from the receiving unit (71).

10. The method according to claim 8 or 9, wherein, This irregularity is a reset event of the recording unit (11), at which reset event the timer of the recording unit (11) is reset, such that T RTC changes to T RTC 's default value, such as zero.

11. The method according to any one of claims 7 to 10, wherein, The occurrence of irregularities is evaluated based on the detection of changes in a variable Δ, where Δ is a function of the time information from the recording unit (11) and the time information from the receiving unit (71), for example where Δ is T RTC_m and T 客户_p a function of, preferably, Δ = T 客户_p - T RTC_m , wherein, a)T RTC_m is the transmission-related time information of the recording unit (11), which indicates the time (m) at which at least one part of the dose event record is transmitted for reception by the receiving unit (71); and b)T 客户_p is the time information from the receiving unit (71) indicating the time (p) at which the receiving unit (71) received the at least one portion of the dose event record.

12. The method according to any one of claims 8 to 11, further referring to claim 5 or 6, wherein, the determination function for the specific dosing event (e) is selectable from a plurality of different determination functions or is selected (S103) from a plurality of different determination functions, depending on the occurrence of irregularities in the time information of at least a portion of the dosing event record during the determination period.

13. The method according to claim 12, wherein, a) If the determination period does not contain an irregularity, or if after the last reset of T in the determination period RTC T is recorded 剂量 (e) For the dose event to be determined, select the determination function g, where the last reset of T RTC is such a reset of T in the determination period that there is no subsequent reset of T in the determination period after that; and / or RTC i.e., there is no subsequent reset of T in the determination period after that; and / or RTC ​ b) if the determination period starts after the time (p) at which at least a part of the dose event record has been received by the receiving unit, and further if T is recorded before the first reset within the determination period RTC before T is recorded 剂量 (e) for the dose event (e) for which the determination is to be made, select the determination function h; and / or c) In any other case, for example, if between the n-th reset of T and the (n + 1)-th reset of T within the determination period, T is recorded RTC and the dose event to be determined is selected for the determination function i, where n ≥ 1. RTC between the n-th reset of T and the (n + 1)-th reset of T 剂量 and T is recorded 14. The method according to claim 13, wherein, T 剂量 (e) = g(T 客户 -(T RTC_传输 -T 时间戳 (e))), and / or T 剂量 (e) = h(Δ 目前的 + T 时间戳 (e)), and / or T 剂量 (e) = i(T 用户 (e 其他 ) - T 时间戳 (e 其他 ) + T 时间戳 (e)) wherein, a)T 时间戳 (e) is the time information related to the dosing event of the recording unit (11), which indicates the time when the dosing event (e) is recorded in the dosing event record; b)T RTC_传输 is the transmission-related time information of the recording unit (11), which indicates the time at which at least one part of the dose event record is transmitted for reception by the receiving unit (71); c)T RTC_m is the transmission-related time information of the recording unit (11), which indicates the time (m) at which at least one part of the dose event record is transmitted for reception by the receiving unit (71); d)T 客户 is time information from the receiving unit (71) indicating the time at which the receiving unit (71) received the at least one portion of the dose event record; e)T 客户_p is time information from the receiving unit (71) indicating the time (p) at which the receiving unit (71) received the at least one portion of the dose event record; f) Δ 目前的 is a variable indicating the time deviation between the recording unit (11) and the receiving unit (71), which is determined based on the time information from the recording unit (11) and the time information from the receiving unit (71), for example based on T RTC_m and T 客户_p ; g)T 用户 (e 其他 ) is the user key-in time of another dosing event (e 其他 ) that is recorded in the same portion of the determined period in the dosing event record as the dosing event (e); h)t 时间戳 (e 其他 ) is the time information related to the dose event of the recording unit (11), which indicates the time when the other dose event (e 其他 ) is recorded in the dose event record; and wherein, g, h, and i are functions of the variables and / or expressions specified in the parentheses.

15. The method according to any one of claims 8 to 11, further referring to claim 5 or 6, wherein, The determination function for the particular dosing event (e) is selectable from or selected from a plurality of different determination functions (S103), depending on the occurrence of an irregularity in the time information of the at least one portion of the dosing event record during the determination period and / or depending on whether the determination period begins with a reset of T RTC where a) If the determination period starts with a reset of T RTC and contains no irregularities, or if T RTC is recorded after the last reset of T 剂量 during the determination period and (e) the dose event to be determined is selected, then the determination function g is selected, where this last reset of T RTC is such a reset of T RTC during the determination period that there is no subsequent reset of T RTC during the determination period after that; and / or b) If T is recorded between the first dose event recorded in the dose event record and the first irregularity in the defined period 剂量 (e) the dose event to be determined, then select the determination function j; and / or c) If there is no reset of T during this determination period RTC then select the determination function k; and / or d) if the determination period starts after the time (p) when at least a portion of the dosing event record is successfully received by the receiving unit (71), and If T is reset for the first time within this determination period RTC and T was previously recorded 剂量 (e) and if the dose event (e) for which the determination is to be made is selected, then select the determination function l Among them, for T RTC this first reset of is such a reset in the determination period that there has been no previous reset of T RTC in the determination period before this one.

16. The method according to claim 15, wherein, T 剂量 (e) = g(T 客户 -(T RTC_传输 -T 时间戳 (e))), and / or T 剂量 (e) = j(T RTC_FDE + T 时间戳 (e)), and / or T 剂量 (e) = k(T 客户_p+1 -(T RTC_m+1 -T 时间戳 (e)) * CF), and / or T 剂量 (e) = l(T 客户_p -(T RTc_m -T 时间戳 (e))) wherein, a)T 时间戳 (e) is the time information related to the dose event of the recording unit (11), which indicates the time when the dose event (e) is recorded in the dose event record; b)T RTC_传输 is the transmission-related time information of the recording unit (11), which indicates the time when at least a part of the dose event record is transmitted for reception by the receiving unit (71); c)T RTC_m is time information related to transmission of the recording unit (11), which indicates a first time point (m) at which at least one part of the dose event record is transmitted for reception by the receiving unit (71); d)T RTC_FDE is the first dose event time information of the recording unit (11), which indicates the time when the first dose event is recorded in the dose event record; e)T RTC_m+1 is transmission-related time information of the recording unit (11), which indicates a second time point (m+1) at which at least a second part of the dose event record is transmitted for reception by the receiving unit (71), and the second time point (m+1) is a time point after a first time point (m) at which a first part of the dose event record has been transmitted for reception by the receiving unit; f)T 客户 is time information from the receiving unit (71) indicating the time at which the at least one portion of the dose event record was received by the receiving unit (71); g)T 客户_p is time information from the receiving unit (71) indicating a third time point (p) at which the at least one portion of the dose event record is received by the receiving unit (71); h)T 客户_p+1 is the time information of the receiving unit (71), which indicates the fourth time point (p+1) at which the second part of the dose event record is received by the receiving unit (71), and the fourth time point (p+1) is a time point after the third time point (p) at which the first part of the dose event record has been received by the receiving unit; i) CF is a correction factor, which is a function of the time information from the recording unit (11) and the time information from the receiving unit (71), for example and wherein, g, j, k, and l are functions of the variables and / or expressions specified in the parentheses.

17. The method according to any one of the preceding claims, wherein, a) Before determining T 剂量 (e), the method comprises the steps of: transferring (S90) at least one part of the dose event record from the recording unit (11) to the receiving unit (71), and / or wherein, b) Before transmitting (S90) the at least one portion of the dose event record, the method comprises the steps of: recording (S80) in the dose event record, with a recording unit (71), information related to one or more dose events (e1 to e z ) performed with a medical device.

18. A device (70) for processing a dose event (e1 to e z ) for determining an absolute time or a reference time T 剂量 of one or more recorded dose events performed with a medical device, wherein, e represents a specific dosing event among the one or more dosing events, and the dosing event processing device (70) includes: a receiving unit (71) configured to receive at least a portion of a dosing event record; and a processing unit (72), wherein, the dosing event processing device (70) is configured to perform the method according to any one of claims 1 to 17.

19. The dosing event processing device (70) according to claim 18, further comprising a user interface (73) operatively connected to the receiving unit (71).

20. A computer-readable storage medium, such as a non-transitory computer-readable storage medium, having stored thereon a computer program product, the computer program product including machine-readable instructions that, when executed by a processing unit (72), cause the dose event processing device (70) as recited in claim 18 or 19 to perform the method as recited in any one of claims 1 to 17 or to control the method as recited in any one of claims 1 to 17.

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