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

Abstract

One or more recorded administration events (e1 to e) performed by the medical device z ) absolute time T Dose A method for determining (e), wherein e characterizes a particular administration event, the one or more administration events e are recorded in an administration event record, and at least a portion of the administration event record is received or receivable by a receiving unit (71) (S100), comprising: T Dose (e) is determined (S104) based on at least one time information from the recording unit (11) that stored the administration event in the administration event record and at least one time information from the receiving unit (71).

Description

[Technical Field]

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

[0002] For example, in diabetes treatment, if a patient takes too much insulin in a certain period of time, it may lead to hypoglycemia, which can have serious effects on the patient. Therefore, the patient needs to know the dosage and frequency of administration so as not to exceed a critical amount of insulin in a certain period of time, for example, a critical daily amount.

[0003] Typically, doses of insulin are administered using a drug delivery device. Such drug delivery devices may provide functionality to record information about the amount of drug and the time the drug was administered, for example in a dose record or dose log. Alternatively or additionally, there are add-on devices for drug delivery devices that may provide such functionality.

[0004] Typically, the time information is obtained within the medication delivery device or add-on device using a timer, for example a real-time clock.

[0005] Based on the information obtained by the timer, the administration time T at which dose e was administered is recorded to generate an administration log that can be used as a reference for the patient or a medical professional to monitor dose administration. Dose (e) is calculated.

[0006] This means that according to the prior art, determining the number of doses is entirely dependent on the accuracy of the real time clock within the medication device or add-on device. Summary of the Invention [Problem to be solved by the invention]

[0007] Given that this real-time clock is never perfectly accurate, there will always be a slight deviation between the registered time and the actual time the dose was administered. This deviation or drift increases over time, as does any inaccuracy in the dose log. This is potentially dangerous to the patient. [Means for solving the problem]

[0008] An object of the present disclosure is to provide improvements regarding the determination of the absolute time of a recorded administration event.

[0009] The terms "drug" or "medication" are used synonymously herein to refer to a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. Drugs or medicaments may be used for a limited duration or periodically in the case of chronic conditions. Further explanation regarding "drug" or "medication" can be found at the end of the description of exemplary embodiments.

[0010] Hereinafter, the term "distal" refers to the direction toward the medical device, drug delivery device, or drug container from which the drug is expelled. Accordingly, the term "proximal" refers to the opposite direction. With respect to a pen-type drug delivery device, the term "distal" refers to the direction toward the injection site and / or the tip of the injection needle of the device. Accordingly, the term "proximal" refers to the direction away from the injection site and / or the tip of the injection needle of the device.

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

[0012] As used herein, the expression "administration event" relates to any operation or event that can be performed by a medical device configured to contain a drug, e.g., a drug delivery device. In particular, such operation or event may be setting and / or selecting an amount, i.e., an amount of drug, to be output, e.g., discharged or ejected, from the medical device. The amount may be selected by user action. Alternatively or additionally, the phrase "administration event" relates to any operation or event that can be performed by a medical device to output, e.g., eject and / or eject, a drug from the medical device in an amount of drug (which may be pre-selected) that may be injected into a patient's body, e.g., via a needle. It is understood that a drug may also be administered in other ways.

[0013] A "dose" may be the partial or total quantity of a drug that is set, selected, output, expelled, and / or released from a medical device in a single action. In particular, this is not limited to quantification based on units of drug. However, a "dose" may include one or more increments where administration can be quantified in increments only.

[0014] As used herein, the expressions "time" and "point in time" may be used interchangeably and describe time information for a particular operation, which may be the start or end of transmission of at least a portion of an administration event record from a recording unit to a receiving unit, where the start may be indicated by time information from the recording unit and the end may be indicated by time information from the receiving unit.

[0015] The above-mentioned objects are achieved by the subject matter disclosed herein, for example by the subject matter set out in the accompanying independent claims. Advantageous refinements and developments are found in the dependent claims and / or are disclosed in the following description.

[0016] One aspect of the present disclosure is to record one or more recorded administration events (e1-e) performed by a medical device. z ) absolute time T Dose Regarding the method for determining (e), e characterizes a particular administration event, and the subscript z is a positive integer greater than or equal to 1.

[0017] One or more administration events are recorded in an administration event record that includes information characterizing the one or more administration events contained in the administration event record.

[0018] The administration event record may be a continuous record of all administration events performed by the medical device, for example, while delivering medication from a reservoir or reservoirs.

[0019] At least a portion of the administration event record is received or receivable by the receiving unit. At least a portion of the administration event record includes one or more administration events e1 to e z The administration events may be consecutive administration events or a selected set of administration events recorded in the administration event record.

[0020] At least some of the administration event records may include a unique administration event identifier, a recording unit of dose and / or administration event related time information T indicating the time at which the administration event e was recorded in the at least some of the administration event records. Stamp (e) may include information relating to at least one of, any selected plurality of, or all of (e).

[0021] The administration event identifier may be unique, for example, within an administration event record or globally. The administration event identifier may be a unique number, text, or code combination that unambiguously identifies a particular administration event. The dose may be the quantity of drug set, selected, or output, e.g., by release, expulsion, etc., in a single administration event.

[0022] Absolute time T Dose (e) is determined based on at least one time information from the recording unit that recorded the administration event in the administration event record and at least one time information from the receiving unit.

[0023] In one embodiment, the time information from the recording unit is T Stamp (e), T RTC_trans , and TRTC_FDE It may include one, any selected number, or all of the following: T Stamp (e) may be administration event related time information of the recording unit indicating the time when administration event e was recorded in the administration event record. RTC_trans T may be transmission-related time information of the recording unit indicating the time when at least a portion of the administration event record including the administration event e was transmitted to be received by the receiving unit. RTC_FDE may be time information of the recording unit indicating the time when the first administration event was recorded by the recording unit in the administration event record.

[0024] In one embodiment, the time information from the recording unit is, for example, T Stamp (e) and T RTC_trans In other words, the time information from the recording unit may include one or all of, for example only, T RTC_FDE It may not include.

[0025] The time information from the receiving unit indicates the time at which at least a portion of the administration event record was received by the receiving unit, and Client May contain T Client may be absolute time, for example, time information synchronized with UTC.

[0026] The method may further comprise evaluating at least some of the administration event records received by the receiving unit for the occurrence of irregularities in the time information contained in at least some of the administration event records.

[0027] The evaluation is based on information stored in the administration event record, e.g., T Stamp or a unique administration event identifier, and / or time information from the recording unit, e.g., T RTC_trans Alternatively, the evaluation may be based solely on information stored in the administration event record and / or time information from the recording unit combined with time information from the receiving unit, e.g., T Client The method may be based on a combination of the above.

[0028] The evaluation of the occurrence of irregularities indicates that one or more recorded administration events e1-e z Absolute time T Dose This has the advantage that such irregularities can be taken into account when determining (e), i.e., T for different administration events can be calculated depending on when the administration event was recorded with respect to the irregularity. Dose A different decision function may be used to decide (e), which can advantageously improve the accuracy of the decision.

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

[0030] In one embodiment, T RTC The initial value of T may be set according to absolute time, for example Coordinated Universal Time (UTC), during the manufacture of the recording unit. RTC The initial value of may be set to correspond to the absolute time at which the timer started running, for example the moment the recording unit was connected to an energy source during assembly.

[0031] In one embodiment, the T at the moment the first administration event is recorded in the administration event record. RTC The value of T RTC_FDE In one embodiment, the T at the moment the first administration event is recorded in the administration event record. RTC The value may not be recorded.

[0032] In one embodiment, T RTC The value of T may be set to zero when the first administration event is recorded in the administration event record. RTCmay be set to zero after at least a portion of the administration event record has been transmitted for reception by the receiving unit and / or after the transmitted portion has been received by the receiving unit. RTC may be set to zero after each time a portion of an administration event record is transmitted for reception by the receiving unit and / or after a transmitted portion of an administration event record is received by the receiving unit. RTC By setting to zero, the time difference between the recording unit's timer and the exact real time, e.g., UTC, will cause T Dose This has the advantage of having less adverse effect on the accuracy of the judgment (e).

[0033] Time information T RTC may be in a format that is intuitive for humans to read, such as UTC. RTC may be in a format that is not intuitively readable by humans, such as UNIX time (epoch time). Such a format may be advantageous for processing time information.

[0034] The irregularity is the result of the timer in the recording unit being reset, RTC T RTC The default value may be any predetermined value different from zero. Alternatively, the default value may be zero.

[0035] In one embodiment, the irregularity is T RTC This may be a temporary suspension or pause in the process.

[0036] In one embodiment, the occurrence of irregularity may be assessed based on time information from the receiving unit and / or based on information stored in the administration event record and / or based on time information from the recording unit. The occurrence of irregularity may be assessed based on detecting a change, e.g., a step change, in the variable Δ, which indicates the time lag between the recording unit and the receiving unit.

[0037] In one embodiment, Δ may be determined after a time m when at least a portion of the administration event record is sent to be received by the receiving unit and after a time p when at least a portion of the administration event record is received by the receiving unit. Δ may be determined by using time information from the recording unit and time information from the receiving unit, e.g., T RTC_m and T Client_p The determination may be based on T RTC_m may be transmission-related time information of the recording unit, indicating the time m at which at least a portion of the administration event record was transmitted to be received by the receiving unit, and T Client_p may be time information from the receiving unit indicating the time at least a portion of the administration event record was received by the receiving unit.

[0038] In one embodiment, Δ may be determined according to the following formula: Δ=T Client_p -T RTC_m

[0039] In one embodiment, Δ may be determined each time a portion of the administration event record is received by the receiving unit. Alternatively, Δ may be determined less frequently, such as every time a portion of the administration event record is received by the receiving unit 2, 3, 4, 5, 10, 20, or 50 times.

[0040] One, some, or all of the determined values ​​may be stored as Δ pre In one embodiment, Δ pre If is judged more than once, Δ pre is the latest Δ pre Alternatively, multiple or all determined Δ pre with successively increasing index i, pre_i may be stored in memory as

[0041] Apart from slight drift due to design tolerances of the electronic components of the recording unit and / or receiving unit, Δ may remain approximately constant if there are no irregularities in the administration event recording. Thus, in one embodiment, the occurrence of irregularities in the administration event recording may be assessed based on detecting a change in the variable Δ, e.g., a step change.

[0042] In one embodiment, this change is calculated by subtracting the most recent value of Δ from the stored Δ pre_i or the preserved Δ pre In this comparison and the evaluation of the occurrence of irregularities in the administration event records from the comparison results, multiple Δ pre_i It is advantageous to compare Δ with Δ.

[0043] In one embodiment, no portion of the administration event record has been previously transmitted and is therefore available for determining a change. pre_i or Δ pre If there is no T RTC The determination of whether there is a reset of T may be based on information stored in the administration event record. For example, Stamp If (e) does not increase, this is the T RTC Alternatively or additionally, the irregularity indicates a reset of the corresponding T Stamp (e) can be detected based on the unique administration event identifiers of two or more administration events in combination with (f). By considering the administration event identifiers of several administration events, even if T Stamp It becomes possible to detect trends so that irregularities can be detected even if (e) increases continuously.

[0044] The method may include defining, in at least some of the administration event records received by the receiving unit, decision periods, where the decision periods are T Dose One or more administration events e for which (e) is determined i ~e k where k≧i>1.

[0045] The judgment period is T Dose (e) is determined from at least a portion of the administration event record recorded administration event e i ~e k The administration event identifier may be determined based on the administration event identifier.

[0046] In one embodiment, e i ~e k is T Dose (e) may be a previously undetermined administration event. Alternatively, e i ~e k At least one of the T may be an administration event that has already been determined one or several times before. Dose (e) There is the potential for the method to be more robust and accurate by including previously determined administration events.

[0047] In one embodiment, the determination period may be selected by a user, for example, via a user interface operatively connected to the receiving unit.

[0048] In one embodiment, the determination period may span the entire length of the received portion of the administration event record.

[0049] One or more administration events i ~e k The absolute time T within the judgment period of a specific administration event e Dose (e) may be determined using a determination function.

[0050] The decision function f may be a function of the time information from the recording unit and the time information from the receiving unit.

[0051] In one embodiment, the decision function f is T Dose (e)=f(T Client , T RTC_trans , T Stamp (e)) may be used.

[0052] In one embodiment, the decision function f is a difference T between the time information from the receiving unit and the different time information from the recording unit. RTC_trans -T Stamp (e) function, e.g., T Dose (e)=f(T Client , (T RTC_trans -T Stamp (e))) may be.

[0053] In one embodiment, the decision function f is the difference T between the time information from the receiving unit and the time information from the recording unit. RTC_trans -T Stamp (e) function, e.g., T Dose (e)=f(T Client -(T RTC_trans -T Stamp (e))) may be.

[0054] In one embodiment, the decision function f is T Dose (e)=(T Client -(T RTC_trans -T Stamp (e)) may be used.

[0055] In one embodiment, the time information of the recording unit includes transmission-related time information T of the recording unit indicating a first time point m at which at least a first portion of the administration event record was transmitted for reception by the receiving unit. RTC_m If no such transmission of at least the first portion of the administration event record has previously occurred, T RTC_m T RTC For example, T RTC_m may be set to zero.

[0056] In one embodiment, the time information of the recording unit is a transmission-related time information T of the recording unit indicating a second time point m+1 at which at least a second portion of the administration event record was transmitted for reception by the receiving unit. RTC_m+1 In one embodiment, the determination period may include T RTC_m and T RTC_m+1 The range may be between

[0057] In one embodiment, the time information from the receiving unit includes receiving unit time information T Client_p The third time point may be earlier than the second time point.

[0058] In one embodiment, the time information from the receiving unit includes receiving unit time information T Client_p+1 If, at a third time, no portion of the administration event record has been received by the receiving unit, said second portion of the administration event record may be at least a portion of the administration event record as described above.

[0059] In one embodiment, the decision function for a particular administration event may be selectable or selected from a plurality of different decision functions f depending on the occurrence of irregularities in the time information of at least some of the administration event records during the decision period.

[0060] In one embodiment, the decision function g may be selected if the decision period does not include any irregularities. Dose (e) The administration event to be judged is T during the judgment period. RTC In this context, T RTC The final reset of T occurs after the evaluation period ends. RTC There is no subsequent reset of T during the judgment period. RTC In other words, T RTC and the time at least a portion of the administration event record is transmitted for reception by the receiving unit.

[0061] In one embodiment, the decision function g is a function whose decision period is T RTC This may be selected when starting with a reset of the

[0062] In one embodiment, the determination period begins after time p when at least a portion of the administration event record is received by the receiving unit and T Dose (e) The administration event e to be judged is within the judgment period T RTC The decision function h may be selected when the value of h is recorded before the first reset of the time series.

[0063] In one embodiment, if neither the condition for selecting g nor h is met, then the decision function i may be selected. For example, i may be T Dose (e) The administration event e to be judged is T RTC nth reset of and T RTC This may be selected if the data is recorded during the n+1th reset (n≧1).

[0064] The decision function i is T Stamp (e), T User (e other ) and T Stamp (e other ) may be a function of

[0065] T Stamp (e) may be administration event related time information for the record unit indicating the time when administration event e was recorded in the administration event record, as described above.

[0066] T User (e other ) is T Dose (e) is judged as the administration event e and the other administration event e recorded in the same judgment period part other In this context, the "same part" may be the user input time of administration event e and administration event e other In the administration event record during T RTC This means that there is no irregularity or resetting of T Dose (e) The administration event e to be judged is T RTC nth reset of and T RTC If recorded during the n+1 reset (n ≥ 1) of the other administration event e othermust also be recorded between the nth reset event and the n+1th reset event during the evaluation period.

[0067] T Stamp (e other ) is the other administration event e other may be administration event related time information of the recording unit indicating the time at which the administration event was recorded in the administration event record.

[0068] In one embodiment, the decision functions g, h, and i may be different decision functions.

[0069] In one embodiment, at least two of the decision functions g, h, and i may be equivalent decision functions.

[0070] The absolute time T of a particular administration event e recorded in the administration event record Dose (e) may be determined according to one of the following determination functions: T Dose (e)=g(T Client -(T RTC_trans -T Stamp (e))), and / or T Dose (e)=h(Δ pre +T Stamp (e)), and / or T Dose (e)=i(T User (e other )-T Stamp (e other )+T Stamp (e)).

[0071] In one embodiment, the decision functions g, h, and i may be functions of the variables and / or formulas specified within the brackets.

[0072] In one embodiment, the decision function g holds: T Dose (e)=T Client -(T RTC_trans -T Stamp (e))

[0073] In one embodiment, the decision function h holds: T Dose (e)=Δ pre +T Stamp (e)

[0074] In one embodiment, the following equation holds true for the decision function i: T Dose (e)=T User (e other )-T Stamp (e other )+T Stamp (e)

[0075] In one embodiment, T Dose The judgment function j may be selected if the administration event for which (e) is judged is recorded between the first administration event recorded in the administration event record during the judgment period and the first irregularity. In other words, by referring to the first administration event recorded in the administration event record, it can be seen that the judgment function j may be selected if the judgment period starts from the first administration event recorded in the administration event record.

[0076] In one embodiment, during the determination period, T RTC If there is no reset of , the decision function k may be selected.

[0077] In one embodiment, the determination period begins after a previous time point p at which at least a portion of the administration event record was successfully received by the receiving unit, and further T RTC is not its default value at the start of the evaluation period, and T Dose (e) The administration event e to be judged is T within the judgment period. RTC If the decision function l is recorded before the first reset of T RTC The first reset of T before the start of the evaluation period RTC There is no prior reset of T during the judgment period. RTC This is a reset.

[0078] In one embodiment, the decision functions g, j, k and l may be different decision functions.

[0079] In one embodiment, at least two of the decision functions g, j, k, and l may be equivalent decision functions.

[0080] In one embodiment, T RTC , T RTC_FDE , T RTC_trans , T RTC_m , T RTC_m+1 , T Stamp (e), T Stamp (e other ), T User (e other ), T Client , T Client_p , and T Client_p+1 One, an arbitrarily selected number, or all of the above may be determined according to an absolute time, for example, Coordinated Universal Time (UTC).

[0081] In one embodiment, the T of the receiving unit Client , T Client_p and T Client_p+1 may indicate the time at which at least a portion of the administration event record was received by the receiving unit.

[0082] In one embodiment, T RTC , T RTC_FDE , T RTC_trans , T RTC_m , T RTC_m+1 , T Stamp (e), T Stamp (e other ), T User (e other ), T Client , T Client_p , and T Client_p+1 One of the above, or a plurality of arbitrarily selected ones, or all of them may be time information in a format that is not intuitively readable by humans, for example, UNIX time (epoch time).

[0083] In one embodiment, taking into account irregularities in the previous transmission of the administration event records and / or at least some of the administration event records received by the receiving unit, all time information that is not in a format that is intuitively human readable may be converted to time information that is intuitively human readable, for example UTC.

[0084] In one embodiment, the absolute time T of the administration event Dose (e) is the administration event related time information T Stamp (e) may be determined based on a determination function that converts (e) into a format that is intuitively readable by humans so that it can be understood by humans without further conversion, such as UTC or any other time format suitable for accurately indicating the time of the administration event.

[0085] In one embodiment, the absolute time T of a particular administration event e recorded in the administration event record Dose (e) may be determined according to one of the following determination functions: T Dose (e)=g(T Client -(T RTC_trans -T Stamp (e))), and / or T Dose (e)=j(T RTC_FDE +T Stamp (e)), and / or T Dose (e)=k(T Client_p+1 -(T RTC_m+1 -T Stamp (e))*CF), and / or T Dose (e)=l(T Client_p -(T RTC_m -T Stamp (e)))

[0086] In one embodiment, the decision functions g, j, k, and l may be functions of the variables and / or formulas specified within the brackets.

[0087] In one embodiment, the decision function g holds: T Dose (e)=T Client -(TRTC_trans -T Stamp (e))

[0088] In one embodiment, the decision function j holds: T Dose (e)=T RTC_FDE +T Stamp (e)

[0089] In one embodiment, the following equation holds true for the decision function k: T Dose (e)=T Client_p+1 -(T RTC_m+1 -T Stamp (e))*CF

[0090] In the judgment function k, CF is a correction coefficient. The correction coefficient may be a function of the time information from the recording unit and the time information from the receiving unit. The correction coefficient is used to determine the time difference between the time information of the recording unit and the time information of the receiving unit, for example, the T RTC and absolute time, e.g., T for UTC. Client (Example: T Client_p or T Client_p+1 ) may be configured to compensate for time drift.

[0091] In one embodiment, the correction factor may be determined according to the following formula:

number

[0092] In one embodiment, the decision function l holds: T Dose (e)=T Client_p+1 -(T RTC_m+1 -T Stamp (e))

[0093] In one embodiment, T Dose Prior to determining (e), the method may include transmitting at least a portion of the administration event record from the recording unit to a receiving unit.

[0094] In one embodiment, the transmission may be wireless, such as Bluetooth, Bluetooth low energy, near field communication (NFC), or any other suitable wireless technology. Alternatively, the transmission may be wired, such as via a universal serial bus (USB).

[0095] In one embodiment, prior to transmitting at least a portion of the dispensing event record, the method may include recording information about the one or more dispensing events in the dispensing event record using a recording unit.

[0096] 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 about one or more administration events performed by the medical device in an administration event record. The recording unit includes a T RTC The recording unit includes a timer configured to provide time information to the recording unit, the time information being a time when the recording unit is started. The storage unit is configured to store the administration event record. The storage unit may form part of the recording unit. The energy source is configured to provide electrical energy to the recording unit and / or the storage unit.

[0097] In one embodiment, the device may be configured to be attachable to a medical device. The medical device may be a drug delivery device. The drug delivery device may be a user-settable variable dose device, a so-called variable dose device. The drug delivery device may be a syringe. The drug delivery device may be a pen-type device.

[0098] The device may be attachable to a dose setting unit, a dose setting mechanism, an activation mechanism, a release unit and / or a housing of a medical device.

[0099] The device may be configured to be attachable to a medical device such that a user can perform administration events with the medical device via the device.

[0100] The timer of the recording unit may include a real-time clock, which may be synchronized with an absolute time, e.g., UTC, during manufacture of the recording unit or during assembly of some or all of the elements of the device. RTC The starting value of T may be set to correspond to the absolute time when the timer begins to run, e.g., when it is connected to an energy source. RTC The starting value of may be any predetermined value, for example zero or a value different from zero.

[0101] In one embodiment, the value of TRTC at the moment the first administration event is recorded in the administration event record is T RTC_FDE In one embodiment, the T at the moment the first administration event is recorded in the administration event record may be stored as RTC The value may not be saved.

[0102] In one embodiment, T RTC may be set to zero after at least a portion of the administration event record has been transmitted for reception by the receiving unit and / or after the transmitted portion has been received by the receiving unit. RTC may be set to zero each time after a portion of an administration event record is transmitted for reception by the receiving unit and / or after a transmitted portion of an administration event record is received by the receiving unit.

[0103] Time information T RTC may be in an intuitive human-readable format, such as Coordinated Universal Time (UTC). RTC may be in a format that is not intuitively readable by humans, such as UNIX time (epoch time).

[0104] The time information from the recording unit is T Stamp (e), T RTC_trans , T RTC_m , T RTC_m+1 , and T RTC_FDE One or a selected number or all of the following may be included: T Stamp (e), TRTC_trans , T RTC_m , T RTC_m+1 , and T RTC_FDE is the time information of the recording unit as described above.

[0105] The time information from the receiving unit is Client , T Client_p , and T Client_p+1 may include one or all of T Client , T Client_p , and T Client_p+1 is the time information of the receiving unit as described above.

[0106] In one embodiment, the index m may be incremented by 1 each time a portion of the administration event record is sent for receipt by the receiving unit, and similarly, the index p may be incremented by 1 each time a portion of the administration event record is successfully received by the receiving unit.

[0107] In one embodiment, the receiving unit may be part of a dispensing event processing device.

[0108] In one embodiment, the T at the moment the first administration event is recorded in the administration event record. RTC The value of T is stored in the storage unit. RTC_FDE In one embodiment, the T at the moment the first administration event is recorded in the administration event record may be stored as RTC The value may not be saved.

[0109] In one embodiment, the device is or forms part of an add-on device. For example, the device may be an add-on device that includes an electronic button. The device may be configured to be attached or attachable to a medical device. The device may be attachable to a drug delivery device, such as the devices described further above.

[0110] Another aspect of the present disclosure relates to a medical device including a device, a dose setting unit and a dose releasing unit.

[0111] The medical device may be a drug delivery device, such as those further described above.

[0112] The dose setting unit may be operatively connected to the dose releasing unit such that the dose set using the dose setting unit can be released by the dose releasing unit.

[0113] The device may be configured to record administration events performed by the medical device in an administration event record. The device may be removably attached to the medical device. Alternatively, the device may be fixedly attached to the medical device. Alternatively, the device may be integrally formed with the medical device. The device may be a device described in the previous paragraph.

[0114] The medical device may further include a holder for holding the drug container and / or the drug container having an interior space for containing the drug. The drug container may further include a stopper configured to move within the interior space when moved distally to expel the drug from the drug container.

[0115] The dose-ejection unit may include a drive unit and a plunger. The drive unit may be configured to provide a force for axially moving the plunger. The plunger may be configured to transmit movement driven by the force of the drive unit to a stopper of the medicament container. The stopper may be configured to expel the medicament from the medicament container when moved distally within the interior space.

[0116] In one embodiment, the plunger may be configured such that its distal end forms a stopper for the medicament container, i.e., the distal end of the plunger may be configured to move within the interior space when moved distally, thereby expelling the medicament from the interior space.

[0117] In one embodiment, the drive unit may be a mechanism that transfers a user's force to the plunger.

[0118] In one embodiment, the drive unit may be a drive spring, which may be pre-tensioned, for example during dose setting or selection, or may be tensioned in situ in response to user manipulation of the medical device.

[0119] The medical device may further include a cap and / or needle mount for mounting the needle unit on the device. The cap may be configured to fully or partially cover the needle when the cap is attached to the medical device and the needle unit is mounted thereon.

[0120] Another aspect of the present disclosure is to provide a method for recording one or more recorded dispensing events e1-e performed by a medical device. z Absolute time T Dose The administration event processing device determines (e), where e characterizes a particular administration event of the one or more administration events. The administration event processing device includes a receiving unit and a processing unit. The receiving unit receives one or more recorded administration events e1 to e z The administration event processor is configured to receive at least a portion of the administration event record including one or more recorded administration events e1 to e recorded in the received portion of the administration event record. z Absolute time T Dose It is configured to determine (e).

[0121] In one embodiment, the administration event processing device processes one or more recorded administration events e1 to e z Absolute time T Dose The determination function for a particular administration event e may be configured to determine the time stamp T of the particular administration event e in response to the occurrence of irregularities in the time information of the received portion of the administration event record, as described in the paragraph above, and / or in relation to the irregularities in the administration event record. Stamp (e) may be taken into consideration when selecting the

[0122] In one embodiment, the decision function for a particular administration event e is such that the decision period including the particular administration event e is T RTCIt may additionally be selected depending on whether it starts from a reset of the

[0123] In one embodiment, the processing unit may be configured to perform the method according to the aspects of the present disclosure.

[0124] The administration event processing device may further include a user interface, which may be operatively connected to the receiving unit and / or the processing unit, and which may be configured to receive user input, such as a user selection of a determination period in the received portion of the administration event record.

[0125] The administration event processor may be part of, or form part of, a mobile device, such as a smartphone, tablet, or portable computer, or alternatively, the administration event processor may be part of, or form part of, a stationary processing device, such as a stationary computer or server.

[0126] Another aspect of the present disclosure relates to a computer program product including machine-readable instructions that, when executed by a processing unit, cause an administration event processor to process one or more recorded administration events e1-e performed by the medical device. z Absolute time T Dose (e) The administration event processor may be an administration event processor according to an aspect of the present disclosure. The method may be a method according to an aspect of the present disclosure.

[0127] Another aspect of the present disclosure relates to a computer-readable storage medium, e.g., a non-transitory computer-readable storage medium having stored thereon a computer program product including machine-readable instructions that, when executed by a processing unit, cause a dosing event processor to record one or more recorded dosing events e1-e performed by a medical device. z Absolute time T Dose(e) The computer program product may be a computer program product according to an aspect of the present disclosure.

[0128] In other words, one aspect of the present disclosure relates to a computer-readable storage medium, e.g., a computer program product having stored thereon machine-readable instructions that, when executed by a processing unit of an administration event processor, cause the administration event processor to record one or more recorded administration events e1-e performed by the medical device. z Absolute time T Dose A method is performed to determine (e), where e characterizes a particular administration event and the subscript z is a positive integer.

[0129] In one embodiment, the method may be a method according to an aspect of the present disclosure.

[0130] In one embodiment, the administration event processor may be an administration event processor according to an aspect of the present disclosure.

[0131] The methods, devices and apparatus of the present disclosure provide the advantage of being able to accurately and reliably determine the absolute time of one or more administration events performed by a medical device, even if the recording unit is powered down, causing the recording unit's timer to stop or reset, or if the recording unit is subject to electromagnetic interference.

[0132] In particular, in contrast to conventional approaches, the present disclosure provides a method for determining the T of administration events recorded before and after resetting the timer of the recording unit. Dose (e) can be judged reliably. This means that T RTC This is because it takes into account and compensates for possible resets or shutdowns of the

[0133] Additionally, since there is no need to store the time of first use in the recording unit, the method, apparatus and device are more robust against loss of time information. Because time information from the recording unit and the receiving unit is used, drift of the recording unit's timer compared to absolute time can be compensated for.

[0134] It should be noted that all aspects illustratively described above may be combined with other aspects or portions thereof as described above, even if such combination of aspects and portions is not explicitly mentioned. [Brief explanation of the drawings]

[0135] [Figure 1] 10A-10C illustrate schematic steps of a method for determining absolute times of administration events performed and recorded by a medical device, according to one embodiment of the present disclosure; [Figure 2] FIG. 10 shows administration events and corresponding time information in the recording unit and the receiving unit, where there is no irregularity in the time information of administration event records during the illustrated evaluation period. [Figure 3] FIG. 1 shows administration events and corresponding time information in the recording unit and the receiving unit, where there is one irregularity in the time information of administration event records during the illustrated evaluation period. [Figure 4] FIG. 1 shows a diagram of administration events and corresponding time information of a recording unit and a receiving unit, in which there are two different determination periods without irregularity in the time information of administration event records. [Figure 5] FIG. 1 shows a diagram illustrating administration events and corresponding time information of the recording unit and the receiving unit, in which there are two different determination periods, and the second determination period contains irregularities in the time information of the administration event records. [Figure 6] FIG. 10 is a diagram showing administration events and corresponding time information of the recording unit and the receiving unit, in which there are two different judgment periods, and the second judgment period contains two irregularities in the time information of the administration event records. [Figure 7] 1 illustrates a schematic diagram of an apparatus for a medical device according to one embodiment of the present disclosure. [Figure 8] 1 illustrates a schematic diagram of a dosing event processing device according to an embodiment of the present disclosure. [Figure 9] 1 illustrates a schematic diagram of a medical device according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0136] Identical elements, elements of the same type, and elements that operate in the same or similar manner may be given the same reference numbers in the drawings.

[0137] As outlined above, it is an object of the present disclosure to provide improvements regarding the determination of the absolute time of a recorded administration event, particularly if the real-time clock is reset before the administration event is recorded. A further object of the present disclosure is to eliminate the need to store the time of the first administration event performed by a medical device.

[0138] FIG. 1 illustrates one or more recorded administration events e1-e performed by a medical device, according to one embodiment of the present disclosure. z Absolute time T Dose 10 illustrates exemplary steps of a method for determining (e), where e is the administration event e1 to e recorded in the administration event record. z The method begins with step S100, in which at least a portion of a dispensing event record including at least one dispensing event e is received by the receiving unit 71 (see FIG. 8).

[0139] According to this method, T Dose (e) is determined based on at least one piece of time information from the recording unit 11 that recorded the administration event for the administration event record (see FIG. 7) and at least one piece of time information from the receiving unit 71.

[0140] At least a portion of the administration event record includes a unique administration event identifier, the administration amount, and administration event related time information T in the recording unit 11 indicating the time at which the administration event e was recorded in at least a portion of the administration event record. Stamp It may include information relating to at least one, any selected number, or all of (e).

[0141] The administration event identifier may be a unique number, text, or code combination that unambiguously identifies a particular administration event e. The dose may be the quantity of medication that is set, selected, or output in a single administration event.

[0142] The time information from the recording unit 11 is T Stamp (e), T RTC_trans and T RTC_FDE It may include one, any selected number, or all of the following: T Stamp (e) may be administration event related time information of the recording unit 11 indicating the time when the administration event e was recorded in the administration event record. RTC_trans may be transmission-related time information of the recording unit 11 indicating the time when at least a portion of the administration event record including the administration event e was transmitted to be received by the receiving unit 71. RTC_FDE may be the recording unit's first administration event time information indicating the time when the recording unit 11 recorded the first administration event in the administration event record.

[0143] The time information from the receiving unit 71 includes a time T Client In one embodiment, the time information of the receiving unit 71 may be synchronized with an absolute time, for example Coordinated Universal Time (UTC).

[0144] The recording unit 11 includes a timer (not shown) configured to provide time information for the recording unit 11, the time information being T RTCThe timer of the recording unit 11 may include a real-time clock. RTC The start value of may be set to correspond to the absolute time at which the timer starts running, for example when the recording unit is connected to an energy source during assembly.

[0145] In one embodiment, the T at the moment the first administration event is recorded in the administration event record. RTC The value of T RTC_FDE It may be saved as

[0146] In one embodiment, T RTC The value of T is set to zero when the first administration event is recorded in the administration event record. RTC may be set to zero after at least a portion of the administration 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 may be set to zero each time after a portion of an administration event record is transmitted to be received by the receiving unit and / or after a transmitted portion of an administration event record is received by the receiving unit 71.

[0147] After at least a portion of the administration event record is received by the receiving unit 71, in step S101, a decision period in the received portion of the administration event record is determined.

[0148] The judgment period is absolute time T Dose (e) All administration events e i ~e k For example, the decision period is a portion of the received portion of the administration event record that includes T Dose(e) may be determined according to the unique administration event identifiers of administration events in the received portion of the administration event record that have not yet been determined. Alternatively, the determination period may be selected by a user, for example, via a user interface 73 (see FIG. 8) operably connected to the receiving unit 71. Alternatively, the determination period may span the entire length of the received portion of the administration event record.

[0149] The administration event identifier may be a unique number, text or code combination that can unambiguously identify one particular administration event. Apart from the unique administration event identifier, the administration record also contains information about the dose of each administration and administration event related time information T in the recording unit that indicates the time when the administration event e was recorded in the administration event record. Stamp (e) A dose may be the quantity of a drug that is set, selected, or output in one administration event.

[0150] According to step S102, the time information contained in the administration event records within the evaluation period is evaluated for the occurrence of irregularities.

[0151] The evaluation may be based on time information from the recording unit 11 and / or based on information recorded in the administration event record and / or based on time information from the receiving unit 71.

[0152] In one embodiment, the occurrence of irregularity is assessed based on detecting a change, e.g., a step change, in a variable Δ that indicates the time lag between the recording unit 11 and the receiving unit 71. After at least a portion of the administration event record is received by the receiving unit 71, Δ is calculated 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 Client_p In one embodiment, T RTC_m is the transmission-related time information of the recording unit indicating the time m at which at least a portion of the administration event record was transmitted to be received by the receiving unit, and T Client_pis time information from the receiving unit indicating the time p at which at least a portion of the administration event record was received by the receiving unit. In one embodiment, Δ is expressed by the formula: Δ=T Client_p -T RTC_m It may be judged according to

[0153] In one embodiment, Δ is determined each time a portion of a dispensing event record is received by receiving unit 71. Each determined value of Δ is stored as Δ for further processing at a later time. pre_i Alternatively, Δ may be determined less frequently, for example, every time a portion of the administration event record is received by the receiving unit 2, 3, 4, 5, 10, 20, or 50 times. In one embodiment, only the most recently determined Δ is stored as Δ pre may be stored in the recording unit 11 as

[0154] In one embodiment, the change is calculated by subtracting the most recent value of Δ from the stored Δ pre_i or the preserved Δ pre It can be detected by comparing it with one of the

[0155] The irregularity is the result of the timer of the recording unit 11 being reset, RTC T RTC In one embodiment, the default value is zero. Alternatively, the default value may be different from zero.

[0156] In step S103, based on the result of the evaluation of the irregularity of the time information of the administration event record, i ~e k T Dose Further, the decision function is to determine the timestamp T of the administration event e with respect to the irregularity of the administration event recording. Stamp In one embodiment, the decision function is selected taking into account T RTC may be selected taking into additional consideration the value of

[0157] In step S104, based on the judgment function selected in step S103, each administration event e i ~e k T Dose (e) is judged.

[0158] In one embodiment, the method comprises: Dose The determination of (e) may include step S90, i.e., transmitting at least a portion of the administration event records from the recording unit 11 to the receiving unit 71. In one embodiment, the method includes step S80, i.e., transmitting one or more administration events e1-e performed by the medical device having the recording unit 71, prior to the transmitting S90. z The step of recording information about the administration event in a dispensing event record may include:

[0159] The decision function f may be a function of the time information from the recording unit and the time information from the receiving unit.

[0160] In one embodiment, the decision function f is T Dose (e)=f(T Client , T RTC_trans , T Stamp (e)) may be used.

[0161] In one embodiment, the decision function f is a difference T between the time information from the receiving unit and the different time information from the recording unit. RTC_trans -T Stamp (e) function, e.g., T Dose (e)=f(T Client , (T RTC_trans -T Stamp (e))) It is okay.

[0162] In one embodiment, the decision function f is a function of the difference between the time information from the receiving unit and the time information from the recording unit, e.g., T Dose (e)=f(T Client , (T RTC_trance -T Stamp (e))) may be.

[0163] In one embodiment, the decision function f is T Dose (e)=T Client -(T RTC_trans -T Stamp (e)) may be used.

[0164] In one embodiment, the decision function g may be selected in S103 if the decision period does not contain any irregularities. This is exemplarily illustrated by the curves in Figure 2, where the x-axis represents the absolute time, e.g., UTC, to which the receiving unit is synchronized. The y-axis represents T RTC The vertical dotted line represents the value of T of the receiving unit 71, indicated by the label "BLE Sync" when at least a portion of the administration event record is received by the receiving unit 71. Client / T Client_p The cross on the curve indicates T Dose (e) is determined as an administration event e i ~e k In Figure 2, a portion of the administration event records starting from "First Use" to "Today" may be transmitted to be received by the receiving unit. The determination period may span between "First Use" and "Today".

[0165] In one embodiment, g also represents T Dose (e) The administration event for which the effect of T RTC If it was recorded after the last reset of T, it may be selected in S103. RTC The final reset of T occurs after the evaluation period ends. RTC There is no subsequent reset of T during the judgment period. RTC In other words, T RTC This is the case when there is no reset event between the last reset of the administration event record and the time when at least a portion of the administration event record is transmitted to be received by the receiving unit 71.

[0166] Referring to FIG. 3, this is indicated by the caption "BLE Sync" until the vertical dotted line, i.e., until the first part of the administration event record is received by the receiving unit 71, as indicated by the caption "ESD / Degradation."RTC After the reset of (i.e., T RTC = 0). In FIG. 3, the judgment period spans from "first use" to "today."

[0167] To refer to a specific part of the curve, the judgment period is divided into two parts, one is T RTC The part before the reset, i.e., the left part of the curve, and the other is T RTC The part after the reset, i.e., the part to the right of the curve, can be divided into

[0168] Since "BLE synchronization" is the first transmission of the administration event record, the change in variable Δ and T RTC The stored Δ can be used to determine the reset of pre In this scenario, there is no T RTC The determination of whether a reset has occurred is based on information stored in the administration event record, such as the T Stamp (e) of the subsequent administration event. Stamp If (e) does not increase, this is the T RTC Indicates a reset of

[0169] The decision function g is selected for all administration events in the second part, ie, the right part of the curve.

[0170] The judgment function g is a function of the time information from the recording unit 11 and the time information from the receiving unit 71, for example, T Dose (e)=g(T Client , T RTC_trans , T Stamp More specifically, the decision function g is the difference T RTC_trans -T Stamp (e) function, e.g., T Dose (e)=g( TClient , (T RTC_trans -T StampMore specifically, the determination function g may be the difference T RTC_trans -T Stamp (e) function, e.g., T Dose (e)=g(T Client , T RTC_trans -T Stamp (e))) In one embodiment, the decision function g is given by: T Dose (e)=T Client -(T RTC_trans -T Stamp (e))

[0171] The administration event e shown by the cross on the left side of the curve in Figure 3 left , i.e., for the first part of the decision period, the condition for selecting the decision function g is e left Between this and the end of the evaluation period, T RTC In other words, the absolute time T Dose (e left ) cannot be reliably determined by the decision function g.

[0172] However, in one embodiment, the administration event e left and a decision function i for all other recorded administration events in the first portion may be selected.

[0173] The decision function i is T Stamp (e), T User (e other ) and T Stamp (e other ) function. As mentioned above, T Stamp (e) is the administration event-related time information of the record unit indicating the time when the administration event e, the absolute time of which is to be determined, was recorded in the administration event record. User (e other ) is T Dose (e) is determined as the administration event e and the other administration event e recorded in the same part other In this context, the "same part" refers to the time between the administration event e and the administration event e otherRecord the administration event during T RTC This means that there is no irregularity or resetting of T (see, for example, the two dose events in Figure 6 between the two "ESD / Degradation" labels). Stamp (e other ) is the other administration event e other is administration event-related time information of the recording unit 11 indicating the time recorded in the administration event record.

[0174] In one embodiment, the decision function i is T User (e other ) and administration events e and e other is a function of the difference in administration event-related time information, and is given by the following equation: T Dose (e)=T User (e other )-T Stamp (e other )+T Stamp (e)

[0175] 5, the determination period spans a previous time point m when at least a portion of the administration event record is transmitted for reception by the receiving unit 71, and a subsequent time point m+1 when another portion of the administration event record is transmitted for reception by the receiving unit 71. The corresponding time information of the receiving unit 71 at which these portions of the administration event record are received is given by the subscripts p and p+1, respectively. In particular, T Client_p is the time of the receiving unit 71 indicating the time when at least a portion of the administration event record was received by the receiving unit 71 (see the "BLE Sync" label on the left side of Figure 5). Correspondingly, T Client_p+1 is the time of the receiving unit 71 indicating the time when the other parts of the administration event record were received by the receiving unit 71 (see the "BLE Sync" label on the right side of Figure 5).

[0176] The judgment period shown in Figure 5 is T RTC Furthermore, in the curve shown, T RTC is not its default value, e.g., zero, at the start of the evaluation period. However, T DoseTo determine (e), T RTC may be at its default value at the start of the evaluation period.

[0177] T indicated by the label "ESD / Degraded" RTC For the administration events recorded after the reset of T, the condition for selecting the decision function g is met. RTC For administration events recorded before the reset of , the condition for selecting decision function g is not met. For these administration events, decision function h is selected.

[0178] In other words, the decision function h is determined such that the decision period begins after the time p at which at least a portion of the administration event record is received by the receiving unit 71 and T Dose (e) The administration event e to be judged occurs during the judgment period T RTC If these conditions are met, the decision function h is selected even if T RTC may be selected at the start of the evaluation period without being its default value.

[0179] In one embodiment, the decision function h is pre and T Stamp (e) is a function of Δ pre is the time information from the recording unit, e.g., T RTC_m , and time information from the receiving unit, e.g., T Client_p Referring to the curve shown in FIG. pre is the formula: Δ pre =T Client_p -T RTC_m It may be judged according to

[0180] In one embodiment, the decision function h may correspond to the decision function l described below. The decision function h (or l) is T Dose (e)=Δ pre T Stamp (e)=T Client_p -T RTC_m +T Stamp (e) may be possible.

[0181] Referring to Figure 6, the difference from Figure 5 is that the curve shown is T RTC In other words, during the evaluation period, T RTC is reset twice. As mentioned above, T RTC For all administration events recorded before the first reset of T, a decision function h is selected. RTC For all administration events recorded since the last reset of g, a decision function g is selected.

[0182] In one embodiment, the above-mentioned decision function i is T Dose (e) The administration event e to be judged occurs during the judgment period T RTC nth reset of and T RTC In the example shown, n=1. Dose The administration event determined as (e) is shown in Figure 6 by two crosses between the "ESD / Degradation" label on the left and the "ESD / Degradation" label on the right. However, in one embodiment, a decision function i may be selected for all n > 1. According to decision function i, T Dose (e)=T Stamp (e other )-T Stamp (e other )+T Stamp (e) holds true.

[0183] In one embodiment, the decision function i may also be selected for all administration events that do not satisfy the conditions for selecting the decision function g or the decision function h. For example, this may be the first administration event for which the decision period is recorded in the administration event record (the administration event “e” in FIG. 3). left ") includes the administration event recorded before the first irregularity within the evaluation period.

[0184] In one embodiment, the decision function j is T DoseThe administration event for which (e) is judged is the first administration event recorded in the administration event record and the first irregularity during the judgment period, for example, the administration event “e” in FIG. left In one embodiment, the decision function j may be selected when the record is recorded between T Dose (e)=T RTC_FDE +T Stamp (e) holds true.

[0185] As outlined above, T RTC_FDE may be the first administration event time information of the recording unit indicating the time of the first administration event recorded in the administration event record by the recording unit 11. As outlined in the T overview, T RTC The initial value of T may be set according to absolute time, for example Coordinated Universal Time (UTC), during the manufacture of the recording unit. RTC The initial value of T may be set to correspond to the absolute time when the timer starts running, for example, the moment the recording unit is connected to an energy source during assembly. RTC_FDE is the time T at the moment the first administration event is recorded in the administration event record. RTC may correspond to the value of

[0186] In one embodiment shown in FIG. RTC If there is no reset of T, the decision function k may be selected. RTC If k is not a default value, then the decision function k may be selected. This is illustrated by the injection event between the two “BLE Sync” labels in Figure 4.

[0187] In one embodiment, according to the decision function k, T Dose (e)=T Client_p+1 -(T RTC_m+1 -T Stamp (e))*CF holds true.

[0188] In the determination function k, CF is a correction factor. The 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 may be determined according to the following formula:

number

[0189] As mentioned above, T RTC_m is the transmission-related time information of the recording unit indicating the first time point m when at least a first portion of the administration event record was transmitted to be received by the receiving unit. RTC_m is the transmission-related time information of the recording unit indicating the second time point m+1 at which at least a second portion of the administration event record was transmitted to be received by the receiving unit. Client_p is the time information of the receiving unit indicating the third time point p when the first portion of the administration event record was received by the receiving unit (see the "BLE Sync" label on the left side of FIG. 4). In one embodiment, the third time point may be earlier than the second time point, not shown, but slightly before the "BLE Sync" label on the right side of FIG. 4. T Client_p+1 is the time information of the receiving unit indicating the fourth point in time p+1 when the second part of the administration event record was received by the receiving unit (see the "BLE Sync" label on the right side of Figure 4).

[0190] 7 schematically illustrates an apparatus 10 for a medical device according to one embodiment of the present disclosure. The apparatus 10 includes a recording unit 11, a storage unit 12, an energy source 13, and a transmitting unit 14. The recording unit is configured to record information about one or more administration events performed by the medical device in an administration event record.

[0191] The recording unit 11 includes a timer configured to provide time information of the recording unit, the time information being T RTCThe storage unit 12 is configured to record administration event records. The storage unit 12 may form part of a recording unit. The energy source 13 is configured to provide electrical energy to the recording unit 11 and / or the storage unit 12 and / or the transmitting unit 14.

[0192] In one embodiment, the device 10 is configured to be attachable to a medical device 60, such as a medication delivery device, as shown in Figure 9. As shown, the device 10 is configured to be attachable to a dose setting unit 20 of the medical device 60 such that a user can perform a dosing event on the medical device 60 via the device 10.

[0193] In one embodiment, the device 10 may be attachable to one or more of a dose setting unit, an activation mechanism, a release unit and / or a housing of a medical device.

[0194] As shown in FIGS. 2-6, in one embodiment, when the first administration event is recorded in the administration event record, T RTC The value of may be set to the default value, i.e., zero. Alternatively, as described in the summary above, T RTC The default value of may be different from zero.

[0195] The sending unit 14 sends at least a portion of the administration event record and the associated time information T RTC_trans to the receiving unit 71. The transmission-related time information indicates the time at which at least a portion of the administration event record including the administration event e was transmitted to be received by the receiving unit 71. The receiving unit 71 may be part of the administration event processing device 70 (see FIG. 8).

[0196] 8 is a schematic diagram of an administration event processor 70 according to one embodiment of the present disclosure. The administration event processor 70 stores one or more recorded administration events e1-e performed by a medical device. z Absolute time T Dose (e), where e is one or more administration events e1 to ez The administration event is recorded in the administration event record.

[0197] The administration event processing device 70 processes one or more recorded administration events e1 to e z The administration event processing device 70, more specifically its processing unit 72, processes one or more recorded administration events e1 to e recorded in the received portion of the administration event record. z Absolute time T Dose It is configured to determine (e).

[0198] In one embodiment, the administration event processing device 70, more particularly its processing unit 72, is configured to perform a method according to one of the paragraphs above and / or summaries above.

[0199] The administration event processing device 70 further includes a user interface 73 operatively connected to the receiving unit 71 and the processing unit 72. The user interface 73 is configured to receive user input. In particular, the user input may be a selected set of determination periods in the received portion of the administration event record.

[0200] In one embodiment, the dispensing event processor 70 may be a mobile device, such as a smartphone.

[0201] The administration event processing device 70 processes one or more recorded administration events e1 to e z Absolute time T Dose The decision function for a particular administration event e, which is configured to decide (e) based on a decision function, may be, as described in the paragraph above and in the summary above, based on the occurrence of irregularities in the time information of the received portion of the administration event record, e.g., T RTC and the timestamp T of a particular administration event e in response to the reset of Stamp(e) is taken into consideration when selecting.

[0202] In one embodiment, the decision function g is set to a value that is greater than or equal to T Dose (e) The administration event e to be judged is T RTC Selected if recorded since the last reset of T RTC The final reset of T occurs after the evaluation period ends. RTC There is no subsequent reset of T during the judgment period. RTC This is a reset.

[0203] The occurrence of irregularity is assessed based on detecting a change in the variable Δ as described in the paragraph above and in the summary above. Alternatively, or additionally, the occurrence of irregularity is assessed based on detecting a change in the variable Δ as described in the paragraph above and in the summary above. Stamp may be evaluated based on the value of (e).

[0204] Alternatively, or in addition, the decision function h is determined such that the decision period is T RTC If the determination period begins after the time p at which at least a portion of a given administration event record is received by the receiving unit 71, T Dose (e) The administration event to be judged occurs during the evaluation period. RTC This is selected if the data was recorded before the first reset of the

[0205] Alternatively, or additionally, decision function i is selected if neither the conditions for selecting g or h are met. For example, i is T Dose (e) is judged by the administration event e, and T RTC nth reset of and T RTC This may be selected if the data was recorded during the n+1th reset of the previous time.

[0206] In one embodiment, the decision function is: T Dose (e)=g(T Client -(T RTC_trans -T Stamp (e))), and / or TDose (e)=h(Δ pre +T Stamp (e)), and / or T Dose (e)=i(T User (e other )-T Stamp (e other )+T Stamp (e)) may be a)T Stamp (e) is the administration event related time information of the recording unit 11 indicating the time when the administration event e was recorded in the administration event record; b) T RTC_trans is transmission-related time information of the recording unit 11 indicating the time at which at least a portion of the administration event record was transmitted to be received by the receiving unit 71; c)T RTC_m is transmission-related time information of the recording unit 11 indicating the time at which at least a portion of the administration event record was transmitted to be received by the receiving unit 71; d) T Client is time information from the receiving unit 71 indicating the time at which at least a portion of the administration event record was received by the receiving unit 71; e)T Client_p is time information from the receiving unit 71 indicating the time p at which at least a portion of the administration event record was received by the receiving unit 71; f)Δ pre is calculated based on the time information from the recording unit 11 and the time information from the receiving unit 71, for example, T RTC_m and T Client_p is a variable indicating the time lag between the recording unit 11 and the receiving unit 71, determined based on g)T User (e other ) is the other administration event e recorded in the administration event record in the same judgment period portion as administration event e other is the user input time, h)T Stamp (e other ) is the other administration event e otheris administration event related time information of the recording unit 11 indicating the time recorded in the administration event record.

[0207] In one embodiment, g, h, and i are functions of the variables and / or formulas specified within the brackets.

[0208] In one embodiment, the decision function is: T Dose (e)=g(T Client -(T RTC_trans -T Stamp (e))), and / or T Dose (e)=j(T RTC_FDE +T Stamp (e)), and / or T Dose (e)=k(T Client_p+1 -(T RTC_m+1 -T Stamp (e))*CF), and / or T Dose (e)=l(T Client_p -(T RTC_m -T Stamp (e))) And, a)T Stamp (e) is the administration event related time information of the recording unit 11 indicating the time when the administration event e was recorded in the administration event record; b) T RTC_trans is transmission-related time information of the recording unit 11 indicating the time at which at least a portion of the administration event record was transmitted to be received by the receiving unit 71; c)T RTC_m is the transmission-related time information of the recording unit 11 indicating a first time point m at which at least a portion of the administration event record is transmitted to be received by the receiving unit 71; d) T RTC_FDE is the first administration event time information of the recording unit 11 indicating the time when the first administration event was recorded in the administration event record; e)T RTC_m+1is the transmission-related time information of the recording unit 11 indicating a second time point m+1 at which at least a second part of the administration event record was transmitted to be received by the receiving unit 71, the second time point m+1 being the time point at which a first part of the administration event record was transmitted to be received by the receiving unit; f)T Client is time information from the receiving unit 71 indicating the time at which at least a portion of the administration event record was received by the receiving unit 71; g)T Client_p is time information from the receiving unit 71 indicating a third time point p at which at least a portion of the administration event record was received by the receiving unit 71; h)T Client_p+1 is time information of the receiving unit 71 indicating a fourth time point p+1 at which the second part of the administration event record was received by the receiving unit 71, the fourth time point p+1 being a time point later than the third time point p at which the first part of the administration event record was received by the receiving unit; i) CF is a correction coefficient, that is, a function of the time information from the recording unit 11 and the time information from the receiving unit 71, and is given by, for example, the following equation:

number

[0209] 9 is a schematic diagram of a medical device 60 according to one embodiment of the present disclosure. The illustrated medical device 60 is a drug delivery device including a device 10, a dose setting unit 20, and a dose ejection unit. The dose ejection unit is housed in a housing 30. The device 10 is removably attached to the dose setting unit 20 of the drug delivery device.

[0210] The dose setting unit 20 is configured to set the dose to be expelled in a dose setting operation. The dose setting unit 20 is operatively connected to the dose ejection unit such that the set dose can be expelled from the medication delivery device in a dose ejection operation.

[0211] The device 10 is configured to record administration events performed by the medical device in an administration event record. The device 10 may be a device described in the paragraph above and / or in the summary above.

[0212] The dose ejection unit includes a drive unit 31 and a plunger 32 .

[0213] The drug delivery device further includes a drug container 40 having an interior space 42 for containing the drug, and a stopper 41 movable within the interior space 42 when moved distally to expel the drug from the drug container.

[0214] The drive unit 31 is configured to provide a force that axially moves the plunger 32. The plunger 32 is configured to transmit the movement driven by the force of the drive unit 31 to the stopper 41 of the drug container 40, thereby moving the stopper 41 within the internal space 42.

[0215] In one embodiment, the plunger 32 may be configured such that its distal end forms a stopper for the medication container, i.e., the distal end of the plunger 32 may be configured to move within the interior space when moved distally, thereby expelling the medication therefrom.

[0216] In one embodiment, the drive unit may be a mechanism that transfers drive energy from a user to the plunger.

[0217] In one embodiment, the drive unit may be a drive spring, which may be pre-tensioned or may be tensioned in situ in response to user manipulation of the medical device.

[0218] 9, 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.

[0219] In one embodiment, the medical device may be a drug delivery device. In one embodiment, the drug delivery device may be a device that allows a user to set a variable dose, a so-called variable dose device. In one embodiment, the drug delivery device may be a syringe. In one embodiment, the drug delivery device may be a pen-type device.

[0220] One embodiment of the present disclosure, not shown, relates to a computer program product including machine-readable instructions that, when executed by a processing unit, cause an administration event processor to process one or more recorded administration events e1-e performed by a medical device. z Absolute time T Dose (e) performing a method for determining the administration event processor. The administration event processor may be an administration event processor 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.

[0221] One embodiment of the present disclosure, not shown, relates to a computer-readable storage medium, e.g., a non-transitory computer-readable storage medium, having stored thereon a computer program product including machine-readable instructions that, when executed by a processing unit, cause a dosing event processor to process one or more recorded dosing events e1-e performed by a medical device. z Absolute time T Dose (e) The computer program product may be a computer program product according to an embodiment or aspect of the present disclosure.

[0222] One embodiment of the present disclosure, not shown, relates to a computer-readable storage medium, e.g., a non-transitory computer-readable storage medium, having stored thereon a computer program product including machine-readable instructions that, when executed by a processing unit of an administration event processor, cause the administration event processor to record one or more recorded administration events e1-e performed by a medical device. z Absolute time T Dose The method is performed to determine (e), where e characterizes a particular administration event and the subscript z is a positive integer.

[0223] In one embodiment, the method may be a method according to an embodiment or aspect of the present disclosure.

[0224] In one embodiment, the administration event processor may be an administration event processor according to an embodiment or aspect of the present disclosure.

[0225] As noted in the Summary, the terms "drug" or "medicament" are used synonymously herein to refer to a pharmaceutical formulation containing one or more pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and, optionally, a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that exerts a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease, or otherwise improve physical or mental well-being. Drugs or medications may be used for a limited period of time or periodically for chronic conditions.

[0226] As described below, drugs or pharmaceutical agents may contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with 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, as well as nucleic acids, double- 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 may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0227] The drug or agent may be contained in a primary package or "drug container" adapted for use with the drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other rigid or flexible container configured to provide a suitable chamber for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store the drug for at least one day (e.g., from one to at least 30 days). In some instances, the chamber may be designed to store the drug for about one month to about two years. Storage may occur at room temperature (e.g., about 20°C) or refrigerated temperature (e.g., about -4°C to about 4°C). In some instances, the drug container may be or 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), one in each chamber. In such examples, the two chambers of the dual-chamber cartridge may be configured to allow mixing of two or more components prior to and / or during injection into the human or animal body. For example, the two chambers may be configured to be in fluid communication with each other (e.g., by a conduit between the two chambers), allowing the two components to be mixed if desired by a user prior to injection. Alternatively, or additionally, the two chambers may be configured to allow mixing upon injection of the components into the human or animal body.

[0228] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs include, but are not limited to, those described in handbooks such as Roterist 2014, Main Group 12 (antidiabetic drugs) or 86 (oncology drugs), and the Merck Index, 15th Edition.

[0229] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include insulin, e.g., human insulin, or an insulin analog or derivative; glucagon-like peptide (GLP-1); a GLP-1 analog or GLP-1 receptor agonist; or an analog or derivative thereof; a dipeptidyl peptidase-4 (DPP4) inhibitor; or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deleting and / or substituting at least one amino acid residue present in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or substituted amino acid residue may be either a codable amino acid residue or another naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from that of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may be deleted and / or substituted with other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, may be added to the naturally occurring peptide. Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine), Lys(B3), Glu(B29) human insulin (insulin glulisine), Lys(B28), Pro(B29) human insulin (insulin lispro), Asp(B28) human insulin (insulin aspart), human insulin in which the proline in position B28 may be substituted with Asp, Lys, Leu, Val or Ala and the Lys in position B29 may be substituted with Pro, Ala(B26) human insulin, Des(B28-B30) human insulin, Des(B27) human insulin and Des(B30) human insulin.

[0230] Examples of insulin derivatives include B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®), B29-N-palmitoyl-des(B30) human insulin, B29-N-myristoyl human insulin, B29-N-palmitoyl human insulin, B28-N-myristoylLysB28ProB29 human insulin, B28-N-palmitoyl-LysB28ProB29 human insulin, and B30-N-myristoyl-ThrB29LysB30 human insulin. Examples of insulin include B29-N-palmitoyl-ThrB29LysB30 human insulin, B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®), B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin, B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin, and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0231] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide), HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, These include 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.

[0232] An example of an oligonucleotide is mipomersen sodium (Kynamro®), a cholesterol-lowering antisense drug for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome.

[0233] Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0234] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin, and their antagonists.

[0235] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or derivatives thereof, or sulfated forms of the above polysaccharides, such as polysulfated forms, and / or pharmaceutically acceptable salts thereof. 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 GF 20 (Synvisc®), sodium hyaluronate.

[0236] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigen. An antibody may be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human antibody (e.g., a murine antibody), or a single-chain antibody. In some embodiments, an antibody has effector function and can fix complement. In some embodiments, an antibody has reduced or no ability to bind to Fc receptors. For example, an antibody may be an isotype or subtype, antibody fragment, or mutant that does not support binding to Fc receptors, e.g., with mutations or deletions in the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins with a crossover binding region orientation (CODV).

[0237] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments may include truncated portions of the full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, and tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunotherapeutics (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0238] The term "complementarity-determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences but are primarily responsible for maintaining the proper orientation of the CDR sequences to enable antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of a particular antibody may be directly involved in antigen binding or may influence the ability of one or more amino acids in the CDRs to interact with the antigen. Examples of antibodies include anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0239] Pharmaceutically acceptable salts of any API described herein are also contemplated for use with the drug or agent in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0240] Those skilled in the art will understand that modifications (additions and / or removals) of various elements of the APIs, formulations, devices, methods, systems, and embodiments described herein may be made without departing from the full scope and spirit of the present invention, including such modifications and any and all equivalents thereof. An exemplary drug delivery device may include 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 may be broadly categorized into multi-dose container systems and single-dose (partial or full discharge) container systems. The container may be an interchangeable container or an integrated, non-interchangeable container.

[0241] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle injection device with replaceable containers. In such systems, each container holds multiple doses of fixed or variable size (pre-set by the user). Another multi-dose container system may include a needle injection device integrated with a non-replaceable container. In such systems, each container holds multiple doses of fixed or variable size (pre-set by the user).

[0242] As further described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with replaceable containers. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable amount (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable amount (partial discharge). Also as described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with an integrated, non-replaceable container. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable amount (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable amount (partial discharge).

[0243] It should be understood that all features and parts described with respect to aspects in the summary can be used in the embodiments described in this section, even if not all of these combinations are explicitly mentioned. [Explanation of symbols]

[0244] 10 equipment 11 Recording Unit 12 Storage Units 13 Energy Sources 14 Transmitting unit 20 dose titration units 30 Case 31 Drive unit 32 Plunger 40 Medicine container 41 Stopper 42 Interior Space 50 stitches 51 Cap 60 Medical Devices 70 Administration Event Processing Device 71 Receiving unit 72 Processing Unit 73 User Interface S80 Record administration events in the Administration Event Record S90 Send administration event record to receiving unit S100 Receive administration event records S101: Define the judgment period S102 Evaluate the time information of administration event records within the evaluation period S103 Select the judgment function S104 Determine the absolute time of the recorded administration event

Claims

1. one or more recorded administration events e performed by the medical device; １ ~e ｚ Absolute time or standard time T Ｄｏｓｅ (e), wherein e characterizes a particular administration event; the one or more administration events are recorded in an administration event record; At least a portion of the administration event record is received (S100) or receivable by a receiving unit (71); and determining T based on at least one time information from the recording unit (11) that recorded the administration event in the administration event record and at least one time information from the receiving unit (71). Ｄｏｓｅ (e) is determined (S104).

2. a) the time information from the recording unit (11), administration event related time information T of said recording unit (11) indicating the time when said administration event (e) was recorded in said administration event record; Ｓｔａｍｐ (e), and transmission-related time information T of the recording unit (11) indicating the time at which at least a portion of the administration event record was transmitted for reception by the receiving unit (71); ＲＴＣ＿ｔｒａｎｓ and / or b) the time information from the receiving unit (71) indicates the time T of the receiving unit (71) that indicates the time when at least a portion of the administration event record was received by the receiving unit (71); Ｃｌｉｅｎｔ 10. The method of claim 1, comprising:

3. At least a portion of the administration event records include, for each administration event, a unique administration event identifier, a dose, and a T value of the recording unit (11). Ｓｔａｍｐ The method of any one of claims 1 to 2, including information relating to at least one, or any selected plurality, or all of (e).

4. The recording unit includes a timer configured to provide time information to the recording unit (11), and the time information is T ＲＴＣ The method according to any one of claims 1 to 3, wherein

5. The method further includes a step (S101) of defining a determination period for at least a portion of the administration event records, the determination period being T Ｄｏｓｅ One or more administration events (e) are determined ｉ ~e ｋ ), wherein k≧i≧1, and the one or more administration events (e ｉ ~e ｋ ) the absolute or standard time T of a specific administration event (e) Ｄｏｓｅ The method of any one of claims 1 to 4, wherein (e) is determined using a decision function.

6. 6. The method of claim 5, wherein the determination period is selectable or selected by a user, for example via a user interface (73).

7. the judgment function f is a function of the time information from the recording unit (11) and the time information from the receiving unit (71), T Ｄｏｓｅ (e) = f(T Ｃｌｉｅｎｔ , T ＲＴＣ＿ｔｒａｎｓ , T Ｓｔａｍｐ (e)), or T Ｄｏｓｅ (e) = f(T Ｃｌｉｅｎｔ , (T ＲＴＣ＿ｔｒａｎｓ -T Ｓｔａｍｐ (e)), or T Ｄｏｓｅ (e) = f(T Ｃｌｉｅｎｔ , (T ＲＴＣ＿ｔｒａｎｓ -T Ｓｔａｍｐ (e)), or T Ｄｏｓｅ (e) = T Ｃｌｉｅｎｔ - (T ＲＴＣ＿ｔｒａｎｓ -T Ｓｔａｍｐ 7. A method according to claim 5 or 6, wherein (e)) and with additional reference to claim 2.

8. A method according to any one of claims 1 to 7, further comprising the step of evaluating (S102) at least a portion of the administration event record for the occurrence of irregularities in the time information contained in at least a portion of the administration event record.

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

10. The irregularity results in the timer of the recording unit (11) being reset. ＲＴＣ T ＲＴＣ 10. The method according to claim 8 or 9, wherein the event of resetting the recording unit (11) is a change of the value of the recording unit (11) to a predetermined value, for example zero.

11. The occurrence of irregularities is evaluated based on the detection of a change in a variable Δ, Δ being a function of the time information from the recording unit (11) and the time information from the receiving unit (71), for example, Δ is T ＲＴＣ＿ｍ and T Ｃｌｉｅｎｔ＿ｐ a function of, preferably Δ=T Ｃｌｉｅｎｔ＿ｐ -T ＲＴＣ＿ｍ and a) T ＲＴＣ＿ｍ is transmission-related time information of the recording unit (11) indicating the time (m) at which at least a portion of the administration event record was transmitted to be received by the receiving unit (71), b) T Ｃｌｉｅｎｔ＿ｐ is time information from the receiving unit (71) indicating the time (p) at which at least part of the administration event record was received by the receiving unit (71).

12. The judgment function for the particular administration event (e) is selectable or selected from a plurality of different judgment functions depending on the occurrence of the irregularity in the time information of the at least part of the administration event record during the judgment period (S103). A method as claimed in any one of claims 8 to 11 and with additional reference to claims 5 to 6.

13. a) If the judgment period does not include irregularities, or T Ｄｏｓｅ (e) The administration event for which determination is made is T during the determination period. ＲＴＣ The decision function g is selected when the value recorded after the last reset of T ＲＴＣ The final reset of T ＲＴＣ T during the determination period without subsequent reset of ＲＴＣ and / or b) the determination period begins after the time (p) at which at least a portion of the administration event record is received by the receiving unit, and further Ｄｏｓｅ The administration event (e) for which (e) is determined occurs within the determination period T ＲＴＣ The decision function h is selected when the value of c) In any other case, e.g., T Ｄｏｓｅ (e) The administration event for which determination is made is T ＲＴＣ 13. The method of claim 12, wherein the decision function i is selected when the value of the n-th reset and the (n+1)-th reset (n≧1) are recorded.

14. T Ｄｏｓｅ (e) = g(T Ｃｌｉｅｎｔ - (T ＲＴＣ＿ｔｒａｎｓ -T Ｓｔａｍｐ (e))), and / or T Ｄｏｓｅ (e) = h(Δ ｐｒｅ +T Ｓｔａｍｐ (e)), and / or T Ｄｏｓｅ (e)=i(T Ｕｓｅｒ (e ｏｔｈｅｒ )-T Ｓｔａｍｐ (e ｏｔｈｅｒ )+T Ｓｔａｍｐ (e)) And, a) T Ｓｔａｍｐ (e) is administration event-related time information of the recording unit (11) indicating the time when the administration event (e) was recorded in the administration event record; b) T ＲＴＣ＿ｔｒａｎｓ is transmission-related time information of the recording unit (11) indicating the time at which at least a portion of the administration event record was transmitted to be received by the receiving unit (71); c) T ＲＴＣ＿ｍ is transmission-related time information of the recording unit (11) indicating the time (m) at which at least a portion of the administration event record was transmitted to be received by the receiving unit (71), d) T Ｃｌｉｅｎｔ is time information from the receiving unit (71) indicating the time at which at least a portion of the administration event record was received by the receiving unit (71), e) T Ｃｌｉｅｎｔ＿ｐ is time information from the receiving unit (71) indicating the time (p) at which at least a portion of the administration event record was received by the receiving unit (71), f) Δ ｐｒｅ However, based on the time information from the recording unit (11) and the time information from the receiving unit (71), for example, T ＲＴＣ＿ｍ and T Ｃｌｉｅｎｔ＿ｐ a variable indicating a time lag between the recording unit (11) and the receiving unit (71), determined based on g) T Ｕｓｅｒ (e ｏｔｈｅｒ ) is recorded in the administration event record in the same judgment period portion as the administration event (e) ｏｔｈｅｒ ) is the user input time, h) T Ｓｔａｍｐ (e ｏｔｈｅｒ ) is the other administration event (e ｏｔｈｅｒ administration event related time information of the recording unit (11) indicating the time at which the administration event was recorded in the administration event record, 14. The method of claim 13, wherein g, h, and i are functions of the variables and / or formulas specified within the parentheses.

15. The judgment function for the particular administration event (e) is determined depending on the occurrence of irregularity in the time information of at least a part of the administration event record during the judgment period, and / or depending on whether the judgment period is T ＲＴＣ A selection can be made from a plurality of different decision functions depending on whether the process starts from a reset of the a) The judgment period is T ＲＴＣ If it starts from a reset of T and does not contain any irregularities, or Ｄｏｓｅ (e) The administration event e for which the determination is made is T ＲＴＣ The decision function g is selected when the value recorded after the last reset of T ＲＴＣ The final reset of T ＲＴＣ T during the determination period without subsequent reset of ＲＴＣ and / or b) T Ｄｏｓｅ a decision function j is selected if the administration event e for which (e) is determined is recorded between a first administration event recorded in an administration event record and a first irregularity during the decision period; and / or c) T during the said determination period. ＲＴＣ The decision function k is selected when there is no reset of d) the decision function l is selected if the decision period begins after the time (p) at which at least a portion of the administration event record is successfully received by the receiving unit (71); and T Ｄｏｓｅ The administration event (e) is determined to occur within the determination period. ＲＴＣ Selected if recorded before the first reset of T ＲＴＣ The first reset of T ＲＴＣ There is no prior reset of T ＲＴＣ 12. A method according to any one of claims 8 to 11 and additionally referred to in claim 5 or 6, which is a reset of

16. T Ｄｏｓｅ (e) = g(T Ｃｌｉｅｎｔ - (T ＲＴＣ＿ｔｒａｎｓ -T Ｓｔａｍｐ (e))), and / or T Ｄｏｓｅ (e) = j(T ＲＴＣ＿ＦＤＥ +T Ｓｔａｍｐ (e)), and / or T Ｄｏｓｅ (e) = k(T Ｃｌｉｅｎｔ＿ｐ＋１ - (T ＲＴＣ＿ｍ＋１ -T Ｓｔａｍｐ (e)) *CF), and / or T Ｄｏｓｅ (e) = l(T Ｃｌｉｅｎｔ＿ｐ - (T ＲＴＣ＿ｍ -T Ｓｔａｍｐ (e))) a) T Ｓｔａｍｐ (e) is administration event-related time information of the recording unit (11) indicating the time when the administration event (e) was recorded in the administration event record; b) T ＲＴＣ＿ｔｒａｎｓ is transmission-related time information of the recording unit (11) indicating the time at which at least a portion of the administration event record was transmitted to be received by the receiving unit (71); c) T ＲＴＣ＿ｍ is transmission-related time information of the recording unit (11) indicating a first time point (m) at which at least a portion of the administration event record is transmitted to be received by the receiving unit (71), d) T ＲＴＣ＿ＦＤＥ is the first administration event time information of the recording unit (11) indicating the time when the first administration event was recorded in the administration event record; e) T ＲＴＣ＿ｍ＋１ is the transmission-related time information of the recording unit (11) indicating a second time point (m+1) at which at least a second portion of the administration event record was transmitted to be received by the receiving unit (71), the second time point (m+1) being a time point subsequent to the first time point (m) at which a first portion of the administration event record was transmitted to be received by the receiving unit; f) T Ｃｌｉｅｎｔ is time information from the receiving unit (71) indicating the time at which at least a portion of the administration event record was received by the receiving unit (71), g) T Ｃｌｉｅｎｔ＿ｐ is time information from the receiving unit (71) indicating a third time point (p) when at least a portion of the administration event record was received by the receiving unit (71), h) T Ｃｌｉｅｎｔ＿ｐ＋１ is time information of the receiving unit (71) indicating a fourth time point (p+1) at which the second part of the administration event record was received by the receiving unit (71), the fourth time point (p+1) being a time point after a third time point (p) at which the first part of the administration event record was received by the receiving unit; i) CF is a function of the time information from the recording unit (11) and the time information from the receiving unit (71), e.g. [Equation 1] A correction coefficient that is 16. The method of claim 15, wherein g, j, k, and l are functions of the variables and / or formulas specified within the parentheses.

17. a) T Ｄｏｓｅ and / or the method comprises, prior to determining (e), a step (S90) of transmitting at least a portion of the administration event record from the recording unit (11) to the receiving unit (71); b) prior to transmitting (S90) at least a portion of said administration event record, said method further comprises recording one or more administration events (e) performed by a medical device having a recording unit (71). １ ~e ｚ 17. The method of any one of claims 1 to 16, comprising the step (S80) of recording information about the administration event in a dosing event record.

18. One or more recorded administration events (e) performed by the medical device １ ~e ｚ ) absolute time or standard time T Ｄｏｓｅ an administration event processor (70) for determining (e), wherein e characterizes a particular administration event of the one or more administration events, and wherein the administration event processor (70) a receiving unit (71) configured to receive at least a portion of the administration event record; and a processing unit (72), An apparatus (70) wherein said administration event processing unit (70) is configured to perform the method of any one of claims 1 to 17.

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

20. A computer readable storage medium, e.g. a non-transitory computer readable storage medium, having stored thereon a computer program product comprising machine readable instructions which, when executed by the processing unit (72), cause a dosing event processing device (70) according to claim 18 or 19 to perform or control a method according to any one of claims 1 to 17.

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