JP2019080931A - Logging device adapted to combine doses - Google Patents

Abstract

To provide a drug delivery system comprising means to create a log of expelled doses of drug.SOLUTION: Recorded doses determined within a given time period are combined into a single combined dose. The given time period is initiated by either (i) detecting an expelling event occurring after the elapse of the given time period from a preceding expelling event detected previously or (ii) detecting an expelling event occurring after a given detected action. This arrangement makes it possible to create a log corresponding to what a user considers to be a single dose, i.e., makes it possible to combine "split doses" to create a single log entry for each per se split dose.SELECTED DRAWING: Figure 1A

Description

  The present invention relates generally to medical devices that generate, collect and store data. In certain embodiments, the present invention relates to devices and systems for acquiring and managing drug delivery dose data in an efficient and user-friendly manner.

  In the present disclosure, in most cases, reference is made to a drug delivery device comprising a threaded piston rod driven by a rotary drive member, such device being used, for example, for the treatment of diabetes by delivery of insulin. This is only an exemplary use of the present invention.

  Drug injection devices have greatly improved the lives of patients who have to self-administer drugs and biologics. The drug injection device can take many forms and is durable from being like a simple disposable device only as an ampoule with injection means, or to be used in combination with a pre-filled cartridge. It may be an apparatus. Regardless of the form or type, so far, drug injection devices have been shown to be a great aid in patients self-administering injectable drugs and biologics. The drug injection device also greatly assists the caregiver in administering the injectable drug to people who can not perform self-injection.

  Conducting the required insulin injections in the correct size at the correct time is a critical part of managing diabetes, ie it is important to adhere to a specific insulin regimen. It is recommended that patients with diabetes have a log of each injection's size and time in order to allow medical personnel to determine the effects of prescribed dosing patterns. However, since such diaries are usually written on handwritten notes, the written information can not be easily uploaded to a computer for data processing. Furthermore, because only the events that can be written down by the patient are described, the patient will not forget to describe each injection in order to make the described information of any value in the treatment of the patient's illness. That is required on the note system. Forgetting a record or a wrong record can mislead the injection history and thus mislead the information underlying the medical practitioner's decisions regarding future drug treatment. Therefore, it is desirable to automate the description of injection information from the drug delivery system.

  Some injection devices integrate the monitoring / acquisition mechanism as disclosed in, for example, US2009 / 0318865 into the device itself, but most devices today do not. The most widely used devices are either durable or pre-filled purely mechanical devices. Since the latter device is inexpensive so as to be thrown away when emptying, incorporating the electronic data acquisition function into the device itself is not cost effective. Several solutions have been presented to address this problem and to help users generate, collect and distribute data indicative of the use of a given medical device.

  For example, WO 2007/107564 discloses an electronic "add-on" module mounted on a standard mechanical pen-type device and measuring the signal generated thereby, said module operating, for example, from the device Depends on the specific voice generated from time to time.

  Alternatively, such pre-filled drug delivery device can be modified to provide a pre-loaded drug delivery device that can reliably detect that the drug dose is "out of dose". By appropriately co-operating with the above, it is possible to increase the reliability and certainty of the determination of the dose outside the dose. For example, in the drug delivery device disclosed in PCT / EP2012 / 069729, the rotary piston rod is provided with a magnet so that the add-on logging module can detect the axial position of the magnet with a 3D magnetometer.

  In view of the above, it is an object of the present invention to provide a system, apparatus and method for acquiring and managing drug delivery dose data in an efficient and user friendly manner.

  In the present disclosure, embodiments and aspects are described which address one or more of the above-mentioned objects, or which address the objects disclosed in the following disclosure and examples of the embodiments.

  According to a first aspect of the present invention, there is provided a logging device removably mounted on a drug delivery device, the drug delivery device comprising a drug reservoir or a drug reservoir containing means and a user of a dose of drug to be discharged. And a drug delivery means comprising dose setting means which allows setting, the logging device comprising electronic circuitry for creating a log of the dose of drug delivered. The electronic circuit generates sensor means for acquiring an attribute value related to the dose of the medicine discharged from the reservoir by the discharge means during the discharge event, processor means for determining the dose based on the acquired attribute value, and a log Storage means for storing a plurality of doses in order to Each stored dose measured within a given time period can be summed or summed into a single combined dose. It should be noted that the given period is started after a certain period has elapsed from the previously detected preceding discharge event or when a discharge event is detected after the given action detected.

  When a plurality of doses are defined as being stored, each dose is stored, for example, as an attribute value of the dose obtained as it is or as a calculated value of the dose. The term "ejection event" refers to the first state in which the ejection means are operating (eg, by release of the drive spring, actuation of the electric motor, or depression of the drive button) to initiate drug ejection, It is a discharge of the medicine which has occurred until the 1st following state which operation stops or stops. The drug will continue to be delivered for a short period of time after the end of a given event due to the elasticity of the system.

  When taking a dose of a given size, the dose may be divided by the user, for example, if the dose is large or it requires replacement of the cartridge. If an electronic logging device is provided, the result is a log of two entries, despite the user considering this dose as a single dose. With the above configuration, it is possible to create a log corresponding to what the user considers to be a single dose (that is, a single log entry for essentially divided doses added up "divided doses") Become. As will be appreciated, each of the individual "fractionated doses" represents an exhalation event.

  If it is detected that there has been more than one administration within a given time period, then these doses may be automatically summed up, or for more than one administration detected within a given time period Alternatively, the user may be asked whether the addition should be performed. If a dose below a given value (for example, 2 units or 3 units of insulin) is detected, the administration is judged to be priming or blanking, and is not stored as a log entry, or is not added It is not an object of Even when the combined dose is calculated and stored, the individual doses may be stored and may be read out later as appropriate. Time values may be associated with each stored dose. For example, a first time value may be used for the summed dose.

  The logging device may comprise a display controlled by the electronic circuitry and displaying the stored data. For example, log entries may be shown as drug amounts with time values. The time may be an actual time value or may be the time since a given dose has been stored. The summed quantities may be displayed as such. Additionally or alternatively, the electronic circuitry may comprise transmitter means, for example to transmit data stored using NFC means to an external receiver.

  In an exemplary embodiment, the sensor means acquires an attribute value in the form of an amount of rotation of the magnetic means disposed in the drug delivery device, the amount of rotation of the magnetic means being of the agent discharged from the reservoir by the discharge means. Correspond to the quantity.

  The logging device described above may be provided in combination with a drug delivery device to form a drug delivery system, the drug delivery device comprising a drug reservoir or drug reservoir containing means, as well as a drug delivery means, the logging device comprising It is removably attachable to the drug delivery device.

  The system further comprises a cap removably attachable to the drug delivery device and covering the outlet portion of the drug reservoir, and the logging device detects that the cap is mounted, thereby mounting the cap Condition that the doses detected since the ongoing period has ended and the period has begun are summed up.

  In an exemplary embodiment, the drug delivery device further comprises an identifier in the form of color or barcode, for example, representing information about the particular drug type or the particular drug delivery device contained in the reservoir, and the logging device , And means for obtaining information from the identifier, wherein the electronic circuit creates a log for the given identifier.

  According to a further aspect of the present invention, a drug reservoir or a drug reservoir storage means, a drug discharge means comprising a dose setting means enabling the user to set a dose of the drug to be discharged, and a discharged A drug delivery system is provided, comprising an electronic circuit that produces a log of the dose of drug. The electronic circuit acquires an attribute value related to the dose of the medicine discharged from the reservoir by the discharge means during the discharge event, the sensor means, the processor means for determining the dose based on the obtained attribute value, and the log Storage means for storing a plurality of doses to create In such a system, the doses determined within a given period may be summed or summed into a single summed dose, wherein the given period is the previous detection Initiated by a sensed dispense event occurring after a given period of time has elapsed since the dispense event or after a given sensed operation.

  The system may be in the form of an integrated drug delivery device comprising a drug reservoir or drug reservoir containing means, a drug delivery means, and an electronic circuit. The integrated device may comprise the features of the separate logging device described above.

  Several techniques may be used to obtain attribute values related to the dose of drug to be delivered. For example, in an integrated configuration, acquisition may be based on galvanic contacts, optical sensors, or magnetic sensors. In fact, the same principle may be used for externally mountable logging devices, but using magnetic sensing to detect movement inside the delivery device without having to have openings or contacts in the wall of the housing Is possible. For a given dispensing mechanism, usually some parts move in response to the dose of medicament being dispensed, for example, the piston rod can move axially and the drive member that moves the piston rod can rotate . Correspondingly, the attribute value may be either an axial displacement or amount of rotation or a combination thereof. For example, if a given part rotates more than 360 degrees to dispense a given dose, count the increments or alternatively, determine the rotational position of the rotary part and axially The amount of rotation is obtained by summing with the information on the number of full rotations or the axial position of the moved part.

  The term processor means, as used in the context of the application of the invention and in the specification and in the claims, refers to a particular one (for example, processing and storage of data, and control of memory and all connected input / output devices). It includes any combination of electronic circuits suitable to provide functionality. The processor means may typically include one or more CPUs or microprocessors, which may be supplemented by additional devices for support, storage or control functions. For example, if a communication (eg, wireless) interface is equipped, the transmitters and receivers may be fully or partially incorporated into the processor or equipped with each unit. Each component forming the processor circuit may be a special purpose or general purpose device. The term display means encompasses any type of display, such as, for example, an LCD or an OLED, which can visually provide certain functions.

  As used herein, the term "insulin" refers to any drug-containing flowable drug (liquid, solution, gel or fine) that can pass through a delivery means such as a cannula or hollow needle in a controlled manner. Suspensions, etc.) are included, and these (eg, human insulin or their analogs and non-insulin such as GLP-1 and their analogs etc.) have the effect of controlling blood glucose levels. In the description of the exemplary embodiment, reference is made to the use of insulin.

  The invention will be further described below with reference to the drawings.

1 shows a pen-type drug delivery device with an electronic logging module. 1 shows a pen-type drug delivery device with an electronic logging module. Indicates the inside of the logging module. FIG. 5 is a flow diagram illustrating an exemplary use of a pen-type drug delivery device with logging means. 1 shows a pen-type drug delivery device with an integrated logging module. 1 shows a pen-type drug delivery device with an integrated logging module. 7 illustrates a logging module incorporated into a drug delivery device. 1 shows a drug delivery pen comprising a logging module and in communication with a smartphone.

  In the drawings, like structures are identified primarily by like reference numerals.

  Where words such as "upper" and "lower", "right" and "left", "horizontal" and "vertical" or similar relative representations are used hereinafter, these refer only to the accompanying drawings It does not necessarily indicate the actual use situation. The figures shown are schematic representations because the construction of the various structures and their relative dimensions are intended to serve only for illustrative purposes.

  1A and 1B show a pen-type drug delivery device with an electronic logging module attached. In the context of the present description, the device represents a "general" drug delivery device which provides a specific example of the device, in which embodiments of the invention are used in combination with such a device or such Various devices may form the basis of aspects of the present invention.

  More specifically, logging module 100 comprises a body portion 110 and a ring portion 120 that allows the module to be attached to a generally cylindrical pen device. The body portion comprises an electronic circuit, sensor means enabling an attribute representative of the amount of medicament dispensed from the cartridge to be detected, and a display 130 for displaying to a data user. The ring portion comprises connecting means which allow the module to be securely and accurately mounted on the pen body. The electronic circuit and the sensor means may be arranged partly in the ring part.

  The pen device 200 is drug-filled and distal with a main portion having a cap portion 207 and a drive assembly portion with a proximal body, ie a housing 201 in which the drug discharge mechanism is disposed or integrated. A distal cartridge holder portion in which a transparent cartridge 213 with a needle puncturable gap is disposed and held in place by a non-removable cartridge holder attached to the proximal portion, the cartridge holder comprising There is an opening through which a portion of the eye can be examined, as well as a distal connection means 215 which allows the needle assembly to be removably mounted. The cartridge comprises a piston forming part of the dispensing mechanism and driven by a piston rod, for example containing insulin, GLP-1 or a growth hormone preparation. The most recent dose rotatable dose member 280 functions to manually set (or dial) the desired drug dose shown in the display window 202 and then the dose is delivered when the button 290 is actuated. As in the illustrated embodiment, depending on the type of dispensing mechanism implemented in the medication dispensing device, the dispensing mechanism is a spring that distorts during dose setting and then releases when the release button is actuated to drive the piston rod. Can be provided. Alternatively, the dispensing mechanism may be completely manual, in which case the dose member and the actuation button move proximally according to the set dose size during dose setting and then discharge the set dose To be moved distally by the user.

  Figures 1A and 1 B show a drug delivery device of the prefilled type (i.e. supplied with a pre-loaded cartridge and discarded when the cartridge is empty). In an alternative embodiment, the drug delivery device is, for example, in the form of a "rear-loaded" drug delivery device in which the cartridge holder is removed from the main part of the device, to allow the loaded cartridge to be replaced. Designed or, alternatively, in the form of a "forward filling" device in which the cartridge is inserted through the distal opening of the cartridge holder, it is irremovably mounted to the main part of the device.

  Referring to FIG. 2, an exemplary embodiment of a logging module 300 is shown where the outer housing is removed to expose the internal design and components. The module comprises a main body 310 having a generally cylindrical ring portion 320 and a body portion 330 on which most of the electronic circuitry is mounted. The main body is made of LDS polymer, so that integrated wiring using LDS (Laser Direct Structuring) technology can be achieved, the polymer has elasticity and it is flexible hinged Allows the latch to be integrally molded. More specifically, the ring portion comprises a generally cylindrical inner surface attached to the drug delivery pen body, and a pair of opposing integrally formed connection structures 321 engaging with corresponding connection structures of the pen device; Make sure that the module is firmly attached. The distal portion of the ring portion has a larger diameter and includes a distally facing peripheral stop surface 329 that receives and engages the cap when the module is attached to the pen as shown in FIG. 1B.

  The inner ring surface and the outer pen body surface may either be conformal in shape or slightly frictionally engaged. Each coupling structure of the module is in the form of a latch 322 having a proximal portion 323, a distal portion 324, and a central portion, the latter being integrally molded allowing the latch to pivot several degrees corresponding to the circumferential axis It is pivotally connected to the ring portion by a flexible hinge 325. This configuration causes the distal latch portion to move inward as the proximal portion moves outward, and vice versa. The proximal latch portions are each capped with an inner protrusion 326 which engages with the corresponding connection structure of the pen device, as well as with the cap being inserted by the peripheral gap 214 (shown in FIG. 1B) between the logging module and the cartridge holder. A distal latch portion is provided, each comprising a projection 327 that engages the cap when attached to the body. In order to ensure accurate rotational mounting of the module on the pen, the module is provided with slots (not shown) which axially engage the corresponding pen projections. In the embodiment shown in FIG. 1A, the pen cartridge holder 210 is provided with a projection and is disposed opposite the pen display window 202, whereby the electronic display 130 is displayed on the pen when the module is attached to the pen. Placed next to Most of the electronic component 340, the display 341, the cap switch 342, and the battery 343 are attached to the main body 330. In the illustrated embodiment, the logging module comprises three sensors in the form of magnetometers 345 arranged at the periphery and directly attached to the ring portion 320, the majority of these sensors and electronic components being connected using LDS Ru. Magnetometers and electronic circuits are described, for example, in more detail in EP patent application 13162517.0, attribute values in the form of rotational movement of the magnetic means of the enclosed dispensing mechanism in relation to the dose of medicament dispensed. To detect and acquire. For example, additional sensors may be provided which allow to recognize the type of device. For example, the sensor may be provided adapted to sense the color of the part of the pen on which the logging module is mounted or to read a correspondingly arranged barcode.

  The logging module may for example be a user input means in the form of one or more buttons (not shown) allowing the user to control the module (eg allowing the user to toggle the log entry) It can be equipped. The logging module may further comprise transmission means enabling data to be transmitted from the module (e.g. log data may be transmitted to the user's smartphone by NFC or other wireless means).

  Referring to FIGS. 1-3, an example of using the above-described assembly to dispense an amount of insulin formulation will be described. First, the user removes the cap from the assembly so that the logging module is turned on using the cap switch 342. The display may display different messages (eg, last log entry, etc.). In the illustrated embodiment, the display is muted, for example after 5 seconds, and remains muted until the cap is in place, which indicates that the user has taken the desired dose. This procedure is also available if the user wants to check log entries for the last dose. If not in place, a needle assembly may be attached to the cartridge holder connection 215 and then a flow check may be performed by setting and dispensing a small dose (eg, 2 units (IU)) of insulin . Although the dispensed dose is detected by the logging module, in the illustrated embodiment the logging module recognizes small doses, for example 3 IU or less, as being associated with the flow check operation, so they are as log entries It is not memorized. After the flow check is performed, the user sets the desired dose (here 50 IU). Since this is a relatively large dose, the user splits and dispenses (and injects) the dose as three smaller doses of 15 IU, 15 IU, and 20 IU, for example, for 1 minute each as shown. Decide to do. Once the first dose has been dispensed, a time window (e.g., 5 minutes) for adding the doses is initiated, which adds the three doses in the log into a single dose of 50 IU. The time associated with the summed log may be, for example, the time of the last dose. When the user moves the cap back into place, the combined 50 IU dose is displayed in the log entry. If the dose was not summed, the last log entry would be 20 IU, which would mislead the user that the full dose of 50 IU was not taken, increasing the risk of unintended overdose.

  Referring to FIGS. 4 and 5, an embodiment of a drug delivery system in which the logging module is integrated into the pen drug delivery device will be described.

  More specifically, the pen device includes a cap portion (not shown), a proximal body or drive assembly portion 420 with a housing 120 and a distal portion with a drug delivery mechanism disposed and integrated therewith. A drug filled transparent cartridge 480 having a needle pierceable septum 132 comprises a main portion comprising a distal cartridge holder portion which can be positioned and held in place by a cartridge holder 410 attached to the proximal portion; The cartridge holder has an opening through which a portion of the cartridge can be inspected. The device is designed such that a new cartridge is loaded by the user through the distal receiving opening of the cartridge holder, the cartridge comprising a piston which is propelled by a piston rod forming part of the discharge mechanism. The most recent rotatable dose ring member 425 serves to manually set the desired drug dose shown in the display window 426 and then the dose is dispensed when the release button 427 is actuated. Depending on the type of dispensing mechanism implemented in the medication dispensing device, the dispensing mechanism may comprise a spring that distorts during dose setting and then releases when the release button is actuated to drive the piston rod. Alternatively, the dispensing mechanism may be completely manual, in which case the dose ring member and release button move proximally according to the set dose size during dose setting and then set the set dose It is moved distally by the user to eject. The cartridge comprises a distal coupling means 482 in the form of a needle hub mount, and in the example shown coupling means 133 has an external thread 485 adapted to engage the internal thread of the corresponding hub of the needle assembly. In an alternative embodiment, the screw may be combined with or replaced by other connection means (eg, bayonet connection).

  The cartridge holder comprises a distal opening for receiving the cartridge. More specifically, the cartridge holder controls the movement of the gripping means, whereby the outer rotatable tube is manipulated by the user to open and close the grip shoulder 445 configured to grip and hold the cartridge A member 470 is provided. Figure 5 shows the device in the "open" position with the cartridge removed and the grip shoulder unlocked, in which position the cartridge can be removed and a new one inserted.

  As shown, FIG. 4 shows a forward-loading type drug delivery device, in which the cartridge is inserted through the distal opening of the cartridge holder and non-removably attached to the main part of the device, but alternatively Alternatively, the drug delivery device may comprise a cartridge holder which is removed from the main part of the device, in which case the cartridge is received through the proximal opening and removed.

  Referring to FIG. 6, a subassembly 500 for a drug delivery device is described, wherein the subassembly is combined with a portion of the drug delivery device that is functionally directly related to the installation and operation of the logging unit. Equipped with More specifically, the subassembly includes an electronically controlled logging module 600, an inner tube member 510, a generally cylindrical inner housing member 520, a dial ring member 530, and a button ring 540, a button window 541, and a button spring 542. And a button assembly. The inner housing member is configured to be disposed inside the outer housing member and provides the outside of the drug delivery device.

  While the logging module of FIGS. 1 and 2 is based on non-contact detection of movement inside the pen device, the logging modules of FIGS. 4 to 6 are mechanical to the discharge mechanism in order to detect the rotational movement of the parts of the mechanism. Engage in In the illustrated embodiment, a rotary sensor is provided to detect rotation between the rotary member of the dispensing mechanism and the logging module, and the portion non-rotating within the housing except the portion connected to the rotary dispensing member of the sensor Placed in the formula. The illustrated logging module is described in more detail in EP patent application 13162517.0.

  In an exemplary embodiment, the rotary sensor is designed to count the number of steps during setup and to count down the number of steps during dispensing, the dispensing steps being logged as the dose is dispensed. be registered. Counting both directions ensures a high level of correct registration and functionality of the logging module. Because a given dose of drug may be split and injected with a given pause, especially for large doses, the logging module ejects within a given time window (eg, 5 minutes) Are programmed to log the two doses done as one dose.

  The logging module may be configured to store and show data in various manners. For many users, the time since the last dose and the size of the dose are the most important values. An overview of the log for a given period of time (eg, a week or a month) may be important to other users and / or healthcare workers. To enable such an overview, the logging module may, for example, transfer external display device (eg smartphone or computer) dose logs, such as by NFC transmission, for better image appearance. An output means may be provided to enable.

  To ensure that the full dose is delivered, the logging module may be set to display the last delivered dose only when the dispensing mechanism returns to zero. Otherwise, the given "half" dose is stored in the log but not displayed. For example, a dose of 40 IU is dialed and 20 IU is dispensed, immediately after which the display shows no data for this delivery. To have the dose displayed on the display, the user dispenses the remaining dose, and the summed 40 IU dose is shown on the display along with the timestamp. Alternatively, the user dials the dispensing mechanism back to zero and the display shows 20 IU or the user dials the dispensing mechanism back to 10 IU to dispense 10 IU and the display shows 30 IU. In fact, two (or more) doses must be dispensed within the above-mentioned time window (e.g. 5 minutes) in order for the dispensed amounts to be summed. Otherwise, only the last part of the dose is displayed and the first part is stored only as an entry in the log.

  The display may be configured to occupy data in various forms. For example, the display may have two lines, in which case the time is shown using a hour-hour-minute-second-second stopwatch format, which has elapsed since the last dose dispensed from the device A time may be indicated using a second counter in progress, which allows the user to easily identify the displayed information as a count of time values. After 24 hours, the display may continue to display the time in hour: minute: second second format, and may change to date and time format.

  The display may be turned off after a predetermined period of time (eg, 30 seconds) to conserve power. To turn on the display again, the user may, for example, press a button or the display may be turned on when the dose dial is dialed away from zero and then back to zero.

  The user may want to check the dose log directly on the module display. Toggling the dose log can also be controlled by the axial switch, for example, pressing the button 427 twice quickly causes the module to enter log display mode, and subsequently pressing the button causes the next log entry read out. The module may either leave the log display mode automatically after a given period of time, or the user may transition the module to the normal display mode, for example by dialing and dialing back as described above. Alternatively, the electronic module is for example shaken or tapped by the user, or incorporated in the display, as is well known, for example, with a smartphone that allows the user to turn on the display by swiping a finger on the display It may be equipped with other types of input means, such as a motion sensor, which allow to turn on the display by touching the sensor.

  FIG. 7 is a logging module of the type described above with reference to FIGS. 4 to 6 disposed next to a smartphone 430 configured to receive logging data from the logging module via wireless communication (eg, NFC) 7 shows a drug delivery pen 400 equipped with 500. As shown, the logging module comprises a display configured to indicate the size of the last dose and the time elapsed since the last administration using the stopwatch display mode.

  To communicate with the logging module, the smartphone is equipped with a unique "insulin diary" software. When the software is activated to initiate data transfer, the smartphone's NFC transmitter transmits a specific code to activate any neighboring logging module and then transmits a unique code identifying the specific module Do. When a specific code is received for the first time, the user is asked to approve the pairing and lists the given medication (eg "Mix30" as shown), to be associated with the given logging module You will be asked to choose from. In this manner, a smartphone can create an insulin diary that targets multiple medications. With the simple "manual" setting described, the user must ensure that the correct (e.g., containing Mix30 insulin) cartridge is loaded into the drug delivery pen associated with that type of drug. In fact, other settings may be intended, for example, (mechanically) encoded such that a given pen approves only a given type of cartridge containing a particular type of medication, or a pen And a logging module may be equipped with various types of cartridges and thereby the ability to identify the type of medication.

  In the illustrated embodiment, log data from the logging module associated with Mix 30 insulin is being transferred. In an exemplary user interface, the user can toggle and toggle back between various date views, each showing the amount of different medication delivered with the actual time value. In FIG. 7, on a given day 431, a first amount and a second amount of Mix 30 have been delivered indicating the time and amount for each delivery. It may be indicated whether a given dose is based on a combined dose.

  In the foregoing description of the exemplary embodiments, different structures and means for providing the described functionality for the different components have been described to the extent that the inventive concept is clear to the person skilled in the art. The detailed construction and specifications of the various components are considered as the subject of ordinary design processes practiced by those skilled in the art in accordance with the specification of the specification of the present invention.

Claims (15)

Releasably mounted on a drug delivery device comprising a drug reservoir (213) or drug reservoir containing means and a drug discharge means having a dose setting means (280) capable of setting the dose of the drug to be discharged on the user side Logging device (100, 300),
An electronic circuit (340) for producing a log of the dose of the dispensed drug,
Sensor means (345) for acquiring an attribute value related to a dose of the drug to be discharged from the reservoir by the discharge means during a discharge event when the logging device is attached to the drug delivery device;
A processor means for determining a dose based on the acquired attribute value;
An electronic circuit (340) comprising storage means for storing a plurality of doses to create said log;
The doses determined and stored within a given period can be summed or summed into a single summed dose,
The given period is
By detection of a discharge event occurring after a given period of time has elapsed from a previously detected preceding discharge event, or by detection of a discharge event occurring after a given detected operation
Logging device (100, 300) to be started.   The logging device according to claim 1, wherein two or more doses determined within a given time period are automatically summed.   The logging device of claim 1, wherein the user is interrogated for summing two or more doses determined within a given time period.   The logging according to any one of claims 1 to 3, wherein one of the determined doses below a given value is considered to be priming or blanking, not stored as a log entry or not summed up. apparatus.   5. A logging device according to any one of the preceding claims, wherein the log comprises time values attached to each stored dose.   6. A logging device according to any one of the preceding claims, further comprising a display (130, 711) controlled by the electronic circuit to display a dose.   The sensor means acquires an attribute value represented by the amount of rotation of the magnetic member disposed in the medicine delivery device, and the amount of rotation of the magnetic member corresponds to the amount of medicine discharged from the reservoir by the discharge means A logging device according to any one of the preceding claims.   8. A device according to any of the preceding claims, wherein the logging device is combined with a drug delivery device (200) comprising a drug reservoir (213) or drug reservoir containing means and drug delivery means. A logging device (100, 300) according to any one of the preceding claims, which is removably attachable to the drug delivery device.   The device further comprises a cap (207) removably mounted on the drug delivery device to cover the outlet portion of the drug reservoir, wherein the logging device detects that the cap has been mounted and the cap is in progress to allow for ongoing operation. The drug delivery system according to claim 8, wherein a period of time is ended, and a plurality of doses detected since the start of the period are summed. The drug delivery device further comprises an identifier representing information about a particular drug type or a particular drug delivery device contained in the reservoir;
The logging device further comprises means (340) for acquiring information from the identifier;
The drug delivery system according to claim 8 or 9, wherein the electronic circuit creates a log for a given identifier.   11. The drug delivery system according to claim 10, wherein the identifier is in color or in the form of a barcode. A drug delivery system,
A drug reservoir (213) or drug reservoir storage means;
Drug discharge means comprising a dose setting means (280) capable of setting a drug dose to be discharged on the user side;
An electronic circuit (340) for producing a log of the dose of the dispensed drug,
Sensor means (345) for acquiring an attribute value related to the dose of the medicine discharged from the reservoir by the discharge means during the discharge event;
An electronic circuit (340) comprising: processor means for determining a dose based on the acquired attribute value; and storage means for storing a plurality of doses to create the log.
The doses determined and stored within a given period can be summed or summed into a single summed dose,
The given period is
By detection of a discharge event occurring after a given period of time has elapsed from a previously detected preceding discharge event, or by detection of a discharge event occurring after a given detected operation
Initiated drug delivery system. Said drug reservoir or drug reservoir storage means;
The medicine ejection means;
13. A drug delivery system according to claim 12, in the form of a drug delivery device (400, 700) comprising the electronic circuitry.   The sensor means acquires an attribute value represented by the amount of rotation of the magnetic member disposed in the medicine delivery device, and the amount of rotation of the magnetic member corresponds to the amount of medicine discharged from the reservoir by the discharge means 14. A drug delivery system according to claim 12 or 13.   The drug delivery system according to claim 1, wherein two or more doses determined within a given time period are automatically summed.