JP6756806B2 - Logging device that combines multiple doses - Google Patents

Description

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

In the disclosure of the present invention, drug delivery devices with threaded piston rods driven by rotation drive members are most often referred to, although such devices are used, for example, in the treatment of diabetes by delivery of insulin. , This is only an exemplary use of the present invention.

Lethal injection devices have greatly improved the lives of patients who have to self-administer drugs and biologics. Lethal injection devices can take many forms and are durable, either from something like a simple disposable device that is nothing more than an ampoule with a means of injection, or in combination with a pre-filled cartridge. It can be a device. Regardless of form or type, lethal injection devices have been shown to be a great aid to patients in self-administering injectable drugs and biologics. Lethal injection devices also greatly assist caregivers in administering injectable drugs to people who are unable to perform self-injection.

Injecting the required insulin at the right time and in the right size is critical to managing diabetes, i.e., adherence to a particular insulin regimen. It is recommended that diabetics keep a diary (log) of the size and time of each injection so that medical personnel can determine the effectiveness of the prescribed dosing pattern. However, since such diaries are usually recorded in handwritten notes, the information contained cannot be easily uploaded to a computer for data processing. In addition, only the events that are noted by the patient are listed, so in order for the information provided to have some value in the treatment of the patient's illness, the patient must remember to list each injection. Is required on the notebook system. Forgotten or incorrect records can lead to misleading injection history and therefore misleading information that underlies medical professional decisions regarding future medications. Therefore, it is desirable to automate the entry of injection information from the drug delivery system.

Some injection devices integrate a monitoring / acquisition mechanism into the device itself, for example as disclosed in US 2009/0318865, but most devices today do not have it. The most widely used equipment is either durable or pre-filled, purely mechanical equipment. Since the latter device is inexpensive and is thrown away when it is empty, incorporating an electronic data acquisition function into the device itself is not worth the cost-effectiveness. Several solutions have been presented to address this issue and help users generate, collect, and distribute data indicating the use of a given medical device.

For example, WO2007 / 107564 discloses an electronic "add-on" module that is mounted on and thereby measures a standard mechanical pen-type device, which module operates, for example, from the device. It depends on the unique voice that is sometimes generated.

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

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

In the disclosure of the present invention, embodiments and aspects are described that address one or more of the above objectives, or address an object apparent from the disclosure below and the description of exemplary embodiments.

According to the first aspect of the present invention, a logging device that is detachably attached to the drug delivery device is provided, and the drug delivery device uses a drug reservoir or a drug reservoir storage means and a dose of the discharged drug. The logging device comprises an electronic circuit for creating a log of the dose of the dispensed drug, with a drug dispensing means having a dose setting means that allows the device to be set. The electronic circuit creates a sensor means that acquires an attribute value related to the dose of the drug discharged from the reservoir by the discharge means during a discharge event, a processor means that determines the dose based on the acquired attribute value, and a log. A storage means for storing multiple doses is provided. Each memory dose measured within a given period can be combined or summed into a single combined dose. It should be noted that the given period is started after a certain period of time has elapsed from the previously detected preceding discharge event or when the discharge event is detected after the detected given action.

When a plurality of doses are defined as stored, each dose will be stored, for example, as an attribute value of the dose obtained as it is or as a calculated value of the dose. The term "discharge event" refers to a first state in which the discharge means is operating (eg, by releasing a drive spring, operating an electric motor, or pressing a drive button) to initiate drug discharge, and then thereafter. It is the discharge of the drug generated before the first subsequent state in which the operation is stopped or stopped. The drug continues to be ejected 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, for example, if the dose is large or if the cartridge needs to be replaced, the dose may be divided by the user. If an electronic logging device is provided, the result is a log of two entries, even though the user considers this dose to be a single dose. The above configuration allows the creation of logs corresponding to what the user considers to be a single dose (ie, a single log entry for essentially a split dose, which is the sum of the "split doses"). Become. As will be appreciated, each of the individual "split doses" represents a discharge event.

If it is detected that there have been more than one dose within a given period, these doses will be automatically added up or will be added to the two or more doses detected within a given time period. On the other hand, the user may be asked whether or not the summing should be performed. If a dose below a given value (eg, 2 or 3 units of insulin) is detected, the dose is determined to be priming or blank and is not stored as a log entry or added up. Not subject to. Even when the total dose is calculated and stored, the individual doses may still be stored and may be recalled later as appropriate. Time values can be associated with each stored dose. For the combined dose, for example, the first time value may be used.

The logging device may include a display that is controlled by electronic circuits and displays stored data. For example, a log entry can be shown as a drug dose along with a time value. The time can be the actual time value or the time since a given dose was stored. The summed amount can be displayed as such. Additional or alternative, the electronic circuit may include, for example, a transmitter means that transmits data stored using NFC means to an external receiver.

In an exemplary embodiment, the sensor means acquires an attribute value in the form of a rotation amount of the magnetic means arranged in the drug delivery device, and the rotation amount of the magnetic means is the rotation amount of the drug discharged from the reservoir by the discharge means. Corresponds to the quantity.

The logging device described above may be provided in combination with a drug delivery device, thereby forming a drug delivery system, wherein the drug delivery device comprises a drug reservoir or drug reservoir accommodating means, as well as a drug ejection means. It is removable and attachable to the drug delivery device.

The system is removable from the drug delivery device and further includes a cap to cover the outlet portion of the drug reservoir, and the logging device detects that the cap is fitted, thereby fitting the cap. However, it stipulates that the doses detected since the end of the ongoing period and the start of the period are added up.

In an exemplary embodiment, the drug delivery device further comprises an identifier in the form of a color or barcode that represents, for example, information about a particular drug type or particular drug delivery device contained within the reservoir. The electronic circuit creates a log for a given identifier, further providing a means of retrieving information from the identifier.

According to a further aspect of the present invention, a drug reservoir or a drug reservoir accommodating means, a drug dispensing means provided with a dose setting means that allows the user to set the dose of the drug to be discharged, and a discharged drug. A drug delivery system is provided with an electronic circuit that creates a log of drug doses. The electronic circuit acquires an attribute value regarding the dose of the drug discharged from the reservoir by the discharge means during the discharge event, determines the dose based on the acquired attribute value, the processor means, and the log. Provide storage means to store multiple doses to create. In such a system, the doses determined within a given period are combined or combined into a single combined dose, where the given period is the previous detection. It is initiated by a detected discharge event that occurs after a given period of time from the discharged event or after a given detected action.

The system can be in the form of an integrated drug delivery device with drug reservoir or drug reservoir storage means, drug ejection means, and electronic circuitry. The integrated device may have the features of the separate logging device described above.

Several techniques can be used to obtain attribute values for the dose of the dispensed drug. For example, in an integrated configuration, the acquisition may be based on galvanic contact, optical sensors, or magnetic sensors. In fact, the same principle may be used for externally mountable logging devices, but by using magnetic detection, the motion inside the delivery device can be detected without the need to have openings or contacts in the walls of the housing. Is possible. For a given discharge mechanism, usually some parts move in response to the dose of drug discharged, for example, the piston rod may move axially and the drive member that moves the piston rod may rotate. .. Correspondingly, the attribute value can be either axial displacement or rotation, or a combination thereof. For example, if a given part rotates more than 360 degrees to eject a given dose, by counting the increments, or alternative, determining the rotational position of the rotary part and axially. The amount of rotation is obtained by adding up with information about the number of full rotations of the moved part or the axial position.

As used in the application and in the specifications and claims of the invention, the term processor means is specific (eg, data processing and storage, and control of memory and all connected I / O devices). Includes any combination of electronic circuits suitable for providing functionality. Processor means may typically include one or more CPUs or microprocessors, which can be complemented by additional devices for assistive, storage, or control functions. For example, if a communication (eg, wireless) interface is equipped, the transmitter and receiver may be fully or partially incorporated into the processor or each unit may be equipped. Each component forming a processor circuit can be a device for a specific purpose or a general purpose. The term display means includes any type of display, such as an LCD or OLED, that can visually provide a particular function.

As used herein, the term "insulin" refers to any drug-containing fluid drug (liquid, solution, gel or micro) that can pass through delivery means such as a cannula or hollow needle in a controlled manner. These include (eg, suspensions, etc.) and these (eg, human insulin or analogs thereof and non-insulins such as GLP-1 and analogs thereof) have the effect of controlling blood glucose levels. In the description of exemplary embodiments, the use of insulin is referred to.

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

A pen-type drug delivery device equipped with an electronic logging module is shown. A pen-type drug delivery device equipped with an electronic logging module is shown. Shows 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. Shown shows a pen-type drug delivery device with an integrated logging module. Shown shows a pen-type drug delivery device with an integrated logging module. The logging module incorporated in the drug delivery device is shown. Indicates a drug delivery pen that has a logging module and communicates with a smartphone.

In the drawings, similar structures are identified primarily by similar reference numbers.

When words such as "upper" and "lower", "right" and "left", "horizontal" and "vertical", or similar relative expressions are used below, these refer only to the accompanying drawings. It does not necessarily refer to the actual usage situation. The drawings shown are schematic representations because the various structural configurations and their relative dimensions are intended to serve only exemplary purposes.

1A and 1B show a pen-type drug delivery device equipped with an electronic logging module. In the context of the present specification, the device represents a "general" drug delivery device that provides specific examples of the device, and embodiments of the invention are used in combination with such devices, or as such. Devices can form the basis of aspects of the invention.

More specifically, the logging module 100 includes a body 110 and a ring portion 120 that allows the module to be attached to a generally cylindrical pen device. The main body includes an electronic circuit, sensor means that enables detection of an attribute representing the amount of drug discharged from the cartridge, and a display 130 for displaying to a data user. The ring portion provides connecting means that allow the module to be securely and accurately mounted on the pen body. The electronic circuit and sensor means may be partially located in the ring portion.

The pen device 200 has a cap portion 207, a proximal body, a main portion having a drive assembly portion with a housing 201 in which a drug ejection mechanism is arranged or integrated, and a drug-filled and distal portion. A transparent cartridge 213 with a needle puncture gap is placed and comprises a distal cartridge holder portion held in place by a non-removable cartridge holder attached to the proximal portion, the cartridge holder being a cartridge. It has an opening through which a portion of the needle can be inspected, as well as a distal connecting means 215 that allows the needle assembly to be detachably mounted. The cartridge comprises a piston that forms part of a discharge mechanism and is driven by a piston rod and contains, for example, insulin, GLP-1 or growth hormone preparations. The near-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 ejected when the button 290 is activated. As shown in the illustrated embodiment, depending on the type of discharge mechanism implemented in the drug discharge device, the discharge mechanism is distorted during dose setting and then released when the release button is activated to drive the piston rod. Can be equipped. Alternatively, the discharge mechanism can be completely manual, in which case the dose member and 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.

1A and 1B show a prefilled type drug delivery device (ie, supplied with a pre-loaded cartridge, which is discarded when empty). In an alternative embodiment, the drug delivery device is, for example, a form of a "backloading" drug delivery device in which the cartridge holder is removed from the main part of the device, allowing the loaded cartridge to be replaced. Designed or, as an alternative, the cartridge is in the form of a "front filling" device that is inserted through the distal opening of the cartridge holder and is non-removably mounted on the main part of the device.

With reference to FIG. 2, an exemplary embodiment of the logging module 300 is shown, where the external housing is removed so that the internal design and components are exposed. 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 circuits are mounted. The main body is made of LDS polymer, which allows integrated wiring using LDS (laser direct structuring) technology, which is elastic and thereby 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 opposed integrally molded coupling structures 321 that engage the corresponding coupling structure of the pen device. Ensure that the module is securely attached. The distal portion of the ring portion has a larger diameter and comprises a distally oriented peripheral stop surface 329 that accepts 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 can either be shape-matched or slightly frictionally engaged. Each connecting 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 so that the latch can be pivoted several times corresponding to the circumferential axis. It is pivotally connected to the ring portion by a flexible hinge 325. With this configuration, when the proximal portion moves outward, the distal latch portion moves inward, and vice versa. The proximal latch portion is capped by insertion into the medial protrusion 326, which engages the corresponding coupling structure of the pen device, and the peripheral gap 214 (shown in FIG. 1B) between the logging module and the cartridge holder, respectively. Each comprises a distal latch portion, each comprising a protrusion 327 that engages the cap when attached to the body. To ensure that the module is accurately rotated and mounted on the pen, the module is provided with a slot (not shown) that axially engages the corresponding pen protrusion. In the embodiment shown in FIG. 1A, the pen cartridge holder 210 is equipped with a protrusion and is located on the opposite side of the pen display window 202 so that the electronic display 130 has a pen display window when the module is attached to the pen. Placed next to. Most of the electronic components 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 a magnetometer 345 located on the periphery and attached directly to the ring portion 320, the majority of these sensors and electronic components being connected using an LDS. Ru. Magnetometers and electronic circuits are attribute values in the form of rotational movement of the magnetic means of a sealed discharge mechanism, which are related to the dose of the discharged agent, as described in more detail, for example, in EP Patent Application No. 13162517.0. Is detected and acquired. For example, it may be equipped with additional sensors that allow it to recognize the type of device. For example, the sensor may be adapted and provided to detect the color of the portion of the pen to which the logging module is mounted, or to read the correspondingly placed barcode.

A logging module provides user input means in the form of one or more buttons (not shown) that allow the user to control the module, for example (eg, allow the user to toggle log entries). Can be prepared. The logging module may further include transmitting means that allow data to be transmitted from the module (eg, log data may be transmitted to the user's smartphone by NFC or other wireless means).

An example of using the above assembly to dispense a certain amount of insulin formulation will be described with reference to FIGS. 1-3. First, the user removes the cap from the assembly, which turns on the logging module using the cap switch 342. The display may display different messages (eg, the last log entry). In the illustrated embodiment, the display is muted, for example, after 5 seconds and remains muted until the cap is in place, indicating that the user has ingested the desired dose. This procedure is also available if the user wants to check the log entry for the last dose. If not in place, a flow check can be performed by attaching the needle assembly to the cartridge holder connector 215 and then setting and discharging a small dose (eg, 2 units (IU)) of insulin. .. The discharged doses are detected by the logging module, but in the illustrated embodiment, the logging module recognizes low doses, eg, 3 IU or less, as associated with the flow check operation, so they are as log entries. Not remembered. After the flow check is performed, the user sets the desired dose (here 50 IU). Since this is a relatively large dose, the user will dispense (and inject) the dose in divided doses, eg, over a minute, as three smaller doses, 15 IU, 15 IU, and 20 IU, respectively, as shown. Decide to do. When the first dose is dispensed, a time window (eg, 5 minutes) for summing the doses is initiated, which sums the three doses in the log into a single dose of 50 IU. The time associated with the combined log can be, for example, the time of the last dose. When the user puts the cap back in place, the combined dose of 50 IU is displayed in the log entry. If the doses were not combined, the final log entry would be 20 IU, which would allow the user to misunderstand that the full dose of 50 IU was not taken, increasing the risk of unintentional overdose.

An embodiment of a drug delivery system in which a logging module is integrated into a pen-type drug delivery device will be described with reference to FIGS. 4 and 5.

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, in which a drug ejection mechanism is located and integrated. A drug-filled transparent cartridge 480 with a needle punctureable diaphragm 132 comprises a main portion with a distal cartridge holder portion that can be positioned and held by a cartridge holder 410 attached to the proximal portion. The cartridge holder has an opening through which the portion of the cartridge can be inspected. The device is designed for the new cartridge to be loaded by the user through the distal receiving opening of the cartridge holder, the cartridge comprising a piston propelled by a piston rod forming a portion of the ejection mechanism. The near-rotatable dose ring member 425 acts to manually set the desired drug dose shown in the display window 426, and then the dose is ejected when the release button 427 is driven. Depending on the type of discharge mechanism implemented in the drug discharge device, the discharge mechanism may include a spring that is distorted during dose setting and then released when the release button is activated to drive the piston rod. Alternatively, the discharge mechanism can 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 the set dose. Moved distally by the user for ejection. The cartridge comprises a distal coupling means 482 in the form of a needle hub mount, in the illustrated example coupling means 133 having a male screw 485 adapted to engage the female screw of the corresponding hub of the needle assembly. In an alternative embodiment, the screw can be combined with or replaced by other connecting means (eg, bayonet connecting).

The cartridge holder comprises a distal opening for receiving the cartridge. More specifically, the cartridge holder controls the movement of the grip means, thereby operating the outer rotatable tube to open and close the grip shoulder portion 445 configured to grip and hold the cartridge. A member 470 is provided. FIG. 5 shows a device in the "open" position where the cartridge has been removed and the grip shoulder is unlocked, at which point the cartridge can be removed and a new one can be inserted.

As shown, FIG. 4 shows an anterior filling type drug delivery device, in which the cartridge is inserted through the distal opening of the cartridge holder and non-removably mounted on the main part of the device, but as an alternative. In addition, the drug delivery device may include a cartridge holder that is removed from the main part of the device, in which case the cartridge is received and removed through the proximal opening.

A subassembly 500 for a drug delivery device is described with reference to FIG. 6, a logging module in which the subassembly is combined with a portion of the drug delivery device that is functionally directly related to the incorporation and operation of the logging unit. To be equipped. More specifically, the subassemblies include 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. A button assembly is provided. The inner housing member is configured to be located inside the outer housing member and provides the outside of the drug delivery device.

Whereas the logging modules of FIGS. 1 and 2 are based on non-contact detection of movement inside the pen device, the logging modules of FIGS. 4-6 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 discharge mechanism and the logging module, and is non-rotating within the housing except for the portion connected to the rotary discharge member of the sensor. Placed in the formula. The illustrated logging module is described in detail in EP Patent Application No. 13162517.0.

In an exemplary embodiment, the rotary sensor is designed to count the number of steps during setup and count down the number of steps during ejection, and the ejection step logs as the dose is ejected. be registered. Counting in both directions ensures a high level of accurate registration and functionality of the logging module. The logging module is dispensed within a given time window (eg, 5 minutes) because a given dose of the drug may be divided and injected with a given pause, especially for large doses. The two doses given are programmed to be logged as one dose.

The logging module can be configured to store and present data in various ways. For many users, the time since the last dose and the size of the dose are the most important values. For other users and / or healthcare professionals, an overview of logs for a given period of time (eg, a week or a month) can be important. To enable such an overview, the logging module allows the dose log of an external display device (eg, a smartphone or computer) to be transferred, for example by NFC transmission for a better image overview. It may be equipped with an output means that enables it.

To ensure that the entire dose is dispensed, the logging module may be configured to display the last dose dispensed only when the discharge mechanism returns to zero. Otherwise, the given "half" dose will be logged but not displayed. For example, a dose of 40 IU is dialed and 20 IU is ejected, immediately after which the display does not show data for this delivery. To have the dose shown on the display, the user dispenses the remaining dose and the combined dose of 40 IU is shown on the display with a time stamp. Alternatively, the user dials the discharge mechanism back to zero and the display shows 20 IU, or the user dials the discharge mechanism back to 10 IU to discharge 10 IU and the display shows 30 IU. In fact, two (or more) doses must be dispensed within the time window (eg, 5 minutes) described above for the dispensed volumes to be summed up. Otherwise, only the last part of the dose will be displayed and the first part will only be remembered as an entry in the log.

The display can be configured to occupy data in various formats. For example, the display may have two lines, in which the time is shown using a stopwatch format of hours: minutes: minutes: seconds, which has passed since the last dose discharged from the device. Time can 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: hour: minute: second format, or may change it to date and time format.

To save power, the display can be turned off after a predetermined period of time (eg, 30 seconds). To turn the display back on, the user can turn the display on, for example by pressing a button or dialing the dose dial 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 an axial switch, for example, pressing button 427 twice quickly will cause the module to enter log display mode, followed by pressing the button for the next log entry. read out. The module may automatically leave log display mode after a given period of time, or the user may shift the module to normal display mode, for example by dialing and dialing back as described above. As an alternative, electronic modules have been shaken or tapped by the user, or built into the display, as is well known in smartphones, for example, where the user can turn on the display by swiping a finger on the display. It can be equipped with other types of input means, such as motion sensors, that allow the display to be turned on by touching the sensor.

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

To communicate with the logging module, smartphones are equipped with unique "insulin diary" software. When the software is activated to initiate a data transfer, the smartphone's NFC transmitter transmits a specific code that activates any nearby logging module, and then a unique code that identifies the specific module. To do. When a particular code is received for the first time, the user is asked to approve the pairing and lists a given drug (eg, "Mix30" as shown) to be associated with a given logging module. You will be asked to choose from. In this way, smartphones can create insulin diaries for multiple drugs. With the simple "manual" settings described, the user must ensure that the correct cartridge (including, for example, Mix30 insulin) is loaded into the drug delivery pen associated with that type of drug. In fact, other settings may be intended, for example, a given pen may be (mechanically) encoded to approve only a given type of cartridge containing a particular type of drug, or the pen. And the logging module may be equipped with the ability to identify different types of cartridges and thereby drug types.

In the illustrated embodiment, log data from the logging module associated with Mix30 insulin is being transferred. In an exemplary user interface, the user can toggle and toggle back between different dated views, each dated view showing the different doses delivered along with actual time values. In FIG. 7, on a given day 431, a first amount and a second amount of Mix30 are served, showing the time and amount for each delivery. It may be indicated whether a given dose is based on the combined dose.

In the above description of the exemplary embodiments, different structures and means that provide the functions described for different components have been described to some extent by those skilled in the art with the concepts of the present invention. Detailed construction and specifications in the various components are considered subject to normal design processes performed by those skilled in the art in accordance with the provisions of the specifications of the present invention.

Claims (15)

Removed to a drug delivery device including a drug reservoir (213) or drug reservoir storage means in the form of a cartridge and a drug discharge means having a dose setting means (280) in which the dose of the discharged drug can be set by the user. A logging device (100, 300) that can be mounted.
An electronic circuit (340) that creates a log of the dose of the discharged drug.
If the logging device is mounted on the drug delivery device, and acquires the attribute values relating to the dose of drug out ejection from the cartridge by the medicine ejection unit during the discharge event, a sensor means (345),
A processor means that determines the dose based on the acquired attribute values,
An electronic circuit (340) comprising a storage means for storing a plurality of doses to create the log.
Within a given period, multiple doses determined and stored as divided doses can be combined or can be combined into a single combined dose.
The given period
By detecting a discharge event that occurs after a given period of time has passed since a previously detected preceding discharge event, or by detecting a discharge event that occurs after a predetermined detected action.
Started ,
The single combined dose includes the sum of a plurality of doses discharged without replacement of the cartridge.
Logging device (100, 300). The logging device according to claim 1, wherein two or more doses determined within a given period are automatically added together. The logging device of claim 1, wherein the logging device asks the user to add up two or more doses determined within a given period of time. The determined dose according to any one of claims 1 to 3, which is considered to be priming or blank and is not stored or added up as a logging item. Logging device. The logging device according to any one of claims 1 to 4, wherein the log includes a time value attached to each stored dose. The logging device according to any one of claims 1 to 5, further comprising a display (130, 711) that is 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 arranged in the drug delivery device, and the amount of rotation of the magnetic member corresponds to the amount of drug discharged from the reservoir by the discharge means. The logging device according to any one of claims 1 to 6. Any of claims 1 to 7, wherein the logging device is combined with the drug reservoir (213) or the drug reservoir storage means and the drug delivery device (200) provided with the drug discharge means to form a drug delivery system. The logging device (100, 300) according to the above item, which is removable and attachable to the drug delivery device. A cap (207) that is detachably attached to the drug delivery device and covers the outlet portion of the drug reservoir is further provided, and the logging device detects that the cap has been attached and is in progress by attaching the cap. The drug delivery system according to claim 8, wherein a plurality of doses detected since the end of the period and the start of the period are added up. The drug delivery device further comprises an identifier representing information about a particular drug type or 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. 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 a drug reservoir storage means in the form of a cartridge ,
A drug discharging means provided with a dose setting means (280) capable of setting the discharged drug dose on the user side, and
An electronic circuit (340) that creates a log of the dose of the discharged drug.
Sensor means for acquiring attribute values relating to the dose of drug to be issued ejection from the cartridge during ejection event by the medicine ejection unit (345),
An electronic circuit (340) comprising a processor means for determining a dose based on an acquired attribute value and a storage means for storing a plurality of doses for creating the log.
Within a given period, multiple doses determined and stored as divided doses can be combined or can be combined into a single combined dose.
The given period
By detecting a discharge event that occurs after a given period of time has passed since a previously detected preceding discharge event, or by detecting a discharge event that occurs after a predetermined detected action.
Started ,
The single combined dose includes the sum of a plurality of doses discharged without replacement of the cartridge.
Drug delivery system. With the drug reservoir or drug reservoir storage means
With the drug discharging means
The drug delivery system according to claim 12, which is in the form of a drug delivery device (400, 700) including the electronic circuit. The sensor means acquires an attribute value represented by the amount of rotation of the magnetic member arranged in the drug delivery device, and the amount of rotation of the magnetic member corresponds to the amount of drug discharged from the reservoir by the discharge means. The drug delivery system according to claim 12 or 13. The drug delivery system of claim 8 , wherein the two or more doses determined within a given period are automatically added together.