WO2018028886A1 - Dispositif de génération de données de protocole pour un stylo injecteur - Google Patents

Dispositif de génération de données de protocole pour un stylo injecteur Download PDF

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Publication number
WO2018028886A1
WO2018028886A1 PCT/EP2017/066652 EP2017066652W WO2018028886A1 WO 2018028886 A1 WO2018028886 A1 WO 2018028886A1 EP 2017066652 W EP2017066652 W EP 2017066652W WO 2018028886 A1 WO2018028886 A1 WO 2018028886A1
Authority
WO
WIPO (PCT)
Prior art keywords
injection pen
protocol data
medicament
delivery
signal processing
Prior art date
Application number
PCT/EP2017/066652
Other languages
English (en)
Inventor
Marcus Vetter
Matthias Koehler
Uwe Kraemer
Timm Wiedemann
Original Assignee
Roche Diabetes Care Gmbh
F. Hoffmann-La Roche Ag
Roche Diabetes Care, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Roche Diabetes Care Gmbh, F. Hoffmann-La Roche Ag, Roche Diabetes Care, Inc. filed Critical Roche Diabetes Care Gmbh
Publication of WO2018028886A1 publication Critical patent/WO2018028886A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/31568—Means keeping track of the total dose administered, e.g. since the cartridge was inserted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/332—Force measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3365—Rotational speed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3375—Acoustical, e.g. ultrasonic, measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3584—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or bluetooth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6009—General characteristics of the apparatus with identification means for matching patient with his treatment, e.g. to improve transfusion security
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated

Definitions

  • the present invention relates to a device for generating protocol data for an injection pen. Moreover, the invention relates to an injection pen comprising the device for generating protocol data for an injection pen.
  • Medicaments such as insulin are delivered in doses that normal- ly correspond to individual characteristics of a patient, such as body mass, age, blood sugar level, gender, etc, and to the current behaviour of the patient, such as the intention to have a meal.
  • Injection pens include an injection needle for delivery of the medicament from a reservoir of the injection pen into the patient. Injection pens further include a dosing mechanism for adjusting a dosage of the medicament and an activation mechanism for delivery of the adjusted dosage of the medicament into the patient.
  • injection pens are purely mechanical devices.
  • An injection pen usually accommodates multiple dosages of the medicament so that a patient can use the same injection pen multiple times.
  • the reservoir of the injection pen can be replaced.
  • Delivering an individualized dosage of a medicament using an injection pen includes performing a sequence of several steps with the injection pen, such as, for example, the following steps.
  • the patient adjusts the dosage of the medicament to be delivered by manipulating a dosing mechanism of the injection pen, such as by rotating by an appropriate angle a dosing adjustment wheel of the injection pen.
  • the patient inserts the injection needle into the body by penetrating the skin with the injection needle.
  • the patient After having inserted the injection needle into the body, in a third step, the patient initiates the delivery of the adjusted dosage of the medicament by manipulating the activation mechanism, such as by pressing a delivery push-button of the injection pen. After having initiated the delivery of the dosage of the medicament, in a fourth step, the patient waits for a while in order to avoid leak out of the medicament. After having waited for a while, in fifth step, the patient retracts the injection pen. After having retracted the injection pen, in a sixth step, the patient replaces the injection needle. After having replaced the injection needle, in a seventh step, the patient puts away the injection pen.
  • the activation mechanism such as by pressing a delivery push-button of the injection pen.
  • Protocol data typically includes the dosage of the injection and the time of the injection. On the basis of protocol data, time and/or dosage of future injections can be determined. Protocol data is kept in a diary. Often, protocol data is manually recorded in a diary book or manually entered into a diary of a portable electronic device, such as a smartphone, a personal medical assistant, etc.
  • the portable electronic device can be configured to analyse the protocol data and to inform the patient about the time and/or dosage of future injections, for example about the need of a further injection after the lapse of a time period or in case the patient is approaching the time of day when the pa- tient usually eats a meal.
  • the portable electronic device can be configured to inform the patient about the need of a further injection by generating an alarm, such as an optical alarm, an acoustical alarm, a vibration etc.
  • the portable electronic device may generate an alarm signalling that an injection is required when the patient is in a business meeting, in a traffic jam, or otherwise averted.
  • the patient usually delays the injection.
  • the patient may forget to update correctly the time of the injection.
  • it may happen that the patient injects an incorrect dosage of the medicament for example because the patient incorrectly adjusts the dosage or because the patient retracts the injection pen too early. In such situations, it may happen that the patient is not even aware that the protocol data needs to be adjusted.
  • WO201 0/ 1 1 2575 relates to an arrangement for administering insulin or other medicines from a cartridge.
  • a dosing knob enables setting and administering of a dose.
  • the arrangement includes means for determining a set dose.
  • the means for determining a set dose can include electrical contacts or magnetic elements which produce on the basis of a relative interaction of corresponding electrical contacts or magnetic elements an electrical signal in accordance to the rotation of the dosing knob.
  • Data reflecting a set dose can be transmitted to a central data processing system.
  • US201 6/0030683 discloses smart sensors that can be coupled to or retrofitted onto injection pen injectors. The smart sensors improve tracking of drug self-administration and stop medication errors that occur primarily through self or automated injection, e.g.
  • the smart sensor can be in-line with respect to a drug delivery system's path of delivery.
  • the pen can have a needle adapter that includes the smart sensor.
  • Quick- connect interlocking means allow for coupling and decoupling of the components.
  • the smart sensor is capable of wirelessly communicating with a portable user interface.
  • the sensor can be a fluid detection sensor being in contact with the fluid.
  • the sensor can use impedance spectroscopy.
  • Other sensing techniques can include optical, electrical, me- chanical, thermal and/or rheological techniques.
  • EP2427236A2 discloses a medication injection supervisor device comprising a sensor to detect an injection automatically.
  • the sensor includes a micro switch or a micro optics subsystem.
  • Usage data is detected.
  • Usage data includes time of injection. Dosage of an injection is recorded.
  • a display is included to display injection data.
  • WO201 2001 493A2 discloses a replaceable cap for a transdermal liquid dosing device such as an insulin pen.
  • the cap includes an elongate hollow body with a first open end which can be placed over a front part of the dosing device and a second closed end opposite the first end.
  • the cap body also includes a cavity which opens into the interior of the cap body and which houses a control unit which includes a timer unit, a switch mechanism that stands at least partially proud of the cavity so as to project into the interior of the body, and a timer display unit which displays time counted by the timer unit on an outer surface of the body of the cap.
  • a control unit which includes a timer unit, a switch mechanism that stands at least partially proud of the cavity so as to project into the interior of the body, and a timer display unit which displays time counted by the timer unit on an outer surface of the body of the cap.
  • the switch mechanism is engaged by abutment of a surface of the front part of the dosing device when the cap is placed on the dosing device, and released when the cap is removed from the dosing device, the engagement and/or releasing of the switch mechanism causing the timer unit to reset after the elapse of a predetermined period of time, the time since the timer unit was last reset thereby indicating the time that has elapsed since the dosing device was last used.
  • the device comprises a motion sensing unit including a gyroscope and/or an accelerometer.
  • the device comprises a signal processing unit which is con- figured to analyse one or more signals of the motion sensing unit in order to generate protocol data reflecting an adjusted dosage of a medicament and delivery of the adjusted dosage of the medicament.
  • the gyroscope and/or the accelerometer can be implemented in the form of one or more MEMS devices (MEMS: micromechanical systems).
  • the signal processing unit can comprise one or more microprocessors running a signal processing application for the analysis of the signals of the gyroscope and/or the accelerometer.
  • the one or more microprocessors can further run a data generation application for the generation of protocol data based on the analysed signals of the gyroscope and/or the accelerometer.
  • the motion sensing unit can be coupled to the signal processing unit via a communication interface such as an I2C serial interface (I2C: Inter-Integrated Circuit), SPI interface (SPI: Serial Peripheral Interface), etc.
  • the device can be arranged with respect to the injection pen in a manner such that the motion sensing unit can register motions relating to a patient manipulating dosing adjustment means of the injection pen and/or delivery means of the injection pen, in order to enable the signal processing unit to analyse respective signals of the motion sensing unit.
  • the device further comprises a communication interface for transmitting generated protocol data to an external protocol data recording device.
  • the communication interface can be coupled to the signal processing unit.
  • the communication interface can include a wireless interface, such as an IR interface (IR: Infrared), a Bluetooth interface, a Bluetooth Low Energy interface, or a NFC interface (NFC: Near Field Communication).
  • the communication interface can include a wired interface, such as an USB interface (USB: Universal Serial Bus).
  • the external protocol data recording device can be configured to include a time stamp into protocol data upon receipt. Accordingly, protocol data does not only include the adjusted dosage of the medicament and delivery of the adjusted dosage, but also the time of delivery.
  • the external protocol data recording de- vice can be a smartphone, a CGM device (CGM: Continous Glucose Monitoring), a notebook computer, a desktop computer, etc.
  • the signal processing unit is configured to generate protocol data having included a time stamp. Accordingly, the protocol data does not only include the adjusted dosage of the medicament and delivery of the adjusted dosage, but also the time of delivery.
  • a time stamp as described herein can refer to a relative ticker or count.
  • the time stamp can refer to an absolute time (real time clock) such as the UTC time (UTC: Coordinated Universal Time), a time zone, etc.
  • the protocol data can include the adjusted dosage and the time of delivery of the medicament.
  • the time of delivery can be included into the protocol data either by the device itself, or by the external protocol data recording device receiving protocol data from the device.
  • the device further comprises a mounting arrangement configured to detachably mount the device to the injection pen.
  • the mounting arrangement can provide that the device can be mounted to the injection pen at a suitable location of the injection pen.
  • the mounting arrangement can provide that the device can be mounted to commercially available injection pens having included means for adjusting dosage and delivery of a medicament.
  • the device can have the form of a cap having included a mounting arrangement which is configured to mount the device to dosage adjusting means of the injection pen and/or to a delivery means of the injection pen.
  • the device can be adapted to provide an interface between a patient and the means arranged at the injection pen for manipulating the injection pen.
  • the device further comprises a user interface having a user output device and/or a user input device.
  • the user interface can be coupled to the signal processing unit.
  • the user output device can include a display, a loudspeaker, one or more LEDs (LED: light-emitting diode), a vibrating alert device, etc.
  • the user input device can include a touchscreen, one or more switches, a microphone, etc.
  • the signal processing unit can be configured to analyse one or more signals of the gyroscope and/or the accel- erometer in order to determine user input, for example to determine a user gesture.
  • the device is configured to generate protocol data on the basis of an angular velocity and /or a derivative of the angular velocity of a dosing adjusting means of the injection pen.
  • the motion sensing unit can be configured to generate one or more signals in accordance to an angular motion of a dosing adjusting means of the injection pen.
  • the signal processing unit can be configured to analyse one or more signals of the motion sensing unit by determining an angular velocity and/or a derivative of the angular velocity of the dosing adjusting means of the injection pen.
  • the device can be mounted to the dosing adjusting means of an insulin pen.
  • the dosing adjusting means can comprise a selector dial comprising a snap locking mechanism, wherein the speed of rotation and/or the acceleration of rotation of the selector dial can be used for the generating a characteristic signal.
  • the signal processing unit can be configured to perform a pattern matching and/or a pattern recognition in order to determine the adjusted dosage.
  • the signal processing unit can be configured to analyse the characteristic signal and to determine the number of dialled units and the direction of rotation.
  • the signal processing unit can be configured to sum up the number of dialled units and to take into account the direction of rotation in order to determine the adjusted dosage of the medicament.
  • the snap locking mechanism of the injection pen can be configured to produce clicks that are acoustically perceivable by the user of the injection pen.
  • the perceived clicks can correspond to the dialled units.
  • the signal processing units can be configured to analyse the characteristic signal in order to detect these clicks and to count the number of clicks in order to determine the adjusted dosage of the medicament.
  • the direction of rotation can be taken into account in order to determine the adjusted dosage of the medicament from the detected clicks.
  • the clicks can form the only basis for determining the adjusted dosage.
  • the device is configured to generate protocol data on the basis of one or more of an acceleration and a derivative of the acceleration of a delivery means of the injection pen.
  • the motion sensing unit can be configured to generate one or more signals in accordance to a linear motion of a delivery means of the injection pen.
  • the signal processing unit can be configured to analyse one or more signals of the motion sensing unit by determining an linear velocity and/or a derivative of the linear velocity of the delivery means of the injection pen.
  • the device can be mounted to the delivery means of the injection pen.
  • the delivery means can comprise a push-button for activating delivery of the medicament, wherein the push speed and/or the acceleration of the push speed can be used for generating a characteristic signal. Based on the characteristic signal, a pattern matching and/or a pattern recognition can be performed in order to determine the deliv- ery of the medicament.
  • the device comprising the motion sensing unit can be mounted to the dosing adjusting means and/or to the delivery means of an insulin pen.
  • mount the device comprising the motion sensing unit to a housing of the insulin pen, for example in the form of a bracket.
  • the quality of the signal generated by the motion sensing unit may be better than when the device is mounted to the housing of the insulin pen, because of the absorption or damping effect of the housing.
  • the signal processing unit is configured to determine orientation of the insulin pen and to generate protocol data distinguishing priming of the injection pen from delivery of the medicament.
  • One or more signals of the gyroscope and/or the accel- erometer can indicate that a patient holds the injection pen in an upright position indicating that the patient performs a priming.
  • One or more signals of the gyroscope and/or the accelerometer can indicate that a patient holds the injection pen in a downward position indicating that the patient performs a delivery of the medicament.
  • the needle of the injection pen In the upright position, the needle of the injection pen is at the top. In the downward position, the needle of the injection pen is at the bottom.
  • the injection pen In the upright position and the downward position, the injection pen can be aligned to a vertical reference line within an angle of about 0° to 30°, for example.
  • the signal processing unit is configured to generate protocol data in accordance to the determination of the orientation of the injection pen during delivery of the medicament, of the velocity of the delivery of the medicament, and/or of the time period between delivery of the medicament and retraction of the injection pen. If orientation of the injection pen indicates that the injection pen is held in a position adapted for delivery of the medicament, protocol data can include data reflecting that the injection is held in a position adapted for delivery of the medicament. If velocity of the delivery of the medicament indicates that delivery of the medicament is performed sufficiently slow, protocol data can include data reflecting that delivery of the medicament is performed sufficiently slow, indicating that the medicament has been delivered properly.
  • protocol data can include data reflecting that delivery of the medicament is performed too fast, indicating that the medicament has not been properly delivered. If the time period between delivery of the medicament and retraction of the injection pen is sufficiently long, protocol data can include data indicating that the time period between delivery and retraction is sufficiently long, indicating that the medicament has been delivered properly. If the time period between delivery of the medicament and retraction of the injection pen is too short, protocol data can include data reflecting that the time peri- od between delivery and retraction is too short, indicating that the medicament has not been properly delivered.
  • the signal processing unit is configured to determine a switch motion sequence and to switch the device from a low energy mode into a high energy mode upon detection of the switch motion sequence.
  • a wake-up function is provided.
  • the switch motion sequence can include a shaking of the injection pen, a sequence of particular positions of the injection pen with respect to ground, etc.
  • the signal processing unit is configured to determine one or more predefined motion sequences and to include one or more predefined data elements into the generated protocol data upon detection of the one or more predefined motion se- quences. For example, a motion for a downward position into a upward position and a shaking in the upward position can define that the patient realizes that a portion of the medicament has not been properly delivered. In this case, the signal processing unit can be configured to include data into the generated protocol data reflecting that a portion of the medicament has not been properly delivered.
  • the one or more predefined motion sequences can relate user defined gestures, wherein for each gesture the signal processing unit can be configured to include data into the generated protocol data related to the particular gesture.
  • the signal processing unit is configured to analyse generated protocol data and to determine a future adjusted dosage of the medicament and a future delivery of the adjusted dosage of the medicament.
  • the signal processing unit can be configured to store user data defining characteristics of the patient, such as age, weight, etc. and to determine a future dosage of the medicament based on user data.
  • the signal processing unit can be configured to activate a user interface of the device, to transmit a message to a remote device, etc.
  • the device is further configured to receive measurement data of a blood glucose level of a patient.
  • Measurement data can be received through a communication interface, a user interface, etc.
  • Measurement data can be based on a test-strip.
  • Measurement data can be evaluated in connection of a humidity sensor and/or a temperature sensor included in the device.
  • the invention relates to an injection pen comprising the inventive device for generating protocol data for an injection pen.
  • the inventive device is fixedly mounted to the injection pen.
  • the inventive device can be fixedly mounted to a dosing adjusting means of the injection pen and/or a delivery means of the injection pen.
  • Fig. 1 illustrates schematically an injection pen having mounted a device for generating protocol data for the injection pen
  • Fig. 2a illustrates schematically a side view of the device for generating protocol data of the injection pen
  • Fig. 2b illustrates schematically a top view of the device for generating protocol data of the injection pen
  • Fig. 3a illustrates schematically a perspective view of a front view of the device for generating protocol data of an injection pen
  • Fig. 3b illustrates schematically a perspective view of a back view of the device for generating protocol data of an injection pen
  • Fig. 4 illustrates schematically rotation of the device for generating protocol data of an injection pen
  • Fig. 5 illustrates schematically an acceleration signal of the rotation of the device versus time
  • Fig. 6 illustrates schematically the velocity signal and the integrated velocity signal of the rotation of the device versus time.
  • FIG 1 illustrates schematically an injection pen 2 having mounted a device 1 for gener- ating protocol data for the injection pen 2.
  • the injection pen 2 includes a medicament, such as insulin, for delivery to a patient via a needle (not shown in Figure 1 ) of the injection pen 2.
  • the injection pen 2 includes a dosing adjusting means (only partially shown as indicated by a dosage scale 21 in Figure 1 ) for adjusting a dosage of the medicament and a delivery means (not shown in Figure 1 ) for delivery of the adjusted medicament.
  • a dosage scale 21 of the injection pen 2 is shown, which is a part of the dosing adjusting means.
  • the device 1 for generating protocol data is fixedly or releasably mounted on the injection pen 2.
  • the device 1 includes a display of a user interface 1 1 which displays protocol data of the last injection performed with the injection pen 2, indicated by the string "6E", and the time since the last delivery of the medicament, indicated by the string "2h 30m”.
  • the injection pen 2 has essentially a cylindrical shape and defines an axis of rotation.
  • the device 1 for generating protocol data for the injection pen 2 is mounted to the dosage adjusting means 22 (only partially shown as indicated by a dosage scale 21 in Figure 1 ) and the delivery means 23 (not shown in Figure 1 ).
  • a patient adjusts the dosage of the medicament by rotating the device 1 relative to the injection pen 2 about the axis of rotation.
  • the adjusted dosage is displayed on the dosage scale 21 .
  • the patient delivers the dosage of the medicament by pushing the device 1 towards the injection pen 2, thereby activating the delivery means 23 (not shown in Figure 1 ) of the injection pen 2.
  • Figure 2a illustrates schematically a side view of the injection pen 2 having mounted the device 1 for generating protocol data of the injection pen 2.
  • Figure 2b illustrates schematically a top view of the device 1 for generating protocol data of the injection pen 2.
  • the device 1 includes an energy store 1 2, a motion sensing unit 1 3, a signal processing unit 1 4, a communication interface 1 5, and a user interface 1 6.
  • the device 1 is mounted to the dosing adjusting means 22 of the injection pen 2.
  • the device 1 is also mounted to the delivery means 23 of the injection pen 2.
  • the device 1 is rotatable about an axis of rotation defined by the cylindrical injection pen 2. Moreover, as indicated by arrow a3 the device 1 is pusha- ble towards the injection pen 2. By rotating the device 1 , the patient can adjust a dosage of the medicament, wherein rotation of the device 1 is transmitted to a rotation of the dosing adjusting means 22 of the injection pen 2. By pushing the device 1 towards the injection pen 2, the patient can initiate or perform delivery of the medicament, wherein the push movement of the device 1 is transmitted to a push movement of the delivery means 23 of the injection pen 2.
  • the injection pen 2 can be a commercially available injection pen designed for use without the device 1 for generating protocol data.
  • the device 1 can comprise a mounting arrangement which fits a wide variety of commercially available injection pens 2.
  • the mounting arrangement can include exchangeable adapters, each adapter being designed for mounting the device 1 to a particular type of a commercially available injection pen 2.
  • Figure 2b illustrates schematically a top view of the device 1 for generating protocol data of the injection pen 2.
  • Figure 2b illustrates schematically the display of a user interface 1 1 of the device 1 and a housing of the device 1 .
  • the user interface 1 1 of the device 1 can include an OLED display (OLED: Organic Light Emitting Diode), a TFT display (TFT: Thin-Film Transistor), a touchscreen, etc.
  • the energy store 1 2 of the device 1 can include a battery, an accumulator, etc.
  • the motion sensing unit 1 3 of the device 1 can include a MPU 9250 device from InvenSense® or another motion sensing unit.
  • the signal processing unit 1 4 can include a LPC541 02SMD microprocessor from NXP® or another signal processing unit.
  • the communication interface 1 5 can include a Bluetooth interface or a Bluetooth Low Energy interface.
  • Figure 3a illustrates schematically a perspective view of a front view of the device 1 for generating protocol data of an injection pen 2.
  • the front view illustrates a display of a user interface 1 1 of the device 1 .
  • Figure 3b illustrates schematically a back view of the device 1 for generating protocol data of an injection pen 2.
  • the back view illustrates a mounting arrangement 1 9 of the device 1 .
  • the mounting arrangement 1 9 is configured to mount the device on dosing adjusting means 22 and/or delivery means 23 of an injection pen 2.
  • Figure 4 illustrates schematically rotation of the device 1 for generating protocol data of an injection pen 2. Rotation can occur about an axis of rotation of the injection pen 2.
  • the signal processing unit 1 4 can be configured, based on signals received from the motion sensing unit 1 3, to analyse rotation based on a velocity of rotation of the device 1 and/or based on an acceleration of rotation of the device 1 .
  • the dosing adjusting means 22 of an injection pen 2 include a snap locking mechanism.
  • the snap locking mechanism can provide steps of 1 8°, for example, such that a full rotation of the device 1 respectively of the dosing adjusting means 22 corresponds to twenty steps.
  • the velocity of rotation after each step, i.e. upon release of the snap locking mechanism, the velocity of rotation increases rapidly for a short time.
  • the acceleration increases rapidly for a short time as well.
  • FIG. 5 illustrates schematically an acceleration signal of the rotation of the device 1 .
  • each step of rotation of the device 1 can be identified based on the acceleration signal.
  • the acceleration signal can be combined with a velocity signal (not shown in Fig- ure 5) in order to identify steps of rotation of the device 1 respectively of the dosing adjusting means 22.
  • Figure 6 illustrates schematically the velocity signal of the rotation of the device 1 versus time. A plurality of maxima is shown, wherein each maxima is followed by a minimum.
  • Figure 5 illustrates nine maxima and nine minima, indicating that the device 1 has been rotated by nine snaps of the dosing adjusting means 22 of the injection pen 2.
  • Figure 6 also illustrates schematically the integrated velocity signal of the rotation of the device 1 versus time. Nine steps is shown, wherein each step indicates that the device 1 has been rotated by a snap of the dosing adjusting means 22 of the injection pen 2.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
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  • Epidemiology (AREA)
  • General Business, Economics & Management (AREA)
  • Business, Economics & Management (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif (1) pour la génération de données de protocole pour un stylo injecteur (2). Le dispositif (1) comprend une unité de détection de mouvement (13) comprenant un gyroscope et/ou un accéléromètre. Le dispositif (1) comprend une unité de traitement de signaux (14) qui est configurée pour analyser un ou plusieurs signaux de l'unité de détection de mouvement (13) afin de générer des données de protocole correspondant à au moins une dose ajustée d'un médicament et à l'administration de la dose ajustée du médicament.
PCT/EP2017/066652 2016-07-18 2017-07-04 Dispositif de génération de données de protocole pour un stylo injecteur WO2018028886A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP16179861.6 2016-07-18
EP16179861 2016-07-18
EP16180031 2016-07-18
EP16180031.3 2016-07-18

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WO2018028886A1 true WO2018028886A1 (fr) 2018-02-15

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019167003A1 (fr) * 2018-03-01 2019-09-06 Copernicus Sp. Z O.O. Dispositif de surveillance de l'état d'un applicateur pour injecter un médicament et procédé de surveillance de l'état d'un applicateur au moyen dudit dispositif

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010098927A1 (fr) * 2009-02-27 2010-09-02 Lifescan, Inc. Module médical pour stylo de distribution de médicaments
WO2010112575A1 (fr) 2009-04-01 2010-10-07 Medimatik Gmbh Dispositif destiné à l'administration d'insuline hors d'une cartouche
WO2012001493A2 (fr) 2010-07-01 2012-01-05 Patients Pending Ltd Capuchon remplaçable pour un dispositif de dosage
EP2427236A2 (fr) 2009-05-06 2012-03-14 John Hughes Dispositif de supervision d'injection de médicament
WO2015136513A1 (fr) * 2014-03-14 2015-09-17 HUGHES, John Pascal Dispositif de surveillance
US20160030683A1 (en) 2013-03-15 2016-02-04 Becton, Dickinson And Company Smart adapter for infusion devices

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010098927A1 (fr) * 2009-02-27 2010-09-02 Lifescan, Inc. Module médical pour stylo de distribution de médicaments
WO2010112575A1 (fr) 2009-04-01 2010-10-07 Medimatik Gmbh Dispositif destiné à l'administration d'insuline hors d'une cartouche
EP2427236A2 (fr) 2009-05-06 2012-03-14 John Hughes Dispositif de supervision d'injection de médicament
WO2012001493A2 (fr) 2010-07-01 2012-01-05 Patients Pending Ltd Capuchon remplaçable pour un dispositif de dosage
US20160030683A1 (en) 2013-03-15 2016-02-04 Becton, Dickinson And Company Smart adapter for infusion devices
WO2015136513A1 (fr) * 2014-03-14 2015-09-17 HUGHES, John Pascal Dispositif de surveillance

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019167003A1 (fr) * 2018-03-01 2019-09-06 Copernicus Sp. Z O.O. Dispositif de surveillance de l'état d'un applicateur pour injecter un médicament et procédé de surveillance de l'état d'un applicateur au moyen dudit dispositif
US11623048B2 (en) 2018-03-01 2023-04-11 Nemera Szczecin Spolka Z Ograniczona Odpowiedzialnoscia Device for monitoring the state of an applicator for injecting a medicament and a method of monitoring the state of an applicator by means of said device

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