EP3426325A1 - Procédé pour vérifier l'état d'un médicament stocké dans un dispositif d'injection - Google Patents

Procédé pour vérifier l'état d'un médicament stocké dans un dispositif d'injection

Info

Publication number
EP3426325A1
EP3426325A1 EP17705059.8A EP17705059A EP3426325A1 EP 3426325 A1 EP3426325 A1 EP 3426325A1 EP 17705059 A EP17705059 A EP 17705059A EP 3426325 A1 EP3426325 A1 EP 3426325A1
Authority
EP
European Patent Office
Prior art keywords
injection device
therapeutic agent
insulin
injection
acceleration
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP17705059.8A
Other languages
German (de)
English (en)
Inventor
Janko Schildt
Markus BENTRUP
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Emperra E-Health Technologies GmbH
Original Assignee
Emperra E-Health Technologies GmbH
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 Emperra E-Health Technologies GmbH filed Critical Emperra E-Health Technologies GmbH
Publication of EP3426325A1 publication Critical patent/EP3426325A1/fr
Pending legal-status Critical Current

Links

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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • A61M5/3157—Means providing feedback signals when administration is completed
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01P—MEASURING LINEAR OR ANGULAR SPEED, ACCELERATION, DECELERATION, OR SHOCK; INDICATING PRESENCE, ABSENCE, OR DIRECTION, OF MOVEMENT
    • G01P15/00—Measuring acceleration; Measuring deceleration; Measuring shock, i.e. sudden change of acceleration
    • G01P15/14—Measuring acceleration; Measuring deceleration; Measuring shock, i.e. sudden change of acceleration by making use of gyroscopes
    • 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
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • 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
    • A61M2205/27—General characteristics of the apparatus preventing use
    • 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
    • A61M2205/3327—Measuring
    • 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
    • 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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile

Definitions

  • the invention relates to a method for checking the state of a in one
  • Injection device stored therapeutic agent.
  • Carbohydrates for example heparin, antibodies or most vaccines.
  • syringes, medication pens or drug pumps are predominantly used.
  • Insulin therapy provides a basic need for insulin, often through a slow and long-acting insulin, the basal insulin.
  • fast-acting insulin is injected.
  • the dose of the fast-acting insulin depends essentially on the carbohydrates absorbed.
  • the dose is thus selected depending on the external circumstances. Such circumstances include, for example, the time of day, range of motion, diet and the like.
  • Diabetes mellitus can have serious long-term consequences and body damage. These can be significantly reduced by a customized insulin therapy, preferably an intensified, conventional insulin therapy. A wrong dose can also have short-term consequences such as hypoglycaemia states. The best possible adaptation of the dose to the particular circumstances is therefore particularly desirable.
  • Such a protocol usually includes the measured blood glucose value, the amount consumed
  • Carbohydrates the insulin dose injected, and the date and time. From the log the treating physician or the patient can determine or adjust the respective dose. It is therefore important in particular to a high dosing accuracy of insulin.
  • a widely used injection device for injecting metered amounts of insulin is the so-called insulin pen. Unlike insulin syringes, the insulin pen uses a replaceable medication container. This container, also called carpule or ampoule, is supplied by the manufacturer with the insulin filled and before use in the
  • Insulin pen used. When the pen is put into operation, a needle pierces the ampoule sealing disc and realizes the parenteral injection of the preselected dose when the insulin is applied. An injection and release mechanism generates one during the injection
  • the mechanism usually consists of a piston rod with the Ampullenstopfenhub corresponding length.
  • Well-known insulin pens are similar to a thicker ballpoint pen. They include a
  • the ampoule is usually replaceable. However, arrangements are also known which are designed as disposable pens. The ampoules and their contents, dimensions and handling are not normalized. An ampoule of a manufacturer can therefore usually not be used in the pen of another manufacturer.
  • a pen comprises a metering device.
  • the required dose is set on a dosing button. This is then injected into the subcutaneous fatty tissue by means of an injection device, which may be formed on the surface or needleless.
  • Insulin pens are known in which the set dose is shown on a display instead of a mechanical indication on the dose knob. The display is powered by a voltage source integrated in the insulin pen. The patient can adjust the dose and record in his diabetic diary.
  • Insulin pens are known in which the protocol is automatically carried out in a recording device integrated in the insulin pen. This can be connected to a data processing unit via a data connection, which can be wired or wireless. With regard to the structure and function of such an insulin pen, reference is made to the disclosure of WO 2013/079644 A1. Insulin pens are divided into disposable and reusable insulin pens that can be used once. In one-time use insulin pens form the ampoule and the
  • Metering mechanism is a unit prefabricated by the manufacturer and are disposed of together after emptying the ampoule. Reuse of the metering mechanism is not provided. Reusable insulin pens place increased demands on the user. So when changing the ampoule, the piston rod must be reset to the start position. Depending on the model, this is done by turning or pushing the piston rod while simultaneously activating a special function in the dosing mechanism.
  • Reusable insulin pens are further subdivided into manual and semi-automatic insulin pens.
  • manual insulin pens the user actuates an injection button with his finger and thus determines the duration and course of the injection.
  • semi-automatic insulin pens on the other hand, a spring is manually clamped before use, which stores the necessary injection energy. In the actual injection process, the spring is unlocked by the user.
  • the therapeutic agent (insulin) present in the ampoules is usually used for a variety of injections. That is, with each injection, only a subset of the therapeutic agent present in the vial is injected. There are different lengths of time between injections. This leads to the fact that in the ampoules existing
  • Therapeutic due to the different densities of the active ingredients contained therein or fillers segregated. Thus, it is necessary that prior to each injection for adequate effect, a thorough mixing of the therapeutic agent must occur. Failure to do so may result in erroneous effects of the injected therapeutic.
  • US 2016/0030683 A1 discloses an injection device for injecting metered quantities of a liquid therapeutic comprising a sensor element. By means of this sensor element, various parameters of the therapeutic agent or the device itself can be detected and fed to an evaluation.
  • US 2005/043676 A1 discloses an injection device for injecting metered quantities of a liquid therapeutic comprising an acceleration sensor. This
  • Accelerometer is used to detect improper handling of the
  • Injection device through which the injection device is subjected to large impacts.
  • a drop of the injection device can be detected, which serves for internal damage of the device itself or one of the therapeutic agent receiving ampoule or the like. If an acceleration limit is exceeded, a not reversible display driven, which clearly indicates to a patient that the
  • Injection device was exposed to an impermissible mechanical stress.
  • the invention has for its object to provide a method of the generic type, with which can be detected in a simple manner, whether before an injection sufficient
  • Detection device evaluates a measured acceleration over time and at
  • Acceleration history of a movement of the injection device is recorded as a measure of the mixing of the therapeutic agent and is taken into account when logging the Therapeutikagabe. In this way, it is advantageously possible for both the patient and a physician who evaluates the proper administration of the therapeutic to have the corresponding information available. Overall, this makes a more optimal dosage of the therapeutic possible.
  • FIG 1 schematically an injection device
  • FIG. 1 schematically shows an injection device designated overall by 10. Structure and function of injection devices 10 are generally known, so that will not be discussed in the context of the present description. This can happen
  • injection device can also be a one-time or multiple-use injection device.
  • injection device with or without adapter for recording
  • the injection device 10 has a housing 12, within which a receiving device 14 for receiving a therapeutic agent to be injected, hereinafter is assumed to be insulin, is arranged.
  • the receiving device 14 may be an ampoule or carpule.
  • the injection device 10 further comprises an application device 16 for transferring the insulin to an injection site (application site).
  • the injection site is, for example, a skin area of a patient.
  • the application device 16 may have a pin needle 18 which is inserted into the skin of the patient.
  • the application device 16 is arranged exchangeably on the housing and pierces a membrane 20 of the receiving device 14 with the pin 18.
  • the injection device 10 further comprises a metering device 22, which has an actuating element 24 which is in operative contact with a plug 26 of the receiving device 14.
  • the metering device 22 is associated with a triggering device 28.
  • the triggering device 28 cooperates with the metering device 22.
  • the injection device 10 further comprises a dosing button 30, via which the dose of insulin to be injected can be set. Furthermore, a release button 32 is provided, which is operatively connected to the triggering device 28.
  • the injection device 10 further comprises a display 34, which is equipped with a display panel.
  • the injection device 10 further comprises a detection device 36, which via a
  • Interface 38 can be connected to a data processing system 40 merely indicated here.
  • the data processing system 40 also has an interface 42, which with the Interface 38 can communicate.
  • the connection can be wired or wireless.
  • the injection device 10 further comprises a motion sensor 60.
  • the motion sensor 60 is for example a so-called gyrosensor.
  • This has a sensitive device, for example, a suitably mounted seismic mass, with which it is detected whether the motion sensor 60 and thus the injection device 10 is moved in at least one spatial direction.
  • an acceleration in the three spatial directions can be detected by the motion sensor 60, which also result from turning, shaking, reciprocating and the like of the injection device.
  • the three spatial directions mean, on the one hand, the x-direction, which is herewith the longitudinal extension of the injection device 10 coincides. On the other hand, this is the y-direction, which coincides with the vertical extent of the
  • Injection device coincides and also the z-direction, with the depth of the
  • Injection device 10 (corresponding representation in Figure 1) coincides.
  • the motion sensor 60 is connected to the detection device 36 via a connecting line 62.
  • the motion sensor 60 and the connection line 62 may be integrated into the housing 12 of the injection device 10 so that they have a defined position with respect to the housing 12.
  • the injection device 10 shown in FIG. 1 has the following function:
  • the injection device 10 When the injection device 10 is used as intended, thorough mixing of the therapeutic agent (insulin) must be carried out before the actual injection. This thorough mixing serves to distribute the active ingredients in the storage container 14 evenly, so that a defined active substance can be produced during a subsequent injection.
  • the therapeutic agent insulin
  • the amount of insulin to be dosed is adjusted by means of the dosing button 30.
  • the set amount can be read on the display 34 and thus controlled.
  • the release button 32 is actuated. This is triggered by the triggering device 28 of the injection process by the actuator 24 of the Metering device 22 is acted upon by a driving force.
  • the actuator 24 displaces thereby the plug 26 within the receiving device 14, so that the
  • the injection device 10 detected.
  • the corresponding signals are supplied via the connecting line 62 to the detection device 36.
  • the detection device compares the signals supplied by the motion sensor 60 with empirical values stored in a memory unit and determines therefrom the degree of intermixing of the therapeutic (insulin) present in the recording device 14. In this case, an evaluation of the supplied signals both in terms of height (amplitude) and over time. Here, different evaluation criteria are stored. Generally speaking, the higher the amplitude, the higher the acceleration, the less the time required to achieve the desired degree of mixing.
  • FIG. 2 shows by way of example a measurement signal supplied by the motion sensor 60.
  • the acceleration a is plotted over the time t.
  • the acceleration a in the x-direction that is to say in the longitudinal extent of the injection device 10
  • the acceleration a in the x-direction should be represented here.
  • accelerations occur in the x-direction as well as in the opposite direction of the x-direction, ie positive and negative acceleration. These fluctuate around the zero line.
  • very different acceleration values over time will result.
  • the detection device 36 the measured signal is compared with at least one required signal value.
  • an expected signal value for the acceleration a1 is entered here. If it is now recognized that this limit a1 is repeated several times within a certain period of time,
  • tO is exceeded to t1
  • the detection device 36 will then generate a corresponding signal to the display 34 and then visually represent a sufficient mixing by a suitable symbol. Additionally or exclusively, an acoustic signaling can take place.
  • the detection device 36 may be designed so that upon detection of a
  • the corresponding signals can also be sent to the data processing layer 40 for later
  • Evaluation be transmitted by the patient and / or a doctor. Thus, it can be determined whether in the individual injections before actually a sufficient mixing has taken place. From this it is possible to deduce the actual active substance injection on the patient and to take this into account in the further therapy.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif d'injection (10) servant à injecter des quantités dosées d'un médicament liquide, comprenant un système de réception (14) destiné audit médicament, un système d'application (16) destiné au transfert du médicament sur un site d'application, un système de dosage (22) destiné au transfert du médicament du dispositif de réception (14) au dispositif d'application (16), un système de déclenchement (28) destiné à activer le système de dosage (22) et un système de détection (36) destiné à détecter la quantité de médicament appliquée. Selon l'invention, un système capteur comprend au moins un dispositif de détection qui permet de déterminer, avant une injection, si le médicament a été mélangé.
EP17705059.8A 2016-03-07 2017-02-08 Procédé pour vérifier l'état d'un médicament stocké dans un dispositif d'injection Pending EP3426325A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102016104101.7A DE102016104101A1 (de) 2016-03-07 2016-03-07 Injektionsvorrichtung zur Injektion dosierter Mengen eines flüssigen Therapeutikums
PCT/EP2017/052707 WO2017153112A1 (fr) 2016-03-07 2017-02-08 Procédé pour vérifier l'état d'un médicament stocké dans un dispositif d'injection

Publications (1)

Publication Number Publication Date
EP3426325A1 true EP3426325A1 (fr) 2019-01-16

Family

ID=58044041

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17705059.8A Pending EP3426325A1 (fr) 2016-03-07 2017-02-08 Procédé pour vérifier l'état d'un médicament stocké dans un dispositif d'injection

Country Status (8)

Country Link
US (1) US20190038844A1 (fr)
EP (1) EP3426325A1 (fr)
JP (1) JP2019507647A (fr)
CN (1) CN109069743A (fr)
CA (1) CA3014477A1 (fr)
DE (1) DE102016104101A1 (fr)
RU (1) RU2018135085A (fr)
WO (1) WO2017153112A1 (fr)

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10204119A1 (de) * 2002-02-01 2003-08-14 Disetronic Licensing Ag Vorrichtung zur dosierten Verabreichung eines injizierbaren Produkts
EP2349412B1 (fr) * 2008-10-01 2019-07-24 Novo Nordisk A/S Moyen de collecte de données pour dispositif médical
EP2384778B1 (fr) * 2009-03-04 2018-02-28 Panasonic Healthcare Holdings Co., Ltd. Dispositif d'injektion médicamenteuse pourvue d'un capteur d'acceleration
DE102009003721A1 (de) 2009-04-01 2010-10-07 Medimatik Gmbh Applikationsgerät
US9022988B1 (en) * 2010-05-07 2015-05-05 Kavan J. Shaban System and method for controlling a self-injector device
WO2011159930A2 (fr) * 2010-06-16 2011-12-22 Medtronic, Inc. Systèmes d'amortissement permettant de stabiliser des médicaments dans des dispositifs de distribution de médicaments
WO2013069305A1 (fr) * 2011-11-10 2013-05-16 パナソニック株式会社 Dispositif d'injection de médicament
DE102011055898A1 (de) 2011-11-30 2013-06-06 Emperra Gmbh E-Health Technologies Telemedizinische Anordnung für Diabetes Mellitus-Patienten
JP6209530B2 (ja) * 2012-11-22 2017-10-04 パナソニックヘルスケアホールディングス株式会社 薬剤注入装置、薬剤注入装置の制御方法、プログラム及び記録媒体
US10398852B2 (en) * 2013-03-15 2019-09-03 Becton, Dickinson And Company Smart adapter for infusion devices
KR20170035969A (ko) * 2014-08-19 2017-03-31 케어베이 유럽 리미티드 사용자 거동을 로깅 및 추적하기 위한 모션 검출기를 구비한 약물 주입 장치 또는 주입 모형 데모 장치

Also Published As

Publication number Publication date
RU2018135085A (ru) 2020-04-08
CA3014477A1 (fr) 2017-09-14
DE102016104101A1 (de) 2017-09-07
RU2018135085A3 (fr) 2020-05-14
CN109069743A (zh) 2018-12-21
JP2019507647A (ja) 2019-03-22
US20190038844A1 (en) 2019-02-07
WO2017153112A1 (fr) 2017-09-14

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