EP3426325A1

EP3426325A1 - Method for checking the condition of a therapeutic agent housed in an injection device

Info

Publication number: EP3426325A1
Application number: EP17705059.8A
Authority: EP
Inventors: Janko Schildt; Markus BENTRUP
Original assignee: Emperra E-Health Technologies GmbH
Current assignee: Emperra E-Health Technologies GmbH
Priority date: 2016-03-07
Filing date: 2017-02-08
Publication date: 2019-01-16
Also published as: US20190038844A1; WO2017153112A1; RU2018135085A3; CA3014477A1; DE102016104101A1; JP2019507647A; RU2018135085A; CN109069743A

Abstract

The invention relates to an injection device (10) for injecting dosed amounts of a liquid therapeutic agent, comprising a receiving system (14) for the therapeutic agent, an application system (16) for transferring the therapeutic agent to an application site, a dosing system (22) for transferring the therapeutic agent from the receiving system (14) to the application system (16), a trigger system (28) for activating the dosing system (22), and a detection system (36) for detecting the amount of the therapeutic agent applied. According to the invention, a sensor arrangement comprises at least one recognition system which detects, prior to injection, whether the therapeutic agent has been mixed.

Description

Method for checking the state of a stored in an injection device

therapeutic

The invention relates to a method for checking the state of a in one

Injection device stored therapeutic agent.

Many medicines (therapeutics) need to be injected into the body. This is especially true for those drugs that are inactivated when given orally or significantly lose effectiveness. In particular, proteins, such as insulin, pay for these drugs.

Carbohydrates, for example heparin, antibodies or most vaccines. For injection into the body, syringes, medication pens or drug pumps are predominantly used.

In insulin therapy, especially in the intensified, conventional insulin therapy, and conventional insulin therapy, insulin is not applied in constant amounts. Conventional insulin therapy uses insulin at certain times of the day. The daily routine of the patient depends on these times. In the intensified, conventional

Insulin therapy provides a basic need for insulin, often through a slow and long-acting insulin, the basal insulin.

At mealtime, 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.

For this reason, the diabetes mellitus patients are stopped for exact protocol about their habits and administered doses of insulin. 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

Injection stroke which causes the advancement of a plunger in the ampoule and causes delivery of the preselected dose to the target tissue. 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

Housing in which the insulin-containing ampoule can be accommodated. 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.

From EP 2 414 009 B1 an insulin pen is known, which allows an adapter arrangement for adaptation to ampoules of different dimensions and contents.

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. With manual insulin pens, the user actuates an injection button with his finger and thus determines the duration and course of the injection. With 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.

In this way, for example, 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

Thorough mixing of the therapeutic agent.

According to the invention the object is achieved by a method with the in claim 1

Characteristics solved. Characterized in that a movement of a housing of the injection device is measured, the measured movement corresponding signals of a detection device for detecting states of the injection device are transmitted, the

Detection device evaluates a measured acceleration over time and at

If a predeterminable limit value is exceeded, it is advantageously possible to determine a thorough mixing of the therapeutic agent. In other words, it becomes one

Provided mixing of the therapeutic, which generates a corresponding signal. This will enable a patient to know if he or she is being properly treated

Has achieved thorough mixing of the therapeutic agent prior to an injection. Overall, this ensures the required dose of therapeutic agents, at least increased.

In a further preferred embodiment of the invention, it is provided that a

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.

Further preferred embodiments of the invention will become apparent from the others, in the

Subclaims mentioned features.

The invention will be described below in an embodiment with reference to the associated

Drawing explained in more detail. Show it;

Figure 1 schematically an injection device and

Figure 2 shows an exemplary waveform. 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

for example, to act a needle-like or a needleless injection device.

It can also be a one-time or multiple-use injection device. In addition, the injection device with or without adapter for recording

be equipped with different ampoules from different manufacturers.

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. For this purpose, 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. In this case, in particular 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.

Structure and mode of action of such gyro sensors are well known, so that will not be discussed in the context of the present description. It is crucial that the corresponding gyrosensor the acceleration signals corresponding to the actual

Acceleration directions and the acceleration height of the injection device 10 provides.

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:

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.

For a desired injection, 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. After placing the injection device 10 with the pin 18 of the application device 16 on the skin of the patient to be treated, 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

desired set dose of insulin can be injected via the application device 16. Such a structure and such a function of the injection device 10 are known per se.

By means of the motion sensor 60 so the accelerations of at least one

Direction of space, preferably in all three spatial directions, 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. In this case the acceleration a is plotted over the time t. For example, the acceleration a in the x-direction, that is to say in the longitudinal extent of the injection device 10, should be represented here. By reciprocating the injection device 10, 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. Depending on the strength of the movement, very different acceleration values over time will result. By means of the detection device 36, the measured signal is compared with at least one required signal value.

For example, 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,

For example, tO is exceeded to t1, can be detected on a sufficient mixing of the therapeutic agent. 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.

Furthermore, the detection device 36 may be designed so that upon detection of a

sufficient mixing only one injection of the injection device 10 is released. 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.

Overall, it is achieved with the method according to the invention that the dosing accuracy is increased. Movements of the injection device 10 are certainly automatically detected as such and logged accordingly via the detection device 36. In the subsequent evaluation of the protocols by a treating physician can thus be focused on the actually applied amount of insulin in more detail.

reference numeral

10 injection device

12 housing

14 receiving device

16 application device

18 pin

20 membrane

22 metering device

24 actuator

26 plugs

28 triggering device

30 dosing button

32 release button

34 display

36 detection device

38 interface

40 data processing system

42 interface

60 motion sensor

62 connection line

Claims

claims

1 . Method for checking the condition of an injection device (10)

stored therapeutics,

characterized in that

a movement of a housing (12) of the injection device (10) is measured, the measured movement corresponding signals of a detection means (36) for detecting states of the injection device (10) are transmitted, the

Detection device (36) evaluates a measured acceleration (a) over time (t) and generates a signal when a predeterminable limit value (a1) is exceeded.

2. The method according to claim 1,

characterized in that

the signal is generated when the limit value (a1) is exceeded for a predetermined period of time (t1 minus t0).

3. The method according to any one of the preceding claims,

characterized in that

the signal is generated at least twice exceeding the limit value (a1) within a predefinable time duration (t1 minus t0).

4. The method according to any one of the preceding claims,

characterized in that

the acceleration history is recorded and when logging the

Therapeutic agent is considered.