Patent Application
20230256179
The invention relates to an apparatus for single administration of a medicinal product for medical treatment. The invention relates in particular to a medicament dispensing apparatus for self-medication.
Apparatuses for single administration of a medicinal product include, for example, pre-filled syringes or cartridges. These are often combined with auto-injectors so that the patient is able to administer the medicinal product from the pre-filled syringe or cartridge independently. Auto-injectors come in an electronic version with motor or else in a mechanical version.
An important safety requirement in apparatuses for single administration of a medicinal product is identifying whether or not the apparatus has been used already. This is done for safety reasons to prevent only some of the contents having been used already or the contents being contaminated. This is also done because the patient himself perhaps no longer remembers whether or not he has already used the apparatus fully or partially, and it is not readily identifiable from the outside that usage has taken place.
Electronic auto-injectors are known that contain systems for tracking the usage of the auto-injector. These systems gather and save data relating to the time of use, duration of administration, quantity of the administered medicinal product, and possible further data. If applicable, the data is also analysed and communicated to further devices. Or auxiliary units are proposed, which are connected to the auto-injector in order to gather data and to assist the user possibly with the intake, for instance by a reminder function that emits a signal to the user in the event of a certain time without usage.
WO2019/032784 A1 discloses, for example, a medicament dispensing system for a pre-filled syringe having an adapter which is attached to the medicament dispensing system and reads out information from a magnetic sensor. The magnetic sensor is attached to the housing of the medicament dispensing system or to the adapter. The medicament dispensing system has a plunger, which pushes the medicament out of the pre-filled syringe. A permanent magnet is attached to this plunger.
WO2018/195270 A1 discloses a method for tracking the use of an auto-injector by a patient, and a corresponding external electronic adapter, which can accommodate the auto-injector. The electronic adapter has a magnetic field sensor, which detects the magnetic field of a magnetic element situated on a moveable component of the auto-injector.
All these systems have in common that they are operated electronically and by battery. The usage status is determined in some cases by means of magnetic field sensors which measure a different magnetic field depending on whether a movement of two components relative to each other has taken place. If a movement has taken place, it is assumed that the system for the administration has already been used.
A trend in auto-injectors, for reasons of hygiene, are single-use auto-injectors that are disposed of after being used once. In order to conserve resources, single-use auto-injectors should not have any electronic components. Nevertheless, the safety requirement that the user can identify the status of usage of the system should also still be satisfied here.
The object of the present invention is to provide a system for identifying the usage status for apparatuses for single administration of a medicinal product, which system shall not have any electronic components.
The object according to the invention is achieved by an apparatus for single administration of a medicinal product. The apparatus may be a pre-filled syringe, or may be an auto-injector into which is inserted a cartridge or a pre-filled syringe, each of which may also be needleless. The apparatus according to the invention may also be a needleless syringe or a portable device such as a patch pump. Also conceivable are apparatuses consisting of a syringe and an auxiliary element or adapter. What is crucial is that in each case there is a first component and a second component, and the second component can move relative to the first component. The first component is called a “housing” below. The term “housing” includes, for example, a syringe body, an auxiliary element attached to the syringe body, or an auto-injector housing suitable for accommodating a pre-filled syringe or a cartridge (each optionally also needleless). The term “housing” also includes the housing of other mechanical injection systems. The second, moveable component may consequently be a syringe plunger or the plunger of an auto-injector. Also eligible as moveable components are further moveable elements of an auto-injector, for instance a drive spring or a needle shield, provided these elements experience a sufficiently large spatial displacement relative to the housing during administration of a medicinal product.
The apparatus according to the invention for single administration of a medicinal product has a housing and a second component arranged for movement relative to the housing. During the administration of the medicinal product, the second component shifts from a first position relative to the housing into a second position relative to the housing. Fixed on the housing is a first magnetic element, and arranged on the moveable component is a second magnetic element. In the first position the first magnetic element and the second magnetic element are close to one another, and in the second position the first magnetic element and the second magnetic element are spatially separated from one another, with the result that the magnetic field at the location of, or in the near field of, the first magnetic element is larger when the moveable component is in the first position than when the moveable component is in the second position.
Another embodiment of the apparatus according to the invention for single administration of a medicinal product has a housing and a second component arranged for movement relative to the housing. During the administration of the medicinal product, the second component shifts from a first position relative to the housing into a second position relative to the housing. Fixed on the housing is a first magnetic element, and arranged on the moveable component is a second magnetic element. In the first position the first magnetic element and the second magnetic element are spatially separated from one another, and in the second position the first magnetic element and the second magnetic element are close to one another, with the result that the magnetic field at the location of, or in the near field of, the first magnetic element is smaller when the moveable component is in the first position than when the moveable component is in the second position.
Each magnetic element produces a magnetic field. The strength M of magnetic fields decreases with increasing distance R from its origin according to the relationship M(R) ∼ 1/R2. The magnetic field strength at a location is composed of the magnetic field strengths of all the sources of magnetic fields acting at this location. The magnetic field sources situated farther away, however, make little to practically no contribution to the total magnetic field strength compared with the magnetic field sources situated close to the location. Therefore a significantly higher magnetic field is measured at a location, or in its near field, at which two magnetic field sources are situated close to one another than if only one of the two sources is situated there, and the second source is situated at a location lying further away.
Eligible as the first and second magnetic element for the apparatus according to the invention are, for example, a permanent magnet or magnetic particles, which in each case are attached to the surface of the housing or of the moveable component, are enclosed in or between housing parts or parts of the moveable component, are integrated in the material of the housing or of the moveable component, or are part of a label applied on the housing or the moveable component. Preferably, the first and second magnetic elements have the same magnetic characteristics, so for instance are both permanent magnets made of the same material (NdFeB, Bismanol, ferrites) having the same magnetic field strength.
The measurement of the magnetic field strength at a predetermined position on the apparatus according to the invention is performed by means of a magnetic field sensor, which is not part of the apparatus for single administration of the medicinal product. Typical magnetic field sensors are Hall sensors. The magnetic field sensor is part of a separate device that has the functionalities of a computer. The position at which, or in the proximity of which, the magnetic field strength is measured is preferably indicated externally on the housing. Another possible option for the indication is advice on the local region of the measurement via an interface of the separate device for the user (graphical user display or the like) or via operating instructions.
The separate device has at least the following features:
The measured value being coincident with a stored value range means that the measured value lies on, or within, the limits of the value range. The value range may also consist of one or more single values.
The separate device may be a conventional smartphone, tablet computer or a smartwatch etc. as long as it has a magnetic field sensor, for instance a Hall sensor. This is the case, for example, if the device has a compass function. It is well known that devices such as a smartphone or smartwatch comprise the functionalities of a computer as standard. Via the interface with the user, for instance via a display, icon, loudspeaker, audio output, an optical, visual, haptic (vibration) signal corresponding to the “used” or “unused” status can be given to the user. Via the communications interface, a signal can be sent to a further digital (terminal) device. The processor can be programmed also via an application, which is loaded onto the separate device.
The invention also relates to a computer-implemented method,
comprising the steps of:
The invention also relates to a computer program product comprising the commands which, when executed by a computer connected to a magnetic field sensor, cause this computer to perform the following method steps:
The computer program product may be an application for a smartphone, tablet computer or a smartwatch, etc.
The invention is explained more fully below in conjunction with preferred embodiments and with reference to the drawings.
Some preferred embodiments of the invention are presented in the following examples. It should be stressed, however, that the invention is not restricted thereto, but may be embodied in other ways within the subject matter defined in the claims.
For the sake of clarity, the figures are schematic and simplified. They show only details that are essential to the invention, while other details have been omitted. The same reference numbers are used throughout for identical or equivalent parts.
In the present example, the device having the magnetic field sensor is a smartphone. The smartphone contains a compass and is thereby suitable for detecting magnetic fields. An application that has been loaded into the smartphone controls the measurement of the magnetic field strength by the magnetic field sensor and the processing of the measured values.
The measurement of the magnetic field strength is performed at, or in the proximity of, an indicator 350 on the housing 101 of the auto-injector 100. The first magnetic element 310 is situated here on the inside of the housing 101. The smartphone display is brought into the region of the indicator 350 on the housing 101 or into the vicinity of the housing 101 of the auto-injector 102, and the value of the magnetic field Mx is detected. The indicator 350 advises the user as to exactly where the smartphone with its display is meant to be placed on, or close to, the housing 101. It is important to perform every measurement of the magnetic field strength within a certain proximity of the location of the first magnetic element 310 so that the measurements are comparable. Instead of the display, another predetermined part of the smartphone can also be brought into the proximity of the indicator 350 for the measurement. The indicator 350 on the housing 101 may be, for example, a marker on the outside of the housing 101 or an adhesively attached label.
By means of the application, value ranges [M1.... M2] for magnetic fields which correspond to the strength range of the magnetic field of the magnetic element 310 have been stored in the memory of the smartphone. A strength range because the measured values can have a certain spread depending on the distance of the magnetic field sensor from the magnetic element 310. Similarly, in the memory of the smartphone have been stored value ranges [M3.... M4] for magnetic fields which correspond to the strength range of the summated magnetic field of the magnetic elements 310 and 320 when these are situated close to one another.
The processor of the smartphone is programmed by the application to compare the measured value Mx from the magnetic field sensor with the stored value ranges [M1.... M2] and [M3.... M4] for magnetic fields. If measured value Mx lies in one of the stored value ranges [M1.... M2] or [M3.... M4], the smartphone emits a corresponding signal to the user. For example, on the display can appear the words “Already used” if the measured value Mx lies in the value range [M3.... M4], or the word “Unused” if the measured value Mx lies in the value range [M1.... M2]. Alternatively, the smartphone can start to vibrate as a sign for “used” if the measured value Mx lies in the value range [M3.... M4], and can make a triad sound if the measured value Mx lies in the value range [M1.... M2]. Numerous variants are conceivable here.
The measurement and processing of the magnetic field strength is performed as in Example 1A by means of a smartphone. In this exemplary embodiment, the identifier 350 is situated in the region of the distal end of the viewing window 120, where the first magnetic element 310 is situated on the inside of the housing 101. Unlike example 1A, in this exemplary embodiment, the smartphone application is programmed such that a signal corresponding to the “used” usage status is emitted to the user if the measured value Mx lies in the value range [M1.... M2]. A signal corresponding to the “unused” usage status is emitted if the measured value Mx lies in the value range [M3.... M4].
As shown in
The measurement and processing of the magnetic field strength is performed as described in Example 1A by means of a smartphone. In this exemplary embodiment, the measurement position 351 is situated in the vicinity of the flange, as indicated by the dashed line. Alternatively, the measurement position 203 could also be situated directly on the flange 203. Determining the usage status of a ready-to-use syringe 200 by means of a magnetic field sensor is also expedient even if it can be seen from the ready-to-use syringe 200 that it has been used. For instance the usage data can thus be captured immediately electronically and used for tracking the medicament dispensing.
The measurement and processing of the magnetic field strength is performed as described in Example 1A by means of a smartphone. In this exemplary embodiment, the measurement position 351 is situated in the region of the outlet end 204 in the vicinity of the external wall of the syringe body 201 but not directly on the external wall, as indicated by the dashed line. Alternatively, the measurement position 203 could also be situated directly on the housing 201. Determining the usage status of a ready-to-use syringe 200 by means of a magnetic field sensor is also expedient even if the ready-to-use syringe 200 is visible per se, and it could also be seen from the position of the syringe plunger rod 210 whether or not the ready-to-use syringe 200 has been used. By means of the described procedure, the usage data can be captured immediately electronically and used for tracking the medicament dispensing. The described procedure can also offer advantages to the visually impaired.
| Number | Date | Country | Kind |
|---|---|---|---|
| 20180180.0 | Jun 2020 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/065413 | 6/9/2021 | WO |
