CH717022A2 - Administration device with readable code. - Google Patents

Abstract

The invention relates to an administration device (1) for pouring out a dose of a product from a reservoir (11). The administering device (1) comprises a housing (2), a dispensing element (6) which can be moved relative to the housing (2) in a dispensing direction for dispensing the product and a machine-readable optical code area (4) which represents data that can be distinguished in the dispensing direction, the data are coded. The code area (4) is fixed to the housing. Before or after a dispensing movement of the dispensing element (6), a surface (36) of the dispensing element (6) overlaps at least partially with the code surface (4), so that the code surface (4) has an overlapped area which comes from outside the administration device (1) cannot be read out, and has a non-overlapping area which can be read out, the readable area being variable during the dispensing movement. The data include position information so that an instantaneous position of the shaking element (6) relative to the housing (2) can be determined by at least partial reading of the readable area.

Description

TECHNICAL AREA

The present invention relates to the field of medical administration devices for administering liquid substances, in particular drugs or medicinal substances such as insulin and hormone preparations. The invention relates to an administration device with an optical, machine-readable code surface which represents coded data.

BACKGROUND OF THE INVENTION

Different administration devices, ie injection systems and infusion systems, are known from the prior art, which can support patients in a controlled subcutaneous or intramuscular administration of a dose of a medicinal substance from a reservoir. While in infusion systems a cannula remains in the patient's body for a long time, injection devices are removed from the injection site after each delivery.

For self-medication, administration devices in the form of pens with an adjustable dose are often used. Such an injection pen has an elongated housing with a distal end for receiving a cannula or hollow needle and with a proximal end facing away from the injection site. An injection pen can be designed as a single or multiple use injection pen. The injection pen can also be operated automatically or manually. In order to monitor correct administration or to detect incorrect manipulation, the set dose can be automatically recorded by sensors. However, it is even better to record the dose actually administered. For this purpose, an element of the dispensing mechanism of the administration device, such as a piston rod, a drive sleeve or the stopper in a carpule, can be monitored or the position of the dispensing element during or after the injection can be recorded. Different approaches for detection are known from the prior art.

US Pat. No. 9,192,728 B2 discloses an injection pen with an integrated electronics unit which comprises a piston rod with a piston rod element with an optical code. An optical sensor in the injection pen detects the code and forwards the sensor signals to the electronics unit, which can thereby determine the rotative position of the piston rod relative to the housing of the injection pen. Due to the rotative position, the axial position of the piston rod relative to the housing and thus the amount of medication that has already been poured out of the carpule can be calculated.

US 10,426,889 B2 discloses a drug pump with a piston rod for dispensing the drug from a carpule. Notches or other optical markings are made on the piston rod, the pattern of the markings not being repeated over the entire length. An image sensor arranged in the pump near the piston rod can thereby detect an absolute position of the piston rod relative to the pump housing.

WO 2013/004844 AI describes an injection pen which comprises a dispensing mechanism with a sleeve with a circumferential code. An area of the code is visible from the outside through an opening in the housing of the pen. An add-on that can be detachably attached to the injection pen comprises an optical sensor which can read the code through the opening. When pouring out the sleeve rotates and the sensor can detect the rotation of the sleeve accordingly. This allows the movement of the piston rod and the amount of medication to be calculated.

In the patent application WO 2017/147202 an injector is disclosed which comprises a code. A first part of the code is arranged on an outside of the housing and a second part of the code is arranged on an actuating element that can be moved relative to the housing. The code can only be read with a smartphone when the actuating element is moved towards the housing when it is being poured out, and the first and second parts of the code are therefore next to each other. An optical sensor can thus be used to detect whether an administration has been carried out with the injector.

Such known devices for detecting the position of the piston rod or the electronic detection of the dispensed dose require either an external add-on with sensors and an evaluation unit or a sensor and evaluation unit integrated in the injector. With the arrangement according to WO 2017/147202, only one final state, i.e. not poured out or poured out, can be detected. It is not possible to detect a specific position of the piston rod between these end states.

DISCLOSURE OF THE INVENTION

It is an object of the invention to enable simple acquisition of data relating to a dose dispensed with an administration device.

This object is achieved by an administration device and a method according to the independent claims. Preferred embodiments are the subject of the dependent claims.

According to the invention, an administration device comprises a dispensing element which can be moved in a dispensing direction relative to a housing of the administration device for pouring out the product from a reservoir held in the administration device. The administration device comprises a machine-readable, optical code area which represents data, in particular injection data, the data being coded. According to the invention, the code area is fixed to the housing (i.e. immovable relative to the housing of the administering device) and represents data that can be distinguished along a dispensing direction. The dispensing element is arranged relative to the code area in such a way that before and / or after (and preferably also during) a dispensing movement of the dispensing element, an area of the dispensing element overlaps the code area at least partially or in areas. As a result, there is an overlapped area on the code area which cannot be read from outside the administration device, and a non-overlapped area which can be read from outside the administration device, the readable area during the dispensing movement (e.g. an axial displacement of the piston rod, a drive sleeve or of the plug in the carpule) is variable. The data include position information so that a current position of the shaking element relative to the housing can be determined by at least partial reading of the readable area.

According to the invention, an area of the dispensing element overlaps an area or a section of the code area. This area cannot be read from the outside, while the non-overlapped, readable area is visible from outside the administration device and can be read out with an external user device. The size of this readable area changes when pouring out, in that the movable pouring element optically releases an area or overlaps an area and thus influences it optically, for example by covering it or reducing or changing the contrast so much that the area can no longer be read out or is distinguishable . During the pouring out, the readable area of the code area gradually becomes larger or smaller or the code area becomes completely visible and readable or it can no longer be read out completely or can be read out in a distinguishable manner.

As a result, a specific area or section of the code area can be read out for discrete positions of the shaking element. Since the code area represents distinguishable data in the direction of delivery (and preferably in the longitudinal direction of the administration device), corresponding data with position information can be read out for these discrete positions of the delivery element before and after an injection, preferably also during an injection. The distribution element acts like a pointer on a scale or a data field.

The code area can preferably be read with an external user device, which is not physically connected to the administration device or cannot be connected, with an optical sensor of the user device. The position data read out can be decoded, further processed and evaluated with a computer program. The position of the shaking element relative to the housing of the administering device can thereby be determined. Based on the position of the shaking element, d. H. Depending on how far, for example, a piston rod, a drive sleeve or a stopper has been displaced in the distal direction, conclusions can be drawn about the amount of product poured out of the reservoir. This information can then be displayed to the user or transmitted to another recipient.

Since the user detects the readable area of the code area, for example after each injection, and forwards it to an external recipient, the latter can monitor the administrations and thus the adherence. The coded data of the code area can be read out with an external user device such as a smartphone, a tablet computer, a smart watch or another portable computer. There is therefore no need for an injector-specific add-on or additional electronic device with sensors which has to be attached to the administration device or otherwise physically connected to it. As a result, costs for such an additional device can be avoided.

As a result, the user of the administration device can use his already existing user device and does not have to specifically mount an add-on or an additional sensor unit on the administration device. In addition, the administration device itself does not have to be equipped with sensors and an evaluation unit, which simplifies and reduces the cost of its manufacture.

Since the pouring element delimits a readable area and not always the entire code area can be read out, incorrect position data which do not match the position of the shaking element can also not be read out by mistake or through deliberate manipulation.

Thus, by reading out the readable area of the code area fixed to the housing, the position of the dispensing element and thus the amount dispensed can be determined in a simple manner.

The term “administration device” is understood to mean an injection device or an infusion device. In the present description, “injection device” or “injector” is understood to mean a device in which the injection needle is removed from the tissue after a controlled amount of the medical substance has been dispensed. Thus, in the case of an injection device or injector, in contrast to an infusion system, the injection needle does not remain in the tissue for a prolonged period of several hours.

The administration device can be designed as an injection pen with a reservoir in the form of a carpule or as an autoinjector with a reservoir in the form of a prefilled syringe. The administration device is preferably a single or multiple use injector or patch injector. This can be designed as a manual injection pen, as an autopen or as an autoinjector with a spring-assisted or spring-driven dispensing mechanism. As an alternative to this, there is also the possibility that the administration device is designed as an infusion system in the form of a portable infusion pump or a patch pump. The administering device preferably comprises a housing which receives a dosing and dispensing mechanism and a reservoir holder which holds a reservoir immovable relative to the housing. An injection needle or injection cannula can advantageously be attached to a distal end of the administration device.

The dispensing element is preferably a movable element of a dispensing mechanism for pouring out the product held in the reservoir or a movable element of the reservoir held in the administration device. It can be, for example, the piston rod, a flange, a dispensing or drive sleeve or the stopper within a reservoir in the form of a carpule.

The code area is an optoelectronically detectable or machine-readable, one- or multi-dimensional pattern such as a black and white barcode, bar code, barcode, a data matrix code or any other pattern made up of several black and white or colored geometric elements that represents coded data . The position information can also be represented multiple times or redundantly by the code area so that error-free reading is made possible. In addition to the position data, the code area can also include information on the transmission of the data, for example a parity bit, which is used to check whether the data in the code area has been completely transmitted. Furthermore, the position data can be represented by the code area in such a way that the position information can be calculated by a software application from the read data, even if the data record is incomplete, for example if the code area is damaged or the transmission was briefly interrupted.

The code area represents coded data which can be optically captured by an external user device. Such an external device is e.g. a smartphone with a barcode reader, a camera and / or a QR code reader. Machine-readable means that the data can be recorded by an optical sensor. The data of the code area are coded. This means that the data cannot be read by humans without electronic support and is mainly not represented by alphanumeric characters. The meaning of the term “code area” is not limited to a two-dimensional area, but can also include a three-dimensional structure, for example.

According to the invention, the code area is fixed to the housing. This means that the code area cannot be moved relative to an outer housing of the administration device. However, it does not have to be arranged on the housing itself. For example, it can be located on a reservoir or carpule holder held immovably relative to the housing, on a carpule held in the carpule holder or on some other element that is immovable relative to the housing (fixed to the housing).

The encoded data include position information which indicates a position relative to the housing of the administration device. These can be, for example, scale values, length specifications, absolute values or also fill levels which represent a position of the shaking element in relation to the fill level of the reservoir.

According to the invention, a surface of the dispensing element overlaps the code surface. This means that the dispensing element can be located radially in front of or on the code area or radially behind a (in particular transparent) code area. The dispensing element thereby delimits a readable area of the code area from the entire code area. The entire code area is thus divided into a readable area and a non-readable area. The area that cannot be read out is covered by the dispensing element, for example, or, in contrast to the area that can be read out, it is difficult to see, or it is less clearly visible or with less contrast. Alternatively, the non-readable area can also have a distinguishably changed, for example inverted, contrast. The readable area can be read from outside the administration device by an external user device. This advantageously covers all or part of the readable area of the code area together with the dispensing element. The position of the dispensing element can be determined by reading out - e.g. a position value represented next to the dispensing element in the code area - and recording the dispensing element (e.g. the area of the dispensing element, a distal edge or another marker on the dispensing element) with an external user device. In order to read out the position data necessary for the position determination, the entire readable area is therefore preferably not required.

Since the dispensing element moves during an injection, the readable area and the non-readable area are changed. For example, during the pouring out movement, the readable area is successively enlarged and the non-readable area of the code area is reduced, or the readable area is reduced and the non-readable area is enlarged, or the readable or non-readable area is shifted as a constant or variable section on the code area .

The term “product”, “drug” or “medicinal substance” in the present context includes any flowable medical formulation that is suitable for controlled administration by means of a cannula or hollow needle into subcutaneous or intramuscular tissue, for example a liquid, a solution, a gel or a fine suspension containing one or more medicinal active ingredients. Thus, a medicament can be a single agent composition or a premixed or co-formulated multiple agent composition from a single container. The term includes in particular drugs such as peptides (e.g. insulins, drugs containing insulin, GLP 1-containing and derived or analogous preparations), proteins and hormones, biologically obtained or active substances, substances based on hormones or genes, nutritional formulations, enzymes and other substances in solid (suspended) or liquid form. The term also includes polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable basic, auxiliary and carrier substances.

The term “distal” denotes a side or direction directed towards the front, penetration-side end of the administration device or towards the tip of the needle or cannula. In contrast, the term “proximal” denotes a side or direction directed towards the rear end of the administration device opposite the insertion-side end.

In a preferred embodiment, the position information includes a length scale aligned in the discharge direction. This can have an even or uneven division. The length scale is preferably formed by code elements of the code area. The code area thus comprises code elements that are changed step-by-step in the distribution direction or a continuous code that changes step-by-step.

Depending on the desired resolution, the code area is designed so that one or more code elements represent a specific position relative to the housing. If a code element is read out together with the dispensing element, in particular a code element adjacent to the dispensing element, the current position of the dispensing element relative to the housing can be determined particularly reliably and quickly using the decoded position data. Since the code area advantageously changes the discharge direction step by step, the position of the discharge element can be determined simply and reliably over the entire path or over the entire discharge stroke.

The code area advantageously includes absolute position data, so that no incremental counting or storage is necessary. The position determination is therefore less prone to errors. Such absolute position information can be represented, for example, by means of a constantly changing code such as, for example, a Gray code.

Alternatively, there is also the possibility that the code area does not have a length scale, but only represents fixed states such as an initial position or an end position after pouring out.

A scale division of the length scale is preferably designed so that a distance between two successive scale division markings is equal to or smaller than a distance to be covered by the dispensing element in order to dispense the smallest dispensing dose. As a result, the smallest detectable change in position of the shaking element corresponds at most to the smallest dose that can be poured out. Each dose that can be dispensed with the administration device and each possible position of the dispensing element can thus be reliably detected. If, for example, a reservoir contains 300 units of a medicament to be administered, the length scale preferably has at least 300 divisions, which are represented by the code area.

The length scale is preferably scaled in such a way that a distance between two successive scale graduation markings is less than half as large as a distance to be covered by the dispensing element in order to dispense the smallest dispensing dose. This fulfills the sampling theorem, which can reduce the risk of incorrect detection.

The code area advantageously contains a two-dimensional code. This is preferably made of black and white or different colored elements. In contrast to a one-dimensional code, the data in the two-dimensional code are encoded not only in one direction, but in a first direction and in a second direction, which is preferably orthogonal to the first direction. The two-dimensional code enables the coded data to be displayed in a space-saving manner. Examples of a two-dimensional code are QR code, DataMatrix, Aztec code, JAB code, Han Xin code, MaxiCode, PDF417, Codablock and Code 49.

More preferably, the code area can have a JAB code with several colors, for example with eight colors, which enables a data density that is three times higher than that of black-and-white codes.

The code area with the two-dimensional code preferably has code elements arranged in the discharge direction and in a direction orthogonal to the discharge direction. As a result, many individual discrete position values can be represented in coded form along the discharge direction. This enables a high resolution to be represented in coded form.

In a particularly preferred embodiment, the two-dimensional code comprises a plurality of one-dimensional bar codes strung together, which are aligned in a direction orthogonal or inclined to the discharge direction. The code area advantageously includes at least as many individual barcodes as there are possible discrete positions of the shaking element. Thus, a single one-dimensional barcode represents a clearly defined position of the shaking element relative to the housing. In order to detect the position of the dispensing element, in this case only the barcode currently adjacent to the dispensing element has to be read out and decoded. The barcodes further away from the distribution element do not have to be decoded. In contrast to this, in the case of a data matrix, for example, the entire matrix must be read out in order to be able to decode the data.

The code area with the two-dimensional code is preferably curved. As a result, the code area can be attached particularly easily to an administration device that is essentially round in cross section, in particular on a pen-shaped administration device.

As an alternative to this, there is also the possibility that the code area comprises only a one-dimensional code such as, for example, a bar code.

The two-dimensional code preferably represents a binary code. The position data are thus stored in binary code in the code area. Due to its simplicity, the binary code can be read out, transmitted and further processed with simple means and few resources. The binary code can, for example, represent the position information in the form of scale or length values. Examples of binary codes are ASCII code, dual code, BCD code or Braille code. The code can have redundancy which can be used for error detection or error correction. Such redundancies can be implemented, for example, with a check bit, a checksum, CRC or Hamming codes.

The code area is advantageously arranged on a carpule holder of the administration device. In this case, the reservoir is designed as a carpule, which is held immovably by the carpule holder relative to the housing. The carpule holder can be connected to the housing in a detachable or non-detachable manner. The code area is preferably attached to an outside of the carpule holder. In this case, the dispensing element is preferably formed by the stopper which can be displaced within the carpule. The carpule holder is preferably designed to be transparent, so that the readable area can be detected and read out together with the stopper from outside the administration device. In this version, the area that cannot be read is the area behind which the stopper is located when viewed from the outside. Adjacent (left and right) to the stopper is the readable area of the code area, which can be recorded by the external user device.

In an alternative embodiment, the code area is arranged on an inner wall of an interior of the carpule holder. In this case, the carpule holder has a viewing window or is designed to be transparent so that the code area can be seen and read from the outside. The product in the form of a preferably liquid substance in the carpule acts as a lens, so that the code area that can be read from the outside through the liquid medicament is shown enlarged. This can simplify reading out with an external device.

In a preferred embodiment, the administering device additionally comprises an identification code which can be read out together with the readable area and comprises encoded data for identifying the administering device and / or the product. As a result, the administering device and / or the product in the administering device can also be identified each time the coded data of the code area is read out. This means that the data read out from the code area are uniquely and unmistakably linked to a specific administration device and / or to a specific product (medical substance, drug). It can thereby be ensured that the data read out are assigned to the correct administration device, the correct product or the correct user during further processing. This further increases the reliability of the data collected, since it is clear which dose was distributed with which administration device.

Examples of data for identification are information on the type, configuration of the administration device, in particular information on the dose step size or maximum number of dose steps that can be delivered name or designation, active ingredient concentration, amount of the product in the reservoir, expiry date of the product, manufacturer or lot number or user-specific data which uniquely identify a specific user. An effective amount of medicament administered can be determined, for example, by linking the dose step data of the administration device with the active ingredient concentration of the product.

The identification code is preferably located on an outside of the housing of the identification device. Alternatively, the identification code can also be located on the carpule holder, the carpule or some other external element of the administration device.

The identification code is preferably designed as a machine-readable or optically detectable code, in particular as a one- or two-dimensional barcode. A data matrix or a QR code, for example, can be used as the two-dimensional code. Such an identification code enables quick and easy detection and decoding with a user device. The identification code can also be designed as a marker in order to form a reference point for the optical sensor of the user device. As a result, the sensor that reads out the code area can detect the spatial alignment of the injection pen, so that the code area can be read out safely and reliably.

The identification code is preferably a code according to a standardized identification system, in particular the “Identification of Medicinal Products” (IDMP).

The optical identification code is advantageously placed near the code area, so that the code area as well as the identification code can be detected together by the optical sensor. If the code area is arranged on the carpule holder, the identification code can also be attached, for example, to the carpule holder or to an adjoining outer area of the housing.

In an alternative embodiment, the identification code is not designed as an optical code but in the form of an electronic transmitter, a radio label or a transponder. In this embodiment, the identification data can be read out wirelessly with the user device before, during or after the optical readout of the readable area of the code area. The reading is preferably carried out by means of wireless short-range communication such as Bluetooth, RFID or NFC. In a preferred embodiment, the identification device on the housing comprises a transponder which can be read in by the external user device and which comprises data on the administration device and / or the product. The data of the code area are advantageously read out together with the data of the transponder, so that the data of the code area can be clearly assigned to the data of the identification code.

In a further preferred embodiment, the coded data include, in addition to the position data, instructions for automatically executing a computer program on the user device. When the user captures the readable area with his user device and reads out the data, a user application or other computer program is started on the user device based on the decoded instructions. In this way, for example, the read data can be automatically decoded, further processed, displayed and / or transmitted to a further recipient. In addition, based on the instructions from the decoded data, a user program such as a therapy plan or therapy diary can also be activated or started automatically on the user device.

In a preferred embodiment, the dispensing element is a stopper which can be displaced within the reservoir in a distal direction in order to dispense the product from the reservoir. The reservoir is preferably designed as a cylindrical carpule. Furthermore, in this embodiment, the code area is preferably arranged on the carpule holder, which includes a viewing opening or is made of transparent material, so that the stopper and the code area can be optically detected from outside the administration device.

In an alternative embodiment, the dispensing element is a piston rod or a flange of the administration device. In this case, the housing has an opening or the housing is designed to be transparent, so that the piston rod or the flange can be optically detected from outside the administration device. In this embodiment, the code area is arranged on the housing itself or on an element fixed to the housing, with areas of the code area being readable or non-readable depending on a position of the piston rod or the flange. The readable area of the code area and the piston rod or the flange can be detected from outside through the opening in the housing or through the transparent housing.

The invention further relates to a computer-implementable method for determining the position of the shaking element relative to the housing of the administration device described above. The procedure consists of the following steps: optical reading of the readable area of the code area by means of a camera of the external user device; Decoding and evaluating coded data of the read area; Determining a position of the shaking element relative to the housing based on position information from the evaluated data.

The method advantageously further comprises adding current time information to the decoded position information, in particular adding the current time and date. This means that the recorded data are clearly identified during further processing and analysis and can be saved chronologically.

[0057] Information about dose deliveries that have taken place or are still possible for a product from the reservoir can preferably be derived from the recorded data.

The invention further comprises a computer program (software) which comprises instructions which, when the program is executed by a computer, cause the computer to carry out the steps of the above method.

In a preferred embodiment, the position of the shaking element is determined using the user device. As a result, the decoding of the data, the evaluation of the data, the determination of the position of the shaking element and any display of the evaluated data can take place directly with the user device. From the position of the shaking element and other data, for example, the dose administered or a product reserve that is still available can be calculated. The user device is, for example, a smartphone, a tablet computer, a smart watch, a notebook or another portable computer.

Alternatively, there is also the possibility that the data are only read from the user device and then transmitted to an external receiver, the decoding and evaluation of the data and the determination of the position of the shaking element being carried out by the external receiver. For this purpose, the data can be transmitted, for example, to a data cloud, to a server or to a computer system, for example of a health facility, an insurance company, a drug manufacturer or a treating person.

A computer program for carrying out the method thus includes both computer applications on the user device for reading in as well as computer applications on an external server for decoding and evaluating the data and determining the position of the shaking element.

In a preferred embodiment, the method additionally comprises the release of the data by the user in order to transmit the data. In this case, the data is decoded on the user device and displayed to the user. Only when the user confirms that the data may be transmitted to an external recipient will the data be transmitted from the user device to the external server or a data cloud.

The invention further comprises an administration device for dispensing a dose of a product from a reservoir held in the administration device. The delivery device comprises a housing; a dispensing element movable in a dispensing direction relative to the housing for dispensing the product; an optical, machine-readable code that represents data. The code is arranged on the dispensing element. The administration device is characterized in that the code is not visible and cannot be read from outside the administration device before an injection and is visible and readable from the outside after a dispensing movement of the shaking element.

This means that the code can only be read out when the dispensing movement of the dispensing element and thereby the injection have taken place. For example, the user can read the code with a user device such as his smartphone and send it to an external recipient. This recipient receives a confirmation that the injection really took place, as the code can only be read after the dose has been poured out.

Thus, no special additional module with sensors or no additional sensors in the administration device is required to detect the discharged state, since the user can use his existing user device to detect the state by means of the code.

The machine-readable code represents data, which is preferably encoded. This means that the data are mainly not represented by alphanumeric characters and cannot be read by a person without electronic assistance. Examples of a machine-readable code are one- or multi-dimensional patterns made up of black and white or colored elements such as a barcode, a two-dimensional data matrix or a QR code. Alternatively, however, there is also the possibility that the data are not coded and include numbers and letters so that they can be easily read by a person. Such a code can be, for example, a serial number made up of numbers and / or letters.

Before an injection, the code is not visible and cannot be read out by an optical sensor. The code is preferably concealed before an injection, for example by an element of the administration device. After a dispensing movement of the dispensing element, that is to say after an injection and the administration of the dose, the code is visible and can be read out. The code can then be detected and read out by an optical sensor from outside the administration device.

The dispensing element can be, for example, a piston rod, a drive or dispensing sleeve or some other element of a dispensing device of the administration device. The code can be read out after a complete or at least planned, therapy-related pouring out movement of the pouring out element. In the case of a dose setting or dose correction movement, the code is therefore not visible and cannot be read out.

The data preferably include injection data such as information about the medicament in the reservoir or about the administration device. However, they can also include, for example, a manufacturer number, a lot number or an expiry date of the product in the reservoir. The identification code is preferably a code based on a standardized identification system, in particular the “Identification of Medicinal Products” (IDMP).

In a preferred embodiment, the dispensing element is a piston rod. In this case, the code is coupled to the piston rod in such a way that it can only be seen and read from outside the administration device after the dispensing movement, in particular a distal displacement of the piston rod. The administering device can, for example, have an opening in the housing or be made of at least partially transparent material so that the piston rod with the code can be read from the outside after the dispensing movement. In a preferred embodiment, the administration device is an autoinjector.

The invention further relates to an administration device for dispensing a dose of a product from a reservoir held in the administration device. The administration device comprises a distal contact surface which is designed to touch a surface of an injection site during an injection process and to transfer a stamp color onto the surface. By means of the stamp ink, an optical pattern can be displayed on the contact surface, so that when the stamp ink is transferred, a machine-readable image of the pattern is generated on the surface, the image representing coded injection data.

By transferring the stamp ink from the contact surface of the administration device to the surface at the injection site, a marking is generated in the form of a machine-readable image of the pattern. It is thus visible and can be checked on the basis of the represented injection data whether the user has made an injection.

If the user takes the generated image after completing the injection, for example with a user device such as a smartphone and electronically forwards the injection data to an external recipient, this recipient receives a confirmation that the user has performed the injection. The encoded injection data preferably include specific information on the injection, such as information about the medical product used in the reservoir, the administration device, an identification number and / or date and time information.

With known electronic additional modules, which can only detect the injection process directly on the administration device by means of sensors, injections can be simulated. The sensors in the additional electronic module or in the administration device itself can only detect whether the product has been poured out of the reservoir. In contrast, the sensors cannot detect whether the administering device has actually been placed on a surface and whether the dose was thus administered subcutaneously to the user.

In contrast, with the administration device according to the invention, the image with the coded injection data is only generated when the contact surface of the administration device is placed on the surface. If the product is poured out but the administration device is not placed on a surface of the injection site, no image is generated and there are no readable injection data. The injection data represented by the image are therefore more reliable than data which are recorded using known methods with sensors in or on the administration device.

The image generated also has the advantage that an injection site can still be seen by the user after the injection. In the case of certain medicinal substances, it is advantageous or even mandatory to inject later injections at a different injection site (injection site rotation). The created image makes it clear to the user at which point an injection has already been carried out.

The administering device preferably has sections on the contact surface which are partially or partially colored or provided with stamping ink, or the contact surface comprises sections which can be wetted with stamping ink during an injection process. These sections form an optical pattern. This is formed, for example, in that individual sections have a stamp color, while others have no stamp color. The contact surface can be a planar surface which has the stamp color in sections, or the pattern on the contact surface can be formed by elevations or depressions, for example only the elevations having the stamp color.

The contact surface is preferably located at a distal end or distal end region of the administration device. The contact surface is preferably located in a plane which is at right angles to the longitudinal axis of the administration device or to a dispensing direction. Accordingly, the contact surface can be arranged, for example, on a distal end surface or also on a distal surface of a protective sleeve. The contact surface can also be covered by a cap, a protective sleeve or a cover in an initial or initial state of the administration device and only released at the beginning or during the injection process so that it can contact the surface.

In an initial or initial state of the administering device, either the stamp color is already partially or in sections on the contact surface, so that an optical pattern is formed, or the stamp color is applied to the contact surface before the contact surface comes into contact with the surface. In this case, for example, the contact surface is pressed onto a stamp pad prior to contact with the surface, or the stamp ink is applied to the contact surface by means of a transfer device.

The contact surface is designed to touch the surface of the injection site during an injection process. This means that the contact surface can already touch the surface at the beginning, when the administration device is placed on the surface. In an alternative embodiment, however, the administration device can be designed in such a way that the contact surface only touches the surface during or even only at the end of the injection or after the injection. In this case, the contact surface is preferably located on an element that can be moved relative to the housing of the administration device (for example on a protective sleeve or stamp), which is moved towards the distal end of the administration device when the injection is completed so that the contact surface can touch the surface and the stamp ink is transferred to the surface.

In order to administer a dose of the product from the reservoir, an injection needle or an injection cannula of the administration device is inserted into the skin of the user. The place of this puncture is the injection site. When the administration device is used correctly, the surface therefore corresponds to a skin surface of the user.

The optical pattern represented by the stamp ink is located on the contact surface. The stamp ink can be transferred to the surface by the contact between the contact area and the surface. It goes without saying that the pattern on the contact surface is a mirror image of the transferred image on the surface or represents a negative. The image with the coded injection data is only created once the pattern has been transferred to the surface. In other words, the coded injection data can preferably only be read out when the inverse pattern of the contact surface or the image of the pattern on the surface has been generated. However, the transfer of the stamp ink can only take place when the contact area touches the surface. This is preferably only possible if the injection needle has been inserted into the surface (into the skin of the user). Misuse or a simulated injection can thus be effectively prevented, since the injection data cannot be read directly from the contact surface, but can only be read from the generated image.

The image can be read out by means of an optical sensor. The image can comprise one- or multi-dimensional black-and-white or colored elements which represent a one-dimensional or multi-dimensional code. This code represents encoded injection data. Coded means that the injection data cannot be read directly by a human. The injection data are therefore preferably not represented mainly by alphanumeric characters. Correspondingly, the injection data read out first have to be decoded using electronic means. Examples of a machine-readable image are a barcode, a one-dimensional barcode or a two-dimensional data matrix code.

In a preferred embodiment, the administration device is designed as an autoinjector which contains a prefilled syringe. Alternatively, the administration device can also be an injection pen that can be used once or several times.

In a preferred embodiment, the pattern is formed by elevations and depressions in the contact surface. The pattern is accordingly formed three-dimensionally in the contact area. The stamping ink is preferably located on the elevations or is transferred to them at the beginning of an injection, so that only the stamping ink is transferred from the areas of the elevations to the surface and the areas of the depressions do not transfer any color.

In a preferred embodiment, the stamp color is in an initial or initial state on the contact surface. The administration device is in an initial state if it has never been used and / or no dose of the product has yet been poured out of the reservoir.

So that the stamp ink is not inadvertently transferred to another location before the injection process, it is preferably covered by a cover element such as a protective cap or cover film. At the beginning of the injection process, the cover element is removed manually by hand or automatically by a movable element, so that the stamp ink can be transferred to the surface.

As an alternative to this, there is also the possibility that the stamp ink is only transferred to the contact surface at the beginning of the injection process, for example by manual or automatic at least partial soaking of the contact surface in a stamp pad.

In an advantageous embodiment, the administration device comprises a protective cap which, in the initial state, covers the stamp color. This prevents unintentional transfer of the stamp color from the contact surface to another element. The protective cap must be removed manually by the user before the injection process. Alternatively, there is also the possibility that at the beginning of the injection process, for example when the contact surface is placed on the surface, a release mechanism of the administration device is activated, which automatically pushes the protective cap away from the contact surface so that the contact surface is released and the stamping ink is applied to the surface is transferable.

In a preferred embodiment, the contact surface is arranged on a distal end surface or on a distal end surface of the housing. Included. This end face or end face touches or contacts the surface at the injection site when the delivery device is fully placed on the surface (the skin surface of the user). The injection needle or cannula can already be pierced into the skin, or it is displaced distally relative to the housing by a release mechanism and pierced into the skin only after it has been placed.

In an initial or initial state of the injector, the end face or end face is advantageously covered at least in the lateral direction by a protective cap, a sliding protective sleeve or a cover element so that the stamp color is not accidentally transferred to another element. Preferably, after a proximal displacement of the protective sleeve or of the cover element with the contact surface, the surface can be touched. When the administration device is placed on the surface of the injection site, in this embodiment the cover element is displaced proximally so that the contact surface can touch the surface and the image can thus be created on the surface.

In an alternative embodiment, the contact surface is located on an annular distal end face of a needle protection sleeve. The contact surface is preferably arranged at right angles to an injection direction. This enables a space-saving construction.

In this embodiment, when the administration device is placed on the surface, the distal end face of the needle protecting sleeve first touches the surface. In this case, on the one hand, the stamp color is preferably transferred and, on the other hand, the needle protection sleeve is moved back proximally relative to the housing, so that the needle is released and can be pierced into the surface.

In a further alternative, the administration device comprises a needle holder for holding an injection needle or injection cannula, the contact surface being a distal end surface of the needle holder. In this embodiment, the administration device is preferably an injection pen that can be used once or several times. The reservoir is designed in the form of a carpule which is held by a carpule holder. A distal area of the carpule holder is preferably designed as a needle holder.

In this embodiment with the needle holder, too, the administration device preferably comprises, in an initial or initial state, a removable protective cap which covers the contact surface with the stamp ink.

The coded injection data advantageously include information for identifying the administration device and / or the product in the reservoir. Examples of this are information on the type of administration device, name and designation of the product, expiry date of the product or a manufacturer or lot number. In addition, the injection data can include a user-specific code.

Instead of or in addition to the identification data, the data preferably include time and date information at the time of injection. As a result, an external recipient who receives the injection data can draw conclusions about the frequency and / or the time of administration. In particular, it can be checked whether a given therapy plan is being adhered to by the user. In addition, thanks to the time information, the injection dates can also be entered chronologically in a therapy diary.

These time and date information can be generated, for example, by an electronic circuit in the administration device, a time-specific pattern being applied to the contact surface by means of a stamp mechanism (specific coloring of areas on the contact surface). In an alternative embodiment, the time and date are set manually by the user before an injection process on a setting mechanism, as a result of which the pattern on the contact surface is adjusted.

The identification code is preferably a code according to a standardized identification system, in particular the "Identification of Medicinal Products" (IDMP)

The stamping ink is preferably a skin-compatible ink. This is preferably abrasion-resistant but can be washed off after a while. Markings with such ink are also known as "medical tattoos".

The invention further comprises a computer-implemented method for capturing a code at an injection site. The procedure consists of the following steps: Detecting and reading out, by a camera of a user device, a code generated from stamp color, which code represents encoded injection data and is located at the injection site; Decoding the encoded data; Capturing, by the camera, a surface at the injection site; Validating the captured surface as human skin; Transmission of the decoded data to a remote or external receiver.

The invention further comprises a computer program which comprises instructions which, when the program is executed by a computer, cause the computer to carry out the steps of the above computer-implemented method.

The code is captured and read out by the camera of the user device. The data read out can be processed further directly on the user device or, alternatively, they can be transmitted by the user device to a remote or external recipient for further processing. The further processing can include any decoding of the data, evaluation, analysis and / or preparation for a display.

Thus, the decoding and also the validation can take place directly on the user device. Alternatively, there is also the possibility that the data read out and the camera data of the captured surface are transmitted by the user device to a remote or external receiver, which decodes, validates the captured surface and, if necessary, also processes and displays the data.

The user device is, for example, a smartphone, a tablet computer, a smart watch, a notebook or some other portable computer which is not physically connected to the administration device.

The generated code is located at the injection site. This means that the code is in the vicinity of the puncture site generated by the injection needle, the code being arranged in such a way that it can be detected with the camera in a recording or by means of an image together with the injection site. If the puncture site is, for example, on a forearm of the user, the code is also arranged on the forearm so that it can be detected by the camera together with the puncture site.

The validation of the recorded surface preferably comprises a comparison of the recorded surface with reference data. This makes it possible to determine whether the recorded surface corresponds to a human skin. Such reference data can be, for example, image information or image data of the human skin.

By validating the detected surface, a simulated injection in which the dose was not injected subcutaneously into the user can be detected. In this case, the data can be identified and / and a message can be displayed to the user, for example via the user device.

If the validation is successful, the decoded data can include a confirmation that the user actually pierced the skin and that the injection was made subcutaneously. Incorrect manipulation or deliberate deception can thus be recognized. If the user places the administering device on a material outside the human body in order to generate an image with injection data on the material with the contact surface of the administering device, the detected surface does not correspond to the reference data and it can be recognized that the injection was not in a human body is done.

The external recipient is preferably a data cloud, a server or a computer, for example a health facility, an insurance company or a drug manufacturer.

In a preferred embodiment, the data are specifically identified after the validation before they are transmitted to an external recipient if the surface detected does not correspond to a human skin. The processing of improperly generated injection data can thus be effectively avoided. Furthermore, only actually administered drug doses can be recorded in a therapy diary, a therapist only receives data on actually administered doses and / or the insurance company can reliably calculate the remuneration based on the actually administered doses (outcome based payment). The resilience of the data is thus increased.

CHARACTERS

In connection with the attached figures, preferred embodiments of the invention are described below. These are intended to show the basic possibilities of the invention and are in no way intended to be interpreted as restrictive. 1 shows an injection pen with a code area according to the invention on the carpule holder; FIG. 2 shows a second embodiment according to the invention, in which the code area is arranged on the housing of the injection pen; 3 shows a third embodiment according to the invention, in which the code area is arranged on a piston rod element in an autoinjector; 4 shows, enlarged, the code area with the plug of the carpule; 5 shows a schematic representation of the data transmission; 6a shows an auto-injector in an initial state in which the code is arranged on the piston rod; FIG. 6b shows the autoinjector from FIG. 6a in a discharged state; 7a shows an auto-injector in an initial state in which the code is arranged on a distal end surface; FIG. 7b shows the autoinjector from FIG. 7a in a discharged state; FIG. 8 shows, enlarged, a generated image which represents coded injection data.

FIGURE DESCRIPTION

FIG. 1 shows an administration device according to the invention in the form of a disposable injection pen 1 in a side view. The single-sided, distal end of the injection pen 1 is on the left and the proximal end on the right of the illustration. For the sake of simplicity, the injection pen 1 is shown without an injection needle and without a protective cap. The injection pen 1 comprises a housing 2 in which a dosing and dispensing mechanism, not described in detail and not shown, is accommodated, a carpule holder 3 and a carpule 11 held in the carpule holder 3 with a liquid medical product such as insulin. Inside the carpule 11 there is a displaceable stopper 6 as a dispensing element. This can be displaced in the distal direction within the carpule 11 for pouring out the product. For this purpose, the dosing and dispensing mechanism comprises a piston rod 7 which acts on the stopper 6 in the distal direction in order to move it.

The carpule holder 3 is made of transparent plastic and the carpule 11 is made of glass, so that the stopper 6 can be seen and optically detected from outside the injection pen 1. In the embodiment shown, the carpule holder 3 also has an elongated recess through which part of an outer surface of the carpule 11 can be seen from the outside. On the outside of the cylindrical carpule holder 3, an elongated, rectangular code area 4 is placed, which is designed as a two-dimensional code and extends along a longitudinal axis of the injection pen 1, as can be seen in FIG. The length of the code area 4 is dimensioned such that it covers the entire possible displacement path of the stopper 6.

The code area 4 is placed in relation to the recess in such a way that the plug 6 is located at least halfway behind the code area 4. Since the carpule holder 3 is transparent, there is a non-readable area 42 of the code area, which lies radially in front of the stopper 6, also visible in FIG. 4. The remaining area of the code area 4 in the longitudinal direction in front of and behind the stopper 6 has a stronger contrast, because there is no element in this area. These areas are readable areas 41 because they are visible from outside the injection pen 1 and can be read out by means of an optical sensor.

The code of the code area 4 changes gradually in the delivery direction (in the longitudinal direction of the injection pen) and thereby forms a length scale. In concrete terms, viewed in the direction of delivery, the code is composed of individual one-dimensional barcodes 9 which extend at right angles to the direction of delivery, shown in FIG. 4. The individual barcodes 9 are unambiguous. This means that they each differ from one another by at least one code element. The data from the individual barcodes 9 thus differed by at least one bit. For every possible position of the stopper 6 relative to the carpule 11 (and relative to the housing 2) there is a barcode 9 in the transverse direction, which can be read out by an external device depending on the stopper position. In the embodiment shown, the code represents a simple binary code. However, in other versions it can also be designed, for example, as a Gray code.

The size of the code elements in the direction of delivery or the width of the one-dimensional barcode 9 is selected so that this dimension corresponds at most to a distance that the stopper 6 covers in the distal direction in order to deliver the smallest dose that can be poured out. In the case of an injection pen 1 with insulin, this means that each insulin unit dispensed can be recorded individually, since the code has at least as many one-dimensional barcodes 9 as there are insulin units that can be dispensed.

The code area furthermore has several markers or identification points on the edge, which are read out together with the position information. As a result, the software application, which processes the data that has been read out, can determine the location, size and position of the code area so that the position data can be reliably recorded.

In addition to the code area 4, the housing 2 has an identification code 8 in the form of a QR code in a distal area. This represents, for example, information about the type of injector and the medical product it contains, as well as its expiration date. In addition, the identification code 8 can comprise encoded instructions. This means that after the data has been recorded and decoded from the identification code (NFC standard), a software application on a smartphone 30 of the user receives instructions for automatically calling up a specific website or for automatically executing a further application. For example, an electronic diary can be started directly on the smartphone 30.

The reading out of the code area 4 and the detection of the position of the stopper 6 will now be explained in detail in connection with FIG. To detect a dispensing state, the user activates a barcode application or the camera of the smartphone 30 on his smartphone 30 and uses the camera to record the code area 4 on the carpule holder 3 and at the same time the identification code 8 on the housing 2 of the injection pen 1.

In FIG. 4 it can be seen that the non-readable area 42 of the code area 4 lies in the radial direction in front of the stopper 6. The remaining readable areas 41 of the code area 4 are located in the longitudinal direction distal and proximal of the stopper 6. They are clearly visible and can be read out optically.

The application called up on the smartphone 30 recognizes the stopper 6 and in particular a distal end edge 5 of the stopper 6 based on the recorded camera data. The application also detects the barcode 9 currently adjacent to the distal end edge 5 the stopper 6 is in a different position relative to the code area 4, since the piston rod 7 of the dosing and dispensing mechanism moves the stopper 6 in the distal direction (to the left in FIG. 4). Accordingly, after each pouring out, when the code area 4 is detected by the application, another barcode 9 adjoining the terminating edge 5 is detected. Together with the barcode 9, the application also records the identification code 8 on the housing 2.

The encoded data captured from the code area 4 (barcode 9) and from the identification code 8 are decoded by means of the application on the smartphone 30. In the exemplary embodiment shown, each one-dimensional barcode 9 of the code area 4 represents binary data which represent a specific position specification. The capacity of the carpule 11 and the size of a dispensable unit are stored in the application. As a result, the application can use the decoded data to calculate the amount of medicament that has already been poured out of the carpule 11 and / or the amount still remaining in the carpule 11.

Alternatively, the information on the capacity of the carpule 11 can also be stored in the identification code 8 on the housing 2, which is read in together with the code area 4. In both cases, the application decodes the data and displays it to the user together with the calculated amount distributed.

In FIG. 2 a second and in FIG. 3 a third embodiment of the administration device according to the invention is shown.

In contrast to the first embodiment, in the embodiment according to FIG. 2, the code surface 14 is not arranged on the carpule holder 13. In this second embodiment, the housing 12 of the injection pen 10 has a viewing window 19 in a distal area, through which the piston rod 17 can be seen from outside the injection pen 10. Furthermore, at least one area of a code surface 14 can be seen through the viewing window 19, which is attached to the inside of the housing 12 in a fixed manner to the housing. The piston rod 17 comprises a pointer 16 fixed immovably on the piston rod 17. This pointer partially covers the code area 14. As a result, there is an area of the code area 14 that can be read from outside the injection pen 10 and one that is covered by the pointer 16 and cannot be read from the outside.

When pouring out the piston rod 17 moves in the distal direction. As a result, the pointer 16 is also moved distally. The application of the smartphone 30 detects a distal terminating edge 15 of the pointer 16 and reads accordingly the code section which is distal to this terminating edge 15. Alternatively, the area of the code area 14 which is proximal to the pointer 16 can also be read out. The determination of the position of the piston rod 17 relative to the housing 12 and thus the determination of the amount of medicament that has been poured out takes place as described above in connection with the embodiment according to FIG.

In contrast to the first embodiment, the injection pen shown in FIG. 2 does not have an identification code. In order to be able to assign the position data to a specific drug and / or injection pen, the code area 14 itself comprises identification data.

In FIG. 3, a further embodiment according to the invention is shown. In this case, the administration device is an autoinjector 20 which contains a prefilled syringe (not shown). By operating a dispensing mechanism not described further here, the contents of the syringe are dispensed in a spring-driven manner. A code area 24 is fixed to the housing inside the autoinjector 20. The code area 24 and a pointer 26 immovably connected to a piston rod can be seen through a viewing window 29 in the housing 22 from outside the autoinjector 20. Before an injection or in an initial state, the pointer 26 covers a proximal area of the code area 24. After the injection, when the pointer 26 has moved together with the piston rod in the distal direction, the pointer 26 covers a distal area of the code area 24. Since the Code area 24 has code elements that can be changed in the longitudinal direction (here black and white fields), the user can, as described above in connection with the first and second embodiments, capture the readable area of the code area 24 with his smartphone 30. Specifically, this means that if a white field is visible and can be read out, the injection has not yet taken place. Correspondingly, the injection has taken place when the pointer 26 covers the white field and thus only a black field is visible and can be read out. The application on the smartphone 30 recognizes the pointer 26 and either the black or the white field next to the pointer 26. After the evaluation, the application shows the user whether the autoinjector 20 is in an initial state or in a discharged state. As mentioned above, the application also transmits this information to an external recipient.

The autoinjector 20 also includes an RFID transponder 28, which is read out by the smartphone 30 together with the code area 24. Depending on the type of smartphone 30, it may be necessary for the read-out not to take place simultaneously but in immediate succession. The RFID transponder 28 includes specific identification data about the type of the autoinjector 20 and information about the medical product in the autoinjector 20. The application processes these identification data together with the data read out from the code area 24.

FIG. 5 schematically shows the data flow when a user records the coded data on the injection pen 1 with his smartphone 30 and these are then forwarded to a server 31 and to a computer 32 belonging to an external specialist. The transmission of the data is shown in FIG. 5 by arrows with solid lines, while the interaction with the user is shown by dashed arrow lines. In FIG. 5, the administration device is shown in the form of an injection pen 1. As mentioned above, the code area according to the invention can just as well be arranged on an autoinjector 20 or some other administration device.

Before and / or after an administration, the user points the camera of his smartphone 30 at the code area 4. The application records the encoded data of the code area 4 and any identification code 8 that is present and decodes all of the data. The decoding takes place either continuously during the reading in or after the reading in after the camera has recorded all the information on the code area 4. As mentioned above, the application shows the user on the smartphone 30 the calculated amount of the dispensed dose and also the identified type of the injection pen 1 and the data on the medical product.

After the user has captured a confirmation, the position data, the calculated dose delivered, the time of administration and information about the injection pen and the medical product are sent to a data cloud or an external server via an Internet connection.

In a preferred embodiment, the identification code 8 comprises instructions for automatically executing an application on the smartphone 30. If, at the beginning of the reading process, the user points the camera of the smartphone 30 at the injection pen 1 and the application recognizes the identification code 8 based on the camera data and reads out the data, a web browser is automatically started on the smartphone 30, which displays a camera preview. This makes it easier to position the camera and to capture the code area 4 on the injection pen 1. In addition, data that have already been read from the identification code 8 can be automatically processed further.

In the embodiment according to FIG. 5, a computer 32 belonging to an external specialist such as, for example, an attending physician is also shown. In this embodiment, the server 31 belongs to a health facility such as a hospital or care center. The specialist can use the computer 32 to access the data transmitted to the server 31 on the one hand and to communicate directly with the application on the smartphone 30 of the user via the Internet on the other hand. In this way, the specialist can provide the user with information or instructions directly. The communication between the computer 32 and the user's smartphone 30 is particularly important if the specialist has determined on the basis of the data on the server 31 that the user is not administering the doses according to the therapy plan, is administering a dose that is too large or too small, or that the wrong medical product has been administered.

In a further embodiment, the data can also only be transmitted to the data cloud or the server and evaluated there. For example, an application on the server can automatically credit the user with points or discounts if the user complies with certain conditions, such as regularly collecting and sending data or administering the correct medical product at the correct time in accordance with a therapy plan.

In a further embodiment, the data can be transmitted to a server of a drug manufacturer, which uses the recorded administration data for research purposes or for the further development of medical products.

Figures 6a and 6b show a further embodiment. FIG. 6a shows the administration device in the form of an autoinjector 100 in an initial or initial state. This comprises a housing 110, a needle protection sleeve 130 and a dispensing mechanism with a drive spring, which is located inside the housing 110 and is not explained further here and is not shown. In the housing 110 there is also a reservoir in the form of a prefilled syringe, which is likewise not visible. The needle protection sleeve 130 is located at a distal end (in FIG. 6 a at the left end) of the autoinjector 100 and is displaceable relative to the housing 110. An opening with a viewing window 120 is also formed in the housing 110.

To pour out the dose with the autoinjector 100, the latter is placed with the distal end of the needle protection sleeve 130 on an injection site and pressed onto the injection site in the direction of the longitudinal axis of the autoinjector 100. As a result, the needle protection sleeve 130 moves relative to the housing 110 from the position shown in FIG. 6a into a proximal position, shown in FIG. 6b. This displacement of the needle guard 130 activates the dispensing mechanism. The pretensioned drive spring moves a dispensing element in the form of a piston rod 150 in the distal direction. The piston rod 150 acts on a stopper in the syringe and also displaces it in the distal direction. As a result, the drug is poured out of the reservoir via an injection needle 160 from the auto-injector.

FIG. 6b shows the autoinjector from FIG. 6a in a discharged state in which the entire dose of the syringe has been administered. As can be seen in FIG. 6b, the needle protecting sleeve 130 is in this discharged state in a proximal position, as a result of which the injection needle 160 is released and is located in the skin of the user (not shown). The piston rod 150 can be seen through the viewing window 120, since it has been displaced distally by the drive spring after a complete dispensing movement. The piston rod 150 comprises a code 140 immovably connected to the piston rod 150 code area or code 140. This code 140 is only visible when the piston rod 150 has been displaced completely distally by the dispensing movement. The code 140 can therefore only be read from outside the autoinjector 100 when the dose has been completely poured out.

The code 140 is designed as a two-dimensional data matrix code which represents coded data. These include a unique identification number, as well as information about the medicinal substance in the reservoir and its expiration date.

After completion of the administration, when the code 140 can be seen on the piston rod 150, the user can capture the code 140 with the camera of his smartphone. The data represented by code 140 is decoded and processed further, displayed and / or forwarded to an external recipient in an application in the smartphone. Since the code 140 can only be seen after it has been poured out, it is ensured that the data are only sent to the recipient when the distribution with the autoinjector 100 has actually taken place. The processing, analysis and forwarding of the data can be carried out as explained above in connection with FIG.

A further embodiment is shown in FIGS. 7a, 7b and 8. FIG. 7a shows an autoinjector 200 in an initial or initial state. A needle protection sleeve 230 arranged at the distal end of the autoinjector is in this initial state in a distal position in which the needle protection sleeve 230 covers an injection needle 260.

FIG. 7b shows the autoinjector from FIG. 7a in a discharged state. In this the needle protection sleeve 230 is in a proximal position. The injection needle 260 is therefore no longer protected by the needle protection sleeve 230 and is located in the user's skin (not shown).

In this embodiment, in the proximal position of the needle protection sleeve 230, a distal end surface or contact surface 240 of the autoinjector 200 is released from the needle protection sleeve 230 and is accessible from the outside. As a result, this contact surface 240 can touch a skin surface of the user when the distal end of the autoinjector 200 is placed on an injection site for an injection. The contact surface 240 is at right angles to the longitudinal axis of the autoinjector 200. In addition, the contact surface 240 has several elevations and several depressions (not shown) which form an optical pattern 250. The elevations are rectangular and provided with a skin-friendly stamp color. In the initial state, the contact surface 240 is protected by the needle protection sleeve 230, so that the stamp color cannot inadvertently be transferred from the contact surface 240 to another element.

To pour out the dose with the autoinjector 200, the latter is placed with the distal end of the needle protection sleeve 230 on an injection site and pressed onto the injection site in the direction of the longitudinal axis of the autoinjector 200. As a result, the needle protection sleeve 230 is displaced relative to the housing 110 from the position shown in FIG. 7a into the proximal position, shown in FIG. 7b. This displacement of the needle protection sleeve 230 activates a dispensing mechanism and the dose is dispensed through the injection needle 260. The user presses the autoinjector 200 onto the surface of the skin while dispensing. As a result, the contact surface 240 is also pressed onto the skin surface. In this case, the stamping ink is transferred from the areas of the elevations of the contact area 240 to the skin surface, while no color is transferred in the areas where the depressions of the contact area 240 are located. This creates an image of the pattern 250 of the contact area 240 on the skin surface. The image forms a two-dimensional code in the form of a data matrix code 270, which represents coded injection data.

The data matrix code 270 generated by the pattern 250 of the contact area 240 on the skin surface is shown in FIG. In comparison to the scale of FIG. 7b, the code 270 is shown enlarged in FIG. After completion of the injection, when the stamp color has been transferred from the contact area 240 to the skin surface and the auto-injector 200 has been removed from the injection site, the user can capture and read out the DataMatrix code 270 with the camera of his smartphone. An application on the smartphone decodes the injection data from code 270. The injection data include a unique identification number, information on the medical substance and its expiration date.

Together with the code 270, the camera also records an area of the surface of the injection site. These camera data are used to validate the skin surface. This means that the application compares the captured surface with reference image data of a human skin in order to determine whether the captured surface is really a human skin. This means that the application checks whether the user really made the injection subcutaneously.

If the validation was successful and the detected surface was identified as human skin by the application, the application sends the decoded injection data to a data cloud or an external server, for example a health facility or an insurance company. The processing, analysis and forwarding of the data can be carried out as explained above in connection with FIG.

Since the contact surface 240 of the autoinjector 200 can only contact the skin surface when the autoinjector 200 is pressed onto the injection site, the needle guard 230 is in its proximal position and the injection needle 260 has thus pierced the user's skin, the image can can also only be generated with the data matrix code 270 when an injection has actually taken place. The (negative) optical pattern 250 on the contact surface 240 cannot be read out electronically or at least clearly distinguishable from the image. Only the stamped image results in a code 270 with readable data which confirm an injection.

As a result, the external recipient, who receives the injection data from the application, receives a confirmation that the injection actually took place. In addition, since the injection data are only transmitted if the recorded surface has really been identified as human skin, incorrect manipulations or a simulated injection in which the dose was not injected into the user can be ruled out. The injection data are therefore reliable.

REFERENCE LIST

1, 10 injection pen 2, 12, 22 housing 3, 13 carpule holder 4, 14, 24 code area 5, 15 end edge 6 stopper 7, 17 piston rod 8, 28 identification code 9 one-dimensional barcode 11 carpule 16, 26 pointer 18 area 19, 29 Viewing window 20 Autoinjector 28 Transponder 30 Smartphone 31 Server 32 Computer specialist 36 Area 41 Readable area 42 Non-readable area 100,200 Autoinjector 110,210 Housing 120 Window 130,230 Needle protection sleeve 140 Code 150 Piston rod 160, 260 Injection needle 240 Contact surface 250 Pattern 270 DataMatrix code

Claims (15)

1. An administration device (1) for dispensing a dose of a product from a reservoir (11) held in the administration device (1), the administration device (1) comprising a housing (2); a dispensing element (6), movable relative to the housing (2) in a dispensing direction, for dispensing the product; a machine-readable optical code area (4) which represents distinguishable data along the discharge direction, the data being coded, characterized in that the code area (4) is fixed to the housing, and that before and / or after a dispensing movement of the dispensing element (6), a surface (36) of the dispensing element (6) at least partially overlaps the code surface (4) so that the code surface (4) has an overlapped area (42) which cannot be read from outside the administration device (1) and has a non-overlapping area (41) which can be read out, the readable area (41) being variable during the dispensing movement, and wherein the data include position information, so that a current position of the shaking element (6) relative to the housing (2) can be determined by at least partial reading of the readable area (41). 2. Administration device (1) according to claim 1, characterized in that the code area (4) represents a length scale aligned in the discharge direction. 3. administering device (1) according to claim 2, characterized in that a graduation of the length scale is designed so that a distance between two successive graduation markings is equal to or smaller than a distance to be covered by the dispensing element to dispense the smallest dispensing dose. 4. administering device (1) according to one of claims 1 to 3, characterized in that the code area (4) contains a two-dimensional code, in particular that the code area is curved and contains a two-dimensional code. 5. administering device (1) according to claim 4, characterized in that the code area (4) represents a binary code. 6. administering device (1) according to one of claims 1 to 5, characterized in that the code surface (4) is arranged on a carpule holder (3). 7. administering device (1) according to claim 6, characterized in that the carpule holder (3) comprises an interior space and that the code surface (4) is arranged on an inner wall of the interior space. 8. administering device (1) according to one of claims 1 to 6, characterized by an identification code (8) which can be read out together with the readable area (41) and comprises encoded data to identify the administering device (1) and / or the product. 9. administering device (1) according to claim 8, characterized in that the data additionally comprise instructions for a computer program for the automatic execution of the computer program. 10. administering device (1) according to one of claims 1 to 9, characterized in that the dispensing element (6) is a stopper within the reservoir (11). 11. administering device (1) according to one of claims 1 to 9, characterized in that the dispensing element (6) is a piston rod (7) or a flange. 12. A computer-implementable method for determining a position of a shaking element (6) relative to a housing (2) of an administration device (1) according to one of claims 1 to 11, comprising the steps: - Optical reading of the readable area (41) of the code area (4) by means of a camera of a user device (30); - Decoding and evaluating the coded data of the read area (41); - Determining a position of the shaking element (6) relative to the housing (2) based on position information from the evaluated data. 13. The method according to claim 12, characterized in that the determination of the position of the shaking element (6) takes place with the user device (30). 14. The method according to claim 12, characterized in that the data are transmitted from the user device (30) to an external receiver (31), the determination of the position of the shaking element (6) at the external receiver (31). 15. A computer program, comprising instructions which, when the program is executed by a computer, cause the computer to carry out the steps of the method according to one of claims 12 to 14.