Patent Application
20240157062
The present invention relates to the field of medical injection systems, such as smart injection systems, which can transmit data from a drug delivery device for medication to other devices and which can optionally be easily adapted to the needs of various medical indications if required.
More and more diseases and illnesses are becoming treatable. Increasingly expensive medications and treatments are finding their way into therapy. Therefore, controlling costs while ensuring patient safety and data protection is becoming increasingly important. On the one hand, attempts are being made to enable home therapies even for more complex therapies, which can reduce healthcare costs. On the other hand, for example in the case of more expensive therapies, it should be possible to ensure that medications are used correctly by patients, even in the case of home therapy, and that patient compliance is ensured.
Injection systems are known from the prior art in which drug delivery devices send information about the use of the drug delivery devices to a mobile device via Bluetooth, and the mobile device forwards at least some of the information to one or more remote servers. Since this information may comprise sensitive patient information, this information may be transmitted securely to protect it from unauthorized access. The connection between the mobile device and the drug delivery device may thus be protected, as well as the connection between the mobile device and remote server computers. In addition, the information may also be stored securely on the respective devices and computers.
An encrypted Bluetooth connection is typically used to connect the mobile device and the drug delivery device. For this purpose, the mobile device and the drug delivery device may go through a coupling process, which, among other things, enables unique identification and assignment among the communication partners. In the Bluetooth communication protocol, this coupling is called “pairing”. To further secure the connection, further encryption can be established at the application level between the mobile device and the drug delivery device. This multi-level security may often require a coupling, pairing and key exchange process initiated by a user. For simpler injection devices such as autoinjectors, securing the connection between the injection device and the mobile device can thereby take more time than the actual injection process. For patients, multi-level security of the connection is also associated with the risk of incorrect handling, for example in the case of visual impairment. There is therefore a need for easy-to-use and yet secure information transmission for injection devices which, for example, are only used for one injection and are disposed of after use.
Manufacturers of injection apparatuses, medication manufacturers, health insurers and people requiring care may also need to have injection apparatuses to hand that are as safe and effective as possible. Accordingly, it would be desirable to have an injection apparatus which has a consistent, proven, safe and predetermined technical design having a consistent housing, where the outer shape, feel, surface topography and ergonomics of the injection apparatus can be tailored even during production of the device using additional attachments that are firmly and permanently connected to the housing, which allows the needs of the medical indication to be taken into account in a simple and cost-effective manner.
It is an object of the invention to provide alternative injection systems which allow for simplified and secure transmission of injection data from an injection device to a remote server.
The object is achieved by a method and a system according to the implementation of disclosure.
In one embodiment of the invention, the invention includes a system for the secure transmission of medical information. The information is first transmitted from a drug delivery device to a mobile device and then from the mobile device to a remote server or computer.
The drug delivery device can be a patch injector, an autoinjector, an injection pen or an infusion pump. Further possible drug delivery devices are devices for inhaling substances via the respiratory tract, both for medical purposes and recreational use. According to the invention, drug delivery devices can also be constructed modularly from components which can or cannot be detached from one another. Typical modules are a reservoir unit having the reservoir for disposable use, a communication module and a reusable drive unit having the drive. A patch injector and an autoinjector are used as examples below for the description of the invention.
Such an autoinjector includes a device for administering fluid medication, as is known to a person skilled in the art from commercially available autoinjectors. Furthermore, the autoinjector includes an electronic controller. The controller can be connected to sensors which can also be provided in the autoinjector and can receive and process the measurement signals from the sensors. Furthermore, the controller is connected to a memory provided in the autoinjector, in which memory the controller can store data. A Bluetooth unit is arranged in or on the autoinjector, which Bluetooth unit is connected to the controller and via which data can be sent and received wirelessly. The Bluetooth unit can send and receive data in a transmission or broadcast mode in the form of advertising packets described above, i.e., without an identifier, address or other previously known identification for one or more receiving devices. In one embodiment, the Bluetooth unit functions exclusively as a beacon in transmission or broadcast mode. In an autoinjector equipped in this way, drug delivery can be monitored via the sensors. The controller can receive the sensor signals, store them and/or distribute them wirelessly via the Bluetooth unit.
In an alternative and optional form of a drug delivery device, the drug delivery device also includes, in addition to the elements obvious to a person skilled in the art, a plurality of housing-like shells, which may be attached to the outside of the housing of the drug delivery device. Drug delivery devices, such as autoinjectors, having the housing-like shells mentioned are also known from the prior art, such as in WO 2016179713 A1. What is special about this form is that at least some of the electronic elements described above for the autoinjector are arranged on the housing-like shells. The housing-like shells enable the external appearance of the drug delivery device to be adapted in terms of shape, material, color, ergonomics and/or feel to the requirements of the medical indication.
According to the invention, the system includes a mobile device. This can be a smartphone, a PDA, a tablet, a notebook or a similarly suitable device. According to the invention, the mobile device also contains a Bluetooth unit and a network unit for communication with remote devices. This can be an Ethernet unit, i.e., a wired network unit, a wireless network unit for a WLAN or similar system, a mobile communication unit or even a cell phone unit of any generation. Both Bluetooth and network are common functionalities in the device classes mentioned, are widespread and well known to a person skilled in the art.
According to the invention, the system includes at least one further remote computer or server. The at least one computer does not necessarily have to be a real computer, but can also mean one or more cloud instances, i.e., virtual computers or containers. The at least one computer or server computer includes at least one, possibly virtual, processor, a memory and a connection to a network. These components are common components in virtual and real servers and do not require any further explanation for understanding the invention.
The autoinjector, as a non-limiting example of an injection or infusion device according to the invention, has, as mentioned, a memory in which the controller can store data. Furthermore, at least one cryptographic key is stored in this memory, with which the controller can encrypt or certify data if required and can either store them in encrypted form in the memory or can distribute them in encrypted form via the Bluetooth unit of the autoinjector. An identifier for the autoinjector is then also stored in the memory. In a drug delivery device of modular design, the memory can also be constructed of several parts and distributed across the various modules. The key can be stored in a memory in a reservoir unit in order to ensure assignment to the medication.
The controller of the autoinjector can now encrypt drug delivery data which, for example, have been recorded and stored by means of the sensors, and, at least together with the identifier for the autoinjector, distribute them as an advertising packet via a Bluetooth unit in transmission or broadcast mode, for example as a sequence of several packets in a row. The identifier for the autoinjector is unique and is ideally only allocated once. In some embodiments, the drug delivery data may also comprise an absolute or relative time and/or date stamp. Furthermore, the drug delivery data may contain temperatures, sensor data, time measurements, states or activities.
The mobile device can receive the transmission in the form of the advertising packet via its own Bluetooth unit. For example, a corresponding app is installed on the mobile device which receives the data. However, the app does not have a key that would enable decryption of the encrypted data. On the other hand, it recognizes the identifier for the autoinjector and, if the autoinjector sends several packets, can classify these correctly. The app can then forward the at least one advertising packet received via the network unit of the mobile device to a computer or server known to the app.
The remote computer or server computer, hereinafter referred to as the server, can receive the transmission forwarded by the mobile device via its network connection. The device identifier can be read on the server. In one embodiment, a database in which the identifiers of the devices are stored is stored on the server. This database also contains a matching key for each identifier, with which key the encrypted data on the server can be decrypted. In an alternative embodiment, the server can have access to a further server on which the database is stored.
The decrypted data can then be used to analyze the drug delivery data, or, for example, to check when the autoinjector was used or whether a storage temperature was exceeded.
In one embodiment of the invention, the key in the drug delivery device for encrypting the data and the key on the remote computer or server form an asymmetric key pair. This corresponds to the common asymmetric key pairs of public and private keys, as are known to a person skilled in the art from the Internet. This has the advantage that data which have been encrypted with the key on the drug delivery device can only be decrypted with the key on the server. Even if a potential attacker could extract a key from the drug delivery device, they would not be able to access already encrypted data. Alternatively, the key pair can also be symmetrical, which also works when accepting the aforementioned disadvantage.
Since the mobile device does not store any of the keys, it does not have access to the actual drug delivery data either. If desired, decrypted data to be provided to a patient could be processed by the server and sent back to the app. The data can be evaluated and prepared on the server beforehand so that they may be provided in an easy-to-understand manner on the app.
In an embodiment, no Bluetooth pairing takes place between the drug delivery device and the mobile device before, during or after data transmission. In a further development, it is desirable that the Bluetooth unit of the drug delivery device is not capable of pairing at all, but is electronically reduced to the essentials, namely the ability to send or receive advertising packets.
In yet another development, the reception possibility is also omitted. This reduction to the essentials saves components and reduces potential sources of error.
In a further embodiment according to the invention, the drug delivery device according to the invention is of modularly design. For example, the drug delivery device can be formed from two modules, which can be detachably connected to one another. One module can be an injection or infusion module and the other can be a communication module. The communication module may contain electronic sensors, a controller, at least one processor, at least one memory component and a Bluetooth unit. The injection or infusion module could be designed as a classic injection pen, as an autoinjector or as a patch device without any electronics. This would, for example, allow the injection or infusion module to be designed as a disposable module and the communication module to be designed as a reusable module for repeated use. The modules described could each be integrated as components in a drug delivery device, or could be coupled to a drug delivery device as an additional module and could be detached therefrom again.
In a further embodiment according to the invention, after receiving an advertising packet from a drug delivery device, the mobile device also sends an advertising packet as a confirmation of receipt via the Bluetooth unit. In some embodiments, this confirmation of receipt is only sent when the mobile device has, in turn, received feedback from the server that the advertising packet that originally came from the drug delivery device has arrived at the server. Receipt of the packet is confirmed in the confirmation of receipt to the drug delivery device. The confirmation contains at least the identifier for the drug delivery device that sent the packet to be confirmed. Typically, a unique identifier for the mobile device is attached. As part of the packet length, other parameters such as a packet number can also be transmitted. The drug delivery device can receive and analyze or evaluate the confirmation of receipt.
The mobile device can receive advertising packets from a plurality of drug delivery devices and also confirm them. According to the invention, a drug delivery device can also receive advertising packets both from a mobile device and from a second drug delivery device.
If several drug delivery devices are now close to one another and can receive advertising packets from one another and confirmations of receipt from at least one mobile device, the drug delivery devices may use the additional information contained in the advertising packet or obtained therefrom upon receipt.
For example, a drug delivery device that receives such additional information can, the next time drug delivery data are transmitted, supplement (and encrypt) the drug delivery data with the information that additional drug delivery devices have been discovered in the vicinity. At most, the added information can include the identifier for the additional drug delivery device(s). Proximity, or the recognition of presence, can be meant qualitatively or quantitatively. Qualitatively means that a mobile device receives a signal from a drug delivery device. Quantitatively means that the mobile device can also estimate a measure of proximity. This can be done, for example, via the RSSI function, where RSSI means Received Signal Strength Indication (see the Bluetooth Core Specification, publicly available from Bluetooth SIG Inc., Kirkland, WA 98033, U.S.A., for example Version 5.2 dated 31 Dec. 2019).
If the server then receives such information, it can use the presence of additional evaluations. If the server also knows the other drug delivery devices (from the database), in one embodiment, the transmission reliability of the drug delivery devices can be recognized. Alternatively or additionally, a check can be made as to whether all of the recognized drug delivery devices, or the medications contained therein, are compatible with one another. If they are not, the server can send a warning to the app. In a further alternative, the server can also send recommendations to the app, for example recommending a specific order in which the various medications should be administered.
In further embodiments of the invention, a plurality of mobile devices may simultaneously receive information from a drug delivery device. In these embodiments, the Bluetooth units of the mobile devices may have implemented the RSSI (Received Signal Strength Indication) function (see the Bluetooth Core Specification, reference given above). This makes it possible for the mobile device to estimate the receiving distance, i.e., the distance between the transmitter and receiver at the time of data transmission, between the drug delivery device and itself. In this embodiment, the mobile device can attach the information extracted from the RSSI in this way to the advertising packet to be forwarded. Accordingly, identical advertising packets that were forwarded to the server via different mobile devices can be received on the server. For example, the server can then decide which of the identical advertising packets should be further processed. The information extracted from the RSSI function can help. For example, the server may decide that the advertising packet from a set of identical advertising packets, for which advertising packet the RSSI function indicates the smallest receiving distance between the mobile device and the drug delivery device, will be retained. The remaining advertising packets from the set of identical advertising packets can then be discarded, for example. Alternatively, all packets can also be used together for further evaluations. For example, it can be examined how many mobile devices are within the transmission range of a single drug delivery device which receive and forward the advertising packets. In this way, local clusters of patients being treated for the same disease may be identified.
Exemplary embodiments of the invention are described below in connection with the appended figures. These embodiments are intended to show basic possibilities of the invention and are in no way to be interpreted as limiting.
The term “product”, “medication” or “medical substance” in the present context includes any flowable or fluid medical formulation which is suitable for controlled administration by means of a cannula or hollow needle in subcutaneous or intramuscular tissue, for example a liquid, a solution, a gel or a fine suspension containing one or more active medical ingredients. A medicament can thus be a composition with a single active ingredient or a premixed or co-formulated composition with a plurality of active ingredients from a single container. The term includes drugs, such as peptides (e.g., insulins, insulin-containing medicaments, GLP 1-containing preparations as well as derived or analogous preparations), proteins and hormones, biologically obtained or active ingredients, active ingredients based on hormones or genes, nutrient formulations, enzymes, and other substances both 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 base substances, excipients, and carrier substances.
In the present description, the terms “injection system”, “injection device”, “injection apparatus” or “injector” are understood to mean an apparatus in which the injection needle is removed from the tissue after a controlled amount of the medical substance has been dispensed. In contrast to an infusion system, the injection needle in an injection system or in an injector thus does not remain in the tissue for a longer period of several hours. In addition to the actual injection device, an injection system may comprise one or more additional injection devices. Bluetooth is well known as a wireless technology. Bluetooth beacons are a little less well known. A beacon refers to a transmitter or receiver which is based on Bluetooth Low Energy BLE or Bluetooth Smart Technology BST. Basically, this is a wireless technology that can be understood as a development of Bluetooth. As with any wireless technology, at least one transmitter and at least one receiver are first required. The transmitters are referred to here as “beacons”. Their range is around ten meters, depending on the level of development and the manufacturer. Far less energy is used to transmit data between devices using BLE than with older versions of Bluetooth, which, for example, results in lower battery consumption for the transmitter. The costs of the transfer also remain low. Large amounts of data are not suitable for exchange because the transmission rate is relatively low. The beacons themselves are powered by batteries or, more rarely, a direct power supply. Beacons are already in use in many places to locate visitors in a store and send location-dependent offers to the respective terminals. For example, beacons are used at Hamburg Airport to measure the time spent in various stores and reward them with bonuses.
Bluetooth beacons can be used as transmitters for small amounts of data. The data are not transmitted in a point-to-point connection, but rather the Bluetooth beacon sends the data in transmission or broadcast mode, as a so-called advertising packet, which is received by all receiving Bluetooth devices that are within wireless communication range of the transmitting beacon. This means that receiving devices do not need to be paired with the beacon via Bluetooth pairing and/or identified in any way before data transmission. For example, in early versions of Bluetooth, an advertising packet may contain 31 bytes of data. The data can include, for example, a transmitter identification and other data. The term “reception” in this document does not necessarily include the interpretation of the data. This allows data packets having encrypted content to be received and forwarded without recognizing or interpreting the content. In telecommunications, it has always been well known to a person skilled in the art that certain information can be obtained from the reception of signals, regardless of the content of the communication, which information is useful for controlling the transmission. The simplest example of this is measuring the signal strength when receiving wireless signals, which is used in many communication systems to control antenna gain or transmission power.
For details about Bluetooth in general, Bluetooth Low Energy and beacons which use Bluetooth technology, please refer to the Bluetooth specification, which can be accessed online at the website of publicly available from Bluetooth SIG Inc., Kirkland, WA 98033, U.S.A. at https://www.bluetooth.com/specifications/specs.
An embodiment of the patch injector 1 obvious to a person skilled in the art is a modular drug delivery device 1, with a reservoir unit including the disposable reservoir, a reusable drive unit including the drive, and a memory provided in the reservoir unit to store the key.
Evaluated data can only be sent back to the smartphone 3 from the server 4 via the network 6, which data can then be viewed by the person 7 on the smartphone.
The feedback of a confirmation from the server 4 to the drug delivery device 1 (right side in the flowchart in
An advantage of the present invention is that direct, encrypted communication between a drug delivery device and a mobile device is possible according to a point-to-point connection, without the devices involved having to first establish and authenticate such a direct connection before exchanging drug delivery data.
The injection apparatus 800 replaces the shown autoinjector 11 or the drug delivery device 1 from
The sensor 840h is connected to the electronic module 840. As can be seen in
In the present example, the sensor module 840i further includes a microphone with which the microcontroller 840f can determine when the injection apparatus 800 is used for an injection process. The triggering of the injection apparatus 800 and the associated movements in the dispensing mechanism emit a specific acoustic pattern which is recognized by the microcontroller 840f. The microcontroller 840f is now programmed such that it signals the injection to the user and then also signals to the user when the injection process has finished (and, for example, the injection needle can be removed from the tissue). In the present example, the green LED 840b begins to flash as soon as the microcontroller determines that the injection apparatus has been triggered; the optical display can thereby be supported by acoustic signals from the loudspeaker 840e (also by voice output such as: “The injection is in progress, please wait”). At the same time as the LED, the display 840a is activated and the intended injection duration is counted down in seconds in order to give the user an indication of how long the injection process will take. When the counter reaches zero, the injection process is complete. The green LED 840b no longer flashes, but continuously lights up as a sign of completion. Likewise, acoustic feedback can also be provided via the loudspeaker 840e, such as a voice output saying “injection process complete”. The microcontroller registers and saves the time and date of the injection process.
In addition to the parts of the electronic module 840 that have already been described in more detail, the electronic module can optionally comprise a communication module 840j which, by means of Bluetooth, WLAN or GSM, can send data from the injection apparatus 800 or can receive data or commands from the external environment. In the present example, the microcontroller 840f can send information by means of the communication module 840j via Bluetooth, for example in broadcast mode. For example, a nearby smartphone can receive the information. An associated smartphone app can then keep a record of a therapy. The unique identifier for the injection apparatus allows a conclusion to be drawn about the medication, the medication lot, the exact type of injection apparatus, and the production lot of the injection apparatus. The data collected by the app can then be transmitted to the treating physician, the insurer or to a server on the Internet.
The pushbutton 840d has two functions: on the one hand, a service life or function check can be carried out by briefly pressing the pushbutton 840d. If the pushbutton 840d is pressed briefly, the microcontroller 840f checks, on the one hand, whether the timer is running and, on the other hand, whether the sensor module 840i is delivering plausible measured values in which the microcontroller 840f compares the current measured values against a stored library of measured values. If both are the case, the microcontroller 840f issues a corresponding confirmation via the green LED 840b and the loudspeaker 840a. If one of the tests reveals a problem, the microcontroller provides feedback via the red LED 840c and the loudspeaker. A user can thus check at any time whether an injection apparatus can still be used or not.
| Number | Date | Country | Kind |
|---|---|---|---|
| 21189122.1 | Aug 2021 | EP | regional |
| 000570/2022 | May 2022 | CH | national |
This application is a continuation of International Application No. PCT/EP2022/071223, filed Jul. 28, 2022, which in turn claims priority to European Application No. 21189122.1, filed on Aug. 2, 2021 and Swiss Application No. CH000570/2022, filed on May 12, 2022, each of which is incorporated by reference herein, in the entirety and for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/EP2022/071223 | Jul 2022 | US |
| Child | 18423786 | US |
