EP4381761A1 - Système d'injection à transmission de données simplifiée - Google Patents

Système d'injection à transmission de données simplifiée

Info

Publication number
EP4381761A1
EP4381761A1 EP22758201.2A EP22758201A EP4381761A1 EP 4381761 A1 EP4381761 A1 EP 4381761A1 EP 22758201 A EP22758201 A EP 22758201A EP 4381761 A1 EP4381761 A1 EP 4381761A1
Authority
EP
European Patent Office
Prior art keywords
administration
data
mobile device
bluetooth
administration device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22758201.2A
Other languages
German (de)
English (en)
Inventor
Leos URBANEK
Silas Maechler
Stefan Mangold
Peter Stettler
Urs KLÖTZLI
Adrian Eich
Vinzenz FRAUCHIGER
Lorenz Schmid
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ypsomed AG
Original Assignee
Ypsomed AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from EP21189122.1A external-priority patent/EP4132045A1/fr
Priority claimed from CH000570/2022A external-priority patent/CH719690A2/de
Application filed by Ypsomed AG filed Critical Ypsomed AG
Publication of EP4381761A1 publication Critical patent/EP4381761A1/fr
Pending legal-status Critical Current

Links

Classifications

    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
    • H04W12/00—Security arrangements; Authentication; Protecting privacy or anonymity
    • H04W12/50—Secure pairing of devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L63/00—Network architectures or network communication protocols for network security
    • H04L63/04—Network architectures or network communication protocols for network security for providing a confidential data exchange among entities communicating through data packet networks
    • H04L63/0428—Network architectures or network communication protocols for network security for providing a confidential data exchange among entities communicating through data packet networks wherein the data content is protected, e.g. by encrypting or encapsulating the payload
    • H04L63/0442—Network architectures or network communication protocols for network security for providing a confidential data exchange among entities communicating through data packet networks wherein the data content is protected, e.g. by encrypting or encapsulating the payload wherein the sending and receiving network entities apply asymmetric encryption, i.e. different keys for encryption and decryption
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
    • H04W12/00—Security arrangements; Authentication; Protecting privacy or anonymity
    • H04W12/03—Protecting confidentiality, e.g. by encryption
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3327—Measuring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3584—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or Bluetooth®
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
    • H04W84/00—Network topologies
    • H04W84/18—Self-organising networks, e.g. ad-hoc networks or sensor networks

Definitions

  • the present invention relates to the field of medical injection systems, in particular smart injection systems, which can transmit data from a drug administration device to other devices and which can optionally be easily adapted to the needs of various medical indications if required.
  • Injection systems are known from the prior art, in which administration devices send information about the use of the administration devices via Bluetooth to a mobile device and the mobile device forwards at least some of the information to one or more remote servers. Because this information may include sensitive patient information, this information must be transmitted securely to protect it from unauthorized access. The connection between the mobile device and the administration device must be protected, as well as the connection between the mobile device and remote server computers. In addition, the information must always be stored securely on the respective devices and computers.
  • An encrypted Bluetooth connection is typically used for the connection between the mobile device and the administration device. To do this, the mobile device and administration device must go through a coupling process which, among other things, enables clear identification and assignment between the communication partners. In the Bluetooth communication protocol, this coupling is called "pairing". To further secure the connection, additional encryption can be established at the application level between the mobile device and the administration device. This multi-level security often requires a coupling, pairing and key exchange process initiated by a user. For simpler injection devices such as auto-injectors, securing the connection between the injection device and the mobile device can take more time than the actual injection. For patients, multi-stage protection of the connection is also associated with the risk of incorrect manipulations, especially if they are visually impaired. There is therefore a need for an easy-to-use and nevertheless secure information transmission for injection devices that are used, for example, only for one injection and are disposed of after use.
  • Injection device manufacturers, drug manufacturers, health insurers and caregivers may also have a need to have available injection devices that are as safe and effective as possible. Accordingly, it would be desirable to have an injection device that has a consistent, proven, safe and specified technical design with a constant housing, with additional add-on parts that are firmly and permanently connected to the housing, the shape, feel, surface topography and ergonomics of the injection device can still be adjusted during the production of the device, so that the needs of the medical indication can be taken into account in a simple and inexpensive manner.
  • a medicament in the present context includes any flowable or fluid medicinal formulation which is suitable for controlled administration by means of a cannula or hollow needle into subcutaneous or intramuscular tissue, for example a liquid, a solution Gel or fine suspension containing one or more active medicinal ingredients.
  • a medicament may be a single active ingredient composition or a premixed or co-formulated multiple active ingredient composition from a single container.
  • medicines such as peptides (e.g.
  • insulins insulin-containing medicines, GLP 1-containing and derived or analogous compounds
  • proteins and hormones proteins and hormones
  • biologically derived or active substances substances based on hormones or genes
  • nutritional formulations substances based on hormones or genes
  • enzymes and other substances in both solid (suspended) and liquid form.
  • the term also includes polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable base materials, auxiliary materials and carriers.
  • injection system means a device in which the injection needle is removed from the tissue after a controlled amount of the medicinal substance has been released.
  • the injection needle in an injection system or in an injector does not remain in the tissue for a longer period of several hours.
  • An injection system can include one or more other injection devices in addition to the actual injection device.
  • Bluetooth is well known as a radio technology. So-called Bluetooth beacons are a little less well-known, although for the sake of simplicity the English term will be used in the following.
  • a beacon is a transmitter or receiver based on Bluetooth Low Energy BLE or Bluetooth Smart Technology BST.
  • beacons are powered by batteries or, more rarely, by direct power connection. Beacons are already in use in many places to localize visitors in a shop and to send location-dependent offers to the respective end device. For example, beacons are used at Hamburg Airport that measure the time spent in various shops and reward them with bonuses.
  • the Bluetooth beacons can be used in particular as transmitters for small amounts of data.
  • the data is not transmitted in a point-to-point connection, but the Bluetooth beacon sends the data in broadcast mode, as a so-called advertising packet, which is sent by all receiving Bluetooth devices that are within radio range of the sending beacon are received.
  • an advertising packet may contain 31 bytes of data.
  • the data can include, for example, a transmitter identification and other data.
  • the term "reception" does not necessarily include the interpretation of the data. In this way, data packets with encrypted content can be received and forwarded without recognizing or interpreting the content.
  • Bluetooth Low Energy and beacons which Bluetooth uses as a technology
  • the invention includes a system for the secure transmission of medical information.
  • the information is first transmitted from an administration device to a mobile device and then from the mobile device to a remote server or computer.
  • the administration device can in particular be a patch injector, an auto-injector, an injection pen or an infusion pump.
  • Other possible delivery devices are Devices for inhaling substances through the respiratory tract, both for medical purposes and for recreational purposes.
  • administration devices can also be constructed in a modular manner from components that can or cannot be separated from one another. Typical modules are a reservoir unit with the reservoir for single use, a communication module, and a reusable drive unit with the drive.
  • a patch injector and an auto-injector are taken as examples for the description of the invention below.
  • Such an auto-injector comprises a device for administering fluid medication, as is known to the person skilled in the art from the auto-injectors customary on the market.
  • the auto-injector also includes an electronic controller.
  • the controller can be connected to sensors that can also be provided in the autoinjector and can receive and process their measurement signals.
  • the controller is connected to a memory provided in the autoinjector, in which the controller can store data.
  • a Bluetooth unit is arranged in or on the auto-injector, which 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 broadcast mode in the form of advertising packets described above, ie without an identifier, address or other previously known identification of one or more receiving devices.
  • the Bluetooth unit functions exclusively as a beacon in broadcast mode.
  • medication administration can be monitored via the sensors.
  • the controller can receive the sensor signals, store them and/or transmit them wirelessly via the Bluetooth unit.
  • the administering device comprises, in addition to the elements that are obvious to a person skilled in the art, also several housing-like shells, which can be attached to the outside of the housing of the administering device, preferably in a non-detachable manner.
  • Administration devices such as auto-injectors, with the mentioned housing-like switches are also known from the prior art, in particular from WO 2016179713 A1. What is special about this form is that the electronic elements described above for the autoinjector are at least partially arranged on the housing-like shells.
  • the housing-like shells allow the external appearance of the administration device to be adapted in terms of shape, material, color, ergonomics and/or feel to the needs of the medical indication.
  • the system includes a mobile device.
  • a mobile device This can be a smart phone, a PDA, a tablet, a notebook or a similarly suitable device.
  • the mobile device also contains a Bluetooth unit and a network unit for communication with remote devices.
  • This can be an Ethernet unit, ie a wired network unit, a wireless network unit for a WLAN or a similar system, a mobile radio unit or a mobile telephone unit of any generation.
  • Both Bluetooth and network are common functionalities in the device classes mentioned, are widespread and well known to the person skilled in the art.
  • the system comprises at least one further remote computer or server.
  • the at least one computer does not necessarily have to be a real computer, but one or more cloud instances, ie virtual computers or containers, can also be meant.
  • the at least one computer or server computer includes at least one, possibly virtual, processor, memory and a connection to a network. These components are common components in virtual and real servers and do not require any further explanation in order to understand the invention.
  • the auto-injector as a non-limiting example of an injection or infusion device according to the invention, has a memory in which the controller can store data. At least one cryptographic key is also stored in this memory, with which the controller can encrypt or certify data as required and can either store them in encrypted form in the memory or encrypt them via the Bluetooth unit of the autoinjector. An identifier for the autoinjector is then also stored in the memory.
  • the memory can also be arranged in several parts and distributed over the various modules.
  • the key can be stored in a memory in a reservoir unit in order to ensure assignment to the drug.
  • the controller of the auto-injector can now encrypt administration data, which was recorded and stored by the sensors, for example, and at least broadcast it together with the identifier of the auto-injector as an advertising packet via Bluetooth unit in broadcast mode, for example a sequence of several packets in a row.
  • the identification of the auto-injector is unique and is ideally only assigned once.
  • the administration data also include an absolute or relative time and/or date stamp.
  • the administration data can contain temperatures, sensor data, time measurements, conditions or activities.
  • the mobile device can receive the transmission in the form of the advertising packet via its own Bluetooth unit.
  • a corresponding app is installed on the mobile device, which receives the data.
  • the app does not have a key that would allow the encrypted data to be decrypted.
  • the app recognizes the identification of the auto-injector and, if the auto-injector sends several packets, can classify them correctly.
  • the app can then forward the at least one received advertising packet to a computer or server known to the app via the network unit of the mobile device.
  • the remote computer or server computer can receive the transmission forwarded by the mobile device via its network connection.
  • the device ID can be read on the server.
  • a database is stored on the server, in which the identifiers of the devices are stored. This database also contains a suitable key for each identifier, with which the encrypted data on the server can be decrypted.
  • the server can have access to another server on which the database is stored.
  • the decrypted data can then be used to analyze the administration data or, for example, to check when the auto-injector was used or if a storage temperature was exceeded.
  • the key in the administration device for encrypting the data and the key on the remote computer or server form an asymmetric key pair.
  • This corresponds to the usual asymmetric key pairs made up of a public and secret key, as known to those skilled in the art from the Internet.
  • This has the advantage that data encrypted with the key on the administration device can only be decrypted with the key on the server. Even if a potential attacker could extract a key from the administration device, he cannot access already encrypted data.
  • the pair of keys can also be symmetrical, which also works while accepting the disadvantage mentioned. Since the mobile device does not store any of the keys, it also has no access to the actual administration data.
  • decrypted data that is to be made available to a patient could be processed by the server and sent back to the app. The data can be evaluated and processed beforehand on the server so that they can be displayed on the app in a way that is easy to understand.
  • no Bluetooth pairing takes place between the administration device and the mobile device before, during and after data transmission.
  • the Bluetooth unit of the administration device is not able to carry out a pairing, but is electronically reduced to the essentials, namely the ability to send advertising packets, respectively. to recieve.
  • the reception option is also omitted. This reduction to the essentials saves components and reduces potential sources of error.
  • the administration device has a modular structure.
  • the delivery device can be formed from two modules which can be releasably connected to one another.
  • One module can be an injection or infusion module and the other a communication module.
  • the communication module can in particular 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 auto-injector or as a patch device without any electronics. This would allow, for example, to design the injection or infusion module as a single-use module and the communication module as a reusable module for repeated use.
  • the modules described could each be integrated as components in an administration device, or be coupled to an administration device as an additional module and detachable from it again.
  • the mobile device after receiving an advertising packet from an administration device, also sends an advertising packet as confirmation of receipt via the Bluetooth unit.
  • this acknowledgment of receipt is only sent when the mobile device for its part sends a return received a message from the server that the advertisement package originally coming from the administration device has arrived at the server. The receipt of the package is confirmed in the acknowledgment of receipt to the administration device.
  • the acknowledgment contains the identifier of the delivery device that sent the packet to be acknowledged.
  • a unique identifier of the mobile device is attached. Other parameters such as a packet identification number can also be transmitted as part of the packet length.
  • the administration device can receive and evaluate the confirmation of receipt.
  • the mobile device can receive and acknowledge advertising packets from multiple delivery devices.
  • an administration device can also receive advertising packets, both from a mobile device and from a second administration device.
  • administration devices are close together and can receive advertising packets from one another and acknowledgments of receipt from at least one mobile device, it can be advantageous if the administration devices use the additional information contained in the advertising packet or obtained from it upon receipt.
  • a delivery device that receives such additional information can, upon the next transmission of delivery data, supplement (and encrypt) the delivery data with the information that further delivery devices have been detected in the vicinity.
  • the supplemented information can include the identifier of the additional administration device or devices.
  • proximity resp. the recognition of the presence (that is, the presence) can be meant qualitatively or quantitatively.
  • Qualitative means that a mobile device receives a signal from an administration device.
  • Quantitative 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 at https://www.bliietooth.com/de/specifications/specs/core-specification). Version 5.2 of December 31, 2019 of the Bluetooth Core Specification is hereby fully incorporated by reference into this document.
  • the server If the server then receives such information, it can use the presence of additional evaluations. If the server also knows the other delivery devices (from the database), the transmission reliability of the administration devices can be recognized in one embodiment. Alternatively or additionally, it can also be checked whether all of the recognized administration devices, in particular the medications contained in them, are compatible with one another. If they are not, the server can send a warning to the app. In a further alternative, recommendations can also be sent to the app from the server, in which, for example, a specific order of administration of the various medications is recommended.
  • a plurality of mobile devices can receive information from an administration device at the same time.
  • the Bluetooth units of the mobile devices have implemented the RSSI function (Received Signal Strength Indication) (see the Bluetooth core specification, reference mentioned above). It is thus possible for the mobile device to estimate the receiving distance, ie the distance between transmitter and receiver at the time of data transmission, between the administration device and itself.
  • the mobile device can add the information thus extracted from the RSSI to the advertisement packet to be forwarded.
  • Correspondingly identical advertisement packets, which were forwarded to the server via different mobile devices, can be received on the server. A decision can then be made on the server, for example, which of the identical advertisement packages should be processed further.
  • the information extracted from the RSSI function can help with this. For example, it can be decided on the server that that advertisement packet from a set of identical advertisement packets is kept for which the RSSI function indicates the shortest reception distance between the mobile device and the administration device. The remaining advertisement packets from the set of identical advertisement packets can then be discarded, for example. Alternatively, all packages can also be used together for further evaluations. For example, it can be examined how many mobile devices are present in the transmission range of a single administration device that receive and forward the advertisement packets. Purely theoretically, but advantageously, local clusters of patients and patients who are treating the same disease could be identified. CHARACTERS
  • Fig. 1 shows a first system according to the invention consisting of a patch injector 1, a smart phone 13 and a server 14.
  • FIG. 2 shows a second system according to the invention, consisting of an auto-injector 11 with a built-in electronic module 11a, a smart phone 13 and a server.
  • FIG 3 shows a third system according to the invention consisting of a modular injection device (an auto-injector 11 with an add-on 12), a smart phone and a server.
  • FIG. 4 shows the flow chart of a method according to the invention for transmitting administration data for dose administrations from a reservoir of an administration device.
  • FIG. 5 shows a fourth system according to the invention, in which several administration devices communicate with a server via a mobile device each.
  • FIG. 6 shows the flow chart of a method from FIG. 4 that has been expanded according to the invention, showing the communication with two different mobile devices.
  • figs 7a-e show an optional administration device consisting of an injection device 802 and additional housing shells 830 and 830', the shell 830' comprising the electronic module 840.
  • figs 8a and 8b show detailed views of the electronic module 840.
  • FIG. 1 shows a first system according to the invention.
  • the administration device according to the invention is an electronically operated patch injector 1.
  • Patch injectors are injection devices that are applied directly to the patient's skin Plasters to be stuck on. After sticking on the injector 1, the injection of the fluid medication (not shown) can be started by pressing the start button 1a.
  • the status LED Id shows the current status of the injector 1 using a color code.
  • the progress of the injection can also be observed through the viewing window 1c, through which the drug reservoir (not shown) is visible.
  • the injector further includes sensors (not shown) that can detect the various states of the injector.
  • a capacitive sensor for example, can be arranged in the plaster (not visible in FIG.
  • the administration device 1 is an electronically operated injector.
  • injector 1 also contains a memory in which the administration data can be stored, a unique identifier for the injector and a key for encrypting the administration data.
  • a Bluetooth unit (not shown) is also integrated into the injector 1 and connected to the controller. As soon as it is activated (e.g.
  • the controller can now continuously query the sensors and send any status changes as encrypted data together with the unique identifier via the Bluetooth unit as advertising packets via a broadcast channel 5. If there is no confirmation from the mobile device or smart phone 3, a package can be sent again. The mobile device 3 can then send the advertising packets to the server 4 via the network connection 6 in each case.
  • the server 4 can decrypt and evaluate the data on the basis of the information available in a database (not shown) about the identifier and the matching key.
  • the electronics required for control and communication can be integrated in the patch injector in the form of an electronics module 11a.
  • An embodiment (not shown) of the patch injector 1 that is obvious to the person skilled in the art is a modular construction of the administration device 1 with a reservoir unit with the reservoir for single use and a reusable drive unit with the drive, the memory with the key being provided in the reservoir unit is.
  • FIG. 2 shows an administration device in the form of an auto-injector 11 with an integrated electronics module 11a.
  • FIG. 3 shows a second system according to the invention.
  • the system has a modular structure and consists of an auto-injector 11 without an electronic module and an additional module 12.
  • the rear end of the auto-injector 11 can be pushed into the opening 12a of the add-on 12.
  • the two parts can be snapped together (not shown) to form a unit.
  • the add-on 12 includes the elements of the electronic module 11a with Bluetooth unit according to the invention and can read the key from an NFC memory of the auto-injector for the unique identification of the reservoir.
  • the unit consisting of add-on 12 and autoinjector 11 functions in the same way as the system from FIG.
  • the mobile device also a smart phone 3 here in Figure 3, forwards the packets via the network 6 to the server 4.
  • the server 4 can send evaluated data back to the smart phone 3 via the network 6, which can then be viewed by the person 7 on the smart phone.
  • FIG. 4 shows a flow chart for a method according to the invention for transmitting administration data for dose administrations from a reservoir of an administration device 1 with the following steps:
  • Administration data is in particular information on the quality, success, medication volume, time or duration of an injection or partial steps of an operating sequence carried out for the purpose of administration on the administration device 1.
  • the key stored on the administration device 1 can, for example, form an asymmetric pair of keys with a second key that is stored in a database on the server computer 4 .
  • the keys are distributed in such a way that the data encrypted on the administration device 1 can only be decrypted with the appropriate key on the server computer 4 .
  • These are typically BLE advertisement frames with data packets without recipient information, so that a previous connection (pairing) is not necessary.
  • the server computer 4 can also be implemented on a plurality of processors or computers for the purpose of processing of administration dates Collaborate.
  • the mobile device 3 is typically not able to decrypt the transmitted administration data itself because, according to the invention, the key required for this is only available on the server computer 4 .
  • the acknowledgment of receipt includes at least a unique identifier of the administration device 1, but may also contain other data, such as the identifier of the mobile device 3, elements from the Bluetooth communication protocol or administration data.
  • the mobile device 1 can also display the confirmation of receipt on a screen or notify the user 7 in some other way. Here, too, it is possible to involve the user 7 in the process and, for example, to request manual confirmation, either with each data transmission or also selectively depending on the assessment of the transmission conditions.
  • the feedback of a confirmation from the server 4 to the administration device 1 is not absolutely necessary, but is advantageous and preferred for securing the transmission.
  • the manual acknowledgment of data packets and control of the communication by the user 7 can be omitted or can take place at different points in the described sequence.
  • two positions are mentioned as examples that are particularly suitable for securing data transmission.
  • One advantage of the present invention is that direct, encrypted communication between an administration device and a mobile device corresponding to a point-to-point connection is possible without the devices involved first having to set up and authenticate such a direct connection before exchanging administration data.
  • FIG. 5 shows a system according to the present invention, in which several administration devices 1, 11 each communicate with the server computer 4 via at least one mobile device 3a, 3b. Again, no explicit assignment (pairing) between the mobile device 3a, 3b and the administration device 1, 11 is necessary for the communication, which significantly reduces the complexity of the operation. Such an assignment is very useful for securing the transmission of administration data to the server 4, or also for displaying device-specific information on the mobile device 3a, 3b.
  • An extension of the sequence of FIG. 4 now allows the administration devices 1, 11 to support such an association within a Bluetooth communication range. It can also be seen in FIG. 5 that administration devices 1, 11, which are used at a sufficiently small distance from one another, can also communicate with one another.
  • administration dates and all Information sent by administration device 1 or mobile device 3a in broadcast mode can also be received by administration device 11 and can be used to secure the system, to support the assignment between mobile device 3a, 3b and administration device 1, 11, but also to implement other functions such as a graphic display of the network topology are used.
  • both administration devices 1, 11 can also receive confirmations from both mobile devices 3a, 3b and use them to implement the functions mentioned.
  • each administration device 1, 11 it is possible for each administration device 1, 11 to make an estimate for each data packet received via a Bluetooth broadcast channel 5 as to how large the reception distance is for this data - i.e. the distance between transmitter and receiver - be it a mobile device 3a, 3b or another administration device 1, 11.
  • the evaluation of this information is another important aspect of the present invention.
  • the administration device 1, 11 can issue an unspecified warning that there are several administration devices 1, 11 or mobile devices 3a, 3b in its vicinity.
  • FIG 6 shows an expanded flow chart, which contains the following steps in addition to the process described in Figure 4:
  • the reception distance can be estimated by evaluating the Received Signal Strength Indication (RSSI) sent according to the Bluetooth standard, or by evaluating other suitable information, such as Bit Error Rate (BER) or Quality of Service (QoS).
  • RSSI Received Signal Strength Indication
  • BER Bit Error Rate
  • QoS Quality of Service
  • the server computer 4 can recognize the sender of the administration data from the identification sent along or from any other part of the data.
  • an administration device 1 can also perceive, receive and analyze Bluetooth advertising channels for data packets from other communication partners in the area. In the same way as acknowledgments are received from a mobile device 3, this can also happen for acknowledgments, data packets or other signals that are not intended for the relevant administration device 1, but for example for a second administration device 11.
  • the administration device 1 can advantageously have such a Recognize communication as such and derive from it the presence of a second administration device 11 within the Bluetooth range. Such a presence is preferably also quantified, for example by estimating the reception distance.
  • the administration device 1 adds the presence information to its administration data when sending via the Bluetooth channel 5 . Mobile device 3 forwards this to server 4, and server 4 evaluates it the presence information. In the same way that the server 4 uses the reception distances of the various devices within the range of the Bluetooth technology to assign mobile devices 3 and administration data, the server 4 can use any quantified or non-quantified presence information to form or check assignments and thus ensure the security of the increase communication.
  • FIGS. 7a to 8b show an optional embodiment of an injection device according to the invention (also referred to more generally as an administration device in the general description and below).
  • the injection device 800 comprises two housing-like shells 830 and 830 which can be attached to the housing 802 and together cover the housing 802 approximately.
  • the shell 830' has the same shape as the shell 830 but has an additional electronics module 840.
  • the electronics module 840 is attached to the inside of the shell 830', for example glued or snapped.
  • the shell 830' has openings 830m, 830n and 830o, through which elements of the electronics module are visible or accessible from the outside.
  • the injection device 800 replaces the auto-injector 11 shown or the administration device 1 from FIGS. 1 and 2, and the shells 830, 830' replace the add-on 12 from FIG present invention analogously.
  • FIGS. 8a and 8b show the details of the electronics module 840 integrated in the shell 830'.
  • FIG. 8a shows a first side of the electronics module.
  • the microcontroller 840f is provided as the central control unit. This controls the additional components.
  • the electronic module 840 includes a sensor module 840i, which can include, for example, temperature, humidity, light, pressure sensors and/or a microphone.
  • a loudspeaker or buzzer 840e as an acoustic emitter and the communication module 840j for wireless communication with external devices are also provided on this side of the electronic module 840.
  • the power supply is also provided directly on the electronics module 840, for example in the form of the batteries 840g.
  • the rear side of the electronics module is shown in Figure 8b.
  • a button or button 840d Arranged there are a button or button 840d, two LEDs 840b and 840c and the display 840a.
  • the light-emitting diode 840b is in the form of a green LED and the light-emitting diode 840c is in the form of a red LED, although the coloring could also be different.
  • the 840a display is designed as a simple 7-segment display with two digits. However, it could also be higher resolution LCD or OLED be realized display.
  • Button 840d, the LEDs 840b and 840c and the display 840a are accessible or visible from the outside through the corresponding openings 830o, 830m and 830m in the shell 830'.
  • the sensor 840h is connected to the electronic module 840. As seen in Figures 8a and 8b, the sensor 840h includes a pin 840k. This pin 840k is movably mounted on the sensor 840h. When shells 830 and 830' are attached to housing 802, pin 840k is moved into sensor 840h by a rib on shell 830 (not shown) and closes an electrical contact present in sensor 840h. This contact closure is evaluated by the microcontroller 840f. In the present example, the contact closure means that the injection device, including a product container, is fully assembled, since the housing-like shells 830 and 830' are the last parts to be attached to the injection device.
  • the microcontroller activates an internal lifetime timer and the existing sensors 840i, in particular an existing temperature sensor.
  • the lifetime timer when it expires, signals when the injector should no longer be used because the drug present in the product container has expired.
  • the timer is therefore programmed during assembly specifically for the medication used and its shelf life.
  • the signaling is done optically via the red LED 840c, which can flash in particular after the end of the period, and via the loudspeaker 840e, which can emit acoustic signals.
  • the aforementioned temperature sensor in sensor 840i measures the temperature of the injection device, with the corresponding signal being evaluated by microcontroller 840f and stored in an internal memory (not explicitly shown).
  • the microcontroller, LEDs, loudspeakers and/or the display activates to externally signal that the injection device should no longer be used.
  • the emitted signals differ from those that are emitted after the lifetime has expired.
  • the sensor module 840i also includes a microphone, with which the microcontroller 840f can detect when the injection device 800 is used for an injection.
  • the triggering of the injection device 800 and the associated movements in the dispensing mechanism emit a specific acoustic pattern which is recognized by the microcontroller 840f.
  • the 840f microcontroller is now programmed in such a way that it signals the user of the injection and then also signals when the injection process is complete (and, for example, the injection needle can be removed from the tissue.
  • the green LED 840b starts flashing as soon as the microcontroller Triggering of the injection device is detected, the optical display can be supported by acoustic signals from the loudspeaker 840e (also by voice output such as: "The injection is running, please wait”).
  • the display 840a is activated at the same time as the LED and the intended duration of the injection is shown will count down in seconds to give the user an indication of how much longer the injection process will take.
  • the counter reaches zero, the injection process is complete.
  • the green LED 840b will now stop flashing and stay on to indicate the conclusion.An acoustic feedback can also continue ing via the speaker 840e, such as a voice output “Injection process complete”.
  • the microcontroller registers and saves the time and date of the injection process.
  • the electronic module can optionally include a communication module 840j, which sends data out of the injection device 800 by means of Bluetooth, WLAN or GSM or transmits data or Can receive commands from outside.
  • the microcontroller 840f can send information via the communication module 840j via Bluetooth, preferably in broadcast mode.
  • a nearby smartphone can receive the information.
  • An associated app on the smartphone can then keep a log of a therapy.
  • the unique identifier of the injection device allows conclusions to be drawn about the drug, the drug lot, the exact type of injection device and the production lot of the injection device.
  • the data collected by the app can then be transmitted to the treating doctor, the insurer or to an internet server.
  • the button 840d has two functions. On the one hand, by briefly pressing the button 840d, a service life check or Functional check to be carried out. If the button 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 supplies 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 gives the green LED 840b and the Loudspeaker 840a from a corresponding confirmation. If one of the checks reveals a problem, the microcontroller gives feedback via the red LED 840c and the loudspeaker. A user can thus check at any time whether an injection device can still be used or not.

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Abstract

L'invention concerne un système d'injection dans lequel les données sont transmises d'un dispositif d'administration de médicaments à un dispositif mobile via une connexion Bluetooth sans fil et, de là, à un ordinateur serveur via une connexion réseau. Un nouveau procédé permet de chiffrer les données d'administration sur le dispositif d'administration et de les envoyer via le canal de diffusion Bluetooth sans qu'un appariement soit effectué. Les données d'administration sont déchiffrées uniquement sur l'ordinateur serveur, et affectées au dispositif d'administration. Ce processus peut être pris en charge par le dispositif mobile et le dispositif d'administration qui observent le canal de diffusion Bluetooth et estiment la distance qui sépare l'expéditeur concerné des données transmises du dispositif mobile ou du dispositif d'administration.
EP22758201.2A 2021-08-02 2022-07-28 Système d'injection à transmission de données simplifiée Pending EP4381761A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP21189122.1A EP4132045A1 (fr) 2021-08-02 2021-08-02 Système d'injection à transmission simplifiée de données
CH000570/2022A CH719690A2 (de) 2022-05-12 2022-05-12 Injektionssystem und Verfahren zur Übertragung von Verabreichungsdaten.
PCT/EP2022/071223 WO2023012030A1 (fr) 2021-08-02 2022-07-28 Système d'injection à transmission de données simplifiée

Publications (1)

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EP4381761A1 true EP4381761A1 (fr) 2024-06-12

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EP22758201.2A Pending EP4381761A1 (fr) 2021-08-02 2022-07-28 Système d'injection à transmission de données simplifiée

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US (1) US20240157062A1 (fr)
EP (1) EP4381761A1 (fr)
WO (1) WO2023012030A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2020356529A1 (en) * 2019-09-25 2022-05-19 Janssen Pharmaceuticals, Inc. Interconnection of drug administration systems

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9022988B1 (en) * 2010-05-07 2015-05-05 Kavan J. Shaban System and method for controlling a self-injector device
CH711066A2 (de) 2015-05-13 2016-11-15 Tecpharma Licensing Ag Verbesserte Injektionsvorrichtung.
CA3302063A1 (en) * 2019-02-27 2026-03-02 Eli Lilly And Company Medication delivery device with sensing system
EP3734605A1 (fr) * 2019-04-30 2020-11-04 Ypsomed AG Transmission sécurisée de données d'administration de médicaments
CH714994A2 (de) * 2019-08-20 2019-11-15 Tecpharma Licensing Ag Elektronikmodul mit Sensoreinheit und Injektionssystem.

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WO2023012030A1 (fr) 2023-02-09

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