Secure wireless connections for medical devices

Patent metadata

Field	Value
Publication number	US-12537098-B2
Application number	US-202318311106-A
Country	US
Kind code	B2
Filing date	May 2, 2023
Priority date	Nov 23, 2020
Publication date	Jan 27, 2026
Grant date	Jan 27, 2026

Abstract

A method for establishing a secure connection for transmitting data between a medical device system and a mobile device with wireless communication module is provided, where the medical device system comprises one or multiple devices, where the method comprises multiple steps. On the basis of a non-secure connection, a secure connection is established on the basis of a joint movement of mobile device and at least one device of the medical device system. Movement data are evaluated for this purpose.

First claim

What is claimed is:

1 . A method for establishing a secure connection for transmitting data between a medical device system and a specialized app of a mobile device with a Bluetooth wireless communication module, wherein the medical device system comprises one or more devices, wherein the method comprises steps of:
placing the medical device system and the mobile device into a mode that allows the establishment of a secure, end-to-end encrypted connection between the medical device system and the specialized app of the mobile device; establishing a non-secure, wireless connection between at least one device of the medical device system and the mobile device, the at least one device comprising an electronic communication module for Bluetooth wireless communication, wherein the established wireless connection is an encrypted Bluetooth Just Works pairing; and subjecting the at least one device and the mobile device to joint movement, the joint movement comprising simultaneous, directionally aligned movement, i. wherein, during the joint movement, the at least one moving device and the specialized app of the mobile device each generate information based at least partly on the joint movement, ii. wherein, during the joint movement, the at least one moving device and the specialized app of the mobile device exchange at least fragments of the respectively generated information mutually and continuously in real time over the established encrypted Bluetooth pairing, iii. wherein the information fragments mutually and continuously exchanged over the non-secure, encrypted Bluetooth pairing serve for mutual identification and authentication of the medical device system and the specialized app of the mobile device, and wherein the secure, end-to-end encrypted connection using the specialized app is established over the established encrypted Bluetooth pairing based upon i.-iii.

2 . The method according to claim 1 , wherein the mutually and continuously exchanged information fragments further serve to encrypt the secure connection.

3 . The method according to claim 1 , wherein the generated information comprises movement data and identification data non-transiently stored in the medical device system and in the specialized app of the mobile device, and wherein the identification data is used with the movement data for establishing the secure connection.

4 . The method according to claim 1 , wherein the medical device system comprises an injection pen and an electronic add-on for the injection pen, and wherein the at least one moving device is the add-on, the add-on configured to add data of the injection pen to the generated information and transmit said data and generated information.

5 . The method according to claim 1 , wherein the at least one device and the mobile device are held together for the joint movement and form a kinematic unit for the joint movement.

6 . The method according to claim 1 , wherein the at least one moving device of the medical device system and the mobile device each comprise at least one movement sensor configured to generate measurement signals for use in generating the generated information.

7 . The method according to claim 1 , wherein, for establishing the Bluetooth Just Works pairing, at least one code is exchanged between the at least one device and the mobile device.

8 . The method according to claim 1 ,
wherein the at least one device comprises a first near-field communication unit (“NFC unit”) for wireless communication, and the mobile device comprises a second NFC unit for wireless communication, and wherein, for the Bluetooth Just Works pairing, keys are exchanged between the at least one device and the mobile device by the first NFC unit and the second NFC unit.

9 . A method according to claim 1 , wherein, during the joint movement of the at least one device and the mobile device, transmission power of the Bluetooth wireless communication module of the at least one device and the Bluetooth wireless communication module of the mobile device can be reduced due to a spatial proximity of the at least one device and the mobile device during the joint movement.

10 . A medical device system, wherein the medical device system comprises one or more devices, wherein at least one device of the medical device system comprises:
an electronic controller communicatively coupled to a Bluetooth wireless communication unit such that the at least one device is configured to send data to and receive data over a non-secure, encrypted Bluetooth Just Works pairing; and at least one movement sensor communicatively coupled to the electronic controller, wherein the electronic controller is configured to receive electronic signals from the at least one movement sensor and generate information for use in establishing a secure, end-to-end encrypted connection with a specialized app of a mobile device, wherein the information is generated and continuously exchanged by the wireless communication unit over the non-secure, encrypted Bluetooth pairing during a joint movement between the at least one device and the mobile device, and the generated information is used at least partly for establishing the secure, end-to-end encrypted connection using the specialized app over the non-secure, encrypted Bluetooth pairing.

11 . The medical device system according to claim 10 , wherein the medical device system is an infusion pump.

12 . The medical device system according to claim 11 , wherein the infusion pump is configured as a modular patch pump for wearing directly on skin.

13 . A method according to one of claim 1 , wherein the placing of the medical device system and the mobile device into a mode that allows a new secure connection between the medical device system and the mobile device takes place via a movement of the medical device system and/or the mobile device.

Assignees

• Ypsomed Ag

Inventors

• Labudde Marc
• Bosshard Simon Martin

Classifications

• A61M5/14

  Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor · CPC title

• G16H40/60 Primary

  for the operation of medical equipment or devices · CPC title

• H04L63/0876

  based on the identity of the terminal or configuration, e.g. MAC address, hardware or software configuration or device fingerprint · CPC title

• H04L63/0869

  for achieving mutual authentication (cryptographic mechanisms or cryptographic arrangements for mutual authentication H04L9/3273) · CPC title

• H04L63/0428

  wherein the data content is protected, e.g. by encrypting or encapsulating the payload · CPC title