CROSS-REFERENCE TO RELATED APPLICATIONS

This application is the National Stage of International Patent Application No. PCT/CN2016/100296 filed Sep. 27, 2016, the disclosure of which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention generally relates to the field of medical appliance, specifically to a delivery safety ensuring method and a wearable medical system using this method.

BACKGROUND OF THE INVENTION

Smart phones have been becoming more and more indispensable in the modern life, and the trend of making the mobile applications the universal solution for everything is irreversible. Referring to wearable medical devices, running an application to control the medical device using a smart phone with every other function instead of using an additional handset device with no other function is much more convenient and preferred by users with no doubt. But the safety of the communication between the medical device and the smart phone is a big concern. As a price paid for the unprecedented convenience, compromise in the safety of using the smart-phone-controlling medical device is a collateral damage. Because the smart phone has access to the Internet, it is vulnerable to program failure caused by external viruses or malicious external attacks, making the instructions from the smart phone to the medical device untrustworthy, resulting in possible threat to the health and even life safety of the user. However, measures for establishing secure communications between a wearable medical device and a smart phone using mainstream wireless communication techniques are limited.

Pressing the physical buttons set on the wearable medical device for confirmation of the instructions from the smart phone provides one solution, but it requires the user to roll up her or his clothes causing inconvenience. In other solutions such as transmitting encrypted information regarding an encryption key as disclosed in US2014153719A1, or generating a PIN code by the medical device for a user to input in a controlling device as disclosed in EP2001188A1, or generating a communication using the NFC protocol between the medical device and a remote controller as disclosed in U.S. Pat. No. 9,391,670B2, the problem of the vulnerability of the medical device to unauthorized or unintended instructions from the open network remains because all these authentication or identification measures involve devices accessing an open network. For that reason, proximity telemetry communication between the medical device and an external device with no Internet access is applied which greatly enhances the safety of delivery, but due to the immense impact a delivery device may have on human health, additional ensuring method is still required.

SUMMARY OF THE INVENTION

To overcome shortcomings in the prior art mentioned above, one purpose of the present invention is to provide a delivery safety ensuring method involving two major steps using alternative physical keys and independent authentication tools, comprising:

Selecting and inserting an alternative physical key carrying a proper operating mode configured to restrict a delivery amount within a pre-determined range into a wearable medical device by a user;

Determining, via a processor, whether a delivery instruction given by a smart device is within the pre-determined range of the selected physical key by the wearable medical device;

Requiring, via the processor, for authentication of the delivery instruction or a suspension instruction from the smart device by the wearable medical device;

Using an authentication tool independent of the smart device to send an authentication information to a receiver set in the wearable medical device by the user, wherein the communication between the authentication tool and the receiver is a proximity communication without any direct physical contact being needed;

Establishing, via the processor, a secure communication with the smart device by the wearable medical device if the requirement for authentication is satisfied;

Instructing, via the processor, an alert system set in the wearable medical device to give a feedback to the user if the requirement for authentication is satisfied.

Alternatively, the delivery safety ensuring method further comprises declining, via the processor, to establish a secure communication between the smart device and the wearable medical device if the delivery instruction from the smart device is out of the pre-determined range of the selected physical key, or the requirement for authentication is unsatisfied.

Alternatively, the authentication tool is a portable item without Internet access or a movement made by the user.

Alternatively, the receiver is a built-in sensor set in the wearable medical device.

Alternatively, the receiver is a magnetic sensor, and the authentication tool is a portable item made of or containing magnetic material.

Alternatively, the authentication tool is a portable item made of or containing metal material, and the receiver is one of a capacitive sensor, an inductive sensor and an eddy-current sensor.

Alternatively, the receiver is a linear accelerometer, and the authentication tool is a linear movement made by the user which is one or a combination of jumping, squatting and tapping the wearable medical device through clothing.

Alternatively, the receiver is a gyroscope sensor, and the authentication tool is a twisting movement made by the user.

Alternatively, the receiver is an ultrasonic receiving sensor, and the authentication tool is a portable item with an ultrasonic transmitter.

Alternatively, the receiver is a built-in RFID reader or tag, and the authentication tool is a portable item with a corresponding RFID tag or reader.

Alternatively, the receiver is a built-in NFC reader or tag, and the authentication tool is a portable item with a corresponding NFC tag or reader.

Alternatively, the alert system set in the wearable medical device comprises a buzzer and a vibration motor.

Alternatively, the operating mode comprises one or a combination of a basal rate delivery mode, a programmable basal rate delivery mode, a bolus dose delivery mode, a delivery suspension mode, a system locking mode and a wireless control mode.

The other purpose of the present invention is to provide a wearable medical system using the above-identified delivery safety ensuring method, comprising a delivery device which comprises a processer, a receiver, an alert system and alternative physical keys with respective operating modes; as well as an authentication tool independent of a smart device, with all the components functioning as mentioned in the delivery safety ensuring method.

Alternatively, the alternative physical keys further carry pre-determined setting rules, configured to limit acceptable orders to changing system settings or executing special instructions from the smart device.

Compared to prior arts, the present invention has advantages in the following ways: Firstly, the alternative physical keys are designed with pre-determined operating modes which restrict the amounts of drug fluid to be delivered to the user within a certain range independent of the instructions from a smart phone, so an instruction of delivery amount out of the pre-determined range of an alternative physical key selected and inserted into the wearable medical device by the user will not be accepted by the processor and no active communication between the medical device and the smart phone would be established. Due to the reason that the alternative physical keys have no access to open network, there is hardly a chance of them being invaded by external viruses. Secondly, when a delivery amount of an instruction from the smart phone fits in the restricted range of a selected physical key, the processor requests for a further safety ensuring measure and an independent third-party item or movement is involved as an authentication tool. If the requirement of authentication is satisfied, a secure communication of the medical device and the smart phone will eventually be established. Since the independent authentication tool communicates with the receiver in the medical device using proximity communication which requires no open network access, this way of authentication further enhances the safety of the delivery, especially against malicious external attack via network. Last but not least, the proximity communication applying electric or magnetic field, NFC or RFID protocol, a linear or twisting movement which can be sensed by an accelerometer or a gyroscope requires no rolling up clothes of the user, which improves the convenience of using the wearable medical device by both protecting the user's privacy and keeping the user warm.

