METHOD FOR ENABLING A PATIENT TO GRANT ACCESS TO THEIR ELECTRONIC IMPLANT BY A TRUSTED CLINICIAN

Abstract

Secure communication is enabled between an external device and a medical device, which may be an implanted device. A key for establishing a secure communication channel between the external device and the medical device is generated by an auxiliary device. The key thus generated is retrieved by the external device from said auxiliary device, and the secure communication channel is then established between the medical device and the external device using the key retrieved from the auxiliary device.

Claims

1. A method for secure communication with a medical device, the method comprising: generating, by an auxiliary device, a key for establishing a secure communication channel between an external device and the medical device; retrieving the key by the external device from the auxiliary device; and subsequently establishing the secure communication channel between the medical device and the external device using the key retrieved from the auxiliary device.

2. The method according to claim 1, wherein the medical device is an implanted medical device.

3. The method according to claim 1, wherein the auxiliary device is a remote control device configured to receive an input from a patient to which the medical device (10 is associated and to control the medical device based on said input.

4. The method according to claim 1, wherein the external device is a programming device configured for controlling the medical device via the secure communication cannel.

5. The method according to claim 1, wherein the step of retrieving the key from the auxiliary device comprises: displaying the key as a graphic code by the auxiliary device and optically detecting the graphic code with an image sensor of the external device.

6. The method according to claim 5, wherein the graphic code is a bar code or a QR-code.

7. The method according to claim 5, which comprises generating the graphic code with at least one of: a time information for limiting a communication between the external device and the medical device via the channel to a pre-defined period of time; location information for limiting the communication between the external device and the medical device to a geographic area; an identity information identifying a person for limiting the communication between the external device and the medical device to the person.

8. The method according to claim 7, wherein the medical device is a device for neurostimulation or a cardiac pacemaker.

9. The method according to claim 7, wherein the medical device is a device for spinal cord stimulation.

10. The method according to claim 1, wherein the step of retrieving the key from the auxiliary device comprises: transmitting the key to a website in a network, causing the key to be displayed as a graphic code at the website, and optically detecting the graphic code with an image sensor of the external device.

11. The method according to claim 10, wherein the graphic code is a bar code or a QR-code.

12. The method according to claim 10, which comprises generating the graphic code with at least one of: a time information for limiting a communication between the external device and the medical device via the channel to a pre-defined period of time; location information for limiting the communication between the external device and the medical device to a geographic area; an identity information identifying a person for limiting the communication between the external device and the medical device to the person.

13. The method according to claim 12, wherein the medical device is a device for neurostimulation or a cardiac pacemaker.

14. The method according to claim 12, wherein the medical device is a device for spinal cord stimulation.

15. A system for secure communication between a medical device and an external device, the system comprising: a medical device, an auxiliary device and an external device; said auxiliary device being configured to generate a key for establishing a secure communication channel between said medical device and said external device; said external device being configured to retrieve the key from said auxiliary device; and said medical device and said external device being configured to establish the secure communication channel therebetween using the key retrieved from the auxiliary device.

16. The system according to claim 15, wherein said auxiliary device is a remote control device configured to receive an input from a patient to which the medical device is associated and to control said medical device based on the input.

17. The system according to claim 15, wherein said external device is a programming device configured for controlling said medical device through said secure communication channel.

18. The system according to claim 15, wherein said auxiliary device comprises an optical display and said auxiliary device is configured to generate the key and to display the key as a graphic code on the optical display, and wherein said external device has an image sensor configured to optically detect the graphic code.

19. The system according to claim 18, wherein the graphic code contains information selected from the group consisting of: a time information for limiting a communication between said external device and said medical device via the channel to a pre-defined period of time; location information for limiting the communication between said external device and said medical device to a geographic area; and an identity information identifying a person for limiting the communication between said external device and said medical device to the person.

20. The system according to claim 15, wherein said auxiliary device is configured to generate the key and to transmit the key to a website in a network for graphically displaying said key on the website as a graphic code, and wherein said external device includes an image sensor configured to optically detect the graphic code from the website.

21. The system according to claim 20, wherein the graphic code contains information selected from the group consisting of: a time information for limiting a communication between said external device and said medical device via the channel to a pre-defined period of time; location information for limiting the communication between said external device and said medical device to a geographic area; and an identity information identifying a person for limiting the communication between said external device and said medical device to the person.

Description

BRIEF DESCRIPTION OF THE DRAWING

[0043] The sole FIGURE of the drawing is a schematic illustration of a system and a method according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0044] Referring now to the sole figure of the drawing in detail, there is shown an exemplary embodiment of a method/system 1 for spinal cord stimulation (SCS). Such a system comprises an implantable medical device 10 for delivering SCS with a first and a second implantable percutaneous lead (not shown) that are implanted into a targeted location in the epidural space. Such leads may be replaced by a paddle lead or other type of SCS leads. Particularly, electrical stimulation pulses are delivered via said leads that comprise a plurality of electrodes. It will be understood, however, and it should be noted that the invention at hand can also be applied to other medical devices.

[0045] To control such an implantable medical device 10 and to grant other devices access to the medical implant 10, the system 1 comprises an auxiliary device PR, here in form of a patient remote control device PR. A display 40 of the remote control device PR is used to display an authorization key in the form of a graphic code C (e.g. barcode, QR-code etc.). The external device CP that shall have access and can be formed by a programming device that is operated by a clinician in order to control the medical device 10 (i.e. change parameters, alter therapy etc.) can then scan the code C using an image sensor 30. The image sensor 30 can be an integral part of the external device CP. However the external device CP may also consist of separate devices that are linked to exchange information (e.g. an image sensor/camera 30 for scanning the code C, which image sensor/camera 30 that is connected to a separate device of the external device for actually programming/controlling the medical device 10). The information encoded in the image or graphic code C contains the (authorization) key which enables the external device CP to communicate with the implant 10. Particularly, this image scanning process introduces the essential element of proximity and consent between the physician and the patient.

[0046] The information encoded in the image or code C may include, but is not limited to: the authorization key (or several such keys), which is designed to authenticate the far-field RF link between the external device CP and the implant 10, an element of time, which one can use to limit the authorization to a certain period of time, an element of location, which one can use to limit the authorization to a geographic area, an identity of a clinician whom the patient intends to authorize.

[0047] Additionally, the system 1 could include a web site 20 where the patient logs in, and where the patient could display a graphic code C to authorize a clinician access. The clinician's external device CP would then scan the code C from the patient portal webpage 20. This would solve the issue of a patient forgetting his/her auxiliary device PR when visiting the clinic. This web-based mechanism requires the auxiliary device PR to be in network contact with the web portal system sometime prior to the clinic visit.

[0048] Additionally, the present invention can be used to control different levels of access. By way of example, the implant 10 may allow a clinician programmer to read information, but requires the optical key exchange described in this invention before allowing therapy changes.

[0049] Additionally, this invention can be used in conjunction with other methods that establish proximity. For example, the user places a permanent magnet over the implant 10 and also performs the optical key exchange described herein.

[0050] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teaching. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention.