Device for the protected operation of neuroprostheses and method therefor

• US 6,493,587 B1
• Filed: 08/09/2000
• Issued: 12/10/2002
• Est. Priority Date: 12/23/1999
• Status: Expired due to Term

• Current Assignee: Pixium Vision SA
• Original Assignee: Intelligent Implants GmbH
• Inventors: Ortmann, Valerij, Hünermann, Ralph, Becker, Michael, Eckmiller, Rolf
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US09/635,016
• Time in Patent Office: 853 Days
• Field of Search: 607/60, 607/31, 607/32, 607/30, 607/45, 607/54, 607/56, 607/57, 623/11.11, 623/24
• US Class Current: 607/31
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
• CPC Class Codes: H04L 63/10 for controlling access to devices or network resources

Abstract

The invention relates to a system for the protection of neuroprosthesis operation against unauthorized access to the function or operating data. The system is assigned to neuroprostheses for treating functional disorders of the nervous system. This neuroimplant protection system (NIS) comprises at least one neuroprosthesis component which is in contact or operational connection with nerve tissue. Neuroprosthesis operation takes place only during the period of a specific authorization and/or comprises an authorized data transmission between external component and implanted component and/or an authorized communication for monitoring and/or defining the neuroprosthesis functional state. The communication between external and implanted component is in encrypted form.

Claims

1. A method for operating a neuroprosthesis in the central nervous system within the skull, the spinal cord or peripheral nerves connected to the spinal cord, or a vision prosthesis or hearing prosthesis, the neuroprosthesis comprising an implanted internal component and a non-implanted external component, a wireless data transmission being provided between the internal component and the external component, wherein some or all of the data are transmitted only of an authorization signal transmitted by the external component to the internal component has been tested and accepted and the authorization signal~is automatically changed at non-periodic time intervals.

2. The method according to claim 1 wherein the authorization signal accepted by the internal component is assigned exclusively to one external component or assigned exclusively to two external components.

3. The method according to claim 1 wherein the authorization signal accepted by the internal component is part of a data stream that is transmitted from the external component to the internal component, the data stream being encrypted using sets of public and private keys, the public and private keys being automatically changed at random time intervals.

4. The method according to claim 1 wherein the authorization signal is checked in the internal component by means of a programmable memory.

5. The method according to claim 1 wherein the authorization signal is checked in the internal component by means of a fixed topological semiconductor structure.

7. The method according to claim 1 wherein in the event of an operational fault with a second authorization method, a switching-off or an emergency program of the internal component can be carried out.

8. The method according to claim 7 wherein the second method employs a functional principle other than the first method.

9. The method according to claim 1 wherein the internal component exchanges data during operation with a further implanted component.

10. The method according to claim 1 wherein the data is transmitted in encrypted form.

11. The method according to claim 10 wherein the internal component contains a programmable key or a key that can be defined by means of a fixed topological semiconductor structure.

12. The method according to claim 1 wherein after a number of tested and unaccepted authorization attempts, the acceptance of further authorization attempts is temporarily or permanently blocked and in that the blocking can be cancelled only by means of an authorization signal not necessary in normal operation.

13. The method according to claim 1 wherein after an accepted authorization, no status signal indicating the authorization is transmitted from the internal component to the external component.

6. The method according to 1 wherein for the data transmission or functioning of the internal component, at least two operating states are possible that can be activated by means of different authorization signals.

14. A method for operating a neuroprosthesis in the central nervous system inside the skull, the spinal cord or peripheral nerves connected to the spinal cord, or a vision prosthesis or hearing prosthesis, the neuroprosthesis comprising an implanted internal component and a non-implanted external component, the internal component furthermore being in contact or operative connection with the nerve tissue and being able to monitor, influence or replace a function of the nerve tissue during operation, wherein the internal component is operated only if an authorization signal transmitted by the external component to the internal component has been tested and accepted and the authorization signal is automatically changed at non-periodic time intervals.

16. The method according to claim 14 wherein the authorization signal is checked in the internal component by means of a programmable memory and wherein the authorization signal is configured using features specific to an implant wearer.

15. The method according to clam 14 wherein the authorization signal accepted by the internal component is part of a data stream that is transmitted from the external component to the internal component, the data stream being encrypted using sets of public and private keys, the public and private keys being automatically changed at random time intervals.

17. A method for operating a neuroprosthesis in the central nervous system inside the skull, the spinal cord or peripheral nerves connected to the spinal cord, or a vision prosthesis or hearing prosthesis, the neuroprosthesis comprising an implanted internal component and a non-implanted external component, the internal component furthermore being in contact or operative connection with the nerve tissue and being able to monitor, influence or replace a function of the nerve tissue during operation, wherein the internal component is operated only if an authorization signal transmitted by the external component to the internal component has been tested and accepted and wherein the acceptance of the authorization signal is dependent on the internal component detecting an unusual state of an implant wearer.

18. The method according to claim 17 wherein the unusual state is selected from the group consisting of sleeping and altered brainwaves and altered pH and altered temperature and altered blood circulation.