Conditional requirements for remote medical device programming

• US 7,565,197 B2
• Filed: 06/18/2004
• Issued: 07/21/2009
• Est. Priority Date: 06/18/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Jennings, David S., Vandanacker, John P., Masoud, Javaid, Petersen, Christopher M., Willenbring, James E., Haubrich, Gregory J.
• Primary Examiner(s): Bockelman; Mark W
• Assistant Examiner(s): Dinga; Roland
• Application Number:
  US10/871,591
• Publication Number:
  US 20050283198A1
• Time in Patent Office: 1,859 Days
• Field of Search: 607/30, 607/32, 607/60, 607/31, 128/903, 128/904
• US Class Current: 607/30
• 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: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A remote programming method is provided for safe and secure programming of a medical device at a remote location. A centralized programming instrument for use by a clinician or third party is provided with a network communication connection with a remote external medical device, such as a home programmer or monitor. The external medical device is located in the vicinity of a patient having an implantable medical device (IMD) and is in bi-directional telemetric communication with the IMD to allow instructions received from the centralized programming instrument to be transferred to the IMD. The remote programming method used for transferring information between the central programming instrument and an IMD includes measures to promote safe and secure remote programming of the IMD, which measures may include authorization requirements, programming condition requirements, implementation of programmed data requirements, and maintenance of a remote programming log.

Claims

1. A method, comprising:

initiating a remote programming session using a centralized programming instrument capable of communicating with a remote medical device;

verifying that one or more predetermined remote programming requirements are satisfied;

entering remote programming instructions at the centralized programming instrument;

transmitting the remote programming instructions from the centralized programming instrument to the remote medical device; and

implementing remote programming instructions in the remote medical device if the one or more remote programming requirements are satisfied;

wherein verifying the one or more remote programming requirements are satisfied comprises verifying a remote medical device status has not changed between a time the remote programming instructions are entered and a time the remote programming instructions are received by the remote medical device.

2. The method according to claim 1 further including updating a programming log file upon implementing the remote programming session.

3. The method of claim 1 wherein the remote programming requirements includes one or more authorization requirements, which if satisfied, allow the remote programming session to proceed.

4. The method of claim 3 further including verifying a user identification.

5. The method of claim 3 further including verifying the central programming instrument identification.

6. The method of claim 3 further including verifying a targeted patient identification.

7. The method of claim 3 further including verifying the remote medical device identification.

8. The method of claim 3 further including verifying a third party authorization.

9. The method of claim 1 further including limiting remote programming capabilities based on the remote programming requirements that are satisfied.

10. The method of claim 1 further including generating a notification signal to a patient having the medical device of an attempt to verify a remote programming requirement.

11. The method of claim 1 further including encrypting and decrypting remote programming instructions.

12. The method of claim 11 wherein the method for encrypting and decrypting the remote programming instructions includes a method selected from the group of:

a public and private key system;

a digital certificate or signature;

an unencrypted data header;

variable encryption code;

a variable data starting point.

13. The method of claim 1 wherein the remote programming requirements include one or more programming condition requirements, which when satisfied allow a remote programming instruction set to be transferred to the remote medical device.

14. The method of claim 13 wherein the programming condition requirement is a temporal condition.

15. The method of claim 1 further comprising aborting the remote programming session if one or more of the remote programming requirements is not satisfied.

16. The method of claim 13 wherein the programming condition requirement is a patient condition.

17. The method of claim 13 wherein the programming condition is a logistical condition.

18. The method of claim 13 wherein the programming condition is a medical device condition.

19. The method of claim 1 wherein the remote programming requirements include one or more implementation requirements which, when satisfied, allow a remote programming instruction set to be implemented by the medical device.

20. The method of claim 19, further including verifying a complete transmission of the remote programming instruction set from the centralized programming instrument to the remote medical device.

21. The method of claim 19, further including verifying the remote programming instruction set received by the medical device matches the remote programming instruction set transferred from the centralized programming instrument.

22. The method of claim 19, further including verifying a remote medical device status has not changed between the time the remote programming instructions are entered in the centralized programming instrument and time the remote programming instructions are transferred to the remote medical device.

23. The method of claim 1 wherein the one or more remote programming requirements further comprise requiring the patient affirm that a remote programming session may proceed.

24. The method of claim 1 wherein verifying the remote medical device status has not changed comprises verifying the status has not changed between a time the remote programming instructions are transmitted from the centralized programming instrument and a time the remote programming instructions are received by the remote medical device.

25. The method of claim 1, wherein verifying the remote medical device status has not changed comprises:

setting a state token value to an initial value of a non-repeating sequence of values, the state token corresponding to a set of IMD parameters;

updating the state token value to a next value of the non-repeating sequence of values in response to a change in an IMD parameter included in the set of IMD parameters;

retrieving a most recent state token value upon initiating the remote programming session;

transmitting the most recent state token value with the remote programming instructions from the centralized programming instrument to the remote medical device; and

comparing the most recent state token value to a current state token value.

26. The method of claim 25 wherein the non-repeating sequence of values is a time-date stamp.

27. The method of claim 25 wherein the non-repeating sequence of values is a random sequence.

28. The method of claim 25 wherein the non-repeating sequence of values is non-repeating over a finite bound corresponding to a maximum expected time between transmitting remote programming instructions and receiving remote programming instructions.

29. The method of claim 25 wherein the remote medical device is an implantable medical device and transmitting the remote programming instructions comprises transmitting the data to a remote external medical device capable of communicating with the implantable medical device and further transmitting the remote programming instructions from the external medical device to the implantable medical device,

the remote external medical device receiving the updated state token value whenever the implantable medical device and the external medical device are in communication.

30. The method of claim 29 wherein a time delay occurs between transmitting from the centralized programming instrument to the external medical device and transmitting from the external medical device to the implantable medical device.

31. The method of claim 25 further comprising identifying critical state tokens and non-critical state tokens and wherein implementing remote programming instructions comprises enabling implementation of remote programming instructions when non-critical state tokens have changed and critical state tokens have not changed.

32. The method of claim 14 wherein the temporal condition requires a time delay before implementation of the remote programming instructions.