Conditional requirements for remote medical device programming

• US 20050283198A1
• Filed: 06/18/2004
• Published: 12/22/2005
• Est. Priority Date: 06/18/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Masoud, Javaid, Petersen, Christopher M., Willenbring, James E., Haubrich, Gregory J., Jennings, David S., Vandanacker, John P.
• Granted Patent: US 7,565,197 B2
• Time in Patent Office: Days
• 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;

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

aborting the remote programming session if one or more of the remote programming requirements is not satisfied.

2. The method according to claim 1 further including updating a programming log file upon implementing or aborting 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 13 wherein the programming condition requirement is a patient condition.

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

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

18. 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.

19. The method of claim 18, further including verifying a complete transmission of the remote programming instruction set from the centralized programming instrument to the remote medical device.

20. The method of claim 18, 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.

21. The method of claim 18, further including verifying a remote medical device status has not changed between the time the remote programming instruction set is entered in the centralized programming instrument and the time the remote programming instruction set is transferred to the remote medical device.

22. A system for remotely programming a medical device, comprising:

a centralized programming instrument;

a data communications network;

a programmable medical device capable of communicating with the centralized programming instrument via the data communications network; and

a verification module for determining if one or more remote programming requirements are satisfied and, if the one or more remote programming requirements are satisfied, allowing a remote programming instruction set to be transferred from the centralized programming instrument to the remote medical device wherein the remote programming instruction set is implemented by the remote medical device and, if the one or more remote programming requirements are not satisfied, preventing a set of remote programming instructions from being transferred to or implemented by the remote medical device.

23. The system of claim 22 wherein at least a portion of the verification module is implemented in the centralized programming instrument.

24. The system of claim 22 wherein at least a portion of the verification module is implemented in the remote medical device.

25. The system of claim 22 wherein at least a portion of the verification module is implemented in the data communications network.

26. A system for remotely programming a medical device, comprising:

means for generating a remote programming instruction set;

means for transmitting the remote programming instruction set from the generating means to the medical device;

means for verifying one or more predetermined remote programming requirements are satisfied, wherein, if one or more remote programming requirements are satisfied, verifying means allows the remote programming instruction set to be transferred from the generating means to the medical device and implementation of the remote programming instruction set by the medical device, and, if one or more remote programming requirements are not satisfied, verifying means prevents a set of remote programming instructions from being transferred to or implemented by the remote medical device.

27. A computer readable medium containing instructions that when implemented in a medical device programming system, cause the system to:

determine if one or more predetermined remote programming requirements are satisfied;

allow a remote programming instruction set generated by a centralized programming instrument to be transferred to and implemented by a medical device if one or more remote programming requirements are determined to be satisfied; and

prevent the remote programming instruction set to be transferred to or implemented by the medical device if one or more remote programming requirements are determined not to be satisfied.