System and method for remotely programming a patient medical device

• US 20070185547A1
• Filed: 01/08/2007
• Published: 08/09/2007
• Est. Priority Date: 01/09/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hoyme, Kenneth, Jelatis, George, Franke, Karen
• Granted Patent: US 8,588,912 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system and method for remotely programming a patient medical device (PMD) is presented. Programming instructions specified remotely are translated into commands formatted for a PMD to control functionality thereof. Correctness of the PMD-formatted commands is checked. Patient consent to modify the functionality of the PMD is confirmed. Application of the PMD-formatted commands to the PMD is controlled during a programming session initiated and performed remotely. The application of the PMD-formatted commands is confirmed through interrogation of the PMD to verify the functionality modified.

Claims

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

a regulated device to translate programming instructions specified remotely into commands formatted for a patient medical device (PMD) to control functionality thereof, and to check correctness of the PMD-formatted commands;

a remote programming device to confirm patient consent to modify the functionality of the PMD, and to control application of the PMD-formatted commands to the PMD during a programming session initiated and performed remotely, wherein the application of the PMD-formatted commands is confirmed through interrogation of the PMD to verify the functionality modified.

2. A system according to claim 1, wherein the PMD-formatted commands are applied by the remote programming device to the PMD in one of real time or deferred time.

3. A system according to claim 1, further comprising:

a user interface to limit the programming instructions to selections corresponding to a subset of all possible commands for the PMD.

4. A system according to claim 1, wherein the regulated device confirms validity of the PMD-formatted commands as part of the correctness checking, further comprising at least one of:

permissible commands to ensure that the PMD-formatted commands are allowed;

parameter limits to verify that any values included as part of the PMD-formatted commands are within constrained limits; and

;

interactive limits to check the PMD-formatted commands against existing PMD commands and state.

5. A system according to claim 1, further comprising:

a security infrastructure to ensure secure transmittal of the PMD-formatted commands, comprising;

prior to transmittal, a signing device to digitally sign the PMD-formatted commands; and

following transmittal, a verifier to confirm an identify of a source of the PMD-formatted commands as legitimate and to ensure that the PMD-formatted commands were not altered during transit.

6. A system according to claim 5, wherein the verifier comprises at least one of a remote programming device and a PMD.

7. A system according to claim 5, further comprising:

an approval mechanism to receive caregiver approval of the PMD-formatted commands; and

a secure storage, further comprising;

a security scheme in which the PMD-formatted commands are digitally signed, stored in the secure storage, and marked for delivery only following receipt of the caregiver approval;

a security scheme in which the PMD-formatted commands are stored in the secure storage, and digitally signed for delivery only following receipt of caregiver approval;

a security scheme in which the PMD-formatted commands are digitally signed, stored in the secure storage, digitally signed again, and marked for delivery only upon having two digital signatures; and

a security scheme in which the PMD-formatted commands are digitally signed, stored in the secure storage, checked for validity of the digital signature following receipt of the caregiver approval, digitally signed in place of the existing digital signature, and marked for delivery only upon having a second digital signature.

8. A system according to claim 1, further comprising:

an expiration time associated with the PMD-formatted commands, wherein the application of the PMD-formatted commands is conditioned subject to the expiration time.

9. A system according to claim 1, further comprising:

an included timestamp to indicate a time that the PMD was last programmed prior to translation of the programming instructions, wherein the timestamp is included with the PMD-formatted commands; and

a timestamp stored on the PMD to indicate a time that programming was most recently applied to the PMD, wherein the application of the PMD-formatted commands is conditioned subject to the included timestamp matching the stored timestamp.

10. A system according to claim 1, further comprising:

a data entry mechanism to specify the programming instructions using at least one of a Web browser application, a remotely-connectable programmer, and a dedicated application on a personal computer.

11. A system according to claim 1, further comprising:

a patient consent mechanism to confirm the patient consent through at least one of prompting by a programming device, patient-initiated action, prompting by the PMD, and prior patient consent.

12. A system according to claim 1, wherein the application of the PMD-formatted commands is performed in a single programming session, comprising at least one of:

a user interface to prompt for resumption of the programming session in response to an short-duration interruption;

a retry mechanism to automatically resume the programming session after a short duration interruption; and

a recovery mechanism to halt the programming session and to restore earlier PMD-formatted commands to the PMD in response to a long-duration interruption.

13. A system according to claim 1, wherein the PMD comprises at least one of an implantable PMD and an external PMD.

14. A method for remotely programming a patient medical device, comprising:

translating programming instructions specified remotely into commands formatted for a patient medical device (PMD) to control functionality thereof;

checking correctness of the PMD-formatted commands;

confirming patient consent to modify the functionality of the PMD;

controlling application of the PMD-formatted commands to the PMD during a programming session initiated and performed remotely; and

confirming the application of the PMD-formatted commands through interrogation of the PMD to verify the functionality modified.

15. A method according to claim 14, wherein the PMD-formatted commands are applied to the PMD in one of real time or deferred time.

16. A method according to claim 14, further comprising:

limiting the programming instructions to selections corresponding to a subset of all possible commands for the PMD.

17. A method according to claim 14, further comprising:

confirming validity of the PMD-formatted commands as part of the correctness checking, further comprising at least one of;

ensuring the PMD-formatted commands are allowed;

verifying that any values included as part of the PMD-formatted commands are within constrained limits; and

;

performing interactive limit checking of the PMD-formatted commands against existing PMD commands and state.

18. A method according to claim 14, further comprising:

ensuring secure transmittal of the PMD-formatted commands, comprising;

prior to transmittal, digitally signing the PMD-formatted commands; and

following transmittal, confirming an identify of a source of the PMD-formatted commands as legitimate and ensuring that the PMD-formatted commands were not altered during transit.

19. A method according to claim 18, wherein the verifier comprises at least one of a remote programming device and a PMD.

20. A method according to claim 18, further comprising:

receiving caregiver approval of the PMD-formatted commands; and

maintaining a secure storage, further comprising;

providing a security scheme in which the PMD-formatted commands are digitally signed, stored in the secure storage, and marked for delivery only following receipt of the caregiver approval;

providing a security scheme in which the PMD-formatted commands are stored in the secure storage, and digitally signed for delivery only following receipt of caregiver approval;

providing a security scheme in which the PMD-formatted commands are digitally signed, stored in the secure storage, digitally signed again, and marked for delivery only upon having two digital signatures; and

providing a security scheme in which the PMD-formatted commands are digitally signed, stored in the secure storage, checked for validity of the digital signature following receipt of the caregiver approval, digitally signed in place of the existing digital signature, and marked for delivery only upon having a second digital signature.

21. A method according to claim 14, further comprising:

associating an expiration time with the PMD-formatted commands; and

conditioning the application of the PMD-formatted commands subject to the expiration time.

22. A method according to claim 14, further comprising:

including a timestamp with the PMD-formatted commands to indicate a time that the PMD was last programmed prior to translation of the programming instructions;

storing a timestamp on the PMD to indicate a time that programming was most recently applied to the PMD; and

conditioning the application of the PMD-formatted commands subject to the included timestamp matching the stored timestamp.

23. A method according to claim 14, further comprising:

specifying the programming instructions using at least one of a Web browser application, a remotely-connectable programmer, and a dedicated application on a personal computer.

24. A method according to claim 14, further comprising:

confirming the patient consent through at least one of prompting by a programming device, patient-initiated action, prompting by the PMD, and prior patient consent.

25. A method according to claim 14, further comprising:

performing the application of the PMD-formatted commands in a single programming session, comprising at least one of;

prompting for resumption of the programming session in response to an short-duration interruption;

automatically resuming the programming session after a short-duration interruption; and

a retry mechanism to automatically resume the programming session after a short duration interruption

halting the programming session and restoring earlier PMD-formatted commands to the PMD in response to a long-duration interruption.

26. A method according to claim 14, wherein the PMD comprises at least one of an implantable PMD and an external PMD.

27. A computer-readable storage medium holding code for performing the method according to claim 14.

28. An apparatus for remotely programming a patient medical device, comprising:

means for translating programming instructions specified remotely into commands formatted for a patient medical device (PMD) to control functionality thereof;

means for checking correctness of the PMD-formatted commands;

means for confirming patient consent to modify the functionality of the PMD;

means for controlling application of the PMD-formatted commands to the PMD during a programming session initiated and performed remotely; and

means for confirming the application of the PMD-formatted commands through interrogation of the PMD to verify the functionality modified.