System and method for remotely programming a patient medical device

• US 8,798,760 B2
• Filed: 11/06/2013
• Issued: 08/05/2014
• 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 P., Franke, Karen, Jelatis, George D.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US14/073,495
• Publication Number:
  US 20140055230A1
• Time in Patent Office: 272 Days
• Field of Search: 607/30, 607/31, 607/59
• US Class Current: 607/59
• 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 (PMD), comprising:

a non-regulated user interface configured to receive caregiver-selected programming instructions, wherein the non-regulated user interface is configured to limit the selection of programming instructions to a subset of all possible PMD instructions that are appropriate for programming remotely;

a regulated device configured to translate the caregiver-selected programming instructions specified remotely at the non-regulated user interface into commands formatted for the patient medical device to control functionality thereof, and to check correctness of the PMD-formatted commands;

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

a remote programming device configured to control application of the PMD-formatted commands to the PMD during a programming session initiated and performed remotely, wherein the remote programming device confirms application of the PMD-formatted commands 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 deferred time and real time.

3. A system according to claim 1, wherein the regulated device is configured to confirm validity of the PMD-formatted commands as part of the correctness checking by performing at least one of the checks selected from the group consisting of:

ensuring that the PMD-formatted commands are allowed;

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

checking the PMD-formatted commands against existing PMD commands and PMD state for any interactive limits.

4. A system according to claim 1, a security infrastructure configured to ensure transmittal of the PMD-formatted commands, comprising:

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

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

5. A system according to claim 4, wherein the verifier comprises at least one selected from the group consisting of:

the remote programming device and the PMD.

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

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

a secure storage, configured to store PMD-formatted commands-having a disposition selected from the group consisting of;

a first disposition in which the PMD-formatted commands are digitally signed, stored in the secure storage, and configured to be marked for delivery only following receipt of the caregiver approval;

a second disposition-in which the PMD-formatted commands are configured to be digitally signed for delivery only following receipt of caregiver approval;

a third disposition-in which the PMD-formatted commands are digitally signed, and configured to be digitally signed again, and further configured to be marked for delivery only upon having two digital signatures; and

a fourth disposition-in which the PMD-formatted commands are digitally signed, configured to be checked for validity of the digital signature following receipt of the caregiver approval, further configured to be digitally signed in place of the existing digital signature, and further configured to be marked for delivery only upon having a second digital signature.

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

an expiration time associated with the PMD-formatted commands, wherein the regulated device is configured to apply the expiration time to the PMD-formatted commands.

8. 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.

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

a data entry mechanism to specify the programming instructions using at least one selected from the group consisting of;

a Web browser application, a remotely-connectable programmer, and a dedicated application on a personal computer.

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

a patient consent mechanism to confirm the patient consent through at least one selected from the group consisting of;

prompting by a programming device, patient-initiated action, prompting by the PMD, and prior patient consent.

11. 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 selected from the group consisting 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.

12. A system according to claim 1, wherein the PMD comprises at least one selected from the group consisting of:

an implantable PMD and an external PMD.

13. A method for remotely programming a patient medical device (PMD), comprising:

receiving caregiver-selected programming instructions at a non-regulated user interface, wherein the non-regulated user interface limits the selection of programming instructions to a subset of all possible PMD instructions that are appropriate for programming remotely;

translating by a regulated device caregiver-selected programming instructions specified remotely at the non-regulated user interface into commands formatted for the patient medical device to control functionality thereof;

checking correctness of the PMD-formatted commands;

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

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.

14. A method according to claim 13, wherein the PMD-formatted commands are applied to the PMD in one of real time or deferred time.

15. A method according to claim 13, further comprising:

confirming validity of the PMD-formatted commands as part of the correctness checking, further comprising at least one selected from the group consisting 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.

16. A method according to claim 13, 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.

17. A method according to claim 13, further comprising:

receiving caregiver approval of the PMD-formatted commands; and

maintaining a secure storage, further comprising at least one of the elements selected from the group consisting of;

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.

18. A method according to claim 13, 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.

19. A non-transitory computer-readable storage medium holding code for performing the method according to claim 13.

20. An apparatus for remotely programming a patient medical device (PMD), comprising:

means for receiving caregiver-selected programming instructions at a non-regulated user interface, wherein the non-regulated user interface is configured to limit the selection of programming instructions to a subset of all possible PMD instructions that are appropriate for programming remotely;

means for translating by a regulated device the caregiver-selected programming instructions specified remotely at the non-regulated user interface into commands formatted for the patient medical device to control functionality thereof;

means for checking correctness of the PMD-formatted commands;

means for digitally signing the PMD-formatted commands prior to transmittal;

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.