Command sequencing and interlocks for a remotely programmable implantable device

• US 20060074465A1
• Filed: 07/20/2005
• Published: 04/06/2006
• Est. Priority Date: 07/20/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Webb, James David
• Granted Patent: US 7,460,910 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A care provider is able to remotely program a pacemaker, drug pump, neurostimulation device or other an implantable medical device (IMD) by operating a browser application communicating with a server. Following successful authentication to the server, the care provider'"'"'s browser receives information about one or more operating parameters of the IMD from the server. The care provider provides an instruction from the browser application to the server to modify one or more operating parameters. The server formats a digital program request from the instruction that includes a digital signature or other identification code uniquely identifying the server. The digital program request is then forwarded to the IMD via a remote monitor (IRM) for subsequent verification of the digital identification code and wireless transmission the verified digital program request from the IRM to the IMD.

Claims

1. A method for allowing a caregiver operating a browser application communicating with a server to modify an operating parameter of a medical device (IMD) implanted in a patient, the IMD communicating with the server via a monitor (IR), the method comprising the steps of:

processing an access request received from the browser application at the server to authenticate the care provider;

if authentication of the care provider is successful, providing information about the operating parameter from the server to the browser application;

receiving an instruction at the server from the browser application to modify the operating parameter;

formatting a digital program request from the instruction at the server, the program request comprising a digital identification code uniquely identifying the server; and

forwarding the digital program request to the IRM for subsequent verification of the digital identification code and wireless transmission of the verified digital program request to the IMD.

2. The method of claim 1 wherein the formatting step comprises assigning a sequential code to the digital program request, and wherein the IRM is operable to compare the sequential code to a second sequential code earlier received by the IMD to verify that the digital program request is not received out-of-order.

3. The method of claim 1 further comprising the step of queuing the digital program request until a request for connection is received from the IRM.

4. The method of claim 3 further comprising the steps of comparing an IMD identifier contained within the request for connection to a previously-stored identifier for the IMD prior to forwarding the digital program request to the IRM.

5. The method of claim 1 wherein the access request comprises at least one digital credential uniquely associated with the care provider, wherein the digital credential is selected from the group consisting of a digital signature, a biometric identifier, and an identifier provided by a digital token.

6. The method of claim 1 further comprising the step of receiving an update message from the IRM, the update message comprising an indication of the successful delivery of the digital program request.

7. The method of claim 1 wherein the operating parameter comprises at least one of the group consisting of an allowed dose, an allowed dose interval, an allowed activation dose, and an allowed activation dose interval.

8. The method of claim 1 further comprising the step of updating the information about the operating parameter provided to the care provider in response to the instruction.

9. The method of claim 1 further comprising the step of evaluating the instructions based upon safety criteria, and providing a notice to the care provider if the instructions violate the safety criteria.

10. A server system comprising a processor and a digital storage medium, the digital storage medium having computer-executable instructions stored thereon that are configured to execute the method of claim 1.

11. A method of providing a digital program request formatted by a remotely-located server to an implantable medical device (IMD) having an identifier associated therewith, the method comprising the steps of:

providing the identifier to the remotely-located server to acquire the digital program request intended for the IMD;

validating the digital program request using a digital identification code uniquely identifying the server;

in response to successful validation of the digital program request, adding the program request to a storage queue associated with the IMD for subsequent wireless transmission to the IMD; and

storing a result of the validating step in a notification queue for subsequent transmittal to the server.

12. The method of claim 11 wherein the validating step comprises comparing compare a sequential code contained within the digital program request to a second sequential code earlier processed by the IMD to verify that the digital program request is not processed out-of-order.

13. The method of claim 11 wherein the digital program request is one of a plurality of program requests intended for the IMD, each of the plurality of program requests associated with a sequential code assigned by the server.

14. The method of claim 13 wherein at least one of the plurality of program requests is a cancellation request having a sequential code that is greater than the sequential code assigned to a previous program request, and wherein the method further comprises the step of canceling the previous program request following successful validation of the cancellation request.

15. The method of claim 13 wherein the method comprises repeating the validating, adding and storing steps for each of the plurality of program requests.

16. The method of claim 11 wherein the providing step comprises synchronizing a clock to a system clock present on the server.

17. The method of claim 11 further comprising the step of determining a proper value of an operating parameter for the IMD based at least in part upon information contained in the program request and information received from the IMD.

18. The method of claim 11 further comprising the steps of:

establishing a wireless connection to the IMD;

further validating the program request in the storage queue using the digital identification code uniquely identifying the server and the identifier associated with the IMD;

upon successful validation, transferring the program request to the IMD via the wireless connection; and

storing the results of the further validation step in the notification queue for subsequent transmittal to the server.

19. A remote monitoring device comprising a processor and a digital storage medium, the digital storage medium having executable instructions stored thereon that are configured to execute the method of claim 11.

20. A remote monitoring device for facilitating communication between a server and an implantable medical device (IMD) having an identifier associated therewith, the remote monitoring device comprising:

a wireless interface configured to communicate with the IMD;

a network interface configured to communicate with the server; and

a processor configured to execute a software application, the software application configured to obtain the identifier from the IMD via the wireless interface, to provide the identifier to the server via the network interface to acquire the digital program request intended for the IMD, to validate a digital identification code uniquely identifying the server-contained within the digital program request, to add the validated program request to a storage queue associated with the IMD for subsequent wireless transmission to the IMD via the wireless interface, and to store responses to the server in a notification queue for subsequent transmittal to the server via the network interface.