Command sequencing and interlocks for a remotely programmable implantable device

• US 7,460,910 B2
• Filed: 07/20/2005
• Issued: 12/02/2008
• Est. Priority Date: 07/20/2004
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Webb, James David
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/187,352
• Publication Number:
  US 20060074465A1
• Time in Patent Office: 1,231 Days
• Field of Search: 607/30, 607/31, 705/3
• US Class Current: 607/30
• 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 care provider 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 (IRM), the server storing safety parameter data related to the IMD, 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;

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;

comparing the instruction to the safety parameter data stored on server; and

providing a notice to the care provider if the instructions are inconsistent with the stored safety parameter data.

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.

10. The method of claim 1 wherein the IRM stores safety parameter data related to the IMD, and wherein the method further comprises the steps of:

comparing the instruction to the safety parameter data stored on the IRM; and

canceling the instructions if the instructions are inconsistent with the safety parameter data stored on the IRM.

9. A server system for use in conjunction with a browser application operable by a care provider, a medical device (IMD), and a monitor (IRM) permitting communication between the server system and the IMD, the server system comprising:

a processor; and

a digital storage medium, the digital storage medium having computer-executable instructions stored thereon instructing the processor to;

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

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

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

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

forward 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;

compare the instruction to the safety parameter data stored on server system; and

provide a notice to the care provider if the instructions are inconsistent with the stored safety parameter data.