Fail-safe programming for implantable medical device

• US 8,068,917 B2
• Filed: 08/29/2003
• Issued: 11/29/2011
• Est. Priority Date: 08/29/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Petersen, Christopher M., Willenbring, James E.
• Primary Examiner(s): Kahelin; Michael
• Application Number:
  US10/650,946
• Publication Number:
  US 20050049656A1
• Time in Patent Office: 3,014 Days
• Field of Search: 607/60, 607/31
• US Class Current: 607/60
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• 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 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

In general, the invention is directed to a system with a fail-safe mode for remote programming of medical devices, such as implantable medical devices (IMDs). During a remote programming session, an adverse event, such as a programming session failure, may prevent proper completion of a programming or result in improper programming due to data corruption or other factors. If a programming session is not completed correctly, the IMD is susceptible to improper operation, possibly exposing a patient to delivery of unnecessary or inappropriate therapies. A fail-safe mode reduces the likelihood of improper operation following a programming session failure. The fail-safe mode defines one or more fail-safe operations designed to preserve proper operation of the IMD. In some embodiments, the fail-safe operations include notifying a person concerning the failure of the programming session, modifying programming parameters within the implantable medical device, and delivering a therapy to a patient.

Claims

1. A method comprising:

initiating a remote programming session within an implantable medical device over a long-range telecommunication link, the remote programming session comprising providing signals from a programming device separate and remote from the implantable medical device to program the implantable medical device with operating parameters defining operation of the implantable medical device, the remote programming device being at a site located a significant distance from the implantable medical device;

in the event the remote programming session succeeds, operating the implantable medical device according to the operating parameters following the remote programming session; and

invoking a fail-safe operation in the event the remote programming session fails, wherein invoking the fail-safe operation includes automatically modifying the operating parameters of the implantable medical device and operating the implantable medical device according to the modified operating parameters following the failed remote programming session.

2. The method of claim 1, wherein invoking the fail-safe operation includes notifying a person concerning the failure of the programming session.

3. The method of claim 2, wherein notifying a person includes generating an alarm from within the implantable medical device.

4. The method of claim 3, wherein generating an alarm from within the implantable medical device comprises generating one of a vibration and a sound.

5. The method of claim 2, wherein notifying a person comprises sending an electronic message to the person.

6. The method of claim 5, wherein the electronic message includes one of a short messaging service (SMS) message, an instant messenger message, an email, an audible alert on a remote programmer, a visual alert on a remote programmer, an audible alert on a wireless device, and a visual alert on a wireless device.

7. The method of claim 1, wherein modifying the operating parameters includes waiting for a delay period following the failed programming session before modifying the operating parameters.

8. The method of claim 1, wherein operating the implantable medical device according to the modified operating parameters comprises delivering a therapy to a patient based on the modified operating parameters via one of an automated external defibrillator (AED), a drug pump, a neurostimulator, and the implantable medical device.

9. The method of claim 1, wherein the implantable medical device includes one of a cardiac pacemaker, a neurostimulator, and a drug pump.

10. The method of claim 1, wherein providing signals from a programming device separate and remote from the implantable medical device to program the implantable medical device comprises:

transmitting first signals from the remote programming device to a local programmer; and

transmitting second signals from the local programmer to the implantable medical device.

11. The method of claim 10, wherein the first signals are transmitted via the Internet.

12. The method of claim 1, wherein modifying the operating parameters comprises reverting to default operating parameters.

13. The method of claim 1, wherein modifying the operating parameters comprises restoring a previous operating parameter setting.

14. The method of claim 1, wherein operating the implantable medical device according to the first operating parameters comprises delivering therapy to the patient according to the first operating parameters.

15. The method of claim 1, wherein operating the implantable medical device according to the first operating parameters comprises monitoring one or more patient parameters according to the first operating parameters.