Implantable device failsafe mode for MRI

• US 8,538,550 B2
• Filed: 12/22/2010
• Issued: 09/17/2013
• Est. Priority Date: 12/29/2009
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Stubbs, Scott R., Bocek, Joseph M., Doshi, Hiten J.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US12/976,876
• Publication Number:
  US 20110160786A1
• Time in Patent Office: 1,000 Days
• Field of Search: 607/4, 607/31, 607/60, 607/63
• US Class Current: 607/63
• CPC Class Codes: A61N 1/3688 configured for switching the pacing mode, e.g. from AAI to DDD
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/3718 Monitoring of or protection against external electromagnetic fields or currents

Abstract

An implantable device, such as a pacer, defibrillator, or other cardiac rhythm management device, can include a failsafe backup, such as a separate and independent safety core that can assume control over operation of the implantable device from a primary controller. In an example, the safety core can include a normal first safety core operating mode and a magnetic resonance imaging (MRI) second safety core operating mode that can provide different functionality from the normal first safety core operating mode.

Claims

1. An apparatus comprising:

an implantable medical device, comprising;

a primary controller circuit;

a safety core circuit, separate from the primary controller circuit, the safety core circuit configured to operate independently from the primary controller circuit;

a safety core operating mode storage circuit, coupled to the safety core circuit, the safety core operating mode storage circuit configured to store safety core operating mode information to control whether the safety core circuit is configured to operate in a normal first safety core operating mode or to operate in a magnetic resonance imaging (MRI) second safety core operating mode that is associated with different functionality than the first safety core operating mode; and

a reset controller circuit, coupled to the primary controller circuit and the safety core circuit, the reset controller circuit configured to transition control of operating the implantable medical device from the primary controller circuit to the safety core circuit when a fault or error condition is detected.

2. The apparatus of claim 1, comprising an MRI detector circuit, coupled to the safety core operating mode storage circuit, and wherein the safety core operating mode storage circuit is configured to select the safety core operating mode in response to whether the MRI detector circuit detects that an MRI apparatus is or could be present or in use nearby the implantable medical device.

3. The apparatus of claim 1, wherein the normal first safety core operating mode includes heart contraction sensing turned on or enabled and the MRI second safety core operating mode includes heart contraction sensing turned off or disabled.

4. The apparatus of claim 3, wherein the normal first safety core operating mode includes anti-tachyarrhythmia shock therapy turned on or enabled and the MRI second safety core operating mode includes anti-tachyarrhythmia shock therapy turned off or disabled.

5. The apparatus of claim 1, wherein the normal first safety core operating mode is configured to provide unipolar pacing and the MRI second safety core operating mode is configured to provide bipolar pacing.

6. The apparatus of claim 5, wherein the normal first safety core operating mode is configured to provide bi-ventricular pacing and the MRI second safety core operating mode is configured to provide single-ventricle pacing.

7. The apparatus of claim 6, wherein the normal first safety core operating mode is configured to provide intrinsic heart contraction sensing and to provide pacing in a mode that inhibits a pace when an intrinsic heart contraction is sensed, and wherein the MRI second safety core operating mode is configured with intrinsic heart contraction sensing turned off or disabled and is configured to provide pacing in an asynchronous mode that paces without regard to whether an intrinsic heart contraction is present.

8. The apparatus of claim 1, wherein the normal first safety core operating mode is configured to provide bi-ventricular pacing and the MRI second safety core operating mode is configured to provide single-ventricle pacing.

9. The apparatus of claim 1, wherein the normal first safety core operating mode is configured to provide intrinsic heart contraction sensing and to provide pacing in a mode that inhibits a pace when an intrinsic heart contraction is sensed, and wherein the MRI second safety core operating mode is configured with intrinsic heart contraction sensing turned off or disabled and is configured to provide pacing in an asynchronous mode that paces without regard to whether an intrinsic heart contraction is present.

10. The apparatus of claim 1, comprising:

a primary controller operating mode storage circuit, coupled to the primary controller circuit, the primary controller operating mode storage circuit configured to store primary controller operating mode information to control whether the primary controller circuit is configured to operate in a normal first primary controller operating mode or to operate in a magnetic resonance imaging (MRI) second primary controller operating mode that is associated with different functionality than the first primary controller operating mode; and

wherein the safety core operating mode storage circuit is configured to return the safety core operating mode to the normal first safety core operating mode when the primary controller operating mode storage circuit returns the primary controller operating mode to the normal first primary controller operating mode.

11. A method comprising:

operating an implantable medical device under control of a primary controller circuit to provide a diagnostic or therapy to a subject;

detecting a fault or error condition in the implantable medical device; and

in response to the detected fault or error condition, automatically transitioning operation of the implantable medical device from control by the primary controller circuit to control by a safety core circuit, separate from the primary controller circuit, the safety core circuit configured to operate independently from the primary controller circuit, the safety core circuit configured to include a normal first operating mode and an MRI second operating mode that is associated with different functionality than the first operating mode.

12. The method of claim 11, comprising:

detecting that an MRI device is indicated to be present near the implantable medical device;

in response to detecting that the MRI device is indicated to be present, operating the implantable medical device under control of the back-up circuit in the MRI second operating mode.

13. The method of claim 11, wherein detecting that an MRI device is indicated to be present comprises detecting electromagnetic energy associated with the MRI device.

14. The method of claim 11, wherein detecting that an MRI device is indicated to be present comprises detecting a user-programmed indication that is associated with an MRI procedure to be performed on the patient.

15. The method of claim 11, wherein the normal first operating mode includes heart contraction sensing turned on or enabled and the MRI second operating mode includes heart contraction sensing turned off or disabled.

16. The method of claim 15, wherein the normal first operating mode includes anti-tachyarrhythmia shock therapy turned on or enabled and the MRI second operating mode includes anti-tachyarrhythmia shock therapy turned off or disabled.

17. The method of claim 11, wherein the normal first operating mode is configured to provide unipolar pacing and the MRI second operating mode is configured to provide bipolar pacing.

18. The method of claim 11, wherein the normal first operating mode is configured to provide bi-ventricular pacing and the MRI second operating mode is configured to provide single-ventricle pacing.

19. The method of claim 18, wherein the normal first operating mode is configured to provide intrinsic heart contraction sensing and to provide pacing in a mode that inhibits a pace when an intrinsic heart contraction is sensed, and wherein the MRI second operating mode is configured with intrinsic heart contraction sensing turned off or disabled and is configured to provide pacing in an asynchronous mode that paces without regard to whether an intrinsic heart contraction is present.

20. The method of claim 11, comprising returning the safety core operating mode to the normal first operating mode upon returning a primary controller operating mode from a MRI second primary controller operating mode to a normal first primary controller operating mode.