SYSTEMS AND METHODS FOR PROVIDING ARRHYTHMIA THERAPY IN MRI ENVIRONMENTS

• US 20100211123A1
• Filed: 12/16/2009
• Published: 08/19/2010
• Est. Priority Date: 02/19/2009
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Gilkerson, James O., Stubbs, Scott R., Schuster, Diane
• Granted Patent: US 8,639,331 B2
• Time in Patent Office: Days
• US Class Current: 607/4
• 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
• CPC Class Codes: A61N 1/3931 Protecting, e.g. back-up systems

Abstract

Systems and methods for arrhythmia therapy in MRI environments are disclosed. Various systems disclosed utilize ATP therapy rather than ventricular shocks when patients are subjected to electromagnetic fields in an MRI scanner bore and shock therapy is not available. As the patient is moved out from within the scanner bore and away from the MRI scanner, the magnetic fields diminish in strength eventually allowing a high voltage capacitor within the IMD to charge if necessary. The system may detect when the electromagnetic fields no longer interfere with the shock therapy and will transition the IMD back to a normal operational mode where shock therapy can be delivered. Then, if the arrhythmia still exists, the system will carry out all of the system'"'"'s prescribed operations, including the delivery of electric shocks to treat the arrhythmia.

Claims

1. A method for operating an implantable medical device (IMD) implanted within a patient in the presence of a magnetic resonance imaging (MRI) environment, the method comprising:

receiving a command while the IMD is in the presence of an MRI electromagnetic field and is operating in a first operational mode in which one or more sensors of the IMD have been disabled, the command configured to prompt the IMD to provide immediate therapy to the patient while in the MRI electromagnetic field; and

placing the IMD in a second operational mode upon receiving the command, wherein the second operational mode includes;

enabling the one or more sensors of the IMD;

determining whether a tachyarrhythmia is present using the one or more sensors; and

delivering antitachycardia pacing (ATP) therapy to the patient if a tachyarrhythmia is determined to be present.

2. The method of claim 1, wherein the second operational mode further comprises:

determining if the ATP therapy has been exhausted and if the tachyarrhythmia is still present; and

delivering additional ATP therapy if the ATP therapy has not been exhausted and the tachyarrhythmia is determined to still be present.

3. The method of claim 1, further comprising:

monitoring for a core saturation signal that indicates the absence or presence of an MRI electromagnetic field that would result in an inability of the IMD to deliver tachyarrhythmia shock therapy; and

placing the IMD in a third operational mode when the core saturation signal being monitored indicates the absence of the MRI electromagnetic field, wherein in the third operational mode the IMD is configured to determine if ATP therapy or shock therapy is needed and to deliver the ATP therapy or shock therapy when a determination is made that ATP therapy or shock therapy is needed.

4. The method of claim 1, further comprising:

monitoring a core saturation signal that indicates the absence of external magnetic fields that would interfere with tachyarrhythmia therapy delivered by the IMD;

if the core saturation signal indicates the absence of the external magnetic fields, placing the IMD in a third operational mode to deliver tachyarrhythmia therapy.

5. The method of claim 1, wherein the ATP therapy provides pacing at programmed intervals.

6. The method of claim 5, wherein providing ATP therapy at programmed intervals includes providing higher pacing rates in earlier programmed intervals and lower pacing rates in one or more subsequent intervals.

7. The method of claim 5, wherein the ATP therapy terminates after two or more programmed intervals.

8. The method of claim 1, wherein the IMD delivers no ATP therapy to the patient if a tachyarrhythmia is not sensed by the one or more sensors.

9. The method of claim 1, wherein the command is received from an operator via an external device.

10. The method of claim 1, wherein the one or more sensors have been disabled by either deactivating the one or more sensors or the output from the one or more sensors is being ignored by the IMD, and wherein enabling the one or more sensors of the IMD includes activating a deactivated sensor or monitoring the output from the one or more sensors that is being ignored.

11. An implantable medical device (IMD) configured for implantation in a patient to monitor cardiac activity in, and deliver therapy to, the patient'"'"'s heart, the IMD comprising:

a pulse generator operable to deliver pacing pulses and shock pulses;

at least one lead having a proximal section coupled to the pulse generator and a distal section secured to the patient'"'"'s heart, wherein the at least one lead is configured to deliver a therapeutic stimulus to the patient'"'"'s heart; and

a state control module operable to place the IMD in one of a plurality of operational modes including operational modes for operation of the IMD in the presence of an MRI electromagnetic field, wherein the operational modes include a first operational mode where the IMD monitors for a command indicating the need for immediate therapy, a second operational mode that activates one or more sensors to be used in determining the presence of a tachyarrhythmia, and a third operational mode to deliver pacing pulses until the tachyarrhythmia is no longer present or until a fixed number of pacing sessions have been exhausted.

12. The IMD of claim 11, further comprising a communication module operable to receive mode commands from a device external to the patient, wherein the mode commands prompt the IMD to enter into one of the plurality of operational modes.

13. The IMD of claim 12, wherein the communication module includes circuitry for communicating wirelessly with the device external to the patient.

14. The IMD of claim 11, wherein in the first operational mode the IMD is configured to not deliver pacing pulses or shock pulses.

15. The IMD of claim 11, wherein the state control module is operable to place the IMD in a fourth operational mode for monitoring for tachyarrythmia and selectively delivering pacing pulses or shocks.

16. The IMD of claim 15, wherein the IMD includes a communication module to receive and process command signals from an external device, and wherein the IMD will transition from the fourth operational mode and to the first operational mode after a first operational mode command signal is received.

17. The IMD of claim 15, wherein the IMD further includes an MRI detection module configured to automatically detect the presence of an MRI electromagnetic field, and wherein, in response to the detection of the MRI electromagnetic field, the state control module is configured to place the IMD in the first operational mode.

18. The IMD of claim 11, wherein, in the third operational mode, the IMD is configured to deliver pacing pulses up to a fixed number of pacing sessions.

19. A method of operating an implantable medical device (IMD) in the presence of a magnetic resonance imaging (MRI) environment, the method comprising:

monitoring for an MRI signal indicating the presence of an MRI electromagnetic field;

entering a first operational mode when the MRI signal is detected, wherein upon entering the first operational mode of the IMD at least one sensor input to the IMD is ignored and no pacing therapy or shock therapy is delivered to a patient'"'"'s heart;

monitoring for a command signal from an external device indicating the need for immediate therapy;

transitioning the IMD into a second operational mode upon detecting the command signal, wherein the at least one sensor input of the IMD is monitored to determine if a tachyarrhythmia exists; and

delivering pacing therapy to the patient if a tachyarrhythmia is determined to be present while in the presence of the MRI electromagnetic field.

20. The method of claim 19, wherein the MRI signal is received from an external device.

21. The method of claim 19, wherein upon entering into the second operational mode, the method further comprises:

monitoring for a core saturation signal which indicates a continued presence of the MRI electromagnetic field; and

wherein delivering pacing therapy to the patient includes delivering up to a fixed number of antitachycardia pacing (ATP) therapy sessions if the tachyarrhythmia is determined to exist and the core saturation signal indicates the presence of the MRI electromagnetic field.

22. The method of claim 21, wherein once the core saturation signal indicates an absence of the MRI electromagnetic field, the method further comprises entering a third operational mode that allows the IMD to provide shock therapy to the patient.