Systems and methods for providing arrhythmia therapy in MRI environments

• US 8,977,356 B2
• Filed: 01/23/2014
• Issued: 03/10/2015
• 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: Stubbs, Scott R., Gilkerson, James O., Schuster, Diane
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US14/162,543
• Publication Number:
  US 20140135861A1
• Time in Patent Office: 411 Days
• Field of Search: 607/4, 607/11, 607/15
• US Class Current: 607/15
• 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 therapy command from an external device 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 therapy command configured to prompt the IMD to provide immediate therapy to the patient while in the MRI electromagnetic field, the therapy command transmitted from the external device to the IMD via telemetry that is different from the MRI electromagnetic field; and

placing the IMD in a second operational mode upon receiving the therapy command,

wherein the second operational mode includes;

enabling the one or more sensors of the IMD;

determining whether an arrhythmia is present using the one or more sensors; and

delivering a first therapy to the patient if the arrhythmia is determined to be present, wherein a second therapy is not delivered by the IMD when in the second operational mode if the arrhythmia is determined to be present while the IMD is in the presence of the MRI electromagnetic field.

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

determining if the first therapy has been exhausted and if the arrhythmia is still present; and

delivering a further regimen of the first therapy if the first therapy has not been exhausted and the arrhythmia 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 the second 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 either the first therapy or the second therapy is needed and to deliver the first therapy or the second therapy when a determination is made that the first therapy or the second 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 the second 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 in which the second therapy is delivered if the arrhythmia is determined to be present.

5. The method of claim 1, wherein the second therapy utilizes a high voltage capacitor, and proper function of the high voltage capacitor is compromised by the MRI electromagnetic field.

6. The method of claim 1, wherein the IMD delivers neither the first therapy nor the second therapy to the patient if the arrhythmia is not sensed by the one or more sensors.

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

8. 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.

9. 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 a first therapy; and

a state control module operable to selectively place the IMD in any of a plurality of operational modes for operation of the IMD in the presence of an MRI electromagnetic field that is strong enough to interfere with operation of the IMD, wherein the IMD is configured to not deliver the second therapy while in the presence of the MRI electromagnetic field and the operational modes include;

a first operational mode where the IMD monitors for a therapy command from an external device indicating the need for immediate therapy, wherein the IMD is configured to not deliver the first therapy while in the first operational mode and the therapy command is received by the IMD from the external device via wireless communication other than the MRI electromagnetic field,

a second operational mode that activates one or more sensors to be used in determining the presence of an arrhythmia, wherein the IMD is configured to enter the second operational mode based on reception of the therapy command while in the first operational mode, and

a third operational mode in which the IMD delivers the first therapy, wherein the IMD is configured to enter the third operational mode based on detecting the presence of the arrhythmia in the second operational mode.

10. The IMD of claim 9, 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 the plurality of operational modes.

11. The IMD of claim 10, wherein the communication module includes circuitry for communicating wirelessly with the device external to the patient.

12. The IMD of claim 9, wherein the state control module is operable to place the IMD in a fourth operational mode while not in the presence of the MRI electromagnetic field, the IMD configured to monitor for the arrhythmia and deliver a second therapy based on detection of the arrhythmia while in the fourth operational mode.

13. The IMD of claim 12, wherein the IMD includes a communication module to receive and process command signals from the external device, and wherein the IMD is configured to transition from the fourth operational mode to the first operational mode after a first operational mode command signal is received.

14. The IMD of claim 12, wherein the IMD further includes an MRI detection module configured to automatically detect the presence of the 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.

15. The IMD of claim 12, wherein the IMD comprises a high voltage capacitor, the second therapy utilizes the high voltage capacitor of the IMD, and proper function of the high voltage capacitor is compromised by the MRI electromagnetic field.

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

monitoring for a signal indicating the presence of a strong MRI electromagnetic field that could interfere with operation of the IMD;

entering a first operational mode when the 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 stimulation therapy is delivered to a patient'"'"'s heart by the IMD;

monitoring for a therapy command signal from an external device indicating the need for immediate therapy while the IMD is still in the presence of the MRI electromagnetic field and in the first operational mode, the therapy command transmitted from the external device to the IMD via wireless communication that is different from the MRI electromagnetic field;

transitioning the IMD into a second operational mode upon detecting the therapy command signal while the IMD is still in the presence of the MRI electromagnetic field, wherein the at least one sensor input of the IMD is monitored to determine if an arrhythmia exists while the IMD is in the second operational mode; and

while the IMD is still in the second operational mode, delivering a first therapy to the patient if the arrhythmia is determined to be present while the IMD is still in the presence of the MRI electromagnetic field, wherein a second therapy is not delivered by the IMD if the arrhythmia is determined to be present while the IMD is still in the presence of the MRI electromagnetic field.

17. The method of claim 16, wherein the MRI signal is received from an external device.

18. The method of claim 16, 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 the first therapy to the patient includes delivering up to a fixed number of therapy sessions if the arrhythmia is determined to exist and the core saturation signal indicates the presence of the MRI electromagnetic field.

19. The method of claim 18, 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 the second therapy to the patient.

20. The method of claim 19, wherein the second therapy utilizes a high voltage capacitor, and proper function of the high voltage capacitor is compromised by the MRI electromagnetic field.