Integrated system and method for MRI-safe implantable devices

• US 8,874,228 B2
• Filed: 07/27/2005
• Issued: 10/28/2014
• Est. Priority Date: 07/27/2004
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Lowe, Mark Joseph, Phillips, Michael D.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US11/190,779
• Publication Number:
  US 20060025820A1
• Time in Patent Office: 3,380 Days
• Field of Search: 607/62
• US Class Current: 607/62
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61N 1/37 Monitoring; Protecting

Abstract

An implantable system includes at least one electrode that is configured to apply a stimulus to surrounding tissue based on a control signal. A control module provides the control signal, such as for controlling application of the stimulus, which can be an electrical stimulus, a chemical stimulus or a combination thereof. A detector is configured to detect a temperature characteristic associated with one or more of the electrode and the surrounding tissue. An output signal is provided based on the detected temperature characteristic. The output signal can be used by an associated diagnostic system to terminate a diagnostic procedure, such as to mitigate heating of the electrode and/or the surrounding tissue.

Claims

1. An implantable system, comprising:

a lead system comprising a body portion and at least one electrode attached to the body portion, the lead system being configured for implantation in a patient;

a transducer operably connected with the lead system, the transducer being operative to provide a transducer signal that varies as a function of a temperature characteristic of surrounding tissue;

an integrated implantable module communicatively connected with the lead system via an extension, the module comprising;

a signal generator that provides at least one electrical signal to the at least one electrode via the extension; and

a detector configured to provide a detector signal indicative of the temperature of the surrounding tissue based on the transducer signal; and

an interface configured to communicatively couple the integrated implantable module with a diagnostic system that is located external to the integrated implantable module via a communications link, wherein the diagnostic system is a Magnetic Resonance Imaging (MRI) system.

2. The implantable system of claim 1, further comprising a control system configured to control the signal generator to provide the at least one electrical signal, the control system also providing an output signal in response to determining that the temperature characteristic exceeds a temperature threshold based on the detector signal.

3. The implantable system of claim 2, wherein the temperature threshold is programmable.

4. The implantable system of claim 1, wherein the transducer comprises a thermocouple located adjacent a distal end of the of the body portion.

5. The implantable system of claim 1, wherein the detector further comprises:

a comparator that provides a first comparator signal based on comparison of the indication of a temperature characteristic relative to a predetermined threshold;

a second comparator that provides a second comparator signal based on comparison of a rate of change in temperature associated with at least one of the at least one electrode and the surrounding tissue relative to a predetermined temperature threshold, the rate of change in temperature being determined as a function of the indication of a temperature characteristic provided by the detector; and

the integrated implantable module providing an output signal based on at least one of the first comparator signal and the second comparator signal.

6. An implantable system, comprising:

a lead system comprising a body portion and at least one electrode attached to the body portion;

a transducer operably connected with the lead system, the transducer being operative to provide a transducer signal that varies as a function of a temperature characteristic of surrounding tissue;

an integrated module communicatively connected with the lead system via an extension, the module comprising;

a signal generator that provides at least one electrical signal to the at least one electrode via the extension; and

a detector configured to provide a detector signal indicative of the temperature of the surrounding tissue based on the transducer signal; and

an interface configured to communicatively couple the integrated module with a diagnostic system that is located external to the integrated module via a communications link, the diagnostic system terminating at least application of radiofrequency pulses in response to a signal received via the communications link indicating that the temperature characteristic exceeds a temperature threshold.

7. The implantable system of claim 6, wherein the communications link comprises one of an electrically conductive link, a wireless link and an optical link.

8. An implantable system, comprising:

a lead system that includes at least one electrode operatively connected to an elongate body portion of the lead system, the at least one electrode configured to apply a stimulus to surrounding tissue based on a control signal;

an implantable control module that provides the control signal;

an extension that electrically connects the at least one electrode of the lead system with the implantable control module; and

an implantable transducer connected with the lead system, the implantable transducer being communicatively coupled with the implantable control module and configured for sensing temperature characteristics associated with the surrounding tissue and providing a temperature signal that varies as a function of the sensed temperature of the surrounding tissue,

the implantable control module detecting a temperature characteristic of the surrounding tissue and providing an output signal based on the temperature signal, the output signal being provided to a diagnostic system that is located external to the implantable control module; and

an interface configured to communicatively couple the implantable control module with the diagnostic system via a communications link, the diagnostic system controlling at least application of radiofrequency pulses based the output signal provided by the implantable control module indicating that the temperature characteristic exceeds a temperature threshold.

9. The implantable system of claim 8, wherein the implantable transducer is located adjacent a distal end of the of the elongate body portion.

10. The implantable system of claim 8, wherein the implantable transducer comprises a thermocouple.

11. The implantable system of claim 8, wherein the communications link comprises one of an electrically conductive link, a wireless link and an optical link.

12. The implantable system of claim 8, wherein the implantable control module further comprises:

a comparator that provides a first comparator signal based on comparison of an average indication of detected temperature associated with at least one of the at least one electrode and the surrounding tissue relative to a predetermined temperature threshold; and

output circuitry that provides the output signal based on the first comparator signal.

13. An implantable system, comprising:

a lead system comprising a body portion and at least one electrode attached to the body portion, the lead system being configured for implantation in a patient;

a transducer connected with the lead system, the transducer being operative to provide a transducer signal that varies as a function of temperature of a surrounding tissue environment;

an integrated implantable module communicatively connected with the lead system, the module comprising;

a signal generator that provides at least one electrical signal to the at least one electrode;

a detector configured to provide a detector signal indicative of the temperature characteristic based on the transducer signal; and

a control system configured to control the signal generator to provide the at least one electrical signal, the control system also providing an output signal to an imaging system that is external to the integrated implantable module in response to determining that the temperature characteristic of the surrounding tissue environment exceeds a temperature threshold based on the detector signal.

14. The implantable system of claim 13, further comprising an interface configured to communicatively couple the integrated implantable module with the imaging system via a communications link, the imaging system terminating at least application of radiofrequency pulses based on the output signal provided by the control module indicating that the temperature characteristic exceeds the temperature threshold.

15. The implantable system of claim 13, wherein the temperature threshold is programmable.

16. The implantable system of claim 13, wherein the detector further comprises:

a comparator that provides a first comparator signal based on comparison of an average indication of detected temperature associated with at least one of the at least one electrode and the surrounding tissue relative to a predetermined temperature threshold; and

output circuitry that provides the output signal based on the first comparator signal.

17. An implantable system, comprising:

a lead system comprising a body portion and at least one electrode attached to the body portion;

a transducer operably connected with the lead system, the transducer being operative to provide a transducer signal that varies as a function of a temperature characteristic associated with at least one of the lead system, the at least one electrode and surrounding tissue;

an integrated module communicatively connected with the lead system via an extension, the module comprising;

a signal generator that provides at least one electrical signal to the at least one electrode via the extension; and

a detector configured to provide a detector signal indicative of the temperature characteristic based on the transducer signal, wherein the detector is configured to receive an enable signal from the diagnostic system via the communication link to enable operation of the detector; and

an interface configured to communicatively couple the integrated module with a diagnostic system via a communications link, the diagnostic system terminating at least application of radiofrequency pulses in response to a signal received via the communications link indicating that the temperature characteristic exceeds a temperature threshold.

18. The implantable system of claim 17, wherein the enable signal is provided by the diagnostic system to synchronize operation of the detector with operation of the diagnostic system.