NEURAL STIMULATION SYSTEM ANALYZER

• US 20080281372A1
• Filed: 05/09/2007
• Published: 11/13/2008
• Est. Priority Date: 05/09/2007
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Scheiner, Avram, Libbus, Imad
• Application Number:
  US11/746,263
• Publication Number:
  US 20080281372A1
• Time in Patent Office: Days
• US Class Current: 607/27
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability

Abstract

Various embodiments relate to a device to analyze an implantable neural stimulation system that includes an implantable neural stimulation lead for an implantable neural stimulator to be implanted into a patient. Various device embodiments comprise an external housing, a pacing circuit in the housing, and a sensing circuit in the housing. The pacing circuit is adapted to deliver a test neural stimulation signal. At least one test lead cable is adapted to electrically connect the pacing circuit and the implantable neural stimulation lead to enable the test neural stimulation signal to be delivered to a neural target through the test lead cable and the implantable neural stimulation lead. At least one physiological sensor is adapted to sense a physiological response to stimulation of the neural target. At least one sensor cable is adapted to electrically connect the sensing circuit and the at least one physiological sensor.

Claims

1. A device to analyze an implantable neural stimulation system that includes an implantable neural stimulation lead for an implantable neural stimulator to be implanted into a patient, the device comprising:

an external housing;

a pacing circuit in the housing, the pacing circuit adapted to deliver a test neural stimulation signal;

at least one test lead cable adapted to electrically connect the pacing circuit and the implantable neural stimulation lead to enable the test neural stimulation signal to be delivered to a neural target through the test lead cable and the implantable neural stimulation lead;

a sensing circuit in the housing;

at least one physiological sensor adapted to sense a physiological response to stimulation of the neural target; and

at least one sensor cable adapted to electrically connect the sensing circuit and the at least one physiological sensor.

2. The device of claim 1, wherein the at least one physiological sensor includes a heart rate sensor to sense a heart rate response to stimulation of a vagus nerve.

3. The device of claim 1, wherein the at least one physiological sensor includes a plurality of ECG electrodes to sense a response to stimulation of a vagus nerve.

4. The device of claim 1, further comprising a controller adapted to communicate with the pacing circuit and the sensing circuit to analyze heart rate variability in response to stimulation of the neural target.

5. The device of claim 1, further comprising a controller adapted to communicate with the pacing circuit and the sensing circuit to analyze heart rate turbulence in response to stimulation of the neural target.

6. The device of claim 1, further comprising a display and a controller adapted to communicate with the pacing circuit, the sensing circuit and the display to provide an indication on the display whether the test neural stimulation signal results in a desired physiological response for stimulation of the neural target.

7. The device of claim 1, wherein the test lead cable includes a bipolar cable adapted to connect to a bipolar neural stimulation lead.

8. The device of claim 1, wherein the test lead cable includes clips adapted to connect to conductor terminals of the neural stimulation lead.

9. The device of claim 1, further comprising a controller to communicate with the pacing circuit and the sensing circuit to receive a sensed physiologic response, and automatically adjust an intensity of the test neural stimulation signal until the sensed physiologic response corresponds to a target physiologic response.

10. The device of claim 1, wherein:

the device is further adapted to analyze a cardiac stimulation system that includes at least one implantable cardiac stimulation lead;

the pacing circuit is adapted to deliver a test cardiac stimulation signal;

the at least one test lead cable is further adapted to electrically connect the pacing circuit and the implantable cardiac stimulation lead; and

the at least one physiological sensor includes a sensor adapted to sense a physiologic response to cardiac stimulation.

11. The device of claim 10, wherein the neural stimulation lead and the cardiac stimulation lead are integrated into one lead.

12. A device to analyze an implantable neural stimulation system that includes an implantable neural stimulation lead for an implantable neural stimulator to be implanted into a patient, comprising:

an external housing;

a pacing circuit in the housing, the pacing circuit adapted to deliver a test neural stimulation signal;

at least one test lead cable adapted to electrically connect the pacing circuit and the implantable neural stimulation lead to enable the test neural stimulation signal to be delivered to a vagus nerve through the test lead cable and the implantable neural stimulation lead, the at least one test lead cable including at least one clip to connect to at least one terminal of the neural stimulation lead;

a sensing circuit in the housing;

a plurality of ECG electrodes adapted for use in detecting an electrocardiogram;

at least one sensor cable adapted to electrically connect the sensing circuit and the plurality of ECG electrodes; and

a controller adapted to communicate with the pacing circuit and the sensing circuit to process the electrocardiogram for use in identifying a response to stimulation of the vagus nerve.

13. The device of claim 12, further comprising a display and a controller adapted to communicate with the pacing circuit, the sensing circuit and the display to provide an indication on the display whether the test neural stimulation signal results in a desired physiological response for stimulation of the vagus nerve.

14. The device of claim 12, wherein the controller is adapted to communicate with the pacing circuit and the sensing circuit to analyze heart rate variability in response to stimulation of the neural target.

15. The device of claim 12, wherein the pacing circuit is further adapted to provide a cardiac stimulation signal.

16. The device of claim 15, wherein the controller is adapted to communicate with the pacing circuit to trigger a premature ventricular pace and communicate with the sensing circuit to analyze heart rate turbulence in response to stimulation of the neural target and the premature ventricular pace.

17. A system for analyzing an implantable neural stimulation system, comprising:

means for connecting a test lead cable for an external analyzer to at least one terminal of an implantable neural stimulation lead;

means for delivering test neural stimulation using an external neural stimulation through the test lead cable and the neural stimulation to a neural target; and

means for monitoring a physiologic response to the test neural stimulation.

18. The system of claim 17, wherein the means for monitoring includes a plurality of ECG electrodes.

19. The system of claim 17, wherein:

the means for monitoring includes means for monitoring a response to vagal stimulation; and

the means for monitoring the response includes means for monitoring heart rate, heart rate variability, or heart rate turbulence.

20. A method for analyzing an implantable neural stimulation system, comprising:

implanting a neural stimulation lead to be used to deliver neural stimulation to a neural target;

connecting a test lead cable for an external analyzer to at least one terminal of the neural stimulation lead;

delivering test neural stimulation using an external neural stimulation through the test lead cable and the neural stimulation to the neural target; and

monitoring a physiologic response to the test neural stimulation.

21. The method of claim 20, wherein implanting the neural stimulation lead includes implanting the neural stimulation lead to be used to deliver neural stimulation to a vagus nerve.

22. The method of claim 20, wherein connecting the test lead cable includes mechanically and electrically attaching the test lead cable to the at least one terminal of the neural stimulation lead.

23. The method of claim 22, wherein connecting the test lead cable includes attaching the test lead cable to the at least one terminal of the neural stimulation lead using at least one clip.

24. The method of claim 20, wherein monitoring the physiologic response to the test neural stimulation includes monitoring heart rate, heart rate variability, or heart rate turbulence.

25. The method of claim 20, further comprising adjusting an implanted position of the neural stimulation lead if the physiologic response to the neural stimulation is not a desired response.

26. The method of claim 20, further comprising:

implanting a cardiac stimulation lead;

connecting a cardiac stimulation test cable for the external analyzer to at least one lead of the cardiac stimulation lead;

delivering test cardiac stimulation; and

monitoring a response to the cardiac stimulation.