AUTOMATIC NEURAL STIMULATION TITRATION SWEEP

• US 20110313488A1
• Filed: 06/08/2011
• Published: 12/22/2011
• Est. Priority Date: 06/16/2010
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hincapie Ordonez, Juan Gabriel, Ruble, Stephen, Hamann, Jason J., Mokelke, Eric A., Arcot-Krishnamurthy, Shantha, Stalsberg, Kevin John, Ternes, David J.
• Granted Patent: US 8,942,819 B2
• Time in Patent Office: Days
• US Class Current: 607/59
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters

Abstract

Various neural stimulator embodiments comprise controller circuitry, neural stimulation output circuitry, sensor circuitry and a memory. The neural stimulation output circuitry is configured to deliver the neural stimulation. The controller circuitry is configured to control stimulation parameters of the neural stimulation delivered by the neural stimulation output circuitry. The sensor circuitry, including at least one sensor, is configured to sense a response to the neural stimulation. The controller is configured to communicate with the sensor circuitry. The memory has instructions stored therein, operable on by the controller circuitry. The instructions include instructions for delivering neural stimulation using the neural stimulation output circuitry, instructions for controlling a titration sweep wherein the titration sweep varies stimulation parameter values, and instructions for monitoring a response to the titration sweep and automatically selecting stimulation parameters that provide an efficacious neural stimulation and provide a desirable safety margin to prevent injury to neural tissue.

Claims

1. A neural stimulator, comprising:

controller circuitry;

neural stimulation output circuitry configured to deliver the neural stimulation, wherein the controller circuitry is configured to control stimulation parameters of the neural stimulation delivered by the neural stimulation output circuitry;

sensor circuitry, including at least one sensor, configured to sense a response to the neural stimulation, wherein the controller is configured to communicate with the sensor circuitry;

a memory with instructions operable on by the controller circuitry, wherein the instructions include;

instructions for delivering neural stimulation using the neural stimulation output circuitry;

instructions for controlling a titration sweep, wherein the titration sweep varies stimulation parameter values; and

instructions for monitoring a response to the titration sweep and automatically selecting stimulation parameters that provide an efficacious neural stimulation and provide a desirable safety margin to prevent injury to neural tissue.

2. The neural stimulator of claim 1, wherein the instructions in the memory include instructions for calculating a safety limit for the stimulation parameters, and confirming that the charge per phase and charge density per phase does not violate the safety limit.

3. The neural stimulator of claim 1, wherein the memory includes a plurality of neural stimulation parameter sets, wherein each set includes a unique combination of parameter values for the neural stimulation and wherein each unique combination of parameter values is defined to provide a charge per phase and charge density per phase that avoids damage to the neural tissue, wherein the instructions for controlling the titration sweep includes instructions for stepping through the plurality of neural stimulation parameter sets.

4. The neural stimulator of claim 1, wherein the neural stimulation output circuitry is configured to adjust at least one of a current amplitude, a pulse width, a stimulation frequency, an electrode configuration or a dose of the neural stimulation.

5. The neural stimulator of claim 1, wherein the instructions for controlling a titration sweep includes instructions for controlling changes to a current amplitude during the titration sweep, and wherein the controller is configured to use the instructions for controlling changes to the current amplitude during the titration sweep to control the neural stimulation output circuitry.

6. The neural stimulator of claim 1, wherein the instructions for controlling a titration sweep includes instructions for controlling changes to a pulse width during the titration sweep, and wherein the controller is configured to use the instructions for controlling changes to the pulse width during the titration sweep to control the neural stimulation output circuitry.

7. The neural stimulator of claim 1, wherein the instructions for controlling a titration sweep includes instructions for controlling changes to a frequency during the titration sweep, and wherein the controller is configured to use the instructions for controlling changes to the frequency during the titration sweep to control the neural stimulation output circuitry.

8. The neural stimulator of claim 1, wherein the instructions for controlling a titration sweep includes instructions for controlling changes to a current amplitude, a pulse width and a frequency during the titration sweep, and wherein the controller is configured to use the instructions for controlling changes to the current amplitude, the pulse width and the frequency during the titration sweep to control the neural stimulation output circuitry.

9. The neural stimulator of claim 1, fluffier comprising an input connected to the controller circuitry and configured to receive a patient tolerance input signal, wherein the controller circuitry is configured to use the patient tolerance input signal to control the titration sweep through the neural stimulation parameter values.

10. The neural stimulator of claim 9, wherein the input is configured to receive a communication signal from a programmer, wherein the programmer is configured to be used by a clinician to program the neural stimulator and to receive an entry from the clinician regarding patient tolerance to the neural stimulation.

11. The neural stimulator of claim 9, wherein the input is configured to receive a communication signal from an external device that is configured to be used by a patient, wherein the external device is configured to receive an entry from the patient regarding patient tolerance to the neural stimulation.

12. The neural stimulator of claim 1, wherein the instructions for controlling a titration sweep to change values for the stimulation parameters of the delivered neural stimulation includes instructions for incrementing current amplitude until the current amplitude reaches a safety limit, and changing pulse width when the safety limit for the current amplitude is reached.

13. The neural stimulator of claim 1, wherein the instructions for monitoring a response to the titration sweep and automatically selecting stimulation parameters includes instructions for selecting stimulation parameters that maximize the safety margin for the parameter sets evaluated during the titration sweep.

14. A method for programming neural stimulation parameters into a neural stimulator, comprising:

delivering a neural stimulation to a neural target, wherein the neural stimulation has a plurality of stimulation parameters;

performing a titration sweep for the neural stimulation, wherein performing the titration sweep includes varying values for the plurality of stimulation parameters;

monitoring a physiological response to determine stimulation efficacy for the various parameter values;

determining desirable parameter values that provide efficacious neural stimulation and that have a desirable stimulation safety margin to avoid injury to neural tissue; and

programming the neural stimulator with the parameter values that provide efficacious neural stimulation and that have the desirable stimulation safety margin.

15. The method of claim 14, further comprising calculating a safety limit for the values of the neural stimulation parameters.

16. The method of claim 14, wherein performing the titration sweep for the neural stimulation includes stepping through defined sets of neural stimulation parameter values stored in a memory of the neural stimulator, wherein each defined set includes values determined to maintain the desirable safety margin.

17. The method of claim 14, wherein performing the titration sweep for the neural stimulation includes:

setting the neural stimulation parameter values to initial values, wherein the neural stimulation parameter values include a pulse width and a current amplitude;

incrementing the current amplitude until the current amplitude reaches a safety limit for the initial pulse width; and

upon reaching the safety limit, resetting the current amplitude to the initial value and changing the pulse width to a second value, and then incrementing the current amplitude until the current amplitude reaches a safety limit for the second value of the pulse width.

18. The method of claim 17, wherein performing the titration sweep includes decrementing the current amplitude in response to receiving a signal indicating that the patient does not find the neural stimulation to be tolerable.

19. The method of claim 14, wherein determining desirable parameter values that provide efficacious neural stimulation and that have a desirable stimulation safety margin includes determining desirable parameter values that maximize the safety margin.

20. The method of claim 14, wherein programming the neural stimulator with the parameter values includes automatically programming the neural stimulator with the parameter values that have been determined to provide efficacious neural stimulation and that have the desirable stimulation safety margin.