Automatic neural stimulation titration sweep

• US 8,942,819 B2
• Filed: 06/08/2011
• Issued: 01/27/2015
• 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.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US13/155,549
• Publication Number:
  US 20110313488A1
• Time in Patent Office: 1,329 Days
• Field of Search: 607/2, 607/9, 607/63
• US Class Current: 607/63
• 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 circuitry is configured to communicate with the sensor circuitry;

a memory with instructions operable on by the controller circuitry, wherein the controller circuitry is configured to operate on the instructions to;

deliver neural stimulation using the neural stimulation output circuitry;

control a titration sweep, wherein the titration sweep varies stimulation parameter values among a limited number of defined parameter sets, wherein each of the defined parameter sets is associated with a defined safety limit that determines a maximum current for a given one of the defined parameter sets, and wherein the instructions for controlling the titration sweep include instructions for changing current amplitude up to the maximum current, and changing to at least one other parameter set from the limited number of defined parameter sets; and

monitor a response to the titration sweep including monitor for a desirable response indicative of efficacious neural stimulation and an undesirable response indicative of intolerable neural stimulation, the instructions for controlling the titration sweep being responsive to monitored responses; and

use the monitored response to automatically select a defined parameter set from the limited number of defined parameter sets, and use the automatically-selected defined parameter set to automatically select stimulation parameters that provide an efficacious neural stimulation and provide a desirable safety margin to prevent injury to neural tissue, wherein the automatically-selected stimulation parameters include a current value that does not exceed the maximum current for the automatically-selected parameter set and do not violate neural stimulation safety limits for a charge per phase or a charge density per phase.

2. The neural stimulator according to claim 1, wherein the controller is configured to operate on the instructions to calculate the safety limit for the stimulation parameters, and confirm 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 controller is configured to operate on the instructions to calculate changes to a current amplitude, a pulse width and a frequency among the limited number of defined parameter sets during the titration sweep, and control the neural stimulation output circuitry to control changes to the current amplitude, the pulse width and the frequency during the titration sweep.

4. The neural stimulator of claim 1, further comprising an input connected to the controller circuitry and configured to receive a patient tolerance input signal indicative of whether the neural stimulation is intolerable, wherein the controller circuitry is configured to use the patient tolerance input signal to control the titration sweep.

5. The neural stimulator of claim 4, 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.

6. The neural stimulator of claim 1, wherein the controller is configured to operate on the instructions to increment current amplitude until the current amplitude reaches the maximum current, and change pulse width when the maximum current is reached.

7. The neural stimulator of claim 1, wherein the controller is configured to operate on the instructions to select a defined parameter set that maximize the safety margin for the parameter sets evaluated during the titration sweep.

8. The neural stimulator of claim 1, wherein the memory includes the limited number of parameter sets.

9. The neural stimulator of claim 1, wherein the neural stimulation output circuitry is configured to adjust current amplitude and is further configured to adjust at least one parameter selected from the group of parameters consisting of:

a pulse width, a stimulation frequency, an electrode configuration and a dose of the neural stimulation.

10. The neural stimulator of claim 1, wherein the neural stimulator is configured to provide a consistent dose of neural stimulation, and each of the defined parameter sets include selected neural stimulation parameters to provide the consistent dose of neural stimulation.

11. The neural stimulator of claim 1, wherein the controller is configured to operate on the instructions to control changes to a pulse width among the limited number of defined parameter sets during the titration sweep.

12. The neural stimulator of claim 1, wherein the controller is configured to operate on the instructions to control changes to a frequency among the limited number of defined parameter sets during the titration sweep.

13. The neural stimulator of claim 1, further comprising an input connected to the controller circuitry and configured to receive a patient tolerance input signal indicative of whether the neural stimulation is intolerable, wherein the controller circuitry is configured to use the patient tolerance input signal to control the titration sweep, 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.

14. 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, wherein the neural stimulation output circuitry is configured to adjust current amplitude and is further configured to adjust at least one parameter selected from the group of parameters consisting of;

a pulse width, a stimulation frequency, an electrode configuration and a dose of the neural stimulation;

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

a memory with instructions operable on by the controller circuitry, wherein the controller circuitry is configured to operate on the instructions to;

deliver neural stimulation using the neural stimulation output circuitry;

control a titration sweep, wherein the titration sweep varies stimulation parameter values among a limited number of defined parameter sets, wherein each of the defined parameter sets is associated with a defined safety limit that determines a maximum current for a given one of the defined parameter sets, and wherein the instructions for controlling the titration sweep include instructions for changing current amplitude up to the maximum current, and changing to at least one other parameter set from the limited number of defined parameter sets; and

monitor a response to the titration sweep including monitor for a desirable response indicative of efficacious neural stimulation and an undesirable response indicative of intolerable neural stimulation, the instructions tier controlling the titration sweep being responsive to monitored responses; and

use the monitored response to automatically select a defined parameter set from the limited number of defined parameter sets, and use the automatically-selected defined parameter set to automatically select stimulation parameters that provide an efficacious neural stimulation and provide a desirable safety margin to prevent injury to neural tissue, wherein the automatically-selected stimulation parameters include a current value that does not exceed the maximum current for the automatically-selected parameter set and do not violate neural stimulation safety limits for a charge per phase or a charge density per phase; and

an input connected to the controller circuitry and configured to receive a patient tolerance input signal indicative of whether the neural stimulation is intolerable, wherein the controller circuitry is configured to use the patient tolerance input signal to control the titration sweep, 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.

15. The neural stimulator of claim 14, wherein the memory includes the limited number of parameter sets.

16. The neural stimulator of claim 14, wherein the controller is configured to operate on the instructions to control changes to a pulse width among the limited number of defined parameter sets during the titration sweep.

17. The neural stimulator of claim 14, wherein the controller is configured to operate on the instructions to control changes to a frequency among the limited number of defined parameter sets during the titration sweep.

18. The neural stimulator of claim 14, wherein the controller is configured to operate on the instructions to calculate the safety limit for the stimulation parameters, and confirm that the charge per phase and charge density per phase does not violate the safety limit.

19. The neural stimulator of claim 14, wherein the controller is configured to operate on the instructions to calculate changes to a current amplitude, a pulse width and a frequency among the limited number of defined parameter sets during the titration sweep, and control the neural stimulation output circuitry to control changes to the current amplitude, the pulse width. and the frequency during the titration sweep.

20. The neural stimulator of claim 14, further comprising an input connected to the controller circuitry and configured to receive a patient tolerance input signal indicative of whether the neural stimulation is intolerable, wherein the controller circuitry is configured to use the patient tolerance input signal to control the titration sweep.