Neurostimulation system with flexible patterning and waveforms

• US 9,597,517 B2
• Filed: 07/01/2015
• Issued: 03/21/2017
• Est. Priority Date: 07/03/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Moffitt, Michael A.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US14/789,698
• Publication Number:
  US 20160001087A1
• Time in Patent Office: 629 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A neurostimulation system configured for providing neurostimulation therapy to a patient. A user customizes a pulse pattern on a pulse-by-pulse basis. Electrical stimulation energy is delivered to at least one electrode in accordance with the customized pulse pattern.

Claims

1. An external control device configured for controlling a neurostimulator implanted within a patient, comprising:

a user interface configured for receiving an input from a user;

telemetry circuitry configured for communicating with the neurostimulator; and

a control circuitry configured for customizing a pulse pattern on a pulse-by-pulse basis in response to the input from the user, and instructing the neurostimulator via the telemetry circuitry to deliver electrical stimulation energy to the patient in accordance with the customized pulse pattern.

2. The external control device of claim 1, wherein the control circuitry is configured for independently defining the interpulse intervals between adjacent pairs of pulses in the pulse pattern in response to the input from the user.

3. The external control device of claim 1, wherein the control circuitry is configured for independently defining the widths of pulses in the pulse pattern in response to the input from the user.

4. The external control device of claim 1, wherein the control circuitry is configured for independently defining the amplitudes of pulses in the pulse pattern in response to the input from the user.

5. The external control device of claim 1, wherein the control circuitry is configured for independently defining the electrode combinations that deliver pulses in the pulse pattern in response to the input from the user.

6. The external control device of claim 1, wherein the control circuitry is configured for adding or subtracting a pulse to or from the pulse pattern in response to the input from the user.

7. The external control device of claim 1, wherein the control circuitry is configured for customizing the pulse pattern on the pulse-by-pulse basis by adjusting a multiplicative factor that is applied to a baseline stimulation parameter of the pulse pattern in response to the input from the user.

8. The external control device claim 1, wherein the neurostimulator comprises an Application Specific Integrated Circuit (ASIC), and the control circuitry is configured for programming the ASIC to generate the customized pulse pattern.

9. The external control device of claim 1, wherein the user interface is configured for displaying the pulse pattern, and the control circuitry is configured for customizing the pulse pattern by allowing the user to drag a portion of the displayed pulse pattern using a pointing element.

10. The external control device of claim 1, wherein the control circuitry is configured for limiting the customization of the pulse pattern in accordance with a set of heuristic safety/regulatory rules.

11. The external control device of claim 1, further comprising memory configured for storing a plurality of different customized pulse patterns, wherein the control circuitry is configured for selecting one or more of the customized pulse patterns in response to the input from the user, recalling the selected one or more pulse patterns from the memory, and instructing the neurostimulator via the telemetry circuitry to deliver the electrical stimulation energy in accordance with the recalled one or more pulse patterns.

12. The external control device of claim 1, wherein the control circuitry is configured for customizing another pulse pattern on a pulse-by-pulse basis in response to the input from the user, and instructing the neurostimulator to concurrently deliver the electrical stimulation energy in accordance with the customized pulse pattern and the other customized pulse pattern respectively in two timing channels.

13. The external control device of claim 12, wherein the control circuitry is configured for defining a phase offset between the customized pulse pattern and the other customized pulse pattern within the respective timing channels in response to the input from the user.

14. The external control device of claim 1, wherein the control circuitry is configured for globally modifying a stimulation parameter for all pulses of a tonic pulse pattern in response to the input from the user, and for instructing the neurostimulator to deliver the electrical stimulation energy to the patient in accordance with the tonic pulse pattern.

15. The external control device of claim 1, wherein the control circuitry is configured for exporting the customized pulse pattern to a central data base accessible to a plurality of users.

16. A neurostimulation system configured for providing neurostimulation therapy to a patient, comprising:

at least one electrode in contact with tissue of the patient;

a neurostimulator configured for delivering electrical stimulation energy to the at least one electrode;

an external control device configured for allowing a user to customize a pulse pattern on a pulse-by-pulse basis, and for instructing the neurostimulator to deliver the electrical stimulation energy to the at least one electrode in accordance with the customized pulse pattern.

17. The neurostimulation system of claim 16, wherein the external control device is configured for allowing the user to:

independently define the interpulse intervals between adjacent pairs of pulses in the pulse pattern;

or independently define the widths of pulses in the pulse pattern;

or independently define the amplitudes of pulses in the pulse pattern;

or independently define the electrode combinations that deliver pulses in the pulse pattern;

or add or subtract a pulse to or from the pulse pattern;

or customize the pulse pattern on the pulse-by-pulse basis by allowing the user to adjust a multiplicative factor that is applied to a baseline stimulation parameter of the pulse pattern.

18. The neurostimulation system of claim 16, wherein:

the neurostimulator comprises an Application Specific Integrated Circuit (ASIC), and the external control device is configured for programming the ASIC to generate the customized pulse pattern.

19. The neurostimulation system of claim 16, wherein:

the external control device is configured for displaying the pulse pattern, and for allowing the user to customize the pulse pattern by allowing the user to drag a portion of the displayed pulse pattern using a pointing element;

or the external control device is configured for limiting the customization of the pulse pattern in accordance with a set of heuristic safety/regulatory rules;

or the external control device is configured for storing a plurality of different customized pulse patterns, allowing the user to select one or more of the customized pulse patterns, recalling the selected one or more pulse patterns, and instructing the neurostimulator to deliver the electrical stimulation energy in accordance with the recalled one or more pulse patterns;

or the external control device is configured for allowing the user to customize another pulse pattern on a pulse-by-pulse basis, and instructing the neurostimulator to concurrently deliver the electrical stimulation energy in accordance with the customized pulse pattern and the other customized pulse pattern respectively in two timing channels;

or the external control device is configured for allowing the user to define a phase offset between the customized pulse pattern and the other customized pulse pattern within the respective timing channels;

or the external control device is configured for allowing the user to globally modify a stimulation parameter for all pulses of a tonic pulse pattern, and instructing the neurostimulator to deliver the electrical stimulation energy to the at least one electrode in accordance with the tonic pulse pattern;

or the external control device is configured for exporting the customized pulse pattern to a central data base accessible to a plurality of users.

20. The neurostimulation system of claim 16, wherein the neurostimulator is configured for sensing an environmental signal, and the external control device is configured for customizing the pulse pattern on the pulse-by-pulse basis based on the sensed environmental signal.