Perception calibration of neural tissue using field troll

• US 9,737,715 B2
• Filed: 09/22/2015
• Issued: 08/22/2017
• Est. Priority Date: 09/23/2014
• 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., Hershey, Bradley Lawrence, Zhu, Changfang, Parramon, Jordi, Kothandaraman, Sridhar
• Primary Examiner(s): Patton, Amanda
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US14/861,124
• Publication Number:
  US 20160082261A1
• Time in Patent Office: 700 Days
• Field of Search: 607 46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• 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

An example of a system may include an electrode arrangement, a neural modulation generator configured to use electrodes in the electrode arrangement to generate a modulation field, a communication module configured to receive commands, a memory configured to store modulation field parameter data, and a controller configured to control the neural modulation generator to generate the modulation field. The controller may be configured to implement a trolling routine to troll the modulation field through neural tissue positions, and implement a marking routine multiple times as the modulation field is trolled through the neural tissue positions to identify when the modulation field provides patient-perceived modulation. The marking procedure implemented by the controller may receive a marking command that indicates that a modulation intensity achieved the patient-perceived modulation, and store in the memory the modulation field parameter data that affects the modulation intensity in response to receiving the marking command.

Claims

1. A method, comprising:

implementing a trolling routine to troll a modulation field, using an arrangement of electrodes on at least one lead, through positions within a volume of a targeted tissue including a plurality of neural tissue positions;

performing a marking procedure multiple times during the trolling routine as the modulation field is trolled through the plurality of neural tissue positions, the marking procedure being performed when the modulation field is at each of the plurality of neural tissue positions, the marking procedure to identify when the modulation field provides patient-perceived modulation, the marking procedure including;

receiving a marking signal that indicates that a modulation intensity of the modulation field achieved the patient-perceived stimulation; and

storing modulation field parameter data that affects the modulation intensity of the modulation field in response to receiving the marking signal.

2. The method of claim 1, further comprising estimating, using the modulation field parameter values, relative excitation of neural tissue as a function of neural tissue position, and using the estimated relative excitation to program modulation energy to be delivered through one or more electrodes in the arrangement of electrodes.

3. The method of claim 1, wherein the marking process includes:

receiving a titration signal that indicates an instruction to adjust the modulation intensity;

adjusting the modulation intensity in response to receiving the titration signal; and

receiving the marking signal that indicates the adjusted modulation intensity achieved the patient-perceived modulation.

4. The method of claim 3, wherein after receiving the marking signal, beginning a subsequent marking process at the adjusted intensity of the modulation field, the subsequent marking process further comprising:

subsequently adjusting the adjusted modulation intensity in response to receiving a subsequent titration signal, and receiving a subsequent marking signal that indicates the subsequently-adjusted modulation intensity achieved the patient-perceived modulation.

5. The method of claim 1, wherein the implementing the trolling routine includes automatically moving the modulation field.

6. The method of claim 1, wherein the implementing the trolling routine includes a patient-controlled movement of the modulation field.

7. The method of claim 1, wherein the implementing the trolling routine includes moving a monopolar modulation field in which:

a case electrode is configured as an anode and electrodes within the arrangement of electrodes are configured as cathodes;

the case electrode is configured as a cathode and the electrodes within the arrangement of electrodes are configured as anodes;

or

the electrodes within the arrangement of electrodes are configured as anodes or cathodes.

8. The method of claim 1, wherein estimating includes directly using the stored modulation field data to estimate the relative excitation.

9. The method of claim 1, wherein estimating includes implementing a model using the stored modulation field data as inputs to estimate the relative excitation.

10. The method of claim 1, wherein the patient-perceived modulation includes paresthesia.

11. The method of claim 1, wherein the implementing the trolling routine includes changing fractionalized current values for electrodes within arrangement of electrodes to move the modulation field through neural tissue positions.

12. The method of claim 1, wherein the implementing the trolling routine includes using at least one timing channel to generate at least two different fields to the patient.

13. A method, comprising:

trolling a monopolar modulation field through neural tissue positions, wherein trolling includes moving the monopolar modulation field in which;

a case electrode is configured as an anode and electrodes within an arrangement of electrodes are configured as cathodes;

the case electrode is configured as a cathode and electrodes within the arrangement of electrodes are configured as anodes;

or

the electrodes within the arrangement of electrodes are configured as anodes or cathodes;

performing a marking process multiple times as the monopolar modulation field is trolled through the neural tissue positions, the marking process to identify when the modulation field provides patient-perceived modulation, the marking process including;

receiving a titration signal that indicates an instruction to adjust modulation intensity of the monopolar modulation field;

in response to receiving the titration signal adjusting a current amplitude to provide a present current amplitude for an electrode in the arrangement of electrodes;

receiving a marking signal that indicates that the present current amplitude for the electrode provided the monopolar modulation field with a present modulation intensity that achieved paresthesia;

storing the present current amplitude in response to receiving the marking signal; and

repeating the receiving the titration signal, the adjusting, the receiving the marking signal, and the storing for subsequent electrodes in the arrangement of electrodes;

estimating, using the present current amplitudes for the marking processes performed as the monopolar modulation field is trolled, relative excitation of the dorsal horn tissue as a function of the neural tissue positions along the array; and

using the estimated relative excitation to program an amplitude of the current to be delivered through one or more the stimulation electrodes.

14. The method of claim 13, wherein the targeted level of paresthesia includes a patient perception threshold for the patient to perceive paresthesia or a patient tolerance threshold for the patient to tolerate paresthesia.

15. A system, comprising:

a neural modulation generator configured to use electrodes in an electrode arrangement to generate a modulation field;

a communication module configured to receive commands;

a memory configured to store modulation field parameter data; and

a controller configured to control the neural modulation generator to generate the modulation field, the controller configured to;

implement a trolling routine to troll the modulation field through positions within a volume of a targeted tissue including a plurality of neural tissue positions; and

implement a marking routine multiple times during the trolling routine as the modulation field is trolled through the plurality of neural tissue positions to identify when the modulation field provides patient-perceived modulation, the marking procedure being performed when the modulation field is at each of the plurality of neural tissue positions, the marking procedure implemented by the controller to receive a marking command that indicates that a modulation intensity achieved the patient-perceived modulation, and to store in the memory the modulation field parameter data that affects the modulation intensity in response to receiving the marking command.

16. The system of claim 15, wherein the controller is configured to:

estimate, using the stored modulation field parameter values, relative excitation of dorsal horn tissue as a function of neural tissue position; and

use the estimated relative excitation to program modulation energy to be delivered through one or more of the electrodes in the electrode arrangement.

17. The system of claim 15, wherein the marking procedure implemented by the controller is configured to use the communication module to receive a titration signal that indicates an instruction to adjust the modulation intensity, adjust the modulation intensity in response to receiving the titration signal, and receive the marking command that indicates the adjusted modulation intensity achieved the patient-perceived modulation.

18. The system of claim 15, wherein the patient-perceived modulation includes a patient perception threshold for the patient to perceive paresthesia or a patient tolerance threshold for the patient to tolerate paresthesia.

19. The system of claim 15, wherein the trolling routine implemented by the controller is configured to change fractionalized current values for electrodes within the electrode arrangement to move the modulation field.

20. The system of claim 15, wherein:

the system includes an implantable device and an external device;

the implantable device includes the neural stimulation generator, the communication module, the memory and the controller;

the external device is configured to send commands to the implantable device and provide a graphical user interface, the graphical user interface to provide a current amplitude control configured to be controlled by the patient to adjust the current amplitude during the trolling routine or to provide a current and pulse width control configured to adjust the current amplitude and pulse width during the trolling routine,

the graphical user interface to provide at least one of;

a trolling start configured to be controlled by the patient to initiate the trolling routine;

a speed control configured to be controlled by the patient to set or modify a speed for changing positions during the trolling routine;

a resolution control to specify a step size for trolling;

or a pause control configured to be controlled by the patient to set one or more pauses in the trolling routine, and

the graphical user interface to further provide at least one of;

a graphical lead indicator configured to indicate a part of the array of electrodes to troll during the trolling routine;

or a graphical field indicator to indicate the position of the field on the array of electrodes during the trolling routine.