CLINICAL NEUROSTIMULATION CONTROLLER

• US 20190329050A1
• Filed: 04/25/2018
• Published: 10/31/2019
• Est. Priority Date: 04/25/2018
• Status: Active Application

• Current Assignee: Aleva Neurotherapeutics
• Original Assignee: Aleva Neurotherapeutics
• Inventors: Montavon, Jean-Charles, Michalis, Alexandre, Harbi, Pascal
• Application Number:
  US15/962,632
• Publication Number:
  US 20190329050A1
• Time in Patent Office: Days
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/3615 Intensity
• 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 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

The present disclosure describes system and methods to configure an implantable neurostimulation device. The system can include a programmer for neurostimulation devices. The programmer can be a handheld device that programs the stimulation parameters for both new and existing patients. The programmer can configure the neurostimulation device to iteratively deliver stimulations through each of the lead'"'"'s electrodes. The programmer can receive and record indications of the patient'"'"'s response to each of the stimulations and generate benefit scores or side effect scores based on the patient'"'"'s response. The programmer can determine the scores based on data received from patient monitors, external sensors, and clinician input. Based on the scores, the programmer can generate therapeutic windows for each of the electrodes. The programmer can combine the therapeutic windows into a therapeutic window map.

Claims

1. A system to select stimulation electrodes with a data processing system comprising one or more processors and a memory that execute an interface, a communication component, and a mapping component to:

receive, by the interface, an indication of a configuration of a neurological lead, the neurological lead comprising a plurality of electrodes;

transmit, by the communication component and to an implanted stimulation device, a first message to deliver a first stimulation signal with a first set of stimulation parameters to one of the plurality of electrodes;

transmit, by the communication component and to the implanted stimulation device, a second message to deliver a second stimulation signal with a second set of stimulation parameters to the one of the plurality of electrodes;

receive, by an interface, an indication of a first stimulation effect based on the first stimulation signal to the one of the plurality of electrodes;

receive, by an interface, an indication of a second stimulation effect based on the second stimulation signal to the one of the plurality of electrodes;

determine, by the mapping component, a therapeutic window for the one of the plurality of electrodes based on a difference between the first set of stimulation parameters and the second set of stimulation parameters, the indication of the first stimulation effect, and the indication of the second stimulation effect; and

generate, by the mapping component, a therapeutic window map based on the therapeutic window for the one of the plurality of electrodes and the indication of the configuration of the neurological lead.

2. The system of claim 1, wherein the first stimulation signal has a first current level and the second stimulation signal has a second current level different than the first current level.

3. The system of claim 1, wherein the first stimulation signal has a first voltage level and the second stimulation signal has a second voltage level different than the first voltage level.

4. The system of claim 1, comprising a scoring component to:

determine a benefit score for each of at least the portion of the plurality of electrodes based on the minimum response stimulation parameter; and

determine a side effect score for each of at least the portion of the plurality of electrodes based on the maximum response stimulation parameter.

5. The system of claim 1, comprising:

the communication component to transmit, to the implanted stimulation device, a third message to increase a stimulation parameter to the one of the plurality of electrodes.

6. The system of claim 1, comprising the mapping component to:

determine a minimum response stimulation parameter for each of at least a portion of the plurality of electrodes;

determine a maximum response stimulation parameter for each of at least the portion of the plurality of electrodes; and

determine a therapeutic window for each of at least the portion of the plurality of electrodes based on the minimum response stimulation parameter for each of at least the portion of the plurality of electrodes and the maximum response stimulation parameter for each of at least the portion of the plurality of electrodes.

7. The system of claim 6, comprising:

the mapping component to generate the therapeutic window map based on the therapeutic window for each of at least the portion of the plurality of electrodes.

8. The system of claim 6, comprising:

the mapping component to set at least one of the plurality of electrodes as a stimulation electrode based on the therapeutic window map.

9. The system of claim 1, wherein the indication of the configuration of the neurological lead includes at least one of an electrode number, an electrode size, and an electrode position on the neurological lead.

10. The system of claim 1, comprising:

the interface configured to receive an implantation location of the neurological lead, wherein the implantation location of the neurological lead comprises at least one of an implantation depth, implantation coordinates, and an orientation.

11. A method to select stimulation electrodes of an implantable neurostimulation device, comprising:

receiving an indication of a configuration of a neurological lead, the neurological lead comprising a plurality of electrodes;

transmitting, to an implanted stimulation device, a first message to deliver a first stimulation signal with a first set of stimulation parameters to one of the plurality of electrodes;

transmitting, to the implanted stimulation device, a second message to deliver a second stimulation signal with a second set of stimulation parameters to the one of the plurality of electrodes;

receiving an indication of a first stimulation effect on a patient based on the first stimulation signal to the one of the plurality of electrodes;

receiving an indication of a second stimulation effect on the patient based on the second stimulation signal to the one of the plurality of electrodes;

determining a therapeutic window for the one of the plurality of electrodes based on a difference between the first set of stimulation parameters and the second set of stimulation parameters, the indication of the first stimulation effect, and the indication of the second stimulation effect; and

generating a therapeutic window map based on the therapeutic window for the one of the plurality of electrodes and the indication of the configuration of the neurological lead.

12. The method of claim 11, wherein the first stimulation signal has a first current level and the second stimulation signal has a second current level different than the first current level.

13. The method of claim 11, wherein the first stimulation signal has a first voltage level and the second stimulation signal has a second voltage level different than the first voltage level.

14. The method of claim 11, comprising:

transmitting, to the implanted stimulation device, a third message to increase a stimulation parameter to the one of the plurality of electrodes.

15. The method of claim 11, comprising:

determining a benefit score for each of at least the portion of the plurality of electrodes based on the minimum response stimulation parameter; and

determining a side effect score for each of at least the portion of the plurality of electrodes based on the maximum response stimulation parameter.

16. The method of claim 11, comprising:

determining a minimum response stimulation parameter for each of at least a portion of the plurality of electrodes;

determining a maximum response stimulation parameter for each of at least the portion of the plurality of electrodes; and

determining a therapeutic window for each of at least the portion of the plurality of electrodes based on the minimum response stimulation parameter for each of at least the portion of the plurality of electrodes and the maximum response stimulation parameter for each of at least the portion of the plurality of electrodes.

17. The method of claim 16, comprising:

generating the therapeutic window map based on the therapeutic window for each of at least the portion of the plurality of electrodes.

18. The method of claim 16, comprising:

setting at least one of the plurality of electrodes as a stimulation electrode based on the therapeutic window map.

19. The method of claim 11, wherein the indication of the configuration of the neurological lead includes at least one of an electrode number, an electrode size, and an electrode position on the neurological lead.

20. The method of claim 11, comprising:

receiving an implantation location of the neurological lead, wherein the implantation location of the neurological lead comprises at least one of an implantation depth, implantation coordinates, and an orientation.