Systems, methods, and visualization tools for stimulation and sensing of neural systems with system-level interaction models

• US 9,586,053 B2
• Filed: 11/11/2014
• Issued: 03/07/2017
• Est. Priority Date: 11/14/2013
• 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., Carbunaru, Rafael
• Primary Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US14/538,066
• Publication Number:
  US 20150134031A1
• Time in Patent Office: 847 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware

Abstract

A computer implemented system and method generates a patient-specific model of patient response to stimulation on a neural element basis, receives user-input of target neuromodulation sites, and, based on the patient-specific model, determines which stimulation paradigm and settings, including stimulation sites, would result in the target neuromodulation, where the stimulation sites are not necessarily the same as the resulting neuromodulation sites. The system outputs a visual representation of the stimulation sites that would result in the target neuromodulation. The system monitors a system state and/or patient state and dynamically changes which stimulation program to implement based on the state.

Claims

1. A computer-implemented method comprising:

receiving, by a computer processor, user input selecting a neuromodulation effect region in a brain of a patient;

responsive to the input, determining, by the processor, electrode neuromodulation settings, including a target stimulation region in the brain of the patient, estimated by the processor to, when applied to an electrode leadwire implanted at the target stimulation region, directly stimulate the target stimulation region which produces a neuromodulation response at the selected neuromodulation effect region in the brain of the patient which is a distance from the target stimulation region, wherein the determination is based on a patient-specific mapping that is specific to the patient and that is based on sensor data indicating prior neural responses in the brain of the patient to previous neuromodulations; and

communicating the electrode neuromodulation settings for reception by an implantable pulse generator to perform neuromodulation in the brain of the patient using an electrode leadwire coupled to the implantable pulse generator.

2. The method of claim 1, wherein the user input specifies the neuromodulation effect region as a region at which neural activity is to be reduced.

3. The method of claim 1, wherein the selected neuromodulation effect region is one of a plurality of neuromodulation effect regions in the brain of the patient selected by the user input, and the determining includes determining one or more sets of neuromodulation settings to be distributed to one or more electrodes of the leadwire to produce a selected therapeutic effect at the plurality of neuromodulation effect regions.

4. The method of claim 1, further comprising generating the patient-specific mapping, the generation of the patient-specific mapping including:

performing a plurality of neuromodulations at a respective plurality of sets of neuromodulation settings; and

recording, for each of at least a subset of the neuromodulations, at least one neuromodulation effect occurring at a respective one or more anatomical regions in the brain of the patient, the one or more anatomical region being responsively mapped by the processor to a respective one or more stimulation regions of brain tissue estimated by the processor to have been activated by the respective neuromodulation.

5. The method of claim 4, wherein at least some of the neuromodulation effects are sensed by electrodes of the leadwire.

6. The method of claim 5, wherein the plurality of neuromodulations are performed by electrodes of the leadwire different than the electrodes that sensed the at least some of the neuromodulation effects.

7. The method of claim 5, wherein each of at least a subset of the electrodes of the leadwire are configured to both perform a neuromodulation and sense an effect of a neuromodulation.

8. The method of claim 4, wherein at least some of the neuromodulation effects are input by a user.

9. The method of claim 4, wherein the leadwire includes more than 16 electrodes.

10. The method of claim 9, wherein the lead wire is controlled via an implanted pulse generator that is configured to cause 32 electrodes of the leadwire to simultaneously output an electrical stimulation pulse.

11. The method of claim 9, wherein the leadwire is one of a plurality of leadwires that are all controlled via an implanted pulse generator that is configured to cause 32 electrodes of the plurality of leadwires to simultaneously output an electrical stimulation pulse.

12. The method of claim 1, further comprising receiving, by the processor, additional sensor data from the brain of the patient in response to performance of neuromodulation using the electrode neuromodulation settings.

13. The method of claim 12, further comprising modifying, by the processor, the electrode neuromodulation settings in response to the additional sensor data.

14. The method of claim 13, wherein modifying the electrode neuromodulation settings comprises wherein modifying the electrode neuromodulation settings based on sensor readings of a plurality of electrodes positioned at a respective plurality of anatomical locations.

15. The method of claim 12, wherein the additional sensor data is received from at least one sensor implanted in the brain of the patient.

16. The method of claim 12, wherein the additional sensor data is received from a plurality of electrodes positioned at a respective plurality of anatomical locations in the brain of the patient.

17. The method of claim 13, wherein the additional sensor data indicates a mean firing rate of neural elements, the modification being based on the mean firing rate.

18. The method of claim 12, wherein the additional sensor data are power readings at a specified frequency band.

19. The method of claim 12, wherein the additional sensor data are local field potentials.