Systems and methods for closed-loop determination of stimulation parameter settings for an electrical simulation system

• US 10,603,498 B2
• Filed: 10/13/2017
• Issued: 03/31/2020
• Est. Priority Date: 10/14/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Blum, David, Lin, Sherry, Bokil, Hemant, Moffitt, Michael A.
• Primary Examiner(s): Wehrheim, Lindsey G
• Application Number:
  US15/783,961
• Publication Number:
  US 20180104500A1
• Time in Patent Office: 900 Days
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• 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 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A method or system for facilitating the determining and setting of stimulation parameters for programming an electrical stimulation system using closed loop programming is provided. For example, pulse generator feedback logic is executed by a processor to interface with control instructions of an implantable pulse generator by incorporating one or more machine learning engines to automatically generate a proposed set of stimulation parameter values that each affect a stimulation aspect of the implantable pulse generator, receive one or more clinical responses and automatically generate a revised set of values taking into account the received clinical responses, and repeating the automated receiving of a clinical response and adjusting the stimulation parameter values taking the clinical response into account, until or unless a stop condition is reach or the a therapeutic response is indicated within a designated tolerance.

Claims

1. A computing system for facilitating programming settings of an implantable pulse generator associated with a patient, comprising:

a processor;

a memory; and

pulse generator feedback control logic, stored in the memory, and configured, when executed by the processor, to interface with control instructions of the implantable pulse generator (IPG) by performing actions of;

incorporating one or more machine learning engines, automatically generating a proposed set of stimulation parameter values that each effect a stimulation aspect of the IPG;

forwarding the automatically generated proposed set of stimulation parameter values to configure stimulation parameters of the IPG to the proposed set of stimulation parameter values;

receiving one or more clinical response values as a result of the IPG being configured to the proposed set of stimulation parameter values;

predicting, by incorporating one or more machine learning engines and using the one or more clinical response values, one or more therapeutic response values for each of a plurality of sets of untested stimulation parameter values;

selecting, based on the predicted one or more therapeutic response values and on a distance of each set of untested stimulation parameter values from one or more previously tested stimulation parameter values, a revised proposed set of stimulation parameter values from the plurality of sets of untested stimulation parameter values;

forwarding the selected revised proposed set of stimulation parameter values to configure stimulation parameters of the IPG to the revised proposed set of stimulation parameter values; and

repeating the receiving one or more clinical response values as a result of the IPG being configured to the revised proposed set of stimulation parameter values, predicting, by incorporating one or more machine learning engines, the one or more therapeutic response value for each of the plurality of sets of untested stimulation parameter values, selecting the revised proposed set of stimulation parameter values from the plurality of sets of untested stimulation parameter values, and forwarding the selected revised proposed set of stimulation parameter values to configure stimulation parameters of the IPG accordingly, until or unless a stop condition has been reached or the one or more received clinical response values indicates a value that corresponds to a therapeutic response indication within a designated tolerance.

2. The system of claim 1 wherein one or more clinical response values are automatically received from a sensor associated with the patient.

3. The system of claim 1 wherein the pulse generator feedback control logic incorporates multiple machine learning techniques to automatically generate the proposed set of stimulation parameter values or select the revised proposed set of stimulation parameter values.

4. The system of claim 3 wherein the multiple machine learning techniques are deployed simultaneously and rated automatically based upon ability to generate a set of stimulation parameter values that corresponds to the therapeutic response indication within the designated tolerance.

5. The system of claim 1 wherein multiple machine learning engines are deployed to generate multiple predications of the one or more predicted therapeutic response values.

6. The system of claim 5 wherein the selecting of the revised proposed set of stimulation parameter values is based upon one or more rules.

7. The system of claim 6 wherein the one or more rules include at least one of:

a rule based upon retrying locations within a number of iterations, a rule based upon mathematical proximity of proposed sets of stimulation parameter values to sets of stimulation parameter values already tested, a rule based upon values of a stimulation parameter leading to adverse side effects, and/or a rule based upon size of step between values of a same stimulation parameter.

8. The system of claim 1 wherein the receiving one or more clinical response values as a result of the IPG being configured to the proposed set of stimulation parameter values indicates whether an undesired side effect has occurred.

9. The system of claim 1 wherein the selecting of the revised proposed set of stimulation parameter values is determined in each subsequent iteration in contact order, wherein contact order means testing along a first contact until side effects are prohibitive before testing a next proximal contact on a lead.

10. The system of claim 1 wherein the selecting of the revised proposed set of stimulation parameter values is determined in each subsequent iteration by selectively choosing contacts along a main axis of a lead and varying other stimulation parameters for each selectively chosen contact.

11. The system of claim 1 wherein the selecting of the revised proposed set of stimulation parameter values is determined in each subsequent iteration randomly, based upon a model of the patient, a spatial search algorithm, or by varying size of jump to a revised proposed set of stimulation parameter values.

12. A computer-implemented method for automatically determining patient programming settings for an electrical stimulator, comprising:

receiving an indication of a plurality of stimulation parameters and an indication of a desired therapeutic response value;

automatically generating an initial proposed set of stimulation parameter values for testing the electrical stimulator programmed according to these initial values;

receiving an indication of clinical results based upon testing the programmed electrical stimulator on a recipient, wherein the received indication indicates a therapeutic response value;

automatically generating, using machine learning, one or more predicted therapeutic response values for a plurality of values of the plurality of stimulation parameters for which an indication of clinical results has not yet been received;

automatically generating and indicating a next proposed set of stimulation parameter values for testing the electrical stimulator programmed accordingly, based in part on at least one of the one or more predicted therapeutic response values; and

repeating the acts of receiving the indication of clinical results based upon testing the programmed electrical simulator, automatically generating using machine learning the one or more predicted therapeutic response values, and automatically generating and indicating a next proposed set of stimulation parameter values for testing the electrical stimulator programmed accordingly, until or unless a stop condition has been reached or the received indication of clinical results indicates a therapeutic response value that is within a designated tolerance.

13. The method of claim 12 wherein the automatically generating, using machine learning, one or more predicted therapeutic response values for a plurality of values of the plurality of stimulation parameters for which an indication of clinical results has not yet been received uses a training data set based upon prior data of the recipient or of other recipients.

14. The method of claim 12 wherein the indication of clinical results based upon testing the electrical stimulator on a recipient is received from a data repository.

15. The method of claim 12 wherein the automatically generating an initial proposed set of stimulation parameter values is determined using data collected in prior electrical simulator programming sessions.

16. The method of claim 12 wherein multiple machine learning techniques are deployed simultaneously to generate multiple predictions of the one or more predicted therapeutic response values and the multiple machine learning techniques are rated automatically based upon ability to provide an accurate prediction of a therapeutic response measurement.

17. The method of claim 12 wherein the automatically generating a next proposed set of stimulation parameter values determines the next proposed set by ranking possible sets of stimulation parameter values based upon one or more rules.

18. The method of claim 12 wherein value limits are defined for at some of the plurality of stimulation parameters.

19. A computer-readable memory medium containing instructions that control a computer processor, when executed, to automatically determine programming settings of an implantable pulse generator (IPG) associated with a patient by performing a method comprising:

automatically generating a proposed set of values of a plurality of stimulation parameters that each effect a stimulation aspect of the IPG;

causing stimulation parameters of the IPG to be set to the automatically generated proposed set of stimulation parameter values;

receiving one or more clinical response values as a result of the IPG being set to the proposed set of stimulation parameter values;

predicting, by incorporating one or more machine learning engines and using the one or more clinical response values, at least one therapeutic response value for each of a plurality of sets of untested stimulation parameter values;

selecting, based on the at least one predicted therapeutic response value and on a distance of each set of untested stimulation parameter values from one or more previously tested stimulation parameter values, a revised proposed set of stimulation parameter values from the plurality of sets of untested stimulation parameter values;

forwarding the selected revised proposed set of stimulation parameter valves to configure stimulation parameters of the IPG to the revised proposed set of stimulation parameter values; and

repeating the receiving one or more clinical response values as a result of the IPG being configured to the revised proposed set of stimulation parameter values, predicting, by incorporating one or more machine learning engines, the at least on therapeutic response value for each of the plurality of sets of untested stimulation parameter values, selecting the revised proposed set of stimulation parameter values from the plurality of sets of untested stimulation parameter values, and forwarding the selected revised proposed set of stimulation parameter values to configure stimulation parameters of the IPG accordingly, until or unless a stop condition has been reached or the one or more received clinical response values indicates a value that corresponds to a therapeutic response indication within a designated tolerance.

20. The computer-readable memory medium of claim 19 wherein the method comprises utilizing multiple machine learning techniques to automatically generate the proposed set of stimulation parameter values or select the revised proposed set of stimulation parameter values.