Systems and methods for the development of therapy paradigms for neurological treatments

• US 10,391,313 B2
• Filed: 12/02/2016
• Issued: 08/27/2019
• Est. Priority Date: 12/04/2015
• 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., Steinke, G. Karl, Kothandaraman, Sridhar, Hershey, Bradley Lawrence, Zhu, Changfang, Parramon, Jordi, Marnfeldt, Goran N., Rivera, John, Carcieri, Stephen
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US15/367,491
• Publication Number:
  US 20170157404A1
• Time in Patent Office: 998 Days
• 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 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37241 providing test stimulations

Abstract

Methods, devices and systems for developing new therapy options for patient suffering from neurological disorders. An example may include the use of a therapy patterning system that allows significant freedom to program therapy patterns using arbitrary shapes and functions. For such patterning to be implemented, a physician may identify a condition needing new and/or alternative therapy options, link the identified condition one or more therapy parameters, program, test and assess the therapy. The process may include multiple iterations to address an initial condition and then to mitigate side effects of the initial therapy. Some embodiments comprises devices configured to deliver combinations of therapy patterns to accomplish at least first and second therapeutic purposes.

Claims

1. A neuromodulation device configured for use with one or more electrodes for delivery of neuromodulation signals, and having operational circuitry including therapy delivery circuitry controllable by the operational circuitry, wherein the operational circuitry is configured to control the therapy delivery circuitry to have at least the following therapeutic outputs programmed:

a first therapy pattern configured to accomplish a first effect on a patient;

a second therapy pattern configured to accomplish a second effect on a patient;

wherein the operational circuitry is configured to output the first therapy pattern and the second therapy pattern using a plurality of the electrodes such that the first effect impacts the second effect; and

wherein the first and second patterns are different from one another insofar as the first therapy pattern is an asymmetric voltage controlled output, and the second therapy pattern is an assymetric current controlled output.

2. The device of claim 1 wherein the first effect is a hyperpolarization effect and the second effect is a stimulation effect, and the first pattern and second pattern are configured to use different subsets of the one or more electrodes to accomplish the first effect and second effect in different volumes of patient tissue.

3. The device of claim 1 wherein the first effect is a subthreshold effect and the second effect is a stimulation effect, and the first pattern and second pattern are configured to use different subsets of the one or more electrodes to accomplish the first effect and second effect in different volumes of patient tissue.

4. The device of claim 1 wherein the first effect is a stimulation effect and the second effect is also a stimulation effect, and the first pattern and second pattern are configured to use different subsets of the one or more electrodes to accomplish the first effect and second effect in different volumes of patient tissue, wherein the first effect impacts the second effect by interfering with propagation of the stimulation of the second effect.

5. The device of claim 1 wherein the first effect is a blocking effect and the second effect is a hyperpolarization effect, and the first pattern and second pattern are configured to use different subsets of the one or more electrodes to accomplish the first effect and second effect in different volumes of patient tissue.

6. The device of claim 1 wherein the first effect is a subthreshold effect and the second effect is a hyperpolarization effect, and the first pattern and second pattern are configured to use different subsets of the one or more electrodes to accomplish the first effect and second effect in different volumes of patient tissue.

7. The device of claim 1 wherein the first and second effects are selected so as to modulate operation of a neural network of a patient in at least two separate spatial ways.

8. The device of claim 1 wherein the first and second effects are selected so as to modulate operation of a neural network in at least two separate temporal ways.

9. The device of claim 1 wherein the first and second effects are selected so as to modulate activity of a neural network in both temporally and spatially diverse manners.

10. The device of claim 1, taking the form of an implantable neurostimulator comprising a housing containing the operational circuitry, the housing including one or more ports for coupling to an implantable lead having a plurality of stimulus delivery electrodes thereon, the operational circuitry comprising a controller or processor coupled to a memory.

11. The device of claim 1 wherein the operational circuitry is configured to monitor charge delivered during each of the first and second therapy patterns and to then generate one or more asymmetric closing pulses configured to avoid long term polarization of tissue-electrode interfaces of the plurality of electrodes after delivery of one or more iterations of the first and second therapy patterns.

12. The device of claim 11 wherein the operational circuitry is configured to deliver the closing pulse or pulses in a subthreshold manner.

13. The device of claim 11 wherein the operational circuitry is configured to deliver the closing pulse or pulses in a hyperpolarizing manner.

14. A method of operating a neuromodulation device configured for use with one or more electrodes for delivery of neuromodulation signals, and having operational circuitry including therapy delivery circuitry controllable by the operational circuitry, wherein the method comprises delivering the following therapeutic outputs:

a first therapy pattern configured to accomplish a first effect on a patient; and

a second therapy pattern configured to accomplish a second effect on a patient;

the therapy outputs using a plurality of electrodes such that the first effect impacts the second effect; and

wherein the first and second patterns are different from one another insofar as the first therapy pattern is an asymmetric voltage controlled output, and the second therapy pattern is an asymmetric current controlled output.

15. The method of claim 14, wherein the first effect is a subthreshold effect and the second effect is a stimulation effect, and the first pattern and second pattern are delivered by using different subsets of the one or more electrodes to accomplish the first effect and second effect in different volumes of patient tissue.

16. The method of claim 14, wherein the first and second effects are selected so as to modulate operation of a neural network in at least two separate temporal ways.

17. The method of claim 14, wherein the device takes the form of an implantable neurostimulator comprising a housing that contains the operational circuitry and including one or more ports for coupling to an implantable lead having a plurality of stimulus delivery electrodes thereon, the operational circuitry comprising a controller or processor coupled to a memory.

18. The method of claim 14, further comprising monitoring charge delivered during delivery of each of the first and second therapy patterns, and generating one or more asymmetric closing pulses configured to avoid long term polarization of tissue-electrode interfaces of the plurality of electrodes after delivery of one or more iterations of the first and second therapy patterns.

19. The method of claim 18 wherein the closing pulse or pulses is delivered in a subthreshold manner.

20. The method of claim 18 wherein the closing pulse or pulses is delivered in a hyperpolarizing manner.