Systems and methods for assessing the effectiveness of a therapy including a drug regimen using an implantable medical device

Patent metadata

Field	Value
Publication number	US-11064926-B2
Application number	US-201715817160-A
Country	US
Kind code	B2
Filing date	Nov 17, 2017
Priority date	Jul 1, 2011
Publication date	Jul 20, 2021
Grant date	Jul 20, 2021

Abstract

Systems and methods rely on feedback from an active medical device or devices (e.g., neurostimulator coupled to sensing and stimulation elements such as electrodes) to assess the effectiveness of a patient's drug regimen. Such reliance may include analyzing characteristics in physiological data acquired by the medical device(s), for example, in the form of responses evoked from the patient by electrical stimulation waveforms. Systems and methods further involved adjusting one or more parameters according to which a combination therapy consisting of at least a drug regimen and an electrical stimulation therapy are delivered to a patient, in an effort to optimize the therapeutic effect of the combination. The adjustments may be automatically by one or more implanted or external hosts working together or alone, and/or with the input of a physician.

First claim

What is claimed is:

1. A method comprising:
acquiring physiological data from a patient via one or more sensors associated with an implanted medical device;
analyzing with the implanted medical device the acquired physiological data to obtain one or more results;
determining with the implanted medical device that a drug therapy to which the patient is being subjected is either effective or not effective based on a comparison between at least one of the one or more results and a corresponding baseline or target;
in response to determining that the drug therapy is not effective, delivering with the implanted medical device to one or more locations of interest in the patient's central nervous system a form of neuromodulation therapy according to at least one set of programmable neuromodulation parameters, wherein the form of neuromodulation therapy is different from the drug therapy to which the patient is being subjected; and
repeating the acquiring, analyzing, and determining steps with the implanted medical device, and in response to determining that the drug therapy is not effective, adjusting the at least one set of programmable neuromodulation parameters,
wherein the form of neuromodulation therapy is electrical stimulation, the at least one set of programmable neuromodulation parameters comprises a set of electrical stimulation parameters, and adjusting the at least one set of programmable neuromodulation parameters comprises adjusting the set of electrical stimulation parameters based on a mechanism of action associated with the drug therapy.

2. The method of claim 1 , wherein the adjusting is performed by the implanted medical device.

3. The method of claim 1 , further comprising repeating the acquiring, analyzing, determining, delivering, and adjusting steps until the drug therapy is effective or until a predetermined time period has been reached or exceeded.

4. The method of claim 1 , wherein the acquired physiological data includes one or more of: electrographic activity sensed from neural tissue, neurochemical levels, neurotransmitter levels, and extracellular levels of oxygen.

5. The method of claim 1 , wherein the set of electrical stimulation parameters comprises one or more of a phase width, a pulse amplitude, an overall pulse morphology, an inter-phase interval, a number of pulses in a burst, a burst duration, a burst morphology, a duty cycle, and a stimulation pathway through the one or more locations of interest in the patient's central nervous system.

6. The method of claim 1 , wherein the mechanism of action is sodium channel blocker and the adjusting comprises increasing one of a burst duration or a frequency of the set of electrical stimulation parameters.

7. The method of claim 1 , wherein the mechanism of action is GABA or glutamate modulator and the adjusting comprises increasing a burst duration or decreasing a frequency of the set of electrical stimulation parameters.

8. The method of claim 1 , wherein the mechanism of action is mixed and the adjusting comprises decreasing a burst duration or increasing a frequency of the set of electrical stimulation parameters.

9. The method of claim 1 , wherein the mechanism of action is SV2A and the adjusting comprises increasing one of a current amplitude or a voltage amplitude of the set of electrical stimulation parameters, or increasing a pulse width of the set of electrical stimulation parameters.

10. The method of claim 1 , wherein the mechanism of action is dependent on cerebral blood flow, and the adjusting the at least one set of programmable neuromodulation parameters comprises adjusting the set of electrical stimulation parameters to increase local cerebral blood flow.

11. The method of claim 1 , wherein the mechanism of action is dependent on cellular activity, and the adjusting the at least one set of programmable neuromodulation parameters comprises adjusting the set of electrical stimulation parameters to increase local neural activity.

12. The method of claim 1 , wherein the acquired physiological data comprises electrographic activity sensed from neural tissue, the implanted medical device is configured to detect an event in the electrographic activity based on a set of detection parameters, and the one or more results comprises at least one of:
a count of detected events during a time period,
a change in counts of detected events over a plurality of time periods,
a rate of detected events during a time period,
a change in rates of detected events over a plurality of time periods,
a statistical measure of durations of detected events during a time period, and
a change in statistical measures of durations of detected events over a plurality of time periods.

13. The method of claim 1 , wherein the acquired physiological data comprises electrographic activity sensed from neural tissue, the implanted medical device is configured to note an occurrence of a device condition caused by the electrographic activity, and the one or more results comprises at least one of:
a count of occurrences of the device condition during a time period,
a change in counts of occurrences of the device condition over a plurality of time periods,
a rate of occurrences of the device condition during a time period,
a change in rates of occurrences of the device condition over a plurality of time periods,
a statistical measure of durations of occurrences of the device condition during a time period, and
a change in statistical measures of durations of occurrences of the device condition over a plurality of time periods.

14. The method of claim 13 , wherein the device condition corresponds to a saturation of an amplifier of the implanted medical device.

15. The method of claim 1 , wherein the acquired physiological data comprises electrographic activity sensed from neural tissue, the implanted medical device is configured to obtain a measure of power in a frequency band of the electrographic activity, and the one or more results comprises at least one of:
measures of power during a time period, and
a change in measures of power over a plurality of time periods.

16. The method of claim 1 , wherein the acquired physiological data comprises electrographic activity sensed from neural tissue, the implanted medical device is configured to obtain a measure of evoked potential amplitude in the electrographic activity, and the one or more results comprises at least one of:
measures of evoked potential amplitude during a time period, and
a change in measures of evoked potential amplitude over a plurality of time periods.

17. The method of claim 1 , wherein the acquired physiological data comprises extracellular levels of oxygen, the implanted medical device is configured to compare an extracellular level of oxygen to an oxygen threshold, and the one or more results comprises at least one of:
a count of occurrences of the extracellular level of oxygen being below the oxygen threshold during a time period,
a change in counts of the occurrences over a plurality of time periods,
a rate of counts of the occurrences during a time period, and
a change in rates of counts of the occurrences over a plurality of time periods.

18. The method of claim 1 , wherein the acquired physiological data comprises neurochemical levels, the implanted medical device is configured to compare a neurochemical level to a neurochemical threshold, and the one or more results comprises at least one of:
a count of occurrences of the neurochemical level being below the neurochemical threshold during a time period,
a chan

Assignees

• Neuropace Inc

Inventors

• Crowder Tara L
• Wingeier Brett M
• Morrell Martha J
• Sun Felice
• Tcheng Thomas

Classifications

• A61B5/4848 Primary

  Monitoring or testing the effects of treatment, e.g. of medication · CPC title

• A61B5/383 Primary

  Somatosensory stimuli, e.g. electric stimulation · CPC title

• A61B5/0031

  Implanted circuitry · CPC title

• A61B5/4082

  Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette · CPC title

• G16H40/63

  for local operation · CPC title