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-12029581-B2
Application number	US-202117346944-A
Country	US
Kind code	B2
Filing date	Jun 14, 2021
Priority date	Jul 1, 2011
Publication date	Jul 9, 2024
Grant date	Jul 9, 2024

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. An implantable medical device configured for implant in a patient's brain and for assessing an effectiveness of an existing drug regimen to which the patient is subjected, the implantable medical device comprising:
one or more electrodes configured for implant at a first location in the patient's brain or on a surface of the patient's brain; and
a neurostimulator coupled to the one or more electrodes and configured to:
deliver electrical stimulation therapy through the one or more electrodes according to a set of stimulation parameters,
continuously sense electrical activity of the patient's brain through the one or more electrodes,
detect epileptiform events in an electrographic signal corresponding to the sensed electrical activity,
detect evoked responses in the electrographic signal, and calculate, in response to a detection of an evoked response, a measure of the evoked response,
detect a presence of a specified frequency band in the electrographic signal, and calculate, in response to a detection of the specified frequency, a power measure of the electrographic signal in the specified frequency,
log information as a function of time, the logged information comprising one or more of a count of occurrences of the epileptiform events, durations of the epileptiform events, measures of the evoked responses, and power measures of the electrographic signal in the specified frequency,
determine a tracked metric based on changes in the logged information over a time period within which the existing drug regimen, if effective, would affect the tracked metric,
determine the existing drug regimen is not effective responsive to the tracked metric not satisfying a criterion relative to a corresponding baseline metric, and
responsive to a determination that the existing drug regimen is not effective, adjust the set of stimulation parameters based on a mechanism of action of a drug of the existing drug regimen.

2. The implantable medical device of claim 1 , wherein the criterion is satisfied when the tracked metric is within a specified range of the corresponding baseline metric, or the tracked metric does not exceed the corresponding baseline metric.

3. The implantable medical device of claim 1 , wherein the corresponding baseline metric is based on an electrographic signal sensed from the patient prior to a start of the existing drug regimen, and the criterion is satisfied when the tracked metric is a threshold value different from the corresponding baseline metric.

4. The implantable medical device of claim 1 , wherein the corresponding baseline metric corresponds to a preset metric determined independent of an electrographic signal sensed from the patient.

5. The implantable medical device of claim 1 , wherein the neurostimulator is further configured to output a signal when the criterion is not satisfied, and the signal is configured to indicate an adjustment to one or more parameters of the existing drug regimen for display on a user interface of an external device.

6. The implantable medical device of claim 5 , wherein the one or more parameters of the existing drug regimen comprise a drug, a type of the drug, a dosage of the drug, a class of the drug, a method of delivery of the drug, and a timing of delivery of the drug.

7. The implantable medical device of claim 1 , wherein the neurostimulator is further configured to generate a signal when the criterion is not satisfied, and the signal is configured to implement a change to the existing drug regimen.

8. The implantable medical device of claim 7 , further comprising an implantable drug-eluting lead operating in accordance with drug regimen parameters programmed in the neurostimulator, and wherein the signal is configured to change one or more of the drug regimen parameters.

9. The implantable medical device of claim 7 , further comprising a stimulation module configured to deliver electrical stimulation to the one or more electrodes in accordance with a plurality of stimulation parameters programmed in the implantable medical device, and wherein the signal is configured to change one or more of the plurality of stimulation parameters.

10. The implantable medical device of claim 1 , wherein the epileptiform events correspond to a long episode and the logged information comprises a duration of the long episode that is based on a start time of the long episode and an end time for the long episode.

11. The implantable medical device of claim 1 , wherein the neurostimulator is configured to log information without storing a record of the electrographic signal.

12. The implantable medical device of claim 1 , further comprising a stimulation module configured to periodically deliver an evoked-response electrical stimulation to one or more electrodes configured for implant at a second location in the patient's brain or on a surface of the patient's brain, wherein the evoked-response electrical stimulation is configured to produce an evoked response in the electrographic signal.

13. The implantable medical device of claim 12 , wherein the first location and the second location are a same location.

14. The implantable medical device of claim 12 , wherein the first location and the second location are different locations.

15. The implantable medical device of claim 1 , wherein the measure of the evoked response is an amplitude.

16. The implantable medical device of claim 1 , wherein the time period is at least 24 hours.

17. A method of assessing an effectiveness of an existing drug regimen to which a patient with an implanted medical device is subjected, the method comprising:
delivering, by the implanted medical device, electrical stimulation therapy to the patient's brain according to a set of stimulation parameters;
continuously sensing, by the implanted medical device, electrical activity of the patient's brain;
detecting, by the implanted medical device, epileptiform events in an electrographic signal corresponding to the sensed electrical activity;
detecting, by the implanted medical device, evoked responses in the electrographic signal, and calculating, in response to a detection of an evoked response, a measure of the evoked response;
detecting, by the implanted medical device, a presence of a specified frequency band in the electrographic signal, and calculating, in response to a detection of the specified frequency, a power measure of the electrographic signal in the specified frequency;
logging, by the implanted medical device, information as a function of time, the logged information comprising one or more of a count of occurrences of the epileptiform events, durations of the epileptiform events, measures of the evoked responses, and power measures of the electrographic signal in the specified frequency;
determining, by the implanted medical device, a tracked metric based on changes in the logged information over a time period within which the existing drug regimen, if effective, would affect the tracked metric;
determining, by the implanted medical device, the existing drug regimen is not effective responsive to the tracked metric not satisfying a criterion relative to a corresponding baseline metric; and
responsive to determining that the existing drug regimen is not effective, adjusting, by the implanted medical device, the set of stimulation parameters based on a mechanism of action of a drug of the existing drug regimen.

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

• A61B5/0022

  Monitoring a patient using a global network, e.g. telephone networks, internet · CPC title

• A61B5/4094

  Diagnosing or monitoring seizure diseases, e.g. epilepsy · CPC title