Systems and methods for monitoring autonomic health

Patent metadata

Field	Value
Publication number	US-10188353-B2
Application number	US-201615273302-A
Country	US
Kind code	B2
Filing date	Sep 22, 2016
Priority date	Sep 22, 2015
Publication date	Jan 29, 2019
Grant date	Jan 29, 2019

Abstract

A system for monitoring autonomic health may include an autonomic nerve stimulation (ANS) dose delivery system and a response extractor. The response extractor may be configured to record physiological parameter values including first population data that includes evoked response (ER) values corresponding to evoked physiological responses, and second population data that includes reference values that include no effect (NE) values corresponding to times without a physiological response. The response monitor may calculate evoked response metrics (ERMs) using the first and second population data where each of the ERMs may be dependent on background autonomic activity. The response extractor may analyze the ERMs to provide ERM analysis, and provide an indication of autonomic health using the ERM analysis.

First claim

What is claimed is:

1. A method, comprising:
delivering an autonomic neural stimulation (ANS) dose over a plurality of burst periods, including delivering a burst stimulation pulses within a portion of each burst period to evoke physiological responses and not delivering stimulation pulses within another portion of each burst period;
recording physiological parameter values, including:
recording first population data, the first population data including evoked response (ER) values corresponding to the evoked physiological responses to the burst of stimulation pulses for the plurality of burst periods; and
recording second population data, the second population data including reference values that include no effect (NE) values corresponding to times without an evoked physiological response;

calculating evoked response metrics (ERMs) using the first and second population data, each of the ERMs being dependent on background autonomic activity;
analyzing the ERMs to provide ERM analysis; and
providing an indication of autonomic health using the ERM analysis.

2. The method of claim 1 , wherein analyzing the ERMs includes comparing the ERMs to at least one reference value to provide the ERM analysis used to provide the indication of autonomic health.

3. The method of claim 1 , wherein analyzing the ERMs includes trending the ERMs to provide the ERM analysis used to provide the indication of autonomic health.

4. The method of claim 1 , wherein the ER values include:
stimulation effect (SE) values corresponding to direct responses to delivered stimulation pulses; or
reflex effect (RE) values corresponding to reflex responses after delivered stimulation pulses; or
both SE values and RE values.

5. The method of claim 1 , wherein delivering the ANS dose includes delivering bursts of neural stimulation pulses, the NE values including values during times between successive bursts of neural stimulation pulses.

6. The method of claim 1 , wherein the physiological parameter values include at least one of: heart rate values or heart rate variability values.

7. The method of claim 1 , wherein the physiological parameter values include at least one of: respiratory values or respiratory variability values.

8. The method of claim 1 , wherein the physiological parameter values include at least one of: blood pressure values or blood pressure variability values.

9. The method of claim 1 , wherein recording physiological parameter values includes recording electrocardiograms (ECGs), and calculating ERMs includes calculating ERMs using a statistical analysis of at least one feature of the ECGs.

10. The method of claim 1 , wherein calculating ERMs includes:
Z-scoring groups of recorded physiological parameter values to obtain Z-scores for each of the groups; or
T-scoring groups of recorded physiological parameter values to obtain T-scores for each of the groups.

11. The method of claim 1 , wherein delivering the ANS dose includes delivering neural stimulation to a vagus nerve.

12. The method of claim 1 , wherein delivering the ANS dose includes delivering neural stimulation to a carotid sinus nerve or a glossopharyngeal nerve.

13. The method of claim 1 , wherein delivering the ANS dose includes delivering neural stimulation to a baroreceptor region or to a chemoreceptor region.

14. A method, comprising:
delivering a vagal nerve stimulation (VNS) dose over a plurality of burst periods, the VNS dose including a plurality of stimulation bursts, each stimulation burst including a plurality of neural stimulation pulses within a portion of each burst period and another portion of each period does not include neural stimulation pulses;
sensing heart rate and recording heart rate values, including:
recording first population data, the first population data including evoked response (ER) values corresponding to the evoked heart rate effects to stimulation bursts for the plurality of burst periods; and
recording second population data, the second population data including reference values that include no effect (NE) values corresponding to heart rate values that are not evoked heart rate responses to stimulation bursts;

calculating evoked response metrics (ERMs) to quantify a relationship between the first population data and the second population data, each of the ERMs being dependent on background sympathetic activity;
analyzing the ERMs to provide ERM analysis; and
providing an indication of autonomic health using the ERM analysis.

15. The method of claim 14 , further comprising adjusting the ANS dose in steps, calculating an ERM for each step and comparing the ERM to a reference value to monitor autonomic health.

16. The method of claim 14 , wherein analyzing the ERMs includes comparing the ERMs to at least one reference value to provide the ERM analysis used to provide the indication of autonomic health.

17. The method of claim 14 , wherein analyzing the ERMs includes trending the ERMs to provide the ERM analysis used to provide the indication of autonomic health.

18. The method of claim 14 , further comprising detecting a patient status or a patient condition, and tagging the ERMs with the detected patient status or condition.

19. The method of claim 14 , wherein:
the ER values in the first population data include stimulation effect (SE) values corresponding to direct responses to stimulation bursts; and
calculating ERMs includes analyzing for a SE signature.

20. The method of claim 14 , wherein:
the ER values in the first population data include reflex effect (RE) values corresponding to reflex responses after stimulation bursts; and
calculating the ERM to quantify the relationship between the first population data and the second population data includes analyzing for a RE signature.

Assignees

• Cardiac Pacemakers Inc

Inventors

• Stolen Craig
• Ruble Stephen B
• Agarwal Rahul
• Wold Nicholas

Classifications

• A61B5/33

  specially adapted for cooperation with other devices · CPC title

• A61B5/0816

  Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00) · CPC title

• A61N1/36117

  for treating hypertension · CPC title

• A61N1/0456

  Specially adapted for transcutaneous electrical nerve stimulation [TENS] · CPC title

• A61N1/36114

  Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362) · CPC title