Obstructive sleep apnea treatment screening methods

Patent metadata

Field	Value
Publication number	US-11081222-B2
Application number	US-201414505151-A
Country	US
Kind code	B2
Filing date	Oct 2, 2014
Priority date	Oct 2, 2013
Publication date	Aug 3, 2021
Grant date	Aug 3, 2021

Abstract

Embodiments include a screening method for evaluating patient suitability for an implanted hypoglossal nerve stimulation (HGNS) device. The screening method evaluates blood oxygen data relating to respiratory events, with the blood oxygen data providing mean blood oxygen desaturation values for comparison to severity thresholds to identify patients who are likely or unlikely to benefit from the implantation of the HGNS device.

First claim

We claim:

1. A method of evaluating and treating a patient using a nerve stimulation device, the method comprising:
receiving, by a server, preconditioned sleep data for analysis, the sleep data including a log of respiratory events for a sleep period of a patient, the sleep data further including blood oxygen data correlated with said respiratory events, wherein the blood oxygen data supports a mean oxygen desaturation value and an oxygen desaturation distribution curve, plotted against desaturation rate, having a slope between two points on the curve;
comparing, by the server, at least one of the mean oxygen desaturation value or the slope of the oxygen desaturation distribution curve with a threshold;
determining, by the server, that the at least one of the mean oxygen desaturation value or the slope of the oxygen desaturation distribution curve is below the threshold;
providing, by the server, an indication that the patient is a candidate for the implantation of the nerve stimulation device to be displayed to a user via a user interface, the indication being based on the determination that the at least one of the mean oxygen desaturation value or the slope of the oxygen desaturation distribution curve is below the threshold;
implanting the nerve stimulation device within the patient based on the indication; and
delivering nerve stimulation therapy to the patient via the nerve stimulation device.

2. The method of claim 1 , wherein the server includes a memory having reference sleep data compiled from a plurality of subjects, wherein the server compares the sleep data of the patient to the sleep data of the plurality of subjects to determine the indication.

3. The method of claim 1 , wherein:
the threshold for the mean oxygen desaturation value is 5%.

4. The method of claim 1 , wherein the server compares the slope to the threshold to determine the indication.

5. The method of claim 4 , wherein the indication is determined based on an absolute value of the slope being below the threshold.

6. The method of claim 1 , wherein the indication further specifies that the patient is one of a strong responder or a borderline responder to the nerve stimulation therapy based on an analysis of the sleep data by the server.

7. The method of claim 1 , wherein the sleep data is received by the server through a website, a mobile application, a software product, or a firmware product.

8. The method of claim 1 , wherein the sleep data is received by the server by a sleep lab, a patient, and/or a user-operated sleep measurement device.

9. The method of claim 1 , wherein the blood oxygen data is at least one of oxygen saturation data, oxygen desaturation data, SpO2 data, SaO2 data, or PaO2 data.

10. The method of claim 1 , wherein:
the threshold for the mean oxygen desaturation value is at least one of 3%, 4%, 5%, 6%, 7%, or 8%.

11. The method of claim 1 , wherein:
the threshold for the mean oxygen desaturation value is at least one of 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%.

12. The method of claim 1 , wherein:
the threshold for the mean oxygen desaturation value is 8%.

13. The method of claim 1 , wherein the threshold is determined based on mean oxygen desaturation values or slopes of oxygen desaturation distribution curves of a plurality of subjects.

14. The method of claim 13 , wherein the plurality of subjects comprises a strong sub-group of subjects and an inadequate sub-group of subjects, the strong sub-group of subjects meeting an improvement criteria upon receiving a stimulation treatment from a nerve stimulation device and the inadequate sub-group of subjects not meeting the improvement criteria upon receiving a stimulation treatment from a nerve stimulation device.

15. A method of evaluating and treating a patient using a nerve stimulation device, the method comprising:
receiving, at a server configured to analyze sleep data, sleep data from a sleep lab, the sleep data including a log of respiratory events for a sleep period of a patient, the sleep data further including blood oxygen data correlated with said respiratory events, wherein the blood oxygen data supports a mean oxygen desaturation value and an oxygen desaturation distribution curve, plotted against desaturation rate, having a slope between two points on the curve;
comparing, by the server, at least one of the mean oxygen desaturation value or the slope of the oxygen desaturation distribution curve with a threshold;
determining, by the server, that the at least one of the mean oxygen desaturation value or the slope of the oxygen desaturation distribution curve is below the threshold;
determining, by the server that the patient is a candidate for the implantation of the nerve stimulation device based on the at least one of the mean oxygen desaturation value or the slope of the oxygen desaturation distribution curve being below the threshold;
providing, by the server, an output based on the sleep data, the output including an indication that the patient is a candidate for the implantation of the nerve stimulation device, wherein the output is configured to be displayed to a user;
implanting the nerve stimulation device within the patient based on the indication; and
delivering nerve stimulation therapy to the patient via the nerve stimulation device.

16. The method of claim 15 , wherein the indication is determined by comparing the sleep data of the patient to reference sleep data compiled from a plurality of subjects.

17. The method of claim 15 , wherein:
the threshold for the mean oxygen desaturation value is 5%.

18. The method of claim 15 , wherein the indication is determined by comparing the slope to the threshold.

19. The method of claim 18 , wherein the indication is determined based on an absolute value of the slope being below the threshold.

20. The method of claim 15 , wherein the indication further specifies that the patient is one of a strong responder or a borderline responder to the nerve stimulation therapy based on an analysis of the sleep data.

21. The method of claim 15 , wherein the sleep data is received from the sleep lab through a website, a mobile application, a software product, or a firmware product.

22. The method of claim 21 , further comprising processing the sleep data received from the sleep lab at the website, the mobile application, the software product, or the firmware product to generate the output.

23. The method of claim 15 , wherein the blood oxygen data is at least one of oxygen saturation data, oxygen desaturation data, SpO2 data, SaO2 data, or PaO2 data.

24. The method of claim 15 , wherein:
the threshold for the mean oxygen desaturation value is at least one of 3%, 4%, 5%, 6%, 7%, or 8%.

25. The method of claim 15 , wherein:
the threshold for the mean oxygen desaturation value is at least one of 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, or 25%.

26. The method of claim 15 , wherein:
the threshold for the mean oxygen desaturation value is 8%.

27. The method of claim 15 , wherein the threshold is determined based on mean oxygen desaturation values or slopes of oxygen desaturation distribution curves of a plurality of subjects.

28. The method of claim 27 , wherein the plurality of subjects comprises a strong sub-group of subjects and an

Assignees

• Livanova Usa Inc

Inventors

• Hoegh Thomas B
• Parrish Daniel A

Classifications

• G16H50/30

  for calculating health indices; for individual health risk assessment · CPC title

• A61B5/7275

  Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor · CPC title

• G01N33/80

  involving blood groups or blood types {or red blood cells (white blood cells G01N33/56972)} · CPC title

• A61B5/7282

  Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818) · CPC title

• G01N33/49

  Blood {(chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80)} · CPC title