Method and apparatus for the non-invasive detection of particular sleep-state conditions by monitoring the peripheral vascular system

• US 7,806,831 B2
• Filed: 07/16/2002
• Issued: 10/05/2010
• Est. Priority Date: 03/02/2000
• Status: Active Grant

• Current Assignee: Itamar Medical Ltd. (Asahi Kasei Corporation)
• Original Assignee: Itamar Medical Ltd. (Asahi Kasei Corporation)
• Inventors: Sheffy, Jacob, Lavie, Peretz, Pillar, Giora, Schnall, Robert P.
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): Natnithithadha; Navin
• Application Number:
  US10/195,464
• Publication Number:
  US 20030004423A1
• Time in Patent Office: 3,003 Days
• Field of Search: 600/300, 600/301, 600/481, 600/483, 600500-507, 600490-499, 600/323, 600/324, 600/334, 600/340, 600/363, 600/328
• US Class Current: 600/507
• CPC Class Codes: A61B 5/02154 by optical transmission
• CPC Class Codes: A61B 5/02241 of small dimensions, e.g. adapted to fingers
• CPC Class Codes: A61B 5/1073 Measuring volume, e.g. of limbs
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/4393 Sexual arousal or erectile dysfunction evaluation, e.g. tumescence evaluation
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/4812 Detecting sleep stages or cycles

Abstract

Method and apparatus for monitoring the sleep state condition of an individual by using an external probe applied to a peripheral body location, such as the individual'"'"'s finger or toe, for detecting changes in the peripheral vascular bed volume of the individual. A predetermined pressure field is applied to the distal end of the peripheral body location, including its distal-most extremity, to prevent the occurrence of venous pooling within and distal to the peripheral body location. The probe produces an output corresponding to changes in the peripheral arterial bed volume at the peripheral body location, which output provides an indication of the sleep state condition of the individual. Such information is useful in diagnosing and/or in treating, a number of sleep disorders as well as other conditions, such as impotence, diabetes, and various disorders in children.

Claims

1. A method of monitoring an individual for the occurrence of a particular sleep state condition of the individual, comprising:

applying an external probe to an external surface at a peripheral body location on the individual'"'"'s body for monitoring the peripheral vascular bed volume of the individual at said peripheral body location while applying a predetermined pressure field to the distal end of said peripheral body location, including its distal-most extremity, effective to prevent the occurrence of venous pooling within said peripheral body location, and thereby to produce an output from the probe corresponding to changes in the peripheral arterial bed volume at said peripheral body location;

while the individual is in a sleep state, utilizing said probe to detect;

(a) changes in the peripheral vascular bed volume of the individual at said peripheral body location, (b) amplitude changes in the probe output or time changes in the time course of the response pattern of the probe output, and (c) changes in the individual'"'"'s pulse rate or amplitude, and to produce outputs corresponding to such changes;

and determining the sleep state condition of the individual according to such changes detected by said external probe.

2. The method according to claim 1, wherein said pressure field is extended for a distance from said monitoring site towards the heart side of said peripheral body location such as to prevent the occurrence of venous pooling also thereat.

3. The method according to claim 2, wherein said external probe measures changes in the peripheral arterial tone at said peripheral body location.

4. The method according to claim 1, wherein said peripheral body location of the individual is a finger, toe or ear lobe of the individual.

5. The method according to claim 1, wherein said external probe is a volume measuring device.

6. The method according to claim 1, wherein said external probe is an optical density measuring device.

7. The method according to claim 1, wherein said particular condition is an arousal during the sleep state, and is indicated at least by a predetermined attenuation in the probe output.

8. The method according to claim 7, wherein the time intervals between attenuations in the probe output are also used to determine the sleep state condition of the individual.

9. The method according to claim 1, wherein said particular condition is an apnea event and is indicated at least by a predetermined attenuation in the probe output.

10. The method according to claim 1, wherein said particular condition is a hypopnea event and is indicated at least by a predetermined attenuation in the probe output.

11. The method according to claim 1, wherein said particular condition is an upper airway resistance syndrome (UARS) event and is indicated at least by a predetermined attenuation in the probe output.

12. The method according to claim 1, wherein said particular condition is a Cheyne-Stokes breathing pattern and is indicated at least by predetermined attenuations in the probe output.

13. The method according to claim 1, wherein said particular condition is a REM (rapid eye movements) sleep stage condition and is indicated at least by predetermined attenuations in the probe output.

14. The method according to claim 1, wherein the time intervals between attenuations in the probe output are used to distinguish between arousals related to periodic leg movement syndrome (PLMS) and arousals related to disordered breathing events during sleep.

15. The method according to claim 1, wherein the blood oxygen saturation level of the individual is also monitored to produce an output which is used with the output of said external probe to determine the sleep state condition of the individual.

16. The method according to claim 1, wherein, the oral-nasal airflow of the individual is also monitored to produce an output which is used with the output of said external probe to determine the sleep state condition of the individual.

17. The method according to claim 1, wherein, the ECG pulse of the individual is also monitored to produce an output which is used with the output of said external probe to determine the sleep state condition of the individual and particularly the Pulse Transition Time (PTT).

18. The method according to claim 1, wherein:

the individual is an adult male suffering from a functional impotence condition;

while the individual is in said sleep state condition, a penile tumescence or rigidity monitoring device is utilized to also detect nocturnal penile erections and to produce an output corresponding thereto;

and the outputs of said probe and said penile tumescence monitoring device are utilized in determining whether the impotence condition of the individual is more likely due to an organic cause or a psychogenic cause.

19. The method according to claim 1, wherein:

the individual is a diabetic patient and the output of said probe is utilized in indicating the probable occurrence of abrupt changes in the glucose level of the patient.

20. The method according to claim 1, wherein the individual is a child, and the output of said probe is utilized in detecting a potential obstructive sleep apnea (OSA) condition in the child.

21. The method according to claim 1, wherein the individual is a child suffering from Attention Deficit Hyperactive Disorder (ADHD) condition, and the output of said probe is utilized in diagnosing the cause of said AHDH condition of the child.

22. The method according to claim 1, wherein the individual is a child, and the output of said probe is utilized in detecting a silent nocturnal asthma condition in the child.

23. The method according to claim 1, wherein the individual is a child, and the output of said probe is utilized in distinguishing between sleep terrors and nightmares.

24. The method according to claim 1, wherein said peripheral body location of the individual is a superficial skin region of the individual'"'"'s body surface.

25. The method according to claim 1, wherein said predetermined change of the probe output or said predetermined change in the time course of the response pattern of the probe output is derived from a series of pulse waves for determining the sleep state condition of the individual.

26. The method according to claim 1, wherein said predetermined change of the probe output or said predetermined change in the time course of the response pattern of the probe output is derived from the variability of a series of pulse waves for determining the sleep state condition of the individual.

27. The method according to claim 1, wherein said particular condition is arousals or respiratory disorders in a CPAP treated patient.

28. The method according to claim 27, wherein said output of the external probe is also used to differentiate between respiratory and non-respiratory arousals.

29. Apparatus for monitoring an individual to detect the occurrence of a particular condition during the sleep state of the individual, comprising:

an external probe to be applied to an external surface at a peripheral body location on the individual'"'"'s body for monitoring (a) changes in the peripheral vascular bed volume of the individual at said peripheral body location, (b) amplitude changes in the probe output or changes in the time course of the response pattern of the probe output, and (c) changes in the individual'"'"'s pulse rate and amplitude, and for producing outputs corresponding thereto;

said external probe including a pressure applicator for applying a predetermined pressure field to the distal end of said peripheral body location including its distal-most extremity to prevent the occurrence of venous pooling and thereby to produce an output signal from the probe corresponding to changes in the peripheral arterial bed volume at said peripheral body location;

and a processor for processing said outputs from the probe and for producing a signal indicating said particular sleep state condition when a predetermined change in the outputs of said probe is detected.

30. The apparatus according to claim 29, wherein said probe extends said pressure field for a distance from the signaling device towards the heart side of said peripheral body location such as to prevent the occurrence of venous pooling also thereat.

31. The apparatus according to claim 29, wherein said external probe measures changes in the peripheral arterial tone at said peripheral body location.

32. The apparatus according to claim 29, wherein said peripheral body location of the individual is a finger, toe or ear lobe of the individual.

33. The apparatus according to claim 29, wherein said external probe is a volume measuring device capable of providing an index related to volume.

34. The apparatus according to claim 29, wherein said external probe is an optical density measuring device.

35. The apparatus according to claim 29, wherein the apparatus further includes a pulse oximeter for monitoring the blood oxygen saturation level of the individual to produce an output which is used by said processor with said external probe output to indicate the sleep state condition of the individual.

36. The apparatus according to claim 29, wherein the apparatus further includes an oral-nasal airflow sensor for monitoring the oral-nasal airflow of the individual to produce an output which is used by said processor with said external probe output to indicate the sleep state condition of the individual.

37. The apparatus according to claim 29, wherein said individual is an adult male suffering from a functional impotence condition, and said apparatus further comprises:

a penile tumescence or rigidity monitoring device for detecting nocturnal penile erections and for producing an output corresponding thereto, said probe and monitoring device outputs being helpful in diagnosing the cause of said functional impotence condition.

38. The apparatus according to claim 29, wherein said individual is a diabetic patient, and said processor processes the output of said probe to indicate the probable occurrence of abrupt changes in the blood glucose level of the patient.

39. The apparatus of claim 29, further comprising means for activating or de-activating of the said pressure applicator for applying a predetermined pressure field to the distal end of the peripheral body location of the external probe, wherein said activating or de-activating means are situated at the site of the said external probe itself.