Discriminating between an awake phase and a sleep phase of a patient in an active implantable medical device

• US 6,773,404 B2
• Filed: 12/05/2002
• Issued: 08/10/2004
• Est. Priority Date: 12/07/2001
• Status: Expired due to Term

• Current Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Ela Medical S.A. (LivaNova Plc)
• Inventors: Limousin, Marcel, Poezevera, Yann
• Primary Examiner(s): Jones, Mary Beth
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US10/310,689
• Publication Number:
  US 20030163059A1
• Time in Patent Office: 614 Days
• Field of Search: 600/534, 600/529, 600/532, 600/533, 600/300, 600/301, 600/481, 600/536, 600/547, 600/544, 600/595
• US Class Current: 600/534
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration

Abstract

An active medical device having an improved discrimination between an awake phase of a patient and a sleep phase of a patient. This device measures a physiological parameter of a patient, delivers a physiological signal with a slow time response variation, in particular a signal of minute-ventilation (signal MV), and detects whether the patient is in a phase of awakening or sleep. An average (VE) of the signal MV is calculated over a given number of respiratory cycle and compared with a predetermined threshold (Threshold MV), such that a first state of awakening is determined when the average is higher than the threshold, and a first state of sleep is determined in the contrary case. The device also measures patient activity (signal G), using a signal having a short response time. The activity signal is compared with a predetermined threshold (Threshold G), and a second state of the patient is determined to be an awakening phase when the activity signal is higher than the threshold, and a sleep state in the contrary case. Detecting the phases of awakening and sleep also includes comparing the first state of awakening/sleep to the second state of awakening/sleep, and in the event of a discordance between these states, the response time of the physiological signal processing is modified, in particular by reducing the number of respiratory cycles over which the average MV signal (VE₁₂₈, VE₆₄) is calculated.

Claims

1. An active medical device, comprising:

(a) means for measuring a physiological parameter of a patient and delivering a physiological signal;

(b) means for detecting an awakening phase and a sleep phase of the patient, including;

a first comparator means for computing an average value of the measured physiological signal over a first period, and comparing said average with a predetermined physiological threshold; and

(c) means for indicating a first state of the patient as an awakening state in response to the average being greater than said physiological threshold, and as a sleep state otherwise;

(d) means for measuring an activity parameter of the patient and producing a physical signal corresponding to said activity parameter;

(e) second comparator means for comparing the measured physical signal with a predetermined activity threshold; and

(f) means for indicating a second state of the patient as an awakening state in response to said activity signal being greater than said activity threshold, and as a sleep state otherwise;

(g) means for comparing the first state of the patient with the second state of the patient; and

(h) anticipating means for selectively modifying the period of said first comparator means in response to a discordance between the aforementioned first and second states of awakening or sleep.

2. The device of claim 1, wherein the physiological parameter measuring means further comprises a minute-ventilation signal and the period comprises a first number of preceding respiratory cycles.

3. The device of claim 1, wherein the period is a first plurality of prior periods and the anticipating means further comprises means for modifying the first plurality of prior periods.

4. The device of claim 3, wherein the anticipating means further comprises means for reducing the first plurality of prior periods to a second plurality less than the first plurality.

5. The device of claim 4, wherein the reducing means further comprises means for reducing the first plurality of prior periods by at least 50%.

6. The device of claim 4, wherein the physiological parameter measuring means further comprises a minute-ventilation signal and the first plurality of periods comprises a first plurality of preceding respiratory cycles.

7. The device of claim 4, further comprising means for determining a trend of the physiological signal as one of a stable, increasing and decreasing trend, wherein the reducing means further comprises means for selectively reducing the first plurality of periods:

in response to the first state being an awakening state, the second state being a sleep state, and a decreasing trend, or

in response to the first state being a sleep state, the second state being an awakening state, and a stable or increasing trend.

8. The device of claim 1, wherein the activity parameter measuring means further comprises an acceleration sensor.

9. The device of claim 1, further comprising means for detecting a respiratory sleep disorder, said means being activated only in response to the first state being a sleep state.

10. The device of claim 9, wherein the sleep respiratory disorder detecting means further comprises means for detecting an apnea and for calculating an apnea index.

11. The device of claim 1, further comprising means for stimulating cardiac activity of a patient as a function of the measured physiological signal.

12. An active implantable medical device, comprising:

(a) a physiological sensor responsive to a physiological parameter of a patient having a first time response and a physiological output signal;

(b) a first a calculator responsive to said physiological output signal, a first period, and a predetermined physiological threshold, said calculator having an output corresponding to an average of successive values of the physiological signal over said period to provide an average physiological signal;

(c) a first state detector indicating a first state of the patient as an awakening state in response to the average physiological signal being greater than the physiological threshold, and as a sleep state otherwise;

(d) a patient activity sensor having a second response time and producing a physical signal output corresponding to an activity of the patient, the second response time being faster than said first response time;

(e) a second state detector for indicating a second state of the patient as an awakening state in response to said activity signal being greater than the activity threshold, and as a sleep state otherwise; and

(f) a comparator responsive to the first state of the patient and the second state of the patient having a first output corresponding to a discordance of said first and second states;

wherein the first calculator response time is modified in response to a discordance between the first and second states of awakening or sleep.

13. The device of claim 12, wherein the physiological sensor further comprises a minute-ventilation sensor and the physiological output signal comprises a minute ventilation signal and the period comprises a first number of preceding respiratory cycles.

14. The device of claim 12, wherein period comprises a number of prior periods and modifying said period comprises reducing said number of prior periods.

15. The device of claim 14, wherein the number of prior periods is reduced by at least 50%.

16. The device of claim 14, wherein the physiological sensor further comprises a minute-ventilation sensor and the physiological output signal comprises a minute ventilation signal and the number of prior periods comprises a number of preceding respiratory cycles.

17. The device of claim 13 further comprising a physiological trend indicator having an output responsive to a trend of the physiological signal over time, said output being one of a stable, increasing or decreasing trend, wherein the number of prior periods is reduced:

in response to the first state being an awakening state, the second state being a sleep state, and a decreasing trend, or

in response to the first state being a sleep state, the second state being an awakening state, and a stable or increasing trend.

18. The device of claim 12, wherein the activity sensor further comprises an acceleration sensor.

19. The device of claim 12, further comprising a respiratory sleep disorder detector that is activated only in response to the first state being a sleep state.

20. The device of claim 19, wherein the sleep respiratory disorder detector further comprises an apnea detector, a timer, and a counter for calculating an apnea index as a number of apneas per hour.