# US 7,607,432 B2 · Apparatus and method for the treatment of an upper airway flow limitation

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- Number: US 7,607,432 B2
- Document ID: US7607432B2
- Status: Granted
- Kind: B2
- Application number: 11/373,125
- Filed: 2006-03-13
- Published: 2006-07-13
- Granted: 2009-10-27
- Earliest claimed: 1999-04-23
- Assignees: Australian Centre for Advanced Medical Technology Ltd.
- Inventors: Colin Sullivan
- Web page: https://patentgrep.com/patent/US7607432B2

## CPC

- A61M 16/024: {including calculation means, e.g. using a processor}
- A61M 2016/0039: {in the inspiratory circuit}
- A61M 2205/50: with microprocessors or computers
- A61M 2230/04: Heartbeat characteristics, e.g. ECG, blood pressure modulation
- A61M 2230/10: Electroencephalographic signals
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

An apparatus and a method for the treatment of an upper airway flow limitation, the apparatus including a means to detect an interruption in an upper airway inspiratory flow rate of the patient and further including a treatment means which treats the upper airway flow limitation on detection of the interruption cycle.

## Claims

### Claim 1

An apparatus for the treatment of an upper airway flow limitation in a patient, the apparatus including:
(a) a means to detect at least one interruption cycle in an upper airway inspiration flow rate of the patient wherein the interruption cycle is characterized by a decrease in upper airway inspiratory flow rate followed by an increase in the upper airway inspiratory flow rate; and
(b) a treatment means which treats the upper airway flow limitation on detection of said at least one interruption cycle in the upper airway inspiratory flow rate.

### Claim 2 (depends on 1)

The apparatus of claim 1 wherein the detection means is adapted to detect a plurality of interruption cycles.

### Claim 3 (depends on 1)

The apparatus of claim 1 when used in the treatment of hypertension caused by pre-eclampsia.

### Claim 4 (depends on 1)

The apparatus of claim 1 wherein the means to detect the at least one interruption cycled includes a means for measuring vibrations in a patient's airway.

### Claim 5 (depends on 4)

The apparatus of claim 4 wherein the means to detect the at least one interruption cycle further includes a means for identifying those measured airway vibrations which indicate an upper airway flow limitation.

### Claim 6 (depends on 1)

The apparatus of claim 1 wherein the means to detect the at least one interruption cycle includes a flow rate measurement means which measures the air flow intake rate in the airway of the patient.

### Claim 7 (depends on 1)

The apparatus of claim 1 wherein the treatment means is a device which applied continuous positive airway pressure to the airway of the patient.

### Claim 8

An apparatus for the treatment of hypertension caused by pre-eclampsia, the apparatus including:
(a) a flow rate measurement means which measures an air flow intake rate in an airway of a patient;
(b) a means to detect at least one interruption cycle in an upper airway inspiration flow rate of the patient wherein the interruption cycle is characterized by a decrease in upper airway inspiratory flow rate followed by an increase in the upper airway inspiratory flow rate; and
(c) a treatment means which treats an upper airway flow limitation in the patient in response to detecting an interruption cycle in the air flow intake rate, said interruption cycle characterized by a decrease in the air flow intake rate followed by an increase in the airflow intake rate so as to alleviate hypertension caused by pre-eclampsia.

### Claim 9

An apparatus for the treatment of hypertension caused by pre-eclampsia, the apparatus including:
(a) a measuring means for measuring airway vibrations in the patient;
(b) identification means which identifies those measured airway vibrations which are indicative of an interruption cycle in an upper airway;
(c) a means to detect at leas one interruption cycle in an upper airway inspiration flow rate of the patient wherein the interruption cycle is characterized by a decrease in upper airway inspiratory flow rate followed by an increase in the upper airs ay inspiratory flow rate; and
(d) treatment means which treats the upper airway flow limitation in the patient upon detection of the interruption cycle.

### Claim 10 (depends on 9)

The apparatus of claim 9 when used for the treatment of hypertension caused by pre-eclampsia.

### Claim 11 (depends on 9)

The apparatus of claim 9 wherein airway vibrations in the frequency range of about 0.2 to about 10 Hz are identified by the identification means as indicative of the upper airway flow limitation.

### Claim 12 (depends on 9)

The apparatus of claim 9 wherein airway vibrations in the frequency range of about 0.5 to about 5 Hz are identified by the identification means as indicative of the upper airway flow limitation.

### Claim 13 (depends on 9)

The apparatus of claim 9 wherein the identification means is capable of generating a signal representative of the breathing cycle of the patient.

### Claim 14 (depends on 13)

The apparatus of claim 13 wherein the identification means includes a comparator means which compares the signal representative of the breathing cycle with a signal representative of the airway vibrations and produces an output signal representative of the comparison.

### Claim 15 (depends on 9)

The apparatus of claim 9 wherein the measuring means is selected from the group consisting of a pressure detector comprising a piezoelectric transducer and an accelerometer comprising an integrated circuit containing a floating piezoelectric transducer.

### Claim 16 (depends on 15)

The apparatus of claim 15 wherein the pressure detector or accelerometer is placed on or under a bed on which a patient sleeps.

### Claim 17 (depends on 16)

The apparatus of claim 16 wherein a further pressure detector or accelerometer is attached to the bed frame or incorporated into a pillow.

### Claim 18 (depends on 15)

The apparatus of claim 15 wherein the pressure detector or accelerometer is attached to a hearing aid placed in an ear of the patient.

### Claim 19 (depends on 15)

The apparatus of claim 15 wherein the measuring means is a pressure detector comprising a piezoelectric transducer and further wherein the pressure detector comprises one or a plurality of sheets of piezoelectric plastic material.

### Claim 20 (depends on 19)

The apparatus of claim 19 wherein the piezoelectric plastic material is attached to a firm rubber or plastic backing sheet.

### Claim 21 (depends on 19, 20)

The apparatus of claim 19 or 20 wherein the pressure detector detects both sub-audible vibrations of the patient's airway and low frequency movements of the breathing cycle of the patient.

### Claim 22 (depends on 1, 8, 9)

The apparatus of claim 1, claim 8 or claim 9 wherein the treatment means has two modes of treatment, a first treatment mode when the patient is awake and a second treatment mode when the patient is asleep.

### Claim 23 (depends on 22)

The apparatus of claim 22 herein, in the first treatment mode, a relatively minimally intrusive continuous positive airway pressure is delivered to the airway of the patient.

### Claim 24 (depends on 22)

The apparatus of claim 22 wherein, in the second treatment mode, a relatively higher continuous positive airway pressure is delivered to the airway of the patient than in the first treatment mode, the continuous positive airway pressure being set so as to be sufficient to treat the upper airway flow limitation in the patient.

### Claim 25 (depends on 22)

The apparatus of claim 22 wherein the treatment means further includes a sleep sensor which determines whether the patient is asleep or awake.

### Claim 26 (depends on 25)

The apparatus of claim 25 wherein the sleep sensor emits a signal upon sensing whether the patient is asleep or upon sensing that the patient is awake.

### Claim 27 (depends on 26)

The apparatus of claim 26 wherein the treatment means further includes a switching means and whereupon receiving a signal from the sleep sensor, the switching means causes the treatment means to switch from one treatment mode to the other treatment mode.

### Claim 28 (depends on 25)

The apparatus of claim 25 wherein the sleep sensor senses that the patient is asleep when there is a reduced average airflow into the airway of the patient.

### Claim 29 (depends on 28)

The apparatus of claim 28 wherein the sleep sensor further includes a movement detector which detects the respiration effort in the patient.

### Claim 30 (depends on 29)

The apparatus of claim 29 wherein the sleep sensor senses that the patient is asleep when there is a reduced respiration effort in the patient.

### Claim 31 (depends on 25)

The apparatus of claim 25 wherein the sleep sensor includes an electrocardiograph.

### Claim 32

A method of treating an upper airway flow limitation in a patient including the steps of:
(a) detecting at least one interruption cycle in an upper airway respiratory flow rate of the patient wherein the interruption cycle is characterized by a decrease in upper airway inspiratory flow rate followed by an increase in the upper airway inspiratory flow rate; and
(b) treating the upper airway flow limitation on detection of an interruption cycle in the upper airway inspiratory flow rate.

### Claim 33 (depends on 32)

The method of claim 32 wherein the detecting step comprises detecting a plurality of interruption cycles in the upper airway inspiratory flow rate.

### Claim 34 (depends on 32, 33)

The method of claim 32 or claim 33 wherein hypertension caused by pre-eclampsia is treated.

### Claim 35

A method of treating a patient for hypertension caused by pre-eclampsia, the method including the steps of: measuring an air flow intake rate in an airway of the patient in response to an interruption cycle in the air flow intake rate, said interruption cycle characterized by a decrease in the airflow intake rate followed by an increase in the airflow intake rate so as to alleviate hypertension caused by pre-eclampsia.

### Claim 36

A method of treating a patient for hypertension caused by pre-eclampsia, the method including the steps of:
(a) measuring airway vibrations in the patient;
(b) identifying those measured airway vibrations which are indicative of an interruption cycle in an upper airway, where the interruption is characterized by a decrease in upper airway inspiratory flow rate followed by an increase in the upper airway inspiratory flow rate; and
(c) on identification of the interruption cycle in an upper airway, treating the upper airway flow limitation in the patient.

### Claim 37 (depends on 36)

The method of claim 36 wherein airway vibrations identified in the frequency range of about 0.2 to about 10 Hz are taken as indicative of the upper airway flow limitation.

### Claim 38 (depends on 36)

The method of claim 36 wherein airway vibrations identified in the frequency range of about 0.5 to about 5 Hz are taken as indicative of the upper airway flow limitation.

### Claim 39 (depends on 36)

The method of claim 36 further including a step of identifying movements indicative of the breathing cycle of the patient.

### Claim 40 (depends on 39)

The method of claim 39 further including the step of comparing movements indicative of the breathing cycle with the measured airway vibrations.

### Claim 41 (depends on 32, 35, 36)

The method of claim 32 or 35 or 36 wherein the step of treating the upper airway flow limitation includes applying continuous positive airway pressure to the airway of the patient.

### Claim 42 (depends on 41)

The method of claim 41 wherein the step of treating the patient is carried out in two modes, a first treatment mode when the patient is awake and a second treatment mode when the patient is asleep.

### Claim 43 (depends on 42)

The method of claim 42 further including the step of determining whether the patient is asleep or awake.

### Claim 44 (depends on 43)

The method of claim 43 further including the step of switching between the two modes of treatment upon determining whether the patient is asleep or awake.

### Claim 45 (depends on 44)

The method of claim 44 wherein whether the patient is asleep or awake is determined by the average airflow into the airway of the patient and further wherein a reduced average airflow in the airway of the patient indicates that the patient is sleeping.

### Claim 46 (depends on 43)

The method of claim 43 wherein whether the patient is asleep or awake is determined by the respiration effort of the patient and further wherein a reduced respiration effort indicates that the patient is asleep.

### Claim 47 (depends on 43)

The method of claim 43 wherein whether the patient is awake or asleep is determined by analysis of an electrocardiogram of the patient.
