# US 10,307,562 B2 · Auto-feedback valve for a sleep apnea device

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- Number: US 10,307,562 B2
- Document ID: US10307562B2
- Status: Granted
- Kind: B2
- Application number: 14/278,587
- Filed: 2014-05-15
- Published: 2014-09-04
- Granted: 2019-06-04
- Earliest claimed: 2012-04-13
- Assignees: Fresca Medical, Inc.
- Applicants: Fresca Medical, Inc.
- Inventors: Andrew H. Cragg; John Logan; Haim Nissimov; Richard Christian Ewers; Mark Alan Adler; Eugene G. Chen; John Edwin Trusheim; John Eugene Nolting; Stephen William Anderson; Kevin Nai Hong Chen
- Web page: https://patentgrep.com/patent/US10307562B2

## CPC

- A61M 16/208: {Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves}
- A61B 5/11: Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb {(A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721)}
- A61B 5/4809: {Sleep detection, i.e. determining whether a subject is asleep or not}
- A61B 5/4818: {Sleep apnoea}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61M 16/0057: {Pumps therefor}
- A61M 16/06: Respiratory or anaesthetic masks
- A61M 16/0683: {Holding devices therefor}
- A61M 16/0833: {T- or Y-type connectors, e.g. Y-piece}
- A61M 16/0866: {Passive resistors therefor}
- A61M 16/0875: {Connecting tubes}
- A61M 16/201: {Controlled valves}
- A61M 16/206: {Capsule valves, e.g. mushroom, membrane valves}
- A61M 16/0069: {the speed thereof being controlled by respiratory parameters, e.g. by inhalation}
- A61M 16/0688: {by means of an adhesive}
- A61M 16/107: {in the inspiratory path}
- A61M 16/202: {electrically actuated}
- A61M 16/209: {Relief valves}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0039: {in the inspiratory circuit}
- A61M 2016/0661: {with customised shape}
- A61M 2205/18: with alarm
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/42: Reducing noise
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/8206: battery-operated
- A61M 2205/8237: Charging means
- A61M 2205/8281: spring operated
- A61M 2209/06: Packaging for specific medical equipment
- A61M 2209/088: on the body
- A61M 2230/04: Heartbeat characteristics, e.g. ECG, blood pressure modulation
- A61M 2230/18: Rapid eye-movements [REM]
- A61M 2230/205: partial oxygen pressure (P-O2)
- A61M 2230/63: Motion, e.g. physical activity
- Y10T 29/49412: with assembly, disassembly or composite article making
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A device for treating a patient suffering from obstructive sleep apnea or snoring can include an expiratory valve connected to a manifold. The expiratory valve can include a body portion including a feedback port configured to be connected to an air flow generator. The expiratory valve can include a plunger at least partially disposed in the body portion. The expiratory valve can include a pressurizing chamber positioned between an end of the plunger and an end of the expiratory valve. The pressurizing chamber can be configured to receive air from the air flow generator through the feedback port.

## Claims

### Claim 1

A system for treating a patient suffering from obstructive sleep apnea or snoring, the system comprising:
a manifold;
an air flow generator connected to the manifold and configured to deliver an air flow at a positive therapeutic pressure during the treatment and transition between an off condition and an on condition;
an expiratory valve connected to the manifold comprising an open pressure that is dependent on the therapeutic pressure from the air flow generator, the expiratory valve further comprises:
a membrane with a surface that experiences the therapeutic pressure:
a plunger on the opposite side of the surface, the plunger forming a seal;
a magnet that magnetically biases the plunger against the seal, thereby closing the expiratory valve;
wherein when the expiratory valve opens the plunger contacts the membrane;
wherein the expiratory valve exerts a back pressure upon each exhalation from the patient sufficient to create a pneumatic splint in the patient's respiratory tract, the back pressure comprised of the therapeutic pressure and the magnetic bias;
wherein the exhalation from the patient has a first half followed by a second half and the back pressure is varied such that during the start of the first half the back pressure is between 0 and 50% of a peak back pressure and increases to a peak back pressure in the second half; and
at least one inspiratory one-way valve connected to the manifold to provide air flow at a therapeutic pressure from the air flow generator to the patient;
wherein plunger is constructed with a weight of less than 1.7 grams such that the expiratory valve experiences substantially the same open pressure irrespective of the expiratory valve's orientation relative to the gravity vector.

### Claim 2 (depends on 1)

A method of using the system of claim 1, comprising:
going to sleep when the air flow generator is in the off condition;
transitioning the air flow generator from the off condition to the on condition after a period of time.

### Claim 3 (depends on 2)

The method of claim 2, wherein a user sets the period of time.

### Claim 4 (depends on 2)

The method of claim 2, further comprising sensing when the patient is asleep.

### Claim 5 (depends on 4)

The method of claim 4, wherein the airflow generator transitions to the on condition after the system detects that the patient is asleep.

### Claim 6 (depends on 4, 5)

The method of claim 4 or 5, wherein sensing when the patient is asleep comprises detecting movement using an accelerometer.

### Claim 7 (depends on 1)

The system of claim 1 wherein the plunger has a wall thickness of less than 0.005 in.

### Claim 8

A system for treating a patient suffering from obstructive sleep apnea or snoring, the system comprising:
a manifold;
an air flow generator connected to the manifold and configured to deliver an air flow at a positive therapeutic pressure during the treatment and transition between an off condition and an on condition;
an expiratory valve connected to the manifold comprising an open pressure that is dependent on the therapeutic pressure from the air flow generator, the expiratory valve further comprises:
a membrane with a surface that experiences the therapeutic pressure, wherein the membrane has an elasticity;
a plunger on the opposite side of the surface, the plunger forming a seal and having a weight;
a magnet that magnetically biases the plunger against the seal, thereby closing the expiratory valve;
wherein when the expiratory valve opens the plunger contacts the membrane;
wherein the expiratory valve exerts a back pressure upon each exhalation from the patient sufficient to create a pneumatic splint in the patient's respiratory tract, the back pressure comprised of the therapeutic pressure and the magnetic bias;
wherein the exhalation from the patient has a first half followed by a second half and the back pressure is varied such that during the start of the first half the back pressure is between 0 and 50% of a peak back pressure and increases to a peak back pressure in the second half; and
at least one inspiratory one-way valve connected to the manifold to provide air flow at a therapeutic pressure from the air flow generator to the patient;
wherein the plunger weight, the membrane elasticity and the magnetic bias are selected to create an opening pressure of less than 2.0 CM of H2O when the airflow generator is not delivering air flow to the expiatory valve.

### Claim 9 (depends on 8)

The system of claim 8, wherein the plunger weight, the membrane elasticity and the magnetic bias are further selected such that the expiratory valve experiences substantially the same open pressure irrespective of the expiratory valve's orientation relative to the force of gravity.