Auto-feedback valve for a sleep apnea device

• US 10,307,562 B2
• Filed: 05/15/2014
• Issued: 06/04/2019
• Est. Priority Date: 04/13/2012
• Status: Expired due to Fees

• Current Assignee: Fresca Medical, Inc.
• Original Assignee: Fresca Medical, Inc.
• Inventors: Cragg, Andrew H., Logan, John, Nissimov, Haim, Ewers, Richard Christian, Adler, Mark Alan, Chen, Eugene G., Trusheim, John Edwin, Nolting, John Eugene, Anderson, Stephen William, Chen, Kevin Nai Hong
• Primary Examiner(s): Anderson, Gregory A
• Assistant Examiner(s): Luarca, Margaret M
• Application Number:
  US14/278,587
• Publication Number:
  US 20140246025A1
• Time in Patent Office: 1,846 Days
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0688 by means of an adhesive
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/0866 Passive resistors therefor
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/201 Controlled valves
• CPC Class Codes: A61M 16/202 electrically actuated
• CPC Class Codes: A61M 16/206 Capsule valves, e.g. mushroom, membrane valves
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 16/209 Relief valves
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2016/0661 : with customised shape
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/42 : Reducing noise
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2205/8237 : Charging means
• CPC Class Codes: A61M 2205/8281 : spring operated
• CPC Class Codes: A61M 2209/06 : Packaging for specific medical equipment
• CPC Class Codes: A61M 2209/088 : on the body
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/18 : Rapid eye-movements [REM]
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity
• CPC Class Codes: Y10T 29/49412 : with assembly, disassembly or composite article making

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

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.

2. 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.

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

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

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

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

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

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.

9. 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.