Apparatus, systems, and methods for treating obstructive sleep apnea

• US 9,492,086 B2
• Filed: 11/02/2015
• Issued: 11/15/2016
• Est. Priority Date: 03/21/2012
• Status: Active Grant

• Current Assignee: Fresca Medical, Inc.
• Original Assignee: Fresca Medical, Inc.
• Inventors: Ewers, Richard, Chen, Kevin, Dominguez, Andrew
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US14/930,284
• Publication Number:
  US 20160051791A1
• Time in Patent Office: 379 Days
• Field of Search: 128/204.18, 128/204.23, 128/205.24, 128/205.25, 128/207.18
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/0533 Measuring galvanic skin response
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1118 Determining activity level
• 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
• 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 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0875 Connecting tubes
• 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 2016/003 with a flowmeter
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity

Abstract

Apparatus, systems, and methods are provided for treating obstructive sleep apnea. A unitary valve assembly removably located inside the exterior profile of a nasal pillow mask uses positive airway pressure from a low-flow hose to automatically create an on-demand therapeutic air splint in the pharynx. During inspiration the mask'"'"'s valving system allows room air to be inspired. During exhalation another valve governs therapeutic backpressure equal to the prescribed pressure setting of the CPAP blower machine. The mask may be worn when the CPAP blower machine is off, and systems are provided for turning the CPAP blower machine on only when needed.

Claims

1. A mask for treating a patient suffering from obstructive sleep apnea, the mask adapted to be connected to an air flow generator and constructed to cover at least the nostrils of the patient, the mask comprising:

a cavity in fluid connection with the nostrils of the patient;

an inlet pressure port constructed to be attached to the air flow generator;

the inlet pressure port fluidly connected to the cavity via an inlet pressure one-way valve that is constructed to allow air flow from the air flow generator to the cavity with little resistance and block air flow from the cavity to the air flow generator;

the inlet pressure port fluidly connected to an expiration valve, wherein the expiration valve is fluidly connected to the cavity and to the outside of the mask, the expiration valve restricts air flow from the cavity to the outside of the mask, wherein an opening pressure of the expiration valve is variable and dependent on the pressure of air in the inlet pressure port as follows;

(1) the opening pressure of the expiration valve increases when the pressure or air in the inlet pressure port increases; and

/or (2) the opening pressure of the expiration valve decreases when the pressure or air in the inlet pressure port decreases; and

an inspiration one-way valve fluidly connected to the cavity and to the outside of the mask, the inspiration valve is constructed to allow air flow from the outside of the mask into the cavity with little resistance and block air flow from the cavity to the outside of the mask.

2. The mask of claim 1 further comprising a valve cartridge that comprises the inlet pressure one way valve, the expiration valve and the inspiration one way valve.

3. The mask of claim 2, wherein the cartridge is removable.

4. The mask of claim 1 wherein the inspiration one way valve comprises two valves.

5. The mask of claim 1 further comprising an ambient pressure port, wherein the inspiration one-way valve and the expiration valve are fluidly connected to the ambient port.

6. The mask of claim 1, wherein the inlet pressure one way valve comprises a membrane and a valve seat.

7. The mask of claim 6, wherein the shape of the membrane depends on the pressure of air in the inlet pressure port.

8. The mask of claim 1, wherein the inspiration one way valve comprises a membrane and a valve seat.

9. The mask of claim 1, wherein the expiration valve comprises a membrane and a valve seat.

10. The mask of claim 1, wherein the opening pressure of the expiration valve is substantially zero when the pressure of air in the inlet pressure port is substantially zero.

11. A mask for treating a patient suffering from obstructive sleep apnea, the mask adapted to be connected to an air flow generator and constructed to cover at least the nostrils of the patient, the mask comprising:

a cavity in fluid connection with the nostrils of the patient;

an inlet pressure port constructed to be attached to the air flow generator;

the inlet pressure port fluidly connected to the cavity via an inlet pressure one-way valve;

the inlet pressure port fluidly connected to an expiration valve, wherein the expiration valve is fluidly connected to the cavity and to the outside of the mask, the expiration valve restricts air flow from the cavity to the outside of the mask, wherein an opening pressure of the expiration valve is variable and dependent on the pressure of air in the inlet pressure port as follows;

(1)the opening pressure of the expiration valve increases when the pressure or air in the inlet pressure port increases; and

/or (2) the opening pressure of the expiration valve decreases when the pressure or air in the inlet pressure port decreases;

an inspiration one-way valve fluidly connected to the cavity and to the outside of the mask;

the mask having at least an inspiration mode, a rest/apnea mode and an expiration mode;

the inspiration mode occurs when the patient inspires air, during which the inspiration one-way valve and the inlet pressure one-way valve are open;

the rest/apnea mode occurs when the patient is neither inspiring air nor expiring air, during which the inlet pressure one-way-valve is open, and the expiration valve and inspiration one-way valve are closed; and

the expiration mode occurs when the patient expires air, during which the expiration valve is open and the inlet pressure one-way valve and the inspiration one-way valve are closed.

12. The mask of claim 11, wherein the mask comprises a disconnected mode when the air flow generator is not providing airflow to the mask:

during which when a patient inspires the inspiration one-way valve and the expiration valve are open; and

during which when a patient expires the inspiration one-way valve is closed and the expiration valve is open.

13. The mask of claim 11, wherein the mask comprises a disconnected mode when the air flow generator is not providing airflow to the mask:

during which when a patient inspires the inspiration one-way valve is open; and

during which when a patient expires the inspiration one-way valve is closed and the expiration valve is open.

14. The mask of claim 11, wherein the opening pressure of the expiration valve is substantially zero when the pressure of air in the inlet pressure port is substantially zero.

15. A system for treating a patient suffering from obstructive sleep apnea, system comprising:

an air flow generator, which further comprises a controller that adjusts an air flow pressure and volume to be generated;

a tube connected to the air flow generator;

a mask constructed to cover at least the nostrils of the patient, the mask comprising;

a cavity in fluid connection with the nostrils of the patient;

an inlet pressure port constructed to be attached to the air flow generator via the tube;

the inlet pressure port fluidly connected to the cavity via an inlet pressure one-way valve that is constructed to allow air flow from the air flow generator to the cavity with little resistance and block air flow from the cavity to the air flow generator;

the inlet pressure port fluidly connected to an expiration valve, wherein the expiration valve is fluidly connected to the cavity and to the outside of the mask, the expiration valve restricts air flow from the cavity to the outside of the mask, wherein an opening pressure of the expiration valve is variable and dependent on the pressure of air in the inlet pressure port as follows;

(1) the opening pressure of the expiration valve increases when the pressure or air in the inlet pressure port increases; and

/or (2) the opening pressure of the expiration valve decreases when the pressure or air in the inlet pressure port decreases; and

an inspiration one-way valve fluidly connected to the cavity and to the outside of the mask, the inspiration valve is constructed to allow air flow from the outside of the mask into the cavity with little resistance and block air flow from the cavity to the outside of the mask.

16. The system of claim 15, wherein the controller comprises a delay circuit that delays the generation of air flow from the air flow generator for a predetermined amount of time.

17. The system of claim 16, wherein a predetermined maximum pressure is set and the air flow generator gradually increases the pressure of air generated until the maximum pressure is reached.

18. The system of claim 17, wherein the sleep detector is worn by the patient and is adapted to take biometric readings of the patient.

19. The system of claim 17, wherein the sleep detector is wirelessly connected to the controller.

20. The system of claim 15, further comprising a sleep detector that signals the controller that the patient is asleep, thus activating the generation of air flow from the air flow generator.

21. The system of claim 20, wherein a predetermined maximum pressure is set and the air flow generator gradually increases the pressure of air generated until the maximum pressure is reached.

22. The system of claim 15, wherein the tube consists of a single lumen connecting the mask to the air flow generator.

23. The system of claim 15, wherein the opening pressure of the expiration valve is substantially zero when the pressure of air in the inlet pressure port is substantially zero.