# US 10,765,830 B2 · Sleep apnea treatment system and improvements thereto

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- Number: US 10,765,830 B2
- Document ID: US10765830B2
- Status: Granted
- Kind: B2
- Application number: 16/034,980
- Filed: 2018-07-13
- Published: 2019-01-17
- Granted: 2020-09-08
- Earliest claimed: 2017-07-13
- Assignees: Fresca Medical, Inc.
- Applicants: Fresca Medical Inc.
- Inventors: Richard Ewers; Andrew Dominguez
- Web page: https://patentgrep.com/patent/US10765830B2

## CPC

- A61M 16/201: {Controlled valves}
- A61B 5/4818: {Sleep apnoea}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61M 16/0003: {Accessories therefor, e.g. sensors, vibrators, negative pressure}
- A61M 16/206: {Capsule valves, e.g. mushroom, membrane valves}
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature}
- A61B 5/0531: Measuring skin impedance
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/1118: {Determining activity level}
- A61B 5/4809: {Sleep detection, i.e. determining whether a subject is asleep or not}
- A61M 16/0066: {Blowers or centrifugal pumps}
- 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)}
- A61M 16/204: {used for inhalation control}
- A61M 16/205: {used for exhalation control}
- A61M 2016/0027: {pressure meter}
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2230/06: Heartbeat rate only
- 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)

## Abstract

A valve structure for treating a patient suffering from obstructive sleep apnea is provided. The valve structure is connected to an air flow generator and connected to a mask that covers at least the nostrils of a patient. The valve structure includes a housing with an inlet pressure port connected to the air flow generator, and an ambient pressure port. Within the housing is an expiratory membrane, an expiratory valve seat, an inspiratory membrane, an inlet pressure valve seat, an inspiratory valve seat, and an inspiratory membrane segmentation structure configured to segment the movement of the inspiratory membrane into at least a first portion and a second portion. An expiratory valve in fluid connection with the inlet pressure port is formed by the expiratory membrane and the expiratory valve seat. An inlet pressure valve is formed by the inlet pressure valve seat and the first portion of the inspiratory membrane. An inspiratory valve is formed by the inspiratory valve seat and the second portion of the inspiratory membrane.

## Claims

### Claim 1

A valve structure for treating a patient suffering from obstructive sleep apnea, the valve structure adapted to be connected to an air flow generator and connected to a mask that covers at least the nostrils of a patient, the valve structure comprising:
a housing with an inlet pressure port configured to be connected to the air flow generator, and an ambient pressure port, within the housing: an expiratory membrane, an expiratory valve seat, an inspiratory membrane, an inlet pressure valve seat, an inspiratory valve seat, and an inspiratory membrane segmentation structure configured to segment the movement of the inspiratory membrane into at least a first portion and a second portion;
an expiratory valve in fluid connection with the inlet pressure port, formed by the expiratory membrane and the expiratory valve seat;
an inlet pressure valve formed by the inlet pressure valve seat and the first portion of the inspiratory membrane, wherein the inlet pressure valve is constructed to allow air flow from the inlet pressure port into the mask with little resistance and to block air flow from within the mask to the inlet pressure port; and
an inspiratory valve formed by the inspiratory valve seat and the second portion of the inspiratory membrane, wherein the inspiratory valve is constructed to allow air flow from the ambient pressure port into the mask with little resistance and to block air flow from within the mask to the ambient pressure port.

### Claim 2 (depends on 1)

The valve structure of claim 1, wherein the expiratory valve seat is integrally formed into the housing.

### Claim 3 (depends on 1)

The valve structure of claim 1, wherein the inlet pressure valve seat is integrally formed into the housing.

### Claim 4 (depends on 1)

The valve structure of claim 1, wherein the housing defines a housing center axis, wherein the expiratory membrane is substantially planar and oriented substantially orthogonal to the housing center axis and the inspiratory membrane is substantially planar and oriented substantially orthogonal to the housing center axis.

### Claim 5 (depends on 4)

The valve structure of claim 4, wherein the expiratory membrane comprises an expiratory membrane center axis that is substantially coincident with the housing center axis.

### Claim 6 (depends on 4)

The valve structure of claim 4, wherein the inspiratory membrane comprises an inspiratory membrane center axis that is substantially coincident with the housing center axis.

### Claim 7 (depends on 1)

The valve structure of claim 1, wherein the inspiratory membrane segmentation structure further segments the movement of the inspiratory membrane into at least a third portion and a fourth portion, the valve structure further comprising:
a second inlet pressure valve formed by a second inlet pressure valve seat and the third portion of the inspiratory membrane, wherein the second inlet pressure valve is constructed to allow air flow from the inlet pressure port into the mask with little resistance and to block air flow from within the mask to the inlet pressure port; and
a second inspiratory valve formed by a second inspiratory valve seat and the fourth portion of the inspiratory membrane, wherein the second inspiratory valve is constructed to allow air flow from the ambient pressure port into the mask with little resistance and to block air flow from within the mask to the ambient pressure port.

### Claim 8 (depends on 7)

The valve structure of claim 7, wherein the second inlet pressure valve seat and the second inspiratory valve seat are integrally formed into the housing.

### Claim 9 (depends on 1)

The valve structure of claim 1, having at least an inspiration mode, a rest/apnea mode and an expiration mode, wherein:
the inspiration mode occurs when the patient inspires air, during which the inspiration valve and the inlet pressure valve are open, and the expiratory membrane forms a seal with the expiratory valve seat;
the rest/apnea mode occurs when the patient is neither inspiring air nor expiring air, during which the inlet pressure valve is open, the expiratory membrane forms a seal with the expiratory valve seat, and the inspiration valve is closed; and
the expiration mode occurs when the patient expires air, during which the expiratory valve is open, and the inlet pressure valve and the inspiration valve are closed.

### Claim 10 (depends on 1)

The valve structure of claim 1, wherein the valve structure comprises a disconnected mode when the air flow generator is not providing air flow to the valve structure:
during which, when a patient inspires, the inspiration valve opens; and
during which, when a patient expires, the inspiration valve is closed.