# US 2009/0260628 A1 · Multipurpose therapeutic face mask

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- Number: US 2009/0260628 A1
- Document ID: US20090260628A1
- Status: Published application
- Kind: A1
- Application number: 12/423,615
- Filed: 2009-04-14
- Published: 2009-10-22
- Earliest claimed: 2008-04-16
- Inventors: Stephen Donald Flynn, SR.
- Web page: https://patentgrep.com/patent/US20090260628A1

## CPC

- A61M 16/06: Respiratory or anaesthetic masks
- A61M 16/0078: {Breathing bags}
- A61M 16/0816: {Joints or connectors}
- A61M 16/0833: {T- or Y-type connectors, e.g. Y-piece}
- A61M 16/105: {Filters (A61M16/047, A61M16/22 take precedence; water traps A61M16/08)}
- A61M 16/1065: {in the expiratory path}
- A61M 16/107: {in the inspiratory path}
- A61M 16/14: by mixing different fluids, one of them being in a liquid phase
- A61M 16/206: {Capsule valves, e.g. mushroom, membrane valves}
- A61M 16/208: {Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves}
- A61M 11/02: operated by air {or other gas} pressure applied to the liquid {or other product} to be sprayed or atomised {(sprayers for horticulture A01G, A01H; killing insects A01M; air humidifying by nozzles F24F6/14, F24F6/18; cooling by spraying F28B, F28C)}
- A61M 11/06: of the injector type
- A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)}
- A61M 2202/0208: Oxygen
- A62B 9/02: Valves {(non-return valves mounted in breathing masks or helmets A62B18/10)}
- 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)}
- A62B: DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING (valves specially adapted for medical use A61M39/00; life-saving devices, apparatus or methods specially adapted for use in water B63C9/00; divers' equipment B63C11/00; specially adopted for use with aircraft, e.g. parachutes, ejector seats, {B64D17/00, B64D25/10}; rescue devices peculiar to mining E21F11/00)

## Abstract

A therapeutic face mask comprises a face-engaging portion and a single connector having a mask-engaging end and a single treatment-receiving end which has a single attachment mounting for detachably sealingly receiving a treatment attachment, such as an oxygen reservoir bag or a nebulizer. A one-way inhalation valve in the connector permits fluid flow from the treatment-receiving end to the mask-engaging end during inhalation and inhibits fluid flow in the other direction. The mask also includes a valve-governed exhalation port and an anti-asphyxia valve assembly configured to permit fluid flow from ambient to the face-engaging portion during inhalation only when inspiratory effort during inhalation exceeds fluid flow to the treatment-receiving end of the connector. Also provided is an oxygen reservoir bag having a neck shaped for removable coupling to a mating connector of a therapeutic face mask. An oxygen reservoir bag may have a metered-dose inhaler port defined in its neck.

## Claims

### Claim 1

A therapeutic face mask, comprising:
a face-engaging portion having a fluid aperture;
only a single connector, the connector having a mask-engaging end and a only a single treatment-receiving end, the connector defining a fluid passageway between the mask-engaging end and the treatment-receiving end thereof, wherein:
the mask-engaging end of the connector is coupled to the face-engaging portion in fluid communication with the fluid aperture;
the connector has only a single attachment mounting for detachably sealingly receiving a treatment attachment in fluid communication therewith, the attachment mounting being defined at the treatment-receiving end of the connector; and
the connector has at least one inhalation valve interposed in the fluid passageway between the mask-engaging end and the treatment-receiving end thereof, each inhalation valve being a one-way valve and being oriented to permit fluid flow from the treatment-receiving end to the mask-engaging end during inhalation and to inhibit fluid flow from the mask-engaging end to the treatment-receiving end;
at least one an anti-asphyxia valve assembly configured to permit fluid flow therethrough from ambient to the face-engaging portion during inhalation only when fluid flow to the treatment-receiving end of the connector is less than inspiratory effort during inhalation; and
at least one valve-governed exhalation port in fluid communication with the face-engaging portion and positioned to define an exhalation path from the face-engaging portion to ambient which bypasses the inhalation valve and which permits fluid flow from the face-engaging portion to ambient during exhalation and inhibits fluid flow from ambient to the face engaging portion at least when fluid flow to the treatment-receiving end of the connector exceeds inspiratory effort during inhalation.

### Claim 2 (depends on 1)

The therapeutic face mask of claim 1, wherein a single exhalation port is defined in a side wall of the connector and is in fluid communication with the face-engaging portion by way of the fluid passageway.

### Claim 3 (depends on 1)

The therapeutic face mask of claim 1, wherein each exhalation port is defined in the connector and is in fluid communication with the face-engaging portion by way of the fluid passageway, and wherein each exhalation port is positioned between the inhalation valve and the mask-engaging end of the connector.

### Claim 4 (depends on 3)

The therapeutic face mask of claim 3, wherein each exhalation port has a filter mounting for detachably sealingly receiving a filter assembly.

### Claim 5 (depends on 3)

The therapeutic face mask of claim 3, wherein each anti-asphyxia valve assembly is associated with a corresponding exhalation port.

### Claim 6 (depends on 5)

The therapeutic face mask of claim 5, wherein each anti-asphyxia valve assembly comprises a single anti-asphyxia valve disposed in the corresponding exhalation port and oriented to:
permit fluid flow from the connector to ambient through the exhalation port during exhalation; and
permit fluid flow from ambient to the connector through the exhalation port during inhalation only when fluid flow to the treatment-receiving end of the connector is less than inspiratory effort during inhalation.

### Claim 7 (depends on 6)

The therapeutic face mask of claim 6, wherein each exhalation port has a filter mounting for detachably sealingly receiving a filter assembly.

### Claim 8 (depends on 6)

The therapeutic face mask of claim 6, wherein each anti-asphyxia valve comprises an aperture having a single cross member extending thereacross, and a flexible diaphragm secured to the cross member on an outer side of the cross member relative to the fluid passageway.

### Claim 9 (depends on 1)

The therapeutic face mask of claim 1, wherein the connector includes a valve assembly, the connector comprising:
a first passage adjacent the mask-engaging end of the connector, from which first passage fluid can flow into the face-engaging portion and which can also receive fluid from an interior of the face-engaging portion;
a second passage adjacent the treatment-receiving end of the connector; and
the valve assembly, wherein the valve assembly comprises:
a single inhalation valve, the inhalation valve being associated with the first passage and the second passage, the inhalation valve being operable to permit fluid flow from the second passage to the first passage and inhibit fluid flow from the first passage to the second passage;
the exhalation port, which includes a one-way exhalation valve associated with the first passage and operable to permit fluid flow from the first passage to ambient and to inhibit fluid flow from ambient to the first passage; and
the anti-asphyxia valve assembly, which includes a one-way anti-asphyxia valve associated with the first passage and operable to inhibit fluid flow from the first passage to ambient and to permit fluid flow from ambient to the first passage when fluid flow into the second passage is less than inspiratory effort during inhalation;
wherein the inhalation valve comprises a disk-like diaphragm located between the first and second passages and movable between open and closed positions;
one of the exhalation valve and the anti-asphyxia valve comprises an annular diaphragm surrounding the disk-like diaphragm of the inhalation valve and movable between open and closed positions; and
wherein the exhalation port comprises at least one aperture closable by the exhalation valve.

### Claim 10 (depends on 9)

The therapeutic face mask of claim 9, further comprising an oxygen reservoir bag detachably secured to the treatment-receiving end of the connector.

### Claim 11 (depends on 9)

The therapeutic face mask of claim 9, further comprising a medication supplying nebulizer detachably secured to the treatment-receiving end of the connector.

### Claim 12 (depends on 9)

The therapeutic face mask of claim 9, further comprising an annular filter having a central aperture, the annular filter being positioned in the valve assembly to:
filter fluid flow from the first passage through the exhalation port to ambient; and
permit unfiltered fluid flow from the second passage to the first passage through the central aperture.

### Claim 13

A method of preparing a therapeutic face mask configured for oxygen administration for administration of inhaled medication to a patient while the face-engaging portion is engaged with the patient's face, comprising the steps of:
removing from the therapeutic face mask an oxygen reservoir bag that is detachably secured to the therapeutic face mask in fluid communication with a face-engaging portion of the therapeutic face mask, while the face-engaging portion remains engaged with the patient's face and a filter associated with the therapeutic face mask filters air exhaled by the patient; and
detachably securing a nebulizer to the therapeutic face mask in place of the oxygen reservoir bag so that the nebulizer is in fluid communication with the face-engaging portion of the therapeutic face mask while the face-engaging portion remains engaged with the patient's face and the filter associated with the therapeutic face mask filters air exhaled by the patient.

### Claim 14 (depends on 13)

The method of claim 13, wherein:
the step of removing from the therapeutic face mask an oxygen reservoir bag that is detachably secured to the therapeutic face mask comprises removing the oxygen reservoir bag from a treatment-receiving end of a connector having a mask-engaging end and a treatment-receiving end and wherein the mask-engaging end of the connector is coupled to the face-engaging portion in fluid communication with an fluid aperture of the face-engaging portion and the treatment-receiving end of the connector has an attachment mounting for detachably sealingly receiving a treatment attachment in fluid communication therewith so as to define a fluid passageway between the treatment attachment and the fluid aperture and the connector has an inhalation valve interposed in the fluid passageway between the mask-engaging end and the treatment-receiving end thereof, the inhalation valve being a one-way valve and being oriented to permit fluid flow from the treatment-receiving end through the mask-engaging end and to inhibit fluid flow from the mask-engaging end through the treatment-receiving end, and at least one exhalation port is in fluid communication with the face-engaging portion; and
wherein the step of detachably securing a nebulizer to the therapeutic face mask in place of the oxygen reservoir bag comprises detachably securing the nebulizer to the treatment-receiving end of the connector.

### Claim 15

A method of preparing a therapeutic face mask configured for administration of inhaled medication to a patient for oxygen administration while the face-engaging portion is engaged with the patient's face, comprising the steps of:
removing from the therapeutic face mask a nebulizer that is detachably secured to the therapeutic face mask in fluid communication with a face-engaging portion of the therapeutic face mask, while the face-engaging portion remains engaged with the patient's face and a filter associated with the therapeutic face mask filters air exhaled by the patient; and
detachably securing an oxygen reservoir bag to the therapeutic face mask in place of the nebulizer so that the oxygen reservoir bag is in fluid communication with the face-engaging portion of the therapeutic face mask while the face-engaging portion remains engaged with the patient's face and the filter associated with the therapeutic face mask filters air exhaled by the patient.

### Claim 16 (depends on 15)

The method of claim 15, wherein:
the step of removing from the therapeutic face mask a nebulizer that is detachably secured to the therapeutic face mask comprises removing the nebulizer from a treatment-receiving end of a connector having a mask-engaging end and a treatment-receiving end and wherein the mask-engaging end of the connector is coupled to the face-engaging portion in fluid communication with a fluid aperture of the face-engaging portion and the treatment-receiving end of the connector has an attachment mounting for detachably sealingly receiving a treatment attachment in fluid communication therewith so as to define a fluid passageway between the treatment attachment and the fluid aperture and the connector has an inhalation valve interposed in the fluid passageway between the mask-engaging end and the treatment-receiving end thereof, the inhalation valve being a one-way valve and being oriented to permit fluid flow from the treatment-receiving end through the mask-engaging end and to inhibit fluid flow from the mask-engaging end through the treatment-receiving end, and at least one exhalation port is in fluid communication with the face-engaging portion; and
wherein the step of detachably securing an oxygen reservoir bag to the therapeutic face mask in place of the nebulizer comprises detachably securing the nebulizer to the treatment-receiving end of the connector.

### Claim 17

An oxygen reservoir bag, comprising:
a flexible oxygen reservoir bag member;
a valveless neck having a tube attachment member in fluid communication with an interior volume of the neck;
the oxygen reservoir bag member being sealingly secured to a lower end portion of the neck so that an interior volume of the oxygen reservoir bag member is in fluid communication with the interior volume of the neck;
the neck being shaped for removable coupling of an open upper end portion thereof to and in fluid communication with a mating connector of a therapeutic face mask.

### Claim 18

A connector for a therapeutic face mask, the connector having:
a mask-engaging end securable to a face-engaging portion of the therapeutic face mask in fluid communication with a fluid aperture of the face-engaging portion;
a treatment-receiving end;
a fluid passageway defined between the mask-engaging end and the treatment-receiving end;
only a single attachment mounting for detachably sealingly receiving a treatment attachment in fluid communication with the fluid passageway, the attachment mounting being defined at the treatment-receiving end;
at least one inhalation valve interposed in the fluid passageway between the mask-engaging end and the treatment-receiving end of the connector, each inhalation valve being a one-way valve and being oriented to permit fluid flow from the treatment-receiving end through the mask-engaging end during inhalation and to inhibit fluid flow from the mask-engaging end through the treatment-receiving end; and
at least one an anti-asphyxia valve assembly configured to permit fluid flow therethrough from ambient to the face-engaging portion during inhalation only when fluid flow to the treatment-receiving end of the connector is less than inspiratory effort during inhalation.

### Claim 19 (depends on 18)

The connector of claim 18, further comprising at least one valve-governed exhalation port in fluid communication with the face-engaging portion and positioned to define an exhalation path from the face-engaging portion to ambient which bypasses the inhalation valve and which permits fluid flow from the face-engaging portion to ambient during exhalation and inhibits fluid flow from ambient to the face engaging portion at least when fluid flow to the treatment-receiving end of the connector exceeds inspiratory effort during inhalation.

### Claim 20 (depends on 19)

The connector of claim 19, wherein each anti-asphyxia valve assembly is associated with a corresponding exhalation port.

### Claim 21 (depends on 22)

The connector of claim 22, wherein each anti-asphyxia valve assembly comprises a single anti-asphyxia valve disposed in the corresponding exhalation port and oriented to:
permit fluid flow from the connector to ambient through the exhalation port during exhalation; and
permit fluid flow from ambient to the connector through the exhalation port during inhalation only when fluid flow to the treatment-receiving end of the connector is less than inspiratory effort during inhalation.

### Claim 22 (depends on 21)

The connector of claim 21, wherein the exhalation port has a filter mounting for detachably sealingly receiving a filter assembly.

### Claim 23 (depends on 21)

The connector of claim 21, wherein each anti-asphyxia valve comprises an aperture having a single cross member extending thereacross, and a flexible diaphragm secured to the cross member on an outer side of the cross member relative to the fluid passageway.

### Claim 24 (depends on 18)

The connector of claim 18, wherein the connector includes a valve assembly, the connector comprising:
a first passage adjacent the mask-engaging end of the connector, from which first passage fluid can flow into the face-engaging portion and which can also receive fluid from an interior of the face-engaging portion;
a second passage adjacent the treatment-receiving end of the connector; and
the valve assembly, wherein the valve assembly comprises:
a single inhalation valve, the inhalation valve being associated with the first passage and the second passage, the inhalation valve being operable to permit fluid flow from the second passage to the first passage and inhibit fluid flow from the first passage to the second passage;
an exhalation port, which includes a one-way exhalation valve associated with the first passage and operable to permit fluid flow from the first passage to ambient and to inhibit fluid flow from ambient to the first passage; and
the anti-asphyxia valve assembly, which includes a one-way anti-asphyxia valve associated with the first passage and operable to inhibit fluid flow from the first passage to ambient and to permit fluid flow from ambient to the first passage when fluid flow into the second passage is less than inspiratory effort during inhalation;
wherein the inhalation valve comprises a disk-like diaphragm located between the first and second passages and movable between open and closed positions;
one of the exhalation valve and the anti-asphyxia valve comprises an annular diaphragm surrounding the disk-like diaphragm of the inhalation valve and movable between open and closed positions; and
wherein the exhalation port comprises at least one aperture closable by the exhalation valve.

### Claim 25 (depends on 24)

The connector of claim 24, further comprising an annular filter having a central aperture, the annular filter being positioned in the valve assembly to:
filter fluid flow from the first passage through the exhalation port to ambient; and
permit unfiltered fluid flow from the second passage to the first passage through the central aperture.

### Claim 26

An oxygen therapy face mask, comprising:
a face-engaging portion having an inlet passage through which oxygen from a pressurized source can be received;
a valve assembly connected to the inlet passage having a first one-way valve operable to permit flow of oxygen from a source thereof to a patient and inhibit flow in the opposite direction, the valve assembly also having an inlet/outlet passage with a two-way valve permitting ambient air to flow to the patient and permitting exhaled air to flow from the patient to the ambient atmosphere.

### Claim 27 (depends on 26)

The oxygen therapy face mask of claim 26, wherein the valve assembly has a first tubular inlet portion to which an oxygen reservoir bag may be detachably connected, the first tubular inlet portion also being capable of detachably receiving, in the absence of the oxygen reservoir bag, a medication supplying nebulizer, whereby medication can be supplied by the nebulizer through the one-way valve into the face-engaging portion for passage to the patient.

### Claim 28 (depends on 27)

The oxygen therapy face mask of claim 27, wherein the inlet/outlet passage has a tubular portion connecting the two-way valve with the ambient atmosphere, the tubular portion being capable of detachably receiving a filter assembly operable to filter air passing from the ambient atmosphere to the two-way valve and from the two-way valve to the ambient atmosphere.

### Claim 29 (depends on 26)

The oxygen therapy face mask of claim 26, wherein the inlet/outlet passage has a tubular portion connecting the two-way valve with the ambient atmosphere, the tubular portion being capable of detachably receiving a filter assembly operable to filter air passing from the ambient atmosphere to the two-way valve and from the two-way valve to the ambient atmosphere.

### Claim 30 (depends on 26)

The oxygen therapy face mask of claim 26, wherein the two-way valve comprises a rod-like support member extending across the inlet/outlet passage and a diaphragm mounted on the support member and having a closed position blocking air flow through the inlet/outlet valve, the diaphragm being bendable by air pressure from either side thereof to enable air to flow through the valve from the higher pressure side of the diaphragm to the lower pressure side thereof.

### Claim 31 (depends on 27)

The oxygen therapy face mask of claim 27, wherein the two-way valve comprises a rod-like support member extending across the inlet/outlet passage and a diaphragm mounted on the support member and having a closed position blocking air flow through the inlet/outlet valve, the diaphragm being bendable by air pressure from either side thereof to enable air to flow through the valve from the higher pressure side of the diaphragm to the lower pressure side thereof.

### Claim 32 (depends on 28)

The oxygen therapy face mask of claim 28, wherein the two-way valve comprises a rod-like support member extending across the inlet/outlet passage and a diaphragm mounted on the support member and having a closed position blocking air flow through the inlet/outlet valve, the diaphragm being bendable by air pressure from either side thereof to enable air to flow through the valve from the higher pressure side of the diaphragm to the lower pressure side thereof.

### Claim 33 (depends on 29)

The oxygen therapy face mask of claim 29, wherein the two-way valve comprises a rod-like support member extending across the inlet/outlet passage and a diaphragm mounted on the support member and having a closed position blocking air flow through the inlet/outlet valve, the diaphragm being bendable by air pressure from either side thereof to enable air to flow through the valve from the higher pressure side of the diaphragm to the lower pressure side thereof.

### Claim 34

An oxygen reservoir bag, comprising:
a flexible oxygen reservoir bag member;
a neck having an open upper portion end portion and a tube attachment member in fluid communication with an interior volume of the neck;
the oxygen reservoir bag member being sealingly secured to a lower end portion of the neck so that an interior volume of the oxygen reservoir bag member is in fluid communication with the interior volume of the neck;
a metered dose inhaler port defined in the neck, the metered dose inhaler port comprising:
an inner channel defined in the neck in fluid communication with the interior volume of the neck;
an outer channel defined in the neck in fluid communication with ambient;
wherein:
the inner and outer channels are in fluid communication with one another;
the outer channel is larger than the inner channel to define a shoulder between the inner and outer channel; and
the inner channel is angled toward the oxygen reservoir bag member.

### Claim 35 (depends on 34)

The oxygen reservoir bag of claim 34, wherein the neck is valveless and is shaped for removable coupling of the bag to a mating connector of a therapeutic face mask.

### Claim 36 (depends on 34)

The oxygen reservoir bag of claim 34, wherein the inner channel and the outer channel are cylindrical and are coaxial with one another, so that the shoulder is an annular shoulder.