# US 11,076,774 B2 · Device with flow rate indicator

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- Number: US 11,076,774 B2
- Document ID: US11076774B2
- Status: Granted
- Kind: B2
- Application number: 16/072,389
- Filed: 2017-02-10
- Published: 2019-03-07
- Granted: 2021-08-03
- Earliest claimed: 2016-02-15
- Assignees: Clement Clarke International Ltd.
- Applicants: Clement Clarke International Ltd.
- Inventors: David Spencer; Ronald Bruin; Mark Sanders
- Web page: https://patentgrep.com/patent/US11076774B2

## CPC

- A61B 5/087: Measuring breath flow
- A61M 15/00: Inhalators {(drug delivery in endotracheal tubes A61M16/04)}
- A61M 15/003: {using capsules, e.g. to be perforated or broken-up}
- A61M 15/0041: {with movable piercing or cutting means}
- A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)}
- A61M 15/0023: {retractable}
- A61M 2202/064: Powder
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/43: making noise when used correctly
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/581: by audible feedback
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}

## Abstract

The present invention provides a patient inhalation/exhalation device such as a spirometer, respiratory inhaler or spacer, the device comprising: at least one aperture for inlet or outlet of air into/from the device; a mouthpiece for communication with the mouth of the patient; and a body defining an air flow path extending between the aperture and the mouthpiece along which air is drawn to the mouthpiece by inhalation by the patient or air is forced towards the aperture by exhalation by the patient. The body comprises an air flow rate indicator operable to generate a sound signal to indicate when the air flow rate along the air flow path is at or above a predetermined minimum level. In another aspect, the present invention provides a device for indicating a desired fluid flow rate along a fluid flow path through a respiratory inhaler. The device comprises an inlet aperture, an outlet aperture for fluid communication with the fluid flow path through the respiratory inhaler, and a body defining a second fluid flow path extending between the inlet aperture and the outlet aperture. The body comprises a connector portion for connection to the respiratory inhaler and a fluid flow rate indicator operable to generate a sound signal to indicate when the fluid flow rate along the second fluid flow path is at a predetermined fluid flow rate. The air flow rate indicators comprise a corrugated portion having at least one or a plurality of corrugations extending into their fluid flow paths.

## Claims

### Claim 1

A device for indicating a desired fluid flow rate along a fluid flow path through a respiratory inhaler, the device comprising:
an inlet aperture;
an outlet aperture for fluid communication with the fluid flow path through the respiratory inhaler; and
a body defining a second fluid flow path extending between the inlet aperture and the outlet aperture, the body comprising:
a connector portion for connection to the respiratory inhaler; and
a fluid flow rate indicator operable to generate a sound signal to indicate when the fluid flow rate along the second fluid flow path is at a predetermined fluid flow rate,
wherein the fluid flow rate indicator comprises a corrugated portion having a plurality of corrugations extending into the second fluid flow path, wherein the corrugated portion comprises a plurality of parallel ridges/peaks spaced by a plurality of curved troughs/furrows which at least partially encircle the second fluid flow path.

### Claim 2 (depends on 1)

A device according to claim 1 wherein the body comprises a substantially tubular channel or substantially tubular body portion defining a substantially tubular second fluid flow path and wherein the corrugated portion is integrally formed with the inner walls of the tubular channel/body portion.

### Claim 3 (depends on 1)

A device according to claim 1 wherein the plurality of ridges/troughs are oriented substantially perpendicularly to the second fluid flow path.

### Claim 4 (depends on 1)

A device according to claim 1 wherein the connector portion has a tubular recess defined by a full or partial tubular sleeve within which the respiratory inhaler may be received and retained and wherein the outlet aperture of the second fluid flow path opens into the recess of the connector portion.

### Claim 5 (depends on 2)

A device according to claim 2 wherein the connector portion is a cap for seating on the respiratory inhaler and for mounting the tubular body portion within the inhaler air flow path.

### Claim 6 (depends on 1)

A device according to claim 1 wherein the body defines a further second fluid flow path extending between a further inlet aperture and a further outlet aperture, and a further fluid flow rate indicator operable to generate a further sound signal to indicate when the fluid flow rate along the further second fluid flow path is at a second predetermined fluid flow rate, wherein the further fluid flow rate indicator comprises a further corrugated portion having at least one corrugation extending into the further second fluid flow path.

### Claim 7 (depends on 1)

A device according to claim 1, the device comprising:
a tubular body portion defining the second fluid flow path extending between the inlet aperture and the outlet aperture, the corrugated portion having at least one corrugation extending into the second fluid flow path within the tubular body portion and a further tubular body portion defining a further second fluid flow path extending between a further inlet aperture and a further outlet aperture, and a further fluid flow rate indicator operable to generate a further sound signal to indicate when the fluid flow rate along the further second fluid flow path is at a second predetermined fluid flow rate, wherein the fluid flow rate indicator comprises a further corrugated portion having at least one corrugation extending into the further second fluid flow path, and wherein the two flow rate indicators have a different number of corrugations and/or the two tubular body portions have different path lengths.

### Claim 8 (depends on 1)

A system comprising a device according to claim 1 and a sound receiver for detecting the sound signal.

### Claim 9 (depends on 8)

A method of monitoring actuation of a respiratory inhaler device for delivery of a drug to a patient, the method comprising:
providing a system according to claim 8,
detecting the sound signal generated when the air flow rate along the air flow path is at or above the predetermined minimum level suitable for delivery of the drug to the patient,
detecting a change in frequency of the sound signal upon actuation of the device by the patient.

### Claim 10

A device for indicating a predetermined fluid flow rate, the device comprising:
an aperture;
a mouthpiece; and
a body defining a fluid flow path extending between the aperture and the mouthpiece, the body comprising a fluid flow rate indicator operable to generate a sound signal to indicate when the fluid flow rate along the fluid flow path is at the predetermined fluid flow rate,
wherein the fluid flow rate indicator comprises a corrugated portion having a plurality of corrugations extending into the fluid flow path, wherein the corrugated portion comprises a plurality of parallel ridges/peaks spaced by a plurality of curved troughs/furrows which at least partially encircle the fluid flow path.

### Claim 11 (depends on 10)

A device according to claim 10 wherein the body and/or corrugated portion is substantially rigid.

### Claim 12 (depends on 10)

A device according to claim 10 wherein the plurality of ridges/troughs are oriented substantially perpendicularly to the fluid flow path.

### Claim 13 (depends on 10)

A device according to claim 10 wherein the device is a patient inhalation/exhalation device and wherein:
the aperture is for inlet or outlet of air into/from the device;
the mouthpiece is for communication with the mouth of the patient;
the fluid flow path is an air flow path extending between the aperture and the mouthpiece along which air is drawn to the mouthpiece by inhalation by the patient or air is forced towards the aperture by exhalation by the patient and the fluid flow rate indicator is an air flow rate indicator operable to generate a sound signal to indicate when the air flow rate along the air flow path is at or above a predetermined minimum level.

### Claim 14 (depends on 13)

A device according to claim 13 wherein the device is a respiratory inhaler device for delivery of a drug to a patient, and wherein:
the aperture is for inlet of air into the device; and
the fluid flow path is an air flow path extending from the aperture to the mouthpiece along which air is drawn to the mouthpiece by inhalation by the patient and the fluid flow rate indicator is an air flow rate indicator operable to generate a sound signal to indicate when the air flow rate along the air flow path is at or above a predetermined minimum level suitable for delivery of the drug to the patient.

### Claim 15 (depends on 14)

A device according to claim 14 wherein the inhaler device further comprises a seat for location of a drug reservoir and the corrugated portion is provided upstream than the seat for location of the drug reservoir.

### Claim 16 (depends on 13)

A device according to claim 13 wherein the device is a spacer or holding chamber for a respiratory inhaler for delivery of a drug to a patient, wherein:
the aperture is adapted to receive a mouthpiece of the respiratory inhaler; and
the fluid flow path is an air flow path extending from the aperture to the mouthpiece of the device along which air is drawn to the mouthpiece of the device by inhalation by the patient and the flow rate indicator is an air flow rate indicator operable to generate a sound signal to indicate when the air flow rate along the air flow path is at or above a predetermined minimum level suitable for delivery of the drug to the patient.

### Claim 17 (depends on 16)

A device according to claim 16 wherein the body is tubular and comprises an axially oriented recess wherein the corrugated portion is provided in the axially-oriented recess.

### Claim 18 (depends on 10)

A system comprising a device according to claim 10 and a sound receiver for detecting the sound signal.
