# US 10,369,304 B2 · Flow regulating inhaler device

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- Number: US 10,369,304 B2
- Document ID: US10369304B2
- Status: Granted
- Kind: B2
- Application number: 15/362,883
- Filed: 2016-11-29
- Published: 2017-05-04
- Granted: 2019-08-06
- Earliest claimed: 2014-06-30
- Assignees: Syqe Medical Ltd.
- Applicants: Syqe Medical Ltd.
- Inventors: Perry Davidson; Aaron Schorr; Binyamin Schwartz
- Web page: https://patentgrep.com/patent/US10369304B2

## CPC

- A61M 15/0028: {using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up}
- A61B 5/087: Measuring breath flow
- A61K 9/007: {Pulmonary tract; Aromatherapy}
- A61K 9/0073: {Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; (nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M)}
- A61K 31/465: Nicotine; Derivatives thereof
- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 36/3482: {Cannabis}
- A61K 36/81: Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61M 11/041: {using heaters}
- A61M 11/042: {electrical}
- A61M 15/0001: {Details of inhalators; Constructional features thereof}
- A61M 15/0003: {with means for dispensing more than one drug}
- A61M 15/0013: {with inhalation check valves}
- A61M 15/0015: {located upstream of the dispenser, i.e. not traversed by the product}
- A61M 15/002: {with air flow regulating means}
- A61M 15/0045: {using multiple prepacked dosages on a same carrier, e.g. blisters}
- A61M 15/005: {the dosages being arranged on a cylindrical surface}
- A61M 15/0051: {the dosages being arranged on a tape, e.g. strips}
- A61M 15/0065: {Inhalators with dosage or measuring devices (A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52)}
- A61M 15/0066: {with means for varying the dose size}
- A61M 15/06: Inhaling appliances shaped like cigars, cigarettes or pipes
- A61M 16/14: by mixing different fluids, one of them being in a liquid phase
- A61M 16/20: Valves specially adapted to medical respiratory devices
- A61M 16/201: {Controlled valves}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/08: for nausea, cinetosis or vertigo; Antiemetics
- A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 9/12: Antihypertensives
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- A61P 13/10: of the bladder
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/04: Antipruritics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 25/08: Antiepileptics; Anticonvulsants
- A61P 25/14: for treating abnormal movements, e.g. chorea, dyskinesia
- A61P 25/16: Anti-Parkinson drugs
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A61P 25/20: Hypnotics; Sedatives
- A61P 25/22: Anxiolytics
- A61P 25/24: Antidepressants
- A61P 25/30: for treating abuse or dependence
- A61P 25/32: Alcohol-abuse
- A61P 27/06: Antiglaucoma agents or miotics
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- A61P 31/14: for RNA viruses
- A61P 31/18: for HIV
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- H05B 1/025: {For medical applications}
- A61B 5/4833: {Assessment of subject's compliance to treatment}
- A61B 2560/028: Arrangements to prevent overuse, e.g. by counting the number of uses
- A61B 2562/0247: Pressure sensors
- 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 15/0021: {Mouthpieces therefor}
- A61M 15/0091: {mechanically breath-triggered}
- A61M 16/0009: {with sub-atmospheric pressure, e.g. during expiration}
- A61M 16/0066: {Blowers or centrifugal pumps}
- A61M 16/024: {including calculation means, e.g. using a processor}
- A61M 16/204: {used for inhalation control}
- A61M 16/208: {Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves}
- A61M 2016/0021: {with a proportional output signal, e.g. from a thermistor}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0039: {in the inspiratory circuit}
- A61M 2202/04: Liquids
- A61M 2202/064: Powder
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M 2205/07: having air pumping means
- A61M 2205/3303: Using a biosensor
- A61M 2205/3313: used specific wavelengths
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/36: related to heating or cooling
- A61M 2205/43: making noise when used correctly
- A61M 2205/44: making noise when used incorrectly
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- A61M 2205/583: by visual feedback
- A61M 2205/7545: for solid matter, e.g. microaggregates
- A61M 2206/11: Laminar flow
- A61M 2206/18: Coaxial flows, e.g. one flow within another
- A61M 2230/40: Respiratory characteristics
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- H05B: ELECTRIC HEATING; ELECTRIC LIGHT SOURCES NOT OTHERWISE PROVIDED FOR; CIRCUIT ARRANGEMENTS FOR ELECTRIC LIGHT SOURCES, IN GENERAL

## Abstract

An inhaler device for pulmonary delivery of at least one substance from a drug dose cartridge to an inhaling user, including: a first conduit for conducting a carrier airflow to a proximal opening of a mouthpiece for use by the user; a holder configured to position the dose cartridge within the carrier airflow; and a second conduit for conducting a shunting airflow to the mouthpiece without passing through the dose cartridge position. In some embodiments, a controller connected to a valve controls a rate of carrier airflow, for example by controlling the shunting airflow, based on a sensor indication of airflow rate and a target airflow profile.

## Claims

### Claim 1

An inhaler device for delivering to a user at least one drug substance emitted from a dose cartridge, the inhaler device comprising:
a heater assembly positioned to heat a source material comprising a drug substance, said source material contained within said dose cartridge;
a holder configured to hold said dose cartridge at a dose cartridge position in which said at least one drug substance released from said dose cartridge enters a carrier airflow; wherein at least 90% of said carrier airflow is directed to pass through said source material within said dose cartridge, carrying said at least one drug substance away from said source material once said source material is heated by said heater assembly;
wherein said heater assembly is positioned in proximity to said dose cartridge or incorporated therein when said dose cartridge is held by said holder;
a first conduit for conducting said carrier airflow from said dose cartridge position to an opening through which the user inhales;
at least one valve positioned and configured to affect said carrier airflow;
at least one sensor positioned and configured for detecting at least one parameter indicating a rate of said carrier airflow; and
a controller configured to control, by affecting said at least one valve, a rate of said carrier airflow through said source material within said dose cartridge based on said at least one parameter obtained by said sensor;
wherein said controller controls said valve and said heater assembly to deliver a predetermined amount of drug substance based on the varying incoming carrier airflow sensed by said at least one sensor.

### Claim 2 (depends on 1)

The inhaler device according to claim 1, wherein said controller is configured to adjust a setting of said at least one valve based on a target profile of said carrier airflow.

### Claim 3 (depends on 2)

The inhaler device according to claim 2, wherein said controller is configured to adjust said at least one valve based on a difference between said target profile and the carrier airflow rate as indicated by said sensor.

### Claim 4 (depends on 2)

The inhaler device according to claim 2, wherein said target profile comprises a constant carrier airflow rate of between 0.5 L/min-2 L/min through said dose cartridge.

### Claim 5 (depends on 1)

The inhaler device according to claim 1, wherein said valve is positioned to indirectly affect said carrier airflow.

### Claim 6 (depends on 1)

The inhaler device according to claim 1, wherein said sensor is positioned within said first conduit.

### Claim 7 (depends on 6)

The device according to claim 6, wherein said sensor is positioned between a second opening of said first conduit through which ambient air enters, and said dose cartridge position.

### Claim 8 (depends on 1)

The inhaler device according to claim 1, further comprising a second conduit for conducting shunting airflow, said second conduit connected to said first conduit at a location that is in between said dose cartridge position and said opening through which the user inhales.

### Claim 9 (depends on 8)

The inhaler device according to claim 8, wherein said valve is positioned to control a rate of said shunting airflow to thereby affect carrier airflow.

### Claim 10 (depends on 9)

The inhaler device according to claim 9, wherein said controller is configured to adjust a setting of said valve.

### Claim 11 (depends on 9)

The inhaler device according to claim 9, wherein said valve is located at an opening of said second conduit where said second conduit connects to said first conduit.

### Claim 12 (depends on 1)

The inhaler device according to claim 1, wherein said controller is configured to dynamically modify said airflow rate according to at least one of: said sensor indication and a current setting of said valve.

### Claim 13 (depends on 1)

The inhaler device according to claim 1, wherein said controller is configured to provide an indication to the user to modify their inhalation effort based on said at least one parameter obtained by said sensor.

### Claim 14 (depends on 1)

The inhaler device according to claim 1, wherein said dose cartridge comprises an electrically resistive heating element configured to heat said drug dose so as to release said at least one drug substance by vaporization.

### Claim 15 (depends on 14)

The inhaler device according to claim 14, wherein said electrically resistive heating element is structured with openings suitable to allow said carrier airflow through.

### Claim 16 (depends on 14)

The inhaler device according to claim 14, wherein said sensor is positioned away from vapor condensation.

### Claim 17 (depends on 1)

The inhaler device according to claim 1, wherein said controller is configured to adjust a setting of said at least one valve according to a target temperature profile.

### Claim 18 (depends on 1)

The inhaler device according to claim 1, wherein said controller is configured to control said heater assembly according to a target temperature profile.

### Claim 19 (depends on 1)

The inhaler device according to claim 1, wherein said sensor is a differential pressure sensor.

### Claim 20 (depends on 1)

The inhaler device according to claim 1, wherein said dose cartridge comprises plant material.

### Claim 21 (depends on 20)

The inhaler device according to claim 20, wherein said plant material comprises cannabis and said at least one drug substance comprises Tetrahydrocannabinol (THC).

### Claim 22 (depends on 20)

The inhaler device according to claim 20, wherein said plant material comprises tobacco and said at least one drug substance comprises nicotine.

### Claim 23 (depends on 20)

The inhaler device according to claim 20, wherein said plant material is in the form of particles arranged to allow for air to flow through.

### Claim 24 (depends on 1)

The inhaler device according to claim 1, wherein said source material comprises a solid which is restrained within said dose cartridge.

### Claim 25 (depends on 1)

The inhaler device according to claim 1, wherein said heater assembly comprises at least one electrode configured to apply an electric current to an electrically resistive heating element of said dose cartridge.

### Claim 26 (depends on 1)

The inhaler device according to claim 1, wherein said first conduit extends beyond said dose cartridge position to said opening through which the user inhales of said inhaler device so that carrier airflow entering said inhaler device via a second opening of said first conduit flows from one side of said dose cartridge, through said source material, to an opposite side of said dose cartridge, continuing via said first conduit to said opening through which the user inhales.

### Claim 27 (depends on 1)

The inhaler device according to claim 1, wherein said first conduit is sized so that when a dose cartridge is held within said dose cartridge position by said holder, the dose cartridge blocks said first conduit to provide for directing said at least 90% of said carrier airflow through said source material.

### Claim 28 (depends on 1)

The inhaler device according to claim 1, wherein said heater assembly is incorporated within said dose cartridge.