Flow regulating inhaler device

• US 10,369,304 B2
• Filed: 11/29/2016
• Issued: 08/06/2019
• Est. Priority Date: 06/30/2014
• Status: Active Grant

• Current Assignee: Syqe Medical Ltd.
• Original Assignee: Syqe Medical Ltd.
• Inventors: Davidson, Perry, Schorr, Aaron, Schwartz, Binyamin
• Primary Examiner(s): Woodward, Valerie L
• Application Number:
  US15/362,883
• Publication Number:
  US 20170119981A1
• Time in Patent Office: 980 Days
• CPC Class Codes: A61B 2560/028 Arrangements to prevent overuse, e.g. by counting the number of uses
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61K 31/05 Phenols cannabinoids A61K31/658
• CPC Class Codes: A61K 31/352 condensed with carbocyclic rings, e.g. methantheline cannabinoids A61K31/658
• CPC Class Codes: A61K 31/465 Nicotine; Derivatives thereof
• CPC Class Codes: A61K 36/185 Magnoliopsida (dicotyledons)
• CPC Class Codes: A61K 36/81 Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
• CPC Class Codes: A61K 9/007 Pulmonary tract; Aromatherapy
• CPC Class Codes: 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
• CPC Class Codes: 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
• CPC Class Codes: A61M 11/041 using heaters
• CPC Class Codes: A61M 11/042 electrical
• CPC Class Codes: A61M 15/0001 Details of inhalators; Constructional features thereof
• CPC Class Codes: A61M 15/0003 with means for dispensing more than one drug
• CPC Class Codes: A61M 15/0013 with inhalation check valves
• CPC Class Codes: A61M 15/0015 located upstream of the dispenser, i.e. not traversed by the product
• CPC Class Codes: A61M 15/002 with air flow regulating means
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0028 : using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 15/0045 : using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/005 : the dosages being arranged on a cylindrical surface
• CPC Class Codes: A61M 15/0051 : the dosages being arranged on a tape, e.g. strips
• CPC Class Codes: A61M 15/0065 : Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/0066 : with means for varying the dose size
• CPC Class Codes: A61M 15/0091 : mechanically breath-triggered
• CPC Class Codes: A61M 15/06 : Inhaling appliances shaped like cigars, cigarettes or pipes
• CPC Class Codes: A61M 16/0009 : with sub-atmospheric pressure, e.g. during expiration
• CPC Class Codes: A61M 16/0066 : Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/024 : including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/14 : by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: A61M 16/20 : Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/201 : Controlled valves
• CPC Class Codes: A61M 16/204 : used for inhalation control
• CPC Class Codes: A61M 16/208 : Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2016/0021 : with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 : pressure meter
• CPC Class Codes: A61M 2016/0039 : in the inspiratory circuit
• CPC Class Codes: A61M 2202/04 : Liquids
• CPC Class Codes: A61M 2202/064 : Powder
• CPC Class Codes: A61M 2205/0216 : Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/07 : having air pumping means
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3313 : used specific wavelengths
• CPC Class Codes: A61M 2205/3317 : Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 : Temperature
• 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 2205/36 : related to heating or cooling
• CPC Class Codes: A61M 2205/43 : making noise when used correctly
• CPC Class Codes: A61M 2205/44 : making noise when used incorrectly
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 : by audible feedback
• CPC Class Codes: A61M 2205/582 : by tactile feedback
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 2205/7545 : for solid matter, e.g. microaggregates
• CPC Class Codes: A61M 2206/11 : Laminar flow
• CPC Class Codes: A61M 2206/18 : Coaxial flows, e.g. one flow within another
• CPC Class Codes: A61M 2230/40 : Respiratory characteristics
• CPC Class Codes: A61P 1/00 : Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 : for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/08 : for nausea, cinetosis or vertigo; Antiemetics
• CPC Class Codes: A61P 1/14 : Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
• CPC Class Codes: A61P 11/00 : Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 : Antiasthmatics
• CPC Class Codes: A61P 13/10 : of the bladder
• CPC Class Codes: A61P 15/00 : Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 17/02 : for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 17/04 : Antipruritics
• CPC Class Codes: A61P 19/02 : for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 21/00 : Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/04 : Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/08 : Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 25/14 : for treating abnormal movements, e.g. chorea, dyskinesia
• CPC Class Codes: A61P 25/16 : Anti-Parkinson drugs
• CPC Class Codes: A61P 25/18 : Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/20 : Hypnotics; Sedatives
• CPC Class Codes: A61P 25/22 : Anxiolytics
• CPC Class Codes: A61P 25/24 : Antidepressants
• CPC Class Codes: A61P 25/30 : for treating abuse or dependence
• CPC Class Codes: A61P 25/32 : Alcohol-abuse
• CPC Class Codes: A61P 27/06 : Antiglaucoma agents or miotics
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 31/14 : for RNA viruses
• CPC Class Codes: A61P 31/18 : for HIV
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 35/02 : specific for leukemia
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 : Antihypertensives
• CPC Class Codes: H05B 1/025 : For medical applications

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

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.

2. 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.

3. 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.

4. 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.

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

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

7. 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.

8. 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.

9. 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.

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

11. 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.

12. 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.

13. 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.

14. 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.

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

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

17. 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.

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

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

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

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

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

23. 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.

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

25. 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.

26. 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.

27. 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.

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