Flow regulating inhaler device

• US 10,166,349 B2
• Filed: 12/28/2016
• Issued: 01/01/2019
• 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): Anderson, Gregory
• Assistant Examiner(s): Luarca, Margaret
• Application Number:
  US15/391,896
• Publication Number:
  US 20170106153A1
• Time in Patent Office: 734 Days
• Field of Search: 12820314, 131286, 131243, 131244
• 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

Some embodiments of the invention relate to an inhaler device for pulmonary delivery of at least one substance from a drug dose cartridge to an inhaling user, comprising: 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. A method of flushing drug residues from a conduit of an inhaler device, the device comprising at least a first conduit for conducting a carrier airflow which delivers at least one drug substance to a user, the method comprising:

allowing air to be drawn into said first conduit during inhalation;

during a first time period within said inhalation, heating a drug dose to release said drug substance into said carrier airflow for delivering to said user, while regulating a rate of said carrier airflow according to a target profile;

during a second time period within said inhalation, after heating has terminated, allowing increased carrier airflow through said first conduit to flush drug residues from said first conduit;

wherein said drug residues are flushed via said first conduit into a mouth of said user.

2. The method according to claim 1, wherein said allowing increased airflow through said first conduit comprises directing increased airflow through said drug dose.

3. The method according to claim 1, wherein said inhaler device further comprises at least a second conduit for conducting a shunting airflow, and wherein said allowing increased airflow through said first conduit is achieved by restricting said shunting airflow.

4. The method according to claim 3, wherein said restricting comprises fully obstructing said shunting airflow.

5. The method according to claim 3, wherein during a third time period of said inhalation airflow is allowed through said first conduit and said second conduit.

6. The method according to claim 1, wherein said first time period is 15-30 times longer than said second time period.

7. The method according to claim 1, wherein said second time period is about 100 msec long.

8. The method according to claim 1, wherein said target profile comprises maintaining said carrier airflow at a constant rate during said first time period.

9. The method according to claim 8, wherein said constant rate is selected from the range of 0.5 L/min to 2 L/min.

10. The method according to claim 1, wherein said drug dose comprises a botanical substance.

11. The method according to claim 10, wherein said botanical substance comprises cannabis and said at least one drug substance comprises THC.

12. The method according to claim 10, wherein said botanical substance comprises tobacco and said at least one drug substance comprises nicotine.

13. The method according to claim 1, wherein said heating is initiated in response to detection of commencement of inhalation.

14. The method according to claim 13, wherein detecting of said commencement of inhalation comprises measuring, via one or more sensors, an indication that flow rate is above a predefined threshold.

15. The method according to claim 1, wherein said allowing increased carrier airflow through said first conduit is started only when said heating has terminated.

16. The method according to claim 2, wherein said increased carrier airflow flushes drug residues from said first conduit and from said drug dose to deliver said drug residues to said user.

17. An inhaler device for delivering at least one drug substance to a user, the device comprising:

a drug dose from which at least one drug substance is released by heating;

a first conduit which carries a carrier airflow including sad at least one drug substance; and

a controller programmed with a schedule according to which heating is actuated to heat said drug dose, and, following termination of said heating, to allow increased carrier airflow through said first conduit to flush drug residues from said first conduit into a mouth of said user.

18. The device according to claim 17, comprising a second conduit for conducting a shunting airflow which bypasses said drug dose and then joins said carrier airflow.

19. The device according to claim 17, wherein said dose unit is contained within a cartridge and wherein said first conduit extends through said cartridge such that airflow passes via said drug dose.

20. The device according to claim 18, wherein said first conduit joins said second conduit at a location that is in between a mouthpiece of said device and said drug dose.

21. The device according to claim 17, wherein said controller is configured to set at least one of a temperature profile of said heating element and a duration of heating according to a current rate of said carrier airflow.

22. The device according to claim 17, further comprising a sensor configured to indicate a rate of said carrier airflow.

23. The device according to claim 17, further comprising a sensor configured to indicate a temperature of said drug dose.

24. The device according to claim 23, wherein said controller is configured to maintain said dose unit at a target temperature for a period of time.

25. The device according to claim 17, wherein said schedule is set according to a stored profile of release of said drug substance.

26. A method of flushing drug residues from a conduit of an inhaler device, the device comprising at least a first conduit for conducting a carrier airflow which delivers at least one drug substance to a user, the method comprising:

allowing air to be drawn into said first conduit during inhalation;

during a first time period within said inhalation, heating a drug dose to release said drug substance into said carrier airflow for delivering to said user, while regulating a rate of said carrier airflow according to a target profile;

during a second time period within said inhalation, after heating has terminated, allowing increased carrier airflow through said first conduit to flush drug residues from said first conduit;

wherein said allowing increased airflow through said first conduit comprises directing increased airflow through said drug dose.

27. The method according to claim 26, wherein said inhaler device further comprises at least a second conduit for conducting a shunting airflow, and wherein said allowing increased airflow through said first conduit is achieved by restricting said shunting airflow.

28. The method according to claim 27, wherein said restricting comprises fully obstructing said shunting airflow.

29. The method according to claim 27, wherein during a third time period of said inhalation airflow is allowed through said first conduit and said second conduit.

30. The method according to claim 26, wherein said first time period is 15-30 times longer than said second time period.

31. The method according to claim 26, wherein said second time period is about 100 msec long.

32. The method according to claim 26, wherein said target profile comprises maintaining said carrier airflow at a constant rate during said first time period.

33. The method according to claim 32, wherein said constant rate is selected from the range of 0.5 L/min to 2 L/min.

34. The method according to claim 26, wherein said drug dose comprises a botanical substance.

35. The method according to claim 34, wherein said botanical substance comprises cannabis and said at least one drug substance comprises THC.

36. The method according to claim 34, wherein said botanical substance comprises tobacco and said at least one drug substance comprises nicotine.

37. The method according to claim 26, wherein said heating is initiated in response to detection of commencement of inhalation.

38. The method according to claim 37, wherein detecting of said commencement of inhalation comprises measuring, via one or more sensors, an indication that flow rate is above a predefined threshold.

39. The method according to claim 26, wherein said allowing increased carrier airflow through said first conduit is started only when said heating has terminated.

40. The method according to claim 26, wherein said increased carrier airflow flushes drug residues from said first conduit and from said drug dose to deliver said drug residues to said user.