FLOW REGULATING INHALER DEVICE

• US 20170203058A1
• Filed: 06/30/2015
• Published: 07/20/2017
• 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
• Granted Patent: US 9,993,602 B2
• Time in Patent Office: 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

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. An inhaler device for delivery to an inhaling user of at least one drug substance emitted from a dose cartridge, the inhaler device comprising:

a first conduit for conducting a carrier airflow to a proximal opening of a mouthpiece from which the user inhales;

a holder configured to position the dose cartridge at a dose cartridge position defined by the holder within the carrier airflow of the first conduit;

a second conduit, pneumatically coupled to the first conduit, for conducting a shunting airflow to the mouthpiece without passing the shunting airflow through the dose cartridge position;

at least one valve in at least one of the first and second conduits;

wherein the at least one valve is operated by a valve controller to control a rate of carrier airflow in response to a negative pressure generated by the inhaling user;

a third conduit configured to conduct bypass airflow to the mouthpiece through a path separated from the first and second conduits, wherein the bypass airflow through the third conduit is controlled by a bypass valve; and

a bypass valve controller functionally connected to operate the bypass valve to control airflow through the third conduit, wherein the valve controller and/or bypass valve controller are configured to substantially reduce a total rate of airflow to the user for an intermediate period after a first period of airflow, and then open at least the third conduit.

2. The inhaler device of claim 1, comprising at least one sensor positioned and configured for detecting at least one parameter indicating a rate of the carrier airflow.

3. The inhaler device of claim 2, wherein the at least one sensor comprises a pressure sensor positioned in the first conduit proximal to the dose cartridge position.

4. The inhaler device of claim 1, wherein the valve controller is functionally connected to receive an indication of the rate of the carrier airflow from the at least one sensor, and to operate the at least one valve based on the indication of the rate of the carrier airflow and a target profile for the carrier airflow.

5. The inhaler device of claim 4, wherein the indicating parameter comprises a rate of the carrier airflow sensed while the second conduit is at least partially obstructed.

6. The inhaler device of claim 5, wherein the valve controller is configured to operate the at least one valve based on a difference between the target profile and the rate of the carrier airflow sensed while the second conduit is at least partially obstructed.

7. The inhaler device of claim 1, wherein the controller is configured to modify the target profile based on the received indication of the rate of carrier airflow.

8. The inhaler device of claim 1, wherein the second conduit is connected to at least the first conduit at a junction between the dose cartridge position and the proximal opening of the mouthpiece, and the junction is configured to conduct airflow from the second conduit to circumferentially surround the carrier airflow.

9. The inhaler device of claim 1, wherein the valve controller is configured to substantially reduce a total rate of airflow to the user for an intermediate period after a first period of airflow.

10. The inhaler device of claim 9, wherein the substantial reduction in the rate of total airflow is to no more than 50% of the total rate of airflow during the first period of airflow.

12. The inhaler device of claim 1, wherein the third conduit comprises a plurality of tracts.

15. The inhaler device of claim 1, wherein the at least one valve and at least one bypass valve comprise a plurality of valve apertures arranged on a mounting movable at least from a first position to a second position, such that moving to the second position aligns a valve aperture to close of one of the conduits, while also aligning a valve aperture to at least partially open another of the conduits.

16. The inhaler device of claim 15, wherein the mounting comprises at least one rotating disc having at least one valve aperture passing therethrough, and the rotating disc is rotatable at least from the first position to the second position to change the alignment of the aperture to the conduit.

17. The inhaler device of claim 15, wherein the mounting comprises:

at least one inner tube having apertures into the conduits; and

at least one outer tube having a wall surrounding the inner tube and having the at least one valve aperture through the wall of the at least one outer tube;

wherein the at least one outer tube and the at least one inner tube are movable with respect to the other at least from the first position to the second position to change the alignment of the apertures to the conduits.

18. The inhaler device of claim 17, wherein the at least one outer tube comprises two separately movable outer tubes;

and

wherein moving one of the two separately movable outer tubes controls the degree of opening of one conduit, and moving the other controls the degree of opening of another conduit.

19. The inhaler device of claim 1, comprising a heating assembly configured to heat material of the drug dose cartridge comprising the at least one drug substance to vaporize the at least one drug substance from the material, wherein the released vapors flow into the first conduit and enter the carrier airflow.

20. The inhaler device of claim 19, wherein the heating assembly comprises an electrode configured to apply an electric current to an electrically resistive heating element of the dose cartridge, when the dose cartridge is positioned by the holder.

21. The inhaler device of claim 19, comprising:

at least one sensor positioned and configured for detecting at least one parameter indicating a rate of the carrier airflow; and

a heating controller functionally connected to control heating of the material of the drug dose cartridge, based on the at least one parameter indicating the rate of carrier airflow.

22. The inhaler device of claim 21, comprising a temperature sensor positioned to detect a temperature of the drug dose cartridge, wherein the heating controller is functionally connected to receive an indication of the temperature from the temperature sensor, and to operate the at least one valve based on the indication of the temperature.

23. The inhaler device of claim 22, wherein the valve controller operates the at least one valve to reduce the carrier airflow if the temperature falls below a threshold.

24. The inhaler device of claim 1, wherein the target profile comprises a constant flow rate through the first conduit and the dose cartridge position for at least a certain period.

25. The inhaler device of claim 1, wherein the heating controller is configured to activate drug substance release when commencement of inhalation by the user is detected or when the rate of carrier airflow is above a threshold.

26. The inhaler device of claim 1, wherein at least the valve controller is configured to communicate with one or more of a user interface and a physician interface.

27. The inhaler device of claim 1, wherein the at least one valve is operable by the valve controller based on one or more of:

a flow rate of inhalation, a flow rate through the dose cartridge position, and a defined time from a detected or estimated event.

28. The inhaler device of claim 1, comprising a fan positioned to affect carrier airflow through the first conduit.

29. The inhaler device of claim 28, wherein a fan controller is functionally connected to operate the fan to induce airflow based on the indication of the rate of carrier airflow from the sensor and a target profile for the carrier airflow.

30. The inhaler device of claim 1, wherein the at least one valve comprises a valve positioned along the second conduit configured to at least partially close to limit a rate of shunting airflow, and thereby to affect the rate of carrier airflow.

31. The inhaler device of claim 1, wherein the valve controller comprises a portion of the at least one valve mechanically configured to adjust a degree of opening of the at least one valve based on at least one of the shunting airflow and the carrier airflow.

32. The inhaler device of claim 1, wherein the holder positions the dose cartridge such that at least 90% of the carrier airflow through the first conduit passes through the dose cartridge.

47. The inhaler device of claim 1, comprising a plurality of holders.

48. The inhaler device of claim 20, wherein the holder positions the dose cartridge within the first conduit such that such that the electrode of the heating assembly is sealed from the carrier airflow.

11. (canceled)

13-14. -14. (canceled)

33-46. -46. (canceled)

49-50. -50. (canceled)