Method and device for vaporization and inhalation of isolated substances

• US 10,080,851 B2
• Filed: 12/19/2016
• Issued: 09/25/2018
• Est. Priority Date: 06/30/2014
• Status: Active Grant

• Current Assignee: Syqe Medical Ltd.
• Original Assignee: Syqe Medical Ltd.
• Inventors: Davidson, Perry, Schorr, Aaron, Kroll, Asaf, Schwartz, Binyamin
• Primary Examiner(s): TSAI, MICHAEL JASPER
• Application Number:
  US15/382,819
• Publication Number:
  US 20170136196A1
• Time in Patent Office: 645 Days
• CPC Class Codes: A24F 40/42 Cartridges or containers for inhalable precursors
• 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 16/14 : 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 2205/0216 : Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/273 : preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 2205/276 : preventing unwanted use
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• 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 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• 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 2205/502 : 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: 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
• CPC Class Codes: H05B 2203/016 : Heaters using particular connecting means
• CPC Class Codes: H05B 2203/021 : Heaters specially adapted for heating liquids
• CPC Class Codes: H05B 2203/022 : Heaters specially adapted for heating gaseous material
• CPC Class Codes: H05B 3/04 : Waterproof or air-tight seals for heaters
• CPC Class Codes: H05B 3/265 : the insulating base being an inorganic material, e.g. ceramic H05B3/262 takes precedence

Abstract

A dose unit including at least one isolated bioactive agent applied on a carrier material in thermal contact with an electrically heating element configured to vaporize a pre-determined amount of the agent for pulmonary delivery thereof is provided herein, as well as devices for effecting vaporization and pulmonary delivery of the isolated agent, and methods for preparing the dose unit, controllably releasing the agent therefrom, methods for pulmonary delivery thereof and methods of treatment of medical conditions treatable by pulmonary delivery of the isolated bioactive agent.

Claims

1. A method of delivering to a user an active agent from a dose unit comprised in a dose unit dispenser having a plurality of individual dose units, comprising:

dispensing an individual dose unit from said dose unit dispenser into a use position of an inhaler, said dose unit having an individually embedded electrically resistive heating element shaped and sized to retain a solid, air-permeable pallet having a low electric conductance so as to avoid current passing therethrough instead of through said electrically resistive heating element, from which said active agent is vaporized;

said dispensing comprising engaging a geometry of said individual dose unit to transport it to said use position;

applying a current to said electrically resistive heating element of said dose unit,

thereby heating said dose unit and causing at least a portion of said active agent to vaporize; and

directing airflow through said dose unit out to an output aperture, thereby delivering said vaporized active agent from said dose unit to said user.

2. The method of claim 1, comprising delivering a single dose of said vaporized active agent from said dose unit to said user in a single vaporization event, followed by moving said individual dose unit from said use position.

3. The method of claim 2, comprising delivering said single dose in a single inhalation session.

4. The method of claim 1, comprising delivering said vaporized active agent from said dose unit to said user in a plurality of vaporization events, prior to moving said individual dose unit from said use position.

5. The method of claim 1, comprising controlling said heating to reproducibly deliver a pre-determined amount of said active agent.

6. The method of claim 1, comprising controlling said passing airflow to reproducibly deliver a pre-determined amount of said active agent.

7. The method of claim 1, comprising clamping said individual dose unit prior to said applying.

8. The method of claim 7, wherein said clamping comprises positioning electrodes for contacting said embedded electrically resistive heating element.

9. The method of claim 8, wherein said contacting comprises press contact.

10. The method of claim 7, wherein said clamping comprises sealing an airway passage around at least a portion of said individual dose unit.

11. The method of claim 10, comprising opening said clamping to receive said individual dose unit and closing said clamping to seal an airway passage around at least a portion of said individual dose unit.

12. The method of claim 1, comprising passing current through a pathway extending over all of at least one side of said individual dose unit.

13. The method of claim 1, comprising passing current through a pathway extending over all of two sides of said individual dose unit.

14. The method of claim 13, wherein said passing current comprises evenly distributing heat over a surface of said individual dose unit.

15. The method of claim 1, wherein said dispensing comprises locking said individual dose unit by at least one locking member.

16. The method of claim 15, wherein said dispensing comprises moving said individual dose unit while being locked with said at least one locking member.

17. The method of claim 1, comprising dispensing a new individual dose unit into said use position.

18. The method of claim 1, comprising ejecting said individual dose unit from the use position after said delivering of the vaporized active agent from said dose unit to the user.

19. The method of claim 18, wherein said ejecting comprises moving said individual dose unit out of said use position and into said dose unit dispenser.

20. The method of claim 18, wherein said ejecting comprises disengaging said individual dose unit from a locking member.

21. The method of claim 1, wherein said dispensing comprises engaging and pulling on latch mandibles of said dose unit.

22. The method of claim 1, wherein said dispensing comprises engaging said dose unit using a transport arm of a dose puller.

23. The method of claim 1, comprising controlling the applying of a current and the directing of airflow to reproducibly deliver a predetermined amount of said vaporized active agent.

24. The method of claim 1, wherein when said dose unit is in said use position dispensing of a new dose unit is prevented until said dose unit is returned to said dispenser.

25. The method of claim 1, wherein when said dose unit is in said use position dispensing of a new dose unit is prevented until said dose unit is removed from said use position.

26. The method of claim 1, wherein said pallet comprises a carrier material;

said carrier material is formed from substances selected from the group consisting of glass, quartz, ceramic composite, silicon carbide, mullite, alumina, carbon species, silicone and polytetrafluoroethylene.

27. The method of claim 1, wherein said pallet comprises a carrier material, said carrier material is formed from substances consisting of plant material.

28. A method of delivering to a user an active agent from a dose unit comprised in a dose unit dispenser having a plurality of individual dose units, comprising:

dispensing an individual dose unit from said dose unit dispenser into a use position of an inhaler, said dose unit having an individually embedded electrically resistive heating element shaped as two layers and sized to retain therebetween a solid, air-permeable pallet from which said active agent is vaporized;

said dispensing comprising engaging a geometry of said individual dose unit to transport it to said use position;

applying current to said electrically resistive heating element of said dose unit,

thereby heating said dose unit and causing at least a portion of said active agent to vaporize; and

directing airflow through said dose unit out to an output aperture, thereby delivering said vaporized active agent from said dose unit to said user.