JP2008509721A - Inhalation shock ignition system - Google Patents

Abstract

An inhalation actuated impact ignition system is disclosed. The system is configured to actuate the impact igniter with a housing defining an air path, an air flow sensing actuator coupled to the air path, and an air flow in the air path generated by the patient inhaling through the mouthpiece. And a mechanism coupled to the air flow sensing actuator.
[Selection] Figure 1

Description

Field of Invention

  [001] The present invention relates to an impact ignition system operable by inhalation, an impact actuated heating element, and operating the heating element using an inhalation actuated impact ignition system.

Background of the Invention

  [002] Pulmonary delivery is known as an effective method of administering physiologically active compounds to patients for the treatment of diseases and disorders. Devices developed for pulmonary delivery produce aerosols of physiologically active compounds that are inhaled by the patient, which are used to treat symptoms in the patient's respiratory tract and / or enter the patient's systemic circulation Is done. Devices that generate aerosols of physiologically active compounds include nebulizers, pressurized metered dose inhalers, and dry powder inhalers. Nebulizers are based on atomization of solution solutions, while pressurized metered dose inhalers and dry powder inhalers are based on floating and dispersion of dry powder in an air stream.

  [003] Aerosols for inhalation of physiologically active compounds can also be generated by vaporizing the substance to form a condensed aerosol containing the active compound in the air stream. Condensed aerosols are generated when gas phase materials concentrate or react to form particulates. An example of a device and method for generating a condensate aerosol using a vaporization method is described in US patent application Ser. No. 10 / 861,554, filed Jun. 3, 2004, entitled “Multiple Dose Condensation Aerosol Devices and Methods of Forming”. "Condensation Aerosols (Multi-Dose Condensation Aerosol Devices and Methods for Forming Condensation Aerosols)" and the title "Self-Contained Heating Unit and Drug" of US Patent No. 10 / 850,895 filed May 20, 2004. -Supply Unit Employing Same (internal heating unit and drug supply unit using this heating unit) " The entire contents of these patent applications are hereby incorporated by reference.

  [004] Efficient production of a condensing aerosol containing the drug is facilitated by minimizing drug degradation by rapidly vaporizing the drug. The vaporized drug can condense to produce an aerosol characterized by high yield and purity. For use in medical devices, it is useful that the heat source for vaporizing the drug is small and capable of generating fast thermal impulses. A chemical-based heating unit may include fuel that undergoes an exothermic metal redox reaction within an enclosure, such as those described in US patent application Ser. No. 10 / 850,895 filed on May 20, 2004. The title of the invention is “Self-Contained Heating Unit and Drug-Supply Unit Employing Same”, the entire content of which is hereby incorporated by reference. Be incorporated.

  [005] Ignite the fuel to generate a self-supporting redox reaction. When a portion of the fuel is ignited, the heat generated by the redox reaction can ignite nearby unburned fuel until all of the fuel is consumed in the chemical reaction process. The exothermic redox reaction can be initiated by supplying energy to at least a portion of the fuel. The energy absorbed by the fuel or by the elements in contact with the solid fuel is converted into heat. When the fuel is heated to a temperature above the autoignition temperature of the agent (eg, the minimum temperature required to initiate or generate self-sustaining combustion when no combustion source or flame is present), the redox reaction causes the fuel to react. Start solid fuel ignition in a self-supporting reaction until consumed.

  [006] As disclosed in the title of the invention of US Patent No. 10 / 850,895 “Self-Contained Heating Unit and Drug-Supply Unit Employing Same” The self-ignition temperature of the solid fuel containing the metal reducing agent and the metal-containing oxidizing agent is in the range of 400 ° C to 500 ° C. Such a high self-ignition temperature facilitates safe handling and safe use of fuel in many use situations (eg, portable medical devices) and for the same reason to achieve such high temperatures It is necessary to start a self-supporting reaction by supplying a large amount of energy to the fuel.

  [007] As is known in the art, for example, in the fireworks industry, sparks can be utilized to ignite fuel compositions safely and efficiently. Sparks refer to the breakdown of dielectric media or the release of burning particles. In the first meaning, the dielectric breakdown occurs, for example, between electrodes that are spaced from each other at which a voltage is applied. Sparks are also generated by ionization of compounds in a strong electromagnetic field. Examples of burning particles include those generated by friction and destructive sparks generated by intermittent current. A self-sustaining oxidation-reduction reaction can be initiated by projecting a spark of sufficient energy onto the fuel

  [008] A small initiator composition and igniter for igniting a spark generating composition capable of igniting metal oxidation / reduction fuel using electrical resistance heating produces a small amount of gas suitable for closed systems, medical, food And other such explosives classified by the U.S. Department of Transportation for use in such devices, such as, for example, the title "Stable Initiator Compositions and Igniters (Stable Initiators) of U.S. Patent Application No. 10 / 851,018. The entire contents of this US patent application are incorporated herein by reference. Batteries are used to provide power to electrical resistance heaters used in such devices. Batteries are expensive and bulky and can cause disposal problems.

  [009] The impact mechanism can also be used to ignite the initiator composition. For example, impact ignition systems are used in the photographic industry, for example, as disclosed in US Pat. No. 3,724,991. The flash bulb includes a sealed light transmissive envelope that includes a combustion-generating gas, such as oxygen, along with a photogenerating combustible, such as zirconium, aluminum, or hafnium. In a shock ignition flash bulb, a load of shock sensitive initiator material is placed in an easily deformable metal ignition tube and sealed in a length of glass tube that forms an envelope containing fuel. Stick out from one end. The initiator composition is coated on a wire anvil supported in the ignition tube or deposited in a deformable tube. The initiator composition is ignited by a mechanical impact on the tube that is sufficient to deform the tube. Abrupt combustion of the initiator composition occurs due to the compressive force on the initiator composition. Sparks generated by the burning initiator composition are propelled through the tube to ignite the fuel in the envelope.

  [010] In years of use in the photographic industry, impact ignition systems have been shown to be compact, safe, reliable and suitable for mass production. An impact ignition system for use in a portable medical device, in particular an aerosol inhalation medical device, is disclosed in US patent application Ser. No. 10 / 885,883, filed May 20, 2004, entitled “Percussively Ignited or Electrically Selfed Self. -Contained Heating Unit and Drug Supply Unit Employing Same (Impact-Ignition or Electric-Ignition Built-in Heating Unit and Drug Supply Unit Using This Unit) ", the entire contents of which are hereby incorporated by reference. Be incorporated. However, no such system has been disclosed so far that utilizes suction actuation to mechanically impact igniters and / or igniter anvils and fuel contents within a single enclosure. With the advent of portable medical devices that can produce high-purity drug aerosols by rapidly vaporizing the drug film, where the metal / redox reaction provides a hot thermal impulse, there is a need for an impact ignition system that can operate by inhalation. Exists.

Summary of the Invention

  [011] Certain embodiments of the present invention provide an inhalation actuated impact ignition system. The system includes a housing defining an air passage (the housing comprises a mouthpiece having at least one air inlet and at least one air outlet), an air flow sensing actuator coupled to the air passage; And a mechanism coupled to an air flow sensing actuator configured to operate the impact igniter, the impact igniter being operated by the air flow in the air path generated by inhalation through the mouthpiece.

  [012] A second aspect of the invention provides a method of operating an impact igniter. The method includes providing an inhalation-actuated impact ignition system that generates airflow in an air passage by inhaling through a mouthpiece and actuates an airflow sensing actuator.

  [013] A third aspect of the invention provides a heating element that is shock activated by inhalation. The heating element includes an enclosure having a region that is deformed by mechanical shock, an anvil disposed within the enclosure, an impact initiator composition disposed within the enclosure (the initiator composition is deformable in the enclosure). And a fuel disposed in an enclosure configured to be ignited by the initiator composition.

  [014] A fourth aspect of the present invention provides an inhalation activated heating heat system. The system includes a housing defining an air passage (the housing comprises a mouthpiece having at least one air inlet and at least one air outlet), an air flow sensing actuator coupled to the air passage; A mechanism coupled to an air flow sensing actuator configured to actuate the impact igniter and a heating element including fuel, wherein the fuel is configured to be ignited by the impact igniter, the impact igniter passing through the mouthpiece Actuated by the air flow in the air path generated by inhalation.

  [015] A fifth aspect of the invention provides a method of operating an impact-actuated heat package. The method includes inhaling to generate an air flow, activating an air flow sensing actuator coupled to the air flow, activating an impact igniter coupled to the air flow sensing actuator, and fuel. Igniting and generating heat.

  [016] A sixth aspect of the invention provides a method for producing a condensed aerosol of a substance using an inhalation-actuated impact-acting heating element.

  [017] Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive to certain embodiments, as defined in the claims. That should be understood.

Description of various embodiments

  [024] Reference will now be made in detail to embodiments of the invention. While specific embodiments of the invention are disclosed, it is understood that they are not intended to limit the embodiments of the invention to those described embodiments. On the contrary, references to embodiments of the invention are intended to include within the spirit and scope of the embodiments of the invention, as defined in the appended claims, as well as alternatives, modifications and equivalents. To do.

  [025] Unless otherwise specified, all numbers representing quantities and conditions used in the specification and claims are to be understood as being corrected in all cases by the term "about". is there.

  [026] In this application, the use of the singular includes the plural unless specifically stated otherwise. In this application, the use of “or” means “and / or” unless stated otherwise. Further, the use of the terms “including” and other conjugations such as “include” and “included” is not limiting. Also, terms such as “element” or “component” encompass both elements and components comprising one unit and elements and components comprising two or more subunits unless otherwise specified.

  [027] The impact igniter comprises a deformable portion, an anvil disposed adjacent to the deformable portion, and an initiator composition disposed between the anvil and the deformable portion. In some embodiments, an anvil in the impact igniter is not required. The initiator composition is actuated by a mechanical shock or force sufficient to compress the initiator composition between the deformable portion and the anvil. An example of an impact igniter is shown in FIG. FIG. 1 illustrates an impact igniter 10 with an anvil 12 disposed coaxially within a deformable enclosure 14. The outer part of the anvil 12 is coated with an internal compound. The anvil 12 is held in place by a recess 18 that maintains the initiator composition 16 in close proximity to but not in contact with the inner surface of the enclosure 14. In a region adjacent to the initiator composition 16, identified as region 20, due to sufficient mechanical impact or force applied to the outer wall of the enclosure 14, the region 20 is deformed, causing the initiator composition 16 to move to the anvil 12. Press. This compressive force ignites the initiator composition 16 and burns rapidly, releasing a spark. Next, fuel (not shown) can be ignited using sparks. In certain embodiments, the initiator composition is coated directly or placed inside a deformable enclosure as opposed to using a coated anvil.

  [028] In certain embodiments, the enclosure 14 can comprise a metal tube that can be deformed with an impact force in the range of about 0.5 in-lb to about 3.0 in-lb. As will be apparent to those skilled in the art, the magnitude of the applied impact force is limited by the strength of the tube and holder and can be readily determined. The thickness and material from which the tube is formed is such that the tube will reliably deform upon impact within a specific range of forces, but will not deform under normal use conditions. In certain embodiments, the tube is formed from a metal such as aluminum, nickel-chromium iron alloy, brass or steel and has a wall thickness ranging from about 0.001 inch to about 0.005 inch. In certain embodiments, upon impact, the tube can also maintain structural integrity so that it does not pierce or crack when the wall is deformed. In a particular embodiment, the enclosure comprises a stainless steel tube having a thickness of 0.005 inch ± 0.001 inch and a diameter of about 0.58 inch, the tube being subjected to an impact with a force of at least 0.75 in-lb. It can be deformed. For particular applications, other materials, dimensions and shapes may be used and / or optimized for the enclosure.

  [029] In certain embodiments, the anvil 12 comprises an incompressible rod, pin or wire. Anvil 12 is a solid material that provides a surface on which initiator composition 16 is compressed when the deformable portion is impacted. Examples of the material forming the anvil 12 include metals, alloys, ceramics, plastics, and composite materials. The diameter of the anvil 12 is slightly smaller than the inner diameter of the deformable tube 14. For example, the anvil 12 has a diameter of about 0.01 inches that is smaller than the inner diameter of the tube. At least a portion of the anvil 12 is coated with the impact initiator composition 16. The coating thickness of initiator composition 16 ranges from about 0.001 inch to about 0.05 inch. The thickness of the coating may be any suitable thickness that provides a spark for the intended application. Anvil 12 is disposed within tube 14 such that the surface of the outer surface of initiator composition 16 is separated from the inner wall of tube 14 by a few thousandths of an inch, for example about 0.004 inches. Anvil 12 is positioned within tube 14 to provide a thousandths of an inch gap between initiator composition 16 and the inner wall of tube 14. In certain embodiments, the anvil 12 is coaxially disposed within the tube 14. The anvil dimensions relative to other thicknesses of the initiator composition and the inner dimensions of the enclosure can be determined and / or optimized depending on the particular application and use conditions.

  [030] The anvil 12 is placed in a deformable enclosure 14 and held such that a gap is maintained between the coating of the initiator composition 16 and the inner wall of the enclosure. The position of the anvil 12 is held by, for example, a crimp, a recess, a protrusion, a gasket, an insert, or the like. The device for aligning the anvil 12 is separated or integrated into the anvil 12. In FIG. 1, a recess 18 holds the anvil 12 coaxially within the enclosure 14. In certain embodiments, it is desirable for any anvil alignment element to be non-flammable and maintain integrity at high temperatures, and in certain embodiments, to be thermally non-conductive. The crimp, recess or protrusion used to maintain the position of the anvil 12 protrudes around the anvil 12, or one or more spaces or voids are provided between the anvil 12 and the enclosure 14. May be separated. The space or void provides a substantially unobstructed area where the sparks generated by the rapid combustion of the initiator composition 16 can proceed. The anvil alignment feature contacts the anvil 12 in an area that is not coated with the initiator composition 16 of the anvil 12.

  [031] Impact actuation initiator compositions are known in the art. Initiator compositions used in impact ignition systems burn abruptly upon impact and generate strong sparks that can easily and reliably ignite fuels such as metal redox fuels. For use in closed systems, such as heat packages, it is useful that the initiator composition does not ignite explosively and does not produce excessive amounts of gas. A specific initiator composition is disclosed in US patent application Ser. No. 10 / 851,018, entitled “Stable Initiator Compositions and Igniters”, which is incorporated herein by reference in its entirety. The contents are incorporated herein by reference. The initiator composition comprises at least one metal reducing agent, at least one oxidizing agent and optionally at least one inactive binder.

  [032] In certain embodiments, the metal reducing agent is molybdenum, magnesium, phosphorus, calcium, strontium, barium, boron, titanium, zirconium, vanadium, niobium, tantalum, chromium, tungsten, manganese, iron, cobalt, nickel, Can include, but is not limited to copper, zinc, cadmium, tin, antimony, bismuth, aluminum and silicon. In certain embodiments, the metal reducing agent can include aluminum, zirconium and titanium. In certain embodiments, the metal reducing agent can include a plurality of metal reducing agents.

[033] In certain embodiments, the oxidant can include oxygen, an oxygen-based gas, and / or a solid oxidant. In certain embodiments, the oxidant includes a metal-containing oxidant. Examples of metal-containing oxidants include, but are not limited to perchlorates and transition metal oxides. Perchlorate salts include, but are not limited to, potassium perchlorate (KClO ₄ ), potassium chlorate (KClO ₃ ), lithium perchlorate (LiClO ₄ ), sodium perchlorate (NaClO ₄ ) and perchloric acid. Alkali metal or alkaline earth metal perchlorates such as magnesium (Mg (ClO ₄ ) ₂ ) can be included. In certain embodiments, the transition metal oxide acting as a metal-containing oxidant is an oxide of molybdenum such as MoO ₃ , an oxide of iron such as Fe ₂ O _3, or an oxide of vanadium such as V ₂ O ₅ . Chromium oxide such as CrO ₃ and Cr ₂ O ₃ , manganese oxide such as MnO ₂ , cobalt oxide such as Co ₃ O ₄ , silver oxide such as Ag ₂ O, and copper oxide such as CuO Oxides, tungsten oxides such as WO ₃ , magnesium oxides such as MgO, and niobium oxides such as Nb ₂ O _5, but are not limited thereto. In certain embodiments, the metal-containing oxidant can include a plurality of metal-containing oxidants.

  [034] In certain embodiments, the metal reducing agent and the metal-containing oxidant may be in the form of a powder. The term “powder” refers to powders, particles, globules, flakes, and any other particulate that exhibits an appropriate size and / or surface area to undergo self-propagating ignition. For example, in certain embodiments, the powder can include particles that exhibit an average diameter in the range of 0.001 μm to 200 μm.

  [035] In certain embodiments, the amount of oxidant in the initiator composition is related to the molar amount of oxidant at or near the eutectic point of the fuel compound. In certain embodiments, the oxidant is the major component, and in other embodiments, the metal reducing agent is the major component. Also, as is known in the art, the burning rate can be determined by changing the particle size of the metal and the metal-containing oxidant, and a smaller particle size is selected for fast burning (eg PCT International Publication). (See publication 2004/01396). Thus, in some embodiments, particles having a nanometer scale diameter are used when high speed combustion is desired.

  [036] In certain embodiments, the amount of metal reducing agent can range from 25% to 75% by weight of the total dry weight of the initiator composition. In certain embodiments, the amount of metal-containing oxidant ranges from 25% to 75% by weight of the total dry weight of the initiator composition.

  [037] In certain embodiments, the initiator composition comprises at least one metal, such as, for example, an alkali metal or alkaline earth metal chlorate or perchloric acid, as described herein. And at least one metal-containing oxidant, such as a salt or metal oxide and others described herein.

  [038] In certain embodiments, the initiator composition can include at least one metal reducing agent selected from aluminum, zirconium and boron. In certain embodiments, the initiator composition can include at least one oxidizing agent selected from molybdenum trioxide, copper oxide, tungsten trioxide, potassium chlorate, and potassium perchlorate.

  [039] In certain embodiments, aluminum can be used as a metal reducing agent. Aluminum can be obtained in a variety of sizes, such as nanoparticles, forming a protective oxide layer and thus commercially available in the dry state.

  [040] In certain embodiments, the initiator composition can include a plurality of metal reducing agents. In such compositions, at least one of the reducing agents may be boron. Examples of initiator compositions containing boron are disclosed in US Pat. Nos. 4,484,960 and 5,672,843. Boron can increase the rate at which ignition occurs and, as a result, can increase the amount of heat generated by the initiator composition.

  [041] In certain embodiments, reliable and reproducible controlled fuel ignition comprises metal-containing oxidant, at least one metal reducing agent and at least one binder, and / or gelling agent and This can be facilitated by the use of an initiator composition comprising a mixture of additive substances such as / or binders. The initiator composition can include the same or similar reactants as those described herein including a metal oxidation / reduction fuel.

[042] In certain embodiments, the initiator composition includes one or more additive materials, for example, to facilitate processing, improve mechanical strength and / or determine combustion and sparking characteristics. be able to. Inactive additive materials do not react or react to minimize the extent during ignition and combustion of the initiator composition. This is advantageous when the initiator composition is used in a closed system where minimum pressure is useful. The additive substance is an inorganic substance and acts, for example, as a binder, adhesive, gelling agent, thixotrope and / or surfactant. Examples of gelling agents are clays such as LAPONITE, montmorillonite, CLOISITE, metal alkoxides represented by the chemical formulas R—Si (OR) _n and M (OR) _n (where n is 3 or 4 and M is titanium) , Zirconium, aluminum, boron or other metals), and transition metal hydroxides or oxide-based colloidal particles. Examples of binders include soluble silicates such as sodium silicate, potassium silicate, aluminum silicate, metal alkoxides, inorganic polyanions, inorganic polycations, inorganic sol-gel materials such as alumina or silica based sols. Including, but not limited to. Other effective additive materials include glass beads, diatomaceous earth, nitrocellulose, polyvinyl alcohol, guar gum, ethyl cellulose, cellulose acetate, polyvinyl pyrrolidone, fluorocarbon rubber (Viton) and other polymers that act as binders. In certain embodiments, the initiator composition can include a plurality of additive materials.

  [043] In certain embodiments, additive materials are effective in determining specific processing, ignition and / or combustion characteristics of the initiator composition. In certain embodiments, the particle size of the initiator component is tailored for purposes of ignition and combustion rate, as is known in the art, for example, as disclosed in US Pat. No. 5,739,460. Selected to do.

  [044] In certain embodiments, it is beneficial for the additive material to be inert. When sealed within the enclosure, the exothermic oxidation-reduction reaction of the initiator composition results in an increase in pressure depending on the components selected. In certain embodiments, such as portable medical devices, it is useful to include pyrogens and products of exothermic and other chemical reactions caused by the high temperatures generated within the enclosure.

  [045] In certain embodiments particularly suitable for use in medical applications, it is desirable that the additive material not be an explosive, such as, for example, nitrocellulose, as classified by the US Department of Transportation. In certain embodiments, the additive material is Viton or Laponite. These materials can bind to the components of the initiator composition and provide mechanical stability to the initiator composition.

  [046] The components of the initiator composition, including the metal reducing agent, metal-containing oxidant and / or additive material and / or any suitable aqueous or organic soluble binder may be any suitable physical or mechanical Can be mixed by various methods to obtain an effective level of dispersion and / or homogeneity. For ease of handling, use and / or application, the initiator composition can be prepared as a liquid suspension or slurry in an organic or aqueous solvent.

  [047] The ratio of the metal reducing agent to the metal-containing oxidant can be selected to determine the appropriate combustion and sparking characteristics. In certain embodiments, the initiator composition is prepared to maximize spark generation with sufficient energy to ignite the fuel. Sparks released from the initiator composition strike the surface of the fuel, such as oxidation / reduction fuel, and ignite the fuel in a self-supporting exothermic oxidation-reduction reaction. In certain embodiments, the total amount of energy released by the initiator composition ranges from 0.25J to 8.5J. In certain embodiments, a solid film of initiator composition 20 μm to 100 μm thick burns with a deflagration time in the range of 5 milliseconds to 30 milliseconds. In certain embodiments, a solid film of an initiator composition that is 40 μm to 100 μm thick burns with a deflagration time in the range of 5 milliseconds to 20 milliseconds. In certain embodiments, a solid film of initiator composition 40 μm to 80 μm thick burns with a deflagration time in the range of 5 milliseconds to 10 milliseconds.

[048] Examples of initiator compositions are: 10% Zr, 22.5% B, 67.5% KClO ₃ ; 49% Zr, 49% MoO ₃ , 2% nitrocellulose; 33.9% Al, 55. 4% MoO ₃ , 8.9% B, 1.8% nitrocellulose; 26.5% Al, 51.5% MoO ₃ , 7.8% B, 14.2% VITON1; 47.6% Zr, 47 A composition having 6% MoO ₃ , 4.8% LAPONITE. Here, all percentages are weight percent of the total amount of the composition.

  [049] Examples of high spark and low gas production initiator compositions include a mixture of aluminum, molybdenum trioxide, boron and Viton. In certain embodiments, these components can be bound to a mixture of 20-30% aluminum, 40-55% molybdenum trioxide, 6-15% boron, and 5-20% Viton. Here, all percentages are weight percent of the total amount of the composition. In certain embodiments, the initiator composition comprises 26-27% aluminum, 51-52% molybdenum trioxide, 7-8% boron, and 14-15% Viton. Here, all percentages are weight percent of the total amount of the composition. In certain embodiments, aluminum, boron and molybdenum trioxide are in the form of nanoscale particles. In a particular embodiment, Viton is Viton A500.

  [050] In certain embodiments, the impact initiator composition is a reduction of a powder having a powdered metal-containing oxidant and a central metal core, eg, as described in US Pat. No. 6,666,936. A composition containing an agent, a metal oxide layer surrounding the central core, and a fluoroalkylsilane surface layer can be included.

  [051] In general, the initiator composition is prepared as a liquid suspension in an organic or aqueous solvent to coat the anvil, and a soluble binder is generally included to adhere the coating to the anvil.

  [052] The coating of the initiator composition is applied to the anvil in a variety of known ways. For example, the anvil is immersed in a slurry of the initiator composition and then dried or heated in air to remove the liquid, producing a solid adhesive coating having the desired properties as described above. In certain embodiments, the slurry is sprayed or spin coated onto the anvil and then processed to provide a solid coating. The coating thickness of the initiator composition on the anvil is such that when the anvil is placed in the enclosure, the initiator composition is a slight distance from the inner wall of the enclosure about a thousandths of an inch, such as 0.004 inches. You just need to be away.

  [053] Actuation of the initiator composition by impact causes the enclosure to deform inwardly toward the anvil by applying a strong mechanical impact or blow to the sides of the enclosure, and the coating of the initiator composition is Can be operated by pressing against. A mechanical shock sufficient to deform the tube can be achieved by any suitable mechanism.

  [054] In certain embodiments, the mechanical impact is provided by, for example, but not limited to, the release of a biased torsion spring, compression spring, or leaf spring. Such a mechanism is known as a mechanism for impact ignition of a flash bulb as disclosed in, for example, US Pat. No. 4,146,356. For example, FIGS. 2A-2D illustrate a mechanism for operating a shock-ignited system. The pre-biased torsion spring 22 is mounted on the torsion spring holder 24 in proximity to the impact actuation igniter 32 (FIG. 2A). The impact actuation igniter 32 includes a sealed enclosure 34 and an anvil 36 that is coaxially disposed within the enclosure 34 and is held in place by a recess. Initiator composition 40 is disposed on a portion of anvil 36. In the position before release, the striker arm 26 of the torsion spring 22 is placed on the mechanical stopper 28 (FIG. 2A). The engagement member 30 is configured to push the striker arm 26 away from the mechanical stopper 28 and release the striker arm 26 (FIGS. 2A and B). The stress in torsion spring 22 drives striker arm 26 and impacts enclosure 34 proximate to initiator composition 40 placed on anvil 36 (FIG. 2C). Due to the impact force generated by the striker arm 26, the wall surface of the enclosure 34 is deformed toward the anvil 36 (FIG. 2D). Compression of the initiator composition 40 between the deformed enclosure wall 42 and the anvil 36 causes the initiator composition 40 to rapidly burn and release a spark 43.

  [055] For use of an inhalation device, a mechanical impact mechanism, such as a biased torsion spring shown in FIG. 2, is coupled to the inhalation sensing mechanism so that when the patient inhales through the medical device, An impact ignition system can be activated. The inhalation sensing mechanism includes a mechanism for sensing pressure or air flow. The inhalation device includes a housing defining an air passage having at least one air inlet and a mouthpiece having at least one air outlet. As the patient inhales over the mouthpiece, an air flow is generated in the air path. The velocity of the air flow in the air path is detected by an air flow velocity transducer such as a thermistor or mass flow sensor. The air flow through the air path also creates a pressure difference between the outside and the inside of the air path. The pressure difference is detected by a pressure transducer such as a diaphragm.

  [056] An air flow sensing actuator for operating the impact igniter is illustrated in FIGS. 3A is an isometric view of the airflow sensing actuator and FIG. 3B is a cross-sectional view. FIG. 3 shows the diaphragm 42 incorporated in the housing 44. The housing 44 defines an air passage 46 having an air inlet 48 and an air outlet 50. The first side 52 of the diaphragm 42 is fluidly coupled to the air passage 46 and the second side 54 of the diaphragm 42 is mechanically coupled to a lever arm assembly 56 that is open to the ambient environment. The lever arm assembly 56 includes a base 58 fixed to the second side 54 of the diaphragm 42, a pivot 60 that attaches the base 58 to the lever arm 62, and a support base 64 that connects the lever arm 62 to the engagement arm 66. . Due to the pressure difference between the two sides of the diaphragm 42 caused by the air flow in the air passage 46, the diaphragm 42 is pulled toward the air passage 46. The movement of the diaphragm 42 is converted through the mechanical lever and support base assembly 56 to move the engagement arm 66 horizontally. The engagement arm 66 returns to its original position when air stops flowing through the air passage 46. The relative movement of the engagement arm 66 can be used to release a pre-biased torsion spring, for example, as shown in FIGS. For example, as shown in FIGS. 2A-2D, the relative movement of the engagement arm 66 pushes the striker arm 26 away from the mechanical stop 28, thereby releasing the striker arm 26 and impacting the enclosure 34. be able to. In certain embodiments, the movement of the engagement arm itself can provide sufficient mechanical impact to actuate the initiator composition upon impact. As will be apparent to those skilled in the art, other mechanical mechanisms can be utilized to achieve relative movement of the engagement arms as the diaphragm deflects.

[057] Diaphragm 42 is a flexible membrane made from any suitable material. For example, the diaphragm 42 is a thin elastic membrane having a thickness in the range of 0.001 inch to 0.1 inch. Examples of suitable diaphragm materials include nitrile rubber, silicon rubber, thin metal, and the like. The mechanical force generated by the diaphragm is determined, at least in part, by the area of the diaphragm portion that is fluidly coupled to the air path and the velocity of the air flow in the air path that creates a pressure difference proportional to both sides of the membrane. Is done. For example, a diaphragm having a surface area of 1.75 in ² with a lever ratio of 2: 1 at a pressure drop of 10 cm H ₂ O generates about 220 grams of force. However, this force varies depending on, for example, the size and shape of the opening.

  [058] An inhalation-actuated impact ignition system can be used to ignite a fuel, such as a fuel including a metal reducing agent and a metal-containing oxidant. The metal oxidation-reduction fuel and impact ignition system can be incorporated into a small manufacturable heat package.

  [059] FIGS. 4A-4F illustrate an embodiment of a heat package comprising an impact igniter. The heat package 70 of FIGS. 4A-4F basically comprises a sealed tube or cylinder 76 having a first end 72 and a second end 74. For use in portable medical devices, it is important that the heat package remain sealed when ignited and withstand the internal pressure generated by the burning fuel. 4A and 4C-4F, the first end 72 of the heat package 70 is integral with or formed from the same body portion 76 of the tube. In FIG. 4B, the first end 72 is a separation portion and the second end 74 is a separation portion. Portions 72, 74 can be by any suitable means capable of withstanding the pressure and temperature generated during combustion of the igniter and fuel compound, such as by soldering, welding, crimping, adhesive fastening, mechanical bonding, etc. The contact surface 78 can be sealed. Second end 74 can also be sealed in a similar manner, and in certain embodiments can include an insert that is thermally conductive or non-conductive.

  [060] FIG. 4A illustrates one embodiment of a heat package 70 having a coaxially arranged anvil 80 held in place by recesses 86,87. The anvil 80 extends substantially the entire length of the heat package 70. A thin coating of the initiator composition 82 is disposed near one end of the anvil 80 and a coating of the metal oxidation / reduction fuel compound 84 disclosed herein is disposed at the other end of the anvil 80. The recess 87 provides a space between the anvil 80 and the inner wall of the tube 70, which creates a spark during the rapid combustion of the initiator composition 82 and strikes and ignites the fuel compound 84. The anvil 80 can include features that facilitate retention of larger amounts of fuel and / or facilitate assembly. For example, the end of the anvil 80 where the fuel 84 is disposed can include fins or saw shapes to increase the surface area.

  [061] FIG. 4B illustrates one embodiment of a heat package 70 having an anvil 90 that is shorter than the total length of the heat package 70. FIG. Anvil 90 is held coaxially within tube 92 by a recess 94 near one end of anvil 90. By minimizing or eliminating obstructions in the space between the anvil 90 and the inner wall of the tube 92, the ability of the spark emitted from the initiator composition 82 is promoted and the fuel 98 is hit. Can be ignited. The first and second portions 72, 74 forming the heat package 70 shown in FIG. 4B are sealed with a contact surface 78. Fuel 98 is disposed in the first portion 72. Due to the short anvil 90, the entire region within the first portion 72 can be filled with fuel 98.

  [062] In FIG. 4C, the anvil 100 includes fuel. Initiator composition 82 is disposed on a portion of anvil 100. Activation of the initiator composition 82 ignites the anvil 100. End portion 102 is made of a thermal insulation material to facilitate mounting of heat package 70. By using fuel that extends substantially the entire length of the heat package, a large effective heating range can be provided.

  [063] FIG. 4D illustrates one embodiment of a heat package 70, wherein the front end 104 of the anvil 106 is formed of a high pitch, thin walled auger that can be used, for example, to load the cylindrical end 72 with fuel. ing. Such a design is effective in facilitating the manufacture of heat packages.

  [064] FIG. 4E illustrates one embodiment of a heat package 70, where the anvil 90 extends a portion of the entire length of the tube 76 and the interior of the tube 76 is filled with fuel 90. Filling the majority of tube 76 with fuel 99 increases the amount of heat generated from heating package 70. As shown in FIG. 4F, in a particular embodiment, the fuel 99 is arranged as a layer on the inner wall of the tube 76 and the central region 97 is a space. The layer of fuel 99 facilitates the rapid heating of the tube 76 to reach even heating and / or maximum temperature by exposing a large surface area that can be ignited by the sparks emitted from the initiator composition 82. The space of the central region 97 provides a volume that allows the released gas to accumulate and reduce the internal pressure of the heat package 70.

  [065] The heat package as shown in FIGS. 4A-F can have any suitable dimensions, at least in part, determined by the surface area to be heated and the desired maximum temperature. Impact-actuated heat packages are particularly useful as small heating elements that can generate short thermal impulses that can be used, for example, to vaporize a drug and generate a condensed aerosol for inhalation. In such applications, the length of the heat package ranges from 0.4 inches to 2 inches and has a diameter ranging from 0.3 inches to 0.1 inches. The optimal size of the anvil, the size of the sealed cylinder and the amount of fuel placed therein for a particular application and / or use can be determined by standard optimization procedures.

  [066] FIG. 5 illustrates another embodiment of a heat package. The heat package 110 includes a first portion 112 that includes an impact ignition system and a second portion 114 that includes a fuel 116 and has a larger cross-sectional dimension than the first portion 112. The impact ignition system includes an anvil 118 that is coaxially disposed within deformable tube 112. One end 120 of the deformable tube is sealed and the opposite end 121 is coupled to the second portion 114. The anvil 118 is held in place by the recess 122. A portion of the anvil 118 is coated with the initiator composition 126. The second portion 114 includes an enclosure having a greater wall thickness and cross-sectional dimension than the first portion 112. Such a design increases the amount of fuel, increases the external surface area on which the material is placed, reduces the pressure in the enclosure by providing a volume in which the gas can expand, Providing a large surface area is effective for increasing the burning rate and / or improving the structural integrity of the first part. In FIG. 5, the fuel 116 is shown as a thin layer disposed along the inner wall of the second portion 114. Other fuel configurations are possible. For example, the fuel can be disposed only along a horizontal wall, can be wholly or partially filled with the interior region 124, and / or is disposed within a fiber matrix disposed throughout the interior region 124. It should be noted that the shape, structure and composition of the fuel 116 can be determined to suit a particular application, determined in part by the desired thermal profile.

  [067] FIG. 6 illustrates another embodiment of a heat package. The heat package shown in FIG. 6 is similar to the package shown in FIG. 5 with the basic difference that the deformable tube 112 protrudes into the region 124 of the second portion 114. The configuration shown in FIG. 6 is effective in enhancing and / or controlling the dispersion of sparks generated by the rapid combustion of the initiator composition 126. The heat package shown in FIG. 6 further shows a substance 128 disposed on the outer surface of the second portion 114. As described herein, impact initiator composition 126 ignites fuel 116. Heat generated by the combustion of the fuel 116 is transferred to the second portion 114 and can vaporize the substance 128.

  [068] The fuel can include a metal reducing agent and an oxidizing agent, such as, for example, a metal-containing oxidizing agent.

[069] In certain embodiments, the fuel may comprise a mixture of Zr and _MoO 3, Zr and _Fe 2 _O 3, Al and MoO _3, or Al and _Fe 2 _{O 3.} In certain embodiments, the amount of metal reducing agent can range from 60% to 90% by weight and the amount of metal-containing oxidizing agent can range from 40% to 10% by weight.

  [070] Examples of metal reducing agents effective to form fuel include molybdenum, magnesium, calcium, strontium, barium, boron, titanium, zirconium, vanadium, niobium, tantalum, chromium, tungsten, manganese, iron, cobalt, Including but not limited to nickel, copper, zinc, cadmium, tin, antimony, bismuth, aluminum and silicon. In certain embodiments, the metal reducing agent can be selected from aluminum, zirconium and titanium. In certain embodiments, the metal reducing agent can include a plurality of metal reducing agents.

[071] In certain embodiments, the oxidant that forms the fuel can include oxygen, an oxygen-based gas, and / or a solid oxidant. In certain embodiments, the oxidant includes a metal-containing oxidant. In certain embodiments, metal-containing oxidants include, but are not limited to perchlorate and transition metal oxides. Perchlorate salts include, but are not limited to, potassium perchlorate (KClO ₄ ), potassium chlorate (KClO ₃ ), lithium perchlorate (LiClO ₄ ), sodium perchlorate (NaClO ₄ ) and perchloric acid. Alkali metal or alkaline earth metal perchlorate, such as magnesium (Mg (ClO ₄ ( ₂ )), etc. In certain embodiments, the transition metal oxide that acts as an oxidizing agent is molybdenum, such as MoO _3. , Iron such as Fe ₂ O ₃ , vanadium such as V ₂ O ₅ , chromium such as CrO ₃ and Cr ₂ O ₃ , manganese such as MnO ₂ , cobalt such as Co ₃ O ₄ , silver such as Ag ₂ O, CuO copper, such as tungsten, such as WO _3, magnesium such as MgO, niobium, such as _Nb 2 _{O 5,} including oxides, limited to these Not. In certain embodiments, the metal-containing oxidizing agent can include a plurality of metal-containing oxidizing agent.

[072] In certain embodiments, the metal reducing agent to form a solid fuel can be selected from zirconium and aluminum, the metal-containing oxidizing agent can be selected from MoO ₃ and Fe ₂ O _3.

[073] By selecting the ratio of the metal reducing agent to the metal-containing oxidant, the ignition temperature and combustion characteristics of the solid fuel can be determined. An exemplary chemical fuel, in weight percent, contains 75% zirconium and 25% MoO ₃ . In certain embodiments, the amount of metal reducing agent ranges from 60% to 90% by weight of the total dry weight of the solid fuel. In certain embodiments, the amount of metal-containing oxidant ranges from 10% to 40% by weight of the total dry weight of the solid fuel.

[074] In certain embodiments, the fuel includes one or more additive substances, thereby facilitating processing and / or during and following the ignition of the fuel, for example, the thermal properties of the heating unit and Time characteristics can be determined. The additive material is an inorganic material and acts as a binder, adhesive, gelling agent, thixotropy and / or surfactant. Examples of gelling agents are clays such as Laponite, montmorillonite, Cloisite, metal alkoxides represented by the chemical formulas R—Si (OR) _n and M (OR) _n, where n is 3 or 4 and M is titanium, zirconium , Aluminum, boron and / or other metals), and transition metal hydroxides or oxide-based colloidal particles. Examples of binders include soluble silicates such as sodium silicate, potassium silicate, aluminum silicate, metal alkoxides, inorganic polyanions, inorganic polycations, inorganic sols such as alumina or silica based sols. Including but not limited to gel materials. Other effective additive materials include glass beads, diatomaceous earth, nitrocellulose, polyvinyl alcohol, guar gum, ethyl cellulose, cellulose acetate, polyvinyl pyrrolidone, fluorocarbon rubber (VITON) and other polymers that act as binders.

  [075] Other effective additive materials include glass beads, diatomaceous earth, nitrocellulose, polyvinyl alcohol and other polymers that act as binders. In certain embodiments, the fuel can include a plurality of additive substances. The components of the fuel, including metals, oxidants and / or additive substances and / or any suitable aqueous or organic soluble binder, can be mixed and effective by any suitable physical or mechanical method. A level of dispersibility and / or homogeneity can be achieved. In certain embodiments, the fuel is vented.

  [076] The fuel in the heating unit can be any suitable shape and can have any suitable dimensions. The fuel is prepared as a solid form such as a cylinder, pellet or tube and inserted into a heat package. The fuel is deposited in the heat package as a slurry or float that is subsequently dried to remove the solvent. The fuel slurry or suspension is rotated while drying and depositing fuel on the inside surface of the heat package. In certain embodiments, the fuel is deposited on a support such as an anvil by a suitable method (eg, including the methods disclosed herein for coating an initiator composition on the anvil). Can be coated.

  [077] In certain embodiments, the anvil can be formed from a flammable metal alloy or metal / metal oxide compound, such as Pyrofuze (available from Sigmad Cohn), as is known in the art. Examples of fuel compounds suitable for the formation of anvils are disclosed in US Pat. Nos. 3,503,814, 3,377,955 and PCT Application Publication No. 93/14044. Which is incorporated herein by reference. In each embodiment, when the anvil is formed from a combustible material, no additional fuel other than the initiator is required.

  [078] In certain embodiments, the fuel is supported by a flexible fiber matrix that can be packed into a heat package. A fuel containing a metal reducing agent and a metal-containing oxidant can be mixed with the fibrous material to form a flexible fibrous fuel trick. Fibrous fuel matrix is a convenient fuel configuration that facilitates production and can achieve high burning rates. A fibrous fuel matrix is a paper-like composition comprising a metal oxidant and a metal-containing reducing agent in powder form supported by an inorganic fiber matrix. The inorganic fiber matrix is formed from inorganic fibers, such as ceramic fibers and / or glass fibers. To form the fibrous fuel, the metal reducing agent, the metal-containing oxidant and the inorganic fiber material are mixed together in a solvent and formed into a certain shape or sheet using, for example, a papermaking machine and dried. Fibrous fuels can also be formed into mats or other shapes that can facilitate manufacturing and / or combustion.

  [079] The heat package can have any suitable dimensions. Built-in heat packages are particularly suitable for applications where small size and safety are effective (eg, medical device applications). In certain embodiments, the overall length of the heat package can range from 0.8 inches to 2 inches and the width of the heat package can range from 0.02 inches to 0.2 inches. In certain embodiments, the width of the anvil can range from 0.005 inches to 0.19 inches.

  [080] The built-in heat package applies mechanical shock to the enclosure with sufficient force to deform a portion of the enclosure in the direction of the anvil (the initiator composition is then compressed between the tube and the anvil) ) Is ignited by impact. Abrupt combustion of the initiator composition is initiated by the compressive force. Sparks generated during rapid combustion are directed toward the fuel composition, and by bombarding it, the fuel composition is ignited by a self-supporting metal oxidation reaction that produces a fast, powerful thermal impulse.

  [081] In certain embodiments, the material is disposed on the outer surface of the heat package that is activated by impact. When activated, the heat generated by the combustion of the fuel can generate a high-speed, powerful thermal impulse that can vaporize a solid thin film of material disposed on the outer surface of the heat package with minimal degradation. The solid thin film of material can coat the outer surface of the heat package by any suitable method, depending in part on the physical properties of the material and the final thickness of the coating layer. In certain embodiments, methods for coating a heat package with a material include, but are not limited to, brushing, dip coating, spray coating, screen printing, roller coating, ink jet printing, vapor deposition, spin coating, and the like. . In certain embodiments, the material includes at least one solvent and is prepared as a solution that is applied to the outer surface of the heat package. In certain embodiments, the solvent comprises a volatile solvent such as acetone or isopropanol. In certain embodiments, the material is applied to the heat package as a melt. In certain embodiments, the material is applied to a film having a release coating and transferred to a heat package. For substances that are liquid at room temperature, a viscous composition comprising a substance that can be applied to a support by any suitable method, including the methods disclosed herein, by mixing a thickener with the substance. Can be generated. In certain embodiments, the layer of material is formed during a single application, or formed between repeated applications, increasing the final thickness of the layer.

  [082] In certain embodiments, the substance placed on the heat package can include a therapeutically effective amount of at least one physiologically active compound or drug. A therapeutically effective amount refers to an amount sufficient to effect treatment when administered to a patient or user in need of treatment. Treatment or treatment of any illness, symptom or disease is to stop or improve the progression of the illness, symptom or disease, reduce the risk of falling into a illness, symptom or disease, illness, symptom or disease, or illness, It refers to reducing the progression of at least one of the symptoms or clinical symptoms of the disease, or reducing the risk of progression of at least one of the disease, symptoms or disease, or clinical symptoms of the disease or disease. Treatment or treatment is the suppression of a disease, symptom, or disorder, either physically (eg, stabilization of distinguishable signs) or physiological (eg, stabilization of physical parameters), or both, It also refers to suppressing at least one physical parameter that may not be identifiable by the patient. Furthermore, a treatment or treatment is a disease in a patient who may be exposed to or likely to be affected by a disease, symptom, or disorder, even if the patient has not experienced or represented any signs of the disease, symptom, or disorder. , Delaying the onset of symptoms or diseases, or at least one symptom thereof.

  [083] In certain embodiments, the amount of material placed on the support is less than 100 micrograms, in certain embodiments less than 250 micrograms, in certain embodiments, Less than 000 micrograms. In certain embodiments, the thickness of the solid film applied to the heat package is in the range of 0.01 μm to 20 μm, and in certain embodiments, in the range of 0.5 μm to 10 μm.

  [084] In certain embodiments, the substance can include a pharmaceutical product. In certain embodiments, the substance can include a therapeutic compound or a non-therapeutic compound. Non-therapeutic compounds are compounds that can be used for recreational, experimental or preclinical purposes. The categories of drugs that can be used include, but are not limited to, anesthetics, anticonvulsants, antidepressants, antidiabetics, antidotes, antiemetics, antihistamines, antiinfectives, antineoplastics, antiparkinson Disease drug, antirheumatic drug, antipsychotic drug, anxiolytic drug, appetite stimulant and inhibitor, blood modifying agent, cardiovascular agonist, central nervous system drug, drug for treating Alzheimer's disease, cystic fibrosis treatment, diagnosis , Dietary supplement drugs, erectile dysfunction drugs, gastrointestinal drugs, hormones, drugs for the treatment of alcoholism, addiction treatment drugs, immunosuppressants, mast cell stabilizers, migraine preparations, motion sickness preparations, multiple occurrences Sclerosis drugs, muscle relaxants, nonsteroidal anti-inflammatory drugs, opioids, other analgesics and stimulants, eye drops, osteoporosis drugs, prostaglandins, respiratory drugs, sedatives and hypnotics, skin And mucosal agents, prohibited Adjuvants, Tourette's syndrome agents, urinary tract drugs, including dizziness drugs.

  [085] The degree and cause of thermal degradation depends, at least in part, on the particular compound, but in certain embodiments, the material is rapidly brought to a temperature sufficient to vaporize and / or sublime the active agent. Heating can minimize thermal degradation. In certain embodiments, the material is less than 500 milliseconds to a temperature of at least 250 ° C., in certain embodiments, less than 100 milliseconds to a temperature of at least 250 ° C., and in certain embodiments, 250 milliseconds. It can be heated to a temperature of at least 250 ° C. in less than a second.

  [086] In certain embodiments, rapid vaporization of a layer of material can produce a condensed aerosol that exhibits a high purity material with minimal thermal decomposition of the material. For example, in certain embodiments, less than 10% of material is decomposed during thermal evaporation, and in certain embodiments, less than 5% of material is decomposed during thermal evaporation.

  [087] Examples of agents that are evaporated from a heated surface to produce a high purity aerosol include albuterol, alprazolam, apomorphine HCl, aripiprazole, atropine, azatazine, benztropine, bromazepam, brompheniramine, budesonide, bumetanide, Buprenorphine, Butorphanol, Carbinoxamine, Chlordiazepoxide, Chlorpheniramine, Ciclesonide, Klemastine, Clonidine, Colchicine, Cyproheptadine, Diazepam, Donepezil, Eletriptan, Estazolam, Estradiol, Fentanyl, Flumazenil, Flunitramide, Flunisorfide Triptan, Galantamine, Granisetron, Hydromorphone, Hyoscyamine, Eve Lido, ketotifen, loperamide, melatonin, metaproterenol, methadone, midazolam, naratriptan, nicotine, oxybutynin, oxycodone, oxymorphone, pergolide, perphenazine, pindolol, pramipexole, prochlorperazine, rizatriptan, ropinirole, scopolamine, selegiline Includes tadalafil, terbutaline, testosterone, tetrahydrocanabinol, tolterodine, triamcinolone acetonide, triazolam, trifluoperazine, tropisetron, zaleplon, zolmitriptan, zolpidem. These drugs have a thickness in the range of 0.2 μm to 7 μm and a coating mass in the range of 0.2 mg to 40 mg when the drug thin film is heated to a temperature in the range of 250 ° C. to 550 ° C. in less than 100 milliseconds. Vaporized from a thin film, it can produce aerosols with drug purity greater than 90%, often greater than 99%.

  [088] Embodiments of the invention can be further clarified with reference to the following examples. The following examples describe in detail the preparation of the compounds of the invention. It will be apparent to those skilled in the art that numerous modifications can be made to both materials and methods without departing from the scope of the invention.

[Example 1]
Shock ignition using initiator composition
[089] The preparation of the heating unit according to Fig. 8 using impact ignition is described.

[090] To prepare an impact ignition system, a quarter portion of a thin stainless steel wire anvil was 26.5 wt% Al, 51.4 wt% based on dry weight in amyl acetate. It was dip coated with an initiator composition of MoO ₃ , 7.7 wt% B and 14.3% wt Viton A500. The coated wire was then dried at 40-50 ° C. for 1 hour. The dried coated wire anvil was placed in a 0.003 inch thick aluminum igniter tube and one end of the tube was crimped to hold the wire approximately coaxially within the tube.

  [091] In another embodiment, the initiator composition comprises 620 parts by weight of titanium having a particle size of less than 20 um, 100 parts by weight of potassium chlorate, 180 parts by weight of red phosphorus, sodium chlorate Formed by binding 100 parts by weight, and 620 parts by weight of water, and 2% polyvinyl alcohol binder.

[Example 2]
Shock ignited heat package
[092] An ignition assembly comprising a 1/4 inch portion of a thin stainless steel wire anvil was dip coated with the initiator composition and dried at about 45-50 ° C for about 1 hour. The dried coated wire anvil was inserted into a 0.003 inch thick flexible wall aluminum tube. The tube was crimped to hold the wire anvil in place.

  [093] Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and examples of the disclosure of the invention described herein. The above specification and examples are illustrative only, and the true scope and spirit of the present disclosure is to be defined by the following claims.

It is a figure of an impact igniter. 1 is a diagram of an inhalation-actuated impact ignition system according to certain embodiments. FIG. 1 is a diagram of an inhalation-actuated impact ignition system according to certain embodiments. FIG. 1 is a diagram of an inhalation-actuated impact ignition system according to certain embodiments. FIG. 1 is a diagram of an inhalation-actuated impact ignition system according to certain embodiments. FIG. FIG. 6 is an illustration of an actuation mechanism comprising a diaphragm for actuating an impact igniter according to certain embodiments. FIG. 6 is an illustration of an actuation mechanism comprising a diaphragm for actuating an impact igniter according to certain embodiments. FIG. 3 is an illustration of an impact-actuated heat package according to certain embodiments. FIG. 3 is an illustration of an impact-actuated heat package according to certain embodiments. FIG. 3 is an illustration of an impact-actuated heat package according to certain embodiments. FIG. 3 is an illustration of an impact-actuated heat package according to certain embodiments. FIG. 6 is a diagram of another embodiment of a heat package. FIG. 6 is a diagram of yet another embodiment of a heat package.

Claims (45)

A housing defining an air passage and comprising a mouthpiece having at least one air inlet and at least one air outlet;
An air flow sensing actuator coupled to the air path;
A mechanism coupled to the air flow sensing actuator and configured to actuate an impact igniter;
With
An inhalation-actuated impact ignition system wherein the impact igniter is actuated by an air flow in the air path generated by inhalation through the mouthpiece.   The inhalation actuated ignition system of claim 1, wherein the air passage maintains an air flow rate in a range of about 10 L / min to about 200 L / min.   The inhalation actuated ignition system of claim 1, wherein the air flow sensing actuator is operated by pressure or air flow.   The inhalation actuated ignition system of claim 1, wherein the air flow sensing actuator operates with an air flow rate.   The inhalation actuated ignition system of claim 1, wherein the air flow sensing actuator is activated by a pressure differential.   The inhalation actuated ignition system of claim 5, wherein the air flow sensing actuator comprises a diaphragm.   The inhalation actuated ignition system of claim 6, wherein the pressure differential across the diaphragm due to the area of the diaphragm and the air flow generates sufficient mechanical force to operate the impact igniter.   The inhalation actuated ignition system of claim 1, wherein the mechanism configured to actuate the impact igniter generates a mechanical impact.   The mechanism configured to actuate the impact igniter comprises a spring, a mechanism for biasing the spring, and a mechanism for releasing the spring to apply a mechanical impact to the impact igniter. Item 2. The suction operation ignition system according to Item 1. The impact igniter is deformable,
An anvil disposed adjacent to the deformable portion;
An initiator composition disposed between the anvil and the deformable portion;
With
The inhalation actuated ignition system of claim 1, wherein the initiator composition is ignited when an impact on the deformable portion presses the initiator composition against the anvil.   The inhalation actuated ignition system of claim 10, wherein the initiator composition comprises at least one metal reducing agent, a metal-containing oxidizing agent, and at least one binder.   The inhalation actuated ignition system of claim 1, wherein the air flow sensing actuator activates the impact igniter when the air flow rate is at least 10 L / min. A method of operating an impact igniter,
A housing defining an air passage and comprising a mouthpiece having at least one air inlet and at least one air outlet;
An air flow sensing actuator coupled to the air path;
Providing an inhalation actuated impact ignition system comprising a mechanism coupled to the air flow sensing actuator and configured to actuate an impact igniter;
Generating an air flow in the air path by inhaling through the mouthpiece;
Activating the air flow sensing actuator;
Activating the impact igniter;
A method comprising: A housing defining an air passage and comprising a mouthpiece having at least one air inlet and at least one air outlet;
An air flow sensing actuator coupled to the air path;
A mechanism coupled to the air flow sensing actuator and configured to actuate an impact heating element;
A suction-actuated impact ignition system comprising:
The impact heating element comprises:
An enclosure with an area deformable by mechanical shock;
An anvil disposed within the enclosure;
An impact initiator composition disposed within the enclosure and configured to ignite when the deformable region of the enclosure is deformed;
A fuel arranged within the enclosure and configured to be ignited by the initiator composition;
With
An inhalation-actuated impact ignition system, wherein the impact heating element is actuated by an air flow in the air path generated by inhalation through the mouthpiece.   The heating element of claim 14, wherein a portion of the outer surface of the enclosure reaches at least 200 ° C. in less than 200 milliseconds after actuation of the impact igniter.   The heating element of claim 14, wherein the enclosure remains sealed after combustion of the fuel.   The heating element of claim 14, wherein the enclosure comprises a sealed tube.   The heating element of claim 14, wherein the enclosure comprises a metal.   The heating element of claim 14, wherein the deformable region of the enclosure is deformable with a force in the range of about 0.5 in-lb to about 3.0 in-lb.   15. A heating element according to claim 14, wherein the anvil comprises a solid rod, pin or wire.   The heating element of claim 14, wherein the anvil is coaxially disposed in the center of the enclosure.   The heating element of claim 14, wherein the anvil comprises the fuel.   15. A heating element according to claim 14, wherein the initiator composition comprises a metal-containing oxidant, at least one metal reducing agent, and a non-explosive binder.   The heating element of claim 14, wherein the initiator composition is disposed between an inner wall of the enclosure and the anvil.   The heating element of claim 14, wherein the initiator composition is disposed on a surface of the anvil.   15. A heating element according to claim 14, wherein the initiator composition does not contact the inner wall of the enclosure until the deformable region is deformed.   The heating element of claim 14, wherein the initiator composition is disposed on a surface of the anvil proximate to a deformable region of the enclosure.   The heating element of claim 14, wherein the fuel comprises at least one metal reducing agent and at least one metal-containing oxidant.   29. A heating element according to claim 28, wherein the fuel further comprises at least one inert material.   The heating element of claim 14, wherein the fuel comprises a mixture of a metal reducing agent, a metal-containing oxidant, and an inert fiber material.   31. A heating element according to claim 30, wherein the inert fiber material is glass fiber.   The heating element of claim 14, wherein the overall length of the enclosure ranges from about 0.8 inches to about 2 inches.   The heating element of claim 14, wherein the width of the enclosure ranges from about 0.02 inches to about 0.2 inches.   The heating element of claim 14, wherein the width of the anvil ranges from about 0.005 inches to about 0.19 inches.   The heating element of claim 14, wherein a solid film comprising a drug is disposed on at least a portion of the outer surface of the enclosure.   The drug is albuterol, alprazolam, apomorphine HCl, aripiprazole, atropine, azatazine, benztropine, bromazepam, brompheniramine, budesonide, bumetanide, buprenorphine, butorphanol, carbinoxamine, chlordiazepoxide, chlortiniramine, cretinocirine, Cyproheptadine, diazepam, donepezil, eletriptan, estazolam, estradiol, fentanyl, flumazenil, flunisolide, flunitrazepam, fluphenazine, fluticasone propionate, furovatriptan, galantamine, granisetron, hydromorphone, hyoscylamine, ibetitolide, ibetiroto , Methadone, midazolam, naratriptan, nicotine, oxybutynin, oxycodone, oxymorphone, pergolide, perphenazine, pindolol, pramipexole, prochlorperazine, rizatriptan, ropinirole, scopolamine, selegiline, tadalafil, terbutaline, testosterone, tetrahydrocaninol 36. The heating element of claim 35, wherein the heating element is selected from at least one of: tolterodine, triamcinolone acetonide, triazolam, trifluoperazine, tropisetron, zaleplon, zolmitriptan, zolpidem.   36. The heating element of claim 35, wherein the thickness of the solid thin film ranges from about 0.1 [mu] m to about 20 [mu] m. A suction-actuated heating system,
A housing defining an air passage and comprising a mouthpiece having at least one air inlet and at least one air outlet;
An air flow sensing actuator coupled to the air path;
A mechanism coupled to the air flow sensing actuator and configured to actuate an impact heating element;
A heating element comprising a fuel configured to be ignited by the impact igniter;
With
A heating system in which the impact igniter is activated by an air flow in the air path generated by inhalation through the mouthpiece.   39. A heating system according to claim 38, wherein the heating element is disposed in the air path.   39. A heating element according to claim 38, wherein the air flow sensing actuator comprises a diaphragm.   39. A heating element according to claim 38, wherein the pressure differential across the diaphragm due to the area of the diaphragm and air flow generates sufficient mechanical force to operate an impact igniter.   40. The heating element of claim 38, wherein the mechanism configured to actuate the impact igniter generates a mechanical impact.   The mechanism configured to actuate the impact igniter comprises a spring, a mechanism for biasing the spring, and a mechanism for releasing the spring to apply a mechanical impact to the impact igniter. Item 34. The heating element according to Item 33. A method for operating a heating element comprising:
Generating an air flow by inhalation;
Activating an air flow sensing actuator disposed within the air flow;
Activating an impact igniter coupled to the air flow sensing actuator; igniting fuel;
A method comprising: A method for producing a condensed aerosol of a substance, comprising:
A housing defining an air passage and comprising a mouthpiece having at least one air inlet and at least one air outlet;
An air flow sensing actuator coupled to the air path;
A mechanism coupled to the air flow sensing actuator and configured to actuate an impact igniter;
A heating element disposed in the air path, the heating element being disposed in the enclosure, and an impact igniter disposed in the enclosure and configured to ignite the fuel. A heating element comprising:
Providing an inhalation-actuated heating element comprising a material disposed on at least a portion of the outer surface of the enclosure;
Generating an air flow in the air path by inhaling through the mouthpiece;
Activating the air flow sensing actuator;
Activating the impact igniter;
Igniting the fuel;
Vaporizing a material disposed on an outer surface of the enclosure to generate an aerosol containing the material in the air path;
A method comprising:

Images