Preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings.
Medicine
In the present specification, the “medicine” includes any physiological or pharmacological active substances having local or systemic effects on patients. The active substances to be administered include antibiotics, antiviral substances, antiepileptics, analgesics, antiphlogistics and bronchodilators, and also include viruses, any of which may be inorganic or organic compounds. The medicine referred to in the present specification also include medicines acting on peripheral nerves, adrenergic receptors, cholinergic receptors, skeletal muscles, the circulatory system, smooth muscles, the vascular system, synapse sites, nerve effector synapses, the endocrine system and hormone system, the immunological system, the genital system, the skeletal system, the autacoid system, the digestive system and excretory system, the histamine system and the central nervous system. For example, it may be selected from polysacchalides, steroids, hypnotics and sedatives, psychoactivating agents, tranquilizers, antispasmodics, muscle reluxants, antiperkinsonics, analgesics, antiphlogistics, muscle contractors, anti-infectious agents, antibiotics, antimicrobial agents, antimalarial agents, hormonal reactants inclusive of contraceptives, sympathetic-nerve stimulants, polypeptides, proteins capable of inducing physiological action, diuretics, lipid regulators, anti-androgenic agents, vermicides, neoplasmic agents, antineoplasmic agents, blood sugar reducers, nutrients and supplements, growth supplements, fats, anti-enteritis agents, electrolytes, vaccines, and diagnostic agents.
Examples of active substances useful in the present invention include, but are not limited to, insulins, calcitonins, erythropoietins (EPO), factor VIII, factor IX, Ceredase, Cerezyme, cyclosporins, granular colony stimulation factors (GCSF), α-1-proteinase inhibitors, elcatonins, GMCSF (granulocyte-macrophage colony-stimulating factors, growth hormones, HGH (human growth hormones), GHRH (growth hormone-releasing hormone), heparins, LMWH (low-molecular weight heparins), interferon α, interferon β, interferon γ, interleukin 2, LHRH (luteinizing hormone-releasing hormone), somatostatin, somatostatin analogues containing octreotide, vasopressin analogues, FSH (follicle-stimulating hormones), insulin-like growth factors, insulintropin, interleukin 1 receptor antagonists, interleukin 3, interleukin 4, interleukin 6, M-CSF (macrophase colony-stimulating factors), nerve growth factors, PTH (parathyroid hormones), thymosin α1, IIb/IIIa inhibitors, α1 antitrypsins, respiratory system symplast virus antibodies, CFTR (cystic fibrous transmembrane conductance regulator) genes, deoxyribonucleases, BPI (bacterial/permeability-increasing protein), anti-CMV (cytomegalovirus) antibodies, interleukin 1 receptors, 13 cis-retinoic acid, pentamidine isothionate, albuterol sulfate, metaproterenol sulfate, beclometasone dipropionate, triamcinolone acetamide, budesonide acetonide, ipratrobium bromide, flunisoride, fluticasone, cromolyn sodium, nicotine, lung surface-active agents, amphotericin B, ciprofloxasin, gentamycins, tobramycins, ergotamine tartrate, and analogues, agonists and antagonists of the foregoing. It may further have structure of a nucleic acid appearing as Beer's nucleic acid molecules; a nucleic acid relating to, or incorporated in, viral vectors, related viral particles, lipids or lipid-containing materials; and other nucleic acid of a type suited for transfection or transformation of plasmid DNA or RNA or cells, in particular, cells of lung alveoli regions. The above substances may have various forms of, e.g., soluble or insoluble charged or non-charged molecules, and components of molecular synthetic products or pharmacyologically acceptable bases. The above active substances (reactants) may be naturally occurring molecules, may be produced by recombination, or may be analogues of active substances (reactants) having naturally occurred or having been produced by recombination and at least one amino acid of which has been added or deleted. The above substances may further include attenuated viruses or inactivated viruses suited for use as vaccines.
A liquid medicine used in the present invention refers to a medicine in the form of a liquid or a liquid medium containing a medicine. The liquid medicine may contain any desired additive(s). The medicine in a liquid may be in the state of any of dissolution, dispersion, emulsification, suspension and slurry, and may more preferably stand homogeneous in the liquid.
In the case when the liquid medicine is used as the medicine, the chief medium of the liquid may preferably be water or organic matter. Taking account of the fact that the medicine is administered to living bodies, it is preferable that water is the chief medium.
Medicine Atomizing Means
In the present invention, the medicine ejection part (ejection head) has any desired ejection pressure generating element. More specifically, the principle of ejection includes, but is not limited to, powder ejection, an MDI system, a jet type nebulizer, an ultrasonic type nebulizer, a mesh type nebulizer, a cam push-out system and an inkjet system. The ejection pressure generating element may preferably be exemplified by an electrothermal transducer which provides the medicine with thermal energy or an electromechanical transducer which provides the medicine with mechanical energy. That is, methods for ejecting the medicine may be exemplified by a method in which the electrothermal transducer is used to provide the medicine with thermal energy to make the former ejected through an ejection nozzle (a thermal jet system), and a method in which vibratory pressure of an electromechanical transducer (e.g., a piezoelectric element) which provides the medicine with mechanical energy is used to make the medicine ejected through an ejection nozzle. Ejection methods may be selected in accordance with, e.g., the type of the medicine.
In the case when the thermal jet system is used, size precision and reproducibility of: nozzle diameter of the ejection nozzle, calories of heat pulses utilized for ejection, a micro-heater as the electrothermal transducer can be enhanced in respect of individual liquid ejection units. Hence, a narrow droplet diameter distribution can be achieved. In addition, production cost for the head can be so low that this system is highly adaptable to compact devices which require frequent replacement of heads. Accordingly, the medicine ejection device of such a thermal jet system is particularly preferred when the medicine ejection device is required to have portability and convenience.
The ejection head may be provided integrally with a medicine reservoir to set up a medicine ejection cartridge, or may be set up as a member separate from the medicine reservoir.
According to the inhaler of the present invention, the patient can always inhale the medicine having a constant particle diameter. Hence, the reproducibility of the efficacy of medicine can be achieved without decreasing the medicine to be inhaled, without care of any contamination due to adhesion of the medicine and without regard to use environment at the time of inhalation.
The inhaler of the present invention is so set up that the user can carry it, and has a memory means (a memory) which stores information concerned with each individual user, inclusive of information on user's medical records and prescription. Then, it is an inhaler which makes the user inhale the medicine and is provided with a means for atomizing or nebulizing a medicine having a high uniformity in particle size. It is so designed that the user can efficiently and sanitarily inhale the medicine through the suction port (a mouthpiece) in accordance with the information on prescription. Herein, in the present specification, the “flow path member” means a member that forms an air flow path which is a medicine passage extending in the inhaler from a medicine-ejected part to the suction port. That is, the space formed inside the flow path member corresponds to the “air flow path”.
In conventional inhalers, it has commonly be so set up that one end of the flow path member 3 is connected with the suction port 6 and, on the other end thereof, an opening (open-air intake) is provided so that air streams can be formed in the flow path member 3 when the user inhales the medicine through the suction port 6. In such an inhaler, the air streams on which the medicine is transported is the open air, and hence there has been a possibility of changes in particle diameter of the medicine depending on open-air environmental conditions (such as temperature and humidity).
In the present invention, the flow path member 3 and the suction port 6 may connectably be set up as separate members, or may integrally be set up.
The container 2 may preferably have flexibility so that it may inflate when the user blows and it may crush when the user inhales. Materials for the container 2 may include paper and vinyl. Aluminum foil, ethylene-vinyl alcohol copolymer resin (EVOH), polyvinylidene chloride (PVDC) and butyl rubber, which have a low gas permeability, are preferable in order to make it easy to keep temperature and humidity constant in the container. There are no particular limitations on how the container be folded. It may be folded irregularly, in bellows structure, or spirally. Such a foldable container 2 may preferably be in a size set appropriately depending on age, build or figure, lung capacity, and so forth.
Once the patient blows through the suction port, the container 2 inflates, thus the exhaled air can be stored therein (
In what is shown in
The medicine having a constant particle diameter which has always been atomized in the air flow path stands atomized into the air having constant temperature and humidity without regard to the temperature and humidity in surroundings of the device, and hence the amount of evaporation of the medicine is also always constant. Thus, the patient can always inhale a liquid droplet medicine having a constant particle diameter without regard to the temperature and humidity in surroundings of the device.
When the air is enclosed, it is necessary to enclose air at least the temperature or humidity of which is constant, and it is preferable to enclose air both the temperature and humidity of which are constant.
Immediately before inhalation by the patient, the container 2 in which the air is previously stored in a constant-temperature or constant-humidity environment is attached to the flow path member 3 by means of the adapter 12, thus the inhaler comes into the state shown in
The medicine having a constant particle diameter which has always been atomized in the air flow path stands atomized into the air having constant temperature and humidity without regard to the temperature and humidity in surroundings of the device, and hence the amount of evaporation of the medicine is also always constant. Thus, the patient can always inhale a liquid droplet medicine having a constant particle diameter without regard to the temperature and humidity in surroundings of the device.
Table 1 given at the end shows results obtained by examining particle diameters measured when water droplets of 3.0 μm in diameter which have been formed by atomization in respective environments come out of a mouthpiece. Sectional area of the mouthpiece was set to be 100 mm2; distance from the atomization part to the mouthpiece outlet, 0.04 m; and flow rate of air streams in the air flow path, 20 m/s. The atomization was so carried out that the liquid droplets were formed at a frequency of 1,000,000 droplets/s.
As shown in Table 1, the particle diameter of liquid droplets when coming out of the mouthpiece differs greatly depending on environment. If the particle diameter of liquid droplets inhaled differs, the rate of deposition of medicine to lungs differs every time the medicine is inhaled, to make the reproducibility of the efficacy of medicine not achievable. Where the atomization of liquid droplets is carried out into the air having always constant temperature and humidity without regard to the temperature and humidity in surroundings of the device, the liquid droplets can always have a constant particle diameter, and hence the reproducibility of the efficacy of medicine can be achieved.
The present invention is not limited to the above embodiments and various changes and modifications can be made within the spirit and scope of the present invention. Therefore, to apprise the public of the scope of the present invention, the following claims are made.
While the present invention has been described with reference to exemplary embodiments, it is to be understood that the invention is not limited to the disclosed exemplary embodiments. The scope of the following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.
This application claims the benefit of Japanese Patent Applications No. 2006-200189, filed Jul. 24, 2006 and No. 2007-152215, filed Jun. 8, 2007, which are hereby incorporated by reference herein in their entirety.
Number | Date | Country | Kind |
---|---|---|---|
2006-200189 | Jul 2006 | JP | national |
2007-152215 | Jun 2007 | JP | national |