Product delivery devices and methods

Abstract

Devices, and methods for generating variable inhalable products (e.g., variable density, phase, and size products) are provided. Methods for treating or preventing a disorder in a subject using variable products generated by the devices are also provided herein. Additionally, inhalers and breathing systems comprising the devices are provided.

1 - 27 . (canceled) 
     
     
         28 . A method of producing inhalable products, comprising:
 heating a liquid product substrate having a first substrate volume in a vessel comprising a vessel aperture, wherein the aperture is in fluid communication with a first chamber having a proximal portion and a distal portion, and the fluid communication is provided through an aperture in the proximal portion of the first chamber, to produce a mixed product having both gas phase and liquid phase molecules and a second substrate volume that is greater than the first substrate volume.   
     
     
         29 . The method of  claim 28 , wherein heating the liquid product substrate comprises heating the liquid product substrate at a first heating rate of from about 0.001° C./min to 150° C./min. 
     
     
         30 . The method of  claim 28 , further comprising heating the mixed product in the first chamber, the vessel, or a combination thereof, to produce a gaseous product having more at least 80% gas phase molecules. 
     
     
         31 . The method of  claim 30 , further comprising heating the gaseous product in the first chamber, the vessel, or a combination thereof, to produce a heated gaseous product having a temperature at least 10% higher than the boiling point for the product substrate. 
     
     
         32 . The method of  claim 30 , further comprising allowing the gaseous product or heated gaseous product to cool to produce a heavy mist product, wherein the heavy mist product comprises particles or droplets having an average diameter of from about 3.5 microns to about 5 microns. 
     
     
         33 . The method of  claim 32 , wherein allowing the gaseous product or heated gaseous product to cool comprises allowing the gaseous product or heated gaseous product to pass into a second chamber in fluid communication with the first chamber, wherein the second chamber has a lower temperature than the first chamber, or wherein allowing the gaseous product or heated gaseous product to cool comprises allowing the gaseous product or heated gaseous product to pass into a breathing system, or wherein allowing the gaseous product or heated gaseous product to cool comprises allowing the gaseous product or heated gaseous product to pass into a subject's oral cavity. 
     
     
         34 . A method of treating a subject having a disorder or providing prophylaxis to a subject to prevent or reduce the severity of a developing disorder, comprising:
 delivering inhalable products to the subject through the delivery device according to  claim 45 , an inhaler comprising the delivery device of  claim 45 , or a breathing system comprising the delivery device of  claim 45 .   
     
     
         35 . The method of  claim 34 , wherein the inhalable products comprise one or more active agents selected from acetyl cysteine, aclidinium bromide, albuterol, albuterol sulfate, amikacin sulfate, amniotic fluid, an amnion tissue preparation, arformoterol sulfate, atropine sulfate, aztreonam, beclomethasone dipropionate, bitolterol mesylate, budesonide, ciclesonide, cromolyn sodium, desflurane, dexamethasone sodium phosphate, dornase alfa, enflurane, epinephrine, ergotamine tartrate, flunisolide, fluticasone propionate, fomoterol fumarate, glycopyrrolate, halothane, indacaterol maleate, iloprost, insulin, ipratropium bromide, isoetharine hydrochloride, isoflurane, isoproterenol hydrochloride, levalbuterol hydrochloride, levodopa, loxapine, mannitol, metaproterenol sulfate, methacholine chloride, mometasone furoate, nedocromil sodium, nicotine, nitric oxide, olodaterol hydrochloride, pentamidine isethionate, pentetate calcium trisodium, pentetate zinc trisodium, pirbuterol acetate, revefenacin, ribavirin, salmeterol xinafoate, sevoflurane, stem cells, a stem cell preparation, terbutaline sulfate, tetrahydrocannabinol, cannabidiol, tiotropium bromide, tobramycin, trimcinolone acetonide, umeclidinium bromide, vilanterol trifenatate, xenon xe-133, zanamivir, epinephrine, sodium chloride, interferon beta, interferon beta 1-b, interferon beta gene delivery, interferon beta-1a, a BKB2R antagonist (e.g., icatibant), a KLKB1 inhibitor (e.g., ecallantide), androgens (e.g., danazol and stanasolol), recombinant SERPING1 (e.g., berinert, cinryze, haegarda), vitamin D, a HAS2 or HAS3 inhibitor (e.g., hymecromone (4-methylumbelliferone)), timbetasin, and combinations thereof. 
     
     
         36 . The method of  claim 34 , wherein the disorder is a respiratory disorder or a non-respiratory disorder. 
     
     
         37 . The method of  claim 36 , wherein the respiratory disorder is selected from chronic obstructive pulmonary disease, asthma, acute asthma, chronic asthma, severe asthma, allergic asthma, bronchial asthma, intrinsic asthma, respiratory distress syndrome of the newborn, reversible respiratory disease, cystic fibrosis, bronchospasms, bronchitis, chronic bronchitis, bronchiectasis, alpha-1 antitrypsin emphysema, emphysema, associated cor pulmonale with pulmonary hypertension, right ventricular hypertrophy and right heart failure, pulmonary hypertension, interstitial lung disease, pulmonary fibrosis, pneumonia, interstitial pneumonia, a lung infection, idiopathic pulmonary fibrosis, cystic fibrosis, tuberculosis, severe acute respiratory syndrome, infection, pulmonary embolus, pulmonary arterial hypertension, pulmonary edema, pneumocystis pneumonia, SARS-CoV-2 infection, covid-19, acute respiratory distress syndrome, intensive care unit (ICU) syndrome, systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis, septic shock, or multiple organ dysfunction syndrome (MODS), cystic fibrosis, sarcoidosis, and combinations thereof, and wherein the non-respiratory disorder is selected from an autoimmune disease, a spondyloarthropathy, an intestinal disease, diabetes, a skin disease, a non-respiratory infection, a pain disorder, intensive care unit (ICU) syndrome, systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis, septic shock, or multiple organ dysfunction syndrome (MODS), cystic fibrosis, sarcoidosis, and combinations thereof. 
     
     
         38 . A method of treating a subject having a disorder, comprising:
 administering, to lung tissue of the subject, inhalable products, through the inhaler according to claim  23 , wherein the administering occurs through ambulatory inhalation of the inhalable products by the subject from the inhaler.   
     
     
         39 . The method of  claim 38 , wherein the disorder is a non-respiratory disorder or a respiratory disorder, and wherein the administering occurs simultaneously with or after acute treatment of a respiratory disorder. 
     
     
         40 . A method of providing maintenance treatment to a subject following an acute treatment of a respiratory disorder in the subject, comprising:
 administering, to lung tissue of the subject, through a delivery device or an inhaler comprising the delivery device, inhalable products, wherein the administering occurs after completion of acute treatment of the subject's respiratory disorder.   
     
     
         41 . The method of  claim 40 , wherein the administering occurs more than 1 day, more than 2 days, more than 3 days, more than 1 week, more than 2 weeks, more than 3 weeks, more than 6 weeks, more than 8 weeks, more than 10 weeks, or more than 15 weeks after the subject has been discharged from hospital care, downgraded from intensive care, downgraded from acute care, downgraded from critical care, or removed from acute care treatment. 
     
     
         42 . A method of regenerating or restoring respiratory tissue or respiratory function in a subject following an acute respiratory disorder in the subject, comprising:
 administering, to lung tissue of the subject, through a delivery device or through and inhaler comprising the delivery device, inhalable products comprising amniotic fluid, an amnion tissue preparation, or a combination thereof.   
     
     
         43 . The method of  claim 42 , wherein the respiratory disorder is selected from chronic obstructive pulmonary disease, asthma, acute asthma, chronic asthma, severe asthma, allergic asthma, bronchial asthma, intrinsic asthma, respiratory distress syndrome of the newborn, reversible respiratory disease, cystic fibrosis, bronchospasms, bronchitis, chronic bronchitis, bronchiectasis, alpha-1 antitrypsin emphysema, emphysema, associated cor pulmonale with pulmonary hypertension, right ventricular hypertrophy and right heart failure, pulmonary hypertension, interstitial lung disease, pulmonary fibrosis, pneumonia, interstitial pneumonia, a lung infection, idiopathic pulmonary fibrosis, cystic fibrosis, tuberculosis, severe acute respiratory syndrome, infection, pulmonary embolus, pulmonary arterial hypertension, pulmonary edema, pneumocystis pneumonia, SARS-CoV-2 infection, covid-19, and acute respiratory distress syndrome, intensive care unit (ICU) syndrome, systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis, septic shock, or multiple organ dysfunction syndrome (MODS), cystic fibrosis, sarcoidosis, and combinations thereof. 
     
     
         44 . The device of claim  20 , wherein the therapeutic agent is one or more active agents selected from acetyl cysteine, aclidinium bromide, albuterol, albuterol sulfate, amikacin sulfate, amniotic fluid, an amnion tissue preparation, arformoterol sulfate, atropine sulfate, aztreonam, beclomethasone dipropionate, bitolterol mesylate, budesonide, ciclesonide, cromolyn sodium, desflurane, dexamethasone sodium phosphate, dornase alfa, enflurane, epinephrine, ergotamine tartrate, flunisolide, fluticasone propionate, fomoterol fumarate, glycopyrrolate, halothane, indacaterol maleate, iloprost, insulin, ipratropium bromide, isoetharine hydrochloride, isoflurane, isoproterenol hydrochloride, levalbuterol hydrochloride, levodopa, loxapine, mannitol, metaproterenol sulfate, methacholine chloride, mometasone furoate, nedocromil sodium, nicotine, nitric oxide, olodaterol hydrochloride, pentamidine isethionate, pentetate calcium trisodium, pentetate zinc trisodium, pirbuterol acetate, revefenacin, ribavirin, salmeterol xinafoate, sevoflurane, stem cells, a stem cell preparation, terbutaline sulfate, tetrahydrocannabinol, cannabidiol, tiotropium bromide, tobramycin, trimcinolone acetonide, umeclidinium bromide, vilanterol trifenatate, xenon xe-133, zanamivir, epinephrine, sodium chloride, interferon beta, interferon beta 1-b, interferon beta gene delivery, interferon beta-1a, a BKB2R antagonist, a KLKB1 inhibitor, androgens, recombinant SERPING1, vitamin D, a HAS2 or HAS3 inhibitor, timbetasin, and combinations thereof. 
     
     
         45 . An inhalation delivery device comprising:
 a first chamber;   one or more heating plates, wherein at least a portion of the one or more heating plates is positioned adjacent to a proximal portion of the first chamber; and   one or more heating coils surrounding a distal portion of the first chamber and wherein the one or more heating plates are positioned such that the distance between a sidewall of the first chamber and the one or more heating plates decreases along a flow axis.