LOW FLOW ADAPTOR TO DELIVER AEROSOLS VIA NASAL CANNULA WITHOUT CRASHOUT

Abstract

Device and method of use are described in which a housing is configured and coupled to an aerosol generator which delivers aerosol into an oxygen stream transporting both to a patient via a nasal cannula, in a way to minimize condensation at low liters per minute flow rate.

Claims

1. A device for delivery of aerosol along with supplemental oxygen from an oxygen supply to the nasal cannula of a patient, the device comprising: a. a housing, wherein the housing includes a base and a cylindrical wall, wherein the base and the cylindrical wall define a chamber through which supplemental oxygen is led, and b. two couplers, wherein the first of the two couplers is an inlet for supplemental oxygen supply into the chamber, wherein the second of the two couplers is an outlet for delivery of the supplemental oxygen supply containing an aerosol, wherein each of the two couplers is configured to engage a nasal cannula line, wherein chamber wall is configured to snugly fit to an aerosol delivery portion of a nebulizer, wherein the aerosol delivery portion of nebulizer is not positioned to act as a baffle to air flow between the two couplers, wherein there is no baffle or impediment to air flow and aerosol through adaptor, wherein the housing and couplers are designed to facilitate laminar flow.

2. The device of claim 1 wherein the adaptor including housing, base, cylindrical wall, and two couplers are integrally formed.

3. The device of claim 2 wherein the adaptor is formed using a 3D printer.

4. The device of claim 1 wherein each of the two couplers defines a conduit which includes a cylindrical portion along the length of a portion of the coupler.

5. The device of claim 1 wherein each of the two couplers defines a slightly larger cylindrical portion which starts at an abutment of the coupler and continues to the chamber.

6. The device of claim 1 wherein each of the two couplers also defines void which is generally shaped as an end of an ellipsoid.

7. The device of claim 6 wherein each void starts in the slightly larger cylindrical portion and terminates in the chamber.

8. The device of claim 7 wherein the chamber is fluidly connected to voids and all cylindrical portions.

9. The device of claim 1 wherein condensation of the aerosol is eliminated in the housing at 2 liters per minute flow rate.

10. The device of claim 1 wherein the condensation rate of the aerosol is around 20% or lower in the housing at 1 liter per minute flow rate.

11. The device of claim 1 wherein the condensation rate of the aerosol is around 10% or lower in the housing at 1 liter per minute flow rate.

12. The device of claim 1 wherein the condensation rate of the aerosol is less than 50% in the housing at 0.5 liters per minute flow rate.

13. The device of claim 1 wherein the condensation rate of the aerosol is less than 40% in the housing at 0.5 liters per minute flow rate.

14. The device of claim 1 wherein the nasal cannula is configured for use by a patient selected from the group consisting of Micro Preemie, Preemie, Newborn, and Infant.

15. A computer readable medium storing computer readable instructions which, when acted upon by a 3D printer, cause the 3D printer to print an adaptor comprising: a. a housing, wherein the housing includes a base and a cylindrical wall, wherein the base and the cylindrical wall define a chamber through which supplemental oxygen is led, and b. two couplers, wherein the first of the two couplers is an inlet for supplemental oxygen supply into the chamber, wherein the second of the two couplers is an outlet for delivery of the supplemental oxygen supply containing an aerosol, wherein each of the two couplers is configured to engage a nasal cannula line, wherein chamber wall is configured to snugly fit to an aerosol delivery portion of a nebulizer, wherein the aerosol delivery portion of nebulizer is not positioned to act as a baffle to air flow between the two couplers, wherein there is no baffle or impediment to air flow and aerosol through adaptor, wherein the housing and couplers are designed to facilitate laminar flow.

16. The medium of claim 15 further causing the 3D printer to print an adaptor wherein each void starts in the slightly larger cylindrical portion and terminates in the chamber.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The above-mentioned and other features of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:

[0028] FIG. 1 illustrates an exploded view of the adaptor and nebulizer.

[0029] FIG. 2 illustrates a perspective view of the adaptor and nebulizer.

[0030] FIG. 3 illustrates a cross sectional side view of the adaptor cutting through both couplers.

[0031] FIG. 4 illustrates cross sectional top view of the adaptor cutting through both couplers.

[0032] FIG. 5 illustrates an end view of the adaptor looking through both couplers.

[0033] FIG. 6 illustrates a perspective view of the adaptor coupled to cannula lines going to the nose of a patient.

[0034] Corresponding reference characters indicate corresponding parts throughout the several views. Although the drawings represent embodiments of the present disclosure, the drawings are not necessarily to scale and certain features may be exaggerated in order to better illustrate and explain the present disclosure.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0035] The embodiments disclosed below are not intended to be exhaustive or limit the disclosure to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may utilize their teachings.

[0036] Unless otherwise stated, a reference to a compound or component includes the compound or component by itself, as well as in combination with other compounds or components, such as mixtures of compounds.

[0037] As used herein, the singular forms a, an and the include the plural reference unless the context clearly dictates otherwise.

[0038] All publications, patents and patent applications cited herein, whether supra or infra, are hereby incorporated by reference in their entirety to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference.

[0039] Crashout is deposition of the compositions that are nebulized on the interior of the adaptor, tubing, and nasal cannula. Crashout reduces the concentration of the nebulized compositions delivered to the patient during treatment.

[0040] Low flow is a qualitative term to describes flow rates of about 1 L/min to 6 L/min, or alternatively anything less than 6 L/min.

[0041] Nebulizer 100 and adaptor 200 are illustrated in FIG. 1. Nebulizer 100 may be a vibrating mesh nebulizer sold by Aerogen (Chicago, Ill.) as Aerogen Solo (available online at www.aerogen.com/aerogen-solo-3/). Nebulizer 100 includes reservoir 102 which is capable of receiving a continuous feed and/or holding powder, fluid, liquid, or liquefiable formulation, the vibrating mesh 104, power cable receiver 120 to receive electrical power to drive the vibrating mesh 104, and the aerosol delivery portion 110.

[0042] Adaptor 200 comprises housing 210 and two couplers 220. Housing 210 includes base 212 and cylindrical wall 214. All parts of adaptor 200 including housing 210, base 212, cylindrical wall 214, and couplers 220 may be integrally formed using a 3D printer. Base 212 includes surface 216 so that adaptor 200 can be placed on a suitable surface, such as placing adaptor 200 horizontally on a flat surface like a table. Cylindrical wall 214 also defines opening 232 to accommodate aerosol delivery portion 110 of nebulizer 100. Opening 232 may be modified to accommodate other means to deliver aerosol or nebulized medicaments. In alternative embodiments, the means to deliver aerosol or nebulized medicament 300 may be a dry powder delivery device, or an aerosol delivery line from a compressor.

[0043] As best illustrated in FIG. 2 by one embodiment of the present disclosure, aerosol delivery portion 110 of nebulizer 100 is inserted into opening 232 of adaptor 200. Cylindrical wall 214 is configured to snugly fit to aerosol delivery portion 110 of nebulizer 100. Specifically, the aerosol delivery portion 110 may comprise collar 112 or neck 114 to facilitate mounting of the unit into opening 232 of adaptor 200. The interfitting may be a push fit with a portion of collar 112 located within opening 232 and a portion of neck 114 located outside of opening 232. This enables the unit of nebulizer 100 and adaptor 200 to be easily mounted and de-mounted, for example for cleaning. The neck 114 or collar 112 at least partially lines opening 232 of adaptor 200. Aerosol delivery portion 110 of nebulizer 100 is not positioned low enough in opening 232 to act as a baffle to air flow between couplers 220. Adaptor 200 is designed to pass all air flow and aerosol to the nasal cannula and ultimately to the patient. There is no sharp change in flow direction created by the presence of aerosol delivery portion 110.

[0044] As best illustrated in FIG. 3, couplers 220 are horizontally opposed with no sharp change in flow direction. Couplers 220 are also positioned at substantially the same level (z-direction) relative to each other to further minimize flow disturbance. Couplers 220 can be interchangeably used as an inlet or as an outlet for air flow. Couplers 220 are designed to snugly fit within a nasal cannula line 400 (FIG. 6). Couplers 220 include tapered ends 222, cylindrical shape 224 and abutments 226 to facilitate mating with nasal cannula line 400. Couplers 220 may be modified, such as in length and girth, to accommodate multiple sizes and shapes of nasal cannula lines.

[0045] Couplers 220 each define conduits 228. Conduits 228 include a cylindrical portion 223 along the length of the portion of the coupler 220 configured to engage a nasal cannula line 400. Conduits 228 also include a slightly larger cylindrical portion 229 which starts at the abutment 226 and continues to the opening 232 of the cylindrical wall 214. Each coupler 220 also defines void 221 which is generally shaped as an end of an ellipsoid.

[0046] As illustrated in FIGS. 3 and 4, housing 210 (FIG. 1) defines chamber 230 which is fluidly connected to voids 221 and cylindrical portions 223 and 229. Cylindrical portions 223 and 229 and voids 221 are fluidly connected allowing for air flow to travel in one coupler 220, specifically through cylindrical portion 224, through larger cylindrical portion 229, through void 221 and through chamber 230 and then out of adaptor through the other void 221, through the other larger cylindrical portion 229, through the other cylindrical portion 223 and out to through the other coupler 220. The interior of housing 210 and base 212 defining chamber and the interior walls 218 of couplers 220 are smooth and rounded to facilitate laminar flow. Furthermore, integrally formed parts facilitate laminar flow. Adaptor 200 configuration and facilitation of laminar flow permits laminar egress of aerosol into the cannula line minimizing turbulent flow, eddies or small packets, each of which can lead to condensate (aka rain out or crash out) forming as liquid droplets in chamber 230.

[0047] As best illustrated in FIGS. 2, 3 and 5, conduits 228 in couplers 220 are continuous with chamber 230 (FIG. 4). Aerosol delivery portion 110 of nebulizer 100 is not positioned low enough in opening 232 to act as a baffle to air flow between couplers 220. There is no sharp change in flow direction created by the presence of aerosol delivery portion 110 as illustrated by the lack of a portion of aerosol delivery portion 110 blocking air flow through adaptor 200.

[0048] As illustrated in FIG. 6, in one embodiment of the present disclosure, adaptor 200 is fitted with nebulizer 100, and fitted to nasal cannula line 400. Nebulizer 100 includes medicament 300. The medicament 300 is nebulized into aerosol, then the aerosol is passed into the air flow from gas supply 600 through adaptor 200, and then into canula line 400 where it is delivered to patient 500 by nasal cannula 410.

[0049] Adaptor 200 facilitates delivery in aerosol form of, for example, bronchodilators, including -agonists, muscarinic antagonists, epinephrine, surfactants; pain-relief medications including anesthetics; migraine therapies; anti-infectives; anti-inflammatories, steroids, including corticosteroids; chemotherapeutic agents; mucolytics; vasodilators; vaccines and hormones. In addition substances classified as anti-thrombogenic agents, anti-proliferative agents, monoclonal antibodies, anti-neoplastic agents, anti-mitotic agents, anti-sense agents, anti-microbial agents, nitric oxide donors, anti-coagulants, growth factors, translational promoter, inhibitors of heat shock proteins, biomolecules including proteins, polypeptides and proteins, oligonucleotides, oligoproteins, siRNA, anti-sense DNA and RNA, ribozymes, genes, viral vectors, plasmids, liposomes, angiogenic factors, hormones, nucleotides, amino acids, sugars, lipids, serine proteases, anti-adhesion agents including but not limited to hyaluronic acid, biodegradable barrier agents may also be suitable.

[0050] The medicament 300 may for example, comprise long-acting beta-adrenoceptor agonists such as salmeterol and formoterol or short-acting beta-adrenoceptor agonists such as albuterol.

[0051] The medicament 300 may be a long-acting muscarinic antagonists such as tiotropium (Spiriva) or short-acting muscarinic antagonists such as ipratropium (Atrovent).

[0052] Typical anti-infectives include antibiotics such as an aminoglycoside, a tetracycline, a fluoroquinolone; anti-microbials such as a cephalosporin; and anti-fungals. Examples of antibiotics include anti-gram-positive agents such as macrolides, e.g. erythromycin, clarithromycin, azithromycin, and glycopeptides, e.g. vancomycin and teicoplanin, as well as any other anti-gram-positive agent capable of being dissolved or suspended and employed as a suitable aerosol, e.g. oxazolidinone, quinupristin/dalfopristin, etc. Antibiotics useful as anti-gram-negative agents may include aminoglycosides, e.g. gentamicin, tobramycin, amikacin, streptomycin, netilmicin, quinolones, e.g. ciprofloxacin, ofloxacin, levofloxacin, tetracyclines, e.g. oxytetracycline, doxycycline, minocycline, and cotrimoxazole, as well as any other anti-gram-negative agents capable of being dissolved or suspended and employed as a suitable aerosol.

[0053] Anti-inflammatories may be of the steroidal such as budesonide or ciclesonide, non-steroidal, such as sodium cromoglycate or biological type.

[0054] Typical local anesthetics are, for example, Ropivacaine, Bupivacaine, levobupivacaine, and Lidocaine.

[0055] Chemotherapeutic agents may be alkylating agents, antimetabolites, anthracyclines, plant alkaloids, topoisomerase inhibitors, nitrosoureas, mitotic inhibitors, monoclonal antibodies, tyrosine kinase inhibitors, hormone therapies including corticosteroids, cancer vaccines, anti-estrogens, aromatase inhibitors, anti-androgens, anti-angiogenic agents and other anti-tumor agents.

[0056] Surfactant medications (sometimes referred to herein as surfactants) are protein-lipid compositions, e.g. phospholipids, that are produced naturally in the body and are essential to the lungs' ability to absorb oxygen. They facilitate respiration by continually modifying surface tension of the fluid normally present within the air sacs, or alveoli, that tube the inside of the lungs. In the absence of sufficient surfactant, these air sacs tend to collapse, and, as a result, the lungs do not absorb sufficient oxygen. Insufficient surfactant in the lungs results in a variety of respiratory illnesses in both animals and humans. Since most of these surfactant medications are animal-based, the current supply is limited, and although synthetic surfactants are available, their manufacture is both inexact and expensive. In addition, the surfactant medications are typically high in viscosity and are difficult to deliver to the patient's respiratory system. The increased efficiency of the adaptor of the present disclosure, and the smaller amount of medicament 300 required for a treatment according to the present disclosure, can be a substantial advantage when such scarce and expensive medicaments are employed. The combination of surfactant with other medicaments to improve distribution in the lung and body is also possible. Surfactants also possess the capacity to act as anti-adhesion agents.

[0057] An adaptor 200 of the present disclosure is tested to ensure the adaptor minimized condensate (aka rain out or crash out) forming as liquid droplets in chamber 230 at low flow rate. Table 1 discloses the amount of condensate collected in a horizontal housing 210 after 3 mL 0.9% nasal saline is nebulized into aerosol using an Aerogen ultrasonic nebulizer 100 coupled to adaptor 200 at ambient temperature of 68 F. Different sizes of nasal cannulas (NC) and liters per minute (LPM) flow rates are tested.

TABLE-US-00001 TABLE 1 amount of condensate collected in a horizontal housing 210 after 3 mL 0.9% nasal saline is nebulized into aerosol using an Aerogen ultrasonic nebulizer 100 coupled to adaptor 200 at ambient temperature of 68 F.: 0.5 LPM 1 LPM 2 LPM 3 LPM 4 LPM 5 LPM 6 LPM NEONATAL NC 1.2 ml 0.3 ml 0 ml 0 ml 0 ml 0 ml 0 ml RAM CANNULA 1 ml 0.2 ml 0 ml 0 ml 0 ml 0 ml 0 ml ORANGE RAM CANNULA BLUE 1.1 ml 0.3 ml 0. ml 0 ml 0 ml 0 ml 0 ml RAM CANNULA GREEN 1.3 ml 0.6 ml 0.1 ml 0 ml 0 ml 0 ml 0 ml RAM CANNULA WHITE 1.3 ml .6 ml 0.1 ml 0 ml 0 ml 0 ml 0 ml INFANT NC 1.3 ml 0.5 ml 0.1 ml 0 ml 0 ml 0 ml 0 ml PEDIATRIC NC 1.3 ml 0.7 ml 0.2 ml 0 ml 0 ml 0 ml 0 ml ADULT NC 0.9 ml 0.2 ml 0 ml 0 ml 0 ml 0 ml 0 ml

[0058] Ram Cannulas come in a variety of sizes and colors (Micro Preemie is White; Preemie is Green; Newborn is Blue; Infant is Orange) and are sold by Neotech (Valencia, Calif.) (available online at www.neotechproducts.com/product/neotech-ram-cannula/#).

[0059] Table 1 surprisingly shows that condensate is eliminated for some nasal cannulas at flow rates as low as 2 liters per minute. Table 1 also surprisingly shows that condensation rates are typically around 20% or lower at flow rates as low as 1 liter per minute. Table 1 also surprisingly shows that adaptor 200 did not result in a condensation rate as high as 50% even at 0.5 liters per minute flow rate.

[0060] While this disclosure has been described as having an exemplary design, the present disclosure may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains.