A port is provided on a nebulizer for the addition of a plurality of drug solutions to a nebulizer without disassembling the nebulizer or interrupting the flow of drug.
The administration of nebulized drugs to patients on a mechanical ventilator is an important medical need. Challenges in the administration of nebulized drugs to patients on a medical ventilator include maximizing efficient delivery of the drug to the lungs of the patient and provision of properly humidified breathing gases. Inefficient drug delivery wastes drug product, which may be expensive, may cause unpredictable dosing to patients (too much or too little drug). As used herein, the term “nebulized” is also referred to as “atomized” or “aerosolized,” and all three terms are interchangeable.
In many instances more than one drug needs to be delivered simultaneously to a patient. Sometimes, one or more additional drugs need to be delivered at scheduled times without interrupting the delivery of another drug. It may be desirable to provide for the addition of multiple drugs to a nebulizer without requiring that the nebulizer be disassembled. Additionally, leaving the nebulizer intact during the addition of drugs may be desirable when the nebulizer is part of a ventilator breathing circuit wherein disassembling the nebulizer could involve interrupting the flow of breathing gases to a patient connected to a mechanical ventilator. Patients are only placed on mechanical ventilation if they have difficulty breathing on their own, so interrupting the operation of the ventilator even momentarily is undesirable. Prior art nebulizers such as disclosed in U.S. Patent Publication US 2015/0224278 A1, U.S. Pat. Nos. 5,355,872 and 8,561,607 B2 do not disclose this combination of features.
This disclosure provides a novel port assembly for the addition of more than one drug solution to a jet nebulizer having a drug reservoir and a vertical orientation. This input port allows a clinician to administer a plurality of drugs to a patient using a nebulizer on a breathing circuit with a mechanical ventilator without interrupting the integrity of the breathing circuit to add an additional drug solution to the nebulizer.
In an embodiment, a port assembly (130) is provided for the addition of more than one drug solution to a nebulizer (10) having a drug reservoir (30), wherein the nebulizer is used to administer drugs to a patient by inhalation, and the nebulizer is part of a breathing circuit connected a mechanical ventilator.
The port assembly may include a sleeve (140) having a branch (150), wherein the sleeve has a compression nut (142) at a proximal end adapted to mate with a male threaded port (15) integral with the body of nebulizer (10), wherein the port (15) is adapted as a channel for adding a drug solution to a nebulizer, wherein the male threaded port is on an upper portion of a nebulizer such that a liquid added to the nebulizer through the port will cascade into a drug solution reservoir (30) in the nebulizer.
The sleeve (140) may have a sealed distal end (116) and a tube (120) traversing longitudinally through the seal from the distal end to the proximal end, wherein a first drug solution can be added into the nebulizer through the tube (120) without disassembling the nebulizer or the compression nut on the sleeve.
The branch (150) on the sleeve defines a channel (152) at an approximately 45° angle with respect to the distal end of an axis defined by tube (120), and the channel provides for the addition of an additional drug solution into the nebulizer.
The branch may have a cap (160) having an opening (162) therein permitting the addition of the additional drug solution to the nebulizer, wherein the additional drug solution is added by syringe or respule, wherein a plug (164) is provided to prevent air leakage from the opening (162) when the opening is sealed and not in use to add an additional drug solution, and wherein a first drug solution and an additional drug solution can be added simultaneously to the nebulizer.
In an embodiment, the plug of the port assembly of is on a tether affixed to the nebulizer such that the plug remains attached to the nebulizer when the plug is removed to expose the opening in the cap for the addition of a drug solution.
In an embodiment, the port assembly has a sleeve with a branch and a compression nut adapted to mate with a male threaded port adapted as a channel for adding a drug solution to a nebulizer, which male threaded port is on an upper portion of a nebulizer, which allows for a liquid added to the nebulizer through the port to cascade into a drug solution reservoir in the nebulizer. The branch on the sleeve defines a channel at an approximately 45° (±10°) angle with respect to the distal end, and the channel provides for the addition of a second solution into the nebulizer. The branch has a cap with an opening permitting the addition of an additional drug solution added by syringe or respule to the nebulizer. A plug is provided to prevent air leakage from the opening when the opening is not being used to add an additional drug solution to the nebulizer. The plug is on a tether, which is affixed to the nebulizer in order for the plug to remain attached to the nebulizer when the plug is removed for the addition of a drug solution.
In an embodiment an axis through the center of the branch channel is oriented at a 30° to 80° angle from a vertical axis though the center of the nebulizer.
In an embodiment, a nebulizer is provided for the administration of a nebulized drug to a patient on a mechanical ventilator, wherein the nebulizer is part of a breathing circuit. The nebulizer may have a drug input port allowing a drug solution to be added to the nebulizer without disassembling the nebulizer and without interrupting the breathing circuit, and wherein the input port has male threads.
In an alternative embodiment, a port assembly is provided for the addition of a drug solution to a nebulizer having a drug reservoir. The port assembly of this embodiment has a cap with a sealed distal end and a tube traversing longitudinally through the seal from the distal end to a proximal end, wherein a drug solution can be added into the nebulizer through the tube without disassembling the nebulizer, wherein the cap fits over a port adapted as a channel for adding a drug solution to a nebulizer such that a liquid added to the nebulizer through the port will cascade into a drug solution reservoir in the nebulizer.
In an alternative embodiment, a cap assembly is provided for the addition of a drug solution to a nebulizer having a drug reservoir and a vertical orientation, comprising a cap having an opening therein permitting the addition of an additional drug solution added by syringe or respule to the nebulizer, wherein a plug is provided to prevent air leakage from the opening when the opening is not in use to add an additional drug solution, wherein the cap is connected to the nebulizer body with a tether.
Disclosed herein is a port assembly for the addition of more than one drug solution to a jet nebulizer having a drug reservoir and a vertical orientation, for the administration of one or more nebulized drugs to a patient requiring mechanical ventilation and in need of such one or more drugs. This invention provides for the addition of multiple drugs to the nebulizer without requiring that the nebulizer be disassembled. A method, such as disclosed herein, for adding a one or more drugs to a nebulizer without requiring disassembly of the nebulizer may be advantageous because drugs can be added continuously to a nebulizer without interrupting the flow of air or other breathing gases to the patient. Additionally, the inventive method allows drugs to be added continuously or over an extended period such as hours or days to the nebulizer while keeping the breathing circuit intact and delivering breathing gases to the patient at all times without interruption. As used herein, the term “nebulization” is synonymous with “aerosolization” or “atomization.”
An example of a jet nebulizer is that disclosed in WO2019/236896 A1, published 12 Dec. 2019. A nebulizer (11) from WO2019/236896 is shown in in
In the operation of the nebulizer, breathing gases from ventilator 200 enter the nebulizer at input airway 20 and exit the nebulizer, with or without nebulized drug, at output airway 22. A drug solution is held in a reservoir 30 for nebulization. Nebulization occurs when compressed air (240) is supplied to compressed air input port 40 (typically 2-6 L/min at 50 psig) which causes a Venturi effect from an air jet in Venturi section 50 that draws liquid from reservoir 30 into the Venturi where the liquid is nebulized by shear forces in the Venturi section (50). The Venturi effect and internal operation of a nebulizer such as used in this invention is explained in further detail in WO2019/236896. The nebulizer is termed a “jet nebulizer” because of the air jet.
If no compressed air is supplied to air input port 40, nebulization does not occur. Breathing gases can flow through the nebulizer regardless of whether nebulization is active or not. In an embodiment described in WO2019/236896, this nebulizer may be used in a breath actuated mode, in which a pressure sensor on a mechanical ventilation breathing circuit detects when an actual inhalation is occurring, as opposed to portions of the breathing cycle where the patient is exhaling or neither inhaling nor exhaling. In breath actuation mode, the compressed air input port 40 is toggled on only when the patient is inhaling. Thus, nebulization only occurs when the patient is actually inhaling. The jet nebulizer 11 as disclosed in WO2019/236896 is also termed a “breath enhanced” nebulizer, having an internal configuration that amplifies the Venturi effect and rate of nebulization of the drug solution.
Because of the arrangement of the reservoir, the Venturi section, and other internal features of nebulizers 10/11, these nebulizers are intended to be used in a generally vertical orientation as shown the drawings, with the input airway channel 21 on the top, and reservoir 30 on the bottom of nebulizer 10/11.
Nebulizer 11 may include a drug input port 12, that provides a means to add a drug solution to the nebulizer without the need to disassemble the nebulizer or interrupt a breathing circuit, even momentarily. In embodiments, the nebulizer may be a permanent part of a breathing circuit, meaning that once a patient is set up with a breathing circuit, the nebulizer is not removed for the entire duration of the treatment. When a drug solution is added through drug input port 12, the liquid cascades down to drug solution reservoir 30, where it is ready for nebulization.
Drug input port 12 may be further provided with plug 14 in
Another embodiment (10) of a jet nebulizer is shown in
An embodiment of a simple port cap 100 suitable for connection to threads 15 is shown in
An alternative embodiment (130) of the port assembly is depicted in
In an embodiment, port assembly 130 has a branch 150 on sleeve 140. Branch 150 defines channel 152. A center line C-C′ of channel 152 is oriented at an approximately 45° (±10°) angle (angle n,
In
In an embodiment, side port (branch) 150 is equipped with a cap assembly 161 having cap 160, which as depicted in
Additionally, a second tether 172 may be provided to keep the cap 160 attached to the nebulizer 10 body, so it remains in physical contact with the nebulizer body even when the cap is detached from branch 150. Also shown is loop 174 on tether 172 that loops over branch 150. Also shown is tab 170 that provides a finger grip for adding or removing assembly 161 from branch 150.
The value of the inventive port 130 is shown in
In this experiment, 10 mL per hour of a test solution (a first simulated drug) of 53.5 mL of normal saline labeled with 4390 μCi of Technetium 99m pertechnetate (Tc99m) was injected into the nebulizer though port 122 with a syringe pump. The nebulizer was primed with 2 mL of this solution at t=0. At t=30 minutes, a bolus of 3 mL of normal saline mixed with 1213 μCi of Tc99m, a simulated second drug, was injected though opening 162 on cap assembly 161 in position as shown in
The data shows a linear delivery of the infused simulated drug from 0-30 min, with a slope of about 0.06. When the bolus of the second drug was injected into the nebulizer at 30 minutes, a rapid increase in aerosol delivery was observed (slope=0.18) until the 3 mL of the second drug was consumed, then the underlying continuous infusion of the first drug continues until the end of the experiment, still at a linear drug delivery rate, with a slope of about 0.05. The volume of the bolus giving similar results is not critical. Bolus quantities of 1 mL to 6 mL (the capacity of the drug reservoir in the nebulizer) have been tested with favorable results.
This demonstrates that multiple drugs can be added to the nebulizer while it is in-line in a breathing circuit and linear nebulization rates are obtained. The inventive port allows a first drug to be added at a steady rate, and a second drug can be added through the branch port and be efficiently and linearly delivered to the patient, while leaving the nebulizer in place the entire time.
Some representative drugs that this invention may be useful for include epoprostenol and albuterol which may be added by infusion. Other drugs include gentamicin, tobramycin, and colistin which may be added as a bolus.
Filing Document | Filing Date | Country | Kind |
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PCT/US21/64554 | 12/21/2021 | WO |
Number | Date | Country | |
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63128618 | Dec 2020 | US |