The present disclosure relates to methods and devices for providing a metered dose of aerosolized medication to a patient and, in particular, to an adapter for joining a medication-dispensing inhaler to an inline patient breathing or ventilation assembly.
Aerosolized medication is provided to patients to treat respiratory conditions and breathing disorders including but not limited to asthma, emphysema, and chronic obstructive pulmonary disease (COPD). Traditionally, such medications are provided using a medication inhaler (e.g., a metered dose inhaler) comprising a canister of pressurized medication, a discharge port for expelling the medication from the inhaler, and a mouthpiece. The patient places the mouthpiece between his/her lips and actuates the inhaler to discharge the medication into his/her mouth through the inhaler discharge port. As the medication is being dispensed, the patient inhales to draw the discharged fluid medication into his/her lungs. In some examples, aerosolization chambers can be attached to the inhaler mouthpiece to improve dispersion of the released medication. For some patients, aerosolization chambers help to ensure that dispensed medication is drawn through the mouth and into the patient's lungs.
Adapters and connectors for interfacing a metered dose inhaler to a patient breathing tube or ventilation assembly are also known. Exemplary adapters include the RTC 24-V adapter and the RTC 22-D adapter manufactured by Instrumentation Industries, Inc. of Bethel Park, Pa. The RTC 24-V adapter is illustrated in
However, there is a need for an inline adapter for a patient breathing tube assembly that can provide straight line delivery therethrough of an aerosolized medicament received from an inhaler aerosol discharge port or nozzle into a patient's inhalation breathing tube. For example, the adapter can be configured to accommodate a Combivent® Respimat® inhaler system including a cartridge containing ipratropium bromide and albuterol.
Non-limiting examples of the present invention will now be described in the following numbered clauses:
Clause 1: An inline adapter, comprising: an elongated hollow body comprising an open first end configured to be connected to an inspiratory port of a patient ventilation assembly, an open second end opposite the first end, and a sidewall extending therebetween defining an airflow channel; an inhaler port extending from the open second end of the adapter body configured to be connected to an inhaler; and an inspiratory branch comprising an open first end extending from an opening in the sidewall of the adapter body and an open second end configured to be connected to an inspiratory limb of the ventilation assembly, wherein a longitudinal central axis of the inspiratory branch is angled relative to a longitudinal central axis of the adapter body.
Clause 2: The adapter of Clause 1, wherein the longitudinal central axis of the inspiratory branch forms an angle of between about 30 degrees and about 60 degrees relative to the longitudinal central axis of the adapter body.
Clause 3: The adapter of Clause 1 or Clause 2, wherein the longitudinal central axis of the inspiratory branch forms an angle of about 45 degrees relative to the longitudinal axis of the adapter body.
Clause 4: The adapter of any one of Clauses 1-3, wherein the inhaler port comprises an elongated sidewall extending from the second end of the adapter body, the sidewall configured to be received within a mouthpiece of the inhaler and to cover air vents on the inhaler.
Clause 5: The adapter of Clause 4, wherein the sidewall of the inhaler port comprises an elliptical cross section.
Clause 6: The adapter of Clause 5, wherein the cross section of an elliptical opening has a major external diameter D4 ranging from about 0.5 inches to about 1.25 inches.
Clause 7: The adapter of any one of Clauses 1-6, wherein the inhaler port comprises an interior wall covering the open second end of the adapter body, the interior wall comprising an opening configured to align with a discharge port of the inhaler to permit fluid discharged from the inhaler to pass into the airflow channel of the adapter body.
Clause 8: The adapter of any one of Clauses 1-7, wherein the open first end of the adapter body is configured to receive an inspiratory port of a patient wye of the ventilation assembly.
Clause 9: The adapter of any one of Clauses 1-8, wherein the open second end of the inspiratory branch of the adapter is configured to be inserted in an open end of the inspiratory limb of the patient ventilation assembly.
Clause 10: The adapter of any one of Clauses 1-9, wherein an outer diameter of the open second end of the inspiratory branch of the adapter is about equal to an inner diameter of the open first end of the adapter body.
Clause 11: The adapter of any one Clauses 1-10, wherein a total longitudinal length of the adapter ranges from about 2 inches to about 4 inches.
Clause 12: The adapter of any one Clauses 1-11, wherein a length of a longest longitudinal side of the inspiratory branch ranges from about 1 inches to about 2.5 inches.
Clause 13: The adapter of any one of Clauses 1-12, wherein the opening in the sidewall of the adapter body extending to the inspiratory branch is an elliptical opening.
Clause 14: The adapter of any one of Clauses 1-13, further comprising a cap removably connected to the inhaler port.
Clause 15: The adapter of Clause 14, wherein the cap comprises a thermoplastic rubber material.
Clause 16. A ventilation assembly for providing breathing air and aerosolized medication to a patient, comprising: an inspiratory limb comprising medical tubing configured to be connected to an outflow port of a mechanical ventilator device; an expiratory limb comprising medical tubing configured to be connected to an inflow port of the ventilator device; a patient wye comprising a patient port connected to a patient portion of the ventilation assembly, an expiratory port connected to the expiratory limb, and an inspiratory port; and an inline aerosol adapter connected between the inspiratory port of the patient wye and the inspiratory limb, the adapter comprising: an elongated hollow body comprising an open first end connected to the inspiratory port of the patient wye, an open second end opposite the first end, and a sidewall extending therebetween defining an airflow channel in fluid communication with an airflow channel of the patient wye; an inhaler port extending from the open second end of the adapter body configured to be connected to an inhaler; and an inspiratory branch comprising an open first end extending from an opening in the sidewall of the adapter body and an open second end connected to the inspiratory limb, wherein a longitudinal central axis of the inspiratory branch is angled relative to a longitudinal central axis of the adapter body.
Clause 17: The assembly of Clause 16, wherein a longitudinal central axis of the expiratory limb is substantially parallel to the longitudinal axis of the adapter body.
Clause 18: The assembly of Clause 16 or Clause 17, further comprising the inhaler, wherein the inhaler comprises a single-dose inhaler or a multi-dose inhaler.
Clause 19: The assembly of Clause 18, wherein the multi-dose inhaler comprises an indicator for indicating doses of medication remaining in the inhaler.
Clause 20: The assembly of Clause 18 or Clause 19, wherein the inhaler comprises air vents and wherein the inhaler port of the adapter covers the air vents when the inhaler is connected to the inhaler port.
Clause 21: A method of providing aerosolized medication to a patient through a patient ventilation assembly, comprising: attaching an inline adapter between an inspiratory port of a patient wye and an inspiratory limb of a ventilation assembly comprising tubing configured to be connected to a ventilator, wherein the adapter comprises: an elongated hollow body comprising an open first end configured to be connected to the inspiratory port of the patient wye, an open second end opposite the first end, and a sidewall extending therebetween defining an airflow channel; an inhaler port extending from the open second end of the adapter body configured to be connected to an inhaler; and an inspiratory branch comprising an open first end extending from an opening in the sidewall of the adapter body and an open second end configured to be connected to the inspiratory limb of the ventilation assembly, wherein a longitudinal central axis of the inspiratory branch is angled relative to a longitudinal central axis of the adapter body; connecting the inhaler to the inhaler port of the adapter; actuating the ventilator to provide breathing air to the patient through the ventilation assembly and adapter; and actuating a dose release actuator of the inhaler to provide aerosolized medication to the patient through the adapter and ventilation assembly.
These and other features and characteristics of the present disclosure, as well as the methods of operation and functions of the related elements of structures and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limit of the invention.
Further features and other examples and advantages will become apparent from the following detailed description made with reference to the drawings in which:
As used herein, the singular form of “a”, “an”, and “the” include plural referents unless the context clearly states otherwise.
As used herein, the terms “right”, “left”, “top”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. The term “proximal” refers to the portion of a medical device or assembly which is closest to and/or in contact with the patient. The term “distal” refers to the opposite end of the medical device or assembly from the proximal end. Thus, the term “distal” refers to a portion of a medical device or assembly which is farthest away from the patient. However, it is to be understood that the invention can assume various alternative orientations and, accordingly, such terms are not to be considered as limiting. Also, it is to be understood that the invention can assume various alternative variations and stage sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are examples. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
Unless otherwise indicated, all numbers expressing quantities of ingredients, reaction conditions, dimensions, physical characteristics, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by the present invention.
Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
Also, it should be understood that any numerical range recited herein is intended to include all sub-ranges subsumed therein. For example, a range of “1 to 10” is intended to include any and all sub-ranges between and including the recited minimum value of 1 and the recited maximum value of 10. That is, all subranges beginning with a minimum value equal to or greater than 1 and ending with a maximum value equal to or less than 10, and all subranges in between, e.g., 1 to 6.3, or 5.5 to 10, or 2.7 to 6.1.
As used herein, “aerosol” means a colloid of fine solid particles or liquid droplets, such as for example particles or droplets of a drug, medication or medicament, in air or another gas.
According to an example of the disclosure, an inline adapter 110 for a patient ventilation system or line, breathing tube, or patient ventilation assembly 200 is disclosed herein. The inline adapter 110 allows a user to mount or connect an inhaler 250, such as a metered dose inhaler, to the ventilation line or breathing tube, such that a dose of medication dispensed by the inhaler 250 can be delivered to a patient through the breathing tube. The medication to be delivered to the patient can be any aerosolizable medication, such as, for example, an aerosolized mixture of ipratropium bromide and albuterol.
As shown in
The adapter 110 of the present disclosure can facilitate delivery of the dose of dispensed medication which is delivered to the patient. In order to facilitate medication distribution, in some configurations, the longitudinal central axis Y1 of the inhaler is coextensive with a longitudinal central axis X2 of the adapter, as shown in
In some examples, as shown in
Inline Aerosol Adapter
An exemplary adapter 110 configured to be connected to a ventilation assembly 200 for providing a dose of an aerosolized medication expelled from a metered dose inhaler 250 to a patient is illustrated in
The adapter 110 can be formed from a suitable rigid plastic material such as high density polyethylene, polystyrene, polystyrene-butadiene, and/or a polycarbonate material. In some examples, the adapter body 112 can be substantially clear or transparent so that a user can see the aerosolized medication dispersed from the inhaler mounted to the adapter 110 travel through the adapter 110 and enter the patient wye 218. By looking through the substantially clear or transparent sidewall of the adapter 110, a user can also confirm that different portions of the patent ventilation assembly 200 are correctly connected to the adapter 110. For example, a user can visually confirm that an inspiratory port 226 of a patient wye 218 is inserted into the adapter 110 an appropriate amount to form a suitable seal therebetween. Generally, the thickness 119 of the sidewall 118 of the adapter 110 can range from about 0.04 inches to about 0.08 inches, or about 1.0 mm to about 2.0 mm, or any size desired. The thickness of the sidewall can be uniform or tapered. For example, as shown in
The adapter 110 can be manufactured using various plastic manufacturing techniques as are known in the art. For example, the entire adapter 110 can be formed by a single-shot injection molding process in which the main body and angled tube are manufactured simultaneously in the same mold. In other examples, different portions of the adapter may be molded separately and connected together by, for example, an adhesive or plastic welding technique. In other examples, the adapter 110 can be manufactured by a two-shot injection molding process.
As shown in
As shown in
The adapter 110 further comprises an elongated, tubular inspiratory branch 124 comprising an open first end 126 extending from an opening 130 (shown in
In some examples, a length of a longest longitudinal side L3 (shown in
In some examples, the inspiratory branch 124 extends from the adapter body 112 in a sloped or angled configuration. For example, a longitudinal central axis X1 (shown in
The inhaler port 122 is adapted to receive a medication inhaler 250 configured to deliver metered doses of aerosolized fluid containing a medicinal agent. For example, the inhaler 250 can be a single-use or multi-use inhaler for delivering a mixture of ipratropium bromide and albuterol (e.g., a Combivent® Respimat® inhaler having a cartridge affixed thereto). The inhaler port 122 generally comprises an elongated sidewall 134 (shown in
In some examples, the peripheral wall of the mouthpiece 252 of the inhaler 250 is inserted into a receiver defined by the sidewall 134 of the inhaler port 122. In order to receive the mouthpiece 252 of the inhaler 250, the inhaler port 122 can have any cross-sectional shape, such as a circular or elliptical cross section, which corresponds in size and shape to the exterior of the open end of the mouthpiece 252 of the inhaler 250. In some examples, the cross section of an elliptical opening has a major internal diameter D9 which can range from about 0.5 inches to about 1.25 inches and, for example, may be between about 0.8 inches and about 1 inch, or any size desired. In some examples, the cross section of an elliptical opening has a minor internal diameter D10 which can range from 0.3 to about 1.25 inches and, for example, may be between about 0.5 inches and about 0.75 inches or about 0.6 inches, or any size desired. In some examples, the cross section of a circular opening (not shown) has an internal diameter D11 which can range from about 0.3 inches to about 1.5 inches and, for example, may be between about 0.5 inches and about 1 inch, or any size desired. The sidewall 134 thickness of the inhaler port 122 can be about 0.03 inches to about 0.07 inches, or any size desired. The sidewall 134 can be configured to cover air vents, if present, on a discharge port of the inhaler, so that as much of the dispensed dose as possible is directed into the channel 120 of the adapter 110. The sidewall 134 can comprise one or more notches 135 to accommodate the inhaler. The depth of the notch 137 can range from about 0.1 to about 0.5 inches, or any size desired. The width 139 of the notch can range from about 0.25 to about 0.75 inches, or any size desired.
The inhaler port 122 further comprises an interior wall 136 (shown in
In some examples, the interior wall 136 further comprises a distally extending protrusion 140 extending about the opening 138. The protrusion 140 (shown in
In some examples, the adapter 110 further comprises a cap 150 (shown in
The cap 150 can be formed from a variety of materials including, for example, plastics, rubbers, or metals. In some examples, the cap 150 is formed from a flexible thermoplastic rubber material, such as a thermoplastic polyurethane, olefins, or silicone. The thermoplastic rubber is capable of releasably adhering to the sidewall 134 of the inhaler port 122 to form a secure connection therewith. In some examples, the cap 150 further comprises a tether 156 having a first end 158 connected to the cap 150 and a second end 160 connected to the adapter body 112. For example, the second end 160 of the tether 156 may comprise a loop 162 configured to receive a corresponding protrusion 164 extending from the adapter body 112, such that the cap 150 is rotatably secured to the adapter body 112 through the tether 156. As a result of the tether 156, a user can merely let go of the cap 150 after it is removed from the inhaler port 122. The cap 150 then hangs freely from the adapter body 112 as the inhaler is being used to provide medication to the patient, as shown in
Patient Ventilation Assembly and Breathing Circuit
According to an example of the disclosure, a patient ventilation assembly 200 or breathing tube is provided. As shown in
As shown in
As in previously described examples, the adapter 110 shown in
As shown in
In some examples, the arrangement of the medical tubing (inspiratory limb 220 and expiratory limb 222), patient wye 218, and inline adapter 110 is selected to permit easy set-up and storage of ventilation assembly components. In addition, the medical tubing is arranged to avoid forming kinks in the tubing and so that the tubing does not interfere with other devices being used to provide care to the patient. For example, as shown in
In some examples, as shown in
Method for Delivering a Dose to a Patient
Referring now to
The method comprises attaching an inline adapter 110 between an inspiratory port 226 of a patient wye 218 and an inspiratory limb 220 connected to a ventilator 310 (shown in
Once the adapter 110 and medical tubing of the ventilation assembly 200 are assembled and, when ready to provide a dose of medication to the patient, the user may prepare an inhaler 250 for use in a conventional manner. For example, the user may remove a cap or packaging from the inhaler 250. The user may prime the inhaler 250 by rotating the primer, or holding the inhaler in an upright position (e.g., with a mouthpiece 252 of the inhaler pointing upwards) and pressing a drug release button 254 or another prime button in accordance with instructions provided by the manufacturer of the inhaler 250. Once the inhaler 250 is primed and ready for use, the user removes the cap 150 from the inhaler port of the adapter 110 by, for example, holding the adapter body 112 in one hand, grasping the cap 150 in the other hand, and pulling the cap away from the adapter body 112 so that the annular sidewall 152 of the cap 150 slides away from the sidewall 134 of the inhaler port 122, in the direction of arrow A1 (shown in
Once the inhaler 250 is connected to the inhaler port 122, as shown in
Pressing the dose release button 254 causes the inhaler 250 to release an aerosolized dose of the medication through a discharge port 264. The released dose is directed to the airflow channel 120 of the adapter body 112 as shown in
As shown in
Once all of the prescribed doses of the medication have been delivered from the inhaler 250 to the patient or the medication is no longer needed, the user may remove the inhaler 250 from the inhaler port 122 by grasping the inhaler 250 and pulling it away from the inhaler port 122 in the direction of arrow A3 (shown in
In order to demonstrate that the adapter disclosed herein delivers medication to a patient in appropriate quantities, the following experimental test was performed. A Combivent® Respimat® metered dose inhaler and cartridge were mounted to the adapter. Medication was discharged from the inhaler and an amount of aerosolized fluid which passed through the adapter was collected. The inhaler was used with three sample adapters to account for possible differences in manufacturing. Three tests were performed per adapter sample for a total of nine measurements per medication and output variable. Results from the nine tests were either averaged or provided as a range. The test results for an example of the presently disclosed adapter shown in
195% confidence intervals.
There is an unmet need in the art for an inline adaptor to deliver medicament in a straight line through the adapter from a Combivent® Respimat® type of metered dose inhaler and cartridge to a breathing circuit. As shown by the experimental results, the tested example of the presently disclosed adapter successfully provides an average of about 72.2% of the dosage of albuterol and about 66% of the dosage of Ipratropium Bromide normally delivered from a Combivent® Respimat® metered dose inhaler and cartridge without use of an adapter.
The preceding examples and embodiments of the invention have been described with reference to various examples. Modifications and alterations will occur to others upon reading and understanding the foregoing examples. Accordingly, the foregoing examples are not to be construed as limiting the disclosure.
The present application claims priority from U.S. Provisional Patent Application No. 62/476,609, filed on Mar. 24, 2017, which is incorporated herein by reference in its entirety.
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Number | Date | Country | |
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20180272084 A1 | Sep 2018 | US |
Number | Date | Country | |
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62476609 | Mar 2017 | US |