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Based on the Medicator®
Aerosol Maximizer
high-efficiency aerosol drug delivery system and nebulizer,
with Möbius™
aerosol and medical gas delivery technology, the Asthma
Rescue Kit™ is an aerosol delivery system that seamlessly
transitions between all modalities of aerosol therapy for
the severe asthmatic:
The Asthma Rescue Kit is based on a simple, classic principle that really makes sense:
a new paradigm: low-flow, closed-system We have intentionally created a new paradigm. The Asthma Rescue Kit is a low-flow, quasi-closed system device with integral exhalation filtration. It utilizes a portless mask, an elastic rubber reservoir bag, and is designed to conserve, rather than waste, both aerosol and breathing gas. Maximum gas flowrate into the device is only 8 L/min. Higher flowrates do not result in greater effectiveness and will only waste both aerosol and heliox. In fact, too much flow will cause the device to become less effective as an aerosol delivery device because the reservoir bag will not get an opportunity to work properly (it must alternately fill and empty; staying filled does not enhance aerosol delivery). It is for this reason that we use a non-latex elastic rubber reservoir bag instead of a more-attractive looking vinyl bag. A vinyl bag simply does not work as well because it has no elasticity and tends to remain inflated. Remember, it is the emptying of the bag during the patient's inspiratory phase that helps to enhance aerosol delivery by providing the patient with aerosol that was stored in the bag during the previous exhalation phase.
The Asthma Rescue Kit is designed for the emergency care needs of the asthmatic patient who presents to the Emergency Department during an acute exacerbation. The Asthma Rescue Kit can be quickly removed from its storage bag and attached to a wall-mounted oxygen flowmeter. The 90 mL nebulizer can be loaded with one, two or three unit dose vials of beta agonist medication to instantly start aerosol therapy with oxygen. At this point the practitioner can bring a heliox cylinder to the bedside and plug it into the Asthma Rescue Kit to begin heliox therapy. Thereafter, medication for continuous beta agonist aerosol therapy can be prepared and added to the 90 mL nebulizer for approximately 4 - 6 hours of continuous beta agonist aerosol therapy. Alternately, the device may be directly attached to a flowmeter on an 80/20 heliox cylinder, if it is readily available, and therapy with heliox may be immediately started.
Original Medicator Device. The Asthma Rescue Kit is based upon the design and function of the original patented Healthline Medicator Aerosol Maximizer high-efficiency aerosol drug delivery system:
The original Medicator Aerosol Maximizer is a hand-held device for administered aerosolized medication treatments. It functions as a nebulizer enhancement device by virtue of the reservoir bag and the flow-control diaphragm (flapper valve). When the patient, as represented by the mouthpiece, exhales into the system, exhalation gas exits to atmosphere through the exhalation filter. Meanwhile, the flapper valve is held closed by the exhalation pressure at the beginning of the exhalation phase. During the exhalation phase, the nebulizer, which is operating continuously, fills the reservoir bag with a bolus of aerosolized medication. Practically no aerosol, true to its characteristic of being able to remain suspended in a gas stream, is lost to the walls of the reservoir bag. On the subsequent breath, as the patient begins the next inhalation phase, the flapper valve opens wide and the aerosol that had been stored in the bag during the previous exhalation phase is directed toward the patient by the elastic recoil of the expanded reservoir bag. The aerosol that has been stored in the bag is inhaled by the patient along with the aerosol that the nebulizer is instantaneously creating. The original Medicator Maximizer high-efficiency aerosol delivery device has been described in the peer-reviewed literature by numerous authors:
Medicator Möbius Device. The Medicator Möbius device is essentially a Medicator Aerosol Maximizer that has been modified by the simple addition of the "Mix and Mount" Cap for mounting the device on a wall oxygen flowmeter, capping of the normal exhalation port on the body of the Medicator manifold, and the addition of a larger volume nebulizer. When a patient interface consisting of a 6 foot aerosol tubing. Aerosol Delivery Tee, a Portless Mask and an Expiratory Filter is added, the entire assembly comprises the principle components of the Asthma Rescue Kit.
The Portless Mask is connected to the short limb of the Aerosol Delivery Tee. The long limb of the Aerosol Delivery Tee is attached to a 6-foot extendable corrugated aerosol tubing which, in turn, is connected to the outlet Port of the Möbius device. An Expiratory Filter is connected to the side port on the Aerosol Delivery Tee. The Möbius device and the 6-foot tubing, Aerosol Delivery Tee, Portless Mask and Expiratory Filter, plus any included accessories such as a mouthpiece and/or disposable peak flow meter, comprise the complete Asthma Rescue Kit. It should be noted that the flapper valve in the Möbius device has a maximum surface area of nearly 1 square inch and, unlike typical center-post or 4-leaf respiratory valves, it opens cleanly to reveal an unobstructed pathway for aerosol. As such, it is not a barrier to aerosol pass-through. Due to the low operating flowrate of this device, and especially the reduction of turbulence when used with heliox, there is practically no rainout of aerosol in the 6 foot delivery tubing. Further, there are intentionally no other valves to hinder aerosol delivery in the pathway between the device and the patient interface. Schematic Diagram of the Möbius Device.
The "Mix and Mount" cap is a hollow plastic part that contains 3 inlet ports and 1 outlet port. It has only 5 surfaces: a top plus 4 sides; there is no bottom surface. The bottom edge of the Mix and Mount Cap is ultrasonically welded to the top of the Medicator Body to strongly bond it to the body to serve as a convenient flowmeter mounting point and to allow mixing of oxygen and heliox, if desired, for powering the nebulizer. The inside of the Mix and Mount Cap does not communicate directly with the Medicator Body. Instead, the gas from the Mix and Mount Cap exits through the "Power Outlet to Nebulizer" Port where it is directed to the nebulizer inlet through a short length of tubing. One of the three inlet ports is a standard DISS 1240 threaded female oxygen inlet, while the other 2 inlet ports are 3/16" diameter non-barbed hose connectors (nipples). All three inlet ports have a check valve located on the inside of the "Mix and Mount" Cap in order to effectively block backflow or leakage from any port that is not connected during operation. This makes it possible to accommodate any of the following gas connection scenarios:
Power Outlet to Nebulizer. The Power Outlet to Nebulizer port is the only exit pathway for gas to leave the Mix and Mount Cap. The device comes preassembled with a piece of small bore vinyl tubing, with typical oxygen tubing cuffs on each end, connected between the Power Outlet to Nebulizer port and the inlet connector on the bottom of the nebulizer (Neb 90). Pole Mount Socket. A socket on the bottom of the Medicator body allows the device to be optionally mounted on a Pole Mount Bracket that can be attached to a IV pole. This alternative mounting arrangement will maintain the device in the proper horizontal position without having to attach it to a wall oxygen flowmeter if one is not available. When operated on a pole mount bracket, oxygen and heliox can be connected to the device through the Auxiliary Gas Inlet Nipples on the Mix and Mount Cap. Medication Port Plug. A removable gray stopper is situated on the top of the Medicator body, directly in line with the vertical axis of the nebulizer, and behind the Mix and Mount Cap. This stopper will function as an injection port so that a needle can be inserted through it to introduce medication into the nebulizer. Alternately, the stopper may be removed and medication added through a "needleless" administration system or poured in from a unit dose plastic ampoule. Neb 90 Large Volume Medication Nebulizer.
The Neb 90 is a modification of one of our existing small particle
nebulizers, the Neb 3A. The principle modification involved
making the medication cup and internal pickup tubes longer so that a
capacity of around 90 mL could be achieved.
Internal baffling was adjusted to render a particle size of ~ 1.0 to
1.5 µm.
Particle size of saline or albuterol solution is ~ 1.5
µm (MMAD) when the nebulizer is driven
with 100% oxygen and ~ 1.0 µm (MMAD) when driven with 80/20 heliox.
See complete
performance specifications below. 1. Remove the Medicator Möbius™ device from its zip lock plastic bag and attach it to an oxygen flowmeter by screwing the green DISS O2 mounting nut onto the flowmeter outlet. Retain bag for accessories. Alternately, the Möbius™ device may be pole mounted by inserting the pole mount socket on the body of the device onto a Cat. No. PM-808 Pole Mount Bracket or an Asthma Rescue Kart™. If pole mounted, attach one end of an oxygen tubing to the flowmeter on an O2 source and attach the other end to either of the Auxiliary Gas Inlet Nipples on top of the “Mix & Mount” cap. One-way check valves in the “Mix & Mount” cap will keep gas from leaking through any unused ports.
2.
Add the prescribed medication to the Neb 90
by either: (a) injecting medication with a syringe
and needle through the gray rubber Medication Port
Plug, or (b) temporarily removing the Medication
Port Plug and squirting the medication into Neb 90
from a plastic unit dose ampoule, or (c) removing
Neb 90 from the Möbius™ body and adding medication
directly into the cup.
The Neb 90 nebulizer will operate briefly
with as little as a 3 mL unit dose, or continuously
with as much as 90 mL.
For continuous nebulization, a 90 mL fill
volume will last approximately 4 hours or more
depending on gas composition (see table).
3.
If operating with 100% O2, set O2
flowmeter at 8 L/minute.
If operating with heliox, attach tubing from
a calibrated heliox flowmeter to either of the
Auxiliary Gas Inlet nipples on top of the Möbius™
“Mix & Mount” cap. Set O2 + heliox flowrates
to equal 8 L/minute when summed, according to the
Gas Mixing Table below.
4.
Extend the extensible aerosol tubing to
required length (up to 6 feet) to reach the
patient and fit the portless mask to the
patient, taking care to ensure a good seal
with no leaks.
Observe the “flapper” valve inside
the Möbius™ body for proper operation in
sync with the patient’s breathing.
If the flapper valve stays open, the
mask seal is probably inadequate and the
leak should be corrected for proper
operation.
5.
Observe and monitor patient
frequently, maintain total flowrate
of 8 L/minute and make periodic spot
check measurements of FIO2 through
the O2 Sensor Port for confirmation.
A Peak Flow Meter is included
with some versions of the Asthma
Rescue Kit™.
The mask may be replaced with
the included mouthpiece if the
patient’s condition warrants therapy
by mouthpiece.
1.
A 3 mL unit dose of
medication will be nebulized
in approximately 3 minutes
or less. Thereafter
the patient will receive dry
gas unless the nebulizer is
refilled promptly or set up
for continuous nebulization.
If you wish to begin initial
therapy with unit dose
medication, while the
appropriate amount of
continuous medication is
being prepared, placed two
or three complete unit dose
ampoules into the nebulizer
(6 - 9 mL).
2. Do not operate at less than 8 L/minute total flow. Operation at less than 8 L/min total flow, especially with heliox, will adversely influence aerosol generation by the nebulizer and may result in insufficient flow to meet patient inspiratory demands. 3. Do
not operate at greater than
10 L/minute total flow.
While operation at greater
than 8 L/min should not
ordinarily be necessary, the
device may be operated at a
slightly higher flowrate if
desired (e.g. 10 L/min).
If you operate the device at
higher than 8 L/minute, the
supplied Gas Mixing Table
will not be relevant.
Therefore, you must
determine inspired gas
concentrations by
analysis. 6. Maintain device in a level position (nebulizer perpendicular to the floor) at all time to prevent spillage and allow proper operation of the "flapper" valve. [ performance specifications ]
1 Caution: FIHe < 0.60 - 0.50 is probably not clinically effective Aerosol Generation Rate. The nominal Aerosol Generation Rate (AGR) (output) of the Neb 90 for normal saline or albuterol solution has been determined by averaging the gravimetric analysis of 6 random samples of Neb 90. 100% Oxygen. Mean AGR is 0.344 (±0.009 SD) mL/minute or 20.64 (±0.533 SD) mL/hour when the nebulizer is powered by 100% oxygen at 8 L/minute. The coefficient of variation (CV) of these measurements (n=6) was 3%. 80/20 Heliox. Mean AGR is 0.195 (±0.019 SD) mL/minute or 11.7 (±1.112 SD) mL/hour when the nebulizer is powered by 80/20 heliox (80% helium/20% oxygen) at 8 L/minute. The CV of these measurements (n=6) was 10%. This relationship is expressed on the graph below:
The Aerosol Delivery Rate for 100% oxygen (green line) and 80/20 heliox (brown line) is shown graphically for 4 hours. Other gas concentrations (i.e., 70/30, 60/40, and 50/50 heliox) would fall between these two lines. The error bars on the data points represent the CV for each set of gas measurements, i.e., ±3% for oxygen and ±10% for 80/20 heliox. [ medication preparation & nebulization rate ] Continuous nebulization for 4+ hours can be achieved by filling the nebulizer with 80 mL of 0.5% medication (5 mg/mL) diluted with 0.9% sodium chloride (normal saline) solution. The chart below shows the standard medication preparation and nebulization rates for two different driving gases (100% oxygen and 80/20 heliox) at a fill volume of 80 mL. Remember, the Aerosol Generation Rate (AGR) is ~ 20 mL/hour with 100% oxygen and ~ 12 mL/hour with 80/20 heliox, representing the "best case" and "worst case" nebulization rates, respectively. The nebulization rates for other gas mixtures (e.g., 70/30, 60/40 and 50/50 helium/oxygen) will fall in between these two extremes. Medication Preparation & Nebulization Rate Chart for 80 mL Nebulizer Fill Volume:
The nebulization rate is expressed graphically below ...
If using 100% oxygen, attach the device to a reliable oxygen flowmeter at a setting of 8 L/min. If heliox is desired, heliox may be introduced into the device through either of the two Auxiliary Gas Inlet Nipples on the Mix and Mount Cap. Even when mixing oxygen and heliox, care must be taken to ensure that the total flow to the nebulizer is 8 L/min. The following gas mixing chart shows the heliox and oxygen concentration that results from mixing different ratios of 100% oxygen and 80/20 heliox (80% helium/20% oxygen) at a total flow of 8 L/minute:
Note: Accurate flowmeters for both oxygen and heliox are essential if the delivered gas concentrations are to closely approximate the predicted values from this chart. As noted above, you may measure FIO2 with a portable oxygen analyzer sensor inserted into the measuring port on the body of the Medicator Möbius device. Inspired helium concentration may be predicted by subtracting the oxygen concentration from 100%. [ heliox regulators & flowmeters ] Healthline recommends that a reliable regulator/flowmeter combination, specifically calibrated for 80/20 heliox, be used in conjunction with the Asthma Rescue Kit. The Asthma Rescue Kit only requires a heliox flowrate of 5, 6, 7 or 8 L/minute in order to provide delivered heliox concentration of 50%, 60%, 70% and 80% respectively. While it is possible to use an oxygen flowmeter, and apply correction factors for determining actual heliox flowrate, that method does not have the precision necessary to accurately achieve discrete flowrates of heliox in 1 L/minute increments, as required by the Asthma Rescue Kit. We have used both brands of the heliox regulator/flowmeters listed below and provide this reference to them in order to offer broader choices to users of the Asthma Rescue Kit. The regulator/flowmeter from Genstar Technologies is a traditional type of diaphragm-based regulator with a back-pressure calibrated Thorpe tube flowmeter, specifically calibrated for an 80/20 heliox mixture. The chief advantages to this design are established user familiarity, low cost, and ability to confirm that it is operating by observing the ball suspended in the float tube. The regulator/flowmeter from Flotec is a newer design known as a single stage, piston type, backpressure compensated, pressure reducing cartridge with an internal relief valve. The “click style” flowmeter module offers up to 12 flow settings but, the device that is depicted here has only the flow settings required for the Asthma Rescue Kit. The chief advantages to this design are simplicity, accuracy, ruggedness, durability and ability to be used in any position. We urge you to contact both manufacturers for information and pricing and to determine the best choice for your overall needs.
[ cylinder duration & gas consumption ]
The following chart contrasts the low heliox consumption of the Asthma Rescue Kit with the much higher consumption of two brands of large volume medication nebulizer with secondary gas ports. It can first be noted that the Asthma Rescue Kit is capable of a wide range of FIHe where the other devices can not deliver an FIHe of 80% because the nebulizer jet is being powered by a primary gas flow of 100% oxygen. Second, with the Asthma Rescue Kit, a cylinder of heliox may only have to be changed once per shift, or possibly not at all, compared with potentially many times per shift for the high flow competing devices.
The calculations on this chart can be easily reproduced by plugging the requisite values into the standard gas mixing equation:
The Asthma Rescue Kart™ is the answer to the frustrating problem
many Respiratory Care Departments face with regard to storing and
deploying heliox cylinders quickly in an emergency. With the
Asthma Rescue Kart™, two heliox cylinders can be kept on the ready
on the Kart. One cylinder can be immediately used while the
other is on standby. When it is time to change cylinders, you
can quickly switch to the standby cylinder and then change the empty
at your leisure. In addition, the pole mount bracket, work
surface and storage compartments provide plenty of space for Asthma
Rescue Kits™, oxygen analyzer, medications and recording keeping.
Download Asthma Rescue Kart™ Sales Flyer (2.1 Mb PDF)
Packaging & Shipping. The Asthma Rescue Kit is packaged
for single-patient use in a sealed see-through zip-lock plastic bag with a
convenient hang hole in one corner. Each bag is provided with
a tamper-evident seal placed across the zip lock. The Asthma Rescue Kit is
shipped in boxes of 5. The dimensions of a box of 5 Asthma
Rescue Kits is 10 x 10 x 12 inches.
"Adult" denotes the adult-sized portless mask; "Pediatric" denotes the child-sized portless mask.
Where to Order. The Asthma Rescue Kit is
manufactured by Healthline Medical and is available for
purchase through a number of routes. Healthline Medical sells
direct and will accept telephone orders called in Monday through
Friday, 8:00 am until 4:30 pm Pacific Time. You may also call
the toll-free number to request to have a salesperson contact you.
Healthline also recommends contacting the experts at LifeGas for a readily available source of 80/20 heliox in a variety of cylinder sizes. [ inservice educational materials ] PowerPoints and Technical Bulletins. The documents listed below may be freely downloaded for Respiratory Care and Emergency Departments to use for staff training and continuing education. Commercial use is not allowed. Right click on a link, then select "Save Target
As ..." in order to download the PDF file. Left click on the
link to open the file in your browser's Adobe Acrobat Reader
plug-in or PowerPoint Program. Some of these files are
quite large and may take a while to completely download.
•
Technical Bulletin - Is There Exhaled CO2 Rebreathing with the
Asthma Rescue Kit? (.pdf) Technical questions concerning the Asthma Rescue Kit can be directed to info@aerosol-medicine.com.
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Under construction; check back later.