Note: Descriptions are shown in the official language in which they were submitted.
~ CA 02207219 1997-06-19
Application for Patent under rule 93
SUBJECT: Spacer Device and method of its use
INVENTOR: Leszek Mankowski
ABSTRACT:
An auxiliary spacer device for use with metered dose aerosol devices shown in various
embo-1iment~. For use in hospital and home settings~ as well as ambulatory use. It
incorporates several unique features that ej~njfic~nt1y improve the th~La~euLic effects of
m~?~ic~tions atlminietered in metered dose aerosol form, allows for cor~nection with other
standard m~ 1 devices for u~ Lell ~led tre~tm~nt of both adults and children, including
i~fants. The device is user friendly and inexpensive to produce.
BRIEF DESCRIPTION OF DR~WlNGS:
Figure l:
Shows a spacer device in its pl~r~ d embodiment for use in hospital and home settings,
shape and size of elemPnt.e in approximate size and proportions, allowing for connection
with standard mPf~ devices, e.g.: m~lsk, oxygen tubing with collection bag, nebulizer,
Ventury valve or even between intub~ti-)n tube and a respirator. It is shown in
lon3~it~1in~1 cut through a central portion and drawn in approximately l: l scale, giving it
total volume of about 600 cc. Description of its el~ ?nte will follow.
Figure 2:
Shows the off-center longitu~lin~1 cut ofthe back portion ofthe spacer device showing the
aerosol container l l ~ttsl~he~l to its unique nozz1e 13, "snapped" into its "sparrow-shaped
nest" basket 12. The holding arms are not visible in this projection.
Figure 3:
Shows back portion ofthe spacer device viewed from behind with two aerosol cont~iners
11 of same or dilr~Lelll medications "snapped" into position. Holding arms as well as
nozzles are visible. The round object located between the nozzles is an inlet port with
inlet valve in place.
Figure 4:
Shows back portion of spacer device with two aerosol containers viewed from the top. It
illustrates the shape ofthe holding arms, central 9 and lateral 14, ialet port l0.
Figure 5:
Shows details of inlet valve l l, valve ~ e 17 and its holding hooks 18.
Figure 6:
Shows the front part ofthe spacer device in plc;r~ llc;d embodiment form for hospital and
home use. It comprises of a "snap on" mout_ piece l, that "sits" on the neck portion of
the spacer device. In its mid-portion the mouth piece l shows outlet orifices 3 that are
covered by "rubber-band-like" circular ~ lllI)r~e 2 that acts as an outlet valve p~vellL~g
T ~ CA 02207219 1997-06-19
air from entering the mouth piece from outside during hls~ildLion. During expiration it is
stretched by the force ofthe expired air allowing it to escape through the outlet orifices 3.
It also senes one more unique and important function by providing air flow resistance,
causing the patient to exh~le against resistance that is provided through the stretch of the
"rubber band" 2, and thus pr~/~llillg the "collapse" of bronchial tubes and secondary
l of exhaled air within the bronchial tree. A patient in an ~cthm~tic attack
inctin(~tively does the same by pouching his mouth to create a small opening for expiration
and slowly expires the air. The neck portion of the spacer device, b~w~ll the mouth
piece I and the body 8 is occupied by another unique element that works like a turbine. It
consists of a central shaft 6 with tapered ends to which are attached t~ree fins spaced
equally along shaft 6 ciL~ el~ce and are twisfed along its long axis. Both the fins 5
and the shaft 6 are stationary and are attached to the front of the neck of the spacer
device. On the front portion ofthe turbine sits a dome s~aped valve 4 that has a central
opening and is attached to the periphery between the mouth piece I and the neck. To the
rear portion of the shaft is ~tf~h~d a screen which catches larger droplets of aerosol
mixture passing through it. The function ofthe turbine is to increase the speed and cause
a twisting of the aerosol/gas mixture into a narrow vortex-like stream promoting deep
penekation ofthe mt?/1ic~tion into the bronchial tree where it is needed. No other spacer
device has this feature and all produce a wide and turbulent stream. The body 8 occupies
the largest portion of the spacer with volumes between as little as 100 cc to 600 cc that
can be fixed or adjustable pending patient size, mP~ ti-)n or method of treatment by a
"collapse" mecl~ shown in figure 9. It would then also have m~rkin~ int1i~ tin~
volume in (]ia~;ltll~ "collapsed" positions with name of_edication best suited with the set
volume. It is to be made, prer~ldbly, out of clear plastic or acrylic but other m~tçri~l~ may
be used. Also various labels or designs with popular characters may be incorporated to
make it more attractive and less intimi~1~ting to teenagers and younger children, thus
promoting its use.
Figure 7:
Shows the valve in ~lert;rled spacer embodiment, for hospital/home/portable use. It is
dome shaped with a central orifice and marginal sk~t, made from stretchable m~teri~l
e.g.: rubber, latex.
Figure 8:
Shows secondary embodiment of the outlet valve 4 made of rigid plastic/acrylic m~tPri~
that is also dome shaped with central opening, that has a rim that extends upward as
shown in (a) or dowllw~,ds (b). Both versions ofthis valve are not attached and move
freelywithin the mouthpiece 1. The function ofthe rhn is to close the outlet ports 3
during hL~ildlion and open them during expiration.
Figure 9:
Shows a p~ led embodiment of a spacer device for portable use in "collapsible" form
and diJ~ elll design of the mouthpiece 1 (a) that also incorporates its closing mech~ni~m,
col~si~ g oftip portion 15 that slides along the horizontal axis ofthe mouth piece and
when in asymmPtrir~l position closes the outlet ofthe mouth piece. The total volume of
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the spacer body 8 (b) in fully expsln~le~l position is about 250 cc. The rest of the elementx
are similar to the prt;r~lled embodiment in hospital/home version, Fig. 1. The resemblance
to a water bottle or pop container is not coincidental. It is intçn~1ed to alleviate possible
m~-nt by some patients and thus promote its use.
Figure 10:
Shows the pr~r~lled embodiment ofthe spacer device for portable use in fully collapsed
form.
Figure 11:
Shows a rubber or plastic cover with central two orifices to accommodate the tips of the
aerosol cont~inf~rx, it is to be "snapped on" the back portion ofthe spacer device shown in
Fig. 10, to protect the aerosol containers from accidental disengagement from the spacer
device and conceal its use further imitz~ting a non-medical device.
Figure 12:
Shows fcont portion ofthe spacer device in the pl~r~ d embodiment for the
hospitallhome use during the inspiratory phase.
Figure 13:
Shows front portion ofthe spacer device in the prert;l~ed embodiment for the
hospitallhome use during the expiratory phase.
Figure 14/15/16/17:
Shows di~ l embodiment of the back portion of spacer device where the aerosol
co..~ , x are attached to one body with two nozzles and settled within the body ofthe
spacerdevice. Alsoshownarethedi~ positionsofaerosolcontainers. Ring19
attaches to the base with two nozzles and is int~n-led to ease its removal from spacer
device, it also serves for positioning ofthe right/left finger ofthe patient holding the
device.
HOW DOES THE DEVICE WORK?
During the ~hm~ti~ attack or exacerbation of asthma the patient seals his lips around the
spacer device mouthpiece and breathes continuously in and out from and into the device.
One or mllltirle doses of m~ic~tions are a~lminixtered from aerosol canisters usually
Ventolin and Atrovent (trade names). Dependent on ci~ lal.ees oxygen tubing with a
collection bag is att~cht?d to the inlet port 10 or tubing with the mixture of oxygen and air
provided by the Ventury device. This mixture of medications and oxygen from the body
ofthe spacer device is rushed through the turbine device and the valve for which opens
allowing the mixture to pass through it and into the patient's bronchial system, as shown
inFig.12. Withthelipsof thepatientre...~;..;..gsealedaroundthemouthpiece l,patient
e~h~les. This causes the valve 4 to close and rubber-band-like valve 2 to open, allowing
the exhaled air to escape through the ports 3 as shown in Fig. 13. This process continues
until clinical improvement is achieved. In between the a.1".;.,ixl ~lion ofthe m~ atiQn,
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the patient continues to inhale and exhale through the spacer device. Depending on
ci~ ces, inhsll~ti~n can be continually supported by 100% oxygen with ~tt~-ht?d
bag, hllmi~lified oxygen or mixture of oxygen and air provided by Ventury device through
the inlet port 10. Iffor any reason the patient cannot hold the spacer device, it can be
z~tt~ch~d to the mask by the mollthpiece. The portable pler~ lled embodiment works on
similar basis, with the difference that the valve 4 has a dual function opening and closing
both orifice 20 (Fig.12) and outlet 3 consecutively during the respiratory phases.
