Note: Descriptions are shown in the official language in which they were submitted.
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AIRLESS INTRAVENOUS BAG
FIELD OF THE INVENTION
[0001] The present invention relates to the field of intravenous bag systems,
and more
particularly, to an airless intravenous bag system that eliminates the need
for priming the
intravenous line when exchanging intravenous bags.
BACKGROUND
[0002] In conventional intravenous bag systems when the bags are totally
depleted (i.e.
"run dry"), the previously placed air then is allowed to leave the bag. This
usually then fills
the drip chamber and the plastic tubing of the intravenous line. This can be
problematic in
many settings.
[0003] Once the tubing has air inside of it, a new bag must be hung, the
tubing transferred
to it, and the line must be re-primed. Re-priming involves placing a syringe
and needle into a
port on the intravenous tubing and withdrawing the air from the tubing. This
takes time that
can be problematic when the patient needs intravenous medications or acute
fluid
administration for a sudden change in their vital signs (i.e. blood pressure,
heart rate, etc.). In
fact, these intravenous bags usually are not noticed "running dry" during
emergencies
because everyone's attention is usually focused on other things. During true
emergent
traumas, a patient may be getting intravenous solution more rapidly then with
the standard
gravity drip. Often times the intravenous bags are placed in pressurized bags
or machines
that literally squeeze the bag forcing the solution into the patient via the
intravenous tubing.
Unfortunately, when all the fluid is pressurized out of the bag, the entrapped
air is next forced
through the intravenous tubing, potentially into the patient.
[0004] Air in the intravenous tubing is potentially disastrous because enough
air may
cause a "vapor-lock" phenomena whereby the right ventricle of the heart fills
with air.
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Normal contractions are ineffective to push blood through the pulmonary
vasculature where it
is oxygenated and delivered to the left ventricle to be pushed out and
circulated into the body.
In other words, vapor-lock is a sudden cardiovascular collapse where no more
blood can be
circulated. An adult would need a high amount of air but a pediatric patient
with a smaller
heart would require much less air to cause this fatal scenario. Another
potential problem is
that air may not collect in the right ventricle, but may get pushed into the
pulmonary
vasculature. The name for this potentially lethal event is called pulmonary
embolism. Air
may get stuck in the pulmonary capillaries. This causes an increased
resistance to the normal
forward flow to the left atrium of blood. This increased resistance may cause
the right side of
the heart to fail, also since blood is not being circulated, the oxygen
content falls, and since it
is not getting to the left side of the heart, the output from the heart into
the body drops to
critical levels.
[0005] The above two scenarios are certainly possible but require large
amounts of air.
The most likely scenario for air entering into the vasculature and causing a
devastating
complication is via a probe patent or even an open Foramen Ovale. The Foramen
Ovale is a
unique fetal adaptation the human heart has while the fetus in the uterus.
Blood is shunted
away from the lungs (since the fetus is not breathing) and into the main
vasculature. One
way this blood is shunted past the lungs in through a hole in the septum
between the right and
left atrium of the heart. This hole is called the Foramen Ovale. Normally this
hole closes
right after birth as the human heart now directs blood into the lungs than
past them.
[0006] Unfortunately, in up to 15% of adults and a much higher corresponding
level of
neonates and children, this percentage is even higher. Probe patent means that
a probe can be
pushed through the Foramen Ovale which is only partially closed, or in other
situations, it
might be completely open. If a small air bubble makes it to the right atrium,
the normal
mechanism of passing into the right ventricle and then getting lodged into the
palmary
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vasculature is bypassed. Instead, this air bubble may pass through the Foramen
Ovale into
the left atrium (bypassing the lungs), entering into the left ventricle, and
then squeezed out
into the body. If this air bubble goes to the brain, a devastating stroke may
ensue. Central
lines, which are long catheters intravenously placed into large veins and
threaded close to the
heart are more likely to cause this situation, however, even a small
peripheral intravenous line
can still elicit this situation especially in the setting of a small pediatric
patient.
[0007] The above reasons are why medical practitioners are so adamant on not
allowing
any air to pass into the patient. Unfortunately, with the current intravenous
bags that are in
use today, this is a constant threat.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] To further clarify the above and other advantages and features of the
present
invention, a more particular description of the invention will be rendered by
reference to
specific embodiments thereof which are illustrated in the appended drawings.
It is
appreciated that these drawings depict only typical embodiments of the
invention and are
therefore not to be considered limiting of its scope. The invention will be
described and
explained with additional specificity and detail through the use of the
accompanying
drawings.
[0009] FIG. 1 is a front view of an airless intravenous bag according to one
embodiment
of the disclosure.
[0010] FIG. 2 is a further illustration of the airless intravenous bag
according to one
embodiment of the disclosure.
[0011] FIGs. 3 and 4 are further illustrations of the second chamber of the
airless
intravenous bag according to one embodiment of the disclosure.
[0012] FIG. 5 is a front view of the airless intravenous bag in the open
position.
[0013] FIG. 6 is a front view of the airless intravenous bag in the closed
position.
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[0014] FIG. 7 is a further illustration of the airless intravenous bag in the
open position.
[0015] FIG. 8 is a further illustration of the airless intravenous bag in the
closed position.
[0016] FIG. 9 is a front view of the airless intravenous bag shown filled with
I.V.
solution.
[0017] FIG. 10 is a further illustration of the airless intravenous bag shown
filled with
I.V. solution.
DETAILED DESCRIPTION OF THE FIGURES
[0018] The present disclosure provides for an airless intravenous (IV) bag
which contains
a specialized device, referred to herein as the airless intravasculature
infusion device
(AIVID). The AIVID allows one to view the amount of fluid in the IV bag and
substantially
decrease or completely prohibit the risk of an inadvertent air infusion.
[0019] In the following description, numerous specific details are set forth
in order to
provide a thorough understanding of the present invention. It will be obvious,
however, to
one skilled in the art that the present invention may be practiced without
these specific
details. In other instances, well-known aspects of intravenous bag systems
have not been
described in particular detail in order to avoid unnecessarily obscuring the
present invention.
[0020] As shown in FIG. 1, the disclosed airless intravenous bag 10 comprises
a standard
pliable plastic IV bag that is divided into two asymmetrical compartments
along its vertical
axis. the larger of the two compartments, referred to herein as the IV
solution compartment
12 holds the IV solution to be infused into the patient devoid of any air. IV
solution
compartment 12 is comprised of a pliable plastic bag. The second, smaller
compartment is
air chamber 14.
[0021] As shown in further detail in FIG. 2, air chamber 14 is comprised of
two parts, air
reservoir 16 and air column 18. The air reservoir 16 is separated from the IV
solution
compartment 12 by horizontal seam 20. Air reservoir 18 is also comprised of
the same
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pliable plastic material as IV solution compartment 12. Air column 18 is
comprised of a hard
plastic column separated from IV solution compartment 12 by vertical seam 22.
Air column
18 also comprises a mesh network 24 at the top of air column 18, and between
air reservoir
16 and air column 18. Air column 18 terminates into funnel aperture 26.
[0022] Surrounding funnel aperture 26 is airless intravasculature infusion
device (AIVID)
28. AIVID 28 is constructed of soft pliable plastic and include hard plastic
half beads 38
embedded within the soft pliable plastic matrix of AIVID 28. Shown in FIG. 2
at the base of
funnel aperture 26 is buoyant bead 30. Extending down vertically from funnel
aperture 26
and into IV solution compartment 12 is solution channel 32. IV solution
compartment 12
then terminates at its base with an injection port 34 and a docking port 36
for the IV drip
chamber.
[0023] IV bag 10 also comprises a pre-cut tab 40 for hanging the IV bag 10, as
needed,
and printed measurement markings 42 on the outside of IV bag 10.
[0024] Turning now to FIG. 3 and FIG. 4, air column 18 and its features are
illustrated in
further detail. The IV solution compartment 12 is connected to AIVID 28 at the
base of IV
bag 12. AIVID 28 is a small less pliable plastic component that has a small
channel (solution
channel 32) through it center that connects it to air column 18 (part of air
chamber 14). Air
column 18 also contains the top of the AIVID 28 which forming a funnel that
decreases in
size from top to bottom, referred to herein as funnel aperture 26. Stretching
upwards from
funnel aperture 26 is a long clear harder plastic tube, as described above,
air column 18. Air
column 18 is designed so that it cannot be easily compressed.
[0025] As shown specifically in FIG. 4, the top of air column 18 has a thin
mesh, namely
mesh network 24, over the top of air column 18, but still opens into a small
compartment, air
reservoir 16 where air can be stored. As noted above, air reservoir 16 is
comprised of the
same pliable material as the IV solution compartment 12.
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[0026] As shown in FIGs. 9 and 10, the primary purpose of the air reservoir 16
is to allow
one to visualize the fluid level 52, including the remaining fluid in the IV
solution
compartment 12 without the risk of inadvertent air administration. As shown in
FIGs. 9 and
10, this is accomplished with a small blue or red colored buoyant bead 30 that
floats on the
surface of the IV solution in solution channel 32.
[0027] Turning now to FIGs. 6 and 8, when the buoyant bead is just below the
funnel
aperture 26 in AIVID 28, this is considered the closed position. FIGs. 6 and 8
specifically
illustrate the details of the "closed position" of IV bag 10. The "closed
position" is required
for shipping purposes. Specifically, when IV bag 10 with buoyant bead 30 is in
the closed
position, a barrier is formed effectively blocking the solution channel 32 so
that IV solution
and/or air cannot traverse to opposite sides (enter each other's
compartments). This is
facilitated by the tight fit of the buoyant bead 30 within the AIVID 28. The
"closed position"
may also be referred to as the "locked position."
[0028] Then when the IV bag 10 is hung and ready for use, the medical
professional then
pinches the AIVID 28, at half beads 38, between his fingers. The directed
pressure of the
fingers being squeezed on each half bead 38 in AIVID 28 is sufficient to
squeeze the buoyant
bead 30 from its "closed" or "locked" position. The buoyant bead 30 then rises
upwards into
funnel aperture 26, as described below with reference to FIGs. 5 and 7.
[0029] As shown in FIGs. 5 and 7, the IV bag 10 is now in the "open position."
Once the
buoyant bead 30 has been dislodged from the solution channel 32, IV solution
is allowed to
rush upwards filling air column 18. Air column 18 will fill to a level
(meniscus 52)
corresponding to the level of the IV solution in IV solution compartment 12.
As air column
18 fills with IV solution, the air in air column 18 is pushed into air
reservoir 16 through mesh
network 24. Mesh network 24 at the top of air column 18 serves to keep the
buoyant bead 30
from inadvertently entering the air reservoir 16 and becoming trapped.
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[0030] As noted above in reference to FIGs. 9 and 10, measurement numbers 42
and
corresponding lines are printed on the outside of IV bag 10 so that the
medical professional
may observe the amount of IV solution being used. The medical professional can
then easily
view the amount of IV solution left by visualizing the buoyant bead 30 on the
meniscus 52
formed within air column 18 and then comparing that to corresponding
measurement number
42 printed on the outside of IV bag 10.
[0031] As the IV solution is dispensed, the IV solution compartment 12
empties. As the
IV solution compartment 12 empties, the fluid level (indicated by meniscus 52)
within the air
column 18 also begins to drop. Air from air reservoir 16 then replaces the
vacant space left
by the dropping meniscus 52. A particular unique and novel feature of IV bag
10 is that
when the IV solution compartment 12 reaches a very low residual volume, the
meniscus 52
begins to drop into the funnel aperture 26 of the AIVID 28. As this happens,
buoyant bead
30 floating on the surface of meniscus 52 is slowly aligned to the center by
the walls of
funnel aperture 26. As the very last amount of IV solution is draining from
the IV bag 10,
and consequently also from air column 18 through solution channel 32, buoyant
bead 30 is
guided down atop the opening to solution channel 32. This effectively blocks
any air from
crossing back through solution channel 32 into IV solution compartment 12. In
preventing
air from crossing back into IV solution compartment 12 this consequently also
prevents air
from entering into the IV tubing itself.
[0032] Thus, when the IV bag 10 is completely emptied, or "runs dry," the IV
solution
compartment 12 completely collapses forming a small vacuum force that is
transmitted
through the solution channel 32 of AIVID 28. This in turn then holds buoyant
bead 30 tightly
locked in the opening of solution channel 32 at the bottom of funnel aperture
26. This in turn
effectively blocks any air from passing into intravenous solution compartment
12.
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[0033] When IV bag 10 runs dry, it simply stops dripping. The IV solution from
compartment 12 and IV tubing in docketing station 36 stop flowing. The result
is that no air
enters the line and another bag can be hung without the need for priming the
line.
[0034] Therefore, this new novel airless intravenous bag system allows a
medical
professional or other user to accurately measure the amount of IV fluid given,
while reducing
the risk of an inadvertent air infusion. Ultimately then, the presently
disclosed airless
intravenous bag system reduces or eliminates the potentially life threatening
or disabling
consequences of air infusion into a patient via the IV line.
[0035] The present invention may be embodied in other specific forms without
departing
from its spirit or essential characteristics. The described embodiments are to
be considered in
all respects only as illustrative and not restrictive. The scope of the
invention is, therefore,
indicated by the appended claims rather than by the foregoing description. All
changes
which come within the meaning and range of equivalency of the claims are to be
embraced
within their scope.
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