Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
I
BACKC~OUND OF THE INVENTION
In certain surgical operations, for example and in particular in
heart surgery, and also in the case of severe injuries or wounding,
a patient Roy very often suffer from substantial blood losses which
must be ccmp~nsated by irr~nediate blood transfusion if the life of the
patient is not to be put at risk. Particularly in the case of surgical
operations, the loss of blood is such that the blood which has been lost
frorrl the body is often still available, namely being in the form of
accumulations of blood in cavities in the body of the patient, to which
the surgeon has relatively ready access. It is therefore already known
for the blood to be collected from such accumulations in the body, and no-
infused into the same patient. Such a procedure which involves collecting
the blood from and reinfusing the collected blood into the same patient
is referred to as intra--ope{ative auto transfusion.
Particularly in the case of heart surgery, for the purposes of performing
auto transfusion, it is known for the patient to be connecter to a heart
lung machine for sucking the blood from the patient by means of pumps
installed in the machine and resupplying the blood to the patient. However,
such machines are extremely expensive and are therefore not available in
every operating theater, while in addition, in spite of the blood being
carefully treated in machines of that type, the blood, being a fluid that
is very sensitive and easily damaged, may nonetheless suffer a certain
amount of damage in its comparatively long path of flow through the machine
from the patient and back to the patient again.
In an effort to remedy that problem, an apparatus has been put forward,
for receiving and reinfusing a patient's Cowan blood, wherein the blood
is sucked in by way of a suction head, a suction line connected thereto and
a suction connection, into a rigid container. The container cc~nun~cates
by way of at least one further connection with a vacuum source which is
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operative to produce, within the container, the reduced pressure required
for sucking the blood from the patient. The container may have for
example a capacity of about 2000 cm2, and when the container is completely
or substantially filled, the suction line is clamped off, the line
connecting to the vacuum source is disconnected from the above-mentioned
further vacuum connection and a conventional infusion figment, possibly
with a blood filter disposed on the upstream side thereof, is then fitted
to the further connection from which the suction line was removed, so that
the blood in the container can be infused back into the patient in the
usual manner.
Although that arrangement has the advantage that the blood can
be taken from the patient over a short flow path, thereby substantially
avoiding damage to the blood, nonetheless it suffers from some disadvantages
which mean that it is not entirely satisfactory. A major disadvantage
is that that apparatus can only be used to reinfuse the blood from the
container, into a blood vessel in the patient, in the manner of a
conventional blood transfusion. As however an auto transfusion operation
of the kind concerned herein is effected whenever a patient has suffered
serious blood losses, it is also a point of major importance that the
blood is reinfused back into the patient in the shortest possible
time, as otherwise the patient may suffer from a considerable deficiency
of body blood, such as to endanger the patient's life, over a
considerable period of time. Such rapid reinfusion of blood can
generally only be achieved by pressure infusion of the blood taken from
the patient, but the above-described known apparatus is not designed
to perform such pressure infusion and in addition, in consequence, such
a pressure infusion cannot be effected without the danger of inducing
an air embolism in the patient. Another disadvantage of the known
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apparatus is that, after an accumulation of blood in the patient's body
has been drawn into the container, it is necessary to prevent air Fran
being drawn into the container after the blood, which is effected by
the suction line being closed off by means of a clamp; however, the
suction force produced by the vacuum source still continues to apply a
suction effect within the rigid container, and that may also give rise
to the not inconsiderable danger of damaging the blood, as for example
the reduced pressure or suction force may cause excessive expansion of
the red blood corpuscles, and may even cause them to burst.
In another apparatus for interpretive auto transfusion,
which is similar to the apparatus just discussed above, the patient's
blood is initially sucked into a rigid container and then reinfused into
the patient from that container by means of a blood pinup (see US patent
specifications No 4 047 526 and 4 033 345). In one embodiment of that known
apparatus, the blood pump which is connected to the container is formed by
an axially compressible concertina or harmonica-like arrangement which is
releasable connected to the container and which can be operated to produce
a vacuum which can overcome the vacuum in the rigid container. The harmonica-like
arrangement is disconnected from the rigid container, after it is filled
with blood, and handed over to the anesthetist for the purposes of the
reinfusion operation. In another form of the known apparatus, the blood
pump is formed by a further container and is non-releasably connected
to the rigid container in which the blood is received Fran the patient's body.
The blood pump has a third inner, yield ably deformable container, and a
respective check valve at its inlet and its outlet. The deformable container
is can pressed and re-expanded by alternately applying an increased pressure
and a reduced pressure to a connection on the deformable container, so
that in that way, and with the two check valves being suitably operative, the
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Z'~6~33
blood is sucked out of the first rigid container and then passed on to
the patient through the outlet valve.
Although that apparatus permits the blood to be rapidly reinfused
into the patient, it suffers frock the disadvantage that the blood acmes
into contact with a comparatively large surface area which is foreign
to the blood, namely the surfaces in the rigid container and in the blood
pump, while in addition there is the danger for the blood to be
detrimentally effected and possibly damaged by the vacuum produced in the
blood pump, being a stronger vacuum than that in the rigid container.
SUMMARY OF To INVENTION
An object of the present invention is to provide an auto-
transfusion apparatus which does not suffer from the disadvantages of
the above-discussed prior art.
Another object of the present invention is to provide an
auto transfusion apparatus which can take blood Fran a patient over a
short flow distance and without damage, and also quickly reinfuse
the blood over a short flow distance, again without damage.
Still another object of the present invention is to provide
an auto transfusion apparatus which is simple and reliable in operation.
Yet another object of the present invention is to provide
an auto transfusion apparatus which constitutes a fully independent and
self-contained unit not requiring other vessels or containers for performing
the reinfusion operation.
A further object of the present invention is to provide an
auto transfusion apparatus which is operable to produce pressure infusion
of the blood in order to restore the blood to the patient rapidly and
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without the risk of air embolism.
To achieve these and other objects, in a first aspect, the
present invention provides an apparatus for receiving and reinfusing
a patient's own blood, comprising a readily deformable container
having a first connection for drawing blood from the patient by way
of a suction line, and a further connection adapted to be connected
to a reduced pressure or suction source, thereby to produce within the
container the reduced pressure or suction force required to draw the
blood from the patient. Disposed around the deformable container is
a further rigid container which thus encloses the deformable inner
container. The outside of the inner container and the inside of the
outer container between them thus define a space to which there is
connected a closable pressurizing corunection, for the solute eddy
of a pressure medium into the space between the inner and outer
containers
In the construction in accordance with the principles of the
invention, as just set out above, blood is sucked in by way of the
suction connection, by virtue of the reduced pressure or suction force
obtaining in the outer or rigid container and within the readily
deformable container. The reduced pressure in the container cannot result
in collapse of the inner easily deformable container as, during the
suction operation, the further space defined between the outside of the
easily deformable, inner container and the inside wall of the rigid
container is closed relative to the exterior, for example by a plug
member or the like which is fitted to the pressure connection, or by
the pressure connection being connected, during the suction operation, to
a source producing a lower reduced pressure. When the container is
suitably filled with blood, the suction line is clamped off or the suction
I 3
connection itself is closed in a suitable manner, for Sample by means
of a valve. A pressure source, for example a manually operable hand
inflator of rubber ball type, is new connected to the pressure connection
so that a pressure medium, in a controllable am unto and under a
controllable pressure, can then be introduced into the further space
outside the outer or readily defol~ble container. As the rigid inner
container does not experience any definition under the pressure of the
pressure medium introduced by the pressure source, the blood contained
in the inner container is subjected to a pressure corresponding to the
pressure of the pressure medium introduced, whereby, after the arrangement
is connected to the patient by way of a pressure infusion fitlnent and
possibly a blood filter connected to the upstream side thereof, the blood
can be runoffs into the patient, in a short time.
It will be appreciated that the blood contained in the inner
container is subjected to the pressure force from the exterior over a large
area, more particularly, over the area of the outside of the readily
deformable inner container, so that there is no serious danger of squeezing
the red blood carousels or otherwise damaging the constituents of the blood,
which may frequently suffer damage of that kind when passing through pumps
and by coming into contact with materials which are not entirely
compatible with blood. It will also be appreciated that the inner container
which accommodates the blood and which is preferably in the form of a
bag or pouch, similarly to the conventional bags or pouches for blood
transfusions, is made from a material which is compatible with blood, for
example polyethylene, silicorerubber, PURR PVC, and the like.
The bag or pouch which preferably constitutes the inner container
is desirably of such a configuration that, in the undeformed condition, it
substantially follows or matches the contour of the inside wall surface
93
of the outer rigid container and is sealingly corrected to the inside
wall of the rigid outer container, preferably in the vicinity of the
suction connection and the further connection thereon. The join may be
made by adhesive or by suitably welding the suitably selected plastic
materials forming the outer and inner containers. In another advantageous
feature of this form of the apparatus according to the principles of the
present invention, which is of advantage from the manufacturing process
point of view, the inner container is made for example from a suitable
plastic film or foil, and connection nozzles or connecting means comprising
a hard material are welded into the bag at the two ends thereof, the
outside surface of the connecting nozzles or members forming respective
sealing surfaces which are co-operable with corresponding sealing surfaces
at apertures in the outer container, through which the connecting members
therefore sealingly extend. slat arrangement may be produced for example
by sealing rinc3s or the like being fitted into one of the respective
pair of sealing surfaces in question. It is also possible however to use
adhesive means or plastic welding at that location.
Instead of the idler container being in the form of a bag or
pouch, it may alternatively be in the form of an axially compressible
folding bellows or concertina-like container, with at least one of the two
connections being formed thereon, by means of a connecting nozzle or like
connecting member. If the connections are at the two ends of the axially
compressible container, although it should be appreciated that that is
not necessarily the case, one such connection must then be guided
slid ably and sealingly in a suitable aperture in the outer rigid container
so that the blood contained in the inner container can be discharged
therefrom by pressure medium introduced into the space defined between
the inner container and the outer container, for reinfusion purposes
Jo ZZ~ 3
In another aspect, the above-indicated objects of the present
invention are achieved by an auto transfusion apparatus comprising a
container having a suction connection for drawing blood from the
patient and a further connection connectable to a suction source, for
producing a reduced pressure in the container to draw blood whereinto.
}however, whereas in the above-discussed first aspect of the invention,
the container is render rigid by virtue of suitable selection of
the material and the wall thickness of the outer container, this
second aspect of the presort invention provides that the container for
receiving the blood is an axially canpressible concertina-like enclosure
which is rendered axially rigid or non-deforrnable by a rigid mounting
means or holder structure which is adapted to be secured to mutually
oppositely disposed ends of the concertina-like container, to prevent
collapse thereof under a reduced pressure in its interior. The concertina-
like container canprises a material which is of suitable bending strengthened the wall thickness thereof is so selected that, although the
concertina-like container is axially compressible in the above-indicated
manner, by virtue of for example a film hinge-type configuration
at the bend edges where the individual fold portions of the concertina-
like container are joined together, nonetheless the concertina-like
container does not experience any deformation or deformation to any
substantial extent, in the radial direction, because of the stiffness and
rigidity achieved by virtue of the concertina-like construction.
By virtue of a rigid holding or bracing means, for example a
frame arrangement or a support structure, in which the concertina-like
container may be fitted, when in the expanded condition, in such a way
that the support structure secures positive connecting elements at the
ends of the container, it is possible to provide that, when the reduced
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pressure is applied to the container, it still remains in its expanded
condition, so that blood can then be sucked into the interior of the
container by way of the appropriate suction connection thereon. When
the container is then completely or substantially filled, the arrangement
S is closed off in a similar manner to that described above, to stop the
further intake of blood. In this form of the apparatus according to the
principles of the present invention however, the blood is reinfused into
the patient not by connecting the apparatus to a pressure medium source,
but by compressing the blood-containing enclosure in the axial
direction. The compression operation to cause reinfusion of the blood
may be carried out in various different ways, for example, Noel,
as by an anesthetist, by putting it into a pressure arrangement, for example
an inflatable pressure sleeve, or the like. manual compression in particular
has the advantage that it is then possible for the anesthetist to more
sensitively control the pressure, than can be achieved for example by
using a feed of pressure air.
Having regard to the above-mentioned disadvantage of the known
apparatus, whereby there is the danger of damage to the blood due to the
reduced pressure within a rigid container continuing to act on the blood
therein, although the suction line has been closed off as by means of a
clamp, a development of the apparatus of the present invention, in
the first-mentioned aspect and in the further aspect referred to above,
provides that a pressure limiting means is disposed in the suction line
connecting to the suction source, in order to limit the reduced pressure
which can be produced in the blood-containing container. A simple form
of such a pressure limiting means may comprise a portion of hose comprising
silicorerubber, which is adapted to collapse at a given reduction in
93
pressure therein. If the suction force reaches a pressure which is critical
to the blood, the collapsible hose portion is compressed by the pressure
difference between its interior and its exterior, thereby preventing further
evacuation of the blood-containing container.
In a further aspect of the invention which is also based on
the principle of the teaching of this invention of pressure reinfusion of
the blood drawn from the patient, in a careful manner, the apparatus comprises
a container for receiving blood drawn from the patient, in the form of
an axially compressible concertina-like container which can be returned
from a compressed condition to an extended condition by resilient means
such as the inherent resiliency of the material constituting the container
and/or by an external force which engages for example the ends of the
container. Operatively associated with a suction connection for drawing blood
from the patient is a check valve which is operable to open in such a
direction as to punt a flow of blood into the container, while operatively
associated with a further com~ection for reinfusion of blood from the
container is a check valve which opens to permit a flow of blood out of
the container.
In this further aspect of the invention, the suction effect is
generated by expansion of the axially compressible container, from an
initially compressed condition, such expansion being caused by inherent
elasticity of the material constituting the container and/or a spring
force. In order to ensure that the blood is not subjected to treatment
likely to cause damage thereto, the degree of suction applied can be
controlled by the extent to which the container is initially compressed.
In this construction also, the material and the wall thickness of
the compressible container is so selected that the reduced pressure which
occurs upon expansion of the container, in the interior of the container,
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does not result in the side walls of the container being deformed inwardly,
as by the corrugated con figuration of the container being inverted in an
inward direction; that non-deformable effect can be readily achieved,
by virtue of the higher degree of inherent stiffness of the corrugated-
-5 like configuration of the container. The check valves provided in the
various collections of the container ensure that the blood which is sucked into
the container cannot reverse its flow through the respective connection ,
and that the reduced pressure in the container, which is required for
drawing the blood whereinto, is not destroyed by in flowing air from the
connection which is subsequently to be used for the reinfusion operation.
In the apparatus in accordance with this aspect of the present invention
also, reinfusion can be effected by manually or mechanically compressing
the container, in the same way as referred to herein before.
The above-mentioned valve assembly in the container also enables
a surgeon if necessary to recompress the container by hand, when in an
only partially filled condition, so that air also contained in the
container is discharged through the check valve which is operative to
open in an outward flow direction so that, by releasing the container
again, further blood can be drawn into the container, to fill the part of
the interior space therein from which the air was discharged by the fresh
compression effect. In order in that situation to ensure that, when the
container is compressed in order to discharge the air therein, blood is not
also discharged from the container with the air, a preferred feature of
this aspect of the invention provides that disposed upstream of the second
check valve operatively associated with the further connection is a check
valve operative to prevent a flow of liquid out of the container, the
check valve being operative to check a flow there through only when that
flow is constituted by a liquid. Such a liquid check valve may be for
2;~6 ~93
ex~nple a pivotal fin or foil cushion which is arranged, upstream of
said connection, within the compressible container, or alternatively
a ball member which is heavier than air but lighter than liquid.
Zen therefore the blood reaches the opening of the further connection,
due to compression of the compressible container, the above-mentioned
fin or foil cushion or ball member, which up ill then could not produce
its flow-blocking action while the air was being discharged from the
container by compression thereof, floats up on the blood as it moves
towards the further connection, and causes that connection to be closed off.
It would also be possible to use a hydrophobic filter means as the
liquid check valve
It will be appreciated that in all the basic aspects and
embodiments of the apparatus in accordance with the principles of this
invention, as set out above, the respective containers comprise materials
which are acceptable and compatible from the physiological point of view,
for example, polyethylene, polyurethane or polyamide, and are preferably
also transparent or translucent to make it possible to monitor the
level of blood in the container.
Further objects, features and advantages of the present
invention will be apparent from the following description of preferred
embodiments, given with reference to the accanpanying drawings, and
from the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 shows a view, partly in longitudinal section, of the
container assembly of a first embodiment of the apparatus in accordance
with the invention, wherein some components of the apparatus, being
components which will be apparent to the man skilled in the art, are not
illustrated in fully detailed form, for the sake of simplicity and clarity
of the drawing,
- 12
Z2tj493
Figure 2 shows a diagrammatic view in longitudinal section through
the container arrangement in accordance with a second emkcdiment of the
apparatus according to the invention, and
Figure 3 shows a view in longitudinal section, similarly to
Figures 1 and 2, of the container arrangement of a third embodiment of
the apparatus according to this invention.
Description OF PROOFREAD EM~DDI~NTS
Reference will now be made to the accompany yin drawings
showing various components and features of the apparatus according to the
present invention, as will now be described.
The embodiment of the apparatus of which the major part is
shun in Figure 1, for receiving and reinfusing blood, comprises a
container arrangement which is generally denoted by reference numeral 1.
Connected to the container arrangement 1 is a suction line or conduit
2 which can be closed off by any suitable means, such as a clamp,
and which in turn can be connected to a suction head for sucking blood
into the apparatus. The container arrangement 1 is also connected to a
releasable vacuum or reduced pressure or suction line or conduit 3,
for connection to a reduced pressure or suction source, for example a
vacuum pump, as diagrammatically indicated at 4. It should be noted at
this point that the apparatus can also be connected to a per so known
infusion figment or instrument, possibly with a blood filter disposed
upstream thereof, which can be connected to the container arrangement 1
in place of the line 2 or the line 3, and which serves for reinfusion of
blood contained in the container arrangement 1, as will be described
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hereinafter.
ho will be readily apparent from Figure 1, the container
arrangement 1 comprises an outer container 11 which is of a rigid form
by virtue for example of the material used and the wall thickness employed,
and an inner, readily deformable container 12 which is disposed within the
outer container 11 and which may be for example in the form of a bag
or pouch of any suitable material. The outer rigid container 11, which
may ye of any desired configuration but which is desirably substantially
cylindrical, and which is substantially closed at its respective ends, as
clearly shown in Figure 1, is provided with apertures 13 and 14 at its
two opposite ends. As shown in Figure 1, each of the apertures 13 and
14 is surrounded by a collar portion which extends generally outwardly
in the axial or longitudinal direction of the container 11, to form a
kind of neck configuration. The purpose of the neck configurations at
apertures 13 and 14 will become apparent below.
At its opposite ends, the bag or pouch 12 also has openings into
which are fitted connecting members or nozzles as indicated at lo,
being secured to the bag or pouch 12 for example by a welding operation.
The connecting members 15 comprise a comparatively rigid plastic material
to which the suction line 2 and the reduced pressure line 3 can be
connected by means of suitable hose coupling arrangements diagrammatically
illustrated in Figure 1. When the bag 12 is in the substantially undeformed
condition shown in solid lines in Figure 1, the bag 12 is of a shape
which substantially corresponds to the inside contour of the outer container
11 so that, in that condition, a closed space 16 defined between the
outside of the inner bag 12 and the inside wall surface of the outer
container 11 is of comparatively small volume. The space 16 is closed
relative to the exterior of the container arrangement 1 by virtue of the
14
'J-22tjL~93
outside surface of the connecting members 15 being sealed to the inside
surfaces of the neck portions around the apertures 13 and 14 in the
outer container 11. That sealing effect is produced for example by
welding, by adhesive means, or by seals which are fitted into the
S respective sealing surfaces, and the like. In that way, the space 16
between the inner container 12 and the outer container 11 is accessible
only by way of a pressure connection indicated in diagrammatic form at 17,
which is provided on the wall of the outer container 11. The pressure
connection 17 can be closed off, when not in use, by a removable cover as
indicated at 18, while, in use of the arrangement, a pressure line 19
which is connected to a pressure medianly source snot illustrated in the
drawing) can be connected to the pressure connection 17 after the
cover 18 has been removed.
The outer container if has a scale 20 to permit the level of
filling of blood in the container arrangement 1 to be read off.
The wall thickness and the material of the outer container 11
are such that the outer container 11 is capable of withstanding the
pressure forces occurring, both from the outside and from the inside,
without substantial deformation. On the other hand, the bag or pouch
12 comprises a thin and easily foldable or deformable plastic film or
foil material, for example polyethylene.
The line 3 incorporates a hose portion 21 comprising an easily
deformable material such as silicone rubber to act as a reduce pressure
limiting means, in order to ensure therefore that the reduced pressure
generated within the inner container 12 by the source 4 cannot fall
below a given pressure at which damage to the blood in the container 12
might occur.
Z2t~ 3
The made of operation of the construction illustrated by way
- of example in Fuller 1 is as follows:
When, for example in the course of a surgical operation, blood
accumulates in a cavity in the body of the patient being operated on,
blood may be sucked therefrom by means of the present apparatus by
connecting the line 3 to the reduced pressure source 4 while the suction
line 2, with the suction head thereon, is introduced by the surgeon or
an assistant into the accumulation of blood which is to be sucked away
from the patient. us a result of the reduced pressure generated within
the bag 12 by the source I, blood is then sucked into the bag 12. As,
at that time, the space 16 is sealed relative to the exterior by the
cover 18 fittc~ on the pressure connection 17, or is alternatively
also connected to the reduced pressure source 4 by way of a suitable line
(not shown), the reduced pressure obtaining in the interior of the bag 12
cannot cause the bag 12 to fold or collapse inwardly. On the contrary, the
bag 12 remains substantially in the condition shown in Figure 1, as
movement of the bag 12 inwardly away from the wall of the outer container
11, under the effect of the reduced pressure produced within the container
12, is opposed by the reduction in pressure in the space 16, which would
occur when the wall of the bag 12 moves inwardly, so that the bag 12
is thus held in a condition of equilibrium, balanced between the pressure
within the bag 12 and the pressure in the space 16. When the bag 12
and thus the container 11 is substantially filled, or when the accumulated
blood in the patient has been sucked away into the apparatus, the
suction line 2 is closed off by a suitable means such as a damp (not
shown), the reduced pressure line 3 is disconnected, and a pressure infusion
fitrnent or instrument (not shown), possibly with a blood filter
disposed upstream thereof in the usual way, is connected to the connecting
-- 16
~.22~;~93
means 15 from which the line 3 has been disconnected. The needle of the
pressure infusion instn~ment has already been inserted into one of the
patient's blood vessels, and secured in place. The cover 18 is now
removed from the pressure connection 17, or, where the pressure connection
S 17 has also been connected to the reduced pressure source 4, that connecting
line is also disconnected from the pressure connection 17, and in its
place, the pressure line 19 is connected to the connection 17. By a controlled
feed of pressure median, for example caressed gas, into the space 16,
pressure can now be applied to the outside of the bag 12, within the
container 11. That pressure accordingly acts on the blood contained in
the bag 12 and feeds that blood to the patient by way of the connection
arrangement 13, 15 and the pressure infusion instrwnent, the length of
the period of time required for such pressure infusion depending on the
amount of blood to be reinfused and also on the level of pressure
applied in the space it. Figure 1 shows in broken lines the deformed
condition of the bag 12 which will thus collapse inwardly as the blood
is discharged from the bag 12 back into the patient, forming a folded
configuration as that happens.
After the bag 12 has been emptied of all the blood contained
therein, and is therefore in an at least substantially completely compressed
condition, the bag 12 can be re-expanded to its original undeformed
condition, by again connecting the connection 17 to a reduced pressure
source, to draw the bag 12 outwardly into contact with the inside
wall surface of the outer container 11.
Instead of using compressed gas as the pressure medium for producing
the discharge of blood from the container arrangement 1, it is also
possible to cause discharge of the blood contained in the bag 12,
by means of an infusion solution which is supplied by means of a pump.
~!.Z2~93
Reference will now be made to Figure 2 showing a second form of
the apparatus according to the principles of this invention, in which,
instead of comprising the container arrangement 1 with the containers
11, ha and 12, aye, the illustrated apparatus comprises a container in
the form of a concertina-like enclosure, as indicated generality 30.
The wall thickness and the material in the region of the folds 31
defined by the concertina-like container 30 are such that the folds are
not compressed substantially in a radial direction, even when a reduced
pressure obtains within the container 30. On the other hand, in the
10 region of edges 32 at which the portions of the folds are joined together,
the wall thickness of the container 30 is comparatively thin, to constitute
a form of film hinge arrangement, so that the concertina-like container
can be relatively easily compressed in an axial direction, as indicated
by arrow 33.
18
I
At its opr~sitely disposed ends, the container 30 has connections
15 which can be connected to a suction line, and to a reduced pressure line
and a pressure infusion instrument respectively, in the same maimer as
described above with reference to Figures 1 and lay The connections 15
have a rib at their free end, for suitably connecting the respective lines
thereto, as shown in Figure 1 for example, and also a further outwardly
protecting annular rib aye, the purpose of which will now be explained.
As can be clearly seen in figure 2, the container 30 is engaged
by a frame structure or holder means diagrarr~natically indicated at 36,
which is of a generally U-shaped configuration providing respective arms
39 and 35, each of which has a generally forked end portion. In the
expanded condition of the container 30, thus as shown in Figure 2, the
forked end of each of the arms 34 and 35 engages partially around a
respective connection 15, under the annular rib lea thereon, so as to hold
the connections 15 at a spacing defined by the spacing between the forked
ends of the awns 39 and 35 of the holder structure 36, thus also holding
the container 30 in the expanded condition shown. It will be appreciated
that the holder structure 36 and the co-operation thereof with the container
30 are such that the container 30 is held in the expanded condition, even
when a reduced pressure is applied to the interior of the container 30,
in a similar mauler to the reduced pressure produced within the bag or
pouch 12, aye shown in Figures 1 and lo respectively. It is possible for the
two end walls 37 and 38 of the container 30 to be of a stronger or more
rigid construction, or to be provided with a stiffening insert, in order
to prevent the container 30 taking up an inwardly curved configuration at
those points.
In the condition shown in Figure 2, the container 30 fonts the
equivalent to the rigid outer container 11 in the construction shown for
19
I 3
employ in Figure 1. It will be appreciated however that, as the container
30, as soon as it is removed from its position of form-locking engagement
with the arms 34 and 35 of the holder structure 36, represents a readily
deformable container corresponding to the bag or pouch 12 in the
construction shown in Fuller 1, it also performs the function of that bag
or pouch.
More specifically, the made of operation of the construction shown in
Figure 2 is as follows:
First of all, a reduced pressure is produced in the interior of the
concertina-like container 30, by connecting a reduced pressure source to one
of the connections lo. Blood is sucked from an accumulation thereof in
the body of the tent, into the interior of the container 30, by tune
reduced pressure there within, by way of the suction line connected to the
connection 15. When the accumulated blood has been sucked away or when the
container 30 has been entirely or substantially filled with blood, the
suction line is closed off as by means of a clamp, and the reduced pressure
line is disconnected and replaced by a pressure infusion arrangement, in
the same way as described above with reference to Figure 1. The container
30 can now be removed from the structure 36. The blood contained in the
container 30 is then reinfused into the patient by axially cc~npressing the
container 30 in the direction indicated by the arrow 33. As already
mentioned above, the container 30 may be axially compressed either manually
or by introducing the container 30 into an inflatable pressure sleeve, or
by means of another arrangement for applying pressure to the container 30.
Reference is now made to Figure 3 showing another construction in
accordance with the present invention, in which the container for receiving
the blood to be reinfused is in the form of a concertina-like container
40 which in principle is the same as the container 30 shown in Figure 2
493
but which has a higher degree of inherent elasticity than the container
30, by virtue of being of a suitable wall thickness, in the region of the
edges I at which the fold portions defining the concertina-like
configuration are interconnected. The inherent resiliency of the container
40 provides that, after the container 40 has been axially ccsnpressed, it
will autolnatically return to its expanded condition. Such inherent
resiliency can be assisted and promoted by a suitable spring means such
as a spreading spring 43 which is connected to the end surface portions
of the container 40 and which seeks to expand the container q0 in an axial
direction. It would be possible to use such a spring means, instead
of relying on the inherent resiliency of the container 40, as well as
utilizing both inherent resiliency and spring means.
Like the above-described embodiments, the container 40 also has
connections 15. One of the connections 15 can also be coupled to a
suction line 2, in the manner already described above, so that blood can
be sucked into the interior of the container 40. However, in contrast to the
previously described err~odirnents, the other connection 15, being the
upper connection in Figure 3, is not connected to a reduced pressure
source, but instead is used exclusively in the operatiorof reinfusing the
blood, for connecting a pressure infusion instrument of which Figure
3 diagrammatically indicates the connecting pipe and the associated dame
portion of a blood filter 44.
Disposed in the connection 15 to which the suction line 2 is to be
connected is a non-return or check valve 45 which is operative to open
in a direction such as to permit blood to flow into the container 40,
while however being in a closed condition in the opposite direction,
so that blood cannot be discharged from the container 40 through the
lower connection 15 shown in Figure 3. The opposite connection 15
9 3
which is subsequently connected to the pressure infusion instrument as
shown in Figure 3 also has a non-return or check valve 46 which is
operative to open in a flow direction out of the interior of the container
90, Chile however producing its check function in the opposite direction
of flow, namely, inwardly of the container 40. In addition, disposed
in the vicinity of the opening 47 with which the check valve 46 is operatively
associated and which leads to the connection 15 is a light air-filled
film or foil cushion 48 which is so disposed that it hangs downwardly
in the manner shown in Figure 3, under the effect of its own weight. The
cushion member 48 cannot be moved into a position in front of the opening
47, by virtue of a flow of air outwardly of the container through the
check valve 46.
The mode of operation of the construction shown in Figure 3 is
as follows:
Firstly, the container 40 is axially compressed to its minimum
volume by a manual pressure force, for which purpose it is necessary to
overcome both the inherent resiliency of the concertina-like or
corrugated Lyle of the container 30, and also the spring force of the
spring 43, where such is provided. The suction line 2 is clamped off
when the container 40 is in the compressed condition so that no air can
pass into the container 40 and therefore the container 40 is retained
automatically in the compressed condition. If now the suction head (not
shown) connected to the suction line 2 is introduced into an accumulation of
blood for example in the body of a patient, and the clamp closing off the
suction line 2 is slowly released, the inherent elasticity of the
container 40 and also the spring force applied by the spring 43 will cause
the container 40 to expand in its axial direction. That causes an increase
in the internal volume of the container 40, relative to its initial
~.2Z64~93
compressed condition, and blood will therefore be sucked into the
container 40 through the suction line 2 and the check valve 45 which is
thus in an open position. The other check valve 46, being closed, will
prevent the entry of air into the container 40 during that phase of
operation, so that the effect of reduced pressure in the container 40 is
not nullified by an intake of air through the upper connection shown in
Figure 3. If, due to lack of attention or due to a certain amount of
leakage, a certain quantity of air also passes into the container 40 so
that the container is not completely filled with blood, although it has
already expanded to the maximum extent, the surgeon or assistant may
manually compress the container 40 again in order to remove that air frock
the container 90 by way of the connection lo in which the check valve 46 is
disposed. when that occurs, the cushion member 48 ensures that blood cannot
additionally pass through the check valve 46, which would be undesirable.
That is because the member 48 floats up on the surface of the blood
in the container 40 and is thereby moved into a position in front of the
opening 47 so as to close off the opening 47 and prevent blood from escaping
from the connection 15 with the air which is being discharged there through.
When the container 40 is filled with blood in the manner just
described above, it can be used for the reinfusion operation in the same
manner as described above with reference to the embodiment shown in Figure
2. In other words, the container 40 is manually or mechanically compressed
to cause blood to be reinfused into the patient by way of the pressure
infusion figment 44 which is then connected to the connection 15. An
important consideration in that connection is that the cushion member 48
is displaced from its position in front of the opening 47, by the
connecting tube of the blood filter or by the corresponding tube of the
3.~t:~93
pressure infusion fitrnent, so that the rneml>er 48 no longer closes
off the opening 47 and blood can be discharged through the connection
15.
In a modified form of the embodiments illustrated, the connections
5 15 may be arrayed on the same end of the container, in which cafe it
is necessary to avoid short-circuits in regard to the flow of blood,
by suitably extending the connecting structures into the interior of the
container. It is also readily possible for the various valve functions, for
example in respect of the check valves 45 and 46, to be performed at a
10 different position, for example in the lines or conduits connected
thereto, or short line or conduit portions which then themselves form the
connections lo. It will be appreciated that the invention is also
in no way restricted to the kind of connecting configurations illustrated
in the specific embodiments shown herein. It should also be appreciated
15 that, in the embodiment shown in Figure 3, the inherent or natural
resiliency of the container 40 can also be provided by springs or metal
members which are embedded directly in or associated with the plastic
material constituting the container 40.
It will be seen that all the embodiments described herein before
20 enjoy great ease of manufacture. There are many different forms of
concertina-like or collapsible containers available on the market, and
such containers can be readily adapted to the requirements of the present
invention, by only slight modifications (for example, in regard to the
connections). In the case of the construction Sheehan in Figure 1, the
25 outer, rigid container 11 may be formed Fran two container halves which
are joined together in an axial plane, with the bag 12 and its connecting
members being inserted therein before the container halves are joined
together.
to 3
1 As indicated above, the real purpose of the apparatus described
herein is auto transfusion, that is to say, receiving and no- -
infusing a patient's own blood which is sucked for example from
cavities in the patient's body or the like. Because a reduced
pressure is constantly maintained within the container, by
virtue of the reduced pressure source, for example as shown
at 4 in Figure 1, the apparatus is capable of sucking in blood,
even after a blood-air mixture has been sucked in or when only
air is sucked in by virtue of the suction head for drawing in
the blood from the patient owing inadequately immersed in the
blood to be sucked in. However, it should be appreciated that,
by virtue of its design and construction, the apparatus can be
used not only for auto transfusion, but can also be employed
for drainage operations, for example for draining a wound, and
can also be used in particular for blood donors.
With the embodiment according to Fig. 3 it may be thought about
to combine the concertina-like container 40 integrally with
a further container (not shown), so that the lower part of
such combined container has a mere container function, while
the upper part thereof has the combined function as container
and as a pump. For this embodiment it is further advantageous
to extend the lower connection 15 into the interior of the
container, e.g. by means of a short tube, so that a sucked in
mixture of blood and air is not directly drawn through the
reservoir of blood already contained.
In order to avoid clamping of the suction line after accumulated
blood has been sucked away, it is also possible to provide a
check valve in that line.
Various other modifications and alternations may of course be
made in the above-described embodiments and the modified forms
thereof, without thereby departing from the spirit and scope
of the present invention.
