Note: Descriptions are shown in the official language in which they were submitted.
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CROSS REFERENCE TO RELATED APPLI`CATIONS
This application is related to, Canadian application
Serial No. 313,060 Filed: October 11, 1978 Entitled: METHOD
AND APPARATUS FOR PROCESSING BLOOD and Canadian application
Serial No~ 312,103 Filed: September 26, 1978 Entitled:
CENTRIFUGAL LIQUID PROCESSING SYSTEM, both of which are assigned
to the assignee of the present application.
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BACKGROUND OF THE INVENTION
1. Field of the Invention.
The present invention relates to a monitor and fluid
circuit assembly utilized in an apparatus for processing
whole blood and more specifically to a compact disposable
S monitor and fluid circuit assembly for collecting a desired
blood component such as platelets.
2. Description of the Prior Art.
Heretofore various apparatus have been proposed for
processing whole blood and separating the same into the
various components thereof. Such prior art apparatus have
involved intervivos blood processing in which whole blood is
taken from a live donor, separated within a processing
system into its constituent components and a desired
component is segregated for collection from the donor,
followed by returning the remaining blood fluid to the
donor. Typically, the blood components that are separated
are plasma, red blood cells, white blood cells and platelets.
An apparatus and process which are particularly adapted for
separating platelets from whole blood are described hereinafter.
Such a process is commonly referred to as plateletpheresis.
Apparatus for carrying out intervivos blood processing
that have been utilized in the past, have typically included a
separation chamber within which whole blood from a donor is
subjected to a centrifugal force. This is typically accomplished
in a centrifuge device. Because of differences in densities
the various blood components will congregate in different zones
at different radial distances from the center of rotation of
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the separation chamber. Then, collection ports in the
chamber are utilized to remove the blood components from
the various zones in the separation chamber for storage
or recirculation.
Heretofore such devices have required various fluid
couplings and pressure monitor devices which must be
thoroughly cleaned after each use and/or parts of the
fluid system or circuit must be replaced.
As will be described in greater detail hereinafter,
the present invention provides a monitor and fluid circuit
assembly which can be easily mounted on and connected to a
blood processing apparatus and easily detached therefrom
for separation of a blood component collection bag, e.g.,
a platelet bag. Also the assembly is made of inexpensive
plastic materials such that the assembly minus the collection
bag can be discarded.
113~527
SUMMARY OF THE INVENTION
Broadly spea~ing the present invention provides
a portable fluid circuit module comprising flexible first
and second conduit means each defining a fluid pathway
adapted for communication with a source of fluid, and housing
means having sidewalls peripherally defining a hollow interior
and including means on the sidewalls for supporting a portion
of each of the conduit means within the confines of the hollow
interior and for supporting another portion of each of the
conduit means in a predetermined arcuate configuration out-
wardly bowed from one of the sidewalls and resiliently biased
toward an upright position generally perpendicular to the one
sidewall with the outwardly bowed portions of the first and
second conduit means positioned in a spaced, noncontiguous
relationship along the one sidewall to accommodate separate
operative contact with spaced pump rotors.
Furthermore the present invention may be seen as
providing a portable fluid circuit module comprising flexible
first conduit means and flexible first auxiliary conduit
means each defining a fluid pathway adapted for communication
with a source of fluid, and housing means having sidewalls
peripherally defining a hollow interior and including means
on the sidewalls for supporting a portion of each of the
conduit means with the confines of the hollow interior and
for supporting another portion of each of the conduit means
in a predetermined arcuate configuration outwardly bowed from
one of the sidewalls and resiliently biased toward an upright
position generally perpendicular to the one sidewall with the
outwardly bowed portion of one of the conduit means con-
centrically positioned closely adjacent to the outwardly bowed
portion of the other of the conduit means to accommodate
simultaneous operative contact with a pump rotor.
. _ - 5 -
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BRIEF DESCRIPTION OF THE DR~WINGS
Fig. 1 is a perspective view of the apparatus with
which the monitor and fluid circuit assembly of the present
invention is used.
Fig. 2 is an enlarged perspective view of the upper
portion of the apparatus shown in Fig. 1 with the monitor
and fluid circuit assembly of the present invention removed.
Fig. 3 is a schematic bloc~ flow diagram of the fluid
circuit of the assembly.
Fig. 4 is a perspective view of the monitor and fluid
circuit assembly of the present invention.
. Fig. 5 is a fragmentary perspective view of one of
the monitor devices of the assembly.
--- 1131527
DESCRIPTION ~F ~E P~EFERRæ~ EMBO~IMENT
_
Referring now to the drawings in greater detail, a
blood processing apparatus is shown in, and generally identified
by the reference numcral 10 in, ~ig. 1. The apparatus 10
includes the monitor and fluid circuit assembly of the present
invention which is fully shown in, and identified by reference
numeral 11 in, Fig. 4. The apparatus 10 further includes a
centrifuge device hidden from view within the cabinet 12.
The centrifuge device is shown schematically in Fig. 3 and
identified therein by reference numeral 14. Por further
details of the construction and operation of the centrifuge
device 14, reference is made to Canadian application, serial
number 312,103, filed September 26, 1978, entitled:
CENTRIFUGAL LIQUID PROCESSIN~ SYSTEM.
The monitor and fluid circuit assembly 11 includes a
fluid circuit which is generally identified by the reference
numeral 16 in Fig. 1 and which is best shown schematically in
Fig. 3. As will be described in detail in connection with
the description of Figs. 3 and 4, the fluid circuit 16 includes
a plurality of flexible plastic tubings which form fluid
couplings between various parts of the fluid circuit 16. These
tubings are received through a holder 18 which forms part of
assembly 11 and which has monitor devices mounted therein.
As shown in Fig. 1 and 2, several loops of the tubing
(5~,74,102 in Figs. 3 and 4~ are received over, in tight
contact with, and form part of two peristaltic p~ps 20 and 22, As
pc/,~
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will be described in greater detail hereinafter, the pump 20
is referred to as a first or whole blood pump and the pump
22 is referred to as a second or plasma pump. The whole
blood pump 20 is utilized for withdrawing whole blood from
a donor whereas the plasma pump 22 is utilized to move plasma
from one chamber to another chamber within the centrifuge
device 14 (Fig. 3).
The apparatus 10 also includes a display panel 24
including several windows for indicating information useful
to an operator. In this respect, an alarm window 26 indicates
a malfunction of the apparatus 10 or a condition occurring
within the fluid circuit 16 of the apparatus 10. Also there
is a window 28 indicating the blood component which is being
collected, a window 30 indicating volume processed and end
point and a window 32 indicating the elapsed time of operation
of the apparatus 10, the flow rate of the whole blood and the
flow rate of platelet rich plasma.
A number of push buttons 41-47 are provided for
controlling various phases of operation of the apparatus 10,
as well as windows 48 and 49 on the display panel 24 for
indicating the hematocrit of the donor.
Additionally, the apparatus 10 includes a manual control
panel 50 which, as best shown in Fig. 2, includes a plurality
of knobs and switches for manual operation of the apparatus
10. The legends on the manual control panel 50 generally
identify the various toggle switches and push button switches,
the purpose of which will become apparent from the detailed
description of the operation of the apparatus 10 set forth below.
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Referring now to Fig. 3 there is illustrated therein
a block schematic diagram of the fluid circuit 16. As shown,
the circuit 16 includes a first fluid coupling or tubing
54 adapted to be coupled to a vein in one arm of a donor
52 by means of a hypodermic needle 56 which is injected
into the arm. If desired a fluid clamp 58 (shown schematically)
can be provided on the tubing 54. The first tubing 54 has
'
associated therewith a solenoid operated clamp/forming valve Xl.
The tubing 54 then has series coupled thereto an occluded
vein monitor device 62 with an associated sensor 63. Then,
the first tubing 54 extends over and forms part of the peristaltic
pump 20 and is series coupled to a high pressure monitor device
64 with an associated sensor 65. From the monitor device 64
the first tubing 54 extends into the centrifuge device 14 and
to the bottom inlet of a first compartment or receptacle 66
which is identified as a whole blood bag and which defines
therein a whole blood separation chamber.
The receptacle 66 has a first outlet 68 at the center
thereof adjacent a zone in the receptacle 66 where platelet
rich plasma congregates. Receptacle 66 also has two outlets
70 and 72 at the upper corners thereof where red blood cells
congregate. Outlet 68 provides not only an outlet for platelet
rich plasma but also a return inlet for platelet rich plasma
which is "contaminated" (mixed) with red blood cells when
there is a spillover of red blood cells out of outlet 68.
The outlet 68 of the first receptacle 66 is coupled to
a second fluid coupling or tubing 74 which extends to a loop 75
thereof located exterior of the centrifuge device 14 and which
loop extends about and forms part of the peristaltic pump 22.
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Also, positioned adjacent a transparent or translucent
section of the loop 75 which extends out of the centrifuge
device 14 is a spill detector device 76 which is an optical
sensor for sensing a spillover of red blood cells mixed
with platele~ rich plasma. The device 76 includes a light
emitting diode (LED) such as an infra red LED sold by
Texas Instrument under type nu~ber TIL 32 and a phototransistor,
such as a phototransistor sold by Texas Instrument under type
number TIL 81. The second tubing 74 then goes back into
the centrifuge device 14 and is coupled to an inlet 78 of a
second compartment or receptacle 80 which is identified as a
platelet bag defining a chamber therein where platelets are
separated from plasma.
A third fluid coupling or tubing 82 is connected to
the outlets 70 and 72 of the first receptacle 66 andto-the donor
through a high/low pressure monitor device 84 with associated
sensor 85 and an air bubble trap/filter 86 and associated air
bubble sensor 87 which monitor device 84 and filter 86 are
coupled in series in the third tubing 82. Also another sole-
noid clamp 88 is associated with a portion 89 of the tubing
82 coming out of the air bubble trap/filter-86 and forms valve
#3. The sensor 87 can be optical or ultrasonic.
The end of third tubing 82 is connected to a hypodermic
needle 90 for injection into the other arm of the donor and,
if desired, a fluid clamp 92 (shown schematically) can be
provided in tubing 82 ahead of the needle 90.
The fluid circuit 16 further includes a fourth fluid
coupling or tubing 94 which is coupled with an outlet 96 of
the second receptacle 80 and joins a fifth coupling or tubing
127 in which a solenoid operated clamp 98 forming valve #6
is located and which forms a junction 99 with the third tub-
ing 82.
pg/ kS -- 10
The fluid circuit 16 also includes a first container
100 of anti-coagulant such as Acid Citrose Dextrose (ACD)
which is coupled by a first auxiliary fluid coupling or
tubing 102 about (and forming part of) the peristaltic
pump 20 and through a solenoid operated clamp 104 defining
valve #2 to a junction 105 with the first tubing 54 be-
tween the needle 56 and valve #1.
With this arrangement of the first tubing 54 and
the first auxiliary tubing 102 passing over the same peri-
staltic pump 20, the mixing of anti-coagulànt with whole
blood and the withdrawing of whole blood from the donor is
achieved essentially simultaneously. Also, the ratio of
the cross sectional area of the interior of the tubing 54
to the cross sectional area of the interior of the t~bing
102 is chosen to obtain a desired mixture of anti-coagulant
to whole blood. This ratio is preferably 8 to 1 thereby to
obtain an 8 to 1 ratio of whole blood to anti-coagulant.
The apparatus 10 and fluid circuit 16 further include
a second container 108 of saline solution which is connected
by means of a second auxiliary coupling or tubing 110 through
a drip chamber 112 and a solenoid operated clamp 114 defining
valve #4 to the first tubing 54 at a junction 115 between
solenoid operated clamp 60 and the occluded vein monitor
device 62. The container 108 of saline solution is also
coupled by means of a third auxiliary fluid coupling or
tubing 118 through a solenoid clamp 120 forming valve #5
to the top of the air bubble trap/filter 86.
The apparatus 10 and the fluid circuit 16 thereof
further include a third receptacle or compartment 124 located
3~ outside of the centrifuge device 14 for collecting plasma.
This receptacle 124 is coupled to the fourth tubing 94 at
junction 129 by branch coupling or tubing 126 through a
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solenoid oper~ted clamp 128 forming solenoid va~ve ~7.
The operation of the apparatus 10 for proçessing
whole blood through the fluid circuit 16 will now be
briefly described with reference to Fig. 3.
First of all, a donor is chosen who will be a
healthy person donating platelets and who will be treated
much like a blood donor. When the apparatus lO is ready,
two venipunctures will be made, one in each arm~ with
needles 56 and ~0.
Valve #l is opened first to allow saline to purge
the input needle 56 prior to injection in the dono~. Then
valves #1, ~2, #5 and #7 are closed. Valves #3, #4 and #6
are open.
Then, saline is pumped by the first pump 20 through
the fluid circuit 16 until no more air bubbles are sensed
by the air bubble sensor 87, i.e., until s~line is sensed.
Next, the second pump 22 is started and saline is pumped
through the platelet receptacle 80. Since the centrifuge
device 14 is not running at this time, the receptacles 66
and 80 are not filled to capacity. Air is expelled through
the needle 90.
After a short time, e.g., one to five minutes the
platelet receptacle/bag 80 will be filled, all air expelled
and sali~ne fills the entire system, i.e., fluid circuit 16
up to valve #3. When saline is sensed by detector ~7, valve
~3 is closed and valve #S is opened. After a period of
recirculation of saline, pumps 20 and 22 are stopped and valve
#3 is opened.
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Parenthetically, during this priming operation, the
air bubble sensor 87 is checked when air bubbles are flowing
through the air bubble trap/filter 86 to make sure that
sensor 87 is working properly and then later, sensor 87
is checked to make sure there are no more bubbles after
the system is filled with saline.
Now the needles 56 and 90 are inserted into the arms
of the donor 52 and valves #1, X2, #5 and #6 are open and
valves #3 and #7 are closed.
With the needles 56 and 90 connected to the veins
of a donor and the system full of saline, the pumps 20
and 22 are started and whole blood is pumped into the system
and into the centrifuge device 14.
It will be noted that the tubings 54, 74, 82 and 94
extending into the centrifuge device 14 may be combined in
an umbilicus (139 in Fig. 4 ) which is rotated at a speed 1/2
the speed of the centrifuge device 14 so that twisting is
avoided and no fluid seals are required. This arrangement
and operation of the ce~ rifuge device 14 is more fully
~0 ~7
~ described in the co pcnding application entitled: CENTRIFUGAL
LIQUID PROCESSING SYSTEM referred to above.
When approximately 120 milliliters of whole blood has
been pumped into the fluid circuit 16, most of the saline
solution will have been pumped back into the container 1~8.
Valve #3 is now opened so that processed blood fluid mixed
with some saline solution can now be returned to the donor.
Also, if the plasma collect button had been pushed,
valve ~6 is closed and valve #7 opened and a desire~ amount
of plasma will be co~lected while whole blood is being processed
1131527
through the flUid circuit 16 after which valve ~7 is closed
and valve ~6 iP. Openea .
Afte~ starting pumps 20 and 22 no further operator
attention is required until the end of the run.
As the whole blood is being drawn into the fluid
circuit 16 and into the separation chamber in the receptacle
66, the centrifugal force acting on the receptacle 66 causes
scparation of the components of the whole blood. In this
respect, platelet rich plasma congregates in a zone at the top
Of the receptacle 66 adjacent to outlet 6~ and red blood cells
congregate at the upper corners of the receptacle 66 adjacent
outlets 70 and 72. This is achieved by the particular
construction ana orientation of the receptacle 66 which is
described in more detail in Canadian application serial number
312,103, referred to above.
In one working example of the apparatus 10, the
volumetric displacement of pump 20 is started at an initial
speed and increased by 1 milliliter per minute after each 120
milliliters of whole blood, has been processed through the
fluid circuit 16 without a spillover of red blood cells.
However, when a spillover of red blood cells from the receptacle
66 is sensed by the spill detector device 76, pump 22 is stopped
and then reversed to return the mixture of platelet rich
pl2sma and red blood cells to receptacle 66. Then the speed
of the first pump 20 is decreased ~y one milliliter per minute
an~ the speed of pump 22 is changed proportionately. Both
pu~,ps are then run in the normal direction (forward) until
another 120 milliliters of whole blood is processed without a
spillover. If a spillover is not detected by the device 76,
the speed of the second pump 22 is then increased by .25
milliliters pe~ ~inute for
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each 120 milliliters of blood processed without a spillover
until a spillover is detected. Then when a spillover is
detected, the pump 22 is again stopped and reversed to
return the spillover mixture to receptacle 66. Next the
volumetric displacement of the second pump 22 is decreased
by .25 milliliters per minute, the pump 22 speed reversed
bac~ to forward speed and this process repeated until the
end point of the run is reached. By the end point is meant
that the processing of approximately 3 liters of whole blood
has been completed. Operated in this manner, the apparatus 10
provides a highly efficient and effective separation of
platelet rich plasma from whole blood.
Platelet rich plasma which is withdrawn from the
receptacle 66 is passed through the platelet receptacle or
bag 80. In view of the centrifugal force acting on the
bag 80, platelet sedimentation on the side of the bag 80
takes place while plasma flows through the bag 80. This flow
is enhanced by pinching the bag 80 in the center thereof as
indicated by the wavy line 130 in Fig. 3. This results in
a flow of plasma through the bag or receptacle 80 in the manner
indicated by the arrows shown in Fig. 3.
The plasma that exits from the bag 80 flows through
the tubing 94 and recombines at the junction 99 with the red
blood cell rich blood fluid flowing through the tubing 82.
The recombined platelet poor blood is then passed through
the high/low pressure ~onitor 84 and air bubble trap/filter
86 and back into the donor 52 through the needle 90.
Once a desired amount of whole blood, i.e., 3 liters
of whole blood, has been processed, valves ~1 and #2 are closed
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and valve #4 is opened to allow saline to flow into the
system, i.e., fluid circuit 16. The saline will then
purge the remaining amount of blood in the fluid circuit
16 and push it back into the donor. Then after a sufficient
amount of saline has been pumped into the system the centri-
fuge device 14 is stopped. About 3 milliliters of blood
fluid is left in the system and can be returned to the
donor by allowing a short overrun of the pump 20. The
cabinet 12 now can be opened to sever tubings 74 and 94
such as with a heating element as indicated by breaks 131
and 132 shown in Fig. 3. The sealed platelet receptacle/
bag 80 with a minimum of plasma therein is taken out of the
centrifuge device 14 and stored for use.
Referring now to Fig. 4 there is illustrated therein
the monitor and fluid circuit assembly 11 of the present
invention. As shown this assembly 11 includes the holder 18
through which all tubings except tubing 110 are received and
held. As shown, first and first auxiliary tubings 54 and 102
respectively extend into the bottom of the holder 118 and
out the top thereof to form loops which are juxtaposed to
each other. These loops extending from the top of the holder
18 of the tubings 54 and 102 are received over, and form part
of, the peristaltic pump 20. In a similar manner the second
tubing 7~ extends into the bottom of the holder 18 and out
the top of the holder 18 to form the loop 75 and then passes
back to the holder 18. This loop 75 is received over, and
forms part of, the second pump 22. The valves #1 - #7 are
schematically shown by blocks. It will be understood that
these valves ~1 - #7 are actually solenoid operated clamps
3~ as described above.
pg/ ~ - 16 ~
113~5Z7
The pressure monitor devices 62, 64 and 84 ~re
identical and only one will be described in connection
with the breakaway view of one device shQwn in Fig~ 5.
As shown the device 62, 64 and 84 includes a flow through
chamber 133 series connected in the associated tubing 54
or 84 and an air filled closed chamber 134 having a
flexible diaphram 135 forming part of one wall of the flow
through chamber and an outer wall 136 which is situated
adjacent the associated sensor 63, 65 or 85 which are
pressure transducers and which sense changes in pressure
on the outer wall 136. The monitor devices 63, 65 or 85
and air bubble trap/filter 86 are all mounted in holder 18
in the positions shown in Fig. 4. Also each of the monitor
devices 62, 64 and 84 has a hollow cylindrical protuberance
extending therefrom for fitting about the side of a mating
solid cylindrical pressure sensor 63, 65 or 85 which are
shown in Fig. 2 where the holder 18 has been removed and
not shown in Fig. 4 which only shows the assembly 11. Also,
the transparent section of tubing 75 which is generally
identified by reference numeral 137 in Fig. 4 will be position-
ed adjacent sensor 76 and the transparent section of the air
bubble trap/filter 86 will be positioned adjacent the sensor
87 when the holder 18 is positioned on the upper portion of
the apparatus 10 shown in Fig. 2 and the clamps 19 are moved
to secure holder 18 in place. Note also that a sensor 138
(Fig. 2) of the apparatus 10 will sense when the holder 18
is in place.
The first, second, third and fourth tubings 64, 82 and
94 coming out of the holder 18 are passed through an um~ilicus
139 which is received in a rotating holder of the centrifuge
device 14 as described above.
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n~ /~
- ~1315æ~
f-,~J c7~ 'C'co7,~/
The~containers 100 and 108 can form part of the
assembly 18 and be secured to the tubings 102, 110 and 118
as shown or the assembly can merely include injection type
coupling devices at the outer end of each of the tubings
102, 110 and 118 adapted for connection to one of the containers
100 and 108. Such a coupling device is shown injected through
a membrane at the mouth of the container 108 and is generally
identified by the reference numeral 140. Also these containers
are typically made of a flexible, disposable, plastic material.
It will be understood that the holder 18 is made of an
inexpensive and disposable material, e.g., plastic as are the
tubings and the receptacles 66, 80 and 124. Likewise the
monitor devices 62, 64 and 84 are made of an inexpensive
plastic material so they can be readily disposed of once the
assembly 11 has been utilized in the processing of whole blood
to collect platelets and the platelet receptacle or bag 8
has been removed.
It will be understood that, excluding the holder 18,
the assembly 11 constitutes the entire fluid circuit 16 of
the apparatus 10. Also, with the arrangement of the monitor
devices 62, 64 and 84 in the holder 18, as well as the
positioning of the light transmitting tubing segment 137
and a light transmitting portion of a wall of the air
bubble trap/filter 86 in the holder 18 as shown, a simple and
compact monitor and fluid circuit assembly is provided which
can be easily mounted in place by manipulation of the pivotal
clamps 19 with the loops of the tubings 54, 75 and 102
received over, and forming part of, the peristaltic pump 20
and 22 and with the receptacles 66 and 80 inserted in the
~3~S~7
rotor of the centrifuge device 14 of the apparatus 10.
Then when the processing of a predetermined amount of
whole blood, e.g., 3 liters of whole blood, is completed
the whole assembly 11 can be removed from the apparatus 10
and the tubings 94 and 74 above the receptacle 80 can
be severed and sealed such as with a heating element at
breaks 131 and 132 so that the platelet receptacle 80
can be removed from the assembly 11 and stored for future
use.
From the foregoing description it will be apparent
that the monitor and fluid circuit assembly 11 of the
present invention has a number of advantages some of which
have been described above and others of which are inherent
in the invention. Accordingly, the scope of the invention
is only to be limited as necessitated by the accompanying
claims.
