Note: Descriptions are shown in the official language in which they were submitted.
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TITLE
BIOLOGICAL FLUID FILTRATION METHOD AND APPARATUS
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a method and
apparatus for processing biological fluids into their
therapeutically valuable components. More particularly,
the present invention relates to a method and apparatus
for processing donated blood into its therapeutically
valuable components. Most particularly, the present
invention relates to an improved method and apparatus for
processing donated blood into its therapeutically valuable
components which uses improved open-loop and closed-loop
systems to substantially increase the recovery of all the
blood products from the donated blood.
2. Discussion of the Related Art
Methods and apparatus for processing blood are well
known in the prior art. U.S. Patent No. 3,892,236 to
Djerassi shows an apparatus for the continuous withdrawal
of blood from a human donor, forced extracorporeal
circulation of blood of the donor with separation of
granulocytes, and return by gravity of the leukocyte-poor
whole blood to the donor.
U.S. Patent No. 5,126,054 to Matkovich shows a
venting means for venting gas from the transfer line of a
liquid delivery system comprising a housing, a first,
liquid-wettable, microporous membrane carried in said
housing so as to be in communication with the transfer
line, and a second, non-liquid-wettable, gas permeable
microporous membrane superimposed on said microporous
membrane to the outward side of the housing. Gas in the
delivery system is vented from the system so long as the
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first microporous membrane remains unwetted by the
delivery liquid.
U.S. Patent No. 5,451,321 to Matkovich shows
biological fluid processing assemblies having a gas inlet,
and%or a gas outlet.
While these devices are generally satisfactory, some
of the methods and apparatus of the prior art leave a
large amount of biological fluid trapped in various
elements of the fluid processing apparatus. While the
aforementioned patent 5,451,321 to Matkovich provides for
liquid trapped in various elements of the blood processing
system to be recovered either by causing a volume of gas
behind the entrapped liquid to push the liquid through
those elements and into the designated collection bag, or
by pulling the entrapped liquid into the designated
collection bag by a pressure differential (e.g. gravity
head, pressure cuff, suction and the like), the system
still has several drawbacks. One drawback is that they
require one or more nonwettable, gas permeable, membranes.
This requirement can lead to increased costs over wettable
membranes.
Therefore, those skilled in the art continue to.
search for a method and apparatus to provide for optimal
recovery of the biological fluid from biological fluid
processing systems, cost reduction and ease of use, and
have developed novel open and closed loop systems and
methods associated therewith to achieve this goal.
SUMMARY OF THE INVENTION
The problems of the prior art are solved by the
present invention utilizing novel open and closed loop
biological fluid processing systems which all share the
concept that the gases transferred into, out of, or within
the biological fluid processing system have the transfer
lines arranged or configured in a manner which precludes
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the biological fluid from ever contacting the upstream and
downstream gas inlet or outlet housings or vents, or
bypassing the fluid filtration or leukocyte depletion
device. Gases are transferred into and out of the
biological fluid processing systems through a porous
medium in the upstream and downstream gas inlet housings
or vents. Each housing or vent is separated from, and in
communication with the biological fluid by a column of gas
in the transfer lines. The upstream gas inlet housing or
vent is in communication with the unfiltered biological
fluid and the downstream inlet or vent is in communication
with the filtered biological fluid.
In one embodiment of the present invention, a
biological fluid filtration apparatus is provided which
includes a fluid filtration or leukocyte depletion device
having an inlet and an outlet, a fluid container upstream
from and elevated above said fluid filtration or leukocyte
depletion device and having an outlet, a first conduit in
fluid communication with the outlet of said fluid
container and the inlet of said fluid filtration or
leukocyte depletion device, a receiving container
downstream of said fluid filtration or leukocyte depletion
device and having an inlet, a second conduit in fluid
communication with the inlet of said receiving container
and the outlet of said fluid filtration or leukocyte
depletion device, an upstream gas inlet having one of its'
ends elevated above said fluid container, and having its'
other end in fluid communication with said first conduit,
and a downstream gas inlet having one of its' end elevated
above said fluid container, and having its' other end in
fluid communication with said or leukocyte depletion or
fluid filtration device.
In another embodiment of the present invention, there
is provided a closed loop fluid filtration or leukocyte
depletion device including a fluid filtration or leukocyte
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depletion device having an inlet and an outlet, a fluid
container upstream from, and elevated above, said fluid
filtration or leukocyte depletion device and having an
outlet, a first conduit in communication with the outlet
of said fluid container and the inlet of said fluid
filtration or leukocyte depletion device, a receiving
container downstream of said fluid filtration or leukocyte
depletion device and having an inlet, a second conduit in
fluid communication.with the inlet of said receiving
container and the outlet of said fluid depletion device
and a bypass line in fluid communication with said fluid
container and said receiving container and having a loop
portion elevated above said fluid container.
In yet another embodiment of the present invention
the upstream gas inlet is eliminated and the downstream
gas inlet is connected to the receiving container instead
of the fluid filtration or leukocyte depletion device.
In another embodiment of the present invention, the
downstream gas inlet may be eliminated.
In still another modification of the present
invention, the upstream gas inlet housing or vent and the
downstream gas inlet housing or vent may be part of the
same inlet device.
Thus, it is an object of the present invention to
provide an improved method and apparatus for filtering
biological fluids.
It is a further object of the present invention to
provide an open gas vent that prevents premature gas
introduction into the fluid stream in a biological fluid
processing system.
It is a further object of the present invention to
provide an open loop biological fluid processing system
with transfer lines or conduits arranged or configured in
a matter which precludes the biological fluid from
contacting the upstream and downstream gas inlet housings
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or vents, or bypassing the biological fluid depletion
device.
Another object of the present invention is to offer a
wider choice of materials which may be used in the gas
5 inlet housings or gas outlet housings or vents of
biological fluid filtration systems. The present
invention does not require wettable membranes. The choice
of membranes for the present invention is not limited.
Another object of the present invention is to provide
a system of the foregoing nature where gas is transferred
into and out of the biological fluid processor through
porous medium in the upstream and downstream gas vents.
A still further object of the present invention is to'
provide an open loop system of the foregoing nature where
each gas;vent is separated from, and in communication with
the biological fluid by a column of gas in the transfer
lines or conduits.
A still further object of the present invention is to
provide an open loop biological fluid filtration system of
the foregoing nature wherein the upstream gas inlet
housing or vent, and the downstream gas inlet housing or
vent may be a portion of the same inlet device.
A still further object of the present invention is to
provide a closed loop biological fluid filtration system
having a bypass line bypassing the biological fluid
filtration device, the bypass line is arranged such that a
column of gas separates the unfiltered biological fluid
upstream of the filtration device from the filtered
biological fluid downstream of the biological fluid
filtration device.
A further object of the present invention is to
provide an open loop biological fluid filtration system
having an upstream gas inlet elevated above the level of
the biological fluid container and having a satellite bag
connected to the biological receiving fluid container.
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Further objects and advantages of the present
invention will be apparent from the following description
and appended claims, reference being made to the
accompanying drawings forming a part of the specification,
wherein like reference characters designate corresponding
parts in the several views,
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is an elevational view of a prior art
biological fluid filtration system.
Fig. 2 is an elevational view of a construction
embodying the present invention.
Fig. 3 is an elevational view showing a modification
of the construction shown in Fig. 2.
Fig. 4 is an elevational view of a further
modification of the construction shown in Fig. 2.
Fig. 5 is an elevational view showing a further
modification of the construction shown in Fig. 2.
Fig. 6 is an elevational view of a closed loop
construction embodying the present invention.
Fig. 7 is an elevational view showing a modification
of the construction shown in Fig. 6.
Fig. 8 is an elevational view of a further
modification of the construction shown in Fig. 6.
Fig. 9 is an elevational view showing a further
modification of the construction shown in Fig. 6.
Fig. 10 is an elevational view showing a further
modification of the construction shown in Fig. 6.
Fig. 11 is an elevational view showing a further
modification of the construction shown in Fig. 6.
Fig. 12 is an elevational view of a construction
embodying the present invention utilizing a satellite bag.
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DESCRIPTION OF THE PREFERRED EMBODIMENT
The aforementioned U.S. Patent No. 5,451,321 to
Matkovich shows a biological fluid processing assembly for
filter biological processes such as blood. An example of
the Matkovich apparatus is illustrated in Fig. 1. The
apparatus has a blood collection bag 30 connected by a
first conduit 31 to a leukocyte depletion device 32. The
leukocyte depletion device 32 is connected by a second
conduit 33 to a blood receiving bag 34. A gas inlet 35
having a cover or cap 36, is provided in fluid
communication with the first conduit 31 downstream of said
collection bag 30, and a gas outlet 37 is provided in
second conduit 33 downstream of the leukocyte depletion
device 32.
In one embodiment of the prior art, a first clamp 38
is placed on first conduit 31 downstream of the blood
collection bag 30 and upstream of the gas inlet 35, and a
second clamp 39 is placed on the second conduit 33
downstream of the gas outlet 37. In a typical operation
the blood collection bag 30 is sterile. and is connected to
the conduit 31 as illustrated. The gas inlet 35 is
comprised of a housing 41 and a porous medium barrier 42
in addition to cover or cap 36. Additional details of the
barrier 42 may be obtained by reference to U.S. Patent No.
5,451,321.
Prior to the start of blood processing, the inlet
clamp 38, the outlet clamp 39, and the gas inlet 35 are
all closed. The blood processing is initiated by opening
the inlet clamp 38, and allowing the blood to drain from
the blood collection bag 30. A column of blood flows
through the first conduit 31 into the leukocyte depletion
device 32 displacing any gas within the blood processing
system. No blood enters the gas inlet device 35 since the
gas inlet is closed. The displaced gas is expelled from
the system through the gas outlet 37 since the second
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clamp 39 is closed. As substantially all the gas is
expelled from the first conduit 31 and the portion of the
second conduit 33 leading to the gas outlet 37, the porous
medium is wetted by the blood, and the blood flow seizes
or stops at the liquiphobic bearer in the gas outlet 37.
Once the gas outlet 37 is wetted, the second or
outlet clamp 39 is opened, and filtered blood flows into
the blood receiving bag 34. The gas outlet 37 need not be
closed prior to opening of the outlet clamp since the gas
outlet is sealed by the wetted.porous medium. Blood flows
from the collapsible blood container or bag 30 through the
leukocyte depletion device 32 and into the blood receiving
bag 34 until equilibrium is reached within the system and
blood ceases to flow. At this point, all of the blood has
not been processed through the leukocyte depletion device
32. The first conduit 31, the filter device 32, and the
second conduit 33 are filled with blood.
Removing the cover or cap 36 from the gas inlet 35
allows gas to enter the processing system and drive the
blood through the leukocyte depletion device 32. However,
since the filter medium 32A within the leukocyte depletion
device 32 is wetted, the flow of blood seizes when gas
fills the upstream chamber of the filter. When the blood
flow seizes, the second or outlet clamp 39 is closed.
It can be seen that, at this point, the downstream
side of the leukocyte depletion device 32, and the entire
second conduit 33 are filled with blood. With ever
increasing need for blood and blood products, those
skilled in the prior art have strived to increase the
recovery of blood, and such a relatively large quantity of
blood being left,in the device of the prior art is no
longer satisfactory.
In order to solve the recovery problems present in
the prior art devices, the open-loop construction shown in
Fig. 2 has been developed. There is shown a biological
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fluid filtration system 44 having a leukocyte depletion
device 45 with a filter medium 46, an inlet 47, and an
outlet 48. The leukocyte depletion device may be such as
the biological fluid filter shown in US Patent No. 6,171,493,
or any other suitable fluid filtration or leukocyte depletion
device.
A blood container 49 is provided upstream from, and
elevated above said leukocyte depletion device 45.' Blood
container 49 is connected to, or in fluid communication
with, said leukocyte depletion device 45 through first
conduit 50.
There is also provided a blood receiving container 52
downstream of said leukocyte depletion device 45.
Leukocyte depletion device 45 is connected to blood
receiving container 52 through second conduit 54. An
upstream gas inlet 56 is provided in fluid communication
with said first conduit 50, and a downstream gas inlet 58
is provided in fluid communication with said leukocyte
depletion device 45, downstream of said filter medium 46.
An inlet clamp 60 and an outlet clamp 61 may be
provided. It should be understood that one or more of
inlet clamp 60 and/or outlet clamp 61 may be provided, and
be well within the scope of the present invention.
Upstream gas inlet 56 may take the form of a vent
line 62 being connected to an upstream gas inlet housing
64. Vent line 62 may have a U-shaped portion 62A to
prevent drawing of gas into biological fluid filtration
system 44 until substantially all of the biological fluid
has drained from the biological fluid container 49. The
other end of vent line 62 should be at a sufficient height
such that it is always positioned above the level of the
fluid in the biological fluid container 49.
Upstream gas inlet housing or vent 64 has an inlet 65
and an outlet 66. Interposed between the inlet 65 and the
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outlet 66 in a sealing relationship is at least one layer
of a porous medium 67. The porous medium may be such as a
bacterial retention medium, a viral retention medium, or
other suitable medium.
5 In a similar manner, the downstream gas inlet 58 may
comprise a second vent line 70 connected to a downstream
gas inlet housing or vent 71 having an inlet 72 and an
outlet 73. A cap or other closure 74 may be used in
connection with the opening and the closing of inlet 72.
10 Interposed in the housing 71, between the inlet 72 and the
outlet 73 is a second porous medium 76. The second porous
medium 76 may also be such as a bacterial retention
medium, a viral retention medium, or other suitable
medium.
As illustrated, upstream gas inlet housing 64 and
downstream gas inlet housing 71 may be provided in a
single novel inlet device 80 having a barrier or wall 81
which prevents fluid communication between the upstream
gas inlet porous medium 67 and the downstream gas inlet
porous medium 76. The upstream medium 67 and the
downstream medium 76 may then be formed of a single sheet.
The upstream gas inlet 56 and the downstream gas
inlet 58 may be placed in any practicable location as long
as they are located such that the blood product being
filtered never contacts the porous medium 67. In the
preferred embodiment illustrated the porous medium 67
contained within the housing 64 is elevated above the
blood container 49, but other locations are well within
the scope of the present invention.
In the method of blood processing embodying the
present invention, the inlet clamp 60 and the outlet clamp
61 are initially closed. The cap or closure 74 covering
the inlet 72 of downstream gas inlet device, housing, or
housing portion 71 is also in place.
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The blood processing is initiated by opening the
inlet clamp 60 and allowing the biological fluid to flow
through the first conduit 50. As the fluid flows past the
junction 50A, some of the fluid will flow into the
upstream gas inlet 56 through vent line 62. A column of
liquid of a predetermined, desired, length (shown as
dimension A in Fig. 2), between the junction 50A and the
bottom of the loop portion of 62A, prevents gas entry into
the system until substantially all of the biological fluid
has been drained from the biological fluid container 49.
The upstream gas vent may be thought of as a
manometer measuring the pressure at the junction 50A. As
the level of fluid within the biological fluid container
49 decreases, thepressure at the junction 50A decreases
and, therefore, the height of the fluid in the vent line
62 decreases. When substantially all of the biological
fluid has drained from the biological fluid container 49,
the atmospheric pressure acting on the column of fluid
within the vent line 62 will cause all of the fluid within
the upstream gas inlet 56 to drain into the conduit 50.
The remaining fluid contained with the,upstream gas inlet
line 62 is drained into the conduit 50 because the
upstream gas inlet is open to atmosphere. Thus, dimension
A in Fig. 2 must be of sufficient distance such that the
above described sequence of events occur. At this point,
the leukocyte depletion device 45 downstream of the filter
medium 46 and the second conduit 54 between the leukocyte
depletion device 45 and the blood receiving container 52,
are all filled with filtered biological fluid.
The filtered biological fluid or blood downstream of
the filter medium 46 in the leukocyte depletion device 45
may now be recovered by opening the cap or closure 74
covering the inlet 72 of downstream gas inlet device,
housing, or housing portion 71. In place of cap 74, a
clamp (not shown) could be used on second vent 70.
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After this step substantially all of the blood
previously unrecovered by the prior art devices is in the
blood receiving container 52. Any gas in the receiving
container 52. and/or second conduit 54 downstream of the
disconnecting point of the blood receiving container 52
may be pushed back up into the second conduit 54 by gently
squeezing the blood receiving container.52, and then the
outlet clamp 61 can be closed.
As is now evident, the construction shown in Fig. 2
provides an easy method of drainage of substantially all
of the biological fluid from the receiving bag 52 through
the leukocyte depletion device 45. In addition, the
biological fluid filtration system 44 in its preferred
embodiment.utilizes only a single housing in the inlet
device 80, and a single layer of porous medium and
substantially all of the filtered biological fluid is
recovered. The system has a lower number of parts, is
easier to manufacture, and recovers more biological fluid
at a lower per unit biological fluid processing cost.
. Alternate embodiments of the construction shown in
Fig. 2.are illustrated in Figs. 3-5, with like numerals
designating corresponding parts in the several views.
Their operation can easily be understood by those skilled
in the art in view of the foregoing description.
A modification of the present invention.utilizing
only the upstream gas inlet 56 and a satellite bag 83 is
shown in Fig. 12. Satellite bag 83 is connected in fluid
communication with blood receiving container 52 by
satellite conduit 84. Satellite clamp 85 opens and closes
satellite conduit 84. In this embodiment of the present
invention, the satellite bag is used to vent the gas
displaced from the receiving c.ontainer 52. The volume_of
the satellite bag 83 should be sufficient to accept all of
the gas displaced. After all the blood has flowed into
the receiving container 52, the container is gently
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squeezed until all of the gas is vented past the satellite
clamp 85, at which time the satellite clamp 85 is,closed.
Referring now to Fig. 6, there is shown a closed loop
biological fluid filtration system 90. As in previous
embodiments of the present invention, there is a leukocyte
depletion device 45 having a filter medium 46, an inlet
47, and an outlet 48. The filter medium 46 is interposed
in a sealing relationship between the inlet 47 and the
outlet 48. The system 90 also includes a blood container
49 connected by first conduit 50 to the inlet 47 of
leukocyte depletion device 45. Inlet clamp 60 is provided
as before.
Provided downstream of the leukocyte depletion device
45 is a blood receiving container 52. A second conduit 54_
is connected between the outlet 48 of the leukocyte
depletion device 45 and the inlet of the blood receiving
container 52. Used in place of the upstream gas inlet 56
and a downstream gas inlet 58 is a by-pass line 91, which
may be opened and closed by by-pass clamp 92. A first end
of the by-pass line 91 is connected in fluid communication
with the blood container 49 proximate the outlet thereof,_
and the other end of the by-pass line 91 is connected in
fluid communication with the blood receiving container 52
proximate the inlet thereof. The loop portion 93 of the
by-pass line 91 is positioned such that when the blood
container 49 is full of blood, the blood will not reach
the loop portion 93 and thus, there can be no flow of
blood through the by-pass line. One such position is
illustrated in Fig. 6 with the loop portion 93 elevated
above the blood container 49.
In place of loop portion 93, a one way check valve or
other device may be used such that a column of gas will
always separate the unfiltered biological fluid upstream
of the filtration device from the filtered biological
fluid downstream of the leukocyte depletion device 45.
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The positioning of the loop portion 93, and the bypass
line 91 may also be varied to accomplish this.
The method of operating the the closed loop
embodiment of the invention differs in several respects
from the method used with the open loop embodiment. As
illustrated in Fig. 6, the additional by-pass clamp 92 is
needed because no gas inlet or gas outlet devices are
provided, as were necessary in the prior art. Prior to
the start of blood processing, the inlet clamp 60 is
closed and the by-pass clamp 92 is open. The blood
processing is initiated by opening the inlet clamp 60 and
allowing blood to drain from the blood container 49
through first conduit_50 into the leukocyte depletion
device 45 and therethrough to the blood receiving
container 52. The blood does not by-pass the leukocyte
depletion device 45 because of the loop portion. 93. of the
by-pass line 91 being elevated to a sufficient height.
The gas within the closed loop biological fluid filtration
system 90 is displaced by the blood flow into the-blood
receiving container 52. As the blood container 49
approaches its nearly empty condition,.the gas stored
within the receiving container 52 automatically flows
through the by-pass line 91 into the blood container 49
and allows substantially all of the blood to be processed
through the leukocyte filtration device 45. It is
important to note that the chamber of the leukocyte
depletion device 45 downstream of the filter media 46 at
this point will be filled with blood, as will the second
conduit 54 between the leukocyte depletion device and the
blood receiving container 52. -If there is any gas left in
the receiving container 52 it may be displaced into the
by-pass line 91 by closing the outlet clamp 61, gently
squeezing the blood receiving container 52 and closing the
by-pass clamp 92. In this embodiment of the invention
comprising the closed loop biological fluid filtration
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system, the chamber downstream of the filter medium 46 in
the leukocyte depletion device 45 is not drained of blood,
nor is second conduct 54. However, the inlet device and
the outlet devices of the prior art are eliminated, and a
5 simplified system is provided.
I Additional modifications of the closed loop
biological fluid filtration system 90 are shown in Figs.
7-11.. Their operation can be understood by those skilled
in the art from the foregoing description.
10 Therefore, by carefully studying the problems present
in prior art biological filtration fluid systems, I have
developed a novel method and apparatus for biological
fluid filtration.
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