U.S. patent application number 09/088231 was filed with the patent office on 2001-12-20 for blood collection systems and methods employing an air venting blood sample tube.
Invention is credited to BLICKHAN, BRYAN J., LYNN, DANIEL.
Application Number | 20010052497 09/088231 |
Document ID | / |
Family ID | 22210159 |
Filed Date | 2001-12-20 |
United States Patent
Application |
20010052497 |
Kind Code |
A1 |
BLICKHAN, BRYAN J. ; et
al. |
December 20, 2001 |
BLOOD COLLECTION SYSTEMS AND METHODS EMPLOYING AN AIR VENTING BLOOD
SAMPLE TUBE
Abstract
Systems and methods for collecting blood substantially free of
residual air and undesired matter also assure that accurate
crossmatching and typing of cellular blood components can be done
prior to transfusion.
Inventors: |
BLICKHAN, BRYAN J.; (ZION,
IL) ; LYNN, DANIEL; (SPRING GROVE, IL) |
Correspondence
Address: |
BAXTER HEALTHCARE CORPORATION
BRADFORD PRICE, FENWAL DIVISION RLP-30
ROUTE 120 AND WILSON ROAD
ROUND LAKE
IL
60073
|
Family ID: |
22210159 |
Appl. No.: |
09/088231 |
Filed: |
June 1, 1998 |
Current U.S.
Class: |
210/669 |
Current CPC
Class: |
A61M 1/0222 20140204;
A61M 1/0231 20140204 |
Class at
Publication: |
210/669 |
International
Class: |
B01D 015/00 |
Claims
We claim:
1. A blood processing assembly comprising a blood receiving
container having first and second ports, a first flow path
including an inlet region for coupling the first flow path in fluid
communication with a blood source container and an outlet region
coupled to the first port, the first flow path including a
separation device positioned between the inlet and outlet regions
that separates undesired matter from blood en route the blood
receiving container, and a second flow path including an entry
region coupled to the second port and not the first port and an
exit region coupled to the inlet region of the first flow path at a
junction, the second flow path including a one-way valve between
the entry region and the exit region that permits fluid flow
through the second flow path, bypassing the separation device, only
from the blood receiving container toward the blood source
container and not vice versa.
2. An assembly according to claim 1 wherein the first flow path
includes a flow control device in the inlet region between the
separation device and the junction.
3. An assembly according to claim 1 wherein the second flow path
includes a flow control device in the exit region between the
one-way valve and the junction.
4. An assembly according to claim 1 wherein the second flow path
comprises a length of tubing carrying at least one identification
marking along its length.
5. An assembly according to claim 4 wherein the tubing can be
sealed to form at least one sealed pocket for containing blood
conveyed from the blood receiving container into the tubing.
6. An assembly according to claim 4 wherein the blood receiving
container carries an identification marking matching the at least
one identification marking carried by the tubing.
7. An assembly according to claim 1 wherein the second flow path
comprise a length of heat sealable tubing.
8. An assembly according to claim 1 wherein the first flow path
comprises a length of heat sealable tubing.
9. An assembly according to claim 1 wherein the second f low path
forms a channel to vent air from the blood receiving container into
the blood source container in response to squeezing the blood
receiving container.
10. An assembly according to claim 1 or 8 wherein the second flow
path forms a channel to receive a blood sample from the blood
receiving container in response to squeezing the container.
11. An assembly according to claim 1 wherein the separation device
comprises a filter for removing leukocytes from blood.
12. An assembly according to claim 1 wherein the inlet region of
the first flow path includes a coupler for joining the inlet region
in fluid communication with the blood source container.
13. An assembly according to claim 1 wherein the inlet region of
the first flow path forms a sterile connection with the blood
source container.
14. An assembly according to claim 1 wherein the inlet region of
the first flow path is integrally connected to the blood source
container.
15. An assembly according to claim 1 and further including
directions for using the assembly according to a method comprising
the steps of (i) conveying blood from the blood source container
through the first flow path and separation device to separate
undesired matter from the blood, forming undesired matter-reduced
blood, (ii) conveying the undesired matter-reduced blood from the
separation device into the blood receiving container, (iii)
squeezing the blood receiving container to vent air from the blood
receiving container through the second flow path into the blood
source container, and (iv) squeezing the blood receiving container
to advance a sample of undesired matter-reduced blood into the
second flow path.
16. An assembly according to claim 15 wherein the directions for
using the assembly further including the step of (v) severing the
outlet region of the first flow path and the exit region of the
second flow path, forming a processed assembly comprising the blood
receiving container holding undesired matter-reduced blood, vented
of air, and the entry region of the second flow path holding the
sample of undesired matter-reduced blood.
17. A method for processing blood using a collection container
having two ports comprising the steps of directing blood through a
separation device to remove undesired matter, directing blood from
the separation device into the collection container only through
the first port, squeezing the collection container to expel
residual air from the collection container through a flow path,
which is coupled to the second port and bypasses the separation
device, the flow path including a one-way valve permitting air flow
only in a direction away from the collection container and not vice
versa, squeezing the collection container to convey a sample of
blood from the collection container into the flow path, the one-way
valve permitting blood flow only in the direction away from the
collection container and not vice versa, and sealing the flow path
to retain the sample of blood in the flow path.
18. A method for processing blood using a collection container
having two ports comprising the steps of directing blood through a
separation device to remove undesired matter, directing blood from
the separation device into the collection container only through
the first port, squeezing the collection container to expel
residual air from the collection container through a flow path,
which is coupled to the second port and bypasses the separation
device, the flow path including a one-way valve permitting air flow
only in a direction away from the collection container and not vice
versa, squeezing the collection container to convey a sample of
blood from the collection container into the flow path without
using a blood tube stripper, the one-way valve permitting blood
flow only in the direction away from the collection container and
not vice versa, and sealing the flow path to retain the sample of
blood in the flow path.
Description
FIELD OF THE INVENTION
[0001] The invention generally relates to blood collection and
processing systems and methods. In a more particular sense, the
invention relates to systems and methods for removing white blood
cells from red blood cells prior to transfusion or long term
storage.
BACKGROUND OF THE INVENTION
[0002] Systems composed of multiple, interconnected plastic bags
have met widespread use and acceptance in the collection,
processing and storage of blood components.
[0003] Before storing red blood cells for later transfusion, it is
believed to be desirable to minimize the presence of impurities or
other materials that may cause undesired side effects in the
recipient. For example, because of possible febrile reactions, it
is generally considered desirable to store red blood cells with a
reduced number of--leukocytes. Filtration is conventionally used to
accomplish leuko-reduction.
[0004] Systems and methods for reducing the number of leukocytes by
filtration in multiple blood bag configurations are described.
e.g., in Stewart U.S. Pat. No. 4,997,577, Stewart et al. U.S. Pat.
No. 5,128,048, Johnson et al U.S. Pat. No. 5,180,504, and Bellotti
et. al. U.S. Pat. No. 5,527,472. In these filtration systems and
methods, a transfer assembly dedicated solely to the filtration of
leukocytes from red blood cells is used. The transfer assembly also
has a second fluid path that bypasses the filtration for the
purpose of transferring liquid or venting air around the separation
device.
[0005] In addition, before transfusing stored cellular blood
components like red blood cells, it is important to assure that the
blood type of the recipient matches the blood type of the donor.
For this reason, conventional blood collection procedures collect
several small aliquots or samples of the donated blood component
for use in crossmatching and typing the donor's blood prior to
transfusion.
[0006] FIG. 1A shows a representative conventional system that
filters leukocytes from red blood cells, vents air from the
filtered cells, and creates segmented aliquots of the filtered
cells for crossmatching and typing purposes. In use, red blood
cells are conveyed from a transfer bag 1 through a leukocyte
reduction filter 2 into a storage bag 3. An in-line clamp C
controls this flow. Once filtration is completed, the storage bag 3
is squeezed to expel air through a bypass line 4 around the filter
2 into the transfer bag 1. An in-line check valve CV permits
one-way fluid flow toward the transfer bag 1, but blocks fluid flow
in the opposite direction toward the storage bag 3. A conventional
heat sealing device (for example, the Hematrons dielectric sealer
sold by Baxter Healthcare Corporation, not shown) forms a hermetic,
snap-apart seal X1 in the tubing just downstream of the filter 2.
The system components upstream of the seal X1 are disconnected and
discarded. As FIG. 1B shows, the remaining tubing 5 (still attached
to the storage bag 3) carries alpha or numeric identification
markings 6 (which may also be machine-readable), which are printed
in a spaced-apart pattern along its length. As FIG. 1A shows, a
label 7 on the storage bag 3 carries the same identification
markings 6. Using a conventional blood tube stripper (also not
shown), the technician displaces residual air from the remaining
tubing 5 into the storage bag 3. Upon removal of the tube stripper,
the air displaced into the storage bag 3 expels filtered cells into
the remaining tubing 5 to occupy the numbered segments 6. As FIG.
1D shows, the sealer is then used to form sealed, snap-apart seals
X2 between the identification markings 6, creating segmented
pockets 8 where the samples of the filtered cells are retained. The
donor-specific label 7 is removed from the transfer bag 1 and
attached to the storage bag 3, to thereby preserve a link between
the transfer bag 1, the storage bag 3, the numbered blood segments
8, and the donor.
[0007] Alternatively, as shown in FIGS. 1A and 1C, the conventional
storage bag 3 can also include an attached tubing segment, or
"pigtail" P, which carries the same identification markings 6
printed in a spaced-apart pattern along its length. Once filtration
and air venting is completed, the technician uses the blood tube
stripper to displace residual air from the pigtail P into the
storage bag 3, which in turn displaces filtered cells into the
pigtail P. The sealer can then be used to form sealed, snap-apart
pockets, as before described, one for each numbered segment, where
the samples of the filtered cells are retained.
[0008] Prior techniques require the technician to perform mutiple,
separate functional steps. First, the technician must vent air from
the storage bag. Then, the technician must pick up and operate a
tube stripper, to expel blood from the storage bag into tubing to
create segmented samples for crossmatching and blood typing.
SUMMARY OF THE INVENTION
[0009] The invention provides more straightforward and convenient
systems and methods to remove undesired matter from blood cells,
which permit air venting and sample expulsion to take place in one
functional step. The invention obviates the need for tube
strippers, thereby simplifying the overall blood manipulation
process. Still, the invention assures that accurate crossmatching
and typing of the blood occurs.
[0010] One aspect of the invention provides a blood processing
assembly comprising a blood receiving container having first and
second ports. A first flow path is included, which has an inlet
region for coupling the first flow path in fluid communication with
a blood source container and an outlet region coupled to the first
port. The first flow path includes a separation device positioned
between the inlet and outlet regions that separates undesired
matter from blood en route the blood receiving container. A second
flow path is also included, which has an entry region coupled to
the second port, and not the first port, and an exit region coupled
to the inlet region of the first flow path at a junction. The
second flow path includes a one-way valve between the entry region
and the exit region. The one-way valve permits fluid flow through
the second flow path, bypassing the separation device, only from
the blood receiving container toward the blood source container and
not vice versa.
[0011] Another aspect of the invention provides a method of using
the assembly. The method directs blood through the first flow path
and separation device to remove undesired matter. The blood is
collected in the blood receiving container after passage through
the separation device. The method squeezes the blood receiving
container to expel residual air from the blood receiving container
through the second flow path. The one-way valve permits air flow
only in a direction away from the blood receiving container, and
not vice versa. The method squeezes the blood receiving container
to convey a sample of blood from the collection container into the
second flow path. Again, the one-way valve permits blood flow only
in the direction away from the blood receiving container, and not
vice versa. The method seals the second flow path to retain the
sample of blood in the second flow path.
[0012] By virtue of the above described structure and method of
use, a sample of blood from the blood receiving container can be
transferred into the second flow path simply by squeezing the blood
receiving container, and coincident with air venting. There is no
need for separate air venting and blood sample collecting steps,
and there is no need for a tube stripper.
[0013] In a preferred embodiment, the separation device removes
leukocytes from blood.
[0014] Other features and advantages of the invention will become
apparent upon review of the following description, drawings, and
appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1A is a schematic view of a conventional blood
collection system to remove leukocytes from red blood cells;
[0016] FIGS. 1B and 1C are enlarged views of tubes associated with
the system shown in FIG. 1A, which, in use, retain a sample of the
processed blood, showing the identification markings used to link
the blood samples to the stored blood product following
leuko-reduction;
[0017] Fig. 1D is an enlarged view of a portion of the prior art
system shown in FIG. 1A, showing the tube shown in FIG. 1B after
having been segmented by heat sealing into blood sample-retaining
pockets;
[0018] FIG. 2 is a schematic view of a blood collection system
having a blood collection assembly and a blood filtration assembly,
which embodies features of the invention;
[0019] FIG. 3 is a schematic view of the blood collection assembly
shown in FIG. 2, after whole blood collected in the assembly has
been centrifugally processed into red blood cells containing
leukocytes, retained in a primary bag, and platelet-rich plasma,
retained in a transfer bag;
[0020] FIG. 4 is a schematic view showing the connection of the
blood filtration assembly to the primary bag of the blood
collection assembly for the purpose of removing leukocytes from the
red blood cells while being conveyed to a storage bag;
[0021] FIG. 5 is a schematic view of the connected blood filtration
assembly and the blood collection assembly after the red blood
cells have been filtered, showing the venting of residual air from
the storage bag into the primary bag through a tube segment that
bypasses the filter;
[0022] FIG. 6A is a schematic view of the connected blood
filtration assembly and the blood collection assembly after
residual air has been vented from the storage bag, showing the
advancement of filtered red blood cells into the same tube segment
used to vent air from the storage bag without the use of a tube
stripper;
[0023] FIG. 6B is an enlarged schematic view of the tube segment
shown in FIG. 6A, into which filtered red blood cells have been
advanced while venting air from the storage bag, showing the
identification markings printed on the tube segment;
[0024] FIG. 7A is a schematic view of the storage bag and attached
tube segment, after having been separated from the rest of the
system for storage of the red blood cells;
[0025] FIG. 7B is an enlarged schematic view of the tube segment
attached to the storage bag shown in FIG. 7A, showing the tube
segment after having been segmented by heat sealing into blood
sample-retaining pockets; and
[0026] FIG. 8 shows a schematic view of another blood collection
system having an integrally attached a blood filtration assembly,
which embodies features of the invention.
[0027] The invention may be embodied in several forms without
departing from its spirit or essential characteristics. The scope
of the invention is defined in the appended claims, rather than in
the specific description preceding them. All embodiments that fall
within the meaning and range of equivalency of the claims are
therefore intended to be embraced by the claims.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0028] A blood collection system 10, which embodies features of the
invention, is shown in FIG. 2. The system 10 comprises a blood
collection and processing assembly 12 and a filtration assembly
14.
[0029] The blood collection and processing assembly 12 comprises a
multiple blood bag system having a primary bag or container 16 and
one or more integrally attached transfer bags or containers 18 and
26. In use, the primary bag 16 (which is typically also called a
donor bag) receives whole blood from a donor through integrally
attached donor tubing 20 by means of a phlebotomy needle 22. A
suitable anticoagulant A (e.g., CPD or ACD) is contained in the
primary bag 16.
[0030] The transfer bag 18 is attached to the primary bag 16 by
integrally attached transfer tubing 30. The transfer bag 18 is
intended to receive the platelet-rich plasma blood component for
processing. The transfer bag 26 contains a suitable storage
solution S for red blood cells. The storage solution S will
ultimately be conveyed from the transfer bag 26 to the primary bag
16 during the course of blood processing. A representative storage
solution S is disclosed in Grode et al U.S. Pat. No. 4,267,269. A
conventional in-line frangible cannula 24 and in-line clamps 25
control fluid flow through the tubing 30. 18 among the bags 16, 18,
and 26.
[0031] All of the bags 16, 18, and 26 and tubing 30 associated with
the processing assembly 12 can be made from conventional approved
medical grade plastic materials, such as polyvinyl chloride
plasticized with di-2-ethylhexylphthalate (DEHP). The blood
collection assembly 12, once sterilized, constitutes a sterile,
"closed" system, as judged by the applicable standards in the
United States.
[0032] Preferably (as FIG. 2 shows), before whole blood is
collected, a removable donor-specific label 25 is attached to the
primary blood bag 16. The label 25 carries a unique identification
number assigned to the particular donor at the time of
donation.
[0033] Whole blood is collected from the donor in the primary bag
16. The whole blood is separated by centrifugation in the primary
bag 16 into red blood cells and platelet-rich plasma. In the
process of centrifugally separating these components, a layer rich
in leukocytes forms between the red blood cells and the
platelet-rich plasma.
[0034] The platelet-rich plasma is transferred by conventional
techniques into the transfer bag 18, leaving the red blood cells
(designated RBC) and leukocytes (designated LC) in the primary bag
16. The red cell storage solution S is then transferred from the
bag 26 to the primary bag 16 through the transfer tubing 30. As
FIG. 3 shows, the donor tubing 20 and the bags 18 and 26 are
detached using snap apart seals "x" formed by a conventional
dielectric sealing device, as previously described.
[0035] The platelet-rich plasma can undergo subsequent centrifugal
separation within the first transfer bag 18 into platelet
concentrate and platelet-poor plasma. An additional preattached
transfer bag (not shown) can be included to receive the
platelet-poor plasma.
[0036] As FIG. 2 shows, the filtration assembly 14 comprises an
initially separate subassembly not joined to the blood processing
assembly 12. The entire filtration assembly 14 can be provided in a
"dry" condition, free of any fluids, storage mediums, and the like
(except for any entrapped air).
[0037] The filtration assembly 14 includes a storage bag 34 and an
associated main tube path 36. The tube path 36 further includes an
inline device 40 for separating undesired matter from blood
cells.
[0038] The filtration assembly 14 also includes an integrally
attached tube segment 32. The far end of the tube segment 32 joins
the main tube path 36 upstream of the separation device 40, via a
conventional Y-coupler 28.
[0039] The storage bag 34, main tube path 36, and the tube segment
32 can all made of low cost medical grade plastic materials, such
as polyvinyl chloride plasticized with DEHP.
[0040] In the illustrated embodiment, the filtration assembly 14
serves to remove undesired matter from blood cells by filtration.
For this reason, the assembly 14 and the device 40 will be referred
to as a "filtration" assembly and device. It should be appreciated,
however, that separation can occur by various centrifugal and
non-centrifugal techniques, and not merely "filtration" in the
technical sense. Separation can occur by absorption, columns,
chemical, electrical, and electromagnetic means. The term
"filtration assembly" or "filtration device" is broadly used in
this specification encompass all of these separation techniques as
well.
[0041] It should be appreciated that the filtration assembly 14 can
be used to remove all types of undesired materials from different
types of blood cells, depending upon its particular construction.
In the illustrated embodiment, the filtration assembly 14 is
intended to remove leukocytes from the red blood cells prior to
storage. Still, it should be appreciated the features of the
assembly 14 and its method of use can be used for separating matter
from other blood products, such as plasma or platelets or whole
blood itself.
[0042] In this arrangement, the filtration device 40 includes a
housing 42 containing a conventional filtration medium 44 suited
for the removal of leukocytes from red blood cells. The filtration
medium 44 can include cotton, wool, cellulose acetate or another
synthetic fiber like polyester.
[0043] A clamp 38, e.g., a conventional roller clamp, regulates
flow through the main tube path 36 into the storage bag 34 via the
filtration device 40.
[0044] A one-way check valve 48 controls fluid flow through the
tube segment 32. The valve 48 does not allow passage of fluid
(liquid or air) in the direction of the storage bag 34. However,
the valve 48 does allow passage of fluid (liquid and air) in the
opposite direction, away from the storage bag 34.
[0045] If desired, another conventional clamp 46 can be provided to
further regulate flow through the tube segment 32 upstream of the
valve 48.
[0046] A connection assembly 50 is associated with the initially
separate blood collection and filtration assemblies 12 and 14. The
connection assembly 50 permits selective attachment of the
filtration assembly 14 to the blood collection assembly 12, as FIG.
4 shows. The technician closes both clamps 38 and 46 before
attachment of the assemblies 12 and 14.
[0047] In the illustrated and preferred embodiment, both assemblies
12 and 14, once sterilized, comprise sterile, "closed" systems, as
judged by the applicable United States standards. In this
arrangement, the connection assembly 50 serves to attach the donor
bag 16 to the filtration assembly 14 in a manner that preserves the
sterile integrity of the closed systems 12 and 14.
[0048] The connection assembly 50 can be variously constructed. It
can comprise the conventional sterile connecting system disclosed
in Spencer U.S. Pat. No. 4,412,835 (not shown), which is
incorporated herein by reference. In this arrangement (which is
shown in FIG. 4), the system forms a molten seal between the
transfer tube 30 of the primary bag 16 (after having been separated
from the transfer bags 18 and 26, as FIG. 3 shows) with the end 52
of the tube path 36 of the filtration assembly 14. Once cooled, a
sterile weld 64 is formed. In an alternate arrangement (not shown),
the connection assembly 48 can comprises two mating sterile
connection devices of the type shown in Granzow et al U.S. Pat.
Nos. 4,157,723 and 4,265,280, which are incorporated herein by
reference. In either case, the attachment is made without otherwise
opening the assemblies 12 and 14 to communication with the
atmosphere. As a result, the filtered cells can be stored for the
maximum allowable dating period.
[0049] The end 52 of the tube path 36 can also carry a conventional
blood spike 54. Instead of forming a sterile weld 64, the
technician can insert the blood spike 54 in conventional fashion
into a port 56 of the primary bag 16, thereby joining the two
assemblies 12 and 14 together. This attachment technique, however,
opens the assemblies 12 and 14 to communication to the atmosphere.
As a result, the filtered cells must be transfused within 24
hours.
[0050] Once attachment of the assemblies 12 and 14 is made, the
donor bag 16 is gently squeezed to mix the unfiltered red blood
cells. The donor bag 16 is lifted above the storage bag 34 (as FIG.
4 shows), and the flow clamp 38 is opened. The red blood cells
(designated RBC) are conveyed by gravity flow from the donor bag 16
through the tube path 36 and filtration device 40 and into the
transfer bag 34. The closed clamp 46 or the check valve 48 (in the
absence of or the opening of the clamp 46) prevents flow through
the tube segment 32.
[0051] In the process, the leukocytes are removed by the filtration
device 40 from the blood cells. Once the red blood cells are
transferred, the donor-specific label 25 is removed from the
primary bag 16 and applied to the storage bag 34, to preserve the
link to the donor.
[0052] As FIG. 5 shows, once the filtration is completed, the clamp
46 is opened. The storage bag 34 is squeezed gently. The squeezing
expels residual air (designated RA in FIG. 5) from the storage bag
34 through the tube segment 32 and into the primary bag 16. The
tube segment 32 thereby provides an air venting path around the
filtration device 40. The check valve 48 prevents back flow of air
and other fluid toward the storage bag 34.
[0053] As FIGS. 6A and 6B show, as residual air RA is removed from
the storage bag 34, the same squeezing action will displace
filtered red blood cells (designated FRBC) from the storage bag 34
into the tube segment 32. The filtered red blood cells FRBC from
the bag 34 fill the tube segment 32. The check valve 48 prevents
back flow of filtered red blood cells FRBC toward the storage bag,
retaining the samples in the tube segment 32.
[0054] As FIG. 6B shows, the tube segment 32 carries alpha or
numeric identification markings 58 printed in a spaced-apart series
along its length. The markings 58 can also be formatted to be
machine readable. A label 60 on the storage bag 34 also carries the
same identification marking 58, which can also be formatted to be
machine readable.
[0055] As FIG. 7A shows, when the desired volume of filtered cells
occupies the marked tube segment 32, the technician employs the
dielectric tube sealer previously described to form snap-apart
seals "x" in the tube path 36 downstream of the filter 40, as well
as in the marked tube segment 32 above the uppermost segment
marking 58, which is preferably located near and downstream of the
check valve 48. This frees the filter 40, associated dependent
upstream tube path 36 and tube segment 32, and the attached primary
bag 16, which is now empty, except for the residual air RA. These
detached components are discarded as a unit.
[0056] As FIG. 7B shows, the technician uses the dielectric sealer
to form sealed, snap-apart pockets 62 along the length of the tube
segment 32, which is still attached to the storage bag 34. The
pockets 62 retain discrete samples of the filtered cells. The tube
segment 32 thereby serves, not only as an air venting path around
the filtration device 40, but also as a segmented blood sample tube
attached to the storage bag 34. Unlike prior segmented sample
tubes, the tube segment 32 can be filled with blood samples by
squeezing the storage bag 34, and without need of a conventional
tube stripping device.
[0057] The resulting fully processed assembly 80 (shown in FIG. 7A)
comprises the air-vented storage bag 34, to which the tube segment
32 with sealed pockets 62 retaining the samples of the donor's
filtered blood is secured. The storage bag 34 also carries the
donor-specific label 25 and linking sample label 60.
[0058] The red blood cells, now substantially reduced of
leukocytes, are stored in the air-vented storage bag 34. The
attached sample pockets 62 of the filtered blood can be separated
from the tube segment 32 when desired, and can be analyzed at a
convenient time prior to transfusion for crossmatching and typing
purposes.
[0059] The invention assures direct traceability between a
leukocyte-reduced blood product for transfusion and the donor from
whom the blood is obtained.
[0060] In the illustrated embodiment (see FIG. 2), the system 10
includes directions 66 for using the system 10 in the manner above
described.
[0061] The foregoing embodiment shows the features of the invention
in the context of a filtration assembly 14, which is, during use,
coupled to a processing assembly 12 to filter leukocytes from red
blood cells. The invention, of course, can be used in the
processing of other kinds of blood components and in association
with other blood collection system configurations.
[0062] For example, as FIG. 8 shows, an integral blood processing
system 68 can include a whole blood collection bag 70 (containing
an anticoagulant A) to which a filtration assembly 72 embodying the
features of the invention is integrally attached. The assembly 72
includes a transfer bag 74 to which the main tube path 36, the in
line filter device 40, and tube segment 32 are coupled in the same
manner shown in FIG. 2. The tube segment 32 also includes the
one-way valve 48, as also previously described. Additional transfer
bags 18 and 26 are integrally attached to the transfer bag 74, in
the same manner the bags 18 and 26 are integrally attached to the
primary bag 16 in FIG. 2. Like the primary bag 16 shown in FIG. 2,
the whole blood collection bag 70 in FIG. 8 includes a donor tube
20.
[0063] In use, a unit of whole blood is collected in the bag 70,
where it is mixed with anticoagulant A. After the donor tube 20 is
disconnected, whole blood is transferred from the bag 70 through
the tube path 36 and filter device 40, into the transfer bag 74. In
this arrangement, the filter device 40 removes leukocytes from
whole blood. In the same manner described in connection with the
assembly 14, the transfer bag 74 is squeezed to vent residual air
through the tube segment 32 into the collection bag 70. Squeezing
of the transfer bag 74 conveys a sample of the filtered whole blood
into the tube segment 32. The tube segment 32 and tube path 36 are
sealed, and the collection bag 70 is disconnected. Sample segments
are formed along the tube 36 still attached to the transfer bag 74,
in the manner already described. This leaves the transfer bag 74,
sample tube segment 32, and transfer bags 18 and 26 remaining as an
integrated assembly.
[0064] The filtered whole blood is thereafter centrifugally
separated in the transfer bag 74 into red blood cells and
platelet-rich plasma. The platelet-rich plasma is expressed into
the transfer bag 18 for storage or further processing. The solution
S is added to the red blood cells remaining in the transfer bag 74,
which becomes the storage container for the red blood cells. The
blood samples of the filtered whole blood can be separated from the
tube segment 32 when desired, and can be analyzed at a convenient
time prior to transfusion for crossmatching and typing
purposes.
[0065] Various features of the invention are set forth in the
following claims.
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