U.S. patent application number 12/392769 was filed with the patent office on 2009-08-06 for blood processing systems and methods that employ an in-line flexible leukofilter.
This patent application is currently assigned to Baxter International Inc.. Invention is credited to Michael J Kast, Kelly B. Smith, Mark R. Vandlik, Rohit Vishnoi, Tom Westberg.
Application Number | 20090194489 12/392769 |
Document ID | / |
Family ID | 25524526 |
Filed Date | 2009-08-06 |
United States Patent
Application |
20090194489 |
Kind Code |
A1 |
Vandlik; Mark R. ; et
al. |
August 6, 2009 |
Blood Processing Systems And Methods That Employ An In-Line
Flexible Leukofilter
Abstract
Systems and methods separate pump the blood cells through an
in-line leukofilter to a blood cell storage container. The
leukofilter has a filtration medium enclosed within a flexile
housing. The systems and methods can employ a fixture to restrain
expansion of the flexible filter housing during operation of the
pump.
Inventors: |
Vandlik; Mark R.; (Hawthorn
Woods, IL) ; Kast; Michael J; (Evanston, IL) ;
Smith; Kelly B.; (Stroudsburg, PA) ; Westberg;
Tom; (Gurnee, IL) ; Vishnoi; Rohit;
(Deerfield, IL) |
Correspondence
Address: |
BAXTER HEALTHCARE CORPORATION
ONE BAXTER PARKWAY, DF2-2E
DEERFIELD
IL
60015
US
|
Assignee: |
Baxter International Inc.
Deerfield
IL
|
Family ID: |
25524526 |
Appl. No.: |
12/392769 |
Filed: |
February 25, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10765498 |
Jan 26, 2004 |
7517333 |
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12392769 |
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09976833 |
Oct 13, 2001 |
6709412 |
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10765498 |
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09389504 |
Sep 3, 1999 |
7041076 |
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09976833 |
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Current U.S.
Class: |
210/808 ;
210/321.6; 210/416.1 |
Current CPC
Class: |
A61M 2205/331 20130101;
A61M 2205/128 20130101; A61M 1/30 20130101; A61M 60/43 20210101;
A61M 2205/12 20130101; A61M 60/268 20210101; A61M 1/3693 20130101;
A61M 1/0218 20140204; A61M 1/3636 20140204; A61M 1/3696 20140204;
A61M 1/302 20140204; A61M 1/303 20140204; A61M 1/0209 20130101;
A61M 1/308 20140204; A61M 60/113 20210101; A61M 1/3633 20130101;
A61M 2205/3393 20130101 |
Class at
Publication: |
210/808 ;
210/416.1; 210/321.6 |
International
Class: |
A61M 1/36 20060101
A61M001/36; B01D 61/30 20060101 B01D061/30 |
Claims
1-8. (canceled)
9. A blood processing system comprising a blood processing set
including a source of blood cells, and a blood component collection
flow channel coupled to the source of blood cells including a blood
cell storage container and an in-line filter to remove leukocytes
from the blood cells before entering the blood cell storage
container, the in-line filter including a leukocyte removal filter
medium and first and second flexible housings, wherein the flexible
housings are comprised of DEHP-free plastic material, and a pump
station adapted to be placed into communication with the blood
component collection flow channel to pump blood into the blood cell
storage container through the in-line filter.
10. The blood processing system of claim 9 wherein said leukocyte
removal filter medium comprises a plurality of layers.
11. The blood processing system of claim 9 wherein said leukocyte
removal filter medium comprises a leukocyte-exclusion filter medium
including a membrane.
12. The blood processing system of claim 9 wherein said leukocyte
removal filter medium comprises a depth filtration filter
comprising a fibrous filter medium.
13. In a method of filtering a liquid using a filter comprising a
flexible housing having an inlet port and outlet port for the
liquid and a sheet-like filter element for removing undesired
components from the liquid, with the inlet port being separated
from the outlet port by the filter element, a method characterized
by maintaining the pressure at the outlet side of the filter at a
positive pressure above atmospheric pressure by controlling a feed
rate per unit time of a feed pump installed in an upstream flow
channel of the filter.
14. The method according to claim 13, wherein the filter does not
comprise a spacer for securing a flow channel at the outlet side of
the filter.
15. The method according to claim 13 or claim 14 wherein a filter
of which the outlet side flexible housing has not been processed to
provide irregularity as a spacer for securing a flow channel at the
filter outlet side and/or a filter in which a tube is not inserted
between the outlet side flexible housing and the sheet-like filter
as a spacer for securing a flow channel at the filter outlet side
are/is used.
16. The method according to claim 13, wherein the liquid to be
filtered is blood.
17. The method according to claim 14, wherein the liquid to be
filtered is blood.
18. The method according to claim 15, wherein the liquid to be
filtered is blood.
19. The method according to claim 16, wherein the liquid to be
filtered is blood.
20. The method according to claim 17, wherein the filter is used
for removal of leukocytes.
21. The method according to claim 18, wherein the filter is used
for removal of leukocytes.
22. In a filtering system for a liquid comprising a filter
comprising a flexible housing having an inlet port and outlet port
for the liquid, a sheet-like filter element for removing undesired
components from the liquid, with the liquid inlet port and the
outlet port separated from each other by the filter element, an
upstream side flow channel connected to the filter inlet port, a
filtered liquid recovery bag, a downstream side flow channel
connecting the filter outlet port with the recovery bag, and a feed
pump installed in the upstream side flow channel, a filtering
system wherein the feed rate per unit time of a feed pump installed
in an upstream flow channel of the filter can be controlled so that
the pressure at the outlet side of the filter is maintained at a
positive pressure above atmospheric pressure.
23. The system according to claim 22 comprising the filter without
a spacer for securing a flow channel at the outlet side of the
filter.
24. The system according to claim 22 or claim 23, wherein a filter
of which the outlet side flexible housing has not been processed to
provide irregularity as a spacer for securing a flow channel at the
filter outlet port and/or a filter in which a tube is not inserted
between the outlet side flexible housing and the sheet-like filter
as a spacer for securing a flow channel at the filter outlet side
are/is used.
25. The system according to claim 22, wherein the liquid to be
filtered is blood.
26. The system according to claim 23, wherein the liquid to be
filtered is blood.
27. The system according to claim 24, wherein the liquid to be
filtered is blood.
28. The system according to claim 25, wherein the filter is used
for removal of leukocytes.
29. The system according to claim 26, wherein the filter is used
for removal of leukocytes.
30. The system according to claim 27, wherein the filter is used
for removal of leukocytes.
31. A liquid filtering method using the system according to claim
22.
32. A liquid filtering method using the system according to claim
23.
33. A liquid filtering method using the system according to claim
24.
34. A liquid filtering method using the system according to claim
25.
35. A liquid filtering method using the system according to claim
26.
36. A liquid filtering method using the system according to claim
27.
37. A liquid filtering method using the system according to claim
28.
38. A liquid filtering method using the system according to claim
29.
39. A liquid filtering method using the system according to claim
30.
40. In a method of filtering blood or blood components using a
filter comprising a flexible housing having an inlet port and
outlet port, said inlet port being separated from the outlet port
by a sheet-like filter element, said sheet-like filter element
removing undesired elements from the blood, the method including:
connecting the inlet port to a source of blood or blood components;
connecting the outlet port to a container; pumping the blood from
the source to the filter by a pump station communicating with a
blood or blood component flow channel; adjusting at least one
filtration parameter so that a pressure at an outlet side of the
filter is above atmospheric pressure; maintaining a pressure at the
outlet side of the filter above atmospheric pressure throughout
filtration by adjusting said at least one filtration parameter; and
collecting filtered blood or blood components in the container.
41. The method according to claim 40 wherein the pressure at the
outlet side of the filter is maintained above atmospheric pressure
by controlling a feed rate per unit time of a feed pump installed
in an upstream flow channel of the filter.
42. The method according to claim 40 wherein the pressure at the
outlet side of the filter is maintained above atmospheric pressure
by restraining expansion of the inlet side flexible housing and the
outlet side flexible housing by contacting an outer surface of each
of said flexible housings with a separate restraining structure to
restrain the outward expansion of said flexible housings under
pressure applied during operation of a feed pump.
43. The method according to claim 40, wherein the filter does not
comprise a spacer for securing a flow channel at the outlet side of
the filter.
44. The method according to claim 40 wherein a filter of which the
outlet side flexible housing has not been processed to provide
irregularity as a spacer for securing a flow channel at the filter
outlet side and/or a filter in which a tube is not inserted between
the outlet side flexible housing and the sheet-like filter as a
spacer for securing a flow channel at the filter outlet side are/is
used.
45. The method according to claim 40, wherein the filter is used
for removal of leukocytes.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of co-pending U.S.
application Ser. No. 09/976,833, filed Oct. 13, 2001, and entitled
Blood Separation Systems and Methods that Employ an In-Line
Leukofilter Mounted in a Restraining Fixture," which is a
continuation-in-part of U.S. patent application Ser. No.
09/389,504, filed Sep. 3, 1999, and entitled "Blood Separation
Systems and Methods Using a Multiple Function Pump Station to
Perform Different On-Line Processing Tasks," which is incorporated
herein by reference.
FIELD OF THE INVENTION
[0002] This invention relates to systems and methods for processing
and collecting blood, blood constituents, or other suspensions of
cellular material.
BACKGROUND OF THE INVENTION
[0003] Today people routinely separate whole blood, usually by
centrifugation, into its various therapeutic components, such as
red blood cells, platelets, and plasma.
[0004] Conventional blood processing methods use durable centrifuge
equipment in association with single use, sterile processing
systems, typically made of plastic. The operator loads the
disposable systems upon the centrifuge before processing and
removes them afterwards.
[0005] Conventional blood centrifuges are of a size that does not
permit easy transport between collection sites. Furthermore,
loading and unloading operations can sometimes be time consuming
and tedious.
[0006] In addition, a need exists for further improved systems and
methods for collecting blood components in a way that lends itself
to use in high volume, on line blood collection environments, where
higher yields of critically needed cellular blood components, like
plasma, red blood cells, and platelets, can be realized in
reasonable short processing times.
[0007] The operational and performance demands upon such fluid
processing systems become more complex and sophisticated, even as
the demand for smaller and more portable systems intensifies. The
need therefore exists for automated blood processing controllers
that can gather and generate more detailed information and control
signals to aid the operator in maximizing processing and separation
efficiencies.
SUMMARY OF THE INVENTION
[0008] The invention provides systems and methods for processing
blood and blood constituents that lend themselves to portable,
flexible processing platforms equipped with straightforward and
accurate control functions.
[0009] One aspect of the invention provides blood processing
systems and methods comprising a blood processing set that includes
a source of blood cells and a blood component collection flow
channel coupled to the source of blood cells. The blood component
collection flow channel includes a blood cell storage container and
an in-line filter to remove leukocytes from the blood cells before
entering the blood cell storage container. The in-line filter
including a fibrous filter medium, first and second flexible
housings, and a unitary, continuous peripheral seal. The peripheral
seal is characterized by being formed by application of pressure
and radio-frequency heating in a single process, to join the first
and second flexible housings to each other, as well as join the
fibrous filtration medium to the first and second flexible
housings. The blood processing system further includes a pump
station adapted to be placed into communication with the blood
component collection flow channel to pump blood into the blood cell
storage container through the in-line filter.
[0010] In one embodiment, the blood processing system further
includes a fixture to restrain expansion of the first and second
filter housings as a result of pressure applied during operation of
the pump station.
[0011] In one embodiment, the source of blood cells includes a
donor flow channel including a blood separation device to separate
blood cells from donor whole blood. Other features and advantages
of the inventions are set forth in the following specification and
attached drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a perspective view of a fluid processing system
that embodies features of the invention, with the doors to the
centrifuge station and pump and valve station being shown open to
accommodate mounting of a fluid processing set;
[0013] FIG. 2 is a perspective view of the system shown in FIG. 1,
with the doors to the centrifuge station and pump and valve station
being shown closed as they would be during fluid processing
operations;
[0014] FIG. 3 is a schematic view of a representative blood
processing circuit formed by the fluid processing set shown in
FIGS. 1 and 2;
[0015] FIG. 4 is a perspective view of a blood processing chamber
and associated fluid conveying umbilicus that form a part of the
fluid processing set shown in FIGS. 1 and 2;
[0016] FIG. 5 is an exploded top perspective view of the of a
two-part molded centrifugal blood processing container, which can
form a part of the fluid processing set used in association with
the device shown in FIGS. 1 and 2;
[0017] FIG. 6 is a bottom perspective view of the molded processing
container shown in FIG. 5;
[0018] FIG. 7 is a side section view of the molded processing
container shown in FIG. 5, after connection of an umbilicus;
[0019] FIG. 8 is a side section view of a three-part molded
centrifugal blood processing container which can form a part of the
fluid processing set used in association with the device shown in
FIGS. 1 and 2;
[0020] FIG. 9 is a top view of the molded processing container
shown in FIG. 5, showing certain details of the separation
channel;
[0021] FIG. 10 is an exploded perspective view of the centrifuge
station and associated centrifuge assembly of the device shown in
FIGS. 1 and 2;
[0022] FIG. 11 is an enlarged exploded perspective view of the
centrifuge assembly shown in FIG. 10;
[0023] FIG. 12 is a perspective view of the centrifuge assembly
fully assembled and housed in the centrifuge station of the device
shown in FIGS. 1 and 2, with the blood processing chamber and
associated umbilicus also mounted on the centrifuge assembly for
use;
[0024] FIG. 13 is a perspective view of the rotor plate that forms
a part of the centrifuge assembly shown in FIGS. 10 to 12, showing
the latch assembly which releasably secures the processing chamber
to the centrifuge assembly, the latch assembly being shown in its
chamber retaining position;
[0025] FIG. 14 is a side section view of the rotor plate shown in
FIG. 13, showing the components of the latching assembly as
positioned when the latch assembly is in its chamber retaining
position;
[0026] FIG. 15 is a side section view of the rotor plate shown in
FIG. 13, showing the components of the latching assembly as
positioned when the latch assembly is in its chamber releasing
position;
[0027] FIGS. 16 to 18 are a series of perspective view of the
centrifuge, station of the device shown in FIGS. 1 and 2, showing
the sequence of loading the processing chamber and associated
umbilicus on the centrifuge assembly prior to use;
[0028] FIGS. 19 to 22 are a series of perspective view of the
centrifuge station of the device shown in FIGS. 1 and 2, after
loading the processing chamber and associated umbilicus on the
centrifuge assembly, showing at ninety degree intervals the travel
of the umbilicus to impart rotation to the processing chamber, as
driven and restrained by umbilicus support members carried by the
yoke;
[0029] FIG. 23 is a schematic view of a fluid processing circuit of
the type shown in FIG. 3, showing certain details of the
arrangement of pumps that convey blood and fluid through the
circuit;
[0030] FIGS. 24A and 24B are perspective views of a leukofilter
that can form a part of the fluid process circuit shown in FIGS. 3
and 23, the leukofilter comprising a filter media enclosed between
two flexible sheets of plastic material, FIG. 24A showing the
leukofilter in an exploded view and FIG. 24B showing the
leukofilter in an assembled view;
[0031] FIGS. 25A and 25B are perspective views of the leukofilter
shown in FIG. 24B in association with a fixture that retains the
leukofilter during use, FIG. 25A showing the leukofilter being
inserted into an opened fixture and FIG. 25B showing the
leukofilter retained for use within a closed fixture;
[0032] FIG. 26 is a perspective view of a device of a type of shown
in FIGS. 1 and 2, with the lid of the device closed to also reveal
the location of various components and a leukofilter holder carried
on the exterior of the lid;
[0033] FIG. 27 is a partial perspective view of a side of the base
of a device of a type shown in FIGS. 1 and 2, showing a holder for
supporting the leukofilter retaining fixture shown in FIGS. 25A and
25B during fluid processing operations;
[0034] FIG. 28 is a view of one side of the leukofilter retaining
fixture of a type shown in FIGS. 25A and 25B, showing a mounting
bracket that can be used to secure the leukofilter either to the
lid-mounted receptacle shown in FIG. 26 or the base-mounted holder
shown in FIG. 27; and
[0035] FIG. 29 is an exploded perspective view of a cassette, which
can form a part of the processing set used in association with the
processing device shown in FIGS. 1 and 2, and the pump and valve
station on the processing device, which receives the cassette for
use.
[0036] 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
[0037] FIG. 1 shows a fluid processing system 10 that embodies the
features of the invention. The system 10 can be used for processing
various fluids.
[0038] The system 10 is particularly well suited for processing
whole blood and other suspensions of biological cellular materials.
Accordingly, the illustrated embodiment shows the system 10 used
for this purpose.
I. System Overview
[0039] The system 10 includes three principal components. These
are: (i) a liquid and blood flow set 12 (shown schematically in
FIG. 3); (ii) a blood processing device 14 (see FIGS. 1 and 2),
which interacts with the flow set 12 to cause separation and
collection of one or more blood components; and (iii) a controller
16 carried on board the device 14, which governs the interaction to
perform a blood processing and collection procedure selected by the
operator.
[0040] A. The Processing Device and Controller
[0041] The blood processing device 14 and controller 16 are
intended to be durable items capable of long term use. In the
illustrated and preferred embodiment, the blood processing device
14 and controller 16 are mounted inside a portable housing or case
36. The case 36 presents a compact footprint, suited for set up and
operation upon a table top or other relatively small surface. The
case 36 is also intended to be transported easily to a collection
site.
[0042] The case 36 includes a base 38 and a hinged lid 40, which
opens for use (as FIG. 1 shows). In use, the base 38 is intended to
rest in a generally horizontal support surface. The lid 40 also
closes for transport (see FIG. 26).
[0043] The case 36 can be formed into a desired configuration,
e.g., by molding. The case 36 is preferably made from a
lightweight, yet durable, plastic material.
[0044] The controller 16 carries out process control and monitoring
functions for the system 10. The controller 16 comprises a main
processing unit (MPU), which can comprise, e.g., a Pentium.TM. type
microprocessor made by Intel Corporation, although other types of
conventional microprocessors can be used. The MPU can be mounted
inside the lid 40 of the case 36.
[0045] Preferably, the controller 16 also includes an interactive
user interface 260, which allows the operator to view and
comprehend information regarding the operation of the system 10. In
the illustrated embodiment, the interface 260 includes an interface
screen carried in the lid 40, which displays information for
viewing by the operator in alpha.quadrature.numeric format and as
graphical images.
[0046] Further details of the controller 16 can be found in Nayak
et al, U.S. Pat. No. 6,261,065, which is incorporated herein by
reference. Further details of the interface can be found in Lyle et
al, U.S. Pat. No. 5,581,687, which is also incorporated herein by
reference.
[0047] As FIG. 26 shows, the lid 40 can be used to support other
input/outputs to couple other external devices to the controller 16
or other components of the device 14. For example, an ethernet port
50, or an input 52 for a bar code reader or the like (for scanning
information into the controller 16), or a diagnostic port 54, or a
port 56 to be coupled to a pressure cuff 58 (see FIG. 3), or a
system transducer calibration port 60, can all be conveniently
mounted for access on exterior of the lid 40, or elsewhere on the
case 36 of the device 14.
[0048] B. The Flow Set
[0049] The flow set 12 (see FIG. 3), is intended to be a sterile,
single use, disposable item. Before beginning a given blood
processing and collection procedure, the operator loads various
components of the flow set 12 in the case 36 in association with
the device 14 (as FIGS. 1 and 2 show). The controller 16 implements
the procedure based upon preset protocols, taking into account
other input from the operator. Upon completing the procedure, the
operator removes the flow set 12 from association with the device
14. The portion of the set 12 holding the collected blood component
or components are removed from the case 36 and retained for
storage, transfusion, or further processing. The remainder of the
set 12 is removed from the case 36 and discarded.
[0050] The flow set 12 can take various forms. In the illustrated
embodiment (see FIGS. 1 and 3), the flow set includes a blood
processing chamber 18 designed for use in association with a
centrifuge. Accordingly, the processing device 14 includes a
centrifuge station 20 (see FIG. 1), which receives the processing
chamber 18 for use (see FIG. 12).
[0051] As FIG. 1 shows, the centrifuge station 20 comprises a
compartment 21 formed in the base 38. The centrifuge station 20
includes a door 22, which opens and closes the compartment 21. The
door 22 opens (as FIG. 1 shows) to allow loading of the processing
chamber 18 into the compartment 21. The door 22 closes (as FIG. 2
shows) to enclose the processing chamber 18 within the compartment
21 during operation.
[0052] The centrifuge station 20 rotates the processing chamber 18.
When rotated, the processing chamber 18 centrifugally separates
whole blood received from a donor into component parts, e.g., red
blood cells, plasma, and platelets.
[0053] In the illustrated embodiment, the set 12 also includes a
fluid pressure actuated cassette 28 (see FIG. 29). The cassette 28
provides a centralized, programmable, integrated platform for all
the pumping and valving functions required for a given blood
processing procedure. In the illustrated embodiment, the fluid
pressure comprises positive and negative pneumatic pressure. Other
types of fluid pressure can be used.
[0054] The cassette 28 can take various forms. In a preferred
embodiment (see FIG. 29), the cassette 28 comprises an injection
molded body 200 made of a rigid medical grade plastic material.
Flexible diaphragms 202, preferably made of flexible sheets of
medical grade plastic, overlay the front side and back sides of the
cassette 28. The diaphragms are sealed about their peripheries to
the peripheral edges of the front and back sides of the cassette
28.
[0055] As FIG. 29 shows, the cassette 28 has an array of interior
cavities formed on both the front and back sides The interior
cavities define pneumatic pump stations (schematically designated
PS in FIG. 3), which are interconnected by a pattern of fluid flow
paths (schematically designated FP in FIG. 3) through an array of
in line, pneumatic valves (schematically designated V in FIG.
3).
[0056] As FIGS. 1 and 29 show, the cassette 28 interacts with a
pneumatic actuated pump and valve station 30, which is mounted in
the lid of the 40 of the case 36. The pump and valve station 30
includes a cassette holder 216. A door 32 is hinged to move with
respect to the cassette holder 216 between an opened position,
exposing the cassette holder 216 (shown in FIG. 1) for loading and
unloading the cassette 28, and a closed position, enclosing the
cassette 28 within the pump and valve station 30 for use (shown in
FIG. 2). The pump and valve station 30 includes pneumatic actuator
ports 204 (see FIG. 29) that apply positive and negative pneumatic
pressure upon the diaphragms of the cassette 28. The pneumatic
pressures displace the diaphragms 202 with respect to the pump
chambers and valves, to thereby direct liquid flow through the
cassette 28.
[0057] Further details of the cassette 28 and the operation of the
pump and valve station 30 can be found in Nayak et al, U.S. Pat.
No. 6,261,065, which is incorporated herein by reference.
[0058] Referred back to FIG. 3, the flow set 16 also includes an
array of tubes and containers in flow communication with the
cassette 28. The arrangement of tubes and containers can vary
according to the processing objectives. The system 10 can be
operated to collect red blood cells, plasma, red blood cells and
plasma, and platelets.
[0059] In the illustrated embodiment, the flow set 16 is arranged
to support the centrifugal collection of two units of red blood
cells (about 360 ml), and to filter the red blood cells to reduce
the number of leukocytes prior to storage. During this procedure,
whole blood from a donor is centrifugally processed in the chamber
18 into red blood cells (in which a majority of the leukocytes
resides) and a plasma constituent (in which a majority of the
platelets resides). The plasma constituent is returned to the
donor, while the targeted volume of red blood cells is collected,
filtered to reduce the population of leukocytes, and placed into
containers for storage mixed with a red blood cell storage
solution.
[0060] In this configuration (see FIG. 3), the flow set 16 includes
a donor tube 266 having an attached phlebotomy needle 268. The
donor tube 266 is coupled to a port of the cassette 28.
[0061] As FIG. 3 shows, a pressure cuff 58 is desirable used to
enhance venous blood flow through the phlebotomy needle 268 during
blood processing. The pressure cuff 58 is coupled to the pressure
cuff port 56 on the lid 40 (as previously described), and the
pressure supplied to the cuff 58 is desirably controlled by the
controller 16. The controller 16 can also operate a vein pressure
display 62 (see FIG. 26), which shows vein pressure at the pressure
cuff 56.
[0062] An anticoagulant tube 270 is coupled to the phlebotomy
needle 268. The anticoagulant tube 270 is coupled to another
cassette port. A container 276 holding anticoagulant is coupled via
a tube 274 to another cassette port.
[0063] A container 288 holding saline is coupled via a tube 284 to
another cassette port.
[0064] The set 16 further includes tubes 290, 292, 294, which
extend to an umbilicus 296. When installed in the processing
station, the umbilicus 296 links the rotating processing chamber 18
with the cassette 28 without need for rotating seals. In a
preferred embodiment, the umbilicus 296 is made from
rotational-stress-resistant Hytrel.RTM. copolyester elastomers
(DuPont). Further details of the construction of the umbilicus 296
will be provided later.
[0065] The tubes 290, 292, and 294 are coupled, respectively, to
other cassette ports. The tube 290 conveys whole blood into the
processing chamber 18. The tube 292 conveys plasma constituent from
the processing chamber 18. The tube 294 conveys red blood cells
from processing chamber 18.
[0066] A plasma collection reservoir 304 is coupled by a tube 302
to a cassette port. The collection reservoir 304 is intended, in
use, to serve as a reservoir for the plasma constituent during
processing prior to its return to the donor.
[0067] A red blood cell collection reservoir 308 is coupled by a
tube 306 to a cassette port. The collection reservoir 308 is
intended, in use, to receive red blood cells during processing. for
storage.
[0068] Two red blood cell storage containers 307 and 309 are
coupled by a tube 311 to another cassette port. A leukocyte
reduction filter 313 is carried in line by the tube 311. During
processing, red blood cells are transferred from the red blood cell
collection reservoir 308 through the filter 313 into the storage
containers 307 and 309.
[0069] A container 208 holding a red blood cell storage or additive
solution is coupled via a tube 278 to another cassette port. The
red blood cell storage solution is metered into the red blood cells
as they are conveyed from the container 308, through the filter
313, into the storage containers 307 and 309. Further details of
this aspect of the collection process will be described later.
[0070] A whole blood reservoir 312 is coupled by a tube 310 to a
cassette port. The collection container 312 is intended, in use, to
serve as a reservoir for whole blood during processing.
[0071] In the illustrated embodiment, the set 16 further includes a
fixture 338 (see FIG. 4) to hold the tubes 292 and 294 in viewing
alignment with an optical sensing station 332 in the base 36 (see
FIG. 12). The sensing station 332 optically monitors the presence
or absence of targeted blood components (e.g., platelets and red
blood cells) conveyed by the tubes 292 and 294. The sensing station
332 provides output reflecting the presence or absence of such
blood components. This output is conveyed to the controller 16. The
controller 16 processes the output and generates signals to control
processing events based, in part, upon the optically sensed events.
Further details of the operation of the controller to control
processing events based upon optical sensing can be found in Nayak
et al, U.S. Pat. No. 6,261,065, which is incorporated herein by
reference.
[0072] As FIG. 12 shows, the sensing station 332 is desirably
located within the confines of the centrifuge station 20. This
arrangement minimizes the fluid volume of components leaving the
chamber before monitoring by the sensing station 332.
[0073] The fixture 338 gathers the tubes 292 and 294 in a compact,
organized, side-by-side array, to be placed and removed as a group
in association with the sensing station 332. In the illustrated
embodiment, the fixture 338 also holds the tube 290, which conveys
whole blood into the processing chamber 18, even though no
associated sensor is provided. The fixture 338 serves to gather and
hold all tubes 290, 292, and 294 that are coupled to the umbilicus
296 in a compact and easily handled bundle.
[0074] The fixture 338 can be an integral part of the umbilicus
296, formed, e.g., by over molding. Alternatively, the fixture 338
can be a separately fabricated part, which snap fits about the
tubes 290, 292, and 294 for use.
[0075] As FIGS. 1 and 2 also show, the case 36 contains other
components compactly arranged to aid blood processing. In addition
to the centrifuge station 20 and pump and valve station 30, already
described, the case 36 includes a weigh station 238 and one or more
trays 212 or hangers 248 for containers. The arrangement of these
components in the case 36 can vary.
[0076] In the illustrated embodiment, the weigh station 238
comprises a series of container hangers/weigh sensors 246 arranged
along the top of the lid 40. In use, the containers 304, 308, 312
are suspended on the hangers/weigh sensors 246.
[0077] The holding trays 212 comprise molded recesses in the base
38. The trays 212 accommodate the containers 276 (containing
anticoagulant) and 208 (containing the red blood cell additive
solution). In the illustrated embodiment, an additional swing-out
side hanger 248 is also provided on the side of the lid 40. The
hanger 248 (see FIG. 2) supports the container 288 (containing
saline) during processing. Other swing out hangers 249 support the
red blood cells storage containers 307 and 309.
[0078] In the illustrated embodiment, the tray 212 holding the
container 276 and the hanger 248 also include weigh sensors
246.
[0079] As blood or liquids are received into and/or dispensed from
the containers during processing, the weigh sensors 246 provide
output reflecting weight changes over time. This output is conveyed
to the controller 16. The controller 16 processes the incremental
weight changes to derive fluid processing volumes. The controller
generates signals to control processing events based, in part, upon
the derived processing volumes. Further details of the operation of
the controller to control processing events can be found in Nayak
et al, U.S. Pat. No. 6,261,065, which is incorporated herein by
reference.
[0080] C. The Centrifugal Processing Chamber
[0081] FIGS. 5 to 7 show an embodiment of the centrifugal
processing chamber 18, which can be used in association with the
system 10 shown in FIG. 1 to perform the intended red blood cell
collection procedure. In the illustrated embodiment, the processing
chamber 18 is preformed in a desired shape and configuration, e.g.,
by injection molding, from a rigid, biocompatible plastic material,
such as a non-plasticized medical grade
acrilonitrile-butadiene-styrene (ABS).
[0082] In one arrangement, the chamber 18 can be fabricated in two
separately molded pieces; namely (as FIGS. 5 to 7 show), a base 388
and a lid 150. The base 388 includes a center hub 120. The hub 120
is surrounded radially by inside and outside annular walls 122 and
124. Between them, the inside and outside annular walls 122 and 124
define a circumferential blood separation channel 126. A molded
annular wall 148 closes the bottom of the channel 126.
[0083] The top of the channel 126 is closed by the separately
molded; flat lid 150 (which is shown separated in FIG. 5 for the
purpose of illustration). During assembly (see FIG. 7), the lid 150
is secured to the top of the chamber 18, e.g., by use of a
cylindrical sonic welding horn.
[0084] All contours, ports, channels, and walls that affect the
blood separation process may be preformed in the base 388 in a
single, injection molded operation, during which molding mandrels
are inserted and removed through the open end of the base 388
(shown in FIG. 5). The lid 150 comprises a simple flat part that
can be easily welded to the open end of the base 388 to close it
after molding. Because all features that affect the separation
process are incorporated into one injection molded component, any
tolerance differences between the base 388 and the lid 150 will not
affect the separation efficiencies of the chamber 18.
[0085] The contours, ports, channels, and walls that are preformed
in the base 388 may create surfaces within the base 388 that do not
readily permit the insertion and removal of molding mandrels
through a single end of the base 388. In this arrangement, the base
388 can be formed by separate molded parts, either by nesting cup
shaped subassemblies or two symmetric halves.
[0086] Alternatively, molding mandrels can be inserted and removed
from both ends of the base 388. In this arrangement (see FIG. 8),
the chamber 18 can be molded in three pieces; namely, the base 388,
the lid 150 (which closes one end of the base 388 through which top
molding mandrels are inserted and removed), and a separately molded
insert 151 (which closes the other end of the base 388 through
which bottom molding mandrels are inserted and removed.
[0087] The contours, ports, channels, and walls that are preformed
in the base 388 can vary.
[0088] As seen in FIG. 9, in one arrangement, the inside annular
wall 122 is open between one pair of stiffening walls. The opposing
stiffening walls form an open interior region 134 in the hub 120,
which communicates with the channel 126. Blood and fluids are
introduced from the umbilicus 296 into and out of the separation
channel 126 through this region 134.
[0089] In this embodiment (as FIG. 9 shows), a molded interior wall
136 formed inside the region 134 extends entirely across the
channel 126, joining the outside annular wall 124. The wall 136
forms a terminus in the separation channel 126, which interrupts
flow circumferentially along the channel 126 during separation.
[0090] Additional molded interior walls divide the region 134 into
three passages 142, 144, and 146. The passages 142, 144, and 146
extend from the hub 120 and communicate with the channel 126 on
opposite sides of the terminus wall 136. Blood and other fluids are
directed from the hub 120 into and out of the channel 126 through
these passages 142, 144, and 146.
[0091] The underside of the base 388 (see FIG. 7) includes a shaped
receptacle 179. The far end of the umbilicus 296 includes a shaped
mount 178 (see FIGS. 24 and 24A). The mount 178 is shaped to
correspond to the shape of the receptacle 179. The mount 178 can
thus be plugged into the receptacle 179 (as FIG. 7 shows), to
couple the umbilicus 296 in fluid communication with the channel
126.
[0092] The mount 178 is desirably made from a material that can
withstand considerable flexing and twisting, to which the mount 178
can be subjected during use, e.g., Hytrel.RTM. 3078 copolyester
elastomer (DuPont). The dimensions of the shaped receptacle 179 and
the shaped mount 178 are preferably selected to provide a tight,
dry press fit, to thereby avoid the need for solvent bonding or
ultrasonic welding techniques between the mount 178 and the base
388 (which can therefore be formed from an incompatible material,
such as ABS plastic).
[0093] D. The Centrifuge Assembly
[0094] The centrifuge station 20 (see FIG. 10) includes a
centrifuge assembly 48. The centrifuge assembly 48 is constructed
to receive and support the molded processing chamber 18 and
umbilicus 296 for use.
[0095] As illustrated (see FIGS. 10 and 11), the centrifuge
assembly 48 includes a yoke 154 having bottom, top, and side walls
156, 158, 160. The yoke 154 spins on a bearing element 162 (FIG.
11) attached to the bottom wall 156. An electric drive motor 164 is
coupled to the bottom wall 156 of the yoke 154, to rotate the yoke
154 about an axis 64. In the illustrated embodiment, the axis 64 is
essentially horizontal (see FIG. 1), although other angular
orientations can be used.
[0096] A rotor plate 166 (see FIG. 11) spins within the yoke 154
about its own bearing element 168, which is attached to the top
wall 158 of the yoke 154. The rotor plate 166 spins about an axis
that is generally aligned with the axis of rotation 64 of the yoke
154.
[0097] As FIG. 7 best shows, the top of the processing chamber 18
includes an annular lip 380, to which the lid 150 is secured. As
FIG. 12 shows, the rotor plate 166 includes a latching assembly 382
that removably grips the lip 380, to secure the processing chamber
18 on the rotor plate 166 for rotation.
[0098] The configuration of the latching assembly 382 can vary. In
the illustrated embodiment (see FIGS. 13 to 15), the latching
assembly 382 includes a latch arm 66 pivotally mounted on a pin in
a peripheral recess 68 in the rotor plate 166. The latch arm 66
pivots between a retaining position (shown in FIGS. 13 and 14) and
a releasing position (shown in FIG. 15).
[0099] In the retaining position (see FIG. 14), an annular groove
70 on the underside of the latch arm 66 engages the annular lip 380
of the processing chamber 18. The annular groove 70 on the latch
arm 66 coincides with an annular groove 71 that encircles the top
interior surface of the rotor plate 166. The engagement of the lip
380 within the groove 70/71 secures the processing chamber 18 to
the rotor plate 166.
[0100] In the releasing position (see FIG. 15), the annular groove
70 is swung free of engagement of the annular lip 380. This lack of
engagement allows release of the processing chamber 18 from the
remainder of the groove 71 in the rotor plate 166.
[0101] In the illustrated embodiment, the latching assembly 382
includes a sliding pawl 72 carried in a radial track 74 on the top
of the rotor plate. In the track 74, the pawl 72 slides radially
toward and away from the latch arm 66.
[0102] When the latch arm 66 is in its retaining position and the
pawl 72 is located in a radial position adjacent the latch arm 66
(see FIG. 14), a finger 76 on the pawl 72 slips into and engages a
cam recess 78 in the latch arm 66. The engagement between the pawl
finger 76 and latch arm cam recess 78 physically resists movement
of the latch arm 66 toward the releasing position, thereby locking
the latch arm 66 in the retaining position.
[0103] A spring 80 within the pawl 72 normally biases the pawl 72
toward this radial position adjacent the latch arm 66, where
engagement between the pawl finger 76 and latch arm cam recess 78
can occur. The latch arm 66 is thereby normally held by the pawl 72
in a locked, retaining position, to hold the processing chamber 18
during use.
[0104] The pawl 72 can be manually moved against the bias of the
spring 80 radially away from its position adjacent the latch arm 66
(see FIG. 15). During this movement, the finger 76 on the pawl 72
slips free of the cam recess 78 in the latch arm 66. Free of
engagement between the pawl finger 76 and latch arm cam recess 78,
the latch arm 66 is unlocked and can be pivoted toward its
releasing position. In the absence of manual force against the bias
of the spring 80, the pawl 72 returns by spring force toward its
position adjacent the latch arm 66, to lock the latch arm 66 in the
chamber retaining position.
[0105] In the illustrated embodiment (see FIG. 13), the top wall
158 of the yoke 154 carries a downward depending collar 82. The
collar 82 rotates in unison with the yoke 154, relative to the
rotor plate 166. The collar 82 includes a sidewall 84 that is
continuous, except for a cut away or open region 86.
[0106] As FIG. 17 best shows, the pawl 72 includes an upstanding
key element 88. The sidewall 84 of the collar 82 is located in the
radial path that the key element 88 travels when the pawl 72 is
manually moved against the bias of the spring 80 radially away from
its position adjacent the latch arm 66. The key element 88 abuts
against the collar sidewall 84, to inhibit movement of the pawl 72
in this direction, unless the open region 86 is aligned with the
key element 88, as shown in FIGS. 13 and 15. The open region 86
accommodates passage of the key element 88, permitting manual
movement of the pawl 72 against the bias of the spring 80 radially
away from its position adjacent the latch arm 66, thereby allowing
the latch arm 66 to pivot into its releasing position.
[0107] The interference between the collar sidewall 84 and the key
element 88 of the pawl 72 prevents manual movement of the pawl 72
away from the latch arm 66, to unlock the latch arm 66 for movement
into its releasing position, unless the open region 86 and the key
element 88 register. The open region 86 is aligned on the yoke 154
so that this registration between the open region 86 and the key
element 88 occurs only when the rotor plate 166 is in a prescribed
rotational position relative to the yoke 154. In this position (see
FIG. 12), the sidewalls 160 of the yoke 154 are located generally
parallel to the plane of the opening to the compartment, providing
open access to the interior of the yoke 154. In this position (see
FIG. 16), the processing chamber 18 can be freely placed without
interference into the interior of the yoke 154, and loaded onto the
rotor plate 166. In this position, uninhibited manual movement of
the pawl 72 allows the operator to pivot the latch arm 66 into its
releasing position, to bring the lid 150 of the chamber 18 into
contact against the rotor plate 166. Subsequent release of the pawl
72 returns the pawl 72 toward the latch arm 66 and allows the
operator to lock the latch arm 66 in its retaining position about
the lip 380 of the chamber 18. The reverse sequence is accommodated
when it is time to remove the processing chamber 18 from the rotor
plate 166.
[0108] This arrangement makes possible a straightforward sequence
of acts to load the processing chamber 18 for use and to unload the
processing chamber 18 after use (see FIG. 16). As FIGS. 17 and 18
further show, easy loading of the umbilicus 296 is also made
possible in tandem with fitting the processing chamber 18 to the
rotor plate 166.
[0109] A sheath 182 on the near end of the umbilicus 296 fits into
a preformed, recessed pocket 184 in the centrifuge station 20. The
pocket 184 holds the near end of the umbilicus 296 in a
non.quadrature.rotating stationary position aligned with the
mutually aligned rotational axes 64 of the yoke 154 and rotor plate
166.
[0110] The preformed pocket 184 is also shaped to accommodate
loading of the fixture 338 at the same time the sheath 182 is
inserted. The tubes 290, 292, and 294 are thereby placed and
removed as a group in association with the sensing station 332,
which is located within the pocket 184.
[0111] Umbilicus support members 186 and 187 (see FIG. 12) are
carried by a side wall 160 of the yoke 154. When the rotor plate
166 is located in its prescribed rotational position to enable easy
loading of the chamber 18 (see FIGS. 17 and 18), the support
members 186 and 187 are presented on the left side of the
processing chamber 18 to receive the umbilicus 296 at the same time
that the sheath 182 and fixture 338 are manipulated for fitting
into the pocket 184.
[0112] As FIG. 19 shows, one member 186 receives the mid portion of
the umbilicus 296. The member 186 includes a surface 188 against
which the mid portion of the umbilicus 296 rests. The surface 188
forms a channel that extends generally parallel to the rotational
axis 64 and that accommodates passage of the mid portion of the
umbilicus 296. The surface 188 inhibits travel of the mid portion
of the umbilicus 296 in radial directions toward and away from the
rotational axis 64. However, the surface 188 permits rotation or
twisting of the umbilicus 296 about its own axis.
[0113] The other member 187 receives the upper portion of the
umbilicus 296. The member 187 includes a surface 190 against which
the upper portion of the umbilicus 296 rests. The surface 190 forms
a channel inclined toward the top wall 158 of the yoke 154. The
surface 190 guides the upper portion of the umbilicus 296 toward
the recessed pocket 184, which is located axially above the top
wall 158 of the yoke 154, where the umbilicus sheath 182 and
fixture 338 are fitted. Like the surface 188, the surface 190
inhibits travel of the upper portion of the umbilicus 296 in radial
directions toward and away from the rotational axis 64. However,
like the surface 188, the surface 190 permits rotation or twisting
of the umbilicus 296 about its own axis.
[0114] Closing the centrifuge station door 20 positions a holding
bracket 90 on the underside of the door 20 in registry with the
sheath 182 (see FIGS. 17 and 18). Another holding bracket 92 on the
underside of the door 20 is positioned in registry with the fixture
338 when the door 20 is closed. A releasable latch 94 preferably
holds the door shut during operation of the centrifuge assembly
48.
[0115] During operation of the centrifuge assembly 48 (see FIGS. 19
to 22), the support members 186 and 187 carry the umbilicus 296 so
that rotation of the yoke 154 also rotates the umbilicus 296 in
tandem about the yoke axis. Constrained within the pocket 184 at
its near end (i.e., at the sheath 182) and coupled to the chamber
16 at its far end (i.e., by the mount 178), the umbilicus 296
twists upon the surfaces 188 and 190 about its own axis as it
rotates about the yoke axis 64, even as the surfaces 188 and 190
inhibit radial travel of the umbilicus relative to the rotation
axis 64. The twirling of the umbilicus 296 about its axis as it
rotates upon the surfaces 188 and 190 at one omega with the yoke
154 (typically at a speed of about 2250 RPM) imparts a two omega
rotation to the processing chamber 18 secured for rotation on the
rotor plate 166.
[0116] The relative rotation of the yoke 154 at a one omega
rotational speed and the rotor plate 166 at a two omega rotational
speed, keeps the umbilicus 296 untwisted, avoiding the need for
rotating seals. The illustrated arrangement also allows a single
drive motor 164 to impart rotation, through the umbilicus 296, to
the mutually rotating yoke 154 and processing chamber 18 carried on
the rotor plate 166. Further details of this arrangement are
disclosed in Brown et al U.S. Pat. No. 4,120,449, which is
incorporated herein by reference.
[0117] The umbilicus 296 can stretch in response to the rotational
forces it encounters. The dimensions of a given umbilicus 296 are
also subject to normal manufacturing tolerances. These factors
affect the flight radius of the umbilicus 296 during use; as well
as the stress encountered by the mount 178 at the far end of the
umbilicus 296, which serves as the two omega torque transmitter to
drive the processing chamber 18; as well as the lateral loads
acting on the centrifuge and motor bearings.
[0118] As FIGS. 19 to 22 show, the support members 186 and 187 on
the yoke serve to physically confine the flight of the umbilicus
296 between the one omega region (mid portion) and two omega region
(far end portion), as well as between the one omega region (mid
portion) and zero omega region (near end portion) of the umbilicus
296. By confining the umbilicus 296 to a predefined radial distance
from and radial orientation with respect to the rotational axis of
the centrifuge assembly 48, the support members 186 and 187 serve
to attenuate the factors that can affect umbilicus performance and
endurance.
[0119] The support members 186 and 187 make possible a bearing-less
umbilicus assembly with no moving parts, while leading to reduced
stress at the two omega torque region, where stresses tend to be
greatest. The surfaces 188 and 190 of the support members 186 and
187 can be formed and oriented to accommodate rotation of the
umbilicus 296 and the driving of the processing chamber 18 in
either clockwise or counterclockwise directions.
[0120] In the illustrated embodiment, the surfaces 188 and 190 of
the support members 186 and 187 are preferably fabricated from a
low friction material, to thereby eliminate the need for external
lubrication or rotating bearings on the umbilicus 296 itself. The
material used can, e.g., comprise Teflon.RTM.
polytetrafluoroethylene material (DuPont) or an ultra high
molecular weight polyethylene. Made from such materials, the
surfaces 188 and 190 minimize umbilicus drive friction and the
presence of particulate matter due to umbilicus wear.
[0121] In a representative embodiment (see FIG. 4), the umbilicus
296 desirably comprises a two layer co-extruded assembly. The
interior or core layer 96 desirably comprises Hytrel.RTM. 4056
copolyester elastomer (DuPont). The outside layer 98 desirably
comprises Hytrel.RTM. 3078 copolyester elastomer (DuPont). The
outside layer 98 may comprise a relatively thin extrusion, compared
to the core layer 96.
[0122] In this arrangement, the outside layer 98 of Hytrel.RTM.
3078 copolyester elastomer serves as a compatible interface to
accommodate over-molding of the zero omega sheath 182 and the two
omega mount 178, which may comprise the same Hytrel.RTM. 3078
material or an otherwise compatible material. Absent material
compatibility, solvents (e.g., methylene chloride) or other forms
of surface treatment may be required to facilitate a robust bond
between these elements and the umbilicus. Hytrel.RTM. 3078 material
is desired for the sheath 182, and the mount 178 because it can
withstand considerable flexing and twisting forces, to which these
regions of the umbilicus are subjected during use.
[0123] The core layer 96 of Hytrel.RTM. 4056 copolyester elastomer
can be readily solvent bonded to conventional flexible medical
grade polyvinyl tubing, from which the tubes 290, 292, and 294 are
desirably made.
II. Double Red Blood Cell Collection Procedure
[0124] Use of the set 12 in association with the device 14 and
controller 16 to conduct a typical double unit red blood cell
collection procedure will now be described for illustrative
purposes.
[0125] A. The Cassette
[0126] The cassette 28 used for a procedure of this type desirably
includes dual pneumatic pump chambers PP3 and PP4 (see FIG. 23)
which are operated by the controller 16 in tandem to serve as a
general purpose, donor interface pump. The dual donor interface
pump chambers PP3 and PP4 work in parallel. One pump chamber draws
fluid, while the other pump chamber expels fluid. The dual pump
chambers PP3 and PP4 thereby alternate draw and expel functions to
provide a uniform outlet flow.
[0127] The cassette 28 also desirably includes a pneumatic pump
chamber PP5, which serves as a dedicated anticoagulant pump, to
draw anticoagulant from the container 276 and meter the
anticoagulant into the blood drawn from the donor.
[0128] The cassette 28 also desirably includes a pneumatic pump
chamber PP1 that serves as a dedicated in-process whole blood pump,
to convey whole blood from the reservoir 312 into the processing
chamber 18. The dedicated function of the pump chamber PP1 frees
the donor interface pump chambers PP3 and PP4 from the added
function of supplying whole blood to the processing chamber 18.
Thus, the in-process whole blood pump chamber PP1 can maintain a
continuous supply of blood to the processing chamber 18, while the
donor interface pump chambers PP3 and PP4 operate in tandem to
simultaneously draw and return blood to the donor through the
single phlebotomy needle. Processing time is thereby minimized.
[0129] The cassette 28 also desirably includes a pneumatic pump
chamber PP2 that serves as a plasma pump, to convey plasma from the
processing chamber 18. The ability to dedicate separate pumping
functions provides a continuous flow of blood into and out of the
processing chamber 18, as well as to and from the donor.
[0130] B. Capacitive Flow Sensing
[0131] The controller 16 desirably includes means for monitoring
fluid flow through the pump chambers PP1 to PP5. In the illustrated
embodiment, the pump and valve station 30 carries electrode
circuits 206 associated with each pump chamber PP1 to PP5. The
electrode circuits 206 can be located, e.g., within the pneumatic
actuator ports 204 in the pump and valve station 30 (see FIG. 29)
that apply negative and positive pressure to the diaphragms to
thereby draw fluid into the chambers PP1 to PP5 and expel fluid
from the chambers PP1 to PP5. The electrode circuits 206 are
coupled to an electrical source and are in electrical conductive
contact with fluids within their respective pump chambers PP1 and
PP5.
[0132] The passage of electrical energy through each electrode
circuit 206 creates an electrical field within the respective pump
chamber PP1 to PP5. Cyclic deflection of the diaphragm associated
with a given pump chamber to draw fluid into and expel fluid from
the pump chamber PP1 to PP5 changes the electrical field, resulting
in a change in total capacitance of the circuit through the
electrode. Capacitance increases as fluid is draw into the pump
chamber PP1 to PP5, and capacitance decreases as fluid is expelled
from pump chamber PP1 to PP5.
[0133] In the arrangement, the electrode circuits 206 each includes
a capacitive sensor (e.g., a Qprox E2S). The capacitive sensor
registers changes in capacitance for the electrode circuit 206 for
each pump chamber PP1 to PP5. The capacitance signal for a given
electrode circuit 206 has a high signal magnitude when the pump
chamber is filled with liquid, has a low signal magnitude signal
when the pump chamber is empty of fluid, and has a range of
intermediate signal magnitudes when the diaphragm occupies
intermediate positions.
[0134] At the outset of a blood processing procedure, the
controller 16 can calibrate the difference between the high and low
signal magnitudes for each sensor to the maximum stroke volume of
the respective pump chamber. The controller 16 can then relate the
difference between sensed maximum and minimum signal values during
subsequent draw and expel cycles to fluid volume drawn and expelled
through the pump chamber. The controller 16 can sum the fluid
volumes pumped over a sample time period to yield an actual flow
rate.
[0135] The controller 16 can compare the actual flow rate to a
desired flow rate. If a deviance exists, the controller 16 can vary
pneumatic pressure pulses delivered to the actuators for the pump
chambers PP1 to PP5 to minimize the deviance.
[0136] The controller 16 can also operate to detect abnormal
operating conditions based upon the variations in the electric
field and to generate corresponding alarm outputs. The controller
16 can, e.g., monitor for an increase in the magnitude of the low
signal magnitude over time. The increase in magnitude reflects the
presence of air inside a pump chamber.
[0137] For example, the controller 16 can generate a derivative of
the signal output of the sensor 426. Changes in the derivative, or
the absence of a derivative, reflects a partial or complete
occlusion of flow through the pump chamber PP1 to PP5. The
derivative itself also varies in a distinct fashion depending upon
whether the occlusion occurs at the inlet or outlet of the pump
chamber PP1 to PP5.
[0138] 1. Monitoring Vein Flow Conditions
[0139] By using capacitive sensing and by also counting pump
strokes (i.e., the application of negative pressure upon the
diaphragm of a given pump chamber to draw fluid into the chamber),
the controller 16 can also monitor vein flow conditions, and, in
particular, assess and respond to real or potential vein occlusion
conditions.
[0140] When blood is pumped from the donor, the donor's vein may
show difficulties in keeping up with the commanded draw rate that
operation of the donor pump chambers PP3/PP4 imposes. In the case
of restricted blood flow from the donor, the donor pumps PP3 and
PP4 do not fill properly in response to the commanded sequence of
pump strokes. The controller 16 attempts to assess and mediate
blood supply interruptions due to vein problems before generating a
vein occlusion alarm, which suspends processing.
[0141] For example, the controller 16 can count the number of
consecutive attempted pump strokes for which no blood flow into the
pump chambers PP3 and PP4 occurs (which blood flow or absence of
blood flow can be detected by capacitive sensing, as above
described). A potential donor draw occlusion condition can be
deemed to occur when a prescribed number (e.g., 3) of consecutive
incomplete fill donor pump strokes takes place.
[0142] When a potential donor draw occlusion condition is detected,
the controller 16 attempts to rectify the condition by increasing
pressure of the pressure cuff 58 and/or decreasing the commanded
draw rate, before generating a processing-halting vein occlusion
alarm.
[0143] More particularly, in a representative implementation, when
a donor draw occlusion condition is detected, the controller 16
executes a potential draw occlusion condition function (in
shorthand, the "Potential Occlusion Function"). The Potential
Occlusion Function first suspends the draw for a period of time
(e.g. upwards to 20 seconds, and desirably about 10 seconds) to
rest the vein. While the vein rests, the controller 16 also
increases the pressure cuff pressure by a preset increment (e.g.,
upwards to 25 mmHg, and desirably about 10 mmHg), unless cuff
pressure, when adjusted, exceeds a prescribed maximum (e.g.,
upwards to 100 mmHg, desirably about 70 mmHg). If the prescribed
maximum cuff pressure condition exists, no incremental changes to
the cuff pressure are made during the prescribed vein rest
interval.
[0144] After the prescribed vein rest interval, the Potential
Occlusion Function resets the attempted pump stroke counter to zero
and resumes the draw cycle. The controller 16 monitors the initial
series of consecutive pump strokes during the resumed draw cycle,
up to a first threshold number of pump strokes (e.g., 5). The
magnitude of the first threshold number is larger that the number
of consecutive incomplete fill donor pump strokes (i.e., 3) that
indicate a potential donor draw occlusion condition. The magnitude
of the first threshold number is selected to accurate assess, after
a potential donor draw occlusion condition arises, whether a true
donor draw occlusion exists. In the illustrated embodiment, if
within the first five pump strokes (or whatever the first threshold
number is), three consecutive incomplete fill donor pump strokes
take place, the controller 16 assumes that a true donor draw
occlusion exists, and thus generates an occlusion alarm. With the
generation of an occlusion alarm, the controller 16 suspends
processing, until the operator can establish that it is safe to
resume.
[0145] If within the first threshold number of pump strokes, three
consecutive incomplete fill donor pump strokes do not take place,
the controller 16 assumes that a true vein occlusion may not exists
and that the potential occluded flow condition was either
transient, or at least capable of correction short of suspending
the procedure. In this event, the Potential Occlusion Function
allows the resumed draw cycle to continue beyond the first
threshold number of pump strokes up to a second threshold number of
pump strokes (e.g., 20 to 100, and desirable about 50).
[0146] If at any time between the first threshold number of pump
strokes and the second threshold number of pump strokes, three
consecutive incomplete fill donor pump strokes take place, the
Potential Occlusion Function institutes another vein rest interval
(e.g. upwards to 20 seconds, and desirably about 10 seconds). While
the vein rests, the Potential Occlusion Function also again
increases the pressure cuff pressure by a preset increment (e.g.,
upwards to 25 mmHg, and desirably about 10 mmHg). While the vein
rests, the Potential Occlusion Function also lowers the draw rate
by a preset decrement (e.g., upwards to 20 ml/min, and desirably
about 10 ml/min). If the draw rate, when lowered, is less than a
prescribed minimum draw rate (e.g., 70 to 90 ml/min), the
controller 16 generates an occlusion alarm. Otherwise, the
Potential Occlusion Function resets the attempted pump stroke
counter to zero, and resumes the draw cycle at the increased cuff
pressure and decreased draw rate.
[0147] The controller 16 again monitors the initial series of
consecutive pump strokes during the resumed draw cycle, up to the
first threshold number of pump strokes (e.g., 5). If within the
first threshold number of pump strokes, three consecutive
incomplete fill donor pump strokes take place, the controller 16
assumes that a true donor draw occlusion exists, and thus generates
an occlusion alarm and also suspends processing.
[0148] However, if within the first threshold number of pump
strokes, three consecutive incomplete fill donor pump strokes do
not take place, the controller 16 allows the resumed draw cycle to
continue beyond the first threshold number of pump strokes up to
the second threshold number of pump strokes (e.g., 20 to 100, and
desirable about 50). If at any time between the first threshold
number of pump strokes and the second threshold number of pump
strokes, three consecutive incomplete fill donor pump strokes take
place, the Potential Occlusion Function again institutes another
vein rest interval (e.g. upwards to 20 seconds, and desirably about
10 seconds). While the vein rests, the Potential Occlusion Function
also again increases the pressure cuff pressure by a preset
increment (e.g., upwards to 25 mmHg, and desirably about 10 mmHg).
While the vein rests, the Potential Occlusion Function also again
lowers the draw rate by a preset decrement (e.g., upwards to 20
ml/min, and desirably about 10 ml/min), unless the draw rate, when
lowered, is less than a prescribed minimum draw rate (e.g., 70 to
90 ml/min), in which case the controller 16 generates an occlusion
alarm. Otherwise, the Potential Occlusion Function resets the
attempted pump stroke counter to zero, and resumes the draw cycle
at the increased cuff pressure and decreased draw rate.
[0149] The controller 16 continues to repeat the steps of the
Potential Occlusion Function, using the first and second pump
stroke number thresholds to gage whether a true vein occlusion
exists, and either generating an occlusion alarm if it does, or
continuing to attempt remedial action (by increasing cuff pressure
and/or decreasing draw rate), or cancelling the potential donor
draw occlusion condition when three consecutive incomplete fill
donor pump strokes are not observed during either the first or
second threshold periods following a potential donor occlusion
condition.
[0150] If no three consecutive incomplete fill donor pump strokes
take place within the second threshold number of strokes following
a potential donor draw occlusion condition, the controller 16
assumes that a true vein occlusion does not exist. The draw cycle
continues, and the controller 16 continues to count pump strokes.
If the prescribed number (e.g., 3) of consecutive incomplete fill
donor pump strokes subsequently takes place, the controller 16
assumes that this event is unrelated to any previous occlusion
event condition, and generates a new potential donor draw occlusion
condition, executing the Potential Occlusion Function from the
start.
[0151] It should be appreciated that the Potential Occlusion
Function, as just described, can be used with any blood processing
device that has means for detecting when a draw blood pumping
command does not result in blood flow through the pump.
[0152] C. Blood Processing Cycles
[0153] Prior to undertaking the double unit red blood cell
collection procedure, as well as any blood collection procedure,
the controller 16 conducts an appropriate integrity check of the
cassette 28, to determine whether there are any leaks in the
cassette 28. Once the cassette integrity check is complete and no
leaks are found, the controller 16 begins the desired blood
collection procedure.
[0154] In general, using the processing chamber shown in FIG. 9),
whole blood is introduced into and separated within the processing
chamber 18 as it rotates. As the processing chamber 18 rotates
(arrow R in FIG. 9), the umbilicus 296 conveys whole blood into the
channel 126 through the passage 146. The whole blood flows in the
channel 126 in the same direction as rotation (which is
counterclockwise in FIG. 9). Alternatively, the chamber 18 can be
rotated in a direction opposite to the circumferential flow of
whole blood, i.e., clockwise, but rotation in the same direction as
circumferential blood flow is preferred.
[0155] The whole blood separates as a result of centrifugal forces.
Red blood cells are driven toward the high.quadrature.G wall 124,
while lighter plasma constituent is displaced toward the
low.quadrature.G wall 122. In this flow pattern, a dam 384 projects
into the channel 126 toward the high-G wall 124. The dam 384
prevents passage of plasma, while allowing passage of red blood
cells into a channel 386 recessed in the high-G wall 124. The
channel 386 directs the red blood cells into the umbilicus 296
through the radial passage 144. The plasma constituent is conveyed
from the channel 126 through the radial passage 142 into umbilicus
296.
[0156] 1. Collection Cycle
[0157] During a typical collection cycle of the double unit red
blood cell collection procedure, whole blood drawn from the donor
is processed to collect two units of red blood cells, while
returning plasma to the donor. The donor interface pumps PP3/PP4 in
the cassette, the anticoagulant pump PS in the cassette, the
in-process pump PP1 in the cassette, and the plasma pump PP2 in the
cassette are pneumatically driven by the controller 16, in
conjunction with associated pneumatic valves, to draw
anticoagulated blood into the in-process container 312, while
conveying the blood from the in-process container 312 into the
processing chamber 18 for separation. This arrangement also removes
plasma from the processing chamber into the plasma container 304,
while removing red blood cells from the processing chamber into the
red blood cell container 308. This phase continues until an
incremental volume of plasma is collected in the plasma collection
container 304 (as monitored by a weigh sensor) or until a targeted
volume of red blood cells is collected in the red blood cell
collection container (as monitored by a weigh sensor).
[0158] If the volume of whole blood in the in-process container 312
reaches a predetermined maximum threshold before the targeted
volume of either plasma or red blood cells is collected, the
controller 16 terminates operation of the donor interface pumps
PP3/PP4 to terminate collection of whole blood in the in-process
container 312, while still continuing blood separation. If the
volume of whole blood reaches a predetermined minimum threshold in
the in-process container 312 during blood separation, but before
the targeted volume of either plasma or red blood cells is
collected, the controller 16 returns to drawing whole blood to
thereby allow whole blood to enter the in-process container 312.
The controller toggles between these two conditions according to
the high and low volume thresholds for the in-process container
312, until the requisite volume of plasma has been collected, or
until the target volume of red blood cells has been collected,
whichever occurs first.
[0159] 2. Return Cycle
[0160] During a typical return cycle (when the targeted volume of
red blood cells has not been collected), the controller 16 operates
the donor interface pumps PP3/PP4 within the cassette 28, the
in-process pump PP1 within the cassette, and the plasma pump PP2
within the cassette, in conjunction with associated pneumatic
valves, to convey anticoagulated whole blood from the in-process
container 312 into the processing chamber 18 for separation, while
removing plasma into the plasma container 304 and red blood cells
into the red blood cell container 308. This arrangement also
conveys plasma from the plasma container 304 to the donor, while
also mixing saline from the container 288 in line with the returned
plasma. The in line mixing of saline with plasma raises the saline
temperature and improves donor comfort. This phase continues until
the plasma container 304 is empty, as monitored by the weigh
sensor.
[0161] If the volume of whole blood in the in-process container 312
reaches a specified low threshold before the plasma container 304
empties, the controller 16 terminates operation of the in-process
pump PP1 to terminate blood separation. The phase continues until
the plasma container 304 empties.
[0162] Upon emptying the plasma container 304, the controller 16
conducts another collection cycle. The controller 16 operates in
successive collection and return cycles until the weigh sensor
indicates that a desired volume of red blood cells have been
collected in the red blood cell collection container 308. The
controller 16 terminates the supply and removal of blood to and
from the processing chamber, while operating the donor interface
pumps PP3/PP4 in the cassette 28 to convey plasma remaining in the
plasma container 304 to the donor. The controller 16 next operates
the donor interface pumps PP3/PP4 in the cassette to convey the
blood contents remaining in the in-process container 312 to the
donor as well as convey saline to the donor, until a prescribed
replacement volume amount is infused, as monitored by a weigh
sensor.
[0163] 3. In-Line Leukofiltration Cycle
[0164] When the collection of red blood cells and the return of
plasma and residual blood components has been completed, the
controller 16 switches, either automatically or after prompting the
operator, to an in-line leukofiltration cycle. During this cycle,
red blood cells are removed from the red blood cell collection
reservoir 308 and conveyed into the red blood cell storage
containers 307 and 308 through the leukocyte removal filter 313. At
the same time, a desired volume of red blood cell storage solution
from the container 208 is mixed with the red blood cells.
[0165] In the first stage of this cycle, the controller 16 operates
donor interface pumps PP3/PP4 in the cassette to draw air from the
red blood cell storage containers 307 and 309, the filter 313, and
the line 311, and to transfer this air into the red blood cell
collection reservoir 308. This stage minimizes the volume of air
residing in the red blood cell storage containers 307 and 309
before the leukocyte removal process begins. The stage also
provides a volume of air in the red blood cell collection container
308 that can be used purge red blood cells from the filter 313 into
the red blood cell collection containers 307 and 309 once the
leukocyte removal process is completed.
[0166] In the next stage, the controller 16 operates the donor
interface pumps PP3/PP4 in the cassette 28 to draw a priming volume
of storage solution from the solution container 208 into the red
blood cell collection reservoir 308. This stage primes the tubing
278 between the container 208 and the cassette 28, to minimize the
volume of air pumped into the final red blood cell storage
containers 307 and 309.
[0167] In the next stage, the controller 16 operates the donor
interface pumps PP3/PP4 in the cassette 28 to alternate pumping red
blood cells from the red blood cell collection reservoir 308 into
the red blood cell collection containers 307 and 309 (through the
filter 313), with pumping of red blood cell storage solution from
the container 208 into the red blood cell collection containers 307
and 309 (also through the filter 313). This alternating process
mixes the storage solution with the red blood cells. The controller
16 counts the pneumatic pump strokes for red blood cells and the
storage solution to obtain a desired ratio of red cell volume to
storage solution volume (e.g., five pump strokes for red blood
cells, followed by two pump strokes for storage solution, and
repeating the alternating sequence). This alternating supply of red
blood cells and storage solution continues until the weigh scale
for the red blood cell collection reservoir 308 indicates that the
reservoir 308 is empty.
[0168] When the red blood cell collection reservoir 308 is empty,
the controller 16 operates the donor interface pumps PP3/PP4 to
pump additional storage solution through the filter 313 and into
the red blood storage containers 307 and 309, to ensure that a
desired ratio between storage solution volume and red blood cell
volume exists.
[0169] This also rinses residual red blood cells from the filter
313 into the red blood cell storage containers 307 and 309 to
maximize post-filtration percent red blood cell recovery.
[0170] The controlled ratio of pump strokes for red blood cells and
for storage solution that the controller 16 achieves ensures that
the storage solution is always metered in at a constant ratio.
Therefore, regardless of the volume of red blood cells collected,
the final red blood cell/storage solution hematocrit can be
constant.
[0171] The alternating supply of red blood cells and storage
solution through the filter 313 eliminates the need to first drain
the storage solution into the red blood cell collection reservoir
308, which lessens the overall procedure time.
[0172] The alternating supply of red blood cells and storage
solution through the filter 313 also eliminates the need to
manually agitate a red blood cell/storage solution mixture prior to
leukofiltration. Due to density differences, when concentrated red
blood cells are added to a preservation solution, or vice versa,
the preservation solution floats to the top. Poorly mixed, high
hematocrit, high viscosity red blood cells lead to reduced flow
rates during leukofiltration. Poorly mixed, high hematocrit, high
viscosity red blood cell conditions can also lead to hemolysis. By
alternating passage of red blood cells and storage solution through
the filter 313, mixing occurs automatically without operator
involvement.
[0173] The alternating supply of red blood cells and storage
solution through the filter 313 also eliminates the need to gravity
drain the red blood cell product through the leukofilter 313. As a
result, filtration can occur in about half the time required for a
gravity-drain procedure.
[0174] If desired, the controller 16 can monitor weight changes
relating to the red blood cell collection reservoir 308 and the red
blood cell storage containers 307 and 309, to derive a value
reflecting the percent of red blood cells that are recovered after
passage through the leukofilter 313. This value can be communicated
to the operator, e.g., on the display screen of user the user
interface.
[0175] The following expression can be used to derive the percent
recovery value:
% Recovery=[(Bag A Vol+Bag B Vol)/RBC Vol+Adsol)]*100
[0176] where:
[0177] Bag A Vol represents the volume of red blood cells collected
the container 307, calculated as follows:
(Wt of Container 307 containing red blood cells(in g)-Container 307
Tare)/1.062 g/ml
[0178] Bag B Vol represents the volume of red blood cells collected
the container 309, calculated as follows:
(Wt of Container 309 containing red blood cells(in g)-Container 309
Tare)/1.062 g/ml
[0179] RBC Vol represents the volume of red blood cells collected
in the red blood cell collection reservoir 308, which the
controller 16 determines by weight sensing at the end of the
procedure.
[0180] Adsol represents the volume of red blood cell storage
solution added to the during leukofiltration, which is determined
by the controller 16 by capacitive sensing during processing.
[0181] a. The Leukofilter
[0182] The leukofilter 313 can be variously constructed. In the
embodiment illustrated in FIGS. 24A and 24B, the filter comprises a
housing 100 inclosing a filtration medium 102 that can comprise a
membrane or be made from a fibrous material. The filtration medium
102 can be arranged in a single layer or in a multiple layer stack.
If fibrous, the medium 102 can include melt blown or spun bonded
synthetic fibers (e.g., nylon or polyester or polypropylene),
semi-synthetic fibers, regenerated fibers, or inorganic fibers. If
fibrous, the medium 102 removes leukocytes by depth filtration. If
a membrane, the medium 102 removes leukocytes by exclusion.
[0183] The housing 100 can comprise rigid plastic plates sealed
about their peripheries. In the illustrated embodiment, the housing
100 comprises first and second flexible sheets 104 of medical grade
plastic material, such as polyvinyl chloride plasticized with
di-2-ethylhexyl-phthalate (PVC-DEHP). Other medical grade plastic
materials can be used that are not PVC and/or are DEHP-free.
[0184] In the illustrated embodiment, a unitary, continuous
peripheral seal 106 (see FIG. 24B) is formed by the application of
pressure and radio frequency heating in a single process to the two
sheets 104 and filtration medium 102. The seal 106 joins the two
sheets 104 to each other, as well as joins the filtration medium
102 to the two sheets 104. The seal 106 integrates the material of
the filtration medium 102 and the material of the plastic sheets
104, for a reliable, robust, leak-proof boundary. Since the seal
106 is unitary and continuous, the possibility of blood shunting
around the periphery of the filtration medium 102 is
eliminated.
[0185] The filter 313 also includes inlet and outlet ports 108. The
ports 108 can comprise tubes made of medical grade plastic
material, like PVC-DEHP. In the embodiment shown in FIG. 24, the
ports 108 comprise separately molded parts that are heat sealed by
radio frequency energy over a hole 109 formed in the sheets 104
(see FIG. 24B).
[0186] In the illustrated embodiment (as FIGS. 25A and 25B show),
the filter 313 is desirably placed within a restraining fixture 110
during use. The fixture 110 restrains expansion of the flexible
sheets 104 of the filter housing 100 as a result of pressure
applied by pumping red blood cells through the filter 313. The
fixture 110 keeps the total blood volume in the filter 313 at a
minimum through the filtration process, thereby decreasing
filtration time, as well as increasing the red blood cell recovery
percentage following leukofiltration.
[0187] The fixture 110 can take various forms. In the illustrated
embodiment, the fixture 110 comprises two plates 112 coupled by a
hinge 114. The fixture 110 can be placed in an open condition (as
FIG. 25A shows) to receive the filter 313 prior to leukofiltration,
or to remove the filter 313 following leukofiltration. The fixture
110 can also be placed in a closed condition (as FIG. 25B shows) to
sandwich the filter 313 between the two plates 112. A releasably
latch 116 holds the plates 112 in the closed condition for use.
[0188] The plates 112 maintain a desired gap clearance, thereby
restraining expansion of the filter 313 during use. The gap
clearance is selected to maintain a desired blood flow rate at a
desired minimum blood volume.
[0189] The plates 112 desirably include indentations 118 in which
the ports 108 of the filter 313 rest in a non-occluded condition
when the fixture 110 is closed. The interior surfaces of the plates
112 may be roughed or scored with a finish to aid blood flow
through the filter 313 when the fixture 110 is closed.
[0190] The fixture 110 can be made as a stand-alone item that can
be separately stored prior to use. It can be stored in association
with the device 14 during transport and prior to use, e.g., in a
receptacle 128 formed on the exterior of the lid 40 of the device
14 (see FIG. 26). The fixture 110 can include a mounting bracket
130 (see FIG. 28) that, e.g., slidably engages a mating mounting
track 132, to hold the fixture 110 in the receptacle 128 prior to
use (shown in phantom lines in FIG. 26) or to secure the fixture
110 on the base 38 as leukofiltration is carried out (see FIG.
27).
[0191] It should be appreciated that pump-assisted leukofiltration
of red blood cells, whole blood, or other blood cell products,
wherein blood flow through a leukofilter is not driven strictly by
gravity flow, can be carried out using manual or automated systems
having configurations different than those shown in this
Specification. For example, external peristaltic or fluid actuated
pumping devices can be used to transfer whole blood or manually
processed blood products from separation bags into processing or
storage containers through intermediate leukofiltration devices. It
should also be appreciated that a filter restraining fixture of the
type shown in FIG. 24B can also be used in association with any
pump-assisted leukofiltration system. It should also be appreciated
that a filter restraining fixture 110 can also be used in systems
where blood flow through the leukofilter relies strictly upon
gravity flow.
[0192] The many features of the invention have been demonstrated by
describing their use in separating whole blood into component parts
for storage and blood component therapy. This is because the
invention is well adapted for use in carrying out these blood
processing procedures. It should be appreciated, however, that the
features of the invention equally lend themselves to use in other
blood processing procedures.
[0193] For example, the systems and methods described, which make
use of a programmable cassette in association with a blood
processing chamber, can be used for the purpose of washing or
salvaging blood cells during surgery, or for the purpose of
conducting therapeutic plasma exchange, or in any other procedure
where blood is circulated in an extracorporeal path for
treatment.
[0194] Features of the invention are set forth in the following
claims.
* * * * *