CA2086514A1 - Systems and methods for removing undesired matter from blood cells - Google Patents
Systems and methods for removing undesired matter from blood cellsInfo
- Publication number
- CA2086514A1 CA2086514A1 CA002086514A CA2086514A CA2086514A1 CA 2086514 A1 CA2086514 A1 CA 2086514A1 CA 002086514 A CA002086514 A CA 002086514A CA 2086514 A CA2086514 A CA 2086514A CA 2086514 A1 CA2086514 A1 CA 2086514A1
- Authority
- CA
- Canada
- Prior art keywords
- transfer
- container
- blood
- assembly
- component
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/02—Blood transfusion apparatus
- A61M1/0209—Multiple bag systems for separating or storing blood components
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/02—Blood transfusion apparatus
- A61M1/0209—Multiple bag systems for separating or storing blood components
- A61M1/0218—Multiple bag systems for separating or storing blood components with filters
- A61M1/0222—Multiple bag systems for separating or storing blood components with filters and filter bypass
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0413—Blood
- A61M2202/0427—Platelets; Thrombocytes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0413—Blood
- A61M2202/0429—Red blood cells; Erythrocytes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0413—Blood
- A61M2202/0439—White blood cells; Leucocytes
Abstract
2086514 9220427 PCTABS00017 Systems and methods of collecting blood cells use a first container (16) connected to initially collect blood. A filtration system (14) is provided that uses two flow paths (34, 38), the first (38) being a dual purpose path that is initially used to convey plasma and platelets to a pair of transfer/storage containers (30, 32). A second flow path (34) leads to a temporary transfer container (28) through a filtration device (36). The dual purpose fluid path (38) is next used to convey blood cells, not substantially free of undesired matter, from the temporary storage container (28) to a storage container (18). The filtration system (14) is then detached from the blood collection system (12).
Description
WO 92/20427 ~ PCI /U~92/03~76 ~Y8~E~8 ~ ~1~T~OD8 FOR RE~OVING ~D~:8I~l~D
Ni~TT:13R F~RO~ :BI.OOD C~ S
_iel~ o~ the I~lve~tion:
T~e invention ~enerally relates to blood collec~iorl and processing systems and method~. In a more particular ~ense, the inverltion relates to systems and makhods ~or removing white blood c:ells ~xom red blood cell~ prior to transfusion or long te~n storage.
~S~
l~ost of the whol blood collec:ted from donors today is not itself storad and used for transfu~ion. Instead, the whole blood is ~parated into its clinically proven components ttypically red blsod cells , platelets , and plasma), which are them~;elves individually stored and used to treat a ~ultipl~ciky OI specific conditions and diseased states . For example I the red blood cell compone~t is used to treat anemia; the concentrated plakelet
Ni~TT:13R F~RO~ :BI.OOD C~ S
_iel~ o~ the I~lve~tion:
T~e invention ~enerally relates to blood collec~iorl and processing systems and method~. In a more particular ~ense, the inverltion relates to systems and makhods ~or removing white blood c:ells ~xom red blood cell~ prior to transfusion or long te~n storage.
~S~
l~ost of the whol blood collec:ted from donors today is not itself storad and used for transfu~ion. Instead, the whole blood is ~parated into its clinically proven components ttypically red blsod cells , platelets , and plasma), which are them~;elves individually stored and used to treat a ~ultipl~ciky OI specific conditions and diseased states . For example I the red blood cell compone~t is used to treat anemia; the concentrated plakelet
2 0 component is used to cs:~ntrol thrombt)cytopenic bleeding; an~l the platelet~poo~ plasma component is used as a volume expander or as a ~ource of Clotting Factor VIII ~or the treatment of hemophiliaO
';ystems eomposed of multiple, interconne~cted plastic bags have T~et widespread use ~, .
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W0~2/204~7 P~/U~92/03476 and acceptance in the collectlon, processing and storage of these blood components. In the Ur.ited States, the~e multiple blood bag system6 are subject to regulation by the governmentO For example, the pl~stic materials from which the bags and tubing are made must be approved by the governmen~. In addition, the maximum storage periods for the blood components collected in these systems are prescribed by regulation.
In the United States, whole blood components collected in a nonsterile, or "open", ~ystem (i.e. one that is open to communioation with the atmosphere) must, under governmental regula~ions, b transfused within twenty-~our hours.
However, when wholP blood components are collected in a sterile, or "closedl', system (i.e., one that is closed to communication with the atmo~phere), the red blood cells ca~ b~ stored up to forty-two days (depending upon the type of anticoagulant and storage medium u ed); the platelet concentrate can be stored up to f ive days (depending upon the type of storage container); and the platelet-poor plasma may be ~rozen and stored for even longer p~riods.
Conventional systems of multiple, interconnected plastic bags have met with widespr~ad acceptance, because these systems can reliably provide the desired sterile, "closed" envirsnment ~or ~lood collection and processing, thereby assuring the maximum available storage periods.
: 30 In collecting whole blood components Por trans~usion, it is desirable to minimize th~
; presence o~ impurities or other material~ that may cause undesired side effects in the recipient. For . example, because o~ possible febrile reactions, it is genera:Lly consider~d desirabl to trans~`use red SIJ~TIIU~ SI~ET
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W09~/204~7 PCT/lJS92/03476
';ystems eomposed of multiple, interconne~cted plastic bags have T~et widespread use ~, .
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W0~2/204~7 P~/U~92/03476 and acceptance in the collectlon, processing and storage of these blood components. In the Ur.ited States, the~e multiple blood bag system6 are subject to regulation by the governmentO For example, the pl~stic materials from which the bags and tubing are made must be approved by the governmen~. In addition, the maximum storage periods for the blood components collected in these systems are prescribed by regulation.
In the United States, whole blood components collected in a nonsterile, or "open", ~ystem (i.e. one that is open to communioation with the atmosphere) must, under governmental regula~ions, b transfused within twenty-~our hours.
However, when wholP blood components are collected in a sterile, or "closedl', system (i.e., one that is closed to communication with the atmo~phere), the red blood cells ca~ b~ stored up to forty-two days (depending upon the type of anticoagulant and storage medium u ed); the platelet concentrate can be stored up to f ive days (depending upon the type of storage container); and the platelet-poor plasma may be ~rozen and stored for even longer p~riods.
Conventional systems of multiple, interconnected plastic bags have met with widespr~ad acceptance, because these systems can reliably provide the desired sterile, "closed" envirsnment ~or ~lood collection and processing, thereby assuring the maximum available storage periods.
: 30 In collecting whole blood components Por trans~usion, it is desirable to minimize th~
; presence o~ impurities or other material~ that may cause undesired side effects in the recipient. For . example, because o~ possible febrile reactions, it is genera:Lly consider~d desirabl to trans~`use red SIJ~TIIU~ SI~ET
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W09~/204~7 PCT/lJS92/03476
- 3 ~ ;~0~'-'jl l blood cells su~stantially ~ree of the white hlood cell components, particularly for rPcipients who undergo frequent transfusions.
One way to remove white blood cells is by washing the red blood cells with saline. This technique is time con~uming and inefficierlt, as it can reduce the number of red blood cells available ~or transfusion. The washing process al~o expos~s the red blood cells to co~munication with the atmosphere, and thereby constitutes a "non~sterile"
entry into the storage sys~em. Once a non-sterile entry is made in a previously closed system, the system i5 consldered "opened", and transfusion must occur within twenty-four hours, regardless of the lS manner in which the blood was collected and proces~ed in the first plaoe. In the United States, an entry into a blood collection system that presents the probability of non-sterility that exceeds one in a million is generally considered to con~titute a "non-sterile" entryO
Another way to r~move white blood cells is by ~iltration. Systems and methods for accomplishing this within the context of conventional multiple blood bag configurations are described in Wisdom U.S. Patents 4,596,657 and
One way to remove white blood cells is by washing the red blood cells with saline. This technique is time con~uming and inefficierlt, as it can reduce the number of red blood cells available ~or transfusion. The washing process al~o expos~s the red blood cells to co~munication with the atmosphere, and thereby constitutes a "non~sterile"
entry into the storage sys~em. Once a non-sterile entry is made in a previously closed system, the system i5 consldered "opened", and transfusion must occur within twenty-four hours, regardless of the lS manner in which the blood was collected and proces~ed in the first plaoe. In the United States, an entry into a blood collection system that presents the probability of non-sterility that exceeds one in a million is generally considered to con~titute a "non-sterile" entryO
Another way to r~move white blood cells is by ~iltration. Systems and methods for accomplishing this within the context of conventional multiple blood bag configurations are described in Wisdom U.S. Patents 4,596,657 and
4,767,541, as well as in Carmen et al U.S7 Patent~
4,810,378 and 4,855,063. In these arrangements, an inline white blood call filtration device is used.
The filtration can thereby he accomplished in a closed system. How~ver, the filtration processes associated with the~e arrangements r~uire the extra step of wetting the filtration device before use with a red blood ~ell additive solution or the like.
. This adde~ ~tep complicates the filtration process and incr~as~s the processing time.
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Other syste~s and methods for removing white blood cells in the context of closed, multiple blood ba~ confisurations are described in Stewart U.S. Patent 4,997,577. In these filtration systems and methods, a transfer assembly dedicated solely to the removal of white blood cells is used. The transfer assembly is attached to a primary blood collection container. The transfer assembly has a transfer container and a first fluid path leading to the transfer container that includes an inline device for separating white blood cells from red blood cells. The transfer asse~bly also has a second fluid path tha~ bypasses the separation device. U~ing these systems and methods, white blood cells are removed as the red blood cells are conveyed to the transfer container through the fir~t fluid path. The red blood cells, now substantially free of white blood cells, are then conveyed ~rom the transfer container back to the primary collection container for storage through the second fluid path, this time bypassing the ~eparation device.
A need still exists fGr further improved systems and methods for removing undesired matter from blood components prior to trans~usion or storage in a way that lends itself to use in closed multipl~ blood bag system environments.
~u~a_Y of th~ ~e~tio~:
The invention provides a ml~ltiple container blood collection system ~or conveniently processing all the various components of blood. The system includes a device for ~eparating undesired matter ~rom some of the components prior to storage. The system is ~rranged so that only single pass through t:he separation device is required during a SlLqBSTlT~ S~EÇI~
.
.
W~92/20427 ~'~/US92/~3476 _ 5 given proc~ssing sequence.
In one embodiment, the sy~tem comprises a blood collection assembly ancl an associated transPer assembly having first and second transfer 5containers.
~o transfer paths lead to the first transfer container. The ~irst trans~er path includes means for separating undesired matter from blood. A second transfer path bypasses the 10sep~ra~ion means.
third transfer path leads to the second transfer container. The third path communicates with the second transfer path, also bypassing the separation means that is present in the first 15transfer path.
The system also includes means for establishi~g communication between the blood collection assembly and the first, second and third transfer paths.
20In this arrangement, the sy~tem includes flow control means that is operable in thr~e modes:
(i) In its first mode, the flow control means directs a first quantity of blood ~rom . the blood collection assembly for collection in the ; 25second txansfer container through the second and third transfer paths, therefore bypassing the separation means. In this way, a ~irst quantity o~
blood can be freçly and easily transferred within the ~ystem without being passed through the 30separation means.
(ii~ In its s~cond mode, the flow control means direct~ a second quantity of blood fr~m the blood collection assembly to the first transfer container through the first transfer path.
35In this way, the second quantity of blood can be ~IT~
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.
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wog2/2o427 ~'C~IU~9~/03476 s 1 Q~
passed through the separakion means for removal of the undesirable matter.
(iii) In its khlrd mode, the flo~l control means directs the second quantlty of blood ~now substantially free of undesired matter) from the first transfer contain,er back to the blood collection a~sembly for storage. This transfer occurs thxough the second flow path, thereby bypassing the separation means. In this way, blood previously freed of undesired matter can be easily transferred back to the blood collection system for storage without being unnecessarily subjected to a second pass through the separation means.
In a preferred arrangement, the blood collection assembly includes a satellite bag which contains an additive solu~ion for the blood that is to be stored free of undesired mattex. In this arrangement, the ~low control means is operative in a fourth mode for directing the additive solution from the satellite bag to the primary container through a path that bypasses the separation m~ans.
The additive solution is added to a blood component prior to its being pas~ed through the separation device. As in the other arrangements, the system faciiitates multiple blood component processing with only a single pass through the inline separation means.
In a pre~erred embodiment, the blood collection assembly and the transfer assembly comprise separate closed subassemblies. In this arrangemenk, the means for establishing communication includes means for attachiny khe ~lood collection subassembly to the transfer subassembly without ot:herwise opening the closed subassemblies t~ communi.cation with the atmosphere.
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, W~92/204~7 P~/U~92/~3~76 ~ 7 2~
The invention alsc) provides methods o~
collecting blood components substantially free of undesired matter usin~ the systems as just generally describ~d.
Other feature~ and advantages of the invention will become apparent upon review of the following description, drawings, and appended claims~
Brief Des~riptio~ of t~e Dr~win~:
Fig. 1 is a schematic view of a blood collection system that includes a blood processing assembly and a transfer assembly that embody the f2atures of t~e invention;
Fig. 2 is a schematic view of the system lS shown in Fig. 1, with the blood transfer assembly attached to the blood processing assembly showing transfer of plasma and platelet componsnts to a transfer container;
Fig. 3 is a schematic view of the system shown in Fig. 1, ~howing ~iltration o~ the red blood cells to remove unde~ired matter, with the platelet and plasma being independently processed in a separate subassembly;
Fig. 4 is a schematic view o~ the system shown in Fig. 1, showing the return of the ~iltered blood cells to the collection assembly for storlge;
; ~ig. 5 is a sche~atic vi~.w of the 8y5t .m shown in Fig. 1 with tha container holding the filtered blood separated from the system ~or storage;
Fig. 6 is a schematic view o~ another blood collection system that :includQs a blood processing ass~mbly a.nd a transfer assembly that embody the features oi` the invention; and Fig. 7 is an enlarged side sectional view SlJ~STiTlJT~ S~ET
.: . ~ . . . : .
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W092/~427 Pcr/us~2/
~ 3~ 8 -of the sterile connection devices associated with the systems shown in Figs. 1 iand 6.
D~s~riptio~ o tho Pr~ferre~ Embo~i~ent~:
A blood collection system 10 that embodi~s the features of the invention is shown in Fig. 1.
The system 10 comprises a blood collection assemhly 12 and a tra~sfer assembly 14.
In use, the assambly 12 serves to initially collect a unit o~ blood from a donor and to allow conventional centri~u~al separation of the blood into at least two component parts. The assembly 12 serYes to process the blood into first and second component parts. In use, the assembly 14 also serves to allow the separation of unde~ired matter from the second component prior to the storage.
In the embodiment shown in Fig. 1, the transfer assembly 14 ~omprises an initially separate subassembly that is not joined to the blood processing assembly 12. In this arrangement, the assembly 12 also becomes an initially separate subassembly.
According to the invention, prior to usP, the separate transfer subassembly 14 need not contain any fluids, stora~e mediums, and the like (except ~or any entrapped air). Preferably, all : such fluids are contained in the blood collection subassembly 12 prior to use. The invention thus provides the capability o~ having a blood collection system lO compvsed of a fluid containing (or ~Iwet~) subassembly 12 and a Pluid ~ree (or "dry") subassembly 14. This arrangement serves to avoid the application of the regulatory requirements governing fluid-containing systems upon the transfer assemhly 14O It should be appreciated, however, that the transfer assembly 14 can be made as an ~ TITI~ ~ FT
.
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W092/20427 PCr/US~2/03476 g ~3~
integral part of the assembly 12 and/or, if desired, con~ain fluids.
In the embodiment shown in Fig. 1, the bl~od collection and storage subassembl~ 12
4,810,378 and 4,855,063. In these arrangements, an inline white blood call filtration device is used.
The filtration can thereby he accomplished in a closed system. How~ver, the filtration processes associated with the~e arrangements r~uire the extra step of wetting the filtration device before use with a red blood ~ell additive solution or the like.
. This adde~ ~tep complicates the filtration process and incr~as~s the processing time.
, :
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.
.
. . . .
.
. , ..
W092/20427 PCT/~Ss2/03~7~?
Other syste~s and methods for removing white blood cells in the context of closed, multiple blood ba~ confisurations are described in Stewart U.S. Patent 4,997,577. In these filtration systems and methods, a transfer assembly dedicated solely to the removal of white blood cells is used. The transfer assembly is attached to a primary blood collection container. The transfer assembly has a transfer container and a first fluid path leading to the transfer container that includes an inline device for separating white blood cells from red blood cells. The transfer asse~bly also has a second fluid path tha~ bypasses the separation device. U~ing these systems and methods, white blood cells are removed as the red blood cells are conveyed to the transfer container through the fir~t fluid path. The red blood cells, now substantially free of white blood cells, are then conveyed ~rom the transfer container back to the primary collection container for storage through the second fluid path, this time bypassing the ~eparation device.
A need still exists fGr further improved systems and methods for removing undesired matter from blood components prior to trans~usion or storage in a way that lends itself to use in closed multipl~ blood bag system environments.
~u~a_Y of th~ ~e~tio~:
The invention provides a ml~ltiple container blood collection system ~or conveniently processing all the various components of blood. The system includes a device for ~eparating undesired matter ~rom some of the components prior to storage. The system is ~rranged so that only single pass through t:he separation device is required during a SlLqBSTlT~ S~EÇI~
.
.
W~92/20427 ~'~/US92/~3476 _ 5 given proc~ssing sequence.
In one embodiment, the sy~tem comprises a blood collection assembly ancl an associated transPer assembly having first and second transfer 5containers.
~o transfer paths lead to the first transfer container. The ~irst trans~er path includes means for separating undesired matter from blood. A second transfer path bypasses the 10sep~ra~ion means.
third transfer path leads to the second transfer container. The third path communicates with the second transfer path, also bypassing the separation means that is present in the first 15transfer path.
The system also includes means for establishi~g communication between the blood collection assembly and the first, second and third transfer paths.
20In this arrangement, the sy~tem includes flow control means that is operable in thr~e modes:
(i) In its first mode, the flow control means directs a first quantity of blood ~rom . the blood collection assembly for collection in the ; 25second txansfer container through the second and third transfer paths, therefore bypassing the separation means. In this way, a ~irst quantity o~
blood can be freçly and easily transferred within the ~ystem without being passed through the 30separation means.
(ii~ In its s~cond mode, the flow control means direct~ a second quantity of blood fr~m the blood collection assembly to the first transfer container through the first transfer path.
35In this way, the second quantity of blood can be ~IT~
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.
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.
.
. . . .
wog2/2o427 ~'C~IU~9~/03476 s 1 Q~
passed through the separakion means for removal of the undesirable matter.
(iii) In its khlrd mode, the flo~l control means directs the second quantlty of blood ~now substantially free of undesired matter) from the first transfer contain,er back to the blood collection a~sembly for storage. This transfer occurs thxough the second flow path, thereby bypassing the separation means. In this way, blood previously freed of undesired matter can be easily transferred back to the blood collection system for storage without being unnecessarily subjected to a second pass through the separation means.
In a preferred arrangement, the blood collection assembly includes a satellite bag which contains an additive solu~ion for the blood that is to be stored free of undesired mattex. In this arrangement, the ~low control means is operative in a fourth mode for directing the additive solution from the satellite bag to the primary container through a path that bypasses the separation m~ans.
The additive solution is added to a blood component prior to its being pas~ed through the separation device. As in the other arrangements, the system faciiitates multiple blood component processing with only a single pass through the inline separation means.
In a pre~erred embodiment, the blood collection assembly and the transfer assembly comprise separate closed subassemblies. In this arrangemenk, the means for establishing communication includes means for attachiny khe ~lood collection subassembly to the transfer subassembly without ot:herwise opening the closed subassemblies t~ communi.cation with the atmosphere.
... . . .
:' , : .
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: :
, W~92/204~7 P~/U~92/~3~76 ~ 7 2~
The invention alsc) provides methods o~
collecting blood components substantially free of undesired matter usin~ the systems as just generally describ~d.
Other feature~ and advantages of the invention will become apparent upon review of the following description, drawings, and appended claims~
Brief Des~riptio~ of t~e Dr~win~:
Fig. 1 is a schematic view of a blood collection system that includes a blood processing assembly and a transfer assembly that embody the f2atures of t~e invention;
Fig. 2 is a schematic view of the system lS shown in Fig. 1, with the blood transfer assembly attached to the blood processing assembly showing transfer of plasma and platelet componsnts to a transfer container;
Fig. 3 is a schematic view of the system shown in Fig. 1, ~howing ~iltration o~ the red blood cells to remove unde~ired matter, with the platelet and plasma being independently processed in a separate subassembly;
Fig. 4 is a schematic view o~ the system shown in Fig. 1, showing the return of the ~iltered blood cells to the collection assembly for storlge;
; ~ig. 5 is a sche~atic vi~.w of the 8y5t .m shown in Fig. 1 with tha container holding the filtered blood separated from the system ~or storage;
Fig. 6 is a schematic view o~ another blood collection system that :includQs a blood processing ass~mbly a.nd a transfer assembly that embody the features oi` the invention; and Fig. 7 is an enlarged side sectional view SlJ~STiTlJT~ S~ET
.: . ~ . . . : .
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W092/~427 Pcr/us~2/
~ 3~ 8 -of the sterile connection devices associated with the systems shown in Figs. 1 iand 6.
D~s~riptio~ o tho Pr~ferre~ Embo~i~ent~:
A blood collection system 10 that embodi~s the features of the invention is shown in Fig. 1.
The system 10 comprises a blood collection assemhly 12 and a tra~sfer assembly 14.
In use, the assambly 12 serves to initially collect a unit o~ blood from a donor and to allow conventional centri~u~al separation of the blood into at least two component parts. The assembly 12 serYes to process the blood into first and second component parts. In use, the assembly 14 also serves to allow the separation of unde~ired matter from the second component prior to the storage.
In the embodiment shown in Fig. 1, the transfer assembly 14 ~omprises an initially separate subassembly that is not joined to the blood processing assembly 12. In this arrangement, the assembly 12 also becomes an initially separate subassembly.
According to the invention, prior to usP, the separate transfer subassembly 14 need not contain any fluids, stora~e mediums, and the like (except ~or any entrapped air). Preferably, all : such fluids are contained in the blood collection subassembly 12 prior to use. The invention thus provides the capability o~ having a blood collection system lO compvsed of a fluid containing (or ~Iwet~) subassembly 12 and a Pluid ~ree (or "dry") subassembly 14. This arrangement serves to avoid the application of the regulatory requirements governing fluid-containing systems upon the transfer assemhly 14O It should be appreciated, however, that the transfer assembly 14 can be made as an ~ TITI~ ~ FT
.
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W092/20427 PCr/US~2/03476 g ~3~
integral part of the assembly 12 and/or, if desired, con~ain fluids.
In the embodiment shown in Fig. 1, the bl~od collection and storage subassembl~ 12
5 comprises a blood bag system having a primary bag or container 16 and a satellite bag or container 18 attached to the primary ]bag 16 ~y integrally attached tubing 200 In use, the primary bag 16 ~which is also 10 called a donor bag) receives whole blood ~rom a donor through integrally attached donor tubing 22 that carrie5 an phlebotomy needle 24. A suitable anticoagulant A is contained in the primary bag 16.
The whole blood is æeparated by 15 conventional centrifugation techniques within the primary bag 16 into a red blood cell component and a platelet-rich plasma component. During such separation techniques, a layer of white blood cells (commonly called the "buffy coat"~ forms between the 20 red blood cells and the platelet-rich plasma.
The tu~ing 20 that integrally connectq the bags 16 and 18 is also joined to an outlet branch tubing 26 for connection to the transfer subassembly 14~
The trans~er assembly 14 includes several trans~er bags or containers 28, 30, and 32. The transfer bag 28 is intended to receiv2 red blood cells in the course of removing white blood calls from the recl blood cells prior to storage. The 30 trans~er containers 30 and 32 are intended to : accommodate the separation of the platelets ~rom ths platelet-r:ich plasma and ko ultimately store the resulting plat~let-poor plasma and concentrat~d pl~telet compone~ts.
In the illustrated embodiment, the transfer St~ll~ ~IE~T
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W092/20427 PCT/US92/0347h bag 32 ultimately serves as the storage container for the platelet concentrate, and the transfer bag 30 ultimately serves as the storage container for the platelet-poor plasma.
The transfer a~sembly 14 includes a first transfer path 34 that leads to the trans~er container 28. The path 34 includes a device 36 for separating undesired matter cells from blood~
It should be appr~ciated that the transfer lo assembly 14 can be used to remove all types of undesired materials from dif~erent types blood cells, depending upon its particular construction.
In the illustrated embodiment, the assembly 14 is intended to remove whit~ blood cells (and preferably also platelets) from the red blood cells prior to ætorage. In this arrangement, the separation device 36 includes a housing 42 containing a conventional filtration medium 44 suitad for the ramoval of white blood cells and platelets fr~m red blood cells. The filtration medium 44 can include cotton wool, cellulose acetate or another synthetic fiber like polyest~r.
It should also be appr~ciated that separation can occur by various centrifugal and non-centrifugal techniques, and not merely ~'~iltration"
in the technical sense. Separation can occur by .absorption, columns, chemical, electrical, and electromagnetic means. The term "separation device"
is broadly used in this specification encompa~s all of these separation techniques as well.
The transfer assembly 14 ~urther includes a second trans~er path 38 that also leads to the transfer contEIiner 28. However, unlike the transfer path 34, this ~ran~r path 38 bypasses the 35 separation d8YiC2 3 6 .
i .
W0~2/20~27 PCT/US')2/03~76 2a.~s~
The transfer assembly 14 also includes a third transfer path 40 that communicates with the second transfer path 38. The third path 40 leads to the transfer container 32, byp~s~ing the separation device 36.
Because o~ this construction, it is possible to selectively direct fluid within the system 10 into and out of the containers 2~, 30, and 32 in paths that either pass khrough the separatlon device 36 (i.e., via the fluid path 34~ or bypass the separation device 36 (i.e., via the fluid path 38).
The assembly 14 can be variously constructed. In the illustrated embodiment, fluid path 34 takes the form of a length o~ flexible tubing 56. The ~ubing 56 includes first and second opposite end portions 56A and 56B. The tubing end 56B is connected to th~ transfer container 28. The separation device 36 i~ located inline bQtween the opposite end portions 56A and 56B.
In this arrangemen~, the ~luid path 38 also include a length o~ flexible tubing 58. One end 58A joins the first ~luid path tubing 56 between tubing end 56A and the separation device 36. The other end 58B joins the ~irst fluid path tubing 56 between the separation device 36 and the tubing end 56B.
In this arrangement, the ~luid path 40 also includes a l~ngth of flexible tubing 60. One end 60A is connected to the trans~8r container 32. The other end 60B joins the tubing 56 between its junction with tubing end 58B and its tubiny end 56B.
A len~th o~ ~lexible tubing 62 attached to the trans~er container 30 joins the tubing 60 between ! 3 5 tubing end~ 6OA and 6OB.
.
~TITUTE $~ET
.
. ` . .. . . .
, ,. . . .
, . ~ . . , .. -. , ~ . .
.
- . ~. ~ .
I .. . .
~ ... . . .. ... .
W092/20~27 PCr/US92/03475 '2 ~ 8 j 1 i~
The transfer a~sembly 14 includes flow control means for directing fluid flow between the collection subassembly 12 ancl the various paths 34, 28, and 40 of the transfer subassembly 14. In the illustrated embodiment, the flow control means comprise a series of conventional roller clamps 46 to 54 arranged as shown in Fig. 1. By selectively opening and closing the roller clamps 46 to 54, the system 10 can he selectively placed by the user in different processing modes.
A first processing mode directs a first quantity of blood from the assembly 12 for collection in the transfer container 32 via the second and third transfer paths 38 and 40. The first quantity of collected blood thereby bypasses the separation device 36.
A second processing mode directs a second quantity of blood from the assembly 12 to the transfer container 28 via the ~irst transfer pa$h 34. The second quantity of blood thereby passes through the s~paration devic2 36 to remove the undesired materials. This mode is intended to be us~d to remove und~sired matter from those ; components prior t~ storage.
A third mode directs the second quantity o~
blood from the transfer container 28 back to the : assembly 12 via the second flow path 38 for storage, thereby bypassing the separation device 36. This mode avoicl~ the unnecessary return of filtered components bac~ throuqh th~ separation device 36.
The bags and transfer paths associat~d with the assemblies 12 and 14 can be made from , conventional approved medical grade plastic : ~aterials, such as polyvinyl chloride plasticized with d:i-2-ethyl~hexylphthalate (DEHP).
SUBSTITUTE SHEE~T
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~O9~/204~7 Pcrluss~/
- 13 - ~,s'~
Alternatively, transfer container 32, which i5 intended to store the platelet concentrate, can be made of polyolefin material (as disclosed in Gajewski et al u.s. Patent 4,~.40,162~ or a polyvinyl chloride material plasticized with tri-2-ethylhexyl trimellitate (TEHTH). These materials, when compared to DEHP-plasticized polyvinyl chloride materials, have greater gas permeability ~hat is beneficial for platelet storage.
The system 10 includes a means ~or connecting the initially separate subassemblies 12 and 1~ together for use. The connection means is associated with each of the initially separate a~semblies 12 and 14. The connection means permits selective attachment of the transfer assembly 14 to the blood collection assembly 12 (as shown in Fig.
2).
In the embodiment shown in Fig. 1, the connection means comprises two mating ~terile connection devices (deslgnated 66a and 66b). The devices 66a and 66b (see also Fig. 7) are described in Granzow et al U.S. Patents 4,157,723 and ~,265,280, which are incorporated herein by re~erence. One device 66a i~ carried by the outlet branch 26 of the assembly 12. The other device 66b is carried at the tubing end 56A of the transfer assembly 14.
As shown in Fig. 7, the sterile connection devices 66a and 66b each generally includes a housing 70 having a normally closed, meltable wall 72 made o~ a radiant energy absorbing material. The housings 70 are joined together with mating bayonet-type couplers 74a and 74b/ with the walls 72 placed in facing contact. When connected and exposed to radiant energy, the walls 72 melt at temperatures SU8S~ITUTE S~ET
,.. .. .. . , , ... ... ,., , : : . .
. .. . .. .. . . . ~ , . . .
.. . ~ . . . . . . . .
.... . . . . : .. ~ ~ .:
. . . . . .
.. . . . . ... .
. . . . . . .
. . ~. . . ~
.... ~
.
W092/2U4~7 PCr/US~2/03~7 that result in the destruction of bacteria, while at the same time opening a f:luid path between the connected housings 70~
The devices 66a and 66b normally close the associated assembli~s 12 and. ~4 from communication with the atmosphere and are opened in conjunction with an active sterilizatioll step which serves ~o sterilize the regions adjacent to the interconnecting fluid path as the ~luid path is being formPd. These devices 66a and 66b also hermetically seal the interconnecting fluid path at the time it is formed. The use of these sterile connection devices 66a and 66b assures a probability of non-sterility that exceeds one in a million. The devices 66a and 66b thus serve to connect the two assemblies 12 and 14 without compromising the sterile integrity of either.
Alternately, the connection means can comprise the sterile connecting system disclosed in Spencer U.SO Patent 4,412,835 (not shown). In this arrangement, this system forms a molten seal between the tuhing end 26 and 56A. Once cooled, a sterile weld is formed.
The assemblies 12 and 14, once sterilized, each consti~utes a sterile, "closed" system, as jl~dged by the applicable standards in the Vnitad States.
In use, whole blood is collected (via the donor tube 22) in the primary bag 16. The collected whol~ blood is then separated within the primary bag 16, preferably by centrifuging, into red blood cells (RBC) and platelet~rich plasma (PRP). An intermediate white ~lo~d cell layer (BC~ also forms.
Th~ assembly 12 i5 next joined to the assembly 14 (as Fig. 2 shows). The flow control $~;TIT~ ~EET
, . . .
~ . . , . :
:: , .: ~ , ...
W092/20427 PCT/US92/03~76 means is placed into its fi~.st processing mode by closing clamps 47; 48; 50; ~nd 54 (if previously opened) and by openi.ng clam]ps 46; 49; and 52 (if previously closed).
The platelet-rich plasma ~PRP) is conveyed from the primary bag 16 through second and third transfer paths 38 and 40 by con~entional techniques (for example by using a plasma expresser) into the transfer bag 32. In this step, attempts are made to leave all the red blood cells and as many white blood cells as possible in the primary bag 16. The handling of the platelet-rich components in this way avoids use of the separation device 36.
The clamp 52 is closed, and the transfer bags 30 and 32 are detached in a sterile fashion (as Fig. 3 shows). The detachment can be accomplished using a conventional heat sealing device (~or example, the Hematron~ dielectric sealer sold by Baxter Healthcare Corporation~, which forms a hermetic, snap-apart seal in the tubing 60 ~this seal is schematically shown by an "x" in Fig. 3 ~.
The donor tubing 22 is preferably sealed and disconnected in the same fashion (as shown in Fig.
2) before joining the two assemblies 12 and 14 together.
As Fig. 3 also shows, the platelet rich pla~ma can undergo subsequent centrifug~l separation within the transfer bag 32 into platelet concentrate (designated PC in Fig. 3) and platelet-poor plasma 3C (desi~nated PPP in Fig~ 3~. By opening clamp 54, the platelet-poor plasma (PPP) is transferred in~o the bag 30 ~or storage, leaYing the platelet concentrat~e in the bag 32. The transfer bags 30 and 32 are then separated by the snap-apart seals "x" in the ~ubing 32 (as shown in Fig. 3) ~or subsequent ~IU~5Tl~lJTE S'~
,. , ., ~ , . . .
: .
.
. .. . . .
.
WO9~/20427 pcr/lJs92/o34~L6 '~ ~J ~
storage as individual components.
The flow control mealls is next placed into its second processing mode to transfer the red blood cells ~with associated white blood cells) to the transfer container 28 via the separation device 36.
In the illustrat~d embodiment, th~
satellite container 18 holdr= a suitablP storage solution 5 for red blood cel].s. One such solution is disclosed in Grode et al U~S. Patent 4~267,269.
In this arrangement, prior to assuming the second processing mode, the flow control means is ~irst placed into a processing mode for directing the additive solution S from the satellite bag ~8 to the primary bay in a path that bypasses the separation device 36. This mode is ascomplished by closing clamp 48 and opening clamps 46 and 47. The solution A is transferred to th~ primary bag 16 via path ~0.
The second processin~ mode then proceeds by : closing clamps 47 and 49 and opening olamp 48. As shown in Fig. 3, the primary bag 16 is li~ted above the transfer bag 28, and the red blood cells (with associated white blood cells and additive solution S) are conveyed by gravity flow ~rom the bag 16 through the fluid path 34 and separation device 36 into the transfer bag 28. The undesired matter (i.e., white blood cells and platelets) are removed ~rom thQ red blood cells by the separ~tion device 36.
~hile th~ two assemblies 12 and 14 are still attached together, the flow control means is placed in i.t5 third mode, as Fig~ 4 shows. This is accomplishe.d by closing clamp ~8 and opening clamp 49, The transfer b~g 28 is li~ted above assembly 12. The re.d blood cells and additive solution, now substantially ~ree of the undesired white blood . ~ .
W~92/204~7 PCT/U~')2/03~7 ~ i ~ 3 . i cells, are. returned by gravity flow from the transfer bag 28 through the fluid path 38, bypassing the separation device ~6.
The filtered red blood cells can be returned for storage either to the pri~ary bag 16 (by opening clamp 46 and closing clamp 47~ or to the now empty satellite bag 18 (by closing clamp 46 and opening clamp 47). In the illustrated and preferred embodiment, the filtered r~d blood cells are conveyed to the satellite bag 18 for storage.
Should air be trapped in ~he transfer bag 28, it may be necessary to first transfer the air through bypass path 38 into the bag 16 or 18 in which the red blood cells will not be ultimately returned for storage.
As Fig. 5 shows, the satellite bag : containing the filtered red blood cells and additive solution is detached ~rom the blood collection assembly 12 for storage.
In one alternatiYe arrangement (not shown~, the assembly 12 could be made without an associated satellite bag 18. In this arrangement, the red blood cells are returned to the primary bag 16 for storage after filtration.
In another alternative arrangement tal60 not shown), the assembly 12 could include an associat d empty satellite bag9 without an additive solution. In this arrangement, the red blood cells are return~d to the satellite bag aPter filtration ~or ~torage :Eree o~ an additive ~olution.
Yet another alternative arrangement is shown in Fiy. 6. In this embodiment, like the embodiment shown in Fig. 1, the assembly 12 inoludes a primary bag 16 and a satellite bag 18. Also like the embodi.ment shown in Fig. 1, the a~sembly 14 .
,. , . . -.
, , ' ' :
W092/20427 P~T/lJ~2/03~7..6 includes a transfer container 28 with two associated flow paths 34 and 38, one 34 which includes ~he separation device 36, one 38 which does not.
Unlike the Fig. 1 embodiment, the transfer bags 30 and 32 are not associated with the assembly 14, but instead form an integral part of the assembly 12.
In using the embodiment shown in Fig. 6, whole blood i5 collected in the donor bag 16, where it is separated into red blood cells, platelet-rich plasma, and white blood cells in the manner already described in the Fig. 1 embodiment. In its first processing mode, the platelet-rich plasma is conveyed to the transfer bag 32 for processing.
Like the Fig. 1 embodiment, th~ path between the primary bag 16 and the transfer bags 30 and 32 bypasses the separation dPvice 36O
The transfer bag~ 30 and 32 are then detached from th assembly 12 in the manner previously described with respect to assembly 14.
The assembly 12 is then attached to the assembly 14, and the processing through $he remaining modes proceeds as previously described.
In the illustrated embodiments, the entire filtration proce~s (including the attachme~t and detachment of the assemblies 12 and 14) can be accomplished in less than five minutes. All blood components processed are subqtantially ~ree o~ the undesired matter~ In the preferred embodiment, where the all the fluid trans~ers are made using ~terile connection techniques, the processing and inline filt3-ation have occurred without compromising the.sterile integrity of any collected compon~nt or reducing their storage life.
: 35 Various modifications of the invention will SW~TIT~ S~~
.
. : . . : . .
. . . --_, -. . .
.
.~ .
~ 92/20427 PCI/US92/03~76 be apparent to those skilled in the art within the purview of the following claims.
' ' ~
.
SUBSlTrU~ SH~E~
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The whole blood is æeparated by 15 conventional centrifugation techniques within the primary bag 16 into a red blood cell component and a platelet-rich plasma component. During such separation techniques, a layer of white blood cells (commonly called the "buffy coat"~ forms between the 20 red blood cells and the platelet-rich plasma.
The tu~ing 20 that integrally connectq the bags 16 and 18 is also joined to an outlet branch tubing 26 for connection to the transfer subassembly 14~
The trans~er assembly 14 includes several trans~er bags or containers 28, 30, and 32. The transfer bag 28 is intended to receiv2 red blood cells in the course of removing white blood calls from the recl blood cells prior to storage. The 30 trans~er containers 30 and 32 are intended to : accommodate the separation of the platelets ~rom ths platelet-r:ich plasma and ko ultimately store the resulting plat~let-poor plasma and concentrat~d pl~telet compone~ts.
In the illustrated embodiment, the transfer St~ll~ ~IE~T
- ` .
W092/20427 PCT/US92/0347h bag 32 ultimately serves as the storage container for the platelet concentrate, and the transfer bag 30 ultimately serves as the storage container for the platelet-poor plasma.
The transfer a~sembly 14 includes a first transfer path 34 that leads to the trans~er container 28. The path 34 includes a device 36 for separating undesired matter cells from blood~
It should be appr~ciated that the transfer lo assembly 14 can be used to remove all types of undesired materials from dif~erent types blood cells, depending upon its particular construction.
In the illustrated embodiment, the assembly 14 is intended to remove whit~ blood cells (and preferably also platelets) from the red blood cells prior to ætorage. In this arrangement, the separation device 36 includes a housing 42 containing a conventional filtration medium 44 suitad for the ramoval of white blood cells and platelets fr~m red blood cells. The filtration medium 44 can include cotton wool, cellulose acetate or another synthetic fiber like polyest~r.
It should also be appr~ciated that separation can occur by various centrifugal and non-centrifugal techniques, and not merely ~'~iltration"
in the technical sense. Separation can occur by .absorption, columns, chemical, electrical, and electromagnetic means. The term "separation device"
is broadly used in this specification encompa~s all of these separation techniques as well.
The transfer assembly 14 ~urther includes a second trans~er path 38 that also leads to the transfer contEIiner 28. However, unlike the transfer path 34, this ~ran~r path 38 bypasses the 35 separation d8YiC2 3 6 .
i .
W0~2/20~27 PCT/US')2/03~76 2a.~s~
The transfer assembly 14 also includes a third transfer path 40 that communicates with the second transfer path 38. The third path 40 leads to the transfer container 32, byp~s~ing the separation device 36.
Because o~ this construction, it is possible to selectively direct fluid within the system 10 into and out of the containers 2~, 30, and 32 in paths that either pass khrough the separatlon device 36 (i.e., via the fluid path 34~ or bypass the separation device 36 (i.e., via the fluid path 38).
The assembly 14 can be variously constructed. In the illustrated embodiment, fluid path 34 takes the form of a length o~ flexible tubing 56. The ~ubing 56 includes first and second opposite end portions 56A and 56B. The tubing end 56B is connected to th~ transfer container 28. The separation device 36 i~ located inline bQtween the opposite end portions 56A and 56B.
In this arrangemen~, the ~luid path 38 also include a length o~ flexible tubing 58. One end 58A joins the first ~luid path tubing 56 between tubing end 56A and the separation device 36. The other end 58B joins the ~irst fluid path tubing 56 between the separation device 36 and the tubing end 56B.
In this arrangement, the ~luid path 40 also includes a l~ngth of flexible tubing 60. One end 60A is connected to the trans~8r container 32. The other end 60B joins the tubing 56 between its junction with tubing end 58B and its tubiny end 56B.
A len~th o~ ~lexible tubing 62 attached to the trans~er container 30 joins the tubing 60 between ! 3 5 tubing end~ 6OA and 6OB.
.
~TITUTE $~ET
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. ` . .. . . .
, ,. . . .
, . ~ . . , .. -. , ~ . .
.
- . ~. ~ .
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~ ... . . .. ... .
W092/20~27 PCr/US92/03475 '2 ~ 8 j 1 i~
The transfer a~sembly 14 includes flow control means for directing fluid flow between the collection subassembly 12 ancl the various paths 34, 28, and 40 of the transfer subassembly 14. In the illustrated embodiment, the flow control means comprise a series of conventional roller clamps 46 to 54 arranged as shown in Fig. 1. By selectively opening and closing the roller clamps 46 to 54, the system 10 can he selectively placed by the user in different processing modes.
A first processing mode directs a first quantity of blood from the assembly 12 for collection in the transfer container 32 via the second and third transfer paths 38 and 40. The first quantity of collected blood thereby bypasses the separation device 36.
A second processing mode directs a second quantity of blood from the assembly 12 to the transfer container 28 via the ~irst transfer pa$h 34. The second quantity of blood thereby passes through the s~paration devic2 36 to remove the undesired materials. This mode is intended to be us~d to remove und~sired matter from those ; components prior t~ storage.
A third mode directs the second quantity o~
blood from the transfer container 28 back to the : assembly 12 via the second flow path 38 for storage, thereby bypassing the separation device 36. This mode avoicl~ the unnecessary return of filtered components bac~ throuqh th~ separation device 36.
The bags and transfer paths associat~d with the assemblies 12 and 14 can be made from , conventional approved medical grade plastic : ~aterials, such as polyvinyl chloride plasticized with d:i-2-ethyl~hexylphthalate (DEHP).
SUBSTITUTE SHEE~T
, ' :
~, .
.:, `
: . . .
~O9~/204~7 Pcrluss~/
- 13 - ~,s'~
Alternatively, transfer container 32, which i5 intended to store the platelet concentrate, can be made of polyolefin material (as disclosed in Gajewski et al u.s. Patent 4,~.40,162~ or a polyvinyl chloride material plasticized with tri-2-ethylhexyl trimellitate (TEHTH). These materials, when compared to DEHP-plasticized polyvinyl chloride materials, have greater gas permeability ~hat is beneficial for platelet storage.
The system 10 includes a means ~or connecting the initially separate subassemblies 12 and 1~ together for use. The connection means is associated with each of the initially separate a~semblies 12 and 14. The connection means permits selective attachment of the transfer assembly 14 to the blood collection assembly 12 (as shown in Fig.
2).
In the embodiment shown in Fig. 1, the connection means comprises two mating ~terile connection devices (deslgnated 66a and 66b). The devices 66a and 66b (see also Fig. 7) are described in Granzow et al U.S. Patents 4,157,723 and ~,265,280, which are incorporated herein by re~erence. One device 66a i~ carried by the outlet branch 26 of the assembly 12. The other device 66b is carried at the tubing end 56A of the transfer assembly 14.
As shown in Fig. 7, the sterile connection devices 66a and 66b each generally includes a housing 70 having a normally closed, meltable wall 72 made o~ a radiant energy absorbing material. The housings 70 are joined together with mating bayonet-type couplers 74a and 74b/ with the walls 72 placed in facing contact. When connected and exposed to radiant energy, the walls 72 melt at temperatures SU8S~ITUTE S~ET
,.. .. .. . , , ... ... ,., , : : . .
. .. . .. .. . . . ~ , . . .
.. . ~ . . . . . . . .
.... . . . . : .. ~ ~ .:
. . . . . .
.. . . . . ... .
. . . . . . .
. . ~. . . ~
.... ~
.
W092/2U4~7 PCr/US~2/03~7 that result in the destruction of bacteria, while at the same time opening a f:luid path between the connected housings 70~
The devices 66a and 66b normally close the associated assembli~s 12 and. ~4 from communication with the atmosphere and are opened in conjunction with an active sterilizatioll step which serves ~o sterilize the regions adjacent to the interconnecting fluid path as the ~luid path is being formPd. These devices 66a and 66b also hermetically seal the interconnecting fluid path at the time it is formed. The use of these sterile connection devices 66a and 66b assures a probability of non-sterility that exceeds one in a million. The devices 66a and 66b thus serve to connect the two assemblies 12 and 14 without compromising the sterile integrity of either.
Alternately, the connection means can comprise the sterile connecting system disclosed in Spencer U.SO Patent 4,412,835 (not shown). In this arrangement, this system forms a molten seal between the tuhing end 26 and 56A. Once cooled, a sterile weld is formed.
The assemblies 12 and 14, once sterilized, each consti~utes a sterile, "closed" system, as jl~dged by the applicable standards in the Vnitad States.
In use, whole blood is collected (via the donor tube 22) in the primary bag 16. The collected whol~ blood is then separated within the primary bag 16, preferably by centrifuging, into red blood cells (RBC) and platelet~rich plasma (PRP). An intermediate white ~lo~d cell layer (BC~ also forms.
Th~ assembly 12 i5 next joined to the assembly 14 (as Fig. 2 shows). The flow control $~;TIT~ ~EET
, . . .
~ . . , . :
:: , .: ~ , ...
W092/20427 PCT/US92/03~76 means is placed into its fi~.st processing mode by closing clamps 47; 48; 50; ~nd 54 (if previously opened) and by openi.ng clam]ps 46; 49; and 52 (if previously closed).
The platelet-rich plasma ~PRP) is conveyed from the primary bag 16 through second and third transfer paths 38 and 40 by con~entional techniques (for example by using a plasma expresser) into the transfer bag 32. In this step, attempts are made to leave all the red blood cells and as many white blood cells as possible in the primary bag 16. The handling of the platelet-rich components in this way avoids use of the separation device 36.
The clamp 52 is closed, and the transfer bags 30 and 32 are detached in a sterile fashion (as Fig. 3 shows). The detachment can be accomplished using a conventional heat sealing device (~or example, the Hematron~ dielectric sealer sold by Baxter Healthcare Corporation~, which forms a hermetic, snap-apart seal in the tubing 60 ~this seal is schematically shown by an "x" in Fig. 3 ~.
The donor tubing 22 is preferably sealed and disconnected in the same fashion (as shown in Fig.
2) before joining the two assemblies 12 and 14 together.
As Fig. 3 also shows, the platelet rich pla~ma can undergo subsequent centrifug~l separation within the transfer bag 32 into platelet concentrate (designated PC in Fig. 3) and platelet-poor plasma 3C (desi~nated PPP in Fig~ 3~. By opening clamp 54, the platelet-poor plasma (PPP) is transferred in~o the bag 30 ~or storage, leaYing the platelet concentrat~e in the bag 32. The transfer bags 30 and 32 are then separated by the snap-apart seals "x" in the ~ubing 32 (as shown in Fig. 3) ~or subsequent ~IU~5Tl~lJTE S'~
,. , ., ~ , . . .
: .
.
. .. . . .
.
WO9~/20427 pcr/lJs92/o34~L6 '~ ~J ~
storage as individual components.
The flow control mealls is next placed into its second processing mode to transfer the red blood cells ~with associated white blood cells) to the transfer container 28 via the separation device 36.
In the illustrat~d embodiment, th~
satellite container 18 holdr= a suitablP storage solution 5 for red blood cel].s. One such solution is disclosed in Grode et al U~S. Patent 4~267,269.
In this arrangement, prior to assuming the second processing mode, the flow control means is ~irst placed into a processing mode for directing the additive solution S from the satellite bag ~8 to the primary bay in a path that bypasses the separation device 36. This mode is ascomplished by closing clamp 48 and opening clamps 46 and 47. The solution A is transferred to th~ primary bag 16 via path ~0.
The second processin~ mode then proceeds by : closing clamps 47 and 49 and opening olamp 48. As shown in Fig. 3, the primary bag 16 is li~ted above the transfer bag 28, and the red blood cells (with associated white blood cells and additive solution S) are conveyed by gravity flow ~rom the bag 16 through the fluid path 34 and separation device 36 into the transfer bag 28. The undesired matter (i.e., white blood cells and platelets) are removed ~rom thQ red blood cells by the separ~tion device 36.
~hile th~ two assemblies 12 and 14 are still attached together, the flow control means is placed in i.t5 third mode, as Fig~ 4 shows. This is accomplishe.d by closing clamp ~8 and opening clamp 49, The transfer b~g 28 is li~ted above assembly 12. The re.d blood cells and additive solution, now substantially ~ree of the undesired white blood . ~ .
W~92/204~7 PCT/U~')2/03~7 ~ i ~ 3 . i cells, are. returned by gravity flow from the transfer bag 28 through the fluid path 38, bypassing the separation device ~6.
The filtered red blood cells can be returned for storage either to the pri~ary bag 16 (by opening clamp 46 and closing clamp 47~ or to the now empty satellite bag 18 (by closing clamp 46 and opening clamp 47). In the illustrated and preferred embodiment, the filtered r~d blood cells are conveyed to the satellite bag 18 for storage.
Should air be trapped in ~he transfer bag 28, it may be necessary to first transfer the air through bypass path 38 into the bag 16 or 18 in which the red blood cells will not be ultimately returned for storage.
As Fig. 5 shows, the satellite bag : containing the filtered red blood cells and additive solution is detached ~rom the blood collection assembly 12 for storage.
In one alternatiYe arrangement (not shown~, the assembly 12 could be made without an associated satellite bag 18. In this arrangement, the red blood cells are returned to the primary bag 16 for storage after filtration.
In another alternative arrangement tal60 not shown), the assembly 12 could include an associat d empty satellite bag9 without an additive solution. In this arrangement, the red blood cells are return~d to the satellite bag aPter filtration ~or ~torage :Eree o~ an additive ~olution.
Yet another alternative arrangement is shown in Fiy. 6. In this embodiment, like the embodiment shown in Fig. 1, the assembly 12 inoludes a primary bag 16 and a satellite bag 18. Also like the embodi.ment shown in Fig. 1, the a~sembly 14 .
,. , . . -.
, , ' ' :
W092/20427 P~T/lJ~2/03~7..6 includes a transfer container 28 with two associated flow paths 34 and 38, one 34 which includes ~he separation device 36, one 38 which does not.
Unlike the Fig. 1 embodiment, the transfer bags 30 and 32 are not associated with the assembly 14, but instead form an integral part of the assembly 12.
In using the embodiment shown in Fig. 6, whole blood i5 collected in the donor bag 16, where it is separated into red blood cells, platelet-rich plasma, and white blood cells in the manner already described in the Fig. 1 embodiment. In its first processing mode, the platelet-rich plasma is conveyed to the transfer bag 32 for processing.
Like the Fig. 1 embodiment, th~ path between the primary bag 16 and the transfer bags 30 and 32 bypasses the separation dPvice 36O
The transfer bag~ 30 and 32 are then detached from th assembly 12 in the manner previously described with respect to assembly 14.
The assembly 12 is then attached to the assembly 14, and the processing through $he remaining modes proceeds as previously described.
In the illustrated embodiments, the entire filtration proce~s (including the attachme~t and detachment of the assemblies 12 and 14) can be accomplished in less than five minutes. All blood components processed are subqtantially ~ree o~ the undesired matter~ In the preferred embodiment, where the all the fluid trans~ers are made using ~terile connection techniques, the processing and inline filt3-ation have occurred without compromising the.sterile integrity of any collected compon~nt or reducing their storage life.
: 35 Various modifications of the invention will SW~TIT~ S~~
.
. : . . : . .
. . . --_, -. . .
.
.~ .
~ 92/20427 PCI/US92/03~76 be apparent to those skilled in the art within the purview of the following claims.
' ' ~
.
SUBSlTrU~ SH~E~
'';' ' ~ i ` - : :
, . . `., .
.~ .- , . . .
Claims (32)
1. A method of collecting blood components comprising the steps of collecting blood having the undesired matter in a blood collection assembly, separating the blood in the blood collection assembly into a first component and a second component that contains undesired matter, opening communication between the blood collection assembly and first and second transfer assemblies, the first transfer assembly having a first transfer container, a first transfer path that leads to the first transfer container and that includes means for separating the undesired matter from the blood, a second transfer path that leads to the first transfer container and that bypasses the separation means, and the second transfer assembly having a second transfer container and a third transfer path that communicates with the second transfer path and that leads to the second transfer container bypassing the separation means, conveying the first component to the second transfer container through the second and third transfer paths, thereby bypassing the separation means, conveying the second component to the first transfer container through the first transfer path, thereby passing the second component through the separation means to remove the undesired matter, and transferring the second component, now substantially free of the undesired matter, from the first transfer container back through the second transfer path to the blood collection assembly for storage.
2. A method according to claim 1 wherein the step of opening communication between the blood collection assembly and the first and second transfer assemblies includes joining the first and second transfer assemblies to the blood collection assembly.
3. A method according to claim 1 and further including the step, which occurs after the step of conveying the first component to the second transfer container, of separating the second transfer assembly from the blood collection assembly.
4. A method according to claim 1 and further including the step, which occurs after the step of conveying the second component back to the blood collection assembly, of separating the first transfer assembly from the blood collection assembly.
5. A method according to claim 1 or 3 and further including the step, which occurs after the step of conveying the first component to the second transfer container, of separating the first component into additional component parts within the second transfer assembly.
6. A method of collecting blood components comprising the steps of collecting blood having the undesired matter in a blood collection assembly that has a collection container, in which the blood is collected, and a satellite container, separating the blood in the collection container into a first component and a second component that contains undesired matter, opening communication between the first container of the blood collection assembly and first and second transfer assemblies, the first transfer assembly having a first transfer container, a first transfer path that leads to the first transfer container and includes means for separating the undesired matter from the blood, and a second transfer path that leads to the first transfer container and that bypasses the separation means, and the second transfer assembly having a second transfer container and a third transfer path that communicates with the second transfer path and that leads to the second transfer container bypassing the separation means, conveying the first component from the collection container to the second transfer container through the second and third transfer paths, thereby bypassing the separation means, conveying the second component from the collection container to the first transfer container through the first transfer path, thereby passing the second component through the separation means to remove the undesired matter, and opening communication between the satellite container and the second transfer path to transfer the second component, now substantially free of the undesired matter, from the first transfer container through the second transfer path into the satellite container for storage.
7. A method according to claim 6 wherein the satellite container holds an additive solution for the second component, and further including the step, which occurs prior to the step of conveying the second component to the first transfer container through the separation means, of transferring the additive solution to the first container.
8. A method according to claim 7 wherein the step of opening communication between the first container and the first and second transfer assemblies includes joining the first and second transfer assemblies to the blood collection assembly.
9. A method according to claim 7 and further including the step, which occurs after the step of conveying the first component to the second transfer container, of separating the second transfer assembly from the blood collection assembly.
10. A method according to claim 7 and further including the step, occurring after the step of conveying the second component to the satellite container, of separating the satellite container from the blood collection assembly.
11. A method according to claim 7 or 8 and further including the step, occurring after the step of conveying the first component to the second transfer container, of separating the first component into additional component parts within the second transfer assembly.
12. A method of collecting blood components comprising the steps of collecting blood having the undesired matter in a blood collection assembly that has a collection container, in which the blood is collected, and a satellite container, separating the blood in the collection container into a first component and a second component that contains the undesired matter, opening communication between the blood collection assembly and first and second transfer assemblies, the first transfer assembly having a first transfer container, a first transfer path that leads to the first transfer container and includes means for separating the undesired matter from the blood, and a second transfer path that leads to the first transfer container bypassing the separation means, and the second transfer assembly having a second transfer container and a third transfer path that leads to the second transfer container and that bypasses the separation means, conveying the first component from the collection container to the second transfer container through the third transfer path, thereby bypassing the separation means, conveying the second component from the collection container to the first transfer container through the first transfer path, thereby passing the second component through the separation means to remove the undesired matter, and transferring the second component, now substantially free of the undesired matter, from the first transfer container back through the second transfer path to the satellite container of blood collection assembly for storage.
13. A method according to claim 12 wherein the satellite container holds an additive solution for the second component, and further including the step, which occurs prior to the step of conveying the second component to the first transfer container through the separation means, of transferring the additive solution from the satellite container to the collection container.
14. A method according to claim 12 wherein the step of opening communication between the blood collection assembly and the first and second transfer assemblies includes joining the first and second transfer assemblies to the blood collection assembly.
15. A method according to claim 12 and further including the step, which occurs after the step of conveying the first component to the second transfer container, of separating the second transfer assembly from the blood collection assembly.
16. A method according to claim 12 and further including the step, which occurs after the step of conveying the second component to the satellite container, of separating the satellite container from the blood collection assembly.
17. A method according to claim 12 or 14 and further including the step, which occurs after the step of conveying the first component to the second transfer container, of separating the first component into additional component parts within the second transfer assembly.
18. A method of collecting blood components comprising the steps of:
collecting in a first container a first blood component that comprises plasma and platelets and a second, red blood cell-containing component that includes white blood cells, opening communication between the first container and a transfer assembly to convey the first blood component from the first container into a transfer assembly, separating the transfer assembly containing the first blood component from the first container, opening communication between the first container and a satellite container that contains an additive solution to convey the additive solution into the first container, opening communication between the first container and another transfer assembly through a fluid path that includes means for separating white blood cells from blood to convey the second, red blood cell-containing component, now with additive solution, to the other transfer assembly while at the same time separating the white blood cells from the red blood cells, opening communication between the other transfer assembly and the satellite container through a fluid path that bypasses the separation means the convey the red blood cells, now with additive solution but substantially free of white blood cells, from the other transfer assembly into the satellite container through the fluid path that bypasses the separation means, and separating the satellite container containing the red blood cells substantially free of white blood cells for storage.
collecting in a first container a first blood component that comprises plasma and platelets and a second, red blood cell-containing component that includes white blood cells, opening communication between the first container and a transfer assembly to convey the first blood component from the first container into a transfer assembly, separating the transfer assembly containing the first blood component from the first container, opening communication between the first container and a satellite container that contains an additive solution to convey the additive solution into the first container, opening communication between the first container and another transfer assembly through a fluid path that includes means for separating white blood cells from blood to convey the second, red blood cell-containing component, now with additive solution, to the other transfer assembly while at the same time separating the white blood cells from the red blood cells, opening communication between the other transfer assembly and the satellite container through a fluid path that bypasses the separation means the convey the red blood cells, now with additive solution but substantially free of white blood cells, from the other transfer assembly into the satellite container through the fluid path that bypasses the separation means, and separating the satellite container containing the red blood cells substantially free of white blood cells for storage.
19. A method according to claim 18 and further including the step, which occurs after the step of separating the transfer assembly containing the first component, of separating the first component into a plasma component and a platelet component within the separated transfer assembly.
20. A blood collection system comprising a blood collection assembly including an outlet flow path, a transfer assembly including a first transfer container, a second tranfer container, a first transfer path that leads to the first transfer container and that includes means or separating the undesired matter from blood, a second transfer path that leads to the first transfer container and that bypasses the separation means, and a third transfer path that communicates with the second transfer path and that leads to the second transfer container bypassing the separation means, means for directing fluid flow between the outlet flow path and the first, second and third transfer paths including flow control means operable (i) in a first mode for directing a first quantity of blood from the blood collection assembly for collection in the second transfer container through the second and third transfer paths, the first quantity of collected blood thereby bypassing the separation means;
(ii) in a second mode for directing a second quantity of blood from the blood collection assembly to the first transfer container through the first transfer path, the second quantity of the blood thereby passing through the separation means to remove the undesired materials; and (iii) in a third mods for directing the second quantity of blood from the first transfer container back to the blood collection assembly through the second flow path for storage, thereby bypassing the separation means.
(ii) in a second mode for directing a second quantity of blood from the blood collection assembly to the first transfer container through the first transfer path, the second quantity of the blood thereby passing through the separation means to remove the undesired materials; and (iii) in a third mods for directing the second quantity of blood from the first transfer container back to the blood collection assembly through the second flow path for storage, thereby bypassing the separation means.
21. A blood collection system according to claim 20 wherein the blood collection assembly includes a primary container and a satellite container, wherein the outlet flow path includes a first branch that communicates with the primary container and a second branch that communicates with the satellite container, and wherein, when operated in its first and second modes, the flow control means directs the first and second quantities of blood from the primary container, and when operated in its third mode, the flow control means directs the second quantity of blood from the first transfer container to the satellite container and not the primary container.
22. A blood collection system according to claim 21 wherein the satellite container contains an additive solution, and wherein the flow control means is operative in a fourth mode for directing the additive solution from the satellite container to the primary container through the first and second branches, bypassing the separation means.
23. A blood collection system according to claim 20 wherein the blood collection assembly and the transfer assembly comprise separate subassemblies, and wherein the means for establishing communication includes means for attaching the blood collection subassembly to the transfer subassembly.
24. A blood collection system according to claim 20 wherein the blood collection subassembly includes a primary container and a satellite container, wherein the outlet flow path includes a first branch that communicates with the primary container and a second branch that communicates with the satellite container, and wherein, when operated in its first and second modes, the flow control means directs the first and second quantities of blood from the primary container, and when operated in its third mode, the flow control means directs the second quantity of blood from the first transfer container to the satellite container and not the primary container.
25. A blood collection system according to
24. A blood collection system according to claim 20 wherein the blood collection subassembly includes a primary container and a satellite container, wherein the outlet flow path includes a first branch that communicates with the primary container and a second branch that communicates with the satellite container, and wherein, when operated in its first and second modes, the flow control means directs the first and second quantities of blood from the primary container, and when operated in its third mode, the flow control means directs the second quantity of blood from the first transfer container to the satellite container and not the primary container.
25. A blood collection system according to
claim 24 wherein the satellite container contains an additive solution, and wherein the flow control means is operative in a fourth mode for directing the additive solution from the satellite container to the primary container through the first and second branches, bypassing the separation means.
25. A blood collection system according to claim 20 wherein the blood collection assembly and the transfer assembly each comprise a separate closed subassembly, and wherein the means for establishing communication includes connection means associated with the transfer subassembly and the blood collection subassembly for attaching and detaching the collection and transfer subassemblies in a manner that preserves the sterile integrity of the closed subassemblies.
WO 92/20427 PCT/US92/03476
27. A blood collection system comprising a blood collection assembly including a primary container having a first and second outlet branches, a satellite container that communicates with the first outlet branch of the primary container, a first transfer assembly including a transfer container, a first transfer path that leads to the first transfer container and that includes means for separating the undesired matter from blood, and a second transfer path that leads to the first transfer container and that bypasses the separation means, a second transfer assembly including a third transfer path that bypasses the separation means, means for establishing communication between the first outlet branch of the primary container and the first and second transfer paths, means for establishing communication between the second outlet branch of the primary container and the third transfer path, and flow control means operable (i) in a first mode for directing a first quantity of blood from the primary container for collection in the second transfer assembly through the third transfer path, the first quantify of collected blood thereby bypassing the separation means;
(ii) in a second mode for directing a second quantity of blood from the primary container to the first transfer container through the first transfer path, the second quantity of the blood thereby passing through the separation means to remove the undesired materials; and (iii) in a third mode for directing the second quantity of blood from the first transfer container back to the satellite container through the second flow path for storage, thereby bypassing the separation means.
(ii) in a second mode for directing a second quantity of blood from the primary container to the first transfer container through the first transfer path, the second quantity of the blood thereby passing through the separation means to remove the undesired materials; and (iii) in a third mode for directing the second quantity of blood from the first transfer container back to the satellite container through the second flow path for storage, thereby bypassing the separation means.
28. A blood collection system according to claim 27 wherein the satellite container contains an additive solution, and wherein the flow control means is operative in a fourth mode for directing the additive solution from the satellite container to the primary container through the second outlet branch, bypassing the separation means.
29. A blood collection system according to claim 27 wherein the blood collection assembly and the first transfer assembly comprise separate subassemblies, and wherein the means for establishing communication includes means for attaching the first outlet branch of the primary container to the first transfer subassembly.
30. A blood collection system according to claim 27 or 29 wherein the second transfer assembly is integrally connected to the second outlet branch of the primary container.
31. A blood collection system according to claim 27 wherein the blood collection assembly and at least the first transfer assembly each comprise a separate closed subassembly, and wherein the means for establishing communication includes connection means associated with the first transfer subassembly and the blood collection subassembly for attaching and detaching the collection and first transfer subassemblies in a manner that preserves the sterile integrity of the closed subassemblies.
32. An assembly usable in association with a primary blood collection system comprising a primary container, for removing undesired matter from blood cells, the separation assembly comprising a temporary transfer container and an interconnected transfer/storage container, a first fluid path communicating with the temporary transfer container and having an inline separation means for separating undesired matter from blood cells, a second fluid path individually communicating with each transfer container and bypassing the separation means, flow control means associated with the first and second flow paths operable in a first mode for directing fluid through the second flow path into the transfer/storage container, bypassing the separation means; in a second mode for directing fluid through the first flow path into the temporary transfer container through the separation means to remove undesired matter therefrom; and in a third mode for directing fluid Prom the temporary transfer container through the second flow path bypassing the separation means, and means for establishing communication between the separation assembly and the collection assembly.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US7/704,029 | 1991-05-22 | ||
| US07/704,029 US5128048A (en) | 1991-05-22 | 1991-05-22 | Systems and methods for removing undesired matter from blood cells |
| PCT/US1992/003476 WO1992020427A1 (en) | 1991-05-22 | 1992-04-27 | Systems and methods for removing undesired matter from blood cells |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2086514A1 true CA2086514A1 (en) | 1992-11-23 |
Family
ID=24827773
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002086514A Abandoned CA2086514A1 (en) | 1991-05-22 | 1992-04-27 | Systems and methods for removing undesired matter from blood cells |
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| Country | Link |
|---|---|
| US (1) | US5128048A (en) |
| EP (2) | EP0714667B1 (en) |
| JP (1) | JPH06500254A (en) |
| AU (1) | AU647958B2 (en) |
| CA (1) | CA2086514A1 (en) |
| DE (2) | DE69231569T2 (en) |
| WO (1) | WO1992020427A1 (en) |
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-
1991
- 1991-05-22 US US07/704,029 patent/US5128048A/en not_active Expired - Fee Related
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1992
- 1992-04-27 AU AU21996/92A patent/AU647958B2/en not_active Ceased
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- 1992-04-27 JP JP5500055A patent/JPH06500254A/en active Pending
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- 1992-04-27 CA CA002086514A patent/CA2086514A1/en not_active Abandoned
- 1992-04-27 EP EP92913358A patent/EP0540731B1/en not_active Expired - Lifetime
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| AU2199692A (en) | 1992-12-30 |
| AU647958B2 (en) | 1994-03-31 |
| US5128048A (en) | 1992-07-07 |
| DE69231569T2 (en) | 2001-06-21 |
| EP0540731B1 (en) | 1997-01-15 |
| EP0714667B1 (en) | 2000-11-15 |
| EP0540731A1 (en) | 1993-05-12 |
| EP0540731A4 (en) | 1994-12-07 |
| WO1992020427A1 (en) | 1992-11-26 |
| DE69216767T2 (en) | 1997-09-04 |
| JPH06500254A (en) | 1994-01-13 |
| DE69216767D1 (en) | 1997-02-27 |
| DE69231569D1 (en) | 2000-12-21 |
| EP0714667A2 (en) | 1996-06-05 |
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