CA2086517C - Systems and methods for removing undesired matter from blood cells - Google Patents
Systems and methods for removing undesired matter from blood cells Download PDFInfo
- Publication number
- CA2086517C CA2086517C CA002086517A CA2086517A CA2086517C CA 2086517 C CA2086517 C CA 2086517C CA 002086517 A CA002086517 A CA 002086517A CA 2086517 A CA2086517 A CA 2086517A CA 2086517 C CA2086517 C CA 2086517C
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- transfer
- transfer container
- container
- blood
- blood collection
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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
- A61M1/0231—Multiple bag systems for separating or storing blood components with gas separating means, e.g. air outlet through microporous membrane or gas bag
-
- 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3643—Priming, rinsing before or after use
- A61M1/3644—Mode of operation
-
- 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
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3643—Priming, rinsing before or after use
-
- 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
Systems and methods of collecting blood cells use a first container (16) connected to at least three transfer containers (18, 26, 34). A filtration system (10) is provided with one transfer container (34), which ultimately serves as the storage container for red blood cells free of white blood cells. The two other transfer containers (18, 26) are connected to each other, one (18) of which is empty and one (26) or which contains an additive solution (S) for storage of red blood cells.
The empty transfer container (18) is used for storage of platelet concentrate, while the container (26) that originally contained the additive solution is ultimately used to store the platelet-poor plasma component. A
portion of the additive solution (5) may be separately passed through the filtration system (10) after filtration of the red cells to flush additional red blood cells from the filtration device (40).
The empty transfer container (18) is used for storage of platelet concentrate, while the container (26) that originally contained the additive solution is ultimately used to store the platelet-poor plasma component. A
portion of the additive solution (5) may be separately passed through the filtration system (10) after filtration of the red cells to flush additional red blood cells from the filtration device (40).
Description
a.~
4V~ 92/20~12~ ~'~ 1I'/ll~:'~.c.~ ~~.,~ ~ ~~~: i i SYSTEMS 1~.ND METH~3D8 F'~R RE.hi~ty~i~IG UIJDES~RED ' MR'~L"fER FRt~Nt BL~OD CELLS
Field of the Iriveritiori:
The invention generally relates to blood collection and pracessing systems and methods. In a more particular sense, the invention relates to sys tams and methods for removing white blood cells from red bland cells prior to transfusion or long term storage.
Haakarouric3 ~f the Triveritxoric Most of the whole blood collected from do-nors today is not itself stored and used for transfusion. Instead, the whole blood is separated into its clinically proven companents (typically red blood cells, platelets, and plasma), which are them-selves individually stored and used to treat a multi-plicity of specific conditions and diseased states.
Far example, the red blood cell component is used to treat anemia; the concentrated platelet component is ~0 used to control thrombocytopenic bleedings and the platelet-poor plasma component is used as a volume expander ox as a source of Clotting Factor VIII for the treatment of hemophilia.
systems composed of multiple, interconnected plastic bags have met widespread case and acceptance in ~(l3~ ~1~~
i~~ 92/2042 P~:'1'/1J~9~/~l~~s %'l the collection, processing and storage of these blood components. In the United States, these multiple blood bag systems are subject to regulation by the government. For example, the plastic materials from which the bags and tubing are made must be approved by the government. In addition, the maximum storage pe-riods for the blood components collected in these sys-tems are prescribed by regulation.
In the United States, whole blood components to collected in a nonsterile, or "open", system (i.e. one that is open to communication with the atmosphere) must, under governmental regulations, be transfused within twenty-four hours. However, when whole blood components are collected in a sterile, or ''closed", system (i.e., one that is closed to communication with the atmosphere), the red blood cells can be stored up to forty-two days (depending upon the type of antico-agulant and storage medium used) ; the platelet concen-trate can be stored up to five days (depending upon the type of storage container); and the platelet--poor plasma may be frozen and stored for even longer peri-ods. Conventional systems of multiple, interconnected plastic bags have met with widespread acceptance, be-cause these systems can reliably provide the desired sterile, "closed°' environment for blood collection and processing, thereby assuring the maximum available st~rage periods.
In collecting whole blood components for transfusion, ft is desirable to minimize the presence of Rmpuxities or other materials that may cause unde-sired side effects in the recipient. For example, ba~cause of p~assible febrile reactions, it is generally ' c~rasidered desirable to transfuse red blaod cells sub' stanta.ally free of the white blood cell co~aponents, particularly for recipients who undergo ~rec~uent WO 92/20~t2~t 'PC"'l'IUJ~'l~,c~;..,! i l -transfusions.
One way to remove ~;ahite blood cells is by washing the red blood cells with saline. This tech-nique is time consuming and inefficient, as it can reduce the number of red blood cells available for transfusion. The washing process also exposes the red blood cells to communication with the atmosphere, and thereby constitutes a "non-sterile" entry into the storage system. Once a non-sterile entry is made in a previously closed system, the system is considered °'opened°', and transfusion must occur within twenty-four hours, regardless of the manner in which the blood was collected and processed in the first place.
In the tTnated States, an entry into a blood collection Z5 system that presents the probability of non-sterility that exceeds one in a million is generally considered to constitute a "non-sterile" entry.
Another way to remove white blood cells is by filtration. Systems and methods far accomplishing this within the context of conventional multiple blood bag configurations are described in Wisdom tl.S. Pat-ents 4,596,657 and 4,767,541, as well as in Carmen et al TJ.S. Patents 4810,378 and 4,855,063. In these arrangements, an inline white blood cell filtration device is used. The filtration can thereby be accom~
plashed in a closed system. However, the filtration processes associated with these arrangements rec;uire the extra step og wetting the filtration device before use with a red blood cell additive solution or the li3ce. This added step complicates the filtration pro-cess and inc;re~ses the processing time.
Other systems and methods for removing white blood cells in the context of closed, multiple blood bag configurations are described in Stewart U.S. Pat ent 4,997,577. In 'these filtration systems and meth-__ ego 9zrzo4zs ~~-rr~~~~a.; ~, J, ; ;
_ ods, a transfer assembly dedicated solely to the re-moval of white blood cells is used. The transfer as-sembly is attached to a primary blood collection con-tainer. The transfer assembly has a transfer contain-s er and a first fluid path leading to the transfer con-tainer that includes an inline device for separating white blood cells from red blood cells. The transfer assembly also has a second fluid path that bypasses the separation device. Tlsing these systems and meth-ods, white blood cells are removed as the red blood cells are conveyed to the transfer container through the first fluid path. The red blood cells, now sub-stantially free of white blood cells, are then con-veyed from the transfer container back to the primary collection container for storage through the second fluid path, this time bypassing the separation deviceo A need still exists for further improved systems and methods for removing undesired matter from blood components prior to transfusion or storage in a way that lends itself to use in closed multiple blood bag system environments.
W a~nma~~ of the ~tr~ve~t~.~n:
The invention provides a multiple container blood collection system for conveniently processing the various components of blood. The system includes a device for separating the undesired matter during processing. The system is arranged so that some com~
ponents can be conveyed through the separation device, while other components can be readily conveyed along other paths that bypass the separation device. The system is a:Lso arranged so that only a single pass through the separation device is required during a given processing sequence.
The invention provides a blood collection system that includes a blood collection assembly, a ;~ ~ ~D .~. ~,~
W~ 9~/20~2~ P"Clf'/lU'~'~~oti.3'; /'l first transfer assembly, and <3 second transfer assem-bly. The First transfer assembly has an empty first transfer container and a second transfer cowtainer that contains an additive salution. The second trans-fer assembly has a third transfer container and a flu id path that leads to the third transfer container and that includes means for separating undesired matter from blood. The system also has flow control means operable in various processing modes for directing fluid flow within the system.
In one arrangement, the flow control means includes four processing modes. In a first mode, the flow control mans directs a first quantity of blood from the blood collection assembly for collection in the first transfer container. In a second mode, the flow control means directs additive solution.from the second transfer container into the blood collection assembly to mix with the quantity of blood remaining in the blood collection assembly. In a third mode, 2o the flow control means directs the mixture of the ad-ditive solution and the remaining blood from the blood collection assembly to the third transfer container through the separation means to remove the undesired materials. In a fourth mode, the flow control means directs a constituent of the blond contained in the first transfer container into the second transfer con-tainer for collection. °
In another arrangement, the flow control means includes five processing modes. In a first 3~ mode, the flow control means directs a first quantity of blood from the blood collection assembly for col lection in the first transfer container. In a second mode, the flow control means directs a first quantity, but not all, of the additive solution from the second transfer container into the blood collection assembly w~ 92i~onzs ~ ~ ~ ~ ..~ ~. ~ ~crius~~'~:~s,.~ _ to mix with the quantity of blood remaining in the blood collection assembly. Tn a third mode, the flow control means directs 'the mixture of the additive so-lution a.nd the remaining blood from the blood collec- .
tion assembly to the third transfer container through the separation means to remove: the undesired materi-als. In a fourth mode; the flow control means directs the remaining quantity of the additive solution from the second transfer container into the 'third transfer container through the separation means, thereby using the remaining additive solution to flush the separa-tion means as it is being conveyed to the third trans-fer container. In a fifth mode, the flow control means directs a constituent of the blood contained in the first transfer container into the second transfer container for collection.
In either embodiment, the second transfer assembly -can include means for venting air from the third transfer container in a path that bypasses the separation means.
Also in either embodi~aent, at least one of the blood collection assembly, the first transfer as-sembly, and the second transfer assembly can comprise an initially separate subassembly, In this arrange-merit, the system further includes means for attaching the separate subassembly to the other parts of the system at tixae of use .
The invention also provides methods of col lecting blood components substantially free of unde sired matter using the systems as just generally de scribed.
The invention provides blood processing sys-tems and methods in which separation is accomplished using a minimum number ~f bags or other containers.
Since the container that serves as the blood additive container prior to separation also serves as a storage container for one of the blood components after separation, economies are realized.
The systems and methods that embody the features of the invention are particularly well suited for use in association with closed blood collection systems and conventional sterile connection techniques, thereby permitting separation to occur in a sterile, closed environment.
While the systems and methods that embody the features of the invention can be used to process all types of blood components, they are well suited for the removal of white blood cells from red blood cells by filtration prior to transfusion or .Long term storage.
According to one aspect of the invention, there is provided a method of collecting blood components comprising the steps of:
collecting blood having the undesired matter in a blood collection container, separating blood in the blood collection container into a first component a.nd a second component that contains the undesired matter, opening communication between the blood collection container and a first transfer assembly having an empty first transfer container and a second transfer container that contains an additive solution intended for the second component, to (i) convey the first component essentially free of the undesired matter from the blood collection container into the Empty first transfer container and (ii) convey the additive solution from the second transfer container into -the blood collection container to mix the additive solution with the second -7a-component that contains the undesired matter, opening communication between the blood collection container and a second transfer assembly having a third transfer container and a fluid path that leads to the third transfer conta_Lner and that includes means for separating the undesired matter from the blood, to convey the mixture of the additive solution and the second component that includes the undesired matter into the third transfer container through the separation means to remove the undesired matter, separating the first component within the first transfer container into first and second constituent parts, and transferring the first constituent part into the second transfer container for storage, bypassing the blood collection container, while retaining the second constituent part in the first transfer container for storage.
According to another aspect of the invention, there is provided a method of collecting blood components comprising the steps of:
collecting blood having the undesired matter in a blood collection container, separating the blood in the blood collection container into a first component and a second component that contains the undesired matter, opening communication between the blood collection container and a first transfer assembly having an empty first transfer container and a second transfer container that contains an additive solution, to (i) convey the first component from the blood collection container into the empty first transfer container and (ii) convey a first quantity the additive solution from -7b-the second transfer container into the blood collection container to mix the additive solution with the second component that contains the undesired matter, opening communication between the blood collection container and a second transfer assembly having a third transfer container and a fluid path that leads to the third transfer container and that includes means for separating the undesired matter from the blood, to convey the mixture of the firsts quantity of additive solution and the second component that includes the undesired matter into the third transfer container through the separation means to remove the undesired matter, and opening communication between the first and second transfer assemblies to convey a second quantity of the additive solution from the second transfer container through the separation means, bypassing the blood collection container into the mixture contained in the third transfer container and thereby flush additional second component from the separation means.
According to a further aspect of the invention, there is provided a blood collection system comprising:
a blood collection assemb~_y, a first transfer assembly comprising an empty first transfer container and a second transfer container that contains an additive solution, a second transfer assembly comprising a third transfer container and a fluid path that leads to the third transfer container and that. includes means for separating undesired matter from blood, and means for directing fluid flow within the system including flow control means operable (i) in a first mode for directing a first -7c-quantity of blood from the blood collection assembly for collection in the first transfer container, (ii) in a second mode for directing additive solution from the second transfer container into the blood collection assembly to mix with the quantity of blood remaining in the blood collection assembly, (iii) in a third mode for' directing the mixture of the additive solution and the remaining blood from the blood collection assembly to the third transfer container through the separation means to remove the undesired materials, and (iv) in a fourth mode for directing a constituent of the blood contained in the first transfer container into the second transfer container bypassing the blood collection assembly for collection.
According to another aspect of the invention, there is provided a blood collection system comprising:
a blood collection assemb_Ly, a first transfer assembly comprising an empty first transfer container and a second transfer container that contains an additive solution, a second transfer assembly comprising a third transfer container and a fluid path that leads to the third transfer container and than includes means for separating undesired matter from blc>od, and means for directing flvuid flow within the system 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 first transfer container, (ii) in a second mode f'or directing a first quantity of the additive solution from the second transfer container into the blood collection assembly to o R
-7d-mix with the quantity of blood remaining in the blood collection assembly, (iii) in a third mode fox° directing the mixture of the additive solution and the remaining blood from the blood collection assembly to the third transfer container through the separation means to remove the undesired materials, (iv) in a fourth mode for directing a second quantity of the additive solution from the second transfer container into the third transfer container through the separation means, bypassing the blood collection assembly, and (iv) in a fifth mode for directing a constituent of the blood contained in the first transfer container into the second transfer container for collection.
According to a further aspect of the invention, there is provided an assembly usab:Le in association with a primary blood collection system, the assembly comprising:
a first transfer container made of a material that, when compared to DEHP-plasticized polyvinyl chloride materials, has a greater gas permeability that is beneficial for platelet storage, a second transfer container that holds an additive solution for red blood cel7.s, conduit means having one branch that communicates with the first transfer container, a second branch that communicates with the second transfer container, and a third branch that: joins the first and second branches and includes means for connecting the conduit means and associated containers to a primary blood collection system, and -7e-means operative, when the conduit means is attached to the primary blood collection system, for directing fluid flow between the conduit means and the blood collection system and including flow control means operative (i) in a first mode for directing a platelet-rich blood component from the primary collection system into the first transfer container;
(ii) in a second mode for directing the additive solution from the second transfer container to the primary blood collection system; and (iii) in a third mode for' directing a platelet-poor constituent separated from the component contained in the first transfer container unto the second transfer container, leaving a concentration of platelets in the first transfer container for storage.
Other features and advantages of the invention will become apparent upon review of the following description, drawings, and appended claims.
Brief Description of the Drawings Fig. 1 is a schematic view of a blood collection system of the present invention;
Fig. 2 is a schematic view of the system shown in Fig. 1 being used to transfer platelet-rich component to an associated transfer assembly;
Fig. 3 is a schematic view of the system shown in Fig. 1 being used to transfer an additive solution from the associated transfer assembly into the red blood cells in the primary collection container;
Fig. 4 is a schematic view of the system shown in Fig. 1 being used to remove undesired matter from the red blood cells in another transfer assembly, while -7f-platelet and plasma separation occurs in the now separated first transfer assembly;
Fig. 5 is a schematic view of the system shown i n F' i rr 1 c..~ ; t- h ~ l l +-1-, o ~ o o r, .~, ; ~ +- .~ ~ r. +- ., ". -. ,-... .. ,-.,..
p pp ~1~~~'; i"~ ._ ~~~~~J~~r~.:r~~~~
tamers separated for the storage of individual compa-nents;
Fig. 6 is a schematic: view of an alternative arrangement of the system shown in Fig. 1, in which the various assemblies comprise initially separate subassemblies that are joined to gather at time of use;
Fag . 7 is an enlarged side sectional view of the sterile connection devices associated with the l0 systems shown in Fig. 6;
Fig. 8 is a schematic view of the system shown in Fig. 1 being used with an alternative step of flushing the separation device with a portion of the additive solution after filtration is completed; and Fig. 9 is broken away sectional view of a filtration device usable in association with.the sys-tem shown in Fig. 1 and having an air bleed channel far venting air from the transfer container.
I3e~o~itatiou of the Pref~~~ed oditnexat~s:
A blood collection assembly 10 is shown in Fig. 1, The assembly l0 comprises a closed blood col-lection system. In the illustrated embodiment, the assembly 10 serves to separate and store the red blood cells as well as the plasma and platelet blood compo-vents by conventional centrifugation technidues, while removing undesired matter from the red blood sells prior to storage. In the illustrated embodiment, the undesired matter is removed by filtration.
As used herein, the term °°filtration°° is in tended t~ include separation achieved by various cen trifugal and non-centrifugal techraic~ues, and not merely "filt:ration'° in the technical sense. Separa tion can occur by absorption, columns, chemical, elec trical, and electromagnetic means. The term °°f:iltra 39 Lion°° is thus broadly used in this specification to 2~~~~~'~
rw~ 9zizo~szs ~crvus9zio~~~~
_ g _ encompass all of these Separation techaiiques as well.
In the illustrated a,nd preferred embodiment shown in Fig. 1, the assembly l0 includes a primary bag or container 16 and various transfer bags or con s tainers 18, 26, and 34 that eras attached to the prima ry bag 16 by integrally attached branched tubing 28.
The tubing 28 is divided by appropriate connectors into branches 29, 30, and 32.
In the illustrated embodiment, flow c~ntrol devices 31, 33, and 35 are provide on the branched fluid flow paths as shown to enable directing of the ' fluid transfers in a desired sequence of steps. In the illustrated arrangement, the flow control devices take the form of conventional roller clamps that are manually operated to open and close the associated tubing paths.
In use, the primary bag 16 (which is also called a donor bag) receives whole blood from a donor through integrally attached donor tubing 22 that car-ries an phlebotomy needle 24. A suitable anticoagu-lant A is contained in the primary bag 16.
The transfer bag 26 contains a suitable storage solution S for the red blood cells. One such s~luti~on is disclosed in Grade et al iJ.s. patent 4,267,269.
The transfer bag 18 is intended to receive the platelet and plasma blood components associated with the whole blood collected in the primary bag 16. .
According to the invention, the transfer bag 1.8 ulti--mately serves as the storage container for the plate let concentrate constituent. Also according to the invention, the transfer bag 26 else ultimately serves as the storage container for the platelet-poor plasma constituent.
Flow control device 33 is located in tubing ~~ ~2izoazg ~ ~ ~'~ .~ ~ ~ ~c~riu~azeo:~~°rr °-30 to control fluid flow to and from the transfer bag 18. Flow control device 35 is lacated in tubing 32 to control fluid flow to and from transfer bag 26.
Tubing 28 and 29 fcarm a flow path to the 5 container 34. This flow path includes an inline fil tration device 40 for separating undesired matter from blood cells. Flow control means 31 is located on ~tub ing 29 which leads to a separation device 40. Accord ing to the invention, the container 34 ultimately l0 serves as a storage container fox the red blood cells after passage through the separation device 40.
The bags and tubing associated with the pro-cessing assembly 10 can be made from conventianal ap-proved medical grade plastic materials, such as poly-vinyl chloride plasticised with di-2-ethylhexyl-phthalate (DEHP). The ends of the tubing may be con-nected by a "Y°' or "T" connectors to form the branched fluid flow paths.
Alternatively, transfer container 18, which is intended to store the platelet concentrate, can be made of polyolefin material (as disclosed in ~ajewski et al U.S. Patent 4,140,162) or a polyvinyl chloride material plasticised with tri-2-ethylhexyl trimel-litate (TENTH). These materials, when compared to DEHP-plasticised polyvinyl chloride materials, have greater gas permeability that is beneficial for plate-let storage.
The blood collection and storage assembly 10, once sterilized, constitutes a sterile, "closed"
system, as judged by the applicable standards in the United States.
When the system 10 is used according to the invention,,whole blood is collected in the primary bag 16. The collected whole blood is centrifugally sepa-rated within the primary bag 16 into a red blood cell component (.designated RBC in Fig. 2) and platelet-rich plasma component (designated P:RP in Fig. 2). During such separation techniques, a.layer of white blood cells (commonly called the "buf:Ey coat" and designated BC in Fig. 2) forms between the red blood cells and the platelet-rich plasma.
In a first processing mode (shown in Fig.
2), the platelet-rich plasma component is transferred by conventional techniques from the primary bag 16 to l0 the transfer bag 18: This tran:~fer is accomplished by opening clamp 33, while closing clamps 31 and 35. In this step, attempts are made to keep as many white blood cells in the primary bag 16 as possible. The transfer of platelet-rich plasma into the first trans-fer bag 18 leaves the red blood cells and the remain-ing white blood cells behind in the primary bag 16.
In a second processing mode (shown in Fig.
4V~ 92/20~12~ ~'~ 1I'/ll~:'~.c.~ ~~.,~ ~ ~~~: i i SYSTEMS 1~.ND METH~3D8 F'~R RE.hi~ty~i~IG UIJDES~RED ' MR'~L"fER FRt~Nt BL~OD CELLS
Field of the Iriveritiori:
The invention generally relates to blood collection and pracessing systems and methods. In a more particular sense, the invention relates to sys tams and methods for removing white blood cells from red bland cells prior to transfusion or long term storage.
Haakarouric3 ~f the Triveritxoric Most of the whole blood collected from do-nors today is not itself stored and used for transfusion. Instead, the whole blood is separated into its clinically proven companents (typically red blood cells, platelets, and plasma), which are them-selves individually stored and used to treat a multi-plicity of specific conditions and diseased states.
Far example, the red blood cell component is used to treat anemia; the concentrated platelet component is ~0 used to control thrombocytopenic bleedings and the platelet-poor plasma component is used as a volume expander ox as a source of Clotting Factor VIII for the treatment of hemophilia.
systems composed of multiple, interconnected plastic bags have met widespread case and acceptance in ~(l3~ ~1~~
i~~ 92/2042 P~:'1'/1J~9~/~l~~s %'l the collection, processing and storage of these blood components. In the United States, these multiple blood bag systems are subject to regulation by the government. For example, the plastic materials from which the bags and tubing are made must be approved by the government. In addition, the maximum storage pe-riods for the blood components collected in these sys-tems are prescribed by regulation.
In the United States, whole blood components to collected in a nonsterile, or "open", system (i.e. one that is open to communication with the atmosphere) must, under governmental regulations, be transfused within twenty-four hours. However, when whole blood components are collected in a sterile, or ''closed", system (i.e., one that is closed to communication with the atmosphere), the red blood cells can be stored up to forty-two days (depending upon the type of antico-agulant and storage medium used) ; the platelet concen-trate can be stored up to five days (depending upon the type of storage container); and the platelet--poor plasma may be frozen and stored for even longer peri-ods. Conventional systems of multiple, interconnected plastic bags have met with widespread acceptance, be-cause these systems can reliably provide the desired sterile, "closed°' environment for blood collection and processing, thereby assuring the maximum available st~rage periods.
In collecting whole blood components for transfusion, ft is desirable to minimize the presence of Rmpuxities or other materials that may cause unde-sired side effects in the recipient. For example, ba~cause of p~assible febrile reactions, it is generally ' c~rasidered desirable to transfuse red blaod cells sub' stanta.ally free of the white blood cell co~aponents, particularly for recipients who undergo ~rec~uent WO 92/20~t2~t 'PC"'l'IUJ~'l~,c~;..,! i l -transfusions.
One way to remove ~;ahite blood cells is by washing the red blood cells with saline. This tech-nique is time consuming and inefficient, as it can reduce the number of red blood cells available for transfusion. The washing process also exposes the red blood cells to communication with the atmosphere, and thereby constitutes a "non-sterile" entry into the storage system. Once a non-sterile entry is made in a previously closed system, the system is considered °'opened°', and transfusion must occur within twenty-four hours, regardless of the manner in which the blood was collected and processed in the first place.
In the tTnated States, an entry into a blood collection Z5 system that presents the probability of non-sterility that exceeds one in a million is generally considered to constitute a "non-sterile" entry.
Another way to remove white blood cells is by filtration. Systems and methods far accomplishing this within the context of conventional multiple blood bag configurations are described in Wisdom tl.S. Pat-ents 4,596,657 and 4,767,541, as well as in Carmen et al TJ.S. Patents 4810,378 and 4,855,063. In these arrangements, an inline white blood cell filtration device is used. The filtration can thereby be accom~
plashed in a closed system. However, the filtration processes associated with these arrangements rec;uire the extra step og wetting the filtration device before use with a red blood cell additive solution or the li3ce. This added step complicates the filtration pro-cess and inc;re~ses the processing time.
Other systems and methods for removing white blood cells in the context of closed, multiple blood bag configurations are described in Stewart U.S. Pat ent 4,997,577. In 'these filtration systems and meth-__ ego 9zrzo4zs ~~-rr~~~~a.; ~, J, ; ;
_ ods, a transfer assembly dedicated solely to the re-moval of white blood cells is used. The transfer as-sembly is attached to a primary blood collection con-tainer. The transfer assembly has a transfer contain-s er and a first fluid path leading to the transfer con-tainer that includes an inline device for separating white blood cells from red blood cells. The transfer assembly also has a second fluid path that bypasses the separation device. Tlsing these systems and meth-ods, white blood cells are removed as the red blood cells are conveyed to the transfer container through the first fluid path. The red blood cells, now sub-stantially free of white blood cells, are then con-veyed from the transfer container back to the primary collection container for storage through the second fluid path, this time bypassing the separation deviceo A need still exists for further improved systems and methods for removing undesired matter from blood components prior to transfusion or storage in a way that lends itself to use in closed multiple blood bag system environments.
W a~nma~~ of the ~tr~ve~t~.~n:
The invention provides a multiple container blood collection system for conveniently processing the various components of blood. The system includes a device for separating the undesired matter during processing. The system is arranged so that some com~
ponents can be conveyed through the separation device, while other components can be readily conveyed along other paths that bypass the separation device. The system is a:Lso arranged so that only a single pass through the separation device is required during a given processing sequence.
The invention provides a blood collection system that includes a blood collection assembly, a ;~ ~ ~D .~. ~,~
W~ 9~/20~2~ P"Clf'/lU'~'~~oti.3'; /'l first transfer assembly, and <3 second transfer assem-bly. The First transfer assembly has an empty first transfer container and a second transfer cowtainer that contains an additive salution. The second trans-fer assembly has a third transfer container and a flu id path that leads to the third transfer container and that includes means for separating undesired matter from blood. The system also has flow control means operable in various processing modes for directing fluid flow within the system.
In one arrangement, the flow control means includes four processing modes. In a first mode, the flow control mans directs a first quantity of blood from the blood collection assembly for collection in the first transfer container. In a second mode, the flow control means directs additive solution.from the second transfer container into the blood collection assembly to mix with the quantity of blood remaining in the blood collection assembly. In a third mode, 2o the flow control means directs the mixture of the ad-ditive solution and the remaining blood from the blood collection assembly to the third transfer container through the separation means to remove the undesired materials. In a fourth mode, the flow control means directs a constituent of the blond contained in the first transfer container into the second transfer con-tainer for collection. °
In another arrangement, the flow control means includes five processing modes. In a first 3~ mode, the flow control means directs a first quantity of blood from the blood collection assembly for col lection in the first transfer container. In a second mode, the flow control means directs a first quantity, but not all, of the additive solution from the second transfer container into the blood collection assembly w~ 92i~onzs ~ ~ ~ ~ ..~ ~. ~ ~crius~~'~:~s,.~ _ to mix with the quantity of blood remaining in the blood collection assembly. Tn a third mode, the flow control means directs 'the mixture of the additive so-lution a.nd the remaining blood from the blood collec- .
tion assembly to the third transfer container through the separation means to remove: the undesired materi-als. In a fourth mode; the flow control means directs the remaining quantity of the additive solution from the second transfer container into the 'third transfer container through the separation means, thereby using the remaining additive solution to flush the separa-tion means as it is being conveyed to the third trans-fer container. In a fifth mode, the flow control means directs a constituent of the blood contained in the first transfer container into the second transfer container for collection.
In either embodiment, the second transfer assembly -can include means for venting air from the third transfer container in a path that bypasses the separation means.
Also in either embodi~aent, at least one of the blood collection assembly, the first transfer as-sembly, and the second transfer assembly can comprise an initially separate subassembly, In this arrange-merit, the system further includes means for attaching the separate subassembly to the other parts of the system at tixae of use .
The invention also provides methods of col lecting blood components substantially free of unde sired matter using the systems as just generally de scribed.
The invention provides blood processing sys-tems and methods in which separation is accomplished using a minimum number ~f bags or other containers.
Since the container that serves as the blood additive container prior to separation also serves as a storage container for one of the blood components after separation, economies are realized.
The systems and methods that embody the features of the invention are particularly well suited for use in association with closed blood collection systems and conventional sterile connection techniques, thereby permitting separation to occur in a sterile, closed environment.
While the systems and methods that embody the features of the invention can be used to process all types of blood components, they are well suited for the removal of white blood cells from red blood cells by filtration prior to transfusion or .Long term storage.
According to one aspect of the invention, there is provided a method of collecting blood components comprising the steps of:
collecting blood having the undesired matter in a blood collection container, separating blood in the blood collection container into a first component a.nd a second component that contains the undesired matter, opening communication between the blood collection container and a first transfer assembly having an empty first transfer container and a second transfer container that contains an additive solution intended for the second component, to (i) convey the first component essentially free of the undesired matter from the blood collection container into the Empty first transfer container and (ii) convey the additive solution from the second transfer container into -the blood collection container to mix the additive solution with the second -7a-component that contains the undesired matter, opening communication between the blood collection container and a second transfer assembly having a third transfer container and a fluid path that leads to the third transfer conta_Lner and that includes means for separating the undesired matter from the blood, to convey the mixture of the additive solution and the second component that includes the undesired matter into the third transfer container through the separation means to remove the undesired matter, separating the first component within the first transfer container into first and second constituent parts, and transferring the first constituent part into the second transfer container for storage, bypassing the blood collection container, while retaining the second constituent part in the first transfer container for storage.
According to another aspect of the invention, there is provided a method of collecting blood components comprising the steps of:
collecting blood having the undesired matter in a blood collection container, separating the blood in the blood collection container into a first component and a second component that contains the undesired matter, opening communication between the blood collection container and a first transfer assembly having an empty first transfer container and a second transfer container that contains an additive solution, to (i) convey the first component from the blood collection container into the empty first transfer container and (ii) convey a first quantity the additive solution from -7b-the second transfer container into the blood collection container to mix the additive solution with the second component that contains the undesired matter, opening communication between the blood collection container and a second transfer assembly having a third transfer container and a fluid path that leads to the third transfer container and that includes means for separating the undesired matter from the blood, to convey the mixture of the firsts quantity of additive solution and the second component that includes the undesired matter into the third transfer container through the separation means to remove the undesired matter, and opening communication between the first and second transfer assemblies to convey a second quantity of the additive solution from the second transfer container through the separation means, bypassing the blood collection container into the mixture contained in the third transfer container and thereby flush additional second component from the separation means.
According to a further aspect of the invention, there is provided a blood collection system comprising:
a blood collection assemb~_y, a first transfer assembly comprising an empty first transfer container and a second transfer container that contains an additive solution, a second transfer assembly comprising a third transfer container and a fluid path that leads to the third transfer container and that. includes means for separating undesired matter from blood, and means for directing fluid flow within the system including flow control means operable (i) in a first mode for directing a first -7c-quantity of blood from the blood collection assembly for collection in the first transfer container, (ii) in a second mode for directing additive solution from the second transfer container into the blood collection assembly to mix with the quantity of blood remaining in the blood collection assembly, (iii) in a third mode for' directing the mixture of the additive solution and the remaining blood from the blood collection assembly to the third transfer container through the separation means to remove the undesired materials, and (iv) in a fourth mode for directing a constituent of the blood contained in the first transfer container into the second transfer container bypassing the blood collection assembly for collection.
According to another aspect of the invention, there is provided a blood collection system comprising:
a blood collection assemb_Ly, a first transfer assembly comprising an empty first transfer container and a second transfer container that contains an additive solution, a second transfer assembly comprising a third transfer container and a fluid path that leads to the third transfer container and than includes means for separating undesired matter from blc>od, and means for directing flvuid flow within the system 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 first transfer container, (ii) in a second mode f'or directing a first quantity of the additive solution from the second transfer container into the blood collection assembly to o R
-7d-mix with the quantity of blood remaining in the blood collection assembly, (iii) in a third mode fox° directing the mixture of the additive solution and the remaining blood from the blood collection assembly to the third transfer container through the separation means to remove the undesired materials, (iv) in a fourth mode for directing a second quantity of the additive solution from the second transfer container into the third transfer container through the separation means, bypassing the blood collection assembly, and (iv) in a fifth mode for directing a constituent of the blood contained in the first transfer container into the second transfer container for collection.
According to a further aspect of the invention, there is provided an assembly usab:Le in association with a primary blood collection system, the assembly comprising:
a first transfer container made of a material that, when compared to DEHP-plasticized polyvinyl chloride materials, has a greater gas permeability that is beneficial for platelet storage, a second transfer container that holds an additive solution for red blood cel7.s, conduit means having one branch that communicates with the first transfer container, a second branch that communicates with the second transfer container, and a third branch that: joins the first and second branches and includes means for connecting the conduit means and associated containers to a primary blood collection system, and -7e-means operative, when the conduit means is attached to the primary blood collection system, for directing fluid flow between the conduit means and the blood collection system and including flow control means operative (i) in a first mode for directing a platelet-rich blood component from the primary collection system into the first transfer container;
(ii) in a second mode for directing the additive solution from the second transfer container to the primary blood collection system; and (iii) in a third mode for' directing a platelet-poor constituent separated from the component contained in the first transfer container unto the second transfer container, leaving a concentration of platelets in the first transfer container for storage.
Other features and advantages of the invention will become apparent upon review of the following description, drawings, and appended claims.
Brief Description of the Drawings Fig. 1 is a schematic view of a blood collection system of the present invention;
Fig. 2 is a schematic view of the system shown in Fig. 1 being used to transfer platelet-rich component to an associated transfer assembly;
Fig. 3 is a schematic view of the system shown in Fig. 1 being used to transfer an additive solution from the associated transfer assembly into the red blood cells in the primary collection container;
Fig. 4 is a schematic view of the system shown in Fig. 1 being used to remove undesired matter from the red blood cells in another transfer assembly, while -7f-platelet and plasma separation occurs in the now separated first transfer assembly;
Fig. 5 is a schematic view of the system shown i n F' i rr 1 c..~ ; t- h ~ l l +-1-, o ~ o o r, .~, ; ~ +- .~ ~ r. +- ., ". -. ,-... .. ,-.,..
p pp ~1~~~'; i"~ ._ ~~~~~J~~r~.:r~~~~
tamers separated for the storage of individual compa-nents;
Fig. 6 is a schematic: view of an alternative arrangement of the system shown in Fig. 1, in which the various assemblies comprise initially separate subassemblies that are joined to gather at time of use;
Fag . 7 is an enlarged side sectional view of the sterile connection devices associated with the l0 systems shown in Fig. 6;
Fig. 8 is a schematic view of the system shown in Fig. 1 being used with an alternative step of flushing the separation device with a portion of the additive solution after filtration is completed; and Fig. 9 is broken away sectional view of a filtration device usable in association with.the sys-tem shown in Fig. 1 and having an air bleed channel far venting air from the transfer container.
I3e~o~itatiou of the Pref~~~ed oditnexat~s:
A blood collection assembly 10 is shown in Fig. 1, The assembly l0 comprises a closed blood col-lection system. In the illustrated embodiment, the assembly 10 serves to separate and store the red blood cells as well as the plasma and platelet blood compo-vents by conventional centrifugation technidues, while removing undesired matter from the red blood sells prior to storage. In the illustrated embodiment, the undesired matter is removed by filtration.
As used herein, the term °°filtration°° is in tended t~ include separation achieved by various cen trifugal and non-centrifugal techraic~ues, and not merely "filt:ration'° in the technical sense. Separa tion can occur by absorption, columns, chemical, elec trical, and electromagnetic means. The term °°f:iltra 39 Lion°° is thus broadly used in this specification to 2~~~~~'~
rw~ 9zizo~szs ~crvus9zio~~~~
_ g _ encompass all of these Separation techaiiques as well.
In the illustrated a,nd preferred embodiment shown in Fig. 1, the assembly l0 includes a primary bag or container 16 and various transfer bags or con s tainers 18, 26, and 34 that eras attached to the prima ry bag 16 by integrally attached branched tubing 28.
The tubing 28 is divided by appropriate connectors into branches 29, 30, and 32.
In the illustrated embodiment, flow c~ntrol devices 31, 33, and 35 are provide on the branched fluid flow paths as shown to enable directing of the ' fluid transfers in a desired sequence of steps. In the illustrated arrangement, the flow control devices take the form of conventional roller clamps that are manually operated to open and close the associated tubing paths.
In use, the primary bag 16 (which is also called a donor bag) receives whole blood from a donor through integrally attached donor tubing 22 that car-ries an phlebotomy needle 24. A suitable anticoagu-lant A is contained in the primary bag 16.
The transfer bag 26 contains a suitable storage solution S for the red blood cells. One such s~luti~on is disclosed in Grade et al iJ.s. patent 4,267,269.
The transfer bag 18 is intended to receive the platelet and plasma blood components associated with the whole blood collected in the primary bag 16. .
According to the invention, the transfer bag 1.8 ulti--mately serves as the storage container for the plate let concentrate constituent. Also according to the invention, the transfer bag 26 else ultimately serves as the storage container for the platelet-poor plasma constituent.
Flow control device 33 is located in tubing ~~ ~2izoazg ~ ~ ~'~ .~ ~ ~ ~c~riu~azeo:~~°rr °-30 to control fluid flow to and from the transfer bag 18. Flow control device 35 is lacated in tubing 32 to control fluid flow to and from transfer bag 26.
Tubing 28 and 29 fcarm a flow path to the 5 container 34. This flow path includes an inline fil tration device 40 for separating undesired matter from blood cells. Flow control means 31 is located on ~tub ing 29 which leads to a separation device 40. Accord ing to the invention, the container 34 ultimately l0 serves as a storage container fox the red blood cells after passage through the separation device 40.
The bags and tubing associated with the pro-cessing assembly 10 can be made from conventianal ap-proved medical grade plastic materials, such as poly-vinyl chloride plasticised with di-2-ethylhexyl-phthalate (DEHP). The ends of the tubing may be con-nected by a "Y°' or "T" connectors to form the branched fluid flow paths.
Alternatively, transfer container 18, which is intended to store the platelet concentrate, can be made of polyolefin material (as disclosed in ~ajewski et al U.S. Patent 4,140,162) or a polyvinyl chloride material plasticised with tri-2-ethylhexyl trimel-litate (TENTH). These materials, when compared to DEHP-plasticised polyvinyl chloride materials, have greater gas permeability that is beneficial for plate-let storage.
The blood collection and storage assembly 10, once sterilized, constitutes a sterile, "closed"
system, as judged by the applicable standards in the United States.
When the system 10 is used according to the invention,,whole blood is collected in the primary bag 16. The collected whole blood is centrifugally sepa-rated within the primary bag 16 into a red blood cell component (.designated RBC in Fig. 2) and platelet-rich plasma component (designated P:RP in Fig. 2). During such separation techniques, a.layer of white blood cells (commonly called the "buf:Ey coat" and designated BC in Fig. 2) forms between the red blood cells and the platelet-rich plasma.
In a first processing mode (shown in Fig.
2), the platelet-rich plasma component is transferred by conventional techniques from the primary bag 16 to l0 the transfer bag 18: This tran:~fer is accomplished by opening clamp 33, while closing clamps 31 and 35. In this step, attempts are made to keep as many white blood cells in the primary bag 16 as possible. The transfer of platelet-rich plasma into the first trans-fer bag 18 leaves the red blood cells and the remain-ing white blood cells behind in the primary bag 16.
In a second processing mode (shown in Fig.
3) , the solution 5 is transferred from the transfer bag 26 into the primary bag 16. This transfer is ac complished by closing clamps 31 and 33, while opening clamp 35.
In a third processing mode (shown in Fig.
In a third processing mode (shown in Fig.
4), the mixture of additive solution S and the red blood and white blood cells in the primary bag 16 is transferred into the transfer yag 34 via the separa tion device 40. This transfer is accomplished by closing the clamps 33 and 35 while opening the clamp 31. The red blood cells and additive solution S enter the container 34 essentially free of white blood cells.
It should be appreciated that the filtration means 40 can be used to remove sill types of undesired materials from different types blood cells, depending upon its particular construction. In the illustrated embodiment, the filtration device 40 is intended to w~ ~ziao~~s ~ ~ ~ ~ ~ ~ fl ~criusg~r~~~o~
- iz -remove white blood cells (and preferably also platelets) from the red blood. cells prior to storage.
In this arrangement, the filtration device 40 includes a housing 42 containing a conventional filtration me-dium 44 suited for the removal of white blood cells and platelets from red blood cells. The filtration medium 44 can include cotton wool, cellulose acetate or another synthetic fiber like polyester. The unde-sired matter (i.e., white blood cells and platelets) to are removed from the red blood cells by the filtration device 40.
In a fourth processing mode (shown in Figs.
4 and 5), a constituent of the component contained in the transfer bag Z8 is transferred to the transfer bag 26. In the illustrated embodiment, this processing mode is accomplished by first separating the transfer bags 3.8 and 26 from the system 10 (as Fig. 4 shows).
The separation of the bags is accomplished by forming snap-apart seals in the tubing ,30 that makes up the branched fluid flow path 30 leading to the transfer bags 18 and 26. A conventional heat sealing device (for example, the ~ematron~ dielectric sealer sold by ~aacter Healthcare Corporation) can be used for this purpose. This device forms a hermetic, snap-apart seal in the tubing 30 (this seal is schematically shown by an '~~19 in Figs. 4 and 5). Fxeferably, the donor tubing 22 is also sealed and disconnected in the same fashion (as shown in Fig. 2).
once separated, the platelet-rich plasma un dergoes subsequent centrifugal separation within the transfer bag :L8 into platelet concentrate (designated TIC in Figs. 4 and 5) and platelet-poor plasma (desig nated PFP in Figs. 4 and 5). The platelet-poor plasma is transferred into the transfer bag 26 (by opening the clamps 33 and 35), leaving the platelet concen-pro ~zizo4zs ~~xvus9zi~~~, ~~r 13 °
trace in the first transfer bang 18.
As Fig. 5 shows, the bags 18 and 26 are then themselves separated by forming snap-apart seals "~c"
in the tubing 30 (as shown in Fig. 3) for subsequent storage of the collected components. The transfer bag 34 (containing the filtered red blood cells) is also separated in the same fashion for storage (as Fig. 5 also shows).
Should air become trapped in the transfer bag 34, it may be necessary to transfer the air through path 28 bag into the primary bag 16 before separating the transfer bag 34 from the system 10. As ,.
seen in Fig. 9, an air bleed channel 50 can be incor-porated within the inline filtration deva.ce 40 for this purpose. To prevent flow of the blood cells be ing filtered through this channel in the filtration step, a suitable one-way valve 52 is provided to close the end of the channel near the inflow opening to fil tration device 40. As shown by datted line 54, an air bleed channel separate from the filter could optional-ly be provided. Means such as a clamp 55 can be pro-vidled to open and close bypass line 54 as required.
damp 31 is opened during this step to allow the vent-ed air to proceed into the primary bag 16.
A variation in the method of using the sys-tem shown in Fig. 1 is shown in Fig. 8. In this al-ternative method, whole blood is collected and sepa-rated in the primary bag 16 in the manner previously described. ~'he same, previously described first pro-ceasing mode is employed to transfer the platelet-rich plasma component from the primary bag 16 to the trans fer bag 18 (as Fig. 2 shows). As before, the transfer of platelet-rich plasma into the first transfer bag 18 leaves the red blr~od cells and as many white blood cells as poasible in the primary bag 16.
~~~6 a:~
WO 92/2x428 fCT/US92/03~~d'J'%
- 14 _ In 'the second processing mode of the alter-native method, red blood cell storage solution S is transferred from the transfer bag 26 into the primary bag 16 in the manner previously described (as general-s 1y shown in Fig. 3). However, in the alternative method, not all of the additive solution S is trans-ferred during this processing mode. A portion of the additive solution S is left behind in the transfer bag 26 for use later in the process.
In the third processing mode of the alterna tive method, the mixture of additive solution S and the red blood and white blood cells in the primary bag 16 is transferred into the transfer bag 34 via the separation device 40 in the manner previously de scribed (and as shown by Arrows I in Fig. 8).
In the fourth processing mode of the alter-native method, the remainder of the additive solution S present in the transfer bag 26 is next transferred into the transfer bag 34 via the separation device 40 (as shown by Arrows II in Fig. 8). This transfer is accomplished by opening clamps 31 and 35, while clos-ing the clamp 33.
The fourth processing mode of the alterna tive method serves to flush any red blood cells re tained in the separation device 40 free of the device 40 and into the transfer bag 34. Component yields are thereby enhanced to the fullest extent possible.
In a fifth processing mode of the alterna tive method, constituents of the component contained in the transfer bag 18 are separated and transferred to the bag 26 (now empty of additive solution S) in the manner previously set forth in the fourth process-ing mode of the.first described method (and as shown in Figs. 4 and 5).
~'he quantities of additive solution S trans-- 1f -ferred during the second and fourth processing modes of the alternative method can vary according to the objectives of the procedure. In the illustrated em-bodiment, where a therapeutic unit of red blood cells is processed, about 75 ml of additive solution S is transferred during the second mode, and about 25 ml more additive solution S is transferred during the fourth mode.
In the embodiment shown in Fig. 6, the sys l0 tem 10 comprises three initially separate subassem blies 60, 62 and 64. The subassembly 60 constitutes a blood collection assembly and includes the primary bag 16 and integrally joined tubing 28. The subassem bly 62 constitutes a first tran:afer assembly and in cludes the transfer bags 18 amd 26 with integrally joined tubing 30 and 32 (with associated roller clamps 33 and 35). The subassembly 64 constitutes a second transfer assembly and includes the transfer bag 34, the inline separation device 40, and the tubing 29 (with associated roller clamp 31).
The separate subassemblies 60, 62, and 64 are joined together at time of use to comprise the system 10 shown in Fig. 1. For this purpose, the em-bodiment shown in Fig. 6 includes a means for connect-ing the.initially separate subassemblies 60, 62, and 64 together. The connection means is associated with each of the initially separate subassemblies 60, 62, and 64.
In the embodiment shown in Fig. 6, the con-nection means comprises mating sterile connection de-vices (designated 66a, 66b, 66c a;nd 66d). The devices 66a, 66b, 66c, and 65d (see also Fig. 7) are described in Granzow et al U. S. Patents 4,1-'i7, 723 and 4,.265, 280, The devices 66a and 66d are carried by the tubing 28 of~the subassembly 60. The device 66b is car-ried by the tubing 30 of the transfer subassembly 62.
The device 66c is carried by the tubing 29 of the transfer subassembly 64.
All the sterile connection devices (two of which 66a 'and 66b are shown in Fig. 7 for illustra-tion) each generally includes a housing 70 having a normally closed, meltable wall 72 made of 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 that result in the destruction of bacteria, while at the same time opening a fluid path between the connected housings T0.
The devices 66a, 66b, 66c, and 66d normally close the associated assemblies 60, 62, and 64 from communication with the atmosphere and are opened in conjunction with an active sterilization step which serves to sterilize the regions adjacent to the inter-connecting fluid path as the fluid path is being formed. These devices 66a, 66b, 66c, and 66d also hermetically seal the,interconnecting fluid path at the time it is formed. The use of these sterile con-nection devices 66a, 66b, 66c, and 66d assures a prob-ability of non-sterility teat exceeds one in a mil-lion. The devices 66a, 66b, 66c, and 66d thus serve to connect the subassemblies 60, 62, and 64 without compromising their sterile integrity.
Alternately, the connection means can com prise the sterile connecting :system disclosed in Spencer U.S. Patent 4,412,835 (not shown). In this arrangement, this system forms a molten seal between the tubing ends. Once cooled, a sterile weld is ~ formed.
~t~~~~:1'~
W~ 92/20428 PC°I'/~JS92/0~~" i'l _ 17 _ The subassemblies 60, 62, and 64, once ster-ilized, each constitutes a sterile, "closed" system, as judged by the applicable standards in the United States.
According to the invention, it is possible to direct fluid into and out of the bags :L6, 1B, 26 and 34 in a desired sequence, with only the red blood cell concentrate passing through the filtration device Tt will be understood, however, that in the event filtration of any of the other blood components were to be desired, separation devices could be added to the system for such purposes.
In the illustrated embodiments, the entire filtration process can be accomplished in less than five minutes. All blood components processed are sub stantially free of the undesired matter. In the pre-ferred embodiment, where the all the fluid transfers are made using sterile connection techniques, the pro-cessing and inline filtration have occurred without compromising the sterile integrity of any collected component or reducing their storage life.
Various modifications of the invention will be apparent to those sb~alled in the art within the purview of the following claims.
It should be appreciated that the filtration means 40 can be used to remove sill types of undesired materials from different types blood cells, depending upon its particular construction. In the illustrated embodiment, the filtration device 40 is intended to w~ ~ziao~~s ~ ~ ~ ~ ~ ~ fl ~criusg~r~~~o~
- iz -remove white blood cells (and preferably also platelets) from the red blood. cells prior to storage.
In this arrangement, the filtration device 40 includes a housing 42 containing a conventional filtration me-dium 44 suited for the removal of white blood cells and platelets from red blood cells. The filtration medium 44 can include cotton wool, cellulose acetate or another synthetic fiber like polyester. The unde-sired matter (i.e., white blood cells and platelets) to are removed from the red blood cells by the filtration device 40.
In a fourth processing mode (shown in Figs.
4 and 5), a constituent of the component contained in the transfer bag Z8 is transferred to the transfer bag 26. In the illustrated embodiment, this processing mode is accomplished by first separating the transfer bags 3.8 and 26 from the system 10 (as Fig. 4 shows).
The separation of the bags is accomplished by forming snap-apart seals in the tubing ,30 that makes up the branched fluid flow path 30 leading to the transfer bags 18 and 26. A conventional heat sealing device (for example, the ~ematron~ dielectric sealer sold by ~aacter Healthcare Corporation) can be used for this purpose. This device forms a hermetic, snap-apart seal in the tubing 30 (this seal is schematically shown by an '~~19 in Figs. 4 and 5). Fxeferably, the donor tubing 22 is also sealed and disconnected in the same fashion (as shown in Fig. 2).
once separated, the platelet-rich plasma un dergoes subsequent centrifugal separation within the transfer bag :L8 into platelet concentrate (designated TIC in Figs. 4 and 5) and platelet-poor plasma (desig nated PFP in Figs. 4 and 5). The platelet-poor plasma is transferred into the transfer bag 26 (by opening the clamps 33 and 35), leaving the platelet concen-pro ~zizo4zs ~~xvus9zi~~~, ~~r 13 °
trace in the first transfer bang 18.
As Fig. 5 shows, the bags 18 and 26 are then themselves separated by forming snap-apart seals "~c"
in the tubing 30 (as shown in Fig. 3) for subsequent storage of the collected components. The transfer bag 34 (containing the filtered red blood cells) is also separated in the same fashion for storage (as Fig. 5 also shows).
Should air become trapped in the transfer bag 34, it may be necessary to transfer the air through path 28 bag into the primary bag 16 before separating the transfer bag 34 from the system 10. As ,.
seen in Fig. 9, an air bleed channel 50 can be incor-porated within the inline filtration deva.ce 40 for this purpose. To prevent flow of the blood cells be ing filtered through this channel in the filtration step, a suitable one-way valve 52 is provided to close the end of the channel near the inflow opening to fil tration device 40. As shown by datted line 54, an air bleed channel separate from the filter could optional-ly be provided. Means such as a clamp 55 can be pro-vidled to open and close bypass line 54 as required.
damp 31 is opened during this step to allow the vent-ed air to proceed into the primary bag 16.
A variation in the method of using the sys-tem shown in Fig. 1 is shown in Fig. 8. In this al-ternative method, whole blood is collected and sepa-rated in the primary bag 16 in the manner previously described. ~'he same, previously described first pro-ceasing mode is employed to transfer the platelet-rich plasma component from the primary bag 16 to the trans fer bag 18 (as Fig. 2 shows). As before, the transfer of platelet-rich plasma into the first transfer bag 18 leaves the red blr~od cells and as many white blood cells as poasible in the primary bag 16.
~~~6 a:~
WO 92/2x428 fCT/US92/03~~d'J'%
- 14 _ In 'the second processing mode of the alter-native method, red blood cell storage solution S is transferred from the transfer bag 26 into the primary bag 16 in the manner previously described (as general-s 1y shown in Fig. 3). However, in the alternative method, not all of the additive solution S is trans-ferred during this processing mode. A portion of the additive solution S is left behind in the transfer bag 26 for use later in the process.
In the third processing mode of the alterna tive method, the mixture of additive solution S and the red blood and white blood cells in the primary bag 16 is transferred into the transfer bag 34 via the separation device 40 in the manner previously de scribed (and as shown by Arrows I in Fig. 8).
In the fourth processing mode of the alter-native method, the remainder of the additive solution S present in the transfer bag 26 is next transferred into the transfer bag 34 via the separation device 40 (as shown by Arrows II in Fig. 8). This transfer is accomplished by opening clamps 31 and 35, while clos-ing the clamp 33.
The fourth processing mode of the alterna tive method serves to flush any red blood cells re tained in the separation device 40 free of the device 40 and into the transfer bag 34. Component yields are thereby enhanced to the fullest extent possible.
In a fifth processing mode of the alterna tive method, constituents of the component contained in the transfer bag 18 are separated and transferred to the bag 26 (now empty of additive solution S) in the manner previously set forth in the fourth process-ing mode of the.first described method (and as shown in Figs. 4 and 5).
~'he quantities of additive solution S trans-- 1f -ferred during the second and fourth processing modes of the alternative method can vary according to the objectives of the procedure. In the illustrated em-bodiment, where a therapeutic unit of red blood cells is processed, about 75 ml of additive solution S is transferred during the second mode, and about 25 ml more additive solution S is transferred during the fourth mode.
In the embodiment shown in Fig. 6, the sys l0 tem 10 comprises three initially separate subassem blies 60, 62 and 64. The subassembly 60 constitutes a blood collection assembly and includes the primary bag 16 and integrally joined tubing 28. The subassem bly 62 constitutes a first tran:afer assembly and in cludes the transfer bags 18 amd 26 with integrally joined tubing 30 and 32 (with associated roller clamps 33 and 35). The subassembly 64 constitutes a second transfer assembly and includes the transfer bag 34, the inline separation device 40, and the tubing 29 (with associated roller clamp 31).
The separate subassemblies 60, 62, and 64 are joined together at time of use to comprise the system 10 shown in Fig. 1. For this purpose, the em-bodiment shown in Fig. 6 includes a means for connect-ing the.initially separate subassemblies 60, 62, and 64 together. The connection means is associated with each of the initially separate subassemblies 60, 62, and 64.
In the embodiment shown in Fig. 6, the con-nection means comprises mating sterile connection de-vices (designated 66a, 66b, 66c a;nd 66d). The devices 66a, 66b, 66c, and 65d (see also Fig. 7) are described in Granzow et al U. S. Patents 4,1-'i7, 723 and 4,.265, 280, The devices 66a and 66d are carried by the tubing 28 of~the subassembly 60. The device 66b is car-ried by the tubing 30 of the transfer subassembly 62.
The device 66c is carried by the tubing 29 of the transfer subassembly 64.
All the sterile connection devices (two of which 66a 'and 66b are shown in Fig. 7 for illustra-tion) each generally includes a housing 70 having a normally closed, meltable wall 72 made of 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 that result in the destruction of bacteria, while at the same time opening a fluid path between the connected housings T0.
The devices 66a, 66b, 66c, and 66d normally close the associated assemblies 60, 62, and 64 from communication with the atmosphere and are opened in conjunction with an active sterilization step which serves to sterilize the regions adjacent to the inter-connecting fluid path as the fluid path is being formed. These devices 66a, 66b, 66c, and 66d also hermetically seal the,interconnecting fluid path at the time it is formed. The use of these sterile con-nection devices 66a, 66b, 66c, and 66d assures a prob-ability of non-sterility teat exceeds one in a mil-lion. The devices 66a, 66b, 66c, and 66d thus serve to connect the subassemblies 60, 62, and 64 without compromising their sterile integrity.
Alternately, the connection means can com prise the sterile connecting :system disclosed in Spencer U.S. Patent 4,412,835 (not shown). In this arrangement, this system forms a molten seal between the tubing ends. Once cooled, a sterile weld is ~ formed.
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W~ 92/20428 PC°I'/~JS92/0~~" i'l _ 17 _ The subassemblies 60, 62, and 64, once ster-ilized, each constitutes a sterile, "closed" system, as judged by the applicable standards in the United States.
According to the invention, it is possible to direct fluid into and out of the bags :L6, 1B, 26 and 34 in a desired sequence, with only the red blood cell concentrate passing through the filtration device Tt will be understood, however, that in the event filtration of any of the other blood components were to be desired, separation devices could be added to the system for such purposes.
In the illustrated embodiments, the entire filtration process can be accomplished in less than five minutes. All blood components processed are sub stantially free of the undesired matter. In the pre-ferred embodiment, where the all the fluid transfers are made using sterile connection techniques, the pro-cessing and inline filtration have occurred without compromising the sterile integrity of any collected component or reducing their storage life.
Various modifications of the invention will be apparent to those sb~alled in the art within the purview of the following claims.
Claims (19)
1. A method of collecting blood components comprising the steps of:
collecting blood having the undesired matter in a blood collection container, separating blood in the blood collection container into a first component and a second component that contains the undesired matter, opening communication between the blood collection container and a first transfer assembly having an empty first transfer container and a second transfer container that contains an additive solution intended for the second component, to (i) convey the first component essentially free of the undesired matter from the blood collection container into the empty first transfer container and (ii) convey the additive solution from the second transfer container into the blood collection container to mix the additive solution with the second component that contains the undesired matter, opening communication between the blood collection container and a second transfer assembly having a third transfer container and a fluid path that leads to the third transfer container and that includes means for separating the undesired matter from the blood, to convey the mixture of the additive solution and the second component that includes the undesired matter into the third transfer container through the separation means to remove the undesired matter, separating the first component within the first transfer container into first and second constituent parts, and transferring the first constituent part into the second transfer container for storage, bypassing the blood collection container, while retaining the second constituent part in the first transfer container for storage.
collecting blood having the undesired matter in a blood collection container, separating blood in the blood collection container into a first component and a second component that contains the undesired matter, opening communication between the blood collection container and a first transfer assembly having an empty first transfer container and a second transfer container that contains an additive solution intended for the second component, to (i) convey the first component essentially free of the undesired matter from the blood collection container into the empty first transfer container and (ii) convey the additive solution from the second transfer container into the blood collection container to mix the additive solution with the second component that contains the undesired matter, opening communication between the blood collection container and a second transfer assembly having a third transfer container and a fluid path that leads to the third transfer container and that includes means for separating the undesired matter from the blood, to convey the mixture of the additive solution and the second component that includes the undesired matter into the third transfer container through the separation means to remove the undesired matter, separating the first component within the first transfer container into first and second constituent parts, and transferring the first constituent part into the second transfer container for storage, bypassing the blood collection container, while retaining the second constituent part in the first transfer container for storage.
2. A method according to claim 1 and further including the step, which occurs after the step of conveying the second component into the third transfer container, of expelling air from the third transfer container through a path that bypasses the separation means.
3. A method according to claim 1 and further including the steps of:
separating the first transfer assembly from the blood collection container, separating the first component within the first transfer container into first and second constituent parts, transferring the first constituent part into the second transfer container, while retaining the second constituent part in the first transfer container, and separating the first transfer container holding the first constituent from the second container holding the second constituent.
separating the first transfer assembly from the blood collection container, separating the first component within the first transfer container into first and second constituent parts, transferring the first constituent part into the second transfer container, while retaining the second constituent part in the first transfer container, and separating the first transfer container holding the first constituent from the second container holding the second constituent.
4. A method according to claim 1 or 3 and further including the step of separating the third transfer container from the fluid path that includes the separation means.
5. A method according to claim 4 and further including the step of storing the blood components and constituents in their respective transfer containers.
6. A method of collecting blood components comprising the steps of:
collecting blood having the undesired matter in a blood collection container, separating the blood in the blood collection container into a first component and a second component that contains the undesired matter, opening communication between the blood collection container and a first transfer assembly having an empty first transfer container and a second transfer container that contains an additive solution, to (i) convey the first component from the blood collection container into the empty first transfer container and (ii) convey a first quantity the additive solution from the second transfer container into the blood collection container to mix the additive solution with the second component that contains the undesired matter, opening communication between the blood collection container and a second transfer assembly having a third transfer container and a fluid path that leads to the third transfer container and that includes means for separating the undesired matter from the blood, to convey the mixture of the first quantity of additive solution and the second component that includes the undesired matter into the third transfer container through the separation means to remove the undesired matter, and opening communication between the first and second transfer assemblies to convey a second quantity of the additive solution from the second transfer container through the separation means, bypassing the blood collection container into the mixture contained in the third transfer container and thereby flush additional second component from the separation means.
collecting blood having the undesired matter in a blood collection container, separating the blood in the blood collection container into a first component and a second component that contains the undesired matter, opening communication between the blood collection container and a first transfer assembly having an empty first transfer container and a second transfer container that contains an additive solution, to (i) convey the first component from the blood collection container into the empty first transfer container and (ii) convey a first quantity the additive solution from the second transfer container into the blood collection container to mix the additive solution with the second component that contains the undesired matter, opening communication between the blood collection container and a second transfer assembly having a third transfer container and a fluid path that leads to the third transfer container and that includes means for separating the undesired matter from the blood, to convey the mixture of the first quantity of additive solution and the second component that includes the undesired matter into the third transfer container through the separation means to remove the undesired matter, and opening communication between the first and second transfer assemblies to convey a second quantity of the additive solution from the second transfer container through the separation means, bypassing the blood collection container into the mixture contained in the third transfer container and thereby flush additional second component from the separation means.
7. A method according to claim 6 and further including the steps of:
separating the first component within the first transfer container into first and second constituent parts, and transferring the first constituent part into the second transfer container for storage, while retaining the second constituent part in the first transfer container for storage.
separating the first component within the first transfer container into first and second constituent parts, and transferring the first constituent part into the second transfer container for storage, while retaining the second constituent part in the first transfer container for storage.
8. A method according to claim 6 and further including the steps of:
separating the first transfer assembly from the blood collection container, separating the first component within the first transfer container into first and second constituent parts, transferring the first constituent part into the second transfer container, while retaining the second constituent part in the first transfer container, and separating the first transfer container holding the first constituent from the second container holding the second constituent.
separating the first transfer assembly from the blood collection container, separating the first component within the first transfer container into first and second constituent parts, transferring the first constituent part into the second transfer container, while retaining the second constituent part in the first transfer container, and separating the first transfer container holding the first constituent from the second container holding the second constituent.
9. A method according to claim 6 or 7 or 8 and further including the step of separating the third transfer container from the fluid path that includes the separation means.
10. A method according to any one of claims 6 to 9 and further including the step of storing the blood components and constituents in their respective transfer containers.
11. A method according to claim 7 and further including the step, which occurs after the step of conveying the second component into the third transfer container, of expelling air from the third transfer container through a path that bypasses the separation means.
12. A method according to claim 1 or 6 wherein, at the end of the step of separating the blood in the blood collection container, the first component is platelet-rich plasma, the second component is red blood cells, and the undesired matter is white blood cells.
13. A method according to claim 12 and further including the steps of:
separating the platelet-rich plasma within the first transfer container into platelet-poor plasma and a concentration of platelets, and transferring the platelet-poor plasma into the second transfer container for storage, while retaining the platelet concentration in the first transfer container for storage.
separating the platelet-rich plasma within the first transfer container into platelet-poor plasma and a concentration of platelets, and transferring the platelet-poor plasma into the second transfer container for storage, while retaining the platelet concentration in the first transfer container for storage.
14. A blood collection system comprising:
a blood collection assembly, a first transfer assembly comprising an empty first transfer container and a second transfer container that contains an additive solution, a second transfer assembly comprising a third transfer container and a fluid path that leads to the third transfer container and that includes means for separating undesired matter from blood, and means for directing fluid flow within the system 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 first transfer container, (ii) in a second mode for directing additive solution from the second transfer container into the blood collection assembly to mix with the quantity of blood remaining in the blood collection assembly, (iii) in a third mode for directing the mixture of the additive solution and the remaining blood from the blood collection assembly to the third transfer container through the separation means to remove the undesired materials, and (iv) in a fourth mode for directing a constituent of the blood contained in the first transfer container into the second transfer container bypassing the blood collection assembly for collection.
a blood collection assembly, a first transfer assembly comprising an empty first transfer container and a second transfer container that contains an additive solution, a second transfer assembly comprising a third transfer container and a fluid path that leads to the third transfer container and that includes means for separating undesired matter from blood, and means for directing fluid flow within the system 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 first transfer container, (ii) in a second mode for directing additive solution from the second transfer container into the blood collection assembly to mix with the quantity of blood remaining in the blood collection assembly, (iii) in a third mode for directing the mixture of the additive solution and the remaining blood from the blood collection assembly to the third transfer container through the separation means to remove the undesired materials, and (iv) in a fourth mode for directing a constituent of the blood contained in the first transfer container into the second transfer container bypassing the blood collection assembly for collection.
15. A system according to claim 14 wherein the second transfer assembly includes means for venting air from the third transfer container in a path that bypasses the separation means.
16. A blood collection system comprising:
a blood collection assembly, a first transfer assembly comprising an empty first transfer container and a second transfer container that contains an additive solution, a second transfer assembly comprising a third transfer container and a fluid path that leads to the third transfer container and that includes means for separating undesired matter from blood, and means for directing fluid flow within the system 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 first transfer container, (ii) in a second mode for directing a first quantity of the additive solution from the second transfer container into the blood collection assembly to mix with the quantity of blood remaining in the blood collection assembly, (iii) in a third mode for directing the mixture of the additive solution and the remaining blood from the blood collection assembly to the third transfer container through the separation means to remove the undesired materials, (iv) in a fourth mode for directing a second quantity of the additive solution from the second transfer container into the third transfer container through the separation means, bypassing the blood collection assembly, and (iv) in a fifth mode for directing a constituent of the blood contained in the first transfer container into the second transfer container for collection.
a blood collection assembly, a first transfer assembly comprising an empty first transfer container and a second transfer container that contains an additive solution, a second transfer assembly comprising a third transfer container and a fluid path that leads to the third transfer container and that includes means for separating undesired matter from blood, and means for directing fluid flow within the system 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 first transfer container, (ii) in a second mode for directing a first quantity of the additive solution from the second transfer container into the blood collection assembly to mix with the quantity of blood remaining in the blood collection assembly, (iii) in a third mode for directing the mixture of the additive solution and the remaining blood from the blood collection assembly to the third transfer container through the separation means to remove the undesired materials, (iv) in a fourth mode for directing a second quantity of the additive solution from the second transfer container into the third transfer container through the separation means, bypassing the blood collection assembly, and (iv) in a fifth mode for directing a constituent of the blood contained in the first transfer container into the second transfer container for collection.
17. A system according to claim 16 wherein the second transfer assembly includes means for venting air from the third transfer container in a path that bypasses the separation means.
18. A system according to claim 14 or 16 wherein at least one of the blood collection assembly, the first transfer assembly, and the second transfer assembly comprises an initially separate subassembly, and further including means for attaching the separate subassembly to the other parts of the system.
19. An assembly usable in association with a primary blood collection system, the assembly comprising:
a first transfer container made of a material that, when compared to DEHP-plasticized polyvinyl chloride materials, has a greater gas permeability that is beneficial for platelet storage, a second transfer container that holds an additive solution for red blood cells, conduit means having one branch that communicates with the first transfer container, a second branch that communicates with the second transfer container, and a third branch that joins the first and second branches and includes means for connecting the conduit means and associated containers to a primary blood collection system, and means operative, when the conduit means is attached to the primary blood collection system, for directing fluid flow between the conduit means and the blood collection system and including flow control means operative (i) in a first mode for directing a platelet-rich blood component from the primary collection system into the first transfer container;
(ii) in a second mode for directing the additive solution from the second transfer container to the primary blood collection system; and (iii) in a third mode for directing a platelet-poor constituent separated from the component contained in the first transfer container into the second transfer container, leaving a concentration of platelets in the first transfer container for storage.
a first transfer container made of a material that, when compared to DEHP-plasticized polyvinyl chloride materials, has a greater gas permeability that is beneficial for platelet storage, a second transfer container that holds an additive solution for red blood cells, conduit means having one branch that communicates with the first transfer container, a second branch that communicates with the second transfer container, and a third branch that joins the first and second branches and includes means for connecting the conduit means and associated containers to a primary blood collection system, and means operative, when the conduit means is attached to the primary blood collection system, for directing fluid flow between the conduit means and the blood collection system and including flow control means operative (i) in a first mode for directing a platelet-rich blood component from the primary collection system into the first transfer container;
(ii) in a second mode for directing the additive solution from the second transfer container to the primary blood collection system; and (iii) in a third mode for directing a platelet-poor constituent separated from the component contained in the first transfer container into the second transfer container, leaving a concentration of platelets in the first transfer container for storage.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/704,063 US5269946A (en) | 1991-05-22 | 1991-05-22 | Systems and methods for removing undesired matter from blood cells |
| US7/704,063 | 1991-05-22 | ||
| PCT/US1992/003477 WO1992020428A1 (en) | 1991-05-22 | 1992-04-27 | Systems and methods for removing undesired matter from blood cells |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2086517A1 CA2086517A1 (en) | 1992-11-23 |
| CA2086517C true CA2086517C (en) | 2003-07-08 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002086517A Expired - Fee Related CA2086517C (en) | 1991-05-22 | 1992-04-27 | Systems and methods for removing undesired matter from blood cells |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US5269946A (en) |
| EP (1) | EP0540734B1 (en) |
| JP (1) | JP3172795B2 (en) |
| AU (1) | AU653238B2 (en) |
| CA (1) | CA2086517C (en) |
| DE (1) | DE69216995T2 (en) |
| WO (1) | WO1992020428A1 (en) |
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-
1991
- 1991-05-22 US US07/704,063 patent/US5269946A/en not_active Expired - Fee Related
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1992
- 1992-04-27 DE DE69216995T patent/DE69216995T2/en not_active Expired - Fee Related
- 1992-04-27 AU AU18717/92A patent/AU653238B2/en not_active Ceased
- 1992-04-27 EP EP92917334A patent/EP0540734B1/en not_active Expired - Lifetime
- 1992-04-27 WO PCT/US1992/003477 patent/WO1992020428A1/en active IP Right Grant
- 1992-04-27 CA CA002086517A patent/CA2086517C/en not_active Expired - Fee Related
- 1992-04-27 JP JP51033892A patent/JP3172795B2/en not_active Expired - Fee Related
Also Published As
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|---|---|
| JP3172795B2 (en) | 2001-06-04 |
| US5269946A (en) | 1993-12-14 |
| CA2086517A1 (en) | 1992-11-23 |
| AU1871792A (en) | 1992-12-30 |
| DE69216995T2 (en) | 1997-09-04 |
| EP0540734B1 (en) | 1997-01-22 |
| JPH06500043A (en) | 1994-01-06 |
| EP0540734A1 (en) | 1993-05-12 |
| WO1992020428A1 (en) | 1992-11-26 |
| EP0540734A4 (en) | 1994-07-13 |
| AU653238B2 (en) | 1994-09-22 |
| DE69216995D1 (en) | 1997-03-06 |
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