JPS59501538A - Blood component collection set - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Liquid component collection system and method Separate hair and skin illustration The present invention generally relates to a system and system that enables the collection and separation of whole blood into its therapeutic components. and methods. The present invention also generally relates to semipermeable membrane systems and methods.

Honkouhei 911 Disease & Sales ■Han Currently, more than 12 million units of whole blood come from volunteer donors annually in the United States. collected. With the advent of blood component therapy, approximately 60% to 80% of collected whole blood % is not used for storage and transfusion by itself today. Instead, whole blood is clinically proven ingredients, which themselves have a number of specific conditions. and stored and used individually to treat pathological conditions.

A clinically proven component of whole blood is red blood cells, which can be used to treat chronic anemia, hemophilia For the treatment of platelet poor blood which can then produce a tropic precipitate enriched with blood clotting factors. Contains plasma, and platelet concentrate that can be used for thrombocytopenic bleeding.

The current medical community consensus is that patient care is necessary to treat a specific disease. The goal is to improve by providing only the therapeutic components of whole blood. in this way The demand for therapeutic components of whole blood is constantly increasing. Similarly, the therapeutic components of whole blood Safe and efficient systems and methods for harvesting, separating, and storing Demand for the law has grown accordingly.

One desirable feature for blood collection and separation systems and methods is that - Maximize the yield of clinically proven blood components during the procedure to the greatest extent possible. It is the ability to

Minimum yield requirements for certain ingredients are often prescribed by government regulations. Ru. For example, in the United States, the Federal Regulations (CFR211JN g640, 24 fc l) is the platelet per therapeutic unit in at least 75% of the units tested. and requires the presence of at least 5.5 x 10" platelets. Typically, One unit of platelets contains approximately 50 volumes of plasma as a clouding medium.

Another desirable feature of blood collection and separation systems and methods is long-term storage. It is the ability to obtain ingredients suitable for brewing. This feature is guaranteed by a given blood collection system. It is closely related to the degree of sterility achieved. Such matters are also usually subject to government regulations. This is a contrast.

For example, in the United States, collected and processed in a non-sterile or open system Whole blood and components must be transfused within 24 hours after collection. On the other hand, the United States In , whole blood and red blood cells collected in a sterile or closed system are Depending on the coagulant and storage medium, it can be stored for up to 35 days. Similarly, within a closed system Depending on the capacity of the storage container to maintain appropriate storage conditions, platelets collected at Can be stored up to days and maybe even longer. collected in a closed system The collected plasma can be frozen for longer periods.

In the United States, federal regulations (CFR 21 Part 640.16 fbl) require closed blood collection systems to A system in which sterile blood collection and transfer containers are integrally connected to each other and exposed to the atmosphere from the beginning. It is stipulated that it is not open to communication with. Furthermore, in the United States, closed recruitment To preserve the blood system, the system must be accessed in a non-sterile manner after blood collection. Can not. The probability of non-sterility is greater than 1 in 1 million (i.e. greater than 10-6). Penetration of a blood collection container provided constitutes non-sterile penetration in the United States.

Representative examples of known whole blood collection assemblies include the following US patents:

Earl　3.064.647 Wandell et al 3,078,847Bellamy Jr, 3 ,110,308 Tenczar Jr., 3,187,750 Viguier 3.870.042 Garber et al 3,986,506 Djerassi 4. II L 1995m1th 4,222,379 Representative examples of known commercially available whole blood collection assemblies include the Fenwall, LA Volatories, Inc. (Illinois).

Deerfield's Trahenol, Laboratories, Inc. Department), DelMethod, Corporation and Cali, Irvine, Calif. Cutter, Laboratories, Inc., Berkeley, Fornia It is sold from

All of the above blood collection assemblies are capable of handling each collected unit of whole blood (approximately 450 g). It relies exclusively on non-automated patch centrifugation for separation into species components.

During conventional Hutch centrifugation, the sampled unit of whole blood is separated from the whole blood by containing red blood cells and blood inside it. Initially separated into plasma in which a substantial amount of platelets are present (known as platelet-lynch plasma) is first subjected to centrifugal force for a sufficient period of time to This stage of operation is generally It's called "Tospin."

The platelet-rich plasma is then manually pushed into another container, and the platelet-rich plasma generally longer times to further separate platelet concentrate and platelet-poor plasma. while being subjected to greater centrifugal force.

This stage of operation is commonly referred to as "hard spin."

Plasma otherwise suitable for storage or further fractionation during non-automated batch centrifugation Approximately 100d is lost. A part of this remains with the red blood cells after the soft spin, This is because a part of it is transferred together with the platelets after hard spin. Therefore, the customary Using centrifugation, the volume of autologous collection is not optimized.

Furthermore, S, J, 5lichtqr et al, Br1tish Jo Arnal of Haemat.

-Iogy+ 1976+ 34+ 395-402” Preparati on and Storage of Platelet Concentrate es (Factors Influencing the Harvest o f　ViablePIateleLs　from Whole　Blood)　 As the authors observe in Important for efficient preparation. of platelets from one unit of whole blood without loss of viability. In order to harvest 86%, the author (on page 401 of the said paper) uses 1000G (all Soft spin for 9 minutes at 1000 times gravity) and 3000G A hard spin for 20 minutes was recommended.

Centrifugation operations to optimize platelet yield are thus time consuming.

In addition, skilled technicians are required to calibrate and operate the centrifuges used during these operations. Non-automated batch centrifugation can be labor intensive.

In addition, platelets may lose viability if centrifuged too forcefully and/or for too long. Conventional centrifugal force is sufficient to separate virtually all platelets from the plasma. It is extremely difficult, if not impossible, to generate during a hard spin. example The paper by Lichter et al (page 397) describes the conventional Hutch centrifugal technique. The platelet pool obtained during the procedure was 13,000 to 16,000 per al. It has been observed that platelets are present at concentrations of

The inability of conventional batch centrifugation techniques to obtain plasma that is virtually free of platelets is due to the Leading to further inefficiency in fractional processing.

For example, the presence of platelets in plasma from which a cold precipitate enriched with coagulation factors is obtained Factor 7: Reduces the effective yield of Thus, the conventional Hatch centrifugation technique Platelet-poor plasma produced does not maximize the yield of factor II.

In addition, the presence of measurable platelets in platelet poor blood cells does not necessarily mean that these platelets are Means not present in platelet concentrate. In this way, the conventional Hatsuchi centrifugal technique does not maximize platelet concentrate yield.

Therefore, one of the other desirable features of the blood collection and separation system and method is: The ability to obtain optimal yields of platelets and substantially platelet-free plasma.

A novel blood collection system that uses exclusively non-automated Hutch centrifugation technology to optimize component yields. U.S. Patent Application No. 316,918 filed October 30, 1981 filed on April 30, 1982, and is a partial continuation of ``Increased Yield Blood Collection System''. Ronald A., Williams et a. No. 373.555, published in US Pat.

Novel biochemistry that uses continuous flow centrifugation technology to optimize component yields and associated shelf life. The blood system is a Ronald A. Williams et al., U.S. Patent Application No. 403.832 (1) (filed on July 30, 1982).

Novel collection methods that use porous membranes to perform all or part of increased yield blood collection operations Blood systems and methods entitled: ``Increased Yield Blood Component Collection Systems and Methods'' Bloom et al.'s U.S. patent application and ``Increased Yield Blood Component Collection System'' B115tadet al US Patent Application entitled ``Stems and Methods''. It is. These patent applications share the same filing date and assignee as this application.

With the above considerations in mind, one of the main objects of the present invention is to Guarantees maximum usable shelf life as measured by accepted U.S. standards for In embodiments, the yield of blood components obtained during the - collection operations is maximized to the maximum possible. It is an object of the present invention to provide a blood sampling system and method that maximizes blood sampling.

Another main object of the present invention, in addition to the above attributes, is to provide plasma that is substantially platelet-free. An object of the present invention is to provide a blood collection system and method that provides the following.

Yet another main object of the present invention is that, in addition to any of the above attributes, a given operation A blood sampling system and The purpose is to provide a method.

Yet another major object of the present invention, in addition to the attributes just mentioned, is to We offer a blood collection system and method that does not rely on large and sophisticated processing equipment. It is to provide.

Honko plate ■Kanka To achieve these and other objectives, the present invention provides a method for collecting primarily red blood from blood donors. Blood comprising a first means for collecting for separation into blood cells and platelets Lynch plasma Provides a liquid component collection system. The system also receives platelet phosphate from the first means. receive platelet-rich plasma and convert platelet-rich plasma into platelet concentrate and substantially platelet-rich plasma. and a second means for non-centrifugally separating the plasma into free plasma.

The term "platelet lynch plasma" used here refers to the plasma that is normally found in a donor's whole blood. This means that platelets are present at about twice that concentration. In general, healthy adults Platelet concentration is approximately 200,000 platelets/al of whole blood. In this way, The associated platelet count from blood donors is approximately 400,000 per plasma al. will have a platelet concentration of

As used here, the platelet concentration is approximately 12°000 platelets per plasma μβ. or less, plasma is "substantially platelet-free."

Infusion of platelets at these small concentrations has been proven by the medical community to When comparing the therapeutic effect of platelet injection, it does not have any significant therapeutic effect on the human body. Generally accepted. Thus, the therapeutic value of virtually platelet-free plasma Values can only be attributed to plasma-based components other than plasma and platelets. Contains substantially platelets Not the plasma itself can be injected for therapeutic purposes, or it can be fractionated for purposes of fractionation. It can be used as a source of blood cells.

As used here, the dominant minimum blood cell defined by platelet-governed rules Platelets are in a “concentrated” form when present in concentrations that meet or exceed platelet yield. be.

In a preferred embodiment, the second means comprises for storage the platelet concentrate and substantially It includes means for collecting a volume of platelet-free plasma. This configuration smells The first means also includes means for collecting a volume of red blood cells for storage.

In a preferred embodiment, each of the blood component collection means has an associated collection means. Includes means for imparting physical properties beneficial to the intended function. for example, The physical properties imparted to the collection means for platelet concentrates result in improved platelet production. Contains improved gas permeation properties for retention and virtually platelet-free plasma The physical properties imparted to the collection means facilitate the freezing of plasma that is virtually free of platelets. Contains a relatively high cold strength to make the red blood cells The physical property that is important is the inhibition of hemolysis of red blood cells during storage.

In a preferred embodiment, the first means comprises an in vitro blood processing device for undergoing centrifugation. and container means operative for placement within the centrifuge chamber of the station. In this configuration , the second means is preferably designed to filter cellular components from non-cellular components of the blood. and a moving porous membrane means. Oral transfer of platelets (cellular components) from plasma (non-cellular components) can occur virtually instantaneously, so that when involved in the centrifugation of these components, Significant time savings are achieved compared to

Systems embodying features of the invention can be used in non-automated batch centrifugation or continuous flow processes. Applicable for use in either environment.

In continuous flow embodiments, the first means includes means for returning red blood cells to the donor. Including further. The first step is also to remove some volume of red blood cells from the donor for storage. It may include means for flowing the same amount of water. Preferably, the red blood cell diversion means is a storage Contains physical properties that inhibit hemolysis of middle red blood cells.

In the most preferred embodiment, the system will It consists of a fixed closed system. The components sampled into this system are therefore Can be stored.

The present invention also provides for centrifuging a volume of whole blood into primarily red blood cells and platelet lynch plasma. and then platelet lynch plasma with platelet concentrate and substantially remove platelets. Provided is a method for collecting blood components, which includes a step of non-centrifugally separating blood components from non-containing plasma.

Preferably, each step is performed in a manner that does not expose the whole blood and its components to communication with the atmosphere. It will be implemented based on

Systems and methods embodying features of the invention each include substantially platelets. plasma, thereby requiring significantly less time and effort than conventional centrifugation. Maximize platelet yield in embodiments involving force.

Other features and benefits of the invention may be found in the specification as obvious modifications of the embodiments shown in the drawings. as pointed out in or obvious from the description and claims.

plate blood disaster sly skin FIG. 1 depicts a functional block diagram of an increased yield blood component collection method embodying features of the present invention. FIG.

FIG. 2 shows an extension that embodies features of the invention and is capable of implementing the method shown in FIG. FIG. 1 is a functional schematic diagram of a high-volume blood component collection system.

FIG. 3 illustrates an alternative method embodying the features of the invention and capable of implementing the method shown in FIG. FIG. 1 is a functional schematic diagram of an increased yield blood component collection system. Figure 4 shows a partial breakdown of the porous membrane means associated with the systems shown in Figures 2 and 3. FIG. 3 is an enlarged side view of a partial cross section.

FIG. 5 shows a partially broken, partially cross-sectional end of the porous membrane means generally taken along line 5--5 of FIG. It is a front view.

FIG. 6 shows an increased yield blood component collection system embodying the features of the system shown in FIG. FIG. 3 is a partially cutaway, partially sectional plan view of the assembly.

FIG. 7 shows an increased yield blood component collection system embodying the features of the system shown in FIG. FIG. 3 is a plan view of the assembly.

FIG. 8 is an enlarged view of a portion of the assembly shown in FIG. 6;

FIG. 9 illustrates a means of connectors associated with assemblies in uncoupled relationship; FIG. 7 is an enlarged, partially broken, cross-sectional view of a portion of the assembly shown in FIG. 6;

FIG. 10 shows the connection and the use of radiant energy to open a fluid passage therethrough. A portion of the connector means shown in Figure 9 is partially broken and exposed to the Lugy-induced melting apparatus. It is a partial cross-sectional enlarged view.

FIG. 11 shows the connector shown in FIG. 1O after a fluid passageway has been opened therethrough. FIG. 2 is an enlarged view of a partially cutaway section of the means.

Before describing specific examples of the present invention in detail, the present invention will be described below in its application. are limited to details of construction and arrangement of elements herein or illustrated in the accompanying drawings. It should be understood that this is not possible. The invention is capable of other embodiments and may vary. It is possible to implement this method using the following method. Additionally, the words used here are for descriptive purposes only. It should be understood that these terms and conditions are for the purposes of this article and should not be considered limiting.

4B of a favorable day A blood component collection method embodying features of the present invention is illustrated in FIG. The method is , involves the process of separating a certain volume of Friday into mainly red blood cells, platelets, and blood cells. nothing. The method then prepares platelet-rich plasma with platelets and substantially platelet-free. It includes a step of separating into plasma.

The method preferably comprises red blood cells, platelet concentrates and substantially platelet-free plasma. each containing an additional step of collecting for storage or further fractionation.

Methods embodying features of the invention preferably first prepare whole blood rich in red blood cells and platelets. Use a conventional non-automated batch centrifugation technique, soft spin, to separate plasma and . However, other comparable techniques may be used to perform this initial separation. can be done.

Methods embodying features of the invention are also preferably combined with centrifugal soft spin. The platelet lynch plasma is separated into platelet concentrate and substantially platelet-free plasma by non-centrifugation. A later separation process is used.

Examples of non-centrifugal separation techniques are membrane filtration, glass fiber filtration and depth filtration, as well as absorption Including the use of columns, chemical separation, electrical separation and electromagnetic separation. these passages In particular, membrane filtration is the preferred technique.

The method also includes returning the red blood cells to the donor to achieve a continuous flow configuration. You can In this working environment, the method transfers a volume of red blood cells from the donor to Optionally, an additional step may be included to divert the water to others for storage purposes.

Preferably, each step of the method is performed in a manner that does not expose the blood components to communication with the atmosphere. It will be implemented based on the maximum permissible storage for each of the components collected thereby; You get time.

Significant features and benefits of the method just described include enhancements embodying features of the invention. More will become clear after the following description of the high-volume blood component collection system.

Reference is now made to FIGS. 2 and 3. There is one blood component collection system each. 0 and 12 are shown. Each of systems 1o and 12 is of the invention. The features can be implemented and the method illustrated in FIG. 1 implemented. Figure 2 System 1o, shown in Figure 1, is best suited for use in conjunction with non-automated centrifugation operations. ,are doing. The system 12 shown in FIG. 3 is used in conjunction with continuous flow centrifugal operations. best suited for

Attention is first directed to the system 10 shown in FIG.

As shown in FIG. 2, the system 10 primarily uses red blood cells and platelet-rich blood. A first step to collect an amount or unit of red blood cells from a donor for separation into plasma. means 14 or portions. Typically, the volume will contain about 450 blood whole blood. Can be done.

The system 10 receives the platelet-rich dish from the first means 14 and receives the platelet-rich dish from the first means 14; Non-centrifugally convert platelet plasma into platelet concentrate and substantially platelet-free plasma. It includes a second means 16 or portion for separating.

The first and second means 14 and 16 can be configured in various ways. However However, the specific example illustrated (which corresponds to the preferred specific example of the method described so far) 2), the first means 14 comprises a centrifugation chamber 2, both shown schematically in FIG. operative for use with an in vitro hatch blood processing device 18 having an o. Second Means 16 is to take an oral passage to perform further separation of platelet-rich blood'IN. porous membrane means 22 for use and operative for attachment to external pump means 24; include. More specifically, the porous membrane means 22 of the second means 16 contains non-cellular components (blood act to evacuate cellular components of blood (such as platelets) from blood (such as plasma) .

In this preferred configuration, the first means 14 includes a device 18 for undergoing centrifugation. It includes a centrifuge vessel 26 suitable for placement within the separation chamber 20 .

The first means 14 has a first means communicating with the inlet bow 1-30 of the centrifuge vessel 26 at one end. It further includes one branch conduit means 28. The first technique 28 is a venous cut at the other end. It communicates with the open needle 32. Whole blood is collected from the donor using the first technique 28 and sent to a centrifuge container 26. will be introduced to

The phlebotomy needle 32 can be integrally connected to the branch conduit means 28 and is fitted with a conventional needle cover 34. or by a sheath (not shown in Figure 2 but shown in Figure 6) It is possible that the Cover 34 is removed during venipuncture.

Instead, the branch conduit means 28 includes Trahenol of Deerfield, Illinois. Fenwall, a division of Laboratories, Inc. Fenwall Blood Sold by Volatories, Inc. Includes a conventional needle adapter (not shown), such as that provided in the fluid recipient set. You can

Whole blood introduced into container 26 coagulates. Conventional anticoagulant solutions to prevent A volume (such as an ACD or CPD) is supported within the container 26.

Whole blood introduced into the container 26 is subjected to a centrifugal force field generated within the chamber 2o. Already Due to the difference in density, the whole blood components are separated and radially away from the axis of rotation of the chamber 20. The desired separation of the components collected in the vessel 26 into separate and different zones is achieved by the large centrifugal force generated. Depends on the size. 5orvall R at 1900PPM (1000G) By using a C-3 centrifuge (HG-4L rotor), whole blood can be collected in approximately 6 minutes. red blood cells (which collect in zone 38 of container 26) and platelet-rich plasma (which collects in zone 38 of container 26); (collecting in zone 40 of container 26).

In a preferred configuration, the second means 16 comprises a platelet-rich platelet extract from the zone 40 of the centrifuge container 26. A second technique 42 is included for discharging blood into the porous membrane means. The second technical means 42 is Platelet-rich plasma is introduced into the pump means 24 for introduction into the porous membrane means 22. It includes a portion 43 that is operative for attaching.

In this configuration, the red blood cells are preferably left in the centrifuge container 26 for storage.

The porous membrane means can be constructed in a variety of ways. In the illustrated example, As best shown in FIGS. 4 and 5, the membrane means 22 has a It includes a tubular housing 44 to which a bundle of porous hollow fiber membranes 46 is attached.

Membrane 46 is preferably as described in Mahon U.S. Pat. No. 3,228,876. is mounted within the housing 44 using conventional potting techniques, such as It will be done.

During the potting operation described in the above patent, a liquid, typically polyurethane, Body botting compound 48 is applied around and between the ends of the individual fibers. is introduced into both ends of the housing 44 (the first (See Figure 5). The penetration of the botting compound 48 into the bore of the fiber end 47 is , which can be prevented by various means such as those discussed in the Mahon patent cited above. can.

After the potting compound 48 has hardened and the fiber ends 47 have been opened, the ends Caps 50 and 52 may be sealed to the potted ends of housing 44. can. An inlet port 51 is formed on the end cap 50 and an outlet port 5 3 is formed on the other end cap 52.

Surrounding the outer periphery of the bundle of hollow fiber membranes 46 is an empty volume 54 (see Figure 4), which are sealed by each line with hardened potting compound 48. . An outlet boat 56 communicates with this volume 54.

Porous hollow fiber membranes from it to achieve separation of cellular components of blood from non-cellular components The material that can be used to make it is certain thermoplastic polymers such as polypropylene. Including mar. These materials can be prepared by known methods such as solution spinning or melt spinning. can be formed into hollow fibers.

For example, polypropylene hollow fibers have a wall thickness of about 50 microns and a wall thickness of about 320 microns. an inner diameter of approximately 0.55 microns, a maximum pore diameter of approximately 0.30 microns, and an average pore diameter of approximately 0.30 microns. It is possible to manufacture products with Such hollow fibers were produced by the West German Enk a. Commercially available from AG and well suited for the purposes described herein.

In an alternative embodiment (not shown), the membrane means 22 has the same or comparable porous structure. The device can take the form of a separate generally flat membrane made of the material. the An example of such a device is U.S. Pat. No. 4,313,81 to Edelman et al. It is disclosed in No. 3.

The second technique 42 directly transfers the platelet-rich dish from the centrifuge container 26 to the porous membrane means 2. 2 (see e.g. system 12 in FIG. 3). ). However, in the embodiment of FIG. 2, the second technique 42 means 56 for temporarily collecting or pooling the plasma before sipping. This program The pool means 56 communicates with the pool vessel 58 and with the zone 40 of the centrifuge vessel 26. Communicating with the outlet boat 62 at one end and the inlet of the pool vessel 58 at the other end A first transfer conduit means 60 is included in communication with a port 64.

The pooling means 56 includes a first transfer conduit for controlling the transfer of platelet lynch blood. In-line with stage 60, a valve hand such as a manual roller clamp or hemostatic forceps It further includes a stage 66. This transfer manually transfers the platelet-rich mixture to the container 2 after centrifugation. This can be achieved by extruding from 6. A pump for the same purpose (see diagram) ) can be used.

The pool means 56 also, in this configuration, connects the inlet port of the membrane means 22 at one end. communicates with port 51 and does not communicate with outlet port 70 of pool container 58 at the other end. It further includes a second transfer conduit means 58. In the illustrated embodiment, the second transfer conduit operatively connecting the portion 43 located along the step 68 with the external pumping means 24; This allows the platelet-rich dish shape to be introduced into the membrane means 22 for oral passage. Ru.

Again a valve means 72, such as a roller clamp or hemostatic forceps, controls this transfer. A second transfer conduit means 68 is provided in-line to do this.

The pump means 24 can be configured in various ways. However, all of the collection purposes of System 10 are The operative contact between the conduit section 43 and the pump means 24 is damage the sterile integrity of the system, as determined by US standards, or It must not be opened in any other way.

In the illustrated embodiment, the pumping means is manufactured by Ronal Systems. Conventional peristaltic pumps, such as those manufactured and sold under the trade name Mini Pump. take shape. The pump repeatedly compresses and expands the tubing section and pumps whole blood into the hollow It serves to flow into the fiber membrane 46.

By controlling pump speed, cells are separated from non-cellular components (i.e. blood cells). Hollow fibers with suitable flow characteristics to generate efficient separation of components (i.e. platelets) It can be maintained within the membrane 46.

The blood scene, which is substantially free of platelets, collects in the empty volume 54. blood in a concentrated form during The platelet exits exit port 53.

The separation of virtually all platelets from platelet lynch plasma is accomplished by platelet lynch plasma membrane means. Since the crossings of 22 and 22 occur almost simultaneously, significant time savings can be made using system 10. It can be realized using Additionally, system 10 performs a second separation step. Labor savings are achieved as only one peristaltic pump is required to Can be done.

Significantly, the plasma that collects in volume 54 is substantially free of platelets, so The number of platelets present in the concentrate exiting 53 is determined by system 10 to the highest possible extent. maximized to the maximum.

The second means 16 also preferably includes the first transfer container 74 or containers 74 ( ) from the volume 54 into the first transfer vessel 74 for storage or ■ Contains an associated third technique 76 for transfer to a rich cryoprecipitate for further fractionation. nothing.

The second means 16 also preferably include a second transfer vessel or vessels 78 (dotted line). ) and transfer the platelet concentrate from outlet port 53 to second transfer vessel 78 for storage. It includes an associated fourth technique 80 for transferring into.

System 10 also preferably includes a source of sterile saline solution 82 and a source of saline solution upstream of porous membrane means 22. and branch conduit means 84 communicating with second means 16 at. The saline solution is membrane means 22 and expel air from the second means 16 before sampling. Emission guide Conduit means 85 is preferred for circulating the saline priming volume back to the saline source 82. or can be prepared.

Additional valve means 86a, b, c, d and e carry out the method shown in FIG. the first, third and third respectively to direct the flow of fluid through the system 10. and fourth branch conduit means 28, 76 and 80, and priming branch conduit means 84. and in-line with the discharge conduit means 85. Valve means 86a-e can take the form of manual roller clamps or hemostatic forceps.

To further enhance storage of components collected by system 10, centrifuge vessel 26 a first transfer container 74 (into which the red blood cells are collected); platelet-free plasma is collected), and a second transfer vessel (within which the platelet concentrate is collected). (from which the condensate is collected) each has a value that is beneficial to the intended storage function of the container. Defined physical characteristics are intentionally imparted. This aspect of the invention will be described in detail later. It will be posted.

In the specific example shown in FIG. 2, first, second, third and fourth branch conduit means 2 8.42.76 and 80, plus priming branch conduit means 84 and discharge conduit. Means 85 are each made of a blood compatible plastic material such as plasticized polyvinyl chloride. takes the form of a length of flexible tubing or conduit made of material.

Preferably, each length of tube or conduit is closed from communication with the atmosphere. system 10 provides a fluid passageway in which the blood collection operation is performed in a non-sterile manner. After that, it will not be invaded. Once sterilized, the system 10 will meet all applicable regulations within the United States. It is judged based on the class and constitutes a sterile closed system. For this reason, the components collected are Can be stored for hours.

However, all or part of system 10 may be open to communication with the atmosphere. or the system 1o is penetrated in a sterile manner during the course of operation, and It should be recognized that the components can be collected in essentially the same manner.

However, red blood cell and platelet concentrates collected in an open system must be collected for 24 hours. It will have to be re-injected within a short period of time. Similarly collected substantially platelet-containing The unused plasma can only be used for fractionation purposes (which includes a subsequent sterilization step).

The system 10 shown in FIG. 2 can be manufactured and sold in a variety of configurations. illustrative a Assembly 88 is shown in FIG.

In FIG. 6, assembly 88 is initially composed of seven separate subassemblies (88a (specified by g). Subassemblies 88a-g are operator can be combined and connected to form the system 1° shown in Figure 2. Wear.

In this configuration, each subassembly 88a-g is preferably tear-protected. It is housed in a bag 90 in which each subassembly is sterilized. Outer bag 90 is used When removed. Outer bag 90 also contains fluids present in any of the subassemblies prior to use. Evaporation (such as the saline solution in subassembly 88f) is preferably prevented.

In this configuration, assembly 88 is a subassembly or formed system 1 0 normally separate subassemblies 88 in a manner that does not compromise the sterile integrity of the whole. Means 92 is included for selectively establishing fluid passage between a and g.

More particularly, means 92 includes one or more connectors associated with each subassembly. means 94. The connector means 94 is supported within the contour of the tear outer bag 90 before use. Ru.

As best seen in FIGS. 5-8, each connector means 94 has its own Selectively mechanically connect associated pairs of connectors such that portions 98 are in face-to-face contact. It includes means 96 for coupling.

The facing portions 98 form a fluid passageway through the mated pair of connector means 94, and melts to open fluid communication between the various subassemblies, but It is energy efficient itself to effectively sterilize stages 100 as they melt. - includes means 100 for activating only in response to exposure to a source. This is the fluid passage constitutes an active sterilization process that occurs simultaneously with the formation of

Further, during the melting action, the means 100 preferably seals around the periphery of the fluid passageway. act to fuse to form a cell. The connections formed are therefore internal Sterile and closed from communication with the atmosphere.

Connector means 94 can be configured in a variety of ways and may employ a variety of actuation means. death However, in order to meet the desired yield increase objectives of system 10, the connector Each stage 94 must meet several operational requirements.

More specifically, each connector means 94 (11) has a large associated subassembly. (2) an area adjacent to the fluid passage when the fluid passage is formed; and (3) it must be able to hermetically seal the fluid passageway when it is formed.

U.S. Patents 4.157.723 and 4,265 to Granzow et al. It has been determined that the sterile connectors generally described in 280 meet all of the above criteria. and for that reason such connectors are shown in the illustrated embodiment. Ru.

The construction and operation of such a connector is best seen in FIGS. 9-11. Ru. It is used to join subassembly 88e with subassembly 88c. A connector means 94 is shown. related to other subassemblies. It should be appreciated that all connector means 94 operate in the same manner.

More particularly, each connector means 94 is in communication with its associated subassembly. It includes a housing 102 with a hollow interior 104. The melting described so far The obtaining means 100 takes the form of a meltable wall means and its associated interior and its The subassembly is normally sealed or closed from communication with the atmosphere.

The housing further communicates with the interior 104 and has an associated connector means 94. A tube that serves as an interconnect to a length of tube that is part of a subassembly. It includes a tubular conduit section 106.

The connector means 94 can be connected to the end of the tube in a variety of ways, but the In the embodiment, there is a sealing friction fit between the tubular conduit sections 106. . An elastic band 108, such as made from a latex material, is attached to the tubular portion 1 06 and the respective tubes to ensure a fluid-tight sealing fit. Preferably, the outer periphery of the part is surrounded.

In this configuration, the connector typically prevents fluid flow communication with the interior of the means 94. , an in-line valve member 110 (shown in dotted lines in FIG. 5) may be provided. . Such a configuration is particularly desirable in combination with fluid-filled containers.

Valve member 110 may be configured in a variety of ways, but in the illustrated embodiment it is a Bay Ham et al. U.S. Patents 4,181.140 and 4,294,247 It takes the form of an in-line rupture valve member, such as that disclosed.

Instead, the rupture valve member IIO is manufactured by Granzow et al. No. 4,265,280 of the connector housing 102. It can constitute an integral part.

In the illustrated embodiment, the wall means 100 is molded from a radiant energy absorbing material. . It is therefore activated to melt in response to exposure to a radiant energy source. . Furthermore, the material from which the wall means 100 is made may be affected by any surfacing on the surface of the material. Only at temperatures (i.e. above 200°C) that result in rapid destruction of Tatteria contamination. Deliberately preselected to melt. through the housing 140. Housing 1 to allow transmission of radiant energy to fusible wall means 100 02 is made of materials that do not absorb selected specific types of radiant energy. In a preferred embodiment, the wall means 100 is manufactured by Mitsui Chemicals, Inc. under the trademark TPX. Made from a material molded from commercially available poly(4-methyl-1-pentene). It will be done. This material has a crystalline melting point of approximately 235°C and is described by Boggs et al. Further discussion is provided in US Pat. No. 4,325,417. The material of the wall means 100 is It is colored black to absorb infrared rays. The housing 102 allows radiation to pass through. are made of transparent TPX material, which is generally transparent.

As best seen in FIG. 8, the connection means 96 is a mating bayonet type connection. form, which brings those radiant energy absorbing wall means 100 into face-to-face contact (FIG. 7). ) and act to interlock the connector means 94 together. Ru. Incandescent quartz crystals are concentrated onto the light absorbing wall means 100, which in the illustrated embodiment is inappropriate. When exposed to a radiant energy source comprising lamp 112, the radiant energy absorbing wall Means 100 melts and coalesces as seen in FIG.

During the melting process, the wall means 100 passes through the connector means 94 and becomes immediately sterile. closed and sealed, establishing a fluid path closed to air and communication with the atmosphere. An opening 114 is formed.

As Example 1 below demonstrates, the use of the illustrated connector means 94 is 10- Ensure non-sterility is established for more than 6 days.

Example 1 1.5x10s Bacillus 5ubtilis var per relative A methanol suspension of P. niger (globiguii) spores was prepared. this The microorganism was chosen because of its high dry heat resistance (Angelotti et al. ,, “Influ-ence of 5pore Master Conte nt on the Dry Heat Re5istance of Baci llus 5ubtilis var niger” + Appl, Mi Crobiol, Idol 16 (5th edition: 735-745.1968) .

80 unconnected connector means 94 shown in FIGS. 8 to 11. B, 5ub-Lilis va for one sterile connector part (i.e. 40 pairs) 0.01 d of R. niger (globiguii) suspension was inoculated. child This allows the attached wall means 100 of each connector member to contain about 1 million spores of the microorganism (i.e. 106).

Forty inoculated unconnected connectors were attached to each named sterile container. . The other 40 (llil are each sterilized microbial growth medium (soybean casein digested) It was attached to a container containing SCD broth).

This inoculated pair of connector parts will hereinafter be referred to as the test connector. .

16 additional non-interlocking sterile connector parts (i.e. 8 pairs) are methanol. was inoculated. Eight of these connectors should be attached to empty sterile containers, and the other f[lil was attached to a sterile container containing SCD broth. These will be tested as negative pairs. I'll call it the reference connector.

Connect the test connectors and make 40 connections between the empty container and the SCD broth container. Formed. Also connect the uninoculated negative control connector and connect the empty container to the SCD broth. Eight connections were made between Each connection fuses the crotch and opens the fluid passageway. For this purpose, it was placed in the light-induced melting apparatus described above. The medium was then passed through the connection.

Eight additional and previously fused connector pieces were inoculated as positive controls.

Two of these connectors have a connection force of 106 B, 5 ubtilis va Inoculated with a theoretical challenge of R. niger (globiguii) spores, two Inoculate the theoretical challenge of 10' spores with connecting force, 2 spores with connecting force of 10'l [l il spore theoretical challenge, two are connected force or 101 spore theoretical challenge. Inoculated against war. Media was flowed through the fluid passages of these positive control connectors.

All units were dried in-house for up to 7 days at approximately 32-37°C.

After incubation, all =-=S broths were re-incubated on SCD agar and approx. Incubate at 2-37°C for 18-24 hours. Reculture is a finger The specimens were examined for the presence of orange colonies, which are characteristic of the microorganisms.

No cloudy broth was observed when inspecting the 40flil test connection. Ta.

All eight baggage controls remained negative during incubation.

All eight positive controls showed growth of the indicator microorganisms at all inoculation levels.

Referring again to assembly 88 shown in FIG. 6, various subassemblies 88a, etc. Two or more pieces of Ishig are connected together during manufacturing, so that the operator can connect them all. It should be recognized that it is possible to reduce the total number of subassemblies.

For example, in an alternative embodiment, subassemblies 88a and 88b (centrifuge vessel 26 and pool container 58) may constitute an integrally connected unit 89.

Unit 89 can be placed within centrifugation chamber 20 .

In this alternative embodiment, subassemblies 88c, d and e (first and first 2 transfer vessels 74 and 78 and the porous membrane means 22) are connected to the unit 89. may be another integrally connected unit 91. Unit 91 is centrifugal medium speed remains outside the ventricle and connects to unit 89 after centrifugation has taken place (using a pair of connector means 94).

After the various ingredients have been collected into containers 26.74 and 78, each container is preferably Seal closed and separated from system 1o. This is a hand seal chestnut Also, using a separate pair of tops (not shown)! Mafen Wall, Laboratory using a Hematron high-frequency sealer (also not shown) that is V-reflected from the Achieved by utilizing conventional means such as by forming a hermetic cutting seal using can do.

As previously explained, in the preferred embodiment, each component collection container 26.14 # and 78, at least a portion of which may benefit the intended storage function of the particular container. It is given certain physical properties.

For example, to maximize the storage time of blood 5B, which is substantially platelet-free, the transfer container 74 is preferably a relatively high grade material that withstands long-term freezing in a dish-shaped form substantially free of platelets. Made of material with high low temperature strength.

Candidate materials for this purpose are low-density polyethylene, and large-sized polypropylene. Contains a copolymer of polyethylene and polypropylene containing a partial amount.

To maximize the allowable storage time of platelet concentrate collected in system 10, blood A platelet concentrate is stored therein. Transfer container 78 is preferably used for long-term platelet storage. It has beneficial gas permeation properties for storage.

More specifically, the transfer vessel 78 contains di-2-ethylhexyl phthalate (DB ’HP) preferably has gas permeation properties. There will be.

For example, the transfer container 60a+ is described in U.S. Pat. 140゜162, or -arn trimerisol as described in U.S. Pat. No. 4,280,497 of Eret al. Polyvinyl chloride containers plasticized with tri-2-ethylhexyl (TEHTM) can be included.

Alternatively or additionally, the platelet transfer container 78 maintains platelet survival during storage. A platelet storage medium (not shown) suitable for holding the platelets may be included.

To enhance storage of red blood cells, centrifuge container 26 preferably prevents hemolysis of red blood cells during storage. Made of materials known to suppress. Candidate materials for this purpose are G2-E (DEHP) plasticized polyvinyl chloride.

Alternatively or in addition, an additional transfer vessel 116 (subassembly 116 in FIG. (shown as part of the assembly 88g) is connected to the centrifuge vessel 2 using a connector means 94. 6. This transfer container 116 is used to suppress hemolysis during storage. Contains a suitable isotonic red blood cell storage solution (designated S in Figure 6). This solution S is , is introduced into the red blood cells remaining in the Riko container 26 after the platelet-rich bloodstream has been removed. Ru.

Solution S was prepared by Grode et al., U.S. Pat. No. 4,267.269, or filed May 11, 1982 and entitled "Red Blood Cell Storage Solutions and Methods" No. 377.110 of Grode et al. Ingredients like salt, adenine, mannitol and glucose can include.

Red blood cells are collected using system 10 (and associated subassemblies). As a result, the system 1o can process whole blood from individual donors.

Attention is now directed to the blood component collection system 12 shown in FIG. system 1 2 shares many elements in common with system 1o shown in FIG. These common elements are given a common reference number.

Similar to system IO of FIG. 2, system 12 handles whole blood primarily red blood cells and comprising a first means 14 or part for collecting for separation into platelet-rich plasma; nothing. However, in system 12, pump means 117 pumps blood into a centrifuge container. 26.

Also similar to system 10, system 12 obtains platelet-rich plasma from a first means. the platelet-rich plasma as a platelet concentrate and substantially platelet-free. and a second means 16 or portion for non-centrifugally separating the blood plasma.

Similar to system 10, second means 16 of system 12 depletes cellular components of the blood. It includes porous membrane means 22 for filtration of cellular components.

However, unlike the system 10 shown in FIG. Stage 14 includes an in vitro blood processing device 19 capable of processing blood in continuous flow operation. Operates for use together. An example of such a device is Cullis et a. No. 4,146,172 and 4,185,629 .

Examples of commercially available equipment are both manufactured by Fenwall Laboratories. C5-300 Blood Cell Separator and Cell Refuge manufactured and sold by ■It is a blood cell separator.

In order to accommodate continuous flow operation, the first means 14 of the system 12 is configured to supply red blood cells. A fifth technique 118 is included in communication with the centrifuge container 26 for return to the person. valve hand A stage 120 is provided in-line with the fifth technique 118 to control the return.

The fifth technique 118, like all previously described techniques, is preferably It takes the form of a flexible tube or conduit made of a blood-compatible material. Fifth technique The means includes another phlebotomy needle 122 at its end.

Although individual phlebotomy needles 32 and 122 are shown in FIG. Means 28 and 118 are common to one double lumen needle (not shown) of conventional construction. It should be recognized that each person can communicate with others.

The system 12 shown in FIG. a third transfer container 124 for diverting blood from the donor to another for storage in the third transfer container 124; A transfer container 124 and a sixth technique 126 are optionally included. to container 124 Valve means 128 is in-line with sixth technique means 126 for controlling the transfer of red blood cells. Located at the Inn.

The system 12 shown in FIG. 3 also includes a sterile saline source 82 and associated branch conduits. In addition to stages 84 and 85, a sterile anticoagulant solution source 130 and branch conduit means 132 for introducing an anticoagulant solution into system 12. Controlled introduction of anticoagulants Valve means 134 is provided in-line with branch conduit means 132 for this purpose.

Pumping means 136, preferably in the form of a peristaltic pump, pumps the anticoagulant through the technique means 132. can be included to weigh the introduction of.

As in system 10 of FIG. 2, system 12 preferably operates throughout operation. and closed from communication with the atmosphere, thereby maximizing the allowable storage time.

To maintain the closed integrity of system 12 during continuous flow operation, all centrifuge vessels 26 and The first one that communicates. The second and fifth branch conduit means 28.42 and 118 are umbilical. 138. In Adams U.S. Reissue Patent No. 29.738 In accordance with the principles discussed, this umbilical cord 138 is preferably attached to the container 26 during centrifugation. It rotates at half the speed. This causes twisting of the umbilical cord 138. fluid communication through the umbilical cord 138 is continuous without the use of rotating seals. maintained.

System 12 is easy to use with equipment that uses rotary seal structures and the like. It should be readily recognized that it can be adapted to However, such a structure Compromise the closed sterile integrity of system 12 as determined by applicable U.S. standards. , which can therefore lead to significantly shortened storage times.

Also, unlike the system 10 shown in FIG. does not use pooling means 56 and instead directs blood from container 26 to porous membrane means 22. Plaque Lynch plasma is continuously transferred in response to actuation of pump means 24.

The system 12 shown in FIG. 3 can be configured in a variety of ways. Figure 7 shows a representative of system 12. A target assembly 140 is shown.

Similar to assemblies 8, 8 shown in FIG. the operator to form the system 12 using the connector means 94 Thus, two or more separate subassemblies (140a to 140a) that can be selectively connected (specified by g).

In addition, all or part of the subassemblies 140a to 140g are supported within the protective outer bag 90. can. system 10 and corresponding assembly 88, and system 12; Other common elements are given common reference numerals in FIG.

In the assembly shown in FIG. 7, the centrifuge container 26 is a cell rifuge It takes the form of a disposable ball 142 that fits into the centrifugation chamber of the micrometer. Configuration of ball 142 Specific details of the Bachehowski et al.'s "Rollable Processing Ball Device" National Patent Application No. 243.981 and “Jointing Shiso” filed on March 16, 1981. Rotatable for centrifugal processing devices with pre-coiled umbilical cord systems. A U.S. patent issued by Bacechowski et al. entitled Ball Assembly 5. Application No. 244,398. Please refer to the description of these applications. Incorporate.

As previously described in the environment of assembly 88, subassemblies 140a, etc. Two or more pieces of Ishig should be combined during manufacturing to reduce the total number of subassemblies. I can do it.

For example, subassemblies 140b, c and d (membrane means 22 and transfer vessel 74) and 78) may be constructed into an integral unit 144.

The remaining subassemblies 140e, f and g (saline and anticoagulant sources 82 and one or more of the subassemblies 140a (the used (disposable bowl 142 and associated tube).

Use of the system 12 and associated assembly 140 during - continuous flow operations , maximum tolerated amounts of substantially all therapeutic plasma-based components, and (optionally) red blood cells 1 Allow unit sampling. System 12 and assembly 140 are each preferably In a new specific example, it is a closed system as judged by the US standards, so it is not possible to collect it. All of the ingredients listed are suitable for storage for maximum permissible periods.

As previously explained, storage of ingredients depends on the physical properties of containers 74, 78 and 124. Further enhancements can be made by pre-selecting to benefit the intended storage function. can be done. A third transfer is carried out to mix the red blood cell storage solution S with the collected red blood cells. It can also be supported within the exchange container 124.

If an operator uses system 12 or assembly 140 to detect any red blood cells If no units are harvested, the harvesting operation can generally be repeated once every two weeks. if If red blood cells are collected, the procedure - whereby the whole blood contains approximately 200 red blood cells and about 250 volumes of platelet-rich plasma.

Next, 250 d of platelet-rich plasma was used, each fiber having an effective length of about 214 N and about 0.55 N. Contains approximately 800 polypropylene porous hollow fibers with a maximum pore size of microns 4 and 5. , lower than 50ml/g An inlet flow rate of 50 strokes/min at mouth pressure was maintained for 5 minutes.

Platelet-rich plasma thereby contains approximately 6.5×L O1G platelets. 50 bottles of platelet concentrate (which represents a concentration of 1.3 x 106 platelets per μl) ) and a concentration of approximately 120 platelets per μl (thereby resulting in a substantial platelet deficiency). About 200 plasma samples (constituting 100% of plasma) were isolated.

The table below summarizes the yields and times of the operations described in the examples and Compare with typical yields obtained by conventional non-automated patch centrifugation.

(Margin below) H6,1 international search report

Claims (1)

[Claims] 1. Collect the entire surface from the donor to separate mainly red blood cells and platelet-rich vasculature and receiving a platelet-rich blood scene from the first means of iii. and the platelet-rich blood is mainly platelet concentrate and substantially contains platelets. a second means for non-centrifugally separating blood components that are not present; Collection system. 2. The second means includes a procedure for collecting a predetermined volume of platelet a for storage. Blood component collection system according to Section 1, which is operated by Dan. 3. The second method is to use a predetermined volume of blood that is substantially free of platelets for storage. A blood component collection system according to paragraph 2, comprising means for collecting blood components. 4. The first means includes means for collecting a predetermined volume of red blood cells for storage. A blood component collection system according to item 2 or 3. 5. Each of the collection means is suitable for the intended storage function of each means. blood component collection according to paragraph 4, which includes means for imparting aesthetically pleasing physical properties; Tori system. 6. The physical properties imparted to the platelet collection means improve platelet survival. A blood component collection system according to clause 5, including improved gas permeation properties. 7. The above-mentioned physical patent application granted to the above-mentioned means for collecting a blood scene substantially free of platelets ( Contains a relatively high cold strength that facilitates the freezing of virtually platelet-free blood cells Blood component collection system according to Section 5. 8. The physical characteristics imparted to the red blood cell collection means prevent hemolysis of red blood cells during storage. A blood component collection system according to Section 5, which is suppression. 9. The first means includes means for returning red blood cells to the donor, Blood component collection system according to Section 2 or Section 3. 10. The first means diverts a predetermined volume of red blood cells to other parts of the blood donor for storage. The blood component collection system according to Paragraph 9Q, which includes means communicating with the return means for the purpose of Mu. 11 The sample blood cell distribution means has physical properties that suppress hemolysis of red blood cells during storage. 10. A blood component collection system according to clause 10, comprising a collection means according to claim 10. 12. The second means transports the platelet plasma from the first means to the second means. Clause 1 comprising conduit means integrally read into said first means for transfer to said first means. blood component collection system. 13. The second means includes the guide for passing platelets from the platelet-rich dish. A blood component according to part 12 comprising porous membrane means integrally connected to the tube means. Collection system. 14. said first and second means normally isolate said associated means from communication with the atmosphere; for sealing and connecting the connectors by bringing their respective parts into face-to-face contact. one connector each including a means, said facing portion containing a melting means; Only in response to exposure to a sufficient energy source to effectively sterilize said first or and the second means actuated to fuse to form a fluid passageway interconnecting the first and second means. A blood component collection system according to paragraph 1, comprising means for: 15. The i-th component is placed in a centrifugation chamber of an in vitro blood processing device to undergo centrifugation. Blood component collection system according to paragraph 1, comprising container means operative for placing . 16. The second means is a porous membrane that operates to pass cellular components from the blood. means for introducing a fluid into the porous membrane means for undergoing sparging; conduit means in communication with the membrane means and operative for connection with the pump means; Blood component collection system according to Section 1 or Section 15. 17. No. 1 suitable for use with an in vitro blood processing device having a centrifugation chamber. 1 part, the first part being arranged in a separation chamber of said apparatus for undergoing centrifugation. a centrifuge container suitable for placing the Whole blood is separated from the donor in response to centrifugal force in which it separates into first and second components. and a first branch conduit means for introducing the centrifuge vessel into the centrifuge vessel; porous membrane means operative to pass the blood component; and a porous membrane means operable to pass the blood component; said centrifugation for introduction into said porous membrane means for passage into said third and fourth components. a second means in communication with the container and operative for attachment to the pump means; a second part operative for attachment to the pump means; A blood component collection system equipped with 18. The second portion includes a first transfer container and a third component in the first transfer container. in communication with said porous membrane means and said first transfer vessel for transfer to a vessel. The blood component collection system according to clause 17, comprising a third technique. 19, said third component comprises plasma, and said first transfer container serves to cool the plasma for storage. Section 18 made of materials with relatively high low temperature strength to facilitate freezing. blood component collection system. 20. The first transfer container contains a blood component according to paragraph 19 comprising a polyolefin material. Collection system. 21. The second part includes a second transfer container and the fourth component is transferred to the second container. a second transfer vessel in communication with said porous membrane means and said second transfer vessel for transfer to said porous membrane means and said second transfer vessel; The blood component collection system according to paragraph 18, comprising the techniques of No. 4. 22, the fourth component comprises platelets, and the second transfer container comprises improved platelets; The second part is made of material with physical properties of improved gas permeability properties for survival. Blood component collection system according to Section 21. 23. The blood component collection system according to paragraph 22, wherein the material is a polyolefin material. Mu. 24. The material is a polyplasticized with tri-2-ethylhexyl trinoliftate. A blood component collection system according to Item 22, which is vinyl chloride. 25. The second component contains red blood cells, and the centrifugation container suppresses hemolysis of the red blood cells during storage. A blood component collection system according to paragraph 17 that is made of a material that has physical properties that control Tem. 26. The material is polyvinyl chloride plasticized with di-2-ethylhexyl phthalate. A blood component collection system according to Paragraph 25, which is a method for collecting blood components. 27. The first portion is in communication with the centrifuge container to deliver the second component to the donor. Collection of blood components according to paragraph 17, including the fifth technique operative to return system. 28, the first portion is configured to provide a third transfer container and a predetermined volume of the second component; said fifth technique and for diverting the flow into said third transfer vessel for transfer to a person other than said person; and a sixth technical means in communication with said third transfer container. Blood component collection system. 29. The second component contains red blood cells, and the third container prevents hemolysis of the red blood cells during storage. Blood component collection systems according to paragraph 28 that are made of materials that have physical properties that inhibit stem. 30. The material is polyvinyl chloride plasticized with di-2-ethylhexyl phthalate. A blood component collection system according to Paragraph 29, which is a method for collecting blood components. 31, the second component contains red blood cells, and the third transfer container contains a red blood cell nutrient solution; A blood component collection system according to paragraph 28, comprising: 32. According to paragraph 31, said solution contains saline, adenine and glucose. blood component collection system. 33. Blood component collection according to paragraph 32, wherein the solution further contains mannitol system. 34. Each of said means has a fluid passageway closed to communication with the atmosphere. a receptacle integrally connected to said system and its respective container to form a According to any of paragraphs 17 to 33, including the specified length of the flexible tube. Blood component collection system. 35. At least one of said technical means, each one of said technical means being in contact with the atmosphere. The normal is closed for dividing into two parts which are normally sealed from the communication first and second connector means, each of said connector means selectively connect the first and second connector means together by bringing some of the connectors into face-to-face contact with each other. including means for mechanically coupling said facing portions to effectively connect the fused portions of said facing portions. through said facing portion only in response to exposure to an energy source sufficient to sterilize the a first fluid passageway comprising means operative to fuse the fluid passageway to form the fluid passageway; A blood component collection system according to any one of Items 17 to 33. 36, the meltable portion of the facing portion is configured to hermetically seal the fluid passageway; blood according to paragraph 35, further operative to fuse the periphery of said fluid passageway during melting; Liquid component sampling system. 37. Each of the meltable means of the facing portion is made of a radiant energy absorbing material. and sufficient radiation sterilization to effectively sterilize said fusible means. Blood component collection system according to paragraph 36 that melts in response to exposure to a source of . 38, said fluid passageway formed through said connector one means to said system; A blood component collection system according to paragraph 35 that provides a probability of non-sterility of at least 10-6. Tem. 39, further comprising a source of sterile anticoagulant solution and a source of sterile saline, said conduit means A seventh branch for introducing an anticoagulant solution into the system. and an eighth technique for introducing saline into said system. A blood component collection system according to Section 17. 40. Separating a predetermined amount of whole blood into mainly red blood cells, platelets, and plasma; and Beauty Non-centrifugal separation of platelet-rich plasma into platelets and virtually platelet-free blood The process of; Blood component collection methods including. 41. The process of collecting platelets for storage, and blood crimes that do not substantially contain platelets. The method for collecting blood components according to Clause 40, further comprising the step of collecting. 42, according to paragraph 41, further comprising the step of collecting a predetermined volume of red blood cells for storage. Blood component collection method. 43. Blood component collection according to paragraph 41, further comprising the step of returning the red blood cells to the donor Method. 44, further comprising diverting the predetermined volume of red blood cells to other parts of the donor for storage. Blood component sampling method according to Section 43. 45. Each step is carried out in a manner that does not expose the blood to communication with the atmosphere. Blood component collection method using any of the 44th method. 46. The blood component collection method according to item 45, wherein the whole blood separation step includes centrifugation. 47. The non-centrifugation step involves passing platelet-rich plasma through a porous membrane. The method for collecting blood components according to paragraph 46, comprising: