JPS59501344A - Increased Yield Continuous Flow Blood Component Collection System - 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] Increased Yield Continuous Flow Blood Component Collection System Honkeisho■Bunkai This application relates generally to systems that enable the collection of whole blood and its separation into therapeutic components. and on methods. This application generally describes the maximum allowable duration of whole blood and its therapeutic components. The present invention also relates to whole blood collection and separation systems and methods that allow for storage. This application is It also relates generally to continuous flow in vitro blood processing systems and methods.

To 8 of 8H and, Instead of routinely providing whole blood infusions to patients, the consensus among the medical community is to Treatment is performed by providing only the therapeutic components of whole blood needed to treat the specific disease. This is something that can be improved. This treatment is commonly referred to as blood component therapy.

Due to the popularity of blood component therapy by the medical community, there is a constant demand for whole blood therapeutic components. It is increasing. Similarly, for collecting, separating, and storing therapeutic components of whole blood. The demand for safe and effective systems and methods has grown accordingly. ing.

For example, the use of human platelets to treat thrombocytopenia has increased dramatically over the past decade. Ta. Contains virtually all blood clotting components for the treatment of patients with diseased livers. The use of fresh frozen blood is also widespread. albumin, protein fraction, gamma mag There are a number of other hematopoietic fractions, such as lobulin, and AHF (clotting factor ■), All of them have specific recognized therapeutic purposes. Similarly, red blood cells Commonly used to treat sexual anemia.

One desirable feature for blood collection and separation systems and methods is to Clinically proven blood component yield requirements during blood collection operations are largely due to the fact that red blood from a customarily limited number of blood donors who provide blood and/or plasma-based components of whole blood. It is coming.

The importance of this feature also derives from the cyclical nature of blood sampling. For example in the US 1 unit of whole blood from an individual donor (approximately 45 Collection of 0d) should only be performed once every 8 weeks if red blood cells are held for storage. It can be done. If the red blood cells are returned to the donor and only the plasma-based component is left behind, (such as during plasma or platelet export), collection operations are often It can be repeated twice within 7 days. However, even then, the U.S. There are limits to the total plasma volume that can be collected from a donor during a single procedure.

Currently, the maximum permissible plasma volume (excluding anticoagulants) is 17 Approximately 720m for donors under 5 pounds! Q and those weighing 175 pounds or more For blood donors, it is 875 shuku.

The importance of this feature lies in the fact that certain ingredients are required to achieve the desired therapeutic effect. It also comes from relatively large doses of. For example, a single therapeutic dose of platelets is typically Typically, there are approximately 35 to 45 x 10" platelets, which are taken from one unit of whole blood. This is about 8 times the number of platelets that can be collected. In other words, one person who needs platelets The equivalent of 8 units of whole blood is required to meet the patient's needs.

A system that helps maximize component yield for each operation could serve therapeutic purposes. It can help offset these factors that collectively limit blood supply. can.

Very closely related but other methods for blood collection and separation systems and methods One of the desirable features of is the ability to use it in conjunction with continuous flow in vitro blood processing operations. It is the ability to In such operations, whole blood from the donor is separated by a separation system. through which some of the components are harvested (or harvested) and the remaining blood is returned to the donor. blood to the donor at any given moment during the operation. Liquid deprivation is thus minimized. As a result, a single unit hatching operation Significantly larger total volumes of whole blood than can be processed in a continuous flow masterpiece. child This results in higher yields of plasma-based fractions. For example, in a single unit honey collection operation, Approximately 5×10 0 platelets can be harvested in continuous flow operation, but in continuous flow operation Up to 60 x 1010 platelets can be collected. Advantages of using continuous flow systems The benefits are clear.

Other desirable features for blood collection and separation systems and methods include long-term storage. It is its ability to obtain ingredients suitable for brewing. This is also due to the limited supply of whole blood available. This feature helps offset the sterility that a given blood collection system can guarantee. It is closely related to the degree of sexuality.

For example, in the United States, non-sterile or is collected into an open system, and processed whole blood and components are collected 24 hours after collection. Blood transfusion must be given within a short period of time. On the other hand, in the United States, continuous Whole blood and red blood cells collected in a sterile or closed system, whether in a flow operation, can be stored for up to 35 days, depending on the type of anticoagulant and storage medium used. .

Similarly, in the United States, platelets collected in sterile or closed systems are subject to chaste storage conditions. Store for up to 5 days, and possibly longer, depending on the capacity of the storage container to maintain the condition. can do.

In the United States, federal regulations (CFR 21 Part 640.16 (b)) 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 blood sampling To maintain the system, the system must be accessed in a non-sterile manner after blood collection. I can't. According to American standards, the Entry into a blood collection container that provides a probability of non-sterility constitutes non-sterile entry.

Non-sterile entry opens a previously closed system and allows for collection to occur within the system. and record a significantly reduced shelf life of processed blood and components.

With the above considerations in mind, one of the main objects of the present invention is to The fractional components obtained during the harvesting operation in a manner that also guarantees the maximum allowable storage period of Provides a blood component collection system and method that maximizes minute yield to the maximum extent possible. It is to be.

Another main objective of the invention is that it can be used in a continuous flow operation environment. An object of the present invention is to provide a blood component collection system as described just above.

In addition to the foregoing considerations, other desirable features of blood collection and separation systems and methods is a compact device that can be efficiently manufactured, stored and utilized by operators. The goal is to create a system that can be easily handled.

With this in mind, another of the main objectives of the present invention is to provide a compact and easily Any of the subsystems or entire system that can be handled and formed two or more that can be combined sequentially without compromising the sterile integrity of the initially presented a blood component collection system formed from separate, closed subsystems. It is to provide.

Za prisoner ■ To λ already required - To achieve these and other objectives, the present invention provides during continuous flow in vitro blood collection operations in a manner that also guarantees the maximum allowable storage period for Increased yield blood component collection system that maximizes the yield of blood components obtained to the greatest extent possible. Provide the stem.

Systems embodying features of the present invention each include a centrifugal component of an in vitro blood separation device. It includes first and second centrifuge containers suitable for mounting within the isolation chamber. The system is Some of the components separated in the centrifuge container may be collected therein for storage. further comprising first and second transfer containers that can be moved.

The system is also closed from communication with the atmosphere and including conduit means for establishing a plurality of fluid passageways interconnecting the parts of the .

More particularly, the conduit means includes first and second components (e.g. red blood cells and platelet cells). for introducing whole blood from the patient into a first centrifugation vessel for separation into centrifugal blood samples; including an operative first technique. The conduit transports a first component (e.g. red blood cells) to a first A second technique is included that is operative to return blood from the heart container to the donor.

The conduit means has a third clamping means in communication with the first centrifuge container and the second centrifuge container. Including further. The second component (e.g., platelet-rich plasma) passes through the third clamping means to the second component. Transferred to No. 2 centrifuge container. Therefore, the second component is further combined with the third and fourth components. For example, it is separated into platelets and platelet-poor plasma).

The conduit means has a fourth clamp means in communication with the second centrifuge container and the first transfer container. Contains more. The fourth clamping means transfers the third component (e.g. platelets) to the first transfer volume. It operates to transfer to a container. A fourth component (e.g., platelet-poor plasma) is transferred to the second transfer. The fifth clamping means connects the second centrifuge container and the second transfer container for transfer into the transfer container. Communicate with.

a sixth clamp for diverting the fourth component from the second transfer container for return to the donor; Tiers are also provided.

In one embodiment, the system includes a third transfer vessel. In this configuration , said conduit means transporting a first component (e.g. red blood cells) from the patient and into a third transfer volume. a seventh clamp in communication with the second clamp and the third transfer vessel for diverting the flow into the vessel; including.

- In embodiments, the system also includes a source of sterile anticoagulant solution and a source of sterile saline. including. In this embodiment, said conduit means directs these sterile solutions into the system. Includes additional clamping means for inserting.

This system can accommodate up to approximately 60 x 1010 platelets during one continuous flow operation. (suspended in about 200 d of plasma), platelet-poor plasma up to about 500 dead, and (in some cases) allows the collection of packed red blood cells of up to about 250 relatives. give The total volume that can be collected by this system during a given operation is dependent on the physiological state of the donor. and the maximum allowable volume allowed by the governing regulations. .

Once sterilized, the system is a closed system, so all collected components are Suitable for high tolerance storage periods.

- To further enhance the storage of the components collected in the specific example, each transfer container is have predetermined physical properties that favor long-term storage of blood components transferred into given.

For example, the transfer container containing platelets is preferably certified for platelet viability. It has physical properties of improved gas handling properties which have other beneficial effects. Similarly, The transfer container containing the platelet-poor plasma preferably contains blood 5i for a long storage period. are made of materials with relatively high low temperature strength to facilitate freezing. similar In addition, the transfer container containing the red blood cells preferably has a structure that inhibits hemolysis of open blood cells in long-term storage. Made from materials known to be effective. Instead, this container has the same effect. Contains red blood cell storage and nutrient solution known to achieve.

In one embodiment of this system, all or part of the container associated with the system without compromising the sterile integrity of any of the containers or the entire system formed. includes physically separate entities that can selectively coalesce to form systems. nothing.

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

N blood station FIG. 1 depicts the functionality of an increased yield blood component collection system embodying various features of the present invention. FIG.

Figure 2 shows a continuous flow in vitro blood treatment system that can be combined with the collection system of Figure 1. FIG. 2 is a perspective view with a part of the control device cut away and a part thereof shown in cross section.

FIG. 3 shows the increased yield blood product shown in FIG. 1 in combination with the processing device shown in FIG. FIG. 2 is a plan view of a specific example of a fraction collection system.

Figure 4 provides a functional overview of some of the other specific examples of the increased yield collection system shown in Figure 1. FIG. 3 is a schematic plan view.

FIG. 5 is an enlarged view of a portion of the increased yield harvesting system shown in FIG.

FIG. 6 shows one means of connectors associated with systems in a non-coupled relationship; FIG. FIG. 2 is an enlarged partially broken, partially cutaway cross-sectional view of a part of the system shown in FIG.

FIG. One means of the connector shown in FIG. 6 being exposed to the energy-induced melting apparatus. FIG.

FIG. 8 shows one means of the connector shown in FIG. 7 after a fluid passageway has been opened therethrough. FIG.

Before describing specific examples of the present invention in detail, the present invention will be described below in its application. The details of the construction and arrangement of the components described herein or illustrated in the accompanying drawings are limited to It should be understood that this is not specified.

The invention is capable of other embodiments and of being practiced in various ways. Also adopted here It should be understood that the words and phrases used are for descriptive purposes only and should not be considered limiting. be.

Moro of the late day l An increased yield blood component collection system 10 is shown in FIG. The system has both An in vitro blood processing device having a centrifugation chamber 14, both schematically shown in FIG. It is specifically designed for use in conjunction with the device 12.

The system 10 includes first and second containers 20 and 22, respectively. container 2 0 and 20 are each made of a material suitable to withstand high speed centrifugation. Each content The vessels 20 and 22 are therefore suitable for mounting within the separation chamber 14 of the device 12. .

To leave some blood components for storage, System 1.0 has two and Three transfer vessels contain 26.28 and 30, respectively.

To establish fluid communication between the various elements of system 10, system 10 includes conduit ports. It includes a stage 34. Conduit means 34 establishes a plurality of fluid passageways, each of which is connected to the atmosphere. It is closed from communication with. For this reason, system 10 cannot be applied once sterilized. Obtain a closed system measured according to American standards.

More particularly, and still referring to FIG. 1, conduit means 36 is connected to the first centrifugal volume. It includes a first clamping means 36 communicating at one end with the vessel 20. Clamping means 3 of body 1 6 communicates with a phlebotomy needle 16 at its other end. For this reason, the first clamping means 36 It serves to introduce whole blood aspirated from the donor 18 into the first centrifuge container 20 .

Whole blood introduced into container 20 is placed into a centrifugal force field generated within chamber 14. even later As described above, the first and second components of whole blood are separated due to the difference in density, Different zones radially spaced from the axis of rotation of chamber 14 are clustered within the container.

The conduit means 36 further includes a second clamping means 38 communicating at one end with the first centrifuge container. Included in The second clamping means 38 communicates with another phlebotomy needle 32 at its other end. Ru. The second clamping means donates a selected one of the components separated within the first container 20. work to give back to the people.

Each phlebotomy needle 16 and 32 is integrally connected with an associated branch conduit means 36 and 38. A conventional needle cover or sheath (not shown) is provided and removed during venipuncture. ) can be normally sealed from communication with the atmosphere.

Instead, each branch conduit means 36 and 38 is connected to a conventional needle adapter (Design, Illinois). Trahenol, part of Laborfield Laboratories, Inc. FenWall is a leading manufacturer of blood container sensors sold by Laboratories. (such as in preparation for the start). The needle adapter attaches to the needle before venipuncture. Accommodates 16 and 32.

Although individual needles 16 and 32 are shown in FIG. Stages 36 and 38 each communicate with a single multi-lumen needle (not shown) of conventional construction. I can do it.

Conduit means 34 also extends between the first centrifuge vessel 20 and the second centrifuge vessel 22. It includes a third technique means 40. The third technique 40 removes the remaining material from the first centrifuge container 20. serves to transfer the separated components contained therein to the second centrifuge vessel 22. This second In the container 22, this component is further separated into a third component and a fourth component as a result of centrifugation. separated into

Conduit means 34 includes a fourth conduit extending between second centrifuge vessel 22 and first transfer vessel 26. It includes a technical means 42. The fourth technique means 42 transfers the liquid from the second centrifuge vessel 22 to the third centrifuge vessel 22. It serves to transfer the components to the first transfer vessel 26.

Similarly, a fifth technique 44 is also located between the second centrifuge container 22 and the second transfer container 26. provided. The fifth technique 44 transfers the fourth component from the second centrifuge container 22 to the second transfer. It works to make a confession into the exchange container 28.

The conduit means 4 may also include a sixth conduit extending between the second technical means 44 and the second technical means 38. It includes a technical means 46. The sixth technical means is the third technical means carried by the fourth technical means. A second transfer container 2 for returning all or part of the components of 4 to the donor at a desired time. Works to divert the flow from 8.

System 10 can optionally include a third transfer vessel 30. This configuration In , the conduit means extends between the second technique means 38 and the third transfer vessel. means 48; The seventh technical means 48 is the first technical means carried by the second technical means 38. from the donor to the third transfer container 30 if it is desired to retain this component. Works to divert water to the inside.

In the illustrated preferred embodiment, system 10 also includes a source of sterile anticoagulant solution. 50 and a source of sterile saline 52.

In this configuration, the conduit means 34 prevents the donor's blood from coagulating during the operation. The eighth technique 54 operates to introduce an anticoagulant solution into the system in order to Contains.

In this configuration, the conduit means are connected to the channels designated 56a and 56b in FIG. 9, which further includes expelling air from the system 10 prior to operation; After the operation, saline solution is introduced into system 10 to wash the components from system 1o. Work for (.

In the particularly preferred embodiment shown in FIG. 1, the saline solution is in communication with the technique 36 of FIG. It enters the system through a leading branch conduit means 56a.

The saline solution passes through a branch conduit means 56b communicating with the second technical means 38 to the saline source 52. Returned or ejected.

In an alternative configuration (not shown), the return branch conduit means 56 can be omitted and the The priming volume of saline can then be expelled directly through the phlebotomy needle 32. Wear.

In other alternative configurations, the return branch conduit means 56b may be omitted and the saline collection The collection container 53 (indicated by dotted lines in FIG. 1) is connected to the auxiliary branch conduit means 57 (also (indicated by dotted lines in the figure) can communicate with a second technical means 38. saline solution The briming volume of is thus collected in the container 53.

Valves to control and direct the flow of whole blood and its components within the system Means 58 is the first. Second. Third. 4th. Fifth. 6th゜7th. 8th. 9th and (- in alternative embodiments) assistive technology means, 36.38.42, 44, 46.4 respectively. 8, 54, 56a, and b, and inline with 57. valve hand Stage 58 can be configured in a variety of ways. For example, the valve means 58 may be a roller clamp. This can take the form of a manually operable clamping mechanism such as a hemostat or hemostatic forceps. Ru. Alternatively, all or a portion of the valve means 58 may be a control circuit of the processing device 12. It can be an electrically actuated valve interconnected with the duct.

The system 10 described so far collects the maximum allowable volume of up to three therapeutic components. be able to. Additionally and significantly, the system 10 as a whole is a post-sterilization closed system ( Each of the components sampled constitutes (as determined by applicable U.S. standards) The maximum allowable storage time is obtained for

To further enhance storage of components harvested by system 10, each transfer vessel 2 6. At least a portion of 28 and 30 is intended for containers 26° 28 and 30. Predetermined physical characteristics are provided that are advantageous for reservoir function. This point will be discussed later. will be described in more detail.

In order to efficiently use the system 10 for its intended increased yield purposes, the processing device 1 2 through system 10 without compromising the closed sterile integrity of system 10. It is capable of processing a continuous flow of blood. An example of such a device is the Cullis et al. U.S. Pat. Nos. 4.146°172 and 4,185,629 seen in A commercially available system that is particularly well suited for use in An example of such equipment is manufactured and sold by Fenwall Laboratories. It is a C5-3000 blood cell separator. This particular processing device 12 is generally shown in FIG. It is shown.

The system 10 shown in FIG. 3 has a close operational interface with the device 12 shown in FIG. DeVries' now-abandoned U.S. patent application 8 43,223 (filed on October 18, 1977), monitor and and DeVries' pending U.S. Patent Application No. 100 entitled Fluid Circuit Assembly. , 975 (filed December 6, 1979); It is.

In the system 10 shown in FIG. 3, the conduit means 34 is preferably a plasticized polysalt It takes the form of a plurality of flexible branch conduits made of vinyl chloride material. These conduits are shown in Figure 1. will be identified by the same reference numerals as the corresponding branch conduit means in the section.

As best shown in FIG. 3, the branches of conduit means 34 are arranged in a compact housing. 60. Some branches of the conduit means 34 are arranged in sections of the housing 60. support within the painting, 'while arching selected ones of these branches outward from one of the side walls 64. bend in any direction, and - for example, stand upright and freely at a generally right angle to the wall 64. a predetermined loop or arc that is biased elastically towards a position Means 62 for shape support are provided on the side wall 64 of the housing 60.

As seen in FIGS. 2 and 3, this looped shape connects system 10 to the desired tightness between the peristaltic pump rotors 66 and 68 attached to the processing device 12; enables a close operational interface.

Also in this configuration, the housing 60 monitors the flow of components through the system. an operative interface with an associated sensing mechanism on the processing unit 12 to Various monitoring devices 76, 78, 90, 92 and 96 (see especially Figure 3) yo).

Furthermore, in the configuration shown, conduit means 3 communicating with centrifuge vessels 20 and 22 4 is connected to the umbilical cord 70. Adams Reissue U.S. Patent 29 , 738, this umbilical cord 70 connects vessels 20 and 22. Rotates at half speed. Parts of system 10 located inside and outside chamber 14 This avoids the twisting of the umbilical cord 70 in minutes and allows the umbilical cord 70 to pass through. Continuous fluid communication is maintained without the use of rotating seals. System IO sterility The closed integrity of is not compromised because of this.

System 10 has a rotary seal structure or its equivalent that ensures the sterile integrity of system 10. Easily adapted for use with equipment that uses rotary seal structures or other You should be aware that you can

Reference will now be made to the specific configuration of the conduit means 34 in the embodiment shown in FIGS. 2 and 3. illuminate

First branch conduit 36 includes an adapter 17 that operably connects with entry phlebotomy needle 16. nothing. Conduit 36 passes into and through the housing, and from there the umbilical cord 70 extends through. Conduit 36 passes through an in-line air trap 74 to a first centrifugal volume. It is integrally connected to the inlet boat 72 on the vessel 20.

Portion 37 of the first branch conduit is attached to the free-standing looped configuration previously described. Extends to the outside of the housing 60. This corresponds to the pump 66 supported by the device 12. allows the desired operational interface with the computer. The operation of this pump 66 is due to blood donation. Whole blood aspirated from a person is introduced into the first centrifugation container 20.

As seen in FIG. 3, within the housing 60 the first branch conduit 36 It passes through a pulse sensor 76. This sensor 76 detects collapsed veins, blood clots, and in the blood stream from the donor, such as occurs as a result of a kink in the conduit 36. Detect interruptions or limitations.

Within the housing 60, the first branch conduit 36 also has a blocked line sensor. Pass 78. This sensor 78 may be detected by a bend or air in the conduit 36. Detect blockages that occur.

Both sensors 76 and 78 sound an alarm if an undesirable condition occurs. A sensing circuit (not shown) supported by device 12 to shut off device 12 ).

First centrifuge vessel 20 includes a first outlet port 80 at its center. This port plate 80 of the donor's whole blood during centrifugation of the first container 2o in the chamber 14. It communicates with Zone 82, where lynchings are likely to gather.

Container 20 also includes diametrically spaced second and third outlet ports 84 and 86. Contains. These ports 84 and 86 are ports where donor red blood cells collect during centrifugation. It communicates with the ring 88.

The second branch conduit 38 connects the second and third outlet ports 84 and 86 of the first vessel. are integrally connected to each other. A second branch conduit 38 passes through the umbilical cord 70 and into and through the needle 60 and thence to the return phlebotomy needle 32 .

Similar to the first branch conduit 36, the second branch conduit 38 is connected to the adapter 3 which accommodates the needle 32. Contains 3.

As seen in FIG. 3, within the housing 60, the second branch conduit 38 is connected to a return tube. It passes through an insensor 90 and a foam trap 92.

Return line sensor 90 senses both positive pressure and depressurization alarm conditions. high positive pressure indicates a blockage in branch conduit 38 or needle 32. Depressurization indicates a leak.

Foam trap 92 senses the presence of air bubbles.

Both return line sensor 90 and foam trap 92 detect undesirable conditions. The device 12 is configured to sound a W alarm and shut off the device 12 if an emergency occurs. and a sensing circuit (not shown) supported by the sensor.

The second branch conduit 38 thus transfers red blood cells from the zone 88 of the first container 20 to the donor. Worked to carry it back to (.

The third branch conduit 40 is integrally connected to the first outlet port 80 of the first centrifuge vessel 20. be done. The conduit 40 passes through the umbilical cord 70 and passes through it into the housing 60 and there. The umbilical cord 70 then extends back through the umbilical cord 70 to the inlet boat 94 of the second centrifuge vessel 22. .

Portion 41 of third branch conduit 40 has the previously described looped free standing configuration. Extended ink. This portion 41 is located approximately from the looped portion 37 of the first branch conduit 36. A certain distance away. The looped section 41 of the third branch conduit is therefore It fits over only the pump 68 supported by 41.

The third branch conduit thus passes from zone 82 in first container 20 to platelet-rich blood. into the second container 22 in response to actuation of the pump 68.

Within housing 60, third branch conduit 40 passes through interface detector 96. inspection Output device 96 senses red blood cells within third branch conduit 40 .

If red blood cells appear, this is a combination of red blood cells and platelets in the first container 20. indicates that the interface between the two (see Figure 3) has been reached. This is platelet lynch blood All of the images indicate that container 20 has been removed.

As shown in FIG. 3, during centrifugation of the second centrifuge container 22 in the chamber 14, Platelet lynch The platelets supported in the blood 5jt are separated and placed in the bottom area of the container 22. They gather in Zone 98 inside. The remaining component, called plasma plate poor or fresh plasma, is It collects in zone 100 in the area above container 22. Port 102 is the second collection container It communicates with zone 100 above 22.

In this configuration, the fourth branch conduit 42 is aligned with the bow 102 of the second centrifuge vessel 22. connected to the body. Conduit 102 passes through umbilical cord 70 and onto first transfer vessel 26. to an inlet port 104 to which conduit 42 is integrally connected.

A fifth branch conduit 44 extends from the outlet port 102 of the second container 22 and from the umbilical cord 70. It extends in common with the fourth branch conduit 42 through the fourth branch conduit 42 . For this reason, a common extension of the conduit The section is identified in FIG. 3 by the numerals 42/42. The fifth branch conduit 44 is branched from the fourth branch conduit 42 and aligned with the inlet boat 106 on the second transfer vessel 28. connected to the body.

Because of this configuration, the desired volume can be transferred through the fifth branch conduit 44 into the second transfer vessel 28. After the platelet pool has been transferred, the remaining platelets (Hl into plasma) are subjected to a second centrifugation. Transfer from container 22 through fourth branch conduit 42 into first transfer container 26 is possible. can.

The sixth branch conduit 46 merges with the fifth branch conduit 44. The sixth branch conduit 46 is into the housing 60 where it connects the return line sensor 90 and and upstream of the foam trap 92 it merges with the second branch conduit 38 previously described.

The sixth branch conduit therefore transfers the platelet-poor plasma collection to the second transfer vessel 28 at the desired time. from the return phlebotomy needle 32 through the return line sensor 90 and foam trap 92. It plays a role of diverting the flow. During return to the donor, the platelet-poor plasma passes through the second branch conduit 3 8 will mix with the red blood cells flowing through it.

The anticoagulant solution source 50 is in a bag 108 made of plasticized polyvinyl chloride material or the like. , the hang containing a sterile anticoagulant. A suitable jacket 110 covers the bag during storage. is provided to prevent solution from evaporating from the pipe 108.

The eighth branch conduit 54 is integrally connected to the hang 108 and passes through the drip chamber 112. ) through the housing 60 and connects with the entry phlebotomy needle 17 .

As best seen in FIG. concentrically with the loop portion 37 of the first branch conduit 36 for co-actuating interface. looped.

By changing the inner diameter of the eighth branch conduit section relative to the inner diameter of the first branch conduit section 37. The desired fluid flow ratio can be achieved.

Sterile saline source 52 similarly includes a hang 114 with a suitable overcoat 116. 9th Branch conduits 56a and 56b are connected together through hang 114. 9th branch conduit The outlet portion 56a of the conduit is connected upstream of the occluded vein sensor 76 via the drip chamber 118. 36 and thereby communicate with the entry phlebotomy needle 16.

Return portion 56b passes through drip chamber 120 and merges with foam trap 92.

As previously explained, saline enters system 10 through section 56a and It is returned or discharged through section 56b.

Encased anticoagulant and saline bags 108 and 114 and their attached branches The integral connection with the conduit can be made in various ways. In the illustrated example, 198 U.S. Patent Application No. 282.8 of Boggs et al., filed on July 13, 1999. A boat block 122 such as that described in 94 is used.

The seventh branch conduit 48 connects to port 107 of the third transfer vessel 30 and to the return venous cut. Upstream of the open needle 33, it is integrally connected to a second branch conduit 38.

1st. Second. 4th. Fifth. 6th. 8th and 9th branch conduits (36, 38 respectively) , 42.44, 46, 54.56a and 56b) The cloth is attached to a motor-driven clamp 1 attached to and controlled by the device 12. 24 in turn according to the desired separation operation. Additional external manual operations A roller clamp 126 is provided in the position shown in FIG. alternative structure In the construction, the roller clamp 126 is connected to the entire motor-driven clamp 124 or can be partially replaced.

Adjustment of the clamps establishes the desired fluid flow pattern through system 10. You can see that.

More specifically, the system 10 shown in FIG. Once properly primed, the operator removes the blood from the donor (first branch conduit 36 Ensure the fluid flow pattern to collect whole blood into the first centrifuge container 20 (through the can stand. During centrifugation of container 20, platelet-rich plasma is in the first centrifugation container. Separate from red blood cells at . Platelet-rich plasma from zone 82 (third branch) tube 40) into the second centrifuge vessel 22. At the same time, The fluid flow pattern is such that red blood cells in zone 88 pass through second branch conduit 38 to the donor. allow it to be returned.

Collecting platelets in the bottom zone 98 of the second centrifuge vessel 22 as centrifugation continues. Can be done. Platelet poor blood cells collect in the upper zone 100, and in the fourth zone. 6th and and second branch conduits 42, through the fluid passageway collectively established by 46 and 38. can be returned to the donor.

When the desired concentration of platelets has collected in the bottom zone 98 of the second container 22 (approximately 200 plasma platelets in mJ2 (approximately 30 x 1010 to 60 x 1010), the operator Up to the maximum allowable volume of platelet-poor plasma in the second transfer container 28 (i.e. If 100 to 200 d of platelet concentrate volumetrically is collected, 500 m) should be collected. The fluid flow pattern can be changed to

If desired, the fluid flow pattern may be such that approximately 200 to 250 red blood cells are present at this time. adapted to divert flow into the third transfer vessel 30 through the seventh branch conduit 48 be able to.

The total volume of components that can be collected into system 10 during a given operation is dependent on the physiological state of the individual and the maximum allowable total volume allowed by the governing regulations. will.

After the platelet-poor plasma is collected into the second transfer container 28, it remains in the second centrifuge container. The platelet agglomerates containing the platelets are then manually pushed into the first transfer container 26 or Can be pumped separately.

In order to withstand the centrifugal force generated within the chamber 14, the first and second centrifugal vessels 2 are 0 and 22 are preferably made of a textured plasticized polyhinyl chloride material.

Platelet concentrate is transferred into it during operation to maximize the allowable storage time available. The first transfer vessel 26 is preferably gas permeable, which is advantageous for long-term platelet storage. Shake the characteristics. More specifically, the first transfer vessel 26 is preferably -Upgrades that of polyvinyl chloride plasticized with 2-ethylhexyl (DEHP) It will have gas permeability properties.

For example, the first transfer vessel 26 is described in U.S. Pat. 40.162 or Warner trimellitic acid tree as described in U.S. Pat. No. 4,280,497 of et al. Contains polyvinyl chloride containers plasticized with 2-ethylhexyl (TEHTM). I can do it.

Alternatively or additionally, the second transfer container 28 maintains platelet survival during storage. A platelet storage medium suitable for holding the platelets may be included.

Similarly, the second transfer container 28 into which the platelet poor bloodstream is transferred during operation is preferably Preferably, a material with relatively high low-temperature strength that can withstand freezing of platelet-poor blood cells during storage. It is made with.

Candidate materials for this purpose are the primary low density polyethylene and polypropylene species, such as copolymers of polyethylene and polypropylene, including those containing Contains various polyolefin materials.

To enhance the storage of red blood cells that can be collected into the third transfer container 30, the third The transfer vessel 30 is preferably made of DEHP plasticized polyvinyl chloride. Constructed from materials known to inhibit hemolysis of saline during storage.

Alternatively, or in addition, the transfer container 30 may be used to inhibit hemolysis during storage. A suitable isotonic red blood cell preservation solution may be included.

Such solutions are described in Grode et al., US Pat. No. 4,267,269. Ma Gro, filed May 11, 1982, entitled Red Blood Cell Preservation Solution and Method The 'Ig solution described in the U.S. patent application of r3eet at. Ingredients such as nin, mannitol and glucose may be included.

Use of system 10 allows the production of virtually all therapeutic plasma systems during one continuous flow operation. A maximum allowable amount of minutes and (optionally) collection of one unit of red blood cells is allowed.

Since System 10 is a closed system as determined by American standards, all sampled All ingredients are suitable for storage for a maximum permitted period of 7 hours.

If the operator collects any units of red blood cells. If not, the above operation is normal Can be repeated twice a week. If red blood cells are collected, this procedure is generally performed every 8 weeks. Can be repeated once.

Next, attention will be paid to the blood sampling system 11 shown in FIG. This system 11 is the third It shares many of the same features associated with the systems shown in the figure. There is a third common element Reference numbers are given as in the figure.

Similar to system 10 shown in FIG. 3, system 11 includes first and second centrifugal volumes. vessels 20 and 22, and the first. Second and third transfer vessels 26.28 and 3 Contains 0. As in system 10, containers 26, 28 and 30 All or part of them are endowed with advantageous properties for their storage function.

Conduit means 34 connects system 11 in a manner that closes system 11 from communication with the atmosphere. serves to interconnect the various elements of the

Similar to system 10, system 11 has a close working unit with device 12 shown in FIG. interface.

However, containers 26, 28, 30, 108, and 114 all Unlike the system 10 shown in FIG. 3, which is integrally connected to the transfer vessels 26, 28 and 30 and saline and anticoagulant vessels 108 and All or a desired portion of 114 is typically physically separate from the remainder of system 11. Real objects can be constructed.

In this configuration, physically separate containers 26, 28, 30, 108 and and 114 include a tear protective jacket 127 which is preferably removed during use. child The outer jacket also prevents the evaporation of fluids in the saline and anticoagulant containers 108 and 114 during storage. Preferably prevents development.

In this configuration, system 11 is typically connected to each system 11 in separate containers. the rest of the container without compromising the sterile, closed integrity of the entire container or system. means 128 for selectively establishing a fluid passageway in a different manner.

More particularly, the means 128 connect the normally closed first and second connectors. One means 130 is included. The first connector means 130 is usually a separate container 2 6, 28, 30, 108 and 114, and are torn apart before use. It is supported within the contour of the cover 127. A second connector means a corresponding branch conduit. 42°44.48.54.56a and 56b, respectively. Ru.

As seen in FIGS. 5-8, each connector means 130 and 132 , the first and second connector means 13 such that their respective portions 136 are in face-to-face contact. means 134 for selectively mechanically coupling the associated pairs of 0 and 132; I'm reading. The facing portion 136 carries a mated pair of connector means 130 and 132. forming a fluid passageway therethrough, thereby providing fluid communication between the container and the associated branch conduit; melts open, but effectively sterilizes the means 138 as they melt. Means 1 actuated only in response to exposure to an energy source that is itself efficient to Contains 38. This constitutes an active sterilization process that occurs simultaneously with the formation of the fluid path. to be accomplished.

Additionally, during the melting operation, the means 138 preferably provides a sealing seal 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 130 and 132 can be configured in various ways and have various actuation means. Can be adopted. However, in order to meet the desired yield increase objectives of System 11, , connector means 130 and 131 each must meet several operational requirements. Must be.

More specifically, each connector means 130 and 132 includes: (1) system 11; (2) when the fluid passageway is formed; It is only opened in conjunction with an active sterilization process that serves to sterilize the area adjacent to the aisle. , and (3) must be capable of hermetically sealing the fluid passageway when it is formed. .

U.S. Patents 4,157,723 and 4,265 to Granzow et al. , 280, that the sterile connectors generally meet all of the above criteria. has been determined and for that reason such a connector is shown in the illustrated example. ing.

The construction and operation of such a connector is best seen in Figures 5-8. . More particularly, each connector means 130 and 132 is connected to that of system 10. The housing 140 includes a hollow interior 142 in communication with portions associated with the housing. Ko The previously described connector attached to the facing portion 136 of the connector means 130 and 132 The fusible means 138 take the form of fusible wall means, each of which has an associated internal 142 is typically sealed or closed from communication with the atmosphere.

The housing 140 further communicates with an interior 142 and has a first connector means 1 30 to the end of the tube 146 integrally connected to the associated container and to the second connector. A tubular conduit serving to interconnect the terminal means 132 to the end of the associated branch conduit. It includes a tube section 144.

Connector means 130 and 132 are variously connected to the ends of tube 146 or branch conduits. In the illustrated embodiment, the tubular conduit portion 14 A hermetic friction fit between the 4 parts can be seen.

A resilient hand 147, such as made from a latex material, is attached to the tubular portion 14. 4 and the respective tube 146 or branch conduit. The outer periphery of the joint is preferably surrounded in order to achieve this.

In this configuration, the connector typically prevents fluid flow communication with the interior 142 of the means 130. An in-line valve member (shown in dotted line in Figure 5) may be provided to . Such a configuration includes fluid-filled anticoagulant and saline containers 108 and 11. Particularly desirable in combination with 4.

Valve member 148 can 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 148, such as that disclosed.

Instead, the rupture valve member 148 is manufactured by Granzow et al. 4, 265, 280, the connector housing 14 can form an integral part of 0.

In the illustrated embodiment, wall means 138 is molded from a radiant energy absorbing material. . It is therefore activated to melt in response to exposure to a radiant energy source. . Additionally, the material from which wall means 138 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. They are deliberately selected to melt. through the housing 140. Housing 1 to allow transmission of radiant energy to fusible wall means 138 40 is made of a material that does not absorb the particular type of radiant energy selected.

In a preferred embodiment, the wall means 138 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. U.S. Pat. No. 4,325,417 describes Tessarani theory. The material of the wall means 138 is It is colored black to absorb infrared rays. Housing 140 allows infrared radiation to pass through are made of transparent TPX material, which is generally transparent.

As best seen in FIG. 5, the connection means 134 is a mating bayonet type connection. , which brings their radiant energy absorbing wall means 138 into face-to-face contact (seventh (see figure) to interlock connector means 130 and 132 together. It acts like this. In the illustrated embodiment, the light is concentrated onto the opaque light absorbing partition means 138. When exposed to a light-induced melting device 150 consisting of an incandescent crystal lamp 151 set in a The radiant energy absorbing wall means 138 melts and fuses as seen in FIG. do. During the melting process, wall means 138 connects connector means 130 and 132. to establish a fluid passageway that is immediately sterile and closed to communication with the atmosphere. , forming a closed and sealed opening 152 .

As the following examples demonstrate, one of the illustrated connector means 130 and 132 Use ensures the establishment of non-sterility in excess of 1o-6.

Example Bacillus 5ubtilis var’ with 1.5xl OJ per ounce A methanol suspension of S. niger (globiguii) spores was prepared. The microorganism was chosen because of its high dry heat resistance (Angelotti et al. ,.

” Influence of 5pore Master Content on the Dry Heat Re5ist-ance of Baci llus 5ubtilis var niger”, Appl, Micro biol, Vol. 116 (51:735-745.1968).

80 connector means 130 and 132 shown in FIGS. 5 to 8. B, 5ubtil for one unconnected sterile connector part (i.e. 40 pairs) is var niger (globiguii) Q, 0.01 d of turbid liquid Inoculated. This covers the attached wall means 138 of each connector member 130 and 132. This resulted in exposure to approximately 1 million (or 106) microbial spores.

Each of the 40 inoculated unlinked connectors was attached to an empty sterile container. . The other 40 were each sterilized microbial growth medium (soybean casein digested (SCD) (Ross) was attached to the container containing the material.

These inoculated pairs of connector parts are hereafter referred to as test connectors. were inoculated only. Eight of these connectors are attached to empty sterile containers, and the other eight The cells were attached to a sterile container containing SCD broth. Connect these to the negative control. I'll call it Tar.

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 membranes and opens fluid passages. For this purpose, it was placed in the light-induced melting device 90 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 groove or 106 B, 5ubtilis va Inoculated with a theoretical challenge of R. niger (globiguii) spores, two The theoretical challenge of 104 spores per connecting groove was inoculated, and two were inoculated with 102 spores per connecting groove. Inoculate the theoretical challenge of spores, 2 connect grooves or inoculate the theoretical challenge of 101 spores did. Media was flowed through the fluid passages of these positive control connectors.

All units were incubated at approximately 32-37°C for up to 7 days. . After incubation, all suspension broths were re-incubated on SCD agar for approximately 30 min. and 37°C for 18 to 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 40 test connections.

All eight negative controls remained negative during incubation.

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

The system 11 shown in FIG. 4 is easily fabricated, packaged, sterilized, and shipped. It includes a series of initially separate subassemblies that are assembled and stored. so The prepared system 11 allows operators to customize the system to suit the collection purpose of a specific operation. To provide flexibility in conveniently tailoring the shape of a stem 11. These meaningful benefits are This is accomplished without substantial establishment of non-sterility of the system.

Systems 10 and 11 embodying features of the invention provide the highest yield and Allow the maximum allowable storage time for the components taken.

The invention is set forth in the various claims.

Claims (1)

[Claims]: Increased yield suitable for use with an in vitro blood processing device having a centrifugation chamber. a volumetric blood component collection system, wherein the separation chamber of the processing device is configured to undergo centrifugation; first and second centrifuge vessels disposed within the chamber; first and second transfer vessels; and a plurality of fluid communications closed from communication with the atmosphere. conduit means for establishing a flow path, the conduit means in communication with the first centrifugal container and for directing whole blood into the first and second components in response to centrifugal force. a first clamping means operative to introduce whole blood from a donor into the first centrifuge container for separation into fractions; a second clamping means operative to return the first component from the blood donor to the donor; said second centrifuge for further separating the fraction into third and fourth components in response to centrifugal force. a third clamping means in communication with the first centrifuge vessel and the second vessel for transfer to the heart vessel; and a third clamping means for transferring the third component into the first transfer vessel. a fourth clamping means in communication with the second centrifuge vessel and the first transfer vessel; and a fourth clamp means for transferring the fourth component into the second transfer vessel; Container and and a fifth clamping means in communication with the second transfer container; and a fifth clamping means for diverting the fourth component from the second transfer container for return to the donor. The front is characterized in that it includes a sixth clamping means in communication with the front. system. 2. further comprising a third transfer vessel, and said conduit means is configured to carry said first component; the second clamp for diverting blood from the donor for transfer into the third transfer container; 2. The system of claim 1, including a seventh clamping means in communication with the stage and the third transfer vessel. 3. further comprising a source of sterile anticoagulant solution and a source of sterile saline solution, and said conduit means includes an eighth clamping means for introducing an anticoagulant solution into said system and a source of saline solution. and a ninth clamping means for introducing the system into the system. 4. The first and second centrifuge containers are each made of a material suitable for withstanding high-speed centrifugation. A system under paragraph 1 or paragraph 2 that is made of materials. 5. The system of clause 4, wherein said material is plasticized polyvinyl chloride. 6. Clause 1 or 2, wherein at least a portion of each of said transfer containers comprises a material endowed with predetermined physical properties that favor long-term storage of the blood components transferred therein. system of terms. 7. said third component comprises platelets and said first transfer container comprises improved blood The system of clause 1 or clause 2, which is made of a material that has physical properties with improved gas permeation properties for platelet survival. 8. The third component includes platelets, and the first transfer vessel has gas permeable properties made of polyvinyl chloride plasticized with di-2-ethylhexyl phthalate. 9. The system of clause 8, wherein said material is a polyolefin material. 10. The system of clause 8, wherein said material is plasticized with tri-2-ethylhexyl trimellitate. 9. The system of claim 8, wherein said fourth component comprises platelet-poor blood and said second transfer container contains said blood. Platelets are made of materials with relatively high low temperature strength to facilitate freezing of poor plasma. The first or second term system that is 12. The system of clause 11, wherein the second transfer vessel comprises a polyolefin material. 13. said first component contains red blood cells, and said third transfer container contains blood during storage; The system of clause 2 is made of a material that has physical properties that inhibit hemolysis of the bulb. 14. The material is polyvinyl chloride plasticized with di-2-ethylhexyl phthalate. The system of Section 13 which is a rule. 15. The system of clause 2, wherein the first component includes red blood cells and the third transfer container includes a red blood cell nutrient solution. 16. The pre-melting solution contains saline, adenine and glucose. stem. 17. The system of clause 16, wherein the solution further comprises annitol. 18. Each of the above technical means is capable of implementing the above system in the manner specified in Clause 1 or Clause 2. 2. The system of paragraph 1 or 2, comprising a length of flexible tubing integrally connected to the stem and the respective container. 19. At least one of the means includes normally closed first and second connector means dividing the one means into two parts each normally closed from communication with the atmosphere; Each of the connector and lid means has a portion thereof facing each other and in contact to selectively mechanically connect the first and second connector means. means for forming the fluid passageway through the facing portion only in response to exposure to an energy source sufficient to effectively sterilize the fusible means of the facing portion; 2. The system of claim 1 or claim 2, comprising means operative to melt the liquid into a liquid. 20. The meltable means of the facing portion is adapted to hermetically seal the fluid passageway. the system of clause 19 further operative to fuse the periphery of said fluid passageway when the sea urchin melts; Tem. 21. Each of the fusible means of the facing portion is made of a radiant energy absorbing material and is injected with sufficient radiant energy to effectively sterilize the fusible means. - The system of clause 20 that melts in response to exposure to a source. 22, the fluid passageway formed through the connector means provides a small The system of clause 19 which provides a probability of non-sterility of at least 10-6. 23. The technique includes a plurality of flexible fluid conduits and further includes a small number of body conduits having side walls. supporting at least a portion of the fluid conduit and arching the other portion of the fluid conduit outwardly from one of the side walls to accommodate operative contact with a pump rotor associated with the processing device; and said - toward an upright, freestanding position generally perpendicular to the side wall. and means for supporting in a predetermined arcuate shape resiliently biased. 24, at least two of the fluid conduits arch within the contour of the housing and outwardly of the side wall and are resiliently biased toward an upright, freestanding position generally perpendicular to the side wall; the outwardly arched portions of the two fluid conduits being adapted for separate operative contact with spaced apart pump rotors associated with the processing device; 23. The system of clause 23, located in spaced non-continuous relationship along said - sidewall, such that: Mu. 25, at least two of the fluid conduits arch within the contour of the housing and outwardly from one of the side walls and are resiliently biased toward an upright, freestanding position generally perpendicular to the side wall; The conduit is supported in a predetermined arc shape, and one of the conduit curved outwardly is attached to the processing device. The outside of the other of said conduits is adapted for simultaneous working contact with the associated pump rotor. 23. The system of clause 23, which is located circumferentially adjacent to the side-curved portion. 26. Increased yield suitable for use with in vitro blood processing devices having centrifugation chambers. It is a hybrid component collection system, and it is a means of not collecting all blood from a converter, a means to return all blood components to a convergent, and to be centrifuged. first and second centrifuge vessels suitable for positioning within the separation chamber; a first transfer vessel made of a material having physical properties of improved gas permeability; and a second transfer vessel; a source of sterile anticoagulant solution and a source of sterile saline, and conduit means for establishing a plurality of fluid passageways closed from communication with the atmosphere, the conduit means for centrifuging the whole blood. a first technique between said removal means and said first centrifugation container for introducing the red blood cells into said first centrifugation container for separation into red blood cells and platelets in response to said first centrifugation container; a second technique between said first centrifugation container and said return means for returning; and further separating platelet-rich plasma into platelets and platelet-poor blood in response to centrifugal force. a third technique between the first centrifuge vessel and the second centrifuge vessel for transferring platelets into the second centrifuge vessel for transferring platelets into the first transfer vessel; a fourth technique between said second centrifuge container and said first transfer container for transfer; and a fourth technique for transferring platelet-poor blood into said second transfer container. a fifth technique between the second centrifuge container and the second transfer container; a sixth technique between said fifth technique and said return means for diverting platelet-poor plasma from said second transfer container for return to a donor; and an anticoagulant solution. and a ninth means for introducing saline into the system. 27, further comprising a third transfer container associated therewith having a material having physical properties that inhibit hemolysis of the red blood cells during storage, and said conduit means directing the red blood cells into said third transfer container. said second technique for diverting blood from the donor for transfer to 27. The system of claim 26, including a seventh technique between said third transfer container. 28. The second transfer container has a relatively high The system of paragraph 26 or paragraph 27, which is made of a material with high low temperature strength. 29. The system of claim 28, wherein the first transfer vessel is constructed of a material having gas permeability properties that pass through polyvinyl chloride plasticized with di-2-ethylhexyl phthalate. 30. The system of clause 29, wherein said material is a polyolefin material. 31. The material of the first transfer vessel is tri-2-ethylhexyl trimellitate. 29. The system of paragraph 29, which is polyvinyl chloride plasticized with polyurethane. 32. The system of paragraph 28, wherein said second transfer vessel comprises a polyolefin material. Mu. 33, the third transfer vessel is a polymer plasticized with di-2-ethylhexyl phthalate. 29. The system of paragraph 28 comprising polyvinyl chloride material. 34. The system of paragraph 28, wherein the third transfer container contains an erythrocyte serum # solution. 35. The system of paragraph 34, wherein the solution contains saline, adenine and glucose. stem. 36. The system of paragraph 35, wherein the solution further comprises mannitol. 37. Clause 26 or 37, wherein each of said means comprises a length of flexible tubing integrally connected to said system and the respective container in the manner specified in clause 26 or 27. 27 section system. 38. At least one of said means includes normally closed first and second connector means dividing said one means into two parts each normally closed from communication with the atmosphere; Each of the connectors has a portion of each face-to-face means for selectively mechanically interlocking said first and second connector means by contacting said facing portions with energy sufficient to effectively sterilize the meltable means of said facing portions; said fluid communication through said facing portion only in response to exposure to a source; 28. The system of clause 26 or clause 27, including means operative to melt so as to form a channel. 39. The meltable means of the facing portion is configured to seal the fluid passageway. 39. The system of clause 38 further operative to fuse the periphery of said fluid passageway when the sea urchin melts. Tem. 40. Each of the fusible means of the facing portion is made of a radiant energy absorbing material and is injected with sufficient radiant energy to effectively sterilize the fusible means. - The system of paragraph 39 which melts in response to exposure to a source. 41, the fluid passageway formed through the connector means a small 41. The system of clause 40, which provides a probability of non-sterility of at least 1o-6. 42, the technique includes a housing including a plurality of flexible fluid conduits and further having sidewalls; and a pump associated with the processing device for supporting at least a portion of the fluid conduit within the contour of the housing means and for supporting at least a portion of the one fluid conduit within the contour of the housing means and for supporting at least a portion of the fluid conduit within the contour of the housing means and for supporting at least a portion of the fluid conduit within the contour of the housing means and a pump associated with the processing device. a predetermined predetermined predetermined portion arched outwardly from one of said side walls to accommodate operative contact with the protor and resiliently biased toward an upright freestanding position generally perpendicular to said side wall; and means for supporting in an arcuate configuration. 43, at least two of the fluid conduits are resiliently attached within the contour of the housing and arching outwardly from one of the side walls and toward an upright, freestanding position generally perpendicular to the side wall; the outwardly arched portions of the two fluid conduits are in separate operative contact with spaced apart pump rotors associated with the processing device; the system of clause 42, being located in spaced apart non-continuous relationship along said sidewall, so as to be compatible; Mu. 44, at least two of the fluid conduits arch within the contour of the housing and outwardly from one of the side walls and are resiliently biased toward an upright, freestanding position generally perpendicular to the side wall; The conduit is supported in a predetermined arcuate shape, and the outwardly bent portion of one of the conduits is attached to the processing device. The outside of the other of said conduits is adapted for simultaneous working contact with the associated pump locus. 42. The system of clause 42, which is located concentrically adjacent to the side-curved portion.