WO2020006418A2 - Composite fluid bag system holder - Google Patents

Abstract

Embodiments of a system box for holding a container system and methods for separating composite fluids are described. In embodiments, a container system may be a blood container system used to collect blood, separate the blood into components, store the components, and utilize the components in patients. The system box may hold the blood container system. Processes can then be performed to separate components from the blood.

Description

COMPOSITE FLUID BAG SYSTEM HOLDER

Background

This application claims priority to U.S. Provisional Patent Application No. 62/691,941 filed June 29, 2018, entitled COMPOSITE LIQUID BAG SYSTEM HOLDER, which is hereby incorporated by reference in its entirety.

Background

There are many fluids including biological fluids that are separated into components. The components may then be utilized after separation. One example of a biological fluid that is separated into components is whole blood. Conventionally, whole blood obtained by blood donations is separated into its components such as red blood cells, platelets and plasma. The components may then be individually transfused to a patient. It is believed that component transfusion, instead of transfusion of whole blood, may lessen the burden on a patient's circulatory system and reduce possible side effects of transfusion.

Whole blood obtained by blood donation may be centrifuged to separate the whole blood into its components. For example, the whole blood may be separated into a PPP (platelet poor plasma) fraction, a CRC (concentrated red blood cells) fraction, and buffy coat. The buffy coat may contain leukocytes, platelets and red blood cells. Typically, the buffy coat has a large proportion of young fresh platelets, which may be further separated from the other components of the buffy coat.

As noted, whole blood may be separated into blood components including platelet poor plasma, concentrated red cells and buffy coat, which may be stored and transported in separate storage containers, e.g., bags. The storage bags may be connected by tubing to create a bag system. A bag system for storage of blood components may be mounted in a separator device, such as a centrifuge. Depending on the length of tubing, position of bags, and operation of the centrifuge it may be burdensome to position bags and route tubing when mounting a bag system in a centrifuge. In addition, there may be kinking (torsion or sharp bending) of tubing which may affect how the bag system operates du ring a separation process.

Embodiments of the present invention have been made in light of these and other considerations. However, the relatively specific problems discussed above do not limit the applicability of the embodiments of the present invention.

Summary

The summary is provided to introduce aspects of some embodiments of the present invention in a simplified form and is not intended to identify key or essential elements of the claimed invention, nor is it intended to limit the scope of the claims.

Some embodiments relate to a latch system that may include a shaft comprising a first end and a second end. A bracket may be connected to the shaft along a length of the shaft. The latch system may include a handle that may be connected to the bracket. A first hook may be connected to the first end of the shaft and a second hook may be connected to the second end of the shaft. In fu rther embodiments, the hand le may be further connected to a hinge. The handle may be rotatable around the hinge in at least a first direction. In embodiments, when the handle is rotated around the hinge it may move the bracket which may then rotate the shaft. The latch system may be part of a lid in a system box that in some embodiments may include a first corresponding hook and a second corresponding hook. When the lid is in a locked position, the first hook may be engaged with the first corresponding hook and the second hook may be engaged with the second corresponding hook. In embodiments, when the handle is rotated around the hinge in the first direction, the first hook may be disengaged from the first corresponding hook and the second hook may be disengaged from the second corresponding hook. The system may in embodiments further include a first sensor that may detect whether the first hook is engaged with the first corresponding hook and a second sensor that may detect whether the second hook is engaged with the second corresponding hook.

Other embodiments may be directed to branch connector holders that may include a first channel that may include a first bottom surface that may slope from a first end of the first channel to a second end of the first channel. The holder may additionally include a second channel that meets the first channel at an angle. The second channel may include a second bottom surface. In embodiments, the second bottom surface may slope from a first end of the second channel to a second end of the second channel. Other embodiments may include a spring positioned within the first chan nel and/or at least one spring positioned within the second channel. The holder may further include a plu rality of holes for securing the branch connector holder onto a system box.

Other embodiments may be direct to a system box for holding a container system. The system box may include an outer wall, a first chamber, a second chamber that may be at least partially defined by the outer wall, and a third chamber that may also be at least partially defined by the outer wall. In embodiments, the first chamber may be closer to an axis of rotation than at least the third chamber. In embodiments, the system box may also include a first guide member comprising a first guide channel and a space for a first valve. A first valve may be positioned within the space of the first guide member. A branch connector holder adjacent the first valve and the first guide member may be included in some embodiments of the system box. The branch connector holder may include a first branch connector channel that may include a first end and a second end. The second end of the first branch connector chan nel may have a horizontal level that may be substantially the same as a horizontal level of the first guide chan nel. In some embodiments of the system box, the branch connector holder may further include a second branch connector chan nel that includes a first end and a second end. The second branch connector channel may meet the first branch connector channel at the first end of the second branch connector channel along a length of the first branch connector channel. In other embodiments, the system box may include a second guide member with a second guide channel and a second space for a second valve. The second valve may be positioned within the second space of the second guide member. The second end of the second branch connector channel may have a horizontal level that may be su bstantially the same as a horizontal level of the second guide chan nel, in some embodiments.

Other embodiments of a system box may include a first chamber and a second chamber at least partially defined by an outer wall. The second chamber may be further from an axis of rotation than the first chamber. The system box may include a third chamber that is also at least partially defined by the outer wall. The third chamber may also be fu rther from the axis of rotation than the first chamber. The system box may fu rther include a tubing path that may hold a portion of tubing that fluid ly connects a first container positioned in the first chamber to a second container positioned in the second chamber. In embodiments, a distance between the axis of rotation and the tubing path may vary from a first location of the tubing path to a second location of the tubing path. In embodiments, the first location of the tubing path may be near the third chamber. The second location of the tubing path may be near the second chamber, in some embodiments. A portion of the tubing path may in some embodiments include a ledge. In other embodiments, a portion of the tubing path may be along an inside surface of the outer wal l. The system box may also in embodiments include a tubing guide that maintains tubing in the tubing path. For example, the tubing guide may in some embodiments include a pair of opposing tabs that prevent tubing from moving out of the tubing path. The tubing path may also include a second tubing guide in some embodiments, which may include a second pair of opposing tabs that also prevent tubing from moving out of the tubing path. The system box may fu rther include an in let holder positioned adjacent the second chamber. The inlet holder may include a channel that may be configured to hold an inlet for the second container of the container system.

Yet other embodiments may be directed to methods of separating components from a volu me of composite fluid. The methods may include loading a bag system onto a system box, which may include positioning a first bag (with composite fluid) of a bag system into a first chamber of the system box and routing a portion of tubing that connects the first bag to the second bag along a tubing path. The tubing path may have a varying radius with respect to an axis of rotation, so that a first point in the tubing path may have a larger radius than a second point along the tubing path. The method may further include positioning a second bag of the bag system into a second chamber of the system box and positioning an inlet of the second bag of the bag system in an inlet holder. The composite fluid may then be separated into at least two components. After separation, the bag system may be unloaded from the system box. At least one of the components may be stored in the second bag. In embodiments, the u nloading may include removing the inlet from the inlet holder and removing the portion of tubing from the tubing path. In some embodiments, the composite fluid may be blood, and the at least one of the components may include one or more of plasma, platelets, white blood cells, red blood cells and combinations thereof. In some embodiments, the composite fluid may be blood, and one of the components may be plasma. In some embodiments, the separating may include subjecting the composite fluid and bag system to a centrifugal field. The method may further include positioning a third bag of the bag system into a third chamber of the system box, in some embodiments. The third bag may include a volume of solution. In some embodiments, the method may include breaking a frangible to allow fluid communication between the third bag and the first bag. The frangible may be on the system box.

Other embodiments of a system box, for holding a container system, may include a first chamber with a first opening, a second chamber comprising a second opening and a tu bing holder adjacent the first chamber. In embodiments, the tubing holder may include a proximal end, a distal end, and a side wall defining an interior volume of the tubing holder. At the proximal end, the sidewal l may flare outwardly away from the interior volu me, in some embodiments. The system box may further include an outer wal l that partially defines the second chamber. I n embodiments, the outer wall may be curved. In some embodiments, a portion of the second chamber may be between the first chamber and the outer wall. Some embodiments of the system box may further include a third chamber. At least a portion of the third chamber may be between the first chamber and the outer wall in some embodiments.

Yet other embodiment of the system box may include a first chamber and a second chamber that may be at least partially defined by an outer wall. The second chamber may be fu rther from the axis of rotation than the first chamber. The system box may further include a third chamber that may also be at least partial ly defined by the outer wall. The third chamber, in some embodiments, may be fu rther from the axis of rotation than the first chamber. The system box may further include at least one sensor that senses an adaptor positioned in the first chamber. The sensor may in some embodiments determine whether the adaptor is a first adaptor or a second adaptor. The first adaptor may have a first weight and the second adaptor may have a second weight different from the first weight. A weight of the adaptor when added to a weight of a container of fluid positioned in the first chamber may equal at least some predetermined weight, in some embodiments. Brief Description of the Drawings

Non-limiting and non-exhaustive embodiments are described with reference to the following figures.

FIG. 1A illustrates a plan view of a container system according to an embodiment. FIG. IB illustrates a plan view of another container system according to an embodiment.

FIG. 2 il lustrates a perspective view of a centrifuge apparatus for separating blood according to one embodiment.

FIG. 3A illustrates a back perspective view of an embodiment of a system box.

FIG. 3B illustrates a front perspective view of an embodiment of a system box.

FIG. 3C illustrates a top perspective view of an embodiment of a system box.

FIG. 3D illustrates a top perspective view of an embodiment of a system box with some parts hidden.

FIG. 3E illustrates a bottom perspective view of an embodiment of a system box.

FIG. 3F illustrates a side perspective view of an embodiment of a system box.

FIG. 3G il lustrates a side perspective view of an embodiment of a system box.

FIG. 3 H illustrates a side perspective view of an embodiment of a system box.

FIG. 31 illustrates a side perspective view of an embodiment of a system box with some parts hidden.

FIG. 3J il lustrates a side perspective view of an embodiment of a system box with some parts hidden.

FIG. 3K illustrates a side perspective view of an embodiment of a system box with some parts hidden.

FIG. 3L illustrates a top perspective view of an embodiment of a system box with some parts hidden. FIG. 3M illustrates a side perspective view of an embodiment of a system box with some parts hidden.

FIG. 3N illustrates a side perspective view of an embodiment of a system box.

FIG. 30 illustrates a front perspective view of an embodiment of a system box with some parts hidden.

FIG. 3P illustrates a bottom perspective view of an embodiment of a system box with some parts hidden.

FIG. 4 illustrates a flow chart of a method for separating components from a composite fluid according to an embodiment.

Detailed Description

The principles of the present invention may be further understood by reference to the following detailed description and the embodiments depicted in the accompanying drawings. It should be understood that although specific features are shown and described below with respect to detailed embodiments, the present invention is not limited to the embodiments described below.

Reference will now be made in detail to the embodiments illustrated in the accompanying drawings and described below. Wherever possible, the same reference numbers are used in the drawings and the description to refer to the same or like parts. Although the description below may be made with respect to the separation of blood, embodiments may be used in separating components from any composite fluid, e.g., biological fluids, organic fluids, or inorganic fluids.

According to embodiments, a container system illustrated in FIG. 1A as bag system 10 may be used for separating components from composite liquids, such as by centrifuging. In one embodiment, whole blood containing a plu rality of components may be separated into three components, namely a low-density component (relative low-density component), a medium- density component (relative medium-density component) and a high-density component (relative high-density component) (in this embodiment, whole blood may be centrifuged into three components including plasma, buffy coat (platelets and plasma), and concentrated red cel ls), and containing and preserving the components separately in different bags.

As shown in FIG. 1A, the bag system 10 may include: a first bag 12 in which, a composite fluid, e.g., blood, containing a plu rality of components may be contained; a second bag 14 in which a medium-density component obtained by centrifuging the blood in the first bag 12 may be stored; a third bag 16 in which a low-density component obtained by centrifuging the blood in the first bag 12 may be contained; a first tu be 18 through which an upper portion of the first bag 12 and an inlet 13 of the second bag 14 may be connected and through which the low-density component and the mediu m-density component may be transported from the first bag 12 to the second bag 14; and a second tube 20 by which an outlet 15 of the second bag 14 and the third bag 16 may be connected and th rough which the low-density component may be transported from the first bag 12 to the third bag 16 by way of the first tu be 18 and the second bag 14.

The first bag 12, the second bag 14 and the third bag 16 may each be fabricated by a method in which flexible sheet materials made of a flexible resin such as polyvinyl chloride and/or polyolefin are placed on each other and are fused (by heat fusing or high-frequency fusing) or adhered to each other at peripheral sheet portions into a bag. A first sample bag 32 and a red cel l bag 38 may also be in the form of a bag. I n other embodiments, 12, 14, 16, 32, and 38 may be in some other form of a container.

An anticoagulant may in embodiments be preliminarily contained in the first bag 12.

The anticoagulant may be a solution, and non-limiting examples thereof include but are not limited to ACD-A solution, CPD solution, CPDA-1 solution, and heparin sodiu m solution. The proper amount of anticoagu lant corresponding to the amount of blood to be collected (e.g., 200 ml, 400 ml, 500 ml, etc.) may be included in first bag 12.

One end of a blood collection tube (proximal-side blood collection tube) 22 may be connected to an upper portion of the first bag 12. A clamp 23 by which a lu men in the blood collection tube 22 is closed and opened may be provided at an intermediate portion of the blood collection tube 22. One end of a sealing member (e.g., a frangible or clik-tip) 24 may be connected to the other end of the blood collection tube 22. The sealing member 24 may be configured so as to close the channel (which may be provided, at least in part, by a portion of sealing member 24) in an initial condition and to open the channel by a breaking operation.

Such a sealing member 24 as this may include a tube formed, for example, from a flexible resin such as vinyl chloride, and a tubular body which may be connected to the inside of the tu be in a liquid-tight manner, may be closed at one end thereof and may have a brittle part at a portion in the longitudinal direction thereof. To put the sealing member 24 into an open (communicating) state, the tu bular body may be bent from the outside of the tube by fingers or the like to thereby break the brittle part. Consequently, a channel in the tube which has been closed by the tu bular body is opened, whereby the sealing member 24 is put into an open state.

To the other end of the sealing member 24 may be con nected a first port 26A of a branch connector 26. To a second port 26B of the branch connector 26, one end of a blood collection tu be (distal-side blood col lection tube) 28 may be connected, and to the other end of the blood collection tube 28, a blood col lection needle 29 may be connected. Before use, a cap 27 A may be used to cover the blood collection needle 29, and, after use, a needle guard 27B may be mounted to the blood collection need le 29. The needle guard 27B may be so disposed as to be movable along the longitudinal direction of the blood collection tube 28. To a third port 26C of the branch connector 26, one end of a branch tube 30 may be connected. At an intermediate portion of the branch tube 30, a clamp 31 may be provided by which a channel in the branch tube 30 may be closed and opened. To the other end of the branch tube 30, bag 32 may be connected. At the time of collecting blood from a donor, a predetermined amount of blood may be first collected in sample bag 32, before collecting the blood in first bag 12. In this case, the sealing member 24 may be kept in a closed state (initial state), the clamp 31 may be in an open state, whereby the blood is inhibited from flowing to the blood collection tube 22 and to the first bag 12. The blood therefore may first flow into the sample bag 32 th rough the blood collection tube 28, the branch connector 26 and the branch tube 30.

A sampling port 34 may be connected to the sample bag 32, and, by attaching a blood collection tube to the sampling port 34, the collected blood may be sampled into the blood collection tube. The samples of collected blood may be used for testing. Depending on the use, the part(s) ranging from the branch con nector 26 to the sampling port 34 may be omitted.

The bag 14 may be used in embodiments to contain (store) buffy coat. Bag 14 may have a bag structure of a top-and-bottom form wherein the inlet 13 is provided at one end and the outlet 15 is provided at the other end. The bag 14 is so set as to have a necessary and sufficient capacity, taking into account the amount of buffy coat to be collected; though the capacity may be smaller than the capacity of the first bag 12. The bag 16 may contain (store) and preserve plasma.

The first tube 18 may be connected to an upper portion of the first bag 12. I n embodiments, a sealing member 17 (e.g., frangible, clik-tip, etc.) may be provided at that end portion of the first tube 18 which is located on the first side. The sealing member 17 may have the same, or a similar, configuration and function as sealing member 24, described above. I n addition, a first clamp 19 by which a channel in the first tube 18 may be closed and opened may be provided at an intermediate portion of the first tu be 18.

The second tube 20 may be connected at its one end to the outlet 15 of the bag 14 and may be connected at its other end to the bag 16. A second clamp 21, by which a channel in the second tube 20 may be closed and opened, may be provided at an intermediate portion of the second tube 20.

As shown in FIG. 1A, the bag system according to this embodiment may fu rther include a bag 38 into which concentrated red blood cells may be stored, a filter 36 which may be disposed between the first bag 12 and the red cell bag 38 and by which predetermined cells (e.g., leukocytes) may be removed, a third tube 40 con necting an upper portion of the first bag 12 and an inlet of the filter 36, and a fou rth tube 42 th rough which an outlet of the filter 36 and the red cel l bag 38 may be con nected. In some embodiment, the filter 36 is configured as a leukocyte removal filter.

In other embodiments, bag 38 may store a preservative solution that may be added to first bag 12 after other components have been removed. In these embodiments, filter 36 may not be a part of system 10.

A clamp 43 by which a chan nel in the third tube 40 is closed and opened is provided at an intermediate portion of the third tube 40. A clamp 44 by which a channel in the fourth tube 42 is closed and opened is provided at an intermediate portion of the fou rth tube 42.

Each of the tu bes (inclusive of the first tube 18 and the second tube 20) in the bag system 10 may be made of a transparent flexible resin and a lumen extending between opposite ends of the tube. Each of the clamps (inclusive of the first clamp 19 and the second clamp 21) may be a standard pinch clamp in some embodiments. In addition, in some embodiments, the clamps may have different colors according to the locations of use and their intended use. At the time of sterilization and during stock before use of the bag system 10, each of the clamps may be in an open state and the inside of each of the bags is in communication to uniformly sterilize the system.

FIG. IB illustrates another container system, e.g., bag system 100 that may be used for separating components from composite fluids, such as by centrifuging. In one embodiment, blood containing a plurality of components may be separated into components, namely a low- density component (relative low-density component) and a high-density component (relative high-density component) (in this embodiment, whole blood may be centrifuged into plasma and concentrated red cells) and containing and preserving the components separately in different container, e.g., bags.

As shown in FIG. IB, the bag system 100 may include: a first bag 102 in which, a composite fluid, e.g., blood, containing a plu rality of components may be contained; a second bag 104 into which filtered blood from the first bag 12 may be stored after filtration th rough filter 112; a third bag 106 in which a low-density component obtained by centrifuging the blood in the second bag 102 may be contained; a first tube 110 th rough which an upper portion of the first bag 102 and the filter 112 may be connected and th rough which the blood may be transported from the first bag 102 to the filter 112; a second tube 114 through which the filter 112 and the second bag 104 may be connected and th rough which the blood may be transferred from the first bag 102 to the second bag 104; a third tube 116 through which an upper portion of the second bag 104 and the third bag 106 may be connected and th rough which the low-density component may be transported from the second bag 104 to the third bag 106 through a tube branch connector (e.g., y connector 118) that connects third tube 116 to a fourth tube 120 which is connected to third bag 106; a fifth tube 122 may be connected to branch con nector 118 and fourth bag 108 through which a preservative solution may be transferred from fourth bag 108 into second bag 104 which may include the high density component, e.g., red blood cells.

As noted above, the containers, e.g., bags 102, 104, 106, and 108 may each be fabricated by a method in which flexible sheet materials made of a flexible resin such as polyvinyl chloride and/or polyolefin are placed on each other and are fused (by heat fusing or high- frequency fusing) or adhered to each other at peripheral sheet portions into a bag. A first sample container may also be in the form of a bag 134. In other embodiments, 102, 104, 106, 108, and 134 may be in some other form of a container.

An anticoagu lant may in embodiments be preliminarily contained in the first bag 102. The anticoagulant may be a solution, and non-limiting examples thereof include but are not limited to ACD-A solution, CPD solution, CPDA-1 solution, and heparin sodiu m solution. The proper amount of anticoagulant corresponding to the amount (e.g., 200 ml, 400 ml, 500 ml, etc.) of blood to be collected may be included in first bag 102.

One end of a blood collection tube (proximal-side blood collection tube) 140 may be connected to an upper portion of the first bag 102. The other end may be con nected to a sealing member (e.g., a frangible or clik-tip) 128. The other end of the sealing member 128 may be connected to a first port of a branch connector 130. The sealing member 128 may be configured so as to close the channel (which may be provided, at least in part, by a portion of sealing member 128) in an initial condition and to open the channel by a breaking operation.

As described above, such a sealing member 128 as this may include a tube formed, for example, from a flexible resin such as vinyl chloride, and a tu bular body which may be connected to the inside of the tube in a liquid-tight manner, may be closed at one end thereof and may have a brittle part at a portion in the longitudinal direction thereof. To put the sealing member 128 into an open (communicating) state, the tubular body may be bent from the outside of the tube by fingers or the like to thereby break the brittle part. Consequently, a channel in the tube which has been closed by the tubular body is opened, whereby the sealing member 128 is put into an open state.

A blood col lection tube (distal-side blood collection tube) 126 may be connected to a second port of the branch connector 130. To the other end of the blood collection tube 126, a blood collection port 124 may be connected (a needle may be connected to blood collection port 124).

To a third port of the branch con nector 130, one end of a branch tube 132 may be connected. At an intermediate portion of the branch tube 132, a clamp 142 may be provided by which a channel in the branch tu be 132 may be closed and opened. To the other end of the branch tube 132, a container, e.g., bag 134 may be connected. At the time of collecting blood from a donor, a predetermined amount of blood may be first collected in sample bag 134, before collecting the blood in first bag 102. In this case, the sealing member 128 may be kept in a closed state (initial state), the clamp 142 may be in an open state, whereby the blood is inhibited from flowing to the blood collection tube 140 and to the first bag 102. The blood therefore may first flow into the sample bag 134 th rough the blood collection tube 126, the branch connector 130 and the branch tube 132.

A sampling port 136 may be connected to the sample bag 134, and, by attaching a blood collection tube to the sampling port 136, the collected blood may be sampled into a blood collection tube. The samples of collected blood may be used for testing. Depending on the use, the part(s) ranging from the branch con nector 130 to the sampling port 136 may be omitted.

The bag systems 10 (FIG. 1A) and 100 (FIG. IB) may be used, in embodiments for example, by being mounted to a centrifuge apparatus 200 as shown in FIG. 2. This apparatus 200 may be used for separating blood. It is noted that although FIG. 1A and IB il lustrate a specific embodiment of a system with containers, e.g., bags, and tubing connected in a particular way, other embodiments may provide systems with different con nections. For example, with respect to system 10, in some embodiments, tu be 40 and tube 18 may be connected to a branch connector, such as branch connecter 26. A tube may con nect the branch connector to bag 12, with tube 40 and tube 18 also being connected to the branch connector. As another example, in some embodiments, bag 14 may not be in-line with bag 16 and instead may be connected to a branch connector that is also con nected to tube 18. These are merely some examples and the present invention is not limited to any specific connections or arrangement of tubes and bags.

For pu rposes of illustration, a method for using the bag system 10 (consistent with one embodiment) will be explained. As shown in FIG. 2, the centrifuge apparatus 200 may be box shaped, and may include an openable/closable cover 204 at the top, a centrifugal d rum (means for centrifuging) 208 in the inside, six, unit insertion holes 212 provided at regu lar angular intervals inside the centrifugal dru m 208, and six system boxes 216A-F inserted in respective ones of the unit insertion holes. The apparatus 200 may be operated based on Ul controls on a console section 220 provided at the front surface, which may be controlled by a microcomputer, and may be configured to display predetermined information on a display 224.

In embodiments, the bag system is loaded onto a system box such as system box 216C. The system box has chambers and featu res that allow the tubing and bags to be positioned in the system box. Examples of some features of a system box are described below. The system box may be already installed in apparatus 200 before the bag system is loaded onto the system box. In some embodiments, the system box may be out of the apparatus and the system box may be positioned inside a separation apparatus such as centrifuge apparatus 200 after the bag system is loaded. It is noted that although the system box 216C is shown with a particular shape, in other embodiments (such as the ones described below) the shape may be different and correspond to the shape of unit insertion holes in the separation apparatus.

In the embodiment of FIG. 2, apparatus 200 has six slots where six system boxes 216A- F may be loaded into apparatus 200. In embodiments, system boxes 216A-F are loaded into apparatus 200. Six bag systems, e.g., system 10, may then be loaded into apparatus 200 with one bag system being loaded into each of system boxes 216A-F. Each of the bag systems mounted into system boxes 216A-F may include a bag with a composite fluid, e.g., whole blood. Apparatus 200 creates a centrifugal field by spinning centrifugal drum 208 and system boxes 216A-F around the axis of rotation 228. The centrifugal field then separates the composite fluid loaded onto system boxes 216A-F into components, e.g., whole blood into, plasma, buffy coat, and red blood cells. As may be appreciated, the strength of the centrifugal field in apparatus 200 increases as you move away from the axis of rotation 228.

For pu rposes of further illustration, a method for using the bag system 100 (consistent with another embodiment) will be explained. In embodiments, portions of the bag system 100 are loaded onto a system box such as system box 216C. Initially, whole blood in bag 102 (as collected from a donor) is filtered through filter 112 (to filter platelets and white blood cells) and transferred into bag 104. Tube 114 is then sealed to separate filter 112 and bag 102 from bags 104, 106, and 108 leaving bag system 100A (FIG. IB).

Six bag systems, e.g., 100A, may then be loaded into apparatus 200 with one bag system

100A being loaded into each of system boxes 216A-F. Each of the bag systems mounted into system boxes 216A-F may include a bag with filtered composite fluid, e.g., filtered whole blood. Apparatus 200 may then create a centrifugal field by spinning centrifugal drum 208 and system boxes 216A-F around the axis of rotation 228. The centrifugal field may then separate the composite fluid loaded onto system boxes 216A-F into components, e.g., plasma and red blood cel ls. As may be appreciated, the strength of the centrifugal field in apparatus 200 increases as you move away from the axis of rotation 228.

FIGS. 3A-3P il lustrate various views of a system box 300 according to different embodiments. In some embodiments, system box 300 may be used as one or more system boxes 216A-F (FIG. 2). Although some specific featu res of system box 300 are il lustrated in FIGS. 3A-3P and described below, embodiments are not limited to any one individual feature or specific combination of featu res. Some embodiments may include only one feature described below and illustrated in the figures, while others may include a combination of the featu res described and illustrated. Also, other features, not described below, may be included in other embodiments with or without the features described below.

As shown in FIGS. 3B-3D, system box 300 includes a chamber 304, where a bag of a composite fluid (e.g., blood) may be positioned, chamber 306, and chamber 308. When system box 300 is in a separation apparatus, e.g., apparatus 200, and spun, it may rotate arou nd axis of rotation AA. FIGS. 3B-3D il lustrate that chamber 304 may be closer to axis of rotation AA than chamber 306 and chamber 308.

In addition, chamber 304 includes a lid 316 that covers an opening of chamber 304. A handle 317 on the lid 316 al lows an operator to move lid 316 from an open position to a closed position. As described below with respect to FIG. 3N, lid 316 may have a number of positions, e.g., locked, unlocked, partially open, and/or open, for example.

In embodiments, hand le 317 may have ergonomic features that allow an operator to easily manipulate the handle 317 and a latch system (e.g., latch system 400 (FIGS. 3I-3M)) that operates to lock and u nlock lid 316. For example, the hand le 317 may have a mushroom design with a head that has smooth, rounded edges that easily and comfortably fits within an operator's hand. In other embodiments, the hand le 317 may have a spherical, ellipsoid, prism, cylind rical, tear d rop, or other shape.

Fu rther, system box 300 includes a tubing segment holder 318, valves 320 and 322, guide members 321 and 323, tubing path 342, inlet holder 346, a frangible breaker 349, a sensor 382, and a branch connector holder 384. Additionally, lid 316 also includes features, which may engage with a latch system as described in more detail below.

FIGS. 3B-3D illustrate that system box 300 genera lly has a wedge shape with an outer wal l 331. As shown in FIGS. 3B-3D, outer wall 331 at least partially defines chamber 306 and chamber 308. The wedge shape corresponds to the shape of a space in a separation apparatus, e.g., apparatus 200 where the system box 300 may be placed for separating components from a composite fluid. It is noted that in other embodiments, system box 300 may have other general shapes (e.g., cu be, cylinder, prism, etc.) that correspond to a space in a separation apparatus. Outer wall 331 of system box includes a cu rved outer surface 331A and an in ner surface 331B. Flowever, it is noted that in other embodiments, outer wall 331 and surfaces 331A and 331B may have straight features, curved features, projections, perforations, or a combination of featu res.

System box 300 also includes a tubing segment holder 318. According to embodiments, segmented portions of tu bing may be stored in the holder 318, which may be designed specifically for holding segments of tubing with blood. Tubing segment holder 318 may in embodiments be angled, with respect to an axis of rotation (e.g., axis AA) such that when a centrifuge apparatus is in operation, centrifugal force will keep the tube segments in the holder 318. A user may also be able to easily verify whether the Hct of the blood is within a threshold range and whether there is any hemolysis of the blood in the tubing segments.

FIG. 3 H show a view of tubing segment holder 318 in system box 300. As shown in these figures, holder 318 may have a sidewal l 319 that defines an interior volume of the tubing segment holder 318, which may be used to hold segments of tubing. Tubing segments may be placed inside the tubing holder via a proximal end 318A. The tubing holder 318 may be attached to the system box 300 at distal end 318B. In the embodiments shown, proximal end 318A is flared. That is, sidewal l 319 flares outwardly away from the interior volu me of holder 318. In other words, at proximal end 318A, a diameter of the interior volu me of tubing segment holder 318 increases. As may be appreciated, having the proximal end flared out, makes it easier for an operator to insert tubing segments into tu bing segment holder 318.

Another feature of some embodiments of tu bing holder 318 is the ability to easily remove and replace tubing segment holder 318. In situations where a tu bing segment bu rsts and blood leaks in tubing segment holder 318, the tubing segment holder 318 may be easily removed to be cleaned and/or replaced. In embodiments, holder 318 may be secured to box 300 at distal end 318B with a fastener, e.g., a screw. The fastener may be removed to disconnect holder 318 from box 300 to clean and/or replace holder 318.

Handle 317 may be used by an operator to open and close lid 316. In embodiments, handle 317 may also be part of a latch system 400 that operates to lock lid 316 in a locked position or to unlock lid 316 so that is in an unlocked position. As described in detail below and illustrated in FIG. 3N, lid 316 may have a number of positions, e.g., locked, u nlocked, partially open, and open, for example.

FIGS. 3I-3M illustrates views of system box 300 with some components hidden/removed in order to more clearly show various featu res of the latch system 400. As shown in FIGS. 3I-3M, lid 316 includes arms 350A and 350B that operate as part of the latch system 400. The arms 350A and 350B in embodiments may be formed in part by a shaft 402, which extends beyond either side of the lid 316 as part of arms 350A and 350B. Attached to arms

350A and 350B are hooks 352A and 352B, which engage with corresponding hooks 404A and 404B respectively (FIG. 3J). It is noted that although corresponding hooks 404A and 404B are shown in isolation this is done merely for illustrative purposes, in embodiments, they may be attached to portions of system box 300.

Handle 317 may also operate as part of the latch system 400. Handle 317 may be attached to hinge 406 and may engage bracket 408. As hand le 317 moves around hinge 406, it may engage with and move bracket 408 (FIG. 3K), which is attached to shaft 402. When bracket 408 is moved, it may rotate shaft 402 and rotate hooks 352A and 352B. This may al low hooks 352A and 352B to engage or disengage corresponding hooks 404A and 404B to lock or un lock lid 316. For example, in one embodiment, when hand le 317 is pushed in the direction indicated by arrow 410 (FIG. 31), shaft 402 may rotate in the direction indicated by arrow 412. The rotation of shaft 402 may disengage hook 352A from corresponding hook 404A and hook 352B from corresponding hook 404B, which may unlock lid 316. In embodiments, latch system 400 may include a spring 403 (FIG. 3K) in contact with bracket 408 and/or hand le 317 that biases the shaft 402 and/or handle 317, attached to bracket 408, so that the hooks 352A and 352B may be positioned as shown in FIG. 31. When handle 317 is pressed downward as indicated by arrow 414, bracket 408 and or handle 317 may push against the spring 403. The force of pressing the handle 317 downward may force shaft 402 to rotate opposite arrow 412 allowing hook 352A to engage corresponding hook 404A and hook 352B to engage corresponding hook 404B thereby locking lid 316. Latch system 400 may also include sensors in some embodiments. For example, sensor 420B (FIG. 3M) may detect whether hook 352B is engaged with corresponding hook 404B. There may also be a corresponding sensor 420A (FIG. 31) that may detect whether hook 352A is engaged with corresponding hook 404A. The sensors may aid in the system determining whether lid 316 is locked or unlocked. FIG. 3N illustrates that lid 316 may have a nu mber of different states or positions. In

FIG. 3N, lid 316 is illustrated as initial ly being in a locked position 316A. As noted above, in embodiments, this may mean that hook 352A is engaged with corresponding hook 404A and hook 352B is engaged with corresponding hook 404B. 316B illustrates lid 316 in an unlocked state. As noted above, in embodiments, this may mean that hook 352A is disengaged from corresponding hook 404A and hook 352B is disengaged from corresponding hook 404B. 316C illustrates lid 316 in a partial ly open position. In embodiments, this may refer to lid 316 being in an u nlocked state and moved so as to begin to uncover chamber 304. As illustrated in FIG. 3N, when in position 316C, lid 316 has not yet triggered (e.g., pressed) sensor 382. 316D il lustrates lid 316 in an open position. In embodiments, this may refer to lid 316 being in an un locked state and moved so that chamber 304 is substantially u ncovered. As illustrated in FIG. 3N, when in position 316D, lid 316 has triggered (e.g., pressed) sensor 382. It is noted that lid 316 may have other positions or states that are between one or more of positions or states 316A, 316B, 316C, and/or 316D. This description is merely provided for explanatory pu rposes.

In embodiments, the position of lid 316 may affect the state of valves 320 and 322 (FIG.

3B). In embodiments, a sensor, such as sensor 382, may indicate when lid 316 is open beyond a predetermined amou nt, e.g., in an open position (316D). When lid 316 is in an opened position, it may press sensor 382 downward. In embodiments, the valves 320 and 322 may remain in an open state when sensor 382 is pressed. When lid 316 is moved toward a closed position 316C, sensor 382 may no longer be pressed. In embodiments, this may trigger valves 320 and 322 to close. In embodiments, the distance between lid 316 and sensor 382 may be such that lid 316 may be at least partially open 316C without triggering sensor 382 and consequently having valves

320 and 322 opened. This may be useful for exam ple, when an operator wants to partially open lid 316 to inspect a bag of composite fluid in chamber 304 without having valves 320 and/or 322 open.

In some embodiments, box 300 may include guide members 321 and 323 (FIG. 3B). Guide members 321 and 323 may provide featu res that guide tubing into valve openings and maintain the tubing in the valve openings. Guide members 321 and 323 may include a space 321A and 323A for a valve (e.g., 320 and 322) and a guide channel 321B and 323B where tubing may be positioned. The guide channels 321A and 321B may position and maintain tubing in the openings of valves 320 and 322.

System box 300 may also include branch connector holder 384, which may hold a branch connector (Y connector, T connector, etc.) that may be part of a bag system, e.g., system 10, 100, or 100A. Branch connector holder 384 includes a first channel 385 and a second channel 387 (FIG. 3C and 3D). The first channel includes a bottom surface, a first end 385A, and a second end 385B (FIG. 3D). The second channel includes a bottom surface, a first end 387 A, and a second end 387B (FIG. 3D). As shown in FIG. 3D, channel 387 meets chan nel 385 at a first end 387A of channel 387 along a length of channel 385. Channel 387 meets channel 385 at an angle that may vary from 90 degrees to 1 degree with respect to channel 385.

In embodiments, branch connector holder 384 may include featu res that allow a bag system to be more easily loaded into system box 300. As one example, branch connector holder 384 may have a tapered thickness. For example, as shown in FIG. 3C, holder 384 may adjacent valves 320 and 322. An operator inserting a bag system into system box 300 may insert a branch connector (e.g., Y connector) into holder 384 and tubing into valves 320 and 322. The tapered thickness of holder 384 (see FIG. 3G) may make it easier for an operator to insert tubing into valves 320 and 322. Flolder 384 is angled so that it is thinner on one side (384A) and thicker on another side (384B) closer to valves 320 and 322. Being thicker on the side closer to the valves lifts the horizontal level (line BB) of the branch connector closer to (or to about the same horizontal level) as the valve opening and the guide channels 321B and 323B where the tubing may be inserted. By raising the branch connector level, an operator may more easily insert tubing into valves 320 and 322 the guide channels 321B and 323B because the angle is straighter than if the horizontal level of the branch connector was lower or higher than the guide chan nels 321B and 323B and consequently the valve openings.

In other embodiments, the bottom surface of channels 385 and/or 387 may be designed to make it easier for an operator to insert tubing into valves 320 and 322. In embodiments, the bottom surface of channels 385 and/or 387 may be designed so that second ends 385B, 387B (FIG. 3D) are at substantially the same horizontal level as the guide chan nels (321B and 323B) in guide members 321 and 323. For example, the bottom surface of channels 385/387 may slope from a first end 385A, 387A to a second end 385B, 387B so that second end 385B, 387B is at substantial ly the same horizontal level as guide channels 321B and 323B. In other embodiments, branch connector holder 384 may include other features that provide for second end 385B, 387B to be at the substantial ly same horizontal level as guide chan nels 321B and 323B (FIG. 3G).

Flolder 384 may also have featu res that provide both security for holding branch connectors and flexibility for allowing different size branch connectors to be held. For example, holder 384 may include springs 386A and 386B (FIG. 3C) that include walls that flex to widen and shorten the width of the channel (e.g., channel 385) in holder 384. This allows a branch connector, placed in the channel 385 of holder 384, to be secured. Springs 386A and 386B may flex and apply a force to a branch connector in the channel keeping the branch connector secured in the channel. In other embodiments, the springs 386A and 386B may flex enough to allow different size branch connectors to fit within holder 384. This may be useful in embodiments in which different bag systems with different size branch connectors may be used with system box 300. Springs 386A and 386B may aid in accommodating a variety of bag systems. In other embodiments, one or more springs may also be in channel 387.

In embodiments, holder 384 may be attached to system box 300 with fasteners that make removal of holder 384 easy. These embodiments may allow for easy replacement of holder 384, such as for example, if springs 386A and 386B break or lose their flex. Branch connector holder 384 may have a plurality of holes 351A and 351B where fasteners may be positioned to secu re holder 384 to box 300.

System box 300 may also include a tubing path 342 (see FIG. 3B) where tubing is routed. In embodiments, when blood is being separated, tu bing path 342 may include tubing connecting a bag in chamber 304 to a plasma bag in chamber 306. As shown in FIG. 3B, at least a portion of a tubing path 342 may be positioned between the outer wall 331 and the first chamber 304. In embodiments, tubing path 342 may include a ledge that is located adjacent to the inner surface 331B of outer wall 331.

As shown in FIG. 3B, embodiments may provide for the tubing path 342 to have a decreasing radius with respect to axis of rotation AA, as pathway 342 travels from point 342A to point 342B. In other words, R1 (radius between axis AA and point 342A is longer than R2 (radius between axis AA and point 342B). This feature may provide for air to be pushed out of tubing running along tubing path 342. In the embodiments where blood is being separated, the design of having the radius (with respect to axis AA) of tubing path 342 decreasing (from point 342A and 342B) may provide for air to be pushed out of, and plasma to be positioned in, the tubing connecting a plasma bag in chamber 306 and the whole blood bag in chamber 304. The tubing with the plasma may be segmented and used in embodiments for testing discrete volume of plasma, for example. In embodiments, the first point 342A may be adjacent the third chamber

308. In embodiments, the second point 342B may be adjacent the second chamber 306. In addition to path 342, system box 300 may also include a bag inlet holder 346 (FIG.

3B). In embodiments, an inlet of a bag in chamber 306 may be secu red in holder 346. I n embodiments in which blood is being separated, an inlet of a plasma bag may be positioned in holder 346. Holder 346 may include a channel, with two tabs that secures the in let within inlet holder 346. As shown in FIG. 3C, inlet holder 346 is even closer to axis of rotation AA than point 342B of path 342. Again, the location of 346 (closer to the axis of rotation AA) ensu res that air is removed from tubing positioned in pathway 342 as described above.

In embodiments, system box 300 may also include tubing guides that may aid in maintaining tubing in the tubing path 342. For example, in embodiments, box 300 may include tubing guides 344A and 344B (FIG. 3B). The tubing guides may have any structure that aids in maintaining tubing in the tubing path 342. As shown in FIG. 3B, guides 344A and 344B include two opposing tabs.

In some embodiments, system box 300 may be part of a separation system that includes a plu rality of system boxes (e.g., system 200). There may be situations in which not all of the system boxes are loaded with fluid to be separated. In these embodiments, counter weights (e.g., dummies or dummy bags) may be loaded into one or more chambers 304, 306, or 308, in order to balance the separation system. As may be appreciated, a separation system may become unbalanced if some system boxes are left empty and others are fu ll of fluid to be separated. Accordingly, system box 300 may include magnet 390 (see FIG. 30) to for example pull counter weights (dummy or adaptor) toward a back wall where sensors may sense the type of counter weight. In embodiments, the counter weights placed in chambers 304, 306 and/or 308 may also include a component that aids in the sensing of the weights. For example, the counterweights may include magnets. Sensing the presence of the counter weights may indicate to the system not to perform steps such as movement of fluid (e.g., from chamber 304 to 306), which occurs when fluid is separated in the separation system. Magnet 390 may position the counter weights to ensu re they are in a position to be sensed by the sensors.

In some embodiments, different bag systems may be used with system box 300. For example, bag systems with smaller volumes of composite fluid for separation into components may be used. In order for the system box 300 to accommodate smaller volu mes for separation, adaptor(s) may be inserted into one or more chambers of system box 300. For example, an adaptor 500 may be placed in chamber 304 (see FIG. 30). The adaptor may fill up space that wou ld otherwise be filled with fluid. System box 300 may include an array of sensors 392 (see FIG. 3P) in order to sense that an adaptor is being used. In embodiments, the adaptor placed in chamber 304 may also include a component that aids in the sensing of the adaptor. For example, sensors 392 may be magnetic (e.g., hall sensors) and interact with magnets that may be part of the adaptor. Detection of the adaptor may indicate to the system to process the fluid in system box 300 differently than fluid positioned in other system boxes with larger volumes of fluid. In embodiments, sensors 392 may distinguish among different adaptors and/or counter weights, which may affect the processing in the system box. For example, a first adaptor may have a first weight, while a second adaptor may have a second weight different from the first weight. In embodiments, the system may be designed so that different volumes of fluid may be processed in chamber 304. In order to accommodate differences, adaptors may be of different weights so that the overal l weight in chamber 304, for example, is at least some predetermined amount. For example, if a standard donation of blood may weight about 0.4 kg, an adaptor may be selected that when added to the weight of the fluid approximates 0.4 kg. That is, if a donation weighs about 0.2 kg, an adaptor may be added that is about 0.2 kg to approximate 0.4 kg in the separation chamber. I n this way, different volu mes of fluid, of different weights, may be processed and the overall separation system (e.g., 200 ml, 400 ml, 500 ml, etc.) may remain balanced. In embodiments, sensors 392 may distinguish among different adaptors and/or counter weights. In some embodiments, the processing of fluid may be different depending on the different adaptors. For example, the centrifuge speeds may change, the amount of processing time, the amount of time between steps, may be different when different adaptors are used. As noted above, magnet 390 may position the adaptors to ensu re that they are in a position to be sensed by the sensors 392.

Fu rther, system box includes indicators 394A and 394B (FIG. 3C), which may indicate different states of portions of the system box 300. For example, the indicators 394A and 394B may be lights that indicate whether a bag system is loaded into system box 300. In other embodiments, the indicators may indicate whether the valves 320 and/or 322 are in an open or closed state. Also, in other embodiments, the indicators may indicate whether lid 316 is open, partially open, unlocked, and/or locked. In embodiments, indicators 394A and 394B may be lights (e.g., LED lights) that are on or off. In other embodiments, the indicators may have different colors that may indicate different states of different components in the system box 300. For example, green, red, or blue lights may indicate a different state such as one of the states of the lid 316 mentioned above.

Additionally, system box 300 also includes a frangible (or clik-tip) breaker 349 (FIG. 3D). The frangible breaker includes a pair of prongs 349A and a notch 349B (FIG. 3C and 3D). An operator may insert a frangible between the prongs 349A and into the notch 349B and manipu late the frangible to break the seal. In embodiments, prongs 349 may also be used to hang a bag of solution, e.g., MAP preservative solution, placed in chamber 308.

FIG. 4 illustrates a flow chart 450 for a process of separating components from a composite fluid. In one embodiment, the composite fluid may be blood, and the components may be one or more of plasma, platelets, white blood cells, buffy coat, red blood cells, and combinations thereof. Although the steps in flow chart 450 may be described below as performed by an operator, machines, or other apparatus, embodiments are not limited thereto. For example, some steps may be described as performed by an operator, while others are performed by one or more features of a system box or a separation apparatus (e.g., a centrifuge apparatus). This is done merely for illustrative purposes, and flow chart 450 is not limited to being performed in a specific way, e.g., by any specific device, featu re, or component.

Flow 450 starts at 452. At step 454, a bag system may be loaded onto a system box. The system box may be an embodiment of system box 300 shown and described above with respect to FIGS. 3A-P. The bag system may also be any suitable bag system that includes one or more bags, with one bag containing the composite fluid. In one embodiment, the bag system may be a blood bag system that is used to collect blood, separate blood into components, store separated components, and utilize the components in patients. Examples of bag systems include systems 10, 100, and 100A described above with respect to FIGS. 1A and IB.

As shown in FIG. 4, step 454 may include a nu mber of substeps. Some substeps are shown and described in FIG. 4, however, other steps (not shown) may be performed in other embodiments, e.g., positioning third, fou rth, etc. portions of tubing, closing a lid, etc. Further, the substeps may be performed in any order or in paral lel.

At substep 456 a branch connector may be positioned. This substep may involve positioning the branch connector in a holder, e.g., holder 384. In embodiments, the branch connector may be secu red into the holder. An operator may therefore push portions of the branch connector into channels of the holder.

At substep 458, tubing may be positioned in valves. In embodiments, the branch connector may connect one or more portions of tu bing that at substep 458 are then positioned in valve openings. For example, in embodiments, the holder 384 may be positioned adjacent valves 320 and 322. At substep 458, tubing may be positioned in the valve openings of valves

320 and 322, for example.

At su bstep 460, a first bag of the bag system may be positioned in a first chamber of the system box. The first bag may comprise the composite fluid, for example blood. In other embodiments, the first bag may be a bag in which one of the components, e.g., plasma, may be stored after separation. At substep 462 a first portion of tubing that con nects the first bag to a second bag of the bag system may be routed in the system box. Substep 458 may involve routing the tubing around guide posts. In some embodiments, the guide posts may be positioned to allow the tubing to be routed in different ways to accommodate different tubing lengths

At substep 464, sealed tubing segments may be placed in a tubing holder. In some embodiments, each segment of tubing may hold a volu me of composite fluid, e.g., blood. The tubing segments may be used as samples that provide information about the composite fluid, e.g., concentration of a component and/or provide an indication of the quality of the separation after components have been separated from the composite fluid. The sealed tubing segments may be formed by heating and melting portions of tubing that contain the composite fluid, e.g., blood, creating sealed segments of tubing with a volume of composite fluid. The tubing segments may be folded and placed in a tubing holder, e.g., tubing holder 318.

Flow 450 then passes to substep 466 where a first frangible may be broken to open fluid communication between the first bag and the second bag. In some embodiments, the frangible may be broken by closing a lid that includes a frangible breaking mechanism. In one embodiment, the frangible breaking mechanism may be a ridge on an interior su rface of a lid, e.g., lid 316 of system box 300.

At su bstep 468, a valve(s) may be closed. In some embodiments, su bstep 468 and 466 may be performed su bstantially simultaneously. For example, in one embodiment, by closing a lid over the first chamber, the frangible may be broken (466) and a valve may be closed (468). As noted above, a system box may include a latch system that provides for closing a valve. Latch system 400 described above, in embodiments, provides for closing one or more of valves 320 and 322 when lid 316 is closed.

Additionally, closing of the lid to both close a valve and break a frangible may also accomplish other functions. For example, in embodiments, when the lid is closed, the first bag may be completely surrounded to ensure that during separation the bag is not extended.

At substep 470, a second bag is positioned in a second chamber of the system box. Flow 450 then passes to substep 472, where an inlet of the second bag may be positioned in an inlet holder. In embodiments, the inlet holder may be closer to the axis of rotation than other points along the tubing path. This may aid in ensuring that a separated component is in a portion of tubing, as described above. For example, substep 470 may involve positioning the second bag in a second chamber, such as chamber 306, and substep 472 may involve positioning the inlet of the second bag in inlet holder 346.

Flow 450 may then pass to substep 474 where a second portion of tubing may be routed for example in a tubing path. In some embodiments, the tubing path may be located to allow one of the bags, e.g., the second bag of the bag system, to be fil led with a component separated from the composite fluid while pushing air out of the bag. As one example, the tubing path may be located so that when the system box is subjected to a centrifugal field, a portion of tubing is positioned in a higher force region, than an inlet port of the bag being filled with the component. This may al low the bag to be fil led with a component while air is pushed out of the bag and allow the component to fill a portion of the tubing con necting the first bag to the second bag. In embodiments, this may be accomplished as a result of the tubing path having a varying radius with respect to an axis of rotation, so that a first point in the tubing path has a larger radius than a second point along the tubing path (with respect to the axis of rotation). In embodiments, the second point along the tubing path may be adjacent an inlet for the second bag. As one example, the tubing path may be path 342, with the first point being 342A and the second point 342B. In these embodiments, substep 474 may involve routing tubing in tubing path 342.

At substep 476, a second frangible may be broken to open communication with a bag containing preservative solution, which may be performed after other substeps. The frangible may be broken using a different opener, for example, such as one provided adjacent a chamber for holding the bag of preservative solution, e.g., opener 349 (FIG. 3D). The additional frangible breaking steps may be performed before, after, or in parallel with substep 474.

Su bstep 478 may then be performed to position a third bag in a third chamber of the system box. The bag may be a bag for holding the preservative solution. For example, substep 478 may involve positioning a bag such as bag 108 in chamber 308.

Flow passes from step 454 to step 480 where the composite fluid in the first bag may be separated by the separation apparatus. The separation may be accomplished in any suitable way, some non-limiting examples including centrifugation, acoustic separation, gravity separation, etc. In one embodiment, a centrifuge apparatus, such as apparatus 200 is used to separate the composite fluid into components. For example, whole blood may be separated into plasma, a buffy coat (platelets and white blood cells), and red blood cells. As another example, filtered (from platelets and white blood cells) blood may be separated into plasma and red blood cel ls.

In those embodiments in which step 480 is performed, at least in part by a centrifuge apparatus, the system box, the bag system, and the composite fluid may be subjected to a centrifugal field, which may be generated by spinning the system box and the bag system loaded on the system box around an axis of rotation. For example, the system box may be installed in a centrifugal dru m 208 of apparatus 200 (FIG. 2). Apparatus 200 may then spin su bjecting the centrifugal dru m 208, the system box, the bag system, and the composite fluid to a centrifugal field. For example, in some embodiments, substeps 482 and 484 may be performed as part of performing step 480. At substep 482, apparatus 200 may spin the system box and bag systems at higher rotations per minute (RPMs) to effect sedimentation 482 of the components (e.g., red blood cel l, white blood cells, platelets, buffy coat, etc.) in the fluid. After sedimentation 482, apparatus 200 may spin the system box and bag systems at lower RPMs while transferring 484 the components from a first bag to one or more other bags. Once the components have been separated, there may not be a need to continue to spin at high RPMs, however, continuing to spin at a lower RPM may ensure that the components remain separated.

At step 486 the bag system may be u nloaded from the system box. The bag system may be unloaded from the system box, while the system box remains in the separation apparatus. In embodiments, step 486 may also involve a number of substeps. For example, in embodiments step 486 may involve, removing the inlet place in the in let holder at substep 472, removing the second portion of tubing from the tubing path routed at substep 474, removing bags from chambers, etc. These are merely some examples of substeps that may be performed and other substeps may be performed in other embodiments. Flow 450 then ends at 488.

Although flow 450 has been described with steps listed in a particular order, the present disclosure is not limited thereto. In other embodiments, steps may be performed in different order, in paral lel, or any different number of times, e.g., before and after another step. Also, as indicated above, flow 450 includes some optional steps/substeps. Flowever, those steps above that are not indicated as optional should not be considered as essential to the invention but may be performed in some embodiments of the present invention and not in others. It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and structu re of the present invention without departing from its scope. Thus, it should be understood that the invention is not limited to the specific embodiments or examples given. Rather, the invention is intended to cover modifications and variations.

Claims

WHAT IS CLAIM ED IS:

1. A latch system comprising:

a shaft comprising a first end and a second end;

a bracket con nected to the shaft along a length of the shaft;

a handle connected to the bracket;

a first hook connected to the first end of the shaft; and

a second hook connected to the second end of the shaft.

2. The latch system of claim 1, wherein the handle is further connected to a hinge.

3. The latch system of claim 1 or claim 2, wherein the handle is rotatable around the hinge in at least a first direction.

4. The latch system of any one of the preceding claims, wherein when the handle is rotated around the hinge it moves the bracket which then rotates the shaft.

5. The latch system of any one of the preceding claims, wherein the latch system is part of a lid in a system box.

6. The latch system of claim 5, wherein the system box comprises a first corresponding hook.

7. The latch system of any one of claim 5 or claim 6, wherein the system box comprises a second corresponding hook.

8. The latch system of any one of claim 6 or claim 7 , wherein when the lid is in a locked position, the first hook is engaged with the first corresponding hook.

9. The latch system of any one of claim 7 or claim 8, wherein when the lid is in the locked position, the second hook is engaged with the second corresponding hook.

10. The latch system of any one of claim 8 or claim 9, wherein when the handle is rotated around the hinge in the first direction, the first hook is disengaged from the first corresponding hook.

11. The latch system of any one of claims 8-10, wherein when the handle is rotated around the hinge in the first direction, the second hook is disengaged from the second corresponding hook.

12. The latch system of any one of claims 6-11, further comprising a first sensor that detects whether the first hook is engaged with the first corresponding hook.

13. The latch system of any one of the preceding claims 9-12, further comprising a second sensor that detects whether the second hook is engaged with the second corresponding hook.

14. A branch connector holder, comprising:

a first channel comprising a first bottom surface, wherein the first bottom surface slopes from a first end of the first channel to a second end of the first channel; and

a second channel that meets the first channel at an angle, wherein the second channel comprises a second bottom surface.

15. The branch connector holder of claim 14, wherein the second bottom surface slopes from a first end of the second channel to a second end of the second channel.

16. The branch connector holder of claim 14 or claim 15, further comprising at least one spring positioned within the first channel.

17. The branch connector holder of any one of the preceding claims, further comprising at least one spring positioned within the second channel.

18. The branch connector holder of any one of the preceding claims, further comprising a plurality of holes for securing the branch connector holder onto a system box.

19. A system box for holding a container system, the system box comprising: an outer wall;

a first chamber;

a second chamber at least partially defined by the outer wall;

a third chamber at least partially defined by the outer wall, wherein the first chamber is closer to an axis of rotation than at least the third chamber; a first guide member comprising a first guide channel and a space for a first valve; the first valve positioned within the space of the first guide member; and

a branch connector holder adjacent the first valve and the first guide member, the branch connector holder comprising a first branch connector channel comprising a first end and a second end, wherein the second end of the first branch connector channel has a horizontal level that is substantially the same as a horizontal level of the first guide channel.

20. The system box of claim 19, wherein the branch connector holder further comprises a second branch con nector channel comprising a first end and a second end, wherein the second branch connector channel meets the first branch connector channel at the first end of the second branch connector channel along a length of the first branch connector channel.

21. The system box of claim 19 or claim 20, further comprising a second guide member comprising: a second guide channel and a second space for a second valve.

22. The system box of claim 21, wherein the second valve is positioned within the second space of the second guide member.

23. The system box of any one of claims 21 or 22, wherein the second end of the second branch connector channel has a horizontal level that is substantial ly the same as a horizontal level of the second guide channel.

24. A system box for holding a container system, the system box comprising: a first chamber;

a second chamber at least partially defined by an outer wall, wherein the second chamber is further from the axis of rotation than the first chamber;

a third chamber at least partially defined by the outer wal l, wherein the third chamber is further from the axis of rotation than the first chamber; and

a tubing path that holds a portion of tubing that fluidly con nects a first container positioned in the first chamber to a second container positioned in the second chamber, wherein a distance between the axis of rotation and the tubing path varies from a first location of the tubing path to a second location of the tubing path.

25. The system box of claim 24, wherein the first location of the tubing path is near the third chamber.

26. The system box of claim 24 or claim 25, wherein the second location of the tubing path is near the second chamber.

27. The system box of any of the preceding claims, wherein a portion of the tubing path comprises a ledge.

28. The system box of any of the preceding claims, wherein at least a portion of the tubing path is along an inside surface of the outer wall.

29. The system box of any of the preceding claims, wherein the tubing path further comprises a tubing guide that maintains tubing in the tubing path.

30. The system box of claim 29, wherein the tubing guide comprises a pair of opposing tabs that prevent tubing from moving out of the path.

31. The system box of any one of the preceding claims, wherein the tubing path fu rther comprises a second tu bing guide.

32. The system box of claim 31, wherein the second tubing guide comprises a second pair of opposing tabs that prevent tubing from moving out of the path.

33. The system box of any one of the preceding claims, further comprising an inlet holder positioned adjacent the second chamber.

34. The system box of claim 33, wherein the inlet holder comprises a channel configured to hold an in let for the second container of the container system.

35. A method of separating components from a volu me of composite fluid, the method comprising:

loading a bag system onto a system box, the loading comprising:

positioning a first bag of a bag system into a first chamber of the system box, wherein the first bag comprises a volu me of composite fluid;

routing a portion of tubing that connects the first bag to the second bag along a tubing path, wherein the tubing path has a varying radius with respect to an axis of rotation, so that a first point in the tubing path has a larger radius than a second point along the tubing path;

positioning a second bag of the bag system into a second chamber of the system box;

positioning an inlet of the second bag of the bag system in an inlet holder;

separating the composite fluid into a plu rality of components; and

unloading the bag system from the system box, wherein at least one of the plurality of components is stored in the second bag and the unloading comprises:

removing the inlet from the inlet holder; and

removing the portion of tubing from the tu bing path.

36. The method of claim 35, wherein the composite fluid is blood, and the at least one of the plu rality of components comprises one or more of plasma, platelets, white blood cel ls, red blood cells and combinations thereof.

37. The method of claim 35 or claim 36, wherein the composite fluid is blood, and the at least one of the plurality of components comprises plasma.

38. The method of any one of the preceding claims, wherein the separating comprises subjecting the composite fluid and bag system to a centrifugal field.

39. The method of any one of the preceding claims, further comprising positioning a third bag of the bag system into a third chamber of the system box, wherein the third bag comprises a volume of solution.

40. The method of any one of the preceding claims, further comprising breaking a frangible to allow fluid communication between the third bag and the first bag, wherein the frangible is on the system box.

41. A system box for holding a container system, the system box comprising: a first chamber comprising a first opening;

a second chamber comprising a second opening; and

a tubing holder adjacent the first chamber, the tubing holder comprising a proximal end, a distal end, and a side wall defining an interior volume of the tubing holder, wherein at the proximal end, the sidewall flares outwardly away from the interior volume.

42. The system box of claim 41, further comprising:

at least one outer wall that partially defines the second chamber.

43. The system box of claim 41 or claim 42, wherein the least one outer wall is curved.

44. The system box of any one of the preceding claims, wherein at least a portion of the second chamber is between the first chamber and the outer wall.

45. The system box of any one of the preceding claims, fu rther comprising: a third chamber, wherein at least a portion of the third chamber is between the first chamber and the outer wal l.

46. A system box for holding a container system, the system box comprising: a first chamber; a second chamber at least partially defined by an outer wall, wherein the second chamber is further from the axis of rotation than the first chamber; a third chamber at least partially defined by the outer wal l, wherein the third chamber is further from the axis of rotation than the first chamber; and at least one sensor that senses an adaptor positioned in the first chamber.

47. The system box of claim 46, wherein the sensor determines whether the adaptor is a first adaptor or a second adaptor.

48. The system box of claim 47, wherein the first adaptor has a first weight.

49. The system box of claim 48, wherein the second adaptor has a second weight different from the first weight.

50. The system box of any one of the preceding claims, wherein a weight of the adaptor added to a weight of a container of fluid positioned in the first chamber equals at least a predetermined weight.