Patent Publication Number: US-11648179-B2

Title: Sealer-less plasma bottle and top for same

Description:
RELATED APPLICATION 
     This patent application is a continuation in part of and claims priority from all priority dates of PCT Application number PCT/US17/32824, filed May 16, 2017, entitled “Sealer-Less Plasma Bottle and Top for Same,” and naming Christopher S. McDowell as inventor, the disclosure of which is incorporated herein, in its entirety by reference. 
     PCT Application number PCT/US17/32824 claims priority from U.S. Provisional Application No. 62/337,031, filed May 16, 2016, entitled “Sealer-Less Plasma Bottle and Top for Same,” and naming Christopher S. McDowell as inventor, the disclosure of which is incorporated herein, in its entirety by reference. 
     This patent application also claims priority from U.S. Provisional Application No. 62/674,913, filed May 22, 2018, entitled “Sealer-Less Plasma Bottle and Top for Same,” and naming Christopher S. McDowell and Matthew J. Murphy as inventors, the disclosure of which is incorporated herein, in its entirety by reference. 
    
    
     TECHNICAL FIELD 
     The present invention relates to blood component storage containers, and more particularly plasma storage containers. 
     BACKGROUND ART 
     Blood plasma is a straw-colored liquid component of whole blood, in which blood cells, such as red blood cells and white blood cells, and other components of the whole blood are normally suspended. Whole blood is made up of about 55%, by volume, plasma. Plasma plays important roles in a body&#39;s circulatory system, including transporting blood cells, conducting heat and carrying waste products. Pure plasma contains clotting factors, which increase the rate at which blood clots, making it useful in surgery and in the treatment of hemophilia. Banked whole blood is sometimes used to replace blood lost by patients during surgery or as a result of traumatic injuries. However, if banked whole blood that is compatible with the patient&#39;s blood type is not available, plasma may sometimes be used to replace some of the lost blood. Plasma additionally contains proteins that may be used to produce pharmaceuticals for immunodeficiency and other protein disorders. Furthermore, plasma may be frozen and stored for relatively long periods of time until it is needed. 
     To collect plasma, whole blood may be collected from a donor, and the plasma may be separated from the other components of the donated whole blood later, such as in a laboratory. However, in other cases, the plasma is separated from the other components of the whole blood at the donation site, and the other components are returned to the circulation system of the donor. For example, apheresis is a medical technology in which the blood of a donor or patient is passed through an apparatus, such as a centrifuge, that separates out one particular constituent and returns the remainder to the donor or patient. Plasmapheresis is a medical therapy that involves separating blood plasma from whole blood. 
     Collected plasma for pharmaceutical manufacturing is typically stored in plastic bottles. A typical plasma bottle includes two ports, one for introducing plasma into the bottle, and the other for venting air out of the bottle. Each of the ports typically extends from a surface of the plasma bottle (e.g., the top of the plasma bottle) and may have tubing connected to it. After plasma has been collected in the bottle, the tubing is cut off using radiofrequency sealing tongs, leaving short (typically about 1½ inch long) sealed tubing stubs attached to the ports extending from the plasma bottle. These stubs typically project from the bottle neck and may pose problems during transport and storage. For example, when the plasma is frozen, the plastic of the stubs and/or ports becomes brittle and may break, thereby violating the requirement to keep the plasma in a sealed container. 
     SUMMARY OF THE EMBODIMENTS 
     In a first embodiment of the invention there is provided a top for a plasma storage container. The top includes a top body that defines the structure of the top and seals an opening of the plasma storage container. The top may also include a first opening and a vent opening extending through the top body. A septum may be located at least partially within the first opening, and may include an aperture through it. The septum may allow a blunt cannula to pass through the aperture to access the interior of the plasma storage container. The top may also include a hydrophobic membrane located on underside of the top body. The membrane covers the vent opening and may allow air to move through the vent opening during filling of the plasma storage container while preventing ingress of undesirable microorganisms. 
     In some embodiments, the top may also include a skirt that extends downward from the underside of the top body around the first opening. The septum may be located and secured (e.g., via a swage connection) within the skirt. Alternatively, the septum may be overmolded with the skirt. The skirt and/or the swage connection may apply a compressive retaining force on the aperture. The aperture may be closed when the blunt cannula is not connected, and the first opening may be larger than the vent opening. Additionally or alternatively, the septum may allow a sample collection container holder to pass through the aperture to access the interior of the plasma collection container. For example, the sample collection container holder may be a vacutainer holder. The blunt cannula may be part of a tubing set connected to a blood processing device. 
     The top body may also include at least one flow channel on the underside of the top body. The at least one flow channel may be in fluid communication with the vent opening to allow airflow in and out of the plasma storage container via the vent opening. The surface area of the hydrophobic membrane may be larger than a cross-sectional area of the vent opening, and/or the hydrophobic membrane may be sealed and/or ultrasonically welded to an energy director on the underside of the top body. The top may include a retaining element (e.g., a clip) located on a top surface of the top body. The retainer may hold the blunt cannula in place during filling of the plasma storage container. 
     In accordance with additional embodiments, a plasma storage container includes a container body that defines the structure of the plasma storage container and defines an interior. The container includes a top configured to seal an opening of the plasma storage container. The top may include a first opening and a vent opening extending through the container top. A septum may be located at least partially within the first opening and may include a pre-pierced aperture therethrough. The septum/aperture allows a blunt cannula to pass through the aperture to access the interior of the plasma storage container. The container also includes a hydrophobic membrane located on underside of the container top. The membrane covers the vent opening and allows air to pass through the vent opening during plasma collection. The first opening may be larger than the vent opening. 
     In some embodiments, the plasma storage container may include a skirt that extends from the underside of the container top around the first opening. The septum may be located and secured within the skirt, for example, via a swage connection. Additionally or alternatively, the septum may be overmolded within the skirt. The skirt and/or the swage connection may apply a radially inward force on the aperture that biases the aperture closed. The aperture may be closed when the blunt cannula is not connected. 
     The container top may include at least one flow channel on an underside of the container top. The flow channel(s) may be in fluid communication with the vent opening to allow airflow in and out of the plasma storage container via the vent opening. The surface area of the hydrophobic membrane may be larger than a cross-sectional area of the vent opening. Additionally or alternatively, the hydrophobic membrane may be ultrasonically welded to the underside of the container top and/or may be sealed to the underside of the container top. 
     In further embodiments, the plasma storage container may include a retainer located on a top surface of the container top. The retainer may hold the blunt cannula in place during filling of the plasma storage container, and/or may be a clip. In other embodiments, the septum may allow a sample collection container holder (e.g., a vacutainer holder) to pass through the aperture to access the interior of the plasma collection container. The blunt cannula may be part of a tubing set connected to a blood processing device. 
     In accordance with additional embodiments, a top for a plasma storage container may include a top body that defines the structure of the top and seals an opening of the plasma storage container. The top may also include a first opening and a vent opening extending through the top body. A valve mechanism may be located at least partially within the top body. The valve mechanism may have an aperture therethrough that opens upon connection of a blunt cannula to the plasma storage container (e.g., thereby providing access the interior of the plasma storage container). The top may also have a vent filter that allows air to vent through the vent opening during filling of the plasma storage container. 
     The valve mechanism may include a septum and the aperture may extend through the septum. The aperture may allow the blunt cannula to at least partially enter the aperture after connection of the blunt cannula to the plasma storage container. In some embodiments, the top may include a skirt extending from the underside of the top body and around the first opening. The septum may be located and secured within the skirt (e.g., via swage connection). The skirt and/or the swage connection may apply a radially inward force on the septum to keep the septum secured within the skirt. 
     In further embodiments, the valve mechanism may include a resilient member that has (1) a septum located nearer the top of the resilient member and (2) a valve wall that extends downward from the septum. The aperture may extend through the septum, and the valve wall may form a valve interior. Additionally, the top may include a valve housing that extends from a top surface of the top. The valve mechanism may at least partially be located within valve housing. The valve housing may include an inlet portion. The septum may be located at least partially within the inlet portion, and an inner surface of the inlet portion may include a luer taper. A cap may be placed over at least a portion of the inlet portion, and the cap may provide a sterile barrier for the first opening prior to connection of the blunt cannula. 
     The valve housing may also include a second portion that is located below the inlet portion. The second portion may have an inner diameter that is greater than an inner diameter of the inlet portion. Additionally or alternatively, the second portion may have an inner diameter that expands along a length of the second portion. Connection of the blunt cannula to the plasma storage container may cause the septum to move from the inlet portion of the valve housing to the second portion (e.g., to allow the aperture to open). 
     In still further embodiments, the valve housing may include a locking mechanism that locks the blunt cannula to the valve housing. For example, the locking mechanism may include luer threads. Additionally or alternatively, the blunt cannula may have a skirt and threads within the skirt. The skirt threads may engage the luer threads on the valve housing. The first opening may be larger than the vent opening. 
     The vent filter may include a hydrophobic membrane that is located on the underside of the top body and covers the vent opening. The top body may include at least one flow channel on the underside of the top body. The flow channel(s) may be in fluid communication with the vent opening to allow airflow in and out of the plasma storage container via the vent opening. A surface area of the hydrophobic membrane may be larger than a cross-sectional area of the vent opening, and the hydrophobic membrane may be sealed to the underside of the top body. 
     In other embodiments, the vent filter may include a plug filter. For example, the plug filter may be a self-sealing filter that seals the vent opening upon exposure of the plug filter to liquid. The top may include a vent skirt extending from the top body (e.g., from the underside of the top body) and around the vent opening. The plug filter may be located and secured within the vent skirt. Also, the top may include at least one splash guard extending from the vent skirt. The splash guard may prevent liquid from contacting the plug filter during filling of the plasma storage container. 
     In additional embodiments, the top may include a removable sterile barrier seal that covers the first opening prior to connection of the blunt cannula. On the top surface, the top may include a retainer (e.g., a clip) that holds the blunt cannula in place during filling of the plasma storage container. The blunt cannula may be part of a tubing set connected to a blood processing device. The tubing set may include a connector configured to connect to a blood component separation device and a cap secured to the connector via a tether. The blunt cannula may be secured to the tether prior to use. The cannula may include a grasping element configured to allow a user to grasp the cannula during use. The top may also include at least one stiffening rib located on an underside of the top. 
     In accordance with further embodiments, a top for a plasma storage container includes a top body that defines the structure of the top and seals an opening of the plasma storage container. The top also has an inlet opening extending through the top body and a valve mechanism located at least partially within the inlet opening. The valve mechanism has an aperture that is configured to open upon connection of a cannula to the plasma storage container (e.g., to provide access to the interior of the plasma storage container). A locking mechanism locks the cannula to the top, and the top may have a vent opening extending through the top body. A vent filter allows air to vent through the vent opening during filling of the plasma storage container. 
     The valve mechanism may include and/or be a septum and the top may have a skirt extending from the underside of the top body and around the first opening. The septum may be located and secured within the skirt (e.g., via a swage connection). The skirt and/or the swage connection may apply a radially inward force on the septum to keep the septum secured within the skirt. The aperture may be closed when the blunt cannula is not connected and may allow the cannula to at least partially enter the aperture after connection of the cannula to the plasma storage container. 
     The locking mechanism may include a locking protrusion extending from the top body and into the inlet opening. The locking protrusion may snap into a recess within the cannula during connection of the cannula. The cannula may include a cannula protrusion that extends from a surface of the cannula, and the locking protrusion may snap over the cannula protrusion into the recess during connection of the cannula. At least one surface of the locking protrusion may be angled to allow the locking protrusion to snap over the cannula protrusion. 
     In some embodiments, the top may include a cannula support structure that extends from a top surface of the top and defines a channel configured to support the cannula when connected to the plasma storage container. The cannula support structure may include a camming surface, and rotation of the cannula may cause the cannula to slide up the camming surface. This, in turn, causes the locking protrusion to snap out of the recess and disconnects the cannula from the plasma storage container. 
     To provide a sterile barrier for the inlet opening prior to connection of the cannula, the top may have a cap that connects to the inlet opening. The cap may have a lower portion that extends into the inlet opening when connected to the plasma storage container, and a mating portion that mates with at least a portion of the channel of the cannula support structure. The cannula may have a grasping element that allows a user to grasp the cannula during use and/or the grasping element may include a clamp. 
     The cannula may be part of a tubing set connected to a blood processing device. For example, the tubing set may include a connector configured to connect to a blood component separation device and a cap secured to the connector via a tether. The cannula may be secured to the tether prior to use. 
     In some embodiments, the inlet opening may be larger than the vent opening and/or the vent opening may include a hydrophobic membrane that is located on an underside of the top body and covers the vent opening. The top body may have at least one flow channel on the underside of the top body. The flow channel may be in fluid communication with the vent opening to allow airflow in and out of the plasma storage container via the vent opening. The surface area of the hydrophobic membrane may be larger than a cross-sectional area of the vent opening and/or the hydrophobic membrane may be sealed to the underside of the top body. 
     In other embodiments, the vent filter may include a plug filter. The plug filter may be a self-sealing filter configured to seal the vent opening upon exposure of the plug filter to liquid. In such embodiments, the top may include a vent skirt extending from the top body (e.g., from the underside) around the vent opening. The plug filter may be located and secured within the vent skirt. The top may also have at least one splash guard that extends from the vent skirt. The splash guard may prevent liquid from contacting the plug filter during filling of the plasma storage container. 
     On the top surface, the top may have a retainer (e.g., a clip) that holds the blunt cannula in place during filling of the plasma storage container. The valve mechanism may also allow a sample collection container holder (e.g., a vacutainer holder) to pass through the aperture to access the interior of the plasma collection container. The top may have at least one stiffening rib located on an underside of the top. 
     In some embodiments, the valve mechanism may include a resilient member with (1) a septum located nearer the top of the resilient member and (2) a valve wall that extends downward from the septum. The aperture may extend through the septum, and the valve wall may form a valve interior. The top may have a valve housing that extends from a top surface of the top. The valve mechanism may be located, at least partially, within the valve housing. The valve housing may have an inlet portion and the septum may be located at least partially within the inlet portion. The inner surface of the inlet portion may have a luer taper. 
     The valve housing may also include a second portion located below the inlet portion. The second portion may have an inner diameter that is greater than an inner diameter of the inlet portion and/or the second portion may have an inner diameter that expands along a length of the second portion. Connection of the blunt cannula to the plasma storage container may cause the septum to move from the inlet portion of the valve housing to the second portion to allow the aperture to open. The locking mechanism may be on the valve housing. For example, the locking mechanism may include luer threads. The blunt cannula may have a skirt and threads within the skirt. The threads may engage the luer threads on the valve housing. 
     In accordance with additional embodiments, a plasma storage container has (1) a container body that defines the structure of the plasma storage container and an interior, and (2) a container top that seals an opening of the plasma storage container. The container may also have an inlet opening extending through the top body and a valve mechanism located at least partially within the inlet opening. The valve mechanism may have an aperture that opens upon connection of a cannula to the plasma storage container (e.g., to provide access to the interior of the plasma storage container). The container/top also has (1) a locking mechanism, (2) a vent opening extending through the top body, and (3) a vent filter. The locking mechanism may lock the cannula to the top. The vent filter allows air to vent through the vent opening during filling of the plasma storage container. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing features of embodiments will be more readily understood by reference to the following detailed description, taken with reference to the accompanying drawings, in which: 
         FIG.  1    schematically shows a perspective view of a plasma storage container, in accordance with embodiments of the present invention. 
         FIG.  2    schematically shows a top perspective view of a top, without a septum and hydrophobic membrane installed, for the plasma storage container shown in  FIG.  1   , in accordance with embodiments of the present invention. 
         FIG.  3    schematically shows a bottom perspective view of a top, without a septum and hydrophobic membrane installed, for the plasma storage container shown in  FIG.  1   , in accordance with embodiments of the present invention. 
         FIG.  4    schematically shows a top perspective view of a top, with a septum and hydrophobic membrane installed, for the plasma storage container shown in  FIG.  1   , in accordance with embodiments of the present invention. 
         FIG.  5    schematically shows a bottom perspective view of a top, with a septum and hydrophobic membrane installed, for the plasma storage container shown in  FIG.  1   , in accordance with embodiments of the present invention. 
         FIG.  6    schematically shows a top perspective view of a top, with a blunt cannula inserted into the septum, for the plasma storage container shown in  FIG.  1   , in accordance with embodiments of the present invention. 
         FIG.  7    schematically shows an exemplary blunt cannula for use with the plasma collection container of  FIG.  1   , in accordance with embodiments of the present invention. 
         FIG.  8    schematically shows an exemplary tubing set containing the blunt cannula of  FIG.  7   , in accordance with embodiments of the present invention. 
         FIG.  9    schematically shows an exemplary cap for the tubing set shown in  FIG.  8    with the blunt cannula inserted, in accordance with embodiments of the present invention. 
         FIGS.  10 A and  10 B  schematically show an alternative cap for the tubing set shown in  FIG.  8   , in accordance with additional embodiments of the present invention. 
         FIGS.  11 A to  11 C  schematically show an alternative top for the plasma storage container, in accordance with further embodiments of the present invention. 
         FIGS.  12 A to  12 E  schematically show an additional alternative top for the plasma storage container, in accordance with further embodiments of the present invention. 
         FIGS.  13 A to  13 C  schematically show a further alternative top for the plasma storage container, in accordance with further embodiments of the present invention. 
         FIG.  14    schematically shows the bottom of the alternative top shown in  FIGS.  13 A- 13 C , in accordance with additional embodiments of the present invention. 
         FIG.  15    schematically shows a cross-sectional view of the alternative top shown in  FIGS.  13 A- 13 C , in accordance with additional embodiments of the present invention. 
         FIG.  16    schematically shows a plasma container with the top shown in  FIGS.  13 A-C  and a cannula about to be inserted into the inlet, in accordance with some embodiments of the present invention. 
         FIGS.  17 A to  17 B  schematically show cross-sectional views of a cannula connected to the top shown in  FIGS.  13 A-C , in accordance with further embodiments of the present invention. 
         FIG.  18    schematically shows a cannula connected to the top shown in  FIGS.  13 A-C , in accordance with further embodiments of the present invention. 
         FIG.  19    schematically shows a cannula being disconnected from the top shown in  FIGS.  13 A-C , in accordance with additional embodiments of the present invention. 
         FIG.  20    schematically shows a sterile barrier located on a top, in accordance with some embodiments of the present invention. 
         FIG.  21    schematically shows an alternative sterile barrier, in accordance with additional embodiments of the present invention. 
         FIGS.  22  to  24    schematically show an additional alternative sterile barrier, in accordance with additional embodiments of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS 
       FIG.  1    is a perspective view of a blood plasma container  100 , according to an embodiment of the present invention. The plasma container  100  may have a body portion  110  and a top  120  that closes an opening  130  (e.g., an open end in the body portion  110  at the proximal end  140  of the plasma container  100 ). As discussed in greater detail below, plasma may be collected within the plasma container  100  and sampled through the top  120 . The body portion  110  defines an interior volume  150  (e.g., an interior) in which the collected plasma can be stored. 
     As shown in  FIGS.  2  and  3   , the top  120  includes a vent hole  160  through which air may pass bidirectionally during plasma collection  100 , and an inlet hole  170  through which the plasma may be transferred into the plasma container  100 . The size of the vent hole  160  and the inlet hole  170  may vary depending on the application, but, in some embodiments, the inlet hole  170  may be substantially larger the vent hole  160 . Additionally, the top  120  may include a retainer  180  extending from a top surface  122  of the top. As discussed in greater detail below, the retainer  180  may be used to secure a blunt cannula (which, in turn, is used to transfer plasma into the container  100 ) to the top  120  of the plasma container  100  while plasma is being collected within the container  100 . The retainer  180  may be any number of components capable of securing the blunt cannula (e.g., a standard male luer). For example, the retainer  180  may be clip with two proximally extending protrusions  182 A/B that define a space  184  between them in which the cannula may reside. In such embodiments, the user may push the cannula into the retainer/clip  180  until it snaps/clicks into the space  184 . To hold the cannula in place within the clip  180 , the protrusions  182 A/B may include inward projections  183 A/B that extend over the cannula when it is located within the space  184 . 
     On the underside  124 , the top  120  may include a skirt  190  that extends distally from the top  120  (e.g., downward from the top  120 ) and around the inlet opening  170 . To help maintain the sterility of the container  100  and keep the inlet opening  170  closed when the container is not being filled with plasma (e.g., before and after filling), the top  120  may include a valve mechanism. For example, the top may include a septum  200  located and secured within the skirt  190 . As best shown in  FIGS.  4  and  5   , the septum  200  may have an aperture  210  extending through the body of the septum  200 . The aperture  210  may be normally closed (e.g., closed when in its natural state and not subject to any external pressures) and/or the aperture  210  may be held closed by a radially compressive force applied to the septum  200  by the skirt  190 . For example, the septum  200  may be swaged into the skirt  190 . As is known in the art, when the septum  200  is swaged within the skirt  190 , a portion of the skirt  190  (e.g., the bottom of the skirt) may be compressed into the septum  200 . This creates a compressive force that keeps the septum  200  in the skirt  190 . Additionally or alternatively, the outer diameter of the septum  200  may be larger than the inner diameter of the skirt  190  and the septum  200  may be press-fit into the skirt  190 . This press-fit will create the radially inward force that keeps the aperture  210  closed. 
     It should be noted that, although the aperture  210  is shown as a slit within  FIGS.  4  and  5   , other aperture configurations may be used. For example, the aperture  210  may consist of two slits formed into a cross shape. Alternatively, the aperture  210  can have more than two slits in the shape of a star or asterisk. It is important to note that the aperture  210  (e.g., the one or more slits) may be formed, for example, using traditional cutting means (e.g., razor blade, knife, etc.), piercing with a needle, or ultrasonic cutting methods. Additionally or alternatively, the aperture  210  could also be formed in-mold during or after the injection molding process. 
     To provide a sterile barrier for the vent hole  170 , the top may include a vent filter. For example, also on the underside  124 , the top  120  may include a hydrophobic membrane  230  located under the vent hole  160  such that the hydrophobic membrane  230  may provide a sterile barrier for the vent hole  160 . During filling of the plasma container  100 , the hydrophobic membrane  230  will allow air to pass through the membrane  230  and the vent hole  160  to prevent atmospheric pressure differentials from building up in the container  100 . To help with air flow, the top may also include a number of channels  220  within the surface under the hydrophobic membrane  230 . The channels  220  can extend to the edge of the vent hole  160  and allow air pass through the membrane  230 , for example, even if the membrane  230  is pushed against the underside  124  of the top  120  (e.g., during high-air-flow-rate periods). 
     The hydrophobic membrane  230  may be ultrasonically welded to the top  120  (or otherwise sealed to the top  120 ) to prevent air from leaking past the hydrophobic membrane  230 . To that end, the top  120  may include an energy director  222  for use during the ultrasonic welding process to ensure that the hydrophobic membrane  230  is properly sealed and secured to the underside  124  of the top  120 . Alternatively, the membrane  230  may be secured to the top  120  via other joining methods including, but not limited to, adhesives, hot melt glue, and laser welding. 
     As shown in  FIG.  5   , to maximize the surface area of the hydrophobic membrane  230  and to ensure that the hydrophobic membrane  230  can handle the required flowrate of air in and out of the container  100 , the hydrophobic membrane  230  may be sized such that it is substantially larger than the vent opening/hole  160 . Additionally, to further maximize the use of membrane material, the hydrophobic membrane  230  may be square. 
     It should be noted that the top  120  and container body  110  may be formed as two separate pieces and then secured together via ultrasonically welded together. To help facilitate the ultrasonic welding, the top  120  may include a distally extending wall  126  that extends over the top of the container body  110  when the top  120  is placed on the body  110  (e.g., over the proximal end  140  of the body  110 ). Additionally, on the underside  124 , the top  120  may include an energy director  128  to aid in the ultrasonic welding process (e.g., to secure the top  120  to the body  110 ). 
     During use and plasma collection, the user may connect the plasma container  100  to a blood processing device via the blunt cannula  240  ( FIG.  7   ) and a tubing set  300  ( FIG.  8   ) on which the blunt cannula  240  may be located. For example, the user may connect the blood processing device connector  310  at one end of the tubing set  300  to the blood processing device (not shown), and the blunt cannula  240  on the other end of the tubing set  300  to the plasma container  100 . To connect the blunt cannula  240  to the plasma container  100 , the user may insert the outlet portion  242  of the cannula  240  into the septum  200  and through the aperture  220 . This will allow the cannula  240  to access the interior volume  150  of the container  100  and create fluid communication between the interior volume  150  and the tubing set  300  (e.g., and the outlet of the blood processing device). The user may then snap the body  244  of the cannula  240  into the retainer  180  to hold the cannula  240  in place on the top  120  ( FIG.  6   ). 
     As the blood processing device separates the plasma from whole blood and sends the plasma to the storage container  100 , the plasma may flow through the tubing set  300  and into the interior volume  150  of the container  100  via the blunt cannula  240 . As the plasma flows into the container  100 , air will exit the container  100  through the hydrophobic membrane  230  and the vent hole/opening  160 . This, in turn, will prevent pressure from building up within the container  100 . As needed/required by the blood processing device, air may also enter the container  100  through hydrophobic/sterilizing membrane  230  and the vent hole/opening  160 . This, in turn, will prevent vacuum from building up within the container  100 . 
     In order to aid in storage and to ensure that the opening in the outlet portion  242  of the cannula  240  is covered and not exposed to the atmosphere, the tubing set  300  may include a cap  320  that can be used for both the blood processing device connector  310  and the outlet portion  242  of the cannula  240  ( FIG.  9   ). For example, the cap  320  may have an open end  322  that may be placed over the blood processing device connector  310  when not in use. Additionally, the top  324  of the cap  320  may have an opening  326  in which the outlet portion  242  of the cannula  240  may be inserted. In some embodiments, the cap  320  may be tethered to the blood component device connector  310 . 
     Once the plasma has been collected within the container  100 , there may be a need to sample the collected plasma at various times (e.g., after collection, sometime during storage, prior to use). To that end, the user may insert a sample collection container holder (e.g., a vacutainer holder) into the septum  200 /aperture  210  to access the volume of plasma within the container  100 . The user may then turn the container  100  upside down and connect a vacutainer to the holder to begin collecting a sample of plasma within the vacutainer. It should be noted that collecting the plasma sample in this manner provides the most representative sample of the plasma in the container  100  possible and minimizes/eliminates any loss of plasma, where residual plasma might otherwise be lost in sampling means that involve sampling through tubing external to the top  120 . 
     It is important to note that the outlet portion  242  of the cannula  240  need not be located within the cap  320  prior to use and may be located elsewhere. For example, as shown in  FIGS.  10 A and  10 B , the tether  330  that secures the cap  320  to the blood processing device connector  310  may include a cup  332  in which the outlet portion  242  of the cannula  240  may be inserted prior to use. In such embodiments, the outlet portion  242  of the cannula  240  may remain covered even after the user has disconnected the cap  320  and connected the blood processing device connector  310  to the blood processing device. Additionally, after use, the outlet portion  242  of the cannula  240  may be reinserted into the cup  332  even if the connector  310  is still connected to the blood processing device. 
     As also shown in  FIGS.  10 A and  10 B , the cannula  240  may also include a grasping element  246  (e.g., a fin or similar structure) that extends from the body  244  of the cannula  240 . In such embodiments, the grasping element may be used to hold and manipulate the cannula  240  during removal of the cannula  240  from the cap  320  or cup  332  within the tether and during connection of the cannula  240  to the plasma container  100 . The grasping element  246  may be sized to allow the user to grasp (e.g., using their thumb and forefinger) the cannula  240 . 
     Although the embodiments described above use a hydrophobic membrane  230  as the vent filter, other embodiments may utilize different vent filters. For example, as shown in  FIGS.  11 A to  11 C , some embodiments may utilize a plug type filter  410 . In such embodiments, the top  120  may have a vent skirt  420  that extends from (e.g., extends downward from) the underside  124  of the top  120  and in which the plug filter  410  is located. The plug filter  410  may be secured within vent skirt  420  in any number of ways including, but not limited to press-fit or swaged. 
     It should be noted that the plug filter  410  can be any number filter types that allows air to vent through the vent hole  160  and provides a sterile barrier. In some embodiments, the plug filter  410  can be a hydrophobic filter like the membrane  230  discussed above and/or the plug filter  410  can be a Porex™ plug filter. Additionally or alternatively, in other embodiments, the plug filter  410  may be a self-sealing filter (also sold by Porex™) that swells upon contact with a liquid to seal the vent hole  160  and prevent the liquid within the plasma container  100  from leaking out of the vent hole  160 . For example, once the plasma collection process is complete, and the user turns the container  100  upside to collect a sample (discussed above), the plasma will contact plug filter  410  causing it to self-seal and preventing the plasma from leaking out of the vent hole  160 . 
     In some embodiments, particularly those using self-sealing plug filters, it may be beneficial to minimize the risk of fluid (e.g., plasma) contacting the vent filter (e.g., the plug filter  410 ) during filling of the plasma container  100 . To that end, the top  120  may have one or more splash guards  430  that protect the plug filter  410  from any splashing or foaming within the plasma container  100  during filling. For example, as best shown in  FIGS.  11 A- 11 C , the splash guards  430  may extend downward from the bottom of the vent skirt  420 . One or more of the splash guards (e.g., the one closet to the inlet  170 ) may be angled to better prevent any droplets of plasma (or foam) from reaching the plug filter  410 . Also, it should be noted that, although  FIGS.  11 A- 11 C  show two splash guards  430 , other embodiments may have only a single splash guard  430  or more than two splash guards  430 . 
     As best shown in  FIGS.  11 A and  11 B , the underside  124  of the top  120  can have a number of structures that help stiffen the top  120 . For example, the top  120  may include stiffening ribs  440  on the underside  124  of the top  120 . The ribs  440  may be asymmetric and irregular to help prevent nodal vibrations with resonance in the top  120  during the ultrasonic weld process (e.g., to secure the top  120  to the plasma container  100 ). 
       FIGS.  12 A- 12 E  show a top  120  for a plasma storage container  100  with an alternative valve mechanism, for example, a needleless valve. In such embodiments, in addition to the skirt  190  that extends from the underside  124  of the top  120 , the top  120  can include a valve housing  510  that extends upward from the top surface  122  of the top  120 . The valve housing  510  may form an interior  512  in which the valve mechanism may be located and may have an inlet portion  514  with an internal geometry that complies with a standard luer taper (e.g., the internal diameter of the inlet portion  514  may be tapered to comply with luer standards). The inlet  170  may be located at the proximal end of the inlet portion  514  such that upon connection of the cannula  240 , a portion of the cannula  240  will enter the inlet portion  514  of the valve housing  510 . 
     Located below the inlet portion  514 , the valve housing  510  may include a second/distal portion  516  that has a larger inner diameter than that of the inlet portion  514 . It is important to note that the larger inner diameter may expand gradually like that shown in  FIGS.  12 A to  12 E  or the increase in diameter may happen in a single step (e.g., the diameter does not gradually expand from the inner diameter of the inlet portion  514  to the inner diameter of the second/distal portion  516 ). As discussed in greater detail below, the increased diameter portion  516  helps the aperture  210  within the valve mechanism open during operation. 
     The valve member may be an elastomeric element  520  that include a proximal portion  522  (e.g., a septum) and a valve wall  524  that extends distally from the proximal portion  522  within the inlet housing  510 . The valve wall  524  forms a valve interior  526 , and the valve member  520  also has a distal end  521  that preferably is open (e.g., to allow fluid flow though the valve member  520  and into the plasma container  100 ). To help support the valve member  520  within the inlet housing  510  and skirt  190 , the valve member  520  may include a flange  527  that extends radially outward from the distal portion  521  of the valve member  520  and contacts a shelf portion  192  of the skirt  190 . Like the embodiments described above, the valve member/elastomeric element  520  may be secured within the top  120  via a swage connection (or similar connection). To further support the valve member/elastomeric member  520  within the inlet housing  510  and help position the proximal portion  522  at the inlet  170 , the valve member/elastomeric member  520  have a shoulder  523  that contacts an inner surface of the inlet housing  510  (e.g., the angled/gradually expending diameter of the second/distal portion  516 ) when the valve mechanism is in the closed mode (e.g., when the cannula  240  is not connected). 
     During operation (e.g., during connection of the cannula  240 ), the user may insert the cannula  240 , which may also have a luer taper on the outlet portion  242 , into the inlet  170 . As the cannula  240  is inserted, the valve member  520 , which normally closes/seals the inlet  170 , moves/deforms distally within the inlet housing  510 . As the valve member  520  continues to move/deform distally into the inlet housing  510 , the aperture  210  will open (e.g., when the proximal portion  522  enters the larger inner diameter portion of the inlet housing  510 ) to create fluid communication between the cannula  240  and the valve interior  526  (and interior of the plasma container  110 ). Conversely, when the cannula  240  is withdrawn from the inlet  170  (e.g., after collection is complete), the elastomeric properties of the valve member  520  cause the valve member  520  to begin to move proximally within the inlet housing  510  and return to its at-rest position with the inlet portion  514 . This, in turn, causes the aperture  210  to close. 
     It should be noted that, in some embodiments, the cannula  240  (e.g., the outlet portion  242  of the cannula  240 ) does not enter (or only partially enters) the aperture  210 . Rather, as shown in  FIG.  12 E , the outlet portion  242  of the cannula  240  may be sized such that it is relatively large as compared to the size of the aperture  210 . In such embodiments, the outlet portion  242  of the cannula  240  will merely contact the top surface of the proximal portion  522  of the valve member and will not enter the aperture  210 . 
     As noted above, some embodiments may have a retainer/clip  180  that secures the cannula  240  to the plasma container  100  and keeps the cannula  240  from accidentally disconnecting from the inlet  170  during use. Additionally or alternatively, as shown in  FIGS.  12 A-E , the outside surface of the inlet housing  510  may also have inlet threads  515  (e.g., luer lock threads) for connecting the cannula  240  and locking the cannula  240  in place. To that end, the cannula  240  may include a skirt  241  with internal threads  243  (e.g., on an internal surface of the skirt  241 ) ( FIG.  12 E ) that engage with the threads  515  on the inlet housing  510 . The inlet threads  510  and the threads  243  within the cannula skirt  241  may comply with ANSI/ISO standards (e.g., they are able to receive/connect to medical instruments complying with ANSI/ISO standards). 
     It is important to note that although luer lock threads are discussed above, other embodiments may use other connections such as a BNC connection. For example some embodiments, may utilize connections that lock with only a partial turn. Such connections may include radial protrusions (on the inlet housing  510  or the cannula  240 ) that mate with a ramped surface (e.g., on the inlet housing  510  or cannula). 
       FIGS.  13 A- 13 C  show a top for a plasma storage container with a different mechanism to connect the cannula  240  to the inlet  170  of the top  120 . Like the top  120  described above and shown in  FIGS.  4  and  5   , the top shown in  FIGS.  13 A- 13 C  may include a septum  200  (e.g., a valve mechanism) that is located and secured within a skirt  190  extending from the underside of the top  120 . The septum  200  may be swaged within the skirt  190  and may have an aperture  210  (e.g., a normally closed aperture) that extends through it to allow the cannula  240  to access the interior of the container  100  upon connection. As discussed above, the aperture  210  may be one or more slits that extend through the septum  200  or, as shown in  FIG.  14   , may be a pre-pierced hole that opens under elastic deformation when the cannula  240  is connected. 
     To help with the connection and disconnection of the cannula  240 , the top  120  may have cannula support structure  710  that extends from the top surface  122  of the top  120  and around the inlet  170 . The cannula support structure  710  may be cup/u-shaped such that the wall  712  of the structure  710  slopes downward to create a channel  714  within support structure  710 . As discussed in greater detail below, the cannula  240  may reside within the channel  714  after connection to inlet  170  and the cannula support structure  710  (e.g., the top surface  716  of the structure) may act as a camming surface to help the user disconnect the cannula  240  from the top  120 . 
     Within the interior of the inlet  170 , the top  120  may have an inwardly projecting protrusion  720  (e.g., an inlet protrusion) that extends from the inner surface of the inlet  170  ( FIG.  15   ). During connection of the cannula  240 , the protrusion  720  may interact with a protrusion  810  on the cannula  240  ( FIG.  16   ) to secure the cannula  240  in place. For example, as the user connects the cannula  240  (e.g., by inserting the cannula  240  into the inlet  170 ), the protrusion  810  on the cannula  240  will contact the inlet protrusion  720 . As the user applies additional pressure, the cannula protrusion  810  will snap over the inlet protrusion  720  such that the inlet protrusion  720  resides within a recess  820  on the cannula  240  ( FIG.  17 A / 17 B). At this point, the cannula  240  is fully connected as shown in  FIG.  18    and the aperture  210  within the septum  200  is open to allow fluid (e.g., plasma to be collected within the container  100 ). Additionally, because of the interaction between the cannula protrusion  810  and the inlet protrusion  720 , the cannula  240  may not be inadvertently disconnected from container  100  (e.g., by accidental bumping, etc.). 
     Although  FIGS.  15  and  17 A /B show the inlet protrusion  720  as extending around the entire circumference of the inlet opening  170 , in other embodiments, the protrusion  720  may only extend around a portion of the inlet opening  170 . Additionally or alternatively, some embodiments may include more than one inlet protrusion  720  (e.g. two or more) that are spaced about the diameter of the inlet opening  170 . Similarly the cannula protrusion  810  and recess  820  may not extend around the entire circumference of the cannula  240 . In such embodiments, the protrusion  810  and recess  820  may only extend around a portion of the circumference and/or there may be more than one protrusion  810  and recess  820  that are spaced about the circumference of the cannula  240 . 
     It should be noted that the cannula protrusion  810  and/or the inlet protrusion  720  may have features that reduce the force required to connect the cannula  240  and snap the inlet protrusion  720  over the cannula protrusion  810  and into the recess  820 . For example, the surface  722  of the inlet protrusion  720  that contacts the cannula protrusion  810  and/or the surface  812  of the cannula protrusion  810  that contacts the inlet protrusion  720  may be angled to allow the protrusions to more easily pass over one another. 
     As noted above, the top surface  716  of the cannula support structure  710  may act as a camming surface that helps to disconnect the cannula  240  after fluid collection is complete. To that end, once the fluid collection is complete and the user wishes to disconnect the cannula  240 , the user may grab the cannula  240  (e.g., via the body  240  and/or the grasping element  246 ) and turn the cannula  240  (e.g., clockwise or counter-clockwise) ( FIG.  19   ). As the user turns the cannula  240 , the cannula  240  will begin to slide up the top surface  716  of the support structure  710 , causing the inlet protrusion  720  to snap over the cannula protrusion  810  to disconnect the cannula  240  from the inlet  170 . 
     During processing the user/technician may need to occlude the various tubing/tubes within the collection system (e.g. the tube within the tubing set  300  or other tubing used during collection). To that end, some embodiments may incorporate an additional clamp within the set. For example, as shown in  FIGS.  16 ,  18  and  19   , the grasping element  246  may be formed with a tubing clamp  248 . In use, if the technician wishes to occlude a section of tube, the technician may slide the tube into the tubing clamp  248  which will, in turn, deform and close the tube to prevent fluid from flowing through the tube. 
     It is important to note that, in some applications, it may be beneficial to keep the inlet  170  sealed and/or sterile prior to use and connection of the cannula  240 . To that end, some embodiments may include a sterile barrier that may be placed over the inlet  170 . For example, as shown in  FIG.  20   , the top  120  may include a sterile barrier  610  (e.g., a removable label) that may be secured to the top surface  122 . The sterile barrier  610  may be secured to the top in any number of ways including, but not limited to, adhesive, welding, and bonding. To help with removal of the sterile barrier  610 , the sterile barrier  610  may include a pull tab  612  that the user may grab and pull to peel the barrier  610  off of the inlet  170 . In embodiments that include the valve housing  510 , the top  120  may alternatively include a removable cap/cover  620  ( FIG.  21   ) located over the valve housing  510  (e.g., over the inlet portion  514 ). Like the skirt  241  of the cannula  240 , the inside of the cap/cover  620  may include threads (not shown) that screw onto the threads on the inlet portion  514 . 
     For embodiments like that shown in  FIGS.  13 A- 13 C , the cap  900  may have a lower portion  910  that extends into the inlet  170  when connected to the plasma container  100  to close the inlet and maintain the sterility (see  FIGS.  22 - 24   ). The lower portion  910  that extends into the inlet  170  may have a protrusion that interacts with the inlet protrusion  720  in a manner similar to the cannula protrusion and/or the lower portion  910  may be sized such that it is press-fit into the inlet  170 . On either side of the cap  900  (or both sides of the cap  900 ), the cap  900  may include a mating portion  930  that rests within/mates with the channel  714  within support structure  710 . To remove the cap  900 , in a manner similar to the cannula  240 , the user may grab and turn the cap  900  to cause the mating portion  930  to slide up the top surface  716  (e.g., the camming surface) of the support structure  710 , causing the cap  900  to disconnect from the inlet  170 . Alternatively, the user may simply grab the cap  900  and pull the cap  900  out of the inlet  170 . To make it easier for the user to grab the cap  900  during removal, the top of the cap  900  may have a flange  920  that extends from the cap  900 . 
     Although the embodiments described above eliminate both the port for introducing plasma into prior art containers and the port for venting prior art containers (e.g., the ports extending from the plasma container and the sections of tubing connected to the ports, discussed above), some embodiments may eliminate only a single port (e.g., the container may retain one port). For example, some embodiments may utilize the inlet hole  170  and valve member/septum  200  but retain the vent port (e.g., a vent port extending from the plasma container and having a section of tubing connected to it). Alternatively, some embodiments may utilize the vent hole  160  and hydrophobic membrane  230  (or plug filter  410 ) but retain the port to introduce plasma into the bottle (e.g., an inlet port extending from the plasma container and having a section of tubing extending from it). 
     It should be noted that various embodiments of the present invention provide numerous advantages over prior art plasma storage containers. For example, because embodiments of the present invention eliminate one or more of the plastic stubs and ports mentioned above, some embodiments of the present invention are able to reduce and/or eliminate the risk of breaking and comprising product sterility. Furthermore, various embodiments of the present invention are able to eliminate the need for heat/RF sealing equipment and processes for sealing tubing prior to transportation and storage. Additionally, because embodiments of the present invention allow for sample collection directly via the septum  200  (e.g., as opposed to drawing plasma into a section of tubing first like in many prior art systems), the present invention is able to collect a highly representative sample of the plasma with little/no loss. 
     The embodiments of the invention described above are intended to be merely exemplary; numerous variations and modifications will be apparent to those skilled in the art. All such variations and modifications are intended to be within the scope of the present invention as defined in any appended claims.