Plasma bottles without seals and their caps

Abstract

The top cover for the plasma storage container includes a top cover body, which defines the structure of the top cover and seals the opening of the plasma storage container. The top cover also includes a first opening and an exhaust port extending through the top cover body. The valve mechanism is at least partially located in the top cover body and includes an orifice passing therethrough. The orifice opens when the blunt cannula is connected to provide access to the interior of the plasma storage container. The top cover also includes an exhaust filter. The exhaust filter allows air to be discharged through the exhaust port during the plasma collection process.

Description

[0001] Related Applications

[0002] This PCT patent application claims priority to U.S. Application No. 16 / 161,482, filed on October 16, 2018, entitled “Sealer-Less Plasma Bottle and Top for Same,” having attorney docket number 130670-08102, designating inventors Christopher S. McDowell and Matthew J. Murphy, the disclosure of which is incorporated herein by reference in its entirety.

[0003] This PCT patent application and U.S. patent application No. 16 / 161,482 claim priority to U.S. Provisional Patent Application No. 62 / 674,913, filed on May 22, 2018, entitled “Sealer-Less Plasma Bottle and Top for Same,” having attorney docket number 1611 / C89, designating inventors Christopher S. McDowell and Matthew J. Murphy, the disclosure of which is incorporated herein by reference in its entirety.

[0004] U.S. Patent Application No. 16 / 161,482 is also a continuation-in-part of and claims priority to all priority dates of PCT Application No. PCT / US2017 / 032824, filed on May 16, 2017, entitled “Sealer-Less Plasma Bottle and Top for Same,” (attorney docket number 1611 / C81WO, designating inventor Christopher S. McDowell, the entire contents of which are incorporated herein by reference).

[0005] PCT Application No. PCT / US2017 / 032824 claims priority to U.S. Provisional Application No. 62 / 337,031, filed on May 16, 2016, entitled “Sealer-Less Plasma Bottle and Top for Same,” having Attorney Docket No. 1611 / C68, designating inventor Christopher S. McDowell, the entire contents of which are incorporated herein by reference. Technical Field

[0006] The present invention relates to a blood component storage container, and more particularly to a plasma storage container. Background Art

[0007] Plasma is the straw-colored liquid component of whole blood in which blood cells, such as red and white blood cells, and other whole blood components are normally suspended. Whole blood is about 55% plasma by volume. Plasma plays important roles in the body's circulatory system, including transporting blood cells, conducting heat, and carrying away 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 a patient during surgery or due to trauma. However, if banked whole blood that is compatible with the patient's blood type is not available, plasma can sometimes be used to replace some of the lost blood. Plasma also contains proteins, which are used in the production of drugs for immune deficiencies and other protein diseases. In addition, plasma can be frozen and stored for relatively long periods of time before it is needed.

[0008] To collect plasma, whole blood can be collected from a donor, and the plasma can be separated from other components of the donated whole blood later, such as in a laboratory. However, in other cases, plasma is separated from other components of whole blood at the donation site, and the other components are returned to the donor's circulatory system. For example, apheresis is a medical technique in which a donor's or patient's blood is passed through a device, such as a centrifuge, which separates out a specific component and returns the remaining blood to the donor or patient. Plasmapheresis is a medical treatment that involves separating plasma from whole blood.

[0009] Collected plasma for pharmaceutical production is typically stored in plastic bottles. A typical plasma bottle includes two ports, one for introducing plasma into the bottle and the other for exhausting air from the bottle. Each port typically extends from a surface of the plasma bottle (e.g., the top cap of the plasma bottle) and may have a tube connected to it. After the plasma is collected into the bottle, the tubing is cut using radio frequency sealing pliers, and a short (usually about 1-1 / 2 inches long) stub of sealed tubing is attached to the port extending from the plasma bottle. These stubs typically protrude from the bottleneck and can cause problems during transportation and storage. For example, when the plasma is frozen, the plastic of the stub and / or port becomes brittle and may crack, thereby violating the requirement to keep the plasma in a sealed container. Summary of the invention

[0010] In a first embodiment of the present invention, a top cover for a plasma storage container is provided. The top cover includes a top cover body that defines the structure of the top cover and seals the opening of the plasma storage container. The top cover may also include a first opening and an exhaust port extending through the top cover body. The diaphragm may be at least partially located within the first opening and may include an orifice therethrough. The diaphragm may allow a blunt cannula to pass through the orifice to obtain access to the interior of the plasma storage container. The top cover may also include a hydrophobic membrane located on the underside of the top cover body. The membrane covers the exhaust port and may allow air to move through the exhaust port during the process of filling the plasma storage container while preventing the entry of harmful microorganisms.

[0011] In some embodiments, the top cover may also include a skirt that extends downward from the underside of the top cover body around the first opening. The diaphragm may be located and fixed in the skirt (e.g., by a swaged connector). Alternatively, the diaphragm may be overmolded with the skirt. The skirt and / or swaged connector may apply a compressive retaining force on the orifice. When the blunt cannula is not connected, the orifice may be closed and the first opening may be larger than the exhaust port. Additionally or alternatively, the diaphragm may allow a sample collection container holder to pass through the orifice to obtain access to the interior of the plasma collection container. For example, the sample collection container holder may be a vacuum container holder. The blunt cannula may be part of a tubing kit connected to the blood processing device.

[0012] The top cover body may also include at least one flow channel on the underside of the top cover body. The at least one flow channel may be in fluid communication with the vent to allow air to flow into and out of the plasma storage container via the vent. The surface area of ​​the hydrophobic membrane may be greater than the cross-sectional area of ​​the vent, and / or the hydrophobic membrane may be sealed and / or ultrasonically welded to the energy director on the underside of the top cover body. The top cover may include a retaining element (e.g., a clamp) located on the top surface of the top cover body. During filling of the plasma storage container, the retainer may hold the blunt cannula in place.

[0013] According to 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 cover that is configured to seal the opening of the plasma storage container. The top cover may include a first opening and an exhaust port extending through the container top cover. The diaphragm may be at least partially located within the first opening and may include a pre-punctured orifice therethrough. The diaphragm / orifice allows a blunt cannula to pass through the orifice to obtain access to the interior of the plasma storage container. The container also includes a hydrophobic membrane located on the underside of the container top cover. The membrane covers the exhaust port and allows air to pass through the exhaust port during plasma collection. The first opening may be larger than the exhaust port.

[0014] In some embodiments, the plasma storage container may include a skirt extending from the underside of the container top cover around the first opening. The diaphragm may be positioned and secured within the skirt, for example, by a swaged connector. Additionally or alternatively, the diaphragm may be overmolded within the skirt. The skirt and / or swaged connector may exert a radially inward force on the orifice that biases inwardly to close the orifice. The orifice may be closed when the blunt cannula is not connected.

[0015] The container cover can include at least one flow channel on the underside of the container cover. The flow channel can be in fluid communication with the vent to allow air to flow into and out of the plasma storage container via the vent. The surface area of ​​the hydrophobic membrane can be greater than the cross-sectional area of ​​the vent. Additionally or alternatively, the hydrophobic membrane can be ultrasonically welded to the underside of the container cover and / or can be sealed to the underside of the container cover.

[0016] In additional embodiments, the plasma storage container may include a retainer located on the top surface of the container cap. The retainer may hold the blunt cannula in place during filling of the plasma storage container and / or may be a clamp. In other embodiments, the septum may allow a sample collection container holder (e.g., a vacuum container holder) to pass through the aperture to gain access to the interior of the plasma collection container. The blunt cannula may be part of a tubing kit connected to a blood processing device.

[0017] According to additional embodiments, a top cover for a plasma storage container may include a top cover body that defines the structure of the top cover and seals the opening of the plasma storage container. The top cover may also include a first opening and an exhaust port extending through the top cover body. The valve mechanism may be at least partially located within the top cover body. The valve mechanism may have an orifice therethrough that opens when the blunt cannula is connected to the plasma storage container (e.g., thereby providing access to the interior of the plasma storage container). The top cover may also have an exhaust filter that allows air to be exhausted through the exhaust port during the process of filling the plasma storage container.

[0018] The valve mechanism may include a diaphragm, and the orifice may extend through the diaphragm. After the blunt cannula is connected to the plasma storage container, the orifice may allow the blunt cannula to at least partially enter the orifice. In some embodiments, the top cover may include a skirt extending from the underside of the top cover body around the first opening. The diaphragm may be located and fixed in the skirt (e.g., by a swaged connector). The skirt and / or swaged connector may exert a radially inward force on the diaphragm to retain the diaphragm in the skirt.

[0019] In additional embodiments, the valve mechanism may include a resilient member having (1) a diaphragm located near the top of the resilient member and (2) a valve wall extending downwardly from the diaphragm. The orifice may extend through the diaphragm and the valve wall may form a valve interior. Additionally, the top cover may include a valve housing extending from a top surface of the top cover. The valve mechanism may be at least partially located within the valve housing. The valve housing may include an inlet portion. The diaphragm may be at least partially located within the inlet portion, and an inner surface of the inlet portion may include a Luer taper. An end cap may be placed over at least a portion of the inlet portion, and the end cap may provide a sterile barrier to the first opening prior to connection of the blunt cannula.

[0020] The valve housing may further include a second portion located below the inlet portion. The second portion may have an inner diameter greater than the inner diameter of the inlet portion. Additionally or alternatively, the second portion may have an inner diameter that expands along the length of the second portion. Connection of the blunt cannula to the plasma storage container may cause the diaphragm to move from the inlet portion of the valve housing to the second portion (e.g., to allow the orifice to open).

[0021] In additional embodiments, the valve housing may include a locking mechanism to lock 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 Luer threads on the valve housing. The first opening may be larger than the exhaust port.

[0022] The vent filter may include a hydrophobic membrane located on the underside of the top cover body and covering the vent. The top cover body may include at least one flow channel on the underside of the top cover body. The flow channel may be in fluid communication with the vent to allow air to flow into and out of the plasma storage container via the vent. The surface area of ​​the hydrophobic membrane may be greater than the cross-sectional area of ​​the vent, and the hydrophobic membrane may be sealed to the underside of the top cover body.

[0023] 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 when the plug filter is exposed to liquid. The top cover may include an exhaust skirt extending from the top cover body (e.g., from the underside of the top cover body) and extending around the vent. The plug filter may be positioned and secured within the exhaust skirt. Moreover, the top cover may include at least one splash guard extending from the exhaust skirt. The splash guard may prevent liquid from contacting the filter element during filling of the plasma storage container.

[0024] In an additional embodiment, the top cover may include a removable sterile barrier seal that covers the first opening before the blunt cannula is connected. On the top surface, the top cover may include a retainer (e.g., a clamp) that holds the blunt cannula in place during filling of the plasma storage container. The blunt cannula may be part of a tubing kit connected to a blood processing device. The tubing kit may include a connector configured to be connected to a blood component separation device and an end cap secured to the connector via a tether. The blunt cannula may be secured to the tether before use. The cannula may include a gripping element configured to allow a user to grip the cannula during use. The top cover may also include at least one reinforcing rib on the underside of the top cover.

[0025] According to an additional embodiment, a top cover for a plasma storage container includes a top cover body that defines the structure of the top cover and seals the opening of the plasma storage container. The top cover also has an inlet opening extending through the top cover body and a valve mechanism at least partially located within the inlet opening. The valve mechanism has an orifice that is configured to open when a cannula is connected 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 cover, and the top cover may have an exhaust port extending through the top cover body. An exhaust filter allows air to be exhausted through the exhaust port during filling of the plasma storage container.

[0026] The valve mechanism may include and / or be a diaphragm, and the top cover may have a skirt extending from the underside of the top cover body around the first opening. The diaphragm may be located and fixed in the skirt (e.g., by a swaged connector). The skirt and / or swaged connector may exert a radially inward force on the diaphragm to retain the diaphragm in the skirt. The orifice may be closed when the blunt cannula is not connected, and may allow the cannula to at least partially enter the orifice after the cannula is connected to the plasma storage container.

[0027] The locking mechanism may include a locking projection extending from the top cover body into the inlet opening. During cannula connection, the locking projection may snap into a recess in the cannula. The cannula may include a cannula projection extending from a surface of the cannula, and during cannula connection, the locking projection may snap into the recess on the cannula projection. At least one surface of the locking projection may be angled to allow the locking projection to snap onto the cannula projection.

[0028] In some embodiments, the top cover may include a cannula support structure extending from a top surface of the top cover and defining a channel configured to support the cannula when connected to the plasma storage container. The cannula support structure may include a cam surface, and rotation of the cannula may cause the cannula to slide onto the cam surface. This in turn causes the locking protrusion to disengage from the recess and disconnect the cannula from the plasma storage container.

[0029] To provide a sterile barrier for the inlet opening prior to connecting the cannula, the top cover may have an end cap connected to the inlet opening. The end 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 gripping element that allows a user to grip the cannula during use and / or the gripping element may include a clamp.

[0030] The cannula can be part of a tubing set connected to a blood processing device. For example, the tubing set can include a connector configured to be connected to a blood component separation device and an end cap secured to the connector via a tether. The cannula can be secured to the tether before use.

[0031] In some embodiments, the inlet opening may be larger than the vent and / or the vent may include a hydrophobic membrane that is located on the underside of the top cover body and covers the vent. The top cover body may have at least one flow channel on the underside of the top cover body. The flow channel may be in fluid communication with the vent to allow air to flow into and out of the plasma storage container via the vent. The surface area of ​​the hydrophobic membrane may be larger than the cross-sectional area of ​​the vent, and / or the hydrophobic membrane may be sealed to the underside of the top cover body.

[0032] In other embodiments, the exhaust filter may include a plug filter. The plug filter may be a self-sealing filter configured to seal the exhaust port when the plug filter is exposed to liquid. In such embodiments, the top cover may include an exhaust skirt extending from the top cover body (e.g., from the underside) around the exhaust port. The plug filter may be positioned and secured within the exhaust skirt. The top cover may also have at least one splash guard extending from the exhaust skirt. The splash guard may prevent liquid from contacting the filter element during filling of the plasma storage container.

[0033] On the top surface, the top cover may have a retainer (e.g., a clamp) 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 vacuum container holder) to pass through the aperture to gain access to the interior of the plasma collection container. The top cover may have at least one reinforcing rib located on the underside of the top cover.

[0034] In some embodiments, the valve mechanism may include a resilient member having (1) a diaphragm located near the top of the resilient member and (2) a valve wall extending downward from the diaphragm. The orifice may extend through the diaphragm and the valve wall may form a valve interior. The top cover may have a valve housing extending from a top surface of the top cover. The valve mechanism may be at least partially located within the valve housing. The valve housing may have an inlet portion, and the diaphragm may be at least partially located within the inlet portion. The inner surface of the inlet portion may have a Luer taper.

[0035] The valve housing may also include a second portion located below the inlet portion. The inner diameter of the second portion may be greater than the inner diameter of the inlet portion and / or the inner diameter of the second portion may extend along the length of the second portion. Connection of the blunt cannula to the plasma storage container may cause the diaphragm to move from the inlet portion of the valve housing to the second portion, thereby allowing the orifice 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 Luer threads on the valve housing.

[0036] According to additional embodiments, a plasma storage container has (1) a container body that defines the structure and interior of the plasma storage container, and (2) a container top cover that seals an opening of the plasma storage container. The container may also have an inlet opening extending through the top cover body and a valve mechanism at least partially located within the inlet opening. The valve mechanism may have an orifice that opens when a cannula is connected to the plasma storage container (e.g., to provide access to the interior of the plasma storage container). The container / top cover also has (1) a locking mechanism, (2) an exhaust port extending through the top cover body, and (3) an exhaust filter. The locking mechanism can lock the cannula to the top cover. The exhaust filter allows air to be exhausted through the exhaust port during filling of the plasma storage container. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] The foregoing features of the embodiments will be more readily understood by referring to the following detailed description with reference to the accompanying drawings, in which:

[0038] Figure 1 A perspective view schematically shows a plasma storage container according to an embodiment of the present invention.

[0039] Figure 2 Schematically shows a method for Figure 1 A top perspective view of the top cover of a plasma storage container is shown without the septum and hydrophobic membrane installed.

[0040] Figure 3 Schematically shows a method for Figure 1 A bottom perspective view of the top cover of a plasma storage container is shown without the septum and hydrophobic membrane installed.

[0041] Figure 4 Schematically shows a method for Figure 1 A top perspective view of the top cover of the plasma storage container shown in FIG. 1 with the septum and hydrophobic membrane installed.

[0042] Figure 5 Schematically shows a method for Figure 1 A bottom perspective view of the top cover of the plasma storage container shown in FIG. 1 with the septum and hydrophobic membrane installed.

[0043] Figure 6 Schematically shows an embodiment of the present invention Figure 1 A top perspective view of a cap for a plasma storage container is shown with a blunt cannula inserted into the septum.

[0044] Figure 7 Schematically shows an embodiment of the present invention Figure 1 Exemplary blunt cannula for use with a plasma collection container.

[0045] Figure 8 Schematically shows an embodiment of the present invention including Figure 7 An exemplary tubing kit for a blunt cannula.

[0046] Fig. 9 Schematically shows a method for Figure 8 An exemplary end cap for a tubing set is shown in , with a blunt cannula inserted therein.

[0047] Fig. 10A and 10B Schematically shows a method for Figure 8 Alternative end caps for the tubing kit shown in .

[0048] FIG. 11A to FIG. 11C An alternative cover for a plasma storage container according to an additional embodiment of the present invention is schematically shown.

[0049] FIG. 12A to FIG. 12E Another alternative cover for a plasma storage container according to an additional embodiment of the present invention is schematically illustrated.

[0050] FIG. 13A to FIG. 13C Another alternative cover for a plasma storage container according to other embodiments of the present invention is schematically shown.

[0051] Fig.14 Schematically shows an additional embodiment according to the present invention Figures 13A-13C The bottom of the alternative top cover shown in .

[0052] Fig.15 Schematically shows an additional embodiment according to the present invention Figures 13A-13C A cross-sectional view of an alternative top cover is shown in .

[0053] Fig.16 The plasma container according to some examples of the present invention is schematically shown, and the plasma container has Fig.13A -C shows the top cover and the cannula to be inserted into the inlet opening.

[0054] FIG. 17A to FIG. 17BSchematically shows a connection to an additional embodiment of the present invention. Fig.13A -C is a cross-sectional view of the cannula of the top cover shown.

[0055] Fig.18 Schematically shows a connection to an additional embodiment according to the present invention Fig.13A -C shows the cannula of the top cover.

[0056] Fig.19 Schematically shows an additional embodiment according to the present invention Fig.13A -C shows the cannula with the top cap disconnected.

[0057] Fig. 20 A sterile barrier located on a top cover according to some embodiments of the present invention is schematically shown.

[0058] Fig.21 Alternative sterile barriers according to additional embodiments of the present invention are schematically illustrated.

[0059] Figure 22 to Figure 24 Further alternative sterile barriers according to additional embodiments of the present invention are schematically illustrated. DETAILED DESCRIPTION

[0060] Figure 1 1 is a perspective view of a plasma container 100 according to an embodiment of the present invention. The plasma container 100 can have a body portion 110 and a cover 120 that closes an opening 130 (e.g., an open end in the body portion 110 at a proximal end 140 of the plasma container 100). As discussed in more detail below, plasma can be collected within the plasma container 100 and sampled through the cover 120. The body portion 110 defines an interior space 150 (e.g., an interior) in which collected plasma can be stored.

[0061] like Figure 2 and 3As shown, the top cover 120 includes: a vent hole 160, through which air can pass in both directions during the plasma collection process; and an inlet 170, through which plasma can be transferred into the plasma container 100. The size of the vent hole 160 and the inlet 170 can vary depending on the application, but in some embodiments, the inlet 170 can be substantially larger than the vent hole 160. In addition, the top cover 120 can include a retainer 180 extending from the top surface 122 of the top cover. As discussed in more detail below, when plasma is collected in the container 100, the retainer 180 can be used to secure a blunt cannula (which is subsequently used to transfer plasma into the container 100) to the top cover 120 of the plasma container 100. The retainer 180 can be any number of components capable of securing a blunt cannula (e.g., a standard male Luer connector). For example, the retainer 180 may be clamped with two proximally extending protrusions 182A / B that define a space 184 therebetween in which the cannula may be located. In such an embodiment, the user may push the cannula into the retainer / clamp 180 until it snaps into / snaps into the space 184. To hold the cannula in place within the clamp 180, the protrusions 182A / B may include inward protrusions 183A / B that extend over the cannula when the cannula is located within the space 184.

[0062] On the underside 124, the cap 120 may include a skirt 190 that extends distally from the cap 120 (e.g., downward from the cap 120) and around the inlet 170. To help maintain the sterility of the container 100 and keep the inlet 170 closed when the container is not filled with plasma (e.g., before and after filling), the cap 120 may include a valve mechanism. For example, the cap may include a septum 200 located and secured within the skirt 190. Figure 4 and 5 As best shown, the diaphragm 200 can have an orifice 210 extending through the body of the diaphragm 200. The orifice 210 can be normally closed (e.g., closed when in its natural state and not subject to any external pressure) and / or the orifice 210 can be held closed by a radial compressive force applied to the diaphragm 200 by the skirt 190. For example, the diaphragm 200 can be swaged into the skirt 190. As is known in the art, when the diaphragm 200 is swaged into the skirt 190, a portion of the skirt 190 (e.g., the bottom of the skirt) can be compressed into the diaphragm 200. This creates a compressive force that holds the diaphragm 200 in the skirt 190. Additionally or alternatively, the outer diameter of the diaphragm 200 can be greater than the inner diameter of the skirt 190, and the diaphragm 200 can be press-fit into the skirt 190. Such a press fit will create a radially inward force that holds the orifice 210 closed.

[0063] It should be noted that although Figure 4 and Figure 5 The orifice 210 is shown as a slit, but other orifice configurations may be used. For example, the orifice 210 may include two slits formed in a cross shape. Alternatively, the orifice 210 may have more than two star-shaped or asterisk-shaped slits. It is important to note that the orifice 210 (e.g., one or more slits) may be formed, for example, using a conventional cutting device (e.g., a razor, a knife, etc.), puncturing with a needle, or ultrasonic cutting methods. Additionally or alternatively, the orifice 210 may also be formed in the mold during or after the injection molding process.

[0064] To provide a sterile barrier for the vent 170, the top cover can include a vent filter. For example, also on the underside 124, the top cover 120 can include a hydrophobic membrane 230 located below the vent 160, so that the hydrophobic membrane 230 can provide a sterile barrier for the vent 160. During filling of the plasma container 100, the hydrophobic membrane 230 will allow air to pass through the membrane 230 and the vent 160 to prevent atmospheric pressure differences from accumulating in the container 100. To help air flow, the top cover can also include a plurality of channels 220 in the surface below the hydrophobic membrane 230. The channels 220 can extend to the edge of the vent 160 and, for example, allow air to pass through the membrane 230 even if the membrane 230 is pushed against the underside 124 of the top cover 120 (e.g., during high air flow).

[0065] The hydrophobic membrane 230 may be ultrasonically welded to the top cover 120 (or otherwise sealed to the top cover 120) to prevent air from leaking past the hydrophobic membrane 230. To this end, the top cover 120 may include an energy director 222 used during the ultrasonic welding process to ensure that the hydrophobic membrane 230 is properly sealed and secured to the underside 124 of the top cover 120. Alternatively, the membrane 230 may be secured to the top cover 120 by other bonding methods including, but not limited to, adhesives, hot melt glues, and laser welding.

[0066] like Figure 5 As shown, in order to maximize the surface area of ​​the hydrophobic membrane 230 and ensure that the hydrophobic membrane 230 can handle the required air flow in and out of the container 100, the hydrophobic membrane 230 can be sized so as to be substantially larger than the exhaust port / hole 160. In addition, in order to further maximize the use of membrane material, the hydrophobic membrane 230 can be square.

[0067] It should be noted that the top cover 120 and the container body 110 can be formed as two separate parts and then secured together by ultrasonic welding together. To help facilitate ultrasonic welding, the top cover 120 can include a distally extending wall 126 that extends over the top cover of the container body 110 (e.g., on the proximal end 140 of the body 110) when the top cover 120 is placed on the body 110. Additionally, on the underside 124, the top cover 120 can include an energy director 128 to assist in the ultrasonic welding process (e.g., securing the top cover 120 to the body 110).

[0068] During use and plasma collection, the user can insert the blunt cannula 240 ( Figure 7 ) and a tubing set 300 ( Figure 8 ) to connect the plasma container 100 to the blood processing device. For example, the user can connect the blood processing device connector 310 at one end of the tubing set 300 to the blood processing device (not shown) and connect 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 can insert the outlet portion 242 of the cannula 240 into the septum 200 and through the orifice 220. This will allow the cannula 240 to enter the interior space 150 of the container 100 and establish fluid communication between the interior space 150 and the tubing set 300 (e.g., the outlet of the blood processing device). The user can then snap the body 244 of the cannula 240 into the retainer 180 to hold the cannula 240 in place on the top cover 120 ( Figure 6 ).

[0069] When the blood processing device separates plasma from whole blood and sends the plasma to the storage container 100, the plasma may flow through the tubing set 300 through the blunt cannula 240 and into the interior space 150 of the container 100. When the plasma flows into the container 100, air will leave the container 100 through the hydrophobic membrane 230 and the vent / port 160. This, in turn, will prevent pressure from building up in the container 100. Depending on the needs / requirements of the blood processing device, air may also enter the container 100 through the hydrophobic / sterile membrane 230 and the vent / port 160. This, in turn, will prevent a vacuum from being built up in the container 100.

[0070] To aid in storage and ensure that the opening in the outlet portion 242 of the cannula 240 is covered and not exposed to the atmosphere, the tubing kit 300 may include an end cap 320 that may be used for both the blood processing device connector 310 and the outlet portion 242 of the cannula 240 ( Fig. 9). For example, the end cap 320 can have an open end 322 that can be placed on the blood processing device connector 310 when not in use. In addition, the top 324 of the end cap 320 can have an opening 326 into which the outlet portion 242 of the cannula 240 can be inserted. In some embodiments, the end cap 320 can be constrained to the blood component device connector 310.

[0071] Once plasma has been collected in the container 100, it may be desirable to sample the collected plasma at various times (e.g., after collection, at some time during storage, before use). To this end, the user may insert a sample collection container holder (e.g., a vacuum container holder) into the septum 200 / orifice 210 to gain access to the plasma volume within the container 100. The user may then invert the container 100 and connect the vacuum container to the holder to begin collecting a plasma sample within the vacuum container. It should be noted that collecting a plasma sample in this manner may provide the most representative plasma sample in the container 100 and minimize / eliminate any loss of plasma that may otherwise be lost in a sampling device that samples through an external conduit of the top cover 120.

[0072] It is important to note that the outlet portion 242 of the cannula 240 does not have to be located within the end cap 320 prior to use, and can be located elsewhere. Fig. 10A and 10B As shown, the tether 330 that secures the end cap 320 to the blood treatment device connector 310 may include a cup 332 into which the outlet portion 242 of the cannula 240 may be inserted prior to use. In such an embodiment, the outlet portion 242 of the cannula 240 may remain covered even after the user has disconnected the end cap 320 and connected the blood treatment device connector 310 to the blood treatment 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 treatment device.

[0073] Also like Fig. 10A and 10B As shown, the cannula 240 can also include a gripping element 246 (e.g., a fin or similar structure) extending from the body 244 of the cannula 240. In such an embodiment, the gripping element can be used to grasp and manipulate the cannula 240 during removal of the cannula 240 from the end cap 320 or cup 332 within the tether and during connection of the cannula 240 to the plasma container 100. The gripping element 246 can be sized to allow a user to grasp the cannula 240 (e.g., using their thumb and index finger).

[0074] Although the above-described embodiment uses the hydrophobic membrane 230 as the exhaust filter, other embodiments may utilize different exhaust filters. Figures 11A to 11C As shown, some embodiments may utilize a plug-type filter 410. In such embodiments, the top cover 120 may have an exhaust skirt 420 extending from (e.g., extending downwardly from) the underside 124 of the top cover 120, and the plug-type filter 410 is located in the exhaust skirt 420. The plug-type filter 410 may be secured within the exhaust skirt 420 in any manner, including but not limited to press fitting or swaging.

[0075] It should be noted that the plug filter 410 can be any number of filter types that allow air to escape through the vent 160 and provide a sterile barrier. In some embodiments, the plug filter 410 can be a hydrophobic filter (such as the membrane 230 discussed above) and / or the plug filter 410 can be a Porex TM Additionally or alternatively, in other embodiments, the plug filter 410 may be a self-sealing filter (also manufactured by Porex TM 160 ), which expands upon contact with liquid to seal the vent 160 and prevent the liquid within the plasma container 100 from leaking out of the vent 160. For example, once the plasma collection process is complete and the user inverts the container 100 to collect the sample (as described above), the plasma will contact the plug filter 410, thereby causing it to self-seal and prevent the plasma from leaking out of the vent 160.

[0076] In some embodiments, particularly those using a self-sealing plug filter, it is beneficial to minimize the risk of fluid (e.g., plasma) contacting the vent filter (e.g., plug filter 410) during filling of the plasma container 100. To this end, the cap 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, Figures 11A-11C As best shown, a splash guard 430 may extend downwardly from the bottom of the exhaust skirt 420. One or more splash guards (e.g., a wall of 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 Figures 11A-11C Two splash guards 430 are shown, but other embodiments may have only a single splash guard 430 or more than two splash guards 430 .

[0077] like Fig.11A and 11BAs best shown, the underside 124 of the top cover 120 can have a number of features that help stiffen the top cover 120. For example, the top cover 120 can include reinforcing ribs 440 on the underside 124 of the top cover 120. The ribs 440 can be asymmetrical and irregular to help prevent resonance-induced nodal vibrations in the top cover 120 during the ultrasonic welding process (e.g., securing the top cover 120 to the plasma container 100).

[0078] FIG. 12A to FIG. 12E The top cover 120 of the plasma storage container 100 with an alternative valve mechanism (e.g., a needleless valve) is shown. In such an embodiment, in addition to the skirt 190 extending from the underside 124 of the top cover 120, the top cover 120 can include a valve housing 510 extending upward from the top surface 122 of the top cover 120. The valve housing 510 can form an interior 512 in which the valve mechanism can be located, and can have an inlet portion 514 whose internal geometry conforms to a standard Luer taper (e.g., the inner diameter of the inlet portion 514 can taper to conform to the Luer standard). The inlet 170 can be located at the proximal end of the inlet portion 514 so that when the cannula 240 is connected, a portion of the cannula 240 will enter the inlet portion 514 of the valve housing 510.

[0079] The valve housing 510 is located below the inlet portion 514 and may include a second / distal portion 516 having an inner diameter that is larger than the inner diameter of the inlet portion 514. It is important to note that the larger inner diameter may be like Figures 12A to 12E The diameter of the second / distal portion 516 may not gradually expand as shown, or the increase in diameter may occur in one 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 more detail below, the increased diameter portion 516 helps the orifice 210 in the valve mechanism open during operation.

[0080] The valve member can be an elastomeric element 520 that includes a proximal portion 522 (e.g., a diaphragm) 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 is preferably open (e.g., to allow fluid to flow through 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 can include a flange 527 that extends radially outward from the distal portion 521 of the valve member 520 and contacts the shelf portion 192 of the skirt 190. Similar to the above-described embodiments, the valve member / elastic element 520 can be secured within the cap 120 by a swaged connector (or similar connector). To further support the valve member / elastic member 520 within the inlet housing 510 and help position the proximal portion 522 at the inlet 170, the valve member / elastic member 520 has a shoulder 523 that contacts the inner surface of the inlet housing 510 (e.g., angled / gradually enlarging the diameter of the second / distal portion 516) when the valve mechanism is in a closed mode (e.g., when the cannula 240 is not connected).

[0081] During operation (e.g., during connection of the cannula 240), the user can insert the cannula 240, which can also have a Luer taper on the outlet portion 242, into the inlet 170. When 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 orifice 210 will open (e.g., when the proximal portion 522 enters the larger inner diameter portion of the inlet housing 510) to form fluid communication between the cannula 240 and the valve interior 526 (and the 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 resting position with the inlet portion 514. This in turn causes the orifice 210 to close.

[0082] It should be noted that in some embodiments, the cannula 240 (eg, the outlet portion 242 of the cannula 240) does not enter (or only partially enters) the orifice 210. Fig.12E As shown, the outlet portion 242 of the cannula 240 can be sized so that it is relatively large compared to the size of the orifice 210. In such an embodiment, the outlet portion 242 of the cannula 240 will only contact the top surface of the proximal portion 522 of the valve member and will not enter the orifice 210.

[0083] As described above, some embodiments may have a retainer / clamp 180 that secures the cannula 240 to the plasma container 100 during use and prevents the cannula 240 from accidentally disconnecting from the inlet 170. Additionally or alternatively, as Fig. 12A As shown in FIG. 5-E, the outer surface of the inlet housing 510 may also have an inlet thread 515 (e.g., a Luer lock thread) for connecting the cannula 240 and locking the cannula 240 in place. To this end, the cannula 240 may include a skirt 241 having an internal thread 243 (e.g., on the inner surface of the skirt 241) that engages with the thread 515 on the inlet housing 510 ( Fig.12E The inlet threads 510 and the threads 243 in the cannula skirt 241 may conform to ANSI / ISO standards (eg, they may be capable of accommodating / connecting to medical devices that conform to ANSI / ISO standards).

[0084] It is important to note that although Luer lock threads are discussed above, other embodiments may use other connectors, such as BNC connectors. For example, some embodiments may utilize connectors that only partially lock along a bend. Such connectors may include radial protrusions (on the inlet housing 510 or cannula 240) that mate with an inclined surface (e.g., on the inlet housing 510 or cannula).

[0085] FIG. 13A to FIG. 13C A cap is shown having a plasma storage container with a different mechanism for connecting the cannula 240 to the inlet 170 of the cap 120. Similar to the above and Figure 4 and 5 The top cover 120 shown, Figures 13A-13C The illustrated cap may include a septum 200 (e.g., a valve mechanism) located and secured within a skirt 190 extending from the underside of the cap 120. The septum 200 may be swaged within the skirt 190 and may have an orifice 210 (e.g., a normally closed orifice) extending therethrough to allow the cannula 240 to enter the interior of the container 100 when connected. As described above, the orifice 210 may be one or more slits extending through the septum 200, or may be a slit 210 extending through the septum 200, as described above. Fig.14 As shown, it may be a pre-punctured hole that opens under elastic deformation when the cannula 240 is connected.

[0086] To assist in the connection and disconnection of the cannula 240, the top cap 120 may have a cannula support structure 710 extending from the top surface 122 of the top cap 120 around the inlet 170. The cannula support structure 710 may be cup-shaped / U-shaped such that the walls 712 of the structure 710 slope downward to form a channel 714 within the support structure 710. As discussed in more detail below, after being connected to the inlet 170, the cannula 240 may reside within the channel 714, and the cannula support structure 710 (e.g., the top surface 716 of the structure) may act as a cam surface to assist the user in disconnecting the cannula 240 from the top cap 120.

[0087] In the interior of the inlet 170, the top cover 120 may have an inwardly protruding protrusion 720 (eg, an inlet protrusion) extending from the inner surface of the inlet 170 ( Fig.15 During connection of cannula 240, protrusion 720 may interact with protrusion 810 on cannula 240 ( Fig.16 ) to secure the cannula 240 in place. For example, when 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. When the user applies additional pressure, the cannula protrusion 810 will snap onto the inlet protrusion 720 so that the inlet protrusion 720 resides in the recess 820 on the cannula 240 ( Fig.17A / 17B). At this point, the cannula 240 is Fig.18 200 is shown fully connected, and the orifice 210 in the septum 200 is open to allow fluid (e.g., plasma) to be collected in the container 100. In addition, due to the interaction between the cannula protrusion 810 and the inlet protrusion 720, the cannula 240 may not be inadvertently disconnected from the container 100 (e.g., due to accidental collision, etc.).

[0088] although Fig.15 and Fig.17A 170, but in other embodiments, the protrusion 720 may only extend around a portion of the inlet 170. Additionally or alternatively, some embodiments may include more than one inlet protrusion 720 (e.g., two or more) spaced apart around the diameter of the inlet 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 multiple protrusions 810 and recesses 820 spaced apart around the circumference of the cannula 240.

[0089] 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 onto 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 pass over each other more easily.

[0090] As described above, the top surface 716 of the cannula support structure 710 can serve as a cam surface that facilitates disconnection of the cannula 240 after fluid collection is complete. To this end, once fluid collection is complete and the user wishes to disconnect the cannula 240, the user can grasp the cannula 240 (e.g., via the body 240 and / or the gripping element 246) and rotate the cannula 240 (e.g., clockwise or counterclockwise) ( Fig.19 ). When the user rotates the cannula 240, the cannula 240 will begin to slide upward along the top surface 716 of the support structure 710, thereby causing the inlet protrusion 720 to snap onto the cannula protrusion 810 to disconnect the cannula 240 from the inlet 170.

[0091] During processing, the user / technician may need to plug various tubing / tubes within the collection system (e.g., tubes within tubing kit 300 or other tubing used during collection). To this end, some embodiments may incorporate additional clamps within the kit. For example, Fig.16 , 18 As shown in FIG. 19 , the gripping element 246 may be formed with a tube clamp 248. In use, if a technician wishes to block a portion of a test tube, the technician may slide the test tube into the tube clamp 248, which in turn deforms the test tube and closes to prevent fluid from flowing through the test tube.

[0092] 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 this end, some embodiments may include a sterile barrier that may be placed over the inlet 170. For example, Fig. 20 As shown, the top cover 120 can include a sterile barrier 610 (e.g., a removable label) that can be secured to the top surface 122. The sterile barrier 610 can be secured to the top cover in a variety of ways, including, but not limited to, adhesives, welding, and bonding. To assist in removing the sterile barrier 610, the sterile barrier 610 can include a pull tab 612 that a user can grasp and pull to peel the barrier 610 away from the inlet 170. In embodiments that include a valve housing 510, the top cover 120 can alternatively include a removable end cap / cover 620 (e.g., on the inlet portion 514) located on the valve housing 510. Fig.21). Like the skirt 241 of the cannula 240 , the interior of the end cap / cover 620 may include threads (not shown) that screw onto threads on the inlet portion 514 .

[0093] For similar FIG. 13A to FIG. 13C In the illustrated embodiment, the end cap 900 may have a lower portion 910 that, when connected to the plasma container 100, extends into the inlet 170 to close the inlet and maintain sterility (see Figure 22 to Figure 24 ). The lower portion 910 extending into the inlet 170 can have a protrusion that interacts with the inlet protrusion 720 in a manner similar to the cannula protrusion, and / or the lower portion 910 can be sized so that it is press-fit into the inlet 170. On either side of the end cap 900 (or both sides of the end cap 900), the end cap 900 can include a mating portion 930 that rests within / mates with the channel 714 within the support structure 710. To remove the end cap 900 in a manner similar to the cannula 240, a user can grasp and rotate the end cap 900 to slide the mating portion 930 upward along the top surface 716 (e.g., a cam surface) of the support structure 710, disconnecting the end cap 900 from the inlet 170. Alternatively, the user can simply grasp the end cap 900 and pull the end cap 900 out of the inlet 170. To make it easier for a user to grasp the end cap 900 during removal, the top of the end cap 900 may have a flange 920 extending from the end cap 900 .

[0094] Although the above-described embodiments eliminate both the port for introducing plasma into the prior art container and the port for venting the prior art container (e.g., the port extending from the plasma container and the tubing segment connected to the port, as described above), some embodiments may eliminate only a single port (e.g., the container may retain the port). For example, some embodiments may utilize the inlet port 170 and the valve member / diaphragm 200, but retain the vent port (e.g., the vent port extending from the plasma container and having the tubing segment connected thereto). Alternatively, some embodiments may utilize the vent port 160 and the hydrophobic membrane 230 (or the plug filter 410), but retain the port for introducing plasma into the bottle (e.g., the inlet opening extending from the plasma container and having the tubing segment extending therefrom).

[0095] 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 described above, some embodiments of the present invention can reduce and / or eliminate the risk of breaking and including product sterility. In addition, various embodiments of the present invention can eliminate the need for thermal / RF sealing equipment and processes for sealing tubing prior to shipping and storage. In addition, because embodiments of the present invention allow sample collection directly through the septum 200 (e.g., as opposed to first drawing plasma into a portion of the tubing in many prior art systems), the present invention can collect a highly representative plasma sample with little / no loss.

[0096] The embodiments of the present invention described above are exemplary only; the present invention is not limited to the disclosed embodiments. Many variations and modifications will be apparent to those skilled in the art. All such variations and modifications are intended to fall within the scope of the present invention as defined by any of the appended claims.

Claims

1. A top cover for a plasma storage container, comprising: a cap body defining a structure of the cap and configured to seal an opening of the plasma storage container; an inlet opening extending through the top cover body; a valve mechanism at least partially disposed within the inlet opening, the valve mechanism including an aperture therethrough, the aperture configured to open upon connection of the cannula to the plasma storage container, thereby providing access to the interior of the plasma storage container; a cannula support structure extending from a top surface of the top cover, the cannula support structure defining a channel configured to support the cannula when connected to a plasma storage container; a locking mechanism configured to lock the cannula to the top cover; an exhaust port extending through the top cover body; and An exhaust filter is configured to allow air to escape through the exhaust port during filling of the plasma storage container.

2. The cap for a plasma storage container of claim 1, wherein the valve mechanism comprises a diaphragm.

3. The top cover for a plasma storage container according to claim 2, further comprising: A skirt extends from the underside of the top cover body around the first opening, and the diaphragm is positioned and fixed in the skirt.

4. The cap for a plasma storage container according to claim 3, wherein the diaphragm is secured within the skirt by a swaged connection.

5. The cap for a plasma storage container according to claim 4, wherein the skirt and / or the swaged connector exerts a radially inward force on the diaphragm, the radially inward force holding the diaphragm fixed within the skirt.

6. The cap for a plasma storage container according to claim 1, wherein the orifice is closed when the cannula is not connected.

7. The cap for a plasma storage container of claim 1, wherein the aperture is configured to allow the cannula to at least partially enter the aperture after the cannula is connected to the plasma storage container.

8. The cover for a plasma storage container of claim 1, wherein the locking mechanism comprises a locking protrusion extending from the cover body into the inlet opening, the locking protrusion being configured to snap into a recess within the cannula during connection of the cannula.

9. The cap for a plasma storage container according to claim 8, wherein the cannula includes a cannula protrusion extending from a surface of the cannula, and the locking protrusion is configured to snap onto the cannula protrusion and enter into the recess during connection of the cannula.

10. The cap for a plasma storage container according to claim 9, wherein at least one surface of the locking protrusion is angled to allow the locking protrusion to snap onto the cannula protrusion.

11. The cover for a plasma storage container according to claim 8, wherein the cannula support structure includes a cam surface, and rotation of the cannula causes the cannula to slide upward along the cam surface, thereby disengaging the locking protrusion from the recess and disconnecting the cannula from the plasma storage container.

12. The cap for a plasma storage container of claim 1, further comprising an end cap configured to be connected to the inlet opening, the end cap providing a sterile barrier for the inlet opening prior to connecting the cannula.

13. The cap for a plasma storage container of claim 12, wherein the end cap includes a lower portion that extends into the inlet opening when connected to the plasma storage container.

14. The cap for a plasma storage container of claim 12, wherein the end cap includes a mating portion configured to mate with at least a portion of the channel of the cannula support structure.

15. The cap for a plasma storage container of claim 1, wherein the cannula includes a gripping element configured to allow a user to grip the cannula during use.

16. The cover for a plasma storage container of claim 15, wherein the gripping element comprises a clamp.

17. The cap for a plasma storage container of claim 1, wherein the cannula is part of a tubing set connected to a blood processing device.

18. The cap for a plasma storage container according to claim 17, wherein the tubing kit comprises: a connector configured to connect to a blood component separation device; and an end cap secured to the connector via a tether.

19. The cap for a plasma storage container of claim 18, wherein prior to use, the cannula is secured to the tether.

20. The cover for a plasma storage container of claim 1, wherein the inlet opening is larger than the exhaust port.

21. The cap for a plasma storage container according to claim 1, wherein the vent filter comprises a hydrophobic membrane located on a lower side of the cap body and covering the vent port.

22. The cover for a plasma storage container according to claim 21, wherein the cover body includes at least one flow channel on an underside of the cover body, the at least one flow channel being in fluid communication with the vent to allow air to flow into and out of the plasma storage container through the vent.

23. The cap for a plasma storage container according to claim 21, wherein a surface area of ​​the hydrophobic membrane is larger than a cross-sectional area of ​​the vent.

24. The cover for a plasma storage container of claim 21, wherein the hydrophobic membrane is sealed to an underside of the cover body.

25. The cap for a plasma storage container of claim 1, wherein the vent filter comprises a plug filter.

26. The cap for a plasma storage container according to claim 25, wherein the plug filter is a self-sealing filter configured to seal the vent when the plug filter is exposed to a liquid.

27. The cover for a plasma storage container according to claim 25, further comprising an exhaust skirt extending from the cover body around the exhaust port, wherein the plug filter is located and fixed in the exhaust skirt.

28. The cover for a plasma storage container of claim 27, wherein the vent skirt extends from an underside of the cover body.

29. The cap for a plasma storage container of claim 28, further comprising at least one splash guard extending from the vent skirt, the splash guard being configured to prevent liquid from contacting the plug filter during filling of the plasma storage container.

30. The cap for a plasma storage container of claim 1, wherein the valve mechanism is further configured to allow a sample collection container holder to pass through the aperture to gain access to the interior of the plasma storage container.

31. The cover for a plasma storage container of claim 30, wherein the sample collection container holder is a vacuum container holder.

32. The cover for a plasma storage container of claim 1, further comprising at least one reinforcing rib on an underside of the cover.

33. A top cover for a plasma storage container, comprising: a cap body defining a structure of the cap and configured to seal an opening of the plasma storage container; an inlet opening extending through the top cover body; a valve mechanism at least partially positioned within the inlet opening, the valve mechanism including an orifice therethrough, the orifice configured to open upon connection of the cannula to the plasma storage container to provide access to the interior of the plasma storage container; a locking mechanism configured to lock the cannula to the cap, the locking mechanism having a locking protrusion extending from the cap body into the inlet opening, the locking protrusion being configured to snap into a recess within the cannula during connection of the cannula; an exhaust port extending through the top cover body; and An exhaust filter is configured to allow air to escape through the exhaust port during filling of the plasma storage container.

34. The cover for a plasma storage container of claim 33, wherein the valve mechanism comprises a diaphragm.

35. The cap for a plasma storage container according to claim 34, further comprising a skirt extending from an underside of the cap body around the first opening, the diaphragm being positioned and fixed within the skirt.

36. The cap for a plasma storage container of claim 35, wherein the diaphragm is secured within the skirt by a swaged connection.

37. The cap for a plasma storage container of claim 36, wherein the skirt and / or the swaged connector exerts a radially inward force on the diaphragm, the radially inward force holding the diaphragm fixed within the skirt.

38. The cap for a plasma storage container of claim 33, wherein the orifice is closed when the cannula is not connected.

39. The cap for a plasma storage container of claim 33, wherein the aperture is configured to allow the cannula to at least partially enter the aperture after the cannula is connected to the plasma storage container.

40. The cap for a plasma storage container according to claim 33, wherein the cannula includes a cannula protrusion extending from a surface of the cannula, and the locking protrusion is configured to snap onto the cannula protrusion and enter into the recess during connection of the cannula.

41. The cap for a plasma storage container according to claim 40, wherein at least one surface of the locking protrusion is angled to allow the locking protrusion to snap onto the cannula protrusion.

42. The cover for a plasma storage container of claim 33, further comprising a cannula support structure extending from a top surface of the cover, the cannula support structure defining a channel configured to support a cannula when connected to the plasma storage container.

43. The cover for a plasma storage container according to claim 42, wherein the cannula support structure includes a cam surface, and rotation of the cannula causes the cannula to slide upward along the cam surface, thereby disengaging the locking protrusion from the recess and disconnecting the cannula from the plasma storage container.

44. The cap for a plasma storage container of claim 33, further comprising an end cap configured to be connected to the inlet opening, the end cap providing a sterile barrier for the inlet opening prior to connection of the cannula.

45. The overcap for a plasma storage container of claim 44, wherein the end cap includes a lower portion that extends into the inlet opening when connected to the plasma storage container.

46. ​​The cap for a plasma storage container of claim 44, wherein the end cap includes a mating portion configured to mate with at least a portion of a channel of a cannula support structure.

47. The cap for a plasma storage container of claim 33, wherein the cannula includes a gripping element configured to allow a user to grip the cannula during use.

48. The cover for a plasma storage container of claim 47, wherein the gripping element comprises a clamp.

49. The cap for a plasma storage container of claim 33, wherein the cannula is part of a tubing set connected to a blood processing device.

50. The cap for a plasma storage container of claim 49, wherein the tubing kit comprises: a connector configured to be connected to a blood component separation device; and an end cap secured to the connector via a tether.

51. The cap for a plasma storage container of claim 50, wherein the cannula is secured to the tether prior to use.

52. The cover for a plasma storage container of claim 33, wherein the inlet opening is larger than the exhaust port.

53. The cap for a plasma storage container according to claim 33, wherein the vent filter comprises a hydrophobic membrane located on the underside of the cap body and covering the vent port.

54. A cover for a plasma storage container according to claim 53, wherein the cover body includes at least one flow channel on the underside of the cover body, and the at least one flow channel is fluidly connected to the exhaust port to allow air to flow into and out of the plasma storage container through the exhaust port.

55. The cover for a plasma storage container according to claim 53, wherein the surface area of ​​the hydrophobic membrane is larger than the cross-sectional area of ​​the vent.

56. The cover for a plasma storage container of claim 53, wherein the hydrophobic membrane is sealed to the underside of the cover body.

57. The cover for a plasma storage container of claim 33, wherein the vent filter comprises a plug filter.

58. The cap for a plasma storage container according to claim 57, wherein the plug filter is a self-sealing filter configured to seal the vent when the plug filter is exposed to liquid.

59. The cover for a plasma storage container according to claim 57, further comprising an exhaust skirt, the exhaust skirt extending from the cover body around the exhaust port, the plug filter being located and fixed in the exhaust skirt.

60. The cover for a plasma storage container of claim 59, wherein the vent skirt extends from an underside of the cover body.

61. The cap for a plasma storage container of claim 60, further comprising at least one splash guard extending from the vent skirt, the splash guard configured to prevent liquid from contacting the plug filter during filling of the plasma storage container.

62. The cover for a plasma storage container of claim 33, wherein the valve mechanism is further configured to allow a sample collection container holder to pass through the aperture to gain access to the interior of the plasma storage container.

63. The cover for a plasma storage container of claim 62, wherein the sample collection container holder is a vacuum container holder.

64. The cover for a plasma storage container of claim 33, further comprising at least one reinforcing rib located on an underside of the cover.

65. A top cover for a plasma storage container, comprising: a cap body defining a structure of the cap and configured to seal an opening of the plasma storage container; an inlet opening extending through the top cover body; a valve mechanism at least partially located within the inlet opening, the valve mechanism comprising a resilient member having a diaphragm proximate a top of the resilient member, a valve wall extending downwardly from the diaphragm and defining an open valve interior, and an open distal end, the valve mechanism also having an orifice through at least a portion of the resilient member, the orifice configured to open when the cannula is connected to the plasma storage container, thereby providing access to the interior of the plasma storage container; a locking mechanism configured to lock the cannula to the top cover; an exhaust port extending through the top cover body; as well as An exhaust filter is configured to allow air to escape through the exhaust port during filling of the plasma storage container.

66. The cap for a plasma storage container of claim 65, wherein the aperture extends through the septum.

67. The cover for a plasma storage container of claim 65, further comprising a valve housing extending from a top surface of the cover, the valve mechanism being at least partially located within the valve housing.

68. The cover for a plasma storage container of claim 67, wherein the valve housing includes an inlet portion, the diaphragm being at least partially located within the inlet portion.

69. The cap for a plasma storage container of claim 68, wherein an inner surface of the inlet portion comprises a Luer taper.

70. The cover for a plasma storage container according to claim 68, wherein the valve housing further comprises a second portion located below the inlet portion, the inner diameter of the second portion being larger than the inner diameter of the inlet portion.

71. The cover for a plasma storage container according to claim 68, wherein the valve housing further comprises a second portion located below the inlet portion, the inner diameter of the second portion expanding along the length of the second portion.

72. The cap for a plasma storage container of claim 71, wherein connection of said cannula to said plasma storage container causes said diaphragm to move from said inlet portion to said second portion of said valve housing, thereby allowing said orifice to open.

73. The cover for a plasma storage container of claim 67, wherein said valve housing comprises said locking mechanism.

74. The cap for a plasma storage container of claim 73, wherein the locking mechanism comprises Luer threads, the cannula having a skirt and threads within the skirt, the threads being configured to engage with Luer threads on the valve housing.

75. The cover for a plasma storage container according to claim 65, further comprising a skirt extending from an underside of the cover body around the first opening, at least a portion of the valve mechanism being located and fixed within the skirt.

76. The cover for a plasma storage container of claim 75, wherein at least a portion of the valve mechanism is secured within the skirt by a swaged connection.

77. The cap for a plasma storage container of claim 65, wherein the orifice is closed when the cannula is not connected.

78. The cap for a plasma storage container of claim 65, wherein the aperture is configured to allow the cannula to at least partially enter the aperture after the cannula is connected to the plasma storage container.

79. The cap for a plasma storage container of claim 65, wherein the cannula includes a gripping element configured to allow a user to grip the cannula during use.

80. The cover for a plasma storage container of claim 79, wherein the gripping element comprises a clamp.

81. The cap for a plasma storage container of claim 65, wherein the cannula is part of a tubing set connected to a blood processing device.

82. The cap for a plasma storage container of claim 81, wherein the tubing kit comprises: a connector configured to be connected to a blood component separation device; and an end cap secured to the connector via a tether.

83. The cover for a plasma storage container of claim 65, wherein the inlet opening is larger than the exhaust port.

84. The cap for a plasma storage container of claim 65, wherein the vent filter comprises a hydrophobic membrane located on an underside of the cap body and covering the vent port.

85. A cover for a plasma storage container according to claim 84, wherein the cover body includes at least one flow channel on the underside of the cover body, and the at least one flow channel is connected to the exhaust port fluid to allow air to flow into and out of the plasma storage container through the exhaust port.

86. The cover for a plasma storage container according to claim 84, wherein the surface area of ​​the hydrophobic membrane is larger than the cross-sectional area of ​​the vent.

87. The cover for a plasma storage container of claim 84, wherein the hydrophobic membrane is sealed to the underside of the cover body.

88. The cover for a plasma storage container of claim 65, wherein the vent filter comprises a plug filter.

89. The cap for a plasma storage container of claim 88, wherein the plug filter is a self-sealing filter configured to seal the vent when the plug filter is exposed to a liquid.

90. The cover for a plasma storage container according to claim 88, further comprising an exhaust skirt, wherein the exhaust skirt extends from the cover body around the exhaust port, and the plug filter is located and fixed in the exhaust skirt.

91. The cover for a plasma storage container of claim 90, wherein the vent skirt extends from an underside of the cover body.

92. The cover for a plasma storage container of claim 91, further comprising at least one splash guard extending from said vent skirt, said splash guard being configured to prevent liquid from contacting said plug filter during filling of said plasma storage container.

93. The cover for a plasma storage container of claim 65, wherein the valve mechanism is further configured to allow a sample collection container holder to pass through the aperture to gain access to the interior of the plasma storage container.

94. A cover for a plasma storage container according to claim 93, wherein the sample collection container holder is a vacuum container holder.

95. The cover for a plasma storage container of claim 65, further comprising at least one reinforcing rib located on an underside of the cover.

96. A plasma storage container, comprising: a container body defining the structure of the plasma storage container and defining an interior; A cap as claimed in any one of claims 1 to 95.

Images