CN112312876B - Plasma bottles without seals and their caps - Google Patents
Plasma bottles without seals and their caps Download PDFInfo
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- CN112312876B CN112312876B CN201980041297.7A CN201980041297A CN112312876B CN 112312876 B CN112312876 B CN 112312876B CN 201980041297 A CN201980041297 A CN 201980041297A CN 112312876 B CN112312876 B CN 112312876B
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- storage container
- plasma storage
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1412—Containers with closing means, e.g. caps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1475—Inlet or outlet ports
- A61J1/1481—Inlet or outlet ports with connection retaining means, e.g. thread or snap-fit
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1406—Septums, pierceable membranes
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- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Hematology (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- External Artificial Organs (AREA)
- Closures For Containers (AREA)
Abstract
用于血浆存储容器的顶盖包括顶盖主体，该顶盖主体限定顶盖的结构并密封血浆存储容器的开口。该顶盖还包括第一开口和延伸穿过顶盖主体的排气口。阀机构至少部分地位于顶盖主体内，并且包括穿过其中的孔口。该孔口在连接钝插管时打开，以提供通往血浆存储容器内部的途径。顶盖还包括排气过滤器。该排气过滤器允许空气在血浆收集过程中通过排气口排出。
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
RELATED APPLICATIONS
This PCT patent application claims priority from U.S. application No.16/161,482 entitled "Sealer-LESS PLASMA Bottle and Top for Same" filed on 10/16/2018 (attorney docket No. 130670-08102, assigned to Christopher s. McDowell and Matthew j. Murphy, the disclosures of which are incorporated herein by reference in their entirety).
U.S. provisional patent application No. 62/674,913 (attorney docket No. 1611/C89, assigned to Christopher s.mcdowell and Matthew j.murphy, the disclosures of which are incorporated herein by reference in their entireties) entitled "Sealer-LESS PLASMA Bottle and Top for Same" filed on date 22 in 2018 in this PCT patent application and U.S. patent application No. 16/161,482.
U.S. patent application Ser. No. 16/161,482 is also part of PCT application Ser. No. PCT/US2017/032824 (attorney docket No. 1611/C81WO, assigned to Christopher S.McDowell, the entire contents of which are incorporated herein by reference) entitled "Sealer-LESS PLASMA Bottle and Top for Same" filed on month 5, 16, and claims priority from all priority dates of PCT application Ser. No. PCT/US2017/032824, entitled "Sealer-LESS PLASMA Bottle and Top for Same", filed on month 5, 16, 2017.
PCT application No. PCT/US2017/032824 claims priority from U.S. provisional application No.62/337,031 entitled "Sealer-LESS PLASMA Bottle and Top for Same," filed 5/16 a 2016 (attorney docket No. 1611/C68, assigned inventor Christopher s.mcdowell, the entire contents of which are incorporated herein by reference).
Technical Field
The present invention relates to blood component storage containers, and more particularly to plasma storage containers.
Background
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 whole blood components are typically suspended. Whole blood represents about 55% by volume of plasma. Plasma plays an important role in the human circulatory system, including transporting blood cells, conducting heat and transporting waste. Pure plasma contains clotting factors that increase the rate of blood clotting, making it useful in surgery and hemophilia treatment. Stock whole blood is sometimes used to replace blood lost by a patient during surgery or due to trauma. However, if there is no whole blood inventory that is compatible with the patient's blood type, plasma may sometimes be used to replace some of the lost blood. Plasma also contains proteins, which can be used in the manufacture of medicaments for immunodeficiency and other proteinaceous diseases. In addition, the plasma may be frozen and stored for a relatively long period of time before it is needed.
To collect plasma, whole blood may be collected from the donor and the plasma may be later separated from other components of the donated whole blood, for example in a laboratory. However, in other cases, the plasma is separated from other components of the 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 blood from a donor or patient flows through a device, such as a centrifuge, that separates out a particular component and returns the remaining blood to the donor or patient. Plasmapheresis is a medical procedure involving the separation of plasma from whole blood.
Collected plasma for pharmaceutical use is typically stored in plastic bottles. A typical plasma bottle includes two ports, one for introducing plasma into the bottle and the other for expelling air out of the bottle. Each port typically protrudes from a surface of the plasma bottle (e.g., a top cap of the plasma bottle) and may have a conduit connected thereto. After the plasma is collected in the bottle, the tubing is severed using a radio frequency sealing clamp and a short (typically about 1-1/2 inch long) sealing tubing nipple is attached to the port extending from the plasma bottle. These short tubes often protrude from the bottleneck and can cause problems during transportation and storage. For example, when plasma is frozen, the plastic of the nipple and/or port becomes brittle and may fracture, thereby violating the requirement to keep the plasma in a sealed container.
Disclosure of Invention
In a first embodiment of the present invention, a top cover for a plasma storage container is provided. The cap includes a cap body defining a structure of the cap and sealing an opening of the plasma storage container. The cap may further include a first opening and a vent extending through the cap body. The septum may be at least partially within the first opening and may include an aperture therethrough. The septum may allow the blunt cannula to pass through the aperture to gain access to the interior of the plasma storage container. The cap may further include a hydrophobic membrane located at the underside of the cap body. The membrane covers the vent and may allow air to move through the vent during filling of the plasma storage container while preventing ingress of harmful microorganisms.
In some embodiments, the cap may further comprise a skirt extending downwardly from the underside of the cap body around the first opening. The diaphragm may be located and secured within the skirt (e.g., by swaging the connection). Alternatively, the diaphragm may be overmolded with the skirt. The skirt and/or swage connection may exert a compressive retention force on the aperture. When the blunt cannula is not connected, the orifice may be closed and the first opening may be larger than the vent. Additionally or alternatively, the septum may allow the sample collection container holder to pass through the aperture to gain 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 set that is connected to a blood processing set.
The cap body may further include at least one flow channel on an underside of the cap body. 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 hydrophobic membrane may have a surface area greater than a cross-sectional area of the vent, and/or the hydrophobic membrane may be sealed and/or ultrasonically welded to an energy director on the underside of the cap body. The cap may include a retaining element (e.g., a clip) located on the top surface of the cap body. The holder may hold the blunt cannula in place during filling of the plasma storage container.
According to additional embodiments, a plasma storage container includes a container body defining a structure of the plasma storage container and defining an interior. The container includes a top cap configured to seal an opening of the plasma storage container. The top cover may include a first opening and a vent extending through the top cover of the container. The septum may be at least partially within the first opening and may include a pre-pierced aperture therethrough. The septum/orifice allows the blunt cannula to pass through the orifice to gain access to the interior of the plasma storage container. The container also includes a hydrophobic membrane positioned on the underside of the container top cover. The membrane covers the vent and allows air to pass through the vent during plasma collection. The first opening may be larger than the exhaust port.
In some embodiments, the plasma storage container may include a skirt extending from a lower side of the container top cover around the first opening. The diaphragm may be positioned and secured within the skirt, for example, by swaging the connection. Additionally or alternatively, the septum may be overmolded within the skirt. The skirt and/or swage connection may exert a radially inward force on the orifice that is biased inward to close the orifice. When the blunt cannula is not attached, the orifice may be closed.
The container top may include at least one flow channel on an underside of the container top. 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 hydrophobic membrane may have a surface area greater than the cross-sectional area of the exhaust port. Additionally or alternatively, the hydrophobic membrane may be ultrasonically welded to the underside of the container top lid and/or may be sealed to the underside of the container top lid.
In additional embodiments, the plasma storage container may include a retainer located on a top surface of the container top cover. The holder 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 set that is connected to a blood processing set.
According to additional embodiments, a cap for a plasma storage container may include a cap body defining a structure of the cap and sealing an opening of the plasma storage container. The cap may further include a first opening and an exhaust port extending through the cap body. The valve mechanism may be at least partially located within the cap body. The valve mechanism may have an aperture 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 a vent filter that allows air to vent through the vent during filling of the plasma storage container.
The valve mechanism may include a diaphragm, and the aperture may extend through the diaphragm. The aperture may allow the blunt cannula to at least partially enter the aperture after the blunt cannula is connected to the plasma storage container. In some embodiments, the cap may include a skirt extending from the underside of the cap body around the first opening. The diaphragm may be located and secured within the skirt (e.g., by swaging the connection). The skirt and/or swage connection may exert a radially inward force on the diaphragm to retain the diaphragm within the skirt.
In additional embodiments, the valve mechanism may include a resilient member having (1) a diaphragm located near a 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 located at least partially within the valve housing. The valve housing may include an inlet portion. The septum 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 may provide a sterile barrier to the first opening prior to attachment of the blunt cannula.
The valve housing may further comprise a second portion 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. The 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 orifice to open).
In additional 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 luer threads on the valve housing. The first opening may be larger than the exhaust port.
The exhaust filter may include a hydrophobic membrane located at an underside of the top cover body and covering the exhaust port. The cap body may include at least one flow channel on an underside of the cap 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 hydrophobic membrane may have a surface area greater than a cross-sectional area of the vent, and the hydrophobic membrane may be sealed to the underside of the cap body.
In other embodiments, the exhaust filter may comprise 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 cap may include a vent skirt extending from the cap body (e.g., from an underside of the cap body) and extending around the vent. The plug filter may be positioned and secured within the exhaust skirt. Moreover, the cap may include at least one splash guard extending from the exhaust skirt. The splash guard may prevent liquid from contacting the cartridge during filling of the plasma storage container.
In additional embodiments, the cap may include a removable sterile barrier seal that covers the first opening prior to connection of the blunt cannula. On the top surface, the cap 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 set that is connected to a blood processing set. The tubing set may include a connector configured to connect 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 prior to use. The cannula may include a gripping element configured to allow a user to grip the cannula during use. The top cover may further comprise at least one stiffening rib on the underside of the top cover.
According to additional embodiments, a cap for a plasma storage container includes a cap body defining a structure of the cap and sealing an opening of the plasma storage container. The cap also has an inlet opening extending through the cap body and a valve mechanism at least partially within the inlet opening. The valve mechanism has an aperture configured to open upon connection of the cannula to the plasma storage container (e.g., to provide access to the interior of the plasma storage container). The locking mechanism locks the cannula to the cap, and the cap may have a vent extending through the cap body. The vent filter allows air to vent through the vent during filling of the plasma storage container.
The valve mechanism may include and/or be a diaphragm and the cap may have a skirt extending from a lower side of the cap body around the first opening. The diaphragm may be located and secured within the skirt (e.g., by swaging the connection). The skirt and/or swage connection may exert a radially inward force on the diaphragm to retain the diaphragm 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 connecting the cannula to the plasma storage container.
The locking mechanism may comprise a locking protrusion extending from the cap body into the inlet opening. During cannula connection, the locking protrusion may snap into a recess within the cannula. The cannula may include a cannula protrusion extending from a surface of the cannula, and the locking protrusion may snap into the recess on the cannula protrusion during cannula connection. At least one surface of the locking projection may be angled to allow the locking projection to snap over the cannula projection.
In some embodiments, the cap may include a cannula support structure extending from a top surface of the cap and defining a channel configured to support a cannula when connected to the plasma storage container. The cannula support structure can include a camming surface, and rotation of the cannula can slide the cannula up the camming surface. This in turn causes the locking protrusion to disengage from the recess and disconnect the cannula from the plasma storage container.
In order to provide a sterile barrier for the inlet opening prior to connecting the cannula, the cap 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 an engagement portion that engages with at least a portion of the channel of the cannula support. The cannula may have a grip element that allows a user to grip the cannula during use and/or the grip element may comprise a clamp.
The cannula may be part of a tubing set connected to the blood processing set. For example, the tubing set may include a connector configured to connect to a blood component separation device and an end 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 and/or the vent may include a hydrophobic membrane located on the underside of the cap body and covering the vent. The cap body may have at least one flow channel on an underside of the cap 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 hydrophobic membrane may have a surface area greater than a cross-sectional area of the vent, and/or the hydrophobic membrane may be sealed to the underside of the cap body.
In other embodiments, the exhaust filter may comprise a plug filter. The plug filter may be a self-sealing filter configured to seal the vent when the plug filter is exposed to liquid. In such embodiments, the cap may include a vent skirt extending from the cap body (e.g., from the underside) around the vent. The plug filter may be positioned and secured within the exhaust skirt. The overcap may also have at least one splash guard extending from the exhaust skirt. The splash guard may prevent liquid from contacting the cartridge during filling of the plasma storage container.
On the top surface, the cap 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 stiffening rib located on the underside of the top cover.
In some embodiments, the valve mechanism may include a resilient member having (1) a diaphragm located near a 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. The top cover may have a valve housing extending from a top surface of the top cover. The valve mechanism may be located at least partially 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.
The valve housing may further comprise a second portion 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. The connection of the blunt cannula to the plasma storage container may cause the septum to move from the inlet portion to the second portion of the valve housing, 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. These threads may engage luer threads on the valve housing.
According to additional embodiments, a plasma storage container has (1) a container body defining a structure and an interior of the plasma storage container, and (2) a container top cover sealing an opening of the plasma storage container. The container may also have an inlet opening extending through the cap body and a valve mechanism at least partially within the inlet opening. The valve mechanism may have an aperture that opens when the cannula is connected to the plasma storage container (e.g., to provide access to the interior of the plasma storage container). The container/cap also has (1) a locking mechanism, (2) a vent extending through the cap body, and (3) a vent filter. The locking mechanism may lock the cannula to the top cap. The vent filter allows air to vent through the vent during filling of the plasma storage container.
Drawings
The foregoing features of the 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 according to an embodiment of the invention.
Fig. 2 schematically illustrates a top perspective view of a top cover without a membrane and a hydrophobic membrane mounted for the plasma storage container shown in fig. 1, according to an embodiment of the invention.
Fig. 3 schematically illustrates a bottom perspective view of a top cover without a membrane and a hydrophobic membrane mounted for the plasma storage container shown in fig. 1, according to an embodiment of the invention.
Fig. 4 schematically shows a top perspective view of a top cover mounted with a membrane and a hydrophobic membrane for the plasma storage container shown in fig. 1, according to an embodiment of the invention.
Fig. 5 schematically shows a bottom perspective view of a top cover mounted with a membrane and a hydrophobic membrane for the plasma storage container shown in fig. 1, according to an embodiment of the invention.
Fig. 6 schematically illustrates a top perspective view of the cap for the plasma storage container shown in fig. 1 with a blunt cannula inserted into the septum, in accordance with an embodiment of the present invention.
Fig. 7 schematically illustrates an exemplary blunt cannula for use with the plasma collection container of fig. 1, in accordance with an embodiment of the present invention.
Fig. 8 schematically illustrates an exemplary tubing set containing the blunt cannula of fig. 7, according to an embodiment of the present invention.
Fig. 9 schematically illustrates an exemplary end cap for the tubing set shown in fig. 8 with a blunt cannula inserted therein, according to an embodiment of the present invention.
Fig. 10A and 10B schematically illustrate an alternative end cap for the tubing set shown in fig. 8 according to an additional embodiment of the invention.
Fig. 11A-11C schematically illustrate an alternative top cover of a plasma storage container according to an additional embodiment of the invention.
Fig. 12A-12E schematically illustrate another alternative top cover for a plasma storage container according to an additional embodiment of the invention.
Fig. 13A-13C schematically illustrate another alternative top cover for a plasma storage container according to other embodiments of the invention.
Fig. 14 schematically illustrates the bottom of the alternative top cover shown in fig. 13A-13C according to an additional embodiment of the invention.
Fig. 15 schematically illustrates a cross-sectional view of an alternative top cover shown in fig. 13A-13C in accordance with additional embodiments of the present invention.
Figure 16 schematically illustrates a plasma container according to some examples of the invention having the top cap shown in figures 13A-C and a cannula to be inserted into the inlet opening.
Fig. 17A-17B schematically illustrate cross-sectional views of a cannula connected to the cap illustrated in fig. 13A-C, according to additional embodiments of the present invention.
Fig. 18 schematically illustrates a cannula connected to the cap shown in fig. 13A-C according to an additional embodiment of the present invention.
Fig. 19 schematically illustrates a cannula disconnected from the cap shown in fig. 13A-C according to an additional embodiment of the present invention.
Fig. 20 schematically illustrates a sterile barrier positioned on a top cover according to some embodiments of the invention.
Fig. 21 schematically illustrates an alternative sterile barrier according to an additional embodiment of the invention.
Fig. 22 to 24 schematically show a further alternative sterile barrier according to an additional embodiment of the invention.
Detailed Description
Fig. 1 is a perspective view of a plasma container 100 according to an embodiment of the invention. The plasma container 100 may have a body portion 110 and a cap 120, the cap 120 closing the 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 more detail below, plasma may be collected within the plasma container 100 and sampled through the cap 120. The body portion 110 defines an interior space 150 (e.g., interior), and the collected plasma may be stored in the interior space 150.
As shown in fig. 2 and 3, the top cover 120 includes a vent 160 through which air can pass bi-directionally during plasma collection, and an inlet 170 through which plasma can be transferred into the plasma container 100. The size of the vent 160 and inlet 170 may vary depending on the application, but in some embodiments, the inlet 170 may be substantially larger than the vent 160. In addition, the top cover 120 may include a retainer 180 extending from the top surface 122 of the top cover. As discussed in more detail below, the retainer 180 may be used to secure a blunt cannula (which is then used to transfer plasma into the container 100) to the cap 120 of the plasma container 100 when plasma is collected in the container 100. The retainer 180 may be any number of components capable of securing a blunt cannula (e.g., a standard male luer fitting). For example, the retainer 180 may be clamped with two proximally extending protrusions 182A/B that define a space 184 therebetween, and the cannula may be positioned in the space 184. In such an embodiment, the user may push the cannula into the retainer/clip 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 positioned within the space 184.
On the underside 124, the cap 120 may include a skirt 190, the skirt 190 extending distally from the cap 120 (e.g., downwardly from the cap 120) and extending around the inlet 170. To help maintain sterility of the container 100 and keep the inlet 170 closed when the container is underfilled 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 positioned and secured within the skirt 190. As best shown in fig. 4 and 5, the septum 200 may have an aperture 210 extending through the body of the septum 200. The orifice 210 may be normally closed (e.g., closed when in its natural state and not subjected to any external pressure) and/or the orifice 210 may remain closed by the radial compressive force exerted by the skirt 190 on the septum 200. For example, the diaphragm 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 holds the diaphragm 200 in the skirt 190. Additionally or alternatively, the outer diameter of the septum 200 may be greater 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 a radially inward force that will hold the orifice 210 closed.
It should be noted that although the aperture 210 is shown as a slit in fig. 4 and 5, other aperture configurations may be used. For example, the aperture 210 may include two slits formed in a cross shape. Alternatively, the aperture 210 may have more than two star-shaped or asterisk-shaped slits. It is important to note that aperture 210 (e.g., slit (s)) may be formed, for example, using conventional cutting means (e.g., razor, knife, etc.), piercing with a needle, or ultrasonic cutting methods. Additionally or alternatively, the orifice 210 may also be formed within the mold during or after the injection molding process.
To provide a sterile barrier for the vent 170, the cap may include a vent filter. For example, also on the underside 124, the top cover 120 may include a hydrophobic membrane 230 positioned below the vent 160 such that the hydrophobic membrane 230 may 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 the build up of atmospheric pressure differences in the container 100. To assist in air flow, the top cover may also include a plurality of channels 220 in the surface below the hydrophobic membrane 230. The channel 220 may extend to the edge of the vent 160 and allow air to pass through the membrane 230, for example, even if the membrane 230 is pushed against the underside 124 of the top cover 120 (e.g., during high air flow rates).
The hydrophobic membrane 230 may be ultrasonically welded to the cap 120 (or otherwise sealed to the cap 120) to prevent air leakage 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, film 230 may be secured to top cover 120 by other bonding methods including, but not limited to, adhesives, hot melt adhesives, and laser welding.
As shown in fig. 5, in order to maximize the surface area of hydrophobic membrane 230 and ensure that hydrophobic membrane 230 can handle the desired air flow into and out of container 100, hydrophobic membrane 230 may be sized so as to be substantially larger than vent/aperture 160. In addition, to further maximize the use of membrane material, the hydrophobic membrane 230 may be square.
It should be noted that the top cover 120 and the container body 110 may be formed as two separate parts and then secured together by ultrasonic welding. To help facilitate ultrasonic welding, the cap 120 may include a distally extending wall 126, which wall 126 extends over the cap of the container body 110 (e.g., over the proximal end 140 of the body 110) when the cap 120 is placed over the body 110. Additionally, on the underside 124, the cap 120 may include an energy director 128 to assist in the ultrasonic welding process (e.g., securing the cap 120 to the body 110).
During use and plasma collection, a user may connect the plasma container 100 to a blood processing device through the blunt cannula 240 (fig. 7) and the tubing set 300 (fig. 8) upon which the blunt cannula 240 may be positioned. For example, a user may connect the blood processing set connector 310 at one end of the tubing set 300 to a blood processing set (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, a 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 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 a blood processing set). 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 cap 120 (fig. 6).
When the blood processing apparatus separates 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 space 150 of the container 100 through the blunt cannula 240. As 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 build-up of pressure within the container 100. Air may also enter the container 100 through the hydrophobic/sterilizing membrane 230 and the vent/port 160, depending on the needs/requirements of the blood processing apparatus. This, in turn, will prevent a vacuum from being established within the container 100.
To help store and 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 an end cap 320, which end cap 320 may be used for both the blood processing set connector 310 and the outlet portion 242 of the cannula 240 (fig. 9). For example, end cap 320 may have an open end 322, which open end 322 may be placed over blood processing set connector 310 when not in use. Additionally, the top 324 of the end cap 320 may have an opening 326, and the outlet portion 242 of the cannula 240 may be inserted into the opening 326. In some embodiments, end cap 320 may be tethered to blood component device connector 310.
Once the plasma has been collected within 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, a user may insert a sample collection container holder (e.g., a vacuum container holder) into septum 200/aperture 210 to gain access to the plasma volume within container 100. The user may then invert the container 100 and attach the vacuum container to the holder to begin collecting plasma samples within the vacuum container. It should be noted that collecting the plasma sample in this manner may provide the most representative plasma sample in the container 100 and minimize/eliminate any loss of plasma that might otherwise be lost in a sampling device that samples through the external tubing of the cap 120.
It is important to note that the outlet portion 242 of the cannula 240 need not be located within the end cap 320 prior to use, but may be located elsewhere. For example, as shown in fig. 10A and 10B, tether 330 securing endcap 320 to blood processing set connector 310 may include cup 332 into which outlet portion 242 of 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 end cap 320 and connected the blood processing set connector 310 to the blood processing set. In addition, after use, the outlet portion 242 of the cannula 240 may be reinserted into the cup 332 even though the connector 310 is still connected to the blood processing device.
As also shown in fig. 10A and 10B, the cannula 240 may further include a gripping element 246 (e.g., fin or similar structure) extending from the body 244 of the cannula 240. In such embodiments, the gripping element may be used to grip 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 gripping element 246 may be sized to allow a user (e.g., using their thumb and index finger) to grasp the cannula 240.
Although the above embodiment uses the hydrophobic membrane 230 as an exhaust filter, other embodiments may utilize different exhaust filters. For example, as shown in fig. 11A-11C, some embodiments may utilize plug filters 410. In such embodiments, the cap 120 may have a vent skirt 420 extending from (e.g., downwardly extending from) the underside 124 of the cap 120 thereof, and the plug filter 410 is located in the vent skirt 420. Plug filter 410 may be secured within vent skirt 420 in any manner, including but not limited to press fit or swaging.
It should be noted that plug filter 410 may be any number of filter types that allow air to escape through vent 160 and provide a sterile barrier. In some embodiments, plug filter 410 may be a hydrophobic filter (e.g., membrane 230 as discussed above) and/or plug filter 410 may be a Porex TM plug filter. Additionally or alternatively, in other embodiments, the plug filter 410 may be a self-sealing filter (also sold by Porex TM) that expands upon contact with liquid to seal the vent 160 and prevent 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 a sample (as described above), the plasma will contact the plug filter 410, thereby making it self-sealing and preventing the plasma from escaping from the vent 160.
In some embodiments, particularly those employing self-sealing plug filters, it may be 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 top cover 120 may have one or more splash guards 430 that protect the plug filter 410 from any splatter or foaming within the plasma container 100 during filling. For example, as best shown in fig. 11A-11C, the splash guard 430 may extend downward from the bottom of the exhaust port skirt 420. One or more splash guards (e.g., a closet 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 while FIGS. 11A-11C illustrate two splatters shields 430, other embodiments may have only a single splatter shield 430 or more than two splatters shields 430.
As best shown in fig. 11A and 11B, the underside 124 of the top cover 120 may have a number of structures that help stiffen the top cover 120. For example, the top cover 120 may include reinforcing ribs 440 on the underside 124 of the top cover 120. The ribs 440 may be asymmetric and irregular to help prevent resonance-induced node vibration in the cap 120 (e.g., securing the cap 120 to the plasma container 100) during the ultrasonic welding process.
Fig. 12A-12E illustrate a top cap 120 of a plasma storage container 100 with an alternative valve mechanism (e.g., needle-free valve). In such embodiments, the cap 120 may include a valve housing 510 extending upwardly from the top surface 122 of the cap 120 in addition to the skirt 190 extending from the underside 124 of the cap 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 interior geometry that meets a standard luer taper (e.g., the inner diameter of the inlet portion 514 may taper so as to meet the luer standard). The inlet 170 may be located at the proximal end of the inlet portion 514 such that when the cannula 240 is connected, a portion of the cannula 240 will enter the inlet portion 514 of the valve housing 510.
The valve housing 510 is positioned below the inlet portion 514 and may include a second/distal portion 516, with the second/distal portion 516 having an inner diameter that is greater than the inner diameter of the inlet portion 514. It is important to note that the larger inner diameter may gradually expand as shown in fig. 12A-12E, or that 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 enlarged diameter portion 516 assists in opening the orifice 210 within the valve mechanism during operation.
The valve member may be an elastomeric element 520 that includes a proximal portion 522 (e.g., a diaphragm) and a valve wall 524, the valve wall 524 extending 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, which distal end 521 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 may include a flange 527 extending radially outward from the distal portion 521 of the valve member 520 and contacting the shelf portion 192 of the skirt 190. Similar to the embodiments described above, the valve member/resilient element 520 may be secured within the cap 120 by a swaged connection (or similar connection). To further support the valve member/resilient member 520 within the inlet housing 510 and to help position the proximal portion 522 at the inlet 170, the valve member/resilient member 520 has a shoulder 523 that contacts an inner surface (e.g., angularly/gradually expands the diameter of the second/distal portion 516) of the inlet housing 510 when the valve mechanism is in a closed mode (e.g., when the cannula 240 is not connected).
During operation (e.g., during connection of cannula 240), a user may insert cannula 240 into inlet 170, and cannula 240 may also have a luer taper on outlet portion 242. 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., as the proximal end portion 522 enters the larger inner diameter portion of the inlet housing 510) to establish 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 nature of the valve member 520 causes the valve member 520 to begin to move proximally within the inlet housing 510 and return to its rest position with the inlet portion 514. This in turn causes the orifice 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. Conversely, as shown in fig. 12E, the outlet portion 242 of the cannula 240 may be sized such 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 would contact only the top surface of the proximal portion 522 of the valve member and would not enter the aperture 210.
As described above, some embodiments may have a retainer/clamp 180 that secures the cannula 240 to the plasma container 100 and prevents the cannula 240 from being accidentally disconnected from the inlet 170 during use. 12A-E, the outer 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 this end, the cannula 240 may include a skirt 241, the skirt 241 having internal threads 243 (e.g., on an inner surface of the skirt 241) that engage threads 515 on the inlet housing 510 (fig. 12E). Inlet threads 510 and threads 243 within cannula skirt 241 may conform to ANSI/ISO standards (e.g., they are capable of receiving/connecting to ANSI/ISO standard-conforming medical devices).
It is important to note that while luer lock threads are discussed above, other embodiments may use other connectors, such as BNC connectors. For example, some embodiments may utilize a connector that locks only partially around the curve. Such a connection may include a radial protrusion (on the inlet housing 510 or cannula 240) that mates with an angled surface (e.g., on the inlet housing 510 or cannula).
Fig. 13A-13C illustrate a cap having a plasma storage container with different mechanisms for connecting the cannula 240 to the inlet 170 of the cap 120. Similar to the cap 120 described above and shown in fig. 4 and 5, the cap shown in fig. 13A-13C may include a diaphragm 200 (e.g., a valve mechanism) positioned 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 aperture 210 (e.g., a normally closed aperture) extending therethrough to allow the cannula 240 to enter the interior of the container 100 when connected. As described above, the aperture 210 may be one or more slits extending through the septum 200, or as shown in fig. 14, may be a pre-punched hole that opens under elastic deformation when the cannula 240 is connected.
To facilitate connection and disconnection of the cannula 240, the cap 120 may have a cannula support structure 710 extending from the top surface 122 of the cap 120 around the inlet 170. The cannula support structure 710 can be cup/U-shaped such that the wall 712 of the structure 710 slopes 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 a cannula support structure 710 (e.g., a top surface 716 of the structure) may act as a camming surface to assist a user in disconnecting the cannula 240 from the cap 120.
Within the interior of the inlet 170, the top cover 120 may have inwardly protruding protrusions 720 (e.g., inlet protrusions) extending from the interior surface of the inlet 170 (fig. 15). During connection of the cannula 240, the protrusions 720 may interact with protrusions 810 on the cannula 240 (fig. 16) to secure the cannula 240 in place. For example, when a 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 additional pressure is applied by the user, the cannula protrusion 810 will snap over the inlet protrusion 720 such that the inlet protrusion 720 resides within the recess 820 on the cannula 240 (fig. 17A/17B). In this regard, the cannula 240 is fully connected as shown in fig. 18, and the aperture 210 in the septum 200 is open to allow fluid (e.g., plasma to be collected in the container 100). In addition, the cannula 240 may not be inadvertently disconnected from the container 100 (e.g., due to an accidental collision, etc.) due to the interaction between the cannula protrusion 810 and the inlet protrusion 720.
Although fig. 15 and 17A/B show inlet projections 720 extending around the entire circumference of inlet 170, in other embodiments projections 720 may extend only around a portion of inlet 170. Additionally or alternatively, some embodiments may include more than one inlet protrusion 720 (e.g., two or more) spaced around the diameter of the inlet 170. Similarly, cannula protrusion 810 and recess 820 may not extend around the entire circumference of cannula 240. In such embodiments, the projections 810 and recesses 820 may extend around only a portion of the circumference and/or there may be a plurality of projections 810 and recesses 820 spaced around the circumference of the cannula 240.
It should be noted that the cannula boss 810 and/or the inlet boss 720 may have features that reduce the force required to connect the cannula 240 and snap the inlet boss 720 onto the cannula boss 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 each other.
As described above, the top surface 716 of the cannula support structure 710 can act as a camming surface that helps to break the cannula 240 apart after fluid collection is complete. To this end, once fluid collection is complete and the user wishes to disconnect the cannula 240, the user may grasp the cannula 240 (e.g., via the body 240 and/or the grasping element 246) and rotate the cannula 240 (e.g., clockwise or counterclockwise) (fig. 19). As 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 snapping the inlet tab 720 over the cannula tab 810 to disconnect the cannula 240 from the inlet 170.
During processing, the user/technician may need to plug various tubing/test tubes within the collection system (e.g., tubing set 300 used during collection or test tubes within other tubing). To this end, some embodiments may incorporate additional clamps within the kit. For example, as shown in fig. 16, 18 and 19, the gripping element 246 may be formed with a tube clamp 248. In use, if a technician wishes to occlude a portion of a test tube, the technician can slide the test tube into the collet 248, which collet 248 in turn deforms and closes the test tube to prevent fluid flow through the test tube.
It is important to note that in some applications it may be beneficial to maintain 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 inlet 170. For example, as shown in fig. 20, the top cover 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 cap 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 may include a pull tab 612 that a user may grasp and pull to peel the barrier 610 from the inlet 170. In embodiments that include a valve housing 510, the cap 120 may alternatively include a removable end cap/cover 620 (fig. 21) located on the valve housing 510 (e.g., on the inlet portion 514). Like the skirt 241 of the cannula 240, the interior of the end cap/cover 620 may include threads (not shown) that thread onto threads on the inlet portion 514.
For embodiments similar to those shown in fig. 13A-13C, the end 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 sterility (see fig. 22-24). The lower portion 910 extending into the inlet 170 may have protrusions that interact with the inlet protrusions 720 in a manner similar to cannula protrusions, and/or the lower portion 910 may be sized such that it is press fit into the inlet 170. On either side of the end cap 900 (or on both sides of the end cap 900), the end cap 900 may 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 may grasp and rotate the end cap 900 to slide the mating portion 930 upward along the top surface 716 (e.g., cam surface) of the support structure 710, disconnecting the end cap 900 from the inlet 170. Alternatively, the user may simply grasp the end cap 900 and pull the end cap 900 from the inlet 170. To facilitate grasping of the end cap 900 by a user during disassembly, the top of the end cap 900 may have a flange 920 extending from the end cap 900.
While the above-described embodiments eliminate ports for introducing plasma into the prior art container and ports for draining the prior art container (e.g., ports extending from the plasma container and tubing segments connected to the ports, as described above), some embodiments may eliminate only a single port (e.g., the container may retain a port). For example, some embodiments may utilize an inlet port 170 and valve member/membrane 200, but retain a vent (e.g., a vent extending from a plasma container and having a tube segment connected thereto). Alternatively, some embodiments may utilize the vent 160 and the hydrophobic membrane 230 (or plug filter 410), but retain a port for introducing plasma into the bottle (e.g., an inlet opening extending from the plasma container and having a tube segment extending therefrom).
It should be noted that the 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 spools and ports described above, some embodiments of the present invention can reduce and/or eliminate the risk of breaking and including product sterility. Furthermore, various embodiments of the present invention can eliminate the need for thermal/RF sealing equipment and processes for sealing pipes prior to shipping and storage. In addition, because embodiments of the present invention allow for sample collection directly through the septum 200 (e.g., as opposed to first pumping plasma into a portion of a tube as in many prior art systems), the present invention is able to collect a highly representative plasma sample with little/no loss.
The embodiments of the invention described above are merely exemplary and the invention is not limited to the disclosed embodiments. Many variations and modifications will be apparent to practitioners 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.
Claims (96)
Applications Claiming Priority (5)
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|---|---|---|---|
| US201862674913P | 2018-05-22 | 2018-05-22 | |
| US62/674,913 | 2018-05-22 | ||
| US16/161,482 | 2018-10-16 | ||
| US16/161,482 US11648179B2 (en) | 2016-05-16 | 2018-10-16 | Sealer-less plasma bottle and top for same |
| PCT/US2019/033518 WO2019226769A1 (en) | 2018-05-22 | 2019-05-22 | Sealer-less plasma bottle and top for same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN112312876A CN112312876A (en) | 2021-02-02 |
| CN112312876B true CN112312876B (en) | 2025-01-03 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201980041297.7A Active CN112312876B (en) | 2018-05-22 | 2019-05-22 | Plasma bottles without seals and their caps |
Country Status (5)
| Country | Link |
|---|---|
| EP (2) | EP4374843A3 (en) |
| CN (1) | CN112312876B (en) |
| AU (1) | AU2019272750B2 (en) |
| HU (1) | HUE067821T2 (en) |
| WO (1) | WO2019226769A1 (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4508236A (en) * | 1982-09-13 | 1985-04-02 | Baxter Travenol Laboratories, Inc. | Container and associated cap assembly for plasma collection and the like |
| US6221041B1 (en) * | 1997-11-26 | 2001-04-24 | Eurospital S.P.A. | Fluid transfer device connecting a medicinal vessel and an IV bag in closed system |
| WO2017200992A1 (en) * | 2016-05-16 | 2017-11-23 | Haemonetics Corporation | Sealer-less plasma bottle and top for same |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2447691A (en) * | 1947-02-17 | 1948-08-24 | Baxter Don Inc | Device for packaging and dispensing intravenous solutions |
| US4744785A (en) * | 1984-10-02 | 1988-05-17 | C. R. Bard, Inc. | Autotransfusion system |
| IE66526B1 (en) * | 1989-03-17 | 1996-01-24 | Baxter Int | A pre-slit injection site usable with a blunt cannula |
| CA2185494A1 (en) * | 1995-09-27 | 1997-03-28 | Jean-Pierre Grimard | Resealable vial with connector assembly having a membrane and pusher |
| US6391014B1 (en) * | 1996-12-20 | 2002-05-21 | David G. Silverman | Strong diaphragm/safe needle/converting device combinations and their individual components |
| US6908459B2 (en) * | 2001-12-07 | 2005-06-21 | Becton, Dickinson And Company | Needleless luer access connector |
| DE102007005407A1 (en) * | 2007-02-03 | 2008-08-07 | Fresenius Kabi Deutschland Gmbh | Cap for a container for holding medical fluids and container for receiving medical fluids |
| DE202011052056U1 (en) * | 2011-11-22 | 2011-12-30 | Deutsche Gesellschaft für Humanplasma mbH | Blood plasma collection bottle |
| CN104869972A (en) * | 2012-12-21 | 2015-08-26 | 费森尤斯卡比德国有限公司 | Milk bottle adapter |
| BR112015026154B1 (en) * | 2013-04-15 | 2022-05-10 | Becton, Dickinson And Company | Interlockable biological fluid sampling device with a separate vascular access device and biological fluid collection and sampling assembly |
| BR112017007237B1 (en) * | 2014-10-15 | 2020-12-01 | Merck Patent Gmbh | sample preparation container |
-
2019
- 2019-05-22 EP EP24170321.4A patent/EP4374843A3/en active Pending
- 2019-05-22 EP EP19807135.9A patent/EP3796884B1/en active Active
- 2019-05-22 HU HUE19807135A patent/HUE067821T2/en unknown
- 2019-05-22 WO PCT/US2019/033518 patent/WO2019226769A1/en unknown
- 2019-05-22 AU AU2019272750A patent/AU2019272750B2/en active Active
- 2019-05-22 CN CN201980041297.7A patent/CN112312876B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4508236A (en) * | 1982-09-13 | 1985-04-02 | Baxter Travenol Laboratories, Inc. | Container and associated cap assembly for plasma collection and the like |
| US6221041B1 (en) * | 1997-11-26 | 2001-04-24 | Eurospital S.P.A. | Fluid transfer device connecting a medicinal vessel and an IV bag in closed system |
| WO2017200992A1 (en) * | 2016-05-16 | 2017-11-23 | Haemonetics Corporation | Sealer-less plasma bottle and top for same |
Also Published As
| Publication number | Publication date |
|---|---|
| HUE067821T2 (en) | 2024-11-28 |
| CN112312876A (en) | 2021-02-02 |
| AU2019272750B2 (en) | 2024-10-10 |
| EP4374843A3 (en) | 2024-08-07 |
| EP4374843A2 (en) | 2024-05-29 |
| EP3796884A4 (en) | 2022-03-09 |
| EP3796884B1 (en) | 2024-04-17 |
| EP3796884A1 (en) | 2021-03-31 |
| WO2019226769A1 (en) | 2019-11-28 |
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