Valve, method of manufacturing the valve, cap for a fluid container with such a valve, fluid container with such a cap, and method of manufacturing such a cap

Abstract

The valve (5) comprises a valve housing (51) and a resilient valve member (52) received within the valve housing (51) and configured to close the valve (5) when the valve (5) is in a closed operational state. The valve member (52) includes a valve opening (522). The valve opening (522) is configured to be closed when the valve (5) is in the closed operational state and to provide a fluid passageway through the valve (5) when the valve (5) is in an open operational state. The valve member (52) is overmolded within the valve housing (51). The valve is beneficially used as a valve element for a port in a cap of a fluid container, particularly a medical fluid container.

Description

[Technical field]

[0001] The present invention relates to a valve, a method for manufacturing a valve, a cap for a fluid container equipped with such a valve, a fluid container equipped with such a cap, and a method for manufacturing such a cap. [Background technology]

[0002] Valves usually have the function of controlling the flow of fluids through ducts, conduits, etc. Valves are used in various devices, including medical devices. Here, valves placed at connection points of medical devices and containers play a major role. Such connection points, generally also called "ports", are used to connect fluid transfer devices, whereby a fluid connection can be established between the device or the container, respectively, and the fluid transfer device. Such valves may have the purpose, among others, of closing the port when the fluid transfer device is not connected to said valve, preventing uncontrolled entry or exit of fluid. Among other functions, such valves may also serve to establish a fluid connection between the device or the container, respectively, and the fluid transfer device, and to hold the fluid transfer device in place when connected to the device or container. Valves are used in various devices in the medical field and other fields. Thus, the valve according to the invention is not limited to valves of medical devices and containers. In the field of medical applications, the valve according to the invention may be used, for example, in a wide variety of containers, infusion sets for infusions or blood transfusions, transfer devices, etc. Many other applications are possible in the medical field and other fields as well. Applications for the valve according to the invention can be found, for example, in the field of laboratory equipment and in other scientific and technical fields. The valve according to the invention can also be used in personal devices.

[0003] Valves are used, for example, in devices for administering infusions or blood transfusions, and may also be installed at ports of containers that hold liquids to be used for infusions or blood transfusions.

[0004] For therapeutic purposes, infusions and blood transfusions are used in human and veterinary medicine. For example, intravenous infusions are used to administer liquids (e.g., solutions of active substances or other liquid medicines) into a patient's bloodstream. For this purpose, the liquid to be administered is taken from a liquid container and flows through an infusion tube into an intravenous access. The intravenous access is provided, for example, by a peripheral cannula inserted into the patient's median cubital vein. Through that venous access, the infusion enters the patient's bloodstream.

[0005] An intravenous administration set (also known as an "IV administration set," "IV administration set," "IV set," "intravenous set," "infusion set," etc.) includes flexible tubing through which fluid can flow from a container to an intravenous access. An intravenous administration set is a typical example of an administration device, i.e., a device used to administer therapeutic fluids to a patient. Intravenous administration sets often (but not necessarily) include a drip chamber connected to the tubing, thereby allowing the fluid to flow from the container through the drip chamber and into the tubing. Intravenous administration sets may optionally include additional components, such as a flow regulator, such as a roller clamp, to control the flow rate of liquid.

[0006] If a drip chamber is present, it is connected to a container via a container connection so that liquid can flow from the container into the drip chamber, otherwise the tube is provided with a container connection directly.

[0007] The vessel connector may be a piercing device, such as a hollow mandrel, capable of penetrating a septum of the vessel and having one or more fluid channels therein. Such a piercing device is commonly referred to as a "piercing spike" or "spike."

[0008] A "septum" is a closure of a container or device in the form of or including a membrane. The membrane is a rubber membrane, a membrane made of other suitable elastic material, or possibly a thin membrane made of hard plastic similar to that used for the container or device. In many cases, the membrane has the form of a disk inserted into an opening in a housing. The membrane is pierced with a hollow piercing device to remove fluid from the container or to introduce fluid into the interior of the container. The piercing device can be the above-mentioned spike, a syringe needle, etc. Preferably, the membrane is self-sealing, i.e. when the piercing device is withdrawn from the membrane, the opening pierced by the piercing device, i.e. the puncture hole, closes at least partially, preferably completely. Septum membranes usually do not have a pre-made opening in the form of a hole or slit through which the piercing device is inserted.

[0009] By "fluid" is understood a flowable substance, in particular a liquid or a suspension.

[0010] Fluid access of a container or other device is generally referred to as a "port" in the context of medical fluid technology. Thus, a port is a connection site to which a fluid handling device can be connected to establish a fluid connection between the interior of the container or device and an external device for fluid extraction or fluid addition (hereinafter referred to as a "fluid handling device"). Note that among containers used for infusion and blood transfusion therapy, the port to which an intravenous administration set is connected is called an "administration port."

[0011] A medical fluid container is a container intended to contain medical fluids, including liquid therapeutic or diagnostic medicines, liquid pharmaceutical ingredients, nutrients, blood for transfusions, etc., and is made of a material suitable for this purpose.

[0012] The fluid container, from which the fluid to be administered is taken, may be a bottle made of a rigid material such as glass or rigid plastic. Plastic bottles and bags with a certain degree of flexibility are also becoming established on the market. Plastic not only has the advantage of being less fragile than glass due to its low specific gravity. If a sufficiently flexible plastic is used, it also has the advantage that the container will collapse when the liquid is removed. This means that the volume of the container will continuously adapt to the decrease in the volume of liquid inside it, and no additional pressure balancing means in the form of air inlet channels or air inlet openings are required. This not only simplifies the design of the administration device, but also avoids the risk of contamination of the inside of the container by incoming air.

[0013] Some commercially available containers containing liquids for intravenous administration allow the addition of other drugs (so-called "drug mixing"). For example, drug mixing is performed by injecting the drug through a further port (so-called "medication port") of the container containing a septum. That is, the drug is injected by a syringe equipped with a hollow needle, which penetrates the septum. In the case of a flexible bag, the medication port and the administration port are provided separately and individually attached to different positions of the bag, or are provided in an integrated port, the relative position and distance between the administration port and the medication port being defined by design. In the case of a bottle, there is usually only one opening (the so-called bottleneck), so the administration port and the medication port are usually provided in an integrated port. Due to the limited size of the opening (usually limited by the process used to mold the container), the dimensions of the port are smaller than can be designed for the bag, resulting in the medication port being located closer to the location of the administration port. This makes it easier to manufacture the container, but makes it more difficult, or even impossible, to connect a syringe or other fluid handling device to the medication port and simultaneously connect a piercing spike or other piercing device to the administration port.

[0014] Infusion containers made of polyolefin materials are commercially available. These containers have a cap at the top of the container. During infusion, the container faces downwards. According to some embodiments, the cap can have a single septum with identified puncture points, for example as described in the international standard ISO 15759. The cap can have two ports adjacent to each other. The two ports can be of the same design, in which case the cap is commonly called a "twin port cap". Each port is provided with a septum that can be pierced by the spike of an intravenous administration set or the needle of a syringe. The user can intentionally select which of the two parts is used as an administration port and which is used as a medication port. According to further embodiments, it is also possible that one of two functionally identical or functionally equivalent ports is intended as an administration port and the other is intended as a medication port. The different intended uses can be indicated by using labels, symbols, different colors, etc. According to further embodiments, it is also possible for the cap to have two partitions that differ from each other in terms of material or design, as shown for example in US 2009 / 0054865 A1. In this case, the functionality of the administration port may differ from that of the medication port in such a way that the design and / or material can be adjusted to the specific needs of the port. Possibly, the administration device and / or the connection with the medication device may be intentionally limited in design to only one port that corresponds to a specific application (withdrawal of the medication liquid for administering the medication liquid to the patient, or connection to a transfer device for reconstitution and / or connection of the medication liquid). For practical reasons, the caps used for bottle-like medical containers have a limited size, which makes simultaneous connection of the medication and the administration device difficult or impossible with known caps.

[0015] Injecting liquids into containers using syringes can be cumbersome, since appropriate needles must be stocked, unpacked and connected to the syringe before use, and discarded after use. Furthermore, piercing the container port with a needle is prone to mishandling. In particular, if the piercing direction is not perpendicular to the septum, the needle may be bent and damaged, and / or the septum may not completely seal after the needle is withdrawn, and / or the needle may pierce the port and / or the side wall of the container. Furthermore, handling of the needle carries a potential risk of injury. If drug mixing is performed during infusion, the port for injecting the mixed drug may be difficult to access if the container is hung upside down. Also, the needle is only held at the piercing area via contact with the septum material, which may lead to inadvertent withdrawal or dislodging of the needle or syringe.

[0016] From DE 10 2007 005 407 A1 a cap for a container for medical liquids is known. The removal part has a pierceable membrane, through which a spike of an intravenous administration set can be pierced in the traditional manner. The infusion part is designed to receive a male cone of a syringe. The infusion part does not have a septum but has a slit valve, i.e. a membrane with a slit that is opened by an inserted male syringe cone. The slit valve is provided by a membrane inserted in the removal part.

[0017] From US 6,866,656 B2 a medical device is known with a luer connector for needleless connection with a male luer fitting such as a syringe. The connector comprises a housing having an upper part and a lower part, with an elastic member inserted in a cavity between the upper and lower parts. The elastic member comprises a top disc and a bottom disc connected to each other by a substantially flat joint. The discs and the joint are interrupted by a slit through which the male luer fitting is inserted. The elastic member is fixed in place by using a mechanical structure or an adhesive.

[0018] The manufacture of such a mixing part or luer connector is time-consuming and costly, since it involves the manufacture of the device body with the valve seat by a first machine, the manufacture of the membrane or elastic member by another machine, and the insertion of the membrane or elastic member into the valve seat by a further machine. Moreover, the insertion of the membrane or elastic member has the risk of damage due to the deformation of the necessary elastic material. Moreover, when the membrane or elastic member is inserted, particles of it may break or crumble. Such particles must be cleaned off in an additional step, since they may otherwise cause contamination and / or enter the patient's bloodstream. Moreover, since the wall of the housing and the elastic member are only in contact with each other, there is a gap between the elastic member and the wall of the housing. The presence of a gap not only causes the possibility of leakage, but also makes disinfection difficult and may even lead to the ingress of further impurities during use. This situation occurs especially when a part of the slit valve deforms, folds back or rolls into itself after the cone of the syringe is inserted into the slit of the valve and then removed from the valve. In such a case, the gap widens, making it easier for, for example, liquid to enter. As a result, there is an increased risk of bacteria, endotoxins, disinfectants, etc. accumulating and contaminating the liquid prior to administration to the patient, which may pose a serious health hazard. Furthermore, as mentioned above, the membrane or elastic member is inserted into a recess, i.e. there is only a form-fit connection. However, since the membrane or elastic member must have a certain elasticity to perform their function, there is a risk that the membrane or elastic member will be inadvertently pushed out of the valve seat when the syringe cone is inserted. This makes the valve unusable.

[0019] Thus, like the luer connector according to US 6,866,656 B2, the cap of DE 10 2007 005 407 A1, in particular the mixing part (slit valve), is difficult to clean and disinfect. Moreover, since the mixing part and the removal part of the cap according to DE 10 2007 005 407 A1 are close to each other and point in the same direction, it is difficult or impossible to mix drugs and administer liquids intravenously at the same time, especially since the connected devices (IV set and syringe) will be aligned in a direction determined by the respective rigid openings of the ports. For example, a user may have to position the syringe, for which he wishes to supply liquid with the syringe via the mixing part, at an oblique angle (for which the membrane of the mixing port is not designed). Moreover, the shape of the rigid housing around the membrane is intended to guide the conical tip of the syringe, so that the syringe cannot be connected in a direction other than that of the main axis of the administration port without risking damage to the administration port and / or the syringe. As a result, leakage may occur which may lead to contamination of the sterile product. In this case, the aforementioned problems become more severe. Moreover, according to DE 10 2007 005 407 A1, the openings of the administration and removal parts are sealed by break-off parts which are complex to manufacture and cumbersome to handle. Summary of the Invention [Problem to be solved by the invention]

[0020] In view of the above situation, it is an object of the present invention to provide an improved valve, in particular an improved valve with respect to at least one of the above-mentioned characteristics of prior art valves, a method for manufacturing the improved valve, an improved cap for a fluid container, an improved fluid container, and a method for manufacturing the improved cap. [Means for solving the problem]

[0021] This object is achieved by a valve according to claim 1, a method for producing a cap according to claim 8, a cap according to claim 9, a fluid container according to claim 14 and a method for producing a cap according to claim 15. Improvements of the invention are specified in the dependent claims. Any feature defined in a claim dependent on any independent claim may be understood as a feature suitable for improving the valve, the cap, the fluid container and the method together with any feature defined in the following description of exemplary embodiments of the invention.

[0022] A valve according to the present invention comprises a valve housing and a resilient valve member received within the valve housing and configured to close the valve when the valve is in a closed operational state, the valve member including a valve opening configured to be closed when the valve is in a closed operational state and to provide a fluid passageway through the valve when the valve is in an open operational state, i.e. after a male connector, such as the tip of a corresponding fluid handling device, is inserted into the valve opening (52).

[0023] The valve member is overmolded into the valve housing, and the valve opening, e.g., a slit through the material of the valve member, may be formed during the injection molding process or in a separate step, such as cutting with a lubricated blade.

[0024] The presence of a lubricant in the slit may have the added benefit of reducing or avoiding self-healing of the material during sterilization, shipping, storage, or unintentional bonding of cut edges. The presence of a lubricant in the slit may have the added benefit of simplifying insertion of the male connector.

[0025] In particular, the valve is in a closed operational state when no fluid handling device is connected to the valve, and is in an open operational state when a suitable fluid handling device, such as a syringe, is connected to the valve.

[0026] Preferably, the resilient valve member comprises or consists of an elastomeric material.

[0027] Preferably, the distal surface of the valve member is flat or substantially flat, filling the entire opening of the valve housing and forming a disk-shaped portion. More preferably, a further portion of the valve member extends inside the valve housing along a major axis of the valve housing and may have a substantially circular, elliptical or substantially rectangular cross section. The portion may reach and be connected to at least a part of the inner wall of the valve housing or may have a certain distance relative to the inner wall of the valve housing, at least in a closed operating state of the valve.

[0028] More preferably, the slit extends through the distal disc-shaped portion and the inwardly projecting portion to provide a fluid passageway once the valve is in an open operating condition.

[0029] To manufacture the valve by overmolding, the valve housing is preferably molded first. In a second step, the valve member, made of a softer material, is injection molded into the already manufactured valve housing, which is placed in an injection mold (which may have an insert specially designed for molding the valve member). In some areas, the material used to mold the elastic valve member reaches the inner wall of the valve housing in a hot molten state and is bonded to the valve housing by material fusion, so that no gap remains between the elastic valve member and the valve housing in those areas. Such a bond is formed at least around the distal disc-shaped portion of the valve member, so that the valve member remains in a fluid-tight connection with the housing even when a fluid handling device is connected to the valve. The reason that the housing is molded first is because it is made of a harder material and can withstand the pressures and temperatures that occur during the injection molding of the valve member. Conversely, if the valve member is molded before the valve housing, the valve member may not be able to withstand and may become deformed. Therefore, the molding sequence of the different parts can be a key factor in achieving a robust process and obtaining accurate, repeatable and functional parts.

[0030] Due to the absence of gaps between the valve member and the valve housing at the distal end, the risk of leakage is reduced or even avoided. Due to the absence of gaps, the risk of contamination is also reduced or even avoided. In other words, the valve according to the invention is easier to clean and disinfect and less prone to build up of contaminants than conventional valves with elastic valve members that move inwardly into the valve housing when connecting a fluid handling device. As a result, the risk of contamination of the infusion with bacteria, endotoxins, disinfectants, etc. prior to administration of the infusion can be reduced or avoided. Furthermore, due to the strong adhesion, the risk of the valve member being inadvertently detached from the valve housing when a syringe cone or the like is inserted can be reduced or avoided.

[0031] The lack of gaps between the valve member and the valve housing reduces the likelihood of bacteria and other contaminants building up, and it may even be possible to produce a clean, sterile valve without the additional step of sterilization using radiation.

[0032] In the valve according to the invention, the number of pre-assembled parts is reduced compared to conventional valves, which reduces the number of assembly steps and operations, which on the one hand increases the efficiency of the manufacturing process, which on the other hand may reduce the risk of defects and / or contamination of the components.

[0033] It is also possible to use valve members made from thermoplastic elastomers, which have excellent material properties and are often recyclable.

[0034] An overmolded seal member can be distinguished from a seal member that is attached, for example, in a press-fit or form-fit manner, in that the material of the overmolded seal member and the material of the housing are bonded to one another at the contact areas, providing a tight, gap-free connection.

[0035] An overmolded seal member can be distinguished from a seal member secured to the housing with an adhesive in that there is no adhesive between the material of the overmolded seal member and the material of the housing.

[0036] Compared with standard designs, the valve according to the preferred embodiment of the present invention does not include any part that folds back or rolls on itself when connecting with a male connector. Therefore, only easy-to-clean and sanitize surfaces come into contact with the fluid passage. Therefore, it is easy to efficiently clean and / or sanitize the valve prior to connection with a fluid handling device. In standard designs, the entire elastomeric member is compressed downward into the valve housing, which creates gaps. Such gaps are difficult to clean and sanitize.

[0037] Furthermore, the valve according to the invention is less time-consuming and less costly to manufacture, since forming the valve member and positioning it in the right position can be achieved in one step by overmolding, thereby avoiding the cumbersome step of inserting a pre-manufactured valve member, and as a result, the risk of damage to said valve member due to deformation caused by inserting a pre-manufactured elastic valve member into the valve seat is also avoided.

[0038] Another advantage of the overmolding process is that no glue or the like is required to join the valve member and the valve housing. Thus, the valve according to the invention can be easily integrated into a container for a pharmaceutical solution that must have a very low level of potential extractables and leachables during the entire shelf life of the product. Pharmaceutical products are generally intended to be stored for several years and are often sterilized at the end of the manufacturing process to meet sterility requirements. Both temperature and time can increase the amount of leachables and cause chemical reactions between chemical components present in the material of the valve parts and the filled pharmaceutical solution. It is therefore advantageous to assemble the valve without any additional materials other than the constituent parts of the valve.

[0039] Valves according to the present invention may also be implemented in medical devices such as IV lines, transfer devices, vial adapters, etc. Although the requirements for extractables and leachables are less stringent, particularly since these have a very short contact time with the fluid, typically on the order of minutes to days, reducing the leaching of chemical components into a pharmaceutical solution reduces the toxicological risk to patients who may ultimately receive the pharmaceutical solution.

[0040] Manufacturing the valve according to the invention by overmolding instead of using solvents and / or adhesives also has the advantage that there are fewer and less expensive parts to be handled and further processed, which leads to a reduced risk of errors in the manufacturing process (molding of components and assembly of components), thus reducing the material and process costs of the subject invention, making it a cost-competitive alternative to current manufacturing processes that include adhesive steps.

[0041] Preferably, the cross section of the valve member in a plane perpendicular to the extension of the slit and parallel to the connection direction has a T-shape or other shape that ensures that the slit is partly by two relatively thin walls, in particular substantially or entirely flat walls, in which case pressure applied to the inside of the valve for example presses the two walls together, which may further improve the mechanical fit and the seal.

[0042] The connection of the fluid handling device may be made as follows: During connection of a fluid handling device, the tip of the device is initially pressed against the outer surface of the distal portion of the valve member (preferably the distal disc-shaped portion), causing this portion to deform in a bowl-like shape towards the inside of the valve. In the next step, as more force is applied and the elongation of the disk is limited by material properties, the slit walls begin to move away from each other, allowing space for the device tip to pass through the slit. In a further step, the device tip is forced through the slit (the interior walls of which correspond to the outer shape of the device tip) in a manner that establishes a fluid connection throughout the elastomeric valve member. Due to the intimate contact between the inner wall of the slit and the tip of the device, the fluid cannot leak along the tip of the device, but only through the bore of the tip of the device.

[0043] When the fluid handling device is disconnected, the elastomeric valve member relaxes, causing the inner walls of the slit to re-contact and close the fluid passageway to prevent leakage, but allowing further connection if required for subsequent fluid transfer.

[0044] According to further embodiments, additional elastic structures are provided, in particular radially extending elastic structures added between the inwardly projecting portion of the valve member and the inner wall of the valve housing. These structures support a tight connection with an inserted male connector and / or a tight closure after withdrawal of the male connector, in particular helping the slit to close faster during withdrawal of the fluid handling device. These elastic structures can be formed, for example, by ribs exerting an elastic force that keeps the opening tightly closed when no male connector is present and presses the inner wall of the opening tightly against the male connector when the male connector is in the opening.

[0045] Preferably, the material of the valve member is selected to ensure: (1) easy connection with the male connector; (2) sufficient force to cause the valve member to return to its original shape when the male connector is removed; (3) resilience, i.e., minimal change in material properties even after repeated connections of the male connector; and (4) high tear resistance so as not to tear upon insertion of the male connector.

[0046] Since the elastomeric valve member is overmolded to the valve housing and bonded thereto during the process, thermoset materials are not suitable and thermoplastic materials are preferred. In a preferred embodiment, the valve member comprises at least one thermoplastic elastomer, more preferably at least one polymer selected from the group consisting of styrenic block copolymers, thermoplastic polyolefin elastomers, thermoplastic vulcanizates, thermoplastic polyurethanes, thermoplastic copolyesters, and thermoplastic polyamides.

[0047] Additionally or alternatively, in a further preferred embodiment, the valve member comprises a resilient material having a hardness between 25 and 55 Shore A.

[0048] Additionally or alternatively, in a further preferred embodiment, the valve housing comprises a polyolefin, preferably at least one of polypropylene and polyethylene, and / or at least one of engineering plastics, preferably polyamide, polycarbonate and polystyrene, where polyolefins are particularly preferred when the valve is used, for example, as an element of a cap for a medical liquid container to be used for infusion therapy, since polyolefins generally exhibit a cleaner extractables profile, are relatively insensitive to organic solvents commonly used as disinfectants, and are less susceptible to stress corrosion cracking than amorphous materials.

[0049] Additionally or alternatively, in a further preferred embodiment, said body comprises a polymeric material having a tensile and / or flexural modulus of at least 700 MPa.

[0050] Preferably, the valve member is configured to provide a fluid-tight connection with a liquid-handling device, more precisely with the male connector of said device, whereby fluid can flow through the valve exclusively via the connector of the liquid-handling device, in other words the connection between the fluid-handling device and the valve is fluid-tight in the absence of leakage, i.e. the material around the valve opening is tight against the outer surface of the connector of the fluid-handling device.

[0051] Additionally or alternatively, the valve opening is preferably a self-sealing valve opening, i.e. the valve closes automatically after the connecting part of the fluid handling device (male connector, e.g. syringe cone) is removed. Such a self-sealing valve opening may also be called a "resealing valve opening."

[0052] In particular, the valve opening is formed as a self-sealing channel for a male connector, such as a syringe cone. This is preferably achieved by a slit formed in the valve member. Here, the slit can be designed in such a way that it tightly connects to any subpart of the ISO 80369 series of standards, in particular to a male luer connector according to ISO 80369-7 or to a male connector according to ISO 80369-6. The connection system according to ISO 80369-6 is also called NRFit®. Designing the slit according to a connection geometry according to a given standard means that the valve is adapted to receive a male connector having dimensions defined in the standard, such that a safe fluid connection is established. This ensures compatibility with common medical devices.

[0053] Preferably, the outer surface of the valve member is substantially flush with, completely flush with, or projects beyond an edge surface of the valve housing.

[0054] The outer surface of the valve member is the surface that faces towards the outside of the device or container of which the valve may be a part, i.e. the surface where the fluid handling device is connected to the valve. The outer surface is sometimes also referred to as the "distal surface" of the valve member.

[0055] The terms "distal" and "proximal" mean closer or further from the interior of a device or container of which the valve may be a part. In a preferred embodiment, the valve is part of a container cap, the body of the cap having a hat-like structure. The concave side is also referred to as the "proximal side" or "inner side" (i.e., the side that faces the interior of the container when the cap is connected to the container body). The convex side is also referred to as the "distal side" or "outer side". Similarly, the body surface on the concave side is also referred to as the "proximal face" or "inner face", etc.

[0056] The edge surface is that surface of the valve housing that defines the distal opening of the cavity into which the valve member is overmolded.

[0057] In preferred embodiments, the distal surface of the elastomeric valve member is flush or substantially flush with the distal end of the valve housing, i.e., the distal surface of the elastomeric valve member transitions completely or substantially smoothly into the edge surface of the valve housing.

[0058] The outer surface of the valve member is perfectly flush with the edge surface of the valve housing if the two surfaces meet continuously, whereby no step is formed in the area where the surface of the valve member meets the surface of the valve housing along the entire circumference of the valve member. This means that the outer surface of the valve member and the edge surface of the valve housing are aligned. In other words, this means that the outer surface of the first seal member smoothly transitions into the edge surface of the first port housing. The outer surface of the valve member is substantially flush with the edge surface of the valve housing if a step of 1 mm or less, preferably 0.5 mm or less, more preferably 0.25 mm or less, most preferably 0.1 mm or less is formed. In other words, the outer surface of the valve member is perfectly flush with the edge surface of the valve housing if neither the outer surface of the valve member nor the edge surface of the valve housing protrudes or recedes relative to the other surface. The outer surface of the valve member is substantially flush with the edge surface of the valve housing, provided that one of the surfaces in question protrudes or recedes with respect to the other by a small offset (1 mm or less). It is also possible for the surfaces to mate continuously with one another, but not along the entire circumference, but only along at least 80%, preferably at least 90%, more preferably at least 95% of the circumference of the first seal member. This condition may also be referred to as "substantially flush".

[0059] According to a preferred embodiment, the outer surface of the valve member is substantially flush or completely flush with the edge surface of the valve housing. Such alignment of the outer surface of the valve member with the edge surface of the valve housing makes the disinfection process of the valve member easier and safer. Since the area to be disinfected does not have significant discontinuous surface structures such as steps, effective disinfection can be achieved by application of a disinfectant by rinsing, spraying, wiping, or other application techniques. The disinfectant can efficiently reach the entire area to be disinfected. This prevents the accumulation of pathogens and other contaminants at surface discontinuities, thus preventing the accumulation of contaminants that cannot be effectively or at all removed by application of a disinfectant. Furthermore, cavities in which disinfectant solution can accumulate after application are avoided. Such an accumulation of disinfectant solution ("disinfectant solution pooling") is undesirable when using a valve, since after disinfection, it is necessary to wait for the disinfectant solution to evaporate before connecting a fluid handling device to the valve, or there is a risk that the disinfectant solution will be carried through the septum with the piercing device and enter the patient's bloodstream. Moreover, other debris (especially non-evaporable materials such as various particulate matter, pathogens, dirt, dead organisms, etc.) may be carried through the valve with the male connector of the fluid handling device and may thus enter the patient's bloodstream. Furthermore, disinfection performed during the manufacturing process of the cap or a container equipped with such a cap may be easier or more efficient due to this alignment of the outer surface and the edge surface of the valve member. Furthermore, a fast evaporation of disinfectant is beneficial in terms of manufacturing time, which may avoid the disinfectant being trapped between the valve and the sealing foil applied thereon after disinfection. Disinfectants are usually organic solvents such as ethanol or isopropanol. Such organic solvents may damage the valve, especially if they are trapped between the valve and the foil. Also, due to the total or substantially flush alignment, shadow areas are avoided or minimized, so that a faster and more efficient radiation-based disinfection may be achieved.

[0060] With regard to disinfection efficiency, it is preferred that the outer surface of the valve member and the edge surface of the valve housing are arranged in a perfectly flush manner. However, only a substantially flush arrangement with a small offset, for example 0.1 mm to 0.2 mm, may be sufficient or even preferred with regard to the robustness of the overmolding process. Such a small offset, if any, may be tolerated with regard to disinfection efficiency.

[0061] Preferably, the valve opening is resealable, i.e. after removal of the fluid handling device, the valve opening closes automatically, whereby the resilient valve member again seals the valve opening in a fluid-tight manner.

[0062] According to another preferred embodiment, the outer surface of the valve member protrudes beyond the edge surface of the valve housing, more preferably by 0.1 mm to 1.0 mm. As explained in relation to the flush alignment, providing such a protrusion avoids convex structures such as recesses around the valve opening, thus achieving a comparable disinfection efficiency.

[0063] The method for manufacturing a valve according to the invention comprises the following steps: A) manufacturing or providing a valve housing; B) overmolding a resilient valve member within the valve housing; D) Optionally, placing a release foil on top of said valve member.

[0064] Preferably, in step A, said valve housing is manufactured by moulding, in particular by injection moulding.

[0065] According to a preferred embodiment, the method includes the additional step of cutting a slit in the valve member, preferably with a lubricated blade.

[0066] In particular, the valve according to the invention is manufactured in this way.

[0067] A conventional method of manufacturing a valve having a resilient member with a valve opening involves manufacturing the valve housing on a first machine, manufacturing the resilient valve member on a second machine, and inserting the valve member into a recess in a body on a third machine. This is time consuming and costly. Furthermore, inserting the valve member carries a risk of damaging the valve member due to the deformation required for the insertion.

[0068] Compared to conventional methods, the method of the present invention is more time-efficient and more cost-effective since the valve member is formed in situ by overmolding and does not require a separate step for its insertion. Furthermore, the risk of damaging the valve member is reduced by using the method according to the present invention. Therefore, the present invention reduces the occurrence of defects and strengthens product liability.

[0069] The cap according to the present invention is a cap for a fluid container. In particular, the cap is a cap for a container for medical fluids. The cap comprises (i) a body, (ii) a first port, and (iii) a second port. The body comprises a container connection portion adapted to be tightly connected to a container opening of a container body. The first port comprises a port housing. The first port further comprises an elastic sealing member, the elastic sealing member being received in the port housing and tightly closing the port housing. The cap further comprises a second port. The second port comprises a valve according to the present invention.

[0070] Preferably, the resilient sealing member includes or is made of an elastomeric material.

[0071] The cap is intended to be connected to a container body, i.e. a hollow body with an opening, such as a bottle. Although a bottle or the like may be called a container, in the context of the present invention, the term "container" is used for capped devices, and is therefore referred to herein as a "container body". The assembly of the container body and the cap connected to the container body is therefore referred to as a "container" or "fluid container". To connect the cap to the container body, the container connection part of the cap is connected to the opening of the container body, which is referred to as the "mouth". The connection between the cap and the container body may be achieved, for example, by fastening the connection part of the cap to a wall part of the container body that defines the mouth, such as a neck part. Various techniques may be used to connect the cap to the container body, such as, for example, welding, gluing and / or screwing. The mouth allows access to the interior of the container body. Apart from the mouth, the container body may include further access sites. The shape of the container connection part of the cap and the part of the opening of the container body are complementary, whereby a fluid-tight connection preferably exists between the container and the cap.

[0072] The connecting part of the cap may be fixed to an intermediate part, in particular a molded transition part, connected to the container body. For example, such a transition part may be connected on one side to the flexible bag and on the other side to the cap. The cap may have on one side a substantially oval connecting part intended to be welded to the base port with a matching receiving distal part, and on the other side an almond-shaped proximal part to be welded to the inside of the plastic film of the bag.

[0073] Preferably, the elastic sealing member of the first port is formed as a puncturable septum. A septum is a closure that typically comprises an elastic material such as rubber or other elastomeric material. The septum can be pierced (i.e., penetrated) by a piercing device, such as a hollow spike of an infusion set. Such a piercing device may also be called a "puncture device." The septum seals the first opening. That is, under normal use conditions, if the septum is not pierced by a piercing device, fluid will not flow through the first opening. If the septum is pierced by a hollow piercing device, fluid can flow through a channel in the hollow piercing device. Here, the material of the septum at the piercing site is preferably in close contact with the outer surface of the piercing device. Thereby, fluid does not flow alongside the piercing device, but exclusively through the channel of the piercing device. Preferably, the septum is self-sealing. That is, at least when the septum is pierced by a piercing device up to a certain maximum diameter, the channel formed in the material of the septum by the piercing device will automatically close after the piercing device is withdrawn from the septum. This self-sealing feature may be achieved, for example, by selecting an appropriate elastic material. The self-sealing property may also be referred to as "resealability."

[0074] In particular, said first port is an administration port, wherein preferably said elastic sealing member is adapted to be pierced by a spike of an administration device selected from the group consisting of an infusion set, a blood transfusion set and a transfer device, such that a fluid connection is provided between the interior of the fluid container and the administration device, more preferably said infusion set is an infusion set according to ISO 8536-4, said blood transfusion set is a blood transfusion set according to ISO 1135-4 and said transfer device is a transfer device according to ISO 22413. This ensures that the cap is particularly suitable as a cap for a fluid container for infusion or blood transfusion therapy using conventional devices such as conventional infusion sets.

[0075] The second port constituting the valve according to the invention is a needleless port, preferably a medication port adapted to provide a fluid connection between the interior of a fluid container and a fluid handling device, preferably a syringe with a male connector, more preferably a male connector according to any subpart of the ISO 80369 series of standards, most preferably a male luer connector according to ISO 80369-7 or a male connector according to ISO 80369-6. This ensures that said cap is particularly suitable as a cap for fluid containers for infusion or transfusion therapy with the possibility of drug co-infusion using conventional fluid handling devices such as conventional syringes without needles.

[0076] Alternatively or additionally, the valve housing is integrally formed with the body, which simplifies manufacture and ensures that the valve housing is securely fixed so that it does not inadvertently become detached from the remainder of the body.

[0077] Alternatively or additionally, the administration port housing is integrally formed with the body, which simplifies manufacturing and ensures that the port housing is securely fixed so that it does not inadvertently become detached from the remainder of the body.

[0078] According to a preferred embodiment of the cap, the elastic sealing member of the first port is also formed by overmolding. This allows the same advantages as the overmolding of the valve member described above to be realized. If not formed by overmolding, the elastic sealing member is, for example, inserted into the first port housing and preferably fixed in place. For example, laser welding can be used to fix the elastic sealing member in place.

[0079] Where the resilient sealing member of the first port is also formed by overmolding, it is possible to form the valve member and the resilient sealing member as a single resilient member, i.e., as a single volume of resilient material formed by overmolding, which makes manufacture of the cap particularly simple as both the valve member and the resilient sealing member can be formed in one step.

[0080] To form the valve member and the resilient sealing member as a single resilient member, for example, a volume of resilient material can be formed by overmolding, with one portion of the volume acting as the valve member and another portion of the volume acting as the sealing member. The valve member and the sealing member can also be formed as a single volume connected by a sprue, which connects the portion forming the valve member and the portion forming the resilient sealing member together. Such a sprue allows the use of a single injection point, reducing the construction and operation costs of the mold.

[0081] Preferably, the outer diameter of the port housing is 20 mm or less, more preferably 15 mm or less, for good overmoldability and good usability of the first port.

[0082] Preferably, the elastic seal member or first port is partially covered by the distal portion of the port housing. This helps to control the deformation of the elastic seal member upon connection and disconnection of a piercing device, i.e., the forces required for connection and disconnection, as well as the ability of the elastic seal member to reseal. The distal surface portion of the elastic seal member that is not covered by the distal portion of the port housing is referred to as the "distal face" of the elastic seal member.

[0083] Preferably, the outer surface of the resilient seal member is substantially flush or completely flush with the edge surface of the port housing.

[0084] The outer surface of the elastic sealing member (septum) is the surface that faces outward when the cap is connected to the container body, i.e., the surface that does not face the inside of the container and does not contact the housing. The outer surface may also be referred to as the "distal surface" of the elastic sealing member. In particular for a container cap, the terms "distal" and "proximal" mean closer to or farther from the interior of the container body in the assembled state when the cap is connected to the container body.

[0085] The edge surface of the port housing is that portion of the surface of the port housing that defines the distal opening of the cavity in which a resilient sealing member, particularly formed by overmolding, is received. The edge surface thus defines the boundary of the opening. In a preferred embodiment, the port housing is formed as a hollow projection that projects from the remaining body of the cap. The resilient sealing member is received within the hollow projection. The edge surface of the port housing as viewed in the distal-proximal direction is the front surface of the projection.

[0086] The outer surface of the resilient seal member is perfectly flush with the edge surface of the port housing if the two surfaces meet continuously, whereby no step is formed in the area where the surface of the resilient seal member meets the surface of the port housing along the entire circumference of the resilient seal member. This means that the outer surface of the resilient seal member and the edge surface of the port housing are aligned. The outer surface of the resilient seal member is substantially flush with the edge surface of the port housing if a step of 1 mm or less, preferably 0.5 mm or less, more preferably 0.25 mm or less, most preferably 0.1 mm or less is formed. In other words, the outer surface of the resilient seal member is perfectly flush with the edge surface of the port housing if neither the outer surface of the resilient seal member nor the edge surface of the port housing protrudes or recedes relative to the other surface. The outer surface of the resilient seal member is substantially flush with the edge surface of the port housing if one of the surfaces in question protrudes or recedes relative to the other surface by a small offset (1 mm or less).

[0087] Such alignment of the outer surface of the resilient sealing member with the edge surface of the port housing makes the sterilization process of the resilient sealing member easier and safer, thus allowing the same advantages to be realized as in the flush alignment of the outer surface of the valve member with the edge surface of the valve housing.

[0088] With regard to disinfection efficiency, it is preferred that the outer surface of the elastic sealing member and the edge surface of the port housing are arranged in a completely flush manner. However, only a substantially flush arrangement with a small offset, e.g., 0.1 mm to 0.2 mm, may be sufficient or even preferred with regard to the robustness of the overmolding process. Such a small offset, if any, may be tolerated with regard to disinfection efficiency.

[0089] Having both ports on the same base (body) of the cap allows for efficient manufacturing of the fluid container since the container body only needs to be connected to one part. Furthermore, the body can be adapted to different container mouth shapes. This is especially true since the cap is efficiently manufactured according to the present invention.

[0090] The valve of the cap according to the invention provides a connection between the interior of a container body connected to the cap and a fluid handling device. In this case, the fluid handling device is a device capable of removing a fluid, such as a liquid, from the container or adding a fluid to the container. The fluid handling device may be, for example, a syringe without a needle attached. The valve opening is configured to be connected to a male connector part of the fluid handling device. This allows the movement of fluid between the interior of the container body connected to the cap and the fluid handling device. Preferably, the connection between the male connector part of the fluid handling device and the valve opening is fluid-tight. That is, fluid can flow exclusively through the valve via the male connector part of the fluid handling device.

[0091] Preferably, the valve opening is resealable, i.e. following removal of the fluid handling device, the valve opening closes automatically, whereby the valve member again seals the valve opening fluid-tight.

[0092] In a preferred embodiment of the cap according to the invention, the first port is an administration port, i.e. a port for withdrawing a liquid to be administered to a patient from the container body connected to the cap. For example, the elastic sealing member is adapted to be pierced by a spike of an administration device, such as an infusion set, a blood transfusion set, a transfer device, etc. By piercing the elastic sealing member by the spike, a fluid connection is established between the interior of the container body connected to the cap and the administration device.

[0093] Additionally or alternatively, in a further preferred embodiment of the cap, the second port is a needleless port, i.e. a port that can make a fluid connection with a syringe that is not equipped with a needle or similar device. In other words, the second port is not intended to be pierced by a needle or other device to make a fluid connection through the second port. It is preferred that the fluid connection between the inside of the container body connected to the cap and the syringe or other fluid handling device is a bidirectional fluid connection, i.e. fluid can flow either into or out of the container body through the valve opening.

[0094] Additionally or alternatively, in a further preferred embodiment, the outer (distal) surface of the elastic seal member is substantially flat or generally flat, where the outer surface is considered to be substantially flat if it has protrusions and / or recesses whose height is less than 10% of the maximum diameter of the outer surface, for example, the outer surface may have such recesses to indicate where a user should pierce the elastic seal member.

[0095] Preferably, the diameter of the resilient sealing member (measured transverse to the direction in which it is pierced) is large enough so that the resilient material in the space between the port housing and a piercing device, such as a spike, that is pierced through the resilient sealing member does not have to be squeezed upon insertion of the piercing device, thereby preventing high friction against the piercing device being inserted and facilitating insertion of the piercing device.

[0096] Preferably, the diameter of the resilient sealing member (measured transverse to the direction in which it is pierced) is small enough to ensure sufficient force to retain the piercing device.

[0097] Additionally or alternatively, in a further preferred embodiment the diameter of the valve member, measured transverse to the direction in which the valve member is pierced, is at least 8mm, preferably at least 9mm, and / or no more than 13mm, preferably no more than 11mm.

[0098] The resilient sealing member may have a non-circular shape, for example the resilient sealing member may be elliptical, in which case the preferred diameters mentioned above are to be understood as the smaller dimension of the non-circular shape, e.g. the minor axis of the ellipse.

[0099] Preferably, the thickness of the elastic sealing member (measured in the direction in which it is pierced) is selected to ensure sufficient resealability and sufficient force to retain the piercing device, while avoiding excessive force for insertion of the piercing device.

[0100] Additionally or alternatively, in a further preferred embodiment, the thickness of the elastic sealing member, measured in the direction in which the elastic sealing member is pierced, is 1.5 mm or more, preferably 2 mm or more, and / or 5 mm or less, preferably 4 mm or less.

[0101] Preferably, the material of the resilient sealing member is selected to ensure sufficient resealability and force to retain the piercing device, while avoiding excessive force for insertion of the piercing device.

[0102] Preferably, the valve member has a T-shaped cross section. Such a valve member does not fill the entire cavity in the valve housing. Instead, only a distal valve portion extends across the cross section in the valve housing and thus closes the valve housing at this distal side, so that fluid can only pass through the valve opening (provided that the valve is in an open operating state). That is to say, the distal portion, for example having a disk-like shape, fills the inner diameter of the housing and is bonded circumferentially and seamlessly to the valve housing. In this way, leakage around the valve member is prevented and the resistance to shearing during connection is improved. A proximal portion of the valve member is connected to the distal portion. Here, the proximal portion can have the form of a ridge extending in the diameter direction of the valve housing. In a cross section in a plane perpendicular to the ridge, the T-shape of the valve member is visible. Among other things, such a T-shape allows to provide a long slit with good resealability and at the same time to save material.

[0103] Additionally or alternatively, in a further preferred embodiment, the elastic sealing member comprises at least one thermoplastic elastomer, more preferably at least one thermoplastic elastomer selected from the group consisting of styrenic block copolymers, thermoplastic polyolefin elastomers, thermoplastic vulcanizates, thermoplastic polyurethanes, thermoplastic copolyesters, and thermoplastic polyamides.

[0104] Additionally or alternatively, in a further preferred embodiment, the resilient sealing member comprises a resilient material having a hardness between 25 and 55 Shore A.

[0105] Additionally or alternatively, the resilient seal member includes a resilient material that includes a pigment and / or dye capable of absorbing electromagnetic radiation. The presence of a material capable of absorbing electromagnetic radiation may, for example, enhance the ease of laser welding to connect the resilient seal member to the port housing. However, it is preferred that the resilient seal member is also formed by overmolding, so as to avoid the need for a separate step to connect the resilient seal member to the port housing.

[0106] Additionally or alternatively, in further preferred embodiments, the diameter of the valve member (measured transversely to the direction in which the fluid handling device is connected to the second port) is 13 mm or less, preferably 11 mm or less, and / or 8 mm or more, preferably 9 mm or more. In embodiments of the invention in which the valve housing comprises an externally threaded configuration, the diameter of the valve housing, and therefore the diameter of the valve member, is limited by the diameter of the corresponding internal thread of the fluid handling device to which it is intended to be connected.

[0107] The valve member may have a non-circular shape, for example the valve member may be elliptical, in which case the preferred diameters mentioned above are to be understood as the smaller dimension of the non-circular shape, for example the minor axis of the ellipse.

[0108] Additionally or alternatively, in a further preferred embodiment, the length of the valve member (measured in the direction in which the fluid handling device is connected to the second port) is between 3 mm and 12 mm, preferably between 5 mm and 10 mm. Here, the length may be selected to be at least the minimum length that ensures a tight seal after disconnection of the fluid handling device. The maximum length depends on the length of the male connector. For luer-shaped and similar designs of the male connector, a length between 3 mm and 12 mm will usually be appropriate. For connectors of other designs, different lengths may be more appropriate.

[0109] Additionally or alternatively, in a further preferred embodiment, the body comprises a polyolefin, preferably at least one of polypropylene and polyethylene, and / or an engineering plastic, preferably at least one of polyamide, polycarbonate and polystyrene.

[0110] Additionally or alternatively, in a further preferred embodiment, said body comprises a polymeric material having a tensile and / or flexural modulus of at least 700 MPa.

[0111] Additionally or alternatively, in a further preferred embodiment, the valve member provides a fluid-tight connection with the fluid handling device, and in particular a releasable connection such that the fluid handling device can be fluid-tightly connected and disconnected multiple times.

[0112] The valve housing of the second port may include a threaded structure, preferably a threaded structure adapted for connection with a male Luer lock structure.

[0113] Preferably, the portion of the valve housing that mates with the threaded structure has a length (measured axially, i.e., in a distal-proximal direction) of at least 3.5 mm, whereby the threaded structure is long enough to ensure a secure connection of the locking structure, and short enough for a convenient number of turns to close the locking connection, for ease of use. The length of the threaded portion may be selected depending on the design of the fluid handling device to which it is intended to be connected. For luer lock configurations of male connectors and similar designs, lengths between 3.5 mm and 5.5 mm are usually appropriate. For connectors of other designs, different lengths may be more appropriate.

[0114] Preferably, the distal portion of the valve housing, ie the portion which may include threads, has a diameter of 18mm or less, more preferably 13.5mm or less.

[0115] Preferably, the height of the cap is between 12 mm and 50 mm, more preferably between 14 mm and 30 mm, measured transversely to the mouth of the container body 200 to which the cap 1 is connected. Such a height may be seen as a compromise between user-friendly handling, low residual volume in the cap 1 and space requirements during transportation and storage.

[0116] Preferably, the proximal-distal direction of the first port and the proximal-distal direction of the second port are not parallel to each other but enclose an acute angle, more preferably an angle between 15 degrees and 45 degrees, even more preferably an angle between 25 degrees and 35 degrees. In other words, the first port and the second port are preferably arranged at an angle. The angled arrangement of the first port and the second port allows or at least facilitates a piercing device and a fluid handling device to be simultaneously connected to the first port and the second port, respectively. Forming the valve member and optionally the elastic sealing member by overmolding techniques is advantageous when an angled arrangement of the ports is intended, since it is particularly cumbersome to insert prefabricated elastic members in different directions.

[0117] When a container with a cap according to the invention is used to administer a liquid to a patient, the container and the cap are typically oriented with the cap at the bottom, such that the proximal-distal direction of the first port is vertical, while the proximal-distal direction of the second port is inclined. The latter inclined orientation may make it easier for a user to administer a substance through the second port, for example using a syringe.

[0118] Optionally, a peel foil is placed on top of the resilient sealing member and / or on top of the valve member of the cap, particularly by welding the peel foil to the port housing or the valve housing, respectively, such peel foil covering the distal ends of the resilient sealing member and the valve member, respectively.

[0119] The peel foil is removed before the piercing device is pierced through the elastic sealing member and before the male connector is inserted into the valve opening, respectively. The peel foil seals and protects the respective ports and is particularly tamper-evident, since it allows one to easily determine whether the respective elastic member is damaged or has already been connected to a piercing device or a male connector, respectively. Furthermore, the peel foil provides additional sealing to the respective ports and also helps to ensure the mechanical integrity of the port, for example when the cap is subjected to mechanical stress. Compared to break-away parts, the peel foil is less susceptible to damage. This is due to its flat structure. Furthermore, less material is required for the peel foil. Furthermore, the use of a peel foil leads to shorter containers, which is advantageous for storage and transportation.

[0120] The fluid container according to the invention is a fluid container, in particular for medical fluids, comprising: - a hollow container body having a container body opening; a cap according to the invention; Equipped with.

[0121] The body of the cap is in liquid-tight connection with the opening.

[0122] The fluid container may include a cap according to any one of the embodiments of the present invention.

[0123] A further method according to the invention is a method for manufacturing a cap for a fluid container, in particular for a container for medical fluids. The cap to be manufactured comprises a body. The cap further comprises a first fluid port having a port housing and a resilient sealing member. The cap further comprises a second fluid port having a valve comprising a valve housing and a resilient valve member. The method comprises the steps of: A) manufacturing or providing the body, the port housing, and the valve housing, preferably the body having at least one of the port housing and the valve housing integrally formed therewith; B) overmolding the resilient seal member into the port housing; C) overmolding the valve member into the valve housing; D) optionally placing a release foil on top of the seal member and / or on top of the valve member; Includes.

[0124] Preferably, steps B and C are performed at least partially simultaneously, which may for example improve time efficiency, or step C may be performed before step B or vice versa.

[0125] More preferably, said seal member and said valve member are formed as a single volume, optionally joined by at least one sprue.

[0126] In a preferred embodiment, the above further method includes the additional step of cutting a slit in said valve member, preferably with a lubricated blade. [Brief description of the drawings]

[0127] Other features and advantages of the present invention can be found in the description of exemplary embodiments with the aid of the attached drawings. [Figure 1]FIG. 1 is a schematic side view of a valve according to a first embodiment of the present invention. [Diagram 2] FIG. 2 is a schematic side view of a valve according to a first embodiment of the present invention, in a view rotated by 90° relative to the view of FIG. 1; [Diagram 3] Figure 3(a) is a schematic top view of a valve according to a first embodiment of the present invention, and Figure 3(b) is a schematic bottom view of the valve according to the first embodiment of the present invention. [Figure 4] Figure 4(a) is a perspective view of the valve according to the first embodiment of the present invention, as viewed obliquely from above. Figure 4(b) is a perspective view of the valve according to the first embodiment of the present invention, as viewed obliquely from below. Figure 4(c) is a further perspective view of the valve according to the first embodiment of the present invention, as viewed obliquely from below. [Diagram 5] 2 is a schematic cross-sectional view of the valve according to the first embodiment taken along the plane AA shown in FIG. 1. [Figure 6] 3 is a schematic cross-sectional view of the valve according to the first embodiment taken along plane CC shown in FIG. 2. [Figure 7] FIG. 4 is a schematic side view of a valve according to a second embodiment of the present invention. [Figure 8] FIG. 8 is a schematic side view of a valve according to a second embodiment of the invention, in a view rotated by 90° relative to the view of FIG. 7; [Figure 9] Figure 9(a) is a schematic top view of a valve according to a second embodiment of the present invention, and Figure 9(b) is a schematic bottom view of the valve according to the second embodiment of the present invention. [Figure 10] Figure 10(a) is a perspective view of a valve according to a second embodiment of the present invention, as viewed obliquely from above. Figure 10(b) is a perspective view of a valve according to a second embodiment of the present invention, as viewed obliquely from below. Figure 10(c) is a further perspective view of a valve according to the second embodiment of the present invention, as viewed obliquely from below. [Figure 11] 8 is a schematic cross-sectional view of the valve according to the second embodiment taken along the plane AA shown in FIG. 7. [Figure 12] 9 is a schematic cross-sectional view of the valve according to the second embodiment taken along plane CC shown in FIG. 8. [Figure 13] 4 is a schematic cross-sectional view of a cap according to a further embodiment of the present invention. [Figure 14] 14 is a schematic perspective view showing an upper portion of the cap according to the embodiment shown in FIG. 13 cut into two parts along a cutting plane, from an oblique downward angle. FIG. [Figure 15] 15 is a schematic cross-sectional view of a fluid container according to a further embodiment of the present invention, the container comprising a cap according to the embodiment shown in Figures 13 and 14; [Figure 16] Figure 16(a) is a schematic perspective and partially translucent view of a second port of a cap according to a further embodiment, and Figures 16(b) and 16(c) are perspective views showing a second sealing member of the cap. [Figure 17] Figure 17(a) is a schematic perspective and partially translucent view of a second port of a cap according to a further embodiment, while Figures 17(b) and 17(c) are perspective views showing the second sealing member of that cap provided with an additional rib (523) to further improve reseal behaviour. [Figure 18] Figure 18(a) is a schematic perspective and partially translucent view of a second port of a cap according to a further embodiment, while Figures 18(b) and 18(c) are perspective views showing the second sealing member of that cap provided with an additional rib (523) to further improve reseal behaviour. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0128] Figures 1 to 6 show different views of a valve 5 according to a first embodiment of the present invention. In connection with the description with reference to these figures, the terms "top", "bottom", "above" and "below" refer, without loss of generality, to the orientations shown in Figures 1, 2, 5 and 6. The upper side is also referred to as the "distal side" and the lower side as the "proximal side".

[0129] The valve 5 comprises a valve housing 51. Preferably, said housing comprises a plastic material, such as a polyolefin and / or an engineering plastic, in particular polyethylene and / or polypropylene are used as polyolefins.

[0130] In the embodiment shown in Figures 1-6, the valve housing 51 has a substantially cylindrical lower portion and an upper portion having a substantially cylindrical inner wall. The upper portion has a smaller diameter than the lower portion. The lower portion and the upper portion are connected by a tapered intermediate portion, whereby the valve housing 51 has a closed sidewall but is open at the top and bottom. This shape is exemplary only. In further embodiments not shown, the valve housing may have, for example, a non-circular diameter. Regardless of the specific shape of the valve housing, it is preferred that the valve housing 51 has a closed sidewall and is at least partially open at the top and bottom sides, whereby the valve housing 51 defines a passage between the open sides.

[0131] The bottom of the valve housing 51 may be connected to any device such as an apparatus or vessel to allow fluid to enter or leave the device through the valve 5 .

[0132] The valve 5 further comprises a valve member 52. The valve member 52 comprises a valve opening 522. In Figures 1 to 6 the valve 5 is shown in a closed operational state. In this state the valve opening 522 is closed such that the valve member 52 blocks the valve, i.e. prevents fluid from flowing through the passageway defined by the valve housing 51.

[0133] In a further operational state ("open operational state") not shown, the valve opening 522 is open to allow fluid to flow through a passage defined by the valve housing 51. Here, the cross-sectional area of ​​the open valve opening 522 may be smaller than the cross-sectional area of ​​the passage.

[0134] In a first embodiment, the valve member 52 does not fill a cavity in the valve housing 51. Instead, only the distal valve portion 52a extends over a cross-sectional area in the valve housing 51 and therefore closes the valve housing 51 on this side so that fluid can only pass through the valve opening 522 (provided that the valve 5 is in an open operating state). That is to say, the distal portion 52a, shown as a disk-shaped portion in FIG. 6, fills the housing inner diameter and is connected to said valve housing in a circumferentially uninterrupted manner. This prevents leakage around the valve member and improves the resistance to shearing of the connection. The proximal portion 52b of the valve member 52 is connected to the distal portion 52a, the proximal portion 52b being in the form of a ridge extending in the diametric direction of the valve housing 51. In cross section in a plane perpendicular to said ridge, the valve member 52 has a T-shape. Such a T-shape makes it possible in particular to provide long slits with good resealability and at the same time to save material.

[0135] In further embodiments not shown, the valve member 52 has a different shape. The valve member 52 may, for example, fill the entire cavity in the valve housing 51.

[0136] The valve member 52 includes a valve opening 522. In the first embodiment, the valve opening 522 is a slit formed in the valve member. The slit has a width w (Figure 5). The slit extends over the entire axial length of the valve member (top to bottom in Figures 1, 2, 5 and 6). The distal and proximal ends of the slit are visible in Figures 3(a) to 4(c). The slit lies in plane AA shown in the cross-section of Figure 5. The slit is therefore perpendicular to plane CC shown in the cross-section of Figure 6.

[0137] Preferably, the valve opening 522 is adapted to receive a male connector of a fluid handling device, such as the cone of a syringe, such that said male connector can be inserted into the valve opening in an axial, i.e., distal to proximal, direction ("distal-proximal direction").

[0138] By inserting a suitable male connector, the valve 5 is switched from a closed to an open operating state, i.e. the male member spreads the walls of the slit, which are in contact with each other in the closed operating state.

[0139] The valve member 52 is formed by overmolding, i.e. the material of the valve member 52 is injected into the valve housing 51 using a molding technique.

[0140] According to a first embodiment, the distal face 521 of the valve member 52 projects further than the distal end of the valve housing 51, i.e. beyond the edge face 512 of said valve housing. In this way, the upper part of the distal portion 52a forms a projecting cap atop the open distal side of the valve housing 51. As can be seen in particular in Figures 5 and 6, the cover may overlap the distal edge face 512 of the valve housing 51, for example to additionally anchor the valve member 52 in the valve housing 51 and hold it in place. However, such an overlap of the distal edge face is optional.

[0141] As shown in Figures 1 to 6, the valve housing is provided with a male threaded structure 53. The threaded structure 53 is adapted to engage with a corresponding threaded structure disposed on a male connector. The threaded structure 53 and the corresponding threaded structure provide a means for locking the connection between the valve and the male connector. The design of the threaded structure 53 depends on the design of the corresponding threaded structure of a fluid handling device or other device that is intended to be connected to the valve 5. Preferably, the threaded structure 53 is designed according to one of the subparts of the ISO 80369 series of standards, since connection structures according to these standards are frequently used in the medical field.

[0142] According to a further embodiment of the invention not shown, a different structure for locking the connection with a male connector having a corresponding locking structure, for example a means for a snap connection, is provided. According to a further embodiment of the invention not shown, no structure for locking the connection is provided at all, so that the male connector is held in place only by the force exerted by the valve member, which may be sufficient for many applications.

[0143] The valve member 52 includes a valve opening 522, which is preferably configured to provide a fluid-tight connection with a corresponding male connector of a fluid-handling device, such as a syringe without a needle attached. The valve opening 522 in the embodiment shown in Figures 1 to 6 is formed by a single slit 522 in the cut surface along the axial direction. In an alternative embodiment not shown, multiple slits may be provided whose cut surfaces intersect each other along the axis. In a cross section perpendicular to the axial direction, the cuts form a cross or a star. Furthermore, valve openings of, for example, H-shaped cross sections or other shapes are also possible.

[0144] The configuration and size of the valve opening depends on how the connection of the device to which it is intended to be connected, i.e. the male connector, is formed. If connection with a conventional syringe is to be permitted, the valve opening may be formed, for example, as a slit 522, as described above.

[0145] Preferably, the valve opening 522 is resealable, i.e., after the fluid-handling device is removed, the valve opening 522 closes, thereby ensuring that the resilient valve member 52 again fluid-tightly closes the valve 5. More preferably, this resealability is maintained even if the fluid-handling device is again connected and disconnected several or many times.

[0146] In specific examples of the above-described embodiments and possible variations thereof, the valve member 52 comprises at least one thermoplastic polymer, preferably at least one polymer selected from the group consisting of styrenic block copolymers, thermoplastic polyolefin elastomers, thermoplastic vulcanizates, thermoplastic polyurethanes, thermoplastic copolyesters, and thermoplastic polyamides.

[0147] Additionally or alternatively, the valve member 52 comprises a resilient material having a hardness between 35 Shore A and 45 Shore A.

[0148] Figures 7 to 12 show different views of a valve 5 according to a second embodiment of the present invention. In connection with the description with reference to these figures, the terms "top", "bottom", "above" and "below" refer, without loss of generality, to the orientations shown in Figures 7, 8, 11 and 12. Furthermore, the upper side is the "distal side" and the lower side is the "proximal side".

[0149] Most of the features of the valve 5 according to the second embodiment are identical to those of the valve 5 according to the first embodiment, so reference is made to the description of the first embodiment above. The same reference numerals are therefore used for both embodiments. Furthermore, the modifications described for the first embodiment, for example with regard to the screw arrangement 53 or its possible absence, are also possible for the second embodiment.

[0150] The second embodiment differs from the first embodiment in that the distal surface 521 of the valve member 52 does not protrude beyond the distal end of the valve housing 51, such that the distal surface 521 is completely flush or substantially flush with the distal edge surface 512 of the valve housing 51.

[0151] The distal surface 521 of the valve member 52 and the edge surface 512 of the valve housing 51 are perfectly flush when these two surfaces meet continuously with each other. Thereby, no step is formed along the entire circumference of the valve member 52 in the area where the surfaces of the valve member 52 and the valve housing 51 meet each other. This means that the outer surface of the valve member 52 is aligned with the edge surface 512 of the valve housing 51. The distal surface 521 of the valve member 52 and the edge surface 512 of the valve housing 51 are substantially flush if a step is formed between these surfaces of 1 mm or less, preferably 0.5 mm or less, more preferably 0.25 mm or less, most preferably 0.1 mm or less. In other words, the distal surface 521 of the valve member 52 is perfectly flush with the edge surface 512 of the valve housing 51 if neither surface protrudes or recedes with respect to the other. The distal surface 521 of the valve member 52 is substantially flush with the edge surface of the valve housing 51, with one of the surfaces in question projecting or recessed by a small offset (1 mm or less) relative to the other surface.

[0152] Due to this alignment of the distal surface 521 of the valve member 52 with the edge surface 512 of the valve housing 51, the sterilization process of the valve member 52 is made easier and safer.

[0153] In the specific embodiment shown in Figures 7 to 12, the distal surface 521 of the valve member 52 and the edge surface 512 of the valve housing 51 are substantially flush with each other, with only a slight step of less than 0.5 mm.

[0154] Figures 13 and 14 are schematic diagrams of a cap according to a further embodiment of the invention. The cap 1 is intended to be attached to an opening 201 of a container body 200. The cap 1 and the container body 200 to which the cap is attached as a container closure together form a container 100 according to the invention. A container 100 including a cap 1 according to the embodiment shown in Figures 13 and 14 is shown in Figure 15. The container 100 shown in Figure 15 contains a liquid 300 that is not part of the container 100. The opening 201 of the container body 200 is formed as a neck of the container, the axial part of which is surrounded by the connecting part 3 of the cap 1. Other configurations of the opening and the connecting part of the container body are also possible. For example, there may be a neck entirely surrounded by the connecting part 3, or a neckless opening may be attached by glue, welding, etc. to the front surface of the cap 1 that serves as the connecting part 3.

[0155] Preferably, the fluid 300 is a medical fluid, such as a liquid medicament, In other words, the container 100 is preferably suitable for containing a medical fluid and for use in a medical environment.

[0156] Preferably, the container 100 is hermetically closed when both ports are in a closed state, i.e. when neither the administration device nor the fluid handling device is connected to the respective port. During use, e.g. during intravenous administration of fluid, the container 100 is usually placed in an upside down orientation, i.e. with the cap 1 in the lowest position, so that said liquid 300 can flow from the container body 200 into the administration device connected to the first port 4. When adding fluid to the interior of the container 100 through the second port 5 using a fluid handling device, generally no particular orientation of the container 100 is required.

[0157] The cap 1 includes a body 2 that constitutes the main portion of the cap 1. In the illustrated embodiment, the body 2 is a hollow, bowl-shaped structure, - an opening in the bottom connection part 3 in the orientation shown, and - A protrusion located on the elevated section on the upper side of the main body where ports 4 and 5 (described later) are formed. . . . are shown as having

[0158] The lands and protrusions are optional.

[0159] In the illustrated embodiment, the lower portion of the cap 1 is circular because the cap 1 according to this embodiment is intended to be attached to a container body 200 having a circular opening 201. The shape of the lower portion of the cap 1 may be other shapes of opening, such as an oval or a rectangle with rounded corners.

[0160] In the illustrated embodiment, the connection portion 3 is shown to be a tapered annular portion of the inner surface of the cap 1. In other embodiments, the connection portion may include, for example, a cylindrical inner surface portion, an inner surface portion having a step, a front surface at the lower edge of the cap 1, etc. Also, when connecting the cap 1 to the container body 200, the connection portion 3 may be deformed, especially when welding or other processes involving heat are used.

[0161] The cap comprises two ports 4, 5. The first port 4 can serve, for example, as an administration port. The second port 5 can serve, for example, as a medication port.

[0162] When the cap 1 is connected to the container body 200 , both ports 4 , 5 provide access points for the introduction and removal of fluids from the container 100 .

[0163] The piercing device and the fluid handling device are not part of the container according to the present invention.

[0164] The second port 5 includes or is constituted by a valve 5 according to the invention.

[0165] 13 is a cross-sectional view, the plane of which coincides with the plane in which the valve opening 522, formed as a slit, lies, which is therefore depicted as a hatched rectangular area in the valve member 52.

[0166] Preferably, the valve housing 51 is integrally formed with the body 2 of the cap 1, since then both the body 2 and the valve housing 51 can be formed in a single manufacturing step, for example by using injection molding techniques. Alternatively, the valve housing 51 is not integrally formed, but instead at least a part of said valve housing is formed as an element that is attached to the remaining body of the cap, for example by laser welding. Regarding the preferred features of the valve 5 being part of the cap 1, reference is made to the above explanations regarding the preferred features and embodiments of said valve.

[0167] The first port 4 is provided with an elastic seal member 42. This elastic seal member 42 is received in the port housing 41 and sealably closes the port housing 41.

[0168] 13 and 14, the port housing 41 is a hollow cylindrical projection formed integrally with the body 2. An upper edge or circular front face 412 of the port housing 41 defines an opening 411.

[0169] In a further embodiment, the cylindrical protrusion has a non-circular cross-section, for example an elliptical cross-section. In a further embodiment, the protrusion is conical.

[0170] In a further embodiment, the port housing is not integrally formed with the body, but instead at least a portion of the port housing is formed as an element that is attached to the remaining body of the cap, for example by laser welding.

[0171] The port housing 41 contains an elastic seal member 42. According to this embodiment, the elastic seal member 42 is formed as a pierceable septum 42 that can be pierced by a spike of an infusion set or other piercing device. That is, if the septum 42 is not pierced by a piercing device, the septum 42 closes the opening of the first port 4. If a hollow piercing device pierces the septum 42, fluid can flow through said piercing device. In other words, if the cap 1 is connected to the container body 200, the piercing device that pierces the septum 42 serves as a fluid inlet or fluid outlet of the container 100.

[0172] Preferably, septum 42 is self-sealing, i.e., the channel formed in the material of septum 42 by the piercing device automatically closes after the piercing device is withdrawn from septum 42.

[0173] Preferably, the size of septum 42 is large enough, measured transverse to the direction in which septum 42 is pierced, that the resilient material in the space between a piercing device, such as a spike, pierced through septum 42 and port housing 41 does not have to be significantly compressed during insertion of the piercing device, thereby facilitating insertion of the piercing device without creating significant friction against the piercing device being inserted. More preferably, the size of septum 42 is small enough, measured transverse to the direction in which septum 42 is pierced, that there is sufficient force to retain the piercing device.

[0174] Additionally or alternatively, in a further preferred embodiment, the septum has a diameter measured transverse to the direction in which the septum is pierced that is at least 8 mm, preferably at least 9 mm, and / or no greater than 13 mm, preferably no greater than 11 mm.

[0175] Preferably, the thickness of septum 42 (measured in the direction in which septum 42 is pierced) is selected to ensure sufficient resealability and sufficient force to retain the piercing device, while avoiding excessive force for insertion of the piercing device. Additionally or alternatively, in further preferred embodiments, the thickness of septum 42 (measured in the direction in which septum 42 is pierced) is 1.5 mm or more, preferably 2 mm or more, and / or 5 mm or less, preferably 4 mm or less. Preferably, the proximal surface of septum 42 is flat or has a rounded cavity or pattern.

[0176] Preferably, the partition 42, in particular together with the valve member 52, is formed by overmolding either as one overmolded volume, i.e. by injecting the materials of the elements 42 and 52 through a single injection point, or as two separate volumes, i.e. by injecting the materials of the elements 42 and 52 through at least two injection points. Such two separate volumes may optionally be connected by a sprue 6.

[0177] Alternatively, the septum 42 may be inserted into the port housing 41 as a separate piece and secured in place using, for example, a welding technique, particularly laser welding, rather than being formed in situ by overmolding. In particular, if the septum 42 is formed as a separate piece, the septum 42 may include a material that includes a pigment and / or dye capable of absorbing electromagnetic radiation to facilitate ease of laser welding to connect the septum 42 to the port housing 41.

[0178] In a specific embodiment, the elastic sealing member 42 comprises at least one thermoplastic elastomer, more preferably at least one thermoplastic elastomer selected from the group consisting of styrenic block copolymers, thermoplastic polyolefin elastomers, thermoplastic vulcanizates, thermoplastic polyurethanes, thermoplastic copolyesters, and thermoplastic polyamides. The septum 42 is most preferably formed in situ by overmolding.

[0179] Additionally or alternatively, in a more preferred embodiment, the resilient seal member 42 comprises a resilient material having a hardness between 25 Shore A and 55 Shore A.

[0180] 13 and 14, the outer surface 421 (distal surface) of the elastic sealing member 42 is substantially flat with only small protrusions and / or recesses. Optionally, the elastic sealing member 42 may have a small recess, for example in a central portion of said surface 421, to indicate where a user should pierce said elastic sealing member.

[0181] In the embodiment shown in Figures 13 and 14, the opening of the port housing 41 is defined by the front surface of the port housing 41. That is, the front surface is the edge surface 412 of the port housing 41. In the embodiment shown in Figures 13 and 14, the edge surface 412 has a circular toroidal shape. In alternative embodiments, the edge surface may have a different shape, for example an elliptical toroidal shape. In the embodiment shown in Figures 13 and 14, the edge surface is flat and perpendicular to the distal-proximal direction, i.e., the direction in which the piercing device should pierce the septum 42. In alternative embodiments, the edge surface 412 can have a different shape and / or a different orientation. For example, it may be rounded and / or tapered (i.e., angled relative to the distal-proximal direction).

[0182] In the embodiment shown in FIGS. 13 and 14, the outer surface 421 (distal surface) of the septum 42 is flush with the edge surface 412 .

[0183] That is, the edge surface 412 and the distal surface 421 of septum 42 meet continuously such that no step is formed along the circumference of septum 42 in the area where the resilient sealing member and the port housing meet one another.

[0184] In an alternative embodiment, the septum 42 is not completely flush with the edge surface 412, but only substantially flush with it. This means that there is no more than a step between the distal surface 421 of the septum 42 and the edge surface 412 of 1 mm or less, preferably 0.5 mm or less, more preferably 0.25 mm or less, and most preferably 0.1 mm or less.

[0185] A peel-off foil 44 may be disposed on top of the elastic seal member 42. The peel-off foil 44 may be a foil including a plastic and / or metal material, such as an aluminum-plastic composite foil. The peel-off foil 44 may be connected to the cap 1 by welding to the edge surface 412 of the port housing 41.

[0186] The term "peel-off foil" preferably indicates that the foil can be peeled off manually by a user without the aid of a tool.

[0187] The peel foil 44 is removed before the piercing device penetrates the resilient sealing member 41. The peel foil 44 seals and protects the resilient sealing member 42 and, in particular, provides tamper evidence, since it makes it easier to determine if the resilient sealing member 42 is damaged or has already been pierced. Furthermore, the peel foil 44 provides an additional seal to the first port 4 and helps ensure the mechanical integrity of the first port 4, for example, when the cap 1 is subjected to mechanical stress.

[0188] The second port 5 may have a comparable release foil 54 .

[0189] Preferably, the body 2 includes a polyolefin, more preferably consists of a polyolefin. In particular, the polyolefin of the body 2 is a material selected from the group consisting of polyethylene, polypropylene and ethylene-propylene copolymer, or a mixture of a plurality of materials selected from these.

[0190] 13 and 14, the proximal-distal direction for the first port 4 and the proximal-distal direction for the second port 5 are not parallel to each other but enclose an acute angle. In other words, the first port 4 and the second port 5 are disposed at an angle.

[0191] The angular arrangement of the first port 4 and the second port 5 makes it possible, or at least makes it easier, for a piercing device and a fluid handling device to be simultaneously connected to the first port 4 and the second port 5, respectively.

[0192] When a container 100 with a cap 1 according to the invention is used to administer a liquid 300 to a patient, the container 100 and cap 1 are typically oriented upside down compared to the orientation shown in Fig. 15. Thus, the proximal-distal direction of the first port 4 is vertical, whereas the proximal-distal direction of the second port 5 is inclined. The latter inclined orientation may make it easier for a user to administer a substance through the second port 5, for example using a syringe.

[0193] 16(a) shows a perspective view of a further embodiment of valve 5. Valve housing 51 is shown in a semi-transparent manner so that portions of elastomeric valve member 52 within valve housing 51 are visible. The distal end of elastomeric valve member 52, with the distal end of slit 522, faces to the right.

[0194] In FIG. 16(b), only the elastic valve member 52 is shown from the same perspective.

[0195] In FIG. 16(c), the elastomeric valve member 52 is shown in another perspective such that the proximal end of the slit 522 is visible.

[0196] A distal portion of the resilient valve member is configured to fit into an opening in the valve housing 51. In Figures 16(a)-16(c), the distal portion is shown as a disc by way of example.

[0197] The proximal portion of the elastomeric valve member 52 is formed by protrusions that surround the slit 522 and mate with the lateral sides of the valve housing 51 but do not completely fill the second port housing 51 transverse to the slit 522. Because of the resulting cavity, the elastomeric valve member 52 is sufficiently flexible to allow easy insertion of a male connector.

[0198] Figures 17(a) to 17(c) show perspective views of a further embodiment of a valve 5 and a resilient valve member 52. These views correspond to the views of Figures 16(a) to 16(c).

[0199] The valve 5 and the elastic valve member 52 of the embodiment according to Figures 17(a)-17(c) correspond to the valve 5 and the elastic valve member 52 of the embodiment according to Figures 16(a)-16(c), respectively, except that the proximal part of the elastic valve member 52 of the embodiment according to Figures 17(a)-17(c) is provided with a straight rib 523 perpendicular to the protrusion surrounding the slit 522. Said rib(s) is fitted into the valve housing 51 and provides an additional elastic force to keep the opening tightly closed when no male connector is present and to press the inner wall of said opening tightly against said male connector when said male connector is inserted into said opening.

[0200] The valve 5 and elastic valve member 52 of the embodiment according to Figures 18(a) to 18(c) correspond to the valve 5 and elastic valve member 52 of the embodiment according to Figures 17(a) to 17(c), respectively, except that the rib(s) are curved rather than straight.

Claims

1. A valve (5), a valve housing (51), a resilient valve member (52) accommodated within said valve housing (51) and configured to close said valve (5) when said valve (5) is in a closed operating condition; Equipped with The valve member (52) includes a valve opening (522); the valve opening (522) is configured to be closed when the valve (5) is in a closed operational state and to provide a fluid passageway through the valve (5) when the valve (5) is in an open operational state; The valve member (52) is overmolded into the valve housing (51). A valve characterized by:

2. A valve (5) according to claim 1, the connection between the valve member (52) and the valve housing (51) is liquid-tight; At least a portion of the valve member (52) is coupled to the valve housing (51) along the entire circumference of the valve housing (51). A valve characterized by:

3. A valve (5) according to any one of claims 1 to 2, The valve member (52) comprises at least one thermoplastic elastomer selected from the group consisting of styrenic block copolymers, thermoplastic polyolefin elastomers, thermoplastic vulcanizates, thermoplastic polyurethanes, thermoplastic copolyesters, and thermoplastic polyamides; The material of the valve member (52) has a hardness between 25 Shore A and 55 Shore A, or between 35 Shore A and 45 Shore A. A valve characterized by:

4. A valve (5) according to claim 1 or 2, the valve housing (51) is made of a material having a tensile and / or flexural modulus of at least 700 MPa; and / or the material of the valve housing (51) comprises a polyolefin; and / or The material of the valve housing (51) includes engineering plastics. A valve characterized by:

5. A valve (5) according to claim 1 or 2, the valve member (52) being configured to provide a fluid-tight connection with a fluid-handling device; the valve opening (522) being a self-sealing valve opening (522); A self-sealing slit (522) is formed in the valve member (52) as a self-sealing channel (522) for a male connector; the valve member (52) is preloaded by elastic deformation and / or comprises an elastic structure (523), the elastic deformation and / or the elastic structure (523) providing a spring force that closes the channel (522) after a male connector inserted in the channel (522) is withdrawn from the channel (522); and / or A lubricant is provided in the valve opening (522). A valve characterized by:

6. A valve (5) according to claim 1 or 2, The valve member (52) is configured to tightly connect with a male connector, The male connector is designed in accordance with any subpart of the ISO 80369 series of standards, and / or The valve housing (51) includes a thread structure (53) according to one of the subparts of the ISO 80369 series of standards. A valve characterized by:

7. A valve (5) according to claim 1 or 2, the outer surface (521) of the valve member (52) is substantially flush or completely flush with the edge surface (512) of the valve housing (51), or The outer surface (521) of the valve member (52) protrudes beyond the edge surface (512) of the valve housing (51). A valve characterized by:

8. A method for manufacturing a valve (5) according to claim 1 or 2, comprising the steps of: The above method is A) manufacturing or providing a valve housing (51); B) overmolding a resilient valve member (52) into said valve housing (51); D) placing a release foil (54) on top of said valve member (52); Including, In step A, the valve housing (51) is manufactured by molding. A method comprising:

9. A cap (1) for a fluid container (100) for a medical fluid (300), comprising: (i) a body (2) including a container connection portion (3) adapted to be tightly connected to a container opening (201) of a container body (200); (ii) a first port (4) including a port housing (41); The first port (4) further includes a resilient sealing member (42); The seal member (42) is housed within the port housing (41) and tightly closes the port housing (41); The sealing member (42) is formed as a pierceable septum (42); (iii) a second port (5) including a valve according to claim 1 or 2; A cap characterized by:

10. A cap (1) according to claim 9, The seal member (42) is overmolded into the port housing (41); the seal member (42) and the valve member (52) form a single resilient member that is overmolded onto the body (2); The seal member (42) and the valve member (52) are connected via a sprue (6). A cap characterized by:

11. A cap (1) according to claim 9, The first port (4) is an administration port, the seal member (42) is adapted to be pierced by a spike of an administration device selected from the group consisting of an infusion set, a blood transfusion set, and a transfer device, thereby providing a fluid connection between the interior of the fluid container (100) and the administration device; the infusion set is an infusion set according to ISO 8536-4, the blood transfusion set is a blood transfusion set according to ISO 1135-4, and the transfer device is a transfer device according to ISO 22413, and / or The second port (5) is a needle-free port, the second port (5) is a medication port adapted to provide a fluid connection between the interior of the fluid container (100) and a fluid handling device, which is a syringe having a male connector according to any subpart of the ISO 80369 series of standards; and / or The valve housing (51) is integrally formed with the body (2) and / or The port housing (41) is integrally formed with the main body (2). A cap characterized by:

12. A cap (1) according to claim 9, The cap (1) is (i) an outer surface (421) of the seal member (42) is substantially flush or entirely flush with an outer peripheral surface (412) of the port housing (41); (ii) the outer surface (421) of the seal member (42) has a concave portion indicating a puncture point, and is substantially or entirely flat apart from the concave portion; (iii) the sealing member (42) is made of at least one thermoplastic elastomer selected from the group consisting of a styrene-based block copolymer, a thermoplastic polyolefin elastomer, a thermoplastic vulcanizate, a thermoplastic polyurethane, a thermoplastic copolyester, and a thermoplastic polyamide; (iv) the sealing member (42) is made of an elastic material having a hardness between 25 Shore A and 55 Shore A; (v) the body (2) comprises a polymer material having a tensile and / or flexural modulus of at least 700 MPa; (vi) the first port (4) and the second port (5) are arranged such that an administration device and a fluid handling device can be simultaneously connected to the first port (4) and the second port (5), respectively; (vii) the first port (4) and the second port (5) are disposed at an angle; the first port (4) and the second port (5) are arranged such that the angle between the direction of insertion of the administration device into the first port (4) and the direction of insertion of the fluid handling device into the second port (5) is between 15 degrees and 45 degrees, or between 25 degrees and 35 degrees; (viii) the angle between the direction of insertion of the administration device into the first port (4) and a direction perpendicular to the opening formed by the container connection portion (3) is between 0 and 30 degrees, or between 0 and 10 degrees; A cap characterized by any one of the structural features (i) to (viii), either alone or in combination:

13. A cap (1) according to claim 9, a peel-off foil (44) is arranged on top of the sealing member (42) as seen from the insertion direction of the administration device and is welded to the port housing (41); and / or a release foil (54) is arranged on top of the valve member (52) as seen from the insertion direction of the liquid handling device and is welded to the valve housing (51); a peeling foil (44, 54) arranged on top of the sealing member (42) and / or on top of the valve member (52) sealing the first port (4) and / or the second port (5), respectively; and / or a peel foil (44, 54) disposed on top of the seal member (42) and / or on top of the valve member (52) to provide tamper evidence; A peel-off foil (44, 54) disposed on top of the seal member (42) and / or on top of the valve member (52) provides sealing and integrity prior to use. A cap characterized by:

14. A fluid container (100) for a medical fluid (300), comprising: a hollow container body (200) having an opening (201); A cap (1) according to claim 9, wherein the body (2) of the cap (1) is fluid-tightly connected to the opening (201). Equipped with The container body (200) is (i) the container body (200) is a semi-rigid container body (200); (ii) the container body (200) is foldable; (iii) the container body (200) comprises a polyolefin material, and at least the wall of the container body (200) is made of polypropylene and / or polyethylene; (iv) the container body (200) is at least partially filled with a medical fluid (300); (v) the container body (200) is manufactured using extrusion blow molding, injection stretch blow molding, or blow-fill-seal technology; (vi) The container body (200) is a foldable flexible bag made of a multi-layer film. A fluid container characterized by having any one of the following structural features (i) to (vi), either alone or in combination:

15. A method for manufacturing a cap (1) for a container (100) for a medical fluid (300), comprising the steps of: The cap (2) comprises a body (2), a first fluid port (4) having a port housing (41) and a resilient seal member (42), and a second fluid port (5) including a valve (5) having a valve housing (51) and a resilient valve member (52); The above method is A) manufacturing or providing the body (2), the port housing (41), and the valve housing (51), wherein the body (2) is integrally formed with at least one of the port housing (41) and the valve housing (51); B) overmolding the seal member (42) into the port housing (41); C) overmolding said valve member (52) into said valve housing (51); D) placing a release foil (44, 54) on top of said seal member (42) and / or on top of said valve member (52); Including, Steps B and C are performed at least partially simultaneously; and / or The seal member (42) and the valve member (52) are formed as a single volume joined by at least one sprue (6). A method comprising:

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