Patent Application
20240216223
The present invention relates to a cap for a fluid container, fluid container comprising such cap and method for manufacturing such cap.
For therapeutic purposes, infusions and 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 pharmaceuticals) into the bloodstream of a patient. For this purpose, the fluid to be administered is taken from a fluid container and flows through an infusion tubing to the intravenous access. The intravenous access can for instance be provided by a peripheral cannula inserted into the patient's median cubital vein. Through the intravenous access, the fluid enters the patient's bloodstream.
An intravenous administration set (also known as “IV administration set”, “I. V. administration set”, “IV set”, “infusion set”, etc.) includes a flexible tube through which the fluid can flow from the container to the intravenous access. An intravenous administration set is a typical example of an administration device, i.e. a device used for administering a therapeutic fluid to a patient. Often, but not necessarily, the intravenous administration set includes a drip chamber connected to the tube so that the fluid flows from the container through the drip chamber into the tube. The intravenous administration set may optionally include further components, for example a flow regulator such as a roller clamp to control the flowrate of the liquid.
If a drip chamber is present, the drip chamber is connected to the container via a container connection so that the liquid can flow from the container into the drip chamber. Otherwise, the tube is directly provided with a container connector.
The container connector can be a piercing device such as a hollow mandrel which can pierce a septum of the container and which has one or more fluid channels in its interior. Such a piercing device is generally referred to as a “piercing spike” or “spike”.
A “septum” is a container closure in the form of a membrane or comprising a membrane, wherein the membrane is a rubber membrane or a membrane made of another suitable elastic material. Often, the membrane has the form of a disk inserted into a housing to close its opening. A symmetrical design, e.g. a cylindrical design, is preferred in view of a simple production process because a symmetrical membrane can be inserted in multiple orientations. The membrane is pierced with a hollow piercing device in order to remove fluid from the container or to introduce a fluid into the interior of the container. The piercing device may be a spike as described above, an injection needle, etc. Preferably, the membrane has self-sealing properties. That is, when the piercing device is pulled out of the membrane, the opening pierced by the piercing device, i.e. the puncture hole, closes at least partially, preferably completely. The membrane of a septum usually has no pre-fabricated opening in the form of a hole or slit into which the piercing device is inserted.
A “fluid” is understood to be a flowable material, in particular a liquid or a suspension.
A container access is generally referred to as “port” in the context of medical fluid containers. A port is therefore a container connection site to which an external device for fluid extraction or fluid addition may be connected in order to establish a fluid connection between the interior of the container and the external device. The port to which the intravenous administration set can be connected is called “administration port”.
Medical fluid containers are containers which are intended to contain medical fluids and are made of a material suitable for this purpose. Medical fluids include liquid pharmaceuticals for therapy or diagnosis, liquid pharmaceutical components, nutrients, blood for transfusion, etc.
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. Besides, plastic bottles with a certain degree of flexibility or plastic bags have become established on the market. Plastic not only has the advantage of having a lower specific weight and being less fragile than glass. If a sufficiently flexible plastic is used, a further advantage is that the container collapses when liquid is removed. This means that the volume of the container continuously adapts to the decreasing volume of the liquid in its interior so that no additional pressure equalization measures in the form of an air inlet channel or an air inlet opening are required. This not only simplifies the design of the administration device but also avoids the risk of contamination of the interior of the container by incoming air.
Some of the containers available on the market containing fluids for intravenous administration allow the addition of other drugs (so-called “drug admixture”). For example, the admixture is carried out by injecting the drug via a further port (so-called “medication port”) on the container which also includes a septum. That is, the drug is injected by means of an injection syringe fitted with a hollow needle, wherein the needle is pierced through the septum. Usually, the medication port is located at a position on the container close to the position of the administration port. This may make it easier to manufacture the container but more difficult or even impossible to connect a syringe or other fluid manipulation device to the medication port and, at the same time, a piercing spike or other piercing device to the administration port.
Containers for infusion liquids made of a polyolefin material are available on the market. These containers have a cap on the container head. During infusion, the container points downwards. The cap may have a single septum that may have identified piercing points as described, e.g., in the international standard ISO 15759. The cap may have two ports next to each other. A cap of this type is also called a “twin port cap”. The two ports may be of the same design. It is also possible that the cap has two septa that are different from each other, either with respect to their material or their design, as shown, e.g. in US 2009/0054865 A1. Each port comprises a septum which may be pierced by the spike of an intravenous administration set or a needle of an injection syringe. The user may deliberately choose which one of the two ports is used as the administration port and which one as the medication port. It is also possible that one of two functionally identical or functionally equivalent ports is intended as the administration port, whereas the other port is intended as medication port, wherein the different intended use may be indicated by using labels, symbols, different colours, etc. For practical reasons, the caps used for medical containers have a limited diameter, which makes the simultaneous connection of medication and administration device difficult or impossible in the case of the known caps.
The injection of a liquid into the container by means of an injection syringe may be cumbersome because a suitable injection needle has to be kept in stock, unpacked, connected to the injection syringe before use and discarded after use. Further, piercing the needle is prone to incorrect handling. In particular if the piercing direction is not vertical to the septum, the injection needle may be bent and thereby damaged and/or the septum may not seal completely after the injection needle has been withdrawn. In addition, handling an injection needle involves a potential risk of injury. If the drug admixture is carried out during the infusion, when the container is then placed upside-down, the port for injecting the drug to be admixtured may be difficult to access. Moreover, the needle is held only in the area of the puncture through contact with the septum material so that the needle and the syringe can be pulled out or fall out unintentionally.
From DE 10 2007 005 407 A1, a cap for a container for medical liquids is known which has an admixture portion and a withdrawal portion. The withdrawal portion has a pierceable membrane through which a spike of an intravenous administration set can be pierced in the conventional manner. The admixture portion is designed to receive the male cone of a syringe. The admixture portion does not have a septum but a slit valve, i.e. a membrane which has a slit that is opened by the inserted male syringe cone. The cap of DE 10 2007 005 407 A1 and especially the admixture portion (slit valve) and the withdrawal portion (septum) are difficult to clean and disinfect. Hence, germs, endotoxins, disinfectants, etc. may remain and increase the risk of contaminating the liquid prior to its administration to a patient. Moreover, the admixture portion and the withdrawal portion are close to each other and point into the same direction so that simultaneous drug admixture and intravenous administration of the liquid are difficult or impossible. Moreover, the openings of the administration portion and the withdrawal portion are sealed by break-off parts which are complicated to manufacture and cumbersome to handle. Moreover, the liquid is in contact with the septum during storage prior to use, which carries the risk that components of the septum migrate into the liquid. Furthermore, the elastic elements (septum and slit valve) cannot be mounted from the outside. A valve with a valve opening formed by a slit that is cut in an elastic stopper or the like may be seen as a particular uncomplicated construction of a valve. However, it may be difficult to introduce a syringe cone into such a slit and the fluid-tightness of the connection between the male connector and such a slit might be low, in particular if the male connector is too large or too small for a specific slit. Moreover, the fluid-tightness of such a slit after withdrawal of the male connector, i.e. the re-sealing properties, may be low, in particular as a consequence of overstretching or wearing out the slit.
In view of the situation described above, an objective of the present invention is to provide an improved cap for a medical fluid container, in particular a cap that is improved with respect to at least one of the above-mentioned properties of the prior art caps, an improved medical fluid container, in particular an improved container for an infusion liquid, and an improved method for manufacturing the cap.
Any feature set forth in the description of exemplary embodiments of the invention below can be understood as a feature suitable for refining the cap, the fluid container, and the method. If possible from a technical point of view, the features of all described embodiments may be combined with one another.
The cap according to the invention is a cap for a fluid container. In particular, the cap is a cap for a container for a medical fluid. 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 first port housing. The first port housing comprises a first opening. The first port further comprises an elastic first seal member accommodated in the first port housing and sealing the first opening. The first seal member is formed as a pierceable septum. The outer surface of the first seal member is essentially flush or entirely flush with an edge surface of the first opening. The second port comprises a second port housing. The second port housing comprises a second opening. The second port further comprises an elastic second seal member accommodated in the second port housing and sealing the second opening. The second seal member comprises a valve opening configured to provide a fluid-tight connection with a fluid manipulation device.
Herein, the ordinal numbers “first” and “second” are used to denote those elements that belong to the first port and the second port, respectively, i.e. the “first port housing” is the housing belonging to the first port, etc.
Preferably, the first seal member comprises or is made of an elastomeric material.
Preferably, the second seal member comprises or is made of an elastomeric material.
The cap is adapted to be connected to a container body, i.e. a hollow body with an opening such as for instance a bottle. Whereas a bottle or the like is sometimes referred to as a container, it is referred to as a “container body” here because the expression “container” is used for the capped device in the context of the present invention. Hence, the assembly of the container body and the cap connected thereto is referred to as “container” or “fluid container”. For connecting the cap to the container body, the container connection portion of the cap is connected to an opening of the container body which is referred to as its “mouth”. The connection between the cap and the container body may for instance be achieved by fixing the connection portion of the cap to a wall portion of the container body defining its mouth such as a neck portion. It is also possible that the connection portion of the cap is fixed to an intermediate part connected to the container body, in particular a molded transition part. For instance, such transition part may be connected on one of its sides to a flexible bag and on its other side to the cap. The cap might have a substantially oval connection portion that is meant to be welded to a base of the port that has a matching receiving distal portion on one side and an almond shaped proximal portion on the other side to be welded on the inner side of plastic films of a bag.
For connecting the cap to the container body, various techniques may be used such as, e.g. welding, gluing, and/or screwing. The mouth allows access to the inside of the container body. Apart from the mouth, the container body may comprise further access sites. The shape of the container connection portion of the cap and the portion at the opening of the container body are complementary, so that there is preferably a fluid-tight connection between the container and the cap.
The first seal member is formed as a pierceable septum. A septum is a closure typically comprising 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 piercing device may also be referred to as “puncture device”. The septum seals the first opening, i.e. under normal conditions of use, no fluid can flow through the first opening if the septum has not been pierced by a piercing device. If the septum is pierced by a hollow piercing device, the fluid can flow through a channel within the hollow piercing device, wherein preferably the material of the septum at the piercing site is tight against the outer surface of the piecing device so that no fluid can flow alongside the piercing device but exclusively through the channel of the piercing device. Preferably, the septum is self-sealing, i.e. a channel formed by the piercing device in the material of the septum automatically closes after the piercing device has been withdrawn from the septum, at least if it is pierced by a piercing device up to a certain maximum diameter. This self-sealing function can be achieved for instance by selecting a suitable elastic material. The self-sealing property may also be referred to as “resealing” property.
The outer surface of the first seal member is essentially flush or entirely flush with an edge surface of the first opening.
The outer surface of the first seal member (septum) is the surface which points towards the outside when the cap is connected to a container body, i.e. the surface which does not point towards the inside of the container and which also does not abut the housing. If the cap or the container comprising the cap is oriented so that the first port is at the top, the outer surface may also be referred to as the “top surface” of the first seal member. The outer surface may also be referred to as the “distal surface” of the first seal member.
The expressions “distal” and “proximal” mean closer to and, respectively, further away, from the interior of the container body in an assembled state in which the cap is connected to the container body. In preferred embodiments, the body of the cap has a hat-like structure. The concave side is also referred to as “proximal side” or “inner side” (i.e. the side that points towards the interior of the container if the cap is connected to a container body). The convex side is also referred to as “distal side” or “outer side”. In a similar manner, the body's surface on the concave side is also referred to as “proximal surface” or “inner surface” etc.
The edge surface is that portion of the surface of the first port housing which surrounds the inside width of the opening. Therefore, the edge surface defines the border of the opening. If, for instance, the first port housing is formed as a cylindrical or conical protrusion protruding from the body of the cap, the edge surface corresponds to the distal end surface of the first port housing, which may also be referred to as “front surface”. The edge surface may have the shape of a circular or elliptical ring or a different circumferential shape.
In preferred embodiments, the first port housing is formed as a hollow protrusion protruding from the remaining body of the cap. The first seal member is accommodated in the hollow protrusion. The edge surface, viewed in a distal-proximal direction, is the front surface of the protrusion.
The outer surface of the first seal member is entirely flush with the edge surface of the first opening, if these two surfaces merge continuously into each other so that, along the entire circumference of the first seal member, no step is formed in the area where the surface of the first seal member and the surface of the first port housing meet each other. This means that the outer surface of the first seal member is in alignment with the edge surface of the first opening. In other words, this means that the outer surface of the first seal member transitions smoothly into the edge surface of the first port housing. The outer surface of the first seal member is essentially flush with the edge surface of the first opening, if a step of 1.5 mm or less, preferably 1.25 mm or less, more preferably 1.0 mm or less, most preferably 0.25 mm or less is formed. In other words: The outer surface of the first seal member is entirely flush with the edge surface of the first opening, if neither surface projects nor recedes relative to the other surface. The outer surface of the first seal member is essentially flush with the edge surface of the first opening, if one of the surfaces in question projects or recedes relative to the other surface by a small offset (1.5 mm or less). It is also possible that the surfaces merge continuously into each other 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 situation may also be referred to as “essentially flush”.
Due to the alignment of the outer surface of the first seal member and the edge surface of the first opening, which are entirely flush or essentially flush with one another, the process of disinfection of the first seal member is made easier and safer. Because no significant discontinuous surface structure such as a step is present in the area to be disinfected, an effective disinfection by applying a disinfectant by rinsing, spraying, wiping, or other application technique can be achieved. The disinfectant can efficiently reach the entire area to be disinfected. This prevents pathogens and other contaminants from accumulating in a surface discontinuity and thus prevents 20) the accumulation of contaminants that cannot be removed effectively or cannot be removed at all by the application of a disinfectant. In addition, a cavity is avoided in which disinfectant could accumulate after application. Such an accumulation of disinfectant (“disinfectant pool”) is unfavourable when using the cap or a container with such cap because either it is necessary to wait for the evaporation of the disinfectant after disinfection and before piercing through the septum with the piercing device, or there is a risk that disinfectant is carried through the septum together with the piercing device and could thus enter the patient's bloodstream. Further, other debris (various particulate matter, pathogens, dirt, dead organisms, etc., in particular matter that cannot evaporate) is carried through the septum together with the piercing device and could thus enter the patient's bloodstream. Moreover, the disinfection carried out in the course of the production of the cap or the container may be easier or more efficient due to this alignment of the outer surface of the first seal member and the edge surface. In addition, a quick disinfectant evaporation may be beneficial in view of production time and it may avoid that disinfectants are trapped between the septum and a sealing foil applied thereon after disinfection. Disinfectants usually are organic solvents such as ethanol or isopropanol. Such organic solvents could damage the septum in particular if trapped between the septum and the foil. A quicker and more efficient radiation-based disinfection may also be achieved due to an entirely or essentially flush alignment because shadow areas are avoided or minimised.
With regard to disinfection efficiency, it is preferred that the outer surface of the first seal member and the edge surface of the first opening are arranged in an entirely flush manner.
However, an only essentially flush alignment, for instance with a small offset of 1.0 mm to 1.5 mm, is sufficient, or even might be preferred with regard to the robustness of the process of assembling the septum and the first port housing. Such small offset, if present, is tolerable with regard to disinfection efficiency.
Due to the provision of both ports on the same base part (body), an efficient fabrication of fluid containers is possible because the container body has to be connected to only one part. In addition, the body may be adapted to different container mouth shapes.
The second seal member comprises a valve opening configured to provide a fluid-tight connection with a fluid manipulation device. A fluid manipulation device is a device with which fluid such as a liquid can be removed from the container or with which fluid can be added to the container. The fluid manipulation device may be, for example, a syringe without a needle attached. The valve opening is configured to be connected to the male connector of the fluid manipulation device. Fluid transfer is then possible between the interior of the container body connected to the cap and the fluid manipulation device. Preferably, the connection between the male connector of the fluid manipulation device and the valve opening is fluid-tight, i.e. fluid can flow through the valve exclusively via the male connector of the fluid manipulation device. In other words, the connection between the fluid manipulation device and the valve opening is fluid-tight if it does not leak, i.e. the material around the valve opening is tight against the outer surface of the male connector of the fluid manipulation device.
The configuration of the valve opening depends on how the male connector of the device with which a connection is intended is formed. For example, the device may be a needleless syringe provided with a male connector in form of a cone or another male mating member. If the connection with such a syringe is to be possible, the valve opening may be, for example, a slit into which the male mating member is inserted to make the connection. The cone of a syringe may correspond to the standardised Luer geometry or deviate from the Luer geometry. Preferably, the valve opening is designed in such a way that a fluid-tight connection with differently designed male connectors is possible, e.g. with male Luer cones or different male mating structures.
According to embodiments of the invention, the valve opening is formed as a slit intended to be penetrated by a male connector.
According to other embodiments, the second seal member is configured such that the male connector does not penetrate the slit by expanding it and sliding in but deforms the upper surface of the second seal member in a way the slit opens. Herein, the second seal member preferably comprises elastic portions that are folded inwards or rolled inwards by the male connector in order to make an opening when the male connector is pushed against the second seal member. Due to their elasticity, these elastic portions then preferably tightly enclose the male connector such that the male connector is tightly inserted in the opening. Moreover and also due to their elasticity, these elastic portions preferably tightly close the opening again after the male connector has been pulled out of the opening. Using a second seal member having such a configuration, the insertion and/or the withdrawal of the male connector may be particularly easy. Moreover, such a configuration may be usable with a relatively wide variety of sizes of the male connector. In addition, such a configuration may have a good resistance to overstretching and wear and therefore good sealing properties, preferably also after multiple connections with a male connector.
In order to support the tight connection with an inserted male connector and/or the tight closure after withdrawal of the male connector and in particular to help the slit to close faster during withdrawal of the male connector, further elastic structures may be provided such as for instance ribs that exert an elastic force which keeps the opening tightly closed when no male connector is present and which presses the inner walls of the opening tightly against the male connector when it is in the opening. Such ribs may for example be provided in the case of a second seal member that is configured such that the male connector penetrates the slit by expanding it and sliding in. Such ribs may for example also be provided in the case of a second seal member that comprises elastic portions that are folded inwards or rolled inwards when the male connector is pushed against the second seal member.
Preferably, the valve opening is resealable, i.e. after disconnecting the fluid manipulation device, the valve opening automatically closes such that the second seal member seals the second opening in a fluid-tight manner again.
In preferred embodiments, the first port is an administration port, i.e. a port for withdrawing a liquid that is to be administered to a patient from the container body connected to the cap. For instance, the first seal member is adapted to be pierced by a spike of an administration device such as an infusion set, a transfusion set, a transfer device etc. By piercing the first seal member by the spike, a fluid connection between the interior of the container body connected to the cap and the administration device is established.
In addition or alternatively, in further preferred embodiments, the second port is a needle-free port, i.e. a port through which a fluid connection with a syringe that is not provided with a needle or a similar device can be made. In other words, the second port is in this case not intended to be pierced by a needle or another device in order to provide a fluid connection via the second port.
In preferred embodiments of the invention, the second port comprises a valve member and constitutes a needle-free port, preferably a medication port adapted to provide a fluid connection between the interior of a fluid container and a fluid manipulation device such as a syringe having a male connector, more preferably a male connector according to any sub-part 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. If the second port is such a needle-free port, it is ensured that the cap is particularly suitable as the cap of a fluid container for infusion or transfusion therapy with the possibility of drug admixture using conventional fluid manipulation devices such as a conventional syringe without a needle.
The valve member comprises a valve opening, wherein the valve opening is configured to be closed when the valve is in the closed operating state, and to provide fluid passage through the valve when the valve is in an open operating state.
The valve may be configured to be in an open operating state only after the tip of a mating connection device has been inserted into the valve opening. In particular, the valve is in its closed operating state if no fluid manipulation device is connected thereto, and in its open operating state if an appropriate fluid manipulation device such as for example a syringe is connected thereto.
It is preferred that the fluid connection between the interior of the container body connected to the cap and the syringe or the other fluid manipulation device is a bidirectional fluid connection, i.e. fluid can flow through the valve opening either into the container body or out of the container body.
In preferred embodiments, the distal surface of the valve is flush or essentially flush with the distal end of the second port housing, i.e. it transitions entirely smoothly or essentially smoothly into the edge surface of the second port housing.
In addition or alternatively, in further preferred embodiments, the first seal member and/or the second seal member is overmolded onto the body of the cap. Overmolding is a method in which a material is added to an already existing object by molding in order to produce an assembled product. The already existing object may be an object produced by injection molding or any other production technique.
In order to manufacture an overmolded seal member, the respective housing is preferably molded at first. In a second step, the seal member, which is made of a more flexible material, is injection-moulded into the already produced housing that has been placed in an injection mold which may have inserts specifically designed to shape the seal member. In some areas, the material used to shape the seal member reaches the inner wall of the housing in a hot molten state and gets bonded to it by fusion of the materials. Due to the overmolding, the seal member tightly adheres to the inner wall of the housing such so that there is no remaining gap between the seal member and the housing in said areas. The housing is molded at first because it is made of the stiffer material and will better withstand the pressure and temperature that will be created during the injection molding of the seal member.
Due to the absence of a gap between such an overmolded seal member and the housing, the risk of leakage may be reduced or even avoided. Moreover, also the risk of contamination may be reduced or even avoided. Moreover, due to the tight bond between the overmolded seal member and the housing, the risk that the seal member could be inadvertently dislodged from the housing when a syringe cone or the like is inserted may be reduced or avoided.
Due to the absence of a gap between such an overmolded seal member and the housing, bacteria and other contaminant are less likely to accumulate. It may even be possible to manufacture a clean and sterile elastic member without an additional step of sterilisation using radiation or the like.
By using overmolding, the number of pre-fabricated components may be reduced compared to conventional ports. This may reduce the number of assembly steps and manipulations. This may on the one hand improve the efficiency of the manufacturing process. This may on the other hand reduce the risk of component defects and/or contamination.
In addition, the use of a thermoplastic elastomer may be possible. Thermoplastic elastomers have excellent material properties and often are recyclable.
An overmolded seal member may be distinguished from a seal member that was, e.g., mounted in a press-fitting or form-fitting manner in that the material of the overmolded seal member and the material of the housing are bonded together in the contact area resulting in a tight and gap-free connection.
An overmolded seal member may be distinguished from a seal member that was fixed to the housing by using an adhesive in that, between the material of the overmolded seal member and the material of the housing, no adhesive is present.
In addition or alternatively, in further preferred embodiments, the outer surface (distal surface) of the first seal member is essentially flat or entirely flat. Herein, the outer surface is considered to be essentially flat if it has protrusions and/or recesses whose height is less than 10% of the largest diameter of the outer surface. For instance, it is possible that the outer surface has such a recess in order to indicate the location where the user should pierce the first seal member.
Preferably, the diameter of the first seal member (measured transversely to the direction in which it is pierced) is large enough such that the elastic material in the space between a piercing device such as a spike pierced through the first seal member and the first port housing does not need to be squeezed upon insertion of the piercing device thus preventing high friction to the piercing device being inserted and allowing for easy insertion of the piercing device.
Preferably, the diameter of the first seal member (measured transversely to the direction in which it is pierced) is small enough such that a sufficient force for holding the piercing device is ensured.
Preferably, the diameter of the first seal member (measured transversely to the direction in which it is pierced) is larger than the diameter of the first port housing such that a radial compression of the elastic material results in order to improve resealability after disconnection of the piercing device.
In addition or alternatively, in further preferred embodiments, the second seal member has a diameter measured transversely to the direction in which it is pierced of at least 8 mm, preferably at least 9.5 mm and/or 18 mm or less, preferably 13 mm or less.
The first seal member may also have a non-circular shape. It may, e.g., be elliptical. The above-mentioned preferred diameters are then understood as the smaller dimension of the non-circular shape, e.g. the shorter axis of an ellipse.
Preferably, the thickness of the first seal member (measured in the direction in which it is pierced) is chosen to ensure sufficient resealability and sufficient force for holding the piercing device, and to avoid excessive force for the insertion of the piercing device.
In addition or alternatively, in further preferred embodiments, the thickness of the first seal member measured in the direction in which it 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 material of the first seal member is chosen to ensure sufficient resealability and sufficient force for holding the piercing device, and to avoid excessive force for the insertion of the piercing device.
In addition or alternatively, in further preferred embodiments, the first seal member comprises
In addition or alternatively, in further preferred embodiments, the first seal member comprises an elastic material having a hardness between 25 and 55 shore A.
In addition or alternatively, in further preferred embodiments, the first seal member comprises an elastic material including pigments and/or dyes capable of absorbing electromagnetic radiation. The presence of substances having the ability of absorbing electromagnetic radiation may for instance improve the usability of laser welding for connecting the first seal member to the first port housing.
In addition or alternatively, in further preferred embodiments, the diameter of the second seal member (measured transversely to the direction in which the fluid manipulation device is connected to the second port) is 18 mm or less, preferably 13.5 mm or less.
The second seal member may also have a non-circular shape. It may, e.g., be elliptical. The above-mentioned preferred diameters are then understood as the smaller dimension of the non-circular shape, e.g. the shorter axis of an ellipse.
In addition or alternatively, in further preferred embodiments, the length of the second seal member (measured in the direction in which the fluid manipulation device is connected to the second port) is between 10 and 15 mm and/or longer than the cavity in which it is accommodated to create an axial pre-load to ensure (1) sufficient elastic force such that the second seal member returns to its initial position when the fluid manipulation device is disconnected and (2) sufficient sealing. Herein, the force that the user has to exert onto the fluid manipulation device in order to connect the same to the second port should be moderate for the sake of good usability.
In addition or alternatively, in further preferred embodiments, the second seal member comprises a distal wall in which the valve opening is formed and a blind hole open at the proximal portion of the second seal member and terminating at the distal wall such that the interior of the blind hole is in communication with the valve opening. By using such a design for the second seal member, it may for instance be possible that a second seal member is provided which comprises elastic portions that are folded inwards or rolled inwards by the male connector in order to make an opening when the male connector is pushed against the second seal member, wherein these elastic portions then tightly enclose the male connector such that the male connector is tightly inserted in the opening. More preferably, these elastic portions tightly close the opening again after the male connector has been pulled out of the opening.
Preferably, the thickness of the distal wall is 1 mm or more and 6 mm or less. A thinner wall would possibly be less suitable in view of resealability and tightness, especially under pressure conditions. A thicker wall could be more complicated for production and cost more. More preferably, the wall thickness is between 1 mm and 3 mm.
Preferably the diameter of the blind hole is 2 mm or more to ensure proper fluid flow. More preferably, the diameter of the blind hole is 2.5 mm or more.
Preferably, the material of the second seal member is selected to ensure (1) easy connection with the fluid manipulation device, (2) sufficient force such that the second seal member returns to its initial position when the male connector is disconnected, (3) resilience, i.e. minimum change of material properties, even after repeated connection of a fluid manipulation device, (4) high tear resistance to prevent tearing upon insertion of the male connector.
In preferred embodiments the second seal member comprises
In addition or alternatively, in further preferred embodiments, the second seal member comprises an elastic material having a hardness between 25 and 55 shore A.
In addition or alternatively, in further preferred embodiments, the body comprises a polyolefin, preferably polypropylene and/or polyethylene.
In addition or alternatively, in further preferred embodiments, the body comprises a polymer material having a tensile modulus and/or flexural modulus of at least 700 MPa.
In addition or alternatively, in further preferred embodiments, the second seal member provides a fluid-tight connection with the fluid manipulation device, in particular a releasable connection such that the fluid-tight connection and disconnection of a fluid manipulation device is possible multiple times.
In addition or alternatively, in further preferred embodiments, the valve opening is self-sealing, i.e. the valve automatically closes after the male connector (e.g. syringe cone) of the fluid manipulation device has been disconnected. Such self-sealing valve opening may also be referred to as “resealing valve opening”. Preferably, the self-sealing property is provided or improved by preloading the second seal member by an elastic deformation providing a spring force causing the valve opening to close after the male connector has been withdrawn from the valve opening. The preloading may have an axial force component, i.e. a force component in the direction in which the male connector of the fluid manipulation device is inserted. The axial force component may be provided by choosing the axial dimensions of the second port housing and the second seal member such that the former is shorter than the latter resulting in an axial compression. Alternatively or additionally, the preloading may have a radial force component, i.e. a force component perpendicular to the axial direction. The radial force component may be provided by a conical structure of the inner surface of the second port housing and/or by a lumen of the inner surface of the second port housing that is smaller than the dimensions of the outer surface of the second seal member.
In addition or alternatively, in further preferred embodiments, the second port is formed as female mating connector, i.e. it is adapted to be connected to a male mating connector used as connection part of the fluid manipulation device. The male mating connector may, for instance, be a connector designed according to any sub-part of the ISO 80369 series of international standards, in particular a male Luer connector according to ISO 80369-7, a male connector according to ISO 80369-6, or a similar design. The connection system according to ISO 80369-6 is also referred to as NRFit®. Preferably, the female mating connector is formed in a way to allow tight connection with such a male connector. Connector geometries different from the Luer geometry are, however, also possible.
The second port housing may comprise a thread structure, preferably a thread structure adapted for connecting with a male Luer lock structure.
In addition or alternatively, in further preferred embodiments, at least a portion of the second port housing is formed as a separate housing element connected to the body of the cap, i.e. the separate housing element is not formed monolithically with the body of the cap. The second seal member is at least partially accommodated in the separate housing element. The separate housing element is connected to the body, preferably in a permanent manner. In this context, a permanent connection is a connection that can only be disconnected in a destructive manner. For the connection of the separate housing element, a connection socket formed monolithically with the body of the cap may be provided. More preferably, the separate housing element is permanently connected to the body (in particular to the socket, if present) by welding, e.g. to the connection socket.
Preferably, the cap further comprises a membrane. Preferably, the membrane is formed of the same material as the body of the cap, in particular monolithically with the body of the cap. The membrane is arranged underneath the first seal member seen in a direction of insertion of a piercing device, wherein the membrane is adapted to be pierced by the same piercing device that penetrates the first seal member. That is, when the piercing device is connected to the fluid container, it penetrates the first seal member and, subsequently, the membrane. Such membrane may have the ability to prevent contact between the liquid and the first seal member in order to prevent that components of the first seal member are leached and migrate into the liquid prior to use.
The properties of the membrane such as its material and its thickness are selected such that the tightness is on the one hand sufficient during transportation, storage, and manipulation prior to use and on the other hand not too high in order to avoid excessive force required for connecting the piercing device to the container.
In more preferred embodiments, the membrane has a thickness of 0.1 mm or more, particularly 0.15 mm or more and/or 0.5 mm or less, particularly 0.25 mm or less.
Preferably, the cap has a height between 12 mm and 50 mm, more preferably between 14 mm and 30 mm, measured in a direction transverse to the mouth of the container body 200 with which the cap 1 is to be connected. Such height may be seen as a compromise between a user-friendly handling and a low residual volume within the cap 1 and space requirements during transport and storage.
According to preferred embodiments of the invention, the first seal member is accommodated in a seat structure at the distal end of the first port housing and held in place by means of a fastener attached to the distal end of the first port housing.
In the course of the production of a cap of one of the aforementioned embodiments having a separate housing element for the second port, it is possible that the second seal member is mounted by approaching the second seal member from the distal side and putting the separate element over the second seal member. The direction “from the distal side” is the direction corresponding to the direction in which the male connector of the fluid manipulation device is inserted into the second port. Mounting from the distal side may be less complicated than from the opposite side, in particular if the cap has a concave shape so that the mounting tools can reach the distal side more easily. In addition, only by mounting from the distal side, it is possible to mount the second seal member after the cap has already been connected to the container body which may improve the flexibility of the production process.
The fluid container according to the invention, which in particular is a fluid container for a medical fluid, comprises
The body of the cap is in fluid-tight connection with the opening portion.
The fluid container may comprise a cap of any one of the embodiments of the invention.
The method according to the invention is a method of manufacturing a cap according to the invention. The method comprises the steps:
Herein, the first seal member may be mounted after or before the second seal member. It is also possible that both seal members are mounted at least partially simultaneously in order to save production time.
Mounting of a seal member includes inserting into the respective port housing and, preferably, fixing it in place. For instance, laser welding can be used to fix the first seal member in place. For instance, a form-fit connection by the second port housing may be used to fix the second seal member.
Alternatively, the first seal member and/or the second seal member may be manufactured in an in-situ manner (i.e. simultaneously manufactured and mounted), in particular by overmolding it in the respective portion of the body.
Preferably, the first port is provided with a peel-off foil.
In addition or alternatively, preferably, the second port is provided with a peel-off foil.
Such a peel-off foil covers the distal end of the respective port.
The peel-off foil is removed before a piercing device is pierced through the first seal member and before a male connector is connected with the second seal member, respectively. The peel-off foil seals and protects the respective seal member, and in particular provides tamper evidence because the peel-off foil makes it easy to determine whether the seal member is damaged or has already been connected to a fluid manipulation device or an administration device, respectively. Furthermore, the peel-off foil provides additional tightness for the respective port and helps to ensure its mechanical integrity, for example, when the cap is subjected to mechanical stress. Compared to a break-off part, a peel-off foil is less subject to damage. This is due to its flat construction. Further, less material is needed for a peel-off foil. Further, the use of a peel-off foil leads to a shorter container, which is advantageous for storage and transportation.
For inserting the first seal member, preferably the first seal member is inserted into the first port housing from the distal side, i.e. in a direction corresponding to a direction in which a piercing device is inserted into the first port and fixed in place, e.g. by laser welding. In alternative embodiments, the first seal member may be inserted into the first port housing in the opposite direction, i.e. from the interior of the body.
For mounting the second seal member, preferably the second seal member is brought into position from the distal side, i.e. in a direction corresponding to a direction in which the male connector of a fluid manipulation device is inserted into the second port, wherein preferably the second port housing is attached atop the second seal member in order to fix the second seal member in place. In alternative embodiments, the second seal member may be inserted into the first port housing in the opposite direction, i.e. from the interior of the body.
In step A, the body may be provided or manufactured as a body connected to a container body, the latter optionally filled with a liquid, before the first seal member, the second seal member, or both seal members are mounted. In this case, it is especially beneficial or even necessary that the seal member(s) yet to be mounted can be inserted into the respective port housing from a distal side, because the port housings are not accessible for inserting the seal members from within the container. This in turn means that the cap according to the invention offers the advantage of being able to be processed in the course of manufacturing a container in such a way that the seal members can be mounted from the outside (from a distal side), which brings advantages in terms of the flexibility of the manufacturing process.
Other features and expediencies of the invention may be found in the description of exemplary embodiments with the aid of the appended drawings.
In
Preferably, the fluid 300 is a medical fluid such as a liquid drug. In other words, it is preferred that the container 100 is suitable to contain a medical fluid and suitable to be used in a medical environment.
Preferably, the container 100 is tightly closed if both ports are in their closed state, i.e. if neither an administration device nor a fluid manipulation device is connected to the respective port. In use, e.g. during administering an intravenous infusion, the container 100 is usually in an upside-down orientation, that is, the cap 1 is then located at the lowermost position so that the liquid 300 can flow from the container body 200 into the administration device connected to the first port 4. For adding a fluid to the inside of the container 100 through the second port 5 using a fluid manipulation device, in general no specific orientation of the container 100 is required.
The cap 1 comprises a body 2 constituting the main part of the cap 1. In the illustrated embodiment, the body 2 is shown as a hollow cup-like structure with
The elevated section and the protrusions are optional.
In the illustrated embodiment, the lower part of the cap 1 is circular because the cap 1 according to this embodiment is intended to be attached to a container body 200 with a circular opening 201. Other shapes of the lower part of the cap 1 are possible for other shapes of the opening, e.g. elliptical or rectangular with rounded corners.
In the illustrated embodiment, the connection portion 3 is shown to be a tapered ring-like portion of the inner surface of the cap 1. In other embodiments, the connection portion may include, for instance, a cylindrical inner surface portion, an inner surface portion with a step, a front surface at the lower edge of the cap 1, etc. It is also possible that the connection portion 3 is deformed when the cap 1 is connected to the container body 200, in particular if welding or another heat-involving process is used therefor.
The cap comprises two ports 4, 5. The first port 4 may, e.g., serve as administration port. The second port 5 may, e.g., serve as medication port.
Both ports comprise a port housing, wherein both port housings comprise a respective opening: The first port 4 comprises a first port housing 41 with a first opening 411 and the second port comprises a second port housing 51 with a second opening 511.
The openings 411, 511 provide access points for fluid transfer into or out of the container 100, if the cap 1 is connected to a container body 200. A fluid could flow through the first opening 411 or the second opening 511, if the first seal member and the second seal member, respectively, were removed from the port housings 41, 51. The seal members accommodated in the port housings 41, 51 ensure that fluid may only be transferred through the openings by using a piercing device and a fluid manipulation device, respectively. The seal members, the piercing device, and the fluid manipulation device will be described further below.
The piercing device and the fluid manipulation device are not part of the container according to the present invention.
In the embodiment shown in
In further embodiments, the cylindrical protrusion has a non-circular cross section, e.g. an elliptical cross section. In further embodiments, the protrusion is conical.
In further embodiments, the first port housing is not formed monolithically; instead, at least a portion of the first port housing is formed as a element that is attached to the remaining body of the cap, for instance by laser welding.
In the first port housing 41, an elastic first seal member 42 is accommodated. In the embodiment shown in
The first seal member 42 is formed as a pierceable septum 42 that may be pierced by a spike of an infusion set or another piercing device. That is, the septum 42 closes the first opening 411, if no piercing device has been pierced through the septum. If a hollow piercing device is pierced through the septum, a fluid can flow through the piercing device. In other words, the piercing device pierced through the septum acts as fluid entrance or fluid exit of a container 100 if the cap 1 is connected to a container body 200.
Preferably, the septum 42 is self-sealing, i.e. a channel formed by the piercing device in the material of the septum 42 automatically closes after the piercing device has been withdrawn from the septum 42.
The septum 42 before its insertion into the first port housing 41 is slightly larger than the inner dimensions of the port housing 41 and in particular slightly larger than the first opening 411 such that the septum 41 is compressed when accommodated in the first port housing 41 providing an elastic deformation. Such elastic deformation creates as force that improves the self-sealing properties of the septum 42. In addition, the elastic force may be used to hold the septum 42 in the first port housing 41. Alternatively or additionally, the septum 42 may be attached to the first port housing 41 by means of a suitable joining technique, e.g. welding (in particular laser welding), gluing, etc. In addition it is possible to form the septum 42 in situ, e.g. using a curable compound, wherein the compound adheres to the inner wall of the first port housing 41 in the course of curing.
In addition or alternatively, in further preferred embodiments, the septum 42 comprises a material including pigments and/or dyes capable of absorbing electromagnetic radiation in order to improve the usability of laser welding for connecting the septum to the first port housing 41.
Preferably, the size of the septum 42 measured transversely to the direction in which it is pierced is large enough such that the elastic material in the space between a piercing device such as a spike pierced through the septum 42 and the first port housing 41 does not need to be squeezed to much upon insertion of the piercing device thus preventing high friction to the piercing device being inserted and allowing for easy insertion of the piercing device. Further preferably, the size of the septum 42 measured transversely to the direction in which it is pierced is small enough such that a sufficient force for holding the piercing device is ensured.
In addition or alternatively, in further preferred embodiments, the septum has a diameter measured transversely to the direction in which it is pierced of at least 8 mm, preferably at least 9.5 mm and/or 18 mm or less, preferably 13 mm or less.
Preferably, the thickness of the septum 42 measured in the direction in which it is pierced is chosen to ensure sufficient resealability and sufficient force for holding the piercing device, and to avoid excessive force for the insertion of the piercing device. In addition or alternatively, in further preferred embodiments, the thickness of septum 42 measured in the direction in which it is pierced is 1.5 mm or more, preferably 2 mm or more and/or 5 mm or less, preferably 4 mm or less.
In specific embodiments, the first seal member 42 comprises
In addition or alternatively, in further preferred embodiments, the first seal member 42 comprises an elastic material having a hardness between 25 and 55 shore A.
In the embodiment shown in
In the embodiment shown in
The outer surface 421 (distal surface) of the septum 42 is flush with the edge surface 412 of the first opening 411.
That is, the edge surface 412 and the distal surface 421 of the septum 42 merge continuously into each other so that, along the circumference of the septum 42, no step is formed in the area where the first seal member and the first port housing meet each other.
If both the edge surface 412 and the distal surface 421 of the septum 42 are flat, the flush surfaces lie in the same plane. If, in alternative embodiments, the edge surface is tapered and/or rounded, the flush surfaces merge continuously into each other but do not lie in the same plane.
If the edge surface 412 is rounded (as shown in
In alternative embodiments, the septum 42 is not entirely flush with the edge surface 412, but only essentially flush, in particular in the sense that only a step of 1.5 mm or less, preferably 1.25 mm or less, more preferably 1.00 mm or less, most preferably 0.25 mm or less is formed between the septum 42 and the edge surface 412.
In the embodiment shown in
Specifically, the connection socket 50 is formed as a rim that projects beyond the surface of the body 2 in both directions. The connection socket 50 provides a proximal stop forming a retaining structure preventing the second seal member 52 from being pushed further into the interior of the body 2. The connection socket 50 provides a connection portion for the connection with the bushing 50a. In alternative specific embodiments, the connection socket 50 does not project beyond the surface of the body 2 either on its distal side or its proximal side.
In alternative embodiments, no connection socket 50 is provided such that the bushing 50a is directly connected to the outer surface of the body 2.
In further alternative embodiments, the second port housing comprises a protrusion formed monolithically with the body 2 and protruding from the outer surface of the body 2. A distal element is connected to the protrusion so that the protrusion and the distal element together form the second port housing. The protrusion may be cylindrical with a circular or a non-circular (e.g. elliptical) cross section, conical, etc. The distal element holds the second seal member in place.
In further alternative embodiments, the second port housing 52 is in its entirety formed monolithically with the body 2.
However, it is preferred that the second port housing 52 comprises at least one separate element attached to the body 2, such as for instance a bushing 50a connected to a connection socket 50 or the outer surface of the body 2 or a distal element connected to a protrusion of the body 2.
By using a separate element, the mounting of the second seal member 52 can be made particularly simple, especially if the second seal member 52 is to be inserted into the second port housing 51 from the outside. The interior of the second port housing 51 may then offer a form-fitting accommodation of the second seal member 52 without the necessity that the second seal member 52 is forced through a small opening.
In the second port housing 51, the second seal member 52 is accommodated. In the embodiment shown in
The second seal member 52 comprises a valve opening 521 configured to provide a fluid-tight connection with a fluid manipulation device such as a syringe without a needle attached. The valve opening 521 is configured to be connected to the male connector of the fluid manipulation device such as a syringe. In the case of a typical syringe, the male connector is the tubular protrusion provided at the syringe's front surface. Preferably, the connection between the connector and the valve opening is fluid-tight.
In the embodiment shown in
If no fluid manipulation device is connected to the second port 5, the slit 522 is closed, i.e. the lateral surfaces (cut surfaces) of the slit touch each other. Preferably, the slit 522 is then closed in a fluid-tight manner. When the male connector of the fluid manipulation device is inserted, the slit 522 is opened, in particular spread open and/or expanded as described above.
The valve opening 521 of the embodiment shown in
The configuration and the size of the valve opening depends on how the connection port of the device with which a connection is intended is formed. If the connection with a conventional syringe is to be possible, the valve opening may, for example, be formed as a slit 522 as explained above.
Due to the elasticity of the material of the second seal member 52, a certain tolerance is given with regard to the dimensions of the male mating structure (male connector, i.e. the connection part) of the fluid manipulation device. This means that male mating structures of sizes that vary over a certain range can be inserted into a slit of a certain size. This is an advantage over rigid structures for making a needle-free connection with a fluid manipulation device. For example, if the second port 5 were equipped with a rigid standardised female Luer structure and not with an elastic second seal member 52, essentially only connection with a standardised male Luer cone would be possible. The second port 5 designed according to the invention allows the connection with differently shaped and sized connection structures of the fluid manipulation device. If, for example, the connection to a syringe with a standard Luer cone is primarily intended, fluid manipulation devices with different connection structures can also be connected, e.g. a syringe with a smaller or larger cone.
Preferably, the valve opening 521 is resealable, i.e. after disconnecting the fluid manipulation device, the valve opening closes 521 such that the elastic second seal member 52 ensures that the second port 5 is closed in a fluid-tight manner again. More preferably, this resealing property is retained if a fluid manipulation device is connected and disconnected again several or even many times.
Preferably, the distal portion of the second seal member 52 is thin enough so that the distal portion of the second seal member 52 can be displaced vertically with relatively low axial force while the proximal portion bends or collapses, making the connection with a fluid manipulation device user-friendly. The bent or collapsed proximal portion then acts as a spring upon removal of the fluid manipulation device pushing the distal portion back to its initial position so that the second seal member 52 again tightly closes the second port 5, i.e. is resealing.
Preferably, the second seal member 52 is elastically preloaded. This may be achieved by selecting the shape and the size of the interior space of the second port housing 51 and the shape and the size of the second seal member 52 such that at least a portion of the second seal member 52 is elastically deformed when it is accommodated in the interior of the second port housing 51. This preload may provide or improve the connection between the second seal member 52 and the second port housing 51. Additionally or alternatively, this preload may provide or improve the self-sealing property of the second seal member 52 by facilitating the return of the second seal member 52 to its original shape and position during or after removal of the fluid manipulation device and by it thereby facilitating the fluid-tight closure of the valve opening 521.
In the embodiment shown in
In addition or alternatively, in further preferred embodiments, the diameter of the second seal member 52 (measured transversely to the direction in which the fluid manipulation device is connected to the second port) is 18 mm or less, preferably 13.5 mm or less.
In addition or alternatively, in further preferred embodiments, the length of the second seal member 52 (measured in the direction in which the fluid manipulation device is connected to the second port) is between 10 and 15 mm and is longer than the cavity in which it is accommodated. This extra length creates an axial pre-load or contributes to an axial pre-load. Such axial pre-load provides a force that facilitates the return of the second seal member 52 to its original shape and position during or after removal of the fluid manipulation device and by it thereby facilitating the fluid-tight closure of the valve opening 521.
In the embodiment shown in
In specific embodiments the second seal member 52 comprises
Preferably, the distal surface of the second seal member 52 transitions essentially smoothly or entirely smoothly into the edge surface 512 of the second port housing 51.
In addition or alternatively, in further preferred embodiments, the second seal member 52 comprises an elastic material having a hardness between 25 and 55 shore A.
A peel-off foil 44 may be arranged atop of the first seal member 42. The peel-off foil 44 may be a foil comprising plastic and/or metallic materials such as an aluminium-plastic compound foil. The peel-off foil 44 may be connected to the cap 1 by welding onto the edge surface 412 of the first port housing 41.
The term “peel-off foil” indicates that preferably, the foil may be removed by the user by hand without the aid of any tools.
The peel-off foil 44 is removed before a piercing device is pierced through the first seal member 41. The peel-off foil 44 seals and protects the first seal member 42, and in particular provides tamper evidence because the peel-off foil makes it easy to determine whether the first seal member 42 is damaged or has already been punctured. Furthermore, the peel-off foil 44 provides additional tightness for the first port 4 and helps to ensure its mechanical integrity, for example, when the cap 1 is subjected to mechanical stress.
The second port 5 may have an equivalent peel-off foil 54.
The peel-off foils 44 and 54 arranged atop both seal members 42, 52 according to an embodiment of the invention are shown in
It is preferred to design the distal surface of the second port housing 51 with a chamfered edge around the second opening 511. Such chamfered edge prevents material that is potentially molten and displaced when attaching the peel-off foil 54 that could contaminate the valve opening 521 and could be detrimental to a tight connection between the second port 5 and a fluid manipulation device.
Preferably, the body 2 comprises a polyolefin and more preferably consists thereof. In particular a material selected from the group consisting of polyethylene, polypropylene and ethylene-propylene copolymers or a mixture of multiple materials selected therefrom are used as polyolefin for the body 2.
According to the embodiments shown in
In the embodiments shown in
The angle between a direction of insertion of the administration device into the first port 4 and a direction vertical to an opening formed by the container connection portion 3 is between 0 degrees and 30 degrees, preferably between 0 degrees and 10 degrees. It is particularly preferred that the orientation of the first port 4 can be substantially vertical while the administration is running because, when an IV set with a drip chamber is used, the drops shall be clearly visible so as to be identified by a user setting up the flow rate and/or by an automated drop counting device which may be used together with an administration pump to accurately deliver a medication to a patient. If the administration device deviated too much from the vertical, drops could fall rapidly to the drip chamber walls and not be detected, which may result in wrong dosage, alarm and/or emergency stop of a connected delivery pump, as well as eventually exposing the patient to a harm.
The angled arrangement of the first port 4 and the second port 5 makes it possible that an administration device or a piercing device thereof (spike) and a fluid manipulation device are simultaneously connected to the first port 4 and second port 5, respectively
The angled arrangement of the first port 4 and the second port 5 also allow for an easier disinfection of the second port when an administration device is inserted into the first port.
When the container 100 being provided with the cap 1 according to the invention is used for administering a liquid 300 to a patient, the container 100 and the cap 1 are usually oriented upside-down compared to the orientation shown in
The fastener 45 is connected to the distal portion of the first port housing 41. Together with a seat structure 413 within the first port housing 41, i.e. a step or the like at which the inner diameter of the first port housing 41 becomes narrower, the fastener provides a form-fit connection for the septum 42.
This configuration, in which the septum 42 is held by a fastener, is also referred to as “cassette design”.
Optionally, the septum 42 may have a T-shaped lateral portion, i.e. a lateral portion provided with a protrusion 424 on its proximal side that corresponds to a recess 415 on the distal side of the seat structure 413. Preferably, the protrusion 424 and the recess 415 are ring-shaped. The protrusion 424 and the recess 415 reduce the tendency of the septum 42 to be pushed further into the first port housing 41 when pierced by a piercing device. That is, the protrusion 424 and the recess 415 further hold the septum 42 in place.
The fastener 45 may be made of the same material as the body 2.
For attaching the fastener 45 to the first port housing 45, for instance welding, in particular laser welding, gluing, or another suitable technique may be applied.
In addition to the form-fit connection provided by the fastener 45 and the seat structure 413, the septum 42 may be connected to the port housing 41 by another technique such as welding, in particular laser welding, or gluing. However, the cassette design is especially favoured if the septum cannot be attached to the port housing 41 by means of welding or gluing in an easy manner. For instance, it is difficult or even impossible to weld or glue a septum 42 made of vulcanised rubber to a first port housing 41 made of, e.g., polyolefin material. For a septum 42 made of such material, the cassette design is therefore preferred. Moreover, the cassette design may provide a stronger and therefore safer connection even if the septum may in principle be held in place by welding, gluing, etc. alone.
As the fastener 45 covers the distal surface or distal portion of the first port housing 41, the distal surface of the fastener 45 is considered as the distal edge surface 412 of the first port housing 41. In this sense, the fastener 45 may be seen as part of the first port housing 41. According to the embodiment shown in
The septum 42 of the further embodiment shown in
In
In
In
The distal portion of the second seal member is configured to fit into the second opening 511 of the second port housing 51. In
The proximal portion of the second seal member 52 is formed by a protrusion that surrounds the slit 522 and is fitted with the lateral sides of the second port housing 51 but does not completely fill the second port housing 51 transversely to the slit 522. Due to the resulting cavities, the second seal member 52 is flexible enough to allow for easy insertion of the male connector.
In
The second port 5 and the second seal member 52 of the embodiments according to
The second port 5 and the second seal member 52 of the embodiments according to
Preferably, the second seal members 52 of the embodiments according to
| Number | Date | Country | Kind |
|---|---|---|---|
| 21171636.0 | Apr 2021 | EP | regional |
This application is the United States national stage entry of International Application No. PCT/EP2022/061366, filed on Apr. 28, 2022, and claims priority to European Application No. EP 21171636.0, filed on Apr. 30, 2021. The contents of International Application No. PCT/EP2022/061366 and European Application No. EP 21171636.0 are incorporated by reference herein in their entireties.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/061366 | 4/28/2022 | WO |
