Closing element for a fluid line and connector thereof, and medical system utilizing the closing element and the connector

Abstract

The present invention relates to a sealing element for a fluid line, preferably for a fluid line of a concentrate container, comprising: a sealing portion configured to be disposed on an end portion of the fluid line to fluidly seal the fluid line, wherein the sealing portion includes a predetermined break point; and a pressure receiving portion configured to receive pressure applied by a connector element, the connector element being fluidly connected to the fluid line by causing the predetermined break point to break, wherein the pressure receiving portion includes at least one protrusion extending outward from at least a portion of the sealing element, the at least one protrusion being configured to contact the connector element.

Description

[Technical Field]

[0001] The present invention relates to a sealing element for a fluid line for a concentrate container for medical purposes, a connector comprising a fluid line sealed by the sealing element, and a system comprising a concentrate container having the connector sealed by the sealing element and a connector for a blood therapy device or a drug delivery unit thereof. [Previous Technology]

[0002] In blood therapy procedures, such as dialysis, the required dialysis solution is typically produced from a dried concentrate mixed with pure water. For this purpose, a container containing a concentrate, such as bicarbonate or acid concentrate, is fluidly connected to the blood therapy device or its delivery unit to allow mixing of solutions with the desired concentrate concentration.

[0003] Before being connected to a blood therapy device or drug delivery unit, the concentrate container is sealed for storage. Conventionally, before fluidly connecting the container to the blood therapy device or drug delivery unit, the seal is manually removed from the fluid line of the concentrate container to open the fluid line and connect it to the corresponding connector element of the blood therapy device. Therefore, conventionally, due to the extensive manual handling of the concentrate container, there is a significant risk of contamination. Furthermore, the membrane conventionally used to seal the container can also be easily removed during storage, resulting in a potentially contaminated and therefore unusable container.

[0004] Another common method for sealing medical containers is to use a closure with an intended break point. These medical containers must be fluidly connected to another fluid line for delivering contents to a treatment device or patient. This closure does not need to be removed before use, but the connection is established by a portion (e.g., a point) introduced into the closure element with the intended break point. This has the disadvantage that the portion used to establish the connection first comes into contact with a potentially contaminated outer surface of the closure. [Summary of the Invention]

[0005] The objective of this invention is to mitigate or overcome the problems of the prior art.

[0006] In detail, one object of the present invention is to introduce a system that can be opened from the outside while ensuring that there is no contact between the outside and the contents of the product.

[0007] Furthermore, a safe, reliable, and hygienic component is provided for fluidly sealing the concentrate container, particularly in situations where the concentrate container is not opened directly by manual means but by a blood therapy device or its delivery unit, for example, by manually moving the connector element of the blood therapy device or its delivery unit before connection. Especially in situations where the concentrate container is manually connected to the blood therapy device or its delivery unit, it is important to ensure that only a minimal amount of force is required for the connection. This reduces the burden on personnel who must perform this connection frequently every day in routine practice.

[0008] This objective is achieved by means of the invention as described in the independent claim. Advantageous specific examples of the invention are the subject matter of the appendix claim.

[0009] One first aspect of the present invention relates to a sealing element for a fluid line, preferably a fluid line for a concentrate container, comprising: a body configured to at least partially receive the fluid line; a sealing portion configured to be disposed on an open portion of the fluid line to fluidly seal the fluid line, wherein the sealing portion includes a predetermined break point; and a pressure receiving portion configured to receive pressure applied by a pressure applying element, preferably a connector element, the connector element being fluidly connected to the fluid line by breaking the predetermined break point; wherein the pressure receiving portion includes at least one protrusion preferably extending outward from the sealing portion or the body, the at least one protrusion being configured to contact the connector element.

[0010] Preferably, the expected fracture point is a region of weakened material, such as a localized thinning of the material. The expected fracture point may have the shape of a pipeline or multiple pipelines. The closed portion may include one, two, or more than two segments, for example, having a plate shape, which are separated from each other by one or more expected fracture points.

[0011] Alternatively or additionally, the fracture point is expected to be made of a material that is more prone to fracture than material from the rest of the closure element or a portion thereof. In this case, the closure element may be made of at least two components. In its most general form, the closure element may be made of two different components that differ from each other in their mechanical properties, specifically, one component is more prone to fracture than the other. Preferably, both components are polymers.

[0012] The targeted use of polymers that are easy to fracture to selectively form closed elements in areas of intent to fracture (such as the expected fracture point) provides the following advantages: loess force is required to fracture the expected fracture point and thereby open the closed element.

[0013] For example, the sealing element may be made in part from a thermoplastic elastomer (e.g., a break point) and another polymer (e.g., linear low density polyethylene (LLDP)) forming the rest of the sealing element.

[0014] During manufacturing, for example, in a first step, a portion of the closure element is made of another polymer, such as linear low-density polyethylene (LLDP), and is initially manufactured to have a gap in the location of the portion made of a more easily fractured material (e.g., the intended fracture point made of thermoplastic elastomer). This first step produces a portion of the closure element made of one component (e.g., linear low-density polyethylene (LLDP)) with a gap located in the portion to be formed by the second component (e.g., thermoplastic elastomer).

[0015] In the second step, a second component, such as a thermoplastic elastomer, is added to the gap present in the portion of the closure element made from the first component in the first step. For example, injection molding can be used to add a thermoplastic polymer (or another second component) forming the desired breakage point to the portion of the closure element made from the first component in the first step. Alternatively or additionally, a film made of a thermoplastic polymer (or another second component) can be disposed on the surface area of ​​the closure portion to seal any gaps present, for example, between the individual plates forming the closure portion, thereby forming the desired breakage point. It is possible to dispose this film on the side of the closure portion configured to be disposed on the open portion of a fluid line to fluidly close the fluid line, and / or, in the case of the closure element being disposed on a fluid line, on the side of the closure portion opposite to the fluid line.

[0016] The fluid line may be any pipe or hose suitable for conducting fluid.

[0017] At least one protrusion of the pressure receiving portion extends outward from the closing portion, pressure receiving portion, or body of the sealing element. In other words, the protrusion extends from at least a portion of the outer surface of the closing portion, pressure receiving portion, or body of the sealing element. For example, the protrusion can be considered as a sub-segment of the pressure receiving portion that protrudes outward relative to another sub-segment of the pressure receiving portion. This applies when the protrusion extends outward from the closing portion or body of the sealing element.

[0018] For example, because the protrusion extends outward from the closed portion, pressure can be applied to the protrusion by a pressure applying element, and the pressure applying element does not need to contact the outer surface of the closed portion. Therefore, it is ensured that the closed portion never enters the flow path established after the closing element is opened and / or remains outside the flow path.

[0019] According to one specific embodiment of the present invention, the pressure receiving portion includes an annular protrusion extending at least along a portion of the outer circumference of the closing element, preferably its body, or along its entire length.

[0020] According to another specific embodiment of the invention, the closed portion comprises at least two plates that are separated from each other by a predetermined break point.

[0021] Preferably, the closed portion includes at least two plates that are connected to each other and / or separated from each other by a predetermined break point and are arranged at an angle to each other.

[0022] In an advantageous specific example, the two plates of the closed portion, which are connected and separated from each other by the expected break point and are arranged at an angle to each other, form a roof-like structure with a pointed front edge.

[0023] According to another specific embodiment of the invention, the pressure receiving portion includes a plurality of protrusions disposed along the outer circumference of the closing element, preferably disposed at the pressure receiving portion and / or the closing portion, wherein the protrusions are preferably separated from each other and / or disposed at equal intervals along the outer circumference.

[0024] In principle, it is also possible to arrange a plurality of protrusions along the outer circumference of the main body.

[0025] In an advantageous specific example, the enclosed portion is formed by a plurality of plates, each having a circular segment shape, which are arranged like flower petals around the center point of the enclosed portion.

[0026] Each of the plurality of plates is preferably separated from the adjacent plates by a predetermined fracture point (e.g., a linear structure of localized thinning of the material). In a particularly advantageous specific example, the enclosing portion comprises six plates ("petals") and more preferably, the body has a hexagonal base shape.

[0027] Preferably, each of the plurality of protrusions is disposed on a plate forming the closure portion, such that pressure applied to each protrusion is selectively transmitted to the plate on which the protrusion is disposed. A pressure-applying element presses against the plate, particularly against the radially outward section of each plate, thus tilting each plate like a lever, causing the radially outward section and the radially inward section of each plate to move in opposite directions. This tilting movement of the plate tightens the fracture point until it breaks. The anticipated fracture point can be further supported by the upper edge of the fluid line sealed by the closure element, which abuts against the plate of the closure portion from the interior of the body of the closure element. The arrangement of the plates forming the closure portion and the placement of the anticipated fracture point between each pair of adjacent plates in the closure portion reduce the force required to open the closure element.

[0028] According to another advantageous specific example, the pressure receiving portion and / or at least one of its protrusions are present on at least half of the longitudinal length of the closure element in one of the insertion directions of the fluid line to the closure element.

[0029] For example, if the protrusions extend outward from the body of the closure element in the shape of annular protrusions, the annular protrusions may be configured such that their length in the longitudinal direction of the closure element (e.g., the insertion direction of the fluid line into the closure element) is at least half the length of the closure element in that direction.

[0030] In other words, the contact surface of the pressure receiving part that contacts the pressure applying element can be provided in the distal half of the sealing element in the insertion direction from the fluid pipeline to the sealing element.

[0031] According to another specific embodiment of the invention, the groove is configured between the closure portion and the pressure receiving portion and / or at least one of its protrusions to allow the closure portion to move after it breaks at the expected fracture point.

[0032] If the pressure receiving portion and / or at least one of its protrusions are located at least half the longitudinal length of the sealing element in the insertion direction from the fluid line to the sealing element, and the sealing portion is formed by two plates arranged at an angle to each other, thus forming a roof shape, then the arrangement such as the groove is particularly helpful. After the expected fracture point is broken, the two plates of the sealing portion can move toward a straight or vertical position, and this movement is not blocked by the pressure receiving portion and / or at least one of its protrusions.

[0033] According to another specific embodiment of the invention, the pressure receiving portion includes a plurality of protrusions arranged at different positions along the longitudinal length of the closing element in the insertion direction from the fluid line to the body.

[0034] For example, the closure portion may include at least two plates of different thicknesses disposed on the body of the closure element. Due to the different thicknesses of the plates of the closure portion, protrusions disposed on the plates are positioned at different locations along the longitudinal length of the closure element in the insertion direction from the fluid line into the body.

[0035] According to another specific embodiment of the present invention, at least one protrusion of the pressure receiving portion is configured in a hook shape.

[0036] Alternatively or additionally, at least one protrusion adjacent to the pressure receiving portion forms a groove.

[0037] According to a specific embodiment of the present invention, the pressure receiving portion and / or at least one of its protrusions at least partially defines a distal face of the sealing element in the insertion direction from the fluid line to the sealing element.

[0038] This has the following advantages: the distance traveled by the pressure applying element in contact with the pressure receiving portion and / or at least one of its protrusions must be minimized before such contact is established by the relative movement of the pressure applying element and the closing element.

[0039] Alternatively, the sealing element or the connector containing the fluid line on which the sealing element is disposed may be movable relative to the pressure-applying element. In this case, the sealing element and / or connector must travel to minimize the distance to establish contact with the pressure-applying element.

[0040] According to one specific embodiment of the present invention, the body has a cylindrical or polygonal shape, especially a hexagonal shape.

[0041] It has been found that the following situation is particularly advantageous: the body has a polygonal shape and the number of plates forming the closed portion corresponds to the number of edges of the polygonal body. Specifically, the body has a hexagonal form and the closed portion contains six plates. This ensures that each plate forming the closed portion can be positioned on a straight edge of the body, thereby promoting the tilting of the plate, because the leverage effect is optimized.

[0042] According to another specific embodiment of the invention, at a connection point between the closed portion containing the expected fracture point and the body of the closed element, the material is preferably selectively weakened by providing at least one groove to promote fracture of the expected fracture point caused by pressure applied to the pressure receiving portion.

[0043] For example, the closed portion may comprise a plurality (e.g., six) plates having circular segments, arranged similarly to flower petals around a central point. These plates are preferably connected to a hexagonal body. At the connection point between the body and the plates, the material is preferably weakened, for example, by providing an annular groove extending along the outer circumference of the body.

[0044] According to another specific embodiment, the sealing element further includes a sealing structure in the form of an annular protrusion extending along the entire circumference of the body within the body. Alternatively, the sealing effect may be provided by a flush fit between the inner circumference of the sealing element body and the outer circumference of the fluid line inserted into the body.

[0045] The sealing structure can be configured to be received in a corresponding annular groove extending circumferentially outside the fluid line to removably hold the sealing element to the fluid line.

[0046] Furthermore, the sealing element may include a groove adjacent to the sealing structure, which is positioned radially outward from the sealing structure to allow radial movement of the sealing structure. This ensures easy installation of the sealing element on the fluid line.

[0047] According to one specific embodiment of the invention, the sealing element is made at least partially or entirely of a polymer material, particularly linear low-density polyethylene and / or high-density polyethylene.

[0048] The closure element is preferably manufactured by injection molding.

[0049] In one specific embodiment of the invention, the enclosed portion comprises six plates arranged in a manner resembling flower petals around a central point, each plate having a thickness between 1 mm and 3 mm. The maximum diameter of the enclosed portion is approximately 16 mm, and the main body has a diameter of approximately 10 mm.

[0050] Another aspect of the invention relates to a connector, preferably a connector for a concentrate container or other disposable item, comprising at least one fluid line providing a flow path through the connector, via which fluid can be delivered to the container to dissolve a concentrate and / or fluid can be withdrawn from the container, wherein a closure element according to the invention is disposed on at least one fluid line of the connector to preferably fluidly close the fluid line.

[0051] At least one fluid line of the connector may include only one lumen (only one tube) or may include an inner lumen and an outer lumen (a tube within a tube). The outer lumen does not provide a flow path for conducting fluid through the connector, but is preferably configured as an annular blind orifice.

[0052] If the fluid line of the connector contains only one lumen, the sealing element according to the invention is preferably disposed on this lumen / tube.

[0053] If the fluid line of the connector includes an inner cavity and an outer cavity, the sealing element is preferably disposed on the end face of the outer cavity, and the end face of the inner cavity is configured to retract into the outer cavity, such that a gap exists between the end face of the inner cavity and the sealing element. This ensures that the inner cavity does not contact the sealing element.

[0054] The outer lumen preferably extends through the connector to provide a flow path through it. Only the inner lumen is used to conduct fluid through the connector, and another lumen is used to prevent the sealing element from contacting the inner lumen.

[0055] According to another specific embodiment of the invention, the connector includes at least two fluid lines, each fluid line being fluidly closed by a sealing element according to the invention, wherein the two fluid lines have different lengths, such that a pressure applying element moving toward the connector sequentially reaches the at least two fluid lines. Therefore, the at least two fluid lines are sequentially opened by the pressure applying element.

[0056] In practice, it has been found to be advantageous that at least one of the fluid lines of the connector contains a sharp or pointed front edge that is away from the connector.

[0057] In particular, if the sealing element includes a sealing portion formed by two plates that are inclined to each other to form a roof-shaped sealing portion with a predetermined break point that connects the two plates to each other, then if a fluid line is inserted into the sealing element, the sharp or pointed front edge of the fluid line of the connector corresponds to the adjacent contour of the roof-shaped sealing portion.

[0058] Preferably, the front edge of at least one of the fluid lines of the connector includes two inclined sections configured at an angle to each other. Preferably, the inclination angles of the two inclined sections are equal.

[0059] According to a specific embodiment of the present invention, at least one of the fluid lines of the connector includes an annular groove on its outer circumference to receive a sealing structure of a sealing element, thereby securing the sealing element to the fluid line.

[0060] Another aspect of the present invention relates to a system comprising a sealing element according to the invention, a connector according to the invention, and a pressure application element, preferably a connector element of a blood therapy device or a drug delivery unit thereof, wherein the pressure application element is configured to be fluidly connected to the fluid line of the connector by causing the sealing element to break at the intended break point, preferably by the relative movement of the pressure application element and the connector.

[0061] The pressure applying element may be moved toward the connector containing the closing element, and / or the connector containing the closing element may be moved toward the pressure applying element manually or automatically.

[0062] According to a specific embodiment of the present invention, the connector, preferably a connector of a concentrate container, and / or the pressure application element, preferably a connector element of a blood therapy device or a drug delivery unit thereof, includes at least one fluid line, the at least one fluid line including an inner lumen and an outer lumen preferably concentrically arranged with each other.

[0063] Preferably, the inner cavity is configured to retract into the outer cavity. The inner cavity is used to conduct fluid, and the sealing element is disposed on the outer cavity, which does not constitute a flow path through the connector but serves to ensure that the sealing element does not contact the inner cavity. Alternatively, there may be only one tube and cavity, which is used to conduct fluid and is sealed by the sealing element.

[0064] In other words, the present invention can be described as follows:

[0065] One first aspect of the present invention relates to a sealing element for a fluid line, preferably a concentrate container, comprising: a sealing portion configured to be disposed on an end portion of the fluid line to fluidly seal the fluid line, wherein the sealing portion includes a predetermined break point, and a pressure receiving portion configured to receive pressure applied by a connector element, the connector element being fluidly connected to the fluid line by causing the predetermined break point to break, wherein the pressure receiving portion includes at least one protrusion extending outward from the sealing element, the at least one protrusion being configured to contact the connector element.

[0066] The shape and number of at least one protrusion of the pressure receiving portion can be adapted to any specific application.

[0067] If the container containing this sealing element is connected to the blood therapy device, the connector element of the blood therapy device moves in such a way that it contacts the pressure receiving portion of the sealing element and applies pressure to that pressure receiving portion. In this case, the connector element of the blood therapy device acts as a pressure applying element. For example, if the connector element of the blood therapy device is disposed on a movable flap of the blood therapy device, the connector element can move toward the connector of the container, and thus the fluid line is closed by the sealing element by linear or tilting movement.

[0068] For example, the connector element may have an external lumen that receives the closure element and is adjacent to / in contact with its pressure receiving portion. Alternatively, the connector carrying the closure element may be movable toward the connector element of the blood therapy device.

[0069] Preferably, a cap-shaped closure element is pressed downward onto the fluid line until the intended break point of the closure breaks and the fluid line is fluidly opened.

[0070] According to one aspect of the present invention, the pressure receiving portion includes at least an annular protrusion extending along a portion of the circumference outside the closing element, particularly its body or closing portion or pressure receiving portion, or along its entire length.

[0071] Alternatively or additionally, the pressure receiving portion may include a plurality of protrusions arranged along the outer circumference of the closure element, wherein the protrusions are preferably separated from each other along the outer circumference and / or arranged at equal or different intervals.

[0072] Providing separate protrusions ensures efficient force transmission from the pressure receiving portion to the intended break point, especially in cases where the enclosed portion contains several plates arranged like petals around a central point and the intended break point, for example, thinner material tubing exists between every two plates or petals.

[0073] In order to reduce the amount of space required to open the fluid line covered by the closure element via the connector element of the blood therapy device, in practice, it has proven advantageous that the pressure receiving portion and / or at least one of its protrusions are located at least half of the longitudinal length of the closure element in the insertion direction of the fluid line into the closure element. In other words, the surface for establishing contact between the closure element and the pressure applying element (or connector element) is located at the proximal half of the closure element in the direction of movement of the pressure applying element toward the closure element.

[0074] In other words, if the sealing element is disposed on the end side of the fluid pipeline as a cover, the protrusion of the pressure receiving portion is not only present at the lower end of the sealing element (away from the end face of the fluid pipeline). Instead, the protrusion extends upward at least halfway along the body of the sealing element toward the upper end of the sealing element (covering the end face of the fluid pipeline) in the longitudinal direction of the sealing element (the insertion direction of the fluid pipeline). This is particularly advantageous when the sealing portion comprises two plates that are arranged at an angle to each other to form a roof shape and are connected to each other via a central intended break point.

[0075] This has the following advantages: if the connector element of the blood therapy device moves downward onto the sealing element to contact the pressure receiving portion and presses the sealing element downward onto the fluid line until the expected break point opens, the connector element of the blood therapy device must move a shorter distance before its adjacent pressure receiving portion. Therefore, the components used to fluidly couple the concentrate container to the blood therapy device or drug delivery unit require less space, thereby allowing for a more compact design of the drug delivery unit.

[0076] To minimize the distance that the connector element of the blood therapy device must travel to establish contact with the pressure receiving portion, the pressure receiving portion and / or at least one protrusion thereof may be configured to define the distal face of the sealing element in the insertion direction from the fluid line to the sealing element. In other words, when the sealing element is configured on the fluid line to fluidly seal that fluid line, the plane of the upper end face of the sealing element or cover may be at least partially defined by the pressure receiving portion.

[0077] In practice, it has further proven advantageous that the pressure receiving portion includes a plurality of protrusions disposed at different positions along the longitudinal length of the closure element in the insertion direction from the fluid line into the closure element. In this case, as the connector element of the blood therapy device moves downward onto the closure element, the protrusions disposed at different longitudinal positions sequentially open (starting from the top protrusion) as the connector element moves from the upper end of the closure element to the lower end of the closure element. For example, in the case where the closure portion includes several plates arranged like flower petals and separated from each other by an intended break point, one or more plates may have different thicknesses, such that the pressure applying element sequentially abuts plates of different thicknesses. The thickness of the plates may vary depending on the specific application; for example, only one of the plates in the closure portion may have a thickness different from the thickness of the other plates, which have a uniform thickness. Alternatively, the thickness of two or more plates may be different from the thickness of the remaining plates. Therefore, the flow diameter of the opening of the concentrate container can be progressively increased, and the maximum force required to open the closure element can be reduced.

[0078] According to an advantageous embodiment of the invention, the sealing element comprises a cylindrical or hexagonal body for receiving the end portion of the fluid line. Other geometries of the body, such as a heptagonal, triangular, or square base region, are possible, preferably as long as the sealing element can still be disposed on the fluid line to be sealed in a cap-like manner.

[0079] If the hexagonal body is used in conjunction with a closed portion comprising six plates, each of the six plates of the closed portion has the advantage of being positioned on a straight edge of the hexagonal body. This facilitates opening the closing element after pressure is applied to the pressure receiving portion due to the tilting movement of the plates of the closed portion supported by the straight edge. The plates of the closed portion act as levers for breaking at the expected break point. The expected break point acts as a lever optimized by the configuration of the straight lines positioned between the plates.

[0080] A closure element preferably having the form of a cover may include: a body configured to receive a fluid line to be closed; and a closure portion configured to fluidly close the fluid line.

[0081] In order to facilitate the breaking of the intended break point by means of the connector element and thus ensure easy and reliable opening of the container, the material may preferably be selectively weakened by providing at least one groove at at least one connection point between the closed portion containing the intended break point and the body of the closed element.

[0082] In this specific example, preferably, the closing portion and the pressure receiving portion are integrally formed, such that after pressure is applied to the pressure receiving portion, the closing portion or at least a portion thereof moves by tilting motion to cause the expected fracture point to break.

[0083] The weakening of the material at at least one connection point between the closed portion and / or pressure receiving portion containing the expected fracture point and the body of the closing element allows the closed portion and / or pressure receiving portion to tilt easily and thus cause the expected fracture point to break. This is particularly relevant when the closed portion contains multiple plates arranged around a central point in a manner similar to flower petals, wherein these plates are separated from each other by conduits of the weakened material forming the expected fracture point.

[0084] In order to improve the storage capacity of the container sealed by the sealing element according to the invention, the sealing element may further include a sealing structure on the inner circumference of the body, which is preferably in the form of an annular protrusion extending along the entire circumference of the body, to ensure the airtightness of the container.

[0085] Preferably, the closure element is at least partially or entirely made of a polymer material, particularly linear low-density polyethylene and / or high-density polyethylene. These materials offer an optimal trade-off between mechanical stability and stiffness at the expected fracture point, thus ensuring reliable fracture, and flexibility, thereby ensuring that the effort required to fracture the closure element remains reasonable. An elastomer is also possible, either alone or in combination with linear low-density polyethylene and / or high-density polyethylene.

[0086] Another aspect of the present invention relates to a connector, preferably a connector for a concentrate container or other disposable item, wherein a closure element according to the present invention is fixedly or removably disposed on at least one fluid line of the connector to preferably fluidly close the fluid line.

[0087] The fluid line preferably provides a flow path through the connector and can be used, for example, to transfer fluid to or from a concentrate container. The fluid line can be any tube or hose.

[0088] The connector of a disposable product may include at least one retaining element, which is, for example, in the shape of a hook, and the retaining element is configured to retain the connector in the vicinity of the connector element of the blood therapy device or its drug delivery unit, wherein the connector of the disposable product shall be connected.

[0089] The connector for disposable items may also include a structure for opening a valve of the connector element of the blood therapy machine or its drug delivery unit after the connector for disposable items is connected to the connector element of the blood therapy machine or its drug delivery unit. For example, the fluid line of the connector for disposable items may include a central rod or tip configured to remove a valve element from its seat in the valve of the blood therapy machine or its drug delivery unit, thereby allowing fluid to flow through the valve. The shape of the rod or tip is arbitrary, and any structure suitable for opening the valve after the connector is connected to the connector element may be selected.

[0090] Preferably, the fluid conduit of the connector includes an inner cavity or inner tube and an outer cavity or outer tube, wherein the sealing element is disposed on the end face of the outer cavity, and the end face of the inner cavity is configured to retract into the outer cavity, such that a gap exists between the end face of the inner cavity and the sealing element. In other words, the outer tube is used to protect or safeguard the inner cavity from contact with the sealing element. This provides the advantage of minimizing contamination of the inner tube used for fluid conduction.

[0091] According to an advantageous specific example, the connector includes at least two fluid lines, each fluid line being fluidly closed by a sealing element according to the invention, wherein the two fluid lines extend from the end face of the connector by different lengths.

[0092] If the concentrate container containing this connector will be connected to the blood therapy device or administration unit, then the two fluid lines are opened and connected to the blood therapy device or administration unit in sequence, this is because, first, the fluid line extending further from the self-connector towards the blood therapy device or administration unit is opened and, secondly, the shorter fluid line is opened and connected.

[0093] Yet another state of the present invention relates to a system comprising a confining element according to one of the present invention, a connector according to one of the present invention (preferably a connector of a concentrate container) and at least one connector element, preferably a connector element of a blood therapy device or one of the administration units thereof, wherein the connector element is configured to resort to a disconnection of the confining element in which the connection of the confining element is broken to at least one intended break of the fluid line thereof.

[0094] In this system, the following situation is confirmed to be advantageous: The connector, preferably a connector element of a blood therapy device or a administration unit thereof, comprises an internal and external lumen that are better configured concentrically with each other. In each case, an internal lumen or tube and an external lumen or tube may form a fluid line.

[0095] The connector element of the blood therapy machine or its administration unit may be moved and / or moved towards the connector and the fluid line of the disposable item by translational or linear movement or by rotational movement towards the connector and the fluid line thereof, this is because, for example, the connector element is configured in a trap plate of the blood therapy device that is tilted to make contact with the connector of the disposable item.

[0096] The following situation is confirmed to be advantageous: the connector element of the blood therapy machine is configured to be moved with respect to the main body of the blood therapy device such that it can optionally be moved to establish a connection to the disposable item.

[0097] For example, the connector element of a blood therapy device or administration unit may comprise: a portion that can be moved with respect to the body of the device, which is used to establish a fluid connection between the disposable item and the blood therapy device;

[0098] Preferably, a portion of the fluid line containing the blood therapy device may be moved and / or further configured upward on the main body of the blood therapy device with the blood therapy device placed on a horizontal plane in its normal operating position. The movable portion containing the fluid line may be moved towards the connector by means of translational or rotational movement.

Implementation Method

[0100] As shown in FIG. 1, according to a first specific embodiment of the present invention, a sealing element 1 is disposed as a cap on the end of a fluid line 1, which is preferably part of a connector for a container for a concentrate. The sealing element 1 has a sealing portion 3 that fluidly seals the fluid line, particularly its outer tube 2, a cylindrical body 4, and a pressure receiving portion 5, which in this specific embodiment is configured as an annular protrusion extending along the outer circumference of the body 4 at the lower end of the sealing element 1.

[0101] On the inner circumference of the main body 4, the sealing element 1 includes an annular sealing protrusion 6 that seals the gap between the inner circumference of the main body 4 and the outer tube of the fluid pipeline 2. The fluid pipeline also includes an inner tube 7, which is concentrically arranged with the outer tube and terminates before the end face defined by the outer tube 2, such that the inner tube 7 is configured to retract into the cavity of the outer tube 2, thereby ensuring that the gap or distance D is between the end face of the inner tube 7 and the sealing element 1.

[0102] The fluid line has an outer lumen L1 and an inner lumen L2. The inner lumen L2 is used to conduct fluid. The inner circumference of the inner lumen L2 includes an annular sealing protrusion 8. The outer lumen L1 is not used to conduct fluid, but is used to ensure the distance between the sterile inner lumen L2 and the sealing element 1. The outer lumen can be considered as an annular blind hole that does not pass through the connector 12.

[0103] Figure 2 shows a cross-section of the fluid line closed by the sealing element 1 shown in Figure 1, wherein the intended break point of the sealing element 1 is caused by the connector element 9 moving downwards onto the fluid line of the concentrate bag. In principle, it is also possible to move the connector of the concentrate bag upwards toward the connector element 9, thereby causing the sealing element 1 to break.

[0104] Connector element 9 is part of a blood therapy device or its drug delivery unit and includes an outer tube 10 configured to press against a pressure receiving portion 5 of a sealing element 1 to open the sealing element 1 at the intended break point as indicated by the arrow in Figure 2. Connector element 9 further includes an inner tube 11 configured to insert into the inner tube 7 of the connector to establish a fluid connection between the concentrate container and the blood therapy device. Through this fluid connection, fluid can be pumped into or withdrawn from the concentrate container.

[0105] FIG3a shows a connector 12 of the concentrate bag according to the present invention. The connector 12 is integrally made of polymer material. The connector 12 includes two attachment elements 21 for attaching the connector 12 to a blood therapy device. In this specific example, the attachment elements 21 have a hook shape, which is configured to insert into a corresponding groove (e.g., a flushing groove) of the connector element of the blood therapy device.

[0106] Typically, the connector element of a blood therapy device comprises two parts: a first part includes at least one fluid line for establishing a fluid connection with, for example, a concentrate container. The second part includes at least one recess, typically two recesses, configured to receive at least one fluid line from the first part to short-circuit the fluid line during flushing. In the present case, the attachment element 21 or hook of connector 12 is configured to insert into these flushing recesses to secure the connector, and thus the concentrate container, to the blood therapy device. Connector 12 includes a handle 23 for moving the concentrate bag to attach to the connector.

[0107] After connector 12 has been secured to the blood therapy device, the connector element of the blood therapy device, particularly the first portion of its fluid-carrying conduit, moves relative to connector 12 to press against the closing element 1 disposed on the open end of tube 7 of connector 12, thereby providing a flow path through the connector and into the concentrate container. The connector element of the blood therapy device applies pressure to the closing element 1 until it breaks at its intended break point and opens the closing element 1. The outer tube 2 is not used to conduct fluid but ensures proper assembly of the attachment element 21 in the flushing recess of the blood therapy device.

[0108] FIG3b illustrates different specific examples of the connector 12 according to the present invention. In this specific example, the attachment element 21 has a different shape and is configured as a curved arm extending from the body of the connector 12. These arms define a U-shaped groove 22, which is configured to receive a corresponding attachment element of a blood therapy device, which may be, for example, strip-shaped or rod-shaped.

[0109] As can be seen in Figure 3b, connector 12 includes two fluid lines, each of which is closed by a sealing element 1.

[0110] Figure 4 shows a connector 12 for a concentrate bag according to another specific embodiment of the present invention. The connector includes two fluid lines, each having only one tube 7 for conducting fluid. Each fluid line is closed by a sealing element 1 according to a second specific embodiment of the present invention. The tube 7 includes a lumen for conducting fluid.

[0111] The connector 12 shown in Figure 4 includes two attachment elements 21, each disposed on one of the tubes 7. Each attachment element 21 includes two parallel protrusions extending radially outward from the outer circumference of each tube 7 and disposed at different positions along the longitudinal axis of each tube 7. The attachment elements 21 are configured to receive corresponding attachment elements of a blood therapy device, which may be, for example, strip-shaped or rod-shaped.

[0112] As shown in Figure 5, the end face of the tube 7 of each fluid line of connector 12 is inclined in two directions. This ensures that greater pressure can be applied locally at the tip of tube 7 compared to the case of using a horizontal end face. It is also possible to make the end face inclined in only one direction or to have a horizontal end face. However, providing end faces that are inclined in two directions and configured at an angle to each other has the following advantageous effects: the distance that the pressure application element (e.g., connector element of a blood therapy device) or connector needs to travel can be reduced, thus allowing for a more compact design of the pressure application element, especially the connector element of a blood therapy device. The geometry of the end face is variable and can be adapted to any application. Figure 6 shows a side view of connector 12 of Figures 4 and 5.

[0113] As shown in Figure 7, one or two or more or all fluid lines of connector 12 may be equipped with a center rod, which is configured to open the valve by removing the valve element from the corresponding valve seat after connector 12 is connected thereto, thereby allowing fluid to flow through the valve.

[0114] Figure 8 shows a perspective view of the closure element 1 according to a second specific embodiment. In this embodiment, the pressure receiving portion 5 is not only present at the lower end of the closure element 1 as shown in Figure 1, but also extends upward from the lower end face 14 of the closure element to the upper end face 15. In this embodiment, the pressure receiving portion 5 defines the plane of the upper end face 15. This embodiment provides the advantage that the connector 9 only needs to move a short distance before its outer tube 10 abuts the pressure receiving portion 5, and pressure can be applied to open the closure element 1.

[0115] Figure 9 shows a top view of the sealing element 1 of Figure 8. In this view, the intended fracture point 3a of the sealing portion 3 is clearly visible. The sealing portion is formed by two sloping surfaces that lean against each other in a roof-like manner. The cylindrical body 4 of the sealing element is visible between the sealing portion 3 and the pressure receiving portion 5.

[0116] Figure 10 shows a cross-sectional view of the sealing element in Figure 8. The cylindrical body 4 of the sealing element is visible between the sealing portion 3 and the pressure receiving portion 5, and the expected fracture point 3a can be easily seen.

[0117] The outline of the closed part 3 is roof-shaped and follows the outline of the front edge of the tube 7 of the connector 12.

[0118] FIG. 11 shows a cross-sectional view of the sealing element 1 of FIG. 8 on the tube 7 of the fluid line disposed on the connector 12. The sealing structure 6 existing on the inner circumference of the body 4 of the sealing element 1 is received in a corresponding annular groove on the outer circumference of the tube 7 to removably lock the sealing element 1 to the tube 7 via a form-fitting mechanism.

[0119] A groove 24 exists between the closed portion 3 and the pressure receiving portion 5. This groove 24 allows the two angular plates of the closed portion 3 to move toward a straight position after the expected fracture point 3a is fractured.

[0120] Another groove 25 exists in a radially outward position of the self-sealing structure 6 to allow the sealing structure 6 to move flexibly after, for example, a fluid line of pipe 7 is inserted into the sealing element 1.

[0121] Figure 12 illustrates the first step in the connection process of the connector 12 and the closure element 1 of Figure 11 to the connector element 9 of the blood therapy device. In this step, the connector element 9 and the tube 7 are aligned and brought close to each other. The connector 12 is attached to the connector element of the blood therapy device via the attachment element 21, which includes the protrusion 21a.

[0122] Figure 13 shows the second step in the connection process of connector 12 and closure element 1 of Figure 11 to connector element 9 of blood therapy device. In this stage, connector 9 has moved downward toward connector 12 until the outer tube 10 of connector 9 presses against the pressure receiving portion 5 of closure element 1, and closure element 1 moves downward along the longitudinal direction of tube 7 until the closure element is opened as shown in Figure 13.

[0123] As shown in Figure 14, in the third step, the connector element 9 moves further downward until the center rod 13 of the tube 7 enters the inner cavity of the connector inner tube 11, and then removes the valve element 16 from its valve seat so that the fluid can flow through the cavity of the inner tube 11 into the concentrate container.

[0124] Figure 15 shows a perspective view of the closure element 1 according to a third specific embodiment. The closure element includes a body 4, and in this specific embodiment, includes six elements or plates movably joined to the body 4, which together form a closing portion 3 and a pressure receiving portion 5 of the closure element. These elements are arranged in a petal-like manner. Each plate has a circular cross-sectional shape. The outer edges of each plate are arranged in a rectangular shape in the radial direction.

[0125] At their outer edges, each of these petals is provided with a protrusion 5a, which is part of the pressure receiving portion 5 and can be configured as a hook to hold the outer tube 10 of a connector element 9, such as a blood therapy device. Each plate or petal, especially its pressure receiving portion, extends outwardly from the body 4 of the closure element 1, so that each plate is easily tilted after pressure is applied to it. These plates thus act as levers.

[0126] The elements forming the flower-shaped petals are separated from each other by the expected fracture point 3a. Combining the design of the expected fracture point and the shape of the plate, providing individual protrusions has the following advantageous effect: the force and strain acting on the expected fracture point after pressure is applied to the plate are optimized.

[0127] Figure 16 shows a cross-sectional view of the closed element in Figure 15.

[0128] Figure 17 shows the first step in the connection process of the tube 7, which is closed by the sealing element 1 of Figure 15, to the connector element 9 of the blood therapy device. At the stage shown in Figure 17, the connector element 9 and the tube 7 containing the sealing element 1 are aligned with each other.

[0129] At the stage shown in Figure 18, the connector element 9 has moved toward the closing element 1, such that the front edge of the outer tube 10 is adjacent to the pressure receiving portion 5 of the closing element 1.

[0130] In the stage shown in Figure 19, the connector element 9 has moved further onto the tube 7 and pressed against the pressure receiving portion 5 of the sealing element 1, such that the sealing portion 3 of the sealing element, and therefore its expected break point 3a, is tightened due to the tilting or rotational movement of the element forming the sealing portion 3 ("petal"). The edge of the tube 7 presses against the element forming the sealing portion from the inside of the sealing element 1 to facilitate opening the sealing element.

[0131] At the stage shown in FIG20, the connector element 9 has now moved onto the tube 7 such that the pressure applied to the pressure receiving portion 5 of the sealing element 1 exceeds the force required to break at the expected break point 3a in FIG20. As shown in FIG20, the element ("petal") forming the sealing portion 3 tilts or rotates, thereby opening the sealing element 1.

[0132] Therefore, in this specific example, the closing element 1 is opened by tilting or rotating the closing part, which acts as a lever.

[0133] Figure 21 shows a cross-sectional view of the closing element 1 according to another specific example. In this specific example, the material at the connection point 17 between the element ("petal") forming the closing part 3 and the pressure receiving part 5 and the body 4 of the closing element 1 has been selectively weakened to ensure that the element ("petal") forming the closing part 3 and the pressure receiving part 5 is easy to tilt / rotate after pressure is applied.

[0134] The weakening of the material preferably involves removing up to 50% of the material, more preferably up to 30% or up to 20% of the material. Depending on the material, removing up to 80% of the material is possible.

[0135] Figure 22 illustrates the sequential opening of two fluid lines (in this case, their inner tubes 7), each of which is closed by a sealing element 1 according to the invention. The inner tube 7, positioned on the left side in Figure 22, extends further from the connector 12 and is therefore closer to the connector element 9 of the blood therapy device. As the connector element 9 of the blood therapy device moves toward the connector 12, the connector element 9 first reaches the left-side tube 2, and therefore that tube is opened first.

[0136] Figure 23 shows a cross-sectional view of the closure element 1 according to another specific example. In this specific example, the body 4 of the closure element 1 has a hexagonal shape. The closure portion 3 and the pressure receiving portion 5 are formed by six elements arranged in a manner similar to flower petals.

[0137] In this specific example, each protrusion 5a of the pressure receiving portion 5 of each petal is formed by a groove or recess 5b. The protrusion 5a extends relative to the surface defined by the groove 5a.

[0138] As illustrated in Figure 23, the protrusion 5a of the pressure receiving portion 5 and / or the elements forming the closed portion 3 and / or the pressure receiving portion 5 can be arranged at different positions along the longitudinal direction of the closed element 1.

[0139] For example, in Figure 23, the element positioned at the top in the longitudinal direction is indicated by reference numeral 18. The element positioned second to top in the longitudinal direction of the four elements is indicated by reference numeral 19. The element indicated by reference numeral 20 is positioned at the lowest point in the longitudinal direction of the closing element 1. Therefore, element 18 has a greater thickness than element 19, and element 20 has the smallest thickness. All elements 18, 19, and 20 forming the closing portion 3 are attached to the hexagonal body 4 in the same longitudinal position—for example, on the common continuous edge of the hexagonal body. In this specific example, these elements are plates.

[0140] Therefore, if the connector element 9 of the blood therapy device moves from the top in Figure 23 to the sealing element 1, the leading edge of the outer tube 10 of the connector element 9 first collides with the topmost element 18, then with the middle element 19, and finally with the lowest element 20. Thus, the flow cross-section of the sealing element gradually increases in sequence. Furthermore, the force required to open the sealing element can also be reduced.

[0141] FIG24a shows a machine connector 30 of a blood therapy device 26, which includes a first portion 27 and a second portion 29 that are rotatable about a hinge 28. In the state shown in FIG24a, the connector element 26 is closed such that the first portion 27 is adjacent to the second portion 29, which is fixed immovably to the blood therapy device 26.

[0142] The first part 27 includes two connector elements 9 in the shape of fluid lines, which are used to fluidly connect the blood treatment device 26 to, for example, a concentrate container. The connector elements 9 may have the configuration shown in Figures 1, 2, and 17 to 20. The first part 27 may have the shape of a cover or flap that can be moved via a hinge 28. The movement of the first part 27 may be achieved manually or automatically via a motor. The movement of the first part 27 opens the closure element 1 present on the connector 12 and establishes a fluid connection between the blood treatment device 26 and the connector 12.

[0143] Figure 24b shows the machine connector 30 of Figure 24a in the open state. Connector 12 is secured to the second part 29. The second part 29 includes two recesses (not visible in Figure 24b) into which the two attachment elements 21 of connector 12 are inserted. The first part 27 includes two connector elements 9, i.e., fluid lines, each of which can be inserted into the recess of the second part 29 for rinsing or for establishing a fluid connection with the concentrate container via connector 12.

[0144] The connector element 9 / fluid line of the first portion of the machine connector 30 of the blood therapy device 26 preferably each includes an inner tube 11 and an outer tube 10 and thus has two lumens. The inner tube 11 is used to conduct fluid and is configured to retract within the outer tube 10. The outer tube 10 is used, for example, to apply pressure to the closure element 1. After the closure element 1 has been opened by the outer tube 10, the inner tube 11 is inserted into the fluid line (e.g., tube 7) of the connector 12 to fluidly connect the blood therapy device 26 and the connector 12 to the concentrate container attached thereto. Therefore, the sterile inner tube 11 never comes into contact with the non-sterile closure element 1.

[0145] A valve containing a valve element 16 may be disposed within the lumen of the inner tube 11. The fluid line of the connector 12—for example, tube 7—contains a member 13, such as a center rod, for opening the valve by displacing the valve element 16. Thus, the valve is opened only after the connector 12 is connected to the machine connector 30 of the blood therapy device. Therefore, leakage of fluid from the connector element 9 or the fluid line is prevented.

[0146] In order to connect the blood treatment device to the concentrate container, the first part 27 of the machine connector 30 moves downward toward the connector 12 until the fluid line / connector element 9 is inserted into the connector and the closure element present on the fluid line / tube of the connector 12 is opened.

[0147] Connector 12 is secured to second part 29. Second part 29 includes an attachment member to which connector 12 can be secured via its attachment member 21. The attachment member of second part 29 may be, for example, a recess (such as recess 31) or a protrusion (such as protrusion 32). Such attachment members are preferably fixedly and immovably connected to blood therapy device 26.

[0148] Between treatment phases, the connector element 9 of the blood therapy device 26 needs to be rinsed or sterilized. For this purpose, the connector element 9 of the first part 27 is inserted into the groove 31 of the second part 29 until the lumen of the outer tube 10 is fluidly sealed. The inner tube 11 is configured to retract into the lumen of the outer tube 10, and thus can be rinsed in this position because the connector element 9 is fluidly short-circuited.

[0149] In this configuration, the flushing flow system is supplied via the lumen of the inner pipe 11 and removed to the drain pipe via the lumen of the outer pipe 10. Each flushing recess 31 may be equipped with a structure for actuating a valve to allow flushing fluid flow. Such valve actuators may have the shape of a central rod 34 (see Figure 26). In addition, the flushing recess 31 may also be equipped with a drain pipe to remove any remaining flushing fluid.

[0150] Figure 25 shows the different machine connectors 30 of the blood therapy device 26, the first portion 27 of which is translatably movable. In Figure 25, a flushing groove 31 in the second portion 29 of the machine connector 30 can be seen. The connector 12 can be secured to the second portion 29 by inserting the attachment element 21 into the flushing groove 31, and the first portion 27, including the connector element 9, then moves downward to establish a fluid connection between the blood therapy device and the concentrate container by means of the connector 12.

[0151] Figure 26 shows a connector 12 for a concentrate container, which is attached to a blood therapy device 26 via its attachment element 21. A second portion 29 of the machine connector of the blood therapy device 26 includes a movable drawer 33 containing a rinsing recess 31. It is also possible to position the rinsing recess 31 in a fixed position relative to the blood therapy device 26. The movable drawer 33 further includes a rod-shaped attachment element 32.

[0152] The connector 12 includes an attachment element 21 having a curved arm shape, which is configured to receive a corresponding rod-shaped attachment element 32 of the blood therapy device. In the specific example shown in FIG26, the connector is therefore secured to the blood therapy device not via the flushing groove 31, but via separate attachment elements 32 and 21 that interact with each other.

[0153] After the connector 12 is connected to the movable drawer 33 of the second part 29, the movable drawer 33 then moves toward the blood therapy device 26. [Simplified Explanation of the Diagram]

[0099] Other features, effects, and advantages of the present invention will become apparent from the following detailed description of specific examples of the invention with reference to the accompanying drawings. Identical or similar components are indicated by the same reference numerals.In the figures: [Figure 1] shows a cross-section of a fluid line closed by a sealing element according to a first embodiment of the invention; [Figure 2] shows a cross-section of a fluid line closed by a sealing element according to a first embodiment of the invention as shown in Figure 1, wherein the intended break point of the sealing element is broken; [Figure 3a] shows a connector for a concentrate bag according to the invention; [Figure 3b] shows another connector for a concentrate bag according to the invention; [Figure 4] shows a connector for a concentrate bag according to the invention, comprising two fluid lines each closed by a sealing element according to a second embodiment of the invention; [Figure 5] shows a perspective view of the connector of Figure 4; [Figure 6] shows a side view of the connector of Figure 4; [Figure 7] shows a cross-sectional view of the connector of Figure 4; [Figure 8] shows a perspective view of a sealing element according to the second embodiment; [Figure 9] shows a top view of the sealing element of Figure 8; [Figure 10] shows a cross-sectional view of the sealing element of Figure 8; [Figure 11] shows a cross-sectional view of the sealing element of Figure 8 disposed on the fluid line of the connector of Figure 4; [Figure 12] shows the first step in the connection process of the connector and closure element of Figure 11 to the connector element of the blood therapy device; [Figure 13] shows the second step in the connection process of the connector and closure element of Figure 11 to the connector element of the blood therapy device; [Figure 14] shows the third step in the connection process of the connector and closure element of Figure 11 to the connector element of the blood therapy device; [Figure 15] shows a perspective view of the closure element according to a third specific example; [Figure 16] shows a cross-sectional view of the closure element of Figure 15; [Figure 17] shows the first step in the connection process of the connector and closure element of Figure 15 to the connector element of the blood therapy device; [Figure 18] shows the second step in the connection process of the connector and closure element of Figure 15 to the connector element of the blood therapy device; [Figure 19] shows the third step in the connection process of the connector and closure element of Figure 15 to the connector element of the blood therapy device; [Figure 20] shows the fourth step in the connection process of the connector and closure element of Figure 15 to the connector element of the blood therapy device; [Figure 21] shows a cross-sectional view of the closure element according to another specific example; [Fig. 22] illustrates the sequential opening of two fluid lines, each closed by a sealing element according to the present invention; [Fig. 23] shows a cross-sectional view of a sealing element according to yet another specific example; [Fig. 24a] shows a machine connector of a blood therapy machine that can be rotated in the closed state; [Fig. 24b] shows the machine connector of Fig. 24a in the open state; [Fig. 25] shows different machine connectors of a blood therapy machine that can be translated; [Fig. 26] shows a connector for a concentrate container attached to a blood therapy device.

Claims

1. A closure element for a fluid line, preferably for a fluid line of a concentrate container, comprising: a body configured to at least partially receive the fluid line; a closure portion configured to be disposed on an open portion of the fluid line to fluidly close the fluid line, wherein the closure portion includes a predetermined break point; and a pressure receiving portion configured to receive pressure applied by a pressure applying element, preferably a connector element, to fluidly connect to the fluid line by causing the predetermined break point to break, wherein the pressure receiving portion includes at least one protrusion, preferably extending outward from the closure portion or the body, the at least one protrusion configured to contact the connector element; wherein the closure portion includes at least two plates separated from each other by the predetermined break point.

2. The sealing element for a fluid pipeline as claimed in claim 1, wherein the pressure receiving portion includes an annular protrusion extending along the entire length of the sealing element, preferably its body.

3. A sealing element for a fluid pipeline as claimed in claim 1 or 2, wherein the sealing portion comprises at least two plates separated from each other by the intended break point and arranged at an angle to each other.

4. A sealing element for a fluid pipeline as claimed in claim 1 or 2, wherein the pressure receiving portion includes a plurality of protrusions disposed along the outer circumference of the sealing element, preferably disposed at the pressure receiving portion, wherein the protrusions are preferably separated from each other and / or disposed at equal intervals along the outer circumference.

5. The sealing element for a fluid pipeline as claimed in claim 4, wherein each of the plurality of protrusions is disposed on a plate forming the sealing portion, such that pressure applied to each protrusion is selectively transmitted to the plate on which the protrusion is disposed.

6. The sealing element for a fluid line as claimed in claim 5, wherein the pressure receiving portion and / or at least one protrusion thereof are present on at least half of the longitudinal length of the sealing element in one of the insertion directions of the fluid line to the sealing element.

7. The sealing element for a fluid line as claimed in claim 6, wherein the pressure receiving portion and / or at least one of its protrusions at least partially defines a distal face of the sealing element in the insertion direction from the fluid line to the sealing element.

8. The closure element for a fluid pipeline as claimed in claim 5, wherein the body has a cylindrical or polygonal form, particularly a hexagonal form.

9. The sealing element for a fluid pipeline as claimed in claim 5, wherein at a connection point between the sealing portion containing the expected fracture point and the body of the sealing element, the material is selectively weakened, preferably by providing at least one groove, to facilitate fracture of the expected fracture point due to pressure applied to the pressure receiving portion.

10. A sealing element for a fluid pipeline as claimed in claim 1 or 2, wherein the sealing element is made at least partially or entirely of a polymeric material, particularly linear low-density polyethylene and / or high-density polyethylene.

11. The sealing element for a fluid pipeline as claimed in claim 10, wherein the sealing element is formed of at least two polymers, one of which is preferably more brittle than the other, and the more brittle polymer preferably forms the intended fracture point.

12. A connector, preferably a connector for a concentrate container or other disposable product, comprising at least one fluid line providing a flow path through the connector, wherein a closure element as claimed in any one of claims 1 to 11 is disposed on at least one fluid line of the connector to preferably fluidly close the fluid line.

13. The connector of claim 12, wherein the fluid line comprises a single lumen or comprises an inner lumen and an outer lumen, wherein the closure element is disposed on one end face of the single lumen or the outer lumen, and one end face of the inner lumen is configured to retract into the outer lumen such that a gap exists between the end face of the inner lumen and the closure element.

14. A connector as claimed in any of claims 12 to 13, wherein at least one of the fluid lines of the connector includes a sharp or pointed front edge away from the connector.

15. A medical system comprising: a closure element as claimed in any one of claims 1 to 11; a connector as claimed in any one of claims 12 to 14; and a pressure application element, preferably a connector element of a blood therapy device or a drug delivery unit thereof, wherein the pressure application element is configured to be fluidly connected to the fluid line of the connector by causing the closure element to break at the intended break point, preferably by relative movement of the pressure application element and the connector.

16. The medical system of claim 15, wherein the connector, preferably a connector for a concentrate container and / or the pressure application element, preferably a connector element for a blood therapy device or a drug delivery unit thereof, includes at least one fluid line, the at least one fluid line including an inner lumen and an outer lumen preferably concentrically arranged with respect to each other.

Images