Closure for a hollow medical body, hollow medical body having such a closure and method for manufacturing such a closure - Patents.com

Abstract

Closure for a hollow medical body, a hollow medical body having such a closure and a method for manufacturing such a closure.The present invention relates to a closure (1) for a hollow medical body (3), comprising an engagement element (9) configured to engage in at least a partial area with a distal opening (13) of the hollow medical body (3) when the closure (1) is placed on the hollow medical body (3) in a closed position, the engagement element (9) having at least one first groove (15.1), a groove direction (16) assigned to the at least one first groove (15.1) being aligned along an axial direction (19) of the hollow medical body (3) when the closure (1) is placed on the hollow medical body (3) in a closed position.

Description

[Technical field]

[0001] The present invention relates to a closure for a hollow medical body, to a hollow medical body provided with such a closure, and to a method for manufacturing such a closure. [Background technology]

[0002] It is known that in hollow medical bodies pre-filled with a product, in particular in pre-filled disposable syringes, a pressure difference forms between the interior of the hollow medical body and the exterior of the hollow medical body, in particular an overpressure forms inside the hollow medical body. This pressure difference, in particular this overpressure, can form due to changes in air pressure during the manufacturing process, in particular when the stopper and / or the plunger rod are placed, and / or during transportation and / or storage of the filled hollow medical body.

[0003] Known closures for pre-filled hollow medical bodies have at least one sealing element configured to seal and cover the distal opening of the hollow medical body, particularly when the closure is placed on the hollow medical body in the closed position.

[0004] When a hollow medical body is opened, particularly when a closure is removed, excess pressure within the hollow medical body, particularly a filled hollow medical body, and the resulting immediate equalization of pressure can cause product to form droplets at the distal opening of the hollow medical body.

[0005] The drawback of this is that when the hollow medical body is opened, the liquid droplets may bulge out of the hollow medical body, reducing the amount of product that can be administered to the patient. Furthermore, the liquid droplets may wet the threads and / or cones of the hollow medical body, which may adversely affect, and in particular reduce, the adhesion between the threads or cones and the device for applying the product of the hollow medical body. Summary of the Invention

[0006] The present invention is therefore based on the task of creating a closure for a hollow medical body, a hollow medical body with such a closure and a method for manufacturing such a closure, whereby the aforementioned disadvantages are at least partially eliminated and preferably avoided.

[0007] This problem is solved by providing the present technical teachings, in particular the teachings of the independent claims and the embodiments disclosed in the dependent claims and the specification.

[0008] This problem is solved in particular by providing a closure for a hollow medical body, the closure having an engagement element configured (in particular with an engagement protrusion configured in a conical shape) to engage in at least a partial area with a distal opening of the hollow medical body when the closure is placed on the hollow medical body in the closed position. The engagement element has at least one first groove, and a groove direction assigned to the at least one first groove is aligned along the axial direction of the hollow medical body when the closure is placed on the hollow medical body in the closed position. In particular, the first groove is configured on the engagement protrusion.

[0009] In the context of the present technical teachings, the groove direction assigned to a groove is the direction of a straight line extending from the start point of the groove to the end point of the groove, where the start point of the groove and the end point of the groove are preferably spaced apart along the longest extent of the groove.

[0010] When the groove direction and the axial direction of the hollow medical body form an angle of less than 90°, preferably 45° or less, the groove direction is aligned along the axial direction of the hollow medical body.

[0011] Advantageously, the closure, and in particular the engagement element, seals and closes the hollow medical body when the closure is placed on the hollow medical body in the closed position. Advantageously, the engagement element is in contact, in particular in fluid contact, with a product present within the hollow medical body when the closure is placed on the hollow medical body in the closed position.

[0012] Advantageously, the groove forms a fluid connection between the interior of the hollow medical body and the exterior of the hollow medical body when the closure is released from the closed position, and preferably the engagement element still engages within the distal opening of the hollow medical body. This fluid connection advantageously allows for a more gentle pressure equalization compared to known closures, which can advantageously reduce droplet formation at least at the distal opening of the hollow medical body and reduce loss of product present within the hollow medical body.

[0013] Preferably, the engagement element is configured to rest sealingly against or on an end face of the distal region of the hollow medical body when the closure is disposed on the hollow medical body in its closed position, the end face of the distal region being in particular an end face of the distal opening.

[0014] Preferably, the part of the engagement element that engages in the distal opening of the hollow medical body, in particular the conically configured engagement protrusion, is in sealing contact with the hollow medical body, in particular the inner wall of the hollow medical body, at least in some areas, in particular outside the first groove.

[0015] The axial direction of the hollow medical body preferably extends along the longest direction of the hollow medical body, preferably along the axis of symmetry of a rotationally symmetric hollow medical body. The radial direction is perpendicular to the axial direction. The circumferential direction concentrically surrounds the axial direction.

[0016] In particular, the engaging element has an underside that at least partially faces an end surface of the distal opening of the hollow medical body when the closure is disposed on the hollow medical body in the closed position.

[0017] Preferably, the hollow medical body is configured as a syringe.

[0018] Preferably, the product present within the hollow medical body is a medical product or a pharmaceutical product, in particular a medical liquid or a pharmaceutical liquid.

[0019] According to a further development of the invention, it is provided that at least one first groove has a longitudinal groove extension extending linearly in the groove direction, preferably forming an angle between the longitudinal groove extension and the axial direction of the hollow medical body of 0° to 25° when the closure is placed on the hollow medical body in the closed position.

[0020] Preferably, when the closure is placed on the hollow medical body in the closed position, the longitudinal groove extensions and the axial direction of the hollow medical body are aligned parallel to one another.

[0021] According to a further development of the invention, it is provided that the at least one first groove is formed along a space curve, in particular a helical line or a conical helix. The space curve extends along the winding axis. Preferably, the winding axis of the at least one first groove and the axial direction of the hollow medical body are parallel to each other when the closure is placed on the hollow medical body in the closed position.

[0022] The groove direction of the at least one first groove is determined by the start point of the spatial curve and the end point of the spatial curve, in particular, the groove direction of the at least one first groove extending along the spatial curve and the axial direction of the hollow medical body form an angle of less than 90°, particularly preferably less than or equal to 45°, when the closure is placed on the hollow medical body in the closed position.

[0023] Preferably, the first groove configured as a conical spiral has a pitch height of 0.5 mm to 2 mm, preferably 1 mm. Alternatively or additionally, the spiral first groove has at least 1 turn, preferably 1 to 3 turns, particularly preferably 1.75 turns. Alternatively or additionally, the spiral first groove has a taper of 0° to 45°, preferably 20°.

[0024] Alternatively or additionally, the groove width of the first groove has a taper of between 0° and 45°, preferably 20°.

[0025] According to a further development of the invention, it is provided that the engagement element, in particular the engagement protrusion of conical configuration, has at least one second groove extending in a plane, the normal of which when the closure is placed on the hollow medical body in the closed position forms an angle of 0° to 18° with the axial direction of the hollow medical body.

[0026] Preferably, the normal direction of the plane and the longitudinal groove extension of the first groove are aligned parallel to one another.Alternatively or additionally, the normal direction of the plane and the axial direction of the hollow medical body when the closure is disposed on the hollow medical body in the closed position are preferably aligned parallel to one another.

[0027] When the closure is released from the closed position, preferably while the engagement element is still engaged in the distal opening of the hollow medical body, gas is advantageously guided from the interior of the hollow medical body to the second groove by the first groove, in particular the second groove being in fluid connection with the exterior of the hollow medical body, regardless of how the closure is released from the closed position, in particular in what direction or angle with respect to the axial direction of the hollow medical body. Thus, a more relaxed pressure equalization is possible compared to known closures, regardless of how the closure is removed from the hollow medical body.

[0028] According to a further development of the invention, it is provided that the closure has a sealing element, which is configured to be in sealing contact with at least a distal region of the hollow medical body when the closure is arranged on the hollow medical body in the closed position.

[0029] Advantageously, the sealing element does not come into contact with the product present within the hollow medical body when the closure is placed on the hollow medical body in the closed position, especially when the sealing element and the engagement element are constructed in two parts.

[0030] In a preferred form, the sealing element is configured to sealingly surround at least a distal region of the hollow medical body when the closure is disposed on the hollow medical body in the closed position.

[0031] According to a further development of the invention, it is provided that the sealing element and the engagement element are formed integrally, preferably from the same material, which advantageously allows the sealing element and the engagement element to be manufactured in one step, which saves time and costs.

[0032] According to a further development of the invention, it is provided that the sealing element and the engagement element are constructed in two parts. Advantageously, this allows the sealing element and the engagement element to be produced in a simple manner from different materials and in particular allows them to be adapted to special requirements. Advantageously, it is also possible to produce the engagement element from materials that cannot be processed by injection molding processes.

[0033] In one embodiment of the closure, the engagement element is received in at least a partial area in the sealing element, in particular in a recess of the sealing element provided for this purpose, in particular the sealing element circumferentially surrounding the engagement element.

[0034] In particular, due to the particularly permanent contact with the product present within the hollow medical body, in particular during transport and / or storage, it is advantageous to select the material of the engaging element such that it is stable towards the product, in particular chemically stable and preferably does not migrate into the product.

[0035] According to a further development of the invention, it is provided that the engaging element has a circumferentially extending sealing lip, which is arranged on the engaging element such that when the closure is arranged on the hollow medical body in the closed position, the sealing lip rests on the end face of the distal opening of the hollow medical body.

[0036] Advantageously, the sealing lip forms an additional seal within the hollow medical body, particularly in addition to the region of the engaging element that engages the distal opening of the hollow medical body, and particularly between the product and the exterior of the hollow medical body.

[0037] In particular, the sealing lip is disposed on the underside of the engagement element such that the sealing lip at least partially opposes an end surface of the distal opening of the hollow medical body when the closure is disposed on the hollow medical body in the closed position.

[0038] According to a further development of the invention, it is provided that the closure has a base body. The engagement element is at least partially arranged in the base body. Alternatively or additionally, the sealing element is at least partially arranged in the base body.

[0039] Advantageously, the base body does not contact a product present within the hollow medical body when the closure is placed on the hollow medical body in the closed position.

[0040] Preferably, the base body surrounds the sealing element and the engagement element.

[0041] Particularly preferably, the sealing element is arranged on the base body such that it comes into sealing contact with at least a distal region of the hollow medical body when the closure is arranged on the hollow medical body in the closed position.Alternatively or additionally, the engagement element is particularly preferably arranged on the base body such that it engages with at least a partial region of the distal opening of the hollow medical body (particularly with an engagement protrusion configured in a conical shape) when the closure is arranged on the hollow medical body in the closed position.

[0042] According to a further development of the invention, it is provided that the base body has an internal thread which engages around the periphery of the distal region of the hollow medical body when the closure is placed on the hollow medical body in the closed position, the internal thread being preferably a Luer thread.

[0043] Advantageously, this allows a device for applying the product, in particular an adapter or a cannula, to be easily connected to the hollow medical body by means of the closure.

[0044] According to a further development of the invention, it is provided that the sealing element and the engagement element are arranged in the base body so as to be spaced apart from each other in at least one first region along the longitudinal groove extension and thereby rest against each other in at least one second region.

[0045] Advantageously, the position of the engagement element relative to the sealing element and the base body is fixed by at least one second region, which further advantageously has the function of pressing the engagement element, preferably against the distal opening of the hollow medical body, when the closure is placed on the hollow medical body in the closed position.

[0046] Preferably, the second region is configured to compensate for manufacturing tolerances of at least one element selected from the group consisting of the base body, the sealing element and the engagement element.

[0047] In particular, the at least one first region is a recess, in particular a cavity, between the engagement element and the sealing element.

[0048] Advantageously, the at least one first region can thus avoid the pressure present when the engaging element is pressed into the hollow medical body by displacing the engaging element at least partially into the at least one first region when the closure is placed on the hollow medical body in the closed position, allowing the engaging element to be therefore only at least partially compressed.

[0049] Advantageously, when the closure is placed on the hollow medical body in the closed position, the sealing lip makes it possible to achieve airtightness of the hollow medical body even if the contact pressure of the engagement element against the end face of the distal opening of the hollow medical body is reduced, particularly under environmental influences and / or during sterilization procedures that may lead to a reduction in the contact pressure.

[0050] According to a further development of the invention, it is provided that the base body has an upper part and a lower part, the lower part preferably having an internal thread. The upper part and the lower part are connected to each other by a number of ribs.

[0051] Advantageously, the ribs make it possible to separate the upper and lower parts from each other in a simple manner, in particular irreversibly, and in particular advantageously to reduce the force required to open the closure and at the same time provide opening detection.

[0052] Preferably, the internal thread, in particular the luer thread, and the base body, in particular the lower part, are made in two parts. Alternatively, the internal thread, in particular the luer thread, and the base body, in particular the lower part, are preferably made in one piece.

[0053] In a preferred form, the upper and lower parts are configured such that, while the closure is released from the closed position, the upper and lower parts are separated from each other, in particular irreversibly, while the lower part remains disposed on the hollow medical body. Furthermore, the upper part, the sealing element and the engagement element are connected to each other such that, while the closure is released from the closed position, the sealing element and the engagement element are also separated from the hollow medical body together with the upper part.

[0054] Preferably, the axial direction of the upper part, the axial direction of the lower part and the axial direction of the hollow medical body are aligned parallel to each other, in particular identically, in the closed position. Particularly preferably, the closure is released from the closed position by tilting the upper part relative to the axial direction of the lower part in an opening direction perpendicular to the axial direction of the hollow medical body, and thus in particular to the axial direction of the lower part, so that at least one rib of the plurality of ribs is stretched and at least one rib of the plurality of ribs is crushed. In particular, all ribs of the plurality of ribs are irreversibly broken during tilting, so that the upper part and the lower part can be separated from each other. Particularly preferably, the opening direction is directed in the opposite direction to the groove opening direction of the first groove.

[0055] In the context of the present technical teachings, the groove opening direction is oriented in a direction perpendicular to the plane in which the groove is inserted. Additionally, the groove opening direction is aligned perpendicular to the longitudinal groove extension.

[0056] Preferably, the upper and lower portions of the base body are connected by up to eight ribs.

[0057] In a preferred form, the base body has an upper portion, a lower portion, and a plurality of ribs connecting the upper portion and the lower portion. Additionally, the engagement element has a sealing lip. When the closure is placed on the hollow medical body in the closed position, the sealing lip allows for a reduced contact pressure of the engagement element against an end surface of the distal opening of the hollow medical body. This advantageously reduces tension in the ribs, and thus deformation of the ribs, particularly during heating when sterilizing a hollow medical body sealed with the closure.

[0058] According to a further development of the invention, it is provided that the closure has a holding element arranged on the base body such that when the closure is arranged on the hollow medical body in the closed position, the holding element preferably grips the hollow medical body with a positive and / or frictional connection. Furthermore, the holding element has at least one anti-rotation part which engages in a recess of the base body, in particular in the lower part of the base body.

[0059] Advantageously, the retaining element allows the lower portion to remain disposed in the hollow medical body while the closure is released from the closed position, and further, the anti-rotation portion secures the base body of the closure to the retaining element such that it cannot rotate.

[0060] Preferably, the retaining element is disposed on the base body before the closure is placed on the hollow medical body in the closed position.

[0061] It is particularly preferred that the retaining element is latched to the base body before the closure is placed on the hollow medical body in the closed position.

[0062] In a preferred form, the retaining element and the plurality of ribs advantageously interact such that, during release of the closure from the closed position, the upper and lower portions are separated from each other, in particular irreversibly, and the lower portion remains disposed on the hollow medical body.

[0063] According to a further development of the invention, it is provided that the base body and the sealing element are manufactured by a two-component injection molding process. Alternatively, the base body, the sealing element and the engagement element are manufactured by a multi-component injection molding process, in particular a two-component injection molding process.

[0064] Advantageously, this allows the base body, the sealing element, and preferably the engagement element to be manufactured in one step, saving time and costs. Advantageously, no additional steps are required to connect the base body, the sealing element, and preferably the engagement element to each other.

[0065] According to a further development of the invention, it is provided that the sealing element comprises at least one thermoplastic elastomer (TPE) or alternatively that the sealing element consists of at least one thermoplastic elastomer (TPE).

[0066] Advantageously, thermoplastic elastomers can be easily processed by injection molding processes.

[0067] According to a further development of the invention, it is provided that the engaging element comprises at least one elastomer. Alternatively, it is provided that the engaging element consists of at least one elastomer. Advantageously, the elastomer is stable towards a number of products that may be present inside the hollow medical body, in particular chemically stable. Furthermore, a good seal between the inside and the outside of the hollow medical body can advantageously be achieved with an engaging element made from at least one elastomer.

[0068] In particular, the engagement element preferably comprises at least one rubber material or preferably consists of at least one rubber material.

[0069] Preferably, the at least one elastomer is a vulcanizate of rubber. Alternatively, the at least one elastomer is particularly preferably a vulcanizate of silicone rubber. Alternatively or additionally, the at least one elastomer is preferably selected from the group consisting of halogenated butyl rubber, in particular bromobutyl rubber, chlorobutyl rubber, polyisoprene rubber, polybutadiene rubber, ethylene-propylene copolymer rubber, ethylene-propylene-diene copolymer rubber, chlorosulfonated polyethylene rubber, ethylene-vinyl acetate copolymer rubber, styrene-isoprene copolymer rubber, fluoroelastomer rubber, perfluoroelastomer rubber, tetrafluoroethylene rubber, propylene rubber, butyl rubber, isoprene rubber, butadiene rubber, ethylene-propylene terpolymer rubber, silicone rubber, and styrene-butadiene copolymer rubber.

[0070] Advantageously, the engaging element, which comprises or consists of at least one elastomer, in particular at least one rubber material, prevents the contents of the hollow medical body from coming into primary contact with the sealing element and thus, possibly, with less suitable materials. In particular, an engaging element consisting of a material different from that of the sealing element prevents the contents of the hollow medical body from coming into primary contact with the thermoplastic elastomer.

[0071] In a preferred embodiment, the engaging element and the sealing element are integral and made of the same material. Preferably, the engaging element and the sealing element have at least one thermoplastic elastomer (TPE). Alternatively, it is preferred that the engaging element and the sealing element consist of at least one thermoplastic elastomer (TPE). Alternatively, it is preferred that the engaging element and the sealing element have at least one elastomer, in particular at least one rubber material. Alternatively, it is preferably provided that the engaging element and the sealing element consist of at least one elastomer, in particular at least one rubber material.

[0072] In a further preferred embodiment, the engaging element and the sealing element are constructed as one piece. Particularly preferably, the sealing element is molded onto the engaging element. Alternatively or additionally, the engaging element and the sealing element are in particular fused. Preferably, the sealing element comprises at least one thermoplastic elastomer (TPE). Alternatively, it is preferably provided that the sealing element consists of at least one thermoplastic elastomer (TPE). Alternatively or additionally, the engaging element preferably comprises at least one elastomer, in particular at least one rubber material. Alternatively or additionally, it is preferably provided that the engaging element consists of at least one elastomer, in particular at least one rubber material.

[0073] According to a further development of the invention, it is provided that the base body has a first concave grip and a second concave grip, the first concave grip and the second concave grip being formed on the side surface of the base body. Preferably, the first concave grip and the second concave grip are arranged diametrically opposite each other. Alternatively or additionally, the first concave grip and the second concave grip are preferably formed on the lower part of the base body.

[0074] Advantageously, the concave grip allows the closure to be grasped in a simple manner, in particular to hold the lower part in order to place the closure on the hollow medical body in the closed position, or to separate in a particularly irreversible manner the lower and upper parts of the base body when the closure is opened.

[0075] Advantageously, the recessed grip further improves the visual, tactile impression and ergonomics of the closure.

[0076] According to a further development of the invention, it is provided that the base body has at least one recess. Furthermore, the sealing element has at least one anchor element, the sealing element being arranged on the base body such that the at least one anchor element engages in the at least one recess.

[0077] Advantageously, it is possible to connect the base body and the sealing element to one another in a simple manner by means of at least one anchor element operatively connected to the at least one recess.

[0078] Preferably, the at least one anchor element is configured to protrude axially from the at least one recess, in particular in the axial direction of the base body. Alternatively or additionally, preferably, the at least one anchor element is configured to protrude radially from the at least one recess, in particular in the radial direction of the base body.

[0079] Furthermore, at least one recess is particularly preferably configured in the upper part of the base body.

[0080] Advantageously, at least one anchor element protruding from the at least one recess allows the closure to be gripped in a simple manner, in particular the upper part to be held firmly in order to place the closure on the hollow medical body in the closed position, or the lower part and the upper part of the base body to be separated in a particularly irreversible manner when the closure is opened.

[0081] Preferably, the at least one recess and the at least one anchor element have an arrow shape, and a preferred opening direction of the closure can be represented by the at least one recess and the at least one anchor element.

[0082] This problem is also solved by creating a hollow medical body equipped with a closure according to the invention or according to one or more of the above-mentioned embodiments, in connection with the hollow medical body the advantages already explained in connection with the closure arise in particular.

[0083] The problem is also solved by creating a method for manufacturing a closure according to the invention or according to one or more of the above-mentioned embodiments, in which the base body and the sealing element are manufactured by a two-component injection molding process. Alternatively, the base body, the sealing element and the engagement element are preferably manufactured by a two-component or multi-component injection molding process. As part of the method, in particular the closure according to the invention or according to one or more of the above-mentioned embodiments is obtained. In connection with this method, in particular the advantages already explained in connection with the closure and the hollow medical body arise. [Brief description of the drawings]

[0084] The present invention will now be described in more detail with reference to the drawings. [Figure 1] FIG. 2 is a schematic diagram of a first embodiment of a closure. [Diagram 2] FIG. 4 is a schematic diagram of a second embodiment of the closure. [Diagram 3] FIG. 13 is a schematic diagram of a third embodiment of the closure. [Figure 4] FIG. 13 is a schematic diagram of a fourth embodiment of a closure. [Diagram 5] FIG. 1 is a schematic diagram of a first embodiment of a hollow medical body. [Figure 6] FIG. 13 is a schematic diagram of a fifth embodiment of the closure. [Figure 7] FIG. 13 is a schematic diagram of a sixth embodiment of the closure. [Figure 8] FIG. 2 is a schematic diagram of a second embodiment of a hollow medical body. [Figure 9] FIG. 13 is a schematic diagram showing a third embodiment of a hollow medical body. [Figure 10] FIG. 13 is a schematic diagram of a fourth embodiment of a hollow medical body. [Figure 11] FIG. 13 is a schematic cross-sectional view of a seventh embodiment of the closure. [Figure 12] FIG. 2 is a flow diagram of a first embodiment of a method for manufacturing a closure. [Figure 13] FIG. 6 is a flow diagram of a second embodiment of a method for manufacturing a closure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0085] FIG. 1 is a schematic diagram of a first embodiment of a closure 1 .

[0086] The closure 1 has an engagement element 9 that is configured to at least partially engage (particularly at the engagement protrusion 10) with a distal opening 13 of the hollow medical body 3 when the closure 1 is placed on the hollow medical body 3 in the closed position. The engagement element 9 has (particularly on the engagement protrusion 10) at least one first groove 15.1, which is assigned a groove direction 16. When the closure 1 is placed on the hollow medical body 3 in the closed position, the groove direction 16 is aligned along an axial direction 19 of the hollow medical body 3.

[0087] Preferably, at least one first groove 15.1 has a longitudinal groove extension 17 which extends linearly in the groove direction 16.

[0088] Particularly preferably, the longitudinal groove extension 17 and the axial direction 19 of the hollow medical body 3 form an angle between 0° and 25°, in particular 21°, when the closure 1 is placed on the hollow medical body 3 in the closed position.

[0089] FIG. 2 is a schematic diagram of a second embodiment of a closure 1 with an engagement element 9 .

[0090] Identical and functionally identical elements are provided with the same reference signs in all figures, and reference is made in each case to the previous description.

[0091] The at least one first groove 15.1 is configured along a conical spiral, in particular the first groove 15.1 is configured as a conical spiral. Preferably, the winding axis 18 of the at least one first groove 15.1 and the axial direction 19 of the hollow medical body 3 are parallel to each other when the closure 1 is placed on the hollow medical body 3 in the closed position.

[0092] The groove direction 16 assigned to the at least one first groove 15.1 is the direction of a straight line extending from a starting point 20.1 of the at least one first groove 15.1 to an end point 20.2 of the at least one first groove 15.1, the starting point 20.1 and the end point 20.2 being spaced apart along the longest extent of the at least one first groove 15.1.

[0093] Particularly preferably, the conical helix has a pitch height of 0.5 mm to 2 mm, preferably 1 mm. Alternatively or additionally, the helical first groove 15.1 has 1 to 3 turns, preferably 1.75 turns. Alternatively or additionally, the helical first groove 15.1 has a taper of 0° to 45°, preferably 20°.

[0094] FIG. 3 is a schematic diagram of a third embodiment of a closure 1 with an engagement element 9 .

[0095] The first groove 15.1 is clearly visible. In the embodiment of the engagement element shown in figure 3, the longitudinal groove extension 17 and the axial direction 19 are aligned parallel to one another and are particularly preferably coincident.

[0096] Preferably, the engagement element 9 also has at least one second groove 15.2 (in particular on the engagement projection 10) extending in a plane, the normal to the plane being aligned along the longitudinal groove extension 17 of the first groove 15.1. Particularly preferably, the normal to the plane and the longitudinal groove extension 17 are aligned parallel to each other.

[0097] Additionally, the closure 1 (particularly the engagement element 9) has a circumferentially extending sealing lip 31. The sealing lip 31 is configured on the engagement element 9 and is arranged such that when the closure 1 is placed on the hollow medical body 3 in the closed position, the sealing lip 31 rests on an end surface 33 of the distal opening 13 of the hollow medical body 3.

[0098] FIG. 4 is a schematic diagram of a fourth embodiment of a closure 1 with an engagement element 9 .

[0099] In particular the first groove 15.1, whose longitudinal groove extension 17 forms a positive angle with the axial direction 19, the second groove 15.2 and the circumferentially extending sealing lip 31 are clearly recognizable.

[0100] In particular, the normal to the plane in which the second groove 15.2 extends makes an angle of 0°-18° with the axial direction 19 of the hollow medical body 3 when the closure 1 is placed on the hollow medical body 3 in the closed position.

[0101] FIG. 5 shows a schematic view of a first embodiment of a hollow medical body 3 with a closure 1 placed on the hollow medical body 3 in a closed position.

[0102] The engagement element 9 is constructed and arranged to engage at least in a portion of the distal opening 13 of the hollow medical body 3 (particularly at the conically configured engagement protrusion 10) when the closure 1 is placed on the hollow medical body 3 in the closed position. Furthermore, the longitudinal groove extension 17 is aligned along the axial direction 19 of the hollow medical body 3 when the closure 1 is placed on the hollow medical body 3 in the closed position.

[0103] In particular, the closure 1 has a sealing element 7 in addition to the engagement element 9. The sealing element 7 is configured to be in sealing contact with at least a distal region 11 of the hollow medical body 3 when the closure 1 is disposed on the hollow medical body 3 in the closed position.

[0104] In the embodiment shown in FIG. 5, the sealing element 7 and the engagement element 9 are made of two parts.

[0105] Preferably, the sealing element 7 comprises at least one thermoplastic elastomer (TPE). Alternatively, the sealing element 7 is particularly preferably made of at least one thermoplastic elastomer (TPE).

[0106] Preferably, the engaging element 9 comprises at least one elastomer, in particular at least one rubber. Alternatively, the engaging element 9 is particularly preferably made of at least one elastomer, in particular at least one rubber.

[0107] Particularly preferably, the sealing element 7 and the engagement element 9 are configured and arranged to be spaced apart from one another in at least one first region 39.1 in the direction of the longitudinal groove extension 17. Furthermore, the sealing element 7 and the engagement element 9 preferably rest on one another in a point-like or flat state in at least one second region 39.2. The second region 39.2 in particular serves as a spring element which presses the engagement element 9 against the end face 33 of the hollow medical body 3 in the closed position.

[0108] FIG. 6 is a schematic diagram of a fifth embodiment of a closure 1 for a hollow medical body 3. The closure 1 has a base body 5, a sealing element 7 and an engagement element 9. The sealing element 7 is arranged in the base body 5 such that it is in sealing contact with at least a distal region 11 of the hollow medical body 3 when the closure 1 is arranged on the hollow medical body 3 in the closed position. Furthermore, the engagement element 9 is configured and arranged in the base body 5 such that it is engaged in at least a partial region with a distal opening 13 of the hollow medical body 3 (particularly with an engagement projection 10 configured in a conical shape) when the closure 1 is arranged on the hollow medical body 3. Furthermore, the engagement element 9 (particularly with an engagement projection 10 configured in a conical shape) has at least a first groove 15.1 with a longitudinal groove extension 17. When the closure 1 is placed on the hollow medical body 3 in the closed position, the longitudinal groove extension 17 is aligned along the axial direction 19 of the hollow medical body 3, and in particular, when the closure 1 is placed on the hollow medical body 3 in the closed position, the longitudinal groove extension 17 and the axial direction 19 of the hollow medical body 3 are aligned parallel to each other.

[0109] Preferably, the base body 5 at least partially surrounds the sealing element 7 and the engagement element 9 .

[0110] The base body particularly preferably has an upper part 21.1 and a lower part 21.2, which are further preferably connected to one another by a number of ribs 23.

[0111] Preferably, the engagement element 9 (in particular the conically configured engagement projection 10) has at least one second groove 15.2 extending in a plane, the normal to the plane being aligned along the longitudinal groove extension. Particularly preferably, the normal to the plane and the longitudinal groove extension are aligned parallel to each other.

[0112] In the embodiment shown, the sealing element 7 and the engagement element 9 are in particular constructed in one piece from the same material.

[0113] Furthermore, the base body 5, in particular the lower portion 21.2 of the base body 5, preferably has an internal thread 25 which engages around the distal region 11 of the hollow medical body 3 when the closure 1 is placed on the hollow medical body 3 in the closed position. Furthermore, the internal thread 25 is particularly preferably configured as a Luer thread.

[0114] Preferably, the internal thread 25, in particular the luer thread, and the base body 5, in particular the lower part 21.2, are constructed in two parts. Alternatively, the internal thread 25, in particular the luer thread, and the base body 5, in particular the lower part 21.2, are preferably constructed in one piece.

[0115] Furthermore, the base body 5, in particular the top part 21.1 of the base body 5, preferably has at least one recess 27. Furthermore, the sealing element 7 preferably has at least one anchor element 29, the sealing element 7 being arranged in the base body 5 such that the at least one anchor element 29 engages in the at least one recess 27.

[0116] Preferably, the sealing element 7 comprises at least one thermoplastic elastomer (TPE). Alternatively, the sealing element 7 particularly preferably consists of at least one thermoplastic elastomer (TPE).

[0117] FIG. 7 is a schematic diagram of a sixth embodiment of a closure 1 for a hollow medical body 3 .

[0118] The sixth embodiment of the closure 1 includes, in addition to the fifth embodiment of the closure 1 of Fig. 6, a circumferentially extending sealing lip 31. The sealing lip 31 is configured on the engagement element 9 and is positioned such that when the closure 1 is placed on the hollow medical body 3 in the closed position, the sealing lip 31 rests on the end surface 33 of the distal opening 13 of the hollow medical body 3.

[0119] FIG. 8 shows a schematic view of a second embodiment of a hollow medical body 3 with a closure 1 placed on the hollow medical body 3 in a closed position.

[0120] The closure 1 preferably has a separate retaining element 35. The retaining element 35 is preferably arranged on the base body 5 of the closure 1 such that when the closure 1 is placed on the hollow medical body 3 in the closed position, the retaining element 35 grips the hollow medical body 3 with a positive and / or frictional fit.

[0121] Preferably, the base body 5, in particular the top portion 21.1 of the base body 5, has a plurality of recesses 27, in particular seven recesses 27. Furthermore, the sealing element 7 has a plurality of anchor elements 29, in particular seven anchor elements 29, in particular the number of recesses 27 and the number of anchor elements 29 are identical. Preferably, at least one anchor element 29 of the plurality of anchor elements 29 is configured as a radial anchor element 29.1, in particular the sealing element 7 has six radial anchor elements 29.1 projecting radially from the respective recess 27. Furthermore, at least one anchor element 29 of the plurality of anchor elements 29 is preferably configured as an axial anchor element 29.2, in particular the sealing element 7 has an axial anchor element 29.2 projecting axially from the associated recess 27. For the sake of clearer representation, only one radial anchor element 29.1 and axial anchor element 29.2 and the respective associated recess 27 are numbered.

[0122] Furthermore, the base body 5, in particular the lower part 21.2 of the base body 5, preferably has a first concave grip 37.1 and a second concave grip 37.2, which are arranged on the lateral sides of the base body 5. Particularly preferably, the first concave grip 37.1 and the second concave grip 37.2 are arranged diametrically opposite each other.

[0123] Fig. 9 shows a schematic view of a third embodiment of a hollow medical body 3 with a closure 1 arranged on the hollow medical body 3 in a closed position. Fig. 9a) shows a first view of the hollow medical body 3 and Fig. 9b) shows a second view of the hollow medical body 3, the second view emerging from the first view by the hollow medical body 3 being rotated preferably 90° with respect to the axial direction 19 when the first groove 15.1 is rotated backwards with respect to the image plane.

[0124] The sealing element 7 and the engagement element 9 are preferably constructed in two parts, the engagement element 9 particularly preferably having a first groove 15.1, a second groove 15.2 and a sealing lip 31.

[0125] FIG. 9 a ) shows one of the recesses 27 visible on one end face of the base body 5 , from which an axial anchor element 29 . 2 arranged in particular on the sealing element 7 protrudes in the axial direction 19 .

[0126] Furthermore, the radial anchor elements 29.1 are not visible in FIG. 9a).

[0127] In figure 9b), analogous to figure 8, six recesses 27 can be seen on the side of the base body 5, in particular on the side of the upper part 21.1 of the base body 5, with a radial anchor element 29 engaging and projecting radially in each of the six recesses 27. For a clearer representation, only one radial anchor element 29.1 and the associated recess 27 are numbered.

[0128] The first groove 15.1 of the engagement element 9 is not visible in FIG. 9b) because it is rotated.

[0129] Furthermore, the first concave grip 37.1 and the second concave grip 37.2 are not visible in FIG. 9b).

[0130] Comparing the two figures, 9a) and 9b), it can be seen that both the radial anchor elements 29.1 as well as the first concave grips 37.1 and the second concave grips 37.2 are formed only in certain circumferential regions.

[0131] FIG. 10 is a schematic view of a third embodiment of a hollow medical body 3 with a closure 1 .

[0132] 10 shows an external view of a hollow medical body 3 with a closure 1. It is therefore also possible for the sealing element 7 and the engagement element 9 to be constructed integrally with one another. Alternatively, however, it is also possible for the sealing element 7 and the engagement element 9 to be constructed in two parts.

[0133] The axial anchor element 29.2 is preferably configured as an arrow, in order to advantageously indicate a particularly preferred opening direction.

[0134] Preferably, the radial anchor element 29.1 is only partially configured along the circumferential direction of a side surface of the upper part 21.1 of the base body 5. Alternatively or additionally, the first concave grip 37.1 is only partially configured along the circumferential direction of a side surface of the lower part 21.2 of the base body 5. Preferably, the radial anchor element 29.1, the first concave grip 37.1 and the second concave grip 37.2 are configured such that the closure 1 can be easily and securely gripped.

[0135] FIG. 11 shows a schematic cross-sectional view of a seventh embodiment of the closure 1, in particular with a retaining element 35 arranged on the underside of the lower part 21.2 of the base body 5.

[0136] Preferably, the retaining element 35 has an anti-rotation portion 41 which engages in a recess 43 in the base body 5, in particular in the lower part 21.2 of the base body 5. In particular, the retaining element 35 is pressed into the base body 5, in particular in the lower part 21.2 of the base body 5 (in the figure pressed from the left) during assembly of the closure 1.

[0137] Preferably, the holding element 35 has a clamping shape, in particular a plurality of teeth 45, configured and arranged to grip the hollow medical body 3, in particular the distal region 11 of the hollow medical body 3, with a positive and / or frictional fit. An inner diameter 47 of the holding element 35 is particularly preferably smaller than the diameter of the distal region 11 of the hollow medical body 3, in which the closure 1 is arranged. Due to the plurality of teeth 45, the holding element 35 is partially flexible so that the closure 1 can be arranged on the hollow medical body 3 in the closed position.

[0138] Particularly preferably, the retaining element 35 is latched to the base body 5 before the closure 1 is placed on the hollow medical body 3 in the closed position.

[0139] FIG. 12 is a flow diagram of a first embodiment of a method for manufacturing the closure 1. As shown in FIG.

[0140] In a first initial step a1), the base body 5 and the sealing element 7 are manufactured by means of a two-component injection molding process. Preferably, the sealing element 7 is manufactured from at least one thermoplastic elastomer.

[0141] In a second initial step a2), the engaging element 9 is preferably manufactured from at least one elastomer. Preferably, the at least one elastomer is a rubber vulcanizate and / or a silicone rubber vulcanizate.

[0142] In a second step b), the engaging element 9 is placed on the base body 5 and the sealing element 7 and the closure 1 is produced.

[0143] In an optional third step c), the retaining element 35 is preferably arranged on the base body 5. Particularly preferably, the retaining element 35 is connected to the base body 5 by means of at least one anti-rotation feature 41 which engages in at least one recess 43 of the base body 5.

[0144] In an optional fourth step d), the closure 1 is preferably placed in the closed position on the hollow medical body 3 .

[0145] FIG. 13 shows a flow diagram of a second embodiment of a method for manufacturing the closure 1.

[0146] In a first step a), the base body 5, the sealing element 7 and the engaging element 9 are manufactured using a two-component or multi-component injection molding process, whereby the sealing element 7 and the engaging element 9 are configured integrally with one another. Preferably, the integral form of the sealing element 7 and the engaging element 9 are manufactured from at least one thermoplastic elastomer.

[0147] Thus, the closure 1 is manufactured in one step, in particular in a first step a).

[0148] In an optional third step c), the retaining element 35 is preferably arranged on the base body 5. Particularly preferably, the retaining element 35 is connected to the base body 5 by means of at least one anti-rotation feature 41 which engages in at least one recess 43 of the base body 5.

[0149] In an optional fourth step d), the closure 1 is preferably placed in the closed position on the hollow medical body 3 .

Claims

Claim 1 A closure (1) for a hollow medical body (3), comprising an engaging element (9) configured to engage at least in part with a distal opening (13) of the hollow medical body (3) when the closure (1) is disposed on the hollow medical body (3) in a closed position; the engaging element (9) has at least one first groove (15.1), and a groove direction (16) assigned to the at least one first groove (15.1) is aligned along an axial direction (19) of the hollow medical body (3) when the closure (1) is disposed on the hollow medical body (3) in the closed position. Claim 2 The at least one first groove (15.1) has a longitudinal groove extension (17) extending linearly in the groove direction (16), preferably, when the closure (1) is disposed on the hollow medical body (3) in the closed position, the axial direction (19) of the hollow medical body (3) forms an angle of 0° to 25° with the longitudinal groove extension (17). The closure (1) according to claim 1. Claim 3 The at least one first groove (15.1) is configured along a space curve, in particular a helix or a conical helix, the space curve extends around a winding axis (18), preferably, when the closure (1) is disposed on the hollow medical body (3) in the closed position, the winding axis (18) of the at least one first groove (15.1) and the axial direction (19) of the hollow medical body (3) are parallel to each other. The closure (1) according to claim 1. Claim 4 The engaging element (9) has at least one second groove (15.2) extending in a plane, and when the closure (1) is disposed on the hollow medical body (3) in the closed position, a normal direction of the plane and the axial direction (19) of the hollow medical body (3) form an angle of 0° to 18°. The closure (1) according to claim 2. Claim 5 Having a sealing element (7), the sealing element (7) is configured to seal and support at least one distal region (11) of the hollow medical body (3) when the closure (1) is disposed on the hollow medical body (3) in the closed position. The closure (1) according to any one of claims 1 to 4. Claim 6 The closure (1) according to claim 5, wherein the sealing element (7) and the engaging element (9) are integrally formed with each other.

7. The closure (1) according to claim 5, wherein the sealing element (7) and the engaging element (9) are composed of two parts.

8. The engaging element (9) extends in the circumferential direction, and when the closure (1) is disposed on the hollow medical body (3) in the closed position, a sealing lip (31) is disposed on the engaging element (9) such that the sealing lip (31) rests on an end face (33) of the distal opening (13) of the hollow medical body (3). The closure (1) according to any one of claims 1 to 4.

9. The closure (1) according to claim 5, comprising a base body (5), wherein the engaging element (9) and / or the sealing element (7) are at least partially disposed within the base body.

10. The base body (5) has an internal thread (25) that engages around a distal region (11) of the hollow medical body (3) when the closure (1) is disposed on the hollow medical body (3) in the closed position. The internal thread (25) is preferably a luer thread. The closure (1) according to claim 9.

11. The sealing element (7) and the engaging element (9) are disposed within the base body so as to be spaced apart from each other in at least one first region (39.1) along the longitudinal groove extension (17), and are adapted to be stationary with respect to each other in at least one second region (39.2). The closure (1) according to claim 9, which depends on claim 5, which depends on claim 2.

12. The base body (5) comprises an upper part (21.1) and a lower part (21.2), The upper part (21.1) and the lower part (21.2) are connected by a plurality of ribs (23), and preferably, The lower part (21.2) has the internal thread (25). The closure (1) according to claim 10.

13. When the closure (1) is arranged on the hollow medical body (3) in the closed position, it is preferably arranged on the base body (5) so as to engage in a form - fit and / or friction - fit manner around the hollow medical body (3). The retaining element (35) has at least one anti - rotation part (41) that engages within a recess (43) of the base body (5). The closure (1) according to claim 9.

14. The closure (1) according to claim 9, wherein the base body (5), the sealing element (7), and preferably the engaging element (9) are manufactured by a two - component injection - molding process.

15. The closure (1) according to claim 5, wherein the sealing element (7) comprises at least one thermoplastic elastomer (TPE), preferably consists of at least one thermoplastic elastomer (TPE).

16. The closure (1) according to any one of claims 1 to 4, wherein the engaging element (9) comprises at least one elastomer, preferably consists of at least one elastomer.

17. The base body (5) comprises a first concave grip (37.1) and a second concave grip (37.2). The first concave grip (37.1) and the second concave grip (37.2) are formed on a side surface of the base body (5), preferably. The first concave grip (37.1) and the second concave grip (37.2) are arranged opposite to each other, preferably. The closure (1) according to claim 9, wherein the first concave grip (37.1) and the second concave grip (37.2) are formed at a lower part (21.2) of the base body (5).

18. The base body (5) comprises at least one recess (27). The sealing element (7) comprises at least one anchor element (29). The closure (1) according to claim 9, wherein the sealing element (7) is arranged on the base body (5) such that the at least one anchor element (29) engages within the at least one recess (27) and preferably projects from the at least one recess (27), preferably in an axial and / or radial direction.

19. A hollow medical body (3) comprising the closure (1) according to any one of claims 1 to 4.

20. A method for manufacturing the closure (1) according to claim 9, wherein the base body (5), the sealing element (7), and preferably the engaging element (9) are manufactured by a two-component injection molding process.

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