WO2023067085A1 - Verschluss für einen medizinischen hohlkörper, medizinischer hohlkörper mit einem solchen verschluss und verfahren zur herstellung eines solchen verschlusses - Google Patents
Verschluss für einen medizinischen hohlkörper, medizinischer hohlkörper mit einem solchen verschluss und verfahren zur herstellung eines solchen verschlusses Download PDFInfo
- Publication number
- WO2023067085A1 WO2023067085A1 PCT/EP2022/079252 EP2022079252W WO2023067085A1 WO 2023067085 A1 WO2023067085 A1 WO 2023067085A1 EP 2022079252 W EP2022079252 W EP 2022079252W WO 2023067085 A1 WO2023067085 A1 WO 2023067085A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- closure
- hollow body
- medical hollow
- base body
- engagement element
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1412—Containers with closing means, e.g. caps
- A61J1/1418—Threaded type
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D41/00—Caps, e.g. crown caps or crown seals, i.e. members having parts arranged for engagement with the external periphery of a neck or wall defining a pouring opening or discharge aperture; Protective cap-like covers for closure members, e.g. decorative covers of metal foil or paper
- B65D41/02—Caps or cap-like covers without lines of weakness, tearing strips, tags, or like opening or removal devices
- B65D41/16—Snap-on caps or cap-like covers
- B65D41/165—Snap-on caps or cap-like covers with integral internal sealing means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
- A61M2005/3104—Caps for syringes without needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
- A61M2005/3106—Plugs for syringes without needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
Definitions
- the invention relates to a closure for a medical hollow body, a medical hollow body with such a closure and a method for producing such a closure.
- closures in particular for pre-filled medical hollow bodies, have at least one sealing element which is designed in such a way that it covers a distal opening of the medical hollow body in a sealing manner when the closure is arranged in a closing position on the medical hollow body.
- the disadvantage of this is that the sealing effect of such a closure can be reduced, in particular due to thermal expansion during a sterilization process and/or during transport or storage of the closed medical hollow body, in which case a sterile medical product is no longer guaranteed.
- the invention is therefore based on the object of creating a closure for a medical hollow body, a medical hollow body with such a closure and a method for producing such a closure, the disadvantages mentioned being at least partially eliminated, preferably avoided.
- the object is achieved in particular by creating a closure for a medical hollow body, the closure having an engagement element, the engagement element having a sealing lip running in the circumferential direction, which is arranged on the engagement element in such a way that the sealing lip is on an end face of a distal opening one medical hollow body comes to rest when the closure is arranged on the medical hollow body in a closed position.
- the sealing lip thus advantageously forms a seal between the interior of the medical hollow body, in particular the product, and the exterior of the medical hollow body.
- the sealing lip enables the closure to be adequately sealed, in particular even when the contact pressure is reduced due to a sterilization process and/or transport or storage of the closed medical hollow product, so that a sterile medical product is ensured.
- the sealing lip it is advantageously possible by means of the sealing lip to realize the tightness of the medical hollow body when the closure is arranged on the medical hollow body in the closed position even if the contact pressure of the engagement element on the end face of the distal opening of the medical hollow body is reduced.
- the contact pressure can be reduced as a result of environmental influences and/or during a sterilization process.
- the engagement element has an underside, the underside of the end face at least partially facing the distal opening of the medical hollow body when the closure is arranged on the medical hollow body in the closed position.
- the sealing lip is arranged in particular on the underside of the engagement element. The sealing lip thus at least partially faces the end face of the distal opening of the medical hollow body when the closure is arranged on the medical hollow body in the closed position.
- the engagement element also has an engagement projection that is in particular conical in shape, wherein the engagement projection engages in the distal opening of the medical hollow body when the closure is arranged on the medical hollow body in the closed position.
- the engagement element is designed in such a way that it engages in the distal opening of the medical hollow body at least in certain areas - in particular with the in particular conically shaped engagement projection - when the closure is arranged on the medical hollow body in the closed position.
- the engagement element has at least one first groove, one of the at least one first groove associated groove direction is aligned with the arrangement of the closure on the medical hollow body in the closed position along an axial direction of the medical hollow body.
- the first groove is formed on the engagement projection.
- the engagement projection is free from the first groove.
- the engagement projection has no groove.
- the groove direction associated with a groove is a direction of a straight line extending from a start point of the groove to an end point of the groove, the start point of the groove and the end point of the groove preferably being spaced apart along the longest extent of the groove are.
- the groove direction is aligned along the axial direction of the medical hollow body when the groove direction and the axial direction of the medical hollow body enclose an angle of less than 90°, preferably an angle of less than or equal to 45°.
- the closure in particular the engagement element, advantageously closes the medical hollow body in a sealing manner when the closure is arranged on the medical hollow body in the closed position.
- the engagement element is advantageously in contact with a product present in the medical hollow body, in particular in fluidic contact, when the closure is arranged on the medical hollow body in the closed position.
- the groove forms a fluidic connection between an interior of the medical lumen and an exterior of the medical lumen when the closure is released from the closed position and preferably the engagement member is still engaging the distal opening of the medical lumen.
- a slower pressure compensation is advantageously possible in comparison to the known closures. This can advantageously at least reduce the formation of drops at the distal opening of the medical hollow body, as a result of which a reduction in the product present in the medical hollow body can be reduced.
- the engagement element is preferably designed in such a way that it sealingly abuts or rests on an end face of the distal region of the medical hollow body when the closure is on the medical hollow body is arranged in its closed position.
- the end face of the distal area is in particular an end face of the distal opening.
- the part of the engagement element that engages in the distal opening of the medical hollow body preferably lies sealingly on the medical hollow body, in particular on an inner wall of the medical hollow body, at least in regions, in particular outside the first groove.
- the axial direction of the medical hollow body preferably extends along a direction of the longest extent of the medical hollow body, preferably along an axis of symmetry of the preferably rotationally symmetrical medical hollow body.
- a radial direction is perpendicular to the axial direction.
- a circumferential direction encompasses the axial direction concentrically.
- the medical hollow body is preferably designed as a syringe.
- the product present in the medical hollow body is preferably a medical or pharmaceutical product, in particular a medical or pharmaceutical liquid.
- the at least one first groove runs in a straight line and has a groove longitudinal extension as the groove direction.
- the longitudinal extension of the groove and the axial direction of the medical hollow body preferably enclose an angle of 0° to 25°.
- the longitudinal extent of the groove and the axial direction of the medical hollow body are preferably aligned parallel to one another when the closure is arranged on the medical hollow body in the closed position.
- the at least one first groove is formed along a spatial curve, in particular a helical line or a conical spiral.
- the spatial curve extends along a winding axis.
- the winding axis of the at least one first groove and the axial direction of the medical hollow body are preferably parallel to one another when the closure is arranged on the medical hollow body in the closed position.
- the groove direction of the at least one first groove is determined using a start point of the spatial curve and an end point of the spatial curve.
- the groove direction of the at least one first groove, which extends along the spatial curve, and the axial direction of the medical hollow body when the closure is arranged on the medical hollow body in the closed position close an angle of less than 90°, particularly preferably less than or equal to 45°, a.
- the first groove designed as a conical spiral, preferably has a pitch of 0.5 mm to 2 mm, preferably 1 mm.
- the spiral-shaped first groove has at least one turn, preferably from 1 turn to 3 turns, particularly preferably 1.75 turns.
- the spiral-shaped first groove tapers from 0° to 45°, preferably 20°.
- a groove width of the first groove tapers from 0° to 45°, preferably 20°.
- the engagement element - in particular the in particular conical engagement projection - has at least one second groove which extends in a plane, with a normal direction of the plane when the closure is arranged on the medical hollow body in the closed position and the Include an angle of 0 ° to 18 ° axial direction of the medical hollow body.
- the normal direction of the plane and the longitudinal extension of the first groove are preferably aligned parallel to one another.
- the normal direction of the plane when the closure is arranged on the medical hollow body in the closed position and the axial direction of the medical hollow body are preferably aligned parallel to one another.
- gas is advantageously guided from the interior of the medical hollow body to the second groove by means of the first groove, regardless of the manner in which - particularly in in which direction or at which angle in relation to the axial direction of the medical hollow body - the closure is released from the closed position, wherein in particular the second groove comes into flow communication with the exterior of the medical hollow body.
- a slower pressure equalization is possible in comparison to the known closures.
- the closure has a sealing element.
- the sealing element is designed in such a way that it is in sealing contact with at least one distal area of the medical hollow body when the closure is arranged on the medical hollow body in a closed position.
- the sealing element is advantageously not in contact with the product present in the medical hollow body when the closure is arranged on the medical hollow body in the closed position, in particular if the sealing element and the engagement element are designed in two parts.
- the sealing element is designed in such a way that it encompasses at least the distal area of the medical hollow body in a sealing manner when the closure is arranged on the medical hollow body in the closed position.
- the sealing element and the engagement element are formed in one piece, preferably of the same material. It is thus advantageously possible to manufacture the sealing element and the engagement element in one process step, saving time and money.
- the sealing element and the engagement element are designed in two parts.
- the engagement element is accommodated at least in regions in the sealing element, in particular in a recess of the sealing element provided for this purpose.
- the sealing element encompasses the engagement element in the circumferential direction.
- the material of the engagement element on the basis of permanent contact in particular with the product present in the medical hollow body, in particular during transport and/or storage, in such a way that the material is stable, in particular chemically stable, towards the product and preferably does not migrate into the product.
- the closure has a base body.
- the engagement element is at least partially arranged within the base body.
- the sealing element is at least partially arranged within the base body.
- the base body is advantageously not in contact with the product present in the medical hollow body when the closure is arranged on the medical hollow body in the closed position.
- the base body preferably encloses the sealing element and the engagement element.
- the sealing element is particularly preferably arranged in the base body in such a way that it is in sealing contact with at least the distal area of the medical hollow body when the closure is arranged on the medical hollow body in a closed position.
- the engagement element is particularly preferably arranged in the base body in such a way that it engages in a distal opening of the medical hollow body at least in certain areas - in particular with the in particular conical engagement projection - when the closure is arranged on the medical hollow body in the closed position.
- the base body has an internal thread.
- the internal thread engages around a distal area of the medical hollow body when the closure is arranged on the medical hollow body in the closed position.
- the thread is preferably a Luer thread.
- the sealing element and the engagement element are arranged in the base body in such a way that they are spaced apart from one another in at least a first area along the longitudinal extension of the groove, and come to rest on one another in at least a second area.
- a position of the engagement element relative to the sealing element and the base body is advantageously fixed by means of the at least one second region.
- the second region advantageously serves to hold down the engagement element and preferably to press it onto the distal opening of the medical hollow body.
- the second area is preferably designed in such a way that manufacturing tolerances of at least one element selected from a group consisting of the base body, the sealing element and the engagement element are compensated for.
- the at least one first region is a recess, in particular a cavity, between the engagement element and the sealing element.
- the at least one first area enables the engagement element to avoid an existing pressure when the closure is arranged on the medical hollow body in the closed position in the event of a press fit with the medical hollow body, in that the engagement element is at least partially in the at least one first Area is shifted, and the engagement element is thus at least only partially compressed.
- the base body has an upper part and a lower part, with the lower part preferably having the internal thread.
- the upper part and the lower part are connected to one another by means of a plurality of webs.
- the internal thread, in particular the Luer thread, and the base body, in particular the lower part, are preferably designed in two parts.
- the internal thread, in particular the Luer thread, and the base body, in particular the lower part, are preferably formed in one piece.
- the upper part and the lower part are designed in such a way that, while the closure is being released from the closed position, the upper part and the lower part are in particular irreversibly separated from one another, with the lower part being attached to the medical Hollow body remains arranged.
- the upper part, the sealing element and the engaging element are connected to one another in such a way that while the closure is released from the closed position, the sealing element and the engaging element are also separated from the medical hollow body together with the upper part.
- An axial direction of the upper part, an axial direction of the lower part and the axial direction of the medical hollow body are preferably aligned parallel to one another, in particular identically, in a closed position.
- the closure is particularly preferably released from the closed position by tilting the upper part relative to the axial direction of the medical hollow body and thus in particular relative to the axial direction of the lower part in an opening direction orthogonal to the axial direction of the lower part, so that at least one web of the plurality of webs is stretched and at least one web of the plurality of webs is squeezed.
- all webs of the plurality of webs are irreversibly destroyed during the tilting, so that the upper part and the lower part can be separated from one another.
- the opening direction is particularly preferably aligned opposite a groove opening direction of the first groove.
- the slot opening direction is aligned orthogonally to a plane in which the slot is introduced.
- the groove opening direction is oriented orthogonal to the groove length.
- the upper part and the lower part of the base body are preferably connected by means of a maximum of eight webs.
- the base body has the upper part, the lower part and the plurality of webs connecting the upper part and the lower part.
- the engagement element has the sealing lip.
- the sealing lip makes it possible to reduce the contact pressure of the engagement element on the end face of the distal opening of the medical hollow body. Tension of the webs can thus advantageously be reduced, as a result of which deformation of the webs during heating—in particular during sterilization of the medical hollow body closed with the closure—can advantageously be reduced.
- the closure has a holding element which is arranged on the base body in such a way that it preferably encompasses the medical hollow body in a form-fitting and/or non-positive manner when the closure is arranged on the medical hollow body in the closed position.
- the holding element has at least one anti-rotation section, which engages in a recess of the base body, in particular the lower part of the base body.
- the holding element allows the lower part to remain arranged on the medical hollow body while the closure is released from the closed position.
- the anti-rotation section fixes the base body of the closure to the holding element in a manner that prevents it from rotating.
- the holding element is preferably arranged on the base body before the closure is arranged in the closed position on the medical hollow body.
- the retaining element is particularly preferably latched to the base body before the closure is arranged in the closed position on the medical hollow body.
- the holding element and the plurality of webs advantageously interact in such a way that while the closure is released from the closed position, the upper part and the lower part are in particular irreversibly separated from one another and the lower part remains arranged on the medical hollow body.
- the base body and the sealing element are produced by means of a two-component injection molding process.
- the base body, the sealing element and the engaging element are produced by means of a multi-component injection molding process, in particular the two-component injection molding process.
- the sealing element has at least one thermoplastic elastomer (TPE).
- the sealing element consists of at least one thermoplastic elastomer (TPE).
- thermoplastic elastomer can advantageously be processed in a simple manner by means of an injection molding process.
- the engagement element has at least one elastomer.
- the engagement element consists of at least one elastomer.
- elastomers are stable, in particular chemically stable, with respect to a large number of products that can be present inside the medical hollow body.
- a good seal between the interior and the exterior of the medical hollow body can advantageously be realized with an engagement element made of at least one elastomer.
- the engagement element preferably has at least one rubber material.
- the engagement element preferably consists of at least one rubber material.
- the at least one elastomer is preferably a vulcanizate of a rubber.
- the at least one elastomer is particularly preferably a vulcanizate of a silicone rubber.
- the at least one elastomer is preferably selected from a group consisting of a halogenated butyl rubber, in particular a bromobutyl rubber, a chlorobutyl rubber, a polyisoprene rubber, a polybutadiene rubber, an ethylene-propylene copolymer rubber, an ethylene-propylene-diene copolymer rubber, a chlorosulfonated polyethylene rubber, an ethylene-vinyl acetate copolymer rubber, a styrene-isoprene copolymer rubber, a fluoroelastomer rubber, a perfluoroelastomer rubber, a tetrafluoroethylene rubber, a propylene rubber, a butyl rubber, an
- the engagement element which has at least one elastomer, in particular at least one rubber material, or consists of at least one elastomer, in particular at least one rubber material, and in particular the sealing lip, prevents the contents of the medical hollow body from coming into contact with the sealing element and thus possibly with a less suitable material comes into primary contact.
- the engagement element which consists of a material different from the material of the sealing element, ensures that the contents of the medical hollow body do not come into primary contact with a thermoplastic elastomer.
- the engagement element and the sealing element are designed in one piece and of the same material.
- the engagement element and the sealing element preferably have at least one thermoplastic elastomer (TPE).
- TPE thermoplastic elastomer
- the engagement element and the sealing element consist of at least one thermoplastic elastomer (TPE).
- the engagement element and the sealing element preferably have at least one elastomer, in particular at least one rubber material.
- the engagement element and the sealing element consist of at least one elastomer, in particular at least one rubber material.
- the engagement element and the sealing element are designed in one piece.
- the sealing element is preferably injection molded onto the engagement element.
- the engagement element and the sealing element are fused together.
- the sealing element preferably has at least one thermoplastic elastomer (TPE).
- TPE thermoplastic elastomer
- the sealing element consists of at least one thermoplastic elastomer (TPE).
- the engagement element preferably has at least one elastomer, in particular at least one rubber material.
- the engagement element consists of at least one elastomer, in particular at least one rubber material.
- the base body has a first recessed grip and a second recessed grip, the first recessed grip and the second recessed grip being formed on a lateral surface of the base body.
- the first recessed grip and the second recessed grip are preferably arranged diametrically opposite one another.
- the first recessed grip and the second recessed grip are preferably formed on the lower part of the base body.
- the recessed grips it is possible by means of the recessed grips to grip the closure in a simple manner and in particular to hold the lower part in order to place the closure on a medical
- the recessed grips also improve the optical and haptic impression and the ergonomics of the closure.
- the base body has at least one recess.
- the sealing element has at least one anchoring element, the sealing element being arranged in the base body in such a way that the at least one anchoring element engages in the at least one recess.
- the at least one anchoring element is preferably designed in such a way that it protrudes from the at least one recess in an axial direction—in particular in the axial direction of the base body.
- the at least one anchoring element is preferably designed in such a way that it protrudes from the at least one recess in a radial direction—in particular in a radial direction of the base body.
- the at least one recess is particularly preferably formed on the upper part of the base body.
- the at least one anchoring element which protrudes from the at least one recess, it is possible to grip the closure in a simple manner and in particular to hold the upper part firmly in order to arrange the closure on a medical hollow body in the closed position or to remove the lower part and the upper part of the Main body to separate in particular irreversible when opening the closure.
- the at least one recess and the at least one anchoring element are preferably arrow-shaped, so that the preferred opening direction of the closure can be represented by means of the at least one recess and the at least one anchoring element.
- the object is also achieved by creating a medical hollow body with a closure according to the invention or a closure according to one or more of the embodiments described above. In connection with the medical hollow body, there are in particular the advantages that have already been explained in connection with the closure.
- the object is also achieved by creating a method for producing a closure according to the invention or a closure according to one or more of the embodiments described above, the base body and the sealing element being produced using a two-component injection molding process.
- the base body, the sealing element and the engaging element are preferably produced by means of the two-component injection molding process or the multi-component injection molding process.
- the closure according to the invention or a closure according to one or more of the embodiments described above is obtained.
- FIG. 1 shows a schematic representation of a first exemplary embodiment of a closure
- FIG. 3 shows a schematic representation of a third embodiment of the closure
- FIG. 4 shows a schematic representation of a fourth exemplary embodiment of the closure
- FIG. 5 shows a schematic representation of a fifth exemplary embodiment of the closure
- FIG. 6 shows a schematic representation of a sixth embodiment of the closure
- FIG. 7 shows a schematic representation of a seventh exemplary embodiment of the closure
- Fig. 8 is a schematic representation of a first embodiment of the medical
- FIG. 9 shows a schematic representation of a second exemplary embodiment of the medical hollow body, 10 shows a schematic sectional illustration of an eighth exemplary embodiment of the closure,
- Fig. 11 is a flow chart of a first embodiment of a method for
- Fig. 12 is a flow chart of a second embodiment of the method for
- Figure 1 shows a schematic representation of a first embodiment of a closure 1.
- the closure 1 has an engagement element 9 with a sealing lip 31 running in the circumferential direction.
- the sealing lip 31 is formed on the engagement element 9 and arranged in such a way that the sealing lip 31 comes to rest on an end face 33 of a distal opening 13 of a medical hollow body 3 when the closure 1 is arranged on the medical hollow body 3 in a closed position.
- Figure 2 shows a schematic representation of a second embodiment of the closure 1.
- the closure 1 has the engagement element 9, which is preferably designed in such a way that it engages at least in certain areas - in particular with an engagement projection 10 - in the distal opening 13 of the medical hollow body 3 when the closure 1 is arranged on the medical hollow body 3 in the closed position is.
- the engagement element 9 particularly preferably has—in particular on the engagement projection 10—at least one first groove 15.1 with a groove direction 16 assigned to the at least one first groove 15.1.
- the groove direction 16 is aligned along an axial direction 19 of the medical hollow body 3 .
- the at least one first groove 15.1 preferably runs in a straight line and has a groove longitudinal extension 17 as the groove direction 16.
- the longitudinal extension 17 of the groove and the axial direction 19 of the medical hollow body 3 particularly preferably enclose an angle of 0° to 25°, in particular 21°, when the closure 1 is arranged on the medical hollow body 3 in the closed position.
- the longitudinal extension 17 of the groove and the axial direction 19 are aligned parallel to one another; in particular, they preferably coincide.
- the engagement element 9 additionally has at least one second groove 15.2, in particular on the engagement projection 10, which extends in a plane, with a normal direction of the plane being aligned along the longitudinal extent 17 of the first groove 15.1.
- the normal direction of the plane and the longitudinal extension 17 of the groove are particularly preferably aligned parallel to one another.
- Figure 3 shows a schematic representation of a third embodiment of the closure 1 with the engagement element 9.
- the first groove 15.1 in which the longitudinal extension 17 of the groove and the axial direction 19 in particular enclose a positive angle, the second groove 15.2, and the sealing lip 31 running in the circumferential direction can be clearly seen.
- Figure 4 shows a schematic representation of a fourth embodiment of the closure 1.
- the engagement element 9 has the sealing lip 31 .
- the sealing lip 31 is formed on the engagement element 9 and arranged in such a way that the sealing lip 31 comes to rest on the end face 33 of the distal opening 13 of the medical hollow body 3 when the closure 1 is arranged on the medical hollow body 3 in the closed position.
- the closure 1 has, in particular, a sealing element 7 in addition to the engagement element 9 .
- the sealing element 7 is designed in such a way that it is attached at least to a distal area 11 of the medical hollow body 3 rests sealingly when the closure 1 is arranged on the medical hollow body 3 in the closed position.
- the sealing element 7 and the engagement element 9 are designed in one piece, in particular of the same material.
- FIG. 5 shows a schematic representation of a fifth exemplary embodiment of the closure 1 for a medical hollow body 3.
- the closure 1 has a base body 5, the sealing element 7 and the engagement element 9.
- the sealing element 7 is arranged in the base body 5 in such a way that it is in sealing contact with at least the distal area 11 of the medical hollow body 3 when the closure 1 is arranged on the medical hollow body 3 in the closed position.
- the engagement element 9 has the sealing lip 31 running in the circumferential direction.
- the sealing lip 31 is formed on the engagement element 9 and arranged in such a way that the sealing lip 31 comes to rest on the end face 33 of the distal opening 13 of the medical hollow body 3 when the closure 1 is arranged on the medical hollow body 3 in the closed position.
- the base body 5 preferably encompasses the sealing element 7 and the engagement element 9 at least partially.
- the base body particularly preferably has an upper part 21.1 and a lower part 21.2.
- the upper part 21.1 and the lower part 21.2 are preferably connected to one another by means of a plurality of webs 23.
- the sealing element 7 and the engagement element 9 are formed in one piece, in particular of the same material, with one another.
- the base body 5, in particular the lower part 21.2 of the base body 5, preferably has an internal thread 25 which encompasses the distal region 11 of the medical hollow body 3 when the closure 1 is arranged on the medical hollow body 3 in the closed position.
- the internal thread 25 is particularly preferably designed as a Luer thread.
- the internal thread 25, in particular the Luer thread, and the base body 5, in particular the lower part 21.2 are preferably designed in two parts. alternative are preferably the internal thread 25, in particular the Luer thread, and the base body 5, in particular the lower part 21.2, are designed in one piece.
- the base body 5, in particular the upper part 21.1 of the base body 5, preferably has at least one recess 27.
- the sealing element 7 preferably has at least one anchoring element 29 , the sealing element 7 being arranged in the base body 5 in such a way that the at least one anchoring element 29 engages in the at least one recess 27 .
- the sealing element 7 preferably has at least one thermoplastic elastomer (TPE).
- the sealing element 7 particularly preferably consists of at least one thermoplastic elastomer (TPE).
- Figure 6 shows a schematic representation of a sixth embodiment of the closure 1 for the medical hollow body 3.
- the sixth exemplary embodiment of the closure 1 is, in addition to the fifth exemplary embodiment of the closure 1 from Figure 5, designed and arranged in the base body 5 in such a way that it fits at least in certain areas - in particular with the in particular conical engagement projection 10 - into the distal opening 13 of the medical hollow body 3 engages when the closure 1 is placed on the medical hollow body 3. Furthermore, the engagement element 9 - in particular the in particular conical engagement projection 10 - has at least the first groove 15.1 with the groove longitudinal extent 17.
- the longitudinal extent of the groove 17 is aligned along the axial direction 19 of the medical hollow body 3; in particular, the longitudinal extent of the groove 17 when the closure 1 is arranged on the medical hollow body 3 in the closed position and the axial direction 19 of the medical hollow body 3 is aligned parallel to one another.
- the engagement element 9 - in particular the particularly conical engagement projection 10 - has at least one second groove 15.2, which extends in a plane, with a normal direction of the plane being aligned along the longitudinal extent of the groove.
- the normal direction of the plane and the longitudinal extent of the groove are particularly preferably aligned parallel to one another.
- Figure 7 shows a schematic representation of a seventh embodiment of the closure 1.
- the closure 1 preferably has a separate holding element 35 .
- the holding element 35 is preferably arranged on the base body 5 of the closure 1 in such a way that it encloses the medical hollow body 3 in a positive and/or non-positive manner when the closure 1 is arranged on the medical hollow body 3 in the closed position.
- the base body 5, in particular the upper part 21.1 of the base body 5, preferably has a plurality of recesses 27, in particular seven recesses 27.
- the sealing element 7 has a plurality of anchoring elements 29, in particular seven anchoring elements 29, in particular the number of recesses is 27 and the number of anchoring elements 29 identical.
- At least one anchoring element 29 of the plurality of anchoring elements 29 is preferably designed as a radial anchoring element 29.1, in particular the sealing element 7 has six radial anchoring elements 29.1, which protrude from the respective recess 27 in a radial direction.
- At least one anchoring element 29 of the plurality of anchoring elements 29 is preferably designed as an axial anchoring element 29.2, in particular the sealing element 7 has an axial anchoring element 29.2 which protrudes from the associated recess 27 in an axial direction.
- the sealing element 7 has an axial anchoring element 29.2 which protrudes from the associated recess 27 in an axial direction.
- only one radial anchoring element 29.1 and the axial anchoring element 29.2 with the respective associated recesses 27 are provided with reference symbols.
- the base body 5, in particular the lower part 21.2 of the base body 5, preferably has a first recessed grip 37.1 and a second recessed grip 37.2, the first recessed grip 37.1 and the second recessed grip 37.2 being formed on a lateral surface of the base body 5.
- the first recessed grip 37.1 and the second recessed grip 37.2 are particularly preferably arranged diametrically opposite one another.
- the sealing element 7 and the engagement element 9 are designed in two parts.
- the sealing element 7 preferably has at least one thermoplastic elastomer (TPE). Alternatively, the sealing element 7 particularly preferably consists of at least one thermoplastic elastomer (TPE).
- the engagement element 9 preferably has at least one elastomer, in particular at least one rubber. Alternatively, the engagement element 9 particularly preferably consists of at least one elastomer, in particular at least one rubber.
- the sealing element 7 and the engagement element 9 are particularly preferably designed and arranged in such a way that they are spaced apart from one another in at least a first region 39.1 in the direction of the longitudinal extension 17 of the groove.
- the sealing element 7 and the engagement element 9 preferably come to rest on one another in at least a second region 39.2—in a punctiform or planar manner.
- the second area 39.2 serves in particular as a spring element, which pushes the engagement element 9 against the end face 33 of the medical hollow body 3 in the closed position.
- FIG. 8 shows a schematic representation of a first exemplary embodiment of a medical hollow body 3 with the closure 1, which is arranged on the medical hollow body 3 in the closed position.
- Figure 8 a) shows a first view
- Figure 8 b) shows a second view of the medical hollow body 3, the second view being obtained from the first view by rotating the medical hollow body 3 by preferably 90° about the axial direction 19 when the first Nut 15.1 is rotated backwards into the image plane.
- the sealing element 7 and the engagement element 9 are preferably formed in two parts, with the engagement element 9 particularly preferably having the first groove 15.1, the second groove 15.2 and the sealing lip 31.
- one of the recesses 27 can be seen on an end face of the base body 5, with the axial anchoring element 29.2, which is formed in particular on the sealing element 7, protruding from the recess 27 in the axial direction 19.
- each recess 27 of the six recesses 27 can be seen on the lateral surface of the base body 5, in particular on the lateral surface of the upper part 21.1 of the base body 5, with each recess 27 of the six recesses 27 being fitted with a radial anchoring element 29 engages and protrudes radially.
- a radial anchoring element 29.1 and the associated recess 27 are provided with reference symbols.
- the first groove 15.1 of the engagement element 9 is not visible in FIG. 8 b) due to the rotated view.
- first recessed grip 37.1 and the second recessed grip 37.2 are not visible in FIG. 8b).
- FIG. 8a A comparison of the two views from FIG. 8a) and FIG. 8b) shows that both the radial anchoring elements 29.1 and the first recessed grip 37.1 and the second recessed grip 37.2 are only partially formed in the circumferential direction.
- Figure 9 shows a schematic representation of a second embodiment of the medical hollow body 3 with the closure 1.
- FIG. 9 shows an external view of the medical hollow body 3 with the closure 1. It is therefore possible for the sealing element 7 and the engagement element 9 to be designed in one piece with one another. Alternatively, however, it is also possible for the sealing element 7 and the engagement element 9 to be designed in two parts.
- the axial anchoring element 29.2 is preferably in the form of an arrow in order to advantageously indicate a particularly preferred opening direction.
- the radial anchoring elements 29.1 are preferably only formed in certain areas along the circumferential direction of the lateral surface of the upper part 21.1 of the base body 5.
- the first recessed grip 37.1 is formed only in certain areas along the circumferential direction of the lateral surface of the lower part 21.2 of the base body 5.
- the radial anchoring elements 29.1, the first recessed grip 37.1 and the second recessed grip 37.2 are preferably designed in such a way that the closure 1 can be gripped easily and securely.
- FIG. 10 shows a schematic sectional illustration of an eighth exemplary embodiment of the closure 1 with the holding element 35, which is arranged in particular on an underside of the lower part 21.2 of the base body 5.
- the holding element 35 preferably has an anti-rotation section 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.
- the holding element 35 is inserted into the base body 5, in particular into the lower part 21.2 of the base body 5--inserted from the left in the illustrated figure.
- the holding element 35 preferably has a clamping geometry, in particular a plurality of teeth 45, which is designed and arranged in such a way that the medical hollow body 3, in particular the distal region 11 of the medical hollow body 3, can be gripped in a positive and/or non-positive manner.
- An inner diameter 47 of the holding element 35 is particularly preferably smaller than a diameter of the distal area 11 of the medical hollow body 3 on which the closure 1 is arranged. Due to the plurality of teeth 45, the holding element 35 is flexible in some areas, so that the closure 1 can be arranged on the medical hollow body 3 in the closed position.
- the retaining element 35 is particularly preferably latched to the base body 5 before the closure 1 is arranged on the medical hollow body 3 in the closed position.
- Figure 11 shows a flow chart of a first exemplary embodiment of a method for producing the closure 1.
- the base body 5 and the sealing element 7 are produced by means of a two-component injection molding process.
- the sealing element 7 is preferably made of at least one thermoplastic elastomer.
- the engagement element 9 is preferably made from at least one elastomer.
- the at least one elastomer is preferably a vulcanizate of a rubber and/or a vulcanizate of a silicone rubber.
- a second step b the engagement element 9 is arranged in the base body 5 and the sealing element 7, with the closure 1 being produced.
- the holding element 35 is preferably arranged on the base body 5 .
- the holding element 35 is particularly preferably connected to the base body 5 in that the at least one anti-rotation section 41 engages in the at least one recess 43 of the base body 5 .
- the closure 1 is preferably arranged in the closure position on the medical hollow body 3 .
- FIG. 12 shows a flow chart of a second exemplary embodiment of a method for producing the closure 1.
- the base body 5, the sealing element 7 and the engagement element 9 are produced by means of a two-component injection molding method or a multi-component injection molding method. wherein the sealing member 7 and the engaging member 9 are integrally formed with each other.
- the one-piece design of the sealing element 7 and the engagement element 9 is preferably made from at least one thermoplastic elastomer.
- the closure 1 is thus produced in a single step, in particular the first step a).
- the holding element 35 is preferably arranged on the base body 5 .
- the holding element 35 is particularly preferably connected to the base body 5 in that the at least one anti-rotation section 41 engages in at least one recess 43 of the base body 5 .
- the closure 1 is preferably arranged in the closure position on the medical hollow body 3 .
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Vascular Medicine (AREA)
- Mechanical Engineering (AREA)
- Pharmacology & Pharmacy (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- External Artificial Organs (AREA)
- Closures For Containers (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Priority Applications (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA3234807A CA3234807A1 (en) | 2021-10-21 | 2022-10-20 | Closure piece for a medical hollow body, medical hollow body having such a closure piece, and method for producing such a closure piece |
| JP2024523616A JP2024537432A (ja) | 2021-10-21 | 2022-10-20 | 中空医療用本体のためのクロージャ、そのようなクロージャを有する中空医療用本体およびそのようなクロージャの製造方法 |
| MX2024004784A MX2024004784A (es) | 2021-10-21 | 2022-10-20 | Cierre para un cuerpo hueco medicinal, cuerpo hueco medicinal teniendo semejante cierre y metodo para la produccion de semejante cierre. |
| EP22809649.1A EP4419174A1 (de) | 2021-10-21 | 2022-10-20 | Verschluss für einen medizinischen hohlkörper, medizinischer hohlkörper mit einem solchen verschluss und verfahren zur herstellung eines solchen verschlusses |
| US18/703,014 US20240416043A1 (en) | 2021-10-21 | 2022-10-20 | Closure piece for a medical hollow body, medical hollow body having such a closure piece, and method for producing such a closure piece |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102021127437.0A DE102021127437A1 (de) | 2021-10-21 | 2021-10-21 | Verschluss für einen medizinischen Hohlkörper, medizinischer Hohlkörper mit einem solchen Verschluss und Verfahren zur Herstellung eines solchen Verschlusses |
| DE102021127437.0 | 2021-10-21 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2023067085A1 true WO2023067085A1 (de) | 2023-04-27 |
Family
ID=84361896
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/EP2022/079252 Ceased WO2023067085A1 (de) | 2021-10-21 | 2022-10-20 | Verschluss für einen medizinischen hohlkörper, medizinischer hohlkörper mit einem solchen verschluss und verfahren zur herstellung eines solchen verschlusses |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US20240416043A1 (enExample) |
| EP (1) | EP4419174A1 (enExample) |
| JP (1) | JP2024537432A (enExample) |
| CA (1) | CA3234807A1 (enExample) |
| DE (1) | DE102021127437A1 (enExample) |
| MX (1) | MX2024004784A (enExample) |
| WO (1) | WO2023067085A1 (enExample) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102021127435A1 (de) * | 2021-10-21 | 2023-04-27 | Vetter Pharma-Fertigung GmbH & Co. KG | Verschluss für einen medizinischen Hohlkörper, medizinischer Hohlkörper mit einem solchen Verschluss und Verfahren zur Herstellung eines solchen Verschlusses |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060178627A1 (en) * | 2004-05-29 | 2006-08-10 | Bünder Glas GmbH | Syringe tip cap and method for producing a syringe tip cap |
| US20150238703A1 (en) * | 2012-11-09 | 2015-08-27 | Vetter Pharma-Fertigung GmbH & Co. KG | Syringe Closure |
| US20160030284A1 (en) * | 2014-08-04 | 2016-02-04 | Genentech, Inc. | Apparatus and methods for sealing a medicament within a medical delivery device |
| US20200030552A1 (en) * | 2017-04-04 | 2020-01-30 | Nipro Corporation | Syringe type ejection device |
| WO2021014274A1 (en) * | 2019-07-24 | 2021-01-28 | 3M Innovative Properties Company | Cleaning cap for medical implement |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2604252Y2 (ja) * | 1993-09-30 | 2000-04-24 | 株式会社吉野工業所 | 容 器 |
| WO2001014242A1 (de) | 1999-08-20 | 2001-03-01 | Kurt Oberhofer | Verschluss für die befüllöffnung eines flüssigkeitsbehälters |
| JP5325549B2 (ja) * | 2007-12-21 | 2013-10-23 | 三笠産業株式会社 | 合成樹脂製の栓 |
| DE102011013792A1 (de) | 2011-03-03 | 2012-09-06 | Vetter Pharma-Fertigung GmbH & Co. KG | Verschluss für eine Pulverspritze und Pulverspritze |
| DE102011013791A1 (de) | 2011-03-03 | 2012-09-06 | Vetter Pharma-Fertigung GmbH & Co. KG | Verschluss und Verfahren zur Herstellung eines Verschlusses |
| JP6109496B2 (ja) * | 2012-06-19 | 2017-04-05 | 株式会社Trホールディングス | キャップ付き容器 |
| JP2016155571A (ja) * | 2015-02-25 | 2016-09-01 | 興和株式会社 | 塗布容器と、それを使用する医薬 |
| DE102019207970A1 (de) | 2019-05-29 | 2020-12-03 | Vetter Pharma-Fertigung GmbH & Co. KG | Medizinischer Hohlkörper, medizinischer Hohlkörper mit einer Verschlusskappe, Verfahren zum Herstellen eines medizinischen Hohlkörpers, und Kit |
| DE102021127435A1 (de) * | 2021-10-21 | 2023-04-27 | Vetter Pharma-Fertigung GmbH & Co. KG | Verschluss für einen medizinischen Hohlkörper, medizinischer Hohlkörper mit einem solchen Verschluss und Verfahren zur Herstellung eines solchen Verschlusses |
-
2021
- 2021-10-21 DE DE102021127437.0A patent/DE102021127437A1/de active Pending
-
2022
- 2022-10-20 MX MX2024004784A patent/MX2024004784A/es unknown
- 2022-10-20 JP JP2024523616A patent/JP2024537432A/ja active Pending
- 2022-10-20 WO PCT/EP2022/079252 patent/WO2023067085A1/de not_active Ceased
- 2022-10-20 US US18/703,014 patent/US20240416043A1/en active Pending
- 2022-10-20 EP EP22809649.1A patent/EP4419174A1/de active Pending
- 2022-10-20 CA CA3234807A patent/CA3234807A1/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060178627A1 (en) * | 2004-05-29 | 2006-08-10 | Bünder Glas GmbH | Syringe tip cap and method for producing a syringe tip cap |
| US20150238703A1 (en) * | 2012-11-09 | 2015-08-27 | Vetter Pharma-Fertigung GmbH & Co. KG | Syringe Closure |
| US20160030284A1 (en) * | 2014-08-04 | 2016-02-04 | Genentech, Inc. | Apparatus and methods for sealing a medicament within a medical delivery device |
| US20200030552A1 (en) * | 2017-04-04 | 2020-01-30 | Nipro Corporation | Syringe type ejection device |
| WO2021014274A1 (en) * | 2019-07-24 | 2021-01-28 | 3M Innovative Properties Company | Cleaning cap for medical implement |
Also Published As
| Publication number | Publication date |
|---|---|
| DE102021127437A1 (de) | 2023-04-27 |
| US20240416043A1 (en) | 2024-12-19 |
| CA3234807A1 (en) | 2023-04-27 |
| EP4419174A1 (de) | 2024-08-28 |
| JP2024537432A (ja) | 2024-10-10 |
| MX2024004784A (es) | 2024-05-09 |
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