EP4419173A1 - 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

Info

Publication number
EP4419173A1
EP4419173A1 EP22809003.1A EP22809003A EP4419173A1 EP 4419173 A1 EP4419173 A1 EP 4419173A1 EP 22809003 A EP22809003 A EP 22809003A EP 4419173 A1 EP4419173 A1 EP 4419173A1
Authority
EP
European Patent Office
Prior art keywords
closure
hollow body
medical hollow
groove
base body
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.)
Pending
Application number
EP22809003.1A
Other languages
German (de)
English (en)
French (fr)
Inventor
Petra Hund
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vetter Pharma Fertigung GmbH and Co KG
Original Assignee
Vetter Pharma Fertigung GmbH and Co KG
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Vetter Pharma Fertigung GmbH and Co KG filed Critical Vetter Pharma Fertigung GmbH and Co KG
Publication of EP4419173A1 publication Critical patent/EP4419173A1/de
Pending legal-status Critical Current

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
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • 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
    • 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
    • A61M2207/00—Methods of manufacture, assembly or production
    • 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
    • B65D41/32—Caps or cap-like covers with lines of weakness, tearing-strips, tags, or like opening or removal devices, e.g. to facilitate formation of pouring openings
    • B65D41/58—Caps or cap-like covers combined with stoppers

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.
  • a pressure difference can form between an interior of the medical hollow body and an exterior of the medical hollow body, in particular an overpressure in the interior of the medical hollow body. It is possible that this pressure difference, in particular this overpressure, develops as a result of a manufacturing process, in particular when a stopper and/or a piston rod is arranged, and/or a change in the air pressure during transport and/or storage of the prefilled medical hollow body.
  • Known closures for the in particular pre-filled hollow medical bodies have at least one sealing element which is designed in such a way that it covers a distal opening of the hollow medical body in a sealing manner when the closure is arranged in a closing position on the hollow medical body.
  • the disadvantage of this is that the drops spill out of the medical hollow body when it is opened, and the amount of product available for administration to a patient is therefore reduced. Furthermore, it is possible that the drop wets a thread and/or a cone of the medical hollow body, whereby a Adhesion between the thread or the cone and a device for applying the product of the medical hollow body adversely affected, in particular is reduced.
  • 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 is designed in such a way that it engages in a distal opening of the medical hollow body at least in certain areas--in particular with a 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, wherein a groove direction associated with the at least one first groove is aligned along an axial direction of the medical hollow body when the closure is arranged on the medical hollow body in the closed position.
  • the first groove is formed on the engagement projection.
  • 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 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 rests sealingly on an end face of the distal area of the medical hollow body when the closure is arranged on the medical hollow body 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 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 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.
  • 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 due to permanent contact in particular with the product present in the medical hollow body, in particular during transport and/or storage, such that the material is stable, in particular chemically stable, to the product and preferably not migrated into the product.
  • the engagement element has a sealing lip running in the circumferential direction, which is arranged on the engagement element in such a way that the sealing lip comes to rest on the end face of the distal opening of the medical hollow body when the closure is on the medical hollow body in the closing position is arranged.
  • the sealing lip thus forms a further seal, in particular in addition to the region of the Engagement element between the interior of the medical hollow body, in particular the product, and the outside of the medical hollow body.
  • the sealing lip is arranged 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 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 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 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. Due to the plurality of webs, it is advantageously possible in a simple manner to separate the upper part and the lower part from one another, in particular irreversibly. In particular, it is advantageously possible to reduce the force required to open the closure and at the same time to provide manipulation detection.
  • 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 remaining arranged on the medical hollow body.
  • 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 the 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 counter to a slot opening direction of the first slot.
  • the groove opening direction is aligned orthogonally to a plane in which the groove is introduced.
  • the groove opening direction is oriented orthogonal to the groove elongation.
  • 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 base body, the sealing element and preferably the engagement element in one process step in a time- and cost-saving manner.
  • an additional process step is omitted in order to connect the base body, the sealing element and preferably the engagement element to one another.
  • 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 is
  • 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, prevents the contents of the medical hollow body from coming into primary contact with the sealing element and thus possibly with a less suitable material comes.
  • 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 firmly in order to arrange the closure on a medical hollow body in the closed position or to separate the lower part and the upper part of the main body when the closure is opened, in particular irreversibly.
  • 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, to grip the closure in a simple manner and in particular to hold the upper part in place in order to place the closure on a medical
  • hollow body in the closed position or to separate the lower part and the upper part of the base body in particular irreversibly when the closure is opened.
  • 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.
  • a closure according to the invention or a closure according to one or more of the embodiments described above.
  • 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
  • 5 shows a schematic representation of a first exemplary embodiment of a medical hollow body
  • 6 shows a schematic representation of a fifth exemplary embodiment of the closure
  • FIG. 7 shows a schematic representation of a sixth embodiment of the closure
  • Fig. 8 is a schematic representation of a second embodiment of the medical
  • FIG. 9 shows a schematic representation of a third exemplary embodiment of the medical hollow body
  • FIG. 10 shows a schematic representation of a fourth exemplary embodiment of the medical hollow body
  • FIG. 11 shows a schematic sectional illustration of a seventh exemplary embodiment of the closure
  • Fig. 12 is a flow chart of a first embodiment of a method for
  • Fig. 13 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 which is designed in such a way that it engages at least in certain areas - in particular with an engagement projection 10 - in a distal opening 13 of a 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--in particular on the engagement projection 10--at least one first groove 15.1 with a groove direction 16 associated with 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.
  • Figure 2 shows a schematic representation of a second embodiment of the closure 1 with the engagement element 9.
  • the at least one first groove 15.1 is formed along a conical spiral, in particular the first groove 15.1 is formed as a conical spiral.
  • a winding axis 18 of the at least one first groove 15.1 and the axial direction 19 of the medical hollow body 3 are preferably parallel to one another when the closure 1 is arranged on the medical hollow body 3 in the closed position.
  • the groove direction 16 assigned to the at least one first groove 15.1 is a 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, with the starting point 20.1 and the end point 20.2 along the longest extent of the at least one first groove 15.1 are spaced apart.
  • the conical spiral particularly preferably has a pitch of 0.5 mm to 2 mm, preferably 1 mm.
  • the spiral-shaped first groove 15.1 has from 1 turn to 3 turns, preferably 1.75 turns.
  • the spiral-shaped first groove 15.1 tapers from 0° to 45°, preferably 20°.
  • Figure 3 shows a schematic representation of a third embodiment of the closure 1 with the engagement element 9.
  • the first groove 15.1 can be clearly seen.
  • 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 - in particular on the engagement projection 10 - at least one second groove 15.2, which extends in one plane, with a Is aligned normal direction of the plane along the groove longitudinal extension 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.
  • the closure 1--in particular the engagement element 9-- has 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 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.
  • Figure 4 shows a schematic representation of a fourth 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.
  • the normal direction of the plane in which the second groove 15.2 extends 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 enclose an angle of 0° to 18°.
  • FIG. 5 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.
  • the engagement element 9 is designed and arranged in such a way that it engages in the distal opening 13 of the medical hollow body 3 at least in certain areas - in particular with the in particular conically shaped engagement projection 10 - when the closure 1 is arranged on the medical hollow body 3 in the closed position.
  • the longitudinal extension 17 of the groove is aligned along the axial direction 19 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 two parts.
  • 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).
  • the engagement element 9 preferably has at least one elastomer, in particular at least one rubber.
  • 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. 6 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 rests sealingly at least on the distal area 11 of the medical hollow body 3 when the closure 1 is arranged on the medical hollow body 3 in a closed position.
  • the engagement element 9 is designed and arranged in the base body 5 in such a way that it engages in the distal opening 13 of the medical hollow body 3 at least in certain areas - in particular with the in particular conically shaped engagement projection 10 - when the closure 1 is arranged on the medical hollow body 3 is.
  • 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 extension 17 of the groove is in the closed position along the axial direction 19 of the medical Hollow body 3 aligned, in particular the longitudinal extension 17 of the groove 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 are aligned parallel to one another.
  • 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 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.
  • 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.
  • the internal thread 25, in particular the Luer thread, and the base body 5, in particular the lower part 21.2 are preferably formed 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 7 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 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.
  • FIG. 8 shows a schematic representation of a second exemplary embodiment of the medical hollow body 3 with the closure 1, which is arranged on the medical hollow body 3 in the closed position.
  • 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 that protrudes from the associated recess 27 in an axial direction.
  • the sealing element 7 has an axial anchoring element 29.2 that protrudes from the associated recess 27 in an axial direction.
  • a 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.
  • FIG. 9 shows a schematic representation of a third exemplary embodiment of the medical hollow body 3 with the closure 1, which is arranged on the medical hollow body 3 in the closed position.
  • FIG. 9 a) shows a first view and FIG 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. 9 b) due to the rotated view. Furthermore, the first recessed grip 37.1 and the second recessed grip 37.2 are not visible in FIG. 9b).
  • FIG. 9a A comparison of the two views from FIG. 9a) and FIG. 9b) 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 10 shows a schematic representation of a third embodiment of the medical hollow body 3 with the closure 1.
  • FIG. 10 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. 11 shows a schematic sectional illustration of a seventh 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 12 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 .
  • Figure 13 shows a flow chart of a second embodiment of a method for manufacturing 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 process or a multi-component injection molding process, with the sealing element 7 and the engagement element 9 being formed in one piece with one another.
  • the one-piece design of the sealing element 7 and the engagement element 9 is made of 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)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP22809003.1A 2021-10-21 2022-10-20 Verschluss für einen medizinischen hohlkörper, medizinischer hohlkörper mit einem solchen verschluss und verfahren zur herstellung eines solchen verschlusses Pending EP4419173A1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102021127435.4A DE102021127435A1 (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
PCT/EP2022/079241 WO2023067079A1 (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

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EP4419173A1 true EP4419173A1 (de) 2024-08-28

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US (1) US20250269115A1 (enExample)
EP (1) EP4419173A1 (enExample)
JP (1) JP2024539679A (enExample)
CA (1) CA3234796A1 (enExample)
DE (1) DE102021127435A1 (enExample)
MX (1) MX2024004783A (enExample)
WO (1) WO2023067079A1 (enExample)

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DE102021127437A1 (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

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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
ATE371470T1 (de) * 2004-05-29 2007-09-15 Gerresheimer Buende Gmbh Spritzenverschluss und verfahren zum herstellen eines spritzenverschlusses
JP5325549B2 (ja) * 2007-12-21 2013-10-23 三笠産業株式会社 合成樹脂製の栓
US9867975B2 (en) 2011-05-23 2018-01-16 Excelsior Medical Corporation Antiseptic line cap
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
DE102012022008A1 (de) * 2012-11-09 2014-05-15 Vetter Pharma-Fertigung GmbH & Co. KG Spritzenverschluss
US10376686B2 (en) 2014-04-23 2019-08-13 Becton, Dickinson And Company Antimicrobial caps for medical connectors
US10729616B2 (en) * 2014-08-04 2020-08-04 Genentech, Inc. Apparatus and methods for sealing a medicament within a medical delivery device
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
JP6558392B2 (ja) * 2017-04-04 2019-08-14 ニプロ株式会社 シリンジ型噴出装置
KR102083549B1 (ko) * 2019-03-19 2020-03-02 조아제약주식회사 약물을 수용하여 밀봉되는 용기
CN114206427B (zh) * 2019-07-24 2024-07-19 舒万诺知识产权公司 用于医疗工具的清洁盖
DE102021127437A1 (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

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CA3234796A1 (en) 2023-04-27
WO2023067079A1 (de) 2023-04-27
DE102021127435A1 (de) 2023-04-27
JP2024539679A (ja) 2024-10-29
US20250269115A1 (en) 2025-08-28
MX2024004783A (es) 2024-05-09

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