EP2788058A2

EP2788058A2 - Closure, particularly a syringe cap for closing a distal opening of a syringe body in a sealing manner

Info

Publication number: EP2788058A2
Application number: EP12824684.0A
Authority: EP
Inventors: Bastian Fischer; Christoph Huber; Edwin SCHELLENBERG; Heinz HÄBERLEIN; Mustafa Kücük; Thomas Fässler; Katharina JENÖFI; Levent Kusogullari
Original assignee: Schott Schweiz AG
Current assignee: Schott Pharma Schweiz AG
Priority date: 2011-12-09
Filing date: 2012-12-07
Publication date: 2014-10-15
Also published as: WO2013083279A3; US20140358078A1; WO2013083279A2; CN105188816A; DE102011120637A1

Abstract

The invention relates to a closure, particularly a syringe cap for closing in a sealing manner a distal opening, such as a syringe cone on a syringe body, wherein the closure, particularly the syringe cap, comprises a fastening element that is or can be arranged on the syringe body around the distal opening, particularly around the syringe cone, and a closure cap that can be loosely connected to the fastening element and closing in a sealing manner the distal opening, such as a syringe cone; the invention is characterised in that the fastening element comprises an inner thread that intermeshes with an outer thread on the closure cap, resulting in an initial state wherein the outer thread is formed on at least part of the closure cap, wherein said part is under tension in such a way that after the closure cap is unscrewed from the inner thread the part under tension is pressed out over the inner thread of the fastening element such that the closure cap cannot be returned to the initial state once the closure cap is unscrewed.

Description

Closure, in particular syringe closure for sealing

Closing a distal opening of a syringe body

The invention relates to a closure, in particular a syringe closure for the sealing closing of a distal opening or a syringe cone of a syringe body. In particular, the invention relates to a

Syringe closure with a syringe body about the distal opening, in particular the syringe cone arranged around or can be arranged

Fastener and a distal opening, in particular the

Syringe cone, sealingly closing and releasably connected to the fastener cap and the cap itself.

Such syringe seals have become known from a variety of patents. For example, US 6,190,364 shows a syringe closure for a syringe body. The syringe body itself has a distal tip and a distal opening extending therethrough, in particular in the form of a syringe cone, so that a liquid located in the syringe body can leave the syringe body through the distal opening or syringe cone. Furthermore, the syringe body comprises a fastener element which is arranged or can be arranged on the syringe body. This

Fastener may be integrally formed with the syringe or placed on the distal tip of the syringe body and firmly connected thereto. The fastener further comprises threaded elements or

Bayonet structures threaded with a two-piece

Collapse the cap to secure the cap to the cap

To hold fastener. The closure cap encloses the region of the distal tip or tip cone and seals and seals the distal opening of the syringe body. In order to be able to inject the syringe liquid, in US 6,190,364 the closure cap is screwed out of the attachment element and an injection cannula attached to the syringe body in such a way that a needle opening extending through the injection cannula is in a conductive connection with the distal opening of the syringe body.

CONFIRMATION COPY A problem with such syringe closures is that it should be ensured that they can not be used again in certain applications, for example with another drug or for others

Applications can be used again. Indeed, such a second use would involve a high risk of infection of the patient due to contamination, for example of foreign particles and germs. Another risk is that, for example, when reusing the

Syringe closure on a syringe body other than the original this problem is that contamination of the second drug takes place, since in the cap traces of the original drug may be present, which are registered in the second drug and can lead to a mistreatment in the patient.

To possible manipulations and a second use in the

To exclude syringe closure according to US 6,190,364, is the

Provide a syringe seal with a sealing strip which is releasably connected to both the fastener and with the cap, so that the seal strip breaks when the cap from

Fixing element is released. A disadvantage of a closure according to US Pat. No. 6,190,364 is that several separate parts have to be produced, which are subsequently connected to one another in a complicated manner.

From EP 1600190 A1, therefore, a syringe closure for sealing and closing has become known, in which, on the one hand, manipulations on the syringe opening are recognized, and on the other hand, production has been considerably simplified compared to US Pat. No. 6,190,364. For this purpose, EP 1 600 190 A1 has provided the fastening element with a latching means which is latched with a latching means of the closure cap. Furthermore, the locking means of both the fastener and the cap are designed such that they can not be unlocked without damage, that is, after unlocking no damage-free reclosing is possible. Although EP 1 600 190 A1 precludes damage-free re-latching, it is possible, at least at the cost of damage to lock the cap again with the fastener. Protection against repeated use in order to ensure a single use for a syringe is also not available from EP 1 600 190 A1.

From EP 1101505 a closure for a prefillable disposable plastic syringe with a syringe body and a directly connected in the exit end end of his injection needle, consisting of an outer rigid plastic needle cap made of hard elastic material, directly on the syringe body, the injection needle enveloping, placed is, and the inside, at least in the area of the needle tip, provided with a soft elastic material existing sealing lining has become known, wherein the plastic needle cap with the syringe body circumferentially welded directly or glued, to form a predetermined separation point in the welding or adhesive seam.

The object of the invention is thus to avoid the disadvantages of the prior art and a closure for sealing in particular one

Indicate syringe opening, which acts as a sterility barrier and as a protection against repeated use of the cap. Furthermore, these functions with as few components and thus a small

Production costs are made available.

The object is achieved according to a first aspect in that

According to the invention, a closure, in particular a syringe closure for the sealing closing of a distal opening, in particular one

Syringe cone of a syringe body is provided, wherein the syringe closure arranged on the syringe body around the distal opening, in particular the syringe cone around or arranged fastener and a distal opening, in particular the

Includes syringe cone sealingly closing and releasably connected to the fastener cap. According to the invention A syringe closure characterized in that the fastener comprises an internal thread which engages an external thread of the closure cap, resulting in an initial condition, the external thread being formed from at least a portion of the closure cap which is under tension, such that upon unscrewing the closure cap the

Fastening the live part is pushed beyond the internal thread, so that after unscrewing the cap, the cap can not be restored to the initial state. The bias is introduced by the assembly process. In this case, the hard component is already produced in the injection molding or manufacturing process in the spread state and biased by the merger with the internal thread of the fastener.

In the case of plastic syringes, the fastener or the

Attachment ring or the Luerkragen molded onto the syringe body, so that there is a one-piece component. In the case of glass syringes that is

Fastener or the mounting ring a separate component, the z. B. on a bead of the glass syringe in a predetermined, d. H. defined height locks. The tightness of the connection of the cap and distal opening or the cone of the glass syringe is also ensured the predetermined distance and the snap.

Due to the fact that the threaded parts of the closure cap that are under tension are pressed outward according to the invention after being unscrewed, reuse after disassembly of the closure cap is no longer possible.

The syringe closure according to the invention can be used both for a syringe body of a glass material, but also of a thermoplastic. As described above, the fastener in a syringe body of glass material is a separate component, preferably a fastening ring, which engages in a bead of the glass material at a predetermined height, whereas a syringe body made of a plastic, here a thermoplastic, the fastener is part of the syringe body.

In a particularly preferred embodiment, the closure cap comprises a base element made of an elastomer with which the distal opening,

For example, the syringe cone, is closed and a region which consists of a hard component, a so-called hard area. The

Pushing out the part of the closure cap beyond the internal thread preferably takes place in the region which consists of a hard component.

In this case, the tension can be introduced into the hard component itself. In an alternative embodiment, the function of pushing out the hard component when unscrewing is achieved by specially shaped elastomer components, in particular the base material or base element. It is particularly preferred if the hard component of the cap, which carries the external thread, with the base part, which preferably consists of a

Elastomer material consists, mechanically, especially in a distal

Opening, for example, the syringe cone sheathing area is connected. The mechanical connection of the threaded part or the hard part with the base part has the advantage that over-rotation of the base part is prevented. In order to make the cap sterilizable for all current sterilization methods, such as gamma radiation, ETO and steam at temperatures of 121 ° C. and more, as well as electron radiation, it is preferred that the elastomers of the base material be selected accordingly. This allows a wide application in addition to glass syringes also on syringes made of thermoplastics.

The grip region of the closure cap is preferably integrated into the base material or the base part of the closure cap. The hard area that the

Outer thread carries, is preferably designed as a spreading, which spreads after unscrewing the cap. The spread spreader then has a larger diameter than the inner diameter of the Internal thread on. This prevents the cap from being screwed back onto the syringe cone with a distal opening.

In order to guarantee protection against multiple use, it is provided in an improved embodiment that the base part only a small part of the

Syringe cone sheathed with the distal opening. This ensures that the base part alone without threaded part can not hold on the cone. Preferably, the threaded portion of the external thread comprises only a single cam, so that the cap is merely hooked into the internal thread of the syringe and can be turned off with only a quarter turn. To slipping or loosening of the internal thread, z. B. during storage or transport, it can be provided that the threaded portion in such an embodiment of the cap over

Forming method is connected to the internal thread.

All materials used for the closure cap, i. both the elastomer and the hard component are chosen so that they can be used for pharmaceutical use. Preferably, the materials have a USP Class VI classification. Furthermore, they are dyeable in a particular preferred embodiment.

As elastomers, as mentioned above, preferably for the pharmaceutical use approved elastomers and butyl rubber is used. As hard components, in particular for the hard component, among other things, all approved thermoplastics can be used, but particularly preferred are thermoplastics that survive as many types of sterilization without significant geometry or material changes. Exemplary thermoplastics are polycarbonate, polyether ether ketone, polyetherimide,

Polyether block amide, copolyester. In addition to the device, a method for producing the syringe closure is also specified.

Here, for the hard component is preferably a conventional

Injection molding applied, for the elastomer component can

Various methods are used, preferably the compression or vulcanization process. In addition, the elastomer component can also be produced by transfer injection or injection molding. The two components are brought together in a further process step by means of a mounting system and connected to each other.

The closure cap for closing, in particular the distal opening, in particular of the syringe closure consists according to a second aspect of the invention of a hard area and a hard area

Component comprising an elastomer, d. H. an elastomeric component, wherein the connection between the elastomeric component and the hard component is preferably positive fit and various types can be realized. The different possibilities of positive connection are shown in detail below.

In one embodiment of the closure cap includes the hard component, which is preferably designed in the form of a sleeve, in particular an outer cap, a through opening in the axial direction. The opening may be oval, circular or polygonal, in particular polygonal design.

The hard region or the hard component, in particular the sleeve, preferably the outer cap, in the first embodiment, comprises at least one axial section which, distributed over a circumference of the section, comprises at least one

Recess, in particular at least one breakthrough and / or grooves comprises. The distal portion of the outer geometry of the elastomeric component is designed to be congruent with the through-going opening of the hard component. In contrast to the hard component, the distal portion of the elastomeric component, also referred to as the base member, includes one or more radially projecting projections or elongated shaped ribs, which are in the design and number of elongate shaped recesses, particularly apertures within the hard components correspond. in the

assembled state, the projections or ribs of the elastomer component are then received by the punctures and / or the grooves of the hard component.

The outer diameter of the ribs or projections is advantageously so

dimensioned so that it is at least as large as the outer diameter of the hard component, preferably a little larger. By the protrusion of the ribs or projections on the hard component also gives an anti-slip pad, which greatly facilitates the gripping and rotating the cap. Furthermore, additional design elements for this purpose can be dispensed with.

By engaging the ribs or projections in the windows, both components are locked together axially and radially.

By unscrewing the cap from the fastener elastomer component is inevitably moved with the hard component in the axial and radial directions and thereby separated from the syringe cone.

In a further embodiment of a closure cap, the hard component includes an opening, in particular a continuously stepped opening in the axial direction, wherein the opening of the hard component on the distal side is smaller than the opening of the hard component on the proximal side.

According to the invention, the opening on the proximal side is annular and the opening in at least one axial section is not circular in cross section, especially designed oval or polygonal. In an embodiment with two axial sections of the opening, the opening in the distal section with a non-circular cross-section or a cross-sectional surface with non-circular inner contour includes ribs or projections which are directed inwards, ie radially from the inner contour into the axial opening of the hard Extend component. The number of ribs or projections preferably corresponds to the polygonal design of the opening. In such an embodiment, the distal region of the outer geometry of the elastomer component or the

Base part designed so that it is congruent with the continuous stepped opening of the hard component, d. H. a portion of the elastomeric component is not circular in cross section formed preferably polygonal. The non-circular outer contour portion, in one embodiment, includes grooves into which the hard portion ribs engage in the assembled state. By engaging the ribs in the grooves, both components are locked together axially and radially.

By unscrewing the cap from the fastener, the elastomer component is inevitably moved with the hard component in the axial and radial directions and thereby separated from the syringe cone.

In yet another embodiment of a compound of hard

Component and elastomer component, the hard component comprises an opening, in particular through-stepped opening in the axial direction, wherein the voltage applied to the ends of the hard component in the axial direction

Openings are made larger than an intermediate opening, ie, the cross section of the intermediate opening in the axial direction has a first cross section (Q ^, which is always less than the second cross section (Q ₂ ) and the third cross section (Q ₃ ) of the end portions The inner contour of the opening at the ends may be circular, oval or polygonal The inner contour of the opening in the first axial region is not circular or circular, in particular polygonal or polygonal or oval executed. The elastomer component or the base part is designed so that it is congruent with the continuously stepped opening of the hard component at least in the distal region. This type of design provides an axial locking of hard and elastomer component or base part.

When unscrewing the cap from the fastener, the elastomer component is inevitably moved with the hard component in the axial direction and thereby separated from the syringe cone. Due to the non-circular, in particular polygonal design of the two components, a rotation assurance is achieved according to the invention. That is, when the hard component is rotated to release, the elastomeric component or base rotates with it. Furthermore, the torque when unscrewing the cap is reduced by the polygonal configuration, as the

Elastomer component is taken. As a result, the effort can be significantly reduced.

The technical advantages of all three embodiments described above are in an efficient and robust design. The axial and radial connection of the two components can be realized in a simple manner. This in turn means that both components are produced inexpensively and the cost of production can be kept low.

According to a fourth aspect of the invention, a closure is to be specified in which a dropping of the closure cap is avoided by the syringe opening.

According to the invention, this fourth aspect of the invention is provided by a closure, in particular a syringe closure, for sealing a distal opening, for example a syringe cone of a syringe body, wherein the closure, in particular the syringe closure, at least one to the syringe body around the distal opening, in particular the Syringe cone arranged around or arrangeable fastener , in particular an expansion component with at least one expansion element and a distal opening, for example, the syringe cone sealingly closes and releasably connected to the fastener cap comprises, the closure cap in the region of the fastener material fit, preferably exclusively material fit with the fastener, in particular the expansion, preferably the Spreader connected, in particular welded. This prevents accidental dropping of the cap or jumping off.

The closure cap is preferred with the fastening element

laser welded and / or ultrasonically welded.

In particular, the closure cap in the region of the external thread or

Cam of the fastener with the

Fastener material materially connected.

The invention will be explained in more detail below, without being limited thereto, with reference to the figures.

Show it:

Fig. 1a-1b first embodiment of a syringe and an inventive

Closure in the initial state, i. sealed, this syringe being a plastic syringe;

2a-2b syringe closure according to the first embodiment in

unscrewed, opened state, wherein the syringe is a plastic syringe;

3a-3d base part of a syringe closure according to FIGS. 1a-2b;

Fig. 4a-4d threaded part of a syringe closure according to Fig. 1a-2b;

Fig. 5a-5d closure cap of Figure 1a-1b, consisting of base part and hard part with thread.

Fig. 6 individual components of the syringe closure according to the first

Embodiment, applied to a syringe, which is designed as a glass syringe;

7a-7d base part or base element of the closure cap of a second

Embodiment of a syringe closure according to the invention;

Fig. 8a-8d hard component with threaded portion of a second embodiment of a syringe closure according to the invention;

9a-9d closure cap with components according to FIGS. 7a-8d;

Fig. 10 syringe closure according to the second embodiment with

Components according to Figures 7a-9d, applied to a syringe, which is designed as a glass syringe. Fig. 11 a-11 b syringe and inventive closure according to the second embodiment of FIG. 7a-10 in the initial state, ie

sealed, the syringe being a plastic syringe;

12a-12b syringe closure according to the second embodiment in

unscrewed, opened state, the syringe is a plastic syringe.

Fig. 13a.1-

Fig. 13c.4 First embodiment of a closure cap, wherein the hard component or the hard component comprises at least one axial portion which comprises at least one opening and / or grooves distributed over a circumference and a thread.

Fig. 14a.1-

14c.4 embodiment as in Fig. 13.a.1 - 13c.4, wherein the hard component or

the hard component has cams

Fig. 15a.1-

Fig. 15c.4 Second embodiment of a closure cap, wherein the hard

Component or component has a thread and one in axial

Direction extending opening, in particular through opening, which has at least in one section an inner contour which is not circular and three axial sections.

Fig. 16a.1- Fig. 16c.4 embodiment as Fig. 15a.1 - 15c.4, wherein the hard component or

Component cam has

Fig. 17a.1-

Fig. 17c.4 Third embodiment of a closure cap, wherein the hard component or component has a thread and extending in the axial direction, in particular through opening, which has an inner contour in at least one section, not is circular, and an axial section with radial projections.

Fig. 18a.1-

Fig. 18c.4 embodiment as Fig. 17a.1-17c.4, wherein the hard component or

Component cam has

In Fig. 1a is a complete syringe closure 1 according to a first

Embodiment of the invention shown. The complete syringe closure 1 consists of a syringe body 3 with a distal opening 4. The distal opening 4 surrounds an elastomer, in particular an elastomer, suitable for

pharmaceutical use is authorized. As a result, the distal opening 4 of the syringe cone 5 is sealed in the closed state. Most preferably, the elastomer is also dyeable. Suitable elastomers are thermoplastic elastomers and butyl rubbers. The elastomers are selected so that the entire cap 7 with all common

Sterilization methods such as gamma sterilization, ETO or steam at 21 ° C and above or with electron beams can be sterilized. This allows a wide application of the caps, in addition to glass syringes on syringes of thermoplastics, as shown in FIGS. 1a-2b. In the case of plastic syringes, the fastening element 32 or the fastening ring and the plastic syringe or the syringe body 3, as shown, are a one-piece component.

In addition to the base element or the base part 10, the closure cap comprises at least one hard component or component 20 as the second component.

The hard component 20 contributes, as shown in detail in Figure 1b, a

External thread, with the internal thread 30 of the fastener 32 of the syringe body 3 in the initial state shown in Figure 1, i. in the

locked state engaged. The hard component 20 is mechanically connected to the base element or base part 10. For this purpose, the hard component 20 has a groove, which is in engagement with a bead 12 of the base part. The mechanical connection of the two components of the closure cap 7 ensures that spinning of the base part 10 is prevented.

The hard component or the hard area 20 of the closure cap 7 is, as shown in FIG. 1b, divided into a total of four expansion elements.

In the embodiment shown in FIGS. 1a to 2b, the hard component or the expansion element or the expansion elements themselves are under tension, specifically in the region of the notch 14. If the closure cap 10 is opened

turned out, so, as shown in Figures 2a to 2b, the hard component or the expansion elements beyond the internal thread pushed out.

In FIG. 1b, the same reference numerals as in FIG. 1a are used for the same components. In Figure 1b is merely shown, the cap 7, comprising the base part 10 and a total of four hard areas 20, which in the present case as

Spreading elements 24.1, 24.2, 24.3, 24.4 are formed and include an external thread 26, which in the screwed state, as shown in Figure 1b, with the

Internal thread (30) of the syringe body (3) is engaged.

In the figures 2a to 2b is shown how the syringe closure according to the first embodiment of a plastic syringe after opening the

Cap behaves.

Again, the same components with the same reference numerals as in Figures 1a and 1b are occupied. By unscrewing the cap 7 with base element 10 and hard element or area with external thread 22 from the internal thread 30 of the fastener 32 syringe body 3, the hard component or hard element, which is present in the area 14 under tension, above the Inner diameter of the fastener 32 of the syringe body. 3

pushed out. A screwing is then no longer possible. The distal opening 4 of the syringe cone 5 of the syringe body 3, the fastening element 32 of the syringe body, which carries the internal thread 30, and the region 8 of the base element 10, which abuts the distal opening as an elastomer, and these are tight in FIG closes.

FIG. 2b again shows the closure element or the closure cap 7, consisting of base element 10 and the four spreading elements 24.1, 24.2, 24.3, 24.4 with external thread 26. Due to the tension, the spreading elements are spread apart in the untwisted state and have a larger one

In the figures 3a to 6 are again sectional drawings of the individual components of the first embodiment of the closure cap with spreading, as shown in Figures 1a to 2b shown.

While the closure element or the closure cap (Figure 5a-d) consisting of base element 10 (Figures 3a-3d) and hard component (Figure 4a-4d) are identical to the embodiment in Figures 1a-2b, in Figure 6, the embodiment of the Fixing the cap on a glass syringe shown with a separate from the tip body mounting ring or

Fastener 332 of a bead of the glass syringe (not shown) engages.

FIGS. 3a to 3d show the base element 10 in a side view (FIG. 3a), in section (FIG. 3b) in a three-dimensional representation (FIG. 3c) and in a plan view (FIG. 3d).

Clearly visible is the area 18, which is the distal opening of the

Syringe cone of the syringe body (not shown) encloses. Furthermore, points the base element, as shown in Figures 3a and 3c, on his

Outside a handle portion 19.

With the base member 10 is shown in Figures 4a to 4d

Threaded ring, which is also referred to as a hard component, mechanically connected. Overall, as shown in FIGS. 1a to 2b, the threaded ring comprises a total of four hard areas, which are designed as spreading elements 24.1, 24.2, 24.3, 24.4, which are under tension in area 18, so that when the threaded ring and external thread 26 from the syringe body

is unfolded, spread. This can be clearly seen in FIGS. 4a to 4d.

FIGS. 5a to 5d show the mechanical assembly of the base part 10 according to FIGS. 3a to 3d with the threaded ring according to FIGS. 4a to 4d, resulting in the closure cap as shown in FIGS. 5a to 5d. The same components as in FIGS. 3a to 4d are used in FIGS. 5a to 5d.

In Figure 6 are again the items of the invention

Syringe closure shown, namely the base member 10, and the hard component 20 with the spreading elements 24.1, 24.2, 24.3, 24.4. The fastening element 332 with internal thread 30 is embodied here as a separate component to the syringe body. This embodiment is mainly used in glass syringes in which the fastening ring or the fastening component 332 is pushed over a bead of the glass syringe.

FIGS. 7a to 12b show a second embodiment of the invention. In contrast to the embodiment according to FIGS. 1 a to 6, with the configuration shown in FIGS. 7 a to 12 b, the hard component is made longer than the base part 110 itself, so that the base part 110 only a small part of the syringe cone or sheathed in the distal opening 105, so that the base part 110 according to FIGS. 7a to 7d does not work without the hard component which carries the thread and is shown in FIGS. 8a to 8d Syringe cone can be held with the distal opening. The area surrounding the syringe cone is shown in FIG. 7b and labeled 118. It is designed significantly shorter in length than the section 18 in Figures 1a to 2d of the first embodiment.

In general, for identical functional components in FIGS. 7a to 12

Reference numerals with 100 increased numbering referred to the reference numerals shown in Figures 1 to 6. Clearly visible in FIG. 7c are recesses 117.1, 117.2, 117.3, 117.4 introduced into the main body or the base element 110, which accommodates the spreading elements of the threaded element, as shown in FIGS. 8a to 8d. Furthermore, the base element 110 in the region of the external threads 117.1, 117.2, 117.3, 117.4 comprises a bead 119.1, which ensures that the spreading elements when unscrewing the closure cap from the distal opening or the

Be cone opening over the inner diameter of the syringe body pushed out. In the embodiment according to FIGS. 7a to 7d and 8a to 8d, therefore, the stress is not introduced into the hard element itself, but is made available by the elastomer of the base part. Various views of the hard area (s) are shown in FIGS. 8a to 8d. The hard element of the closure cap shown in FIGS. 8a to 8d comprises a total of four hard regions in the form of spreading elements 124.1, 124.2, 124.3, 124.4. The hard areas in turn have an external thread, but this is in this case a single cam 126 in contrast to the several

Threads of the external thread according to the figures 4a to 4d. The

Using only one cam for the external thread has the advantage that the closure cap with the help of the threaded part, consisting of only one cam in the internal thread 130 of the mounting ring 432 of the syringe 103 can only be hooked and can already be turned off with a quarter turn. This guarantees protection against multiple use, since the base part without the threaded part can not hold the syringe cone with the distal opening. In the embodiment according to FIGS. 7a-7c. 10 is again a Embodiment with separate fastener 432 z. B. for a

Glass syringe.

In order to prevent it from slipping off or being released into the initial state, i. in the closed state of the closure cap according to FIGS. 7a to 12 of the syringe body, it can be provided to connect the threaded part of the closure cap to the internal thread of the syringe cone via shaping processes. FIGS. 9a to 9d show the closure element or the closure cap composed of the components 7a to 8d. Again, the same components with the same reference numerals, as in Figures 7a to 8d, occupied.

FIG. 0 then shows the assembly to the invention

Syringe closure, consisting of base member 110, hard element 120 and fastener 432 as a separate component for a glass syringe.

In FIGS. 11a to 12b, analogous to FIGS. 1a to 2b, in a three-dimensional representation for the second embodiment, the closure is in the initial state, as shown in FIGS. 1a and 1b, and after unscrewing by a quarter turn of only one thread of the closure cap according to the invention according to Figures 2a and 2b of

Syringe closure in open position. Again it is one

Plastic syringe in which the fastener 132 is part of the syringe body 103.

The same components as in FIGS. 7a to 10 are designated by the same reference numerals in FIGS. 11a-11b. Analog components as in Figures 1 to 6 are occupied by 100 higher reference numerals. In particular, the syringe body 103 is shown in FIG. 11a, which is connected to the closure cap 107 in the region of the spreading elements 124.1, 124.2, 124.3, 124.4. In order to prevent the cap 107 from jumping off, the closure cap 107 is in the area of the cap External thread 122 of the Spreizelementel 24.1, 124.2 welded to the internal thread 130 in the region of the fastener 132 of the syringe body, for example, laser welded. Two, 124.1, 124.2 out of the four

Spreading 124.1, 124.2, 124.3, 124.4 have cams 150, which are shown in Figure 12 b and 11 b, which can be very little screwed into the internal thread 130 of the syringe body. After a small one

Rotational movement about, for example, a quarter turn breaks when unscrewing according to Figure 12a, the laser welding between cap, the external thread or the cam 150 and the internal thread 130 of

Fastener 132, and the cap 107 drops from the syringe with a distal opening 05 and a syringe opening.

The closure caps 7, 107 shown above are

Closure caps, in which according to the figures 3a to 6, the elastic element is anchored within a groove in the hard component against axial displacement. Furthermore, the embodiment has a projection of the elastic element, which allows a very good grip and unscrewing the

Cap supported. In Figures 13a.1 to 14c.4 a first embodiment of an alternative cap is shown, which is characterized in that the hard

Component or the hard area breakthroughs or grooves, in the at least one rib or projection (400) of the base element (10)

Engage elastomer or the elastomer component. In this case, the two configurations according to FIGS. 13a.1 to 13c.4 differ from FIG

14a.1 to 14c.4 characterized in that in one case in the embodiment according to FIG. 13a.1 to 13c.4, the hard component has a Spreizbauteil with a thread, whereas in the embodiment of FIG. 14a.1 to 14c.4 has the hard component spreading with cams.

In Fig. 13a.1 - 13c.4 the entire cap is again with the

Reference numeral 7 denotes. Fig. 13a.1 shows the cap with the base part or the elastic component 10 and the hard component or component 20 in an assembled version. In Fig. 13a.2 the cap 7 is divided into the two components, namely the hard component 20 and the elastic component 10th

13a.3 shows the hard component 20 with the elastic component or

Elastomer component 10 in side view. Clearly visible are the spreading elements 24.1, 24.2, 24.3 and the openings 402 in the axial section

401, which are distributed over the circumference.

The section B-B through the component 20 with the elastic component 10 according to FIG. 13a.3 is shown in FIG. 13a.4. Clearly visible on average the breakthroughs

402, which are distributed over the circumference and engage in the assembled state, as shown in Fig. 3a.1, in the projections 400 of the elastic component 10.

Fig. 13a.5 shows a top view of the hard component 20 with the built-in elastic component. Clearly visible are the spreading elements 24.1,

24.2, 24.3, 24.4. Sections A-A and E-E of Fig. 13a.5 are shown in Figs. 13a.6 and 13a.7. The installation of the elastic component 10 is clearly recognizable. As section E-E clearly shows in FIG. 13 a, the ribs or projections 400 of the elastic component 10 engage in the openings 402 of the hard component 20. The protrusions 400 can be clearly seen in FIGS. 13b.1 to 13b.4, which illustrate the elastic component 10 in detail.

In addition to the ribs or projections 400, which engage as described in recesses 402 of the hard component 20 and thus an axial and radial

Moving the Elastomerbauteiles or the elastic component 10 within the hard component 20 prevent the elastic component 10 comprises further ribs 406 which in the interstices of the spreading elements 24.1, 24.2,

24.3, 24.4 of the hard component intervene. The section in Fig. 13b.3 and the side view according to 13b.4 of the elastic member 10 are with the same Reference numerals as previously awarded. 13c.1 to 13c.4 are views of the hard component 20, wherein FIG. 14c.1 is a three-dimensional view of the hard component 20 with window cutouts 402. The opening 405 of circular cross-section 407 passing through the hard component in the axial direction can clearly be seen. Although the cross-section of the opening 405 is circular, this is not mandatory. The opening could also be oval or polygonal. Fig. 14c.2 is a plan view, Fig. 14c.3 is a sectional view CC and Fig. 14c.4 is a side view of the hard component 20. Instead of a thread in the hard component 20, a

Embodiment be provided, in which the expansion component hard component comprises no thread, but only cam 150, as in the embodiment according to FIGS. 7a to 12b. The same components as in FIGS. 7a to 12b are designated by the same reference numerals, in particular the spreading elements with cams 150 with the reference numerals 124.1, 124.2, 124.3 and 24.4 as well as the closure cap with reference number 107.

Fig. 14a.1 again shows the component consisting of hard component 120 and elastic component 110 in the assembled, d. H. assembled state, Fig. 14a.2 in the disassembled state. The hard component is designated 120, the soft component or the component 110.

The same components as in FIGS. 13a.1 to 13c.4 are increased by 100

Reference numerals marked. Fig. 14a.3 denotes a side view of the assembled component, Fig. 14a.4 is a sectional view BB. In Fig. 14a.5 a plan view of the assembled component is shown in Fig. 14a.6 the section AA and in Fig. 14a.7 the section EE. As is apparent from Fig. 14a.1, engage the projections 500 of the elastic component 120, the recesses 502 of the hard component 110 in the assembled state and prevent radial and axial displacement of the elastic component 110 in the hard component 120. The openings 502 of the hard Component 120 is distributed circumferentially in section 501 arranged. Figures 14b.1 to 14b.4 again show the elastic

Component, d. H. the component of elastomer 110 in different

Views. As can be seen on the three-dimensional view according to FIG. 14b.1, the component 110 adjacent to the projections 500 is characterized by grooves 510 in which the spreading elements 124.1, 124.2, 124.3, 124.4 of the hard component 20, as in FIGS. 14c.1 to 14c.4 shown, intervene. Fig. 14c.1 shows the hard component in a three-dimensional view. Clearly visible is the through opening 505 which, in the present case, without restriction, shows a circular cross section 507.

FIGS. 15 a 1 to 18 c show two embodiments of a closure cap in which the hard component or the hard area or the hard component 20 has a through opening 705, wherein the

Through opening 705 includes at least a portion 7 3, which has a cross-sectional area with an inner contour 715, which is not circular.

15a.1 to 15c.4 shows a first embodiment of such a component, in which the hard component comprises a spreading member with a thread according to FIGS. 1a to 6, which is inserted in the spreading feet 24.1, 24.1, 24.3, 24.4 of the hard component is. The hard component is again denoted by 20, the soft component by 10.

Fig. 15a.1 shows the cap 7 in assembled, d. H. mounted form, wherein the elastic member is largely completely absorbed by the hard component or the hard component in the through hole 705 and at least partially enclosed. FIG. 15 a shows the individual components or components, namely the hard component 20 and the elastic component 10.

In Fig. 15a.3, the hard component or the hard component 20 is shown with inserted in the side view. Fig. 15a.4 shows section BB elastic component 10. It can be clearly seen in section BB, the cross-sectional area of the through hole 705 with an inner contour 713 of the hard component, which is not circular is. Clearly visible, the soft component 0, which is embedded in the through hole 705 of the hard component 20 and a first

Cross-sectional area Qi includes with non-round outer contour. As is apparent from Fig. 15a.4, the elastic member 20 is completely received in the opening 705 of the hard component 20. In addition, the elastic member 10, as the section A-A shown in FIG. 15a.5 and 15a.6 shows three sections in the axial direction. A first section 700.1, a second section 700.2 and a third section 700.3, the second and third sections being made wider than the first section 700.1. This can also be seen in detail in FIGS. 15b.1 to 15b.4, which show in detail the elastic component 10, preferably the elastomer component. By forming the first section 700.1 of the soft component 10 with a smaller width than the sections 700.2 and 700.3 in the radial direction, an axial displacement of the elastic member 10 within the hard component 20 is prevented. Furthermore, twisting of the component 10 in the hard region 20 of the closure cap 7 during unscrewing is prevented by the non-circular, in particular polygonal, preferably quadrangular cross section Qi in the first section 700.1 of the component 10. This can be seen particularly well in the three-dimensional view in FIG. 15b.1. Fig. 15b.2 shows a plan view of the soft component, Fig. 15b.3 is a side view and Fig. 15b.4 a section. Clearly visible in the three-dimensional view in Fig. 15b.1, the ribs 706, between the individual

Spreading elements 24.1, 24.2, 24.3, 24.4 engage the hard component. The hard component is shown in Figs. 15c.1 to 15c.4, with particular reference to Fig. 15c.1 showing the hard component in a three-dimensional view and the shape of the hard component corresponding to the soft component is and is characterized by a polygonal cross section 713 in the

characterized by continuous opening 705.

FIGS. 16a.1 to 16c.4 show an embodiment of a closure cap 107 as described in FIGS. 15a.1 - 15c.4, in which the expansion elements 124.1, 124.2, 124.3, 124.4 of the hard component 120 do not comprise a thread, but instead only cams 150, as shown in Figs. 7a to 12b. Same components are again assigned the same reference numerals. In the embodiment of the hard component with cams 150 in the region of the spreading elements, in turn, an elastic element 110 is introduced, which is essentially the same as the elastic element 110 in FIGS. 15a.1 to 15c.4 at least in the area of the through opening 805, Therefore, the same components are referred to by 100 increased reference numerals. As in FIGS. 14a.1 to 14c.4, the elastic component comprises grooves 510 for receiving the spreading elements.

FIGS. 17a.1 to 18c.4 show a further variant of an embodiment, as described in FIGS. 15a.1 to 16c.4, in which again the hard component 20 has a through opening 905 with at least one axial one

Section 915, which has a cross-sectional area with an inner contour 913, which is not circular, but preferably oval or polygonal. Again, the same components as in the previous figures are occupied by reference numbers increased by 100. Figure 7a.1 shows the component in assembled version, Fig. 17a.2 the hard component 20 and the elastic member 10 before the

Assembly. The elastic member 10 has as shown in Fig. 17a.2 shows two sections. A section 900.1 and a section 900.2. The first section 900.1 further comprises indentations 910, which are embedded in the substantially polygonal section 800.1. In the

Recesses 910 in the area 900.1 engage in the mounted or

Assembled state projections 920 of the hard component 20 as shown in Fig. 17a.6 a. In the sectional view Fig. 17a.6 is in addition to the engagement of the projections 920 in the recesses 910 of the elastic component 10 also clearly visible, the individual spreading elements 24.1, 24.2 threaded.

FIGS. 17b.1 to 17b.3 once again show the elastic component 10 and in particular the indentations 910 in the region of the first section 900.1 in which the elastic component 10 has a non-circular cross-section Qi of polygonal cross-section. The cross section Q _{2 of} the second section 900.2 is in this case again circular. Also visible are the ribs 406 in Area of the spreading mounted in the state of the cap 7

Condition of the cap 7.

The hard component according to FIGS. 17c.1 to 17c.4 in a perspective view, a plan view, as well as a sectional view and a side view clearly show the

Projections 920 which engage in the recesses of the elastic member 10 and thus prevent axial displacement of the elastic member when unscrewing the cap 7. It is not clear either

circular here polygonal cross-section of the through opening 905. Although previously always the opening as through the hard component was described throughout this is not mandatory. The invention can also be practiced when the hard component is an opening which is not continuous, but for example in the form of a bore is formed. This is not shown in figures here, but obvious to those skilled in the art.

FIGS. 18a.1 to 18c.4 relate essentially to components in which the expansion elements of the hard component have cams 150 in the expansion elements instead of the thread. Identical components are designated as in FIGS. 7a to 12b. Furthermore, the embodiment according to FIGS. 18a.1 to 18c.4 comprises an elastic component 110, which essentially has the same structure as the elastomer or elastic component 10 in FIGS. 17a.1 to 17c.4 with all those mentioned therein Has advantages. Same components as in FIG.

17a.1 to 17c.4 are designated by reference numerals increased by 100. Again to recognize the grooves 1100 in the elastic member 10 in which the Spreizfüße 124.1, 124.2, 124.3, 124.4 engage.

The invention for the first time specifies a very simple syringe sealing system for the sealing closure of a distal opening of a syringe body, which guarantees a multiple use, in particular a screwing back of the closure cap. Furthermore, the invention comes with very few items, which ensures easy manufacturability. By choosing the elastomers for the base element or base part and hard Components for the hard areas that carry the external thread, it is possible to present a cap that fits with all common

Sterilization methods is feasible and allows a wide application, in addition to glass syringes on syringes made of thermoplastics.

Claims

claims

1. closure, in particular syringe closure (1) for sealing

Closing a distal opening (4), for example one

Injection cone (5) of a syringe body (3), wherein the closure, in particular the syringe closure on the syringe body (3) around the distal opening (5), in particular the syringe cone around

arranged or disposable fastener (32) and the distal opening (4), for example, the syringe cone (5) sealingly closing and releasably connected to the fastening element (32)

Includes closure cap (7),

characterized in that

the fastening element (32) comprises an internal thread (30) which engages with an external thread (22) of the closure cap (7), resulting in an initial state, wherein the external thread (22) is formed on at least part of the closure cap (7), wherein the part is under tension, such that after unscrewing the

Closing cap (7) from the internal thread (30), the part under tension over the internal thread (30) of the fastener (32) is pushed out, so that after unscrewing the

Lock cap (7), the cap (7) not in the

Initial state can be spent.

2. closure, in particular syringe closure according to claim 1,

characterized in that the syringe body (3) consists of a

Glass material and / or a thermoplastic material.

3. closure, in particular syringe closure according to one of claims 1 to 2,

characterized in that

the closure cap (7) comprises an elastomeric base element (0) and at least one hard region (20).

4. closure, in particular syringe closure according to claim 3,

characterized in that

the tension is introduced into the hard area (20) of the closure cap (7).

5. closure, in particular syringe closure according to any one of claims 1 to 5,

characterized in that

the hard area (20) with external thread (22) with the base part (10) mechanically, in particular in a distal opening 4, the

Syringe cone (5) sheathing area, connected.

6. closure, in particular syringe closure according to one of claims 1 to 5,

characterized in that

the base part (10) is designed such that it encloses only a short section of the distal opening (4), the syringe cone (5), such that the base part (10) only cooperates with the hard area (20)

External thread (22) on the distal opening (4), the syringe cone (4) is held.

7. closure, in particular syringe closure according to one of claims 1 to 6,

characterized in that

the hard area (20) as an expansion component with at least one

Spreading element (24.1, 24.2, 24.3, 24.4, 124.1, 124.2, 124.3, 124.4) is formed, wherein the expansion component after unscrewing the

Cap (7) spreads and has a larger diameter than the diameter of the fastener (32) with internal thread (30).

8. closure, in particular syringe closure according to one of claims 1 to 9,

characterized in that

the base part (10) made of marine myplas, in particular elastomer

thermoplastic elastomer, butyl, chlorobutyl, bromobutyl or

Polyisoprene rubber which is approved for pharmaceutical use.

9. closure, in particular a spray closure according to one of claims 3 to 8,

characterized in that the hard area (20) of the closure cap (7) comprises at least one axial portion which distributed over a circumference (401) of the portion at least one recess (402), in particular at least one aperture and / or grooves, and Elastomeric base element (10) or the elastic component (10) comprises a further axial section which, distributed over the circumference of the further axial section, comprises at least one raidally protruding projection or rib (400) arranged in such a way in that the projection (s) and / or rib (s) (400) of the base part (10) in an assembled state of the closure cap (7) of the recesses (402), in particular the or

Breakthrough (break) and / or the (groove) are recorded.

10. A closure cap according to claim 9,

characterized in that the hard area (20) in the form of a sleeve, in particular an outer cap is formed, wherein the sleeve, in particular the outer cap has an opening preferably through opening (405) in the axial direction for receiving the base part (10) in the mounted state the cap.

11. A closure according to any one of claims 9 to 0,

characterized in that

the hard area (20) in the form of a sleeve, in particular a

Outer cap is formed, wherein the at least one recess (402) in particular the opening is a substantially elongated opening in the sleeve, in particular the outer cap.

12. A closure according to claim 11,

characterized in that

the projection (s) (400) of the base part (10) pass through the recess (s) (402), in particular breakthrough (breaks) of the hard area (10) in the form of one of the sleeve and outer cap and over the circumference the sleeve or outer cap survive.

13. Closure according to one of claims 10 to 12,

characterized in that

the opening, in particular the continuous opening in the axial direction of the hard component in the form of a sleeve, in particular the outer cap has a cross-section which is circular, oval or polygonal ..

14. closure, in particular syringe closure according to one of claims 3 to 8,

characterized in that

the hard area (20) of the closure cap (7) is in the form of a sleeve, in particular an outer cap, wherein the sleeve, in particular the outer cap preferably has a through opening (805, 905, 1005) in the axial direction for receiving the Base part (10) in an assembled state of the closure cap (7), wherein the opening, preferably the through opening at least in an axial portion having a cross-sectional area with a

Inner contour, which is not circular, in particular oval or polygonal.

15. A closure according to claim 14,

characterized in that

the base element or the elastic component (10) has at least two axial sections (700.1, 700.2, 800.1, 800.2, 900.1, 900.2, 1000.1, 1000.2) in the axial direction, a first axial section (700.1, 800.1, 900.1, 1000.1), which comprises a first cross-sectional area (Qi) and a second axial portion (700.2, 800.2) comprising a further second cross-sectional area (Q ₂ ), at least the first one

Cross-sectional area (Q ₁ ) has an outer contour which is the inner contour (715) of the opening (705) of the hard component, in particular the sleeve, in particular the outer cap in the axial portion (700.1, 800.1), in which the cross-section of the opening non-circular, in particular oval or polygonal, corresponds.

16. A closure according to claim 15,

characterized in that

the first axial portion (900.1) of the base member (s) (10) has one or more recesses (910) in at least one or more projections (920) of the hard member (20) beyond the inner contour of the opening (905) of the hard component (20) protrude, engage.

17. A closure according to any one of claims 14 to 16,

characterized in that

the elastic element or base part (10) has a third axial section (700.3) which comprises a third cross-sectional area (Q ₃ ).

18. A closure according to any one of claims 15 to 17,

characterized in that

the second (Q ₂ ) and / or third cross-sectional area (Q ₃ ) is greater than the first cross-sectional area (Q ₁ ).

19. A closure according to any one of claims 9 to 18,

characterized in that

the elastomeric base element (10) or the elastic element or elastic component comprises a thermoplastic elastomer, butyl, chlorobutyl, bromobutyl or polyisoprene rubber, which is approved for pharmaceutical use.

20 closure cap (7) for closing an opening, in particular a distal opening (4), for example, a syringe cone of a

Syringe body (3) with at least one base element (10) made of an elastomer or elastic component and at least one hard area (20)

characterized in that

the hard region (20) of the closure cap (7) comprises at least one axial section which, distributed over a circumference (401) of the section, comprises at least one recess (402), in particular at least one aperture and / or grooves, and the base element (10) elastomeric or elastic component comprises a further axial portion which distributed over the circumference of the further axial portion at least one raidal protruding projection or a rib (400) is arranged such that the or the

Projection (jumps) and / or rib (s) (400) of the base part (10) a mounted state of the closure cap (7) of the or

Recesses (402), in particular breakthrough (breaks) and / or the or (groove) are recorded.

21. A closure cap according to claim 20,

characterized in that the hard area (20) in the form of a sleeve, in particular an outer cap is formed, wherein the sleeve, in particular the outer cap has an opening preferably through opening (405) in the axial direction for receiving the base part (10) in the assembled state of the cap.

22. cap (7) according to any one of claims 20 to 21,

characterized in that

the hard area (20) in the form of a sleeve, in particular a

Outer cap is formed, wherein at least the recess (402), in particular the one opening is a substantially elongated opening in the sleeve, in particular the outer cap.

23 closure cap (7) according to claim 22,

characterized in that

or the projection (jumps) (400) of the base part (10) through the recess or recess (402), in particular breakthrough (breaks) of the sleeve or outer cap and extend over the circumference of the sleeve or

Survive outer cap.

24. cap (7) according to any one of claims 21 to 23,

characterized in that

the opening, in particular continuous opening in the axial direction of the hard area in the form of a sleeve, in particular the outer cap has a cross-section which is circular, oval or polygonal.

25 cap (7) for closing an opening, in particular a distal opening (4), for example, a syringe cone, a

Syringe body with at least one base element made of an elastomer

(10) and at least one hard area (20)

the hard area (20) of the closure cap (7), wherein the hard area (20) of the closure cap (7) is in the form of a sleeve, in particular an outer cap, wherein the sleeve, in particular the

Outer cap one opening preferably has a through opening (705,

905, 1005) in the axial direction for receiving the base part (10) in an assembled state of the closure cap (7), characterized in that

the opening, preferably the through opening, at least in an axial section has a cross-sectional area with an inner contour which is not circular, in particular oval or polygonal.

26. Cap (7) according to claim 25,

characterized in that

the base element or the elastic component (10) has at least two axial sections (700.1, 700.2, 800.1, 800.2, 900.1, 900.2, 1000.1, 1000.2) in the axial direction, a first axial section (700.1, 800.1) having a first cross-sectional area (Qi) and a second axial section which comprises a further second cross-sectional area (Q ₂ ), wherein at least the first cross-sectional area (Qi) has an outer contour which corresponds to the inner contour (715) of the opening (705) of the hard area (20). , in particular the sleeve, in particular the outer cap in the axial section (700.1, 800.1), in which the cross section of the opening is not circular, in particular oval or polygonal, corresponds.

27. Cap (7) according to claim 26,

characterized in that

the first axial portion (900.1) of the base member (s) (10) has one or more recesses (910) in at least one or more projections (920) of the hard member (20) beyond the inner contour of the opening (905) of the hard area or the sleeve protrude, engage.

28. Cap (7) according to one of claims 25 to 27,

characterized in that

the elastic element or base element (10) has a third axial section (700.3) which comprises a third cross-sectional area (Q ₂ ).

29. A closure cap according to any one of claims 26 to 29, characterized

in that the second (Q ₂ ) and / or third cross-sectional area (Q ₃ ) is greater than the first cross-sectional area (Q-1).

30. cap (7) according to any one of claims 20 to 29,

characterized in that

the base element (10) made of elastomer or the elastic element is a thermoplastic elastomer, butyl-.Chlorbutyl-, Bromobutyl- or

Polyisoprene rubber which is approved for pharmaceutical use.

31. closure, in particular syringe closure for sealing

Closing a distal opening, for example, a syringe cone of a syringe body, wherein the closure, in particular the

Syringe closure a to the syringe body around the distal opening, in particular the syringe cone around arranged or arranged fastener (132), in particular a Spreizbauteil with at least one spreading element (124.1, 124.2, 124.3, 124.4) and the distal opening, for example, the syringe cone (105 ) sealing

comprising closing cap (107) releasably connected to the fastening element (132),

characterized in that

the closure cap (107) in the region of the fastening element (132) materially, preferably exclusively materially connected to the fastening element, in particular the expansion member, preferably the spreader (124.1, 124.2, 124.3, 124.4) connected, in particular welded.

32. A closure according to claim 31,

characterized in that

the closure cap (07) with the fastening element (32) laser welded and / or ultrasonically welded.

33. A closure according to any one of claims 31 to 32,

characterized in that

the cap (107) in the region of the external thread with the

Cap is materially connected.