CA2717195A1 - Tamperproof seal with a retaining pin - Google Patents

Tamperproof seal with a retaining pin Download PDF

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Publication number
CA2717195A1
CA2717195A1 CA2717195A CA2717195A CA2717195A1 CA 2717195 A1 CA2717195 A1 CA 2717195A1 CA 2717195 A CA2717195 A CA 2717195A CA 2717195 A CA2717195 A CA 2717195A CA 2717195 A1 CA2717195 A1 CA 2717195A1
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CA
Canada
Prior art keywords
break
tamperproof seal
seal according
retaining
length
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.)
Abandoned
Application number
CA2717195A
Other languages
French (fr)
Inventor
Christiane Lowke
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.)
Bayer Pharma AG
Original Assignee
Bayer Schering Pharma AG
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 Bayer Schering Pharma AG filed Critical Bayer Schering Pharma AG
Publication of CA2717195A1 publication Critical patent/CA2717195A1/en
Abandoned legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3103Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104Caps for syringes without needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3103Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3106Plugs for syringes without needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3117Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • A61M2005/312Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/344Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/347Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Closures For Containers (AREA)

Abstract

The invention relates to a tamperproof seal for a container or a syringe, with a lockable conical adapter which is sealed in a sterile manner by means of a rubber stopper and is protected by a safety sleeve, wherein the safety sleeve, which is pushed non-releasably onto the conical adapter lock, comprises a retaining part, a break-off part and a break-off zone located between said parts. The break-off part encloses the rubber stopper without radical contact. It has a retaining pin, the free end of which rests axially on the rubber stopper - when the tamperproof seal is fitted, and it has at least two open apertures. The length of the break-off part corresponds to at least twice the length of the internal thread of the conical adapter lock.

The present invention produces a tamperproof seal which ensures safe handling of the combination comprising the container or syringe and tamperproof seal.

Description

Tamperproof seal with a retaining pin l Description:
The invention relates to a tamperproof seal fox a container or a syringe, with a lockable conical adapter which is sealed in a sterile manner by means of a rubber stopper and is protected by a safety sleeve, wherein the safety sleeve, which is pushed non-releasably onto the conical adapter lock, comFrises a retaining part, a break-off part and a break-off zone located between said parts.
US 6,520,935 B1 discloses a tamperproof seal of this type. In the subject matter therein, the rubber stopper sits in the break-off part in a form-fitting manner. As a restlt, the filled container bearing the tamperproof seal is completely opened upon the break-off part being broken off ox torn off.
EP 1 034 810 B1 likewise discloses a tamperproof seal with a safety sleeve which can be partially removed by being broken off. In this case too, the rubber stopper is pulled from the conical adapter when the break-off part is broken off.

The present invention is based on the problem of producing a tamperproof seal for a container or a syringe, which tamper-proof seal ensures safe handling of the combinaticn comprising the container or syringe and tamperproof seal and crhich can, be partially removed in a simple manner such that the container or the syringe is still sealed in a sterile manner thereafter.

The problem is solved by the features of Claim 1. "o this end, the break-off part of the safety cap surrounds the rubber stopper without radial contact. The break-off part has a retaining pin, the free end of which tests axially on the rubber stopper - when the tamperproof seal is fitt?d. The break-off part has at least two open apertures. Tha length of the break-off part corresponds to at least twice tie length of the internal thread of the conical adapter lock.

The present tamperproof seal is used for filled containers or syringes. In the present case, it guarantees, for example, safe and sterile sealing of a cartridge filled with a diagnostic means for magnetic resonance tomography. like many other prefilled containers, this cartridge, including its tamperproof seal, also has to be brought into a sterile condition by autoclave treatment. In order to ensure the sterility of the assembly comprising the container and tamperproof seal, liquid residues must not remain behind in the region of the tamperproof seal during the drying operation. In order to prevent this, the parts involved: the internal thread adapter, the rubber stopper and safety cap are in contact predominantly via linear and/or spot-type contact.
Large capillary gaps in which residual moisture from the autoclave treatment could be troublesomely retained are prevented.
The safety cap of the tamperproof seal has a break-off part which surrounds the rear part of the rubber stopper without coming into contact therewith in the radial direction, with respect to the centre line of the tamperproof seal. However, said safety cap presses the rubber stopper in a retaining manner against the outer cone of the lockable conical adapter.
By means of this configuration, it is possible to separate or start to tear off the break-off part of the safety cap from the retaining part thereof without the rubber stopper being pulled off the outer cone.

Further details of the invention emerge from the dependent claims and the description below of a schematically to illustrated embodiment.

Figure 1: a syringe with an internal thread adapter and rubber stopper placed thereon;
Figure 2: a safety cap, placed over the parts frcm Figure 1;
Figure 3: the upper part is broken off from the Safety cap to release it;
Figure 4: open syringe, the rubber stopper has been removed;
Figure 5: longitudinal section A-A, transversely to the illustration according to Figure 2;
Figure 6: longitudinal section B-B, cf. the sectional profile according to Figure 7;
Figure 7: cross section through the safety cap, cf. the sectional profile according to Figure Figure 8: cross section through the safety cap, the lockable conical adapter and the rubber stopper, cf. the sectional profile according to Figure (;
Figure 9: perspective illustration of the safety cap obliquely from above;
Figure 10: interior view of the safety cap;
Figure 11: as Figure 9, but pivoted through an an(-le of approx. 170 degrees.

In the exemplary embodiment, the present tamperprcof seal serves to seal a syringe barrel (10) in a sterile manner. To this end, the syringe barrel (10) has a lockable conical connection in the form of an outer cone (12) with n internal thread adapter (20) which can be latched into position. The outer cone (12) is sealed by a rubber stopper (40), cf.
Figure 1. A safety cap (60) is pulled over the internal thread adapter (20) and the rubber stopper (40), cf, Figu:-e 2.
According to Figure 5, the syringe barrel (10) has a barrel base (11) which merges in the form of a funnel int) an outer cone (12). The outer cone (12), for example a Luer outer cone according to DIN 13090, Part 1, has a central disciarge bore (13). The discharge bore (13) has a cross section )f, for example, 5.6 mm2.

A truncated cone section (14) which has a cone angle of approx. 14 degrees and tapers in the direction of the outer cone (12) is located below the outer cone (12). Tha length of the truncated cone section (14) is approx. 1/3 of the length of the Luer outer cone.
An encircling annular channel (17), the channel base of which is in the shape of a barrel casing, is located between the barrel base (11) and the truncated cone section (14). The annular channel (17) is approx. 2 mm wide. It serves to receive the internal thread adapter (20).

According to Figures 5 and 6, the internal thread adapter (20) is a tubular body with a central stepped bore (22). The latter comprises a threaded zone (23) and a plurality of bore sections (26, 28, 29). The threaded zone (23) has an internal thread (24), for example a double-threaded right-Land thread with a pitch of 5 mm, cf. DIN 13090, Part 2. The threaded zone (23) is adjoined by a front bore section (26) which has a diameter which is slightly smaller than the core dameter of the internal thread (24).

The bore section (26) is followed by an adapter base (27) with 5 a central bore (28). The adapter base (27) is an inner flange which sits with play in the annular channel (17) o_ the syringe barrel (10). Below the adapter base (27) t'iere is a rear bore section (29) which ends towards the cyl,ider base (11), for example in a planar end surface (38) The internal thread adapter (20) essentially has a cylindrical outer wall (31) on which a plurality of longitudinal webs (32), for example 12 of the same, are arranged, cf. Figures 1 and 6. The rectilinear longitudinal webs (32) are distributed is equidistantly over the circumference of the outer Ball (31).
They begin approx. 0.8 mm below the upper end surface (21) with a 45 bevel and reach as far as the lower endsurface (38). The upper end surface (21) is rounded at its outer edge, for example with a radius of 0.5 mm.
The individual longitudinal webs (32) have a semicircular cross section, wherein the chord length thereof, positioned on the base of the cross section, is approx. half the length of the arc length of the respective gap (33) between two adjacent longitudinal webs (32).

An elastic rubber stopper (40) sits on the Luer outer cone (12), cf. Figure 5, said rubber stopper sealing the outer cone (12) in a tight and sterile manner. The rubber stepper (40), which can also be manufactured from a flexible plastic, is divided into two regions: a sealing region (41) ar.d a gripping region (51). The sealing region (41) comprises a tubular section, the outer. and inner walls of which each form at least approximately a frustoconical surface. The inner uuall (48) has a cone angle with a cone angle tapering of 1:1635, ':f. Luer inner cone according to DIN 13090, Part 1. The out.:r wall (46) has a cone angle of approx. 3 degrees, with the imaginary tip of the cone, for example according to Figure 5, being located below the sealing region in the region of the syriige barrel (10). The blind hole recess (42) belonging to the inner wall, cf. also Figure 4, has a base (43) which is curved spherically into the discharge bore (13). If appropriate, e foc example conical pin (44) is integrally formed on the base (43), said pin, bearing tightly in some regions, projecting into the discharge bore (13), cf. the dashed-line illustration in Figure 5.

The blind hole recess (42) projects with approx. one fifth of its length into the adjacent gripping region (51).

The gripping region (51) is substantially in the shape of a conical bolt, on the outer wall (55) of which a multiplicity of gripping webs (56), for example ten gripping webs, are integrally formed.

The outer wall (55) has a cone angle of approx. 5 degrees. The gripping webs (56) have a constant cross section cver their entire length. The cross section is in the shape cf a circular section, the height of which, for example, is one third of the corresponding diameter of the circle. The chord length, which is placed in the cross section base of the gripping webs (56), is approx. three times the length of the arc length of the respective gap between two adjacent gripping webs (56).
The gripping webs (56) are spherically rounded downwards and form an axial collar (57). In the region of the ccllar (57), the outside diameter tapers to the outer wall (46) of the sealing region (41) by approx. 66% of the maximum diameter of the gripping region (51). The gripping region (51) has an upper end surface (52) which is labelled, for example and inter alia according to Figure 7. The end surface :52) is adjoined towards the gripping webs (56) by a circu:.ar edge (53) which protrudes slightly beyond the gripping ttebs (56).
After being placed onto the outer cone (12), the ribber stopper (40) projects with the sealing region (41) fully into the threaded zone (23) of the internal thread adap:er (20), but without touching the base of the threaded zone (23). In the process, the rubber stopper (40) is expanded radially to such an extent that it partially touches individual turns of the thread (24), cf. Figure B. The rubber stopper (40) bears with an increased tension force in the front regioi of the outer cone end, since the wall thickness of the rubber stopper is greater in the gripping region (51) than in the sealing region (41).

The base (43) makes contact here in the axial direction with the upper and surface (18) of the outer cone (12) in a, for example, planar annular surface. In addition, the lower gripping web ends and, if, appropriate, also the collar (57) rest on the upper end surface (21) of the internal thread adapter (20).
According to Figure 2, the safety cap (60) is pulled over the fitted combination, illustrated in Figure 1, comprising the syringe barrel (10), the internal thread adapter (20) and the rubber stopper (40). The initially single-part safety cap (60) comprises a front retaining part (61) and a rear break-off part (81). A break-off zone (97) is located between the two parts (61) and (81).
The safety cap (60), cf. Figure 6, is a cup-shaped body with a base (91), in which the outer walls (63, 83) of the: retaining part (61) and of the break-off part (81), which ouw.er walls are located one behind the other, have a frustocon..cal basic shape. The cone angle of the basic shape is, for e:cample, one degree. The diameter of the outer walls (63, 83) increases at increasing distance from the base (91). On the :)asic shape there are arranged, for example, twelve retaining webs (64, 84) distributed over the circumference. All of the retaining webs (64, 84), which are aligned, for example, in he longitudinal direction of the safety cap (60), have trapezoidal cross sections. Said partially different cross sections likewise taper towards the base (91).

The retaining part (61) has a frustoconical inner gall (68), the cone angle of which is, for example, 1.2 degrees. The inside diameter of the inner wall (68) increases here towards the break-off zone (97). In the region of the lower end surface (78) of the retaining part (61), the inner wall (68) has a partially encircling latching web (71), of. also Figures 10 and 11. The radially inwardly protruding latching web (71) has a push-on flank (72) and a retaining flank (73).
The push-on flank (72) has a cone angle of 40 degrees. The imaginary tip of the cone lies in the region of the break-off zone (97). The retaining flank (73) has a cone angle of 120 degrees. The imaginary tip of said cone lies in the region of the lower end surface (78).

In the lower region, the outer wall (63) of the retaining part (61) has a step (65) of smaller wall thickness. Ir the longitudinal direction, the step (65) is of a length which corresponds to approx. 33% of the outside diameter there. Said outside diameter is approx. 6% smaller than the diameter of the adjacent outer wall (63). By means of the reduction in wall thickness, by approx. 46%, the retaining part (61) has a greater degree of elasticity in the region of the Latching web (71) than in the rest of the retaining part (61). the step (65) which tapers towards the lower end surface (73) has a cone angle of two degrees.

The retaining part (61) is of a length which is greater than the average diameter of the retaining part (61) by the factor of approx. 1.13.
According to Figures 10 and 11, the inner wall (68) has two inner webs (75, 86) which extend, for example, over the entire length of the safety cap (60). Said inner webs are interrupted in the break-off zone (97) and in the break-off part (81) by apertures (85) there, cf. Figure 7. The inner webs (75, 86) begin at the lower end surface (78). They are bevelled in a roof-shaped manner there in the circumferential direction, cf.
also Figure 5. The inner webs (75, 86) each have a trapezoidal cross section, cf. Figures 7 and 8. The web width is approximately half the width of the gao (33) between the longitudinal webs (32) of the internal thread adapter (20).
The mutually opposite inner webs (75) are at a clear distance which is always slightly larger than the outside diameter of the outer wall (31) of the internal thread adapter (20).
The break-off part (81) has a frustoconical inner wall (88) which has a cone angle of two degrees. The inside diameter of said inner wall (88) tapers towards the base (91). In the outer wall (83), four at least approximately rectangular apertures (85) are located between the retaining kebs (64), cf. Figures 2, 9 and 11. Said apertures are each located in pairs next to each other while the pairs lie opposite each other. The length of the apertures (85) is at least 60% of the length of the break-off part (81). According to Figure 2, the apertures (85) are located by more than 50% in front of the rubber stopper (40). In the exemplary embodiment, the 2.
apertures (85) together have an area of 52 mm 5 The base (91) likewise has two apertures (92). Each aperture is in the shape of a part of a circular ring. They lie mirror-symmetrically with respect to a plane positioned of the centre line (5). Their two opening cross sections togethe: have an area of 4.9 mm2 A conical retaining pin (93) which is stiffened la:erally by two mutually opposite triangular supporting webs O5) is located between the two apertures (92). The suppor:ing webs (95) are supported between the apertures (92) on tie base (91). They do not reach as far as the lower free end of the retaining pin (93). The retaining pin (93) is of a length which corresponds, for example, to 64% of the average inside diameter of the break-off part (81). Its free end surface (94), with which it rests, when fitted, on the rubber stopper (40), has an area of at least 3.6 mm2.

The break-off part (81) is of a length which is larger than the average diameter of the break-off part (81) by the factor of approx. 1.2. Said length corresponds to the average thicknessof an index finger.

At least three break-off webs (98) are located between the lower end surface (96) of the break-off part (81) and the upper end surface (62) of the retaining part (61). There are four of them in the present exemplary embodiment. Each break-off web (98) is of the shape of an inclined truncated pyramid, with the base surface of the truncated pyramid lying on the lower end surface (96) of the break-off part (81), cf.
Figures 5, 6, 2, 10 and 11. The surface of the rocf of the truncated pyramid - i.e. the transition surface to the retaining part (61) - is approx. one quarter of th? base surface of the truncated pyramid.

Next to in each case two mutually opposite break-off webs (98), cf. Figure 2, there are two supporting pins (99), which are integrally formed on the break-off part (81), of the size of the break-off webs (98). However, said supporting pins (99) do not touch the upper end surface (62) of the retaining part (61). In the unloaded state, they are at a distance of approx.
0.3 mm from the retaining part (61).

In order to produce the tamperproof seal, the internal thread adapter (20) is first of all pushed onto the outer cone (12) is of the syringe barrel (10) in such a manner that its adapter base (27) latches into the annular channel (17). The internal thread adapter (20) now sits on the syringe barrel (10) in a manner such that it is freely rotatable about tie centre line (5). The rubber stopper (40) is pushed onto the outer cone (12) until its blind hole base (43) rests on the end surface (18) of the outer cone (12). In a final step, the safety cap (60) is placed over the rubber stopper (40) and tle internal thread adapter (20). In the process, the two inner webs (75) of the safety cap (60) enter the corresponding gags (33) of the internal thread adapter (20). At the end of tl-e pulling-over movement, the retaining pin (93) is positioned centrally on the rubber stopper (40) and, virtually at the carne time, the latching web (71) latches with its retaining flank (73) behind the lower end side (78) of the internal thread adapter (20). The safety cap (60) now sits captively and ron-releasably on the syringe barrel (10). The tamperFroof seal is produced.

The break-off zone (97) is now located approx. 1 uui below the upper end surface (21) of the internal thread adap':er (20) and approx. 2.7 mm below the upper end side (18) of thou outer cone (12), cf. Figure 5.
In order to open the syringe barrel (10), first of all the break-off part (81) of the safety cap (60) has to )e torn off for releasing purposes. For this purpose, the breac-off part (81) is held in the manner of pincers between the rhumb and the index finger and is loaded towards the side, ci. Figure 3.
If the bending torque exceeds, for example, 25 Ncm, the break-off webs (98) positioned in the pulling zone to which the load is applied start to tear off first. As soon as one break-off web (98) has been torn off, the remaining webs alsD follow.
Since the rubber stopper (40) does not bear against the break-off part (81), it is not released from the outer cDne (12), not even if it is temporarily deflected by an angle of up to degrees during the breaking off of the break-off part (81).
20 The rubber stopper (40) is only pulled off if the NRT
cartridge is to be used. Until then, it remains sealed in a sterile manner.

In order to pull off the rubber stopper (40), the latter can also be pressed elastically to the aide. In the process, it is supported on one side by its collar (57) and/or the lower ends of the gripping webs (56) on the upper end surface (21) of the internal thread adapter (20), which makes it considerably easier to pull it off.
After the rubber stopper (40) has been pulled off, the assembly comprising the retaining part (.61) and the internal thread adapter (20) can rotate freely on the syringe barrel (10), which makes it possible to attach infusion i:istruments, for example, without rotating the syringe barrel (l0) itself.
The syringe barrel (10), the internal thread adapt:r (20) and the safety cap (60) are manufactured for example from plastic.
In this case, each component (10, 20, 60) can be produced from a specific material.

In the above text, the terms "at the top" and "at the bottom"
are used repeatedly. They relate to the orientation of the component as illustrated in each of Figures 1 to 6. What is at the top in said drawings is also at the top of the component.

List of reference numbers:

Centre line Syringe barrel 11 Barrel base 12 Outer cone, Luer outer cone, conical adapter part 13 Discharge bore 14 Truncated cone section 17 Annular channel, conical adapter part 18 End surface, at the top Internal thread adapter, conical adapter part 21 End surface, at the top, at the front 22 Stepped bore 23 Threaded zone 24 Internal thread 26 Bore section, at the front 27 Adapter base 28 Bore 29 Bore section, at the rear 31 Outer wall 32 Longitudinal webs 33 Gaps 38 End surface, at the rear, at the bottom 40 Rubber stopper 41 Sealing region 42 Blind hole recess, conical 43 Blind hole base, base 44 Pin 46 Outer wall 48 Inner wall 51 Gripping region 52 End surface, at the top 53 Edge, radial, at the top 55 Outer wall 56 Gripping webs 57 Collar, axial 60 Safety cap 61 Retaining part 62 End surface, at the top 63 Outer wall 64 Retaining webs, on the outside; structure 65 Step 68 Inner wall 71 Latching web 72 Push-on flank 73 Retaining flank 75 Inner web 76 Bevel, double-sided, roof-shaped 78 End surfaces, at the bottom 81 Break-off part 82 End surface, at the top 83 Outer wall 84 Retaining webs, on the outside 85 Apertures 86 Inner web 88 Inner wall 89 Interior 91 Base 92 Apertures 93 Retaining pin 94 End surface at the free end of (93) 95 Supporting webs 95= End surfaces, at the bottom 97 Break-off zone 98 Break-off webs 99 Supporting pin

Claims (14)

1. Tamperproof seal for a container or a syringe, with a lockable conical adapter which is sealed in a sterile manner by means of a rubber stopper (40) and is protected by a safety cap (60), wherein the safety cap (60), which is pushed non-releasably onto the conical adapter lock, comprises a retaining part (61), a break-off part (81) and a break-off zone (97) located between said parts (61) and (81), characterized - in that the break-off part (81) surrounds the rubber stopper (40) without radial contact, - in that the break-off part (81) has a retaining pin (93), the free end of which rests axially on the rubber stopper (40) - when the tamperproof seal is fitted, - in that the break-off part (81) has at least two open apertures (85, 92), and - in that the length of the break-off part (81) corresponds to at least twice the length of the internal thread (24) of the conical adapter lock.
2. Tamperproof seal according to Claim 1, characterized in that the lockable conical adapter comprises an outer cone (12) and an internal thread adapter (20) which can be fitted behind the outer cone (12).
3. Tamperproof seal according to Claims 1 and 2, characterized in that the retaining pin (93) has a diameter which is smaller than the inside diameter of the discharge bore (13) of the outer cone (12).
4. Tamperproof seal according to Claim 1, characterized in that the retaining pin (93) is of a length which corresponds to at least 0.4 times the length of the break-off art (81).
5. Tamperproof seal according to Claim 3, characterized in that the retaining pin (93) is in the shape of a truncated cone and is flanked by two mutually opposite supporting webs (95).
6. Tamperproof seal according to Claim 1, characterized in that the rear region of the interior (89) of the break-off part (81), in which the retaining pin (93) is located, takes up at least 40% of the entire interior volume of the break-off part (81).
7. Tamperproof seal according to Claim 1, characterized in that the break-off part (81) has in each case at least one aperture (85, 92) in its radial outer wall (83) and on its base (91), with the sum of the cross sections of all of the apertures (85, 92) corresponding to at least ten times the bore cross section of the discharge bore (13).
8. Tamperproof seal according to Claim 1, characterized in that the outer wall (63) of the retaining part (61) has a structure (64) at least in some regions.
9. Tamperproof seal according to Claim 1, characterized in that the apertures (85) of the radial outer wall (113) extend in the longitudinal direction and are of a length which corresponds to at least 60% of the length of the break-off part (81).
10. Tamperproof seal according to Claim 1, characterized in that the internal thread adapter (20) is arranged in a form-fitting manner at the rear end of the outer cone (12) in the longitudinal direction of the conical adapter.
11. Tamperproof seal according to Claim 1, characterized in that there is an encircling annular channel (17) for the form-fitting fastening of the internal thread adapter (20) to the rear end of the outer cone (12).
12. Tamperproof seal according to Claim 1, characterized in that four break-off webs (98) are arranged in the break-off zone (97) between the retaining part (61) and the break-off part (81).
13. Tamperproof seal according to Claim 12, characterized in that each break-off web (98) is of the shape of ar inclined truncated pyramid, with the base surface of the truncated pyramid lying on the break-off part (81).
14. Tamperproof seal according to Claim 12, characterized in that the break-off webs (98) on the retaining part (61) tear off if the bending torque acting on the break-off part (61) is greater than 25 ~ 10 Ncm.
CA2717195A 2008-03-07 2009-02-24 Tamperproof seal with a retaining pin Abandoned CA2717195A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102008013198A DE102008013198B4 (en) 2008-03-07 2008-03-07 Tamper evident closure with retaining pin
DE102008013198.9 2008-03-07
PCT/EP2009/001290 WO2009109312A1 (en) 2008-03-07 2009-02-24 Tamper-proof closure having a retaining pin

Publications (1)

Publication Number Publication Date
CA2717195A1 true CA2717195A1 (en) 2009-09-11

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CA2717195A Abandoned CA2717195A1 (en) 2008-03-07 2009-02-24 Tamperproof seal with a retaining pin

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US (1) US20110015578A1 (en)
EP (1) EP2262560A1 (en)
JP (1) JP2011513147A (en)
KR (1) KR20100138905A (en)
CN (1) CN101959551A (en)
CA (1) CA2717195A1 (en)
DE (1) DE102008013198B4 (en)
TW (1) TW200950840A (en)
WO (1) WO2009109312A1 (en)

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EP2262560A1 (en) 2010-12-22
DE102008013198A1 (en) 2009-09-10
WO2009109312A1 (en) 2009-09-11
KR20100138905A (en) 2010-12-31
JP2011513147A (en) 2011-04-28
CN101959551A (en) 2011-01-26
TW200950840A (en) 2009-12-16
DE102008013198B4 (en) 2011-07-14
US20110015578A1 (en) 2011-01-20

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