Security seal for medical sterile container

Abstract

A security seal for a medical container includes a seal foot having at least one latch structure movable relative thereto for engaging a mating latch structure formed on the container, and a seal head connected with the seal foot that includes at least one locking tab which is movably connected with the seal head through a hinge element, wherein the security seal includes a bolt element which can be positioned between a release position, in which the latch structure can be moved relative to the seal foot, and a locked position, in which the deformable latch structure is fixed in position relative to the seal foot and/or seal head.

Claims

1. A security seal for a medical container, the security seal comprising: a seal foot having a substantially circular cross-section and having at least one latch structure movable relative to the seal foot for engaging a mating latch structure formed on the medical container, and a seal head connected with the seal foot and comprising at least one locking tab which is movably connected with the seal head through a hinge element, the security seal comprising a bolt element which can be positioned between a release position, in which the at least one latch structure can be moved relative to the seal foot, and a locked position, in which the at least one latch structure is fixed in position relative to the seal foot, wherein the seal foot comprises at least two spring arms extending from the seal head, each of said at least two spring arms having a distal end provided with a latching protrusion, the latching protrusions protruding radially outwardly, wherein the at least two spring arms are each formed as a partial cylinder and arranged around a through-hole which is formed in the seal head and fully penetrates the seal head, the through-hole serving to receive and guide the bolt element.

2. The security seal according to claim 1, wherein the bolt element has a bolt-like design and is arranged so as to be able to be positioned in the direction of its longitudinal axis relative to at least one of the seal head and the seal foot.

3. The security seal according to claim 1, wherein the bolt element is supported on or in a through-hole formed in at least one of the seal head and seal foot.

4. The security seal according to claim 1, wherein the bolt element in its locked position fixes the at least one latch structure.

5. The security seal according to claim 1, wherein the bolt element is connected with at least one of the seal head and the seal foot in the release position via predetermined breaking points and is held in its axial position, said predetermined breaking points being destroyed when transferring the bolt element from the release position to the locked position.

6. The security seal according to claim 1, wherein at least one contact shoulder extending in a radial direction is formed on the bolt element, said at least one contact shoulder engaging a mating contact shoulder formed on at least one of the seal foot and the seal head during transfer of the bolt element to the locked position, so that any movement of the bolt element from the locked position back to the release position is prevented.

7. The security seal according to claim 1, wherein the at least one latch structure comprises the latching protrusions.

8. The security seal according to claim 1, wherein the at least one latch structure comprises a plurality of radially opposite latch structures which are positioned at equal angular distances.

9. A system comprising a medical container and a security seal according to claim 1.

10. The system according to claim 9, wherein when the at least one latch structure is in a non-deformed state and arranged on the container as intended, the security seal engages the mating latch structure in an undetachable manner and can be elastically deformed from the non-deformed state for arranging it as intended.

11. The security seal according to claim 1, wherein an end of the bolt element facing the seal foot has a star-shaped end structure comprising a plurality of tips, the tips of the star-shaped end structure resting against inner surfaces of the at least two spring arms and preventing radially inward deformation of the at least two spring arms in the locked position.

12. The security seal according to claim 1, wherein the bolt element comprises a bolt head and a bolt shaft, the bolt shaft beinq provided with a pocket incorporated in a radial direction in the bolt shaft, circumferentially surrounding the bolt shaft in part and discontinued by two axial grooves, and wherein each of the spring arms has its radially inner side provided with a latching protrusion which serves for engaging the pocket.

13. The security seal according to claim 1, wherein the bolt element comprises a bolt head and a bolt shaft, the bolt shaft being provided with a pocket incorporated in a radial direction in the bolt shaft, circumferentially surrounding the bolt shaft in part and discontinued by two axial grooves, and wherein the through-hole has two areas which protrude radially inwards and engage the axial grooves and guide the bolt element when the bolt element is inserted in the through-hole.

14. The security seal according to claim 1, wherein the bolt element comprises a bolt head and a bolt shaft, the bolt shaft being provided with a pocket incorporated in a radial direction in the bolt shaft, circumferentially surrounding the bolt shaft in part and discontinued by at least one axial groove.

15. A security seal for a medical container, the security seal comprising: a seal foot having a substantially circular cross-section and having at least one latch structure movable relative to the seal foot for engaging a mating latch structure formed on the medical container, and a seal head connected with the seal foot and comprising at least one locking tab which is movably connected with the seal head through a hinge element, the security seal comprising a bolt element which can be positioned between a release position, in which the at least one latch structure can be moved relative to the seal foot, and a locked position, in which the at least one latch structure is fixed in position relative to the seal foot, wherein the bolt element comprises a bolt head and a bolt shaft, the bolt shaft being provided with a pocket incorporated in a radial direction in the bolt shaft, circumferentially surrounding the bolt shaft in part and discontinued by at least one axial groove.

Description

BRIEF DESCRIPTION OF THE DRAWING FIGURES

(1) Further features and advantages of the present invention will be apparent from the following exemplary and non-limiting description of the invention as well as from a particularly preferred embodiment on the basis of Figures which are merely of schematic nature and only serve for the understanding of the invention. In the Figures:

(2) FIG. 1 shows an embodiment of the security seal in a perspective illustration,

(3) FIG. 2 shows the embodiment of FIG. 1 in an enlarged perspective partial view,

(4) FIG. 3 shows the embodiment of FIG. 1 in another enlarged perspective partial view,

(5) FIG. 4 shows the security seal in the unlocked state, arranged on a sterile container,

(6) FIG. 5 shows the security seal in the unlocked state, arranged on a sterile container as seen from the seal foot,

(7) FIG. 6 shows the security seal in the locked state, arranged on a sterile container,

(8) FIG. 7 shows the security seal in the locked state, arranged on a sterile container as seen from the seal foot,

(9) FIG. 8 shows the security seal in the broken state, arranged on a sterile container after having opened the latter,

(10) FIG. 9 shows the security seal in the broken state, arranged on a sterile container after having opened the latter and during the attempt to close the container again,

(11) FIG. 10 shows the process of removing the security seal after having opened the containers at two successive points in time,

(12) FIG. 11 is a perspective view of a one-piece security seal,

(13) FIG. 12 is a perspective view of a two-piece security seal, and

(14) FIG. 13 shows a sterile container comprising a security seal according to the invention in a perspective view.

DETAILED DESCRIPTION

(15) A security seal 1 according to the invention comprises a seal foot 2, a locking bolt 3 and a seal head 4. The entire security seal 1 is made of plastic in one piece by injection-molding. In FIGS. 1 to 5, the security seal 1 is shown in its original state, i.e. before sealing a container. The FIGS. 6 and 7 show the security seal 1 in a state when it is inserted in a sterilization container 100 to be sealed. FIGS. 8 and 9 show the security seal 1 after having opened the container 100 and FIG. 10 finally shows it during removal therefrom.

(16) By means of two hinge elements 7, 8, two locking tabs 5, 6 are movably arranged on the seal head 4. The locking tabs 5, 6 are opposite each other in radial direction. In the embodiment illustrated, the security seal 1 is designed to be mirror-symmetric. The hinge elements 7, 8 are laterally formed on the seal head 4.

(17) When the security seal 1 is opened, said hinge elements are deformed. If the hinge elements 7, 8 are bent beyond a certain amount, they are subject to a plastic deformation which results in irreversible changes of the material up to a so-called stress whitening. The degree of the banding or deformation as from which the plastic deformation and/or the stress whitening of the hinge elements 7, 8 occurs, depends on their dimensions, in particular on the height and width of the hinge elements 7, 8 as well as on the material properties.

(18) The seal foot 2 comprises two spring arms 9a, b extending from the seal head 4. Each of said spring arms has its distal end provided with a latching protrusion 10, 11 which are opposite each other in radial direction and protrude radially outward. The latching protrusions 10, 11 protrude with respect to the seal foot 2 in the same directions as the locking tabs 5, 6 with respect to the seal head 4.

(19) The seal head 4 has an essentially rectangular cross-section. The two locking tabs 5,6 and the associated hinge elements 7, 8 likewise result in a substantially rectangular cross-section. In addition, each locking tab 5, 6 protrudes radially with respect to the seal foot 2 and the seal head 4,

(20) Formed on the seal head 4 are two protrusions 12, 13 which project laterally from the seal head 4. They extend along the longer side of the substantially rectangular seal head 4 and each form a supporting area 14 which rests against the side of the locking tabs 5, 6 facing the seal foot 2. Here, a thin material connection may be present which protects the locking tabs 5, 6 from any unintentional actuationfor instance during transport or inserting it into the containerand breaks in case of a larger forcenamely from the locking tab. This version is much easier to produce, as the process of demolding the seal 1 after injection-molding is considerably simplified.

(21) Formed in the seal head 4 is a through-hole 17 which is illustrated in FIG. 2, for example. The through-hole 17 fully penetrates the seal head 4 in the axial direction and serves for receiving and guiding the locking bolt 3 so as to be positionable in the axial direction. Said locking bolt substantially consists of a bolt shaft 18 and a bolt head 19 which is arranged on the end of the bolt shaft 18 opposite the through-hole 17. The bolt head 19 is provided with a receiving pocket 20 for an indicator which is not shown.

(22) The bolt shaft 18 is provided with pockets 21 which are spaced from each other in the axial direction and are incorporated in the radial direction in the bolt shaft 18 circumferentially surrounding it in part and so as to be discontinued by two axial grooves 32 which are described in more detail below. The pockets 21a which have the lowermost position in FIG. 1 (those which are closest to the seal foot 2) and are opposite each other serve as latch structures for latching protrusions 22 of the spring arms 9a, b explained below. As seen in cross-section, the lateral surface of said pockets 21a which faces the seal foot 2 is designed with a steep angle with respect to the longitudinal axis of the locking bolt 3, inclined with respect to the longitudinal axis at an angle between roughly 80 and 100, preferably 90. The opposite lateral surface may have a slight inclination. The lowermost pockets 21a, i.e. those which are ahead if the locking bolt 3 is inserted, serve for securing the locking bolt 3 in the fully inserted state or its end position. The pockets 21b which are further up in FIG. 1 or have a larger distance from the seal foot 2 are optional, however, and can cooperate with corresponding latch structures (not shown in more detail) in the seal head 4 and haptically indicate an intermediate latching process. These pockets 21b preferably have a round cross-section and allow the locking bolt 3 to engage and disengage in both directions before reaching the final locking position.

(23) As illustrated in particular in FIG. 2, the end of the locking bolt 3 facing the seal foot 2 has a star-shaped design. In the original state, i.e. when the security seal 1 is unused, the locking bolt 3 is held on the seal head 4 by means of material webs 23 which are formed between the tips of its star-shaped end and the wall of the through-hole 17. In other words, the security seal 1 is realized in one piece, in particular a one-piece injection-molded part. Such a one-piece seal 1 is shown in FIG. 11. The material webs 23 are implemented as predetermined breaking points which indeed hold and fix the locking bolt 3 in its original position with respect to the seal head 4; in the event of a user-side actuation in which the locking bolt 3 is axially shifted toward the seal foot 2, however, these material webs will break and release the locking bolt 3. As an alternative, the seal 1 may have a two-piece design, i.e. it may consist for instance of a separate seal body made up of seal head 4 and seal foot 2, on the one hand, and of a separate locking bolt 3 on the other hand. Such a security seal 1 is shown in FIG. 12.

(24) It can be taken from FIG. 2 that the spring arms 9a, b having their distal ends provided with the latching protrusions 10, 11 are formed like a partial cylinder and arranged around the through-hole 17. This is why the locking bolt 3 can be inserted through the through-hole 17 into the gap between the spring arms 9a, b. Each of the spring arms 9a, b has its radially inner side provided with a latching protrusion or mating contact shoulder 22 which serves for engaging the corresponding pocket 21a during actuation of the seal, i.e. when the locking bolt 3 is inserted toward the seal foot 2. During inserting the locking bolt 3 into the through-hole 17, the former advances in the axial direction with a concomitant elastic expansion of the spring arms 9a, b in radial outward direction. If the pockets 21a reach the axial position of the latching protrusions 22, the spring arms 9a, b spring back due to their elasticity, and the latching protrusions 22 engage the pockets 21. This latching process can be perceived by the operator during locking the security seal 1. Due to the steep flank of the pockets 21a which is near the seal foot, pulling out the locking bolt 3 is not possible any longer as from this point in time, as the latching protrusions 22 cannot slide over the steep flanks and the locking bolt 3 is blocked in this direction by the engagement of the latching protrusions 22 in the pockets 21. The latching protrusions 22 latch in place in the pockets 21a only in the end position of the locking bolt 3. If the locking bolt 3 is inserted, a deformation of the spring arms 9a, b into the gap which is present between them is not possible, as the spring arms 9a, b have their inner surfaces abutting against the locking bolt 3.

(25) The process of sealing a sterilization container 100 will be explained now with reference to FIGS. 4 to 7. The sterile container 100 comprises a container closure 24 which is substantially formed from a first closure part 25 and a second closure part 26. The second closure part 26 can be moved between an open position and a closed position relative to the first closure part 25, in particular can be swiveled. For the purpose of opening the sterile container 100, the first closure part 25 has to be swiveled away from the second closure part 26. If the closure 24 is closed, the two closure parts 25, 26 rest against each other more or less.

(26) The first closure part 25 has a seating 27 where the spring arms 9a, b of the seal foot 2 can latch in place. FIG. 5 shows the spring arms 9a, b of a security seal 1 arranged on the sterile container 100, as seen from the container 100. The second closure part 26 comprises a through-hole 31 through which the spring arms 9a, b have to be put during insertion in the seating 27 of the first closure part 25.

(27) The sterile container 100 is closed by means of the closure 24 and the two closure parts 25, 26 are swiveled relative to each other. The security seal 1 is arranged on the container 100 by inserting it from the outside toward the container 100 through the through-hole 31 into the seating 27. In doing so, the spring arms 9a, b pass through the seating 27 such that the latching protrusions 10, 11 engage behind its surrounding edge and fix the security seal 1 on the closure 24 and hence on the container 100. On the side of the container, the latching protrusions 10, 11 are each provided with a starting bevel 28 which can be clearly seen in FIG. 5. During arranging the seal 1 on the container 100, the starting bevel 28 comes into contact with the edge of the seating 27. The spring arms 9a, b are deflected radially inwards with a continued insertion of the seal toward the container 100 until the latching protrusions 10, 11 have moved past the edge of the seating 27, and then spring back in elastic fashion to their original position, engaging behind the edge. FIG. 5 shows the seal 1 in the state in which it is fully slipped onto the closure 24. As can be taken from FIG. 4, the locking bolt 3 is still in its original position at this point in time, i.e. a position in which it is not advanced into the through-hole 17 of the seal head 4, and is secured by means of the material webs 23.

(28) In the further course of sealing the container 100, the locking bolt 3 is pushed into the seal head 4 toward the container 100 and the seal foot 2. Due to the pressure which is exerted on the bolt head 19 by the user, the material webs 23 realized as predetermined breaking points will break. The bolt shaft 18 is pushed through the through-hole 17 and reaches the gap between the two spring arms 9a, b which are in their original position after the latching of the latching protrusions 10, 11. During insertion of the locking bolt 3 into the through-hole 17, the latching protrusions 22 provided on the inner surfaces of the spring arms 9a, b slide over the bolt shaft 18 of the locking bolt 3, and the spring arms 9a, b are slightly deformed radially outwards. In the further course of the insertion process, they engage the pockets 21a on the bolt shaft 18. In the state fully inserted in the seal head 4, which is shown in FIGS. 6 and 7, the bolt head 19 rests flush on the seal head 4. The bolt shaft 18 inserted through the through-hole 17 between the spring arms 9a, b to such an extent that the tips of its star-shaped end structure rest against the inner surfaces of the spring arms 9a, b and prevent their radially inward deformation. As a result, the locking bolt 3 is blocked by the engagement of the protrusions 22 in the pockets 21a, whereas the spring arms 9a, b are blocked by the locking bolt in the position latched in place in the seating 27. Without opening the closure 24, the seal 1 cannot be detached from it and from the container 100. In order to prevent any unintentional axial twisting of the locking bolt 3 with respect to the through-hole 17, the bolt shaft 18 is provided with two axial grooves 32 and the through-hole 17 has two areas 33 which protrude radially inwards and engage the grooves 32 and guide the locking bolt 3 when the locking bolt 3 is inserted into the through-hole 17. At the very beginning of the insertion operation, the material webs 23 serve as anti-rotation means, too.

(29) The seating 27 has such a design that it has areas, for example, in the form of its edges which are able to produce undercuts with the latching protrusions 22 of the seal foot 2. In this exemplary embodiment, these are two arcuate portions 29 (clearly visible in FIG. 10) which delimit the seating 27 laterally. Formed between the arcuate portions 29 are two open recesses 30, to be seen in FIG. 7. These have such a design that the latching protrusions 22 are able to move past the spring arms in both directions, i.e. toward the container 100 or away from the container 100. For the purpose of removing the security seal 1 from the seating 27, the container 100 or the closure 24 has to be opened first, whereby the seal 1 is devaluated. If the closure 24 is open, it can then be rotated in the seating 27 around its longitudinal axis, in particular by 90, until the latching protrusions 22 overlap with the free recesses 30 and the security seal 1 can be pulled out of the seating 27.

(30) If the security seal 1 is fully inserted (see FIGS. 6 and 7), the seal head 4 is situated in the through-hole 31 in form-locking fashion, so that the security seal 1 cannot be rotated with respect to the closure 24. As a consequence, the protrusions 22 cannot be removed from the recess 27 in the above-described manner without opening the closure 24. Moreover, the security seal 1 is completely embedded in the second closure part 26 and is flush with it, whereby it is protected against accidental damage.

(31) The security seal 1 according to the invention is supposed to ensure that the safety closure 24 and hence the container 100 cannot be opened without devaluating the security seal 1. The devaluation of the security seal 1 is brought about in that its locking tabs 5, 6 are bent apart due to the contact with the second closure part 26 during opening the closure 24. This results in irreversible, preferably plastic deformation of the locking tabs 5, 6 and/or the hinge elements 7, 8 which has already been described above. The locking tabs 5, 6 are bent up so far until they fit through the through-hole 31 of the second closure element 26. With the locking tabs 5, 6 being bent open, the second closure part 26 moves past the seal head 4, so that the closure 24 can be opened with a concomitant devaluation of the security seal 1. This state is illustrated in FIG. 8. Any re-closing of the closure 24 is not possible without completely removing the security seal 1 from the container 100, as the bent-up locking tabs 5, 6 cannot be moved through the through-hole 31 in the opposite direction (see FIG. 9).

(32) The security seal 1 according to the invention can be used in combination with a closure 24, for instance on a sterile container 100 as shown in FIG. 7 and comprising a container trough 101 and a lid 102. The first closure part 25 may be provided on the container trough 101 and the second closure part 26 on a closure tab which is articulated on the lid 102 of the container 100. The container 100 is of symmetric design and has its two end faces provided with one closure 24 each. For opening the container 100, i.e. for lifting off the lid 102 from the container trough 101, the two closure tabs articulated on the lid 102 are swiveled open, so that the second closure part 26 is moved away from the corresponding first closure part 25 in a pivoting manner.

(33) The significant advantages of the security seal 1 according to the invention can be summarized as follows: The reuse of the security seal 1 after opening the sterile container is safely prevented. The bolt head 19 offers a large and clearly visible area for an indicator. The configuration allows a good visual check of the intactness of the seal. During locking of the seal, the operator feels when the locking bolt 3 locks in place. The security seal 1 can only be locked if it is in the correct position. The locking bolt 3 helps in the positioning and handling of the security seal 1. The security seal 1 is fully embedded in the front plate of the second closure part 26 and in this way is protected against accidental damage. The security seal 1 can be set and locked in a one-hand actuation. It is not possible to open the lid 102 without devaluating the security seal 1. Once devaluated, the security seal 1 is irreparable, as the locking bolt 3 is latched in place and all connections are destroyed. The security seal 1 does not fall off from the container 100 when the lid 102 has been removed.