Protective device for a needle tube of a syringe

Description

Description

[0001] The present application relates to a protective device for a needle tube of a syringe according to the preamble of claim 1. Furthermore, the present application relates to a set comprising a protective device and a needle carrier with a needle tube mounted therein.

[0002] The protective device comprises a base and a cover connected to the base. The cover is pivotable relative to the base, with the base and cover typically connected by a foil hinge. The base is designed to interact positively with a needle carrier. The needle carrier is designed to support the needle tube. The needle tube is typically bonded centrally into a recess in the needle carrier, forming a force-transmitting connection between the needle tube and the needle carrier. Due to the positive connection between the base and the needle carrier, the base is generally rigidly attached to the needle carrier.

[0003] The cover is elongated and extends along a longitudinal axis. It encloses an interior space in which the needle tube can be stored, protecting a person from accidental contact. Specifically, it is designed to prevent unintentional contact with the needle tip of the needle tube, particularly after using it for injections. This helps prevent the transmission of infectious diseases from a patient who has been pricked with the needle tube to a person treating that patient.

[0004] The cover is pivotable relative to the base in such a way that it can be moved within a pivot plane relative to the base. This allows the cover to be moved from an initial position, in which the needle tube is stored inside the cover before injection, into a working position relative to the base. In the working position, the needle tube is released for injection use, meaning it is no longer located inside the cover. After injection, the cover can be moved back into a protective position in a second pivot direction opposite to the first, in which the needle tube is again stored inside the cover.This protects the needle tube from unintentional contact with a person after injection use as described above.

[0005] To allow the needle tube to exit the cover when it is moved from the initial position to the operating position, and then re-enter the cover when it is moved back from the operating position to the protective position, the cover is open on one side in the pivot plane. Specifically, a wall of the cover that spatially encloses the interior of the cover can only enclose the interior on three sides, while the fourth side remains open.

[0006] The cover has an internal retaining device that allows the needle tube to be positively locked in place when the cover is moved into its protective position. This is achieved in such a way that, once the cover is in its protective position, the needle tube cannot unintentionally protrude from the interior. In other words, the retaining device serves to "hold back" the needle tube, so that a subsequent pivoting of the cover relative to its base after the needle tube has been used for injection will not release the needle tube. State of the art

[0007] A protective device of the type described above is already known in the prior art. Reference is first made to international patent application WO 2021 / 008717 A1. This application describes a protective device whose cover has a retaining device for securely holding the needle tube. The retaining device comprises two tabs that extend opposite each other from an inner surface of a wall of the cover. The tabs are inclined relative to the pivot plane and are elastic enough that the needle tube can deform the tabs, thereby displacing them and thus engaging behind them.This ensures that the needle tube cannot exit the safety area behind the tabs if the cover pivots relative to the base of the protective device, thus preventing unintentional injury to a person by the needle tube.

[0008] Although the safety of the known protective device against unintentional exit of the needle tube from the safety area is already very high, deliberate misuse of the protective device is conceivable, which could lead to the needle tube exiting the safety area after its use in injection and thus posing a risk of infection.

[0009] Reference is also made to US Patent 5,490,841 B1, which likewise discloses a protective device with a cover. The cover comprises a retaining device, which in turn includes a tab oriented obliquely within an interior space of the cover. The tab serves to securely "enclose" a needle tube in a securing area of ​​the interior of the cover after its injection use. The tab is designed to be flexible enough to allow the needle tube to initially deform elastically to enter the securing area. Deformation in the opposite direction, which could lead to the needle tube exiting the securing area, is prevented by a stop formed at a point on an inner surface of the cover wall opposite the tab.

[0010] The described design is disadvantageous insofar as the tab extends within the interior of the cover in such a way that a collision between the tab and the needle tube can occur before the injection is used. This is particularly disadvantageous with regard to the automated production of a syringe equipped with a needle holder, needle tube, and a protective device, since the protective device cannot be easily mounted on or to the needle holder without the needle tube, which is supported by the needle holder, colliding with the tab located within the interior of the cover.

[0011] US Patent 5,490,841 A discloses a needle guard device with an elongated housing that includes an elongated needle entry area defined between two housing side walls. A pivoting trapdoor is provided that extends across the entry area to enclose the needle within the housing. The trapdoor is attached to one end of a side wall by means of a flexible film hinge and extends transversely across the entry area to abut a door stop on the opposite side wall, allowing the trapdoor to pivot around the film hinge toward the first side wall to allow the needle to enter the housing. However, the degree of rotation away from the first side wall is limited by the door stop, thus preventing a needle already inside the housing from exiting through the entry area.

[0012] Furthermore, German patent application DE 10 2017 120 538 A1 discloses a protective device for securing a needle. The protective device comprises a receiving element with a receiving area for receiving the needle. The receiving element has a covering device that forms a cover for the receiving area. The covering device has an entry opening for the needle to penetrate the receiving area. The covering device is movably attached to a side part of the receiving element such that the entry opening enlarges when the needle is pressed against the covering device, allowing the needle to penetrate the receiving area, and the entry opening shrinks again after the needle has entered the receiving area and no pressure is exerted on the at least one covering device.

[0013] Furthermore, US patent 2020 / 0078532 A1 discloses a device for preventing needlestick injuries to an injection needle carried by a needle-bearing element of a syringe. It is designed as a one-piece molded part and comprises a first part that can be attached to the needle-bearing element and a second part that provides protection for the needle and is pivotable relative to the first part to expose the needle for use. The device is designed to assume a first position in which the needle is protected for transporting the device before use. It can also assume a second position in which the needle is exposed for filling the syringe and for injection. Finally, it can assume a third position in which the needle is protected after the syringe has been filled but before injection.Furthermore, it can assume a fourth position in which the needle is locked in the device after injection. Task

[0014] The present application is therefore based on the task of providing a protective device that can be attached to a needle carrier in a particularly simple automated manner and at the same time offers a high level of security against the unintentional escape of the needle tube from the cover after its use in injection. Solution

[0015] The underlying problem is solved according to the invention by means of a method with the features of claim 1. Advantageous embodiments are described in the dependent claims.

[0016] The protective device according to the invention is characterized in that the holding device comprises a deformable tab, a stop associated with the tab, and at least one guide element. The tab is designed to be deformed by the needle tube during the transfer of the cover into its protective position and thereby displaced in a first direction, so that the needle tube can enter a securing area of ​​the interior located behind the tab. The needle tube is thus locked behind the tab, so that the tab retains the needle tube in the securing area and thereby prevents unintentional release of the needle tube. The stop is located opposite the tab on the inner surface of the cover.Its wall is designed and configured so that, in the event of deformation by the needle tube, the tab strikes a lower stop surface of the stop in a second direction opposite to the first, thereby preventing further deformation of the tab. In this way, unintentional exit of the needle tube from the safety area is prevented.

[0017] In its undeformed state, the tab extends from the inner surface of the cover into the interior, with the tab – viewed in a cross-section perpendicular to the longitudinal axis of the cover – forming a tab angle of at least 35° with the pivot plane. Preferably, this angle is at least 40°, and more preferably at least 45°.

[0018] The at least one guide element is associated with the stop and is designed to guide the needle tube located within the safety zone in such a way that, after entering the safety zone, the needle tube is prevented from remaining below the stop's contact surface. In particular, the guide element can block a space below the stop in such a way that the needle tube strikes the guide element laterally and thus cannot enter the space below the stop. In this way, it is prevented that the needle tube, once it has entered the safety zone, moves below the stop and then between the tab and the stop, thereby preventing it from escaping the safety zone.

[0019] The protective device according to the invention has many advantages. In particular, it ensures the secure containment of the needle tube within the cover after the needle tube has been used for injection and the cover has subsequently been pivoted into its protective position. This is because, once the needle tube enters the containment area, which, as described above, requires the temporary displacement of the elastic tab, it can no longer escape from the containment area. Any movement of the needle tube out of the containment area inevitably causes it to collide with the tab from below, elastically deforming the tab once again. However, due to the coordinated geometry of the tab and the stop, this deformation results in the tab striking the stop surface, thus preventing further deformation of the tab.The at least one guide element ensures that the needle tube always abuts the underside of the tab and, in particular, cannot directly strike the stop side of the tab. Tests have shown that even with deliberate manipulation of the safety device, it is impossible to remove the needle tube from the safety area once it has entered it.

[0020] A further advantage is that the protective device can be readily mounted on a needle carrier equipped with a needle tube. This prevents a collision between the needle tube and the cover's tab when it is in its initial position. This is achieved by the tab's relatively steep inclination relative to the pivot plane, which, as described above, is at least 0°. In the prior art, known tabs are inclined at a significantly shallower angle relative to the pivot plane and thus extend essentially centrally through the interior of the cover. However, when the cover is in its initial position, the needle tube occupies this area, so that during the installation of a cover with such a shallower tab, a collision between the needle tube and the tab would likely occur.

[0021] A further advantage of the design according to the invention is that the prevention of the needle tube exiting the secured area is achieved through the interaction of the soft tab and the rigid stop. This allows the tab itself to be designed with a comparatively soft, i.e., low stiffness, since the tab is not solely responsible for securing the needle tube. Therefore, slight deformability of the tab is not detrimental to the desired securing effect, because although the tab can be slightly deformed from the underside upon contact with the needle tube, a "punch-through" of the tab in the opposite direction is prevented by its impact against the stop surface. The slight deformability of the tab also has the particular advantage that the protective device can be used even when a thin needle tube is employed.In particular, needle tubes, such as those used in insulin syringes, can have a particularly small diameter, making them especially deformable. If the tab—as is common in the prior art—were rigid to ensure the needle tube is secured within the locking area, the needle tube would not be able to displace the tab; instead, the tab would deform the needle tube. This would prevent the needle tube from reliably entering the locking area, resulting in a safety deficiency for any syringe equipped with such a protective device. This safety deficiency would not stem from the needle tube unintentionally exiting the locking area, but rather from the needle tube's inability to reliably enter it. A soft tab eliminates this risk.

[0022] In an advantageous embodiment of the protective device according to the invention, viewed in a cross-section of the cover perpendicular to its longitudinal axis, a distance exists between an end of the tab facing away from the inner surface of the cover (in its undeformed state) and an end of the stop facing the tab. This distance is measured in a direction perpendicular to the pivot plane. In other words, in this embodiment, there is a distance between the mutually facing ends of the stop and the tab, measured perpendicular to the pivot plane. This distance is preferably in the range of 0.05 mm to 0.25 mm, and more preferably between 0.10 mm and 0.20 mm. Thus, in this embodiment, the tab, when in its undeformed state, does not extend below the stop surface.Instead, a minimal gap exists between the tab and the stop, facilitating the insertion of the needle tube into the locking area of ​​the cover's interior. In particular, only a slight deformation of the tab is necessary for the needle tube to enter the locking area and snap into place behind the tab. Accordingly, this design is especially advantageous for enabling the insertion of a needle tube into the locking area with minimal force, ensuring both reliable insertion and preventing unintentional deformation of the needle tube.

[0023] Furthermore, such a design of the protective device can be particularly advantageous in which – viewed in a cross-section of the cover perpendicular to its longitudinal axis – there is a distance, measured in a direction parallel to the pivot plane, between an end of the tab facing away from the inner surface of the cover (in its undeformed state) and an end of the stop facing the tab. This distance is preferably in the range of 0.20 mm to 0.80 mm, more preferably between 0.25 mm and 0.70 mm, and even more preferably between 0.30 mm and 0.60 mm. This design also has the advantage that the entry of a needle tube into the locking area is simplified, since the tab only needs to be displaced minimally for the needle tube to snap into place behind the tab.In principle, it would be conceivable that the needle tube could pass through a gap formed between the tab and the stop due to the described distance, thus leaving the safety zone; however, this is prevented by the guide element, which guides the needle tube in such a way that it cannot get under the stop and therefore cannot access the gap. Consequently, any movement of the needle tube in any direction out of the safety zone is necessarily linked to contact with the underside of the tab, leading to the described deformation of the tab until it strikes the stop's contact surface.

[0024] Preferably, the at least one guide element extends from the inner surface of the cover into the interior. This is preferably done in such a way that the space below the stop surface of the needle tube stop is completely blocked. The advantages resulting from this have already been explained above.

[0025] Furthermore, it can be particularly advantageous if the protective device has a plurality of guide elements, wherein preferably – viewed in the longitudinal direction of the cover – at least one guide element is arranged in front of the stop and at least one guide element is arranged behind the stop. This design has the advantage that movement of the needle tube into the space below the stop surface is reliably prevented even if the needle tube is deformed, in particular bent along its longitudinal axis. Thus, the space below the stop surface is "blocked" from both sides of the stop by means of the two guide elements, so that the needle tube cannot reach this space and is consequently reliably held below the tab.

[0026] Further developing the protective device according to the invention, the cover, viewed in a cross-section perpendicular to its longitudinal axis, is formed with a U-shaped wall that spatially defines the interior. The cover is preferably designed such that a vertical axis of its cross-section is oriented parallel to the pivot plane of the cover. In particular, the cover can be formed at least substantially parallel in its cross-section at its opposing inner surfaces, from which the tab extends on one side and the stop on the other. A corresponding embodiment can be seen in the following exemplary embodiment. This is particularly advantageous for ensuring the interaction of the tab and the stop.

[0027] Furthermore, such a design of the protective device can be particularly advantageous in which the base and the cover are connected to each other by means of a predetermined breaking point ("tamper-evident seal") when the cover is in its initial position. The predetermined breaking point can be destroyed by applying manual force, so that the cover can be pivoted into its intended operating position after the breaking point has been destroyed. This design is particularly advantageous for securely storing the needle tube within the cover before its injection use, whereby the predetermined breaking point prevents the cover from accidentally pivoting into the operating position and thus prevents the needle tube from being accidentally released.Furthermore, protecting the needle tube before injection does not require a separate cover, such as a closed cap, placed over it. Instead, the cover alone can fulfill its protective function both before and after injection. This is particularly feasible due to the design of the tab, which is steeply inclined relative to the pivot plane, as described above. This eliminates the risk of the needle tube colliding with the tab when the protective device is mounted on a needle carrier. Moreover, if the predetermined breaking point is damaged, it serves as an indicator that the needle tube may have already been used.A user of the protective device would therefore no longer use a needle tube unless he or she has "opened" the protective device himself or herself, i.e., destroyed the predetermined breaking point.

[0028] In a further advantageous embodiment of the protective device according to the invention, the cover and the base are connected to each other by means of a foil hinge. Such a foil hinge is particularly well suited to enabling the described pivotability of the cover relative to the base, while simultaneously allowing for a one-piece design of the protective device. Therefore, it is particularly advantageous if the protective device is designed as a single piece.

[0029] Furthermore, such a design of the protective device can be particularly advantageous in which the cover and the base are arranged coaxially to each other when the cover is in its initial position. In this design, the longitudinal axes of the base and the cover are consequently oriented parallel to each other. Preferably, the longitudinal axes of the cover and the base coincide.

[0030] Alternatively or additionally, it can be particularly advantageous if, when in its protective position, the cover is pivoted in the second pivoting direction such that the longitudinal axes of the base and the cover are not parallel to each other, i.e., they enclose an angle greater than 0°. This design has the advantage that the needle tube can be brought into contact with the tab particularly easily, thereby displacing the tab as described, so that the needle tube finally enters the securing area of ​​the interior of the cover.In an embodiment where the cover is inclined differently relative to the base between its initial position and its protective position, it is particularly easy to initially prevent a collision between the needle tube and the tab when mounting the protective device on a needle carrier, while deliberately provoking such a collision when moving the cover into the protective position, thus allowing the needle tube to enter the safety zone. Furthermore, the described embodiment is advantageous in that the cover can be attached to the base particularly easily for locking in its protective position, preferably by means of a positive fit.

[0031] Accordingly, it can be particularly advantageous if at least one locking element is provided at the base, designed to engage positively with at least one locking partner of the cover, so that the cover can be locked in the protective position. The interaction of the locking element with the locking partner is particularly easy to achieve by pivoting the cover beyond its initial position relative to the base as it is moved into the protective position, thereby bringing the locking partner of the cover into contact with the locking element of the base. As a result of the engagement of the locking partner with the locking element, it is ensured that the cover is not unintentionally moved from its protective position back to its operating position.

[0032] The underlying problem is further solved according to the invention by means of a set comprising the features of claim 12. An advantageous embodiment is described in the associated dependent claim.

[0033] The set comprises a protective device according to the invention as described above, and a needle holder with a needle tube mounted therein. The base of the protective device is positively connected to the needle holder, so that when the cover is in its initial position, the needle tube is oriented parallel to the longitudinal axis of the cover. By pivoting the cover from its initial position to its operating position in a first pivot direction in the pivot plane, the needle tube can be released for injection use. Subsequently, the cover can be pivoted back towards its initial position in a second pivot direction opposite to the first, so that the needle tube re-enters the interior of the cover and is protected from unintentional contact with a person.As explained above, it can be particularly advantageous if the cover is locked relative to the base when it reaches its protective position, thus preventing it from being moved back into the operating position. Moving the cover into the protective position involves the needle tube entering the locking area beyond the tab, whereby the tab is elastically deformed and displaced by contact with the needle tube until the needle tube snaps into place behind the tab and is then positioned within the locking area.

[0034] In a particularly advantageous embodiment of the set according to the invention, the base of the tab—viewed in a cross-section of the cover perpendicular to its longitudinal axis—is located, at least when the cover is in its initial position, in a common plane oriented perpendicular to the pivot plane with the needle tube. The tab base here refers to a proximal part of the tab with which the tab is connected to the inner surface of the cover wall. The described embodiment has the advantage that a collision between the tab and the needle tube during the assembly of the protective device on the needle carrier is prevented, since the needle tube and the tab base are at a common "height level" with respect to the pivot plane of the cover.However, since the tab extends at an angle relative to the pivot plane, and the needle tube typically extends centrally through the interior of the cover, the tab necessarily extends past the needle tube in the direction of the pivot plane. A corresponding embodiment is illustrated below using the exemplary embodiment. Examples of implementation

[0035] The invention is explained in more detail below with reference to an exemplary embodiment shown in the figures. These show: Fig. 1: A view of a protective device according to the invention, wherein a cover is in an initial position, Fig. 2: A perspective cross-section through the protective device according to Figure 1 , Fig. 3: A perspective view of part of the protective device according to Figure 1 , Fig. 4: A cross-section through the protective device according to Figure 1 , Fig. 5: A view of the protective device according to Figure 1, with the cover in a usable position, Fig. 6: A perspective view of the protective device according to Figure 5 , Fig. 7: A perspective view of part of the protective device according to Figure 1 , wherein the cover is in a protective position, Fig. 8: A cross-section through the cover of the protective device according to Figure 7 .

[0036] One embodiment, which is described in the Figures 1 to 8 As shown, a protective device according to the invention comprises 1, the one base 3 as well as a cover 4 includes the coverage 4 is relative to the base 3 Designed to be pivotable, with the cover 4 by means of a foil hinge 22 is connected to base 3. The protective device 1 It is a single piece and was manufactured as an injection molded part.

[0037] The base 3 is suitable for use with a needle holder25 to cooperate by means of which a needle tube 2 is worn. In particular, the needle tube 2 into a complementary recess of the needle carrier 25 glued in, so that a longitudinal axis of the elongated needle tube is formed 2 parallel to a longitudinal axis 31 the base 3 extends. This is particularly evident from the following: Figure 1 .

[0038] The protective device 1 is attached as a whole to the needle holder 25 assembled, preferably by automated assembly. The protective device 1 During assembly, it is in an initial state in which the cover 4 is in an initial position. In this initial position, the cover 4 by means of a predetermined breaking point 21 at the base 3 secured so that the cover cannot pivot 4 relative to the base3 is blocked. If the cover is present 4 In their initial position, they have a longitudinal axis 5 the cover 4 and the longitudinal axis 31 the base 3 oriented parallel to each other. In the example shown, the cover 4 furthermore coaxial to the base 3 formed so that the longitudinal axes 5, 31 the cover 4 and the base 3 coincide.

[0039] After the protective device was installed 1 on the needle carrier 25 The needle tube is located 2 inside an interior space 6 the cover 4, the one from a wall 30 the cover 4 is framed. This is particularly evident from the following: Figure 2 . The bearing of the needle tube 2 within the cover 4This has the advantage that a person handling a syringe, on which the needle holder 25 appropriate to avoid injury with or at a needle point 35 of the needle tube 2 is protected. Due to the blockage of the cover's pivoting movement. 4 relative to the base 3 using the predetermined breaking point 21 It is also ensured that an unintentional release of the needle tube 2 is prevented.

[0040] To the needle tube 2 To prepare it for injection use, it is necessary to insert the needle tube. 2 to finally release it. For this purpose, the user can remove the cover from the respective syringe. 4 by applying manual force to a handle tab 33 the cover 4 from the base 3 "break free", whereby the predetermined breaking point 21 is destroyed. This prevents the cover from pivoting. 4using the foil hinge 22 relative to the base 3 released. Accordingly, the cover can be adjusted. 4 now by means of a pivoting in a first pivoting direction within the pivoting plane 8 to be transferred into their operational position, in which the needle tube 2 is released. The cover 4 is within the pivot plane 8 relative to the base 3 pivotable, with one wall 30 the cover 4 in the pivot plane 8 is open on one side, so that the needle tube 2 during the pivoting of the cover 4 without further ado from the interior 6 can leak out. This is particularly evident from the following: Figure 2 . The wall 30 In the example shown, it is U-shaped, with a vertical axis 20 a cross-section of the wall 30parallel to the pivot plane 8 as well as perpendicular to the longitudinal axis 5 the cover 4 is oriented.

[0041] If the cover is in place 4 into their useful position, which is particularly well illustrated by the Figures 5 and 6 The needle tube results 2 Released as explained above, so that it is ready for injection use. In the example shown, the base is 3 with a resting agent 23 equipped, which is set up to provide a rest partner 24 to cooperate, which is involved in the cover 4 is trained. The resting device 23 and the rest partner 24 In this way, they can form a positive connection with each other, thereby securing the cover 4 when present in their useful position at the base 3It can be locked in place. This prevents the needle tube from coming loose during injection use. 2 the cover 4 is moved uncontrollably and thereby disturbs the user of the respective syringe.

[0042] After using the needle tube for injection 2 will the cover 4 Starting from their operating position, in a second pivoting direction opposite to the first pivoting direction, back relative to the base 3 swivelled until the cover 4 assumes its protective position. For the protective position of the cover 4 It is essential that the cover 4 so far back in the second pivoting direction that the needle tube 2 back inside 6 the cover 4 enters and is thereby protected from unintentional contact with a person. Since the needle tube 2Since the syringe may have come into contact with the blood of a person who received an injection of medication, protection against subsequent contact with the needle tube is essential. 2 of essential importance. Accordingly, it is necessary that the coverage 4 the needle tube 2 after being moved into the protective position, it is positioned in such a way that an unintentional release of the needle tube is prevented. 2 which is then impossible.

[0043] To ensure this, the coverage includes 4 a holding device 9, one tab 10, an attack 11 as well as two guide elements 12, 13 includes the holding device 9 is particularly good based on the cross-sections according to the Figures 4 and 8 recognizable. Initially, when the cover is in place. 4 The needle tube is in its initial position 2in an area of ​​the interior 6, the one on this side of the flap 10 and therefore outside a secure area 7 of the interior 6 is formed. In this state, an exit of the needle tube is possible. 2 from the interior 6 not prevented, since the needle tube 2 has not yet been used for injection. According to the above explanation, the covering should be applied accordingly. 4 be suitable to be transferred into a usable position and thereby the needle tube 2 to be released as intended.

[0044] During the pivoting of the cover 4 Starting from the operating position and returning to the protective position, the holding device is used to achieve this. 9 causes the needle tube 2 safe inside 6 the cover 4 is held in place. In the example shown, the cover is used for this purpose. 4pivoted beyond the initial position in the second pivoting direction, so that the longitudinal axes 5, 31 the cover 4 and base 3 together form an angle 32 They enclose each other and are therefore not oriented parallel to each other. The angle 32 In the example shown, the angle is approximately 20°. This type of movement of the cover 4 This causes the needle tube to... 2 not only again on the open side of the wall 30 the cover 4 into the interior 6 enters, but also into the security area 7 beyond the flap 10 dips in. This is done in such a way that the tab 10 upon their first contact with the needle tube 2 is displaced, whereby the tab 10 deformed due to its elastic properties. From a certain position of the cover 4 snaps the needle tube 2 finally behind the flap10 one, which then elastically deforms back into its original shape. This state is particularly well illustrated by... Figure 8 recognizable.

[0045] A movement of the needle tube 2 from the security area 7 It is then no longer possible to get out. This is because the needle tube 2 even in the event of a forced movement of the cover 4 in the first pivoting direction, that is, in the direction of the usable position, against an underside of the tab 10 strikes and moves elastically towards the open side of the wall. 30 deformed. During this deformation, the tab... 10 at least with one of the walls 30 far end 16 against a lower stop surface 34 the attack 11, which causes further deformation of the tab 10 This type of interaction of tabs 10and attack 11 In the example shown, this is achieved by the fact that the tab 10 and the attack 11 starting from opposing inner lateral surfaces 14 the wall 30 the cover 4 extend. The guide elements 12, 13, which runs along the longitudinal axis 5 the cover 4 viewed from both sides of the attack 11 are arranged as well as the attack 11 are assigned, prevent the needle tube 2 after entering the security area 7 into a room below the stop 11 can occur. Therefore, direct contact of the needle tube is not possible. 2 with the stop surface 34 the attack 11 not possible. This prevents the needle tube from 2 from one side of the flap 10 from here to above the end 16 the tab 10move and thereby out of the security area 7 can escape.

[0046] According to the invention, the tab extends 10 related to the pivot plane 8 under a flap angle 15, which in the example shown is 40°. Furthermore, the tab 10 related to the needle tube 2 such a wall 30 arranged that a tab base 26 when the cover is in place 4 in their initial position at least essentially at the same height level as the needle tube 2 This is evident in the fact that the tab base... 26 and the needle tube 2 when the cover is in place 4 in their initial position within a common plane 27 are located perpendicular to the pivot plane 8 is oriented. The described design leads to the following: during the assembly of the protective device1 on a needle holder 25 a collision of the needle tube 2 with the tab 10 is excluded. This is particularly evident from the following: Figure 4 , in which a corresponding distance between the needle tube is clearly evident 2 and the tab 10 is recognizable.

[0047] To the entrance of the needle tube 2 into the security area 7 To further simplify matters, the present embodiment provides that between the end 16 the tab 10, the base of the tab 26 turned away, and an end 17 the attack 11, the tab 10 is facing, perpendicular to the pivot plane 8 measured distance 18 exists. In other words, there is a gap between the tab. 10 and the attack 11 in a direction perpendicular to the pivot plane 8It considers a "gap". The same applies to the direction parallel to the pivot plane. 8, in the area considered between the two ends 16, 17 the tab 10 as well as the attack 11 a distance 19 is present. The one perpendicular to the pivot plane 8 measured distance 18 In the example shown, the distance is approximately 0.15 mm. 19 approximately 0.40 mm. This design has proven particularly useful in reducing the described risk of collision between the tab. 10 and the needle tube 2 to minimize a slight overshoot of the needle tube 2 into the security area 7 to enable and furthermore a secure attachment of the tab 10 against the impact surface 34 the attack 11 to effect. Regarding the entry of the needle tube. 2 into the security area 7It has been shown in particular that a force exerted by the needle tube 2 on the flap 10 must expend in order to deform the latter in such a way that entry into the secured area is prevented 7 The risk of this occurring is particularly low. This has the advantage that the protective device 1 is also suitable for the injection of such agents, which are connected via needle tubes 2 with an extremely small diameter. This applies, for example, to insulin syringes, which use needle tubes with a diameter of less than 0.2 mm.

[0048] In a particularly preferred manner, the protective device shown comprises 1 in addition to the guide elements 12, 13 further guidance elements 28, along the longitudinal axis 5 the cover 4 distributed throughout the interior 6 are arranged. These guide elements 28 extend analogously to the guide elements12, 13 starting from the inner surface of the mantle 14 the wall 30 the cover 4. This is particularly evident from the following: Figure 1 .

[0049] Furthermore, in the example shown, the base has 3 via a safety element 29, which can be seen particularly well based on the Figures 3 and 7 This results in the safety element. 29 serves to cover 4 during their transfer into the protective position, positively locked at the base 2 to lock into place, preventing unintentional swiveling of the cover 4 The cover is prevented from returning to a usable position in the first pivot direction. This would require an intentional application of force to the cover. 4 required to achieve a positive fit with the locking element 29 to resolve. In this case, however, the needle tube would 2cannot be released because it is not possible using the holding device 9 reliable in the security area 7 the interior 6 is held. Experiments have shown that the needle tube 2 in this case, it bends. Reference symbol list

[0050] 1 Protective device 2 Needle tube 3 Base 4 Cover 5 Longitudinal axis 6 Interior 7 Locking area 8 Swivel plane 9 Holding device 10 Tab 11 Stop 12 Guide element 13 Guide element 14 Shell surface 15 Tab angle 16 End 17 End 18 Spacing 19 Spacing 20 Vertical axis 21 Break point 22 Foil hinge 23 Detent 24 Detent partner 25 Needle carrier 26 Tab base 27 Plane 28 Guide element 29 Locking element 30 Wall 31 Longitudinal axis 32 Angle 33 Grip bottle 34 Stop surface 35 Needle tip

Claims

1. A protective device (1) for a needle tube (2) of a syringe, the protective device comprising: - a base (3); and - a cover (4) connected to the base (3), wherein the base (3) is configured to cooperate with a needle carrier (25) by positive form locking wherein the needle carrier (25) supports the needle tube, wherein the cover (4) is configured elongated along a longitudinal axis (5) and defines an interior space (6) in which the needle tube (2) is storable so that a person is protected against an unintentional contact with the needle tube (2), wherein the cover (4) is pivotably supported at the base (3) so that the cover (4) is transferable relative to the base (3) within a pivot plane (8) from a starting position where the needle tube (2) is stored in the interior (6) before being used for injection in a first pivot direction into an operating position where the needle tube (2) is available for injection, and eventually transferrable in a second pivot direction opposite to the first pivot direction into a protective position where the needle tube (2) is stored in the interior space (6) again after being used for injection, wherein the cover (4) is open at one side in the pivot plane (8) so that the needle tube (2) is configured to initially exit from the interior space (6) for injection due to the pivot movement of the cover (4) and configured to enter the interior space (6) again after being used for the injection, wherein the cover (4) includes a retaining device (9) in the interior space (6) wherein the retaining device is configured to interlock the needle tube (2) by positive form locking during transfer of the cover (4) into the protective position so that an unintentional exit of the needle tube (2) from the interior space (6) is prevented after a completed transfer of the cover (4) into the protective position, wherein the retaining device (9) includes a deformable lobe (10), a stop (11) associated with the lobe (10) and at least one guide element (12, 13), wherein the lobe (10) is configured to be deformed by the needle tube (2) during transfer of the cover (4) into its protective position and displaced in a first direction so that the needle tube (2) is able to enter into a safety area (7) arranged behind the lobe (10) in which the needle tube (2) is interlocked behind the lobe (10), wherein the stop (11) is configured at the inner enveloping surface (14) of the cover (4) opposite from the lobe (10) so that the lobe (10) when deformed by the needle tube (2) contacts a contact surface (34) of the stop (11) in a second direction opposite to the first direction so that an unintentional exit of the needle tube (2) from the safety area (7) is prevented, wherein the guide element (12, 13) is associated with the stop (11) and configured to guide the needle tube (2) so that a presence of the needle tube (2) below a stop surface (34) of the stop (11) is prevented after the needle tube (2) enters the safety area (7), characterized in that the lobe (10) extends in undeformed condition from an inner enveloping surface (16) of the cover (4) into the interior space (6) and defines a lobe angle (15) of at least 35° with the pivot plane (8) viewed in a cross section orthogonal to the longitudinal axis (5) of the cover (4).

2. The protective device (1) according to claim 1, characterized in that the lobe angle (15) is at least 37.5°, advantageously at least 40° in the undeformed condition of the lobe (10).

3. The protective device (1) according to one of the preceding claims, characterized in that an offset (18) measured in a direction orthogonal to the pivot plane (8) is provided in a cross section of the cover (4) orthogonal to the longitudinal axis (5) of the cover (4) between an end (16) of the undeformed lobe (10) oriented away from the inner enveloping surface (14) of the cover (4) and an end (17) of the cover (11) oriented towards the lobe (10), wherein the offset (18) is advantageously in a range between 0.05 mm and 0.25 mm, advantageously between 0.10 mm and 0.20 mm.

4. The protective device (1) according to one of the preceding claims, characterized in that an offset (19) is provided in a cross section of the cover (4) orthogonal to the longitudinal axis (5) of the cover (4) between an end (16) of the undeformed lobe (10) oriented away from the inner enveloping surface (14) of the cover (4) and an end (17) of the stop (11) oriented towards the lobe (10) wherein the offset (19) is measured in a direction parallel to the pivot plane (8), wherein the offset (19) is advantageously in a range between 0.20 mm and 0.80 mm, advantageously between 0.25 mm and 0.70 mm, further advantageously between 0.30 mm and 0.60 mm.

5. The protective device (1) according to one of the preceding claims, characterized in that the at least one support element (12, 13) extends from the inner enveloping surface (14) of the cover (4) into the interior space (6).

6. The protective device (1) according to one of the preceding claims, characterized by a plurality of guide elements (12, 13), wherein advantageously at least one guide element (12) is arranged in front of the stop (10) and at least one guide element (13) is arranged behind the stop (10) viewed in the longitudinal direction of the cover (4).

7. The protective device (1) according to one of the preceding claims, characterized in that the cover (4) is configured U-shaped in a cross section orthogonal to its longitudinal axis (5) wherein a vertical axis (20) of the cross section is advantageously oriented parallel to the pivot plane (8) of the cover (4)8. The protective device (1) according to one of the preceding claims, characterized in that the base (3) and the cover (4) are connected with one another by a rated fracture joint (21) when the cover (4) is in its starting position, wherein the rated fracture joint (21) is breakable by a hand force so that the cover (4) is pivotable into its operating position after breaking the rated fracture joint (21).

9. The protective device (1) according to one of the preceding claims, characterized in that the cover (4) and the base (3) are connected with one another by a film hinge (22).

10. The protective device (1) according to one of the preceding claims, characterized in that the cover (4) and the base (3) are arranged coaxial in their starting position, wherein the cover (4) is advantageously pivoted beyond the starting position in the second pivot direction when the cover (4) is in its protective position.

11. The protective device (1) according to one of the preceding claims, characterized by an interlocking device (23) configured at the base (3), wherein the interlocking device is configured to engage an interlocking partner (24) of the cover (4) by positive form locking so that the cover (4) is interlockable in the protective position.

12. A set including the protective device (1) according to one of the preceding claims, and a needle carrier (25) with a needle tube (2) supported therein, wherein the base (3) of the protective device (1) is connected with the needle carrier (25) by positive form locking, so that the needle tube (2) is oriented parallel to the longitudinal axis (5) of the needle tube (2) when the cover (4) is in its starting position.

13. The set according to claim 12, characterized in that a lobe base (26) of the lobe (10) that connects the lobe (10) at the inner enveloping surface (14) of the cover (4) is arranged in a common plane with the needle tube (2) that is perpendicular to the pivot plane (8) when the cover (4) is in its starting position viewed in a cross section of the cover (4) orthogonal to the longitudinal axis (5) of the cover (4).