Protective device for syringe needle tube
The protective device for needle tubes uses a deformable lob and guide elements to securely hold the needle tube within a safety region, addressing issues of unintentional exit and attachment challenges in existing devices.
Patent Information
- Application Number
- JP2024564963
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-05-05
- Filing Date
- 2023-05-03
- Publication Date
- 2025-05-13
- Estimated Expiration
- 2043-05-03
AI Technical Summary
Existing protective devices for needle tubes in syringes may not adequately prevent unintentional exit of the needle tube after use, and can be difficult to attach to needle carriers without risking contact with the needle tip.
A protective device featuring a deformable lob and a stop, along with at least one guide element, that securely holds the needle tube within a safety region by preventing further deformation of the lob once the needle tube enters the region.
The device effectively prevents unintentional release of the needle tube by ensuring it remains within the safety region, even when the device is intentionally mishandled, while also allowing easy attachment to needle carriers without risking needle tip contact.
Smart Images

Figure 2025515106000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to a protection device for a needle tube of a syringe according to the preamble of claim 1. The invention further relates to a set comprising a protection device and a needle carrier with a needle tube supported therein.
[0002] The protection device comprises a base and a cover connected to the base. The cover is pivotable relative to the base, the base and the cover being typically connected to each other by a laminar hinge. The base is configured to cooperate with the needle carrier by positive from locking. The needle carrier is configured to support the needle tube. The needle tube is thus typically centrally glued in a recess of the needle carrier such that a force transmitting connection is provided between the needle tube and the needle carrier. The base is typically secured in the needle carrier by a form-locking connection with the needle carrier.
[0003] The cover is elongated and extends along a longitudinal axis. The cover defines an interior space capable of supporting the needle tube such that a person is protected against unintentional contact with the needle tube. In particular, a person should be protected against unintentional contact with a tip of the needle tube, especially after the needle tube has been used for an injection. In this way, the transmission of infectious diseases from a patient who has been injected with the needle tube to a person who treats the patient can be prevented.
[0004] The pivoting ability of the cover relative to the base is provided such that the cover is movable in a pivot plane relative to the base. In doing so, the cover can be moved in a first pivoting direction relative to the base from a starting position, in which the needle is supported inside the cover before being used for an injection, to an actuated position, in which the needle is available for injection, i.e. the needle is no longer inside the cover. After being used for an injection, the cover can be moved in a second pivoting direction opposite to the first pivoting direction from the actuated position to a protected position, in which the needle is again supported inside after being used for an injection, and the needle is then protected against unintentional contact with a person as described above.
[0005] The cover is open on one side in the pivot plane so that the needle can exit the cover when the cover is transferred from the starting position to the working position, and finally so that the needle can re-enter the cover when the cover returns from the working position to the protective position. In particular, the cover wall surrounding the interior of the cover may only surround the interior on three sides, while the fourth side is open.
[0006] The cover includes a retaining device inside the cover, the retaining device being configured to interlock the needle tube by a mating lock when the needle tube is transferred to the protective position, such that the needle tube is prevented from unintentionally exiting from the interior space after the cover is transferred to the protective position, in other words, the retaining device is used to hold the needle tube so that it is not released by re-pivoting the cover relative to the base after using the needle tube for an injection. [Background technology]
[0007] A typical protective device is already known from WO2021 / 008717A1. This document describes a protective device including a cover including a retaining device configured to securely retain a needle tube. The retaining device includes two lobes, each starting from an inner enveloping surface of the wall of the cover and extending towards each other. The lobes are thus inclined with respect to the pivot plane and are elastic so that the needle tube can deform and displace the lobes and can be interlocked behind the lobes. It is thus ensured that when the cover is pivoted relative to the base of the protective device, the needle tube cannot leave the safety area defined behind the lobes, and unintentional injury to a person by the needle tube is prevented.
[0008] Although the safety of known protection devices against unintentional exit of the needle tube from the safe area is already considerable, intentional misoperation of the safety device is still possible and can cause the needle tube to exit the safe area after having been used for an injection, resulting in a subsequent risk of infection.
[0009] US Patent No. 5,490,841 B1 discloses another protective device with a cover. The cover includes a retaining device including a lobe oriented at an oblique angle inside the cover. The cover securely confines the needle tube after use within a safety area inside the cover, the lobe being configured to be flexible so as to be initially elastically deformable to allow the needle tube to enter the safety area. Deformation in the opposite direction, which would lead to the needle tube leaving the safety area, is prevented by a stop configured on the inner enveloping surface of the wall of the cover at a location opposite the lobe.
[0010] This configuration is disadvantageous because the lobes extend inside the cover such that they may strike the needle tube before it is used for injection, which is particularly disadvantageous with regard to automated production of syringes configured with a needle carrier including a needle tube and a protective device, since the protective device cannot be easily mounted at the base on or at the needle carrier without causing the needle tube supported by the needle carrier to strike the lobes located inside the cover. [Prior art documents] [Patent documents]
[0011] [Patent Document 1] WO2021 / 008717A1 [Patent Document 2] U.S. Patent No. 5,490,841(B1) Summary of the Invention [Problem to be solved by the invention]
[0012] It is therefore an object of the present invention to provide a protection device which is applicable to needle carriers in a particularly simple manner and which also provides a high degree of safety against the unintentional exit of the needle tube from the cover after it has been used for an injection. [Means for solving the problem]
[0013] The object is achieved by a protection device having the features of claim 1. Advantageous embodiments can be derived from the dependent claims.
[0014] The protection device according to the invention is characterized in that the retaining device comprises a deformable lobe, a stop associated with the lobe and at least one guide element. The lobe is configured to be deformed by the needle tube such that the lobe is displaced in a first direction so that the needle tube can enter an internal safety area located behind the lobe when the cover is moved to the protective position. The needle tube is then interlocked behind the lobe such that the lobe holds the needle tube in the safety area and prevents unintentional release of the needle tube. The stop is formed on the inner surrounding surface or wall of the cover opposite the lobe and is configured to contact a lower contact surface of the stop when the lobe is deformed by the needle tube in a second direction directed opposite to the first direction so that further deformation of the lobe is prevented.
[0015] This prevents the needle tube from unintentionally exiting the safety zone. In an undeformed state, the lobe extends from the inner surrounding surface of the cover into the interior of the cover, and in an advantageous embodiment the lobe forms a lobe angle with the pivot plane in a cross section extending perpendicular to the longitudinal axis of the cover of at least 35°. Advantageously, this angle is at least 40°, and even more advantageously, it is 45°.
[0016] At least one guide element is associated with the stop and is configured to guide the needle tube arranged in the safety area in such a way that the needle tube is prevented from being below a contact surface of the stop after the needle tube has entered the safety area. In particular, the guide element can close off the space below the stop such that the needle tube cannot contact the guide element laterally and move into the space below the stop. Thus, the needle tube can be prevented from moving below the stop and between the lobe and the stop after entering the safety area so as to leave the safety area again.
[0017] The safety device according to the invention has many advantages. In particular, the protection device ensures that the needle is kept safe in the cover after it has been used for injection and the cover has been pivoted to the protection position. This is because after the needle has entered the safety area, it cannot leave the safety area anymore, since entering the safety area requires a temporary displacement of the elastic lobe. A movement of the needle in the direction of leaving the safety area necessarily brings the needle into contact with the lobe from below, which again elastically deforms the lobe, but due to the adapted contour of the lobe and the stop, this deformation brings the lobe into contact with the contact surface of the stop, preventing further deformation of the lobe. The at least one guide element ensures that the needle comes into contact with the underside of the lobe and cannot come into contact with the stop side of the stop, in particular directly from the side of the lobe. Experiments have shown that even when the protection device is deliberately tampered with, it is not possible to remove the needle from the safety area after entering the safety area.
[0018] And another advantage of the invention is that the protection device can be easily attached to the needle carrier configured with the needle tube. Thus, the needle tube is prevented from hitting the lobe of the cover when the cover is in the starting position. This is achieved by a steeper inclination of the lobe with respect to the pivot plane, which according to the above description is at least 35°. Known covers are inclined at a rather shallow angle with respect to the pivot plane and extend substantially centrally through the interior of the cover. However, hitting of the needle tube with this shallower lobe is most likely during installation of the cover, since the needle tube fills this area when the cover is in the starting position.
[0019] Another advantage of the configuration according to the invention is that the safety against the needle tube leaving the safety area is provided by the cooperation of the soft lobe and the hard stop. This facilitates that the lobe itself can be constructed relatively soft, i.e. less rigid, since it does not fix the needle tube by itself. The slight deformability of the lobe therefore does not reduce the safety, since the lobe can be easily deformed when the needle tube contacts the underside of the lobe, but the movement of the lobe in the opposite direction is prevented by the contact of the lobe at the contact surface of the stop. However, the deformability of the lobe has the specific advantage that the protection device can also be used when thin needle tubes are used. In particular, needle tubes used, for example, for insulin syringes, have a particularly small diameter, which makes the needle tube particularly easily deformable. If, as in the prior art, the lobe is constructed rigidly to fix the needle tube in the safety area, the needle tube may not be able to displace the lobe, but the lobe will deform the needle tube. This would prevent the needle from reliably entering the safety area, making the syringe with this protection device unsafe. This lack of safety is not caused by the needle being able to unintentionally leave the safety area, but by the inability of the needle to reliably enter the safety area. A soft lobe eliminates this risk.
[0020] In an advantageous embodiment of the protection device according to the invention, a cross section of the cover perpendicular to the longitudinal axis of the cover exhibits an offset, measured perpendicular to the pivot plane, between the end of the undeformed lobe directed away from the inner envelope surface of the cover and the end of the stop directed towards the cover. In other words, an offset, measured perpendicular to the pivot plane, is provided in this embodiment between the ends of the stop and the lobe directed towards each other. This offset is advantageously in the range between 0.05 mm and 0.25 mm, more advantageously between 0.1 mm and 0.2 mm. Thus, in this embodiment, the undeformed lobe does not reach below the contact surface of the stop. On the contrary, a minimal gap is provided between the lobe and the stop, facilitating the entry of the needle tube into the safety area inside the cover. In particular, only a small deformation of the lobe is required in order for the needle tube to enter the safety area and fit behind the lobe. This configuration is therefore particularly advantageous for facilitating the entry of the needle tube into the safety area with the effect of a small force on the needle tube, and entry of the needle tube can be effected particularly reliably, and unintentional deformation of the needle tube is prevented.
[0021] Additionally, an embodiment of the protection device is particularly advantageous in which the cross section of the cover perpendicular to the longitudinal axis of the cover exhibits an offset, measured in a direction parallel to the pivot plane, between the end of the undeformed lobe directed away from the inner surrounding surface of the cover and the end of the stop directed towards the lobe. The offset is preferably in the range between 0.20 mm and 0.80 mm, more preferably between 0.20 mm and 0.70 mm, more preferably between 0.30 mm and 0.60 mm. This embodiment also has the advantage that the entry of the needle tube into the safety area is simplified, since the lobe only needs to be displaced a minimal amount in order for the needle tube to fit and lock behind the lobe. In principle, the needle tube can pass through the groove between the lobe and the stop formed by the above-mentioned offset and thus leave the safety area. However, this is prevented by the guide element guiding the needle tube, which cannot move under the stop and access the provided groove. Thus, movement of the needle tube in a direction out of the safety zone will bring the needle tube into contact with the underside of the lobe, causing the deformation of the lobe described above, until the lobe contacts the contact surface of the stop.
[0022] Advantageously, the at least one guide element extends inwardly from the inner surrounding surface of the cover, advantageously in such a way that the space below the contact surface of the cover is completely sealed off with respect to the needle tube, the associated advantages being explained above.
[0023] It is particularly advantageous for the protective device to include a plurality of guide elements, at least one of which is arranged in front of the stop and at least one of which is arranged behind the stop, as viewed in the longitudinal direction of the cover. This arrangement has the advantage that when the needle tube is deformed, in particular when it is bent along its longitudinal axis, the movement of the needle tube into the space below the contact surface of the cover is reliably prevented. Thus, the space below the contact surface of the cover is blocked from both sides of the cover by the two guide elements, and the needle tube cannot reach this space and is reliably held below the lobe.
[0024] In another embodiment of the protection device according to the invention, the cover has U-shaped walls in a cross section perpendicular to the longitudinal axis of the cover, the walls defining an interior space. The cover is therefore advantageously configured such that the vertical axis of the cross section of the cover is oriented parallel to the pivot axis of the cover. In particular, the cross section of the cover can be at least substantially parallel at the opposing inner envelope faces from which the lobe extends on one side and the stop extends on the other side. Corresponding configurations can be derived from the following embodiments. This configuration is particularly advantageous for ensuring the cooperation of the lobe and the stop.
[0025] Advantageously, the protection device is configured such that the base and the cover are force-transmittingly connected to one another in the starting position by a nominal break joint ("initial closure"). The nominal break joint can be broken by applying a manual force, after which the cover can be pivoted into the working position. This embodiment is particularly advantageous for a reliable support of the needle in the cover before it is used for injection, the nominal break joint preventing an unintentional pivoting of the cover into the working position and an unintentional release of the needle. Furthermore, it is not necessary to use a separate cover, for example in the form of a closing cap, which is to be placed on the needle for protection before it is used for injection. On the contrary, the function of protecting the needle before it is used for injection and also after it has been used for injection can be performed by the cover itself. This is particularly easy, since the above-mentioned configuration of the lobes inclined at a steep angle to the pivot plane eliminates the above-mentioned risk of the needle hitting the lobes during assembly of the protection device on the needle carrier. When the rated break joint is broken, it is an indication that the needle tube may already be in use, so that the user of the protective device does not yet use the needle tube when he has not opened the protective device himself, i.e., he has not broken the rated break joint.
[0026] In another advantageous embodiment of the protection device according to the invention, the cover and the base are connected to one another by a lamellar hinge, which is particularly well suited for establishing the pivoting ability of the cover relative to the base while at the same time providing a one-piece, integral construction of the protection device, and is therefore particularly advantageous when the protection device is provided in one piece.
[0027] Furthermore, a configuration of the protection device can be advantageously advantageous in which the cover and the base are arranged coaxially relative to one another when the cover is in the starting position. In this embodiment, the longitudinal axes of the base and the cover are oriented parallel to one another. Advantageously, the longitudinal axes of the cover and the base coincide.
[0028] Alternatively or additionally, it may be particularly advantageous for the cover to be pivoted in the second pivoting direction when the cover is in the protective position such that the longitudinal axes of the base and the cover are not oriented parallel to each other, but form an angle greater than 0° with respect to each other. This configuration has the advantage that the needle tube can be brought into contact with the lobe in a particularly simple manner, displacing the lobe as described above, so that the needle tube finally enters the internal safety area of the cover. In the embodiment in which the cover is inclined at different angles relative to the base between the start position and the protective position, it is particularly simple to prevent the needle tube from hitting the cover when mounting the protection device on the needle carrier, whereas hitting the needle tube with the cover is deliberately caused when transferring the cover to the protective position in order to allow the needle tube to enter the safety area. Furthermore, the described embodiment is advantageous in that the cover can be attached at the base in a particularly simple manner, advantageously by using a mating lock, to fix the cover in the protective position.
[0029] It can therefore be particularly advantageous for at least one interlocking device to be configured on the base, which cooperates with at least one interlocking counterpart of the cover by mating locking, such that the cover is interlockable into the protective position. The cooperation of the interlocking device with its interlocking counterpart can be implemented in a particularly simple manner by pivoting the cover relative to the base beyond a starting position, such that, when transferring the cover into the protective position, the interlocking counterpart of the cover is brought into contact with the interlocking device of the base. Engagement of the interlocking counterpart with the interlocking device ensures that the cover is not unintentionally moved back from the protective position into the operating position.
[0030] The object is also achieved by the set of features of claim 12. Advantageous embodiments can be derived from the associated dependent claims.
[0031] The set includes a protection device according to the invention as described above and a needle carrier with a needle tube supported therein. The base of the protection device is connected to the needle carrier by a mating lock such that when the cover is in the starting position, the needle tube is oriented parallel to the longitudinal axis of the cover. When the cover is pivoted in a first pivot direction from the starting position to the working position in the pivot plane, the needle tube is released for injection use. The cover can then be pivoted in a second pivot direction opposite to the first pivot direction, in a direction towards the starting position, so that the needle tube again enters the interior of the cover and is protected against unintended human contact. As described above, it is particularly advantageous that when the cover reaches the protection position, the cover is locked to the base so that it is prevented from moving the cover to the working position again. When the cover is moved to the protection position, the needle tube passes over the lobe and enters the safety area, where the lobe is elastically deformed by contact with the needle tube and displaced until the needle tube fits into a fixed position behind the lobe and is thereafter placed in the safety area.
[0032] In a particularly advantageous embodiment of the set according to the invention, the lobe base of the lobe is arranged in a common plane with the needle tube perpendicular to the pivot plane, at least when the cover is in the starting position, as seen in a section of the cover perpendicular to the longitudinal axis of the cover. The lobe base therefore refers to the proximal part of the lobe, by which the lobe is connected to the inner surrounding surface of the wall of the cover. The described embodiment has the advantage that the lobe is prevented from hitting the needle tube during the installation of the protection device in the needle carrier, since the needle tube and the lobe base are at the same height level with respect to the pivot plane of the cover. Since the lobe extends at an angle to the pivot plane and the needle tube typically extends through the center of the interior space of the cover, the lobe consequently extends beyond the needle tube in a direction towards the pivot plane. This embodiment is described below.
[0033] The invention will now be described by way of example only with reference to the accompanying drawings, in which: [Brief description of the drawings]
[0034] [Figure 1] FIG. 2 shows a view of the protection device according to the invention with the cover in the starting position. [Diagram 2] 1 is a perspective cross-sectional view of a protection device according to claim 1; [Diagram 3] FIG. 2 is a perspective view of a part of the protection device according to FIG. [Figure 4] 2 is a cross-sectional view of the protection device according to FIG. 1; [Diagram 5] FIG. 2 is a view of the protective device according to FIG. 1 with the cover in the operative position. [Figure 6] FIG. 6 is a perspective view of the protection device according to FIG. 5; [Figure 7] FIG. 2 is a perspective view of a part of the protection device according to FIG. 1, the cover being in a protective position. [Figure 8] FIG. 8 shows a cross section through the cover of the protection device according to FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0035] The embodiment illustrated in Figures 1 to 8 includes a protection device 1, which includes a base 3 and a cover 4. The cover 4 is configured to be pivotable relative to the base 3, the cover 4 being connected to the base 3 by a lamellar hinge 22. The protection device 1 is integrally constructed in one piece and is produced as an injection molded part.
[0036] The base 3 is configured to cooperate with a needle carrier 25 which supports the needle tube 2. The needle tube 2 is in particular bonded in a complementary recess of the needle carrier 25 such that the longitudinal axis of the elongated needle tube 2 extends parallel to the longitudinal axis 31 of the base 3. This is particularly clear from FIG.
[0037] The protection device 1 is mounted entirely on the needle carrier 25, which is advantageously done automatically. During assembly, the protection device 1 is in a starting position and the cover 4 is in a starting position. In this starting position, the cover 4 is attached to the base 3 by a nominal break joint 21 such that pivoting of the cover 4 relative to the base 3 is prevented. When the cover 4 is in the starting position, the longitudinal axis 5 of the cover 4 and the longitudinal axis 31 of the base 3 are oriented parallel to each other. In the illustrated embodiment, the cover 4 is configured coaxially with the base 3, so that the longitudinal axes 5, 31 of the cover 4 and the base 3 are coincident.
[0038] After mounting the protection device 1 on the needle carrier 25, the needle tube 2 is located in an internal space 6 of the cover 4, which is surrounded by a wall 30 of the cover 4. This is particularly clear from FIG. 2. Supporting the needle tube 2 in the cover 4 has the advantage that a person operating a syringe including the needle carrier 25 is protected against trauma by a needle tip 35 of the needle tube 2. The prevention of pivotal movement of the cover 4 relative to the base 3 by the nominal break joint 21 prevents unintentional release of the needle tube 2.
[0039] In order to make the needle tube 2 usable for injection, it is necessary to release the needle tube 2. The syringe user can therefore break the cover 4 from the base 3 by applying a manual force at the gripping lobes 33 of the cover 4 such that the nominal break joint 21 is broken. This releases the pivoting ability of the cover 4 relative to the base 3 using the lamellar hinge 22. The cover 4 can therefore be moved to the working position by pivoting the cover 4 in a first pivoting direction in the pivoting plane 8, and the needle tube 2 is released to the working position. The cover 4 is therefore pivotable relative to the base 3 in the pivoting plane 8, and the wall 30 of the cover 4 is open on one side in the pivoting plane 8 so that the needle tube 2 can easily exit the interior space 6 during pivoting of the cover 4. This is clearly evident from FIG. 2. In the illustrated embodiment, the wall 30 is configured in a U-shape, the vertical axis 20 of the cross section of the wall 30 being oriented parallel to the pivot axis 8 and perpendicular to the longitudinal axis 5 of the cover 4 .
[0040] As is clearly evident from Figures 5 and 6, when the cover 4 is in the operative position, the needle tube 2 has been released according to the above description, and the needle tube 2 is ready to be used for injection. In the illustrated embodiment, the base 3 is provided with an interlocking device 23 configured to cooperate with an interlocking counterpart 24 configured on the cover 4. And, the interlocking device 23 and the interlocking counterpart 24 can be matingly interlocked with each other, such that the cover 4 can be interlocked with the base when the cover 4 is in the operative position. In this way, uncontrolled use of the cover 4, which would cause discomfort to the user of the syringe, is prevented when the needle tube 2 is used for injection.
[0041] After the needle 2 has been used for injection, the cover 4 is pivoted back from the working position towards the base 3 in a second pivoting direction opposite to the first pivoting direction until the cover 4 assumes the protective position. For the protective position of the cover 4, it is important that the cover 4 is pivoted back far enough in the second pivoting direction so that the needle 2 again enters the interior space 6 of the cover 4 and is protected against unintentional human contact. Protection against subsequent contact with the needle 2 is important, since the needle 2 may be in contact with the blood of a person who has been injected with a drug by the syringe. It is therefore necessary for the cover 4 to receive the needle 2 after it has been moved to the protective position, so that unintentional release of the needle 2 is subsequently made impossible.
[0042] To facilitate this, the cover 4 comprises a retaining device 9, which comprises a lobe 10, a stop 11 and two guide elements 12, 13. The retaining device 9 is particularly visible in the cross-section according to Fig. 4 and Fig. 8. When the cover 4 is in the starting position, the needle 2 is located in a part of the interior space 6 formed proximally of the lobe 10 and is therefore located outside the safety area 7 of the interior space 6. In this state, the needle 2 has not yet been used for injection and is not prevented from leaving the interior space 6. In accordance with the previous explanation, the cover 4 is configured to be moved to an activated position in which the needle 2 is released for use.
[0043] During the pivoting of the cover 4 from the working position back to the protective position, the retaining device 9 holds the needle tube 2 securely in the internal space 6 of the cover 4. Then, in the illustrated embodiment, the cover 4 is pivoted beyond the starting position in the second pivoting direction, so that the longitudinal axes 5, 31 of the cover 4 and the base 3 are at an angle 32 to each other and are therefore not oriented parallel to each other. Then, in the illustrated embodiment, the angle 32 is about 20°. This movement of the cover 4 not only causes the needle tube 2 to enter the internal space 6 again at the open side of the wall 30 of the cover 4, but also into the safety area 7 distal to the lobe 10. This is caused by displacing the lobe 10 on the first contact with the needle tube 2, which is deformed due to its elastic nature. Starting from a given position of the cover 4, the needle tube 2 fits into place behind the lobe 10, which is then deformed back to its original shape. This state is clear from FIG. 8.
[0044] Thus, the movement of the needle tube 2 out of the safety area 7 is no longer possible. This is caused by the fact that even in the forced movement of the cover 4 in the first pivoting direction, i.e. towards the working position, the needle tube 2 itself comes into contact with the underside of the lobe 10 and elastically deforms it in the direction towards the open side of the wall 30. During this deformation, the lobe 10 comes into contact with the lower contact surface 34 of the stop 11 at least at the end 16 of the lobe 10 that is directed away from the wall 30, and further deformation of the lobe 10 is prevented. In the illustrated embodiment, this kind of cooperation between the lobe 10 and the stop 11 is implemented in that the lobe 10 and the stop 11 extend from the facing inner surrounding surface 14 of the wall 30 of the cover 4. Guide elements 12, 13 arranged on either side of the stop 11 along the longitudinal axis 5 of the cover 4 and associated with the stop 11 prevent that the needle tube 2 can move into the space below the stop 11 after entering the safety area 7. Therefore, direct contact of the needle tube 2 with the contact surface 34 of the stop 11 is not possible, which prevents the needle tube 2 from moving from one side of the lobe 10 into the area above the end 16 of the lobe 10 and potentially escaping from the safety area 7.
[0045] According to the invention, the lobes 10 extend with a lobe angle 15, which in the illustrated embodiment is 40°, with respect to the pivot plane 8. Furthermore, the lobes 10 are arranged with respect to the needle tube 2 of the wall 30 such that the lobe base 26 is at substantially the same height level as the needle tube 2 when the cover 4 is in the starting position. Thus, when the cover 4 is in the starting position, the lobe base 26 and the needle tube 2 lie in a common plane 27 perpendicular to the pivot plane 8. This configuration helps to prevent the needle tube 2 from hitting the lobes 10 when the protection device 1 is mounted in the needle carrier 25. This is clearly evident from FIG. 4, which clearly shows the corresponding offset between the needle tube 2 and the lobes 10.
[0046] To further simplify the entry of the needle tube 2 into the safety zone 7, in this embodiment it is provided that an offset 18 is provided between the end 16 of the lobe 10 directed towards the lobe base 26 and the end 17 of the stop 11 directed towards the lobe 10, measured perpendicular to the pivot plane 8. In other words, a gap is provided between the lobe 10 and the stop 11, viewed in a direction perpendicular to the pivot plane 8. The same applies with respect to a direction parallel to the pivot plane 8, where an offset 19 is provided between the two ends 16, 17 of the lobe 10 and the stop 11. In the illustrated embodiment, the offset 18, measured perpendicular to the pivot plane 8, is 0.15 mm and the offset 19 is approximately 0.40 mm. This embodiment has proven to be particularly useful for minimizing the risk of impact between the lobe 10 and the needle tube 2, facilitating an easy transfer of the needle tube 2 into the safety zone 7, and also for causing a reliable stop of the lobe 10 at the contact surface 34 of the stop 11. It has become clear that, with regard to the needle 2 entering the safety zone 7, the application of a force by the needle 2 to the lobe 10 is particularly small in order to deform the lobe 10 so that the needle 2 can enter the safety zone 7. This has the advantage that the protection device 1 is also suitable for injecting substances which are injected with needles 2 having a particularly small diameter. This applies in particular to insulin injections, where needles 2 having a diameter smaller than 0.2 mm are used.
[0047] Particularly advantageously, the protective device 1 comprises, in addition to the guide elements 12, 13, further guide elements 28, which are arranged in the interior space 6 distributed along the longitudinal axis 5 of the cover 4. These guide elements 28 extend from the inner surrounding surface 14 of the wall 30 of the cover 4 in the same way as the guide elements 12, 13. This is clearly evident from FIG.
[0048] Furthermore, in the illustrated embodiment, the base 3 includes a safety element 29, as is clear from figures 3 and 7. The safety element 29 locks the cover 4 on the base 3 by a snap-lock, such that when the cover 4 is moved to the protective position, an unintentional pivoting in a first pivoting direction of the cover 4 back to the working position is prevented. This requires deliberate application of force to the cover 4 in order to disengage the form-lock with the safety element 29. Even in this case, the needle tube 2 is not released, since it is securely held in the safety area 7 of the interior space 6 by the holding device 9. Tests have shown that in this case the needle tube 2 is bent and deformed. [Explanation of symbols]
[0049] 1 Protective device 2 needle tube 3 base 4 Cover 5 Longitudinal axis 6. Interior Space 7 Safety area 8 Pivotal plane 9 Holding device 10. Rob 11 Stops 12 Guide Elements 13 Guide Elements 14 Siege Surface 15 Lob Angle 16 End 17 End 18 Offset 19 Offset 20 vertical axis 21 Rated breaking joint 22 Thin plate hinge 23 Interlocking device 24 Interlocking Partners 25 needle carrier 26 Base of the Lob 27 plane 28 Guide Elements 29 Safety factors 30 Wall 31 Longitudinal axis 32 angles 33 Grasping Rob 34 Contact surface 35 Needle tip
Claims
1. A protection device (1) for a needle tube (2) of a syringe, comprising: The protection device comprises: A base (3); A cover (4) connected to the base (3); Equipped with the base (3) is adapted to cooperate with a needle carrier (25) by a snap-fit engagement, the needle carrier (25) supporting the needle tube; the cover (4) is elongated along a longitudinal axis (5) and defines an internal space (6) capable of accommodating the needle tube (2) so that a person is protected against unintentional contact with the needle tube (2); the cover (4) is pivotally supported on the base (3) such that the cover (4) can be moved in a pivot plane (8) relative to the base (3) in a first pivot direction from a starting position in which the needle (2) is housed in the internal space (6) before being used for an injection to an operating position in which the needle (2) is available for an injection, and finally in a second pivot direction opposite to the first pivot direction to a protected position in which the needle (2) is again housed in the internal space (6) after being used for an injection, the cover (4) is open on one side in the pivot plane (8) so that the needle tube (2) is initially adapted to leave the interior space (6) for an injection by the pivot movement of the cover (4) and is adapted to re-enter the interior space (6) after it has been used for the injection, The cover (4) includes a retaining device (9) in the internal space (6), the retaining device being configured to interlock the needle tube (2) by a snap-lock during the transition of the cover (4) to the protective position, such that the needle tube (2) is prevented from unintentionally exiting from the internal space (6) after the transition of the cover (4) to the protective position is completed. In the protection device (1), said holding device (9) comprising a deformable lobe (10), a stop (11) associated with said lobe (10) and at least one guide element (12, 13), the lobe (10) is configured to be deformed by the needle tube (2) during the transition of the cover (4) to a protective position and to be displaced in a first direction so that the needle tube (2) can enter a safety area (7) arranged behind the lobe (10), the needle tube (2) being interlocked behind the lobe (10); the stop (11) is configured on an inner surrounding surface (14) of the cover (4) opposite the lobe (10) such that the lobe (10) contacts a contact surface (34) of the stop (11) in a second direction opposite to the first direction when the lobe (10) is deformed by the needle tube (2) so as to prevent the needle tube (2) from unintentionally exiting the safety area (7); the guide elements (12, 13) are associated with the stop (11) and are configured to guide the needle tube (2) in such a way that the needle tube (2) is prevented from being below a contact surface (34) of the stop (11) after the needle tube (2) has entered the safety area (7); Protective device (1).
2. 2. A protection device (1) according to claim 1, characterized in that the lobes (10) extend in an undeformed state from an inner surrounding surface (14) of the cover (4) into the interior space (6) and, viewed in a cross section perpendicular to the longitudinal axis (5) of the cover (4), define a lobe angle (15) of at least 35°, advantageously at least 37.5°, more advantageously at least 40° with the pivot plane (8).
3. 3. A protection device (1) according to claim 1 or 2, characterized in that an offset (18), measured in a direction perpendicular to the pivot plane (8), is provided between an end (16) of the undeformed lobe (10) directed away from the inner surrounding surface (14) of the cover (4) and an end (17) of the stop (11) directed towards the lobe (10), in a cross-section of the cover (4) perpendicular to the longitudinal axis (5) of the cover (4), said offset (18) being preferably within a range between 0.05 mm and 0.25 mm, preferably between 0.10 mm and 0.20 mm.
4. 4. The protective device (1) according to claim 1, characterized in that an offset (19) is provided, in a cross section of the cover (4) perpendicular to the longitudinal axis (5) of the cover (4), between an end (16) of the undeformed lobe (10) directed away from the inner surrounding surface (14) of the cover (4) and an end (17) of the stop (11) directed towards the lobe (10), the offset (19) being measured in a direction parallel to the pivot plane (8), the offset (19) being preferably within a range between 0.20 mm and 0.80 mm, preferably between 0.25 mm and 0.70 mm, and more preferably between 0.30 mm and 0.60 mm.
5. 5. The protection device (1) according to claim 1, characterized in that the at least one guide element (12, 13) extends from the inner surrounding surface (14) of the cover (4) into the interior space (6).
6. The protective device (1) according to any one of claims 1 to 5, characterized by a plurality of guide elements (12, 13), preferably at least one guide element (12) being arranged in front of the stop (11) as viewed in the longitudinal direction of the cover (4) and at least one guide element (13) being arranged behind the stop (11).
7. 7. The protective device (1) according to claim 1, characterized in that the cover (4) is configured U-shaped in a cross section perpendicular to the longitudinal axis (5) of the cover (4), the vertical axis (20) of the cross section being preferably oriented parallel to the pivot plane (8) of the cover (4).
8. 8. The protective device (1) according to any one of claims 1 to 7, characterized in that the base (3) and the cover (4) are connected to each other by a rated break joint (21) when the cover (4) is in a starting position, the rated break joint (21) being breakable by manual force such that the cover (4) can be pivoted to an operating position after breaking the rated break joint (21).
9. Protection device (1) according to any one of the preceding claims, characterised in that the cover (4) and the base (3) are connected to each other by a laminar hinge (22).
10. 10. The protective device (1) according to any one of claims 1 to 9, characterized in that the cover (4) and the base (3) are arranged coaxially in a starting position, and when the cover (4) is in the protective position, the cover (4) is pivoted beyond the starting position, preferably in the second pivot direction.
11. The protective device (1) according to any one of claims 1 to 10, characterized by an interlocking device (23) configured on the base (3), the interlocking device being configured to engage with an interlocking counterpart (24) of the cover (4) by a mating lock so that the cover (4) can be interlocked in the protective position.
12. A set comprising a protection device (1) according to any one of claims 1 to 11 and a needle carrier (25) including the needle tube (2) supported therein, the base (3) of the protection device (1) is connected to the needle carrier (25) by a snap-fit lock such that the needle tube (2) is oriented parallel to the longitudinal axis (5) of the needle tube (2) when the cover (4) is in a starting position; set.
13. 13. The set according to claim 12, characterized in that the lobe bases (26) of the lobes (10) connecting the lobes (10) on the inner surrounding surface (14) of the cover (4) are arranged in a common plane with the needle tube (2) perpendicular to the pivot plane (8) when the cover (4) is in the starting position, as seen in a section of the cover (4) perpendicular to the longitudinal axis (5) of the cover (4).
Citation Information
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