Protective device for syringe needle
By using a combination of deformable projections, stops and guide elements in the needle protection device, the problem of accidental departure and installation collision of the needle tube after injection is solved, and the effect of high safety holding and easy installation of the needle tube is achieved.
Patent Information
- Application Number
- CN202380044936.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-05-05
- Filing Date
- 2023-05-03
- Publication Date
- 2025-01-14
AI Technical Summary
The existing syringe protection device is prone to accidental operation to leave the syringe from the safe area after injection, which increases the risk of infection. At the same time, in the automated production of syringe, there is a risk of collision between the syringe and the protective device installation.
A holding device with deformable projections, stops and guide elements is adopted. When transferred to the protective position, the projections are interlocked by the needle tube to deform. The stopper prevents the projections from further deforming, and the guide element blocks the needle tube side. Move to ensure that the needle is in a safe area.
Effectively prevent the needle tube from being accidentally released after injection, improve safety, and avoid collision between the needle tube and the protrusion during installation. It is suitable for thin needle tubes to ensure that the needle tube can enter the safe area reliably.
Smart Images

Figure CN119317464A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to a protective device for a needle barrel of a syringe according to the preamble of claim 1. The invention also relates to a kit comprising the protective device and a needle carrier in which the needle barrel is supported.
[0002] The protective device comprises a base and a cover connected to the base. The cover can be pivoted relative to the base, wherein the base and the cover are usually connected to each other by a film hinge. The base is configured to cooperate with the needle carrier by a positive shape lock. The needle carrier is configured to support the needle tube. Therefore, the needle tube is usually glued centrally into a recess in the needle carrier, thereby providing a force-transmitting connection between the needle tube and the needle carrier. Due to the shape-locking connection of the base to the needle carrier, the base is usually fixed at the needle carrier.
[0003] The cover is elongated and extends along the longitudinal axis. The cover defines an interior space that can support the needle tube, thereby preventing a person from accidentally contacting the needle tube. In particular, a person should be protected from accidental contact with the needle tip of the needle tube, especially after the needle tube has been used for an injection. In this way, the transfer of infectious diseases from a patient injected with the needle tube to a person treating the patient can be prevented.
[0004] The cover is provided to be pivotable relative to the base, so that the cover is movable relative to the base in a pivot plane. In this way, the cover can be transferred in a first pivot direction relative to the base from a starting position into an operating position, in which the needle tube is supported in the interior of the cover before being used for injection. In the operating position, the needle tube can be used for injection, which means that the needle tube is no longer located in the interior of the cover. After being used for injection, the cover can be transferred in a second pivot direction opposite to the first pivot direction from the operating position into a protective position, in which the needle tube is supported in the interior again after being used for injection. Thus, the needle tube is protected from accidental contact with a person in the above-mentioned way.
[0005] In order to enable the needle tube to leave the cover when the cover transitions from the starting position into the operating position and finally reenter the cover when the cover returns from the operating position into the protective position, one side of the cover is open in the pivot plane. In particular, the wall of the cover enclosing the interior of the cover can enclose the interior only on three sides and be open on the fourth side.
[0006] The cover comprises a retaining device in the interior of the cover, which is configured to interlock the needle tube by forced shape locking when the needle tube is transferred into the protection position. The interlocking is performed so that the needle tube is prevented from accidentally leaving the inner space after the cover is transferred into the protection position. In other words, the retaining device is used to retain the needle tube so that the re-pivoting of the cover relative to the base after the needle tube is used for injection does not cause the needle tube to be released. Background Art
[0007] A universal protective device is known from WO 2021 / 008717 A1. The document describes a protective device comprising a cover, which includes a retaining device configured to reliably retain a needle tube. The retaining device includes two protrusions, which extend toward each other from the inner unfolded surface of the wall of the cover. Therefore, these protrusions are inclined relative to the pivot plane and are elastic, so that the needle tube can deform and displace these protrusions and thus interlock behind these protrusions. In this way, it is 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 protrusions, so that the needle tube is prevented from causing accidental harm to people.
[0008] Although the safety of known protection devices against accidental removal of the needle from the safety area is already quite high, intentional misoperation of the safety device is still possible and may cause the needle to leave the safety area after being used for an injection, which poses a risk of subsequent infection.
[0009] US 5,490,841 B1 discloses another protective device with a cover. The cover includes a retaining device, which includes a projection oriented at an oblique angle inside the cover. After reliable use, the cover encloses the needle tube in a safe area inside the cover, wherein the projection is configured to be flexible so that the projection is initially elastically deformable to allow the needle tube to enter the safe area. Deformation in the opposite direction that causes the needle tube to leave the safe area is prevented by a stopper arranged at a position opposite to the projection on the inner development surface of the wall of the cover.
[0010] This configuration is disadvantageous because the projection extends within the interior of the cover so that the projection can collide with the needle tube before being used for injection. This is disadvantageous in particular for the automated production of syringes that are configured with a needle carrier including a needle tube and a protective device, because the protective device cannot be easily mounted with its base on or at the needle carrier without causing the needle tube supported in the needle carrier to collide with the projection arranged in the interior of the cover. Summary of the invention
[0011] It is therefore an object of the present invention to provide a protection device which is adaptable to a needle carrier in a particularly simple manner and which also offers a high degree of safety against the needle cannula accidentally coming out of the cover after being used for an injection.
[0012] This object is achieved by a protective device having the features indicated in claim 1. Advantageous embodiments can be derived from the dependent claims.
[0013] The protection device according to the present invention is characterized in that the retaining device comprises a deformable projection, a stop associated with the projection and at least one supporting element. The projection is configured to be deformed by the needle tube when the cover is transferred to its protection position so that the projection is displaced in a first direction so that the needle tube can enter an internal safety area arranged behind the projection. In this way, the needle tube is interlocked behind the projection so that the projection retains the needle tube in the safety area and thus prevents accidental release of the needle tube. The stop is formed opposite to the projection at the inner encapsulation surface of the cover or its wall, and is configured so that when the projection is deformed by the needle tube in a second direction oriented opposite to the first direction, it contacts the lower contact surface of the stop, thereby preventing further deformation of the projection.
[0014] This prevents the needle cannula from accidentally leaving the safety zone. In the undeformed state, the projection extends from the inner encapsulating surface of the cover into the interior of the cover, wherein, in an advantageous embodiment, the projection forms a projection angle of at least 35° with the pivot plane in a cross section extending orthogonally to the longitudinal axis of the cover. Advantageously, the angle is at least 40°, further advantageously 45°.
[0015] At least one guide element is associated with the stopper and is configured to guide the needle cannula arranged in the safety area, thereby preventing the needle cannula from being present under the contact surface of the stopper after the needle cannula enters the safety area. In particular, the guide element can block the space under the stopper so that the needle cannula laterally contacts the guide element and thus cannot move into the space under the stopper. In this way, it is possible to prevent the needle cannula from moving under the stopper and then between the protrusion and the stopper after having entered the safety area, so that the needle cannula will leave the safety area again.
[0016] The safety device according to the invention has many advantages. In particular, the protective device ensures that the needle tube is safely kept in the cover after the needle tube has been used for injection and the cover has been pivoted into its protective position. The reason is that the needle tube can no longer leave the safety area after the needle tube has entered the safety area, since the temporary displacement of the elastic projection is required to enter the safety area. The movement of the needle tube in the direction of leaving the safety area inevitably causes the needle tube to contact the projection from the bottom side, which again elastically deforms the projection, but due to the matching geometry of the projection and the stopper that prevents further deformation of the projection, this deformation causes the projection to contact the contact surface of the stopper. At least one guiding element ensures that the needle tube contacts the bottom side of the projection and in particular cannot directly contact the stopper side of the stopper laterally from the projection. Experiments have shown that after the needle tube enters the safety area, it is impossible to remove the needle tube from the safety area even if the protective device is intentionally destroyed.
[0017] Therefore, another advantage of the present invention is that the protective device can be easily installed on the needle carrier provided with the needle tube. Therefore, when the cover is in its starting position, the needle tube is prevented from colliding with the projection of the cover. This is achieved by the inclination of the projection, which is quite steep relative to the pivot plane and according to the previous description is at least 35°. Known covers are inclined at a significantly flatter angle relative to the pivot plane and extend essentially centrally through the interior of the cover. However, when the cover is in its starting position, the needle tube fills this area, so that a collision of the needle tube with the flatter projection is most likely to occur during the installation of the cover.
[0018] Another advantage of the configuration according to the present invention is that the safety of resisting the needle tube from leaving the safe area is provided by the cooperation of the soft projection and the rigid stop. This helps that the projection itself can be configured to be relatively soft, which means that it has little rigidity because the projection itself cannot fix the needle tube. Therefore, since the projection is easily deformed when the needle tube contacts the bottom side of the projection, the smaller deformability of the projection will not damage the safety, but, due to the contact surface contact of the projection with the stop, the projection can be prevented from moving in the opposite direction. However, the easy deformability of the projection has a specific advantage: the protective device can also be used when a thin needle tube is used. In particular, the needle tube for example for insulin syringes has a particularly small diameter, making the needle tube particularly easy to deform. When the projection is configured to be hard as in the prior art so as to fix the needle tube in the safe area, the needle tube may not be able to displace the projection, but the projection will deform the needle tube. This will prevent the needle tube from reliably entering the safe area, which makes the syringe with the protective device unsafe. This lack of safety does not arise from the possibility that the needle tube may accidentally leave the safe area, but rather from the inability of the needle tube to reliably enter the safe area. The soft protrusion eliminates this risk.
[0019] In an advantageous embodiment of the protective device according to the present invention, a cross section of the cover orthogonal to the longitudinal axis of the cover shows an offset between the end of the undeformed protrusion oriented away from the inner encapsulation surface of the cover and the end of the stopper oriented toward the cover, wherein the offset is measured in a direction orthogonal to the pivot plane. In other words, in this embodiment, an offset measured orthogonally to the pivot plane is set between the end of the stopper oriented toward each other and the end of the protrusion. This offset is advantageously between 0.05mm and 0.25mm, and further advantageously in the range between 0.1mm and 0.2mm. Therefore, in this embodiment, the undeformed protrusion does not reach below the contact surface of the stopper. On the contrary, a minimum gap is set between the protrusion and the stopper, which helps the needle tube enter the safe area in the interior of the cover. In particular, only a small deformation of the protrusion is required so that the needle tube can enter the safe area and get stuck behind the protrusion. Such a configuration is therefore particularly advantageous in order to facilitate entry of the needle cannula into the safety region with relatively low forces acting on the needle cannula, so that the entry is particularly reliable and prevents the needle cannula from being accidentally deformed.
[0020] In addition, an embodiment of the protective device is particularly advantageous in which a cross section of the cover orthogonal to the longitudinal axis of the cover shows an offset between the end of the undeformed projection oriented away from the inner enveloping surface of the cover and the end of the stop oriented toward the projection, wherein the offset is measured in a direction parallel to the pivot plane. The offset is advantageously in the range between 0.20 mm and 0.80 mm, further advantageously between 0.20 mm and 0.70 mm, further advantageously between 0.30 mm and 0.60 mm. This embodiment also has the advantage that the entry of the needle tube into the safety zone is simplified, since the projection only needs to be displaced a minimum amount so that the needle tube is locked behind the projection. In principle, the needle tube can pass through the slit between the projection and the stop formed due to the above-mentioned offset and leave the safety zone in this way. However, this is prevented by a guide element, which guides the needle tube so that it cannot move under the stop and therefore cannot approach the provided slit. Therefore, movement of the needle tube in a direction away from the safety area causes the needle tube to contact the bottom side of the projection, which causes the projection to deform until the projection contacts the contact surface of the stopper.
[0021] Advantageously, at least one guide element extends from the inner enveloping surface of the cover into the interior. This is advantageous so that the space below the contact surface of the cover is completely blocked for the needle cannula. The associated advantages are described above.
[0022] It is particularly advantageous when the protective device comprises a plurality of guide elements, wherein, viewed in the longitudinal direction of the cover, at least one guide element is arranged in front of the stopper and at least one guide element is arranged behind the stopper. This configuration has the advantage that, when the needle tube is deformed, in particular bent along its longitudinal axis, the needle tube can be reliably prevented from moving into the space below the contact surface of the cover. Therefore, the space below the contact surface of the cover is blocked from both sides of the cover by two support elements, so that the needle tube cannot reach this space and is therefore reliably held under the projection.
[0023] In another embodiment of the protective device according to the invention, the cover has a U-shaped wall in a cross section orthogonal to the longitudinal axis of the cover, wherein the wall defines an inner space. Thus, the cover is advantageously configured so 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 sections of the cover may be at least substantially parallel at opposite inner enveloping surfaces, from which the projection extends on one side and from which the stop extends on the other side. A corresponding configuration can be derived from the subsequent embodiments. This configuration is particularly advantageous in order to ensure cooperation of the lug with the stop.
[0024] Advantageously, the protective device is configured such that the base and the cover are connected to each other in their starting position in a force-transmitting manner by a preset breaking joint ("original closure"). The preset breaking joint can be broken by applying wrist force, so that the cover can be pivoted into its operating position after the preset breaking joint is broken. This embodiment is particularly advantageous so that the needle tube is reliably supported in the cover before being used for injection, wherein the preset breaking joint prevents the cover from accidentally pivoting into the operating position and thus prevents the accidental release of the needle tube. In addition, it is not necessary to use a separate cover to protect the needle tube before the needle tube is used for injection, wherein the separate cover will be placed on the needle tube, for example, in the form of a closure cap. Instead, the function of protecting the needle tube can be performed by the cover itself before and after the needle tube is used for injection. This is particularly easy due to the above-mentioned configuration of the protrusion inclined at a steep angle relative to the pivot plane, because the risk of the needle tube colliding with the protrusion is eliminated during the assembly of the protective device at the needle-carrying part. When the preset breaking joint is broken, it becomes an indication that the needle tube may have been used. Therefore, the user of the protection device will no longer use the needle cannula without him or herself opening the protection device, which means that he or she has destroyed the intended breaking joint.
[0025] In another advantageous embodiment of the protective device according to the invention, the cover and the base are connected to each other by a foil hinge. The foil hinge is particularly well suited to establishing the pivotability of the cover relative to the base while providing an integral configuration of the protective device in a one-piece form. Therefore, it is particularly advantageous when the protective device is provided integrally in a one-piece form.
[0026] Furthermore, when the cover is in its starting position, a configuration of the protective device can be effectively advantageous in which the cover and the base are arranged coaxially relative to each other. In this embodiment, the longitudinal axes of the base and the cover are oriented parallel to each other. Advantageously, the longitudinal axis of the cover coincides with the longitudinal axis of the base.
[0027] Alternatively, or in addition, it can be particularly advantageous if, when the cover is in its protective position, the longitudinal axis of the base and the longitudinal axis of the cover are not oriented parallel to each other and therefore enclose an angle of greater than or equal to 0° relative to each other when the cover is pivoted in the second pivoting direction. This configuration has the advantage that the needle cannula can be brought into contact with the projection in a particularly simple manner by displacing the projection as described above so that the needle cannula eventually enters the safety zone in the interior of the cover. In embodiments in which the cover is inclined at different angles relative to the base between its starting position and its protective position, it is particularly simple to prevent a collision of the needle cannula with the cover when the protective device is mounted at the needle carrier, whereas such a collision is intentionally caused when the cover is transferred into the protective position in order to bring the needle cannula into the safety zone. Furthermore, the described embodiment has the advantage that the cover can be attached to the base in a particularly simple manner in order to fix the cover in its protective position, advantageously by using a positive positive lock.
[0028] It can therefore be particularly advantageous when at least one interlocking device is provided at the base, wherein the interlocking device cooperates with at least one interlocking fitting of the cover by positive positive locking, so that the cover is interlockable in the protection position. When the cover is moved into the protection position, the cooperation of the interlocking device with the interlocking fitting can be achieved in a particularly simple manner by pivoting the cover relative to the base beyond the starting position so that the interlocking fitting of the cover comes into contact with the interlocking device of the base. Due to the engagement of the interlocking fitting with the interlocking device, it is ensured that the cover cannot be accidentally moved from its protection position back into its operating position.
[0029] This object is also achieved by a kit having the features of claim 12. Advantageous embodiments can be derived from the associated dependent claims.
[0030] The kit comprises a protective device according to the invention as described above and a needle carrier having a needle tube supported therein. The base of the protective device is connected to the needle carrier by a forced shape lock, so that when the cover is in its starting position, the needle tube is oriented parallel to the longitudinal axis of the cover. When the cover is pivoted from its starting position to its operating position in a first pivot direction in a pivot plane, the needle tube is released for injection use. Subsequently, the cover can be pivoted back in a second pivot direction opposite to the first pivot direction in a direction toward the starting position so that the needle tube enters the interior of the cover again and is protected from accidental contact with a person. As described above, when the cover reaches its protective position, the cover is locked relative to the base, thereby preventing the cover from moving into the operating position again, which is particularly advantageous. Moving the cover into the protective position coincides with the needle tube entering the safety zone beyond the projection, wherein the projection is elastically deformed due to contact with the needle tube and is therefore displaced until the needle tube is stuck in a suitable position behind the projection and is thereafter arranged in the safety zone.
[0031] In a particularly advantageous embodiment of the kit according to the invention, at least when the cover is in its starting position, the base of the projection of the projection is arranged in a common plane with the needle tube, which common plane is perpendicular to the pivot plane, when seen in a section of the cover orthogonal to the longitudinal axis of the cover. The base of the projection thus denotes the proximal portion of the projection by which the projection is connected to the inner enveloping surface of the wall of the cover. The described embodiment has the advantage that a collision of the projection with the needle tube is prevented during mounting of the protective device at the needle carrier, since the needle tube and the base of the projection are at the same height level relative to the pivot plane of the cover. Since the projection extends at an angle relative to the pivot plane and the needle tube generally extends through the center of the inner space of the cover, the projection extends past the needle tube in the direction towards the pivot plane. This embodiment will be described below. BRIEF DESCRIPTION OF THE DRAWINGS
[0032] The present invention will now be described based on embodiments with reference to the accompanying drawings, in which:
[0033] Figure 1 A view of the protective device according to the invention is illustrated, wherein the cover is in a starting position;
[0034] Figure 2 illustrates a perspective cross-sectional view of a protective device according to claim 1;
[0035] Figure 3 The diagram shows Figure 1 A perspective view of a portion of a protective device;
[0036] Figure 4 The diagram shows Figure 1 A cross-sectional view of a protective device;
[0037] Figure 5 The diagram shows Figure 1 A view of the protective device, wherein the cover is in the operating position;
[0038] Figure 6 The diagram shows Figure 5 A perspective view of a protective device;
[0039] Figure 7 The diagram shows Figure 1 A perspective view of a portion of a protective device of , wherein the cover is in a protective position; and
[0040] Figure 8 The diagram shows Figure 7 A cross-sectional view of a cover of a protective device. DETAILED DESCRIPTION
[0041] Figures 1 to 8 The embodiment illustrated in comprises a protection device 1 comprising a base 3 and a cover 4. The cover 4 is configured to be pivotable relative to the base 3, wherein the cover 4 is connected at the base 3 by a foil hinge 22. The protection device 1 is configured integrally as a single piece and is manufactured as an injection molded part.
[0042] The base 3 is configured to cooperate with a needle carrier 25 supporting the needle cannula 2. The needle cannula 2 is particularly glued into a complementary recess of the needle carrier 25 so that the longitudinal axis of the elongated needle cannula 2 extends parallel to the longitudinal axis 31 of the base 3. This is particularly due to Figure 1 is visible in.
[0043] The protection device 1 is integrally mounted at the needle carrier 25, which is advantageously performed automatically. During assembly, the protection device 1 is in a starting position, in which the cover 4 is in a starting position. In this starting position, the cover 4 is attached to the base 3 by means of a pre-set breaking joint 21, so that pivoting of the cover 4 relative to the base 3 is prevented. When the cover 4 is in its 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 axis 5 of the cover 4 and the longitudinal axis 31 of the base 3 coincide.
[0044] After the protective device 1 is mounted on the needle carrier 25, the needle tube 2 is arranged in the inner space 6 of the cover 4, which is enclosed by the wall 30 of the cover 4. Figure 2 Supporting the needle cannula 2 in the cover 4 has the following advantages: a person handling the syringe including the needle carrier 25 is protected from the needle tip 35 of the needle cannula 2. The cover 4 is prevented from pivoting relative to the base 3 by the pre-set breaking joint 21, preventing accidental release of the needle cannula 2.
[0045] In order to enable the needle tube 2 to be used for injection, the needle tube 2 needs to be released. Therefore, the user of the syringe can break the cover 4 from the base 3 by applying wrist force at the gripping protrusion 33 of the cover 4, so that the preset breaking joint 21 is destroyed. This releases the cover 4 from the base 3 using the foil hinge 22. Therefore, by pivoting the cover 4 in the first pivot direction within the rotation plane 8, the cover 4 can be moved into its operating position, so that the needle tube 2 is released into the operating position. Therefore, the cover 4 can be pivoted relative to the base 3 in the pivot plane 8, wherein the wall 30 of the cover 4 is open at one side in the pivot plane 8, so that the needle tube 2 can easily leave from the inner space 6 during the pivoting of the cover 4. This Figure 2 In the illustrated embodiment, the wall 30 is configured in a U-shape, wherein the vertical axis 20 of the cross section of the wall 30 is oriented parallel to the pivot axis 8 and orthogonal to the longitudinal axis 5 of the cover 4 .
[0046] When the cover 4 is in Figure 5 and Figure 6 4, the needle tube 2 is released according to the above description so that the needle tube 2 is ready for injection. In the illustrated embodiment, the base 3 is provided with an interlocking device 23, which is configured to cooperate with an interlocking fitting 24 configured at the cover 4. Thereby, the interlocking device 23 and the interlocking fitting 24 can form a positive locking connection with each other, so that the cover 4 can be interlocked at the base when the cover 4 is in its operating position. In this way, when the needle tube 2 is used for injection, uncontrolled use of the cover 4 (which will make the user of the syringe uncomfortable) can be prevented.
[0047] After the injection is performed using the needle cannula 2, the cover 4 is pivoted back from its operating position to the base 3 in a second pivoting direction opposite to the first pivoting direction until the cover 4 is in the protective position. For the protective position of the cover 4, it is important to pivot the cover 4 back far enough in the second pivoting direction so that the needle cannula 2 enters the interior 6 of the cover 4 again and the needle cannula 2 is protected from accidental contact with a person. Since the needle cannula 2 may come into contact with the blood of a person who has been injected with a medicament by the syringe, it is important to protect it from subsequent contact with the needle cannula 2. Therefore, it is necessary that the cover 4 accommodates the needle cannula 2 after being moved into the protective position so that the needle cannula 2 cannot be accidentally released thereafter.
[0048] To facilitate this, the cover 4 comprises a retaining device 9 comprising a projection 10, a stop 11, and two guide elements 12, 13. In particular, the retaining device 9 is formed from a projection 10, a stop 11, and two guide elements 12, 13. Figure 4 and Figure 8When the cover 4 is in its starting position, the needle tube 2 is arranged in the portion of the inner space 6 formed on the proximal side of the projection 10, and is therefore arranged outside the safety area 7 of the inner space 6. In this case, since the needle tube 2 has not been used for injection, it will not hinder the needle tube 2 from leaving the inner space 6. According to the above description, the cover 4 is configured to be moved into the operating position in which the needle tube 2 is released for use.
[0049] During the pivoting of the cover 4 from the operating position back into the protective position, the retaining device 9 reliably retains the needle tube 2 in the interior 6 of the cover 4. Therefore, in the illustrated embodiment, the cover 4 is pivoted in the second pivoting direction beyond the starting position, so that the longitudinal axis 5 of the cover 4 and the longitudinal axis 31 of the base 3 enclose an angle 32 relative to each other and are therefore not oriented parallel to each other. Therefore, in the illustrated embodiment, the angle 32 is about 20°. This movement of the cover 4 allows the needle tube 2 to enter the interior space 6 again not only at the opening side of the wall 30 of the cover 4, but also into the safety area 7 away from the protrusion 10. This is due to the fact that when the protrusion 10 first comes into contact with the needle tube 2, the protrusion 10 is deformed due to its elasticity and the protrusion 10 is displaced. Starting from the predetermined position of the cover 4, the needle tube 2 is stuck in the appropriate position behind the protrusion 10, which then deforms back to its initial shape. This situation is from Figure 8 is visible in.
[0050] The movement of the needle cannula 2 from the safety area 7 is therefore no longer possible. This is due to the fact that, even under the forced movement of the cover 4 in the first pivoting direction, the needle cannula 2 itself contacts the bottom side of the projection 10 towards the operating position, which causes the projection 10 to deform elastically in the direction towards the opening side of the wall 30. During this deformation, the projection 10 (at least the end 16 of the projection 10 directed away from the wall 30) contacts the lower contact surface 34 of the stop 11, thereby preventing further deformation of the projection 10. In the illustrated embodiment, this type of cooperation between the projection 10 and the stop 11 is achieved, wherein the projection 10 and the stop 11 extend from opposite inner enveloping surfaces 14 of the wall 30 of the cover 4. The guide elements 12, 13 arranged on both sides of the stop 11 along the longitudinal axis 5 of the cover 4 and associated with the stop 11 prevent the needle cannula 2 from moving in the space below the stop 11 after entering the safety area 7. Therefore, the needle tube 2 cannot directly contact the contact surface 34 of the stopper 11. Thus, this prevents the needle tube 2 from moving from one side of the projection 10 to the area above the end 16 of the projection 10 and escaping from the safety area 7.
[0051] According to the invention, in the illustrated embodiment, the projection 10 extends at a projection angle 15 relative to the pivot plane 8, which projection angle 15 is 40°. In addition, the projection 10 is arranged at the wall 30 relative to the needle tube 2 so that when the cover 4 is in its starting position, the projection base 26 is substantially at the same height level as the needle tube 2. Therefore, when the cover 4 is in its starting position, the projection base 26 and the needle tube 2 are in a common plane 27, wherein the common plane 27 is perpendicular to the pivot plane 8. When the protective device 1 is mounted at the needle carrier 25, this configuration helps to exclude a collision between the needle tube 2 and the projection 10. This is because Figure 4 It is clearly visible in Figure 4 The corresponding offset between the needle cannula 2 and the projection 10 is clearly shown.
[0052] In order to further simplify the entry of the needle cannula 2 into the safety zone 7, it is provided in the present embodiment that an offset 18 measured perpendicular to the pivot plane 8 is provided between the end 16 of the projection 10 oriented toward the projection base 26 and the end 17 of the stop 11 oriented toward the projection 10. In other words, a gap is provided between the projection 10 and the stop 11, seen in a direction orthogonal to the pivot plane 8. The same applies to the direction parallel to the pivot plane 8, wherein an offset 19 is provided between the two ends 16, 17 of the projection 10 and the stop 11. In the illustrated embodiment, the offset 18 measured orthogonally to the pivot plane 8 is 0.15 mm, while the offset 19 is approximately 0.040 mm. This embodiment has proven to be particularly useful in order to minimize the risk of collision between the projection 10 and the needle cannula 2, to facilitate an easy transition of the needle cannula 2 into the safety zone 7, and also to allow a reliable stop of the projection 10 at the contact surface 34 of the stop 11. It is evident that the force exerted by the needle 2 on the projection 10 in order to deform the projection 10 so that the needle 2 can enter the safety zone 7 is particularly small relative to the needle 2 entering the safety zone 7. This has the advantage that the protective device 1 is also suitable for the injection of substances that are injected with a needle 2 having a particularly small diameter. In particular, this applies to insulin injections using a needle 2 having a diameter of less than 0.2 mm.
[0053] Particularly advantageously, the protective device 1 comprises, in addition to the guide elements 12, 13, additional guide elements 28, wherein the additional guide elements 28 are arranged in the interior space 6, distributed along the longitudinal axis 5 of the cover 4. The guide elements 28, like the guide elements 12, 13, extend from the inner enveloping surface 14 of the wall 30 of the cover 4. This Figure 1 It is clearly visible.
[0054] Furthermore, in the illustrated embodiment, the base 3 comprises a safety element 29, such as Figure 3 and Figure 7When the cover 4 is moved into its protective position, the safety element 29 locks the cover 4 at the base 2 by forced shape locking, thereby preventing the cover 4 from accidentally pivoting back into the operating position in the first pivot direction. This would require intentional application of force on the cover 4 in order to disengage the shape lock with the safety element 29. Even in this case, the needle cannula 2 will not be released because the needle cannula 2 is reliably held in the safety area 7 of the interior 6 by the holding device 9. Tests have shown that in this case, the needle cannula 2 bends and deforms.
[0055] Reference Symbols and Names
[0056] 1. Protective device
[0057] 2 Needle
[0058] 3 Base
[0059] 4 Cover
[0060] 5 Longitudinal axis
[0061] 6. Internal Space
[0062] 7 Safe Area
[0063] 8 Pivot plane
[0064] 9. Holding device
[0065] 10. Protrusion
[0066] 11 Stopper
[0067] 12 Guide elements
[0068] 13 Guide element
[0069] 14 Encapsulation Surface
[0070] 15 Protrusion angle
[0071] 16 end
[0072] 17 end
[0073] 18 Offset
[0074] 19 Offset
[0075] 20 Vertical axis
[0076] 21 Preset fracture joints
[0077] 22 Foil Hinge
[0078] 23 Interlocking device
[0079] 24 interlocking parts
[0080] 25 Needle carrier
[0081] 26 protrusion base
[0082] 27 plane
[0083] 28 Guide element
[0084] 29 Security Element
[0085] 30 wall
[0086] 31 Longitudinal axis
[0087] 32 corners
[0088] 33 Grasping protrusion
[0089] 34 Contact surface
[0090] 35 Needle Tip
Claims
1. A protective device (1) for a needle tube (2) of a syringe, the protective device comprising: - base (3); as well as - a cover (4) connected to the base (3), The base (3) is configured to cooperate with the needle carrier (25) by forced shape locking, wherein the needle carrier (25) supports the needle tube. The cover (4) is configured to be elongated along a longitudinal axis (5) and define an internal space (6), wherein the needle tube (2) can be stored in the internal space (6), thereby protecting a person from accidental contact with the needle tube (2). wherein the cover (4) is pivotably supported on the base (3) so that the cover (4) can be transferred relative to the base (3) in a pivot plane (8) from a starting position in a first pivot direction into an operating position in which the needle tube (2) is stored in the inner space (6) before being used for injection, in the operating position in which the needle tube (2) can be used for injection, and finally, the cover (4) can be transferred in a second pivot direction opposite to the first pivot direction into a protective position in which the needle tube (2) is stored again in the inner space (6) after being used for injection, wherein one side of the cover (4) is open in the pivot plane (8), so that the needle tube (2) is configured to initially leave the inner space (6) for injection due to the pivotal movement of the cover (4), and is configured to re-enter the inner space (6) after being used for injection, The cover (4) comprises a retaining device (9) located in the inner space (6), wherein the retaining device is configured to interlock the needle tube (2) by forced shape locking during the process of transferring the cover (4) into the protection position, thereby preventing the needle tube (2) from accidentally leaving the inner space (6) after the cover (4) is completely transferred to the protection position. The invention is characterized in that the holding device (9) comprises a deformable protrusion (10), a stopper (11) associated with the protrusion (10), and at least one guiding element (12, 13), The projection (10) is configured to be deformed by the needle tube (2) and displaced in a first direction during the process of transferring the cover (4) into its protective position, so that the needle tube (2) can enter a safety area (7) arranged behind the projection (10), in which the needle tube (2) is interlocked behind the projection (10), The stopper (11) is arranged at an inner encapsulation surface (14) of the cover (4) opposite to the protrusion (10), so that the protrusion (10) contacts the contact surface (34) of the stopper (11) in a second direction opposite to the first direction when deformed by the needle tube (2), thereby preventing the needle tube (2) from accidentally leaving the safety area (7). The guide elements (12, 13) are associated with the stopper (11) and are configured to guide the needle tube (2) so as to prevent the needle tube (2) from being below the stopper surface (34) of the stopper (11) after the needle tube (2) enters the safety area (7).
2. The protection device (1) according to claim 1, characterized in that The projection (10) in an undeformed state extends from the inner enveloping surface (16) of the cover (4) into the interior space (6), and when viewed in a cross section orthogonal to the longitudinal axis (5) of the cover (4), the projection in an undeformed state defines a projection angle (15) of at least 35°, advantageously at least 37.5°, more advantageously at least 40° with the pivot plane (8).
3. The protection device (1) according to one of the preceding claims, characterized in that In a cross section of the cover (4) orthogonal to the longitudinal axis (5) of the cover (4), an offset (18) measured in a direction orthogonal to the pivot plane (8) is arranged between an end (16) of the undeformed protrusion (10) oriented away from the inner encapsulating surface (14) of the cover (4) and an end (17) of the stop member (11) oriented toward the protrusion (10), wherein the offset (18) is advantageously in the range between 0.05 mm and 0.25 mm, advantageously in the range between 0.10 mm and 0.20 mm.
4. The protection device (1) according to one of the preceding claims, characterized in that In a cross section of the cover (4) orthogonal to the longitudinal axis (5) of the cover (4), an offset (19) is provided between an end (16) of the undeformed protrusion (10) oriented away from the inner encapsulating surface (14) of the cover (4) and an end (17) of the stop member (11) oriented toward the protrusion (10), wherein the offset (19) is measured in a direction parallel to the pivot plane (8), wherein the offset (19) is advantageously in the range between 0.20 mm and 0.80 mm, advantageously between 0.25 mm and 0.70 mm, further advantageously in the range between 0.30 mm and 0.60 mm.
5. Protection device (1) according to one of the preceding claims, characterized in that The at least one supporting element (12, 13) extends from the inner envelope surface (14) of the cover (4) into the interior space (6).
6. Protection device (1) according to one of the preceding claims, characterized in that It comprises a plurality of guide elements (12, 13), wherein, advantageously, seen in the longitudinal direction of the cover (4), at least one guide element (12) is arranged in front of the stopper (10), and at least one guide element (13) is arranged behind the stopper (10).
7. Protection device (1) according to one of the preceding claims, characterized in that In a section orthogonal to the longitudinal axis (5) of the cover, the cover (4) is configured in a U-shape, wherein the vertical axis (20) of the section is advantageously oriented parallel to the pivot plane (8) of the cover (4).
8. Protection device (1) according to one of the preceding claims, characterized in that When the cover (4) is in its starting position, the base (3) and the cover (4) are connected to each other via a preset breaking joint (21), wherein the preset breaking joint (21) can be broken by wrist force, so that after the preset breaking joint (21) is broken, the cover (4) can be pivoted to its operating position.
9. Protection device (1) according to one of the preceding claims, characterized in that The cover (4) and the base (3) are connected to each other via a film hinge (22).
10. Protection device (1) according to one of the preceding claims, characterized in that The cover (4) and the base (3) are arranged coaxially in their starting position, wherein the cover (4) is advantageously pivoted in the second pivot direction beyond the starting position when the cover (4) is in its protective position.
11. Protection device (1) according to one of the preceding claims, characterized in that An interlocking device (23) is arranged at the base (3), wherein the interlocking device is configured to engage with an interlocking fitting (24) of the cover (4) by positive shape locking, so that the cover (4) can be interlocked in the protective position.
12. A kit comprising a protection device (1) according to one of the preceding claims and a needle carrier (25) in which a needle cannula (2) is supported, wherein: The base (3) of the protective device (1) is connected to the needle carrier (25) by positive form locking, so that when the cover (4) is in its starting position, the needle tube (2) is oriented parallel to the longitudinal axis (5) of the needle tube (2).
13. The kit according to claim 12, characterized in that Viewed in a cross section of the cover (4) orthogonal to the longitudinal axis (5) of the cover (4), when the cover (4) is in its starting position, the protrusion base (26) of the protrusion (10) connected to the protrusion (10) at the inner enveloping surface (14) of the cover (4) and the needle tube (2) are arranged in a common plane perpendicular to the pivot plane (8).
Citation Information
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