Container with plunger and locking arrangement

Abstract

To provide a medical syringe which solves the problem that when the medical syringe is filled with a pharmaceutical and stored at a low temperature, the syringe often shows a large motion of the plunger during a cooling / thawing process.SOLUTION: A container 100, in particular a syringe or a cartridge, includes a container body 110, a plunger 130 having a plunger rod 132 disposed at least partially within the container body, and a locking arrangement 150 for locking a position of the plunger rod relative to the container body.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present application relates to a container, particularly a syringe or a cartridge, including a container body, a plunger, and a locking device.

[0002] Background Medical syringes often exhibit significant movement of the plunger during the cooling and melting process, especially when the syringe is filled with a drug and stored at a low temperature. This movement is mainly due to the thermal expansion and contraction of the contents of the syringe during temperature changes and the resulting pressure difference between the inside of the syringe and the environment.

[0003] The movement of the plunger poses a risk to the sterility of the syringe contents. For example, the stroke of the plunger due to the movement of the plunger typically forms the distal end of the plunger and often has a plurality of elastic sealing ribs, and may exceed the tolerance limit of the stopper that provides a certain tolerance range for the movement of the plunger without compromising sterility. The sterility of the syringe contents is assumed to be lost when, in some situations, the position of the inner wall of the syringe located outside the volume surrounded by the stopper is in a region within the length range of the stopper that is considered to be surrounded by the stopper or not safely sealed in another situation, or vice versa. Therefore, an inappropriate selection of the plunger may result in a loss of sterility in subsequent applications.

[0004] Selecting a plunger according to the characteristics of the tolerance range according to the temperature requirements of the intended contents of the syringe has proven to be inconvenient in many supply and manufacturing situations. Furthermore, glass syringes often do not meet the requirements for container complete closure integrity (CCI) at extremely low temperatures, such as about -80°C, which is the typical storage temperature of various vaccines.

[0005] Therefore, a technique is desired to avoid or at least mitigate at least one of the above-mentioned drawbacks.

[0006] Summary of the Invention Therefore, the container described in claim 1 is provided.

[0007] According to a first embodiment, a container, in particular a syringe or cartridge, is provided. The container includes a container body, a plunger having a plunger rod at least partially located within the container body, and a locking device for locking the position of the plunger rod relative to the container body. The locking device is operable between at least a locked position and an unlocked position. The locking device has at least one deformable member, which is configured to apply a locking force between the plunger rod and the inner wall of the container body when the locking device is in the locked position, and to release the locking force between the plunger rod and the inner wall of the container body when the locking device is switched from the locked position to the unlocked position.

[0008] This effectively reduces the movement of the plunger. Furthermore, the airtightness of the container can be enhanced by the seal between the plunger rod and the inner wall of the container. Moreover, the switching of the locking device from the locked position to the unlocked position may be reversible. In other words, the locking device is repeatable. Furthermore, the force required to move the plunger rod when the locking device is in the locked position, applied in the direction of operation of the plunger rod, can be adjusted by appropriately adjusting the locking force.

[0009] The locking device may be at least substantially attached to the plunger rod. Furthermore, each part of the locking device may be formed integrally with the plunger rod.

[0010] A deformable member may be positioned to extend along the inner circumference of the container body. The inner circumference of the container body may be substantially circular, and the deformable member may have a substantially circular shape. As one alternative, the inner circumference of the container body may be substantially polygonal, and the deformable member may have a substantially polygonal shape. As another alternative, the inner circumference of the container body may be substantially elliptical, and the deformable member may have a substantially elliptical shape. Furthermore, the deformable member may extend adjacent to the inner wall of the container body in the longitudinal direction of the container body, particularly in the axial direction and / or angular direction.

[0011] The deformable member may further be configured to seal the gap between the inner wall of the container body and the plunger rod when the locking device is in the locked position.

[0012] The locking device may further have a lateral projection extending from a portion of the plunger rod. Furthermore, the deformable member may be positioned to be pressed toward the lateral projection when the locking device is in the locked position.

[0013] The locking device may further include a sliding member, which is movable relative to the plunger rod and is configured to apply a pressing force toward the lateral projection to the deformable member when the locking device is in the locked position.

[0014] Lateral projections and / or sliding members may be configured to cause deformation and / or displacement of at least a portion of the deformable member toward the inner wall of the container when the locking device is in the locked position. Lateral projections may extend from the plunger rod. Furthermore, the sliding member may include a tube through which the plunger rod extends at least partially.

[0015] The locking device may further have at least one actuator configured to move a sliding member toward a deformable member when bringing the locking device to the locked position, and / or to keep the locking device releasable in the locked position. The actuator may have at least one wedge portion.

[0016] The actuating member may be positioned between the sliding member and the thumb rest of the plunger rod. The actuating member may be formed at least partially integrally with the sliding member at the proximal end of the sliding member facing the thumb rest of the plunger rod. Additionally or alternatively, the actuating member may be formed at least partially integrally with the thumb rest of the plunger rod, and the thumb rest may be movable relative to the lateral projection.

[0017] The locking device may have a plurality of interchangeable actuaries, at least two of which differ in terms of the distance the sliding member moves relative to the plunger rod when each actuary is used and operated. The plurality of actuaries may have a plurality of pins, at least two of which differ in terms of thickness. The plurality of actuaries may be interchangeable to adjust the total release force and / or total sliding force of the plunger. The total release force and total sliding force of the plunger may include the release force and sliding force of a stopper attached to the plunger rod, and the locking force generated by the locking device, respectively.

[0018] The container may contain polymer and / or glass. The container may be uncoated or silicone-free coated, particularly on its inner surface, and more specifically in the area that contacts the deformable member when the locking device is in the locked position. The material of the deformable member may contain silicone. Alternatively, the deformable member may be silicone-free and may contain rubber in particular. Additionally or alternatively, the deformable member may be silicone oil-free coated, preferably liquid-free coated, or more preferably uncoated. The plunger may be coated with polytetrafluoroethylene (PTFE). The container, including the container body, plunger, and locking device, may be silicone-free.

[0019] The container may be a drug container, particularly a syringe or cartridge.

[0020] The containers can be pre-filled.

[0021] The deformable member may be configured to seal the gap between the inner wall of the container body and the plunger rod against a pressure difference of at least 500 millibars, preferably at least 600 millibars, and more preferably at least 800 millibars, at a temperature of -80°C.

[0022] The locking device may be configured to reduce the movement of the plunger rod relative to the container body to less than 3 millimeters, preferably less than 2 millimeters, and more preferably less than 1.5 millimeters, when a pressure difference of 800 millibars is applied at a temperature of -80°C.

[0023] The deformable member may have a Shore hardness in the range of 25 to 80 Shore A, preferably in the range of 25 to 50 Shore A, and more preferably in the range of 30 to 35 Shore A.

[0024] The locking device may be configured to apply a locking force in the range of 5 to 15 Newtons. The locking force may be defined as a force applied in the operating direction of the plunger rod and required to move the plunger rod, and may be adjusted for other forces, in particular the release force and / or sliding force of a stopper attached to the plunger rod.

[0025] In particular, the container may be a syringe with a full capacity in the range of 0.8 to 2 milliliters, the release force of the stopper attached to the plunger rod may be less than 12 Newtons, the sliding force of the stopper may be less than 7 Newtons, and the locking force of the locking device may be in the range of 12 to 25 Newtons. Alternatively, the container may be a syringe with a full capacity in the range of 8 to 20 milliliters, the release force of the stopper attached to the plunger rod may be less than 35 Newtons, the sliding force of the stopper may be less than 20 Newtons, and the locking force of the locking device may be in the range of 20 to 30 Newtons. Another alternative is that the container may be a syringe with a full capacity in the range of 30 to 60 milliliters, the release force of the stopper attached to the plunger rod may be less than 45 Newtons, the sliding force of the stopper may be less than 25 Newtons, and the locking force of the locking device may be in the range of 30 to 45 Newtons.

[0026] When the locking device is in the unlocked position, the contact length between the deformable member and the inner wall of the container body may be in the range of 0 to 1 millimeter, preferably 0 millimeters. Alternatively, when the locking device is in the locked position, the contact length between the deformable member and the inner wall of the container body may be in the range of 2 to 20 millimeters, preferably 3 to 4 millimeters.

[0027] The deformable member may have a single annular contact area with the inner wall of the container body when the locking device is in the locked position.

[0028] When the locking device is in the locked position, the contact area of the deformable member with the inner wall of the container body may be larger than when the locking device is in the unlocked position.

[0029] The container body may be transparent in the range of the contact area of the deformable member with the inner wall of the container body. Further, when viewed through the container body, the surface of the deformable member may appear darker when it is in contact with the contact area than when it is in a non-contact state.

[0030] The plunger may further have a stopper attached to the plunger rod. The material of the stopper and the material of the deformable member may not be the same. The material of the stopper may include rubber, preferably bromobutyl rubber or ethylene propylene diene monomer (EPDM) rubber.

[0031] The deformable member may not be in direct contact with the stopper. In this case, the lateral protrusion may extend between the deformable member and the stopper. Alternatively, the deformable member may be in direct contact with the stopper. In this case, the stopper, particularly the proximal portion of the stopper, may at least partially constitute the lateral protrusion.

[0032] While the locking device is in the locked position, the following parameters can be met: namely: the full capacity of the container body is 0.5 to 100 milliliters, preferably 1 to 20 milliliters, and more preferably 1 to 5 milliliters; the container is pre-filled with liquid, preferably 10% to 90%, more preferably 20% to 80%, more preferably 30% to 70%, more preferably 40% to 60%, of the full capacity of the container, and more preferably a liquid containing additional sugar or salt; the container has a headspace of 0 to 10 millimeters, preferably 0.5 to 5 millimeters, more preferably 1 to 4 millimeters, and more preferably 1.5 to 3 millimeters, for gas, preferably air. Furthermore, under the following test conditions, namely: the pressure on the outside of the container relative to the inside is reduced by 100-1000 millibars, preferably 200-900 millibars, more preferably 300-800 millibars, more preferably 400-600 millibars, or more preferably 430 millibars over a period of 1 second to 1 week, preferably 1 minute to 24 hours, more preferably 1 hour to 6 hours, or more preferably 30 minutes to 24 hours, or the container is subjected to the following test conditions: The amount of movement of the plunger rod after one or both of the following test conditions are applied: storage at -210°C to 25°C, preferably -120°C to 0°C, more preferably -100°C to -15°C, more preferably -90°C to -40°C, or more preferably -80°C for 1 to 6 hours, more preferably 180 minutes, may be 3 millimeters or less, preferably 2 millimeters or less, more preferably 1 millimeter or less, more preferably 0.5 millimeters or less, or more preferably 0 millimeters.

[0033] Preferred Embodiment Embodiments according to the following items are particularly preferred.

[0034] Item 1. Containers (100; 700), especially syringes or cartridges, The container body (110) and A plunger (130;530;630) having plunger rods (132;332;432;532;632) at least partially located within the container body (110), A locking device (150;350;450;550;650) for locking the position of the plunger rods (132;332;432;532;632) relative to the container body (110) and It has, The locking device (150;350;450;550;650) is operable between at least a locked position and an unlocked position, and the locking device (150;350;450;550;650) has at least one deformable member (152;352;452), and the deformable member (152;352;452) is plastic when the locking device (150;350;450;550;650) is in the locked position. The system is configured to apply a locking force between the plunger rods (132;332;432;532;632) and the inner wall (112) of the container body (110), and to release the locking force between the plunger rods (132;332;432;532;632) and the inner wall (112) of the container body (110) when the locking device (150;350;450;550;650) is switched from the locked position to the unlocked position. It is characterized by the following:

[0035] Item 2. The container described in Item 1, with a locking device (150; 350; 450; 550; 650) attached to a plunger rod (132; 332; 432; 532; 632).

[0036] Item 3. The container according to item 1 or 2, wherein the deformable members (152; 352; 452) are arranged to extend along the inner circumference of the container body (110).

[0037] Item 4. The container according to Item 3, wherein the inner circumference of the container body (110) is substantially circular and the deformable members (152;352;452) are substantially circular, or the inner circumference of the container body (110) is substantially polygonal and the deformable members (152;352;452) are substantially polygonal.

[0038] Item 5. The container according to any one of items 1 to 4, wherein the deformable member (152;352;452) is further configured to seal the gap between the inner wall of the container body (110) and the plunger rod (132;332;432;532;632) when the locking device (150;350;450;550;650) is in the locked position.

[0039] Item 6. The container according to any one of items 1 to 5, wherein the locking device (150;350;450;550;650) further has a lateral projection (160;360;460) extending from a portion of the plunger rod (132;332;432;532;632), and when the locking device (150;350;450;550;650) is in the locked position, the deformable member (152;352;452) is positioned to be pressed toward the lateral projection (160;360;460).

[0040] Item 7. The container according to Item 6, wherein the locking device (150;350;450;550;650) further has a sliding member (154;354;554;654), the sliding member (154;354;554;654) is movable relative to the plunger rod (132;332;432;532;632), and when the locking device (150;350;450;550;650) is in the locked position, it is configured to apply a pressing force to the deformable member (152;352;452) toward the lateral projection (160;360;460).

[0041] Item 8. The container according to item 6 or 7, wherein the lateral projections (160;360;460) and / or sliding members (154;354;554;654) are configured to cause deformation and / or displacement of at least a portion of the deformable member (152;352;452) toward the inner wall (112) of the container (110) when the locking device (150;350;450;550;650) is in the locked position.

[0042] Item 9. The container according to any one of items 6 to 8, wherein the lateral projections (160; 360; 460) extend from the plunger rods (132; 332; 432; 532; 632), and the sliding members (154; 354; 554; 654) have tubes in which the plunger rods (132; 332; 432; 532; 632) extend at least partially.

[0043] Item 10. The container according to any one of items 7 to 9, wherein the locking device (150;350;450;550;650) further has at least one actuating member (170;570;670) configured to move a sliding member (154;354;554;654) toward a deformable member (152;352;452) when bringing the locking device (150;350;450;550;650) to the locked position, and / or to keep the locking device (150;350;450;550;650) in a releaseable position.

[0044] Item 11. The container according to Item 10, wherein at least one operating member (170; 570) has at least one wedge portion (172; 558, 572).

[0045] Item 12. The vessel according to item 10 or 11, wherein the operating member (170; 570; 670) is positioned between the sliding member (154; 354; 554; 654) and the thumb rest (138) of the plunger rod (132; 332; 432; 532; 632).

[0046] Item 13. The container according to item 10 or 11, wherein at least one actuating member (558, 570; 658, 670) is formed integrally with the sliding member (554; 654) at least partially at the proximal end (558; 658) of the sliding member (554; 654) facing the thumb rest (538; 638) of the plunger rod (532; 632), and / or the actuating member (570, 572; 670, 672) is formed integrally with the thumb rest (538; 638) of the plunger rod (532; 632), and the thumb rest (538; 638) is preferably movable relative to the lateral projection (160; 360; 460).

[0047] Item 14. The container body (110) is a container described in any one of items 1 through 13, comprising polymer and / or glass.

[0048] Item 15. The container according to any one of items 1 to 14, wherein the container body (110) is uncoated or silicone-free coated in the area that contacts the deformable member (152; 352; 452) when the locking device (150; 350; 450; 550; 650) is in the locked position.

[0049] Item 16. The container according to any one of items 1 to 15, wherein the material of the deformable member (152;352;452) contains silicone, and / or the deformable member (152;352;452) is coated with a silicone oil-free coating, preferably a liquid-free coating, or more preferably uncoated.

[0050] Item 17. Container (100;700) is a container described in any one of items 1 through 16, which is a drug container, in particular a syringe or cartridge.

[0051] Item 18. The container (700) is a pre-filled container as described in any one of items 1 through 17.

[0052] Item 19. The container according to item 5 and any one of items 1 to 18, wherein the deformable member (152; 352; 452) is configured to seal the gap between the inner wall of the container body (110) and the plunger rod (132; 332; 432; 532; 632) to a pressure difference of at least 500 millibars, preferably at least 600 millibars, and more preferably at least 800 millibars at a temperature of -80°C.

[0053] Item 20. The container according to any one of items 1 to 19, wherein the locking device (150) is configured to reduce the movement of the plunger (130) relative to the container body (110) to less than 3 millimeters, preferably less than 2 millimeters, more preferably less than 1.5 millimeters, or more preferably less than 0.5 millimeters when a pressure difference of 500 millibars, preferably 600 millibars, or more preferably 800 millibars is applied at a temperature of -20°C, preferably -50°C, more preferably -80°C.

[0054] Item 21. The deformable member (152;352;452) has a Shore hardness in the range of 25 to 80 Shore A, preferably in the range of 25 to 50 Shore A, and more preferably in the range of 30 to 35 Shore A, as described in any one of items 1 to 20.

[0055] Item 22. A locking device (150; 350; 450; 550; 650) configured to apply a locking force in the range of 5 to 15 Newtons, as described in any one of items 1 through 21.

[0056] Item 23. A container according to any one of items 1 to 22, wherein when the locking device (150;350;450;550;650) is in the unlocked position, the contact length (L_C) between the deformable member (152;352;452) and the inner wall (112) of the container body (110) is in the range of 0 to 1 millimeter, preferably 0 millimeters, and / or when the locking device (150;350;450;550;650) is in the locked position, the contact length (L_C) between the deformable member (152;352;452) and the inner wall (112) of the container body (110) is in the range of 2 to 20 millimeters, preferably 3 to 4 millimeters.

[0057] Item 24. The container according to any one of items 1 to 23, wherein the deformable member (152; 352; 452) has a single annular contact area with the inner wall (112) of the container body (110) when the locking device (150; 350; 450; 550; 650) is in the locked position.

[0058] Item 25. A container according to any one of items 1 to 24, wherein when the locking device (150;350;450;550;650) is in the locked position, the contact area between the deformable member (152;352;452) and the inner wall (112) of the container body (110) is larger than when the locking device (150;350;450;550;650) is in the unlocked position.

[0059] Item 26. A container according to any one of items 1 to 25, wherein the container body (110) is transparent in the area of ​​contact between the deformable members (152;352;452) and the inner wall (112) of the container body (110), and the surface of the deformable members (152;352;452), when viewed through the container body (110), appears darker when in contact with the contact area than when not in contact.

[0060] Item 27. The container according to any one of items 1 to 26, wherein the plunger (130; 530; 630) further has a stopper (134) attached to the plunger rod (132; 332; 432; 532; 632), and preferably the material of the stopper (134) is different from the material of the deformable member (152; 352; 452).

[0061] Item 28. The material of the stopper (134) comprises rubber, preferably bromobutyl rubber or ethylene propylene diene monomer (EPDM) rubber, as described in Item 27.

[0062] Item 29. A container as described in any one of items 1 through 28, wherein the deformable member (152; 352; 452) is not in direct contact with the stopper (134).

[0063] Item 30. The locking device (150;350;450;550;650) is in the locked position and meets the following parameters: - The full capacity of the container body (110) is 0.5 to 100 milliliters, preferably 1 to 20 milliliters, and more preferably 1 to 5 milliliters; - The container (700) is pre-filled with liquid (710), preferably 10% to 90%, more preferably 20% to 80%, more preferably 30% to 70%, or more preferably 40% to 60% of the full capacity of the container (700), which is liquid (710) containing sugar or salt; - The container (700) has a headspace of gas (712), preferably air, of 0 to 40 mm, preferably 0.5 to 5 mm, more preferably 1 to 4 mm, and more preferably 1.5 to 3 mm; The conditions are met, The following test conditions, namely: - The external pressure of the container (700) relative to the internal pressure was reduced by 100-1000 millibars, preferably 200-900 millibars, more preferably 300-800 millibars, more preferably 400-600 millibars, and more preferably 430 millibars over a period of 1 second to 1 week, preferably 1 minute to 24 hours, more preferably 1 hour to 6 hours, and more preferably 180 minutes; - The container (700) was stored at -210°C to 25°C, preferably -120°C to 0°C, more preferably -100°C to -15°C, more preferably -90°C to -40°C, and more preferably -80°C for a period of 1 second to 7 days, preferably 1 minute to 24 hours, more preferably 1 hour to 6 hours, and more preferably 180 minutes. The amount of movement of the plunger rod after one or both of the above is applied is 3 millimeters or less, preferably 2 millimeters or less, more preferably 1 millimeter or less, more preferably 0.5 millimeters or less, and more preferably 0 millimeters, according to any one of items 1 to 29. [Brief explanation of the drawing]

[0064] Further details, advantages, and objectives of the present invention will become apparent from the drawings and detailed description. [Figure 1] This is a diagram showing a container as an example. [Figure 2A] Figures 2A and 2B are diagrams that show the locking mechanism of the container shown in Figure 1 in detail in different configurations. [Figure 2B] Figures 2A and 2B are diagrams that show the locking mechanism of the container shown in Figure 1 in detail in different configurations. [Figure 3] This diagram shows a locking device in detail, using another example. [Figure 4] This diagram shows a locking device in detail, using another example. [Figure 5] Figures 5 to 6B are diagrams that show in detail different examples of locking devices in different states. [Figure 6A] Figures 5 to 6B are diagrams that show in detail different examples of locking devices in different states. [Figure 6B]Figures 5 to 6B are diagrams that show in detail different examples of locking devices in different states. [Figure 7] This figure shows a container as another example. [Figure 8] This is a diagram showing sets of different operating components.

[0065] Detailed explanation Figure 1 schematically illustrates a container 100, particularly a syringe. The container 100 comprises a container body 110 and a plunger 130, the plunger 130 partially extending into the container body 110 through an opening 114 provided at the proximal end of the container body 110. The plunger 130 is movable within the container body 110, for example, to dispense the contents of the container body 110 through the tip 116 of the container body 110.

[0066] The plunger 130 includes a plunger rod 132 and a stopper 134 located at the distal end of the plunger rod 132. The stopper 134 defines a variable volume within the container body 110. For this purpose, the stopper 134 extends adjacent to the inner wall 112 of the container body 110. The volume within the container body 110 defined by the stopper 134 is variable depending on the position of the stopper 134 and can be changed by operating it via the plunger rod 132. A thumb rest 138 is provided at the proximal end of the plunger 130. The thumb rest 138 facilitates dispensing the contents through the tip 116 by pushing the plunger 130 inward, particularly during one-handed operation of the container 100. In the illustrated example, the stopper 134 is attached to the plunger rod 132 via a screw thread 136. The threads 136 facilitate the application of tensile force to the stopper 134 when the plunger rod 132 is pulled outward. In another example, a different form of connection between the stopper 134 and the plunger rod 132 is used. In some examples, the stopper 134 is formed integrally with the plunger rod 132.

[0067] With respect to the features and functions described above, container 100 is substantially similar to a conventional syringe, particularly for use with pharmaceuticals and / or medical purposes. Furthermore, in some examples, the container body 110 contains polymer and / or glass.

[0068] The container 100 further has a locking device 150. The locking device 150 is substantially attached to the plunger rod 132 and has a deformable member 152, a sliding member 154 having a distal end 156 and a proximal end 158, a lateral projection 160, and an operating member 170.

[0069] The sliding member 154 is movable parallel to the longitudinally extending portion of the plunger rod 132 and relative to the plunger rod 132. As shown by the arrow parallel to the plunger rod 132 in Figure 1, when the sliding member 154 is moved distally, the distal end 156 of the sliding member 154 applies a pressing force to the deformable member 152. The deformable member 152 also comes into contact with the lateral projection 160 extending from the plunger rod 132. As a result, a compressive force is applied to the deformable member 152.

[0070] As shown in Figure 1, both the distal end 156 and the lateral projection of the sliding member 154 have a wedge-shaped cross-section. Furthermore, as indicated by the bidirectional arrows in Figure 1, the wedge-shaped cross-sections of the distal end 156 and the lateral projection cause displacement and / or deformation of the deformable member 152 toward the inner wall 112 of the container body 110, based on the influence of the longitudinal force applied to the sliding member 154.

[0071] As the deformable member 152 is displaced and / or deformed toward the inner wall 112, the friction between the deformable member 152 and the inner wall 112 is increased. As a result, longitudinal movement of the plunger 130 relative to the container body 110 is prevented.

[0072] Furthermore, as the deformable member 152 displaces and / or deforms toward the inner wall 112, the gap between the plunger 130, particularly the plunger rod 132, and the inner wall 112 of the container body 110 is sealed. As a result, the airtightness of the container body 110 is improved.

[0073] In the illustrated examples, each of the container body 110, sliding member 154, deformable member 152, and lateral projection 160 has a shape that is at least substantially symmetrical in the radial direction. For example, the container body 110 is at least substantially cylindrical in some embodiments. In some further examples, the sliding member 154 is substantially tubular, and the deformable member 152 and lateral projection 160 are at least substantially circular and / or annular. In another example, each of the container body 110, sliding member 154, deformable member 152, and lateral projection 160 has at least substantially a polygonal cross-section in a plane perpendicular to the longitudinal direction of the cylinder 110. The polygonal cross-section of each of these parts corresponds to a polygon with an odd number of corners in some examples.

[0074] The deformable member 152 is substantially ring-shaped. Therefore, when the distal end 156 of the sliding member 154 moves toward the lateral projection 160, the inner diameter of the deformable member 152 is expanded. Consequently, the cross-section of the deformable member 152 is displaced toward the inner wall 112 of the container body 110. Furthermore, the deformable member 152 is pressed against the inner wall 112 of the container body 110, resulting in deformation of the cross-section of the deformable member 152.

[0075] In some examples, the deformable member 152 is manufactured from an elastic material, such as elastic silicone. Furthermore, in some examples, the deformable member 152 has a Shore hardness in the range of 25 to 80 Shore A, preferably in the range of 25 to 50 Shore A, and more preferably in the range of 30 to 35 Shore A.

[0076] Furthermore, in some examples, the material of the stopper 134 and the material of the deformable member 152 are different. In some examples, the material of the stopper 134 includes rubber, preferably bromobutyl rubber. Furthermore, in some examples, the deformable member 152 and the stopper 134 are not in direct contact.

[0077] As described above, when the pressing force acting on the deformable member 152 is removed by moving the sliding member 154 outward, the deformable member 152 returns to its natural state. Therefore, the deformable member 152 is less likely to be displaced toward the inner wall 112 of the container body 110 and less likely to be deformed by the inner wall of the container body 110. As a result, friction between the deformable member 152 and the inner wall 112 is reduced. Therefore, the movement of the plunger 130 relative to the container body 110 is less likely to be blocked by the locking device 150, or is not blocked at all. In this way, by moving the sliding member 154 away from or toward the position where the distal end 156 of the sliding member 154 presses against the deformable member 152, the locking device 150 is changed from the locked position to the unlocked position, and vice versa.

[0078] The locking device 150 further includes an operating member 170. The operating member 170 is movable between an unlocked position and a locked position. Furthermore, the operating member 170 is configured to hold the sliding member 154 in a position corresponding to the locked position of the locking device 150 when the operating member 170 is in the locked position, and to release the sliding member 154 from the position corresponding to the locked position of the locking device 150 when the operating member 170 is moved from the locked position to the unlocked position.

[0079] In some examples, the actuarial member 170 is further configured to move the sliding member 154 from a position corresponding to the unlocked position of the locking device 150 to a position corresponding to the locked position of the locking device 150 when the actuarial member 170 is moved from its unlocked position to its locked position.

[0080] In the example shown in Figure 1, the actuator 170 is positioned between the thumb rest 138 and the proximal end 158 of the sliding member 154. Furthermore, in the illustrated example, the actuator 170 is formed separately from the plunger 130 and the sliding member 154. In some examples, the actuator 170 is formed as a separate part that can be removed from the plunger 130. In another example, the actuator 170 is movably attached to the plunger 130.

[0081] In some cases, the actuarial member 170 further serves as evidence of sealing and / or fraud of the container 100. For this purpose, the actuarial member 170 is attached to the plunger 130 in a position corresponding to the locked position of the locking device 150, for example in the form of a spacer, and is irreversibly removable from the plunger 130.

[0082] Figure 1 shows the locking device 150 in the unlocked position. As can be seen from Figure 1, by moving the sliding member 154 inward to the locked position of the locking device 150, it becomes possible to insert the actuator 170 between the thumb rest 138 and the proximal end 158 of the sliding member 154. Once inserted, the actuator 170 will hold the locking device 150 in the locked position in a releaseable manner.

[0083] The actuating member 170 has a wedge portion 172 facing the proximal end 158 of the sliding member 154. When the actuating member 170 is moved to a position between the thumb rest 138 and the sliding member 154, as shown by the arrow next to the actuating member 170 in Figure 1, the sliding member 154 is moved inward, and as a result, the locking device 150 is brought into the locked position. In this way, the wedge portion 172 facilitates the operation of the locking system 150.

[0084] Figures 2A and 2B show details of the locking device 150 in the unlocked and locked positions. The same reference numerals as those shown in Figure 1 indicate the same features. As shown in Figure 2A, the distal end 156 of the sliding member 154 is angled by a predetermined angle W1 with respect to the orthogonal plane. Furthermore, the surface of the lateral projection 160 is angled by an angle W2 with respect to the orthogonal plane. The angles W1 and W2 determine the degree of displacement of the deformable member 152 with respect to the length by which the sliding member 154 is moved toward the lateral projection 160. Generally, the larger the selected angles W1 and W2, the smaller the operating force required to be applied to the sliding member 154, but the greater the length required for the sliding member 154 to move when the locking device 150 is activated.

[0085] Furthermore, the cross-section of the deformable member 152 has a apex at an angle W3 on its outer surface. The cross-section with the apex generates an increased local locking force in the apex region when the locking device 150 is in the locked position. This increases local friction and improves sealing by the deformable member. At the same time, the contact length between the deformable member 152 and the inner wall 112 of the container body 110 is effectively reduced when the locking device 150 is in the unlocked position. Moreover, the angle W3 defines the deformation of the deformable member 152 when it is pressed against the inner wall 112 in the locked position of the locking device 150. The larger the selected angle W3, the greater the contact length between the deformable member 152 and the inner wall 112 of the container body 110 when the locking device 150 is in the locked position. Furthermore, the uniformity of the contact pressure over the contact length between the deformable member 152 and the inner wall 112 can be adjusted by selecting the angle W3.

[0086] Figure 2B shows the locking device 150 in the locked position. As described above with respect to Figure 2A, the outer surface of the deformable member 152 is pressed against the inner wall 112 of the container body 110, causing deformation of the cross-section of the deformable member 152. In particular, the outer surface of the deformable member 152 having its apex in the relaxed state is deformed in such a way that it creates a contact length L_C with the inner wall 112 that extends substantially along the entire length of the deformable member 152.

[0087] In some examples, the container body 110 is uncoated or silicone-free coated in the area that comes into contact with the deformable member 152 when the locking device 150 is in the locked position. In some further examples, the material of the deformable member 152 contains silicone, and / or the deformable member 152 is silicone oil-free coated, preferably liquid-free coated, or more preferably uncoated.

[0088] Furthermore, in some examples, the container body 110 is transparent in the area that contacts the deformable member 152 when the locking device 150 is in the locked position. In addition, the surface of the deformable member 152 has one or more properties, such as surface roughness, that change when the surface of the deformable member 152 is pressed against the inner wall 112 of the container body 110, thereby changing the visual appearance of the deformable member 152 when viewed from the outside of the container body 110 through the inner wall 112, for example, the brightness of a grayscale image. This facilitates the user's inspection of the locked state of the locking device 150.

[0089] Figure 3 schematically illustrates the details of the locking device 350 in another example. The same reference numerals as those shown in Figures 1 to 2B indicate the same features. Furthermore, the features and functions of the locking device 150 described above also apply to the locking device 350 unless otherwise specified below.

[0090] In the locking device 350, the lateral projection 360 and the distal end 356 of the sliding member 354 are not angled, but are formed parallel to the orthogonal plane. As a result, the displacement of the cross-section of the deformable member 352 toward the inner wall 112 is not directly caused by moving the sliding member 354 toward the lateral projection 360 attached to the plunger rod 332 adjacent to the thread 136. Instead, compression of the cross-section of the deformable member 352 occurs between the parallel planes of the distal end 356 and the lateral projection 360. This also leads to deformation of the cross-section of the deformable member 352, causing at least a portion of the outer side of the deformable member 352 to move toward the inner wall 112 as indicated by the bidirectional arrows.

[0091] Figure 4 schematically illustrates the details of locking device 450 in another example. The same reference numerals as those shown in Figures 1 to 3 indicate the same features. Furthermore, the features and functions of locking devices 150 and 350 described above also apply to locking device 450 unless otherwise specified in Figure 4 and the following description.

[0092] In the locking device 450, the distal end 156 of the sliding member 154 is angled, whereas the lateral projection 460 extending from the plunger rod 432 adjacent to the screw thread 136 is not angled. Furthermore, the cross-section of the deformable member 452 is substantially circular.

[0093] When the sliding member 154 is moved toward the lateral projection 460, the angled distal end 156 causes a displacement of the cross-section of the deformable member 452 toward the inner wall 112 of the container body 110, as indicated by the arrow next to the deformable member 452. At the same time, the circular shape of the cross-section of the deformable member 452 facilitates the sliding of the deformable member 452 along the lateral projection 460.

[0094] In each of the above examples, the lateral projections of each locking device are formed separately from the stopper 134. However, in another example of the locking device described, the lateral projections are formed integrally with the stopper 134, particularly at the proximal end of the stopper 134. In these examples, the rigid mounting portion of the stopper 134 to the plunger rod, for example via threads, is provided to support the pressing force applied to the deformable member when the locking device is in the locked position.

[0095] Figure 5 schematically illustrates details of the locking device 550 in another example, in both the unlocked state (top of Figure 5) and the locked state (bottom of Figure 5). The features and functions of the locking devices 150, 350, and 450 described above also apply to the locking device 550 unless otherwise specified in Figure 5 and the following description.

[0096] In the locking device 550, at least one actuating member 570 has a pair of wedge portions 558, 572 that engage with each other, one of which is formed integrally with the sliding member 554 so as to constitute the proximal end 558 of the sliding member 554, and the other is formed on the lower surface of the thumb rest 538 of the plunger 530.

[0097] As shown by the curved arrow at the top of Figure 5, the sliding member 554 can be rotated relative to the plunger rod 532 about its longitudinal axis. In this way, the relative positions of the wedge portions 558 and 572 are changed, resulting in a movement of the sliding member 554 parallel to its longitudinal axis, that is, toward or away from the lateral projection (not shown) of the locking device 550.

[0098] As shown in the lower part of Figure 5, the locked position of the locking device 550 corresponds in some examples to the symmetrical position of the wedge portions 558 and 572. In this position, no torque is generated on the sliding member 554 as a result of a reaction force applied to the sliding member 554 by a deformable member (not shown). Furthermore, in some examples, the surface friction between the wedge portions 558 and 572 is sufficient to hold the locking device 550 in the locked position.

[0099] In the illustrated example, the sliding member 554 is rotatable relative to the plunger rod 532 and the thumb rest 538. In another example, the wedge portion 572 is rotatable relative to the sliding member 554 and the plunger rod 532, together with the thumb rest 538 in some examples.

[0100] In one variation of the locking device 550, the actuator 570 has a pair of threads that engage instead of the wedge portions 558, 572. In one example, one thread is located on the distal portion of the sliding member 554, and the corresponding thread that engages with the thread of the sliding member 554 is located on the underside of the thumb rest 538, or as a separate part between the thumb rest 538 and the sliding member 554, for example, as a tubular spacer. For example, by rotating the sliding member 554 and the tubular spacer or thumb rest 538 respectively, the engaging threads rotate relative to each other, which changes the distance the sliding member 554 moves in the direction of the deformable member. In some examples, the actuator 570 having a pair of engaging threads can also be used to adjust the locking force applied by the locking device 550 by corresponding rotation of the threads.

[0101] Figure 6A schematically illustrates details of the locking device 650 in another example, in the locked state (i), the released state (ii), and the unlocked state (iii). The features and functions of the locking devices 150, 350, and 450 described above also apply to the locking device 650 unless otherwise specified in Figure 6 and the following description.

[0102] In the locking device 650, at least one actuating member 670 has at least one elastic finger 672, the elastic finger 672 extending from the lower surface of the thumb rest 638 of the plunger 630 and engaging with the contour 658 at the proximal end of the sliding member 654.

[0103] As shown in the upper part (i) of Figure 6A, when the locking device is in the locked position, the elastic finger 672 prevents the contour 658 from moving outward. In this way, the locking device 650 is held in the locked position.

[0104] As shown in the middle section (ii) of Figure 6A, when the user pulls the sliding member 654 outward with manual force, the elastic finger 672 bends, thereby releasing the sliding member 654 from its restricted state.

[0105] As shown in the lower part (iii) of Figure 6A, when the sliding member 654 is moved to a position corresponding to the unlocked position of the locking device 650, the elastic finger 672 engages with the contour 658, thereby holding the sliding member 654 in the outward position. In this way, the locking device 650 is kept in the unlocked state.

[0106] Figure 6B shows further details of the locking device 650. In some examples, a toothed contour is provided on the underside of the thumb rest 638, as shown in Figure 6B. In combination with the toothed contour on the elastic finger 672, the unlocking of the locking device 650 can be made irreversible.

[0107] In some cases, instead of pulling the sliding member 654 outward, the user can unlock the locking device 650 simply by pushing the thumb rest 638 inward. As is evident from the middle section (ii) of Figure 6A, when the user pushes the thumb rest 638 inward, the plunger 630 can be moved slightly inward, except for the sliding member 654 which is held in place by the deformable member. This small movement of the plunger 630 relative to the sliding member 654 is made possible by the elastic properties of the elastic finger 672. Furthermore, the deformation of the elastic finger 672 due to the small movement of the plunger 630 also leads to the release of the contour 658 by the elastic finger 672. This operation facilitates one-handed use of the container and the locking device 650. In particular, even if the user is unaware of the locking device 650 and its operating modes, the injection can be successfully used, for example, in an emergency. This is because the user does not need to perform any actions different from those used with conventional syringes; they simply need to apply increasing pressure to overcome the resistance provided by the elastic finger 672.

[0108] Figure 7 schematically illustrates another example of container 700. The same reference numerals as those shown in Figure 1 indicate the same features. Furthermore, the above description of Figure 1 applies correspondingly to the container 700 shown in Figure 7. The locking device 150 of container 700 is in the locked position.

[0109] The container 700 is pre-filled with liquid 710. Furthermore, the headspace of the container 700 contains gas 712, such as air.

[0110] With respect to the movement of the plunger 130, the resultant force acting on the plunger 130 due to the thermal expansion and / or contraction of the contents of the container 700 depends, among many other conditions, particularly on the type and amount of substances 710 and 712 contained in the container 700.

[0111] In some examples, the deformable member of the locking device 150 is configured to seal the gap between the inner wall of the container body 110 and the plunger 130 against a pressure difference of at least 500 millibars, preferably at least 600 millibars, and more preferably at least 800 millibars, at a temperature of -80°C.

[0112] Furthermore, in some examples, the locking device 150 is configured to reduce the movement of the plunger 130 relative to the container body 110 to less than 3 millimeters, preferably less than 2 millimeters, more preferably less than 1.5 millimeters, and more preferably less than 0.5 millimeters when a pressure difference of 500 millibars, preferably 600 millibars, and more preferably less than 800 millibars is applied at a temperature of -20°C, preferably -50°C, and more preferably -80°C.

[0113] In some examples of container 700, the following parameters are simultaneously met: The full capacity of the container body 110 is 0.5 to 100 milliliters, preferably 1 to 20 milliliters, and more preferably 1 to 5 milliliters. Furthermore, container 700 is pre-filled with liquid 710 to 10% to 90%, more preferably 20% to 80%, more preferably 30% to 70%, and more preferably 40% to 60% of the full capacity of container 700. Preferably, liquid 710 contains sugar or salt. Furthermore, container 700 has a headspace of gas 712, preferably air, of 0 to 10 millimeters, preferably 0.5 to 5 millimeters, more preferably 1 to 4 millimeters, and more preferably 1.5 to 3 millimeters. Furthermore, the amount of movement of the plunger rod after one or both of the following test conditions are applied is 3 millimeters or less, preferably 2 millimeters or less, more preferably 1 millimeter or less, more preferably 0.5 mm or less, and more preferably 0 mm.

[0114] Test condition 1: The external pressure of container 700 was reduced relative to the internal pressure by 100-1000 millibars, preferably 200-900 millibars, more preferably 300-800 millibars, more preferably 400-600 millibars, and more preferably 430 millibars for a period of 1 second to 1 week, preferably 1 minute to 24 hours, more preferably 1 hour to 6 hours, and more preferably 180 minutes.

[0115] Test condition 2: Container 700 was stored at -150°C to 25°C, preferably -120°C to 0°C, more preferably -100°C to -15°C, more preferably -90°C to -40°C, and more preferably -80°C for a period of 1 second to 7 days, preferably 1 minute to 24 hours, more preferably 1 hour to 6 hours, and more preferably 180 minutes.

[0116] Figure 8 shows a set of actuarial members 870a to 870d. The actuarial members 870a to 870d can be interchangeably used, for example, as actuarial members 170 in the form of pins, in relation to the locking device 150 shown in Figures 1 and 7. As can be seen in Figure 8, the actuarial members 870a to 870d differ from each other in terms of the thickness of their wedge-shaped cross-sections. Therefore, by selecting any one of the actuarial members 870a to 870d, the resulting locking force of the locking device can be adjusted. In one example, the total release / sliding force of the plunger as a part of the described type of container is adjusted by correspondingly selecting one of the actuarial members 870a to 870d.

[0117] As described above, each example of a locking device has been explained in relation to a syringe. However, as can be seen, some or all of the features and functions of the locking devices described may be implemented accordingly in relation to other types of containers, such as cartridges.

Claims

1. A container (100; 700), in particular a syringe or cartridge, A container body (110), a plunger (130; 530; 630) having a plunger rod (132; 332; 432; 532; 632) disposed at least partially within said container body (110); a locking device (150; 350; 450; 550; 650) for locking the position of the plunger rod (132; 332; 432; 532; 632) relative to the container body (110); In a container (100; 700) having The locking device (150; 350; 450; 550; 650) is operable between at least a locked position and an unlocked position, and the locking device (150; 350; 450; 550; 650) has at least one deformable member (152; 352; 452) that deforms the plunger rod (132; 352) when the locking device (150; 350; 450; 550; 650) is in the locked position. 32; 432; 532; 632) and an inner wall (112) of the container body (110), and when the locking device (150; 350; 450; 550; 650) is switched from the locked position to the unlocked position, the locking force between the plunger rod (132; 332; 432; 532; 632) and the inner wall (112) of the container body (110) is released.

2. 2. The container of claim 1, wherein the locking device (150; 350; 450; 550; 650) is attached to the plunger rod (132; 332; 432; 532; 632).

3. The deformable member (152; 352; 452) is arranged to extend along the inner circumference of the container body (110), and preferably the inner periphery of the container body (110) is substantially circular and the deformable member (152; 352; 452) has a substantially circular shape; or the inner periphery of the container body (110) is substantially polygonal, and the deformable member (152; 352; 452) has a substantially polygonal shape; 3. The container according to claim 1 or 2.

4. 3. The container according to claim 1 or 2, wherein the deformable member (152; 352; 452) is further configured to seal a gap between the inner wall of the container body (110) and the plunger rod (132; 332; 432; 532; 632) when the locking device (150; 350; 450; 550; 650) is in the locked position.

5. 3. A container according to claim 1 or 2, wherein the locking device (150; 350; 450; 550; 650) further comprises a lateral protrusion (160; 360; 460) extending from a portion of the plunger rod (132; 332; 432; 532; 632), and wherein the deformable member (152; 352; 452) is arranged to be pressed towards the lateral protrusion (160; 360; 460) when the locking device (150; 350; 450; 550; 650) is in the locked position.

6. 6. The container of claim 5, wherein the locking device (150; 350; 450; 550; 650) further comprises a sliding member (154; 354; 554; 654) movable relative to the plunger rod (132; 332; 432; 532; 632) and configured to apply a pressing force to the deformable member (152; 352; 452) toward the lateral protrusion (160; 360; 460) when the locking device (150; 350; 450; 550; 650) is in the locked position.

7. 7. The container according to claim 6, wherein the lateral protrusion (160; 360; 460) and / or the sliding member (154; 354; 554; 654) are configured to cause deformation and / or displacement of at least a portion of the deformable member (152; 352; 452) towards the inner wall (112) of the container body (110) when the locking device (150; 350; 450; 550; 650) is in the locked position.

8. said lateral protrusion (160; 360; 460) extending from said plunger rod (132; 332; 432; 532; 632), said sliding member (154; 354; 554; 654) having a tube inside which said plunger rod (132; 332; 432; 532; 632) extends at least partially; and / or the locking device (150; 350; 450; 550; 650) further comprises at least one actuating member (170; 570; 670) configured to move the sliding member (154; 354; 554; 654) towards the deformable member (152; 352; 452) when bringing the locking device (150; 350; 450; 550; 650) into the locked position and / or to releasably hold the locking device (150; 350; 450; 550; 650) in the locked position, The container of claim 6.

9. the container body (110) is uncoated or has a silicone-free coating in the area that contacts the deformable member (152; 352; 452) when the locking device (150; 350; 450; 550; 650) is in the locked position, and / or the material of said deformable element (152; 352; 452) comprises silicone and / or said deformable element (152; 352; 452) is silicone oil-free coated, preferably liquid-free coated, or more preferably uncoated, 3. The container according to claim 1 or 2.

10. 3. The container (100; 700) according to claim 1 or 2, wherein the container (100; 700) is a pharmaceutical container, in particular a syringe or a cartridge, and / or the container (700) is pre-filled.

11. The deformable member (152; 352; 452) is further configured to seal a gap between the inner wall of the container body (110) and the plunger rod (132; 332; 432; 532; 632) when the locking device (150; 350; 450; 550; 650) is in the locked position; 3. The container according to claim 1 or 2, wherein the deformable member (152; 352; 452) is configured to seal the gap between the inner wall of the container body (110) and the plunger rod (132; 332; 432; 532; 632) against a pressure difference of at least 500 mbar, preferably at least 600 mbar, more preferably at least 800 mbar, at a temperature of -80°C.

12. 3. The container according to claim 1 or 2, wherein the locking device (150) is configured to reduce the movement of the plunger (130) relative to the container body (110) to less than 3 millimeters, preferably less than 2 millimeters, more preferably less than 1.5 millimeters, more preferably less than 0.5 millimeters when subjected to a pressure differential of 500 millibars, preferably 600 millibars, more preferably 800 millibars at a temperature of -20°C, preferably -50°C, more preferably -80°C.

13. Container according to claim 1 or 2, wherein the locking device (150; 350; 450; 550; 650) is configured to apply a locking force in the range of 5 to 15 Newtons.

14. 3. The container according to claim 1, wherein when the locking device (150; 350; 450; 550; 650) is in the unlocked position, a contact length (L_C) between the deformable member (152; 352; 452) and the inner wall (112) of the container body (110) is in a range of 0 to 1 millimeter, preferably 0 millimeter; and / or when the locking device (150; 350; 450; 550; 650) is in the locked position, a contact length (L_C) between the deformable member (152; 352; 452) and the inner wall (112) of the container body (110) is in a range of 2 to 20 millimeters, preferably 3 to 4 millimeters.

15. 3. A container according to claim 1 or 2, wherein the deformable member (152; 352; 452) is not in direct contact with the stopper (134).

16. The locking device (150; 350; 450; 550; 650) is in the locked position and has the following parameters: - the full capacity of the container body (110) is between 0.5 and 100 milliliters, preferably between 1 and 20 milliliters, more preferably between 1 and 5 milliliters; - said container (700) is pre-filled with a liquid (710), more preferably a liquid (710) containing sugar or salt, preferably 10% to 90%, more preferably 20% to 80%, more preferably 30% to 70%, more preferably 40% to 60% of the full capacity of said container (700); - said container (700) has a headspace of gas (712), preferably air, of 0 to 40 mm, preferably 0.5 to 5 mm, more preferably 1 to 4 mm, more preferably 1.5 to 3 mm; is satisfied, The following test conditions were used: - the pressure outside said container (700) relative to the inside has been reduced by 100-1000 mbar, preferably 200-900 mbar, more preferably 300-800 mbar, more preferably 400-600 mbar, more preferably 430 mbar, in a time of 1 second to 1 week, preferably 1 minute to 24 hours, more preferably 1 hour to 6 hours, more preferably 180 minutes; - said container (700) has been stored at -210°C to 25°C, preferably -120°C to 0°C, more preferably -100°C to -15°C, more preferably -90°C to -40°C, more preferably -80°C for 1 second to 7 days, preferably 1 minute to 24 hours, more preferably 1 hour to 6 hours, more preferably 180 minutes; The amount of movement of the plunger rod after one or both of the above is applied is 3 millimeters or less, preferably 2 millimeters or less, more preferably 1 millimeter or less, more preferably 0.5 millimeters or less, and more preferably 0 millimeters.

3. The container according to claim 1 or 2.

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