CONTAINER WITH PLUNGER AND LOCKING ARRANGEMENT
20230347063 · 2023-11-02
Assignee
Inventors
Cpc classification
A61M2005/5033
HUMAN NECESSITIES
A61M5/31501
HUMAN NECESSITIES
International classification
Abstract
A syringe includes: a container body including an inner wall; a plunger including a plunger rod, the plunger rod being disposed at least partially within the container body; and a locking arrangement configured for locking a position of the plunger rod relative to the container body and for being operable between at least a locked position and an unlocked position, the locking arrangement including at least one deformable element which is configured for applying a locking force between the plunger rod and the inner wall of the container body when the locking arrangement is in the locked position and for releasing the locking force between the plunger rod and the inner wall of the container body when the locking arrangement is changed from the locked position to the unlocked position.
Claims
1. A syringe, comprising: a container body including an inner wall; a plunger including a plunger rod, the plunger rod being disposed at least partially within the container body; and a locking arrangement configured for locking a position of the plunger rod relative to the container body and for being operable between at least a locked position and an unlocked position, the locking arrangement including at least one deformable element which is configured for applying a locking force between the plunger rod and the inner wall of the container body when the locking arrangement is in the locked position and for releasing the locking force between the plunger rod and the inner wall of the container body when the locking arrangement is changed from the locked position to the unlocked position.
2. The syringe according to claim 1, wherein the locking arrangement is attached to the plunger rod.
3. The syringe according to claim 1, wherein the container body includes an inner periphery, the at least one deformable element being arranged to extend along the inner periphery of the container body.
4. The syringe according to claim 3, wherein (i) the inner periphery of the container body is essentially circular, and the at least one deformable element has an essentially circular shape, or (ii) the inner periphery of the container body is essentially polygonal, and the at least one deformable element has an essentially polygonal shape.
5. The syringe according to claim 1, wherein the at least one deformable element is further configured to seal a gap between the inner wall of the container body and the plunger rod when the locking arrangement is in the locked position.
6. The syringe according to claim 5, wherein the at least one deformable element is 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, at a temperature of minus 80 degrees Celsius.
7. The syringe according to claim 6, wherein the pressure difference is at least 600 Millibars or at least 800 Millibars.
8. The syringe according to claim 1, wherein the locking arrangement further comprises a lateral protuberance which extends from a portion of the plunger rod, and wherein the at least one deformable element is arranged to be pressed towards the lateral protuberance when the locking arrangement is in the locked position.
9. The syringe according to claim 8, wherein the locking arrangement further comprises a sliding member which is configured for moving relative to the plunger rod and is configured to apply a pressing force on the at least one deformable element towards the lateral protuberance when the locking arrangement is in the locked position.
10. The syringe according to claim 9, wherein at least one of the lateral protuberance and the sliding member are configured to cause at least one of deformation and displacement of at least a portion of the at least one deformable element towards the inner wall of the container body when the locking arrangement is in the locked position.
11. The syringe according to claim 9, wherein at least one of: the lateral protuberance extends from the plunger rod, and the sliding member comprises a tube in which the plunger rod extends at least partially; and the locking arrangement further comprises at least one actuating member configured for at least one of (a) moving the sliding member towards the at least one deformable element when bringing the locking arrangement to the locked position, and (b) for releasably holding the locking arrangement in the locked position.
12. The syringe according to claim 1, wherein at least one of: (a) the container body is uncoated or silicone-free coated in an area of the container body contacting with the at least one deformable element when the locking arrangement is in the locked position; and (b) at least one of (i) a material of the at least one deformable element comprises a silicone, and (ii) the at least one deformable element is silicone oil-free coated.
13. The syringe according to claim 12, wherein the at least one deformable element is silicone oil-free coated, liquid-free coated, or uncoated.
14. The syringe according to claim 1, wherein the container is pre-filled.
15. The syringe according to claim 1, wherein the locking arrangement is configured to reduce a motion of the plunger relative to the container body to less than 3 millimeters, when applying a pressure difference of 500 Millibars, at a temperature of minus 20 degrees Celsius.
16. The syringe according to claim 1, wherein the locking arrangement is configured to apply the locking force in a range of 5 to 15 newtons.
17. The syringe according to claim 1, wherein at least one of: (a) a contact length between the at least one deformable element and the inner wall of the container body is in a range of 0 to 1 millimeters, when the locking arrangement is in the unlocked position; and (b) a contact length between the at least one deformable element and the inner wall of the container body is in a range of 2 to 20 millimeters, when the locking arrangement is in the locked position.
18. The syringe according to claim 1, further comprising a stopper, wherein the at least one deformable element is not in direct contact with the stopper.
19. The syringe according to claim 1, wherein the locking arrangement is in the locked position and the following parameters are fulfilled: a brimful volume of the container body is 0.5 to 100 milliliters; the container is configured for being prefilled with a liquid; the container further comprises a headspace of gas of 0 to 40 millimeters; wherein a movement of the plunger rod is 3 millimeters or less, after at least one of the following test conditions has been applied: (i) a pressure outside the container with regard to an inside of the container is reduced by 100 to 1000 millibars, for 1 second to 1 week; (ii) the container is stored at −210° C. to 25° C., for 1 second to 7 days.
20. The syringe according to claim 19, wherein the locking arrangement is in the locked position and the following parameters are fulfilled: the brimful volume of the container body is 1 to 20 milliliters or 1 to 5 milliliters; the container is configured for being prefilled with the liquid, with 10% to 90%, 20% to 80%, 30% to 70%, or 40% to 60% of the brimful volume of the container, wherein the liquid comprises a sugar or a salt; the container further comprises the headspace of air of 0 to 40 millimeters, 0.5 to 5 millimeters, 1 to 4 millimeters, or 1.5 to 3 millimeters; wherein a movement of the plunger rod is 2 millimeters or less, 1 millimeter or less, 0.5 millimeters or less, or 0 millimeters, after at least one of the following test conditions has been applied: (i) the pressure outside the container with regard to the inside of the container is reduced by 200 to 900 millibars, 300 to 800 millibars, 400 to 600 millibars, or 430 millibars for 1 second to 1 week, 1 minute to 24 hours, 1 hour to 6 hours, or 180 minutes; (ii) the container is stored at −120° C. to 0° C., −100° C. to −15° C., −90° C. to −40° C., or −80° C., for 1 second to 7 days, 1 minute to 24 hours, 1 hour to 6 hours, or 180 minutes.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0075] The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:
[0076]
[0077]
[0078]
[0079]
[0080]
[0081]
[0082] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate embodiments of the invention, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.
DETAILED DESCRIPTION OF THE INVENTION
[0083]
[0084] The plunger 130 includes a plunger rod 132 and a stopper 134 which is arranged at a distal end of the plunger rod 13. The stopper 134 delimits a variable volume inside the container 110. To this end, the stopper 134 extends adjacent an inner wall 112 of the container 110. The volume in the container 110 which is delimited by the stopper 134 is variable according to a position of the stopper 134, which can be modified through manipulation by way of the plunger rod 132. A thumb rest 138 is provided at a proximal end of the plunger 130. The thumb rest 138 facilitates a delivering of content through the tip 116 by pushing the plunger 130 in an inward direction, especially in a single-handed operation of the container 100. In the shown example, the stopper 134 is attached to the plunger rod 132 by way of a thread 136. The thread 136 facilitates the application of a pulling force on the stopper 134 when pulling the plunger rod 132 in an outward direction. In other examples, other types of connections between the stopper 134 and the plunger rod 132 are used. In some examples, the stopper 134 is formed integrally with the plunger rod 132.
[0085] With respect to the aforesaid features and functions, the container 100 essentially resembles a conventional syringe, in particular for pharmaceutical and/or medical use. Furthermore, in some examples the container body 110 includes polymer and/or glass.
[0086] The container 100 further includes a locking arrangement 150. The locking arrangement 150 is essentially attached to the plunger rod 132 and includes a deformable element 152, a sliding member 154 having a distal end 156 and a proximal end 158, a lateral protrusion 160 and an actuating member 170.
[0087] The sliding member 154 is movable relative to the plunger rod 132 parallel to a longitudinal extension of the plunger rod 132. Moving the sliding member 154 in the distal direction, as indicated in
[0088] As shown in
[0089] By displacing and/or deforming the deformable element 152 towards the inner wall 112, a friction between the deformable element 152 and the inner wall 112 is increased. As a result, motion of the plunger 130 relative to the container body 110 in a longitudinal direction is inhibited.
[0090] Furthermore, by displacing and/or deforming the deformable element 152 towards the inner wall 112, a gap between the plunger 130, in particular the plunger rod 132, and the inner wall 112 of the container body 110 becomes sealed. As an effect, a tightness of the container 110 is increased.
[0091] In the shown example, each of the container body 110, the sliding member 154, the deformable element 152 and the lateral protrusion 160 has, at least essentially, a radially symmetric shape. For example, the container body 110 is in some implementations at least essentially cylindrical. Moreover, in some examples, the sliding member 154 is essentially tube-shaped, and the deformable element 152 and the lateral protrusion 160 are at least essentially circular and/or ring-shaped. In other examples, each of the container body 110, the sliding member 154, the deformable element 152 and the lateral protrusion 160 has, at least essentially, a polygonal cross-section in a plane that is orthogonal to a longitudinal direction of the cylinder 110. A polygonal cross-section of each of these parts corresponds in some examples to a polygon having an odd number of corners.
[0092] The deformable element 152 is essentially ring-shaped. Thus, when the distal end 156 of the sliding member 154 moves towards the lateral protrusion 160, an inner diameter of the deformable element 152 becomes expanded. Accordingly, a profile of the deformable element 152 becomes displaced towards the inner wall 112 of the container 110. Furthermore, the deformable element 152 will be pressed against the inner wall 112 of the container 110, resulting in a deformation of the profile of the deformable element 152.
[0093] The deformable element 152 is in some examples made of elastic material, such as an elastic silicone. In addition, in some examples the deformable element 152 has a Shore hardness in the range from 25 to 80 Shores A, optionally in the range from 25 to 50 Shores A, optionally in the range from 30 to 35 Shores A.
[0094] In addition, in some examples a material of the stopper 134 and the material of the deformable element 152 are different. The material of the stopper 134 includes in some examples a rubber, optionally a brombutyl rubber. Furthermore, in some examples the deformable element 152 and the stopper 134 are not in direct contact.
[0095] When a pressing force acting on the deformable element 152, as described above, is released, by moving the sliding member 154 outwardly, the deformable element 152 will return towards its natural state. Accordingly, the deformable element 152 will adopt a state in which it is less displaced towards, and less deformed by, the inner wall 112 of the container body 110. As a consequence, a friction between the deformable element 152 and the inner wall 112 is reduced. A motion of the plunger 130 relative to the container body 110 thus becomes less or not inhibited by the locking arrangement 150. In this manner, the locking arrangement 150 is changed from a locked position to an unlocked position, and vice versa, by moving the sliding member 154 away from, or towards, a position in which the distal end 156 of the sliding member 154 presses on the deformable element 152.
[0096] The locking arrangement 150 further includes an actuating member 170. The actuating member 170 is movable between an unlocked and a locked position. Furthermore, the actuating member 170 is configured to hold the sliding member 154 in a position corresponding to the locked position of the locking arrangement 150, when the actuating member 170 is in its locked position, and to release the sliding member 154 from the position corresponding to the locked position of the locking arrangement 150, when the actuating member 170 is moved from its locked position to its unlocked position.
[0097] In some examples, the actuating member 170 is further configured to move the sliding member 154 from a position corresponding to an unlocked position of the locking arrangement 150 to a position corresponding to the locked position of the locking arrangement 150, when the actuating member 170 is moved from its unlocked position to its locked position.
[0098] In the example shown in
[0099] In some examples, the actuating member 170 further serves as a seal and/or a tampering evidence of the container 100. For this purpose, the actuating member 170, for example, in the form of a spacer, is attached to the plunger 130 in a position corresponding to a locked position of the locking arrangement 150 and is irreversibly removable from the plunger 130.
[0100]
[0101] The actuating member 170 includes a wedge 172, which is facing the proximal end 158 of the sliding member 154. By way of the wedge 172, when the actuating member 170 is moved into a position between the thumb rest 138 and the sliding member 154, as indicated by the arrow next to the actuating member 170 in
[0102]
[0103] Furthermore, the profile of the deformable element 152 is peaked at an outer surface of the deformable element 152 by the angle W3. A peaked profile causes an increased local locking force in the region of the peak, when the locking arrangement 150 is in the locked position. This gives rise to an increased local friction and improved sealing by the deformable element. At the same time, a contact length between the deformable element 152 and the inner wall 112 of the container 110 when the locking arrangement 150 is in the unlocked position is effectively reduced. Furthermore, the angle W3 determines a deformation of the deformable element 152 when the latter is pressed against the inner wall 112 in the locked position of the locking arrangement 112. The larger the angle W3 is chosen, the larger will be a contact length of the deformable element 112 with the inner wall 112 of the container 110 when the locking arrangement 150 is in the locked position. Moreover, a homogeneity of the contact pressure over the contact length between the deformable element 152 and the inner wall 112 can be adjusted by the choice of the angle W3.
[0104]
[0105] In some examples, the container body 110 is uncoated or silicone-free coated in the area which is in contact with the deformable element 152 when the locking arrangement 150 is in the locked position. In addition, in some examples a material of the deformable element 152 includes a silicone and/or the deformable element 152 is silicone oil-free coated, optionally liquid-free coated, or, optionally, is uncoated.
[0106] Furthermore, in some examples, the container body 110 is transparent in the area which is in contact with the deformable element 152 when the locking arrangement 150 is in the locked position. In addition, a surface of the deformable element 152 has one or more characteristics, such as a surface roughness, which alter when the surface of the deformable element 152 is pressed against the inner wall 112 of the container body 110 in such way that an optical appearance of the deformable element 152 as seen from an outside of the container body 110 through the inner wall 112, for example a brightness in a greyscale image, changes. This facilitates an inspection of the locking state of the locking arrangement 150 by a user.
[0107]
[0108] In the locking arrangement 350, the lateral protrusion 360 and the distal end 356 of the sliding member 354 are not angled, but they are formed parallel to an orthogonal plane. As an effect, no displacement of the profile of the deformable element 352 towards the inner wall 112 will be caused directly by moving the sliding member 354 towards the lateral protrusion 360, which is attached to the plunger rod 332 adjacent the thread 136. Instead, compression of the profile of the deformable element 352 will occur between the parallel surfaces of the distal end 356 and the lateral protrusion 360. This in turn will lead to a deformation of the profile of the deformable element 352 such that at least an outer portion of the deformable element 352 will be moved towards the inner wall 112, as indicated by the double arrows.
[0109]
[0110] In the locking arrangement 450, the distal end 156 of the sliding member 154 is angled, whereas the lateral protrusion 460, which extends from the plunger rod 432 adjacent the thread 136, is not angled. Furthermore, a profile of the deformable element 452 is essentially circular.
[0111] When the sliding member 154 is moved towards the lateral protrusion 460, the angled distal end 156 will cause a displacement of the profile of the deformable element 452 towards the inner wall 112 of the container 110, as indicated by the arrow next to the deformable element 452. At the same time, the circular shape of the profile of the deformable element 452 facilitates a sliding of the deformable element 452 along the lateral protrusion 460.
[0112] In the above examples, a lateral protrusion of each of the locking arrangements is formed separate from the stopper 134. However, in other examples of the described locking arrangements, the lateral protrusion is formed integrally with the stopper 134, especially at a proximal end of the stopper 134. In these examples, firm mounting of the stopper 134 to the plunger rod, for example, by way of a thread, is provided to support a pushing force which is applied to the deformable element when the locking arrangement is in the locked position.
[0113]
[0114] In the locking arrangement 550, the at least one actuating member 570 includes a pair of mutually engaging wedges 558, 572, one of which is integrally formed with the sliding member 554 to constitute a proximal end 558 of the sliding member 554, and the other one is formed at an underside of the thumb rest 538 of the plunger 530.
[0115] As indicated in the upper portion of
[0116] As shown in the lower portion of
[0117] In the shown example, the sliding member 554 is rotatable relative to the plunger rod 532 and the thumb rest 538. In other examples, the wedge 572, in some examples together with the thumb rest 538, is rotatable relative to the sliding member 554 and the plunger rod 532.
[0118] In a modified example of the locking arrangement 550, the actuating member 570 includes a pair of engaging threads in place of the wedges 558, 572. In an example, a thread is provided at a distal portion of the sliding member 554 and a corresponding thread engaging with the thread on the sliding member 554 is arranged at an underside of the thumb rest 538 or as a separate part, for example, as a tubular spacer, between the thumb rest 538 and the sliding member 554. Rotation of the engaging threads relative to each other, for example, by rotating the sliding member 554, the tubular spacer, or the thumb rest 538, respectively, will change a distance by which the sliding member 554 is moved in the direction of the deformable element. In some examples, an actuating member 570 including a pair of engaging threads is further usable for adjusting, by corresponding rotation of the threads, a locking force which is exerted by the locking arrangement 550.
[0119]
[0120] In the locking arrangement 650, the at least one actuating member 670 includes at least one elastic finger 672, which extends from an underside of the thumb rest 638 of the plunger 630 and which engages with a contour 658 at the proximal end of the sliding member 654.
[0121] As shown in the upper portion (
[0122] As shown in the middle portion (
[0123] As shown in the lower portion (
[0124]
[0125] Instead of pulling the sliding member 654 in the outward direction, in some examples a user may simply push the thumb rest 638 in the inward direction to unlock the locking arrangement 650. As is apparent from the middle portion (ii) in
[0126]
[0127] The container 700 is pre-filled with a liquid 710. In addition, a gas 712, for example, air, is contained in a headspace of the container 700.
[0128] Concerning a motion of the plunger 130, a resultant force acting on the plunger 130 due to thermal expansion and/or contraction of a content of the container 700 depends, among other conditions, on a type and a quantity of the substances 710, 712 contained in the container 700.
[0129] In some examples, the deformable element of the locking arrangement 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, optionally at least 600 millibars, optionally at least 800 millibars, at a temperature of minus 80 degrees Celsius.
[0130] Furthermore, in some examples, the locking arrangement 150 is configured to reduce a motion of the plunger 130 relative to the container body 110 to less than 3 millimeters, optionally less than 2 millimeters, optionally less than 1.5 millimeters, optionally less than 0.5 millimeters, when applying a pressure difference of 500 millibars, optionally 600 millibars, optionally 800 millibars, at a temperature of minus 20 degrees Celsius, optionally minus 50 degrees Celsius, optionally minus 80 degrees Celsius.
[0131] The following parameters are fulfilled simultaneously in some examples of the container 700. The brimful volume of the container body 110 is 0.5 to 100 milliliters, optionally 1 to 20 milliliters, optionally 1 to 5 milliliters. In addition, the container 700 is prefilled with the liquid 710 by 10% to 90%, optionally 20% to 80%, optionally 30% to 70%, optionally 40% to 60% of the brimful volume of the container 700. Optionally, the liquid 710 includes a sugar or salt. In addition, the container (700) includes a headspace of gas (712), optionally air, of 0 to 10 millimeters, optionally 0.5 to 5 millimeters, optionally 1 to 4 millimeters, optionally 1.5 to 3 millimeters. In addition, a movement of the plunger rod is 3 millimeters or less, optionally 2 millimeters or less, optionally 1 millimeter or less, optionally 0.5 millimeters or less, optionally 0 millimeters, after one or both of the following test conditions were applied.
[0132] Test Condition 1: The pressure outside the container 700 with regard to the inside was reduced by 100 to 1000 millibars, optionally 200 to 900 millibars, optionally 300 to 800 millibars, more optionally 400 to 600 millibars, optionally 430 millibars for 1 second to 1 week, optionally 1 minute to 24 hours, optionally 1 hour to 6 hours, optionally 180 minutes.
[0133] Test Condition 2: The container 700 was stored at −150° C. to 25° C., optionally −120° C. to 0° C., optionally −100° C. to −15° C., optionally −90° C. to −40° C., optionally −80° C., for 1 second to 7 days, optionally 1 minute to 24 hours, optionally 1 hour to 6 hours, optionally 180 minutes.
[0134]
[0135] In the foregoing, examples of locking arrangements have been described in particular connection with a syringe. However, as will be appreciated, some or all of the described features and functions of a locking arrangement can be implemented correspondingly in connection with other types of containers, such as cartridges.
[0136] While this invention has been described with respect to at least one embodiment, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.