Medicine container having end plug, use of plug-securing part to secure end plug in medicine container, and plug-securing part
Patent Information
- Application Number
- JP2024221292
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2017-05-16
- Filing Date
- 2024-12-18
- Publication Date
- 2025-03-11
AI Technical Summary
【0009】 そのような薬剤容器において、前記エンドプラグは、前記薬剤容器の中にしっかり保持されている。前記プラグ固定部品により、前記エンドプラグが前記近位開口部を通って前記薬剤容器から移動することを防止でき、前記挿入状態で防止する。これに加えて、そのような薬剤容器のプラグ固定部品は、簡単に、特に手動で挿抜することができる。
Smart Images

Figure 2025032365000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to a drug container having an end plug, to the use of a plug fixing part for fixing an end plug of a drug container, and to the plug fixing part. [Background technology]
[0002] A plug fastening part and a drug container having an end plug and the use of the plug fastening part for fastening the end plug in the drug container are known. The plug is conventionally fastened in a syringe by a finger hook with an integrated plug fastening part. For two-chambered syringes, such fastening methods by the finger hook are also known. However, carpules, in particular two-chambered carpules, usually do not have a finger hook. Thus, the plug in the carpule is conventionally fastened by mounting the carpule in an application device, in particular a disposable pen, the piston rod of which fastens the end plug.
[0003] In addition, it is known that transport boxes for accommodating a number of carpules are provided with ridges at the bottom thereof, which ridges penetrate into the main body of the drug container in order to fix the end plugs arranged therein. The drug containers in such transport boxes are thus conventionally arranged between the bottom and the lid of the transport box, and the ridges, which start at the bottom, penetrate into the internal space of the body of the drug container during transport, limiting the movement of the end plugs arranged therein in the direction of the bottom. Summary of the Invention [Problem to be solved by the invention]
[0004] A disadvantage of this known prior art is that fixing the end plug by finger hook is only possible if the drug container has such a finger hook. However, fixing the end plug by attaching a carpule to an application device is cumbersome and expensive. Fixing the end plug by a transport box has the disadvantage that the ridge at the bottom of the box must exactly match the position of the end plug of the drug container along the central axis of the end plug. Therefore, only drug containers or sets of drug containers with an end plug position that exactly matches the length of the ridge can be reliably fixed in the transport box. Such transport boxes are also large and inefficient when trying to fix small amounts of drug containers with individually different end plug positions along the central axis of the drug container.
[0005] Due to the system used, air pockets occur in the filling chamber when filling the drug container. Particularly in two-chamber carpules, the amount of air in the total filling volume is quite large. Such air pockets cause forces acting on the plugs that delimit the chamber, in particular the end plugs, when the drug container and thus the end plugs are under the effect of negative pressure or vacuum. As a result, the end plugs can move, in particular during transportation of the drug container involving altitude changes, in particular during air transport or transportation in mountainous areas. Thus, pressure gradients occurring during transportation between the enclosed area of the drug container and the outside air can cause the end plugs to move, in particular in the direction of the proximal end of the drug container. As a result, the medically sterile field is contaminated or at least exposed to the risk of contamination.
[0006] It is an object of the present invention to provide a drug container and a plug fastening part which uses the plug fastening part and which avoids the disadvantages thereof.
[0007] This object is achieved by providing the subject matter of the independent claims. Advantageous embodiments are set forth in the dependent claims. [Means for solving the problem]
[0008] This object is achieved in particular by providing a drug container, in particular a syringe or carpule, particularly preferably a two-chambered syringe or two-chambered carpule, with a base body, the base body at least partially enclosing an internal space, the base body having a central axis and a proximal opening. An end plug is movable in the internal space along the central axis and is arranged in the internal space so as to separate a first region of the internal space, distal to the end plug, from a second region of the internal space, proximal to the end plug. The drug container is characterized in that a plug fixing part is provided which is at least partially insertable through the proximal opening into the second region of the internal space, the plug fixing part being held in a fixed position in the internal space by a form-fit and / or frictional fit, at least in a holding region, closer to the proximal opening than the end plug, when inserted into the internal space. The base body preferably has a rotationally symmetrical, particularly preferably cylindrical, shape and encloses the internal space, at least partially adapted for filling with a drug and / or additive. Together with the end plug and, if appropriate, further plugs or other closing elements, the base body completely seals at least a part of the interior space. The base body preferably also has at least one further closable opening. However, the main body particularly preferably has only the proximal opening and exactly one further closable distal opening. In the following, all other closable openings are assumed to be closed.
[0009] In such a medicament container, the end plug is held securely in the medicament container. The plug fixing part prevents the end plug from moving out of the medicament container through the proximal opening and in the inserted state. In addition, the plug fixing part of such a medicament container can be easily inserted and removed, in particular manually.
[0010] The end plug separates the first region from the second region by being in intimate contact with the inner wall of the internal space. This separation ensures the purity and / or sterility of the first region. The first region thus forms a closed space when the end plug is positioned as intended. Preferably, the first region is divided into two separate chambers by at least one further plug, in particular a center plug. In this way, the drug container forms a two-chamber system, in particular a two-chamber carpule or a two-chamber syringe.
[0011] The first region is adapted to contain a medicament and / or additive. In addition, the main body, the end plug and all other openings are adapted to seal the first region against external contaminants. The second region, on the other hand, is not necessarily sealed. On the contrary, an application device can act on the end plug via the second region in order to move the end plug towards the distal end and thereby remove the medicament and / or additive stored therein from the medicament container. The second region is thus in fluid contact with the surroundings of the medicament container via the proximal opening of the main body. As a result, the second region is not sterile and is not protected from contamination.
[0012] Due to the arrangement of the end plug and the first and second regions described herein, the first region is further from the proximal opening of the main body than the second region.
[0013] The plug fixation part is at least partially insertable, preferably inserted through the proximal opening into the second region of the internal space and, in an inserted state, can be removed from the second region of the internal space through the proximal opening. In addition, in an inserted state, the plug fixation part is movable along the central axis and is preferably mounted rotationally symmetrically, more preferably rotationally symmetrically with respect to the central axis. In addition, the plug fixation part is preferably connected to the inner or outer wall of the base body by a form-locking and / or frictional locking and is thereby held in a fixed position in the internal space. Preferably, the plug fixation part is alternatively or additionally held in a fixed position in the internal space by a form-locking and / or frictional locking by an element engaging with an external structure and / or the base body, in particular a transport container.
[0014] According to one embodiment of the invention, the plug fixation part is held in a positionally fixed position and / or arranged relative to the end plug such that movement of the end plug, in particular due to pressure, is limited by the plug fixation part in the proximal direction, in particular therefore movement of the end plug from the medicament container is prevented and limited by the abutment of the proximal end of the end plug against the distal end of the plug fixation part.
[0015] Particularly preferably, the plug fixing part directly abuts the end plug in the inserted state, thereby preventing movement of the end plug in the direction of the proximal opening.
[0016] In this way, a movement of the end plug in the direction of the proximal opening, which would compromise the sterility of the first region of the internal space, is preferably prevented by the positionally stable plug fixing part. When the end plug is completely moved into the second region of the internal space, the sterility of the first region of the internal space is particularly endangered. Therefore, preferably, the proximal movement of the end plug is limited by the plug fixing part so that the end plug cannot be completely moved into the second region. This is particularly ensured when the distal end of the plug fixing part is arranged at a distance from the proximal end of the end plug, which distance is smaller than the axial length of the end plug. Advantageously, the sterility of the first region is thus particularly reliably ensured. However, it is also possible for the proximal end of the end plug to abut against the distal end of the plug fixing part.
[0017] According to one embodiment of the invention, the plug fastening part interacts with the inner wall of the base body with a form-locking and / or friction-locking connection, which is particularly easy to establish and less prone to failure than a form-locking or friction-locking connection between the plug fastening part and an outer wall.
[0018] According to an embodiment of the invention, the plug fastening part preferably has at least one elastic retaining means, which is elastically acting at least radially relative to the central axis, and which is configured to hold the plug fastening part on the base body, preferably on the inner wall of the base body, in a frictional lock when inserted into the inner space. By such elastic retaining means, the plug fastening part is held in a fixed position in the inner space, at least in the retaining area, in a frictional lock. Preferably, a positive lock is made possible by the elastic retaining means, whereby the elastic retaining means is guided through a radial taper in the second area and engages behind the taper by widening due to its elasticity behind the radial taper. The drug container with such a plug fastening part has the advantage that the fastening of the end plug by the elastic retaining means is easy to perform, and therefore the insertion and removal of such a plug fastening part into and from the second area is particularly easy to perform, in particular quickly by hand.
[0019] According to a preferred embodiment, the elastic retaining means comprises a spring and / or a spring-like structure and / or a spring-like element and / or a vulcanized elastomer, preferably rubber, and / or a recess into which the material weakened zone, preferably the adjacent material, preferably the material adjacent outwardly perpendicular to the central axis, can elastically deform. Material weakened zone is here taken to mean an area with a material that is flexible and / or contractible with respect to the material surrounding the material weakened zone when a force is applied. The material weakened zone is therefore compressed more strongly than the material surrounding the material weakened zone when a force is applied. Alternatively or additionally, the material weakened zone is composed of a liquid and / or a gas, in particular air, and the gas and / or liquid of the material weakened zone can be displaced from the material weakened zone when a force is applied. Preferably, the elastic retaining means comprises a recess. The plug fixing part having such elastic retaining means can be produced in a particularly cost-effective manner and / or integrally and / or from the same material.
[0020] According to an embodiment of the invention, the plug fixation part has a round, cross or I-shaped cross section, at least in the distal region of the plug fixation part. A particularly favorable force arrangement for realizing the frictional connection is given by the cross section of the distal region of the plug fixation part, i.e. in the region before the insertion of the plug fixation part into the second region of the drug container. Thus, when the elastic retaining means is arranged and compressed in said distal region when inserted into the plug fixation part, the webs located opposite the central axis forming the cross or I-shaped cross section and / or the region opposite the central axis forming the round cross section are preferably precisely stabilized against each other. In this way, the radially acting forces providing the frictional connection are locally maximized and biasing force components are prevented. Moreover, such a cross section allows the plug fixation part to pass air at least in the distal region, and preferably over the entire area of the plug fixation part, which prevents the air from penetrating into the second region and sealing the area between the plug fixation part and the end plug when the plug fixation part is inserted into the drug container, which makes it possible in particular to increase or decrease pressure, in particular air pressure, between the plug fixation part and the end plug, during insertion and removal of the plug fixation part, thus preventing unintended movement of the end plug in the distal and / or proximal direction.
[0021] According to an embodiment of the invention, the plug fixation part has a locking structure, in particular at its proximal end, whereby in the region of the locking structure (51) the plug fixation part at least has a radial extension perpendicular to the central axis (M) in the inserted state which is at least greater than the minimum radial extension of the proximal opening (11) of the base body, preferably greater than the maximum radial extension, so that the insertion depth of the plug fixation part (39) into the drug container (1) is limited by the abutment of the locking structure (51) against the drug container (1). The locking structure is preferably arranged at an end of the plug fixation part, i.e. at a radial distance from the central axis of the base body in the inserted state, in particular on the outer side of the plug fixation part. Preferably, the locking structure is formed as a thickening or a protrusion with respect to the outer side. Particularly preferably, the locking structure is formed integrally with the plug fixation part and / or made from the same material.
[0022] If the radial extension of the at least one plug fastening part is at least greater than the minimum radial extension of the proximal opening of the main body, there is at least one rotational position about the central axis in which, in an inserted state, the locking structure abuts against the proximal end of the drug container, thus preventing the plug fastening part from penetrating further into the drug container. However, preferably, the radial extension of the at least one plug fastening part is greater than the maximum radial extension of the proximal opening of the main body, so that the insertion depth is limited in each rotational position of the plug fastening part by the abutment of the locking structure at the proximal end of the drug container.
[0023] In any case, the locking structure is disposed at an axial distance from the distal end of the plug fixing part that is less than or equal to the axial distance between the proximal end of the end plug and the proximal opening of the base body. Such a drug container has the advantage that the end plug disposed therein cannot be moved, in particular cannot be moved by the plug fixing part. Thus, the safety of the drug container and the drug and / or additive therein is improved.
[0024] According to an embodiment of the invention, a gripping portion is formed at the proximal end of the plug fastening part when the plug fastening part is inserted. The gripping portion has an undercut structure and / or an easy-to-grip material and / or a rough surface structure. An easy-to-grip material here refers in particular to non-slip materials and / or materials with a higher static friction than the static friction of other materials used for the plug fastening part and / or rubber and / or rubber-like materials. Such a gripping area makes the handling of the drug container easier. The plug fastening part of the drug container can thus be inserted and removed in a particularly simple and fast manner, in particular manually.
[0025] According to an embodiment of the invention, the medicament container comprises a safety indicator, preferably a label or a shrinkable sleeve, which is intended to allow the safety indicator to be modified, preferably broken or at least partially removed, by a movement of the plug fastening part (39) in the inserted state of the plug fastening part (39), and which is preferably arranged on the base body (7) and on the plug fastening part (39) in one area where the plug fastening part (39) adjoins the base body (7). The safety indicator preferably has a predetermined breaking point, in particular a perforation. Such a safety indicator preferably allows visual detection of whether the plug fastening part has moved. In particular in the case of a pressure-induced movement, such as occurs during transport, a movement of the end plug and / or the plug fastening part that compromises sterility is often not detected retrospectively, since the end plug returns to its original position when the external air pressure returns to its initial level. Preferably, only a temporary movement of the plug fastening part and / or the end plug can be detected later by the safety indicator described here. A safety indicator of the type described herein is irreversibly operated such that in the event of movement of the plug locking part, in particular in the event of sterility being compromised, the safety indicator does not return to its initial state when the end plug returns to its original position. Thus, a temporary movement will be recognized. This increases the safety of the drug container, in particular a drug-filled drug container. In an exemplary embodiment of a drug container with a safety indicator described herein, the plug locking part is preferably located directly adjacent to the end plug when inserted, so that the drug container is reliably sealed by the safety indicator and movement of the end plug, at least in the proximal direction, can be prevented.
[0026] According to an embodiment of the present invention, the plug fastener is made of polypropylene, polystyrene and / or at least one synthetic resin. Preferably, the plug fastener is manufactured in a plastic injection molding process. Drug containers with such a plug fastener have the advantage that they are particularly cost-effective.
[0027] According to an embodiment of the invention, the plug fastening part comprises a mechanically, preferably contactlessly, particularly preferably electromagnetically readable information carrier, in particular an RFID chip, by means of which content-specific and / or transport-specific and / or origin-specific information about the medicine container and / or its contents can be recorded and stored separately in a particularly cost-effective manner, so that such information attributable to the medicine container and / or its contents can be stored and retrieved quickly and efficiently.
[0028] According to an embodiment of the present invention, the plug fixing part is shaped so that the outer circumferential surface of the drug container is not covered when the plug fixing part is inserted, so that information attached to the outer circumferential surface can be recognized and handling of the drug container is improved.
[0029] According to a preferred embodiment, the plug fastening part of the medicament container is coloured, in particular monochrome or multicoloured, white or black, and / or is provided with a pattern or marking. The design of the plug fastening part is preferably a coding, in which at least one piece of information, in particular information relating to the medicament, the medicament dosage and / or the medicament composition, is associated with such optical properties, i.e. colours, patterns and / or letters. The medicament composition is understood in particular to be the composition of the various active ingredients and / or additives.
[0030] The present invention also includes a set or assortment of drug containers according to one of the embodiments described above, where each drug container is associated with a respective plug protection part, in particular colored in monochrome or multicolor, white or black, and / or provided with a pattern or marking.
[0031] The various drug containers of the set or assortment are optically marked by the color design of the plug fastening parts and / or their patterns or letters, whereby each marking, i.e. color, pattern and / or letter, is associated with specific information about the drug container, e.g. information about the drug, drug dose and / or drug composition in the drug container. The position of the end plug may in particular vary depending on the drug and / or drug composition contained in the drug container. Accordingly, the plug fastening parts associated with the drug containers preferably have different lengths so as to pass through the proximal opening and reach the respective position of the second region as close as possible. The different lengths of the plug fastening parts are preferably coded alternatively or additionally by color, pattern and / or letter.
[0032] In particular, if there is a set of drug containers, each drug container having a different plug fastening part, such coded information can be detected by optical control and associated with each drug container, particularly preferably also with the length of said plug fastening part along said central axis.
[0033] More preferably, the length of each plug fixing part is adapted to the position of a corresponding end plug in the drug container in the set, so that each plug fixing part directly abuts the corresponding end plug, thus enabling reliable and individual fixing of each individual end plug in a set of drug containers having the same main body but different end plug positions.
[0034] The invention also includes a set or assortment of plug fastening parts, in particular coloured in monochrome or multicolour, in white or black and / or provided with a pattern or marking, at least two of said plug fastening parts being in this case different from each other with regard to colour, pattern and / or character, whereby different information is associated according to different colours, patterns and / or characters, in particular coding, and said information preferably relating to the drug contained in the drug container secured by the respective plug fastening part and to the drug dosage and / or drug composition.
[0035] The object is also achieved by providing a transport container for at least one drug container, in particular with at least one receptacle for at least one drug container, wherein the receptacle has a length that corresponds to the axial length along the central axis of the drug container into which the plug fastening part is inserted. The drug container can therefore be stored in the receptacle of the transport container without play at least in the direction of its length. Advantageously, the drug containers stored in the transport container can also be stored perpendicularly to the central axis without play. In case of several receptacles in the transport container, it is advantageously possible to ensure the storage of a plurality of drug containers with appropriately associated plug fastening parts without compromising the safety of the drug container and / or the sterility of the first area, even if the drug containers have different end plug positions along the central axis. In particular, each receptacle of the drug container may have the same length. By adapting the plug fastening part, a set of drug containers can be arranged in the transport container, said set comprising at least two drug containers, each with different end plug positions.
[0036] The object is further achieved by providing a plug fixing part for use in a drug container, in particular for fixing an end plug. The drug container is preferably conceived according to one of the above-mentioned embodiments. The invention requires a drug container having a base body at least partially enclosing an internal space, a central axis and a proximal opening. Wherein the end plug is arranged in the internal space such that the end plug is movable in the internal space along the central axis and separates a first region of the internal space, distal to the end plug, from a second region of the internal space, proximal to the end plug. The use of the plug fixing part is characterized in that the plug fixing part is inserted through the proximal opening into the second region and is arranged closer to the proximal opening than the end plug. Wherein the plug fixing part is held in a holding area of at least the second proximal region of the drug container by a form-fit and / or a friction-fit. This results in the advantages already mentioned above in relation to the drug container. When using the plug fixing part in this way, the end plug is in particular held securely in the drug container.
[0037] According to one embodiment of the use, the movement of the end plug is limited by the plug fixation part, preferably in such a way that sterility of the first region of the interior space is ensured, in particular in the proximal direction, by abutting a proximal end of the end plug against a distal end of the plug fixation part.
[0038] Said object is also achieved by providing a plug fastening part configured for use in a drug container according to one of the embodiments described above, thereby obtaining the advantages mentioned above.
[0039] Overall, the drug container, the transport container, the plug fixing part and the use of the plug fixing part in the drug container as presented herein result in an end plug being particularly securely retained in the drug container. [Brief description of the drawings]
[0040] The invention will now be described in detail with reference to the drawings. [Figure 1] 1 illustrates a side view of an exemplary embodiment of a drug container. [Diagram 2] 2 shows an enlarged view of the proximal end of the medicament container according to the embodiment of FIG. 1. [Diagram 3] FIG. 3 shows a perspective view of the plug fastening part according to FIGS. 1 and 2; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0041] FIG. 1 shows an embodiment of a drug container 1, in this case a two-chamber carpule 3, in a longitudinal section. The drug container 1 is stored in a transport container 5 along a central axis M without play. The drug container 1 comprises a main body 7 which is substantially cylindrical in shape and encloses an internal space 9, the central axis M and a proximal opening 11 and a distal opening 13. An end plug 15 is arranged in the internal space 9 of the main body 7 such that the end plug 15 is movable in the internal space 9 along the central axis M and separates a first region 17 distal to the end plug from a second region 19 of the internal space 9 proximal to the end plug. The first region 17 is here divided by a center plug 21 into a first chamber 23 and a second chamber 25.
[0042] The distal opening 13 is closed by the closure element 27, so that the second chamber 25 forms a closed space bounded by the main body 7, the center plug 21 and the closure element 27. A freeze-dried part 29, substantially surrounded by air 31, is stored in the interior space of the second chamber 25. Likewise, a bypass 33 is formed in the area of the second chamber 25 of the main body 7. The movement of the center plug 21 along the central axis M in the direction of the distal opening allows the contents of the two chambers 23, 25 to mix.
[0043] The first chamber 23 comprises the solvent 35 and the gas bubble 37. The first chamber forms a closed space delimited by the center plug 21, the base body 7 and the end plug 15. An application device, not shown here, makes it possible to move the end plug 15 and, at the same time, the center plug 21 in the direction of the distal opening 13 after the distal opening 13 has been opened. When the center plug 21 reaches the axial cross section of the bypass 33, the contents of the first chamber 23, i.e. essentially the solvent 35, move into the second chamber 25. This makes it possible to mix the contents of the two chambers. When the end plug 15 is further moved by the application device in the direction of the distal opening 13, the mixed contents of the second chamber 25 are expelled from the internal space 9 via the distal opening 13.
[0044] In the exemplary embodiment shown here, the plug fixation part 39 is arranged in the second region 19, such that the end of the end plug 15 facing the proximal opening 11 is directly adjacent to the end of the plug fixation part 39 facing the distal opening 13. Thus, movement of the end plug 15 via the proximal opening 11, in particular by an application device, is not possible here and the end plug is therefore protected from movement in the direction of the distal opening 13 and therefore from any displacement.
[0045] Figure 2 shows an enlarged view of the proximal region of the medicament container 1 according to figure 1. Identical elements and elements having the same function are provided with the same reference numbers, and in this respect reference is made to the above description.
[0046] From figure 2 it becomes clear that the plug fastening part 39 is held in the second region 19 of the inner space 9 by means of at least one elastic retaining means 41, in this case a number of elastic retaining means 41, by means of a frictional connection. The at least one elastic retaining means 41 has a material weakened zone 43, which is formed here as a recess, to which a web-like structure 45 of the plug fastening part 39, seen radially outwards, is connected, which has elastic properties.
[0047] When the plug fastening part 39 shown here is in its inserted state, the web-like structure 45 elastically deforms into the material weakened zone 43, so that a spring force acts from the inside on the inner wall 47 of the base body 7 and holds the plug fastening part 39 in a frictional connection in the holding area 49 of the internal space 9.
[0048] Figure 3 shows a perspective view of the plug fastening part 39 according to figures 1 and 2. In this view, the plug fastening part 39 has a cross-shaped cross section with two diametrically opposed elastic retaining means 41, which starts from the distal end and extends over a large area of the plug fastening part 39, in particular over the distal area, which in the inserted state is located in the second area 19 of the base body 7.
[0049] 3, the plug fastening part 39 is not in an inserted state, so the elastic retaining means 41 are relaxed and no mechanical stress energy is stored therein. The web-like structures 45 therefore project radially, i.e. perpendicularly to the central axis M, towards the areas adjacent to them. By inserting the plug fastening part 39 into the drug container 1 with a cylindrical interior space 9, these web-like structures 45 deform radially inwards, in the direction of the central axis M, into the material weakened zones 43.
[0050] Furthermore, in FIG. 3 it can be seen that the plug fastening part 39 has a locking structure 51 in its rear distal region, which in the inserted state of the plug fastening part 39 faces away from the distal opening 13. FIG. 3 shows three locking structures 51, with a fourth locking structure 51 being arranged opposite the viewer. Each of the locking structures 51 is formed as a protruding step on one of four mutually perpendicular webs 53 forming a cross-shaped cross section. In each case, the two locking structures 51 arranged opposite each other extend over a width greater than the diameter of the proximal opening 11 of the drug container 1. In particular, each locking structure 51 of the plug fastening part 39 shown here has, in the inserted state, a radial extension perpendicular to the central axis M that is greater than the radius of the proximal opening 11 of the drug container 1. This prevents the plug fastening part 39 from being inserted too deeply into the drug container 1 when the plug fastening part 39 is inserted into the drug container 1. The plug retainer 39 thereby prevents the end plug 15 from moving from its intended position towards the distal opening 13 .
[0051] In a particularly preferred embodiment of the plug fixing part 39 of the pharmaceutical container 1, the distance between the protruding step of the locking structure 51 and the distal end of the plug fixing part 39 is adapted to the axial position of the end plug 15 of the pharmaceutical container 1 such that, in the inserted state, the plug fixing part 39 abuts against the proximal end of the pharmaceutical container 1 by means of the locking structure 51 and the distal end of the plug fixing part 39 is directly adjacent to the proximal end of the end plug 15 without the end plug 15 being displaced from its original position upon insertion of the plug fixing part 39.
[0052] It should be noted that a gripping portion 55 is formed at the proximal end of the plug fastening part 39, which is particularly clearly visible in Fig. 3. Here, the gripping portion 55 is formed by a round gripping plate having an undercut structure 57 starting from the proximal end, which is particularly visible in Fig. 2. This allows the plug fastening part 39 to be particularly easily gripped, in particular manually, in the inserted state in order to remove the plug fastening part 39 from the medicament container 1.
[0053] Overall, it can be seen that in the pharmaceutical container 1 proposed herein, the plug fixing part 39 and the use of the plug fixing part 39 in the pharmaceutical container 1 enable the end plug 15 of the pharmaceutical container 1 to be fixed in a customizable manner for the pharmaceutical container 1, particularly with high reliability and versatility.
Claims
1. A pharmaceutical container (1), in particular a syringe or carpule, A base body (7), The base body (7) at least partially encloses an internal space (9), The base body (7) has a central axis (M) and a proximal opening (11); an end plug (15) in the internal space (9) is movable along the central axis (M) and is disposed in the internal space (9) so as to separate a first region (17) of the internal space (9) distal to the end plug (15) from a second region (19) of the internal space (9) proximal to the end plug (15); a plug fastening element (39) at least partially insertable through the proximal opening (11) into the second region (19) of the interior space (9); The drug container (1), when inserted into the internal space (9), is held in a fixed position in the internal space (9) by a form-fitting and / or frictional fit, at least in a holding area (49), closer to the proximal opening (11) than the end plug (15).
2. A drug container (1) according to claim 1, The plug fixing part (39) is arranged in a fixed position and / or relative to the end plug (15) such that movement of the end plug (15) in a proximal direction is restricted by the plug fixing part (39).
3. A drug container (1) according to claim 1 or 2, The plug fastening part (39) interacts with an inner wall (47) of the base body (7) of the medicament container (1) with a positive and / or frictional fit.
4. A drug container (1) according to any one of claims 1 to 3, The plug fixing part (39) preferably has at least one elastic retaining means (41) acting at least in a radial direction relative to the central axis (M) and having elasticity, the elastic retaining means (41) being configured to frictionally retain the plug fixing part (39) on the base body (7), preferably on an inner wall (47) of the base body (7) when inserted into the internal space (9).
5. A drug container (1) according to any one of claims 1 to 4, The elastic retaining means (41) is a) a spring, and / or b) a spring-like structure, and / or c) a spring-like element, and / or d) a vulcanized elastomer, preferably rubber, and / or e) A zone of weakening of material (43), preferably of the medicament container (1), in which the adjacent material, preferably the outwardly adjacent material perpendicular to said central axis, has an elastically deformable recess therein.
6. A drug container (1) according to any one of claims 1 to 5, The plug fastening part (39) has a round, cross-shaped or I-shaped cross section, at least in a distal region of the plug fastening part (39).
7. A drug container (1) according to any one of claims 1 to 6, The plug fixing part (39) has a locking structure (51), The plug fixing part (39), in the region of the locking structure (51), has at least a radial extension perpendicular to the central axis (M) in the inserted state, which is greater than at least the minimum radial extension of the proximal opening (11) of the base body, preferably greater than the maximum radial extension, such that the insertion depth of the plug fixing part (39) into the drug container (1) is limited by the abutment of the locking structure (51) against the drug container (1).
8. A drug container (1) according to any one of claims 1 to 7, When inserted, the plug fastener (39) has a gripping portion (55) formed at its proximal end, the gripping portion (55) being a) an undercut structure (57), and / or b) a material that is easy to grasp; and / or c) Rough surface structure A drug container (1) comprising:
9. A drug container (1) according to any one of claims 1 to 8, The drug container (1) has a safety indicator, preferably a label or a shrinkable sleeve, which is arranged on the base body (7) and on the plug fixing part (39) in one area where the plug fixing part (39) is adjacent to the base body (7) such that, in an inserted state of the plug fixing part (39), movement of the plug fixing part (39) allows the safety indicator to be changed, preferably damaged or at least partially removed.
10. A drug container (1) according to any one of claims 1 to 9, The plug fixing part (39) is a drug container (1) made of polypropylene, polystyrene, and / or at least one synthetic resin.
11. A drug container (1) according to any one of claims 1 to 10, The plug fastening part (39) is adapted to receive a medicine container (1) which comprises a mechanically, preferably contact-free, particularly preferably electromagnetically readable information carrier, in particular an RFID chip.
12. A drug container (1) according to any one of claims 1 to 11, The plug fixing part (39) is shaped so that the outer circumferential surface of the drug container (1) is not covered when inserted.
13. Use of a plug fastening part (39) for fastening an end plug (15) of a medicament container (1) according to any one of claims 1 to 12, comprising The medicament container (1) comprises a base body (7) at least partially enclosing an interior space (9), a central axis (M) and a proximal opening (11); the end plug (15) is disposed within the internal space (9) such that the end plug (15) is movable within the internal space (9) along the central axis (M) and separates a first region (17) of the internal space (9), distal to the end plug (15), from a second region (19) of the internal space (9), proximal to the end plug (15); Use of a plug fixing part (39), wherein the plug fixing part (39) is positioned closer to the proximal opening (11) than the end plug (15), and the plug fixing part (39) is inserted through the proximal opening (11) into the second region (19) such that the plug fixing part (39) is held in a holding region (49) of at least the second region of the drug container (1) by a form-fitting and / or frictional fit.
14. Use of a plug fastening part (39) according to claim 13, comprising: Use of a plug fixing part (39), in which movement of the end plug (15) is limited by the plug fixing part (39), preferably in such a way that sterility of the first region (17) of the internal space (9) is ensured.
15. A plug fixing part (39) adapted for use in a medicament container (1) according to any one of the preceding claims.