Container, connection and production device

The container design addresses seal reliability and handling force issues by reducing wall thickness and incorporating a pre-surface for minimal force connection, ensuring effective sealing and stable ampoule operation.

EP3687474B1Active Publication Date: 2026-05-20ROMMELAG ENGINEERING GMBH
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Patent Information

Authority / Receiving Office
EP · EP
Patent Type
Patents
Current Assignee / Owner
ROMMELAG ENGINEERING GMBH
Filing Date
2018-09-18
Publication Date
2026-05-20

AI Technical Summary

Technical Problem

Existing containers, particularly ampoules, face challenges in achieving reliable seals and consistent handling forces due to irregularities in secondary sealing lips and increased friction, especially when using materials like polypropylene or polyethylene, leading to potential leaks and difficult handling.

Method used

A container design with reduced wall thickness in the sealing area, featuring a pre-surface transitioning seamlessly into the insertion functional surface, and a narrow, radially elastic design, allowing for minimal force connection and improved torsional stability, using a blow-molding process.

Benefits of technology

Ensures a reliable seal with minimal actuation forces, reduces geometric tolerance sensitivity, and facilitates mass production, while preventing leaks and buckling, even with soft materials like polypropylene or polyethylene.

✦ Generated by Eureka AI based on patent content.

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Abstract

A container, more particularly an ampule, made of plastic material, having a container part (10) for receiving a container content (14), which can be dispensed through a container opening (12) which is closed by a head part (18) that can be separated along a separating point (16), on which head part a neck part (20) abuts, said neck part having a plurality of different functional surfaces on the inner circumference side, a support functional surface (44) of said functional surfaces being provided for sealing with respect to a removal body (32), which is provided for removing the container content (14) when the container opening (12) is opened, wherein in addition to the available functional surfaces, a front surface (50) is provided as an additional functional surface on the inner side (40) of the neck part, said front surface differing geometrically from the contact functional surface (44), is characterised in that the front surface (50) seamlessly transitions into the contact functional surface (44), and that the front surface (50) and the contact functional surface (44) are accommodated in the neck part (20) between the other functional surfaces.
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Description

[0001] The invention relates to containers, in particular ampoules, with the features in the preamble of claim 1.

[0002] A container of this type is regularly used for medical purposes and can be connected, for example, via a conical connection to the outlet of a dispensing device, such as a syringe. The conical connection can be lockable (e.g., a Luer-Lock connection according to ISO 80369-7:2016) or non-lockable (e.g., a Luer-slip connection according to ISO 80369-7:2016). These and other connection geometries and their variants used for fluid dispensing, for example, for enteral (ENFit, ISO 80369-3:2016) or neural (NRFit, ISO 80369-6:2016) application, are described in detail in the standards listed.

[0003] The preferred connections for parenteral applications – for example, for injection syringes – feature a conical connection with a taper ratio of 6%, corresponding to a cone angle of 3.43 degrees. These connections are also known as Luer connections. These well-known connection geometries utilize relatively large sealing surfaces that create the necessary reliable seal between the components over a relatively long conical area. This requires very high surface quality to ensure the desired, reliable seal, for example, between the injection syringe and needle. This can be readily achieved with injection-molded components using rigid and semi-rigid materials, such as plastics like polycarbonate (PC), styrene acrylonitrile (SAN), polystyrene (PS), etc. This also results in low joining forces for the user.However, combining injection syringes as a dispensing device with filled drug containers is particularly challenging.

[0004] If a container is to be manufactured cost-effectively in large quantities using other plastic materials (polypropylene, polyethylene) as described above, for example, using blow molding processes, which preferably include blow molding, filling, and sealing, leaks occurring during the removal process from the container using the dispensing device cannot always be reliably prevented, which can pose an undesirable risk to the patient. Therefore, it is important to ensure sufficient tightness of the dispensing connection, both against the ingress of potentially contaminated air into the container and against the unintentional escape of fluid from the container.

[0005] In view of the requirements explained above, it has already been proposed for a container of this type according to US 2016 / 0200484 A1 to provide, in addition to the large conical primary sealing surface over the entire neck area (Figs. 6 to 8), an additional secondary seal in the form of a sealing lip at axial distance, which, after the head part is cut off and the container opening is released, extends into the environment and rests against the extraction body of the extraction device as soon as the extraction body engages in the container.

[0006] Between the additional, upper sealing lip and the spaced-apart lower conical sealing surface, two further functional surfaces are arranged, one of which, the third functional surface, extends via a conical inner shoulder along a parting line ( Fig. 4 ) transitions into the conical sealing surface. The fourth functional surface adjoins this third functional surface, transitions into the sealing lip, and thus forms a cylindrical circumferential surface on the inner side of the neck section, which is penetrated by the dispensing body during a dispensing process. This fourth functional surface, in conjunction with the adjacent outer wall sections of the neck section, forms two rectangular retaining ribs with a wider diameter. When the container is upright, an additional container circumferential wall rests against the underside of these ribs, and they provide an external mounting point for the dispensing system. The third and fourth functional surfaces, which maintain an axial distance between the primary and secondary seals (conical sealing surface and sealing lip), surround the dispensing body that engages with the container at a radial distance and therefore do not perform a sealing function.

[0007] However, achieving a consistently reproducible sealing lip as a reliable secondary seal appears difficult, as the thin sealing lip only forms after the user removes the cap part. This means that user-specific and handling-related irregularities in the sealing lip cannot be reliably ruled out, thus calling its reproducible sealing function into question.

[0008] The additional secondary sealing required naturally creates additional friction between the insertion and / or removal of the dispensing body and the container in the area of ​​its neck, which leads to increased actuation or joining forces when making the fluid-carrying connection, making handling more difficult overall, especially if the operator wears appropriate gloves for hygienic reasons.In order to safely absorb such increased handling and connection forces, especially when inserting the removal body, the neck wall is made particularly thick in the area of ​​the contact surface to prevent the neck from buckling in this area; however, increased operating forces are again necessary here to be able to insert the conical removal body in this area of ​​the neck with increased wall thickness by widening it accordingly along the contact surface.

[0009] The two locking lugs on the outer circumference of the neck, which are diametrically opposed to each other on the longitudinal axis of the container, also provide the possibility of clamping the dispensing device to the dispensing body with the open container by forming a LuerLock connection; however, the disadvantageous arrangement of the two locking lugs in a common plane transverse to the longitudinal axis of the container easily leads to over-tightening of the locking thread of the dispensing device, which clearly unsettles the user, as he must assume a defect in the container.

[0010] US 8,096,433 B2 describes a container, in particular an ampoule, made of plastic material with the features in the preamble of claim 1, comprising a container part for receiving container contents that can be dispensed via a container opening, which is closed by a head part that can be detached along a separation point, to which a neck part is attached, which has four different functional surfaces on its inner circumference, of which a first contact functional surface serves to seal against a dispensing body that is provided for dispensing the container contents when the container opening is released, wherein, in addition to the first contact functional surface, a second functional surface is provided on the inside of the neck part, which differs geometrically from the first contact functional surface, wherein the second functional surface transitions seamlessly into the first contact functional surface.wherein the front surface and the first functional surface are located between a third functional surface and a fourth functional surface in the neck part, and wherein the first functional surface and the front surface are overlapped at their adjacent outer wall areas by at least two webs which at their free ends each extend into the adjacent outer wall areas of the third and fourth functional surfaces.

[0011] Further containers are shown in DE 28 27 227 A1, US 2016 / 0200484 A1, EP 2 266 521 A1, DE 39 16 840 A1, US 7 185 790 B2, JP S56-94704 B2 and US 2014 / 0039444 A1.

[0012] Based on this state of the art, the invention aims to create a container that is improved compared to the known container.

[0013] A container with the features of claim 1 in its entirety solves such a problem. Further advantageous embodiments of the solution according to the invention are the subject of the dependent claims.

[0014] The container according to the invention is characterized in that the opening angle of the front surface, which is designed in the form of a cone, is 10 to 40 degrees.

[0015] It is further provided that a pre-surface, acting as an additional functional surface, seamlessly transitions into the insertion functional surface, and that the pre-surface and the insertion functional surface are located between the other functional surfaces in the neck section. The container is further characterized by a significantly reduced wall thickness in the area of ​​the pre-surface, and especially in the area of ​​the insertion functional surface, compared to the average wall thickness in the neck section. This results in a low radial stiffness of the sealing area (partial area of ​​the insertion functional surface depending on the detailed geometry of the dispensing body), which is crucial for a reliable seal, as only minimal forces are required for its expansion by the dispensing body. Furthermore, it is advantageous to design the insertion functional surface to be as short as possible in the axial direction to ensure that the ampoule exhibits sufficient torsional stability.This, in turn, is important to ensure that the ampoule opens at the designated separation point and not in the area of ​​the insertion surface, which would render the container unusable. Furthermore, the short design of the insertion surface prevents the container from buckling or kinking at the neck during insertion of the dispensing element. The term "pre-surface" is intended to clarify that this is located in front of the insertion surface in the direction of insertion of the dispensing element into the container. The container is also preferably manufactured using a blow-molding, filling, and sealing process, which has become known in the industry under the brand name bottelpack®.

[0016] The reduction in the length of the functional area of ​​the system, achieved through the seamlessly adjacent surface at the head, surprisingly enables a reliable seal while simultaneously requiring minimal force to connect the dispensing body to the container. For reasons of production reliability in the blow-molded ampoules, the resulting short surface pressure with its increased sealing force is preferable to conventional surface pressure, as it inherently compensates for geometric tolerances in the container neck during the joining process. Thus, within a predefined tolerance range, an effective seal is created between the inner surfaces of the container neck and the dispensing body, even with high local pressure, while overall forces are reduced due to the smaller effective sealing area.

[0017] In a preferred embodiment of the container, it is provided that the aforementioned differences in the properties between the functional surface and the pre-surface are used to improve the insertion force of the extraction body as well as the sealing force effect in their Longitudinal extent and / or wall thickness in conjunction with adjacent outer wall sections of the neck section and / or surface slope can be seen.

[0018] This allows for a narrow sealing surface (part of the functional area, dependent on the geometry of the dispensing body) without compromising the overall stability of the neck section. Furthermore, the narrow width and low stiffness of the sealing area significantly reduce the angular tolerance requirements of the functional area, leading to improved suitability for mass production, particularly when using soft materials such as polypropylene (PP) or polyethylene (HDPE, LDPE). Consequently, the container can be manufactured cost-effectively in large quantities using a conventional blow molding, filling, and sealing process.

[0019] A radially elastic design of the container opening in the sealing surface area is achieved by reducing the average wall thickness of the front surface and / or the contact surface by approximately 20% to 50%, preferably 20% to 30%, compared to the average wall thickness of the other functional surfaces, taking into account the adjacent outer wall sections. This means that the overall wall thickness in the actual quasi-sealing line area is reduced while maintaining sufficient axial stiffness to prevent buckling, thus ensuring a secure connection between the dispensing body and the container for dispensing contents with minimal actuation forces.

[0020] In a particularly preferred embodiment of the container, the contact surface forms a contact cone with an opening angle of 3.43 degrees (cone angle) or greater relative to the container's longitudinal axis, wherein the corresponding opening angle of the upstream surface is 30 degrees, or a slant of 15 degrees, i.e., half the opening angle. In particular, if the cone angle of the container in the area of ​​its dispensing point is greater than 3.43 degrees relative to a cone angle of the dispensing body, for example, in the form of a syringe, with a male cone section of 3.43 degrees or 6% according to ISO 80369-7:2016, a smooth connection process for the dispensing body is achieved with low actuating forces and simultaneously very good fluid sealing.This is also aided by the fact that the opening angle of an additional conical pre-surface is 30 degrees; a value that, on the one hand, ensures a high line pressure between the contact functional surface and the removal body and, on the other hand, forms an additional insertion aid in the sense of a conical extension for the free end face of the removal body, in order to further facilitate the insertion process in the direction of the contact functional surface.

[0021] In a further preferred embodiment of the container according to the invention, it is provided that it is equipped with additional functional surfaces on the inside of the neck section in order to further stiffen the neck section, wherein one of the additional functional surfaces has a locking mechanism for the dispensing body on its adjacent outer wall section, preferably in the form of a threaded section, which is preferably formed from two partial threads. With this fastening mechanism according to the invention, it is ensured that unintentional over-tightening cannot occur when screwing the dispensing device onto the dispensing body, so that a secure thread engagement is achieved in every case, in which the sealing cone of a lockable connection is pressed into the mating seat in a sealing manner.

[0022] In another preferred embodiment with a locking mechanism (for example, a Luer-Lock connection), an increased distance of more than 3 mm, preferably more than 4 mm, and particularly preferably more than 5 mm, is provided between the head-side end of the contact surface and the container opening. This ensures that, during the connection process, the partial threads are engaged first before the sealing pressure is generated. This significantly improves handling for the user.

[0023] To ensure the safe use of dispensing devices with dispensing bodies of varying lengths (only their minimum length is specified in the standard), it is also advantageous if, after the connection process is complete, the upper edge of the opened container does not rest axially against the dispensing device. This is achieved—in contrast to the arrangement shown in US 2016 / 0200484 A1—by ensuring that the distance from the head end of the partial threads to the separation point (the upper edge of the opened ampoule) is very small and no more than 2 mm, preferably less than 1 mm.

[0024] The functional surface of the system and the front surface are overlapped on their adjacent outer wall areas by at least two webs, which preferably diametrically opposite each other to the longitudinal axis of the container, at their free ends each transition into the adjacent outer wall areas of the third and fourth functional surfaces and thus stiffen the relevant sealing area in the middle of the neck part essentially axially, and increase its torsional resistance moment against unintentional opening in the sealing area, but do not significantly increase its radial stiffness.

[0025] The solutions according to the invention are explained in more detail below with reference to exemplary embodiments shown in the drawing. The drawings are presented in a general and not to scale representation. Fig. 1 shows a front view of a filled container in the form of an ampoule; Figs. 2a to 1 show an enlarged view of the upper part of the container. Fig. 1 before ( Fig. 2a ) and schematically shown in cross-section after opening ( Fig. 2b ) by removing the head section at the separation point (16), as well as ( Fig. 2c ) in a partially enlarged view; Fig. 3 in side view of the container after the Fig. 1 ; Fig. 4, in the form of a partial longitudinal section, shows the connection area of ​​the container connected with a lockable conical connection; and Figs. 5 and 6, once in elevation and once in longitudinal section, show a section of a filling mandrel for producing a neck part and filling a container according to the Fig. 1 bis 4 .

[0026] The Fig. 1 Figure 1 shows a single-piece container in the form of an ampoule made of plastic material, consisting of a container part 10 for receiving a liquid or semi-solid contents 14 for medical purposes or the like, which can be dispensed through a container opening 12. The container opening 12 is closed along a separation point 16 by a detachable head 18, to which a neck 20 is attached, transitioning into the main container part 10. The head 18 has a handle 22 with which, with minimal actuation torque / force, the head 18 can be twisted off the neck 20 at the separation point 16, thus releasing the container opening 12. A schematic cross-sectional view of the exposed container opening 12 after detachment of the head 18 using the handle 22 is shown as an example in Figure 1. Fig. 2b depicted.

[0027] On the outer circumference, in the upper region of the neck part 20, a portion of a threaded section 24 in the form of a screw thread is shown, which in this case is formed from two partial thread sections 26, 28, one of which is on the front of the neck part 20 as shown in the illustrations. Fig. 1 und 2a extends and a partial thread section 28 rearward according to the representation of the side view after the Fig. 3 The two partial thread sections 26, 28 close with their central thread profiles in the area of ​​their rearward meeting as shown in the illustration. Fig. 3 at an angle of 70 to 80 degrees with the longitudinal axis 34 of the container. The aforementioned threaded section 24 on the outer circumference of the neck part 20 serves for locking with a dispensing device 30 with a conical dispensing body 32, as is partially found in the Fig. 4 is shown as an example.

[0028] Such a sampling device 30 is, for example, part of a syringe, the sampling body 32 of which serves to extract the container contents 14 from the container part 10 when the container opening 12 is released.

[0029] As further explained in Fig. 2a bis c and Fig. 4 As shown, a multitude of different functional surfaces are present on the inner surface 40 of the neck section 18. The neck section 20 connects to a transition arc 42 on the upper surface of the container section 10 and extends from there between the container section 10 to the separation point 16, to which the head section 18 connects. One of these functional surfaces forms a contact surface 44. A portion of this contact surface 44, dependent on the specific detailed geometry of the dispensing body 32, serves to seal against the dispensing body 32 of the respective dispensing device 30. If the circumferential contact surface 44 is fictitiously extended downwards, these extensions 46 form a conical angle of 3.43 degrees with each other, thus creating a preferred connection with a 6% cone ratio. The outer wall 48 of the dispensing body 32, which tapers conically downwards in this respect, also has a corresponding slope.Provided that the sampling device 30 with conical sampling body 32 is fully inserted along the neck part 20 (see . Fig. 4 ), is a part of the outer wall 48 in a sealing system with at least a part of the system's functional area 44. According to the illustration according to the Fig. 4 The dispensing device 30 is fully connected, and an internal thread 38 of the dispensing device 30 is locked via the partial threads 26, 28 on the neck part 20. A free length tolerance compensation gap 61 remains between the head end of the neck part 20 and the dispensing device 30, which allows the safe use of dispensing devices 30 with dispensing bodies 58 of different lengths. This is achieved by making the distance C of the head end of the partial threads from the separation point (the upper edge of the opened ampoule) very small and no more than 2 mm, preferably less than 1 mm.

[0030] In View towards the Fig. 4 As seen, an additional functional surface, the pre-surface 50, is molded onto the inner side 40 of the neck section 20 above the contact surface 44. This additional functional surface 50 transitions seamlessly into the contact surface 44, with the pre-surface 50 and the contact surface 44 being located between the other functional surfaces in the neck section 20, as will be explained in more detail below. In particular, the pre-surface 50 differs from the contact surface 44, which adjoins the container body seamlessly, in at least one property.

[0031] In any case, it should be ensured that the existing difference in properties between the functional surface 44 and the additional pre-surface 50 serves to guarantee that, when the extraction body 32 is inserted, an increased sealing pressure can act on it simultaneously with a reduced sealing surface. Firstly, it is specifically provided that the functional surface 44 has a small width B (see Fig. 4 , however not to scale) is executed, wherein B is less than 3 mm, preferably less than 2 mm, particularly preferably less than 1 mm.

[0032] Furthermore, it is provided that, taking into account the adjacent rotationally symmetrical outer wall section 54 of the functional surface 44 and the outer wall section 56 of the additional functional surface 50, the mean wall thickness is reduced by approximately 20% to 50%, preferably approximately 20% to 30%, at least in a partial area of ​​the functional surface 44 and / or a partial area of ​​the surface 50, compared to the mean wall thickness in the area of ​​the other functional surfaces 66, 70. Here, a mean wall thickness is to be assumed in each case, since at least the functional surfaces 44 and 50 have a corresponding inclination, whereas, in particular, according to the illustrations, the other functional surfaces 66, 70 are not considered to have a mean wall thickness. Fig. 1 bis 3 The outer circumference of the outer wall sections 54, 56 is essentially cylindrical. The average wall thickness in the aforementioned sealing area, including the two functional surfaces 44, 50, is therefore less than 4 mm, preferably less than 3 mm, and particularly preferably less than 2 mm. This results in a very favorable elastic design of the container or ampoule opening in the aforementioned sealing area in the radial direction, due to the corresponding reduction in wall thickness. Thus, in the axial longitudinal extent of the container body 10, a high axial stiffness is achieved in the neck section 20 to prevent indentation during insertion / connection with the dispensing body 32.

[0033] In a particularly preferred embodiment, the opening angle α of the additional pre-surface, determined in relation to the contact cone of the circumferential contact functional surface 44, is approximately 10 to 50 degrees, preferably 20 to 40 degrees, and particularly preferably 30 degrees. This enables jam-proof insertion, which can be achieved with low force and without the formation of abrasive particles. This is very advantageous compared to the prior art (US 2016 / 0200484 A1), which requires the mandatory installation of a sealing lip at the free end region of the neck part for improved sealing.

[0034] Accordingly, the solution is based on the principle that a high local pressure, a quasi-line pressure, leads to improved sealing, whereby overall lower forces are required due to a reduced sealing surface to move the dispensing device 30 with the dispensing body 32 into the final dispensing position in the neck part 20 of the container or ampoule. This has no equivalent in the prior art.

[0035] In another preferred embodiment with a locking option (for example, LuerLock connection), an increased distance D (see Fig. 4 A gap of more than 3 mm, preferably more than 4 mm, and particularly preferably more than 5 mm, is provided between the container opening 12 and the head-side end of the functional surface 44. This ensures that, during the connection process, the threads are engaged first before the sealing pressure is created between a portion of the functional surface 44 and the dispensing body. This significantly facilitates the connection between the dispensing device and the container.

[0036] For improved sealing and insertion of the extraction body 32, the contact surface 44 can be designed to form a contact cone with an opening angle of more than 3.43 degrees relative to the longitudinal axis 34 of the container (corresponding to a 6% cone ratio according to ISO 80369-7:2016). Surprisingly, it has been shown that, despite the different cone angles, a reliable seal is achieved between the 3.43-degree cone of the extraction body 32 and the container 10.

[0037] The radially elastic functional areas 44 and 50, designed with a narrow width B, provide a quasi-linear sealing area that is largely insensitive to geometric tolerances, surface damage and the like, thus enabling the container to be used in both overpressure and underpressure conditions.

[0038] As can be further seen from the Fig. 4 This results in a third functional surface 60 on the inside 40 of the neck part 20, a transition surface which opens into the container part 10 and, starting from the attachment functional surface 44, has an outwardly projecting transition cone 62. Looking towards the Fig. 4 Looking downwards, the transition cone 62 transitions into a cylindrical transition piece 64, which, within the framework of the transition arc 42 and as part of the neck section 20, merges seamlessly into the container section 10, which forms a receiving space within a predefinable cavity for the container contents 14. The transition piece 64 is designed as a circular or oval hollow cylinder on both its outer and inner circumferences.

[0039] In View towards the Fig. 4 As seen, a further fourth functional surface 66, adjacent to the further functional surface 50, is provided as a further transition cone 68 with an inclination direction opposite to that of the first transition cone 62, i.e., the further transition cone 68 widens upwards in the opposite direction. The inner circumference of this fourth functional surface 66 transitions towards the connected head section 18 or towards the released container opening 12 into a fifth functional surface 70, which has a locking feature for the extraction device 30 on its adjacent outer wall section 72 in the form of at least one threaded section 24 ( Fig. 1 , 2 and 3 ) and in Fig. 4 only shown schematically.

[0040] As in the view of Fig. 4 not visible, however in Fig. 2a As shown, the functional surface 44 and the additional front surface 50 are overlapped at their adjacent outer wall areas or outer wall sections 54, 56 by at least two webs 76, which at their free ends are integrally formed and transition into the adjacent outer wall areas in the form of the respective transition cone 62, 68 in the associated area of ​​the third and fourth functional surfaces 60 and 66, respectively. The webs 76 serve for axial stiffening as well as circumferential stiffening and are, as shown in Fig. 2 The elements are shown arranged diametrically opposite each other on the outside of the neck part 20, with respect to the longitudinal axis 34 of the container. For the sake of simplicity, the corresponding webs 76 are shown in the Fig. 1 omitted. Like the Fig. 3 As further shown, which depicts the container part 10 without container contents 14, additional stiffening webs 78 can be arranged on the outside of the container part 10 in a vertical plane with the webs 76. Via such webs 78, the respective container or ampoule is connected to other containers or ampoules of the same type in a row and in a common plane or orientation as a commercial product during manufacturing, prior to any separation (not shown), within the framework of a typical card assembly (not shown).

[0041] Another solution aims to provide a device for manufacturing a container according to the Fig. 1 bis 4 or to create a connecting device which, within the framework of a shaping plastic manufacturing process, uses a mandrel 80 which serves as a positive mold according to the illustration. Fig. 5 und 6 at least two different forming surfaces 82, 84 are formed, which, in the context of the forming process, later correspond in their design to the functional surface 44 and the adjoining functional surface 50, respectively. In particular, the forming mandrel 80 can be used in the manufacture of a container according to the design shown. Fig. 1 bis 4 within the framework of a standard blow molding, filling and closing process (BFS or bottelpack ®< process), which is described in more detail by way of example using a corresponding manufacturing device according to DE 10 2014 001 446 A1.

[0042] How in particular the Fig. 6As shown, the forming mandrel 80 is designed as a hollow mandrel and has the forming surface 82 on its underside, which later generates the 3.43-degree cone angle for the conical contact functional surface 44. Above this, the forming surface 82 is arranged on the outer circumference of the forming mandrel 80, forming a preferred cone angle of 30 degrees or a preferred 15-degree chamfer when viewed along the longitudinal axis 86 of the forming mandrel 80. Above the forming surface 84, further forming surfaces 88 are arranged one above the other as a third type of forming surface with different diameters, which serve to produce further functional surfaces 66, 70 in the neck part 20; optionally, they are also used for forming the head part 18.

[0043] The solution was explained in detail primarily using locking and non-locking conical connections according to ISO 803669-7:2016, but can also be applied in a simple and analogous way to delivery devices / delivery bodies of other geometries, such as those used for enteral (ISO 80369-3:2016) or neuraxal administration (ISO 80369-6:2016, which includes, among others, spinal or epidural anesthesia and intrathecal chemotherapy).

[0044] This solution provides a container or ampoule with a special connection device or other coupling mechanism that can be manufactured cost-effectively and reliably using a blow-fill-seal (BFS) process. With minimal handling forces or torques, the corresponding connections for fluid transfer, based on a standardized dispensing body, can be reliably manufactured to be both vacuum- and pressure-tight. Soft plastic materials such as polypropylene (PP) or polyethylene (HDPE, LDPE) can be readily used for the container.

Claims

1. Container, particularly an ampoule, consisting of plastics material, having a container part (10) for receiving a container content (14) that can be dispensed through a container opening (12), said ampoule being closed by a head part (18) that can be detached along a separation point (16), said head part abutting a neck part (20) that has four different functional surfaces on its inner circumferential side, a first contact functional surface (44) of said functional surfaces serving to provide a seal with respect to an extraction body (32), which is provided for extracting the container content (14) when the container opening (12) is released, wherein, in addition to the first contact functional surface (44), a front surface (50) is provided as a second functional surface on the inside (40) of the neck part, said front surface differing geometrically from the first contact functional surface (44), the front surface (50) transitioning seamlessly into the first contact functional surface (44), the front surface (50) and the first contact functional surface (44) being received in the neck part (20) between a third functional surface (60) and a fourth functional surface (66), characterised in that the first contact functional surface (44) and the front surface (50) are overlapped at their adjacent outer wall regions (54, 56) by at least two webs (76), which, at their free ends, each transition into the adjacent outer wall regions of the third and fourth functional surface (60, 66), the opening angle (α) of the front surface (50), which is configured in the form of a cone, measuring 10 to 40 degrees.

2. Container according to claim 1, characterised in that the differences in geometric properties between the first contact functional surface (44) and the front surface (50) relate to their - longitudinal extension and / or - wall thickness in connection with adjacent outer wall parts of the neck part and / or - surface inclination.

3. Container according to either claim 1 or claim 2, characterised in that at least part of the first contact functional surface (44) simultaneously exerts an increased sealing pressure on the received extraction body (32) with a reduced sealing surface.

4. Container according to any of the preceding claims, characterised in that a sealing action between the container 15 and an extraction body (32) introduced via the released container opening (12) is only achieved via the first contact functional surface (44) of the neck part (20) in that, in the extraction position of the extraction body (32) in the neck part (20), the first contact functional surface (44) at least partially comes into contact with the outer surface of the extraction body (32), forming a sealing surface.

5. Container according to any of the preceding claims, characterised in that, by incorporating the adjacent outer wall parts (54, 56) for the first contact functional surface (44) and those of the second functional surface (50), the average wall thickness in the region of the front surface (50) and / or the first contact functional surface (44) is reduced by approximately 20% to 50%, preferably approximately 20% to 30% compared with the average wall thickness of the other functional surfaces (66, 70).

6. Container according to any of the preceding claims, characterised in that the first contact functional surface (44) has a contact cone with an opening angle from 0 to 10 degrees, preferably 2 to 5 degrees, more preferably 3 to 4 degrees.

7. Container according to any of the preceding claims, characterised in that the opening angle (α) of the front surface (50) measures 20 to 40 degrees, preferably 25 to 35 degrees.

8. Container according to any of the preceding claims, characterised in that the distance (C) between the head end of a partial thread (26) and the container opening (12) is no more than 2 mm, preferably less than 1 mm.

9. Container according to any of the preceding claims, characterised in that the distance (D) between the head end of the first contact functional surface (44) and the container opening (12) is more than 3 mm, preferably more than 4 mm, more preferably more than 5 mm.

10. Container according to any of the preceding claims, characterised in that a transitional surface acts as a further third functional surface (60) on the inside of the neck part (20), said transitional surface opening into the container part (10) and having a transitional cone (62) originating from the first contact functional surface (44).

11. Container according to any of the preceding claims, characterised in that a further transitional cone (68) is provided as a further fourth functional surface (66) adjacent to the second functional surface, having an opposite direction of inclination to the one transitional cone (62).

12. Container according to any of the preceding claims, characterised in that, in the direction of the head part (18), the fourth functional surface (66) transitions into a fifth functional surface (70), which comprises a fixing option (74) for the extraction device (30) on its adjacent outer wall part (72).

13. Container according to any of the preceding claims, characterised in that a fixing option (74) on the outside of the neck part (20) for the extraction device (30) is formed by at least one threaded section (24) in the form of a screw-on thread and in that the threaded section (24) is preferably formed by at least two partial threaded portions (26, 28), the central thread profiles of which enclose an angle of approximately 70 to 80 degrees with the longitudinal axis (34) of the container.

14. Container according to any of the preceding claims, characterised in that it is used for packaging fluids for enteral applications.

15. Container according to any of the preceding claims, characterised in that it is used for packaging fluids for parenteral applications.

16. Container according to any of the preceding claims, characterised in that it is used for packaging fluids for neuraxial applications.