Cap for closing a container for drug management and method for manufacturing the same

Abstract

The present invention relates to a cap for closing a container for administering medicines, comprising a pot-shaped body having a cavity with at least one or more openings and a base surface delimiting the cavity in at least some areas, and at least one septum, the body having a dome with an end opening closed by the septum, the dome (26) protruding from the base surface on the side opposite said cavity (24). The septum is inserted under pretension into the receiving space of the dome. The present invention also relates to a method for manufacturing the cap.

Description

Technical Field

[0001] The present application relates to a cap for closing a container for drug management and a method for manufacturing the same.

Background Art

[0002] Caps for closing drug containers such as infusion bottles and infusion bags are restricted in many safety aspects from both the viewpoints of airtightness against drug outflow and prevention of intrusion of external media. Therefore, in the context of further development, various design aspects often need to be considered.

[0003] The closure of a drug container is known from European Published Patent Application No. 2 376 341, which has a receiving portion directed inward from the base region of the cap at an interval from the cap wall in order to mechanically separate the deformation force applied to the outer wall. The outer wall of the cap protects the receiving portion and its surroundings from external mechanical action. At the same time, the partition wall is held under prestress within the cap.

[0004] The disadvantages such as internal undercuts and annular gaps in the product contact area of the closure system are that as long as the cap is arranged with the partition wall downwards, the product is not retained here and is not delivered to the patient.

[0005] In another variant of the prior art, the dead volume is constructed by the partition wall shape of the partition wall. Depending on how the partition wall is inserted and fixed to the main body of the cap, the shape of the partition wall may be significantly different from others. In German Published Patent Application No. 10 2017 000 048, FIGS. 7 and 8 show a general variant of the partition wall cap, which has a circumferential annular groove 39 on the side opposite to the puncture side.

[0006] This annular groove represents a dead volume that can collect fluid not delivered to the patient. In a further variant of FIGS. 9a and 9b, the partition wall has a thick protruding configuration. Again, due to the configuration, there is a dead volume in the bottom region between the puncture side and the edge of the cap. However, the shape of the partition wall in this specification aims to ensure the airtightness of the cap and minimize the dead volume.

[0007] German Published Patent Application No. 10 2008 060 457 discloses a variant of the cap in which the partition wall is welded to the body of the cap without pre-tension. However, since the partition wall is attached without pre-tension, the holding force and sealing force applied to a liquid transfer device such as a puncture component are low. The puncture component is preferably pin-shaped or spike-shaped. It is necessary to increase the sealing force and the holding force.

[0008] As is known from German Published Patent Application No. 10 2017 000 048, an increase in the sealing force associated with an increase in the radial pre-tension also disadvantageously leads to an increase in the puncture force of the puncture component. The radial pre-tension of the partition wall during assembly within the cap needs to be selected such that, on the one hand, the sealing function and the holding function are improved, and on the other hand, the puncture length, and thus the puncture resistance, can be reduced so as to reduce the puncture force. The features mentioned in the main claim also make it possible to achieve material and cost savings in the manufacture of the partition wall.

[0009] The airtightness between the cap and the partition wall can be achieved in different ways together with the partition wall. In German Published Patent Application No. 198 18 314, the airtightness of the partition wall with respect to the cap is mainly achieved by clamping the partition wall in the cap via the clip part 26.

[0010] German Published Patent Application No. 10 2016 003 253 of the same genus shows a modified example of a partition wall with a seal lip 16 extending around the edge, and the partition wall merges centrally within the seal surface. In the modified example shown in FIG. 3b, this seal surface has a flat contour. However, in order to ensure sufficient pre-tension for proper sealing, the seal lip 16 is solid and protrudes visibly from the receiving space.

[0011] Accordingly, as seen in FIG. 2, the dead volume is formed in the intermediate space or dead space between the partition walls and between each partition wall and the cap wall. The formation of the dead volume or dead space is reduced compared to other partition walls of German Published Patent Application No. 10 2016 003 253, but it cannot be completely prevented. This is required because the partition walls are held in the cap in a friction-fixed form without closure by additional materials such as joining or welding. SUMMARY OF THE INVENTION PROBLEM TO BE SOLVED BY THE INVENTION

[0012] Based on this prior art, the object of the present invention is now to maintain the partition walls in a pre-tensioned state while avoiding product retention undercuts and annular gaps in the cap body as much as possible. MEANS FOR SOLVING THE PROBLEM

[0013] The present invention solves this problem by a cap having the features of claim 1 and a method having the features of claim 18.

[0014] The cap of the present invention for closing a container for drug administration comprises a pot-shaped body having a cavity with at least one or more openings and a base surface partitioning the cavity in at least some regions. The cavity can have openings, particularly on both sides of a lateral surface, for example a conical lateral surface, on the one hand enabling access to the drug into the cavity and on the other hand enabling access to the injection needle into the cavity after piercing the partition wall. An opening can be provided at the lower part of the cap.

[0015] The main body also has a dome having an opening at an end face blocked by a diaphragm, and the dome protrudes from the base surface on the base surface side opposite to the cavity. The opening in the bottom region of the cap merges into another cavity within the dome. This cavity is closed to the outside by a partition wall. In the present invention, although protection against deformation forces acting from the outside is not provided, the dome is exposed to these deformation forces.

[0016] However, since the application area of the dome is very small, the probability of deformation in this region is relatively low. At the same time, however, the dosage of the infusion bag is more accurate, especially in the case of overhead infusion with the infusion bag suspended, because there is no undercut provided in the cap where the drug remains. Furthermore, the cap can optionally also be used for multiple applications.

[0017] The partition wall is inserted into the receiving space of the dome under prestress. Thereby, even after single or particularly multiple perforations by a needle, cannula, or other elements, the partition wall can be firmly closed.

[0018] This prestress can be further increased by some configuration variations, thereby making the prestress very large so that the tightness of the partition wall is not affected even by the deformation of the outer wall of the dome.

[0019] The corresponding advantageous design of the invention, particularly the constructive design, is the subject matter of the dependent claims.

[0020] It is advantageous if the partition wall has an oversize of at least 2.5%, preferably 3% to 10%, with respect to the first inner surface of the radial periphery of the receiving space. A partition wall with a thick material thickness usually cannot cope with this degree of interference fit. Therefore, it is advantageous if the axial extent of the region where the partition wall has a closed surface crossing the width of the dome extends over less than 70% of the height of the dome.

[0021] When the first inner surface has a path that is conical and has a deviation of 3° to 10° compared to a path parallel to the inner surface with respect to the dome central axis B, it is even more advantageous for the accumulation of the pre-tensioning force. This further enhances the holding effect of the partition wall, enabling a higher sealing force over the entire height of the partition wall compared to a partition wall having a cylindrical basic shape. The pre-tensioned partition wall accumulates a tension level equal to an approximately equal sealing force over the entire height of the receiving part.

[0022] Furthermore, the thickness of the partition wall can be reduced, and the length of the puncture into the partition wall can also be shortened. This means that the required insertion force is reduced and the peeling of the material during insertion is decreased.

[0023] For example, a materially bonded connection such as a welded connection or an adhesive connection, when arranged between the partition wall and the body, is particularly preferred for clamping. This materially bonded connection can particularly preferably be configured as a welded connection, and a welded connection extending radially around the dome central axis B is particularly preferred. In addition to the positive and non-positive connections of the partition wall and the dome by pre-tensioning, this welded connection forms a second safety measure, namely a so-called "second line of defense" against drug outflow and medium intrusion.

[0024] The welded connection is particularly preferably arranged such that when punctured, a radial tension acts on the partition wall. This is advantageous because the displacement of the material occurring in a thick partition wall is compensated by the movement of the tension. Such a radial tension occurs particularly when the partition wall is axially welded to the body with respect to the partition wall's own partition central axis or the longitudinal axis of the partition wall.

[0025] The partition wall can be made of a thermoplastic elastomer, which can particularly be welded and is particularly suitable for constructing the pre-tensioning due to its elastic properties. The individual parts of the partition, for example the individual layers, can also be made of different materials, but at least the contact surfaces on the dome where welding takes place should preferably be made of a TPE material. However, particularly preferably, the entire partition can also be made of TPE.

[0026] The cap may have an inner surface of a second radial peripheral portion for defining a receiving space having an average diameter smaller than the inner surface of the first radial peripheral portion. Here too, there may be a pre-tension between the body and the partition. It is advantageous if the partition has a smaller oversize with respect to the inner surface of the second radial peripheral portion compared to the sealing surface of the first radial peripheral portion.

[0027] Instead of or in addition to this, the inner surface of the second radial peripheral portion may deviate from a path parallel to the dome central axis by a larger angle than the inner surface of the first radial peripheral portion.

[0028] In particular, the partition can have a pre-tension gradient along the central axis of the dome, which preferably increases in the insertion direction. This means that after the needle is removed, no opening depression remains in the partition.

[0029] The materially bonded connection is preferably arranged between the first inner surface of the radial peripheral portion and the second inner surface of the radial peripheral portion. As a result, the fixing points of the partition of the cap are located between two substantially equivalent pre-tension operating regions.

[0030] As is known in the prior art, the cylindrical contour of the pedestal of the partition, or the cylindrical contour of the region where the partition abuts the cap with an oversize, shows a decrease in pre-tension along the path of the wall depending on the length of the lever, which is the reason why a very thick partition has to be used. This is particularly disadvantageous due to the consumption of material and the increase in the force required to apply the puncture.

[0031] Due to the optimal positioning of the conical contour and / or the fixing point in the form of a weld or joint between two equally short lever arms, a better force distribution of the pre-tension in the sealing area can be achieved, thus enabling a better sealing effect. Therefore, next, the thickness of the partition wall can be minimized simultaneously.

[0032] The cap preferably has two domes with the same contour. This results in a significant material saving, especially as the thickness of the partition wall is reduced and the sealing effect is improved simultaneously.

[0033] Advantageously, the partition wall can have a closed sealing surface extending across the width of the partition wall. The radial peripheral web protruding from this closed sealing surface forms part of the outer surface of the radial periphery of the partition wall that is not mechanically separated from the outer wall of the cap but is in contact with the inner surface of the dome, unlike in European Patent Publication No. 2 376 341. In this way, the web is positioned against the side wall of the dome and functions as a spring arm for constructing an axial restoring force in the case of axial deformation of the partition wall. However, the deformation of the wall of the dome is also directly related to the deformation of the web.

[0034] The body can be made of a thermoplastic material, preferably PP or PE, particularly HDPE.

[0035] Furthermore, a method for manufacturing a cap according to the present invention, A providing a body, particularly a body according to one of the preceding claims; B inserting the partition wall into the body, particularly applying contact pressure; C forming a materially bonded connection between the partition wall and the body, particularly including the step of maintaining contact pressure at least partially.

[0036] Thereby, a cap with a seal by pre-tension and a materially bonded connection is realized. The materially bonded connection reliably seals the lateral discharge of the drug, and in addition to the seal at the edge, the pre-tension also contributes to the re-sealing of the partition wall after penetration.

Brief Description of the Drawings

[0037] Hereinafter, a modification of an embodiment of the cap according to the present invention will be described in detail.

Figure 1

Figure 2

Modes for Carrying Out the Invention

[0038] FIG. 1 and FIG. 2 show a cap 1 for closing a container (not shown in more detail), such as an infusion bottle or an infusion bag. The cap 1 preferably has a body 25 made of a first thermoplastic material, particularly polypropylene - PP and / or polyethylene - PE, particularly HDPE.

[0039] The body 25 has a substantially dimensionally stable configuration. The body 25 has a pot-shaped basic shape typical of this outer shape with an open cavity 24. An opening 27 is provided for inserting or fitting the cap onto a corresponding container, such as a bottle or a bag. This cavity 24 is bounded by a conical first wall segment 6 that defines the central axis A of the cap. The conical deviation of the wall segment from the cylindrical shape is less than 5°, preferably from 1° to 3°. This enables the contact pressure against the container.

[0040] The conical first wall segment 6 terminates at a base surface 4 with a base plate 5. Depending on the shape of the corresponding object on the container corresponding to the cap 1, the base surface 4 is defined by the base plate 5 and forms a closing surface against the container. However, the base plate 5 does not necessarily have to be arranged perpendicular to the wall segment 6. The wall segment 6 joins the base plate 5 via its peripheral edge, bend or edge such that at least this peripheral edge, bend or edge is located on the base surface 4, thereby defining the position of the base surface 4. In other words, in the circumferential direction, preferably the circumferential direction, the line formed by the vertices of the edge can have a bend or rounding that is half the wall thickness of the edge and is located on the base surface 4.

[0041] Starting from the base surface 4, the cavity 24 of the cap has no protrusions or undercuts in the inner direction of the cap, so that, for example, no deposits are formed when components of a drug that may typically be present in liquid form crystallize.

[0042] Starting from the base surface 4, the body 25 has a receiving geometry for two partitions 2 above the cavity 24 bounded by the first wall segment 6. The transition from the base plate 5 to the receiving geometry is stepped. The partitions are made of a second material that is less rigid than the body 25, and the partitions can be penetrated by means of conventional medical technology. The material is particularly preferably TPE, i.e. thermoplastic elastomer.

[0043] In FIG. 1, the receiving geometry of the body 25 comprises two domes 26 connected to each other by a web 9, and the web 9 protrudes from the base plate 5 or the side surface of the base plate 5 opposite the cavity 24. The web 9 has a recess in the form of a channel 23. It is understood that in a variant of the invention only one dome may be formed.

[0044] Each dome 26 defines its respective dome central axis B and delimits a receiving space 20 for each partition 2, where the receiving space 20 is open on both axial sides with respect to the dome central axis B.

[0045] The first opening 15 of the receiving space 20 represents the transition to the cavity 24, while the second opening 17 is closed by the partition wall 2. As can be seen in FIG. 1, the sum of the average diameters of both receiving spaces of the dome 26 is smaller than the average diameter of the cavity 24.

[0046] Also, each dome 26 has a first inner surface 16 that is conical in the radial circumferential direction defining a receiving space for receiving the partition wall 2. The circumferentially conical inner surface 16 defines an average diameter as the average of all diameters across the contact area between the partition wall and the inner surface.

[0047] In contrast, each partition wall 2 has an oversize of at least 2.5%, preferably 3% - 10% in the contact area with this first inner surface 16. The oversize is shown in FIG. 1 using reference numeral 3. In particular, the partition wall 2 has a first outer surface 13 that is circumferential in the radial direction defining an average diameter. The diameter difference between the outer surface 13 of the partition wall 2 and the inner surface 16 of the dome 26 in the separated state defines the above oversize 3, and the average diameter of the outer surface 13 of the partition wall 2 in the separated state is at least 2.5% larger than the diameter of the inner surface 16 of the dome 26.

[0048] In this case, the inner surface 16 constitutes the largest contact area between the partition wall 2 and the dome 26. The second opening 17 defines a sealing surface 50. Along this sealing surface 50, leakage of the drug is prevented.

[0049] The dome 26 includes a stepped transition portion 7 having a second inner surface 11 that is conical in the radial circumferential direction and terminates at the opening 17. In contrast, the outer surface 12 of each partition wall 2 in the region contacting this second inner surface 11 has an oversize 18 of at least 2.5%, preferably 3% - 10%, and this oversize 18 refers to the disassembled state of the partition wall 2.

[0050] The second inner surface 11 that is conical in the radial circumferential direction has a greater conicity, i.e., a greater deviation from a parallel cylindrical path, than the first inner surface 16 that is conical in the radial circumferential direction. The oversizing is preferably smaller than the oversizing of the region of the first inner surface 16, so that a stepped prestress occurs over the path of the dome central axis. This enables an initial displacement of the material of the partition wall 2 to the outside in the puncture region, while at the same time a sealing effect can be achieved in this region.

[0051] The stepped transition portion 7 of the dome 26 comprises a surface segment 10 that extends essentially parallel to the sealing surface 50. The surface segment 10 can also have an oblique, in particular conical, path. This surface segment 10 has a materially bonded connection between the dome 26 and the partition wall 2.

[0052] The materially bonded connection in the surface segment 10 is preferably a welded connection. The welded connection can be produced by laser welding, where the laser beam can be directed towards the outer surface of the cap 1 that forms the sealing surface 50, in particular the end face 8 of the cap 1, which has advantages in terms of manufacturing and the sealing effect.

[0053] In the region of the surface segment 10, the partition wall is in contact with the inner surface of the dome 26 in a substantially stress-free state. This reduces the material stress during welding, enhances the sealing effect, and prevents separation of the materials.

[0054] The partition wall 2 has a closed sealing surface 19 that faces the cavity 24 and extends across the width of the partition wall. A radially peripheral web 14 projects from this sealing surface 19 and forms a part of the radially peripheral outer surface of the partition wall 2 that contacts the inner surface 16 of the dome. As can be directly seen from FIG. 1, the sealing surface 19 in the region between the radially peripheral webs 14 has a flat path, in particular a dedicated flat path.

[0055] Also, FIG. 1 shows that the width of the flat path of this sealing surface 19 substantially occupies more than 50% of the total width of the partition wall 2. As can be further seen from FIG. 1, the web 14 is placed against the inner surface 16 of the dome 26 and lies in the same plane as the receiving space 20 of the dome 26.

[0056] The dome 26 projects from the base plate 5, and the receiving space 20 of the dome 26 extends to the inner surface of the base plate 5 facing the cavity 24, as shown in FIG. 1.

[0057] This web 14 enhances the sealing effect of the partition wall 2 in the edge region, enables the construction of a high pre-tension, and the free space between the opposing segments of the web 14 can also be used for the movement of the material, for example, when a needle is inserted into the partition wall. At the same time, the segments of the web 14 function as spring arms when the partition wall 2 is deformed axially, for example, when a larger needle is inserted into the partition wall. As a result, an axial restoring force is formed, and when the cannula is removed, in addition to the radial pre-tension, the axial element acts to close the puncture side.

[0058] It is desirable for the web 14 to have a height such that the average radial width of the outer surface of the partition wall 2 in contact with the inner surface 16 of the dome 26 is less than 50%, preferably less than 35%.

[0059] The conicity of the second inner surface 16 of the dome 26 is also smaller than that of the first inner surface 11. As a result, during puncture, a different, particularly lower pre-tension is built in the upper region of the partition wall 2 than in the lower region, where "upper" and "lower" here refer to the direction of the puncture E and the position of the sealing surface 50 where the puncture is performed.

[0060] Although not shown in FIG. 1, the web 9 between both partition walls 2 is connected to the base plate 5 in the plane of the figure. Overall, the top view of the cap in the puncture direction shows that the basic shape of the overall geometry of the receiving part including the dome 26 is elliptical.

[0061] The cap 1 shown in Fig. 1 is idealized. Here, the sealing surface 50 is defined by the opening edge of the opening 17. In reality, the partition end face, which is essentially perpendicular to the puncture direction, may be slightly curved with respect to the sealing surface due to the prestress.

[0062] Still another part of the present invention is the method for manufacturing the aforementioned cap 1. This method includes a first step in which the body 25 is provided. This body 25 can be manufactured, for example, by an injection molding process or by another suitable plastic processing method.

[0063] In the second step of this method, the partition 2 can be inserted into the receiving space 20 of the dome 26 of the body 25. The partition can be inserted by applying a contact pressure to the partition.

[0064] This contact pressure is at least partially maintained in a later step to create a materially bonded connection between each partition 2 and the body 25. The materially bonded connection is preferably made at the surface segment 10 by a welding connection. This can be achieved by laser welding.

[0065] Next, the partition or the sealing surface can be coated with a coating element 22, for example, plastic, aluminum foil, or a molded plastic body that can be part of the cap. This can be seen, for example, in the top view of Fig. 2. Thereafter, the cap is packaged under aseptic conditions.

Explanation of reference numerals

[0066] 1 Cap 2 Partition 3 Oversize 4 Base surface 5 Base plate 6 Wall segment 7 Step transition 8 End face of the cap 9 Web 10 Surface segment 11 The conical second inner surface 12 The conical second outer surface of the partition wall 13 The conical first outer surface of the partition wall 14 The peripheral web 15 The first opening 16 The first conical inner surface 17 The second opening 18 Oversize 19 The sealing surface 20 The receiving space 21 The annular web 22 The cover element 23 The channel 24 The cavity 25 The body 26 The dome 27 The opening 50 The sealing surface A The longitudinal axis of the cap B The dome central axis E The puncture direction

Claims

1. A cap (1) for closing a container for drug management, comprising a pot-shaped body (25) having a cavity (24) with at least one or more openings (15, 27) and a base surface (4) delimiting the cavity (24) in at least some regions, and at least one partition (2), wherein the body (25) has a dome (26) with an opening (17) at the end face closed by the partition (2), the dome (26) protruding from the base surface (4) on the side of the base surface (4) opposite to the cavity (24), and the partition (2) being inserted into the receiving space (20) of the dome (26) under pre-tension in the cap (1), a connection portion materially adhered between the partition (2) and the body (25) is arranged, the materially adhered connection portion is arranged at a stepped transition portion (7) between a first inner surface and a second inner surface (11 and 16) of the radially peripheral portion of the dome (26), the partition (2) having a closed sealing surface (19) extending across the width of the partition (2), and a web (14) protruding from the sealing surface (19) at the radially peripheral portion, the web (14) forming a part of the outer surface (13) of the radially peripheral portion of the partition (2) in contact with the first inner surface (16) of the dome (26), the sealing surface (19) has a flat profile in the region between the webs (14) at the radially peripheral portion, the opening (17) at the end face defines the sealing surface, and the stepped transition portion (7) of the dome (26) includes a surface segment (10) extending substantially parallel to the sealing surface (50) of the partition, A cap characterized in that a segment of the web (14) is configured as a spring arm for applying a restoring force when the partition is axially deformed.

2. The cap according to claim 1, wherein the web (14) has an axial height less than 50% of the average radial width of the outer surface of the partition (2) in contact with the inner surface (16) of the dome (26).

3. The cap according to claim 1 or 2, wherein the dome (26) protrudes with respect to the base plate (5), and the receiving space (20) of the dome (26) extends to face the cavity (24) up to the inner surface of the base plate (5).

4. The cap according to any one of claims 1 to 3, wherein the web (14) abuts against the inner surface (16) of the dome (26) and is in the same plane as the receiving space (20).

5. The cap according to any one of claims 1 to 4, wherein the substantially adhesively bonded connection portion is a welded connection portion extending radially about the dome central axis (B).

6. The cap according to claim 5, wherein the welded connection portion is positioned such that when punctured, a radial tension acts on the partition wall (2).

7. The cap according to any one of claims 1 to 6, wherein the partition wall (2) is positioned against the inner surface of the dome (26) in the region of the surface segment (10) with a prestress.

8. The cap according to any one of claims 1 to 7, wherein the partition wall (2) has an oversizing (3) of at least 2.5% with respect to the first inner surface (16) of the radial peripheral portion of the receiving space (20).

9. The cap according to any one of claims 1 to 8, wherein the first inner surface (16) of the radial peripheral portion of the dome (26) has a conical path offset by 3° to 10° with respect to a path parallel to the inner surface with respect to the dome central axis (B).

10. The cap according to any one of claims 1 to 9, wherein the partition wall (2) is made of a thermoplastic elastomer.

11. The cap according to any one of claims 1 to 10, wherein the cap (1) has a second inner surface (11) of the radial peripheral portion of the dome (26) to define a receiving space (20) having an average diameter smaller than the first inner surface (16) of the radial peripheral portion.

12. The cap according to any one of claims 1 to 10, wherein the partition wall (2) has an oversizing smaller with respect to the second inner surface (11) of the radial peripheral portion of the dome (26) than with respect to the first inner surface (16) of the radial peripheral portion of the dome (26).

13. The cap according to any one of claims 1 to 12, wherein the cap (1) has two domes (16) having the same contour.

14. The cap according to any one of claims 1 to 13, wherein the cap (1) has two partition walls (2) having the same contour.

15. The cap according to any one of claims 1 to 14, wherein the second inner surface (11) of the radial peripheral portion of the dome (26) deviates from a path parallel to the dome central axis by a greater angle than the first inner surface (16) of the radial peripheral portion of the dome (26).

16. The cap according to any one of claims 1 to 15, wherein the partition wall (2) has a prestress gradient along the dome central axis (B).

17. The cap according to any one of claims 1 to 16, wherein the body (25) is made of a thermoplastic material containing PP or PE.

18. The cap according to any one of claims 1 to 17, wherein the surface defined by the base plate (5) of the cavity (24) of the cap (1) has no protrusions or undercuts to prevent the adhesion when the components of the drug crystallize.

19. A method for manufacturing the cap (1) according to any one of claims 1 to 18, comprising: A providing a body (25) according to any one of claims 1 to 18; B applying a contact pressure to insert the partition wall (2) into the body (25); and C forming a connection part materially bonded between the partition wall (2) and the body (25).

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