Medical container, and drug delivery device comprising the medical container

Abstract

To provide a medical container enabling reduction of the manufacturing costs while maintaining a highly reliable connection between the medical container and an element to be attached to the container.SOLUTION: The invention provides a medical container, and a drug delivery device comprising the medical container. The medical container (1) includes a tubular barrel (2) defining a reservoir for a medical product, and a longitudinal distal tip (4) defining a fluid path (40) in communication with the reservoir in order to allow the medical product to be expelled from the medical container (1). The distal tip (4) and the barrel (2) are made of glass. The distal tip (4) is provided with a thread (8). The thread (8) is configured to connect the distal tip (4) to a connecting element having a complementarily shaped internal thread.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to a medical container and a drug delivery device comprising said medical container. [Background technology]

[0002] In this application, the distal end of a component or device should be understood to mean the end furthest from the user's hand, and the proximal end should be understood to mean the end closest to the user's hand. Similarly, in this application, the "distal direction" should be understood to mean the injection direction with respect to the medical container or drug delivery device of the present invention, and the "proximal direction" should be understood to mean the direction opposite to said injection direction, i.e., the direction towards the user's hand holding the medical container or drug delivery device of the present invention, with respect to the injection operation.

[0003] Essentially, drug delivery devices, such as syringes, are preferably made of glass due to its high chemical passivity, its low gas permeability and high transparency, which allows for long-term storage and easy inspection.

[0004] A drug delivery device typically includes a container forming a reservoir for containing a medicament. The container has a distal end in the form of a longitudinal tip defining an axial passageway through which the medicament is expelled from the container. However, this longitudinal tip is not itself capable of parenteral administration and must be provided with either a staked needle or an adapter that allows connection of a syringe to a connector, such as a needle hub or an intravenous (IV) line.

[0005] It is important that the connection between the drug delivery device and the adapter is strong enough to prevent either accidental disengagement caused by fluid pressure within the drug delivery device or while connecting the connector to the drug delivery device.

[0006] Essentially, the adapter can be secured around the longitudinal tip of the syringe by mechanical attachment means defined in the longitudinal tip, such as, for example, a groove, by snap fit or friction. However, incorporating a groove in the longitudinal tip can make the longitudinal tip susceptible to cracking, which can lead to tip breakage. Additionally, an adapter connected around the longitudinal tip by a snap fit or friction can exhibit both limited resistance to torque and pull-out forces.

[0007] To improve resistance to torque and pull-out forces, it is further known from WO 2016 / 198580 to provide an adapter with an attachment ring shaped and configured such that when the adapter is attached around the longitudinal tip of the drug delivery device, an annular space is created between the attachment ring and the longitudinal tip. The annular space usually comprises an adhesive layer to efficiently bond the adapter to the longitudinal tip. Such an adapter provides resistance to high torque and pull-out forces. However, the step of adding an adhesive layer to this annular space involves increased manufacturing costs.

[0008] It is also known to provide the longitudinal tip with an external thread that engages with the internal thread of the adapter. If the drug delivery device is made of plastic, the distance between the external threads of the longitudinal tip is located as close as possible to the distal shoulder of the barrel. This avoids undercuts and limits the cost and the complexity of the injection process. Moreover, this makes it possible to reduce the length of the longitudinal tip without reducing the length of the connection between the external thread and the distal end, thereby limiting the material costs. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] International Publication No. 2016 / 198580 Summary of the Invention [Problem to be solved by the invention]

[0010] In this regard, it is an object of the present invention to provide a medical container that makes it possible to reduce manufacturing costs while maintaining a reliable connection between the medical container and the element to be attached to the container. [Means for solving the problem]

[0011] One aspect of the invention is a medical container comprising a tubular barrel defining a reservoir for a medicinal product and a longitudinal distal tip defining a fluid pathway in communication with the reservoir to allow the medicinal product to be expelled from the medical container, the distal tip and the barrel being made of glass, the distal tip being provided with a screw thread configured to connect the distal tip to a connecting element having a complementary shaped internal thread. The medical container comprises a distal shoulder connecting the barrel and the distal tip, the distance d1 between the shoulder and the proximal end of the screw thread being comprised between 1-5 mm, preferably between 2-4 mm.

[0012] The medical container of the present invention therefore allows a reliable connection between the distal tip and a connection element, such as an adapter, which is connected to the distal tip. The reliability of the connection relies on the distal tip being provided with an integrated thread, which is made of glass, as it is integrally formed with the distal end of the medical container. Thanks to this thread, the connection between the medical container and the additional element is more reliable than if it were connected by a frictional snap fit.

[0013] The reliability of the connection also depends on the distance d1 between the distal shoulder of the barrel and the thread. Having the glass thread away from the distal shoulder makes it possible to form the glass thread with high precision and ensure the proper shape, geometry and tolerances. Existing tips are provided with threads as close as possible to the distal shoulder of the barrel, but the present invention, contrary to all expectations, provides a more reliable connection by placing the glass thread away from this distal shoulder.

[0014] Furthermore, assembly of a medical container with an element such as an adapter only requires engaging the threads of the distal tip with the internal threads of the element, and therefore does not require additional steps such as providing an adhesive layer, making the connection less expensive than prior art.

[0015] In the present application, a connecting element is to be understood as any element intended to be attached to the distal tip by means of the thread of the distal tip. For example, the connecting element may be a cap or an adapter, such as a Luer lock adapter, that allows to secure the connection between the distal tip and an additional element.

[0016] Preferably, the outer diameter of the distal tip is comprised between 2 and 12 mm, preferably between 2 and 6 mm, even more preferably between 3 and 5 mm.

[0017] In this application, the outer diameter of the distal tip should be understood as the maximum outer diameter of said distal tip, not including the threads of the distal tip.

[0018] Preferably, the medical container comprises a distal end surface, the distance between said distal end surface and the distal end of the thread being comprised between 7 and 9 mm, preferably about 8 mm.

[0019] Preferably, the distal tip comprises a male connection portion configured to mate with a complementary female connection portion of the additional element, the threads being disposed proximally relative to the male connection portion.

[0020] In this application, an additional element should be understood as any element intended to be connected to the distal tip of the medical container to achieve a given function. For example, the additional element may be a needle hub, a cap, or a connector, an IV (intravenous), IM (intramuscular), or subcutaneous connector, that can be fixed to the distal tip by an adapter, such as a Luer lock adapter.

[0021] The distal tip may include a cylindrical and / or frusto-conical portion. Preferably, the distal tip includes a frusto-conical portion to allow for a luer slip or luer lock connection with an additional element. Thus, the male connection is preferably frusto-conical in shape.

[0022] In one embodiment, the distal tip comprises a cylindrical portion and the threads are disposed on said cylindrical portion of the distal tip. Advantageously, if the distal tip also includes a frusto-conical portion, the threads are disposed on the cylindrical portion of the distal tip, said cylindrical portion being disposed between the frusto-conical portion and the distal shoulder of the medical container.

[0023] This provides greater flexibility for the medical container, allowing it to work with existing adapters and / or connectors, which often have cylindrical internal threads.

[0024] Preferably, the threads on the distal tip are external male threads.

[0025] By external male threads it is meant that the threads of the distal tip protrude outwardly from the outer surface of the distal tip, rather than being formed by an inward recess into the outer surface.

[0026] Preferably, the pitch thread of the screw thread is comprised between 0.5 and 1.5 mm, preferably about 0.7 mm.

[0027] Preferably, the thread extends axially over a total length comprised between 1 and 5 mm, preferably between 1 and 4 mm.

[0028] Preferably, the thread has a triangular or trapezoidal shape, preferably a triangular shape.

[0029] Yet another aspect of the invention is a drug delivery device comprising a medical container as described above and a connecting element attached to a distal tip of the medical container, the connecting element having a first internal thread that engages with the threads of the distal tip.

[0030] Preferably, the connecting element is an adapter further comprising a second internal thread configured to engage with the thread of the additional element, the additional element being intended to be attached to the connection part of the distal tip, the second internal thread having a larger pitch thread than that of the thread of the distal tip.

[0031] Preferably, the threads on the distal tip are one of right-handed or left-handed threads, while the second internal threads of the adapter are the other of right-handed or left-handed threads.

[0032] Alternatively, the threads on the distal tip and the second internal threads of the adapter are both either right-handed or left-handed.

[0033] Advantageously, the connecting element is made of a plastic material.

[0034] The invention and advantages arising therefrom will become more apparent from the detailed description given below with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0035] [Figure 1] FIG. 1 is a partial perspective view of a medical container according to an embodiment of the present invention. [Diagram 2] FIG. 2 is a partial cross-sectional view of a medical container according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] With reference to Figure 1, a medical container 1 according to an embodiment of the present invention is shown. The medical container 1 comprises a tubular barrel 2 defining a reservoir 20 for a medicinal product, and a longitudinal distal tip 4 provided at a distal end of the tubular barrel 2, as shown in Figure 2. The distal tip 4 defines a fluid pathway 40 in communication with the reservoir 20 of the tubular barrel 2 to allow the medicinal product to be expelled from the medical container 1. The medical container 1 may include a distal shoulder 6 at the distal end of the tubular barrel 2, with the distal tip 4 protruding distally from the distal shoulder 6. Both the tubular barrel 2 and the distal tip 4 are made of glass.

[0037] The distal tip 4 includes a thread 8, which is also made of glass. The thread 8 is configured to connect the distal tip 4 of the medical container 1 to a connection element, such as an adapter 10 illustrated in FIG. 2, having a complementary shaped internal thread 100. Thus, the glass distal tip 4 has an integral glass thread 8, thereby enabling a reliable connection between the adapter 10 and the distal tip 4 of the medical container 1.

[0038] The threads 8 may be integrally formed with the distal tip 4, for example in a single operation. They may also be formed as a single piece with the barrel 2, which is preferably formed first.

[0039] The thread 8 is advantageously a male external thread protruding from the outer lateral surface 42 of the distal tip, rather than being formed by a recess provided on the inside of the outer lateral surface 42. This substantially limits the risk of breakage of the distal tip 4.

[0040] The thread 8 is preferably a helical thread. It may be right-handed or left-handed. Preferably, the thread 8 has a triangular or trapezoidal shape, preferably a triangular shape as illustrated in Figures 1 and 2.

[0041] The distal tip 4 has an outer diameter D that is smaller than the outer diameter of the tubular barrel 2. The outer diameter of the distal tip 4 is comprised between 2 and 12 mm, preferably between 2 and 6 mm, and even more preferably between 3 and 5 mm. For example, said outer diameter of the distal tip may be 4.4 mm.

[0042] 1 and 2, the distal tip 4 includes a male connection portion 44 configured to mate with a complementary female connection portion of an additional element (not shown), such as a connector. The threads 8 may be disposed on the male connection portion 44. However, as shown in FIG. 1 and 2, the threads 8 are preferably disposed proximally relative to the male connection portion 44.

[0043] The male connection portion 44 may be cylindrical or frusto-conical, as shown in Figures 1 and 2, with the distal tip 4 tapering in the distal direction.

[0044] Furthermore, the distal tip 4 may further include a cylindrical portion 46 arranged proximally to the male connecting portion 44, more precisely between the distal shoulder 6 and the male connecting portion 44, and the screw threads 8 are preferably arranged on said cylindrical portion 46.

[0045] The thread 8 of the distal tip 4 is advantageously arranged closer to the distal shoulder 6 than the distal end face 48 of the distal tip 4. For example, the distance d1 between said distal shoulder 6 and the proximal end 80 of the thread 8 is comprised between 1 and 5 mm, preferably between 2 and 4 mm. Furthermore, the distance d2 between said distal end face 48 and the distal end 82 of the thread 8 is advantageously comprised between 7 and 9 mm, preferably about 8 mm. The thread 8 may extend axially over a total length L, the distance between its proximal end 80 and its distal end 82 being comprised between 1 and 5 mm, preferably between 1 and 4 mm.

[0046] Preferably, the pitch thread of the screw thread 8 is comprised between 0.5 and 1.5 mm, preferably about 0.7 mm. The pitch thread can have a constant value.

[0047] It should be noted that the height of the thread 8 is comprised between 0.3 and 0.7 mm, preferably 0.5 mm. The height of the thread 8 is the distance between the crest of the thread and the root of the thread. This height is advantageously constant. As a result, if the thread 8 is arranged in a cylindrical portion of the distal tip 4, the thread 8 can therefore have a constant diameter. Thus, if the thread 8 is arranged in a frustoconical portion of the distal tip 4, the thread 8 may instead have a variable diameter, which decreases in the distal direction as the diameter of the frustoconical portion decreases.

[0048] The number of turns defined by the thread 8 may be comprised between 1 and 10, preferably between 1 and 5, and even more preferably between 1 and 3. For example, the number of turns defined by the thread 8 is 2. It is noted that the number of turns defined by the thread 8 is preferably greater than (and not equal to) 1.

[0049] With reference to Figure 2, the present invention also relates to a drug delivery device 3 comprising a medical container 1 as described above, thus having a glass distal tip 4 provided with a screw thread 8 and a connection element, e.g. an adapter 10, attached to the distal tip 4 of the medical container 1, the connection element having a first internal thread 100 which engages with the screw thread 8 of the distal tip 4. The medical container 1 may be a syringe and the drug delivery device 3 may be an injection device.

[0050] The connecting element can be an adapter 10, preferably made of a plastic material, more precisely any rigid polymer adapted for medical applications, such as high density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA) and combinations thereof. Preferably, the adapter 10 is made of polycarbonate (PC).

[0051] 2, the adapter 10 further comprises a second internal thread 102 configured to engage with the threads of an additional element (not shown), such as a connector, which is intended to be attached to the connection portion 44 of the distal tip 4. The second internal thread 102 may have a pitch thread larger than that of the threads 8 of the distal tip 4.

[0052] It is contemplated that the threads 8 of the distal tip 4 are one of right-handed or left-handed threads, whereas the second internal threads 102 of the adapter 10 are the other of right-handed or left-handed threads. Alternatively, the threads 8 of the distal tip 4 and the second internal threads 102 of the adapter 10 can both be either right-handed or left-handed threads.

[0053] 2, the adapter 10 may include a stopper 104 to ensure proper installation of the adapter 10. The stopper 104 may be in the form of an inner radial rim that defines a proximal shoulder. When the adapter 10 is properly installed, the threads 8 on the distal tip contact the stopper 104. The stopper 104 also prevents the adapter 10 from contacting the distal shoulder 6 of the barrel 2. As a result, the proximal end of the adapter 10 remains clear of the distal shoulder 6.

[0054] It is contemplated that the first internal thread 100 and the second internal thread 102 of the adapter 10 are separated by a distal shoulder 106. The first internal thread 100 is proximal to the distal shoulder 106 and the second internal thread 102 is distal to the distal shoulder 106. As a result, the first and second internal threads 100, 102 of the adapter 10 are axially offset in the longitudinal direction of the medical container 1. Furthermore, the second internal thread 102 of the adapter 10 and the outer surface of the connection portion 44 directly face each other without any sleeve of the adapter extending between them.

[0055] The method of manufacturing the medical container 1 can include forming the threads 8 and the distal tip 4, more specifically, forming the threads 8 and the connection 44 of the distal tip 4 in a single operation, for example by pressing the distal tip 4 between two forming wheels, such as two rotating forming wheels, which may be shaped to simultaneously form the threads 8 and the distal tip 4 including the connection 44. The forming wheels may have an outer surface provided with recesses configured to form the threads 8. This step can also be performed after the barrel 2 is formed.

Claims

1. A medical container (1) comprising a tubular barrel (2) defining a reservoir (20) for a medicinal product, and a longitudinal distal tip (4) defining a fluid path communicating with said reservoir (20) to allow said medicinal product to be expelled from said medical container (1), said distal tip (4) and said barrel (2) being made of glass, said distal tip (4) being provided with a screw thread (8) which is shaped to fit the distal tip (4) in a complementary manner. the medical container (1) is configured to be connected to a connection element (10) having an internal thread (100) of 1 mm, the medical container (1) comprising a distal shoulder (6) connecting the barrel (2) and the distal tip (4), a distance (d1) between the shoulder (6) and a proximal end (80) of the thread (8) being configured to be between 1 and 5 mm, and the thread (8) of the distal tip (4) being configured to be adjacent to a stopper (104) of the connection element (10).

2. The medical container (1) according to claim 1, wherein the outer diameter (D) of the distal tip (4) is comprised between 2 and 12 mm.

3. The medical container (1) according to claim 1 or 2, wherein the medical container (1) comprises a distal end face (48), and a distance (d2) between the distal end face (48) and the distal end (82) of the screw thread (8) is comprised between 7 and 9 mm.

4. The medical container (1) according to any one of claims 1 to 3, wherein the distal tip (4) comprises a male connection portion (44) configured to fit into a complementary female connection portion of an additional element, and the screw thread (8) is arranged proximally relative to this male connection portion (44).

5. 5. The medical container (1) according to claim 4, wherein the male connection portion (44) has a frusto-conical shape.

6. The medical container (1) according to any one of the preceding claims, wherein the distal tip (4) comprises a cylindrical portion (46) and the screw thread (8) is arranged on the cylindrical portion of the distal tip (4).

7. The medical container (1) according to any one of the preceding claims, wherein the thread (8) of the distal tip (4) is a male external thread.

8. The medical container (1) according to any one of the preceding claims, wherein the pitch thread of the screw thread (8) is comprised between 0.5 and 1.5 mm.

9. The medical container (1) according to any one of the preceding claims, wherein said thread (8) extends axially over a total length (L) comprised between 1 and 5 mm.

10. The medical container (1) according to any one of the preceding claims, wherein the thread (8) has a triangular or trapezoidal shape.

11. A drug delivery device (3) comprising a medical container (1) according to any one of claims 1 to 10 and a connection element (10) attached to a distal tip (4) of the medical container (1), the connection element (10) having a first internal thread (100) which engages with the thread (8) of the distal tip (4).

12. The drug delivery device (3) of claim 11, wherein the connecting element (10) is an adapter further including a second internal thread (102) configured to engage with the threads of an additional element, the second internal thread (102) having a pitch thread larger than that of the threads (8) of the distal tip (4).

13. 13. The drug delivery device (3) of claim 12, wherein the thread (8) of the distal tip (4) is one of a right-handed thread or a left-handed thread, whereas the second internal thread (102) of the adapter is the other of a right-handed thread or a left-handed thread.

14. The drug delivery device (3) according to claim 12, wherein both the thread (8) of the distal tip (4) and the second internal thread (102) of the adapter are either right-handed or left-handed.

Images