System Comprising a Drug Delivery Device and a Cartridge Provided with a Bung and a Method of Identifying the Cartridge

Abstract

A system comprising a drug delivery device and a cartridge provided with a bung and and a method of identifying the cartridge

The present invention relates to a bung (20), to a drug containing cartridge (10) and to a drug delivery device, wherein the bung (20) comprises a coding feature (28) for carrying information regarding at least one of the cartridge (10) and the content of the cartridge (10). Furthermore, it relates to a method for identifying a cartridge (10) containing a medicinal product.

Claims

1-18. (canceled)

19. A bung for a drug containing cartridge, wherein the bung comprises an electronic coding feature for carrying information regarding at least one of the cartridge and the content of the cartridge, wherein the electronic coding feature is located inside the bung.

20. The bung according to claim 19, wherein the electronic coding feature comprises a transponder.

21. The bung according to claim 20, wherein the transponder is a RFID-member.

22. The bung according to claim 20, wherein the transponder is a passive transponder.

23. The bung according to claim 20, wherein the transponder is an active transponder.

24. The bung according to claim 23, wherein the active transponder comprises one or more integrated sensors.

25. The bung according to claim 19, wherein the electronic coding feature is surrounded by an electrically isolating material.

26. The bung according to claim 19, wherein the electronic coding feature is surrounded by a polymer-matrix.

27. The bung according to claim 19, wherein the bung comprises a first material covering at least the whole lateral area of the bung and a second material at least partially arranged inside the bung, wherein the second material has a smaller compressibility than the first material.

28. The bung according to claim 27, wherein the first material covers the whole surface of the bung.

29. The bung according to claim 27, wherein the first material comprises a polymer and the second material comprises a polymer.

30. A cartridge comprising a bung according to claim 19.

31. The cartridge according to claim 30, wherein the cartridge contains a medicinal product.

32. The cartridge according to claim 30, wherein the bung is moveable along a longitudinal axis of the cartridge.

33. A drug delivery device comprising a cartridge according to claim 30.

34. The drug delivery device according to claim 33, wherein the drug delivery device comprises means to interact with the electronic coding feature, such as an electromagnetic sensing device.

35. A system comprising a drug delivery device according to claim 33 and external means arranged outside of the drug delivery device, wherein the external means are able to interact with the electronic coding feature.

36. A method of identifying a cartridge according to claim 30, wherein the cartridge contains a medicinal product and the bung is located inside the cartridge, wherein the electronic coding feature is carrying information regarding at least one of the cartridge and the content of the cartridge, and wherein the method comprises the use of the information to distinguish the cartridge and the content of the cartridge within a batch of other cartridges.

37. A method of manufacturing a bung according to claim 19, wherein the bung is manufactured by injection molding.

38. A method of manufacturing a bung according to claim 29, wherein the method comprises the steps of: (i) forming a shell comprising the first material by injection molding; (ii) adding monomers and the electronic coding feature inside the shell; and (iii) polymerising the monomers to form the second material.

Description

[0147] In the following the invention is described in further detail with references to the drawings, wherein

[0148] FIG. 1 shows a cross sectional view of a cartridge comprising a bung.

[0149] FIG. 2 shows a cross sectional view of a bung according to the present disclosure having a mechanical coding feature at the proximal end.

[0150] FIG. 3 shows a cross sectional view of a bung having an electronic coding feature.

[0151] FIG. 4a shows external means which interact with an electronic coding feature which the bung of a cartridge comprises.

[0152] FIG. 4b shows internal means of a drug delivery device which interact with an electronic coding feature which the bung of a cartridge comprises.

[0153] FIG. 5 shows a view onto a proximal end face of an embodiment of a bung carrying a protruding ring.

[0154] FIG. 6 shows a view onto a proximal end face of a further embodiment of a bung carrying a protruding ring.

[0155] FIG. 7 shows a cross-sectional view of an arrangement of a mechanical coding feature of a bung and a counterpart of the mechanical coding feature.

[0156] FIG. 8 shows a cross-sectional view of an arrangement of a further embodiment of a mechanical coding feature of a bung and a counterpart of the further mechanical coding feature.

[0157] FIG. 9 shows a cross-sectional view of an arrangement of a mechanical coding feature of a bung according to FIG. 7 and a counterpart of a mechanical coding feature according to FIG. 8.

[0158] FIG. 10 shows a cross-sectional view of an arrangement of a mechanical coding feature of a bung according to FIG. 8 and a counterpart of a mechanical coding feature according to FIG. 7.

[0159] FIG. 11 shows a view onto a proximal end face of an embodiment of a bung carrying a plurality of relief structures.

[0160] FIG. 12 shows a view onto a proximal end face of a further embodiment of a bung carrying a plurality of relief structures.

[0161] FIG. 13 shows a view onto a proximal end face of a further embodiment of

[0162] FIG. 14 shows a view onto a proximal end face of a further embodiment of a bung carrying a plurality of relief structures.

[0163] Some preferred embodiments of a bung according to the present invention will now be discussed with reference to FIG. 1, FIG. 2 and FIG. 3. Identical reference signs denote identical or comparable components.

[0164] FIG. 1 shows a cartridge 10. The cartridge 10 comprises a distal end 14, a main body portion 18, a proximal end 12 and a narrowing shoulder portion 16. At the proximal end of the cartridge a bung 20 is shown. This bung 20 has a distal end face 22, a proximal end face 24 and a lateral area 26. The lateral area 26 of the bung 20 forms a fluid-proof sealing by contacting the main body portion 18 of the cartridge 10.

[0165] The bung 20 is moveable with respect to the cartridge 10. A piston which is not shown can apply a force F to the bung 20 and move the bung 20 towards the distal end 14 of the cartridge 10 and dispense the liquid medicinal product. While the piston is adding pressure to the bung 20, the bung 20 is compressed. This compression together with the relaxation of the bung 20 after the compression directs to an inaccuracy of the dosage dispensed from the cartridge 10, wherein dosage means a certain volume of a liquid medicinal product.

[0166] FIG. 2 shows a cartridge 10, wherein the bung 20 comprises two different materials and a mechanical coding feature 28 located at the proximal end face 24 of the bung 20. The bung comprises a first material 40, covering the distal end face 22 and the lateral area 26 of the bung 20. The core of the bung 20 comprises a second material 42. This second material 42 has a smaller compressibility than the first material 40.

[0167] The first material 40 seals the content of the cartridge 10 by being pressed against the inner wall of the main body portion 18. Therefore the bung forms a fluid-proof closure between the lateral area 26 of the bung 20 and the main body portion 18 of the cartridge 10. The second material 42 stabilizes the bung 20 by providing a rigid core.

[0168] The mechanical coding feature 28 is attached to the core at the proximal end of this core.

[0169] If one wants to mount the cartridge 10 according to FIG. 2 to a drug delivery device, it is necessary that the mechanical coding feature 28 at the proximal end face 24 of the bung 20 matches to the appropriate counterpart 29 in the drug delivery device. The mechanical coding feature 28 is positioned at the proximal end face 24 of the bung 20.

[0170] When a cartridge 10 is mounted to a drug delivery device and the mechanical coding feature 28 fits to the counterpart 29 in the drug delivery device the user is enabled to dispense a liquid medicinal product from the cartridge 10. After dialing a dose of the medicinal product the bung 20 is pushed towards the distal end 14 of the cartridge 10 by means of a piston, which applies a force F to the bung which is not shown in FIG. 2.

[0171] While the bung 20 is pushed towards a distal direction 14 of the cartridge 10 by means of the piston the bung 20 is compressed. Due to the low compressibility of the bung 20 caused by the properties of the second material 42 on which the force of the piston is applied, this assembly provides the bung 20 with a reduced relaxation time after compression. This leads to a reduced dripping time after injection and to a better dose accuracy.

[0172] FIG. 3 shows a cartridge as described in FIG. 2. The cartridge 10 comprises a bung 20 comprising two materials as mentioned in the description of FIG. 2. One difference is that the bung 20 comprises an electronic coding feature 30. Another difference is that the first material 40 covers the whole surface of the bung 20.

[0173] The electronic coding feature 30 carries information regarding the content of the cartridge and the cartridge 10 itself. The information includes the production date, the type of medicinal product that is contained and the expiry date of the content of the cartridge 10. Additional information can be stored on the electronic coding feature 30 like for example the temperature while storing, the liquid level of the cartridge 10 measured by additional sensors and transmitted to the electronic coding feature 30.

[0174] Due to the special structure comprising two different materials, the compression is limited by the layer thickness of the first material 40 at the distal end face 22 of the bung 20 and by the low compressibility of the second material 42 inside the bung 20. By having a flat surface structure at the lateral area 26 of the bung 20, the first material 40 located at the lateral area 26 is comparatively less squeezed in proximal direction while being pushed towards the narrowing shoulder portion 16 during dispensing the last dose from the cartridge 10. Thus, the dose accuracy is increased and the retention time of the bung 20 after compression is decreased.

[0175] The stored information can be read-out by means of a device that is able to interact with the electronic coding feature 30. New data regarding the content of the cartridge or the cartridge 10 can be stored on the electronic coding feature 30 at any time.

[0176] FIGS. 4a and 4b show a means that is able to interact with the electronic coding feature 30.

[0177] In FIG. 4a external means 44 are shown that interact with the electronic coding feature 30 which is comprised in the bung 20 of a cartridge 10. The external means 44 enables the user to find one particular cartridge 10 which might contain one particular medicinal product within a batch of other cartridges containing another medicinal product.

[0178] In FIG. 4b an internal means 46 is shown which is able to interact with the electronic coding feature 30. The means is located inside a drug delivery device 48.

[0179] FIG. 5 shows a view onto a proximal end face 24 of an embodiment of a bung 20 carrying a protruding ring as a first mechanical coding feature 28. The protruding ring 28 has a radius r and is provided to fit into a corresponding annular trench, which is provided on the drug delivery device 48 as a second mechanical coding feature 29. A suitable cartridge 10 may be identifiable and/or distinguishable by the radius r of the protruding ring 28, which may be different for different types of cartridges 10 or different contents of cartridges 10, for example.

[0180] FIG. 6 shows a view onto a proximal end face 24 of a further embodiment of a bung 20 carrying a protruding ring as a first mechanical coding feature 28. In the embodiment of FIG. 6, the protruding ring 28 has a larger radius r than the protruding ring 28 of the embodiment according to FIG. 5. The second mechanical coding feature 29 is adapted to the radius r of the protruding ring 28 and may be an annular trench having the same radius.

[0181] FIG. 7 shows a cross-sectional view of an arrangement of a protruding ring of radius r provided as a first mechanical coding feature 28 of a bung 20 and a second mechanical coding feature 29 provided on the drug delivery device 48 as a counterpart of the first mechanical coding feature 28. The FIG. 7 shows that the protruding ring 28, which is applied to the proximal end face 24 of the bung 20, fits into a corresponding annular trench forming the second mechanical coding feature 29 of the drug delivery device 48.

[0182] FIG. 8 shows a cross sectional view of an arrangement of a further embodiment of a protruding ring provided as a first mechanical coding feature 28 of a bung 20 and a second mechanical coding feature 29 provided on the drug delivery device 48 as a counterpart of the further first mechanical coding feature 28. The protruding ring 28 is applied to the proximal end face 24 of the bung 20 and fits into a corresponding annular trench forming the second mechanical coding feature 29 of the drug delivery device 48. The protruding ring 28 of the embodiment according to FIG. 8 and the corresponding trench have a larger radius r than the protruding ring 28 of the embodiment according to FIG. 7.

[0183] FIG. 9 shows a cross-sectional view of an arrangement of a first mechanical coding feature 28 of a bung 20 according to FIG. 7 and a second mechanical coding feature 29 provided as a counterpart of a first mechanical coding feature according to FIG. 8.

[0184] The first mechanical coding feature 28 is a protruding ring of radius r, and the second mechanical coding feature 29 is a trench of larger radius. The FIG. 9 shows that the first mechanical coding feature 28 and the second mechanical coding feature 29 do not fit in this arrangement, and hence a selection of the cartridge 10 is facilitated.

[0185] FIG. 10 shows a cross-sectional view of an arrangement of a first mechanical coding feature 28 of a bung 20 according to FIG. 8 and a second mechanical coding feature 29 provided as a counterpart of a first mechanical coding feature according to FIG. 7. The first mechanical coding feature 28 is a protruding ring of radius r, and the second mechanical coding feature 29 is a trench of smaller radius. The FIG. 10 also shows that the first mechanical coding feature 28 and the second mechanical coding feature 29 do not fit in this arrangement, and hence a selection of the cartridge 10 is facilitated.

[0186] FIG. 11 shows a view onto a proximal end face 24 of an embodiment of a bung 20 carrying a plurality of relief structures provided as a first mechanical coding feature 28. In this embodiment the relief structures are similar to one another and have an elongated shape, so that a length l of the relief structures can be defined by a maximal dimension of a relief structure measured in the plane of the proximal end face 24. The relief structures may be disposed on a circle, for example, as shown in FIG. 11, and in this embodiment the relief structures are arranged parallel to a radius of the circle. This means that the length l is measured in the direction of a radius of the circular proximal end face 24. The relief structures are arranged at a minimal distance d from one another. In the embodiment of FIG. 11, the minimal distance d is the same for each pair of neighboring relief structures.

[0187] FIG. 12 shows a view onto a proximal end face 24 of a further embodiment of a bung 20 carrying a plurality of relief structures provided as a first mechanical coding feature 28. In this embodiment the relief structures are similar to one another and have an elongated shape, so that a length l of the relief structures can be defined by a maximal dimension of a relief structure measured in the plane of the proximal end face 24. In this embodiment the length l is larger than the length of the relief structures of the embodiment according to FIG. 11. In the embodiment according to FIG. 12, the relief structures are arranged on a circle, and each relief structure is arranged transverse to a radius of the circle.

[0188] In further embodiments the relief structures may have different lengths and/or different directions and/or different minimal distances from one another. The relief structures need not be arranged on a circle, although a rotationally symmetric arrangement of the relief structures may be preferred. The relief structures need not have the same shape. They may be statistically dispersed on the proximal end face 24, although a regular arrangement of similar relief structures may be preferred to facilitate the formation of the corresponding second mechanical coding features 29 of the drug delivery device 48.

[0189] FIG. 13 shows a view onto a proximal end face 24 of a further embodiment of a bung 20 carrying a plurality of relief structures provided as a first mechanical coding feature 28. Compared to the embodiment of FIG. 12, the embodiment of FIG. 13 comprises relief structures of smaller length l, which are arranged on a circle of smaller radius and at a larger minimal distance d from one another.

[0190] FIG. 14 shows an arrangement of a larger number of relief structures on a circle and transverse to a radius of the circle. The length l and the minimal distance d are again different from the corresponding dimensions of the previously described embodiments. FIGS. 12 to 14 show how a plurality of relief structures can be designed according to the same basic pattern, which allows for sufficient differences to enable an identification of different cartridges 10. The bungs 20 can thus be provided with different mechanical coding features in essentially the same manufacturing process.

[0191] The first mechanical coding feature 28 of the bung 20 may especially be a separator, which is also provided to facilitate a separation of the bungs during a bulk storage. The separators are protruding structures on the surface of a bung and prevent the bungs from adhering to one another when they are stored together in a bulk.

REFERENCE NUMERALS

[0192] 10 cartridge

[0193] 12 proximal end of the cartridge

[0194] 14 distal end of the cartridge

[0195] 16 shoulder portion

[0196] 18 main body portion

[0197] 20 bung

[0198] 22 distal end face

[0199] 23 edge of the distal end face

[0200] 24 proximal end face

[0201] 26 lateral area

[0202] 28 mechanical coding feature

[0203] 29 counterpart of the mechanical coding feature

[0204] 30 electronic coding feature

[0205] 40 first material

[0206] 42 second material

[0207] 44 external means

[0208] 46 internal means

[0209] 48 drug delivery device

[0210] d minimal distance

[0211] F force

[0212] l length

[0213] r radius