Piston for a Cartridge for Use in a Drug Delivery Device

Abstract

The present invention relates to a piston for a cartridge to be filled with a medicament, the piston comprising: a first piston member (12) comprising a first material and forming a distal end face (22) of the piston, a second piston member (14) comprising a second material of lower compressibility compared to the first material, wherein the second piston member (14) is arranged in a cupped receptacle (16) of the first piston member (12) and provides a thrust receiving surface (25) at a proximal end (24) of the piston.

Claims

1-14. (canceled)

15. A piston for a cartridge to be filled with a medicament, the piston comprising: a first piston member forming a distal end face of the piston, a second piston member, wherein the second piston member is arranged in a cupped receptacle of the first piston member and providing a thrust receiving surface at a proximal end of the piston, further comprising an electronic circuit arranged between the first piston member and the second piston member, wherein the electronic circuit is designed as a microchip.

16. The piston according to claim 15, wherein the electronic circuit comprises a data storage.

17. The piston according to claim 15, wherein the electronic circuit comprises at least one of a temperature sensor and a light-sensitive sensor.

18. The piston according to claim 15, wherein the electronic circuit comprises a communication unit.

19. The piston according to claim 15, wherein the communication unit is a wireless communication unit.

20. The piston according to claim 19, wherein the communication unit comprises a RFID element configured to communicate with a reading device.

21. the Piston according to claim 16, wherein the data storage si configured to store at least a manufacturing date and/or manufacturing time.

22. The piston according to claim 15, wherein the electronic circuit is arranged between a proximally directed bottom face of the first piston member and a distally directed end face of the second piston member, which bottom face and end face mutually abut.

23. The piston according to claim 15, wherein the thrust receiving surface of the second piston member is flush-mounted with a proximal end face of the first piston member to form an even or flat shaped proximal surface of the piston.

24. The piston according to claim 15, wherein the first and the second piston member form or constitute the entire piston.

25. The piston according to claim 15, wherein the first and/or the second piston member are of cylindrical or tubular shape and wherein the first piston member laterally embraces the second piston member.

26. The piston according to claim 15, wherein the second piston member comprises a shape and geometry to entirely fill the receptacle provided by the first piston member.

27. The piston according to claim 15, wherein the second piston member buts with a bottom face of the first piston member in axial direction.

28. The piston according to claim 15, wherein the thrust receiving surface of the second piston member is flush-mounted with a proximal end face of the first piston member to form the proximal surface of the piston having an even or flat shape.

29. The piston according to claim 15, wherein a bottom portion of the first piston member comprises an axial extension smaller than 20%, smaller than 10% or smaller than 5% of the total axial elongation of the piston or of the first piston member.

30. The piston according to claim 15, wherein the second piston member is press-fitted in the receptacle of the first piston member.

31. The piston according to claim 15, wherein the distal end face of the second piston member and/or a bottom face of the first piston member comprise a recess to receive the electronic circuit.

32. The piston according to claim 15, wherein the second piston member comprises an axial elongation of at least 80%, 90% or at least 95% of the total axial elongation of the piston.

33. A cartridge to be used with a drug delivery device comprising a tubular shaped body confining a inner volume at least partially filled with a medicament and being sealed by a piston displaceably arranged in the tubular body in an axial direction, wherein the piston comprises: a first piston member forming a distal end face of the piston a second piston member, wherein the second piston member is arranged in a cupped receptacle of the first piston member and providing a thrust receiving surface at a proximal end of the piston, further comprising an electronic circuit arranged between the first piston member and the second piston member, wherein the electronic circuit is designed as a microchip.

34. A method of manufacturing a piston comprising the steps of: providing a first piston member having a cupped receptacle, inserting a second piston member into the receptacle. arranging an electronic circuit in the receptacle of the first piston member or in a recess of the second piston member prior to insertion of the second piston member in the receptacle of the first piston member.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0061] In the following, a preferred embodiment of the invention will be described by making reference to the drawings, in which:

[0062] FIG. 1 schematically illustrates a cross-sectional side view of the piston,

[0063] FIG. 2 is indicative of a lateral cross section of the piston according to FIG. 1 along A-A and

[0064] FIG. 3 shows a typical cartridge design.

DETAILED DESCRIPTION

[0065] The piston 10 as illustrated in FIGS. 1 and 2 comprises two components, namely an outer and circumferential first piston member 12 and an inner second piston member 14 that serves as a rigid core to provide reduced axial compressibility of the entire piston 10. The first piston member 12 typically made of bromobutylene-rubber or chlorobutylene-rubber and thereby featuring a comparatively large mechanical compressibility has a cupped receptacle 16 of substantially cylindrical shape which is accessible from the proximal end of the piston 10.

[0066] In the present context, distal direction 1 points towards the inner volume of a cartridge 40 which is for instance shown in FIG. 3. The opposite proximal direction 2 points towards a thrust exerting mechanical component, such like a piston rod which is not explicitly shown. The piston 10 as illustrated in FIG. 1 therefore comprises a distal end face 22 which may get in direct contact with the inner volume of the cartridge 40 and hence with the liquid medicament. The opposite end face 24 is in turn adapted to act as a thrust receiving surface and to get in direct contact with a thrust exerting mechanical component of e.g. with a piston rod of a drive mechanism of a drug delivery device.

[0067] The cupped receptacle 16 of the first piston member 12 is entirely filled with the second piston member 14 featuring a lower compressibility than the material of the first piston member 12. This way, the second piston member 14 provides enhanced mechanical rigidity and stability and therefore reduces axial compressibility of the piston 10 when the piston 10 is subject to distally directed thrust acting on the proximal end face 24. The second piston member 14 may comprise a polymeric material such a COC having a lower compressibility than the material used for the first piston member 12. First and second piston members 12, 14 are for instance frictionally engaged. The lateral side wall of the cylindrically-shaped second piston member 14 is gets in direct and frictional contact with the inside facing side wall 20 of the first piston member 12.

[0068] Moreover as indicated in FIG. 1, a proximally located end face 25 of the second piston member 14 is flush-mounted with a proximal end face 27 of the first piston member 12. This way, proximal end faces 25, 27 of second and first piston members 14, 12 mutually complement to provide a substantially flat and even shaped proximal thrust receiving surface 24 of the piston 10. In alternative embodiments, the proximal end face 25 of the second piston member 14 may proximally protrude from the first piston member or may also be recessed in distal direction 1.

[0069] It is of further benefit, when the radial dimension of the second piston member 14 mates and corresponds with a thrust exerting distal component of a piston rod or with a comparable drive member of a drug delivery device. This way, distally directed thrust can be entirely transferred to the second piston member 14 which is adapted to transfer a respective thrust to an inward facing bottom surface 18 of a bottom portion 13 of the first piston member 12. Consequently, externally applied distally directed thrust can be directly transferred to the bottom portion 13 of the first piston member 12, which due to its reduced axial dimensions compared to the axial dimensions of the second piston member 14, may then only be subject of an almost insignificant axial compression.

[0070] The lateral side wall section 15 of the first piston member 12 may only be subject of an axially directed tension or drag force. In effect, the side wall 15 may no longer be subject to axial compression.

[0071] The first piston member 12 may further comprise distally and/or proximally located sealing lips 26, 28 which extend radially outwardly and which are adapted to frictionally engaged with the inside facing side walls of the cartridge's body.

[0072] As further illustrated in FIG. 1, at least one electronic circuit 30 may be arranged in the interface region between first and second piston members 12, 14. For this purpose, either the first piston member 12 and/or the second piston member 14 may comprise a recess to receive the electronic circuit 30, which by its arrangement between the piston members 12, 14 is not visible from outside.

[0073] However, the electronic circuit 30 may be equipped with wireless communication means, such like an RFID element allowing to read out genuine information about the piston and/or the cartridge. This way, an effective anti-counterfeiting means can be implemented into a piston 10 in a substantially non-visible way.

[0074] As further illustrated in FIG. 3, the piston 10 typically serves as a proximal seal confining an inner volume 44 of a cartridge 40. The piston 10 is slidably positioned in a tubular shaped body 42 of the cartridge. Near a distal end the cartridge 40 comprises a bottle-necked outlet end 46. There, another but pierceable seal 48 is provided that acts as a septum. The seal 48 is kept in position by way of a beaded cap 50. The septum 48 is intended to be pierced by a a double tipped needle 52 to dispense a predefined dose of the medicament e.g. into biological tissue.

LIST OF REFERENCE NUMERALS

[0075] 1 distal direction [0076] 2 proximal direction [0077] 10 piston [0078] 12 first piston member [0079] 13 bottom portion [0080] 14 second piston member [0081] 15 lateral side wall [0082] 16 cupped receptacle [0083] 18 bottom surface [0084] 20 side wall [0085] 22 distal face [0086] 24 proximal face [0087] 25 thrust receiving surface [0088] 26 sealing lip [0089] 27 proximal face [0090] 28 sealing lip [0091] 30 electronic circuit [0092] 40 cartridge [0093] 42 body [0094] 44 inner volume [0095] 46 outlet end [0096] 48 seal [0097] 50 cap [0098] 52 needle