CARTRIDGE ASSEMBLY AND FIXING MEMBER
20250229027 ยท 2025-07-17
Inventors
- Michael Helmer (Frankfurt am Main, DE)
- Reinhard Rieger (Obertshausen, DE)
- Martin Vitt (Frankfurt am Main, DE)
Cpc classification
A61M5/28
HUMAN NECESSITIES
A61M5/2422
HUMAN NECESSITIES
A61M5/14566
HUMAN NECESSITIES
A61M2207/00
HUMAN NECESSITIES
International classification
Abstract
The present disclosure relates to a cartridge assembly provided with a fixing member, wherein the fixing member is configured for fastening to a cartridge, wherein the cartridge is configured for insertion into a housing component of a drug delivery device, wherein the housing component comprises a sidewall confining a cartridge receiving space, the cartridge receiving space extending in a longitudinal direction (z), the fixing member comprising: a fastening portion for fastening to a neck portion of the cartridge, a fixing structure comprising a first fixing element configured to engage with a counter fixing structure of the housing component, and an alignment portion configured to align with a counter alignment structure provided on or in the sidewall of the cartridge holder.
Claims
1. A fixing member for fastening to a cartridge, wherein the cartridge is configured for insertion into a housing component of a drug delivery device, wherein the housing component comprises a sidewall confining a cartridge receiving space, the cartridge receiving space extending in a longitudinal direction, the fixing member comprising: a fastening portion for fastening to a neck portion of the cartridge, a fixing structure comprising a first fixing element configured to engage with a counter fixing structure of the housing component, and an alignment portion configured to align with a counter alignment structure provided on or in the sidewall of the housing component.
2. The fixing member according to claim 1, wherein the alignment portion is configured to orient the fixing member in at least one correct or dedicated orientation relative to the housing component and/or relative to the counter fixing structure.
3. The fixing member according to claim 1, wherein the counter alignment structure extends along the longitudinal direction and wherein the alignment portion is configured to engage and/or to slide along the counter alignment structure.
4. The fixing member according to claim 1, wherein when fastened to the neck portion of the cartridge inserting of the fixing member into the housing component is only possible with the alignment portion correctly align and correctly oriented with regard to the counter alignment structure.
5. The fixing member according to claim 1, wherein when the alignment portion is misaligned relative to the counter alignment structure the fixing structure will not be able to engage the counter fixing structure.
6. The fixing member according to claim 1, wherein the fixing structure is configured to engage with the counter fixing structure in longitudinal direction and to fix the cartridge relative to the housing component with regard to the longitudinal direction.
7. The fixing member according to claim 1, wherein the alignment portion comprises one of a radial protrusion and a radial alignment recess to engage with one of a complementary shaped radial alignment recess and a radial protrusion on an inside surface of the sidewall of the housing component.
8. The fixing member according to claim 1, wherein the fastening portion comprises a fastening ring comprising a first ring portion and a second ring portion separated from each other by a slit opening.
9. The fixing member according to claim 8, wherein the fastening ring comprises a middle portion interconnecting the first ring portion and the second ring portion.
10. The fixing member according to claim 9, wherein the alignment portion is provided on an outside surface of the middle portion.
11. The fixing member according to claim 8, wherein the fixing structure further comprises a second fixing element, wherein the first fixing element is provided on the first ring portion and wherein the second fixing element is provided on the second ring portion.
12. The fixing member according to claim 8, wherein the alignment portion comprises a longitudinal extension protruding in longitudinal direction from the fastening ring.
13. The fixing member according to claim 1, wherein the first fixing element comprises a snap element, the snap element comprises an abutment face facing towards a proximal longitudinal direction to abut with a complementary shaped abutment face of the housing component and further comprises a beveled edge facing towards a distal longitudinal direction.
14. A cartridge assembly for a drug delivery device, comprising: a cartridge comprising a tubular shaped barrel containing a medicament, wherein the cartridge comprises a neck portion, a housing component of a drug delivery device, the housing component comprising: a sidewall confining a cartridge receiving space extending in a longitudinal direction, a counter fixing structure, a counter alignment structure provided on or in the sidewall, a fixing member according to claim 1 fastenable to the neck portion, and, when fastened to the neck portion of the cartridge being configured to engage with the counter fixing structure and to align with the counter alignment structure upon insertion of the cartridge into the cartridge receiving space.
15. The cartridge assembly according to claim 14, wherein the housing component comprises a cartridge holder comprising a proximal end configured for attachment to a body of the drug delivery device, wherein the proximal end comprises an insert opening sized to receive the cartridge with the fixing member attached thereto in only one or several orientations of the cartridge and the fixing member relative to the cartridge holder with regard to the longitudinal direction as an axis of rotation.
16. The cartridge assembly according to claim 14, wherein the counter alignment structure comprises a longitudinally extending alignment recess on an inside of the sidewall, which longitudinally extending alignment recess is complementary shaped to the radially outwardly protruding alignment portion of the fixing member.
17. The cartridge assembly according to claim 14, wherein the counter fixing structure provided in or on the sidewall is configured to engage with the first fixing element of the fixing member when the cartridge provided with the fixing member reaches a final assembly position inside the cartridge receiving space.
18. The cartridge assembly according to claim 17, wherein the first fixing element is longitudinally aligned with a first counter fixing element through an alignment of the alignment portion of the fixing member with the counter alignment structure of the sidewall upon insertion of the cartridge and the fixing member into the cartridge receiving space.
19. A method of assembling a cartridge assembly of a drug delivery device, the method comprising the steps of: fastening of a fixing member according to claim 1 to a neck portion of a cartridge, aligning the alignment portion with a counter alignment structure provided on or in a sidewall of a cartridge holder of the drug delivery device, inserting the cartridge and the fixing member into a cartridge receiving space of the cartridge holder, and bringing the fixing structure of the fixing member in engagement with the counter fixing structure when the cartridge reaches a final assembly position in the cartridge receiving space.
20. A drug delivery device, comprising: a body, a drive mechanism arranged inside or attached to the body and comprising a piston rod configured to exert a dispensing force onto a piston located inside a barrel of a cartridge, a cartridge assembly according to claim 14 and connectable to the body.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0099] In the following, numerous examples of a data logging device for monitoring use of an injection device as well as a respective injection device will be described in greater detail by making reference to the drawings, in which:
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DETAILED DESCRIPTION
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[0117] The barrel 11, which may be of a vitreous material, such as glass, comprises a sidewall 12 with a main portion 14 of substantially tubular shape. The piston 25 is slidably displaceable along the main portion 14. Towards the dispensing and 27 the main portion 14 merges into a narrow win shoulder portion 16, which in turn merges in to a radially stepped down neck portion 16. The neck portion 16 terminates with a head portion 18, which, at least on its outside surface may comprise a somewhat radially widened cross-section compared to the neck portion.
[0118] The drug delivery device 1 further comprises a protective cap 4 configured to cover the dispensing end 27 of the drug delivery device 1. Typically, the housing component 30 is implemented as a cartridge holder 31. The housing component 30 comprises a distal end 43 and a proximal end 44. The distal end 43 is configured to engage with a needle assembly, e.g. a double-tipped injection needle by way of which a dose of the liquid medicament 26 can be injected into biological tissue. For this, the distal end 43 of the cartridge holder 31 comprises a threaded section 49 which supports and allows for a threaded connection with a complementary shaped needle hub equipped with the injection needle.
[0119] The distal end 43 of the cartridge holder 31 further comprises an aperture 50 to receive a proximal portion or a proximally extending portion of the double-tipped injection needle. The injection needle is configured to pierce and/or to penetrate a seal 20 at the distal end of the cartridge 10. The seal 20 may comprise a pierceable septum 21, which is fixed to a distally located head portion 18 of the cartridge by way of a septum retainer 22. The septum retainer 22 may comprise a beaded cap 23, e.g. made of a pliable material, such as aluminum or plastic.
[0120] The septum retainer 22 comprises an aperture 24 that aligns with the aperture 50 when the cartridge 10 is received in the interior of the cartridge holder 31. Inside the cartridge holder 31 there is provided a cartridge receiving space 33, which is effectively occupied by the cartridge 10 when assembled inside the cartridge holder 31. The cartridge holder 31 comprises a proximal end 44, which may be provided with an insert 52 sized and configured for insertion into a receptacle 82 as provided at the distal end of the body 6. towards the distal direction 2, the insert 52 is delimited by a flange portion 55. When the cartridge holder 31 is attached to the body 6, the flange portion 55 may be in longitudinal abutment with a distal end face of the sidewall of the receptacle 82.
[0121] On the inside of the receptacle 82 there may be provided a counter fastening structure 83, e.g. in form of a radial protrusion or radial recess to engage with a complementary shaped fastening element 53 as provided on an outside surface of the insert 52. This way, the proximal end 44 of the cartridge holder 31 can be fixed and attached to the body 6.
[0122] Optionally, the proximal end 44 of the cartridge holder 31 comprises a coding element 54 by way of which the cartridge assembly 150 can be mechanically encoded to distinguish from another cartridge assembly 150, e.g. equipped with a different type of cartridge 10 or with a cartridge containing a different medicament 26. The coding element 54 or coding feature may be complementary shaped or complementary positioned to a counter coding element 84 as provided on or inside the body 6. A nonmatching pair of a coding element 54 and a counter coding element 84 may prevent a mutual fastening of the cartridge holder 31 to the body 6.
[0123] A mutual fastening and fixing of the cartridge holder 31 to the body 6 may be only provided and allowed when the coding element 54 of the cartridge holder 31 matches in size, shape and position with the corresponding counter coding element 84 as provided on or inside the body 6.
[0124] In one aspect the present disclosure relates to a cartridge assembly 150 comprising a cartridge holder 31, a cartridge 10 and a fixing member 100. The fixing member 100, which is illustrated in greater detail in
[0125] With the example as illustrated in
[0126] The fixing member 100 further comprises a fixing structure 120. The fixing structure 120 is configured to fix the fixing member 100 inside the cartridge receiving space 33 as illustrated in
[0127] As it becomes apparent from the illustration of the numerous
[0128] Since the fixing member 100 is configured for insertion into the cartridge receiving space 33 obtaining of a proper alignment of the fixing structure 120 with the counter fixing structure 60 may be difficult to achieve. For this, the alignment portion 130 is configured to engage with the counter alignment structure 34 as provided on the inside 41 of the sidewall 32 of the cartridge holder 31. The alignment portion 130, which is positionally fixed relative to the fixing structure 120 can be and remain in a keyed engagement with the sidewall 32 of the cartridge holder 31 during and for insertion of the cartridge 10 into the cartridge holder 31. The keyed engagement between the alignment portion 130 and the counter alignment structure 34 rotationally locks the fixing member 100 relative to the cartridge holder 31 and longitudinally guides the fixing structure 120 into engagement with the counter fixing structure 60 of the cartridge holder 31.
[0129] As illustrated in greater detail in
[0130] The alignment portion 130 further comprises a longitudinal extension 138 protruding in longitudinal direction from the fastening portion 110. The longitudinal extension 138 provides a symmetry breaking feature for the fastening ring 111. When attached to the cartridge the longitudinal extension 138 it should protrude in proximal direction 3 from the fastening portion. In this way, the fixing structure 120 will be correctly oriented with regard to the longitudinal direction (z). Moreover, the longitudinal extension 138 may also serve as a handle so as to facilitate gripping and/or fastening the fixing member 100 to the cartridge 10.
[0131] As particularly illustrated in
[0132] On an outside facing portion of the fixing member 100 the alignment portion 130 merges into the fastening portion 110 via a shoulder portion 135. The shoulder portion 135 comprises a stepped profile and a distally facing abutment face 136 by way of which the fixing member 100 adapts the shape of the inside surface of the shoulder portion 45 of the sidewall 32 of the cartridge holder 31. As illustrated in
[0133] As shown in greater detail in
[0134] As further illustrated in
[0135] As it is particularly illustrated in
[0136] On the inside of the sidewall 32 of the cartridge holder 31 there is provided at least one alignment recess 42 that is complementary shaped to the cross-section of the alignment portion 130. The alignment portion 130 in alignment with the alignment recess 42 is particularly illustrated in
[0137] In the cross-section of
[0138] As it is further apparent from
[0139] With further examples, wherein there is provided only a first and a second counter fixing element 61, 62 there may be provided only one alignment recess 42 on the inside 41 of the sidewall 32 thus enforcing only one dedicated alignment or orientation of the fixing member 100 relative to the internal keying or coding structure of the sidewall 32 of the cartridge holder 31.
[0140] The alignment recess 42 may extend all along the main portion 47 of the sidewall 32 of the cartridge holder 31. It may adjoin the insert opening 48 through which the fixing member 100 attached to the cartridge 10 is to be inserted in a longitudinal distal direction 2 into the cartridge receiving space 33. While the alignment portion 130 is and remains in engagement with the counter alignment structure 34, e.g. with the alignment recess 42, there is provided a keyed and rotation inhibiting engagement between the fixing member 100 and the cartridge holder 31.
[0141] As the cartridge 10 and the fixing member 100 are urged in distal direction 2 towards the final assembly position as illustrated in
[0142] Once the beveled edges 126 have longitudinally passed the beveled edges 56 the proximally facing abutment face 125 of the fixing elements 121, 122 get in longitudinal abutment with the distally facing abutment faces 65 of the counter fixing element 61, 62, thereby inhibiting a proximally directed displacement and hence a removing of the fixing member 100 in proximal direction 3 out of the cartridge receiving space 33.
[0143] A user trying to pull the cartridge 10 in proximal direction 3 out of the cartridge holder 31 will induce a proximally directed force effect of the head portion 18 being in abutment with the distally facing side of the fastening ring 111. Accordingly, a respective proximal force effect will be transferred to the fastening portion 110, which force is counteracted by the distally facing abutment faces 65 of the counter fixing structure 60.
[0144] With some examples of the cartridge assembly 150, wherein the counter fixing structure 60 comprises one or numerous through openings 64 being accessible from outside, it is generally conceivable to induce a deformation of at least one of the fixing element 121, 122 and the counter fixing structure 60, e.g. by a dedicated tool, so as to abrogate the axial or longitudinal fixing abutment between the abutment face 65 and the abutment face 125.
[0145] Towards a distal end of the cartridge 10, e.g. a distal end face of the septum retainer 22 may be in abutment with an end wall 57 of the cartridge holder 31. Furthermore, and as described above in connection with
[0146] In the flowchart of
[0147] With a correct alignment, e.g. when the radial protrusion 131 of the alignment portion 130 is oriented and aligned with the longitudinally extending alignment recess 42 as provided on the inside surface 41 of the sidewall 32 the cartridge 10 provided with the fixing member 100 can be inserted into the cartridge receiving space 33 in longitudinal direction towards the distal end 43 of the cartridge holder 31 in step 202.
[0148] Thereafter and upon or before reaching the final assembly position the fixing structure 120 of the fixing member 100 is brought in engagement with the counter fixing structure 60 in step 203. Here and as illustrated in
REFERENCE NUMBERS
[0149] 1 drug delivery device [0150] 2 distal direction [0151] 3 proximal direction [0152] 4 protective cap [0153] 5 medicament container [0154] 6 body [0155] 7 drive mechanism [0156] 8 dose member [0157] 9 trigger [0158] 10 cartridge [0159] 11 barrel [0160] 12 sidewall [0161] 14 main portion [0162] 15 shoulder portion [0163] 16 neck portion [0164] 18 head portion [0165] 20 seal [0166] 21 septum [0167] 22 septum retainer [0168] 23 beaded cap [0169] 24 aperture [0170] 25 piston [0171] 26 medicament [0172] 27 dispensing end [0173] 30 housing component [0174] 31 cartridge holder [0175] 32 sidewall [0176] 33 cartridge receiving space [0177] 34 counter alignment structure [0178] 35 sidewall section [0179] 36 ridge portion [0180] 37 sidewall section [0181] 38 ridge portion [0182] 39 sidewall section [0183] 40 ridge portion [0184] 41 inside surface [0185] 42 alignment recess [0186] 43 distal end [0187] 44 proximal end [0188] 45 shoulder portion [0189] 46 neck portion [0190] 47 main portion [0191] 48 insert opening [0192] 49 threaded section [0193] 50 aperture [0194] 52 insert [0195] 53 fastening element [0196] 54 coding element [0197] 55 flange portion [0198] 56 beveled edge [0199] 57 end wall [0200] 60 counter fixing structure [0201] 61 counter fixing element [0202] 62 counter fixing element [0203] 63 recess [0204] 64 through opening [0205] 65 abutment face [0206] 80 piston rod [0207] 81 pressure piece [0208] 82 receptacle [0209] 83 counter fastening structure [0210] 84 counter coding element [0211] 100 fixing member [0212] 101 body [0213] 110 fastening portion [0214] 111 fastening ring [0215] 112 slit opening [0216] 113 ring portion [0217] 114 ring portion [0218] 115 middle portion [0219] 116 outside surface [0220] 120 fixing structure [0221] 121 fixing element [0222] 122 fixing element [0223] 123 snap element [0224] 124 nose [0225] 125 abutment face [0226] 126 beveled edge [0227] 130 alignment portion [0228] 131 protrusion [0229] 132 outside surface [0230] 133 outside surface [0231] 134 outside surface [0232] 135 shoulder portion [0233] 136 abutment face [0234] 138 extension [0235] 139 inside surface [0236] 150 cartridge assembly