Medicament Container

20220249325 ยท 2022-08-11

    Inventors

    Cpc classification

    International classification

    Abstract

    The present disclosure relates to a medicament container for accommodating a liquid medicament. The medicament container includes an elongated container barrel defining a longitudinal direction and having a proximal end and a distal end. The proximal end is opposite the distal end. The container barrel includes a proximal container cross section at the proximal end. The elongated container barrel includes a distal container cross section at the distal end and the proximal container cross section is substantially identical to the distal container cross section. The medicament container further includes a seal arranged at the distal end and extending across the distal container cross section, and a retainer engaged with the seal and engaged with the elongated container barrel to fix the seal to the distal end.

    Claims

    1.-19. (canceled)

    20. A medicament container for accommodating a liquid medicament, the medicament container comprising: an elongated container barrel defining a longitudinal direction and comprising a proximal end and a distal end, wherein the proximal end is opposite the distal end, wherein the elongated container barrel comprises a proximal container cross section at the proximal end, wherein the elongated container barrel comprises a distal container cross section at the distal end and wherein the proximal container cross section is substantially identical to the distal container cross section; a seal arranged at the distal end and extending across the distal container cross section; and a retainer engaged with the seal and engaged with the elongated container barrel to fix the seal to the distal end.

    21. The medicament container of claim 20, wherein the retainer comprises a proximal fastener engaged with the proximal end of the elongated container barrel.

    22. The medicament container of claim 21, wherein the proximal fastener comprises a distally facing abutment face configured to abut in longitudinal direction with a proximal end face of the elongated container barrel.

    23. The medicament container of claim 20, wherein the retainer comprises a distal fastener engaged with at least one of the distal end of the elongated container barrel and the seal.

    24. The medicament container of claim 23, wherein the distal fastener comprises a proximally facing abutment face configured to abut in a longitudinal direction with at least one of a distal end face of the elongated container barrel and a distal face of the seal.

    25. The medicament container of claim 20, wherein the retainer comprises an elongated retainer barrel enclosing the elongated container barrel.

    26. The medicament container of claim 25, wherein the retainer comprises an insert opening at a proximal end of the elongated retainer barrel, wherein the insert opening is shaped or configured to receive the elongated container barrel therethrough in longitudinal direction.

    27. The medicament container of claim 20, wherein the retainer comprises an elongated sidewall and a front face, wherein the front face is located at a distal end of the retainer and wherein the front face protrudes inwardly from the elongated sidewall.

    28. The medicament container of claim 27, wherein the front face comprises an aperture configured to receive an injection needle.

    29. The medicament container of claim 27, wherein the elongated sidewall comprises an outer threaded section adjacent to the front face.

    30. The medicament container of claim 20, wherein the retainer comprises at least a first elongated shaft portion and a second elongated shaft portion, the first and the second elongated shaft portions constitute or confine a receptacle configured to receive or to enclose the elongated container barrel.

    31. The medicament container of claim 30, wherein at least one of the first elongated shaft portion and the second elongated shaft portion comprises an inwardly protruding protrusion at a proximal end of the retainer.

    32. The medicament container of claim 30, wherein the first elongated shaft portion and the second elongated shaft portion are mutually interconnected by at least two or several transverse web sections.

    33. The medicament container of claim 30, wherein at least one of a proximal end of a first shaft portion and a proximal end of a second shaft portion is flexibly deformable in transverse direction relative to the other one of the proximal end of the first shaft portion and the proximal end of the second shaft portion.

    34. The medicament container of claim 22, wherein the retainer comprises a distal fastener engaged with at least one of the distal end of the elongated container barrel and the seal, and wherein a longitudinal distance between the proximal fastener and the distal fastener is less than or equal to a sum of a longitudinal dimension of the elongated container barrel and a thickness of the seal in longitudinal direction.

    35. The medicament container of claim 20, wherein the elongated container barrel is sealed in proximal direction by a piston slidably arranged inside the elongated container barrel and wherein an interior volume confined by the piston, the seal and an inside of the elongated container barrel is filled with the medicament.

    36. A method of manufacturing a medicament container for accommodating a liquid medicament, the method comprising: providing an elongated container barrel defining a longitudinal direction and comprising a proximal end and a distal end, wherein the proximal end is opposite the distal end; providing an elongated retainer configured to enclose the elongated container barrel, the elongated retainer comprises a proximal fastener and a distal fastener; arranging of a seal at the distal end of the elongated container barrel such that the seal extends across a distal container cross-section, or arranging of the seal inside the elongated retainer; inserting of the elongated container barrel in longitudinal direction into the elongated retainer; and engaging of the elongated container barrel with at least one of the proximal fastener and the distal fastener.

    37. The method of claim 36, wherein the retainer comprises an elongated retainer barrel configured to enclose the elongated container barrel and wherein the elongated retainer comprises an insert opening at a proximal end of the elongated retainer barrel.

    38. The method of claim 37, wherein inserting of the elongated container barrel into the elongated retainer comprises sliding of the elongated container barrel in longitudinal distal direction through the insert opening.

    39. The method of claim 36, wherein engaging of the elongated container barrel with at least one of the proximal fastener and the distal fastener comprises establishing one of a snap joint or clip joint between the proximal fastener and the proximal end of the elongated container barrel.

    Description

    BRIEF DESCRIPTION OF THE FIGURES

    [0167] In the following, numerous examples of the injection device comprising a filling level indicator will be described in greater detail by making reference to the drawings, in which:

    [0168] FIG. 1 shows a schematic illustration of a drug delivery device equipped with a medicament container,

    [0169] FIG. 2 is another schematic exploded view of the injection device according to claim 1,

    [0170] FIG. 3 illustrates a prior art solution of a cartridge containing a liquid medicament,

    [0171] FIG. 4 shows a cross-section through a medicament container according to the present disclosure,

    [0172] FIG. 5 is a perspective illustration of the medicament container,

    [0173] FIG. 6 is an exploded view of the numerous components of the medicament container,

    [0174] FIG. 7 is a side view of the retainer of the medicament container,

    [0175] FIG. 8 is a rear view of the medicament container according to FIG. 5,

    [0176] FIG. 9 is a front view of the medicament container according to FIG. 5,

    [0177] FIG. 10 is a longitudinal cross-section through the retainer as illustrated in FIG. 7, and

    [0178] FIG. 11 is a longitudinal cross-section through the elongated container barrel.

    DETAILED DESCRIPTION

    [0179] The injection device 1 as shown in FIGS. 1 and 2 can be implemented as a pre-filled disposable injection device that comprises a housing 10 to which a needle hub or needle assembly 15 can be affixed. An injection needle 24 of the needle assembly 15 is protected by an inner needle cap 16 and either an outer needle cap 17 or a protective cap 18 that is configured to enclose and to protect a distal section of the housing 10 of the injection device 1. The housing 10 may comprise and form a main housing part configured to accommodate a drive mechanism 30. The injection device 1 further comprises a container 100 the details of which will be described below. The container 100 comprises a drug container or medicament container. It may be permanently or releasably connected to the main housing 10. The container 100 is filled with a liquid medicament.

    [0180] The needle assembly 15 comprises a threaded needle hub 22 configured for a screwed connection with a threaded section 148 at a distal end 146 of the container 100. As illustrated in FIG. 2, the very distal end of the container 100 comprises an aperture 152 a through opening configured to receive a proximally extending tipped end of the injection needle 24. In particular, the injection needle 24 of the needle assembly 15 intersects the needle hub 22 and comprises a double-tipped cannula.

    [0181] The drive mechanism 30 comprises a piston rod 26 operable to urge a piston 42 of the container 100 in distal direction 2 in order to expel the medicament from the medicament container 100. A distal end of the piston rod 26 typically comprises a pressure piece 28 having a radially widened structure compared to the elongated piston rod 26. The pressure piece 28 will get in direct mechanical contact with a proximal face of the piston 42. The piston rod 26 may comprise a threaded rod that is in threaded engagement with the housing 10.

    [0182] The drug delivery device 1 comprises a dose dial 12 and a trigger 11. In the example as illustrated in FIG. 1 the dose dial 12 and the trigger 11 are provided at a proximal end of the housing 10. The injection device 1 further comprises a dosage window 13 in which a size of a dose of the medicament currently set is visually indicated. For setting of a dose the user simply rotates the dose dial 12 in a dose incrementing direction 4 relative to the housing 10. During setting of a dose consecutive increasing numbers will show up in the dosage window 13. If a dose currently set would be too high the user has the possibility to decrease the size of a dose by dialing or rotating the dose dial 12 in the opposite, hence dose decrementing direction 5. Once a dose of appropriate size has been set or selected a dose dispensing procedure may be triggered or controlled by depressing of the trigger 11, e.g. forming a proximal end face of the injection device. The trigger 11 may be depressed in distal direction 2 by a thumb of a user in order to initiate and/or to control a dispensing operation of the injection device 1.

    [0183] The medicament container 100 is illustrated in greater detail in FIGS. 2 and 4-11. The medicament container 100 comprises an elongated container barrel 101. The container barrel 101 may comprise a sleeve made of a vitreous or plastic material. The elongated container barrel 101 comprises a tubular sidewall 102. The sidewall 102 comprises a constant diameter or constant cross-section in longitudinal direction, hence in longitudinal distal direction 2 and in longitudinal proximal direction 3. The elongated container barrel 101 comprises a proximal longitudinal end 104 and an oppositely located longitudinal distal end 106. As illustrated in FIG. 11 the proximal end 104 comprises a proximal container cross-section 114. Likewise the distal end 106 comprises a distal container cross-section 116. Since the container barrel 101 is of rather straight and tubular shape and since the elongated container barrel 101 is void of a neck portion, void of a head portion and void of a shoulder portion the proximal container cross-section 114 is substantially identical to the distal container cross-section 116.

    [0184] The medicament container 100 further comprises a seal 120 as shown in FIG. 6 and FIG. 4. The seal 120 may comprise a sealing disc 122. The sealing disc 122 comprises a proximal face 124 and an oppositely located distal face 126. As indicated in FIG. 4, the seal 120 is configured to seal the distal end 106 of the elongated container barrel 101. For this, an outer section of the proximal face 124 is in abutment with a distal end face 110 of the sidewall 102 of the container barrel 101.

    [0185] The seal 120 is fixed and arranged at the distal end 106 with the help of a retainer 140. The retainer 140 comprises or constitutes a retainer barrel 141. The retainer 140 or the retainer barrel 141 comprises a tubular or cylindrically shaped sidewall 142. The retainer 140 comprises a proximal end 144 provided with a proximal fastener 180. The retainer 140 further comprises a distal fastener 170. The distal fastener 170 is configured to engage with the seal 120 and to keep the seal 120 in abutment with the distal end 106 of the container barrel 101. The proximal fastener 180, rigidly connected in a tension stable way with the distal fastener 170 is configured to engage, e.g. to but axially or longitudinally with the proximal end face 108 of the container barrel 101.

    [0186] For this the distal fastener 170 comprises a proximally facing abutment face 174 configured to abut in longitudinal direction with the distal face 126 of the seal 120. Likewise, the proximal fastener 180 comprises a distally facing abutment face 184 to engage or to abut with the proximal end face 108 of the elongated container barrel 101.

    [0187] As becomes apparent from FIGS. 4 and 10 the proximal fastener 180 comprises a radially inwardly extending protrusion 181 protruding inwardly from the sidewall 142 of the retainer 140. The proximal fastener 180 and hence the protrusions 181 are provided and arranged at a proximal end 144 of the retainer 140. The radially inwardly extending protrusion 181 may comprise a rim 182 extending along the circular circumference of the sidewall 142. The protrusion 181 comprises a distally facing abutment face 184 configured to engage, i.e. to abut axially or longitudinally with the proximal end face 108 of the sidewall 102 of the container barrel 101.

    [0188] At the proximal end 144 the retainer 140 comprises an insert opening 185 shaped and/or configured to receive the elongated container barrel 101 therethrough in longitudinal direction. Typically, the insert opening 185 comprises a diameter or cross-section that is slightly smaller than or equal to an outside diameter or cross-section of the elongated container barrel 101. In this way, the elongated container barrel 101 can be inserted with its distal end 106 into and through the insert opening 185 in longitudinal direction, typically along the distal direction 2. When the inside diameter or cross-section of the insert opening 185 is slightly smaller than the outside diameter or cross-section of the elongated container barrel 101, the insertion of the container barrel 101 into the retainer 140 will be accompanied by a temporary elastic deformation of the sidewall 142 and/or of the insert opening 185 of the retainer 140.

    [0189] Moreover, the proximal fastener 180, e.g. the protrusions 181 of the proximal fastener 180 may form or constitute a snap joint with the proximal end 104 of the elongated container barrel 101. For instance, the protrusion or protrusions 181 may comprise a respective snap feature 186 configured to audibly and/or haptically engage with the proximal end 104 of the elongated container barrel 101. The snap feature 186 and the proximal end face 108 of the elongated container barrel 101 may constitute or form a snap joint.

    [0190] The distal fastener 170 may be formed by a front face 150 integrally formed with the sidewall 142 of the retainer 140. The front face 150 may be provided at a distal end 146 of the retainer 140. The front face 150 may comprise or may form a radially inwardly extending flange section having a central aperture 152 extending therethrough in longitudinal direction. The aperture 152 serves to receive a proximal tip of the injection needle 24 when the needle hub 22 is attached to the distal end 146 of the retainer 140. For attachment of the needle hub 22 the retainer 140 comprises a threaded section 148 at or near the distal end 146 of the sidewall 142. In this way and since the needle hub 22 comprises a complementary shaped inner thread a threaded connection between the needle hub 22 and the retainer 140 can be provided.

    [0191] An inside surface and hence a proximally facing surface 174 of the front face 150 forms or constitutes, e.g. coincides with the proximally facing abutment face of the distal fastener 170. As illustrated in FIG. 4, the inside surface of the front face 150 and hence the proximally facing abutment face 174 provides an end stop for the seal 120. In the final assembly configuration as illustrated in FIG. 4, the seal 120 is axially or longitudinally squeezed between the distal end face 110 of the container barrel 101 and the proximally facing abutment face 174 of the distal fastener 170, i.e. the proximally facing abutment face 174 of the front face 150.

    [0192] As illustrated in FIG. 4, the longitudinal distance between the proximal fastener 180 and the distal fastener 170 is less than or equal to the sum of the total axial or longitudinal elongation of the elongated container barrel 101 plus the thickness of the seal 120. In this way it can be provided, that when reaching the final assembly configuration, in which the proximal fastener 180 snaps or positively engages with the proximal end face 108 of the elongated container barrel 101, the seal 120 is squeezed in longitudinal or axial direction to a predefined degree thereby providing an increased sealing capability compared to an unbiased or non-squeezed state.

    [0193] An interior 105 of the elongated container barrel is sealed in distal direction by the sealing disc 120. It is sealed in proximal direction 3 by a piston 42 slidably arranged inside the tubular shaped elongated container barrel 101. The piston 42 is displaceable in distal direction 2 under the effect of the distally advancing piston rod 26.

    [0194] As it becomes particularly apparent from FIGS. 6, 7, 8 and 10 the elongated sidewall 142 of the retainer barrel 141 and hence of the retainer 140 comprises a first elongated sidewall portion 160 and a second elongated sidewall portion 162. These sidewall portions 160, 162 may adopt the shape of a half cylinder. The first and second elongated sidewall portions 160, 162 are mutually interconnected by web sections 163, 164, 165, 166 as illustrated in FIG. 7. The elongated and parallel extending sidewall portions 160, 162 are mutually connected on each circumferential side edge by two web sections 163, 164 and two further web sections 156, 166 as illustrated in FIG. 6.

    [0195] The web sections 164, 166 may be regarded as distal web sections because they are located distally from the two further web sections 163, 165. The further web sections 163, 165 provide or serve as proximal web sections 163, 165. The proximal web sections 163, 165 are located at a predefined distance from the proximal end 144 of the retainer 140. In this way it is provided that a proximal end 176 of the first longitudinal sidewall portion 160 is able to flex in radial direction relative to the proximal end 178 of the second longitudinal sidewall section 162. Longitudinally between the numerous web sections 163, 164 there are provided windows 167, 168, 169. The proximal window 167 is open towards the proximal end 144. It is confined in distal direction by the proximal web section 163. The middle window 168 is confined in longitudinal direction by the proximal web section 163 and the distal web section 164. The distal window 169 is confined in longitudinal direction by the threaded section 148 or the distal end 146 of the retainer 140 at a proximal direction by the distal web section 164.

    [0196] The numerous windows 167, 168, 169 provide and enable visual inspection of the content of the container barrel 101. The web sections 163, 164, 165 and 166 provide structural strengthening of the longitudinal sidewall portions 160, 162. The longitudinal sidewall portions 160, 162 form or constitute a receptacle 161 therebetween. The receptacle 161 as illustrated in FIG. 6 is sized to receive or to enclose the container barrel 101. The elongated container barrel 101 can be inserted into the receptacle 161 by insertion through the insert opening 185 provided at the proximal end 144 of the retainer 140. The proximal end of the longitudinal sidewall portions 160, 162 define or delimit the insert opening 185 as seen in radial direction.

    [0197] Since the proximal ends of the longitudinal sidewall portions 160, 162 may exhibit a certain degree of elasticity as seen in radial direction the diameter or cross-section of the insert opening 185 can be at least temporarily slightly increased during the process of inserting the elongated container barrel 101 into the receptacle 161 in longitudinal direction. When reaching a final assembly configuration, in which the proximal fastener 180 engages the proximal end 104 of the container barrel 101 the proximal end of the sidewall portions 160, 162 may return into an initial unbiased configuration. In this way, an inside diameter or cross-section of the insert opening 185 is typically slightly smaller than the respective outer diameter or cross-section of the elongated container barrel 101. When reaching the final assembly configuration, the proximal fastener 180 of the retainer 140 audibly and/or haptically engages with the proximal end 104 of the container barrel 101 thereby forming a snap joint.

    [0198] Since the proximal ends 176, 178 of the elongated sidewall portions 160, 162 are void of interconnecting web sections they are allowed to flex radially outwardly as the medicament container 100 is inserted in distal direction 2 into the receptacle 161. When reaching a final assembly configuration as illustrated in FIG. 4, The proximal end face 108 of the elongated container barrel 101 passes by the radially inwardly extending protrusion 181 or the respective rim 182 of the proximal fastener 180 thereby locking the elongated container barrel 101 in place inside the retainer 140.

    [0199] As it is further indicated in FIG. 10 the retainer 140 may be optionally provided with a further fastener 190 configured to engage with a correspondingly shaped counter fastener of the body 10 of the injection device 1. In this way the medicament container 1 can be detachably or undetachably fastened to the body 10 and may thus contribute to the housing of an injection device 1.

    [0200] The interior volume 105 of the medicament container as it is confined by the distal face of the piston 42, the proximal face 124 of the seal 120 and the inside surface 112 of the sidewall 102 may be entirely filled with the liquid medicament. It may be filled void of gas cavities. Since the outlet of the medicament container 100 is sealed across the entire distal cross-section 116 by the seal 120 a rather complete and residualless emptying of the medicament container 1 can be provided as the piston 42 is urged step-by-step or continuously in distal direction 2.

    [0201] In the empty configuration the distal face of the piston 42 may directly engage the proximal face 124 of the seal 120. The residual amount of medicament located between the seal 120 and the piston 42 can be thus reduced to a minimum.

    LIST OF REFERENCE NUMBERS

    [0202] 1 injection device [0203] 2 distal direction [0204] 3 proximal direction [0205] 4 dose incrementing direction [0206] 5 dose decrementing direction [0207] 10 body [0208] 11 trigger [0209] 12 dose dial [0210] 13 dosage window [0211] 14 cartridge holder [0212] 15 needle assembly [0213] 16 inner needle cap [0214] 17 outer needle cap [0215] 18 protective cap [0216] 20 threaded portion [0217] 22 needle hub [0218] 24 injection needle [0219] 26 piston rod [0220] 28 pressure piece [0221] 30 drive mechanism [0222] 40 cartridge [0223] 41 barrel [0224] 42 piston [0225] 43 neck portion [0226] 44 head portion [0227] 45 seal [0228] 46 cap [0229] 100 medicament container [0230] 101 container barrel [0231] 102 side wall [0232] 104 proximal end [0233] 105 interior volume [0234] 106 distal end [0235] 108 end face [0236] 110 end face [0237] 112 inside surface [0238] 114 cross section [0239] 116 cross section [0240] 120 seal [0241] 122 sealing disc [0242] 124 proximal face [0243] 126 distal face [0244] 140 retainer [0245] 141 retainer barrel [0246] 142 side wall [0247] 144 proximal end [0248] 146 distal end [0249] 148 threaded section [0250] 150 front face [0251] 152 aperture [0252] 160 shaft portion [0253] 161 receptacle [0254] 162 shaft portion [0255] 163 web section [0256] 164 web section [0257] 165 web section [0258] 166 web section [0259] 167 window [0260] 168 window [0261] 169 window [0262] 170 fastener [0263] 174 abutment face [0264] 176 proximal end [0265] 178 proximal end [0266] 180 fastener [0267] 181 protrusion [0268] 182 rim [0269] 184 abutment face [0270] 185 insert opening [0271] 186 snap feature [0272] 190 fastener