A Container for at least a First Injectable Medicament and Injection Device
20200276389 ยท 2020-09-03
Inventors
Cpc classification
A61M5/2425
HUMAN NECESSITIES
A61M2005/1787
HUMAN NECESSITIES
A61M5/2448
HUMAN NECESSITIES
A61M5/19
HUMAN NECESSITIES
A61M5/2459
HUMAN NECESSITIES
A61M5/286
HUMAN NECESSITIES
International classification
A61M5/19
HUMAN NECESSITIES
A61M5/24
HUMAN NECESSITIES
Abstract
The present disclosure relates to a container (10) for at least a first injectable medicament (60), the container comprising:an elongated body (11) having a tubular-shaped sidewall (12) extending along a longitudinal axis (z) and having a distal end (13), wherein the elongated body (11) comprises a hollow space (15) with a needle receiving subsection (17) adjacent to the distal end (13),an outlet (40) at the distal end (13) of the body (11),a piston (20) arranged inside the elongated body (11), sealingly engaged with the sidewall (12) and slidable along the longitudinal axis (z) relative to the sidewall (12),a membrane (30) arranged inside the elongated body (11) sealingly engaged with the sidewall (12) and being at least one of slidable and deformable along the longitudinal axis (z) relative to the sidewall (12),a first cavity (16) confined by the sidewall (12), the outlet (40) and the membrane (30), wherein the first injectable medicament (60) is located in the first cavity (16),a second cavity (18) confined by the sidewall (12), the piston (20) and the membrane (30), wherein the piston (20) and the membrane (30) are separated from each other by a distance along the longitudinal axis (z),wherein the outlet (40) is configured to receive or to hold a needle (50) extending from the distal end (13) into the needle receiving subsection (17), andwherein in an initial configuration, the membrane (30) is located outside the needle receiving subsection (17) and wherein the membrane (30) is displaceable or deformable relative to the sidewall (12) to such an extent that at least a portion (31) of the membrane (30) enters the needle receiving subsection (17).
Claims
1. A container (10) for at least a first injectable medicament (60), the container comprising: an elongated body (11) having a tubular-shaped sidewall (12) extending along a longitudinal axis (z) and having a distal end (13), wherein the elongated body (11) comprises a hollow space (15) with a needle receiving subsection (17) adjacent to the distal end (13), an outlet (40) at the distal end (13) of the body (11), a piston (20) arranged inside the elongated body (11), sealingly engaged with the sidewall (12) and slidable along the longitudinal axis (z) relative to the sidewall (12), a membrane (30) arranged inside the elongated body (11) sealingly engaged with the sidewall (12) and being at least one of slidable and deformable along the longitudinal axis (z) relative to the sidewall (12), a first cavity (16) confined by the sidewall (12), the outlet (40) and the membrane (30), wherein the first injectable medicament (60) is located in the first cavity (16), a second cavity (18) confined by the sidewall (12), the piston (20) and the membrane (30), wherein the piston (20) and the membrane (30) are separated from each other by a distance along the longitudinal axis (z), wherein the outlet (40) is configured to receive or to hold a needle (50) extending from the distal end (13) into the needle receiving subsection (17), and wherein in an initial configuration, the membrane (30) is located outside the needle receiving subsection (17) and wherein the membrane (30) is displaceable or deformable relative to the sidewall (12) to such an extent that at least a portion (31) of the membrane (30) enters the needle receiving subsection (17).
2. The container (10) according to claim 1, wherein the membrane (30) is pierceable and penetrable by the needle (50).
3. The container (10) according to any one of the preceding claims, wherein at least a second injectable medicament (62) is located in the second cavity (18).
4. The container according to any one of the preceding claims, wherein the membrane (30) is substantially inflexible.
5. The container according to any one of the preceding claims, wherein the membrane (30) comprises at least one or a combination of the following materials: a thermoplastic polymer, a thermoplastic elastomer, a thermoplastic vulcanizate, polyethylene (PE), polyvinyl chloride (PVC), polytetrafluoro-ethylene (PTFE), silicone rubber, halogenated butyl rubber, chlorobutyl rubber, bromobutyl rubber, chemical vapor deposited poly(p-xylylene) polymers, parylene, cork.
6. The container (10) according to any one of the preceding claims, wherein the membrane (30) comprises a thickness in a range from 10 m-2 mm, from 10 m-100 m, from 100 m-2 mm, or from 100 m-1 mm.
7. The container (10) according to any one of the preceding claims, wherein the membrane (30) is substantially impenetrable to liquids.
8. The container (10) according to any one of the preceding claims 3 to 7, wherein the at least first injectable medicament (60) comprises a narcotic active ingredient.
9. The container (10) according to any one of the preceding claims 3 to 8, wherein the first injectable medicament (60) and the second injectable medicament (62) comprise different drug formulations.
10. The container (10) according to any one of the preceding claims 3 to 9, wherein a viscosity of the second injectable medicament (62) is larger than 1.5 mPa s, larger than 3.0 mPa s, larger than 6.0 mPa s, larger than 12.0 mPa s, larger than 20.0 mPa s, or larger than 40 mPa s when measured at room temperature (20 C.).
11. The container (10) according to any one of the preceding claims, wherein the outlet (40) comprises a seal (25) pierceable by the needle (50).
12. An injection device (100) for administering at least a first injectable medicament (60), the injection device (100) comprising a container according to any one of the preceding claims and a needle (50) attached to the outlet (40) of the container (10), wherein the needle (50) comprises a proximal tipped end (51) extending into the needle receiving subsection (17).
13. The injection device according to claim 12, further comprising a plunger (110) configured to exert distally directed pressure to the piston (20).
14. The injection device according to claim 13, wherein the plunger (110) is rigidly connected to the piston (20) to transfer a distally directed and a proximally directed driving force from the plunger (110) to the piston (20).
15. The injection device according to any one of the preceding claims 11 to 14, wherein the needle (50) is displaceable relative to the body (11) of the container (10) along the longitudinal axis (z) between at least two longitudinal positions and wherein the needle (50) is fixable relative to the body (11) in any of the at least two longitudinal positions.
16. The injection device according to any one of the preceding claims 11 to 15, further comprising a housing (120) to accommodate the container (10) and comprising a drive mechanism (104) configured to urge the plunger (110) towards the distal end (13).
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0134] In the following, numerous examples of the container and of an injection device will be described in greater detail by making reference to the drawings, in which:
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DETAILED DESCRIPTION
[0146] In
[0147] The cartridge holder 121 as illustrated in
[0148] The container 10 is arranged inside the cartridge holder 121. It is positionally fixed inside the cartridge holder 121. The container 10 may comprise a narrowing shoulder portion 23 to abut or to engage axially with a correspondingly-shaped shoulder section of the cartridge holder 121. The container 10 comprises an elongated and tubular-shaped body 11. The body 11 may comprise a vitreous body. The body 11 may be made of glass. The body may be translucent or transparent in order to allow visual inspection of the content of the container 10. The elongated body 11 extends along a longitudinal direction (z). The body 11 comprises a distal end 13 and an oppositely located proximal end 14 as illustrated in
[0149] With the distal end the body 11 is arranged near or at the distal end of the cartridge holder 121. The distal end 13 of the body 11 comprises a narrowing shoulder portion 23 extending into a diameter reduced neck portion 22. At the far distal end the neck portion 22 extends into a radially widening head portion 24. At the head portion 24 there is provided a seal 25, e.g. in form of a pierceable sealing disc. This seal 25 may comprise a pierceable rubber septum 26 that is fixed to the head portion 24 and hence to the distal end 13 of the body 11 by means of a crimped cap 27. The seal 25 may form an outlet 40 of the container 10 at the distal end 13 of the elongated body 11.
[0150] The injection device 100 may be further equipped with a drive mechanism 104 comprising a plunger 110 or a piston rod. The drive mechanism 104 may be further equipped with a dose button 108 by way of which a dispensing action of the injection device 100 can be triggered or controlled. Optionally, the injection device 100 and its drive mechanism 104 comprises a dose dial 106 by way of which a size of a dose to be dispensed can be individually set or by way of which the injection device 100 can be deployed or prepared for a subsequent dispensing procedure.
[0151] Optionally and as illustrated in
[0152] As further illustrated in
[0153] The interaction of the container 10 with a pen type injection device 100 as illustrated in
[0154] The container 10 in its entirety is illustrated in
[0155] At a given axial or longitudinal distance from the piston 20 there is arranged a membrane 30 inside the elongated body. The membrane 30 is also sealingly engaged with the sidewall 12 and is at least one of slidable and deformable along the longitudinal axis (z) relative to the sidewall 12. As seen in longitudinal direction the membrane 30 is located between the piston 20 and the seal 40. The membrane 30 may be located in a longitudinal mid-section of the container 10. The piston 20 may be provided at or near a proximal end 14 of the container 10 and the outlet 40 may be provided at the distal end 13.
[0156] The membrane 30 is substantially impenetrable to liquids or is at least substantially impenetrable to pharmaceutically active ingredients of the at least first medicament 60 and/or of an at least second medicament 62. The hollow space 15 inside the body 11 is separated by the membrane 30 into a first cavity 16 and into a second cavity 18. The first cavity 16 is confined by the sidewall 12, by the outlet 40 and by the membrane 30. The second cavity 18 is confined by the sidewall 12, by the piston 20 and by the membrane 30. As seen in longitudinal direction the first and second cavities 16, 18 are located behind one another.
[0157] Adjacent to the distal end and/or adjacent to the outlet 40 the hollow space 15 of the container 10 comprises a needle receiving subsection 17. The needle receiving subsection is defined by the penetration depth of a needle 50 configured to enter the hollow space 15 from the outlet 40 in the longitudinal direction and towards the proximal end 14. The needle receiving subsection 17 is virtually indicated in
[0158] The axial position of the needle 50 may be variable. In an initial configuration and when delivered to a healthcare professional or to a customer the container 10 may be void of a needle. The container 10 may comprise a cartridge sealed towards the distal end 13 by a pierceable seal 25. For conducting an injection procedure the outlet 40 of the container 10 is provided with a double tipped injection needle 50. In alternative examples the needle 50 may undetachably belong to the container 10 and to the body 11. It may be molded into the body 11 and the container 10. Hence, the needle 50 may be in fluid communication with the first cavity 16 when it is commercially distributed to healthcare professionals or end users.
[0159] The second cavity 18 is typically filled with the second injectable medicament 62. Starting from the configuration as shown in
[0160] In
[0161] As further illustrated in
[0162] In the illustration of
[0163] As a consequence, the remaining volume of the first cavity 16 is larger in
[0164] As the dispensing procedure continues the second injectable medicament 62 is urged and expelled through the injection needle 50 until a configuration as exemplary illustrated in
[0165] The container as illustrated in
[0166] Furthermore and according to another aspect the container 10 may be also used for biopsy procedures. It may be then only prefilled with the first injectable medicament 60 located inside the first cavity 16. The second cavity 18 may be substantially empty and may be void of the second injectable medicament 62. For the purpose of conducting a biopsy operation there may be provided a gas between the piston 20 and the membrane 30, which under compression is configured to displace or to deform the membrane 30 towards the distal end 13 in order to expel the first injectable medicament 60 as described above in connection with
[0167] Once the membrane 30 has been penetrated by the proximal end 51 of the needle 50 the piston 20 can be withdrawn and can be displaced or moved towards the proximal end 14 of the body 11 as illustrated in
[0168] In
[0169] The membrane 30 may comprise an elastically deformable material, such as one of several layers of a thermoplastic elastomer. The membrane 30 and its outer circumference may be in frictional engagement with the inside of the sidewall 12. A friction force between the membrane 30 and the sidewall 12 may be substantially larger than a force or pressure required to induce a distally directed deformation of the membrane 30. As the membrane 30 deforms towards the distal end 13 the volume of the first cavity 16 substantially decreases while the volume of the second cavity remains substantially constant. Here, a portion 51, e.g. a radial central portion of the membrane 30 may reach the needle receiving subsection 17 first and may be punctured and penetrated by the proximal tip end 51 of the needle 50 as illustrated in
[0170] As soon as the portion 31 of the membrane 30 is pierced a fluid transferring connection is established between the hollow interior of the needle 50 and the second cavity 18. As the second injectable medicament 62 flows through the needle 50 the fluid pressure inside the second cavity 18 may decrease thus leading to a relaxation of the membrane 30 such that the pierced portion 31 moves in proximal direction and disengages from the needle 50. A further displacement of the piston 20 in distal direction may then repeatedly lead to an expelling of a certain amount of the first injectable medicament 60 from the first cavity 16 until the portion 31 of the membrane 30 will be pierced again. Since the first and the second injectable medicaments 60, 62 will be subject to a mixing in the pierced tissue temporal variations of the order of expelling of the first and the second injectable medicaments 60, 62 might be tolerable.
[0171] Moreover, if the second medicament 62 comprises a comparatively large viscosity and if the diameter of the needle 50 is comparatively small a comparatively high pressure has to be applied to the piston 20 in distal direction. This pressure may be high enough to keep the membrane 30 in the bulged or deformed configuration as illustrated in
[0172] In some examples or embodiments the membrane 30 might be substantially inflexible. It may exhibit a well-defined sliding behavior with regard to the tubular-shaped sidewall 12. In other embodiments the membrane 30 may be in frictional engagement with the sidewall 12 to such an extent that an elastic membrane 30 tends to deform or to bulge towards the distal end 13 as a respective fluid pressure is applied to the membrane 30. The membrane 30 may be flexible as well as stretchable in order to become pierced by the needle 50 as it is deformed towards the distal end 13.
[0173] Depending on the elastic properties of the material the membrane 30 is made of and depending on the overall geometry, e.g. depending on the thickness of the membrane in longitudinal direction and its diameter or cross-section the membrane 30 may be also subject to a combined sliding movement relative to the sidewall 12 as well as to a bulging or deformation due to a comparatively high pressure in the second cavity 18.
LIST OF REFERENCE NUMBERS
[0174] 10 container [0175] 11 elongated body [0176] 12 sidewall [0177] 13 distal end [0178] 14 proximal end [0179] 15 hollow space [0180] 16 first cavity [0181] 17 needle receiving subsection [0182] 18 second cavity [0183] 20 piston [0184] 22 neck portion [0185] 23 shoulder portion [0186] 24 head portion [0187] 25 seal [0188] 26 septum [0189] 27 cap [0190] 30 membrane [0191] 31 portion [0192] 40 outlet [0193] 42 sample fluid [0194] 50 needle [0195] 51 proximal end [0196] 52 distal end [0197] 55 needle assembly [0198] 56 bottom section [0199] 57 sidewall section [0200] 58 threaded section [0201] 60 medicament [0202] 62 medicament [0203] 100 injection device [0204] 104 drive mechanism [0205] 106 dose dial [0206] 108 dose button [0207] 110 plunger [0208] 112 pressure piece [0209] 114 flange [0210] 115 lobe [0211] 116 connection [0212] 120 housing [0213] 121 cartridge holder [0214] 122 body [0215] 123 through opening [0216] 124 cap [0217] 125 window [0218] 126 window [0219] 127 inner needle cap [0220] 128 outer needle cap [0221] 131 socket [0222] 132 thread