Injection Device and Container for an Injection Device
20210220560 ยท 2021-07-22
Inventors
Cpc classification
A61M5/3221
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
A61M5/2422
HUMAN NECESSITIES
A61M2005/323
HUMAN NECESSITIES
A61M2005/3231
HUMAN NECESSITIES
International classification
A61M5/24
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
A61M5/315
HUMAN NECESSITIES
Abstract
In one aspect the present disclosure relates to an injection device. The injection device includes a housing configured to receive a container; a drive mechanism having a plunger configured to urge against a bung in the container in a distal direction to expel the dose of the medicament from the container, wherein the plunger is configured to releasably connect to the bung to form a plunger bung assembly; a container moving mechanism configured to move the container relative to the housing between a proximal replacement position and a distal injection position; at least one retainer configured to prevent a proximally directed movement of the container relative to the housing. The drive mechanism is configured to retract the plunger and the plunger bung assembly along the proximal direction relative to the tubular barrel of the container.
Claims
1-15. (canceled)
16. An injection device for injecting of a dose of a liquid medicament, the injection device comprising: a housing configured to receive a container, wherein the container comprising a tubular barrel filled with the liquid medicament is sealed by a bung in a proximal direction, and wherein the bung is slidably arranged inside the tubular barrel; a drive mechanism having a plunger configured to urge against the bung in a distal direction to expel the dose of the liquid medicament from the container, wherein the plunger is configured to releasably connect to the bung to form a plunger bung assembly; a container moving mechanism configured to move the container relative to the housing between a proximal replacement position and a distal injection position; and at least one retainer configured to prevent a proximally-directed movement of the container relative to the housing, wherein the drive mechanism is configured to retract the plunger and the plunger bung assembly along the proximal direction relative to the tubular barrel of the container.
17. The injection device according to claim 16, wherein the at least one retainer comprises a distal retainer configured to retain the container in the distal injection position.
18. The injection device according to claim 17, wherein the distal retainer is de-activatable to allow the proximally-directed movement of the container relative to the housing towards the proximal replacement position.
19. The injection device according to claim 16, wherein the at least one retainer comprises a proximal retainer configured to retain the container in the proximal replacement position.
20. The injection device according to claim 16, wherein the plunger comprises a connector to releasably connect with a counterpart connector of the bung.
21. The injection device according to claim 16, wherein the container moving mechanism is configured to slidably displace the container between the proximal replacement position and the distal injection position, and wherein the container moving mechanism comprises a drive to induce or to control a motion of the container relative to the housing.
22. The injection device according to claim 21, wherein the drive is provided by the plunger connected to the bung and movable relative to the housing.
23. The injection device according to claim 16, further comprising the container arranged inside the housing.
24. The injection device according to claim 23, wherein the container comprises a needle holder configured to hold an injection needle, and wherein the needle holder is retractable inside the tubular barrel.
25. The injection device according to claim 24, wherein the bung comprises a connector facing towards the needle holder, wherein at least one of the needle holder or the injection needle comprises a counterpart connector facing towards the bung, and wherein the connector and the counterpart connector are configured to form a mechanical interconnection between the bung and the needle holder.
26. The injection device according to claim 24, wherein the needle holder comprises a seal in fluid tight engagement with the tubular barrel of the container.
27. A container for a liquid medicament, the container comprising: a tubular barrel; a bung sealing a proximal end of the tubular barrel, wherein the bung comprises a connector facing towards a distal end of the tubular barrel; and a needle holder configured to hold an injection needle and retractable inside the tubular barrel, wherein the needle holder comprises a seal in fluid tight engagement with the tubular barrel, wherein at least one of the needle holder or the injection needle comprises a counterpart connector configured to engage with the connector to form a mechanical interconnection with the bung.
28. The container according to claim 27, wherein the needle holder comprises a socket configured to protrude axially through an orifice at a distal end of the tubular barrel, and wherein the socket comprises an outer thread to engage with an inner thread of a cup-shaped needle assembly.
29. The container according to claim 28, wherein the needle holder comprises a radially widening shoulder portion axially adjacent to the socket.
30. The container according to claim 27, further comprising a rotation lock configured to prevent a rotation between the needle holder and the tubular barrel, wherein the rotation lock comprises at least one radial protrusion configured to engage with at least one complementary-shaped radial recess.
31. The container according to claim 30, wherein the at least one radial protrusion is located on one of the needle holder and the tubular barrel, and the at least one complementary-shaped radial recess is located on the other of the needle holder and the tubular barrel.
32. The container according to claim 30, wherein the at least one radial protrusion faces inwardly from an inwardly facing circumference of a flange confining an orifice of the tubular barrel, and the at least one complementary-shaped radial recess is located on an outer surface of the needle holder.
33. The container according to claim 30, wherein the at least one radial protrusion and the at least one complementary-shaped radial recess extend in a longitudinal direction.
34. A method of exchanging a medicament container in an injection device, the method comprising: retracting a needle holder into a barrel of the medicament container; moving the medicament container relative to a housing of the injection device from a distal injection position into or towards a proximal replacement position; providing access to the medicament container after the needle holder and/or after the medicament container has been moved to the proximal replacement position; and removing the medicament container from the housing and inserting another medicament container into the housing.
35. The method according to claim 34, wherein moving the medicament container relative to the housing of the injection device from the distal injection position into or towards the proximal replacement position comprises moving the medicament container relative to the housing towards and into the proximal replacement position while the needle holder remains stationary relative to the barrel of the medicament container.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0133] In the following, numerous examples of the medicament 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
[0152] In the sequence of
[0153] After completion of the injection procedure the injection device 10 is configured to retract and to withdraw the injection needle from the skin of the patient and to retract the needle inside the housing 11 of the injection device 10. The injection device 10 is configured to receive a container 30 having a tubular-shaped barrel 31 filled with a liquid medicament 5. The housing 11 comprises a proximal end and an oppositely located distal end 2. In
[0154] In an initial configuration as illustrated in
[0155] The injection device 10 further comprises a drive mechanism 12 having at least a plunger 14 being moveable along the axial direction, hence towards the distal direction 2 and towards the proximal direction 3 relative to the housing 11. The drive mechanism 12 may be all mechanically implemented. It may be driven by a mechanical energy reservoir, such as a spring. With other examples the drive mechanism 12 may comprise an electromechanical drive and may be electrically controlled, e.g. by a control 7 of the injection device 10. Moreover, the injection device comprises a dose setting member 8 and a trigger 9. By means of the dose setting member 8 at least the size of a dose or other dosing parameters, such as the injection velocity may be modified or set. By means of the trigger a dose dispensing action can be initiated and/or controlled or prematurely interrupted if required.
[0156] The injection device further comprises a container moving mechanism 20 by way of which the container 30 can be moved relative to the housing 11 between a proximal replacement position P as illustrated in
[0157] The plunger 14 comprises a connector 24 located at a distal end of the plunger 14 and hence facing towards a proximal end of the bung 32. The bung 32 comprises a counter connector 34 complementary or correspondingly-shaped to the connector 24 of the plunger 14. The counter connector 34 is located at a proximal side of the bung 32 and faces towards the proximal direction 3. The connector 24 and the complementary shaped counter connector 34 are configured to releasably connect to form a plunger bung assembly 15 as illustrated in
[0158] The mutual interconnection between the plunger 14 and the bung 32 is tension stable and exhibits a tensile strength that is larger than a friction force required for moving the bung 32 relative to the barrel 31. The interconnection between the plunger 14 and the bung 32 may be of load limiting type. If for instance a proximally directed movement of the bung 32 is impeded or blocked and if the plunger 14 exerts a tensile stress to the bung 32 exceeding the predefined maximum load the interconnection between the plunger 14 and the bung 32 abrogates. The container moving mechanism 20 may comprise a sliding mechanism to slidably support the medicament container 30 inside the housing 11.
[0159] In
[0160] The distally directed motion and displacement of the medicament container 30 into the distal injection position D is governed or conducted by at least one of the drive mechanism 12 and a separate drive 21 of the container moving mechanism 20. The drive 21 is only optional. Generally, the drive mechanism 12 and the plunger 14 may be operable to displace the container 30 into the distal injection position. Here, the container moving mechanism 20 is constituted by the drive mechanism 12 and the plunger 14 connected to the bung 32. The plunger 14 can be driven in distal direction 2 until it gets in abutment with the bung 32. The friction force between the bung 32 and the inside surface of the tubular barrel 31 is typically larger than a force required for moving the container 30 from the proximal replacement position P towards and into the distal injection position D. The friction force between the bung 32 and the barrel 31 may be even larger than a force required for piercing the skin 4 by the needle 41.
[0161] In
[0162] If a last dose of the medicament 5 has been dispensed the bung 32 reaches a distal most position inside the barrel 31 as illustrated in
[0163] In order to prevent a premature proximally directed movement of the container 30 from the distal injection position D towards the proximal replacement position P the injection device 10 comprises a distal retainer 16. The distal retainer 16 is configured to get in axial abutment with at least a portion, e.g. with a proximally facing flange or with an end face of the barrel 31 of the medicament container 30. As illustrated in
[0164] The distal retainer 16 is at least temporally deactivatable to allow and to support a proximally directed movement or retraction of the container 30 relative to the housing 11 towards the proximal replacement position P. After termination of a last injection from the container 30 as indicated in
[0165] Thereafter, the distal retainer 16 is deactivated or released so as to allow and to support a proximally directed movement of the container 30 towards and into the proximal replacement position P. The housing 11 may comprise a closure 25, e.g. equipped with a lid providing access to the container 30 only when the container 30 is in the proximal replacement position P. The closure 25 may be limited in size and may be only slightly larger than the barrel 31 of the cartridge. In this way and as long as the needle 41 protrudes from the distal end 35 of the barrel 31 the container 30 may be hindered from removal of the housing 11.
[0166] The sequence of
[0167] With the example of
[0168] The hollow and cannula type injection needle 41 comprises a distal tipped end and further comprises a counterpart connector 44 at its proximal end. The counterpart connector 44 may comprise a bulged shape to interconnect with the connector 36 located at the distal side of the bung 32. As illustrated in
[0169] As illustrated further in
[0170] As illustrated in
[0171] Once arrived at the proximal replacement position P as illustrated in
[0172] When arriving in the proximal replacement position P as illustrated in
[0173] After applying such excessive force to the plunger 14 in proximal direction 3 the plunger 14 disconnects from the bung 32 and hence from the container 30. The container 30 can then be removed or replaced by another container.
[0174] In
[0175] The sequence of the steps 100 and 102 may also be exchanged or the steps 100 and 102 may be conducted at a certain temporal overlap. The steps 100 and 102 may even be conducted simultaneously. With either step 100 or 102 the injection needle 41 still penetrating the skin 4 of a patient after completion of the injection procedure is withdrawn from the skin 4 of the patient.
[0176] For the method it is generally sufficient when only step 100 is performed so that the needle holder 40 is retracted into the barrel 31 of the medicament container 30. Step 102 may be only optional. After the needle holder 40 has been retracted into the barrel 31 in step 103 there is provided access to the medicament container 30 which is still located inside the housing 11 of the injection device 10. In a subsequent step 104 the medicament container 30 is removed from the housing 11 and in the further step 105 another medicament container 30 is inserted into the housing 11 of the injection device 10. Thereafter, subsequent dose setting and injection procedures may take place with the new medicament container.
[0177] In
[0178] The needle holder 140 comprises a step down socket portion 146 at its distal end protruding through an orifice 137 at a distal end 135 of a barrel 131 of the medicament container 130. The orifice 137 and the distal end 135 are laterally confined by a radially inwardly extending flange 139 protruding radially inwardly from a sidewall of the barrel 131. In the initial configuration as illustrated in
[0179] In
[0180] The needle holder 140 comprises a radially widened shoulder section 143 proximally adjacent to the threaded socket 146. The needle holder 140 further comprises an axial mid-section 149 located axially between the shoulder portion 143 and the threaded socket 146. The cross-section or diameter of the mid-section 149 matches with the inner diameter of the orifice 137 of the barrel 131. The outer circumference of the seal 142 and hence of the shoulder section 143 matches with the inner circumference or inner cross-section of the sidewall of the barrel 131 and the threaded socket 146 is reduced in diameter compared to the inner cross-section of the orifice 137. The diameter reduction of the threaded socket 146 compared to the mid-section 149 matches with the radial thickness of the threaded engagement of the threaded socket 146 with the cupped receptacle 152.
[0181] In this way, the needle assembly 150 in threaded engagement with the threaded socket 146 can be retracted together with the needle holder 140 in proximal direction 3 into the barrel 131 of the container 130.
[0182] The channel section 147 comprises a snap feature thus forming a counterpart connector 144 to engage with a connector 136 of the bung 132. The bung 132 comprises a counterpart connector 134 that is substantially identical to the counterpart connector 34 as illustrated and described in connection with
[0183] The mutually corresponding snap features 136a, 144a comprise beveled structures facing in distal direction 2 so as to facilitate establishing of a mechanical connection between the bung 132 and the needle holder 140. A withdrawal force for disconnecting the bung 132 and the needle holder 140 is therefore substantially larger than a force required for establishing the snap fit engagement of the connector 136 and the counterpart connector 144.
[0184] In
[0185] The radial protrusion 161 is located on one of the barrel 131 and the needle holder 140, wherein the complementary shaped radial recess 162 is located on the other one of the barrel 131 and the needle holder 140. In the illustration of
[0186] As long as the at least one protrusion 161 and the at least one recess 162 are in mechanical engagement the needle holder 140 is rotationally fixed to the barrel 131. A user may then attach a needle assembly 150 to the threaded socket 146 protruding from the distal end 135 of the barrel 131. The rotational interlock between the barrel 131 and the needle holder 140 is of particular benefit to enable a screwing connection between the needle assembly 150 and the needle holder 140.
[0187] As illustrated in
LIST OF REFERENCE NUMBERS
[0188] 2 distal direction [0189] 3 proximal direction [0190] 4 skin [0191] 5 medicament [0192] 7 control [0193] 8 dose setting member [0194] 9 trigger [0195] 10 injection device [0196] 11 housing [0197] 12 drive mechanism [0198] 14 plunger [0199] 15 plunger bung assembly [0200] 16 retainer [0201] 18 retainer [0202] 19 through opening [0203] 20 container moving mechanism [0204] 21 drive [0205] 22 drive [0206] 24 connector [0207] 24a head portion [0208] 24b neck portion [0209] 25 closure [0210] 26 orifice [0211] 27 flange [0212] 28 distal end [0213] 30 container [0214] 31 barrel [0215] 32 bung [0216] 33 proximal end [0217] 34 counterpart connector [0218] 34a flange portion [0219] 34b receptacle [0220] 35 distal end [0221] 36 connector [0222] 36a, b, c, d wings [0223] 37 orifice [0224] 38 cap [0225] 39 flange [0226] 40 needle holder [0227] 41 injection needle [0228] 42 seal [0229] 43 shoulder portion [0230] 44 counterpart connector [0231] 46 socket [0232] 130 container [0233] 131 barrel [0234] 132 bung [0235] 133 proximal end [0236] 134 counterpart connector [0237] 135 distal end [0238] 136 connector [0239] 136a snap feature [0240] 137 orifice [0241] 139 flange [0242] 140 needle holder [0243] 141 injection needle [0244] 142 seal [0245] 143 shoulder portion [0246] 144 counterpart connector [0247] 145 pierceable closure [0248] 146 threaded socket [0249] 147 channel section [0250] 148 outer thread [0251] 149 mid-section [0252] 150 needle assembly [0253] 152 receptacle [0254] 154 inner thread [0255] 160 rotational lock [0256] 161 protrusion [0257] 162 recess