DRUG DELIVERY DEVICE

Abstract

Disclosed herein is a drug delivery device with a primary drug delivery assembly for the delivery of a primary medicament, with a primary dose setting member; and a secondary drug delivery assembly for the delivery of a secondary medicament with a secondary dose setting member. A dose dial is rotationally constrained with respect to the housing in a first axial position and is rotationally constrained to the primary dose setting member in a second axial position. A bridging component is axially constrained to the dose dial to set a dose of the secondary medicament, wherein rotation of the dose dial to set a dose of the primary medicament causes the dose dial to move relative to the bridging component in axial direction.

Claims

1. A drug delivery device comprising: a housing retaining a primary drug delivery assembly configured to deliver a primary medicament, wherein the primary drug delivery assembly comprises a primary dose setting member configured to rotate in a helical movement in a proximal direction to set a dose of the primary medicament; and a secondary drug delivery assembly configured to deliver a secondary medicament, wherein the secondary drug delivery assembly comprises a secondary dose setting member configured to move in a proximal direction to set a dose of the secondary medicament, wherein a dose dial movable between a first position and a second position in an axial direction with respect to the primary dose setting member is configured i) to be rotationally constrained with respect to the housing when the dose dial is moved from the first position into the second position when the primary dose setting member is in a zero unit dose position, and ii) to be rotationally constrained to the primary dose setting member and free to rotate relative to the housing when the dose dial is in the second position, and wherein a bridging component is axially constrained to the secondary dose setting member and is coupled to the dose dial such that the bridging component is axially constrained to the dose dial when the dose dial is moved from the first position into the second position such that the dose of the secondary medicament is set, and such that rotation of the dose dial in the second position to set a dose of the primary medicament causes the dose dial to move relative to the bridging component in the axial direction.

2. The drug delivery device according to claim 1, wherein the dose dial is configured as a sleeve that at least partly surrounds the primary dose setting member.

3. The drug delivery device according to claim 1, wherein the dose dial is axially splined to the housing in the first position and is splined to the primary dose setting member in the second position.

4. The drug delivery device according to claim 1, wherein the dose dial has an outer thread extending helically in the axial direction and wherein the bridging component is in threaded engagement with the outer thread of the dose dial.

5. The drug delivery device according to claim 1, wherein the secondary drug delivery assembly comprises a spring configured to bias the secondary dose setting member in a proximal direction.

6. The drug delivery device according to claim 1, wherein a stop is provided to limit axial travel of the bridging component in a proximal direction, and wherein the bridging component is configured to reach the stop when the dose dial reaches the second position.

7. The drug delivery device according to claim 1, comprising a primary medicament cartridge and a secondary medicament cartridge, wherein the primary medicament cartridge is coupled to the primary drug delivery assembly and the secondary medicament cartridge is coupled to the secondary drug delivery assembly, and wherein the primary medicament cartridge and the secondary medicament cartridge respectively contain a medicament.

8. The drug delivery device according to claim 1, wherein the drug delivery device is configured as a disposable device.

9. The drug delivery device according to claim 1, wherein the secondary drug delivery assembly comprises a drive sleeve releasably connected to the secondary dose setting member and threaded to a piston rod such that pure axial motion of the drive sleeve causes the piston rod to rotate, wherein the piston rod is in threaded engagement with the housing or a housing insert, and wherein a clicker spring is provided to rotationally lock the drive sleeve for dose dispensing, the clicker spring configured to be rotationally locked to the housing when a predetermined minimum dose of the secondary medicament is set.

10. The drug delivery device according to claim 1, comprising a dose button arranged in the dose dial such that displacement of the dose button in a distal direction causes the dose dial to move in a distal direction from the second position into the first position, and such that when the dose dial is in the first position, the dose button engages a dispense button of the primary drug delivery assembly such that further movement of the dose button causes a set dose of the primary medicament to be dispensed.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0114] Non-limiting, exemplary embodiments of the disclosure will now be described with reference to the accompanying drawings, in which:

[0115] FIG. 1 shows an example of a drug delivery device (e.g., a dual cartridge drug delivery device) in accordance with an embodiment of the disclosure in a perspective view with parts removed; and

[0116] FIG. 2 shows a distal section of a secondary drug delivery assembly of the drug delivery device of FIG. 1 in accordance with an embodiment of the disclosure.

DETAILED DESCRIPTION

[0117] FIG. 1 shows the interior of an example drug delivery device 1 comprising a primary drug delivery assembly 2 and a secondary drug delivery assembly 3, both retained in a housing 4. The primary drug delivery assembly 2 serves for the delivery of a primary medicament contained in a primary cartridge 5. The secondary drug delivery assembly 3 serves for the delivery of a secondary medicament contained in a secondary cartridge 6. The cartridges may also be retained in a cartridge holder that is attachable to the distal end of the device 1. The cartridge holders for the cartridges may be integrated in a single cartridge holder hub.

[0118] At the distal end of the assembly, a 2-1 needle adapter 7 is attached. At the distal end 8 of the needle adaptor 7 a screw thread is formed. An injection needle can be attached to said screw thread or injection. The injection needle is in fluid communication with two proximally oriented needles in the needle adapter 7 that pierce respective septa of the respective medicament cartridge 5 and 6. The device 1 extends from the distal end 8 to a proximal end 9.

[0119] The construction of the two drug delivery assemblies 2, 3 may be similar or the same (e.g., as shown in the illustrated example). The primary drug delivery assembly 2 comprises a primary housing, housing body or housing section 10, a primary dose setting member 11 in the form of a dose dial sleeve, which is threadedly engaged with a threaded insert 17 fixed in the primary housing section 10 so that when the primary dose setting member 11 is rotated, it moves along a helical pattern in axial direction. The primary dose setting member 11 is connected to a dose dial 12, which is configured as a dial collar and which assembles as a sleeve over the primary drug delivery assembly 2.

[0120] The dose 12 is movable between a first distal axial position and a second proximal axial position relative to the primary dose setting member 11. The dose dial 12 is rotationally constrained with respect to the housing 4 when in the first position and when the dose setting member 11 is in its most distal position, which corresponds to a set dose of zero units. For that purpose, the housing 4 has on its inner surface a number of axially extending splines (not shown) or an axially extending flexing rib engaging a spline or a number of splines on the dose dial 12. When the dose dial 12 is moved proximally in axial direction, it disengages from the splined connection with the housing 4 and engages with a corresponding spline connection provided on the dial sleeve (primary dose setting member) 11 so that the dose dial 12 is rotationally constrained to the primary dose setting member 11. Rotation of the dose dial 12 is then transferred to the primary dose setting member 11. The primary dose setting member 11 is usually rotated (in a first rotational direction) to set an increasing dose of the primary medicament. When the dose dial 12 is in the second position, a dose of the primary medicament is set by rotating the dose dial 12. The dose dial 12 and the primary dose setting member 11 displace in proximal direction in a helical movement.

[0121] Inside the primary drug delivery assembly 2, there is a dose dispense mechanism including a clutch 13, a piston rod and a drive sleeve 14. For dispense a dose button 15 is pressed. The dose button 15 is urged in proximal direction 9 by a spring (not shown) away from a dispense button (not shown) of the primary drug delivery assembly 2.

[0122] When a dose of a primary medicament has been set, the dose button 15 is pressed so that the dose button acts on the dispense button of the primary drug delivery assembly. The dispense button acts on the clutch mechanism between the primary drive sleeve 14 and the primary dose setting member 11 which is disengaged and the primary dose setting member 11 is forced to move in distal direction in a pure axial motion thereby rotating the piston rod located inside. As the piston rod is in threaded engagement with a housing insert, the piston rod displaces in distal direction thereby displacing a bung in the cartridge so that the set dose of the primary medicament is dispensed.

[0123] The inner structure of the secondary drug delivery assembly 3 can be similar to that of the primary drug delivery assembly 2. In the illustrated example, the inner structure of the secondary drug delivery assembly 3 is very similar to that of the primary drug delivery assembly 2. The secondary drug delivery assembly 3 also comprises a secondary dose setting member 16 that is in threaded engagement with a threaded insert 18 fixed in a secondary housing, housing section or housing body.

[0124] Located distally (in dispensing direction) from the secondary dose setting member 16, a secondary drive sleeve 19 is located, which is in threaded engagement with the secondary piston rod 20. A clutch 21 is disposed between the secondary drive sleeve 19 and the secondary dose setting member 16. At the proximal end of the secondary drug delivery assembly 3, a secondary dose dial grip 22 is rotationally constrained to the secondary dose setting member 16. The secondary dose dial grip 22 is rotationally and axially constrained to cap member 23, that is axially constrained to a bridging component 24 but which can rotate relative thereto. The bridging component 24 is axially guided inside the housing 4 by means of a splined groove connection (not shown). The bridging component 24 surrounds the dose dial 12 and has on an inner surface an inner thread which engages an outer thread 25 on the dose dial 12 so that the bridging component 24 and the dose dial 12 are in threaded engagement 25a. Rotation of the dose dial 12 relative to the bridging component 24 causes relative axial displacement thereof.

[0125] In order to seta dose, the user is forced to follow specific steps. As the dose dial 12 is blocked rotationally within the housing 4 until it is pulled upwards (proximally) from the first position into the second position relative to the primary dose setting member 11, the user has to pull the dose dial 12 in proximal direction. That causes the splined engagement with the housing 4 to be removed. Thereafter, the dose dial 12 can be rotated wherein this rotation is transmitted to the primary dose setting member 11 such that a dose of the primary medicament is set. When the dose dial 12 is pulled in proximal direction, the bridging component 24 moves with the dose dial 12 by virtue of its threaded engagement in proximal direction.

[0126] This pull-to-activate user step forces the secondary dose setting member 16 to move in proximal direction as well. The secondary dose setting member 16 can rotate relative to the bridging component 24. As the secondary dose setting member 16 travels proximally, a dose of the secondary medicament is set. As the dose of the secondary medicament is set, a dose of the primary medicament is not set because the dose dial 12 moves from its first position to its second position without rotating or moving the primary dose setting member 11 in proximal direction. When the dose dial 12 reaches its second position, the dose dial 12 is free to rotate. A stop 26 abuts the bridging component 24 so that the bridging component 24 cannot be displaced further in proximal direction. In the second position, which corresponds to the abutment of the bridging component 24 at the stop 26, the dose dial 12 is free to rotate. The user is now allowed to rotate the dose dial 12 to set an increasing dose of the primary medicament. Rotation of the dose dial 12 does not cause displacement of the bridging component 24 in proximal direction so that there is no further dose setting in the secondary drug delivery assembly 3.

[0127] The device in FIG. 1 has a modification in the secondary drug delivery assembly 3 in comparison to the primary drug delivery assembly 2. A compression spring 27 urges the secondary drive sleeve 19 in proximal direction and automatically pushes the secondary drive sleeve 19 and accordingly the secondary dose setting member 16 in proximal direction when the dial grip 12 is pulled proximally. This feature allows application of a detent action (not shown) to retain the dose dial 12 until the user applies some axial force. Thereafter, the spring 27 sends the mechanism to the set stop 26 so that the device is ready for dialing the variable dose of the primary medicament.

[0128] The depression of the dose button 15 displaces the dose dial 12 and in turn the bridging component 24. The spring that urges the dose button in proximal direction applies a force in that is stronger than a force that is required to displace the bridging component 24. Movement of the bridging component 24 in distal direction acts on a dispense button in the secondary drug delivery assembly 3. This declutches the clutch mechanism in the secondary drug delivery assembly 3 so that dispense of the secondary medicament is initiated.

[0129] The dose button 15 reaches the primary dispense button, when the bridging component 24 is moved to its original initiate position. Then the dose button 15 engages the primary dispense button and initiates dispense of the primary medicament by declutching the clutch inside the primary drug delivery assembly 2. Further displacement of the dose dial 12 by depressing the dose button 15 causes the primary dose setting member 11 to rotate back in distal direction thereby dispensing the primary medicament. Accordingly, the fixed dose of the secondary medicament is dispensed prior to the variable dose of the primary medicament. The dose dial rotates through the thread engagement 25a with the bridging component and moves relative to the bridging component in distal direction.

[0130] FIG. 2 shows a part of the secondary drug delivery assembly 3 of FIG. 1, with the inner clutch 21, the secondary drive sleeve 19, a clicker spring 28 and a vertical rib 29 provided on the secondary housing. During the setting of a dose in the secondary drug delivery assembly 3, the clicker spring 28 rotates with the clutch 21. The spring is in clearance during a full 180-rotation and comes to rest aligned with the vertical rib 29. When the user now commits to dispense a dose, the clutch 21 is displaced compressing the spring 28. This causes the spring 28 to become rotationally locked-out against the vertical rib 29. For the axial travel of the clutch 21, the spring 28 and the secondary drive sleeve 19 advance the piston rod in the manner as described above.

REFERENCE NUMERALS

[0131] 1 drug delivery device [0132] 2 primary drug delivery assembly [0133] 3 secondary drug delivery assembly [0134] 4 housing [0135] 5 primary cartridge [0136] 6 secondary cartridge [0137] 7 needle adapter [0138] 8 distal end [0139] 9 proximal end [0140] 10 primary housing [0141] 11 primary dose setting member (primary dose dial sleeve) [0142] 12 dose dial [0143] 13 primary clutch [0144] 14 primary drive sleeve [0145] 15 dose button [0146] 16 secondary dose setting member [0147] 17 threaded insert of the primary drug delivery assembly [0148] 18 threaded insert of the secondary drug delivery assembly [0149] 19 secondary drive sleeve [0150] 20 secondary piston rod [0151] 21 secondary clutch [0152] 22 secondary dose dial grip [0153] 23 cap member [0154] 24 bridging component [0155] 25 outer thread on dose dial [0156] 25a threaded engagement [0157] 26 stop [0158] 27 compression spring [0159] 28 clicker spring [0160] 29 vertical rib