DOSING SYSTEM FOR AN INJECTION DEVICE
20220047817 · 2022-02-17
Inventors
Cpc classification
A61M5/31583
HUMAN NECESSITIES
A61M5/31551
HUMAN NECESSITIES
A61M5/31541
HUMAN NECESSITIES
International classification
Abstract
An injection device for dispensing a dose of a product by manually advancing a piston rod includes a dosing and dispensing mechanism having a housing with a longitudinal axis, a dosing sleeve mounted in the housing for adjusting and correcting the dose, a housing insert fixed to the housing and arranged inside the dosing sleeve, and a coupling sleeve mounted in the housing for driving the piston rod. For setting and correcting a dose, the dosing sleeve is rotatable relative to the coupling sleeve, and for dispensing the dose, the dosing sleeve can be coupled to the coupling sleeve in a rotationally fixed manner. In this case, the coupling sleeve has a locking element which can interact with the housing insert so that the coupling sleeve can be rotated in a first direction of rotation and cannot be rotated in a second direction of rotation relative to the housing insert.
Claims
1. An injection device for dispensing a dose of a product by manually advancing a piston rod into a cartridge held in the injection device, the injection device comprising a dosing and dispensing mechanism comprising: a housing having a longitudinal axis; a dosing sleeve at least partially arranged in the housing for dose setting and dose correcting; a housing insert fixed to the housing and at least partially arranged within the dosing sleeve; and a coupling sleeve at least partially arranged within the housing for driving the piston rod, wherein for dose setting and dose correcting, the dosing sleeve is rotatable relative to the coupling sleeve, and for dispensing the dose, the dosing sleeve is coupleable to the coupling sleeve and rotatably fixed relative thereto, and wherein the coupling sleeve comprises a locking element cooperable with the housing insert such that the coupling sleeve is rotatable relative to the housing insert in a first direction of rotation and is prevented from rotation in an opposite, second direction of rotation.
2. The injection device according to claim 1, wherein the locking element comprises an elastic radial arm.
3. The injection device according to claim 2, wherein the elastic radial arm is arranged in a lateral surface of the coupling sleeve.
4. The injection device according to claim 1, wherein the housing insert comprises axial grooves cooperable with the locking element.
5. The injection device according to claim 1, wherein the housing insert comprises an external thread, and wherein the dosing sleeve is in a threaded engagement with the external thread of the housing insert.
6. The injection device according to claim 1, wherein the coupling sleeve comprises an elastic click element coupleable with the dosing sleeve for generating an acoustic and/or tactile signal during dose setting and dose correcting in the first direction of rotation and the second direction of rotation.
7. The injection device according to claim 1, wherein the coupling sleeve is rotationally fixed relative to and displaceably mounted on the piston rod.
8. The injection device according to claim 7, wherein the coupling sleeve comprises an internal axial web and the piston rod comprises an external axial groove engagable in the axial web.
9. The injection device according to claim 1, wherein the coupling sleeve comprises a first part cooperable with the piston rod and a second part coupleable to the dosing sleeve, wherein the first part and the second part are displaceable and rotationally fixed relative to one another.
10. The injection device according to claim 9, wherein the first part is rotationally fixedly mounted to and displaceable relative to the piston rod, and wherein the second part is sleeve-shaped and surrounds the first part.
11. The injection device according to claim 1, wherein the locking element is formed as one of a pawl element or a counter-pawl element and the housing insert comprises the other of a pawl element or a counter-pawl element, wherein the pawl element and the counter-pawl element form a ratchet such that the coupling sleeve is rotatable relative to the housing insert in a dispensing direction and is non-rotatable in an opposite direction.
12. A dosing and dispensing mechanism for an injection device for dispensing a dose of a product by advancing a piston rod, the dosing and dispensing mechanism comprising: a housing having a longitudinal axis; a dosing sleeve at least partially arranged in the housing for dose setting and dose correcting; a housing insert fixed to the housing and at least partially arranged within the dosing sleeve; and a coupling sleeve at least partially arranged within the housing for driving the piston rod, wherein for dose setting and dose correcting, the dosing sleeve is rotatable relative to the coupling sleeve in a first direction and in an opposite, second direction, and for dispensing the dose, the dosing sleeve is coupleable to the coupling sleeve and rotatably fixed relative thereto, and wherein the coupling sleeve comprises a locking element cooperable with the housing insert such that the coupling sleeve is rotatable relative to the housing insert in the first direction of rotation and is prevented from rotation the second direction of rotation.
13. The dosing and dispensing mechanism according to claim 12, wherein the housing insert comprises axial grooves cooperable with the locking element, and wherein the locking element and the axial grooves form a ratchet such that the coupling sleeve is rotatable relative to the housing insert in the first direction corresponding to a dispensing direction and is non-rotatable in the second direction.
14. The dosing and dispensing mechanism according to claim 13, wherein the coupling sleeve is rotationally fixed relative to and displaceably mounted on the piston rod.
15. The injection device according to claim 14, wherein the locking element comprises an elastic radial arm arranged in a lateral surface of the coupling sleeve.
16. A dosing and dispensing mechanism for an injection device for dispensing a dose of a product by advancing a piston rod, the dosing and dispensing mechanism comprising: a housing having a longitudinal axis; a dosing sleeve at least partially arranged in the housing for dose setting and dose correcting; a housing insert fixed to the housing and at least partially arranged within the dosing sleeve; and a coupling sleeve at least partially arranged within the housing for driving the piston rod, wherein for dose setting and dose correcting, the dosing sleeve is rotatable relative to the coupling sleeve in a first direction and in an opposite, second direction, and for dose dispensing, the dosing sleeve is coupleable to the coupling sleeve and rotatably fixed relative thereto, wherein the coupling sleeve comprises a locking element cooperable with the housing insert such that the coupling sleeve is rotatable relative to the housing insert in the first direction of rotation and is prevented from rotation in the second direction of rotation, and wherein the coupling sleeve is rotationally fixed relative to and displaceably mounted on the piston rod such that rotation of the coupling sleeve during dose dispensing causes the piston rod to rotate to thereby advance and dispense the dose.
17. The injection device according to claim 16, wherein the locking element comprises an elastic radial arm.
18. The injection device according to claim 17, wherein the elastic radial arm is arranged in a lateral surface of the coupling sleeve.
19. The injection device according to claim 16, wherein the housing insert comprises axial grooves cooperable with the locking element.
20. The injection device according to claim 16, wherein the coupling sleeve comprises an internal axial web and the piston rod comprises an external axial groove engagable in the axial web.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0044] In connection with the attached figures, implementations of the present disclosure are described herein and are intended to show basic possibilities and are in no way to be construed restrictively.
[0045]
[0046]
[0047]
[0048]
[0049]
[0050]
[0051]
DETAILED DESCRIPTION
[0052]
[0053] In
[0054] The structural features of the individual components of the injector 1 are discussed in detail as follows. The function, in particular the setting, correction and discharge of a dose, is described thereafter.
[0055] The cartridge holder 12 may be snapped to the housing 10 at a distal end of the housing 10 in a rotationally fixed and axially fixed manner by means of a snap-fit connection. The cartridge holder 12 may support the cartridge 13 and may have a connecting element at its distal end to which an injection needle (not shown) may be attached.
[0056] The outer housing sleeve 14 may be cylindrical in shape. In a proximal region, a radial aperture or opening 16 may be formed in the jacket of the housing sleeve 14. Through this opening 16, a numerical scale of the dosing sleeve 30 may be read from the outside.
[0057] Furthermore, the outer housing sleeve 14 may include ribs 17 at the distal end on the inner side distributed over the circumference and projecting radially towards the center, for example as shown in
[0058] The inner housing sleeve 20 may have a cylindrical shape and may be coaxial with the outer housing sleeve 14. By means of catches which engage in a wall on the inside of the outer housing sleeve 14, the inner housing sleeve 20 may be snapped onto the outer housing sleeve 14 both in the axial direction and rotationally immovably relative thereto. In a distal region, such as through an inner base, the inner housing sleeve 20 may include an internal thread 21 in which the piston rod 70 may be screwed in, as shown in
[0059] On its outer side, the inner housing sleeve 20 may include an external thread 23 onto which the dosing sleeve 30 may be screwed. At the distal end and at the proximal end of the external thread 23, an axially aligned web or shoulder 24, 25 may be formed in each case. In the fully screwed-in position of the dosing sleeve 30, a stop (not shown) in the dosing sleeve 30 may strike the distal web or shoulder 24 so that the minimum dose or screw movement of the dosing sleeve 30 into the housing may be limited by the distal web or shoulder 24. The maximum dose or screw movement of the dosing sleeve 30 out of the housing 10 may be limited by the proximal web or shoulder 25. As a result, the rotatable inner housing sleeve 20 may support the dosing sleeve 30 relative to the housing 10.
[0060] The dosing sleeve 30 may be in the form of a hollow cylinder or sleeve and may have an area at the proximal end with a diameter which may be larger than the remaining area of the dosing sleeve 30 and which may serve as a handle 33 for rotating the dosing sleeve 30. This handle 33 may not fit into the housing 10 but, as can be seen in
[0061] As mentioned, the dosing sleeve 30 may be in a threaded connection with the inner housing sleeve 20. For this purpose, the dosing sleeve 30 may include an internal thread 31 on its inner side in a distal region. In a central region, the dosing sleeve 30 may include on its inner side a plurality of axial grooves 32 (
[0062] At the transition of the dosing sleeve 30 from the region of the smaller diameter to the region of the larger diameter, e.g., where the handle 33 is formed, an annular surface may be provided inside the dosing sleeve 30 which may be at right angles to the longitudinal axis. On this surface circumferential axial teeth 34 may be arranged, which may be connected to each other by means of a rounded transition.
[0063] The hollow, cylindrical, elongated coupling sleeve 50 may include a bore from the distal side. In this bore are two webs 51 which may be offset by 180° in the circumferential direction and may project radially towards the center and extend over the entire axial length of the bore. The web 51 can be seen in
[0064] In addition, the coupling sleeve 50 may include a distal section and a proximal section, with a sleeve-shaped section disposed between the distal and proximal sections. The proximal section may include an external thread 52 in its proximal end portion, in which the stop nut 40 may engage. In addition, flexible, resilient ratchet arms 53 may be formed in the distal section in the lateral surface, which may serve as a locking element or ratchet element. The ratchet arms 53 may be integrated in the lateral surface of the coupling sleeve 50 and thus may have an arcuate shape.
[0065] As can be seen in
[0066] When the coupling sleeve 50 is now rotated relative to the inner housing sleeve 20 in a discharge direction, the ratchet arms 53 may each slide over the longitudinal grooves 22 with the rounded region 55. That is, in this direction of rotation, the cam 54 may engage the longitudinal grooves 22 only in a force-fit manner and may slide from one longitudinal groove 22 to the next upon rotation due to the rounded area 55 of the cam 54.
[0067] If, on the other hand, the coupling sleeve 50 is rotated in a direction opposite to the direction of discharge relative to the inner housing sleeve 20, the cams 54 may each engage in the longitudinal groove 22. In this direction of rotation, the straight end face 56 of the cam 54 may abut a groove flank of the longitudinal groove 22. Due to the arcuate shape of the ratchet arm 53, further rotation may press the cam 54 deeper or positively into the longitudinal grooves 22, thereby blocking rotation of the coupling sleeve 50 relative to the housing sleeve 20. The ratchet arms 53 may thus allow rotation of the coupling sleeve 50 relative to the inner housing sleeve 20 or housing 10 in the discharge direction, and may prevent rotation in the opposite direction of rotation.
[0068] The sleeve-shaped section of the coupling sleeve 50 may be axially and rotationally fixed to the coupling sleeve 50. Radial click arms 57 may be formed in the sleeve-shaped section of the coupling sleeve 50 in the lateral surface. As can be seen in
[0069] The proximal portion of the coupling sleeve 50 may have a smaller diameter than the distal portion and may serve to rotatably support the dispensing button 60. The dispensing button 60 may be supported on the coupling sleeve 50 by a conical bearing surface at the center of the proximal end of the coupling sleeve 50 (
[0070] As mentioned, the stop nut 40 may be screwed onto the external thread 52 of the coupling sleeve 50. The stop nut 40 may include axially aligned webs 41 on an exterior surface, which may engage in the grooves 32 of the dosing sleeve 30. The stop nut 40 may thus be rotatable relative to the coupling sleeve 50 and axially displaceable but rotationally fixed relative to the dosing sleeve 30.
[0071] The piston rod 70 may include an external thread 71, with which the piston rod 70 may be screwed into the internal thread 21 of the inner housing sleeve 20. As may best be seen in
[0072] At the distal end of the piston rod 70 a button-shaped termination of the piston rod 70 (
[0073] In
[0074] The coupling sleeve 50 may be blocked from rotation in the direction of adjustment by the ratchet arms 53, which engage the longitudinal grooves 22 of the inner housing sleeve 20 with their cams 54. Since the coupling sleeve 50 may be blocked, the piston rod 70, which is rotationally connected to it, may also be blocked.
[0075] If too high a dose is inadvertently set, the dose may be corrected by screwing the dosing sleeve 30 back into the housing 10. The coupling sleeve 50 may continue to be held rotationally relative to the housing 10 due to the force required to move the preloaded ratchet arms 53 of the coupling sleeve 50 out of the longitudinal grooves 22 of the inner housing sleeve 20 being greater than the frictional force between the dosing sleeve 30 and the coupling sleeve 50. Consequently, when a dose is set and corrected, if the dosing sleeve 30 is rotated in the setting direction or in the opposite direction, the coupling sleeve 50 and thus the piston rod 70 cannot rotate.
[0076] As the dosing sleeve 30 rotates relative to the coupling sleeve 50 when a dose is adjusted and corrected, the radial teeth 36 of the dosing sleeve 30 may slide over the teeth 58 of the click arms 57 of the coupling sleeve 50, thereby generating a clicking sound and vibration. Thus, acoustic as well as tactile feedback may be generated for the user in the direction of adjustment (increasing the dose) as well as in the opposite direction (reducing the dose).
[0077] When the dosing sleeve 30 is unscrewed from the inner housing sleeve 20 as well as when the dosing sleeve 30 is screwed into the inner housing sleeve 20, the axial teeth 59 of the coupling sleeve 50 may not engage with the axial teeth 34 of the dosing sleeve 30, whereby the dosing sleeve 30 and the coupling sleeve 50 may be rotated relative to each other.
[0078] The stop nut 40 may be guided axially movably and rotationally fixed in the axial grooves 32 of the dosing sleeve 30. The stop nut 40 may be rotated together with the dosing sleeve 30 when the dosing sleeve 30 is rotated, whereby the stop nut 40 may be screwed on the external thread 52 of the coupling sleeve 50 in the proximal direction. When correcting or turning back the dosing sleeve 30, the stop nut 40 may be correspondingly screwed again in the distal direction.
[0079] To dispense a set dose, the user may press the dispensing button 60 in the distal direction, which may cause the coupling sleeve 50 to shift in the distal direction relative to the dosing sleeve 30. The axial teeth 59 of the coupling sleeve 50 may be brought into engagement with the axial teeth 34 of the dosing sleeve 30 by this displacement, thereby rotationally coupling the coupling sleeve 50 to the dosing sleeve 30.
[0080] The distally acting force may screw the dosing sleeve 30 back into the housing 10. That is, when the biasing force of the ratchet arms 53 is overcome and the cams 54 slide out of the longitudinal grooves 22, the coupling sleeve 50 may be rotated relative to the housing 10. Since the coupling sleeve 50 may now be rotationally coupled to the dosing sleeve 30 and the dosing sleeve 30 may be in threaded engagement with that of the inner housing sleeve 20, the dosing sleeve 30 may begin to screw into the housing 10 with a screwing motion under the distally acting compressive force. The coupling sleeve 50 may also be rotated relative to the housing 10 by the rotating dosing sleeve 30. As a result, the piston rod 70, which may be rotationally connected to the coupling sleeve 50 may also be rotated, which may thereby result in the piston rod screwing distally into the internal thread 21 of the inner housing sleeve 20. Thus, the flange 73 at the distal end of the piston rod 70 may be axially displaced relative to the housing 10 and may distally displace the stopper, which may be located in the cartridge 13. As a result, the medicinal substance may be discharged from the cartridge 13.
[0081] The flexible ratchet arms 53 of the coupling sleeve 50 may be moved over the longitudinal grooves 22 as the coupling sleeve 50 rotates, producing a clicking sound and vibration. Due to the rounded area 55, the ratchet arms 53 may only be moved over the longitudinal grooves 22 in the discharge direction. In the opposite direction, the end faces 56 of the cams 54 abut the flanks of the longitudinal grooves 22 and may thus prevent rotation of the coupling sleeve 50. As a result, the piston rod 70, which may be rotationally connected to the coupling sleeve 50, can only be moved in the dispensing direction.
[0082] As mentioned, there may be no relative movement between the coupling sleeve 50 and the dosing sleeve 30 when the dose is dispensed due to the rotational coupling. As a result, the stop nut 40 may be rotated as well, but the stop not 40 may not be displaced relative to the coupling sleeve 50. That is, the stop nut 40 may not be moved on the external thread 52 in a distal or proximal direction during dose dispensing. Thus, the stop nut 40 may only ever be moved relative to the coupling sleeve 50 and the dosing sleeve 30 during dose adjustment or correction. The thread pitch and dimension of the stop nut 40 may be such that the stop nut 40 abuts the coupling sleeve 50 with a stop at the proximal end of the external thread 52 when the maximum dose, such as the total dose that can be dispensed, has been set. This may ensure that while the user can set and dispense a dose multiple times, a dose cannot be set that exceeds the capacity of the cartridge 13 or any other dose total.
[0083]
[0084] The inner coupling sleeve 180 may be rotationally coupled but displaceable in the direction of the longitudinal axis on the piston rod 170. For this purpose, the inner coupling sleeve 180 may include axial webs which engage in axial grooves in the piston rod 170 as described above. In addition, the inner coupling sleeve 180 may be held axially on the outer or inner housing sleeve 114, 120 by means of a flange (not shown) so that the inner coupling sleeve 180 it is rotatable relative to the housing.
[0085] When setting a dose, the outer coupling sleeve 190 may be displaced proximally out of the housing by the dosing sleeve 130 but not rotated, as described previously in connection with the first implementation. In
[0086] When a set dose is dispensed, the outer coupling sleeve 190 may be rotationally coupled to the dosing sleeve 130, as mentioned in the first implementation. Due to the now rotating outer coupling sleeve 190, the inner coupling sleeve 180 may also rotate and thus may drive the piston rod 170. The threads of the piston rod 170 may rotate through the internal thread 121 in the inner housing sleeve 120, moving the flange of the piston rod 170 distally and allowing the medical substance to be dispensed from the cartridge.
[0087] In another implementation of the dosing and dispensing mechanism according to the present disclosure, the acoustic and/or tactile signal when setting and correcting a dose may be implemented differently than described in the first implementation. For example, instead of the axial teeth 58 of the coupling sleeve and the axial teeth 34 of the dosing sleeve generating an acoustic and/or tactile signal, a click disc with teeth and with a corresponding flange on the dosing sleeve and coupling sleeve may be provided as described in the first implementation of European patent application EP 19163197.7 on pages 15-24 and illustrated in FIGS. 10 and 11. Furthermore, the acoustic and/or tactile signal generated during dose adjustment and correction may be provided by means of an annular click disc as disclosed in European patent application EP 19163197.7 on page 24, line 32—page 25, line 29 in connection with
[0088] Further, instead of the stop nut 40, which may ensure that no dose can be set which exceeds the capacity of the cartridge, an alternative limiting mechanism may be provided. As a result, instead of the stop nut, the external thread 52 of the coupling sleeve, the grooves 32 in the dosing sleeve, the dosing and dispensing mechanism according to the present disclosure may comprise a limiting mechanism between the dosing sleeve 30 and the coupling sleeve 50 with eccentric elements as described in European patent application EP 2 918 298 A1 in paragraphs [0059-0138] and FIGS. 1 to 25b.
[0089] In another implementation, instead of the stop nut, a ball with corresponding guideways may be provided in the coupling sleeve and in the dosing sleeve, as described in PCT patent application WO 2010/149209 A1 on pages 25-27 and shown in FIGS. 3-8. Alternatively, a segment guided in longitudinal guides can be used instead of the ball as disclosed in PCT patent application WO 2010/149209 A1 on pages 27-29 and FIGS. 9-14.
[0090] The disclosures of EP 19163197.7 published as EP 3708206 A1, EP 2 918 298 A1 and WO 2010/149209 A1 are hereby incorporated herein in their entireties for any purpose.
LIST OF REFERENCES
[0091]
TABLE-US-00001 1, 100 Injector 10 Housing 11 Protective cap 12, 120 Cartridge holder 13 Cartridge 14, 114 Outer housing sleeve 16 Opening 17 Ribs 20, 120 Inner housing sleeve 21, 121 Internal thread 22 Longitudinal grooves 23 External thread 24 Distal web or shoulder 25 Proximal web or shoulder 30, 130 Dosing sleeve 31 Internal thread 32 Grooves 33 Handle 34 Axial teeth 35 Bead 36 Radial teeth 40 Stop nut 41 Webs 50 Coupling sleeve 51 Webs 52 External thread 53 Ratchet arms 54 Cam 55 Rounded area 56 End face 57 Click arms 58 Tooth 59 Axial teeth 60 Dispensing button 61 Webs 70, 170 Piston rod 71 External thread 72 Grooves 73 Flange 180 Inner coupling sleeve 190 Outer coupling sleeve