Injection device with an acoustic feedback arrangement
11517680 · 2022-12-06
Assignee
Inventors
- Axel Teucher (Frankfurt am Main, DE)
- Michael Jugl (Frankfurt am Main, DE)
- Stefan Blancke (Frankfurt am Main, DE)
Cpc classification
A61M5/3157
HUMAN NECESSITIES
A61M5/3158
HUMAN NECESSITIES
A61M5/31551
HUMAN NECESSITIES
A61M5/2422
HUMAN NECESSITIES
International classification
A61M5/315
HUMAN NECESSITIES
Abstract
An injection device for setting and injecting of a dose of a medicament includes: an acoustic feedback arrangement comprising: a first feedback element having a first engaging section and having a free end section located at a predetermined distance from the first engaging section, a second feedback element having a second engaging section configured to engage with the first engaging section, wherein the first feedback element is movable, pivotable or resiliently deformable along a first direction (d1) relative to the second feedback element from an initial state (i) towards a biased state (b), and a sound generator formed by the first engaging section or audibly engageable with the free end section of the first feedback element.
Claims
1. An injection device for setting and injecting of a dose of a medicament, the injection device comprising: an acoustic feedback arrangement comprising: a first feedback element having a first engaging section and having a free end section located at a predetermined distance from the first engaging section; a second feedback element having a second engaging section configured to engage with the first engaging section; wherein the first feedback element is movable, pivotable or resiliently deformable along a first direction relative to the second feedback element from an initial state towards a biased state; and a sound generator formed by the first engaging section, wherein the first engaging section is configured to mechanically and audibly engage with the second engaging section when the first feedback element returns from the biased state to the initial state; or a sound generator mechanically and audibly engageable with the free end section of the first feedback element, wherein the free end section comprises a contact surface configured to mechanically and audibly engage with the sound generator when the first feedback element returns from the biased state to the initial state.
2. The injection device according to claim 1, wherein the free end section of the first feedback element is free of contact to any other component of the injection device when the first feedback element is in the initial state.
3. The injection device according to claim 2, wherein the free end section of the first feedback element is transferable to a vibrational state.
4. The injection device according to claim 1, wherein the free end section of the first feedback element is transferable to a vibrational state.
5. The injection device according to claim 4, wherein the first feedback element comprises a body having at least one hollow portion at the free end section.
6. The injection device according to claim 1, wherein the first feedback element comprises a body having at least one hollow portion at the free end section.
7. The injection device according to claim 1, wherein the first feedback element comprises a curved section located between the first engaging section and the free end section.
8. The injection device according to claim 1, wherein the sound generator is transferable to a vibrational state through engagement with the first feedback element when the sound generator is audibly engageable with the free end section of the first feedback element.
9. The injection device according to claim 1, wherein the second feedback element is configured to transfer the first feedback element from the initial state towards the biased state.
10. The injection device according to claim 1, wherein at least one of the first feedback element and the second feedback element comprises a beveled section to engage with the other one of the first feedback element and the second feedback element.
11. The injection device according to claim 1, wherein the first engaging section and the second engaging section are configured to positively engage when the first feedback element reaches the initial state.
12. The injection device according to claim 1, wherein one of the first engaging section and the second engaging section comprises a recess and wherein the other one of the first engaging section and the second engaging section comprises a protrusion, wherein the recess is configured to receive the protrusion when the first feedback element reaches the initial state.
13. The injection device according to claim 1, further comprising a housing accommodating the acoustic feedback arrangement and a dose tracking member movably arranged inside the housing or movably attached to the housing during dispensing of the dose of the medicament, wherein one of the first and the second feedback elements is connected to or integrated into the dose tracking member and wherein the other one of the first and the second feedback elements is connected to or integrated into the housing.
14. The injection device according to claim 13, wherein the dose tracking member comprises one or more of a number sleeve, a clutch member, or a drive sleeve and wherein the dose tracking member is one or both of rotationally or translationally movable relative to the housing during setting of the dose or during dispensing of the dose of the medicament.
15. The injection device of claim 14, further comprising: a cartridge configured to be filled with the medicament, wherein the cartridge is arranged inside the housing and sealed by a bung movably arranged inside a barrel of the cartridge; and a piston rod movably arranged inside and relative to the housing and operably engageable with the bung for expelling of the dose of the medicament from the cartridge.
16. The injection device of claim 15, wherein the cartridge is at least partially filled with the medicament.
17. The injection device according to claim 13, further comprising: a cartridge filled with the medicament, wherein the cartridge is arranged inside the housing and sealed by a bung movably arranged inside a barrel of the cartridge; and a piston rod movably arranged inside and relative to the housing and operably engageable with the bung for expelling of the dose of the medicament from the cartridge.
Description
BRIEF DESCRIPTION OF THE FIGURES
(1) In the following, embodiments of the drive mechanism and the injection device are described in detail by making reference to the drawings, in which:
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
DETAILED DESCRIPTION
(11) The injection device 1 as shown in
(12) When the injection device 1 is configured to administer e.g. human insulin, the dosage set by a dial member 12 at a proximal end of the injection device 1 may be displayed in so-called international units (IU), wherein 1 IU is the biological equivalent of about 45.5 μg of pure crystalline insulin ( 1/22 mg).
(13) As shown further in
(14) The injection device 1 may be configured so that turning the dosage knob 12 causes a mechanical click sound to provide acoustical feedback to a user. The number sleeve 80, a clutch member and a drive sleeve 30 mechanically interacts with a bung 7 in the insulin cartridge 6 via the piston rod 20. When the needle 15 is stuck into a skin portion of a patient, and when the trigger 11 or injection button is pushed, the insulin dose displayed in display window 13 will be ejected from injection device 1. When the needle 15 of the injection device 1 remains for a certain time in the skin portion after the trigger 11 is pushed, a high percentage of the dose is actually injected into the patient's body. Ejection of an insulin dose may also cause a mechanical click sound or a particular end-of dose sound, which is however different from the sounds produced when using the dial member 12.
(15) In some embodiments, during delivery of the insulin dose, the dial member 12 is turned to its initial position in an axial movement, that is to say without rotation, while the number sleeve 80 is rotated to return to its initial position, e.g. to display a dose of zero units.
(16) The injection device 1 may be used for several injection processes until either the cartridge 6 is empty or the expiration date of the medicament in the injection device 1 (e.g. 28 days after the first use) is reached.
(17) Furthermore, before using injection device 1 for the first time, it may be necessary to perform a so-called “prime shot” to remove air from the cartridge 6 and the needle 15, for instance by selecting two units of the medicament and pressing trigger 11 while holding the injection device 1 with the needle 15 upwards. For simplicity of presentation, in the following, it will be assumed that the ejected amounts substantially correspond to the injected doses, so that, for instance the amount of medicament ejected from the injection device 1 is equal to the dose received by the user.
(18) The expelling or drive mechanism 8 as illustrated in more detail in
(19) The piston rod 20 is further provided with a second thread 24 at its proximal end. The distal thread 22 and the proximal thread 24 are oppositely handed.
(20) There is further provided the drive sleeve 30 having a hollow interior to receive the piston rod 20. The drive sleeve 30 comprises an inner thread threadedly engaged with the proximal thread 24 of the piston rod 20. Moreover, the drive sleeve 30 comprises an outer threaded section 31 at its distal end. The threaded section 31 is axially confined between a distal flange portion 32 and another flange portion 33 located at a predefined axial distance from the distal flange portion 32. Between the two flange portions 32, 33 there is provided a last dose limiting member 35 in form of a semi-circular nut having an internal thread mating the threaded section 31 of the drive sleeve 30.
(21) The last dose limiting member 35 further comprises a radial recess or protrusion at its outer circumference to engage with a complementary-shaped recess or protrusion at an inside of the sidewall of the housing 10. In this way the last dose limiting member 35 is splined to the housing 10. A rotation of the drive sleeve 30 in a dose incrementing direction 4 or clockwise direction during consecutive dose setting procedures leads to an accumulative axial displacement of the last dose limiting member 35 relative to the drive sleeve 30. There is further provided an annular spring 40 that is in axial abutment with a proximally facing surface of the flange portion 33. Moreover, there is provided a tubular-shaped clutch member 60. At a first end the clutch member 60 is provided with a series of circumferentially directed saw teeth. Towards a second opposite end of the clutch member 60 there is located a radially inwardly directed flange.
(22) Furthermore, there is provided a dose dial sleeve also denoted as number sleeve 80. The number sleeve 80 is provided outside of the spring 40 and the clutch member 60 and is located radially inward of the housing 10. A helical groove 81 is provided about an outer surface of the number sleeve 80. The housing 10 is provided with the dosage window 13 through which a part of the outer surface of the number sleeve 80 can be seen. The housing 10 is further provided with a helical rib at an inside sidewall portion of an insert piece 62, which helical rib is to be seated in the helical groove 81 of the number sleeve 80. The tubular shaped insert piece 62 is inserted into the proximal end of the housing 10. It is rotationally and axially fixed to the housing 10. There are provided first and second stops on the housing 10 to limit a dose setting procedure during which the number sleeve 80 is rotated in a helical motion relative to the housing 10.
(23) The dose member 12 in form of a dose dial grip is disposed about an outer surface of the proximal end of the number sleeve 80. An outer diameter of the dose member 12 typically corresponds to and matches with the outer diameter of the housing 10. The dose member 12 is secured to the number 80 to prevent relative movement therebetween. The dose member 12 is provided with a central opening.
(24) The trigger 11, also denoted as dose button is substantially T-shaped. It is provided at a proximal end of the injection device 10. A stem 64 of the trigger 11 extends through the opening in the dose member 12, through an inner diameter of extensions of the drive sleeve 30 and into a receiving recess at the proximal end of the piston rod 20. The stem 64 is retained for limited axial movement in the drive sleeve 30 and against rotation with respect thereto. A head of the trigger 11 is generally circular. The trigger side wall or skirt extends from a periphery of the head and is further adapted to be seated in a proximally accessible annular recess of the dose member 12.
(25) To dial a dose a user rotates the dose member 12. With the spring 40 also acting as a clicker and the clutch member 60 engaged, the drive sleeve 30 the spring or clicker 40, the clutch member 60 and the number sleeve 80 rotate with the dose member 12. Audible and tactile feedback of the dose being dialed is provided by the spring 40 and by the clutch member 60. Torque is transmitted through saw teeth between the spring 40 and the clutch member 60. The helical groove 81 on the number sleeve 80 and a helical groove in the drive sleeve 30 have the same lead. This allows the number sleeve 80 to extend from the housing 10 and the drive sleeve 30 to climb the piston rod 20 at the same rate. At a limit of travel a radial stop on the number sleeve 80 engages either with a first stop or a second stop provided on the housing 10 to prevent further movement. Rotation of the piston rod 20 is prevented due to the opposing directions of the overall and driven threads on the piston rod 20.
(26) The last dose limiting member 35 keyed to the housing 10 is advanced along the threaded section 31 by the rotation of the drive sleeve 30. When a final dose configuration or position is reached, a radial stop formed on a surface of the last dose limiting member 35 abuts a radial stop on the flange portion 33 of the drive sleeve 30, preventing both, the last dose limiting member 35 and the drive sleeve 30 from rotating further.
(27) Should a user inadvertently dial beyond the desired dosage, the injection device 1, configured as a pen-injector allows the dosage to be dialed down without dispense of the medicament from the cartridge 6. For this the dose member 12 is simply counter-rotated. This causes the system to act in reverse. A flexible arm of the spring or clicker 40 then acts as a ratchet preventing the spring 40 from rotating. The torque transmitted through the clutch member 60 causes the saw teeth to ride over one another to create the clicks corresponding to dialed dose reduction. Typically, the saw teeth are so disposed that a circumferential extent of each saw tooth corresponds to a unit dose.
(28) When the desired dose has been dialed the user may simply dispense the set dose by depressing the trigger 11. This displaces the clutch member 60 axially with respect to the number sleeve 80 causing dog teeth thereof to disengage. However, the clutch member 60 remains keyed in rotation to the drive sleeve 30. The number sleeve 80 and the dose member 12 are now free to rotate in accordance with the helical groove 81.
(29) The axial movement deforms the flexible arm of the spring 40 to ensure the saw teeth cannot be overhauled during dispense. This prevents the drive sleeve 30 from rotating with respect to the housing 10 though it is still free to move axially with respect thereto. The deformation is subsequently used to urge the spring 40 and the clutch member 60 back along the drive sleeve 30 to restore the connection between the clutch member 60 and the number sleeve 80 when the distally directed dispensing pressure is removed from the trigger 11.
(30) The longitudinal axial movement of the drive sleeve 30 causes the piston rod 20 to rotate through the through opening of the support of the housing 10, thereby to advance the bung 7 in the cartridge 6. Once the dialed dose has been dispensed, the number sleeve 80 is prevented from further rotation by contact of a plurality of members extending from the dose member 12 with a corresponding plurality of stops. A zero dose position is finally determined by the abutment of one of axially extending edges of members of the number indicating sleeve 80 with a corresponding stop of the housing 10.
(31) The dose setting mechanism 9 as illustrated in
(32) During dose setting and when the drive mechanism 8 or the dose setting mechanism 9 is in the dose setting mode the drive sleeve 30 rotates in unison with the dial member 12 and with the number sleeve 80. The drive sleeve 30 is threadedly engaged with the piston rod 20, which during dose setting is stationary with regard to the housing 10. Accordingly, the drive sleeve 30 is subject to a screwing or helical motion during dose setting. The drive sleeve 30 starts to travel in proximal direction as the dose dial member is rotated in a dose incrementing direction 4, e.g. in a clockwise direction. For adjusting of or correcting a size of a dose the dial member 12 is rotatable in an opposite direction, hence in a dose decrementing direction 5, e.g. counterclockwise.
(33) At least one of the drive sleeve 30, the clutch member 60 and the number sleeve 80 serves as a dose tracking member 50 that may comprise a tracking stop feature 51. In some examples, such as the example as illustrated for instance in
(34) The dose setting and expelling mechanism or drive mechanism 8 as described above is only exemplary for one of a plurality of differently configured drive mechanisms that are generally implementable in a disposable pen-injector and with an acoustic feedback arrangement as will be described below. The drive mechanism as described above is explained in more detail e.g. in WO2004/078239A1, WO 2004/078240A1 or WO 2004/078241A1 the entirety of which being incorporated herein by reference.
(35) The injection device 1 further comprises an acoustic feedback arrangement 150, 250 as will be explained in greater detail with regard to
(36) As illustrated by the sequence of
(37) It is also conceivable, that the second direction d2 is oriented tangentially or circumferentially and that the first direction d1 is oriented radially inwardly or radially outwardly.
(38) In some examples, such as the examples of
(39) Prior to reach the zero dose configuration the first engaging section 156 of the first feedback element 152 approaches the second engaging section 158 of the second feedback element 154. While approaching the second engaging section 158 the first feedback element 152 is subject to a resilient deformation. Since the first and second feedback elements 152, 154 are fixed inside the housing or are fixedly attached to the housing 10 with regard to the first direction d1 a movement of the first feedback element 152 towards the zero dose configuration is accompanied by a resilient deformation at least of a portion of the first feedback element 152.
(40) As shown in
(41) During the course of a further movement of the first feedback element 152 along the second direction d2 relative to the second feedback element 154, the degree of resilient deformation increases until the first engaging section 156, e.g. the recess 173 of the first feedback element 152 engages with the second engaging section 158, e.g. the protrusion 174 of the second feedback element 154. During the resilient deformation of the first feedback element 152 along the first direction d1 the first feedback element 152 is mechanically biased or pre-tensed. As indicated in
(42) The first feedback element 152 comprises a resiliently deformable body 151 that is deformable from the initial state i as shown in
(43) As it is further shown in
(44) The free end section 155 of the first feedback element 152 may comprise a curved section 153. The curved section 153 may comprise an arc-shape, wherein in the initial state i of the first feedback element 152 a free end or a contact surface 159 at the free end of the free end section 155 is approximately located at the same level with regards to the first direction d1 than a surface portion 175 of a base portion 177 of the first feedback element 152. Here, the surface portion 175 is located on a side of the first feedback element that faces towards the second feedback element as seen along the first direction d1.
(45) In the biased state b as shown in
(46) At least a portion of the free end section 155, in particular the very end of the free end section 155 may comprise a hollow portion 157. In that part of the free end section of the body 151 of the first feedback element 152 may be of substantially hollow shape. A hollow shape of the curved section 153 of the free end section 155 may further enhance an acoustic amplification of an audible for acoustic signal generated by the mechanical engagement of the first and the second engaging sections 156, 158.
(47) Additionally or alternatively it is also conceivable, that the surface portions 175, 176 of the first and the second feedback elements 152, 154 that face towards each other mutually and audibly engage as the first feedback element 152 returns from the biased state b into the initial state i. As indicated in
(48) In some examples, such as the example of an acoustic feedback arrangement 150 according to
(49) In some examples, such as the example of another acoustic feedback arrangement 250 as shown in
(50) Upon reaching a zero dose configuration as shown in
(51) As the end of dose configuration as shown in
(52) In some examples, such as the example according to
(53) Even though it is illustrated in
(54) Even though with the illustrated example the first feedback element 152 is resiliently deformable it is likewise conceivable, that the first feedback element 152 is pivotally or movably displaced inside the housing 10 along the first direction d1 so as to swivel or to pivot between the initial state i and the biased state b. In that case, the first feedback element may be coupled with a separate restoring element, such as a spring element or the like resiliently deformable element being deformable against a restoring force.
LIST OF REFERENCES
(55) 1 injection device
(56) 2 distal direction
(57) 3 proximal direction
(58) 4 dose incrementing direction
(59) 5 dose decrementing direction
(60) 6 cartridge
(61) 7 bung
(62) 8 drive mechanism
(63) 9 dose setting mechanism
(64) 10 housing
(65) 11 trigger
(66) 12 dial member
(67) 13 dosage window
(68) 14 cartridge holder
(69) 15 injection needle
(70) 16 inner needle cap
(71) 17 outer needle cap
(72) 18 protective cap
(73) 20 piston rod
(74) 21 bearing
(75) 22 first thread
(76) 23 pressure foot
(77) 24 second thread
(78) 25 barrel
(79) 26 seal
(80) 28 threaded socket
(81) 30 drive sleeve
(82) 31 threaded section
(83) 32 flange
(84) 33 flange
(85) 35 last dose limiting member
(86) 40 spring
(87) 50 dose tracking member
(88) 51 tracking stop feature
(89) 60 clutch member
(90) 62 insert piece
(91) 63 stop feature
(92) 64 stem
(93) 80 number sleeve
(94) 81 groove
(95) 150 acoustic feedback arrangement
(96) 151 body
(97) 152 feedback element
(98) 153 curved section
(99) 154 feedback element
(100) 155 free end section
(101) 156 engaging section
(102) 157 hollow portion
(103) 158 engaging section
(104) 159 contact surface
(105) 160 sound generator
(106) 171 beveled section
(107) 172 beveled section
(108) 173 recess
(109) 174 protrusion
(110) 175 surface portion
(111) 176 surface portion
(112) 177 base portion
(113) 250 acoustic feedback arrangement
(114) 260 sound generator