Dual-Function Spring
20230277771 · 2023-09-07
Inventors
- Adrian Eich (Wangenried, CH)
- Aurèle Horisberger (Allschwil, CH)
- Patrick Hostettler (Hasle-Rüegsau, CH)
- Malte Kladiwa (Bern, CH)
- Stefan Meier (Aarberg, CH)
- Peter Stettler (Kirchberg, CH)
- Jürgen Wittmann (Burgdorf, CH)
Cpc classification
A61M5/31543
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
A61M5/31583
HUMAN NECESSITIES
A61M2005/2481
HUMAN NECESSITIES
A61M2005/2086
HUMAN NECESSITIES
A61M2005/202
HUMAN NECESSITIES
A61M5/31541
HUMAN NECESSITIES
A61M5/24
HUMAN NECESSITIES
A61M2005/2477
HUMAN NECESSITIES
A61M5/31558
HUMAN NECESSITIES
International classification
A61M5/24
HUMAN NECESSITIES
Abstract
An injection device for dispensing a product, the injection device including a moveable element which is moved for a dispensing operation, a spring, a product container holder and a product container, wherein the spring pushes against the moveable element to move the moveable element to an initial position after the dispensing operation has ended and against the product container to seat the product container in the product container holder.
Claims
1. (canceled)
2. An injection device for dispensing a product, the injection device comprising a. a housing accommodating a drive unit; b. a product container holder configured for accommodating a product container, wherein a plunger is moveably accommodated in the product container; c. a plunger rod operatively connectable to the drive unit and configured to move in and counter to a dispensing direction, wherein movement by the plunger rod in a dispensing operation causes the product to be dispensed from the product container, wherein the plunger rod includes a freely rotatable but axially fixed flange on a distal end thereof; and d. a moveable element which is moved for a dispensing operation, wherein the movable element is coupled with the plunger rod so that a dispensing movement of the plunger rod is blocked when the injection device is in a non-secured state.
3. The injection device according to claim 2, further comprising a display barrel comprising an external thread configured to locate in an internal thread of the housing such that the display barrel is moved by a rotating movement in an axial direction relative to the housing.
4. The injection device according to claim 3, wherein the display barrel further comprises a first rotational stop acting in a circumferential direction, which moves into an abutting contact with a co-operating complementary stop disposed on the housing upon reaching a maximum dose.
5. The injection device as claimed in claim 4, wherein the complementary stop is defined by a terminal end of an annular gap of the housing.
6. The injection device as claimed in claim 4, wherein the display barrel further comprises a second rotational stop acting in the circumferential direction, which moves into an abutting contact with another co-operating complementary stop disposed on the housing upon reaching a minimum dose.
7. The injection device as claimed in claim 6, wherein the another complementary stop is defined by a proximal end of the internal thread of the housing.
8. The injection device according to claim 2, further comprising a rotationally and axially fixed insert comprising an internal thread which guides an external thread of the plunger rod.
9. The injection device according to claim 2, further comprising: a drive shaft comprising teeth; and an axially displaceable operating element operable by a user, wherein a displacement of the operating element in a distal direction causes the drive shaft to move in the distal direction such that the teeth of the drive shaft locate in a coupling sleeve, thereby coupling the drive shaft and the coupling sleeve and preventing relative rotation therebetween.
10. The injection device as claimed in claim 2, further comprising a device for limiting a maximum dose which can be set beyond an amount of the product remaining in the product container.
11. The injection device as claimed in claim 10, wherein the device for limiting the maximum dose comprises a traveler at least partially surrounding a coupling sleeve.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0040] With regard to fastening, mounting, attaching or connecting components of the present invention, unless specifically described as otherwise, conventional mechanical fasteners and methods may be used. Other appropriate fastening or attachment methods include adhesives, welding and soldering, the latter particularly with regard to the electrical system of the invention, if any. In embodiments with electrical features or components, suitable electrical components and circuitry, wires, wireless components, chips, boards, microprocessors, inputs, outputs, displays, control components, etc. may be used. Generally, unless otherwise indicated, the materials for making embodiments of the invention and/or components thereof may be selected from appropriate materials such as metal, metallic alloys, ceramics, plastics, etc. Unless otherwise indicated specifically or by context, positional terms (e.g., up, down, front, rear, distal, proximal, etc.) are descriptive not limiting. Same reference numbers are used to denote same parts or components.
[0041] The injection device illustrated in
[0042]
[0043] To fit the product container 27 on the drive unit, it may be introduced into the product container holder 16 via the proximal end. The product container holder 16 is then snap-fitted onto the sleeve 50 by an axial movement resulting in a fixed torque-transmitting fit (
[0044] As illustrated in
[0045] As may be seen from
[0046] On its external face, the output element 2 has a thread 2a, which is interrupted by two grooves 2b extending in the axial direction lying opposite one another on the circumference. A coupling sleeve 5 constituting part of a transmission (comprising elements 7, K2, 5) has two projections 5a, 5b directed radially inwardly lying opposite one another on its distal end which project into the grooves 2b of the output element 2. The coupling sleeve 5 is connected to the locating element so that it can rotate but is not able to move axially. Accordingly, the output element 2 is locked to prevent it from rotating relative to the coupling sleeve 5 but is able to move axially relative to the coupling sleeve 5 when it is rotated relative to the locating element. The coupling sleeve 5 is not able to move axially expect for when the product container 27 is being replaced.
[0047] A drive shaft 7 provided at the proximal end of the injection device and forming part of the transmission has teeth 7a extending radially inwardly which constitute a coupling element of the coupling K2. When operated, i.e. when an operating element 15 is pushed in the distal (forward or injection) direction, the drive shaft 7 and as a result also the teeth 7a are moved in the distal direction, as result of which the teeth 7a locate in the proximal end of the coupling sleeve 5 and establish a fixed torque-transmitting, positive connection.
[0048] A spring element or drive spring 3, which may be provided in the form of a helical spring or clock spring, is connected to the housing 12 by one end via a spring sleeve 8 on the external face of the spring 3. The spring sleeve 8 is prevented from rotating relative to the housing 12 but is able to move axially. At the other end, the drive spring 3 is connected to the drive shaft 7. As a result, energy stored in the spring 3 can be output as a rotating movement of the drive shaft 7 relative to the housing 12. To dispense a product, the energy of the spring element 3 is transmitted via the transmission element in the form of a rotating movement to the output element so that the latter is screwed relative to the locating element in the distal direction, i.e. in the dispensing direction, and pushes the plunger 28, causing the product to be dispensed from the product container 27.
[0049] To set a product dose to be administered, a user can rotate the dose setting element 9 provided in the form of a dose setting button, which is axially fixed relative to the housing 12. The dose setting element 9 is coupled with a coupling element 10 via the coupling K3 so that it is prevented from rotating. The coupling K3 is formed by webs or grooves or teeth of the dose setting button 9, which co-operate in a positive fit with webs or grooves or teeth of the coupling disc 10 to establish a coupling which can be released by a movement of the coupling element 10 in the distal direction. The coupling element 10 can be moved and thus released by operating the operating element 15. When in a state of not being operated, the coupling K3 is held in a coupled state and the coupling K2 in an uncoupled state by a spring element 19, which pushes the drive shaft 7 in the proximal (rear or rearward) direction. During the dose setting operation, the coupling K3 is coupled, i.e. a rotating movement of the dose setting button 9 is transmitted to the coupling element 10. The coupling element 10 is connected to the drive shaft 7 so that it can not move axially and can not rotate and could also be an integral part of the drive shaft 7. The rotating movement of the dose setting element 9 is not transmitted to the coupling sleeve 5 because the coupling K2 is uncoupled.
[0050] When the drive shaft 7 is rotated, the drive spring 3 connected to the drive shaft 7 is tensed. To prevent the dose setting button 9 from being turned back due to the drive spring 3 as it is tensed during the setting operation, a ratchet 11 or a ratchet mechanism, which may comprise a ratchet spring 11a, e.g. for clamping retaining elements, may be provided between the housing 12 of the injection device, the components of which might, for example, be a mechanical holder 12a and a mechanical holder 12b and the dose setting button 9. The ratchet mechanism may be designed so that a rotation and/or a tensing of the drive spring 3 is possible in only one direction. In some preferred embodiments, however, the ratchet mechanism is designed so that the rotating action is possible in both directions, e.g. tensing and relaxing of the drive spring 3. Due to the fact of being able to rotate in both directions, a product dose can be both increased and reduced when setting the product dose. A currently set product dose can be read through the window 12d of a display barrel 4.
[0051] The rotating movement of the drive shaft 7 is also transmitted to the threaded sleeve 13, which is connected to the drive shaft 7 so that it is not able to move axially or rotate and may also be an integral part of it. The threaded sleeve 13 has at least one groove on its external circumference 13a in which at least one web 4a of the display barrel 4 locates so that a rotating movement of the threaded sleeve 13 is transmitted to the display barrel 4 by the anti-rotation coupling, permitting an axial relative movement between the display barrel 4 and threaded sleeve 13. The display barrel 4 has a thread 4b on its external face which locates in an internal thread 12c of the housing part 12b so that the display barrel 4 is moved due to a rotating movement in the axial direction relative to the housing 12, e.g. in the distal direction. In some preferred embodiments, the display barrel 4 moves in the distal direction of the injection device (towards the left in
[0052] Once the dose has been set and the drive spring 3 primed by rotating the dose setting button 9, the setting operation is complete. In some preferred embodiments, the dose is primed as the spring 3 is tensed. To correct or adjust the dose, the dose setting button 9 simply has to be rotated in the opposite direction, e.g. to reduce a dose which might have been set too high. In some embodiments, the ratchet 11 may be designed as illustrated in
[0053] During the dispensing process, which is triggered by depressing the push button 15, the display barrel 4 is rotated back in the opposite direction and is moved back in the proximal direction due to the thread engagement with the internal thread 12c of the injection device (to the right in
[0054] The coupling K1, comprising the coupling element acting as a lock sleeve 14 and the coupling sleeve 5, is used to couple the coupling sleeve 5 with the housing 12 so that it can not rotate in specific operating modes or to release it to permit a rotation relative to the housing 12. The coupling K1 is uncoupled when the product container 27 is being replaced to enable the output element 2 to be pushed back or screwed in the proximal direction again and to enable the output element 2 to be screwed in the distal direction while product is being dispensed. The coupling K1 is coupled when the product container is attached to the drive unit and the operating element 15 is not being operated. The coupling K1 is provided in the form of teeth on the external face of the coupling sleeve 5, which mesh in teeth on the internal face of the lock sleeve 14. As a result, the coupling sleeve 5 is prevented from rotating relative to the lock sleeve 14. The lock sleeve 14 is mounted in the injection device so that it can not rotate but can move axially relative to the housing 12 and the coupling sleeve 5.
[0055] During a dispensing operation, the threaded sleeve 13 is moved in the distal (forward or injection or delivery) direction by operating the operating element 15. As this happens, the threaded sleeve 13 pushes on the bearing 29, which is provided in the form of a ball bearing in this example but may also be a simple slide bearing, so that the bearing 29 pushes against the lock sleeve 14, thereby moving it in the distal direction for a dispensing operation, and holds it in a distal position during a dispensing operation. The coupling element 14 is therefore disposed distally of the projections of the coupling sleeve 5 for the coupling K1. As a result, the coupling K1 remains uncoupled for the duration of the dispensing operation.
[0056] When the operating element 15 is operated, the couplings K1, K2 and K3 operate as follows. By depressing the push button 15 seated on the coupling element 10 and/or drive shaft 7, the coupling element 10 is pushed in the distal direction together with the push button 15 and the drive shaft 7. As a result, the coupling K2 is coupled so that the drive shaft 7 is prevented from rotating relative to the coupling sleeve 5. The coupling K1 is then uncoupled due to the movement of the lock sleeve 14, against which the threaded sleeve 13 connected to the drive shaft 7 pushes via the axially displaceable bearing 29. Alternatively, the couplings K1 and K2 may be connected in the reverse sequence.
[0057] Once K2 is coupled and K1 is uncoupled, the coupling K3 is also uncoupled due to the movement of the coupling element 10 relative to the dose setting button 9. The coupling element 10, which is connected to the drive shaft 7, is able to rotate relative to the housing 12 once the coupling K3 is uncoupled. The energy or force stored in the drive spring 3 during priming can be transmitted to the drive shaft 7. Accordingly, a torque is applied to the drive shaft 7, which is transmitted by the coupled coupling K2 to the coupling sleeve 5, which rotates in unison with the drive shaft 7 and transmits this rotating movement to the output element 2, which is coupled with the coupling sleeve 5 so that it can not rotate. The output element 2, provided in the form of a threaded rod in this example, converts the rotating movement into an axial movement in the distal direction due to the thread engagement 2a, 6a with the locating element (comprising elements 6, 26), so that the flange 1 provided on the distal end of the threaded rod 2, which may also be construed as part of the output element, is moved in the distal direction of the injection device.
[0058] Since, during the product dispensing operation, the threaded sleeve 13 moves in the direction opposite that in which it moves during priming, the display barrel 4 likewise moves in the direction opposite that of the priming operation.
[0059] In the normal situation, i.e. when a pre-set product dose has been fully dispensed, the dispensing operation and the movement of the output element 2 in the distal direction continues until the display barrel 4 makes contact with the above-mentioned stop acting in the circumferential direction. In some embodiments, this happens when the value which can be read through the window 12d has been rotated back to 0.
[0060] In the situation in which the user of the device releases the operating element 15 as the product is being dispensed, the couplings couple in the order which is the reverse of that in which they uncoupled or coupled during operation. The product dispensing operation is interrupted, as a result of which the value may be seen through the window 12d represents the amount still to be dispensed had the pre-set dose been fully dispensed. The product dispensing operation can be continued by depressing the operating element 15 again, and dispensing can be stopped again by releasing the operating element 15 or the user can wait until the product has been fully dispensed.
[0061] In the situation in which the product container contains less product than the maximum dose indicated on the display barrel, the injection device based on this example has an additional device for limiting the maximum dose which can be set for the last time, to prevent the possibility of a bigger product dose being set than that which is still in the container. To this end, a traveller 30 is provided, which at least partially surrounds the coupling sleeve 5 and locates with the coupling sleeve 5 in such a way that the traveller 30 is not able to rotate relative to the coupling sleeve 5 but is able to move axially. The traveller 30 also locates or is positioned by a thread on its external circumference that engages with an internal thread of the threaded sleeve 13. This arrangement causes an axial movement of the traveller 30 when there is a relative rotation between the threaded sleeve 13 and coupling sleeve 5, and when there is no relative rotation the traveller 30 does not effect an axial movement. When setting a product dose, the threaded sleeve 13 turns relative to the coupling sleeve 5 so that the traveller 30 moves in the proximal direction. During dispensing, on the other hand, no relative movement takes place between the coupling sleeve 5 and threaded sleeve 13 due to the coupled engagement of the coupling K2. Accordingly, the traveller does not move. After setting doses and dispensing product several times, the traveller 30 moves into an abutting contact with the drive shaft 7, so that it is no longer possible to increase the dose, even if the display would actually permit this.
[0062] The user can replace the product container 27 with a new one. To this end, the product container holder 16 may be removed by rotating the drive unit relative to the housing 12. As the product container 27 is moved from the secured position into the non-secured position, e.g. as the bayonet fitting is released, the locating element is moved together with the output element 2 and the coupling sleeve 5 in the distal direction relative to the housing 12 and to the coupling element 14, thereby releasing the coupling K1. The projections of the coupling sleeve 5 pointing radially outwardly to establish the coupling K1 are now disposed distally of the coupling element 14. The output element 2 can now be screwed into the drive unit with a relatively slight force acting in the proximal direction because the thread of the output element is not retained by friction. As the output element 2 is screwed back, the coupling sleeve 5 is turned relative to the threaded sleeve 13 and so in the direction opposite that during product dispensing, causing the traveller 30 to be pushed back in the distal direction again. The screwing-back operation may take place against the force of a spring element, at least across a part of the total distance, which tries to push the output element in the distal direction, for example. The spring element may act or be disposed between the output element 2 and the drive shaft 7 for example. Other possible spring elements will be described below specifically with reference to
[0063] Also during the process of removing the product container 27, the retaining element 25 used to secure the product container 27 in the product container holder 16 is pushed in the distal direction by the spring 19 until it makes contact with the locating element 6, 26. This contact prevents the spring 19 from fully relaxing when the product container 27 is removed. This is of advantage because the spring 19 should be able to apply sufficient force to hold the coupling K3 in a coupled engagement even when a product container 27 has been removed.
[0064] By virtue of another aspect, a spring-mounted flange may be used, as illustrated in
[0065] After replacing the product container 27, e.g. an ampoule, capped vial or the like, the user is prompted to proceed with priming, as may be described in operating instructions. This is useful on the one hand because there may be air in the product container 27 and on the other hand because the output element 2 may have been previously pushed fully into the drive unit and a certain amount of clearance may have been created between the plunger 28 and the flange 1 due to the different level to which the product container 27 is filled.
[0066]
[0067] After pushing in the flange 1 connected to the threaded rod 2, the flange 1 based on the embodiment illustrated in
[0068] In the embodiment illustrated in
[0069] As may be seen from
[0070]
[0071] Due to the fixed torque-transmitting connection between the transmission element (which, again, may be thought of and/or referred to as comprising elements 7, K2, 5) during a dispensing operation or when what may be thought of and/or referred to as “firing blank,” i.e. when no product container has been inserted, the brake shoe 17 is moved in rotation relative to the brake disc 18. When this happens, the disposition of the brake shoe teeth 17a, 17b ensure that the brake disc 18 oscillates axially between the threaded sleeve 13 and the brake shoe 17. As a result, the distal teeth 18a and proximal teeth 18b of the brake disc 18 move alternately into contact with the co-operating complementary teeth 17b and 17a. Due to one or more of the resultant friction, elastic deformation and the oscillating mass, a corresponding loss occurs, thereby limiting the maximum angular speed w of the rotating parts 13 and 17.
[0072] The embodiment illustrated in
[0073] Due to the vibration or oscillation of the brake disc 18 between the threaded sleeve 13 and brake shoe 18 which increases with the angular velocity ω, the braking force increases disproportionately as the angular velocity ω increases, so that the curve BS of braking forces schematically illustrated in
[0074]
[0075]
[0076] Due to the braking force generated by the oscillating brake disc 18, the maximum possible angular velocity ω.sub.max of a dispensing movement can be reduced or limited so that the backward-rotating display barrel 4 is able to move into an abutting contact with the stop acting in the circumferential direction or the housing part 12b at only a maximum speed predefined by the brake. If the brake is designed accordingly, the maximum possible contact speed of the display barrel 4 is so low that there is little chance of deformation or damage occurring due to the impact. Other brake mechanisms may also be used as an alternative to a brake disc 18 oscillating between the threaded sleeve 13 and brake shoe 17.
[0077] For example, as an alternative or in addition, the brake may be based on another embodiment in the form of a centrifugal brake as illustrated in
[0078] In another embodiment illustrated in
[0079] In some preferred embodiments, the brake disc 21 is made from a good electrical conductor, such as pure aluminium or copper, for example. Rare earth alloys may be used as the material for the axially magnetised magnets 22, neodymium for example. The permanent magnetic field may be linked by a magnet yoke 23 made from iron to the air gap, where it extends through the brake disc 21 as vertically as possible. The braking force is created by the surface and flow density in the air gap and the rated current in the brake disc 21, for which purpose the surface should be as large as possible, the air gap should be as small as possible and the disc thickness should be as big as possible. The braking torque occurs over the averaged radius (working radius). Brakes may be designed with several magnet systems which act on a disc 21.
[0080] The usual approximation calculations are used to calculate the current density, braking power and hence braking torque of an eddy current brake. Leaving aside the effect of the air gap, it is assumed that there will be a standard cylindrical magnetic flow and it is stipulated as a condition that the pole diameter should be sufficiently small compared with the radius of the disc 21. At high speeds, the approximation is inaccurate, among other reasons because the magnetic fields caused by the eddy currents cause a not inconsiderable feedback and hence non-linearity.
[0081] In some preferred embodiments, the magnets 22 and the magnet yoke 23 are connected to the housing 12 of the injection device or the housing part 12b or another non-rotating part to be able to generate the desired eddy current braking effect of the brake disc 21.
[0082] In another embodiment illustrated in
[0083] In the case of the fluidic brake, the braking force is generated by two fluid surfaces moving against one another. In particular, the braking force is generated by a fluid volume which is sheared by a relative movement. The shearing stresses which occur during such movements correspond to the braking force. The volume is provided in the form of a chamber split into two parts 45a, 46a, in which the fluid is disposed. One chamber part 46a is disposed in a rotating part 46 and the other chamber 45a is disposed in a part 45 relative to which the rotating part 46 is able to rotate. The part 46 may be connected so as to rotate in unison with the drive shaft 7 or to the transmission element or another part which rotates when product is being dispensed. The part 45 rotates in unison with at least the housing 12 or a stationary part on the housing. Furthermore, the part 45 may be able to move axially or may be axially immobile relative to the housing 12. The sleeve-shaped part 45 may be thought of and/or referred to as a brake housing and the part 46 mounted in the sleeve 45 as a brake shaft. When the brake is in the assembled state, the fluid chamber halves 46a distributed axially around the external circumference of the brake shaft are axially on a level with the fluid chamber halves 45a distributed around the internal circumference of the brake housing. More, the same number or fewer fluid chamber halves 45a may be provided than 46a. In the assembled state, a slim gap is disposed between the internal diameter of the brake housing 45 and the external diameter of the brake shaft 46 in the region of each of the fluid chamber halves 45a, 46a, which may be dimensioned so that fluid is conveyed into the gap or no fluid or virtually no fluid is conveyed into the gap when the brake shaft 46 is rotating relative to the brake housing 45. The brake housing 45 may be axially sealed at both ends with sliding seal elements 47 so that no fluid is able to escape from the brake. The seal elements 47 may be provided in the form of a lid. The lid may be provided as a separate part or serve as the coupling shaft, for example.
[0084] Embodiments of the present invention, including preferred embodiments, have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms and steps disclosed. The embodiments were chosen and described to illustrate the principles of the invention and the practical application thereof, and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled.