MODULAR SYRINGE HOLDER AND SYRINGE ASSEMBLY METHOD
20210353862 · 2021-11-18
Inventors
Cpc classification
A61M5/2033
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
A61M2005/3247
HUMAN NECESSITIES
A61M2005/2013
HUMAN NECESSITIES
A61M5/3202
HUMAN NECESSITIES
A61M5/24
HUMAN NECESSITIES
A61M2005/2477
HUMAN NECESSITIES
International classification
A61M5/24
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
Abstract
Modular syringe holders receive small-volume product containers for use in injection devices configured for nominally large-volume product containers, and include an adapter and an adapter holder configured for insertion in such injection devices. The adapter includes a hollow-cylindrical, rigid adapter body and a radially deflectable support element for a receiving a syringe shoulder of a pre-filled syringe. During receipt of the pre-filled syringe, the support element undergoes a radial deflection by a needle protection cap of the pre-filled syringe. The adapter holder is configured to receive the adapter, and a holding portion of the adapter holder blocks the support element against radial deflection in a holding position in an engagement with the syringe shoulder. With the adapter and pre-filled syringe received in the adapter holder, a flexible shoulder-support element diverts axial forces of the shoulder of the pre-filled syringe and is secured by the adapter holder against lateral deflection.
Claims
1. A modular syringe holder, comprising: an adapter holder configured to be received in a housing of an injection device; and an adapter comprising an adapter body and a support element flexibly coupled to the adapter body, wherein the support element of the adapter is configured to receive, along a longitudinal axis of the syringe holder, a syringe shoulder of a pre-filled syringe, and wherein the adapter holder is configured to receive the adapter such that the support element is blocked by a holding portion of the adapter holder from deflecting in a radial direction.
2. The modular syringe holder according to claim 1, wherein the support element is flexibly coupled to the adapter body such that the support element is configured to be deflected in the radial direction by a needle protection cap of the pre-filled syringe prior to the adapter being received in the adapter holder.
3. The modular syringe holder according to claim 1, wherein the adapter further comprises a flexible finger, and wherein the support element is coupled to a distal end of the finger and protrudes from the finger in a direction transverse to the longitudinal axis.
4. The modular syringe holder according to claim 1, wherein the adapter and the adapter holder are configured such that the support element directly contacts the housing of the injection device in an axial direction.
5. The modular syringe holder according to claim 1, wherein the adapter holder is secured by a plurality of securing elements in an axially and rotationally fixed manner in the housing of the injection device, and wherein the adapter and the adapter holder are configured to enable a rotation of the pre-filled syringe about the longitudinal axis.
6. The modular syringe holder according to claim 5, wherein the adapter and the adapter holder are configured such that the support element directly contacts the housing of the injection device in an axial direction.
7. The modular syringe holder according to claim 6, wherein the support element is flexibly coupled to the adapter body such that the support element is configured to be deflected in the radial direction by a needle protection cap of the pre-filled syringe prior to the adapter being received in the adapter holder.
8. The modular syringe holder according to claim 1, wherein the adapter further comprises two support elements and two flexible fingers, and wherein each of the flexible fingers comprises one of the support elements and such support element is configured for receiving axial forces of the syringe shoulder.
9. A method for assembling a pre-filled syringe in an injection device, the injection device comprising a housing defining a longitudinal axis, the method comprising: inserting a syringe holder into the housing of the injection device in a first axial position relative to the housing, wherein in the first axial position a support element of the syringe holder is flexibly coupled to a holder sleeve of the syringe holder such that the support element is radially deflectable; blocking the syringe holder against a movement in a distal direction; introducing a pre-filled syringe into the syringe holder in the distal direction, wherein the pre-filled syringe causes the support element to undergo a radial deflection by a needle protection cap of the pre-filled syringe; releasing the blocked movement of the syringe holder in the distal direction; and moving the syringe holder into a second axial position such that the support element is blocked by a holding portion of the housing against the radial deflection.
10. The method of claim 9, wherein the syringe holder is blocked against a movement in the distal direction by an assembly tool engaging on an assembly supporting element of the syringe holder.
11. The method of claim 10, further comprising introducing the assembly tool perpendicular to the longitudinal axis through an inspection window of the housing.
12. The method of claim 9, wherein the pre-filled syringe comprises a product receiving portion and an injection needle nondetachably fastened thereon, wherein the product receiving portion comprises a nominal filling volume of less than 2.25 mL, and wherein the pre-filled syringe is axially nonshiftably held in the housing of the injection device.
13. An injection device comprising a modular syringe holder with a pre-filled syringe inserted therein, wherein the injection device is configured as an autoinjector, the modular syringe holder comprising: an adapter holder received in the housing of an injection device; and an adapter comprising an adapter body and a support element flexibly coupled to the adapter body, wherein the support element is flexibly coupled to the adapter body such that the support element is configured to be deflected in the radial direction by a needle protection cap of the pre-filled syringe prior to the adapter being received in the adapter holder, wherein the support element of the adapter is configured to receive, along a longitudinal axis of the syringe holder, a syringe shoulder of the pre-filled syringe, wherein the adapter holder is configured to receive the adapter with the pre-filled syringe inserted therein such that a holding portion of the adapter holder blocks the support element from deflecting in a radial direction, wherein the pre-filled syringe comprises a product receiving portion and an injection needle nondetachably fastened thereto, wherein the product receiving portion comprises a nominal filling volume of less than 2.25 mL, and wherein the pre-filled syringe is axially nonshiftably held in the housing of the injection device by the modular syringe holder.
14. The injection device according to claim 13, wherein the adapter and the adapter holder are configured such that the support element directly contacts the housing of the injection device in an axial direction.
15. The injection device of claim 13, wherein the adapter and the adapter holder are configured to enable a rotation of the pre-filled syringe about the longitudinal axis.
16. The injection device of claim 13, wherein the injection device comprises a drive with a spiral spring, wherein in a delivery state, the spiral spring stores at least an amount of energy for a complete discharge of a product in the product receiving portion.
17. The injection device of claim 13, wherein the injection device comprises a drive, the drive comprising a spring pack with a spring shaft, a spiral spring, and a spring sleeve, wherein the spiral spring is rotationally fixed with respect to the longitudinal axis and connected by an inner end to the spring shaft and connected by an outer end to the spring sleeve, wherein a first securing element is arranged on the spring sleeve and a second securing element is arranged on the spring shaft, wherein when the first securing element is in an engagement with the second securing element, the spring sleeve is secured in a rotationally fixed manner relative to the spring shaft with respect to the longitudinal axis, wherein the engagement can be released by a release movement of the first securing element; wherein during the assembly of the spring pack onto a drive unit of the injection device, a control element of the spring pack can be moved by a release element of the drive unit such that the first securing element performs the release movement and a torque stored in the spring pack is coupled to the drive unit.
18. The injection device of claim 17, wherein the outer end of the spiral spring comprises an opening which, with tensioning of the spiral spring, can be hooked in a prong of the spring sleeve.
19. The injection device of claim 17, wherein the drive is configured to receive one of a plurality of different spring packs, wherein a first spring pack of the plurality of different spring packs is configured with a first torque stored in the first spring pack, and wherein a second spring pack of the plurality of different spring packs is configured with a second torque stored in the second spring pack that differs from the first torque.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] In connection with the appended figures, implementations of the present disclosure are described herein. They are intended to show basic possibilities of the disclosed implementations and should in no way be interpreted to be limiting.
[0031]
[0032]
[0033]
[0034]
[0035]
[0036]
[0037]
[0038]
[0039]
[0040]
[0041]
[0042]
[0043]
DETAILED DESCRIPTION
[0044]
[0045] In the syringe holder 11, a pre-filled syringe 2 may be received and held therein. The pre-filled syringe 2 may include a cylindrical syringe body 21 that may be configured as a product container, which may define a product receiving space 24 between a syringe shoulder 22 and a piston or stopper 23, where the stopper may be shifted along the longitudinal axis L (
[0046] The injection needle 25 of the pre-filled syringe 2 may be covered by a needle protection cap 27, which may be configured as a so-called Rigid Needle Shield (RNS) and may include a flexible or rubber-elastic needle guard element and a sleeve made of hard plastic. The needle protection cap 27 may protect the injection needle 25 from unintentional detachment or other mechanical actions and from soiling and thus may maintain the sterility of the injection needle and the product contained in the pre-filled syringe 2. Between the syringe shoulder 22 and the proximal end of the sleeve of the needle protection cap 27, at least a portion of which may be made of hard plastic, a gap may be formed. On the distal end of the autoinjector, in the delivery state thereof, a pull cap 30 may be arranged, which, before the use of the autoinjector, may be axially pulled and/or twisted off and completely removed. The pull cap 30 may include snap hooks or a separate protection cap remover 31 that may at least be axially held in the pull cap 30, and the snap hooks or protection cap remover 31 may be arranged in the gap and removal of the pull cap 30 may result in release of the needle protection cap 27 from the pre-filled syringe 2.
[0047] The injection needle 25 may be surrounded by a needle protection sleeve 40 mounted in an axially shiftable manner relative to the housing 10 and insertable or slidable into the housing 10. In the starting position of the needle protection sleeve 40, the distal end of the needle protection sleeve 40 may protrude distally over the needle tip of the injection needle 25, so that access to the needle tip may be initially prevented. The needle protection sleeve 40, at a distal or front side, may include an opening through which the injection needle 25 may protrude, and during a relative movement of the needle protection sleeve 40 and the injection needle 25, the injection needle 25 may enter through the opening and into an injection site. The needle protection sleeve 40 may also be used as a trigger element for triggering the product discharge, where, for this purpose, the needle protection sleeve 40, which may be biased by a needle protection sleeve spring 41, may be shifted relative to the housing 10 in the proximal direction. For instance, the needle protection sleeve 40 may include two sleeve arms 40a, which may be arranged offset or rotated by 90° about the longitudinal axis L with respect to two inspections windows 10a or two recesses of the housing 10, which may be referred to as inspection windows. After an injection has occurred, the needle protection sleeve 40 may be shifted relative to the housing 10 from the actuated position along the longitudinal axis L in the distal direction into a needle protection position and may be blocked from being pushed back in the proximal direction.
[0048] The autoinjector may include a switching module with a switching sleeve 42 and a blocking sleeve 43 surrounded by the switching sleeve 42. The switching sleeve 42 may be connected to a proximal end of the sleeve arms 40a of the needle protection sleeve 40 and to a distal end of the needle protection sleeve spring 41. The needle protection sleeve spring 41 may be formed as a spring made of metal and may serve as a compression spring and may be configured as a coil spring.
[0049] The autoinjector may include a drive with an axially shiftable plunger rod 50 that may be configured as an advancing element for moving the piston 23 in the discharge direction. The autoinjector may include a holding element 51 with two flexible holding arms 51a, where, on a distal end of each holding arm 51a, a first engagement element 51b and a second engagement element 51c may be arranged. The first engagement element 51b may extend radially toward the longitudinal axis L, and the second engagement element 51c may extend radially away from the longitudinal axis L. In the delivery state of the device, the first engagement element 51b may be held in an engagement with a recess 50a of the plunger rod 50 by the inner periphery of the blocking sleeve 43, which may be in contact with the second engagement element 51c, where a movement of the plunger rod 50 relative to the holding element 51 in the discharge direction may be prevented. The needle protection sleeve spring 41 may be supported by its proximal end on the holding element 51, for instance on a projection 51d of the holding element 51, which may engage in an axially shiftable and rotationally fixed manner in the housing 10.
[0050] The drive may additionally include a spring pack 6 (
[0051] The pre-filled syringe 2 may be received in the syringe holder 11 and may be secured at least against a movement along the longitudinal axis L in the distal direction relative to the syringe holder 11. For instance, the syringe holder 11 may include at least one inwardly protruding and proximally directed axial support element 11a on which the spring shoulder 22 may be supported against movement in the distal direction. In order to prevent a proximal movement of the pre-filled syringe 2, the pre-filled syringe 2 may be pressed by a holding spring portion 13a of a mechanism holder 13, which may engage on the finger flange 26 of the pre-filled syringe 2, into an engagement with the support element 11a. In some implementations, the holding spring portion 13a may account for longitudinal differences of the syringe body 21, which may be generated due to manufacturing tolerances. Between the finger flange 26 and the proximal end of the syringe holder 11, a gap may be formed. The housing 10 may include an annular peripheral holding portion 10b (
[0052] The pre-filled syringe 2 represented in
[0053]
[0054]
[0055] As second step, the pre-filled syringe 2 may be axially inserted into the one-piece syringe holder 11 (
[0056] Instead of the two assembly supporting elements 11g, which may be arranged opposite one another on the one-piece syringe holder 11, a single assembly supporting element or more than two assembly supporting elements may also be provided. The process of supporting the one-piece syringe holder 11 may involve configuring one or more assembly supporting elements that are adapted to suitable recesses in the housing 10 and/or to capabilities of the assembly tool, with the goal of enabling a simple or streamlined intermediate assembly step, e.g., involving the first and second assembly steps. In implementations when the assembly tool can be positioned before the introduction of the one-piece syringe holder 11, the syringe holder 11 may be configured without the second snap elements 11e when otherwise used in connection with positioning the one-piece syringe holder 11 in the first axial position (e.g.,
[0057]
[0058] The adapter body 14c of the adapter 14 may include two adapter arms which may be connected on their distal end via webs and on their proximal end via an extension. The arms may define and delimit, in the direction of the longitudinal axis L, two longitudinal recesses in the adapter body 14c, which, in the assembled state, each of the recesses may be aligned with one of the inspection windows 10a of the housing 10 and may thereby avoid obstructing a view into the syringe body 21 of the pre-filled syringe 2. The proximal extension may form an adapter shoulder and an inner space with a diameter, which may be enlarged with respect to the adapter body, for receiving the finger flange 26 of the pre-filled syringe 2. The adapter 14 moreover may include two elastic fingers 14b, which may be attached on their proximal ends to the adapter body 14c and which may each include, on their distal ends, an axial support element 14a for supporting the syringe shoulder 22 of the pre-filled syringe 2.
[0059] The holder sleeve 15a of the adapter holder 15 may include an annular peripheral holding portion 15b on its inner side, which may surround the distal end of the assembled adapter 14 in a circumferential manner, and which may secure the support elements 14a against radial deflections. The distal end of the holder sleeve 15a may not include holding elements or narrowings. In this manner, the adapter 14 may rest with its distal ends of the support elements 14a directly against the housing 10 of the autoinjector, and axial forces may be diverted onto the product container of the pre-filled syringe 2 from the syringe shoulder 22 via the support elements 14a to the housing 10. In this position, the finger flange 26 of the pre-filled syringe 2 may not be in contact with the adapter shoulder of the adapter body 14c and the pre-filled syringe 2 may not be prevented from rotating by the adapter extension or by the adapter holder 15 or another housing portion, so that the assembled pre-filled syringe 2 may freely rotate. On the holder sleeve 15a, two first snap elements 15c or securing elements may be provided and may be arranged opposite one another and the snap elements 15c may be used for engagement in the housing 10; and two second and third snap elements 15d, 15e or securing elements, each of which may be arranged opposite one another may be used for engagement in recesses of the needle protection sleeve 40.
[0060] For assembly of the pre-filled syringe 2, the adapter holder 15 may be first introduced into the housing 10 of the autoinjector and snapped with two mutually opposite first snap elements 15c into recesses of the housing 10, which may be complementary thereto, in an axially nondetachable and rotationally fixed manner. Subsequently, outside of the injection device, the pre-filled syringe 2 may be introduced axially in the distal direction into the adapter 14. In the process, the needle protection cap 27 may be pressed through an opening formed by the fingers 14b, where the fingers 14b may be deflected radially outward through the sleeve of the needle protection cap. As soon as the proximal end of the needle protection cap has cleared the opening, the fingers may snap radially inward, e.g., into the gap formed between the needle protection cap 27 and the syringe shoulder 22 of the syringe body 21, and position the support elements 14a in a holding position in engagement with the syringe shoulder 22. Finally, the adapter and the syringe may be introduced in a rotatably correct position into the adapter holder. In order to prevent a proximal movement of the pre-filled syringe 2, the pre-filled syringe may be pressed by a holding spring portion 13a of the mechanism holder 13, which may engage on the finger flange 26, into engagement with the support element 14a.
[0061] In the two implementations described herein, each support element 11a, 14a may include a portion or a section of a circular ring with an average diameter corresponding to a diameter of the syringe shoulder 22. The support element 11a, 14a may be coupled to a distal end of their respective finger 11b or 14b and may protrude from the finger in a direction transverse to the longitudinal axis. For example, the support element 11a, 14a and/or a central arc length of the section thereof may be greater than a width of the finger (11b, 14b) The support element 11a, 14a may protrude in both directions of rotation from the finger (11b, 14b), and the finger and the support element may together define the shape of an anchor. During the assembly of a pre-filled syringe 2, the needle protection cap 27 of the pre-filled syringe 2 may be pressed through the opening formed by the fingers 11b, 14b, where the fingers 11b, 14b may be deflected radially outward by the sleeve portion of the needle protection cap 27. As soon as the proximal end of the needle protection cap 27 has cleared the opening, the fingers 11b, 14b may snap radially inward and position the support elements 11a, 14a in a holding position in engagement with the syringe shoulder 22. Thereby, the opening formed by the inner edges of the support elements 11a, 14a may be in an engagement with the pre-filled syringe 2 and may have a diameter which is smaller than an outer diameter of the needle protection cap 27. The support surfaces of the support elements 11a, 14a may thus be arranged at least partially in the gap between the needle protection cap 27 and the syringe shoulder 22, and may also make it possible for axial forces of the pre-filled syringe 2 to be received by the support elements 11a, 14a when an outer diameter of the pre-filled syringe 2 is not significantly greater than, or not greater than, the outer diameter of the needle protection cap. By means of the holding portion 10b, 15b of the respective housing 10 or of the adapter holder 15, which may ensure engagement and which may rest with little play against an outer periphery of the fingers 11b, 14b, the fingers may be prevented from moving transversely to the longitudinal axis, and, in the process, may prevent compromising the axial support provided by the support elements 11a, 14a against the syringe shoulder 22.
[0062] As an alternative to providing two support elements 11a, 14a on two fingers 11b, 14b, one support element may instead be provided in the form of a radially inward directed collar or a narrowing, which may be temporarily widened by the needle protection cap. The collar may be discontinuous and may include a radial slot to form a C-shaped circular arc section spanning over 180°, which may be elastically spread apart, e.g., perpendicular to the longitudinal axis L, by the needle protection cap 27 and may be pushed away. In addition or alternatively, more than two fingers and/or, instead of anchor-shaped support elements, only support elements having the width of the respective finger may be provided. The spatial volume in which the finger(s) 11b of the first embodiment may be deflected when the pre-filled syringe 2 is introduced, and/or the holding portion 10b, 15b of the respective housing 10 and of the adapter holder 15 may be adjusted in accordance with the number of fingers and the extension of the support elements and/or in terms of shape. Instead of the elastic fingers, flexible non-elastic fingers may instead be provided, for example, with a joint, such as a film joint or flexible hinge joint, in the transition to the holder sleeve 15a or to the adapter body 14c. In this case, the support element 11a, 14a may be guided first by appropriate inclinations on the proximal end of the holding portion 10b of the housing 10 and of the adapter holder 15 during the final movement of the pre-filled syringe 2 into engagement with the syringe shoulder 22.
[0063] By the use of a syringe holder 11 according to the first implementation, or of a modular syringe holder 14, 15 according to the second implementation, an injection device configured for nominally large-volume product containers may also be used with small-volume product containers. The transition to a product container with a smaller diameter and a shorter length according to the present disclosure may additionally require at least, or at most, an exchange of a plunger rod and of a mechanism holder. A plunger rod with a smaller diameter may fit into the smaller product container of the present disclosure, and a longer mechanism holder and/or a longer holding spring portion may also be capable of distally pushing with sufficient force a shorter product container in an engagement with the support element 11a, 14a of the present disclosure.
[0064] The syringe holder 11 of the first implementation and the adapter holder 15 of the second implementation may be provided for subsequent add-on functions in the assembled state. For this purpose, the second snap elements 11e, 15d of the respective syringe holder 11 and of the adapter holder 15 may engage in a complementary manner with second slot-shaped recesses 40c of the needle protection sleeve 40. In the starting position of the needle protection sleeve 40 (
[0065] The first, second and third snap elements 11d, 11e, 11f and 15c, 15d, 15e may each be provided in pairs on mutually opposite sides of their respective syringe holder 11 and of the adapter holder 15, where in each case, the use of only one element or multiple snap elements distributed over a periphery may also be provided as an alternative. The syringe holder 11 and the adapter holder 15 may be made of a plastic having, in comparison to the housing 10, different material properties, for instance to facilitate the formation of the elastic snap elements 11d, 11e, 11f and 15c, 15d, 15e. In contrast to the housing 10, the syringe holder 11 and the adapter holder 15 may also be optically transparent, and as a result, may facilitate protecting the product container from breakage or shattering without obscuring the visibility of the product through the recesses of the inspection windows 10a in the housing 10.
[0066]
[0067] As illustrated in
[0068] The centering, orientation and snap elements provided herein may also be attached on the respective other component. For example, a concentric distal elongation of the end cap 12 may be provided instead of an elongation of the housing 10, and/or the snap elements 10c of the housing 10 may instead be attached to or formed by the end cap 12 and engage in a corresponding opening of the housing 10. As an alternative to a continuous elongation provided along the housing periphery, axially oriented arms may alternatively be provided, which may protrude from the proximal end of the housing 10 or from the distal end of the end cap 12, may support the snap elements, e.g., snap elements 10c, and may ensure a centering and/or alignment of the end cap 12 during the assembly. Instead of the releasable holding cams 12c, other connection means such as engagement elements or bayonet and threaded connections may also be provided for the preassembly, and, instead of the snap elements 10c, non-releasable connectors may also be used.
[0069]
[0070] The spiral spring 62, e.g., a spring strip configured as a flat metal strip, may be anchored in the spring axis 61b and then be wound around the cylinder shaft 61 between the two end flanges 61a, 61c which flanges 61a, 61c may be permanently and firmly, e.g., non-detachably, connected to the spring axis 61b. Subsequently, the spring shaft 61 and the spiral spring 62 may be introduced in the proximal direction into the spring sleeve 63, and the spiral spring 62 may be connected to the spring sleeve 63. For this purpose, the outer end of the spiral spring 62 may include four openings, holes or eyelets 62a, which may lie next to one another along the spring axis in the spring strip, and the spring sleeve 63 may include four prongs or teeth 63a arranged next to one another in the form of a comb in the direction of the spring axis. The four prongs 62a of the spiral spring 62 may point in the spring tensioning direction and may be received by a complementary recess in the spring sleeve 63. The openings 62a of the spiral spring 62 may be pulled under slight tensioning of the spiral spring 62 via the prongs 63a of the spring sleeve 63 and may be hooked in or hooked on the prongs 63a. Due to the engagement of the toothing, an axial positioning of the spiral spring 62 with the spring sleeve 63 occurs.
[0071]
[0072]
[0073] Alternatively to the prongs 63a formed in the sleeve material of the spring sleeve 63, prongs or hooks protruding radially from the sleeve material may be attached or molded on the spring sleeve 63, e.g., on a sleeve jacket. If the prongs are applied to the inner side of the spring sleeve 63, recesses or slots in the sleeve material may need to be provided. The spring strip of the spiral spring 62 can also be led outward through the recesses, for instance by means of an outward leading stair step in the spring tensioning direction, so that the separate slot, e.g., slot 63b, in the spring sleeve 63 may be avoided. Likewise, more or fewer than four openings in the spiral spring 63 and prongs in the spring sleeve 63 may also be provided, and/or other forms of spiral spring 62 openings other than circular forms, such as openings formed with an edge parallel to the spring axis, together with corresponding hooks in the sleeve material of the spring sleeve 63, which may be configured to be wider. The number of openings in the spiral spring 62 may exceed the number of hooks in the spring sleeve 63. The openings, the recess and the web may be produced in a simple manner for instance punching or laser cutting from the spring strip of the spiral spring 62 and the sheet metal of the sleeve material of the spring sleeve 63.
[0074]
[0075]
[0076] In some implementations, the spring sleeve 63 may be formed from a metal sheet on which the locking catch 63c, which may be configured as a flexible arm, together with the tooth 63d and the control element 63e, may be formed by mechanical punching or laser cutting. On the free end of the arm of the locking catch 63c, the tooth 63d may be formed as a tab and may be bent inward and the control element 63e may be formed as a tab and may be bent outward. The stopping element 63g of the spring sleeve may also be cut out of the sleeve jacket of the spring sleeve 63 and may be bent inward. In the embodiments shown, two locking catches 63c and two stopping elements 63g with corresponding stops may be distributed over the periphery of the spring pack 6 and offset with respect to one another by 180° in each case. Here, it is also possible to provide only one locking catch 63c and/or stopping element 63g, or more than two locking catches 63c and/or stopping elements 63g.
[0077] After the spiral spring has been fully tensioned, the tooth 63d may be brought in engagement with the stop 61e, for example, by a plastic deformation of the arm of the locking catch 63c. Alternatively, an elastic deformation of the arm of the locking catch 63c is also conceivable, where the locking catch 63c may be blocked by the control element 63e by engagement with the stop 61e. The control element 63e may include least one engagement surface for the release element 71 for instance in the form of a threaded surface, a bevel or a wedge. The securing-releasing deflection of the control element 63e may occur in the radial direction as shown, or in the axial or tangential direction. The securing elements for rotational securing may also include a flexible locking catch on the spring shaft 61 and an abutment on the spring sleeve 63. The stop 61e or the locking catch 63c may also be positioned directly on the spring shaft 61, on an additional flange connected in a rotationally fixed manner to the flange, or on a spoke connected in a rotationally fixed manner to the shaft, at any desired radial distance from the spring shaft 61. The complementary locking catch or abutment may be brought to an appropriate distance from the spring axis 61b on a torque transmission means connected in a rotationally fixed manner to the spring sleeve 63. Likewise, the stopping element 63g of the spring sleeve 63 and the complementary counter-abutment 72 of the drive unit 7 may also be arranged at a small distance from the spring axis 61b. During the twisting of the spring pack 6, the release element 71 may also deflect or shift the control element 63e away axially instead of radially. The release movement of the control element 63e may also occur during the axial movement of the spring pack 6 and the drive unit 7, so that the subsequent twisting may be omitted. At least the proximal end flange 61a, as a radial boundary surface, may also be firmly connected to the spring sleeve 63 instead of the spring shaft 61.
[0078]
[0079] Instead of the spiral, clock or drive spring, the spring packs 6, 6′ may also include an energy store in the form of other tension, torsion or rotation springs, for example, a coil or helix spring wound from a spring steel, in which the potential energy necessary for the product discharge may be charged by applying a torque between the two spring ends. As an alternative to providing an autoinjector with a non-adjustable dose, the spring packs 6, 6′ may be provided in an automatic injection device configured with dose setting functions, also referred to as autopens.
[0080] The patent application publication WO2016/205963 described herein also discloses a spring pack that includes a spring shaft with a distal end flange, a spiral spring, a spring sleeve and a spring sleeve cover, which, depending on a spiral spring width, can be detachably fastened in different axial positions on the spring shaft. The spring shaft has an axially formed holding rib, in which the inner end of the spiral spring, configured as a holding tab, can be anchored in a rotationally fixed manner, and the spring sleeve has an axially oriented holding edge, on which the outer end of the spiral spring, which is configured as a holding tab, can be anchored in a rotationally fixed manner. The holding tab includes a holding tongue, which, in the case of a bending edge, is angled in the spring strip by more than 90° with respect to the spring tensioning direction and which faces in the direction toward the inner end of the spiral spring. For the anchoring, the holding tab is tensioned via the holding edge and, with relaxation of the spring tensioning, guided so that it hooks to the holding edge. The bending edge in the spring strip is stressed even more strongly by the twisting of the spring sleeve, which occurs after the anchoring relative to the spring axis for loading potential energy into the spiral spring.
[0081] A spring pack for an injection device according to prior approaches includes the following elements:
[0082] a spring shaft with a spring axis, a torsion or rotation spring, in particular a spiral or drive spring wound from a spring strip, and a spring sleeve, where the torsion spring is connected in a rotationally fixed manner by an inner end with the spring shaft and by an outer end with the spring sleeve in each case with respect to the spring axis;
[0083] a first and a second securing element, which are firmly arranged on the spring sleeve and on the spring shaft and, in engagement, secure the spring sleeve in a rotationally fixed manner relative to the spring shaft with respect to the spring axis, where the engagement can be released by a release movement of the first securing element;
[0084] a control element which, during the assembly of the spring pack, can be moved onto a drive unit of the injection device by a release element of the drive unit, so that the first securing element performs a release movement and a torque stored in the spring pack is coupled to the drive unit.
[0085] According to implementations of the present disclosure, the spring packs 6, 6′ may be further configured such that:
[0086] a) the outer end of the spiral spring 62, 62′ may form a loop or have an opening, which, with tensioning of the spiral spring 62, 62′ in a spring tensioning direction, e.g., by gripping, tensioning or guiding of the outer end of the spiral spring strip, may be hooked to a prong or a hook of the spring sleeve 63, e.g., prongs 63a;
[0087] b) the prong of the spring sleeve 63 may point in the spring tensioning direction and may be formed by a recess in a sleeve material of the spring sleeve 63;
[0088] c) the spiral spring strip of the spiral spring 62, 62′ may have a step in the region of the opening, and may have a step height which may be at least approximately equal to a thickness of the spiral spring strip of the spiral spring 62, 62′ and of the sleeve jacket of the spring sleeve 63;
[0089] d) the first securing element, e.g., the locking catch 63c of the locking sleeve 63, may perform a release movement in the direction of the spring axis; and/or
[0090] e) the spring strip of the spiral spring 62, 62′ may be arranged between two end flanges 61a, 61a′, 61c, 61c′ and may be connected in a nondetachable and/or axially fixed manner to the spring shaft 61, 61′.
[0091] With the disclosed spring packs 6, 6′, a group of modular spring pack assemblies may be provided, which may include a first and a second spring pack, such as spring packs 6, 6′, in which the first spring pack, e.g., spring pack 6, may include a first spring shaft with two firmly attached flanges, a first spiral spring which may be wound between the two flanges around the spring shaft and the width of which may correspond to the distance of the flange, and a spring sleeve which may surround the spiral spring; and in which the second spring pack, e.g., spring pack 6′, may include a second spring shaft with two firmly attached flanges, a second spiral spring, which may be wound between the two flanges around the spring shaft and the width of which may correspond to the distance of the flange, and a spring sleeve, which may surround the second spiral spring. The first and the second spring shafts, such as spring shafts 61, 61′ as well as the widths of the first and the second spiral springs, such as spiral springs 62, 62′ may be different, but the spring sleeve, such as spring sleeve 63, and thus the shape and the coupling elements with the drive unit 7 may be identical across the two spring packs. Springs having a different spring strip width may thus also be assembled in an administration device, and may avoid the need to otherwise adjust the device. Thus, identically constructed administration devices may be provided with the differing spring packs providing for an adjustment of the force to be exerted during the administration of a certain drug.
TABLE-US-00001 LIST OF REFERENCE NUMERALS 10 Housing 10a Recesses or inspection window 10b Holding portion 10c Snap element 10d Housing contour 10e Recess 11 Syringe holder 11a Support element 11b Finger 11c Holder sleeve 11d, e, f Snap element 11g Assembly supporting element 12 End cap 12a Opening 12b Cap contour 12c Holding cam 13 Mechanism holder 13a Holding spring portion 14 Adapter 14a Support element 14b Finger 14c Adapter body 15 Adapter holder 15a Holder sleeve 15b Holding portion 15c, d, e Snap elements/securing elements 2 Ready-to-use or pre-filled syringe 21 Syringe body 22 Syringe shoulder 23 Piston or stopper 24 Product receiving portion 25 Injection needle 26 Finger flange 27 Needle protection cap 72 Counter-abutment 30 Pull cap 31 Protection cap remover 40 Needle protection sleeve 40a Sleeve arm 40b, c Recess 41 Needle protection sleeve spring 42 Switching sleeve 43 Locking sleeve 50 Plunger rod 50a Recess 51 Holding element 51a Holding arm 51b, c Engagement element 51d Projection 52 Threaded rod 6, 6′ Spring pack 61, 61′ Spring shaft 61a, a′, c, c′ End flange 61b, 61b′ Spring axis 61d Extension 61e Stop 61f′ Intermediate flange 62, 62′ Spiral spring 62a, 62a′ Openings 63 Spring sleeve 63a Prong 63b Slot 63c Locking catch 63d Tooth 63e Control element 63f Holding structure 63g Stopping element 7 Drive unit 71 Release element 72 Counter-abutment