Abstract
An electronic add-on module for an injection device includes a longitudinal axis and a discharge button arranged at a proximal end and configured to be movable in a distal direction along the longitudinal axis for discharging a liquid medication out of a container of the injection device. The add-on module includes a sensor unit, a receiving region adapted to the shape of the housing of the injection device for placing on along the longitudinal axis thereof, and a holding mechanism configured to releasably secure the add-on module against moving axially relative to the injection device. The receiving region is configured such that the discharge button can be accessed or contacted when the add-on module is on the injection device. The add-on module comprises a release element configured to be moved solely on a plane perpendicular to the longitudinal axis in a release movement for releasing the holding mechanism.
Claims
1. An injection system, comprising: an injection device having a longitudinal axis and comprising a discharge button arranged at a proximal end thereof, the discharge button movable in a distal direction along the longitudinal axis for discharging a liquid medication from a container of the injection device; and an add-on module comprising a sensor unit, a receiving region adapted to a shape of a device housing of the injection device such that the receiving region is configured to be mounted on the injection device along the longitudinal axis, and a holding mechanism configured to releasably secure the add-on module when mounted to the injection device against moving axially relative to the injection device, wherein the receiving region is configured such that the discharge button can be contacted when the add-on module is mounted to the injection device, and wherein the add-on module comprises a release element, which in a release movement for releasing the holding mechanism, can be moved in a plane perpendicular to the longitudinal axis or in a direction at least approximately perpendicular to the longitudinal axis.
2. The injection system according to claim 1, wherein the release element is configured for a linear release movement.
3. The injection system according to claim 1, wherein the release element is provided in a distal half of the add-on module.
4. The injection system according to claim 1, wherein the add-on module comprises a handle, which is configured such that with one hand, a user can actuate the discharge button and at least partially cover the release element when gripping the handle in a first grip position.
5. The injection system according to claim 1, wherein the receiving region is configured to receive the injection device by inserting the injection device in the distal direction, and wherein the injection device comprises a holding surface directed proximally, which engages behind a holding element of the holding mechanism and holds the injection device proximally against a separating movement.
6. The injection system according to claim 5, wherein the injection device comprises a distal carpule holder for receiving the container, wherein the device housing is arranged proximal thereto and configured for receiving a delivery mechanism for discharging the liquid medication from the container, wherein the holding surface is formed by a protrusion or a recess on the carpule holder.
7. The injection system according to claim 5, wherein the release element assumes a stable release position at an end of the release movement.
8. The injection system according to claim 7, wherein by inserting the injection device into the add-on module, the release element executes a holding movement counter to the release movement.
9. The injection system according to claim 8, wherein the holding mechanism comprises a control element, which is moved under tension of a control spring when the injection device is inserted, thereby unblocking the holding movement of the release element.
10. The injection system according to claim 9, wherein the holding movement of the release element is driven by a return spring.
11. The injection system according to claim 5, wherein the injection device comprises at least one of protrusions or recesses, and wherein the add-on module comprises at least one of grooves in a lateral face of the receiving region, which correspond to the protrusions, or holding elements for engagement in the recesses, which correspond to the recesses, and further comprising a further injection device, which differs from the injection device only by the at least one of the protrusions or recesses and a medical indication.
12. The injection system according to claim 1, wherein the add-on module comprises a charging socket for connecting a charging cable configured for charging an energy store of the add-on module, wherein the charging socket is inaccessible when the injection device is inserted into the add-on module.
13. The injection system according to claim 12, wherein the charging socket opens into the receiving region, and wherein the add-on module comprises a lateral opening through which the charging cable can enter and be plugged into the charging socket.
14. The injection system according to claim 1, wherein the add-on module comprises a device cap detector for detecting a device cap when mounted on a carpule holder of the injection device, comprising a tilting element for converting a movement of a first leg end of the tilting element in a direction perpendicular to the longitudinal axis into a movement of a second leg end of the tilting element in an axial direction, and a switching element, which is actuated by an axial movement of the second leg end.
15. The injection system according to claim 1, wherein the add-on module comprises an injection device detector configured detecting when the injection device is inserted into the add-on module, the injection device detector comprising a switching element configured to be actuated by the release element in at least one of a locking movement counter to the release movement or in a subsequently assumed holding position.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] Implementations are described in connection with the appended figures, which are exemplary and are in no way to be interpreted as limiting. In the drawings:
[0034] FIG. 1 shows an injection device configured for variable dose delivery, according to the present disclosure;
[0035] FIGS. 2A and 2B show side and end views of a first variant of an add-on module with a sliding release element, according to the present disclosure;
[0036] FIGS. 3A and 3B show cross-sections of a first embodiment of the first variant of the add-on module configured for a force-fit engagement taken along line A-A of FIG. 2A, according to the present disclosure;
[0037] FIGS. 4A, 4B and 4C show three injection devices each with different protrusions or recesses;
[0038] FIGS. 5A and 5B show cross-sections of a second embodiment of the first variant of the add-on module configured with a form-fit engagement, according to the present disclosure;
[0039] FIGS. 6A, 6B, 6C and 6D show views of a third embodiment of the first variant of the add-on module configured with a form-fit engagement, according to the present disclosure;
[0040] FIGS. 7A and 7B show side and end views of a second variant of an add-on module configured with a rotating release element, according to the present disclosure;
[0041] FIGS. 8A and 8B show cross-sections of a first embodiment of the second variant of the add-on module configured with a form-fit engagement, according to the present disclosure;
[0042] FIGS. 9A and 9B show cross-sections of a second embodiment of the second variant of the add-on module configured with a form-fit engagement, according to the present disclosure;
[0043] FIGS. 10A and 10B show side and end views of a third variant of an add-on module with a push-button;
[0044] FIG. 11 shows a cross-section of a first embodiment of the third variant of the add-on module configured with a force-fit engagement, according to the present disclosure;
[0045] FIGS. 12A and 12B show cross-sections of a second embodiment of the third variant of the add-on module configured with a form-fit engagement, according to the present disclosure;
[0046] FIGS. 13A and 13B show end views of a third embodiment of the third variant of the add-on module configured with a form-fit engagement, according to the present disclosure;
[0047] FIGS. 14A and 14B show isometric and cross-section views of a fourth embodiment of the third variant of the add-on module configured with a form-fit engagement, according to the present disclosure;
[0048] FIGS. 15A and 15B show cross-sections of a first implementation with a form-fit engagement against protrusions;
[0049] FIGS. 16A and 16B show cross-sections of a second implementation with a form-fit engagement against recesses;
[0050] FIGS. 17A and 17B show partial cross-sections of a fifth embodiment of the third variant of the add-on module configured with a form-fit engagement, according to the present disclosure;
[0051] FIGS. 18A and 18B show two, partial longitudinal sections of a sixth embodiment of the third variant of the add-on module configured with a form-fit engagement, according to the present disclosure;
[0052] FIGS. 19A, 19B, 19C, 19D, 19E, 19F, 19G, and 19H show several different versions of protrusions and recesses; and
[0053] FIG. 20 shows an add-on module with an inserted charging cable.
DETAILED DESCRIPTION
[0054] The term, “medication” or “medical substance,” includes any flowable medical formulation which is suitable for controlled administration by means of a cannula or hollow needle—for example, a liquid, a solution, a gel, or a fine suspension containing one or more medical active ingredients. A medication can thus be a single active ingredient composition or a pre-mixed or co-formulated composition having several active ingredients from a single container. The term includes in particular drugs such as peptides (e.g., insulins, insulin-containing medications, GLP-1-containing and derived or analogous preparations), proteins and hormones, biologically-obtained or active ingredients, active ingredients based upon hormones or genes, nutrient formulations, enzymes, and further substances, both in solid (suspended) or liquid form. The term furthermore also includes polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies, and suitable base, auxiliary, and excipient substances.
[0055] FIG. 1 shows an isometric view of an injection device 1 with variable dose delivery, including an elongate device housing 10 with a longitudinal axis, a carpule holder 11, a dose selection button 12, a dose display 13, and a discharge button 14. The carpule holder 11 may include a cam 11a and an annular stop face 11b at the transition to the device housing 10. A distal end of the carpule holder 11 (on the left in FIG. 1) may include a thread for receiving a needle unit with an injection needle. A device or needle shield cap of the injection device 1 may engage in a snap connection with the cam 11a for covering the carpule holder 11. A possible area of a bearing face 10a on the upper side of the device housing 10 is shown by a dashed line. A label of the injection device may be applied to a lower side of the device housing 10 opposite the bearing face 10a.
[0056] FIGS. 2A and 2B show a first variant of an add-on module 2, according to the present disclosure, in a side view perpendicular to the longitudinal axis (FIG. 2A) and in an end view in the direction of the longitudinal axis (FIG. 2B) in a released state. The add-on module 2 may include a sleeve-shaped module housing 20 with a receiving region 20a for receiving the injection device from FIG. 1 by inserting the injection device 1 in the distal direction, or by pushing the add-on module 2 onto the injection device 1 in the proximal direction up to the stop with the stop face 11b. In the mounted state, a lateral face of the receiving region 20a of the module housing 20 may rest tightly at least against the bearing face 10a of the device housing 10. The add-on module 2 may also include a release element 21 configured as a slide, which may be moved in the direction of the upwards arrow (FIG. 2B), perpendicular to the longitudinal axis, from a holding state to the released state shown. The release element 21 may include two lateral gripping surfaces 21a, each having five ribs, which in the direction of the longitudinal axis, may include a length corresponding to the width of a finger. As a result, the release element 21 may be gripped by the thumb and forefinger of one hand and moved, e.g., pushed, perpendicular to the longitudinal axis. In the released state shown, the release element 21 may project beyond the module housing 20, whereas, in a holding state, the release element 21 and the module housing 20 may form a continuous surface, for instance without noticeable shoulders or transitions, which may be suitable for use as a handle for a user to grip the add-on module and injection device.
[0057] FIGS. 3A and 3B show cross-sections of the device housing 10 and module housing 20 perpendicular to the direction of the longitudinal axis and in a plane A-A of FIG. 2A, according to a first embodiment of the first variant of the present disclosure, in which the add-on module 2 is held on or fastened to the device housing 10 of the injection device 1 by means of a force-fit engagement. A metal clamp 22 of the add-on module 2 may be constructed of a metal strip with a width that does not exceed the axial length of the release element 21, and a length that does not fall below the circumference of the device housing 10. The metal strip may form a loop with a 270° curved section and two, partially intersecting ends 22a, 22b, each with a width of less than half the width of the strip, which may be offset in the axial direction. In the holding state (FIG. 3B), the curved section may rest tightly against the device housing 10, and the two ends 22a, 22b may be pretensioned crosswise in the opposite pretensioning directions, indicated by the two arrows. A force-fit engagement with a minimum static friction may be established between the device housing 10 and the curved section, and optionally via a radially-compressible section, of the module housing 20. This may prevent unintentional release of the add-on module 2 counter to the mounting direction, as may possibly be caused by axial forces exerted on the injection device 1 when a needle shield cap is mounted or a needle unit applied.
[0058] In a released state (FIG. 3A), the two ends 22a, 22b of the metal strip may be moved away from each other or spread counter to their respective pretensioning directions, and the curved section of the metal strip may rest less tightly against the device housing 10 when the force-fit engagement is released, so that the device housing 10 is movable relative to the add-on module 2. The movement of the two ends 22a, 22b may be controlled by a release wedge 21b of the release element 21—in the present case, by a web extending in the longitudinal direction, which may separate the two ends upwardly in the direction of the arrow during a release movement. If the metal clamp 22 is not pretensioned or pretensioned in a different direction, the release element 21 may compress the two ends 22a, 22b of the metal strip, even in the holding position. The clamp 22 may also include several windings from a correspondingly less wide strip, or may be constructed of wire.
[0059] FIGS. 4A, 4B and 4C show three injection devices 1 with different protrusions or recesses on the carpule holder 11 for use in establishing the form-fit engagement of an add-on module 2. In FIG. 4A, the protrusions 11c may have the shape of four radial extensions, widenings, or prominences of a flange which are distributed evenly over the circumference, which flange may also form the annular stop face 11b. In FIG. 4B, the protrusions 11c may have the shape of two lateral cams on opposite sides of the flange with respect to the longitudinal axis. The protrusions 11c may extend beyond the surface of the device housing 10 and may thus form proximally-directed holding surfaces for establishing a form-fit engagement with a holding element of the add-on module 2 and securing against unintentional release of the add-on module 2 counter to the mounting direction. The protrusions at FIG. 4A may include less than four and/or non-rotationally-symmetrically-arranged extensions, or may also be configured as a circumferential collar. FIG. 4C shows recesses 11d on the carpule holder 11 in the form of two parallel, lateral notches or slots. The two notches may be arranged distal to the flange, and may include holding surfaces extending inwardly relative to the surface of the carpule holder 11 and may be directed proximally for a form-fit engagement with a holding element of the add-on module 2. The protrusions and recesses may also be formed on the device housing 10 or further distally of the stop face 11b on the carpule holder 11. A suitably configured add-on module 2 may include grooves in the receiving region 20a that correspond to the protrusions 11c and extend parallel to the longitudinal axis, which grooves, in the case of protrusions on the flange, may extend almost over the entire length of the receiving region 20a. As a result, the injection device 1 and the add-on module 2 may be secured in a torque-proof manner against each other during mounting.
[0060] FIGS. 5A and 5B show a second embodiment of the first variant with a form-fit engagement with two of four protrusions 11c of the carpule holder 11, for instance as shown at FIG. 4A. FIGS. 5A and 5B show a section perpendicular to the longitudinal axis directly proximal of the flange, where the module housing 20 is, additionally, halved in the axial direction. The release element 21 may include a radially-displaceable holding element 21c, the innermost edge of which in the holding state (FIG. 5B) may engage behind the holding surfaces of two of the four protrusions 11c and, after the release movement has been completed, releases them in the direction of the arrow in the released state (FIG. 5A).
[0061] FIG. 6A shows, in an isometric view, a third embodiment of the first variant of the present disclosure configured for a form-fit engagement with the two lateral protrusions 11c on the flange of the carpule holder 11 according to FIG. 4B. The add-on module 2, in turn, may include a release element 21 in the form of a slider. In the area of a label of the injection device 1, e.g., opposite the bearing face 10a of the device housing 10, the module housing 20 may include a window 20c or an opening to the injection device. The module housing 20 may also include touch sensors 20b as provided herein. FIG. 6B shows a longitudinal section through the third embodiment in a released state. The radially-movable release element 21 may be pretensioned downwards or inwards by a return spring 23, and an axially-movable control element 24 may be pretensioned proximally by a control or ejection spring 25. The return spring 23 and the control spring 25 are shown as pressure-loaded compression springs; however, pretensioning of the release element 21 and the control element 24 may also be established by a tension spring or other elastic element.
[0062] FIGS. 6C and 6D shows a release element 21 with two parallel arms and a holding element on each arm, where only the arm 21d facing the observer is visible in the selected view. In the released state (FIG. 6D), a locking cam 24a of the control element 24 is engaged in a recess 21e of the release element 21, so that the release element 21 is blocked against movement downwards despite being pretensioned by the return spring 23. As soon as the injection device is inserted from the proximal direction and pushes the control element 24 distally, with the stop face 11b or the protrusions 11c under compression of the control spring 25, the locking cam 24a is pushed axially out of the recess 21e, and the release element 21 is released. The release element 21 is pushed downwards by the return spring 23 and, in the holding state, engages with its holding elements 21c behind the lateral protrusions 11c on the injection device (FIG. 6C). The engagement of a distally-directed holding surface of the holding element 21c behind the proximally-directed holding surfaces of the protrusions 11c on the injection device locks the add-on module 2, relative to the injection device 1, in the holding state. To release the add-on module 2, the release element 21 may be pulled upwards, away from the longitudinal axis at its lateral gripping surfaces 21a until locking by the holding elements 21c is released, and the locking cam 24a snaps into place again. The control spring 25 may relax and push the injection device out of the add-on module.
[0063] FIGS. 7A and 7B show a second variant of an add-on module 2 according to the present disclosure in a side view perpendicular to the longitudinal axis (FIG. 7A) and in an end view in the direction of the longitudinal axis (FIG. 7B) in a released state. The add-on module 2 may include a sleeve-shaped module housing 20 with a receiving region 20a for receiving the injection device of FIG. 1 by inserting the injection device 1 in the distal direction or by pushing the add-on module 2 onto the injection device 1 in the proximal direction up to the stop with the stop face 11b. In the mounted state, a lateral face of the receiving region 20a rests tightly at least against the bearing face 10a of the device housing 10. The add-on module 2 may include a release element 21 configured as a control lever, which may be rotated or turned in a plane perpendicular to the longitudinal axis from a holding state to the released state. The release element 21 may include a gripping surface 21a on all sides with parallel ribs which, in the direction of the longitudinal axis, and may have a length corresponding to the width of a finger. As a result, the release element 21 may be gripped by the thumb and forefinger of one hand and be rotated, turned, tilted, or pivoted perpendicularly to the longitudinal axis. In the holding state, the release element 21 and the module housing 20 may form a continuous surface without noticeable shoulders or transitions, which may be suitable as a handle for a user to grip the add-on module and injection device.
[0064] FIGS. 8A and 8B show cross-sections perpendicular to the direction of the longitudinal axis taken along plane A-A of FIG. 7A, and, distally, in the direction of view, a first embodiment of the second variant with a form-fit engagement against three protrusions 11c on the carpule holder 11. At least the tips of the protrusions 11c may project radially beyond a device housing 10 or carpule holder 11 surface surrounding them. The release element 21 may include three, inwardly-pointing holding elements 21c in the form of projections, which may be distributed over an inner circumference in accordance with the arrangement of the protrusions 11c and may be connected to the release element 21 in a rotationally-fixed manner and for instance the release element 21 may be configured as an adjusting ring. In the holding state (FIG. 8A), the holding elements 21c may be in a form-fitting relationship to the protrusions 11c, and may thus prevent a movement of the add-on module 2 in the distal direction. Through a rotation by at most 60°, the protrusions 11c may be released by the release element 21 for a movement in the proximal direction (FIG. 8B).
[0065] FIGS. 9A and 9B show cross-sections perpendicular to the direction of the longitudinal axis in the direction of view distal of a first embodiment of the second variant with a form-fit engagement against two protrusions 11c on the carpule holder 11. In this embodiment, the release element 21 may be configured as a circular adjusting ring with a circumferential gripping surface 21a. FIG. 9B shows a released state, while FIG. 9A shows a holding state. During the transition from the released to the holding state, two radially-movable-mounted guide cams 21g may be pushed inwards in the direction of the arrow by a 45° clockwise rotation of the adjusting ring and by means of two eccentric guide notches 21f coupled to the adjusting ring in a rotationally-fixed manner. The guide cams 21g may be coupled to radially-movable holding elements at least in the radial direction or may be formed integrally therewith, so that the holding elements also move inwards and engage behind the protrusions 11c. A rotational movement of the release element 21 may also be implemented or deflected by another slide control system or a wedge into the radial movement of a holding element instead of by the guide notches, where the guide cams may also be attached in a radially-fixed manner to the adjusting ring and may be provided on the holding element for interacting with an eccentric guide notch.
[0066] Further embodiments of the second variant relate to a combination of a tilting or rotating release element, as shown herein, with a force-fit engagement on the device housing 10. A clamping force necessary for this engagement may be produced by a pretensioned metal strip, as described in connection with FIGS. 3A and 3B, where an end of the metal strip with the release element may be rotated against the other end of the metal strip that is connected to the module housing, in order to release the force-fit engagement. Alternatively, brake shoes, e.g., in place of the holding elements from FIGS. 9A and 9B, may be pressed radially onto the surface of the housing of the injection device 1 via guide cams and eccentric guide notches.
[0067] FIGS. 10A and 10B show a third variant of an add-on module 2 according to the present disclosure in a side view perpendicular to the longitudinal axis (FIG. 10A) and in an end view in the direction of the longitudinal axis (FIG. 10B) in a released state. The add-on module 2 may include a sleeve-shaped module housing 20 with a receiving region 20a for receiving the injection device from FIG. 1 by inserting the injection device 1 in the distal direction or by pushing the add-on module 2 onto the injection device 1 in the proximal direction up to the stop at the stop face 11b. In the mounted state, a lateral face of the receiving region may rest tightly at least against the bearing face 10a. The add-on module 2 may also include a release element 21 configured as a push button, which may be moved perpendicularly to the longitudinal axis from a holding state to the released state shown. The release element 21 may include an upwardly-directed square or round pressure receiving or operating surface with a length corresponding to a fingertip of a user—such as at least 0.5 cm.sup.2. As a result, the release element 21 may be pressed downwards in the direction of the arrow perpendicular to the longitudinal axis in a release movement. In the holding state, the release element and the module housing 20 may form a continuous surface without noticeable shoulders or transitions, which may provide a handle or grip for a user to grip the add-on module and injection device. In this case, the pressure receiving or operating surface of the release element 21 may differ from the planar shape shown and may also include an edge at the transition to an inclined, side surface section of the module housing 20. In a released state, the release element 21 for instance configured as the push button may project beyond the module housing 20 as shown, may be recessed in relation to the surface of the module housing, or may, as a push button, also assume the same position as in the holding state.
[0068] FIG. 11 shows a cross-section perpendicular to the direction of the longitudinal axis in a plane A-A according to FIG. 10A of a first embodiment of the third variant with a force-fit engagement, according to the present disclosure. A metal clamp 22 may be formed from a metal strip with a width, which may not exceed the axial length of the release element 21, and with a length which may not fall below the circumference of the device housing. The metal strip may form a loop with a 320° curved section and two ends 22a, 22b angled therefrom. In the holding state shown, the curved section rests tightly against the device housing 10, and the two ends 22a, 22b are pretensioned or pushed in the opposite pretensioning directions that are indicated by the two arrows. A force-fit engagement with minimum static friction may be produced between the device housing 10 and the metal strip—optionally, via a radially-compressible section of the module housing 20.
[0069] In a released state, the two ends 22a, 22b of the metal strip may be moved away from each other or spread apart counter to their respective pretensioning direction, and the curved section of the metal strip may rest less tightly against the device housing 10 when the force-fit engagement is released, so that the latter is movable relative to the add-on module 2. Movement of the two ends 22a, 22b may be controlled by a release wedge 21b of the release element 21, and in the present case by a wedge-shaped web extending along the longitudinal direction, which may separate the two ends 22a, 22b counter to their pretensioning when a user presses the release element 21, and the latter executes a release movement in the radial direction.
[0070] FIGS. 12A and 12B show cross-sections perpendicular to the direction of the longitudinal axis in a plane A-A according to FIG. 10A in the distal direction of view of a second embodiment of the third variant with a form-fit engagement against two lateral protrusions on the carpule holder 11 according to FIG. 4B. The release element 21 may include two parallel arms at a distance corresponding to the diameter of the injection device. Included at the end of each arm may be a holding element 21c, which may engage behind one of the protrusions 11c on the carpule holder 11 in the holding position (FIG. 12A). Upstream of the holding elements 21c, release elements or recesses in the arms may be provided, which, in the released state (FIG. 12B), may be aligned with the protrusions 11c after a pressing movement to release the protrusions 11c. The release element 21 may be pretensioned by a return spring 23 into the holding position, which may be compressed during a release movement to the released state.
[0071] In the proximal direction of view, FIGS. 13A and 13B show cross-sections perpendicular to the direction of the longitudinal axis in a plane A-A according to FIG. 10A according to a third embodiment of the third variant with a form-fit engagement against four protrusions on the carpule holder according to FIG. 4A. One half of the module housing 20 and the push button of the release element 21 are shown in an axial view. The flange on the carpule holder 11, in turn, includes four protrusions 11c that are evenly distributed. The release element 21 may include a holding element 21c, which may engage behind two protrusions 11c on a side of the injection device opposite the push button when the release element 21 is pushed into the holding position (FIG. 13A) by the return spring 23.
[0072] FIGS. 14A and 14B show a fourth embodiment of the third variant with a form-fit engagement to the injection device, according to the present disclosure. The add-on module 2 shown at FIG. 14A in an isometric view, includes a release element 21 in the form of a push button as well as touch sensors 20b described further herein. In the area of a label of the injection device, the module housing 20 has a window 20c or an opening, e.g., opposite the bearing face. FIG. 14B, shows a longitudinal section of FIG. 14A in a released state. The upwardly-directed pressure receiving or operating surface of the release element 21 is shown as lowered relative to a surface of the surrounding module housing 20, e.g., by at least 1 mm. The release element 21 may be pretensioned upwards by a return spring 23 counter to the direction of pressure exerted by the user, and an axially-movable control element 24 may be pretensioned proximally by an ejection or control spring 25. The control element 24 may be annular and the injection device may be inserted therethrough. The return spring 23 and the control spring 25 are shown as pressure-loaded compression springs; however, pretensioning of the release element 21 and the control element 24 may also be accomplished by a tension spring or other elastic element.
[0073] FIGS. 15A and 15B show a first implementation of the fourth embodiment of the third variant according to the present disclosure with a form-fit engagement against two lateral protrusions 11c of the carpule holder 11 according to FIG. 4B. The release element 21 may include two parallel arms and a holding element on each arm, where, as shown, only the arm 21d facing the observer is visible, and the associated holding element 21c is located on the inside of the arm 21d. In the released state (FIG. 15B), a protrusion in the form of a locking cam 24a of the control element 24 may be engaged in a recess 21e of the release element 21, so that the latter is blocked against movement upwards, despite being pretensioned by the compression spring 23. As soon as the injection device is inserted from the proximal direction and pushes the control element 24 distally with the stop face 11b or the protrusions 11c, under compression of the control spring 25, the locking cam 24a may be pushed axially out of the recess 21e, and the release element 21 may thus be released. The release element 21 may be pushed upwards by the return spring 23 and engage with its holding elements 21c behind the lateral protrusions 11c on the injection device (FIG. 15A). As a result, the add-on module 2 may be locked in the holding state relative to the injection device.
[0074] To release the add-on module 2, the release element 21 may require being pressed downwards by pressing the pressure surfaces towards the longitudinal axis until the locking is released by the holding elements 21c, or release elements or recesses in the arms are aligned with the protrusions 11c, analogously to the embodiment according to FIGS. 12A and 12B. The locking cams 24a may snap into place again, and the control spring 25 may relax and push the injection device out of the add-on module 2. Alternatively, the locking cam 24a may also be provided on the release element 21 and engage in a recess of the control element 24. For tolerance reasons, in the holding state, further compression of the control spring 25 or a small axial movement of the injection device, of its protrusions, and of the control element 24 in the distal direction relative to the holding elements 21c of the release element 21, and thus to the module housing 20, may not be ruled out. In accordance with the present disclosure, however, even when such movement is present, with a tolerance-related or intended path or movement between one tenth and one millimeter, the add-on module is considered to be axially held relative to the injection device.
[0075] FIGS. 16A and 16B show a second implementation of the fourth embodiment of the third variant of the present disclosure with a form-fit engagement against recesses on the carpule holder in the form of two, parallel, lateral notches according to FIG. 4C. The two notches 11d are arranged after the flange in the distal direction and replace the lateral protrusions of the first implementation. As shown in the longitudinal sections in FIGS. 16A and 16B in the released state (FIG. 16B), and as further differing from the first implementation, the control element 24 includes a proximally-directed extension 24b in the form of several plungers or pins. A proximal end of the extension 24b strikes the stop face 11b on the carpule holder 11 of the inserting injection device and pushes the control element 24 distally. In the holding state (FIG. 16A), locking cams of the control element 24 release the release element 21 for an upwards movement, as a result of which holding elements of the release element 21 are inserted into the notches. Due to the extension 24b, the movements of the control element and of the release element can be easily coordinated with one another; for example, it may be ensured that the holding element 21c is released for the locking movement only when the notch 11d has advanced sufficiently in the distal direction.
[0076] FIGS. 17A and 17B show longitudinal views of a fifth embodiment of the third variant with a form-fit engagement against two lateral protrusions of a carpule holder according to FIG. 4b in accordance with the present disclosure. In contrast to the fourth embodiment of FIGS. 15A and 15B, in this embodiment, the return spring and the control spring are combined in a single spring, and the control element is mounted in a rotatable instead of in an axially-displaceable manner. As shown in the released state at FIG. 17A, the control element 24 has an axis of rotation 24c, with which the control element 24 is rotatably anchored in the module housing 20, and about which it can be tilted from the release position to a holding position (FIG. 17B) when the injection device is pushed distally relative to the module housing 20. For this purpose, the opening for the injection device formed by the control element 24 may be configured to be slightly oval in a direction perpendicular to the axis of rotation 24c. The release button 21, in turn, may include two, lateral, parallel arms with recesses into which locking cams of the control element 24 may engage in the release position, and with holding elements which, in the holding state, may engage behind the protrusions 11c. A leg spring 26 may press the push button of the release element 21 upwards with a first leg 26a, and press the control element 24 in the proximal direction with a second leg 26b. In the release position, the pressure surface of the release element 21 may be recessed, and the leg spring 26 may be tensioned. In the holding position, the control element 24 may be oriented to be perpendicular to the longitudinal axis, the pressure surface of the release button 21 may be flush with the surface of the module housing 20, and the leg spring 26 may be slightly relaxed, since a tensioning movement of the first leg 26a may be exceeded by a relaxation of the second leg 26b. In this embodiment, too, by pressing the release button 21, the locking of the protrusions 11c may be released, the injection device may be pushed proximally, and the release button 21 may be locked in the pushed-in release position (FIG. 17A).
[0077] FIGS. 18A and 18B show partial longitudinal cross-sections of a sixth embodiment of the third variant with a form-fit engagement against two lateral protrusions of a carpule holder according to FIG. 4B, in a release position according to the present disclosure. As in the preceding fifth embodiment, the control element 24 may be rotatably mounted and, as in the fourth embodiment of FIGS. 15A and 15B, the return spring 23 and the control spring 25 may be separated and thus individually adjustable in this embodiment. As shown at FIG. 17A, the control element 24 in FIGS. 18A and 18B also has an axis of rotation 24c in a lower side, opposite the release button 21, with which it is rotatably anchored in the module housing 20, and about which the control element 24 may be tilted from the release position shown, to a holding position, when the injection device is pushed distally relative to the module housing 20. The control spring 25 may be a non-planar spring ring or a spring clip with an opening for the injection device, which may be supported, in each case on two points, opposite one another with respect to the longitudinal axis, on the module housing 20 or on the control element 24. The release button 21, in turn, may include two, lateral, parallel arms 21d with recesses 21e into which locking cams 24a of the control element 24 may engage in the release position, and with holding elements which, in the holding state, may engage behind the protrusions 11c of the injection device. The return spring 23 may be a pressure-loaded compression spring.
[0078] FIG. 18A shows a device cap detector with a tilting element 27, which is configured to tilt about a pivot point 27a as soon as the device cap, in the proximal direction (from the left in FIGS. 18A and 18B), is either mounted on the carpule holder 11 of the injection device inserted in the add-on module 2, or is removed therefrom. A first or distal leg 27b of the tilting element may be held in an approximately axial orientation by the return spring 23 and may be pushed upwards (in the direction of the arrow) from this position by a proximal edge of the device cap. As a result, one end of a second or radial leg 27c of the tilting element 27, which is arranged at an angle of approximately 90° relative to the first leg, may be moved substantially in the proximal direction, which may be detected by a switching element 28a actuated in the axial direction.
[0079] FIG. 18B, shows an injection device detector, which may include an axially-aligned lever 21h on the release button 21, and a switching element 28b. Due to an inserted injection device, the release button 21 may, as described, be released for a radial movement perpendicular to the longitudinal axis (e.g., upwards in FIG. 18B); the corresponding movement or end position of the lever 21h may be detected by the switching element 28b. The presence of the injection device may thus be detected only at the very end of the insertion movement, and not only after partial insertion. The injection device detector may be provided alternatively or additionally to the device cap detector. The switching elements 28a, 28b may include electronic micro switches, sliding contacts, or optical detectors; which may be arranged on a printed circuit board fixedly mounted in the module housing 20.
[0080] FIGS. 19A-19E show five different versions of the protrusions 11c on the flange of the carpule holder, starting with the version of FIG. 4B as FIG. 19A. The five versions of the protrusions 11c differ with respect to the number of protrusions, their arrangement or distribution over the circumference of the carpule holder, and their shape in the shown sectional plane perpendicular to the longitudinal axis. The shape includes both a width or length in the circumferential direction, a height or extension in the radial direction, as well as a contour of the individual protrusions, and, for instance, differ from a perfectly radial or circular contour section. In some implementations, however, no protrusion is provided in the angular range of the bearing face on the injection device, e.g., over a corresponding angular segment of at least 120°, or at least 90°. As a result, the lateral face of the receiving region, which rests tightly against the bearing face in the holding state is not impaired by a groove for axial guidance of a protrusion.
[0081] FIGS. 19F-19H show in cross-sections perpendicular to the longitudinal axis, three different versions of recesses 11d on the carpule holder 11, together with the release element 21 of an add-on module 2 suitable to receive the carpule holder 11 and its recesses 11d. The release element 21 may form an opening for the injection device and may function with a return spring analogous to the embodiment of FIGS. 12A and 12B. The release element 21 may include a section opposite the push button with inwardly-directed protrusions as holding elements for engaging the recesses 11d of the carpule holder 11.
[0082] An add-on module, which corresponds or is adapted to one of FIGS. 19B-19E, cannot be mounted on an injection device with one of the other versions. At best, an injection device, with the configuration of FIG. 19A, may be inserted into an add-on module 2 for the FIG. 19B. Thus, in the sense of a key-lock principle, unambiguous assignments of injection devices to add-on modules may be generated. Individualized protrusions or recesses may prevent an add-on module from being intentionally or, if, for example, several injection devices are being used in the surroundings of a patient, accidentally mounted on a wrong injection device. A wrong injection device in the present context is an injection device which, except for the mentioned differences in the protrusions or recesses, is identical, but is provided for another medical indication. Differences in the medical indication include different active substances, formulations, shelf lives, therapies, and/or patients, and the corresponding information on the label. The protrusions may, in turn, also be arranged on the housing of the autoinjector or at another location of the carpule holder, where at least the axial arrangement of those protrusions, which are not engaged from behind by a holding element of the release element, can, for purely axial insertion movements, be arbitrary. In general, the mounting of an unsuitable add-on module may already be prevented, depending, however, upon the axial arrangement of the protrusions or, in the case of recesses, even the movement of the holding elements during an attempted transition to the holding state.
[0083] FIG. 20 shows a longitudinal cross-section through an add-on module 2 with an inserted charging cable 3 for charging or recharging an energy store of the add-on module 2 and/or for data exchange with a third-party device. The add-on module 2 may include a charging socket for receipt of a charging plug 31 of the charging cable 3, e.g., a USB-C port, which may be accessible solely from the receiving region 20a, or may be contacted solely by a user with a standard charging cable. Accordingly, the charging socket may be covered by an injection device inserted in the receiving region, and may thereby ensure that a charging cable must be removed again before the add-on module 2 is put into operation or before the injection device is inserted therein. The charging plug 31 may be inserted in a straight line through the opposite window 20c of the module housing 20 and transversely through the receiving region 20a. The size of the window 20c may correspond at least to a readable area of a label on the injection device and may thus provide sufficient space for manipulation of the charging cable—e.g., for gripping the charging plug 31 with two fingers. An alternative solution for preventing insertion of the charging plug 31 when the injection device is inserted may include movement of the charging socket at least partially behind an aperture in the surface of the module housing 20 when the injection device is inserted, or a bi-stable cover which, in order to release the charging socket, may be moved in front of an axial access to the receiving region solely and only when the injection device is missing from the add-on module 2.
[0084] As shown at least at FIG. 14A, the add-on module 2 may include touch sensors 20b. These touch sensors 20b may serve to detect when the add-on module is touched and for instance gripped. In the mounted state, an upcoming manipulation may inferred therefrom, and a sensor state, for example, may be activated. For this purpose, any conceivable possibility of gripping the add-on module may be reliably detected, e.g., not only a grip with the whole hand, but for instance also a grip in the manner of a pair of tweezers, with only two fingers on opposite sides of the add-on module. The add-on module may therefore include sensor regions on surfaces of both sides, on the top surface, and on the end faces. Exemplary capacitive touch sensors may be preferably affixed as a label to the module housing or encased as a film with the material of the module housing in an injection molding process. In addition to a touch sensor, the device cap detector from FIGS. 18A and 18B herein may also be used for detecting a mounted or removed device cap for an anticipated change of state of the add-on module.
TABLE-US-00001 LIST OF REFERENCE SIGNS 1 Injection device 10 Device housing 10a Bearing face 11 Carpule holder 11a Cam 11b Stop face 11c Protrusion 11d Recess 12 Dose selection button 13 Dose display 14 Discharge button 2 Add-on module 20 Module housing 20a Receiving region 20b Touch sensor 20c Window or opening 21 Release element 21a Gripping surface 21b Release wedge 21c Holding element 21d Arm 21e Recess 21f Guide notch 21g Guide cam 21h Lever 22 Metal clamp 22a, b Ends 23 Return spring 24 Control element 24a Locking cam 24b Extension 24c Axis of rotation 25 Control spring 26 Leg spring 26a, b Spring leg 27 Tilting element 27a Pivot point 27b, c Lever leg 28a, b Switch 3 Charging cable 31 Plug
