ELECTRONIC ADD-ON MODULE FOR INJECTION DEVICES
20210187200 · 2021-06-24
Inventors
Cpc classification
A61M5/3157
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
A61M2005/3143
HUMAN NECESSITIES
A61M5/24
HUMAN NECESSITIES
International classification
Abstract
Implementations relate to an electronic add-on module releasably attachable to an injection device prior to injection, a sensor element for detecting a state or process in the injection device, a processor element for evaluating and/or processing a signal of the sensor element, and an energy store for supplying the processor element with energy. The add-on module has a first module part, which is connectable along its longitudinal axis to the injection device in an axially fixed manner by means of a holding mechanism. A second module part is movable for a damped relative movement, such as a deceleration or braking movement, by a delay stoke with respect to the first module part connected to the injection device. By damping a relative movement between two module parts, the force transmission between the add-on module and the injection device is controlled and a maximum force surge is limited to the injection device.
Claims
1. An add-on module configured to be mounted on an injection device with a longitudinal axis, the add-on module comprising: a sensor element for detecting a state of the injection device; a processor for evaluating a signal of the sensor element; an energy storage device for supplying energy to the processor; a first module part which, in the direction of the longitudinal axis, is configured to be connected to the injection device in an axially fixed manner; and a second module part which is configured to be moved in a distal direction of the longitudinal axis for a relative movement with respect to the first module part when connected to the injection device in an axially fixed manner.
2. The add-on module according to claim 1, wherein the second module part has a greater mass than the first module part.
3. The add-on module according to claim 1, wherein the sensor element is arranged in the first module part.
4. The add-on module according to claim 1, wherein the add-on module further comprises a damping element for damping the relative movement.
5. The add-on module according to claim 4, wherein the second module part comprises a stop which, at an end of a damped relative movement, can hit a deceleration end-stop of the injection device or of the first module part.
6. The add-on module according to claim 4, wherein the damping element comprises a spring element which is preloaded when the add-on module is connected to the injection device.
7. The add-on module according to claim 4, wherein the first module part comprises an internal space and the damping element performs a damped relative movement within the internal space.
8. The add-on module according to claim 1, wherein the first module part includes a receiving unit and the second module part includes a module housing which surrounds the receiving unit.
9. The add-on module according to claim 8, wherein the second module part comprises a handle for gripping the injection device and the add-on module.
10. The add-on module according to claim 8, wherein the add-on module further comprises a damping element for damping the relative movement, the second module part comprises a stop which, at an end of a damped relative movement, can hit a deceleration end-stop of a needle protection cap remover of the injection device.
11. The add-on module according to claim 10, wherein the first module part comprises a holding element and the second module part comprises a release unit, wherein, in a holding configuration, the add-on module limits a distal movement of the receiving unit in the module housing by the release unit, and the holding element holds the injection device in the receiving unit; and in a release configuration, the add-on module releases the receiving unit from the release unit and releases the injection device from the holding element, wherein, by a release movement of the receiving unit, the add-on module can be moved from the holding configuration into the release configuration.
12. The add-on module according to claim 11, wherein the release unit comprises a guiding cam, and the receiving unit or the injection device comprises a locking cam, wherein, in the holding configuration, the guiding cam assumes a holding position and cooperates with the locking cam such that the receiving unit and the injection device are prevented from moving in the distal direction.
13. The add-on module according to claim 12, wherein the guiding cam is configured to be moved from the holding position into a release position in which the locking cam is released from the guiding cam, and wherein the guiding cam is preloaded into its holding position by a release button spring.
14. The add-on module according to claim 11, wherein the add-on module comprises a release assistance system, wherein when the release unit is actuated, the release assistance system is first tensioned and subsequently relaxed when the receiving unit is shifted with respect to the module housing.
15. A method of using an injection device comprising a device housing with a longitudinal axis, the device housing comprising recesses for coupling to an add-on module, the add-on module comprising: a sensor for detecting a state of the injection device; a processor for evaluating a signal of the sensor element; an energy storage for supplying energy to the processor element; a first module part which, in a direction along the longitudinal axis, can be connected to the injection device in an axially fixed manner via the housing recesses; and a second module part which can be moved in a distal direction of the longitudinal axis for a relative movement with respect to the first module part which is connected to the injection device, wherein the method comprises connecting the injection device to the first module part via the device housing recesses.
16. An add-on module, the add-on module comprising: a sensor element for detecting an injection state; a processor for evaluating a signal of the sensor element; an energy storage device for supplying energy to the processor; a first module part which, in a direction of a longitudinal axis of the add-on module, is configured to be axially affixed to an injection device housing; a second module part which is configured to be moved in a distal direction along the longitudinal axis for a relative movement with respect to the first module part when the first module part is axially affixed in a holding configuration; and a damping element arranged between the first module part and the second module part for damping the relative movement, wherein as the first module part is axially affixed, the damping element is preloaded by a receiving path in which the first and second module parts are shifted with respect to one another along the longitudinal axis, and wherein the second module part comprises a guiding cam and the first module part comprises a locking cam, wherein, in the holding configuration, the guiding cam cooperates with the locking cam such that the first module part is prevented from a movement in the distal direction along the longitudinal axis, and is permitted to move in a proximal direction along the longitudinal axis in a damped relative movement under further loading of the preloaded damping element.
17. The add-on module according to claim 16, wherein in the holding configuration, the add-on module is configured such that a distally directed stop surface of the second module part is opposite a proximally directed deceleration end-stop surface of a needle protection cap remover, and the stop surface strikes the deceleration end-stop surface at an end of the damped relative movement.
18. The add-on module according to claim 16, further comprising a release unit comprising a release button with an actuation surface movable in a radial direction relative to the longitudinal axis by a release movement to release the first module part from the holding configuration such that the add-on module is in a release configuration.
19. The add-on module according to claim 18, wherein the add-on module is configured to be moved from the release configuration into the holding configuration by a receiving movement along the receiving path.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] In connection with the appended figures, implementations of the present disclosure are described below. They are intended to show basic possibilities of the implementations and should not be interpreted as limiting.
[0028]
[0029]
[0030]
[0031]
[0032]
[0033]
[0034]
[0035]
[0036]
[0037]
[0038]
[0039]
[0040]
DESCRIPTION OF THE FIGURES
[0041]
[0042] The add-on module 2 has an elongate sleeve-shaped module housing 20 with an internal volume configured for receipt of the injection device 1, e.g., the module housing 20 is adapted to receive an outer shape of the device housing 10. The add-on module 2 may thus serve as a carrier component of the injection device 1, so that the injection device 1 can be inserted into the add-on module 2 for coupling the injection device 1 thereto. The add-on module 2 includes an actuation surface 51 for decoupling (or release) from the injection device 1. The add-on module 2, on a proximal end, includes an indicator light (e.g., via a light guide 65 and light sources of the electronics unit 60 described herein) for providing an optical state display for visual feedback to a user. As illustrated in
[0043] In the distal direction, the add-on module 2 includes two links 20b or longitudinal arms which are slightly bent outward on their distal end and connected to one another by stabilizing stop ridges 20c. Between the links and limited by the stop ridges 20c, lateral longitudinal openings 20d are formed, which in the coupled state to the injection device 1, are aligned with the windows 10a of the device housing 10 and allow a user to view a substance stored in the injection device 1. In a state without the inserted injection device 1 (
[0044] The device housing 10 and the module housing 20 may have an approximately square shape in cross section, wherein each side of the square is curved slightly outward. In the following description, for the sake of simplicity, a direction from the middle longitudinal axis of the housing 20 outward is referred to as radial direction.
[0045]
[0046]
[0047] Variant one (V1,
[0048] In variant two (V2,
[0049] In variant three (V3,
[0050]
[0051] The upper and the lower housing halves 21a, 21b each have an approximately semi-circular shape, and they are nondetachably snapped on and/or connected to one another, e.g., by ultrasound welding, laser welding, gluing or bolting. Due to the shape of the housing halves, an internal space is formed between them. On a proximal end, the internal space is limited by the housing closure 22 or a closure wall between the housing halves. On the distal end, the housing halves form an opening toward the internal volume or space. In the internal space, the housing insert 30, the release button 50 and the electronics unit 60 are arranged in an axially non-movable manner. In a middle region between the gripping region 20a and the links 20b (
[0052] The receiving unit 40 is mounted in an axially movable manner in the module housing 20, as described below, and furthermore comprises sensor elements, which may be in the form of two inductive sensor elements or sensor coils 41a, 41b which are arranged in corresponding circumferential grooves in an outer surface of the receiving unit 40. The sensor coils 41a, 41b are contacted or electrically connected on a shapeable or flexible carrier via a circuit board 41c, which may be in the form of a printed circuit board, including a flexible conductor 41d (also known as flexprint). Laterally between the two inductive sensor coils 41a, 41b, the circuit board 41c can comprise a NFC (Near Field Communication) coil for reading information of an RFID (Radio Frequency Identification) label on the injection device. A flexible connection 41d in the form of a wire, a cable, or, as represented, as a continuation of the circuit board 41c, e.g., printed conductor tracks of the mentioned flexible conductor 41d for the transmission of signals of the sensor coils 41a, 41b and of the NFC coil leads to circuit boards 64a, 64b (e.g., processor elements) of the electronics unit 60. The flexibility of this signal connection allows compensation of the varying axial spacing between the receiving unit 40 and the electronics unit 60.
[0053] The electronics unit 60 is arranged in a proximal region of the internal space in such a manner that it directly adjoins the housing closure 22 and comprises an electronics holder 61, an energy storage with battery 62 and accumulator/rechargeable battery 63, a first and a second circuit board 64a, 64b with light sources and processor elements for processing signals of the sensor coils 41a, 41b, for actuating the light sources, and for communication with additional external devices. The electronics unit 60 moreover comprises a light guide 65 which guides the light of the light sources to the surface of the module housing 20, and an antenna 66 for setting up a communication connection with a third device, in particular for out-of-band pairing for initiating a Bluetooth or other wireless connection.
[0054] Between a proximal end surface of the receiving unit 40 and a distal end surface of the electronics holder 61 (the end surfaces may be oriented at a right angle with respect to the longitudinal axis of the housing), is an elastic damping element 70 in the form of a compressed or compressible coil spring. The damping element 70 pretensions the receiving unit 40 in the distal direction via the end surface. The damping element 70 can also be provided between other components of the module housing 20 and of the receiving unit 40 or of the injection device 1 in such a manner that it acts axially to dampen relative movement between the add-on module 2 and the injection device 1.
[0055]
[0056] In
[0057] As seen in
[0058] On two mutually facing first sides of the essentially square shape of the receiving unit 40, a respective holding element in the form of a holding arm 43.1, 43.2 is arranged, wherein the holding arms 43.1, 43.2 are located in a distal region of the receiving unit 40 with respect to the axial length of the receiving unit 40. The holding arms 43.1, 43.2 are pivotably connected on a first end to the receiving unit 40. In the region of the free end of an outer side of the holding arms 43.1, 43.2 facing away from the internal space, said holding arms each have a cam 44.1, 44.2, each of which can be received in one of the openings 31.1, 31.2 of the housing insert 30. However, in the region of the free end of the holding arms 43.1, 43.2, on an inner side which faces the internal space of the receiving unit 40, the holding arms 43.1, 43.2 each have a projection 45.1, 45.2 (
[0059]
[0060] In the perspective view of
[0061] Alternatively, a switch for detecting the axial position of the receiving unit 40 can be arranged on the receiving unit 40 itself and cooperate with an element secured on the module housing 20 or a projection. In this case, the switch can be fitted on the circuit board 41c (for example manufactured using a so-called flexprint printed circuit) which may be fastened permanently on the outer surface of the receiving unit 40. In an embodiment with a release button 50 which, when the injection device 1 is inserted, is moved with respect to the module housing 20 and/or housing insert 30, this relative movement can also be detected by a switch. In all these cases, a mechanical switch may be used primarily for activating the electronics and additional sensor elements of the electronics unit 60, so that the axial positioning of the switch is not critical and the switch can trigger already before the holding configuration is reached.
[0062] If a switch is arranged on the circuit board 64a, 64b and provided with a suitably extended plunger or completed with a separately spring-mounted adapter, wherein the plunger and adapter preferably pass through the end surface 40b in the longitudinal direction, the presence of the injection device 1 in the holding configuration can also be detected. In this case, sensor elements for the additional identification of the injection device 1 can be omitted.
[0063]
[0064]
[0065] In
[0066] In comparison to
[0067] In a release configuration, the locking cams 42 are located on the distal side of the guiding cams 52. The locking cams 42 each include a contact surface 46 which forms an acute angle with the longitudinal axis of the module housing 20. The guiding cams 52 comprise a respective guide surface 53, each being also oriented at this angle with respect to the longitudinal axis. In the release configuration shown, the guiding cams 52 are in a release position in which the contact surfaces 46 of the locking cams 42 and the guide surfaces 53 of the guiding cams 52 are in contact with one another. The guide surface 53 is pretensioned in the direction of the contact surface 46 by the release button spring 80. In a release configuration in which the receiving unit 40 is located on a distal end of its receiving path, which is determined by the relative arrangement of the flange section 40d and the distal receiving path limit, the guide surface 53 and the contact surface can also be axially separated.
[0068] In order to connect the injection device 1 to the add-on module 2, the latter must be moved from the release configuration into a holding configuration. For this purpose, the receiving unit 40 must be shifted relative to the module housing 20 from a distal into a proximal end position. This shift occurs by means of positioning the injection device 1, the proximal end of which can be inserted into the opening on the distal end of the module housing 20 and moved in the direction of the proximal end of the module housing 20. In the process, the proximal end of the injection device 1 first impacts against the end surface 40b of the receiving unit 40; subsequently the injection device 1 and the receiving unit 40 are shifted against the receiving spring, e.g., damping element 70, in the proximal direction. During this shift, the holding arms 43.1, 43.2 are moved along in the proximal direction, whereby the cams 44.1, 44.2 of the holding arms 43.1, 43.2 slide out of the respective angled openings 31.1, 31.2 in the housing insert 30 and move toward the internal space of the housing or the inserted injection device 1. As a result, the respective projections 45.1, 45.2 on the inner sides of the holding arms 43.1, 43.2 also move toward the injection device 1 and with increasing shifting of the receiving unit 40 in the proximal direction they engage in the recesses 10b in the injection device 1 (
[0069] When the receiving unit 40 is shifted from the distal end position into the proximal end position, the locking cams 42 of the receiving unit 40 cooperate with the guiding cams 52 of the release button 50. Indeed, as soon as the receiving unit 40 has been shifted from its distal end position in the proximal direction, the respective angled contact surfaces 46 of the locking cams 42 of the receiving unit 40 are pressed against the angled guide surfaces 53 of the guiding cams 52 of the release button 50. Since the release button 50 cannot move in the axial direction but is instead movably mounted in the radial direction against the securing direction, the guiding cams 52 shift due to the pressure of the locking cams 42 against the pretensioning force of the release button spring 80 in the radial direction until the locking cams 42 slide beyond the guide surfaces 53 and thereby release the guiding cams 52. At this time, the release button 50 springs back in the securing direction due to the spring force of the release button spring 80. The locking cams 42 are then located on the proximal side of the guiding cams 52. The guiding cams 52 in this position are in their holding position in which they prevent the locking cams 42 from moving in the distal direction, by means of their locking surface 54 oriented at a right angle with respect to the longitudinal position. In this position, the receiving unit 40 is located on a proximal end of its receiving path, and the add-on module 2 is in the holding configuration.
[0070]
[0071]
[0072] In order to separate the injection device 1 from the add-on module 2, the add-on module 2 must be moved from the holding configuration into the release configuration. This is achieved by pressing the actuation surface 51 of the release button 50 so that the release button is shifted along its securing path in the radial direction toward the module housing 20. Thereby, the release button spring 80 is compressed, and the guiding cams 52 are shifted from their holding position into a release position, whereby the locking cams 42 of the receiving unit 40 can be released and moved in the distal direction.
[0073] By manual pressing of the release button 50 against the securing direction and transversely to the longitudinal direction, a short but nonetheless easily recognizable release or ejection movement of the receiving unit 40 in the distal direction of the receiving path is started, at the end of which the add-on module 2 is in the release configuration, and the removal of the injection device 1 from the add-on module can occur. The ejection movement of the receiving unit 40 can here occur exclusively due to the directly exerted force of the user, for example, by a careful deflection of the force transversely to the longitudinal direction via a cam control or a wedge into a force in the direction of the receiving pass, or by pressing an alternative release button or manual shifting of the receiving unit 40 in the longitudinal direction. However, the ejection movement can also occur completely automatically and be driven and assisted by a preloaded energy source, so that the release button is used exclusively as trigger and can thus also be implemented as an electronic contact sensor. Preloaded energy sources are maximally loaded when the add-on module is delivered and they release a smaller amount of energy with each ejection. In addition to a preloaded mechanical energy storage in the form of a spring or a pressurized gas reservoir, an electrical drive is also conceivable.
[0074] The release or ejection movement can also be assisted by the release of energy from a rechargeable energy source as release assistance, which is loaded into the add-on module at the time of the axial insertion of the injection device into the add-on module. For this purpose, a separate spring element, a compressible gas volume, or the receiving spring in the form of an elastic damping element 70 can be provided. At the time of the injection, the spring element compressed in the holding configuration can be relaxed and it can press against the end surface 40b, whereby the receiving unit 40 is shifted in the distal direction. However, the loading or tensioning of the release assistance can also occur only when the ejection occurs by initial pressing of the release button 50 via a first partial stroke, wherein a subsequent final movement of the release button via a second partial stroke serves as trigger for the assistance.
[0075]
[0076]
[0077] Due to the movement of the receiving unit 40 in the distal direction, the holding arms 43.1, 43.2 are also shifted in the distal direction, and the cams 44.1, 44.2 of the holding arms 43.1, 43.2 run along the inner wall of the housing insert 30 and into the openings 31.1, 31.2 due to their shape, e.g., angle, and are force-guided by the openings 31.1, 31.2. The holding arms 43.1, 43.2 are moved outward at an angle away from the internal space of the receiving unit 40, e.g., radially away, whereby the projections 45.1, 45.2 (see, e.g.,
LIST OF REFERENCE NUMERALS
[0078] 1 Injection device [0079] 10 Device housing [0080] 10a Window [0081] 10b Recess [0082] 11 Needle protection sleeve [0083] 12 Needle protection cap remover [0084] 2 Add-on module [0085] 20 Module housing [0086] 20a Gripping region [0087] 20b Link [0088] 20c Stop ridge [0089] 20d Longitudinal opening [0090] 21a, 21b Housing halves [0091] 22 Housing closure [0092] 23 Radial opening [0093] 24 Stop surface [0094] 30 Housing insert [0095] 31.1, 31.2 Opening [0096] 32.1, 32.2 Guide grooves [0097] 33 Perforation [0098] 40 Receiving unit [0099] 40a Indicator edge [0100] 40b End surface [0101] 40c Convexity [0102] 40d Flange section [0103] 40e Arm [0104] 40f Pin [0105] 41a, 41b Sensor coils [0106] 41c Circuit board [0107] 41d Connection [0108] 41e Switch [0109] 42 Locking cam [0110] 43.1, 43.2 Holding arm [0111] 44.1, 44.2 Cam [0112] 45.1, 45.2 Projection [0113] 46 Contact surface [0114] 50 Release button [0115] 51 Actuation surface [0116] 52 Guiding cam [0117] 53 Guide surface [0118] 54 Locking surface [0119] 55a, 55b Spring arm [0120] 56 Clip [0121] 57a, 57b Tensioning arms [0122] 58 Nose [0123] 60 Electronics unit [0124] 61 Electronics holder [0125] 62 Battery [0126] 63 Accumulator/recharchable battery [0127] 64a, 64b Circuit board [0128] 65 Light guide [0129] 66 Antenna [0130] 70 Damping element [0131] 80 Release button spring