MODULAR INJECTION SYSTEM

Abstract

The present disclosure relates to a modular injection system including a first injection device including a first reservoir unit comprising a reservoir filled with medication, a housing for holding the reservoir and a plunger rod adapted to advance a piston inside the reservoir to dispense the medication and first automatic drive unit releasably attachable to the reservoir unit and including an automatic drive member automatically driven by a power source and adapted to be releasably coupled to the plunger rod. The modular system further comprises a second injection device including a second reservoir unit and a manual drive unit connected to the reservoir unit and including a manual drive member manually driven and connected to a plunger rod of the second reservoir unit. The first and second reservoir unit are identical.

Claims

1. A modular injection system, comprising: a first injection device, comprising: a first reservoir unit comprising a reservoir filled with medication, a housing for holding the reservoir and a plunger rod adapted to advance a piston inside the reservoir to dispense the medication; and a first automatic drive unit releasably attachable to the first reservoir unit and comprising an automatic drive member automatically driven by a power source and adapted to be releasably coupled to the plunger rod; and a second injection device, comprising: a second reservoir unit; and a manual drive unit coupled to the second reservoir unit and comprising a manual drive member manually driven and coupled to a plunger rod of the second reservoir unit, wherein the first reservoir unit and the second reservoir unit are identical.

2. The modular injection system according to claim 1, wherein the first injection device further comprises a signaling unit coupled to the first automatic drive unit and comprising a light signaling means for signaling an injection status of the first injection device.

3. The modular injection system according to claim 2, wherein the injection system further comprises a third injection device comprising: a third reservoir unit; a second automatic drive unit; and a display unit coupled to the second automatic drive unit and comprising a display adapted for alphanumerically displaying an injection status of the third injection device, wherein the first reservoir unit and the third reservoir unit are identical, and the first automatic drive unit and the second automatic drive unit are identical.

4. The modular injection system according to claim 3, wherein the first injection device comprises a dose setting member coupled to the first automatic drive unit for manually setting or correcting a dose.

5. The modular injection system according to claim 1, wherein the first injection device comprises an interface member adapted to be coupled to the housing and comprising a plunger rod driver adapted to be coupled to the plunger rod of the first injection device, wherein the plunger rod driver comprises a coupling element adapted to releasably couple the plunger rod driver to the automatic drive member.

6. The modular injection system according to claim 1, wherein the manual drive unit further comprises a dose setting member, a housing, and a retaining member with an engaging element, wherein during dose setting, the manual drive member can be moved in a longitudinal direction relative to the manual drive unit housing, and the manual drive member can be held by the engaging element in a rotationally fixed manner relative to the housing, and wherein during dose dispensing, the manual drive member is released from the engaging element and can rotate relative to the housing.

7. The modular injection system according to claim 1, wherein the automatic drive member comprises an electric motor, and wherein the first automatic drive unit further comprises a controller and a communication module, wherein the controller is adapted to control the electric motor based on injection information received via the communication module.

8. The modular injection system according to claim 1, wherein the first automatic drive unit further comprises injection status sensing means for monitoring an injection status, and storage means for storing acquired injection status information.

9. The modular injection system according to claim 8, wherein at least the first reservoir unit or the second reservoir unit comprises a machine-readable tag with identification information on the medication inside the reservoir or uniquely identifying the reservoir unit, and wherein the first automatic drive unit comprises a tag reader adapted to read the identification information of the machine-readable tag.

10. The modular injection system according to claim 9, wherein based on the identification information of the machine-readable tag, the first automatic drive unit is adapted to control an electric motor of the automatic drive member or to output a notification to a user.

11. The modular injection system according to claim 9, wherein the first automatic drive unit is adapted to determine an amount of dispensed medication or an amount of the medication remaining inside the reservoir based on the acquired injection status information, and is adapted to assign the amount to the read identification information of the corresponding reservoir unit.

12. The modular injection system according to claim 11, wherein the first automatic drive unit is adapted to signal that the amount of dispensed medication or the amount of medication remaining inside the first reservoir exceeds a predefined threshold.

13. The modular injection system according to claim 9, wherein the first automatic drive unit comprises a unique identifier, and wherein the first automatic drive unit is adapted to transmit an identifier set comprising the unique identifier and the identification information to a database.

14. A method for preparing an injection device for an injection, comprising the steps of: a) providing a reservoir unit comprising a plunger rod, a reservoir containing medication and an automatic drive member for automatically driving the plunger rod for dispensing the medication; b) reading an identification information from a machine-readable tag of the reservoir unit or of the reservoir by a tag-reader inside the injection device; c) advancing the plunger rod, by the automatic drive member, towards a piston inside the reservoir until the plunger rod abuts the piston, wherein the drive member is controlled based on the read identification information; and d) carrying out a priming operation.

15. A modular, semi-disposable injection system, comprising: a first injection device, comprising: a first dispensing unit comprising a reservoir filled with medication, a housing for holding the reservoir, a plunger rod adapted to advance a piston inside the reservoir to dispense the medication, an interface member connected to the housing, and a plunger rod driver coupled to the plunger rod; a first automatic drive unit releasably attachable to the first dispensing unit and comprising an automatic drive member adapted to be automatically driven by a power source and adapted to be releasably coupled to the plunger rod driver; and a display unit connected to the first automatic drive unit and comprising a display adapted to alphanumerically display injection information of the first injection device; and a second injection device, comprising: a second dispensing unit; a second automatic drive unit; and a signaling unit coupled to the second automatic drive unit and comprising a light signaling means for signaling injection information of the second injection device, wherein the first dispensing unit and the second dispensing unit are identical, and the first automatic drive unit and the second automatic drive unit are identical.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0158] The subject matter of the disclosure will be explained in more detail in the following text with reference to preferred exemplary embodiments which are illustrated in the attached drawings, in which:

[0159] FIG. 1a-c depict an overview of the modular injection system with three different types of injection pen according to the disclosure;

[0160] FIG. 2a-c depict the three injection pens of FIG. 1 in a sectional view;

[0161] FIG. 3 depicts an exploded view of a semi-disposable injection pen with LCD;

[0162] FIG. 4 depicts a sectional view of the semi-disposable injection pen with LCD;

[0163] FIG. 5a depicts a sectional view of the dispensing unit;

[0164] FIG. 5b depicts a perspective view of the dispensing unit;

[0165] FIG. 6a-c depict the drive unit in a perspective view and in a sectional view;

[0166] FIG. 7 depicts a sectional view of the semi-disposable pen with LEDs;

[0167] FIG. 8a depicts an exploded view of a fully disposable injection pen;

[0168] FIGS. 8b and 8c depict a detail view of the retaining member and the dose sleeve;

[0169] FIG. 9a depicts a sectional view of the fully disposable pen in an initial state;

[0170] FIG. 9b depicts a sectional view of the pen of FIG. 9a in a state with a set dose;

[0171] FIG. 10 depicts a sectional view of a semi-disposable pen with a pen cap with a battery;

[0172] FIG. 11 depicts an overview relating the connectivity;

[0173] FIGS. 12a, 12b, and 12c depict an example of a flow diagram of the functions of the semi-disposable injection pens.

[0174] The reference symbols used in the drawings, and their primary meanings, are listed in summary form in the list of designations. In principle, identical parts are provided with the same reference symbols in the figures.

DETAILED DESCRIPTION

[0175] FIG. 1 depicts an overview of a modular injection system or an injection device family according to the disclosure. The injection devices of the modular system are realized in form of injection pens. The system includes a semi-disposable injection pen 1 with a LC-display (LCD), a semi-disposable injection pen 2 with LEDs and a fully disposable injection pen 3 intended for single use. The modular system thus includes three different types of injection pens, two different semi-disposable pens 1, 2 and one fully disposable pen 3.

[0176] In the present description the term “distal” refers to the side where the needle is attached. This is on the left hand side in the figures. The term “proximal” refers to the opposite side and is on the right hand side in the figures.

[0177] FIGS. 2a to 2c depict each a sectional view of the three types of injection pens 1, 2, 3 wherein the cut runs along a longitudinal axis of the injection pens.

[0178] The injection pen 1 with the LCD depicted in FIGS. 1a and 2a includes a disposable assembly and a reusable assembly. The disposable assembly is formed by a dispensing unit 90 including a reservoir unit 40 and an interface member 70. The reusable assembly includes a drive unit 50 and a LCD unit 60. The reusable assembly is releasably attachable to the disposable assembly.

[0179] The injection pen 2 with LEDs depicted in FIGS. 1b and 2b includes also a disposable assembly and a reusable assembly. As injection pen 1 the injection pen 2 with LEDs includes a disposable dispensing unit 90 including a reservoir unit 40 and an interface member 70. The reusable assembly includes a drive unit 50 and a signaling unit 80 with LEDs. Similar to injection pen 1 the reusable assembly of the injection pen with the LED is releasably attachable to the disposable assembly.

[0180] The fully disposable injection pen 3 depicted in FIGS. 1c and 2c includes a reservoir unit 40 and a manual drive unit 100 non-releasably connected to the reservoir unit 40.

[0181] The injection pens 1, 2, 3 include sub-assemblies and components that are present in all three or in two pens. That means the pens have some sub-assemblies or components in common. Namely, the three different types of injection pen 1, 2, 3 include each an identical reservoir unit 40. The two semi-disposable pens 1, 2 (pen with LCD and pen with LED) additionally include an identical drive unit 50 but they have different display means mounted onto the drive unit 50. The semi-disposable pen 1 and 2 include an identical pen cap 7.

[0182] In the following the three different pens 1, 2, 3 are descripted in detail. Firstly, the structural features of the injection pens are explained. Secondly, the use of the pens, in particular the connectivity with an external cloud server is described.

[0183] The components of the semi-disposable pen 1 with LCD are descripted with respect to FIG. 3 which depicts an exploded view of the semi-disposable pen 1 also shown in FIGS. 1a and 2a. FIG. 4 depicts a sectional view of the same pen 1.

[0184] As mentioned above the disposable dispensing unit 90 includes the reservoir unit 40 and an interface member 70. The dispensing unit 90 is also depicted separately in FIGS. 5a and 5b.

[0185] As shown in the exploded view of FIG. 3 the reservoir unit 40 includes a reservoir holder 10 (or cartridge holder), a reservoir in form of a cartridge 5 containing medication, a mechanics holder 30 and a plunger rod 20 with a flange 21 pivotally mounted on a distal end of the plunger rod 20. The plunger rod 20 includes a thread along its longitudinal shaft. A nut extending along the shaft is adapted to be in engagement with a drive member.

[0186] A thread 31 integrally formed in the mechanics holder 30 holds the plunger rod 20 in threaded engagement with the mechanics holder 30. In an assembled state the flange 21 of the plunger rod 20 abuts a piston 6 (see FIG. 4) inside the cartridge 5. The mechanics holder 30 is sleeve-shaped and includes an end wall or flange on its distal side. The end wall has a centered opening including the thread 31 is located. On the distal side of the end wall the mechanics holder 30 includes two half ring-shaped elements 32a, 32b that are connected to the end wall. The ring-shaped elements 32a, 32b are elastically deformed if a reservoir 5 is hold in the reservoir holder 10. Therefore, the ring-shaped elements bias the cartridge 5 in a distal direction and hold the cartridge 5 non-movable inside the reservoir holder 10.

[0187] The reservoir holder 10 includes at its distal end a thread for mounting a needle assembly (not shown). On its proximal end the holder 10 has snap lock elements for connecting the holder to the interface member 70.

[0188] The dispensing unit 90 includes further the sleeve-shaped interface member 70 enclosing the mechanics holder 30 and the plunger rod 20. An interface member housing 72 is non-dissociable or non-releasably connected to the reservoir holder 10 by a snap lock. The reservoir holder 10 is thus fixed relative to the interface member and encloses and holds the cartridge 5 non-movable between an inner distal end of the reservoir holder 10 and the distal end wall of the mechanics holder 30. The interface member 70 includes the housing 72 and a plunger rod driver 71 coaxially arranged and guided inside the housing 72. The plunger rod driver 71 is splined to the plunger rod 20 such that it is rotationally fixed but axially movable relative to the plunger rod 20. At the proximal end the plunger rod driver 71 includes circumferentially arranged teeth 73 adapted to be rotationally coupled to a drive member 52 of the automatic drive unit 50 in the reusable assembly.

[0189] The interface member 70 includes on its outer surface or integrally formed a machine-readable tag 76 in form of a NFC tag that is readable by a tag reader of the drive unit 50 if the drive unit 50 is attached to the dispensing unit 90. In the embodiment shown in FIG. 3 the tag 76 is arranged on a label 75. Alternatively, the tag 76 can also be placed onto a surface of the cartridge 5. In an alternative embodiment the tag can be a bar code, a QR code or a color code. The tag includes the following information of UDI code, medication type and name, expiry date and volume of the cartridge 5. Furthermore, a needle unit (not shown) mounted to the reservoir holder 10 includes also a tag with a unique identifier allowing the controller to identify the (mounted) needle unit.

[0190] The disposable dispensing unit 90, as shown in FIGS. 5a und 5b can be produced, pre-assembled and stored separately from the reusable assembly. That is, the reservoir unit 40 and the interface member 70 may be produced by a device manufacturer and delivered to the medication manufacturer. The latter inserts the filled cartridge 5 in the reservoir holder 10 and pre-assembles the single components to a sub-assembly, namely to the dispensing unit 90. The cartridge 5 is non-movably hold inside the holder. If the dispensing unit 90 attached to the reusable assembly (drive unit 50 and display unit 60) the plunger rod 20 can be moved towards the piston to prepare the dispensing unit 90 for the first injection. Alternatively, the plunger rod 20 positioned next to the piston at the time of assembly and thus a so-called factory priming can be provided.

[0191] The reusable assembly of the injection device 1 includes the automatic drive unit 50 and the display unit 60. The automatic drive unit 50 (separately depicted in FIGS. 6a, 6b and 6c) includes a support structure 51a, 51b, an electric motor 53 with a motor shaft 58 (FIG. 4), in particular a BLDC motor o stepper motor, for moving the plunger rod 20, a sleeve-shaped automatic drive member 52, a gear connecting the motor shaft 58 and the automatic drive member 52, a printed circuit board (PCB) 55 with a controller (not shown) for controlling the electric motor, an energy source in form of a rechargeable battery 54a, 54b, a tag reader (not shown), a data storage module 57, a communication module 56 and sensing means in form of an encoder (not shown) for sensing the movement of the motor shaft 58 and thus the movement of the plunger rod 20.

[0192] As shown in FIG. 6c depicting the automatic drive unit 50 the motor 53 is arranged in a proximal end portion of the automatic drive unit 50. The PCB 55 with the controller is attached to an outside of the support structure 51a and the rechargeable battery 54a,b of the embodiment shown in FIG. 3 includes two battery packs located on two opposite sides of the support structure 51a. The motor shaft 58 is coupled to the automatic drive member 52 by the gear. The sleeve-shaped drive member 52 includes distally and circumferentially arranged teeth 59 (FIG. 6c) adapted to be coupled to the proximal teeth 73 of the plunger rod driver 71 if the reusable assembly is attached to the dispensing unit 90.

[0193] The communication module 56 is adapted to transmit data between the drive unit 50 and an external device such as a cloud server or a user device in form of a computer, a smart phone, a tablet computer, a smart watch, smart glasses or the like. That means the communication module 56 can receive or send data generated and/or stored in the storage module 57. The communication module 56 is connected to the external device wirelessly, for example, by a wireless local area network (WLAN) or by another short or near range wireless communication technology such as Bluetooth, ZigBee, WiMAX or NFC. In an alternative embodiment the communication module includes a cellular network module such as GSM, LTE or NR for direct and independent internet access.

[0194] The tag reader can read the tag of the dispensing unit 90 if the latter is attached to the reusable assembly. Depending on the embodiment the tag reader is adapted to read the NFC tag, the bar code, the QR code, OID or the color code of the dispensing unit. The read tag information (parameter) are subsequently processed by the controller.

[0195] Furthermore, the drive unit 50 includes itself a tag (not shown) including a unique identifier that can be read, for example, by an add-on device releasably attachable to the injection pen 1.

[0196] The automatic drive unit 50 is coaxially enclosed by the sleeve-shaped display unit 60 and non-dissociable or non-releasably connected thereto. The display unit 60 includes a distal and proximal housing 61, 62, a LCD 65, a spring 63 and a dose knob 64. The latter is arranged on a proximal end of the proximal housing 62 and can be used by a user to manually set a dose by rotating the dose knob 64. The dose knob 64 is further axially moveable to the housing and biased in a proximal direction by the spring 63 arranged inside the dose knob. The LCD 65 can display a set or dispensed dose, an injection status, a battery status, instructions for use (IFU) or information read from the tag of the dispensing unit 90 or information received from an external device via communication unit. The LCD 65 is hence electrically connected to the PCB 55 of the drive unit 50. On an inside and distal end portion of the sleeve-shaped distal housing 61 a L-shaped nut is arranged (not shown) forming part of a bayonet connection between the dispensing unit 90 and the display unit 60.

[0197] FIG. 4 depicts a sectional view of the semi-disposable injection pen 1. As shown in FIG. 4 the dispensing unit 90 is attached to the automatic drive unit 50 and the display unit 60. In other words the disposable assembly is attached to the reusable assembly forming the injection pen 1. To mechanically attach the disposable dispensing unit 90 to the reusable assembly (dose unit 50 and display unit 60) the proximal cylindrical portion of the interface member 70 is inserted into the sleeve-shaped distal display unit housing 61. During insertion the proximal teeth 73 of the plunger rod driver 71 get into contact with the distal teeth 59 of the automatic drive member 52 and thereby rotationally coupling the plunger rod driver 71 to the drive member 52. Furthermore, a protrusion 74 (FIG. 5b) located on an outside of the interface member housing 72 is inserted in the L-shaped nut of the display unit housing 61. With a rotational movement of the dispensing unit 90 relative to the drive unit 50 and display unit 60 the dispensing unit is mechanically connected to the display unit 60 and the drive unit 50 by the bayonet connection.

[0198] A dose is set either manually by the user or automatically by instructions of a therapy plan or based on instruction of the medication manufacturer via cloud server or by information read from the tag of the dispensing unit. To manually set a dose the user rotates the dose knob 64. To correct a dose the dose knob 64 can be rotated in a counter direction. The set dose is displayed on the LCD 64 and additionally on the user device as the controller transmit the data via communication module 56 to the user device. Additionally, the controller logs the set and dispensed doses and transmits a log entry to the cloud server.

[0199] In normal operation the dose is set automatically. The controller periodically request injection information form the cloud server via user device. At least if the user replaces the dispensing unit and attaches a new dispensing unit to the reusable assembly the controller request the injection information. These information contain the time and the amount of the dose of the next upcoming injection. After receiving the information via user device the controller sets the dose and displays it on the LCD. The dose is additionally displayed on the user device.

[0200] For both cases, for the manual setting and for the automatic setting the user only has to initiate the injection process by pushing the dose knob 64.

[0201] An example of a use case is descripted with respect to the FIGS. 11, 12a and 12b further below.

[0202] FIG. 7 depicts the semi-disposable injection pen 2 with LEDs. As mentioned above the pen 2 has an identical dispensing unit 90 and an identical drive unit 50 as the injection pen 1 with the LCD.

[0203] However, the dose unit 50 of the injection pen 2 is connected to a signaling unit 80 instead of a display unit. In contrast to the display unit 60 the signaling unit 80 is devoid of any display or screen and includes only three LEDs 85a, 85b, 85c indicating the injection status, the battery status and the connection (Bluetooth) status. The three LEDs 85a, 85b, 85c are depicted in FIG. 1b. There is a light path or a light guide (shown in FIG. 7) for each LED 85a, 85b, 85c to guide the light from the PCB 55 to an outer surface of a proximal housing 82.

[0204] A further difference is that the injection pen 2 does not include a rotatable dose knob. As depicted in FIG. 7 the signaling unit 80 has a dispensing button 84 that can be pushed in the longitudinal direction by the user to initiate or start an injection. The signaling unit 80 is hence less complex and can be manufactured on lower cost compared to the display unit 60.

[0205] All other features of the injection pen 2, in particular the bayonet connection and the coupling between the automatic drive member 52 and the plunger rod driver 71 are identical to the injection pen 1 with LCD.

[0206] The upcoming injection or injection information are signaled to the user by the LEDs. A green LED is activated to signal that the dose is ready for injection. The value of the dose is displayed on the user device. LEDs of other colors (orange, red) signal the user an error condition, an expired used-by date or that a wrong dispensing unit is attached to the reusable assembly. The codes of the colors are displayed on the user device.

[0207] The fully disposable injection pen 3 according to the disclosure is depicted as an exploded view in FIG. 8a. FIGS. 9a and 9b depicts a sectional view of the disposable pen 3. In the following the structural features are descripted in detail with respect to FIGS. 8 and 9. Subsequently, the function and in particular the setting and correction of a dose are descripted.

[0208] The fully disposable injection pen 3 includes the removable cap 7 and the reservoir unit 40 which is identical to the reservoir unit 40 of the semi-disposable injection pens 1, 2. The disposable injection pen 3 further includes a manual drive unit 100.

[0209] As mentioned above the reservoir unit 40 includes the reservoir holder 10, the cartridge 5, the plunger rod 20 with flange 21 and the mechanics holder 30. The manual drive unit 100 includes a housing 180, dose sleeve 110 for setting a dose, a dose insert 120, a retaining member 130, a manual drive member or drive sleeve 150, a stop nut 140, a click sleeve 160 and a dispensing button 170.

[0210] FIG. 8c depicts a detailed view of the dose sleeve 110. The dose sleeve 110 has the form of a hollow cylinder or sleeve and has on its proximal end a larger diameter forming a grip portion 111. On an outer surface of a distal portion are helically arranged numbers that are visible through an opening (dose window) in the housing 180 during dose setting and dispensing. In a distal portion the dose sleeve 110 includes an inner dose insert 120 coaxially arranged inside the dose sleeve 110 and having a smaller diameter than the dose sleeve 110. The dose insert 120 is rotationally and axially fixed to the dose sleeve 110 or in an alternative embodiment integrally formed with the dose sleeve (in one piece as two component part). Between an inner surface of the dose sleeve 110 and an outer surface of the dose insert 120 a cylindrical gap is formed. In this gap the mechanics holder 30 fixed to a housing 180 is accommodated.

[0211] On an outer surface the dose insert 120 has a thread adapted to engage a radially inward protruding thread element 33 (see FIG. 9a) of the mechanics holder 30. The dose insert 120 and the dose sleeve 110 are therefore in threaded engagement with the mechanics holder 30.

[0212] On a distal end the dose insert 120 includes a circumferential nut 121 (FIG. 8a). The retaining member 130 includes a corresponding hook element 131 adapted to engage the nut 121. The retaining member 120 is therefore axially coupled but rotationally free relative to the dose insert 120 and the dose sleeve 110. Furthermore, the hook element 131 guides the retaining member in a groove on an inside of the mechanics holder 30 such that the retaining member is rotationally fixed relative to the mechanics holder but axially moveable thereto.

[0213] The dose insert 120 has further a stop element in form of a ramp arranged on an outer distal end portion. The stop element abuts a counter ramp element of the mechanics holder 30 in an initial or retracted positon of the dose insert 120. The ramp elements form thus a first or minimal stop for the dose sleeve. The dose sleeve 110 has on its inside a radially protruding stop element (not shown) adapted to engage a counter stop element on an outer surface of the mechanics holder 30 (not shown). The stop element abuts the counter stop element if the dose sleeve 110 is screwed out to an end position.

[0214] In a proximal portion the dose sleeve 110 includes on its inside axially extending nuts 112 (FIG. 9a) in which the stop nut 140 is in splined engagement and is axially guided. Proximal to the nuts 112 the dose sleeve 110 has a larger inner diameter. Thus an inner radial wall is present between the nuts 112 and the portion with the larger diameter. On this inner wall are saw teeth 113 (FIG. 8c) circumferentially arranged and adapted to engage counter saw teeth 161 of the click sleeve 160 as descripted below. At the proximal end the dose sleeve 110 has on its inside circumferentially arranged radial nuts 114 adapted to accommodate radial 155 teeth of the drive member.

[0215] FIG. 8b depicts a detailed view of the retaining member 130. It is sleeve-shaped and is axially fixed to the dose sleeve 110 by its hook element 131 as descripted above. The retaining member 130 is splined to the mechanics holder 30 and thus rotationally fixed thereto but axially moveable relative to the mechanics holder 30 (and thus to the housing 180). On an inside the retaining member 130 has nuts 132.

[0216] The sleeve-shaped manual drive member 150 includes on its distal end a portion with a smaller outer diameter. In this portion are circumferentially arranged protrusions 151 adapted to be engaged with the corresponding nuts 132 of the retaining member 130. A proximal portion of the end portion (axially in-between teeth and larger diameter of drive member) is smaller than the most inner diameter of the retaining member 130 such that the retaining member 130 is not engaged with the drive member 150 if it is axially positioned at this distal end portion, e. g. if the drive member 150 is in a released position during dose dispensing (explained below).

[0217] On a proximal portion the drive member 150 includes an outer thread 154 for the stop nut 140. Proximal the outer thread 154 of the drive member includes a cylindrical portion for guiding the click sleeve 160. The cylindrical portion ends on a proximal end with a flange 152 forming a proximal end of the drive member 150. On a distal directed side of the flange 152 are saw teeth 153 circumferentially arranged and adapted to engage corresponding saw teeth on the clicker sleeve 160. On its outer circumference the flange 152 has radial teeth 155 protruding radially outward and adapted to engage in the radial nuts 114 inside the dose sleeve 110.

[0218] The drive member 150 has an opening or blind bore in the longitudinal direction from the proximal end. In this bore the dispensing button 170 is guided.

[0219] From a distal end the drive member 150 has also a blind bore in the longitudinal direction with an inner axial spline adapted to rotationally couple the drive member 150 to the plunger rod 20 but allowing the drive member 150 to be axially shifted relative to the plunger rod 20.

[0220] The click sleeve 160 is coaxially positioned around the cylindrical portion of the drive member 150. The click sleeve 160 includes slits or recesses in its cylindrical body allowing the click sleeve 160 to be elastically deformed in a longitudinal direction. On the click sleeve distal front and on the proximal front circumferentially arranged saw teeth are present. Distal teeth 161 are adapted to ride over or engage counter saw teeth 113 on the dose sleeve 110 and proximal saw teeth (not shown) are adapted to ride over or engage counter saw teeth 153 of the flange 152 of the drive member 150. The click sleeve 160 is slightly compressed and axially sandwiched between the radial wall of the dose sleeve 110 and the flange 152 of the drive member 150. As the click sleeve 160 is elastically compressed it biases the drive member 150 in a proximal direction. An axial movement of the drive member 150 is limited by the nuts 132 of the retaining member 130.

[0221] The dispensing button 170 is t-shaped with a shaft and a flange and is hold and guided by the blind bore of the drive member 150. The shaft has a circumferentially extending rib 171 and the drive member blind hole has a corresponding nut accommodating the rib 171. The dispensing button 170 is thus axially fixed but rotationally free relative to the drive member 150.

[0222] The stop nut 140 is ring-shaped and includes on its inner diameter a thread element adapted to engage the outer thread 154 of the drive member 150. On its outer surface the stop nut 140 includes protrusions engaging the longitudinal nuts 112 of the dose sleeve 110 which rotationally couple the stop nut 140 to the dose sleeve 110. On its proximal end the stop nut 140 includes stop elements that abut corresponding stop elements of the drive member 150 if the stop nut is in an end position.

[0223] The described parts of the injection pen 1 are made of plastic as known in the art, for example, polypropylene (PP). The click sleeve 160 can be made of metal or made of plastic.

[0224] FIG. 9a depicts the fully disposable pen 3 in a start or initial position. To set a dose the user grabs the grip portion 111 and rotates the dose sleeve 110. As the dose sleeve 110 is in threaded engagement with the mechanics holder 30 the dose sleeve 110 is screwed out of the housing 180.

[0225] The plunger rod 20 and the drive member 150 rotationally coupled to the plunger rod 20 are not rotated due to the rotational coupling to the retaining member 130. The click sleeve 160 does not rotate either as the steep flank of its proximal saw teeth abut the steep flank of the saw teeth 153 of the drive member 150. As the click sleeve 160 abuts the radial wall inside the dose sleeve 110 both, the click sleeve and the drive member are shifted proximally when the dose sleeve 110 is screwed out of the housing 180.

[0226] During dose setting the dose sleeve 110 is rotated relative to the click sleeve 160. Due to the axially and elastically deformable click sleeve 160 the saw teeth of the dose sleeve 110 are able to ride over the distal saw teeth 161 of the click sleeve 160 providing audible and tactile feedback to the user during dose setting.

[0227] As the retaining member 130 is axially connected to the dose insert 120 by its hook element 131 the retaining member 130 is axially moved together with the drive member 150. However, the retaining member 130 cannot rotate during this movement as it is splined to the mechanics holder 30.

[0228] FIG. 9b depicts the disposable injection pen 3 in a state with a set dose. As shown in FIG. 9b the dose sleeve 110, the dose insert 120, the retaining member 130, the click ring 160 and the manual drive member 150 with the dose button 170 are moved in proximal direction relative to the housing 180.

[0229] If the user unintentionally sets a dose too large the dose can be corrected by screwing the dose sleeve 110 back into the housing 180. During this reverse rotation the steep flanks of the saw teeth 113 of the dose sleeve 110 abut the steep flanks of the distal saw teeth 161 of the click sleeve 160 and thus rotating the click sleeve 160 together with the dose sleeve 110. As the drive member 150 still does not rotate the proximal saw teeth of the click sleeve 160 ride over the saw teeth 153 of the drive member flange 152 and provide audible and tactile feedback to the user.

[0230] During dose setting and dose correction the stop nut 140 is rotated with the dose sleeve as rotationally splined thereto. The stop nut thus moves up or down the thread 154 of the drive member 150, respectively.

[0231] As the click sleeve 160 is axially compressed it biases the drive member 150 in proximal direction. That ensures that the distal and proximal saw teeth of the click sleeve 160 are held in engagement or pressed to the saw teeth 113 of the dose sleeve 110 and the saw teeth 153 of the drive member 150.

[0232] To dispense a set dose the user pushes the dispensing button 170 in distal direction. As the dispensing button is supported by a central arranged pin inside the drive member 140 any distal movement of the dispensing button 170 is transferred to the drive member 150 and thus it is shifted in the distal direction too.

[0233] The shifting of the drive member 150 in distal direction has two effects. Firstly, the click sleeve 160 is further compressed and therefore the radial teeth 155 of the drive member 150 can engage the radial nuts 112 in the dose sleeve 110 thereby rotationally coupling the drive member 150 to the dose sleeve. Secondly, if the drive member 150 is further shifted in distal direction the distal protrusion 151 are moved out of engagement with the nuts 132 and therefore the rotational coupling between the drive member 150 and the retaining member 130 (and the housing) is released.

[0234] If the dispensing button is further pushed the dose sleeve 110 starts to rotate back into the housing 180 due to its threaded engagement. The drive member 150 is now rotationally coupled to the dose sleeve 110 and rotates too. As the drive member 150 is in splined engagement with the plunger rod 20 the latter is rotated as well. As the plunger rod 20 is threaded engagement with the mechanics holder thread 31 it is screwed in distal direction. By this distal movement the flange 21 of the plunger rod 20 shifts the piston 6 inside the cartridge 5 in distal direction and thereby causing the medication to be dispensed out of the cartridge 5.

[0235] The retaining member 130 is moved distally too (as axially coupled to the dose insert) but does not rotate because it is rotationally fixed relative to the mechanics holder 30 (and the housing). As the drive member 150 keeps its shifted distance relative to the retaining member the protrusions 151 cannot engage the nuts 132 again meaning that the drive member stays rotationally free during dispensing.

[0236] As mentioned drive member 150 and the dose sleeve 110 are rotationally coupled and thus there is no relative movement therebetween. The stop nut 140 is thus not moved during dose dispensing.

[0237] FIG. 10 shows a sectional view of a further embodiment of the above descripted semi-disposable injection pen 1. The injection pen 201 depicted in FIG. 10 includes a different pen cap 202 and a different display unit than the injection pen 1 descripted above. Namely, the pen cap 202 includes a battery 203 which is electrically connected by a wire 204 inside the cap 202 to a proximal connection element 205.

[0238] If the pen cap 203 is attached to the dispensing unit 90 and display unit 260 the connection element 205 mechanically contacts a counter connection element 206 located on an outer surface of the display unit 260. The connection element 206 is electrically connected to the electric circuit of the drive unit 50. If a cap is mounted onto the display unit 260 an electrical connection between the battery 203 in the cap 202 and the battery 54a, 54b in the drive unit 50 is established. The rechargeable battery 54a, 54b can thus be charged every time the cap 202 is mounted.

[0239] All other components and in particular the dispensing unit 90 and the drive unit 50 of the semi-disposable pen 201 are identical to the components of the injection pen 1. In a further embodiment the cap 202 can also be used with an injection pen 2 with a LEDs. In this case the signaling unit includes an electrical connection element and an electrical connection to the electric circuit of the drive unit as described above.

[0240] In the following section the connectivity and the interaction with the user of the semi-disposable injection pens 1, 2 are descripted in detail with respect to FIGS. 10, 12a and 12b. For the following description the term “semi-disposable injection pen” or “injection pen” is used. The term is to be understood that both types the semi-disposable injection pen with LC-display and the semi-disposable injection pen with LEDs are included.

[0241] FIG. 11 gives an overview of the connectivity and data transfer with the semi-disposable injections pens 1, 2.

[0242] The communication module of the drive unit is wirelessly connected to a user device 503 via Bluetooth or any other short range communication system. The user device 503 is further connected to the internet. The injection pen is previously paired with the user device to allow data transfer.

[0243] As stated above with respect to the semi-disposable pen the user device 503 includes a smart phone, a tablet computer, a smart watch, a desktop computer, smart glasses or AR glasses. An application is installed on the user device (for example an “app” running on the smart phone or smart watch) allowing the user to communicate with the injection pen and additionally with the cloud server 500.

[0244] Alternatively, the communication module can be connected to a WLAN and via router connected to the internet without using a user device. In further embodiment the communication module includes a mobile module (e. g. sim card) and is directly connected to the internet by a mobile network standard or cellular standard such as GSM, LTE, NR with 5G or 6G. In any case a data communication is established between a cloud server 500 which is connected to the internet and the communication module in the injection pen.

[0245] A computer of a healthcare institution 501 (e.g. a healthcare insurance), a computer of a HCP or doctor 502 and a computer of the injection device manufacturer 504 and medication manufacturer 505 is connected to the cloud server 500 by internet as well.

[0246] The healthcare institution 501 receives injection data and logged injection events which have been previously sensed and subsequently transmitted to the cloud server 500 by the communication module. The healthcare institution 501 has also access to and can amend a therapy plan stored on the cloud server.

[0247] In the same manner the HCP or doctor 502 or medication manufacturer 505 can access the logged injection data and the therapy plan on the cloud server 500. Furthermore, the HCP or medication manufacturer 505 can communicate with the user through messages transmitted between the device of the HCP 502 or the manufacturer respectively and the user device 503 via cloud server 500. The HCP can establish, amend or replace the therapy plan on the cloud server 500. Depending on the setting the controller of the drive unit automatically requests the dose information (and parameters) from the therapy plan. The HCP can thus via cloud server 500 control the administration of the medication.

[0248] The user can communicate with the injection pen manufacturer 504 via cloud server 500 in case of a malfunction of the pen or regarding a guarantee claim. The pen manufacturer 504 can send software updates for the drive unit via cloud server 500 and user device 502. Notifications for the user are displayed in this way on the user device 502 and additionally on a display of the injection pen.

[0249] In the following section a use case is described with respect to the flow diagram depicted in FIGS. 12a and 12b.

[0250] In a first step 701 the dispensing unit is assembled at the device manufacturer's site and the tag is mounted either on a surface of the interface member or directly on a surface of the cartridge. At step 702 the information as UDI code, medication type and name, expiry date and the volume of cartridge are written to the tag in an only machine-readable format. A unique identifier of each dispensing unit is stored and registered in a database on the cloud server. The unique identifier is linked to instructions or information.

[0251] If a user connects a new dispensing unit to the reusable assembly (step 703) by the bayonet connection a sensor of the drive unit detects the replacement or the new dispensing unit and awakes the electronic circuit in the drive unit. The controller activates the tag reader which reads the unique identifier and other tag information from the tag in step 704.

[0252] At step 705 the controller of the drive unit processes the read tag information and compares the information with predefined stored information on the cloud server. Optionally, the controller transmits the read unique identifier of the dispensing unit and a unique identifier of the reusable unit together to the cloud server. Accordingly, the set of unique identifiers is stored in a database on the cloud server allowing to record and track the combination of disposable unit and reusable unit used.

[0253] Namely, the controller verifies the read medication data with a predefined medication information stored in the storage unit or alternatively transmits the read information to the cloud server. The latter sends a confirmation if the medication corresponds to the correct medication indicated in the therapy plan. If the medication does not match to the therapy plan or to the value in the storage module of the drive unit the controller does not allow starting an injection and displays or signals a warning to the user via LCD or via red LED and additionally sends a message to the user device.

[0254] Furthermore, at step 706 the controller compares the read expiry data with the current date to verify whether the medication can be used or whether it already expired. In the latter case the controller informs the user accordingly.

[0255] At step 707 the controller communicates via communication module with the cloud server to obtain data of the therapy plan. The server provides the injection information related to the identified medication and the identified user. The controller automatically sets the dose according to the received injection information and subsequently notifies the user about the time and the dose of next upcoming injection.

[0256] Alternatively, the injection information received contain only an injection reminder and the user sets the dose manually either directly with the dose knob on the injection device or with the user device which subsequently transmits the set dose to the drive unit.

[0257] The controller verifies at step 708 the amount of medication remaining in the cartridge. From the read the controller has the information about the cartridge size. From the encoder the controller obtains the information about already dispensed doses. That means each time the plunger rod is moved for dispensing a dispensing movement is sensed. The controller then determines the dispensed dose and stores the dispensed doses in the storage module. Based on the already dispensed doses of a cartridge and based on a total volume of the cartridge the controller is able to calculate the remaining amount of medication inside a specific cartridge.

[0258] The controller allocates all dispensed doses to the corresponding unique identifier and stores the values locally in the storage unit or transmits the values to the cloud server.

[0259] This allows the controller to warn the user if a remaining amount of medication is not enough for an upcoming injection. The controller can inform the user that the upcoming injection has to be split (split dose) and that the user has to keep ready a second dispensing unit for the next injection.

[0260] At step 709 the controller request a needle to be mounted to the reservoir holder. After the user has confirmed it at step 710 the priming process can start.

[0261] At step 711 (FIG. 12b) the controller checks whether the plunger rod has to be moved towards the piston inside the cartridge (new, unused dispensing unit) or the plunger rod is in a position ready to prime (already used dispensing unit).

[0262] In case the dispensing unit has not been replaced since the last injection the controller starts an automatic priming (step 712), e. g. moves the piston inside the cartridge a very small distance to convey fluid through the needle and to avoid any air bubble in the needle or in the cartridge. In case the dispensing unit has been replaced since the last injection the controller has to move the plunger rod relative to the piston and towards the piston, step 711. For that purpose, the controller firstly uses a fast forward movement and secondly if the flange of the plunger rod is close to the piston the controller drives the plunger rod with a reduced speed until the flange abuts the piston of the cartridge (the information about the volume and therefore the distance to move the plunger rod is contained in the information read from the tag). Subsequently, the controller performs the automatic priming and the user has to confirm the successful termination (drops of medication visible) of the priming at step 714.

[0263] Once the priming process is terminated the controller writes a corresponding log in the log book on the cloud server at step 715. Subsequently, the controller sets the planned dose at step 716 or alternatively the user sets the dose according to dose information received from the cloud server (see previous step 707).

[0264] The controller further confirms the user that the planned dose is now ready to be administered (step 717). The user then can start the injection at step 718 by pushing the dispensing button or dose knob, respectively.

[0265] At step 719 (FIG. 12c) the controller controls the drive unit to move the plunger rod in a distal direction to dispense the dose. The encoder in the drive unit measures the movement of the drive member and the controller determines the actually dispensed units based on the measurement. The measured values are stored as a log record in the storage module together with the time and the information about the medication (below step 721). All logged events are also transmitted to the cloud server. The controller updates the stored data about the remaining medication in the cartridge accordingly.

[0266] After the set dose has been injected the controller signals the user to keep the injection pen onto the injection site for a predefined time (holding time) at step 720. For that purpose, the controller decrements a value of the predefined period displayed on the LCD or the controller activates a LED during the holding time. The holding time is additionally displayed on the user device. The holding time depends on the medication. The controller receives the information about a specific holding time when reading the tag of the dispensing unit. Furthermore, the controller monitors (by inertial sensors) that the user keeps holding the injection pen onto the injection site during the holding time. In case the user does not respect the holding time the controller indicates a warning and optionally updates the log entry. Upon expiry of the holding time the controller sends the acquired injection data to the cloud server at step 721.

[0267] At step 722 after the injection has been completed the controller signals the user that the needle has to be discarded. Such information is displayed on the LCD of the display unit or by different LEDs of the signaling unit respectively and on the user device. The user has to confirm the disposal at step 723.

[0268] In case the cartridge is almost empty the controller warns the user or displays a request for replacing the dispensing unit at step 724. As described above the controller informs the user in case the next injection has to be split (split dose). Subsequently, at step 725 the controller signals that the device is ready for the next injection.

[0269] In an alternative embodiment the descripted transmission and storage of data on the cloud server is provided by the storage module or the communication module respectively of the drive unit itself. That means the therapy plan, the predefined doses, injection instruction, user specific alerts and the like are stored in the storage module on the injection device. The controller reads the information from the storage module, for example, if a new dispensing unit is attached to the drive unit. Consequently, there is no need for a data connection to any external device (user device or cloud server) and the above descripted function are still available. That may be advantageous in particular if there is no internet connection available or if injection data are confidential or if injection data are not supposed to be transmitted via data network.

[0270] In a further embodiment the drive unit is directly paired and connected to the cloud server. As mentioned above in connection with FIG. 11 the communication module includes in this case a wireless module adapted to transmit data directly to the cloud server. That means the controller communicates directly with the cloud server and can obtain the injection information and therapy plan directly from the cloud. Thus, there is no need to pair and connect the injection pen to a user device. All function descripted above are maintained by the direct data transfer between the communication module of the drive unit and the cloud server.

[0271] In this case, the doctor, the HCP, the manufacturer of the injection pen or the manufacturer of the medication connects the drive unit to the cloud server before the device is delivered to the user. That is advantageous as the user does not have to pair and connect the drive unit with a local network or with the user device. Additionally or instead the drive unit is paired to the user device at the manufacturer's site if the user data are known at that time.

[0272] In a further embodiment drive unit is paired with a blood sugar measurement (BGM) device or with a continuous blood sugar measurement (CGM) device and is adapted to receive values of these devices. In this embodiment the controller determines the dose to be administered based on received BGM or CBM values. Additionally or instead, the controller can receive the values from the therapy plan or instructions from a HCP stored on the cloud server. If necessary, the user can manually adjust or correct the dose to be administered by the dose knob at the drive unit. This is useful, for example, for a diabetes therapy requiring the user to adjust a set dose of insulin or insulin derivatives depending on the meal or on other circumstances.

[0273] The automatic drive unit 50 and the display unit 60 (injection pen 1) or the drive unit 50 and the signaling unit 80 (injection pen 2) are assembled at the manufacturer's site and cannot be separated by the user of the injection device. However, in a preferred embodiment the drive unit 50 and display unit 60 or the signaling unit 80 are connected to each other by a snap lock, by a thread or by any other form-locked connection which can be released by the manufacturer, by a repair facility or by any trained and authorized technician but not by the user.

[0274] This allows to separate the components or units of the injection device 1, 2 upon the device 1, 2 has reached its end of life or if the device has been returned to the supplier. Some or all components or units of the used injection device 1, 2 may be reused for another injection device in order to reduce waste and energy consumption (circular economy). Accordingly, the used parts or units, in particular the drive unit 50, the display unit 60 or the signaling unit 80 can be used for more than one product cycle.

[0275] While the disclosure has been described in detail in the drawings and foregoing description, such description is to be considered illustrative or exemplary and not restrictive. Variations to the disclosed embodiments can be understood and effected by those skilled in the art and practising the claimed invention, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word “including” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. The mere fact that certain elements or steps are recited in distinct claims does not indicate that a combination of these elements or steps cannot be used to advantage, specifically, in addition to the actual claim dependency, any further meaningful claim combination shall be considered disclosed.

LIST OF DESIGNATIONS

[0276]

TABLE-US-00001  1 Semi-disposable pen with LCD  2 Semi-disposable pen with LEDs  3 Fully disposable pen  5 Cartridge  6 Piston  7 Pen cap  10 Cartridge holder  20 Plunger rod  21 Flange  30 Mechanics holder  31 Thread  32a,b Elastic elements  33 Thread element  40 Reservoir unit  50 Automatic drive unit  51a,b Support structure  51b Support structure  52 Automatic drive member  53 Electric motor  54a,b Battery  55 PCB  56 Communication module  57 Storage module  58 Motor shaft  59 distal teeth  60 Display unit  61 Distal housing  62 Proximal housing  63 Spring  64 Dose knob  65 LCD  70 Interface member  71 Plunger rod driver  72 Housing  73 Teeth  74 Protrusion  75 label with tag  76 tag  80 Signaling unit  81 Distal housing  82 Proximal housing  84 Dispensing button  85a,b,c LEDs  90 Dispensing unit 100 Manual drive unit 110 Dose sleeve 111 Grip portion 112 Nuts 113 Saw teeth 114 Radial nuts 120 Dose insert 121 Nut 130 Retaining member 131 Hook element 132 Nuts 140 Stop nut 150 Manual drive member 151 Protrusion 152 Flange 153 Saw teeth 154 Thread 155 Radial teeth 160 Click sleeve 161 Saw teeth 170 Dispensing button 171 Rib 180 Housing 201 Injection Pen 202 Cap 203 Battery 204 Wire 205 Connection element 206 Connection element 260 Display unit