FIELD OF THE INVENTION

The present invention relates to an injector for subcutaneous injection of a drug into a patient. In particular, it relates to an injector comprising a durable module configured to be engaged with a disposable cartridge holder with a drugcontaining cartridge.

OBJECT OF THE INVENTION

This invention addresses the below listed benefits in relation to creating one injector device carrying different subcutaneous drugs (such as insulin, GLP1, Growth Hormone, etc.) for frequent usage. The benefits may not all be obtained in all embodiments of the invention.

1- Reducing the environmental impact of using disposable devices worldwide by many drug companies. Meaning that they can focus on the drug development, while this proposed delivery system will take care of the injection of any drug type using a drug carrier such as a Cartridge, according to the specific requirements for subcutaneous injection of each drug type.

2- This injector device would ensure safe and effective differentiation for reusable (durable) devices from one drug Cartridge to another, preventing mix-up situations to the same level as for known disposable injector devices.

3- Providing simplicity and ease of use.

4- Clear and visible information will be available even in a dark environment.

5- By introducing electronic technical solutions, fewer mechanical movements will be required, avoiding critical processes and tolerances.

6- All injection data such as drug type, time, date and size of dose will be register and transmitted to an external receiver such as Apps on a mobile phone.

7- All types of injections with both multiple dose sizes, fixed dose size and multi-fixed dose size are handled by the same injection device.

8- There will be no need for flow-check of the needle. 9- Provide an alternative to the prior art.

SUMMARY OF THE INVENTION

Thus, the above-described objects and several other objects are intended to be obtained in a first aspect of the invention by providing an injector for subcutaneous injection of a drug into a patient, the injector comprising:

- a disposable cartridge holder configured to house a drug-containing cartridge,

- a durable module configured to be engaged with the cartridge holder at a first end of the durable module, and

- a durable cap configured to at least partly cover the cartridge holder when it is engaged with the durable module but not in use, wherein the disposable cartridge holder comprises an identifier code, such as a QR code or a bar code, which is unique for the drug in the cartridge housed therein during use, which identifier code comprises information related to the drug and to the intended injection of the drug, and wherein the durable module comprises:

- a longitudinally movable piston rod for applying, during use, a pressure to a movable rubber plunger liquid-sealingly closing an end of the cartridge,

- a motor for moving the piston rod,

- a battery for powering the motor,

- an electronic display, such as an OLED, arranged on an outer surface of the durable module and around a body of the durable module, and

- a scanner configured to read the identifier code when the cartridge holder is engaged with the durable module, and wherein the durable module in response to output from the scanner:

- shows information on the electronic display about the actually present drug, and

- configures the motor to move the piston rod in a predetermined manner matching the actually present drug upon subsequent activation of the motor and thereby perform injection of the drug into the patient. The injector may further comprise an actuator, such as a dome switch, arranged at a second end of the durable module, the actuator being configured to be manually activated resulting in an activation of the motor.

In some embodiments of the invention, the injector further comprises a loudspeaker configured to send out sound resembling recorded sound of a corresponding injector having mechanical means for manually adjusting the setting of the injector.

The injector may further comprise a transmitter and a receiver configured to communicate with an external device, such as for receiving information about the necessary settings of the durable module in dependence of the specific drug in the cartridge holder engaged with the durable module.

In such embodiments, the external device may be a mobile phone, a computer, a local server, a network server, or a cloud server.

In some embodiments of the invention, the cartridge holder further comprises a wake-up indicator configured to send:

- a signal to the durable module upon attachment and detachment of the cartridge holder for recognition of the identifier code, and/or

- a signal of a timing for return of the piston after detachment of cartridge holder.

In some embodiments of the invention, the piston rod is provided with a pressure sensor configured to measure an actual pressure on a piston head facing towards the rubber plunger and to provide an output presenting the pressure to a user of the injector.

In some alternative embodiments to those just mentioned, the injector further comprises a laser-based distance sensor configured to determine an actual position of the rubber plunger.

In some of such embodiments comprising a laser-based distance sensor,

- the piston rod is configured to rotate during its forwards and backwards movement during use of the injector, - the injector further comprises a piston washer rotationally locked to the piston rod and provided with well-defined holes allowing passage of laser light emitted from the laser-based distance sensor and thereby allowing measurement of the positions of both the piston washer and the rubber plunger so that any gap there between can be eliminated before the injection takes place,

- for avoiding unintentional injection during the measurements of the positions, the piston rod is configured to start with a slightly backward rotation before the measurements during use of the injector, and

- the piston rod is configured to move backwards at the end of an injection for confirmation of the completion of the injection by checking with the laser sensor that the rubber plunger does not move any further.

In some embodiments of the invention, the battery is configured to be recharged, such as via a wireless inductive power supply.

BRIEF DESCRIPTION OF THE FIGURES

The injector according to the invention will now be described in more detail with regard to the accompanying figures. The figures show one way of implementing the present invention and is not to be construed as being limiting to other possible embodiments falling within the scope of the attached claim set.

Figure 1 schematically shows the main elements of the Semi-durable Pen injector according to an embodiment of the invention.

Figure 2 schematically shows two possible positions of the QR code and wake-up solutions on the Cartridge-holder of an embodiment of the invention.

Figure 3 schematically illustrates that the same Durable module will be able to display different type of brands once the drug type code is identified.

Figure 4 schematically illustrates some of the visible elements of the semi Durable Device according to an embodiment of the invention. Figure 5 schematically shows possible positions of main elements of the semi Durable Pen injector, when using a pressure sensor for closing the possible gap to the rubber plunger according to an embodiment of the invention.

Figure 6 schematically illustrates a possible design of the piston-washer to allow laser light to measure the distance of the both piston washer and the rubber plunger to eliminate the gap to the rubber plunger.

DETAILED DESCRIPTION OF AN EMBODIMENT

In the following, it will be described how the present invention provides technical solutions to the benefits listed above under the heading "Object of the invention". The injector is also referred to as "pen injector device" or "injection device" or "pen injector".

Using this semi durable Pen injector device 1 will reduce the number of the disposed components significantly in disposable Pen injectors from several plastic and sometimes metal components to only one single plastic component with better opportunity to make it with biodegradable materials. The Durable module 2, as part of the Pen injector 1 includes all the Hardware needed for injecting the accurate doses, once the drug type is identified. The only disposable component is the Cartridge-holder 3 (figure 1), which allows the Cartridge 4 with unique drug type to be inserted inside it ("snap on" a one-way insertion). The drug companies carry out this process. The content of the sellable packages 5 from drug companies will then include the Cartridge-holders 3 and Cartridges 4. This would be in contrast to the present Packages, which include completely disposable Pen injectors with significantly more components to be disposed of after usage.

The drug type is identified through a unique code 6 on the Cartridge-holder 3 (figure 2). This code could be a QR or Bar-code printed or attached on the Cartridge-holder 3. The scanner 7 reading the code information is part of the Durable module 2 (figure 5). The code 6 may include information about the dose size increment unique for each specific drug type. This information may be displayed on the Durable module 2. The code 6 may include information about the exact movement of the Piston-rod 8 (figure 5) corresponding to the set dose size by the users. The code 6 may include information about the total content of the drug inside the Cartridge 4, allowing the Durable module 2 to communicate the exact content left inside the cartridge 4 at any time to patients. This is possible since the Durable module 2 has the displacement information of the Piston-rod movement. The code 6 may also include information about environmental and regulatory requirements desired to be available on the display 9 (figure 4) of the Durable module 2 unique for each specific drug type. The code 6 may include the brand information to be visible on the display 9, such as OLED, around the body of the durable module 2 achieving clear differentiation and reducing the risk of mix-up. The whole visual identity of outer body of the Durable module 2 is decided by the drug companies and shown on the display 9 (figure 3). The display 9 may allow users to see the information in a room with insufficient lighting. Both the visual identity and the recognition of the drug type by the Durable module 2 will be strong mitigations preventing mix-up scenarios at the same level as the prior art Disposable Pens.

Comparing to the majority of the reusable Pen injector devices available on the market, where patients handle all three parts (Cartridge, Cartridge-holder, and the injection module), the Semi durable solution according to the present invention will make it possible to have to handle only two parts (Cartridge-holder 3 and Durable module 2) and thereby achieve more simplicity. The Cartridges 4 will be more protected against chips and cracks since they are inside the Cartridge-holder 3 at all times, as opposed to prior art durable devices where the Cartridges are outside the Cartridge-holders until they are inserted into it by the users.

The Cartridge-holder 3 includes a thread 10 where a needle (not shown) can be attached. The Cartridge-holder thread 10 may also allow for a quick fit attachment to the needle, such as bayonet fit design 11 (figure 2). The Cartridge-holder 3 when positioned inside the Durable module 2 (attachment completed) will have limited conductive area or another type of design element (figure 2) for activating a switch 23 allowing the system to wake-up and collect information from the QR or Bar-code 6. In addition, the switch may give information each time the Cartridge-holder is being detached for giving the signal to the Durable module 2 to return Piston-rod 8 back to the start position. A thread design or bayonet design may be used for attachment between Cartridge-holder 3 and Durable module 2. Therefore, one or more codes and wake-up activation feature may be needed on the Cartridge-holder 3. The Durable module 2 of the illustrated embodiment includes a micro loudspeaker 12 providing different types of signals to the user during dial-up, dial-down and injections (figure 4). The solution may be further developed to allow the Durable module 2 to say the actual set dose in the local language for people with poor vision. The local language may be activated when paring the Durable module 2 to a mobile phone App 13 as shown in figure 1. The mobile phone App 13 receives data from the Durable module 2 and may communicate the data to the Cloud 14 and through OTA, the App may download update from Cloud 14 into the Durable module 2.

The Cartridge-holder 2 is preferably made of transparent plastic allowing clear vision to the drug through the glass Cartridge 4.

A durable Cap 5 may be snapped to the Cartridge-holder 3 or Durable module 2 for protecting the drug against sunlight (figure 4).

Since drug companies use different types of glass Cartridges 4, the inside design of the Cartridge-holder 3 is configured to adapt for each individual type of the glass Cartridge 4.

A battery driven motor 16 such as Stepper or DC motor drives the Piston-rod 8 forward, after receiving the signal from the control system which may e.g. be arranged in the space 24 for electric hardware (figure 5). This may be achieved by relative rotation between the Piston-rod 8 with thread design and a nut. The exact dose size increment is known by information received from the identifier code 6 on the Cartridge-holder 3. The set dose is decided by the user after recommendation of Health Care Professional. In the illustrated embodiment, the Durable module 2 has finger touch area 17 in a circular shape, which may be positioned on the opposite side of the Cartridge-holder 3 (figure 4). This will allow the user to dial up when going clockwise and dial down when going anticlockwise, until the desired dose size is chosen. The set dose is shown on the display 9 on the outer body of the Durable module 2 according to the visual identity chosen by the drug company. Due to the lighting of the display 9, it will be possible to read the information on the Durable module 2 even with poor surrounding light. A Dome-switch 18 (figure 5) or any other signal activated by the user will confirm the set dose before the motor 16 drives the Piston-rod 8 forward for injecting the set dose. The Dome-switch 18 may be positioned on the top of the Durable module 2 on the opposite side of the insertion of the Cartridge-holder 3. The Dome-switch 18 could have multi-functionality such as confirmation of set dose and initiation of the injection. The confirmation and injection of the set dose could also be achieved by finger touch on the (OLED) display 9.

The battery 19 is rechargeable either with wire connection 20 (figure 5) directly to the Durable module 2 or wireless inductive recharge. For the inductive charger an etui may be used as inductive charger with possibility for including a power bank for travel purpose.

A timer (not shown) will be activated registering the time and date of the injections relative to the previous injection and once all data has been transferred out of the Durable module 2 and received by another device such as an App on the mobile phone 13 the time and date will be synchronised with the actual time and date of the mobile phone. All data including the drug type and dose size information will be transferred using NFC (Near Field Communication) or BLE (Bluetooth Low Energy) technology.

The Durable module 2 may save data from several injections and store the data before transmitting them to a receiver such as mobile App 13.

If a drug type is unknown to the Durable module scanner 7, due to newly being launched, the App 13 will have the ability to recognize the new drug type by scanning a QR or bar code on the packaging material 5 or on the Cartridge-holder 3. Once the drug type is recognized by the App, the needed information will be downloaded on to the Durable module 2 through the OTA (Over The Air) technology and thereby enabling the Durable module 2 to recognize the code 6 on the Cartridge-holder 3 going forward (figure 1).

The paring between the Durable module 2 and the App 13 is made possible by confirming the unique number shown on the display of the Durable module 2 or on the mobile phone. The parring is needed only once. For further increasing the safety and preventing the mix-up situation for households with multiple users of injector devices with similarity, a simple face or fingerprint recognition technology could be included into the Durable module. Hence, the owner or limited number of caregivers will be allowed to activate the injection of the drug.

Enabling the Durable module 2 to act as both multiple dose sizes, fixed dose size and multi-fixed dose size handled by the same injection device requires the control system of the Durable module 2 to know the exact position of the rubber Plunger 20 inside the Cartridge 4. This can be achieved by several sensor solutions such as Laser distance measurement, where from next to the Piston-rod 8 the Laser light will measure the exact position of the rubber Plunger 20. Since the position of the Piston-rod 8 is well defined the system will, before taking any injection, make sure that there is no gap between the rubber Plunger 20 and Piston-rod 8.

In the solution catalogue for the Laser distance measurement, the Laser light may collect position data from both rubber Plunger 20 and a Piston-washer 21 (figure 6), which is attached to the Piston-rod 8. In this solution, the Piston-rod 8 must rotate and move forward during the injection. The Piston-washer 21 is locked rotationally to the piston-rod 8. The Piston-washer 21 has a few well-defined holes on it for allowing the Laser light passing though and measure the position of the rubber Plunger 20, which lays beneath the Piston-washer 21. Since the Pistonwasher 21 rotates together with the Piston-rod 8 and relative to the source of the Laser light, the Laser distance measurements can be made for both rubber Plunger 20 and Piston-washer 21 using same laser source. Hereby any identified gap between the rubber Plunger 20 and Piston-washer 21 can be eliminated by rotating the Piston-rod 8 forward and close the gap. To prevent unintentional injection when measuring the gap, the Piston-rod 8 needs to make a backward rotation, allowing the Laser measurements to complete and once the calculation is completed the Piston-rod 8/ Piston-washer 21 will rotate forward to close the gap. This will be done before any injection, without being noticed by the user. To detect a blocked needle for Laser measurement solutions, once the injection is completed, the Piston-rod 8 may move slightly backwards. If the Laser measures the rubber Plunger 20 moving backwards, this would indicate that there is still pressure inside the Cartridge 4, which would signal the injection is not completed and the possible cause is the blocked needle.

As alternative solution to eliminate the gap between the Piston-rod 8 and rubber Plunger 20 is a micro pressure sensor 22 which may be positioned in front of the Piston-rod 8 (figure 5). The pressure will increase at the exact moment when the surface of the rubber Plunger 20 touches the sensor 22 in the beginning of the injection. If no pressure is measured this means that there is a gap, which needs to be eliminated. Moreover, when the pressure at the end of the injection goes back to zero, it means the end of actual injection and the needle can be removed from the skin of the user. If the pressure does not go back to zero, this gives an indication of a possibly blocked needle, which is often the root cause for missing dose due to not removing needle from the Pen injectors from previous injection. In this situation, both the Mobile App and the Durable module can give a warning to the user. Since the pressure sensor 22 can detect the blocked needle, a flow check would not be necessary anymore. In order to remove the air from Cartridge 4, priming may be required.

Although the present invention has been described in connection with the specified embodiments, it should not be construed as being in any way limited to the presented examples. The scope of the present invention is set out by the accompanying claim set. In the context of the claims, the terms "comprising" or "comprises" do not exclude other possible elements or steps. Also, the mentioning of references such as "a" or "an" etc. should not be construed as excluding a plurality. The use of reference signs in the claims with respect to elements indicated in the figures shall also not be construed as limiting the scope of the invention. Furthermore, individual features mentioned in different claims, may possibly be advantageously combined, and the mentioning of these features in different claims does not exclude that a combination of features is not possible and advantageous.