WO2025202047A1

WO2025202047A1 - Wearable injector and injection device including this wearable injector

Info

Publication number: WO2025202047A1
Application number: PCT/EP2025/057759
Authority: WO
Inventors: Vincent DELOBELLE; Nicolas BESSON; Gilles BERNÈDE; Salim Bouyahiaoui; Aurélien GAUTIER
Original assignee: Becton Dickinson France SA
Current assignee: Becton Dickinson France SA
Priority date: 2024-03-28
Filing date: 2025-03-21
Publication date: 2025-10-02
Anticipated expiration: 2026-09-28

Abstract

Wearable injector and injection device including this wearable injector The wearable injector (1) includes: a housing (10), an injection mechanism (20) arranged within the housing (10) to control injection and circulate a medical product from an external reservoir (2) to an injection site, the injection mechanism (20) including a catheter insertion mechanism (214) An attachment member (30) is arranged for attaching the housing (10) to the injection site. An inlet port (113) is arranged through the housing (10) and in fluid communication with the catheter insertion mechanism (214). A connector (40) is configured to fluidly connect the inlet port (113) of the housing (10) to the external reservoir (2).

Description

Wearable injector and injection device including this wearable injector

The present invention relates to a wearable injector and to an injection device including this wearable injector.

In this application, the distal end of a component or of a device is to be understood as meaning the end closest to the injection site, and the proximal end is to be understood as meaning the end furthest from the injection site. Likewise, in this application, the “distal direction” is to be understood as meaning the injection direction, i.e. towards the injection site, and the “proximal direction” is to be understood as meaning the opposite direction, away from the injection site.

Wearable injectors are injectors configured to be worn by a patient, and more specifically attached to the patient’s skin, during a predetermined time period, usually ranging from several minutes or hours to several days. The wearable injectors are configured to deliver a predetermined volume of medical product at a predetermined flow rate and at a predetermined time after activation.

The medical product is prefilled in a reservoir of the wearable injector or is transferred from a prefilled syringe or a vial to a reservoir of the wearable injector by a healthcare worker, such as a nurse, before activation and application of the wearable injector onto the patient’s skin. The prefilled syringe is typically contained in a kit packaging which also contains the wearable injector.

Wearable injectors typically include a reservoir, such as a cartridge, a syringe or a bag, for containing the medical product and an injection mechanism for expelling the medical product contained within the reservoir into an injection site at the predetermined time, volume and flow rate. The reservoir rarely is a vial requiring a control of its orientation to avoid air injection.

It is known from document WO2012072555 a multi-reservoir pump patch. The document WO2022261095 discloses an apparatus for filling a fluid delivery device. The document US20240017001 discloses a fluid pumping system. It is further known from document US2019224407 a fluid injector.

Usually, it is not possible to make the wearable injector switch from one container to another (syringe/bag/cartridge); a change of the container type would indeed require a mechanical and fluidic adaptation, i.e. a full redevelopment, of the wearable injector. Besides, for large drug volume, such as for example 10 to 50 mL, the reservoir may be cumbersome and somewhat heavy. This involves wearable injectors that are uncomfortable to wear and that can lead to problems such as injection depth modification during injection.

There is therefore a need for a wearable injector that alleviates some or all of the aforementioned drawbacks of the prior art, and more specifically for a wearable injector that can have a reservoir designed to contain a significant volume of the medical product without being as cumbersome and as uncomfortable as the wearable injectors of the prior art.

In this context, an aspect of the invention is a wearable injector including: a housing, an injection mechanism arranged within the housing to control injection and circulate a medical product from an external reservoir to an injection site, the injection mechanism including a catheter insertion mechanism, an attachment member for attaching the housing to the injection site, an inlet port arranged through the housing and in fluid communication with the catheter insertion mechanism, a connector configured to fluidly connect the inlet port of the housing to the external reservoir.

The wearable injector of the invention is therefore separate from the reservoir. This enables to reduce the size of the housing which does not need to contain the reservoir. The reservoir and the housing can be placed at different locations, can have various relative orientations and may move relative to each at some degree to adapt to the gestures and movements of the patient wearing the injector and the reservoir. The remote location of the reservoir is allowed by the connector which establishes a flexible fluid communication between the reservoir and the wearable injector.

The wearable injector is configured to be worn by a patient and to inject a predetermined dose of a medical product at a predetermined while being worn by the patient.

The catheter insertion mechanism is configured for inserting a catheter into the patient’s skin at an injection site.

The injector of the invention may further include some or all of the features listed below.

The connector is arranged outside the housing.

In an embodiment, the connector includes a flexible tube defining a fluidic channel for guiding the medical product from the external reservoir to the housing.

In an embodiment, the connector includes an adapter comprising any of: a luer, a septum, a spike interface or a vial adapter. The adapter may be configured to connect the inlet port to the external reservoir. The adapter may be directly arranged at the inlet port, or may be indirectly connected to the inlet port via the flexible tube when the adapter is arranged at proximal end of the flexible tube.

In an embodiment, the inlet port is arranged through a lateral face of the housing.

In an embodiment, the connector includes a valve configured to allow priming of the injector before injection.

Preferably, the valve is a one-way valve.

In this embodiment, the valve includes a liquid barrier preventing the medical product to get out the connector.

In this embodiment, the connector includes an air detection unit arranged at or downstream the valve in order to detect passage of air in the connector.

In this embodiment, the connector includes an inlet opening configured to allow air to get in the connector to push the medical product towards the inlet port.

In an embodiment, the connector includes one or more detection units configured to detect one or more of: a connection between the connector and the reservoir, temperature of the medical product, presence of air within the connector, a flow parameter of the medical product circulating inside the connector.

The detection units may include any one of: a switch, an air detector, a temperature probe, a doppler probe, or any tubular thin probe.

Another aspect of the invention is a wearable injection device including a wearable injector as above-described, and an external reservoir located outside the housing of the wearable injector, the external reservoir being configured to be fluidly connected to the inlet port of the wearable injector via the connector.

The external reservoir is independent from the housing of the wearable injector, i.e. is not fixed to the housing. The only connection between the reservoir and the housing is the connector, and possibly the attachment member when the reservoir and the housing share the same attachment member. The reservoir is located outside the housing. That is, the housing cannot accommodate the reservoir. The reservoir is thus detached, separate from the housing. This offers remote, detached, movable, away from, independent. The housing is thus less cumbersome, and the reservoir can be placed at a location where the reservoir does not annoy the patient.

In an embodiment, the injection device includes a same attachment member for attaching the housing and the reservoir to the patient.

That is, the injection device includes a single attachment member shared by the housing and the external reservoir. The attachment member is flexible. The reservoir and the housing are thus free to move relative to each other while being worn by the patient. In an embodiment, the injection device includes an attachment member for attaching the reservoir to the patient, the attachment member of the reservoir being distinct from the attachment member of the housing.

In an embodiment, the wearable injection device includes a remotely readable data unit, such as a RFID tag or a QR code, arranged on the reservoir, and a reader unit configured to read data contained in the data unit.

The terminal may be a smartphone or may be included in the wearable injector, for instance contained within the housing.

In an embodiment, the injection device includes a second external reservoir located outside the housing of the wearable injector and configured to be fluidly connected to the inlet port of the wearable injector via the connector.

The invention and the advantages arising therefrom will clearly emerge from the detailed description that is given below with reference to the appended drawings as follows :

Figure 1A is schematic view of a wearable injector according to an embodiment of the invention,

Figure 1 B is a perspective view of a wearable injector according to an embodiment of the invention,

Figures 2-11 are perspective views of wearable injectors according to embodiments of the invention,

Figures 12A isa schematic view of a tube of a wearable injector according to an embodiment of the invention,

Figure 12B is a schematic view of a tube of a wearable injector according to the embodiment of Figure 12A, during filling of the tube,

Figure 12C is a schematic view of a tube of a wearable injector according to the embodiment of Figure 12A, during injection,

Figures 13A-13C are schematic views of a tube of a wearable injector according to an embodiment of the invention,

Figure 14A is a schematic view of a tube of a wearable injector according to an embodiment of the invention,

Figure 14B is a cross section view of the tube of Figure 14A,

Figure 15A is a schematic view of a tube of a wearable injector according to an embodiment of the invention,

Figures 15B and 15C are cross section views of the tube of Figure 15A, Figure 16 is a schematic view of a wearable injector and system according to an embodiment of the invention, Figure 17 is a schematic view of a wearable injector and system according to an embodiment of the invention,

Figure 18 is a schematic view of a wearable injector according to an embodiment of the invention.

The different features of the embodiments can be used in combination with and used with other embodiments as long as the combined parts are not inconsistent with or interfere with the operation of the device and assembly. This invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein are capable of being modified, practiced or carried out in various ways. The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms "connected," "coupled," and "mounted," and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms "connected" and "coupled" and variations thereof are not limited to physical or mechanical connections or couplings. In contrast, when an element is referred to as being "directly connected" or "directly coupled" to another element, there are no intervening elements present. Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It will be further understood that terms used herein should be interpreted as having a meaning consistent with their meaning in the context of this specification and the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Further, terms such as distal, proximal, up, down, bottom, and top are relative, and are to aid illustration, but are not limiting. Relative terms such as "below" or "above" or "upper" or "lower" or "horizontal" or "vertical" may be used herein to describe a relationship of one element to another element as illustrated in the Figures. It will be understood that these terms and those discussed above are intended to encompass different orientations of the device in addition to the orientation depicted in the Figures. The embodiments are not intended to be mutually exclusive so that the features of one embodiment can be combined with other embodiments as long as they do not contradict each other. Terms of degree, such as “substantially”, “about” and “approximately” are understood by those skilled in the art to refer to reasonable ranges around and including the given value and ranges outside the given value, for example, general tolerances associated with manufacturing, assembly, and use of the embodiments. The term “substantially” when referring to a structure or characteristic includes the characteristic that is mostly or entirely present in the structure. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. It will be understood that, although the terms first, second, etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, a first element could be termed a second element, and, similarly, a second element could be termed a first element without departing from the scope of the present disclosure. For simplification, the parts or elements of one embodiment which are found identically or similarly in the other embodiment will be identified using the same numerical references and will not be described again.

With reference to Figure 1A is shown a wearable injector 1 according to an embodiment of the invention. The wearable injector 1 is configured to be attached to a patient, for instance to the patient’s skin, in order to inject, at a predetermined time, a predetermined volume at a predetermined flow rate of a medical product contained within a reservoir 2.

As illustrated in Figures 1 A and 1 B, the wearable injector 1 of the invention includes a housing 10, and an attachment member 30 for attaching the housing 10 to a supporting site, such as the patient’s skin or clothes, and a connector 40 for fluidly connecting the wearable injector 1 to a reservoir 2 containing a medical product. The wearable injector 1 may further include an injection mechanism 20 and a catheter insertion mechanism 214 contained within the housing 10 for inserting a flexible catheter into an injection site in order to deliver the medical product. More details about the injection and the catheter insertion mechanisms may be found for instance in the patent document US10737038B2.

The housing 10 may be in the form of a parallelepipedic box configured to contain the injection mechanism and the catheter insertion mechanism 214. Instead being parallelepipedic, the housing 10 may otherwise be cylindrical, hemispherical or of any other suitable shape The housing 10 is fixed with respect to the attachment member. The housing 10 may be made of two parts (not shown): a base secured to the attachment member 30 and a shell attached to the base. The housing 10 may include a proximal face 110, a distal face (not shown) attached to the attachment member 30, and lateral faces 111. The proximal face 110 may include an opening 112 allowing extension of an activation button 213 therethrough. The housing 10 further includes an inlet port 113, which may be arranged through one of the lateral faces 111 , for establishing a fluid connection between the reservoir 2 and the injection mechanism 20, such that the medical product can flow from the reservoir 2, which is outside the housing 10, to the injection mechanism 20, which is inside the housing 10. This inlet port 113 is therefore configured to receive the connector 40 of the wearable injector 1. In an embodiment not shown, the inlet port 113 may be arranged through any other lateral face or through the proximal face 110. The connector has two ends 412, 413: one first end 413 configured to be connected to the inlet port 113, and an opposite second end 412 configured to be connected to the reservoir 2. This second end 412 may include an adapter 410 such as a luer.

The attachment member 30 may be a patch configured to be attached to the patient’s skin. The patch may include an adhesive layer (not shown) allowing attachment of the injector 1 to the injection site, and a liner (not shown) configured to protect the adhesive layer before use of the injector 1. The adhesive layer may be fixedly attached, for example glued or hot sealed, to the housing 10 of the injector 1 . The liner may be configured to be peeled off before attachment of the injector 1 to the patient’s skin. The patch may be flexible.

It is important to note that the wearable injector 1 of the invention is separate from the reservoir 2 containing the medical product. Thus, the housing 10 of the wearable injector 1 does not contain the reservoir 2, which is independent from the wearable injector 1 and which can be located remote from the housing 10 of the wearable injector 1 and outside the housing 10 of the wearable injector 1. Therefore, the housing 10 of the wearable injector 1 can have a reduced size, which makes it less cumbersome. Besides, the fact that the reservoir 2 is separate and remote from the housing 10 enables to place the reservoir 2 at a location where disomfort for the patient is substantially reduced. The separation of the reservoir 2 from the housing 10 allows for relative movements between the reservoir 2 and the housing 10. This renders the reservoir 2 and the wearable injector 1 of the invention more convenient to wear for the patient, whose gestures are not hindered by a too rigid and cumbersome injector 1 , especially when the reservoir 2 and the injection mechanism are designed to contain and inject high volumes of the medical product.

The connector 40 is configured to fluidly connect the housing 10 to the reservoir 2, whatever the location of the reservoir 2 with respect to the housing 10, and wahtever movements that the patient may accomplish while wearing the wearable injector 1. More specifically, the connector 40 may include an adapter 410 configured for establishing a secure tight connection with the reservoir 2, and may further include a tube 411 for conducting the medical product from the location of the reservoir 2 to the inlet port 113 of the housing 10. The connector 40, or its tube 411 , may be directly connected to an adapter 410 of the reservoir 2.

The tube 41 1 extends between the housing 10 and the reservoir 2. Preferably, the tube 411 is attached to the housing 10, and thus is part of the housing 10. Alternatively, the tube 411 may be attached to the reservoir 2 and thus be part of the reservoir 2. The tube 411 is flexible so that the tube 411 can bend depending on the locations of the housing 10 and of the reservoir 2, and depending on the gestures of the patient when the patient is wearing the injector 1. The tube 411 may be made of a transparent or translucent material. The tube 411 can be placed between the housing 10 and an adapter 410 of the reservoir 2 or between two adapters 410, one fixed to the housing 10 and one fixed to the reservoir 2.

With reference to Figure 1A, the tube 411 includes a proximal end 412 provided with an adapter 410, a distal end 413, and defines at least one fluidic channel 414, Figure 14A, for circulation of the medical product from the proximal end 412 to the distal end 413, and thus from the reservoir 2 to the fluid path of the housing 10.

The adapter 410 may be arranged at the proximal end 412 of the tube 411 for securing the tube 411 to the reservoir 2. Alternatively (Figure 1 B), the adapter 410 may be arranged at the inlet port 113 of the housing 10 for connecting the tube 411 of the reservoir 2 to the inlet port 113 of the housing 10. The adapter 410 may be any one of: a luer, a septum, a spike interface, or a vial adapter 410 with integrated air input. The type of adapter 410 depends on the type of reservoir 2. When the reservoir 2 is a bag or a syringe with a luer tip, the adapter 410 may be a luer or a spike. When the reservoir 2 is a syringe with a needle, the adapter 410 may be a septum. When the reservoir 2 is a cartridge, the adapter 410 may be a spike interface. When the reservoir 2 is a vial, the adapter 410 may be a vial adapter 410.

The invention also relates to a system including the above-described wearable injector 1 , a reservoir 2, an attachment member 3 for attaching the reservoir 2 to the supporting site, and a fastener 4 for fastening the reservoir 2 to the attachment member 3. As will be explained in further details below, the housing 10 and the reservoir 2 may share the same attachment member 3, Figures 2-3 and 5-6, or may each have their respective attachment member 3, 30, Figures 9-11 .

With reference to Figures 2-11 , the reservoir 2 may be of different types and shapes. The reservoir 2 may be a container such as a syringe (Figures 2-3 and 7-9), a bag (Figures 5-6), or a vial (Figures 10-11). The reservoir 2 may also be a cartridge (not shown).

The reservoir 2 is configured for containing a volume of a medical product, and specifically high volumes of the the medical product, such as volumes greater than or equal to 10 mL, preferably between 10 mL and 50 mL, or even volumes greater than or equal to 50 mL.

The reservoir 2 is independent from the housing 10. That is, the reservoir 2 is not contained within the housing 10, but is rather located outside the housing 10. This permits some sort of freedom of movement between the reservoir 2 and the housing 10, so that the reservoir 2 and the housing 10 are not so uncomfortable to wear for the patient. This also permits to have a reduced size housing 10 and to limit the cumbersomeness of the system. The reservoir 2 may connected by the connector 40 only. Sometimes, they may also be mechanically connected by a common attachment member 3, 30, as illustrated in Figures 2-6, but the attachment member 3, 30 is made of a flexible material so that the reservoir 2 and the housing 10 can still move with respect to one another. The attachment member 3 may be a patch configured to be attached to the patient’s skin. The patch may include an adhesive layer (not shown) allowing attachment of the reservoir 2 to the patient’s skin. The patch may be flexible.

The attachment member 3 may otherwise be configured for attachment to the patient’s clothes, for instance the attachment member 3 may be a clipping member configured to be attached to the patient’s belt as illustrated in Figure 8, or to the patient’s trousers or a pocket. In another embodiment, for example when the reservoir 2 is a vial, the attachment member 3 may be a necklace configured to maintain the vial in a predetermined vertical position, hung around the patient’s neck. In this embodiment, the necklace may include a gyroscope system so that the reservoir 2 (vial) is maintained head down; therefore, the bubble in the vial can always be on the top so that the full dose of the medical product can exit the vial. This may be interesting when the injection is short and is not to be done in a long time so that the patient can mainly stay in a seated position when wearing the injector 1 .

In some embodiments (Figures 2-3 and 5-6), the housing 10 and the reservoir 2 share the same attachment member 3, 30. In other embodiments (Figures 9-11), the attachment member 30 of the housing 10 and the attachment member 3 of the reservoir 2 are distinct from each other. That is, the attachment members 3, 30 are separate from each other and do not form a single common attachment member.

The fastener 4 may be in the form of snap-fit elements (Figures 2-3, 9-10), or securing rings (Figures 3-4, 7-8), or adhesive straps (Figures 5-6), configured to secure the reservoir 2 to the attachment member 3. The fastener 4 may be configured to removably secure the reservoir 2 to the attachment member 3. The fastener 4 may be fixed to the support by any appropriate means. The fastener 4 may be configured to adapt several diameters of reservoirs 2, so that cylindrical containers of different diameters may be secured to the attachment member 3 via the fastener 4.

The Figures 12A to 15C illustrate variants of the connector 40.

With reference to Figures 12A-12CThe connector 40 may include some or all of a valve 415 and a hydrophobic filter 416.

The valve 415 may be a one-way valve 415 arranged to fluidly communicate with the fluidic channel 414 of the tube 411 . The valve 415 is configured to allow a priming operation, that is to say to evacuate the air contained within the fluidic channel 414 before injection of the medical product into the injection site. The valve 415 thus allows the air contained within the fluidic channel 414 to get out the the tube 411 (Figure 12B), but also prevents the outside air to get in when vacuum is created by the pump and during injection (Figure 12C). Under pressure, the air contained within the fluidic channel 414 is blowed towards the one-way valve 415, and exits the fluidic channel 414. The pressure may for instance be exerted by a user pressing the bag when the reservoir 2 is a bag, or by pressing a plunger rod of the syringe when the reservoir 2 is a syringe, or may be due to gravity when the reservoir 2 is a vial. The valve 415 is arranged as close as possible to the pump 215, and may be arranged within the housing 10. In some embodiments, as illustrated in Figures 13A-13C, the valve 415 may be at or near the distal end 413 of the tube 411 , and anyway closer to the distal end 413 than to the proximal end 412 of the tube 411. The one-way valve 415 may include for instance a pierced membrane that can open in only one direction, or a ball 417 urged by a spring 418. During filling (Figure 12B), the valve 415 opens so that air exits the fluidic channel 414. During injection (Figure 12C), the sucked medical product will help keep the valve 415 closed.

The hydrophobic filter 416 is arranged on the valve 415 to allow the air contained within the fluidic channel 414 to exit the valve 415 while preventing liquids such as the medical product to exit the fluidic channel 414. The filter forms a liquid barrier.

The volume of the fluidic channel 414 may form a dead volume at the end of injection. Medical products may be costly and waste of medical products trapped in the so-called dead volume is undesirable. With reference to Figures 13A-13C, the connector 40 may further include an inlet opening 419 in fluid communication with the fluidic channel 414 of the the tube 411. The inlet opening 419 is configured for limiting the dead volume, that is to say to limit the volume of medical product that stays trapped in the fluidic channel 414 at the end of injection. The inlet opening 419 is configured to let air get in the fluidic channel 414 at the end of injection, i.e. when the remaining volume of medical product passes through the fluidic channel 414. The air 426, Figure 13C, getting inside the fluidic channel 414 behind the medical product permits to expel the rest of medical product 427 in the tube 411 towards the injection site, as illustrated in Figure 13C. The inlet opening 419 is arranged upstream the valve 415. Preferably, the inlet opening 419 is arranged as close as possible to the reservoir 2, for instance at the proximal end 412 of the tube 411 , or near the proximal end 412 of the tube 411 to limit the dead volume.

The inlet opening 419 has a liquid barrier 420, and specifically a filter such as a hydrophobic filter, so that the medical product cannot exit the fluidic channel 414 of the tube 411 during filling, when a pressure is applied, Figure 13B. The liquid barrier is however configured to allow air to get in when a vacuum is applied to it, Figure 13C, meaning when there is no more fluid in the reservoir 2 and when a pump of the wearable injector is working.

As illustrated in Figures 13A-13C, the connector 40 may further include a sensor, or air detection unit 425, configured to detect air/liquid transition in the fluidic channel 414 during injection, so that injection can be stopped once air is detected. The sensor may also be used to confirm priming of the fluidic channel 414 of the tube 411 during filling. The sensor is arranged downstream the inlet opening 419, and may be arranged at the valve 415, or preferably downstream the valve 415, i.e. between valve 415 and pump 413, to limit the dead volume even more.

With reference to Figures 14A-15C, the tube 411 may include one or more inner channels or cavities 422, in addition to the above-described fluidic channels 414. These inner channels are configured to accommodate additional functions, such as detection of connection between the adapter 410 of the injector 1 and the adapter 410 of the reservoir 2, or detection of air within the fluidic channel 414 as above-explained. That is, the connector 40 may be configured to include one or more detection units 421 . In Figure 14A, the tube 411 includes an inner channel accomodating an electrical wire 423 and a switch 421 for detecting proper connection between the reservoir 2 and the connector 40. The switch is in communication with a controller located in the housing 10 of the injector 1. Therefore, operation of the injector 1 may be conditioned to a proper connection between the connector 40 and the reservoir 2. It is contemplated that the switch or sensor may equip the connector 40 even if there is no tube 411. In Figures 15A-15C, the tube 411 may include another inner channel 422 accommodating a temperature probe 424 for measuring the temperature of the medical product. It should be noted that other functions may be added to the injector 1 , such as but not limited to: detection of the presence or not of the reservoir 2, detection of air bubbles in the medical product through detection of air in the fluidic channel 414, flowmeter through an integrated doppler probe.

With reference to Figure 16, the reservoir 2 (here a vial) may include a RFID tag and the wearable injector 1 may include a RFID reader so that the drug can be directly recognized by the system and its injection parameters set in the system. Alternatively, as illustrated in Figure 17, the reservoir 2 may include a RFID tag 210 or QR code 211 that can be read by a smartphone 5; depending on retrieved information, parameters of the injection may be sent by the smartphone 5 and implemented into the wearable injector 1 via wireless connection, such as Bluetooth® or the like, or via direct wire connection before starting the injection process. This may allow dosage of the medical product to be injected, for regular treatment or for treatment follow-up, the full dose of treatment being contained in the reservoir 2. The reservoir 2 may be registered through an application which controls the dosage, i.e. set the appropriate volume to inject at the predetermined flow rate.

With reference to Figure 18, the system of the invention may include more than one reservoirs 2, such as for instance two reservoirs 2 that are connected to the connector 40, each reservoir 2 containing a different medical product. The medical products may transit by the same fluidic channel 414 of the connector 40, or by two different fluidic channels 414 of the connector 40. Having more than one reservoir 2 connected to the housing 10 may be useful for multi-drug treatments, or for drug reconstitution when the medical products contained in each of the reservoir 2 mix in the connector 40 before injection. It is readily understandable from the above description that the wearable injector 1 and system of the invention allow for wearing the housing 10 (which includes the electronic circuitry and the injection mechanism 20) separately from the reservoir 2. This separation enables to benefit from a housing 10 having a reduced size, since the housing 10 no longer contains the reservoir 2 as in the state of the art, and also enables some relative movement between the reservoir 2 and the housing 10 since they are no longer rigidly fixed to each other. The wearable injector 1 and system of the invention can thus be worn with higher comfort by the patient, even for high volumes of medical products which may involve a quite cumbersome reservoir 2. It is to be understood that the present invention is not limited to the embodiments described above and illustrated in the drawings; rather, the skilled person will recognize that many changes and modifications may be made within the scope of the appended claims.

It is of note that, as reflected by the above description : the housing 10 is devoid of any reservoir for storing the medical product inside the housing 10, i.e. devoid of any internal reservoir, since the medical product is all stored by the external reservoir 2. The external reservoir 2 and the housing 10 are not fixedly connected to each other; they are moveable relative to each other. The external reservoir 2 is configured to be attached to the patient’s skin. The connector 40 extends outside the housing 10.

Claims

1. Wearable injector (1) including: a housing (10), an injection mechanism (20) arranged within the housing (10) to control injection and circulate a medical product from a remote external reservoir (2) to an injection site, the injection mechanism (20) including a catheter insertion mechanism (214), an attachment member (30) for attaching the housing (10) to the injection site, an inlet port (113) arranged through the housing (10) and in fluid communication with the catheter insertion mechanism (214), a connector (40) configured to fluidly connect the inlet port (1 13) of the housing (10) to the remote external reservoir (2), wherein the connector (40) includes a flexible tube (411) defining a fluidic channel (414) for guiding the medical product from the remote external reservoir (2) to the housing (10).

2. Wearable injector (1) according to the preceding claim, wherein the connector (40) includes an adapter (410) comprising any of: a luer, a septum, a spike interface or a vial adapter.

3. Wearable injector (1) according to any one the preceding claims, wherein the inlet port (113) is arranged through a lateral face (111) of the housing (10).

4. Wearable injector (1) according to any one the preceding claims, wherein the connector (40) includes a valve (415) configured to allow priming of the injector (1) before injection.

5. Wearable injector (1) according to the preceding claim, wherein the valve (415) includes a liquid barrier (416) preventing the medical product to get out the connector (40).

6. Wearable injector (1) according to any one of the preceding claims 4 or 5, wherein the connector (40) includes an air detection unit (425) arranged at or downstream the valve (415) in order to detect passage of air in the connector (40).

7. Wearable injector (1) according to any one the preceding claims 4-6, wherein the connector (40) includes an inlet opening (419) configured to allow air to get in the connector (40) to push the medical product towards the inlet port (113).

8. Wearable injector (1) according to any one of the preceding claims, wherein the connector (40) includes one or more detection units (421) configured to detect one or more of: a connection between the connector (40) and the reservoir (2), temperature of the medical product, presence of air within the connector (40), a flow parameter of the medical product circulating inside the connector (40).

9. Injection device (100) including a wearable injector (1) according to any one of the preceding claims, and an external reservoir (2) located outside the housing (10) of the wearable injector (1), the external reservoir (2) being configured to be fluidly connected to the inlet port (113) of the wearable injector (1) via the connector (40).

10. Injection device (100) according to the preceding claim, wherein the injection device (100) includes a same attachment member (3, 30) for attaching the housing (10) and the reservoir (2) to the patient.

11. Injection device (100) according to claim 10, wherein the injection device (100) includes an attachment member (3) for attaching the reservoir (2) to the patient, the attachment member (3) of the reservoir (2) being distinct from the attachment member (30) of the housing (10).

12. Injection device (100) according to any one of the preceding claims 9-11 , wherein the injection device (100) includes a remotely readable data unit, such as a RFID tag (210) or a QR code (211), arranged on the reservoir (2), and a reader unit configured to read data contained in the data unit.

13. Injection device (100) according to any one of the preceding claims 9-12, wherein the injection device (100) includes a second external reservoir (2) located outside the housing (10) of the wearable injector (1) and configured to be fluidly connected to the inlet port