Injection device with sterile sealing member

Abstract

Injection device The injection device (1) includes: a housing (2) containing a reservoir (11) for storing a predetermined volume of a medical product, a patch (22) arranged on the housing (2) for allowing attachment of the injection device to an injection site, and a catheter insertion mechanism (3) including a needle (34), a catheter (32) and a fluidic chamber (5) configured for fluidly connecting the reservoir (11) to the catheter (32) The fluidic chamber (5) is axially movable together with the needle (34) and the catheter (32) between an initial position and an activated position, distally located with respect to the initial position, in which the needle (34) and the catheter (32) are deployed outside the housing (2) in order to penetrate into the injection site. A sealing member (4) is fixedly attached to the catheter insertion mechanism (3) and configured for maintaining sterility before activation of the device (1). The sealing member (4) includes a pricking portion (461) configured to be pierced by the needle (34) during movement of the needle (34) and the catheter (32) towards the activated position.

Description

[0001] INJECTION DEVICE WITH STERILE SEALING MEMBER

[0002] The present invention relates to a wearable injection.

[0003] In this application, the distal end of a component or of a device is to be understood as meaning the end furthest from the user's hand and the proximal end is to be understood as meaning the end closest to the user's hand. Likewise, in this application, the “distal direction” is to be understood as meaning the direction away from the user's hand, and the “proximal direction” is to be understood as meaning the direction toward the user's hand.

[0004] Wearable injection devices are injection devices 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 injection devices are configured to deliver a predetermined volume of medical product at a predetermined flow rate and at a predetermined time after activation.

[0005] The medical product is transferred from a prefilled syringe to a reservoir of the wearable injection by a healthcare worker, such as a nurse, before activation and application of the wearable injection device onto the patient’s skin. The prefilled syringe is typically contained in a closed tight kit packaging which also contains the wearable injection device.

[0006] Usually, the whole packaged medical product is sterilized by means of a gas, such as ethylene oxide (ETO). The packaging then maintains sterility of the wearable injection device contained therein. However, this sterilization method has some drawbacks. The ETO is non- sustainable, and may damage the electronic system of the wearable injection devices. Batteries are subject to risks of explosion. Other sterilization techniques are available, such as beam or irradiation like e-beam, Y-ray or gamma, but they all can damage the electronic system. Besides, since the whole packaging is sterilized, sterility is broken as soon as the user opens the packaging. Consequently, if the injection device is let out of the packaging for a while before use, the catheter and / or the needle, which are exposed to ambiant air, can be contaminated by dust, projection or other.

[0007] Wearable injection devices of the prior art usually include a catheter insertion mechanism including a rigid needle for pricking the injection site and a flexible catheter designed, in an activated position, to extend through a patient’s skin in order to establish a fluid path between a reservoir containing the medical product of the injection device and the injection site. Upon activation of the injection device, the needle and the catheter move from an initial storage position to the activated position. It is important that the needle and the catheter stay in the initial storage position before positive activation by the user, otherwise the injection device is useless. It is for instance known from the document WO2017139741 a wearable drug delivery device. It is known from the document EP1495775 a needle arrangement aimed at allowing a portable drug delivery device to be manufactured in a convenient and cost-effective manner.

[0008] There is therefore a need for an injection device that alleviate some or all of the aforementioned drawbacks of the prior art. More specifically, there is a need for an injection device that prevents inadvertent and premature activation of the catheter insertion mechanism.

[0009] In this context, an aspect of the invention is an injection device including: a housing containing a reservoir for storing a predetermined volume of a medical product, a patch arranged on the housing for allowing attachment of the injection device to an injection site, a catheter insertion mechanism including a needle, a catheter and a fluidic chamber configured for fluidly connecting the reservoir to the catheter, the fluidic chamber being axially movable together with the needle and the catheter between an initial position and an activated position, distally located with respect to the initial position, in which the needle and the catheter are deployed outside the housing in order to penetrate into the injection site, and a sealing member, fixedly attached to the catheter insertion mechanism and configured for maintaining sterility before activation of the device, the sealing member including a pricking portion configured to be pierced by the needle during movement of the needle and the catheter towards the activated position.

[0010] Therefore the catheter in the activated position extends through the sealing member. Before activation, the sealing member keeps sterility of the outlet of the fluidic path. Besides, the sealing member is fixedly attached, and thus does not need to be removed. This simplifies use of the device to the user and prevents against risks of inadvertent and premature activation of the device before use.

[0011] The injection device of the invention may further include some or all of the features listed below.

[0012] The sealing member is not removable. The sealing member is fixed to the fluidic chamber and thus moves together with the fluidic chamber.

[0013] In an embodiment, the sealing member includes one or more fasteners configured for complementarily engaging one or more fasteners of the fluidic chamber.

[0014] The fasteners axially abut against each other. The fasteners may radially protrude or be radially recessed, so as to form a double bend. This improves tightness of the attachment. Possibly, the fastener of the sealing member is a circumferential rib. Alternatively, the fastener of the sealing member is a circumferential groove. This groove may be configured to receive a glue material. Therefore, in an embodiment, the groove accommodates a glue material.

[0015] In an embodiment, the sealing member and the fluidic chamber have radially abutting sealing surfaces.

[0016] The sealing surfaces accordingly define a radial sealing between the fluidic chamber and the sealing member.

[0017] In an embodiment, the sealing surface of the sealing member defines an inner diameter D1 equal to or lower than an outer diameter D2 of the sealing surface of the fluidic chamber.

[0018] In an embodiment, the injection device includes a holder configured for fixedly securing the sealing member to the fluidic chamber.

[0019] The holder may be rigid. The material of the sealing member may be softer than the material of the holder.

[0020] In an embodiment, the holder is a circumferential ring surrounding the sealing member such that the sealing member is caught between the holder and the fluidic chamber.

[0021] The holder may be configured to radially inwardly compress the sealing member against the fluidic chamber.

[0022] In an embodiment, the holder and the sealing member are two distinct components.

[0023] They do not form a single piece. The holder is added on the sealing member during assembly of the device.

[0024] In an embodiment, the holder is an inner ring which is part of the sealing member. The holder and the sealing member thus form a single piece, which may be made of different materials, a rigid material for the holder and a softer material for the sealing member.

[0025] In an embodiment, the sealing member includes a lateral wall having a constant width.

[0026] In an embodiment, the sealing member includes a lateral wall having one or more hinges for controlling deformation of the sealing member.

[0027] The hinges circumferentially extend around the longitudinal axis A such that the sealing member can be axially compressed like a bellows.

[0028] In an embodiment, the hinges are grooves arranged on an outer surface of the lateral wall of the sealing member.

[0029] In an embodiment, the hinges are pre-shaped folds including convex folds axially alternating with concave folds. In an embodiment, an inner diameter defined by the convex folds or, respectively, the concave folds, is distally decreasing.

[0030] In an embodiment, the sealing member is configured to deform in an outward radial direction.

[0031] Therefore, when the device is being activated, the deformation of the sealing member does not hinder axial movement of the needle and of the catheter towards their activated position.

[0032] In an embodiment, the catheter insertion mechanism has an opening allowing passage of the catheter towards the activated position, and a recess extending around the opening for accommodating the deformed sealing member.

[0033] Possibly, the sealing member is made of thermoplastic elastomer (TPE), silicone, polyurethane (PU), polyethylene (PE), polystyrene (PS), or any combination thereof.

[0034] 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 :

[0035] Figure 1 is a perspective view of an injection device according to an embodiment of the invention, in an initial (unactivated) state,

[0036] Figure 2 is a perspective view of an injection device according to an embodiment of the invention, in an activated state,

[0037] Figure 3 is an exploded view of an injection device according to an embodiment of the invention,

[0038] Figure 4 is a perspective view of a catheter insertion mechanism of an injection device according to an embodiment of the invention,

[0039] Figure 5 is an exploded view of a catheter insertion mechanism of an injection device according to an embodiment of the invention,

[0040] Figures 6 to 8 are perspective views illustrating a fluidic chamber of the catheter insertion mechanism of an injection device according to an embodiment of the invention,

[0041] Figures 9A and 9B are cross-section views illustrating a catheter insertion mechanism of an injection device according to an embodiment of the invention, respectively in an initial position and in an activated position,

[0042] Figure 10 is a cross-section view of a sealing member of an injection device according to an embodiment of the invention,

[0043] Figure 11 is a perspective view of a sealing member of an injection device according to an embodiment of the invention,

[0044] Figure 12 is a perspective view of a portion of a sealing member of an injection device according to an embodiment of the invention, Figure 13 is a perspective view of a holder of an injection device according to an embodiment of the invention,

[0045] Figure 14 is a cross-section view of a portion of a catheter insertin mechanism of an injection device according to an embodiment of the invention,

[0046] Figure 15 is a perspective view of a sealing member of an injection device according to an embodiment of the invention,

[0047] Figure 16 is a cross-section view of a sealing member of an injection device according to an embodiment of the invention,

[0048] Figure 17 is a perspective view of a sealing member of an injection device according to an embodiment of the invention,

[0049] Figure 18 is a cross-section view of the sealing member of Figure 17, in an initial (undeformed) position,

[0050] Figure 19 is a cross-section view of the sealing member of Figure 17, in an activated (deformed) position,

[0051] Figure 20 is a perspective view of a sealing member of an injection device according to an embodiment of the invention,

[0052] Figure 21 is a cross-section view of the sealing member of Figure 20, in an initial (undeformed) position,

[0053] Figure 22 is a cross-section view of the sealing member of Figure 20, in an activated (deformed) position.

[0054] 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.

[0055] With reference to Figures 1 -2 is shown a wearable injection device 1 according to an embodiment of the invention. The wearable injection device 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 medical product contained within the wearable injection device 1. In Figure 1 , the injection device 1 is shown in an initial (unactivated) state. In Figure 2, the injection device 1 is shown in an activated state in which a catheter 32 is deployed outside the injection device 1 .

[0056] With reference to Figure 3, the injection device 1 includes a housing 2 formed by a shell 20 and a base 21 , and a patch 22 for attaching the base 21 to the patient’s skin. The injection device 1 may further include various components such as a reservoir 11 in the form of a flexible bag for containing the medical product, a catheter insertion mechanism 3 fluidly connected to the reservoir 11 and configured for inserting a flexible catheter 32 into an injection site in order to deliver the medical product. The reservoir 1 1 may have a volume capacity of 10 to 50 mL. The injection device 1 may further include a pump 12 and a motor 13 for moving the medical product from the reservoir 11 to the injection site, a manifold (not shown) for distributing fluid from an inlet port to the reservoir 11 or from the reservoir 11 to the catheter insertion mechanism 3, a filling port 15 for filling the reservoir, prior to use, with the drug contained in a syringe, a battery 16 and an electronic system 17 for controlling the injection device 1 and for triggering automatic injection of a volume of the medical product at a predetermined time and at a predetermined flow rate. Tubes 18 may fluidly connect the inlet port to the filling port 15, the filling port 15 to the reservoir 11 or the inlet port to the pump 12, and the pump 12 to the catheter insertion mechanism 3. Fluid passageways (not shown) may also be provided in the base 21 and may therefore participate to the fluidic path. The injection device 1 may further include a manual activation button 30 for allowing a user, such as a nurse, to manually trigger insertion of the catheter 32 into the injection site, so that the injection device 1 is activated, and a security cap 19 for preventing access to the manual button 30 during the storage period before use of the injection device 1 , thereby preventing inadvertent activation of the injection device 1 and thus inadvertent deployment of the catheter 32. In the activated state, the activation button 30 may stay depressed as illustrated in Figure 2.

[0057] The injection device 1 may be divided into a connectable electonic module and a fluidic module connectable to each other. The fluidic module may be configured for allowing delivery of medical products having a viscosity ranging from 1 to 50 centipoise (1 to 50 mPa.s).

[0058] A kit may be formed by adding a prefilled syringe to the injection device 1 . The prefilled syringe contains the medical product that will fill the reservoir 11 of the injection device 1 . At the clinic or the hospital, the nurse opens the kit, and uses the prefilled syringe to transfer the medical product to the reservoir 11 of the injection device 1 via the inlet port. After that, the nurse uses the patch 22 of the injection device 1 to attach the injection device 1 to the patient’s skin. The nurse removes the security cap 19 and presses the manual button 30 to cause deployement of the catheter into the injection site. This action may also trigger a countdown of for instance several hours before injection by the electronic system 17. The patient may go home, and when the countdown is over, the electronic system 17 triggers injection, that is transfer of the medical product from the reservoir 11 to the injection site via the catheter 32. The electronic system 17 also warns the patient at the start and / or at the end of the injection operation. When injection is complete, the patient can remove the injection device 1 from his / her skin and throw it in a sharps container or any appropriate waste container. Sterility of the fluidic module is maintained by means of a sealing member 4 arranged at the outlet of the fluidic path, i.e. around the catheter 32 as will be described below.

[0059] With reference to Figures 4 and 5 is shown the catheter insertion mechanism 3. The catheter insertion mechanism 3 is configured for inserting the catheter 32 into the injection site upon activation of the injection device 1 , i.e. when the user presses the manual button 30. The catheter insertion mechanism 3 is also configured for transferring the medical product from the reservoir 11 to the injection site, via a fluidic chamber 5 and the catheter 32. The catheter insertion mechanism 3 thus belongs to the fluidic module.

[0060] The catheter insertion mechanism 3 may include the button 30, a casing 33 including a top casing 330 and a bottom casing 331 , a fluidic chamber 5, a catheter 32, a needle 34 extending along a longitudinal axis A, a needle holder 35, a septum 36, Figure 9A, biasing means such one or more springs 37, and a sealing member 4 for sealing the catheter 32. The sealing member 4 is configured for maintaining sterility of the catheter insertion mechanism 3 before use. The sealing member 4 is permanently attached to the catheter insertion mechanism 3, and does not have to be removed before use of the injection device 1 .

[0061] The button 30 is configured for activating the injection device 1 , i.e. for deploying the catheter 32 into the injection site. To that end, the button 30 has a pushing surface 31 for axially abutting against the fluidic chamber 5. The button 30 is axially movable along the longitudinal axis A between an initial (deployed) position and an activated (retracted) position. As said earlier, movement of the button 30 is caused by the user, such as the healthcare worker or the patient.

[0062] The needle 34, Figure 6, is configured for pricking the patient’s skin and therefore allowing extension of the catheter 32 through the patient’s skin. The needle 34 may initially extend within the catheter 32. The needle 34 is rigid. For instance, the needle 34 is metallic. The needle 34 may or may not define a fluid passageway for allowing the medical product to flow from the reservoir 11 to the catheter 32. When the needle 34 has a fluid passageway, the needle 34 may remain at least partially inserted inside the catheter 32 after activation. When the needle 34 is a full shank needle, i.e. devoid of any fluid passageway, the needle 34 may retract outside the catheter 32 to allow the medical product to enter the catheter 32. The needle 34 is axially movable together with the needle holder 35 between an initial position, Figure 9A, in which the needle 34 fully extends inside the catheter insertion mechanism 3, a pricking position, Figure 9B, distally located with respect to the initial position, in which the needle 34 is deployed outside the catheter insertion mechanism 3 to penetrate into the injection site, and a post-activated position (not shown), proximally located with respect to the pricking position, in which the needle 34 is retracted back inside the catheter insertion mechanism 3. Movement of the needle 34 and needle holder 35 in the distal direction is caused by the user pressing the button 30. Movement of the needle 34 and needle holder 35 in the opposite direction is caused by the biasing means which may be formed by the two springs 37 lodged in the bottom casing 331 .

[0063] The fluidic chamber 5 has a lateral wall and a distal wall which define an inner cavity 51 , Figure 8, configured for circulation of fluid from the reservoir 11 towards the catheter 32. The septum is placed within the fluidic chamber 5. The fluidic chamber 5 includes an inlet opening 52, Figure 8, allowing entry of the medical product inside the inner cavity. A supporting arm 53 may radially protrude from the inlet opening 52 and may define a recess 530 for receiving and supporting the flexible tube 18 that conveys the medical product from the pump 12 to the inlet opening 52 of the fluidic chamber 5. The supporting arm 53 extends through a camming slot 332, Figure 4, arranged through a lateral wall of the bottom casing. The camming slot 332 prevents rotation of the fluidic chamber 5 when the fluidic chamber 5 is in the initial position. The fluidic chamber 5 also serves to push the needle holder 35 towards the pricking position, and then to release the needle holder 35 so that the needle 34 can retract back inside the catheter insertion mechanism 3. The fluidic chamber 5 supports the catheter 32 and is configured for guiding the medical product coming from the reservoir 11 to a fluid passageway of the catheter 32. The fluidic chamber 5 is axially movable with respect to the bottom casing 331 between an initial position, Figure 9A, in which the catheter 32 extends inside the casing 33, and an activated position, Figure 9B, distally located with respect to the initial position, in which the catheter 32 deploys outside the casing 33 and into the injection site. Movement of the fluidic chamber 5 from the initial position to the activated position is caused by the pushing surface 31 of the button 30 pressing against the fluidic chamber 5 when the button 30 is being depressed to the activated position. Unlike the needle holder 35 and the needle 34, the fluidic chamber 5 stays in the activated position and the catheter 32 stays deployed into the injection site after the activation of the injection device 1 . The catheter 32 may be made of a flexible material.

[0064] The fluidic chamber 5 also includes a detent 54 configured for axially abutting against the needle holder 35 so that movement of the fluidic chamber 5 towards the activated position causes movement of the needle holder 35 towards the pricking position. The fluidic chamber 5 is rotatable with respect to the bottom casing and the needle holder 35 (which cannot rotate), between a blocking position, in which the detent 54 abuts against the needle holder 35, and a release position, in which the detent 54 is away from the axial path of the needle holder 35 so that the needle holder 35 can move back in the proximal direction towards the post-activated position under the pressure of the springs 37. Rotation of the fluidic chamber s at the end of the pricking operation is caused by the camming slot 332 acting on the supporting arm 53 of the fluidic chamber 5.

[0065] More details about the operation of the catheter insertion mechanism 3 are disclosed in the patent document US10737038B2. Figure 7 illustrates the connecting portion 55 of the fluidic chamber 5. The connecting portion 55 is configured for allowing a fixed connection of the sealing member 4 to the fluidic chamber 5. The connecting portion 55 may be in the form of a cylindrical ring which may distally protrude from a distal wall 50 of the fluidic chamber 5, and which may extend around a proximal end of the catheter 32, as illustrated for instance in Figure 9A. The connecting portion 55 includes a distal end 553, a proximal end 554, and a lateral wall 555 extending between the distal end 553 and the proximal end 554, the lateral wall 555 defining an inner conduit for allowing extension of the catheter 32 therethrough. The connecting portion 55 further includes a sealing surface 550 arranged on the lateral wall 555 of the connecting portion 55 for engaging a complementary sealing surface 43 of the sealing member 4, and a fastener 551 which may also be arranged on the lateral wall 555 of the connecting portion 55 for allowing attachment of the sealing member 4 to the fluidic chamber 5. The connecting portion 55 and the fluidic chamber 5 may be made of a single piece.

[0066] The sealing surface 550 permits to seal the outlet of the fluidic chamber 5, and thus the outlet of the fluidic module of the injection device 1 . The sealing surface 550 is configured for radially abutting against the corresponding sealing surface 43 of the sealing member 4, Figure 9A. The fluidic chamber 5 and the sealing member 4 are thus radially sealed to each other. The sealing surface 550 is the outer surface of the lateral wall 555 of the connecting portion 55, the sealing surface 550 being for instance cylindrical and extending all around the longitudinal axis A.

[0067] The fastener 551 is configured for engaging a complementarily shaped fastener 47, Figure 9A, of the sealing member 4 in order to provide a fixed mechanical connection between the sealing member 4 and the fluidic chamber 5. The fastener 551 of the fluidic chamber 5 may be in the form of a circumferential groove extending all around the longitudinal axis A. The may optionally be filled with a glue material. The circumferential groove may be V-shaped to provide both a mechanical attachment and a sealing effect. The circumferential groove or fastener 551 is arranged through the outer surface of the lateral wall, thereby dividing the sealing surface 550 into two annular sealing surfaces 550a, 550b, above and below the fastener 551. The connecting portion 55 may include one or more, such as for instance two fasteners 551 , although embodiments are not limited thereto.

[0068] With reference to Figures 10-11 , the sealing member 4 is arranged at the end of the fluidic module, i.e. downstream of the fluidic path, for maintaining sterility of the catheter insertion mechanism 3 before use. The sealing member 4 is fixedly attached to the fluidic chamber 5. That is, the sealing member 4 is not configured to be removed before use of the injection device 1 . The sealing member 4 may be in the form of a closed flexible sheath including a proximal end 40 fixedly attached to the connecting portion 55 of the fluidic chamber 5, a closed distal end 46, a lateral wall 44 delimiting an inner cavity 440 configured to receive the catheter 32, and a single opening 41 for receiving the connecting portion 55 that holds the catheter 32.

[0069] The sealing member 4 is axially deformable between an initial position, Figure 9A, and an activated position, Figure 9B, proximally located with respect to the initial position. In the initial position, the sealing member 4 is configured to keep sterility of the catheter 32. The distal end 46 of the sealing member 4 is distally located with respect to the distal end of the catheter 32, and of the needle 34, so that the catheter 32, and the needle 34, are fully contained within the inner cavity 440. Sterility is preserved. The volume of the inner cavity 440 may be at a maximum; the sealing member 4 fully extends, i.e. is not collapsed. The initial position may be a rest (undeformed) position. In the activated position, the distal end 46 of the sealing member 4 is proximally located with respect to the distal end of the catheter 32, and of the needle 34, such that the catheter 32, and the needle 34 extend through the sealing member 4. Sterility is broken. Although the needle 34 retracts, the catheter 32 stays through the sealing member 4. The volume of the inner cavity 440 may be at a minimum, the sealing member being collapsed. This is the deformed position of the sealing member 4. Deformation of the sealing member 4 from the initial (deployed) position to the activated (collapsed) position is caused by the fluidic chamber 5 moving together with the sealing member 4 to the activated position, the fluidic chamber 5 axially pressing the sealing member 4 against a proximal wall 338 of the casing 33, such that the sealing member 4 is crushed between the casing 33 and the fluidic chamber 5.

[0070] The sealing member 4, as illustrated in Figure 11 , may be made of a single piece, although embodiments are not limited thereto, as will be seen below. The sealing member 4 is made of a flexible material, such as for instance thermoplastic elastomer (TPE), silicone, polyurethane (PU), polyethylene (PE), polystyrene (PS), or any combination thereof. The material is selected to avoid coring by the sharp needle 34. To avoid coring, the thickness of the sealing member may be lower at the proximal end 40 than in the rest of the sealing member 4 so that the sealing member 4 can be easily pierced.

[0071] The sealing member 4 may include some or all of a sealing surface 43 for tightly engaging the connecting portion 55 of the fluidic chamber 5, a fastener 47 for fixedly attaching the sealing member 4 to the connecting portion 55 of the fluidic chamber 5, and a pricking portion 461 configured to be pricked by the needle 34, thereby providing a passage for the catheter 32 through the sealing member 4 when the device 1 is activated. The sealing surface 43 is arranged on an inner side of the lateral wall 44, at or nearly the proximal end 40 of the sealing member 4, for radially abutting the sealing surface 550 of the fluidic chamber 5. Therefore, the sealing surface 43 preserves sterility inside the sealing member 4. The sealing surface 43 may be in the form of a cylindrical ring defining an inner diameter D1 which may be equal to or lower than an outer diameter D2 defined by the sealing surface 550 of the fluidic chamber 5. This creates a tight radial compression exerted by the sealing member 4 on the connecting portion 55 of the fluidic chamber 5.

[0072] The fastener 47 is arranged on an inner surface of the lateral wall 44 of the sealing member 4, preferably at the proximal end 40 thereof, for engaging the complementarily shaped fastener 551 of the fluidic chamber 5. Therefore, the fastener 47 provides an efficient mechanical attachement of the sealing member 4 onto the fluidic chamber 5. The sealing member 4 is not intended to be removed, but is instead intended to be permanently attached to the fluidic chamber 5, including during activation of the device 1 and injection of the medical product.

[0073] The fastener 47 is in the form of a circumferential rib, or lip, which radially inwardly protrudes from the sealing surface 43 of the sealing member 4, thereby separating the sealing surface 43 in two annular portions 43a, 43b, Figures 10-11 . The fastener may be V-shaped, thereby defining a slanted proximal side easing assembly of the sealing member 4 onto the fluidic chamber 5. The fastener 47 may be slightly deformable to pass over the connecting portion 55 until engagement with the fastener 551 of the connecting portion 55. In an alternative embodiment, the fastener 47 of the sealing member 4 may be a circumferential groove while the fastener 551 of the connecting portion 55 may be the circumferential rib or lip. The groove may be filled with a glue material. The fastener 47 and the sealing member 4 may be made of a single piece, although embodiments are not limited thereto. The sealing member 4 includes one or more fasteners 47, such as for instance a single fastener 47 as illustrated in Figure 10 or 11 , or two fasteners 47 as illustrated in Figure 12, the two fasteners 47 being at two separate axial positions and dividing the sealing surface 43 in three annular portions 43a, 43b, 43c. The corresponding connecting portion 55 (not shown) can accordingly include two fasteners 551 , such as two circumferential groove separating the sealing surface 550 into three annular sealing surfaces.

[0074] The pricking portion 461 is arranged at the distal end 46 of the sealing member 4, across the central longitudinal axis A and thus on the axial path of the needle 34 when the needle 34 distally moves to the activated position, such that the pricking portion 461 is pierced by the needle 34 during activation of the injection device 1. As a result, the pricking portion 461 allows for passage of the needle 34 and the cathether 32 through the sealing member 4 when the device 1 is activated. After retraction of the needle 34, the catheter 32 stays in place, still extending via the hole pierced by the needle 34 through the pricking portion 461 . The pricking portion 461 is a pierceable membrane that forms part of the sealing member 4, and which may specifically form the distal end 46 of the sealing member 4. That is, the pricking portion 461 may be made of the same material as the membrane forming the lateral wall 44 of the sealing member 4 and may form a closed distal extension of the lateral wall 44. The lateral wall 44 extends all around the catheter 32 to provide a seling barrier around the catheter 32, thereby preserving the fluid outlet of the catheter insertion mechanism 3 from the outside environment and maintaining sterility of the fluidic module before activation of the device 1 . The lateral wall 44 may taper in the distal direction, and has for instance the shape of a truncated cone. The lateral wall 44 has an annular abutment portion 441 , Figures 9B-10, configured for abutting and being pressed against the casing 33 of the catheter insertion mechanism 3 when the sealing member 4 is moved togetheter with the fluidic chamber 5 in the distal direction upon activation of the device 1. The compression of the lateral wall 44 allows for piercing of the pricking portion 441 by the needle 34 and complete extension of the catheter 32. Due to compression, the lateral wall 44 is configured to ouwtardly radially expand within an inner cavity of the catheter insertion mechanism 3. This inner cavity may be for instance delimited by an annular recess 339, Figures 9A-9B, extending all around the distal opening 336 of the casing 33. To that end, the casing 33 may include a peripheral rim 337 against which the sealing member 4 is compressed, and a radial shoulder 340 that delimits, together with the peripheral rim 337, the annular recess 339 designed to accommodate the folded lateral wall 44 of the sealing member 4. Therefore, the deformation of the sealing member 4 and its lateral wall 4 is controlled. This avoids that the lateral wall 44 hinders penetration of the catheter 32 into the injection site. Risks of improper injection depth are prevented. The lateral wall 44 of the sealing member 4 is thus configured to deform without hindering penetration and proper positioning of the catheter 32 into the injection site. The lateral wall 44 deforms around the pricking portion 461 , but the pricking portion 461 may stay relatively undeformed. In the embodiment illustrated in Figure 10, the membrane forming the lateral wall 11 has a constant width w, and the outer surface of the lateral wall 44 may be smooth, i.e. devoid of any relief such as grooves, ribs, lumps and so on.

[0075] The injection device 1 of the invention thus provides a sealing barrier for the fluidic module. Besides, the sealing barrier, in the form of the flexible sheath 4, does not need to be removed. That is, no action is required. The user just activates the injection device 1 by pressing the activation button. Moreover, sterility is broken when the flexible sheath 4 is pierced by the needle 34, that is immediately before insertion of the catheter 32 into the injection site. As a result, sterility is kept to the end.

[0076] Figures 13-14 illustrate the injection device 1 according to another embodiment. In this embodiment, the injection device 1 includes a holder 403 for improving reliability of the attachment between the sealing member 4 and the fluidic chamber 5. The holder 403 is here configured for inwardly radially compressing the sealing member 4 against the connecting portion 55 of the fluidic chamber 5. 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. It is reminded that 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.

[0077] The holder 403 is arranged around the proximal end 40 of the sealing member 4 and therefore around the connecting portion 55 of the fluidic chamber 5 for radially pressing the proximal end 40 of the sealing member 4 against the connecting portion 55. The holder 403 may be in the form of a ring, preferably a closed ring, including a proximal end 404, a distal end 405, and a cylindrical lateral wall 406. The holder 403 is axially located at the level of the fasteners 47 of the sealing member 4 and of the fluidic chamber 5 to increase their efficiency. The holder 403 here is an outer ring, i.e. extends outside the sealing member 4, so that the sealing member 4 is sandwiched between the holder 403 and the connecting portion 55. The ring defines a proximal opening at its proximal end 404 for allowing passage of the connecting portion 55, and a distal opening at its distal end 405 for allowing mounting around the proximal end 40 of the sealing member 4.

[0078] The holder may include some or all of an abutment 408 for abutting against the fluidic chamber 5 and a pressing surface 409 for pressing the sealing member against the connecting portion 55 of the fluidic chamber 5. The abutment 408 is provided at the proximal end 404 of the holder 403 for axially abutting against a distal abutment of the fluidic chamber 5 formed by the distal wall 50 of the fluidic chamber 5, Figure 14. Therefore, the holder 403 can be properly positioned with respect to the sealing surfaces 43, 550 and the fasteners 47, 551 of the sealing member 4 and of the fluidic chamber 5. The abutment 408 may be in the form of a proximal shoulder arranged on an inner surface of the cylindrical lateral wall 406 and providing both radial and axial abutment against the fluidic chamber 5. The pressing surface 409 is delimited by the inner surface of the cylindrical lateral wall 406 for inwardly radially abutting against the sealing member 4 so that the sealing surface 43 and the fastener 47 of the sealing member 4 are kept pressed against the connecting portion 55 of the fluidic chamber 5. This improves the tightness of the connection between the sealing member 4 and the fluidic chamber 5. The pressing surface 409 may be cylindrical; its axial dimension may be similar to the axial dimension of the connecting portion 55. As illustrated in Figure 14, the pressing surface 309 defines an inner diameter D3 which may be lower or equal to an outer diameter D4 of the portion (proximal end 40) of the sealing member 4 which is intended to be pressed by the holder 403.

[0079] The holder 403 may be made of a single piece of a rigid material, at least more rigid than the sealing member 4, such as a hard plastic (harder than that of the sealing member 4), or even stainless steel. In the present embodiment, the holder 403 and the sealing member 4 are two separate components that are assembled to each other to form the injection device 1 . The device 1 includes one or more, preferably a single holder 403. Figures 15 and 16 illustrate the injection device 1 according to another embodiment. In this embodiment, the injection device includes a holder 403 for improving reliability of the attachment between the sealing member 4 and the fluidic chamber 5. However, the holder 403 here extends inside the sealing member 4 and is actually part of the sealing member 4. The holder 403 is arranged on the inner surface of the lateral wall 44 of the sealing member 4 for radially abutting against the connecting portion 55. More specifically, the holder 403 is provided in a complementarily shaped recess provided between the proximal end 40 and a proximal shoulder 410 of the sealing member 4. Here, the holder 403 directly abuts against the connecting portion 55.

[0080] The holder 403 forms a circumferential ring, such as a closed ring, including a proximal end 404 which may proximally abut against the distal wall 50 of the fluidic chamber 5, a distal end 405 which may distally abut against the proximal shoulder, and a cylindrical lateral wall 406 which may define an inner diameter D3 similar to an inner diameter D5 of the lateral wall 44 so that an inner surface of the holder 403 is continued by the inner surface of the lateral wall 44 of the sealing member 4. The holder 403 is axially located at the proximal end 40 of the sealing member 4 and of the fluidic chamber 5 to increase their efficiency. The holder 403 here is an inner ring, i.e. extends inside the sealing member 4, so that the holder 403 is interposed between the sealing member 4 and the connecting portion 55. The opening delimited by the holder 403 allows extension of the connecting portion 55 therethrough. The holder 403 may include a fastener 47, which may form the fastener 47 of the sealing member 4 and which may thus be similar. The holder 403 also defines the sealing surface 43 of the sealing member 4.

[0081] The holder 403 is fixedly attached to the sealing member 4. For instance, the holder 403 is overmolded. As a result, the holder 403 and the sealing member 4 are made of a single piece, instead of being two separate parts. The holder 403 and the sealing member 4 may be made of two different materials, the holder 403 being of a more rigid material than the rest of the sealing member 4. For instance, the holder 403 comprises thermoplastic elastomer (TPE), silicone, or polyurethane (PU). The device 1 includes one or more holders 403, for instance a single holder 403.

[0082] Figures 17 to 22 illustrate the sealing member 4 of the injection device 1 according to other embodiments. 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. It is reminded that 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.

[0083] The sealing member 4 may be similar to the previously described sealing members 4, except that the sealing member 4 here includes one or more hinges 49 for controlling deformation of the sealing member 4. As a result, the sealing member 4 does not randomly deform and thus does not jeopardize the pricking and injection depths by inserting itself without control between the casing 33 and and the fluidic chamber 5. The hinges 49 may be arranged on the lateral wall 44 of the sealing member 4 and are axially distributed at predetermined intervals onto the lateral wall 44. Preferably, the hinges 49 are realized without any additional component, they are part of the lateral wall 44 of the sealing member 4. The hinges 49 may be the result of the very shape of the lateral wall 44. In the example illustrated in Figures 17-19, the hinges 49 are grooves. In the example of Figures 20-22, the hinges 49 are folds.

[0084] With reference to Figures 17-19, the grooves 49 are provided on the outer surface of the lateral wall 44 of the sealing member 4, and extend circumferentially all around the longitudinal axis A. The pricking portion 461 may be devoid of any groove. With reference to Figures 20-21 , the circumferential folds 49 are formed by axially alternating crests and valleys, i.e. convex folds 491 and concave folds 492, so that the sealing member 4 may have the shape of a bellows. The folds may also circumferentially extend all around the longitudinal axis A. The diameters D61 to D64 defined by the convex folds 491 may be distally decreasing, and so may be the diameters D71 to D73 defined by the concave folds 492. The pricking portion 461 may be devoid of any fold.

[0085] The hinges 49, such as the grooves of the folds, are preferably configured such that only the pricking portion 461 of the sealing member 4 extends through the opening 336 of the casing 33. Meanwhile, the lateral wall 44 of the sealing member 4 can collapse and extend in the recess 339 formed by the casing 33 around the opening 336.

[0086] The operation of the injection device 1 is as follows. The user can use the patch to attach the injection device 1 to the patient’s skin. After attachment of the injection device 1 to the injection site, the user can activate the device 1 . It is contemplated that the sealing member 4 is still attached to the sealing member 4 and has not been withdrawn. Sterility is thus kept until the last moment. The user then presses the activation button 30 in the distal direction. This moves the needle 34 and the catheter 32 to the activated position. As a result, the sealing member 4 collapses and the needle 34 pierces the distal end 46 of the sealing member 4 so that the catheter 32 extends therethrough. Controlled deformation of the sealing member 4 permits to place the catheter 32 at the right injection depth into the injection site. The injection device 1 is activated. The injection may occur later at the predetermined time.

[0087] It is readily understandable from the above description that the injection device 1 of the invention thus provides a sealing barrier for the fluidic module. The sealing barrier, in the form of the flexible sheath 4, does not need to be removed. That is, no action is required and risks are limited that the device 1 be inadvertently activated. 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.

Claims

CLAIMS1. Injection device (1) including: a housing (2) containing a reservoir (11) for storing a predetermined volume of a medical product, a patch (22) arranged on the housing (2) for allowing attachment of the injection device to an injection site, a catheter insertion mechanism (3) including a needle (34), a catheter (32) and a fluidic chamber (5) configured for fluidly connecting the reservoir (11) to the catheter (32), the fluidic chamber (5) being axially movable together with the needle (34) and the catheter (32) between an initial position and an activated position, distally located with respect to the initial position, in which the needle (34) and the catheter (32) are deployed outside the housing (2) in order to penetrate into the injection site, and a sealing member (4), fixedly attached to the catheter insertion mechanism (3) and configured for maintaining sterility before activation of the device (1), the sealing member (4) including a pricking portion (461) configured to be pierced by the needle (34) during movement of the needle (34) and the catheter (32) towards the activated position.

2. Injection device (1) according to the preceding claim, wherein the sealing member (4) includes one or more fasteners (47) configured for complementarily engaging one or more fasteners (551) of the fluidic chamber (5).

3. Injection device (1) according to any of the preceding claims, wherein the sealing member (4) and the fluidic chamber (5) have radially abutting sealing surfaces (43, 550).

4. Injection device (1) according to the preceding claim, wherein the sealing surface (43) of the sealing member (4) defines an inner diameter D1 equal to or lower than an outer diameter D2 of the sealing surface (550) of the fluidic chamber (5).

5. Injection device (1) according to any of the preceding claims, wherein the injection device (1) includes a holder (403) configured for fixedly securing the sealing member (4) to the fluidic chamber (5).

6. Injection device (1) according to the preceding claim, wherein the holder (403) is a circumferential ring surrounding the sealing member (4) such that the sealing member (4) is caught between the holder (403) and the fluidic chamber (5).

7. Injection device (1) according to claim 5 or 6, wherein the holder (403) and the sealing member (4) are two distinct components.

8. Injection device (1) according to claim 5 or 6, wherein the holder (403) is an inner ring which is part of the sealing member (4).

9. Injection device (1) according to any of the preceding claims, wherein the sealing member (4) includes a lateral wall (44) having a constant width.

10. Injection device (1) according to any of the preceding claims 1 -8, wherein the sealing member (4) includes a lateral wall (44) having one or more hinges (49) for controlling deformation of the sealing member (4).

11. Injection device (1) according to the preceding claim, wherein the hinges (49) are grooves arranged on an outer surface of the lateral wall (44) of the sealing member (4).

12. Injection device (1) according to claim 10, wherein the hinges (49) are preshaped folds including convex folds (491) axially alternating with concave folds (492).

13. Injection device (1) according to the preceding claim, wherein an inner diameter defined by the convex folds (491) or, respectively, the concave folds (492), is distally decreasing.

14. Injection device (1) according to any of the preceding claims, wherein the sealing member (4) is configured to deform in an outward radial direction.

15. Injection device (1) according to the preceding claim, wherein the catheter insertion mechanism (3) has an opening (336) allowing passage of the catheter (32) towards theactivated position, and a recess (339) extending around the opening (338) for accommodating the deformed sealing member (4).

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