Injection device including a sealing member, and method for removing said sealing member from the injection device
The present invention relates to a wearable injection device including a sealing member configured for keeping sterility of a catheter insertion mechanism of the injection device, and a method for removing the sealing member from the injection device.
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.
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.
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 kit packaging which also contains the wearable injection device.
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.
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 known from document US2019015585 an ambulatory infusion pump. Document US2022211952 discloses a needle hub for a drug delivery device. Document US2008269692 discloses a manually powered delivery device for injecting a pharmaceutical.
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.
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 fluidic chamber configured for fluidly connecting the reservoir to a catheter, the fluidic chamber being axially movable together with the catheter between an initial position and an activated position, distally located with respect to the initial position, in which the catheter is deployed outside the housing in order to penetrate into the injection site, and a sealing member, removably attached to the fluidic chamber and arranged around the catheter for maintaining sterility, a support, movable between a blocking position, in which the support blocks movement of the fluidic chamber so that the fluidic chamber cannot reach the activated position, and a release position, in which the support no longer prevents the fluidic chamber from reaching the activated position, a remover configured for firstly removing the sealing member from the fluidic chamber and for subsequently displacing the support from the blocking position to the release position.
Therefore, the fluidic chamber is able to move to the activated position only after removal of the sealing member. In other words, the fluidic chamber cannot move to the activated position as long as the sealing member is not removed. The injection device of the invention thus allows for reliable removal of the sealing member without risk of inadvertently or prematurely displacing the fluidic chamber to the activated position. That is, the injection device cannot be activated by merely pulling the sealing member. The injection device of the invention also allows for providing a sterile barrier around the needle and the catheter, i.e. at the outlet port of the fluidic circuit, thanks to the sealing member.
The injection device of the invention may further include some or all of the features listed below.
The sealing member is axially removable.
The remover is a two-stage remover, i.e. removes the sealing member first and then, by further axial movement, removes the support.
The remover is axially movable with respect to the support. The remover and the support are two distinct parts.
The remover is axially movable with respect to the sealing member. The sealing member and the remover are two distinct parts.
In an embodiment, the remover is movable between an initial position, a first removing position, distally located with respect to the initial position, in which the remover engages the sealing member in order to remove the sealing member from the fluidic chamber, and a second removing position, distally located with respect to the first removing position, in which the remover engages the support in order to remover the support from the injection device.
In an embodiment, the remover includes a first distal abutment surface configured for abutting against a proximal abutment surface of the sealing member, and a second distal abutment surface configured for abutting against a proximal abutment surface of the support.
In an embodiment, in the initial position of the remover, the first distal abutment surface of the remover and the proximal abutment surface of the sealing member are separated by a distance d1 , and the second distal abutment surface of the remover and the proximal abutment surface of the support are separated by a distance d2 greater than d1 .
In an embodiment, the sealing member and the fluidic chamber have radial sealing surfaces radially abutting against each other.
In an embodiment, the support includes a stop member extending outside a catheter insertion mechanism of the injection device.
In an embodiment, the stop member is configured for abutting against the fluidic chamber, preferably against a supporting arm of the fluidic chamber.
The stop member may directly abut against the supporting arm of the fluidic chamber.
In an embodiment, the support includes a stop member extending inside a catheter insertion mechanism of the injection device.
In an embodiment, the stop member is configured for abutting against a needle holder arranged in the catheter insertion mechanism for holding a needle. The stop member may directly abut against the needle holder, and thus indirectly abut against the fluidic chamber.
In an embodiment, the stop member is configured for abutting against the fluidic chamber, preferably against a distal wall of the fluidic chamber.
The stop member may directly abut against the distal wall of the fluidic chamber.
In an embodiment, the support includes a locking element, the locking element being resiliently deformable between a locking position, in which the locking element prevents removal of the support from the catheter insertion mechanism, and a release position, in which the locking element allows removal of the support from the catheter insertion mechanism.
In an embodiment, the remover includes a radial abutment wall configured for radially abutting against the locking element of the support when the remover is in the initial position, such that the locking element is maintained in its locking position by the remover as long as the remover stays in the initial position.
In an embodiment, the patch includes an adhesive layer and a liner, the liner being secured to the support.
Therefore, withdrawal of the support from the injection device causes withdrawal of the liner from the adhesive layer.
The liner is configured for protecting the adhesive layer before use of the injection device.
Another aspect of the invention is a method for removing the sealing member of the above-described injection device, the method including the following steps:
(i) in a first stage, removing the sealing member from the fluidic chamber of the injection device;
(ii) in a second stage, moving the support from the blocking position to the release position.
The second stage occurs after completion of the first stage. That is, the support moves to the release position (and therefore releases the fluidic chamber) only when the sealing member is detached from the fluidic chamber.
In an embodiment, the step of removing the sealing member and the step of moving the support to the release position are performed by the same action of pulling the remover in the distal direction.
That is, the user just needs to pull the remover to remove the sealing member first, and then to remove the support. This two-stage removal is thus accomplished in a single action, which is continuously pulling the remover away from the injection device.
Possibly, the step of moving the support to the release position may include removal of a liner of the patch from an adhesive layer of the patch. That is, removal of the support entails automatic and simultaneous removal of the liner. The user does not have to perform two different consecutive actions.
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 1 is a perspective view of an injection device according to an embodiment of the invention, in an initial (unactivated) state,
Figure 2 is a perspective view of an injection device according to an embodiment of the invention, in an activated state,
Figure 3 is an exploded view of an injection device according to an embodiment of the invention,
Figure 4 is a perspective of a catheter insertion mechanism of an injection device according to an embodiment of the invention,
Figure 5 is an exploded view of a catheter insertion mechanism of an injection device according to an embodiment of the invention,
Figures 6-8 are perspective views illustrating a fluidic chamber of the catheter insertion mechanism of an injection device according to an embodiment of the invention,
Figure 9A is a perspective view of a sealing cap of a catheter insertion mechanism of an injection device according to an embodiment of the invention,
Figure 9B is a cross section view of a sealing cap of a catheter insertion mechanism of an injection device according to an embodiment of the invention,
Figures 10A and 10B are cross-section views of a catheter insertion mechanism of an injection device according to an embodiment of the invention, respectively in an initial position and an activated position,
Figure 11 is a perspective view of a catheter insertion mechanism of an injection device according to an embodiment of the invention,
Figure 12 is a perspective view of a base of an injection device according to an embodiment of the invention,
Figures 13-14 are perspective views of a support of an injection device according to an embodiment of the invention,
Figures 15-16 are perspective views of a remover of an injection device according to an embodiment of the invention,
Figures 17A-17D are cross-section views illustrating removal of the sealing cap of a catheter insertion mechanism of an injection device according to an embodiment of the invention, Figures 18-19 are perspective views of a catheter insertion mechanism of an injection device according to an embodiment of the invention,
Figure 20 is a perspective view of a base of an injection device according to an embodiment of the invention,
Figure 21 is a perspective view of a support of an injection device according to an embodiment of the invention,
Figures 22A-22D are cross-section views illustrating removal of the sealing cap of a catheter insertion mechanism of an injection device according to an embodiment of the invention,
Figure 23 is a perspective view of a catheter insertion mechanism of an injection device according to an embodiment of the invention,
Figure 24 is a perspective view of a support of an injection device according to an embodiment of the invention,
Figure 25 is a cross-section view of a support of an injection device according to an embodiment of the invention,
Figure 26 is a perspective view of a remover of an injection device according to an embodiment of the invention,
Figures 27A-27D are cross-section views illustrating removal of the sealing cap of a catheter insertion mechanism of an injection device according to an embodiment of the invention,
Figures 28-29 are a cross-section views illustrating an injection device according to an embodiment of the invention,
Figure 30 is an exploded view of an injection device according to an embodiment of the invention,
Figure 31 is a bottom perspective view of an injection device 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 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 .
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 fludily 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.
The injection device 1 may be divided into a connectable electonic module and a fluidic module which are 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).
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.
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.
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 10A, 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 axially removable and has to be removed before use of the injection device 1 , as will be explained in further details below.
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.
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 10A, in which the needle 34 fully extends inside the catheter insertion mechanism 3, a pricking position, distally located with respect to the initial position (not shown), in which the needle 34 is deployed outside the catheter insertion mechanism 3 to penetrate into the injection site, and a post-activated position, Figure 10B, 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 .
The fluidic chamber 5 has a lateral wall and a distal wall which define an inner cavity 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 10A, in which the catheter 32 extends inside the casing 33, and an activated position, Figure 10B, 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.
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.
More details about the operation of the catheter insertion mechanism 3 are disclosed in the patent document US10737038B2.
As illustrated in Figure 7, the fluidic chamber 5 has a connecting portion 55. The connecting portion 55 is configured for allowing connection of the removable sealing member 4 to the fluidic chamber 5. The connecting portion 55 may distally protrude from a distal wall 50 of the fluidic chamber 5, and may extend around a proximal end of the catheter 32, as illustrated in Figure 6. The connecting portion 55 defines an inner conduit for allowing extension of the catheter 32 therethrough, and a sealing surface 550 arranged on a lateral wall of the connecting portion 55 for engaging a complementary sealing surface 43 of the sealing member 4. An annular groove 551 may be arranged between the sealing surface 550 and the distal end of the fluidic chamber 5 to permit attachment of the sealing member 4 to the fluidic chamber 5. The annuar groove 551 may or may not receive a complementarily shaped attachment member, such as a circular rib (not shown), of the sealing member 4.
With reference to Figures 9A, 9B is shown the sealing member 4. The sealing member 4 is arranged at the end of the fluidic module, i.e. downstream of the fluidic path, to keep sterility of the fluidic module, and more specifically of the catheter insertion mechanism, until use of the injection device 1. The sealing member 4 is configured to be axially removed from the injection device 1 .
The sealing member 4 may be in the form of a rigid, or flexible, or semi-rigid, cap configured for closing the fluidic chamber 5 all around the catheter 32. The cap thus defines an inner cavity adapted to receive the catheter 32. An opening 41 is arranged at a proximal end 40 of the cap to allow insertion of the catheter 32 and of the connecting portion 55 of the fluidic chamber 5 within the inner cavity. This opening 41 may be the sole opening of the cap which is otherwised closed to maintain sterility. The proximal end 40 of the cap defines a proximal stop 42 extending around the opening 41 and configured for axially abutting against the distal wall 50 of the fluidic chamber 5 in order to stop assembly of the cap to the connecting portion 55. The cap is received within the casing 33 and is thus configured to be inserted through a distal opening 336, Figure 10A, of the bottom casing 331 . The cap may distally taper, and may have a frustoconical shape. The cap may be made of a single piece of a plastic material, such as for instance thermoplastic elastomer (TPE), silicone, polyurethane (PU).
The cap includes an inner sealing surface 43 delimited by a lateral wall 44 of the cap and configured for engaging the corresponding sealing surface 550 of the fluidic chamber 5. The proximal stop 42 advantageously stops insertion of the cap at a predetermined axial position in which the sealing surfaces 43, 550 engage each other. Here, since removal of the cap is axial, the cap and the fluidic chamber 5 achieve a radial sealing due to the radial abutment of their respective sealing surfaces 43, 550. Therefore, the cap and the connecting portion 55 here have radial sealing surfaces 43, 550. The cap may be held due to friction between the cap and the connecting portion 55, for instance at their sealing surfaces. For instance, the cap may be slightly deformable at its proximal end 40 and the inner diameter of cap may be lower at its proximal end than the outer diameter of the connecting portion 55, so as to achieve a radial compression at the sealing surfaces 43, 550. The cap may otherwise include an attachment member such as a snap feature (not shown) configured for engaging the corresponding attachment member, such as the annular groove 551 of the connecting portion 55.
The cap is removably attached to the fluidic chamber 5, and is axially detachable from the fluidic chamber 5. In order to allow removal of the cap, an annular rib 45 may be arranged at an outer surface of the lateral wall 44 of the cap for axially receiving a distal abutment surface 604 of the remover 6. The annular rib 45 defines a corresponding proximal abutment surface 450 allowing for application of a distal force upon the cap so that the cap can be detached from the connecting portion 55 of the fluidic chamber 5. The annular rib 45 may extend all around or partially around the cap. The abutment surface 450 may be orthogonal to the longitudinal axis A. The annular rib 45 may be arranged at a distal end 46 or at an intermediate portion of the cap, between its proximal and distal ends 40, 46 and preferably closer to the distal end 46 than the proximal end 40 so that the remover 6 can easily access the annular rib 45. Besides, the annular rib 45 may be located such that the annular rib 45 does not hinder insertion of the cap within the casing 33 of the catheter insertion mechanism 3. Specifically, the annular rib 45 may define an outer diameter D1 that is lower or equal to the greatest outer diameter of the cap, and more specifically the outer diameter D2 of the cap at its proximal end 40. The annular rib 45 may further include, opposite the abutment surface 450, a slanted wall 451 that eases passage of the remover 6 over the annular rib 45 when the remover 6 is being mounted onto the cap.
It is important to notice that removal of the cap here cannot inadvertently cause movement of the fluidic chamber 5 towards the activated position, as will be explained below.
Figures 11-17D illustrate a catheter insertion mechanism 3, a base, a support 7 and a remover 6 according to a first embodiment of the injection device 1 of the invention.
With reference to Figure 12 is shown a portion of the base 21 of the injection device 1. The base 21 has a through-opening 210 allowing passage of the catheter 32 and the needle 34. The through-opening 210 also permits insertion of the cap inside the catheter insertion mechanism 3 so that the cap can be attached to the fluidic chamber 5. The through-opening 210 also permits insertion of at least a grasping portion 60 of the remover 6 configured for engaging the cap. The through-opening 210 may also be configured to allow extension of a stop member 70 of the support 7. Here, the through-opening 210 has a radial slot 211 for allowing insertion and withdrawal of a stop member 70 of the support 7. The radial slot 21 1 and the stop member 70 are complementarily shaped. The radial slot 211 helps position the base 21 with respect to the support 7 and prevents relative rotation between the base 21 and the support 7.
Figure 13 illustrates the support 7. The support 7 is configured for preventing inadvertent activation of the injection device 1 when the cap is removed from the connecting portion 55 of the fluidic chamber 5. The support 7 is removably attached to the base 21 of the injection device 1 , and is axially movable with respect to the base 21 between a blocking position, Figure 17A, in which the support 7 blocks axial movement of the fluidic chamber 5 or the needle holder 35 towards the activated or pricking position, thereby preventing inadvertent activation of the injection device 1 , and a release position, Figure 17D, in which the support 7 is removed from the base 21 so that the support 7 no longer blocks axial movement of the fluidic chamber 5 or needle holder 35 from the initial position to the activated or pricking position. Axial movement of the support 7 from the blocking position to the release position is caused by the remover 6 abutting against the support 7 when the user pulls the remover 6 in the distal direction. The support 7 includes a stand 72, a connector 74, and a stop member 70. The support 7 may be made of a single piece.
As illustrated in Figures 13-14, the stand 72 is configured for supporting the connector 74 and the stop member 70. The stand 72 may also be configured for axially abutting against a distal (bottom) face 212 of the base 21 so as to properly position the support 7 with respect to the base 21 . The plate-shaped stand 72 extends parallel and distal to the base 21 . The stand 72 includes a proximal (top) face 720 configured for abutting against the base 21 of injection device 1 in the blocking position, a distal (bottom) face 721 and a through-opening 722 for allowing passage of the remover 6. The through-openings 210, 722 of the stand 72 and the base 21 may be coaxially arranged.
With reference to Figure 13, the stop member 70 is configured for axially abutting against the fluidic chamber 5 in order to axially block the fluidic chamber 5 in the initial position. As long as the support 7 is in the blocking position, the injection device 1 thus cannot be activated. The stop member 70 is also configured for extending through the base 21 . The stop member 70 may be in the form of an axially extending rib which proximally protrudes from the stand 72, orthogonal to the proximal face 720 of the stand 72. The stop member 70 includes a distal end 700 secured to the stand 72 and an opposite proximal end 703. The stop member 70 may be located next to the through-opening 722 of the stand 72, and next to the camming slot 322 when assembled to the injection device 1 . The stop member 70 further includes a proximal abutment surface 701 configured for axially abutting against the fluidic chamber 5, and more specifically against the supporting arm 53 of the fluidic chamber 5. Here, the stop member 70 accordingly extends outside the casing 33 of the catheter insertion mechanism 3. The axially extending rib may have a proximally decreasing height hi , thereby defining a slanted edge 704 which favors insertion of the stop member 70 through the base. The stop member 70 may include a reinforcing rib 702, also proximally protruding from the proximal face 720 of the stand 72, and arranged perpendicular to the axially extending rib 70, such that the proximal end 701 of the stop member 70 is T-shaped. The support 7 includes one or more stop members 70, for example a single one as illustrated in Figure 13, although embodiments are not limited thereto.
Figure 14 illustrates the connector 74 of the support 7. The connector 74 is configured for receiving the remover 6, and more specifically a sliding portion 64 of the remover 6, and for guiding axial movement of the remover 6 with respect to the support 7. As illustrated in Figures 13-14, the connector 74 may be in the form of a cylindrical tube, distally protruding from a distal face 721 of the stand 72 and extending around the through-opening 722 of the stand 72. The connector 74 has an opened distal end 740 allowing insertion of the remover 6, a lateral wall 742 defining an inner cavity designed to receive the pulling portion 62 of the remover 6 and a proximal end 743 secured to the stand 72. The proximal end 743 defines a proximal opening which is coincident with the through-opening of the stand 72. The distal end 740 may define a distal stop 741 for axially abutting against the remover 6 and therefore stopping insertion of the remover 6 into the support 7. An inner peripheral ring 744 may inwardly radially protrude from the lateral wall 742 inside the inner cavity. This inner ring 744 may define a guiding member 745 for guiding axial movement of the remover 6 relative to the support 7, and a proximal stop 746 for stopping distal movement of the remover 6, thereby allowing the remover 6 to exert a distal pulling force on the support 7. The inner ring 744 may be closer to the distal end 740 of the connector 74 than its proximal end 743. The guiding member 745 may be in the form of a U- shaped notch provided through the inner ring 744. The notch has an opened distal end and an opened proximal end, and allows for insertion of the remover 6 in the connector 74 according to a predetermined rotational position of the remover 6 with respect to the support 7. The notch also defines two orthoradial abutment surfaces 747 that prevent rotation of the remover 6 relative to the support 7, and that axially guide the remover 6 within the support 7. The connector 74 may include one or more guiding members 745, such as for instance two diametrically opposite guiding members 745, although embodiments are not limited thereto. As above-mentioned, the proximal stop 746 is configured for axially abutting against the remover 6. Orthogonal to the longitudinal axis A, the proximal stop 746 may be defined by a proximal side of the inner ring 744, for instance next to the U-shaped notch, between the U-shaped notch and the lateral wall 742. The connector 74 includes one or more, such as two diametrically opposite proximal stops 746, although embodiments are not limited thereto. Now turning to Figures 15-16 is shown the remover 6. The remover 6 is configured for axially detaching the sealing member 4 from the fluidic chamber 5 and for axially removing the support 7 from the base 21 of the injection device 1 . The remover 6 accomplishes a two-step removal: first the sealing member 4, then the support 7. This permits to withdraw the sealing member 4 while the support 7 still blocks the fluidic chamber 5, thereby preventing activation of the injection during removal of the sealing member 4. The remover 6 may, or may not, be axially movable with respect to the sealing member 4 between an initial position, Figure 17A, in which the abutment surface 604 of the remover 6 does not engage the abutment surface 450 of the sealing member 4 and in which the abutment surfaces 450, 604 may thus be axially distant, and a first removing position, Figure 17B, distally located with respect to the initial position, in which the abutment surfaces 450, 604 of the sealing cap 4 and the remover 6 abut against each other, so that further distal movement of the remover 6 entails detachment of the sealing member 4 from the catheter insertion mechanism 3. Movement of the remover 6 from the initial position to the first removing position is caused by the user pulling the remover 6 in the distal direction. The remover 6 is axially movable with respect to the support 7 between an initial position, Figure 17A, in which the remover 6 does not engage the support 7 such that a distal abutment surface 645 of the remover 6 is axially away from the proximal abutment surface 746 of the support 7 and in which the remover 6 may proximally abut against the distal stop 741 of the connector 74, and a second removing position (or release position), Figure 17C, distally located with respect to the initial position and, if appropriate, to the first removing position, in which the remover 6 engages the support 7 so that further distal movement of the remover 6 entails withdrawal of the support 7 from the injection device 1 . Movement of the remover 6 from the initial position to the second removing position is caused by the user pulling the remover 6 in the distal direction. As visible in Figure 15, the remover 6 may include some or all of a carrier portion 66, a pulling portion 62, a sliding portion 64 and a grasping portion 60. The remover 6 is preferably made of a single piece. In an embodiment (not shown), the remover 6 and the sealing member 4 may be made of a single piece.
Still with reference to Figures 15-16, the carrier portion 66 is configured for supporting the pulling portion 62 and the sliding portion 64. The carrier portion 66 may be in the form of a T-shaped plate extending orthogonal to the longitudinal axis A. The carrier portion 66 includes a proximal side 660, a distal side 661 , a basement 662 supporting the sliding portion 64, and two C-shaped supporting arms 663 laterally extending from the basement 662 in order to support the pulling portion 62.
The pulling portion 62 is configured for being grasped and distally pulled out by the user so that the remover 6 detaches the sealing member 4 and the support 7 from the injection device 1 , just before placement of the injection device 1 onto the patient’s skin. As illustrated in Figures 15-16, the pulling portion 62 may be in the form of a pulling ring 620 defining an opening allowing passage of a user’s finger. The pulling portion 62 includes two connecting arms 622 that extend parallel to each other and which define a U-shaped recess for accommodating the basement 662 of the carrier portion 66. The basement 662 and the pulling portion 62 thus delimit a U-shaped slot 624 allowing movement of the pulling portion 62 with respect to the carrier portion 66. At one end, the connecting arms 622 are secured to the pulling ring 620 while their opposite end is secured to the supporting arms 663 of the carrier portion 66 by means of a hinge 625 configured for allowing rotation of the pulling portion 62 with respect to the carrier portion 66. The hinge has a thinner width than the width of the supporting arms 663 and/or the connecting arms 622, and may be delimited by one or two opposite radial grooves 626 which extend perpendicular to the central longitudinal axis A. That is, the hinges 625 longitudinally extend perpendicular to the central longitudinal axis A so that the pulling ring 620, when pulled by the user, is axially aligned with the longitudinal axis A. It is contemplated that the connecting arms 663 have a stop surface 664 configured to stop rotation of the pulling ring by radially abutting against a corresponding stop surface 623 defined at one end of the supporting arms 663 of the carrier portion 66. The hinges 625 may be axially located closer to a proximal side of the pulling portion 62 and the carrier portion 66 than to their distal side so as to increase the area of the stop surface 664. The pulling portion 62 is thus rotationally movable with respect to the carrier portion 66 between a storing position, Figures 15-16, in which the pulling ring 620 may extend orthogonal to the longitudinal axis A, and a pulling position (not shown), in which the pulling ring 620 may vertically extend along, parallel to the longitduinal axis A. In the pulling position, the pulling ring 620 is thus axially aligned with the sliding portion 64 and the grasping portion 60 so that the effort exerted by the user on the pulling portion 62 is efficiently transmitted to the sliding portion 64 and the grasping portion 60, and therefore to the support 7 and to the sealing member 4. Rotation of the pulling portion 62 from the storing position to the pulling portion 62 is caused by the user.
The sliding portion 64 is configured to slide within the connector 74 of the support 7 and to remove the support 7 from the injection device 1 when the pulling portion 62 of the remover 6 is pulled by the user. The sliding portion 64 may have a cylindrical wall 640 extending around the longitudinal axis A between a distal end secured to the carrier portion 66 and an opposite proximal end carrying the grasping portion 60. The sliding portion 64 thus proximally protrudes from the proximal side of the basement 624 of the carrier portion 66. The sliding portion 64 includes a resilient leg 642 which may define a sliding surface 643 configured for radially abutting against a corresponding sliding surface 748 arranged at the bottom of the notch of the support 7 for axially guiding the remover 6 within the support 7, two orthoradial abutment surfaces 644 configured for orthoradially abutting against the corresponding orthoradial abutment surfaces 747 of the support 7 to prevent relative rotation between the remover 6 and the support 7, and a distal abutment surface 645. The resilient leg 642 may axially extend between a distal end secured to the cylindrical wall 640 and a free proximal end provided with an outward radial protrusion whose proximal side defines the distal abutment surface 645 and whose proximal side may define a slanted wall 648 that eases passage of the resilient leg 642 over the inner ring 744 of the support 7. The cylindrical wall 640 may include a window 641 for allowing inward deformation of the resilient leg 642 when the remover 6 is assembled to the support 7, i.e. when the sliding portion 64 of the remover 6 is inserted into the connector 74 of the support 7. The resilient leg 642 is radially movable, more specifically deformable, between a blocking (rest) position, Figure 17A, in which the distal abutment surface 645 of the remover 6 can axially face the proximal abutment surface 746 of the support 7, and a mounting (deformed) position, inwardly radially located with respect to the blocking position, allowing insertion of the sliding portion 64 of the remover 6 into the connector 74 of the support 7. Movement of the resilient leg 642 from the blocking (rest) position to the mounting (deformed) position is caused by the slanted wall 648 abutting against the inner ring 744 of the support 7 and by the application of a proximal force on the remover 6 so that the remover 6 goes into the support 7. The distal abutment surface 645 of the resilient leg 642 is configured for axially abutting against the proximal abutment surface 746 of the support 7 when the remover 6 is in the second removing (release) position, such that further displacement of the remover 6 in the distal direction causes removal of the support 7 from the base 21 of the injection device 1 . The sliding portion 64 includes one or more, preferably two diametrically opposite resilient legs 742, although embodiments are not limited thereto.
The grasping portion 60 is configured for moving the sealing member 4 in the distal direction when the remover 6 is pulled by the user. Therefore, the sealing member 4 is withdrawn from the catheter insertion mechanism 3. The grasping portion 60 is designed to pass through the through-openings 210, 722 of the support 7 and of the base 21 and to penetrate inside the casing 33 of the catheter insertion mechanism 3 to be able to engage the sealing member 4. The grasping portion 60 includes one or more, preferably two diametrically opposite and axially extending legs 600 having a distal end connected to a proximal end of the sliding portion 64 and a proximal end provided with a grasper 603 which may be in the form of an inwardly radially extending protrusion defining a distal abutment surface 604 configured to axially abut against the peripheral ring 45 of the sealing member 4. The axially extending legs 600 may be resilient so as to radially outwardly deform in order to pass over the peripheral ring 45 of the sealing member 4 when the remover 6 is assembled to the injection device 1. The axially extending legs 600 delimit between them a recess 605 configured to at least partially accommodate the sealing member 4. As illustrated in the Figures 15-16, the graspers 603 of the grasping portion 60 and the protrusions of the legs 642 the sliding portion 64 may be arranged in the same longitudinal plane. The remover 6 includes two graspers 603, although embodiments are not limited thereto. Instead of distal abutment surfaces 604, the graspers 603 could include teeth for pricking into the sealing member 4, friction surfaces for radially abutting against the sealing member 4, or any other means for distally moving the sealing cap 4 together with the remover 6 when the remover
6 is pulled away from the injection device 1 by the user.
With reference to Figures 17A-17D, a method for removing the sealing member 4 of an injection device 1 according to the embodiment of Figures 11 -16 is detailed below.
Figure 17A illustrates the injection device 1 before use. The sealing member 4 is attached to the connecting portion 55 of the fluidic chamber 5. The support 7 is against the base; the stop member 70 is in the blocking position. The remover 6 is in the initial position: the distal abutment surface 604 of the grasper 603 axially faces the proximal abutment surface 450 of the sealing member 4, while the distal abutment surface 645 of the sliding portion 64 axially faces the proximal abutment surface 746 of the support 7. The axial distance d1 between the distal abutment surface 604 of the grasper 603 and the proximal abutment surface 450 of the sealing member 4 is lower than the axial distance d2 between the distal abutment surface 645 of the sliding portion 64 and the proximal abutment surface 746 of the support 7. The pulling ring 620 is in the storing position.
The user, such as for instance the nurse, may first move the pulling ring 620 to the pulling position (not shown). By means of the pulling portion 62, the user pulls the remover 6 in the distal direction. As a result, the remover 6 axially moves relative to the support 7 and to the sealing member 4 until the remover 6 distally abuts against the sealing member 4 (Figure 17B). The distal abutment surface 645 of the sliding portion 64 may still be axially away from the proximal abutment surface 746 of the support 7. At this stage, further distal movement of the remover 6 causes the remover 6 to exert a distal force on the sealing member 4 such that the sealing member 4 is removed from the fluidic chamber 5. The fluidic chamber 5 cannot move towards the activated position because the support 7 has not moved yet and the stop member 70 accordingly blocks axial movement of the fluidic chamber 5. The injection device 1 thus cannot be activated as long as the sealing member 4 is not fully removed.
When or after the sealing member 4 is fully removed and thus no longer contacts the fluidic chamber 5, the distal abutment surface 645 of the remover 6 axially abuts against the support 7 (Figure 17C). The support 7 is ready to be removed. To that end, the remover 6 is further moved away from the base 21 such that the remover 6 exerts a distal force on the support 7, which slides relative to the base 21 from the blocking position to the release position (Figure 17D), until complete removal of the support 7. The remover 6, the sealing member 4 and the support 7 can be discarded by the user. The fluidic chamber 5 is no longer blocked by the support
7 and is thus able to move towards the activated position upon activation of the injection device 1 by the user. The user first attaches the injection device 1 to the patient’s skin and presses the activation button 30, so that the catheter 32 can penetrate into the injection site as previously described.
The injection device 1 of the invention thus allows axial removal of the sealing member 4 without risk that the injection device 1 be activated, because the support 7 blocks any distal movement of the fluidic chamber 5 as long as the sealing member 4 is not removed. This two-stage removal prevents inadvertent activation of the injection.
Figures 18-22D illustrate a catheter insertion mechanism 3, a base, a support 7 and a remover 6 according to a second embodiment of the injection device 1 of the invention.
The second embodiment essentially differs from the first embodiment in that the stop member 70 of the support 7 is in the form of an axial rod, Figure 21 , and in that the axial rod extends within the casing 33 of the catheter insertion mechanism 3 to axially block the needle holder 35 and thereby axially block the fluidic chamber 5 wich axially abuts against the needle holder 35 via the detents 54. That is, the stop member 70 here extends inside the catheter insertion mechanism 3, instead of extending outside, and axially blocks the needle holder 35, instead of directly blocking the fluidic chamber 5.
Figure 19 illustrates the bottom casing of the catheter insertion mechanism 3. The bottom casing 331 is configured to receive the stop member 70 of the support 7 and allow axial removal of the support 7 when the user pulls the remover 6 away. To that end, the bottom casing includes a hole 334 configured for allowing passage of the stop member 70. The hole 334 and the stop member 70 may be complementarily shaped. The hole 334 is located at a distal surface 333 of the bottom casing 331 , and more specifically at a distal end of a barrel 335 of the bottom casing 331 , the barrel 335 being shaped to receive the spring 37. The hole 334 is axially aligned with the spring 37 and axially faces a boss 350 of the needle holder 35, Figure 22A, the boss 350 allowing to capture the spring 37.
With reference to Figure 20 is shown a portion of the base 21 of the injection device 1 . Here, the through-opening 210 still has a radial slot 211 for allowing insertion and withdrawal of the stop member 70 of the support 7. The radial slot 211 and the stop member 70 are complementarily shaped. The radial slot 211 prevents relative rotation between the base 21 and the support 7. The base 21 may include as many radial slots 211 as stop members 70, for instance two diametrically opposite radial slots 211 as illustrated in Figure 20. The base 21 further includes a snap-fit member 213 for removably attaching the support 7 to the base. The snap-fit member 213 may include an opening configured to be engaged by a corresponding snap-fit member 723 of the stand 72 of support 7, such as a hook, Figure 21 . It is contemplated that the snap-fit member 213 is not limited to this embodiment and may also be included, although not illustrated, in the base 21 and the support 7 of the first embodiment. The base 21 and the support 7 may include one or more snap-fit members 213, 723, such as four, although this number may vary.
Figure 21 illustrates the support 7. The support 7 is axially movable with respect to the base 21 between a blocking position, Figure 22A, in which the proximal abutment surface 701 of the support 7 can axially abut against the needle holder 35 to block distal movement of the needle holder 35 together with the fluidic chamber 5, and a release position, Figure 22D, in which the support 7 is removed from the base 21 so that the support 7 no longer blocks axial movement of the needle holder 35. As illustrated in Figure 21 , the stop member 70 is in the form of a straight axial rod extending parallel to the central longitudinal axis A. The axial rod has a proximal end secured to the stand 72 and distal end which defines the proximal abutment surface 701 . The axial rod is aligned with the boss 350 and the barrel 335, and extends inside the spring 37. The proximal abutment surface 701 is configured for axially abutting against a distal end of the boss 350. The proximal end of the support member 70 may be X-shaped, the axial rod here including four reinforcing ribs regularly distributed around an axial direction parallel to the axis A. The support 7 includes one or more, for example two diametrically opposite stop members 70, although embodiments are not limited thereto.
The other features of the injection device 1 according to the second embodiment, such as for instance the connector 74 of the support 7 and the remover 6, may be similar to those previously described in connection with the first embodiment. 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.
With reference to Figures 22-22D, a method for removing the sealing member 4 of an injection device 1 according to the embodiment of Figures 18-21 is detailed below.
Figure 22A illustrates the injection device 1 before use. The sealing member 4 is attached to the connecting portion 55 of the fluidic chamber 5. The support 7 is against the base; the stop member 70 is in the blocking position. The remover 6 is in the initial position: the distal abutment surface 604 of the grasper 603 axially faces the proximal abutment surface 450 of the sealing member 4, while the distal abutment surface 645 of the sliding portion 64 axially faces the proximal abutment surface 746 of the support 7. The axial distance d1 between the distal abutment surface 604 of the grasper 603 and the proximal abutment surface 450 of the sealing member 4 is lower than the axial distance d2 between the distal abutment surface 645 of the sliding portion 64 and the proximal abutment surface 746 of the support 7. The pulling ring 620 is in the storing position.
The user, such as for instance the nurse, may first move the pulling ring 620 to the pulling position (not shown). By means of the pulling portion 62, the user pulls the remover 6 in the distal direction. As a result, the remover 6 axially moves relative to the support 7 and to the sealing member 4 until the remover 6 distally abuts against the sealing member 4 (Figure 22B). The distal abutment surface 645 of the sliding portion 64 may still be axially away from the proximal abutment surface 746 of the support 7. At this stage, further distal movement of the remover 6 causes the remover 6 to exert a distal force on the sealing member 4 such that the sealing member 4 is removed from the fluidic chamber 5. The fluidic chamber 5 cannot move towards the activated position because the support 7 has not moved yet and the stop member 70 indirectly blocks axial movement of the fluidic chamber 5 by abutting against the needle holder 35. The injection device 1 thus cannot be activated as long as the sealing member 4 is not fully removed.
When or after the sealing member 4 is fully removed and thus no longer contacts the fluidic chamber 5, the distal abutment surface 645 of the remover 6 axially abuts against the support 7 (Figure 22C). The support 7 is ready to be removed. To that end, the remover 6 is further moved away from the base 21 such that the remover 6 exerts a distal force on the support 7, which slides relative to the base 21 from the blocking position to the release position (Figure 22D), until complete removal of the support 7. The remover 6, the sealing member 4 and the support 7 can be discarded by the user. The fluidic chamber 5 is no longer blocked by the support 7 and is thus able to move towards the activated position upon activation of the injection device 1 by the user. The user first attaches the injection device 1 to the patient’s skin and then presses the activation button 30, so that the catheter 32 can penetrate into the injection site as previously described.
The injection device 1 of the invention thus allows axial removal of the sealing member 4 without risk that the injection device 1 be activated, because the support 7 blocks any distal movement of the fluidic chamber 5 as long as the sealing member 4 is not removed. This two-stage removal prevents inadvertent activation of the injection.
Figures 23-27D illustrate a catheter insertion mechanism 3, a base, a support 7 and a remover 6 according to a third embodiment of the injection device 1 of the invention. Here, like in the second embodiment, the support 7 extends within the casing 33 of the catheter insertion mechanism 3, instead of extending outside. However, like in the first embodiment, the support 7 is here configured to axially abut against the fluidic chamber 5, instead of axially abutting against the needle holder 35.
The base 21 of the injection device 1 has not been illustrated since the base 21 is similar to the base 21 of the first or second embodiment, still having a through-opening 210 allowing insertion of the sealing member 4, the grasping portion 60 of the remover 6, and extension of the stop member 70 of the support 7 in a complementarily shaped manner. The base 21 may however be devoid of the radial slots 211 shown in Figures 12-20 and/or devoid of snap-fit members 213. Figure 24 illustrates the support 7. The support 7 may be here removably attached to the catheter insertion mechanism 3, instead of being attached to the base 21 of the injection device 1 , and is axially movable with respect to the catheter insertion mechanism 3 between a blocking position, Figure 27A, in which the support 7 blocks axial movement of the fluidic chamber 5 towards the activated position, thereby preventing inadvertent activation of the injection device 1 , and a release position, Figure 27D, in which the support 7 is removed from the base 21 so that the support 7 no longer blocks axial movement of the fluidic chamber 5 from the initial position to the activated or pricking position. The support 7 includes a stand 72, a connector 74, and a stop member 70. The support 7 may be made of a single piece.
As illustrated in Figure 24, the stand 72 is configured for supporting the connector 74 and the stop member 70. The stand 72 is similar to the stand 72 of the first or second embodiment, except that the stand 72 may here includes two radial ears extending on opposite sides of the through-opening 722.
Still with reference to Figure 24, the stop member 70 may be in the form of a cylindrical tube extending around the longitudinal axis A. The cylindrical tube defines an inner cavity configured for receiving the sealing member 4, Figure 27A, and the grasping portion 60 of the remover 6. The cylindrical tube extends inside the casing 33 of the catheter insertion mechanism 3. The cylindrical tube proximally protrudes from the stand 72, its distal end surrounding the through-opening 722 of the stand 72 and its opposite proximal end defining the proximal abutment surface 701 configured for axially abutting against the distal wall 50 of the fluidic chamber 5. The stop member 70 here includes a locking element 705 configured for locking the support 7 in the blocking position inside the casing 33 of the catheter insertion mechanism 3. More specifically, the locking element 705 is configured for axially abutting against a proximal stop 337 of the bottom casing 331 , Figure 27A, for preventing withdrawal of the support 7 from the catheter insertion mechanism 3. The proximal stop 337 may be defined as a peripheral surface that surrounds the distal opening 336 of the bottom casing 331. The locking element 705 is in the form of a resilient tab axially extending in an opening 710 of the cylindrical tube, from a proximal end secured to the cylindrical tube to a free distal end which defines a distal stop 706 for axially abutting against the proximal stop 337 of the casing 33. The tab may have a curved or bended shape such that a distal portion 707 of the tab is outwardly inclined with respect to a proximal portion 708 of the tab. The tab is resiliently deformable between a release (rest) position, schematically illustrated in Figure 25, in which the distal stop 706 does not axially face the proximal stop 337 to allow axial movement, and accordingly insertion or removal, of the support 7 with respect to the catheter insertion mechanism 3, and a locking (deformed) position, Figure 27A, in which the tab outwardly extends with respect to the release position so that the distal stop 706 axially faces the proximal stop 337 and therefore prevents removal of the support 7 from the catheter insertion mechanism 3. Inward movement from the locking (deformed) position to the release (rest) position is due to the tab resiliency, whereas outward movement from the release (rest) position to the locking (deformed) position is due to insertion of the remover 6 inside the cylindrical tube that forms the stop member 70. The remover 6 indeed radially abuts against an inner face 709 of the locking element, thereby radially outwardly pushing the locking element 705 to its locking position. Therefore, the locking element 705 is maintained in the locking position (and the fluidic chamber 5 is accordingly axially blocked) as long as the grasping portion 60 of the remover 6 is inside the catheter insertion mechanism 3. The stop member 70 includes one or more, such as for instance two diametrically opposite locking elements 705, although embodiments are not limited thereto.
Figure 24 also illustrates the connector 74 of the support 7. The connector 74 is configured for axially guiding the sliding portion 64 of the remover 6. The connector 74 here includes a guiding member 745 in the form of a distal leg that axially protrudes from the distal face 721 of the stand 72. The distal leg has a proximal end secured to the stand 72 and a free distal end provided with a radially inward protrusion which delimits, on a proximal side, the proximal stop 746 of the connector 74 for axially abutting against the remover 6 and, on a distal side, an inclined wall easing assembly of the remover 6 onto the support 7. The guiding member is configured for engaging a complementarily shaped guiding member 647 of the remover 6, such as an opening. The connector 74 includes one or more, such as for example two diametrically opposite distal legs, although embodiments are not limited thereto.
Now turning to Figure 26 is shown the remover 6. The remover 6 may be axially movable between an initial position, Figure 27A, in which the distal abutment surface 604 of the remover 6 does not engage the proximal abutment surface 450 of the sealing member 4, a first removing position, Figure 27B, distally located with respect to the initial position, in which the distal abutment surface 604 of the remover 6 and the proximal abutment surface 450 of the sealing member 4 abut against each other, and a second removing position (or release position), Figures 27C-27D, distally located with respect to the first removing position, in which the remover 6 abuts against the support 7 so that further distal movement of the remover 6 entails withdrawal of the support 7 from the injection device 1. As visible in Figure 26, the remover 6 may include some or all of a carrier portion 66, a pulling portion 62, a sliding portion 64 and a grasping portion 60.
The carrier portion 66 may be a plate-shaped disc, orthogonal to the longitudinal axis A, and supporting the pulling portion 62 and the grasping portion 60. The distal face 661 of the carrier portion 66 defines the distal abutment surface 645 for axially abutting against the proximal abutment surface 746 of the support 7. The sliding portion 64 is here formed by the carrier portion 66 which includes two openings 647 provided through the circular disc for receiving the guiding members 745 of the support 7. The pulling portion 62 includes two diametrically opposite radial legs. A recess 627 is arranged on a proximal side of the radial legs to accommodate a user’s finger. A reinforcing rib 628 is arranged on a distal side of the radial legs to prevent against deformation when the user pulls the remover 6 in the distal direction. The pulling portion 62 may here be fixed with respect to the carrier portion 66. It is contemplated that the pulling portion 62 of the embodiment illustrated in Figure 26 may alternatively be similar to the pulling portion 62 shown in the previously described embodiments, such as for instance the embodiment illustrated in Figure 15. The grasping portion 60 too may be similar to the grasping portion 60 of the first or second embodiment. It should be noted that the grasping portion 60 includes a radial abutment wall 606 configured for radially abutting against the locking member 705 of the support 7 such that the grasping portion 60 maintains the locking element 705 in the locking (deformed) position. The radial wall 606 may delimited by an axial rib 607 protruding from an axially extending leg of the remover 6. The height h2 of the axial rib 607 may proximally decrease, so that withdrawal of the remover 6 results in a decreasing pressure exerted by the axial rib 607 on the locking element 705, thereby allowing the locking element 705 to move to the release (rest) position as the remover 6 is being withdrawn from the injection device 1 .
The other features of the injection device 1 according to the third embodiment may be similar to those previously described in connection with the first or the second embodiment. 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.
With reference to Figures 27A-27D, a method for removing the sealing member 4 of an injection device 1 according to the embodiment of Figures 23-26 is detailed below.
Figure 27A illustrates the injection device 1 before use. The sealing member 4 is attached to the connecting portion 55 of the fluidic chamber 5. The stop member 70 is in the blocking position. The remover 6 is in the initial position: the distal abutment surface 604 of the grasper 606 axially faces the proximal abutment surface 450 of the sealing member 4, while the distal abutment surface 645 of the carrier portion 66 axially faces the proximal abutment surface 746of the support 7. The axial distance d1 between the distal abutment surface 604 of the grasper 603 and the proximal abutment surface 450 of the sealing member 4 is lower than the axial distance d2 between the distal abutment surface 645 of the sliding/carrier portion 64, 66 and the proximal abutment surface 746 of the support 7.
The user, such as for instance the nurse, pulls the remover 6 in the distal direction. As a result, the remover 6 axially moves relative to the support 7 and to the sealing member 4 until the remover 6 distally abuts against the sealing member 4 (Figure 27B). The distal abutment surface 645 of the carrier portion 66 may still be axially away from the proximal abutment surface 746 of the support 7. At this stage, further distal movement of the remover 6 causes the remover 6 to exert a distal force on the sealing member 4 such that the sealing member 4 is removed from the fluidic chamber 5. The fluidic chamber 5 cannot move towards the activated position because the support 7 has not moved yet and the stop member 70 accordingly blocks axial movement of the fluidic chamber 5. The injection device 1 thus cannot be activated as long as the sealing member 4 is not fully removed.
When or after the sealing member 4 is fully removed and thus no longer contacts the fluidic chamber 5, the distal abutment surface 645 of the remover 6 axially abuts against the support 7 (Figure 27C). The grasping portion 60 no longer abuts against the locking element 705 of the support 7, such that the locking element 705 can return to its release (rest) position as illustrated in Figure 25. The distal stop 706 of the support 7 is thus shifted away from the proximal stop 337 of the casing 33. The support 7 is ready to be removed. To that end, the remover 6 is further moved away from the base 21 such that the remover 6 exerts a distal force on the support 7, which slides from the blocking position to the release position (Figure 27D), until complete removal of the support 7. The remover 6, the sealing member 4 and the support 7 can be discarded by the user. The fluidic chamber 5 is no longer blocked by the support 7 and is thus able to move towards the activated position upon activation of the injection device 1 by the user. The user first attaches the injection device 1 to the patient’s skin and presses the activation button 30, so that the catheter 32 can penetrate into the injection site as previously described.
The injection device 1 of the invention thus allows axial removal of the sealing member 4 without risk that the injection device 1 be activated, because the support 7 blocks any distal movement of the fluidic chamber 5 as long as the sealing member 4 is not removed. This two-stage removal prevents inadvertent activation of the injection.
With reference to Figure 28-29, the patch 22 of the injection device 1 includes an adhesive layer 220 and a removable liner 221 for protecting the adhesive layer 220. The patch 22 may be glued or welded to the base 21 of the injection device 1 . The patch 22 extends between the base 21 and the proximal side 720 of the stand 72 of the support 7. The adhesive layer 220 may be fixed with respect to the base 21 , while the liner 221 may be attached to the support 7 by means of a first attachment member 725, Figure 30. As a result, when the user removes the support 7 from the base, the support 7 automatically peels off the liner 221 .
With reference to Figures 30-31 , the first attachment member 725 may be arranged in a recess 726 provided on the distal face 721 of the stand 72 of the support 7, and may be in the form of a strip including a first portion 727 secured to the support 7 and a second portion 728 secured to the liner 221 , for example glued or heat-sealed, or mechanically anchored, to the liner. The support 7 may include a second attachment member 729 configured for securing the strip to the support 7. The second attachement member 729 may be a closing flap rotatably mounted with respect to the support 7 between an open position, Figure 25, and a closing position (not shown) in which the closing flap extends over the strip to maintain the strip fixed against the support 7. Snap-fitting means, such as hooks 730 and corresponding openings 731 , may be arranged on the flap and the support 7 to secure the flap in the closing position. The injection device 1 may include one or more, for example two first attachment members 725 and two second attachment members 729, although embodiments are not limited thereto. The features illustrated in Figures 28-31 may be included in any of the three above embodiments, in order to ease removal of the liner, without need for the user to manually peels the liner off.
It is readily understandable from the above description that the injection device 1 of the invention allows for removal of a sealing member 4, which maintains sterility of the catheter insertion mechanism and thus of the fluidic module, without risk that the injection device 1 be 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.