Medical device comprising an injection system and a protective element

Abstract

The present invention relates to a medical device (10) comprising a housing (14) having a wall (16) traversed by an opening (18); an injection system (20) comprising an injection element (22) and an activation system (30) for moving the injection element along an axis of deployment (X1) between a retracted position and a deployed position; and a protective element (50), comprising at least one retaining element (56), which is removably joined to the injection system when the injection element is in its retracted position. The protective element and the activation system form between them a closed inner space (V50), in which a free end (24) of the injection element is arranged. In addition, a free end (54) of the protective element extends out of the housing and the at least one retaining element of the protective element opposes movement of the injection element along the axis of deployment.

Description

[0001] TITLE: MEDICAL DEVICE COMPRISING AN INJECTION SYSTEM AND AN

[0002] PROTECTIVE ELEMENT

[0003] The present invention relates to a medical device, in particular a medical device for delivering medicinal fluid by parenteral injection. The invention specifically addresses a medical device comprising a system for activating an injection element for delivering a medicinal fluid to a patient.

[0004] The treatment of certain conditions, such as some cancers, requires the continuous injection of medicinal fluid over a relatively long period. This is particularly true for treatments involving large volumes of medicinal fluids containing active ingredients of biological origin, which may also have high viscosity. Slow, continuous injection is then necessary, especially to avoid causing pain to the patient, and is most often performed in a hospital setting.

[0005] To make life easier for patients, the use of portable injection devices is particularly beneficial. These devices can be attached to a patient's skin, for example with an adhesive patch, and allow for the automatic injection of the medication. This enables patients to take their medication independently at home, thus minimizing the impact of injection time on their daily activities.

[0006] In these portable injection devices, an injection element, such as a needle or cannula, is used to inject a medicinal fluid through a patient's skin. To maintain the sterility of the injection element and / or minimize the risk of injury from it, a removable cap may be provided around it. Before using the device, the patient removes the cap to expose the injection element.

[0007] It is known that the injection element is coupled to an activation system that allows it to move from an initial position, retracted within the device housing, to an injection position, deployed from the device housing. The patient attaches the device to a part of their body before activating the activation system of the injection element, which then pierces the patient's skin. The medicinal fluid can then be injected into the patient through the injection element.

[0008] However, with such systems, a shock, for example from the device being dropped, could cause the injection element to deploy unexpectedly into its injection configuration, risking injury to the patient or anyone handling the device. To minimize any risk, efforts are therefore being made to stabilize this activation system, particularly to prevent the unwanted deployment of the injection element.

[0009] The aim of the invention is therefore to propose an improved medical device, in which the unexpected deployment of the injection element in the deployed position, and more generally the displacement of the injection element along a deployment axis, is prevented, without complicating the use of the medical device.

[0010] To this end, the invention relates to a medical device comprising: a housing, having a wall through which an opening passes, an injection system, comprising: o an injection element, having a free end, and o an activation system, disposed in the housing, coupled to the injection element and configured to move the injection element along a deployment axis so as to drive the injection element between at least:

[0011] ■ a retracted position, and

[0012] ■ a deployed position in which the injection element extends through the opening so that the free end of the injection element extends outside the housing, a protective element, comprising at least one retaining element, the protective element being capable of being removably assembled onto the injection system at least when the injection element is in its retracted position.

[0013] When the injection element is in the retracted position and the protection element is assembled on the injection system: the protection element and the activation system together form a closed internal volume, in which the free end of the injection element is disposed, a free end of the protection element extends outside the housing, and at least one retaining element of the protection element opposes a displacement of the injection element along the deployment axis, in particular in a deployment direction of the injection element, from its retracted position to its deployed position and / or in a retraction direction of the injection element.

[0014] Thanks to the invention, at least one retaining element of the protective element prevents the injection element from moving along its deployment axis, thus reducing the risk of unexpected deployment of the injection element and malfunction of the injection system. The protective element also protects the injection element when the medical device is not in use. Furthermore, when the medical device needs to be used, the protective element can be easily removed by acting on its free end, simultaneously exposing the injection element and removing the obstacle to its movement.

[0015] According to other advantageous aspects of the invention, the medical device comprises one or more of the following features, taken individually or in all technically possible combinations:

[0016] - At least one retaining element of the protective element is in contact with the wall of the housing when the injection element is in the retracted position and the protective element is assembled on the injection system, so that at least one retaining element cooperates with the wall of the housing to oppose the movement of the injection element along the deployment axis.

[0017] - At least one retaining element includes a retaining surface bearing against an edge of the opening when the injection element is in the retracted position and the protective element is assembled on the injection system, so that the retaining surface cooperates with the edge of the opening to oppose a displacement of the injection element along the deployment axis as well as, preferably, in a direction perpendicular to the deployment axis.

[0018] - At least one retaining element comprises an internal support element, bearing against an internal surface of the housing wall when the injection element is in the retracted position and the protective element is assembled on the injection system, such that the internal support element cooperates with the internal surface of the housing wall to resist the movement of the injection element along its deployment axis in a deployment direction. Preferably, the internal support element projects beyond the rest of the protective element.

[0019] - At least one retaining element comprises an external support element, bearing against an external surface of the housing wall when the injection element is in the retracted position and the protective element is assembled on the injection system, such that the external support element cooperates with the external surface of the housing wall to oppose displacement of the injection element along the deployment axis in a direction of retraction of the injection element. Preferably, the external support element projects beyond the rest of the protective element.

[0020] - At least one retaining element of the protective element includes at least one support element extending beyond the rest of the protective element.

[0021] - The protective element is suitable for being removably assembled onto the activation system, in particular by fitting or clipping.

[0022] - The activation system includes a support extending along the deployment axis, surrounding a part of the injection element, in particular in a circumferential direction to the deployment axis, the injection element is coupled to the support and, when the injection element is in the retracted position and the protection element is assembled on the injection system, the protection element is fitted onto the support.

[0023] - When the injection element is in the retracted position and the protective element is assembled on the injection system, one retaining end of the protective element is against the injection system along the deployment axis.

[0024] - When the injection element is in the retracted position and the protection element is assembled on the injection system, the retaining end of the protection element is against the activation system along the deployment axis.

[0025] - The retaining end of the protective element forms a continuous surface around the injection element, in a circumferential direction to the deployment axis, and at least 50% of the continuous surface is abutting the injection system.

[0026] - The entire protective element is capable of passing through the opening.

[0027] - The protective element is a single piece.

[0028] - The protective element includes an inner portion, disposed inside the housing and forming, with the activation system, the closed inner volume when the injection element is in the retracted position and the protective element is assembled on the injection system, the free end of the protective element is connected to the inner portion of the protective element by a foldable link and the foldable link is, preferably, a hinge, a pivot or a ball joint.

[0029] - When the injection element is in the retracted position and the protective element is assembled on the injection system, the free end of the protective element allows the protective element to be removed from the housing.

[0030] - The medical device is a device for delivering medicinal fluid by parenteral injection, for example a portable or non-portable device.

[0031] - The medical device is a device for delivering medicinal fluid by parenteral injection, the injection being carried out automatically by the medical device.

[0032] The invention will become clearer upon reading the following description, given solely by way of non-limiting example, and made with reference to the drawings in which:

[0033] [Fig. 1] Figure 1 is a perspective view of a medical device conforming to a first embodiment of the invention, equipped with its protective element.

[0034] [Fig. 2] Figure 2 is a view analogous to that of Figure 1, representing the same medical device, without its protective element. [Fig. 3] Figure 3 is a cross-section of the medical device of Figure 1, along plane III of Figure 1.

[0035] [Fig. 4] Figure 4 is a cross-section similar to Figure 3, representing the medical device without its protective element and with the injection element in its deployed position.

[0036] [Fig. 5] Figure 5 is a view analogous to Figure 1, representing a medical device according to a second embodiment of the invention, equipped with its protective element.

[0037] [Fig. 6] Figure 6 is a side view of the protective element of the medical device in Figure 5.

[0038] [Fig. 7] Figure 7 is a cross-section similar to Figure 3, representing a medical device according to a third embodiment of the invention, equipped with its protective element.

[0039] [Fig. 8] Figure 8 is a side view of the protective element of the medical device in Figure 7.

[0040] A medical device 10 according to the invention is shown in Figures 1 to 4. The medical device 10 allows the injection of a medicinal fluid into or under a target layer. The target layer is, for example, the skin of a patient. In this example, the medical device 10 is a medical device for delivering medicinal fluid by parenteral injection. The medical device 10 is used, for example, to allow the injection of medicinal fluid into a patient by subcutaneous, intradermal, or intramuscular injection.

[0041] Regardless of the embodiment considered, the medical device according to the invention can notably be used to administer a medicinal fluid to a patient in order to treat a wide variety of pathologies such as, for example, autoimmune diseases or chronic diseases such as diabetes or associated disorders, cancers, hormonal deficiencies, macular degeneration, inflammations, atherosclerosis, rheumatoid arthritis, coronary syndromes, thromboembolic diseases, and all diseases whose treatment requires the slow and continuous administration of a medicinal fluid by parenteral route, etc.

[0042] Thus, the term "medicinal fluid" refers to any liquid formulation suitable for continuous administration via, for example, a hollow needle or cannula. The formulation may be a solution, a gel, or a fine suspension containing one or more active ingredients.These active ingredients may include peptides (for example, insulin or GLP-1, their derivatives or analogues, amylin or its derivatives or analogues, gastric inhibitory peptides or their analogues), proteins, glycoproteins, or hormones (for example, hormones originating from the pituitary gland or hypothalamus, such as gonadotropins or gonadotropin-releasing hormone or GnRH, desmopressin, gonadorelin, triptorelin, terlipressin, leuprorelin, buserelin, goserelin, nafarelin, lutropin, menotropin, follicle-stimulating hormone or FSH and its analogues, follitropin, parathyroid hormone, teriparatide, abaloparatide or other parathyroid hormone analogues, calcitonin, growth hormone, etc.). somatropin, etc.), active ingredients derived from hormones or nucleotides (e.g., DNA, RNA, or oligonucleotides), enzymes, polysaccharides (e.g., glycosaminoglycans, hyaluronic acids, heparins, low molecular weight heparins and their derivatives, or sulfated or polysulfated forms of these polysaccharides), vaccines, antibodies and their analogues (e.g., denosumab, panitumumab), nutritional substances. Formulations may contain these active ingredients in the form of any pharmaceutically acceptable salt or solvate, as well as any necessary and appropriate excipient.

[0043] The medical device 10 includes a patch 12, which allows it to be attached to the target layer. The patch 12 is, for example, an adhesive patch. The patch 12 is, for example, covered with a film. Before using the medical device 10, a user removes the film to expose the patch, specifically an adhesive surface of the patch, thus allowing the medical device 10 to be attached to the target layer.

[0044] The medical device 10 comprises a housing 14, which defines an internal compartment V14 and includes a wall 16 to which the patch 12 is attached, for example, by being glued. Thus, when the medical device 10 is placed on the target layer, the wall 16 is positioned opposite the target layer, with the patch 12 extending between the target layer and the wall 16. Furthermore, the wall 16 and the patch 12 are traversed by an opening 18, which is thus located opposite the target layer. The opening 18 therefore leads into the housing 14, more precisely into the internal compartment V14.

[0045] The medical device 10 includes an injection system 20, which is at least partially housed within the casing 14. The injection system 20 comprises an injection element 22, which, in this example, is a cannula. In a variant of the invention not shown, the injection element 22 is a needle. The use of a cannula as the injection element 20 is particularly advantageous in the case of a portable medical device.

[0046] The injection element 22 has a free end 24.

[0047] The injection element 22 is mobile, at least in translation, along a deployment axis X1, between at least one retracted position and one deployed position. A deployment direction is defined as a direction, along the deployment axis X1, corresponding to a movement of the injection element from its retracted position to its deployed position. A retraction direction is defined as a direction opposite to the deployment direction, along the deployment axis X1, corresponding to a movement of the injection element from its deployed position to its retracted position.

[0048] In its retracted position, as illustrated in Figure 3, the injection element 22 extends primarily within the internal compartment V14. In other words, the majority of the injection element 22 extends within the internal compartment. For example, at least 80% of the length of the injection element 22 extends within the internal compartment. Furthermore, in its retracted position, the free end 24 of the injection element 22 is, for example, located within the housing 14, i.e., within the internal compartment V14.

[0049] In the example, in the retracted position, the entire injection element 22 extends into the housing 14. In other words, in the retracted position, the injection element 22 does not protrude outside the housing 14.

[0050] In the deployed position, as illustrated in Figure 4, the injection element 22 extends through the opening 18 so that its free end 24 extends outside the housing 14. In the example, the injection element 22 is mobile only in translation along the deployment axis X1.

[0051] Thus, when the injection element 22 is in the deployed position, the free end 24 of the injection element 22 extends outside the housing 14, beyond the opening 18. When the medical device 10 is placed on the target layer, the free end 24 of the injection element 22 then extends into the target layer, allowing the injection of a medicinal fluid into or under the target layer. Conversely, in the retracted position of the injection element 22, the injection of a medicinal fluid into the target layer is not possible.

[0052] The injection system 20 also includes an activation system 30, located in the housing 14, i.e., in the internal compartment V14, and coupled with the injection element 22 so as to allow the injection element 22 to be moved along the deployment axis X1 between its retracted and deployed positions. In other words, the injection element 22 is moved by the activation system 30. Specifically, the activation system 30 enables the injection element 22 to move from its retracted position to its deployed position.

[0053] In the embodiment shown in Figures 1 to 4, the activation system 30 comprises a support 32, to which the injection element 22 is coupled. In other words, the injection element is carried by the support 32.

[0054] The support 32 includes a guide portion 34, which has an internal volume V34 in fluidic communication with the injection element 22 and connected to a conduit, thus allowing the flow of medicinal fluid from a reservoir (not shown) to the injection element 22 via the internal volume V34 of the guide portion. Furthermore, the support 32, and more specifically the guide portion 34, extends along the deployment axis X1, surrounding a portion of the length of the injection element 22. In other words, the support 32, and more specifically the guide portion 34, surrounds a portion of the injection element 22 in a circumferential direction around the deployment axis X1.

[0055] As seen in Figure 4, the injection element 22 is fixed to the guide portion 34. The injection element 22 is thus fixed in motion to the guide portion 34. A fixing end 25 of the injection element 22 is fixed to the guide portion 34 so as to open into the internal volume V34.

[0056] In the embodiment shown in figures 1 to 4, the support 32 also includes a first drive element 36 and a second drive element 38.

[0057] The first drive element 36 is attached to the guidance portion 34 so that a translation of the first drive element 36 along the deployment axis X1 results in an identical translation of the guidance portion 34.

[0058] The second drive element 38 is mounted on the first drive element 36 so that a relative translational movement between the two drive elements along the deployment axis X1 is permitted. A spring 39 is mounted between the first and second drive elements.

[0059] Furthermore, the support 32 includes a reversible fastening element, not shown, which allows the second drive element 38 to be reversibly fixed to the first drive element 36. Before use of the medical device 10, particularly in the configuration of Figure 3, the second drive element 38 is fixed to the first drive element 36 by this reversible fastening element.

[0060] In addition, and optionally, an insertion element 43 is attached to the second drive element 38 and extends along the deployment axis X1 coaxially with the injection element 22. When the injection element 22 is in the retracted position, the insertion element 43 extends at least partially inside the injection element 22, at least as far as the free end 24 of the injection element 22. The insertion element 43 is preferably a needle. The insertion element 43 facilitates the insertion of the injection element 22 into the target layer, as explained below. The insertion element 43 is particularly advantageous when the injection element 22 is a flexible cannula.

[0061] In the embodiment shown in Figures 1 to 4, the activation system 30 also includes an actuating arm 40, which extends along an actuating axis X2 parallel to the deployment axis X1. The actuating arm 40 is mounted in the housing 14 so as to be rotatable about the actuating axis X2. A motor, not shown, is coupled to the actuating arm 40 so as to drive the actuating arm in rotation about the actuating axis X2. Alternatively, the actuating arm 40 is driven in rotation about the actuating axis X2 by another means, for example, by a manual actuator. The actuating arm 40 supports the first drive element 36 and the second drive element 38.Advantageously, the housing 14 includes guide elements, not shown in the figures, which guide the translation of the first drive element 36 and the second drive element 38 along the deployment axis X1.

[0062] In addition, the actuating arm 40 is coupled to the first drive element 36 via a spring 41, so that a rotational movement of the actuating arm 40 around the actuating axis X2 releases a stop between the actuating arm 40 and the first drive element 36, which causes a translational movement of the first drive element 36 parallel to the deployment axis X1.

[0063] The medical device 10 includes, for example, a control element not shown, the activation of which enables the injection of a medicinal fluid by the medical device 10 to be actuated. The control element is in particular capable of controlling the motor driving the actuating arm 40.

[0064] When the control element is activated, the motor is actuation, causing the actuating arm 40 to rotate in a first direction around the actuating axis X2. The rotation of the actuating arm 40 causes the support 32, specifically the first drive element 36 and the second drive element 38, to translate under the effect of the spring 41 along the deployment axis X1, in the deployment direction, thus moving the injection element 22 from its retracted position to its deployed position. The translation of the second drive element 38 is driven by the first drive element 36, to which the second drive element 38 is secured by the reversible locking element.

[0065] During the transition from the retracted to the deployed position of the injection element 22, and when the medical device 10 is in place on the target layer, the free end 24 of the injection element 22 penetrates the target layer. This penetration is facilitated by the insertion element 43, which is disposed at least partially inside the injection element 22, extending at least to the free end 24 and thus stiffening the injection element 22. When the injection element 22 reaches its deployed position, the reversible locking element between the first drive element 36 and the second drive element 38 is detached, thereby separating the second drive element 38 from the first drive element 36.Next, under the action of spring 39, the second drive element 38 is moved away from the first drive element 36, in a translational movement along the deployment axis X1 in the retraction direction, causing the insertion element 43 to be withdrawn from inside the injection element 22, so that the insertion element 43 does not impede the flow of the medicinal fluid through the injection element 22. When the medical device 10 is placed on the target layer, the insertion element 43 is also withdrawn from the target layer as it is withdrawn from the injection element 22. The injection element 22 is then held in its deployed position by the support 32 and the first drive element 36. The free end 24 of the injection element 22 then remains outside the housing 14.When the medical device 10 is placed on the target layer, the free end 24 of the injection element 22 remains in the target layer to allow the injection of the medicinal fluid. This configuration of the medical device 10 is shown in Figure 4.

[0066] For example, a piston (not shown) is actuated to draw the flow of medicinal fluid from the reservoir into the conduit, to the internal volume V34 of the guide portion 34, and then to the injection element 22. This piston is, for example, actuated by the same motor that drives the actuating arm 40, by a dedicated motor, or by another actuating device. Alternatively, the flow of medicinal fluid to the injection element 22 is driven by other means, such as by a pump or by pressurizing the reservoir containing the medicinal fluid.

[0067] As can be seen in Figure 3, the injection element 22 and the guide portion 34 are arranged in cantilever of the actuating arm 40, i.e. the deployment axis X1 is offset relative to the actuating axis X2 at which the actuating arm is mounted on the housing 14. The medical device 10 includes a protective element 50, which is shown assembled on the injection system 20 in Figures 1 and 3 and removed from the injection system 20 in Figures 2 and 4.

[0068] The protective element 50 isolates the injection element 22 when it is in the retracted position, particularly before the medical device 10 is installed on the target layer, notably to ensure the sterility of the injection element 22 before its use and / or to limit the risk of injury related to the injection element 22. Thus, the protective element 50 ensures the protection of the injection element 22 from the assembly of the device until the use of the medical device 10 and in particular during the transport and handling of the medical device 10.

[0069] For this purpose, the protective element 50 is removably mounted on the injection system 20, at least when the injection element 22 is in its retracted position. It is intended to be removed from the injection system before the medical device 10 is used, for example, before the medical device 10 is installed on the target layer.

[0070] When installed on the injection system 20, the protective element 50 extends along a main axis X50, shown in Figure 3, coinciding with the deployment axis X1.

[0071] Thus, when the injection element 22 is in the retracted position and the protective element 50 is assembled onto the injection system 20, the protective element 50 and the activation system 30 together form a closed internal volume V50, in which the free end 24 of the injection element 22 is located. More precisely, the protective element 50 has an internal portion 52 which is located in the housing 14, i.e., in the internal compartment V14, and which extends along the deployment axis X1, forming, with the activation system 30, the closed internal volume V50 in which the free end 24 of the injection element 22 is located. In other words, the inner portion 52 of the protection element 50 and the activation system 30 form a continuous envelope around the free end 24 of the injection element 22, in a circumferential direction to the deployment axis X1, and in the deployment direction.The inner portion 52 of the protective element 50 has a cylindrical or slightly conical shape extending along the principal axis X50 around the injection element 22, which has a circular, oval, or ovoid cross-section. The inner portion 52 extends at least to the level of the opening 18, along the deployment axis X1. The inner portion 52 includes a cavity into which at least the free end 24 of the injection element 22, and in particular the entire injection element 22, is housed. The opening 18 is circular, oval, or ovoid in shape.

[0072] Advantageously, the inner portion 52 is removably assembled on the activation system 30, and even more advantageously on the guiding portion 34. In other words, the protective element 50 is reversibly attached to the activation system 30.

[0073] In the embodiment shown in Figures 1 to 4, a retaining end 52A of the inner portion 52 is fitted onto the support 32, more precisely onto the guide portion 34. This press-fit assembly is particularly advantageous for ensuring a seal between the guide portion 34 and the protective element 50, such that the guide portion 34 and the protective element 50 form a closed internal volume V50, in which the free end 24 of the injection element 22 is disposed. The preservation of the sterility of the free end 24 of the injection element 22 is thus ensured by the protective element 50 assembled onto the activation system 30. The press-fit assembly is achieved by elastic deformation of the retaining end 52A around the guide portion 34 and therefore involves clamping. For example, this assembly is done by hand, or using an assembly machine.

[0074] In a non-represented variant of the invention, the inner portion 52, more specifically its retaining end 52A, is removably assembled on the activation system 30, advantageously on the guiding portion 34, by means other than a fitting, for example by clipping.

[0075] The inner portion 52 of the protective element 50, together with the activation system on which it is mounted, forms a sterile envelope around the free end 24 of the injection element 22. A "sterile envelope" is defined as an envelope capable of maintaining the level of sterility required for the injection systems of medical devices. In other words, the closed inner volume V50 formed by the protective element 50 and the activation system 30, particularly the guiding portion 34 of the activation system 30, is sterile, thus protecting the free end 24 of the injection element 22.

[0076] The protective element 50 also includes a free end 54, which extends along the main axis X50 and along the deployment axis X1, in the deployment direction, from the inner portion 52 and opposite the activation system 30. The free end 54 of the protective element 50 thus extends out of the housing 14, so as to be grasped by a user of the medical device 10. The free end 54 of the protective element 50 preferably has a shape facilitating grasping by a user.

[0077] When the injection element 22 is in the retracted position and the protective element 50 is assembled on the injection system 20, the free end 54 of the protective element 50 allows the removal of the protective element 50. In other words, when a user grasps the free end 54 and pulls the protective element 50 in the deployment direction, the protective element 50 detaches from the injection system 20 and the inner portion 52 comes out of the housing 14 through the opening 18.

[0078] The clamping force of the retaining end 52A on the guide portion 34 is high enough to prevent accidental movement along the deployment axis X1 of the retaining end 52A relative to the guide portion 34, but low enough to allow easy removal of the protective element 50 when a user pulls on its free end 54 in the deployment direction.

[0079] In the embodiment shown in Figures 1 to 4, as seen in Figure 1, the free end 54 of the protective element 50 has a biconcave profile, more precisely a truncated cylinder shape formed by two surfaces, for example, two curved surfaces or two flat surfaces. Furthermore, preferably, the free end 54 has ribs 55 that facilitate a user's grip when pulling on the protective element 50 to remove it from the medical device 10.

[0080] An external main diameter D52 of the inner portion 52 of the protective element 50 is less than or equal to a diameter D18 of the opening 18, for example, to the largest diameter D18 of the opening 18, allowing the inner portion 52 to be removed from the internal compartment V14 of the housing 14 by moving the free end 54 along the deployment axis X1, in the deployment direction. The external main diameter D52 corresponds to the largest diameter of the inner portion 52 and, in this embodiment, is measured at the retention end 52A. The entire protective element 50 is able to pass through the opening 18. This is advantageous when the assembly comprising the injection system 20 and the protective element 50, previously mounted on the injection system 20, is mounted in the deployment direction within the housing 14, for example, in a half-shell of the housing including the wall 16.Furthermore, in this embodiment, the inner portion 52 of the protective element 50 is slightly conical, converging towards the opening 18.

[0081] The protective element 50 also stabilizes the injection system 20 by preventing the injection element 22 from moving along the deployment axis X1. In the embodiment shown in Figures 1 to 4, the protective element 50 specifically prevents the injection element 22 from moving in the deployment direction, thus avoiding an unexpected movement of the injection element 22 from its retracted position to its deployed position. Advantageously, the protective element 50 also prevents abnormal movement of the injection element 22 from its retracted position in the retraction direction, i.e., movement of the injection element 22 away from the opening 18 beyond its retracted position, such movement potentially causing a malfunction of the injection system 20.

[0082] For this purpose, the protective element 50 includes at least one retaining element 56. When the injection element 22 is in the retracted position and the protective element 50 is assembled on the injection system 20, the at least one retaining element 56 prevents the injection element 22 from moving along the deployment axis X1. In particular, the at least one retaining element 56 prevents the injection element 22 from moving along the deployment direction, from its retracted position to its deployed position.

[0083] Advantageously, at least one retaining element 56 is supported against the wall 16 of the housing 14 when the injection element 22 is in the retracted position and the protective element 50 is assembled on the injection system 20, so that at least one retaining element 56 cooperates with the wall 16 of the housing 14 to oppose the movement of the injection element 22 along the deployment axis X1, in association with the assembly of the protective element 50 on the support 32.

[0084] Furthermore, in this first embodiment, at least one retaining element 56 is disposed between the inner portion 52 and the free end 54 of the protective element 50, along the deployment axis X1, so as to be disposed at the level of the opening 18, along the deployment axis, on the side of the internal compartment V14.

[0085] At least one retaining element 56 includes an internal support element 56A, bearing against an internal surface 16A of the wall 16 of the housing 14, around the opening 18, when the injection element 22 is in the retracted position and the protective element 50 is assembled on the injection system 20, so that the internal support element 56A cooperates with the internal surface 16A of the housing wall to oppose the movement of the injection element in the deployment direction.

[0086] In the embodiment shown in Figures 1 to 4, the internal support element 56A comprises several protrusions, advantageously four protrusions, distinct from one another and distributed around the periphery of the inner portion 52 of the protective element 50. These protrusions are identical to those visible in Figure 6, corresponding to another embodiment of the invention, described below. In a variant of the invention not shown, the internal support element 56A comprises a single collar-shaped protrusion that extends continuously around the inner portion 52.

[0087] Advantageously, the internal support element 56A of at least one retaining element 56 of the protective element 50 extends outward from the rest of the protective element 50, preferably radially with respect to the main axis X50 and the deployment axis X1, so that a diameter D56 of the protective element 50, for example the largest diameter D56, at the level of the internal support element 56A is greater than the diameter D18 of the opening 18, for example the largest diameter D18.

[0088] Thus, since the protective element 50 is fixed on the injection system 20, in particular by fitting onto the guide portion 34, an accidental displacement of the injection element 22 in the deployment direction is prevented by the support of at least one retaining element 56, more precisely of the internal support element 56A, against the internal surface 16A of the wall 16 of the housing 14. In particular, the internal support element 56A makes it possible to oppose an accidental displacement of the injection element 22 in the deployment direction from its retracted position to its deployed position.Indeed, the internal support element 56A is arranged so that its contact with the internal surface 16A creates sufficient resistance to prevent accidental displacement of the injection element 22 in the deployment direction, while remaining weak enough to allow the protective element 50 to be removed by a user manipulating its free end 54. In practice, when the protective element 50 is removed, the force exerted by a user on the free end 54 is sufficient to deform, preferably elastically, the internal support element 56A and allow it to slide against the internal surface 16A and then pass through the opening 18.

[0089] Thus, the protective element 50, in addition to ensuring the protection, for example sterility, of the free end 24 of the injection element 22, makes it possible to avoid accidental movement of the injection element 22 from its retracted position to its deployed position while being easily detachable from the medical device 10 before its use.

[0090] Advantageously, the retaining end 52A of the inner portion 52 abuts against the injection system 20, and more particularly against the support 32 of the activation system 30, specifically against the first drive element 36, along the deployment axis X1, in the direction opposite to the deployment direction. Thus, the protective element 50 bears, in the deployment direction, against the housing 14 by its internal support element 56A, and bears, in the direction opposite to the deployment direction, against the injection system 20 by its retaining end 52A, ensuring good stabilization of the position of the support 32 along the deployment axis X1 and further reducing the risk of accidental displacement of the injection element 22 from its retracted to its deployed position.

[0091] The retaining end 52A of the inner portion 52 of the protective element 50 continuously surrounds the injection element 22, in a circumferential direction to the deployment axis X1, and at least 50% of the continuous surface, i.e. at least 50% of the retaining end 52A, preferably at least 80%, is in contact with the injection system 20, more precisely with the first drive element 36. Thus, the protective element 50 effectively stabilizes the injection system 20, in particular the support 32 and the first drive element 36, and therefore stabilizes the injection element 22.

[0092] The retaining end 52A may have a flared shape, wider than the rest of the inner portion 52, to allow better support against the injection system 20.

[0093] Advantageously, at least one retaining element 56 of the protective element 50 also includes a holding surface 56B, bearing against the wall 16 of the housing 14, more precisely against an edge 18A of the opening 18, when the injection element 22 is in the retracted position and the protective element 50 is assembled on the injection system 20, so that the holding surface 56B cooperates with the wall 16, more precisely with the edge 18A of the opening 18, to oppose by friction a displacement of the injection element 22 along the deployment axis X1. In other words, the support of the retaining surface 56B against the edge 18A improves the stability of the injection system 20 and further reduces the risks of accidental displacement of the injection element along the deployment axis X1, in the direction of deployment from its retracted position to its deployed position, and also in the direction of retraction, beyond its retracted position.In practice, the support surface 56B can be continuous, or discontinuous, in a circumferential direction to the deployment axis X1.

[0094] Preferably, the retaining surface 56B also opposes a displacement of the injection element 22 in a direction perpendicular to the deployment axis X1. Thus, the stability of the injection system 20 is further improved.

[0095] Advantageously, the protective element 50 is a single piece. "Single piece" means that it is not a reversible assembly of several separate parts. A single piece is, for example, a part made of several elements or materials that cannot be disassembled, for example, formed by overmolding, or a part made of a single piece of material.

[0096] Protective element 50 is, for example, formed by injection molding.

[0097] Advantageously, at least one retaining element 56, here the internal support element 56A and the retaining surface 56B, is made of a material elastically deformable under the normal temperature conditions of use of the medical device 10. For example, the material of at least one retaining element 56 can be chosen from elastomers, in particular thermoplastic elastomers (TPE), various rubbers, natural or synthetic, thermoplastics, in particular polyolefins, or mixtures thereof.

[0098] Advantageously, the entire protective element 50 is made of elastically deformable material under normal temperature conditions of use of the medical device 10, preferably in the same material as at least one retaining element 56, for example in thermoplastic elastomer (TPE).

[0099] A second and a third embodiment of the medical device 10 are now described, with reference to Figures 5 and 6 and Figures 7 and 8, respectively. In the second and third embodiments, the elements analogous to those of the first embodiment bear the same reference numerals and function in the same way. If a reference numeral is used in the description of the second and third embodiments but is not shown in the corresponding figures, it refers to the part or component bearing the same reference numeral in the first embodiment. The following primarily describes the differences between each embodiment and the preceding one(s). The second embodiment differs from the first embodiment in that the protective element 50 of the medical device 10 has a flexible connection 60 between the inner portion 52 and the free end 54.The foldable link 60 allows the free end 54 to pivot relative to the inner portion 52, around an axis of rotation Y perpendicular to the main axis X50.

[0100] As can be seen from Figure 5, the foldable link 60 is particularly advantageous for improving the compactness of the medical device 10 along the deployment axis X1. Indeed, thanks to the foldable link 60, the free end 54 of the protective element 50 can be folded against the patch 12, particularly when transporting the medical device 10. Furthermore, the foldable link 60 allows a user of the medical device 10 to align the free end 54 with the main axis X50 and with the deployment axis X1 when the user wishes to remove the protective element 50 from the housing 14, for example, before using the medical device 10.

[0101] The 60 folding link is preferably a hinge, pivot or ball joint.

[0102] In the second embodiment, the foldable joint 60 is a hinge formed by a thinned portion of the protective element 50, i.e., by a portion thinner than any part of the free end 54 and any part of the inner portion 52, and which extends in a direction perpendicular to the axis of rotation Y and to the main axis X50. In other words, the protective element 50 is a single piece and the folding of the free end 54 relative to the inner portion 52 around the axis of rotation Y is made possible by the elastic deformation of the hinge 60, i.e., by folding.

[0103] The third embodiment differs from the first embodiment in that at least one retaining element 56 of the medical device 10 comprises, in addition to the internal support element 56A and the holding surface 56B, an external support element 56C.

[0104] The internal support element 56A of the third embodiment functions like that of the first embodiment, that is to say it is supported against the internal surface 16A of the wall 16 of the housing 14, around the opening 18, when the injection element 22 is in the retracted position and the protection element 50 is assembled on the injection system 20, so that the internal support element 56A cooperates with the internal surface 16A of the housing wall to oppose the movement of the injection element 22 in the deployment direction. In addition, the internal support element 56A comprises several protrusions, advantageously four protrusions, distinct from one another and distributed around the perimeter of the inner portion 52 of the protective element 50. In a non-shown variant of the invention, the internal support element 56A comprises a protrusion which extends continuously around the inner portion 52.The retaining surface 56B of the third embodiment functions like that of the first embodiment, that is to say it is in contact with the edge 18A of the opening 18 when the injection element 22 is in the retracted position and the protective element 50 is assembled on the injection system 20, so that the retaining surface 56B cooperates with the edge 18A of the opening 18 to oppose by friction a displacement of the injection element 22 along the deployment axis X1.

[0105] The external support element 56C bears against an external surface 16B of the wall 16 of the housing 14 when the injection element 22 is in the retracted position and the protective element 50 is assembled onto the injection system 20, such that the external support element 56C cooperates with the external surface 16B of the housing wall to resist displacement of the injection element 22 along the deployment axis X1 in the retraction direction, particularly beyond the retracted position of the injection element 22. In other words, the external support element 56C is arranged between the inner portion 52 and the free end 54 of the protective element 50, along the deployment axis X1, so as to be positioned at the opening 18, along the deployment axis X1, on the outside of the housing 14.

[0106] Advantageously, the internal support elements 56A and external support elements 56C of at least one retaining element 56 of the protective element 50 of the third embodiment extend in projection from the rest of the protective element 50, preferably radially with respect to the deployment axis X1, so that a diameter D56, for example the largest diameter D56, of the protective element 50 at the level of the internal support element 56A and the external support element 56C is greater than the diameter D18 of the opening 18, for example the largest diameter D18.

[0107] Since the protective element 50 is fixed to the injection system 20, in particular by fitting onto the guide portion 34, accidental displacement of the injection element in the deployment direction, but also in the opposite direction, is prevented by the support of the internal support elements 56A and external support elements 56C, respectively against the internal surface 16A and external surface 16B of the wall 16 of the housing 14. In addition, the retaining surface 56B also helps to resist, by friction, any displacement of the injection element 22 along the deployment axis X1. Thus, in the third embodiment, the injection system 20 is better stabilized by the protective element 50, so that the risk of accidental displacement of the injection element 22 is further reduced.

[0108] According to a fourth embodiment not shown, at least one retaining element 56 does not include the holding surface 56B. For example, the largest diameter of the protective element 50 measured at the opening 18, along the deployment axis X1, is less than the diameter D18 of the opening 18, for example, the largest diameter D18, so that the protective element 50 is not in contact with the edge 18A of the opening 18. In this embodiment, only the internal support element 56A and / or the external support element 56C oppose(s) the movement of the injection element 22 along the deployment axis X1.

[0109] According to a fifth embodiment not shown, the at least one retaining element 56 comprises only the retaining surface 56B, i.e., it does not include the internal support element 56A or the external support element 56C. In this embodiment, only the friction between the retaining surface 56B and the edge 18A of the opening 18 opposes the movement of the injection element 22 along the deployment axis X1.

[0110] According to a sixth embodiment not shown, at least one retaining element 56 comprises the external support element 56C and optionally the retaining surface 56B, but does not comprise the internal support element 56A. In this embodiment, the external support element 56C opposes a displacement of the injection element 22 along the deployment axis X1 in the retraction direction, in particular beyond the retracted position of the injection element 22 and, preferably, the retaining surface 56B opposes a displacement of the injection element 22 along the deployment axis X1 in the retraction direction and in the deployment direction.

[0111] According to a seventh embodiment (not shown), the injection element 22 is a rigid needle, so the insertion element 43 is not needed to assist the insertion of the injection element 22 into the target layer and is therefore omitted. In such a variant, the design of the support 32 is preferably simplified, for example, by not providing a second drive element 38 or a spring 39. According to this embodiment, the support 32 comprises, for example, the guide portion 34 and the first drive element 36. Activation of the control element causes the support 32 to translate along the deployment axis X1, in the deployment direction, moving the injection element 22 from its retracted position to its deployed position.The translation of the support 32 is, for example, driven, identically to the first embodiment, by the spring 41 following the rotation of the actuating arm 40 in a first direction around the actuating axis X2, which is itself driven by the motor. Alternatively, the translation of the support 32 is driven by another means. According to this seventh embodiment, the injection of medicinal fluid is then possible as soon as the injection element is in its deployed position. Indeed, since the insertion element 43 is absent, there is no step of removing the insertion element 43 from inside the injection element 22. The flow of medicinal fluid from the reservoir to the injection element 22 is, for example, carried out identically to the embodiments described previously.

[0112] This seventh embodiment is particularly advantageous in the case of a non-portable medical device. Any feature described for an embodiment or variant in the foregoing may be implemented for the other embodiments and variants described above, provided it is technically feasible.

Claims

1. DEMANDS 1. Medical device (10), comprising: a housing (14), having a wall (16) through which an opening (18) passes, an injection system (20), comprising: o an injection element (22), having a free end (24), and o an activation system (30), disposed in the housing (14), coupled to the injection element (22) and configured to move the injection element along a deployment axis (X1) so as to drive the injection element between at least: ■ a retracted position, and ■ a deployed position in which the injection element (22) extends through the opening (18) such that the free end (24) of the injection element (22) extends outside the housing (14), a protective element (50), comprising at least one retaining element (56), the protective element (50) being capable of being removably assembled onto the injection system (20) at least when the injection element (22) is in its retracted position, a medical device (10) in which, when the injection element (22) is in the retracted position and the protective element (50) is assembled onto the injection system (20): the protective element (50) and the activation system (30) form between them a closed internal volume (V50), in which the free end (24) of the injection element (22) is disposed, a free end (54) of the protective element (50) extends outside the housing (14),and at least one retaining element (56) of the protective element (50) prevents displacement of the injection element (22) along the deployment axis (X1).

2. Device (10) according to claim 1, wherein at least one retaining element (56) of the protective element (50) is in contact with the wall (16) of the housing (14) when the injection element (22) is in the retracted position and the protective element (50) is assembled on the injection system (20), so that at least one retaining element (56) cooperates with the wall (16) of the housing (14) to oppose the movement of the injection element (22) along the deployment axis (X1).

3. Device (10) according to claim 2, wherein at least one retaining element (56) comprises a retaining surface (56B) bearing against an edge (18A) of the opening (18) when the injection element (22) is in the retracted position and the protective element (50) is assembled on the injection system (20), such that the retaining surface (56B) cooperates with the edge (18A) of the opening (18) to oppose a displacement of the injection element (22) along the deployment axis (X1) as well as, preferably, in a direction perpendicular to the deployment axis (X1).

4. Device (10) according to any one of claims 2 to 3, wherein at least one retaining element (56) comprises an internal support element (56A), bearing against an internal surface (16A) of the wall (16) of the housing (14) when the injection element (22) is in the retracted position and the protective element (50) is assembled on the injection system (20), such that the internal support element (56A) cooperates with the internal surface (16A) of the wall (16) of the housing (14) to oppose the movement of the injection element (22) along the deployment axis (X1) in a deployment direction of the injection element (22).

5. Device (10) according to any one of claims 2 to 4, wherein at least one retaining element (56) comprises an external support element (56C), bearing against an external surface (16B) of the wall (16) of the housing (14) when the injection element (22) is in the retracted position and the protective element (50) is assembled on the injection system (20), such that the external support element (56C) cooperates with the external surface (16B) of the wall (16) of the housing (14) to oppose a displacement of the injection element along the deployment axis (X1) in a retraction direction of the injection element (22).

6. Device (10) according to any one of claims 2 to 3, wherein at least one retaining element (56) of the protective element (50) comprises at least one support element (56A, 56C) extending in projection from the rest of the protective element (50).

7. Device (10) according to any one of the preceding claims, wherein the protective element (50) is able to be removably assembled onto the activation system (30), in particular by fitting or clipping.

8. Device (10) according to claim 7, wherein the activation system (30) comprises a support (32) extending along the deployment axis (X1) and surrounding a portion of the injection element (22), wherein the injection element (22) is coupled to the support (32) and in which, when the injection element (22) is in the retracted position and the protective element (50) is assembled on the injection system (20), the protective element (50) is fitted onto the support (32).

9. Device (10) according to any one of the preceding claims, wherein, when the injection element (22) is in the retracted position and the protective element (50) is assembled on the injection system (20), a retaining end (52A) of the protective element (50) is abutted against the injection system (20) along the deployment axis (X1).

10. Device (10) according to claim 9, wherein, when the injection element (22) is in the retracted position and the protection element (50) is assembled on the injection system (20), the retaining end (52A) of the protection element (50) is abutted against the activation system (30) along the deployment axis (X1).

11. Device (10) according to any one of claims 9 and 10, wherein the retaining end (52A) of the protective element (50) forms a continuous surface around the injection element (22), in a circumferential direction to the deployment axis (X1), and wherein at least 50% of the continuous surface is abutting the injection system (20).

12. Device (10) according to any one of the preceding claims, wherein the entire protective element (50) is capable of passing through the opening (18).

13. Device (10) according to any one of the preceding claims, wherein the protective element (50) is monobloc.

14. Device (10) according to any one of the preceding claims, wherein the protective element (50) comprises an inner portion (52), disposed inside the housing (14) and forming, with the activation system (30), the closed inner volume (V50) when the injection element (22) is in the retracted position and the protective element (50) is assembled on the injection system (20), wherein the free end (54) of the protective element is connected to the inner portion (52) of the protective element by a foldable linkage (60) and wherein the foldable linkage is, preferably, a hinge, a pivot or a ball joint.

15. Device (10) according to any one of the preceding claims, wherein, when the injection element (22) is in the retracted position and the protective element (50) is assembled on the injection system (20), the free end (54) of the protective element (50) allows the protective element (50) to be withdrawn from the housing (14).

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