Device for fluidly connecting a medical container to a connector and method of making the same

Abstract

The device (1) comprises: a housing (2) defining an internal conduit (20) for circulating a medical fluid from a fluid inlet (22) to a fluid outlet (24); a slide (5) arranged inside the internal conduit (20) so that the slide (5) can move along a central longitudinal axis between an open position and a closed position, wherein the open position allows the medical fluid to flow through the fluid outlet (24) and the closed position prevents the medical fluid from flowing through the fluid outlet (24); a plug (4) connected to the slide (5), the plug (4) being configured to close the fluid outlet (24) when the slide (5) is in the closed position; an elastic member (7) disposed proximally of the plug and configured to exert a proximal force on the slide (5) so that the elastic member (7) holds the slide (5) in the open position; and a proximally directed pressure region (50) disposed on an actuating member (52) of the slide (5).

Description

Technical Field

[0001] The present invention relates to a device configured to be plugged into a medical container, such as a syringe, and a connector, such as a vascular access device, a catheter, or a needle hub, for infusing or injecting a medical fluid into a patient. The present invention also relates to a medical container and a connector comprising the device, and to a method for manufacturing the device. Background Art

[0002] In the present application, the distal end of a component or device should be understood to mean the end closest to the patient, and the proximal end should be understood to mean the end farthest from the patient. Similarly, in the present application, the "distal direction" should be understood to mean the direction of infusion or injection, and the "proximal direction" should be understood to mean the direction opposite to the direction of infusion or injection, i.e., the direction away from the patient.

[0003] Typically, medical injection devices are used to inject a limited amount of a pharmaceutical composition into the body. When a larger amount or volume of a pharmaceutical composition is to be infused into the body, a vascular access device can be used. Such a device is inserted into a vein via a peripheral or central blood vessel. A vascular access device can be used to infuse fluids (e.g., saline solution, blood, medicaments, and / or total parenteral nutrition) into a patient, to withdraw fluids (e.g., blood) from a patient, and / or to monitor various parameters of a patient's vascular system.

[0004] However, vascular access devices can become blocked. To ensure that vascular access devices are used appropriately and do not become blocked, standards of practice have been developed. These standards include cleaning procedures, which are often referred to as flushing procedures. These flushing procedures maintain the patency of vascular access devices.

[0005] Flushing procedures can be enhanced by using syringes specifically designed to generate lower injection pressures (e.g., 10 mL-volume syringe barrels) or by using "push-pause" or pulsatile flushing techniques to remove debris or residue from the catheter that could cause blockage or other undesirable effects. However, these procedures are difficult and demanding for healthcare practitioners and may result in the pharmaceutical composition being injected into the patient's vein too quickly.

[0006] Rapid injection of the pharmaceutical composition into a peripheral intravenous line may result in a temporary increase in pressure within the catheter and the vein in which the catheter is located. This excessive pressure may cause venous damage, such as rupture or collapse. In addition, the infused medical composition may seep or leak outside the infusion device, causing clinical complications and the need to replace the infusion device (such as a peripheral intravenous catheter) and / or change the infusion site.

[0007] Therefore, there is a need for a drug delivery device that is able to ensure that the flush injection pressure remains below a predetermined threshold in order to avoid the above-mentioned disadvantages.

[0008] Document US2003078534 proposes minimizing the subjective pain response and any potential tissue damage to the patient caused by undue pressure generated during the administration of a drug via a hypodermic needle. However, the device in this document is power-driven and includes multiple components, such as a drive mechanism and sensors to determine the internal pressure generated during the injection process, resulting in more complex use, high costs, and a complicated device. Summary of the Invention

[0009] In this context, it is an object of the present invention to provide a device that alleviates the above-mentioned drawbacks by limiting the infusion pressure from the syringe to the vascular access device, thereby avoiding damage to the blood vessels, while being compact and easy to handle and manufacture.

[0010] A first aspect of the present invention is to provide an apparatus for fluidly connecting a medical container containing a medical fluid to a connector, such as a medical device, wherein the apparatus comprises:

[0011] a housing defining an internal conduit for circulating the medical fluid from a fluid inlet to a fluid outlet,

[0012] a slider disposed within the inner conduit such that the slider is movable along a central longitudinal axis A between an open position permitting the medical fluid to flow through the fluid outlet and a closed position preventing the medical fluid from flowing through the fluid outlet,

[0013] a plug connected to the slider, the plug being configured to close the fluid outlet when the slider is in the closed position,

[0014] a resilient member disposed proximally of the plug and configured to exert a proximal force on the slider such that the resilient member retains the slider in the open position, and

[0015] A proximally directed pressure area is provided on the actuating member of the slider, and the pressure area is configured to cause the slider to overcome the action of the elastic member and reach the closed position when the pressure of the medical fluid applied to the pressure area is equal to or higher than a predetermined threshold, thereby causing the plug to close the fluid outlet.

[0016] The medical device of the present invention thus allows limiting the infusion pressure in the vascular access device. This prevents damage to the blood vessels. The pressure limiting mechanism of the device is not motor-driven and requires a limited number of components, thereby improving compactness and limiting costs.

[0017] In one embodiment, the actuation member comprises a peripheral edge configured to guide sliding movement of the slide between the open position and the closed position.

[0018] In one embodiment, the pressure region defines at least two through-holes allowing the medical fluid to pass through the actuation member.

[0019] Preferably, the at least two through holes are symmetrical with respect to a longitudinal plane containing the central longitudinal axis A.

[0020] This provides a symmetrical flow path through the pressure region and thus provides a uniform pressure onto said pressure region, so as to avoid any tilting movement of the slide or any clogging, thereby increasing the reliability of the device.

[0021] Preferably, the actuating member is disc-shaped.

[0022] Preferably, the pressure zone is orthogonal to the central longitudinal axis A.

[0023] In one embodiment, the slider comprises a connecting rod extending along the central longitudinal axis A, the connecting rod connecting the actuating member to the plug.

[0024] Preferably, the actuating member is integral with the connecting rod, such that the actuating member and the connecting rod form a single component.

[0025] Preferably, the elastic member is a bellows extending around the connecting rod.

[0026] Preferably, the device comprises a retaining member comprising a guide element for guiding the connecting rod along the central longitudinal axis A, an outer ring forming part of the housing, and a retaining element connecting the guide element to the outer ring such that the retaining element defines an opening for allowing the medical fluid to flow through the retaining member.

[0027] Preferably, the resilient member extends between the actuating member and a guide element of the holder.

[0028] Preferably, the housing comprises a top housing and a bottom housing, the outer ring of the retaining member forming an intermediate housing portion between the top housing and the bottom housing.

[0029] In one embodiment, the plug is made of a softer material than the slider.

[0030] Another aspect of the present invention is to provide a medical container comprising a reservoir for containing a medical fluid and the above-described device fluidly connected to the reservoir of the medical container.

[0031] Another aspect of the present invention is to provide a method for manufacturing the above-mentioned device, the method comprising the following steps:

[0032] - Assembling the retaining element, the sliding element, the elastic member and the plug;

[0033] - fixing the retaining element to the bottom shell, preferably by ultrasonic welding;

[0034] - The retaining element is preferably fixed to the top shell by ultrasonic welding. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The present invention and the advantages resulting therefrom will become apparent from the following detailed description given with reference to the accompanying drawings:

[0036] - Figure 1 is a perspective view of a device according to an embodiment of the present invention;

[0037] - Figure 2 is a cross-sectional view of a longitudinal plane of a device according to an embodiment of the present invention;

[0038] - Figure 3 is an exploded view of a device according to an embodiment of the present invention;

[0039] - Figure 4 A cross-sectional view in a longitudinal plane illustrating the operation of the apparatus according to an embodiment of the present invention;

[0040] - Figure 5 is a semi-transparent perspective view of a device according to an embodiment of the present invention;

[0041] - Figure 6 A cross-sectional view in a longitudinal plane illustrating the operation of the apparatus according to an embodiment of the present invention; and

[0042] - Figure 7 is a perspective view of a portion of a medical container and a vascular access device according to an embodiment of the present invention. DETAILED DESCRIPTION

[0043] refer to Figure 1 , shows a device 1 according to an embodiment of the present invention. Figure 7As illustrated in FIG, the device 1 is configured to be connected to a medical container 100, such as a prefilled or prefillable syringe, and to a connector 200, such as a needle hub or a vascular access device, such as an IV (intravenous) catheter, so that the medical fluid contained in the medical container 100 passes through the device 1 before reaching the connector 200. The device 1 is intended to be an add-on device. Thus, the medical container 100 can be connected to the connector 200 without the device 1 of the present invention. The medical container 100 generally includes a barrel 108 defining a reservoir for containing a medical fluid and a distal end 102 defining a passageway in fluid communication with the reservoir. The medical container 100 may include a stopper 110 and a plunger rod 112 for expelling the medical product through the distal end 102.

[0044] refer to Figure 1 and 2 , an additional device 1 may include a housing 2 defining an internal conduit 20 for circulating a medical product through the device 1 from a fluid inlet 22 to a fluid outlet 24. The housing 2 has a proximal end 26 provided with proximal connection means, such as threads or wings 262, for connecting the device 1 to a medical container 100 so that a medical fluid contained in the medical container 100 flows from the medical container 100 to the device 1 via the fluid inlet 22, and a distal end 28 provided with distal connection means, such as threads 284, for connecting the device 1 to a connector 200 so that a medical fluid flows from the device 1 to the connector 200 via the fluid outlet 24.

[0045] The device 1 further comprises a plug 4 for closing the fluid outlet 24, a plug 4 which can be used together with the plug 4 in an open position ( Figure 2 ) and the closed position in which the plug 4 closes the fluid outlet 24 ( Figure 6 ), a sliding member 5 that moves between the open position and the closed position, an elastic member 7 that pushes the sliding member 5 and the plug 4 toward the open position, and a retaining member 8 for guiding the sliding movement of the sliding member 5 along the central longitudinal axis A of the device 1 between the open position and the closed position.

[0046] refer to Figures 4 to 6 The slider 5 includes a pressure region 50 arranged in the proximal portion of the flow path of the medical fluid, so that the medical fluid circulating inside the inner tubing 20 exerts a distal pressure on the pressure region 50. The pressure region 50 is configured such that the medical fluid pressure exerted thereon causes the slider 5 and the plug 4 to move distally toward the closed position, overcoming the action of the elastic member 7.

[0047] As long as the pressure remains below a predetermined threshold, the elastic member 7 holds the plug 4 away from the fluid outlet 24 and the slider 5 remains in the intermediate position ( Figure 4) and does not reach the closed position. Therefore, the medical fluid can flow downstream through the connector 200.

[0048] When the pressure becomes equal to the predetermined threshold, the distal force applied to the pressure region 50 overcomes the proximal force of the elastic member 7, thereby causing the slider 5 to reach the closed position and causing the plug 4 to close the fluid outlet 24. The medical fluid is thereby prevented from flowing through the connector 200. When the pressure of the medical fluid applied to the pressure region 50 is equal to or higher than the predetermined threshold, the medical fluid is prevented from flowing through the connector 200.

[0049] The pressure region 50, the predetermined pressure threshold and the slider 5 are Figure 2 The open position shown in Figure 6 The travel distance between the closed positions shown in FIG can be determined based on the volume of medical fluid to be infused and / or the size of the medical container 100 (e.g., the inner diameter of the container). For example, the area of ​​the pressure region 50 can be comprised within 30 mm. 2 With 35mm 2 between, preferably about 33 mm 2 The predetermined threshold value may be approximately or equal to 25 psi, that is, at 1.7×10 5 Pa and 1.8×10 5 Pa. Slider 5 is between Figure 2 The open position shown in Figure 6 The travel distance between the closed positions shown in may be, for example, approximately 2 mm.

[0050] The pressure region 50 may be defined by the proximal surface of the disc-shaped actuating member 52 of the slider 5. The pressure region 50 is preferably orthogonal to the longitudinal axis A. Figure 4 As shown in FIG. 6 , the slider 5 , and more specifically the actuation member 52 , is configured to allow the medical fluid to flow inside the inner conduit 20 without blocking the medical fluid, regardless of the position of the slider 5 .

[0051] Thus, the actuation member 52 may include at least one, preferably two, through-holes 54 that allow the medical fluid to pass through the pressure zone 50. The through-holes 54 are preferably symmetrical about a longitudinal plane containing the central longitudinal axis A, so that the flow of the medical fluid remains symmetrical. In an alternative embodiment that is not shown, the peripheral edge 56 of the actuation member 52 may include a notch that allows the medical fluid to pass through the slider 5, more precisely between the slider 5 and the inner surface of the internal tubing 20.

[0052] The elastic member 7 may be in the form of a bellows. In the absence of medical fluid circulating inside the device 1, the elastic member 7 holds the slider 5 and the plug 4 in the position shown in FIG. Figure 2, which is the most proximal position of the slider 5. However, the resilient member 7 is designed to allow the slider 5 and the plug 4 to reach the closed position when the medical fluid pressure reaches or exceeds a predetermined threshold.

[0053] The slider 5 comprises a connecting member, such as an axially extending connecting rod 58, in order to connect the pressure zone 50 to the plug 4. The actuating member 52 may be integral with the connecting rod 58, such that the actuating member 52 and the connecting rod 58 form a single component.

[0054] However, reference Figure 3 , the plug 4 can be a separate component that is fixed to the connecting member, for example, by friction or via glue material. The plug 4 can include a hole 40 for receiving the connecting rod 58 and, if necessary, for receiving the glue material.

[0055] In the illustrated embodiment, the actuation member 52 is provided at the proximal end of the slider 5, more specifically at the proximal end of the connecting rod 58. The plug 4 is fixed to the distal end of the slider 5, more specifically to the distal end of the connecting rod 58. The elastic member 7 can be arranged around the connecting rod 58. The connecting rod 58 thus extends through the elastic member 7.

[0056] refer to Figure 2 and 3 , the holder 8 comprises a guide element configured to guide the translational movement of the slider 5 along the longitudinal axis A. The guide element may be in the form of an inner tubular ring 80 shaped to receive the connecting rod 58 of the slider 5 so that the connecting rod 58 slides into the inner tubular ring 80 .

[0057] It should be noted that the peripheral edge 56 of the slider 5, more specifically the peripheral edge 56 of the actuating member 52, can be configured to contact the inner wall of the inner pipe 20 when the slider 5 moves inside the inner pipe 20, so that the peripheral edge 56 helps guide the slider 5 along the longitudinal axis A.

[0058] The elastic member 7 has one end supported by the inner tubular ring 80 of the retainer 8 and an opposite end bearing against the distal face of the actuating member 52 .

[0059] The retaining member 8 may include retaining elements, such as radial spokes 82, for connecting the inner tubular ring 80 to the housing 2 without hindering the flow of the medical fluid inside the inner conduit 20. The radial spokes 82 thus define through-openings 86 for circulating the fluid through the retaining member 8. The spokes 82 may be regularly distributed in the circumferential direction.

[0060] refer to Figure 3, the housing 2 may include a top housing 30 and a bottom housing 32, and the holder 8 may include an outer ring 84 that may form a part of the housing 2. The top housing 30 may be fixed to the proximal side of the outer ring 84, and the bottom housing 32 may be fixed to the distal side of the outer ring 84.

[0061] refer to Figure 7 The proximal and distal connecting means are configured to allow for releasable connections between the device 1 and the medical container 100, and between the device 1 and the connector 200. Therefore, the device 1 is a separate component that is not integral with the medical container 100 or the connector 200. Therefore, healthcare practitioners can freely decide whether to remove the device 1 as needed.

[0062] The proximal connection device may include a female fitting 260, which may be in the form of a tubular portion, configured to tightly receive a male fitting corresponding to the cylindrical or conical distal end 102 of the medical container 100. In addition, the proximal connection device may include connection features, such as two diametrically opposed external wings 262, which are designed to engage the internal threads 104 of the adapter 106 mounted on the distal end 102 of the medical container 100. Thus, the proximal connection device can also be mated with any standard syringe (such as a 3 mL, 5 mL, or 10 mL syringe), and in particular can establish a Luer slip connection or a Luer lock connection with the medical container 100.

[0063] like Figure 1 、 Figure 2 and Figure 7 As can be seen in FIG, the distal connection device may include a male fitting 280, which may be in the form of a cylindrical or conical tubular end, configured to tightly engage the female fitting 202 of the connector 200. The distal connection device may also include a collar 282 provided with internal threads 284 for engaging corresponding external threads 204 arranged on the female fitting 202 of the connector 200. Therefore, the distal connection device is also preferably designed to mate with any standard fitting of the connector 200.

[0064] For example, reference Figure 4 , the inner tube 20 may include a first section 20a having a first diameter, a second section 20b located distal to the first section 20a and having a second diameter, and a third section 20c located distal to the second section 20b and having a third diameter. The second diameter may be larger than the first diameter. The third diameter may be smaller than the second diameter and may be smaller than the first diameter. The first section 20a and the second section 20b may be separated by a proximal tapered section 20d. In the same manner, the second section 20b and the third section 20c may be separated by a distal tapered section 20e. Figure 2In the open position, the actuating member 52 can abut the proximal tapered section 20d. In the closed position, the plug 4 can abut the distal tapered section 20e. In the intermediate position ( Figure 4 ), the pressure region 50 and the plug 4 may be away from the proximal tapered section 20d and the distal tapered section 20e.

[0065] In one embodiment, the plug 4 and the elastic member 7 are made of a softer material than the housing 2, the slider 5, and the retaining member 8. For example, the plug 4 and / or the elastic member 7 can be made of rubber or silicone. The housing 2, the slider 5, and / or the retaining member 8 can be made of polypropylene or polycarbonate. In one embodiment, the plug 4, the elastic member 7, the slider 5, the retaining member 8, and the housings 2 and 28 can be manufactured by injection molding.

[0066] refer to Figure 2 , the plug 4 may include a distal tapered portion 42 to seal the fluid outlet 24 .

[0067] Reference below Figure 2 、 4 , 5 and 6 describe the operation of the device 1. In the case where no medical fluid is circulated inside the device 1 ( Figure 2 ), the elastic member 7 holds the slider 5 in a position corresponding to the most proximal position of the slider 5. The plug 4 is away from the fluid outlet 24.

[0068] When the user pushes the plunger rod 112 of the medical container 100 for infusing the medical fluid, a distal pressure ( Figure 5 The distal pressure pushes the slider 5 in the distal direction, thereby compressing the elastic member 7. As long as the fluid pressure applied to the pressure area 50 is below a predetermined threshold, the slider 5 is held in the open position ( Figure 4 ), the open position is Figure 2 The open position shown is the same as Figure 6 The plug 4 is kept away from the fluid outlet 24 so as to allow the medical fluid to flow through the fluid outlet 24 toward the connector 200 (see arrow 240).

[0069] When the fluid pressure applied to the pressure region 50 reaches or exceeds a predetermined threshold, the distal force applied to the actuating member 52 overcomes the proximal force of the elastic member 7, thereby causing the slider 5 to move further in the distal direction until it reaches the closed position, in which the plug 4 closes the fluid outlet 24 ( Figure 6 ). As a result, the medical fluid is blocked inside the device 1 and cannot flow into the connector 200. Therefore, the healthcare practitioner who infuses the medical product must reduce the pressure applied by his fingers on the plunger rod 112 in order to perform the infusion.

[0070] When the fluid pressure applied to the pressure area 50 decreases and becomes below the predetermined threshold again, the elastic member 7 pulls the slide 5 towards the open position ( Figure 2 or 4) push back. The plug 4 moves proximally away from the fluid outlet 24 and again allows the medical fluid to exit the device 1 and flow in the connector 200.

[0071] refer to Figure 7 The present invention further relates to a medical container 100, such as a prefilled or prefillable syringe, comprising a barrel 108 defining a reservoir for containing a medical product, a distal tip 102 defining a passage in fluid communication with the reservoir, and the aforementioned device 1 connected to the distal tip 102. The medical container 100 may include a plunger 110 and a plunger rod 112 for expelling the medical product through the distal tip 102. The medical container 100 preferably comprises an adapter 106 mounted to the distal tip 102, the adapter 106 comprising connecting means, such as internal threads 104, which engage proximal connecting means provided at the proximal end of the device 1 for a secure connection.

[0072] The device of the present invention can also be connected to a connector 200, such as a needle hub or a vascular access device, such as an intravenous (IV) catheter or more specifically a peripheral intravenous (PIV) catheter. The device 1 is thus connected to the female fitting 202 of the connector 200. The female fitting 202 preferably has a connection means, such as an external thread 204, which engages the threaded collar 282 of the device 1 to secure the connection. The device 1 can further be connected to a medical container 100.

[0073] The present invention also relates to a method for manufacturing the above-mentioned device 1, comprising the following steps:

[0074] (i) Assembling the retainer 8, the slider 5, the elastic member 7 and the plug 4;

[0075] (ii) securing the retaining member 8 to the bottom housing 32, preferably by ultrasonic welding;

[0076] (iii) The holder 8 is fixed to the top case 30, preferably by ultrasonic welding.

[0077] In step (i), the elastic member 7 may first be positioned around the rod 58 of the slider 5. The rod 58 may then be inserted inside the inner tubular ring 80 of the retainer 8. The plug 4 may then be fixed to the slider 5, for example by gluing.

[0078] Thus, the device 1 of the present invention provides an easily installed additional component that allows for control of infusion and / or injection pressure. The device 1 prevents catheter blockage and blood vessel damage. The device 1 works with any syringe, catheter, needle, or NFC (needle-free connection) device, making it universal. Furthermore, a healthcare practitioner can remove the pressure control function by simply disconnecting the device 1.

Claims

1. A device (1) for fluidically connecting a medical container (100) containing a medical fluid to a connector (200), wherein the device (1) comprises: a housing (2) defining an internal conduit (20) for circulating the medical fluid from a fluid inlet (22) to a fluid outlet (24), a slider (5) arranged inside the inner conduit (20) so that the slider (5) can move along a central longitudinal axis A between an open position in which the medical fluid is allowed to flow through the fluid outlet (24) and a closed position in which the medical fluid is prevented from flowing through the fluid outlet (24), the slider (5) comprising a connecting rod (58) extending along the central longitudinal axis A, the connecting rod (58) connecting the actuating member (52) to a plug (4), the plug (4) connected to the slider (5), the plug (4) being configured to close the fluid outlet (24) when the slider (5) is in the closed position, a resilient member (7) disposed proximally of the plug (4) and configured to exert a proximal force on the slider (5) such that the resilient member (7) holds the slider (5) in the open position, and a proximally directed pressure region (50) provided on the actuating member (52) of the slider (5), the pressure region (50) being configured to cause the slider (5) to overcome the action of the elastic member (7) to reach the closed position when the pressure of the medical fluid applied to the pressure region (50) is equal to or higher than a predetermined threshold, thereby causing the plug (4) to close the fluid outlet (24); and A retainer (8), the retainer (8) comprising a guide element (80) for guiding the connecting rod (58) along the central longitudinal axis A, an outer ring (84) forming part of the housing (2), and a retaining element (82), the retaining element connecting the guide element (80) to the outer ring (84) so ​​that the retaining element (82) defines an opening (86) for allowing the medical fluid to flow through the retainer (8), one end of the elastic member (7) being supported by the guide element (80) of the retainer (8).

2. The device according to claim 1, characterized in that The actuating member (52) includes a peripheral edge (56) configured to guide the sliding movement of the slider (5) between the open position and the closed position, and the pressure region (50) defines at least two through-holes (54) that allow the medical fluid to pass through the actuating member (52).

3. The device according to claim 2, characterized in that The at least two through holes (54) are symmetrical with respect to a longitudinal plane containing the central longitudinal axis A.

4. The device according to claim 1, characterized in that The actuating member (52) is disc-shaped.

5. The device according to claim 1, characterized in that The pressure region (50) is orthogonal to the central longitudinal axis A.

6. The device according to claim 1, characterized in that The actuating member (52) is integral with the connecting rod (58) such that the actuating member (52) and the connecting rod (58) form a single component.

7. The device according to claim 1, characterized in that The elastic member (7) is a bellows extending around the connecting rod (58).

8. The device according to claim 1, characterized in that The elastic member (7) extends between the actuating member (52) and the guide element (80) of the retainer (8).

9. The device according to claim 1, characterized in that The housing (2) comprises a top housing (30) and a bottom housing (32), and the outer ring (84) of the retaining member (8) forms an intermediate housing (2) portion between the top housing (30) and the bottom housing (32).

10. The device according to any one of claims 1 to 9, characterized in that The plug (4) is made of a softer material than the slider (5).

11. A medical container (100) comprising a reservoir for containing a medical fluid and a device (1) according to any one of the preceding claims 1-10, the device (1) being fluidically connected to the reservoir of the medical container (100).

12. A method for manufacturing a device (1) according to any one of claims 1 to 10, comprising the steps of: Assembling the retaining member (8), the sliding member (5), the elastic member (7) and the plug (4); fixing the retaining member (8) to the bottom housing (32); The retainer (8) is secured to the top housing (30).

13. The method of manufacturing the device (1) according to claim 12, wherein: The step of fixing the retaining member (8) to the bottom shell (32) is performed by ultrasonic welding.

14. The method of manufacturing the device (1) according to claim 12, wherein: The step of fixing the retainer (8) to the top shell (30) is performed by ultrasonic welding.

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