Apparatus for fluidly connecting a medical container to a connector and method for manufacturing the apparatus

Abstract

The medical device includes a housing (2) defining an internal conduit (20) for circulating a medical fluid from a fluid inlet (22) to a fluid outlet (24), a slider (5) disposed within the internal conduit (20) and movable along a central longitudinal axis (A) between an open position and a closed position that permits and prevents the flow of the medical fluid to the fluid outlet (24), and a plug (4) connected to the slider (5) that closes the fluid outlet (24) when the slider (5) is in the closed position. a resilient member (7) disposed proximal to the plug and exerting a proximal force on the slider (5) to maintain the slider (5) in an open position; and a pressure region (50) provided on the actuating member (52) of the slider (5) and oriented proximally, which causes the slider (5) to reach a closed position against the action of the resilient member (7) when the medical fluid pressure is equal to or greater than a predetermined threshold, thereby causing the plug (4) to close the fluid outlet (24).

Description

[Technical Field]

[0001] The present invention relates to a device configured to plug into a medical container, such as a syringe, and a connector, such as a vascular access device, catheter, or needle hub, for the infusion or injection of a medical fluid into a patient. The present invention also relates to the medical container and connector that make up the device, as well as a method of manufacturing the device. [Background technology]

[0002] As used herein, the distal end of a component or device is understood to mean the end closest to the patient, and the proximal end is understood to mean the end furthest from the patient. Similarly, as used herein, a "distal direction" is understood to mean the direction of infusion or injection, and a "proximal direction" is understood to mean the direction opposite to the direction of infusion or injection, i.e., away from the patient.

[0003] Medical syringes are commonly used to inject limited amounts of pharmaceutical compositions into the body. To inject larger amounts of pharmaceutical compositions into the body, vascular access devices may be used. Such devices are inserted into veins via peripheral or central blood vessels. Vascular access devices can be used to inject fluids (e.g., saline, blood, medications, and / or total parenteral nutrition) into a patient's body, withdraw fluids (e.g., blood) from a patient, and / or monitor various parameters of a patient's vascular system.

[0004] However, vascular access devices can become occluded. Standards of care are established to ensure that vascular access devices are used properly and do not become occluded. These standards include cleaning procedures, commonly referred to as flush procedures. These flush procedures maintain the patency of the vascular access device.

[0005] The flushing procedure can be enhanced by using a syringe specially designed to generate lower injection pressures, such as a 10 mL syringe barrel, or by using "push-pause" or pulsatile flushing techniques to remove debris or residue within the catheter that may cause blockage or other undesirable effects. However, these procedures can be difficult for the medical professional and may result in too rapid an injection rate of the pharmaceutical composition into the patient's vein.

[0006] High-speed infusion of a pharmaceutical composition into a peripheral intravenous line can temporarily exert pressure within the catheter and the vein into which the catheter is placed. This excessive pressure can lead to vein damage, such as rupture or collapse. Furthermore, the medical composition being injected may seep or leak outside the infusion device, causing clinical complications or necessitating replacement of the infusion device, such as a peripheral intravenous catheter, or a change in the infusion site.

[0007] Therefore, to avoid the above drawbacks, there is a need for a drug delivery device that makes it possible to ensure that the flush injection pressure remains below a certain threshold.

[0008] U.S. Patent Application Publication No. 2003 / 078534 proposes a device that minimizes subjective pain responses and potential tissue damage caused by inappropriate pressure when administering drugs via subcutaneous injection. However, this device is power-driven and includes multiple components, including a drive mechanism and a sensor that measures the internal pressure generated during injection, making the device complicated to use, expensive, and cumbersome. Summary of the Invention [Problem to be solved by the invention]

[0009] Therefore, an object of the present invention is to alleviate the above drawbacks by limiting the injection pressure from the syringe to the vascular access device, to avoid damage to the blood vessel, and to provide a device that is compact, easy to handle, and easy to manufacture. [Means for solving the problem]

[0010] a slider disposed within the internal conduit, the slider being movable along a central longitudinal axis A between an open position, in which the medical fluid is permitted to flow through the fluid outlet, and a closed position, in which the medical fluid is prevented from flowing through the fluid outlet; a plug connected to the slider, the plug configured to close the fluid outlet when the slider is in the closed position; a resilient member disposed proximal to the plug, the resilient member configured to exert a proximal force on the slider to maintain the slider in the open position; and a proximally oriented pressure region on an actuation member of the slider, the slider configured to reach the closed position against the action of the resilient member when medical fluid pressure on the pressure region is equal to or greater than a predetermined threshold, thereby causing the plug to close the fluid outlet.

[0011] Therefore, the medical device of the present invention can limit the injection pressure in the vascular access device, thereby preventing damage to the blood vessel. Because the pressure limiting mechanism is not motor-driven, the number of parts is reduced, allowing for miniaturization and cost reduction.

[0012] In one embodiment, the actuation member includes a peripheral edge configured to guide the sliding movement of the slider between the open and closed positions.

[0013] In one embodiment, the pressure region defines at least two through holes that allow medical fluid to pass through the actuation member.

[0014] Preferably, the at least two through holes are symmetrical about a longitudinal plane containing the central longitudinal axis A.

[0015] This results in a symmetrical flow path in the pressure region and uniform pressure in the pressure region, which prevents tilting of the slider and any blockages, improving the reliability of the device.

[0016] Preferably, the actuating member is disc-shaped.

[0017] Preferably, the pressure regions are perpendicular to the central longitudinal axis A.

[0018] In one embodiment, the slider includes a connecting rod extending along a central longitudinal axis A, the connecting rod connecting the actuation member to the plug.

[0019] Preferably, the actuating member is integral with the connecting rod so that the actuating member and the connecting rod form a single part.

[0020] Preferably, the resilient member is a bellows extending around the connecting rod.

[0021] Preferably, the device includes a holder including a guide element for guiding the connecting rod along a central longitudinal axis A, an outer ring forming part of the housing, and a retaining element connecting the guide element to the outer ring, the retaining element defining an opening for allowing medical fluid to flow through the holder.

[0022] Preferably, the resilient member extends between the actuating member and the guide element of the holder.

[0023] Preferably, the housing comprises an upper housing and a lower housing, and the outer ring of the holder forms an intermediate housing part interposed between the upper and lower housings.

[0024] In one embodiment, the plug is made of a softer material than the slider.

[0025] Another aspect of the present invention comprises a medical container having a reservoir for containing a medical fluid, and the aforementioned device fluidly connected to the reservoir of the medical container.

[0026] Another aspect of the present invention is a method for manufacturing the aforementioned device, comprising the steps of assembling a holder, a slider, an elastic member, and a plug; fixing the holder to a lower housing, preferably by ultrasonic welding; and fixing the holder to an upper housing, preferably by ultrasonic welding. [Brief explanation of the drawings]

[0027] The invention and the advantages arising therefrom will become more apparent from the detailed description set forth below, taken in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 is a perspective view of an apparatus according to one embodiment of the present invention. [Figure 2] FIG. 2 is a cross-section in a longitudinal plane of a device according to one embodiment of the present invention. [Figure 3] FIG. 3 is an exploded perspective view of an apparatus according to one embodiment of the present invention. [Figure 4] FIG. 4 is a cross-sectional view in a longitudinal plane illustrating the operation of a device according to one embodiment of the present invention. [Figure 5] FIG. 5 is a semi-transparent perspective view of an apparatus according to one embodiment of the present invention. [Figure 6] FIG. 6 is a cross-sectional view in a longitudinal plane illustrating the operation of a device according to one embodiment of the present invention. [Figure 7] FIG. 7 is a perspective view showing a portion of a medical container and a vascular access device according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0028] Referring to FIG. 1 , a device 1 according to one embodiment of the present invention is shown. As shown in FIG. 7 , the device 1 is configured to connect to a medical container 100, such as a pre-filled or pre-fillable syringe, and a connector 200, such as a needle hub or a vascular access device, e.g., an IV (intravenous) catheter, such that medical fluid contained in the medical container 100 passes through the device 1 before reaching the connector 200. It is contemplated that the device 1 is an add-on device. Thus, it is also possible to connect the medical container 100 to the connector 200 without using the device 1 of the present invention. The medical container 100 typically includes a barrel 108 defining a reservoir containing the medical fluid and a distal tip 102 defining a passageway in fluid communication with the reservoir. The medical container 100 may be comprised of a stopper 110 and a plunger rod 112 for expelling the medical product through the distal tip 102.

[0029] 1 and 2, add-on device 1 can include a housing 2 defining an internal conduit 20 for circulating a medical product through device 1 from a fluid inlet 22 to a fluid outlet 24. Housing 2 has a proximal end 26 with proximal connection means, such as threads or a collar 262, for connecting device 1 to medical container 100 so that medical fluid contained therein can flow from medical container 100 through fluid inlet 22 to device 1, and a distal end 28 with distal connection means, such as threads 284, for connecting device 1 to connector 200 so that medical fluid can flow from device 1 through fluid outlet 24 to connector 200.

[0030] The device 1 further includes a plug 4 for closing the fluid outlet 24, a slider 5 movable together with the plug 4 between an open position (FIG. 2) in which the plug 4 is positioned away from the fluid outlet 24 and a closed position (FIG. 6) in which the plug 4 closes the fluid outlet 24, an elastic member 7 that biases the slider 5 and the plug 4 toward the open position, and a holder 8 that guides the sliding movement of the slider 5 between the open position and the closed position along a central longitudinal axis A of the device 1.

[0031] 4 to 6, the slider 5 is configured such that the pressure region 50 is disposed in the proximal portion of the medical fluid flow path so that the medical fluid circulating inside the internal conduit 20 applies distal pressure to the pressure region 50. The pressure region 50 is configured such that the medical fluid pressure acting thereon moves the slider 5 and the plug 4 distally against the action of the elastic member 7 towards the closed position.

[0032] As long as the pressure remains below a predetermined threshold, the resilient member 7 keeps the plug 4 away from the fluid outlet 24, and the slider 5 remains in the intermediate position (FIG. 4) and does not reach the closed position. Thus, medical fluid can flow downstream through the connector 200.

[0033] When the pressure equals a predetermined threshold, the distal force exerted on the pressure region 50 overcomes the proximal force of the elastic member 7, thus causing the slider 5 to reach a closed position and the plug 4 to close the fluid outlet 24, thereby preventing the medical fluid from flowing through the connector 200. When the pressure of the medical fluid exerted on the pressure region 50 is equal to or greater than the predetermined threshold, the medical fluid is prevented from flowing through the connector 200.

[0034] The pressure area 50, the predetermined pressure threshold, and the travel distance of the slider 5 between the open position shown in Figure 2 and the closed position shown in Figure 6 can be determined depending on the volume of medical fluid to be injected and / or the dimensions of the medical container 100 (e.g., the inner diameter of the container). For example, the area of ​​the pressure area 50 can be 30 mm 2 and 35mm 2 Between, preferably about 33 mm 2 The predetermined threshold may be between about 25 psi, or 1.7×10 5 Pa and 1.8 x 10 5 Pa. The movement distance of the slider 5 between the open position shown in Fig. 2 and the closed position shown in Fig. 6 can be, for example, about 2 mm.

[0035] The pressure region 50 may be defined by a proximal surface of the disk-shaped actuating member 52 of the slider 5. The pressure region 50 is preferably perpendicular to the longitudinal axis A. As shown in FIG. 4 or FIG. 6, the slider 5, and more specifically the actuating member 52, is configured to allow medical fluid to flow into the internal conduit 20 without blocking it, regardless of the position of the slider 5.

[0036] Thus, the actuating member 52 may include at least one, and preferably two, through-holes 54 that allow the medical fluid to pass through the pressure region 50. The through-holes 54 are preferably symmetrical about a longitudinal plane that includes the central longitudinal axis A, so that the flow of the medical fluid remains symmetrical. In an alternative embodiment not shown, the peripheral edge 56 of the actuating member 52 may include a notch that allows the medical fluid to pass through the slider 5, or more precisely, between the slider 5 and the inner surface of the internal conduit 20.

[0037] The resilient member 7 may be in the form of a bellows. When there is no medical fluid circulating within the device 1, the resilient member 7 maintains the slider 5 and plug 4 in an open position at the proximal end of the slider 5, as shown in Figure 2. However, the resilient member 7 is designed to cause the slider 5 and plug 4 to reach a closed position when the medical fluid pressure exceeds a predetermined threshold.

[0038] The slider 5 includes an axially extending connecting member, such as a connecting rod 58, for connecting the pressure region 50 and 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 part.

[0039] However, referring to Figure 3, the plug 4 may be a separate component that is secured to the connecting member, for example by friction or via an adhesive material. The plug 4 may define a hole 40 for receiving the connecting rod 58 and, if necessary, an adhesive material.

[0040] In the illustrated embodiment, the actuating 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, at the distal end of the connecting rod 58. The elastic member 7 may be disposed around the connecting rod 58. Thus, the connecting rod 58 extends through the elastic member 7.

[0041] 2 and 3, the holder 8 includes 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 rod 58 of the slider 5 such that the rod 58 slides into the inner tubular ring 80.

[0042] It should be noted that the peripheral edge 56 of the slider 5, and more particularly the peripheral edge 56 of the actuating member 52, may be configured to contact the inner wall of the internal passage 20 as the slider 5 moves within the internal passage 20, and this peripheral edge 56 may help to guide the slider 5 along the longitudinal axis A.

[0043] The elastic member 7 has one end supported by the inner tubular ring 80 of the holder 8 and an opposite end that bears against the distal face of the actuating member 52 .

[0044] The holder 8 may include retaining elements, such as radial spokes 82, for connecting the inner tubular ring 80 to the housing 2 without interfering with the flow of medical fluid in the internal conduit 20. The radial spokes 82 thus define through openings 86 for circulation of fluid through the holder 8. The spokes 82 may also be regularly distributed in the circumferential direction.

[0045] 3, the housing 2 may be comprised of an upper housing 30 and a lower housing 32, and the holder 8 may be comprised of an outer ring 84 that may form part of the housing 2. The upper housing 30 may be secured to a proximal surface of the outer ring 84, while the lower housing 32 may be secured to a distal surface of the outer ring 84.

[0046] 7, the proximal connection means and the distal connection means are configured to allow a detachable connection between the device 1 and the medical container 100, and between the device 1 and the connector 200. As such, the device 1 is a separate component that is not integrated with the medical container 100 or the connector 200, and therefore, a medical professional can freely decide whether or not to detach the device 1 as needed.

[0047] The proximal connection means may comprise a female fitting 260, which may be in the form of a tubular portion, configured to tightly receive a corresponding male fitting on the cylindrical or conical distal tip 102 of the medical container 100. Furthermore, the proximal connection means may comprise connection features such as two diametrically opposed outer collars 262 designed to engage with the internal threads 104 of an adapter 106 attached to the distal tip 102 of the medical container 100. The proximal connection means may therefore also be able to cooperate with any standard syringe, such as a 3 mL, 5 mL, or 10 mL syringe, and in particular be able to establish either a luer slip or luer lock connection with the medical container 100.

[0048] 1, 2 and 7, the distal connection means may comprise a male fitting 280, which may be in the form of a cylindrical or conical tubular tip configured to tightly engage with the female fitting 202 of the connector 200. The distal connection means may include a collar 282 with internal threads 284 for engaging corresponding external threads 204 disposed on the female fitting 202 of the connector 200. Thus, the distal connection means is also preferably designed to cooperate with any standard fitting of the connector 200.

[0049] For example, referring to FIG. 4, the internal conduit 20 may be comprised of a first section 20a having a first diameter, a second section 20b distal to the first section 20a and having a second diameter, and a third section 20c 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 or may be smaller than the first diameter. The first and second sections 20a, 20b may be separated by a proximal tapered section 20d. Similarly, the second and third sections 20b, 20c may be separated by a distal tapered section 20e. In the open position of FIG. 2, the actuating member 52 may abut against the proximal tapered section 20d. In the closed position, the plug 4 may abut against the distal tapered section 20e. In the intermediate position (FIG. 4), the pressure region 50 and the plug 4 may be located away from the tapered sections 20d, 20e.

[0050] 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 holder 8. For example, the plug 4 and / or the elastic member 7 may be formed of a rubber or silicone material. The housing 2, the slider 5, and / or the holder 8 may be made of polypropylene or polycarbonate. In one embodiment, the plug 4, the elastic member 7, the slider 5, the holder 8, and the housing 2, 28 may be made by injection molding.

[0051] Referring to FIG. 2, the plug 4 may include a distal tapered portion 42 for sealing the fluid outlet 24 .

[0052] The operation of the device 1 will now be described with reference to Figures 2, 4, 5, and 6. When there is no medical fluid circulating inside the device 1 (Figure 2), the elastic member 7 maintains the slider 5 in a position corresponding to the closest position of the slider 5. The plug 4 is located away from the fluid outlet 24.

[0053] When a user presses the plunger rod 112 of the medical container 100 to inject medical fluid, distal pressure is applied to the pressure region 50 (arrow 51 on FIG. 5 ). This distal pressure pushes the slider 5 distally, thereby compressing the elastic member 7. As long as the fluid pressure acting on the pressure region 50 is below a predetermined threshold, the elastic member 7 maintains the slider 5 in an open position (FIG. 4 ) intermediate between the open position of FIG. 2 and the closed position of FIG. 6 . The plug 4 remains away from the fluid outlet 24 (see arrow 240) so that the medical fluid can flow through the fluid outlet 24 toward the connector 200.

[0054] When the fluid pressure exerted on the pressure region 50 reaches or exceeds a predetermined threshold, the distal force exerted on the actuation member 52 overcomes the proximal force of the resilient member 7 such that the slider 5 is further moved distally until it reaches a closed position, causing the plug 4 to close the fluid outlet 24 (FIG. 6). Thus, medical fluid is blocked inside the device 1 and cannot flow through the connector 200. Therefore, the medical professional injecting the medical product must reduce the pressure exerted by their finger on the plunger rod 112 to pursue the injection.

[0055] When the fluid pressure exerted on pressure area 50 decreases and again falls below the predetermined threshold, resilient member 7 urges slider 5 back toward the open position (FIG. 2 or FIG. 4). Plug 4 moves proximally from fluid outlet 24, again allowing medical fluid to exit device 1 and circulate within connector 200.

[0056] 7, the present invention further relates to a medical container 100, such as a pre-filled or pre-fillable syringe, including a barrel 108 defining a reservoir containing a medical product, a distal tip 102 defining a passageway in fluid communication with the reservoir, and the aforementioned device 1 connected to the distal tip 102. The medical container 100 may comprise a plunger 110 and a plunger rod 112 for expelling the medical product via the distal tip 102. The medical container 100 preferably includes an adapter 106 attached to the distal tip 102, the adapter 106 including connection means, such as internal threads 104, that engage with proximal connection means provided on the proximal end of the device 1 to secure the connection.

[0057] The device of the present invention can also be connected to a connector 200 of a needle hub or vascular access device, such as an intravenous (IV) catheter, more particularly a peripheral intravenous (PIV) catheter, etc. In this manner, the device 1 is connected to a female fitting 202 of the connector 200. This female fitting 202 preferably has connection means, such as external threads 204, that engage with a threaded collar 282 of the device 1 to secure the connection. The device 1 may further be connected to a medical container 100.

[0058] The present invention also relates to a method for manufacturing the device 1 described above, said method comprising the steps of: step (i) of assembling the holder 8, the slider 5, the elastic member 7, and the plug 4; (ii) fixing the holder 8 to the lower housing 32, preferably by ultrasonic welding; and (iii) fixing the holder 8 to the upper housing 30, preferably by ultrasonic welding.

[0059] 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 holder 8. The plug 4 may then be fixed to the slider 5, for example by adhesive.

[0060] Thus, the device 1 of the present invention provides an easily attachable add-on configuration that can control injection and / or injection pressure. The device 1 prevents catheter blockage and blood vessel damage. The device 1 is versatile because it can be used with any syringe, catheter, needle, or NFC (needle-free connection) device. Additionally, medical personnel can disable the pressure control function by simply disconnecting the device 1.

Claims

1. A device (1) for fluidly connecting a medical container (100) containing a medical fluid to a connector (200), comprising: a housing (2) defining an internal conduit (20) for circulating a medical fluid from a fluid inlet (22) to a fluid outlet (24); a slider (5) disposed within the internal conduit (20) and movable along a central longitudinal axis (A) between an open position, in which medical fluid is permitted to flow through the fluid outlet (24), and a closed position, in which medical fluid is prevented from flowing through the fluid outlet (24), the slider (5) including a connecting rod (58) extending along the central longitudinal axis (A), the connecting rod (58) connecting an actuating member (52) and a plug (4); the plug (4) connected to the slider (5), the plug (4) configured to close the fluid outlet (24) when the slider (5) is in a closed position; an elastic member (7) disposed proximal to the plug (4) and configured to exert a proximal force on the slider (5), the elastic member (7) maintaining the slider (5) in an open position; a proximally oriented pressure region (50) on the actuation member (52) of the slider (5), configured to cause the slider (5) to reach a closed position against the action of the elastic member (7) and thereby cause the plug (4) to close the fluid outlet (24) when medical fluid pressure exerted on the pressure region (50) is equal to or greater than a predetermined threshold; 1. A device (1) comprising: a holder (8), the holder (8) including 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) connecting the guide element (80) to the outer ring (84), the retaining element (82) such that the retaining element (82) defines an opening (86) that allows medical fluid to flow through the holder (8).

2. 2. The device of claim 1, wherein the actuating member (52) includes a peripheral edge (56) configured to guide 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 medical fluid to pass through the actuating member (52).

3. The device of claim 2 , wherein the at least two through holes ( 54 ) are symmetrical about a longitudinal plane containing the central longitudinal axis A.

4. 4. The device according to any one of claims 1 to 3, wherein the actuating member (52) has a disk shape.

5. 5. The device of claim 1, wherein the pressure region (50) is orthogonal to the central longitudinal axis A.

6. 6. The device of any one of claims 1 to 5, wherein 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 part.

7. 7. The device according to any one of claims 1 to 6, wherein the elastic member (7) is a bellows extending around the connecting rod (58).

8. 8. Device according to any one of the preceding claims, wherein the elastic member (7) extends between the actuating member (52) and the guide element (80) of the holder (8).

9. 9. The device according to claim 1, wherein the housing (2) comprises an upper housing (30) and a lower housing (32), and the outer ring (84) of the holder (8) forms an intermediate housing (2) part interposed between the upper and lower housings (30, 32).

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

11. The medical container (100) includes a reservoir for containing a medical fluid; A medical container (100), wherein the device (1) according to any one of claims 1 to 10 is fluidly 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: Assembling the holder (8), the slider (5), the elastic member (7), and the plug (4); fixing the holder (8) to the lower housing (32); and securing said holder (8) to said upper housing (30).

13. A method as described in claim 12, wherein the step of fixing the holder (8) to the lower housing (32) is performed by ultrasonic welding.

14. A method as described in claim 12, wherein the step of fixing the holder (8) to the upper housing (30) is performed by ultrasonic welding.

Images