Improved one-way valve device for an infusion line or medical device that allows fluid circulation through the infusion line at low pressure

Abstract

A one-way valve device for a medical fluid line, configured to allow fluid flow in only one direction and block fluid flow in the opposite direction, includes a valve body having an inlet portion (3) and an outlet portion (4), each of which has a tubular connector (5, 6) for connection to a medical fluid line, and an elastic valve body (8) disposed within the valve body (2) so as to block fluid flow and allow fluid flow in only one direction through the valve body (2) when the fluid exceeds a predetermined pressure value. The elastic valve body (8) is flat and has a central region (35) from which two arms (36) protrude symmetrically and are held by the inlet and outlet portions (3, 4) of the valve body (2).

Description

[Technical Field]

[0001] The present invention relates to a one-way valve arrangement or "check valve" for medical infusion lines or medical devices as set out in the preamble of the independent claims. [Background technology]

[0002] Valve devices of the type described above have been used for many years in medical infusion lines or medical devices used in medical infusion lines where medical fluids to be administered to a patient, such as blood, saline or normal saline, typically flow intravenously.

[0003] These valve devices are broadly classified into two types: valve devices (also simply referred to as "valves") that close when backflow occurs in the medical infusion line (i.e., fluid flows in the opposite direction to the desired direction in the medical infusion line), and valve devices that open when flow occurs in the forward direction (i.e., the desired direction in the medical infusion line). The former type of valve device is called a "normally open" type, while the latter type of valve device is called a "normally closed" type. These valve devices include a valve body with an internal duct fitted with a connector for connection to the medical infusion line. A one-way valve element is located between the internal ducts.

[0004] The present invention relates to a valve device, i.e. a normally closed valve, having a valve body that provides a normally closed connection between an internal duct of a valve body.

[0005] For the latter type of valve ("one-way valve" or "check valve") to open, the fluid circulating in the attached medical infusion line or in the medical device placed in the medical infusion line must have a pressure equal to or higher than that of a typical valve, known as the "opening pressure" (also called the "cracking pressure"). This opening pressure value must usually be kept as low as possible, which requires the provision of a valve device with a more complex mechanism than that of a valve that opens at a higher opening pressure. However, this complexity affects the valve device's ability to prevent backflow at pressures higher than that resisted by the valve device with a high opening pressure.

[0006] U.S. Patent Publication No. 2008 / 0169444 discloses a valve device with a one-way valve for medical infusion lines, which includes a one-way valve formed of a diaphragm made of an elastic material disposed between a first portion and a second portion of a valve body having a tubular connector. The diaphragm is cup-shaped, and its outer peripheral edge is normally in close contact with a valve seat having a conical surface due to an axial thrust applied by the side wall of the cup-shaped diaphragm. In this configuration, pressure applied by backflow in the medical infusion line is used to apply a pressing force to the side wall of the cup-shaped diaphragm, helping to maintain intimate contact with the valve seat.

[0007] U.S. Patent No. 5,992,462 discloses a valve device with a one-way valve that includes a valve body having a base and a cup portion nested within each other, with an end chamber of the base received in a corresponding cup-shaped portion of the cup portion. A disk-shaped valve element made of an elastic material is disposed within the valve body and has flat surfaces on both sides. The valve element has a central spherical portion and is captured between opposing valve supports supported by the cup portion and the base, respectively. These valve supports utilize deformation of the elastic valve element to seal the inlet side of the valve body.

[0008] Another prior art document, U.S. Patent Publication No. 2011 / 0108147, discloses a valve device having a valve body composed of a first section and a second section with a connecting pipe. The valve body includes a one-way valve and a disk-shaped diaphragm between the first and second sections. The disk-shaped diaphragm has annular protrusions protruding from both sides. The annular protrusions are configured to be received in opposing annular grooves in opposing valve body components. The disk-shaped diaphragm is thus fixed to the valve body along its periphery. The disk-shaped diaphragm has a plurality of radially extending openings. The protrusions on the fluid inlet side of the valve body tightly contact the valve seat within the valve body through the non-opening portions of the disk-shaped diaphragm. During use, the inflowing fluid first passes through the openings in the disk-shaped diaphragm, and when the fluid pressure exceeds a predetermined value, the tight contact ceases.

[0009] The sealing of the disc-shaped diaphragm on the valve body is caused by radially symmetric forces that stress the disc-shaped diaphragm and cooperate with the wall of the valve seat. In fact, the annular protruding ridges housed in the respective grooves pre-tension the disc-shaped diaphragm, forcing it against the valve seat and sealing it tightly against the valve seat.

[0010] U.S. Patent Publication No. 2021 / 093780 discloses a backflow prevention device including a housing, a trap flow section that forms a medical fluid flow path, and a discharge section that is provided at the bottom of the housing and receives the medical fluid from the trap flow section and discharges the medical fluid. A backflow prevention chamber section is provided between the trap flow section and the discharge section. A plate-shaped backflow prevention member is provided on one inner surface of the backflow prevention chamber section connected to the trap flow section, in close contact with the periphery of the outlet opening. The plate-shaped backflow prevention member is provided to open or close the opening depending on the forward flow or reverse flow of the medical fluid.

[0011] The plate-shaped backflow prevention member is hinged on one side to the fixed member of the housing, and on one side the plate-shaped backflow prevention member is provided with a hole suitable for receiving the guide protrusion protruding from the housing part.

[0012] Thus, when the flow of medical fluid passes through the backflow prevention device toward the patient, the backflow prevention member rotates about the fixed portion and the second end of the backflow prevention member moves along the guide protrusion, allowing the flow of medical fluid to pass through the backflow prevention device.

[0013] Conversely, in the event of backflow, the backflow prevention member is pressed against the opening of the inlet passage in the body of the backflow prevention device, preventing backflow.

[0014] This prior art document does not disclose a "two-stage one-way valve" that can withstand high flow rates and open under low pressure conditions after excessive tension in the backflow prevention member incorporated in the housing, which occurs due to the shape of the one-way valve disc. In fact, due to the way the backflow prevention member is coupled to the housing, it restricts movement of the backflow prevention member due to fluid passing through the inlet passage. Due to frictional forces that arise at least between the backflow prevention member and the guide protrusion, movement of the backflow prevention member to properly move fluid is only possible after the frictional force exceeds a threshold value. At that point, the backflow prevention member allows fluid to flow freely through the trapped flow section only after the threshold value is reached and exceeded.

[0015] U.S. Patent Publication No. 2011 / 034907 describes a body fluid drainage system including a urinary catheter, a urine collection bag, and a connecting member connected between the urinary catheter and the urine collection bag. The connecting member is formed of a sheet material and houses a valve body protruding from a sealing surface. The valve body extends longitudinally between a connecting portion and a flap portion, and a recess is formed around the valve body between the connecting portion and the flap.

[0016] Within the connecting member, the valve disc is hinged to a portion of the connecting section and rotates about the hinge.

[0017] More specifically, the valve body is provided within the connector of the body fluid drainage system and is simpler to operate than the backflow prevention member disclosed in U.S. Patent Publication No. 2021 / 093780. Indeed, the valve body has a lateral connection portion with internal mating means adapted to mate with a retaining means of the first part of the connector of the body fluid drainage system. The valve body has a flap portion integral with the connection portion, which moves within the connector to open or close the flow through the connector.

[0018] Therefore, US Patent Publication No. 2011 / 034907 describes a solution in which proper operation of the valve element occurs when the pressure of the inlet flow exceeds a set threshold, opening the valve element, due to the way the valve element is connected to the first part of the connector of the body fluid drainage system.

[0019] European Patent Publication No. 1099455 discloses a check valve for an IV line or the like. The check valve for an IV line or the like includes a diaphragm formed from an elastic material inserted between first and second tubular connectors and operating with an annular valve seat that keeps the check valve normally closed. The diaphragm has an annular peripheral portion and a central disk portion connected to the annular peripheral portion via a torus with spaced arms. The central disk portion is molded with a thin, axially protruding peripheral seal edge on one or both sides. While the annular valve seat surrounds the tip of the inlet passage of the check valve body, the central disk portion acts as a valve closure. When fluid pressure in the inlet passage exceeds a predetermined threshold, the central disk portion of the diaphragm separates from the valve seat, allowing fluid to pass through the check valve toward the outlet passage. When backflow occurs, the fluid pressure in the outlet passage presses the valve disc against the valve seat, preventing backflow.

[0020] In this prior art solution, the valve closure opens when the fluid in the inlet passage rises above the valve seat threshold. Summary of the Invention [Problem to be solved by the invention]

[0021] The object of the present invention is to provide a valve arrangement with a one-way valve or check valve for medical infusion lines or for medical devices used in medical infusion lines, which is an improvement over similar one-way valves already known.

[0022] In particular, it is an object of the present invention to provide a one-way valve assembly of the type described above which opens the one-way valve element at the lowest possible fluid pressure while effectively preventing backflow from the medical fluid line back into the one-way valve in all cases.

[0023] In accordance with the above objectives, the present invention provides a one-way valve device that is conveniently operable to open under low pressure conditions to allow small amounts of fluid flow into a medical infusion line.

[0024] Another object of the present invention is to provide a one-way valve device of the above type which has as few parts as possible and can be manufactured in a short time and at low cost. [Means for solving the problem]

[0025] The above objects, and other objects which will become apparent to those skilled in the art, are achieved by a one-way valve arrangement as claimed. [Brief explanation of the drawings]

[0026] To facilitate understanding of the invention, the following drawings are attached, which illustrate non-limiting embodiments only.

[0027] [Figure 1] 1 is a perspective view of a one-way valve device according to the present invention; [Figure 2] 2 is an exploded perspective view of the one-way valve device shown in FIG. 1 as viewed from one side. FIG. [Figure 3] 2 is an exploded perspective view of the one-way valve device shown in FIG. 1, as viewed from the other side. FIG. [Figure 4] 2 is an exploded front view of the one-way valve device shown in FIG. 1 with some components being transparent. [Figure 5] 2 is an enlarged perspective view of one of the components of the one-way valve device shown in FIG. 1 before assembly. [Figure 6] FIG. 2 is a top view of the one-way valve device shown in FIG. [Figure 7] FIG. 7 is a cross-sectional view taken along line 7-7 in FIG. 6. [Figure 8] FIG. 8 is a cross-sectional view taken along line 8-8 in FIG. 6. [Figure 9] FIG. 8 is an enlarged view of a portion indicated by the symbol A in FIG. 7. [Figure 10] FIG. 9 is an enlarged view of the area indicated by the symbol B in FIG. 8. [Figure 11] FIG. 10 is a perspective view of another embodiment of a one-way valve device according to the present invention, as seen from one side. [Figure 12] FIG. 12 is an exploded perspective view of the one-way valve device shown in FIG. 11 as viewed from one side. [Figure 13] 12 is an exploded perspective view of the one-way valve device shown in FIG. 11 as viewed from the other side. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0028] Referring to the above-mentioned accompanying drawings, a valve device equipped with a one-way valve (check valve) is generally designated by the reference numeral 1. The valve device 1 has a valve body 2 including a first portion 3 and a second portion 4, each of which is equipped with known tubular connectors 5 and 6 configured to connect the valve body 2 to a tube of a medical fluid line (not shown) or to the main body of a medical device placed in the medical fluid line (e.g., a filter placed in an intravenous infusion line, etc.). The first portion 3 and the second portion 4 are formed with recesses 7 around the tubular connectors 5 and 6, respectively, to facilitate connection to the tubular connectors.

[0029] 1 to 4, arrows F and H indicate the direction of fluid flow inside and outside the valve body 2.

[0030] Within the valve box 2, a valve component, or valve disc 8, is disposed between the first section (i.e., inlet section) 3 and the second section (i.e., outlet section) 4, with the internal ducts 10 and 11 connected to the tubular connectors 5 and 6, respectively. The valve disc 8 is formed of an elastic material and is configured to block the connection between the internal ducts 10 and 11 when the pressure of the fluid in the medical fluid line at the inlet section 3 drops below a predetermined value, e.g., 0.05 psi or 0.0034 bar. When a higher pressure than the predetermined pressure is applied, the valve disc 8 elastically deforms, opening the internal ducts 10 and 11 to allow the medical fluid, such as saline or blood component solution, to pass through the valve box 2 and the two connectors. However, the valve disc 8 closes the connection between the internal ducts 11, thereby preventing the medical fluid from flowing back from the outlet section to the inlet section. In this way, the valve disc functions as a one-way valve.

[0031] More specifically, the internal ducts 10 and 11 of the valve body 2 open at faces 3A and 4A of the inlet and outlet sections 3 and 4, respectively. These faces face each other and contact each other. The faces 3A and 4A are formed on raised portions 15 and 16 of the inlet and outlet sections 3 and 4, respectively. These raised portions 15 and 16 are located on the inner sides of the inlet and outlet sections 3 and 4 within the valve body 2. The valve disc 8 is located between the raised portions 15 and 16. In the embodiment shown in FIGS. 1 to 10, the raised portions 15 and 16, when connected, form an annular or peripheral recess 19 that receives a thermoplastic material during the overmolding process. The inlet and outlet sections 3 and 4 are overmolded after the valve disc 8 is assembled between the inlet and outlet sections 3 and 4 (with faces 3A and 4A in contact). The inlet portion 3 and the outlet portion 4 are joined together by overmolding to form the completed valve body 2.

[0032] The inner duct 10 opens into a transverse recess 23 at 10A, i.e., so that the longitudinal axis K of the transverse recess is perpendicular to the longitudinal axis W of the valve body 2 (see FIG. 3 ), resulting in a central hollow circular region 24. From either side of the central hollow circular region, hollow side regions 25 extend in a substantially rectangular shape toward the peripheral recess 19. The inner duct 10 opens into the central hollow circular region 24 at 10A. For example, as can be seen in FIGS. 7-10 , the opening 10A of the inner duct 10 is substantially conical, widening toward the central hollow circular region 24 and perpendicular to the longitudinal axis K of the transverse recess, with the transverse direction of the hollow side region being defined within the rectangular hollow side region by protrusions 26 and 27 on either side of the inner duct opening 10.

[0033] Additionally, hollow side region 25 includes the aforementioned protrusions 26 and 27 and increases in depth toward end 25F of hollow side region near annular peripheral recess 19. End 25F of hollow side region is defined by a stepped edge 28 at its end.

[0034] Similarly, the internal duct 11 opens at 11A into an oval or elliptical recess 30 (having a major axis parallel to the longitudinal axis K) formed in the outlet portion 4. The oval or elliptical recess opens at face 4A of the outlet portion. Within oval or elliptical recess 30 are a number of protrusions 31, the function of which will be explained later, directed towards face 4A. The oval or elliptical recess 30 has an arrangement perpendicular to the arrangement of protrusions 26 and 27.

[0035] Furthermore, at the hollow side region 25 of the inlet-side portion 3, a plurality of protrusions 33 are provided from the surface 4A toward the hollow side region 25. The protrusions are wedge-shaped, decreasing in height toward the oval or elliptical recess 30 (at or near the edge 30A of the oval or elliptical recess the protrusions are broken) and increasing in height toward each end 33B of the protrusions facing the annular peripheral recess 19. Each end 33B facing the annular peripheral recess terminates in a stepped edge 38 near a corresponding recess 34 formed in the surface 4A.

[0036] The cross-sectional recess 23 is provided with a valve element 8 above the projection 33, which is formed substantially to follow the shape of the cross-sectional recess 23. To this end, the valve element 8 has a central portion 35 with rounded edges (hereinafter referred to as "circular"), from which branch off two arms 36, each of which terminates at its free end with an end flange 37 projecting perpendicularly from each side surface 36A, 36B of the arm.

[0037] When the valve body is not assembled into the valve box 2, it is substantially flat, with the central portion 35 and its arms 36 being on the same plane, or as in the embodiment shown in Figures 11 to 13, the central portion 35 (which is flat) is located on a first plane, but the arms are located on a different second plane that is very close to and parallel to the first plane.

[0038] More specifically, a central portion 35 of the valve body 8 is positioned in the central hollow circular region 24 of the first part transverse recess 23, and the opposing arms 36 of the valve body are configured to rest on protrusions 26 and 27 formed in the transverse recess. The central portion 35 of the valve body is positioned opposite the protrusion 31.

[0039] Both side arms 36 of the valve body 8 are positioned on the wedge-shaped protrusions 33 and have end flanges 37 perpendicular to the both side arms 36, which engage and mate with the stepped edges 28 and 38 described above. Furthermore, the central portion 35 of the valve body 8 closes the connection between the internal ducts 10 and 11 when it is not subjected to fluid pressure in the internal ducts.

[0040] Furthermore, due to the engagement of the end flange 37 and the stepped edges 28 and 38, the disc continues to be under tension along the opposing arms 36, i.e., along axis K (arrow X in FIG. 5 ). Tension along axis W of the disc is caused by the disc's contact with the projections 33 and the protrusions 26 and 27. This tension clearly arises when the valve body 2 is assembled and overmolded with a thermoplastic material that forms portion 40 within the annular peripheral recess 19. The thermoplastic material and overmolding securely and permanently assemble the three parts of the valve device (first portion 3, second portion 4, and disc 8) and seal the entire periphery of the annular member 8. However, the disc of the present invention is not affected by this overmolding and remains free to move within the valve body 2, functioning as a one-way valve, and opening only when the pressure of the medical fluid entering the valve body 2 from the inner duct 10 exceeds a predetermined pressure.

[0041] The tension within the valve body is perpendicular to the flow direction (the direction that allows passage, i.e., the forward direction) of the medical fluid passing through the valve device (i.e., along the axis W of the valve body 2) and is axially aligned with the backflow of the medical fluid, i.e., the flow moving in the direction opposite to arrow H from the medical fluid line through the internal duct 11 back to the valve body 2.

[0042] When the pressure of the medical fluid entering the inner duct 10 exceeds a predetermined, but fairly low, value, the circular edge of the central portion 35 of the valve body that is not entirely parallel to the lines of tension along both arms 36 (and also along the part of the central portion 35 that faces in the same direction as the arms) is raised by the protrusions described above, allowing a small amount of medical fluid to flow around the one-way valve body 8. This results in a forward flow of medical fluid between the inner ducts 10 and 11 (see Figures 6 to 10).

[0043] As the pressure of the medical fluid increases, the central portion 35 of the valve body is forced to flex fully toward the oval or elliptical recess 30, allowing increased flow of medical fluid between the inner ducts 10 and 11. This flexing is limited by the protrusions 31 in the oval or elliptical recess 30.

[0044] Thus, the valve device according to the present invention operates as a two-stage one-way valve depending on the pressure value of the circulating fluid.

[0045] In fact, when the circulating fluid is at a first pressure, i.e., a low pressure, the degree of opening of the valve element is limited, and when the pressure of the circulating fluid exceeds a pressure higher than the first pressure (e.g., higher than 0.07 bar), the valve element is fully open.

[0046] This two-stage operation is also made possible by the shape of the transverse recess 23, which changes depth towards the end, i.e. towards the annular peripheral recess 19, allowing the valve disc to deform and increase the flow rate between the inner ducts 10 and 11.

[0047] The valve device that can be manufactured according to the present invention ensures the necessary unidirectional flow of medical fluid between the internal duct 10 of the inlet section 3 and the internal duct 11 of the outlet section 4. The valve device is capable of opening under low pressure conditions (e.g., values ​​equal to 0.05-0.07 psi or 0.0034-0.0048 bar) and can handle high pressure flows that occur following an excess of tension within the valve disc 8, which increases depending on the shape of the valve disc 8 and its mating to the valve body 2.

[0048] At the same time, the valve body 8 reliably closes communication between the internal ducts 10 and 11 described above against backflow of medical fluid, i.e. against fluid moving in the opposite direction to that required for medical use within the medical fluid line in which the valve device 1 is incorporated.

[0049] The components of the valve device 1 may be manufactured by molding according to the embodiment shown in Figures 1 to 10, and the manufactured parts may be assembled by overmolding the thermoplastic material forming the valve device portion 40. It should be noted that to facilitate positioning of the joined first and second parts 3 and 4 (with the valve body 8 therebetween) in the mold for overmolding, the first and second parts 3 and 4 have a plurality of flat outer surfaces.

[0050] 11 to 13 show different embodiments of the valve device 1 than those described above, in which elements corresponding to elements already described are given the same reference numerals.

[0051] The main difference between the configuration shown in FIGS. 11 to 13 and the configuration shown in FIGS. 1 to 10 is that the first portion 3 and the second portion 4 are connected by ultrasonic bonding.

[0052] To this end, one of the first and second parts 3 and 4 (first part 3 in the accompanying drawings) comprises a recess 80 around an inner region 15 that is outwardly bounded by a peripheral edge 81 of the one part, while the other part (second part 4 in the accompanying drawings) comprises a wall 82 that extends around the inner region 16, the wall 82 being configured to fit into the recess 80.

[0053] In assembly, after combining the wall 82 and the recess 80, ultrasonic bonding is performed between the first part 3 and the second part 4 while the wall 82 and the recess 80 are still combined, thereby reliably connecting the first part 3 and the second part 4.

[0054] The above describes a preferred embodiment of the present invention. Other embodiments are possible, for example, the first part 3 and the second part 4 may be interchanged. Such embodiments are also subject to the present invention, and their structural features fall within the scope of protection defined in the claims.

Claims

1. 1. A one-way valve device for a medical device configured to be installed in a medical fluid line or in a medical fluid line, comprising: the valve device (1) is configured to allow fluid flow in one direction only and prevent fluid flow in the opposite direction within the medical fluid line or the medical device; The valve device (1) comprises a valve body (2) having an inlet side portion (3) and an outlet side portion (4); Each of the inlet portion (3) and the outlet portion (4) is provided with a connector member (5, 6) for connection to the medical fluid line or the medical device; The connector members (5, 6) are connected to ducts (10, 11) within the valve body (2); Between the internal ducts (10, 11) is provided a one-way valve body (8) disposed on a valve seat (23) in the valve box (2); The one-way valve body (8) is made of an elastic material, the one-way valve (8) comprises a convex central region (35) from which arms (36) diverge symmetrically in opposite directions, The arms extend elongately along a common longitudinal axis (K); the flared central region (35) of the valve body (8) connects with the elongated arms at rounded ends; the central protruding region is provided between the internal ducts (10, 11) of the valve body (2) to prevent or allow communication between the internal ducts (10, 11); a valve seat (23) having a shape that matches the shape of the valve element (8) that is held in tension by the valve seat, the valve seat (33) includes protrusions (26, 27) on which the opposing elongated arms (36) rest; the projections (26, 27) are disposed perpendicular to the longitudinal axes (K) of the oppositely extending elongated arms; The arms (36) extending elongately in opposite directions to each other are provided in the valve body (2) and positioned between a protrusion (33) facing the protrusion (26, 27) of the valve seat and the protrusion (26, 27).

2. 2. The one-way valve device according to claim 1, wherein the protrusions (26, 27) are provided on one of the inlet side portion (3) and the outlet side portion (4), and the protrusion (33) is provided on the other of the inlet side portion (3) and the outlet side portion (4).

3. 2. The one-way valve device according to claim 1, wherein the convex central region (35) of the valve body (8) is circular and the opposing elongated arms (36) project symmetrically from the convex central region (35).

4. 2. A one-way valve arrangement according to claim 1, characterized in that the valve body (8) is flat.

5. 2. The one-way valve device according to claim 1, wherein the opposingly extending elongated arms (36) have opposite side surfaces (36A, 36B) and end flanges (37) at each free end thereof, the end flanges projecting perpendicular to the opposite side surfaces (36A, 36B).

6. 6. A one-way valve arrangement according to claim 5, characterized in that the end flanges mate with end stepped edges (28, 38) of the valve seat (23).

7. The valve seat (23) comprises a transverse recess formed in an inner region (15) of at least one of the inlet portion (3) and the outlet portion (4) of the valve body (2); A corresponding one of the internal ducts (10, 11) of the valve body (2) opens into the transverse recess, the valve seat (27) comprises a central hollow area (24) into which the corresponding internal duct (10 or 11) opens, the central hollow area (24) being adapted to accommodate the protruding central area (35) of the valve body (8), and hollow elongated areas (25) provided laterally relative to the central hollow area (24) and adapted to accommodate the opposing elongated arms (36) of the valve body (8), 6. A one-way valve device according to claim 1 or 5, characterized in that the hollow elongated region (25) terminates in a stepped end edge (28) which mates with the end flanges (34) of the opposing elongated arms (36).

8. 8. A one-way valve arrangement according to claim 7, characterized in that the protrusions (26, 27) provided in the valve seat (23) are provided on both sides of the central hollow area (24).

9. an oval or elliptical recess (30) is provided in the inner region (16) of the other of the inlet side portion (3) and the outlet side portion (4) of the valve body; the oval or elliptical recess (30) faces a central hollow area (24) of the transverse recess (23) formed in one of the inlet and outlet portions (3, 4); a protrusion (33) is provided between the inlet portion (3) and the outlet portion (4) laterally of the oval or elliptical recess, facing the hollow elongated region (25) of the transverse recess (23); The protrusion is wedge-shaped, with one end pointing downward toward the egg-shaped or elliptical recess, 8. The one-way valve device according to claim 7, wherein the other end of the projection defines a stepped edge of the inner region (16) that engages with corresponding end flanges (34) of opposing elongated arms (36) of the valve body.

10. 8. A one-way valve arrangement according to claim 7, characterized in that the hollow elongated regions (25) increase in depth moving away from the central hollow region (24).

11. 10. The one-way valve device according to claim 7 or 9, characterized in that the inner regions (15, 16) of the inlet-side portion (3) and the outlet-side portion (4) are raised at each inner region, and when the inlet-side portion (3) and the outlet-side portion (4) are joined, the inner regions form an annular peripheral recess (19) in the valve body (2).

12. 12. The one-way valve device according to claim 11, characterized in that the annular peripheral recess has portions made of thermoplastic material overmolded onto the inlet portion (3) and the outlet portion (4).

13. 2. The one-way valve device according to claim 1, wherein the inlet portion (3) and the outlet portion (4) are ultrasonically bonded.

14. 14. The one-way valve device according to claim 13, wherein one of the inlet portion (3) and the outlet portion (4) comprises an internal recess (80) configured to receive an internal wall (82) of the other of the inlet portion (3) and the outlet portion (4), the other internal wall (82) being ultrasonically bonded into the internal recess (80).

15. the other internal wall (82) is formed around the other internal region (16) of the inlet-side portion (3) and the outlet-side portion (4); 15. The one-way valve device according to claim 7, 9 or 14, characterized in that the internal recess (80) is provided between the internal region (15) of the one of the inlet side portion (3) and the outlet side portion (4) and the one peripheral edge (81) of the inlet side portion (3) and the outlet side portion.

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