Two-way valve, two-way valve assembly and PICC conduit

Abstract

This invention relates to a bidirectional valve, a bidirectional valve assembly, and a PICC catheter. The bidirectional valve includes: a pressure-response section comprising a first pressure-response area and a second pressure-response area, wherein the first pressure-response area has a first slit, and the second pressure-response area has a second slit. The first slit is configured to open at least under a first pressure, and the second slit is configured to open at least under a second pressure. The first pressure is less than the second pressure, and the direction of the first pressure is opposite to the direction of the second pressure. A fixing section is also provided circumferentially along the pressure-response section. The bidirectional valve provided in this application is used for inserting a central venous catheter via a peripheral vein. Different opening pressures are set for opening slits on different structures. Under a certain pressure response, the bidirectional valve assembly valve plate opens in the forward direction, effectively performing fluid infusion; under a larger reverse pressure response, the bidirectional valve assembly valve plate opens in the reverse direction, effectively performing blood aspiration. The structure is simple and easy to reshape.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a bidirectional valve, a bidirectional valve assembly, and a PICC catheter. Background Technology

[0002] Peripherally inserted central venous catheters (PICCs) are widely used in clinical practice as an important access route for tumor chemotherapy and parenteral nutrition due to their high success rate, simple and safe operation, long indwelling time, and few complications. However, with the widespread use of PICCs, reports of complications such as catheter occlusion, mechanical phlebitis, and thrombosis are increasing. Among these, catheter occlusion and thrombosis caused by blood or drug reflux are the more serious complications.

[0003] There are three main types of PICCs currently available on the market: front-end tri-valve PICCs, full-access PICCs, and rear-end valve PICCs. Due to their inherent structural limitations, each type has its own defects and shortcomings. Front-end tri-valve PICCs are primarily made of silicone rubber, which is not strong enough and prone to breakage. The valves in polyurethane catheters are located inside the blood vessel, making high-pressure infusion difficult and resulting in low infusion efficiency. Full-access PICCs, generally made of polyurethane, can achieve high-pressure infusion compared to front-end tri-valve PICCs. However, because they lack valves, air can easily enter the fluid line, causing complications such as thrombosis. Using clamps can alleviate these problems to some extent, but the clamp's application point is prone to catheter breakage and incomplete sealing, leading to new risks and significantly limiting their use. Rear-end valve PICCs combine the advantages of the first two types and are a promising option. However, existing products often have complex valve structures, leading to instability during infusion and blood aspiration, further limiting their use. Summary of the Invention

[0004] Therefore, it is necessary to provide a two-way valve, a two-way valve assembly, and a PICC catheter to address the problem of unstable infusion and blood aspiration caused by the complex structure of PICC catheters.

[0005] A two-way valve includes a pressure response section, comprising: a first pressure response region and a second pressure response region, wherein the first pressure response region has a first slit and the second pressure response region has a second slit, the first slit is configured to open at least under a first pressure and the second slit is configured to open at least under a second pressure, wherein the first pressure is less than the second pressure and the direction of the first pressure is opposite to the direction of the second pressure; and a fixing portion is disposed circumferentially along the pressure response section.

[0006] Furthermore, the second pressure response region is arranged circumferentially along the first pressure response region, or the second pressure response region is arranged on both sides of the first pressure response region, the first slit is arranged in the middle of the pressure response part, and 2n second slits are arranged on the second pressure response region symmetrically with respect to the first slit, and the material hardness of the first pressure response region is less than that of the second pressure response region.

[0007] Furthermore, the first pressure response region protrudes outward along the first pressure direction.

[0008] Furthermore, the material of the first pressure response region has a Shore hardness of less than 50A, and the material of the second pressure response region has a Shore hardness of greater than 55A.

[0009] Furthermore, the first pressure response region includes a valve plate, the valve plate having a protrusion in the middle that protrudes outward along the first pressure direction, the first slit being formed on the protrusion, and the second pressure response region including a groove formed on the valve plate, the groove being recessed inward along the second pressure direction, and the second slit being formed on the bottom wall of the groove.

[0010] Furthermore, the groove is disposed on the protrusion, the first slit and the second slit at least partially overlap, and the first slit and the second slit communicate the bottom wall of the groove and the bottom surface of the valve plate.

[0011] Furthermore, the second pressure response region also includes a recessed region that is concave along the second pressure direction, the groove being disposed within the recessed region, and the radius of curvature of the recessed region being smaller than the radius of curvature of the protrusion.

[0012] Furthermore, the grooves are disposed on both sides of the protrusion, and the length of the first slit is greater than the length of the second slit.

[0013] Furthermore, the grooves are symmetrically arranged on both sides of the protrusion, and the outer contours of the two grooves are on the same circumference in the direction perpendicular to the second pressure, with the center of the circumference located on the first slit.

[0014] Furthermore, there are multiple grooves, and the multiple grooves are arranged circumferentially around the protrusion of the first pressure response area.

[0015] Furthermore, the shape of the second slit includes one or more combinations of right angles, I-shapes, and straight lines.

[0016] Furthermore, the first pressure response region includes a valve plate, one side of which has a protrusion that bulges outward along the first pressure direction, and the first slit is formed on the protrusion. The second pressure response region includes a groove formed on the other side of the valve plate, the groove being recessed inward along the second pressure direction, and the second slit being formed on the bottom wall of the groove.

[0017] Furthermore, the length of the first slit is greater than the length of the second slit.

[0018] Furthermore, the lengths of the first slit and the second slit are both at least 0.2 mm longer than the length of the groove, and the first slit and the second slit do not contact the fixing part.

[0019] Furthermore, the length of the first slit is at least 0.2 mm longer than the length of the protrusion, and the first slit and the second slit do not contact the fixing part.

[0020] Furthermore, the first pressure is less than half of the second pressure.

[0021] Furthermore, the materials of the first pressure response zone and the second pressure response zone include one or more of butyl rubber, styrene-butadiene rubber, ethylene propylene diene monomer (EPDM) rubber, fluorosilicone rubber, and liquid silicone rubber.

[0022] Furthermore, the Shore hardness of the material of the bidirectional valve is between 40A and 75A.

[0023] Furthermore, the bidirectional valve is integrally injection molded.

[0024] This application also provides a bidirectional valve assembly, including the bidirectional valve described above, and further including a first housing having a first inner cavity for communicating with the first slit and the second slit of the bidirectional valve, the diameter of the first inner cavity gradually decreasing along the first pressure direction; a second housing having a second inner cavity for communicating with the first slit and the second slit of the bidirectional valve, the diameter of the second inner cavity gradually decreasing along the second pressure direction; the second housing, the bidirectional valve and the first housing are arranged sequentially along the first pressure direction.

[0025] Furthermore, the materials of the first housing and the second housing include one or more of polycarbonate, acrylonitrile-butadiene-styrene copolymer, polypropylene, polyethylene, polystyrene, polymethyl methacrylate, polyethylene terephthalate, and methyl methacrylate-butadiene-styrene copolymer.

[0026] Furthermore, a PICC catheter is provided, including the bidirectional valve assembly described above, and also including a guidewire, the bidirectional valve assembly including a guidewire orifice for the guidewire to pass through.

[0027] Furthermore, it also includes a main pipe, which is made of medical polyurethane material through an extrusion process. The main pipe is divided into a variable diameter pipe section and a non-variable diameter pipe section.

[0028] Furthermore, it also includes a suture wing connected to the reducing pipe portion, the suture wing having through holes on both sides for fixing the main pipe to the body surface.

[0029] The bidirectional valve provided in this application is used for inserting a central venous catheter via a peripheral vein. Through the coordination of a first pressure response zone and a second pressure response zone, slits are set in the first and second pressure response zones. Opening slits on different structures requires matching different pressures. Under a certain pressure response, the first slit of the bidirectional valve opens, effectively allowing fluid infusion; under a greater reverse pressure response, the second slit of the bidirectional valve opens, effectively allowing blood aspiration; when no pressure is applied, the first and second slits of the bidirectional valve remain closed. The valve features a simple structure, ingenious design, and easy reconfiguration. It provides stable fluid infusion and blood aspiration processes and effectively prevents bleeding and reduces the probability of complications such as thrombosis, demonstrating promising application prospects. Attached Figure Description

[0030] Figure 1 This is a perspective view of the bidirectional valve according to Embodiment 1 of this application;

[0031] Figure 2 This is a cross-sectional view of the bidirectional valve according to Embodiment 1 of this application;

[0032] Figure 3 This is a perspective view of the bidirectional valve according to Embodiment 2 of this application;

[0033] Figure 4 This is a cross-sectional view of the two-way valve according to Embodiment 2 of this application;

[0034] Figure 5 This is a perspective view of the bidirectional valve according to Embodiment 3 of this application;

[0035] Figure 6 This is a cross-sectional view of the bidirectional valve according to Embodiment 3 of this application;

[0036] Figure 7 This is a perspective view of the bidirectional valve according to Embodiment 4 of this application;

[0037] Figure 8 This is a cross-sectional view of the bidirectional valve according to Embodiment 4 of this application;

[0038] Figure 9 This is a perspective view of the bidirectional valve according to Embodiment 5 of this application;

[0039] Figure 10This is a cross-sectional view of the two-way valve according to Embodiment 5 of this application;

[0040] Figure 11 This is a perspective view of the bidirectional valve of Embodiment Six of this application;

[0041] Figure 12 This is a cross-sectional view of the bidirectional valve assembly according to Embodiment Seven of this application;

[0042] Figure 13 This is an exploded view of a PICC catheter according to Embodiment 8 of this application.

[0043] Among them, 1, fixed part, 2, pressure response part, 21, first pressure response area, 211, valve plate, 212, protrusion, 22, second pressure response area, 3, groove, 4, first slit, 4', second slit, 5, recessed area, 6, first slit, 6', second slit, 7, slit;

[0044] 10. First housing; 101. Inner cavity of the first housing; 20. Two-way valve; 30. Second housing;

[0045] 40. Two-way valve assembly; 50. Extension tube; 60. Stitching wing; 61. Through hole; 70. PICC main body tube; 71. Stitching wing end reducer section. Detailed Implementation

[0046] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0047] In the description of this invention, it should be understood that the terms "center," "length," "lateral," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0048] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0049] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0050] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0051] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0052] First, this application claims protection for a two-way valve, which includes at least: a pressure response part 2 and a fixing part 1. The pressure response part 2 includes a first pressure response area 21 and a second pressure response area 22. A first slit 4 is provided on the first pressure response area 21, and a second slit 4' is provided on the second pressure response area 22. The first slit 4 is configured to open at least under a first pressure, and the second slit 4' is configured to open at least under a second pressure. The first pressure is less than the second pressure, and the direction of the first pressure is opposite to the direction of the second pressure. The fixing part 1 is arranged circumferentially along the pressure response part 2.

[0053] Figure 1 A perspective view of the bidirectional valve according to Embodiment 1 of this application is shown. Figure 2 A cross-sectional view of a two-way valve according to Embodiment 1 of this application is shown, in conjunction with... Figure 1 , Figure 2 As shown, the bidirectional valve provided in this application includes a fixing part 1 and a pressure response part 2. The fixing part 1 is arranged circumferentially along the pressure response part 2. The fixing part 1 is used to support the pressure response part 2, and at the same time, the bidirectional valve can be fixedly connected to other components through the fixing part 1. The pressure response part 2 includes a first pressure response area 21 and a second pressure response area 22. A first slit 4 is provided on the first pressure response area 21, and a second slit 4' is provided on the second pressure response area 22. The first slit 4 is configured to open at least under the action of a first pressure, and the second slit 4' is configured to open at least under the action of a second pressure. The first pressure is less than the second pressure, and the direction of the first pressure is opposite to the direction of the second pressure.

[0054] Specifically, the first pressure response zone 21 includes a valve plate 211, with a protrusion 212 in the middle of the valve plate 211 that protrudes outward along the first pressure direction AA. The bottom of the valve plate 211 forms a hemispherical cavity for containing the infused liquid. A first slit 4 is formed on the protrusion 212 of the valve plate 211. The second pressure response zone 22 includes a groove 3 formed on the valve plate 211. The groove 3 is recessed inward along the second pressure direction BB. A second slit 4' is disposed on the bottom wall of the groove 3. In this embodiment, the first slit 4 and the second slit 4' coincide and connect the hemispherical cavity and the groove 3. The first pressure direction AA is opposite to the second pressure direction BB. Because the groove 3 is located in the middle of the valve plate 211, that is, at the highest point of the protrusion 212, the protrusion 212 and the groove 3 on the valve plate 211 are arranged facing each other so that the first slit 4 and the second slit 4' partially overlap. The first slit 4 and the second slit 4' connect the bottom wall of the groove 3 and the bottom surface of the valve plate 211, thus facilitating the opening of the first slit 4 and the second slit 4'. Furthermore, the first slit 4 and the second slit 4' are located at the thinnest part of the valve plate 211, making it easy to open in response to pressure, forming channels for infusion and blood aspiration. The first slit 4 and the second slit 4' penetrate the pressure response part 2. When the first pressure acts on the pressure response part 2 along the AA direction, the first slit 4 and the second slit 4' open to achieve infusion; when the second pressure acts on the pressure response part 2 along the BB direction, the second slit 4' and the first slit 4 open to achieve blood aspiration. Since the first pressure along the AA direction has a large curved surface with the help of the protrusion 212, it is easier to respond to deformation and open the first slit 4 and the second slit 4' compared with a flat surface. In this embodiment, the curved surface area of ​​the protrusion 212 is larger than that of the groove 3. Therefore, the first pressure required to open the first slit 4 on the protrusion 212 is smaller than the second pressure required to open the second slit 4' on the groove 3, which meets the user's need to open the infusion fluid channel and the blood aspiration channel by adjusting the pressure of different magnitudes.

[0055] Optionally, in Embodiment 1, the groove 3 extends along the length of the first slit 4 or the second slit 4', with the first slit 4 and the second slit 4' located in the middle of the groove 3, corresponding to the thinnest position of the valve plate 211, making the two sides of the groove 3 symmetrical about the first slit 4 and the second slit 4'. Optionally, the bottom wall shape of the groove 3 is arc-shaped, right-angled, acute-angled, or obtuse-angled, etc. With this structure, only a small first pressure is needed to open the first slit 4 in the first pressure direction AA, ensuring smooth infusion; while a larger second pressure is needed to open the second slit 4' in the second pressure direction BB, thereby completing the blood aspiration action. It should be noted that the magnitude of the first pressure and the second pressure can be adjusted by the length of the first slit 4 and the second slit 4', as well as the structure of the pressure response unit 2 and the groove 3.

[0056] Optionally, the valve plate 211 of the two-way valve is composed of one or more of the following materials: butyl rubber, styrene-butadiene rubber, ethylene propylene diene monomer (EPDM) rubber, fluorosilicone rubber, and liquid silicone rubber, preferably liquid silicone rubber.

[0057] Optionally, the material hardness of the two-way valve is in the range of Shore hardness from 35A to 95A, preferably from 40A to 75A.

[0058] Alternatively, the two-way valve can be manufactured by integral injection molding.

[0059] Figure 3 A perspective view of the bidirectional valve according to Embodiment 2 of this application is shown. Figure 4 A cross-sectional view of the bidirectional valve according to Embodiment 2 of this application is shown. The description of the valve plate in Embodiment 2 and the following embodiments is similar to that in Embodiment 1, and therefore will not be repeated. The difference between Embodiment 2 and Embodiment 1 is that the second pressure response region 22 in Embodiment 2 further includes a recessed region 5. The recessed region 5 is concave in the second pressure direction BB, and the groove 3 is disposed within the recessed region 5. The recessed region 5 and the protrusion 212 have different radii of curvature, thereby giving the valve plate 211 different curved arc surfaces on both sides. Optionally, the radius of curvature of the recessed region 5 is smaller than that of the protrusion 212, and the arc surface area of ​​the protrusion 212 is larger than that of the recessed region 5. With this structure, the thickness of the pressure response part 2 can be reduced, thereby opening the first slit 4 or the second slit 4' thereon with less pressure.

[0060] Optionally, the projection shape of the groove 3 on the plane perpendicular to the second pressure direction BB can be elliptical or olive-shaped, and the depth of the groove 3 is half or more of the thickness when the groove 3 is not provided at that location.

[0061] Optionally, the length of the first slit 4 is at least 0.2 mm longer than the length of the groove 3 itself.

[0062] Figure 5 A perspective view of the bidirectional valve according to Embodiment 3 of this application is shown. Figure 6A cross-sectional view of the bidirectional valve according to Embodiment 3 of this application is shown. The difference between Embodiment 3 and Embodiment 1 is that in Embodiment 3, the second pressure response zone 22 is located on both sides of the protrusion 212. The first slit 6 on the protrusion 212 and the second slit 6' on the groove 3 are separately arranged. That is, the first slit 6 is opened at the protrusion 212 of the first pressure response zone 21, and grooves 3 are respectively opened on the second pressure response zone 21. The grooves 3 are arranged on both sides of the protrusion 212, and the two grooves 3 are symmetrical relative to the first slit 6. Optionally, the first slit 6 is located at the center of the first pressure response zone 21 and extends through the entire pressure response section 2. A second slit 6' is opened on each groove 3, and the second slit 6' also extends through the entire pressure response section 2, thereby allowing liquid to pass through the pressure response section 2. The lengths of the first slit 6, the second slit 6', and the grooves 3 extend in the same direction, and the length of the first slit 6 is greater than the length of the second slit 6'.

[0063] Optionally, the grooves 3 are symmetrically arranged on both sides of the first slit 6, and the grooves 3 are symmetrically arranged on both sides of the protrusion 212. The outer contours of the two grooves 3 in the direction perpendicular to the second pressure are on the same circumference, and the center of the circumference is located on the first slit. It can be understood that the outer contour of the aforementioned groove 3 refers to the structural shape of the section farthest from the first slit 6 at the junction of the groove 3 and the valve plate 211 body. This section of the junction adopts an arc-shaped design. This design allows the groove 3 to have a large arc surface, thereby ensuring the function of blood aspiration. When infusion is performed, it is done through the first slit 6 located in the middle, while when blood aspiration is required, it is done through the second slits 6' located on both sides. Compared with the case where infusion and blood aspiration use partially overlapping slits, this pressure-response bidirectional valve structure allows infusion and blood aspiration to pass through different paths, which is beneficial to the operator and improves the product life.

[0064] Furthermore, the shape of the protrusion 212 of the first pressure response region 21 on the projection plane perpendicular to the second pressure direction BB can be elliptical, olive-shaped or other approximate configuration.

[0065] Furthermore, the length of the first slit 6 is greater than the length of the second slits 6' on both sides. The length of the slit has a great influence on the magnitude of the response pressure. The longer first slit 6 can ensure that the pressure response bidirectional valve assembly does not have much resistance when performing liquid infusion, while the shorter second slits 6' enable it not only to have the function of drawing back blood, but also to effectively prevent blood leakage.

[0066] Figure 7 A perspective view of the bidirectional valve according to Embodiment 4 of this application is shown. Figure 8A cross-sectional view of the bidirectional valve according to Embodiment 4 of this application is shown. Embodiment 4 is similar to Embodiment 3 in that the first slit 6 on the first pressure response zone 21 and the second slit 6' on the groove 3 in Embodiment 4 do not overlap. In Embodiment 3, the grooves 3 are symmetrically distributed on both sides of the protrusion 212 of the first pressure response zone 21. In Embodiment 4, the protrusion 212 and the groove 3 on the valve plate 211 are respectively located on both sides of the pressure response section 2. The groove 3 is disposed on the second pressure response zone 22. The protrusion 212 has the first slit 6, and the groove 3 has the second slit 6'. The arc surface area of ​​the protrusion 212 in the first pressure response zone 21 is larger than the arc surface area of ​​the groove 3, thereby ensuring that the second pressure used for blood aspiration is greater than the first pressure used for infusion.

[0067] Furthermore, the shapes of the protrusion 212 and the groove 3 on the projection plane perpendicular to the second pressure direction BB include, but are not limited to, olive-shaped, oblong, or elliptical.

[0068] Figure 9 A perspective view of the bidirectional valve according to Embodiment 5 of this application is shown. Figure 10 A cross-sectional view of a bidirectional valve according to Embodiment 5 of this application is shown. In the bidirectional valve shown in Embodiment 5, a first slit 6 is provided at the protrusion 212 of the first pressure response zone 21. Multiple grooves 3 are distributed circumferentially around the protrusion 212 of the first pressure response zone 21. A second slit 6' is provided on each groove 3. Optionally, the grooves 3 can be arranged in an array, with a quantity of four. The shape of the second slit 6' on the groove 3 includes, but is not limited to, a right angle, a straight line, or an I-shape. That is, when viewed from the second pressure direction BB, the planar structure of the second slit 6' on the groove 3 is a right angle, a straight line, or an I-shape, thus giving the second slit 6' multiple openings. This structure fully utilizes the product's spatial structure and, by arranging multiple second slits 6', effectively improves the efficiency of blood aspiration.

[0069] It should be noted that in the above embodiments, when the first slit and the second slit are not coincident, both the first slit and the second slit penetrate the pressure response section, thereby allowing the liquid located on both sides of the pressure response section to flow.

[0070] Figure 11This is a perspective view of the bidirectional valve according to Embodiment Six of this application. The difference between Embodiment Six and the previous embodiments is that the first pressure response zone 21 and the second pressure response zone 22 on the bidirectional valve in Embodiment Six are made of materials with different Shore hardnesses, so that different pressures are required when the first slit 6 and the second slit 6' open. Specifically, the second pressure response zone 22 is arranged circumferentially along the first pressure response zone 21, or the second pressure response zone 22 is arranged on both sides of the first pressure response zone 21. The Shore hardness of the material of the first pressure response zone 21 is less than that of the material of the second pressure response zone 22. The first pressure response zone 21 protrudes outward in the first pressure direction AA, and a first slit 6 is provided on it. The first slit 6 is located in the middle of the pressure response section 2. 2n (n is a positive integer) second slits 6' are symmetrically arranged on the second pressure response zone 22 relative to the first slit 6. The length of the first slit 6 is greater than the length of the second slit 6'. The first pressure response zone 21 is configured to apply a first pressure along the first pressure direction AA to open the first slit 6, and the second pressure response zone 22 is configured to apply a second pressure along the second pressure direction BB to open the second slit 6'. The aforementioned n is a positive integer, and the number of second slits 6' is an even number.

[0071] Furthermore, the tangent of the second slit 6' can be perpendicular to the plane where the second pressure response zone 22 is located, or the second slit 6' can be opened at a certain angle to the plane where the second pressure response zone 22 is located. The size of the angle, the length of the slit, and the number of slits are used to adjust the pressure used to open the slit.

[0072] Optionally, the material hardness of the first pressure response zone 21 is less than 80% of the material hardness of the second pressure response zone 22. The hardness of the first pressure response zone 21 ensures low resistance during liquid infusion, while the higher hardness of the second pressure response zone 22 requires a certain pressure to activate, thus avoiding the possibility of spurting and improving safety during use. Optionally, the Shore hardness of the material in the first pressure response zone 21 is less than 50A, and the Shore hardness of the material in the second pressure response zone 22 is greater than 55A.

[0073] Furthermore, the thickness of the second pressure response zone 22 is less than 0.5 mm.

[0074] In conjunction with the above embodiments, the bidirectional valve provided in this application may optionally have a slit length between 3mm and 6mm. Its constituent materials include one or more of butyl rubber, styrene-butadiene rubber, ethylene propylene diene monomer (EPDM) rubber, fluorosilicone rubber, and liquid silicone rubber, with a Shore hardness between 40A and 75A.

[0075] In all the above embodiments, the first pressure is preferably less than half of the second pressure.

[0076] Furthermore, since the material rigidity of the fixing part is greater than that of the pressure response part, it is preferable that the first slit and the second slit do not contact the fixing part 1, thereby preventing the first slit and the second slit from opening without being subjected to the first pressure and the second pressure, and preventing air leakage from occurring in the bidirectional valve assembly.

[0077] In another embodiment of this application, the length of the first slit is determined by the length, width, and depth of the groove and the hardness of the elastic material. Preferably, the length of the first slit exceeds the length of the groove by at least 0.2 mm.

[0078] The bidirectional valve provided in this application is used for inserting a central venous catheter via a peripheral vein. Through the coordination of a first pressure response zone and a second pressure response zone, slits are set in both zones, and different opening pressures are applied to the slits on different structures. Under a certain pressure response, the first slit of the bidirectional valve opens, effectively allowing fluid infusion; under a greater reverse pressure response, the second slit opens, effectively allowing blood aspiration; without applying a certain pressure, the bidirectional valve remains closed. It features a simple structure, ingenious design, and easy reconfiguration. The fluid infusion and blood aspiration processes are stable, and it can effectively prevent bleeding and reduce the probability of complications such as thrombosis, showing promising application prospects.

[0079] Secondly, this application also protects a bidirectional valve assembly having the bidirectional valves of the foregoing embodiments. Figure 12 A cross-sectional view of a bidirectional valve assembly according to Embodiment 7 of this application is shown. The bidirectional valve assembly provided in this application includes a first housing 10, a bidirectional valve 20, and a second housing 30. The first housing 10 and the second housing 30 are respectively connected to both sides of the bidirectional valve 20. The first housing 10 has a first inner cavity 101 for communicating with a first slit and a second slit of the bidirectional valve 20. The diameter of the first inner cavity 101 gradually decreases along the first pressure direction AA, forming a first interface 102, thereby making the first inner cavity 101 of the first housing 10 form a funnel-shaped structure. When the bidirectional valve 20 deforms under the first pressure, the first... The first inner cavity 101 of the housing 10 can suppress its drastic deformation and help the two-way valve 20 to quickly return to its original state when the first pressure is removed; the second housing 30 has a second inner cavity 301 for communicating with the first slit and the second slit of the two-way valve 20. The diameter of the second inner cavity 301 gradually decreases along the second pressure direction BB to form a second interface 302. The working principle of the second inner cavity 301 is similar to that of the first inner cavity 301. The two-way valve 20 is disposed between the first inner cavity 101 and the second inner cavity 301; the second housing 30, the two-way valve 20 and the first housing 10 are arranged sequentially along the first pressure direction AA.

[0080] Furthermore, the first housing 10 and the second housing 30 are made of medical plastic materials, including but not limited to polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS), polypropylene (PP), polyethylene (PE), polystyrene (PS), polymethyl methacrylate (PMMA), polyethylene terephthalate (PET), and methyl methacrylate-butadiene-styrene copolymer (MBS), and the molding method includes but is not limited to injection molding or machining.

[0081] Finally, this application also protects a PICC (peripherally inserted central venous catheter) with the aforementioned bidirectional valve assembly, wherein the valve plate is provided with a slit to facilitate guidewire passage, and the guidewire is used to guide the PICC tube to complete the insertion. One embodiment is to use... Figure 1 In the first embodiment shown, the slit for passing through the guidewire coincides with the first slit 4 on the pressure response section 2; for another embodiment, see [reference needed]. Figure 7 In the fourth embodiment shown, the slit 7 for the guidewire passage is located at the center of the first pressure response zone 21, while the first slit 6 and the second slit 6' are respectively distributed on both sides of the slit 7. Normally, the slit 7 is relatively narrow and only used for guidewire insertion, without significant deformation, and therefore does not generate a pressure response, thus not affecting infusion or blood aspiration. Therefore, those skilled in the art can combine different valve plate implementations to set appropriate guidewire insertion slits.

[0082] Figure 13 An exploded view of the PICC catheter according to Embodiment 8 of this application is shown. The bidirectional valve assembly 40 includes a first housing 10, a bidirectional valve 20, and a second housing 30. The second housing 30 has a Luer connector, mainly used to connect other medical components for infusion or blood aspiration. 50 is an extension tube, facilitating observation of the medication and blood return during use. Optionally, the extension tube 50 is transparent; 60 is a suture wing with through holes 61 on both sides, mainly used to cooperate with the catheter fixation device to fix the PICC to the body surface. 70 is the main PICC tubing, made of medical polyurethane material through an extrusion process. The main tubing can be mainly divided into a variable diameter section 71 near the suture wing end and a non-variable diameter section. The use of the variable diameter section helps improve the flexural strength of the tubing. Furthermore, the peripherally inserted central venous catheter also includes a guidewire, which passes through the pressure-responsive bidirectional valve assembly 40, guiding the PICC catheter through insertion.

[0083] It should be noted that the technical effects of the bidirectional valve assembly and the peripherally inserted central venous catheter applicable to the bidirectional valve assembly are similar to the technical effects of the bidirectional valve provided in this application, and therefore will not be described in detail.

[0084] All of the above solutions can be used in combination, and are not limited to independent solutions. The specific shape of the groove, the length of the slit, and the thickness of the valve plate can be adjusted according to the actual situation. In addition, this application is not limited to PICC, but can also be used in CVC (central venous catheter placement) or other medical devices that require pressure response.

[0085] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0086] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A two-way valve, characterized in that, include: The pressure response unit includes a first pressure response area and a second pressure response area. The first pressure response area is provided with a first slit, and the second pressure response area is provided with a second slit. The first slit is configured to open at least under a first pressure, and the second slit is configured to open at least under a second pressure. The first pressure is less than the second pressure, and the direction of the first pressure is opposite to the direction of the second pressure. as well as The fixing part is arranged circumferentially along the pressure response part; The first pressure response region includes a valve plate, and the first slit is formed on the valve plate. The second pressure response region includes a groove, and the second slit is disposed on the bottom wall of the groove. The first slit and the second slit are located at the thinnest part of the valve plate. The valve plate has a protrusion that bulges outward along the first pressure direction in the middle. The first slit is formed on the protrusion. The groove is recessed inward along the second pressure direction. The second pressure response region also includes a recessed region that is recessed inward along the second pressure direction. The groove is disposed in the recessed region. The radius of curvature of the recessed region is smaller than the radius of curvature of the protrusion.

2. The bidirectional valve according to claim 1, characterized in that, The second pressure response zone is arranged circumferentially along the first pressure response zone, or the second pressure response zone is arranged on both sides of the first pressure response zone; The first slit is located in the middle of the pressure response section, and 2n second slits are provided on the second pressure response region symmetrical to the first slit. The material hardness of the first pressure response region is less than that of the second pressure response region.

3. The bidirectional valve according to claim 2, characterized in that, The first pressure response region bulges outward along the first pressure direction.

4. The bidirectional valve according to claim 2, characterized in that, The Shore hardness of the material in the first pressure response region is less than 50A, and the Shore hardness of the material in the second pressure response region is greater than 55A.

5. The bidirectional valve according to claim 1, characterized in that, The groove is disposed on the protrusion, the first slit and the second slit at least partially overlap, and the first slit and the second slit connect the bottom wall of the groove and the bottom surface of the valve plate.

6. The bidirectional valve according to claim 1, characterized in that, The grooves are disposed on both sides of the protrusion, and the length of the first slit is greater than the length of the second slit.

7. The bidirectional valve according to claim 6, characterized in that, The grooves are symmetrically arranged on both sides of the protrusion, and the outer contours of the two grooves are on the same circumference in the direction perpendicular to the second pressure, with the center of the circumference located on the first slit.

8. The bidirectional valve according to claim 2, characterized in that, The number of grooves is multiple, and the multiple grooves are arranged circumferentially around the protrusion of the first pressure response area.

9. The bidirectional valve according to claim 8, characterized in that, The shape of the second slit includes one or more combinations of right angle, I-shape, and straight line.

10. The bidirectional valve according to claim 1, characterized in that, The first pressure response region includes a valve plate, one side of which has a protrusion that bulges outward along the first pressure direction, and the first slit is formed on the protrusion. The second pressure response region includes a groove formed on the other side of the valve plate, the groove being recessed inward along the second pressure direction, and the second slit being formed on the bottom wall of the groove.

11. The bidirectional valve according to claim 10, characterized in that, The length of the first slit is greater than the length of the second slit.

12. The bidirectional valve according to claim 1 or 5, characterized in that, The lengths of the first slit and the second slit are both at least 0.2 mm longer than the length of the groove, and the first slit and the second slit do not contact the fixing part.

13. The bidirectional valve according to any one of claims 7-11, characterized in that, The length of the first slit is at least 0.2 mm longer than the length of the protrusion, and the first slit and the second slit do not contact the fixing part.

14. The bidirectional valve according to any one of claims 1-11, characterized in that, The first pressure is less than half of the second pressure.

15. The bidirectional valve according to any one of claims 1-11, characterized in that, The materials of the first pressure response zone and the second pressure response zone include one or more of butyl rubber, styrene-butadiene rubber, ethylene propylene diene monomer (EPDM) rubber, fluorosilicone rubber, and liquid silicone rubber.

16. The bidirectional valve according to claim 15, characterized in that, The material of the bidirectional valve has a Shore hardness between 40A and 75A.

17. The bidirectional valve according to any one of claims 1-11, characterized in that, The bidirectional valve is manufactured by integral injection molding.

18. A bidirectional valve assembly comprising the bidirectional valve according to any one of claims 1-17, characterized in that, Also includes: A first housing has a first inner cavity for communicating with the first slit and the second slit of the bidirectional valve, the diameter of the first inner cavity gradually decreasing along the first pressure direction; The second housing has a second inner cavity for communicating with the first slit and the second slit of the bidirectional valve, the diameter of the second inner cavity gradually decreasing along the second pressure direction; The second housing, the bidirectional valve, and the first housing are arranged sequentially along the first pressure direction.

19. The bidirectional valve assembly according to claim 18, characterized in that, The materials of the first housing and the second housing include one or more of polycarbonate, acrylonitrile-butadiene-styrene copolymer, polypropylene, polyethylene, polystyrene, polymethyl methacrylate, polyethylene terephthalate, and methyl methacrylate-butadiene-styrene copolymer.

20. A PICC catheter comprising the bidirectional valve assembly of claim 18 or 19, characterized in that, It also includes a guide wire, and the bidirectional valve assembly includes a guide wire hole for the guide wire to pass through.

21. The PICC catheter according to claim 20, characterized in that, It also includes the main pipe, which is made of medical polyurethane material through an extrusion process. The main pipe is divided into a variable diameter pipe section and a non-variable diameter pipe section.

22. The PICC catheter according to claim 21, characterized in that, It also includes a suture wing connected to the reducing tube portion, the suture wing having through holes on both sides for fixing the main tube to the body surface.

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