WO2023005226A1

WO2023005226A1 - Two-way valve, two-way valve assembly, and picc

Info

Publication number: WO2023005226A1
Application number: PCT/CN2022/081669
Authority: WO
Inventors: 吴正飞; 顾伊楠; 吴洪远; 刘通通
Original assignee: 上海微创生命科技有限公司
Priority date: 2021-07-27
Filing date: 2022-03-18
Publication date: 2023-02-02
Also published as: CN115671492A

Abstract

A two-way valve, a two-way valve assembly, and a peripherally inserted central catheter (PICC). The two-way valve (20) comprises a fixed part (1) and a pressure response part (2), and the fixed part (1) is arranged along the circumference of the pressure response part (2). The pressure response part (2) comprises a first pressure response area (21) and a second pressure response area (22). The first pressure response area (21) is provided with a first slit (4), the second pressure response area (22) is provided with a second slit (4'), the first slit (4) is configured to at least open under the action of a first pressure, and the second slit (4') is configured to at least open under the action of a second pressure, the first pressure being less than the second pressure, and a first pressure direction being opposite to a second pressure direction. The two-way valve (20) is used to place a central venous catheter through a peripheral vein, and different opening pressures are set for slits on different structures to open; and the structure is simple and reshaping is easy.

Description

Two-way valves, two-way valve assemblies, and PICC catheters

technical field

The invention relates to the technical field of medical instruments, in particular to a two-way valve, a two-way valve assembly and a PICC catheter.

Background technique

As an important access for tumor chemotherapy and parenteral nutrition, peripherally inserted central catheter (PICC) has been widely used clinically because of its high puncture success rate, simple and safe operation procedure, long indwelling time and few complications. application. However, with the widespread application of PICC, there are more and more reports on complications such as catheter blockage, mechanical phlebitis, and thrombosis, among which catheter blockage and thrombosis caused by blood or drug reflux are more serious complications.

There are three main types of PICCs on the market, namely front-end three-way valve PICCs, full-channel PICCs, and rear-end valve pad PICCs. Due to their own structural limitations, they all have their own defects and deficiencies. For the three-way valve PICC at the front end, the catheter is mainly made of silicone rubber material, which is not strong enough and is easy to break the tube, while the catheter made of polyurethane material, the valve is located in the blood vessel, it is difficult to achieve high-pressure infusion, and the infusion efficiency is low; For access PICC, the catheter is generally made of polyurethane material. Compared with the front-end three-way valve PICC, it can achieve high-pressure infusion, but because it has no valve, it is easy for air to enter the fluid line, causing complications such as thrombosis. To a certain extent, the problems caused by it can be alleviated, but the position of the clamp is prone to breakage of the conduit and incomplete sealing, which leads to new risks and greatly limits its use; the back-end valve pad PICC combines the advantages of the first two types of PICC The advantage is that it is a PICC with good application prospects, but the existing product valve pads are often complex in structure, which will cause problems such as instability in the infusion and blood withdrawal process, which also limits its use.

Contents of the invention

Based on this, it is necessary to provide a two-way valve, a two-way valve assembly and a PICC catheter.

In one aspect, the present application provides a two-way valve, including a fixed part and a pressure responsive part, the fixed part is arranged along the circumference of the pressure responsive part, and the pressure responsive part includes a first pressure responsive area and a second pressure responsive area , the first pressure response area is provided with a first slit, the second pressure response area is provided with a second slit, the first slit is configured to be opened at least under the first pressure, the The second slit 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.

On the other hand, the present application provides a two-way valve assembly, which includes the above-mentioned two-way valve, and also includes a first housing and a second housing, the first housing has a first inner cavity, and the first inner The cavity is used to communicate with the first slit and the second slit of the two-way valve, and the diameter of the first inner cavity gradually decreases along the first pressure direction; the second housing has A second inner cavity, the second inner cavity is used to communicate with the first slit and the second slit of the two-way valve, the diameter of the second inner cavity gradually increases along the second pressure direction Decrease; the second housing, the two-way valve and the first housing are sequentially arranged along the first pressure direction.

In yet another aspect, the present application provides a PICC catheter, including the above-mentioned two-way valve assembly, the PICC catheter further includes a guide wire, and the two-way valve assembly includes a guide wire hole for the guide wire to pass through.

Description of drawings

FIG. 1 is a perspective view of a two-way valve according to Embodiment 1 of the present application;

Fig. 2 is a cross-sectional view of the two-way valve of Embodiment 1 of the present application;

FIG. 3 is a perspective view of a two-way valve in Embodiment 2 of the present application;

Fig. 4 is the sectional view of the two-way valve of embodiment 2 of the present application;

FIG. 5 is a perspective view of a two-way valve in Embodiment 3 of the present application;

Fig. 6 is a cross-sectional view of a two-way valve according to Embodiment 3 of the present application;

FIG. 7 is a perspective view of a two-way valve according to Embodiment 4 of the present application;

Fig. 8 is a cross-sectional view of a two-way valve according to Embodiment 4 of the present application;

Fig. 9 is a perspective view of a two-way valve according to Embodiment 5 of the present application;

Fig. 10 is a cross-sectional view of a two-way valve according to Embodiment 5 of the present application;

Fig. 11 is a perspective view of a two-way valve according to Embodiment 6 of the present application;

Fig. 12 is a cross-sectional view of a two-way valve assembly according to Embodiment 7 of the present application;

Fig. 13 is an exploded view of a PICC catheter according to Embodiment 8 of the present application.

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', the second slit, 5, the recessed area, 6, the first slit, 6', the second slit, 7, the slit;

10. The first housing, 101, the cavity of the first housing, 20, the two-way valve, 30, the second housing;

40, two-way valve assembly, 50, extension pipe, 60, suture wing, 61, through hole, 70, PICC main pipe material, 71, suture wing end reducing pipe part.

Detailed ways

In order to make the above objects, features and advantages of the present invention more comprehensible, specific implementations of the present invention will be described in detail below in conjunction with the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, the present invention can be implemented in many other ways different from those described here, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.

In describing the present invention, it should be understood that the terms "center", "length", "transverse", "length", "width", "thickness", "upper", "lower", "front", " Back", "Left", "Right", "Vertical", "Horizontal", "Top", "Bottom", "Inner", "Outer", "Clockwise", "Counterclockwise", "Axial" , "radial", "circumferential" and other indicated orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, which are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying the referred device or Elements must have certain orientations, be constructed and operate in certain orientations, and therefore should not be construed as limitations on the invention.

In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, the features defined as "first" and "second" may explicitly or implicitly include at least one of these features. In the description of the present invention, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

In the present invention, unless otherwise clearly specified and limited, terms such as "installation", "connection", "connection" and "fixation" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection , or integrated; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components or the interaction relationship between two components, unless otherwise specified limit. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.

In the present invention, unless otherwise clearly specified and limited, the first feature may be in direct contact with the first feature or the first and second feature may be in direct contact with the second feature through an intermediary. touch. Moreover, "above", "above" and "above" the first feature on the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is horizontally higher than the second feature. "Below", "beneath" and "beneath" the first feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is less horizontally than the second feature.

It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or intervening elements may also be present. As used herein, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions are for the purpose of illustration only and are not intended to represent the only embodiment.

Figure 1 shows a perspective view of the two-way valve of Embodiment 1 of the present application, and Figure 2 shows a cross-sectional view of the two-way valve of Embodiment 1 of the present application, combined with Figures 1 and 2, the two-way valve provided by the present application includes The fixed part 1 and the pressure response part 2, the fixed part 1 is arranged along the circumferential direction of the pressure response part 2, the fixed part 1 is used to support the pressure response part 2, and at the same time, the two-way valve can be fixedly connected with other components through the fixed part 1; The response part 2 includes a first pressure response area 21 and a second pressure response area 22, the first pressure response area 21 is provided with a first slit 4, the second pressure response area 22 is provided with a second slit 4', and the second pressure response area 22 is provided with a second slit 4'. A slit 4 is configured to open at least under the action of a first pressure, a 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 the same as that of the second pressure. The pressure is in the opposite direction.

Specifically, the first pressure response area 21 includes a valve plate 211. The middle part of the valve plate 211 has a protrusion 212 protruding outward along the first pressure direction A-A. The bottom of the valve plate 211 forms a hemispherical cavity for accommodating Infused fluid. The first slit 4 is set on the protrusion 212 of the valve plate 211, the second pressure response area 22 includes the groove 3 set on the valve plate 211, the groove 3 is concave along the second pressure direction B-B, and the second slit 4' is set on the bottom wall of the groove 3, the first slit 4 in the first embodiment coincides with the second slit 4', and communicates with the hemispherical cavity and the groove 3, the first pressure direction A-A is the same as the second slit 4' The two pressure directions B-B are opposite. Since the groove 3 is arranged 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 opposite to each other so that the first slit 4 and the second slit 4' are partially and the first slit 4 and the second slit 4' communicate with the bottom wall of the groove 3 and the bottom surface of the valve plate 211, so it is convenient to open the first slit 4 and the second slit 4' thereon, and The first slit 4 and the second slit 4' are located at the thinnest part of the valve plate 211, and are easy to open in response to pressure, forming a channel for infusing liquid and withdrawing blood. The first slit 4 and the second slit 4' run through the pressure response part 2, and when the first pressure acts on the pressure response part 2 along the A-A direction, the first slit 4 and the second slit 4' are opened to realize infusion ; When the second pressure acts on the pressure-responsive part 2 along the B-B direction, the second slit 4' and the first slit 4 are opened to achieve blood withdrawal. Since the first pressure along the A-A direction has a larger curved surface by means of the protrusion 212, it is easier to open the first slit 4 and the second slit 4' in response to deformation than the plane, and the protrusion 212 in this embodiment The curved surface area of the groove 3 is larger than that of the groove 3, so 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 , to meet the needs of the user to open the infusion fluid channel and withdraw the blood channel through pressure regulation of different sizes.

Optionally, in Embodiment 1, the groove 3 extends along the length direction of the first slit 4 or the second slit 4', and the first slit 4 and the second slit 4' are located in the middle of the groove 3, Corresponding to the thinnest position of the valve plate 211 , the two sides of the groove 3 are symmetrical about the first slit 4 and the second slit 4 ′. Optionally, the shape of the bottom wall of the groove 3 is arc-shaped, right-angled, acute-angled or obtuse-angled. Through this structure, only a small first pressure is required to open the first slit 4 in the first pressure direction A-A, ensuring the smoothness of infusion; while in the second pressure direction B-B, a larger first pressure is required. Two pressures are required to open the second slit 4', thereby completing the action of withdrawing blood. It should be noted that the magnitudes of the first pressure and the second pressure can be adjusted through the lengths of the first slit 4 and the second slit 4' and the structures of the pressure response part 2 and the groove 3.

Optionally, the composition material of the valve plate 211 of the two-way valve includes but is not limited to one or more of butyl rubber, styrene-butadiene rubber, EPDM rubber, fluorosilicone rubber, and liquid silicone rubber, preferably liquid silicone rubber. rubber.

Optionally, the material hardness of the two-way valve ranges from Shore hardness 35A to 95A, preferably 40A to 75A.

Optionally, the two-way valve is formed by integral injection molding.

Figure 3 shows a perspective view of the two-way valve of the second embodiment of the present application, and Figure 4 shows a cross-sectional view of the two-way valve of the second embodiment of the present application, and the description of the valve plate in the second embodiment and the following embodiments is the same as that of the first embodiment Similar, so I won't make too many statements. The difference between Embodiment 2 and Embodiment 1 is that the second pressure response region 22 in Embodiment 2 also includes a recessed area 5, which is concave inward toward the second pressure direction B-B, and the groove 3 is arranged in the recessed area 5 There are different radii of curvature between the recessed area 5 and the protrusion 212 , so that the two sides of the valve plate 211 have different curved arc surfaces. Optionally, the radius of curvature of the recessed area 5 is smaller than the radius of curvature of the protrusion 212 , and the arc surface area of the protrusion 212 is greater than that of the recess area 5 . With this structure, the thickness of the pressure responsive part 2 can be reduced, so that the first slit 4 or the second slit 4' thereon can be opened with less pressure.

Optionally, the projected shape of the groove 3 on a plane perpendicular to the second pressure direction B-B may be oval or olive-shaped, and the depth of the groove 3 is half or more of the thickness when no groove 3 is provided there.

Optionally, the length of the first slit 4 is at least 0.2 mm greater than the length of the groove 3 itself.

Fig. 5 shows a perspective view of the two-way valve of the third embodiment of the present application, and Fig. 6 shows a cross-sectional view of the two-way valve of the third embodiment of the present application. The difference between the third embodiment and the first embodiment is that the second pressure on the third embodiment The response area 22 is located on both sides of the protrusion 212, and the first slit 6 on the protrusion 212 is set separately from the second slit 6' on the groove 3, that is, opened at the protrusion 212 of the first pressure response area 21 The first slit 6 and the second pressure response area 21 are provided with grooves 3 respectively. The grooves 3 are arranged on both sides of the protrusion 212 . The two grooves 3 are symmetrical to the first slit 6 . Optionally, the first slit 6 is located at the center of the first pressure response area 21 and runs through the entire pressure response portion 2, and each groove 3 is respectively provided with a second slit 6', and the second slit 6' is also It runs through the entire pressure response part 2 , so that the liquid can pass through the pressure response part 2 . The lengths of the first slit 6, the second slit 6' and the groove 3 extend in the same direction, and the length of the first slit 6 is greater than the length of the second slit 6'.

Optionally, the grooves 3 are symmetrically arranged on both sides of the first slit 6, the grooves 3 are symmetrically arranged on both sides of the protrusion 212, and the two grooves 3 are arranged perpendicular to the second pressure. The outer contours in the direction are on the same circle, and the center of the circle is on the first slit. It can be understood that the outer contour of the aforementioned groove 3 refers to the structural shape of the segment farthest from the first slit 6 in the joint between the groove 3 and the valve plate 211 body. This kind of design can make the groove 3 have a larger arc surface, so as to ensure the function of drawing back blood. When infusion is performed, it is carried out through the first slit 6 located in the middle, and when blood needs to be withdrawn, it is carried out through the second slit 6' located on both sides. Compared with infusion and blood withdrawal, partially overlapping slits are used In some cases, the pressure-responsive two-way valve of this structure allows the infusion and withdrawal of blood to pass through different paths, which is beneficial to the operator and improves the product life.

Further, the shape of the projection 212 of the first pressure response area 21 on the projection plane perpendicular to the second pressure direction B-B may be oval, olive or other approximate configurations.

Further, 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 response pressure, and the longer first slit 6 can ensure the pressure response The two-way valve assembly does not have too much resistance during liquid infusion, and the shorter second slit 6' not only has the function of withdrawing blood, but also can well prevent blood from seeping out.

Fig. 7 shows a perspective view of the two-way valve of the fourth embodiment of the present application, and Fig. 8 shows a cross-sectional view of the two-way valve of the fourth embodiment of the present application. The same point between the fourth embodiment and the third embodiment is that the first The first slit 6 on the pressure response area 21 and the second slit 6' on the groove 3 also do not overlap, and the grooves 3 in the third embodiment are symmetrically distributed between the protrusions 212 of the first pressure response area 21 On both sides, while the protrusion 212 and the groove 3 on the valve plate 211 in the fourth embodiment are respectively located on both sides of the pressure response part 2, the groove 3 is arranged on the second pressure response area 22, and the protrusion 212 is provided with The first slit 6 and the groove 3 are provided with a second slit 6'. The arc surface area of the protrusion 212 of the first pressure response area 21 is larger than the arc surface area of the groove 3, thereby ensuring that the second pressure used for withdrawing blood is greater than the first pressure used for infusion.

Further, the shapes of the projection 212 and the groove 3 on the projection plane perpendicular to the second pressure direction B-B include but not limited to olive, oval or ellipse.

Figure 9 shows a perspective view of the two-way valve in Embodiment 5 of the present application, and Figure 10 shows a cross-sectional view of the two-way valve in Embodiment 5 of the present application. In the two-way valve shown in Embodiment 5, the first pressure response area 21 The protrusion 212 is provided with a first slit 6, and the groove 3 includes a plurality of grooves 3 which are circumferentially distributed around the protrusion 212 of the first pressure response area 21, and the groove 3 is provided with a second slit 6 '. Optionally, the arrangement of the grooves 3 includes an array, and the number is four. Wherein, the shape of the second slit 6' on the groove 3 includes, but is not limited to, a right-angle shape, a straight shape, an I-shape, etc., that is, the second slit 6' on the groove 3 is viewed from the second pressure direction B-B, Its planar structure is in the shape of a right angle, a straight line or an I-shaped shape, so that the second slit 6' has multiple openings. With this structure, on the one hand, the spatial structure of the product is fully utilized, and on the other hand, by arranging multiple first slits The second slit 6' can effectively improve the efficiency of drawing back blood.

It should be noted that, in the above embodiments, in the case where the first slit and the second slit are not overlapped, both the first slit and the second slit pass through the pressure response part, so that the pressure response part on both sides liquid to circulate.

Figure 11 is a perspective view of the two-way valve of the sixth embodiment of the present application. The material setting of the Shore hardness makes it necessary to provide different pressures when the first slit 6 and the second slit 6 ′ are opened. Specifically, the second pressure response region 22 is arranged along the circumference of the first pressure response region 21, or the second pressure response region 22 is arranged on both sides of the first pressure response region 21, and the material of the first pressure response region 21 The Shore hardness is smaller than the Shore hardness of the material of the second pressure responsive region 22 . The first pressure response area 21 protrudes toward the first pressure direction A-A, on which there is a first slit 6, the first slit 6 is located in the middle of the pressure response part 2, and the second pressure response area 22 is opposite to the first slit 6. 2n (n is a positive integer) second slits 6' are arranged symmetrically, and the length of the first slit 6 is greater than the length of the second slit 6'. The first pressure response area 21 is configured to apply a first pressure along the first pressure direction A-A to open the first slit 6, and the second pressure response area 22 is configured to apply a second pressure along the second pressure direction B-B to open the second slit. slit 6', the aforementioned n is a positive integer, and 2n second slits 6' means that the number of second slits 6' is an even number.

Further, the tangential direction of the second slit 6' may be perpendicular to the plane where the second pressure response area 22 is located, or the second slit 6' may be formed at a certain angle with the plane where the second pressure response area 22 is located. The size of the slit, the length of the slit and the number of strips are used to adjust the pressure used to open the slit.

Optionally, the hardness of the material of the first pressure response zone 21 is less than 80% of the hardness of the material of the second pressure response zone 22, the hardness of the first pressure response zone 21 can ensure that there is less resistance when the liquid is infused, and the second pressure The response area 22 has relatively high hardness and requires a certain pressure to activate, thereby avoiding the possibility of bleeding and improving the safety during its use. Optionally, the Shore hardness of the material of the first pressure response region 21 is less than 50A, and the Shore hardness of the material of the second pressure response region 22 is greater than 55A.

Further, the thickness of the second pressure response region 22 is less than 0.5mm.

In combination with the above embodiments, the two-way valve provided by the present application, optionally, the length of the slit thereon is between 3 mm and 6 mm. Its constituent materials include one or more of butyl rubber, styrene-butadiene rubber, EPDM rubber, fluorosilicone rubber and liquid silicone rubber, and the Shore hardness of the material is between 40A-75A.

In each of the above embodiments, preferably, the first pressure is less than half of the second pressure.

Further, 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 avoiding that the first slit and the second slit are not subjected to the first slit. It is opened under the condition of the first pressure and the second pressure, so as to avoid the occurrence of air leakage of the two-way valve assembly.

In another embodiment of the present 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 is at least 0.2 mm beyond the length of the groove.

The two-way valve provided by this application is used for inserting a central venous catheter through a peripheral vein. Through the cooperation of the first pressure response area and the second pressure response area, a narrow valve is set on the first pressure response area and the second pressure response area. slit, and set different opening pressures for the opening of slits on different structures. Under a certain pressure response, the first slit of the two-way valve is opened to effectively infuse liquid; under a larger reverse pressure response, the two-way The second slit of the valve is opened to effectively withdraw blood; when a certain pressure is not applied, the two-way valve remains closed. The structure is simple, the concept is ingenious, and the reshaping is easy. The process of infusing liquid and withdrawing blood is stable, and can effectively prevent Oozing blood and reducing the probability of complications such as thrombosis have good application prospects.

Secondly, this application also protects the two-way valve assembly with the two-way valve of the foregoing embodiments. Figure 12 shows a cross-sectional view of the two-way valve assembly of Embodiment 7 of the application. The two-way valve assembly provided by the application includes a first housing 10. The two-way valve 20 and the second housing 30, the first housing 10 and the second housing 30 are respectively connected to both sides of the two-way valve 20, the first housing 10 has a first inner cavity 101, the first inner cavity 101 Used to communicate with the first slit and the second slit of the two-way valve 20, the caliber of the first inner cavity 101 gradually decreases along the first pressure direction A-A to form a first interface 102, so that the first housing 10 An inner cavity 101 forms a structure similar to a funnel. When the two-way valve 20 deforms under the first pressure, the first inner cavity 101 of the first housing 10 can prevent it from undergoing severe deformation, and when the first pressure is eliminated Can help the two-way valve 20 quickly return to the original state; the second housing 30 has a second inner chamber 301, the second inner chamber 301 is used to communicate with the first slit and the second slit of the two-way valve 20, the second inner chamber The caliber of 301 gradually decreases along the second pressure direction B-B 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 arranged between the first inner cavity 101 and the second inner cavity 301 Between the inner cavity 301 , the second housing 30 , the two-way valve 20 and the first housing 10 are arranged in sequence along the first pressure direction A-A.

Further, 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), poly Propylene (PP), polyethylene (PE), polystyrene (PS), polymethyl methacrylate (PMMA), polyethylene terephthalate (PET), methyl methacrylate-butadiene - Styrene copolymer (MBS), molding methods include but not limited to injection molding or machining molding.

Finally, the application also protects the PICC (peripherally inserted central venous) catheter with the aforementioned two-way valve assembly, the valve plate is also provided with a slit for the guide wire to pass through, and the guide wire is used to guide the PICC tube to complete the tube delivery. The first embodiment adopts the first embodiment shown in FIG. 1, and the slit for passing through the guide wire coincides with the first slit 4 on the pressure response part 2; for another embodiment, refer to FIG. 7 In the fourth embodiment shown, the slit 7 for passing through the guide wire is set at the center of the first pressure response area 21, and the first slit 6 and the second slit 6' are respectively distributed on both sides of the slit 7. , usually, the narrow slit 7 is only used for inserting the guide wire, and does not undergo substantial deformation, and therefore does not respond to pressure, so it will not affect infusion and blood withdrawal. Therefore, those skilled in the art can combine different valve plate implementations to set a suitable guide wire insertion slit.

Fig. 13 shows an exploded view of the PICC conduit according to the eighth embodiment of the present application, wherein the two-way valve assembly 40 includes a first housing 10, a two-way valve 20 and a second housing 30, the second housing 30 has a Luer connector, It is mainly used to connect other medical components, perform infusion or withdraw blood. 50 is an extension tube, which is convenient for observing the situation of medicinal liquid and blood return in the process of use. Optionally, the extension tube 50 is transparent; 60 is a suture wing with through holes 61 on both sides, which are mainly used to cooperate with the catheter fixing device to fix the PICC on the body surface. 70 is the main pipe of PICC, which is made of medical polyurethane material through extrusion process. The main pipe can be mainly divided into the reduced diameter pipe part 71 near the suture wing end and the non-reduced pipe part. The use of the reduced diameter pipe is beneficial to improve the Flexural properties. In addition, the central venous catheter inserted through peripheral veins also includes a guide wire, which passes through the pressure-responsive two-way valve assembly 40, and guides the PICC catheter through the guide wire to complete the catheter delivery.

It should be noted that the technical effect of the two-way valve assembly and the peripherally inserted central venous catheter applicable to the two-way valve assembly is similar to the technical effect of the two-way valve provided in the present application, so details are not repeated here.

The above-mentioned schemes can be used together, not limited to independent schemes, 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. On a CVC (Central Venous Catheter) or other medical device that requires pressure response.

The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, should be considered as within the scope of this specification.

The above-mentioned embodiments only express several implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but should not be construed as limiting the patent scope of the invention. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.

Claims

A two-way valve, characterized in that it includes a fixed part and a pressure response part, the fixed part is arranged along the circumference of the pressure response part, the pressure response part includes a first pressure response area and a second pressure response area, the A first slit is provided on the first pressure response area, a second slit is provided on the second pressure response area, the first slit is configured to open at least under the action of the first pressure, and the second The slit is configured to open under at least 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 two-way valve according to claim 1, wherein the second pressure response zone is set along the circumference of the first pressure response zone, or, the second pressure response zone is set at the first pressure response zone both sides of the area;

The first slit is arranged in the middle of the pressure response part, and the second pressure response area is provided with 2n second slits symmetrical to the first slit, and the first pressure response The material hardness of the zone is less than the material hardness of the second pressure responsive zone.
The two-way valve according to claim 2, wherein the first pressure response area is convex along the first pressure direction.
The two-way valve according to claim 2, wherein the Shore hardness of the material of the first pressure response zone is less than 50A, and the Shore hardness of the material of the second pressure response zone is greater than 55A.
The two-way valve according to claim 1, wherein the first pressure response area comprises a valve plate, the middle part of the valve plate has a protrusion protruding outward along the first pressure direction, and the first slit Set on the protrusion, the second pressure response area includes a groove set on the valve plate, the groove is concave along the second pressure direction, the second slit is set on the The bottom wall of the groove.
The two-way valve according to claim 5, wherein the groove is disposed on the protrusion, the first slit at least partially overlaps with the second slit, and the first slit The slit communicates with the second slit between the bottom wall of the groove and the bottom surface of the valve plate.
The two-way valve according to claim 6, characterized in that, the second pressure response area further includes a recessed area concave along the second pressure direction, the groove is arranged in the recessed area, the The radius of curvature of the recessed area is smaller than the radius of curvature of the protrusion.
The two-way valve according to claim 5, wherein the grooves are arranged on both sides of the protrusion, and the length of the first slit is greater than the length of the second slit.
The two-way valve according to claim 8, wherein the grooves are arranged symmetrically on both sides of the protrusion, and the outer contours of the two grooves perpendicular to the second pressure direction are on the same circumference , the center of the circle is on the first slit.
The two-way valve according to claim 5, wherein the number of the grooves is plural, and a plurality of the grooves are circumferentially arranged around the protrusion of the first pressure response area.
The two-way valve according to claim 10, wherein the shape of the second slit includes one or more combinations of right-angle, I-shape and straight-shape.
The two-way valve according to claim 1, wherein the first pressure response area comprises a valve plate, one side of the valve plate has a protrusion protruding outward along the first pressure direction, and the first narrow A slit is set on the protrusion, the second pressure response area includes a groove set on the other side of the valve plate, the groove is concave along the second pressure direction, and the second slit set on the bottom wall of the groove.
The two-way valve according to claim 12, wherein the length of the first slit is greater than the length of the second slit.
The two-way valve according to claim 6 or 7, wherein the length of the first slit and the length of the second slit are at least 0.2mm longer than the length of the groove, and the first slit A slit and the second slit are not in contact with the fixing portion.
The two-way valve according to any one of claims 9-13, characterized in that, the length of the first slit is at least 0.2mm longer than the length of the protrusion, and the first slit and the The second slit is not in contact with the fixing portion.
The two-way valve according to any one of claims 1-13, wherein the first pressure is less than half of the second pressure.
The two-way valve according to any one of claims 5-13, characterized in that, the materials of the first pressure response zone and the second pressure response zone include butyl rubber, styrene-butadiene rubber, EPDM One or more of rubber, fluorosilicone rubber and liquid silicone rubber.
The two-way valve according to claim 17, characterized in that the Shore hardness of the material of the two-way valve is between 40A-75A.
The two-way valve according to any one of claims 1-13, characterized in that, the two-way valve is formed by integral injection molding.
A two-way valve assembly, comprising the two-way valve according to any one of claims 1-19, characterized in that it also includes a first housing and a second housing, the first housing has a first inner cavity, The first inner cavity is used to communicate with the first slit and the second slit of the two-way valve, and the diameter of the first inner cavity gradually decreases along the first pressure direction; the The second housing has a second inner chamber, which is used to communicate with the first slit and the second slit of the two-way valve, and the diameter of the second inner chamber is along the The second pressure direction decreases gradually; the second housing, the two-way valve and the first housing are sequentially arranged along the first pressure direction.
The two-way valve assembly according to claim 20, wherein the materials of the first housing and the second housing include polycarbonate, acrylonitrile-butadiene-styrene copolymer, polypropylene, One or more of polyethylene, polystyrene, polymethyl methacrylate, polyethylene terephthalate, methyl methacrylate-butadiene-styrene copolymer.
A PICC catheter, comprising the two-way valve assembly according to claim 20 or 21, characterized in that the PICC catheter also includes a guide wire, and the two-way valve assembly includes a guide wire hole for the guide wire to pass through .
The PICC catheter according to claim 22, characterized in that it also includes a main body pipe, the main body pipe is made of medical polyurethane material through extrusion process, and the main body pipe is divided into a variable diameter tube part and a non-variable diameter tube material part.
The PICC catheter according to claim 23, further comprising a suture wing, the suture wing is connected to the reducing tube part, and there are through holes on both sides of the suture wing, and the through holes are used to The main pipe is fixed on the body surface.