Valves and tubes, and methods for manufacturing tubes

Abstract

To provide a valve and tube with a simple structure that can suppress the formation of blood clots. [Solution] A tube having a backflow suppression section that suppresses the backflow of blood, It is equipped with a valve that is in the open position when blood is flowing normally and in the closed position when blood is flowing backward. The backflow suppression portion includes at least a part of the valve in the closed position and has a backflow-allowing portion that slightly permits the backflow of blood. At least a portion of the valve is joined to the inner wall of the pipe, thereby fixing the valve inside the pipe. The tube includes a backflow-restricting portion which is a region enclosed by the valve and the inner wall that prevents the backflow of blood, and a backflow-allowing portion which is a hole formed by a part of the valve not being joined to the inner wall.

Description

Technical Field

[0001] The present invention relates to a valve, a pipe, and a method for manufacturing the pipe.

Background Art

[0002] As the background art in this technical field, there is Japanese Patent Application Laid-Open No. 2022-60307 (Patent Document 1). This publication describes that "an artificial valve includes a valve tip movable between an open position that allows a forward flow through the artificial valve and a closed position that prevents a reverse flow through the artificial valve, and the valve tip has an aperture or gap or separation of a portion of the valve tip that allows a flow or exchange of fluid between the front and rear portions of the valve tip when the valve tip is not in the closed position."

Prior Art Documents

Patent Documents

[0007] The valve includes a joint that connects to the entire circumference of the inner wall of the pipe, except for the region in which the hole is formed. The aforementioned joint includes a convex portion that is convex in the direction of reverse blood flow, The hole is located at the apex of the convex-shaped portion, forming a tube.

[0008] The valve includes a joint that connects to the entire circumference of the inner wall of the pipe, except for the region in which the hole is formed. The aforementioned joint includes a convex portion that is convex in the direction of reverse blood flow, The shape of at least a portion of the edge of the valve corresponds to the shape of the joint, A tube in which the edge portion corresponding to the hole has a notched shape.

[0009] A valve for forming a tube having a backflow suppression section that suppresses the backflow of blood, It can be fixed to the tube so that it is in the open position when blood is flowing normally and in the closed position when blood is flowing backward. The valve in the closed position can constitute at least a part of the backflow suppression section, The valve, which constitutes a part of the backflow suppression section, has a backflow-allowing section that slightly permits the backflow of blood.

[0010] A method for manufacturing a tube having a backflow suppression section that suppresses the backflow of blood, A valve that is in an open position when blood is flowing normally and in a closed position when blood is flowing backward, wherein the valve is joined and fixed to the inner wall of the pipe such that the valve in the closed position constitutes at least a part of the backflow suppression section. A method for manufacturing a tube, wherein the backflow suppression portion is a region enclosed by the valve and the inner wall that prevents the backflow of blood, and a hole that slightly allows the backflow of blood is formed by not joining a part of the valve to the inner wall.

[0011] The valve is bonded to the inner wall so as to have a convex shape that protrudes in the direction of blood backflow over the entire circumference of the inner wall, except in the region where the hole is formed A method for manufacturing a tube, wherein the hole is formed at the apex of the convex portion

Advantages of the Invention

[0012] According to the present invention, it is possible to provide a valve and a tube that can suppress the formation of thrombi while having a simple structure Problems, configurations, and effects other than those described above will be clarified by the description of the following embodiments

Brief Description of the Drawings

[0013] [Figure 1] It is a development view of the valve [Figure 2A] It is a top view of a tube including the valve in the open position [Figure 2B] It is a perspective view of a tube including the valve in the open position [Figure 2C] It is a diagram for explaining the blood flow in FIG. 2B [Figure 3A] It is a top view of a tube including the valve in the closed position [Figure 3B] It is a perspective view of a tube including the valve in the closed position [Figure 3C] It is a diagram for explaining the blood flow in FIG. 3B ]> [Figure 4] It is a development view of the valve (modified example)

Modes for Carrying Out the Invention

[0014] The valve and the tube will be described with reference to FIGS. 1 to 4 The tube 1 is a tube for ensuring blood flow for patients with abnormalities in the heart or blood vessels The tube 1 includes a main body 2 and a valve 3 The tube 1 has a backflow suppression portion A for suppressing blood backflow

[0015] Body 2 is a long, hollow structure through which the fluid blood passes, and in this disclosure, body 2 has a circular cross-section.

[0016] Valve 3 is fixed inside the hollow body 2 and is a component that constitutes at least a part of the backflow suppression section A, which suppresses the backflow of blood. Figure 1 is an exploded view of valve 3. As shown in Figure 1, valve 3 includes three component members 31. Each component 31 includes an upper edge portion 31A and a lower edge portion 31B.

[0017] The upper edge portion 31A of the component member 31 is the upper edge portion in Figure 1 and is the folded portion. The lower edge portion 31B of the component member 31 is the lower edge portion in Figure 1 and is a meniscus-shaped portion that is convex downwards. The component 31 includes a connecting portion 31C that connects to other adjacent component 31s.

[0018] The material of the main body 2 and valve 3 in this disclosure is ePTFE (expanded polytetrafluoroethylene). In other embodiments, the main body and valve may be made of bio-derived materials such as Dacron, polyurethane, silicone, polypropylene, or collagen.

[0019] Figures 2 (Figures 2A, 2B, and 2C, hereafter the same) and 3 (Figures 3A, 3B, and 3C, hereafter the same) show pipe 1 in a state where valve 3 is joined and fixed inside the hollow interior of main body 2. Figure 2A is a top view of pipe 1 including valve 3 in the open position. Figure 2B is a perspective view of pipe 1 including valve 3 in the open position. Figure 2C is a diagram illustrating the blood flow shown in Figure 2B. Figure 3A is a top view of pipe 1 including valve 3 in the closed position. Figure 3B is a perspective view of pipe 1 including valve 3 in the closed position. Figure 3C illustrates the blood flow shown in Figure 3B.

[0020] As shown in Figures 2 and 3, the lower edge 31B of the valve 3 is joined to the inner wall of the main body 2, thereby fixing the valve 3 inside the main body 2. Hereinafter, "inner wall of the main body" may be simply referred to as "inner wall" or "inner wall of the pipe." In this disclosure, the lower edge 31B of the valve 3 is joined to the inner wall of the main body 2 by suture. As shown in Figure 1, the portion of the valve 3 that is joined to the inner wall is designated as the joint 3C. In Figures 2 and 3, the joint 3C is not shown to improve visibility. Valve 3 is joined to the inner wall of the main body 2 such that its left end 31D and right end 31E, as shown in Figure 1, are joined together (forming an annular ring with the three component members 31).

[0021] In another embodiment, the main body 2 and the valve 3 may be integrally formed from the same material.

[0022] As shown in Figures 2 and 3, valve 3 is fixed in place so as to move in accordance with the flow of blood inside the main body 2. Valve 3 is in the open position when blood is flowing normally, as shown in Figure 2, and in the closed position when blood is flowing backward, as shown in Figure 3.

[0023] As shown in Figure 2, when blood is flowing normally, valve 3 is located near the inner wall of tube 1 and opens the center of the inner diameter of tube 1 (it is in the open position). In Figure 2C, the normal flow of blood is illustrated by arrow F1.

[0024] As shown in Figure 3, when blood flows backward, the upper edges 31A of valve 3 converge in the center of tube 1, blocking the inner diameter of tube 1 (becoming the closed position). The backflow suppression section A includes at least a portion of the valve 3 in the closed position. In other words, the backflow suppression section A is a pocket-shaped region enclosed by the valve 3 in the closed position and the inner wall, as shown in Figure 3. In Figure 3C, the flow of blood flowing backward is illustrated by arrow F2. The flow of blood flowing backward F2 is blocked by valve 3 (backflow suppression section A) which is connected to the inner wall, and is then converted into a normal flow F1 along valve 3. Thus, the region that blocks the flow of blood flowing backward and converts it into a normal flow is the backflow suppression section A.

[0025] Incidentally, blood may accumulate in the backflow suppression section A, which prevents the backflow of blood and converts it back into a normal flow, and this may lead to the formation of blood clots. Therefore, the backflow suppression section A of the tube 1 in this disclosure has a backflow-allowing section B that slightly allows backflow of blood in order to suppress blood stagnation and the formation of a thrombus. The presence of a backflow-tolerant section B prevents the backflowing blood from accumulating in one area, thereby suppressing the formation of blood clots.

[0026] The purpose of the backflow suppression section A is to suppress the backflow of blood, but a small amount of backflow is tolerable. For example, when introducing a tube 1 having the reflux suppression section A of this disclosure into a portion of the pulmonary artery, it is possible to tolerate blood reflux of up to approximately 20% of the total volume of normally flowing blood. In other words, the tube 1 having the backflow suppression section A of this disclosure employs a mechanism that does not completely prevent the backflow of blood, but rather allows some backflow, thereby suppressing the stagnation of blood flow around the valve and preventing the formation of thrombi.

[0027] In this disclosure, the backflow-allowing portion B is a hole B formed by a part of the valve 3 not being joined to the inner wall. As illustrated in Figure 3C, some of the blood in the reverse-flowing blood flow F2 flows out of hole B to the outside of the backflow suppression section A (flow F3).

[0028] Valve 3 is joined to the entire circumference of the inner wall of pipe 1, except for the region where hole B is formed. In this disclosure, the shape of the lower edge portion 31B of the valve 3 corresponds to the shape of the joint portion 3C. In Figure 1, the joint portion 3C is shown to be inside the lower edge portion 31B, but in reality, it is joined along the lower edge portion 31B. In other words, the valve 3 is fixed to the inner wall by the lower edges 31B of the three constituent members 31 that make up the valve 3 being sewn to the inner wall.

[0029] The hole B is a portion of the lower edge 31B of valve 3 that is not sutured (joined) to the inner wall. Note that, as mentioned above, the joint 3C is not shown in Figures 2 and 3 (only the edge of valve 3 is shown), so the hole B, which is a region that is not joined, is an element that cannot be shown in the figures, but it is shown as a virtual hole (space) B to facilitate understanding.

[0030] The joint portion 3C includes a convex-shaped portion that is convex in the direction of reverse blood flow. Valve 3 has a meniscus shape in which each joint 3C of the component member 31 is convex in the direction of reverse blood flow, as shown in Figure 1. In this disclosure, hole B is located at the apex (lower end) of the convex shape. In the pocket-shaped backflow suppression section A, which is surrounded by the valve 3 including the convex joint 3C and the inner wall of the main body 2, blood may accumulate near the joint 3C, particularly near the apex of the joint 3C. Therefore, a backflow-allowing section (hole) B is located at the apex of the joint 3C.

[0031] In another embodiment, the backflow-allowing portion B may be located below the position of the upper end portion 3CE (Figure 1), which is the uppermost part of the joint portion having a convex shape that is convex in the direction of backflow, on the side where the apex is located, and is either the valve 3 (which constitutes the backflow-inhibiting portion A) or the main body 2. In other words, a backflow-allowing portion B may be provided in a part of the valve 3 or body 2 that constitutes the backflow-suppressing portion A, other than the joint portion 3C. In this case, the backflow-allowing portion B may be, for example, a hole, or a region composed of a material that allows blood to flow back more freely than other parts. As described above, for example, when introducing a tube with a backflow suppression section into a part of the pulmonary artery, it is possible to allow backflow of up to about 20% of the total volume of normally flowing blood, while the backflow-allowing section B may be designed to allow backflow of about 5% of the total volume of normally flowing blood.

[0032] In another embodiment, the shape of the joint, which includes a convex portion that is convex in the direction of reverse blood flow, can be any shape as long as it includes a portion that extends in the vertical direction.

[0033] The shape of at least a portion of the edge of valve 3 corresponds to the shape of the joint. As described above, the shape of the lower edge 31B of valve 3 in this disclosure corresponds to the shape of the joint. Figure 4 is an unfolded view of valve 3' (modified version). As shown in Figures 1 to 3, valve 3', a modified example of valve 3, may have a notched edge (or notched portion 3D) at the position corresponding to hole B, as shown in Figure 4.

[0034] In other embodiments of the valve, the shape of the edge and the shape of the joint do not necessarily correspond. That is, the shape of the lower edge of the valve and the shape of the joint may be different. For example, in the region inside the lower edge of the valve, it may be joined to the inner wall with a shape different from the shape of the lower edge.

[0035] In this disclosure, the main body 2 of the pipe 1 includes parts other than the part that constitutes the backflow suppression section A. However, in other embodiments, the main body of the pipe may consist only of the part that constitutes the backflow suppression section A, provided that it has a ring shape that forms a hollow space.

[0036] In another embodiment, the main body may be a mesh-like tubular device (stent) that can expand from a compressed state, except for the portion constituting the backflow suppression section A.

[0037] An example of a method for manufacturing the pipe 1 in this disclosure is described below. The manufacturer attaches and fixes the valve 3 to the inner wall of the pipe 1 such that it is in the open position when blood is flowing normally and in the closed position when blood is flowing backward, and that the valve 3 in the closed position constitutes at least a part of the backflow suppression section A. The manufacturer can easily attach the valve 3 to the inner wall of the pipe 1 by turning the main body 2 of the pipe 1 inside out in advance so that the inner wall that will be used during use is exposed to the outside.

[0038] The backflow suppression section A is a region enclosed by the valve 3 and the inner wall that prevents the backflow of blood. When the manufacturer joins the valve 3 to the inner wall of the tube 1, they leave a portion of the valve 3 unjoined to the inner wall, thereby creating a small opening (backflow-allowing section) B that allows for a slight backflow of blood.

[0039] The manufacturer joins and fixes valve 3 to the inner wall such that, except for the area in which hole B is formed, the valve has a shape that includes a convex shape that extends around the entire circumference of the inner wall and is convex in the direction of reverse blood flow. The manufacturer then forms hole B at the apex of the convex shape.

[0040] Finally, the manufacturer can produce the pipe 1 by turning the main body 2 inside out so that the valve 3 and inner wall face inward, rather than being exposed to the outside.

[0041] In manufacturing a tube having a backflow suppression section that inhibits the backflow of blood, the valve itself, which constitutes a part of the backflow suppression section, may have a backflow tolerance section that allows a small amount of backflow of blood. In other words, in the manufacturing method of the tube 1 described above, the hole (backflow tolerance section) B was formed by not joining a part of the valve 3 to the inner wall, but in another embodiment, the valve itself (the component itself) may have a region made of a material that allows backflow of blood through a hole or other part, and this valve may be joined to the inner wall of the tube all around. Furthermore, in the manufacturing method of the tube 1 described above, the hole (backflow tolerance section) B was formed by not joining a part of the valve 3 to the inner wall, but a valve made of a material that prevents a part of the valve from being joined to the inner wall may be used, or a valve may be used that has some kind of mark to prevent a part of the valve from being joined to the inner wall.

[0042] Although the present invention has been described in detail above, the present invention is not limited to the embodiments described above, and various modifications and improvements are possible without departing from the spirit of the present invention. [Explanation of symbols]

[0043] 1: tube 2: Main unit 3: Valve 31: Component 31A: Upper edge 31B: Lower edge 31C: Connecting part 31D:Left side end 31E: Right end 3C: Joint 3D: Notch A: Backflow suppression part B: Backflow-allowing section

Claims

1. A tube having a backflow suppression section that suppresses the backflow of blood, It is equipped with a valve that is in the open position when blood is flowing normally and in the closed position when blood is flowing backward. The backflow suppression section includes at least a portion of the valve in the closed position and has a backflow-allowing section that slightly permits backflow of blood. tube.

2. At least a portion of the valve is joined to the inner wall of the pipe, thereby fixing the valve inside the pipe. The backflow suppression portion is a region enclosed by the valve and the inner wall that prevents the backflow of blood, and includes the backflow-allowing portion, which is a hole formed by a part of the valve not being joined to the inner wall. The pipe according to claim 1.

3. The valve includes a joint that connects to the entire circumference of the inner wall of the pipe, except for the region in which the hole is formed. The aforementioned joint includes a convex portion that is convex in the direction of reverse blood flow, The aforementioned hole is located at the apex of the convex portion. The pipe according to claim 2.

4. The valve includes a joint that connects to the entire circumference of the inner wall of the pipe, except for the region in which the hole is formed. The aforementioned joint includes a convex portion that is convex in the direction of reverse blood flow, The shape of at least a portion of the edge of the valve corresponds to the shape of the joint, The edge portion corresponding to the hole has a notched shape. The pipe according to claim 2.

5. A valve for forming a tube having a backflow suppression section that suppresses the backflow of blood, It can be fixed to the tube so that it is in the open position when blood is flowing normally and in the closed position when blood is flowing backward. The valve in the closed position can constitute at least a part of the backflow suppression section, The valve, which constitutes a part of the backflow suppression section, has a backflow-allowing section that slightly permits the backflow of blood. valve.

6. A method for manufacturing a tube having a backflow suppression section that suppresses the backflow of blood, A valve that is in an open position when blood is flowing normally and in a closed position when blood is flowing backward, wherein the valve is joined and fixed to the inner wall of the pipe such that the valve in the closed position constitutes at least a part of the backflow suppression section. The backflow suppression portion is a region enclosed by the valve and the inner wall that prevents the backflow of blood, and by not joining a part of the valve to the inner wall, a hole is formed that slightly allows for the backflow of blood. A method for manufacturing pipes.

7. The valve is joined to the inner wall such that, excluding the region in which the hole is formed, the valve extends around the entire circumference of the inner wall and includes a convex shape that is convex in the direction of reverse blood flow. The aforementioned hole is formed at the apex of the convex portion. The method for manufacturing a pipe according to claim 6.

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