Hemostatic valve

Abstract

The present invention aims to provide a hemostatic valve that enables reliable hemostasis with a simple mechanism and easy operation in procedures using medical devices such as catheters. [Solution] A hemostatic valve for medical use, comprising a body that can be fitted into a cylindrical hub, wherein the body has at least one cylindrical portion penetrating along the longitudinal axis of the body, and a notch penetrating along the longitudinal axis of the body between at least one of the cylindrical portions and the outer edge of the body.

Description

Technical Field

[0001] The present invention relates to a hemostatic valve.

Background Art

[0002] Generally, in a procedure using a medical device such as a catheter, a guiding needle is punctured into a living tube such as a blood vessel, an insertion sheath is inserted into the puncture hole and left in the living tube, and a catheter is delivered into the living tube through the insertion sheath. At this time, in order to prevent bleeding from the blood vessel to the outside, a hemostatic valve body may be provided on a member at the proximal end side of the insertion sheath such as a catheter hub.

[0003] For example, in Patent Document 1, there is a valve body for hemostasis. When a blood vessel catheter is introduced into a blood vessel under the guidance of a guide wire, blood in the blood vessel flows into the passage of the blood vessel catheter, but a plug provided with a valve body is fitted to a hub provided at the proximal end portion of the blood vessel catheter, and since the first cut and the second cut of the valve body are in a closed state, it is described that blood does not flow out from the proximal end opening of the blood vessel catheter to the outside.

[0004] In Patent Document 2, there is a hemostatic valve for a blood vessel introducer. The hemostatic valve includes a first cut group and a second cut group defined in a seal region for a sealed passage of a medical device, and by radially arranging the first cut group in the central portion, it is described that medical devices of various sizes can easily pass through the cuts.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0006] The inventors of the present invention have noticed a problem with conventional valves into which a catheter is inserted: depending on how they are used, the gap can become large, causing blood to leak from the gap between the gap and the catheter. Therefore, the present invention aims to provide a hemostatic valve that enables reliable hemostasis with a simple mechanism and easy operation in procedures using medical devices such as catheters. [Means for solving the problem]

[0007] In other words, the present invention relates to the following: [1] A hemostatic valve for medical use, comprising a body that can be fitted into a cylindrical hub, the body having at least one cylindrical portion penetrating along the longitudinal axis of the body, and a notch penetrating along the longitudinal axis of the body between at least one of the cylindrical portions and the outer edge of the body. [2] The hemostatic valve according to [1], wherein at least one of the cylindrical portions further has a notch that penetrates between the cylindrical portion and the other cylindrical portion along the longitudinal axis of the body. [3] A hemostatic valve according to [1] or [2], having two or three cylindrical parts. [4] A hemostatic valve according to any one of [1] to [3], wherein the main body has a portion that gradually widens in diameter from the tip to the base.

[0008] [5] A hemostatic valve according to any one of [1] to [4], wherein the main body further has a gripping portion having an outer diameter larger than the inner diameter of the cylindrical hub. [6] A hemostatic valve according to any one of [1] to [5], wherein each cylindrical part has a different inner diameter. [7] A hemostatic valve according to any one of [1] to [6], wherein the cylindrical portion has an inner diameter selected from the group consisting of 0.9 mm, 0.48 mm, and 0.36 mm. [8] A hemostatic valve as described in any one of [1] to [7], wherein the length of the main body in the vertical axis direction is 1 to 10 mm. [Effects of the Invention]

[0009] According to the present invention, reliable hemostasis can be achieved with a simple mechanism and easy operation, offering significant advantages in terms of workability and manufacturing costs. [Brief explanation of the drawing]

[0010] [Figure 1] Figure 1 is a conceptual diagram showing a medical device according to the first embodiment of the present invention. [Figure 2] Figure 2 is a conceptual diagram showing a medical device according to a second embodiment of the present invention. [Figure 3] Figure 3 is a conceptual diagram showing a medical device according to a third embodiment of the present invention. [Modes for carrying out the invention]

[0011] In the present invention, "tubular hub" refers to a cylindrical housing used when introducing a long medical device into a biological tube. Examples of long medical devices include catheters and guidewires. The tubular hub may include, for example, a housing that is wider in diameter than the tube and connected to the proximal end of a small-diameter tube such as an outer sheath, insertion sheath, or dilator tube, a dilator hub, or a catheter hub.

[0012] When introducing medical devices, the tubular body is placed inside the biological tube, and then inserted through an enlarged cylindrical hub connected to the proximal end of the tubular body, facilitating guidance into the smaller tubular body. The cross-section of the cylindrical hub is basically circular, but it may also be triangular, square, polygonal, or elliptical. The cylindrical hub (excluding the smaller tubular body portion) may have the same internal diameter from tip to proximal end, or it may have an internal diameter that gradually widens from tip to proximal end. In the latter case, for example, it may have a Luer taper shape as defined in ISO 80389. By using the cylindrical hub like a funnel, the guidance of the medical device into the tubular body can be facilitated.

[0013] In this invention, "body" refers to a solid body that can be fitted into and sealed within a cylindrical hub. The body has at least one cylindrical portion that penetrates along the longitudinal axis of the body. The cylindrical portion has an inner diameter that is approximately the same as the outer diameter of the elongated medical device used. As a result, when the elongated medical device is inserted through the cylindrical portion, the cylindrical portion is closed, and the sealed state of the cylindrical hub by the body can be maintained.

[0014] In this invention, "notch" refers to a straight notch provided in the main body. The notch is provided to penetrate the vertical axis of the main body between at least one of the cylindrical parts and the outer edge of the main body. The notch exists in a closed state and can be expanded by pressing a medical device against it. After the medical device is housed in the cylindrical part, it can return to its original closed state. That is, the notch has a width of 0 mm and can maintain the sealed state of the cylindrical hub by the main body.

[0015] The materials that make up the main body are not particularly limited as long as they are resilient materials, but examples include various rubber materials such as natural rubber, isoprene rubber, butyl rubber, butadiene rubber, styrene-butadiene rubber, urethane rubber, nitrile rubber, acrylic rubber, fluororubber, and silicone rubber, as well as various thermoplastic elastomers such as urethane-based, polyester-based, polyamide-based, olefin-based, and styrene-based materials, or mixtures thereof, and resin materials.

[0016] The main body has an outer shape that can be fitted into a cylindrical hub, and is basically a roughly cylindrical shape to match the cylindrical hub described above, but may also be a roughly triangular prism, a roughly square prism, a roughly polygonal prism, or a roughly elliptical prism. In the present invention, a roughly cylindrical shape includes a cylindrical shape having the same outer diameter from tip to base, a shape having an outer diameter that gradually widens from tip to base (tapered portion) (for example, a cork stopper shape, a frustoconical shape), a disc shape, etc., and the Luer taper shape specified in ISO 80389 is preferred.

[0017] The main body can be provided with a plurality of cylindrical portions according to the number of long medical devices to be used. The inner diameter of the cylindrical portion can be freely selected according to the outer diameter of the long medical device to be used, such as the inner diameter for "0035 inches (0.9 mm)", the inner diameter for "0018 inches (0.48 mm)", the inner diameter for "0014 inches (0.36 mm)", etc., which are the outer diameters of guide wires. The main body can be provided with a plurality of independent cylindrical portions having different inner diameters according to a plurality of medical devices having different outer diameters.

[0018] The length (thickness) of the main body in the longitudinal axis direction is not particularly limited, but can be 1 to 10 mm, preferably 3 to 8 mm. In particular, from the perspective of using the main body as a plug to be inserted into a cylindrical hub, it can be 5 to 7 mm. The cylindrical portion of the present invention penetrates along the longitudinal axis of the main body, and since the extending direction of the cylindrical portion and the extending direction of the long medical device coincide, the extending direction of the medical device can be defined. This is advantageous compared to the conventional cuts that cannot define the extending direction of the medical device.

[0019] In the present invention, "medical device" refers to mechanical devices, etc. that are intended to be used for the diagnosis, treatment, or prevention of human or animal diseases, or to affect the structure or function of the human or animal body. In the case of catheter treatment, it includes guide wires, micro catheters, guide wire support catheters, contrast catheters, guiding catheters, and also includes medical long bodies such as the shaft portion having an expansion lumen such as a balloon catheter or a stent delivery catheter. The hemostatic valve of the present invention is also included in the medical device.

[0020] Hereinafter, the hemostatic valve according to a preferred embodiment of the present invention will be described in detail while referring to the drawings. FIG. 1 shows a conceptual diagram of the hemostatic valve according to the first embodiment of the present invention. FIG. 2 shows a conceptual diagram of the hemostatic valve according to the second embodiment of the present invention. FIG. 3 shows a conceptual diagram of the hemostatic valve according to the third embodiment of the present invention.

[0021] In the figures of this application, the size of each component is exaggerated for the sake of clarity, and the illustrated components do not represent their actual size. Furthermore, the end closer to the user using the long medical device is referred to as the proximal end, and the end closer to the biopsy tube into which the medical device is introduced is referred to as the distal end.

[0022] First Embodiment First, a first embodiment of the present invention will be described. Figure 1a shows the hemostatic valve attached to a cylindrical hub, Figure 1b shows the hemostatic valve viewed from above, and Figure 1c shows the hemostatic valve viewed from below.

[0023] As shown in Figure 1a, the hemostatic valve 1 according to the first embodiment of the present invention includes a main body 11. The main body 11 has a substantially cylindrical shape that can be fitted into a cylindrical hub H connected to the proximal end of a small-diameter tube S that is placed in a biological tubule. The outer diameter of the main body 11 gradually increases from the tip to the proximal end, and it can be appropriately fitted into the cylindrical hub H which has an inner diameter that gradually increases from the tip to the proximal end.

[0024] Furthermore, the main body 11 has a gripping portion 14 (a disc-shaped part) with an outer diameter larger than the inner diameter of the cylindrical hub H. The gripping portion 14 can serve as a grip when attaching the main body 11 to the cylindrical hub H, as a lid that covers the opening of the cylindrical hub H, and as a stopper that defines the distance the main body 11 penetrates into the cylindrical hub H. The main body 11 (including the gripping portion 14) is provided with two independent cylindrical portions 12 into which a long medical device M can be inserted.

[0025] As shown in Figures 1a to 1c, the cylindrical portion 12 penetrates the main body 11 from the top surface to the bottom surface, along the vertical axis of the main body 11. The inner diameter of each cylindrical portion 12 is approximately the same as the outer diameter of each medical device M, so that the cylindrical portion 12 is properly closed by the medical device M, holding the medical device M while maintaining its extension direction. A notch 13 is provided between the cylindrical portion 12 and the outer edge of the main body 11, penetrating along the vertical axis of the main body 11.

[0026] The notches 13 penetrate radially from each cylindrical portion 12 toward the side surface of the main body 11 (Figure 1a), and also penetrate along the vertical axis of the main body 11 from the top surface toward the bottom surface (Figures 1b and 1c). In other words, the notches 13 are cut between the cylindrical portion 12 and the outer edge (side surface, top surface, and bottom surface) of the main body 11.

[0027] The medical device M can be inserted into the cylindrical portion 12 through the notch 13. That is, although the notch 13 is normally closed, the medical device M can also be snapped into the cylindrical portion 12 by pressing it against the notch 13 along the outer edge of the main body 11 and expanding it. This makes it advantageous for handling and replacement, as the main body 11 can be attached from any position between the tip and base of the medical device M, rather than from the tip or base.

[0028] Second Embodiment Next, a second embodiment of the present invention will be described. Figure 2a shows the hemostatic valve attached to a cylindrical hub, and Figure 2b shows the hemostatic valve viewed from above.

[0029] As shown in Figure 2a, the body 11 of the hemostatic valve 1 according to the second embodiment of the present invention gradually widens in diameter from the tip to the base, and can be properly fitted inside the cylindrical hub H to create a seal. In this embodiment, the body 11 does not have a gripping portion 14 as shown in Figure 1a. The body 11 is provided with two cylindrical portions 12a and 12b.

[0030] As shown in Figure 2b, a notch 13a is provided between the cylindrical portion 12a and the side surface of the main body 11. Additionally, a notch 13b is provided between the cylindrical portion 12b and the cylindrical portion 12a, extending through the vertical axis of the main body 11. When inserting a medical device M into the cylindrical portion 12b, the medical device M is first inserted into the cylindrical portion 12a through the notch 13a, and then further inserted into the cylindrical portion 12b through the notch 13b.

[0031] Next, by inserting another medical device M into the cylindrical portion 12a through the notch 13a, two medical devices M can be inserted from the same side of the main body 11. This is advantageous because, for example, the notch can be positioned on the side where force is easily applied during the procedure or on the side that is easy to see, and the two medical devices M can be snapped in continuously through that notch.

[0032] Third Embodiment Next, a third embodiment of the present invention will be described. Figure 3a shows the hemostatic valve attached to a cylindrical hub, and Figure 3b shows the hemostatic valve viewed from above.

[0033] As shown in Figure 3a, the body 11 of the hemostatic valve 1 according to the third embodiment of the present invention gradually expands in diameter from the tip to the base, and can be properly fitted inside the cylindrical hub H to create a seal. In this embodiment, the body 11 is provided with three cylindrical portions 12, and as shown in Figure 3b, three notches 13 are provided radially from each cylindrical portion 12 toward the side surface of the body 11.

[0034] When inserting a medical device M into each cylindrical section 12, it is inserted through each notch 13. In this way, the hemostatic valve 1 of the present invention can be provided with multiple independent cylindrical sections 12 and multiple independent dedicated notches 13 to match the number of medical devices M, so that when replacing one medical device M, the impact on other medical devices M can be minimized.

[0035] Conventional valve bodies, in which a catheter is inserted into a notch, are designed for so-called over-the-wire catheters, where a guidewire is inserted into the catheter lumen and then passed through the valve body's notch. Since only one guidewire or catheter passes through the valve body's notch, the gap is small, resulting in little to no blood leakage. Similarly, 0.014-inch rapid exchange catheters for coronary arteries, for example, use thin, long medical-grade materials such as a 0.014-inch guidewire or balloon catheter, which pass through the valve body's notch, resulting in a small gap and little to no blood leakage, which was not considered a problem.

[0036] However, in recent years, 0.035-inch rapid exchange catheters used to treat lesions in the arms and lower limbs have required passing two or more thick medical elongated materials, such as a 0.035-inch guidewire and balloon catheter, through the valve body's notch. This creates a large gap, which can lead to blood leakage from the gap between the notch and the catheter under pressurized conditions. The valve body of the present invention can accommodate two or three or more elongated materials, making it suitable for a variety of applications.

[0037] Although the present invention has been described above in preferred first to third embodiments, the present invention is not limited thereto. The main body 11 is not limited to a substantially cylindrical shape and may have any shape as long as it can seal the cylindrical hub H. The number of cylindrical parts 12 is not limited to two or three, but can be freely selected to one, four or more, etc., according to the number of medical devices M used. In the present invention, each component can be replaced with any component capable of performing a similar function, or any component can be added. [Explanation of symbols]

[0038] 1. Hemostatic valve 11 Main unit 12 Cylindrical section 13 cuts 14 Gripping part M Medical Devices S-shaped body H-shaped cylindrical hub

Claims

1. A hemostatic valve for medical use, comprising a body that can be fitted into a cylindrical hub, wherein the body has at least one cylindrical portion penetrating along the longitudinal axis of the body, and a notch penetrating along the longitudinal axis of the body between at least one of the cylindrical portions and the outer edge of the body.

2. The hemostatic valve according to claim 1, wherein at least one of the cylindrical portions further has a notch that penetrates between the cylindrical portion and the other cylindrical portion along the longitudinal axis of the main body.

3. A hemostatic valve according to claim 1 or 2, having two or three cylindrical portions.

4. The hemostatic valve according to claim 1 or 2, wherein the main body has a portion that gradually widens in diameter from the tip to the base.

5. The hemostatic valve according to claim 1 or 2, wherein the main body further has a gripping portion having an outer diameter larger than the inner diameter of the cylindrical hub.

6. The hemostatic valve according to claim 1 or 2, wherein each cylindrical portion has a different inner diameter.

7. The hemostatic valve according to claim 1 or 2, wherein the cylindrical portion has an inner diameter selected from the group consisting of 0.9 mm, 0.48 mm, and 0.36 mm.

8. The hemostatic valve according to claim 1 or 2, wherein the length of the main body in the vertical axis direction is 1 to 10 mm.

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