Medical valves

Abstract

We provide medical valves with excellent airtightness, sliding properties, and durability. [Solution] A medical valve 100 is installed in the opening 42 of a medical device 41 and has an axial direction from the inlet side to the back side of the opening 42. The medical valve 100 has, in this order from the inlet side, a first valve member 11 having a first elastic membrane portion 12 with a slit 15 formed therein, a second valve member 21 having a second elastic membrane portion 22 with a through hole 25 formed therein, and a third valve member 31 having a third elastic membrane portion 32 with a slit 35 formed therein. The slit 15 of the first elastic membrane portion 12 and the slit 35 of the third elastic membrane portion 32 are arranged to overlap with the through hole 25 of the second elastic membrane portion 22. In a cross-section along the axial direction of the first elastic membrane portion 12, the slit 15 of the first elastic membrane portion 12 extends substantially parallel to the axial direction, and in a cross-section along the axial direction of the third elastic membrane portion 32, the slit 35 of the third elastic membrane portion 32 extends substantially parallel to the axial direction.

Description

Technical Field

[0001] The present invention relates to a medical valve and a medical device provided with the medical valve.

Background Art

[0002] In catheter treatment, when introducing a catheter into a body cavity such as a blood vessel and delivering it to the treatment site, an insertion aid such as a guiding sheath may be used. A guiding sheath usually consists of a sheath tube and a sheath hub provided on the proximal side of the sheath tube. The sheath hub is provided with an insertion portion for the catheter, and a medical valve (hemostatic valve) is provided in the insertion portion. By providing a medical valve in the insertion portion of the sheath hub, it is possible to insert and remove the catheter while ensuring liquid tightness, and prevent blood or the like from leaking or air from mixing into the inside of the guiding sheath when inserting and removing the catheter. As such a medical valve, for example, Patent Document 1 discloses a medical valve having a first valve portion provided with a first hole and a second valve portion provided with a second hole arranged at a different position so as not to overlap the first hole, and Patent Document 2 discloses a medical valve having a double structure in which a first valve body formed with a slit and a second valve body formed with a through hole are stacked.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0004] While various medical valves have been known, medical valves are desirable to possess airtightness, smooth sliding properties, and durability. For example, in guiding sheaths, the internal pressure may be increased or decreased, and in such cases, it is desirable that air does not enter the internal cavity through the medical valve. On the other hand, improving airtightness requires enhancing the valve's closing function, but airtightness often has a trade-off relationship with the smooth sliding properties when inserting catheters into the medical valve. Furthermore, increasing the valve's closing function increases frictional resistance between the medical valve and the catheter inserted into it, which may lead to a decrease in the valve's durability.

[0005] The present invention has been made in view of the above circumstances, and its purpose is to provide a medical valve with excellent airtightness, sliding properties, and durability, and a medical device equipped with the medical valve. [Means for solving the problem]

[0006] The medical valve and medical device of the present invention that have been able to solve the aforementioned problems are as follows. [1] A medical valve installed in the opening of a medical device, having an axial direction from the inlet side to the back side of the opening; the medical valve comprises, in this order from the inlet side, a first valve member having a first elastic membrane portion with a slit formed therein, a second valve member having a second elastic membrane portion with a through hole formed therein, and a third valve member having a third elastic membrane portion with a slit formed therein; viewed from the inlet side, the slit of the first elastic membrane portion and the slit of the third elastic membrane portion are arranged to overlap with the through hole of the second elastic membrane portion; in a cross-section of the first elastic membrane portion along the axial direction, the slit of the first elastic membrane portion extends substantially parallel to the axial direction; and in a cross-section of the third elastic membrane portion along the axial direction, the slit of the third elastic membrane portion extends substantially parallel to the axial direction. [2] The medical valve according to [1], wherein the inlet side surface of the second elastic membrane portion is in contact with the rear side surface of the first elastic membrane portion, and the rear side surface of the second elastic membrane portion is in contact with the inlet side surface of the third elastic membrane portion. [3] The medical valve according to [1] or [2], wherein the slit of the first elastic membrane and the slit of the third elastic membrane are through slits. [4] The medical valve according to [1] or [2], wherein the slit in the first elastic membrane is a non-penetrating slit and the slit in the third elastic membrane is a penetrating slit, or the slit in the first elastic membrane is a penetrating slit and the slit in the third elastic membrane is a non-penetrating slit. [5] A medical valve according to any one of [1] to [4], wherein, viewed from the inlet side, the slit of the first elastic membrane extends with respect to the slit of the third elastic membrane at an angle difference of 45° or more, and the slit of the first elastic membrane and the slit of the third elastic membrane intersect each other at a position that overlaps with the through hole of the second elastic membrane. [6] A medical valve according to any one of [1] to [5], wherein, when viewed from the inlet side, the slit of the first elastic membrane and the slit of the third elastic membrane are arranged to overlap with the through hole of the second elastic membrane and extend outward beyond the outer edge of the through hole. [7] The first valve member has a recess on the inlet side surface, and the first elastic membrane is formed at the bottom of the recess, according to any one of [1] to [6]. [8] The medical valve according to any one of [1] to [7], wherein the third valve member has a recess on its inner surface and the third elastic membrane is formed at the bottom of the recess. [9] The medical valve according to any one of [1] to [8], wherein the first valve member has a first projection that protrudes further inward than the first elastic membrane on a part of the periphery of the first elastic membrane, and the third valve member has a third projection that protrudes further inward than the third elastic membrane on a part of the periphery of the third elastic membrane, and the first projection abuts against the third valve member at a location other than the third projection, and the third projection abuts against the first valve member at a location other than the first projection.

[10] The medical valve according to [9], wherein the second valve member has a second projection that protrudes from a part of the periphery of the second elastic membrane portion toward the inlet side and / or toward the rear side of the second elastic membrane portion, and the second projection abuts the first valve member at a location other than the first projection and / or abuts the third valve member at a location other than the third projection.

[11] A medical device equipped with a medical valve as described in any of [1] to

[10] . [Effects of the Invention]

[0007] The medical valve of the present invention offers excellent airtightness, sliding properties, and durability. [Brief explanation of the drawing]

[0008] [Figure 1] This image shows a side view of a guiding catheter, a medical device equipped with a medical valve. [Figure 2] Figure 1 shows the internal structure of the proximal part of the guiding catheter handle, and an exploded perspective view of the medical valve located inside the proximal part of the handle. [Figure 3] Figure 2 shows an asymmetrical view of the assembled medical valve. [Figure 4] Figure 2 shows a perspective view of the first valve member of the medical valve. [Figure 5] This figure shows a plan view of the first valve member shown in Figure 4, viewed from the rear. [Figure 6] Figure 5 shows a cross-sectional view of the first valve member from VI to VI. [Figure 7] Figure 2 shows a plan view of the second valve member of the medical valve. [Figure 8] This shows a cross-sectional view of the second valve member shown in Figure 7, specifically the VIII-VIII section. [Figure 9] Figure 2 shows a perspective view of the third valve member of the medical valve. [Figure 10] Figure 9 shows a plan view of the third valve member as seen from the inlet side. [Figure 11] Figure 10 shows a cross-sectional view of the third valve member from point XI to XI. [Modes for carrying out the invention]

[0009] Hereinafter, the present invention will be specifically described based on the following embodiments. However, the present invention is not limited by the following embodiments, and it is of course possible to appropriately modify and implement it within the range that can conform to the gist of the foregoing and following descriptions, and all of them are included in the technical scope of the present invention. In each drawing, for the sake of convenience, hatching, member numbers, etc. may be omitted, but in such cases, reference shall be made to the specification and other drawings. Also, the dimensions of various members in the drawings may differ from the actual dimensions because priority is given to facilitating the understanding of the features of the present invention.

[0010] The medical valve is installed at the opening of the medical device. The medical device equipped with the medical valve can insert a medical instrument into the inside of the medical device through the medical valve and can ensure liquid tightness by separating the inside and outside of the medical device. For example, when a part of the medical device is inserted into a blood vessel and a medical instrument is inserted through the medical valve, it is possible to suppress the leakage of blood from the opening of the medical device. Examples of the medical device include an endoscope, a catheter, a guiding sheath, etc. Specifically, examples include the operation part on the proximal side of the endoscope, the handle and hub on the proximal side of the catheter or guiding sheath. Examples of the medical instrument include a catheter, a dilator, a treatment instrument, etc.

[0011] The medical valve according to the embodiment of the present invention will be described with reference to FIGS. 1 to 11. FIG. 1 shows an overall side view of a guiding catheter (guiding sheath) as an example of a medical device equipped with a medical valve. FIG. 2 shows an internal structure of the proximal part of the handle of the guiding catheter shown in FIG. 1, and a disassembled perspective view of the medical valve provided inside the proximal part of the handle. FIG. 3 shows an assembled perspective view of the medical valve shown in FIG. 2. FIGS. 4 to 11 show perspective views, plan views, and cross-sectional views of the first valve member, the second valve member, and the third valve member constituting the medical valve shown in FIG. 2. Hereinafter, the guiding catheter may be simply referred to as a "catheter", and the medical valve may be simply referred to as a "valve".

[0012] As shown in FIG. 1, the catheter 51 has a handle 53 and a shaft 52 provided on the distal side of the handle 53. The catheter 51 is used by inserting the shaft 52 into a body cavity such as a blood vessel or digestive tract of a patient. In the catheter 51, the proximal side refers to the direction toward the user's hand side with respect to the extending direction of the catheter 51, and the distal side refers to the opposite direction of the proximal side, that is, the direction of the treatment target side.

[0013] The shaft 52 has a lumen and may be either a single lumen structure having one lumen inside or a multi-lumen structure having a plurality of lumens. The shaft 52 may have a coaxial structure provided with a plurality of coaxial lumens. Preferably, a wire for operating the shaft 52 is disposed in the lumen of the shaft 52. The wire is provided, for example, to control the bending of the distal end portion of the shaft 52. In this case, the distal end portion of the wire is preferably fixed to the distal end portion of the shaft 52. A conducting wire, an optical fiber, an endoscope, etc. may be disposed in the lumen of the shaft 52, or a lumen for inserting a guide wire or another treatment tool may be provided, or a lumen for flowing a drug, a contrast agent, any fluid may be provided.

[0014] The handle 53 has an opening 42 at its proximal end, and a valve 100 is installed in the opening 42. FIG. 2 shows the internal structure of the proximal portion of the handle 53, and in FIG. 2, the handle 53 serves as the medical instrument 41. The opening 42 of the medical instrument 41 is composed of a housing 43 for installing the valve 100 inside. By disposing the valve 100 in the housing 43 and covering it with a lid member 44, the valve 100 can be installed inside the opening 42. The lid member 44 has a hole 45, and the valve 100 is installed in the opening 42 so as to close the opening 42, and a medical instrument can be inserted into the valve 100 through the hole 45 of the lid member 44. Thereby, the inside and outside of the handle 53 can be separated to ensure liquid tightness, and a medical instrument can be inserted into the handle 53 through the valve 100.

[0015] The handle 53 has an internal passage that communicates with the shaft 52. In Figure 1, the proximal part of this internal passage branches into two. One branch connects to an opening 42 where a valve 100 is installed, and the other branch connects to a side port 54. A side tube 55 is connected to the side port 54, and a three-way stopcock 56 is provided on the side tube 55. For example, by connecting an indeflerator to the three-way stopcock 56, the inside of the catheter 51 can be increased or decreased in pressure. The three-way stopcock 56 can also function as a liquid inflow port for drugs, contrast agents, etc.

[0016] The valve 100 has an axial direction extending from the inlet side to the back side of the opening 42. The axial direction of the valve 100 is determined based on the inlet side and the back side of the opening 42 in which the valve 100 is installed, and the inlet side and the back side of the valve 100 are determined corresponding to the inlet side and the back side of the opening 42.

[0017] Valve 100 has a first valve member 11, a second valve member 21, and a third valve member 31 in that order from the inlet side. Valve 100 is formed by arranging the first valve member 11, the second valve member 21, and the third valve member 31 in an axial direction. The first valve member 11, the second valve member 21, and the third valve member 31 each have an elastic membrane portion, and a slit or through hole is formed in the elastic membrane portion. Specifically, the first valve member 11 has a first elastic membrane portion 12, and a slit 15 is formed in the first elastic membrane portion 12; the second valve member 21 has a second elastic membrane portion 22, and a through hole 25 is formed in the second elastic membrane portion 22; and the third valve member 31 has a third elastic membrane portion 32, and a slit 35 is formed in the third elastic membrane portion 32. The first elastic membrane portion 12 is a sheet-like portion formed in the first valve member 11, the second elastic membrane portion 22 is a sheet-like portion formed in the second valve member 21, and the third elastic membrane portion 32 is a sheet-like portion formed in the third valve member 31.

[0018] The first elastic membrane portion 12, the second elastic membrane portion 22, and the third elastic membrane portion 32 can be made of rubber or elastomer resin, for example, silicone rubber, fluororubber (vinylidene fluoride (FKM), tetrafluoroethylene-propylene (FEPM), tetrafluoroethylene-purple orovinyl ether (FFKM), etc.), butadiene rubber, nitrile rubber, hydrogenated nitrile rubber, acrylic rubber, urethane rubber, chloroprene rubber, ethylene propylene rubber, chlorosulfonated polyethylene, epichlorohydrin rubber, isoprene rubber, styrene-butadiene rubber, butyl rubber, natural rubber, etc. The parts of the first valve member 11 other than the first elastic membrane portion 12, the parts of the second valve member 21 other than the second elastic membrane portion 22, and the parts of the third valve member 31 other than the third elastic membrane portion 32 can also be made of rubber or elastomer resin.

[0019] The first valve member 11 will be described in detail with reference to Figures 4 to 6, the second valve member 21 will be described in detail with reference to Figures 7 to 8, and the third valve member 31 will be described in detail with reference to Figures 9 to 11. In the first valve member 11, the slit 15 is formed linearly in a plan view of the first elastic membrane portion 12 and can be formed by making a cut in the first elastic membrane portion 12. In the third valve member 31, the slit 35 is formed linearly in a plan view of the third elastic membrane portion 32 and can be formed by making a cut in the third elastic membrane portion 32. On the other hand, in the second valve member 21, the through hole 25 is formed to have a predetermined area in a plan view of the second elastic membrane portion 22 and can be formed by making a hole in the second elastic membrane portion 22.

[0020] The slit 15 may be a through-slit that penetrates the first elastic membrane portion 12, or a non-through-slit that does not penetrate the first elastic membrane portion 12. If the slit 15 is a non-through-slit, when a medical instrument is inserted into the valve 100, the tip of the medical instrument is pressed against the slit 15 and force is applied, causing the first elastic membrane portion 12 to tear at the slit 15, thus creating a through-slit. In Figure 6, the slit 15 is formed as a through-slit extending from the entrance side surface 13 to the back side surface 14 of the first elastic membrane portion 12.

[0021] If the slit 15 is a non-penetrating slit, it is sufficient for the slit 15 to be formed on at least one of the inlet-side surface 13 and the rear-side surface 14 of the first elastic membrane portion 12, or it may be formed on both the inlet-side surface 13 and the rear-side surface 14 of the first elastic membrane portion 12. In the former case, it is preferable that the slit 15 be formed on at least the inlet-side surface 13 of the first elastic membrane portion 12. This makes it possible to accurately determine the position to press the medical instrument against the first elastic membrane portion 12 using the slit 15 as a guide when inserting a medical instrument into the valve 100. In the latter case, it is preferable that the slit 15 formed on the inlet-side surface 13 and the slit 15 formed on the rear-side surface 14 of the first elastic membrane portion 12 are formed in positions that overlap each other in a plan view of the first elastic membrane portion 12 and extend in the same direction.

[0022] The slit 35 may be a through-slit that penetrates the third elastic membrane portion 32, or a non-through-slit that does not penetrate the third elastic membrane portion 32. If the slit 35 is a non-through-slit, when a medical instrument is inserted into the valve 100, the tip of the medical instrument is pressed against the slit 35 and force is applied, causing the third elastic membrane portion 32 to tear at the slit 35, thus creating a through-slit. In Figure 11, the slit 35 is formed as a through-slit extending from the entrance side surface 33 to the back side surface 34 of the third elastic membrane portion 32.

[0023] If the slit 35 is a non-penetrating slit, it is sufficient for the slit 35 to be formed on at least one of the inlet-side surface 33 and the rear-side surface 34 of the third elastic membrane portion 32, or it may be formed on both the inlet-side surface 33 and the rear-side surface 34 of the third elastic membrane portion 32. In the former case, it is preferable that the slit 35 be formed on at least the rear-side surface 34 of the third elastic membrane portion 32. This allows the slit 35 formed on the rear-side surface 34 of the third elastic membrane portion 32 to expand when a medical instrument is pressed against the inlet-side surface 33 of the third elastic membrane portion 32 when inserting the medical instrument into the valve 100, making the third elastic membrane portion 32 more prone to tearing at the slit 35. In the latter case, it is preferable that the slit 35 formed on the inlet-side surface 33 and the slit 35 formed on the rear-side surface 34 of the third elastic membrane portion 32 are formed in positions that overlap each other in a plan view of the third elastic membrane portion 32 and extend in the same direction.

[0024] The slits 15 and 35 may be formed in a straight line or a curved shape in a plan view of the first elastic membrane portion 12 or the third elastic membrane portion 32, but are preferably formed in a straight line. This makes it easier to ensure the airtightness and liquidtightness of the valve 100 when a medical instrument is inserted into the valve 100. Preferably, the slits 15 and 35 are each composed of a single straight line in a plan view of the first elastic membrane portion 12 or the third elastic membrane portion 32.

[0025] Slit 15 is formed to extend substantially parallel to the thickness direction of the first elastic membrane portion 12, and slit 35 is formed to extend substantially parallel to the thickness direction of the third elastic membrane portion 32. That is, as shown in Figure 6, in a cross-section along the axial direction of the first elastic membrane portion 12, slit 15 is formed to extend substantially parallel to the axial direction, and as shown in Figure 11, in a cross-section along the axial direction of the third elastic membrane portion 32, slit 35 is formed to extend substantially parallel to the axial direction. The cross-section along the axial direction of the first elastic membrane portion 12 means a cross-section obtained by cutting the first elastic membrane portion 12 in the thickness direction, and more specifically, a cross-section obtained by cutting the first elastic membrane portion 12 in the thickness direction perpendicular to the extension direction of slit 15 in a plan view of the first elastic membrane portion 12. The cross-section along the axial direction of the third elastic membrane portion 32 means a cross-section obtained by cutting the third elastic membrane portion 32 in the thickness direction, and more specifically, a cross-section obtained by cutting the third elastic membrane portion 32 in the thickness direction perpendicular to the extension direction of slit 35 in a plan view of the third elastic membrane portion 32. As a specific example of slits 15 and 35 extending substantially parallel to each other in the axial direction, it is preferable that slits 15 and 35 extend at an angle of 15° or less in the axial direction, more preferably at an angle of 10° or less, and even more preferably at an angle of 5° or less.

[0026] In the second valve member 21, the planar shape of the through hole 25 (the shape of the through hole 25 in a plan view of the second elastic membrane portion 22) is not particularly limited. Examples of the shape of the through hole 25 include circular, elliptical, oblong, polygonal, and irregular shapes. In Figure 7, the through hole 25 is formed as a circle in a plan view of the second elastic membrane portion 22.

[0027] Viewed from the inlet side of valve 100, the slit 15 of the first elastic membrane portion 12 and the slit 35 of the third elastic membrane portion 32 are arranged to overlap with the through hole 25 of the second elastic membrane portion 22. By arranging the first valve member 11, the second valve member 21, and the third valve member 31 in this overlapping manner, when a medical instrument is inserted through the slit 15 of the first elastic membrane portion 12, it becomes possible to insert the medical instrument through the through hole 25 of the second elastic membrane portion 22 and into the slit 35 of the third elastic membrane portion 32. Viewed from the inlet side of valve 100, the slit 15 of the first elastic membrane portion 12 and the slit 35 of the third elastic membrane portion 32 may extend in the same direction or in different directions.

[0028] As described above, valve 100 is configured to have excellent airtightness, sliding properties, and durability. Specifically, when the inside of the medical device 41 equipped with valve 100 is pressurized or depressurized, it becomes difficult for air to enter the inside through valve 100, thereby improving the airtightness of valve 100. Furthermore, sliding properties are ensured when inserting a medical device into valve 100, and damage to valve 100 during insertion of a medical device is suppressed, resulting in excellent durability. In medical valves, airtightness and sliding properties are often in a trade-off relationship, but valve 100 can achieve both airtightness and sliding properties. In addition, increasing the closing function of the valve to improve airtightness may increase frictional resistance when inserting a medical device, potentially leading to a decrease in the durability of the valve, but valve 100 is excellent in both airtightness and durability.

[0029] The valve 100 has a first elastic membrane portion 12 with a slit 15 and a third elastic membrane portion 32 with a slit 35, thereby ensuring the liquid-tightness and airtightness of the valve 100. The direction of extension of the slit 15 in the axial cross-section of the first elastic membrane portion 12 and the direction of extension of the slit 35 in the axial cross-section of the third elastic membrane portion 32 affect the durability and airtightness of the first elastic membrane portion 12 and the third elastic membrane portion 32. For example, if the slit 15 of the first elastic membrane portion 12 and / or the slit 35 of the third elastic membrane portion 32 extend obliquely at a 45° angle in the axial direction, the valve 100 is more likely to be damaged when inserting a medical instrument into the valve 100. Specifically, in the axial cross-section of the first elastic membrane portion 12 or the third elastic membrane portion 32, the first elastic membrane portion 12 or the third elastic membrane portion 32 is more likely to be damaged at the end of the obliquely extending slit 15 or slit 35. However, if the slit 15 of the first elastic membrane portion 12 and the slit 35 of the third elastic membrane portion 32 are formed to extend substantially parallel to each other in the axial direction, damage to the valve 100 when inserting a medical instrument into the valve 100 becomes less likely.

[0030] On the other hand, if the slits 15 and 35 are formed to extend approximately parallel to the axial direction as described above, the airtightness of the valve 100 tends to decrease compared to the case where the slits 15 and 35 are formed to extend obliquely to the axial direction. However, since the valve 100 has a second elastic membrane portion 22 with a through hole 25 formed between the first elastic membrane portion 12 with the slit 15 and the third elastic membrane portion 32 with the slit 35, it is possible to suppress the ingress of air through the valve 100 when the inside of the medical device 41 equipped with the valve 100 is pressurized or depressurized. For example, if the second elastic membrane portion 22 with the through hole 25 is not positioned between the first elastic membrane portion 12 and the third elastic membrane portion 32, both the first elastic membrane portion 12 and the third elastic membrane portion 32 tend to deform significantly in the axial direction when the inside of the medical device 41 is pressurized or depressurized. As a result, air bubbles tend to enter the inside of the medical device 41 through the slit 15 of the first elastic membrane portion 12 and the slit 35 of the third elastic membrane portion 32. However, by positioning the second elastic membrane portion 22, in which the through-hole 25 is formed, between the first elastic membrane portion 12 and the third elastic membrane portion 32, it is possible to suppress large axial deformation of both the first elastic membrane portion 12 and the third elastic membrane portion 32. When the inside of the medical device 41 is depressurized, the presence of the second elastic membrane portion 22 suppresses large axial deformation of the first elastic membrane portion 12, and when the inside of the medical device 41 is pressurized, the presence of the second elastic membrane portion 22 suppresses large axial deformation of the third elastic membrane portion 32. Therefore, even when the inside of the medical device 41 is pressurized or depressurized during use, it is possible to suppress the entry of air bubbles into the inside of the medical device 41 from the valve 100, thereby improving the airtightness of the valve 100.

[0031] Furthermore, the valve 100 is formed such that the slit 15 of the first elastic membrane portion 12 and the slit 35 of the third elastic membrane portion 32 extend substantially parallel to each other in the axial direction, and a through hole 25 is formed in the second elastic membrane portion 22, thus providing excellent sliding properties.

[0032] The lengths of the slits 15 and 35 and the size of the through-hole 25 can be appropriately set according to the size of the medical device to be inserted into the valve 100. The length of the slit 15 in a plan view of the first elastic membrane portion 12 and the length of the slit 35 in a plan view of the third elastic membrane portion 32 are preferably 2 mm or more, more preferably 3 mm or more, preferably 15 mm or less, and more preferably 10 mm or less.

[0033] The maximum length of the through-hole 25 in a plan view of the second elastic membrane portion 22 is preferably 0.5 mm or more, more preferably 1 mm or more, preferably 4 mm or less, and more preferably 3 mm or less. The maximum length of the through-hole 25 means the diameter of the circle if the through-hole 25 is circular, and the length in the major axis direction of the through-hole 25 if the through-hole 25 is non-circular. If the through-hole 25 is elliptical, it means the major axis of the ellipse. The ratio of the length in the major axis direction to the length in the minor axis direction (maximum length perpendicular to the major axis direction) of the through-hole 25 is preferably 3 / 1 or less, more preferably 2 / 1 or less, and even more preferably 3 / 2 or less.

[0034] When viewed from the inlet side of the valve 100, the slit 15 of the first elastic membrane portion 12 and the slit 35 of the third elastic membrane portion 32 are preferably arranged to overlap with the through hole 25 of the second elastic membrane portion 22 and to extend outward beyond the outer edge of the through hole 25. By providing the slit 15, slit 35 and through hole 25 in this way, the ease of inserting medical devices into the valve 100 can be improved, and the liquid-tightness and airtightness of the valve 100 can be improved. For example, the length of the slit 15 in a plan view of the first elastic membrane portion 12 and the length of the slit 35 in a plan view of the third elastic membrane portion 32 are preferably 1.5 times or more, more preferably 2.0 times or more, preferably 8.0 times or less, more preferably 6.0 times or less, and even more preferably 4.0 times or less than the maximum length of the through hole 25 in a plan view of the second elastic membrane portion 22.

[0035] The thicknesses of the first elastic membrane portion 12, the second elastic membrane portion 22, and the third elastic membrane portion 32 are preferably 0.1 mm or more, more preferably 0.2 mm or more, even more preferably 0.3 mm or more, preferably 3.0 mm or less, more preferably 2.5 mm or less, and even more preferably 2.0 mm or less. The thickness of the first elastic membrane portion 12 refers to the thickness of the first elastic membrane portion 12 at the location where the slit 15 is formed. The thickness of the third elastic membrane portion 32 refers to the thickness of the third elastic membrane portion 32 at the location where the slit 35 is formed. The thickness of the second elastic membrane portion 22 refers to the thickness of the second elastic membrane portion 22 on the side wall of the through hole 25.

[0036] The thickness of the first elastic membrane portion 12 is preferably shorter than the length of the slit 15, preferably 0.5 times or less the length of the slit 15, more preferably 0.3 times or less, and even more preferably 0.2 times or less. The thickness of the third elastic membrane portion 32 is preferably shorter than the length of the slit 35, preferably 0.5 times or less the length of the slit 35, more preferably 0.3 times or less, and even more preferably 0.2 times or less. The thickness of the second elastic membrane portion 22 is preferably shorter than the maximum length of the through hole 25, preferably 0.5 times or less the maximum length of the through hole 25, more preferably 0.3 times or less, and even more preferably 0.2 times or less.

[0037] It is preferable that the thickness of the first elastic membrane portion 12 and the thickness of the third elastic membrane portion 32 are greater than the thickness of the second elastic membrane portion 22. This prevents the first elastic membrane portion 12 and the third elastic membrane portion 32 from becoming too flexible, thereby improving the liquid-tightness and airtightness of the slit 15 of the first elastic membrane portion 12 and the slit 35 of the third elastic membrane portion 32. From this viewpoint, the thicknesses of the first elastic membrane portion 12 and the third elastic membrane portion 32 may be 0.5 mm or more, 0.7 mm or more, or 0.9 mm or more, respectively.

[0038] When the slit 15 is formed as a non-penetrating slit, the thickness of the slit 15 (length in the thickness direction of the first elastic membrane portion 12) is preferably 0.5 times or more the thickness of the first elastic membrane portion 12, more preferably 0.7 times or more, and even more preferably 0.8 times or more. When the slit 15 is formed on both the entrance side surface 13 and the back side surface 14 of the first elastic membrane portion 12, the thickness of the slit 15 refers to the total thickness of the slits 15 formed on each surface. When the slit 15 is formed in this manner, the first elastic membrane portion 12 becomes more easily torn at the slit 15 when the tip of a medical instrument is pressed against the slit 15, making it easier to insert the medical instrument into the slit 15.

[0039] When the slit 35 is formed as a non-penetrating slit, the thickness of the slit 35 (length in the thickness direction of the third elastic membrane portion 32) is preferably 0.5 times or more the thickness of the third elastic membrane portion 32, more preferably 0.7 times or more, and even more preferably 0.8 times or more. When the slit 35 is formed on both the entrance side surface 33 and the back side surface 34 of the third elastic membrane portion 32, the thickness of the slit 35 refers to the total thickness of the slits 35 formed on each surface. When the slit 35 is formed in this manner, the third elastic membrane portion 32 becomes more likely to tear at the slit 35 when the tip of a medical instrument is pressed against the slit 35, making it easier to insert the medical instrument into the slit 35.

[0040] It is preferable that the slit 15 of the first elastic membrane portion 12 and the slit 35 of the third elastic membrane portion 32 are through slits, as this facilitates the insertion of medical devices into the valve 100. On the other hand, it is also preferable that the slit 15 of the first elastic membrane portion 12 is a non-through slit and the slit 35 of the third elastic membrane portion 32 is a through slit, or that the slit 15 of the first elastic membrane portion 12 is a through slit and the slit 35 of the third elastic membrane portion 32 is a non-through slit. In this case, it is possible to prevent foreign objects from accidentally entering the inside of the medical device 41 from the valve 100 before use of the valve 100, and to ensure ease of insertion when inserting a medical device from the valve 100. In this case, it is more preferable that the slit 15 of the first elastic membrane portion 12 is a through slit and the slit 35 of the third elastic membrane portion 32 is a non-through slit. Since the second elastic membrane portion 22 and the third elastic membrane portion 32 are located behind the first elastic membrane portion 12, when a medical instrument is pressed against the first elastic membrane portion 12 during insertion into the valve 100, the first elastic membrane portion 12 cannot be significantly deformed. In contrast, the third elastic membrane portion 32 can be significantly deformed when a medical instrument is pressed against the third elastic membrane portion 32 during insertion into the valve 100. Therefore, when the slit 35 of the third elastic membrane portion 32 is a non-penetrating slit, the tip of the medical instrument is pressed against the slit 35, making the third elastic membrane portion 32 more likely to tear at the slit 35, thus facilitating the insertion of the medical instrument into the slit 35.

[0041] When viewed from the inlet side of the valve 100, the slit 15 of the first elastic membrane portion 12 and the slit 35 of the third elastic membrane portion 32 may extend in the same direction or in different directions. In order to suppress the entry of air bubbles into the medical device 41 when a medical device is inserted into the valve 100, it is preferable that the slit 15 extends at an angle difference of 45° or more relative to the slit 35 when viewed from the inlet side of the valve 100, more preferably at an angle difference of 60° or more, and even more preferably at an angle difference of 75° or more. Furthermore, it is preferable that the slit 15 of the first elastic membrane portion 12 and the slit 35 of the third elastic membrane portion 32 intersect each other at a position that overlaps with the through hole 25 of the second elastic membrane portion 22. This causes the opening directions of the slits 15 and 35 to be misaligned when a medical device is inserted into the slits 15 and 35, and as a result, the entry of air bubbles into the medical device 41 can be further suppressed. Since the angle difference between the extending direction of slit 15 and the extending direction of slit 35, as viewed from the inlet side of valve 100, can be in the range of 0° to 90°, slit 15 only needs to extend with an angle difference of 90° or less relative to slit 35.

[0042] Preferably, the entrance-side surface 23 of the second elastic membrane portion 22 abuts against the rear-side surface 14 of the first elastic membrane portion 12, and the rear-side surface 24 of the second elastic membrane portion 22 abuts against the entrance-side surface 33 of the third elastic membrane portion 32. With the first elastic membrane portion 12, the second elastic membrane portion 22, and the third elastic membrane portion 32 provided in this manner, the first elastic membrane portion 12 and the third elastic membrane portion 32 are prevented from being greatly deformed in the axial direction, thereby preventing air bubbles from being mixed into the inside of the medical device 41. In addition, the first elastic membrane portion 12 and the third elastic membrane portion 32 are supported by the second elastic membrane portion 22, making it easier to ensure sliding properties in the slits 15 and 35.

[0043] Preferably, a recess 16 is formed on the inlet-side surface 13 of the first valve member 11, and a first elastic membrane portion 12 is formed at the bottom of the recess 16 (see Figure 6). With the first valve member 11 configured in this way, the thickness of the peripheral portion of the first valve member 11 can be increased, and the thickness of the first elastic membrane portion 12 can be made thinner than that of the peripheral portion. As a result, the first elastic membrane portion 12 is supported by the peripheral portion of the first valve member 11, and even if the thickness of the first elastic membrane portion 12 is made thin, the first elastic membrane portion 12 can be held stably, and the ease of insertion of the medical device into the slit 15 can be improved.

[0044] Preferably, a recess 36 is formed on the inner surface 34 of the third valve member 31, and a third elastic membrane portion 32 is formed at the bottom of the recess 36 (see Figure 11). With the third valve member 31 configured in this way, the thickness of the peripheral portion of the third valve member 31 can be increased, and the thickness of the third elastic membrane portion 32 can be made thinner than that of the peripheral portion. As a result, the third elastic membrane portion 32 is supported by the peripheral portion of the third valve member 31, and even if the thickness of the third elastic membrane portion 32 is made thin, the third elastic membrane portion 32 can be held stably, and the ease of insertion of the medical device into the slit 35 can be improved.

[0045] Preferably, the first valve member 11 has a first projection 17 that protrudes further inward than the first elastic membrane 12 from a part of the periphery of the first elastic membrane 12, and preferably the third valve member 31 has a third projection 37 that protrudes further inward than the third elastic membrane 32 from a part of the periphery of the third elastic membrane 32. Preferably, the first projection 17 abuts against the third valve member 31 at a location other than the third projection 37, and preferably the third projection 37 abuts against the first valve member 11 at a location other than the first projection 17. With the first valve member 11 and the third valve member 31 configured in this way, as shown in Figure 3, it becomes easy to sandwich the second valve member 21 between the first valve member 11 and the third valve member 31 and combine and integrate the first valve member 11 and the third valve member 31.

[0046] It is preferable that a first groove 18 is formed on the side surface of the first valve member 11 and a third groove 38 is formed on the side surface of the third valve member 31. Furthermore, it is preferable that the first projection 17 is engaged with the third groove 38 and the first projection 17 abuts against the third valve member 31 at the third groove 38, and that the third projection 37 is engaged with the first groove 18 and the third projection 37 abuts against the first valve member 11 at the first groove 18. By configuring the first valve member 11 and the third valve member 31 in this way, the first valve member 11 and the third valve member 31 can be assembled together more stably.

[0047] The second valve member 21 has a second projection 26 that protrudes from a part of the periphery of the second elastic membrane portion 22 toward the inlet side and / or the rear side of the second elastic membrane portion 22, and it is preferable that the second projection 26 abuts against the first valve member 11 at locations other than the first projection 17 and / or abuts against the third valve member 31 at locations other than the third projection 37. That is, if the second projection 26 protrudes toward the inlet side of the second elastic membrane portion 22, it is preferable that the second projection 26 abuts against the first valve member 11 at locations other than the first projection 17, and if the second projection 26 protrudes rear side of the second elastic membrane portion 22, it is preferable that the second projection 26 abuts against the third valve member 31 at locations other than the third projection 37. In Figures 2, 3, 7, and 8, the second projection 26 is configured to protrude toward the inlet side and the rear side of the second elastic membrane portion 22. With the second valve member 21 configured in this way, the second valve member 21 is stably held between the first valve member 11 and the third valve member 31, and when viewed from the inlet side of the valve 100, it becomes easy to align the through hole 25 of the second elastic membrane portion 22 with the slit 15 of the first elastic membrane portion 12 and the slit 35 of the third elastic membrane portion 32. [Examples]

[0048] The present invention will be described in more detail below with reference to examples, but the present invention is not limited by the following examples, and it is possible to implement it with appropriate modifications within the scope that is consistent with the spirit of the preceding and following descriptions, and all such modifications are included within the technical scope of the present invention.

[0049] (1) Manufacturing of the valve A guiding catheter handle as shown in Figure 1 was prepared, and valves A to F, configured as shown in Table 1, were fitted into the housing of the opening of the handle, and a cover member was attached to create a hemostatic valve. Valves A to C were configured with the first valve member, second valve member, and third valve member arranged in that order from the inlet side of the opening, and valves D to F were configured with the first valve member and second valve member arranged in that order from the inlet side of the opening. A slit or round hole was formed in each valve member. In Table 1, "parallel slit" means a slit formed so as to extend approximately parallel to the axial direction in a cross-section along the axial direction of each valve member, and "diagonal slit" means a slit formed so as to extend diagonally at an angle of approximately 45° along the axial direction in a cross-section along the axial direction of each valve member. Valves A through D and F are composed of two valve members having slits. In valves A and C, the two slits are positioned perpendicular to each other when viewed from the inlet side, while in valves B, D, and F, the two slits are positioned so that they extend in the same direction and overlap when viewed from the inlet side. In valve F, the oblique slits of the first valve member and the oblique slits of the second valve member combine to form a "<" shape in a cross-section along the axial direction of the third valve member of the first valve member.

[0050] (2) Evaluation method (2-1) Airtightness An inflator was connected to a three-way stopcock branching from the hemostatic valve, and physiological saline solution was supplied into the handle to gradually increase the pressure from 0.04 atm. The pressure increase was stopped when leakage from the hemostatic valve was confirmed. Next, the three-way stopcock was closed, and with physiological saline solution still inside the handle, the pressure was reduced to a maximum of -0.05 atm using the inflator, and the presence or absence of air bubbles from the hemostatic valve was observed. If no air bubbles were observed and the reduced pressure state was maintained, it was evaluated as "A". If air bubbles were observed but the reduced pressure state was maintained, it was evaluated as "B". If air bubbles were observed and the reduced pressure state could not be maintained, it was evaluated as "C".

[0051] (2-2) Sliding properties An 8Fr catheter was inserted through the hemostatic valve, and insertion and removal were repeated 50 times over a distance of 50 cm. Smooth insertion and removal without any abnormal noises was rated "A," while other cases were rated "B."

[0052] (2-3)Durability After the sliding performance evaluation test, the catheter was removed, an indeflerator was connected to the three-way stopcock branching from the hemostatic valve, and physiological saline solution was injected at 5 atm to observe leakage from the hemostatic valve. Subsequently, the hemostatic valve was disassembled, and the presence or absence of fracture or damage to each valve component was checked visually or under a stereomicroscope. If no leakage was observed and no fracture or damage to valve components was found, it was evaluated as "A"; if slight leakage or slight fracture or damage to valve components was observed, it was evaluated as "B"; and if obvious leakage or obvious fracture or damage to valve components was observed, it was evaluated as "C".

[0053] (3) Results Table 1 shows the evaluation results. Valve A corresponds to the medical valve of the present invention and received an A rating for airtightness, sliding properties, and durability, demonstrating excellent airtightness, sliding properties, and durability. On the other hand, valves B to F did not receive an A rating for airtightness, sliding properties, or durability in all categories, and their airtightness or durability was inferior to valve A.

[0054] [Table 1] [Explanation of symbols]

[0055] 100: Medical valves 11: First valve member 12: First elastic membrane section 13: Entrance side 14: The back side 15: Slit 16: Recess 17:First protrusion 18: First trench section 21: Second valve member 22: Second elastic membrane section 23: Entrance side 24: The back side 25: Through hole 26:Second protrusion 31: Third valve member 32: Third elastic membrane section 33: Entrance side 34: The back side 35: Slit 36: Recess 37: Third protrusion 38: Third groove 41: Medical devices 42: Opening 43: Housing 44: Lid component 45: Hole 51: Catheter 52: Shaft 53: Handle 54: Side port 55: Side tube 56: Three-way stopcock

Claims

1. A medical valve installed in the opening of a medical device, having an axial direction from the inlet side to the back side of the opening, The aforementioned medical valve comprises, in this order from the inlet side, a first valve member having a first elastic membrane portion with a slit, a second valve member having a second elastic membrane portion with a through hole, and a third valve member having a third elastic membrane portion with a slit. Viewed from the entrance side, the slit of the first elastic membrane and the slit of the third elastic membrane are arranged to overlap with the through-hole of the second elastic membrane. In a cross-section of the first elastic membrane portion along the axial direction, the slit of the first elastic membrane portion extends substantially parallel to the axial direction. A medical valve in which, in a cross-section of the third elastic membrane portion along the axial direction, the slit of the third elastic membrane portion extends substantially parallel to the axial direction.

2. The inlet side surface of the second elastic membrane portion is in contact with the rear side surface of the first elastic membrane portion. The medical valve according to claim 1, wherein the inner surface of the second elastic membrane portion is in contact with the inlet surface of the third elastic membrane portion.

3. The medical valve according to claim 1, wherein the slit in the first elastic membrane portion and the slit in the third elastic membrane portion are through slits.

4. The medical valve according to claim 1, wherein the slit in the first elastic membrane portion is a non-penetrating slit and the slit in the third elastic membrane portion is a penetrating slit, or the slit in the first elastic membrane portion is a penetrating slit and the slit in the third elastic membrane portion is a non-penetrating slit.

5. The medical valve according to claim 1, wherein, viewed from the inlet side, the slit of the first elastic membrane extends with an angular difference of 45° or more relative to the slit of the third elastic membrane, and the slit of the first elastic membrane and the slit of the third elastic membrane intersect each other at a position that overlaps with the through hole of the second elastic membrane.

6. The medical valve according to claim 1, wherein, when viewed from the inlet side, the slit of the first elastic membrane portion and the slit of the third elastic membrane portion are arranged to overlap with the through hole of the second elastic membrane portion and extend outward beyond the outer edge of the through hole.

7. The medical valve according to claim 1, wherein the first valve member has a recess on its inlet side surface, and the first elastic membrane is formed at the bottom of the recess.

8. The medical valve according to claim 7, wherein the third valve member has a recess on its inner surface, and the third elastic membrane is formed at the bottom of the recess.

9. The first valve member has a first projection that protrudes further inward than the first elastic membrane portion, on a part of the periphery of the first elastic membrane portion. The third valve member has a third projection that protrudes from the third elastic membrane portion toward the inlet side, on a part of the periphery of the third elastic membrane portion. The first projection contacts the third valve member at a location other than the third projection. The medical valve according to claim 1, wherein the third projection abuts the first valve member at a location other than the first projection.

10. The second valve member has a second projection that protrudes from a part of the periphery of the second elastic membrane portion toward the inlet side and / or the inner side of the second elastic membrane portion, The medical valve according to claim 9, wherein the second projection abuts the first valve member at a location other than the first projection, and / or abuts the third valve member at a location other than the third projection.

11. A medical device comprising a medical valve according to any one of claims 1 to 10.

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