Valve and medical device provided with same

Abstract

[Problem] To provide a valve capable of reliably achieving a balance between an improvement in sealing performance (prevention of air intake) and an improvement in operability (slidability) by using a structure that allows a lubricant not to drip, and a medical device provided with the valve. [Solution] Provided is a hemostasis valve (1) which is fitted in a valve holding portion (24) inside a sheath hub (21b) (valve housing) of a sheath (21) and into which a tubular introduction member such as a dilator and a catheter is inserted. A hemostasis valve (1) is provided with: a first partition wall (2) positioned on the proximal side; a second partition wall (3) positioned on the distal side, the second partition wall being provided adjacent to the first partition wall (2); the lubricant reservoir is provided between the first partition wall 2 and the second partition wall 3 and can store a lubricant. The lubricant reservoir (5) is formed by a flat cylindrical recess formed in the central axis direction on the inner surface of the first partition wall (2).

Description

Technical Field

[0001] The present disclosure relates to a valve and a medical device provided with the valve. More specifically, the present disclosure relates to a valve through which a tubular introduction member (such as a dilator, a catheter, or an endoscope tube) is inserted, and the present disclosure relates to a medical device provided with the valve. Background Art

[0002] Conventionally, a valve of this type disclosed in, for example, Patent Document 1 or the like is known.

[0003] The valve (hemostatic valve) disclosed in Patent Document 1 includes a proximal valve gasket (a first partition wall on the proximal side) and a distal valve gasket (a second partition wall on the distal side), wherein the outlet surface of the proximal valve gasket contacts the inlet surface of the distal valve gasket. The proximal valve gasket and the distal valve gasket are firmly held in the valve housing (see paragraphs

[0040] and

[0041] of Patent Document 1). Figure 1-Figure 4 The hemostatic valve includes (a proximal valve gasket and a distal valve gasket) made of a flexible and highly elastic polymer material so that a cylindrical medical device (a tubular introduction member) such as an elongated dilator or catheter with a non-constant diameter can be easily and repeatedly passed through (inserted into) the hemostatic valve (see paragraph

[0040] and FIG. 10 of Patent Document 1, etc.).

[0004] As a medical device, for example, when a cardiac catheter is inserted from a blood vessel (vena cava) into the left atrium, a hemostatic cannula assembly (introducer sheath) provided with such a hemostatic valve is used.

[0005] Literature in the prior art

[0006] Patent Literature

[0007] Patent Document 1: JP 4940526 B Summary of the invention

[0008] Technical problems to be solved by the present disclosure

[0009] The hemostatic valve must remain sealed even when no cylindrical medical device (tubular introducing member) is inserted through the valve.

[0010] However, if this is attempted, the resistance to the insertion of the cylindrical medical device through the hemostatic valve will inevitably increase, resulting in poor operability (slidability) in the insertion and removal of the cylindrical medical device. If the resistance to the insertion of the cylindrical medical device through the hemostatic valve increases, the hemostatic valve may fall off during the insertion and removal of the cylindrical medical device.

[0011] Furthermore, spontaneously breathing patients may have negative pressure in the left atrium, especially during insertion and removal of cylindrical medical devices (tubular introduction members), which may increase the risk of air entering from the hemostatic valve (risk of air aspiration) if the pressure in the left atrium is negative.

[0012] However, when the sealing performance of the hemostatic valve is improved in order to prevent this risk, the resistance to insertion of the cylindrical medical device through the hemostatic valve increases, and the operability (slidability) of inserting and removing the cylindrical medical device deteriorates.

[0013] Therefore, conventionally, a lubricant such as lubricating oil is applied to the surface of the hemostatic valve in order to achieve a balance between improvement in sealing performance (prevention of air intake) and improvement in operability (slidability).

[0014] However, if the lubricant is applied only to the surface of the valve, the lubricant will drip due to gravity during the period from the manufacture of the valve to its use, or when a medical device provided with the valve, such as a hemostatic sleeve assembly (introducer sheath), is used. Therefore, the operability (sliding property) is reduced, and it is difficult to achieve a balance between the improvement of the sealing performance (prevention of air inhalation) and the improvement of the operability (sliding property), and from this point of view, there is still room for improvement.

[0015] Therefore, an object of the present disclosure is to provide a valve and a medical device provided with the valve, which has a structure that does not allow lubricant to drip and which reliably achieves a balance between improvement in sealing performance (prevention of air inhalation) and improvement in operability (sliding property).

[0016] Solutions to technical problems

[0017] In order to achieve the above-mentioned object, the configuration of the valve according to the present disclosure is:

[0018] (1) A valve through which a tubular introduction member is inserted, the valve comprising:

[0019] a first septum located on the proximal side;

[0020] a distally located second partition wall disposed adjacent to the first partition wall; and

[0021] The lubricant reservoir is arranged between the first partition wall and the second partition wall, and the lubricant reservoir has the ability to store lubricant.

[0022] In the present disclosure, “adjacent” refers not only to a case where the first partition wall and the second partition wall are in direct contact with each other side by side, but also to a case where the lubricant is sealed near between the first partition wall and the second partition wall by a sealing member such as an O-ring.

[0023] In the present disclosure, the first partition wall and the second partition wall are preferably made of a flexible and highly elastic polymer material such as natural rubber, isoprene rubber, silicone rubber, or butadiene rubber.

[0024] For example, a liquid lubricant may be used as a "lubricant" in the present disclosure. Examples of liquid lubricants include lubricating oils, more specifically, silicone oils. Semisolid lubricants such as greases or compounds may also be used as "lubricants". Solid lubricants such as molybdenum disulfide and graphite added to a liquid lubricant such as silicone oil may also be used as "lubricants".

[0025] The above-mentioned configuration (1) of the valve of the present disclosure has the following effects.

[0026] Since a lubricant reservoir capable of storing lubricant is provided between the first partition wall and the second partition wall, the lubricant does not drip due to gravity during the period from the manufacture of the valve to its use or when a medical device provided with the valve, such as a hemostatic sleeve assembly (introducer sheath), is used. Since the lubricant does not drip in this way, the amount of the lubricant can be increased.

[0027] Therefore, the above configuration (1) of the valve of the present disclosure has a structure that does not allow the lubricant to drip and reliably achieves a balance between improvement in sealing performance (prevention of air intake) and improvement in operability (sliding property).

[0028] The above-mentioned configuration (1) of the valve according to the present disclosure preferably has the following configurations (2) to (7).

[0029] (2) In the above configuration (1), a groove for the adhesive is formed on the outer peripheral surface of the first partition wall and / or the second partition wall.

[0030] After applying the adhesive to the outer peripheral surface, the first and second partition walls are embedded in the valve container in the valve housing of the medical device. Since the outer diameters of the first and second partition walls are larger than the inner diameter of the valve container, most of the adhesive may be scraped off during the embedding. This may reduce the adhesion between the first and / or second partition walls and the valve container.

[0031] However, according to the above-mentioned preferred configuration (2), when applying the adhesive, the adhesive is filled into the adhesive groove formed on the outer peripheral surface of the first partition wall and / or the second partition wall and the adhesive is never scraped off during the embedding process. Therefore, the reduction in the adhesion between the first partition wall and / or the second partition wall and the valve container can be minimized.

[0032] (3) In the above configuration (1), the lubricant reservoir is formed at least on the outer (outer) surface of the first partition wall and / or the second partition wall along the central axis. According to the above preferred configuration (3), even when the lubricant is applied at least on the outer (outer) surface of the first partition wall and / or the second partition wall along the central axis, the lubricant is retained in the lubricant reservoir. Therefore, during the manufacture and use of the valve or when using a medical device (such as a hemostatic sleeve assembly (introducer sheath)), the lubricant is less likely to drip due to gravity. Therefore, the lubricant applied at least on the outer side of the first partition wall and / or the second partition wall along the central axis also helps to further improve the operability (slidability) and sealing performance (preventing air inhalation) when inserting and removing a tubular introduction member (such as a dilator, a catheter or an endoscope tube).

[0033] (4) In the above configuration (1), the position fixing hole is formed on the outer edge of the outside of the first and / or second walls along the central axis. According to the above preferred configuration (4), the first and / or second walls can avoid displacement (movement) around the central axis. Therefore, the appropriate relative position of the first and second walls around the central axis can be ensured, which can further improve the operability (slidability) and maintain the sealing performance when inserting and removing a tubular introduction member such as a dilator, a catheter or an endoscope tube.

[0034] (5) In the above configuration (1), a barrel-shaped recess having a flat bottom is formed on the outer surface of the second partition wall along the central axial direction. According to the above preferred configuration (5), the valve portion of the second partition wall can be easily opened.

[0035] (6) In the above configuration (1), a first conical recess and a second conical recess are formed on the outside of the first partition wall and the second partition wall respectively along the central axis, and the distance between the inner end of the first conical recess and the inner end of the second conical recess is set to 1.2 mm to 10.0 mm. According to the above preferred configuration (6), the sealing performance can be improved by the distance to further ensure that air is not sucked in.

[0036] (7) In the above configuration (1), the lubricant reservoir includes at least a third conical recess formed on the inner (inner side) surface of the second partition wall along the central axis. According to the above preferred configuration (7), when inserting a catheter, it is possible to prevent, for example, a braided or annular catheter from not advancing straight and mistakenly entering the lubricant reservoir.

[0037] The medical device of the present disclosure comprises:

[0038] (8) Any one of the above configurations (1) to (7) of the valve.

[0039] The above configuration (8) of the medical device of the present disclosure is provided with the valve of the present disclosure, so that the action and effect produced by the above valve can be exerted.

[0040] Technical Effects

[0041] The present disclosure has a structure that does not allow the lubricant to drip and that reliably achieves a balance between improved sealing performance (prevention of air inhalation) and improved operability (sliding property). BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 is a perspective view showing the external configuration of a medical device in one embodiment of the present disclosure.

[0043] Figure 2 is a perspective view showing an external configuration of an introducer sheath which is a component of a medical device in one embodiment of the present disclosure.

[0044] Figure 3A , Figure 3B and Figure 3C : is a diagram showing the external configuration of a sheath hub (valve housing) which is a component of the introducer sheath. Figure 3A is the remote view, Figure 3B is a side view, Figure 3C is a near-end view).

[0045] Figure 4 : is a longitudinal sectional view showing the internal configuration of a sheath hub (valve housing) which is a component of the introducer sheath.

[0046] Figure 5 is a longitudinal sectional view showing the configuration of a hemostatic valve in one embodiment of the present disclosure.

[0047] Figure 6 1 is a diagram showing a first partition wall in the proximal side as a component of a hemostatic valve in one embodiment of the present disclosure, as viewed from several directions.

[0048] Fig. 7A and Figure 7B : is an enlarged perspective view of the first partition wall on the proximal side of a component of a hemostatic valve as one embodiment of the present invention. Fig. 7A is the view from the far side, Figure 7B is a view from the near side).

[0049] Figure 8 1 is a diagram showing another configuration of the first partition wall in the proximal side as a component of the hemostatic valve in one embodiment of the present disclosure, as viewed from several directions.

[0050] Fig.9A and Fig. 9B is an enlarged view of another configuration of the first partition wall in the proximal side as a component of the hemostatic valve in one embodiment of the present disclosure ( Fig.9A is the remote view, Fig. 9Bis a near-end view).

[0051] Fig. 10A , Fig. 10B and Fig. 10C is a longitudinal cross-sectional view of another configuration of a hemostatic valve in one embodiment of the present disclosure (wherein Fig. 10A , Fig. 10B and Fig. 10C The size of the barrel-shaped recess in the distal second partition wall is different).

[0052] Fig.11 is a longitudinal sectional view showing another configuration of the hemostatic valve in one embodiment of the present disclosure.

[0053] Fig.12 is a longitudinal sectional view showing another configuration of the hemostatic valve in one embodiment of the present disclosure. DETAILED DESCRIPTION

[0054] The present invention will be described in more detail below using suitable examples. However, the examples are merely examples that embody the present disclosure, but do not limit the present disclosure.

[0055] Medical device configuration

[0056] First, when the tubular member is an introducer sheath, reference Figures 1 to 4 The configuration of a medical device provided with a hemostatic valve in one embodiment of the present disclosure is described.

[0057] exist Figure 1 The medical device 20 shown in FIG. 1 is a tip movable sheath provided with an introducer sheath (hereinafter referred to as a "sheath") 21 and a handle 22. The sheath 21 is formed of a flexible tube member. The handle 22 controls the orientation of the tip of the sheath 21. Figures 1 to 4 As shown, the sheath 21 is provided with a sheath tube 21a, a sheath hub (valve housing) 21b, a side port 21e, and a hemostatic valve 1 built into the sheath hub 21b. The sheath hub 21b is provided at the base end of the sheath tube 21a. The side port 21e is formed integrally with the sheath hub 21b and connected to the inside of the sheath tube 21a. The sheath 21 is used integrally with a dilator (not shown) when inserting a cardiac catheter from a blood vessel (vena cava) into the left atrium, for example. An insertion port 21f for inserting a dilator, a catheter, etc. is provided at the rear end of the sheath hub 21b.

[0058] A three-way stopcock (not shown) is attached to the side port 21e through a side tube (not shown). In order to prevent air from entering the blood vessel, a heparin saline solution (normal saline) is injected into the sheath tube 21a through the three-way stopcock before the sheath tube 21a is inserted into the blood vessel (to replace the air with normal saline). The three-way stopcock is also used to suck out the air that has entered the blood vessel when the dilator is withdrawn or another combined device is inserted into or removed from the sheath tube 21a after the sheath tube 21a is inserted into the blood vessel. In addition, a medical solution is also injected through the three-way stopcock.

[0059] The material of the sheath tube 21a is preferably a biocompatible synthetic resin selected from polyether block amide, polyamide (nylon 11), polytetrafluoroethylene, etc. The material of the sheath hub 21b is preferably a hard material (such as a hard resin). Examples of hard resins include polyethylene, polypropylene, polyamide, polycarbonate, and polystyrene.

[0060] The handle 22 is provided with a rotary operation part (turntable) 23 at the tip, so that the direction of the tip of the sheath tube 21a can be controlled by rotating the rotary operation part (turntable) 23. The specific configuration and operation method of the handle 22 are disclosed in detail in JP 6847542B and JP 6967644B, which are used as reference to omit repeated explanation.

[0061] Hemostatic valve configuration

[0062] Reference below Figures 5 to 7A and Figure 7B A specific configuration of a hemostatic valve in one embodiment of the present disclosure is described.

[0063] Figure 4 and Figure 5 The hemostatic valve 1 shown is a valve in a valve container 24 embedded in a sheath hub (valve housing) 21b of a sheath 21. A tubular introduction member such as a dilator or a catheter is inserted through the hemostatic valve 1. The hemostatic valve 1 has a double structure, which is expected to be more effective in hemostasis than a single valve.

[0064] like Figure 4 and Figure 5 As shown, the hemostatic valve 1 has a first partition wall 2 on the proximal side, and a second partition wall 3 on the distal side. The second partition wall 3 is arranged adjacent to the first partition wall 2. The hemostatic valve 1 has a lubricant storage 5, which is arranged between the first partition wall 2 and the second partition wall 3, and the lubricant storage 5 can store lubricant.

[0065] The lubricant reservoir 5 is composed of a flat cylindrical recess formed on the inner (inner) surface of the first partition wall 2 along the central axial direction (see Figure 6 , Fig. 7A and Figure 7B ).

[0066] In the hemostatic valve 1 of the present embodiment, "adjacent" means "side by side and in direct contact with each other."

[0067] The material of the first partition wall 2 and the second partition wall 3 is preferably made of a flexible and highly elastic polymer material such as natural rubber, isoprene rubber, silicone rubber, or butadiene rubber.

[0068] As the lubricant, for example, a liquid lubricant can be used. Examples of the liquid lubricant include lubricating oil, more specifically, silicone oil. As the lubricant, a semisolid lubricant such as grease or a compound can also be used as a lubricant. As the lubricant, for example, a solid lubricant such as molybdenum disulfide and graphite added to a liquid lubricant such as silicone oil can be used.

[0069] The configuration of the hemostatic valve 1 of the present disclosure has the following effects.

[0070] However, since the lubricant reservoir 5 capable of storing the lubricant is provided between the first partition wall 2 and the second partition wall 3, the lubricant does not drip due to gravity when the medical device 20 provided with the hemostatic valve 1 is used or during the period from manufacturing to using the valve. Since the lubricant does not drip in this way, the amount of the lubricant can be increased.

[0071] Therefore, the configuration of the hemostatic valve 1 of the present embodiment has a structure that does not cause the lubricant to drip and can reliably achieve a balance between the improvement of the sealing performance (prevention of air intake) and the improvement of the operability (sliding property).

[0072] The following explains more details. Figures 1 to 4 As shown, the sheath hub (valve housing) 21b of the sheath 21 is composed of a hub body 21c and a cover 21d. The valve container 24 extends from the proximal side of the hub body 21c to the distal side of the cover 21d. The cover 21d is fixed to the hub body 21c by, for example, an adhesive.

[0073] like Figure 4 and Figure 5 As shown, the first tapered recess 6 and the second tapered recess 7 are respectively formed on the outer (outer) surfaces of the first bulkhead 2 and the second bulkhead 3 along the central axial direction. Centering holes (guide holes) 8 and 9 are respectively provided at the inner ends of the first tapered recess 6 and the second tapered recess 7. A Y-shaped, cross-shaped slit (not shown) is cut through the first bulkhead 2 from the centering hole 8. A Y-shaped, cross-shaped slit (not shown) is cut through the second bulkhead 3 from the centering hole 9.

[0074] The first conical recess 6 formed in the first partition wall 2 is used as an introduction inclined surface for the insertion of a tubular introduction member such as a dilator or a catheter. The first conical recess 6 and the second conical recess 7 and the centering holes 8 and 9 are coated with fluorine. As described above, the lubricant storage 5 is composed of a flat cylindrical recess (having a diameter of about 5 mm and a depth of about 0.5 mm) formed on the inner (inner side) surface of the first partition wall 2 along the central axial direction. In other words, the lubricant storage 5 is formed by reducing the thickness of the first partition wall 2.

[0075] like Figure 6 , Fig. 7A and Figure 7B As shown, three grooves 10 for adhesive are formed at equal intervals along the central axis in the circumferential direction on the upper and lower arc surfaces of the outer circumferential surface of the first partition wall 2. Although not shown in the figure, the same type of grooves for adhesive are also formed on the outer circumferential surface of the second partition wall 3.

[0076] The first partition wall 2 and the second partition wall 3 are embedded in the valve container 24 in the sheath hub (valve housing) 21b of the sheath 21 after the adhesive is applied to the outer surface. Because the outer diameters of the first partition wall 2 and the second partition wall 3 are larger than the inner diameter (reverse dimension) of the valve container 24, most of the adhesive may be scraped off during embedding. This may reduce the adhesion between the first partition wall 2 and the second partition wall 3 and the valve container 24.

[0077] However, according to the configuration of the hemostatic valve 1 (the first partition wall 2 and the second partition wall 3), when the adhesive is applied, the adhesive is filled into the groove 10 for the adhesive formed on the outer peripheral surface of the first partition wall 2 and the second partition wall 3, etc., and the adhesive is not scraped off when embedded. Therefore, the reduction in the adhesive force between the first partition wall 2 and the second partition wall 3 and the valve container 24 can be minimized.

[0078] When the hemostatic valve 1 is embedded in the valve container 24, the opposite dimensions between the outer diameters of the first partition wall 2 and the second partition wall 3 and the inner diameter of the valve container 24 allow the hemostatic valve 1 (the first partition wall 2 and the second partition wall 3) to be tightened inward, thereby producing a sealing effect of the slit in the center.

[0079] The distance L between the inner end of the first tapered recess 6 and the inner end of the second tapered recess 7 is set to 1.2 mm to 10.0 mm (see Figure 5 ). According to this configuration, the sealing performance can be improved by the distance to further ensure that air is not sucked in.

[0080] like Figures 4 to 7A and Figure 7BAs shown, an upper semicircular position fixing hole 13 and a lower semicircular position fixing hole 14 are formed in pairs along the central axial direction on the outer edge of the outer side (outer side) of the first partition wall 2. On the proximal end surface of the valve container 24 in the cover 21d constituting the sheath hub (valve housing) 21b, an upper semicircular convex thread 15 and a lower semicircular convex thread 16 are respectively provided in pairs along the central axial direction, which fit into the position fixing holes 13, 14. After the first partition wall 2 is first accommodated in the valve container 24 in the cover 21d, the second partition wall 3 is accommodated in the valve container 24, and then the cover 21d is fixed to the hub body 21c with, for example, an adhesive, the hemostatic valve 1 is embedded in the valve container 24. In this case, the first partition wall 2 has the convex threads 15, 16 embedded in the position fixing holes 13, 14 on the valve container 24 side, and the second partition wall 3 is pressed toward the first partition wall 2 along the central axial direction by the distal end surface of the valve container 24.

[0081] According to this configuration, when the hemostatic valve 1 (the first partition wall 2 and the second partition wall 3) is embedded in the valve container 24 in the sheath hub (valve housing) 21b of the sheath 21, the convex threads 15, 16 of the valve container 24 are embedded in the position fixing holes 13, 14 of the first partition wall 2, and the second partition wall 3 is pressed toward the first partition wall 2. Therefore, the displacement (movement) of the first partition wall 2 and the second partition wall 3 around the central axis can be avoided. Therefore, the appropriate relative position of the first partition wall 2 and the second partition wall 3 around the central axis can be ensured, which can further improve the operability (slidability) when inserting and removing a tubular introduction member (such as a dilator or a catheter). In addition, the slits of the Y-shape, cross shape, etc. can be kept in the appropriate position to maintain the sealing performance.

[0082] When adhesive is applied to the outer peripheral surface of the first partition wall 2, the adhesive also flows inside the position fixing holes 13, 14, increasing the adhesive area and strengthening the fixing force of the first partition wall 2 to the valve container 24 of the sheath hub (valve housing) 21b.

[0083] like Figure 6 , Fig. 7A and Figure 7B As shown, on the outer peripheral surface of the first partition wall 2, grooves 19a and 19b for direction control are formed in pairs on the right and left sides along the central axis. Figure 4 2, in the valve container 24 in the cover 21d constituting the sheath hub (valve housing) 21b, a pair of straight convex threads are provided on the right and left sides, and the pair of straight convex threads are inserted into the grooves 19a, 19b for direction control. Although not shown in the figure, on the outer periphery of the second partition wall 3, a pair of grooves for direction control are formed on the right and left sides, respectively, and a pair of straight convex threads are inserted into the pair of grooves on the right and left sides, respectively.

[0084] According to this configuration, when the hemostatic valve 1 (the first partition wall 2 and the second partition wall 3) is embedded in the valve container 24 in the sheath hub (valve housing) 21b of the sheath 21, a pair of male threads are inserted into a pair of grooves 19a, 19b, etc. for direction control, so that the relative displacement of the first partition wall 2 and the second partition wall 3 around the central axis can be prevented or restricted. Therefore, if the slit cut into the first partition wall 2 and the second partition wall 3 is, for example, a cross shape (cross-cut), when the first partition wall 2 and the second partition wall 3 overlap each other, the slit becomes a "*" shape. This compensates for the cut side (weak point) when the thin tubular introduction member is inserted, so that the sealing performance can be improved.

[0085] also, Figures 1 to 4 The medical device 20 shown is provided with the above-mentioned hemostatic valve 1 (the first hemostatic valve 2 and the second hemostatic valve 3) so that the action and effect caused by the above-mentioned hemostatic valve 1 (the first partition wall 2 and the second partition wall 3) can be exerted.

[0086] How to use medical devices

[0087] The use of the medical device in one embodiment of the present disclosure will be briefly explained below.

[0088] For example, when a cardiac catheter is inserted from a blood vessel (vena cava) into the left atrium, the medical device 20 of this embodiment is used integrally with a dilator (not shown).

[0089] First, before the sheath tube 21a is inserted into the blood vessel, heparin-saline (normal saline) is injected into the sheath tube 21a through the three-way stopcock. After ensuring entry into the femoral vein, a guide wire is inserted into the superior vena cava, and the dilator and sheath tube 21a are inserted along the guide wire. When the tip of the dilator reaches the superior vena cava, the guide wire is removed and the septal puncture needle is inserted into the sheath tube 21a. Then, the septal puncture needle is used to puncture the atrial septum, so that the dilator and sheath tube 21a enter the left atrium, the dilator is removed, and the cardiac catheter is inserted and placed at the target site.

[0090] In this case, the rotary operation portion (turntable) 23 of the handle 22 is rotated as necessary to deflect the tip of the sheath tube 21 a and adjust the indwelling position of the cardiac catheter.

[0091] In the medical device 20 of the present embodiment, a hemostatic valve 1 is used as a hemostatic valve. The hemostatic valve 1 has a first partition wall 2 on the proximal side, and a second partition wall 3 on the distal side. The second partition wall 3 is arranged adjacent to the first partition wall 2. The hemostatic valve 1 has a lubricant storage 5, which is arranged between the first partition wall 2 and the second partition wall 3. The lubricant storage 5 can store a lubricant (see Figure 1 , Figure 2 , Figure 4), so that the slidability of the dilator, cardiac catheter, etc. can be maintained for a longer time. This also improves the sealing performance of the hemostatic valve 1 and avoids the risk of air inhalation.

[0092] In the present embodiment, the case where the valve is a hemostatic valve 1 for preventing blood leakage is taken as an example. However, the valve disclosed in the present invention is not necessarily limited to a hemostatic valve. The valve only needs to be a valve through which a tubular introduction member is inserted.

[0093] In this embodiment, as an example, the case where the tube member is an introducer sheath 21 is also described, and the introducer sheath 21 is used to, for example, insert a cardiac catheter from a blood vessel (vena cava) into the left atrium. However, the present disclosure is not necessarily limited to this configuration. As long as the tube member is flexible, the tube member can be any other tube member, such as a catheter or an endoscope tube.

[0094] In the present embodiment, as an example, the case where the groove 10 for the adhesive is formed along the central axial direction on the outer peripheral surface of the first partition wall 2 and the second partition wall 3, respectively, is described. However, the present disclosure is not necessarily limited to this configuration. The groove for the adhesive only needs to be formed on at least one of the first partition wall 2 and the second partition wall 3. For example, the groove for the adhesive can be formed along the circumference of the outer peripheral surface of the first partition wall 2 and / or the second partition wall 3.

[0095] In this embodiment, the hemostatic valve 1 is described using an example in which the first and second tapered recesses 6 and 7 are respectively formed along the central axis only on the outer (outer) surfaces of the first and second partition walls 2 and 3. However, the present disclosure is not necessarily limited to this configuration.

[0096] like Figure 8 As shown in FIG9 , a plurality of shallow concave lubricant reservoirs 27, 28 may be formed on the outer and inner (inner) surfaces of the first partition wall 2-1 along the central axial direction. Although not shown in the drawings, a plurality of shallow concave lubricant reservoirs may also be formed on the outer and inner surfaces of the second partition wall 3 along the central axial direction. The lubricant reservoir only needs to be formed on at least the outer surface of the first partition wall 2 and / or the second partition wall 3 along the central axial direction. For example, in addition to the shallow concave lubricant reservoir, a groove-shaped lubricant reservoir may also be formed.

[0097] According to this configuration, even when the lubricant is applied at least on the outer surface of the first partition wall 2 and / or the second partition wall 3 in the central axial direction, the lubricant is retained in the lubricant reservoirs 27, 28. Therefore, the lubricant is less likely to drip due to gravity during the manufacture of the valve to use or when the medical device 20 provided with the hemostatic valve 1 is used. Therefore, the lubricant applied at least to the outer surface of the first partition wall 2 and / or the second partition wall 3 in the central axial direction also helps to further improve the operability (sliding property) and the sealing performance (prevention of air inhalation) when inserting and removing a tubular introduction member (such as a dilator or a cardiac catheter).

[0098] In this embodiment, the case where the second tapered recess 7 is formed on the outer (outer) surface of the second partition wall 3 along the central axial direction is described as an example. However, the present disclosure is not necessarily limited to this configuration. Fig. 10A , Fig. 10B and Fig. 10C As shown, a barrel-shaped recess 17 having a flat bottom may be formed on the outer (outer) surface of the second partition walls 3-1, 3-2, 3-3 along the central axial direction. Fig. 10A In the embodiment, the diameter d1 of the barrel-shaped recess 17-1 is about 5 mm, and the thickness t1 of the valve portion of the second partition wall 3-1 is about 1 mm. Fig. 10B In the embodiment, the diameter d2 of the barrel-shaped recess 17-2 is about 6.5 mm, and the thickness t2 of the valve portion of the second partition wall 3-2 is about 0.5 mm. Fig. 10C , the diameter d3 of the barrel-shaped recess 17 - 3 is about 6.5 mm, and the thickness t3 of the valve portion of the second partition wall 3 - 3 is about 1 mm.

[0099] According to this configuration, the valve portions of the second partition walls 3 - 1 to 3 - 3 can be easily opened.

[0100] In this embodiment, as an example, a case is described where the lubricant reservoir 5 is constituted by a flat cylindrical recess formed along the central axial direction on the inner (inner side) face of the first partition wall 2. However, the present disclosure is not necessarily limited to this configuration.

[0101] like Fig.11 As shown, the third conical recess 4 can be further formed on the inner (inner side) surface of the second partition wall 3-4 along the central axial direction as a part of the lubricant reservoir. According to this configuration, for example, when inserting a braided or annular catheter, it is possible to restrict the braided or annular catheter from not advancing straight and mistakenly entering the lubricant reservoir. According to this configuration, the amount of lubricant can be further increased so that the slidability of the dilator, cardiac catheter, etc. can be maintained for an even longer period of time.

[0102] Only the third conical recess 4 can also constitute the lubricant reservoir. As described above, the lubricant reservoir 5 can be shaped and positioned differently. For example, the lubricant reservoir 5 can be composed of a flat cylindrical recess formed on the inner (inner) surface of the second partition wall 3 along the central axial direction. The lubricant reservoir 5 can be composed of a flat cylindrical recess formed on the inner (inner) surface of the partition walls 2, 3 along the central axial direction.

[0103] In this embodiment, as an example, a case is described where the semicircular position fixing holes 13, 14 are formed along the central axial direction at the outer edge of the (outer) face (near side) of the first partition wall 2. However, the present disclosure is not necessarily limited to this configuration.

[0104] like Fig.12 As shown, the semicircular position fixing holes 25, 26 may be formed on the outer edge of the outer (outer) surface (distal surface) of the second partition wall 3-5 along the central axial direction. The position fixing hole may be formed only in the second partition wall.

[0105] In addition to the position fixing holes 13 and 14, for example, a position fixing hole composed of a plurality of circular holes may be formed.

[0106] Description of Reference Numerals

[0107] 1: Hemostatic valve,

[0108] 2: First next door,

[0109] 3, 3-1, 3-2, 3-3, 3-4, 3-5: The second next door,

[0110] 5: Lubricant storage,

[0111] 6: The first tapered recess,

[0112] 7: Second tapered recess,

[0113] 8, 9: Centering hole (guide hole),

[0114] 10: Grooves for adhesive,

[0115] 13, 14, 25, 26: Position fixing holes,

[0116] 15, 16: Male thread,

[0117] 17-1, 17-2, 17-3: Barrel-shaped convex portion,

[0118] 19a, 19b: Grooves for directional control,

[0119] 20: Medical devices,

[0120] 21: Introducer sheath,

[0121] 21a: Sheath tube,

[0122] 21b: sheath hub (valve housing),

[0123] 21c: hub body,

[0124] 21d: Cover,

[0125] 21e side: port,

[0126] 21f: Insertion port,

[0127] 22: handle,

[0128] 23 a rotating operation part (turntable),

[0129] 24: Valve container,

[0130] 27, 28: Lubricant reservoir

Claims

1. A valve through which a tubular introduction member is inserted, the valve comprising: a first septum located on the proximal side; a second partition wall located at the far side, the second partition wall being arranged adjacent to the first partition wall; as well as A lubricant reservoir is provided between the first partition wall and the second partition wall, and has the ability to store lubricant. 2 . The valve according to claim 1 , further comprising a groove for an adhesive formed on an outer peripheral surface of the first partition wall and / or the second partition wall.

3. The valve according to claim 1, further comprising a lubricant reservoir formed at least on the outer (outer side) surface of the first partition wall and / or the second partition wall along a central axial direction. 4 . The valve according to claim 1 , further comprising a position fixing hole formed on an outer edge of the outer surface of the first partition wall and / or the second partition wall along the central axial direction. 5 . The valve according to claim 1 , further comprising a barrel-shaped recess having a flat bottom, the barrel-shaped recess being formed on a central axially outer (outer side) surface of the second partition wall in the central axial direction.

6. The valve according to claim 1 further includes a first conical recess and a second conical recess, wherein the first conical recess and the second conical recess are respectively formed on the outer (outer) surfaces of the first partition wall and the second partition wall along the central axis, and the distance between the inner end of the first conical recess and the inner end of the second conical recess is set to 1.2 mm to 10.0 mm.

7. The valve according to claim 1, wherein: The lubricant reservoir includes at least a third tapered recess formed on an inner (inner side) surface of the second partition wall along the central axial direction.

8. A medical device comprising a valve according to any one of claims 1 to 7.

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