Introducer

Abstract

[Problem] To provide: a valve capable of stably maintaining sealing properties to prevent leakage of air or blood while maintaining a smooth insertion feel even when various types of medical elongate bodies are repeatedly inserted and removed; and a medical instrument provided with the valve. [Solution] A valve 110 comprises a body part 115 which includes a first surface 111, a second surface 112 opposite the first surface, an outer peripheral surface 113 that extends between the first surface and second surface, and an insertion part 120 which is at least formed on the first surface and has an inner surface 123 that defines a gap 121 which enables insertion of a medical elongate body 300. The body part contains a self-repairing material capable of self-repairing damage created by contact with the medical elongate body, and at least a portion of the inner surface of the insertion part has a coating layer 125 formed thereon to prevent the gap from being closed by self-repair in a state in which portions of the inner surface of the insertion part contact each other.

Description

[Technical field]

[0001] The present invention relates to a valve body and a medical device including the valve body. For example, the medical device including the valve body is a sheath introducer, an introducer, and a connector member. [Background technology]

[0002] In catheter procedures, various devices are introduced into blood vessels through a valve body (hemostatic valve) arranged in the hub of a sheath introducer or a valve body (hemostatic valve) arranged in the hub of a connector member attached to the base end of a catheter. The sheath introducer is required to prevent air from entering the sheath introducer and reduce blood leakage from the base end of the sheath introducer. In addition, when various devices are introduced into blood vessels through a catheter that does not have a valve body, such as a guiding catheter, the connector member is required to be connected to the base end of the catheter to prevent air from entering the catheter and reduce blood leakage from the base end of the catheter. Therefore, various valve bodies are used in sheath introducers and connector members to prevent air embolism. For example, Patent Document 1 discloses a valve body formed with a slit that functions as an insertion part for introducing a medical elongated body, such as a catheter device or a guide wire, into the valve body. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] U.S. Patent Application Serial No. 14 / 710,417 Summary of the Invention [Problem to be solved by the invention]

[0004] In recent years, catheterization procedures have been used to diagnose and treat various lesions. In treating complex lesions, the surgeon inserts multiple types of medical elongated bodies with different product specifications such as outer diameters into blood vessels via a sheath introducer or a connector member, and manipulates the medical elongated bodies to treat the lesion. During the catheterization procedure, when inserting a dilator into a sheath introducer and when inserting a catheter device via a sheath introducer or a connector member, the surgeon needs to guide the medical elongated body toward the center of the valve body to prevent damage to the valve body. This may make the operation of the sheath introducer or connector member during the catheterization procedure complicated, which may lead to a longer catheterization procedure time. Hereinafter, in this specification, the catheter device, guidewire, dilator, etc. introduced into the living body via a sheath introducer or a connector member are collectively referred to as "medical elongated body".

[0005] Furthermore, if the valve body of the sheath introducer or connector member is damaged during a catheter procedure, the sheath introducer or connector member must be replaced, which impairs medical economics due to the cost of a new sheath introducer or connector member, the time lost due to inserting a new sheath introducer or attaching a new connector member, etc. Therefore, there is a demand for a valve body that can maintain ease of insertion when inserting a medical elongated object, while maintaining sealing properties even during harsh catheter manipulations.

[0006] The present invention has been made to solve the above-mentioned problems, and aims to provide a valve body and a medical device equipped with a valve body that can stably maintain a sealing performance to prevent air or blood leakage while maintaining a smooth insertion feel even when various types of medical elongated bodies are repeatedly inserted and removed. [Means for solving the problem]

[0007] The present invention Introducera valve body having a main body portion including a first surface, a second surface opposing the first surface, an outer circumferential surface extending between the first surface and the second surface, an inner surface defining a gap through which an elongated medical body can be inserted, and an insertion portion formed at least on the first surface, the main body portion including a self-repairing material capable of self-repairing damage caused by contact with the elongated medical body, and at least a part of the inner surface of the insertion portion is provided with a coating layer that prevents the gap from being closed by self-repairing when the inner surfaces of the insertion portions defining the gap are in contact with each other. a tubular member having an inner cavity through which the elongated medical body can be inserted, a hub having an internal space communicating with the inner cavity of the tubular member and in which the valve body is disposed and fixed to a base end side of the tubular member, and a cap member having a through hole through which the elongated medical body can be inserted and abutting against the valve body to fix the valve body to the internal space of the hub, wherein the valve body is compressed in a direction in which the inner surfaces of the insertion portions that define the gap come into contact with each other when the valve body is fixed to the internal space of the hub, and a dilator, the cap member through the through hole, and a dilator hub fixed to the base end side of the dilator body, and the coating layer is provided on at least a portion of the inner surface of the insertion portion to prevent the gap from closing by self-repairing when the dilator body is not inserted into the inner cavity of the tubular member of the sheath introducer through the through hole and the inner surfaces of the insertion portions which define the gap are in contact with each other. Effect of the Invention

[0008] In the valve body of the present invention, since the main body of the valve body contains a self-repairing material, even if the valve body is damaged when the operation of inserting the medical elongated body through the gap formed in the valve body is repeated several times, the damage to the valve body can be repaired by the self-repairing material. Therefore, the valve body can maintain the sealing property of the valve body. In addition, in the valve body of the present invention, a coating layer that suppresses the connection of the inner surfaces due to self-repair is provided on the inner surface that defines the gap in the insertion part, so that even if the inner surfaces of the insertion part are in contact with each other, the gap can be prevented from being closed by the self-repairing material. Therefore, the valve body of the present invention allows the surgeon to easily grasp the position of the insertion part of the valve body based on the gap formed in the valve body, and can suppress an increase in insertion resistance when the surgeon inserts the medical elongated body into the valve body. [Brief description of the drawings]

[0009] [Figure 1] FIG. 2 illustrates an introducer according to an embodiment. [Diagram 2] FIG. 2 is a cross-sectional view of a sheath introducer according to an embodiment. [Diagram 3] FIG. 2 is a perspective view of a valve body according to the embodiment. [Figure 4] FIG. 2 is a top view of a valve body according to the embodiment. [Diagram 5] 5A is a cross-sectional view of the valve body taken along the line 5A-5A shown in FIG. 3. [Figure 6]6A is a cross-sectional view of the valve body taken along the line 6A-6A shown in FIG. 3. [Figure 7] 1 is a cross-sectional view for explaining an example of use of a sheath introducer according to an embodiment. FIG. [Figure 8] 1 is a cross-sectional view for explaining an example of use of a sheath introducer according to an embodiment. FIG. [Figure 9] FIG. 13 is an exploded perspective view of a valve body according to Modification 1. [Figure 10] FIG. 11 is a cross-sectional view of a valve body according to Modification 2. [Figure 11] 13A and 13B are diagrams illustrating a connector member according to another embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Hereinafter, an introducer 10, a sheath introducer 100, and a valve body 110 according to this embodiment will be described with reference to Figs.

[0011] Fig. 1 shows a simplified overall configuration of the introducer 10. Fig. 2 shows a cross section along the axial direction of the sheath introducer 100, Figs. 3 and 4 show the valve body 110, Figs. 5 and 6 show cross-sectional views of the valve body 110, and Figs. 7 and 8 show examples of use of the sheath introducer 100.

[0012] In this specification, the side of the sheath introducer 100 where the hub 140 is disposed (upper side in FIG. 1) is referred to as the base end side. The side of the sheath introducer 100 that is positioned opposite the base end side and that is introduced into the living body (lower side in FIG. 1) is referred to as the tip side. The direction in which the tubular member 130 of the sheath introducer 100 extends (up and down direction in FIG. 1) is referred to as the axial direction.

[0013] As shown in FIG. 1, the introducer 10 includes a sheath introducer 100 and a dilator 200.

[0014] The sheath introducer 100 can be used to introduce a medical elongated body 300 (see Figure 8) such as a catheter device, a guide wire, or the dilator body 210 of the dilator 200 into a blood vessel through the inner lumen 131 of the tubular member 130.

[0015] (Valve body 110) The valve body 110 according to this embodiment can be disposed in an internal space 141 of a hub 140 of a sheath introducer 100, as shown in FIG.

[0016] The valve body 110 has a function of preventing air from flowing into the inner cavity 131 of the tubular member 130 from the outside, and a function of preventing blood that has flowed into the inner cavity 131 of the tubular member 130 from leaking to the outside.

[0017] 3, 4, 5, and 6, the valve body 110 has a main body 115 including a first surface 111, a second surface 112 facing the first surface 111, an outer circumferential surface 113 extending between the first surface 111 and the second surface 112, and an insertion portion 120 formed at least on the first surface 111, the main body 115 having an inner surface 123 defining a gap 121 that allows the insertion of the medical elongated body 300 (see FIG. 8). The main body 115 includes a self-repairing material capable of self-repairing damage caused by contact with the medical elongated body 300. At least a part of the inner surface 123 of the insertion portion 120 is provided with a coating layer 125 that suppresses the gap 121 from closing by self-repairing when the inner surfaces 123 of the insertion portions 120 are in contact with each other.

[0018] The valve body 110 is formed in a substantially circular membrane shape (disk shape). As shown in Fig. 2, the valve body 110 is fixed in the internal space 141 of the hub 140 by a cap member 150 fitted to the hub 140. The shape of the valve body 110 is not particularly limited as long as it can be placed in the internal space 141 of the hub 140.

[0019] The gap 121 can be configured by, for example, a slit formed in the main body portion 115, as shown in FIGS.

[0020] The slit forming the gap 121 has a first slit portion 121a extending from the first surface 111 side in the thickness direction of the main body portion 115 (the vertical direction in Figs. 5 and 6), and a second slit portion 121b extending from the second surface 112 side in the thickness direction of the main body portion 115. The first slit portion 121a and the second slit portion 121b intersect inside the main body portion 115, as shown in Figs. 5 and 6. The coating layer 125 can be provided on at least a part of the inner surface 123 that defines the first slit portion 121a.

[0021] 5, the first slit portion 121a has an arc shape that is curved convexly from the first surface 111 toward the center of the thickness direction of the main body portion 115. The second slit portion 121b has an arc shape that is curved convexly from the second surface 112 toward the center of the thickness direction of the main body portion 115.

[0022] 5 and 6, the bottom of first slit portion 121a located at approximately the center in the thickness direction of main body portion 115 is disposed so as to overlap with the upper end of second slit portion 121b located at approximately the center in the thickness direction of main body portion 115. As shown in Fig. 4, first slit portion 121a and second slit portion 121b cross each other in a plan view of main body portion 115. The angle at which first slit portion 121a and second slit portion 121b cross each other is not particularly limited.

[0023] The slit forming the gap 121 is not limited to a specific shape, etc., as long as the medical elongated body 300 can be inserted into the inside of the main body 115 from the first surface 111 side through the slit by being formed at least in the first surface 111. For example, the slit forming the gap 121 may have a linear shape extending at a substantially constant depth from the first surface 111 side along the thickness direction of the main body 115. In addition, the slit forming the gap 121 may have different shapes for the first slit portion 121a and the second slit portion 121b. For example, the first slit portion 121a may be formed as a slit having an arc shape, and the second slit portion 121b may be formed as a slit having a linear shape. In addition, when the slit forming the gap 121 is composed of a plurality of slit portions such as the first slit portion 121a and the second slit portion 121b, the slit portions 121a and 121b may not be in contact with each other inside the main body 115.

[0024] The self-repairing material contained in the main body 115 may be, for example, a self-repairing polymer.

[0025] The self-repairing polymer has a function (self-repairing ability) of re-adhering (rebonding) the cut surfaces of the polymer pieces when they are brought into contact with each other. Here, the self-repairing polymer is not particularly limited as long as it has the above function, and a known polymer can be used. Specifically, for example, a polymer having a bond formed by the interaction between a host group and a guest group (host-guest interaction) as a crosslinking point, such as those described in JP 2017-71710 A and WO 2017 / 159346 A, can be used. Here, the host group may be any that can include the guest group by interaction with the guest group, and examples of the host group include groups derived from compounds (host molecules) such as α-cyclodextrin, β-cyclodextrin, γ-cyclodextrin, calix[6]arenesulfonic acid, calix[8]arenesulfonic acid, 12-crown-4, 18-crown-6, [6]paracyclophane, [2,2]paracyclophane, cucurbit[6]uril, and cucurbit[8]uril. Among these, from the viewpoint of self-repairing property (guest group inclusion property), the host group is preferably a group derived from α-cyclodextrin, a group derived from β-cyclodextrin, or a group derived from γ-cyclodextrin, and more preferably a group derived from γ-cyclodextrin. In addition, the guest group may be any group that can be included in the host group by interaction with the host group, and examples thereof include hydrocarbon groups having 4 to 18 carbon atoms such as butyl group, hexyl group, cyclohexyl group, heptyl group, octyl group, nonyl group, decyl group, undecyl group, dodecyl group, tetradecyl group, pentadecyl group, hexadecyl group, heptadecyl group, octadecyl group, adamantyl group, and isobornyl group, and substituted hydrocarbon groups in which at least one hydrogen atom of the above-mentioned hydrocarbon group is substituted with a hydroxyl group, a carboxyl group, an amino group, a halogen atom, an ester group, an amide group, and the like. Among these, from the viewpoint of self-repairing properties (inclusion by the host group) and the like, the guest group is preferably a hydrocarbon group having 6 to 12 carbon atoms, preferably an n-butyl group, an n-hexyl group, an n-octyl group, an n-dodecyl group, an adamantyl group, or an isobornyl group, and more preferably an n-octyl group, an n-dodecyl group, an adamantyl group, or an isobornyl group.The host group and guest group may each be used alone or in combination of two or more kinds, and there is no particular limitation on the combination of the host group and the guest group. From the viewpoint of self-repairing property, the combinations of the host group and the guest group (host group-guest group) are (group derived from α-cyclodextrin-n-butyl group), (group derived from α-cyclodextrin-n-hexyl group), (group derived from α-cyclodextrin-n-octyl group), (group derived from α-cyclodextrin-n-dodecyl group), (group derived from β-cyclodextrin-adamantyl group), (group derived from β-cyclodextrin-hydroxyl group-substituted adamantyl group), (group derived from β-cyclodextrin-ethyl group-substituted adamantyl group), (group derived from β-cyclodextrin-isobornyl group), (group derived from γ-cyclodextrin-n-octyl group), (group derived from γ-cyclodextrin-n-dodecyl group). ) and (γ-cyclodextrin-derived group-cyclododecyl group) are preferred, (α-cyclodextrin-derived group-n-octyl group), (α-cyclodextrin-derived group-n-dodecyl group), (β-cyclodextrin-derived group-adamantyl group), (β-cyclodextrin-derived group-isobornyl group), (γ-cyclodextrin-derived group-n-octyl group), (γ-cyclodextrin-derived group-n-dodecyl group) and (γ-cyclodextrin-derived group-cyclododecyl group) are more preferred, and (γ-cyclodextrin-derived group-n-octyl group), (γ-cyclodextrin-derived group-n-dodecyl group) and (γ-cyclodextrin-derived group-cyclododecyl group) are even more preferred.

[0026] The self-repairing polymer according to the present embodiment may be synthesized by the method described in the above publication or may be a commercially available product. Examples of commercially available products include Wizard Gel (registered trademark), Wizard Pack Heat (Wizard Monomer SMH, Wizard Plus SW), and Wizard Pack Light (Wizard Monomer SMU, Wizard Plus PKU) (all manufactured by Yushiro Chemical Industry Co., Ltd.).

[0027] As the coating layer 125, for example, a self-repair inhibitor can be used that suppresses the inner surfaces 123 that define the gap 121 from connecting through self-repair when the inner surfaces 123 containing the self-repair material of the main body portion 115 are in contact with each other.

[0028] The self-repairing inhibitor has a function of preventing / suppressing (self-repairing inhibiting) re-adhesion (re-bonding) of the self-repairing material. Here, the self-repairing inhibitor is not particularly limited as long as it has the above function. For example, a compound having a guest group corresponding to the guest group present in the self-repairing material can be preferably used. When such a compound is applied to the inner surface 123 defining the gap 121, the guest group in the self-repairing inhibitor is included in the host group of the self-repairing material before the guest group in the self-repairing material interacts with the host group again (is included in the host group again) after the main body 115 is cut. This inhibits / prevents the interaction (inclusion) between the guest group and the host group of the self-repairing material after cutting, and inhibits / prevents re-adhesion (re-bonding) of the cut surface. The self-repairing inhibitor is preferably a compound having a structure of the guest group or a size similar to that of the guest group as described above, and a silicone compound is more preferably used from the viewpoint of ease of application. In addition, it is more preferable that the self-repairing inhibitor has the same group as the guest group present in the self-repairing material. This makes it possible to more effectively suppress and prevent the host-guest interaction of the self-repairing material (more effectively suppress and prevent re-adhesion (re-bonding) of the cut surface). That is, in a particularly preferred embodiment of this embodiment, the self-repairing inhibitor is a silicone compound (silicone oil) having at least one guest group present in the self-repairing material used or a structure having a size similar to that of the guest group. In particular, the silicone compound (silicone oil) is liquid and has fluidity. Therefore, when the self-repairing inhibitor is a silicone compound (silicone oil), the coating layer 125 is maintained on the inner surface 123 that defines the gap 121 while following the deformation of the main body 115, and therefore can preferably exhibit the ability to prevent / suppress re-adhesion (re-bonding) of the self-repairing material (self-repairing inhibition ability). In addition, when the medical elongated body 300 is inserted into the inside of the main body 115 through the slit that forms the gap 121, the coating layer 125 of the silicone compound (silicone oil) can also reduce the insertion resistance of the medical elongated body 300. Furthermore, since the silicone compound (silicone oil) does not require time for drying and hardening in the process of forming coating layer 125 on main body portion 115, coating layer 125 can be formed on main body portion 115 with a simple operation.The self-repair inhibitors may be used alone or in combination of two or more.

[0029] The entire body 115 of the valve body 110 may be made of a self-repairing material, or the self-repairing material may be contained only in the portion that forms the first surface 111 of the valve body 110. When a portion of the body 115 is made of a material other than the self-repairing material, for example, an elastic member such as silicone rubber, latex rubber, butyl rubber, or isoprene rubber may be used.

[0030] (Sheath Introducer 100) As shown in Figures 1 and 2, the sheath introducer 100 comprises the above-mentioned valve body 110, a tubular member 130 having an inner cavity 131 through which the medical elongated body 300 can be inserted, a hub 140 that communicates with the inner cavity 131 of the tubular member 130 and has an internal space 141 in which the valve body 110 is disposed and is fixed to the base end side of the tubular member 130, and a cap member 150 that has a through hole 151 through which the medical elongated body 300 can be inserted, and abuts against the valve body 110 to fix the valve body 110 to the internal space 141 of the hub 140.

[0031] The lumen 131 of the tubular member 130 extends in a substantially straight line from the base end side to the tip end side of the tubular member 130. A base end opening communicating with an internal space 141 of the hub 140 is formed at the base end of the tubular member 130. A tip opening enabling the medical elongated body 300 to be led out to the tip side of the tubular member 130 is formed at the tip of the tubular member 130. Note that in this embodiment, the dilator body 210 of the dilator 200 is exemplified as the medical elongated body 300.

[0032] A strain relief 160 that surrounds a predetermined range on the base end side of the tubular member 130 is connected to the hub 140. The hub 140 is also provided with a side port 142 that communicates with an internal space 141 of the hub 140. One end of a tube 180 (see FIG. 1) can be connected to the side port 142. The other end of the tube 180 can be connected to, for example, a three-way stopcock 170.

[0033] As shown in Figures 2 and 7, the valve body 110 is fixed in the internal space 141 of the hub 140 and compressed in a direction in which the inner surfaces 123 of the insertion portions 120 that define the gap 121 come into contact with each other (the direction indicated by the arrow A1 in Figures 7 and 8).

[0034] The cap member 150 has a protrusion 152 that presses the valve body 110 toward the tubular member 130 (in the direction indicated by the arrow B1 in FIGS. 7 and 8).

[0035] The cap member 150 is disposed at the base end of the hub 140. The cap member 150 is fitted to the base end of the hub 140 so as to surround a part of the outer circumferential surface of the hub 140. The cap member 150 may have a structure that allows it to be fixed to the hub 140 on the inside of the hub 140, for example. The fixing of the cap member 150 to the hub 140 is not limited to fitting, and may be, for example, screwing or bonding.

[0036] The hub 140 is formed with a step portion 143 that supports the outer periphery of the valve body 110 and holds the valve body 110 in the internal space 141. A first surface 111 of the valve body 110 is disposed on the cap member 150 side. A second surface 112 of the valve body 110 is disposed on the tubular member 130 side.

[0037] 2 and 7, the center C of the valve body 110 (the center in the plan view shown in FIG. 4) has a shape recessed toward the tubular member 130 when the valve body 110 is fixed in the internal space 141 of the hub 140 and pressed by the protrusion 152. In this state, the first surface 111 side of the valve body 110 is compressed in a direction in which the inner surfaces 123 of the insertion parts 120 that define the gap 121 come into contact with each other.

[0038] 2 and 7, the valve body 110 is compressed while being fixed in the internal space 141 of the hub 140. The coating layers 125 arranged on the inner surface 123 of the insertion part 120 that defines the gap 121 come into contact with each other as the valve body 110 is compressed.

[0039] The protrusion 152 sandwiches the outer periphery of the valve body 110 between itself and the step portion 143. The protrusion 152 is formed by an end of the cap member 150 located on the center side of the internal space 141 of the hub 140. The protrusion 152 has a cross-sectional shape that is inclined toward the tubular member 130. Note that the cross-sectional shape and the like of the protrusion 152 are not particularly limited as long as it is possible to press the valve body 110 fixed in the internal space 141 of the hub 140 toward the tubular member 130.

[0040] Examples of materials that can be used for the tubular member 130 include polymeric materials such as polyolefins (e.g., polyethylene, polypropylene, polybutene, ethylene-propylene copolymers, ethylene-vinyl acetate copolymers, ionomers, or mixtures of two or more of these), polyolefin elastomers, crosslinked polyolefins, polyvinyl chloride, polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, fluororesins (e.g., polytetrafluoroethylene, tetrafluoroethylene-ethylene copolymers), polycarbonates, polystyrenes, polyacetals, polyimides, polyetherimides, polyetheretherketones, and mixtures of these.

[0041] Examples of materials that can be used for the hub 140 and the cap member 150 include polyolefins such as polyethylene and polypropylene, polyamides, polycarbonates, and polystyrene.

[0042] (Dilator 200) As shown in FIG. 1, the dilator 200 has a dilator body 210 that can be inserted into the inner cavity 131 of the tubular member 130 of the sheath introducer 100 via the through hole 151 of the cap member 150, and a dilator hub 220 that is fixed to the base end side of the dilator body 210.

[0043] The dilator 200 can be used to prevent the tubular member 130 of the sheath introducer 100 from bending and to enlarge the diameter of a perforation in the skin when the tubular member 130 is inserted into a blood vessel.

[0044] When the dilator body 210 is inserted into the lumen 131 of the tubular member 130, the tip of the dilator body 210 protrudes from the tip opening of the tubular member 130 by a predetermined length.

[0045] The tip of the dilator body 210 is formed in a tapered shape tapering toward the tip side. The portion of the dilator body 210 located on the base end side from the tip of the dilator body 210 extends in the axial direction with a substantially constant outer diameter.

[0046] In this embodiment, the thickness t1 (see Figs. 3, 5, and 6) of the main body of the valve body 110 is smaller than the diameter of the maximum outer diameter part of the dilator body 210. The maximum outer diameter part of the dilator body 210 can be defined as any part located on the base end side of the tip part of the dilator body 210 to which a tapered shape is imparted. The diameter of the maximum outer diameter part of the dilator body 210 can be formed to be, for example, 1.0 mm to 6.0 mm. The thickness t1 of the main body part of the valve body 110 can be formed to be, for example, 1.2 mm to 10.0 mm.

[0047] Examples of materials that can be used for the dilator body 210 include polymeric materials such as polyolefins (e.g., polyethylene, polypropylene, polybutene, ethylene-propylene copolymers, ethylene-vinyl acetate copolymers, ionomers, or mixtures of two or more of these), polyolefin elastomers, crosslinked polyolefins, polyvinyl chloride, polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, fluororesins (e.g., polytetrafluoroethylene, tetrafluoroethylene-ethylene copolymers, etc.), polycarbonates, polystyrenes, polyacetals, polyimides, and polyetherimides, or mixtures of these materials.

[0048] Examples of materials that can be used for the dilator hub 220 include polyolefins such as polyethylene and polypropylene, polyamides, polycarbonates, and polystyrene.

[0049] As shown in Fig. 7, when inserting the medical elongated body 300 into the lumen 131 of the tubular member 130, the surgeon inserts the medical elongated body 300 into the internal space 141 of the hub 140 via the through-hole 151 of the cap member 150. As shown in Fig. 8, the surgeon introduces the medical elongated body 300 into the inside of the valve body 110 by passing it through the through-hole 151 of the cap member 150. The valve body 110 is disposed in the hub 140 with the center C of the valve body 110 curved concavely toward the tubular member 130. Therefore, when inserting the medical elongated body 300 into the inside of the valve body 110, the surgeon can easily guide the medical elongated body 300 from the first surface 111 side to the center C of the valve body 110.

[0050] When the surgeon brings the medical elongated body 300 into contact with a portion of the valve body 110 other than the center C, the valve body 110 may be damaged, such as torn. Even if such damage occurs, the valve body 110 can repair the damage by the self-repairing material contained in the main body 115. In addition, at least a part of the inner surface 123 of the insertion part 120 is provided with a coating layer 125 that suppresses the gap (slit) 121 from closing by self-repair. Therefore, the valve body 110 can suppress the gap 121 formed in the first surface 111 from closing during the period from the time of manufacture to the time of use by the surgeon, before the valve body 110 is used in a procedure, during the procedure after the medical elongated body 300 is temporarily removed and before a different medical elongated body 300 is reinserted into the valve body 110, and the like. Therefore, the surgeon can easily insert the medical elongated body 300 into the inside of the valve body 110 through the gap 121 formed in the first surface 111.

[0051] As described above, the valve body 110 according to this embodiment has a main body 115 including a first surface 111, a second surface 112 facing the first surface 111, an outer circumferential surface 113 extending between the first surface 111 and the second surface 112, and an insertion portion 120 formed at least on the first surface 111, the main body 115 having an inner surface 123 defining a gap 121 that allows the insertion of the medical elongated body 300. The main body 115 includes a self-repairing material capable of self-repairing damage caused by contact with the medical elongated body 300. At least a part of the inner surface 123 of the insertion portion 120 is provided with a coating layer 125 that suppresses the gap 121 from closing by self-repairing when the inner surfaces 123 of the insertion portions 120 are in contact with each other.

[0052] In the valve body 110 configured as described above, since the main body 115 of the valve body 110 contains a self-repairing material, even if the valve body 110 is damaged when the operation of inserting the medical elongated body 300 through the gap 121 formed in the valve body 110 is repeated multiple times, the damage to the valve body 110 can be repaired by the self-repairing material. Therefore, the valve body 110 can maintain the sealing property of the valve body 110. Furthermore, since the coating layer 125 is provided on the inner surface 123 that defines the gap 121 in the insertion part 120 of the valve body 110, even if the inner surfaces 123 of the insertion parts 120 are in contact with each other, the self-repairing material contained in the valve body 110 can prevent the inner surfaces 123 from being connected to each other and the gap 121 from being closed. Therefore, the valve body 110 allows the surgeon to easily grasp the position of the insertion portion 120 of the valve body 110 based on the gap 121 formed in the valve body 110, and also suppresses an increase in insertion resistance when the surgeon inserts the medical elongated body 300 into the valve body 110.

[0053] Moreover, the gap 121 is a slit formed at least in the first surface 111. The surgeon can smoothly insert the medical elongated body 300 into the valve body 110 through the slit formed in the first surface 111 of the valve body 110.

[0054] Further, the slit forming the gap 121 has a first slit portion 121a extending from the first surface 111 side in the thickness direction of the main body portion 115, and a second slit portion 121b extending from the second surface 112 side in the thickness direction of the main body portion 115. The first slit portion 121a and the second slit portion 121b intersect inside the main body portion 115. The coating layer 125 is provided at least on the inner surface 123 that defines the first slit portion 121a. Since the valve body 110 is constituted by the first slit portion 121a and the second slit portion 121b whose slits intersect inside the main body portion 115, it is possible to reduce the insertion resistance when the medical elongated body 300 is inserted through the valve body 110. Furthermore, since the valve body 110 has the coating layer 125 provided on the inner surface 123 that defines the first slit portion 121a, the first slit portion 121a formed on the first surface 111 can be effectively prevented from being closed due to contact between the inner surfaces 123.

[0055] The self-repairing material can be made of a polymer material including a cross-linked bond formed by the interaction between a host group and a guest group. The host group can be made of γ-cyclodextrin. The guest group can be made of at least one group selected from the group consisting of an adamantyl group and a dodecyl group. Since the self-repairing material contained in the main body 115 is made of the above-mentioned material, the valve body 110 can more reliably repair damage formed in the valve body 110 due to contact with the medical elongated body 300.

[0056] The sheath introducer 100 according to this embodiment includes a valve body 110, a tubular member 130 having a lumen 131 through which the elongated medical body 300 can be inserted, a hub 140 that communicates with the lumen 131 of the tubular member 130, has an internal space 141 in which the valve body 110 is disposed, and is fixed to the base end side of the tubular member 130, and a cap member 150 that has a through hole 151 through which the elongated medical body 300 can be inserted, and abuts against the valve body 110 to fix the valve body 110 to the internal space 141 of the hub 140. When the valve body 110 is fixed to the internal space 141 of the hub 140, it is compressed in a direction in which the inner surfaces 123 of the insertion sections 120 that define the gap 121 come into contact with each other.

[0057] In the sheath introducer 100 configured as described above, when the valve body 110 is fixed to the internal space 141 of the hub 140, the valve body 110 is compressed in a direction in which the inner surfaces 123 of the insertion section 120 that define the gap 121 come into contact with each other. Since the valve body 110 is provided with the coating layer 125 on at least a part of the inner surface 123 of the insertion section 120, which inhibits the gap 121 from closing by self-repair, even when the valve body 110 is compressed and fixed to the hub 140, the gap 121 can be inhibited from closing.

[0058] The cap member 150 also has a protrusion 152 that presses the valve body 110 toward the tubular member 130. The center C of the valve body 110 is recessed toward the tubular member 130 when the valve body 110 is fixed to the internal space 141 of the hub 140 and pressed by the protrusion 152. The first surface 111 side of the valve body 110 is compressed in a direction in which the inner surfaces 123 of the insertion parts 120 that define the gap 121 come into contact with each other. When the valve body 110 is fixed to the internal space 141 of the hub 140, the center C of the valve body 110 is curved in a concave shape toward the tubular member 130. Therefore, when the surgeon inserts the medical elongated body 300 into the valve body 110, the surgeon can easily guide the medical elongated body 300 from the first surface 111 side to the center C of the valve body 110.

[0059] The valve body 110 is compressed while being fixed in the internal space 141 of the hub 140. In the valve body 110, the coating layers 125 arranged on the inner surfaces 123 of the insertion parts 120 that define the gap 121 come into contact with each other as the valve body 110 is compressed. Therefore, in a state in which the valve body 110 is fixed in the internal space 141 of the hub 140, the coating layers 125 arranged on the inner surfaces 123 of the insertion parts 120 can be prevented from chemically re-adhering (re-bonding) to each other while ensuring a physical close contact state between the coating layers 125 arranged on the inner surfaces 123 of the insertion parts 120. Therefore, in a state in which the valve body 110 is fixed in the internal space 141 of the hub 140, the inner surfaces 123 of the insertion parts 120 of the valve body 110 are closed, so that the valve body 110 can reliably prevent blood leakage.

[0060] The introducer 10 according to this embodiment includes a sheath introducer 100 and a dilator 200. The dilator 200 includes a dilator body 210 that can be inserted into the lumen 131 of the tubular member 130 of the sheath introducer 100 through the through hole 151 of the cap member 150, and a dilator hub 220 that is fixed to the base end side of the dilator body 210. The thickness of the main body 115 of the valve body 110 is smaller than the diameter of the maximum outer diameter of the dilator body 210. According to the valve body 110 according to this embodiment, the self-repairing material contained in the main body 115 can improve the sealing property of the valve body 110. Therefore, even when the thickness of the valve body 110 is reduced, the sealing property of the valve body 110 can be maintained well. Therefore, the thickness of the valve body 110 can be formed to be smaller than the diameter of the maximum outer diameter of the dilator body 210, for example. This allows the valve body 110 to be made smaller in size.

[0061] Next, a valve body according to a modified example will be described. In the modified example, duplicated explanations of the contents already explained will be omitted. Furthermore, the contents not specifically explained in the modified example can be the same as those in the above-mentioned embodiment.

[0062] <Variation 1> FIG. 9 shows a perspective view of a valve body 110A according to the first modification.

[0063] The valve body 110A can be composed of two main body portions, a first main body portion 410 and a second main body portion 420, for example.

[0064] The first body portion 410 has a first surface 411 , a second surface 412 , and an outer circumferential surface 413 extending between the first surface 411 and the second surface 412 .

[0065] The second body portion 420 has a first surface 421 , a second surface 422 , and an outer circumferential surface 423 extending between the first surface 421 and the second surface 422 .

[0066] The first body portion 410 and the second body portion 420 can be arranged in an overlapping manner in the internal space 141 of the hub 140. The second surface 412 of the first body portion 410 can be arranged facing the first surface 421 of the second body portion 420 in the internal space 141 of the hub 140. The two body portions 410, 420 arranged in this manner can form the body portion 115 of the valve body 110A. The first surface 411 of the first body portion 410 forms the first surface 111 of the body portion 115. The second surface 422 of the second body portion 420 forms the second surface 112 of the body portion 115. The outer peripheral surface 113 of the body portion 115 is formed by the outer peripheral surface 413 of the first body portion 410 and the outer peripheral surface 423 of the second body portion 420 arranged in an overlapping manner.

[0067] A first slit portion 121a extending in the thickness direction of the first main body portion 410 is formed on the first surface 411 of the first main body portion 410. The first slit portion 121a extends to a length that reaches from the first surface 411 to the second surface 412. A second slit portion 121b extending in the thickness direction of the second main body portion 420 is formed on the second surface 422 of the second main body portion 420. The second slit portion 121b extends to a length that reaches from the second surface 422 to the first surface 411. Each of the slit portions 121a, 121b constitutes a slit that forms the gap 121.

[0068] As with the above-described valve body 110, the valve body 110A according to the first modification has a coating layer provided on at least a part of the inner surface of the insertion portion 120 of the valve body 110A, which prevents the gap 121 from being closed by the self-repairing material. Therefore, according to the valve body 110A, the surgeon can easily grasp the position of the insertion portion 120 of the valve body 110A based on the gap 121 formed in the valve body 110A, and an increase in insertion resistance when the surgeon inserts the medical elongated body 300 into the valve body 110A can be suppressed.

[0069] <Variation 2> FIG. 10 shows a cross-sectional view of a valve body 110B according to the second modification.

[0070] In the valve body 110B according to the second modification, the gap 121 is configured as a hole. The hole forming the gap 121 penetrates the main body 115 of the valve body 110B along the thickness direction of the main body 115. A coating layer 125 is provided on the inner surface 123 of the insertion part 120 that defines the hole. As shown in this modification, the specific structure of the gap 121 is not particularly limited as long as it is configured so that the medical elongated body 300 can be inserted into the main body 115 of the valve body 110B.

[0071] In addition, when the valve body 110B is fixed in the internal space 141 (see FIG. 2) of the hub 140, the hole forming the gap 121 is compressed toward the center C of the valve body 110B, so that the inner surfaces 123 defining the hole come into contact with each other. The coating layer 125 provided on the inner surfaces 123 can prevent the inner surfaces 123 defining the hole from being connected and closing the hole.

[0072] <Other Modifications> The valve body according to the present invention may have an insertion portion having an inner surface defining a gap (e.g., a slit or hole) formed in at least a part of the first surface of the valve body (the surface that is disposed on the cap member 150 side when applied to the sheath introducer 100). Therefore, the gap does not have to be formed over the entire thickness direction of the valve body. However, from the viewpoint of preventing a significant decrease in the insertability of the medical elongated body 300 into the valve body, it is preferable that the gap has a length from the first surface that is equal to or greater than half the thickness of the main body.

[0073] <Other embodiments> Next, a connector member according to another embodiment will be described. In this embodiment, duplicated descriptions of the contents already described will be omitted. In addition, the contents not specifically described in this embodiment can be the same as those in the above-mentioned embodiment and each modified example.

[0074] 11 shows a connector member 500 including a valve body 110. The connector member 500 can be used by connecting it to a catheter (e.g., a guiding catheter) including a hub in which the valve body 110 is not disposed. By connecting the connector member 500 to a hub disposed at the base end of the catheter, in a state in which a medical elongated body (such as a guidewire or other catheter device) used in combination with the catheter is inserted through the valve body 110, the connector member 500 can prevent air from flowing into the catheter and reduce blood leakage from the base end of the catheter. Note that the specific structure, type, etc. of the catheter to which the connector member 500 is applied are not particularly limited.

[0075] The connector member 500 has a hub 540. The hub 540 has a main body portion 540a and a connector portion 540b.

[0076] The main body 540a has an internal space 541 in which the valve body 110 is disposed. A step portion (not shown) for holding the valve body 510 is provided in the internal space 541. A cap member 550 for holding the valve body 110 in the internal space 541 is attached to the hub 540. The cross-sectional shape and structure of the internal space 541 of the hub 540 of the connector member 500 and the cross-sectional shape and structure of the cap member 550 can be similar to those of the hub 140 and the cap member 150 (see FIG. 2) of the sheath introducer 100 according to the embodiment described above, for example.

[0077] The main body 540a is provided with a side port 542 that communicates with the internal space 541. One end of a tube 180 can be connected to the side port 542. The other end of the tube 180 can be connected to, for example, a three-way stopcock 170. The connector member 500 does not necessarily have to include the tube 180 and the three-way stopcock 170.

[0078] The connector portion 540b has a male connector portion 545 protruding in a convex shape from the main body portion 540a, and a screw adapter portion 546 rotatably held by the male connector portion 545. The screw adapter portion 546 is connected to the male connector portion 545 in a state in which it is prevented from coming off. The screw adapter portion 546 can move a predetermined distance along the axial direction in which the male connector portion 545 extends. With the male connector portion 545 inserted into the hub of the catheter, the surgeon can fix the connector member 500 to the hub of the catheter by rotating and moving the screw adapter portion 546 in the axial direction. Note that a specific configuration for fixing the connector portion 540b to the hub of the catheter is not particularly limited.

[0079] In the connector member 500 according to the present embodiment, the coating layer 125 is provided on the inner surface 123 that defines the gap 121 in the insertion portion 120 of the valve body 110, so that even when the inner surfaces 123 of the insertion portions 120 are in contact with each other, the self-repairing material contained in the valve body 110 can prevent the inner surfaces 123 from being connected to each other and the gap 121 from being closed. Therefore, the valve body 110 allows the surgeon to easily grasp the position of the insertion portion 120 of the valve body 110 based on the gap 121 formed in the valve body 110, and can prevent an increase in insertion resistance when the surgeon inserts the medical elongated body into the valve body 110. By connecting the connector member 500 to a catheter that does not have a valve body 110, the surgeon can prevent air from entering the catheter when the catheter is used, and can reduce blood leakage from the base end of the catheter.

[0080] The valve body, sheath introducer, and connector member according to the present invention have been described above through embodiments and modified examples. However, the present invention is not limited to the respective configurations described above, and may be modified as appropriate based on the description of the claims.

[0081] The structure of each part and the arrangement of components described in the specification may be modified as appropriate, and the use of additional components described in the figures may be omitted or other additional components may be used as appropriate.

[0082] This application is based on Japanese Patent Application No. 2019-217241 filed on November 29, 2019, the disclosure of which is incorporated by reference in its entirety. [Explanation of symbols]

[0083] 10. Introducer 100 Sheath Introducer 110, 110A, 110B Valve body 111 1st surface 112 Second surface 113 Outer surface 115 Main body 120 Insertion section 121 Gap (slit, hole) 121a First slit section 121b Second slit section 123 Inside 125 Covering layer 130 Tubular member 131 Luminal part 140 Hub 141 Interior Space 150 Cap member 151 Through hole 152 Convex 200 Dilator 210 Dilator body 220 Dilator Hub 300 Medical long body 410 First body part 420 Second body part 500 Connector parts C Center of valve body t1 Thickness of valve body

Claims

1. A first surface; and a second surface opposite the first surface; and a circumferential surface extending between the first surface and the second surface; and a main body portion having an inner surface defining a gap through which a medical elongate object can be inserted, and an insertion portion formed at least on the first surface; the main body portion includes a self-repairing material capable of self-repairing damage caused by contact with the medical elongated body, a valve body, wherein a coating layer is provided on at least a portion of the inner surface of the insertion portion, the coating layer suppressing the gap from closing by self-repairing when the inner surfaces of the insertion portions that define the gap are in contact with each other; a tubular member having an inner cavity through which the medical elongated body can be inserted; a hub fixed to a proximal end side of the tubular member, the hub communicating with the inner cavity of the tubular member and including an internal space in which the valve body is disposed; a cap member that has a through hole through which the medical elongated body can be inserted and that abuts against the valve body to fix the valve body in the internal space of the hub, a sheath introducer, wherein the valve body is compressed in a direction in which the inner surfaces of the insertion portions that define the gap come into contact with each other in a state where the valve body is fixed in the internal space of the hub; A dilator, The dilator is a dilator body that can be inserted into the lumen of the tubular member of the sheath introducer through the through hole of the cap member; A dilator hub fixed to a proximal end side of the dilator body, An introducer in which the coating layer is provided on at least a portion of the inner surface of the insertion portion to prevent the gap from closing by self-repairing when the dilator body is not inserted into the inner cavity of the tubular member of the sheath introducer through the through hole and the inner surfaces of the insertion portions which define the gap are in contact with each other.

2. The introducer of claim 1 , wherein the gap is a slit or hole formed in at least the first surface.

3. The slit has a first slit portion extending from the first surface side in a thickness direction of the main body portion and a second slit portion extending from the second surface side in the thickness direction of the main body portion, the first slit portion and the second slit portion intersect inside the main body portion, The introducer according to claim 2 , wherein the coating layer is provided at least on the inner surface that defines the first slit portion.

4. The self-repairing material is a polymeric material that includes crosslinks formed by interactions between host groups and guest groups; the host group is γ-cyclodextrin; The introducer according to any one of claims 1 to 3, wherein the guest group is at least one selected from the group consisting of an adamantyl group and a dodecyl group.

5. the cap member has a protrusion that presses the valve body toward the tubular member, a center portion of the valve body is recessed toward the tubular member when the valve body is fixed in the internal space of the hub and pressed by the protrusion, The introducer according to claim 1 , wherein the first surface side of the valve body is compressed in a direction in which the inner surfaces of the insertion portions that define the gap come into contact with each other.

6. The introducer of claim 5, wherein the valve body is compressed while being fixed in the internal space of the hub, and the coating layers disposed on the inner surfaces of the insertion portion that define the gap come into contact with each other as the valve body is compressed.

7. The introducer according to any one of claims 1 to 6, wherein a thickness of the main body portion of the valve body is smaller than a diameter of a maximum outer diameter portion of the dilator body.

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