Valve structure and sheath for introducer

Abstract

To provide a valve structure and an introducer sheath that can exhibit high sealing performance and excellent operability. [Solution] The valve structure 120 includes a housing 130 having a lumen 135 and a housing portion 137 communicating with the lumen, and a valve body 140 disposed in the lumen of the housing and having an insertion portion 145 through which other medical instruments 300 can be inserted. The housing includes a wall structure having a housing portion that accommodates a part of the valve body when another medical instrument is inserted into the insertion portion of the valve body and the valve body deforms.

Description

Technical Field

[0001] The present invention relates to a valve structure and an introducer sheath.

Background Art

[0002] In procedures using a catheter or the like, an introducer is used as a medical instrument for forming an access path into a living body lumen such as a blood vessel. A general introducer includes an introducer sheath and a dilator. The introducer sheath includes a sheath portion (sheath tube) formed with a lumen into which a guide wire or a catheter device (hereinafter collectively referred to as "medical instruments") can be inserted, and a housing connected to the sheath portion.

[0003] A valve body (check valve) is disposed in the housing to prevent various liquids (e.g., blood, contrast agent, physiological saline, etc.) from leaking out of the introducer sheath through the housing when the medical instrument is inserted into the sheath portion.

[0004] In the introducer sheath described in Patent Document 1, an expandable and contractible balloon disposed in the housing is used as a valve mechanism. Before and after inserting the medical instrument into the housing and the sheath portion, an operator can inject fluid into the balloon to expand it, thereby closing the space between the medical instrument and the balloon. By this operation, it is possible to transition to a sealed state (closed state) that prevents liquid from leaking out of the introducer sheath through the housing.

[0005] In addition, in the introducer sheath described in Patent Document 1, since the balloon is used as a valve mechanism, by adjusting the expansion amount of the balloon, it is possible to respond to the following procedures.

[0006] In procedures involving the insertion of multiple medical devices (catheters) into blood vessels, introducer sheaths are sometimes inserted into relatively large-diameter blood vessels running through the lower limbs. The introducer sheath, with its enlarged diameter, allows for the simultaneous use of multiple medical devices. Furthermore, to access multiple side openings in biological organs, procedures may involve the simultaneous insertion of multiple guidewires, contrast catheters, stent delivery catheters, etc., into a large-diameter sheath. The introducer sheath described in Patent Document 1 allows for the occlusion of the space between each medical device and the balloon by adjusting the balloon expansion amount, even when multiple medical devices are inserted into the sheath simultaneously. Therefore, it is considered possible to maintain high sealing performance even when the sheath is enlarged. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] Japanese Patent Publication No. 2022-27860 [Overview of the project] [Problems that the invention aims to solve]

[0008] However, since the introducer sheath described in Patent Document 1 employs a balloon as a valve mechanism, when closing the space between the medical device and the balloon, the balloon must be expanded by operating a fluid supply device such as a syringe. Furthermore, when releasing the seal, the balloon must be deflated by operating the fluid supply device each time. Consequently, the procedure using the introducer sheath becomes complicated.

[0009] This invention has been made in view of the above problems, and aims to provide a valve structure and an introducer sheath that can exhibit high sealing performance and have excellent operability. [Means for solving the problem]

[0010] The present invention can be achieved by any one of the means described in (1) to (6) below.

[0011] (1) A valve structure used in medical devices inserted into blood vessels, A housing comprising a lumen and a housing portion communicating with the lumen, The housing has a valve body disposed within the lumen and having an insertion portion through which other medical instruments can be inserted, The housing is a valve structure having a wall structure having a housing portion that accommodates a part of the valve body when the valve body deforms due to the insertion portion of the valve body being inserted into the insertion portion of the valve body.

[0012] (2) The valve structure according to (1), wherein the housing portion is an opening that connects the lumen to the outside of the housing.

[0013] (3) The valve structure according to (1), wherein the housing portion is a recess that is recessed outward in the direction perpendicular to the axial direction when viewed from the axial center side of the valve body.

[0014] (4) The valve structure according to any one of (1) to (3), wherein the housing is made of a member that can deform together with the valve body when the valve body deforms.

[0015] (5) The valve structure according to any one of (1) to (4), having a film-like sealing portion disposed to cover at least a portion of the surface of the valve body.

[0016] (6) A valve structure described in any one of (1) to (5), An introducer sheath comprising a sheath tube connected to the housing at a position closer to the tip than the position where the valve body is located. [Effects of the Invention]

[0017] According to the present invention, it is possible to provide a valve structure and an introducer sheath that can exhibit high sealing performance and excellent operability.

Brief Description of the Drawings

[0018] [Figure 1] It is a diagram showing an introducer according to an embodiment. [Figure 2] It is a partial cross-sectional view showing a valve structure of an introducer sheath according to an embodiment, and is a diagram showing a state before inserting another medical instrument into the valve structure. [Figure 3] It is a perspective view showing the appearance of the housing. [Figure 4] It is a plan view of the valve body as viewed from the direction of arrow 4A shown in FIG. 2. [Figure 5] It is a partial cross-sectional view showing a valve structure of an introducer sheath according to an embodiment, and is a diagram showing a state when another medical instrument is inserted into the valve structure. [Figure 6] It is a partial cross-sectional view showing a valve structure according to Modification 1. [Figure 7] It is a partial cross-sectional view showing a valve structure according to Modification 2. [Figure 8] It is a partial cross-sectional view showing a valve structure according to Modification 3. [Figure 9] It is a partial cross-sectional view showing a valve structure according to Modification 4. [Figure 10] It is a perspective view showing a structural example of the housing. [Figure 11] [[ID=四十一]]It is a perspective view showing a structural example of the housing. [Figure 12] It is a perspective view showing a structural example of the housing. [Figure 13] It is a perspective view showing a structural example of the housing.

Mode for Carrying Out the Invention

[0019] Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown herein are illustrative examples to embody the technical idea of ​​the present invention and do not limit the present invention. Furthermore, all other implementable forms, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included in the scope and spirit of the present invention, as well as in the claims and their equivalents.

[0020] Furthermore, the drawings attached to this specification may be schematically represented with changes to scale, aspect ratio, shape, etc., from the actual object for the sake of illustration and ease of understanding, but these are merely examples and do not limit the interpretation of the present invention.

[0021] Furthermore, in the following explanations, ordinal numbers such as "1st" and "2nd" are used, but unless otherwise specified, they are used for convenience and do not prescribe any particular order.

[0022] (Embodiment) The introducer sheath 100 according to this embodiment will be described with reference to Figures 1 to 5. In this specification, the present invention will be described through an introducer 10 that includes the introducer sheath 100 and the dilator 200 as components.

[0023] Figure 1 shows the introducer 10, and Figures 2 and 5 are partial cross-sectional views (partial cross-sectional views along the axial direction) of the valve structure 120 of the introducer sheath 100. Figure 3 is a perspective view of the housing 130, and Figure 4 is a plan view of the valve body 140 as seen from the direction of arrow 4A in Figure 2.

[0024] For the sake of clarity, the following directions are defined in this specification.

[0025] In the introducer sheath 100, the side where the housing 130 is located (the upper side in Figures 1 and 2) is defined as the "proximal end." In the introducer sheath 100, the side opposite to the proximal end and inserted into the body (the lower side in Figures 1 and 2) is defined as the "proximal end." The direction in which the sheath tube 110 of the introducer sheath 100 extends (the vertical direction in Figures 1 and 2) is defined as the axial direction. Furthermore, "proximal end" refers to the portion including a certain range extending from the tip (frontmost point) towards the proximal end, and "proximal end" refers to the portion including a certain range extending from the proximal end (very basal end) towards the proximal end. The arrows X1-X2 in each figure indicate the axial direction of the introducer sheath 100, and the arrows Y1-Y2 indicate the depth direction perpendicular to the axial direction.

[0026] (Introducer 10) As shown in Figure 1, the introducer 10 includes an introducer sheath 100 and a dilator 200.

[0027] The introducer sheath 100 can be used to introduce the dilator body 210 (dilator tube) of the dilator 200 or various medical devices (e.g., catheter devices, guidewires, etc.) into a blood vessel via the lumen 115 (see Figure 2) of the sheath tube 110. In this embodiment, medical devices (including the dilator 200) through which the valve body 140 of the valve structure 120, described later, is inserted are collectively referred to as "other medical devices."

[0028] (Introducer sheath 100) As shown in Figures 1 and 2, the introducer sheath 100 comprises a sheath tube 110 and a valve structure 120.

[0029] (Sheath tube 110) The sheath tube 110 is connected to the housing 130 of the valve structure 120.

[0030] The sheath tube 110 has a tip portion 111 with a tip opening 111a and a base portion 113 located in the lumen 135 of the housing 130.

[0031] As shown in Figure 2, the proximal end 113 of the sheath tube 110 is positioned towards the tip of the port 139 provided in the housing 130. The proximal end 113 of the sheath tube 110 is provided with a proximal opening 113a that communicates with the lumen 135 of the housing 130.

[0032] The sheath tube 110 can be made of a hollow tubular member having a lumen 115 that extends continuously between the tip opening 111a and the base opening 113a.

[0033] The sheath tube 110 is configured to allow other medical devices 300 (see Figure 5) inserted into the housing 130 to be inserted into the lumen 115 of the sheath tube 110. The sheath tube 110 can be positioned so that other medical devices 300 inserted into the lumen 115 protrude toward the tip through the tip opening 111a of the sheath tube 110.

[0034] The sheath tube 110 can be made of, for example, a resin material known in the field of introducers. Examples of materials that can be used to make up the sheath tube 110 include polyolefins (e.g., polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or mixtures of two or more of these), polyolefin elastomers, crosslinked polyolefins, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesins (e.g., polytetrafluoroethylene, tetrafluoroethylene-ethylene copolymer, etc.), polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide, polyetheretherketone, and other polymer materials or mixtures thereof.

[0035] (Valve structure 120) The valve structure 120 can be used in medical devices inserted into blood vessels. As described above, this embodiment describes an example in which the valve structure 120 is used in an introducer sheath 100. However, the valve structure 120 can also be applied to other medical devices (for example, catheter devices and various treatment devices that are inserted into blood vessels during use).

[0036] As shown in Figures 1 to 5, the valve structure 120 includes a housing 130 having a lumen 135 and a housing portion 137 communicating with the lumen 135, and a valve body 140 positioned in the lumen 135 of the housing 130 and having an insertion portion 145 through which other medical instruments 300 (see Figure 5) can be inserted.

[0037] As shown in Figure 2, the entire valve body 140 is positioned within the lumen 135 of the housing 130 when no other medical device 300 is inserted through the insertion portion 145 of the valve body 140.

[0038] As shown in Figure 5, the housing 130 includes a wall structure (a wall-like portion constituting the skeletal portion 136) having a housing portion 137 that accommodates a part of the valve body 140 when another medical instrument 300 is inserted through the insertion portion 145 of the valve body 140, causing the valve body 140 to deform outward in a vertical direction perpendicular to the thickness direction of the valve body (a direction parallel to the axial direction of the introducer sheath 100) from the axial center of the valve body 140. When another medical instrument 300 is inserted through the insertion portion 145 of the valve body 140, the valve body 140 deforms in accordance with the change in volume of the insertion portion 145, causing a part of the valve body 140 to protrude outside the housing 130.

[0039] The valve body 140 is preferably made of a material that can be flexibly deformed in response to the volume change of the insertion portion 145 as described above. Examples of materials that can be used to make up the valve body 140 include silicone rubber, fluororubber, isoprene rubber, styrene elastomer, and the like.

[0040] Furthermore, it is preferable that the valve body 140 is impermeable to liquids (impermeable to blood) so as to prevent blood that has flowed into the lumen 135 of the housing 130 via the sheath tube 110 from passing through the inside of the valve body 140. To provide the above-mentioned impermeability to liquids, the valve body 140 can be coated with a predetermined coating material, for example, or the valve body 140 can be constructed from a material that is impermeable to liquids.

[0041] The insertion portion 145 of the valve body 140 is formed between the tip portion 141 and the base portion 143 of the valve body 140. The insertion portion 145 can be made up of, for example, a small hole penetrating in the thickness direction of the valve body 140 or a slit extending along the thickness direction of the valve body 140. In this embodiment, as shown in Figure 4, the insertion portion 145 is made up of a cross-cut slit cut in the thickness direction of the valve body 140. However, the insertion portion 145 is not particularly limited as long as it allows another medical instrument 300 inserted into the lumen 135 of the housing 130 to be inserted from the base end to the tip end of the valve body 140.

[0042] As shown in Figure 4, in this embodiment, the valve body 140 is provided with four insertion parts 145. In this example, an insertion part 145 that allows insertion of other larger diameter medical instruments is formed near the center of the valve body 140, and three insertion parts 145 that allow insertion of other relatively smaller diameter medical instruments are arranged at equal intervals around it. The specific configuration of the insertion parts 145 is not limited as long as one or more are provided on the valve body 140. There are also no particular restrictions on the number or layout of insertion parts 145 provided on a single valve body 140.

[0043] The valve body 140 can be fixed to a predetermined position on the housing 130. For example, the valve body 140 can be fixed to the housing 130 by a portion of its tip surface 141a (a portion excluding the position where the insertion portion 145 is formed, indicated by reference numeral 138a in Figure 2). For example, the valve body 140 can be fixed to the housing 130 by a portion of its base end surface 143a (a portion excluding the position where the insertion portion 145 is formed, indicated by reference numeral 138b in Figure 2).

[0044] There are no particular restrictions on the position in which the valve body 140 is fixed to the housing 130. For example, a part of the outer circumference 144 of the valve body 140 may be fixed to the skeletal portion 136 of the housing 130 (see Figure 3).

[0045] As shown in Figures 2, 3, and 5, the housing portion 137 of the housing 130 can be configured as an opening 137A that connects the inner cavity 135 of the housing 130 with the outside of the housing 130.

[0046] As shown in Figure 3, in this embodiment, the housing 130 includes a skeletal portion 136 formed in a predetermined pattern (for example, a grid pattern or a mesh pattern) on the wall portion that partitions the inner cavity 135 of the housing 130, and an opening 137A formed on the inside of the skeletal portion 136.

[0047] The pattern of the skeletal part 136 can adopt various shapes, as will be explained in the various modifications described later (see Figures 10 to 13), but in this embodiment, the skeletal part 136 has the shapes of multiple hexagons and multiple pentagons.

[0048] The housing 130 can be made of a member that can deform together with the valve body 140 when the valve body 140 expands and is housed in the housing 137 (see Figure 5) (for example, an elastically deformable member).

[0049] The components constituting the housing 130 can be those widely used in medical devices. For example, polyamide, polycarbonate, polyacetal, polyetheretherketone can be used as resin materials, and stainless steel, titanium and titanium alloys, nitinol, etc. can be used as metal materials. In this embodiment, since the skeletal portion 136 and the opening 137A are formed in the wall portion of the housing 130, the amount of material constituting the wall portion of the housing 130 is reduced, making the housing 130 even more easily deformable.

[0050] As shown in Figures 2 and 5, the proximal end 133 of the housing 130 is provided with a proximal opening 133a that allows other medical instruments 300 to be inserted into the lumen 135 of the housing 130.

[0051] As shown in Figures 1 and 2, the housing 130 is provided with a port 139. The port 139 can be used to supply priming fluid into the lumen 115 of the sheath tube 110 via the lumen 135, or to supply heparin or other substances for intravascular administration.

[0052] As shown in Figure 1, one end of a predetermined tube 180 can be connected to port 139. A three-way stopcock 190 can be connected to the other end of tube 180.

[0053] (Dilator 200) As shown in Figure 1, the dilator 200 includes a dilator body 210 that can be inserted into the lumen 115 of the sheath tube 110 of the introducer sheath 100, and a dilator hub 220 fixed to the base end of the dilator body 210.

[0054] The dilator 200 can be used to prevent the sheath tube 110 from kinking when inserting it into a blood vessel, or to widen the diameter of the puncture site (perforation) formed in the blood vessel wall.

[0055] Next, the effects of the valve structure 120 will be explained.

[0056] There are no particular restrictions on the procedure for using the introducer 10 (the procedure for inserting other medical devices 300 into a blood vessel via the sheath tube 110), nor on the specific types, product specifications, or number of other medical devices.

[0057] As shown in Figure 2, when no other medical device 300 is inserted through the insertion portion 145 of the valve body 140, the valve structure 120 maintains the insertion portion 145 closed by a force (e.g., elastic force) that maintains the shape of the valve body 140 itself. Therefore, the valve body 140 can exert its sealing properties, and even if blood flows into the lumen 135 of the housing 130 through the lumen 115 of the sheath tube 110, it is possible to prevent the blood from leaking out from the proximal end of the housing 130.

[0058] When a surgeon or other operator performs a procedure using another medical instrument 300, they insert the other medical instrument 300 into the insertion portion 145 of the valve body 140, as shown in Figure 5. The valve body 140 flexibly expands to widen its outer diameter as the volume of the insertion portion 145 increases when the other medical instrument 300 is inserted into it, as shown in Figure 5. Therefore, even when inserting multiple other medical instruments into the insertion portion 145, or when inserting a medical instrument with a relatively large outer diameter into the insertion portion 145, it is possible to prevent an increase in insertion resistance. As a result, surgeons and other operators can smoothly proceed with the task of inserting other medical instruments into the insertion portion 145.

[0059] In particular, in the valve structure 120 according to this embodiment, when the valve body 140 expands as described above, a portion of the outer circumference 144 of the valve body 140 can be accommodated by the housing portion 137 (opening 137A) provided in the housing 130. Therefore, the valve structure 120 can allow the expansion of the valve body 140 by the housing portion 137. As a result, other medical instruments 300 can be inserted more smoothly into the insertion portion 145 of the valve body 140.

[0060] Furthermore, in the valve structure 120 according to this embodiment, since the housing 130 itself is configured to be elastically deformable, when the valve body 140 expands as described above, the housing 130 can also expand along with the expansion of the valve body 140. As a result, the operator can insert other medical instruments 300 into the insertion portion 145 of the valve body 140 more smoothly.

[0061] As shown in Figure 5, the valve body 140 flexibly deforms to conform to the shape of the outer surface of the other medical device 300 when the other medical device 300 is inserted through the insertion portion 145. The valve body 140 presses its inner surface facing the insertion portion 145 against the outer surface of the other medical device 300 so that it is in close contact with it. As a result, the valve body 140 can seal the space between itself and the other medical device 300. The valve body 140 can suitably maintain a seal between itself and the other medical device 300 while the other medical device 300 is inserted through the insertion portion 145.

[0062] As described above, the valve structure 120 according to this embodiment is a valve structure used in a medical device (for example, an introducer sheath 100) inserted into a blood vessel, and comprises a housing 130 having a lumen 135 and a housing portion 137 communicating with the lumen 135, and a valve body 140 disposed in the lumen 135 of the housing 130 and having an insertion portion 145 through which another medical device 300 can be inserted, wherein the housing 130 includes a wall structure having a housing portion 137 that accommodates a part of the valve body 140 when another medical device 300 is inserted through the insertion portion 145 of the valve body 140 and the valve body 140 deforms outward in a vertical direction perpendicular to the thickness direction of the valve body 140 from the axial center of the valve body 140.

[0063] The valve structure 120 configured as described above can seal the space between the valve body 140 and the other medical device 300 as the other medical device 300 is inserted into the insertion portion 145 of the valve body 140. Therefore, according to this embodiment, it is possible to provide a valve structure 120 and an introducer sheath 100 that can exhibit high sealing performance and have excellent operability.

[0064] <Variation> Next, we will describe various modifications of the embodiments described above. In the description of each modification, we will omit redundant explanations of components and other elements that have already been described.

[0065] Figure 6 shows the valve structure 120A according to modified example 1.

[0066] In the valve structure 120A according to Modification 1, there is a film-like sealing portion 150 that is arranged to cover at least a part of the surface of the valve body 140.

[0067] As shown in Figure 6, the sealing portion 150 can be positioned, for example, to cover the outer circumference 144 of the valve body 140. The valve structure 120 can improve the sealing performance between the outer circumference 144 of the valve body 140 and the housing 130 by having the outer circumference 144 of the valve body 140 covered by the sealing portion 150.

[0068] When the sealing portion 150 is positioned to cover the outer circumference 144 of the valve body 140, it is preferable that the sealing portion 150 be made of a relatively flexible material so as not to hinder the expansion of the valve body 140 (see Figure 5). Furthermore, it is preferable that the sealing portion 150 be made of a material that is impermeable to liquids (impermeable to blood) in order to exhibit suitable sealing performance. It is also preferable that it be made of a material with excellent sliding properties to allow smooth insertion of medical devices. As materials for constituting the sealing portion 150, for example, polymer materials such as polyolefins (e.g., polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or mixtures of two or more thereof), polyolefin elastomers, crosslinked polyolefins, polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, fluororesins (e.g., polytetrafluoroethylene, tetrafluoroethylene-ethylene copolymer, etc.) or mixtures thereof can be used. Furthermore, the sealing portion 150 can be made of a film with a thickness of, for example, 0.1 to 0.5 mm.

[0069] Figure 7 shows the valve structure 120B according to modified example 2.

[0070] The valve structure 120B according to the second modification includes a rigid cover 160 that covers the housing 130 from the outside. The rigid cover 160 can be made of, for example, a resin material or a metal material that is harder than the housing 130.

[0071] The rigid cover 160 contacts the valve body 140 when the valve body 140 expands, and a portion of the outer circumference 144 of the valve body 140 is housed in the housing portion 137 (opening 137A) of the housing 130, and when it attempts to protrude further outward from the housing portion 137, thereby limiting the expansion of the valve body 140. Because the expansion of the valve body 140 is limited by the rigid cover 160, it becomes possible to apply a greater compressive force toward the insertion portion 145 (central axis) side. Therefore, the valve structure 120B can further improve the sealing performance of the insertion portion 145.

[0072] Figure 9 shows the valve structure 120C according to modified example 3.

[0073] In the valve structure 120C according to modified example 3, the housing portion 137 formed in the housing 130 is composed of a recess 137B instead of an opening 137A.

[0074] The recess 137B is a recess that is recessed outward in the direction perpendicular to the axial direction when viewed from the axial center side (insertion portion 145 side) of the valve body 140.

[0075] Since the housing 130 has a housing portion 137 formed by a recess 137B, the rigidity of the housing 130 can be increased compared to the case where the housing 130 has an opening 137A composed of an open through hole. Therefore, when the valve body 140 expands (see Figure 5), the valve structure 120C can prevent the skeletal portion 136 of the housing 130 from deforming excessively in conjunction with the expansion of the valve body 140. As a result, the valve structure 120C can apply a greater compressive force toward the insertion portion 145 (central axis) when the valve body 140 expands. Therefore, the valve structure 120C can further improve the sealing performance of the insertion portion 145.

[0076] Figure 9 shows the valve structure 120D according to modified example 4.

[0077] The valve structure 120D according to Modification 4 includes a sealing portion 150A positioned in the insertion portion 145. The sealing portion 150A is inserted through the insertion portion 145 and extends a predetermined length toward the tip and base ends of the valve body 140.

[0078] The valve structure 120D is equipped with a sealing portion 150A located in the insertion portion 145, thereby further improving the sealing performance in the insertion portion 145. When another medical device 300 is inserted into the insertion portion 145 (see Figure 5), the valve body 140 presses the sealing portion 150A located in the insertion portion 145 against the outer surface of the other medical device 300. This seals the space between the other medical device 300 and the sealing portion 150.

[0079] The sealing portion 150A is preferably made of a material that is impermeable to liquids (impermeable to blood), similar to the sealing portion 150 described in the modified example 1 above. Furthermore, in order to prevent the insertion resistance of other medical instruments 300 inserted into the insertion portion 145 from increasing when the sealing portion 150 is positioned in the insertion portion 145, the sealing portion 150 is preferably made of a material with low friction properties, such as Teflon.

[0080] <Example of Housing 130 structure> The housing used in the valve structure 120 is not particularly limited in terms of its specific shape or structure, as long as it has a housing portion 137 that can accommodate at least a part of the outer circumference 144 of the valve body 140 when the valve body 140 is expanded.

[0081] For example, as shown in Figure 10, the housing 130A can be configured to include rhomboid and triangular skeletal parts 136 and an opening 137A. The housing 130A configured in this way becomes more elastically deformable.

[0082] For example, as shown in Figure 11, the housing 130B may have a cut portion 136a (discontinuous portion) formed in a part of the skeletal portion 136. By having the cut portion 136a, the housing 130B becomes even more elastically deformable.

[0083] For example, as shown in Figure 12, the housing 130C can be configured to include a skeletal structure 136 formed in a square grid pattern and an opening 137A. A housing 130C configured in this way is less susceptible to elastic deformation compared to the housing 130A shown in Figure 10.

[0084] For example, as shown in Figure 13, the housing 130D can be configured to include a circular opening 137A and a frame-shaped skeletal portion 136 that covers the circular opening 137A. A housing 130D configured in this way is less prone to elastic deformation compared to the housing 130A shown in Figure 10.

[0085] Furthermore, each of the housings 130, 130A, 130B, 130C, and 130D described herein allows for arbitrary adjustment of the amount (insertion) of the outer circumference 144 of the valve body 140 when the valve body 140 expands, by adjusting the size of the housing portion 137 (opening 137A and recess 137B), the number of housing portions per unit area, etc.

[0086] Although the valve structure and introducer sheath according to the present invention have been described above through embodiments, the present invention is not limited to the configurations described and can be modified as appropriate based on the claims. [Explanation of Symbols]

[0087] 10. Introducer (Medical Device) 100 Introducer Sheath 110 Sheath tube 115 lumens 120 Valve structure 120A Valve Structure 120B Valve structure 120C Valve Structure 120D Valve Structure 130 Housing 130A Housing 130B Housing 130C Housing 130D Housing 133 Base of the housing 133a Base opening of the housing 135 Lumen of the housing 136 Skeletal part 136a Cut section 137 Containment Unit 137A opening 137B Recess 140 valve body 141 Tip of the valve body 143 Base of the valve body 144 Outer circumference of the valve body 145 Insertion part 150 sealing part 150A seal section 160 Hard Cover 200 dilators 300 Other medical devices

Claims

1. A valve structure used in medical devices inserted into blood vessels, A housing comprising a lumen and a housing portion communicating with the lumen, The housing has a valve body disposed within the lumen and having an insertion portion through which other medical instruments can be inserted, The valve structure comprises a wall structure having a housing portion that accommodates a part of the valve body when the valve body deforms due to the insertion portion of the valve body being inserted into the insertion portion of the valve body.

2. The valve structure according to claim 1, wherein the housing portion is an opening that connects the lumen to the outside of the housing.

3. The valve structure according to claim 1, wherein the housing portion is a recess that is recessed outward in the direction perpendicular to the axial direction when viewed from the axial center side of the valve body.

4. The valve structure according to claim 1, wherein the housing is made of a member that can deform together with the valve body when the valve body deforms.

5. The valve structure according to claim 1, further comprising a film-like sealing portion disposed to cover at least a portion of the surface of the valve body.

6. A valve structure according to any one of claims 1 to 5, An introducer sheath comprising a sheath tube connected to the housing at a position closer to the tip than the position where the valve body is located.

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