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 valve body 130 having a flexible porous member with an insertion portion 135 through which other medical instruments 300A, 300B can be inserted, a housing 140 made of a material harder than the valve body, and a film-like sealing portion 150 arranged to cover at least a part of the surface of the valve body. The valve body is positioned in the housing so as to divide the lumen 145 of the housing into a proximal region 145A located on the proximal side of the valve body and a distal region 145B located on the distal side of the valve body, and at least a part of the sealing portion is positioned on the inner circumferential surface of the valve body facing the insertion portion.

Description

Technical Field

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

Background Art

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

[0003] A valve body (check valve) is disposed in the housing to prevent various liquids (for example, 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 contractable 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 a liquid 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 cope with 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 valve body comprising a flexible porous member having an insertion portion formed therein through which other medical instruments can be inserted, A housing made of a material harder than the valve body, The valve body has a film-like sealing portion that is arranged to cover at least a part of the surface of the valve body, The valve body is positioned in the housing such that it divides the lumen of the housing into a proximal region located on the proximal side of the valve body and a distal region located on the distal side of the valve body. A valve structure wherein at least a portion of the sealing portion is arranged on the inner circumferential surface of the valve body facing the insertion portion.

[0012] (2) The sealing portion is composed of a tubular body having a lumen, The valve structure according to (1), wherein at least one of the base end and tip end of the sealing portion is fixed to the housing.

[0013] (3) The valve structure according to (1) or (2), wherein the valve body is positioned in the lumen of the housing with a predetermined gap between the outer surface of the valve body and the inner surface of the housing when the medical device is not inserted into the insertion portion.

[0014] (4) The valve structure according to any one of (1) to (3), further comprising a highly elastic member disposed on the outer circumferential surface side of the valve body, which has higher elasticity than the porous member.

[0015] (5) The seal part is arranged so as to cover the inner peripheral surface, base end surface, tip end surface, and outer peripheral surface of the valve body, and the valve structure according to any one of (1) to (4).

[0016] (6) A valve structure according to any one of (1) to (5), and a sheath tube connected to the housing at a position on the tip end side of the position where the valve body is arranged, and a sheath for an introducer. [Advantages of the Invention]

[0017] According to the present invention, it is possible to provide a valve structure and a sheath for an introducer 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 a sheath for an introducer 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 cross-sectional view taken along the line 3A - 3A shown in FIG. 2. [Figure 4] It is a partial cross-sectional view showing a valve structure of a sheath for an introducer according to an embodiment, and is a diagram showing a state when inserting another medical instrument into the valve structure. [Figure 5] It is a cross-sectional view taken along the line 5A - 5A shown in FIG. 4. [Figure 6] It is a perspective view for explaining the operation and effect of the valve structure, and is a diagram showing a state before inserting another medical instrument into the valve structure. [Figure 7] It is a perspective view for explaining the operation and effect of the valve structure, and is a diagram showing a state when inserting another medical instrument into the valve structure. [Figure 8] It is a partial cross-sectional view showing a valve structure according to Modification 1. [Figure 9]This is a partial cross-sectional view showing a valve structure relating to modified example 2. [Figure 10] This is a partial cross-sectional view showing a valve structure according to modified example 3. [Modes 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 7. 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 4 are partial cross-sectional views (partial cross-sectional views along the axial direction) of the valve structure 120 of the introducer sheath 100. Figures 3 and 5 are orthogonal cross-sectional views of the locations indicated by the arrows in Figures 2 and 4 (locations indicated by arrows 3A-3A and 5A-5A). Figures 6 and 7 are perspective views to explain the operation and effect of the valve structure 120.

[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 140 is located (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 (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 (up and down 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 130 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 140 of the valve structure 120.

[0030] The sheath tube 110 has a tip portion 111 with a tip opening 111a formed therein, and a base portion 113 positioned in the lumen 145 of the housing 140.

[0031] As shown in Figure 2, the proximal end 113 of the sheath tube 110 is positioned towards the tip of the port 148 provided in the housing 140. The proximal end 113 of the sheath tube 110 is provided with a proximal opening 113a that communicates with the lumen 145 of the housing 140.

[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 instruments 300A and 300B, which are inserted into the housing 140, to be inserted into the lumen 115 of the sheath tube 110. The sheath tube 110 can be positioned so that the other medical instruments 300A and 300B, which are 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 valve body 130 having a porous member with an insertion portion 135 through which other medical instruments 300A, 300B (see Figures 4 and 5) can be inserted, a housing 140 made of a material harder than the valve body 130, and a film-like sealing portion 150 arranged to cover at least a part of the surface of the valve body 130.

[0037] As shown in Figures 2 and 4, the valve body 130 is positioned in the housing 140 such that it divides the lumen 145 of the housing 140 into a proximal region 145A located on the proximal side of the valve body 130 and a distal region 145B located on the distal side of the valve body 130.

[0038] As shown in Figure 2, at least a portion of the sealing portion 150 is positioned on the inner circumferential surface of the valve body 130 that faces the insertion portion 135 of the valve body 130.

[0039] In this embodiment, the valve body 130 is made of a porous material. As the porous material constituting the valve body 130, for example, polyethylene, polyurethane, polyester, fluororesin (PTFE), etc., having a predetermined porosity can be used.

[0040] The insertion portion 135 of the valve body 130 is formed between the tip portion 131 and the base portion 133 of the valve body 130. The insertion portion 135 can be made up of, for example, a small hole penetrating in the thickness direction of the valve body 130 or a slit extending along the thickness direction of the valve body 130. However, the insertion portion 135 is not particularly limited as long as other medical instruments 300A and 300B inserted into the lumen 145 of the housing 140 can be inserted through the valve body 130 from the base end to the tip end.

[0041] The valve body 130 can be fixed to predetermined support parts 146a and 146b provided in the lumen 145 of the housing 140.

[0042] For example, the valve body 130 can be fixed to a first support portion 146a located on the base end side of the valve body 130, with a portion of its base end surface 133a (excluding the position where the insertion portion 135 is formed). Alternatively, the valve body 130 can be fixed to a second support portion 146b located on the tip end side of the valve body 130, with a portion of its tip end surface 131a (excluding the position where the insertion portion 135 is formed). Note that each support portion 146a and 146b may be formed from a part of the housing 140 (for example, a part of the inner wall of the housing 140).

[0043] The sealing portion 150 can be made of a material that is impermeable to liquids (impermeable to blood), for example, processed into a film. Examples of materials that can be used to make up the sealing portion 150 include polyethylene, polyvinyl alcohol, polyolefin elastomer, ethylene / vinyl acetate copolymer, silicone, and fluororesin. Furthermore, the sealing portion 150 can be made of a film with a thickness of, for example, 0.02 mm to 0.3 mm.

[0044] The sealing portion 150 is partially inserted into the insertion portion 135 of the valve body 130. As shown in Figures 2, 3, and 6, when no other medical devices 300A and 300B are inserted into the valve body 130, the portion of the sealing portion 150 positioned in the insertion portion 135 is pressed against the inner circumferential surface of the valve body 130 by the valve body 130. In this state, the valve structure 120 can prevent blood from passing through the sealing portion 150 and moving to the proximal end region 145A of the housing 140, even when blood flows into the tip region 145B of the lumen 145 of the housing 140. Therefore, the valve structure 120 can effectively prevent blood from leaking out from the proximal end side of the housing 140 through the lumen 145 of the housing 140, even when no other medical devices 300A and 300B are inserted into the insertion portion 135 of the valve body 130.

[0045] As shown in Figures 5 and 6, the sealing portion 150 can be made up of a tubular body having a lumen.

[0046] At least one of the base end portion 153 and the tip end portion 151 of the sealing portion 150 can be fixed to the housing 140.

[0047] In this embodiment, as shown in Figure 2, the base end portion 153 of the seal portion 150 is fixed to the housing 140 by being sandwiched between a cap member 170 attached to the base end of the housing 140 and a first support portion 146a. The tip portion 151 of the seal portion 150 is fixed to the housing 140 by being sandwiched between a stepped portion provided on the inner wall of the housing 140 and a second support portion 146b.

[0048] As shown in Figure 2, the valve body 130 is positioned in the lumen 145 of the housing 140 with a predetermined gap g between the outer circumferential surface 130b of the valve body 130 and the inner circumferential surface 140a of the housing 140, when no other medical instruments 300A and 300B are inserted into the insertion portion 135.

[0049] As shown in Figure 2, the housing 140 is provided with a port 148. The port 148 can be used to supply priming fluid into the lumen 115 of the sheath tube 110 via the lumen 145, or to supply heparin or other substances for intravascular administration.

[0050] As shown in Figure 1, one end of a predetermined tube 180 can be connected to port 148. A three-way stopcock 190 can be connected to the other end of tube 180.

[0051] A strain relief 160 can be attached near the tip of the housing 140. The strain relief 160 prevents kinks, bends, and other damage from occurring in the sheath tube 110.

[0052] A cap member 170 can be attached to the base end of the housing 140 to allow the insertion of other medical instruments 300A and 300B into the housing 140. The cap member 170 may have an opening that narrows in diameter towards the tip.

[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] The following explanation describes some procedure examples for inserting other medical devices 300A and 300B into a blood vessel via the sheath tube 110, while a portion of the tip 111 of the sheath tube 110 is inserted (placed) inside the blood vessel. There are no particular restrictions on the specific type, product specifications, or number of other medical devices.

[0057] When the surgeon or other personnel perform procedures using other medical instruments 300A and 300B, they insert the other medical instruments 300A and 300B into the insertion portion 135 of the valve body 130, as shown in Figures 4, 5, and 7. Since the valve body 130 is made of a porous material, when other medical instruments 300A and 300B are inserted into the insertion portion 135, the valve body 130 itself expands to widen its outer diameter. Therefore, even when inserting multiple other medical instruments 300A and 300B into the insertion portion 135 simultaneously, or when inserting other medical instruments with a relatively large outer diameter, the insertion process can be carried out smoothly.

[0058] In this embodiment, since the sealing portion 150 is composed of a tubular body with a lumen, when inserting other medical instruments 300A and 300B into the insertion portion 135 of the valve body 130 as described above, they can be inserted into the lumen of the sealing portion 150 located in the insertion portion 135 along with the insertion portion 135. This allows other medical instruments 300A and 300B to be smoothly inserted into the sealing portion 150 as well.

[0059] Furthermore, in this embodiment, since a gap g is formed in the lumen 145 of the housing 140, the gap g allows the valve body 130 to expand within the lumen 145. Therefore, other medical instruments 300A and 300B can be inserted more smoothly into the insertion portion 135 of the valve body 130.

[0060] Furthermore, since the housing 140 is made of a harder material than the valve body 130, when the valve body 130 expands to a certain extent, the outer circumferential surface 130b of the valve body 130 comes into contact with the inner circumferential surface 140a of the housing 140. This prevents the valve body 130 from expanding indefinitely, and ensures that the valve body 130 provides a seal.

[0061] As shown in Figures 4, 5, and 7, the valve body 130 flexibly deforms to conform to the shape of the outer circumferential surface of the other medical devices 300A and 300B when they are inserted through the insertion portion 135. In this deformed state, the valve body 130 presses the sealing portion 150, which is positioned in the insertion portion 135, against the outer circumferential surface of the other medical devices 300A and 300B. By pressing the sealing portion 150 against the outer circumferential surface of the other medical devices 300A and 300B as described above, the valve body 130 can seal the space between the other medical devices 300A and 300B and the sealing portion 150. The valve body 130 can suitably maintain the sealing performance between the other medical devices 300A and 300B and the sealing portion 150 while they are inserted through the insertion portion 135. This prevents blood from moving to the proximal region 145A even when blood flows into the tip region 145B of the lumen 145 of the housing 140. This prevents blood that has flowed into the lumen 145 of the housing 140 from leaking out from the proximal side of the housing 140.

[0062] As described above, the valve structure 120 according to this embodiment is a valve structure used in a medical device inserted into a blood vessel (for example, an introducer sheath 100), and comprises a valve body 130 having a flexible porous member with an insertion portion 135 through which other medical devices 300A and 300B can be inserted, a housing 140 made of a material harder than the valve body 130, and a film-like sealing portion 150 arranged to cover at least a part of the surface of the valve body 130. The valve body 130 is arranged in the housing 140 so as to divide the lumen 145 of the housing 140 into a proximal region 145A located on the proximal side of the valve body 130 and a distal region 145B located on the distal side of the valve body 130, and at least a part of the sealing portion 150 is arranged on the inner circumferential surface of the valve body 130 facing the insertion portion 135.

[0063] According to this embodiment configured as described above, it is possible to provide a valve structure 120 and a sheath tube 110 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 8 shows the valve structure 120A according to modified example 1.

[0066] In the valve structure 120A according to Modification 1, the sealing portion 150 is arranged to cover the inner circumferential surface, base end surface 133a, tip end surface 131a, and outer circumferential surface 130b of the valve body 130 that faces the insertion portion 135.

[0067] As described above, the valve structure 120A is provided with a two-layer sealing member having an inner layer made of a porous material valve body 130 and an outer layer made of a sealing portion 150 that covers the inner layer, with the sealing portion 150 positioned to cover the entire surface of the valve body 130.

[0068] As described above, the valve structure 120A, when no other medical devices 300A and 300B are inserted into the insertion portion 135 of the valve body 130, can prevent blood from moving towards the proximal region 145A of the lumen 145 of the housing 140 by the sealing portion 150 positioned to cover the valve body 130. Furthermore, even when other medical devices 300A and 300B are inserted into the insertion portion 135 of the valve body 130, the sealing portion 150 and the valve body 130 can still provide optimal sealing performance.

[0069] Furthermore, when adopting the configuration of Modified Example 1, it is preferable not to provide a gap g between the portion of the seal 150 that covers the outer circumferential surface 130b of the valve body 130 and the inner circumferential surface 140a of the housing 140. This is because if a gap g is provided, when no other medical instruments 300A and 300B are inserted into the insertion portion 135 of the valve body 130, there is a possibility that blood will move through the gap g towards the proximal end region 145A of the lumen 145 of the housing 140.

[0070] Figure 9 shows the valve structure 120B according to modified example 2.

[0071] In the valve structure 120B according to the modified example 2, a highly elastic member 138 is further provided, which is positioned on the outer peripheral surface 130b side of the porous member constituting the valve body 130 and has higher elasticity than the porous member.

[0072] Since the valve structure 120 is equipped with a highly elastic member 138, when other medical instruments 300A and 300B are inserted into the insertion portion 135 of the valve body 130 and the valve body 130 expands (see Figures 4, 5, and 7), a high elastic force can be applied from the outer circumferential surface 130b side of the valve body 130. As a result, the valve body 130 can apply an elastic force toward the inner circumferential surface side to the other medical instruments 300A and 300B inserted into the insertion portion 135. This allows the valve body 130 to be pressed against the other medical instruments 300A and 300B in a tightening manner, further improving the sealing performance between the seal portion 150 and the other medical instruments 300A and 300B.

[0073] The highly elastic member 138 can be made of, for example, silicone, polyurethane, polyethylene, synthetic rubber, hydrocarbon thermoplastic resin, etc.

[0074] In this modified example, as shown in Figure 9, a gap g can be provided between the high-elasticity member 138 and the inner circumferential surface 140a of the housing 140 to allow the high-elasticity member 138 to expand.

[0075] Figure 10 shows the valve structure 120C according to modified example 3. In the valve structure 120C according to the modified example 3, the base end 153 of the seal portion 150 is fixed to the housing 140, but the tip end 151 is not fixed to the housing 140.

[0076] In the valve structure 120C configured as described above, as shown by arrow f in Figure 10, when no other medical devices 300A and 300B are inserted into the insertion portion 135 of the valve body 130, if blood flows into the lumen 145 of the housing 140, the blood moves through the valve body 130, which is made of a porous material, to the proximal end region 145A of the lumen 145 of the housing 140. However, in the lumen 145 of the housing 140, the area on the proximal end side of the position where the valve body 130 is located is closed off near the proximal end 153 of the seal portion 150. Therefore, even if blood flows into the lumen 145 of the housing 140, it moves further proximal than the proximal end 153 of the seal portion 150, preventing blood from leaking out of the housing 140.

[0077] Furthermore, in the valve structure 120C according to the modified example 3, it is possible to effectively seal the space between the other medical instruments 300A and 300B and the sealing portion 150 when the other medical instruments 300A and 300B are inserted through the insertion portion 135 of the valve body 130, just as in the embodiment described above.

[0078] 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]

[0079] 10. Introducer (Medical Device) 100 Introducer Sheath 110 Sheath tube 115 lumens 120 Valve structure 120A Valve Structure 120B Valve structure 120C Valve Structure 130 valve body 130b Outer surface of the valve body 131 Tip of the valve body 131a Tip surface of the valve body 133 Base of the valve body 133a Base end surface of the valve body 135 Insertion part 138 High-elasticity material 140 Housing 140a Inner surface of the housing 145 Lumen 145A Proximal region 145B Tip area 150 sealing part 151 Tip of the sealing part 153 Base end of seal portion 170 Cap component 200 dilators 300A Other medical devices 300B Other medical devices g gap

Claims

1. A valve structure used in medical devices inserted into blood vessels, A valve body comprising a flexible porous member having an insertion portion formed therein through which other medical instruments can be inserted, A housing made of a material harder than the valve body, The valve body has a film-like sealing portion that is arranged to cover at least a part of the surface of the valve body, The valve body is positioned in the housing such that it divides the lumen of the housing into a proximal region located on the proximal side of the valve body and a distal region located on the distal side of the valve body. A valve structure wherein at least a portion of the sealing portion is arranged on the inner circumferential surface of the valve body facing the insertion portion.

2. The sealing portion is composed of a tubular body having a lumen, The valve structure according to claim 1, wherein at least one of the base end and tip end of the sealing portion is fixed to the housing.

3. The valve structure according to claim 1, wherein the valve body is positioned in the lumen of the housing with a predetermined gap between the outer surface of the valve body and the inner surface of the housing when the medical device is not inserted into the insertion portion.

4. The valve structure according to claim 1, further comprising a highly elastic member disposed on the outer circumferential surface side of the valve body, the highly elastic member having higher elasticity than the porous member.

5. The valve structure according to claim 1, wherein the sealing portion is arranged to cover the inner circumferential surface, base end surface, tip surface, and outer circumferential 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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