Introducer sheath

Abstract

To provide an introducer sheath capable of exhibiting high sealability and having excellent operability even when a diameter of a sheath part is increased.SOLUTION: A valve body 110 disposed in a housing 160 has a valve body main body 120 made of a resin material, a hole 130 penetrating the valve body main body in a thickness direction, and a plurality of convex portions 140 protruding in an arc shape toward a center side of the valve body main body and forming a hole on the center side of the valve body main body, and each of the plurality of convex portions is configured to transition to a closed state in which the hole is closed by the valve body main body being compressed and close a space between one or more medical instruments 500 inserted into the hole and the valve body main body.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present invention relates to an introducer sheath. [Background technology]

[0002] Introducers are used as medical devices for forming access paths into biological lumens such as blood vessels in procedures using catheters. A typical introducer includes an introducer sheath and a dilator. The introducer sheath includes a sheath portion (sheath tube) having an inner lumen into which a guidewire or catheter device (hereinafter collectively referred to as "medical device") can be inserted, and a housing (hub) connected to the sheath portion.

[0003] The housing is provided with a valve body (check valve) that prevents various liquids (e.g., blood, contrast medium, saline solution, etc.) from leaking out of the introducer sheath through the housing when the medical device is inserted into the sheath portion.

[0004] The introducer sheath described in Patent Document 1 utilizes an expandable and contractible balloon disposed within the housing as a valve mechanism. With a medical device inserted into the housing and sheath, the surgeon can expand the balloon to close the space between the medical device and the balloon. This allows a transition to a sealed state (closed state) that prevents fluid from leaking out of the introducer sheath through the housing.

[0005] Furthermore, the introducer sheath described in Patent Document 1 utilizes a balloon as a valve mechanism, and by adjusting the amount of expansion of the balloon, it is possible to accommodate the following procedures.

[0006] In procedures for inserting multiple medical instruments (catheters) into blood vessels, an introducer sheath may be inserted into a relatively large-diameter blood vessel running through the lower limb. The introducer sheath has a large-diameter sheath, making it possible to accommodate procedures using multiple medical instruments simultaneously. Furthermore, to enable access to multiple side holes in a biological organ, procedures may be performed in which multiple guidewires, contrast catheters, tip-variable catheters, etc. are simultaneously inserted into a large-diameter sheath. The introducer sheath of Patent Document 1 can occlude the space between each medical instrument and the balloon by adjusting the inflation amount of the balloon, even when multiple medical instruments are inserted into the sheath simultaneously. Therefore, it is believed that high sealing performance can be maintained even when the sheath has a large diameter. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] Patent Publication No. 2022-27860 Summary of the Invention [Problem to be solved by the invention]

[0008] However, because the introducer sheath in Patent Document 1 uses a balloon as a valve mechanism, when blocking 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 blocked state, the balloon must be deflated by operating the fluid supply device each time. Therefore, the procedure using the introducer sheath is complicated.

[0009] The present invention has been made in consideration of the above-mentioned problems, and aims to provide a sheath for an introducer that can exhibit high sealing performance even when the sheath portion has a large diameter and has excellent operability. [Means for solving the problem]

[0010] The present invention can be achieved by any one of the following means (1) to (7).

[0011] (1) a valve body through which one or more medical instruments to be inserted into a living body are inserted; a housing in which the valve body is held; a sheath portion having an inner lumen into which the one or more medical instruments can be inserted, The valve body is a valve body made of a resin material; a slit and / or hole penetrating the valve body in a thickness direction; a plurality of convex portions that protrude in an arc shape toward the center of the valve body main body and form the slits and / or the holes on the center side of the valve body main body, an introducer sheath configured such that each of the plurality of convex portions transitions to a closed state in which the slits and / or the holes are closed when the valve body is compressed, thereby closing the space between the one or more medical instruments inserted through the slits and / or the holes and the valve body.

[0012] (2) The sheath for introducer according to (1), wherein the valve body main body has each of the plurality of convex portions integrally formed from the resin material.

[0013] (3) The sheath for introducer according to (1) or (2), further comprising a pressing portion disposed in the housing, which compresses the valve body in the radial direction as the valve body moves vertically, thereby transitioning each of the plurality of convex portions to the closed state.

[0014] (4) The sheath for introducer described in (3), wherein the pressing portion is positioned closer to the base end of the housing than the valve body main body and has a cap member that applies the pressing force to the valve body main body as it is screwed into the housing.

[0015] (5) The sheath for introducer according to (1), wherein the valve body main body is composed of a plurality of divided pieces made of the resin material that form the plurality of convex portions, respectively.

[0016] (6) a biasing member disposed so as to surround the valve body and applying a compressive force to the valve body in a radial direction; The sheath for introducer described in (5), wherein the biasing member is configured to allow the one or more medical instruments to be inserted into the slits and / or the holes when the compressive force is applied to the valve body, and to maintain the compressive force applied so that the space between the one or more medical instruments and the valve body is closed when the one or more medical instruments are inserted into the slits and / or the holes.

[0017] (7) The sheath for introducer according to any one of (1) to (6), wherein each of the plurality of convex portions is arranged on the same plane. [Effects of the Invention]

[0018] In the introducer sheath according to the present invention, when the valve body is compressed, the multiple convex portions formed on the valve body transition to a closed state in which they close the slits and / or holes. When the multiple convex portions transition to the closed state, each of the multiple convex portions contacts the outer surface of one or more medical instruments inserted into the valve body, thereby closing the space between the valve body and the one or more medical instruments. Therefore, even when the sheath portion is configured with a large diameter, it is possible to effectively prevent fluids such as blood from leaking out of the introducer sheath through the gap between the valve body and the one or more medical instruments. Furthermore, since the closed state and the non-closed state can be easily switched by applying a compressive force to the valve body and then releasing the compressive force applied to the valve body, the procedure using the introducer sheath does not become complicated. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 2 is a diagram showing an introducer according to the first embodiment. [Figure 2] FIG. 10 is a cross-sectional view of a housing provided in the introducer sheath. [Figure 3] FIG. 2 is a perspective view showing a housing and a valve body. [Figure 4] FIG. 4 is a plan view showing the valve body in an unblocked state. [Figure 5] FIG. 10 is a plan view showing a state in which one or more medical instruments are inserted into the valve body in the non-occluded state. [Figure 6] FIG. 4 is a plan view showing the valve body in a closed state. [Figure 7] FIG. 4 is a plan view showing a modified example of the valve body of the first embodiment. [Figure 8] FIG. 4 is a plan view showing a modified example of the valve body of the first embodiment. [Figure 9] FIG. 10 is a perspective view showing a valve body and a biasing member according to a second embodiment. [Figure 10] FIG. 4 is a plan view showing the valve body in an unblocked state. [Figure 11] FIG. 4 is a plan view showing the valve body in a closed state. [Figure 12] FIG. 10 is a plan view showing a valve body according to a modified example of the second embodiment. [Figure 13] FIG. 10 is a plan view showing a valve body according to a modified example of the second embodiment. [Figure 14] FIG. 10 is a plan view showing a valve body according to a modified example of the second embodiment. [Figure 15] FIG. 10 is a plan view showing a valve body according to a modified example of the second embodiment. [Figure 16] FIG. 10 is a plan view showing a valve body according to a modified example of the second embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0020] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. The following description does not limit the technical scope or meaning of terms described in the claims. Furthermore, the dimensional proportions in the drawings are exaggerated for the convenience of explanation and may differ from the actual proportions.

[0021] First Embodiment An introducer sheath 100 according to this embodiment will be described with reference to Figures 1 to 6. In this specification, the embodiment will be described using an introducer 10 having the introducer sheath 100 and a dilator 300 as components.

[0022] Fig. 1 is a diagram showing the introducer 10. Fig. 2 is a partial cross-sectional view (partial cross-sectional view along the axial direction) of the introducer sheath 100 near the housing 160. Fig. 3 is a perspective view schematically showing the housing 160 and the valve body 110. Figs. 4 to 6 are diagrams for explaining the action and effect of the valve body 110, and are plan views seen from the direction of arrow 4A shown in Fig. 3.

[0023] In this specification, the direction in which the sheath portion 190 of the introducer sheath 100 extends (the direction indicated by arrows X1-X2 in the figure) is defined as the axial direction. The side of the introducer sheath 100 on which the housing 160 is disposed (the side indicated by arrow X1) is defined as the "proximal side," and a certain range including the end portion located on the proximal side is defined as the "proximal end." Furthermore, the side of the introducer sheath 100 opposite the proximal side and inserted into the living body (the side indicated by arrow X2) is defined as the "distal side," and a certain range including the end portion located on the distal side is defined as the "distal end." Furthermore, the clockwise or counterclockwise direction around the central axis (axial center) c1 of the sheath portion 190 is defined as the "circumferential direction."

[0024] (Introducer 10) As shown in FIG. 1, the introducer 10 includes an introducer sheath 100 and a dilator 300.

[0025] The introducer sheath 100 can be used to introduce the dilator body 310 of the dilator 300 or one or more medical instruments (e.g., various catheter devices, guide wires, etc.) into a biological lumen such as a blood vessel through the lumen 195 of the sheath portion 190 (see Figure 2).

[0026] (Introducer Sheath 100) The introducer sheath 100, as generally described with reference to Figures 1 to 3, comprises a valve body 110 through which one or more medical instruments 500 (hereinafter simply referred to as "medical instruments 500") to be inserted into a living body are inserted, a housing 160 in which the valve body 110 is held, and a sheath portion 190 having an inner cavity 195 through which the medical instruments 500 can be inserted.

[0027] 1 and 2, the housing 160 is disposed near the proximal end 123 of the introducer sheath 100. A cap member 180 is disposed on the proximal end side of the housing 160.

[0028] 2, the proximal end 123 of the sheath portion 190 is connected to the housing 160 so that the lumen 195 of the sheath portion 190 communicates with the internal space 161 of the housing 160. The valve body 110 is held in the internal space 161 of the housing 160.

[0029] The medical device 500 to be introduced into the living body using the introducer sheath 100 is inserted into the inner cavity 195 of the sheath portion 190 through the through hole 183 formed in the cap member 180, the hole 130 in the valve body 110, and the internal space 161 of the housing 160.

[0030] 1, a distal end opening 191a communicating with the lumen 195 is formed in the distal end portion 191 of the sheath portion 190. The medical instrument 500 inserted into the lumen 195 of the sheath portion 190 can protrude toward the distal end of the sheath portion 190 through the distal end opening 191a of the sheath portion 190. In addition, in a state in which the dilator 300 is assembled (connected) to the introducer sheath 100, a certain range of the distal end of the dilator main body 310 can protrude from the lumen 195 of the sheath portion 190.

[0031] The valve body 110 arranged in the internal space 161 of the housing 160 functions as a check valve that prevents liquids such as blood from leaking from the base end side of the housing 160 (the base end side of the introducer sheath 100) to the outside when a medical instrument 500 or a dilator 300 is inserted into the lumen 195.

[0032] As shown in Figures 2 and 3, the valve body 110 has a valve body main body 120 made of a resin material, a hole 130 that penetrates the valve body main body 120 in the thickness direction (the vertical direction in Figure 2), and a plurality of convex portions 140 that protrude in an arc shape toward the center side of the valve body main body 120 (the side where the central axis c1 of the sheath portion 190 is located) and form the hole 130 on the center side of the valve body main body 120.

[0033] As shown in Figures 3 and 4, in this embodiment, five convex portions 140 are formed at different positions in the circumferential direction of the valve body 110. Each convex portion will be described with a different reference numeral 141, 142, 143, 144, and 145. When these convex portions are collectively referred to, they will be simply referred to as "convex portion 140."

[0034] Each of the multiple convex portions 141, 142, 143, 144, and 145 is configured to transition to a blocked state S2 (see Figure 6) in which the hole 130 is blocked when the valve body main body 120 is compressed, thereby blocking the space between the medical instrument 500 inserted into the hole 130 and the valve body main body 120.

[0035] Fig. 4 shows a state in which the medical device 500 is not inserted through the hole 130 of the valve body 110 and the valve body 110 is not blocked (hereinafter referred to as the "non-blocked state S1"). Fig. 5 shows a state in which the medical device 500 is inserted through the hole 130 of the valve body 110 in the non-blocked state S1.

[0036] In the non-blocking state S1, no external force (for example, a radial compressive force, which will be described later) is applied to the valve body 110 in a direction that blocks the hole 130. Therefore, the surgeon or the like can smoothly insert the medical instrument 500 into the hole 130 of the valve body 110.

[0037] 6 shows a closed state S2 in which an external force is applied to the valve body 110 from the state shown in FIG. 5 to close the space formed between the medical device 500 inserted into the hole 130 and the inner circumferential surface 140a (the inner circumferential surfaces of the multiple convex portions 141, 142, 143, 144, and 145) of the valve body 110. The surgeon or the like can transition the valve body 110 to the closed state S2 by applying an external force to the valve body 110 with the medical device 500 inserted into the hole 130 of the valve body 110. When the introducer sheath 100 transitions to the closed state S2, the multiple convex portions 141, 142, 143, 144, and 145 of the valve body 110 come into intimate contact with the outer surface of the medical device 500. This makes it possible to prevent liquid such as blood from passing between the outer surface of the medical device 500 and the inner circumferential surface 140a of the valve body 110 (from flowing back toward the base end).

[0038] When the valve body 110 transitions to the closed state S2 and each of the multiple convex portions 141, 142, 143, 144, and 145 comes into contact with the outer surface of the medical device 500, each of the multiple convex portions 141, 142, 143, 144, and 145 deforms independently to fit the outer surface of the medical device 500. Therefore, each of the multiple convex portions 141, 142, 143, 144, and 145 closely contacts the outer surface of the medical device 500 so that no excessive space is formed between the valve body 110 and the medical device 500. Therefore, in the closed state S2, the valve body 110 can effectively improve the sealing performance between the medical device 500 and the valve body 110.

[0039] 3, each of the multiple convex portions 141, 142, 143, 144, and 145 is located on the same plane (circumferential surface) centered on the central axis c1. Specifically, each of the multiple convex portions 141, 142, 143, 144, and 145 is located on the same plane that forms the distal end surface of the valve body 110. Therefore, when the valve body 110 transitions to the closed state S2, each of the multiple convex portions 141, 142, 143, 144, and 145 located on the same plane deforms so as to approach each other toward the outer surface of the medical device 500. Therefore, in the closed state S2, the valve body 110 can more effectively improve the sealing performance between the valve body 110 and the outer surface of the medical device 500.

[0040] The surgeon or the like can transition from the blocked state S2 to the non-blocked state S1 by releasing the external force applied to the valve body 110. By operating the application of an external force to the valve body 110 and releasing the application of the external force in this manner, the surgeon or the like can easily and reversibly switch between the blocked state S2 and the non-blocked state S1.

[0041] 3 and 4, the valve body 110 is formed by integrally forming a plurality of convex portions 141, 142, 143, 144, and 145 from a resin material. In other words, the valve body 110 can be formed from a single member that forms the valve body main body 120.

[0042] The resin material constituting the valve element 110 (valve element main body 120) is not particularly limited as long as it can reversibly switch between the closed state S2 and the non-closed state S1 by applying and removing an external force. For example, elastically deformable silicone rubber, latex rubber, butyl rubber, isoprene rubber, etc. can be used as the resin material constituting the valve element 110. When a resin material is used for the valve element 110, the valve element 110 can be manufactured by, for example, a known molding method (such as injection molding).

[0043] Each of the multiple convex portions 141, 142, 143, 144, and 145 has a convex shape that is gently curved toward the central axis c1 in the plan views shown in Figures 4 and 5. When the convex portion 140 transitions to the closed state S2, the convex portions 141, 142, 143, 144, and 145 deform so that they approach each other radially inward toward the central axis c1. As a result, the valve body 110 is brought into close contact with the outer surface of the medical device 500 inserted at the center side of the multiple convex portions 141, 142, 143, 144, and 145 with a uniform pressing force along the circumferential direction. This allows the valve body 110 to more effectively improve the sealing performance between the medical device 500 and the valve body 110.

[0044] In this embodiment, five convex portions 140 are formed on the valve body 110. There is no particular limit to the number of convex portions 140 formed on the valve body 110. However, from the viewpoint of improving the sealing performance in the closed state S2, the number of convex portions 140 is not particularly limited, but for example, an odd number of convex portions 140 may be provided, and further, taking into consideration the complexity of the manufacturing process of the valve body 110, it is more preferable that the number be around five.

[0045] There are no particular limitations on the shape (shape and curvature in plan view in FIG. 4 etc.) of each of the plurality of convex portions 141, 142, 143, 144, 145 that the valve body 110 has, and they can be changed as desired.

[0046] In this embodiment, the lumen structure 150 formed by the hole 130 has a size such that the inner circumferential surface 140a of the convex portion 140 makes point contact (inscribes) with the outer surface of the medical device 500 at multiple locations in the closed state S2 shown in Figures 4 and 5. Since the convex portion 140 of the valve body 110 is configured to have such a size, the medical device 500 can be easily inserted into the hole 130 in the non-closed state S1. Furthermore, when a compressive force is applied from the outer circumferential surface side of the valve body 110 to transition to the closed state S2 as described below, each of the multiple convex portions 141, 142, 143, 144, and 145 can be brought into close contact with the outer surface of the medical device 500, thereby achieving high sealing performance.

[0047] As shown in FIGS. 2 and 3, the hole 130 extends along the thickness direction of the valve body 110 so as to penetrate between the distal end portion 121 and the proximal end portion 123 of the valve body 110 .

[0048] The cross-sectional shape of the hole 130 (shape of the cross section perpendicular to the axis) can be configured to be approximately the same along the thickness direction of the valve body 110, for example. The cross-sectional shape of the hole 130 may be different at any position in the thickness direction. However, by having the hole 130 have approximately the same cross-sectional shape along the thickness direction of the valve body 110 as in this embodiment, a uniform closed state S2 can be created with respect to the outer surface of the medical device 500 at each portion in the thickness direction along which the hole 130 extends, making it possible to achieve higher sealing performance.

[0049] A distal end opening 121a that opens toward the distal end side is formed in the distal end portion 121 of the valve body 110. A proximal end opening 123a that opens toward the proximal end side is formed in the proximal end portion 123 of the valve body 110.

[0050] As shown in FIG. 2, the valve body 110 has a straight portion 125 extending from the base end portion 123 toward the tip side, and a tapered portion 126 located closer to the tip side than the straight portion 125.

[0051] The straight portion 125 has a substantially constant outer diameter and extends along the thickness direction of the valve body 110. The tapered portion 126 is formed so that the outer diameter gradually decreases toward the tip portion 121 of the valve body 110.

[0052] 2, when the valve body 110 is placed in the internal space 161 of the housing 160, the straight portion 125 is disposed so as to face a straight portion 165 located on the inner circumferential surface of the housing 160. The tapered portion 126 is disposed so as to face a tapered portion 166 located on the distal end side of the straight portion 165 of the housing 160.

[0053] The valve disc 110 is disposed with the tapered portion 126 of the valve disc 110 in contact with the tapered portion 166 of the housing 160. When a compressive force is applied in the axial direction, a force can be applied to the valve disc 110 to move it toward the distal end in the axial direction. This allows the valve disc 110 to deform toward the reduced-diameter region of the housing 160. Furthermore, when the valve disc 110 is disposed in the internal space 161 of the housing 160, the straight portion 125 is constrained in a state in which it is surrounded by the straight portion 165 of the housing 160. This limits the valve disc 110 from expanding radially outward when a compressive force is applied to the valve disc 110 in the axial direction. This causes the valve disc 110 to deform so as to be compressed radially inward so that each of the multiple convex portions 141, 142, 143, 144, and 145 approaches each other.

[0054] As shown in FIG. 2, the housing 160 has an internal space 161 in which the valve body 110 is disposed.

[0055] A side port 168 is provided in the internal space 161 of the housing 160 at a position distal to the position where the valve body 110 is disposed. As shown in Fig. 1, the side port 168 is connected to a three-way stopcock 230 via a predetermined tube 220. The three-way stopcock 230 and the tube 220 are used to supply a liquid such as physiological saline into the housing 160.

[0056] A connecting portion 167 is provided at the base end portion 123 of the housing 160, to which the cap member 180 can be attached. The connecting portion 167 can be configured, for example, by a threaded portion (male threaded portion or female threaded portion) that can be screwed into a connecting portion 181 (female threaded portion or male threaded portion) provided on the cap member 180.

[0057] The inner peripheral surface of the internal space 161 of the housing 160 is provided with a straight portion 165 for holding the valve body 110 and a tapered portion 166 .

[0058] A strain relief portion 210 that covers the tip portion 121 of the housing 160 is disposed on the tip side of the housing 160 .

[0059] The introducer sheath 100 is disposed in the housing 160 and has a pressing portion 170 that radially compresses the valve body main body 120 as it moves vertically (the same direction as the axial direction), transitioning each of the multiple convex portions 141, 142, 143, 144, and 145 to the closed state S2.

[0060] As described above, the valve element 110 is held by the tapered portion 126 of the housing 160 in the internal space 161 of the housing 160 and is disposed in a state in which radially outward expansion is restricted (restrained state). In this state, when the pressing portion 170 moves vertically toward the valve element 110 and presses the valve element 110, the valve element 110 contracts radially inward to reduce the diameter of the hole 130. When the valve element 110 contracts radially inward, the space between the outer surface of the medical device 500 and the multiple convex portions 141, 142, 143, 144, and 145 is closed. Therefore, the surgeon or the like can easily and reversibly switch between the non-blocking state S1 and the blocking state S2 by moving the pressing portion 170 vertically toward or away from the valve element 110.

[0061] In particular, in this embodiment, when the pressing portion 170 is operated, the valve element 110 is subjected to a vertical external force while the tapered portion 126 of the valve element 110, whose outer diameter gradually decreases toward the tip side, is disposed in the tapered portion 166 of the housing 160, and therefore the tapered portion 126 and the vicinity of the tip portion 121 of the valve element 110 can be effectively compressed radially inward. This effectively improves the sealing performance in the vicinity of the tapered portion 126 and the tip portion 121 of the valve element 110.

[0062] The pressing portion 170 is disposed closer to the base end of the housing 160 than the valve body main body 120 and has a cap member 180 that applies a pressing force to the valve body main body 120 as it is screwed into the housing 160 .

[0063] The cap member 180 has a connecting portion 181 that can be screwed onto the connecting portion 167 of the housing 160, a pressing end 182 that presses the base end surface of the valve body 110 as it moves vertically toward the valve body 110, and a through hole 183 through which the medical device 500 can be inserted.

[0064] The surgeon can move the cap member 180 toward the valve disc 110 by screwing the cap member 180. Furthermore, the surgeon can apply a pressing force to the valve disc 110 and compressively deform the valve disc 110 in the radial direction by further screwing the cap member 180 while the pressing end 182 of the cap member 180 is in contact with the base end surface of the valve disc 110 (see the arrows in FIG. 2). By manipulating the cap member 180 in this manner, the surgeon can easily adjust the amount of compressive deformation of the valve disc 110 in the radial direction. Furthermore, by manipulating the cap member 180, the surgeon can continuously increase or decrease the amount of compressive deformation of the valve disc 110 in the radial direction, and can easily switch between the closed state S2 and the non-closed state S1.

[0065] Note that the pressing portion 170 is not particularly limited as long as it has a configuration that can compress the valve body 110 in the radial direction in conjunction with vertical movement as described above. The pressing portion 170 can also be configured, for example, with something other than the cap member 180. As one example, the pressing portion 170 can be configured to include a mechanism similar to a knock cam mechanism that is used in the field of medical devices such as catheters to control the compression (tightening) and opening of valve bodies.

[0066] From the viewpoint of enabling radial compressive deformation of the valve body 110 arranged in the internal space 161 of the housing 160, it is preferable that the housing 160 and the pressing portion 170 (cap member 180) are made of a resin material (e.g., ABS resin, polycarbonate resin, etc.) or a metal material that is relatively harder than the valve body 110.

[0067] (Dilator 300) As shown in FIG. 1, the dilator 300 has a dilator body 310 that can be inserted into the lumen 195 of the sheath portion 190 of the introducer sheath 100, and a dilator hub 320 that is fixed to the proximal end side of the dilator body 310.

[0068] The dilator 300 can be used to prevent the sheath portion 190 from bending when the sheath portion 190 is inserted into a biological lumen, and to expand the diameter of the puncture (perforation) formed in the limb and blood vessel wall, which are the insertion points into the body.

[0069] The dilator hub 320 can be configured to be mechanically detachable from the housing 160.

[0070] As described above, the introducer sheath 100 according to this embodiment is an introducer sheath comprising: a valve body 110 through which one or more medical instruments 500 to be inserted into a living body are inserted; a housing 160 in which the valve body 110 is held; and a sheath portion 190 comprising an inner cavity 195 through which one or more medical instruments 500 can be inserted. The valve body 110 has a valve body main body 120 made of a resin material, a hole 130 penetrating the valve body main body 120 in the thickness direction, and a plurality of convex portions 141, 142, 143, 144, 145 that protrude in an arc shape toward the center of the valve body main body 120 and form the hole 130 on the center side of the valve body main body 120, and each of the plurality of convex portions 141, 142, 143, 144, 145 is configured to transition to a blocked state S2 in which the hole 130 is blocked when the valve body main body 120 is compressed, and to block the space between the valve body main body 120 and one or more medical instruments 500 inserted into the hole 130.

[0071] The sheath portion 190 according to this embodiment transitions to a closed state S2 in which the plurality of convex portions 141, 142, 143, 144, and 145 close the hole 130 by compressing the valve body main body 120. When the plurality of convex portions 141, 142, 143, 144, and 145 transition to the closed state S2, each of the plurality of convex portions 141, 142, 143, 144, and 145 comes into contact with the outer surface of one or more medical instruments 500 inserted into the valve body 110, thereby closing the space between the valve body 110 and the one or more medical instruments 500. Therefore, even when the sheath portion 190 has a large diameter, it is possible to effectively prevent fluid such as blood from leaking out of the introducer sheath 100 through between the valve body 110 and the one or more medical instruments 500. Furthermore, by performing the operation of applying a compressive force to the valve body 110 and the operation of releasing the compressive force applied to the valve body 110, the occlusion state S2 and the non-occlusion state S1 can be easily switched, thereby preventing the procedure using the introducer sheath 100 from becoming complicated.

[0072] <Modifications of the valve body> Next, a modified example of the valve body 110 will be described.

[0073] In the first embodiment described above, the valve body 110 is illustrated as having five convex portions 140. However, there is no particular limit to the number of convex portions 140 that one valve body 110 has.

[0074] As shown in Fig. 7, the valve body 110 can be configured to have, for example, three convex portions 141, 142, and 143 arranged at equal intervals in the circumferential direction. Alternatively, as shown in Fig. 8, the valve body 110 can be configured to have, for example, seven convex portions 141, 142, 143, 144, 145, 146, and 147 arranged at equal intervals in the circumferential direction. Each valve body 110 shown in Figs. 7 and 8 is configured such that, when one or more medical instruments 500 are inserted through the hole 130 in the non-occluded state S1, the outer surface of the medical instrument 500 comes into point contact (inscribed in the inner circumferential surface 140a) of the convex portion 140 at multiple locations.

[0075] Second Embodiment Next, a valve body 110A according to the second embodiment will be described. Note that the description of each part of the introducer sheath 100 other than the valve body 110A can be the same as that of the first embodiment, and therefore, the contents already described will be omitted as appropriate.

[0076] FIG. 9 shows a valve body 110A according to the second embodiment and a biasing member 400 used for the valve body 110A.

[0077] As shown in FIG. 9, the valve body 110A has three convex portions 141, 142, and 143.

[0078] The valve body main body is composed of multiple segments 120A, 120B, and 120C made of a resin material that form multiple convex portions 141, 142, and 143. In other words, valve body 110A is composed of an assembly of segment 120A on which convex portion 141 is formed, segment 120B on which convex portion 142 is formed, and segment 120C on which convex portion 143 is formed.

[0079] 10, the valve body 110A, which is made up of multiple segments 120A, 120B, and 120C, is arranged so as to be in partial contact with one another by the biasing member 400. The valve body 110A configured in this manner can function similarly to the valve body 110 described in the first embodiment. That is, when one or more medical instruments 500 are inserted into the hole 130 formed on the center side of the valve body 110, the convex portions 141, 142, and 143 provided on each of the multiple segments 120A, 120B, and 120C deform so as to come into contact with the outer surfaces of the one or more medical instruments 500, thereby blocking the spaces between the one or more medical instruments 500 and the respective convex portions 141, 142, and 143.

[0080] The plurality of divided pieces 120A, 120B, 120C are arranged so as to form a hole 130 on the center side of the valve body 110A when assembled together.

[0081] Each of the plurality of divided pieces 120A, 120B, 120C can be made of the same resin material as the aforementioned example of the constituent material of the valve body 110.

[0082] As shown in Figures 10, 11, and 12, the biasing member 400 is arranged to cover the periphery of the valve body main body (the periphery of each of the divided pieces 120A, 120B, and 120C) and is configured to apply a radial compressive force to the valve body main body.

[0083] The biasing member 400 is configured to allow one or more medical instruments 500 to be inserted into the hole 130 when a compressive force is applied to the valve body, while maintaining the compressive force applied so that the space between the one or more medical instruments 500 and the valve body is closed when the one or more medical instruments 500 are inserted into the hole 130.

[0084] As shown in FIG. 10 , the biasing member 400 applies a compressive force to each of the segments 120A, 120B, and 120C in the non-blocking state S1 before the medical device 500 is inserted through the hole 130. The biasing member 400 deforms each of the segments 120A, 120B, and 120C to reduce the diameter of the hole 130 and maintains this state. As shown in FIG. 11 , when one or more medical devices 500 are inserted through the hole 130, the segments 120A, 120B, and 120C deform to adhere closely to the outer surface of the medical device 500. When one or more medical devices 500 are inserted through the hole 130, the biasing member 400 widens the hole 130 to allow the insertion of the one or more medical devices 500. However, the biasing member 400 only allows the hole 130 to widen to the extent that allows the insertion of the one or more medical devices 500. The biasing member 400 maintains a seal by bringing the plurality of convex portions 141, 142, 143 into close contact with the outer surface of one or more medical devices 500.

[0085] The biasing member 400 and the valve body 110A can be placed at a predetermined position in the internal space 161 of the housing 160 (see Figure 2) with the biasing member 400 covering the periphery of the valve body 110A (for example, the periphery of the straight portion 125).

[0086] A description will be given of an example of the biasing member 400. Note that the biasing member 400 is not limited to the configuration described below.

[0087] As shown in FIG. 9, the biasing member 400 has a ring-shaped main body portion 401 having an inner cavity 405 formed therein, a notched insertion portion 401a formed in a part of the main body portion 401, and an inserted portion 403 inserted into the insertion portion 401a.

[0088] The straight portion 125 of the valve body 110A can be placed in the bore 405 of the main body 401. The bore 405 can be configured to have an inner diameter smaller than the outer diameter of the straight portion 125 of the valve body 110A (for example, an inner diameter large enough to apply a predetermined diameter-reducing force to the straight portion 125 when the straight portion 125 of the valve body 110A is placed in the bore 405).

[0089] The insertion portion 403 is movable within the range in which the insertion portion 401a extends. One end 403a of the insertion portion 403 and the end 401b of the main body portion 401 protrude radially outward from the biasing member 400. The biasing member 400 controls the amount of radial expansion and deformation of the valve body 110A when the straight portion 125 of the valve body 110A is disposed in the lumen 405. For example, as shown in FIG. 14 , when one or more medical instruments 500 are inserted by pushing them through the hole 130, the one end 403a moves within the insertion portion 401a, widening the inner diameter of the lumen 405. At this time, the lumen 405 expands until the one end 403a abuts against the end 401b. In this way, the biasing member 400 has the function of applying a biasing force to the valve body 110A while covering the valve body 110A, and allows one or more medical instruments 500 with a predetermined outer diameter to be inserted into the inner cavity 405 while maintaining the biasing force applied.

[0090] The biasing member 400 can be made of a material (such as a metal material) that is harder than the valve body 110A (each of the segments 120A, 120B, and 120C) and has elasticity, for example. However, there are no particular limitations on the specific material that makes up the biasing member 400.

[0091] The valve body 110A used in this embodiment is preferably configured so that, for example, when the medical device 500 is projected onto a plan view of the valve body 110A in the non-occluded state S1, the outer surface of the medical device 500 is in contact with the outermost end of the hole 130 (the positional relationship described in FIGS. 9 to 11 above). In this configuration, one or more medical devices 500 are inserted into the hole 130 when the area of ​​the hole 130 is relatively small in plan view, as shown in FIG. 10. This makes it possible to more reliably close the space between the outer surfaces of the one or more medical devices 500 and the plurality of convex portions 141, 142, 143 when the one or more medical devices 500 are inserted into the hole 130.

[0092] <Modifications of the valve body> In the second embodiment described above, the valve body 110A includes three segments 120A, 120B, and 120C (three convex portions 141, 142, and 143). However, there is no particular limit to the number of segments 120A, 120B, and 120C that make up one valve body 110A.

[0093] As shown in Fig. 12, the valve body 110A can be made up of, for example, five segments 120A, 120B, 120C, 120D, and 120E arranged at equal intervals in the circumferential direction. Alternatively, as shown in Fig. 13, the valve body 110A can be made up of, for example, seven segments 120A, 120B, 120C, 120D, 120E, 120F, and 120G arranged at equal intervals in the circumferential direction.

[0094] 12 and 13 illustrate valve bodies 110A configured in a positional relationship such that, when one or more medical instruments 500 are inserted through the hole 130 in the non-occluding state S1, the outer surface of the medical instrument 500 circumscribes the outermost end of the hole 130. However, as shown in FIGS. 14 to 16, the valve body 110A can also be configured such that, when one or more medical instruments 500 are inserted through the hole 130 in the non-occluding state S1, the outer surface of the medical instrument 500 makes point contact (inscribes) with the inner circumferential surface of each segment at multiple locations. Note that, with such a configuration, it is considered difficult to achieve a high level of sealing compared to the above-described circumscribed configuration, and therefore the valve body 110A of the second embodiment is preferably configured to achieve a circumscribed positional relationship.

[0095] In the first and second embodiments, holes 130 are exemplified as the lumen structure provided in the valve body. However, for example, slits may be provided in the valve body instead of holes. Even when slits are provided in the valve body, the same effects as those described in the first and second embodiments can be achieved. Furthermore, the valve body can also be configured with both holes and slits. In such a configuration, for example, by providing holes in a portion of the valve body in the thickness direction and providing slits in a position in the thickness direction of the valve body other than the position where the holes are provided, substantially the same effects can be achieved.

[0096] The introducer sheath according to the present invention has been described above through embodiments, but the present invention is not limited to the configurations described above and can be modified as appropriate based on the claims.

[0097] The structure of each part and the arrangement of the members described in the specification may be changed as desired. Additional members illustrated in the drawings may be omitted, or other additional members may be used as desired. [Explanation of symbols]

[0098] 10. Introducer 100 Introducer Sheath 110 Valve body 110A Valve body 120 Valve body 120A split piece 120B split piece 120C split piece 125 Straight part of valve body 126 Tapered portion of valve body 130 holes 140 Convex part 140a: inner peripheral surface of convex portion 150 Luminal structure 160 Housing 161 Interior Space 165 Straight part of housing 166 Tapered part of housing 167 Housing connection 170 Pressing part 180 Cap member 190 Sheath 195 Lumen of sheath 300 Dilator 400 biasing member 500 Medical Equipment S1 Unblocked state S2 Blocked state

Claims

1. a valve body through which one or more medical instruments to be inserted into a living body are inserted; a housing in which the valve body is held; a sheath portion having an inner lumen into which the one or more medical instruments can be inserted, The valve body is a valve body made of a resin material; a slit and / or a hole penetrating the valve body in a thickness direction; a plurality of convex portions that protrude in an arc shape toward the center of the valve body main body and form the slits and / or the holes on the center side of the valve body main body, an introducer sheath, wherein each of the plurality of convex portions is configured to transition to a closed state in which the slits and / or the holes are closed when the valve body is compressed, thereby closing the space between the one or more medical instruments inserted into the slits and / or the holes and the valve body.

2. The sheath for introducer according to claim 1 , wherein the valve body main body has a plurality of convex portions each integrally formed from the resin material.

3. 3. The sheath for introducer according to claim 2, further comprising a pressing portion disposed in the housing, the pressing portion radially compressing the valve body as the valve body moves vertically, thereby transitioning each of the plurality of convex portions to the closed state.

4. The sheath for introducer according to claim 3 , wherein the pressing portion has a cap member that is disposed closer to the base end of the housing than the valve body and that applies a pressing force to the valve body as the cap member is screwed into the housing.

5. The sheath for introducer according to claim 1 , wherein the valve body main body is configured by a plurality of divided pieces made of the resin material that form the plurality of convex portions, respectively.

6. a biasing member disposed so as to surround the valve body and applying a compressive force to the valve body in a radial direction; 6. The introducer sheath according to claim 5, wherein the biasing member is configured to allow the one or more medical instruments to be inserted into the slits and / or the holes when the compressive force is applied to the valve body, and to maintain the compressive force applied so that a space between the one or more medical instruments and the valve body is closed when the one or more medical instruments are inserted into the slits and / or the holes.

7. The sheath for introducer according to any one of claims 1 to 6, wherein each of the plurality of convex portions is arranged on the same plane.

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