Medical instrument

Abstract

[Problem] To provide a medical instrument that makes it possible to selectively switch between an open state and a closed state of a hemostatic valve assembly by means of a simple operation and smoothly insert a dilator or a medical device even when in the closed state. [Solution] A hemostatic valve assembly 200 is configured so that performing knock operation of a cap member 220 makes it possible to switch between: a first mode that is an open state in which a space A between a tip surface 241a of a rotor 240 positioned in a retreat position Bp and a base section 216 has a first volume V1 and an insertion hole 255 in a seal member 250 is open; and a second mode that is a closed state in which the space between the tip surface of the rotor positioned in an advance position Fp and the base section 216 has a second volume V2 smaller than the first volume, the seal member is compressed in the longitudinal direction thereof, and the insertion hole is thereby closed.

Description

medical equipment

[0001] The present invention relates to a medical device.

[0002] BACKGROUND ART Medical instruments such as sheath introducers used to insert medical devices into biological lumens (for example, blood vessels) have been known.

[0003] The medical device includes a hollow tubular sheath member (sheath tube) and a hemostatic valve assembly disposed at the proximal end of the sheath member. The hemostatic valve assembly includes a housing member having a valve body disposed therein.

[0004] In a procedure using the above-described medical device, a surgeon inserts a dilator into a sheath member and then percutaneously inserts the sheath member into a biological lumen. The surgeon then removes the dilator from the sheath member while leaving the distal end of the sheath member inserted into the biological lumen. With the dilator removed from the sheath member, the surgeon can use the lumen of the sheath member as an access path connecting the biological lumen to the outside of the body, allowing the surgeon to insert various medical devices used for treatment or diagnosis into the biological lumen.

[0005] The valve element disposed in the housing member prevents blood or a liquid such as physiological saline injected into the housing member from flowing back toward the proximal end of the cap member connected to the housing member. As an example of such a valve element, Patent Document 1 discloses a valve element having a slit formed therein that allows a dilator or a medical device to be inserted into a blood vessel to pass therethrough.

[0006] When inserting a dilator or medical device into the valve body of Patent Document 1, the surgeon inserts the dilator or medical device into the housing member from the proximal end side of the medical instrument and pushes the dilator or medical device toward the slit in the valve body. When the tip of the dilator or medical device hits the valve body, the valve body guides the tip into the slit and inserts the dilator or medical device into the distal side of the valve body through the slit.

[0007] When a dilator or medical device is inserted through the valve body, the valve body adheres tightly to the outer surface of the dilator or medical device that has been inserted through the inner periphery of the valve body via the slit, thereby forming a seal between the dilator or medical device.

[0008] The above-mentioned valve body is configured to keep the slit constantly closed even before a dilator or medical device is inserted. Therefore, when an operator inserts a dilator or medical device into the valve body through the slit, the dilator or medical device experiences a relatively large insertion resistance. This forces the operator to push the dilator or medical device toward the slit with a large force in order to widen the slit. As such, the operator must apply a large amount of force to insert the dilator or medical device into the valve body, which can make it difficult to smoothly perform the procedure when using a medical tool equipped with the above-mentioned valve body.

[0009] In particular, in medical devices intended for use in relatively large blood vessels such as the arteries of the lower limbs, the sheath member is configured with a large diameter, and accordingly the hemostatic valve assembly and valve body are also configured with a large diameter. Therefore, when inserting the dilator or medical device into the valve body as described above, a greater pushing force is required, which can further increase the burden on the surgeon, etc.

[0010] In relation to the above-mentioned problems, Patent Document 2 discloses a medical device equipped with a hemostatic valve assembly having a fluid-driven valve body that can control the opening and closing of an internal passage through which a dilator or medical device can be inserted by injecting and discharging fluid.

[0011] WO2016 / 183392 JP2022-27860

[0012] The valve body of Patent Document 2 is composed of a flexible bag (container) into which a fluid can be injected. By injecting a predetermined amount of fluid into the valve body and expanding the valve body, the surgeon can switch the internal passage to a closed state (sealed state). When the surgeon attempts to insert a dilator or medical device into the internal passage in this closed state, the valve body, which is composed of a deformable, flexible bag as described above, can deform to some extent to expand the diameter of the internal passage in accordance with the outer diameter of the dilator or medical device. Therefore, when the surgeon inserts a dilator or medical device into the valve body of Patent Document 2 in a closed state of the internal passage, the surgeon can insert the dilator or medical device more smoothly with less pushing force than when inserting the dilator or medical device into the valve body of Patent Document 1 with a slit.

[0013] However, when a mechanism for switching between opening and closing an internal passage using a fluid, such as the valve body of Patent Document 2, is employed, the surgeon must use a fluid injection device such as a syringe to inject and discharge fluid into and from the valve body during the procedure, in addition to the work of inserting a sheath member into a blood vessel and holding the sheath member at a predetermined position in the living body.This makes the procedure using the medical tool cumbersome.

[0014] The present invention has been made to solve the above-mentioned problems, and aims to provide a medical device that allows the hemostatic valve assembly to be selectively switched between an open state and a closed state with a simple operation, and that allows a dilator or medical device to be smoothly inserted even in the closed state.

[0015] The present invention can be achieved by any one of the following means (1) to (5).

[0016] (1) A hemostatic valve assembly having a tubular sheath member and connected to a proximal end of the sheath member, wherein the hemostatic valve assembly comprises: a housing member having a through hole extending from the distal end to the proximal end and a base portion located midway along the through hole; a cap member protruding from the proximal end of the housing member and having an opening communicating with the through hole; a tubular pushing member connected to the cap member, protruding along the through hole and having an internal space communicating with the opening; a tubular rotor disposed within the housing member and having an internal space communicating with the internal space of the pushing member on the distal side of the pushing member; and a seal member located distal to the rotor, disposed on the base portion, and having an insertion hole communicating with the through hole. The hemostatic valve assembly is configured so that the rotor can be engaged in a retracted position located inside the housing member and an advanced position by knocking the cap member to move the pushing member back and forth and rotate the rotor in conjunction with the back and forth movement, and the hemostatic valve assembly is configured so that it can be switched between a first form in which the space between the tip surface of the rotor located in the retracted position and the base portion has a first volume and the insertion hole of the sealing member is in an open state, and a second form in which the space between the tip surface of the rotor located in the advanced position and the base portion has a second volume smaller than the first volume and the sealing member is compressed in the longitudinal direction to block at least a portion of the insertion hole.

[0017] (2) The medical device according to (1), wherein the inner cavity of the sheath member, the internal space of the pushing member, and the internal space of the rotor are coaxially arranged.

[0018] (3) The medical device according to (1) or (2), wherein the pushing member has a first cam groove formed on its distal end surface, the rotor has a convex portion formed with a cam surface that can engage with the first cam groove, the housing member has a second cam groove provided on its inner surface at a position closer to the base end than the base portion and that can engage with the cam surface, and the hemostatic valve assembly, when the cap member is knocked in the first form, guides the movement of the convex portion while engaging the first cam groove with the cam surface, thereby guiding the convex portion to a position where the cam surface engages with the second cam groove, and further moves the convex portion along the second cam groove to position the convex portion at an engagement position provided in the second cam groove.

[0019] (4) A medical device according to any one of (1) to (3), wherein the hemostatic valve assembly has a spacer located inside the housing member, between the rotor and the seal member, and the spacer has a base end surface that abuts against the tip end surface of the rotor and a tip end surface that abuts against the base end surface of the seal member.

[0020] (5) The medical device according to any one of (1) to (4), wherein the housing member has a window portion that allows a part of the rotor to be visible from the outside in the second configuration.

[0021] The hemostatic valve assembly of the medical device of the present invention is configured such that, by knocking the cap member, the pushing member moves back and forth, rotating the rotor in accordance with the back and forth movement, thereby locking the rotor between a retracted position located inside the housing member and an advanced position. The hemostatic valve assembly is also configured to be switchable between a first configuration in which, in the retracted position, the space between the distal end surface of the rotor and the base has a first volume and the insertion hole of the seal member is open, and a second configuration in which, in the advanced position, the space between the distal end surface of the rotor and the base has a second volume smaller than the first volume and the seal member is compressed in the longitudinal direction to at least partially close the insertion hole. In the hemostatic valve assembly configured as described above, when the cap member is knocked, the pushing member moves toward the distal end, rotating the rotor within the housing member and advancing the rotor toward the distal end, thereby pressing the seal member located at the distal end of the pushing member against the base of the housing member. As described above, the hemostatic valve assembly compresses the seal member longitudinally by pressing the seal member against the base portion with the pushing member. By compressing the seal member longitudinally, the hemostatic valve assembly can form an occlusion portion in the seal member, closing the insertion hole. The hemostatic valve assembly can efficiently compress the seal member longitudinally by applying a force from the rotor, which moves toward the distal end as the pushing member advances, to the seal member, pressing the seal member against the base portion of the housing member. Furthermore, after being switched to the occlusion state, the hemostatic valve assembly can preferably maintain the sealing performance of the occlusion portion formed in the seal member by locking the rotor in the advanced position. Furthermore, since the hemostatic valve assembly is configured to form an obstruction section in which the insertion hole is blocked by compressing the sealing member longitudinally using the pushing member as described above, when a dilator or medical device is inserted into the sealing member while an obstruction section is formed in the sealing member (closed state), the sealing member can be deformed so that the obstruction section is pushed open to match the outer diameter of the dilator or medical device while maintaining close contact between the dilator or medical device and the obstruction section.Therefore, when the surgeon operates the pushing member to switch to the closed state, the surgeon can smoothly insert a dilator or medical device into the seal member without impairing the sealing properties of the occlusion part formed in the seal member. As described above, according to the present invention, it is possible to provide a medical device in which the hemostatic valve assembly can be selectively switched between the open state and the closed state by a simple operation, and in which a dilator or medical device can be smoothly inserted even in the closed state.

[0022] FIG. 1 is a diagram illustrating an introducer circuit according to an embodiment. FIG. 2 is a partial cross-sectional view of a hemostasis valve assembly in an open state (first form). FIG. 3 is an exploded perspective view of the hemostasis valve assembly. FIG. 4 is an enlarged perspective view for explaining the operation of the hemostasis valve assembly. FIG. 5 is an enlarged perspective view for explaining the operation of the hemostasis valve assembly. FIG. 6 is an enlarged perspective view for explaining the operation of the hemostasis valve assembly. FIG. 7 is a partial cross-sectional view of a hemostasis valve assembly in a closed state (second form). FIG. 8 is an enlarged perspective view for explaining the operation of the hemostasis valve assembly. FIG. 9 is an enlarged perspective view for explaining the operation of the hemostasis valve assembly. FIG. 10 is a diagram for explaining the function of a window portion provided in a housing member. FIG. 11 is a diagram for explaining the function of a window portion provided in a housing member.

[0023] (Embodiment) Hereinafter, a medical device 10 according to an embodiment will be described with reference to Figs.

[0024] FIG. 1 is a diagram schematically illustrating the overall configuration of the introducer circuit 1. FIG. 2 is a partial cross-sectional view (longitudinal cross-sectional view along the axial direction) of the hemostatic valve assembly 200 in the open state (first mode). FIG. 3 is an exploded perspective view of the hemostatic valve assembly 200. FIGS. 4 to 6, 8, and 9 are enlarged perspective views for explaining the operation of the hemostatic valve assembly 200. FIG. 7 is a partial cross-sectional view (longitudinal cross-sectional view along the axial direction) of the hemostatic valve assembly 200 in the closed state (second mode). FIGS. 10 and 11 are front views for explaining the function of the window portion 219 provided in the housing member 210.

[0025] 1, in this embodiment, an example in which a medical device 10 is applied to a sheath introducer will be described. In addition, when describing the medical device 10, an introducer circuit 1 including the medical device 10 will be described.

[0026] <Introducer Circuit 1 > As shown in FIG. 1 , the introducer circuit 1 includes a medical device 10 and a dilator 300 .

[0027] <Medical Device 10> As shown in FIGS. 1 and 2, the medical device 10 includes a tubular sheath member 100 and a hemostatic valve assembly 200 connected to the proximal end portion 103 of the sheath member 100.

[0028] The medical device 10 can be used to introduce various medical devices into a biological lumen (e.g., a blood vessel) via the lumen 105 (see FIG. 2 ) of the sheath member 100. Specific methods and procedures for using the medical device 10 are not particularly limited, but for example, the medical device 10 can be used to form an access path for delivering various medical devices (e.g., a stent for placement in the aorta, a device used in artificial valve replacement surgery to treat aortic stenosis, a device for treating pulmonary thrombosis, etc.) from a relatively large-diameter blood vessel running through the lower limb to various parts of the living body, using the blood vessel in the lower limb as the insertion target site.

[0029] In the description of this specification, the direction in which the sheath member 100 extends is referred to as the "axial direction" and is indicated by arrows X1-X2. The direction indicated by arrow X1 is defined as the distal end side of the axial direction, and the direction indicated by arrow X2 is defined as the proximal end side of the axial direction. In each drawing, the direction perpendicular to the axial direction is indicated by arrows Y1-Y2.

[0030] The axial direction of the sheath member 100 is parallel to the central axis c1 of the sheath member 100. The longitudinal direction of the housing member 210 and the longitudinal direction of the seal member 250 are also the same as the axial direction of the sheath member 100.

[0031] <Sheath member 100> As shown in Figs. 1 and 2, the sheath member 100 has a distal end portion 101 having a distal end opening 101a formed at the most distal end position, and a proximal end portion 103 disposed in a distal end region 215a of the through-hole 215 of the housing member 210.

[0032] The proximal end 103 of the sheath member 100 is disposed at a position closer to the distal end than the ports 271, 272 provided in the housing member 210. The proximal end 103 of the sheath member 100 is provided with a proximal end opening 103a that communicates with the through-hole 215 of the housing member 210.

[0033] The sheath member 100 has an inner lumen 105 that extends continuously between the distal opening 101a and the proximal opening 103a.

[0034] The sheath member 100 can be made of, for example, a polymer material such as polyolefin (e.g., polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyolefin elastomer, crosslinked polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin (e.g., polytetrafluoroethylene, tetrafluoroethylene-ethylene copolymer), polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide, polyether ether ketone, or a mixture thereof. The sheath member 100 may also have a reinforcing member such as a metal wire within the wall thickness of the tubular member made of a polymer material or a mixture thereof.

[0035] <Hemostatic valve assembly 200> As shown in Figures 2 and 3, the hemostatic valve assembly 200 comprises a housing member 210 having a through hole 215 extending from the distal end 211 toward the proximal end 213 and a base portion 216 located midway along the through hole 215, a cap member 220 protruding from the proximal end 213 of the housing member 210 and having an opening 225 communicating with the through hole 215, a tubular pushing member 230 connected to the cap member 220 and protruding along the through hole 215 while having an internal space 235 communicating with the opening 225, a tubular rotor 240 disposed within the housing member 210 and having an internal space 245 communicating with the internal space 235 of the pushing member 230 on the distal side thereof, and a seal member 250 located distal to the rotor 240 and disposed in the base portion 216, and having an insertion hole 255 communicating with the through hole 215.

[0036] 2 , a distal end portion 221 of a cap member 220 is inserted into a proximal end region 215b of the through-hole 215 of the housing member 210. A proximal end portion 223 of the cap member 220 is disposed so as to protrude from the proximal end 213 of the housing member 210 toward the proximal end side.

[0037] As shown in FIG. 2, the base portion 216 of the housing member 210 is disposed at a position closer to the proximal end than a distal end region 215a in which the proximal end portion 103 of the sheath member 100 is disposed.

[0038] The base portion 216 has a support surface 216a on which the tip surface 251a of the seal member 250 arranged on the base portion 216 is arranged, and a side portion 216b extending along the axial direction from the support surface 216a toward the base end side.

[0039] A support surface 216a of the base portion 216 extends substantially parallel to a tip surface 251a of the seal member 250. In this embodiment, the support surface 216a extends substantially perpendicular to the central axis c1.

[0040] 3, an opening 212 is provided at a base end 213 of the housing member 210. The seal member 250, the spacer 260, the rotor 240, a portion of the pushing member 230, and a portion of the cap member 220 can be disposed inside the housing member 210 through the opening 212 in this order.

[0041] The opening 225 of the cap member 220 penetrates between the base end 223 and the tip end 221 of the cap member 220 .

[0042] 2 , the opening 225 of the cap member 220 can be configured to have a tapered cross section in which the inner diameter decreases from the base end 223 toward the tip end 221. By forming the cross section of the opening 225 of the cap member 220 in the above-described tapered shape, when inserting the dilator 300 or a medical device into the through-hole 215 of the housing member 210 through the opening 225 of the cap member 220, it becomes possible to guide the dilator 300 or the medical device toward the center of the housing member 210 located on the central axis c1 side of the sheath member 100.

[0043] The base end 223 of the cap member 220 remains positioned so as to protrude toward the base end side of the housing member 210 regardless of whether the pushing member 230 is positioned in the retracted position Bp (see Figure 2) or the advanced position Fp (see Figure 7).

[0044] The base end 223 of the cap member 220 can be used as a finger hook on which the operator or the like places his or her fingers when the cap member 220 is knocked.

[0045] 3 , the base end 223 of the cap member 220, which is arranged to protrude from the through-hole 215 of the housing member 210, can be configured to have a polygonal shape (e.g., a hexagonal shape) in a plan view. By forming the base end 223 of the cap member 220 in a polygonal shape as described above, it becomes easier for an operator to place his or her fingers on the base end 223 of the cap member 220 when performing a knock operation on the cap member 220. This allows the operator to place the fingers of one hand on the cap member 220 and easily perform a knock operation on the cap member 220 with one hand.

[0046] A finger hook 227 protruding from the base end 223 can be provided on the side surface 226 of the base end 223 of the cap member 220. When the cap member 220 is configured to include the finger hook 227, the surgeon or the like can hook their fingers on the finger hook 227 to knock the cap member 220. This allows the surgeon or the like to perform the knock operation of the cap member 220 more easily and smoothly.

[0047] A tip end portion 231 of the pushing member 230 is disposed within the through-hole 215 of the housing member 210. When the pushing member 230 is located at the retracted position Bp (see FIG. 2 ) and when the pushing member 230 is located at the advanced position Fp (see FIG. 7 ), the tip end portion 231 of the pushing member 230 is disposed at a position closer to the base end of the through-hole 215 than the protrusion 246 of the rotor 240.

[0048] 2 , a portion of the rotor 240 on the side of its base end 243 is inserted into the internal space 235 of the pushing member 230. When the pushing member 230 moves back and forth, the pushing member 230 moves along the base end 243 of the rotor 240 inserted into the internal space 235 of the pushing member 230.

[0049] A base end 233 of the pushing member 230 is disposed so as to protrude from the base end 213 of the housing member 210 toward the base end. The base end 233 of the pushing member 230 protruding from the base end 213 of the housing member 210 is fitted into a fitting groove 228 provided in the cap member 220. The pushing member 230 is connected to the cap member 220 via the base end 233 and the fitting groove 228. By being connected to the cap member 220, the pushing member 230 moves together with the cap member 220 when the cap member 220 moves along the through-hole 215 of the housing member 210 due to a knocking operation, which will be described later.

[0050] 3, a protrusion 236a extending in the axial direction is provided near the tip end 231 of the pushing member 230. The pushing member 230 has a plurality of protrusions 236a arranged at different positions in the circumferential direction of the pushing member 230.

[0051] As shown in Figure 4, the convex portion 236a is inserted into an insertion groove 217a formed on the inner surface of the housing member 210, and guides the movement of the pushing member 230 so that the pushing member 230 moves linearly along the axial direction when the pushing member 230 moves back and forth.

[0052] As shown in Figures 2 and 3, the rotor 240 has a base end 243 inserted into the internal space 235 of the pushing member 230 and a tip end 241 arranged on the side of the sealing member 250 located at the tip side of the rotor 240.

[0053] 3, the base end 243 of the rotor 240 is formed to have a smaller diameter than the tip end 241 of the rotor 240. The tip end 241 of the rotor 240 has approximately the same outer diameter as the spacer 260 and the seal member 250 that are arranged further tip-side than the tip end 241.

[0054] The rotor 240 includes a protrusion 246 that is arranged to straddle the vicinity of the boundary between the tip end 241 of the rotor 240 and the base end 243 of the rotor 240. The protrusion 246 is arranged to protrude outward from the internal space 245 of the rotor 240. In this embodiment, three protrusions 246 are provided on the outer circumferential surface of the rotor 240 at different positions in the circumferential direction, spaced apart by approximately 120° from each other.

[0055] As shown in FIGS. 2 and 3, the seal member 250 has a generally cylindrical outer shape including a distal end portion 251, a proximal end portion 253, and a side surface portion 254 extending between the distal end portion 251 and the proximal end portion 253.

[0056] The insertion hole 255 of the seal member 250 passes through between a distal end surface 251 a located on the distal end 251 side of the seal member 250 and a proximal end surface 253 a located on the proximal end 253 side of the seal member 250 .

[0057] In the first and second embodiments, the tip surface 251 a of the seal member 250 is disposed so as to abut against a support surface 216 a located on the base portion 216 of the housing member 210 .

[0058] In the first and second embodiments, the base end surface 253 a of the seal member 250 is arranged so as to abut against the tip end surface 261 a of the spacer 260 arranged between the seal member 250 and the rotor 240 .

[0059] The side surface portion 254 of the seal member 250 is surrounded along the outer periphery by the side surface portion 216 b of the base portion 216 .

[0060] As will be described later, when the rotor 240 advances from the retracted position Bp toward the advanced position Fp, a pushing force is applied to the base end surface 253a of the seal member 250 as the rotor 240 advances. When this pushing force is applied to the seal member 250, the seal member 250 is compressed in the longitudinal direction of the seal member 250. Furthermore, when the seal member 250 is compressed as described above, the distal end surface 251a of the seal member 250 is pressed against the support surface 216a of the base portion 216, while the radial expansion deformation of the seal member 250 is limited by the side surface portion 216b of the base portion 216 that surrounds the side surface portion 254 of the seal member 250. Therefore, the hemostasis valve assembly 200 can efficiently apply a force to the seal member 250 that compresses the seal member 250 in the longitudinal direction as the rotor 240 advances from the retracted position Bp toward the advanced position Fp. In this way, the hemostasis valve assembly 200 can quickly close at least a portion of the insertion hole 255 of the seal member 250 by knocking the cap member 220 and moving the rotor 240 forward.

[0061] The sealing member 250 can be made of, for example, a flexible material that can be compressed in the longitudinal direction by the pushing force applied from the rotor 240. The material that makes up the sealing member 250 is, for example, an elastic material, and can be synthetic rubber such as silicone rubber, fluororubber, or urethane rubber, or elastomers such as natural rubber, amide elastomers, styrene elastomers, or olefin elastomers.

[0062] As shown in Figures 4 to 6, 8, and 9, the hemostatic valve assembly 200 is configured so that by knocking the cap member 220, the pushing member 230 moves back and forth, and the rotor 240 rotates in conjunction with the back and forth movement of the pushing member 230, so that the rotor 240 can be engaged at a retracted position Bp (see Figure 2) located inside the housing member 210 and at an advanced position Fp (see Figure 7).

[0063] The above-mentioned "knocking operation" refers to an operation of pushing the base end 223 of the cap member 220 from the base end side toward the tip end side. As will be described later, when the knocking operation is performed, the cap member 220 moves back and forth along the longitudinal direction of the housing member 210 together with the pushing member 230 connected to the cap member 220.

[0064] Furthermore, the above phrase "capable of being locked at the retracted position Bp and the advanced position Fp" means that the position of the rotor 240 can be selectively held at the advanced position Fp or the retracted position Bp in conjunction with the knocking operation of the cap member 220. A specific configuration for locking the rotor 240 will be described later.

[0065] The hemostatic valve assembly 200 is configured to be switchable between a first form in which the space A between the tip surface 241a of the rotor 240 and the base portion 216 when positioned in the retracted position Bp has a first volume V1 and the insertion hole 255 of the sealing member 250 is in an open state, and a second form in which the space A between the tip surface 241a of the rotor 240 and the base portion 216 when positioned in the advanced position Fp has a second volume V2 smaller than the first volume V1 and the sealing member 250 is compressed longitudinally to block at least a portion of the insertion hole 255, thereby forming a closed state.

[0066] The "first configuration in an open state" is the configuration shown in Fig. 2. In the first configuration, the pushing member 230 does not apply a pushing force toward the tip of the rotor 240, and the rotor 240 is located in the retracted position Bp. In this configuration, the rotor 240 does not apply a sufficient pushing force to the seal member 250 to press the seal member 250 against the base portion 216. Therefore, in the first configuration, the seal member 250 maintains the insertion hole 255 in an open state.

[0067] The "second configuration in a closed state" is the configuration shown in FIG. 7 . In the second configuration, the rotor 240 is moved to an advanced position Fp, which is located further toward the distal end than the retracted position Bp, by the pushing force applied from the pushing member 230 toward the distal end. In this configuration, the rotor 240 applies a pushing force that presses the seal member 250 against the base portion 216, causing the seal member 250 to be compressed in the longitudinal direction. By being compressed in the longitudinal direction, the seal member 250 closes at least a portion of the insertion hole 255 of the seal member 250. As a result, in the second configuration, the seal member 250 maintains a state in which the insertion hole 255 is closed (a state in which the blocking portion S is formed).

[0068] 2 , in the first configuration of the hemostasis valve assembly 200, the rotor 240 is located in the retracted position Bp. At this time, the distal end surface 241a of the rotor 240 is positioned at a predetermined first distance from the support surface 216a of the base 216. In the first configuration, the hemostasis valve assembly 200 defines a space A having a first volume V1 corresponding to the first distance between the distal end surface 241a of the rotor 240 and the support surface 216a of the base 216.

[0069] 7 , in the second configuration of the hemostasis valve assembly 200, the rotor 240 is located in the advanced position Fp. At this time, the second distance between the distal end surface 241 a of the rotor 240 and the support surface 216 a of the base 216 is shorter than the first distance, depending on the length (compression amount) of the longitudinally compressed seal member 250. Therefore, in the second configuration, the hemostasis valve assembly 200 defines a space A between the distal end surface 241 a of the rotor 240 and the support surface 216 a of the base 216, the space A having a second volume V2 smaller than the first volume V1.

[0070] As described above, when the cap member 220 is knocked, the pushing member 230 presses the seal member 250 against the base portion 216, compressing the seal member 250 in the longitudinal direction. By compressing the seal member 250 in the longitudinal direction, the hemostasis valve assembly 200 closes at least a portion of the insertion hole 255 of the seal member 250, forming a closed portion S in the insertion hole 255. The hemostasis valve assembly 200 can apply a force to the seal member 250 from the pushing member 230 and the rotor 240, which move toward the distal end in conjunction with the knocking operation of the cap member 220, to press the seal member 250 against the base portion 216 of the housing member 210. At this time, the surgeon, etc., can knock the cap member 220 to advance the pushing member 230, thereby rotating the rotor 240 in conjunction with the advancement of the pushing member 230. Therefore, the hemostasis valve assembly 200 can achieve the operation required to switch from the open state to the closed state simply by knocking the cap member 220. As a result, the hemostasis valve assembly 200 can efficiently compress the seal member 250 in the longitudinal direction while reducing the amount of work required by the surgeon or the like to switch from the open state to the closed state.

[0071] Furthermore, after being switched to the occlusion state, the hemostatic valve assembly 200 can preferably maintain the sealing properties of the occlusion portion S formed in the seal member 250 by engaging the rotor 240 in the forward position Fp.

[0072] Furthermore, the hemostatic valve assembly 200 is configured so that the insertion hole 255 is closed to form an occlusion portion S by compressing the seal member 250 in the longitudinal direction with the pushing member 230. Therefore, when the dilator 300 or a medical device is inserted through the seal member 250 in a state in which the occlusion portion S is formed in the seal member 250 (the occlusion state), the seal member 250 can be deformed so that the occlusion portion S is expanded to match the outer diameter of the dilator 300 or medical device while maintaining close contact between the dilator 300 or medical device and the occlusion portion S. Therefore, when the surgeon operates the pushing member 230 to switch to the occlusion state, the surgeon can smoothly insert the dilator 300 or a medical device through the seal member 250 without impairing the sealing properties of the occlusion portion S formed in the seal member 250.

[0073] 2, 3, and 7, in the medical device 10, the inner cavity 105 of the sheath member 100, the internal space 235 of the pushing member 230, and the internal space 245 of the rotor 240 are arranged coaxially. In other words, the above-mentioned parts 105, 235, and 245 are arranged so that the central positions of the above-mentioned parts 105, 235, and 245 overlap with the central axis c1 in a plan view seen from the base end side of the cap member 220.

[0074] In either the first or second form of the medical device 10, the members 100, 230, 240 are attached to various locations on the housing member 210 so that the above-mentioned sections 105, 235, 245 can be maintained in a coaxial arrangement.

[0075] As described above, in the medical device 10, the inner cavity 105 of the sheath member 100, the internal space 235 of the pushing member 230, and the internal space 245 of the rotor 240 are arranged coaxially. Therefore, the surgeon can smoothly introduce the dilator tube 310 or a medical device, which has been inserted into the housing member 210 from the base end side of the cap member 220 through the opening 225 of the cap member 220, into the inner cavity 105 of the sheath member 100 via the internal space 235 of the pushing member 230 and the internal space 245 of the rotor 240, which are arranged in the through-hole 215 of the housing member 210.

[0076] 2 and 3 , the hemostatic valve assembly 200 includes a spacer 260 disposed between the rotor 240 and the seal member 250. Therefore, in the first and second configurations of the medical device 10, the lumen 105 of the sheath member 100, the internal space 235 of the pushing member 230, the internal space 245 of the rotor 240, and the hole portion 265 of the spacer 260 are arranged coaxially. Furthermore, the opening 225 of the cap member 220, which is the insertion portion for the dilator 300 and the medical device into the through-hole 215 of the housing member 210, is also arranged coaxially with the above-mentioned respective portions 105, 235, 245, 265.

[0077] The opening 225 of the cap member 220 through which the dilator 300 and the medical device are inserted, the internal space 235 of the pushing member 230, the internal space 245 of the rotor 240, the insertion hole 255 of the sealing member 250 in the first form, and the hole 265 of the spacer 260 can each be formed in an approximately circular shape when viewed in a plan view from the base end side of the cap member 220.

[0078] As shown in FIGS. 3 and 4, the pushing member 230 has a first cam groove 231 a formed on the tip surface of the pushing member 230 .

[0079] The first cam groove 231 a is made up of a plurality of concave and convex inclined surfaces formed along the circumferential direction of the tip end surface of the pushing member 230 .

[0080] As shown in FIGS. 3 and 4, the rotor 240 has a protrusion 246 on which a cam surface 246 a that can mesh with the first cam groove 231 a of the pushing member 230 is formed.

[0081] The cam surface 246a is formed on the upper end surface (base end surface) of the convex portion 246. As shown in Fig. 4, in the first mode, the cam surface 246a is disposed so as to face the inclined surface of the first cam groove 231a.

[0082] As shown in FIGS. 3, 4, and 5, the housing member 210 has a second cam groove 218 that is provided on the inner circumferential surface at a position closer to the base end than the base portion 216 and that can mesh with the cam surface 246a.

[0083] The second cam groove 218 has one end 218a located on one side of the rotation direction of the rotor 240, the other end 218b located opposite the one end 218a, a first inclined portion 218c extending diagonally between the one end 218a and the other end 218b, and a second inclined portion 218d extending diagonally toward the other end in the rotation direction beyond the other end 218b.

[0084] 3, the housing member 210 has a plurality of cam portions 217 each having a second cam groove 218. In this embodiment, the housing member 210 has five cam portions 217 arranged at equal intervals from one another in the circumferential direction of the inner circumferential surface of the housing member 210.

[0085] A gap extending linearly along the axial direction is provided between adjacent cam portions 217 in the circumferential direction of housing member 210. This gap forms insertion groove 217a that guides the forward and backward movement of convex portion 236a of pushing member 230. When pushing member 230 moves forward and backward, the movement of convex portion 236a is guided by insertion groove 217a, so pushing member 230 moves linearly forward and backward (up and down) along the axial direction along which insertion groove 217a extends.

[0086] 4 to 6 , when the cap member 220 is knocked in the first mode, the hemostatic valve assembly 200 guides the movement of the convex portion 246 by engaging the first cam groove 231 a of the pushing member 230 with the cam surface 246 a of the convex portion 246 of the rotor 240, thereby guiding the convex portion 246 to a position where the cam surface 246 a engages with the second cam groove 218 of the housing member 210, and then further moving the convex portion 246 along the second cam groove 218 of the housing member 210, thereby positioning the convex portion 246 at an engagement position (other end 218 b) provided in the second cam groove 218. Details of the above operation will be described later.

[0087] As shown in FIGS. 2, 3 and 7, the hemostasis valve assembly 200 includes a spacer 260 located within the housing member 210 and between the rotor 240 and the seal member 250.

[0088] The spacer 260 has a base end surface 263 a that abuts against the tip end surface 241 a of the rotor 240 , and a tip end surface 261 a that abuts against the base end surface 253 a of the seal member 250 .

[0089] The spacer 260 is made of an annular member having an outer diameter that is approximately the same as the outer diameter of the seal member 250 and the outer diameter of the tip end 241 of the rotor 240 .

[0090] The spacer 260 has a hole 265 that penetrates between the distal end surface 261a and the proximal end surface 263a.

[0091] When the rotor 240 rotates, the spacer 260 prevents the rotation of the rotor 240 from being transmitted to the seal member 250. By preventing the rotation of the rotor 240 from being transmitted to the seal member 250 as described above, the hemostasis valve assembly 200 can prevent unwanted deformation, such as twisting, from occurring in the seal member 250 when the rotor 240 advances. Furthermore, when the rotor 240 advances, the rotor 240 can efficiently apply a force (a force perpendicular to the axial direction) to the seal member 250 via the spacer 260, compressing the seal member 250 along the longitudinal direction.

[0092] As described above, spacer 260 is preferably made of a material harder than seal member 250 so as to be able to prevent the rotation of rotor 240 from being transmitted to seal member 250. When seal member 250 is made of the above-mentioned material, spacer 260 can be made of, for example, a fluororesin such as polytetrafluoroethylene (PTFE), an epoxy resin, an acetal resin, an amide resin, or a polyether ether ketone resin (PEEK).

[0093] As shown in FIGS. 10 and 11, the housing member 210 has a window 219 that allows a portion of the rotor 240 to be seen from the outside when in the closed state (second configuration).

[0094] The window portion 219 can be configured, for example, as a transparent (including colored transparent and semi-transparent) portion (area) through which the inside of the housing member 210 can be seen from the outside of the housing member 210 .

[0095] As shown in Fig. 10 , the window portion 219 can be provided at a position that allows the spacer 260 to be viewed from outside the housing member 210 in the open state (first form), for example. As described above, in the open state of the hemostasis valve assembly 200, the rotor 240 is located at the retracted position Bp. Therefore, in the open state, the housing member 210 allows the spacer 260 located on the distal side of the rotor 240 to be viewed from outside through the window portion 219, while in the closed state as shown in Fig. 11 , a portion of the rotor 240 that has moved to the advanced position Fp, which is located distal to the retracted position Bp, can be viewed.

[0096] As described above, the hemostatic valve assembly 200 is configured so that at least a portion of the rotor 240 can be seen through the window portion 219 in the blocked state (second form), so that the surgeon or other personnel can easily visually confirm whether the insertion hole 255 of the sealing member 250 is in an open state or a blocked state.

[0097] When the rotor 240 and the spacer 260 are made visible through the window 219 as described above, it is preferable to color the rotor 240 and the spacer 260 in a predetermined color in order to more clearly distinguish between the open state and the closed state. When the rotor 240 and the spacer 260 are colored, it is preferable to color the rotor 240 and the spacer 260 in different colors.

[0098] Next, referring to Figures 2 and 4 to 9, the operation of the hemostatic valve assembly 200 when switching between an open state (first form) and a closed state (second form) in conjunction with a knock operation of the cap member 220 will be described.

[0099] 4 shows the state when a knocking operation is initiated to push down the cap member 220 toward the tip end in the open state. In the open state, the rotor 240 is located at the retracted position Bp, and the seal member 250 maintains the insertion hole 255 open (see FIG. 2).

[0100] When switching the hemostasis valve assembly 200 from the open state to the closed state, the surgeon performs a knocking operation to push down the cap member 220 toward the distal end. When the surgeon performs a knocking operation to push down the cap member 220, the pushing member 230 connected to the cap member 220 advances toward the distal end.

[0101] When pushing member 230 advances toward the tip side, first cam groove 231a formed on the tip surface of pushing member 230 abuts against cam surface 246a of convex portion 246 of rotor 240. When pushing member 230 advances toward the tip side with cam surface 246a abutting against first cam groove 231a as described above, rotor 240 causes cam surface 246a of convex portion 246 to slide along first cam groove 231a while moving toward the tip side.

[0102] As shown in Figure 5, when the pushing member 230 advances a predetermined distance toward the tip side, it moves the rotor 240 to a position where the cam surface 246a of the convex portion 246 of the rotor 240 engages with the second cam groove 218 provided on the inner surface of the housing member 210.

[0103] When the cam surface 246a of the convex portion 246 of the rotor 240 is guided to one end 218a of the second cam groove 218 by the first cam groove 231a of the pushing member 230, the convex portion 246 is caused to slide along the first inclined portion 218c of the second cam groove 218. The cam surface 246a of the convex portion 246 slides along the first inclined portion 218c of the second cam groove 218, causing the rotor 240 to rotate in the circumferential direction about the central axis c1.

[0104] 6 , the protrusion 246 of the rotor 240 slides along the first inclined portion 218c of the second cam groove 218 and is guided to the other end 218b of the second cam groove 218. A vertical wall portion extending along the axial direction is connected to the other end 218b of the second cam groove 218. Therefore, when the protrusion 246 of the rotor 240 is guided to the other end 218b of the second cam groove 218, it abuts against the vertical wall portion, thereby restricting further movement.

[0105] When the protrusion 246 of the rotor 240 moves to the other end 218b, the rotor 240 enters a locked state in which the protrusion 246 is engaged at the position of the other end 218b. Once the rotor 240 is in the locked state, it cannot rotate or move back and forth unless the cap member 220 is knocked. In this state, the rotor 240 has moved to the forward position Fp, and the seal member 250 disposed at the distal end of the rotor 240 is pressed against the base portion 216, maintaining the seal member 250 in a longitudinally compressed state. As a result, as shown in FIG. 7 , the hemostasis valve assembly 200 maintains a closed state in which a blocking portion S is formed that blocks the insertion hole 255 of the seal member 250.

[0106] When switching the hemostasis valve assembly 200 from the closed state to the open state, the surgeon performs a knocking operation to push down the cap member 220 toward the distal end, as shown in Fig. 8 . When the surgeon performs the knocking operation on the cap member 220, the pushing member 230 connected to the cap member 220 moves toward the distal end. As the pushing member 230 moves toward the distal end, the first cam groove 231a formed on the distal end surface of the pushing member 230 again engages with the convex portion 246 of the rotor 240. While still engaged with the first cam groove 231a of the pushing member 230, the convex portion 246 of the rotor 240 advances toward the distal end as the pushing member 230 advances toward the distal end.

[0107] As described above, the rotor 240 moves a predetermined distance toward the tip as the pushing member 230 advances toward the tip, and advances to a position where the engagement of the convex portion 246 with the other end 218b, which is the engagement position of the second cam groove 218 of the housing member 210, is released. When the rotor 240 advances to this position, the sliding movement of the convex portion 246 along the second inclined portion 218d of the second cam groove 218 begins, as shown in FIG. 9 .

[0108] When the convex portion 246 of the rotor 240 moves along the second inclined portion 218d of the second cam groove 218 and is guided to the insertion groove 217a adjacent to the second inclined portion 218d, the rotor 240 is returned to the retracted position Bp, which is the original position before compressing the seal member 250. As a result, the rotor 240 is located at the retracted position Bp, and the hemostasis valve assembly 200 is switched to a state (open state) in which it is not compressed in the longitudinal direction.

[0109] As described above, the surgeon can easily and smoothly switch the seal member 250 between the open state and the closed state each time he or she performs the knocking operation of pressing down the cap member 220 .

[0110] As shown in FIG. 1 , the housing member 210 has a first port portion 271 and a second port portion 272 .

[0111] Each port portion 271 , 272 is arranged to communicate with the through-hole 215 of the housing member 210 in a tip region 215 a located on the tip side of the base portion 216 of the housing member 210 .

[0112] As shown in FIG. 1, the first port portion 271 can be connected to a tube 275 a connected to a three-way stopcock 277 for supplying a liquid such as physiological saline into the housing member 210 .

[0113] 1, a suction device can be connected to the second port 272 via a predetermined tube 275b. The suction device can be used when performing a procedure to aspirate a blood clot or the like in a vein. Note that the installation of the second port 272 can be omitted as appropriate depending on the intended use of the medical device 10, etc.

[0114] <Dilator 300> As shown in FIG. 1, the dilator 300 includes a dilator tube 310 and a dilator hub 320.

[0115] The dilator 300 can detachably fix the dilator hub 320 to the cap member 220 with the dilator tube 310 inserted through the hemostatic valve assembly 200 and the inner cavity 105 of the sheath member 100.

[0116] With the dilator 300 assembled to the medical device 10, the surgeon inserts the sheath member 100 into a perforation formed in the living body that connects the living body lumen into which the sheath member 100 is to be inserted and the outside of the living body, and pushes open the perforation. The dilator 300 prevents the sheath member 100 from being bent or otherwise damaged when the sheath member 100 is inserted into the living body lumen through the perforation as described above.

[0117] Prior to inserting the sheath member 100 together with the dilator 300 into the biological lumen as described above, the surgeon passes a guide wire, which is disposed between the biological lumen and the outside of the living body, through the dilator tube 310 via a perforation formed in the living body, and inserts the dilator 300 and sheath member 100 into the biological lumen along the guide wire. After inserting the distal end of the dilator 300 to a desired position in the biological lumen, the surgeon removes the dilator tube 310 from the sheath member 100. The surgeon can use the lumen 105 of the sheath member 100, from which the dilator tube 310 has been removed, as an access route to deliver a medical device to a desired position in the biological lumen.

[0118] When using the medical instrument 10 according to this embodiment, the dilator tube 310 or a medical device to be inserted into a biological lumen can be inserted through the seal member 250 in a state in which a blocking portion S is formed in the insertion hole 255 of the seal member 250 (blocked state) as shown in Fig. 7. The seal member 250 comes into close contact with the outer peripheral surface of the dilator tube 310 or medical device that has been pushed into the blocking portion S, thereby preventing blood or liquid such as physiological saline injected into the housing member 210 from flowing back toward the base end of the cap member 220.

[0119] As described above, the medical device 10 according to this embodiment includes the tubular sheath member 100 and the hemostatic valve assembly 200 connected to the proximal end 103 of the sheath member 100. The hemostatic valve assembly 200 includes a housing member 210 having a through-hole 215 extending from the distal end 211 toward the proximal end 213 and a seat portion 216 located midway along the through-hole 215, and an opening 225 protruding from the proximal end 213 of the housing member 210 and communicating with the through-hole 215. a tubular pushing member 230 connected to the cap member 220 and protruding along the through-hole 215 while having an internal space 235 communicating with the opening 225; a tubular rotor 240 disposed within the housing member 210 and having an internal space 245 communicating with the internal space 235 of the pushing member 230 at the tip side of the pushing member 230; and a tubular rotor 240 located on the tip side of the rotor 240 and disposed in the base portion 216 and having an internal space 245 communicating with the internal space 235 of the pushing member 230. and a seal member 250 having a communicating insertion hole 255. The hemostasis valve assembly 200 is configured such that, by knocking the cap member 220, the pushing member 230 is moved back and forth, and the rotor 240 is rotated in accordance with the back and forth movement of the pushing member 230, so that the rotor 240 can be locked at an advanced position Fp located inside the housing member 210 and a retracted position Bp. The hemostasis valve assembly 200 is configured such that the rotor 240 located in the advanced position Fp can be locked at an advanced position Bp. The rotor 240 is configured to be switchable between a first form in which the space A between the tip surface 241a and the base portion 216 has a first volume V1 and the insertion hole 255 of the sealing member 250 is in an open state, and a second form in which the space A between the tip surface 241a of the rotor 240 located in the retracted position Bp and the base portion 216 has a second volume V2 smaller than the first volume V1 and the sealing member 250 is compressed in the longitudinal direction and the insertion hole 255 is in a closed state.

[0120] The hemostasis valve assembly 200 configured as described above is configured so that knocking the cap member 220 moves the pushing member 230 back and forth, rotating the rotor 240 in accordance with the back and forth movement, thereby locking the rotor 240 at an advanced position Fp or a retracted position Bp located inside the housing member 210. The hemostasis valve assembly 200 is also configured to be switchable between a first form in which the space A between the distal end surface 241 a of the rotor 240 and the base portion 216 at the advanced position Fp has a first volume V1 and the insertion hole 255 of the seal member 250 is in an open state, and a second form in which the space A between the distal end surface 241 a of the rotor 240 and the base portion 216 at the retracted position Bp has a second volume V2 smaller than the first volume V1 and the seal member 250 is in a closed state in which it is compressed in the longitudinal direction and at least a portion of the insertion hole 255 is closed. In the hemostasis valve assembly 200 configured as described above, when the cap member 220 is knocked, the pushing member 230 moves toward the distal end, rotating the rotor 240 within the housing member 210 and advancing the rotor 240 toward the distal end, thereby pressing the seal member 250, which is disposed on the distal side of the pushing member 230, against the base portion 216 of the housing member 210. By pressing the seal member 250 against the base portion 216 with the pushing member 230 as described above, the hemostasis valve assembly 200 compresses the seal member 250 in the longitudinal direction. Then, by compressing the seal member 250 in the longitudinal direction, the hemostasis valve assembly 200 can form an occlusion portion S in the seal member 250, in which the insertion hole 255 is closed. The hemostasis valve assembly 200 can efficiently compress the seal member 250 in the longitudinal direction by applying a force from the rotor 240, which moves toward the distal end as the pushing member 230 advances, to the seal member 250, pressing the seal member 250 against the base portion 216 of the housing member 210. Furthermore, after being switched to the occluded state, the hemostasis valve assembly 200 can preferably maintain the sealing properties of the occlusion portion S formed in the seal member 250 by locking the rotor 240 at the advanced position Fp.

[0121] Furthermore, since the hemostatic valve assembly 200 is configured to form an occlusion portion S in which the insertion hole 255 is closed by compressing the seal member 250 in the longitudinal direction with the pushing member 230 as described above, when the dilator 300 or a medical device is inserted through the seal member 250 in a state in which the occlusion portion S is formed in the seal member 250 (the closed state), the seal member 250 can be deformed so that the occlusion portion S is expanded to match the outer diameter of the dilator 300 or medical device while maintaining close contact between the dilator 300 or medical device and the occlusion portion S. Therefore, when the surgeon operates the pushing member 230 to switch to the closed state, the surgeon can smoothly insert the dilator 300 or a medical device through the seal member 250 without impairing the sealing properties of the occlusion portion S formed in the seal member 250.

[0122] As described above, according to this embodiment, a medical device 10 can be provided in which the hemostatic valve assembly 200 can be selectively switched between an open state and a closed state with a simple operation, and which allows the dilator 300 and medical devices to be smoothly inserted even in the closed state.

[0123] In addition, in the medical device 10, the inner cavity 105 of the sheath member 100, the internal space 235 of the pushing member 230, and the internal space 245 of the rotor 240 are arranged coaxially.

[0124] As described above, in the medical device 10, the inner cavity 105 of the sheath member 100, the internal space 235 of the pushing member 230, and the internal space 245 of the rotor 240 are arranged coaxially. Therefore, the surgeon can smoothly introduce the dilator tube 310 or a medical device that has been inserted into the housing member 210 from the base end side of the cap member 220 through the opening 225 of the cap member 220 into the inner cavity 105 of the sheath member 100 via the internal space 235 of the pushing member 230 and the internal space 245 of the rotor 240 that are arranged in the through-hole 215 of the housing member 210.

[0125] Furthermore, the pushing member 230 has a first cam groove 231 a formed on the distal end surface of the pushing member 230, the rotor 240 has a convex portion 246 formed with a cam surface 246 a that can mesh with the first cam groove 231 a of the pushing member 230, the housing member 210 has a second cam groove 218 that is provided on the inner circumferential surface at a position closer to the base end than the pedestal portion 216 and that can mesh with the cam surface 246 a, and the hemostasis valve assembly 200 is configured such that, when the cap member 220 is knocked in the first mode, When this is done, the first cam groove 231a of the pushing member 230 and the cam surface 246a of the convex portion 246 of the rotor 240 are engaged with each other while guiding the movement of the convex portion 246, thereby guiding the convex portion 246 to a position where the cam surface 246a engages with the second cam groove 218 of the housing member 210, and by further moving the convex portion 246 along the second cam groove 218 of the housing member 210, the convex portion 246 is positioned at the engagement position (other end 218b) provided in the second cam groove 218.

[0126] The hemostasis valve assembly 200 has the first cam groove 231a of the pushing member 230, the cam surface 246a of the convex portion 246 of the rotor 240, and the second cam groove 218 of the housing member 210, which are configured as described above, and therefore can easily and smoothly switch between the open state and the closed state each time the cap member 220 is knocked. Furthermore, by knocking the cap member 220, the hemostasis valve assembly 200 can position the convex portion 246 at the locking position (other end 218b) provided in the second cam groove 218, thereby preventing the closed state from being inadvertently released.

[0127] The hemostasis valve assembly 200 also includes a spacer 260 located within the housing member 210 and between the rotor 240 and the seal member 250 .

[0128] The hemostasis valve assembly 200 includes the spacer 260, which prevents the rotation of the rotor 240 from being transmitted to the seal member 250 when the rotor 240 rotates. By preventing the rotation of the rotor 240 from being transmitted to the seal member 250, the hemostasis valve assembly 200 can prevent unwanted deformation, such as twisting, of the seal member 250 when the rotor 240 advances. Furthermore, when the rotor 240 advances, the rotor 240 can efficiently apply a force (a vertical force along the axial direction) that compresses the seal member 250 along the longitudinal direction to the seal member 250 via the spacer 260. Therefore, the hemostasis valve assembly 200 can quickly close the insertion hole 255 of the seal member 250 as the rotor 240 advances. This allows the medical device 10 to reduce the force required when an operator switches from an open state to a closed state (the force required when an operator performs a knocking operation), further improving the operability of the hemostatic valve assembly 200.

[0129] The housing member 210 also has a window 219 that allows a portion of the rotor 240 to be seen from the outside when in the closed state (second configuration).

[0130] As described above, the hemostatic valve assembly 200 includes a housing member 210 configured so that in the closed state (second form), at least a portion of the rotor 240 can be seen through the window 219. This allows the surgeon or other person to easily visually check whether the insertion hole 255 of the seal member 250 is in an open state or in a closed state (a state in which the closed portion S is formed).

[0131] The medical device according to the present invention has been described above through the embodiments, but the present invention is not limited to the content described in this specification and can be modified as appropriate based on the description of the claims.

[0132] The structure of each part and the arrangement of components described in the specification may be changed as appropriate, and the use of additional components described in the drawings may be omitted or other additional components may be used as appropriate.

[0133] This application is based on Japanese Patent Application No. 2024-86074, filed on May 28, 2024, the disclosure of which is incorporated herein by reference in its entirety.

[0134] 1 Introducer kit 10 Medical device 100 Sheath member 101 Distal end of sheath member 103 Proximal end of sheath member 105 Lumen 200 Hemostatic valve assembly 210 Housing member 211 Distal end of housing member 213 Proximal end of housing member 215 Through hole 216 Base portion 217 Cam portion 217a Insertion groove 218 Second cam groove 218a One end of second cam groove 218b Other end of second cam groove 218c First inclined portion of second cam groove 218d Second inclined portion of second cam groove 219 Window portion 220 Cap member 221 Distal end of cap member 223 Proximal end of cap member 225 Opening of cap member 230 Pushing member 231 Distal end of pushing member 231a First cam groove 233 Proximal end of pushing member 235 Internal space of pushing member 240 Rotor 241 Distal end of rotor 241a Distal end surface of rotor 243 Proximal end of rotor 245 Internal space of rotor 246 Convex portion 246a Cam surface 250 Seal member 251 Distal end of seal member 251a Distal end surface of seal member 253 Proximal end of seal member 253a Proximal end surface of seal member 254 Side portion of seal member 255 Insertion hole 260 Spacer 261a Distal end surface of spacer 263a Proximal end surface of spacer 265 Hole portion 271 First port portion 272 Second port portion 300 Dilator A Space Bp Retracted position Fp Advanced position S Blocking portion c1 Central axis of sheath member

Claims

1. A device comprising: a tubular sheath member; and a hemostatic valve assembly connected to a proximal end of the sheath member, wherein the hemostatic valve assembly comprises: a housing member having a through hole extending from the distal end to the proximal end and a base portion located midway along the through hole; a cap member protruding from the proximal end of the housing member and having an opening communicating with the through hole; a tubular pushing member connected to the cap member, protruding along the through hole and having an internal space communicating with the opening; a tubular rotor disposed within the housing member and having an internal space communicating with the internal space of the pushing member on the distal side of the pushing member; and a seal member located distal to the rotor, disposed in the base portion, and having an insertion hole communicating with the through hole. The hemostatic valve assembly is configured so that the rotor can be engaged in a retracted position located inside the housing member and an advanced position by knocking the cap member to move the pushing member back and forth and rotate the rotor in conjunction with the back and forth movement, and the hemostatic valve assembly is configured so that it can be switched between a first form in which the space between the tip surface of the rotor located in the retracted position and the base portion has a first volume and the insertion hole of the sealing member is in an open state, and a second form in which the space between the tip surface of the rotor located in the advanced position and the base portion has a second volume smaller than the first volume and the sealing member is compressed in the longitudinal direction to block at least a portion of the insertion hole.

2. The medical device according to claim 1, wherein the inner cavity of the sheath member, the internal space of the pushing member, and the internal space of the rotor are arranged coaxially.

3. The medical device of claim 1, wherein the pushing member has a first cam groove formed on its distal end surface, the rotor has a convex portion formed with a cam surface that can engage with the first cam groove, the housing member has a second cam groove provided on its inner surface at a position closer to the base end than the base portion and that can engage with the cam surface, and the hemostatic valve assembly, when the cap member is knocked in the first form, guides the movement of the convex portion while engaging the first cam groove with the cam surface, thereby guiding the convex portion to a position where the cam surface engages with the second cam groove, and further moves the convex portion along the second cam groove to position the convex portion at an engagement position provided in the second cam groove.

4. The medical device of claim 1, wherein the hemostatic valve assembly has a spacer positioned inside the housing member, between the rotor and the seal member, the spacer having a base end surface that abuts against the distal end surface of the rotor and a distal end surface that abuts against the proximal end surface of the seal member.

5. The medical device according to claim 1, wherein the housing member has a window that allows a portion of the rotor to be viewed from the outside in the second configuration.

Images