Medical instrument

Abstract

[Problem] To provide a medical instrument which enables selective switching of a hemostatic valve assembly between an open state and a closed state by means of a simple operation, and which makes it possible to smoothly insert a dilator or a medical device even in the closed state. [Solution] A housing member 210 of a hemostatic valve assembly 200 comprises: a cylindrical region 215d that is positioned closer to the distal end side than a push-in member 220; and an inclined region 215c that continuously extends from the distal end of the cylindrical region toward the distal end side, and that has a first through hole 217 having a diameter which decreases from the base end toward the distal end. The push-in member is configured to be movable between a first position P1 at which the base end portion 233 of a seal member 230 is positioned in the cylindrical region, and a second position P2 which is positioned closer to the distal end side of the cylindrical region in comparison to the first position and at which at least a portion of the distal end portion 231 of the seal member is pushed into the inclined region. The diameter of an insertion hole 237 of the seal member decreases from the base end surface 233a toward the distal end surface 231a, and the inclination angle θ1 of the inclined region is more obtuse than the inclination angle θ2 of the insertion hole.

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 and the like 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 with the valve body closed in this manner, the valve body, which is composed of the above-described deformable, flexible bag, 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 (7).

[0016] (1) A hemostatic valve assembly 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 first through hole extending from a distal end toward a proximal end; a pushing member configured to be movable along the housing member and having a second through hole extending from the distal end toward the proximal end; and a seal member located distally of the pushing member and having an insertion hole communicating with the first through hole and the second through hole, wherein the housing member has a cylindrical region located distally of the pushing member and a sloped region extending continuously from the distal end of the cylindrical region toward the distal end, the diameter of the first through hole decreasing from the proximal end toward the distal end, and the pushing member configured to be movable between a first position where the proximal end of the seal member is located in the cylindrical region and a second position where the pushing member is located distally of the cylindrical region relative to the first position and at least a part of the distal end of the seal member is pushed into the sloped region, The medical device, wherein the insertion hole of the sealing member decreases in diameter from a base end surface toward a tip end surface, and an inclination angle of the inclined region is more obtuse than an inclination angle of the insertion hole.

[0017] (2) The medical device according to (1), wherein the pushing member has a distal end surface that abuts against the proximal end surface, and the proximal end surface and the distal end surface have cross-sectional shapes that are approximately parallel to each other.

[0018] (3) The medical device according to (1) or (2), wherein the second through hole has a diameter that decreases from the base end surface of the pushing member toward the tip end surface, and the diameter of the tip end of the second through hole is approximately the same as or equal to the diameter of the base end of the insertion hole.

[0019] (4) The medical device according to any one of (1) to (3), wherein a diameter of a tip of the insertion hole when the pushing member is located at the first position is smaller than a diameter of a tip of the second through hole, and the insertion hole is located closer to the central axis of the sheath member than the tip of the second through hole.

[0020] (5) The medical device according to any one of (1) to (4), wherein a length of the inclined region along the longitudinal direction of the housing member is greater than a thickness of the seal member along the longitudinal direction of the housing member when the pushing member is located at the first position.

[0021] (6) The medical device according to any one of (1) to (5), wherein the housing member has a guide groove that guides movement of the pushing member between the first position and the second position, and the pushing member has an arm portion that is held in the guide groove and is movable along the guide groove.

[0022] (7) The medical device according to any one of (1) to (6), further comprising a cap member connected to the base end of the housing member and having an opening formed therein, wherein the pushing member is disposed on the distal side of the cap member when the pushing member is located at the first position.

[0023] The hemostatic valve assembly of the medical device of the present invention includes a housing member having a first through hole, a pushing member having a second through hole extending from the distal end to the proximal end, and a sealing member having an insertion hole communicating with the first through hole and the second through hole. The hemostatic valve assembly is configured to be selectively switchable between an open state in which the first through hole, the second through hole, and the insertion hole are all connected, and a closed state in which the second through hole of the sealing member is closed by compressive deformation of the sealing member. When the pushing member is moved from the first position to the second position, the pushing member applies a pushing force from the proximal end to the distal end to the sealing member. When the sealing member is pushed toward the distal end as the pushing member moves, the distal end of the sealing member is pressed against the inclined region. As a result, the sealing member compresses and deforms the distal end portion located near the distal surface of the insertion hole. Furthermore, in the hemostatic valve assembly, the inclination angle of the inclined region of the housing member is more obtuse than the inclination angle of the insertion hole of the sealing member, so that the inner diameter of the insertion hole tapers more steeply toward the distal end than the inner diameter of the inclined region of the housing member. Therefore, when the distal end of the sealing member is pressed against the inclined region, the hemostatic valve assembly can be deformed to narrow the vicinity of the distal surface of the insertion hole. By deforming the distal end of the sealing member to narrow the vicinity of the distal surface of the insertion hole, the hemostatic valve assembly can form an occlusion portion at the distal end of the hemostatic valve assembly. The hemostatic valve assembly can exhibit high sealing performance due to the occlusion portion formed at the distal end of the sealing member. Furthermore, the hemostatic valve assembly is configured to form an occlusion portion that occludes the insertion hole by compressing and deforming the distal end of the sealing member with a pushing member. Therefore, when a dilator or medical device is inserted into the sealing member with the occlusion portion formed, the seal member can be deformed to expand the occlusion portion to match the outer diameter of the dilator or various medical devices while maintaining close contact between the dilator or medical device and the occlusion portion. 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 sealing member without impairing the sealing properties of the closed portion formed in the sealing member.As described above, the medical device allows the hemostatic valve assembly to be selectively switched between an open state and a closed state with a simple operation, and also allows a dilator or medical device to be smoothly inserted even in the closed state.

[0024] FIG. 1 is a diagram showing an introducer circuit according to an embodiment. FIG. 2 is a cross-sectional view of a hemostatic valve assembly of a medical device (sheath introducer) according to an embodiment. FIG. 3 is a cross-sectional view for explaining the dimensions of each part of the hemostatic valve assembly. FIG. 4 is a cross-sectional view for explaining the operation of the hemostatic valve assembly. FIG. 5 is a cross-sectional view for explaining the operation of the hemostatic valve assembly. FIG. 6 is a cross-sectional view for explaining the operation of the hemostatic valve assembly. FIG. 7 is a cross-sectional view for explaining the operation of the hemostatic valve assembly. FIG. 8 is a cross-sectional view for explaining the operation of the hemostatic valve assembly. FIG. 9 is a perspective view of the exterior of a housing member. FIG. 10 is a perspective view for explaining an example of an operation when moving a pushing member from a first position to a second position. FIG. 11 is a perspective view for explaining an example of an operation when moving a pushing member from the first position to a second position. FIG. 12 is a perspective view of a hemostatic valve assembly according to a modified example. FIG. 13 is a partial cross-sectional view of a hemostatic valve assembly according to a modified example. FIG. 14 is a view showing a seal member according to modified example 1. FIG. 15 is a view showing a seal member according to modified example 2.

[0025] (Embodiment) Hereinafter, a medical device 10 according to an embodiment will be described with reference to Figs.

[0026] FIG. 1 is a diagram schematically illustrating the overall configuration of the introducer circuit 1. FIG. 2 is a partial cross-sectional view of the hemostatic valve assembly 200 in the direction indicated by arrow 2A-2A in FIG. 1. FIG. 3 is a diagram illustrating the dimensions of each part of the hemostatic valve assembly 200. FIGS. 4 to 8 are diagrams illustrating the operation of the hemostatic valve assembly 200 (the operation of the pushing member 220 and the operation of the sealing member 230). FIGS. 9 to 11 are perspective views illustrating guide grooves 218, 219 provided in the housing member 210. Note that FIGS. 3 to 11 are simplified views in which some of the components of the hemostatic valve assembly 200 are omitted.

[0027] 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.

[0028] <Introducer Circuit 1 > As shown in FIG. 1 , the introducer circuit 1 includes a medical device 10 and a dilator 300 .

[0029] <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.

[0030] 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.

[0031] In the description of this specification, the direction in which the sheath member 100 extends is referred to as the "axial direction" (a direction parallel to the central axis c1 of the sheath member 100; the longitudinal direction of the housing member 210 is also a similar 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.

[0032] <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 first through-hole 217 of the housing member 210.

[0033] The proximal end 103 of the sheath member 100 is disposed at a position closer to the distal end than the ports 251, 252 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 first through-hole 217 of the housing member 210.

[0034] The sheath member 100 has an inner lumen 105 that extends continuously between the distal opening 101a and the proximal opening 103a.

[0035] 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.

[0036] <Hemostatic valve assembly 200> As shown in Figures 2 and 3, the hemostatic valve assembly 200 comprises a housing member 210 having a first through hole 217 extending from the tip 211 to the base end 213, a pushing member 220 configured to be movable along the housing member 210 and having a second through hole 227 extending from the tip to the base end, and a sealing member 230 located further tip than the pushing member 220 and having an insertion hole 237 communicating with the first through hole 217 and the second through hole 227.

[0037] As shown in Figures 2 and 3, the housing member 210 has a cylindrical region 215d located closer to the tip than the pushing member 220, an inclined region 215c that extends continuously from the tip of the cylindrical region 215d toward the tip side and in which the diameter of the first through hole 217 decreases from the base end toward the tip, a tip region 215a located on the tip side of the inclined region 215c, and a base region 215b located on the base end side of the cylindrical region 215d.

[0038] A cap member 240 having an opening 241 is connected to the base end 213 of the housing member 210. In this embodiment, the cap member 240 is fixed to the housing member 210 by screws so as to prevent axial movement. There are no particular limitations on the method for fixing the cap member 240 to the housing member 210.

[0039] As shown in FIG. 2, in this embodiment, the pushing member 220 is located on the distal side of the cap member 240 when the pushing member 220 is located at the first position P1.

[0040] A dilator hub 320 provided on the dilator 300 can be detachably fixed to the cap member 240.

[0041] 2 , the opening 241 of the cap member 240 is arranged to communicate with the first through-hole 217 of the housing member 210. Therefore, when the pushing member 220 is located at the first position P1, the opening 241 of the cap member 240, the first through-hole 217 of the housing member 210, the second through-hole 227 of the pushing member 220, and the insertion hole 237 of the sealing member 230 are in communication with each other.

[0042] The opening 241 of the cap member 240, the first through hole 217 of the housing member 210, the second through hole 227 of the pushing member 220, and the insertion hole 237 of the sealing member 230 are configured to have an approximately circular planar shape when viewed in a plane from the base end side of the cap member 240.

[0043] 9 to 11, the housing member 210 has a base end opening 216 for connecting the pushing member 220 to the housing member 210, insertion grooves 216a and 216b extending from the base end opening 216 toward the tip 211, and guide grooves 218 and 219 (see FIGS. 9 to 11) that guide the movement of the pushing member 220 relative to the housing member 210. Details of the guide grooves 218 and 219 will be described later.

[0044] As shown in Figures 2 and 4 to 6, the pushing member 220 is configured to be movable between a first position P1 where the base end 233 of the sealing member 230 is located in the cylindrical region 215d, and a second position P2 where the second position P2 is located closer to the tip of the cylindrical region 215d than the first position P1, and where at least a portion of the tip end 231 of the sealing member 230 is pushed into the inclined region 215c.

[0045] In this specification, the state in which the pushing member 220 is located at the first position P1 and no blocking portion S is formed at the tip 231 of the sealing member 230 is referred to as the "open state" (the state shown in Figures 2, 4, and 8), and the state in which the pushing member 220 moves to the second position P2 and a blocking portion S is formed at the tip 231 of the sealing member 230 is referred to as the "blocked state" (the state shown in Figures 5 and 6).

[0046] As shown in Figures 2, 10, and 11, the pushing member 220 has a main body portion 221 in which a second through hole 227 is formed, a plurality of arm portions 224a, 224b extending from the main body portion 221 and inserted into each guide groove 218, 219 of the housing member 210, an outer periphery portion 223 connected to each arm portion 224a, 224b and positioned outside the housing member 210, and a finger hook portion 228 connected to the outer periphery portion 223.

[0047] As shown in FIGS. 9 to 11, the pushing member 220 is connected to the housing member 210 via the arm portions 224 a and 224 b and the guide grooves 218 and 219 .

[0048] When connecting the pushing member 220 to the housing member 210, the first arm portion 224a of the pushing member 220 is inserted into the insertion groove 216a of the housing member 210 from the base end 213 side of the housing member 210 (see FIG. 9 ). The second arm portion 224b of the pushing member 220 is inserted into the insertion groove 216b of the housing member 210 from the base end 213 side of the housing member 210. After being inserted into the insertion grooves 216a, 216b, the arm portions 224a, 224b are held in the guide grooves 218, 219 that communicate with the insertion grooves 216a, 216b. With the arm portions 224a, 224b held in the guide grooves 218, 219, the outer periphery 223 of the pushing member 220 is positioned to cover a portion of the outer periphery of the housing member 210.

[0049] As shown in Figure 10, the pushing member 220 is positioned at the first position P1 with the first arm portion 224a positioned at one end 218a of the first guide groove 218 and the second arm portion 224b positioned at one end 219a of the second guide groove 219.

[0050] As will be described later, when each arm portion 224a, 224b moves from one end 218a, 219a of each guide groove 218, 219 toward the other end 218b, 219b, the pushing member 220 moves to a second position P2 (see Figure 11).

[0051] As shown in FIG. 2, the main body 221 of the pushing member 220 has a distal end surface 221a that abuts against the proximal end surface 233a of the sealing member 230, and a proximal end surface 221b located at the proximal end.

[0052] 2 and 4 , when the seal member 230 is located at a first position P1 before the occlusion portion S is formed, the pushing member 220 abuts the distal end surface 221a of the main body portion 221 against the proximal end surface 233a of the seal member 230. Therefore, when the hemostasis valve assembly 200 is switched from the open state to the occlusion state, the pushing member 220 can be moved from the first position P1 to the second position P2 with the distal end surface 221a of the main body portion 221 of the pushing member 220 abutting against the proximal end surface 233a of the seal member 230. As a result, when the pushing member 220 moves from the first position P1 to the second position P2, the hemostasis valve assembly 200 can efficiently transmit the pushing force from the pushing member 220 to the seal member 230, thereby smoothly switching from the open state to the occlusion state.

[0053] 2, the proximal end surface 233a of the sealing member 230 and the distal end surface 221a of the main body 221 of the pushing member 220 have substantially parallel cross-sectional shapes. In this embodiment, the proximal end surface 233a and the distal end surface 221a each extend in a direction substantially perpendicular to the central axis c1 in the cross section shown in FIG.

[0054] As described above, in the hemostasis valve assembly 200, the proximal surface 233a of the seal member 230 and the distal surface 221a of the main body 221 of the pushing member 220 have cross-sectional shapes that are substantially parallel. Therefore, when the pushing member 220 is moved from the first position P1 to the second position P2, a pushing force toward the distal end can be efficiently applied from the distal surface 221a of the main body 221 of the pushing member 220 to the proximal surface 233a of the seal member 230. Furthermore, when the pushing member 220 is moved from the first position P1 to the second position P2, the seal member 230 can be pushed toward the distal end of the hemostasis valve assembly 200 along the central axis c1. Therefore, when the pushing member 220 is moved from the first position P1 to the second position P2, tilting of the seal member 230 and the insertion hole 237 is suppressed, and a blocking portion S can be reliably formed at the distal end 231 of the seal member 230.

[0055] The second through-hole 227 of the pushing member 220 passes through between the base end surface 221 b of the main body portion 221 and the tip end surface 221 a of the main body portion 221 .

[0056] As shown in FIG. 2, the seal member 230 has a distal portion 231 located near a distal surface 231a, a proximal portion 233 located near a proximal surface 233a, and an intermediate portion 235 located between the distal portion 231 and the proximal portion 233.

[0057] The sealing member 230 can be configured to have a cylindrical outer shape when the pushing member 220 is in the first position P1 (open state).

[0058] As shown in FIGS. 2 and 3, the insertion hole 237 of the seal member 230 decreases in diameter from the base end surface 233a toward the tip end surface 231a.

[0059] As shown in FIGS. 2 and 3, the inclination angle θ1 of the inclined region 215c of the housing member 210 is more obtuse than the inclination angle θ2 of the insertion hole 237.

[0060] The inclination angle θ1 of the inclined region 215c can be defined as the angle between an imaginary line A1 parallel to the central axis c1 and a line along the inclined region 215c when the pushing member 220 is located at the first position P1. The inclination angle θ2 of the insertion hole 237 can be defined as the angle between an imaginary line A1' parallel to the central axis c1 and a line along the inner circumferential surface of the insertion hole 237 when the pushing member 220 is located at the first position P1.

[0061] 4 and 5 , when the pushing member 220 is moved from the first position P1 to the second position P2, the hemostatic valve assembly 200 applies a pushing force from the base end to the distal end to the sealing member 230 from the main body 221 of the pushing member 220. When the sealing member 230 is pushed toward the distal end by the main body 221 of the pushing member 220, the distal end 231 of the sealing member 230 is pressed against the inclined region 215c. When the distal end 231 of the sealing member 230 is pressed against the inclined region 215c, the vicinity of the distal end 231 is compressed and deformed so as to close the insertion hole 237.

[0062] In the hemostasis valve assembly 200, the inclination angle θ1 of the inclined region 215c of the housing member 210 is more obtuse than the inclination angle θ2 of the insertion hole 237 of the seal member 230, so that the inner diameter of the insertion hole 237 narrows more steeply toward the distal end than the inner diameter of the inclined region 215c of the housing member 210. Therefore, when the distal end 231 of the seal member 230 is pressed against the inclined region 215c by the main body 221 of the pushing member 220, the hemostasis valve assembly 200 can compressively deform the seal member 230 to efficiently narrow the insertion hole 237 near the distal end 231. This allows the hemostasis valve assembly 200 to quickly form an occlusion portion S with high sealing properties near the distal end 231 of the seal member 230.

[0063] As shown in Figure 7, when the pushing member 220 moves to the second position P2 and the sealing member 230 forms an obstruction section S, the pushing member 220 is moved back to the first position P1, and the hemostatic valve assembly 200 releases the pressing force exerted by the pushing member 220 on the sealing member 230.

[0064] When the pushing member 220 releases the pressing force applied to the seal member 230, the hemostatic valve assembly 200 expands so that the seal member 230 returns to its original shape from its compressed and deformed state. As shown in FIG. 8 , as the seal member 230 expands, it moves toward the proximal end of the inclined region 215c of the housing member 210, which has a larger diameter than the distal end of the inclined region 215c. At this time, the seal member 230 slides toward the proximal end along the inclined region 215c. The seal member 230 then moves to a position where the distal end surface 221a of the main body 221 of the pushing member 220, which is located at the first position P1, abuts against the proximal end surface 233a of the seal member 230. When the seal member 230 moves to this position, the hemostatic valve assembly 200 switches to an open state in which no occlusion portion S is formed in the seal member 230.

[0065] 2, when the pushing member 220 is located at the first position P1, the entire range of the seal member 230 along the longitudinal direction (thickness direction) from the tip end 231 to the base end 233 is disposed in the cylindrical region 215d, and when the pushing member 220 is located at the second position P2, the entire range of the seal member 230 along the longitudinal direction (thickness direction) from the tip end 231 to the base end 233 is disposed in the inclined region 215c (see FIGS. 4 and 5). However, it is sufficient that the seal member 230 is disposed in the housing member 210 so that, when the pushing member 220 is located at the second position P2, a blocking portion S that blocks the insertion hole 237 can be formed in at least a portion of the tip end 231 located near the tip surface 231a. Therefore, there are no particular restrictions on the specific placement of the sealing member 230 relative to the housing member 210, as long as, when the pushing member 220 is positioned at the first position P1, at least a portion thereof including the base end 233 is positioned in the cylindrical region 215d, and when the pushing member 220 is positioned at the second position P2, at least a portion thereof including the tip end 231 is positioned in the inclined region 215c.

[0066] As shown in FIG. 2, the second through-hole 227 of the pushing member 220 decreases in diameter from the base end surface 221 b of the main body 221 of the pushing member 220 toward the tip end surface 221 a.

[0067] The diameter d21 of the tip of the second through-hole 227 of the pushing member 220 is approximately the same as or equal to the diameter d12 of the base end of the insertion hole 237 of the seal member 230. With this structure, when the dilator 300 or a medical device is inserted from the second through-hole 227 of the pushing member 220 into the insertion hole 237 of the seal member 230, the medical instrument 10 can prevent the tip of the dilator tube 310 or the tip of the medical device from coming into contact with the base-end surface 233a of the seal member 230, which would cause damage to the seal member 230. Furthermore, since the contact area between the distal end surface 221a of the pushing member 220 and the proximal end surface 233a of the sealing member 230 can be ensured, when the pushing member 220 is moved from the first position P1 to the second position P2, a pushing force toward the distal side can be efficiently applied from the distal end surface 221a of the main body 221 of the pushing member 220 to the proximal end surface 233a of the sealing member 230. In particular, as shown in FIG. 3 , it is preferable that the diameter d21 of the distal end of the second through hole 227 of the pushing member 220 is approximately the same as the diameter d12 of the proximal end of the insertion hole 237 of the sealing member 230.

[0068] In this embodiment, as shown in Fig. 3 , in the hemostatic valve assembly 200, the diameter d21 of the distal end of the second through-hole 227 of the pushing member 220 and the diameter d12 of the proximal end of the insertion hole 237 of the sealing member 230 are substantially the same. Therefore, in the cross section shown in Fig. 3 , the hemostatic valve assembly 200 can prevent a step (e.g., a step formed by the proximal end 233 of the sealing member 230 protruding in a direction intersecting the axial direction) from being formed at the boundary position where the distal surface 221a of the main body 221 of the pushing member 220 and the proximal surface 233a of the sealing member 230 abut against each other. This prevents the distal end of the dilator tube 310 or the distal end of the medical device from coming into contact with the step and causing damage to the sealing member 230 when the dilator 300 or the medical device is inserted from the first through-hole 217 of the pushing member 220 into the insertion hole 237 of the sealing member 230.

[0069] Furthermore, in the present embodiment, when the pushing member 220 moves to the second position P2, the distal end surface 221a of the main body 221 of the pushing member 220 moves toward the distal end while making surface contact with the proximal end surface 233a of the sealing member 230. At this time, a force perpendicular to the surface direction acts on the proximal end surface 233a of the sealing member 230, and therefore, almost no compressive deformation that would block the insertion hole 237 occurs near the proximal end 233 of the sealing member 230.

[0070] As described above, in the hemostasis valve assembly 200, the diameter d21 of the distal end of the second through hole 227 of the pushing member 220 is substantially the same as the diameter d12 of the proximal end of the insertion hole 237 of the sealing member 230. In addition, in the hemostasis valve assembly 200, the diameter of the second through hole 227 of the pushing member 220 decreases from the proximal end surface 221b of the main body 221 toward the distal end surface 221a. Therefore, in the cross section shown in Fig. 3, the hemostasis valve assembly 200 can prevent a step from being formed at the boundary position where the distal end surface 221a of the main body 221 of the pushing member 220 abuts against the proximal end surface 233a of the sealing member 230 (for example, a step formed by the proximal end 233 of the sealing member 230 protruding in a direction intersecting the axial direction), and can ensure a larger diameter d22 of the proximal end of the second through hole 227. This makes it possible for the medical device 10 to insert a larger diameter dilator 300 or medical device through the hemostatic valve assembly 200 and sheath member 100 from the base end side of the second through hole 227 of the pushing member 220.

[0071] Furthermore, in the hemostasis valve assembly 200, the diameter d21 of the distal end of the second through-hole 227 of the pushing member 220 and the diameter d12 of the proximal end of the insertion hole 237 of the seal member 230 are substantially the same, which increases the area (contact area) where the distal end surface 221a of the main body 221 of the pushing member 220 abuts on the proximal end surface 233a of the seal member 230. This makes it possible to efficiently apply a force from the distal end surface 221a of the main body 221 of the pushing member 220 to the proximal end surface 233a of the seal member 230, pushing the seal member 230 toward the distal side, when the pushing member 220 is moved from the first position P1 to the second position P2.

[0072] As shown in FIG. 3, when the pushing member 220 is located at the first position P1, the diameter d11 of the tip of the insertion hole 237 of the sealing member 230 is smaller than the diameter d21 of the tip of the second through hole 227 of the pushing member 220.

[0073] Furthermore, insertion hole 237 of seal member 230 is disposed so as to be located closer to the central axis c1 of sheath member 100 than the tip of second through hole 227 of pushing member 220. That is, in the cross-sectional view shown in FIG. 3 , insertion hole 237 of seal member 230 is located within region Ps obtained by projecting the tip, which is located on tip surface 221 a of second through hole 227 of pushing member 220, onto insertion hole 237 of seal member 230.

[0074] As described above, in the hemostatic valve assembly 200, the diameter d11 of the tip of the insertion hole 237 of the sealing member 230 when the pushing member 220 is located at the first position P1 is smaller than the diameter d21 of the tip of the second through hole 227 of the pushing member 220, so that the diameter d21 of the tip of the second through hole 227 can be kept as large as possible, and when the pushing member 220 moves from the first position P1 to the second position P2, the insertion hole 237 can be more reliably blocked near the tip 231 of the sealing member 230.

[0075] Furthermore, in the hemostasis valve assembly 200, the insertion hole 237 of the seal member 230 is located closer to the central axis c1 of the sheath member 100 than the tip of the second through-hole 227 of the pushing member 220, making it possible to reduce the amount of compressive deformation of the seal member 230 required to form an occlusion portion S near the tip portion 231 of the seal member 230. Therefore, in the hemostasis valve assembly 200, the occlusion portion S can exhibit high sealing properties even when the outer diameter D1 of the seal member 230 is reduced in order to make the seal member 230 more compact.

[0076] As shown in FIG. 3, the length L of the inclined region 215c along the longitudinal direction of the housing member 210 is greater than the thickness t of the seal member 230 along the longitudinal direction of the housing member 210 when the pushing member 220 is located at the first position P1.

[0077] As described above, in the hemostatic valve assembly 200, the length L of the inclined region 215c along the longitudinal direction of the housing member 210 is greater than the thickness t of the sealing member 230 along the longitudinal direction of the housing member 210 when the pushing member 220 is positioned at the first position P1, so that when the pushing member 220 moves to the second position P2, the sealing member 230 can be prevented from being pushed beyond the inclined region 215c of the housing member 210 and into the tip region 215a located further distal than the inclined region 215c. As a result, as shown in Figures 7 and 8, when the pushing member 220 is moved to the second position P2 to switch to the blocked state, and then the pushing member 220 is moved back to the first position P1, the sealing member 230 can be quickly moved to a position where the base end surface 233a of the sealing member 230 abuts the tip end surface 221a of the main body portion 221 of the pushing member 220, along with the movement of the pushing member 220 toward the base end.

[0078] An example of dimensions of each part of the hemostasis valve assembly 200 will now be described with reference to FIG.

[0079] The inclination angle θ1 of the inclined region 215c of the housing member 210 can be formed to be more obtuse than the inclination angle θ2 of the insertion hole 237 of the seal member 230. The inclination angle θ1 can be formed to be, for example, not less than 28° and not more than 45°.

[0080] When the inclination angle θ1 of the inclined region 215c of the housing member 210 is formed to the above-mentioned magnitude, the inclination angle θ2 of the insertion hole 237 of the seal member 230 can be formed to be, for example, 5° or more and 39° or less.

[0081] The outer diameter D1 of the seal member 230 can be formed to be, for example, 12 mm or more and 20 mm or less.

[0082] The outer diameter D2 of the main body 221 of the pushing member 220 can be formed to be, for example, substantially the same size as the outer diameter D1 of the sealing member 230. The outer diameter D2 can be formed to be, for example, 12 mm or more and 20 mm or less.

[0083] The diameter d11 of the tip of the insertion hole 237 of the sealing member 230 when the pushing member 220 is located at the first position P1 can be formed to be smaller than the diameter d21 of the tip of the second through hole 227 of the pushing member 220. The diameter d11 can be formed to be, for example, 4 mm or more and 10 mm or less.

[0084] The diameter d12 of the base end of the insertion hole 237 of the sealing member 230 when the pushing member 220 is located at the first position P1 is larger than the diameter d11 of the tip end of the insertion hole 237 of the sealing member 230 when the pushing member 220 is located at the first position P1. The diameter d12 can be, for example, 10 mm or more and 16 mm or less.

[0085] When the diameter d11 of the tip of the insertion hole 237 of the sealing member 230 when the pushing member 220 is located at the first position P1 is formed to the above size, the diameter d21 of the tip of the second through hole 227 of the pushing member 220 can be formed to be, for example, 9 mm or more and 16 mm or less. Note that it is preferable that the diameter d12 of the base end of the insertion hole 237 of the sealing member 230 and the diameter d21 of the tip of the second through hole 227 of the pushing member 220 be formed to be approximately the same size.

[0086] The diameter d22 of the base end of the second through-hole 227 of the pushing member 220 can be formed to be, for example, 10 mm or more and 18 mm or less.

[0087] The length L of the inclined region 215c along the longitudinal direction of the housing member 210 can be formed to be greater than the thickness t of the seal member 230 along the longitudinal direction of the housing member 210 when the pushing member 220 is located at the first position P1. The length L can be formed to be, for example, 3 mm or more and 6 mm or less.

[0088] The thickness t of the sealing member 230 along the longitudinal direction of the housing member 210 when positioned at the first position P1 can be formed to be, for example, 3 mm or more and 5 mm or less when the length L of the inclined region 215c along the longitudinal direction of the housing member 210 is formed to the above-mentioned size.

[0089] The material constituting the sealing member 230 is not particularly limited as long as it is an elastic material that can compress and deform the tip portion 231 of the sealing member 230 to form the closed portion S when the pushing member 220 is moved from the first position P1 to the second position P2, and that can return the sealing member 230 to the open state when the pushing member 220 is moved back to the first position P1 after the pushing member 220 has been moved to the second position P2 to switch to the closed state. For example, the material constituting the sealing member 230 is an elastic material, and examples thereof include synthetic rubbers such as silicone rubber, fluororubber, and urethane rubber, natural rubber, and elastomers such as amide elastomers, styrene elastomers, and olefin elastomers.

[0090] As described above, the diameter d12 of the base end of the insertion hole 237 of the seal member 230 is larger than the diameter d11 of the tip end of the insertion hole 237 of the seal member 230. In addition, it is preferable that the diameter d12 of the base end of the insertion hole 237 of the seal member 230 has a length that is ⅓ or more of the outer diameter D1 of the seal member. Furthermore, it is preferable that the diameter d12 of the base end of the insertion hole 237 of the seal member 230 is larger than the thickness t of the seal member 230. With this configuration, the proportion of the area of ​​the insertion hole 237 that occupies the proximal surface 233a of the seal member 230 is increased, and when the distal end 231 of the seal member 230 is compressively deformed to form the occlusion S as the pushing member 220 is moved from the first position P1 to the second position P2, a guide surface (a cross section whose width narrows toward the distal end) that guides the dilator 300 or a medical device to the occlusion S of the insertion hole 237 can be effectively formed in the insertion hole 237 located on the proximal end 233 side of the seal member, as shown in Fig. 5. Furthermore, because the diameter d12 of the proximal end of the insertion hole 237 of the seal member 230 is larger than the thickness t of the seal member 230, the volume of the seal member 230 can be reduced, and the force applied by the surgeon or the like to move the pushing member 220 from the first position P1 to the second position P2 can be reduced.

[0091] As shown in FIGS. 9 to 11, the housing member 210 has guide grooves 218 and 219 that guide the movement of the pushing member 220 between the first position P1 and the second position P2.

[0092] The guide grooves 218, 219 are arranged as a pair at opposing positions on the housing member 210 with the central axis c1 therebetween.

[0093] Guide groove 218 (hereinafter referred to as "first guide groove 218") extends between one end 218a and the other end 218b provided at a position closer to the tip of housing member 210 than one end 218a. Similarly, guide groove 219 (hereinafter referred to as "second guide groove 219") extends between one end 219a and the other end 219b provided at a position closer to the tip of housing member 210 than one end 219a.

[0094] Between one end 218a and the other end 218b of the first guide groove 218, there is provided an inclined portion 218c extending obliquely toward the tip side of the housing member 210, and a straight portion 219d extending circumferentially around the central axis c1 along the outer peripheral surface of the housing member 210. Between one end 219a and the other end 219b of the second guide groove 219, there is provided an inclined portion 219c extending obliquely toward the tip side of the housing member 210, and a straight portion 219d extending circumferentially around the central axis c1 along the outer peripheral surface of the housing member 210.

[0095] 9, the base end of the housing member 210 has a cylindrical outer shape. Therefore, when the arms 224a, 224b move along the guide grooves 218, 219, the arms 224a, 224b move in a direction inclined relative to the central axis c1 and rotate in the circumferential direction around the central axis c1.

[0096] 9 , the guide grooves 218, 219 are preferably provided at positions on the outer circumferential surface of the housing member 210 that do not overlap with the port portions 251, 252 provided in the housing member 210 in the circumferential direction. By providing the guide grooves 218, 219 in this manner, it is possible to prevent the fingers of the surgeon or the like from interfering with the port portions 251, 252 when moving the pushing member 220 between the first position P1 and the second position P2. This enables the medical device 10 to smoothly switch the hemostatic valve assembly 200 between the open state and the closed state.

[0097] As shown in Figure 10, the pushing member 220 is positioned at the first position P1 with the first arm portion 224a positioned at one end 218a of the first guide groove 218 and the second arm portion 224b positioned at one end 219a of the second guide groove 219.

[0098] By hooking a finger on the finger loop portion 228 and rotating it, the surgeon can move the first arm portion 224a from one end 218a of the first guide groove 218 toward the other end 218b, while moving the second arm portion 224b from one end 219a of the second guide groove 219 toward the other end 219b.

[0099] 11 , when the arm portions 224a, 224b of the pushing member 220 move along the guide grooves 218, 219, the main body portion 221 connected to the arm portions 224a, 224b moves toward the tip side of the housing member 210. When the pushing member 220 moves to the second position P2, it pushes the tip portion 231 of the seal member 230 into the inclined region 215c of the housing member 210, forming a blocking portion S near the tip portion 231 of the seal member 230 (see FIG. 5 ). At this time, the seal member 230 is subjected to a pressing force generated by the movement of the main body portion 221 of the pushing member 220 toward the tip side, as well as a rotational force generated by the rotation of the pushing member 220. Therefore, when the pushing member 220 moves from the first position P1 to the second position P2, the pushing member 220 can efficiently apply a force to the sealing member 230 to form a blocking portion S near the tip portion 231 of the sealing member 230.

[0100] When the pushing member 220 moves to the second position P2, the arm portions 224a, 224b are held by the straight portions 218d, 219d connected to the other ends 218b, 219b of the guide grooves 218, 219. Therefore, the hemostatic valve assembly 200 can prevent the arm portions 224a, 224b from inadvertently moving toward the ends 218a, 219a of the guide grooves 218, 219 after the pushing member 220 is moved to the second position P2. This allows the hemostatic valve assembly 200 to maintain the position of the pushing member 220 in the longitudinal direction of the housing member 210. Therefore, the hemostatic valve assembly 200 can preferably maintain the state in which the occlusion portion S is formed at the distal end 231 of the seal member 230.

[0101] 2 , when the pushing member 220 is located at the first position P1, the pushing member 220 is located further distal than the cap member 240. Therefore, the surgeon can smoothly move the pushing member 220 between the first position P1 and the second position P2 without the pushing member 220 interfering with the cap member 240, which has an opening 241 that forms an insertion portion for inserting the dilator 300 or a medical device into the hemostatic valve assembly 200.

[0102] The outer circumferential portion 223 of the pushing member 220, which is disposed outside the housing member 210, can be configured to have a polygonal (e.g., hexagonal) shape in a plan view seen from the base end side of the cap member 240. When the outer circumferential portion 223 is formed in such a shape, it becomes easier for the surgeon to place his or her fingers on the outer circumferential portion 223, making it possible to easily move the pushing member 220 between the first position P1 and the second position P2 with one hand. Note that when the outer circumferential portion 223 of the pushing member 220 is formed in a polygonal shape as described above, the provision of the finger hook 228 may be omitted as appropriate.

[0103] As shown in FIG. 1 , the housing member 210 has a first port portion 251 and a second port portion 252 .

[0104] Each port portion 251 , 252 is arranged so as to communicate with the first through-hole 217 of the housing member 210 in the tip region 215 a that is located on the tip side of the inclined region 215 c of the housing member 210 .

[0105] As shown in FIG. 1, the first port portion 251 can be connected to a tube 255 a connected to a three-way stopcock 257 for supplying a liquid such as physiological saline into the housing member 210 .

[0106] 1, a suction device can be connected to the second port 252 via a predetermined tube 255b. 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 252 can be omitted as appropriate depending on the intended use of the medical device 10, etc.

[0107] <Dilator 300> As shown in FIG. 1, the dilator 300 includes a dilator tube 310 and a dilator hub 320.

[0108] The dilator 300 can detachably fix the dilator hub 320 to the cap member 240 with the dilator tube 310 inserted through the hemostatic valve assembly 200 and the inner cavity 105 of the sheath member 100.

[0109] 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 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 body lumen through the perforation as described above.

[0110] 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.

[0111] 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 230 in a state in which a blocking portion S is formed by blocking the insertion hole 237 near the distal end 231 of the seal member 230 (blocked state), as shown in Fig. 6. The seal member 230 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 240. The surgeon may insert the dilator tube 310 into the insertion hole 237 of the seal member 230, and then operate the pushing member 220 to bring the seal member 230 into close contact with the outer peripheral surface of the dilator tube 310, thereby blocking the insertion hole 237 of the seal member 230 and preventing liquids such as blood or saline injected into the housing member 210 from flowing back toward the base end of the cap member 240, and then use the medical device 10.

[0112] As described above, the medical device 10 according to this embodiment has a tubular sheath member 100 and a hemostatic valve assembly 200 connected to the proximal end 103 of the sheath member 100. The hemostatic valve assembly 200 comprises a housing member 210 having a first through hole 217 extending from the distal end 211 to the proximal end 213, a pushing member 220 configured to be movable along the housing member 210 and having a second through hole 227 extending from the distal end to the proximal end, and a sealing member 230 located distally of the pushing member 220 and having an insertion hole 237 communicating with the first through hole 217 and the second through hole 227. The housing member 210 is a cylindrical member located distally of the pushing member 220. The pushing member 220 is configured to be movable between a first position P1 where the base end 233 of the sealing member 230 is located in the cylindrical region 215d and a second position P2 where the base end 233 of the sealing member 230 is located closer to the tip of the cylindrical region 215d than the first position P1 and where at least a portion of the tip end 231 of the sealing member 230 is pushed into the inclined region 215c, and the insertion hole 237 of the sealing member 230 decreases in diameter from the base end surface 233a toward the tip end surface 231a, and the inclination angle θ1 of the inclined region 215c is more obtuse than the inclination angle θ2 of the insertion hole 237.

[0113] As described above, the hemostatic valve assembly 200 included in the medical device 10 includes the housing member 210 having the first through hole 217, the pushing member 220 having the second through hole 227 communicating with the first through hole 217, and the seal member 230 having the insertion hole 237 communicating with the first through hole 217 and the second through hole 227. The hemostatic valve assembly 200 is configured to be selectively switchable between an open state in which the first through hole 217, the second through hole 227, and the insertion hole 237 are all connected, and a closed state in which the second through hole 227 of the seal member 230 is closed by compressive deformation of the seal member 230.

[0114] Furthermore, when the pushing member 220 is moved from the first position P1 to the second position P2, the pushing member 220 applies a pushing force from the base end to the distal end to the sealing member 230. When the sealing member 230 is pushed toward the distal end as the pushing member 220 moves, the sealing member 230 presses the distal end portion 231 of the sealing member 230 against the inclined region 215c. As a result, the sealing member 230 compresses and deforms the distal end portion 231 located near the distal end surface 231a of the insertion hole 237. In the hemostasis valve assembly 200, the inclination angle θ1 of the inclined region 215c of the housing member 210 is more obtuse than the inclination angle θ2 of the insertion hole 237 of the seal member 230, and therefore the inner diameter of the insertion hole 237 tapers more steeply toward the distal end than the inner diameter of the inclined region 215c of the housing member 210. Therefore, when the distal end portion 231 of the seal member 230 is pressed against the inclined region 215c, the hemostasis valve assembly 200 can be deformed to efficiently narrow the vicinity of the distal end surface 231a of the insertion hole 237. By deforming the seal member 230 to narrow the vicinity of the distal end surface 231a of the insertion hole 237, the hemostasis valve assembly 200 can form an occlusion portion S at the distal end portion 231 of the hemostasis valve assembly 200. The occlusion portion S formed at the distal end portion 231 of the seal member 230 allows the hemostasis valve assembly 200 to exhibit high sealing properties.

[0115] Furthermore, the hemostatic valve assembly 200 is configured to form a blocking portion S that blocks the insertion hole 237 by compressing and deforming the tip portion 231 of the seal member 230 with the pushing member 220, so that when the dilator 300 or a medical device is inserted into the seal member 230 in a state in which the blocking portion S is formed, the seal member 230 can be deformed so that the blocking portion S is expanded to match the outer diameter of the dilator 300 or various medical devices while maintaining close contact between the dilator 300 or medical device and the blocking portion S. Therefore, when the surgeon or the like operates the pushing member 220 to switch to the blocked state, the surgeon or the like can smoothly insert the dilator 300 or a medical device into the seal member 230 without impairing the sealing properties of the blocking portion S formed in the seal member 230.

[0116] 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.

[0117] Further, the pushing member 220 has a distal end surface 221a that abuts against a proximal end surface 233a of the sealing member 230, and the proximal end surface 233a of the sealing member 230 and the distal end surface 221a of the pushing member 220 have cross-sectional shapes that are approximately parallel.

[0118] As described above, in the hemostasis valve assembly 200, the distal end surface 221a of the pushing member 220 and the proximal end surface 233a of the sealing member 230 have cross-sectional shapes that are substantially parallel, so that when the pushing member 220 moves from the first position P1 to the second position P2, a force can be efficiently applied from the distal end surface 221a of the main body 221 of the pushing member 220 to the proximal end surface 233a of the sealing member 230, pushing the sealing member 230 toward the distal side. This allows the hemostasis valve assembly 200 to smoothly switch from the open state to the closed state.

[0119] In addition, the second through hole 227 narrows in diameter from the base end surface 221b of the pushing member 220 toward the tip end surface 221a, and the diameter d21 of the tip of the second through hole 227 is approximately the same as the diameter d12 of the base end of the insertion hole 237, or is smaller than the diameter d12 of the base end of the insertion hole 237.

[0120] By configuring the second through hole 227 as described above, the medical instrument 10 can prevent the distal end of the dilator tube 310 or the distal end of the medical device from coming into contact with the proximal surface 233a of the seal member 230 when the dilator 300 or the medical device is inserted from the second through hole 227 of the pushing member 220 into the insertion hole 237 of the seal member 230, thereby preventing damage to the seal member 230. Furthermore, because the contact area between the distal end surface 221a of the pushing member 220 and the proximal surface 233a of the seal member 230 can be ensured, when the pushing member 220 is moved from the first position P1 to the second position P2, a pushing force toward the distal side can be efficiently applied from the distal end surface 221a of the main body 221 of the pushing member 220 to the proximal surface 233a of the seal member 230. Furthermore, the medical device 10 can be configured so that the diameter d21 of the distal end of the second through-hole 227 of the pushing member 220 and the diameter d12 of the proximal end of the insertion hole 237 of the sealing member 230 are substantially the same, and in addition, the second through-hole 227 of the pushing member 220 tapers in diameter from the proximal end surface 221b toward the distal end surface 221a of the main body 221. With this configuration, the hemostasis valve assembly 200 can prevent a step from being formed at the boundary position where the distal end surface 221a of the main body 221 of the pushing member 220 abuts against the proximal end surface 233a of the sealing member 230 (for example, a step formed by the proximal end 233 of the sealing member 230 protruding in a direction intersecting the axial direction), and can ensure a larger diameter d22 of the proximal end of the second through-hole 227. This makes it possible for the medical device 10 to insert a larger diameter dilator 300 or medical device through the hemostatic valve assembly 200 and sheath member 100 from the base end side of the second through hole 227 of the pushing member 220.

[0121] Furthermore, when the pushing member 220 is positioned at the first position P1, the diameter d11 of the tip of the insertion hole 237 is smaller than the diameter d21 of the tip of the second through hole 227, and the insertion hole 237 is positioned closer to the central axis c1 of the sheath member 100 than the tip of the second through hole 227.

[0122] In the hemostasis valve assembly 200, the diameter d11 of the tip of the insertion hole 237 of the seal member 230 when the pushing member 220 is located at the first position P1 is smaller than the diameter d21 of the tip of the second through hole 227 of the pushing member 220 as described above, so that the diameter d21 of the tip of the second through hole 227 can be ensured to be as large as possible, and when the pushing member 220 moves from the first position P1 to the second position P2, the insertion hole 237 can be more reliably closed near the tip portion 231 of the seal member 230. Furthermore, in the hemostasis valve assembly 200, the insertion hole 237 of the seal member 230 is located closer to the central axis c1 of the sheath member 100 than the tip of the second through hole 227 of the pushing member 220, so that the amount of compressive deformation of the seal member 230 required to form the occlusion portion S near the tip portion 231 of the seal member 230 can be kept small. Therefore, the hemostatic valve assembly 200 can ensure that the occlusion portion S exhibits high sealing properties even when the outer diameter D1 of the seal member 230 is reduced in order to make the seal member 230 smaller.

[0123] Furthermore, the length L of the inclined region 215c along the longitudinal direction of the housing member 210 is greater than the thickness t of the seal member 230 along the longitudinal direction of the housing member 210 when the pushing member 220 is located at the first position P1.

[0124] As described above, in the hemostasis valve assembly 200, the length L of the inclined region 215c along the longitudinal direction of the housing member 210 is greater than the thickness t of the seal member 230 along the longitudinal direction of the housing member 210 when the pushing member 220 is located at the first position P1. Therefore, when the pushing member 220 moves to the second position P2, the seal member 230 can be prevented from going beyond the inclined region 215c of the housing member 210 and being pushed into the distal region 215a of the housing member 210. As a result, when the pushing member 220 is moved to the second position P2 to switch to the closed state and then moved back to the first position P1, the hemostasis valve assembly 200 can quickly move the seal member 230 to a position where the proximal surface 233a of the seal member 230 abuts against the distal surface 221a of the main body 221 of the pushing member 220, accompanying the movement of the pushing member 220 toward the proximal end.

[0125] In addition, the housing member 210 has guide grooves 218, 219 that guide the movement of the pushing member 220 between the first position P1 and the second position P2, and the pushing member 220 has arm portions 224a, 224b that are held in the guide grooves 218, 219 and are movable along the guide grooves 218, 219.

[0126] As described above, in the hemostasis valve assembly 200, the housing member 210 has the guide grooves 218, 219 that guide the movement of the pushing member 220 between the first position P1 and the second position P2, and the pushing member 220 is held in the guide grooves 218, 219 and has the arm portions 224a, 224b that are movable along the guide grooves 218, 219. Therefore, the surgeon or the like can easily move the pushing member 220 from the first position P1 to the second position P2 by sliding the arm portions 224a, 224b along the guide grooves 218, 219. This allows the surgeon or the like to easily and smoothly switch the hemostasis valve assembly 200 between the open state and the closed state.

[0127] The medical device 10 also has a cap member 240 connected to the base end 213 of the housing member 210 and having an opening 241 formed therein, and the pushing member 220 is positioned further distal than the cap member 240 when the pushing member 220 is positioned at the first position P1.

[0128] The medical device 10 further has a cap member 240 that is connected to the base end 213 of the housing member 210 as described above and has an opening 241 formed therein.When the pushing member 220 is located at the first position P1, it is positioned further distal than the cap member 240.Therefore, the surgeon can smoothly move the pushing member 220 between the first position P1 and the second position P2 without the pushing member 220 interfering with the cap member 240, which has an opening 214 that serves as an insertion position for inserting a dilator 300 or a medical device into the hemostatic valve assembly 200.

[0129] (Modification of Hemostatic Valve Assembly) FIGS. 12 and 13 show a modification of the hemostatic valve assembly 200A.

[0130] In the modified hemostasis valve assembly 200A, the pushing member 220 is integrally formed with the cap member 240.

[0131] An opening 241 is formed at the proximal end of the pushing member 220, which serves as a position for inserting the dilator 300 or a medical device into the hemostatic valve assembly 200.

[0132] Similar to the above-described embodiment, the pushing member 220 is connected to the housing member 210 in a state in which it can move from the first position P1 to the second position P2.

[0133] A finger hook 228 for hooking the fingers of an operator or the like can be attached to the pushing member 220. Configuring the pushing member 220 with the finger hook 228 makes it easier to operate the movement of the pushing member 220. The operator or the like can easily switch between the open state and the closed state with one hand by hooking their fingers or the like on the finger hook 228 and moving the cap member 240 along the guide grooves 218, 219 (see FIGS. 9 to 11).

[0134] By constructing the pushing member 220 integrally with the cap member 240 as in the modified hemostasis valve assembly 200A, the number of parts of the hemostasis valve assembly 200A can be reduced, thereby reducing manufacturing costs.

[0135] (Modifications of Seal Member) As shown in FIG. 14, a seal member 230A according to Modification 1 has a tapered portion 238 formed between a distal end portion 231 and a proximal end portion 233.

[0136] The tapered portion 238 is formed so that the outer diameter of the seal member 230A decreases toward the distal end 231. Because the tapered portion 238 is formed between the distal end 231 and the proximal end 233 of the seal member 230A, the outer diameter of the distal end 231 is smaller than the outer diameter of the proximal end 233. Therefore, when the distal end 231 of the seal member 230A is pressed against the inclined region of the housing member as the pushing member moves from the first position to the second position, the distal end 231 of the seal member 230A is more likely to compress and deform. This allows the hemostasis valve assembly to reduce the amount of pushing of the pushing member required to form a blocking portion S near the distal end 231 of the seal member 230A. Therefore, a hemostasis valve assembly including the seal member 230A can more smoothly form a blocking portion S at the distal end 231 of the seal member 230A when the surgeon or the like moves the pushing member along the guide groove. In addition, in order to efficiently form an obstruction portion S near the tip portion 231 of the sealing member 230A, it is preferable that the hemostatic valve assembly be formed so that the inclination angle θ1 of the inclined region 215c of the housing member 210 is more obtuse than the inclination angle of the tapered portion 238 of the sealing member 230A.

[0137] 15 has a slit 239 extending from a tapered portion 238 to a tip end surface 231a. By having the slit 239 as well as the tapered portion 238, the sealing member 230B makes the tip end portion 231 even more susceptible to compressive deformation.

[0138] Furthermore, when the sealing members 230A, 230B shown in the modified examples are used in a hemostatic valve assembly, when the pushing member is positioned in the first position P1, a portion of the base end 233 of each sealing member 230A, 230B can be positioned in the cylindrical region 215d of the housing member 210, and a portion of the tapered portion 238 and tip end 231 of each sealing member 230A, 230B can be positioned in the inclined region 215c of the housing member 210 (see Figure 2).

[0139] The medical device according to the present invention has been described above through embodiments and modifications, but the present invention is not limited to the contents described in this specification and can be modified as appropriate based on the claims.

[0140] 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.

[0141] This application is based on Japanese Patent Application No. 2024-86073, filed on May 28, 2024, the disclosure of which is incorporated herein by reference in its entirety.

[0142] 1 Introducer kit 10 Medical device 100 Sheath member 101 Distal end portion of sheath member 103 Proximal end portion of sheath member 105 Lumen of sheath member 200 Hemostatic valve assembly 200A Hemostatic valve assembly 210 Housing member 211 Distal end portion of housing member 213 Proximal end portion of housing member 215c Inclined region 215d Cylindrical region 217 First through hole 218 First guide groove (guide groove) 219 Second guide groove (guide groove) 220 Pushing member 221 Main body portion of pushing member 221a Distal end surface of main body portion 221b Proximal end surface of main body portion 223 Outer periphery 224a First arm portion (arm portion) 224b Second arm portion (arm portion) 227 Second through hole 228 Finger hook portion 230 Sealing member 230A Seal member 230B Seal member 231 Distal end portion of seal member 231a Distal end surface of seal member 233 Proximal end portion of seal member 233a Proximal end surface of seal member 237 Insertion hole 238 Tapered portion 239 Slit 240 Cap member 241 Opening 251 First port portion 252 Second port portion 300 Dilator 310 Dilator tube 320 Dilator hub P1 First position P2 Second position c1 Central axis of sheath member d11 Diameter of distal end of insertion hole d12 Diameter of proximal end of insertion hole d21 Diameter of distal end of second through hole d22 Diameter of proximal end of second through hole L Length of inclined region t Thickness of seal member θ1 Inclination angle of inclined region θ2 Inclination angle of insertion hole

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 first through hole extending from the distal end to the proximal end; a pushing member configured to be movable along the housing member and having a second through hole extending from the distal end to the proximal end; and a sealing member located distally of the pushing member and having an insertion hole communicating with the first through hole and the second through hole, wherein the housing member has a cylindrical region located distally of the pushing member and a sloped region extending continuously from the distal end of the cylindrical region toward the distal end, the diameter of the first through hole decreasing from the proximal end to the distal end, wherein the pushing member is configured to be movable between a first position where the proximal end of the sealing member is located in the cylindrical region and a second position where the pushing member is located distally of the cylindrical region relative to the first position and at least a part of the distal end of the sealing member is pushed into the sloped region, wherein the insertion hole of the sealing member decreases in diameter from the proximal surface to the distal surface, The medical device, wherein the inclination angle of the inclined region is more obtuse than the inclination angle of the insertion hole.

2. The medical device according to claim 1, wherein the pushing member has a distal end surface that abuts against the proximal end surface, and the proximal end surface and the distal end surface have substantially parallel cross-sectional shapes.

3. The medical device according to claim 1, wherein the second through-hole has a diameter that decreases from the base end surface of the pushing member toward the tip end surface, and the diameter of the tip end of the second through-hole is approximately the same as or smaller than the diameter of the base end of the insertion hole.

4. The medical device according to claim 1, wherein the diameter of the tip of the insertion hole when the pushing member is located at the first position is smaller than the diameter of the tip of the second through hole, and the insertion hole is located closer to the central axis of the sheath member than the tip of the second through hole.

5. The medical device according to claim 1, wherein the length of the inclined region along the longitudinal direction of the housing member is greater than the thickness of the seal member along the longitudinal direction of the housing member when the pushing member is located in the first position.

6. The medical device according to claim 1, wherein the housing member has a guide groove that guides the movement of the pushing member between the first position and the second position, and the pushing member has an arm portion that is held in the guide groove and is movable along the guide groove.

7. The medical device according to claim 1, further comprising a cap member connected to the base end of the housing member and having an opening formed therein, wherein the pushing member is positioned distally of the cap member when the pushing member is in the first position.

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