JP6069819B2 - Medical insertion aid - Google Patents

Description

  The present invention relates to a medical valve body and a medical insertion assisting tool, and more particularly, a medical valve body that has excellent hemostasis and excellent operability with low resistance during insertion and withdrawal of an insert. And a medical insertion aid.

  Intra-aortic balloon pumping method (so-called IABP method) used for the treatment of heart failure such as heart failure, and percutaneous coronary artery formation method (so-called PTCA method) used for the treatment of expanding blood vessels around the heart In a treatment method or diagnostic method such as a thermodilution catheter method (so-called TDC method) used for measuring the blood flow of the heart, a catheter tube is inserted into a patient's arteriovenous blood vessel. In order to insert such a catheter tube into a patient's blood vessel, a medical insertion aid (for example, an introducer) is used.

  The introducer has a sheath having a through hole formed therein. A needle-shaped dilator is inserted into the sheath as necessary, and in this state, the tip of the dilator is inserted into the blood vessel of the patient, and the blood vessel insertion port is pushed out by the dilator. Thereafter, the dilator is extracted from the proximal end portion of the sheath. The distal end of the sheath remains inserted into the blood vessel insertion port. Thereafter, the catheter tube is introduced into the blood vessel through the internal hole of the sheath.

  In such an introducer, a medical valve body is attached to the proximal end portion of the sheath, and blood is passed from the patient's blood vessel through the sheath until the catheter tube is inserted after the dilator is extracted from the sheath. Prevents leakage. This medical valve body is required to exhibit a hemostatic action while the dilator is inserted into the sheath and while the catheter tube is inserted into the blood vessel through the sheath.

  As a medical valve element to be mounted in a sheath, an elastic disk-shaped valve element in which a close contact hole made of a cross-shaped or Y-shaped slit is formed is known.

  However, in the conventional valve body, resistance when a catheter or a guide wire is inserted into the valve body becomes high, and insertion of the catheter or the like may not be easy in a medical field.

  Therefore, as shown in Patent Document 1 below, a plurality of raised objects are formed in the radial direction and the circumferential direction around the close-contact hole into which the dilator is inserted at the inlet surface of the valve body on the side where the dilator or the like is inserted. There has been proposed a medical valve element that is intermittently molded integrally. According to this medical valve body, the hemostatic property of the valve body is maintained well, and the resistance at the time of insertion and passage of a dilator or the like is smaller than the conventional one.

  However, the medical valve body disclosed in Patent Document 1 has a problem that when the tip of the dilator is to be inserted from the inlet surface of the medical valve body, the tip of the dilator is easily caught by a raised object.

  In recent years, it is desirable to make the tip of the dilator thinner in order to reduce the puncture resistance to the patient by the tip of the dilator. However, if the tip of the dilator is made thin, the tip of the dilator may be crushed when the tip of the dilator is caught by a raised object formed on the inlet surface of the medical valve body. Therefore, there is a problem that the tip of the dilator cannot be formed thin.

JP-A-11-276595

  The present invention has been made in view of such a situation, and its purpose is that hemostasis is good, resistance during insertion and withdrawal of the insert is small, operability is excellent, and the tip of the insert is crushed, etc. It is to provide a medical valve body and a medical insertion aid that can effectively suppress the above.

In order to achieve the above object, the medical valve body according to the present invention is:
It is composed of an elastic valve body in which a close-contact hole that can be inserted and withdrawn while maintaining liquid tightness so as to penetrate from the inlet surface to the outlet surface of the valve body,
A plurality of guide grooves are formed radially in the circumferential direction around the contact hole on the inlet surface of the valve body on the side where the elongated insert is inserted.

  In the medical valve body according to the present invention, when the distal end of a long insert such as a dilator is inserted into the close contact hole of the valve body, the distal end of the insert is along a guide groove formed on the inlet surface of the valve body. Guided to the sliding contact hole. Therefore, even if the tip of the dilator or the like is narrowed, it is guided to the sliding contact hole along the guide groove without being crushed. For this reason, the tip of the dilator or the like can be made thin, and the puncture resistance to the patient by the tip of the dilator or the like can be reduced.

  Further, after a long insert such as a dilator is guided to the close-contact hole, when the insert is further inserted into the close-contact hole, a part of the inlet surface located around the close-contact hole is in close contact with the outer periphery of the insert. However, since the guide grooves are formed radially on the entrance surface located around the contact hole, the resistance when inserting and withdrawing the insert is small, and the operability is excellent. Moreover, since the close-contact hole is closed after the insert is removed, the hemostasis is excellent.

  A concave tapered surface inclined toward the contact hole may be formed on the inlet surface of the valve main body, and linear guide grooves may be radially formed on the concave tapered surface. By forming a concave tapered surface inclined toward the contact hole on the inlet surface of the valve body, the tip of the insert can easily slide along the guide groove formed on the inlet surface of the valve body. Guidance becomes easier.

  A groove depth of the guide groove may be deep at the outer peripheral portion and shallow at the inner peripheral portion. When the distal end of an insert such as a dilator first comes into contact with the outer peripheral portion of the inlet surface of the valve body, the distal end portion is easily guided from the outer peripheral portion toward the inner peripheral portion.

  In addition, a small outer diameter long insert such as a guide wire or a large outer diameter long insert such as a catheter tube may be inserted into the close contact hole of the valve body. In this case, hemostasis is required, and low resistance at the time of insertion and withdrawal is required. By forming the groove depth of the guide groove deep at the outer peripheral portion and shallow at the inner peripheral portion, it does not depend on the outer diameter of the long insert, and does not deteriorate hemostasis, and can be inserted and withdrawn. The effect of reducing the resistance is increased.

  A convex taper surface corresponding to the concave taper surface may be formed on the outlet surface corresponding to the entrance surface on which the concave taper surface is formed. By forming a convex taper surface corresponding to the concave taper surface, the thickness of the valve body on which these are formed becomes substantially uniform between the outer peripheral part and the inner peripheral part, and the valve main body contacts the outer periphery of the insert No contact unevenness and uniform adhesion.

  In addition, by providing a recess on the outlet side at the portion corresponding to the close contact hole located at the top of the convex taper surface, the movement of the valve body that comes into contact with the outer periphery of the insert becomes more flexible. The contact resistance of the valve body with respect to the insert during holding decreases.

  A flat surface is formed on the inlet surface of the valve body located on the outer peripheral portion of the concave tapered surface, and the flat surface is formed on the outlet surface of the valve main body located on the outer peripheral portion of the convex tapered surface. May be formed with legs projecting in the opposite direction. The legs may be provided continuously along the circumferential direction of the valve body, or may be provided intermittently.

  By forming the leg portion, it is possible to disperse the compressive force or tensile force generated on the outlet face side of the valve body when the insert is inserted into or pulled out of the close contact hole of the valve body. As a result, the resistance when inserting and withdrawing the insert can be further reduced.

  The groove width of each guide groove may be wider in the outer peripheral portion than in the inner peripheral portion, and the guide groove may be close to the circumferential direction in the inner peripheral portion located around the contact hole. . When the distal end of an insert such as a dilator first comes into contact with the outer peripheral portion of the inlet surface of the valve body, the distal end portion is easily guided from the outer peripheral portion toward the inner peripheral portion. Further, with this configuration, the effect of reducing resistance during insertion and withdrawal of the insert is increased without reducing hemostasis regardless of the outer diameter of the long insert.

  The contact hole of the valve body may have an insertion hole having a bottom portion and a slit-like slit continuous to the bottom portion of the insertion hole. The cut slit may be configured to have a wider slit width toward the exit surface. You may provide the said exit side recessed part corresponding to a slit width | variety in an exit surface. The insertion hole having the bottom is preferably formed on the entrance surface side, but it is not always necessary to form the insertion hole. That is, the close-contact hole may be configured only with a slit. Although it does not specifically limit as a notch-shaped slit, A cross-shaped or Y-shaped slit is illustrated.

  The medical insertion assistance tool which concerns on this invention has the medical valve body as described above, and the sheath holding the said medical valve body.

FIG. 1A is a plan view of a medical valve element according to an embodiment of the present invention, and FIG. 1B is an enlarged plan view of a guide groove shown in FIG. 2A is a perspective view of the medical valve element shown in FIG. 1, FIG. 2B is a sectional view taken along line IIB-IIB shown in FIG. 1A, and FIG. 2C is a medical valve element. FIG. 3A is a cross-sectional view taken along line IIIB-IIIB shown in FIG. 1A, and FIG. 3B is an enlarged cross-sectional view of the guide groove near the contact hole shown in FIG. 3A. FIG. 4 is a schematic cross-sectional view showing the middle of inserting the dilator into the introducer. FIG. 5 is a schematic side view showing the middle of inserting the dilator into the introducer. 6 is a cross-sectional view of the main part of the cap portion shown in FIG. FIG. 7 is a schematic side view showing a use state of the medical insertion aid.

Hereinafter, the present invention will be described based on embodiments shown in the drawings.
The medical valve body 40 according to the present embodiment shown in FIGS. 1 to 3 is attached to the proximal end portion of the introducer 6 as a medical insertion aid shown in FIGS. 4 to 7, for example. The introducer 6 is used in combination with the dilator 4 as shown in FIGS.

First, the outline of the dilator 4 and the introducer 6 will be described.
As shown in FIGS. 4 to 7, the dilator 4 is joined to a dilator body 8 formed with a tapered distal end portion 8 a for expanding the insertion port of the blood vessel and a base end portion of the dilator body 8. And a cap portion 10.

  As shown in FIGS. 4 and 6, the dilator main body 8 is constituted by a hollow tube, and a guide wire insertion hole 8 b is formed therein. As shown in FIG. 6, a dilator hub portion 12 and a cap portion 10 are joined to the base end portion of the dilator body 8 by means such as adhesion or fusion. The dilator body 8 is made of, for example, a tube made of fluororesin, polyamide, or polyethylene, and has an inner diameter of 0.5 to 2.0 mm, for example, and a wall thickness of 0.1 to 2.0 mm, for example.

  As shown in FIG. 4, the introducer 6 includes a sheath 14 that is inserted so that the distal end portion 8 a of the dilator main body 8 protrudes, and a sheath hub portion 16 that is joined to the proximal end portion of the sheath 14. The sheath 14 is configured by a hollow tube, and the dilator body 8 is inserted through the sheath 14. The length of the sheath 14 is designed so that the tapered tip 8a of the dilator body 8 protrudes from the tip.

  The sheath 14 is made of, for example, a tube made of fluororesin, polyurethane, or polyamide, and has an inner diameter of 1.0 to 5.0 mm, for example, and a wall thickness of 0.1 to 1.0 mm, for example.

  A sheath hub portion 16 is joined to the proximal end portion of the sheath 14 by means such as adhesion or fusion. A luer tube 20 is connected to the sheath hub portion 16. The luer tube 20 communicates with a gap between the sheath 14 and the dilator main body 8, and through this luer tube 20, blood suction, injection of a chemical solution such as heparin, and physiological saline can be performed.

  As shown in FIG. 5, the sheath hub portion 16 can be detachably fitted in a fitting space 22 formed inside the cap portion 10. In addition, in the present embodiment, the male screw portion 24 is formed on the outer periphery of the sheath hub portion 16, and the female screw portion 26 that engages with the male screw portion 24 is formed on the inner periphery of the cap portion 10.

  In the present embodiment, the cap portion 10 is made of a synthetic resin or an elastomer, and specifically, is made of polyurethane or polyvinyl chloride (PVC), nylon, natural rubber, polyethylene, polypropylene, styrene elastomer, or the like. It is. The sheath hub portion 16 is made of, for example, ABS, polyvinyl chloride (PVC), polyacetal, polyacrylonitrile, nylon, polyethylene (PE), polycarbonate (PC), or polypropylene (PP).

  As shown in FIG. 4, a medical valve body 40 is attached to the inside of the base end side of the sheath hub portion 16 of the introducer 6 according to the present embodiment.

  In this embodiment, as shown in FIGS. 1 to 3, the medical valve body 40 has a close-contact hole 46 into which a long insert such as a dilator 4 can be inserted while maintaining liquid tightness at the center thereof. It has a formed valve body 45. The valve body 45 has an inlet surface 41 on the side where the insert is inserted and an outlet surface 43 on the opposite side in the axial direction.

  The entrance surface 41 is formed with a concave taper surface 41a inclined toward the contact hole 46 and a flat surface 41b located on the outer periphery thereof. The flat surface 41 b is substantially perpendicular to the axis of the contact hole 46. The concave tapered surface 41a is located on the inner circumferential side of the first tapered surface 41a1 and on the outer circumferential side thereof, and the second inclined angle θ2 is smaller than the first inclined angle θ1 with respect to the flat surface 41b of the first tapered surface 41a2. A second tapered surface 41a2.

  A plurality of guide grooves 42 are integrally formed radially on the tapered surface 41a in the circumferential direction with the contact hole 46 as a center. As shown in FIG. 1, each guide groove 42 has a groove width wider at the outer peripheral portion 42 b than the inner peripheral portion 42 a and at the outer peripheral portion 42 b at the inner peripheral portion 42 a positioned around the contact hole 46. Compared to the guide groove 42, the guide groove 42 is close to the circumferential direction. In the inner peripheral part 42a and the outer peripheral part 42b of each guide groove 42, it is preferable that the groove end is rounded in a semicircular shape.

  As shown in FIG. 3, the groove depth of each guide groove 42 is formed so as to be deep at the outer peripheral portion 42b and shallow at the inner peripheral portion 42a. In particular, at the groove end of the inner peripheral portion 42a of each guide groove 42, the bottom of the groove 42 and the first tapered surface 41a1 intersect and are connected to the entrance of the contact hole 46. Although the maximum depth of each guide groove 42 with respect to the concave tapered surface 41 is not particularly limited, it is preferably 0.1 to 1 mm. The groove width of each guide groove 42 is determined according to the tip thinness of the dilator body 8 and the like, and 0.2 to 0.5 times the tip thinness is determined to be the maximum width of the guide groove 42. It is preferable.

  A convex taper surface 43 a corresponding to the concave taper surface 41 a of the inlet surface 41 is formed on the outlet surface 43 of the valve body 45. The inclination angle θ3 (FIG. 3A) of the convex tapered surface 43a with respect to the flat surface 41b is preferably the aforementioned inclination angle θ2 ± 10 degrees. The inclination angle θ4 (FIG. 3B) of the bottom of the guide groove 42 with respect to the flat surface 41b is preferably smaller than the above-described inclination angle θ2 and 5 degrees or more.

  Specifically, the inclination angle θ1 is preferably 15 to 25 degrees, and the inclination angle θ2 is preferably 5 to 10 degrees smaller than the inclination angle θ1.

  The close-contact hole 46 has an insertion hole 48 formed on the inlet surface 41 side of the valve body 40, and a cut slit 50 that is continuous with the bottom of the insertion hole 48. The slit-like slit 50 has a slit width that increases toward the exit surface 43 side. The exit surface 43 is provided with an exit-side recess 52 having an inner diameter corresponding to the slit width d2. The outlet side recess 52 is located at the top of the convex tapered surface formed on the outlet surface 43.

  In the present embodiment, the slit 50 is a cross-shaped slit as viewed from the plane side or the back side. The upper portion (inlet surface side) of the slit 50 can communicate with the bottom portion of the insertion hole 48, and the lower portion (outlet surface side) of the slit 50 can communicate with the bottom portion of the outlet side recess 52. ing. The cut width of the slit 50 is substantially the same as the inner diameter d1 of the insertion hole 48 on the insertion hole 48 side, and the cut width d2 on the outlet surface 43 side is about 1 to 5 times the inner diameter d1 of the insertion hole 48. The cut width is increased in a tapered shape toward the exit surface side.

  The cut width of the slit 50 may be the same width d1 in the thickness direction of the valve body 45 without being tapered. However, by making the cut cross section of the slit 50 widen toward the outlet face 43 of the valve body 45, the pressure of body fluid such as blood to be leaked can be narrowed from the wide cut cross section side of the slit 50. It acts on the cross-section side, closes the gap between the slit 50 and the insert (for example, the dilator 4) on the narrow cut cross-section side, and maintains good hemostatic properties.

  The inner diameter d1 of the insertion hole 48 shown in FIG. 2B is smaller than the outer diameter of the long insert inserted into the insertion hole 48 (generally, the diameter of the guide wire, the diameter of the catheter used, or the dilator diameter). It is preferable to design, and specifically, about 0.1 to 4.0 mm.

  The thickness t0 of the valve main body 45 constituting the valve body 40 shown in FIG. 3A is not particularly limited, but is determined so that the long insert can be smoothly inserted and has an appropriate sealing property. Specifically, it is about 0.5 to 5.0 mm. Although the inclination angles θ1 to θ3 of the tapered surfaces 4a1, 4a2, and 43a are determined so that the thickness t0 of the valve body 45 is substantially uniform between the outer peripheral portion and the inner peripheral portion, they are strictly the same thickness. It is not necessary, and may be different within a range of ± 1 mm, for example. Further, the thickness t0 of the valve main body 45 may be slightly reduced in the inner peripheral portion as compared with the outer peripheral portion.

  In the present embodiment, the axial depth of the insertion hole 48 is 10 to 30% of the thickness t0 of the valve body 45, and the axial depth of the outlet side recess 52 is 5 to 20%. The axial depth of 50 is a value obtained by subtracting the depth from the thickness t0 of the valve body 45.

  As shown in FIGS. 2B and 3A, in this embodiment, a leg portion 54 extending in the axial direction from the outlet surface 43 is integrally formed on the outer peripheral portion of the outlet surface 43 of the valve body 45. It is. The leg portion 54 may be provided continuously along the circumferential direction of the valve body 45 or may be provided intermittently.

  The leg portion 54 provided on the outlet surface 43 is provided corresponding to the flat surface 41b of the inlet surface 41, and the distance r3 from the center of the contact hole 46 to the inner peripheral surface of the leg portion 54 is, in this embodiment, It is preferable that the distance r1 is equal to or greater than the distance r1 from the center of the contact hole 46 to the outer peripheral end of the guide groove 42. However, the distance r1 from the center of the contact hole 46 to the outer peripheral end of the guide groove 42 may be formed larger than the distance r3 from the center of the contact hole 46 to the inner peripheral surface of the leg 54.

  The axial height h0 of the leg 54 is preferably 100 to 180% of the thickness t0 of the valve body 45. The radial width w0 of the leg portion 54 is preferably about 0.1 × d0 to 0.4 × d0, where the outer diameter of the valve body is d0 (2 × radius r0).

  In the present embodiment, the medical valve body 40 including the leg portion 54 and the valve main body 45 is integrally formed by using injection molding or the like. The material of the medical valve body 40 is not particularly limited. For example, it is composed of synthetic rubber such as natural rubber, butyl rubber, ethylene-propylene rubber, polybutadiene rubber, polyisoprene rubber, silicone rubber, polyurethane, fluorine rubber, preferably silicone rubber. Is done. The tapered surfaces 41a and 43a, the guide groove 42, the contact hole 46, and the leg portion 54 may be formed simultaneously with the molding of the valve body 40, or may be formed by machining after forming a disk-shaped molded body. good.

  In the present embodiment, the surface of the tapered surface 41a is preferably coated with a substance that reduces frictional resistance. It is preferable that the substance that reduces the frictional resistance is coated only on the surface of the tapered surface 41a. In this case, it is preferable that the elasticity of the members constituting the valve body is not lowered as compared with the case where the entire surface of the valve body is coated.

  The coating material for reducing the frictional resistance is not particularly limited, but includes tetrafluoroethylene polymer, tetrafluoroethylene-ethylene copolymer, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer, tetrafluoroethylene- Fluorine resins such as propylene copolymer, vinylidene fluoride-tetrafluoropropylene copolymer; vinylidene fluoride-hexafluoropropylene copolymer, vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene copolymer, Fluororubber such as vinylidene fluoride-tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer; polyurethane, polyparaxylylene and the like are exemplified. Silicone oil or the like may be applied to the entire surface of the medical valve body 40. This is to protect the valve body 40.

  As described above, the medical valve body 40 formed in this way is attached to the inside of the proximal end portion of the sheath hub portion 16 of the introducer 6 shown in FIG. 4, for example.

  In order to insert a catheter tube into a blood vessel using the introducer 6 having the medical valve element 40 according to the present embodiment, the following is performed. First, a puncture needle composed of an outer trocar (cannula) (not shown) and an inner trocar is inserted from above the patient's skin 30 shown in FIG. 7, and the distal end thereof is positioned in the blood vessel 32. Next, the inner needle is extracted while leaving the outer needle (cannula), and the guide wire 34 is inserted into the blood vessel 32 through the hole from which the inner needle has been extracted.

  Next, the outer needle is pulled out along the inserted guide wire 34, and then the guide wire 34 is passed through the insertion hole 8 b (see FIG. 6) of the dilator body 8, and along the guide wire 34, the introducer 6. The distal end portion of the catheter tube insertion tool in which the dilator 4 and the dilator 4 are integrated is inserted into the blood vessel insertion port 36. The state is shown in FIG.

  In order to integrate the dilator 4 into the introducer 6, in this embodiment, the dilator body 8 of the dilator 4 is inserted from the sheath hub portion 16 on the proximal end side of the introducer 6, and the tapered distal end portion 8 a of the dilator body 8 is inserted. Is protruded from the distal end of the sheath 14. Then, the cap portion 10 formed at the proximal end portion of the dilator 4 is attached to the outer periphery of the sheath hub portion 16 formed at the proximal end portion of the sheath 8. When the male screw portion 24 formed on the outer periphery of the sheath hub portion 16 is screwed to the female screw portion 26 formed on the inner periphery of the cap portion 10 shown in FIG. The relative movement in the direction and the rotation direction becomes impossible, and both are integrated.

  When the distal end of the catheter tube insertion tool composed of the integrated introducer 6 and dilator 4 is inserted into the blood vessel insertion port 36 as shown in FIG. 7, a tapered distal end formed at the distal end of the dilator 6 is formed. 8a pushes the insertion port 36 of the blood vessel. Further, if the distal end of the catheter tube insertion tool is pushed in, the distal end of the sheath 14 is also inserted into the blood vessel. Thereafter, the proximal end portion of the catheter tube insertion tool is operated, the engagement between the male screw portion 24 and the female screw portion 26 is released, and the cap portion 10 is removed from the sheath hub portion 16.

  Thereafter, when the cap portion 10 is pulled out together with the guide wire 34 from the proximal end side with respect to the sheath hub portion 16, the dilator body 8 and the guide wire 34 are pulled out from the inside of the sheath 14. Thereafter, the catheter tube is conveniently inserted into the blood vessel 32 by inserting the catheter tube into the introducer 6 from the proximal end side.

  In this embodiment, since the contact hole 46 formed in the medical valve body 40 is a combination of the insertion hole 48 and the slit 50, a long insert such as the dilator body 8 or the catheter tube is placed in the introducer 6. Even during the insertion, the blood flowing from the introducer tip side is well sealed by the medical valve body 40. That is, the insertion hole 48 is not hemostatic when the insert is not inserted into the insertion hole 48, but maintains hemostasis when the insert is inserted into the insertion hole 48.

  When the dilator 4 is removed from the introducer 6 and nothing is inserted into the medical valve body 40 until the catheter tube is inserted, since the slit 50 is closed, a good hemostatic action is obtained. Play.

  Therefore, in the medical valve body 40 and the introducer 6 having the medical valve body according to the present embodiment, hemostasis is good both in a state before inserting a long insert such as a catheter and in a state during insertion.

  Further, in the medical valve body 40 and the introducer 6 having the same according to the present embodiment, when the distal end portion 8a of the dilator body 8 is inserted into the contact hole 46 of the valve body 45, the distal end portion 8a of the dilator body 8 is It is guided to the sliding contact hole 46 along the guide groove 42 formed in the inlet surface 41 of the main body 45. Therefore, even if the front end portion 8a of the dilator body 8 is thinned, it is guided to the sliding contact hole 46 along the guide groove 42 without being crushed. For this reason, it becomes possible to make the front-end | tip part 8a of the dilator main-body part 8 thin, and the puncture resistance to the patient by the front-end | tip part 8a of the dilator main body 8 can be made small.

  When the dilator body 8 is further inserted into the contact hole 46 after the dilator body 8 is guided to the contact hole 46, a part of the inlet surface 41 located around the contact hole 46 is formed as shown in FIG. The dilator body 8 is in close contact with the outer periphery. However, as shown in FIGS. 1 to 3, since the guide grooves 42 are formed radially on the inlet surface 41 located around the contact hole 46, the resistance when the dilator body 8 is inserted and withdrawn. Is small and excellent in operability. Moreover, since the contact hole 46 is closed after the dilator body 8 is pulled out, the hemostasis is excellent.

  In the present embodiment, the inlet surface 41 of the valve body 45 is formed with a concave tapered surface 41a inclined toward the contact hole 46, and linear guide grooves 42 are formed radially on the concave tapered surface 41a. It is. For this reason, the concave groove 41a inclined toward the contact hole 46 is formed on the inlet surface 41 of the valve body 45, so that the tip 8a of the dilator body 8 is formed on the inlet surface of the valve body 45. It becomes easy to slide along 42 and guide to the contact hole 46 becomes easier.

  In the present embodiment, the groove depth of the guide groove 42 is deep at the outer peripheral portion and shallow at the inner peripheral portion. Therefore, when the front end portion 8a of the dilator main body 8 first contacts the outer peripheral portion of the inlet surface 41 of the valve main body 45, the front end portion 8a is easily guided from the outer peripheral portion toward the inner peripheral portion.

  In addition, a small outer diameter long insert such as a guide wire may be inserted into the close contact hole 46 of the valve body 45, or a large outer diameter long insert such as a catheter tube may be inserted. In either case, hemostasis is required, and low resistance during insertion and withdrawal is required. By forming the groove depth of the guide groove 42 deep at the outer peripheral portion and shallow at the inner peripheral portion, regardless of the outer diameter of the long insert, when inserting or withdrawing the insert, the hemostasis is not lowered. The effect of reducing the resistance is increased.

  Furthermore, in this embodiment, the convex taper surface 43a corresponding to the concave taper surface 41a is formed on the outlet surface 43 corresponding to the inlet surface 41 where the concave taper surface 41a is formed. By forming the convex taper surface 43a corresponding to the concave taper surface 41a, the thickness of the valve body 45 on which these are formed becomes substantially uniform between the outer peripheral portion and the inner peripheral portion, and contacts the outer periphery of the insert. The contact unevenness of the valve body 45 to be removed is eliminated, and the adhesion force becomes uniform.

  Furthermore, in this embodiment, the exit side recessed part 52 is provided in the part corresponding to the contact | adherence hole 46 located in the top part of the convex taper surface 43a. Therefore, the movement of the valve body 45 contacting the outer periphery of the insert becomes more flexible, and the contact resistance of the valve body 45 with respect to the insert when the insert is inserted or removed is lowered.

  Moreover, in this embodiment, the flat surface 41b is formed in the inlet surface 1 of the valve main body 45 located in the outer peripheral part of the concave taper surface 41a, and the exit of the valve main body 45 located in the outer peripheral part of the convex taper surface 43a Legs 54 are formed on the surface 43 so as to protrude in a direction opposite to the flat surface 41b. By forming the leg portion 54, it is possible to disperse the compressive force or tensile force generated on the outlet face 43 side of the valve body 45 when inserting or withdrawing an insert into the tight hole 46 of the valve body 45. . As a result, the resistance when inserting and withdrawing the insert can be further reduced.

  Furthermore, in this embodiment, the groove width of each guide groove 42 is wider at the outer peripheral portion 42b than the inner peripheral portion 42a, and the inner peripheral portion 42a located around the contact hole 46 is larger than the outer peripheral portion 42b. Thus, the guide groove 42 is close to the circumferential direction. Therefore, when the front end portion 8a of the dilator main body 8 first contacts the outer peripheral portion of the inlet surface 41 of the valve main body 45, the front end portion 8a is easily guided from the outer peripheral portion toward the inner peripheral portion. In addition, with this configuration, the effect of reducing resistance during insertion and withdrawal of the insert is great, without reducing hemostasis, regardless of the outer diameter of the long insert such as the dilator body 8. Become.

  The present invention is not limited to the above-described embodiment, and can be variously modified within the scope of the present invention. For example, in the present invention, the specific configuration of the contact hole 46 formed in the valve body is not limited to the combination of the insertion hole 48, the slit 50, and the outlet side recess 52, and can be variously modified.

  In the above-described embodiment, as shown in FIGS. 2 and 3, the boundary between the outlet surface 43 of the valve body 45 and the leg 54 has a depth in the thickness direction of the valve body 45 and extends in the circumferential direction. A continuous resistance relaxation groove 60 may be formed. The groove width of the resistance relaxation groove 60 is not particularly limited, but is 0.2 to 1.0 mm in the present embodiment. Further, the depth of the resistance relaxation groove 60 is not particularly limited, but is 0.1 to 0.5 mm in the present embodiment. By providing the resistance relaxation groove 60, when the dilator body 8 passes through the contact hole 46, the compressive force generated on the outlet surface 43 of the valve body 45 is relaxed, and a part of the valve body that contacts the dilator is more flexible. The contact resistance to the dilator can be further reduced.

  Furthermore, in embodiment mentioned above, although the medical valve body 40 was comprised with the single material, it is not limited to this, You may comprise with a several material layer.

4 ... Dilator 6 ... Introducer (Medical insertion aid)
DESCRIPTION OF SYMBOLS 8 ... Dilator main body 10 ... Cap part 14 ... Sheath 16 ... Sheath hub part 40 ... Medical valve body 41 ... Entrance surface 41a ... Concave taper surface 41a1 ... 1st taper surface 41a2 ... 2nd taper surface 41b ... Flat surface 42 ... Guide groove 42a ... Inner peripheral part 42b ... Outer peripheral part 43 ... Outlet surface 43a ... Convex taper surface 45 ... Valve body 46 ... Contact hole 48 ... Insertion hole 50 ... Slit 52 ... Outlet side concave part 54 ... Leg part 60 ... Resistance relaxation groove

Claims (4)

A medical valve body, a sheath hub portion in which the medical valve body is mounted, and a sheath to which a proximal end portion is joined to the sheath hub portion, and for inserting a long insert into a blood vessel Insertion aid for
The medical valve body is
There constituted by a valve body having the elongated insert insertion and extraction capable sticking groove elasticity which is formed while maintaining the liquid-tightness so as to penetrate toward the exit surface from the inlet face of the valve body ,
A concave taper surface inclined toward the contact hole is formed on the inlet surface of the valve body on the side where the long insert is inserted, and the concave taper surface has a periphery around the contact hole. A plurality of guide grooves are formed radially in the direction,
The groove depth of the guide groove is deep at the outer peripheral portion and shallow at the inner peripheral portion,
The guide groove is wider in the outer peripheral portion than the inner peripheral portion and in the inner peripheral portion located around the contact hole in the circumferential direction compared to the outer peripheral portion. A medical insertion aid characterized by proximity. The medical insertion assistance tool according to claim 1, wherein a convex taper surface corresponding to the concave taper surface is formed on an outlet surface corresponding to the inlet surface on which the concave taper surface is formed. A flat surface is formed on the inlet surface of the valve body located on the outer peripheral portion of the concave tapered surface,
The medical insertion assisting tool according to claim 2, wherein a leg portion protruding in a direction opposite to the flat surface is formed on an outlet surface of the valve body located on an outer peripheral portion of the convex tapered surface. A flat surface is formed on the inlet surface of the valve body located on the outer peripheral portion of the concave tapered surface,
The concave tapered surface has a first tapered surface located on the inner peripheral side and a second tapered surface located on the outer peripheral side,
The medical insertion according to any one of claims 1 to 3, wherein a first inclination angle θ1 with respect to the flat surface of the first taper surface and a second inclination angle θ2 with respect to the flat surface of the second taper surface satisfy θ2 <θ1. Auxiliary tool .

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