JP2011072435A - Manufacturing method of valve element, introducer sheath, and introducer assembly - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a method of manufacturing a valve element mounted on a medical tool for sterilizing the inside of the medical tool even if the medical tool is sterilized under a state of being inserted with a longitudinal member, an introducer sheath having the valve element, and the introducer assembly having the introducer. <P>SOLUTION: A valve element 6A is used by mounting on an introducer used for introducing a dilator 10 in a living body and shaped into a disk, composed of an elastic material. The valve element 6A, formed to reach from the upper surface 68 to the lower surface 69, has an inserting hole 61A where the dilator 10 is inserted and a side slit 66A which is formed to reach from the side surface 67 to the inserting hole 61A to communicate with the inserting hole 61A, and the dilator 10 is positioned to the inserting hole 61A through the side slit 66A. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a valve body, an introducer sheath, and a method for manufacturing an introducer assembly.

  An introducer is used to introduce a long member (typically “dilator”) such as a dilator, a catheter, a guide wire, or the like into a living body. As this introducer, for example, the one described in Patent Document 1 is known.

  The introducer described in Patent Document 1 has a cylindrical hub and a sheath tube connected to the tip of the hub. In addition, a valve body made of an elastic material is attached to the base end portion of the hub. This valve body has a film shape and has a plurality of slits penetrating in the thickness direction. When inserting the dilator into the introducer, the insertion operation is performed through the slit of the valve body. Then, the introducer assembly in an assembled state in which the dilator is inserted into the introducer and assembled is introduced into the living body.

  By the way, the introducer and the dilator need to be sterilized. However, for example, when autoclave sterilization is performed in the assembled state, the valve body may prevent high-pressure steam from flowing into the introducer. For this reason, it is difficult for high-pressure steam to reach the lumen of the hub, the portion inserted into the introducer of the dilator, and the like, and there is a problem that these portions are not sufficiently sterilized. It is also known that if the sterilization is performed with the dilator inserted through the valve body, the valve body is damaged (deteriorates).

Japanese Patent Publication No. 2-948

  An object of the present invention is to provide a valve body to be mounted on a medical device so that the sterilization process can be surely extended to the inside of the medical device even if the sterilization processing is performed with the elongated member inserted in the medical device. It is an object of the present invention to provide an introducer sheath including a valve body and a method of manufacturing an introducer assembly including such an introducer.

Such an object is achieved by the present inventions (1) to (15) below.
(1) A valve body having a plate shape or a column shape that is used by being attached to a medical device used when a long member is introduced into a living body, and is made of an elastic material,
An insertion hole formed so as to reach the other surface from one surface, and through which the elongated member is inserted;
It is formed so as to reach the insertion hole from the side surface, and has a side slit communicating with the insertion hole,
The valve body, wherein the elongated member can be positioned in the insertion hole through the side slit.

  (2) The said side slit is a valve body as described in said (1) currently formed in parallel with the central axis of the said valve body.

  (3) The valve body according to (2), wherein the valve body is attached to the medical device in a state of being compressed toward the central axis.

  (4) The valve element according to (1), wherein the side slit is formed to be inclined with respect to the central axis of the valve element.

  (5) In the side slit, the portion in which the one surface is cut and the portion in which the other surface is cut are located on opposite sides through the insertion hole in plan view. The valve body as described in (4).

  (6) The valve body according to (4) or (5), wherein the valve body is attached to the medical device in a state where the valve body is compressed in the central axis direction or compressed toward the central axis.

  (7) The valve element according to any one of (1) to (6), wherein the insertion hole is configured by a small hole.

  (8) The valve element according to any one of (1) to (6), wherein the insertion hole includes a small hole and a plurality of slits extending radially from the small hole.

  (9) The valve element according to (7) or (8), wherein the insertion hole has a tapered portion whose inner diameter gradually increases toward one side.

  (10) The valve body according to any one of (1) to (6), wherein the insertion hole includes at least one slit.

(11) The insertion hole includes a first slit that reaches only the one surface, and a second slit that reaches only the other surface and intersects the first slit inside.
The said side slit is a valve body as described in said (10) connected to the cross | intersection part of a said 1st slit and a said 2nd slit.

(12) The insertion hole is configured by a first slit and a second slit that reach the other surface from the one surface and intersect each other,
The valve body according to (10), wherein the side slit is connected to at least one of the first slit and the second slit.

  (13) The valve element according to any one of (1) to (12), wherein the long member is a dilator, a catheter, or a guide wire.

(14) The valve body according to any one of (1) to (13),
A hub having a tubular shape in which the valve body is mounted;
An introducer sheath, comprising: a sheath tube fixed to a distal end portion of the hub and communicating with a lumen portion of the hub.

(15) A method for manufacturing an introducer assembly comprising the introducer sheath according to (14) above and a dilator that is inserted into the introducer sheath and assembled.
A temporary assembly step in which the dilator is collectively inserted into the hub and the sheath tube in a temporary assembly state in a state where the valve body is not yet mounted on the hub;
A sterilization step of sterilizing the hub, the sheath tube and the dilator in the temporarily assembled state;
A valve body mounting step in which the dilator is positioned in the insertion hole through the side slit, the dilator is inserted through the insertion hole, and the valve body is mounted on the hub. A method of manufacturing an introducer assembly.

  According to the present invention, it is possible to insert a long member into a medical device in a state where a valve body is not yet mounted. When the sterilization process is performed in this state, the sterilization process reliably reaches the inside of the medical device. The valve body can be attached to a sterilized medical device.

  Also, when the side slit is formed parallel to the central axis of the valve body or when it is formed inclined with respect to the central axis of the valve body, the valve body is pulled in the opposite direction via the side slit. The side slit can be widened with a simple operation. Therefore, the long member can be easily positioned in the insertion hole through the widened side slit. Thereby, when mounting | wearing a valve body with respect to the medical device in the state where the valve body has not yet been mounted | worn, the mounting operation can be performed rapidly.

It is a fragmentary longitudinal cross-section which shows the introducer assembly provided with the introducer (valve body) of this invention. It is a perspective view which shows 1st Embodiment of the valve body of this invention. It is a top view which shows the state which mounted | wore the introducer with the valve body shown in FIG. It is a perspective view which shows 2nd Embodiment of the valve body of this invention. It is a side view which shows the state which mounted | wore the introducer with the valve body shown in FIG. It is a top view of the valve body shown in FIG. It is a side view which shows 3rd Embodiment of the valve body of this invention. It is a top view which shows 4th Embodiment of the valve body of this invention. It is a top view which shows 5th Embodiment of the valve body of this invention. It is a perspective view which shows 6th Embodiment of the valve body of this invention. It is a perspective view which shows 7th Embodiment of the valve body of this invention. It is a figure which shows the process of manufacturing the introducer assembly shown in FIG. 1 in order. It is a figure which shows the process of manufacturing the introducer assembly shown in FIG. 1 in order. It is a figure which shows the process of manufacturing the introducer assembly shown in FIG. 1 in order. It is a figure which shows the process of manufacturing the introducer assembly shown in FIG. 1 in order.

  Hereinafter, the manufacturing method of the valve body, introducer sheath, and introducer assembly of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

<First Embodiment>
FIG. 1 is a partial longitudinal sectional view showing an introducer assembly provided with an introducer (valve element) according to the present invention, FIG. 2 is a perspective view showing a first embodiment of the valve element according to the present invention, and FIG. FIG. 12 to FIG. 15 are views sequentially illustrating steps for manufacturing the introducer assembly shown in FIG. 1. In the following, for convenience of explanation, the upper side of FIGS. 1, 2, and 12 to 15 (the same applies to FIGS. 4, 5, 7, 10, and 11) is referred to as “base end”, “ The “upper” or “upper” is referred to as “tip”, “lower” or “lower”.

  An introducer assembly (introducer kit) 100 shown in FIG. 1 includes an introducer (introducer sheath) 1 and a dilator (expansion pipe) 10 and is assembled by inserting the dilator 10 into the introducer 1. is there. Hereinafter, the state shown in FIG. 1 is referred to as an “assembled state”.

  The introducer 1 is a medical device used to introduce a long member used for medical treatment such as a guide wire or a catheter 11 in addition to the dilator 10 into a living body (for example, a blood vessel or the like). The dilator 10 is used by inserting the sheath tube 4 of the introducer 1 into the sheath tube 4 in order to facilitate introduction into the living body.

  The dilator 10 includes a dilator main body 103 configured by a flexible tube (tube). This dilator 10 is inserted into the introducer 1 and inserted (introduced) into the living body in a state of being fixed to the introducer 1. Further, in the dilator 10, for example, the tip 101 of the dilator 10 is reduced in diameter toward the tip in order to facilitate introduction into the blood vessel. Such a dilator 10 is removed from the introducer 1 after the dilator body 103 is inserted into the living body (blood vessel) together with the sheath tube 4. Thereafter, the catheter 11 or the guide wire is inserted from the through hole 253 of the hub 2.

  The introducer 1 includes a hub 2, a tubular sheath tube 4 fixed to the distal end side of the hub 2, and a valve body 6 </ b> A attached to the inside of the hub 2.

  The hub 2 includes a hub main body 24 formed of a tubular body and a cap 25 attached to a proximal end portion of the hub main body 24.

  A side port (connecting portion) 21 projecting sideways is provided on the outer peripheral portion of the hub body 24 in the middle of the longitudinal direction. The side port 21 has a tubular shape, and a hollow portion (inside) 211 communicates with the lumen portion 241 of the hub body 24. For example, one end of a flexible tube 8 made of polyvinyl chloride is liquid-tightly connected to the side port 21.

  Further, a concave portion (groove) 22 is formed in the outer peripheral portion of the proximal end of the hub body 24 along the circumferential direction thereof.

  The cap 25 includes a top plate 251 and a wall portion 252 erected from the edge of the top plate 251.

  The top plate 251 is formed with a through-hole 253 that penetrates in the center in the thickness direction. A long member such as the dilator 10 can be inserted into the introducer 1 through the through hole 253.

  A ring-shaped protrusion 254 is formed on the inner peripheral portion of the wall portion 252 along the circumferential direction. The protrusion 254 is inserted into the recess 22 of the hub body 24 when the cap 25 is attached to the hub body 24. Thereby, it is possible to prevent the cap 25 from being detached from the hub body 24.

  Further, in a state where the cap 25 is mounted on the hub body 24, a gap (lumen portion) is formed between the cap 25 and the hub body 24, and the valve body 6A can be installed in this gap. The installed valve body 6A is sandwiched between the top plate 251 of the cap 25 and the base end face 23 of the hub body 24, and is thus securely fixed to the hub 2.

  The constituent material of the hub 2 is not particularly limited, and examples thereof include polyolefins such as polyethylene and polypropylene, polyamide, polycarbonate, and polystyrene.

  A sheath tube 4 is disposed on the distal end side of the hub 2. The sheath tube 4 is a member introduced into the living body, and is configured by a thin tubular member. The base end portion of the sheath tube 4 is fitted into the distal end portion of the hub 2 and communicates with the lumen portion 241 of the hub 2 (hub body 24).

  As a constituent material of the sheath tube 4, for example, a resin material having a relatively high rigidity can be used. Particularly, high density polyethylene, polyolefin such as polypropylene, polyamide such as nylon 66, polyurethane, polyethylene terephthalate, poly Preference is given to those mainly comprising at least one selected from the group consisting of fluororesins such as polyesters such as butylene terephthalate and polycyclohexane terephthalate, polytetrafluoroethylene, and ethylene-tetrafluoroethylene copolymers.

  A valve body 6 </ b> A is attached to the proximal end portion of the hub 2. As shown in FIG. 2, the valve body 6 </ b> A is configured by an elastic body having a disk shape (film shape). The elastic material constituting the valve body 6A is not particularly limited. For example, natural rubber or various synthetic rubbers such as isoprene rubber, silicone rubber, urethane rubber, styrene-butadiene rubber, fluorine rubber, and acrylic rubber, polyamide Examples thereof include elastic materials such as various thermoplastic elastomers such as polyester and polyester.

  As shown in FIGS. 2 and 3, the valve body 6 </ b> A has an insertion hole 61 </ b> A formed at the center thereof and a side slit 66 </ b> A formed at the side surface 67.

  61 A of insertion holes are comprised by the small hole (pinhole) formed so that it might reach | attain the lower surface (the other surface) 69 from the upper surface (one surface) 68 of the valve body 6A. The insertion hole 61A is a portion through which the dilator 10 is inserted in the assembled state.

  The insertion hole 61A is set in a natural state where no external force is applied, and has an inner diameter that is, for example, substantially the same as or slightly smaller than the maximum outer diameter of the dilator body 103 of the dilator 10. When the valve body 6A is attached to the hub 2, the valve body 6A is compressed toward the central axis O (see FIG. 3), and the insertion hole 61A is closed. Thereby, the through-hole 253 of the hub 2 is liquid-tightly sealed. Therefore, for example, the sterilized state of the lumen 241 of the hub 2 can be maintained, or the introducer assembly 100 is placed in a living body. In addition, leakage of blood flowing back through the sheath tube 4 can be prevented.

  In the assembled state, the insertion hole 61 </ b> A is in an open state, but the inner peripheral surface 611 of the insertion hole 61 </ b> A becomes the dilator of the dilator 10 due to the synergistic effect of its own restoring force (elastic force) and the compression force from the hub 2. It adheres to the outer peripheral surface 102 of the main body 103 in a liquid-tight manner. Thus, as in the case where the insertion hole 61A is in the closed state, the sterilized state is maintained and the blood leakage is prevented.

  Thus, the insertion hole 61A can be opened and closed as the dilator 10 is inserted / removed.

  As shown in FIG. 2 (also in FIG. 3), the side slit 66A is formed so as to reach from the side 67 to the insertion hole 61A. Further, the side slit 66A cuts the upper surface 68, has an upper cut portion 662, cuts the lower surface 69, and has a lower cut portion 663. The side slit 66A thus formed communicates with the insertion hole 61A.

  In the present embodiment, the side slit 66A is formed to be parallel to the central axis O of the valve body 6A in a side view, that is, to coincide with a line where the distance between the side surface 67 and the insertion hole 61A is the shortest. In the natural state, the inner surfaces 661 facing each other of the side slits 66A are in contact with (in close contact with) each other. Thereby, side slit 66A will be in a closed state.

  As shown in FIG. 14, when the valve body 6A is pulled in a direction in which the inner surfaces 661 are separated from each other (in the direction of arrow A in the drawing), the side slit 66A is opened. The dilator 10 can be positioned in the insertion hole 61A through the open side slit 66A. And if the said tension | pulling force with respect to 6 A of valve bodies is cancelled | released, it can be set as the state by which the dilator 10 was penetrated through the penetration hole 61A, ie, the valve body 6A was mounted in the outer peripheral part of the dilator main body 103 of the dilator 10 ( FIG. 15). In the method of manufacturing the introducer assembly 100 described later, the valve body 6A goes through a temporary mounting state in which the valve body 6A is mounted on the dilator body 103. In this temporary mounting state, the mounting operation can be easily performed by a simple operation of forcibly opening the side slit 66A and pushing the valve body 6A toward the dilator 10 as described above. .

  Further, as described above, the valve body 6A is attached to the hub 2 in a compressed state toward the central axis O (see FIG. 3). As a result, the inner surfaces 661 of the side slits 66A are firmly and tightly adhered to each other, so that the side slits 66A are surely closed. Thereby, it is possible to prevent blood from leaking from the side slit 66A.

  Next, a method for manufacturing the introducer assembly 100 will be described with reference to FIGS. The method for manufacturing the introducer assembly 100 includes a preparation process, a temporary assembly process, a sterilization process, and a valve body mounting process.

[1] Preparation Step First, as shown in FIG. 12, an introducer 1 and a dilator 10 are prepared. In the introducer 1, the hub 2 is in a state where the cap 25 is removed from the hub body 24 and the valve body 6A is not yet mounted. Hereinafter, the introducer 1 in this state is referred to as “introducer 1 ′ with no valve element mounted”.

[2] Temporary Assembly Step As shown in FIG. 12, the dilator 10 is inserted into the hub body 24 of the introducer 1 ′ from which the valve body is not mounted from the base end side. This insertion operation is performed until the distal end portion 101 of the dilator 10 protrudes from the sheath tube 4 of the introducer 1 ′ to which the valve element is not mounted.

  By such an operation, the dilator 10 is temporarily inserted into the hub main body 24 and the sheath tube 4 of the introducer 1 ′ without the valve element (see FIG. 13).

[3] Sterilization Step Next, in the temporarily assembled state shown in FIG. 13, sterilization is performed on the introducer 1 ′ (the hub main body 24 and the sheath tube 4) and the dilator 10 that are not attached to the valve body. At this time, the cap 25 and the valve body 6A attached to the hub body 24 are similarly sterilized. As a sterilization method, for example, autoclave sterilization is used. In autoclave sterilization, sterilization can be performed with high-pressure steam. Each of these is sterilized in a separate package.

  The introducer 1 ′ without the valve element is not sealed at the base end of the hub 2 by the valve element 6 </ b> A, and therefore, high-pressure steam can pass through the inside from the front end to the base end. As a result, even if sterilization is performed in a temporarily assembled state (with the dilator 10 inserted), the high-pressure steam spreads throughout the inside of the introducer 1 ′ without the valve element (and), and therefore the inside and The inserted dilator 10 can be sterilized sufficiently and reliably.

  On the other hand, since the cap 25 and the valve body 6A are sterilized individually (independently), the degree of sterilization is sufficient. In addition, it is known that when sterilization is performed with the dilator 10 inserted into the valve body 6A, the valve body 6A is damaged (deteriorates). However, this manufacturing method can also eliminate such problems. it can.

[4] Valve body attachment process After completion of sterilization, the temporarily unassembled introducer 1 ', the cap 25, and the valve body 6A are moved into an isolator (not shown) in an aseptic environment.

  As shown in FIG. 14, the valve body 6 </ b> A is mounted on the dilator 10 inserted in the introducer 1 ′ without mounting the valve body. Thereby, it will be in a temporary mounting state. This operation is performed by forcibly opening the side slit 66A and pushing the valve body 6A toward the dilator 10 as described above.

  Then, as shown in FIG. 15, the lower surface 69 of the valve body 6 </ b> A is brought into contact with the base end surface 23 of the hub body 24, and the cap 25 is attached to the hub body 24. As a result, the introducer 1 has the valve body 6A fixed (attached) to the hub 2. Moreover, since the dilator 10 is still inserted in the introducer 1, the introducer assembly 100 in an assembled state is completed.

  In the procedure, the introducer assembly 100 can be used in the assembled state. Thereby, a quick procedure (treatment) can be performed on the patient.

  In addition, as a sterilization method in the sterilization process, in addition to autoclave sterilization, for example, gas sterilization using a sterilizing gas such as hydrogen peroxide or EOG (ethylene oxide gas), irradiation by radiation such as γ-rays or electron radiation Radiation sterilization or the like can be used.

Second Embodiment
4 is a perspective view showing a second embodiment of the valve body of the present invention, FIG. 5 is a side view showing a state where the valve body shown in FIG. 4 is mounted on an introducer, and FIG. 6 is a valve shown in FIG. It is a top view of a body.

  Hereinafter, the second embodiment of the manufacturing method of the valve body, the introducer sheath and the introducer assembly of the present invention will be described with reference to these drawings. Description of similar matters is omitted.

  The present embodiment is the same as the first embodiment except that the shape of the side slits is different.

  In the valve body 6B shown in FIGS. 4 and 5, the side slit 66B is formed to be inclined with respect to the central axis O of the valve body 6B in a side view.

  In order to place the valve body 6B in a temporary mounting state in which the valve body 6B is mounted on the outer peripheral portion of the dilator body 103 of the dilator 10, first, the valve body 6B is placed in opposite directions (for example, the vertical direction in FIG. 5) via the side slit 66B. Pulling the inner surfaces 661 apart from each other. Thereby, side slit 66B will be in an open state. Then, with the dilator body 103 of the dilator 10 inclined in the same direction as the side slit 66B, the dilator body 103 is inserted into the side slit 66B. As the dilator body 103 approaches the insertion hole 61A, the posture of the dilator body 103 is changed so as to be parallel to the central axis O. Thereby, the dilator main body 103 is located in the insertion hole 61A, and is in a temporarily mounted state.

  Further, the side slit 66B occupies a half circumference of the side surface 67 of the valve body 6B. For this reason, in the plan view shown in FIG. 6, the side slit 66B has an angle θ of 180 ° formed by the upper cut portion 662 cutting the upper surface 68 and the lower cut portion 663 cutting the lower surface 69. ing. In other words, in the plan view shown in FIG. 6, in the side slit 66B, the upper cut portion 662 and the lower cut portion 663 are located on the opposite sides via the insertion hole 61A.

  In the side slit 66B formed in this way, the side slit 66B can be sufficiently opened when the temporary mounting state is set, and therefore the temporary mounting operation can be easily performed.

  The angle θ is 180 ° in the present embodiment, but is not limited to this, and may be any angle from 0 to 180 °, for example. Further, the angle of the side slit 66B with respect to the central axis of the dilator main body 103 (dilator 10) is, for example, larger than 0 ° and smaller than 90 ° as long as the dilator main body 103 can be inserted into the side slit 66B. ~ 70 °.

  Further, as shown in FIG. 5, in the state in which the valve body 6B is mounted on the hub 2, the valve body 6B is sandwiched between the hub body 24 and the cap 25 as described above, and therefore, in the direction of the central axis O. Compressed. As a result, the inner surfaces 661 of the side slits 66B are firmly and tightly adhered to each other, so that the side slits 66B are surely closed. Thereby, it is possible to prevent blood from leaking from the side slit 66B.

<Third Embodiment>
FIG. 7 is a side view showing a third embodiment of the valve body of the present invention.

Hereinafter, a third embodiment of the valve body, the introducer sheath, and the introducer assembly manufacturing method of the present invention will be described with reference to this drawing. The description of items is omitted.
This embodiment is the same as the second embodiment except that the shape of the insertion hole is different.

  In the valve body 6C shown in FIG. 7, a tapered diameter-enlarged portion (tapered portion) 612 whose inner diameter gradually increases upward is formed at the upper portion of the insertion hole 61C. The maximum inner diameter of the expanded diameter portion 612 is preferably larger than the outer diameter of the distal end 111 of the catheter 11, for example.

  Since the enlarged diameter portion 612 is formed, when the catheter 11 is inserted into the valve body 6C from which the dilator 10 has been removed, the distal end 111 of the catheter 11 is guided to the enlarged diameter portion 612 (see FIG. 7). 11 is easily and reliably inserted into the insertion hole 61C.

  The enlarged diameter portion 612 is not limited to the one whose inner diameter is gradually increased, and for example, the inner diameter may be constant.

<Fourth embodiment>
FIG. 8 is a plan view showing a fourth embodiment of the valve body of the present invention.

  Hereinafter, the fourth embodiment of the manufacturing method of the valve body, the introducer sheath and the introducer assembly of the present invention will be described with reference to this figure. The description of items is omitted.

  This embodiment is the same as the second embodiment except that the configuration (shape) of the insertion hole is different.

  In the valve body 6D shown in FIG. 8, auxiliary slits (slits) 613a, 613b, and 613c extending radially in a plan view are formed in the insertion hole 61D. These auxiliary slits 613a to 613c are arranged at equiangular intervals around the central axis O. Further, each of the auxiliary slits 613a to 613c penetrates from the upper surface 68 to the lower surface 69 of the valve body 6D.

  In the valve body 6D, the insertion hole 61D is easily opened by the amount of the auxiliary slits 613a to 613c. Thereby, when inserting the catheter 11 or the guide wire, the operation can be easily performed, and when the temporary attachment state is set, the dilator 10 can be easily positioned in the insertion hole 61D.

  The lengths of the auxiliary slits 613a to 613c are the same in the illustrated configuration, but are not limited thereto and may be different from each other.

  In addition, the number of auxiliary slits formed is three in the illustrated configuration, but is not limited thereto, and may be two or four or more, for example.

<Fifth Embodiment>
FIG. 9 is a plan view showing a fifth embodiment of the valve body of the present invention.

  Hereinafter, the fifth embodiment of the manufacturing method of the valve body, the introducer sheath and the introducer assembly of the present invention will be described with reference to this figure. The description of items is omitted.

  This embodiment is the same as the fourth embodiment except that the number of auxiliary slits is different.

  In the valve body 6E shown in FIG. 9, auxiliary slits 614a, 614b, 615a, 615b extending radially in a plan view are formed in the insertion hole 61E.

  The auxiliary slits 614a and 614b are slits that reach only the upper surface 68 from the inside of the valve body 6E. The auxiliary slit 614a and the auxiliary slit 614b are arranged on opposite sides with respect to the central axis O.

  The auxiliary slits 615a and 615b are slits that reach only the lower surface 69 from the inside of the valve body 6E. The auxiliary slit 615a and the auxiliary slit 615b are arranged on opposite sides with respect to the central axis O.

  Further, the auxiliary slits 614a, 614b, 615a, 615b are alternately arranged around the central axis O in plan view. That is, in the valve body 6E, the auxiliary slits 614a, 615a, 614b, and 615b are arranged in the clockwise direction around the central axis O.

  In the valve body 6E having such a configuration, the insertion hole 61E is easily opened by the amount of the auxiliary slits 614a, 614b, 615a, 615b.

  The depths of the auxiliary slits 614a, 614b, 615a, 615b may be the same or different.

  Further, the number of slits reaching only the upper surface 68 and the number of slits reaching only the lower surface 69 are the same in the illustrated configuration, but are not limited thereto, and may be different. When the numbers are different from each other, it is preferable that the number of slits reaching only the upper surface 68 is larger than the number of slits reaching only the lower surface 69.

<Sixth Embodiment>
FIG. 10 is a perspective view showing a sixth embodiment of the valve body of the present invention.

Hereinafter, the sixth embodiment of the manufacturing method of the valve body, the introducer sheath and the introducer assembly of the present invention will be described with reference to this figure. However, the difference from the above-described embodiment will be mainly described and the same. The description of items is omitted.
This embodiment is the same as the first embodiment except that the shape of the insertion hole is different.

  In the valve body 6F shown in FIG. 10, the insertion hole 61F is composed of a first slit 62a and a second slit 63a that form a single character in a plan view.

  The first slit 62 a is a slit that reaches only the upper surface 68. Further, the second slit 63 a is a slit that reaches only the lower surface 69. The second slit 63a partially intersects the first slit 62a inside the valve body 6F. In the configuration shown in FIG. 10, the first slit 62a and the second slit 63a intersect in a cross shape, that is, the intersecting angle of both the slits 62a and 63a is 90 °. The intersection angle is not limited to 90 °.

  In the valve body 6F having such a configuration, for example, when the dilator 10 is removed from the valve body 6F (introducer 1), the first slit 62a and the second slit 63a have self-occlusion properties, that is, their elasticity. To instantly restore the original shape and close it securely. Thereby, the liquid tightness of the valve body 6F is exhibited, and the leakage of blood is prevented.

  The side slit 66A is connected to the intersection 64 of the first slit 62a and the second slit 63a. Thereby, when it is set as a temporary mounting state, the dilator 10 inserted from the side slit 66A can be quickly positioned in the insertion hole 61F.

  The number of slits forming the insertion hole 61F is two, but is not limited thereto, and may be, for example, one or three or more.

<Seventh embodiment>
FIG. 11 is a perspective view showing a seventh embodiment of the valve body of the present invention.

  Hereinafter, the seventh embodiment of the manufacturing method of the valve body, the introducer sheath and the introducer assembly of the present invention will be described with reference to this figure. The description of items is omitted.

  This embodiment is the same as the sixth embodiment except that the first slit and the second slit are formed differently.

  In the valve body 6G shown in FIG. 11, the insertion hole 61G is configured by a first slit 62b and a second slit 63b that penetrate from the upper surface 68 to the lower surface 69 of the valve body 6G (reach the lower surface 69 from the upper surface 68). Has been.

  The side slit 66A is connected to the middle of the first slit 62b. Thereby, for example, the length of the side slit 66A can be made shorter than the length of the side slit 66A of the fifth embodiment, and accordingly, the time for forming the side slit 66A can be shortened accordingly. .

  The side slit 66A is connected to the middle of the first slit 62b in the illustrated configuration, but is not limited thereto, and may be connected to the end of the first slit 62b, for example.

  The side slit 66A is connected to one of the first slit 62b and the second slit 63b in the configuration shown in the drawing, but is not limited to this, and may be connected to the intersection 64, for example.

  As mentioned above, although the embodiment of illustration showed the manufacturing method of the valve body, introducer sheath, and introducer assembly of this invention, this invention is not limited to this, A valve body and introducer sheath are comprised. Each part to be replaced can be replaced with one having any configuration capable of performing the same function. Moreover, arbitrary components may be added.

  Moreover, the manufacturing method of the valve body, introducer sheath, and introducer assembly of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

  In addition, the valve body has a plate shape in each of the embodiments described above, but is not limited thereto, and may be, for example, a columnar shape (a columnar shape or a prismatic shape).

  In the introducer, a plate-like member made of an elastic material may be installed (inside) on the top plate of the cap attached to the hub body. When the cap is mounted on the hub body, the plate-like member overlaps the valve body, and the valve body is clamped more firmly. As a result, the valve body is more liquid-tightly attached to the hub.

100 Introducer assembly (Introducer kit)
1 Introducer (Introducer sheath)
1 'Introducer without valve body 2 Hub 21 Side port 211 Hollow part 22 Recessed part (groove)
23 Base end face 24 Hub body 241 Lumen part 25 Cap 251 Top plate 252 Wall part 253 Through hole 254 Projection part 4 Sheath tube 6A, 6B, 6C, 6D, 6E, 6F, 6G Valve body 61A, 61C, 61D, 61E, 61F, 61G Insertion hole 611 Inner peripheral surface 612 Large diameter part (taper part)
613a, 613b, 613c, 614a, 614b, 615a, 615b Auxiliary slit (slit)
62a, 62b First slit 63a, 63b Second slit 64 Intersection 66A, 66B Side slit 661 Inner surface 662 Upper cut portion 663 Lower cut portion 67 Side surface 68 Upper surface (one surface)
69 Bottom (the other side)
8 Tube 10 Dilator (expansion tube)
DESCRIPTION OF SYMBOLS 101 Tip part 102 Outer peripheral surface 103 Dilator main body 11 Catheter 111 Tip O Central axis θ angle

Claims (15)

It is used by being attached to a medical device used when a long member is introduced into a living body, and is a valve body having a plate shape or a column shape made of an elastic material,
An insertion hole formed so as to reach the other surface from one surface, and through which the elongated member is inserted;
It is formed so as to reach the insertion hole from the side surface, and has a side slit communicating with the insertion hole,
The valve body, wherein the elongated member can be positioned in the insertion hole through the side slit.   The said side slit is a valve body of Claim 1 currently formed in parallel with the central axis of the said valve body.   The valve body according to claim 2, wherein the valve body is attached to the medical device in a state of being compressed toward the central axis.   The valve body according to claim 1, wherein the side slit is formed to be inclined with respect to a central axis of the valve body.   5. The side slit has a portion in which the one surface is cut and a portion in which the other surface is cut, which are located on the opposite sides through the insertion hole in plan view. The valve body described.   The valve body according to claim 4 or 5, wherein the valve body is attached to the medical device in a state of being compressed in the direction of the central axis or being compressed toward the central axis.   The valve body according to any one of claims 1 to 6, wherein the insertion hole is formed of a small hole.   The valve body according to any one of claims 1 to 6, wherein the insertion hole includes a small hole and a plurality of slits extending radially from the small hole.   The valve body according to claim 7 or 8, wherein the insertion hole has a tapered portion whose inner diameter gradually increases toward one side.   The valve body according to any one of claims 1 to 6, wherein the insertion hole includes at least one slit. The insertion hole is composed of a first slit that reaches only the one surface, and a second slit that reaches only the other surface and intersects the first slit inside,
The valve element according to claim 10, wherein the side slit is connected to an intersecting portion between the first slit and the second slit. The insertion hole is composed of a first slit and a second slit that reach the other surface from the one surface and intersect each other,
The valve element according to claim 10, wherein the side slit is connected to at least one of the first slit and the second slit.   The valve body according to claim 1, wherein the elongated member is a dilator, a catheter, or a guide wire. The valve body according to any one of claims 1 to 13,
A hub having a tubular shape in which the valve body is mounted;
An introducer sheath, comprising: a sheath tube fixed to a distal end portion of the hub and communicating with a lumen portion of the hub. A method of manufacturing an introducer assembly comprising the introducer sheath of claim 14 and a dilator that is inserted into the introducer sheath and assembled.
A temporary assembly step in which the dilator is collectively inserted into the hub and the sheath tube in a temporary assembly state in a state where the valve body is not yet mounted on the hub;
A sterilization step of sterilizing the hub, the sheath tube and the dilator in the temporarily assembled state;
A valve body mounting step in which the dilator is positioned in the insertion hole through the side slit, the dilator is inserted through the insertion hole, and the valve body is mounted on the hub. A method of manufacturing an introducer assembly.

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