JP2023110184A - Connection member, medical assembly, and sheath introducer - Google Patents

Abstract

To provide a connection member capable of inserting a dilator suitably from a slit of a valving element.SOLUTION: A connection member 300 has a body part 310 extending in the axial direction, a stationary part 320 provided on one end side of the body part, and fixable with a dilator 200, an attachable/detachable part 330 attachable to/detachable from a sheath introducer 100, provided on the other end side of the body part, and a correction part 340 for correcting the insertion direction to the sheath introducer of the dilator so as to follow the axial direction.SELECTED DRAWING: Figure 3

Description

The present invention relates to connecting members, medical assemblies, and introducers.

2. Description of the Related Art Conventionally, in a catheter procedure or the like, an elongated body for medical use is inserted into a biological lumen such as a blood vessel to inspect and treat a lesion. 2. Description of the Related Art A sheath introducer that forms an access route connecting the outside of the body and a biological lumen is known as one of medical elongated bodies.

The sheath introducer includes a sheath tube (catheter body) and a hub connected to the sheath tube. In a procedure using a sheath introducer, the operator inserts a dilator into the sheath tube and percutaneously passes through a puncture site (perforation) formed in the patient's limb, etc., into a biological lumen (for example, Insert the sheath tube into the blood vessel). An operator or the like removes the dilator from the sheath tube while inserting the distal end side of the sheath tube into the blood vessel. After removing the dilator from the sheath tube, an operator or the like can introduce a guide wire, various catheter devices, or the like into the blood vessel through the lumen of the sheath tube.

When inserting the dilator into the sheath tube, the operator or the like inserts the dilator through the slit of the hemostatic valve (valve element) at the upper end of the sheath tube (see, for example, Patent Document 1 below).

JP-A-2008-11867

As described above, when the operator inserts the dilator through the slit at the upper end of the sheath tube, if the dilator is inserted at a position outside the slit, the insertion hole blood may flow backwards from the

SUMMARY OF THE INVENTION It is an object of the present invention to provide a connecting member and a medical assembly that allow a dilator to be suitably inserted through a slit in a valve body.

A connection member according to the present invention that achieves the above object is a connection member to which a dilator and a sheath introducer are connected. A connection member includes a body portion extending in the axial direction, a fixing portion provided on one end side of the body portion and capable of being fixed to the dilator, and a connection member provided on the other end side of the body portion, and the sheath introducer. and a correcting part for correcting the inserting direction of the dilator with respect to the sheath introducer along the axial direction.

In addition, a medical assembly according to the present invention for achieving the above object includes a sheath introducer comprising a sheath hub, a sheath extending toward the distal side of the sheath hub, a dilator hub, and a dilator hub extending toward the distal side of the dilator hub. , a dilator main body having a tapered portion at its distal end, and a main body portion extending in the axial direction, provided with a correction portion for correcting the insertion direction of the dilator with respect to the sheath introducer in the axial direction. , wherein one end side of the main body portion is fixed to the dilator hub, and the other end side of the main body portion is fixed to the sheath hub, the tapered portion of the dilator protrudes from the tip of the sheath. do.

According to the connecting member and the medical assembly configured as described above, when the dilator is inserted into the introducer, the correcting portion causes the insertion direction of the dilator to be aligned with the introducer along the axial direction. be corrected. Therefore, the dilator can be preferably inserted through the slit of the valve body.

1 shows a medical assembly according to a first embodiment of the invention; FIG. 1 is a cross-sectional view of a sheath introducer according to a first embodiment; FIG. 4 is a cross-sectional view of a connection member according to the first embodiment; FIG. FIG. 4 is a diagram showing a state before inserting a dilator into an introducer to which a connecting member according to the first embodiment is fixed; FIG. 4 is a diagram showing a state in which a dilator is inserted through an introducer to which a connecting member according to the first embodiment is fixed, and the dilator and the introducer sheath are connected by the connecting member. FIG. 4 is a diagram showing a state in which the dilator is removed from the introducer while the connection member according to the first embodiment is fixed to the dilator. FIG. 10 is a cross-sectional view of the connecting member according to the second embodiment, showing how the moving member is positioned radially inward. FIG. 8 is a cross-sectional view taken along line 8-8 of FIG. 7; FIG. 11 is a diagram showing a state in which a moving member moves radially outward by inserting a dilator through a connecting member according to the second embodiment; FIG. 10 is a cross-sectional view taken along line 10-10 of FIG. 9; FIG. 10 is a diagram showing a state before a dilator is inserted through an introducer to which a connecting member according to a second embodiment is fixed; FIG. 10 is a diagram showing a state in which the dilator is inserted through the introducer to which the connection member is fixed, and the dilator and the sheath introducer are connected by the connection member according to the second embodiment. FIG. 10 is a diagram showing a state in which the dilator is removed from the introducer while the connection member according to the second embodiment is fixed to the dilator.

An embodiment of the present invention will be described below with reference to FIGS. 1 to 3. FIG. In the description of the drawings, the same elements are denoted by the same reference numerals, and overlapping descriptions are omitted. The dimensional ratios in the drawings are exaggerated for convenience of explanation and may differ from the actual ratios.

FIG. 1 shows a medical assembly 10 according to a first embodiment of the invention. FIG. 2 is a cross-sectional view of the introducer sheath 100 according to the first embodiment. FIG. 3 is a cross-sectional view of the connecting member 300 according to the first embodiment.

In this specification, the side on which the sheath hub 140 of the sheath introducer 100 is arranged (the upper side in FIG. 1) is referred to as the proximal side. The side of the introducer sheath 100 opposite to the proximal side and introduced into the living body (lower side in FIG. 1) is referred to as the distal side. The direction in which the tubular member 130 of the introducer sheath 100 extends (vertical direction in FIG. 1) is called the axial direction.

The medical assembly 10 has a sheath introducer 100, a dilator 200, and a connection member 300 that connects the sheath introducer 100 and the dilator 200, as shown in FIG.

The introducer sheath 100 can be used to introduce a medical elongate body such as a catheter device, a guide wire, or the dilator body 210 of the dilator 200 into a blood vessel through the lumen 131 of the tubular member 130. can.

(Sheath introducer 100)
As shown in FIGS. 1 and 2, the sheath introducer 100 includes a valve body 110, a tubular member (corresponding to a sheath) 130 having a lumen 131 through which the dilator main body 210 can be inserted, and an inner wall of the tubular member 130. It has an internal space 141 that communicates with the cavity 131 and in which the valve body 110 is arranged, a sheath hub 140 fixed to the proximal end side of the tubular member 130, and a through hole 151 through which the dilator main body 210 can be inserted. , and a cap member 150 that contacts the valve body 110 to fix the valve body 110 in the inner space 141 of the sheath hub 140 .

The valve body 110 is arranged in the internal space 141 of the sheath hub 140 of the sheath introducer 100 by the cap member 150 fixed to the sheath hub 140, as shown in FIG.

The valve element 110 has a function of preventing air from flowing into the lumen 131 of the tubular member 130 from the outside and a function of preventing blood that has flowed into the lumen 131 of the tubular member 130 from leaking to the outside. have Therefore, if the dilator 200 is inserted at a position outside the slits 111a and 112a of the valve body 110, blood may flow backward from the insertion hole after the dilator 200 is removed, resulting in blood leakage. .

The valve body 110 is formed in a substantially circular film shape (disk shape). The shape of valve body 110 is not particularly limited as long as it can be arranged in internal space 141 of sheath hub 140 .

The valve body 110 has a first surface 111 provided on the proximal side and a second surface 112 provided on the distal side.

A first slit 111 a is formed in the first surface 111 and a second slit 112 a is formed in the second surface 112 . The first slit 111 a and the second slit 112 a intersect inside the valve body 110 . The first slit 111a and the second slit 112a cross each other in a cross shape when the valve body 110 is viewed from above. The angle at which the first slit 111a and the second slit 112a intersect is not particularly limited.

Although the material constituting the valve body 110 is not particularly limited, for example, silicone rubber, latex rubber, butyl rubber, isoprene rubber, etc., which are elastic members, can be used.

The length in the surface direction of the first slit 111a and the second slit 112a is not particularly limited, but is 3 to 7 mm.

A lumen portion 131 of the tubular member 130 extends substantially linearly from the proximal side to the distal side of the tubular member 130 . A proximal end opening communicating with the internal space 141 of the sheath hub 140 is formed at the proximal end of the tubular member 130 . A distal end opening is formed at the distal end of the tubular member 130 to allow the dilator body 210 to be led out to the distal end side of the tubular member 130 . The distal end of tubular member 130 is configured such that the outer diameter gradually decreases toward the distal end. In other words, the thickness of the distal end of tubular member 130 is configured to gradually decrease toward the distal end.

The sheath hub 140 is connected with a strain relief 160 surrounding a predetermined range on the proximal side of the tubular member 130 . Further, the sheath hub 140 is provided with a side port 142 that communicates with the internal space 141 of the sheath hub 140 . Side port 142 may be connected to one end of tube 180 (see FIG. 1). For example, a three-way stopcock 170 can be connected to the other end of the tube 180 .

The cap member 150 has a convex portion 152 that presses the valve body 110 toward the tubular member 130, and a first engaging portion 153 to which a detachable portion 330 of the connecting member 300, which will be described later, is detachable.

The cap member 150 is arranged at the proximal end of the sheath hub 140 . Cap member 150 is fixed to the proximal end of sheath hub 140 . A method of fixing the cap member 150 to the sheath hub 140 is not particularly limited, but is, for example, bonding with an adhesive. Moreover, the fixing of the cap member 150 to the sheath hub 140 is not limited to fixing with an adhesive, and may be, for example, screwing or fitting.

The sheath hub 140 is formed with a stepped portion 143 that supports the outer periphery of the valve body 110 and holds the valve body 110 within the internal space 141 .

The convex portion 152 sandwiches the outer peripheral portion of the valve body 110 with the stepped portion 143 . The cross-sectional shape and the like of the convex portion 152 are not particularly limited as long as it can press the valve body 110 fixed to the inner space 141 of the sheath hub 140 toward the tubular member 130 side.

The first engaging portion 153 is formed in an L shape so as to be recessed radially outward at a position on the distal end side from the proximal end of the cap member 150 by a predetermined distance.

Materials constituting the tubular member 130 include, for example, polyolefins (eg, polyethylene, polypropylene, polybutene, ethylene-propylene copolymers, ethylene-vinyl acetate copolymers, ionomers, or mixtures of two or more thereof), polyolefin elastomers. , polyolefin crosslinked products, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin (e.g., polytetrafluoroethylene, tetrafluoroethylene-ethylene copolymer, etc.), polycarbonate, polystyrene, A polymeric material such as polyacetal, polyimide, polyetherimide, polyetheretherketone, or a mixture thereof can be used.

Examples of materials that can be used for the sheath hub 140 and the cap member 150 include polyolefins such as polyethylene and polypropylene, polyamides, polycarbonates, and polystyrenes.

(Dilator 200)
The dilator 200, as shown in FIG. a dilator hub 220 fixed proximally.

The dilator 200 can be used to prevent the tubular member 130 from breaking when the tubular member 130 of the sheath introducer 100 is inserted into a blood vessel, or to widen a perforation in the skin.

The dilator main body 210 is inserted into the lumen 131 of the tubular member 130 , and when the sheath introducer 100 and the dilator 200 are connected by the connecting member 300 , the distal end of the dilator main body 210 is aligned with the distal opening of the tubular member 130 . It will be in a state of protruding from the part by a predetermined length.

The dilator main body 210 has a tapered portion 210A at its tip that tapers toward the tip side. A portion of the dilator main body 210 located closer to the proximal side than the tapered portion 210A extends in the axial direction with a substantially constant outer diameter. The axial length of the tapered portion 210A of the dilator main body 210 is not particularly limited, but is, for example, 10 to 25 mm. In a state in which the introducer sheath 100 and the dilator 200 are connected by the connecting member 300, the distal end of the dilator main body 210 is connected to the distal end of the tubular portion 130 of the introducer sheath 100 almost without a step.

The constituent material of the dilator body 210 includes, for example, polyolefin (eg, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyolefin. Elastomers, crosslinked polyolefins, polyvinyl chloride, polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, fluororesins (e.g., polytetrafluoroethylene, tetrafluoroethylene-ethylene copolymers, etc.), polycarbonates, polystyrene , polyacetal, polyimide, polyetherimide, or mixtures thereof.

As shown in FIG. 1, the dilator hub 220 is formed with a convex portion 230 that can be fixed to a fixing portion 320 of the connecting member 300, which will be described later.

As a constituent material of the dilator hub 220, for example, polyolefin such as polyethylene or polypropylene, polyamide, polycarbonate, polystyrene, or the like can be used.

(Connecting member 300)
Next, the configuration of the connection member 300 according to the first embodiment will be described with reference to FIGS. 1 to 3. FIG. The connecting member 300 can connect the dilator 200 and the introducer sheath 100 (see FIG. 5).

As shown in FIG. 3, the connection member 300 includes a main body portion 310 extending in the axial direction, a fixing portion 320 that can be fixed to the dilator 200, a detachable portion 330 that can be attached to and detached from the sheath introducer 100, and a dilator. and a correcting portion 340 for correcting the inserting direction with respect to the introducer sheath 100 of 200 along the axial direction.

The body portion 310 has a lumen 310L through which the dilator 200 can pass. The diameter of the lumen 310L is preferably larger than the outer diameter of the dilator main body 210 and smaller than the length of the first slit 111a of the valve body 110 in the surface direction.

As shown in FIG. 3, the fixing portion 320 is formed on the proximal end side (upper side in FIG. 3) of the connecting member 300. As shown in FIG. The fixed part 320 can fix the convex part 230 formed on the dilator hub 220 of the dilator 200 .

The fixing portion 320 is a threaded groove, as shown in FIG. In addition, the structure of the fixing|fixed part 320 is not limited as long as the dilator 200 can be fixed.

As shown in FIG. 3, the detachable portion 330 is formed on the distal end side (lower side in FIG. 3) of the connecting member 300. As shown in FIG. The detachable portion 330 is a second engaging portion that can engage with the first engaging portion 153 formed on the cap member 150 of the sheath introducer 100 . The detachable portion 330 is configured in an L shape so as to be engageable with the first engaging portion 153 .

Note that the configuration of the detachable portion 330 is not limited as long as it can be detached from the sheath introducer 100 .

In the present embodiment, the fixing force of the fixing portion 320 to the dilator 200 is preferably greater than the fixing force of the detachable portion 330 to the sheath introducer 100 . According to this configuration, as will be described later, when the dilator 200 is pulled out from the sheath introducer 100, only the dilator 200 is pulled toward the proximal end side, so that the dilator 200 can be removed while the connection member 300 is fixed. can be withdrawn from the introducer sheath 100.

The correction part 340 is formed in the body part 310 as shown in FIG. The correction portion 340 is a straight portion longer than the length of the tapered portion 210A formed at the tip of the dilator 200 . The axial length L of the correction portion 340 is not particularly limited as long as it is longer than the axial length of the tapered portion 210A of the dilator 200, and is, for example, 10 to 30 mm.

The material constituting the connecting member 300 is not particularly limited, but polyolefin (eg, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof, etc.) ), polyolefin elastomer, crosslinked polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin (e.g., polytetrafluoroethylene, tetrafluoroethylene-ethylene copolymer, etc.), Polymeric materials such as polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide, mixtures thereof, and the like can be used.

Next, a method of using the medical assembly 10 according to the first embodiment will be described with reference to FIGS. 4 to 6. FIG. 4 to 6 are diagrams for explaining how to use the medical assembly 10 according to the first embodiment.

First, the operator fixes the connecting member 300 to the introducer sheath 100 as shown in FIG. Specifically, connecting member 300 is fixed to sheath introducer 100 by engaging detachable portion 330 of connecting member 300 with first engaging portion 153 of sheath hub 140 of sheath introducer 100 .

Next, the operator inserts the dilator 200 into the sheath introducer 100 to which the connection member 300 is fixed.

Here, for example, when the dilator 200 is inserted into the sheath introducer 100 without the connection member 300 provided, and when the dilator 200 is inserted in a state inclined from the axial direction, the dilator 200 may be inserted into the valve body 110. After the dilator 200 is removed from the sheath introducer 100 by inserting it at a position outside the slits 111a and 112a, blood may flow backward from the insertion hole and cause blood leakage.

In contrast, in the medical assembly 10 according to the present embodiment, the connection member 300 having the correcting portion 340 for correcting the insertion direction of the dilator 200 into the sheath introducer 100 along the axial direction is the sheath introducer. Since the dilator 200 is inserted through the sheath introducer 100 while being fixed to the valve body 100 , the dilator 200 can be preferably inserted through the slits 111 a and 112 a of the valve body 110 .

Next, as shown in FIG. 5 , the dilator 200 is moved to the distal end with respect to the sheath introducer 100 , and the convex portion 230 of the dilator 200 is fixed to the fixing portion 320 of the connection member 300 . As a result, the sheath introducer 100 and the dilator 200 are connected by the connecting member 300 . At this time, the tip of the dilator 200 is exposed by a predetermined length from the tip opening of the tubular member 130 .

Next, the operator inserts the dilator 200 into the introducer sheath 100 (in a state where the introducer sheath 100 and the dilator 200 are connected by the connecting member 300), and inserts the puncture site formed in the limb of the patient. A sheath introducer 100 is percutaneously inserted into a biological lumen (eg, a blood vessel) via a mini-guidewire placed in (perforation).

Next, as shown in FIG. 6, the operator removes the connecting member 300 and the dilator 200 from the introducer sheath 100 while inserting the distal end side of the introducer sheath 100 into the blood vessel. Here, since the fixing force of the fixing part 320 to the dilator 200 is greater than the fixing force of the detachable part 330 to the sheath introducer 100, only the dilator 200 can be removed from the sheath introducer 100 to the proximal side. , the connection member 300 and the dilator 200 can be removed.

Next, the operator removes the dilator 200 from the introducer sheath 100 and then introduces a guide wire, various catheter devices, etc. into the blood vessel through the lumen of the introducer sheath 100 .

As described above, the connection member 300 according to this embodiment is the connection member 300 to which the dilator 200 and the sheath introducer 100 are connected. The connecting member 300 includes a main body portion 310 extending in the axial direction, a fixing portion 320 provided on one end side of the main body portion 310 and capable of being fixed to the dilator 200, and a fixing portion 320 provided on the other end side of the main body portion 310, and a sheath. It has a detachable part 330 that can be attached to and detached from the introducer 100, and a correction part 340 that corrects the insertion direction of the dilator 200 with respect to the sheath introducer 100 along the axial direction. According to the connection member 300 configured in this way, when the dilator 200 is inserted through the sheath introducer 100, the insertion direction of the dilator 200 with respect to the sheath introducer 100 is axially shifted by the correcting portion 340. corrected to fit. Therefore, the dilator 200 can be preferably inserted through the slits 111 a and 112 a of the valve body 110 .

Moreover, the fixing part 320 is a threaded groove. According to the connecting member 300 configured in this manner, the fixing portion 320 can be formed with a simple configuration.

Also, the detachable portion 330 is a second engaging portion that can be engaged with the first engaging portion 153 formed on the introducer sheath 100 . According to the connection member 300 configured in this manner, the connection member 300 can be attached to and detached from the sheath introducer 100 with a simple configuration.

Further, the correction portion 340 is formed in the body portion 310 and is a linear portion longer than the length of the tapered portion 210A formed at the tip of the dilator 200 . According to the connection member 300 configured in this manner, the insertion direction of the dilator 200 into the sheath introducer 100 can be corrected along the axial direction with a simple configuration.

Further, as described above, the medical assembly 10 according to this embodiment includes the sheath introducer 100 including the sheath hub 140 and the tubular member 130 extending toward the distal end of the sheath hub 140, the dilator hub 220, and the dilator hub 220. The dilator 200 includes a dilator main body 210 extending to the distal end side of the dilator hub 220 and having a tapered portion 210A at the distal end, and a correction portion 340 for axially correcting the insertion direction of the dilator 200 into the sheath introducer 100. and a main body portion 310 extending in the axial direction. 200 tapered portion 210A protrudes from the distal end of tubular member 130 . Specifically, the tapered portion 210A of the dilator 200 and the tapered portion provided at the distal end portion of the introducer sheath 100 are arranged in a positional relationship that is continuous without a step. According to the medical assembly 10 configured in this manner, when the dilator 200 is inserted through the introducer sheath 100, the insertion direction of the dilator 200 with respect to the introducer sheath 100 is adjusted by the correcting section 340. Corrected along the direction. Therefore, the dilator 200 can be preferably inserted through the slits 111 a and 112 a of the valve body 110 .

<Second embodiment>
Next, the configuration of the medical assembly 20 according to the second embodiment of the present invention will be described with reference to FIGS. 7 to 10. FIG.

FIG. 7 is a cross-sectional view of the connecting member 400 according to the second embodiment, showing a state in which the moving member 441 is biased by the biasing member 442 and positioned radially inward. 8 is a cross-sectional view taken along line 8-8 of FIG. 7. FIG. FIG. 9 is a diagram showing a state in which the moving member 441 moves radially outward by inserting the dilator 200 through the connecting member 400 according to the second embodiment. 10 is a cross-sectional view taken along line 10-10 of FIG. 9. FIG.

The description of the parts common to the first embodiment will be omitted, and only the features of the second embodiment will be described. The same members as those in the above-described first embodiment are denoted by the same reference numerals, and redundant descriptions are omitted. 2nd Embodiment differs in the structure of the connection member 400 compared with 1st Embodiment.

A medical assembly 20 according to the second embodiment has a sheath introducer 100 , a dilator 200 , and a connection member 400 that connects the sheath introducer 100 and the dilator 200 . Since the configurations of the sheath introducer 100 and the dilator 200 are the same as those of the medical assembly 10 according to the first embodiment described above, description thereof will be omitted.

As shown in FIGS. 7 to 10, the connection member 400 includes a body portion 410 extending in the axial direction, a fixing portion 420 that can be fixed to the dilator 200, and a detachable portion 430 that can be attached to and detached from the introducer sheath 100. , and a correcting portion 440 for correcting the insertion direction of the dilator 200 with respect to the sheath introducer 100 along the axial direction.

The body portion 410 has a lumen 410L through which the dilator 200 can be inserted. The body portion 410 of the connection member 400 according to the second embodiment does not function as the correction portion 340 like the body portion 310 of the connection member 300 according to the first embodiment. It is configured to be shorter than the tapered portion 210A.

The fixing part 420 is configured by a threaded groove, like the fixing part 320 of the connection member 300 according to the first embodiment.

The attachment/detachment portion 430 has an L-shape so that it can be engaged with the first engagement portion 153 formed on the cap member 150 of the sheath introducer 100 in the same manner as the attachment/detachment portion 330 of the connection member 300 according to the first embodiment. It is arranged in letters.

As shown in FIGS. 7 to 10, the correction section 440 includes four moving members 441 that can move in the radial direction, and four biasing members 442 that bias the moving members 441 radially inward. , has

As shown in FIGS. 7 and 8, in the normal state, the four moving members 441 are biased radially inward by the four biasing members 442 and are in contact with each other. With the four moving members 441 in contact with each other, as shown in FIG. 8, a hole 441H is formed between the four moving members 441 so that the tip of the dilator 200 can pass therethrough.

The biasing member 442 has one end fixed to the moving member 441 and the other end fixed to the main body portion 410 . The biasing member 442 is a spring.

9, when the dilator 200 is inserted into the connection member 400 in the correcting section 440 configured as described above, the moving member 441 first comes into contact with the tapered portion 210A at the tip of the dilator 200, As the tapered portion 210A of 200 passes through, the four moving members 441 move radially outward against the biasing force of the biasing member 442 as shown in FIGS. In this way, when the dilator 200 is inserted, the dilator 200 moves toward the distal side while being in contact with the four moving members 441 due to the biasing force of the biasing member 442 . The insertion direction with respect to 100 can be corrected along the axial direction.

Next, a method of using the medical assembly 20 according to the second embodiment will be described with reference to FIGS. 11 to 13. FIG. 11 to 13 are diagrams for explaining how to use the medical assembly 20 according to the second embodiment.

First, the operator fixes the connecting member 400 to the introducer sheath 100 as shown in FIG. Specifically, connecting member 400 is fixed to sheath introducer 100 by engaging detachable portion 430 of connecting member 400 with first engaging portion 153 of sheath hub 140 of sheath introducer 100 .

Next, the operator inserts the dilator 200 into the sheath introducer 100 to which the connection member 400 is fixed. At this time, the dilator 200 moves toward the distal side while contacting the four moving members 441 due to the biasing force of the biasing member 442. Therefore, the insertion direction of the dilator 200 into the sheath introducer 100 is along the axial direction. can be corrected as follows. Therefore, the dilator 200 can be preferably inserted through the slits 111 a and 112 a of the valve body 110 .

Next, as shown in FIG. 12 , the dilator 200 is moved to the distal end with respect to the sheath introducer 100 to fix the convex portion 230 of the dilator 200 to the fixing portion 420 of the connecting member 400 . As a result, the sheath introducer 100 and the dilator 200 are connected by the connecting member 400 . At this time, the tip of the dilator 200 is exposed by a predetermined length from the tip opening of the tubular member 130 .

Next, the operator inserts the dilator 200 into the introducer sheath 100 (in a state where the introducer sheath 100 and the dilator 200 are connected by the connecting member 400), and inserts the puncture site formed in the limb of the patient. A sheath introducer 100 is percutaneously inserted into a biological lumen (eg, a blood vessel) via a mini-guidewire placed in (perforation).

Next, the operator removes the connecting member 400 and the dilator 200 from the introducer sheath 100 while inserting the distal end side of the introducer sheath 100 into the blood vessel.

Next, the operator removes the dilator 200 from the introducer sheath 100 and then introduces a guide wire, various catheter devices, etc. into the blood vessel through the lumen of the introducer sheath 100 .

As described above, the correcting portion 440 of the connection member 400 according to the second embodiment includes four moving members 441 that are movable along the radial direction, and biases the moving members 441 radially inward. and a biasing member 442 . According to the connection member 400 configured in this manner, the length of the main body portion 410 need not be longer than the length of the tapered portion 210A of the dilator 200, so the connection member 400 can be miniaturized.

The configurations of the connection members 300 and 400 and the medical assemblies 10 and 20 according to the present invention have been described above through the embodiments, but the present invention is not limited to the above-described embodiments, and various modifications can be made within the scope of the claims. is possible.

For example, in the first embodiment described above, the connection member 300 was configured separately from the introducer sheath 100 and fixed during use. However, the connecting member 300 may be fixed to the introducer sheath 100 in advance by welding or the like. According to this configuration, the process of fixing the connection member 300 to the sheath introducer 100 can be omitted, which facilitates the work.

Also, in the above-described second embodiment, four moving members 441 and four biasing members 442 are provided, but the number is not particularly limited as long as the number is two or more.

10, 20 medical assembly;
100 sheath introducer,
110 valve body,
111a first slit (slit),
112a second slit (slit),
140 sheath hub,
153 first engaging portion,
200 dilator,
210 dilator body,
210A tapered portion,
220 dilator hub,
300, 400 connection member,
310, 410 main body,
320, 420 fixed part,
330, 430 detachable part,
340, 440 correction unit,
441 moving member;
442 biasing member;

Claims (7)

A connection member to which the dilator and the sheath introducer are connected,
an axially extending body;
a fixing portion provided on one end side of the main body portion and capable of being fixed to the dilator;
A detachable portion provided on the other end side of the main body portion and detachable from the sheath introducer;
and a correcting portion that corrects an insertion direction of the dilator with respect to the sheath introducer so as to be along the axial direction. The connecting member according to claim 1, wherein the fixing portion is a threaded groove. The connection member according to claim 1 or 2, wherein the detachable portion is a second engaging portion engageable with a first engaging portion formed on the introducer sheath. The connecting member according to any one of claims 1 to 3, wherein the correcting portion is formed in the body portion and is a straight portion longer than the length of the tapered portion formed at the tip of the dilator. The correction unit is
at least two moving members that are radially movable;
The connection member according to any one of claims 1 to 3, further comprising a biasing member that biases the moving member inward in the radial direction. a sheath introducer comprising a sheath hub and a sheath extending toward the distal end of the sheath hub;
a dilator comprising a dilator hub and a dilator main body extending toward the distal end of the dilator hub and having a tapered portion at the distal end;
a body portion extending in the axial direction, comprising a correcting portion for axially correcting an insertion direction of the dilator with respect to the sheath introducer;
A medical assembly in which the tapered portion of the dilator protrudes from the distal end of the sheath when one end of the main body is fixed to the dilator hub and the other end of the main body is fixed to the sheath hub. . a hub;
a sheath extending toward the distal end of the hub;
A main body extending in the axial direction, comprising a correcting portion integrally formed with the base end portion of the hub and configured to axially correct an insertion direction of a dilator insertable into the hub and the sheath with respect to a sheath introducer. and a sheath introducer.