JP2022018318A - Introducer assembly and use method of introducer assembly - Google Patents

Abstract

To provide an introducer assembly capable of suppressing turn-up of an end portion of a sheath by external force in puncture, and use method of the introducer assembly.SOLUTION: An introducer assembly 10 comprises a sheath 110 including, at least a tip end portion 111 thereof, a first protrusion 113 spirally provided along an axial direction and a first recess 114 provided between the adjacent first protrusion, and a dilator 200 including, at least a tip end portion 211 thereof, a second protrusion 213 spirally provided along the axial direction and a second recess 214 provided between the adjacent second protrusion. When the dilator is assembled with the sheath, a continuous spiral body 300 is formed by the first protrusion and the second protrusion. The introducer assembly further comprises a fixing part 400 for fixing the position of the dilator relative to the sheath such that a tip end side 113A of the first protrusion and a base end side 213B of the second protrusion come into contact with each other.SELECTED DRAWING: Figure 1

Description

The present invention relates to an introducer assembly and a method of using the introducer assembly.

Conventionally, a medical instrument called an introducer assembly has been used as an instrument for introducing a catheter or the like into a living lumen (see, for example, Patent Document 1). The introducer assembly is composed of a sheath and a dilator that is configured to be insertable into the lumen of the sheath and is used in combination with the sheath.

International Publication No. 2011/122488

However, when the dilator is attached to the sheath, there is a possibility that a step may occur at the joint between the tip of the sheath and the dilator protruding from the tip of the sheath. Therefore, the end of the sheath is susceptible to external force from the object to be punctured when the operator punctures the patient with the introducer assembly, which may cause the sheath to turn over.

Therefore, an object of the present invention is to provide an introducer assembly and a method of using the introducer assembly, which can prevent the end portion of the sheath from being turned over by an external force at the time of puncture.

The introducer assembly that achieves the above object has at least a tip portion of a first convex portion provided spirally along the axial direction and a first concave portion provided between the adjacent first convex portions. A sheath having a sheath, a second convex portion spirally provided along the axial direction, and a second concave portion provided between the adjacent second convex portions, and a dilator having at least a tip portion thereof. When the dilator is assembled to the sheath, a continuous spiral body is formed by the first convex portion and the second convex portion, and the tip end side of the first convex portion and the base end of the second convex portion are formed. It further has a fixing portion for fixing the position of the dilator with respect to the sheath so as to be in contact with the side.

The method of using the introducer assembly to achieve the above object is to further puncture the introducer assembly into a blood vessel and remove a medical long body inserted into a sheath constituting the introducer assembly. The present invention includes a method of hooking the first convex portion at least partially on the blood vessel wall when the medical elongated body is moved to the proximal end side.

According to the introducer assembly constructed as described above, when the dilator is assembled to the sheath, the spiral convex portion formed on the sheath and the spiral convex portion formed on the dilator are continuous. A spiral is formed. Therefore, the introducer assembly can disperse the external force received from the puncture target at the time of puncture. Therefore, the introducer assembly can prevent the end of the sheath from being turned over by an external force during puncture.

According to the method of using the introducer assembly configured as described above, the introducer assembly can disperse the external force received from the puncture target at the time of puncture. Therefore, the introducer assembly can prevent the end of the sheath from being turned over by an external force during puncture.

It is the introducer assembly which concerns on this embodiment, and is the figure which shows the state before assembling the dilator to the sheath. It is a figure which shows the state which the dilator is attached to the sheath, and is the figure which shows the tip portion of the sheath. It is a figure which shows the usage of the introducer assembly. It is a figure which shows the usage of the introducer assembly.

Hereinafter, the introducer assembly 10 according to the present embodiment will be described with reference to each figure. 1 and 2 are diagrams for explaining each part of the introducer assembly 10.

With reference to FIG. 2, in the present specification, the side (upper side in FIG. 1) where the hub 120 is arranged in the sheath 100 of the introducer assembly 10 is referred to as a “base end side”. Further, the side of the sheath 100 located on the side opposite to the base end side and introduced into the living body (lower side in FIG. 1) is referred to as "tip side". Further, the direction in which the sheath 100 extends (vertical direction in FIG. 1) is referred to as "axial direction". Further, in the description of the specification, the "tip portion" means a certain range including the tip (tip) and its periphery, and the "base end portion" means the proximal end (most proximal end) and its periphery. It shall mean a certain range including.

As shown in FIG. 1, the introducer assembly 10 according to the present embodiment has a sheath 100 and a dilator 200 that can be inserted into the lumen 115 of the sheath 100.

(Sheath 100)
The sheath 100 is placed in a living lumen such as a blood vessel, and an instrument such as a catheter or a guide wire is inserted into the sheath 100 and used to introduce them into the living lumen.

As shown in FIG. 1, the sheath 100 includes a catheter body (sheath tube) 110 that is percutaneously introduced into the living lumen, a hub (sheath hub) 120 connected to the proximal end side of the catheter body 110, and a hub. It has a hemostatic valve (not shown) disposed in the lumen of 120.

The catheter body 110 is formed of a tubular member having a substantially cylindrical shape. As shown in FIGS. 1 and 2, the catheter body 110 has a tapered tip portion 111 and a proximal end portion 112 connected to the hub 120. A tip opening 111a is formed at the tip of the tip 111.

Further, the catheter body 110 includes a lumen 115 extending in the axial direction. The distal end portion 111 of the catheter body 110 has a tapered portion that tapers as the outer diameter toward the distal end side. The inner diameter of the tip 111 of the catheter body 110 is not particularly limited, and for example, as shown in FIG. 1, the inner diameter may be constant.

Further, as shown in FIGS. 1 and 2, the tip portion 111 of the catheter main body 110 is provided between the first convex portion 113 provided spirally along the axial direction and the adjacent first convex portion 113. It has a first recess 114 and the like. As shown in FIG. 2, the tip end side 113A of the first convex portion 113 comes into contact with the proximal end side 213B of the second convex portion 213 formed on the dilator 200 when the dilator 200 is assembled to the sheath 100. The second convex portion 213 of the dilator 200 will be described later.

As shown in FIG. 1, the hub 120 has a hub body 121 to which a proximal end portion of the catheter body 110 is fixed. The hub body 121 is provided with a lumen (not shown) communicating with the lumen 115 of the catheter body 110, and a side port 122 communicating with the lumen.

One end of the flexible tube 151 (see FIG. 1) is liquidtightly connected to the side port 122. For example, a three-way stopcock 150 is attached to the other end of the tube 151. A liquid such as saline can be injected from the port of the three-way stopcock 150 into the lumen 115 of the catheter body 110 via the tube 151.

(Dilator 200)
As shown in FIG. 1, the dilator 200 has a dilator main body 210 configured to be inserted into the catheter main body 110 and a dilator hub 220 configured to be connectable to the hub 120.

The dilator 200 is used to prevent the catheter body 110 from breaking or to widen the perforation of the skin when the catheter body 110 of the sheath 100 is inserted into the living lumen. Further, the dilator 200 is used to insert an instrument such as a guide wire into the dilator 200 and introduce them into the living lumen.

The dilator main body 210 is formed of a substantially cylindrical tubular member, and a tip opening 211a is formed at the tip of the tip portion 211 of the dilator main body 210. Further, when the dilator main body 210 is inserted through the catheter main body 110, the tip portion 211 thereof is in a state of protruding from the tip opening portion 111a of the catheter main body 110.

Further, the tip portion 211 of the dilator main body 210 has a tapered portion 211T that tapers as the outer diameter toward the tip side. The tapered portion 211T is a portion that first comes into contact with the skin when the introducer assembly 10 is punctured into the skin. Therefore, the operator can easily introduce the introducer assembly 10 into the skin by having the dilator main body 210 having the tapered portion 211T. Therefore, even when the introducer assembly 10 is punctured into the skin, the operator can more easily perform the operation of introducing the introducer assembly 10 into the skin. The inner diameter of the tip portion 211 of the dilator main body 210 is not particularly limited and may be constant.

Further, as shown in FIG. 1, the tip portion 211 of the dilator main body 210 is provided between the second convex portion 213 spirally provided along the axial direction and the adjacent second convex portion 213. It has two recesses 214 and. As shown in FIG. 2, the proximal end side 213B of the second convex portion 213 comes into contact with the distal end side 113A of the first convex portion 113 formed on the sheath 100 when the dilator 200 is assembled to the sheath 100. Therefore, as shown in FIG. 2, the introducer assembly 10 has a continuous spiral body 300 formed by the first convex portion 113 of the sheath 100 and the second convex portion 213 of the dilator 200.

The pitch, size (height), and number of turns of the spiral body 300 are not particularly limited.

Further, the length (length in the axial direction) of the spiral body 300 is not particularly limited.

The first convex portion 113 and the second convex portion 213 forming the spiral body 300 are fixed so as to be in contact with each other by the fixing portion 400. The fixing portion 400 is composed of, for example, a caulking pin provided on the sheath 100 and the dilator 200, respectively. Therefore, a concave portion 401 (or a convex portion) is formed in the sheath 100, and a convex portion 402 (or a concave portion) of the dilator 200 is formed. The first convex portion 113 and the second convex portion 213 are fixed by fitting the convex portion 402 (or concave portion) of the dilator 200 to the concave portion 401 (or convex portion) of the sheath 100. The method of fixing the dilator 200 to the sheath 100 is not particularly limited, and fitting by screwing may be used.

Further, the sheath 100 and the dilator 200 may be provided with markers m1 and m2 (see FIG. 1) for confirming the position of the dilator 200 with respect to the sheath 100. When the operator inserts the dilator main body 210 into the catheter main body 110, the marker m1 provided on the dilator 200 and the marker m2 provided on the sheath 100 are combined so that the operator 113A on the tip end side of the first convex portion 113. It is possible to confirm the position of the base end side 213B of the second convex portion 213 with respect to the relative. The number and shape of the markers provided on the sheath 100 and the dilator 200 are not particularly limited.

(How to use the introducer assembly)
Next, a method of using the introducer assembly 10 described above will be described. 3 and 4 are diagrams for explaining how to use the introducer assembly 10.

When the introducer assembly 10 is punctured into the puncture target (for example, the skin), the surgeon inserts the tip of the spiral body 300 into the skin H while rotating the tip of the spiral body 300 along the axial direction of the introducer assembly 10. As a result, the introducer assembly 10 can form the hole 500 in the skin H and the spiral groove 510 in the inner wall of the hole 500 (see FIG. 3).

The introducer assembly 10 has a surface (first convex portion 113 and second convex portion 213) of the spiral body 300, a surface between adjacent spiral bodies 300 (first concave portion 114 and second concave portion 214), and a hole portion 500. The skin H is punctured with the spiral groove portion 510 in contact with the skin H at least partially (see FIG. 3). Therefore, the introducer assembly 10 can disperse the external force applied to the introducer assembly 10 at the time of puncturing to the surface of the spiral body 300 or the surface between the adjacent spiral bodies 300. Therefore, the introducer assembly 10 can prevent the tip 111 of the sheath 100 from being turned over by an external force at the time of puncturing, and can reduce damage to the skin H at the time of puncturing.

In addition, the surgeon can advance the introducer assembly 10 (introduce it into the skin H) using the spiral body 300 as a guide. Also, the surgeon can hook the spiral body 300 to the groove 510 of the skin H at least partially. Therefore, the introducer assembly 10 can be prevented from coming off the skin H at the time of puncturing.

The target of puncture is not limited to the skin H. For example, the puncture target may be a blood vessel. The surgeon can advance the inside of the blood vessel by turning the introducer assembly 10 along the axial direction. As a result, the introducer assembly 10 can prevent the tip 111 of the sheath 100 from being turned over by an external force at the time of puncturing, and can reduce damage to the blood vessel wall L at the time of puncturing.

Further, when the introducer assembly 10 is further punctured into the blood vessel, the surgeon removes the dilator 200 inserted through the sheath 100 and inserts a medical long body G (for example, a guiding catheter) into the sheath 100. It can be inserted. Further, the surgeon can remove the medical long body G inserted through the sheath 100 in a state where the sheath 100 is punctured into a blood vessel. The surgeon can hook the first convex portion 113 of the sheath 100 to the blood vessel wall L at least partially when moving the medical elongated body G toward the proximal end side (see FIG. 4). Therefore, the introducer assembly 10 can prevent the sheath 100 from coming out of the blood vessel when the operator pulls back the medical long body G inserted into the sheath 100.

(Constituent materials of introducer assembly)
Next, the constituent materials of the introducer assembly 10 described above will be described.

The material constituting the catheter body 110 is not particularly limited, and is, for example, a polyolefin (for example, polyethylene, polypropylene, polybutene, an ethylene-propylene copolymer, an ethylene-vinyl acetate copolymer, an ionomer, or a mixture of two or more thereof). , Polyolefin elastomer, crossed body of polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin, polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide, ethylene / tetrafluoroethylene Polymer materials such as copolymer (ETFE), tetrafluoroethylene / hexafluoropropylene copolymer (FEP), polyetheretherketone (PEEK), polyvinyl chloride (PVDF), or mixtures thereof can be used. ..

Further, it is possible to form a coating layer having lubricity on the outer surface and / or the inner surface of the catheter body 110. As a material for forming the coating layer, a known coating material having hydrophilicity or hydrophobicity can be used.

The material constituting the hub 120 is not particularly limited, and polyolefins such as polyethylene and polypropylene, polyamide, polycarbonate, polystyrene and the like can be used.

The material constituting the dilator main body 210 is not particularly limited, and the material is not particularly limited, and is limited to polyolefins such as polypropylene (PP) and polyethylene (PE), nylon, polyesters such as polyethylene terephthalate (PET), polyvinylidene fluoride (PVDF), and tetrafluoroethylene. -A fluoropolymer such as a hexafluoropropylene copolymer (FEP) can be used.

Further, the constituent material of the dilator hub 220 is not particularly limited, and polyolefins such as polyethylene and polypropylene, polyamide, polycarbonate, polystyrene and the like can be used.

As described above, the introducer assembly 10 according to the present embodiment is provided between the first convex portion 113 spirally provided along the axial direction and the adjacent first convex portion 113. A second concave portion 214 provided between a sheath 100 having a concave portion 114 at least at the tip portion 111, a second convex portion 213 spirally provided along the axial direction, and an adjacent second convex portion 213. When the dilator 200 is assembled to the sheath 100, the continuous spiral body 300 is formed by the first convex portion 113 and the second convex portion 213, and the first Further, there is a fixing portion 400 for fixing the position of the dilator 200 with respect to the sheath 100 so that the tip end side 113A of the convex portion 113 and the proximal end side 213B of the second convex portion 213 are in contact with each other.

According to the introducer assembly 10 configured in this way, the surgeon introduces the tip of the spiral body 300 with respect to the skin H when the introducer assembly 10 is punctured into the puncture target (for example, the skin). Insert while rotating along the axial direction of the assembly 10. Thereby, the introducer assembly 10 can form the hole portion 500 in the skin H and the spiral groove portion 510 in the inner wall of the hole portion 500. Further, the introducer assembly 10 has holes and a surface (first concave portion 114 and second concave portion 214) between the surface of the spiral body 300 (first convex portion 113 and the second convex portion 213) and the adjacent spiral bodies 300. The skin H is punctured with the spiral groove portion 510 of the portion 500 in contact with the skin H at least partially. Therefore, the introducer assembly 10 can disperse the external force applied to the introducer assembly 10 at the time of puncturing to the surface of the spiral body 300 or the surface between the adjacent spiral bodies 300. Therefore, the introducer assembly 10 can prevent the tip 111 of the sheath 100 from being turned over by an external force at the time of puncturing, and can reduce damage to the skin H at the time of puncturing.

Further, the tip portion 211 of the dilator 200 has a tapered portion 211T that tapers toward the tip side. Therefore, the surgeon can easily introduce the introducer assembly 10 into the skin. Therefore, even when the introducer assembly 10 is punctured into the skin, the operator can more easily perform the operation of introducing the introducer assembly 10 into the skin.

Further, the method of using the introducer assembly 10 according to the present embodiment is a method of puncturing the blood vessel with the introducer assembly 10, and moving the introducer assembly 10 forward in the blood vessel by turning the introducer assembly 10 along the axial direction. Including how to make it. As a result, the introducer assembly 10 can prevent the tip 111 of the sheath 100 from being turned over by an external force at the time of puncturing, and can reduce damage to the blood vessel wall L at the time of puncturing.

Further, the method of using the introducer assembly 10 is to further puncture the introducer assembly 10 into the blood vessel and remove the medical long body G inserted into the sheath 100 constituting the introducer assembly 10. The present invention includes a method of hooking the first convex portion 113 to the blood vessel wall L at least partially when the medical elongated body G is moved to the proximal end side. Therefore, the introducer assembly 10 can prevent the sheath 100 from coming out of the blood vessel when the operator pulls back the medical long body G inserted into the sheath 100.

Although the introducer assembly 10 according to the present invention has been described above through the embodiments, the present invention is not limited to each configuration described in the specification, and is appropriately modified based on the description of the scope of claims. It is possible to do.

For example, the specific structure of the sheath 100 and the specific structure of the dilator 200 are not limited to those described in the illustration, and can be appropriately changed as long as they can function as an introducer. ..

10 Introducer assembly,
100 sheath,
110 Catheter body,
111 Sheath tip,
113 First convex part,
114 1st recess,
120 hubs,
200 dilator,
210 Dilator body,
211 Dilator tip,
211T taper part,
213 Second convex part,
214 Second recess,
220 Dilator Hub,
300 spiral,
400 fixed part,
H skin,
L vessel wall.

Claims (4)

A sheath having at least a first convex portion spirally provided along the axial direction and a first concave portion provided between the adjacent first convex portions at the tip portion.
It has a second convex portion spirally provided along the axial direction, a second concave portion provided between the adjacent second convex portions, and a dilator having at least a tip portion thereof.
When the dilator is assembled to the sheath, a continuous spiral body is formed by the first convex portion and the second convex portion, and the tip end side of the first convex portion and the base end side of the second convex portion are formed. An introducer assembly further comprising a fixing portion for fixing the position of the dilator with respect to the sheath so as to be in contact with the sheath. The introducer assembly according to claim 1, wherein the tip portion of the dilator has a tapered portion that tapers toward the tip side. A method of puncturing a blood vessel with the introducer assembly according to claim 1 or 2.
A method of using an introducer assembly, comprising a method of advancing the inside of the blood vessel by turning the introducer assembly along an axial direction. A method of further puncturing the introducer assembly into a blood vessel and removing a medical long body inserted into a sheath constituting the introducer assembly.
The method of using the introducer assembly according to claim 3, which comprises a method of hooking the first convex portion to the blood vessel wall at least partially when moving the medical elongated body toward the proximal end side.

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