JP2016163667A - Introducer sheath set - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an introducer sheath set capable of performing, for example, a procedure using a catheter easily and smoothly.SOLUTION: An introducer sheath set 10 comprises: a guide member 4 having a long wire body 41 with flexibility, and an expanded diameter part 42 which is provided at a predetermined position in a longitudinal direction of the wire body 41, and whose outer diameter is expanded; and a tubular introducer sheath 1 which has a tip opening 22, and into which the guide member 4 is inserted from a base end side. The introducer sheath set is inserted into a blood vessel from a distal end side in an assembled state where the introducer sheath set is assembled by inserting the guide member 4 into the introducer sheath 1. The expanded diameter part 42 functions as a mitigation part which mitigates a step between an outer peripheral part of the wire body 41 and an outer peripheral part of the introducer sheath 1 in the assembled state.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an introducer sheath set.

  In recent years, various forms of treatment are performed in medicine using an elongated hollow tubular medical device called a catheter.

  As such a treatment method, a method of directly administering a drug to an affected part (lesion) using the longness of a catheter, or a catheter with a balloon that is expanded by pressurization attached to the tip thereof is used. A method of expanding and opening the stenosis, a method of scraping and opening the affected part using a catheter with a cutter attached to the tip, and a method of closing and closing an aneurysm, bleeding site or feeding blood vessel using a catheter There is.

  In addition, there is a treatment method in which a stent having a tubular shape with a meshed side surface is implanted and placed in a blood vessel using a catheter in order to maintain the narrowed portion in the blood vessel in an open state.

  As one means for inserting such a catheter into a blood vessel, there is a blood vessel securing method called the Seldinger method using an introducer sheath (see, for example, Patent Document 1).

  The introducer sheath is inserted into the living body along the guide wire so as to pass through the guide wire inserted in the living body in advance. Then, the guide wire is removed from the introducer sheath, and only the introducer sheath is placed in the blood vessel. The catheter can be inserted into the living body via the introducer sheath to perform the above-described treatment.

  Here, there is a relatively large difference between the outer diameter of the guide wire and the outer diameter of the introducer sheath. For this reason, a step is generated when the introducer sheath is inserted through the guide wire. This step increases the burden on the living body when the introducer sheath is inserted.

  In view of the above, conventionally, when an introducer sheath is inserted into a living body, the introducer sheath is inserted into the living body in a state where the introducer sheath is inserted and a tubular dilator functioning as a stylet is inserted. This dilator has a tubular shape and is inserted into the living body in a state of protruding from the tip of the introducer sheath. At the time of insertion, the step between the guide wire and the introducer sheath is relaxed by the dilator, and the burden on the living body is reduced.

  However, this dilator is used only when the introducer sheath is inserted into the living body, and once the introducer sheath is placed in the living body, it cannot be used again. Therefore, using the dilator only for this purpose only increases the number of medical tools used for the procedure, and the procedure becomes complicated.

JP 2011-212417 A

  The objective of this invention is providing the introducer sheath set which can perform the procedure using a catheter easily and smoothly, for example.

Such an object is achieved by the present inventions (1) to (8) below.
(1) a guide member having a flexible long wire body, a diameter-adjusted portion provided at a predetermined position in the longitudinal direction of the wire body, and having an enlarged outer diameter, and a tip opening An introducer sheath set comprising an introducer sheath having a lumen through which the guide member is inserted,
In the assembled state in which the guide member is inserted into the introducer sheath and assembled, a step difference is eased between the guide member and the outer peripheral surface of the introducer sheath at the enlarged diameter portion protruding from the tip opening. An introducer sheath set comprising a mechanism.

  (2) The introducer sheath according to (1), wherein the step height reducing mechanism in the enlarged diameter portion includes a tapered portion in which an outer diameter of the enlarged diameter portion gradually decreases from a proximal end side toward a distal end side. set.

(3) The introducer sheath has a sheath side taper portion whose outer diameter gradually decreases toward the distal end side at the distal end portion thereof,
The introducer sheath set according to (2), wherein the tapered portion has a smaller taper angle than the sheath-side tapered portion.

  (4) The introducer according to (2) or (3) above, wherein the step reducing mechanism in the enlarged diameter portion has a constant outer diameter portion having a constant outer diameter on the proximal end side with respect to the tapered portion. Sheath set.

(5) The introducer sheath has a valve body that is provided on the inner periphery of the proximal end, is configured by a film-like elastic body, and has an openable opening / closing hole that penetrates in the thickness direction thereof.
The enlarged diameter portion is provided on the proximal end side of the tapered portion, and has a proximal end side tapered portion whose outer diameter gradually decreases from the distal end side toward the proximal end side,
When the guide member is removed from the introducer sheath, the proximal end side tapered portion has a function of preventing the enlarged diameter portion from being caught in the opening / closing hole. The introducer sheath set according to any one of the above.

  (6) In the state where the guide member is projected from the introducer sheath, the step reducing mechanism in the enlarged diameter portion is in order of the tapered portion, the constant outer diameter portion, and the sheath side tapered portion from the distal end side. The introducer sheath set according to (5), which is arranged side by side.

  (7) The guide member includes a positioning portion that is provided at a proximal end portion of the wire main body, and that allows a relative positioning in a longitudinal direction of the enlarged diameter portion with the introducer sheath. 1) The introducer sheath set according to any one of (6).

  (8) Prior to inserting the assembly in which the guide member and the introducer sheath are assembled into the blood vessel, the blood vessel is punctured, and the guide member and the introducer sheath are in the punctured state. The introducer sheath set according to any one of (1) to (7), further including a tubular puncture needle to be inserted.

  According to the present invention, the diameter-enlarged portion provided in the guide member functions as a relaxing portion that relaxes the step between the guide member and the introducer sheath. Thereby, it is possible to omit the separate use of the medical device for relaxing the step. Therefore, the procedure can be easily and smoothly performed.

It is a side view which shows the introducer sheath set (1st Embodiment) of this invention. It is an expanded sectional view of the hub with which the introducer sheath shown in FIG. 1 is provided. It is an expanded sectional view of the enlarged diameter part with which the introducer sheath set shown in FIG. 1 is provided. (A)-(c) is sectional drawing which shows the process in which a guide member is extracted from an introducer sheath. It is a figure for demonstrating the usage method of the introducer sheath set shown in FIG. It is a figure for demonstrating the usage method of the introducer sheath set shown in FIG. It is a figure for demonstrating the usage method of the introducer sheath set shown in FIG. It is a figure for demonstrating the usage method of the introducer sheath set shown in FIG. It is a figure for demonstrating the usage method of the introducer sheath set shown in FIG. It is a figure for demonstrating the usage method of the introducer sheath set shown in FIG. It is an expanded sectional view which shows the assembly state of the introducer sheath set (2nd Embodiment) of this invention.

  Hereinafter, the introducer sheath set of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.

<First Embodiment>
FIG. 1 is a side view showing an introducer sheath set (first embodiment) of the present invention. FIG. 2 is an enlarged cross-sectional view of a hub provided in the introducer sheath shown in FIG. FIG. 3 is an enlarged cross-sectional view of a diameter-expanded portion provided in the introducer sheath set shown in FIG. 4A to 4C are cross-sectional views showing a process of removing the guide member from the introducer sheath. FIG. 5 is a view for explaining a method of using the introducer sheath set shown in FIG. FIG. 6 is a diagram for explaining a method of using the introducer sheath set shown in FIG. FIG. 7 is a view for explaining a method of using the introducer sheath set shown in FIG. FIG. 8 is a view for explaining a method of using the introducer sheath set shown in FIG. FIG. 9 is a view for explaining a method of using the introducer sheath set shown in FIG. FIG. 10 is a view for explaining a method of using the introducer sheath set shown in FIG.

  In the following, for convenience of explanation, the left side of FIGS. 1 to 10 (the same applies to FIG. 11) is referred to as “left” or “front end side”, and the right side is referred to as “right” or “base end side”.

  The introducer sheath set 10 of the present invention is, for example, an instrument for securing a blood vessel prior to performing catheter treatment by inserting a catheter into the blood vessel. The introducer sheath set 10 includes an introducer sheath 1, a guide member 4, and an introduction needle assembly 6. Hereinafter, these will be described in order.

  The introducer sheath 1 is used by being placed in a blood vessel, and a long medical object such as a catheter is inserted into the introducer sheath 1 and introduced into the blood vessel. The introducer sheath 1 includes a sheath tube 2, a hub 3 provided at the proximal end portion of the sheath tube 2, and a side tube 5.

  The sheath tube 2 shown in FIGS. 1 to 3 is introduced into a blood vessel percutaneously. The sheath tube 2 has a lumen 20 through which the elongated object can be inserted. The sheath tube 2 has flexibility, but is hard enough to maintain the lumen portion 20 sufficiently when inserted into the living body.

  As a constituent material of the sheath tube 2, a relatively flexible resin material can be used. Particularly, high density polyethylene, polyolefin such as polypropylene, polyamide such as nylon 66, polyurethane, polyethylene terephthalate, polybutylene terephthalate, Preference is given to those mainly comprising at least one selected from the group consisting of fluororesins such as polyesters such as polycyclohexane terephthalate, polytetrafluoroethylene, and ethylene-tetrafluoroethylene copolymers.

  Since these materials are particularly materials with low frictional resistance (low friction materials), by forming the sheath tube 2 with such materials, operations for inserting into the lumen 20 of the dilator or catheter, The operation of pulling out 20 can be easily and reliably performed.

  Such a constituent material may contain particles composed of a radiopaque material (radiopaque material). Thereby, the visibility of the sheath tube 2 under X-ray fluoroscopy is improved. Examples of such radiopaque materials include bismuth oxide and barium sulfate.

  Further, a film made of silicon resin or the like may be formed on the inner surface of the sheath tube 2. Thereby, the frictional force is further reduced on the inner surface of the sheath tube 2.

  The outer surface and inner surface of the sheath tube 2 are preferably subjected to a hydrophilic treatment. Thereby, when the outer surface of the sheath tube 2 comes into contact with a liquid such as blood or physiological saline, lubricity is exhibited, the frictional resistance of the sheath tube 2 is reduced, and the slidability is further improved. The insertion operation into the meandering blood vessel becomes easier.

  This hydrophilization treatment is performed, for example, by applying (applying) a surfactant, water-soluble silicon, a hydrophilic polymer material in addition to physical activation treatment such as plasma treatment, glow discharge, corona discharge, and ultraviolet irradiation. Can do.

  Further, the hydrophilic polymer material is not particularly limited. For example, a cellulose polymer material (for example, hydroxypropyl cellulose), a polyethylene oxide polymer material (for example, polyethylene glycol), a maleic anhydride polymer material ( For example, one or more of methyl vinyl ether-maleic anhydride copolymer), acrylamide polymer (for example, acrylamide-glycidyl methacrylate copolymer), water-soluble nylon and the like can be used in combination.

Further, the sheath tube 2 has a sheath side taper portion 21 whose outer diameter is reduced in the distal direction at the distal end portion thereof. The taper angle θ ₁ of the sheath-side taper portion 21 is not particularly limited, but is preferably 2 to 60 °, and more preferably 5 to 30 °, for example. The length _{L 3} of sheath-side taper portion 21 is not particularly limited, for example, about 1 to 30 mm.

  Moreover, the inner diameter of the sheath tube 2 is not particularly limited, but is, for example, about 1 to 10 mm. The proximal end portion of the sheath tube 2 is fixed to the hub 3.

  The hub 3 includes a hub body 31 that has a substantially cylindrical shape, a side port (connection port) 32 that protrudes from the outer periphery of the hub body 31, and a valve body 33.

  The hub body 31 has a lumen 30. The lumen portion 30 communicates with the lumen portion 20 of the sheath tube 2.

  The side port 32 has a cylindrical shape, and the central axis thereof is provided in a direction orthogonal to the central axis of the hub body 31. Further, the inside of the side port 32 is a branch channel 320 branched from the lumen portion 30. The side tube 5 is fixed to the side port 32.

  As shown in FIGS. 2 and 3, a valve body 33 is provided inside the hub body 31 and in the vicinity of the proximal end opening. The valve body 33 is configured by a member having a circular film shape (disk shape), and an outer peripheral portion thereof is liquid-tightly fixed to the inner surface of the hub body 31. Thereby, the valve body 33 can prevent leakage of liquid such as blood from the proximal end of the hub body 31.

  The valve body 33 is formed of a film-like elastic body, and is formed with a slit 331 that reaches only one surface (right surface) and a slit 332 that reaches only the other surface (left surface), and These are partially crossed inside. The slits 331 and 332 function as openable / closable opening / closing holes.

  The constituent material of the valve body 33 is not particularly limited, and examples thereof include silicone rubber, latex rubber, butyl rubber, and isoprene rubber.

  A constituent material of the hub 3 (excluding the valve body 33) is not particularly limited, but a hard material such as a hard resin is suitable. Specific examples of the hard resin include polyolefin such as polyethylene and polypropylene, polyamide, polycarbonate, polystyrene, and the like.

  As shown in FIGS. 1 to 3, the side tube 5 is fixed to the side port 32.

  As shown in FIG. 1, the side tube 5 has a side tube main body 51 and a three-way cock 52.

  The side tube main body 51 has flexibility and is softer than the sheath tube 2. The constituent material of the side tube 5 is not particularly limited, and for example, a soft resin such as polyvinyl chloride can be used.

  The three-way stopcock 52 is attached to the other end of the side tube body 51. Priming can be performed by injecting a liquid such as physiological saline into the introducer sheath 1 from the predetermined port of the three-way stopcock 52 through the side tube 5.

  As shown in FIG. 1, the introduction needle assembly 6 is formed of a hollow needle having a sharp tip. The introduction needle assembly 6 has a double tube structure constituted by an inner tube 61 and an outer tube 62. The inner tube 61 and the outer tube 62 are slidable along their longitudinal directions.

  A hub 63 is provided at the proximal end portion of the inner tube 61. The hub 63 has a function of contacting the proximal end portion of the outer tube and preventing the outer tube 62 from moving toward the proximal end side with respect to the inner tube 61. Thereby, the living body can be punctured in the assembled state.

  Further, the outer tube 62 has a ruled line 621 as a fracture portion. A pair of the ruled lines 621 are provided via the central axis of the outer tube 62. Each ruled line 621 is formed from the distal end to the proximal end of the outer tube 62 along the longitudinal direction of the outer tube 62. The outer tube 62 is configured to be disassembled into a vertical half by pulling the two divided parts in opposite directions through the ruled line 621.

Next, the guide member 4 will be described.
The guide member 4 includes an elongated wire body 41 having flexibility, a diameter-expanded portion 42 provided in the middle of the wire body 41 in the longitudinal direction, and a hub 43 provided at a proximal end portion of the wire body 41. have.

  The wire body 41 is a wire made of a superelastic alloy (alloy exhibiting pseudoelasticity) such as a Ni—Ti alloy.

  The enlarged diameter portion 42 is a portion whose outer diameter is larger than that of the wire body 41. The enlarged diameter portion 42 is a step between the guide member 4 and the sheath tube 2 when the guide member 4 is protruded from the distal end opening 22 of the sheath tube 2 in the assembled state in which the guide member 4 is inserted into the sheath tube 2. It functions as a step mitigation mechanism that relaxes. The enlarged diameter portion 42 can be divided into a distal side taper portion 421 whose outer diameter gradually decreases toward the distal end side and a proximal end side taper portion 422 whose outer diameter gradually decreases toward the proximal end side. Further, the boundary portion 423 between the distal end side taper portion 421 and the proximal end side taper portion 422 is a portion having the largest outer diameter in the enlarged diameter portion 42, and the outer diameter thereof is the sheath tube 2, It is a diameter that fills a step with the wire body 41. More preferably, the outer diameter of the boundary portion 423 is the same as the inner diameter of the sheath tube 2.

The outer diameter (maximum outer diameter) φD ₁ of the wire body 41 is not particularly limited, but is, for example, about 0.5 to 2 mm. The outer diameter [phi] D ₂ of the boundary portion 423 is not particularly limited, for example, about 1 to 10 mm.
The enlarged diameter portion 42 is preferably configured integrally with the wire main body 41.

  As shown in FIG. 1, the hub 43 has a larger outer diameter than the proximal end opening 34 of the hub 3. For this reason, the hub 43 abuts on the base end surface of the hub 3 and has a function of preventing the guide member 4 from being inserted further into the distal end side. That is, the hub 43 functions as a positioning portion that positions the guide member 4 with respect to the introducer sheath 1 in the assembled state.

  As shown in FIGS. 1 and 3, the tip side taper portion 421 protrudes from the tip opening 22 of the sheath tube 2 in the assembled state. Further, the proximal end of the distal end side taper portion 421, that is, the boundary portion 423 coincides with the distal end opening 22 in the longitudinal direction. For this reason, in the assembled state, the boundary portion 423 comes into close contact with the inner peripheral portion of the distal end of the sheath tube 2.

  As shown in FIG. 3, when inserted into the living body in the assembled state, first, the living tissue 300 is gradually expanded (primary expansion) by the distal side taper portion 421. Next, the sheath side taper portion 21 expands (secondary expansion) the portion where the tip side taper portion 421 has expanded. Thus, by expanding the biological tissue 300 in stages, it is possible to suppress the biological tissue 300 from being sharply expanded as much as possible. Therefore, the burden on the living tissue 300 can be reduced.

  In particular, in the assembled state, since the boundary portion 423 is in close contact with the inner peripheral portion of the distal end of the sheath tube 2, when the introducer sheath set 10 is inserted into the living body in the assembled state, the resistance received from the living tissue 300 causes the sheath tube It is possible to reliably prevent the tip of 2 from being turned to the outer peripheral side. Therefore, it is possible to reliably prevent the living tissue 300 from being damaged by the turned portion. As a result, the burden on the living tissue 300 can be more reliably reduced.

  If the enlarged diameter portion 42 is omitted, the distance G between the outer peripheral portion of the wire body 41 and the inner peripheral portion of the sheath tube 2 indicated by a two-dot chain line in FIG. For this reason, a comparatively big level | step difference is formed. Conventionally, a dilator is used separately from the guide member 4 and the introducer sheath 1 in order to alleviate this step. On the other hand, in this invention, the diameter expansion part 42 functions as a relaxation part which relieves a level | step difference. For this reason, the conventionally used dilator can be omitted. Therefore, one medical tool used for the procedure can be reduced, and the procedure is simplified. As a result, the procedure can be performed easily and smoothly.

  Moreover, although the diameter-expanded part 42 is good also as a structure which can be formed over the perimeter direction along the central axis of the wire main body 41, the structure is not specifically limited. That is, the diameter-expanded portion 42 may be a structure having a diameter that contacts a part of the inner peripheral surface of the sheath tube 2. As described above, in the present invention, it becomes a problem to fill the step between the wire main body 41 and the sheath tube 2 that occurs when the wire main body 41 is inserted into the sheath tube 2, but by adopting such a configuration, The enlarged diameter portion 42 can sufficiently exhibit the function as a relaxing portion that fills the step with the sheath tube 2.

Further, the taper angle theta ₂ of the distal end taper portion 421, it is better moderate, for example, is preferably from 1 to 30 °, and more preferably 3 to 8 °. Thereby, when inserting in the living body, the living tissue 300 can be gently expanded by the tip side taper portion 421. Therefore, the burden on the living tissue 300 can be further reduced.

Further, the length _{L 1} of the distal end taper portion 421, and the length _{L 2} of the base-end taper portion 422, may be different even in the same, for example, about 1～40Mm.

  Here, FIGS. 4A to 4C are views showing a state where the guide member 4 is pulled out from the introducer sheath 1 to the proximal end side. When the guide member 4 is further pulled toward the base end side from the state shown in FIG. 4A, the enlarged diameter portion 42 pushes the slit wide as shown in FIG. 4B. At this time, the slits 331 and 332 are gradually pushed and widened by the proximal end side tapered portion 422. For this reason, it is possible to prevent the enlarged diameter portion 42 from being caught in the slits 331 and 332 and forcibly trying to pull out the slits 331 and 332 and damaging the slit. Therefore, the reproducibility of the self-blocking of the slits 331 and 332 can be improved. When the boundary portion 423 passes through the slits 331 and 332, the slits 331 and 332 are slowly closed by the tip side taper portion 421 (see FIG. 4C).

In the present embodiment, the taper angle θ ₃ of the proximal end side taper portion 422 is the same as the taper angle θ ₂ of the distal end side taper portion 421.

That the taper angle of the front end side taper part 421 and the base end side taper part 422 is the same, in other words, in the enlarged diameter part 42, the shape in the front and back is the same with the boundary part 423 as a boundary. That is, the length L ₂ of the length L ₁ and the base-end taper portion 422 of the distal end taper portion 421 are the same. For this reason, for example, when the diameter-enlarged portion 42 is formed by inserting a cylindrical member formed separately from the wire main body 41 into the outer peripheral portion of the wire main body 41, regardless of the front or rear of the cylindrical member. The cylindrical member may be inserted through the wire main body 41 from the direction of. Therefore, the process of inserting the cylindrical member into the wire body 41 can be easily performed, and the productivity is excellent.

  Next, the usage method (procedure) of the introducer sheath set 10 will be described. Below, the case where the introducer sheath set 10 is used for performing catheter treatment from the radial artery 200 will be described as an example. As this catheter treatment, for example, a drug is directly administered to an affected part (lesioned part) via a catheter, and a stenotic part in a blood vessel is expanded by using a catheter attached to a tip of a balloon that is expanded by pressurization. Treatment that opens and cuts off the affected part by using a catheter with a cutter attached to the tip, and conversely treatment that closes the aneurysm, bleeding site, or feeding vessel using a catheter.

[Procedure 1]
First, as shown in FIG. 5, radial artery 200 is punctured from living body surface 100 using introduction needle assembly 6. When blood flashback is confirmed from the proximal end opening of the introduction needle assembly 6, it can be seen that the needle tip has pierced the radial artery 200.

[Procedure 2]
Next, as shown in FIG. 6, the inner tube 61 is removed from the outer tube 62, and only the outer tube 62 is left in the living body.

[Procedure 3]
Then, as shown in FIG. 7, the assembled introducer sheath set 10 is inserted into the living body via the outer tube 62. This insertion is performed until the guide member 4 protrudes from the distal end of the outer tube 62 and the guide member 4 is located in the radial artery 200.

[Procedure 4]
Next, as shown in FIG. 8, the outer tube 62 is detached from the living body and divided. As a result, only the guide member 4 is placed in the living body. In addition, since the outer tube 62 is divided and configured to be detachable from the guide member 4, a troublesome operation of temporarily removing the introducer sheath set 10 from the outer tube 62 can be omitted.

[Procedure 5]
Then, as shown in FIG. 9, the introducer sheath set 10 is inserted into the radial artery 200. At this time, as described above, since the diameter-expanded portion 42 of the guide member 4 functions as a conventionally used dilator, the dilator can be omitted in the present invention. Therefore, one medical tool used for the procedure can be reduced, and the procedure is simplified. As a result, the procedure can be performed easily and smoothly.

[Procedure 6]
Next, as shown in FIG. 10, the guide member 4 is removed from the introducer sheath 1. At this time, as described above, the proximal side taper portion 422 can prevent the slits 331 and 332 from being damaged.

  And although not shown in figure, a catheter is inserted in a radial artery via the introducer sheath 1, and predetermined treatment is performed.

Second Embodiment
FIG. 11 is an enlarged cross-sectional view showing an assembled state of the introducer sheath set (second embodiment) of the present invention.

Hereinafter, a second embodiment of the introducer sheath set according to the present invention will be described with reference to this figure. However, the difference from the above-described embodiment will be mainly described, and description of similar matters will be omitted.
This embodiment is substantially the same as the first embodiment described above except that the configuration of the enlarged diameter portion is different.

  As shown in FIG. 11, the expanded diameter portion 42 of the introducer sheath set 10 </ b> A has an outer diameter constant portion 424 having a constant outer diameter in addition to the distal end side tapered portion 421 and the proximal end side tapered portion 422.

  The outer diameter constant portion 424 is located between the distal end side tapered portion 421 and the proximal end side tapered portion 422. That is, the tip side taper portion 421, the constant outer diameter portion 424, and the base end side taper portion 422 are arranged in this order from the tip side. Further, the outer diameter of the constant outer diameter portion 424 is the maximum outer diameter of the enlarged diameter portion 42.

  According to such introducer sheath set 10A, when inserted into a living body in an assembled state, first, the distal side taper portion 421 of the living tissue 300 is gradually expanded (primary expansion). Next, the outer diameter constant portion 424 maintains the portion where the tip side taper portion 421 is expanded for a certain time. The expanded state is maintained (secondary expansion) by the sheath-side taper portion 21 after the expanded state is maintained for a certain period of time by the constant outer diameter portion 424. Thus, according to the introducer sheath set 10A, the secondary expansion can be performed after a certain period of time after the primary expansion. Thereby, it is possible to further suppress the rapid expansion of the living tissue 300. Therefore, the burden on the living tissue 300 can be further reduced.

  As mentioned above, although the introducer sheath set of the present invention has been described with respect to the illustrated embodiment, the present invention is not limited to this, and each part constituting the introducer sheath set is an arbitrary element that can exhibit the same function. It can be replaced with the configuration of Moreover, arbitrary components may be added. For example, the guide member 4 shown in the drawing is composed only of the wire body 41 and the enlarged diameter portion 42, but the present invention is not limited to this, and the proximal end side of the enlarged diameter portion 42 is not a wire. There is no problem. In other words, the base end side of the enlarged diameter portion 42 may have a structure that extends to the base end side with the enlarged diameter. The hub 43 may or may not be movable. Furthermore, you may have a mechanism which can be fixed with respect to the hub 3 located in the base end side of the introducer sheath 1. FIG.

  In each of the above-described embodiments, the introducer sheath set has been described as being inserted into the radial artery for use. However, the present invention is not limited to this. For example, the introducer sheath set may be inserted into the right femoral artery, the right upper arm artery, or the like. Can also be used.

  In each of the above embodiments, the case where the taper angle of the distal end side taper portion and the proximal end side taper portion is the same has been described. However, the present invention is not limited to this, for example, the direction of the taper angle of the distal end side taper portion May be large, and the taper angle of the proximal end side tapered portion may be larger.

  Further, in each of the above embodiments, a slit that reaches only one surface and a slit that reaches only the other surface are formed, and those that partially intersect inside, or a check valve However, in the present invention, the present invention is not limited to this. For example, a Y-shaped slit or a multi-layered one, a duck bill valve having a cross-shaped or single-character slit, and the like. A known valve body can also be used.

10, 10A Introducer sheath set 1 Introducer sheath 2 Sheath tube 20 Lumen portion 21 Sheath side taper portion 22 Tip opening 3 Hub 30 Lumen portion 31 Hub body 32 Side port 320 Branch flow path 33 Valve element 331 Slit 332 Slit 34 Base end opening 4 Guide member 41 Wire body 42 Expanded portion 421 Tip side taper portion 422 Base end side taper portion 423 Boundary portion 424 Outer diameter constant portion 43 Hub 5 Side tube 51 Side tube body 52 Three-way stopcock 6 Indwelling needle assembly 61 Inner tube 62 Outer tube 621 Ruled line 63 Hub 100 Biological surface 200 Radial artery 300 Biological tissue G Distance L ₁ length L ₂ length L ₃ length θ ₁ taper angle θ ₂ taper angle θ ₃ taper angle φD ₁ outer diameter φD ₂ Outer diameter

Claims (8)

A guide member having a flexible long wire main body, a guide member that is provided at a predetermined position in the longitudinal direction of the wire main body, and has an enlarged outer diameter; An introducer sheath set comprising an introducer sheath having a lumen through which a member is inserted,
In the assembled state in which the guide member is inserted through the introducer sheath, a step difference is eased by reducing the step between the guide member and the outer peripheral surface of the introducer sheath in the enlarged diameter portion protruding from the tip opening. An introducer sheath set comprising a mechanism.   2. The introducer sheath set according to claim 1, wherein the step reducing mechanism in the enlarged diameter portion includes a tapered portion in which an outer diameter of the enlarged diameter portion gradually decreases from a proximal end side toward a distal end side. The introducer sheath has a sheath side taper portion whose outer diameter gradually decreases toward the distal end side at the distal end portion thereof,
The introducer sheath set according to claim 2, wherein the taper portion has a smaller taper angle than the sheath-side taper portion.   The introducer sheath set according to claim 2 or 3, wherein the step reducing mechanism in the enlarged diameter portion has a constant outer diameter portion having a constant outer diameter on the proximal end side with respect to the tapered portion. The introducer sheath has a valve body that is provided on the inner peripheral portion of the base end, is configured by a film-like elastic body, and has an openable opening / closing hole that penetrates in the thickness direction thereof.
The enlarged diameter portion is provided on the proximal end side of the tapered portion, and has a proximal end side tapered portion whose outer diameter gradually decreases from the distal end side toward the proximal end side,
The base end side taper portion has a function of preventing the diameter-expanded portion from being caught in the opening / closing hole when the guide member is removed from the introducer sheath. The introducer sheath set according to item.   In the state where the guide member is protruded from the introducer sheath, the step reducing mechanism in the enlarged diameter portion is arranged in the order of the tapered portion, the outer diameter constant portion, and the sheath side tapered portion from the distal end side. The introducer sheath set according to claim 5.   The said guide member is provided in the base end part of the said wire main body, and has the positioning part which enables relative positioning of the said enlarged diameter part with the said introducer sheath in the longitudinal direction. The introducer sheath set according to any one of the above.   Prior to inserting the assembly in which the guide member and the introducer sheath are assembled into the blood vessel, the blood vessel is punctured, and the guide member and the introducer sheath are inserted in the punctured state. The introducer sheath set according to any one of claims 1 to 7, further comprising a tubular puncture needle.

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