JP2005058304A - Introducer sheath - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an introducer sheath capable of easily securing a blood vessel with less puncturing resistance in insertion to the blood vessel, hardly generating crushing and bending (kinks) even when the blood vessel at an insertion part meanders and capable of reducing pains given to a patient in the insertion to the blood vessel or detention. <P>SOLUTION: This introducer sheath 1 is provided with a sheath tube 2 composed of: an inner layer tube 6; a filament 9 helically wound around the outer surface of the inner layer tube 6 and formed of a resin; and an outer layer tube 10 provided on the outer side of the filament 9. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to an introducer sheath used for inserting a catheter into a body lumen such as a blood vessel.

  In recent years, various forms of treatment have been performed in medicine using an elongated hollow tubular medical device called a catheter. Such treatment methods include the method of administering a drug directly to the affected area using the longness of the catheter, and the use of a catheter attached to the tip of a balloon that is expanded by pressurization to push the stenotic part in the blood vessel. There are a method of opening, a method of scraping and opening the affected part using a catheter with a cutter attached to the tip, and a method of closing the aneurysm, bleeding site or feeding blood vessel using a catheter. Alternatively, in order to maintain the stenosis in the blood vessel in an open state, there is a treatment method in which a tube-shaped stent having a meshed side surface is implanted in a blood vessel using a catheter.

  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. In this method, a puncture needle such as an indwelling needle is percutaneously inserted into a blood vessel, and a guide wire is inserted into the inner tube of the puncture needle from the rear end. Next, the puncture needle is extracted, and a sheath tube, which is an elongated hollow tubular body of the introducer sheath, is inserted percutaneously along the guide wire. At this time, a dilator is inserted and set in the sheath tube. As a result, the percutaneous insertion port is expanded, the guide wire and the dilator are removed, and then the catheter is inserted through the sheath tube.

  A sheath tube of such an introducer sheath has been conventionally formed of a synthetic resin such as polyamide, polypropylene, fluorine resin, or polyurethane. However, if the sheath tube made of synthetic resin is formed thick enough to have the strength required as an introducer sheath, the puncture resistance will increase, and the distal end of the sheath tube will be damaged during insertion or blood vessels cannot be secured There was a thing. On the other hand, if it is thin to reduce puncture resistance, the sheath tube becomes fragile, and the distal end of the sheath tube is easily damaged when inserted into a blood vessel. When the blood vessel is meandering, the sheath tube may be crushed or bent (kink), which may make it difficult to insert and operate the catheter.

  Therefore, in order to solve such a problem of the sheath tube being crushed or kinked, a sheath tube is disclosed in which a SUS coil is provided as a reinforcing coil between the resin inner and outer layers to improve the kink resistance ( Patent Document 1). However, since a metal coil such as SUS has a high tensile elastic modulus and is rigid, there is a problem that when the sheath tube is crushed once, plastic deformation occurs and it is difficult to restore the original shape. In addition, when processing the tip of the sheath tube into a tapered shape in order to eliminate the step with the dilator, a tip material that does not include a reinforcing body is used to prevent the metal coil from being exposed on the outer surface of the sheath tube. It is indispensable to join to the front end side.

JP-A-7-303703

  Accordingly, an object of the present invention is to provide a blood vessel that can be easily secured with little puncture resistance when inserted into a blood vessel, and is less likely to be crushed or bent (kink) even if the blood vessel at the insertion site is meandering. It is an object of the present invention to provide an introducer sheath that is less painful to the patient during insertion or placement into the patient.

  Such an object is achieved by the present inventions (1) to (13) below.

(1) an inner layer tube;
A filament formed of resin wound spirally around the outer surface of the inner layer tube;
An introducer sheath comprising a sheath tube comprising an outer layer tube provided outside the filament.

(2) The introducer sheath according to (1), wherein a tensile elastic modulus of the resin forming the filament is 500 to 20000 MPa.

(3) The introducer sheath according to (1), wherein the resin forming the filament is any one of a fluororesin, polyamide, polyolefin, polyester, and polyphenylene sulfide.

(4) The introducer sheath according to any one of (1) to (3), wherein the filament has a multilayer structure.

(5) The introducer sheath according to (1), wherein the resin forming the filament contains reinforcing short fibers or layered silicate.

(6) The introducer sheath according to (5), wherein the short fiber is any one of carbon fiber, organic fiber, inorganic fiber, metal fiber, carbon nanotube, and carbon nanofiber.

(7) The introducer sheath according to any one of (1) to (6), wherein the inner layer tube includes an inner layer body and an adhesive layer provided on an outer surface of the inner layer body.

(8) The introducer sheath according to (7), wherein the inner layer body is made of polyolefin or fluororesin.

(9) The introducer sheath according to (7), wherein the adhesive layer contains at least an adhesive polyolefin.

(10) The introducer sheath according to any one of (1) to (6), wherein an outer surface of the inner layer tube is chemically etched.

(11) The introducer sheath according to any one of (1) to (10), wherein the outer layer tube is made of any one of polyolefin, polyamide, polyurethane, polyester, and fluorine resin.

(12) The introducer sheath according to any one of (1) to (11), wherein a distal end tip is joined to a distal end side of the sheath tube.

(13) The introducer sheath according to any one of (1) to (12), wherein a radiopaque marker is provided on a distal end side of the filament.

  The introducer sheath of the present invention comprises a sheath tube comprising an inner layer tube, a filament formed of resin spirally wound around the outer surface of the inner layer tube, and an outer layer tube provided outside the filament. Therefore, the blood vessel can be easily secured with little puncture resistance when inserted into the blood vessel. And even if the blood vessel of the insertion site is meandering, it is difficult to cause crushing or kinking. Therefore, the patient is less painful during insertion or placement in the blood vessel.

  Further, in the case where the tip is joined to the distal end side of the sheath tube, damage to the blood vessel into which the sheath tube is inserted is prevented.

  Further, when a radiopaque marker is provided on the distal end side of the filament, the position of the distal end of the sheath tube can be easily confirmed under fluoroscopy.

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

<First Embodiment>
FIG. 1 is an overall view showing a first embodiment of the introducer sheath of the present invention, and FIG. 2 is a longitudinal sectional view showing a sheath tube of the introducer sheath of FIG. Hereinafter, the right side in FIGS. 1 and 2 will be described as the “base end” and the left side as the “tip”.

  The introducer sheath 1 of the present invention has a hollow structure communicating with a lumen 5 of the sheath tube 2 and a lumen 5 of the sheath tube 2, which is a long hollow tubular body having a distal end 3 and a proximal end 4. A hub 11 connected to the proximal end 4 of the tube 2 is provided.

  The sheath tube 2 is composed of an inner layer tube 6, a filament 9 formed of a resin spirally wound around the outer surface of the inner layer tube 6, and an outer layer tube 10 provided outside the filament 9. Further, the inner layer tube 6 includes an inner layer main body 7 and an adhesive layer 8 provided outside the inner layer main body 7.

  The inner layer main body 7 extends over the entire length from the proximal end 4 to the distal end 3 of the sheath tube 2, and forms a lumen 5 of the sheath tube 2. Such an inner layer body 7 is formed of a low friction material. For this reason, the frictional force is reduced on the inner surface of the inner layer main body 7. Thereby, the insertion of the dilator or the catheter into the lumen 5 and the extraction operation from the lumen 5 can be easily performed.

  The material for forming the inner layer main body 7 is not particularly limited as long as it reduces the frictional force of the inner surface of the inner layer main body 7. For example, a fluorine-based resin such as polytetrafluoroethylene, ethylene-tetrafluoroethylene copolymer, Examples thereof include polyolefins such as high density polyethylene and polypropylene, and nylon 66. Among these, high density polyethylene excellent in adhesiveness with a material for forming the adhesive layer 8 described later is particularly preferable.

  The thickness of the inner layer body 7 is not particularly limited, but is preferably 0.015 to 0.050 mm, for example. If the wall thickness exceeds 0.050 mm, the outer diameter of the sheath tube 2 inevitably increases, so that the puncture resistance during insertion into the blood vessel increases, which may be painful to the patient. Further, when the wall thickness is less than 0.015 mm, the frictional force on the inner surface of the inner layer body 7 may not be reduced.

  Further, silicon or the like may be applied to the inner surface of the inner layer body 7. Thereby, the frictional force is further reduced on the inner surface of the inner layer main body 7.

  An adhesive layer 8 is provided on the outer side of the inner layer body 7 to improve the adhesion of the inner layer body 7 to the outer layer tube 10.

  The material for forming the adhesive layer 8 is not particularly limited as long as it has adhesiveness with the inner layer body 7 and the outer layer tube 10, but for example, maleic anhydride, acrylic acid, polyethylene modified with an epoxy group, etc. Adhesive polyolefin is mentioned. The adhesive layer 8 may be formed of only such an adhesive polyolefin, and the adhesive layer 8 may be formed by containing the same material as that of the outer tube 10 described later in the adhesive polyolefin. It may be formed to improve the adhesion with the outer tube 10.

  Although the thickness of the contact bonding layer 8 is not specifically limited, For example, it is preferable that it is 0.015-0.050 mm. When the wall thickness exceeds 0.050 mm, the outer diameter of the sheath tube 2 inevitably increases, so that the puncture resistance when inserted into a blood vessel increases, which may be painful to the patient. Further, when the wall thickness is less than 0.015 mm, the adhesion to the outer tube 10 may not be exhibited.

  Note that the adhesive layer 8 does not necessarily have to be provided on the outer side of the inner layer main body 7. For example, minute unevenness may be formed on the outer surface of the inner layer main body 7 by chemical etching to improve the adhesion with the outer layer tube 10. .

  A filament 9 formed of resin is spirally wound around the outer surface of the adhesive layer 8, that is, the inner layer tube 6 at a winding pitch of approximately equal intervals.

  In the present specification, the winding pitch means the distance in the longitudinal direction of the sheath tube 2 between adjacent windings (windings) forming the filament 9 as shown in FIG. It means the length between adjacent windings (windings) and windings (windings) in the longitudinal direction of the tube 2.

  The winding pitch of the filament 9 is not particularly limited, but is preferably 0.1 to 0.5 mm. When the winding pitch is 0.5 mm or more, the kink resistance of the sheath tube 2 itself becomes insufficient, and when the sheath tube 2 is inserted into a meandering blood vessel, crushing or kinking is likely to occur. Further, when the winding pitch is 0.1 mm or less, the sheath tube 2 itself becomes hard, and it becomes difficult to insert into the meandering blood vessel. Moreover, since the adhesiveness (adhesiveness) between the adhesive layer 8 and the outer layer tube 10 is lowered, delamination easily occurs between the inner layer tube 6 and the outer layer tube 10.

  The material for forming the filament 9 is not particularly limited as long as it is a resin. For example, a fluororesin such as polytetrafluoroethylene, an ethylene-tetrafluoroethylene copolymer, or polyvinylidene fluoride, a polyolefin such as polyamide, polyethylene, or polypropylene, or a polyethylene Examples thereof include polyesters such as terephthalate and polybutylene terephthalate, and polyphenylene sulfide.

  The tensile modulus of the filament 9 is preferably, for example, 500 to 20000 MPa. When the tensile elastic modulus is 500 MPa or less, the kink resistance of the sheath tube 2 becomes insufficient, and when the sheath tube 2 is inserted into a meandering blood vessel, crushing or kinking is likely to occur. Further, when the tensile elastic modulus is 20000 MPa or more, when the lumen 5 of the sheath tube 2 is once collapsed, plastic deformation occurs and it is difficult to restore the original shape.

  The cross-sectional shape of the filament 9 includes, for example, a flat shape, that is, a ribbon (band-like) shape in addition to the circular shape shown in FIG.

  When the cross-sectional shape of the filament 9 is circular, the diameter is preferably 0.03 to 0.15 mm. Moreover, when the cross-sectional shape of the filament 9 is a ribbon shape, the width is preferably 0.1 to 1.0 mm and the thickness is preferably 0.03 to 0.10 mm.

  Between the adjacent windings of the filament 9, the adhesive layer 8 penetrates. As a result, the filament 9 maintains a constant pitch winding and has a stable kink resistance.

  The distal end of the filament 9 is located on the proximal end side of the distal end 3 of the sheath tube 2, that is, the distal end of the inner layer tube 6, and a portion where the filament 9 does not exist is formed at the distal end 3 of the sheath tube 2. ing. As a result, the distal end 3 of the sheath tube 2 is more flexible than other portions, and damage to the blood vessel into which the sheath tube 2 is inserted is prevented.

  In FIG. 2, a single filament 9 is wound around the outer surface of the adhesive layer 6. However, the present invention is not limited to this. For example, two or more filaments 9 are laminated in two or more layers. It may be wound around the outer surface.

  In addition, reinforcing short fibers or layered silicate (not shown) may be contained (dispersed) in the resin forming the filament 9. In the present specification, the layered silicate means a layer having a structure composed of a negatively charged layer mainly composed of silicate and a specific positive charge interposed therebetween. By uniformly dispersing such short fibers or layered silicate in the resin forming the filament 9, the tensile strength and bending strength of the filament 9 are increased, and the sheath tube 2 has kink resistance and crush resistance. Further improve.

  Examples of short fibers include carbon fibers such as carbon short fibers and carbon whiskers, liquid crystal polyester fibers, aramid short fibers, polyethylene short fibers, polyoxymethylene short fibers, polyvinyl alcohol short fibers, and other organic fibers, potassium titanate short fibers, Examples include inorganic fibers such as silicon carbide short fibers, alumina short fibers and glass short fibers, boron short fibers, titanium alloy short fibers, steel short fibers, metal fibers such as aluminum alloy short fibers, carbon nanotubes, and carbon nanofibers. .

  Although the fiber length of the short fiber is not particularly limited, it is preferably 5 mm or less, more preferably 3 mm or less, and still more preferably 1 mm from the viewpoint that the resin forming the filament 9 is sufficiently impregnated between the fibers. It is as follows. Further, the aspect ratio of the short fiber (ratio of the fiber length to the fiber diameter) is not particularly limited, but is preferably 10 times or more, more preferably 30 times from the viewpoint that sufficient tensile strength and bending strength can be obtained. Above, more preferably 100 times or more.

  Examples of layered silicates include smectites such as montmorillonite, hydelite, saponite, hectorite, and soconite, vermiculites, fluoromica, muscovite, paragonite phlogopite, biotite, lepidite, and other mica, margarite, Examples include brittle mica such as clintnite and anandite, chlorite such as donbasite, sudite, kukeaite, clinochlore, chamosite and nimite. These may be natural compounds, artificially synthesized or modified, or partially treated with an organic compound such as an onium salt. Of these, the fluorinated mica-based minerals are particularly preferable from the viewpoint of whiteness, and the fluorinated mica-based minerals are easily synthesized.

  The average particle size of the layered silicate is preferably 5 μm or less. If the average particle diameter exceeds 5 μm, the layered silicate cannot be uniformly dispersed in the resin forming the filament 9, and this is undesirable because it causes unevenness on the yarn.

  An outer tube 10 is provided outside the filament 9 and completely covers the filament 9. The outer tube 10 is completely in close contact with the filament 9 and compresses the filament 9 toward the adhesive layer 8 side. Further, the outer layer tube 10 is in close contact (adhesion) with the adhesive layer 8 between adjacent windings (windings) and windings (windings) of the filament 9.

  The material for forming the outer tube 10 is not particularly limited. For example, polyolefin such as polyethylene and polypropylene, polyamide such as nylon 12, polyamide elastomer, polyurethane, polyethylene terephthalate, polyester such as polybutylene terephthalate, polyester elastomer, fluorine resin, etc. Various resin materials or a mixture of two or more of these resin materials can be used.

  Although the wall thickness of the outer layer tube 10 is not specifically limited, For example, it is preferable that it is 0.03-0.30 mm. When the wall thickness exceeds 0.30 mm, the outer diameter of the sheath tube 2 inevitably increases, so that the puncture resistance when inserted into the blood vessel increases, which may be painful to the patient. Further, when the wall thickness is less than 0.03 mm, the outer tube 10 cannot completely cover the filament 9, and the filament 9 is exposed on the outer surface of the sheath tube 2, so that the outer surface of the sheath tube 2 is uneven. There is.

  The outer tube 10 may contain particles made of a radiopaque material. By including the X-ray impermeable material, the visibility of the sheath tube 2 under X-ray fluoroscopy is improved. Examples of such radiopaque materials include bismuth oxide and barium sulfate.

  Although the length of the sheath tube 2 is not specifically limited, Preferably it is 30-500 mm, More preferably, it is 50-300 mm. The inner diameter of the sheath tube 2 is not particularly limited, but is preferably 0.7 to 10 mm, more preferably 0.9 to 4.5 mm. The outer diameter of the sheath tube 2 is not particularly limited, but is preferably 0.8 to 11 mm, and more preferably 1.0 to 5.0 mm. The thickness of the sheath tube 2 is not particularly limited, but is preferably 0.1 to 0.5 mm, and more preferably 0.15 to 0.3 mm.

  Further, the distal end 3 of the sheath tube 2 is tapered. As a result, the level difference from the dilator (not shown) inserted / set in the lumen 5 is reduced, and thus the blood vessel can be easily secured with little puncture resistance when inserted into the blood vessel.

  In the present invention, it is preferable that a hydrophilic polymer material is applied to the outer surface of at least the distal end side of the sheath tube 2, that is, the outer layer tube 10. 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. Insertability into meandering blood vessels is further enhanced.

  Such a hydrophilic polymer material is not particularly limited. For example, a cellulose polymer material (for example, hydroxypropylcellulose), a polyethylene oxide polymer material (for example, polyethylene glycol), a maleic anhydride polymer material (for example, methyl). Vinyl ether-maleic anhydride copolymer), acrylamide polymer substances (for example, acrylamide-glycidyl methacrylate copolymer), water-soluble nylon and the like.

  A hub 11 having a hollow structure communicating with the lumen 5 is connected to the proximal end 4 of the sheath tube 2. In FIG. 1, the distal end portion 12 of the hub 11 having a hollow structure is inserted into the opening of the proximal end 4 of the sheath tube 2 so that the hollow structure of the hub 11 and the lumen 5 of the sheath tube 2 communicate with each other. The distal end portion 12 of the hub 11 and the proximal end 4 of the sheath tube 2 are connected. Although the material which forms such a hub 11 is not specifically limited, For example, polyolefin, such as polyethylene and a polypropylene, polyamide, a polycarbonate, a polystyrene etc. are mentioned.

  The introducer sheath 1 of the present invention may further include other elements as a structure relating to the connection between the proximal end 4 of the sheath tube 2 and the distal end portion 12 of the hub. For example, in FIG. 1, a support body 14 that prevents kinking of the sheath tube 2 is provided on the outer periphery of the connection portion between the distal end portion 12 of the hub 11 and the proximal end 4 of the sheath tube 2. Although the material which forms such a support body 14 is not specifically limited, For example, thermoplastic elastomers, such as a styrene-type elastomer, an olefin-type elastomer, and a polyester elastomer, are mentioned.

  In the sheath introducer 1 of the present invention, a valve body (not shown) for preventing leakage of liquid such as blood is provided at the proximal end portion 13 of the hub 11. Although the material which forms such a valve body is not specifically limited, For example, silicon | silicone, latex, butyl rubber, isoprene rubber etc. are mentioned. In addition, the most common structure of the valve body is a valve body that has a cross slit shape on one side and the other side and intersects only inside. Is not particularly limited, and may be, for example, a multi-layered Y-shaped slit, a cross, a single-slit duckbill valve, or other known valve bodies.

  A branch part 15 is formed on the side surface of the hub 11 to communicate the hollow structure of the hub 11 with the outside. The branch part 15 is further connected to one end of a branch pipe 16 that is a hollow tubular body. ing. A three-way cock 17 is attached to the end of the branch pipe 16 on the side where the branch part 15 is not connected.

  The sheath tube 2 of the introducer sheath 1 of the present invention can be manufactured, for example, as follows. First, the inner layer body 7 and the adhesive layer 8 are formed by coextrusion by wire coating. Further, the outer tube 10 is formed as a hollow tubular body by hollow extrusion molding.

  Next, the filament 9 made of resin is spirally wound around the outer periphery of the adhesive layer 8, and the filament 9 is provided on the outer surface of the adhesive layer 8 (inner layer tube 6). At this time, the filament is wound around the outer surface of the adhesive layer 8 while applying a predetermined winding tension to the filament. Thereby, the adhesive layer 8 is compressed by the winding (winding) of the filament 9, and the adhesive layer 8 enters between the adjacent windings (winding) of the filament 9.

  Then, the outer layer tube 10 is put on the adhesive layer 8 around which the filament 9 is wound. Next, a heat-shrinkable tube made of, for example, a fluororesin is placed on the outside of the outer layer tube 10, and this is heated and thermally shrunk. As a result, the outer layer tube 10 is melted and flows (invades) between the adjacent windings (windings) of the filaments 9 and adheres (adheres) to the outer surface of the adhesive layer 8.

  Thereafter, the heat shrinkable tube is removed, and the end portion (portion unnecessary as the sheath tube 2) is cut. Before and after this, the electric wire is pulled out from the inner layer main body 7. In addition, as another manufacturing method of the outer layer tube 10, for example, a material for forming the outer layer tube 10 is coated on the outside of the adhesive layer 8 around which the filament 9 is wound by an extrusion method, a dipping method, or the like.

  Next, a hydrophilic polymer material is applied to a predetermined portion of the outer surface of the sheath tube 2 thus manufactured. Thereafter, the distal end 3 of the sheath tube 2 is tapered, and the hub 11 is attached to the proximal end 4 to manufacture the introducer sheath 1.

Second Embodiment
FIG. 3 is a longitudinal sectional view showing a sheath tube of a second embodiment of the introducer sheath of the present invention.

  Hereinafter, the second embodiment of the introducer sheath of the present invention will be described with reference to this figure. However, the difference from the first embodiment will be mainly described, and the description of the same matters will be omitted. Note that the right side in FIG. 3 will be described as “base end” and the left side as “tip”.

  The sheath tube 20 of the present embodiment is the same as that of the first embodiment except that the filament 9 is composed of two layers of an inner layer 21 and an outer layer 22.

  That is, in this embodiment, the filament 9 is formed of a resin excellent in adhesiveness between the inner layer 21 formed of a resin having a tensile elastic modulus of 500 to 20000 MPa and the material forming the adhesive layer 8 and the outer tube 10. And the outer layer 22. For this reason, in addition to the sheath tube 20 being excellent in kink resistance and crush resistance, the peeling resistance of the filament 9 with respect to the adhesive layer 8 and the outer layer tube 10 is improved.

  Examples of the material constituting the inner layer 21 include polytetrafluoroethylene, ethylene-tetrafluoroethylene copolymer, fluororesin such as polyvinylidene fluoride, polyolefin such as polyamide, polyethylene, and polypropylene, polyethylene terephthalate, polybutylene terephthalate, and the like. Examples thereof include polyester and polyphenylene sulfide.

  Examples of the material constituting the outer layer 22 include adhesive polyolefins such as polyethylene modified with maleic anhydride, acrylic acid, and epoxy groups, polyamides, and the like.

  In FIG. 3, the filament 9 has a two-layer structure of an inner layer 21 and an outer layer 22, but is not limited thereto, and may be, for example, three or more layers.

<Third Embodiment>
FIG. 4 is a longitudinal sectional view showing a sheath tube of a third embodiment of the introducer sheath of the present invention.

  Hereinafter, the third embodiment of the introducer sheath of the present invention will be described with reference to this figure. However, the difference from the first embodiment described above will be mainly described, and the description of the same matters will be omitted. Note that the right side in FIG. 3 will be described as “base end” and the left side as “tip”.

  In the sheath tube 30 of the present embodiment, a radiopaque marker 31 is provided on the distal end side of the filament 9 and a distal tip 32 that does not have the filament 9 is joined to the distal end side of the sheath tube 30. Except for this, it is the same as the first embodiment.

  That is, in the present embodiment, by providing the radiopaque marker 31 on the distal end side of the filament 9, the position of the distal end of the sheath tube 30 can be easily confirmed under fluoroscopy. Examples of the material for forming such a radiopaque marker 31 include various metal materials such as gold, platinum, tungsten and iridium, and alloys containing these metal materials.

  The shape of the radiopaque marker 31 is not limited to, for example, a band (tubular body) that covers the adhesive layer 8 as shown in FIG. 4. For example, a circular filament formed of the above-described metal material is used as the adhesive layer 8. The radiopaque marker 31 may be formed by being spirally wound around the outer surface.

  Further, as shown in FIG. 4, the outer surface of the radiopaque marker 31 is completely covered with the outer tube 10. Thereby, an unevenness | corrugation does not arise in the outer surface of the sheath tube 30. FIG.

  In the present embodiment, the distal end tip 32 that does not have the filament 9 is joined to the distal end side of the sheath tube 30, so that the distal end of the sheath tube 30 becomes flexible and the blood vessel into which the sheath tube 30 is inserted is inserted. Damage is prevented.

  The material for forming the tip 32 is not particularly limited. For example, polyolefin such as polyethylene and polypropylene, polyamide such as nylon 12, polyamide elastomer, polyurethane, polyethylene terephthalate, polyester such as polybutylene terephthalate, polyester elastomer, fluorine-based material Various resin materials such as resin, or a mixture of two or more of these resin materials may be mentioned, but in order to perform fusion with the sheath tube 30 described later, a material for forming the outer tube 10 is included. It is preferable.

  The method for joining the tip 32 to the sheath tube 30 is not particularly limited, and examples thereof include adhesion and fusion.

  The tip of the tip tip 32 is tapered. As a result, the level difference from the dilator (not shown) inserted / set in the lumen 5 is reduced, and thus the blood vessel can be easily secured with little puncture resistance when inserted into the blood vessel.

  Further, the tip tip 32 may contain particles made of a radiopaque material. By including the X-ray opaque material, the visibility of the tip 32 under X-ray fluoroscopy is improved. Examples of such radiopaque materials include bismuth oxide and barium sulfate.

  EXAMPLES Next, although an Example demonstrates this invention further more concretely, this invention is not limited to these Examples.

1. Molding of inner layer tube Using high-density polyethylene as the resin that forms the inner layer body and maleic anhydride-modified high-density polyethylene as the resin that forms the adhesive layer, both resins are co-extruded and a copper wire with an outer diameter of 2.32 mm The inner layer tube having a two-layer structure of the inner layer body and the adhesive layer was molded. The tube size was 2.45 mm × 2.38 mm × 2.32 mm (adhesive layer outer diameter × inner layer body outer diameter × inner layer body inner diameter).
2. Filament Wound A filament having an outer diameter of 0.10 mm formed of polyvinylidene fluoride was spirally wound around the outer surface of the inner layer tube at a winding pitch of 0.3 mm and a winding tension of 100 g.
3. Molding of outer layer tube First, using a biaxial kneader, nylon 12, polyamide elastomer, and fine powder of bismuth oxide were blended at a weight ratio of 5: 3: 2 and cut to prepare pellets. Next, an outer layer tube was formed by hollow extrusion molding using this pellet. The tube size was 2.97 mm × 2.85 mm (outer diameter × inner diameter).
4). Compressive fusion of outer layer tube The outer layer tube was placed on the outer side of the inner layer tube around which the filament was wound. Then, a heat shrinkable tube (material: tetrafluoroethylene-hexafluoropropylene copolymer) was placed on the outside of the outer layer tube, and this was heated and heat shrunk. After the heat-shrinkable tube cooled, the heat-shrinkable tube was removed from the outer layer tube, and the copper wire in the inner layer tube was stretched and removed to produce the sheath tube of the present invention. The tube size was 2.62 mm × 2.29 mm (outer diameter × inner diameter).

(Comparative Example 1)
A sheath tube was produced in the same procedure as in Example 1 except that the filament was not wound around the outer surface of the inner layer tube. The tube size was 2.56 mm × 2.28 mm (outer diameter × inner diameter).

(Comparative Example 2)
A sheath tube was prepared by hollow extrusion molding using an ethylene-tetrafluoroethylene copolymer containing 15% by weight of fine bismuth oxide powder. The tube size was 2.52 mm × 2.22 mm (outer diameter × inner diameter).

  Next, a tube compression test and a tube kink test (kink resistance test) were performed on the sheath tubes prepared in Example 1 and Comparative Examples 1 and 2.

1. Tube compression test The sheath tube produced in Example 1 and Comparative Examples 1 and 2 was cut to 10 mm, a pressurizer was brought into contact with the middle portion of the tube, and the pushing speed was 5 mm / min using an autograph (AGS-100D). The pressurizer was pushed in to compress the tube, and the load when pushed in by 1 mm was measured (measurement temperature: 25 ° C.). As a result, the compressive load of Comparative Example 1 was 430 gf and the compressive load of Comparative Example 2 was 530 gf, whereas the compressive load of Example 1 was 620 gf. Thereby, it was confirmed that the compression resistance (collapse resistance) of the sheath tube was remarkably improved by winding the resin filament.

2. Tube Kink Test The sheath tube produced in Example 1 and Comparative Examples 1 and 2 was wound around a cylindrical metal rod, and the minimum diameter at which the sheath kinks was measured (measurement temperature: 25 ° C.). As a result, the minimum diameter of Comparative Example 1 was 50 mm and the minimum diameter of Comparative Example 2 was 21 mm, whereas the minimum diameter of Example 1 was 14 mm. Thereby, it was confirmed that the kink resistance of the sheath tube was remarkably improved by winding the resin filament.

FIG. 1 is an overall view showing a first embodiment of the introducer sheath of the present invention. 2 is a longitudinal sectional view showing a sheath tube of the introducer sheath of FIG. FIG. 3 is a longitudinal sectional view showing a sheath tube of a second embodiment of the introducer sheath of the present invention. FIG. 4 is a longitudinal sectional view showing a sheath tube of a third embodiment of the introducer sheath of the present invention.

Explanation of symbols

1, introducer sheath 2, 20, 30 sheath tube 3 distal end 4 proximal end 5 lumen 6 inner layer tube 7 inner layer body 8 adhesive layer 9 filament 10 outer layer tube 11 hub 12 distal end portion 13 proximal end portion 14 support 15 branching portion 16 Branch pipe 17 Three-way stopcock 21 Inner layer 22 Outer layer 31 X-ray impermeable marker 32 Tip

Claims (13)

An inner tube,
A filament formed of resin wound spirally around the outer surface of the inner layer tube;
An introducer sheath comprising a sheath tube comprising an outer layer tube provided outside the filament.   The introducer sheath according to claim 1, wherein a tensile elastic modulus of the resin forming the filament is 500 to 20000 MPa.   The introducer sheath according to claim 1, wherein the resin forming the filament is any one of a fluorine-based resin, polyamide, polyolefin, polyester, and polyphenylene sulfide.   The introducer sheath according to any one of claims 1 to 3, wherein the filament has a multilayer structure.   The introducer sheath according to claim 1, wherein a reinforcing short fiber or a layered silicate is contained in the resin forming the filament.   The introducer sheath according to claim 5, wherein the short fiber is any one of carbon fiber, organic fiber, inorganic fiber, metal fiber, carbon nanotube, and carbon nanofiber.   The introducer sheath according to any one of claims 1 to 6, wherein the inner layer tube includes an inner layer main body and an adhesive layer provided outside the inner layer main body.   The introducer sheath according to claim 7, wherein the inner layer body is made of polyolefin or a fluorine-based resin.   The introducer sheath according to claim 7, wherein the adhesive layer contains at least an adhesive polyolefin.   The introducer sheath according to any one of claims 1 to 6, wherein an outer surface of the inner layer tube is chemically etched.   The introducer sheath according to any one of claims 1 to 10, wherein the outer layer tube is formed of any one of polyolefin, polyamide, polyurethane, polyester, and fluorine resin.   The introducer sheath according to any one of claims 1 to 11, wherein a distal tip is joined to a distal end side of the sheath tube. The introducer sheath according to any one of claims 1 to 12, wherein a radiopaque marker is provided on a distal end side of the filament.

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