WO2013140968A1 - Introducer sheath - Google Patents

Introducer sheath Download PDF

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Publication number
WO2013140968A1
WO2013140968A1 PCT/JP2013/055174 JP2013055174W WO2013140968A1 WO 2013140968 A1 WO2013140968 A1 WO 2013140968A1 JP 2013055174 W JP2013055174 W JP 2013055174W WO 2013140968 A1 WO2013140968 A1 WO 2013140968A1
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WO
WIPO (PCT)
Prior art keywords
sheath
introducer sheath
introducer
distal end
end portion
Prior art date
Application number
PCT/JP2013/055174
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French (fr)
Japanese (ja)
Inventor
遼 岡村
侑振 矢崎
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テルモ株式会社
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Publication of WO2013140968A1 publication Critical patent/WO2013140968A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0687—Guide tubes having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths

Definitions

  • the present invention relates to an introducer sheath.
  • a catheter In recent years, various forms of treatments and examinations have been performed in medicine using an elongated hollow tubular medical device called a catheter.
  • the following procedure using a treatment catheter is performed using the longness of the catheter. That is, a method of administering a drug directly to a diseased part using a catheter, a method of opening and opening a stenotic part in a body cavity using a catheter with a balloon that is expanded by pressurization attached to the tip, and a catheter having a cutter attached to the tip There is a method of scraping and opening the affected part by using, and conversely, a method of closing the aneurysm, bleeding site or feeding blood vessel using a catheter.
  • a treatment method in which a tubular stent having a meshed side surface is implanted into the body cavity using a catheter and placed.
  • a blood clot that occludes a blood vessel may be aspirated.
  • a catheter introducer is used to introduce an introducer sheath into the puncture site formed on the arm or leg, and the inside of the introducer sheath.
  • a catheter or the like is percutaneously inserted into a lesion such as a blood vessel through the cavity.
  • the introducer sheath is formed from a sheath tube that is a tubular member having a hollow portion through which a long body such as a catheter can be inserted (see Patent Document 1).
  • the introducer sheath includes a distal end portion that becomes the distal end side when introduced into the puncture site, and a main body portion that is located on the proximal end side of the distal end portion.
  • a conventional sheath for an introducer does not have a structure in which the tip portion is prevented from being bent and the thickness is reduced.
  • an object of the present invention is to provide a sheath for an introducer that can prevent the tip portion from being bent when introduced into a puncture site even if the wall thickness is reduced.
  • An introducer sheath which is formed of a tubular member having a hollow portion through which a long body can be inserted, and which includes a tip portion having a tapered outer diameter and a main body portion having a constant outer diameter,
  • the introducer sheath is an introducer sheath having an outer shape curved in a convex shape radially outward in a cross section parallel to the axial direction.
  • the distal end portion of the introducer sheath is curved in a convex shape radially outward in a cross section parallel to the axial direction, so that it is introduced into the puncture site even if the wall thickness is reduced. Sometimes it is possible to prevent the tip portion from curling.
  • the convex end of the introducer sheath being curved. That is, when the distal end portion of the introducer sheath is introduced into the puncture site, the stress received by the distal end portion from the puncture site can be dispersed and relaxed. Therefore, when the distal end portion of the introducer sheath is introduced into the puncture site, it is possible to prevent stress from being concentrated and drowning at, for example, the front site of the distal end portion. Furthermore, since the thickness of the introducer sheath is relatively thicker on the proximal side than the leading portion, the introducer sheath does not buckle in a bellows shape.
  • the tip of the introducer sheath is bent into a quadratic curve, the following effects are obtained. That is, when the distal end portion of the introducer sheath is introduced into the puncture site, the stress received by the distal end portion from the puncture site can be evenly dispersed and relaxed. Therefore, when the distal end portion of the introducer sheath is introduced into the puncture site, it is possible to effectively prevent stress from being concentrated and drowning at, for example, the leading site of the distal end portion. Furthermore, since the thickness of the introducer sheath is relatively thicker on the proximal side than the leading portion, the introducer sheath does not buckle in a bellows shape.
  • the tip of the introducer sheath curved in a quadratic curve is formed into a parabolic shape, the following effects can be obtained. That is, when the distal end portion of the introducer sheath is introduced into the puncture site, the stress received by the distal end portion from the puncture site can be evenly distributed and relaxed along the outer shape of the distal end portion. Therefore, when the distal end portion of the introducer sheath is introduced into the puncture site, it is possible to more effectively prevent stress from being concentrated and drowning at, for example, the leading site of the distal end portion. Furthermore, since the thickness of the introducer sheath is relatively thicker on the proximal side than the leading portion, the introducer sheath does not buckle in a bellows shape.
  • FIG. 6 is a schematic diagram showing, in order from (A) to (C), a method in which the presence or absence of occurrence of wobbling at the distal end portion of the introducer sheath is verified by inserting the introducer assembly into the puncture test film.
  • the introducer sheath 10 is an instrument for securing an access route into a body cavity.
  • the introducer sheath 10 is placed in the body cavity.
  • an imaging catheter as a diagnostic instrument, a balloon or a stent as a therapeutic instrument is inserted and introduced into a body cavity.
  • the proximal operation portion side of the introducer assembly 1 is referred to as “base end side”, and the side inserted into the body cavity is referred to as “distal end side”.
  • FIG. 1 is a plan view showing an introducer assembly 1 to which an introducer sheath 10 according to this embodiment is applied.
  • FIG. 2 is a plan view showing the introducer assembly 1 disassembled into an introducer sheath 10 and a dilator 20.
  • FIG. 3 is a perspective view showing the introducer sheath 10.
  • FIG. 4 is a perspective view showing the introducer sheath 10 in cross section.
  • FIG. 5 is a plan view showing the introducer sheath 10 in cross section.
  • the introducer assembly 1 includes an introducer sheath 10 that secures an access route into a body cavity and an introducer sheath 10 that is placed percutaneously in the body cavity. And an auxiliary dilator 20.
  • an introducer sheath 10 and the dilator 20 of the introducer assembly 1 will be described in detail.
  • the introducer sheath 10 ensures an access route into the body cavity.
  • a contrast catheter as a diagnostic instrument, a balloon or a stent as a therapeutic instrument is inserted into the body cavity, and is introduced into the body cavity.
  • Such an introducer sheath 10 includes, for example, a sheath tube 11, a sheath hub 12, a hemostasis valve 13, a side port 14, a tube 15, and a three-way stopcock 16.
  • a sheath tube 11 includes, for example, a sheath tube 11, a sheath hub 12, a hemostasis valve 13, a side port 14, a tube 15, and a three-way stopcock 16.
  • the sheath tube 11 of the introducer sheath 10 is percutaneously placed in the body cavity, and then a contrast catheter as a diagnostic instrument, a balloon or a stent as a therapeutic instrument is inserted into the body cavity and introduced into the body cavity. Is done.
  • a sheath tube 11 is formed in, for example, an elongated tubular shape, and its proximal end side is connected to the distal end side of the sheath hub 12.
  • the sheath tube 11 includes a tip portion 11a having a tapered outer diameter and a main body portion 11b having a constant outer diameter.
  • the outer shape of the distal end portion 11a of the sheath tube 11 is curved in a convex shape radially outward when viewed from a cross section parallel to the axial direction.
  • the outer shape of the tip 11a of the sheath tube 11 that is curved in a convex shape is curved in a quadratic curve as shown in FIG.
  • the outer shape of the distal end portion 11a of the sheath tube 11 curved in a quadratic curve is, for example, a parabolic shape.
  • the sheath tube 11 is made of polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyolefin elastomer, cross-linked polyolefin. Body, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin, polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide, aromatic polyetherketone and other polymer materials, or these It can be formed with a mixture or the like. Furthermore, the sheath tube 11 is preferably formed of ethylene tetrafluoroethylene copolymer (ETFE), but is not limited to the material.
  • EFE ethylene tetrafluoroethylene copolymer
  • the sheath hub 12 of the introducer sheath 10 allows the sheath tube 11 and the side port 14 to communicate with each other and incorporates a hemostasis valve 13.
  • a sheath hub 12 is formed, for example, in a rectangular shape having a cavity therein, and is connected to the proximal end side of the sheath tube 11.
  • the sheath hub 12 is provided with a kink preventing member made of, for example, a soft resin on the distal end side, and the bending of the introducer sheath 10 is buffered by the kink preventing member.
  • the sheath hub 12 is preferably formed of a hard resin such as polyolefin such as polyethylene or polypropylene, polyamide, polycarbonate, or polystyrene, except for the kink preventing member, but is not limited to the material.
  • a hard resin such as polyolefin such as polyethylene or polypropylene, polyamide, polycarbonate, or polystyrene, except for the kink preventing member, but is not limited to the material.
  • the hemostasis valve 13 of the introducer sheath 10 stops blood flowing out from the blood vessel via the sheath tube 11.
  • a hemostasis valve 13 is formed, for example, in a substantially elliptic shape, and is fixed inside the sheath hub 12 in a liquid-tight state.
  • the hemostasis valve 13 is preferably formed of elastic silicone rubber, latex rubber, butyl rubber, isoprene rubber or the like, but is not limited to the material.
  • the side port 14 of the introducer sheath 10 communicates the sheath tube 11 and the tube 15.
  • a side port 14 is formed, for example, in a cylindrical shape, and one end thereof is connected to the sheath tube 11 and the other end is connected to the tube 15 in a liquid-tight manner.
  • the tube 15 of the introducer sheath 10 communicates the side port 14 and the three-way cock 16.
  • a tube 15 is formed, for example, from a bendable cylindrical shape, one end of which is connected to the side port 14 and the other end is connected to the three-way stopcock 16 in a liquid-tight manner.
  • the tube 15 is preferably formed of, for example, flexible polybutadiene, but is not limited to a material.
  • the three-way cock 16 of the introducer sheath 10 injects a liquid such as physiological saline into the introducer sheath 10 via the tube 15 and the side port 14.
  • a tube 15 is formed in a cylindrical shape, and one end thereof is connected to the side port 14.
  • the dilator 20 assists the insertion of the introducer sheath 10 percutaneously placed in the body cavity.
  • the dilator 20 expands the skin perforation and prevents the sheath tube 11 from breaking when the sheath tube 11 of the introducer sheath 10 is inserted into the blood vessel.
  • a dilator 20 includes, for example, a dilator tube 21 and a dilator hub 22.
  • a dilator tube 21 and a dilator hub 22.
  • the dilator tube 21 of the dilator 20 is inserted into the sheath tube 11 and assists the insertion of the introducer sheath 10 percutaneously placed in the body cavity. That is, the dilator tube 21 inserted into the sheath tube 11 is in a state in which the distal end on the proximal end side protrudes from the distal end of the sheath tube 11 as shown in FIG.
  • a dilator tube 21 is formed in, for example, an elongated tubular shape, and its proximal end side is connected to the distal end side of the dilator hub 22.
  • the dilator tube 21 is made of polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyolefin elastomer, and polyolefin.
  • Cross-linked material polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin, polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide, aromatic polyetherketone, or other polymer materials or these It can be formed with a mixture or the like.
  • the dilator hub 22 of the dilator 20 holds the dilator tube 21 detachably with respect to the sheath hub 12.
  • a dilator hub 22 is formed, for example, in a cylindrical shape having a step, and is connected to the proximal end side of the dilator tube 21.
  • the sheath hub 12 is preferably formed of a polyolefin such as polyethylene or polypropylene, or a hard resin such as polyamide, polycarbonate, or polystyrene, but is not limited to the material.
  • FIG. 6 shows a method for verifying whether or not there is any occurrence of wrinkling at the distal end portion 11a of the sheath tube 11 of the introducer sheath 10 by inserting the introducer assembly into the puncture test coating 100 made of cowhide or the like ( It is a schematic diagram shown in order of A) to (C).
  • FIG. 6A shows a state immediately before the introducer assembly 1 is inserted into the puncture test coating 100.
  • the puncture needle is previously punctured at an angle of 30 degrees with respect to the puncture test film 100 and then removed, and the guide wire 30 is inserted.
  • the introducer assembly 1 is inserted along the guide wire 30 at an angle of 30 degrees with respect to the puncture test coating 100.
  • FIG. 6B corresponds to a state in which the introducer assembly 1 is being inserted into the puncture test membrane 100, and the leading portion 11 aa of the distal end portion 11 a of the sheath tube 11 contacts the puncture test membrane 100. ing.
  • the leading portion 11aa of the distal end portion 11a of the sheath tube 11 is in contact with the puncture test coating 100 and is loaded, but no sag occurs.
  • FIG. 6C corresponds to a state in which the introducer assembly 1 has been inserted into the puncture test membrane 100, and the leading portion 11aa of the distal end portion 11 a of the sheath tube 11 penetrates the puncture test membrane 100.
  • the leading portion 11aa of the distal end portion 11a of the sheath tube 11 is loaded when it penetrates through the puncture test coating 100, but no sag occurs.
  • FIG. 6C As shown in Table 1, with respect to the introducer sheath 10 according to this embodiment and the sheath in which the outer shape of the distal end portion of the sheath tube according to the comparative example is formed in a linear taper shape, FIG. The verification shown in FIG. 6C was performed seven times. In the case of the introducer sheath 10 according to the present embodiment, the bending of the distal end portion 11a of the sheath tube 11 was not visually confirmed in a total of seven verifications. On the other hand, in the case of the sheath related to the proportionality, in the total of seven verifications, except for the fifth, the tip portion of the sheath tube was confirmed visually.
  • the distal end portion 11a of the sheath tube 11 of the introducer sheath 10 is formed so as to be curved radially outward in a cross section parallel to the axial direction, thereby reducing the thickness.
  • the distal end portion 11a of the sheath tube 11 is curved in a convex shape, so that when the distal end portion 11a of the sheath tube 11 is introduced into the puncture site, the distal end portion 11a is separated from the puncture site.
  • the stress received can be dispersed and relaxed. Therefore, when the distal end portion 11a of the sheath tube 11 is introduced into the puncture site, it is possible to prevent stress from being concentrated and drowning at the leading end portion 11aa of the distal end portion 11a.
  • the thickness of the sheath tube 11 is relatively thick at the distal end portion 11a which is the proximal end side from the leading portion 11aa. Therefore, the sheath tube 11 does not buckle in a bellows shape.
  • the tip end portion 11a curved in a convex shape of the sheath tube 11 of the introducer sheath 10 can be shaped into a quadratic curve. If the shape of the distal end portion 11a of the sheath tube 11 is formed in this way, when the distal end portion 11a of the sheath tube 11 is introduced into the puncture site, the stress received by the distal end portion 11a from the puncture site is evenly dispersed and relaxed. be able to. Therefore, when the distal end portion 11a of the sheath tube 11 is introduced into the puncture site, it is possible to effectively prevent stress from being concentrated and drowning at, for example, the leading site 11aa of the distal end portion 11a. Furthermore, the thickness of the sheath tube 11 is relatively thick at the distal end portion 11a which is the proximal end side from the leading portion 11aa. Therefore, the sheath tube 11 does not buckle in a bellows shape.
  • the outer shape of the distal end portion 11a curved in a quadratic curve shape of the sheath tube 11 of the introducer sheath 10 can be formed into a parabolic curved shape. If the shape of the distal end portion 11a of the sheath tube 11 is formed in this way, when the distal end portion 11a of the sheath tube 11 is introduced into the puncture site, the stress that the distal end portion 11a receives from the puncture site is applied to the outer shape of the distal end portion 11a. Can be dispersed and relaxed evenly.
  • the distal end portion 11a of the sheath tube 11 when the distal end portion 11a of the sheath tube 11 is introduced into the puncture site, it is possible to more effectively prevent stress from being concentrated and drowning at, for example, the leading site 11aa of the distal end portion 11a. Furthermore, the thickness of the sheath tube 11 is relatively thick at the distal end portion 11a which is the proximal end side from the leading portion 11aa. Therefore, the sheath tube 11 does not buckle in a bellows shape.
  • This application is based on Japanese Patent Application No. 2012-066009 filed on March 22, 2012, the disclosure of which is incorporated by reference in its entirety.

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Abstract

[Problem] To provide an introducer sheath that is capable of preventing a tip section from curling when introduced to a puncture site, even if the wall thickness is made thin. [Solution] An introducer sheath (10) is formed from a tubular member provided with a hollow section through which an elongated body can be inserted, and is provided with a sheath tube (11) that is provided with a tip section (11a) having a tapered outer diameter, and a body section (11b) having a fixed outer diameter. The external shape of the tip section of the sheath tube is curved in a convex shape in a radially outward direction in a cross section parallel to the axial direction.

Description

イントロデューサー用シースIntroducer sheath
　本発明は、イントロデューサー用シースに関する。 The present invention relates to an introducer sheath.
　近年医療において、カテーテルと呼ばれる細長い中空管状の医療器具を用いて様々な形態の治療や検査が行われている。このような治療方法としては、カテーテルの長尺性を利用して次のような治療用カテーテルを用いた手技が行われている。すなわち、カテーテルにより直接患部に薬剤を投与する方法、加圧によって拡張するバルーンを先端に取り付けたカテーテルを用いて体腔内の狭窄部を押し広げて開く方法、先端部にカッターが取り付けられたカテーテルを用いて患部を削り取って開く方法、逆にカテーテルを用いて動脈瘤や出血箇所あるいは栄養血管に詰め物をして閉じる方法等がある。また、体腔内の狭窄部を開口した状態に維持するために、側面が網目状になっている管形状をしたステントをカテーテルを用いて体腔内に埋め込んで留置する治療方法等がある。また、血管を閉塞する血栓を吸引すること等がある。 In recent years, various forms of treatments and examinations have been performed in medicine using an elongated hollow tubular medical device called a catheter. As such a treatment method, the following procedure using a treatment catheter is performed using the longness of the catheter. That is, a method of administering a drug directly to a diseased part using a catheter, a method of opening and opening a stenotic part in a body cavity using a catheter with a balloon that is expanded by pressurization attached to the tip, and a catheter having a cutter attached to the tip There is a method of scraping and opening the affected part by using, and conversely, a method of closing the aneurysm, bleeding site or feeding blood vessel using a catheter. In addition, in order to maintain the stenosis in the body cavity in an open state, there is a treatment method in which a tubular stent having a meshed side surface is implanted into the body cavity using a catheter and placed. In addition, a blood clot that occludes a blood vessel may be aspirated.
　カテーテルを用いて治療・検査等を行う場合には、一般的に、カテーテルイントロデューサーを使用して、腕または脚に形成された穿刺部位にイントロデューサー用シースを導入し、イントロデューサー用シースの内腔を介してカテーテル等を経皮的に血管等の病変部に挿入している。 When performing treatment / inspection using a catheter, generally, a catheter introducer is used to introduce an introducer sheath into the puncture site formed on the arm or leg, and the inside of the introducer sheath. A catheter or the like is percutaneously inserted into a lesion such as a blood vessel through the cavity.
　イントロデューサー用シースは、カテーテル等の長尺体を挿通自在な中空部を備える管状部材であるシースチューブから形成されている（特許文献１を参照）。イントロデューサー用シースは、穿刺部位への導入時に先端側となる先端部と、先端部の基端側に位置する本体部とを備えている。 The introducer sheath is formed from a sheath tube that is a tubular member having a hollow portion through which a long body such as a catheter can be inserted (see Patent Document 1). The introducer sheath includes a distal end portion that becomes the distal end side when introduced into the puncture site, and a main body portion that is located on the proximal end side of the distal end portion.
特開平８－１３１５５２号公報JP-A-8-131552
　イントロデューサー用シースの外径を小さくすることにより皮膚や血管に穿刺容易としたり、イントロデューサー用シースの内径を大きくすることにより径大の長尺体を挿通可能としたりするためには、イントロデューサー用シースの肉厚を薄くすることが好ましい。 To reduce the outer diameter of the introducer sheath and make it easier to puncture skin and blood vessels, or to increase the inner diameter of the introducer sheath, it is possible to insert a large elongated body. It is preferable to reduce the thickness of the sheath for use.
　しかしながら、イントロデューサー用シースの肉厚を薄くすると、そのイントロデューサー用シースを皮膚や血管に穿刺するときに、先端部が捲れやすくなるという問題が生じる。従来のイントロデューサー用シースには、先端部の捲れを防止した上で肉厚を薄く形成した構成は見あたらない。 However, when the thickness of the introducer sheath is made thin, there is a problem that the tip portion is likely to bend when the introducer sheath is punctured into the skin or blood vessel. A conventional sheath for an introducer does not have a structure in which the tip portion is prevented from being bent and the thickness is reduced.
　そこで、本発明の目的は、肉厚を薄くしても穿刺部位に導入するときに先端部の捲れを防止することができるイントロデューサー用シースを提供することにある。 Therefore, an object of the present invention is to provide a sheath for an introducer that can prevent the tip portion from being bent when introduced into a puncture site even if the wall thickness is reduced.
　上記目的は、以下の手段により達成される。 The above objective is achieved by the following means.
　（１）長尺体を挿通自在な中空部を備える管状部材から形成され、外径が先細りしてなる先端部と一定の外径からなる本体部とを備えるイントロデューサー用シースであって、
　前記先端部は、軸方向に平行した断面において、径方向外方に凸状に湾曲した外形形状を有するイントロデューサー用シース。 (1) An introducer sheath which is formed of a tubular member having a hollow portion through which a long body can be inserted, and which includes a tip portion having a tapered outer diameter and a main body portion having a constant outer diameter,
The introducer sheath is an introducer sheath having an outer shape curved in a convex shape radially outward in a cross section parallel to the axial direction.
　（２）前記凸状に湾曲した外形形状は、二次曲線状に湾曲した外形形状である上記（１）に記載のイントロデューサー用シース。 (2) The introducer sheath according to (1), wherein the outer shape curved in a convex shape is an outer shape curved in a quadratic curve shape.
　（３）前記二次曲線状に湾曲した外形形状は、放物線状に湾曲した外形形状である上記（２）に記載のイントロデューサー用シース。 (3) The introducer sheath according to (2), wherein the outer shape curved in a quadratic curve is a parabolic curved outer shape.
　本発明によれば、イントロデューサー用シースの先端部を軸方向に平行した断面において径方向外方に凸状に湾曲させて形成することにより、肉厚を薄くしても、穿刺部位に導入するときに先端部の捲れを防止することができる。 According to the present invention, the distal end portion of the introducer sheath is curved in a convex shape radially outward in a cross section parallel to the axial direction, so that it is introduced into the puncture site even if the wall thickness is reduced. Sometimes it is possible to prevent the tip portion from curling.
　具体的には、イントロデューサー用シースの先端部が凸状に湾曲していることにより、次の効果を奏する。すなわち、イントロデューサー用シースの先端部を穿刺部位に導入するときに、先端部が穿刺部位から受ける応力を分散して緩和させることができる。したがって、イントロデューサー用シースの先端部を穿刺部位に導入するとき、その先端部のたとえば先頭部位に応力が集中して捲れてしまうことを防止できる。さらに、イントロデューサー用シースの肉厚は先頭部位より基端側において比較的太いことから、イントロデューサー用シースが蛇腹状に座屈することがない。 More specifically, the following effect is achieved by the convex end of the introducer sheath being curved. That is, when the distal end portion of the introducer sheath is introduced into the puncture site, the stress received by the distal end portion from the puncture site can be dispersed and relaxed. Therefore, when the distal end portion of the introducer sheath is introduced into the puncture site, it is possible to prevent stress from being concentrated and drowning at, for example, the front site of the distal end portion. Furthermore, since the thickness of the introducer sheath is relatively thicker on the proximal side than the leading portion, the introducer sheath does not buckle in a bellows shape.
　ここで、イントロデューサー用シースの先端部を、二次曲線状に湾曲した形状にした場合、次の効果を奏する。すなわち、イントロデューサー用シースの先端部を穿刺部位に導入するときに、先端部が穿刺部位から受ける応力を均等に分散して緩和させることができる。したがって、イントロデューサー用シースの先端部を穿刺部位に導入するとき、その先端部のたとえば先頭部位に応力が集中して捲れてしまうことを効果的に防止できる。さらに、イントロデューサー用シースの肉厚は先頭部位より基端側において比較的太いことから、イントロデューサー用シースが蛇腹状に座屈することがない。 Here, when the tip of the introducer sheath is bent into a quadratic curve, the following effects are obtained. That is, when the distal end portion of the introducer sheath is introduced into the puncture site, the stress received by the distal end portion from the puncture site can be evenly dispersed and relaxed. Therefore, when the distal end portion of the introducer sheath is introduced into the puncture site, it is possible to effectively prevent stress from being concentrated and drowning at, for example, the leading site of the distal end portion. Furthermore, since the thickness of the introducer sheath is relatively thicker on the proximal side than the leading portion, the introducer sheath does not buckle in a bellows shape.
　さらに、イントロデューサー用シースの二次曲線状に湾曲した先端部を、放物線状に湾曲した形状にした場合、次の効果を奏する。すなわち、イントロデューサー用シースの先端部を穿刺部位に導入するときに、先端部が穿刺部位から受ける応力をその先端部の外形に沿って均等に分散して緩和させることができる。したがって、イントロデューサー用シースの先端部を穿刺部位に導入するとき、その先端部のたとえば先頭部位に応力が集中して捲れてしまうことをより効果的に防止できる。さらに、イントロデューサー用シースの肉厚は先頭部位より基端側において比較的太いことから、イントロデューサー用シースが蛇腹状に座屈することがない。 Furthermore, when the tip of the introducer sheath curved in a quadratic curve is formed into a parabolic shape, the following effects can be obtained. That is, when the distal end portion of the introducer sheath is introduced into the puncture site, the stress received by the distal end portion from the puncture site can be evenly distributed and relaxed along the outer shape of the distal end portion. Therefore, when the distal end portion of the introducer sheath is introduced into the puncture site, it is possible to more effectively prevent stress from being concentrated and drowning at, for example, the leading site of the distal end portion. Furthermore, since the thickness of the introducer sheath is relatively thicker on the proximal side than the leading portion, the introducer sheath does not buckle in a bellows shape.
本実施形態に係るイントロデューサー用シースを適用したイントロデューサー組立体を示す平面図である。It is a top view which shows the introducer assembly to which the sheath for introducers which concerns on this embodiment is applied. イントロデューサー組立体をイントロデューサー用シースとダイレーターに分解して示す平面図である。It is a top view which decomposes | disassembles and shows an introducer assembly to the sheath for introducers, and a dilator. イントロデューサー用シースを示す斜視図である。It is a perspective view which shows the sheath for introducers. イントロデューサー用シースを断面で示す斜視図である。It is a perspective view which shows the sheath for introducers in a cross section. イントロデューサー用シースを断面で示す平面図である。It is a top view which shows the sheath for introducers in a cross section. イントロデューサー用シースの先端部における捲れ発生の有無を穿刺試験用皮膜にイントロデューサー組立体を挿入することにより検証した方法を（Ａ）～（Ｃ）の順で示す模式図である。FIG. 6 is a schematic diagram showing, in order from (A) to (C), a method in which the presence or absence of occurrence of wobbling at the distal end portion of the introducer sheath is verified by inserting the introducer assembly into the puncture test film.
　以下、添付した図面を参照しながら、本発明の実施形態を説明する。なお、図面の説明において同一の要素には同一の符号を付し、重複する説明を省略する。また、図面の寸法比率は、説明の都合上誇張されており、実際の比率とは異なる場合がある。 Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In the description of the drawings, the same elements are denoted by the same reference numerals, and redundant description is omitted. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may be different from the actual ratios.
　本実施形態に係るイントロデューサー用シース１０は、体腔内へのアクセスルートを確保するための器具である。このイントロデューサー用シース１０は、体腔内へ留置される。このようなイントロデューサー用シース１０の内部に、診断用器具である造影用カテーテルや治療用器具であるバルーンまたはステント等を挿通して体腔内へ導入する。なお、以下の説明において、イントロデューサー組立体１の手元操作部側を「基端側」、体腔内へ挿通される側を「先端側」と称す。 The introducer sheath 10 according to the present embodiment is an instrument for securing an access route into a body cavity. The introducer sheath 10 is placed in the body cavity. Inside the introducer sheath 10, an imaging catheter as a diagnostic instrument, a balloon or a stent as a therapeutic instrument is inserted and introduced into a body cavity. In the following description, the proximal operation portion side of the introducer assembly 1 is referred to as “base end side”, and the side inserted into the body cavity is referred to as “distal end side”.
　まず、本実施形態に係るイントロデューサー用シース１０を適用したイントロデューサー組立体１の構成について、図１～図５を参照しながら具体的に説明する。 First, the configuration of the introducer assembly 1 to which the introducer sheath 10 according to the present embodiment is applied will be specifically described with reference to FIGS. 1 to 5.
　なお、図１は、本実施形態に係るイントロデューサー用シース１０を適用したイントロデューサー組立体１を示す平面図である。また、図２は、イントロデューサー組立体１をイントロデューサー用シース１０とダイレーター２０に分解して示す平面図である。さらに、図３は、イントロデューサー用シース１０を示す斜視図である。同様に、図４は、イントロデューサー用シース１０を断面で示す斜視図である。同様に、図５は、イントロデューサー用シース１０を断面で示す平面図である。 FIG. 1 is a plan view showing an introducer assembly 1 to which an introducer sheath 10 according to this embodiment is applied. FIG. 2 is a plan view showing the introducer assembly 1 disassembled into an introducer sheath 10 and a dilator 20. FIG. 3 is a perspective view showing the introducer sheath 10. Similarly, FIG. 4 is a perspective view showing the introducer sheath 10 in cross section. Similarly, FIG. 5 is a plan view showing the introducer sheath 10 in cross section.
　イントロデューサー組立体１は、図１または図２に示すように、体腔内へのアクセスルートを確保するイントロデューサー用シース１０と、経皮的に体腔内へ留置するイントロデューサー用シース１０の挿入を補助するダイレーター２０とを有している。以下、イントロデューサー組立体１のイントロデューサー用シース１０およびダイレーター２０について詳述する。 As shown in FIG. 1 or FIG. 2, the introducer assembly 1 includes an introducer sheath 10 that secures an access route into a body cavity and an introducer sheath 10 that is placed percutaneously in the body cavity. And an auxiliary dilator 20. Hereinafter, the introducer sheath 10 and the dilator 20 of the introducer assembly 1 will be described in detail.
　イントロデューサー用シース１０は、体腔内へのアクセスルートを確保する。 The introducer sheath 10 ensures an access route into the body cavity.
　具体的には、イントロデューサー用シース１０は、体腔内へ留置された後、診断用器具である造影用カテーテルや治療用器具であるバルーンまたはステント等が内部に挿通され体腔内へ導入される。このようなイントロデューサー用シース１０は、たとえば、シースチューブ１１、シースハブ１２、止血弁１３、サイドポート１４、チューブ１５、および三方活栓１６を備えている。以下、イントロデューサー用シース１０に備えられた各構成について順に説明する。 Specifically, after the introducer sheath 10 is placed in the body cavity, a contrast catheter as a diagnostic instrument, a balloon or a stent as a therapeutic instrument is inserted into the body cavity, and is introduced into the body cavity. Such an introducer sheath 10 includes, for example, a sheath tube 11, a sheath hub 12, a hemostasis valve 13, a side port 14, a tube 15, and a three-way stopcock 16. Hereinafter, each component provided in the introducer sheath 10 will be described in order.
　イントロデューサー用シース１０のシースチューブ１１は、経皮的に体腔内へ留置された後、診断用器具である造影用カテーテルや治療用器具であるバルーンまたはステント等が内部に挿通され体腔内へ導入される。このようなシースチューブ１１は、たとえば細長い管状に形成され、その基端側がシースハブ１２の先端側に接続されている。 The sheath tube 11 of the introducer sheath 10 is percutaneously placed in the body cavity, and then a contrast catheter as a diagnostic instrument, a balloon or a stent as a therapeutic instrument is inserted into the body cavity and introduced into the body cavity. Is done. Such a sheath tube 11 is formed in, for example, an elongated tubular shape, and its proximal end side is connected to the distal end side of the sheath hub 12.
　ここで、シースチューブ１１は、図３～図５に示すように、外径が先細りした先端部１１ａと外径が一定の本体部１１ｂからなる。特に、シースチューブ１１の先端部１１ａの外形形状は、図５に示すように、軸方向に平行した断面からみた場合、径方向外方に凸状に湾曲している。さらに、シースチューブ１１の凸状に湾曲した先端部１１ａの外形形状は、図４に示すように、二次曲線状に湾曲している。また、シースチューブ１１の二次曲線状に湾曲した先端部１１ａの外形形状は、たとえば、放物線状である。 Here, as shown in FIGS. 3 to 5, the sheath tube 11 includes a tip portion 11a having a tapered outer diameter and a main body portion 11b having a constant outer diameter. In particular, as shown in FIG. 5, the outer shape of the distal end portion 11a of the sheath tube 11 is curved in a convex shape radially outward when viewed from a cross section parallel to the axial direction. Further, the outer shape of the tip 11a of the sheath tube 11 that is curved in a convex shape is curved in a quadratic curve as shown in FIG. Further, the outer shape of the distal end portion 11a of the sheath tube 11 curved in a quadratic curve is, for example, a parabolic shape.
　また、シースチューブ１１は、ポリオレフィン（たとえば、ポリエチレン、ポリプロピレン、ポリブテン、エチレン－プロピレン共重合体、エチレン－酢酸ビニル共重合体、アイオノマー、またはこれら二種以上の混合物等）、ポリオレフィンエラストマー、ポリオレフィンの架橋体、ポリ塩化ビニル、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリエステルエラストマー、ポリウレタン、ポリウレタンエラストマー、フッ素樹脂、ポリカーボネート、ポリスチレン、ポリアセタール、ポリイミド、ポリエーテルイミド、芳香族ポリエーテルケトン等の高分子材料、またはこれらの混合物等で形成することができる。さらに、シースチューブ１１は、エチレンテトラフルオロエチレン共重合体（ＥＴＦＥ）で形成することが好ましいが、材質に限定されることはない。 The sheath tube 11 is made of polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyolefin elastomer, cross-linked polyolefin. Body, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin, polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide, aromatic polyetherketone and other polymer materials, or these It can be formed with a mixture or the like. Furthermore, the sheath tube 11 is preferably formed of ethylene tetrafluoroethylene copolymer (ETFE), but is not limited to the material.
　イントロデューサー用シース１０のシースハブ１２は、シースチューブ１１とサイドポート１４とを内部で連通させ、止血弁１３を内蔵する。このようなシースハブ１２は、たとえば内部に空洞を設けた長方形状から形成され、シースチューブ１１の基端側に接続されている。ここで、シースハブ１２は、先端側にたとえば軟質樹脂からなるキンク防止部材を設け、そのキンク防止部材によりイントロデューサー用シース１０の屈曲を緩衝する。また、シースハブ１２は、キンク防止部材を除き、ポリエチレン、ポリプロピレン等のポリオレフィン、ポリアミド、ポリカーボネート、ポリスチレン等の硬質樹脂で形成することが好ましいが、材質に限定されることはない。 The sheath hub 12 of the introducer sheath 10 allows the sheath tube 11 and the side port 14 to communicate with each other and incorporates a hemostasis valve 13. Such a sheath hub 12 is formed, for example, in a rectangular shape having a cavity therein, and is connected to the proximal end side of the sheath tube 11. Here, the sheath hub 12 is provided with a kink preventing member made of, for example, a soft resin on the distal end side, and the bending of the introducer sheath 10 is buffered by the kink preventing member. The sheath hub 12 is preferably formed of a hard resin such as polyolefin such as polyethylene or polypropylene, polyamide, polycarbonate, or polystyrene, except for the kink preventing member, but is not limited to the material.
　イントロデューサー用シース１０の止血弁１３は、シースチューブ１１を介して血管内から流出する血液を止血する。このような止血弁１３は、たとえば略楕円形状から形成され、シースハブ１２の内部に液密の状態で固定されている。また、止血弁１３は、弾性を有するシリコーンゴム、ラテックスゴム、ブチルゴム、イソプレンゴム等で形成することが好ましいが、材質に限定されることはない。 The hemostasis valve 13 of the introducer sheath 10 stops blood flowing out from the blood vessel via the sheath tube 11. Such a hemostasis valve 13 is formed, for example, in a substantially elliptic shape, and is fixed inside the sheath hub 12 in a liquid-tight state. The hemostasis valve 13 is preferably formed of elastic silicone rubber, latex rubber, butyl rubber, isoprene rubber or the like, but is not limited to the material.
　イントロデューサー用シース１０のサイドポート１４は、シースチューブ１１とチューブ１５とを連通する。このようなサイドポート１４は、たとえば円筒形状から形成され、その一端がシースチューブ１１と接続され、その他端がチューブ１５と液密に接続されている。 The side port 14 of the introducer sheath 10 communicates the sheath tube 11 and the tube 15. Such a side port 14 is formed, for example, in a cylindrical shape, and one end thereof is connected to the sheath tube 11 and the other end is connected to the tube 15 in a liquid-tight manner.
　イントロデューサー用シース１０のチューブ１５は、サイドポート１４と三方活栓１６とを連通する。このようなチューブ１５は、たとえば湾曲可能な円筒形状から形成され、その一端がサイドポート１４と接続され、その他端が三方活栓１６と液密に接続されている。また、チューブ１５は、たとえば可撓性を有するポリブタジエンで形成することが好ましいが、材質に限定されることはない。 The tube 15 of the introducer sheath 10 communicates the side port 14 and the three-way cock 16. Such a tube 15 is formed, for example, from a bendable cylindrical shape, one end of which is connected to the side port 14 and the other end is connected to the three-way stopcock 16 in a liquid-tight manner. The tube 15 is preferably formed of, for example, flexible polybutadiene, but is not limited to a material.
　イントロデューサー用シース１０の三方活栓１６は、チューブ１５およびサイドポート１４を介して、イントロデューサー用シース１０に対してたとえば生理食塩水のような液体を注入する。このようなチューブ１５は、円筒形状から形成され、その一端がサイドポート１４に接続されている。 The three-way cock 16 of the introducer sheath 10 injects a liquid such as physiological saline into the introducer sheath 10 via the tube 15 and the side port 14. Such a tube 15 is formed in a cylindrical shape, and one end thereof is connected to the side port 14.
　ダイレーター２０は、経皮的に体腔内へ留置するイントロデューサー用シース１０の挿入を補助する。 The dilator 20 assists the insertion of the introducer sheath 10 percutaneously placed in the body cavity.
　具体的には、ダイレーター２０は、皮膚の穿孔を拡径し、イントロデューサー用シース１０のシースチューブ１１を血管内に挿入するときにそのシースチューブ１１が折れることを防止する。このようなダイレーター２０は、たとえば、ダイレーターチューブ２１およびダイレーターハブ２２を備えている。以下、ダイレーター２０に備えられた各構成について順に説明する。 Specifically, the dilator 20 expands the skin perforation and prevents the sheath tube 11 from breaking when the sheath tube 11 of the introducer sheath 10 is inserted into the blood vessel. Such a dilator 20 includes, for example, a dilator tube 21 and a dilator hub 22. Hereinafter, each structure with which the dilator 20 was provided is demonstrated in order.
　ダイレーター２０のダイレーターチューブ２１は、シースチューブ１１内に挿通され、経皮的に体腔内へ留置するイントロデューサー用シース１０の挿入を補助する。すなわち、シースチューブ１１内に挿通されたダイレーターチューブ２１は、図１に示すように、その基端側の先端がシースチューブ１１の先端から突出した状態となる。このようなダイレーターチューブ２１は、たとえば細長い管状に形成され、その基端側がダイレーターハブ２２の先端側に接続されている。 The dilator tube 21 of the dilator 20 is inserted into the sheath tube 11 and assists the insertion of the introducer sheath 10 percutaneously placed in the body cavity. That is, the dilator tube 21 inserted into the sheath tube 11 is in a state in which the distal end on the proximal end side protrudes from the distal end of the sheath tube 11 as shown in FIG. Such a dilator tube 21 is formed in, for example, an elongated tubular shape, and its proximal end side is connected to the distal end side of the dilator hub 22.
　また、ダイレーターチューブ２１は、ポリオレフィン（たとえば、ポリエチレン、ポリプロピレン、ポリブテン、エチレン－プロピレン共重合体、エチレン－酢酸ビニル共重合体、アイオノマー、またはこれら二種以上の混合物等）、ポリオレフィンエラストマー、ポリオレフィンの架橋体、ポリ塩化ビニル、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリエステルエラストマー、ポリウレタン、ポリウレタンエラストマー、フッ素樹脂、ポリカーボネート、ポリスチレン、ポリアセタール、ポリイミド、ポリエーテルイミド、芳香族ポリエーテルケトン等の高分子材料またはこれらの混合物等で形成することができる。 The dilator tube 21 is made of polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyolefin elastomer, and polyolefin. Cross-linked material, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin, polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide, aromatic polyetherketone, or other polymer materials or these It can be formed with a mixture or the like.
　ダイレーター２０のダイレーターハブ２２は、シースハブ１２に対してダイレーターチューブ２１を着脱自在に保持する。このようなダイレーターハブ２２は、たとえば段差を有する円柱形状から形成され、ダイレーターチューブ２１の基端側に接続されている。また、シースハブ１２は、ポリエチレン、ポリプロピレン等のポリオレフィン、ポリアミド、ポリカーボネート、ポリスチレン等の硬質樹脂で形成することが好ましいが、材質に限定されることはない。 The dilator hub 22 of the dilator 20 holds the dilator tube 21 detachably with respect to the sheath hub 12. Such a dilator hub 22 is formed, for example, in a cylindrical shape having a step, and is connected to the proximal end side of the dilator tube 21. The sheath hub 12 is preferably formed of a polyolefin such as polyethylene or polypropylene, or a hard resin such as polyamide, polycarbonate, or polystyrene, but is not limited to the material.
　次に、本実施形態に係るイントロデューサー用シース１０における捲れ発生の防止に係る検証結果について、図６および表１を参照しながら具体的に説明する。 Next, a verification result related to prevention of occurrence of sag in the introducer sheath 10 according to the present embodiment will be specifically described with reference to FIG.
　なお、図６は、イントロデューサー用シース１０のシースチューブ１１の先端部１１ａにおける捲れ発生の有無を、牛皮等からなる穿刺試験用皮膜１００にイントロデューサー組立体を挿入することにより検証した方法を（Ａ）～（Ｃ）の順で示す模式図である。 FIG. 6 shows a method for verifying whether or not there is any occurrence of wrinkling at the distal end portion 11a of the sheath tube 11 of the introducer sheath 10 by inserting the introducer assembly into the puncture test coating 100 made of cowhide or the like ( It is a schematic diagram shown in order of A) to (C).
　図６（Ａ）は、穿刺試験用皮膜１００にイントロデューサー組立体１を挿入する直前の状態を示している。ここで、図示していないが、予め、穿刺針を穿刺試験用皮膜１００に対して３０度の角度で穿刺した後に抜去し、ガイドワイヤー３０を挿入している。また、イントロデューサー組立体１は、ガイドワイヤー３０に沿わせ、穿刺試験用皮膜１００に対して３０度の角度で挿入する。 FIG. 6A shows a state immediately before the introducer assembly 1 is inserted into the puncture test coating 100. Here, although not shown, the puncture needle is previously punctured at an angle of 30 degrees with respect to the puncture test film 100 and then removed, and the guide wire 30 is inserted. The introducer assembly 1 is inserted along the guide wire 30 at an angle of 30 degrees with respect to the puncture test coating 100.
　図６（Ｂ）は、穿刺試験用皮膜１００にイントロデューサー組立体１を挿入している途中の状態に相当し、シースチューブ１１の先端部１１ａの先頭部位１１ａａが穿刺試験用皮膜１００に接触している。ここで、図６（Ｂ）に示すように、シースチューブ１１の先端部１１ａの先頭部位１１ａａは、穿刺試験用皮膜１００に接触し負荷が掛っているものの、捲れは発生していない。 FIG. 6B corresponds to a state in which the introducer assembly 1 is being inserted into the puncture test membrane 100, and the leading portion 11 aa of the distal end portion 11 a of the sheath tube 11 contacts the puncture test membrane 100. ing. Here, as shown in FIG. 6 (B), the leading portion 11aa of the distal end portion 11a of the sheath tube 11 is in contact with the puncture test coating 100 and is loaded, but no sag occurs.
　図６（Ｃ）は、穿刺試験用皮膜１００にイントロデューサー組立体１を挿入し終えた状態に相当し、シースチューブ１１の先端部１１ａの先頭部位１１ａａが穿刺試験用皮膜１００を突き抜けている。ここで、図６（Ｃ）に示すように、シースチューブ１１の先端部１１ａの先頭部位１１ａａは、穿刺試験用皮膜１００を突き抜けるときに負荷が掛ったものの、捲れは発生していない。 FIG. 6C corresponds to a state in which the introducer assembly 1 has been inserted into the puncture test membrane 100, and the leading portion 11aa of the distal end portion 11 a of the sheath tube 11 penetrates the puncture test membrane 100. Here, as shown in FIG. 6C, the leading portion 11aa of the distal end portion 11a of the sheath tube 11 is loaded when it penetrates through the puncture test coating 100, but no sag occurs.
　表１に示すように、本実施形態に係るイントロデューサー用シース１０と、対比例に係るシースチューブの先端部の外形状が直線的なテーパー状に形成されたシースについて、図６（Ａ）～図６（Ｃ）に示す検証を７回ずつ実施した。本実施形態に係るイントロデューサー用シース１０の場合、計７回の検証において、シースチューブ１１の先端部１１ａの捲れが目視で確認されなかった。一方、対比例に係るシースの場合、計７回の検証において、５回目を除き、シースチューブの先端部の捲れが目視で確認された。 As shown in Table 1, with respect to the introducer sheath 10 according to this embodiment and the sheath in which the outer shape of the distal end portion of the sheath tube according to the comparative example is formed in a linear taper shape, FIG. The verification shown in FIG. 6C was performed seven times. In the case of the introducer sheath 10 according to the present embodiment, the bending of the distal end portion 11a of the sheath tube 11 was not visually confirmed in a total of seven verifications. On the other hand, in the case of the sheath related to the proportionality, in the total of seven verifications, except for the fifth, the tip portion of the sheath tube was confirmed visually.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
　上述した本実施形態によれば、以下の効果を奏する。 According to this embodiment described above, the following effects can be obtained.
　本実施形態によれば、イントロデューサー用シース１０のシースチューブ１１の先端部１１ａを軸方向に平行した断面において径方向外方に凸状に湾曲させて形成することにより、肉厚を薄くしても、穿刺部位に導入するときに先端部の捲れを防止することができる。 According to this embodiment, the distal end portion 11a of the sheath tube 11 of the introducer sheath 10 is formed so as to be curved radially outward in a cross section parallel to the axial direction, thereby reducing the thickness. In addition, it is possible to prevent the tip portion from dripping when introduced into the puncture site.
　すなわち、本実施形態によれば、シースチューブ１１の先端部１１ａが凸状に湾曲していることにより、シースチューブ１１の先端部１１ａを穿刺部位に導入するときに、先端部１１ａが穿刺部位から受ける応力を分散して緩和させることができる。したがって、シースチューブ１１の先端部１１ａを穿刺部位に導入するとき、その先端部１１ａのたとえば先頭部位１１ａａに応力が集中して捲れてしまうことを防止できる。さらに、シースチューブ１１の肉厚は、先頭部位１１ａａより基端側である先端部１１ａにおいて比較的太い。したがって、シースチューブ１１が蛇腹状に座屈することがない。 That is, according to the present embodiment, the distal end portion 11a of the sheath tube 11 is curved in a convex shape, so that when the distal end portion 11a of the sheath tube 11 is introduced into the puncture site, the distal end portion 11a is separated from the puncture site. The stress received can be dispersed and relaxed. Therefore, when the distal end portion 11a of the sheath tube 11 is introduced into the puncture site, it is possible to prevent stress from being concentrated and drowning at the leading end portion 11aa of the distal end portion 11a. Furthermore, the thickness of the sheath tube 11 is relatively thick at the distal end portion 11a which is the proximal end side from the leading portion 11aa. Therefore, the sheath tube 11 does not buckle in a bellows shape.
　さらに、本実施形態によれば、イントロデューサー用シース１０のシースチューブ１１の凸状に湾曲した先端部１１ａを、二次曲線状に湾曲した形状にすることができる。このようにシースチューブ１１の先端部１１ａの形状を形成すれば、シースチューブ１１の先端部１１ａを穿刺部位に導入するときに、先端部１１ａが穿刺部位から受ける応力を均等に分散して緩和させることができる。したがって、シースチューブ１１の先端部１１ａを穿刺部位に導入するとき、その先端部１１ａのたとえば先頭部位１１ａａに応力が集中して捲れてしまうことを効果的に防止できる。さらに、シースチューブ１１の肉厚は、先頭部位１１ａａより基端側である先端部１１ａにおいて比較的太い。したがって、シースチューブ１１が蛇腹状に座屈することがない。 Furthermore, according to the present embodiment, the tip end portion 11a curved in a convex shape of the sheath tube 11 of the introducer sheath 10 can be shaped into a quadratic curve. If the shape of the distal end portion 11a of the sheath tube 11 is formed in this way, when the distal end portion 11a of the sheath tube 11 is introduced into the puncture site, the stress received by the distal end portion 11a from the puncture site is evenly dispersed and relaxed. be able to. Therefore, when the distal end portion 11a of the sheath tube 11 is introduced into the puncture site, it is possible to effectively prevent stress from being concentrated and drowning at, for example, the leading site 11aa of the distal end portion 11a. Furthermore, the thickness of the sheath tube 11 is relatively thick at the distal end portion 11a which is the proximal end side from the leading portion 11aa. Therefore, the sheath tube 11 does not buckle in a bellows shape.
　また、本実施形態によれば、イントロデューサー用シース１０のシースチューブ１１の二次曲線状に湾曲した先端部１１ａの外形形状を、放物線状に湾曲した形状にすることができる。このようにシースチューブ１１の先端部１１ａの形状を形成すれば、シースチューブ１１の先端部１１ａを穿刺部位に導入するときに、先端部１１ａが穿刺部位から受ける応力をその先端部１１ａの外形に沿って均等に分散して緩和させることができる。したがって、シースチューブ１１の先端部１１ａを穿刺部位に導入するとき、その先端部１１ａのたとえば先頭部位１１ａａに応力が集中して捲れてしまうことをより効果的に防止できる。さらに、シースチューブ１１の肉厚は、先頭部位１１ａａより基端側である先端部１１ａにおいて比較的太い。したがって、シースチューブ１１が蛇腹状に座屈することがない。本出願は、２０１２年３月２２日に出願された日本特許出願番号２０１２－０６６００９号に基づいており、その開示内容は、参照され、全体として、組み入れられている。 Further, according to the present embodiment, the outer shape of the distal end portion 11a curved in a quadratic curve shape of the sheath tube 11 of the introducer sheath 10 can be formed into a parabolic curved shape. If the shape of the distal end portion 11a of the sheath tube 11 is formed in this way, when the distal end portion 11a of the sheath tube 11 is introduced into the puncture site, the stress that the distal end portion 11a receives from the puncture site is applied to the outer shape of the distal end portion 11a. Can be dispersed and relaxed evenly. Therefore, when the distal end portion 11a of the sheath tube 11 is introduced into the puncture site, it is possible to more effectively prevent stress from being concentrated and drowning at, for example, the leading site 11aa of the distal end portion 11a. Furthermore, the thickness of the sheath tube 11 is relatively thick at the distal end portion 11a which is the proximal end side from the leading portion 11aa. Therefore, the sheath tube 11 does not buckle in a bellows shape. This application is based on Japanese Patent Application No. 2012-066009 filed on March 22, 2012, the disclosure of which is incorporated by reference in its entirety.
１　イントロデューサー組立体、
１０　イントロデューサー用シース、
１１　シースチューブ、
１１ａ　先端部、
１１ａａ　先頭部位、
１１ｂ　本体部、
１２　シースハブ、
１３　止血弁、
１４　サイドポート、
１５　チューブ、
１６　三方活栓、
２０　ダイレーター、
２１　ダイレーターチューブ、
２２　ダイレーターハブ。 1 Introducer assembly,
10 Introducer sheath,
11 sheath tube,
11a tip,
11aa head part,
11b body part,
12 sheath hub,
13 hemostatic valve,
14 Side port,
15 tubes,
16 Three-way stopcock,
20 Dilator,
21 Dilator tube,
22 Dilator hub.

Claims (3)

  1. 　長尺体を挿通自在な中空部を備える管状部材から形成され、外径が先細りしてなる先端部と一定の外径からなる本体部とを備えるイントロデューサー用シースであって、
    　前記先端部は、軸方向に平行した断面において、径方向外方に凸状に湾曲した外形形状を有するイントロデューサー用シース。     A sheath for an introducer that is formed from a tubular member having a hollow portion through which a long body can be inserted, and that includes a tip portion having a tapered outer diameter and a main body portion having a constant outer diameter,
    The introducer sheath is an introducer sheath having an outer shape curved in a convex shape radially outward in a cross section parallel to the axial direction.
  2. 　前記凸状に湾曲した外形形状は、二次曲線状に湾曲した外形形状である請求項１に記載のイントロデューサー用シース。 2. The introducer sheath according to claim 1, wherein the outer shape curved in a convex shape is an outer shape curved in a quadratic curve shape.
  3. 　前記二次曲線状に湾曲した外形形状は、放物線状に湾曲した外形形状である請求項２に記載のイントロデューサー用シース。 3. The introducer sheath according to claim 2, wherein the outer shape curved in a quadratic curve shape is an outer shape curved in a parabolic shape.
PCT/JP2013/055174 2012-03-22 2013-02-27 Introducer sheath WO2013140968A1 (en)

Applications Claiming Priority (2)

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JP2012-066009 2012-03-22
JP2012066009A JP2015109882A (en) 2012-03-22 2012-03-22 Sheath for introducer

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WO2013140968A1 true WO2013140968A1 (en) 2013-09-26

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107998476A (en) * 2016-10-31 2018-05-08 贝克顿·迪金森公司 Reduce the medical treatment device and transfusion device of obstruction

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001170183A (en) * 1999-12-21 2001-06-26 Top:Kk Introducer
JP3124402U (en) * 2006-05-25 2006-08-17 日本ゼオン株式会社 Dilator and sheath introducer
JP2008504936A (en) * 2004-07-02 2008-02-21 ジンテス ゲゼルシャフト ミット ベシュレンクテル ハフツング Continuous dilator system
JP2008534154A (en) * 2005-03-30 2008-08-28 アクセス サイエンティフィック、インク． Vascular access
US20100049167A1 (en) * 2008-08-20 2010-02-25 Cook Incorporated Introducer sheath having reinforced distal taper

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001170183A (en) * 1999-12-21 2001-06-26 Top:Kk Introducer
JP2008504936A (en) * 2004-07-02 2008-02-21 ジンテス ゲゼルシャフト ミット ベシュレンクテル ハフツング Continuous dilator system
JP2008534154A (en) * 2005-03-30 2008-08-28 アクセス サイエンティフィック、インク． Vascular access
JP3124402U (en) * 2006-05-25 2006-08-17 日本ゼオン株式会社 Dilator and sheath introducer
US20100049167A1 (en) * 2008-08-20 2010-02-25 Cook Incorporated Introducer sheath having reinforced distal taper

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107998476A (en) * 2016-10-31 2018-05-08 贝克顿·迪金森公司 Reduce the medical treatment device and transfusion device of obstruction

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