WO2013140968A1 - Gaine d'introducteur - Google Patents

Gaine d'introducteur 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
Authority
WO
WIPO (PCT)
Prior art keywords
sheath
introducer sheath
introducer
distal end
end portion
Prior art date
Application number
PCT/JP2013/055174
Other languages
English (en)
Japanese (ja)
Inventor
遼 岡村
侑振 矢崎
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2013140968A1 publication Critical patent/WO2013140968A1/fr

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Classifications

    • 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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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Le problème décrit par la présente invention est de procurer une gaine d'introducteur apte à empêcher une section de pointe de s'enrouler lors de son introduction dans un site de ponction, même si l'épaisseur de la paroi est mince. La solution selon l'invention consiste à former une gaine d'introducteur (10) à partir d'un élément tubulaire pourvu d'une section creuse à travers laquelle un corps allongé peut être inséré. Ladite gaine est pourvue d'un tube de gaine (11), doté d'une section de pointe (11a) présentant un diamètre externe effilé et d'une section de corps (11b) présentant un diamètre externe fixe. La forme externe de la section de pointe du tube de gaine est incurvée en une forme convexe dans une direction orientée radialement vers l'extérieur, dans une section transversale parallèle à la direction de l'axe.
PCT/JP2013/055174 2012-03-22 2013-02-27 Gaine d'introducteur WO2013140968A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2012066009A JP2015109882A (ja) 2012-03-22 2012-03-22 イントロデューサー用シース
JP2012-066009 2012-03-22

Publications (1)

Publication Number Publication Date
WO2013140968A1 true WO2013140968A1 (fr) 2013-09-26

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Application Number Title Priority Date Filing Date
PCT/JP2013/055174 WO2013140968A1 (fr) 2012-03-22 2013-02-27 Gaine d'introducteur

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JP (1) JP2015109882A (fr)
WO (1) WO2013140968A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107998476A (zh) * 2016-10-31 2018-05-08 贝克顿·迪金森公司 减少了阻塞的医疗装置和输液器

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001170183A (ja) * 1999-12-21 2001-06-26 Top:Kk イントロデューサ
JP3124402U (ja) * 2006-05-25 2006-08-17 日本ゼオン株式会社 ダイレーターおよびシースイントロデューサー
JP2008504936A (ja) * 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 連続拡張器システム
JP2008534154A (ja) * 2005-03-30 2008-08-28 アクセス サイエンティフィック、インク． 血管アクセス
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 (ja) * 1999-12-21 2001-06-26 Top:Kk イントロデューサ
JP2008504936A (ja) * 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 連続拡張器システム
JP2008534154A (ja) * 2005-03-30 2008-08-28 アクセス サイエンティフィック、インク． 血管アクセス
JP3124402U (ja) * 2006-05-25 2006-08-17 日本ゼオン株式会社 ダイレーターおよびシースイントロデューサー
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 (zh) * 2016-10-31 2018-05-08 贝克顿·迪金森公司 减少了阻塞的医疗装置和输液器

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