WO2019008922A1 - Introducteur - Google Patents

Introducteur Download PDF

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Publication number
WO2019008922A1
WO2019008922A1 PCT/JP2018/019228 JP2018019228W WO2019008922A1 WO 2019008922 A1 WO2019008922 A1 WO 2019008922A1 JP 2018019228 W JP2018019228 W JP 2018019228W WO 2019008922 A1 WO2019008922 A1 WO 2019008922A1
Authority
WO
WIPO (PCT)
Prior art keywords
sheath
introducer
tip
dilator
lubricious coating
Prior art date
Application number
PCT/JP2018/019228
Other languages
English (en)
Japanese (ja)
Inventor
毛利隆行
清水克彦
桑野陽一郎
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 WO2019008922A1 publication Critical patent/WO2019008922A1/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
    • 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

Definitions

  • the present invention relates to an introducer comprising a sheath and a dilator.
  • an introducer comprising a sheath having a lumen and a dilator to be used by being inserted into the sheath is known (see, for example, JP-A-8-171161).
  • first guide wire a thin guide wire
  • second guide wire a thick guide wire
  • radio frequency catheter ablation myocardial cautery
  • an ablation catheter is used and high frequency current is supplied to the wall of the left atrium. If an introducer is used to insert the ablation catheter into the left atrium, the introducer is first inserted into the right atrium via the blood vessel.
  • a needle called a Brockenbrough needle is protruded from the tip of the dilator, a Brockenbrough needle is pierced through a membrane called an oval fossa separating the right atrium and the left atrium, and a hole in the oval fossa
  • the introducer is advanced to penetrate the tip of the introducer into the hole formed in the fossa ovalis, and the tip is inserted into the left atrium.
  • the dilator is removed from the sheath, an ablation catheter is inserted into the sheath, and high frequency energization is performed in the left atrium.
  • the introducer disclosed in Japanese Patent Application Laid-Open No. 8-71161 has a configuration suitable for delivering, for example, a balloon catheter or the like in the blood vessel of the heart. Therefore, when using the introducer of Japanese Patent Application Laid-Open No. 8-71161 for performing the above-mentioned ablation as a treatment for atrial fibrillation, it is difficult to cause the tip of the introducer to penetrate through the hole formed in the oval fossa. Is expected. In addition, when the tip of the introducer penetrates the hole formed in the fossa ovalis, the tip of the introducer may be stuck in the wall of the left atrium with force.
  • the present invention has been made in consideration of such problems, and it is an object of the present invention to provide an introducer capable of performing insertion in the left atrium efficiently and appropriately.
  • the present invention is an introducer comprising: a sheath having a lumen; and a dilator having a lumen and used by being inserted into the lumen of the sheath, the introducer comprising: A lubricious coating is provided on the outer surface of the distal end of the sheath in a range of less than 40 mm in the proximal direction from the tip of the dilator, and in a range of 40 mm or more from the tip of the dilator. The lubricious coating is not provided.
  • the outer surface of the distal end of the sheath is provided with a lubricious coating, so that the needle protruded from the tip of the dilator for treating atrial fibrillation.
  • the tip of the introducer penetrates the hole formed in the oval fossa, the step between the dilator and the sheath is likely to pass through the hole.
  • the tip of the introducer can be easily penetrated into the hole formed in the fossa ovalis.
  • the lubricious coating is provided only in the range of less than 40 mm in the proximal direction from the leading edge of the dilator, it prevents penetration of the tip of the introducer into the wall of the left atrium during penetration of the fossa ovalis can do. Therefore, according to the present invention, it is possible to carry out the insertion of the introducer into the left atrium efficiently and appropriately.
  • the lubricious coating may be provided only in the range of 20 mm or less in the proximal direction from the tip of the sheath.
  • the lubricious coating may be provided only in the range of 10 mm or less in the proximal direction from the tip of the sheath.
  • the lubricious coating may be provided only in the range of 3.5 mm or less in the proximal direction from the tip of the sheath.
  • the lubricious coating may be provided on the distal end surface of the sheath.
  • This configuration can effectively reduce the resistance when the step between the dilator and the sheath passes through the hole formed in the fossa ovalis.
  • a coating that is less slippery than the outer circumferential surface of the sheath may be provided on the proximal end side of the outer circumferential surface of the sheath with respect to the lubricious coating.
  • the sheath may be provided with a radiopaque marker having radiopaque properties, and the distal end of the radiograph marker may be located less than 40 mm in the proximal direction from the distal end of the dilator.
  • the distal end portion of the sheath may have a tapered portion whose outer diameter decreases in the distal direction, and the lubricious coating may be provided on the outer surface of the tapered portion over the entire length of the tapered portion.
  • This configuration can effectively reduce the resistance when the tapered portion of the sheath passes through the hole formed in the fossa ovalis.
  • the distal end portion of the sheath has a tapered portion whose outer diameter decreases in the distal direction, and the tapered portion is made of a resin material containing a material having an X-ray contrast property, and the outer surface of the tapered portion
  • the lubricious coating may be provided.
  • the contrast marker can be easily provided in the tapered portion located at the distal end portion of the sheath.
  • insertion of the introducer into the left atrium can be performed efficiently and appropriately.
  • the introducer 10 according to the present embodiment shown in FIG. 1 is a medical device to be inserted into a living body (blood vessel etc.), and in particular, the tip of an ablation catheter used for radio frequency catheter ablation as a treatment for atrial fibrillation. Are delivered into the left atrium 48 (see FIG. 4 etc.).
  • the introducer 10 includes a sheath 12 having a lumen 16 a and a dilator 14 used by being inserted into the lumen 16 a of the sheath 12.
  • the sheath 12 has an elongated sheath shaft 16 constituting a sheath body, and a sheath hub 18 connected to the proximal end of the sheath shaft 16.
  • the dilator 14 has an elongated dilator shaft 20 constituting a dilator main body, and a dilator hub 22 connected to a proximal end of the dilator shaft 20.
  • a lumen 16 a is formed in the sheath shaft 16.
  • the sheath shaft 16 is flexible (flexible) so as to easily follow a tortuous blood vessel, and has an appropriate rigidity not to be bent in the blood vessel.
  • polyolefin for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of them, etc.
  • polyvinyl chloride examples thereof include polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, polymeric materials such as fluorocarbon resins, and mixtures thereof, or the above-mentioned two or more polymeric materials.
  • the sheath shaft 16 may contain a contrast agent such as a filler.
  • the sheath shaft 16 may also include a metal wire such as a stainless steel
  • the sheath hub 18 has a lumen 18a in communication with the lumen 16a formed in the sheath shaft 16, and the dilator shaft 20 can be inserted therethrough.
  • the sheath hub 18 is made of a hard material (hard resin material or the like).
  • One end of a tube 24 is connected to the sheath hub 18.
  • a stopcock 26 is provided at the other end of the tube 24.
  • a medical fluid (contrast agent, saline, medical fluid, etc.) can be supplied into the sheath hub 18 via the stopcock 26 and the tube 24 and injected into the living body via the sheath shaft 16.
  • the dilator shaft 20 is flexible (flexible) so as to easily follow a tortuous blood vessel, and has a moderate rigidity not to be bent in the blood vessel.
  • the dilator shaft 20 is a tubular member having a lumen 20a.
  • the outer diameter of the dilator shaft 20 is smaller than the outer diameter of the sheath 12.
  • the constituent material of the dilator shaft 20 may be the same as the constituent material of the sheath shaft 16.
  • the dilator hub 22 has a lumen 22 a in communication with the lumen 20 a formed in the dilator shaft 20.
  • the dilator hub 22 is attachable to and detachable from the proximal end of the sheath hub 18, and is made of a hard material (hard resin material or the like).
  • the tip of the dilator shaft 20 is The portion protrudes from the distal end opening 16 d of the sheath shaft 16 by a predetermined length.
  • the sheath 12 and the dilator 14 are thus combined (assembled state). Note that FIG. 2 shows the dilator 14 with the guide wire 28 inserted.
  • the distal end of the sheath 12 (the distal end of the sheath shaft 16) has a tapered portion 30 whose outer diameter decreases in the distal direction.
  • the sheath shaft 16 has a straight portion 29 whose outer diameter is constant in the axial direction, and a tapered portion 30 adjacent to the distal end side of the straight portion 29.
  • the sheath shaft 16 has a circular ring-shaped tip surface 16 b substantially perpendicular to the axis of the sheath 12.
  • the front end surface 16 b intersects the outer peripheral surface 30 a of the tapered portion 30.
  • the axial length L of the tapered portion 30 is set to, for example, 0.5 to 10 mm, preferably to 1 to 6 mm.
  • a lubricious coating 32 is provided on the outer surface of the distal end portion of the sheath 12 in a range of less than 40 mm in the proximal direction from the tip of the dilator 14 (the tip of the dilator shaft 20).
  • the lubricious coating 32 is not provided in the range of 40 mm or more in the proximal direction from the tip of the.
  • the lubricious coating 32 is, for example, a hydrophilic coating. Examples of the constituent material of the lubricating coating 32 include polyvinyl pyrrolidone and the like.
  • the lubricious coating 32 is provided only in the range of 20 mm or less in the proximal direction from the tip of the sheath 12 (sheath shaft 16). In the present embodiment, the lubricious coating 32 is provided only in the range of 10 mm or less in the proximal direction from the tip of the sheath 12. More specifically, the lubricious coating 32 is provided only in the range of 3.5 mm or less in the proximal direction from the tip of the sheath 12.
  • the lubricious coating 32 is provided on the outer surface of the tapered portion 30. More specifically, the lubricious coating 32 is provided on the outer peripheral surface 30 a and the distal end surface (the distal end surface 16 b of the sheath shaft 16) of the tapered portion 30. The lubricious coating 32 is provided over the entire length of the tapered portion 30. The most proximal end of the lubricious coating 32 is located at the same axial position as the most proximal end of the tapered portion 30. The lubricious coating 32 may be provided only at the tip of the tapered portion 30.
  • a contrast marker 34 having an X-ray contrast property is provided in the vicinity of the distal end portion of the sheath shaft 16.
  • the contrast marker 34 is configured in a circular ring shape.
  • As a constituent material of the contrast marker 34 for example, gold, platinum, tungsten or a mixture of these may be mentioned.
  • the distal end of the imaging marker 34 is located less than 40 mm in the proximal direction from the distal end of the dilator 14 (or less than 20 mm in the proximal direction from the distal end of the sheath 12).
  • the contrast marker 34 is embedded in the sheath shaft 16.
  • the contrast marker 34 may be exposed to the outer circumferential surface 16 c of the sheath shaft 16.
  • the contrast marker 34 is disposed proximal to the lubricious coating 32.
  • the contrast marker 34 may be disposed on the distal end side of the sheath shaft 16 on which the lubricious coating 32 is provided.
  • the contrast marker 34 may be under the lubricious coating 32.
  • the contrast marker 34 Under radioscopy, since the position of the lubricious coating 32 can be grasped by the contrast marker 34, it is possible to prevent puncture of the penetrating atrium. In addition, locating the contrast marker 34 under the lubricious coating 32 facilitates penetration.
  • the dilator shaft 20 has a straight portion 40 having a constant outer diameter in the axial direction, and a tapered portion 42 adjacent to the distal end side of the straight portion 40.
  • the introducer 10 with the dilator 14 inserted in the sheath 12 (assembled state) is inserted into the heart H as shown in FIG.
  • the introducer 10 is inserted from the femoral vein into the blood vessel of a living body by, for example, the Seldinger method, and advanced in the blood vessel along a guide wire (not shown) inserted into the blood vessel.
  • the tip of introducer 10 is placed in right atrium 46.
  • the position of the introducer 10 is adjusted such that the tip of the dilator 14 faces the vicinity of the oval fossa 50 which is a membrane separating the right atrium 46 and the left atrium 48.
  • the needle 52 (brocken blow needle) is protruded from the tip of the introducer 10, and the oval fossa 50 is punctured by the needle 52.
  • the needle 52 is inserted into the dilator 14, and the needle 52 protrudes from the tip of the dilator 14 toward the fossa ovalis 50.
  • the hole 52 a is formed in the oval fossa 50 by the needle 52.
  • the introducer 10 is advanced toward the hole 50a formed in the fossa ovalis 50, and the distal end of the introducer 10 (the distal end of the sheath 12 and the distal end of the dilator 14)
  • the holes 50a are penetrated.
  • the distal end opening 16 d of the sheath 12 is disposed in the left atrium 48.
  • the dilator 14 is removed from the sheath 12.
  • an ablation catheter (not shown) is inserted into the sheath 12 and the tip of the ablation catheter is placed in the left atrium 48.
  • high frequency current is applied to the wall of the left atrium 48 by the ablation catheter.
  • the introducer 10 according to the present embodiment has the following effects.
  • the oval fossa 50 is formed by the needle 52 which is protruded from the distal end of the dilator 14 in order to treat atrial fibrillation.
  • the tip of the introducer 10 is made to penetrate the formed hole 50a, the step S between the dilator 14 and the sheath 12 easily passes through the hole 50a. For this reason, the tip of the introducer 10 can be easily penetrated into the hole 50 a formed in the fossa ovalis 50.
  • the lubricious coating 32 is provided only in the range of less than 40 mm in the proximal direction from the leading edge of the dilator 14.
  • the inner diameter of the left atrium 48 is generally 20 to 40 mm (about 30 mm on average). Therefore, the penetration of the tip of the introducer 10 into the wall of the left atrium 48 (the wall 48 a facing the fossa ovalis 50) can be suppressed when the fossa ovalis 50 is penetrated. Therefore, the insertion of the introducer 10 into the left atrium 48 can be performed efficiently and appropriately.
  • the lubricious coating 32 is provided only in the range of 20 mm or less in the proximal direction from the tip of the sheath 12.
  • the lubricious coating 32 is provided only in the range of 10 mm or less in the proximal direction from the tip of the sheath 12.
  • the lubricious coating 32 is provided only in the range of 3.5 mm or less in the proximal direction from the tip of the sheath 12.
  • the distal end portion of the sheath 12 has a tapered portion 30 whose outer diameter decreases in the distal direction.
  • the lubricious coating 32 is provided on the outer surface of the tapered portion 30 over the entire length of the tapered portion 30.
  • the lubricious coating 32 is provided on the distal end surface 16 b (FIG. 3) of the sheath 12. This configuration can effectively reduce the resistance when the step S between the dilator 14 and the sheath 12 passes through the hole 50 a formed in the fossa ovalis 50.
  • the sheath 12 is provided with a contrast marker 34 having an X-ray contrast property.
  • the leading end of the imaging marker 34 is located less than 40 mm in the proximal direction from the leading end of the dilator 14.
  • a sheath 12a according to a first modification shown in FIG. 7 may be employed.
  • a coating 54 that is less slippery than the outer circumferential surface 16 c of the sheath shaft 16 is provided on the proximal end side of the outer circumferential surface of the sheath shaft 16 with respect to the lubricious coating 32.
  • the constituent material of the non-slip coating 54 include a urethane coat and the like.
  • a non-slippery coating 54 is provided adjacent to the proximal side of the lubricious coating 32. That is, the tip of the non-slippery coating 54 contacts the proximal end of the lubricious coating 32.
  • the sheath 12a is configured as described above, when the lubricious coating 32 passes through the hole 50a of the fossa ovalis 50 (FIG. 6), the friction between the non-slip coating 54 and the hole 50a of the fossa ovalis 50 The force encourages the introducer 10 to decelerate. Therefore, when the tip of the introducer 10 is penetrated through the hole 50a formed in the fossa ovalis 50, the tip of the introducer 10 can be more effectively suppressed from sticking to the wall 48a of the left atrium 48. .
  • a sheath 12b according to a second modification shown in FIG. 8 may be employed.
  • the sheath shaft 56 of the sheath 12b is adjacent to the distal end side of the straight portion 29 having the constant outer diameter (the same as the straight portion 29 shown in FIG. 3) and the straight portion 29 and the outer diameter decreases in the distal direction.
  • a tapered portion 58 is made of a resin material containing a material having an X-ray contrast property.
  • the material having radiopaque properties in the tapered portion 58 is, for example, metal powder (filler).
  • the tapered portion 58 itself functions as a contrast marker.
  • a lubricious coating 32 is provided on the outer surface (the outer peripheral surface 58a and the tip surface 58b) of the tapered portion 58 over the entire circumference.
  • the tapered portion 58 itself functions as a contrast marker, when the distal end portion of the introducer 10 penetrates the hole 50 a (FIG. 6) of the oval fossa 50, the tapered portion 58 is the hole 50 a of the oval fossa 50. It can be easily grasped that it passed. Further, the contrast marker can be easily provided on the tapered portion 58 located at the distal end portion of the sheath 12b.
  • a sheath 12c according to a third modification shown in FIG. 9 may be employed.
  • a contrast marker 60 having X-ray contrast property is provided on the entire outer circumference 30a of the tapered portion 30.
  • the lubricious coating 32 is provided on the outer peripheral surface of the contrast marker 60 and the tip surface of the tapered portion 30 (the tip surface 16 b of the sheath shaft 16).

Abstract

Cet introducteur (10) est pourvu : d'une gaine (12) ayant une lumière (16a); et d'un dilatateur (14) qui est utilisé inséré dans la lumière (16a) de la gaine (12). Au moins sur la surface extérieure d'une section d'extrémité distale de la gaine (12), un revêtement lubrifiant (32) est disposé sur une zone s'étendant à moins de 40 mm de la pointe du dilatateur (14) vers l'extrémité proximale. Le revêtement lubrifiant (32) n'est pas disposé sur une zone située à 40 mm ou plus loin de la pointe du dilatateur (14) vers l'extrémité proximale.
PCT/JP2018/019228 2017-07-07 2018-05-18 Introducteur WO2019008922A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2017-133240 2017-07-07
JP2017133240 2017-07-07

Publications (1)

Publication Number Publication Date
WO2019008922A1 true WO2019008922A1 (fr) 2019-01-10

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ID=64949927

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2018/019228 WO2019008922A1 (fr) 2017-07-07 2018-05-18 Introducteur

Country Status (1)

Country Link
WO (1) WO2019008922A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10967152B2 (en) 2017-03-10 2021-04-06 Abiomed, Inc. Expandable introducer sheath for medical device
US11660434B2 (en) 2020-02-03 2023-05-30 Abiomed, Inc. Expandable sheath with interlock dilator
WO2023157440A1 (fr) * 2022-02-15 2023-08-24 テルモ株式会社 Dilatateur, ensemble cathéter et procédé d'actionnement d'ensemble cathéter

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002143318A (ja) * 2000-11-14 2002-05-21 Ci Medeikku:Kk イントロデューシングカテーテルと診断治療用カテーテルとの組立体
JP2010527265A (ja) * 2007-05-17 2010-08-12 エピテック インコーポレイテッド シースイントロデューサ
WO2012172861A1 (fr) * 2011-06-15 2012-12-20 テルモ株式会社 Gaine pour introducteur et ensemble introducteur
US20140371676A1 (en) * 2013-05-08 2014-12-18 Clph, Llc Catheters and dilators for trans-septal procedures and methods for making and using them
JP2016530928A (ja) * 2013-08-07 2016-10-06 ベイリス メディカル カンパニー インコーポレイテッドＢａｙｌｉｓ Ｍｅｄｉｃａｌ Ｃｏｍｐａｎｙ Ｉｎｃ． 組織を穿刺する方法およびデバイス

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002143318A (ja) * 2000-11-14 2002-05-21 Ci Medeikku:Kk イントロデューシングカテーテルと診断治療用カテーテルとの組立体
JP2010527265A (ja) * 2007-05-17 2010-08-12 エピテック インコーポレイテッド シースイントロデューサ
WO2012172861A1 (fr) * 2011-06-15 2012-12-20 テルモ株式会社 Gaine pour introducteur et ensemble introducteur
US20140371676A1 (en) * 2013-05-08 2014-12-18 Clph, Llc Catheters and dilators for trans-septal procedures and methods for making and using them
JP2016530928A (ja) * 2013-08-07 2016-10-06 ベイリス メディカル カンパニー インコーポレイテッドＢａｙｌｉｓ Ｍｅｄｉｃａｌ Ｃｏｍｐａｎｙ Ｉｎｃ． 組織を穿刺する方法およびデバイス

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10967152B2 (en) 2017-03-10 2021-04-06 Abiomed, Inc. Expandable introducer sheath for medical device
US11697002B2 (en) 2017-03-10 2023-07-11 Abiomed, Inc. Expandable introducer sheath for medical device
US11969563B2 (en) 2017-03-10 2024-04-30 Abiomed, Inc. Expandable introducer sheath for medical device
US11660434B2 (en) 2020-02-03 2023-05-30 Abiomed, Inc. Expandable sheath with interlock dilator
US11944770B2 (en) 2020-02-03 2024-04-02 Abiomed, Inc. Expandable sheath with interlock dilator
WO2023157440A1 (fr) * 2022-02-15 2023-08-24 テルモ株式会社 Dilatateur, ensemble cathéter et procédé d'actionnement d'ensemble cathéter

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