WO2022014000A1 - カテーテル - Google Patents

カテーテル Download PDF

Info

Publication number
WO2022014000A1
WO2022014000A1 PCT/JP2020/027625 JP2020027625W WO2022014000A1 WO 2022014000 A1 WO2022014000 A1 WO 2022014000A1 JP 2020027625 W JP2020027625 W JP 2020027625W WO 2022014000 A1 WO2022014000 A1 WO 2022014000A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
catheter
slit portion
slit
tip
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2020/027625
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
武治 桂田
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Asahi Intecc Co Ltd
Original Assignee
Asahi Intecc Co Ltd
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 Asahi Intecc Co Ltd filed Critical Asahi Intecc Co Ltd
Priority to CN202080103048.9A priority Critical patent/CN115803077A/zh
Priority to EP20945024.6A priority patent/EP4183438A4/en
Priority to JP2022536062A priority patent/JP7467637B2/ja
Priority to PCT/JP2020/027625 priority patent/WO2022014000A1/ja
Publication of WO2022014000A1 publication Critical patent/WO2022014000A1/ja
Priority to US18/086,644 priority patent/US20230129088A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Images

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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0052—Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0059—Catheters; Hollow probes characterised by structural features having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0051—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids made from fenestrated or weakened tubing layer
    • 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
    • A61M25/10—Balloon catheters

Definitions

  • This disclosure relates to catheters.
  • a catheter or the like When treating a part in the body cavity such as a blood vessel, a catheter or the like is used.
  • catheters for example, a metal hypotube, a resin outer tube provided on the tip side (balloon side) of the hypotube, and a hypotube and an outer tube are provided.
  • the core wire is provided (see, for example, Patent Document 1).
  • Another such catheter includes, for example, a metal hypotube, a spiral notch on the tip side (balloon side) of the hypotube, and a resin outer tube covering the hypotube. (See, for example, Patent Document 2).
  • the core wire is provided as a rigid reinforcing material, but since it is fixed to a part of the inner peripheral surface of the hypotube in the circumferential direction, the directionality appears when the hypotube and the outer tube are curved. , The operability is not good.
  • An object of the present disclosure is to provide a catheter that can be prevented from being directional when curved and has improved operability.
  • Some aspects of this disclosure include (1) Hollow shaft and With an outer shaft arranged on the outer periphery of the hollow shaft,
  • the hollow shaft has a slit portion in which a plurality of spirally extending slits are formed.
  • the proximal end of each slit is formed at the same position in the axial direction and at equal intervals in the circumferential direction.
  • the hollow shaft is a catheter that communicates with the balloon.
  • the present disclosure can prevent the directionality from appearing at the time of bending, and can provide a catheter with improved operability.
  • the catheter includes a hollow shaft and an outer shaft arranged on the outer periphery of the hollow shaft, and the hollow shaft has a slit portion in which a plurality of spirally extending slits are formed, and the slit portion has a slit portion. , The base ends of each slit are formed at the same position in the axial direction and at equal intervals in the circumferential direction.
  • the catheter according to this embodiment will be described with reference to the drawings.
  • the present disclosure is not limited to the embodiments described in the drawings.
  • the catheter being a balloon catheter will be illustrated and described. It should be noted that the dimensions of the catheter shown in the drawings are the dimensions shown for facilitating the understanding of the contents of the implementation, and do not correspond to the actual dimensions.
  • the "tip side (distal side)” refers to the side where the tip tip is located in the long axis direction of the catheter.
  • Proximal end side (proximal side) refers to the side opposite to the tip end side in the long axis direction.
  • the “tip” refers to the distal end of each member constituting the catheter, and the “base” refers to the proximal end of each member constituting the catheter.
  • FIG. 1 is a schematic vertical sectional view of the catheter 1 according to the present embodiment.
  • the catheter 1 is roughly composed of an inner shaft 11, a tip tip 21, a balloon 31, an outer shaft 41, a hollow shaft 51, and a connector 61.
  • the inner shaft 11 is a cylindrical (hollow shape) shaft.
  • the inner shaft 11 has a lumen 11a penetrating along the major axis direction.
  • the tip of the inner shaft 11 can be connected to, for example, the tip tip 21 described later.
  • the base end portion of the inner shaft 11 is connected to, for example, the second outer shaft portion 43 of the outer shaft 41 described later, and can be arranged so that the opening 11b at the base end of the lumen 11a faces the outside.
  • Two annular markers 12 are attached to the outer periphery of the portion of the inner shaft 11 covered by the balloon 31, which will be described later.
  • the marker 12 is made of a radiation opaque material.
  • the tip tip 21 is a cylindrical (hollow shape) member connected to the tip of the inner shaft 11.
  • the tip tip 21 has a lumen 21a penetrating along the major axis direction, and the tip portion is formed so as to have a substantially sharp shape toward the tip side.
  • the above-mentioned lumen 11a and the lumen 21a communicate with each other, and the lumen L1 is formed by these.
  • a medical device such as a guide wire or a treatment device is inserted into the lumen L1.
  • the balloon 31 is a expandable / contractible member arranged so as to cover at least a part of the outer circumference of the inner shaft 11.
  • the tip of the balloon 31 is joined to the tip of the inner shaft 11 and / or the base end of the tip tip 21, and the base end is joined to the tip of the outer shaft 41 described later.
  • the balloon 31 is inflated by injecting a liquid into it, and can, for example, expand the inner wall of a blood vessel or expand a stent.
  • the outer shaft 41 is a cylindrical (hollow shape) shaft arranged so as to cover the base end side portion of the inner shaft 11 and the slit portion 52 of the hollow shaft 51 described later. Inside the outer shaft 41, a lumen 41a extending along the long axis direction is formed between the inner shaft 11 and the slit portion 52. The tip of the outer shaft 41 is joined to the base end of the balloon 31.
  • the outer shaft 41 is configured in the order of the first outer shaft portion 42 and the second outer shaft portion 43 from the tip end side.
  • the first outer shaft portion 42 and the second outer shaft portion 43 may be integrated or may be joined separately.
  • the tip of the first outer shaft portion 42 is joined to the base end of the balloon 31.
  • the inner shaft 11 is inserted inside the first outer shaft portion 42.
  • the second outer shaft portion 43 is located on the base end side of the first outer shaft portion 42.
  • the tip of the second outer shaft portion 43 is joined to the base end of the first outer shaft portion 42.
  • the base end of the second outer shaft portion 43 is joined to the tip of the shaft main body portion 53 of the hollow shaft 51 described later.
  • a base end portion of the inner shaft 11 and a slit portion 52 are inserted inside the second outer shaft portion 43.
  • the materials constituting the inner shaft 11, the tip tip 21, the balloon 31, and the outer shaft 41 described above have antithrombotic properties, flexibility, and biocompatibility because they are inserted into the body cavity. Is preferable.
  • resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, polyester elastomer, polyurethane, polyurethane elastomer, silicone, and fluororesin can be adopted.
  • FIG. 2 is an enlarged cross-sectional view of the vicinity of the slit portion 52.
  • FIG. 3 is an end view of the slit portion 52 on the base end side.
  • the hollow shaft 51 is a cylindrical (hollow shape) shaft.
  • the hollow shaft 51 has a lumen 51a penetrating along the major axis direction.
  • the hollow shaft 51 has a slit portion 52 and a shaft main body portion 53.
  • the slit portion 52 functions as a reinforcing body that reinforces the rigidity of the second outer shaft portion 43.
  • the slit portion 52 is located in the second outer shaft portion 43.
  • the slit portion 52 is composed of a hollow rope body formed by twisting a plurality of (four in this embodiment) flat plate-shaped strands, and has a lumen 52a penetrating along the long axis direction. ing.
  • the radial thickness of the hollow shaft 51 in the slit portion 52 is configured to gradually decrease from the proximal end toward the distal end. That is, each strand is configured so that its thickness gradually decreases from the base end to the tip end.
  • the slit portion 52 has a tapered shape that tapers from the proximal end side toward the distal end side.
  • the inner diameter of the slit portion 52 is configured to be substantially constant in the long axis direction.
  • the width of each strand is substantially constant from the base end to the tip end.
  • a plurality of spirally extending slits 52b are formed in the slit portion 52. That is, in the slit portion 52, a plurality of strands are twisted together so as to have a gap between adjacent strands. The width of each slit 52b is wider at the tip than at the proximal end. As shown in FIG. 3, which is an end view of the base end side of the slit portion 52, in the slit portion 52, the base ends of the slits 52b are formed at the same position in the axial direction and at equal intervals in the circumferential direction.
  • the lumen 52a of the slit portion 52 communicates with the lumen 41a of the outer shaft 41 via the tip opening of the slit portion 52 and the slit 52b.
  • the shaft main body 53 is located on the base end side of the slit 52.
  • the shaft main body 53 has a lumen 53a penetrating along the major axis direction.
  • the above-mentioned lumen 52a and the lumen 53a communicate with each other, and the lumen 52a and the lumen 53a form the lumen 51a of the hollow shaft 51.
  • the lumen 41a of the outer shaft 41 and the lumen 51a of the hollow shaft 51 communicate with each other, thereby forming an extended lumen L2.
  • the lumen 51a of the hollow shaft 51 communicates with the balloon 31 via the lumen 41a of the outer shaft 41.
  • the tip of the shaft main body 53 is joined to the base end of the slit 52 by, for example, laser welding or brazing (joining portion 53b).
  • the inner diameter of the shaft main body 53 is larger than the inner diameter of the slit 52. As a result, a step 53c is formed at the connection portion between the slit portion 52 and the shaft main body portion 53.
  • the shaft body 53 corresponds to a tubular body.
  • the material constituting the hollow shaft 51 is not particularly limited, but a superelastic alloy such as stainless steel (SUS304) or Ni—Ti alloy can be used.
  • the slit portion 52 and the shaft main body portion 53 may be made of the same material or may be made of different materials.
  • the connector 61 is a member for the operator to grip the catheter 1, and is connected to the base end of the shaft main body 53.
  • An deflator (not shown) is attached to the connector 61.
  • a liquid such as a contrast medium or a physiological saline solution is supplied from an indeflator (not shown) to the lumen 51a of the hollow shaft 51 via the connector 61.
  • the catheter 1 is a balloon catheter, and a procedure for dilating a stenosis (treatment site) existing in the coronary artery of the heart using the catheter 1 will be described.
  • a guide wire (not shown) is inserted into the blood vessel and pushed along the blood vessel to the treatment site.
  • the base end of the guide wire is inserted into the opening 21b of the lumen L1 of the balloon catheter 1 and the balloon catheter 1 is inserted into the blood vessel from the tip thereof.
  • a liquid such as a contrast medium or a physiological saline solution is supplied to the expanded lumen L2 from an indeflator (not shown) via a connector 61.
  • the liquid is not only the flow F1 flowing through the lumen 52a of the slit portion 52 which is the main path, but also a part of the liquid is passed through the slit 52b as shown by the flow F2. It flows into the lumen 41a between the slit portion 52 and the second outer shaft portion 43. As a result, the indeflation time can be shortened.
  • the liquid supplied to the expansion lumen L2 flows into the balloon 31 and expands the balloon 31.
  • the constricted portion is expanded by expanding the expanded balloon 31 while contacting the outer peripheral surface of the expanded balloon 31 with the inner wall of the constricted portion.
  • the dilated solution is discharged from the balloon 31 via the dilated lumen L2 to reduce the diameter.
  • the balloon catheter 1 is retracted and removed from the body to complete the use of the balloon catheter 1.
  • a plurality of spirally extending slits 52b are formed in the slit portion 52 of the hollow shaft 51, and in the slit portion 52, the base end of each slit 52b is in the axial direction. It is formed at the same position and at equal intervals in the circumferential direction.
  • the radial thickness of the hollow shaft 51 in the slit portion 52 is configured to gradually decrease from the base end toward the tip end.
  • the slit portion 52 can increase the flexibility from the base end side to the tip end side of the slit portion 52 while reinforcing the rigidity of the second outer shaft portion 43.
  • the outer diameter of the slit portion 52 is gradually reduced, and the outer circumference of the slit portion 52 and the inner circumference of the second outer shaft portion 43 are gradually reduced.
  • the outer shaft 41 can be reduced in diameter toward the tip by being configured so that the distance between the outer shaft and the shaft is constant.
  • the slit portion 52 is composed of a hollow rope body and is connected to a shaft main body portion 53 arranged on the base end side of the slit portion 52. Therefore, the slit portion 52 can be easily provided.
  • each slit 52b is configured so that the tip is wider than the base end.
  • the slit portion 52 can increase the flexibility from the base end side to the tip end side of the slit portion 52 while reinforcing the rigidity of the second outer shaft portion 43. Since a liquid such as a contrast medium easily passes through the slit 52b on the tip end side of the slit portion 52, it is possible to prevent a large pressure from being applied to the tip portion of the slit portion 52 having a thin thickness by the liquid such as the contrast medium. Can be done.
  • each slit 52b of the slit portion 52 may be formed in a cylindrical body by laser processing or the like.
  • the slit portion 52 which is a hollow rope body, is composed of four strands, but any number may be used as long as it is two or more.
  • the inner diameter of the slit portion 52 was substantially constant in the long axis direction, but may be gradually reduced in the long axis direction.
  • the width of each strand of the slit portion 52 was substantially constant from the base end to the tip end, but it may be configured to taper.
  • the catheter 1 was a balloon catheter, but it may be another catheter.

Landscapes

  • 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)
PCT/JP2020/027625 2020-07-16 2020-07-16 カテーテル Ceased WO2022014000A1 (ja)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CN202080103048.9A CN115803077A (zh) 2020-07-16 2020-07-16 导管
EP20945024.6A EP4183438A4 (en) 2020-07-16 2020-07-16 CATHETER
JP2022536062A JP7467637B2 (ja) 2020-07-16 2020-07-16 カテーテル
PCT/JP2020/027625 WO2022014000A1 (ja) 2020-07-16 2020-07-16 カテーテル
US18/086,644 US20230129088A1 (en) 2020-07-16 2022-12-22 Catheter

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2020/027625 WO2022014000A1 (ja) 2020-07-16 2020-07-16 カテーテル

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US18/086,644 Continuation US20230129088A1 (en) 2020-07-16 2022-12-22 Catheter

Publications (1)

Publication Number Publication Date
WO2022014000A1 true WO2022014000A1 (ja) 2022-01-20

Family

ID=79554559

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2020/027625 Ceased WO2022014000A1 (ja) 2020-07-16 2020-07-16 カテーテル

Country Status (5)

Country Link
US (1) US20230129088A1 (https=)
EP (1) EP4183438A4 (https=)
JP (1) JP7467637B2 (https=)
CN (1) CN115803077A (https=)
WO (1) WO2022014000A1 (https=)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001149482A (ja) * 1999-11-26 2001-06-05 Terumo Corp カテーテル
JP2002204831A (ja) * 1993-01-26 2002-07-23 Terumo Corp 血管拡張器具およびカテーテル
JP2002253678A (ja) 2001-03-02 2002-09-10 Kanegafuchi Chem Ind Co Ltd 医療用バルーンカテーテル
JP2007089724A (ja) * 2005-09-28 2007-04-12 Nipro Corp カテーテル
JP2007530161A (ja) * 2004-03-25 2007-11-01 メドトロニック ヴァスキュラー インコーポレイテッド カテーテルのための遷移部
JP2010527258A (ja) * 2007-05-15 2010-08-12 クック・インコーポレイテッド ハイポチューブカテーテル
JP2012152353A (ja) * 2011-01-25 2012-08-16 Asahi Intecc Co Ltd バルーンカテーテル
JP2013111264A (ja) 2011-11-29 2013-06-10 Japan Lifeline Co Ltd バルーンカテーテル

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3345147B2 (ja) * 1993-01-26 2002-11-18 テルモ株式会社 血管拡張器具およびカテーテル
JP4704581B2 (ja) * 2001-02-22 2011-06-15 テルモ株式会社 バルーンカテーテルおよびバルーンカテーテルの製造方法
JP2002355313A (ja) * 2001-03-29 2002-12-10 Nippon Zeon Co Ltd カテーテルチューブおよびバルーンカテーテル
CN105142709B (zh) * 2013-04-26 2018-04-03 泰尔茂株式会社 医疗用长尺寸件
WO2018180209A1 (ja) * 2017-03-28 2018-10-04 テルモ株式会社 医療用デバイス

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002204831A (ja) * 1993-01-26 2002-07-23 Terumo Corp 血管拡張器具およびカテーテル
JP2001149482A (ja) * 1999-11-26 2001-06-05 Terumo Corp カテーテル
JP2002253678A (ja) 2001-03-02 2002-09-10 Kanegafuchi Chem Ind Co Ltd 医療用バルーンカテーテル
JP2007530161A (ja) * 2004-03-25 2007-11-01 メドトロニック ヴァスキュラー インコーポレイテッド カテーテルのための遷移部
JP2007089724A (ja) * 2005-09-28 2007-04-12 Nipro Corp カテーテル
JP2010527258A (ja) * 2007-05-15 2010-08-12 クック・インコーポレイテッド ハイポチューブカテーテル
JP2012152353A (ja) * 2011-01-25 2012-08-16 Asahi Intecc Co Ltd バルーンカテーテル
JP2013111264A (ja) 2011-11-29 2013-06-10 Japan Lifeline Co Ltd バルーンカテーテル

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4183438A4

Also Published As

Publication number Publication date
JPWO2022014000A1 (https=) 2022-01-20
EP4183438A1 (en) 2023-05-24
US20230129088A1 (en) 2023-04-27
JP7467637B2 (ja) 2024-04-15
CN115803077A (zh) 2023-03-14
EP4183438A4 (en) 2024-05-08

Similar Documents

Publication Publication Date Title
JP4443278B2 (ja) 拡張体付カテーテル
CN108697879B (zh) 医疗用长条体
CN105963848B (zh) 球囊导管
JPWO2020012850A1 (ja) バルーンカテーテル
US10888341B2 (en) Balloon catheter
EP3130372A1 (en) Catheter and balloon catheter
US20220088354A1 (en) Balloon catheter
JP5154188B2 (ja) バルーンカテーテル
EP2399642A1 (en) Balloon catheter
JPWO2014162398A1 (ja) 生体留置物デリバリーシステム
JP6799901B2 (ja) カテーテル
WO2020153321A1 (ja) サポートカテーテル
JP2018161415A (ja) 医療用長尺体
WO2019198210A1 (ja) カテーテル
JP2025019272A (ja) サポートカテーテルおよびチューブ
JP7467637B2 (ja) カテーテル
WO2020250934A1 (ja) カテーテル
JP2015154887A (ja) ステントデリバリーシステム
JP7060454B2 (ja) 医療用チューブ
JP6882482B2 (ja) バルーンカテーテル
CN223068918U (zh) 一种球囊扩张导管
JP2024013595A (ja) バルーンカテーテル
WO2017159039A1 (ja) ステント
JP2011056148A (ja) バルーンカテーテル
JP6283221B2 (ja) 造影用マーカ及びカテーテル

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20945024

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2022536062

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2020945024

Country of ref document: EP

Effective date: 20230216