WO2022064742A1 - Cathéter - Google Patents

Cathéter Download PDF

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Publication number
WO2022064742A1
WO2022064742A1 PCT/JP2021/012982 JP2021012982W WO2022064742A1 WO 2022064742 A1 WO2022064742 A1 WO 2022064742A1 JP 2021012982 W JP2021012982 W JP 2021012982W WO 2022064742 A1 WO2022064742 A1 WO 2022064742A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
hub
base end
peripheral surface
proximal end
Prior art date
Application number
PCT/JP2021/012982
Other languages
English (en)
Japanese (ja)
Inventor
大輔 島田
晃大 北村
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
Priority to JP2022551129A priority Critical patent/JPWO2022064742A1/ja
Publication of WO2022064742A1 publication Critical patent/WO2022064742A1/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

Definitions

  • the present invention relates to a catheter.
  • a catheter typically has a shaft with a lumen that communicates from the tip to the proximal end and a hub located at the proximal end of the shaft.
  • the hub is formed with a passage that communicates with the lumen in order to connect to a syringe or the like.
  • Patent Document 1 describes a method of forming a hub by insert molding. In insert molding, the shaft is placed in the mold together with the core metal, and the material of the hub is injected into the mold to form the hub so as to be continuous with the shaft.
  • Insert molding requires a special mold, and if an adhesive is used, protective equipment and ventilation equipment are required, which may increase the cost.
  • the present invention has been made to solve the above-mentioned problems, and an object of the present invention is to provide a catheter capable of allowing a device to smoothly pass through a lumen and effectively preventing a shaft from coming off a hub. ..
  • the catheter according to the present invention that achieves the above object has an inner layer and an outer layer, and a shaft in which a reinforcing body formed of a wire rod is embedded therein and a lumen penetrating from the tip end to the base end is formed, and the shaft.
  • a catheter having a hub attached to the proximal end of the shaft, wherein the shaft has a shaft proximal end formed by at least the outer layer on the proximal end side of the reinforcement from the most proximal end.
  • the shaft base end portion has a concave portion having a concave shape on the outer peripheral surface and extends in the circumferential direction, and the inner peripheral surface of the shaft base end portion is smoothly continuous with the inner peripheral surface of the hub.
  • the hub has a protrusion that is in close contact with the recess.
  • the inner peripheral surface of the shaft base end is smoothly continuous with the inner peripheral surface of the hub, so that the device can smoothly pass through the lumen. Further, since the protruding portion of the hub is in close contact with the recessed portion at the base end of the shaft, it is possible to effectively prevent the shaft from coming off the hub.
  • At least a part of the recessed portion is arranged on the proximal end side of the innermost proximal end of the inner layer. As a result, at least a part of the recessed portion has a simple layer structure formed only by the outer layer, so that the recessed portion can be easily formed.
  • the catheter 10 suppresses bending of the shaft 20 which is a long tube, the hub 40 fixed to the base end of the shaft 20, and the shaft 20. It is equipped with a flexible kink-resistant protector 70 for the purpose of.
  • the catheter 10 may be a guiding catheter, a contrast catheter, a microcatheter, or a balloon catheter or a diagnostic imaging catheter having a lumen for expansion, in addition to a catheter that supports a guide wire.
  • the catheter 10 may be an over-the-wire (OTW) type in which a guide wire lumen communicating from the tip of the shaft to the hub is formed, or a rapid exchange (RX) type in which a guide wire lumen is formed only in the tip of the shaft.
  • OW over-the-wire
  • RX rapid exchange
  • the guide wire lumen of an RX-type balloon catheter is formed from the tip of the shaft to an opening in the middle of the shaft in the axial direction.
  • the expansion lumen for circulating the fluid that expands the balloon of the RX-type balloon catheter is formed so as to communicate from the balloon to the hub at the base end of the catheter.
  • the shaft 20 has a lumen 21 that communicates from the tip end to the base end.
  • the shaft 20 has a shaft outer peripheral surface 22, a shaft inner peripheral surface 23, and a shaft base end surface 24.
  • the outer peripheral surface 22 of the shaft is a radial outer surface of the shaft 20 which is a tubular body, and extends from the tip end to the base end of the shaft 20.
  • the shaft outer peripheral surface 22 has a shaft base end side outer peripheral surface 25 formed from the base end of the shaft 20 to a predetermined position toward the tip end.
  • the outer peripheral surface 25 on the base end side of the shaft is surrounded by and accommodated in the hub 40.
  • the outer peripheral surface 25 on the base end side of the shaft has a substantially uniform outer diameter along the axis X of the shaft 20.
  • the shaft base end side outer peripheral surface 25 has a shaft fusion surface 26 fused to the hub 40 and a shaft separation surface 27 arranged on the tip end side of the shaft fusion surface 26 and separated from the hub 40. There is.
  • the shaft separating surface 27 is separated from the hub 40 with a gap without being fused to the hub 40.
  • the shaft inner peripheral surface 23 is a radial inner surface of the shaft 20 which is a tubular body, and extends from the tip end to the base end of the shaft 20.
  • the shaft base end surface 24 is a surface facing the base end side at the base end of the shaft 20, and is formed substantially perpendicular to the axis X of the shaft 20.
  • the shaft 20 in the present embodiment has an inner layer 28 forming the inner peripheral surface 23 of the shaft, an outer layer 29 forming the outer peripheral surface 22 of the shaft, and a reinforcing body 30 embedded in the shaft 20.
  • a multilayer resin tube having an outer layer and an inner layer that does not include the reinforcing body 30, a single-layer resin tube, or a metal hypo tube may be coated with a resin on the outside.
  • Examples of the constituent material of the outer layer 29 include polyamide resin, polyester resin, polyolefin resin, polyurethane resin, polyamide elastomer, polyester elastomer, polyurethane elastomer, or a mixture of one or more of these or a mixture having different hardness.
  • the outer layer 29 may be made by arranging materials having different hardness so as to be flexible from the base end to the tip end.
  • the constituent material of the inner layer 28 may be the same material as the constituent material of the outer layer 29 described above, or may be a material different from the constituent material of the outer layer 29.
  • the constituent material of the inner layer 28 may be a fluorine-based resin material such as polytetrafluoroethylene resin in order to improve the slidability of the inner peripheral surface of the shaft 20.
  • the reinforcing body 30 reinforces the shaft 20, and is formed by braiding a plurality of wire rods 31 into a cylindrical shape. Further, the reinforcing body 30 may be formed by spirally winding one or more wire rods 31. The material of the outer layer 29 or the inner layer 28 has entered the gaps between the plurality of wire rods 31 in the reinforcing body 30.
  • the wire rod 31 is made of a metal such as stainless steel or NiTi.
  • a shaft base end portion 60 to which the reinforcing body 30 is not provided is formed on the base end side of the reinforcing body 30 from the most base end.
  • the shaft base end portion 60 is formed by an outer layer 29.
  • the shaft base end portion 60 may have an inner layer 28 as a part on the distal end side. That is, the tip end portion of the shaft base end portion 60 is formed by the outer layer 29 and the inner layer 28, and the base end portion of the shaft base end portion 60 is formed by the outer layer 29.
  • the entire shaft base end portion 60 may be formed by the outer layer 29 without the inner layer 28 and the reinforcing body 30.
  • the shaft base end portion 60 has a concave recessed portion 61 on the outer peripheral surface.
  • the recessed portion 61 extends 360 degrees in the circumferential direction. Therefore, the outer diameter of the recessed portion 61 is smaller than the outer diameter of the portion on the distal end side and the outer diameter of the portion on the proximal end side of the recessed portion 61 of the shaft 20.
  • the length L of the shaft base end portion 60 in the axial direction is not particularly limited, but is preferably 0.1 to 5 mm, for example.
  • the depth D of the recess of the recess 61 is not particularly limited, but is preferably 0.01 to 1 mm, for example.
  • the hub 40 has a tubular accommodating portion 41 arranged on the distal end side and accommodating the proximal end portion of the shaft 20, a hub main body 42 arranged on the proximal end side of the accommodating portion 41, a wing 52, and a thread cutting protrusion 53. And an annular protrusion 54.
  • the hub 40 has a hub lumen 45 that communicates from the hub 40 tip opening 43 formed at the tip of the accommodating portion 41 to the hub base end opening 44 formed at the base end of the hub body 42.
  • the hub lumen 45 has an accommodating surface 46 which is an inner peripheral surface of the accommodating portion 41, an adjacent surface 47 facing the shaft base end surface 24, and a hub passage 48 which is an inner peripheral surface of the hub main body 42.
  • the accommodating surface 46 includes a hub fusion surface 49 that is directly fused with the shaft fusion surface 26 of the base end side outer peripheral surface 25, and a hub separation surface 50 that is radially outwardly opposed to the shaft separation surface 27.
  • the hub fusion surface 49 extends from the base end of the accommodation surface 46 toward the tip end.
  • the base end of the hub fusion surface 49 is connected to the adjacent surface 47.
  • the hub fusion surface 49 is formed with a protruding portion 57 that protrudes so as to enter the recessed portion 61 without a gap at a position corresponding to the recessed portion 61.
  • the protrusion 57 extends 360 degrees in the circumferential direction.
  • the inner diameter of the protruding portion 57 is smaller than the inner diameter of the portion on the distal end side and the inner diameter of the portion on the proximal end side of the protruding portion 57 of the hub fusion surface 49.
  • the hub 40 is firmly connected to the shaft 20 by the protruding portion 57 entering the recessed portion 61 and being fused.
  • the protruding portion 57 that enters the recessed portion 61 and comes into close contact with the recessed portion 61 can prevent the shaft 20 from being pulled out from the hub 40 toward the tip end.
  • the hub separating surface 50 extends from the tip of the hub fusion surface 49 toward the tip.
  • the gap between the hub separating surface 50 in the radial direction and the outer peripheral surface 25 on the base end side of the shaft widens toward the tip end.
  • the hub separation surface 50 that forms a gap with the outer peripheral surface 25 on the base end side of the shaft may not be provided.
  • the adjacent surface 47 is an annular surface facing the tip side, and is formed substantially perpendicular to the axis X of the shaft 20.
  • the radial outside of the adjacent surface 47 is connected to the hub fusion surface 49.
  • the radial inside of the adjacent surface 47 is connected to the tip of the hub passage 48.
  • the hub passage 48 has a tip-side hub passage 55 formed from the adjacent surface 47 in the proximal direction with a constant inner diameter, and has an inner diameter that gradually increases from the distal end-side hub passage 55 in the proximal direction and is tapered. It has a tapered portion 56 formed in a shape.
  • the hub passage 48 is formed in a tapered shape with an inner diameter that gradually increases toward the proximal end.
  • the hub passage 48 is preferably coaxial with the accommodating surface 46 and further coaxial with the lumen 21.
  • the inner diameter of the tip side hub passage 55 coincides with the inner diameter of the shaft base end portion 60.
  • the inner peripheral surface of the hub passage 55 on the distal end side is continuous from the inner peripheral surface of the shaft base end portion 60 with a constant inner diameter without a step.
  • a part of the taper portion 56 may have a luer taper portion 51 that can be connected to a syringe (not shown).
  • the guide wire or treatment catheter inserted through the hub proximal opening 44 smoothly passes through the stepless hub lumen 45 and lumen 21 and projects from the tip of the catheter 10. As a result, the guide wire and the treatment catheter 10 can easily reach the target position such as the lesion.
  • the wing 52 is formed so as to project from two facing positions on the outer peripheral surface of the hub body 42 so that the operator can easily grip and operate the hub 40.
  • the thread cutting protrusion 53 is formed on the outer peripheral surface of the hub body 42 on the base end side.
  • the thread cutting protrusion 53 can be engaged with a lock type syringe or the like.
  • the annular protrusion 54 is a protrusion formed on the outer peripheral surface of the accommodating portion 41 over 360 °.
  • the annular protrusion 54 can be fitted into a groove formed on the inner peripheral surface of the kink-resistant protector 70.
  • the constituent material of the hub 40 is not particularly limited as long as it is a thermoplastic resin capable of injection molding, but a material that easily transmits heat or electromagnetic waves is preferable, and specifically, a polyolefin resin, a polyamide resin, a polycarbonate resin, and a polyester resin. And so on.
  • a mandrel (not shown) is inserted into the lumen 21 of the shaft 20 and the hub lumen 45 of the hub 40, so that the outer peripheral surface 25 on the shaft base end side of the shaft 20 and the outer peripheral surface 25 on the shaft base end side are inserted.
  • the shaft base end surface 24 is heated.
  • the hub fusion surface 49 and the shaft fusion surface 26 are fused, and the adjacent surface 47 and the shaft base end surface 24 are fused.
  • the fused portion of the shaft 20 and the hub 40 may be mixed to form an integral structure.
  • the heating method is not particularly limited, and examples thereof include a method of irradiating an electromagnetic wave having a wavelength that passes through the hub 40 and does not pass through the shaft base end side outer peripheral surface 25 and the shaft base end surface 24 of the shaft 20. Since the outer peripheral surface 25 on the shaft base end side and the shaft base end surface 24 do not transmit electromagnetic waves, the outer peripheral surface 25 on the shaft base end side and the shaft base end surface 24 are first heated and melted. Then, the heat of the outer peripheral surface 25 on the base end side of the shaft is transferred to the accommodating portion 41 to melt the hub fusion surface 49 and the adjacent surface 47 of the accommodating portion 41.
  • Electromagnetic waves include heat, microwaves, visible light, and infrared rays.
  • Infrared rays are near-infrared rays having a wavelength of about 0.7 ⁇ m to 2.5 ⁇ m, mid-infrared rays having a wavelength of about 2.5 ⁇ m to 4 ⁇ m, or far-infrared rays having a wavelength of about 4 ⁇ m to 1000 ⁇ m, but are near-infrared rays, mid-infrared rays, or far-infrared rays. It may be used alone or in combination of two or more, and may contain visible light or microwaves.
  • the catheter 10 has an inner layer 28 and an outer layer 29, a reinforcing body 30 formed of a wire rod 31 is embedded therein, and a lumen 21 penetrating from the tip end to the base end is formed.
  • a catheter 10 having a shaft 20 and a hub 40 attached to the base end of the shaft 20, wherein the shaft 20 is formed by an outer layer 29 on the base end side of the reinforcing body 30 on the base end side.
  • the shaft base end portion 60 has a recessed portion 61 having a concave shape on the outer peripheral surface and extending in the circumferential direction, and the inner peripheral surface of the shaft base end portion 60 has a hub 40.
  • the hub 40 has a protruding portion 57 that is in close contact with the recessed portion 61, which is smoothly continuous with the inner peripheral surface of the hub 40.
  • the inner peripheral surface of the shaft base end 60 is smoothly continuous with the inner peripheral surface of the hub 40, so that the device can smoothly pass through the lumen. Further, since the protruding portion 57 of the hub 40 is in close contact with the recessed portion 61 of the shaft base end portion 60, it is possible to effectively prevent the shaft 20 from coming off the hub 40.
  • the outer diameter of the portion on the proximal end side of the shaft proximal portion 60 expands toward the proximal end side, but the inner diameter of the portion on the proximal end side of the shaft proximal portion 60 expands toward the proximal end side. do not have.
  • Such a structure cannot be formed by flaring that widens the inner and outer diameters of the tube toward one end. Further, the structure in which the outer diameter of the portion of the shaft base end portion 60 on the proximal end side expands toward the proximal end side cannot be inserted into the accommodating portion 41 of the hub 40 in close contact with the shaft proximal end portion 60 from the distal end side. Therefore, by simply inserting the shaft 20 into the hub 40, it is not possible to form a structure in which the protruding portion 57 is in close contact with the recessed portion 61 and the step on the inner peripheral surface is eliminated.
  • the mold may become complicated and the wraparound of the resin may be insufficient.
  • the mold since a thin shaft 20 having a small outer diameter is required, it is necessary to use a thin core metal, so that the problem that the core metal is also deformed tends to occur.
  • the protruding portion 57 of the hub 40 is brought into close contact with the recessed portion 61 of the outer peripheral surface of the shaft base end portion 60.
  • the recessed portion 61 is arranged on the proximal end side of the innermost layer 28.
  • the inner layer 28 may be arranged up to the most basic end.
  • the shaft 20 may be heated by high frequency induction heating which heats by using electromagnetic induction.
  • the electromagnetically induced conductor is, for example, a reinforcing body 30.

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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

La présente invention concerne un cathéter qui permet de faire passer en douceur un dispositif dans une lumière et de supprimer efficacement la séparation d'un corps d'un moyeu.　Le cathéter (10) comprend : un corps (20) qui comporte une couche interne (28) et une couche externe (29), présente, intégré à l'intérieur, un corps de renfort (30) formé par l'intermédiaire d'un fil (31), et présente, formée à l'intérieur, une lumière (21) pénétrant d'une extrémité distale à une extrémité proximale ; et un moyeu (40) fixé à l'extrémité proximale du corps (20). Le corps (20) comprend une section d'extrémité proximale de corps (60), formée au moins par l'intermédiaire de la couche externe (29), disposée davantage vers le côté d'extrémité proximale que l'extrémité la plus proximale du corps de renfort (30). La section d'extrémité proximale de corps (60) comprend, dans une surface circonférentielle externe, une section en retrait (61) ayant une forme évidée et s'étendant dans une direction circonférentielle. Une surface circonférentielle interne de la section d'extrémité proximale de corps (60) est continue de façon régulière avec une surface circonférentielle interne du moyeu (40). Le moyeu (40) comprend une section en saillie (57) qui adhère étroitement à la section en retrait (61).
PCT/JP2021/012982 2020-09-23 2021-03-26 Cathéter WO2022064742A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2022551129A JPWO2022064742A1 (fr) 2020-09-23 2021-03-26

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2020-158363 2020-09-23
JP2020158363 2020-09-23

Publications (1)

Publication Number Publication Date
WO2022064742A1 true WO2022064742A1 (fr) 2022-03-31

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ID=80845172

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2021/012982 WO2022064742A1 (fr) 2020-09-23 2021-03-26 Cathéter

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JP (1) JPWO2022064742A1 (fr)
WO (1) WO2022064742A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024024350A1 (fr) * 2022-07-28 2024-02-01 テルモ株式会社 Cathéter

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62281962A (ja) * 1986-05-29 1987-12-07 日本シヤ−ウツド株式会社 ねじ込み式カテ−テル接合アダプタ−
JP2008539962A (ja) * 2005-05-09 2008-11-20 ボストン サイエンティフィック リミテッド 医療用具
JP2017093868A (ja) * 2015-11-26 2017-06-01 テルモ株式会社 カテーテル

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62281962A (ja) * 1986-05-29 1987-12-07 日本シヤ−ウツド株式会社 ねじ込み式カテ−テル接合アダプタ−
JP2008539962A (ja) * 2005-05-09 2008-11-20 ボストン サイエンティフィック リミテッド 医療用具
JP2017093868A (ja) * 2015-11-26 2017-06-01 テルモ株式会社 カテーテル

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024024350A1 (fr) * 2022-07-28 2024-02-01 テルモ株式会社 Cathéter

Also Published As

Publication number Publication date
JPWO2022064742A1 (fr) 2022-03-31

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