WO2021064955A1 - Corps tubulaire médical - Google Patents

Corps tubulaire médical Download PDF

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Publication number
WO2021064955A1
WO2021064955A1 PCT/JP2019/039178 JP2019039178W WO2021064955A1 WO 2021064955 A1 WO2021064955 A1 WO 2021064955A1 JP 2019039178 W JP2019039178 W JP 2019039178W WO 2021064955 A1 WO2021064955 A1 WO 2021064955A1
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WO
WIPO (PCT)
Prior art keywords
tubular body
peripheral layer
tip
coil body
medical tubular
Prior art date
Application number
PCT/JP2019/039178
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English (en)
Japanese (ja)
Inventor
友希弘 伏屋
麻里奈 北井
Original Assignee
朝日インテック株式会社
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 朝日インテック株式会社 filed Critical 朝日インテック株式会社
Priority to JP2021550894A priority Critical patent/JP7339355B2/ja
Priority to PCT/JP2019/039178 priority patent/WO2021064955A1/fr
Publication of WO2021064955A1 publication Critical patent/WO2021064955A1/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 medical tubular body.
  • a catheter inserted into a body cavity such as a blood vessel has a flexible tip extended at the tip of an inner tube in order to reduce damage to a delicate inner wall (see, for example, Patent Document 1).
  • the tip of the inner tube and the base end of the tip are simply abutted and joined. Therefore, the joint strength between the inner tube and the tip tends to be poor, and the tip may come off from the inner tube when the catheter is inserted into the body cavity.
  • the present invention has been made based on the above circumstances, and an object of the present invention is for medical use capable of suppressing damage to an object to be contacted and preventing the tip portion from coming off the hollow shaft.
  • an object of the present invention is for medical use capable of suppressing damage to an object to be contacted and preventing the tip portion from coming off the hollow shaft.
  • a first coil body formed by winding a wire and It has a first portion that covers the outer periphery of the tip end portion of the first coil body, and a second portion that extends from the tip end of the first coil body toward the tip end side and is continuous with the first portion.
  • Tubular body and With The first portion has an inner peripheral layer including the inner peripheral surface of the first portion, and an outer peripheral layer arranged radially outside the inner peripheral layer and including the outer peripheral surface of the first portion.
  • the medical tubular body according to (1) wherein a part of the first portion is sandwiched in a gap between adjacent strands on the outer peripheral surface of the tip end portion of the first coil body.
  • a second coil body arranged on the outer side in the radial direction of the first coil body and formed by winding a wire is provided.
  • the medical tubular body according to (3) above which has a tapered portion whose outer diameter is smaller than the outer diameter of the base end.
  • the "tip side” means a direction along the long axis direction, in which the second part is located with respect to the first part of the tubular body.
  • the “base end side” is a direction along the long axis direction and means a direction opposite to the tip end side.
  • the “major axis direction” means a direction along the longitudinal direction of the medical tubular body.
  • the “tip” refers to the end portion on the distal end side of any member or portion, and the “base end” indicates the end portion on the proximal end side of any member or portion.
  • the “tip portion” refers to a portion of any member or portion that includes the tip and extends halfway from the tip toward the proximal end side.
  • “Hardness” refers to “hardness” measured in accordance with the "plastic durometer hardness test method” specified in JIS K7215 (1986).
  • the present invention can provide a medical tubular body capable of suppressing damage to an object to be contacted and preventing the tip portion from coming off the hollow shaft.
  • the medical tubular body is formed from a first coil body formed by winding a wire, a first portion covering the outer circumference of the tip portion of the first coil body, and the tip of the first coil body.
  • a tubular body having a second portion extending toward the distal end side and continuous with the first portion is provided, and the first portion includes an inner peripheral layer including an inner peripheral surface of the first portion.
  • the inner peripheral layer is arranged radially outside the inner peripheral layer and includes the outer peripheral surface of the first portion, and the hardness of the inner peripheral layer is larger than the hardness of the outer peripheral layer.
  • the "radial outer side” means a direction orthogonal to the long axis direction and separated from the central axis in the longitudinal direction of the medical tubular body.
  • the first portion and the second portion are collectively referred to as a "tip tip portion”
  • the first coil body and the third portion are collectively referred to as a "hollow shaft”.
  • FIG. 1 is a schematic vertical sectional view showing a first embodiment of the present invention.
  • the medical tubular body 1 is roughly composed of a first coil body 11, a tubular body 21, and a connector 31.
  • the first coil body 11 is a spiral member formed by winding a wire 11a.
  • the first coil body 11 can be formed by, for example, using one or a plurality of strands 11a and winding adjacent strands 11a along the major axis direction.
  • the first coil body 11 may be either a single-row coil body or a multi-row coil body.
  • the strand 11a may be a single wire or a stranded wire.
  • the single wire means one single wire
  • the stranded wire means a bundle of wires formed by twisting a plurality of single wires in advance.
  • the material of the wire 11a constituting the first coil body 11 has antithrombotic property, flexibility and biocompatibility because the medical tubular body 1 is inserted into the body cavity. Is preferable.
  • a material include metal materials such as stainless steel and superelastic alloys (nickel-titanium alloys); resin materials such as polyamide resins and fluororesins.
  • the tubular body 21 can be composed of, for example, a first part 21A, a second part 21B, and a third part 21C.
  • the first portion 21A is a portion that covers the outer periphery of the tip end portion of the first coil body 11.
  • the first portion 21A includes an inner peripheral layer 21Aa including the inner peripheral surface of the first portion 21A and an outer peripheral layer 21Ab arranged radially outside the inner peripheral layer 21Aa and including the outer peripheral surface of the first portion 21A. Have.
  • the first portion 21A is formed so that the hardness of the inner peripheral layer 21Aa is larger than the hardness of the outer peripheral layer 21Ab.
  • the hardness of the inner peripheral surface of the first portion 21A measured using a needle of a durometer is the hardness of the outer peripheral surface of the first portion 21A. It can be configured to be larger (harder) than the hardness.
  • the first portion 21A may be composed of only two layers, an inner peripheral layer 21Aa and an outer peripheral layer 21Ab having a uniform internal structure, respectively, and between the inner peripheral layer 21Aa and the outer peripheral layer 21Ab, It may be configured to have another layer (not shown) whose hardness or the like changes stepwise or gradually.
  • a part of the first portion 21A is sandwiched in the gap 11b between the adjacent strands 11a on the outer peripheral surface of the tip end portion of the first coil body 11.
  • a part or all of the inner peripheral surface of the first portion 21A is an outer peripheral surface (of the surface of the wire 11a) at the tip end portion of the first coil body 11. Examples thereof include those arranged so as to be in close contact with a part or all of the surface formed by the surface facing the outer side in the radial direction.
  • the entire inner peripheral surface of the first portion 21A and the entire outer peripheral surface at the tip of the first coil body 11 are arranged so as to be in close contact with each other (the first portion 21A is the first coil body). It is arranged so as to evenly fill the gap 11b between the strands 11a constituting the 11.
  • the portion sandwiched in the gap 11b between the adjacent strands 11a of the first coil body 11 may be only the inner peripheral layer 21Aa, or both the inner peripheral layer 21Aa and the outer peripheral layer 21Ab. ..
  • the first portion 21A is sandwiched in the gap 11b between the adjacent strands 11a on the outer peripheral surface of the tip end portion of the first coil body 11, so that the first portion 21A is first.
  • the second part 21B is a part extending from the tip of the first coil body 11 toward the tip side and continuous with the first part 21A.
  • the second portion 21B includes, for example, an inner peripheral layer 21Ba including the inner peripheral surface of the second portion 21B, and an outer peripheral layer 21Bb arranged radially outside the inner peripheral layer 21B and including the outer peripheral surface of the second portion 21B. Can be configured to have.
  • the hardness of the inner peripheral layer 21Ba is larger than the hardness of the outer peripheral layer 21Bb. As a result, it is possible to reliably prevent the contacted object from being damaged and the second portion 21B from being damaged due to contact with the contacted object.
  • the inner peripheral layer 21Ba is integrally formed with the inner peripheral layer 21Aa using the same material as the inner peripheral layer 21Aa in the first portion 21A. It is also preferable that As a result, it is possible to reliably prevent the tip tip portion (first portion 21A and second portion 21B) from coming off from the hollow shaft (first coil body 11 and third portion 21C).
  • the third part 21C is a part of the tubular body 21 other than the first part 21A and the second part 21B.
  • the third portion 21C can be configured to be continuous with the proximal end of the first portion 21A and extend toward the proximal end side along the first coil body 11, for example.
  • the third site 21C may be formed of a single layer (see FIG. 1) or may be formed of a plurality of layers (not shown).
  • the materials constituting the first site 21A, the second site 21B, and the third site 21C have antithrombotic properties, flexibility, and biocompatibility because the medical tubular body 1 is inserted into the body cavity. It is preferable to do so.
  • the material include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, polyester elastomer, polyurethane, polyurethane elastomer, silicone, and fluororesin.
  • the combination of the materials constituting the first portion 21A two kinds of the above materials may be combined depending on the hardness, but the same kind of materials may be combined.
  • the relationship of hardness between the inner peripheral layer 21Aa and the outer peripheral layer 21Ab can be adjusted by using materials of different grades, for example.
  • the usage mode of the medical tubular body 1 will be described.
  • a procedure in which the medical tubular body 1 is used as a guiding catheter and the medical tubular body 1 is inserted up to the coronary artery of the heart is illustrated.
  • a guide wire A (not shown) is inserted into a blood vessel, and the tip thereof is sent close to the entrance of the coronary artery of the heart.
  • the base end of the guide wire A is inserted into the opening 21h provided at the tip of the medical tubular body 1, and along the guide wire A so that the tip of the medical tubular body 1 reaches the entrance of the coronary artery of the heart.
  • the medical tubular body 1 is pushed forward while being pushed into the blood vessel. At this time, the medical tubular body 1 advances in the blood vessel without damaging the inner wall of the curved blood vessel and without the tip end portion coming off the hollow shaft.
  • a thinner guide wire B (not shown)
  • another medical device such as a balloon catheter is sent to the treatment site via the medical tubular body 1. Treat with. After the treatment, the procedure is completed by sequentially removing the other medical device, the medical tubular body 1, and the guide wire B from the body.
  • the outer peripheral layer 21Ab is softer than the inner peripheral layer 21Aa, the outer peripheral layer 21Ab suppresses damage to the object to be contacted, and the inner circumference is harder than the outer peripheral layer 21Ab. Since the layer 21Aa covers the outer circumference of the first coil body 11, the tip tip and the hollow shaft can be firmly connected, and the tip tip portion can be prevented from coming off from the hollow shaft.
  • the medical tubular body 1 includes the first coil body 11, the rotational force applied to the base end portion of the medical tubular body 1 can be reliably transmitted to the tip end portion, and the tip end portion can be reliably transmitted.
  • the medical tubular body 1 can be smoothly inserted into the body cavity while rotating the body appropriately.
  • FIG. 2 is a schematic vertical sectional view showing a second embodiment of the present invention.
  • the medical tubular body 2 is roughly composed of a first coil body 12, a second coil body 42, a tubular body 22, and a connector 31.
  • the medical tubular body 2 is different from the first embodiment in that it includes a first coil body 12, a second coil body 42, and a tubular body 22. Since the configuration of the connector 31 is the same as that of the first embodiment, the same parts are designated by the same reference numerals and detailed description thereof will be omitted. Further, since the configurations other than the configurations of the first coil body 12, the second coil body 42, and the tubular body 22 shown below are the same as those of the first embodiment, the description thereof will be omitted.
  • the first coil body 12 is a spiral member formed by winding a wire 12a.
  • the first coil body 12 can be configured to have, for example, a tapered portion in which the outer diameter of the tip end is smaller than the outer diameter of the base end.
  • the second coil body 42 is a spiral member arranged on the outer side in the radial direction of the first coil body 12 and formed by winding a wire 42a.
  • a part of the second coil body 42 is embedded in the inner peripheral layer 22Aa and the outer peripheral layer 22Ab of the tubular body 22, which will be described later (at least a part of the radial inner side of the second coil body 42 is embedded in the inner peripheral layer 22Aa).
  • the second coil body 42 and the first coil body 12 may be in direct contact with each other, or an inner peripheral layer 22Aa may be interposed between them. Thereby, it is possible to more reliably prevent the second portion 22B of the tubular body 22 from coming off from the first portion 22A.
  • the second coil body 42 can be formed, for example, by using one or a plurality of strands 42a and winding it on the outer peripheral surface of the first coil body 12, for example.
  • the second coil body 42 may be either a single-row coil body or a multi-row coil body.
  • the strand 42a may be a single wire or a stranded wire.
  • the material of the wire forming the second coil body 42 since the medical tubular body 2 is inserted into the body cavity, it has antithrombotic property, flexibility and biocompatibility. preferable.
  • Examples of such a material include materials similar to the material of the wire 12a constituting the first coil body 12.
  • the tubular body 22 has, for example, a first part 22A, a second part 22B, and a third part 22C.
  • the first portion 22A is a portion that covers the outer periphery of the tip end portion of the first coil body 12.
  • the first portion 22A has an inner peripheral layer 22Aa including the inner peripheral surface of the first portion 22A and an outer peripheral layer 22Ab arranged radially outside the inner peripheral layer 22Aa and including the outer peripheral surface of the first portion 22A. doing.
  • the first portion 22A is formed so that the hardness of the inner peripheral layer 22Aa is larger than the hardness of the outer peripheral layer 22Ab.
  • the second portion 22B is a portion extending from the tip of the first coil body 12 toward the tip side and continuous with the first portion 22A. As described above, in the tubular body 22, a part of the second coil body 42 is embedded in the inner peripheral layer 22Aa and the outer peripheral layer 22Ab.
  • the tubular body 22 may have a tapered portion T whose tip outer diameter is smaller than the base end outer diameter, as in the medical tubular body 2.
  • the tapered portion T can be obtained by forming a tubular body having a constant thickness along the outer circumference of the tapered portion of the first coil body 12 described above.
  • the medical tubular body 2 can be used, for example, as a dilator for expanding the diameter of a pre-drilled hole.
  • the tapered portion T may be provided at the tip tip portion (first portion 22A and / or second portion 22B), and is provided at a portion other than the tip tip portion (third portion 22C) as shown in FIG. May be good.
  • the medical tubular body 2 When the medical tubular body 2 is used as a dilator, it is preferable that a part of the second coil body 42 protrudes from the surface of the tubular body 22. As a result, a propulsive force can be generated by the screwing action accompanying the rotation of the medical tubular body 2.
  • the medical tubular body 2 when used as a dilator, at least a part of the strands 42a of the second coil body 42 has a gap 42b between adjacent portions along the axial direction of the tubular body 22. Is preferable. As a result, the propulsive force due to the screwing action accompanying the rotation of the medical tubular body 2 can be generated more strongly.
  • the medical tubular body 2 when used as a dilator, it is also preferable that at least a part of the second coil body 42 is located at a portion of the tapered portion T in the long axis direction. As a result, it is possible to obtain a large propulsive force for countering the drag force from the contacted object generated when the medical tubular body 2 expands the diameter of the hole, and the medical tubular body 2 can be reliably advanced. it can.
  • the usage mode of the medical tubular body 2 will be described.
  • a procedure in which the medical tubular body 2 is used as a dilator and the medical tubular body 2 expands the puncture hole is illustrated.
  • an introduction needle (not shown) is projected from the tip of an endoscope (not shown) inserted through the patient's mouth or nose, and a puncture hole is punctured at a predetermined position on the wall of the gastrointestinal tract such as the patient's stomach.
  • the guide wire C (not shown) into the puncture hole
  • the base end of the guide wire C is inserted into the opening 22h provided at the tip of the medical tubular body 2, and the medical tubular body 2 is inserted.
  • the tip of the guide wire C is inserted into the puncture hole along the guide wire C.
  • the tip portion having a soft surface is the first because a part of the second coil body 42 is embedded in the inner peripheral layer 22Aa. Can be securely fixed to the coil body 12 of the above, damage to the object to be contacted can be suppressed, and the tip end portion can be prevented from coming off from the hollow shaft.
  • the medical tubular body 2 includes a second coil body 42, a propulsive force due to a screw action can be generated by rotating the medical tubular body 2, for example, a digestive tract or the like. It is possible to smoothly move forward and backward in the hole formed in the wall of the wall.
  • the medical tubular body 2 includes a tubular body 22 having a tapered portion T whose tip outer diameter is smaller than the outer diameter of the base end, a hole in which the medical tubular body 2 is pre-drilled is provided. By passing it through (contacted object), the diameter of the hole can be expanded by the outer peripheral surface of the tapered portion T, and it can be used as a dilator.
  • the medical tubular body 1 having the inner peripheral layers 21Aa and 21Ba and the outer peripheral layers 21Ab and 21Bb in both the first site 21A and the second site 21B has been described, but the second site 21Bm1 It may be a medical tubular body 1m1 having a tubular body 21m1 having an outer peripheral layer 21Bbm1 only on a part on the inner peripheral layer 21Ba (see FIG. 3A), and a second portion 21Bm2 is an outer peripheral layer on the inner peripheral layer 21Ba. It may be a medical tubular body 1m2 (a medical tubular body 1m2 in which the second site 21Bm2 is composed of a single layer) having a tubular body 21m2 having no structure (see FIG. 3B).
  • the medical tubular body is arranged so that the entire inner peripheral surface of the first portion 21A and the entire outer peripheral surface at the tip of the first coil body 11 are in close contact with each other.
  • the first portion covers the outer periphery of the tip portion of the first coil body, and the first portion 21Am3 is sandwiched only in a part of the gap 11b between the adjacent strands 11a.
  • It may be a medical tubular body 1m3 (see FIG. 4A) having the tubular body 21m3, and the first portion 21Am4 (for example, the inner peripheral layer 21Am4) is not sandwiched in the gap 11b between the strands 11a.
  • It may be a medical tubular body 1 m4 having a body 21 m4 (see FIG. 4B).
  • the medical tubular body 2 in which the tubular body 22 has the tapered portion T and the second coil body 42 protrudes from the surface of the tubular body 22 has been described. It may be a medical tubular body 2m5 (see FIG. 5A) having a tubular body 22m5 having no second coil body 42m5, and the second coil body 42m6 protrudes from the surface of the tubular body 22m6. It may be a non-medical tubular body 2 m6 (see FIG. 5B).
  • the medical tubular body 2 in which at least a part of the second coil body 42 is located at the portion of the tapered portion T in the major axis direction has been described, but the second coil The body 42m7 may be a medical tubular body 2m7 located only in a portion other than the tapered portion T of the tubular body 22m7 in the longitudinal direction (see FIG. 5C).
  • the first coil body 12 is provided with a tapered portion, and a medical tubular body 22 having a tubular body 22 formed with a constant thickness along the outer periphery of the tapered portion is provided.
  • the tapered portion T may be formed by adjusting the thickness of the tubular body without providing the tapered portion on the first coil body (see FIG. 5C).

Abstract

L'objectif de la présente invention est de fournir un corps tubulaire médical qui peut empêcher un embout d'extrémité avant de celui-ci de sortir d'un arbre creux et qui réduit au minimum un endommagement d'un objet qui vient en contact avec celui-ci.　Un corps tubulaire médical 1 selon la présente invention est caractérisé en ce qu'il comporte : un premier corps spiralé 11 formé par enroulement d'un fil 11a ; et un corps tubulaire 21 qui a une première partie 21A recouvrant la circonférence externe d'une partie d'extrémité avant du premier corps spiralé 11 et une seconde partie 21B qui s'étend à partir de la pointe du premier corps spiralé 11 vers le côté d'extrémité avant et qui est contiguë à la première partie 21A, la première partie 21A ayant une couche circonférentielle interne 21Aa qui comprend la surface circonférentielle interne de la première partie 21A et une couche circonférentielle externe 21Ab qui comprend la surface circonférentielle externe de la première partie 21A et qui est disposée radialement vers l'extérieur de la couche circonférentielle interne 21Aa et la couche circonférentielle interne 21Aa a une dureté supérieure à celle de la couche circonférentielle externe 21Ab.
PCT/JP2019/039178 2019-10-03 2019-10-03 Corps tubulaire médical WO2021064955A1 (fr)

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JP2021550894A JP7339355B2 (ja) 2019-10-03 2019-10-03 医療用管状体
PCT/JP2019/039178 WO2021064955A1 (fr) 2019-10-03 2019-10-03 Corps tubulaire médical

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Application Number Priority Date Filing Date Title
PCT/JP2019/039178 WO2021064955A1 (fr) 2019-10-03 2019-10-03 Corps tubulaire médical

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US11395665B2 (en) 2018-05-01 2022-07-26 Incept, Llc Devices and methods for removing obstructive material, from an intravascular site
US11439799B2 (en) 2019-12-18 2022-09-13 Imperative Care, Inc. Split dilator aspiration system
US11471582B2 (en) 2018-07-06 2022-10-18 Incept, Llc Vacuum transfer tool for extendable catheter
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US11903588B2 (en) 2017-01-06 2024-02-20 Incept, Llc Thromboresistant coatings for aneurysm treatment devices

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Publication number Priority date Publication date Assignee Title
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US11553935B2 (en) 2019-12-18 2023-01-17 Imperative Care, Inc. Sterile field clot capture module for use in thrombectomy system
US11439799B2 (en) 2019-12-18 2022-09-13 Imperative Care, Inc. Split dilator aspiration system
US11565082B2 (en) 2020-03-10 2023-01-31 Imperative Care, Inc. Enhanced flexibility neurovascular catheter

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