WO2021064955A1 - Medical tubular body - Google Patents

Medical tubular body 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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French (fr)
Japanese (ja)
Inventor
友希弘 伏屋
麻里奈 北井
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朝日インテック株式会社
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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/en
Priority to PCT/JP2019/039178 priority patent/WO2021064955A1/en
Publication of WO2021064955A1 publication Critical patent/WO2021064955A1/en

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    • 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

The purpose of the present invention is to provide a medical tubular body which is capable of keeping a leading-end tip thereof from coming off a hollow shaft and which minimizes damage to an object that comes into contact therewith.　A medical tubular body 1 according to the present invention is characterized by being provided with: a first coiled body 11 formed by winding a wire 11a; and a tubular body 21 which has a first portion 21A covering the outer circumference of a leading end part of the first coiled body 11 and a second portion 21B that extends from the tip of the first coiled body 11 toward the leading-end side and that is contiguous to the first portion 21A, wherein the first portion 21A has an inner circumferential layer 21Aa that includes the inner circumferential surface of the first portion 21A and an outer circumferential layer 21Ab that includes the outer circumferential surface of the first portion 21A and that is disposed radially outward of the inner circumferential layer 21Aa, and the inner circumferential layer 21Aa has a hardness greater than that of the outer circumferential layer 21Ab.

Description

医療用管状体Medical tubular body
　本発明は、医療用管状体に関する。 The present invention relates to a medical tubular body.
　血管などの体腔に挿入されるカテーテルは、デリケートな内壁への損傷を低減するため、例えば、インナーチューブの先端に柔軟なチップが延設されている（例えば、特許文献１参照）。 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).
　このようなカテーテルを用いた手技では、カテーテルを体腔へ挿入し、体腔内を進行する際の体腔内壁の損傷を抑制することができる。 In such a procedure using a catheter, it is possible to insert the catheter into the body cavity and suppress damage to the inner wall of the body cavity when proceeding in the body cavity.
特開２０１１－２１２４９３号公報Japanese Unexamined Patent Publication No. 2011-212493
　しかしながら、上述したような従来のカテーテルは、インナーチューブの先端とチップの基端とが単に突き合わされて接合されているに過ぎない。このため、インナーチューブとチップとの接合強度が乏しくなる傾向にあり、カテーテルを体腔への挿入する際、チップがインナーチューブから外れてしまう虞がある。 However, in the conventional catheter as described above, 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.
　本発明は、以上のような事情に基づいてなされたものであり、その目的は、被接触物への損傷を抑制しかつ先端チップ部が中空シャフトから外れるのを防止することが可能な医療用管状体を提供することにある。 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. To provide a tubular body.
　本開示のいくつかの態様は、
（１）素線を巻回して形成された第１のコイル体と、
　前記第１のコイル体の先端部の外周を覆う第１部位と、前記第１のコイル体の先端から先端側に向かって延設されかつ前記第１部位に連続する第２部位と、を有する管状体と、
を備え、
　前記第１部位は、この第１部位の内周面を含む内周層と、前記内周層よりも径方向外側に配置され前記第１部位の外周面を含む外周層と、を有し、
　前記内周層の硬度が、前記外周層の硬度よりも大きい医療用管状体、
（２）前記第１部位の一部が、前記第１のコイル体の先端部の外周面における隣り合う前記素線間の隙間に挟入されている前記（１）に記載の医療用管状体、
（３）前記第１のコイル体の径方向外側に配置され、素線を巻回して形成された第２のコイル体を備え、
　前記第２のコイル体の一部が、前記内周層および外周層に埋設されている前記（１）または（２）に記載の医療用管状体、並びに
（４）前記管状体は、先端の外径が基端の外径よりも小さいテーパ部を有する前記（３）に記載の医療用管状体、である。 Some aspects of this disclosure include
(1) 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.
A medical tubular body in which the hardness of the inner peripheral layer is larger than the hardness of the outer peripheral layer.
(2) 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. ,
(3) 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 (1) or (2), wherein a part of the second coil body is embedded in the inner peripheral layer and the outer peripheral layer, and (4) the tubular body has a tip. 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.
　なお、本明細書において、「先端側」とは、長軸方向に沿う方向であって、管状体の第１部位に対して第２部位が位置する方向を意味する。「基端側」とは、長軸方向に沿う方向であって、先端側と反対側の方向を意味する。但し、「長軸方向」とは、医療用管状体の長手方向に沿う方向を意味する。「先端」とは、任意の部材または部位における先端側の端部、「基端」とは、任意の部材または部位における基端側の端部をそれぞれ示す。「先端部」とは、任意の部材または部位において、その先端を含みこの先端から基端側に向かって中途まで延びる部位を指す。「硬度」とは、ＪＩＳ　Ｋ７２１５（１９８６）に規定の「プラスチックのデュロメータ硬さ試験方法」に準拠して測定した「硬さ」を指す。 In the present specification, 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. However, 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).
　本発明は、被接触物への損傷を抑制しかつ先端チップ部が中空シャフトから外れるのを防止することが可能な医療用管状体を提供することができる。 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.
本発明の第１の実施形態を示す概略的縦断面図である。It is a schematic vertical sectional view which shows the 1st Embodiment of this invention. 本発明の第２の実施形態を示す概略的縦断面図である。It is a schematic vertical sectional view which shows the 2nd Embodiment of this invention. 第１の実施形態の変形例を示す概略的縦断面図である。It is a schematic vertical sectional view which shows the modification of 1st Embodiment. 第１の実施形態の変形例を示す概略的縦断面図である。It is a schematic vertical sectional view which shows the modification of 1st Embodiment. 第１の実施形態の変形例を示す一部拡大概略的縦断面図である。It is a partially enlarged schematic vertical sectional view which shows the modification of the 1st Embodiment. 第１の実施形態の変形例を示す一部拡大概略的縦断面図である。It is a partially enlarged schematic vertical sectional view which shows the modification of the 1st Embodiment. 第２の実施形態の変形例を示す概略的縦断面図である。It is a schematic vertical sectional view which shows the modification of the 2nd Embodiment. 第２の実施形態の変形例を示す概略的縦断面図である。It is a schematic vertical sectional view which shows the modification of the 2nd Embodiment. 第２の実施形態の変形例を示す概略的縦断面図である。It is a schematic vertical sectional view which shows the modification of the 2nd Embodiment.
　当該医療用管状体は、素線を巻回して形成された第１のコイル体と、上記第１のコイル体の先端部の外周を覆う第１部位と、上記第１のコイル体の先端から先端側に向かって延設されかつ上記第１部位に連続する第２部位と、を有する管状体と、を備え、上記第１部位は、この第１部位の内周面を含む内周層と、上記内周層よりも径方向外側に配置され上記第１部位の外周面を含む外周層と、を有し、上記内周層の硬度が、上記外周層の硬度よりも大きいことを特徴とする。 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. To do.
　なお、本明細書において、「径方向外側」とは、上記長軸方向に直交する方向であって医療用管状体の長手方向の中心軸から離間する方向を意味する。また、本明細書では、第１部位と第２部位とを合わせて「先端チップ部」、第１のコイル体と第３部位とを合わせて「中空シャフト」とも称する。 In the present specification, 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. Further, in the present specification, the first portion and the second portion are collectively referred to as a "tip tip portion", and the first coil body and the third portion are collectively referred to as a "hollow shaft".
　以下、本発明の第１および第２の実施形態について図面を参照して説明するが、本発明は、当該図面に記載の実施形態にのみ限定されるものではない。また、各図面に示した医療用管状体の寸法は、実施内容の理解を容易にするために示した寸法であり、実際の寸法に対応するものではない。 Hereinafter, the first and second embodiments of the present invention will be described with reference to the drawings, but the present invention is not limited to the embodiments described in the drawings. Further, the dimensions of the medical tubular body shown in each drawing are the dimensions shown for facilitating the understanding of the implementation contents, and do not correspond to the actual dimensions.
［第１の実施形態］
　図１は、本発明の第１の実施形態を示す概略的縦断面図である。当該医療用管状体１は、図１に示すように、概略的に、第１のコイル体１１と、管状体２１と、コネクタ３１とにより構成されている。 [First Embodiment]
FIG. 1 is a schematic vertical sectional view showing a first embodiment of the present invention. As shown in FIG. 1, the medical tubular body 1 is roughly composed of a first coil body 11, a tubular body 21, and a connector 31.
　第１のコイル体１１は、素線１１ａを巻回して形成された螺旋状の部材である。第１のコイル体１１は、具体的には、例えば、１本または複数の素線１１ａを用い、長軸方向に沿って隣り合う素線１１ａを巻回することで形成することができる。第１のコイル体１１は、単条のコイル体または多条のコイル体のいずれであってもよい。素線１１ａは、単線であってもよく撚線であってもよい。但し、単線とは１本の単一線を意味し、撚線とは複数本の単一線を予め互いに撚り合って形成した一束の線群を意味する。 The first coil body 11 is a spiral member formed by winding a wire 11a. Specifically, 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. However, the single wire means one single wire, and the stranded wire means a bundle of wires formed by twisting a plurality of single wires in advance.
　第１のコイル体１１を構成する素線１１ａの材料としては、当該医療用管状体１が体腔内に挿通されることから、抗血栓性、可撓性および生体適合性を有していることが好ましい。このような材料としては、例えば、ステンレス鋼、超弾性合金（ニッケル－チタン合金）などの金属材料；ポリアミド樹脂やフッ素樹脂などの樹脂材料等が挙げられる。 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. Examples of such a material include metal materials such as stainless steel and superelastic alloys (nickel-titanium alloys); resin materials such as polyamide resins and fluororesins.
　管状体２１は、例えば、第１部位２１Ａと、第２部位２１Ｂと、第３部位２１Ｃとにより構成することができる。 The tubular body 21 can be composed of, for example, a first part 21A, a second part 21B, and a third part 21C.
　第１部位２１Ａは、第１のコイル体１１の先端部の外周を覆う部位である。第１部位２１Ａは、この第１部位２１Ａの内周面を含む内周層２１Ａａと、内周層２１Ａａよりも径方向外側に配置され第１部位２１Ａの外周面を含む外周層２１Ａｂと、を有している。 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.
　第１部位２１Ａは、内周層２１Ａａの硬度が外周層２１Ａｂの硬度よりも大きくなるように形成されている。具体的には、上述したＪＩＳ　Ｋ７２１５（１９８６）の規定に準拠し、例えば、デュロメータの押針を用いて測定した第１部位２１Ａの内周面の硬さが、第１部位２１Ａの外周面の硬さよりも大きく（硬く）なるように構成することができる。 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. Specifically, in accordance with the above-mentioned JIS K7215 (1986), for example, 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.
　なお、第１部位２１Ａは、内部の構成がそれぞれ均一な内周層２１Ａａおよび外周層２１Ａｂの二つの層のみからなる構成であってもよく、内周層２１Ａａと外周層２１Ａｂとの間に、硬さなどが段階的または漸次変化する他の層（不図示）を有する構成であってもよい。 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.
　ここで、第１部位２１Ａは、その一部が第１のコイル体１１の先端部の外周面における隣り合う素線１１ａ間の隙間１１ｂに挟入されていることが好ましい。このような第１部位２１Ａの態様としては、例えば、第１部位２１Ａの内周面の一部または全部が、第１のコイル体１１の先端部における外周面（素線１１ａの表面のうちの径方向外側に臨む表面で形成される面）の一部または全部に密着するように配置されたもの等が挙げられる。なお、本実施形態では、第１部位２１Ａの内周面の全部と第１のコイル体１１の先端部における外周面の全部とが密着するように配置（第１部位２１Ａが第１のコイル体１１を構成する素線１１ａ間の隙間１１ｂを万遍なく満たすように配置）されている。第１のコイル体１１の隣り合う素線１１ａ間の隙間１１ｂに挟入される部位は、内周層２１Ａａのみであってもよく、内周層２１Ａａおよび外周層２１Ａｂの両者であってもよい。 Here, it is preferable that 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. In such an aspect of the first portion 21A, for example, 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. In the present embodiment, 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. ..
　このように、第１部位２１Ａの一部が第１のコイル体１１の先端部の外周面における隣り合う素線１１ａ間の隙間１１ｂに挟入されていることで、第１部位２１Ａを第１のコイル体１１に係止することができ、第１部位２１Ａおよび第１部位２１Ａに連続する第２部位２１Ｂ（後述）が第１のコイル体１１から外れるのを確実に防止することができる。 In this way, 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, so that the first portion 21A is first. Can be locked to the coil body 11 of the above, and the second portion 21B (described later) continuous with the first portion 21A and the first portion 21A can be reliably prevented from coming off from the first coil body 11.
　第２部位２１Ｂは、第１のコイル体１１の先端から先端側に向かって延設されかつ第１部位２１Ａに連続する部位である。第２部位２１Ｂは、例えば、第２部位２１Ｂの内周面を含む内周層２１Ｂａと、内周層２１Ｂａよりも径方向外側に配置され第２部位２１Ｂの外周面を含む外周層２１Ｂｂと、を有するように構成することができる。 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.
　第２部位２１Ｂが内周層２１Ｂａと外周層２１Ｂｂとを有する場合、内周層２１Ｂａの硬度が外周層２１Ｂｂの硬度よりも大きいことが好ましい。これにより、被接触物が損傷したり、被接触物との接触により第２部位２１Ｂが破損したりすることを確実に抑制することができる。 When the second portion 21B has an inner peripheral layer 21Ba and an outer peripheral layer 21Bb, it is preferable that 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.
　また、第２部位２１Ｂが内周層２１Ｂａと外周層２１Ｂｂとを有する場合、内周層２１Ｂａが第１部位２１Ａにおける内周層２１Ａａと同じ材料を用いて内周層２１Ａａと一体的に形成されていることも好ましい。これにより、先端チップ部（第１部位２１Ａおよび第２部位２１Ｂ）が中空シャフト（第１のコイル体１１および第３部位２１Ｃ）から外れるのを確実に防止することができる。 When the second portion 21B has an inner peripheral layer 21Ba and an outer peripheral layer 21Bb, 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).
　第３部位２１Ｃは、管状体２１における第１部位２１Ａおよび第２部位２１Ｂ以外の部位である。第３部位２１Ｃは、例えば、第１部位２１Ａの基端に連続しかつ第１のコイル体１１に沿って基端側に延設するように構成することができる。第３部位２１Ｃは、単一の層で形成されていてもよく（図１参照）、複数の層で形成されていてもよい（不図示）。 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).
　第１部位２１Ａ、第２部位２１Ｂ、および第３部位２１Ｃを構成する材料は、当該医療用管状体１が体腔内に挿通されることから、抗血栓性、可撓性および生体適合性を有していることが好ましい。上記材料としては、例えば、ポリアミド、ポリアミドエラストマー、ポリオレフィン、ポリエステル、ポリエステルエラストマー、ポリウレタン、ポリウレタンエラストマー、シリコーン、フッ素樹脂などの樹脂材料等が挙げられる。 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. Examples of the material include resin materials such as polyamide, polyamide elastomer, polyolefin, polyester, polyester elastomer, polyurethane, polyurethane elastomer, silicone, and fluororesin.
　第１部位２１Ａを構成する材料の組み合わせとしては、硬さに応じ、上記材料のうちの２種の材料を組み合わせることもできるが、同種の材料を組み合わせてもよい。同種の材料を組み合わせる場合、グレードの異なる材料を使用することで、例えば、内周層２１Ａａと外周層２１Ａｂとの硬さの関係を調整することができる。 As 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. When combining materials of the same type, 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.
　次に、当該医療用管状体１の使用態様について説明する。ここでは、医療用管状体１をガイディングカテーテルとして用い、医療用管状体１を心臓の冠動脈まで挿入する手技を例示する。 Next, the usage mode of the medical tubular body 1 will be described. Here, 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.
　当該医療用管状体１の使用に先立ち、まず、ガイドワイヤＡ（不図示）を血管内に挿入し、その先端を心臓の冠動脈入口近くまで送り込む。次いで、当該医療用管状体１の先端に設けられた開口２１ｈにガイドワイヤＡの基端を挿入し、医療用管状体１の先端が心臓の冠動脈入口まで達するように、ガイドワイヤＡに沿って医療用管状体１を血管内に押し込みながら前進させる。この際、当該医療用管状体１は、湾曲する血管の内壁を傷つけずかつ先端チップ部が中空シャフトから外れることなく血管内を進行する。 Prior to the use of the medical tubular body 1, first, 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. Next, 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.
　次に、ガイドワイヤＡを抜き取ってより細いガイドワイヤＢ（不図示）に入れ替えた後、当該医療用管状体１を介してバルーンカテーテルなどの他の医療器具（不図示）を処置部位まで送り込むことで治療を行う。治療後は、上記他の医療器具、医療用管状体１、およびガイドワイヤＢを体外に順次抜去することで手技が完了する。 Next, after the guide wire A is pulled out and replaced with a thinner guide wire B (not shown), another medical device (not shown) 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.
　以上のように、当該医療用管状体１は、外周層２１Ａｂが内周層２１Ａａに比べて柔らかい分、外周層２１Ａｂにより被接触物への損傷を抑制すると共に、外周層２１Ａｂよりも硬い内周層２１Ａａが第１のコイル体１１の外周を覆っている分、先端チップと中空シャフトとを強固に接続することができ、先端チップ部が中空シャフトから外れるのを防止することができる。 As described above, in the medical tubular body 1, since 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.
　また、当該医療用管状体１は、第１のコイル体１１を備えているので、医療用管状体１の基端部に加えた回転力を先端部まで確実に伝達することができ、先端部を適宜回転させながら医療用管状体１を体腔内に円滑に挿入することができる。 Further, since 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.
［第２の実施形態］
　図２は、本発明の第２の実施形態を示す概略的縦断面図である。当該医療用管状体２は、図２に示すように、概略的に、第１のコイル体１２と、第２のコイル体４２と、管状体２２と、コネクタ３１とにより構成されている。当該医療用管状体２は、第１のコイル体１２、第２のコイル体４２および管状体２２を備えている点で第１の実施形態と異なっている。なお、コネクタ３１の構成は、第１の実施形態と同様であるので、同一部分には同一符号を付してその詳細な説明を省略する。また、以下に示す第１のコイル体１２、第２のコイル体４２および管状体２２の構成以外の構成は、第１の実施形態と同様であるので、その説明を省略する。 [Second Embodiment]
FIG. 2 is a schematic vertical sectional view showing a second embodiment of the present invention. As shown in FIG. 2, 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.
　第１のコイル体１２は、素線１２ａを巻回して形成された螺旋状の部材である。第１のコイル体１２は、例えば、先端の外径が基端の外径よりも小さいテーパ状の部位を有するように構成することができる。 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.
　第２のコイル体４２は、第１のコイル体１２の径方向外側に配置され、素線４２ａを巻回して形成された螺旋状の部材である。第２のコイル体４２は、その一部が後述する管状体２２の内周層２２Ａａおよび外周層２２Ａｂに埋設（第２のコイル体４２の径方向内側の少なくとも一部が内周層２２Ａａに埋設）するように配設することができる。第２のコイル体４２と第１のコイル体１２とは直接接触していてもよく、これらの間に内周層２２Ａａが介在していてもよい。これにより、管状体２２の第２部位２２Ｂが第１部位２２Ａから外れるのをより確実に防止することができる。 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). ) Can be arranged. 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.
　第２のコイル体４２は、具体的には、例えば、１本または複数本の素線４２ａを用い、例えば、第１のコイル体１２の外周面上に巻回して形成することができる。第２のコイル体４２は、単条のコイル体または多条のコイル体のいずれであってもよい。素線４２ａは、単線であってもよく撚線であってもよい。 Specifically, 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.
　第２のコイル体４２を構成する素線の材料としては、当該医療用管状体２が体腔内に挿通されることから、抗血栓性、可撓性および生体適合性を有していることが好ましい。このような材料としては、例えば、第１のコイル体１２を構成する素線１２ａの材料と同様の材料等が挙げられる。 As 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.
　管状体２２は、例えば、第１部位２２Ａと、第２部位２２Ｂと、第３部位２２Ｃとを有している。第１部位２２Ａは、第１のコイル体１２の先端部の外周を覆う部位である。第１部位２２Ａは、この第１部位２２Ａの内周面を含む内周層２２Ａａと、内周層２２Ａａよりも径方向外側に配置され第１部位２２Ａの外周面を含む外周層２２Ａｂとを有している。第１部位２２Ａは、内周層２２Ａａの硬度が外周層２２Ａｂの硬度よりも大きくなるように形成されている。第２部位２２Ｂは、第１のコイル体１２の先端から先端側に向かって延設されかつ第１部位２２Ａに連続する部位である。管状体２２は、上述したように、第２のコイル体４２の一部が内周層２２Ａａおよび外周層２２Ａｂに埋設されている。 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.
　管状体２２は、当該医療用管状体２のように、先端の外径が基端の外径よりも小さいテーパ部Ｔを有していてもよい。テーパ部Ｔは、具体的には、例えば、上述した第１のコイル体１２のテーパ状の部位の外周に沿うように、一定厚みで管状体を形成することで得ることができる。このように管状体２２がテーパ部Ｔを有する場合、当該医療用管状体２は、例えば、予め穿設された孔を拡径するためのダイレータとして用いることができる。テーパ部Ｔは、先端チップ部（第１部位２２Ａおよび／または第２部位２２Ｂ）に設けられてもよく、図２に示すように先端チップ部以外の部位（第３部位２２Ｃ）に設けられてもよい。 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. Specifically, 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. When the tubular body 22 has the tapered portion T in this way, 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.
　なお、当該医療用管状体２をダイレータとして用いる場合、第２のコイル体４２の一部は、管状体２２の表面から突出していることが好ましい。これにより医療用管状体２の回転に伴うネジ作用により推進力を発生させることができる。 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.
　また、当該医療用管状体２をダイレータとして用いる場合、第２のコイル体４２の素線４２ａの少なくとも一部は、管状体２２の軸方向に沿って隣り合う部分の間に隙間４２ｂを有していることが好ましい。これにより医療用管状体２の回転に伴うネジ作用による推進力をより強力に発生させることができる。 Further, when the medical tubular body 2 is 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.
　また、当該医療用管状体２をダイレータとして用いる場合、第２のコイル体４２の少なくとも一部は、長軸方向におけるテーパ部Ｔの部位に位置していることも好ましい。これにより、当該医療用管状体２が孔を拡径する際に生じる被接触物からの抗力に対抗するための大きな推進力を得ることができ、医療用管状体２を確実に前進させることができる。 Further, when the medical tubular body 2 is 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.
　次に、当該医療用管状体２の使用態様について説明する。ここでは、医療用管状体２をダイレータとして用い、医療用管状体２が穿刺孔を拡張する手技を例示する。 Next, the usage mode of the medical tubular body 2 will be described. Here, 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.
　まず、患者の口または鼻から挿入された内視鏡（不図示）の先端から導入針（不図示）を突出させ、患者の胃等の消化管の壁の所定位置に穿孔して穿刺孔を形成する。次いで、上記穿刺孔にガイドワイヤＣ（不図示）を挿通した後、当該医療用管状体２の先端に設けられた開口２２ｈにガイドワイヤＣの基端を挿入させ、当該医療用管状体２をガイドワイヤＣに沿わせながらその先端部を上記穿刺孔に挿入する。 First, 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. Form. Next, after inserting 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.
　次に、コネクタ３１を回転させる。その際、コネクタ３１の回転力は医療用管状体２の先端部まで伝達され、第２のコイル体４２のネジ作用等に伴う推進力により当該医療用管状体２を前進させながら、テーパ部Ｔにより穿刺孔の拡径を行う。次いで、コネクタ３１を逆回転させながら当該医療用管状体２を後退させ、医療用管状体２、およびガイドワイヤＣを体外に順次抜去することで手技が完了する。 Next, rotate the connector 31. At that time, the rotational force of the connector 31 is transmitted to the tip end portion of the medical tubular body 2, and the tapered portion T while advancing the medical tubular body 2 by the propulsive force accompanying the screwing action of the second coil body 42 or the like. The diameter of the puncture hole is enlarged by. Next, the medical tubular body 2 is retracted while rotating the connector 31 in the reverse direction, and the medical tubular body 2 and the guide wire C are sequentially removed from the body to complete the procedure.
　以上のように、当該医療用管状体２は、上記構成であるので、第２のコイル体４２の一部が内周層２２Ａａに埋設されている分、表面が柔らかな先端チップ部を第１のコイル体１２に確実に固定することができ、被接触物への損傷を抑制しかつ先端チップ部が中空シャフトから外れるのを防止することができる。 As described above, since the medical tubular body 2 has the above configuration, 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.
　また、当該医療用管状体２は、第２のコイル体４２を備えているので、当該医療用管状体２を回転することによりネジ作用による推進力を発生させることができ、例えば、消化管などの壁に形成された孔内を円滑に進退することができる。 Further, since 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.
　また、当該医療用管状体２は、先端の外径が基端の外径よりも小さいテーパ部Ｔを有する管状体２２を備えているので、当該医療用管状体２を予め穿設された孔（被接触物）に通することで、テーパ部Ｔの外周面により孔を拡径することができ、ダイレータとして用いることができる。 Further, since 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.
　なお、本発明は、上述した実施形態の構成に限定されるものではなく、特許請求の範囲によって示され、特許請求の範囲と均等の意味および範囲内での全ての変更が含まれることが意図される。 It should be noted that the present invention is not limited to the configuration of the above-described embodiment, but is indicated by the scope of claims, and is intended to include all modifications within the meaning and scope equivalent to the scope of claims. Will be done.
　例えば、上述した第１の実施形態では、第１部位２１Ａおよび第２部位２１Ｂともに内周層２１Ａａ，２１Ｂａおよび外周層２１Ａｂ，２１Ｂｂを有する医療用管状体１について説明したが、第２部位２１Ｂｍ１が内周層２１Ｂａ上の一部にのみ外周層２１Ｂｂｍ１を有する管状体２１ｍ１を備えた医療用管状体１ｍ１であってもよく（図３Ａ参照）、第２部位２１Ｂｍ２が内周層２１Ｂａ上に外周層を有しない管状体２１ｍ２を備えた医療用管状体１ｍ２（第２部位２１Ｂｍ２が単一の層からなる医療用管状体１ｍ２）であってもよい（図３Ｂ参照）。 For example, in the above-described first embodiment, 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).
　また、上述した第１の実施形態では、第１部位２１Ａの内周面の全部と第１のコイル体１１の先端部における外周面の全部とが密着するように配置されている医療用管状体１について説明したが、第１部位が第１のコイル体の先端部の外周を覆っていればよく、第１部位２１Ａｍ３が隣り合う素線１１ａ間の隙間１１ｂの一部にのみ挟入されている管状体２１ｍ３を備えた医療用管状体１ｍ３（図４Ａ参照）であってもよく、第１部位２１Ａｍ４（例えば、内周層２１Ａａｍ４）が素線１１ａ間の隙間１１ｂに挟入されていない管状体２１ｍ４を備えた医療用管状体１ｍ４（図４Ｂ参照）であってもよい。 Further, in the first embodiment described above, 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. Although 1 has been described, it is sufficient that 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).
　また、上述した第２の実施形態では、管状体２２がテーパ部Ｔを有しかつ第２のコイル体４２が管状体２２の表面から突出している医療用管状体２について説明したが、テーパ部を有さずかつ第２のコイル体４２ｍ５を有する管状体２２ｍ５を備えた医療用管状体２ｍ５（図５Ａ参照）であってもよく、第２のコイル体４２ｍ６が管状体２２ｍ６の表面から突出していない医療用管状体２ｍ６であってもよい（図５Ｂ参照）。 Further, in the second embodiment described above, 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).
　また、上述した第２の実施形態では、第２のコイル体４２の少なくとも一部が長軸方向におけるテーパ部Ｔの部位に位置している医療用管状体２について説明したが、第２のコイル体４２ｍ７が長軸方向において管状体２２ｍ７のテーパ部Ｔ以外の部位にのみ位置している医療用管状体２ｍ７であってもよい（図５Ｃ参照）。 Further, in the second embodiment described above, 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).
　また、上述した第２の実施形態では、テーパ状の部位を第１のコイル体１２に設け、上記テーパ状の部位の外周に沿うように一定厚みで形成した管状体２２を備えた医療用管状体２について説明したが、テーパ部Ｔは、第１のコイル体にテーパ状の部位を設けずに管状体の厚みを調整することで形成するようにしてもよい（図５Ｃ参照）。 Further, in the second embodiment described above, 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. Although the body 2 has been described, 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).
　１、２　医療用管状体
　１１、１２　第１のコイル体
　１１ａ　素線
　１１ｂ　隙間
　２１、２２　管状体
　２１Ａ、２２Ａ　第１部位
　２１Ａａ、２２Ａａ　内周層
　２１Ａｂ、２２Ａｂ　外周層
　２１Ｂ、２２Ｂ　第２部位
　４２　第２のコイル体
　Ｔ　テーパ部 1, 2 Medical tubular body 11, 12 1st coil body 11a Wire 11b Gap 21, 22 Tubular body 21A, 22A 1st part 21Aa, 22Aa Inner peripheral layer 21Ab, 22Ab Outer peripheral layer 21B, 22B 2nd part 42nd 2 coil body T taper part

Claims (4)

  1. 　素線を巻回して形成された第１のコイル体と、
    　前記第１のコイル体の先端部の外周を覆う第１部位と、前記第１のコイル体の先端から先端側に向かって延設されかつ前記第１部位に連続する第２部位と、を有する管状体と、
    を備え、
    　前記第１部位は、この第１部位の内周面を含む内周層と、前記内周層よりも径方向外側に配置され前記第１部位の外周面を含む外周層と、を有し、
    　前記内周層の硬度が、前記外周層の硬度よりも大きい医療用管状体。     The first coil body formed by winding the 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.
    A medical tubular body in which the hardness of the inner peripheral layer is larger than the hardness of the outer peripheral layer.
  2. 　前記第１部位の一部が、前記第１のコイル体の先端部の外周面における隣り合う前記素線間の隙間に挟入されている請求項１に記載の医療用管状体。 The medical tubular body according to claim 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.
  3. 　前記第１のコイル体の径方向外側に配置され、素線を巻回して形成された第２のコイル体を備え、
    　前記第２のコイル体の一部が、前記内周層および外周層に埋設されている請求項１または請求項２に記載の医療用管状体。     A second coil body arranged on the radial outer side of the first coil body and formed by winding a wire is provided.
    The medical tubular body according to claim 1 or 2, wherein a part of the second coil body is embedded in the inner peripheral layer and the outer peripheral layer.
  4. 　前記管状体は、先端の外径が基端の外径よりも小さいテーパ部を有する請求項３に記載の医療用管状体。 The medical tubular body according to claim 3, wherein the tubular body has a tapered portion in which the outer diameter of the tip is smaller than the outer diameter of the base end.
PCT/JP2019/039178 2019-10-03 2019-10-03 Medical tubular body WO2021064955A1 (en)

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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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