WO2023095694A1 - Catheter - Google Patents
Catheter Download PDFInfo
- Publication number
- WO2023095694A1 WO2023095694A1 PCT/JP2022/042508 JP2022042508W WO2023095694A1 WO 2023095694 A1 WO2023095694 A1 WO 2023095694A1 JP 2022042508 W JP2022042508 W JP 2022042508W WO 2023095694 A1 WO2023095694 A1 WO 2023095694A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- marker
- shaft
- catheter
- outer diameter
- lumen
- Prior art date
Links
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
Definitions
- the present invention relates to catheters used in lumens such as blood vessels.
- catheters that are used to selectively introduce into complex branching blood vessels in the body are generally pushed along a guide wire that has been previously introduced into the blood vessel to deliver therapeutic drugs and diagnostic imaging. Agents and the like can be distributed through the lumen.
- the catheter has a radiopaque marker placed on the shaft so that the position within the lumen can be recognized from outside the body (see, for example, Patent Document 1).
- Patent Document 1 describes a catheter in which the inner diameter of the lumen and the outer diameter of the catheter are constant by providing a marker on the small-diameter portion formed by partially deforming the reinforcing body wound around the inner layer.
- the present invention has been made in order to solve the above-described problems, and it is an object of the present invention to provide a catheter that can improve the insertability of the catheter into a biological lumen while maintaining the holdability and slidability of the guidewire. aim.
- a catheter for achieving the above object is a catheter comprising a shaft having a lumen communicating from a distal end to a proximal end, the shaft comprising a reinforcing body having a plurality of tubularly braided reinforcing wires, and an axis of the shaft.
- a radiopaque marker positioned in at least one central location, said marker positioned radially outward of said shaft relative to said stiffener, said marker positioned on said shaft.
- the inner diameter of the lumen of the marker-placed portion of the shaft is smaller than the inner diameter of the lumen of the marker-free portion of the shaft where the marker is not placed, and the outer diameter of the marker-placed portion is substantially equal to the outer diameter of the marker-free portion.
- the catheter configured as described above can effectively hold the guidewire inserted into the lumen by the marker placement portion with a small inner diameter.
- the inner diameter of the lumen in the marker-absent portion is larger than the inner diameter of the lumen in the marker-placed portion, the sliding resistance of the catheter as a whole against the guidewire can be reduced.
- the outer diameter of the marker-placed portion is substantially the same as the outer diameter of the marker-absent portion, it is possible to improve the insertability of the catheter into the biological lumen.
- the outer diameter of the marker may be equal to or less than the outer diameter of the reinforcing body.
- the shape of the outer peripheral surface of the marker may be substantially polygonal in a cross section perpendicular to the axial direction of the shaft.
- the outer diameter of the shaft is 0.5 mm or more and 0.9 mm or less
- the inner diameter of the lumen of the marker placement portion is 0.38 mm or more and 0.55 mm or less
- the inner diameter of the lumen of the marker absent portion is 0. .45 mm or more and 0.6 mm or less
- FIG. 4 is a cross-sectional view showing the distal end portion of the catheter according to the embodiment.
- FIG. 4 is an enlarged cross-sectional view showing the distal end portion of the catheter according to the embodiment;
- FIG. 3 is a plan view showing the outer layer of the catheter according to the embodiment.
- the catheter 1 is introduced into a blood vessel from the radial artery of the arm, the femoral artery of the leg, or the peripheral artery of the lower limb, is inserted into the artery of the lower limb, and is used for treatment, diagnosis, and the like.
- Catheter 1 is, for example, a support catheter, but may be a device for other uses.
- Arteries of the lower extremities are arteries near and more distal to the aortoiliac bifurcation.
- the catheter 1 has an elongated shaft 2, a hub 3 connected to the proximal end of the shaft 2, and an anti-kink protector 4 provided at the joint between the shaft 2 and the hub 3. ing.
- the shaft 2 is a tubular member having flexibility, and a lumen 5 is formed inside from the proximal end to the distal end.
- a guide wire is passed through the lumen 5 when the catheter 1 is inserted into the blood vessel.
- the lumen 5 can also be used as a passageway for liquid medicines, embolic substances, contrast media, medical instruments, and the like.
- the effective length of the shaft 2 is not particularly limited, it is preferably 200 mm to 2600 mm, more preferably 400 mm to 2300 mm, still more preferably 600 mm to 2300 mm, and 1500 mm in this embodiment. This allows the catheter 1 to reach the arteries of the lower extremities.
- the effective length of the shaft 2 is the length of a portion that can be inserted into a blood vessel, a sheath, or the like. In this embodiment, the effective length is the length from the tip of the kink protector 4 to the tip of the shaft 2 .
- the effective length of the shaft 2 is 1200 mm or more when introduced from the arm artery, 650 mm or more when introduced from the femoral artery, and 300 mm or more when introduced from the distal part of the dorsalis pedis artery or posterior tibial artery. is preferred.
- the shaft 2 is composed of a plurality of layers, including an inner layer 10 forming an inner surface 11 of the lumen 5, a reinforcing member 20 arranged radially outside the inner layer 10, and a reinforcing member 20 arranged radially outside the reinforcing member 20. and an outer layer 40 formed radially outside the inner layer 10 , the reinforcing body 20 and the markers 30 .
- the radially outer side is the side away from the axial center of the shaft 2 .
- the inner diameter of the inner layer 10 is not particularly limited, it is preferably 0.2 mm to 1.2 mm, more preferably 0.4 mm to 1.1 mm, still more preferably 0.4 mm to 0.55 mm.
- the inner and outer diameters of the inner layer 10 are smaller than the portions adjacent to the shaft 2 in the axial direction X at the positions covered with the markers 30 .
- the inner layer 10 has a lumen 5 formed therein.
- the constituent material of the inner layer 10 can be a thermoplastic resin, a thermosetting resin, or the like, and is preferably a fluorine-based resin such as polytetrafluoroethylene (PTFE) or a low-friction material such as high-density polyethylene (HDPE).
- PTFE polytetrafluoroethylene
- HDPE high-density polyethylene
- a resin, a polyamide elastomer, a polyester, a polyester elastomer, or the like may be used.
- the reinforcing body 20 is formed by braiding a plurality of reinforcing wires 21 into a tubular shape around the outer circumference of the inner layer 10 so as to have gaps.
- the reinforcing body 20 is formed with a small diameter portion 22 having a locally small outer diameter for arranging the marker 30 .
- the length of the small diameter portion 22 in the axial direction X is preferably equal to or greater than the length of the marker 30 in the axial direction X so that the marker 30 can be accommodated.
- the reinforcing body 20 may be wound with the reinforcing wire 21 while changing the winding direction such as horizontal winding in the same direction, right winding or left winding, and the winding pitch, the inter-grid distance, the inclination angle with respect to the circumferential direction, etc.
- the configuration is not particularly limited.
- one reinforcing wire 21 may be coiled in one direction and formed into a tubular shape with a gap.
- the reinforcing body 20 may be arranged all over the shaft 2 in the axial direction X, or may be arranged only partially.
- the distal end of the reinforcing body 20 is located near the distal end of the shaft 2 and slightly closer to the proximal side than the distal end of the shaft 2 .
- the proximal end of the reinforcing body 20 is located in the vicinity of the proximal end of the shaft 2 and slightly to the distal side of the proximal end of the shaft 2 . Since the portion of the distal end of the shaft 2 where the reinforcing member 20 is not arranged has a high degree of flexibility, it is easy to change the bending direction along the guidewire and reduce the burden on the living tissue in contact.
- the wire diameter (diameter) of the reinforcing wire 21 is not particularly limited, but is preferably 0.03 mm to 0.08 mm, more preferably 0.03 mm to 0.06 mm, still more preferably 0.04 mm to 0.06 mm. Yes, and is 0.03 mm in this embodiment.
- the reinforcing wire 21 can be made of stainless steel, platinum (Pt), tungsten (W) or other metal wire, resin fiber, carbon fiber, glass fiber, or the like. A round wire, an elliptical wire, or a flat wire may be used. Each reinforcing wire 21 may be used as one wire for braiding, and a bundle of two or more reinforcing wires 21 may be used as one braiding wire. may be used as one line.
- the marker 30 is an X-ray opaque (X-ray contrast) tubular body that enters the small diameter portion 22 from the outside in the radial direction.
- X-ray opaque (X-ray contrast) tubular body that enters the small diameter portion 22 from the outside in the radial direction.
- the tubular body is crimped while being sandwiched from two or more locations facing each other on the radially outer side, and crimping is repeatedly performed while gradually shifting the crimped positions in the circumferential direction, thereby reducing the diameter of the entire marker 30. be done.
- a plurality of concave portions 31 and a plurality of convex portions 32 are alternately formed on the outer peripheral surface of the tubular body. Therefore, the cross-sectional shape of the outer peripheral surface of the marker 30 in the cross section perpendicular to the axial direction X of the shaft 2 is non-circular, preferably substantially polygonal.
- the recess 31 is formed in a groove shape extending in the axial direction X of the shaft 2 .
- the convex portion 32 is formed in a beam shape extending in the axial direction X of the shaft 2 .
- the concave portions 31 and the convex portions 32 are arranged substantially evenly in the circumferential direction of the marker 30 .
- the number of concave portions 31 and convex portions 32 is not particularly limited, but the greater the number, the closer the cross-sectional shape of the marker 30 is to a circular shape.
- the concave portion 31 does not have to be groove-shaped.
- the convex part 32 may not be beam-shaped.
- the concave portions 31 and the convex portions 32 may be randomly arranged.
- the form of the marker 30 is not limited to this.
- the shape of the marker 30 before crimping may be C-shaped in a cross section orthogonal to the axial direction X.
- each marker 30 may be a coil of radiographic metal wire, for example of circular, oval, square or rectangular cross-section.
- the number of markers 30 is one or more, but may be two, three, or four or more.
- the thickness of the marker 30 is not particularly limited, it is preferably 0.02 mm to 0.1 mm, more preferably 0.03 mm to 0.08 mm, still more preferably 0.03 mm to 0.04 mm. is 0.03 mm.
- the length of the marker 30 in the axial direction is not particularly limited, it is preferably 0.5 mm to 5 mm, more preferably 0.7 mm to 3 mm, still more preferably 0.9 mm to 2 mm.
- the constituent material of the marker 30 is preferably a material kneaded with an X-ray contrast agent such as metal powder of platinum, gold, silver, tungsten, iridium or alloys thereof, barium sulfate, bismuth oxide, or a coupling compound thereof.
- an X-ray contrast agent such as metal powder of platinum, gold, silver, tungsten, iridium or alloys thereof, barium sulfate, bismuth oxide, or a coupling compound thereof.
- a metal coil or contrasting solder may be used.
- the outer layer 40 is a tubular body arranged around the inner layer 10 , the reinforcing body 20 and the marker 30 .
- the outer diameter of the outer layer 40 is not particularly limited, but is preferably 0.6 mm to 1.6 mm, more preferably 0.65 mm to 1.4 mm, still more preferably 0.65 mm to 0.9 mm, In this embodiment, it is 0.75 mm on the tip side of the outer layer 40 and 0.75 mm on the base side of the outer layer 40 .
- the constituent material of the outer layer 40 is, for example, polyolefin (eg, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, Polyamides, polyester elastomers, polyamide elastomers, polyurethanes, polyurethane elastomers, polyimides, fluorine resins and other polymeric materials, thermoplastic resins such as mixtures thereof, and thermosetting resins such as epoxy resins can be used.
- the outer layer 40 may be mixed with an X-ray opaque substance, and the constituent material of the outer layer 40 may be the same as the constituent material of the inner layer 10 .
- the shaft 2 includes, in the axial direction X, a plurality of marker placement portions 51 in which the markers 30 are placed and a plurality of marker absent portions 52 in which the markers 30 are not placed.
- the marker-placed portions 51 and the marker-absent portions 52 are alternately arranged in the axial direction X.
- the outer diameter D6 of the marker placement portion 51 is the same as or substantially the same as the outer diameter D7 of the marker absent portion 52 . It should be noted that the fact that the outer diameter is substantially the same means that there is a slight difference in shape on the outer peripheral surface due to differences in configuration, such as whether the marker 30 or the reinforcing member 20 is provided inside the outer peripheral surface. Also, when it can be judged that the outer diameters are substantially the same as a whole, it means that the outer diameters are substantially the same.
- the inner diameter D1 of the lumen 5 of each marker placement portion 51 is smaller than the inner diameter D2 of the lumen 5 of the marker absent portion 52 . Accordingly, by arranging the markers 30 , it is possible to prevent the strength of the shaft 2 from being lowered due to the inner layer 10 becoming thinner than necessary. In addition, since the difference between the inner diameter D1 of the lumen 5 of the marker placement portion 51 and the outer diameter of the guidewire is small, it is easy to hold (support) the guidewire. In addition, since the marker placement portion 51 is provided only in a portion of the catheter 1 in the axial direction X, the sliding resistance of the catheter 1 as a whole with respect to the guide wire can be reduced.
- Each marker placement portion 51 has, on its inner peripheral surface, a constant inner diameter portion 55 having a substantially constant inner diameter D1, a tip tapered portion 56 having an inner diameter that decreases toward the distal end from the constant inner diameter portion 55, and a constant inner diameter portion. and a proximal tapered portion 57 having an inner diameter that decreases from 55 in the proximal direction. Since each marker placement portion 51 has a distal tapered portion 56 and a proximal tapered portion 57 , it is possible to prevent the guide wire passing through the lumen 5 from getting caught in the marker placement portion 51 .
- the length L of the marker placement portion 51 in the axial direction X is not particularly limited as long as it is longer than the axial length of the marker 30, but is, for example, 0.5 mm or more, preferably 0.7 mm to 3 mm.
- the inner diameter D1 of the lumen 5 of the marker placement portion 51 is not particularly limited, it is preferably 0.38 mm to 0.55 mm.
- the inner diameter D2 of the lumen 5 of the marker absent portion 52 is not particularly limited, but is preferably 0.45 mm to 0.60 mm.
- the outer diameter of the catheter is not particularly limited, but is preferably 0.70 mm to 0.90 mm, and the difference between the inner diameter D2 of the lumen 5 of the marker-free portion 52 and the inner diameter D1 of the lumen 5 of the marker-placed portion 51 is not particularly limited. is preferably 0.03 mm to 0.06 mm.
- the outer diameter D3 of the marker 30 (the maximum outer diameter when the outer diameter D3 of the marker 30 differs depending on the position) is the outer diameter D4 of the reinforcing body 20 arranged in the adjacent marker absent portion 52 (the outer diameter D4 of the reinforcing body 20 is less than or equal to the maximum outer diameter), preferably less than the outer diameter D4. Accordingly, by arranging the markers 30 , it is possible to prevent the outer layer 40 on the radially outer side of the markers 30 from becoming unnecessarily thin and reducing the strength of the shaft 2 . Furthermore, it is possible to prevent the outer diameter D ⁇ b>6 of the marker-placed portion 51 from becoming larger than the outer diameter D ⁇ b>7 of the marker-absent portion 52 .
- the outer diameter D5 of the small diameter portion 22 of the reinforcing body 20 arranged in the marker placement portion 51 is smaller than the outer diameter D4 of the reinforcing body 20 arranged in the marker absent portion 52 .
- the length of the reinforcing member 20 in the axial direction X is longer than the length of the marker 30 in the axial direction X, when the marker 30 is crimped to reduce its diameter and is placed, the marker 30 pushes the reinforcing member 20 to contract.
- the diameter of the reinforcing body 20 is also reduced at a position away from the marker 30 . Therefore, when the marker 30 is placed, the diameter of the reinforcing body 20 changes smoothly in the vicinity of the marker 30, and the inner peripheral surface of the lumen 5 including the distal tapered portion 56, the constant inner diameter portion 55, and the proximal tapered portion 57 is changed. is formed smoothly. Therefore, it is possible to prevent the guide wire passing through the lumen 5 from being caught in the marker placement portion 51 .
- the base end of the shaft 2 of the hub 3 is liquid-tightly fixed with an adhesive, heat-sealing, or a fastener (not shown).
- the hub 3 functions as an insertion port for a guide wire and medical instruments into the lumen 5, an injection port for a drug solution, an embolic substance, a contrast medium, etc., into the lumen 5, and the like, and also serves as a grip when operating the catheter 1. also functions as
- the material constituting the hub 3 is not particularly limited, but thermoplastic resins such as polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer can be suitably used.
- the anti-kink protector 4 is made of an elastic material that surrounds the circumference of the shaft 2 and suppresses kinking of the shaft 2 at the connecting portion between the shaft 2 and the hub 3 .
- natural rubber, silicone resin, polyester elastomer, polyamide elastomer, polyurethane elastomer, etc. can be suitably used as the constituent material of the kink resistant protector 4 .
- the catheter 1 includes the shaft 2 having the lumen 5 communicating from the distal end to the proximal end. and a radiopaque marker 30 positioned at least one location in the axial direction X of the shaft 2 , the marker 30 being larger in diameter of the shaft 2 than the reinforcement 20 .
- the inner diameter D1 of the lumen 5 of the marker-placed portion 51 of the shaft 2, which is arranged on the direction outer side and in which the marker 30 is arranged, is smaller than the inner diameter D2 of the marker-free portion 52 of the shaft 2, in which the marker 30 is not arranged.
- the outer diameter D6 of the portion 51 is the same or substantially the same as the outer diameter D7 of the marker absent portion 52 . “Substantially the same” means that the outer diameter D6 of the marker-placed portion 51 and the outer diameter D7 of the marker-absent portion 52 are not only numerically the same but also practically the same.
- the difference between the outer diameter D6 of the marker-placed portion 51 and the outer diameter D7 of the marker-absent portion 52 is 0 to 0.1 mm, preferably 0 to 0.05 mm, more preferably 0.01 to 0.03 mm.
- the outer diameter measurement method is not particularly limited, but the outer diameter and outer diameter difference are compared by measuring the outer diameter at the middle between the tip and the proximal end of the marker with a laser outer diameter device.
- the catheter 1 configured as described above can improve retention of the guide wire inserted into the lumen 5 by the marker placement portion 51 having a small inner diameter. Moreover, since the inner diameter D2 of the marker-absent portion 52 is larger than the inner diameter D1 of the marker-placed portion 51, the sliding resistance of the catheter 1 as a whole with respect to the guide wire can be reduced. In addition, since the outer diameter D6 of the marker-placed portion 51 is substantially the same as the outer diameter D7 of the marker-absent portion 52, the insertability of the catheter 1 into the body lumen can be improved. Therefore, the catheter 1 can improve the ease of inserting the catheter 1 into the body lumen while maintaining the guide wire holdability and slidability.
- the outer diameter D3 of the marker 30 may be equal to or less than the outer diameter D4 of the reinforcing body 20.
- the outer diameter D6 of the marker-placed portion 51 is substantially the same as the outer diameter D7 of the marker-absent portion 52, the outer layer 40 covering the marker 30 is prevented from becoming thinner than necessary and the strength of the shaft 2 is reduced. can.
- the marker 30 is arranged on the small diameter portion 22 of the reinforcing member 20, the unintended movement of the marker 30 in the axial direction X can be effectively suppressed by the reinforcing member 20. .
- the shape of the outer peripheral surface of the marker 30 may be polygonal in a cross section perpendicular to the axial direction X of the shaft 2 . As a result, the contact area between the marker 30 and the outer layer 40 covering the outer peripheral surface of the marker 30 is increased, and the markers are stably joined, thereby suppressing a decrease in the strength of the shaft 2 .
- the outer diameter of the shaft 2 is 0.6 mm or more and 0.9 mm or less
- the inner diameter D1 of the lumen 5 of the marker placement portion 51 is 0.38 mm or more and 0.55 mm or less
- the lumen 5 of the marker absent portion 52 is 0.38 mm or more and 0.55 mm or less
- the inner diameter D2 of may be 0.45 mm or more and 0.60 mm or less.
- a plurality of marker arrangement portions 51 are provided, but only one may be provided.
- the outer diameter of the marker-placed portion may be different from the outer diameter of the marker-absent portion.
- the inner diameters D1 of the lumens 5 of the plurality of marker placement portions 51 may be the same or different.
- the catheter 1 may also be inserted into bile ducts, trachea, esophagus, urethra, or other biological lumens or body cavities and used for treatment, diagnosis, and the like.
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Abstract
Provided is a catheter capable of improving the catheter insertability into a lumen in vivo while maintaining retention and sliding properties of a guidewire. A catheter (1) provided with a shaft (2) having a lumen (5) extending from the tip to the base, wherein: the shaft (2) has a reinforcing body (20) provided with a plurality of tubularly braided reinforcing wires (21) and a radiopaque marker (30) placed at least one position in the axial direction (X) of the shaft (2); the marker (30) is placed radially outward from the reinforcing body (20) on the shaft (2); the inner diameter (D1) of the lumen (5) in the marker placement section (51) of the shaft (2) where the marker (30) is placed is smaller than the inner diameter (D2) in the marker absence section (52) of the shaft (2) where the marker (30) is not placed; and the outer diameter (D6) of the marker placement section (51) is substantially identical with the outer diameter (D7) of the marker absence section (52).
Description
本発明は、血管等の管腔内で使用されるカテーテルに関する。
The present invention relates to catheters used in lumens such as blood vessels.
近年、外科的侵襲が非常に低いという理由から、カテーテルを用いた血管等の管腔内の治療が盛んに行われている。例えば、体内の複雑に分岐した血管へ選択的に導入して使用されるカテーテルは、一般的に、血管へあらかじめ導入されるガイドワイヤに沿って押し込まれて、治療用の薬剤や診断用の造影剤等をルーメンを介して流通させることができる。また、カテーテルは、管腔内での位置を体外から認識できるように、X線不透過性のマーカーがシャフトに配置される(例えば特許文献1を参照)。
In recent years, intraluminal treatments such as blood vessels using catheters have been actively performed because the surgical invasiveness is very low. For example, catheters that are used to selectively introduce into complex branching blood vessels in the body are generally pushed along a guide wire that has been previously introduced into the blood vessel to deliver therapeutic drugs and diagnostic imaging. Agents and the like can be distributed through the lumen. In addition, the catheter has a radiopaque marker placed on the shaft so that the position within the lumen can be recognized from outside the body (see, for example, Patent Document 1).
特許文献1には、内層に巻き付けた補強体の一部を変形させて設けた小径部にマーカーを設けることでルーメンの内径とカテーテルの外径が一定であるカテーテルが記載されている。
Patent Document 1 describes a catheter in which the inner diameter of the lumen and the outer diameter of the catheter are constant by providing a marker on the small-diameter portion formed by partially deforming the reinforcing body wound around the inner layer.
特許文献1に記載のカテーテルは、マーカーが配置される部位の内径が、マーカーの無い分の内径と同一であるため、ガイドワイヤとカテーテル内面の摺動性を保つため、カテーテルの内径が大きいため、ガイドワイヤ外径との差が大きくガイドワイヤを保持(サポート)が不十分である。このため、生体管腔へのカテーテルの挿入性が低下する可能性がある。
In the catheter described in Patent Document 1, since the inner diameter of the portion where the marker is placed is the same as the inner diameter of the portion without the marker, the inner diameter of the catheter is large in order to maintain the slidability between the guide wire and the inner surface of the catheter. , the difference between the outer diameter of the guidewire is large and the guidewire is not sufficiently supported. Therefore, there is a possibility that the ease of inserting the catheter into the body lumen is reduced.
本発明は、上述した課題を解決するためになされたものであり、ガイドワイヤの保持性および摺動性を維持しつつ、カテーテルの生体管腔への挿入性を向上できるカテーテルを提供することを目的とする。
SUMMARY OF THE INVENTION The present invention has been made in order to solve the above-described problems, and it is an object of the present invention to provide a catheter that can improve the insertability of the catheter into a biological lumen while maintaining the holdability and slidability of the guidewire. aim.
上記目的を達成するカテーテルは、先端から基端まで連通するルーメンを有するシャフトを備えたカテーテルであって、前記シャフトは、管状に編組された複数の補強線を備える補強体と、前記シャフトの軸心方向の少なくとも1か所に配置されるX線不透過性のマーカーと、を有し、前記マーカーは、前記補強体よりも前記シャフトの径方向外側に配置され、前記シャフトの前記マーカーが配置されたマーカー配置部のルーメンの内径は、前記シャフトの前記マーカーが配置されていないマーカー不在部のルーメンの内径よりも小さく、前記マーカー配置部の外径は、前記マーカー不在部の外径と実質同一である。
A catheter for achieving the above object is a catheter comprising a shaft having a lumen communicating from a distal end to a proximal end, the shaft comprising a reinforcing body having a plurality of tubularly braided reinforcing wires, and an axis of the shaft. a radiopaque marker positioned in at least one central location, said marker positioned radially outward of said shaft relative to said stiffener, said marker positioned on said shaft. The inner diameter of the lumen of the marker-placed portion of the shaft is smaller than the inner diameter of the lumen of the marker-free portion of the shaft where the marker is not placed, and the outer diameter of the marker-placed portion is substantially equal to the outer diameter of the marker-free portion. are identical.
上記のように構成したカテーテルは、内径の小さいマーカー配置部により、ルーメンに挿入されるガイドワイヤを効果的に保持できる。また、マーカー不在部のルーメンの内径がマーカー配置部のルーメンの内径よりも大きいため、カテーテル全体としてのガイドワイヤとの摺動抵抗を低減できる。また、マーカー配置部の外径は、マーカー不在部の外径と実質同一であるため、カテーテルの生体管腔への挿入性を向上できる。
The catheter configured as described above can effectively hold the guidewire inserted into the lumen by the marker placement portion with a small inner diameter. In addition, since the inner diameter of the lumen in the marker-absent portion is larger than the inner diameter of the lumen in the marker-placed portion, the sliding resistance of the catheter as a whole against the guidewire can be reduced. In addition, since the outer diameter of the marker-placed portion is substantially the same as the outer diameter of the marker-absent portion, it is possible to improve the insertability of the catheter into the biological lumen.
前記マーカーの外径は、前記補強体の外径以下であってもよい。これにより、マーカー配置部の外径を、マーカー不在部の外径と実質同一としても、シャフトのマーカーを覆う層が必要以上に薄くなることを抑制できるため、シャフトの強度が低下することを抑制できる。また、マーカーは、補強体の部分的に縮径した部位に完全に入り込むように配置されることになるため、マーカーの軸心方向への意図しない移動を補強体により効果的に抑制できる。
The outer diameter of the marker may be equal to or less than the outer diameter of the reinforcing body. As a result, even if the outer diameter of the portion where the marker is placed is substantially the same as the outer diameter of the portion where the marker is absent, it is possible to prevent the layer that covers the marker on the shaft from becoming thinner than necessary, thereby suppressing a decrease in the strength of the shaft. can. In addition, since the marker is arranged so as to completely enter the portion of the reinforcing body whose diameter is partially reduced, the reinforcing body can effectively suppress unintended movement of the marker in the axial direction.
前記マーカーの外周面の形状は、前記シャフトの軸心方向と直交する断面において略多角形であってもよい。これにより、マーカーとその外周面を覆う部材との接触面積が増加し、安定して接合されて、シャフトの強度低下を抑制できる。
The shape of the outer peripheral surface of the marker may be substantially polygonal in a cross section perpendicular to the axial direction of the shaft. As a result, the contact area between the marker and the member covering the outer peripheral surface of the marker is increased, the joint is stably joined, and the strength reduction of the shaft can be suppressed.
前記シャフトの外径は、0.5mm以上0.9mm以下であり、前記マーカー配置部のルーメンの内径は、0.38mm以上0.55mm以下であり、前記マーカー不在部のルーメンの内径は、0.45mm以上0.6mm以下であってもよい。これにより、ガイドワイヤの保持性および摺動性を維持しつつ、カテーテルの生体管腔への挿入性を向上できるカテーテルを、適切な寸法で実現できる。
The outer diameter of the shaft is 0.5 mm or more and 0.9 mm or less, the inner diameter of the lumen of the marker placement portion is 0.38 mm or more and 0.55 mm or less, and the inner diameter of the lumen of the marker absent portion is 0. .45 mm or more and 0.6 mm or less may be used. As a result, it is possible to realize a catheter with appropriate dimensions that can improve the insertability of the catheter into a biological lumen while maintaining the guidewire holdability and slidability.
以下、図面を参照して、本発明の実施の形態を説明する。なお、図面の寸法は、説明の都合上、誇張されて実際の寸法とは異なる場合がある。また、本明細書及び図面において、実質的に同一の機能構成を有する構成要素については、同一の符号を付することにより重複説明を省略する。本明細書において、カテーテルの生体管腔に挿入する側を「先端側」、操作する側を「基端側」と称することとする。また、本明細書において、範囲を示す「X~Y」は、XおよびYを含み、「X以上Y以下」を意味する。
Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensions in the drawings may be exaggerated for convenience of explanation and may differ from the actual dimensions. Further, in the present specification and drawings, constituent elements having substantially the same functional configuration are denoted by the same reference numerals, thereby omitting redundant description. In this specification, the side of the catheter that is inserted into the biological lumen is called the "distal side", and the side that is operated is called the "proximal side". Further, in this specification, the range "X to Y" includes X and Y and means "X or more and Y or less".
本実施形態に係るカテーテル1は、腕の橈骨動脈、足の大腿動脈あるいは下肢末梢動脈から血管内に導入されて下肢の動脈内まで挿入され、治療や診断等を行うために用いられる。カテーテル1は、例えばサポートカテーテルであるが、他の用途のデバイスであってもよい。下肢の動脈とは、大動脈腸骨動脈分岐部近傍及びより末梢側の動脈である。カテーテル1は、図1に示すように、長尺なシャフト2と、シャフト2の基端に連結されるハブ3と、シャフト2およびハブ3の連結部位に設けられる耐キンクプロテクタ4とを有している。
The catheter 1 according to this embodiment is introduced into a blood vessel from the radial artery of the arm, the femoral artery of the leg, or the peripheral artery of the lower limb, is inserted into the artery of the lower limb, and is used for treatment, diagnosis, and the like. Catheter 1 is, for example, a support catheter, but may be a device for other uses. Arteries of the lower extremities are arteries near and more distal to the aortoiliac bifurcation. As shown in FIG. 1, the catheter 1 has an elongated shaft 2, a hub 3 connected to the proximal end of the shaft 2, and an anti-kink protector 4 provided at the joint between the shaft 2 and the hub 3. ing.
シャフト2は、図1~4に示すように、可撓性を有する管状の部材であり、基端から先端にかけて内部にルーメン5が形成されている。ルーメン5は、カテーテル1の血管への挿入時に、ガイドワイヤが挿通される。また、ルーメン5は、薬液や塞栓物質、造影剤、医療器具等の通路として用いることもできる。
As shown in FIGS. 1 to 4, the shaft 2 is a tubular member having flexibility, and a lumen 5 is formed inside from the proximal end to the distal end. A guide wire is passed through the lumen 5 when the catheter 1 is inserted into the blood vessel. The lumen 5 can also be used as a passageway for liquid medicines, embolic substances, contrast media, medical instruments, and the like.
シャフト2の有効長は、特に限定されないが、好ましくは200mm~2600mmであり、より好ましくは400mm~2300mm、さらに好ましくは600mm~2300mmであり、本実施形態では1500mmである。これにより、カテーテル1は、下肢の動脈へ到達できる。なお、シャフト2の有効長は、血管やシース等の内部へ挿入可能な部位の長さである。本実施形態において、有効長は、耐キンクプロテクタ4の最先端からシャフト2の最先端までの長さである。シャフト2の有効長は、腕の動脈から導入する場合は1200mm以上、大腿動脈から導入する場合は、650mm以上、足背動脈や後脛骨動脈の遠位部から導入する場合は、300mm以上であることが好ましい。
Although the effective length of the shaft 2 is not particularly limited, it is preferably 200 mm to 2600 mm, more preferably 400 mm to 2300 mm, still more preferably 600 mm to 2300 mm, and 1500 mm in this embodiment. This allows the catheter 1 to reach the arteries of the lower extremities. The effective length of the shaft 2 is the length of a portion that can be inserted into a blood vessel, a sheath, or the like. In this embodiment, the effective length is the length from the tip of the kink protector 4 to the tip of the shaft 2 . The effective length of the shaft 2 is 1200 mm or more when introduced from the arm artery, 650 mm or more when introduced from the femoral artery, and 300 mm or more when introduced from the distal part of the dorsalis pedis artery or posterior tibial artery. is preferred.
シャフト2は、複数の層で構成されており、ルーメン5の内表面11を形成する内層10と、内層10の径方向外側に配置される補強体20と、補強体20の径方向外側に配置される複数のマーカー30と、内層10、補強体20およびマーカー30の径方向外側に形成される外層40とを備えている。径方向外側とは、シャフト2の軸中心から離れる側である。
The shaft 2 is composed of a plurality of layers, including an inner layer 10 forming an inner surface 11 of the lumen 5, a reinforcing member 20 arranged radially outside the inner layer 10, and a reinforcing member 20 arranged radially outside the reinforcing member 20. and an outer layer 40 formed radially outside the inner layer 10 , the reinforcing body 20 and the markers 30 . The radially outer side is the side away from the axial center of the shaft 2 .
内層10の内径は、特に限定されないが、好ましくは0.2mm~1.2mmであり、より好ましくは0.4mm~1.1mm、さらに好ましくは0.4mm~0.55mmである。内層10の内径および外径は、マーカー30に覆われる位置において、シャフト2の軸心方向Xに隣接する部位よりも小さくなっている。
Although the inner diameter of the inner layer 10 is not particularly limited, it is preferably 0.2 mm to 1.2 mm, more preferably 0.4 mm to 1.1 mm, still more preferably 0.4 mm to 0.55 mm. The inner and outer diameters of the inner layer 10 are smaller than the portions adjacent to the shaft 2 in the axial direction X at the positions covered with the markers 30 .
内層10は、内部にルーメン5が形成されている。内層10の構成材料は、熱可塑性樹脂や熱硬化性樹脂等を適用でき、ポリテトラフルオロエチレン(PTFE)等のフッ素系樹脂、高密度ポリエチレン(HDPE)等の低摩擦材料等が好ましいが、ポリアミド樹脂、ポリアミドエラストマーあるいはポリエステル、ポリエステルエラストマーなどでもよい。
The inner layer 10 has a lumen 5 formed therein. The constituent material of the inner layer 10 can be a thermoplastic resin, a thermosetting resin, or the like, and is preferably a fluorine-based resin such as polytetrafluoroethylene (PTFE) or a low-friction material such as high-density polyethylene (HDPE). A resin, a polyamide elastomer, a polyester, a polyester elastomer, or the like may be used.
補強体20は、内層10の外周囲に、複数の補強線21を、隙間を有するように管状に編組して形成される。補強体20は、マーカー30を配置するために、局所的に外径が小さい小径部22が形成される。小径部22の軸心方向Xの長さは、マーカー30を収容できるように、マーカー30の軸心方向Xの長さ以上であることが好ましい。補強体20は、同一方向の横巻きや、右巻き・左巻き等、巻き方向を変えながら補強線21を巻きつけてもよく、また、巻きピッチ、格子間距離、周方向に対する傾斜角度等を位置によって変更してもよく、構成は特に限定されない。例えば1本の補強線21を一方向にコイル状に巻いて、隙間を有するように筒状に形成されもよい。
The reinforcing body 20 is formed by braiding a plurality of reinforcing wires 21 into a tubular shape around the outer circumference of the inner layer 10 so as to have gaps. The reinforcing body 20 is formed with a small diameter portion 22 having a locally small outer diameter for arranging the marker 30 . The length of the small diameter portion 22 in the axial direction X is preferably equal to or greater than the length of the marker 30 in the axial direction X so that the marker 30 can be accommodated. The reinforcing body 20 may be wound with the reinforcing wire 21 while changing the winding direction such as horizontal winding in the same direction, right winding or left winding, and the winding pitch, the inter-grid distance, the inclination angle with respect to the circumferential direction, etc. The configuration is not particularly limited. For example, one reinforcing wire 21 may be coiled in one direction and formed into a tubular shape with a gap.
補強体20は、シャフト2の軸心方向Xの全体に配置されてもよいが、一部にのみ配置されてもよい。本実施形態において、補強体20の先端は、シャフト2の先端の近傍であって、シャフト2の先端よりも多少基端側に配置されている。補強体20の基端は、シャフト2の基端の近傍であって、シャフト2の基端よりも多少先端側に配置されている。シャフト2の先端部の補強体20が配置されない部位は、高い柔軟性を有するため、ガイドワイヤに沿って湾曲方向を変更することが容易であり、かつ接触する生体組織の負担を低減できる。
The reinforcing body 20 may be arranged all over the shaft 2 in the axial direction X, or may be arranged only partially. In this embodiment, the distal end of the reinforcing body 20 is located near the distal end of the shaft 2 and slightly closer to the proximal side than the distal end of the shaft 2 . The proximal end of the reinforcing body 20 is located in the vicinity of the proximal end of the shaft 2 and slightly to the distal side of the proximal end of the shaft 2 . Since the portion of the distal end of the shaft 2 where the reinforcing member 20 is not arranged has a high degree of flexibility, it is easy to change the bending direction along the guidewire and reduce the burden on the living tissue in contact.
補強線21の線径(直径)は、特に限定されないが、好ましくは0.03mm~0.08mmであり、より好ましくは0.03mm~0.06mm、さらに好ましくは0.04mm~0.06mmであり、本実施形態では0.03mmである。
The wire diameter (diameter) of the reinforcing wire 21 is not particularly limited, but is preferably 0.03 mm to 0.08 mm, more preferably 0.03 mm to 0.06 mm, still more preferably 0.04 mm to 0.06 mm. Yes, and is 0.03 mm in this embodiment.
補強線21は、ステンレス鋼、白金(Pt)・タングステン(W)等の金属線、樹脂繊維、炭素繊維、ガラス繊維等を適用でき、または、これらの補強線21を複数併用してもよく、丸線、楕円線、平線でもよく、補強線21は1本毎に網組用の1つの線として使用されてもよく、2本以上の補強線21を束ねたものが網組用の1つの線として使用されてもよい。
The reinforcing wire 21 can be made of stainless steel, platinum (Pt), tungsten (W) or other metal wire, resin fiber, carbon fiber, glass fiber, or the like. A round wire, an elliptical wire, or a flat wire may be used. Each reinforcing wire 21 may be used as one wire for braiding, and a bundle of two or more reinforcing wires 21 may be used as one braiding wire. may be used as one line.
マーカー30は、小径部22に径方向外側から入り込むX線不透過性(X線造影性)の管体である。マーカー30を配置する際には、外径が軸心方向Xに沿って略一定の内層10の外周囲に、外径が軸心方向Xに沿って略一定の補強体20を配置した後に、内層10および補強体20を囲むように、X線不透過物質を含む材料により形成される管体を配置する。この後、管体を、径方向外側の対向する2か所以上から挟んでかしめて、かしめる位置を周方向に少しずつずらしつつ繰り返しかしめることで、マーカー30の全体を縮径させて形成される。これにより、管体は、外周面に複数の凹部31および複数の凸部32が交互に形成される。したがって、シャフト2の軸心方向Xと直交する断面におけるマーカー30の外周面の断面形状は、非円形であり、好ましくは略多角形である。本実施形態において、凹部31は、シャフト2の軸心方向Xへ延在して溝状に形成される。凸部32は、シャフト2の軸心方向Xへ延在して梁状に形成される。凹部31および凸部32は、マーカー30の周方向に略均等に並んで配置される。凹部31および凸部32の数は、特に限定されないが、多いほどマーカー30の断面形状が円形に近づく。なお、凹部31は、溝状でなくてもよい。また、凸部32は、梁状でなくてもよい。例えば、凹部31および凸部32が、ランダムに配置されてもよい。管体を縮径させてマーカー30が形成されると、マーカー30が配置される補強体20は、マーカー30と共に縮径する。
The marker 30 is an X-ray opaque (X-ray contrast) tubular body that enters the small diameter portion 22 from the outside in the radial direction. When arranging the marker 30, after placing the reinforcing body 20 having a substantially constant outer diameter along the axial direction X around the outer periphery of the inner layer 10 having a substantially constant outer diameter along the axial direction X, A tubular body made of a material containing an X-ray opaque substance is arranged so as to surround the inner layer 10 and the reinforcing body 20 . After that, the tubular body is crimped while being sandwiched from two or more locations facing each other on the radially outer side, and crimping is repeatedly performed while gradually shifting the crimped positions in the circumferential direction, thereby reducing the diameter of the entire marker 30. be done. As a result, a plurality of concave portions 31 and a plurality of convex portions 32 are alternately formed on the outer peripheral surface of the tubular body. Therefore, the cross-sectional shape of the outer peripheral surface of the marker 30 in the cross section perpendicular to the axial direction X of the shaft 2 is non-circular, preferably substantially polygonal. In this embodiment, the recess 31 is formed in a groove shape extending in the axial direction X of the shaft 2 . The convex portion 32 is formed in a beam shape extending in the axial direction X of the shaft 2 . The concave portions 31 and the convex portions 32 are arranged substantially evenly in the circumferential direction of the marker 30 . The number of concave portions 31 and convex portions 32 is not particularly limited, but the greater the number, the closer the cross-sectional shape of the marker 30 is to a circular shape. Note that the concave portion 31 does not have to be groove-shaped. Moreover, the convex part 32 may not be beam-shaped. For example, the concave portions 31 and the convex portions 32 may be randomly arranged. When the tubular body is contracted to form the marker 30 , the reinforcing body 20 on which the marker 30 is arranged is contracted together with the marker 30 .
なお、マーカー30の形態は、これに限定されない。例えば、かしめる前のマーカー30の形状は、軸心方向Xと直交する断面においてC字形状であってもよい。または、各々のマーカー30は、例えば断面が円形、楕円形、正方形あるいは長方形等のX線造影性金属のワイヤをコイル巻きにしたものであってもよい。マーカー30の数は、1つ以上であるが、2つや3つであってもよく、4つ以上であってもよい。
The form of the marker 30 is not limited to this. For example, the shape of the marker 30 before crimping may be C-shaped in a cross section orthogonal to the axial direction X. Alternatively, each marker 30 may be a coil of radiographic metal wire, for example of circular, oval, square or rectangular cross-section. The number of markers 30 is one or more, but may be two, three, or four or more.
マーカー30の厚みは、特に限定されないが、好ましくは0.02mm~0.1mmであり、より好ましくは0.03mm~0.08mm、さらに好ましくは0.03mm~0.04mmであり、本実施形態では0.03mmである。
Although the thickness of the marker 30 is not particularly limited, it is preferably 0.02 mm to 0.1 mm, more preferably 0.03 mm to 0.08 mm, still more preferably 0.03 mm to 0.04 mm. is 0.03 mm.
マーカー30の軸方向の長さは、特に限定されないが、好ましくは0.5mm~5mmであり、より好ましくは0.7mm~3mm、さらに好ましくは0.9mm~2mmである。
Although the length of the marker 30 in the axial direction is not particularly limited, it is preferably 0.5 mm to 5 mm, more preferably 0.7 mm to 3 mm, still more preferably 0.9 mm to 2 mm.
マーカー30の構成材料は、白金、金、銀、タングステン、イリジウムまたはこれらの合金による金属粉末、硫酸バリウム、酸化ビスマス、またはそれらのカップリング化合物のようなX線造影剤を混練した材料が好適に使用できるほか、金属コイルあるいは造影性を有するハンダでもよい。
The constituent material of the marker 30 is preferably a material kneaded with an X-ray contrast agent such as metal powder of platinum, gold, silver, tungsten, iridium or alloys thereof, barium sulfate, bismuth oxide, or a coupling compound thereof. Alternatively, a metal coil or contrasting solder may be used.
外層40は、内層10、補強体20およびマーカー30の外周囲に配置される管体である。外層40の外径は、特に限定されないが、好ましくは0.6m~1.6mmであり、より好ましくは0.65mm~1.4mmであり、さらに好ましくは0.65mm~0.9mmであり、本実施形態では外層40の先端側で0.75mm、外層40の基部側で0.75mmである。
The outer layer 40 is a tubular body arranged around the inner layer 10 , the reinforcing body 20 and the marker 30 . The outer diameter of the outer layer 40 is not particularly limited, but is preferably 0.6 mm to 1.6 mm, more preferably 0.65 mm to 1.4 mm, still more preferably 0.65 mm to 0.9 mm, In this embodiment, it is 0.75 mm on the tip side of the outer layer 40 and 0.75 mm on the base side of the outer layer 40 .
外層40の構成材料は、例えば、ポリオレフィン(例えば、ポリエチレン、ポリプロピレン、ポリブテン、エチレン-プロピレン共重合体、エチレン-酢酸ビニル共重合体、アイオノマー、或いはこれら二種以上の混合物等)、ポリ塩化ビニル、ポリアミド、ポリエステルエラストマー、ポリアミドエラストマー、ポリウレタン、ポリウレタンエラストマー、ポリイミド、フッ素樹脂等の高分子材料或いはこれらの混合物等の熱可塑性樹脂、エポキシ樹脂等の熱硬化性樹脂を適用できる。外層40には、X線不透過物質を混合してもよく、外層40の構成材料は、内層10の構成材料と同じでもよい。
The constituent material of the outer layer 40 is, for example, polyolefin (eg, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, Polyamides, polyester elastomers, polyamide elastomers, polyurethanes, polyurethane elastomers, polyimides, fluorine resins and other polymeric materials, thermoplastic resins such as mixtures thereof, and thermosetting resins such as epoxy resins can be used. The outer layer 40 may be mixed with an X-ray opaque substance, and the constituent material of the outer layer 40 may be the same as the constituent material of the inner layer 10 .
シャフト2は、軸心方向Xにおいて、マーカー30が配置される複数のマーカー配置部51と、マーカー30が配置されない複数のマーカー不在部52とを備えている。マーカー配置部51およびマーカー不在部52は、軸心方向Xに交互に配置されている。マーカー配置部51の外径D6は、マーカー不在部52の外径D7と同一または実質同一である。なお、外径が実質同一とは、例えば外周面の内側にマーカー30があるか、もしくは補強体20があるかなどの構成の違い等によって外周面に微小な形状差などがある場合であっても、全体的に見て外径が略同一であると判断できる場合には、外径が実質的に同一であることを意味する。
The shaft 2 includes, in the axial direction X, a plurality of marker placement portions 51 in which the markers 30 are placed and a plurality of marker absent portions 52 in which the markers 30 are not placed. The marker-placed portions 51 and the marker-absent portions 52 are alternately arranged in the axial direction X. As shown in FIG. The outer diameter D6 of the marker placement portion 51 is the same as or substantially the same as the outer diameter D7 of the marker absent portion 52 . It should be noted that the fact that the outer diameter is substantially the same means that there is a slight difference in shape on the outer peripheral surface due to differences in configuration, such as whether the marker 30 or the reinforcing member 20 is provided inside the outer peripheral surface. Also, when it can be judged that the outer diameters are substantially the same as a whole, it means that the outer diameters are substantially the same.
各々のマーカー配置部51のルーメン5の内径D1は、マーカー不在部52のルーメン5の内径D2よりも小さい。これにより、マーカー30を配置することで、内層10が必要以上に薄くなってシャフト2の強度が低下することを抑制できる。また、マーカー配置部51のルーメン5の内径D1と、ガイドワイヤ外径との差が小さくなるので、ガイドワイヤを保持(サポート)しやすい。また、マーカー配置部51は、カテーテル1の軸心方向Xの一部にのみ設けられるため、カテーテル1全体としてのガイドワイヤとの摺動抵抗を低減できる。
The inner diameter D1 of the lumen 5 of each marker placement portion 51 is smaller than the inner diameter D2 of the lumen 5 of the marker absent portion 52 . Accordingly, by arranging the markers 30 , it is possible to prevent the strength of the shaft 2 from being lowered due to the inner layer 10 becoming thinner than necessary. In addition, since the difference between the inner diameter D1 of the lumen 5 of the marker placement portion 51 and the outer diameter of the guidewire is small, it is easy to hold (support) the guidewire. In addition, since the marker placement portion 51 is provided only in a portion of the catheter 1 in the axial direction X, the sliding resistance of the catheter 1 as a whole with respect to the guide wire can be reduced.
各々のマーカー配置部51は、内周面に、略一定の内径D1を有する内径一定部55と、内径一定部55から先端方向へ向かって減少する内径を有する先端テーパ部56と、内径一定部55から基端方向へ向かって減少する内径を有する基端テーパ部57とを備えている。各々のマーカー配置部51は、先端テーパ部56および基端テーパ部57を有することで、ルーメン5を通るガイドワイヤがマーカー配置部51に引っ掛かることを抑制できる。マーカー配置部51の軸心方向Xの長さLは、マーカー30の軸方向長さより大きければ特に限定されないが、例えば0.5mm以上であり、好ましくは0.7mm~3mmである。
Each marker placement portion 51 has, on its inner peripheral surface, a constant inner diameter portion 55 having a substantially constant inner diameter D1, a tip tapered portion 56 having an inner diameter that decreases toward the distal end from the constant inner diameter portion 55, and a constant inner diameter portion. and a proximal tapered portion 57 having an inner diameter that decreases from 55 in the proximal direction. Since each marker placement portion 51 has a distal tapered portion 56 and a proximal tapered portion 57 , it is possible to prevent the guide wire passing through the lumen 5 from getting caught in the marker placement portion 51 . The length L of the marker placement portion 51 in the axial direction X is not particularly limited as long as it is longer than the axial length of the marker 30, but is, for example, 0.5 mm or more, preferably 0.7 mm to 3 mm.
マーカー配置部51のルーメン5の内径D1は、特に限定されないが、好ましくは0.38mm~0.55mmである。マーカー不在部52のルーメン5の内径D2は、特に限定されないが、好ましくは0.45mm~0.60mmである。カテーテルの外径は、特に限定されないが、好ましくは0.70mm~0.90mmであり、マーカー不在部52のルーメン5の内径D2とマーカー配置部51のルーメン5の内径D1の差は特に限定されないが、好ましくは0.03mm~0.06mmである。
Although the inner diameter D1 of the lumen 5 of the marker placement portion 51 is not particularly limited, it is preferably 0.38 mm to 0.55 mm. The inner diameter D2 of the lumen 5 of the marker absent portion 52 is not particularly limited, but is preferably 0.45 mm to 0.60 mm. The outer diameter of the catheter is not particularly limited, but is preferably 0.70 mm to 0.90 mm, and the difference between the inner diameter D2 of the lumen 5 of the marker-free portion 52 and the inner diameter D1 of the lumen 5 of the marker-placed portion 51 is not particularly limited. is preferably 0.03 mm to 0.06 mm.
マーカー30の外径D3(マーカー30の外径D3が位置によって異なる場合は最大外径)は、隣接するマーカー不在部52に配置される補強体20の外径D4(補強体20の外径D4が位置によって異なる場合は最大外径)以下であり、好ましくは外径D4未満である。これにより、マーカー30を配置することで、マーカー30の径方向外側の外層40が必要以上に薄くなってシャフト2の強度が低下することを抑制できる。さらに、マーカー配置部51の外径D6が、マーカー不在部52の外径D7よりも大きくなることを抑制できる。
The outer diameter D3 of the marker 30 (the maximum outer diameter when the outer diameter D3 of the marker 30 differs depending on the position) is the outer diameter D4 of the reinforcing body 20 arranged in the adjacent marker absent portion 52 (the outer diameter D4 of the reinforcing body 20 is less than or equal to the maximum outer diameter), preferably less than the outer diameter D4. Accordingly, by arranging the markers 30 , it is possible to prevent the outer layer 40 on the radially outer side of the markers 30 from becoming unnecessarily thin and reducing the strength of the shaft 2 . Furthermore, it is possible to prevent the outer diameter D<b>6 of the marker-placed portion 51 from becoming larger than the outer diameter D<b>7 of the marker-absent portion 52 .
また、マーカー配置部51に配置される補強体20の小径部22の外径D5は、マーカー不在部52に配置される補強体20の外径D4よりも小さい。これにより、カテーテル1の製造時および使用時のいずれにおいても、マーカー配置部51の補強体20の径方向外側に配置されるマーカー30が、軸心方向Xへずれることを効果的に抑制できる。また、補強体20の軸心方向Xの長さは、マーカー30の軸心方向Xの長さよりも長いため、マーカー30をかしめて縮径させつつ配置する際に、マーカー30に押されて縮径する補強体20は、マーカー30から離れた位置においても縮径する。このため、マーカー30を配置する際に、マーカー30の近傍で補強体20の径が滑らかに変化し、先端テーパ部56、内径一定部55および基端テーパ部57を含むルーメン5の内周面が、滑らかに形成される。したがって、ルーメン5を通るガイドワイヤがマーカー配置部51に引っ掛かることを抑制できる。
Also, the outer diameter D5 of the small diameter portion 22 of the reinforcing body 20 arranged in the marker placement portion 51 is smaller than the outer diameter D4 of the reinforcing body 20 arranged in the marker absent portion 52 . As a result, it is possible to effectively prevent the markers 30 arranged radially outside the reinforcing member 20 of the marker arrangement portion 51 from shifting in the axial direction X both during manufacture and during use of the catheter 1 . In addition, since the length of the reinforcing member 20 in the axial direction X is longer than the length of the marker 30 in the axial direction X, when the marker 30 is crimped to reduce its diameter and is placed, the marker 30 pushes the reinforcing member 20 to contract. The diameter of the reinforcing body 20 is also reduced at a position away from the marker 30 . Therefore, when the marker 30 is placed, the diameter of the reinforcing body 20 changes smoothly in the vicinity of the marker 30, and the inner peripheral surface of the lumen 5 including the distal tapered portion 56, the constant inner diameter portion 55, and the proximal tapered portion 57 is changed. is formed smoothly. Therefore, it is possible to prevent the guide wire passing through the lumen 5 from being caught in the marker placement portion 51 .
ハブ3は、シャフト2の基端部が接着剤、熱融着または止具(図示せず)等により液密に固着されている。ハブ3は、ルーメン5内へのガイドワイヤや医療器具の挿入口、ルーメン5内への薬液や塞栓物質、造影剤等の注入口等として機能し、また、カテーテル1を操作する際の把持部としても機能する。ハブ3の構成材料は、特に限定されないが、例えば、ポリカーボネート、ポリアミド、ポリサルホン、ポリアリレート、メタクリレート-ブチレン-スチレン共重合体等の熱可塑性樹脂が好適に使用できる。
The base end of the shaft 2 of the hub 3 is liquid-tightly fixed with an adhesive, heat-sealing, or a fastener (not shown). The hub 3 functions as an insertion port for a guide wire and medical instruments into the lumen 5, an injection port for a drug solution, an embolic substance, a contrast medium, etc., into the lumen 5, and the like, and also serves as a grip when operating the catheter 1. also functions as The material constituting the hub 3 is not particularly limited, but thermoplastic resins such as polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer can be suitably used.
耐キンクプロテクタ4は、シャフト2の周囲を囲むように設けられる弾性材料からなり、シャフト2とハブ3の連結部位におけるシャフト2のキンクを抑制する。耐キンクプロテクタ4の構成材料は、例えば、天然ゴム、シリコーン樹脂、ポリエステルエラストマー、ポリアミドエラストマー、ポリウレタンエラストマー等が好適に使用できる。
The anti-kink protector 4 is made of an elastic material that surrounds the circumference of the shaft 2 and suppresses kinking of the shaft 2 at the connecting portion between the shaft 2 and the hub 3 . For example, natural rubber, silicone resin, polyester elastomer, polyamide elastomer, polyurethane elastomer, etc. can be suitably used as the constituent material of the kink resistant protector 4 .
以上のように、本実施形態に係るカテーテル1は、先端から基端まで連通するルーメン5を有するシャフト2を備えたカテーテル1であって、シャフト2は、管状に編組された複数の補強線21を備える補強体20と、シャフト2の軸心方向Xの少なくとも1か所に配置されるX線不透過性のマーカー30と、を有し、マーカー30は、補強体20よりもシャフト2の径方向外側に配置され、シャフト2のマーカー30が配置されたマーカー配置部51のルーメン5の内径D1は、シャフト2のマーカー30が配置されていないマーカー不在部52の内径D2よりも小さく、マーカー配置部51の外径D6は、マーカー不在部52の外径D7と同一または実質同一である。実質同一とは、実質同一とは、マーカー配置部51の外径D6とマーカー不在部52の外径D7が数値上同一であるだけでなく実用上同一も意味する。
As described above, the catheter 1 according to this embodiment includes the shaft 2 having the lumen 5 communicating from the distal end to the proximal end. and a radiopaque marker 30 positioned at least one location in the axial direction X of the shaft 2 , the marker 30 being larger in diameter of the shaft 2 than the reinforcement 20 . The inner diameter D1 of the lumen 5 of the marker-placed portion 51 of the shaft 2, which is arranged on the direction outer side and in which the marker 30 is arranged, is smaller than the inner diameter D2 of the marker-free portion 52 of the shaft 2, in which the marker 30 is not arranged. The outer diameter D6 of the portion 51 is the same or substantially the same as the outer diameter D7 of the marker absent portion 52 . “Substantially the same” means that the outer diameter D6 of the marker-placed portion 51 and the outer diameter D7 of the marker-absent portion 52 are not only numerically the same but also practically the same.
実用上同一とは、マーカー配置部51の外径D6とマーカー不在部52の外径D7の差が0以上0.1mm、好ましくは0mm以上0.05mm、より好ましくは0.01mm以上0.03mm以下であることを意味する。外径測定方法は特に限定されないが、レーザー外径装置でマーカーの先端と基端の間にある中間での外径を測定することで、外径および外径差を比較する。
Practically identical means that the difference between the outer diameter D6 of the marker-placed portion 51 and the outer diameter D7 of the marker-absent portion 52 is 0 to 0.1 mm, preferably 0 to 0.05 mm, more preferably 0.01 to 0.03 mm. means that: The outer diameter measurement method is not particularly limited, but the outer diameter and outer diameter difference are compared by measuring the outer diameter at the middle between the tip and the proximal end of the marker with a laser outer diameter device.
上記のように構成したカテーテル1は、内径の小さいマーカー配置部51により、ルーメン5に挿入されるガイドワイヤの保持性を向上できる。また、マーカー不在部52の内径D2がマーカー配置部51の内径D1よりも大きいため、カテーテル1全体としてのガイドワイヤとの摺動抵抗を低減できる。また、マーカー配置部51の外径D6は、マーカー不在部52の外径D7と実質同一であるため、カテーテル1の生体管腔への挿入性を向上できる。したがって、カテーテル1は、ガイドワイヤの保持性および摺動性を維持しつつ、カテーテル1の生体管腔への挿入性を向上できる。
The catheter 1 configured as described above can improve retention of the guide wire inserted into the lumen 5 by the marker placement portion 51 having a small inner diameter. Moreover, since the inner diameter D2 of the marker-absent portion 52 is larger than the inner diameter D1 of the marker-placed portion 51, the sliding resistance of the catheter 1 as a whole with respect to the guide wire can be reduced. In addition, since the outer diameter D6 of the marker-placed portion 51 is substantially the same as the outer diameter D7 of the marker-absent portion 52, the insertability of the catheter 1 into the body lumen can be improved. Therefore, the catheter 1 can improve the ease of inserting the catheter 1 into the body lumen while maintaining the guide wire holdability and slidability.
また、マーカー30の外径D3は、補強体20の外径D4以下であってもよい。これにより、マーカー配置部51の外径D6を、マーカー不在部52の外径D7と実質同一としても、マーカー30を覆う外層40が必要以上に薄くなってシャフト2の強度が低下することを抑制できる。また、マーカー30は、補強体20の部分的に縮径した小径部22に配置されることになるため、マーカー30の軸心方向Xへの意図しない移動を補強体20により効果的に抑制できる。
Also, the outer diameter D3 of the marker 30 may be equal to or less than the outer diameter D4 of the reinforcing body 20. As a result, even if the outer diameter D6 of the marker-placed portion 51 is substantially the same as the outer diameter D7 of the marker-absent portion 52, the outer layer 40 covering the marker 30 is prevented from becoming thinner than necessary and the strength of the shaft 2 is reduced. can. In addition, since the marker 30 is arranged on the small diameter portion 22 of the reinforcing member 20, the unintended movement of the marker 30 in the axial direction X can be effectively suppressed by the reinforcing member 20. .
また、マーカー30の外周面の形状は、シャフト2の軸心方向Xと直交する断面において多角形であってもよい。これにより、マーカー30と、マーカー30の外周面を覆う外層40との接触面積が増加し、安定して接合されて、シャフト2の強度低下を抑制できる。
Also, the shape of the outer peripheral surface of the marker 30 may be polygonal in a cross section perpendicular to the axial direction X of the shaft 2 . As a result, the contact area between the marker 30 and the outer layer 40 covering the outer peripheral surface of the marker 30 is increased, and the markers are stably joined, thereby suppressing a decrease in the strength of the shaft 2 .
また、シャフト2の外径は、0.6mm以上0.9mm以下であり、マーカー配置部51のルーメン5の内径D1は、0.38mm以上0.55mm以下であり、マーカー不在部52のルーメン5の内径D2は、0.45mm以上0.60mm以下であってもよい。これにより、ガイドワイヤの保持性および摺動性を維持しつつ、カテーテル1の生体管腔への挿入性を向上できるカテーテル1を、適切な寸法で実現できる。
The outer diameter of the shaft 2 is 0.6 mm or more and 0.9 mm or less, the inner diameter D1 of the lumen 5 of the marker placement portion 51 is 0.38 mm or more and 0.55 mm or less, and the lumen 5 of the marker absent portion 52 is 0.38 mm or more and 0.55 mm or less. The inner diameter D2 of may be 0.45 mm or more and 0.60 mm or less. As a result, the catheter 1 that can improve the ease of inserting the catheter 1 into the body lumen while maintaining the guide wire holdability and slidability can be realized with appropriate dimensions.
なお、本発明は、上述した実施形態のみに限定されるものではなく、本発明の技術的思想内において当業者により種々変更が可能である。例えば、上述した実施形態では、マーカー配置部51は複数設けられるが、1つのみであってもよい。また、複数のマーカー配置部のうちの1つ以上において、マーカー配置部の外径が、マーカー不在部の外径と異なってもよい。また、複数のマーカー配置部51のルーメン5の内径D1のそれぞれは、同一であっても異なってもよい。また、カテーテル1は、胆管、気管、食道、尿道、またはその他の生体管腔内や体腔内に挿入されて、治療や診断等を行うために用いられてもよい。
It should be noted that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical concept of the present invention. For example, in the embodiment described above, a plurality of marker arrangement portions 51 are provided, but only one may be provided. Moreover, in one or more of the plurality of marker-placed portions, the outer diameter of the marker-placed portion may be different from the outer diameter of the marker-absent portion. In addition, the inner diameters D1 of the lumens 5 of the plurality of marker placement portions 51 may be the same or different. The catheter 1 may also be inserted into bile ducts, trachea, esophagus, urethra, or other biological lumens or body cavities and used for treatment, diagnosis, and the like.
なお、本出願は、2021年11月25日に出願された日本特許出願2021-190785号に基づいており、それらの開示内容は、参照され、全体として、組み入れられている。
This application is based on Japanese Patent Application No. 2021-190785 filed on November 25, 2021, and the disclosure thereof is incorporated by reference.
1 カテーテル
2 シャフト
5 ルーメン
10 内層
11 内表面
20 補強体
21 補強線
30 マーカー
51 マーカー配置部
52 マーカー不在部
D1 マーカー配置部のルーメンの内径
D2 マーカー不在部のルーメンの内径
D3 マーカーの外径
D4 補強体の外径
D5 小径部の外径
D6 マーカー配置部の外径
D7 マーカー不在部の外径
X 軸心方向 1Catheter 2 Shaft 5 Lumen 10 Inner Layer 11 Inner Surface 20 Reinforcement 21 Reinforcement Line 30 Marker 51 Marker Placement Part 52 Marker Absence D1 Inner Diameter of Marker Placement Lumen D2 Marker Absence Lumen Inner Diameter D3 Outer Diameter of Marker D4 Reinforcement Body outer diameter D5 Small diameter part outer diameter D6 Marker placement part outer diameter D7 Marker absent part outer diameter X axial direction
2 シャフト
5 ルーメン
10 内層
11 内表面
20 補強体
21 補強線
30 マーカー
51 マーカー配置部
52 マーカー不在部
D1 マーカー配置部のルーメンの内径
D2 マーカー不在部のルーメンの内径
D3 マーカーの外径
D4 補強体の外径
D5 小径部の外径
D6 マーカー配置部の外径
D7 マーカー不在部の外径
X 軸心方向 1
Claims (4)
- 先端から基端まで連通するルーメンを有するシャフトを備えたカテーテルであって、
前記シャフトは、管状に配置された少なくとも1つの補強線を備える補強体と、
前記シャフトの軸心方向の少なくとも1か所に配置されるX線不透過性のマーカーと、を有し、
前記マーカーは、前記補強体よりも前記シャフトの径方向外側に配置され、
前記シャフトの前記マーカーが配置されたマーカー配置部のカテーテルルーメンの内径は、前記シャフトの前記マーカーが配置されていないマーカー不在部のカテーテルルーメンの内径よりも小さく、
前記マーカー配置部の外径は、前記マーカー不在部の外径と実質同一であることを特徴とするカテーテル。 A catheter comprising a shaft having a lumen communicating from a distal end to a proximal end,
the shaft has a reinforcing body comprising at least one reinforcing line arranged in a tubular shape;
a radiopaque marker positioned at least one location axially of the shaft;
The marker is arranged radially outward of the shaft relative to the reinforcing body,
The inner diameter of the catheter lumen in the marker-placed portion of the shaft where the marker is placed is smaller than the inner diameter of the catheter lumen in the marker-absent portion of the shaft where the marker is not placed,
A catheter, wherein the outer diameter of the marker-placed portion is substantially the same as the outer diameter of the marker-absent portion. - 前記マーカーの外径は、前記補強体の外径以下であることを特徴とする請求項1に記載のカテーテル。 The catheter according to claim 1, wherein the outer diameter of the marker is equal to or less than the outer diameter of the reinforcing body.
- 前記マーカーの外周面の形状は、前記シャフトの軸心方向と直交する断面において多角形であることを特徴とする請求項1または2に記載のカテーテル。 The catheter according to claim 1 or 2, wherein the shape of the outer peripheral surface of the marker is polygonal in a cross section perpendicular to the axial direction of the shaft.
- 前記シャフトの外径は、0.70mm以上0.90mm以下であり、
前記マーカー配置部の内径は、0.38mm以上0.55mm以下であり、
前記マーカー不在部の内径は、0.45mm以上0.60mm以下であることを特徴とする請求項1~3のいずれか1項に記載のカテーテル。 The outer diameter of the shaft is 0.70 mm or more and 0.90 mm or less,
The inner diameter of the marker placement portion is 0.38 mm or more and 0.55 mm or less,
The catheter according to any one of claims 1 to 3, wherein the inner diameter of the marker absent portion is 0.45 mm or more and 0.60 mm or less.
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Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2015008766A (en) * | 2013-06-27 | 2015-01-19 | 朝日インテック株式会社 | Balloon catheter |
WO2017104465A1 (en) * | 2015-12-16 | 2017-06-22 | テルモ株式会社 | Catheter and method of manufacturing same |
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2022
- 2022-11-16 WO PCT/JP2022/042508 patent/WO2023095694A1/en unknown
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2015008766A (en) * | 2013-06-27 | 2015-01-19 | 朝日インテック株式会社 | Balloon catheter |
WO2017104465A1 (en) * | 2015-12-16 | 2017-06-22 | テルモ株式会社 | Catheter and method of manufacturing same |
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