JP7647987B2 - catheter - Google Patents

Description

The present invention relates to a catheter and a method for manufacturing a catheter.

A catheter is an instrument that is inserted into a lumen of a living body and is used to deliver small members or contrast media into the lumen. Such a catheter is described, for example, in Patent Document 1. The catheter described in Patent Document 1 has a shaft member having an outer tube and an inner tube disposed in the lumen of the outer tube. Patent Document 1 describes that a guidewire for guiding a guide shaft member is inserted into the lumen of the shaft member, and therefore the lumen surface of the inner tube needs to have slidability for operating the guidewire. Patent Document 1 also describes that the slidability of the guidewire is improved by forming a slidable polyolefin layer on the inner surface of the polyamide layer that constitutes the catheter tube.

JP 2016 174827 A

However, forming a layer of a slidable polyolefin to ensure the slidability of the guidewire increases the number of steps in the manufacture of the catheter, complicating the manufacturing process. In addition, the invention described in Patent Document 1 requires consideration of the adhesiveness between a material suitable for the catheter tube and the slidable polyolefin layer, which is thought to reduce the freedom in material selection and resin thickness.
The present invention has been made in consideration of the above points, and relates to a catheter that ensures the slidability of a guidewire without adding any process steps or changing any material, and to a method for manufacturing the catheter.

The catheter of the present invention has an inner layer surrounding a main lumen, a reinforcing layer formed from a reinforcing wire and wound so as to be in a twisted position with respect to the main lumen, and an outer layer in which the reinforcing layer is partially embedded and which surrounds the main lumen together with the inner layer, and at least a portion of the inner surface of the inner layer has a convex ridge formed along the reinforcing wire, the convex ridge being the inner surface covering the reinforcing wire, and a portion of the circumferential surface of the reinforcing wire facing the inner diameter side of the lumen is in contact with the inner layer, and another portion of the circumferential surface is in contact with the outer layer .

The method for manufacturing the catheter of the present invention includes a reinforcing layer forming step of winding a reinforcing wire around an inner layer that defines a main lumen to form a reinforcing layer, and a marker fixing step of crimping and fixing ring-shaped metal markers, each of which contains a radiopaque metal material, around the reinforcing layer. In the marker fixing step, a pressing force is applied to the metal markers, causing at least a portion of the reinforcing wire to protrude from the surface of the inner layer to form a convex ridge.

The catheter and catheter manufacturing method of the present invention ensure the slidability of the guidewire without adding any process steps or changing the material.

1 is an overall side view showing an entire catheter of one embodiment of the present invention. 2A is an enlarged view of a vertical cross section of region II shown in FIG. 1, and FIG. 2B is an enlarged view of range C shown in FIG. 2(a) is a cross-sectional view of the catheter taken along the dashed line between arrows A and A in FIG. 2(a) as viewed in the direction of arrows A and A. FIG. 2(a) is a cross-sectional view of the catheter taken along the dashed line between arrows B, B in FIG. 2(a) as viewed in the direction of arrows B, B. FIG. FIG. 3 is a diagram for explaining another example of the convex ridges shown in FIG. 2( a ) and FIG. 2 ( b ). 3A is a diagram for explaining a configuration in which the diameter of the inner layer in the straight pipe portion shown in FIG. 2A decreases toward the tip. FIG. 10A to 10C are diagrams for explaining a reinforcing layer forming step in the present embodiment. FIG. 8 is a diagram for explaining a marker fixing step following the step shown in FIG. 7 . 9 is a vertical cross-sectional view showing a state of a straight pipe portion in which a part of the reinforcing layer has been removed from the configuration of FIG. 8 . FIG. 10 is a vertical cross-sectional view showing a state of a straight pipe portion having an outer layer formed in the configuration of FIG. 9 .

Hereinafter, one embodiment of the present invention will be described.
[catheter]
Fig. 1 is an overall side view showing the entire catheter of this embodiment. Fig. 2(a) is an enlarged view of a longitudinal section of region II shown in Fig. 1, and Fig. 2(b) is an enlarged view of range C shown in Fig. 2(a). Fig. 3 is a cross section of the catheter 1 taken along a dashed line between arrows A and A shown in Fig. 2(a) (hereinafter referred to as "cross section A") as viewed in the direction of arrows A and A. Fig. 4 is a cross section of the catheter 1 taken along a dashed line between arrows B and B shown in Fig. 2(a) (hereinafter referred to as "cross section B") as viewed in the direction of arrows B and B.
The catheter 1 has a tubular body 10 and an operating section 90 that is connected to the base end of the tubular body 10 .

The operation portion 90 includes a main body case 94 that is held by the user, and a hub 96. In the tubular main body 10, the side of the main body case 94 relative to the tip T is hereinafter referred to as the "base end side."
A syringe (not shown) is attached to the hub 96. The hub 96 is provided at the rear end of the main case 94, and the syringe is attached to the rear of the hub 96. By injecting a medicinal solution or the like into the hub 96 with the syringe, the medicinal solution or the like can be supplied to the subject's body cavity via the main lumen 20 (FIG. 2(a) etc.). Examples of the medicinal solution or the like include contrast agents, liquid anticancer agents, physiological saline, and medicinal solutions such as NBCA (n-butyl-2-cyanoacrylate) used as an instant adhesive, as well as medical devices such as detachable coils and beads (embolic spherical substances).
An operating wheel is rotatably provided on the main body case 94 for advancing and retracting a guide wire (not shown) inserted through the tubular body 10 via a hub 96. A recess 95 is also formed in the main body case 94. A slider 98 that is slidable forward and backward is provided in the recess 95. The slider 98 is a mechanism for fixing or releasing the rotation of the operating wheel.

The straight tube section 101 has a constant outer diameter and an expanding diameter section 102 whose outer shape expands from the straight tube section 101 toward the main body case 94. However, the tubular main body 10 is not limited to having a straight tube section 101 and an expanding diameter section 102, and may have a constant outer shape as a whole. As shown in Figures 2(a) and 2(b), the straight tube section 101 is also called a sheath, and is a hollow tubular and long member with a main lumen 20 formed therein through a hole.

The straight tube section 101 of this embodiment has an inner layer 24 surrounding the main lumen 20, a reinforcing layer 30 formed of a reinforcing wire 32 and wound around the main lumen 20 in a twisted position, and an outer layer 50 in which the reinforcing layer 30 is embedded and which surrounds the main lumen 20 together with the inner layer 24. A convex rib 35 is formed along the reinforcing wire 32 on at least a part of the inner surface of the inner layer 24. Here, the convex rib 35 refers to a long protrusion extending in a planar direction. The extension direction of the convex rib 35 may be a linear direction or a rotational direction. The rotational direction may be a spiral rotation.
2(a) and 2(b) are formed by the reinforcing wire 32 pressing the inner layer 24 toward the center of the main lumen 20, causing the inner layer 24 to protrude from the inner surface 201 of the main lumen 20. As shown in Fig. 2(b) , in the reinforcing wire 32, the entire reinforcing wire 32 is covered by the inner layer 24, and the entire reinforcing wire 32 is wound radially outward from the inner surface of the inner layer 24.
In addition, the above-mentioned "wound so as to be in a twisted position" refers to the reinforcing layer 30 being wound so as to be in a position relative to the main lumen 20 that is neither parallel to the main lumen 20 nor intersects with it (is not on the same plane).

Furthermore, the straight pipe section 101 is provided around the reinforcing layer 30 and further includes radiopaque metallic markers 14, 16, 18, and the protruding strips 35 are formed in overlapping regions _D14 , _D16 , _D18 of the inner surface 201 that overlap at least the metallic markers 14, 16, 18. However, in this embodiment, the inner layer ₂₄ protrudes by the reinforcing wire 32 to form the protruding strips 35 _not only in the overlapping regions _D14 , _D16 , _D18 but also between the overlapping regions D14, _D16 , _D18 . As described later, the metallic markers 14, 16, 18 are formed by crimping from above the reinforcing layer 30. In this embodiment, the pressure applied by the metallic markers 14, 16, 18 to the inner layer 24 via the reinforcing wire 32 can be adjusted to cause the reinforcing wire 32 to protrude from the inner surface 201.

In the above-described catheter 1, the straight tube section 101 has a laminated structure, and an inner layer (main tube) 24 and an outer layer 50 are laminated in this order from the inner diameter side around the main lumen 20 to form the straight tube section 101. The inner layer 24 and the outer layer 50 are made of a flexible resin material, each of which is cylindrical and has a substantially uniform thickness.
Each of these configurations will be described in turn below.

(Outer layer)
The outer layer 50 is a cylindrical portion constituting the main wall thickness of the tubular body 10. Inside the outer layer 50, a reinforcing layer 30 and metal markers 14, 16, and 18 are provided in this order from the inner diameter side. The reinforcing layer 30 and the metal markers 14, 16, and 18 are arranged coaxially with the tubular body 10. It is preferable that the outer layer has a substantially uniform thickness. A hydrophilic layer (not shown) is formed on the surface of the outer layer 50.
Furthermore, this embodiment is not limited to such a configuration, and a sub-tube (not shown) may be further formed inside the outer layer 50, and an operating wire (not shown) may be inserted through this sub-tube to bend the area including the tip T of the straight pipe portion 101.

The material of the outer layer 50 may be a thermoplastic polymer material, such as polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), polyamide elastomer (PAE), nylon elastomer such as polyether block amide (PEBA), polyurethane (PU), ethylene-vinyl acetate resin (EVA), polyvinyl chloride (PVC), or polypropylene (PP).
Furthermore, an inorganic filler may be mixed into the outer layer 50. Examples of the inorganic filler include contrast agents such as barium sulfate and bismuth subcarbonate. By mixing the contrast agent into the outer layer 50, the X-ray contrast of the tubular main body 10 in the body cavity can be improved.

(Inner layer)
The inner layer 24 is the innermost layer of the tubular body 10, and its inner wall surface defines the main lumen 20. The cross-sectional shape of the main lumen 20 is not particularly limited, but is circular in this embodiment as shown in Figures 3 and 4. When the main lumen 20 has a circular cross section, its diameter may be uniform along the longitudinal direction of the tubular body 10, or may vary depending on the position in the longitudinal direction.
The material of the inner layer 24 may be, for example, a fluorine-based thermoplastic polymer resin. Specific examples of the fluorine-based thermoplastic polymer material include polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), and perfluoroalkoxy fluorine resin (PFA). By forming the inner layer 24 from such a fluorine-based polymer material, the deliverability when supplying a drug solution or the like through the main lumen 20 is improved. In addition, the sliding resistance when inserting a guidewire or the like into the main lumen 20 is reduced.

(Metal marker)
The metal markers 14, 16, and 18 are formed in the order of increasing distance from the operation unit 90. The metal markers 14, 16, and 18 in this embodiment are all rings containing a metal material, such as platinum, that is opaque to radiation such as X-rays. The metal markers 14 and 16 can contribute to the operator visually recognizing the position including the tip T of the straight tube portion 101. This makes it possible to easily determine the optimal timing for operating the catheter 1. In addition, the metal marker 18, which is provided closer to the operation unit 90 than the metal marker 16, can allow the operator to grasp the cutting position of the detachable coil in the main lumen 20 of the catheter 1 by using the third marker 18 as a guide, for example, when the catheter 1 is used to introduce a detachable coil into the body of a subject.
However, this embodiment is not limited to the above-mentioned configuration having three metal markers, and it is sufficient that at least one marker is made of a radiopaque material such as metal, and the other markers may be radiotransparent. The number of markers is also arbitrary, and may be, for example, one marker.

In this embodiment, the metallic markers 14, 16, and 18 are all members having the same shape and made of the same material. The same shape means that the metallic markers 14, 16, and 18 have the same outer diameter and the same radial height of the straight pipe section 101. In addition, by constructing the metallic markers 14, 16, and 18 from the same material and shape, this embodiment allows the metallic markers 14, 16, and 18 to be produced using a common mold, which reduces the manufacturing costs compared to producing the metallic markers as members having different shapes.

(Convex stripe)
In this embodiment, the convex strips 35 are formed by the reinforcing wires 32 that constitute the reinforcing layer 30. The reinforcing layer 30 is a protective layer that protects the inner layer 24 in the tubular body 10. The presence of the reinforcing layer 30 increases resistance to an external force applied in the radial direction of the main lumen 20, and can prevent the main lumen 20 from being deformed.
The reinforcing layer 30 is formed by winding a reinforcing wire 32. The material of the reinforcing wire 32 may be a metal material such as tungsten (W), stainless steel (SUS), nickel-titanium alloy, steel, titanium, copper, titanium alloy, or copper alloy, or a resin material such as polyimide (PI), polyamideimide (PAI), or polyethylene terephthalate (PET) having a higher shear strength than the inner layer 24 and the outer layer 50. The material of the reinforcing wire 32 is preferably a metal material, and in this embodiment, a thin stainless steel wire is used as the reinforcing wire 32.

The reinforcing layer 30 shown in Figures 2(a) to 4 is a mesh-like braided member formed by a plurality of reinforcing wires 32. Therefore, the ridges 35 are formed in a mesh-like shape along the braided member. As shown in Figure 3, the reinforcing wires 32 cannot be seen in cross section A of Figure 2(a) , but can be seen in cross section B. With this configuration, this embodiment can achieve both prevention of deformation of the main lumen 20 by the reinforcing layer 30 and maintenance of flexibility.
In addition, in this embodiment, the provision of the reinforcing layer 30 makes the lower layer of the metal markers 14, 16, 18 less susceptible to mechanical deformation, and as a result, the metal markers 14, 16, 18 can be attached to the inner layer 24 and the reinforcing wire 32 by crimping.

The ridges 35 of this embodiment reduce the contact area between the inner surface 201 of the main lumen 20 and the guidewire (not shown) by making point contact with the ridges 35, thereby improving the slidability of the guidewire within the main lumen 20. Furthermore, this embodiment is formed by the inner surface 201 that covers the reinforcing wire 32. In this embodiment, the reinforcing wire is covered by the inner layer 24 of the inner surface 201 and is configured not to be exposed from the inner surface 201. In this way, this embodiment covers the surface of the ridges 35 with the inner layer 24 that provides good slidability, further improving the slidability of the guidewire within the main lumen 20.

However, this embodiment is not limited to a configuration in which the surface of the ridge 35 is covered by the inner layer 24. FIG. 5 is a diagram for explaining another example of the ridge, and shows an example in which the reinforcing wire 32 exposed from the inner surface 201 is a ridge. In FIG. 5, the exposed portion 36 of the reinforcing wire 32 is a ridge. With this configuration, the reinforcing wire 32 breaks through the inner layer 24 and comes into direct contact with the guide wire. At this time, the width of the exposed portion 36 as a ridge is narrower than when it is covered by the inner layer 24, and the contact area with the guide wire can be reduced to improve the sliding property. Furthermore, since the reinforcing wire 32 is made of a metal with high sliding property, this embodiment can obtain high sliding property with the guide wire even if the exposed portion 36 is a ridge.

Furthermore, this embodiment is not limited to the reinforcing wire 32 in which the convex stripe is covered by the inner layer 24 or the exposed portion 36 in which the reinforcing wire 32 is exposed as described above. The convex stripe of this embodiment may include the exposed portion 36, which is the portion of the reinforcing wire 32 exposed from the inner surface 201, and the inner layer 24 that covers the portion of the reinforcing wire 32 excluding the exposed portion 36. That is, this embodiment may include a mixture of the convex stripe 35 formed of the reinforcing wire 32 covered by the inner layer 24 and the exposed portion 36, which is the reinforcing wire 32 shown in FIG. 5, as shown in FIG. 2(a) and FIG. 2(b).
In such a case, the present embodiment is not limited to the case in which all of the portions protruding from the inner layer 24 are exposed portions 36 as shown in Fig. 5. In the present embodiment, a portion of the portions protruding from the inner layer 24 may be exposed portions 36, and another portion may be covered by the inner layer 24.

The above configuration can be realized by adjusting the pressing force when crimping the metallic markers 14, 16, and 18. That is, by relatively reducing the pressing force when crimping the metallic markers 14, 16, and 18, this embodiment can form a convex strip in which the reinforcing wire 32 is covered by the inner layer 24 as shown in Figures 2(a), 2(b), and 3. Also, by relatively increasing the pressing force when crimping the metallic markers 14, 16, and 18, this embodiment can form a convex strip in which the reinforcing wire 32 breaks through the inner layer 24 and is exposed as shown in Figure 5.
Furthermore, this embodiment is not limited to a case where all of the ridges formed on the straight tube portion 101 are covered with the inner layer 24 or where the reinforcing wire 32 is exposed, and both may be mixed. This is because the ridges can improve the slidability of the guide wire regardless of whether they are covered with the inner layer 24 or not.

In addition, as described above, in this embodiment, the convex ribs are not limited to those formed in the overlapping regions D14, _D16 , and _D18 , but may be formed in the non-overlapping regions _E1 , _E2 , and _E3 shown in Fig. 2(a) In this configuration, the convex ribs are formed not in the process of crimping the metal markers 14, 16, and 18, but in the process of removing the main core wire 22 from the tubular body 10 to form the main lumen 20, which will be described later.

Furthermore, the catheter 1 of this embodiment is not limited to a configuration in which a single-layer reinforcing layer 30 in which the reinforcing wire 32 is wound in a single layer is formed in the overlapping regions _D14 , _D16 , and _D18 of the straight tube section 101, but may be one in which a multi-layer reinforcing layer 30 is formed. The multi-layer reinforcing layer 30 may be formed in all or part of the overlapping regions _D14 , _D16 , and _D18 . When the multi-layer reinforcing layer 30 is formed in part of the overlapping regions _D14 , _D16 , and _D18 , in this embodiment, a convex ridge may be formed only on the inner surface 201 that overlaps with the multi-layer reinforcing region.
Such a configuration can be realized when a pressing force (hereinafter, "strong pressing force") stronger than the pressing force (hereinafter, "weak pressing force") used to crimp a metal marker on a single-layer reinforcing layer 30 is applied to the metal marker on the multiple reinforcing layer 30, and the threshold pressing force at which a convex rib is formed is between the weak pressing force and the strong pressing force.

In the case where the straight pipe section 101 has a single-layer reinforcement layer 30 and a multi-layer reinforcement layer 30, in this embodiment, the convex streaks may be formed in the overlapping region _D14 , etc. and the non-overlapping region _E1 , etc. of the inner surface 201. The convex height, which is the height from the inner surface 201 of the convex streaks formed in the overlapping region _{D14, etc.} , may be higher than the convex height of the convex streaks formed in the non-overlapping region E1, etc. Such a configuration can be realized when a strong pressing force is applied to the metal markers on the multi-layer reinforcement layer 30 to be crimped, and a weak pressing force is applied to the single-layer reinforcement layer 30 to be crimped, and the threshold pressing force at which the convex streaks are formed is greater than the weak pressing force.

Furthermore, this embodiment is not limited to the configuration in which the diameter of the inner layer 24 of the straight pipe portion 101 is constant as shown in FIG.
Fig. 6 is a diagram for explaining a configuration in which the diameter of the inner layer 24 in the straight tube portion 101 decreases toward the tip T (Fig. 1). The tubular body 10 shown in Fig. 6 has a thin-diameter portion F, which is thinner than the other portions G, in a portion including the open end H of the main lumen 20, and the thickness of the inner layer 24 in the thin-diameter portion F is thinner than the thickness of the other portions G. In such a configuration, in this embodiment, a convex ridge may be formed on the inner surface 201 of the thin-diameter portion F.
Such a configuration can be realized when the metallic markers 14, 16 and the metallic marker 18 are crimped with the same pressing force in the narrow diameter portion F and the other portion G. Then, the thickness of the inner layer 24 in the narrow diameter portion F is set to a thickness at which the protrusions are formed by this pressing force, and the thickness of the inner layer 24 in the narrow diameter portion F is made thicker than the thickness at which the protrusions are formed by the pressing force.
According to this configuration, it is possible to efficiently form the ridges in the small diameter portion F where the slidability of the guide wire is reduced.

Furthermore, this embodiment is not limited to a configuration in which the reinforcing layer 30 is a mesh-like braided member, and for example, the reinforcing layer 30 may be a coil formed by spirally winding the reinforcing wire 32 around the inner layer 24. With such a configuration, the pitch and density of the reinforcing wire 32 can be adjusted as desired, and the degree of freedom in adjusting the strength of the inner layer 24 is increased.

(Catheter Manufacturing Method)
Next, a method for manufacturing the above-described catheter 1 will be described. The method for manufacturing the catheter of this embodiment includes a reinforcing layer forming step of winding a reinforcing wire 32 around the inner layer 24 that defines the main lumen 20 to form the reinforcing layer 30, and a marker fixing step of crimping and fixing ring-shaped metal markers 14, 16, and 18, each of which contains a radiopaque metal material, around the reinforcing layer 30. In the marker fixing step, a pressing force is applied to the metal markers 14, 16, and 18, causing at least a portion of the reinforcing wire to protrude from the surface of the inner layer to form a convex ridge.

Figure 7 is a diagram for explaining the reinforcing layer forming process, and is a vertical cross-sectional view of the straight pipe section 101 with the reinforcing layer 30 wound around the inner layer 24. Figure 8 is a diagram for explaining the marker fixing process, and is a vertical cross-sectional view of 101 with the metal markers 14, 16, and 18 fixed to the upper layer of the reinforcing layer 30. Figure 9 is a vertical cross-sectional view of the straight pipe section 101 with the reinforcing layer 30 in the region between the metal markers 14 and 16 removed from the configuration of Figure 8. Figure 10 is a vertical cross-sectional view of the straight pipe section 101 with the configuration of Figure 9 with the outer layer 50 formed.

In the manufacturing process of the catheter 1 of this embodiment, first, as shown in FIG. 7, an inner layer 24 is formed around the main core wire 22. The main core wire 22 is a mandrel (core material) and is a wire material with a circular cross section that defines the main lumen 20. The material of the main core wire 22 is not particularly limited, but stainless steel can be used. The inner layer 24 can be formed by dipping the main core wire 22 in a coating liquid in which a fluorine-based polymer such as polytetrafluoroethylene (PTFE) is dispersed in a solvent, and then drying it. Next, multiple reinforcing wires 32 are braided in a net shape on the outer surface of the inner layer 24 to form the reinforcing layer 30.

Next, in the marker fixing step, as shown in Fig. 8, the metallic markers 14 and 16 are crimped and fixed around the reinforcing layer 30 so that the metallic marker 16 is located closer to the base end than the metallic marker 14. Furthermore, the metallic marker 18 is crimped and fixed around the reinforcing layer 30 closer to the base end than the metallic marker 16. At this time, the reinforcing wires 32 are all positioned between the inner layer 24 and the metallic markers 14, 16, and 18 and pressed to reduce their diameter toward the main core wire 22, forming a convex streak on the inner surface 201.
Next, in this embodiment, the reinforcing layer 30 between the metallic markers 14 and 16 is removed as shown in Fig. 9. The reinforcing layer 30 can be removed by any means such as a laser or a cutting blade.

Next, in this embodiment, as shown in FIG. 10, an outer layer 50 is formed around the inner layer 24, the reinforcing layer 30, and the metal markers 14 and 16. The outer layer 50 may be formed by coating extrusion, in which a molten resin material is applied to the surface of the structure. Alternatively, a resin ring or resin tube formed in advance into a ring or tube shape may be attached around the structure, and then thermally shaped using a heat shrink tube or the like.

In this embodiment, the main core wire 22 is removed from the tubular body 10 to form the main lumen 20. The reinforcing wire 32 wound around the inner layer 24 applies a force to the main core wire 22 in the radial direction of the main core wire 22. Therefore, when the main core wire 22 is removed, the reinforcing wire 32 is slightly reduced in diameter toward the main lumen 20, and presses against the inner layer 24 to protrude from the inner surface 201, thereby forming a convex ridge.
In this embodiment, the above process allows the formation of convex ridges in a separate process from the process of crimping the metal markers 14, etc., making it possible to form convex ridges even in non-overlapping areas where there are no metal markers 14, etc.

In this embodiment, the distal end portion of the tubular body 10 is further shaped to be rounded by a method such as polishing or plastic deformation such as heating (see FIG. 2(a)). A hydrophilic layer (not shown) is formed on the surface of the outer layer, and an operating section 90 is attached to the proximal end portion of the tubular body 10. With the above steps, the catheter 1 is completed.
The catheter and the method for manufacturing the catheter according to the present embodiment described above can form ridges on the inner surface 201 of the inner layer 24. Providing ridges on the inner surface 201 can reduce the contact area between the guidewire inserted into the main lumen 20 and the inner surface 201, thereby improving the slidability of the guidewire in the main lumen 20. Furthermore, since such ridges can be realized in the process of crimping a metallic marker or the like to fix it to the reinforcing layer, this embodiment can ensure the slidability of the guidewire without adding any process steps or changing the material.

In the above-described embodiment, the various components of the present invention do not necessarily have to exist independently. It is acceptable for multiple components to be formed as one member, for one component to be formed from multiple members, for one component to be a part of another component, or for part of one component to overlap with part of another component.
In the description of the catheter manufacturing method of this embodiment, the steps are described in order, but the order does not limit the order or timing of performing the steps. Therefore, when carrying out this manufacturing method, the order of the steps can be changed to the extent that does not cause any problems in terms of the content, and some or all of the timing of performing the steps may overlap with each other.

The above embodiment encompasses the following technical ideas.
(1) A catheter having an inner layer surrounding a main lumen, a reinforcing layer formed of a reinforcing wire and wound so as to be in a twisted position with respect to the main lumen, and an outer layer in which the reinforcing layer is embedded and which, together with the inner layer, surrounds the main lumen, wherein a convex ridge is formed along the reinforcing wire on at least a portion of the inner surface of the inner layer.
(2) The catheter of (1), wherein the protrusion is the inner surface covering the reinforcing wire.
(3) The catheter of (1), wherein the ridge includes an exposed portion that is a portion of the reinforcing wire exposed from the inner surface, and a portion of the reinforcing wire of the ridge excluding the exposed portion.
(4) The catheter according to (1), wherein the protrusion is the reinforcing wire exposed from the inner surface.
(5) A catheter according to any one of (1) to (4), further comprising a radiopaque metal marker arranged around the reinforcing layer, the protrusion being formed in an overlapping area of the inner surface that overlaps with the metal marker.
(6) A catheter according to any one of (1) to (5), further comprising a radiopaque metal marker arranged around the reinforcing layer, the protrusion being formed in a non-overlapping area of the inner surface that does not overlap with the metal marker.
(7) A catheter according to any one of (1) to (6), further comprising a radiopaque metallic marker arranged around the reinforcing layer, the convex stripe being formed in an overlapping region of the inner surface that overlaps with the metallic marker and a non-overlapping region that does not overlap with the metallic marker, and the convex height, which is the height of the convex stripe formed in the overlapping region from the inner surface, is higher than the convex height of the convex stripe formed in the non-overlapping region.
(8) A catheter according to any one of (1) to (7), wherein the reinforcing layer has, in the longitudinal direction, a single-layer reinforcement region in which the reinforcing wire is wound in a single layer, and a multi-layer reinforcement region in which the reinforcing wire is wound in multiple layers, and the convex ribs are formed only on the inner surface that overlaps the multi-layer reinforcement region.
(9) A catheter according to any one of (1) to (7), wherein the reinforcing layer has, in the longitudinal direction, a single-layer reinforcement region in which the reinforcing wire is wound in a single layer, and a multi-layer reinforcement region in which the reinforcing wire is wound in multiple layers, the convex ribs are formed on the inner surface overlapping the single-layer reinforcement region and on the inner surface overlapping the multi-layer reinforcement region, and the convex height, which is the height from the inner surface of the convex rib formed on the inner surface overlapping the multi-layer reinforcement region, is higher than the convex height of the convex rib formed on the inner surface overlapping the single-layer reinforcement region.
(10) A catheter according to any one of (1) to (9), wherein the inner layer has a thin-diameter portion in a part of the length region including the open end of the main lumen, the thin-diameter portion having a smaller diameter than other parts, the thin-diameter portion having a thinner wall thickness than the other parts, and the ridges are formed on the inner surface of the thin-diameter portion.
(11) A catheter according to any one of (1) to (10), wherein the reinforcing layer is a coil formed by spirally winding the reinforcing wire around the inner layer, and the convex stripe is formed spirally along the reinforcing wire.
(12) A catheter according to any one of (1) to (10), wherein the reinforcing layer is a mesh-like braided member formed by the reinforcing wire, and the protrusions are formed in a mesh-like shape along the braided member.
(13) A method for producing a catheter according to the present invention, comprising: a reinforcing layer forming step of winding a reinforcing wire around an inner layer defining a main lumen to form a reinforcing layer; and a marker fixing step of crimping and fixing ring-shaped metal markers, each of which includes a radiopaque metal material, around the reinforcing layer;
A method for manufacturing a catheter, wherein in the marker fixing step, a pressing force is applied to the metal marker, causing at least a portion of the reinforcing wire to protrude from the surface of the inner layer to form a convex streak.

1: Catheter 10: Tubular body 14, 16, 18: Metal marker 20: Main lumen 22: Main core wire 24: Inner layer 30: Reinforcing layer 32: Reinforcing wire 50: Outer layer 90: Operation section 94: Body case 95: Recess 96: Hub 98: Slider 101: Straight tube section 102: Expanded diameter section 201: Inner surface C: Ranges _D14 , _D16 , _D18 : Overlapping regions _E1 , _E2 , _E3 : Non-overlapping region F: Thin diameter section G: Other sections H: Open end T: Tip

Claims (7)

an inner layer surrounding the main lumen;
a reinforcing layer formed by a reinforcing wire wound around the main lumen such that the reinforcing layer is in a twisted position with the main lumen;
an outer layer in which the reinforcing layer is partially embedded and which, together with the inner layer, surrounds the main lumen;
A protrusion is formed along the reinforcing wire on at least a part of an inner surface of the inner layer ,
The ridge is the inner surface covering the reinforcing wire,
a portion of the circumferential surface of the reinforcing wire facing the inner diameter side of the lumen is in contact with the inner layer;
Another portion of the circumferential surface is in contact with the outer layer . an inner layer surrounding the main lumen;
a reinforcing layer formed by a reinforcing wire wound around the main lumen such that the reinforcing layer is in a twisted position with the main lumen;
an outer layer in which the reinforcing layer is partially embedded and which, together with the inner layer, surrounds the main lumen;
A protrusion is formed along the reinforcing wire on at least a part of an inner surface of the inner layer,
A catheter further comprising a radiopaque metal marker disposed around the reinforcing layer and in contact with the surface of the reinforcing wire to crimp the reinforcing wire , the protrusion being formed in an overlapping region of the inner surface that overlaps with the metal marker . an inner layer surrounding the main lumen;
a reinforcing layer formed by a reinforcing wire wound around the main lumen such that the reinforcing layer is in a twisted position with the main lumen;
an outer layer in which the reinforcing layer is partially embedded and which, together with the inner layer, surrounds the main lumen;
A protrusion is formed along the reinforcing wire on at least a part of an inner surface of the inner layer,
A catheter further comprising a radiopaque metal marker disposed around the reinforcing layer and in contact with the surface of the reinforcing wire to crimp the reinforcing wire , the protrusion being formed in a non-overlapping region of the inner surface that does not overlap with the metal marker. an inner layer surrounding the main lumen;
a reinforcing layer formed by a reinforcing wire wound around the main lumen such that the reinforcing layer is in a twisted position with the main lumen;
an outer layer in which the reinforcing layer is partially embedded and which, together with the inner layer, surrounds the main lumen;
A protrusion is formed along the reinforcing wire on at least a part of an inner surface of the inner layer,
A catheter further comprising a radiopaque metallic marker arranged around the reinforcing layer to crimp the reinforcing wire , the convex stripe being formed in an overlapping region of the inner surface that overlaps with the metallic marker and a non-overlapping region that does not overlap with the metallic marker, and a convex height, which is the height from the inner surface of the convex stripe formed in the overlapping region, is higher than the convex height of the convex stripe formed in the non-overlapping region. an inner layer surrounding the main lumen;
a reinforcing layer formed by a reinforcing wire wound around the main lumen such that the reinforcing layer is in a twisted position with the main lumen;
an outer layer in which the reinforcing layer is partially embedded and which, together with the inner layer, surrounds the main lumen;
A protrusion is formed along the reinforcing wire on at least a part of an inner surface of the inner layer,
a catheter in which the reinforcing layer has, in the longitudinal direction, a single-layer reinforcement region in which the reinforcing wire is wound in a single layer, and a multi-layer reinforcement region in which the reinforcing wire is wound in multiple layers, the convex streaks are formed on the inner surface overlapping the single-layer reinforcement region and on the inner surface overlapping the multi-layer reinforcement region, and the convex height, which is the height from the inner surface of the convex streaks formed on the inner surface overlapping the multi-layer reinforcement region, is higher than the convex height of the convex streaks formed on the inner surface overlapping the single-layer reinforcement region . 6. The catheter according to claim 1, wherein the reinforcing layer is a coil formed by spirally winding the reinforcing wire around the inner layer, and the ridge is formed in a spiral shape along the reinforcing wire. The catheter according to claim 1 , wherein the reinforcing layer is a mesh-like braided member formed by the reinforcing wire, and the ridges are formed in a mesh-like shape along the braided member.

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