JP5929315B2 - Medical device and method for manufacturing medical device - Google Patents

Description

  The present invention relates to a medical device and a method for manufacturing the medical device. In particular, the present invention relates to a medical device suitable for a catheter to be inserted into a body cavity and a method for manufacturing the medical device.

  2. Description of the Related Art In recent years, various medical devices that can manipulate the direction of entry into a body cavity by bending a tip (hereinafter referred to as “distal end”) have been provided. As a typical example, for example, a catheter is known. In this catheter, the distal end portion is required to be flexibly formed so as to be bent easily, and the intermediate portion and the rear end portion on the operation side (hereinafter referred to as “proximal end portion”) are formed in the body cavity. In order to require torque characteristics and easy progress, it is required to form a high rigidity. Further, in order to bend the distal end portion, there is a technique for bending the distal end portion by fixing an operation wire to the distal end portion of the main lumen of the catheter and pushing / pulling the operation wire. It is disclosed (for example, see Patent Document 1).

  In Patent Document 1, a pair of operation wires are fixed to the outer periphery of the main lumen of the catheter through an angle of 180 degrees, and the pair of operation wires are operated on the proximal end side, The one that bends the distal end is described. Since the tubular main body constituting this catheter is formed by closely winding a flat metal plate material in a coil shape, the rigidity is high, but the flexibility is poor. On the other hand, on the distal end side of the tubular body, a plurality of short tube rings are arranged through a predetermined gap, a part of the tubular body is notched through the predetermined gap, or the coil is formed through the predetermined gap. The distal end side is formed by a circular element with a gap. As described above, since the gap is interposed between the short tube rings, notches, and windings on the tip side, which is a circular element, the distal end side has flexibility, and the distal end side is flexible by operating the operation wire. The end portion can be easily bent. In addition, since the circular element formed by the short tube ring or coil winding on the distal end side is through a gap, the pair of parallel wires in the longitudinal direction at a position 90 degrees in the circumferential direction with the operating wire. It is connected to the closely wound tubular body using a connecting portion. Circular elements formed by notches are also linearly connected by uncut portions. Further, by connecting in this way, the deflection direction of the circular elements is restricted, and stable bending is realized without unexpectedly bending (blurring) to the fixed side by the connecting member.

JP 2003-144554 A

  However, the invention described in Patent Document 1 has the following problems. That is, since the distal end portion cannot be bent in the fixing direction by the connecting member, it cannot be bent in the direction connected by the connecting member. Therefore, when the affected part exists in the direction of the connecting member, the entire tube body needs to be bent after being rotated by 90 degrees.

  Here, when the tube body is rotated, torque (torsional strength) acts on the tube body. Since the tube body of the catheter of Patent Document 1 has a spiral shape, the torque transmission performance decreases during this rotation or the like. In addition, since the distal end is fixed in the axial direction, it is not possible to perform fine bending in various directions by pushing / pulling the operation wire. Furthermore, when the operation wire is operated The curvature of the distal end of the catheter is uniquely determined according to the pulling length. For this reason, there has been a problem that it is difficult to allow the catheter to freely enter a body cavity that branches at various angles.

  The present invention has been made in view of the above problems, and provides a medical device capable of easily realizing desired mechanical characteristics such as a flexible distal end and a hard proximal end. is there.

The medical device of the present invention is used by being inserted into a body cavity and has a flexible long tubular body,
The tubular body is
A first tubular body made of a wire material;
A melting section provided at an end portion of the wire material of the first tubular body,
Have a, a second tubular body that Do from line materials,
An end of the wire material of the second tubular body is connected to the melted portion of the first tubular body;
A taper-cut portion that expands toward the end connected to at least one of the inner peripheral surface of the melting portion of the first tubular body or the inner peripheral surface of the end portion of the second tubular body. Is formed so that the bending rigidity between the first tubular body and the second tubular body with the end portion as a boundary is continuous .

In the medical device of the present invention, as a more specific embodiment, the first tubular body is formed in a coil shape by winding one or a plurality of wire materials in one or multiple lines,
When the ends of the wire material of the first tubular body are melted, adjacent wire materials are joined together to form an end surface in the melted portion, and the end of the wire material of the second tubular body is formed on the end surface. It may be connected.

In the medical device of the present invention, as a more specific embodiment, the second tubular body is formed in a coil shape by winding one or a plurality of wire materials in one or multiple lines,
When the end portions of the wire material of the second tubular body are melted, adjacent wire materials are joined to each other, a melted portion is formed in the second tubular body, and an end surface is formed in the melted portion,
The end surface of the first tubular body and the end surface of the second tubular body may be connected to each other.

In the medical device of the present invention, as a more specific embodiment, the first tubular body is formed in a coil shape by winding one or a plurality of wire materials in one or multiple lines,
The second tubular body is formed by braiding a plurality of wire materials into a mesh shape,
The end part of the mesh-like wire material of the second tubular body may be connected to the end surface of the first tubular body.

  Further, in the medical device of the present invention, as a more specific embodiment, the end surface joined and formed by melting the end portion of the wire material is flattened by cutting and polishing the melted portion. It may be a thing.

  Moreover, in the medical device of the present invention, as a more specific embodiment, the end surface joined and formed by melting the end portion of the wire material has a thickness in the outer diameter direction by polishing the outer periphery. It may be thinned.

In the medical device of the present invention, as a more specific embodiment, the first tubular body and the second tubular body are formed by braiding a plurality of wire materials into a mesh shape,
The intersections of the ends of the wire material of the braid of the first tubular body and the second tubular body may be connected to each other.

  In the medical device of the present invention, as a more specific embodiment, the first tubular body and the second tubular body may be connected by welding.

  In the medical device of the present invention, as a more specific embodiment, the first tubular body and the second tubular body may be different in the number of filaments.

Moreover, in the medical device of the present invention, as a more specific embodiment, the first tubular body and the second tubular body are different from each other in the shape of the end of the wire material or the diameter of the wire material,
The end portions of the mutual wire materials may be melted to form end surfaces of the melted portions, and the end surfaces may be connected to each other.

  In the medical device of the present invention, as a more specific embodiment, the outer circumferences of the connecting portions of the first tubular body and the second tubular body may be further brazed.

  In the medical device of the present invention, as a more specific embodiment, the wire material of the first tubular body and the wire material of the second tubular body may be made of the same kind of metal.

In the medical device of the present invention, as a more specific embodiment, the other end of the first tubular body opposite to the connecting portion with the second tubular body, or the second tubular body first. other end opposite to the connection portion between the one tubular body, may further have a third tubular member coupled.

In the medical device of the present invention, as a more specific embodiment,
The main lumen,
An inner layer with a main lumen inside,
On the outer peripheral surface of the inner layer, a reinforcing layer made of a tubular body,
A catheter having at least an outer layer covering an inner layer including a reinforcing layer may be used.

The method of manufacturing a medical device of the present invention includes a melting step of forming the molten portion comprise melting the end portion of the wire material of the first tubular body made of a linear material,
And the molten portion of the first tubular member and an end portion of the wire material of the second tubular body made of a wire material, a contact step of contacting each other,
By connecting the contact portion between the end portion of the wire material of the molten portion and the second tubular body of the first tubular member, and a coupling step of obtaining a tubular body extending longitudinally, only including,
In the connecting step, at least one of the inner peripheral surface of the melting portion of the first tubular body and the inner peripheral surface of the end portion of the second tubular body expands toward the end portion connected to each other. A taper cut portion having a diameter is formed, and the first tubular body and the second tubular body having the end as a boundary are connected so that the bending rigidity is continuous.

Moreover, in the manufacturing method of the medical device of the present invention, as a more specific embodiment, the melting step includes
A cutting step of cutting the melted part at a predetermined position;
And a planarization step of polishing the cut melted portion to form a flat end surface.

Moreover, in the manufacturing method of the medical device of the present invention, as a more specific embodiment, the melting step or the connecting step is:
The method further includes a thinning step of polishing the outer periphery of the melted portion after the melting step or the outer periphery of the connecting portion after the connecting step to reduce the thickness of the first tubular body or the tubular body in the outer diameter direction. May be.

  In the medical device manufacturing method of the present invention, in the connecting step, the melted portion of the first tubular body and the end portion of the second tubular body that are in contact in the contact step are arranged in the circumferential direction. Further, it may include a laser welding process in which the contact portions are melted in a belt shape by a laser and the contact portions are connected.

  Moreover, in the manufacturing method of the medical device of the present invention, as a more specific embodiment, in the connecting step, the melting portion of the first tubular body and the end portion of the second tubular body that are contacted in the contacting step are used. It may include a heat welding process in which the entire outer periphery of the contact portion is melted into a belt shape by resistance welding or heating and the contact portion is connected.

  Moreover, in the manufacturing method of the medical device of the present invention, as a more specific embodiment, the brazing step of brazing the outer periphery of the connecting portion of the first tubular body and the second tubular body connected in the connecting step. May be further included.

  Note that the various components of the present invention do not have to be individually independent, that a plurality of components are formed as one member, and one component is formed of a plurality of members. It may be that a certain component is a part of another component, a part of a certain component overlaps a part of another component, and the like.

  In the present invention, it is possible to freely manufacture a tubular body having various mechanical characteristics, such as changing the winding method or the knitting method of the wire material in the middle. Therefore, it is possible to provide a medical device having a structure that can easily realize desired and different mechanical characteristics, such as a tubular body whose distal end portion is flexible and whose proximal end portion is hard. it can.

It is the schematic showing the connection process with the coiled 1st tubular body and mesh-shaped 2nd tubular body of the medical device concerning 1st embodiment of this invention, (a) is the 1st before connection. It is a top view after cutting of the end of each wire material of a 2nd tubular body after melting of a tubular body, and (b) is grind | polishing after cut | disconnecting the melted part of a 1st tubular body, and flat end surface is obtained. It is a top view which shows the state which formed and polished so that the end of each wire material might be flat and coplanar after cutting the end of each wire material of the 2nd tubular body, and formed the end face in each wire material (C) is a top view which shows the state which contact | abutted the end surface of the 1st tubular body, and each end surface of the wire material of a 2nd tubular body mutually, and was connected by welding. It is the schematic for demonstrating the modification concerning 1st embodiment, and is the schematic showing the edge part of a coil-shaped 1st tubular body of an eight-winding winding, (a) is the end of each wire material before a fusion | melting It is sectional drawing which shows a part, (b) is an end elevation which shows the state which each wire material melt-joined by melting. It is a schematic diagram showing the connection process of the 1st winding coil-shaped 1st tubular body and 2nd tubular body in the medical device concerning 2nd embodiment of this invention, (a) is 1st and 2nd. It is a schematic diagram which shows the state before performing the fusion | melting process and grinding | polishing process of both the edge parts of this tubular body, (b) grind | polishes a melted part by a grinding | polishing process, forms an end surface, and interposes a wax material. (C) is a schematic diagram which shows the tubular main body after a connection process. It is a schematic diagram which shows the tubular main body which has the 1st-3rd tubular body for using for the catheter which is a medical device concerning 3rd embodiment, (a) is a schematic diagram which shows the tubular main body which shows a linear state. And (b) is a schematic diagram showing a state in which the tubular body is bent by pulling an operation line (not shown) and expanding and contracting the second tubular body. It is a side surface schematic diagram explaining operation | movement of the catheter concerning 3rd embodiment of this invention, (a) is a side surface schematic diagram which shows the catheter of a natural state, (b) is the state which pulled the 1st operation line. It is a side surface schematic diagram which shows a catheter, (c) is a side surface schematic diagram which shows the catheter of the state which pulled the 2nd operation line largely. It is a schematic diagram explaining the use condition of the catheter of 3rd embodiment, (a) is a schematic diagram which shows the state which the distal end of the catheter penetrated in the blood vessel reached | attained the bifurcation part of the blood vessel, ( (b) is a schematic diagram showing a state in which the catheter is advanced in a state where the curvature of the distal end of the catheter does not match the branching angle of the vascular branch, and (c) shows the blood vessel by pulling the first operation line. It is a schematic diagram which shows the state which bent the distal end part with the curvature suitable for the branching angle of a branch, and entered the said blood vessel branch, (d) pulls a 2nd operation line, and (c) FIG. 6 is a schematic diagram showing a state where a distal end portion is bent with a curvature that matches a branching direction of a blood vessel branch that branches in a different direction and entered into the blood vessel branch. It is a schematic diagram showing the connection process of the 1st winding coil-shaped 1st tubular body and 2nd tubular body in the medical device concerning 4th embodiment of this invention, (a) is a 1st tubular body. It is a schematic diagram which shows the edge part of the 1st, 2nd tubular body after the fusion | melting process of the edge part of this, and before a planarization process, (b) opposes the wire material of a 1st, 2nd tubular body. (C) is a schematic diagram showing a state in which a joining portion is arranged in a heating furnace through a wax material after performing a flattening step of cutting an end portion and polishing the end portion to form an end face. It is a schematic diagram which shows the tubular main body after a heat welding process and a brazing process. (A)-(d) is a schematic diagram which shows the manufacturing process of the tubular main body of 5th embodiment of this invention. (A) is an enlarged side view near the end surfaces of the first tubular body and the second tubular body of the fifth embodiment, and (b) is an enlarged side view near the connecting portion of the tubular body.

  Hereinafter, a tubular body used for a medical device of the present invention and an embodiment in which the tubular body is applied to a catheter will be described based on the drawings. In all the drawings, the same reference numerals are given to the same components, and the description will be omitted as appropriate.

<First embodiment>
The configuration of the tubular main body 100 used in the medical device according to the first embodiment will be described with reference to FIG. The tubular main body 100 of this embodiment is used by being inserted into a body cavity, and is formed in a long shape having flexibility. The tubular body 100 includes a coil-shaped first tubular body 10 made of the wire material 11a, a melted portion 12 in which ends of the wire material 11a of the first tubular body 10 are integrally melted, and a braided mesh. The end surface 22 of the melted portion 22, which is composed of the formed wire materials 21 a and 21 b and the intersections of the end portions of the wire materials 21 a and 21 b are integrally melted, is connected to the melted portion of the first tubular body 10 via the connecting portion 30. And a second tubular body 20 connected to the 12 end faces 12a . In addition, each end surface 12a, 22a of the 1st tubular body 10 and the 2nd tubular body 20 cut | disconnects the fusion | melting parts 12 and 22 in an appropriate position, and is planarized by grinding | polishing.

  Next, each process of the manufacturing method of the tubular main body 100 of this embodiment is demonstrated using FIG. FIG. 1A shows a state after one end of the coiled first tubular body 10 is appropriately melted and before cutting, and two first wire materials 21a, and These are the top views which show the state before the cutting | disconnection by the side of the edge part of the mesh-like 2nd tubular body 20 formed by braiding the 2nd line | wire 2nd line material 21b which cross | intersects, (b) is (a). At the “cutting position” shown in FIG. 2, the melted portion of the first tubular body 10 and the ends of the wire materials 21a and 21b of the second tubular body 20 are appropriately cut and polished, and the first tubular body 10 is flattened. (C) is a plan view for explaining a flattening process for forming a typical end face and polishing the end portions of the wire materials 21a and 21b of the second tubular body 20 so that they are flat and aligned on the same plane. These are top views for demonstrating the contact process and connection process of the 1st tubular body 10 and the 2nd tubular body 20. FIG.

  The manufacturing process of the tubular main body 100 used for the medical device of the present embodiment includes a melting process, an abutting process, and a connecting process. In this embodiment, the melting process includes a cutting process, a flattening process, and a thinning process, and the connecting process includes a laser welding process and optionally a thinning process. First, the first tubular body 10 and the second tubular body 20 are prepared before the melting step. In this embodiment, as shown to Fig.1 (a), the coiled 1st tubular body 10 formed by winding the wire material 11a and the 1st wire material 21a of a 2 item | strip, and these cross | intersect. A mesh-like second tubular body 20 formed by braiding the two second wire materials 21b is used. The ends of the mutual wire materials 11a, 21a, and 21b are not flat, and it is difficult to connect them as they are.

Therefore, in the melting step, in order to facilitate the connection between the first tubular body 10 and the second tubular body 20, the end of the wire material 11a of the first tubular body 10 as shown in FIG. Adjacent windings of the wire material 11a of the first tubular body 10 are integrated with each other by appropriately melting the part side. The filled portion shown in FIG. 1A is the melting portion 12 of the first tubular body 10. Next, the end portions of the first tubular body 10 and the end portions of the wire materials 21a and 21b of the second tubular body 20 are cut and removed at the respective “cutting positions” indicated by the one-dot chain line in FIG. A cutting step is further performed. In the second tubular body 20, the melting step is not performed and only the cutting step is performed. However, the ends of the wire materials 21 a and 21 b of the second tubular body 20 may be melted and then cut. When melted in this way, the cutting process of the second tubular body 20 becomes easy, the intersections of the wire materials 21a and 21b are welded together, and the connection with the first tubular body 10 becomes easy. There is. Next, in the flattening step, as shown in FIG. 1B, the cut surface of the melting portion 12 of the first tubular body 10 is polished to form a flat end surface 12a. Further, the end portions of the wire materials 21 a and 21 b of the second tubular body 20 are polished to form end surfaces 22 a that are flat and scattered on substantially the same plane. As described above, the end surface is not only the end surface 12a formed in a planar shape like the coil-shaped first tubular body 10, but also the end portions of the wire materials 21a and 21b of the braided second tubular body 20. the cut, polished, each line material 21a, formed at the tip of 21b, the set and the flat end face 22 a dotted on substantially the same plane (virtual plane), the second tubular body 20 be subjected to welding Also included are end faces formed by joining the intersections of the wire materials 21a and 21b, and cutting and polishing the joined portions of the intersections.

  In the melting process, the outer periphery of the melted portion 12 may be uneven, a burr may be generated, and the like, resulting in a thick wall in the outer diameter direction and a rough surface. In that case, the outer periphery of the fusion | melting part 12 may also be grind | polished and the thickness of the outer diameter direction of the 1st tubular body 10 may be made flat and thin (thinning process). In addition, the flattening process and thinning process of the first tubular body 10 may be performed as a series of operations, or the thinning process may be performed after the connecting process described below.

Thus, first, by performing a planarization process to the end portion of the second tubular member 10 and 20, by forming a flat end face 12a, 22 a, a first tubular member 10 of the second The connectivity of the connecting portion 30 with the tubular body 20 can be improved. Further, by performing the flattening step, not only the melting portion 12 of the first tubular body 10 becomes a flat end surface 12a , but also the melting portion 12 becomes thin (narrow) in the length direction. Therefore, it is possible to prevent the connecting portions 30 after being connected from becoming too hard and to connect the first and second tubular bodies 10 and 20 without affecting the flexibility and rigidity of the first and second tubular bodies 10 and 20. Therefore, for example, it is possible to prevent the flexibility from being impaired or the kink resistance of the connecting portion 30 from being lowered.

Next, in the contact process, as shown in FIG. 1 (c), each line material 21a of the end face 12 a and the second tubular body 20 of the first tubular member 10 and an end face 22 a and 21b abut. Then, in the connecting step, the contacted end surfaces 12 a and 22 a are irradiated with laser in the circumferential direction so that the contact portions are welded and connected in a band shape (laser welding step). By completing this connecting step, a single long tubular body 100 is formed. At this time, the outer periphery of the connecting portion 30 formed by welding may not be smooth due to unevenness or burrs. In that case, a thinning step of polishing the outer periphery of the connecting portion 30 may be performed to reduce the thickness in the outer diameter direction and to smooth the outer peripheral surface of the tubular body 100 (thinning step). As described above, the tubular main body 100 is connected to the coil-shaped first tubular body 10 and the mesh-shaped second tubular body 20 having different mechanical characteristics via the coupling portion 30 formed by welding at the time of coupling. Is formed. Therefore, for example, if one tubular body is excellent in rigidity and torque transmission and the other is excellent in flexibility and flexibility, the tubular body 100 has a hardness capable of reliably entering the body cavity. In addition, it has rigidity excellent in torque transmission and can be formed to be bent in the body cavity. Therefore, it is suitable for use in medical devices such as guide wires and catheters. Further, by connecting the plurality of tubular bodies 10 and 20 to form the tubular body 100 as described above, a long product having desired mechanical characteristics can be easily obtained.

  As the raw material of the wire materials 11a, 21a, 21b and the wire materials of the following embodiments, the same kind of metal is preferable. The same kind of metal means, for example, metals that have substantially the same melting point and the like and excellent melt adhesion, as well as the same metal. Specific examples of preferable metal materials include nickel titanium alloys such as stainless steel (SUS) and nitinol (NiTi), steel, titanium, copper alloys, platinum, and tungsten. In addition, this invention is not limited to this, You may form with a resin material. As a preferable resin material, specifically, for example, a fine wire of a polymer fiber such as polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), or the like can be used. Further, for example, the first tubular body 10 may be formed of a resin material, and the first tubular body 10 made of the resin material may be melt bonded to the second tubular body 20 made of metal. Alternatively, the first tubular body 10 may be formed of a metal material, and the second tubular body 20 may be formed of a resin material. Or even if it forms both the 1st tubular body 10 and the 2nd tubular body 20 with a resin material, it will become excellent in the joining property of the 1st, 2nd tubular bodies 10 and 20. FIG. Furthermore, when making a wire material into multiple strips, a metal wire material and a resin wire material may be mixed. The cross-sectional shape of the wire material is not particularly limited, and may be any shape such as a circle, an ellipse, a square, a rectangle, and a polygon.

  Moreover, in this embodiment, although the coiled 1st tubular body 10 and the mesh-shaped 2nd tubular body 20 are used, this invention is not limited to this. For example, both may be coiled tubular bodies, or both may be mesh-like tubular bodies. In the case of a coiled tubular body, the coils may be formed of wire materials having different outer diameters and shapes. Further, the winding pitch of the coil may be changed. For example, a tightly wound coil-shaped tubular body is used for a portion requiring rigidity, and a winding pitch is provided for a portion requiring flexibility. A wide and flexible tubular body may be used. Moreover, even if it is a coil-shaped or mesh-shaped tubular body, the number of both wire materials may be changed. In this case, the melted portions obtained by melting the end portions on both contact sides are cut at appropriate positions and polished to form flat end surfaces, thereby connecting the end surfaces to each other. Therefore, one long tubular body excellent in connectivity can be obtained. These end faces may be perpendicular to the axial direction of the tubular main body 100 as in this embodiment, but the present invention is not limited to this. For example, you may form inclining with respect to the axial direction of the tubular main body 100 (for example, parallel to the winding angle of a coil). Further, the connectivity can be improved by brazing the connecting portion 30 further. Further, for example, when the wire material 21a of the second tubular body 20 is larger than the wire material 11a of the first tubular body 10, the first tubular body 10 portion is relatively flexible and excellent in kink resistance, The second tubular body 20 portion can obtain the tubular body 100 having different mechanical characteristics depending on the site, such as the rigidity and torque transmission being improved, and the possibility that the variation of medical devices used is widened is improved. . Furthermore, in the present embodiment, only the second tubular body is braided in a mesh shape, but the first tubular body may be braided in a mesh shape. Also in this case, at least the wire materials 11a at the end of the first tubular body 10 are welded to form a welded portion, whereby the intersecting intersections of the braids are melt-bonded. The fusion-bonded intersections are discretely arranged around the first tubular body 10. By cutting the melted portion at this end and polishing the end surface, a virtual flat end surface in which the melt-bonded intersections are in the circumferential direction and scattered on substantially the same plane is formed. When the end surface of the wire material of the mesh-like second tubular body or the end surface of the second tubular body is also formed on this end surface, by connecting the end surfaces, it is possible to connect with excellent kink resistance. .

  Moreover, in the connection process of this embodiment, although the end surfaces 12a and 22a which the 1st tubular body 10 and the 2nd tubular body 20 contacted are welded and connected by the laser (laser welding process), this invention is connected. However, it is not limited to this. As another different example, the entire outer periphery of the contacted end faces 12a and 22a may be joined by melting in a belt shape by heating as in resistance welding or a fourth embodiment described later (heating welding process).

  In the present embodiment, the first tubular body 10 is formed in a single-winding coil shape, but as a further different modification, the first tubular body may be formed in a multi-winding coil shape. FIG. 2A shows a cross-sectional view of the end portion of the first tubular body 110 formed by winding the eight wire materials 111 into eight strips. In such a coiled first tubular body 110, when melted in the melting step, as shown in FIG. 2B, end surfaces 112 in which adjacent wire materials 111 are fused and integrated with each other are formed. The The end face 112 and the outer periphery integrated in this way are cut at appropriate positions as necessary, polished and flattened or thinned, and then a coiled or mesh-like second tubular body (not shown). The end surfaces of the wires or the ends of the wire material are brought into contact with each other to be connected by melting or the like. Since the surface area of the end surface 112 is thus increased, the connectivity between the first tubular body 110 and the second tubular body is improved. In addition, the first tubular body 110 and the second tubular body having different numbers and shapes of wire materials can be easily and satisfactorily connected. In particular, when the first tubular body 110 and the second tubular body are both coiled and the diameters of the wire materials are different, both end portions are melted to form end surfaces, and the end surfaces are joined to each other. This is effective because it can be connected by surface contact. As described above, various connections can be made to the connection between the first tubular body 110 and the second tubular body.

<Second embodiment>
Next, the tubular main body 200 used in the medical device according to the second embodiment and the manufacturing process thereof will be described with reference to FIG. In this embodiment, as shown to Fig.3 (a), the coiled 1st tubular body 210 and the 2nd tubular body 220 which were closely wound by 1 line | wire are formed using one wire material 211,221. Has been. In the state of Fig.3 (a), the position of a mutual edge part is uneven and a connection is difficult. Therefore, a melting step is performed to form the melted portions 212 and 222, and then a cutting step is performed to cut the melted portions 212 and 222 to an appropriate length, and then a cut surface is polished by a flattening step. End surfaces 212a and 222a are formed, respectively. Furthermore, you may perform the thinning process which grind | polishes the outer periphery of the fusion | melting parts 212 and 222, and thins the thickness of an outer-diameter direction. Through the above steps, as shown in FIG. 3B, the end surfaces 212a and 222a are flattened to form a shape that can be easily connected, and the outer peripheral surface also becomes smooth.

Then, first, the melted joining end surfaces 212a, 222 a of the melting portion 212 and 222 of the second tubular member 210 and 220, in this case, to enable a more robust connection, the end surface 212, 222 A wax material 240 is arranged between them. Then, after indirectly contacting the end surfaces 212a and 222a of the melting parts 212 and 222 via the wax material 240 (contact process), the circumferential direction is heated and the melting parts 212 and 222 are melt-bonded to each other. Thus, the connecting portion 230 is obtained in which the end faces 212a and 222a of the first and second tubular bodies 210 and 220 are firmly connected via the brazing material 240 (the brazing step and the connecting step).

  In the present embodiment, a wax material 240 is interposed between the end surface 212 a of the first tubular body 210 and the end surface 222 a of the second tubular body 220. However, as a modification, after the end surface 212a of the first tubular body 210 and the end surface 222a of the second tubular body 220 are brought into contact with each other, a wax material 240 may be disposed on the outer periphery thereof and melt-bonded to each other. . When formed in this way, the end faces 212a and 222a are joined together to form the connecting portion 230, and even if there is a gap or the like in the connecting portion 230, the gap is filled with the wax material 240. Effects such as improvement in strength can be obtained.

  Excess wax material 240 (irregularities or burrs) may be removed later by polishing or the like in the thinning process, and smoothing the outer peripheral surface does not affect the inner wall in the body cavity and is smooth. Insertion and entry are possible. In addition, it is preferable to use silver wax as the material of the wax material 240 in consideration of use in medical equipment. However, the present invention is not limited to this, and inexpensive solder or the like may be used depending on the use of the medical device. In the present embodiment, the end faces 212a and 222a are connected by heating, but may be connected by resistance welding or laser (laser welding process, heat welding process, etc.).

<Third embodiment>
Next, the tubular main body 300 used for the catheter as a medical device according to the third embodiment and a manufacturing process thereof will be described with reference to FIGS. 4, 5, and 6. As shown in FIGS. 4A and 4B, the tubular main body 300 of the present embodiment sequentially connects a first tubular body 310, a second tubular body 320, and a third tubular body 360. Is formed. The first tubular body 310 is formed in a coil shape by densely winding a metal wire material 311 in eight or sixteen strips to enhance rigidity and torque transmission. On the other hand, the second tubular body 320 is excellent in elastic force and restoring force because the metal wire material 321 is wound into a four-wire winding through a predetermined gap and formed in a coil shape. As shown in b), it is formed to have good flexibility. On the other hand, the third tubular body 360 is excellent in rigidity, pressure resistance, and the like because the intersecting first and second wire materials 361 (361a, 361b) are finely braided and formed in a mesh shape. By connecting the first, second, and third tubular bodies 310, 320, and 360 through the connecting portion 330 in the steps as in the above-described embodiments, the tubular body 300 having various mechanical characteristics is obtained. Can be easily obtained. The left side (downward in the drawing) of FIG. 4 corresponds to the leading end (hereinafter also referred to as “distal end side DE”), and the right side (upward in the drawing) corresponds to the proximal side (hereinafter referred to as “base end side”) or (Also referred to as “proximal end CE”). However, the illustration of the proximal end CE is omitted in FIG. In the present embodiment, the first to third tubular bodies 310, 320, and 360 are connected, but a fourth or more tubular bodies may be further connected, and variations in mechanical characteristics are different. A rich tubular body 300 can be obtained. In other embodiments as well, third or more tubular bodies may be connected.

  By using the tubular main body 300 as in the present embodiment, the third tubular body 360 having a mesh shape and excellent pressure resistance is disposed on the distal end side. Insertion and advancement into the body cavity is facilitated without being crushed. Further, the second tubular body 320 continuous with the third tubular body 360 is excellent in flexibility, and can be easily inserted into various branched blood vessels by free bending as described later. In addition, because it is excellent in flexibility, it also has excellent kink resistance, prevents the lumen from being crushed, and restores the original shape even when bent, allowing it to flex freely in other directions and curvatures Can do. Furthermore, since the first tubular body 310 that is on the hand side and continues to the second tubular body 320 is formed in close winding, the first tubular body 310 is excellent in rigidity, and the sheath 470 described later can be smoothly advanced. The torque transmission is excellent, and the sheath 470 can be quickly and accurately rotated in a desired direction.

  Next, the configuration of the catheter 400 using the tubular body 300 as described above will be described with reference to FIG. The catheter 400 of this embodiment includes a main lumen (not shown), an inner layer 476 having a main lumen inside, a reinforcing layer (not shown) made of the tubular body 300 on the outer peripheral surface of the inner layer 476, A sheath 470 having an outer layer (not shown) covering the inner layer 476 including the reinforcing layer and a coat layer (not shown) covering the surface of the outer layer is provided. FIG. 5 schematically shows respective portions of the first, second, and third tubular bodies 310, 320, and 360. In addition, a ring-shaped marker (not shown) made of platinum or the like is disposed on the distal end DE of the inner layer 476. The outer layer is smaller in diameter than the main lumen and spaced 180 degrees around the main lumen. A pair of sub-lumens 471a and 471b arranged opposite to each other are provided.

  Further, two operation lines (first operation line 472a and second operation line 472b) are slidably inserted through the sub-lumens 471a and 471b. The first and second operation lines 472a and 472b are the distal end DE of the catheter 400, and the tip (hereinafter referred to as “distal end 473 (473a, 473b)”) is fixed to the marker. Has been. Further, the other tip of each operation line 472a, 472b (hereinafter referred to as “proximal end 474 (474a, 474b)”, see FIG. 5) is fixed to the proximal end portion 416, and this proximal end portion 416 is fixed. By pulling, the second tubular body 320 portion is bent at the distal end portion 415 of the catheter 400 as shown in FIGS.

  As shown in FIG. 5, the distal end 415 of the catheter 400 refers to a predetermined length region including the distal end DE of the catheter 400. Similarly, the proximal end portion 416 of the catheter 400 refers to a predetermined length region including the proximal end side PE of the catheter 400. The bending of the catheter 400 means that part or all of the catheter 400 is bent or bent. And the catheter 400 of this embodiment has the 2nd tubular body 320 arrange | positioned as shown in FIG. 5 by selection of the operation line to pull (the 1st operation line 472a or the 2nd operation line 472b). The curvature C (C1, C2) of the distal end portion 415 that is bent at the position changes in a plurality of ways. Details of this refraction will be described later.

  As shown in FIG. 5, the catheter 400 has an operation portion 480 for pulling the first operation line 472 a and the second operation line 472 b individually to bend the distal end portion 415 of the catheter 400. Proximal end 416 is provided.

  The operation unit 480 includes a shaft portion 481 extending in the longitudinal direction of the catheter 400, sliders 484a and 484b that respectively advance and retract in the longitudinal direction of the catheter 400 with respect to the shaft portion 481, a handle portion 482 that rotates the shaft portion 481 about an axis, And a grip portion 483 through which the sheath 470 is rotatably inserted. Further, the proximal end portion 416 of the sheath 470 is fixed to the shaft portion 481. Further, the handle portion 482 and the shaft portion 481 are integrally formed. Then, by rotating the grip portion 483 and the handle portion 482 relative to each other, the entire sheath 470 including the operation lines 472a and 472b rotates together with the shaft portion 481. Since the first tubular body 310 having high rigidity is disposed at the proximal end portion 416, the proximal end portion 416 is excellent in torque transmission and can perform excellent torque rotation.

  Therefore, the operation unit 480 of this embodiment is a member that rotates the distal end 415 of the sheath 470. In the present embodiment, a handle portion 482 as a rotation operation portion for rotating the sheath 470 by torque and a slider 484 as a bending operation portion for bending the sheath 470 are integrally provided.

  The proximal end 474a of the first operation line 472a protrudes from the proximal end 416 of the sheath 470 to the proximal end side, and is connected to the slider 484a of the operation unit 480. Similarly, the proximal end 474b of the second operation line 472b is also connected to the slider 484b of the operation unit 480. Then, the slider 484 a and the slider 484 b are individually slid toward the proximal end side with respect to the shaft portion 481, whereby the first operation line 472 a or the second operation line 472 b connected thereto is pulled and the distal end of the sheath 470 is pulled. A tensile force is applied to the end 415. Thereby, the distal end portion 415 in which the second tubular body 320 is disposed on the pulled operation lines 472a and 472b is bent.

  Here, the material of each part of the sheath 470 will be described. As a material of the inner layer 476, for example, a fluorine-based thermoplastic polymer can be used. More specifically, resin materials such as polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), and perfluoroalkoxy fluororesin (PFA) can be used. As described above, by using a fluorine-based resin for the inner layer 476, the delivery property when supplying a contrast medium or a drug solution to the affected area through the main lumen of the catheter 400 is improved.

  For example, a thermoplastic polymer is widely used as the material of the outer layer. Examples include PI, PAI, PET, polyethylene (PE), polyamide (PA), nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA), polyvinyl chloride (PVC), polypropylene (PP), etc. These resin materials can be used.

  In addition, a coat layer (not shown) is provided on the surface of the outer layer as necessary. As the material of the coat layer, for example, a hydrophilic resin material such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone is used. be able to.

  Various methods can be employed for inserting the operation lines (first operation line 472a and second operation line 472b) into the sub-lumens 471a and 471b, respectively. The first and second operation lines 472a and 472b may be inserted from one end side of the sheath 470 of the catheter 400 that is formed through the sub-lumens 471a and 471b in advance. Alternatively, when the sheath 470 is extruded, the first and second operation lines 472a and 472b may be extruded together with the resin material and inserted into the sub-lumens 471a and 471b.

  When the first and second operation lines 472a and 472b are extruded together with the resin material and inserted into the sub-lumens 471a and 471b, the first and second operation lines 472a and 472b have a melting temperature higher than the melting temperature of the resin material constituting the sheath 470. Heat resistance is required. In the case of the first and second operation lines 472a and 472b, specific materials include, for example, polyether ether ketone (PEEK), polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), PI or PTFE, and the like. Molecular fibers or metal wires such as SUS, corrosion-resistant coated steel wires, titanium or titanium alloys can be used. On the other hand, when the first and second operation lines 472a and 472b are inserted into the sub-lumens 471a and 471b of the sheath 470 formed in advance, the first and second operation lines 472a and 472b are not required to have heat resistance. In some cases, PVDF, high density polyethylene (HDPE), polyester, or the like can be used in addition to the above materials.

  In the present embodiment, a pair of sub-lumens 471a and 471b are formed inside the outer layer. In the catheter 400 of this embodiment, the sub-lumens 471a and 471b through which the first and second operation lines 472a and 472b are inserted are formed outside the tubular body 300 as a reinforcing layer. Sublumens 471a and 471b are provided along the longitudinal direction of the catheter 400 (the left-right direction in FIG. 5), and at least the proximal end 416 of the catheter 400 is open. As described above, in this embodiment and the following embodiments, the sub-lumens 471a and 471b are formed outside the tubular main body 300, but the present invention is not limited to this. For example, after forming the sub-lumens 471a and 471b on the outer side of the inner layer 476, the tubular main body 300 may be disposed on the outer periphery of the sub-blooms 471a and 471b.

  Here, by providing the sub-lumens 471a and 471b through which the first and second operation lines 472a and 472b are spaced apart from the main lumen, when supplying a medicine or the like through the main lumen or inserting the optical system These do not leak into the sub-lumens 471a and 471b. Then, by providing the sub-lumens 471a and 471b on the outside of the tubular main body 300 as in the present embodiment, the inside of the tubular main body 300, that is, the main lumen with respect to the operation lines 472a and 472b sliding in the sheath 470 is provided. Protected. For this reason, even if the first and second operation lines 472a and 472b are disengaged from the distal end portion 415 of the catheter 400, the first and second operation lines 472a and 472b may tear the peripheral wall of the main lumen. There is no.

  The distal ends 473 a and 473 b of the first and second operation lines 472 a and 472 b are fixed to the distal end 415 of the catheter 400. The aspect in which the distal ends 473a and 473b of the first and second operation lines 472a and 472b are fixed to the distal end 415 is not particularly limited. In the present embodiment, as described above, the distal ends 473a and 473b of the first and second operation lines 472a and 472b are fastened to the marker. Alternatively, it may be welded to the distal end 415 of the sheath 470, or may be adhesively fixed to the distal end 415 of the marker or sheath 470 with an adhesive.

  When the proximal ends 474a and 474b of the operation line (the first operation line 472a or the second operation line 472b) as described above are pulled, a tensile force is applied to the distal end portion 415 of the catheter 400, and the first A part or all of the distal end portion 415 where the second tubular body 320 is located is bent toward the pulled side of the sub-lumens 471a and 471b through which the operation line 472a or the second operation line 472b is inserted. . On the other hand, when the proximal ends 474a and 474b of the first and second operation lines 472a and 472b are pushed into the catheter 400, the distal end of the catheter 400 from the first and second operation lines 472a and 472b. The pushing force is not substantially applied to the portion 415.

  In the catheter 400 of this embodiment, the operation line to be pulled is only the first operation line 472a, only the second operation line 472b, or the two first and second operation lines 472a and 472b. The curvature C of the bent distal end 415 changes in a plurality of ways depending on whether the two are pulled simultaneously. Thereby, the catheter 400 can be freely entered into a body cavity that branches at various angles.

  Further, as shown in FIG. 5, the catheter 400 of the present embodiment is obtained when the proximal ends 474a and 474b of the two operation lines (first operation line 472a or second operation line 472b) are individually pulled. The curvatures (C1, C2) of the distal end 415 are different from each other. Specifically, as shown in FIGS. 5B and 5C, the second operation line 472b is greatly pulled compared to the curvature C1 of the distal end portion 415 when the first operation line 472a is pulled. In some cases, the curvature C2 of the distal end 415 is greater.

  Hereinafter, typical dimensions of the catheter 400 of the present embodiment will be described. The radius of the main lumen is preferably about 200 to 300 μm, the thickness of the inner layer 476 is about 10 to 30 μm, the thickness of the outer layer is about 100 to 150 μm, and the thickness of the tubular body 300 as the reinforcing layer is preferably 20 to 100 μm. . The length from the axial center of the catheter 400 to the centers of the sublumens 471a and 471b is about 300 to 400 μm, the inner diameters of the sublumens 471a and 471b are 40 to 100 μm, and the first and second operation lines 472a and 472b are thick. The thickness is preferably 30 to 60 μm. And it is preferable to make the outermost diameter of the catheter 400 into about 350-450 micrometers.

  That is, the outer diameter of the catheter 400 of the present embodiment is preferably less than 1 mm in diameter, and can be inserted into blood vessels such as the celiac artery. In addition, the catheter 400 of the present embodiment is operated freely by pulling the first and second operation lines 472a and 472b, so that the catheter 400 is advanced in a desired direction even in a branching blood vessel, for example. It is possible.

  An example of bending the catheter 400 as described above will be described with reference to FIG. For example, as shown in FIG. 5B, when the first operation line 472a is pulled by the slider 484a, a tensile force is applied to the distal end portion 415 of the catheter 400 (that is, the distal end side DE of the sheath 470). As a result, the distal end portion 415 is bent at the curvature C1, for example, in the direction of the pulled first operation line 472a.

  Similarly, as shown in FIG. 5C, when the second operation line 472b is pulled by the slider 484b, the distal end DE of the catheter 400 is bent in the direction with the curvature C2. At this time, a pulling force is applied to the distal end portion 415 of the catheter 400 by pulling the slider 484b more than pulling the first operation line 472a. Thereby, the distal end portion 415 is bent at the curvature C2, for example, in the direction of the pulled second operation line 472b.

As described above, when either the first operation line 472a or the second operation line 472b is individually pulled, the curvature of the distal end portion 415 can be changed according to the distance to be pulled. If the distal end 415 of the catheter 400 cannot be bent to a desired posture by simply pulling the first and second operation lines 472a and 472b, the first and second operation lines 472a, By pulling 472b at the same time, the desired posture of the distal end 415 can be realized.

  In this way, the distal end portion 415 is bent into various shapes, and the rotational phase of the sheath 470 is adjusted by a rotation operation with respect to the handle portion 482. By this operation, the bending amount and the bending direction of the distal end portion 415 can be adjusted, and the catheter 400 can freely enter the body cavity that branches at various angles. Therefore, for example, the catheter 400 of the present embodiment can be advanced in a desired direction even for a branched blood vessel or a peripheral blood vessel. In addition, in the catheter 400 of this embodiment, it is preferable that the bending angle of the distal end part 415 exceeds 90 degrees. Thereby, even if it is a case where the branch angle of a blood vessel is an acute angle which makes a U-turn, the catheter 400 can be advanced with respect to this branch branch.

  Next, an example of the usage state of the catheter 400 according to the present embodiment will be described with reference to the schematic diagrams of FIGS. FIG. 6A shows a state where the distal end DE of the catheter 400 inserted into the blood vessel (A) has reached the bifurcation (B) of the blood vessel (A). Since the third tubular body 360 having excellent pressure resistance and the like is disposed on the distal end side DE side, it is possible to smoothly reach the target position without being pushed back by blood flow or the like. Here, an attempt is made to advance the catheter 400 in the direction x indicated by the arrow in the figure from the branch (b) toward the blood vessel branch (d).

  Therefore, as shown in FIG. 6A, the proximal end 474a of one of the operation lines (first operation line 472a) of the catheter 400 is pulled, and the distal end 415 is bent in the direction x with a curvature C1. Let's say. However, when the first operation line 472a is pulled and the curvature C1 of the distal end portion 415 does not match the branch angle of the blood vessel branch (d), as shown in FIG. ), The distal end 415 is folded in half. When the catheter 400 is pushed into the main tube (e) in this state, the catheter 400 may travel in the direction y corresponding to the extension of the main tube (e).

  Here, it is assumed that the blood vessel branch (d) is branched with a curvature smaller than the curvature C1 with respect to the main pipe (e). Therefore, in the catheter 400 of this embodiment, by adjusting the pulling amount of the first operation line 472a, as shown in FIG. 6 (c), the distal end has a curvature adapted to the branch angle of the blood vessel branch (d). The portion 415 can be bent. As a result, as shown in FIG. 6C, the distal end 415 is inserted sufficiently deep into the blood vessel branch (d) so that the entire catheter 400 can be made to follow this. . Alternatively, the rotational phase of the sheath 470 may be adjusted by a rotation operation with respect to the handle portion 482, and the distal end portion 415 may be bent at the curvature C2 by pulling the second operation line 472b. Also in this case, the second tubular body 320 excellent in flexibility and flexibility can be bent with a free curvature.

  If the desired curvature is not achieved even when one of the first and second operation lines 472a and 472b is individually pulled, the other second and first operation lines 472b and 472a are pulled and the curvature is pulled. May be adjusted. More specifically, in the case of the catheter 400 of the present embodiment in which the first operation line 472a and the second operation line 472b are disposed to face each other by 180 degrees in the radial direction of the sheath 470, two first and second operation lines are provided. By pulling both 472a and 472b, the curvature of the distal end portion 415 is reduced as compared with the case where only one of the first operation line 472a or the second operation line 472b is pulled. Thereby, the operator can bend the distal end portion 415 with a desired curvature by adjusting the pulling amounts of the sliders 484a and 484b of the operation portion 480.

  In addition, as shown in FIG. 6D, when the catheter 400 is advanced from the main tube (e) to the vascular branch (to) branching with a larger curvature than the vascular branch (d), the second operation line 472b is used. The proximal end 474b may be pulled in a state in which is aligned with the branch direction. Alternatively, the first operation line 472a may be pulled by adjusting the rotation phase of the sheath 470 by a rotation operation with respect to the handle portion 482. Also in this case, the first tubular body 310 having excellent rigidity is excellent in torque transmission during rotation and enables smooth and quick rotation. In addition, the bending may be finely adjusted by pulling both the first operation line 472a and the second operation line 472b. In either case, the distal end 415 of the catheter 400 bends with a suitable curvature and can be easily advanced into the vessel branch.

  Thereby, the advancing direction of the entire catheter 400 can be changed from the extending direction y of the main tube (e) to the extending direction z of the blood vessel branch (to). Then, by causing the distal end 415 of the catheter 400 to enter the vascular branch (f) at a sufficient depth, the entire catheter 400 is allowed to enter the vascular branch (f) by following the distal end 415. Can do.

  In addition, due to the presence of the second tubular body 320 of the tubular body 300, even if the distal end portion 415 is bent at a steep angle, problems such as collapse of the main lumen and folding of the catheter 400 in half occur. Can be prevented. Therefore, the smoothness of the lumen of the main lumen can be maintained, and a contrast medium, a drug solution, an endoscope, and the like can be smoothly supplied to the affected area.

  The above is an operation example of the catheter 400 according to the present embodiment. Here, the tubular body 300 generally has improved flexibility and excellent flexibility due to the presence of the second tubular body 320, but has lower torque transmission than tube materials. However, in the present embodiment, as described above, the proximal side of the tubular main body 300 is the tightly wound first tubular body 310, which is excellent in rigidity. Therefore, it is possible to realize the catheter 400 that is excellent in torque transmission without sacrificing flexible flexibility, and allows the catheter 400 according to the present embodiment to freely enter the vascular branch that branches at various branch angles. Therefore, the catheter 400 having excellent blood vessel selectivity can be provided.

  The present invention is not limited to the above-described embodiment, and includes various modifications and improvements as long as the object of the present invention is achieved.

  For example, in addition to changing the type of the tubular body of the tubular body 300, the distal end 415, the proximal end 416, the inner layer 476 or the outer layer of the intermediate portion thereof are formed of different resin materials, The rigidity and flexibility of the part may be changed. Further, by changing the winding pitch of the second tubular body 320 of the tubular main body 300, the rigidity and flexibility of each part may be changed. Furthermore, fourth, fifth, or more tubular bodies having different mechanical characteristics may be connected. Moreover, you may arrange | position the tubular body with the same mechanical characteristic through a suitable arrangement | positioning space | interval. In this embodiment, the flexibility is improved by widening the winding pitch of the wire material 321 of the second tubular body 320 of the distal end 415. Further, since the proximal end portion 416 is provided with the first tubular body 310 around which the wire material 311 is wound so that adjacent windings are in close contact with each other, the rigidity is improved. For example, the fourth tubular body in which the wire material is wound at a winding pitch narrower than the winding pitch of the second tubular body 320 in the intermediate portion between the first tubular body 310 and the second tubular body 320. By connecting the bodies, the flexibility of the distal end 415 and the rigidity of the proximal end 416 can be harmonized. By forming the tubular main body 300 with such a configuration, the distal end portion 415 can be bent freely and smoothly without impairing the flexibility and rigidity of each part. In addition, the smoothness of the main lumen can be maintained.

  In the present embodiment, a pair (two) of sub-lumens 471a and 471b are provided in the sheath 470 so as to face each other at an interval of 180 degrees, and the first and second operation lines 472a and 472b are inserted through the sheaths 470, respectively. However, the present invention is not limited to this. Three or more sublumens may be provided in the sheath 470 at equiangular intervals. For example, when three sub-lumens are provided at equiangular intervals (120-degree intervals), the distal end portion is excellent in torque transmission by operating three operation lines and at a fine angle in the target direction. Can be bent. Three or more sublumens may be provided randomly in the circumferential direction. As described above, providing at random means that it is not provided at an exact equiangular interval as described above, but may cause a slight angle shift as long as it is dispersed in the circumferential direction as a whole. is there. In any case, the sheath 470 can be bent in the direction of the operation line or the intermediate direction of the two or more operation lines by selecting and pulling any one or more operation lines. it can.

  As described above, in the catheter 400 of the present embodiment, the distal end portion 415 has excellent pressure resistance and rigidity, good penetration into the blood vessel, and other than the distal end portion 415 is flexible and flexible. The distal end 416 and the proximal end 416 are different mechanically, such as the rigidity of the proximal end 416 is high and the torque transmission from the proximal end 416 to the distal end 415 is excellent. It is possible to easily and freely realize the characteristics. As a result, for example, it is possible to provide a catheter excellent in blood vessel selectivity that can freely enter a blood vessel that branches at various angles.

  Moreover, although the said embodiment is implemented about the catheter, this invention is not limited to the above-mentioned embodiment, It uses by inserting in a body cavity, such as a guide wire, an endoscope, and an ultrasonic instrument. It can also be applied to other long medical devices. The same applies to the first, second, and fourth embodiments.

<Fourth embodiment>
Next, the tubular main body 500 used in the medical device according to the fourth embodiment and the manufacturing process thereof will be described with reference to FIG. In each said embodiment, the 1st or 2nd tubular body was cut | disconnected by the surface, and the end surfaces or the end surfaces and the edge part of the wire material were melt-joined. However, in this embodiment, the end portions of the wire material are polished to form end surfaces, the end surfaces are melt-bonded to each other, and windings are continuous to obtain a single long tubular body.

  Details will be described below. As shown to Fig.7 (a), in this embodiment, the coil-like 1st tubular body 510 and the 2nd tubular body 520 which were closely wound by 1 line | wire using one wire material 511,521 are used. Used. And as shown to Fig.7 (a), the fusion | melting part 512,522 is formed by fuse | melting a net part by a melting process. However, in the current state, the positions of the end portions of the wire materials 511 and 521 are inconsistent and it is difficult to connect the windings. Therefore, a flattening process is performed, and as shown in FIG.7 (b), the position of the edge part of the mutual wire materials 511 and 521 corresponds, and the 1st, 2nd tubular bodies 510 and 520 are connected continuously. The flat end surfaces 512a and 522a are formed by cutting to a length that is easy to perform and polishing. In the present embodiment, not only the end faces 512a and 522a of the wire materials 511 and 521 but also the adjacent contact portions 512b and 522b of the winding are melt-bonded. Therefore, in order to facilitate joining, the surfaces of the winding contact portions 512b and 522b may be polished to form flat end surfaces (512b and 522b).

Next, as shown in FIG. 7B, the first and second tubular bodies 510 and 520 are inserted into an apparatus that can be heated from the outside, such as the heating furnace 550, and are not shown. but first, the end face 512 a, 522 a and the abutting portion reserved for the winding of the second tubular member 510, 520 (end surface) 512b, a contact with each other 522b (abutting step), the outer periphery of the contact portion of one another Further, a ring-shaped wax material 540 is disposed. And by heating from outside by the heating furnace 550, to each other of the end faces 512 a, 522 a and winding end faces 512b, melt bonded to 522b (heating welding process). Furthermore, it brazes with the brazing material 540 (brazing process), the connection part 530 (530a, 530b) is formed, and the tubular main body 500 is formed (connection process). By brazing, when there is a gap in the connecting portion 530 (530a, 530b) between the first tubular body 510 and the second tubular body 520, the gap is filled and the connection strength of the connecting portion 530 is improved. To do. In this way, the end faces 512 a and 522 a and the winding end faces 512 b and 522 b are not only welded to form the connecting portion 530 but also brazed with the brazing material 540, thereby further increasing the connecting strength of the connecting portion 530. Can be improved. In addition, since both the first and second tubular bodies 510 and 520 are closely wound coils, a long tubular body 500 having high rigidity and the same mechanical characteristics can be obtained. Furthermore, since the connection strength is also high, the long tubular body 500 can be used for products that require excellent torque transmission.

  In the present embodiment, the first and second tubular bodies 510 and 520 having the same mechanical characteristics are connected, but the present invention is not limited to this. A tubular body such as a coil that is wound not by close winding but through a gap may be used. Thereby, the tubular main body 500 from which a mechanical characteristic differs can be obtained.

In the first, second, and fourth embodiments, the melting portions 12, 212, and 512 are annular melting portions that form a ring extending around each of the first tubular bodies 10, 210, and 510. Here, that the melted portion is annular means that a plurality of continuous linear or discrete dotted regions are provided over substantially the entire circumference of the first tubular body. The melting portions 22, 222, and 522 of the second tubular bodies 20, 220, and 520 are also annular melting portions that form an annular shape around the second tubular body.
And in 1st, 2nd, 4th embodiment, the axial direction of these annular fusion parts (melting part 12, 212, 512) and the axial direction of the 1st tubular bodies 10, 210, and 510 are the same. They are parallel to each other. Similarly, the axial direction of the melting parts 22, 222, 522 and the axial direction of the second tubular bodies 20, 220, 520 are parallel.

Thus, the axial dimension of the connection parts 30 , 230, and 530 in the tubular main bodies 100 , 200, and 500 by substantially matching the axial direction of the annular melting part and the axial directions of the first and second tubular bodies ( it is possible to shorten the width), the tubular body 100, the bending stiffness of 200, 500 is hard Re I of loss.

<Fifth embodiment>
In the present invention, instead of the first, second, and fourth embodiments, the melting part may be formed in an oblique annular shape.

  FIGS. 8A to 8D are schematic views showing the manufacturing process of the tubular main body 600 of the present embodiment. FIG. 5A is a partially cutaway side view of the first tubular body 610 and the second tubular body 620. The notch line is shown as a two-dot line. FIG. 4B is a side view of the first tubular body 610 and the second tubular body 620 in which the annular melting portions 613 and 623 are formed. FIG. 5C is a side view of the first tubular body 610 and the second tubular body 620 showing a state where the annular melting portions 613 and 623 are cut and polished. FIG. 4D is a side view of a tubular main body 600 formed by joining the end faces of the annular melting portions 613 and 623.

  The first tubular body 610 is a so-called multi-strand coil formed by spirally winding a plurality of metal wire materials 611. Similarly, the second tubular body 620 is a multi-strand coil formed by spirally winding a plurality of metal wire materials 612. The number of strips of the first tubular body 610 (the number of wire materials 611) is smaller than the number of strips of the second tubular body 620. The wire materials 611 and 612 are so-called round wires whose cross-sectional shape is substantially circular. The diameter of the wire material 611 of the first tubular body 610 is smaller than the diameter of the wire material 612 of the second tubular body 620.

  As shown in FIG. 8A, the angle θ1 formed by the normal direction N1 perpendicular to the spiral direction of the wire material 611 in the first tubular body 610 and the axial direction AX1 of the first tubular body 610 is expressed as follows: The winding angle of the wire material 611 is used. Similarly, the angle θ2 formed by the normal direction N2 perpendicular to the spiraling direction of the wire material 612 in the second tubular body 620 and the axial direction AX2 of the second tubular body 620 is the winding angle of the wire material 612. To do. As the winding angles θ1 and θ2 are larger, the traveling direction of the wire materials 611 and 612 lies down with respect to the axial directions AX1 and AX2. The minimum values of the angles θ1 and θ2 are greater than zero degrees, and the maximum value is less than 90 degrees.

  In the present embodiment, the winding angle θ2 of the second tubular body 620 is larger than the winding angle θ1 of the first tubular body 610.

  From the above, when the Young's modulus of the wire materials 611 and 612 is the same and the winding pitches of the first tubular body 610 and the second tubular body 620 are equal, the bending rigidity of the second tubular body 620 is the first. It becomes larger than the bending rigidity of one tubular body 610.

  As shown in FIG. 8A, the inner diameter ID1 of the first tubular body 610 and the inner diameter ID2 of the second tubular body 620 are equal, that is, substantially the same diameter. In the present embodiment, since the wire material 612 of the second tubular body 620 is thicker than the wire material 611 of the first tubular body 610, the outer diameter OD2 of the second tubular body 620 is the first tubular body. It is larger than the outer diameter OD1 of the body 610.

  FIG. 8B shows a state in which the annular melting portions 613 and 623 are individually formed around the first tubular body 610 and the second tubular body 620. The annular melting portions 613 and 623 can be formed by melting and integrating adjacent spiral loops in the wire materials 611 and 612 by laser irradiation or the like. By irradiating the laser irradiation spot in a ring shape inclined obliquely with respect to the axial directions AX1 and AX2 of the first tubular body 610 and the second tubular body 620, the annular melting portion of this embodiment is irradiated. 613 and 623 can be formed. A circular pattern shown in FIG. 8B shows a laser irradiation mark 615.

  Hereinafter, the angle θ3 formed by the normal direction N3 of the annular melting portion 613 and the axial direction AX1 of the first tubular body 610 is referred to as a ring inclination angle of the first tubular body 610. Similarly, an angle θ4 formed by the normal direction N4 of the annular melting portion 623 and the axial direction AX2 of the second tubular body 620 is referred to as a ring inclination angle of the second tubular body 620.

  The ring inclination angle θ3 of the first tubular body 610 and the ring inclination angle θ4 of the second tubular body 620 are greater than zero degrees and less than 90 degrees. In other words, the axial center direction (normal direction N3) of the annular melting portion 613 and the axial direction AX1 of the first tubular body 610 intersect each other at an intersection angle of less than 90 degrees. And the axial direction (normal direction N4) of the annular fusion part 623 and the axial direction AX2 of the second tubular body 620 intersect each other at an intersection angle of less than 90 degrees.

  More specifically, the intersection angle (ring inclination angles θ3, θ4) is preferably 15 degrees or greater and 45 degrees or less. By setting the crossing angle to 45 degrees or less, the bending rigidity between the first tubular body 610 and the second tubular body 620 becomes continuous with the connecting portion 630 (see FIG. 8D) as a boundary. Become. Moreover, the axial dimension (width dimension) of the connection part 630 does not become excessive by making this intersection angle 15 or more.

  Here, as in the present embodiment, the axial center direction (normal direction N1) of the annular melting portion 613 and the axial direction AX1 of the first tubular body 610 are nonparallel, and the circumferential direction of the annular melting portion 613 is the axial direction. By including the AX1 component, there is an advantage that the winding pitch of the multiple first tubular bodies 610 is not easily changed in the laser welding process. This is remarkable in the first tubular body 610 of pitch winding in which adjacent windings are slightly separated (for example, at an interval less than the wire diameter of the wire material 611). The same applies to the second tubular body 620. Thereby, it is possible to suppress the occurrence of global undulations in the tubular body 600 created according to the present embodiment.

  FIG. 8C shows a state in which the annular melted portions 613 and 623 are arbitrarily cut at an intermediate portion of the width dimension and polished to flatten the end faces 614 and 624.

  FIG. 8 (d) is formed by joining the first tubular body 610 and the second tubular body 620 by joining the end surfaces 614 and 624 to each other with the annular melting portions 613 and 623 in contact with each other. A tubular body 600 is shown. Such bonding can also be performed by laser irradiation. By this laser irradiation, the annular melted portions 613 and 623 are melted to form a new annular melted portion 633. The annular melting portion 633 is formed so as to overlap with the annular melting portions 613 and 623. The connecting portion 630 includes annular melting portions 613, 623, and 633.

  In the tubular body 600 created according to the present embodiment, the inner diameter of the melting portion (annular melting portion 613) of the first tubular body 610 and the inner diameter of the end portion (annular melting portion 623) of the second tubular body 620 are as follows. equal. Here, the inner diameter is a diameter dimension of the inner peripheral surfaces of the annular melting portions 613 and 623 when viewed in the axial direction AX1 of the first tubular body 610 and the axial direction AX2 of the second tubular body 620.

  Since the inner diameter ID1 of the first tubular body 610 and the inner diameter ID2 of the second tubular body 620 are the same diameter, according to the tubular body 600 of the present embodiment, the melting portion (annular shape of the first tubular body 610) The inner peripheral surface of the melting part 613) and the inner peripheral surface of the end part (annular melting part 623) of the second tubular body 620 are continuously formed. Thus, for example, when the tubular body 600 is used around the main lumen of the catheter, the distance between the inner peripheral surface of the tubular body 600 and the main lumen is set to the first tubular body 610 and the second tubular body. The body 620 can be equalized. When the bending rigidity on the distal end side of the catheter is suppressed more than the bending rigidity on the proximal end side, the first tubular body 610 is disposed on the distal end side, and the second tubular body 620 is disposed on the proximal end side.

  The tubular body 600 of this embodiment will be described in more detail. FIG. 9A is an enlarged side view of the vicinity of the end surfaces 614 and 624 of the first tubular body 610 and the second tubular body 620. FIG. 5B is an enlarged side view of the vicinity of the connecting portion 630 of the tubular main body 600. Part or all of the cross-sections of the wire materials 611 and 612 included in the annular melted portions 613 and 623 are melted so as to be stunned with the annular melted portions 613 and 623. Cross sections of the wire materials 611 and 612 are indicated by broken lines.

  By polishing the end surfaces 614 and 624 of the annular melting portions 613 and 623 formed in an annular shape oblique to the axial directions AX1 and AX2, a part of the periphery of the annular melting portions 613 and 623 is like the tip of a bamboo basket. Become sharp. Specifically, of the annular melted portions 613 and 623, the tips that protrude most in the axial directions AX1 and AX2 are sharp. A blunt head 617 is formed at the sharp end of the annular melted portion 613 of the present embodiment so that an unexpected defect does not occur at the sharp tip. Here, the radius of curvature of the blunt head 617 is preferably smaller than the wire material 611 of the first tubular body 610. Similarly, a blunt head 627 is formed at the sharp end of the annular melted portion 623. The radius of curvature of the blunt head 627 is smaller than the wire material 612 of the second tubular body 620. The strength of the first tubular body 610 and the second tubular body 620 can be maintained by making the radius of curvature smaller than that of the wire materials 611 and 612 so that the blunt heads 617 and 627 are not excessive. The blunt heads 617 and 627 can be formed by R processing of the annular melted portions 613 and 623.

  As shown in FIG. 9A, the inner peripheral surface of the melting portion (annular melting portion 613) of the first tubular body 610 or the inner peripheral surface of the end portion (annular melting portion 623) of the second tubular body 620. Tapered cut portions 616 and 626 are formed on at least one (both in the present embodiment). As shown in FIG. 9B, the taper cut portions 616 and 626 have a truncated cone shape whose diameter increases toward end portions (end surfaces 614 and 624) connected to each other in the tubular body 600. By providing the taper cut portions 616 and 626, the thickness of the annular fusion portions 613 and 623 continuously decreases toward the end surfaces 614 and 624. Thereby, the tubular main body 600 of the present embodiment is configured such that the bending rigidity between the first tubular body 610 and the second tubular body 620 with the end portions (end surfaces 614 and 624) as a boundary is continuous. Yes.

  The tapered cut portions 616 and 626 have a maximum diameter at the end surfaces 614 and 624. In the present embodiment, the diameters of the tapered cut portions 616 and 626 on the end faces 614 and 624 are equal to each other. Accordingly, the annular melting portions 613 and 623 can be fused and integrated with each other in a state where the end surfaces 614 and 624 are in good contact with each other, whereby the connecting portion 630 can be formed.

Various combinations of the present invention are possible. For example, in the tubular main body 600 of the fifth embodiment, the outer periphery of the annular melting portions 613 and 623 or the connecting portion 630 may be polished to make these portions thinner. Thereby, the bending rigidity of the distal end side and the proximal end side of the tubular main body 600 can be made as continuous as possible with the connecting portion 630 as a boundary.
Examples of reference forms are shown below.
1. A medical device that is used by being inserted into a body cavity and has a long tubular body having flexibility,
The tubular body is
A first tubular body made of a wire material;
A melted portion in which end portions of the wire material of the first tubular body are integrally melted;
A medical device comprising: a second tubular body made of a wire material, and an end portion of the wire material connected to the melting portion of the first tubular body.
2. The first tubular body is formed in a coil shape by winding one or a plurality of the wire materials in one or multiple lines,
When the end portions of the wire material of the first tubular body are melted, the adjacent wire materials are joined to each other to form an end surface in the melted portion, and the end surface of the second tubular body is formed on the end surface. 1. The ends of the wire material are connected. Medical device as described in.
3. The second tubular body is formed in a coil shape by winding one or a plurality of the wire materials in a single or multiple line,
When the end portions of the wire material of the second tubular body are melted, the adjacent wire materials are joined to each other to form a melted portion in the second tubular body, and to the melted portion. An end face is formed,
1. The end surface of the first tubular body and the end surface of the second tubular body are connected to each other. Medical device as described in.
4). The first tubular body is formed in a coil shape by winding one or a plurality of the wire materials in one or multiple lines,
The second tubular body is formed by braiding a plurality of the wire materials into a mesh shape,
1. The end of the wire-like wire material of the second tubular body is connected to the end surface of the first tubular body. Medical device as described in.
5. 1. The end surfaces joined and formed by melting the end portions of the wire material are flattened by cutting and polishing the melted portions. To 4. The medical device according to any one of the above.
6). The first tubular body and the second tubular body are different from each other in the shape of the end of the wire material or the diameter of the wire material,
2. The end portions of the wire materials are melted to form the end surfaces of the melted portions, and the end surfaces are connected to each other. To 5. The medical device according to any one of the above.
7). 5. The inner diameter of the melting portion of the first tubular body is equal to the inner diameter of the end portion of the second tubular body. Medical device as described in.
8). 6. The inner peripheral surface of the melting portion of the first tubular body and the inner peripheral surface of the end portion of the second tubular body are continuous. Medical device as described in.
9. The diameter of the first tubular body increases toward the end connected to at least one of the inner peripheral surface of the melting portion or the inner peripheral surface of the end of the second tubular body. The taper cut portion is formed so that the bending rigidity between the first tubular body and the second tubular body with the end portion as a boundary is continuous. To 8. The medical device according to any one of the above.
10. The melting part is an annular melting part that forms an annular shape around the first tubular body;
1. The axial direction of the annular melted portion and the axial direction of the first tubular body intersect each other at an intersecting angle of less than 90 degrees. To 9. The medical device according to any one of the above.
11. 9. The intersection angle is 45 degrees or less. Medical device as described in.
12 9. A blunt head having a smaller radius of curvature than the wire material of the first tubular body is formed at a sharp end of the annular melted portion. Or 11. Medical equipment described in 1.
13. The melting part is an annular melting part that forms an annular shape around the first tubular body;
1. The axial center direction of the annular molten portion and the axial direction of the first tubular body are parallel to each other. To 9. A medical device according to any one of the above.
14 1. The end face formed by melting the end portion of the wire material is thinned in the outer diameter direction by polishing the outer periphery. To 13. The medical device according to any one of the above.
15. The first tubular body and the second tubular body are formed by braiding a plurality of the wire materials into a mesh shape,
1. Intersections of the ends of the wire material of the braid of the first tubular body and the second tubular body are connected to each other. Medical device as described in.
16. The first tubular body and the second tubular body are connected by welding. To 15. The medical device according to any one of the above.
17. The first tubular body and the second tubular body are different in the number of strips of the wire material. To 16. The medical device according to any one of the above.
18. 1. The outer periphery of the connection part of said 1st tubular body and said 2nd tubular body was further brazed. To 17. The medical device according to any one of the above.
19. The wire material of the first tubular body and the wire material of the second tubular body are made of the same metal. To 18. The medical device according to any one of the above.
20. The other end of the first tubular body opposite to the connection portion with the second tubular body, or the other end of the second tubular body opposite to the connection portion with the first tubular body. A third tubular body is connected to the end or between the first tubular body and the second tubular body. To 19. The medical device according to any one of the above.
21. The main lumen,
An inner layer having the main lumen inside;
On the outer peripheral surface of the inner layer, a reinforcing layer made of the tubular body,
A catheter having at least an outer layer covering the inner layer including the reinforcing layer. To 20. The medical device according to any one of the above.
22. A melting step of forming a melted portion including melting an end of the wire material of the first tubular body made of the wire material;
An abutting step of abutting the melted part of the first tubular body and the end of the wire material of the second tubular body made of a wire material;
A connecting step of obtaining a tubular body extending in the longitudinal direction by connecting a contact portion between the melted portion of the first tubular body and the end portion of the wire material of the second tubular body; A method for manufacturing a medical device.
23. The melting step includes
A cutting step of cutting the melted portion at a predetermined position;
A planarization step of polishing the cut melted part to form a flat end surface; A method for producing a medical device according to claim 1.
24. The melting step or the connecting step includes
Polishing the outer periphery of the melted part after the melting step or the outer periphery of the connecting part after the connecting step, and reducing the thickness in the outer diameter direction of the first tubular body or the tubular body, Further include 22. Or 23. A method for producing a medical device according to claim 1.
25. In the connecting step, the melted portion of the first tubular body and the end portion of the second tubular body that are in contact with each other in the contact step are belt-shaped with a laser in the circumferential direction. 21. includes a laser welding process that melts and connects the abutting portions; To 24. The manufacturing method of the medical device as described in any one of these.
26. In the connecting step, the entire outer periphery of the abutting portion of the end portion of the first tubular body abutted in the abutting step and the end portion of the second tubular body is strip-shaped by resistance welding or heating. A heat-welding step of joining the abutting portions by melting to a temperature of 22. To 24. The manufacturing method of the medical device as described in any one of these.
27. 21. The method further includes a brazing step of brazing the outer periphery of the coupling portion of the first tubular body and the second tubular body coupled in the coupling step. To 26. The manufacturing method of the medical device as described in any one of these.

10, 110, 210, 310, 510, 610 First tubular body 11a, 21a, 21b, 111, 211, 311, 321, 361, 511, 521, 611, 612 Wire material 12, 22, 212, 222, 512 522 Melting part 30, 130, 230, 330, 530, 530a, 530b, 630 Connecting part 12a, 22a, 112, 212a, 222a, 512a, 522a, 614, 624 End face 20, 220, 320, 520, 620 Second Tubular body 360 Third tubular body 240, 540 Wax material 100, 200, 300, 500, 600 Tubular body (reinforcing layer)
400 catheter (medical equipment)
476 Inner layer 613, 623, 633 Annular melted part 615 Irradiation mark 616, 626 Taper cut part 617, 627 Blunt head

Claims (26)

A medical device that is used by being inserted into a body cavity and has a long tubular body having flexibility,
The tubular body is
A first tubular body made of a wire material;
A melted portion provided at an end of the wire material of the first tubular body;
Have a, a second tubular body that Do from line materials,
An end of the wire material of the second tubular body is connected to the melted portion of the first tubular body;
A taper-cut portion that expands toward the end connected to at least one of the inner peripheral surface of the melting portion of the first tubular body or the inner peripheral surface of the end portion of the second tubular body. Is formed so that the bending stiffness between the first tubular body and the second tubular body with the end portion as a boundary is continuous . The shape of the first tubular body is a coil shape in which one or a plurality of the wire materials are wound in a single line or multiple lines,
The melting portion has an end surface formed by joining the adjacent wire materials by melting the end portions of the wire material of the first tubular body ,
The said end face, said end portion of said wire material of the second tubular body is connected, medical device according to claim 1. The shape of the second tubular body is a coil shape in which one or a plurality of the wire materials are wound in a single line or multiple lines,
In the second tubular body, the end portion of the wire material of the second tubular body is melted and the adjacent wire materials are joined to each other, and the melted portion Having an end face formed,
The medical device according to claim 2, wherein the end surface of the first tubular body and the end surface of the second tubular body are connected to each other. The shape of the first tubular body is a coil shape in which one or a plurality of the wire materials are wound in a single line or multiple lines,
The second tubular body is formed by braiding a plurality of the wire materials into a mesh shape,
The medical device according to claim 2 or 3 , wherein the end portion of the mesh-like wire material of the second tubular body is connected to the end surface of the first tubular body. Wherein said end face of said end surface and the second tubular body of the first tubular body, the medical device according to claim 3 which is flattening. The first tubular body and the second tubular body are different from each other in the shape of the end of the wire material or the diameter of the wire material,
The medical device according to claim 3 or 5 , wherein the end surface of the first tubular body and the end surface of the second tubular body are connected to each other. Medical equipment according to claim 6 and the inner diameter of said end portion is equal to said second tubular body and the inner diameter of the molten portion of the first tubular member. Medical equipment according to claim 7 in which the inner peripheral surface of the end portion of the inner peripheral surface and the second tubular body of the molten portion of the first tubular body is continuous. The melting part is an annular melting part that forms an annular shape around the first tubular body;
Medical equipment according to any one of claims 1 to 8, the axial direction of the axial direction and the first tubular body of the annular molten portion intersect each other at an intersection angle of less than 90 degrees. Medical equipment according to claim 9 wherein the crossing angle is 45 degrees or less. Wherein the sharp end of the annular molten portion, medical equipment according to claim 9 or 10 is formed with a small radius of curvature of blunt head than the line material of the first tubular member. The melting part is an annular melting part that forms an annular shape around the first tubular body;
Medical equipment according to any one of claims 1 to 8 in the axial direction in the axial direction with the first tubular body of the annular molten portion are parallel to each other. The medical device according to any one of claims 3 to 6 , wherein a thickness of the end surface of the first tubular body and a thickness of the end surface of the second tubular body in the outer diameter direction are reduced. The first tubular body and the second tubular body are formed by braiding a plurality of the wire materials into a mesh shape,
The medical device according to claim 1, wherein intersections of the end portions of the wire material of the braid of the first tubular body and the second tubular body are connected to each other. The medical device according to any one of claims 1 to 14 , wherein the first tubular body and the second tubular body are connected by welding. The medical device according to any one of claims 1 to 15 , wherein the first tubular body and the second tubular body have different numbers of strips of the wire material. The medical device according to any one of claims 1 to 16 , wherein an outer periphery of a connection portion between the first tubular body and the second tubular body is further brazed. The medical device according to any one of claims 1 to 17 , wherein the wire material of the first tubular body and the wire material of the second tubular body are made of the same kind of metal. The other end of the first tubular body opposite to the connection portion with the second tubular body, or the other end of the second tubular body opposite to the connection portion with the first tubular body. The medical device according to any one of claims 1 to 18, wherein a third tubular body is further connected to the end . The main lumen,
An inner layer having the main lumen inside;
On the outer peripheral surface of the inner layer, a reinforcing layer made of the tubular body,
The medical device according to any one of claims 1 to 19 , which is a catheter having an outer layer covering at least the inner layer including the reinforcing layer. A melting step of forming a melted portion including melting an end of the wire material of the first tubular body made of the wire material;
An abutting step of abutting the melted part of the first tubular body and the end of the wire material of the second tubular body made of a wire material;
A connecting step of obtaining a tubular body extending in the longitudinal direction by connecting a contact portion between the melted portion of the first tubular body and the end portion of the wire material of the second tubular body; only including,
In the connecting step, at least one of the inner peripheral surface of the melting portion of the first tubular body and the inner peripheral surface of the end portion of the second tubular body expands toward the end portion connected to each other. A method of manufacturing a medical device , wherein a tapered cut portion that is formed in a diameter is formed, and the first tubular body and the second tubular body having the end as a boundary are connected so that bending rigidity is continuous . The melting step includes
A cutting step of cutting the melted portion at a predetermined position;
The method for manufacturing a medical device according to claim 21 , further comprising a flattening step of polishing the cut molten part to form a flat end surface. The melting step or the connecting step includes
Polishing the outer periphery of the melted part after the melting step or the outer periphery of the connecting part after the connecting step, and reducing the thickness in the outer diameter direction of the first tubular body or the tubular body, Furthermore, the manufacturing method of the medical device of Claim 21 or 22 further included. In the connecting step, the melted portion of the first tubular body and the end portion of the second tubular body that are in contact with each other in the contact step are belt-shaped with a laser in the circumferential direction. The method for manufacturing a medical device according to any one of claims 21 to 23 , further comprising a laser welding step of melting and connecting the contact portions. In the connecting step, the entire outer periphery of the abutting portion of the end portion of the first tubular body abutted in the abutting step and the end portion of the second tubular body is strip-shaped by resistance welding or heating. and melted to connect the abutting portion, the production method of the medical device according to any one of claims 21 to 23 comprising heating the welding process. The medical treatment according to any one of claims 21 to 25 , further comprising a brazing step of brazing the outer periphery of the coupling portion of the first tubular body and the second tubular body coupled in the coupling step. Device manufacturing method.

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