JP2012100829A - Catheter and method of manufacturing the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To easily perform an operation for pulling out a broken wire material, during catheter manufacturing operations.SOLUTION: A catheter 100 is formed by having a tubular body 10 including: an inner layer 11 that is formed of a resin material 111 and that has a main lumen 20 inside; a coil layer 30 that is formed by having the wire material 31 wound around a spiral groove 112 formed on the outer peripheral surface of the inner layer 11; an outer layer 12 for covering the coil layer 30; a recessed groove 113 that is formed near the distal end 15 of the inner layer 11 in such a manner as to continue into the spiral groove 112 and formed in such a shape that a spiral pitch becomes gradually larger in the direction of the distal end 15; and a marker 40 that is mounted on the outer periphery of the recessed groove 113.

Description

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

  In recent years, there has been provided a catheter capable of manipulating the direction of entry into a body cavity by bending a distal end portion (see, for example, Patent Document 1). In this Patent Document 1, it is described that a coiled marker formed of a radiopaque material is provided on the catheter in order to operate while confirming the position of the catheter in the body cavity. In Patent Document 1, as a coil layer for reinforcing the catheter, a knitted body in which metal strands are knitted in a mesh shape is disposed up to the vicinity of the distal end portion, and a metal end is provided closer to the proximal end portion side than the marker. The coil body is arranged. Since the coil layer and the marker of patent document 1 are only arrange | positioned on the outer peripheral surface of an inner layer, they are easy to drop off. Therefore, it is considered that the coil layer can be prevented from falling off if the coil layer is bitten into the inner layer. If the marker is adhered to the outer periphery of the groove-like trace obtained by removing a part of the coil layer, the marker anchor effect can be obtained and the marker can be prevented from falling off.

JP 2010-88833 A

  However, in this case, even if the coil layer and the marker can be prevented from falling off, the coil bites into the inner layer, so that there is a problem that the coil is difficult to remove and the productivity is poor.

  The present invention has been made in view of the above problems, and an object of the present invention is to provide a catheter capable of easily removing a coil and having excellent manufacturability and a method for manufacturing the catheter.

  The catheter of the present invention is a catheter including a long tubular body having a main lumen inside and formed of a resin material, and the tubular body is formed on an inner layer having a main lumen inside and an outer peripheral surface of the inner layer. A coil layer formed by winding a wire material around the spiral groove, an outer layer covering the coil layer, and a spiral groove formed in the vicinity of the distal end of the inner layer in the direction toward the distal end. And a concave groove having a gradually increased spiral pitch.

  The catheter of the present invention has a spiral groove on the outer peripheral surface of the inner layer, and has a concave groove with a series of spiral grooves formed in such a manner that the spiral pitch gradually increases in the direction of the distal end. Therefore, it is possible to simultaneously form the spiral groove and the concave groove having a gradually increased spiral pitch while causing the wire material to penetrate into the inner layer. A coil layer can also be formed at the same time. And a ditch | groove can be formed by rupturing a wire material between coil layers, and pulling out while rotating a wire material from a ditch | groove. At that time, since the spiral pitch of the groove is gradually increased, the number of rotations can be reduced. Furthermore, since the helical pitch is wide, the springback force of the wire material deformed into a coil shape becomes remarkable, and the drawing work of the wire material from the concave groove can be performed more easily with a small number of rotations. Therefore, a catheter excellent in manufacturability and a method for manufacturing the catheter can be provided.

  In the catheter of the present invention, a marker may be mounted on the outer periphery of the groove.

  In the catheter of the present invention, the coil layer may be formed by winding a wire material so as to bite to a depth that is approximately half the thickness of the inner layer.

  In the catheter of the present invention, the coil layer may be formed by winding the wire material with a winding pitch widened toward the vicinity of the distal end.

  In the catheter of the present invention, the coil layer gradually reduces the depth of penetration of the wire material into the inner layer when the wire material is wound with the winding pitch widened toward the vicinity of the distal end. May be.

  Further, in the catheter of the present invention, the concave groove is on the distal end side where the winding pitch is the widest among the coil layers formed by winding the wire material by expanding the winding pitch to the distal end portion of the inner layer. It may be formed by removing at least one turn.

  In the catheter of the present invention, a marker may be mounted on the outer periphery of the concave groove, and the marker may be disposed apart from the coil layer.

  In the catheter of the present invention, a marker may be mounted on the outer periphery of the concave groove, and the marker may be formed in the same layer as the coil layer.

  The catheter manufacturing method of the present invention is a method for manufacturing a catheter including a long tubular body having a main lumen inside and formed of a resin material, the step of forming an inner layer on the outer periphery of the core wire, Forming a coil layer on a spiral groove formed by winding a wire material around the outer peripheral surface of the inner layer, and forming a spiral groove near the distal end of the inner layer, and gradually toward the distal end. A step of forming a tubular body by a step of forming a groove having a wide spiral pitch and a step of forming an outer layer on the outer peripheral surface of the inner layer including the groove and the coil layer.

  In the catheter manufacturing method of the present invention, the coil layer is formed by winding a wire material on a spiral groove formed on the outer peripheral surface of the inner layer. Further, a spiral groove is formed in the vicinity of the distal end portion of the inner layer, and a concave groove having a spiral pitch gradually increased in the direction of the distal end portion. Therefore, for example, when winding a wire material gradually with a wide winding pitch, and breaking the widely wound portion and pulling out the wire material to form a concave groove, the spiral pitch of the concave groove is wide, so the rotation is small The operation | work which pulls out the wire material fractured | ruptured by number can be performed easily. Therefore, the manufacturability of the catheter can be improved.

  Moreover, in the manufacturing method of the catheter of this invention, you may further have the process of mounting | wearing a marker on the outer periphery of a ditch | groove.

  Further, in the catheter manufacturing method of the present invention, the coil layer is formed by winding a wire material so as to bite into the inner layer to the distal end of the outer periphery of the inner layer, and the concave groove is formed near the distal end. The wire material may be formed by removing at least one turn.

  Moreover, in the manufacturing method of the catheter of this invention, a wire material may be wound so that it may bite in to the half of the depth of an inner layer.

  Moreover, in the manufacturing method of the catheter of this invention, a coil layer may wind a wire material so that the winding pitch of a wire material becomes large gradually, so that it is near a distal end part.

  Further, in the method for producing a catheter of the present invention, the wire material gradually reduces the biting depth of the wire material into the inner layer when the wire material is wound with the winding pitch gradually widened toward the vicinity of the distal end. There may be.

  In the method for producing a catheter of the present invention, a step of mounting a marker on the outer periphery of the groove, and a step of applying the same resin material as the resin material forming the outer layer between the groove and the marker May further be included.

  Further, in the catheter manufacturing method of the present invention, it has a step of mounting a marker on the outer periphery of the groove and a step of forming an outer layer, and when forming the outer layer, between the groove and the marker, The resin material forming the outer layer may be filled.

  According to the present invention, the wire material is wound around the outer peripheral surface of the inner layer, and a part of the wire material is broken and removed to form the groove. Moreover, since the winding pitch of the wire material in the formation part of the ditch | groove is made wide, removal of the broken wire material can be performed easily. Furthermore, the breaking position of the wire material can be clarified by changing the winding pitch. Therefore, it is possible to provide a catheter with improved working efficiency and excellent manufacturability.

It is a sectional side view of the front-end | tip part of the catheter which concerns on 1st Embodiment. It is the XX sectional view taken on the line of FIG. It is the YY sectional view taken on the line of FIG. It is a partially expanded sectional view of the marker and coil layer vicinity of the catheter which concerns on 1st Embodiment. It is a figure which shows roughly a part of process of the manufacturing method of the coil layer and marker which concerns on 1st Embodiment, Comprising: (a) is a proximity edge between the windings of adjacent wire material on the outer side of an inner layer It is a schematic diagram which shows the state which wound the wire material by changing the distance, (b) is a schematic diagram which shows the state in which the ditch | groove was formed by cutting and removing the wire material of the marker mounting plan part. And (c) is a schematic view showing a state in which a marker is attached to the groove portion from which the wire material has been removed. It is a side view which shows the whole catheter which concerns on 1st Embodiment, and a side view which shows the bending example of a front-end | tip part, Comprising: (a) is a side view which shows the whole before a catheter is bent, (b) Is a side view showing a state where the tip is bent upward, and (c) is a side view showing a state where the tip is bent downward. It is a sectional side view of the front-end | tip part in the catheter of the modification 1 of 1st Embodiment. It is a sectional side view of the front-end | tip part in the catheter of the modification 2 of 1st Embodiment. It is a sectional side view of the front-end | tip part of the catheter which concerns on 2nd Embodiment. It is a side view which shows the whole catheter concerning 2nd Embodiment, and a side view which shows the bending example of a front-end | tip part, Comprising: (a) is a side view which shows the whole before a catheter is bent, (b) FIG. 4 is a side view showing a state in which the tip is bent upward by operating the slider, and (c) is a side view showing a state in which the tip is bent upward with a larger curvature than in (b) by operating the slider. (D) is a side view showing a state where the slider is operated to bend the tip downward, and (e) is a slider operated to bend the tip downward with a larger curvature than (d). It is a side view which shows the state made to do.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same components are denoted by the same reference numerals, and description thereof will be omitted as appropriate.

[First Embodiment]
FIG. 1 is a side sectional view of the distal end portion of the tubular main body 10 in the catheter 100 according to the first embodiment. The left side of FIG. 1 corresponds to the distal end side (hereinafter also referred to as “distal end side DE”) of the catheter 100, and the right side is also referred to as the proximal side (hereinafter referred to as “proximal end side” or “proximal end side CE”). ) However, the proximal end CE of the catheter is not shown in FIG. 2 is a cross-sectional view taken along the line XX of FIG. 1 and is a cross-sectional view of the catheter 100 cut in the vicinity of the coil layer (coil) 30. 3 is a cross-sectional view taken along the line YY of FIG. 1, and is a cross-sectional view of the catheter 100 cut near the marker 40. FIG. 4 is a partially enlarged cross-sectional view of the vicinity of the marker 40 and the coil layer 30 of the catheter 100 according to the first embodiment, and shows the positional relationship between the marker 40 and the coil layer 30. Further, the resin material 121 of the outer layer 12 enters between the marker 40 and the inner layer 11. FIG. 5 is a schematic diagram showing an example of a process for manufacturing the catheter 100 according to the first embodiment. In order to make these processes easy to understand, the drawing is made with dimensions different from the actual dimensions. FIG. 5A is a diagram in which the coil layer 30 is formed by changing the winding pitch between the windings of the wire material 31. FIG. 5B shows a state in which the groove material 113 is formed by cutting and removing the wire material 31 at the portion where the marker 40 is to be attached. FIG. 5C is a side view showing a state in which the marker 40 is mounted at the position of the concave groove 113 from which the wire material 31 has been removed and at a distance B from the coil layer 30. FIG. 6A shows an overall side view of the catheter 100 according to the first embodiment, and FIGS. 6B and 6C are side views showing a bent example of the distal end portion of the catheter 100. FIG. 7 is a cross-sectional view of the distal end of the catheter 101 of the first modification in which the winding pitch of the coil layer 30 is gradually increased. FIG. 8 is a cross-sectional view of the distal end of the catheter 102 of Modification 2 in which a spiral protrusion 141 corresponding to the concave groove 113, that is, a so-called screwed portion, is provided on the inner peripheral surface of the marker 140.

  The catheter 100 according to the present embodiment includes a long tubular body 10 having a main lumen 20 therein, as shown in FIGS. Specifically, the tubular body 10 is formed by winding a wire material 31 on an inner layer 11 formed of a resin material 111 and having a main lumen 20 inside, and a spiral groove 112 formed on the outer peripheral surface of the inner layer 11. The formed coil layer 30, the outer layer 12 covering the coil layer 30, the groove 113 formed near the distal end of the inner layer 11, and having a gradually increased helical pitch in the direction of the distal end, And a marker 40 mounted on the outer periphery of the concave groove 113.

  Hereinafter, the structure of the catheter 100 of this embodiment is demonstrated concretely. As shown in FIG. 1, the tubular body 10 of the catheter 100 according to the present embodiment includes an inner layer 11 formed of a resin material 111, and an outer layer 12 formed of a resin material 121 of the same or different type from the inner layer 11. have. The tubular body 10 that is the body of the catheter 100 including the inner layer 11 and the outer layer 12 is called a sheath. Further, the inner layer 11 or the outer layer 12 may be formed as a single layer, or may be the inner layer 11 or the outer layer 12 having a multilayer structure formed of two or more kinds of different or similar materials. In the present embodiment, the coil layer 30 disposed on the outer periphery of the inner layer 11 is formed by, for example, winding a single wire material 31 formed of an elastic body in a spiral shape. In the present embodiment, the wire material 31 is wound around the outer peripheral surface of the inner layer 11, and the spiral groove 112 and the coil layer 30 are formed at the same time. In addition, the spiral groove 112 and the concave groove 113 are formed by winding the wire material 31 to the distal end side DE, and then forming the spiral groove 112 by removing the wire material 31 only at the concave groove 113 portion later. 112 and the concave groove 113 are continuous in series. The marker 40 is mounted on the outer periphery of the concave groove 113 with the coil layer 30 and the separation distance B therebetween. Moreover, the inner layer 11 and the outer layer 12 may be comprised by the single layer, and may be comprised by the multilayer.

  In addition, the concave groove 113 of the present embodiment will be described in detail in a manufacturing method described later. In the vicinity of the distal end portion 15 of the wire material 31, the distances C1 to C3 between adjacent edges of the adjacent wire material 31 are represented by coils. The layer 30 is wound so as to gradually become larger than the distance A between adjacent edges. And it is obtained by removing the wire material 31 of this distance between adjacent edges C1 to C3. Therefore, the distance between adjacent edges when winding the wire material 31 is A <C1 <C2 <C3. Further, as shown in FIG. 1 or FIG. 4, since the wire material 31 is wound so as to bite into the thickness a of the inner layer 11 to the bite depth b, the depth of the spiral groove 112 and the concave groove 113 is also b. Become. The biting depth b allows the wire material 31 to bite into the inner layer 11 to form the spiral groove 112 and the concave groove 113, maintain the flatness of the inner cavity of the inner layer 11, and prevent the wire material 31 from falling off. As long as it is possible, there is no particular limitation. For example, the biting depth b may be 1/3 to 2/3 of the thickness a of the inner layer 11. Further, the biting depth b is preferably about ½ of the thickness a, and the adhesion between the coil layer 30 or the marker 40 and the inner layer 11 is further improved. Further, the wire material 31 may be included in the inner layer 11 as long as the flatness is not lowered. In the present embodiment, the spiral groove 112, the concave groove 113, and the coil layer 30 are formed simultaneously while winding the wire material 31. However, the present application is not limited to this, and the spiral groove 112 and the concave groove 113 may be separately formed on the outer surface of the inner layer 11, and the coil layer 30 may be formed in the spiral groove 112 later. Alternatively, the spiral groove 112 and the concave groove 113 may be formed without being continuously connected.

  Moreover, in the catheter 100 of this embodiment, since the spiral groove 112 and the concave groove 113 are continuously formed in series, the concave groove 113 is formed in the same layer as the coil layer 30. Note that the concave groove 113 and the coil layer 30 are formed in the same layer when the positions of the concave groove 113 and the coil layer 30 coincide when observed in the radial direction of the tubular body 10. Say. More specifically, as in the present embodiment, the centers of the thickness e of the concave groove 113 and the amount of biting b into the inner layer 11 of the coil layer 30 coincide with each other, or the depth of the concave groove 113. This means that e and the biting depth b are the same or substantially the same. Alternatively, even if there is a gap between the surface of the biting portion of the coil layer 30 and the concave groove 113, at least a part of the biting depth b of the coil layer 30 is preferably within the depth e of the concave groove 113. It means that there is.

  The marker 40 is made of a radiopaque material. Therefore, by confirming the position of the marker 40 with X-rays, it can be understood to which position in the patient's body the catheter 100 has been inserted. In the present embodiment, the marker 40 is attached to the outer periphery of the inner layer 11 via the coil layer 30 and the separation distance B. The marker 40 and the coil layer 30 are formed in the same layer as shown in FIG. The marker 40 and the coil layer 30 being formed in the same layer means that the positions of the marker 40 and the coil layer 30 coincide with each other when observed in the radial direction of the tubular body 10. . More specifically, it means that the centers of the marker 40 and the coil layer 30 are coincident with each other. Alternatively, the center of the radial thickness of the marker 40 is within the radial thickness of the coil layer 30 and the center of the radial thickness of the coil layer 30 is within the radial thickness of the marker 40. .

  Thus, since the relationship between the marker 40, the coil layer 30, and the concave groove 113 is configured as described above, the coil layer 30 and the marker 40 are not stacked, and the coil layer 30 is not laminated. Bites into the inner layer 11. Therefore, the tubular main body 10 does not become thick. As will be described later, even when the marker 40 is crimped to the outer periphery of the inner layer 11, the coil layer 30 is not affected, and therefore the inner layer 11 is not deformed to the lumen side together with the coil layer 30. Therefore, the flatness of the main lumen 20 can be maintained. Further, the caulking of the marker 40 and the filling of the resin material 121 into the marker 40 and the recessed groove 113 as described later increase the adhesion between the recessed groove 113 and the marker 40. As a result, the anchor effect is improved, and the positional displacement suppression effect in the axial direction of the marker 40 at the time of manufacturing or using the catheter 100 can be improved.

  The relationship between the distance B between the marker 40 and the coil layer 30 and the distance between adjacent edges A and C1 to C3 is formed so that A <C1 <C2 <C3 <B in this embodiment. Yes. However, if the marker 40 and the coil layer 30 can be clearly detected when the marker 40 is detected by X-rays, the present application is not limited to this, and an arbitrary distance can be set. For example, the coil layer 30 and the marker 40 can be more clearly distinguished by making the separation distance B at least wider than the outer diameter D of the wire material 31. Further, as in the present embodiment, it is more preferable that the separation distance B is larger than the distance A between adjacent edges, and the distinction between the coil layer 30 and the marker 40 position is further clarified. More preferably, the separation distance B may be equal to or greater than the sum of the adjacent edge distance A and the outer diameter D, and the coil layer 30 and the marker 40 can be more clearly distinguished. However, if the separation distance B is too large, the rigidity of the separation distance B portion of the tubular body 10 may decrease. However, in such a case, by taking measures such as disposing an X-ray transmissive reinforcing member in the separation distance B portion, the rigidity is not lowered, and the coil layer 30 and the marker 40 are not easily distinguished from each other. Never become.

  Further, around the outer layer 12 on the distal end side DE of the tubular body 10, a hydrophilic coat layer 50 whose outer surface is lubricated is optionally provided as the outermost layer of the tubular body 10.

  The tubular body 10 having such a configuration and the syringe connector 60 constitute the catheter 100 according to the first embodiment. In this catheter 100, following the shape of the guide wire, the distal end portion of the tubular body 10 is changed from the linear shape of FIG. 6 (a) to the distal end portion of the tubular body 10 as shown in FIGS. 6 (b) and 6 (c). The 15 side can be bent freely in the vertical direction.

  Here, the distal end 15 of the catheter 100 refers to a range of a predetermined length including the distal end DE (tip) of the catheter 100. The distal end DE is also the distal end of the tubular body 10. Further, the proximal end portion 16 of the catheter 100 refers to a range of a predetermined length including the proximal end CE of the catheter 100 (see FIG. 6). Similarly, the distal end portion of the tubular body 10 refers to a range of a predetermined length including the distal end side DE, and the proximal end portion of the tubular body 10 refers to the proximal end side PE of the tubular body 10. A range of a predetermined length including

  Here, the bending of the catheter 100 means that the catheter 100 is deformed (bent) so that the central axis of the catheter 100 (for example, the central axis of the main lumen 20) is not a straight line (such as a curved line or a polygonal line). To do.

  As a material for the inner layer 11, for example, a fluorine-based thermoplastic polymer can be used. More specifically, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), perfluoroalkoxy fluororesin (PFA), or the like can be used. As described above, by using the fluorine-based resin for the inner layer 11, the delivery property when supplying a contrast medium or a drug solution to the affected area through the main lumen 20 of the catheter 100 is improved.

  As the material of the outer layer 12, for example, a thermoplastic polymer can be used. Examples include polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA), poly Vinyl chloride (PVC) or polypropylene (PP) can be used.

  As a material of the coat layer 50, for example, a hydrophilic resin material 51 such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone can be used.

  As a material of the marker 40, for example, an X-ray opaque material such as platinum can be used. In this embodiment, the marker 40 is formed of a ring. However, the marker 40 is not limited to the ring, and may be formed of a coiled wire material 31 as long as it is separated from the coil layer 30 in the longitudinal direction. Alternatively, a metal plate or the like may be used.

  The wire material 31 constituting the coil layer 30 is preferably a metal wire material. However, the present application is not limited to this, and is made of a material that has higher rigidity and elasticity than the inner layer 11 and the outer layer 12 and can cut into the inner layer 11 to form the spiral groove 112 and the concave groove 113. Any other material (for example, resin) may be used. Further, specifically, for example, stainless steel (SUS), nickel titanium alloy, steel, titanium, or copper alloy can be used as the metal material of the wire. The cross-sectional shape of the wire material 31 is not particularly limited, and may be any shape such as a circle, an ellipse, a square, a rectangle, and a polygon. In the present embodiment, as shown in FIG. As described above, the material for forming the catheter 100 can be appropriately selected in consideration of cost, ease of manufacture, purpose of use, and the like.

  Further, in the present embodiment, as described above, the winding pitch of the wire material 31, that is, the distance between adjacent edges between the windings of the adjacent wire material 31 is the densely wound portion 32 and the narrow interval portion 33 (distance between adjacent edges). A), the wide interval portion 34 (distance between adjacent edges C1 to C3) is gradually increased. Thus, the flexibility of the distal end side DE is improved by changing the winding pitch. Furthermore, the presence of the wide spacing portion 34 has an advantage that the cutting site of the wire material 31 for securing the mounting portion of the marker 40 at the time of manufacturing the catheter 100 is easy to understand.

  By forming the coil layer 30 with such a wire material 31, the catheter 100 becomes firmer and can maintain its form stability. In the present embodiment and the following embodiments, the coil layer 30 is formed of a single wire material 31, but the present application is not limited to this. For example, a plurality of wire materials 31 are formed as inner layers. The coil layer 30 may be formed of a multi-strand coil wound around the outer peripheral surface of the coil 11.

  Here, typical dimensions of the catheter 100 of the present embodiment will be described. First, the radius of the main lumen 20 can be about 200 to 300 μm. The thickness of the inner layer 11 can be about 10 to 30 μm, the thickness of the outer layer 12 can be about 100 to 220 μm, the outer diameter of the coil layer 30 can be 500 to 860 μm, and the inner diameter of the coil layer 30 can be 420 to 660 μm. And the outermost radius including the coat layer 50 from the axial center (of the tubular main body 10) of the catheter 100 can be about 350-490 micrometers.

  That is, the outer diameter of the catheter 100 of this embodiment is less than 1 mm in diameter, and can be inserted into blood vessels such as the celiac artery. In addition, the catheter 100 of the present embodiment can enter the catheter 100 in a desired direction even in a branching blood vessel, for example.

  Next, an example of a method for manufacturing the catheter 100 of the present embodiment having the above-described configuration will be described. The catheter 100 manufacturing method of the present embodiment includes a step of forming the inner layer 11 with the resin material 111 on the outer periphery of the core wire (hereinafter referred to as “inner layer forming step”), and a resin material of the inner layer 11 on the outer peripheral surface of the inner layer 11. A step of forming the coil layer 30 with a wire material 31 that is harder than the material 111 (hereinafter referred to as a “coil layer forming step”), and an irregularity on the outer periphery of the inner layer 11 and in the vicinity of the distal end portion 15. A step of forming the concave groove 113 which is a portion (hereinafter referred to as “concave groove forming step”), a step of mounting the marker 40 on the outer periphery of the concave groove 113 (hereinafter referred to as “marker mounting step”), Forming the outer layer 12 with the resin material 121 on the outer periphery of the inner layer 11 including at least the marker 40 and the coil layer 30 to form the tubular body 10 (hereinafter referred to as “outer layer forming step”). The present embodiment further includes a step of forming the coat layer 50 around the outer layer 12 (hereinafter referred to as “coat layer forming step”). In the catheter 100 manufactured by the manufacturing method including such steps, the marker 40 is mounted on the outer periphery of the concave groove 113 formed in the vicinity of the distal end portion 15 of the inner layer 11. Increases the anchor effect. Therefore, it is possible to prevent the positional deviation of the marker in the axial direction during the work process or during use, and to obtain a highly accurate product efficiently. Therefore, the catheter 100 excellent in usability can be provided at a low price.

  In the present embodiment, in the coil layer forming step, the spiral groove 112 and the coil layer 30 are wound by winding the wire material 31 so as to bite into the inner layer 11 up to the distal end 15 on the outer periphery of the inner layer 11. And at the same time. Further, in the concave groove forming step, the spiral groove 112 is removed by removing at least one turn of the portion of the wire material 31 wound in the coil shape in the coil layer forming step to be mounted with the marker 40 at the distal end portion 15. A series of spiral grooves 113 are formed. Note that the coil layer forming step and the concave groove forming step are examples, and the present invention is not limited to these, and any other method may be used.

  Moreover, as a method of cutting the wire material 31 in the concave groove forming step, it is preferable that the wire material 31 is broken by laser irradiation. However, the present application is not limited to this, and the cutting method of the wire material 31 may be a cutting method using a burner or a cutter, may be threaded, or any other cutting method may be used. May be.

  Further, in the inner layer forming step, it is preferable to form the inner layer 11 by extruding the resin material 111 on the core wire or forming a dispersion coating. In the outer layer forming step, the outer layer 12 may be formed by extruding the resin material 121. However, in this embodiment, a tubular outer layer 12 having an inner diameter wider than the outer diameter of the inner layer 11 is formed in advance, and this outer layer 12 is attached to the outer periphery of the inner layer 11. Further, a heat shrinkable tube (not shown) is attached to the outer periphery and heated, and the heat shrinkable tube is heat shrunk to bring the inner layer 11 and the outer layer 12 into close contact. Thereafter, the heat shrink tube is removed. By using such a method, the outer layer 12 can be easily formed. Further, the resin material 121 of the outer layer 12 melts and penetrates between the concave groove 113 and the marker 40 during heat shrinkage of the heat shrinkable tube and solidifies, thereby improving the adhesion between the two (hereinafter referred to as “resin”). This is called “material filling process”). Alternatively, before the marker mounting step, a step of applying the same resin material 121 as the outer layer 12 to the outer periphery of the concave groove 113 (hereinafter referred to as “resin material application step”), that is, the resin material 121 is pre-scaled. May be. Then, even if a marker mounting process is performed and then the outer layer 12 forming process is performed in the outer layer forming process, the adhesion between the marker 40 and the inner layer 11 can be improved by the resin material 121. The inner layer forming step and the outer layer forming step are not limited to the above methods, and the outer layer 12 covering at least the marker 40 and the coil layer 30 is disposed on the outer periphery of the inner layer 11 to form the tubular body 10. As long as it is, any other method may be used. However, the tubular body 10 can be obtained inexpensively and efficiently by using the above method.

  Hereinafter, each step will be specifically described. First, in the present embodiment, in the inner layer forming step, the inner layer 11 is formed as a core wire by using the resin material 111 as described above on a cylindrical mandrel that is optionally subjected to a release treatment on the surface. Next, in the coil layer forming step, as shown in FIG. 5A, the wire material 31 is wound around the inner layer 11 at the winding pitch (distance between adjacent edges A, C1 to C3) as described above. . First, the close-to-edge distance C1 <C2 on the distal end side DE with the tightly wound portion 32 to be the coil layer 30 and the narrow space portion 33 with the close-to-edge distance A interposed and the separation distance B in between. <The wide space | interval part 34 interposing the distance C1-C3 between adjacent edges which becomes gradually wide with C3 is formed. The coil layer 30 around which the wire material 31 is wound is disposed substantially coaxially with the main lumen 20, and the spiral groove 112 and the concave groove 113 are formed on the outer peripheral surface of the inner layer 11 by being bitten into the inner layer 11. Therefore, the adhesiveness between the coil layer 30 and the inner layer 11 and the marker 40 and the inner layer 11 to be mounted later is improved. Next, in the concave groove forming step, the wire material 31 is cut using a laser between the narrow gap portion 33 and the separation distance B portion. Then, as shown in FIG. 5 (b), the groove 113 is exposed by removing the wire material 31 from the distal end side separation distance B portion and the wide interval portion 24 portion from the cut portion.

  Further, the wire material 31 may be wound up to the distal end side DE from the portion where the concave groove 113 is formed. In this case, the wire material 31 is cut with a laser between the narrow space portion 33 and the separation distance B portion, and between the formation portion of the concave groove 113 of the wide space portion 34 and the wire material 31 portion ahead of it. Then, the wire material 31 is removed only from the portion where the marker 40 is to be mounted. In such a method, the wire material 31 remains on the distal end side DE, but this wire material 31 also becomes a second coil layer (not shown) that reinforces the distal end side DE. In addition, since the wire material 31 is bitten into the inner layer 11, the wire material 31 on the distal end side DE does not easily fall off even if it is moved or heated in the outer layer forming step or other steps. Has no effect. In addition, a separation distance B is provided between the coil layer 30 and the marker 40 to clarify the distinction between the coil layer 30 and the marker 40, and the length in the longitudinal direction of the marker 40 is set to a predetermined length in advance. deep. Thereby, even if the wire material 31 and the marker 40 on the distal end side are in contact with each other, the wire material 31 does not interfere with grasping the position of the marker 40.

  In the next marker mounting step, as shown in FIG. 5C, the wire material 31 is extracted from the wide space portion (the portion where the marker 40 is to be mounted) 34 in the concave groove forming step. Thereby, the ring-shaped marker 40 using the material which cannot transmit radiation, such as X-rays, is attached and fixed to the portion where the concave groove 113 of the inner layer 11 is exposed. In addition, since the wire material 31 after cutting is digging into the concave groove 113, it is difficult to drop off during transfer on the production line, but since the distance between adjacent edges C1 to C3 is wide, the number of turns of the wire material 31 is small. The wire material 31 can be removed from the concave groove 113 by rotating at a low rotational speed. Alternatively, the wire material 31 can be easily extracted from the groove 113 by simply pulling lightly. Further, since the springback force becomes remarkable, the drawing operation can be performed more easily, and the productivity is improved.

  Next, in the outer layer forming step, as described above, the resin material 121 formed in a tubular shape around the inner layer 11 including the marker 40 and the coil layer 30 is attached so as to cover the coil layer 30 and the marker 40. . Further, a heat shrinkable tube (not shown) is attached to the outer periphery and heated to heat shrink the heat shrinkable tube, and then the heat shrinkable tube is removed to form the outer layer 12. The outer layer 12 is formed of the same or different resin material 121 as the resin material 111 of the inner layer 11. Further, during the heat shrinkage of the heat shrinkable tube, as shown in the enlarged sectional view of FIG. 4, the resin material 121 of the outer layer 12 melts and enters between the marker 40 and the concave groove 113 of the inner layer 11, Solidify. By interposing the resin material 121, the adhesion between the marker 40 and the coil layer 30 and the inner layer 11 and the effect of suppressing the displacement of the marker 40 in the axial direction are improved. In the next coat layer forming step, the coat layer 50 is formed around the outer layer 12 by applying or chemically treating the resin material 51 as described above.

  In the present embodiment, in the marker mounting step, the marker 40 is fixed to the inner layer 11 by caulking, but the present application is not limited to this. The marker 40 is simply attached to the outer periphery of the concave groove 113 without being crimped, and the marker 40 is adhered to the inner layer 11 by filling the concave groove 113 with the resin material 121 of the outer layer 12 during heating in the subsequent outer layer forming step. It may be fixed. Further, as described above, a resin application step may be performed before the marker 40 is mounted, and the molten resin material 121 may be applied to a portion where the marker 40 is to be mounted. Thereafter, in a state where the resin material 121 is melted, a marker mounting process is performed, the marker 40 is mounted on the outer periphery of the concave groove 113 coated with the resin material 121, and the marker 40 is attached to the inner layer 11 by the solidification of the resin material 121. You may fix so that it cannot move to an axial direction. Alternatively, after the marker 40 is mounted, the melted resin material 121 is filled into the concave groove 113 and then solidified to fix the marker 40 and the inner layer 11 via the resin material 121, and then the outer layer forming step is performed. You may go.

  Finally, the mandrel is pulled out from the inner layer 11. At this time, if necessary, the mandrel is reduced in diameter by pulling both ends of the mandrel in opposite directions. By such a process, the tubular main body 10 including the main lumen 20, the inner layer 11, the outer layer 12, the coil layer 30, the marker 40, and the coat layer 50 can be obtained. And the catheter 100 of this embodiment can be manufactured by assembling this tubular main body 10 and the connector 60.

  Next, a bending example of the catheter 100 of this embodiment formed by the above manufacturing method will be described. When using the catheter 100 of this embodiment, first, for example, a guide wire is inserted into a blood vessel. Next, the catheter 100 can passively reach the affected area by inserting the catheter 100 into the blood vessel so as to follow the guide wire. When the wire is bent, the distal end 15 of the catheter 100 is bent as shown in the side view of FIG. 6B or 6C, following the bending of the wire. Can be made. In addition, since the marker 100 and the coil layer 30 are spaced apart from each other in the longitudinal direction in the catheter 100 of the present embodiment, it is easy to clearly check the marker 40 with X-rays or the like, and the distal end within the patient's body. It can be easily confirmed in which position the end DE is located. Further, due to the anchor effect of the concave groove 113, the positional deviation of the marker 40 in the axial direction can be suppressed even if such bending is performed.

  Further, in the catheter 100 according to the present embodiment, the coil layer 30 having elasticity by winding the wire material 31 is disposed around the main lumen 20. Therefore, when the catheter 100 is bent following the guide wire, an external force is applied to the wire material 31 of the coil layer 30 to bend its axial direction. However, the wire material 31 tries to resist the external force by its elastic repulsive force. For this reason, the sharp bending of the catheter 100 can be suppressed. Therefore, the sharp bending of the main lumen 20 can also be suppressed. Thereby, since the internal space cross-sectional area of the main lumen 20 can be maintained at a sufficient size, it is possible to suitably perform the supply of medicines and the like through the main lumen 20 and the insertion of the optical system.

  Moreover, in this embodiment, when winding the wire material 31, the close winding part 32 which contacted adjacent windings closely, and the winding adjacent to the distal end side DE continuously to this close winding part 32. A narrow space portion 33 is formed with a distance A between adjacent edges interposed therebetween. Accordingly, since the tightly wound portion 32 has relatively high bending rigidity, the axial direction is maintained substantially linear without being bent so much. In addition, the narrow space portion 33 has a relatively low bending rigidity, and thus has a good flexibility and is easily bent, and can hold the bent body. For this reason, in the narrow space | interval part 33 of the wire material 31, the bending operation of the distal end part 15 which followed the bending | flexion of the guide wire can be performed easily. In addition, since the closely wound portions 32 are in contact with adjacent windings, when the catheter 100 is pushed into the body cavity, the pushing force is effectively transmitted to the narrow space portion 33 via the densely wound portion 32. be able to. That is, the pushability of the catheter 100 can be improved. The pushability of the catheter 100 is further improved by the coil layer 30 made of the wire material 31 extending from the distal end portion to the proximal end portion of the main lumen 20. Furthermore, the pushability of the catheter 100 is significantly improved because the coil layer 30 is a densely wound portion 32 except for the narrow interval portion 33.

  As described above, in the present embodiment, since the anchor groove with respect to the marker 40 is obtained by the concave groove 113 and the resin material 121 filled in the concave groove 113, the axial direction of the marker 40 can be obtained during manufacturing and use. The positional deviation of is suppressed satisfactorily. Therefore, the catheter 100 which is excellent in manufacturing efficiency and excellent in operability can be provided at low cost. Even if the marker 40 is fixed in this manner, since the marker 40 and the coil layer 30 are separated from each other, the catheter 100 is not disturbed when the catheter 100 is bent, and smooth bending is possible. Further, even if the marker 40 is caulked, the inner layer 11 is not deformed toward the lumen at the portion where the coil layer 30 is disposed, so that the flatness of the main lumen 20 can be maintained.

  Moreover, in the said 1st Embodiment, as shown in FIG.1 and FIG.4, although the narrow space | interval part 33 winds the wire material 31 by equal pitch (distance A between adjacent edges), this application is limited to this. It will never be done. For example, as in Modification 1 of the catheter 101 shown in FIG. 7, the winding pitch of the spiral groove 112 of the narrow gap portion 33 that is a part of the coil layer 30 may be gradually increased toward the distal end side. That is, the relationship between the distance between the adjacent edges of the spiral groove 112 and the distance between the adjacent edges of the spiral groove 112 and the series of concave grooves 113 is A1 <A2 <A3 <A4 <A5 <C1 <C2 <C3. As described above, the distance between adjacent edges of the wire material 31 on the distal end side DE of the coil layer 30 is gradually increased, so that flexibility is maintained while maintaining rigidity. As a result, the flexibility on the distal end side DE side is improved.

  Moreover, in the said 1st Embodiment and the said modification 1, as shown in FIG.1, FIG.4 and FIG.7, the inner peripheral surface of the marker 40 is a smooth surface. However, the present application is not limited to this. For example, in Modification 2 of the catheter 102 shown in FIG. 8, a spiral protrusion 141 for screwing into the concave groove 113 is provided on the inner peripheral surface of the marker 140. Provided. Such a marker 140 is screwed into the concave groove 113 while rotating the marker 140 in the marker mounting step. By this screwing, the anchor effect of the marker 140 can be further improved. Note that the inner peripheral surface of the marker 140 is not limited to the protrusion 141 but may be formed with a groove (screwed on the protrusion between the grooves 113) or a rough surface. .

[Second Embodiment]
Next, a catheter according to the second embodiment will be described. FIG. 9 is a side sectional view of the distal end portion (distal end side DE) of the tubular main body 210 of the catheter 200 according to the second embodiment. FIG. 10 is an overall view of a catheter 200 according to the second embodiment and a side view showing an example of bending. FIG. 10A is a side view showing the whole before the catheter 200 is bent. FIG. 10B is a side view showing a state in which a slider 264a described later is operated to bend the tip upward. FIG. 10C is a side view showing a state in which the slider 264a is operated and the tip is bent upward with a larger curvature than that in FIG. 10B. FIG. 10D is a side view showing a state in which the slider 264b is operated to bend the tip downward. FIG. 10E is a side view showing a state in which the slider 264b is operated and the tip is bent downward with a larger curvature than that in FIG. 10D.

  The catheter 200 of the second embodiment has substantially the same configuration as the catheter 100 according to the first embodiment, and includes an inner layer 211 made of a resin material 2111 and an outer layer 212 made of a resin material 2112 as shown in FIG. The tubular main body 210, a main lumen 220 disposed in the longitudinal direction in the tubular main body 210, and an outer periphery of the main lumen 220 are formed of a material harder than a resin material forming the tubular main body 210. A coil layer 230 formed simultaneously with the spiral groove 2112 by winding the wire material 231, and a marker 240 mounted on the outer periphery of the concave groove 2113 formed on the distal end side DE of the tubular body 210. Yes. In addition, a coating layer 250 made of a hydrophilic resin material 251 whose outer surface is lubricated is provided as an outermost layer of the tubular main body 210 around the outer layer 212 at the distal end 215. The tubular body 210 and the operation unit 260 constitute the catheter 200 (see FIG. 10).

  Also in the present embodiment, the marker 240 is arranged on the distal end DE in the longitudinal direction of the tubular body 210 with respect to the coil layer 230 via the coil layer 230 and a separation distance B. Similarly to the first embodiment, the wire material 231 is wound so as to bite into the inner layer 211, and a spiral groove 2112 in which the coil layer 230 is disposed and a concave groove 2113 in which the marker 240 is mounted are formed in series. Yes. Further, when winding the wire material 231, the distances C1 to C3 between the adjacent edges of the concave groove 2113 in which the marker 240 is mounted are larger than the distance A between the adjacent edges of the spiral groove 2112 in which the coil layer 230 is disposed. Winding. Further, the adjacent edge distances C1 to C3 of the concave groove 2113 are also gradually increased so as to satisfy C1 <C2 <C3. Further, as shown in FIG. 9, the wire material 231 bites into the vicinity of the distal end portion 215. The depth is gradually reduced. That is, in the coil layer 230 portion, the biting depth b is substantially half of the thickness a of the inner layer 211, and for the concave groove 2113, the biting depths e1 to e3 having the distances C1 to C3 between adjacent edges are set to the distal end portion 215. It gradually becomes shallower (e1> e2> e3). By forming in this way, the coil layer 230 has excellent adhesion to the inner layer 211 and does not easily fall off. On the other hand, the wire material 231 disposed in the concave groove 2113 has a wide distance between adjacent edges C1 to C3, so that it becomes not only a standard for cutting but also gradually becomes shallower. Therefore, the portion of the cut root biting depth e1 bites into the inner layer 211 with such a strength that it does not fall off during transfer on the production line. When the wire material 231 is removed from the groove 2113, the distance between adjacent edges C1 to C3 is wide, so that the number of turns of the wire material 231 is small, and the biting depth is gradually shallower as e1 to e3. Accordingly, the wire material 231 can be easily removed from the groove 2113 by removing it by rotating it with a small number of rotations or by simply pulling it out. Also in this case, the wire material 231 can be removed from the groove 2113 more easily by the springback force of the wire material 231 and the manufacturability is excellent.

  In this embodiment as well, the inner peripheral surface of the marker 240 is a smooth surface. However, as in Modification 1 of the first embodiment shown in FIG. 7, protrusions, grooves, and roughness are provided on the inner peripheral surface of the marker 240. Etc. may be provided. Moreover, although the coil layer 230 and the marker 240 were formed in the same layer, the coil layer 230 is arrange | positioned inside the marker 240 in this embodiment.

  In addition, as a configuration in which the second embodiment is particularly different from the first embodiment, a sub-lumen 280 is provided outside the coil layer 230. As shown in FIG. 9, the sub-lumen 280 is provided in the outer layer 212 and has a smaller diameter than the main lumen 220 and is formed as a hollow extending in the longitudinal direction of the catheter 200. That is, the sub-lumen 280 is disposed around the main lumen 220. Hereinafter, the structure of the sub-lumen 280 and the manufacturing method thereof will be described.

  Here, the number of sublumens 280 is arbitrary, but the catheter 200 of the present embodiment has two sublumens 280. In the case of having a plurality of sub-lumens 280, the sub-lumens 280 are arranged in a distributed manner around the axis of the main lumen 220. When the catheter 200 includes two sub-lumens 280 as in this embodiment, the sub-lumens 280 are preferably arranged around the main lumen 220 at intervals of 180 degrees as shown in FIG. The catheter 200 may include three or more sub-lumens 280. For example, when three sub-lumens 280 are provided, the sub-lumens 280 are preferably arranged around the main lumen 220 at intervals of 120 degrees.

  The sub-lumen 280 is open at least at the proximal end CE of the tubular body 210, specifically, for example, at the proximal end PE of the tubular body 210 as shown in each drawing of FIG. In addition, you may open in the distal end side DE rather than the proximal end side PE of the tubular main body 210. FIG. The operation lines 270 are inserted into the respective sub-lumens 280, and the operation lines 270 are slidable with respect to the sub-lumen 280.

  Further, the distal end of the operation line 270 is fixed to the distal end 215 of the catheter 200. A mode of fixing the distal end of the operation line 270 to the distal end 215 is not particularly limited. For example, as shown in FIG. 9, the tip (distal end 271) of the operation line 270 may be connected to the marker 240. Moreover, you may weld to parts other than the marker 240 in the distal end part 215. Alternatively, the marker 240 or the distal end 215 of the tubular body 210 may be adhered and fixed with an adhesive.

  The operation line 270 is guided in the sub-lumen 280 from the distal end of the tubular body 210 to the proximal end 216. The proximal end (not shown) of the operation line 270 is led out from the opening of the sub-lumen 280 in the proximal end PE of the tubular main body 210, and is fixed to sliders 264a and 264b of the operation unit 260 described later.

  The slider 264 of the operation unit 260 is operated in the direction of pulling the proximal end of the operation line 270 (that is, the right direction in FIG. 10). Then, a tensile force is applied to the distal end portion 215 of the catheter 200 via the operation line 270, and the distal end portion 215 is bent toward the sub-lumen 280 through which the operation line 270 is inserted. However, even if the slider 264 of the operation unit 260 is operated in the direction in which the proximal end of the operation line 270 is pushed into the catheter 200 (that is, the left direction in FIG. 10), the operation line 270 moves from the operation line 270 to the distal end 215. On the other hand, the pushing force is not substantially applied.

  A sub-lumen 280 through which the operation line 270 is inserted is provided away from the main lumen 220 in the outer diameter direction. Therefore, when supplying a medicine or the like through the main lumen 220 or inserting the optical system, they can be prevented from leaking into the sub-lumen 280. Then, by providing the sub-lumen 280 on the outer side of the coil layer 230 as in the present embodiment, the inner side of the coil layer 230, that is, the main lumen 220 is protected against the sliding operation line 270.

  Here, as a method of inserting the operation line 270 into the sub-lumen 280, for example, the operation line 270 may be inserted from one end side of the tubular body 210 of the catheter 200 on which the sub-lumen 280 is formed in advance. . Alternatively, when the tubular body 210 is extruded, the operation line 270 may be extruded together with the resin material and inserted into the sub-lumen 280.

  When the operation line 270 is extruded together with the resin material and inserted into the sub-lumen 280, the operation line 270 is required to have heat resistance equal to or higher than the melting temperature of the resin material constituting the tubular body 210. In the case of the operation line 270, specific materials include, for example, polyether ether ketone (PEEK), polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), polymer fibers such as PI or PTFE, or stainless steel. (SUS), steel wire coated with corrosion resistance, metal wire such as titanium or titanium alloy can be used.

  On the other hand, when heat resistance is not required for the operation wire 270, such as when the operation wire 270 is inserted into the sub-lumen 280 of the tubular body 210 that has been molded in advance, in addition to the above materials, PVDF, high-density polyethylene (HDPE) or polyester can also be used.

  Here, typical dimensions of the catheter 200 of the present embodiment will be described. The radius of the main lumen 220 is about 200 to 300 μm, the thickness of the inner layer 211 is about 10 to 30 μm, the thickness of the outer layer 212 is about 100 to 220 μm, the outer diameter of the coil layer 230 is 500 to 860 μm, and the inner diameter of the coil layer 230 Can have a diameter of 420-660 μm. The radius from the axial center (of the tubular body 210) of the catheter 200 to the center of the sublumen 280 can be about 300 to 450 μm, the inner diameter of the sublumen 280 can be 40 to 100 μm, and the thickness of the operation line 270 is It can be 30-60 micrometers. And the outermost radius (of the tubular main body 210) of the catheter 200 can be made into about 350-490 micrometers.

  That is, also in this embodiment, as in the first embodiment, the outer diameter of the catheter 200 is less than 1 mm in diameter, and can be inserted into a blood vessel such as a celiac artery. Further, the catheter 200 of the present embodiment is operated freely by pulling the operation line 270, so that the catheter 200 can be advanced in a desired direction even in a branching blood vessel, for example.

  As shown in each drawing of FIG. 10, the proximal end 216 of the catheter 200 is provided with an operation unit 260. The operation unit 260 of the present embodiment includes a shaft portion 261 extending in the longitudinal direction of the catheter 200 and a slider 264 (for example, the first and second sliders 264a) that advance and retreat in the longitudinal direction of the catheter 200 with respect to the shaft portion 261, respectively. 264b), a handle portion 262 that rotates around the axis of the shaft portion 261 integrally with the shaft portion 261, and a grip portion 263 into which the base end portion of the tubular body 210 is inserted so as to be rotatable around the axis. Yes. A proximal end side PE of the tubular body 210 is fixed to the shaft portion 261. The distal end 215 of the catheter 200 can be bent by performing an operation of pulling a plurality of operation lines 270 individually or simultaneously on the slider 264 of the operation unit 260. It has become. Further, for example, the entire tubular body 210 is rotated together with the shaft portion 261 by rotating the handle portion 262 with respect to the grip portion 263 with the other hand while holding the grip portion 263 with one hand. Can be done.

  Here, as described above, in the case of the present embodiment, the catheter 200 has two sub-lumens 280 and the operation lines 270 inserted through the sub-lumens 280, respectively. Hereinafter, for the convenience of explanation, one sub-lumen 280 is referred to as a first sub-lumen 280a, and the other sub-lumen 280 is referred to as a second sub-lumen 280b (see FIGS. 9 and 10). The operation line 270 inserted into the first sub-lumen 280a is referred to as a first operation line 270a, and the operation line 270 inserted into the second sub-lumen 280b is referred to as a second operation line 270b.

  The proximal end of the first operation line 270a is connected to the first slider 264a of the operation unit 260. Similarly, the proximal end of the second operation line 270b is connected to the second slider 264b of the operation unit 260. Then, the first slider 264a and the second slider 264b are individually slid toward the base end side with respect to the shaft portion 261. By this operation, the first operation line 270a or the second operation line 270b connected to each is pulled individually, and a tensile force is applied to the distal end portion 215 of the catheter 200 (that is, the distal end side DE of the tubular body 210). Given. As a result, the distal end 215 is bent toward the pulled operation line 270.

  When individually pulling the operation line 270 of the first operation line 270a or the second operation line 270b, the curvature of the distal end portion 215 can be changed according to the distance to be pulled. When the distal end 215 cannot be bent to a desired posture by merely pulling the operation lines 270 individually, the first and second operation lines 270a and 270b are simultaneously pulled to A desired posture of the end 215 may be realized.

  In this way, the distal end portion 215 is bent into various shapes, and the rotational phase of the tubular body (sheath) 210 is adjusted by a rotation operation with respect to the handle portion 262. By this operation, the bending amount and bending direction of the distal end portion 215 can be adjusted, and the catheter 200 can be freely entered into a body cavity that branches at various angles. Therefore, for example, the catheter 200 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 200 of this embodiment, it is preferable that the bending angle of the distal end portion 215 exceeds 90 degrees (see FIG. 10). 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 200 can be made to approach this branch branch.

  Next, a bending example of the catheter 200 according to the second embodiment will be described with reference to FIG. First, the catheter 200 of this embodiment is inserted into a body cavity such as a blood vessel of a patient. In the present embodiment, the first sub-lumen 280a and the second sub-lumen 280b are formed so as to face each other by 180 degrees with the axis of the catheter 200 interposed therebetween. The first operation line 270a is inserted through the first sub-lumen 280a, and the second operation line 270b is inserted through the second sub-lumen 280b, so that the tip can be freely bent. Therefore, unlike the first embodiment, a guide wire or the like is not required, and the catheter 200 can be actively inserted into the patient's body while operating the operation line.

  Here, in the catheter 200 of the present embodiment, when the first operation line 270a is pulled to the proximal end CE by operating the slider 264a of the operation unit 260, as shown in FIG. The distal end 215 bends upward in FIG. Further, when this pulling amount is increased, the distal end portion 215 of the catheter 200 is greatly bent upward in FIG. 10 as shown in FIG.

  Further, when the slider 264b of the operation unit 260 is operated to pull the second operation line 270b toward the proximal end CE, the distal end 215 of the catheter 200 is moved as shown in FIG. Bend downward. Further, when this pulling amount is increased, the distal end portion 215 of the catheter 200 is greatly bent downward in FIG. 10 as shown in FIG.

  Note that when the first operation line 270a and the second operation line 270b are towed together, the towing amounts may be different from each other. In other words, if a desired curvature is not achieved by pulling any of the operation lines 270 individually, the curvature may be adjusted by pulling both the operation lines 270. More specifically, one of the operation lines 270 is pulled from a state where the distal end portion 215 is bent by pulling any one of the operation lines 270. By this operation, an operation for reducing the bending amount of the distal end portion 215 and an operation for returning the posture of the distal end portion 215 from the bent state to the original linear posture can be performed. In this way, the bending amount can be finely adjusted by the operation of reducing the bending amount.

  Further, in a state where the distal end portion 215 of the catheter 200 is bent, the grasping portion 263 of the operation unit 260 is grasped with one hand, and the handle portion 262 is rotated with respect to the grasping portion 263 with the other hand. . By this operation, the entire catheter 200 is rotated together with the shaft portion 261 by a maximum of 90 degrees, the operator changes the bending direction of the distal end portion 215 of the catheter 200 to a desired direction, and the distal end side DE becomes the affected part. Can be opposed. In this embodiment as well, since the wire material 231 is wound around the main lumen 220, the torsional rigidity of the tubular body 210 is increased. Therefore, the torque transmission efficiency during the rotation operation of the catheter 200 is increased, and the rotation response of the distal end 215 to the rotation operation is improved. Furthermore, since the position of the marker 240 can be clearly confirmed by being separated from the coil layer 230 in the longitudinal direction, the operation can be performed while easily confirming the current position and orientation of the distal end side DE.

  Further, in the catheter 200 according to the second embodiment, the coil layer 230 having elastic force is formed by winding the wire material 231 around the main lumen 220. Therefore, when the catheter 200 is bent by an operation on the operation line 270, an external force is applied to the coil layer 230 to bend its axial direction. However, the coil layer 230 tries to resist the external force by its elastic repulsive force. For this reason, the sharp bending of the catheter 200 can be suppressed. Therefore, the sharp bending of the main lumen 220 can also be suppressed. As a result, the lumen cross-sectional area of the main lumen 220 can be maintained at a sufficient size, so that it is possible to suitably supply a medicine or the like through the main lumen 220 or insert an optical system.

  Further, since the main lumen 220 maintains the inner air cross section, it is possible to suppress the sudden bending of the sub-lumen 280. Thereby, since the increase in the friction coefficient between the inner peripheral wall of the sub-lumen 280 and the operation line 270 can be suppressed, the bending operability of the catheter 200 using the operation line 270 can be maintained in a good state, and the operation line 270 is disconnected. Can also be suppressed. However, since the coil layer 230 can be bent according to an external force that attempts to bend its axial direction, the bendability of the catheter 200 can be sufficiently ensured. In short, steep bends of the catheter 200 can be suppressed by the elastic repulsive force of the coil layer 230 while sufficiently ensuring the flexibility of the catheter 200.

  Also in the present embodiment, the wire material 231 is wound around at least the front end portion of the main lumen 220. Therefore, at the distal end portion 215 of the catheter 200, it is possible to suppress the sharp bending of the catheter 200 while ensuring sufficient flexibility of the catheter 200.

  Further, the coil layer 230 may be formed so as to have a narrow interval portion including the tip portion of the wire material 231 and a densely wound portion with a dense winding pitch, as in the first embodiment. With this configuration, in the narrow space portion of the wire material 231, the pulled operation line 270 side exhibits a behavior of being compressed, so that the bending operation of the distal end portion 215 by pulling the operation line 270 can be easily performed. Further, the pushability of the catheter 200 is improved by the coil layer 230 as in the first embodiment.

  Also in this embodiment, the marker 240 is arranged farther from the coil layer 230 on the distal end side DE in the longitudinal direction. Therefore, when the distal end of the catheter 200 is bent, the marker 240 and the coil layer 230 do not interfere with each other, and a smooth bending can be realized. Furthermore, the thickness of the entire catheter 200 can be reduced (thinned), and the lumen of the main lumen 220 can be flattened.

  Also in the present embodiment, since the marker 240 is spaced from the coil layer 230 on the distal end side DE in the longitudinal direction, the marker 240 and the coil layer 230 are bent when the tip of the catheter 200 is bent. Can be smoothly bent without interfering with each other. Furthermore, the thickness of the entire catheter 200 can be reduced (thinned), and the lumen of the main lumen 220 can be flattened. In addition, when the operation line 270 is pulled to bend the catheter 200, it is assumed that the marker 240 is also pulled and the marker 240 is displaced, but in the present application, the marker 240 is moved due to the anchor effect of the concave groove 2113. There is no misalignment. Therefore, usability and durability of the catheter 200 can be improved.

  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 the second embodiment, the example in which the catheter 200 has the two operation lines 270 (the first operation line 270a and the second operation line 270b) has been described. However, as described above, three or more sub-lumens 280 through which the operation lines 270 are inserted may be formed in the tubular main body 210. In this case, the bending operation of the catheter 200 can be performed by pulling one or more of these operation lines 270. In this case, the distal end 215 can be bent in any direction over 360 degrees by individually controlling the pulling lengths of the three or more operation lines 270. Thus, the catheter 200 can be entered only by pulling the operation line 270 by the operation unit 260 without performing a rotation operation to apply a rotational force to the entire catheter 200 and direct the distal end portion 215 in a predetermined direction. The direction can be manipulated.

  In addition, the catheter 200 may have a configuration having only one operation line 270. Also in this case, the distal end 215 can be bent in an arbitrary bending amount and in an arbitrary direction by using the bending operation of the distal end 215 by pulling the operation line 270 and the rotating operation of the catheter 200 together.

10, 210 Tubular body (sheath)
11, 211 Inner layer 111, 2111 Resin material 12, 212 Outer layer 121, 2121 Resin material 15, 215 Distal end 16, 216 Proximal end 20, 220 Main lumen 30, 230 Coil layer 31, 231 Wire material 40, 140 , 240 Marker 112, 2112 Spiral groove 113, 2113 Concave groove 100, 101, 102, 200 Catheter A, A1, A2, A3, A4, A5 Distance between adjacent edges (winding pitch)
B Separation distance (winding pitch)
C1, C2, C3 Distance between adjacent edges (winding pitch)
D Outer diameter DE Distal end side PE Proximal end side CE Proximal end side

Claims (16)

A catheter having a long tubular body having a main lumen inside and formed of a resin material,
The tubular body is
An inner layer having the main lumen inside;
A coil layer formed by winding a wire material in a spiral groove formed on the outer peripheral surface of the inner layer;
An outer layer covering the coil layer;
A catheter comprising: a concave groove formed in a series with the spiral groove near the distal end of the inner layer, and having a spiral pitch gradually increased toward the distal end.   The catheter according to claim 1, wherein a marker is mounted on the outer periphery of the concave groove.   The catheter according to claim 1 or 2, wherein the coil layer is formed by winding a wire material so as to bite to a depth that is approximately half the thickness of the inner layer.   The catheter according to any one of claims 1 to 3, wherein the coil layer is formed by expanding a winding pitch of a wire material toward the vicinity of the distal end portion.   The coil layer is configured to gradually reduce the depth of penetration of the wire material into the inner layer when the wire material is wound with the winding pitch widened toward the vicinity of the distal end. The catheter according to claim 4.   The concave groove has at least a distal end side with the widest winding pitch among the coil layers formed by winding the wire material with a winding pitch extended to the distal end portion of the inner layer. The catheter according to any one of claims 1 to 5, which is formed by removing one turn.   The catheter according to any one of claims 2 to 6, wherein a marker is mounted on an outer periphery of the concave groove, and the marker is disposed apart from the coil layer.   The catheter according to any one of claims 2 to 7, wherein a marker is mounted on an outer periphery of the concave groove, and the marker is formed in the same layer as the coil layer. A method for producing a catheter comprising a long tubular body having a main lumen inside and formed of a resin material,
Forming an inner layer on the outer periphery of the core wire;
Forming a coil layer on a spiral groove formed by winding a wire material around the outer peripheral surface of the inner layer;
Forming a series of the spiral groove near the distal end of the inner layer, and forming a concave groove having a gradually increased spiral pitch in the direction of the distal end;
Forming an outer layer on the outer peripheral surface of the inner layer including the coil layer and the concave groove,
The manufacturing method of the catheter which has the process of forming the said tubular main body.   The catheter manufacturing method according to claim 9, further comprising a step of attaching a marker on the outer periphery of the concave groove. The coil layer is formed by winding a wire material so as to bite into the inner layer up to the distal end of the outer periphery of the inner layer,
The catheter manufacturing method according to claim 9 or 10, wherein the concave groove is formed by removing at least one turn of the wire material in the vicinity of the distal end portion.   The method of manufacturing a catheter according to claim 11, wherein the wire material is wound so as to bite to a depth that is approximately half of the inner layer.   The said coil layer winds the said wire material so that the winding pitch of the said wire material becomes large gradually, so that it is close to the said distal end part, It is characterized by the above-mentioned. A method for manufacturing a catheter.   The wire material gradually reduces the depth of biting of the wire material into the inner layer when the wire material is wound with a winding pitch gradually widened toward the vicinity of the distal end portion. 14. The method for producing a catheter according to any one of 13 above.   The method further includes a step of mounting a marker on the outer periphery of the concave groove, and a step of applying the same resin material as the resin material forming the outer layer between the concave groove and the marker. The method for producing a catheter according to any one of claims 10 to 14, wherein:   Mounting the marker on the outer periphery of the groove, and forming the outer layer, and forming the outer layer between the groove and the marker when forming the outer layer. The method for producing a catheter according to any one of claims 10 to 15, wherein a resin material is filled.

Images