JP2019097598A - Catheter and manifold - Google Patents

Abstract

To provide a catheter and manifold in which a stylet is hardly displaced.SOLUTION: There is provided a catheter 1 comprising: a cylindrical member 5; a manifold body 11 which has a lumen 12 extending in a far-near direction, and is connected to a proximal end part of the cylindrical member 5; and a stylet 20 extending in a far-near direction and capable of being inserted into the lumen 12. A proximal end part of the stylet 20 has a zone (folding zone) 21 folded toward the distal side. There is also provided a manifold 10 which can be used with the stylet 20 extending in the far-near direction and capable of being inserted into the cylindrical member 5 and which is connected to the proximal end part of the cylindrical member 5. The manifold has the manifold body 11 extending in the far-near direction and having a lumen 12, and there is provided an opening 13 into which the proximal end part of the stylet 20 is inserted, on a proximal part of the manifold body 11 and on a radial outside of a center axis C of the lumen 12.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a catheter having a stylet that increases the rigidity on the proximal side, and a manifold used therefor.

  In order to increase the rigidity on the proximal side of the catheter to form a stable shape, as shown in Patent Document 1, a linear member called a stylet is inserted into the catheter.

  As a method of fixing a stylet in a catheter, for example, Patent Document 1 discloses a catheter connector (manifold) capable of fixing a catheter at the proximal end of the catheter and a catheter connector, which can be fitted to the catheter connector. It is disclosed that a stylet connector is provided which can fix the stylet passing through the cavity. In particular, the proximal end of the stylet is bent approximately 90 degrees and the tip is secured to the stylet connector. Fixing the stylet in this way prevents the stylet from falling off the proximal side of the catheter.

JP 2003-284780 A

  However, even if the stylet is fixed by the method described in Patent Document 1, the stylet is displaced in the tube during operation of the catheter, and insertion of a member such as a guide wire into the tubular member, or a drug solution In some cases, it is difficult to inject a contrast agent or the like. Then, an object of this invention is to provide the catheter and manifold in which a stylet does not displace easily.

  The catheter of the present invention, which has solved the above problems, has a tubular member and a lumen extending in a perspective direction, and is connected to the proximal end of the tubular member and a manifold body A catheter having a stylet that extends in a perspective direction and is penetrable through the lumen, wherein the proximal end of the stylet is folded back towards the distal end It has a gist in the point which has (it may call a "turning section" hereafter). In the catheter of the present invention, since the folded back section of the stylet can be easily engaged with the manifold body, the stylet is less likely to be displaced even if the catheter is operated, and insertion of other members into the tubular member Injection can be performed smoothly.

  In the above catheter, it is preferable that an opening into which the proximal end of the stylet can be inserted is formed on the proximal side of the manifold body and radially outward of the central axis of the lumen.

  In the above catheter, the opening preferably extends in the perspective direction.

  Preferably, in the above catheter, the opening further extends along the radial direction of the manifold body.

  In the above catheter, the opening preferably extends along the circumferential direction of the manifold body.

  Preferably, in the above catheter, the proximal end of the stylet is arranged to face the distal side of the manifold body.

  In the above catheter, preferably, the proximal end of the stylet is folded back in a U-shape.

  The present invention also provides a manifold for use with a stylet that extends in a perspective direction and is insertable through the tubular member and connected to the proximal end of the tubular member. The manifold of the present invention has a manifold body extending in a perspective direction and having a lumen, the proximal portion of the manifold body being radially outward of the central axis of the lumen, of the stylet The present invention is summarized in that an opening through which the proximal end can be inserted is formed. According to the manifold of the present invention, by inserting the proximal end of the stylet into the opening of the manifold body, it is easy to engage the manifold body with the stylet, so the stylet is less likely to be displaced even if the catheter is operated. Thus, it is possible to smoothly insert other members into the tubular member and inject a drug solution or the like.

  According to the catheter and the manifold of the present invention, since the manifold body and the stylet can be easily engaged, the stylet is hardly displaced even if the catheter is operated, and other members are inserted into the tubular member, the drug solution, etc. Injection can be performed smoothly.

The sectional view (one part side view) showing the structure by the side of the proximal side of the catheter concerning an embodiment of the invention is expressed. FIG. 2 shows a cross-sectional view along line II-II of the catheter shown in FIG. FIG. 2 depicts an enlarged side view of the proximal end of the stylet shown in FIG. 13 shows a rear view showing a modification of the opening of the manifold shown in FIG. 13 shows a rear view showing another modification of the opening of the manifold shown in FIG. FIG. 7 shows a side view showing a modification of the stylet shown in FIG. 3; FIG. 7 is a side view showing another modification of the stylet shown in FIG. 3;

  The catheter of the present invention has a tubular member and a lumen extending in a perspective direction, and the manifold body connected to the proximal end of the tubular member extends in a perspective direction A catheter having a stylet insertable into the lumen of the manifold body, the section in which the proximal end of the stylet is folded back toward the distal side (folded section) have. In the catheter of the present invention, since the folded back section of the stylet can be easily engaged with the manifold body, the stylet is less likely to be displaced even if the catheter is operated, and insertion of other members into the tubular member Injection can be performed smoothly.

  Also, the manifold of the present invention is used with a stylet that extends in the perspective direction and can be inserted into the tubular member, and is connected to the proximal end of the tubular member in the perspective direction. An opening having a manifold body extending and having a lumen, the proximal end of the manifold body being insertable into the proximal end of the stylet radially outward of the central axis of the lumen Is formed. According to the manifold of the present invention, by inserting the proximal end of the stylet into the opening of the manifold body, it is easy to engage the manifold body with the stylet, so the stylet is less likely to be displaced even if the catheter is operated. Thus, it is possible to smoothly insert other members into the tubular member and inject a drug solution or the like.

  Hereinafter, the present invention will be more specifically described based on the following embodiments, but the present invention is not limited by the following embodiments as a matter of course, and modifications can be appropriately made within the scope which can conform to the above and below. In addition, it is of course possible to carry out, and all of them are included in the technical scope of the present invention. In addition, in each drawing, although hatching, a member code | symbol, etc. may be abbreviate | omitted for convenience, in this case, a specification and other drawings shall be referred to. In addition, the dimensions of various members in the drawings may differ from the actual dimensions, as priority is given to helping to understand the features of the present invention.

  In the present invention, a catheter refers to a medical catheter in general, and includes a balloon catheter, a microcatheter, a penetration catheter, and an aspiration catheter. The catheter is preferably used to inject a contrast medium in an examination (Endoscopic retrograde cholangiopancreatography: ERCP) for imaging the bile duct or pancreatic duct with an endoscope. The proximal side of the catheter refers to the direction on the proximal side of the user (operator) with respect to the extension direction of the catheter, and the distal side refers to the opposite direction on the proximal side (that is, the direction to be treated) . Further, the direction from the proximal side to the distal side of the catheter is referred to as a perspective direction or an axial direction.

  Hereinafter, a catheter according to an embodiment of the present invention will be described with reference to FIGS. 1 to 7. 1 is a cross-sectional view (partly a side view) showing the structure of the proximal side of the catheter, FIG. 2 is a cross-sectional view along the line II-II of the catheter shown in FIG. FIG. 10 is an enlarged side view of the proximal end of the stylet shown. 4 to 5 are rear views showing modifications of the opening of the manifold body shown in FIG. 1, and FIGS. 6 to 7 are side views showing modifications of the stylet shown in FIG. 4 to 5, the screw thread provided on the outer peripheral surface of the manifold body is omitted.

  As shown in FIG. 1, the catheter 1 according to the embodiment of the present invention has a tubular member 5, a manifold body 11 and a stylet 20. Further, the manifold 10 according to the embodiment of the present invention is used together with the stylet 20 which can be inserted into the cylindrical member 5, and has the manifold body 11.

  The tubular member 5 has a distal side and a proximal side. A resin tube is mentioned as the cylindrical member 5, The resin tube can be manufactured by extrusion molding, for example. Examples of the resin constituting the tubular member 5 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorine resins, vinyl chloride resins, silicone resins, natural rubber and the like. These may use only 1 type and may use 2 or more types together. Among them, polyamide resins, polyester resins, polyurethane resins, polyolefin resins and fluorine resins are preferably used.

  The cylindrical member 5 may be comprised from a single | mono layer, and may be comprised from multiple layers. The cylindrical member 5 may be configured such that a part in the axial direction or circumferential direction is composed of a single layer, and the other part is composed of a plurality of layers.

  The manifold 10 is connected to a syringe or the like for injecting a contrast agent or a medicine into the tubular member 5. The manifold 10 has a manifold body 11. The manifold 10 may include a lid member 32 described later, an elastic member 34, and a seal member 35. The manifold body 11 has a lumen 12 extending in a perspective direction, and is connected to the proximal end of the tubular member 5.

  The manifold body 11 preferably has a plurality of lumens. As shown in FIG. 1, the lumen 12 of the manifold main body 11 may have a main lumen 12A extending in the perspective direction and a sub lumen 12B branched from the main lumen 12A. In that case, it is preferable that the stylet 20 be inserted into the main lumen 12A.

  The axial direction of the auxiliary lumen 12B may be inclined, for example, in the range of 20 degrees to 80 degrees with respect to the axial direction of the main lumen 12A. In FIG. 1, the sub lumen 12B is provided such that the axial direction of the sub lumen 12B is inclined 60 degrees with respect to the axial direction of the main lumen 12A.

  Preferably, the inner diameter at the proximal end of the lumen extending in the perspective direction of the manifold body 11 (main lumen 12A in FIG. 1) is larger than the inner diameter at the distal end. An elastic member 34 may be disposed at the proximal end of the main lumen 12A of the manifold body 11 to additionally secure the stylet 20. The elastic member 34 will be described later.

  As a material which comprises the manifold main body 11, synthetic resin, such as ABS and a polycarbonate, and foam plastics, such as a polyurethane foam, can be used, for example.

  Preferably, the tubular member 5 is connected to the distal end of the manifold body 11. The cylindrical member 5 and the manifold body 11 may be directly connected. In addition, as shown in FIG. 1, indirectly via a connecting member 30, one end of which is inserted into the distal end of the manifold body 11 and the other end of which is inserted into the proximal end of the tubular member 5. It may be connected. The connection member 30 may be a pipe made of stainless steel.

  As shown in FIG. 1, it is preferable that the proximal end of the tubular member 5 and the distal end of the manifold body 11 be disposed in the hollow protective member 31. As a result, it is possible to prevent the tubular member 5 and the manifold main body 11 from being buckled due to the rapid change of the shape of the tubular member 5 to the manifold 11. The protective member 31 preferably has a slope such that the outer diameter decreases toward the distal side, and more preferably has a cone shape or a frustum shape. The protective member 31 can be made of an elastic material such as silicone rubber or polyamide elastomer.

  In order to facilitate connection of the protective member 31 to the manifold body 11, it is preferable that a small diameter portion 14 having an outer diameter smaller than that of the proximal end be provided on the distal side of the manifold body 11. In order to enhance the fit with the protective member 31, an annular convex portion 15 may be formed on the outer peripheral surface of the small diameter portion 14.

  The stylet 20 is a linear member that can be inserted into the lumen 12 of the manifold body 11 and the lumen 6 of the tubular member 5 in order to increase the rigidity of the catheter 1. The stylet 20 extends at least partially in the perspective direction. The stylet 20 may be a single wire, a plurality of single wires bundled or twisted together. In addition, the stylet 20 may have a wire formed in a coil shape.

  Although not shown, the distal end of the stylet 20 is preferably located proximal to the distal end of the tubular member 5 and proximal to the axial center of the tubular member 5 More preferably, This makes it possible to increase the rigidity of the proximal side of the catheter 1 while making the distal side of the tubular member 5 flexible.

  The proximal end of the stylet 20 has a section (folded section 21) that is folded back toward the distal side. Since the folded section 21 of the stylet 20 can be easily engaged with the manifold body 11, the stylet 20 is less likely to be displaced even if the catheter 1 is operated, and insertion of other members into the tubular member 5, Injection can be performed smoothly.

  The folded back section 21 is preferably provided at a portion including the proximal end 22 of the stylet 20, but may be provided more distal than the proximal end 22 of the stylet 20.

  The number of folding sections 21 is not particularly limited, and may be, for example, three or less. However, since the space in the manifold body 11 is limited, only one folding section 21 is provided in the stylet 20. Is preferred.

  The folding section 21 may have a length that engages with the manifold body 11, and the length of the folding section 21 is, for example, 1% or less, 0.5% or less, or 0.3% of the total length of the stylet 20 The following can be made.

  As shown in FIG. 1, it is preferable that the turnback section 21 of the stylet 20 be disposed radially outward of the central axis of the cylindrical member 5, and the entire stylet 20 be closer to the central axis of the cylindrical member 5. More preferably, they are disposed radially outward. As a result, the lumen 12 of the manifold body 11 and the lumen 6 of the tubular member 5 can be widely secured. Therefore, the insertion of other members into the tubular member 5 and the injection of a drug solution can be performed more smoothly. .

  It is preferable that the stylet 20 extends along the perspective direction at the distal side of the folding section 21. This makes it easier to insert the main lumen 12A of the manifold body 11, which extends along the perspective direction, on the more distal side than the folded section 21 of the stylet 20. The stylet 20 is preferably straight. When the stylet 20 is straight, interference with the guide wire inserted into the tubular member can be reduced. The stylet 20 may be curvilinear, such as corrugated. For example, it may be in a spiral shape to contact the lumen 6 of the tubular member 5.

  The stylet 20 can be made of, for example, a metal material such as stainless steel or a Ni-Ti alloy.

  In order to engage and fix the folded section 21 of the stylet 20 to the manifold body 11, it is preferable that the manifold body 11 be formed with an opening 13 capable of receiving the folded section 21 of the stylet 20. Specifically, an opening 13 into which the proximal end of the stylet 20 can be inserted is a proximal portion of the manifold body 11 and radially outward of the central axis C of the lumen 12 (main lumen 12A). More preferably, it is formed. The manifold body 11 and the stylet 20 can be engaged and fixed by inserting the turnback section 21 of the stylet 20 into such an opening 13.

  The stylet 20 is inserted into the main lumen 12 A of the manifold body 11, and the folded section of the stylet 20 is inserted into the opening 13 of the manifold body 11. The main lumen 12A and the opening 13 may be continuously formed as shown in FIG. 4 or may be separately formed as shown in FIG. When a portion between the main lumen 12A and the opening 13 is provided in the manifold body 11, the portion may have a lumen that encloses the outer periphery of the stylet 20. You may have the groove | channel which touches a part.

  Although not shown, the opening 13 may be formed to penetrate the manifold body 11. In that case, the opening 13 communicates with the outside of the manifold body 11. However, when flowing a liquid such as a chemical solution to the inner cavity 6 of the tubular member 5 through the main lumen 12A of the manifold body 11, the opening 13 is an inner wall of the manifold body 11 to prevent the liquid from leaking out through the opening 13. Is preferably provided.

  As shown in FIG. 1, the opening 13 preferably extends along the perspective direction. A portion of the opening 13 may extend along the perspective direction, or the entire opening 13 may extend along the perspective direction. Thereby, the folded section 21 of the stylet 20 can be easily inserted into the opening 13.

  Preferably, the length L 1 of the opening 13 is shorter than the length L 2 of the turnback section 21 in the direction of the manifold main body 11. As a result, when the catheter 1 is viewed from the proximal side, the folded section 21 of the stylet 20 is disposed so as to project from the opening 13, which facilitates the placement and removal of the stylet 20.

  Although not shown, the length L 1 of the opening 13 may be longer than the length L 2 of the turnback section 21 in the perspective direction of the manifold body 11. As a result, when the catheter 1 is viewed from the proximal side, the folded section 21 of the stylet 20 is disposed further to the distal side than the proximal end of the opening 13, so that the stylet 20 does not easily come off the opening 13.

  As shown in FIG. 1, the opening 13 of the manifold body 11 is preferably formed along the shape of the turnback section 21 of the stylet 20. As a result, the stylet 20 is easily fixed to the manifold body 11, and the stylet 20 can be prevented from being displaced.

  As shown in FIGS. 1 and 3, a section (opposite section 23) facing the folded section 21 of the stylet 20 in the direction of the manifold main body 11 forms a main lumen 12A of the manifold main body 11. It is preferable to be in contact with the inner wall. By bringing a part of the stylet 20 into contact with the inner wall of the manifold body 11 in this manner, the stylet 20 can be easily disposed radially outward of the central axis C of the main lumen 12 A of the manifold body 11.

  As shown in FIG. 4, the openings 13 preferably further extend in the radial direction of the manifold body 11. Thereby, the stylet 20 can be firmly fixed to the manifold body 11.

  As shown in FIG. 5, the opening 13 preferably extends along the circumferential direction of the manifold body 11. In that case, the opening 13 may be provided in a part of the circumferential direction of the manifold body 11 or may be provided over the entire circumferential direction. As the opening 13 extends along the circumferential direction of the manifold body 11 in this manner, the folded section 21 can be easily inserted into the opening 13.

  The stylet 20 is preferably removable from the manifold body 11 but may be glued or welded to the manifold body 11.

  The proximal end 22 of the stylet 20 may be directed distally, proximally or radially outward of the manifold body 11 but positioned so as to face the manifold body 11 distally Is preferred. In that case, the proximal end 22 of the stylet 20 preferably has a flat surface. Since the proximal end face of the stylet 20 easily contacts the inner wall of the manifold body 11, the stylet 20 does not easily come off the manifold body 11.

  As shown in FIGS. 1 and 3, the proximal end of the stylet 20 may be curved to form a turnback section 21. Specifically, as shown in FIG. 1, it is preferable that the proximal end of the stylet 20 be folded in a U-shape. By forming the proximal end of the stylet 20 in a curved shape in this manner, it is possible to suppress partial stress concentration.

  As shown in FIG. 6, the proximal end of the stylet 20 may be bent to form a folded section 21. Thus, the stylet 20 and the manifold body 11 can be firmly fixed by forming the stylet 20 in a bent shape.

  A turnaround section 21 may be provided more distal than the proximal end 22 of the stylet 20, as shown in FIG. For example, the stylet 20 may have a section (auxiliary fixed section 24) extending in a direction different from the perspective direction on the proximal side of the proximal end of the turnback section 21. When the stylet 20 has the auxiliary fixed section 24, although not shown, the opening 13 of the manifold body 11 is adjacent to the first section extending along the perspective direction and adjacent to the first section. It is preferable to have a second section extending in a direction different from the direction. The folded section 21 of the stylet 20 can be disposed in the first section of the opening 13, and the auxiliary fixed section 24 of the stylet 20 can be disposed in the second section of the opening 13. By providing the auxiliary fixing section 24 of the stylet 20 and the second section of the opening 13 as described above, the stylet 20 is further easily fixed by the opening 13 of the manifold body 11, and the stylet 20 can be prevented from being displaced.

  In the auxiliary fixed section 24, the stylet 20 preferably extends in the radial or circumferential direction of the manifold body 11. For example, FIG. 7 shows an example in which a radially extending auxiliary fixation section 24 is provided on the proximal side of the proximal end of the turnback section 21.

  As shown in FIG. 1, in the catheter 1 or the manifold 10, a lid member 32 is preferably disposed at the proximal end of the manifold body 11. A lid member 32 is provided to close the proximal end of the main lumen 12A of the manifold body 11. Also, the stylet 20 and the elastic member 34 can be pressed in the distal direction by the lid member 32. Preferably, the proximal end of the manifold body 11 and the lid member 32 are engaged. For example, a screw thread 16 may be formed on the outer peripheral surface of the proximal end of the manifold body 11, and a groove 33 may be formed in the lid member 32 to engage with the screw thread 16.

  The lid member 32 preferably has a through hole penetrating in the perspective direction. Another member such as a guide wire can be introduced into the tubular member 5 through the through hole.

  The lid member 32 can be made of the same material as the manifold body 11.

  An elastic member 34 is preferably provided at the proximal end of the main lumen 12A of the manifold body 11. Thereby, the stylet 20 can be supplementary fixed by the elastic member 34. The elastic member 34 preferably has a through hole penetrating in the perspective direction. A guide wire can be inserted through the through hole. Although not shown, a groove may be provided on the distal end surface of the elastic member 34. Since the stylet 20 can be disposed in this groove, the manifold body 11 and the stylet 20 are more firmly fixed. The elastic member 34 can be made of silicone rubber, polyamide elastomer or the like.

  As shown in FIG. 1, it is preferable that the folded back section 21 of the stylet 20 be in contact with the elastic member 34. As a result, since the folded back section 21 of the stylet 20 is pressed by the elastic member 34, the stylet 20 can be fixed without blocking the movement of other members or the like inserted into the lumen 12.

  It is preferable that the distal end side of the stylet 20 (more preferably, the facing section 23 facing the turning section 21) is in contact with the distal end of the elastic member 34. Since the distal side of the stylet 20 is more easily displaced radially outward than the folded back area 21 of the stylet 20 by holding the elastic member 34 on the distal side of the folded back area 21 of the stylet 20, the insertion into the lumen 12 The movement of the other members etc. is less likely to be impeded.

  A seal member 35 may be provided between the lid member 32 and the elastic member 34 in the direction of the manifold main body 11. Thereby, the sealing property of the lid member 32 and the elastic member 34 can be enhanced. As the seal member 35, an O-ring can be mentioned.

1: Catheter 5: Tubular member 10: Manifold 11: Manifold body 12: Lumen 12A: Main lumen, 12B: Secondary lumen 13: Opening 14: Small diameter part 15: Convex part 16: Thread 20: Stylet 21 A: return area 22: proximal end 23: opposite area 24: auxiliary fixed area 30: connection member 31: protection member 32: lid member 33: groove 34: elastic member 35: seal member

Claims (8)

A tubular member,
A manifold body having a lumen extending in a perspective direction and connected to the proximal end of the tubular member;
A catheter having a stylet extending in the perspective direction, the stylet being insertable into the lumen;
A catheter characterized in that the proximal end of the stylet has a section that is folded back towards the distal side.   The catheter according to claim 1, wherein an opening into which the proximal end of the stylet can be inserted is formed on the proximal side of the manifold body and radially outward of the central axis of the lumen.   The catheter according to claim 2, wherein the opening extends along the perspective direction.   The catheter according to claim 3, wherein the opening further extends along a radial direction of the manifold body.   The manifold according to claim 2, wherein the opening extends along a circumferential direction of the manifold body.   The catheter according to any one of the preceding claims, wherein the proximal end of the stylet is arranged to face the distal side of the manifold body.   The catheter according to any one of claims 1 to 6, wherein the proximal end of the stylet is folded back in a U-shape. A manifold for use with a stylet extending in a perspective direction through which a tubular member can be inserted and connected to the proximal end of said tubular member, wherein
The manifold body extending in the perspective direction and having a lumen;
A manifold characterized in that an opening into which the proximal end of the stylet can be inserted is formed on the proximal side of the manifold body and radially outward of the central axis of the lumen.

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