JP7108396B2 - catheter and manifold - Google Patents

Description

The present invention relates to a catheter having a stylet that increases proximal stiffness and a manifold used therein.

A linear member called a stylet is inserted into the catheter as shown in Patent Document 1 in order to increase the rigidity of the proximal side of the catheter and provide a stable shape.

As a method for fixing the stylet inside the catheter, for example, Patent Document 1 describes a catheter connector (manifold) capable of fixing the catheter to the proximal end of the catheter, and a catheter connector (manifold) capable of fitting with the catheter connector. A stylet connector is provided to which a stylet passing through the lumen can be secured. Specifically, the proximal end of the stylet is bent approximately 90 degrees and the tip is fixed to the stylet connector. Fixing the stylet in this manner prevents the stylet from falling out of the proximal side of the catheter.

Japanese Patent Application Laid-Open No. 2003-284780

However, even if the stylet is fixed by the method described in Patent Document 1, the stylet is displaced inside the tube during operation of the catheter, causing a member such as a guide wire to pass through the tubular member, or a drug solution. It was sometimes difficult to inject a contrast agent, etc. SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a catheter and a manifold in which the stylet is less likely to be displaced.

The catheter of the present invention, which has solved the above problems, includes a tubular member, a manifold body having a lumen extending in the distal and near directions, and a manifold body connected to the proximal end of the tubular member. , a distally extending stylet passable through the lumen, wherein the proximal end of the stylet is folded back distally. (hereinafter sometimes referred to as a "turning section"). In the catheter of the present invention, since the folded section of the stylet is easily engaged with the manifold body, the stylet is less likely to be displaced even when the catheter is manipulated, thereby preventing other members from being inserted into the tubular member, drug solutions, etc. can be smoothly injected.

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

Preferably, in the above catheter, the opening extends along the near-far direction.

Preferably, in the above catheter, the openings also extend along the radial direction of the manifold body.

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

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

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

The present invention also provides a manifold for use with a distally extending stylet insertable through the tubular member and connected to the proximal end of the tubular member. The manifold of the present invention has a distally extending manifold body with a lumen, and a stylet at a proximal portion of the manifold body and radially outwardly of the central axis of the lumen. The gist is that an opening is formed into which the proximal end can be inserted. According to the manifold of the present invention, by inserting the proximal end portion of the stylet into the opening of the manifold body, the manifold body and the stylet are easily engaged, so the stylet is less likely to be displaced even when the catheter is manipulated. As a result, it is possible to smoothly insert another member into the cylindrical member and to inject a liquid medicine or the like.

According to the catheter and manifold of the present invention, since the manifold body and the stylet are easily engaged with each other, the stylet is less likely to be displaced even when the catheter is operated. can be smoothly injected.

FIG. 2 shows a cross-sectional view (partial side view) showing the structure of the proximal side of the catheter according to the embodiment of the present invention; 2 represents a cross-sectional view of the catheter shown in FIG. 1 along line II-II; FIG. 2 depicts an enlarged side view of the proximal end of the stylet shown in FIG. 1; FIG. FIG. 2 shows a rear view showing a modification of the opening of the manifold shown in FIG. 1; FIG. 2 shows a rear view of another modification of the opening of the manifold shown in FIG. 1; Figure 4 shows a side view of a variation of the stylet shown in Figure 3; Figure 4 shows a side view of another variation of the stylet shown in Figure 3;

The catheter of the present invention includes a tubular member, a distally extending lumen, a manifold body connected to a proximal end of the tubular member, and a distally extending lumen. and a stylet that can be inserted into the lumen of the manifold body, wherein 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 section of the stylet is easily engaged with the manifold body, the stylet is less likely to be displaced even when the catheter is manipulated, thereby preventing other members from being inserted into the tubular member, drug solutions, etc. can be smoothly injected.

Also, the manifold of the present invention is for use with a distally extending stylet insertable through the tubular member and connected to the proximal end of the tubular member. An opening having an elongated manifold body with a lumen through which a proximal end of a stylet can be inserted in a proximal portion of the manifold body radially outwardly of the central axis of the lumen. is formed. According to the manifold of the present invention, by inserting the proximal end portion of the stylet into the opening of the manifold body, the manifold body and the stylet are easily engaged, so the stylet is less likely to be displaced even when the catheter is manipulated. As a result, it is possible to smoothly insert another member into the cylindrical member and to inject a liquid medicine or the like.

Hereinafter, the present invention will be described in more detail based on the following embodiments, but the present invention is not limited by the following embodiments, and can be modified appropriately within the scope of the above and later descriptions. It is of course possible to carry out in addition, and all of them are included in the technical scope of the present invention. In each drawing, for the sake of convenience, hatching, member numbers, etc. may be omitted. In such cases, the specification and other drawings shall be referred to. In addition, the dimensions of various members in the drawings may differ from the actual dimensions, since priority is given to helping to understand the features of the present invention.

In the present invention, catheters refer to medical catheters in general, including balloon catheters, microcatheters, penetrating catheters, and aspiration catheters. The catheter is suitably used for injecting a contrast medium in endoscopic retrograde cholangiopancreatography (ERCP), which is performed by imaging the bile duct or pancreatic duct with an endoscope. The proximal side of the catheter refers to the hand side of the user (operator) with respect to the extending direction of the catheter, and the distal side refers to the opposite direction to the proximal side (that is, the direction to the treatment target side). . Also, the direction from the proximal side to the distal side of the catheter is referred to as the distal or axial direction.

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

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

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

The tubular member 5 may be composed of a single layer, or may be composed of multiple layers. A part of the cylindrical member 5 in the axial direction or the circumferential direction may be composed of a single layer, and the other part may be composed of a plurality of layers.

The manifold 10 is connected to a syringe or the like for injecting a contrast medium or medicine into the cylindrical member 5 . The manifold 10 has a manifold body 11 . The manifold 10 may include a lid member 32, an elastic member 34, and a seal member 35, which will be described later. Manifold body 11 has a distally extending lumen 12 and is connected to the proximal end of tubular member 5 .

Manifold body 11 preferably has a plurality of lumens. As shown in FIG. 1, the lumen 12 of the manifold body 11 may have a main lumen 12A extending in the proximal direction and a secondary lumen 12B branching off from the main lumen 12A. In that case, the stylet 20 is preferably inserted through the main lumen 12A.

The axial direction of the secondary lumen 12B may be inclined, for example, in a range of 20 degrees or more and 80 degrees or less with respect to the axial direction of the main lumen 12A. In FIG. 1, the secondary lumen 12B is provided such that the axial direction of the secondary lumen 12B is inclined 60 degrees with respect to the axial direction of the primary lumen 12A.

The distally extending lumen (main lumen 12A in FIG. 1) of manifold body 11 preferably has a larger inner diameter at the proximal end than at the distal end. A resilient member 34 may be positioned at the proximal end of the main lumen 12A of the manifold body 11 to assist in securing the stylet 20 . The elastic member 34 will be described later.

As a material for forming the manifold main body 11, for example, synthetic resin such as ABS or polycarbonate, or plastic foam such as polyurethane foam can be used.

A tubular member 5 is preferably connected to the distal end of the manifold body 11 . The tubular member 5 and the manifold body 11 may be directly connected. In addition, as shown in FIG. 1, indirectly through 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. 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 portion of the tubular member 5 and the distal end portion of the manifold body 11 are disposed within a protective member 31 having a hollow portion. As a result, it is possible to prevent the tubular member 5 and the manifold body 11 from buckling due to sudden changes in the shape of the manifold 11 from the tubular member 5 . The protection member 31 is preferably provided with a gradient such that the outer diameter becomes smaller 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, the distal side of the manifold body 11 is preferably provided with a small diameter portion 14 having an outer diameter smaller than that of the proximal end. An annular projection 15 may be formed on the outer peripheral surface of the small-diameter portion 14 in order to improve fitting with the protective member 31 .

The stylet 20 is a linear member that can be inserted through 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 . At least a portion of the stylet 20 extends in the perspective direction. The stylet 20 may be a single wire, or multiple single wires that are bundled or twisted together. Alternatively, the stylet 20 may be formed by forming a wire into a coil shape.

Although not shown, the distal end of the stylet 20 is preferably positioned closer to the proximal side than the distal end of the tubular member 5, and closer to the proximal side than the axial center of the tubular member 5. It is more preferable to be located at 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) folded distally. Since the folded section 21 of the stylet 20 is easily engaged with the manifold body 11, the stylet 20 is less likely to be displaced even when the catheter 1 is operated. Injection can be done smoothly.

Folded section 21 is preferably provided in a portion including proximal end 22 of stylet 20 , but may be provided distally of proximal end 22 of stylet 20 .

The number of folded sections 21 is not particularly limited, and can be, for example, three or less. preferably.

The folded section 21 may be long enough to engage with the manifold body 11, and the length of the folded section 21 is, for example, 1% or less, 0.5% or less, or 0.3% of the total length of the stylet 20. can be:

As shown in FIG. 1 , the folded section 21 of the stylet 20 is preferably arranged radially outward from the central axis of the tubular member 5 , and the stylet 20 as a whole is positioned radially outward from the central axis of the tubular member 5 . are also arranged radially outward. As a result, the lumen 12 of the manifold body 11 and the lumen 6 of the tubular member 5 can be widened, so that the insertion of other members into the tubular member 5 and the injection of liquid medicine can be performed more smoothly. .

The stylet 20 preferably extends along the distal direction on the distal side of the folded section 21 . This makes it easier to insert the distal side of the folded section 21 of the stylet 20 into the main lumen 12A of the manifold body 11 extending along the distal and near directions. The stylet 20 is preferably straight. When the stylet 20 is straight, interference with a guide wire inserted into the tubular member can be reduced. The stylet 20 may be curved, such as wavy. For example, it may be helical in contact with the lumen 6 of the tubular member 5 .

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

In order to engage and secure the folded section 21 of the stylet 20 to the manifold body 11 , the manifold body 11 is preferably 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 formed in the proximal portion of the manifold body 11 and radially outward of the central axis C of the lumen 12 (main lumen 12A). It is more preferable to be formed. By inserting the folded section 21 of the stylet 20 into such an opening 13, the manifold body 11 and the stylet 20 can be engaged and fixed.

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

Although not shown, the opening 13 may be formed through the manifold body 11 . In that case, the opening 13 communicates with the outside of the manifold body 11 . However, when a liquid such as a drug solution flows into the lumen 6 of the tubular member 5 through the main lumen 12A of the manifold body 11, the opening 13 is formed on the inner wall of the manifold body 11 in order to prevent the liquid from leaking out from the opening 13. is preferably provided in

As shown in FIG. 1, the opening 13 preferably extends along the perspective direction. A part of the opening 13 may extend along the perspective direction, or the entire opening 13 may extend along the perspective direction. This makes it easier to insert the folded section 21 of the stylet 20 through the opening 13 .

It is preferable that the length L1 of the opening 13 is shorter than the length L2 of the folded 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 arranged to protrude from the opening 13, so that the stylet 20 can be easily arranged and removed.

Although not shown, the length L1 of the opening 13 may be longer than the length L2 of the folded 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 arranged further distally than the proximal end of the opening 13 , so the stylet 20 is less likely to slip out of the opening 13 .

As shown in FIG. 1 , the opening 13 of the manifold body 11 is preferably formed along the shape of the folded section 21 of the stylet 20 . This makes it easier to fix the stylet 20 to the manifold body 11, and prevents the stylet 20 from being displaced.

As shown in FIGS. 1 and 3 , a section (facing section 23 ) facing the folded section 21 of the stylet 20 in the perspective direction of the manifold body 11 forms the main lumen 12A of the manifold body 11 . preferably in contact with the inner wall. By bringing a portion of the stylet 20 into contact with the inner wall of the manifold body 11 in this manner, the stylet 20 is more likely to be arranged radially outward of the central axis C of the main lumen 12A of the manifold body 11 .

Preferably, the openings 13 also extend along the radial direction of the manifold body 11, as shown in FIG. This allows the stylet 20 to be firmly fixed to the manifold body 11 .

As shown in FIG. 5, the openings 13 preferably extend along the circumferential direction of the manifold body 11 . In that case, the opening 13 may be provided in a part of the manifold body 11 in the circumferential direction, or may be provided over the entire circumferential direction. Since the opening 13 extends along the circumferential direction of the manifold body 11 in this way, it becomes easier to insert the folded section 21 into the opening 13 .

Stylet 20 is preferably removable from manifold body 11 , but may be adhered or welded to manifold body 11 .

The proximal end 22 of the stylet 20 is arranged to face distally of the manifold body 11 , although it may face distally, proximally, or radially outwardly of the manifold body 11 . preferably. In that case, proximal end 22 of stylet 20 preferably has a flat surface. Since the proximal end surface of the stylet 20 easily contacts the inner wall of the manifold body 11 , the stylet 20 is less likely to come off from the manifold body 11 .

The proximal end of stylet 20 may be curved to form a folded section 21 as shown in FIGS. Specifically, as shown in FIG. 1, the proximal end of stylet 20 is preferably folded back into a U-shape. By forming the proximal end portion of the stylet 20 into a curved shape in this way, it is possible to suppress the stress from being concentrated locally.

The proximal end of the stylet 20 may be folded to form a folded section 21 as shown in FIG. The stylet 20 and the manifold body 11 can also be firmly fixed by forming the stylet 20 in such a bent shape.

A folded section 21 may be provided distal to the proximal end 22 of the stylet 20 as shown in FIG. For example, the stylet 20 may have a section (auxiliary fixing section 24 ) that extends in a direction different from the perspective direction proximally of the proximal end of the folded section 21 . When the stylet 20 has the auxiliary fixing section 24, although not shown, the opening 13 of the manifold body 11 has a first section extending along the perspective direction and a first section adjacent to the first section. It is preferred to have the second section extending in a direction different from the direction. A folding section 21 of the stylet 20 can be arranged in the first section of the opening 13 and an auxiliary fixing section 24 of the stylet 20 can be arranged 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 in this manner, the stylet 20 can be more easily fixed by the opening 13 of the manifold body 11, and the stylet 20 can be prevented from being displaced.

The stylet 20 preferably extends radially or circumferentially of the manifold body 11 in the auxiliary fixing section 24 . For example, FIG. 7 shows an example in which a radially extending auxiliary fixing section 24 is provided on the proximal side of the proximal end of the folded section 21 .

As shown in FIG. 1, in the catheter 1 or the manifold 10, it is preferable that a lid member 32 is arranged at the proximal end portion of the manifold body 11. As shown in FIG. A lid member 32 is provided to close the proximal end of the main lumen 12A of the manifold body 11 . Lid member 32 may also hold down stylet 20 and elastic member 34 distally. Preferably, the proximal end of manifold body 11 and lid member 32 are engaged. For example, a thread 16 is formed on the outer peripheral surface of the proximal end portion of the manifold body 11 , and a groove 33 that engages with the thread 16 is formed in the cover member 32 .

It is preferable that the lid member 32 has a through-hole penetrating in the distance direction. Other members such as a guide wire can be introduced into the cylindrical member 5 through the through hole.

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

A resilient member 34 is preferably provided at the proximal end of the main lumen 12A of the manifold body 11 . As a result, the stylet 20 can be additionally fixed by the elastic member 34 . It is preferable that the elastic member 34 has a through-hole penetrating in the far-near direction. A guide wire can be inserted through the through hole. Although not shown, the distal end surface of the elastic member 34 may be grooved. Since the stylet 20 can be arranged in this groove, the manifold body 11 and the stylet 20 are fixed more firmly. The elastic member 34 can be made of silicone rubber, polyamide elastomer, or the like.

Preferably, the folded section 21 of the stylet 20 is in contact with the elastic member 34, as shown in FIG. As a result, the folded section 21 of the stylet 20 is pressed by the elastic member 34 , so that the stylet 20 can be fixed without impeding movement of other members inserted into the lumen 12 .

The distal side of the folded section 21 of the stylet 20 (more preferably, the facing section 23 facing the folded section 21 ) is preferably in contact with the distal end of the elastic member 34 . Since the elastic member 34 presses the distal side of the folded section 21 of the stylet 20, the distal side of the folded section 21 of the stylet 20 is easily displaced radially outward. It becomes more difficult to hinder the movement of other members or the like to be carried out.

A seal member 35 may be provided between the lid member 32 and the elastic member 34 in the far-near direction of the manifold body 11 . Thereby, the sealing performance between the lid member 32 and the elastic member 34 can be improved. An O-ring can be used as the sealing member 35 .

1: Catheter 5: Tubular member 10: Manifold 11: Manifold body 12: Lumen 12A: Main lumen, 12B: Sub lumen 13: Opening 14: Small diameter portion 15: Convex portion 16: Thread 20: Stylet 21 : Folding section 22: Proximal end 23: Opposing section 24: Auxiliary fixing section 30: Connecting member 31: Protective member 32: Lid member 33: Groove 34: Elastic member 35: Sealing member

Claims (7)

a tubular member;
a manifold body having a distally extending lumen connected to the proximal end of the tubular member;
a stylet extending in the proximal and distal directions and insertable into the lumen;
a fixing member disposed in the lumen proximal to the stylet and in contact with the stylet to fix the stylet from the proximal side;
A catheter in which a groove is formed in the proximal portion of the manifold body for receiving the proximal end of the stylet and extending along the radial direction of the manifold body. a tubular member;
a manifold body having a distally extending lumen connected to the proximal end of the tubular member;
a stylet extending in the proximal and distal directions and insertable into the lumen;
a fixing member disposed in the lumen proximal to the stylet and in contact with the stylet to fix the stylet from the proximal side;
In the proximal portion of the manifold body radially outwardly of the central axis of the lumen is a groove capable of receiving the proximal end of the stylet and extending along the circumference of the manifold body. Catheter being formed . 3. A catheter according to claim 1 or 2, wherein the groove extends along the distal-to-near direction. The catheter of any one of claims 1-3, wherein the proximal end of the stylet has a section that is folded back distally. 5. The catheter of claim 4, wherein the proximal end of the stylet is positioned to face distally of the manifold body. 6. A catheter according to claim 4 or 5, wherein the proximal end of the stylet is folded back into a U-shape. A manifold for use with a distally extending stylet insertable through a tubular member and connected to a proximal end of the tubular member, comprising:
having a manifold body extending in the proximal and distal directions and having a lumen;
a groove into which a proximal end of a stylet can be inserted is formed in the proximal portion of the manifold body and radially outward from the central axis of the lumen;
The groove extends along at least one of a radial direction and a circumferential direction of the manifold body and extends distally and parallel to the bore in the radially outward portion of the groove. a manifold having a second lumen formed therein .

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