JP2001046505A - Catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide catheter with a high safety that prevents its slip-off from inserted region, excels in operability and keeps tissues from damages and others. SOLUTION: The catheter 1 consists of a catheter body 2 composed of a flexible tube and a hub 8 attached to a catheter body 2 and the base end of the catheter body 2. The catheter body 2 has a linear part 3 and a spiral part 4, and a lumen 5 has been formed in their interior. The spiral part 4 has formed spiral shape, namely having the first loop 41 and the second loop 42, in the state without external force applied, whereas it forms a nearly straight line in the state that a core material has been inserted into the lumen 5 up to its tip end. And the spiral part 4 restores to its original shape when the core material is pulled out from the lumen 5. A side hole 6 communicating with the lumen 5 has been formed on inner circumferential side of the spiral of the spiral part 4.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a catheter used by inserting it into a lumen of a living body such as a bile duct.

[0002]

2. Description of the Related Art Conventionally, the shape of the distal end portion of a catheter for bile duct drainage (for suction) is mainly linear.

However, when such a catheter is placed in the bile duct and an external force acts on the catheter due to hepatic respiratory movement or postural change of the patient and the catheter is pulled in the proximal direction, the conventional catheter cannot be moved from the bile duct. Deviations are likely to occur and the catheter must be reinserted. In most cases, it takes time between the occurrence of such a deviation and its discovery, which may worsen the patient's condition. In addition, peritonitis and the like may be caused by such deviation of the catheter.

Therefore, as shown in FIG. 10, a pigtail-shaped catheter 50 whose tip is curved in an arc shape has been developed. This catheter has a hollow tubular catheter body 51 having flexibility, and the distal end has a pigtail shape (the pigtail shape portion 5).
2) When a core material (not shown) such as a guide wire is inserted into the catheter main body 51, the pigtail shape portion 52 extends substantially linearly due to its rigidity, and when the core material is removed, the pigtail shape is restored to the pigtail shape again. .

However, such a catheter 50
However, since the pigtail-shaped portion 52 is rich in flexibility, the radius of curvature of the pigtail-shaped portion 52 is easily increased when the conventional distal end is pulled in the proximal direction, similarly to the linear catheter described above, Deviation from the bile duct may occur.

[0006] Further, the catheter 50 having the pigtail shape at the distal end requires a space in the bile duct larger than the diameter of the pigtail shape portion 52 when the shape is restored. Restoration to the pigtail shape may become impossible or difficult, and the distal end 53 of the catheter body 51 may remain stuck in the bile duct wall. In such a case, it may cause cholangitis.

[0007] In addition, as shown in FIG.
The distal end 53 of the catheter body 51 is oriented in a direction different from the center line 54 (or an extension thereof) of the catheter main body 51 at the base end side of the pigtail-shaped portion 52, so that the operator confirms the indwelling state of the catheter 50 by the operator. When the contrast medium is injected and injected into the bile duct via 50 and viewed under X-ray fluoroscopy, the tip 53 of the catheter body 51 is inserted into the bile duct even though the tip of the catheter body 51 is kept in a correct posture. It appears to be pierced, and such an erroneous recognition may cause the operator to re-deploy the catheter (act that is originally unnecessary).

The distal end 53 of the catheter body 51 is
When the pigtail shape portion 52 is restored to the original shape, the direction gradually changes. When the restoration is completed, the tip 53 is oriented in a direction different from the center line 54. May contact or slide against the inner wall of the bile duct and damage the inner surface of the bile duct, so that inflammation from the tip of the catheter may occur.

[0009]

SUMMARY OF THE INVENTION An object of the present invention is to provide a catheter which is prevented from deviating from an insertion site, has excellent operability, prevents damage to tissue, and has high safety.

[0010]

This and other objects are achieved by the present invention which is defined below as (1) to (17).

(1) A catheter having a flexible tube-shaped catheter main body, wherein a spiral-shaped helical portion is formed on the distal end side of the catheter main body when no external force is applied to the catheter. The catheter, wherein the helical portion has a substantially linear shape when the core material is inserted into the main body up to the distal end.

(2) The catheter according to the above (1), wherein when the core material is removed from the catheter body, the helical portion returns to its original shape.

(3) The time from the removal of the core material to the restoration of the spiral shape portion to the original shape is 0.1 to 18 hours.
The catheter according to the above (2), which has a restoring speed of 0 second.

(4) The bending elastic modulus of the catheter body in the helical portion is 100 to 40000 kg / cm ^2.
The catheter according to the above (2) or (3), wherein

(5) After the core material is removed from the catheter body, there is provided a restoration assisting means for assisting restoration of the helical portion to the original shape or assisting in maintaining the original shape. The catheter according to 1).

(6) The catheter according to the above (5), wherein the restoration assisting means includes a linear member for pulling the helical portion and a lock mechanism for fixing the linear member in a pulled state.

(7) The catheter according to the above (1), further comprising restoring means for restoring the helical portion to the original shape or fixing the original shape after removing the core material from the catheter body.

(8) The catheter according to the above (7), wherein the restoring means includes a linear member for pulling the helical portion, and a lock mechanism for fixing the linear member in a pulled state.

(9) The catheter according to the above (6) or (8), wherein the lock mechanism includes an elastic body for holding the linear body by compression, and an operating body for compressing the elastic body.

(10) In any one of the above (1) to (9), the center of the helix of the helical portion is substantially located on an extension of the catheter body on the proximal side from the helical portion. Catheter.

(11) In any one of the above (1) to (10), the distal end of the spiral-shaped portion projects in substantially the same direction as an extension of the catheter body on the proximal side from the spiral-shaped portion. Catheter.

(12) The spiral-shaped portion has a first loop and a second loop located on the tip side of the first loop, and the spiral radius of the second loop is equal to the first loop. The catheter according to any one of (1) to (11), wherein the catheter has a helical radius of the loop or less.

(13) The outer diameter of the catheter body is D
_1, when the maximum spiral radius of the spiral-shaped portion and the R _1, 1
The catheter according to any one of the above (1) to (12), which satisfies ≦ R ₁ / D ₁ ≦ 5.

(14) The above (1) to (13), wherein the spiral pitch in the spiral shaped portion is 1 to 30 mm.
The catheter according to any one of the above.

(15) At least 1
The catheter according to any one of the above (1) to (14), wherein one side hole is formed.

(16) The catheter according to (15), wherein the side hole is formed on an inner peripheral side of a spiral of the spiral-shaped portion.

(17) penetrating the tissue surrounding the body cavity,
The catheter according to any one of the above (1) to (16), wherein the spiral-shaped portion is used so as to be inserted into the body cavity.

[0028]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a catheter according to the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.

FIG. 1 is a plan view showing the overall shape of the catheter of the present invention (when the core material is not inserted), FIG. 2 is an enlarged view showing the configuration of the helical portion in the catheter of the present invention, and FIG.
FIG. 4 is a plan view showing the overall shape of the catheter of the present invention (when the core material is inserted), and FIG. 4 is an explanatory view showing the operation of inserting the catheter of the present invention into a bile duct. In this specification, the left side in FIGS. 1 to 3 is described as a “base end” and the right side is described as a “distal end”.

A catheter 1 according to the present invention shown in FIGS. 1 to 3 is a catheter for inserting a bile duct, which is attached to a catheter main body 2 formed of a flexible tube and attached to a proximal end of the catheter main body 2. (Fixed) hub 8.

A lumen 5 is formed substantially at the center of the catheter body 2 over the entire length of the catheter body 2. This lumen 5 is open to the proximal and distal ends of the catheter.

The outer diameter (average outer diameter) D _{1 of the} catheter body 2
Although is not particularly limited, it is usually preferably 10 mm or less in consideration of the reduction in the diameter of the catheter body 2.
It is more preferably about 2 to 8 mm, and 1.5 to 6 mm.
More preferably, it is about 5 mm.

The cross-sectional shape of the catheter body 2 is circular in this embodiment, but may be elliptical or the like.

As shown in FIG. 1, the catheter body 2 has a linear portion 3 extending almost linearly from the base end side, and a spirally deformed spiral portion 4.

The straight portion 3 is in a state where no external force is applied (bending,
In a natural state in which no external force such as torsion, tension, or compression is applied), and is substantially linear. The length of the straight portion 3 is not particularly limited, but is usually 100 to 1000 m.
m, more preferably about 150 to 500 mm. In the case of children and infants, the length may be shorter.

The helical portion 4 has a helical shape in a state where no external force is applied (a natural state in which no external force such as bending, twisting, pulling or compression is applied). In this case, the spiral shape is preferably a continuously curved shape such as a circular shape or an elliptical shape, and the direction of rotation of the spiral may be either right-handed or left-handed. The number of rotations of the spiral is not particularly limited, but is preferably about 1 to 6 rotations, and more preferably about 1.5 to 4 rotations.

In the present embodiment, the spiral-shaped portion 4 has two loops of a first loop 41 and a second loop 42 from the base end side, and a distal projection 43 following the second loop 42. are doing. The first loop 41 and the second loop 42 have different helical radii (curvature radii). In addition,
In the following description, unless otherwise specified, the spiral-shaped portion 4 will be described as a shape in a state where no external force is applied.

By providing such a spiral-shaped portion 4, even if the catheter 1 is pulled in the proximal direction in a state where the catheter 1 penetrates the wall of the bile duct and is inserted into the bile duct, the spiral-shaped portion is formed. 4 can be engaged with the wall of the bile duct to prevent deviation from the bile duct.

Center of the spiral of the spiral shaped part 4 (center of rotation)
Is preferably parallel to an extension 31 of the linear portion 3 (the catheter body 2 proximal to the helical portion 4), and is more preferably located substantially on the extension 31. Thereby, when the shape of the spiral part 4 is restored, it is possible to restore the shape of the bile duct in conformity with the shape of the bile duct, without applying extra pressure to the bile duct, and in particular, even when the diameter of the indwelling bile duct is small, the bile duct diameter can be reduced. Accordingly, the shape can be restored.

The first loop 41 located on the proximal side has a larger spiral radius (spiral turning radius) than the second loop 42. That is, the helix radius R ₁ of the first loop 41 and the helical radius R ₂ of the second loop 42, to satisfy R _1> R ₂ the relationship. This makes it possible to more reliably prevent the spiral-shaped portion 4 from deviating from the bile duct, and it is easy to manufacture (mold) the spiral-shaped portion 4.

In the present invention, the relationship between R ₁ and R ₂ is not limited to the above. For example, R ₁ may be equal to R ₂ .

The spiral radius R ₁ of the first loop 41 is the maximum spiral radius of the spiral-shaped portion 4. Here, the relationship between the outer diameter D ₁ of the catheter body 2 and the maximum spiral radius R ₁ preferably satisfies 1 ≦ R ₁ / D ₁ ≦ 5, and 1 ≦ R ₁ / D ₁ ≦ 5.
More preferably, R ₁ / D ₁ ≦ 4 is satisfied. If R ₁ / D ₁ is too small, it may not be possible to sufficiently prevent the spiral part 4 from deviating from the bile duct, and if R ₁ / D ₁ is too large, the spiral part 4 in the bile duct may not be prevented. Is difficult to restore to the original shape.

The preferred values of the helical radii R ₁ and R ₂ vary depending on the outer diameter D ₁ of the catheter body 2 and the like. Usually, the helical radius R ₁ is preferably about 3 to 25 mm, and 6 to 20 mm.
mm is more preferable, and the spiral radius R2 is ₂ to 22 m.
m is preferable, and about 3 to 18 mm is more preferable.

The pitch of the spiral in the spiral-shaped portion 4 (in the present embodiment, the interval between the first loop 41 and the second loop 42) is not particularly limited, but is usually preferably about 1 to 30 mm, and 1 to 30 mm. About 15 mm is more preferable. If the pitch of the spiral is too small, adjacent loops may contact or adhere to each other, and the flexibility of the entire spiral-shaped portion 4 may be reduced. If the pitch of the spiral is too large, deviation from the bile duct is sufficiently prevented. It may not be prevented.

The distal projecting portion 43 of the spiral-shaped portion 4 is formed from the spiral turning direction toward the distal direction of the catheter body 2, and is mainly used for preventing misperception during X-ray imaging and for preventing bile ducts. It plays a role in preventing inflammation. The tip protrusion 43 has a tapered shape whose outer diameter gradually decreases toward the tip. The distal end of the spiral-shaped portion 4 is open at the distal end of the lumen 5.

The tip projecting portion 43 preferably projects in a direction parallel to the extension 31 of the straight portion 3, and more preferably projects in substantially the same direction as the extension 31.
Thereby, when a contrast medium is injected through the catheter 1 under X-ray fluoroscopy, and a contrast is performed, it is possible to more reliably prevent the position and posture (projection direction) of the distal end protrusion 43 from being erroneously recognized. As a result, inflammation originating from the catheter tip in the bile duct can be more reliably prevented.

The length of the projecting portion 43 may be such that the function can be sufficiently exhibited.
mm, preferably about 5 to 10 mm.

In such a catheter 1, a core member 7 such as a guide wire or a stylet can be inserted into the lumen 5 from the hub 8 on the proximal end side. When the core 7 is a guide wire, it may be inserted from the tip of the catheter 1 in some cases.

As shown in FIG. 3, when the core 7 is inserted into the lumen 5 of the catheter main body 2 to the distal end, the spiral-shaped portion 4 has a substantially linear shape. The core material 7 has a sufficiently large rigidity as compared with the catheter body 2. For example, various metal materials such as stainless steel and a superelastic alloy such as a Ti—Ni alloy, and various materials having a high rigidity are used. Examples thereof include those made of plastic resin and the like.

In order to make it easier and smoother to insert and remove the catheter body 2 into and out of the lumen 5, the outer surface of the core material 7 may be made of, for example, a silicone resin or various hydrophilic polymers having lubricity. (Lubricating layer) is preferably formed by coating to improve the sliding (reducing the sliding resistance).

When the core 7 is removed from the lumen 5 of the catheter body 2, the helical portion 4 is restored to the original shape shown in FIG. Thereby, after inserting the spiral-shaped part 4 into a bile duct as a substantially linear shape which is easy to penetrate and insert into a bile duct, the core material 7 is removed and the spiral-shaped spiral-shaped part 4 can be formed.

The restoration speed of the spiral-shaped portion 4 is not particularly limited, but the time from the removal of the core material 7 to the restoration of the spiral-shaped portion 4 to the original shape (restoration time) is 0.1 to 180.
It is preferably on the order of seconds, more preferably on the order of 0.5 to 5 seconds. If this time is too short, the impact at the time of restoration will be large, and if this time is too long, the operation of placing the catheter 1 will take a long time.

In order to make it possible to restore the shape of the spiral-shaped portion 4 as described above, the bending elastic modulus of the catheter body must be 1
It is preferable that the 00~40000kg / cm ² or so, more preferably to 150~3000kg / cm ² or so, still more preferably a 200~700kg / cm ² approximately.

The method for forming the helical shape of the helical portion 4 is not particularly limited. For example, a metal wire is inserted into the catheter body 2 and the metal wire is plastically deformed to a desired helical shape. Then, the catheter body 2 in this portion is heated by immersing it in an oven or warm water or the like, cooled (rapid cooling or slow cooling), and formed (memory shape). Further, the spiral portion of the catheter body 2 may be cured by applying a medicine, irradiating radiation, ultraviolet rays, or the like. Further, the catheter body 2 may be made of a shape memory resin, and the shape may be stored in the same manner.

The helical portion 4 of the catheter body 2 has at least one side hole 6 communicating with the lumen 5. In this embodiment, a plurality of side holes 6 are formed along the longitudinal direction of the catheter body 2. By providing such a side hole 6, a liquid (bile or the like) in a bile duct can be sucked through the side hole 6, and a drug solution can be injected through the side hole 6.

The position where the side hole 6 is formed in the spiral-shaped portion 4 is on the inner peripheral side of the spiral, that is, on the curved inner surface side of the first loop 41 and / or the second loop 42.
Thereby, the side hole 6 does not contact and close the inner wall surface of the bile duct, so that suction or injection of a drug solution or the like can be performed efficiently.

The shape of the side hole 6 is not limited to a circle as shown in the figure, but may be any other shape such as an ellipse, a long hole, a triangle, a square,
It may be a polygon such as a hexagon.

The number of side holes 6 to be formed is not particularly limited.
About 0.5 to 8 pieces are preferable for one loop of the spiral-shaped portion 4, and about 1 to 5 pieces are more preferable.

The opening area of one side hole 6 is not particularly limited, but is preferably about 0.3 to ³ mm ² .
About ⁵ to 2.5 mm ² is more preferable.

Examples of the constituent material of the catheter body 2 having such flexibility (flexibility) include polyolefins such as polyethylene, polypropylene and polybutadiene, polyvinyl chloride, polyurethane, ethylene-vinyl acetate copolymer, and polyethylene. Various resin materials such as terephthalate, polyester such as polybutylene terephthalate, polyamide, polyether polyamide, polyester polyamide, polyurethane, soft polyvinyl chloride, ABS resin, AS resin, fluorine resin such as polytetrafluoroethylene, and shape memory resin; , Styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene,
Examples include various thermoplastic elastomers such as fluororubbers and chlorinated polyethylenes, and combinations of two or more of these (polymer alloys, polymer blends, laminates, etc.).

In order to make the insertion and removal of the core 7 easier and smoother, the inner surface of the lumen 5 of the catheter body is made of, for example, a silicone resin or various hydrophilic materials having lubricity. A coating (lubricating layer) such as a polymer may be applied.

The catheter body 2 may be constituted by a single layer, or may be constituted by a laminate of two or more layers. Further, a reinforcing material may be provided in or between the layers. As the reinforcing material, for example, a reinforcing member formed of a linear or spiral (coiled) linear body,
One composed of a net-like body is exemplified.

The number of layers constituting the catheter body 2, the constituent materials of each layer, the presence or absence of a reinforcing material, and the like may be different along the longitudinal direction of the catheter body 2.

For example, in order to make the helical portion 4 of the catheter main body 2 and the distal end protruding portion 43 more flexible, for example, the helical portion 4 or the distal end protruding portion 43 is provided.
It is possible to reduce the number of layers, to use a more flexible material, and to dispose the reinforcing material only in the relevant portion, as compared with the other portions. Thereby, the tip protruding portion 43 and the like have more flexibility and contribute to improvement of safety.

For the same purpose, the helical portion 4 or the tip projecting portion 43 may be formed of another member (a different material having higher flexibility). Examples of materials (elastic materials) that can be used for this include natural rubber, isoprene rubber, butadiene rubber (polybutadiene), chloroprene rubber, silicone rubber, urethane rubber (polyurethane), fluorine rubber, and styrene-butadiene rubber. Examples include various rubber materials and various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene.

The insertion and placement of the catheter 1 in the body are performed while confirming its position under fluoroscopy. Therefore, an X-ray opaque material (X-ray contrast agent) can be blended into the constituent material of the catheter body 2 to enable X-ray contrast. As the X-ray opaque material, for example, barium sulfate, bismuth oxide, tungsten, or the like can be used.

The X-ray opaque material is not limited to being present over the entire length of the catheter body 2, but may be a part of the catheter body 2, for example, a part of the linear part 3, the helical part 4. May be present in all or a part of.

A hub 8 is mounted on the proximal end of the catheter body 2. The hub 8 has an inner cavity communicating with the lumen 5. At least the distal end portion of the lumen has an inner diameter substantially equal to the inner diameter of the lumen 5 and is continuous with the inner surface of the proximal end portion of the lumen 5 without any step.

The base end of the hub 8 can be connected to, for example, an extension tube for suction, a stopcock, a syringe, and other various connectors.

The core material 7 such as the guide wire and the stylet described above can be inserted from such a hub 8, and various liquids such as a contrast agent (X-ray contrast agent), a drug solution, and physiological saline can be inserted. Can be injected or withdrawn. Further, through the lumen of the lumen 5 and the hub 8, it is possible to suck and discharge the liquid existing in the body cavity, that is, bile in the bile duct in this embodiment.

FIG. 5 is a plan view showing the overall shape of another embodiment of the catheter of the present invention. Hereinafter, the catheter of this embodiment will be described, but the description will focus on differences from the catheter of the above-described embodiment, and description of similar items will be omitted.

In the catheter 1 shown in FIG. 5, when the core material 7 is inserted into the lumen 5 to the distal end, the helical portion 4 has a substantially linear shape. The original shape shown in FIG. 5 is not completely restored by the restoring force of the spiral-shaped portion 4 itself. Here, “not completely restored” means that the helical shape portion 4 has no restoring force at all and also restores up to an intermediate shape but does not restore the original helical shape, The shape is restored, but the restoration speed is slow (for example, the restoration time exceeds the upper limit value), and the shape is completely restored. However, this also includes cases where it cannot be fixed (especially cannot be fixed stably), and as it is, the deviation from the bile duct or the like cannot be sufficiently prevented.

Therefore, the catheter 1 is provided with restoration assisting means for assisting restoration or fixing (retaining the original shape) of the spiral shaped portion 4 to the original shape. When the spiral shape portion 4 has no restoring force or cannot maintain the original shape, the restoration assisting means restores or fixes the spiral shape portion 4 to the original shape. However, in the present embodiment, since these are structurally the same, the following description will be made using "restoration assisting means" as a representative.

The restoration assisting means includes a yarn (linear body) 22 for pulling the distal end side of the spiral-shaped portion 4 in the proximal direction, and a lock mechanism 10 for fixing the yarn 22 in a pulled state.

The yarn 22 is not particularly limited, but usually is preferably a non-woven, non-porous material (for example, a commercially available suture). Further, a wire may be used instead of the thread 22.

One end of the thread 22 is fixed (fixed) to the branch hub 9, and from this fixed portion, the thread 22 is connected to the linear portion 3 of the catheter body 2, the first loop 41 and the second loop 42. The second loop 42 and the first loop 4 are sequentially passed through the lumen 5, come out of the lumen 5 through a side hole 6 formed on the distal end side of the spiral-shaped portion 4, and are folded in the proximal direction.
1, the inner portion 1 sequentially enters the lumen 5 from the side hole 6 formed near the proximal end of the spiral-shaped portion 4, and extends in the lumen 5 of the linear portion 3 toward the proximal end. That is, in the lumen 5 of the linear portion 3, the yarn 22
Is reciprocating.

In such a configuration, by pulling the other end side of the yarn 22 (the portion projecting from the base end of the operating body 17) in the base direction, the front end protrusion 43 is pulled in the base direction and extended. The helical shape portion 4 that has been restored to its original shape or its shape is maintained.

A bifurcated bifurcated hub 9 is attached to the proximal end of the catheter body 2 in a T-shape (or Y-shape), and one bifurcated end 91 is connected to the hub 8. A lock mechanism 10 is provided at the other branch end 92 which plays a similar role. The other end of the thread 22 in the lumen 5 is guided into the branch end 92 of the branch hub 9, and the lock mechanism 1
0, it protrudes from the base end opening of the branch end 92.

FIGS. 6 to 9 show the lock mechanism 10 respectively.
FIG. 2 is a longitudinal sectional view showing a configuration and an operation state of FIG. Hereinafter, the configuration of the lock mechanism 10 will be described with reference to these drawings. 6 to 9, the right side is referred to as a “proximal end” and the left side is referred to as a “distal end”.

The lock mechanism 10 is attached to the cylinder 11 constituting the base end of the branch end 92, the valve element (elastic body) 15 housed in the cylinder 11, and the base end of the cylinder 11. And an operating tool 17 to be operated.

A male screw 12 is formed on the outer periphery of the base end of the cylindrical body 11. A projection 13 is formed on the inner periphery of the base end of the cylinder 11, and a disk-shaped engaging portion 14 having an opening at the center is formed on the inner periphery of the distal end of the cylinder 11.

The valve body 15 is a cylindrical member made of an elastic material, and is housed so that the tip surface thereof comes into contact with and engages with the engaging portion 14. Thereby, the valve body 15
Even if it receives the pressing force from the proximal direction, it does not move to the distal side beyond the engaging portion 14.

Examples of the constituent material of the valve body 15 include various rubber materials such as natural rubber, isoprene rubber, butadiene rubber (polybutadiene), chloroprene rubber, silicone rubber, urethane rubber (polyurethane), fluorine rubber, and styrene-butadiene rubber. And various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluororubber, and chlorinated polyethylene.

In the state where no external force acts, the valve body 15
A thread 22 is movably inserted into the lumen 16. In the illustrated configuration, the inner diameter of the lumen 16 is constant over the entire length of the valve body 15, but is not limited to this. Configuration that is decreasing (configuration with constriction)
It may be.

The operating body 17 is a member in which the inner cylinder 18 and the outer cylinder 19 are arranged concentrically. The inner cylinder 18 is a member that presses and deforms the valve body 15 in the distal direction, and a thread 22 is inserted into its inner cavity. The outer cylinder 19 is a member that functions as a grip for rotating the operation body 17. The inner cylinder 18 and the outer cylinder 19 are connected and integrated at their base ends. Then, the base end of the cylinder 11 is inserted between the inner cylinder 18 and the outer cylinder 19.

On the inner periphery of the distal end of the outer cylinder 19, the male screw 12
And a female screw 20 that is screwed into the screw. Also, inner cylinder 1
8 has a protrusion 2 which can be engaged with the protrusion 13.
1 is formed.

As shown in FIG. 6, when the operating body 17 is located at the most proximal side, the distal end surface of the inner cylinder 18 is
Since it is not in contact with 5, the lumen 16 of the valve body 15 is open, so that the thread 22 can move freely in its longitudinal direction.

At this time, since the convex portion 13 and the convex portion 21 are engaged with each other, the movement of the operating body 17 in the proximal direction is restricted, and the operating body 17 comes off the tubular body 11 and separates. Is prevented.

From this state, the operating body 17 is rotated clockwise with the other hand while the cylindrical body 11 is fixed by hand. Thereby, as shown in FIG. 7, the operating body 17 moves in the distal direction, and the distal end surface of the inner cylinder 18 presses the valve body 15. Valve body 1
Since the movement of the distal end 5 in the distal direction is restricted by the engaging portion 14, the pressing member 5 is compressed and shortened in length,
Accordingly, the diameter of the inner cavity 16 is reduced, and the inner cavity 16 comes into close contact with the outer peripheral surface of the yarn 22. Thereby, the thread 22 is slightly fixed, and the valve body 1
5 closes the cylinder 11 in a liquid-tight manner.

When the operation body 17 is further rotated clockwise from the state shown in FIG. 7, as shown in FIG. 8, the valve body 15 is further compressed, and the thread 22 is fixed with a stronger pressure. In this state, the yarn 22 cannot slide in its longitudinal direction.

As shown in FIG. 9, even when the thread 22 is not inserted, the operation body 17 is set at the same position as shown in FIG. Thereby, the cylindrical body 11 is liquid-tightly sealed. As a result, leakage of liquid from the branch end 92 and inflow of air are prevented, and suction and injection of a chemical solution or the like through the branch end 91 and the lumen 5 can be performed smoothly and reliably.

In the lock mechanism 10 having such a structure, in the state shown in FIG. 6 described above, the portion of the thread 22 protruding from the proximal opening of the operating body 17 is pulled, and the thread 22 is pulled in the proximal direction to form a spiral. The shape of the shape portion 4 is restored to the original shape (or the shape is fixed), and then the state shown in FIG. 7 is changed to the state shown in FIG. Thereby, the yarn 22 is fixed,
The movement is prohibited. That is, the state in which the spiral shape portion 4 is pulled by the yarn 22 is maintained, and the spiral shape portion 4 maintains the original shape.

When the core member 7 is inserted into the lumen 5 and the helical portion 4 is made linear, the locking mechanism 10 is used.
In the state shown in FIG.

In the present invention, the lock mechanism is not limited to the one described above, and may have any configuration as long as it can fix a linear body such as a thread. Wound thread (reel for winding thread)
Or, a linear body holding means such as a clip may be used.

Next, a method of using the catheter 1 of the present invention will be described for an example in which the core 7 is a guide wire.

First, the bile duct (tissue surrounding the body lumen) 1
The core material (guide wire) 7 is inserted into 00. At this time, the core 7 is inserted into the through-hole 101 formed in the bile duct 100.
Has passed.

Next, the proximal end of the core 7 located outside the body is inserted from the distal end of the lumen 5 of the catheter main body 2 to make the catheter main body 2 substantially linear. Then, the catheter body 2 is gradually advanced in the distal direction along the core material 7 and inserted into the bile duct 100 through the through hole 101 formed in the bile duct 100. At this time, since the spiral-shaped portion 4 has a substantially linear shape, the passage through the through-hole 101 is performed smoothly and easily.

The catheter main body 2 is appropriately rotated and advanced along the preceding core member 7 as described above.
When the distal end reaches a target site (a predetermined site in the bile duct 100), the core member 7 is pulled in the proximal direction, and is pulled out of the catheter body 2. Thereby, as shown in FIG.
The helical portion 4 restores its original shape in the bile duct 100.
In the case where the original shape is not completely restored by the restoring force of the spiral-shaped portion 4 itself, the spiral-shaped portion 4 is restored to the original shape by the restoration assisting means (or the restoring means) described above. Fix (hold) the shape. In any case, restoration or fixation of the shape of the spiral-shaped portion 4 is easily and reliably performed, and the distal projection 43 does not damage the inner wall surface of the bile duct 100.

As described above, the helical portion 4 is restored to the original shape or the shape is fixed, so that the catheter body 2 is stably placed in the bile duct 100, and the bile duct 1
Deviations from 00 are prevented.

Then, in this state, injection of a liquid such as a contrast agent or a drug solution through the lumen 5 of the catheter body 2 or
A liquid such as bile in the bile duct 100 can be sucked (drained). At this time, the injection and suction of the liquid are performed through the distal end opening of the catheter body 2 (the distal end protruding portion 43) and the respective side holes 6 formed in the helical portion 4,
Since the side hole 6 is formed on the inner peripheral side of the helix of the spiral-shaped portion 4, the side hole 6 does not contact and close the inner wall surface of the bile duct 100, and the injection and suction of the liquid is performed smoothly and reliably. Can be performed.

Further, even when the catheter main body 2 is pulled in the proximal direction due to, for example, hepatic respiratory movement, postural change, etc. while the catheter main body 2 is placed in the bile duct 100, as shown in FIG. In addition, since the helical portion 4 is formed, the helical portion 4 is caught on the bile duct wall around the through-hole 101, and the catheter body 2 is prevented from falling out of the bile duct 100.

As another example of use, when a stylet (pipe-shaped) is used as the core material 7, the core material (stylet) is used from the proximal end side of the catheter 1 (the hub 8 or the branch hub 9). 7 is inserted into the lumen 5 up to the vicinity of the distal end of the catheter 1, and the helical portion 4 is made substantially linear. Then, this is inserted into the bile duct 100 along the guide wire in the same manner as described above, and thereafter, the core material (stylet) 7 and the guide wire are removed from the catheter 1, and the spiral-shaped portion 4 is returned to its original state. Restore to a spiral shape.

When the catheter body 2 is pulled out of the bile duct, the core member 7 is inserted into the lumen 5 from the hub 8 or the branch hub 9 on the proximal side from the state shown in FIG. Into a substantially linear shape, and in this state, the catheter 1
Pull in the proximal direction. Thereby, the spiral-shaped part 4 passes through the through-hole 101, goes out of the bile duct 100, and is extracted.
At this time, since the spiral-shaped portion 4 has a substantially linear shape, the passage through the through-hole 101 is performed smoothly and easily.

The above operation is performed while confirming the position of the catheter body 2, particularly the position and posture of the spiral-shaped portion 4, under fluoroscopy. At this time, it is possible to avoid unnecessary re-insertion operation or the like based on the mis-recognition without misidentifying the position or posture of the spiral-shaped portion 4, particularly the direction of the distal end protruding portion 43, improving safety and improving patient safety. Contribute to reducing the burden.

The catheter of the present invention has been described based on the embodiments. However, it is needless to say that the present invention is not limited to these embodiments, and the configuration of each part may be replaced with any configuration capable of exhibiting the same function. be able to.

In the above, the case where the catheter of the present invention is used by inserting it into the bile duct has been described. However, the present invention is not limited to this. For example, gastrointestinal tract such as esophagus, stomach, intestine, etc.
The present invention can be applied to a catheter used for insertion and indwelling in various living body cavities such as trachea, lung, mediastinum, thoracic cavity, abdominal cavity, pelvic cavity, heart, gallbladder, liver, kidney, bladder, blood vessel, and the like. In particular,
Tissue surrounding such a body lumen (for example, in the case of a bile duct,
It is suitable for those used to penetrate the bile duct wall) and insert and detain it in the body lumen.

[0107]

As described above, according to the present invention, the insertion and placement of the catheter can be performed easily, reliably and safely, and the catheter can be prevented from falling off from the insertion site and can be stably placed. can do. As a result, examination and treatment via the catheter can be performed efficiently and accurately.

Further, the position and posture of the spiral portion can be easily grasped, and unnecessary reinsertion of the catheter due to misidentification can be avoided.

Further, since the position and posture of the helical portion, particularly the direction of the distal end protruding portion, are appropriate, the living tissue is not damaged, so that peritonitis, cholangitis, etc. derived from the distal end of the catheter can be prevented. .

As described above, the catheter of the present invention can greatly improve the safety as compared with the conventional catheter, reduce the labor and time required for the operation, and greatly reduce the burden on the patient. it can.

[Brief description of the drawings]

FIG. 1 is a plan view showing the overall shape of an embodiment of a catheter (when a core material is not inserted) of the present invention.

FIG. 2 is an enlarged view showing a configuration of a helical portion in the catheter of the present invention.

FIG. 3 is a plan view showing the overall shape of the embodiment of the catheter (when the core is inserted) of the present invention.

FIG. 4 is an explanatory view showing an operation of inserting the catheter of the present invention into a bile duct.

FIG. 5 is a plan view showing the overall shape of another embodiment of the catheter of the present invention.

6 is a longitudinal sectional view showing a configuration and an operating state of a lock mechanism in the catheter shown in FIG.

7 is a longitudinal sectional view showing a configuration and an operating state of a lock mechanism in the catheter shown in FIG.

8 is a longitudinal sectional view showing a configuration and an operating state of a lock mechanism in the catheter shown in FIG.

9 is a longitudinal sectional view showing a configuration and an operating state of a lock mechanism in the catheter shown in FIG.

FIG. 10 is a plan view showing the overall shape of a conventional catheter.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Catheter 2 Catheter main body 3 Linear part 31 Extension line 4 Helical part 41 First loop 42 Second loop 43 Tip projection part 5 Lumen 6 Side hole 7 Core material 8 Hub 9 Branch hub 91 Branch end 92 Branch end 10 Lock Mechanism 11 Cylindrical body 12 Male screw 13 Convex part 14 Engagement part 15 Valve body 16 Lumen 17 Operation body 18 Inner cylinder 19 Outer cylinder 20 Female screw 21 Convex part 22 Thread 50 Catheter (conventional example) 51 Catheter body 52 Pigtail shape part 53 Tip 54 Center line 100 Bile duct 101 Through hole

Claims (17)

[Claims] 1. A catheter having a flexible tube-shaped catheter main body, wherein a spiral-shaped helical portion is formed at a distal end side of the catheter main body when no external force is applied, The catheter according to claim 1, wherein the helical portion has a substantially linear shape when the core material is inserted into the inside of the catheter. 2. When the core material is removed from the catheter body, the helical portion returns to its original shape.
A catheter according to claim 1. 3. The catheter according to claim 2, wherein the catheter has a restoring speed such that the time from when the core material is removed to when the spiral-shaped portion is restored to the original shape is 0.1 to 180 seconds. 4. The catheter according to claim ² , wherein a bending elastic modulus of the catheter body in the spiral-shaped portion is 100 to 40000 kg / cm ² . 5. A restoration assisting means for assisting restoration of the helical portion to the original shape or assisting in maintaining the original shape after the core material is removed from the catheter body. A catheter according to claim 1. 6. The catheter according to claim 5, wherein the restoration assisting means includes a linear member for pulling the spiral-shaped portion, and a lock mechanism for fixing the linear member in a pulled state. 7. The catheter according to claim 1, further comprising restoring means for restoring the helical portion to the original shape or fixing the original shape after removing the core material from the catheter body. 8. The catheter according to claim 7, wherein the restoring means includes a linear member for pulling the helical portion, and a lock mechanism for fixing the linear member in a pulled state. 9. The catheter according to claim 6, wherein the lock mechanism includes an elastic body that sandwiches the linear body by compression, and an operation body that compresses the elastic body. 10. The catheter according to claim 1, wherein the center of the helix of the helical portion is substantially located on an extension of the catheter body proximal to the helical portion. 11. The catheter according to claim 1, wherein a distal end of the helical portion projects in a direction substantially the same as an extension of the catheter body on a proximal side from the helical portion. 12. The helical-shaped part includes a first loop,
And a second loop positioned on the distal end side of the first loop, wherein a spiral radius of the second loop is equal to or smaller than a spiral radius of the first loop. catheter. 13. When the outer diameter of the catheter body is D ₁ and the maximum helical radius of the helical portion is R ₁ , 1 ≦ R ₁
The catheter according to any one of claims 1 to 12, which satisfies / D ₁ ≤5. 14. The catheter according to claim 1, wherein a spiral pitch in the spiral shaped portion is 1 to 30 mm. 15. The catheter according to claim 1, wherein at least one side hole is formed in the spiral-shaped portion. 16. The catheter according to claim 15, wherein the side hole is formed on an inner peripheral side of a spiral of the spiral-shaped portion. 17. The catheter according to any one of claims 1 to 16, wherein the helical portion is used so as to penetrate a tissue surrounding the body lumen and to be inserted into the body lumen.