JPH08112245A - Catheter tube - Google Patents

Abstract

PURPOSE: To improve a fixing force between a plate coil and shaft tube in a catheter which has a tip part bending mechanism with the flat coil wound closely set within a lumen. CONSTITUTION: This catheter tube 1 is provided with a flat coil 5 wound closely which is set in arbitrary lumens 33 and 34 leaving one part 21 on the side of the tip of a tube body 2 as multi-lumen tube and traction wires 41 and 42 inserted through the flat plate 5 with one end thereof fixed at the tip 43 of the tube body 2 and the tip part 53 of the flat plate 5 and one part on the hand side are fixed in the lumen. A groove part 52 is formed on the outer circumference of the flat coil 5 positioned at least at the fixed part thereof and the tube body 2 is tightened from outside heating it to fix the tube 2 and the groove 52.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION The present invention relates to, for example, the heart, blood vessels,
Used by inserting into body cavities such as digestive tract, urethra, abdominal cavity,
A catheter tube for observing the insertion site and performing medical procedures,
In particular, it relates to a catheter tube that constitutes an endoscope.

[0002]

2. Description of the Related Art In a catheter tube used by being inserted into a body cavity, a bending mechanism (pivoting mechanism) is attached to the tip of the catheter tube in order to direct the tip of the catheter tube toward a target portion or to position it at the target portion. Mechanism) has been developed. In the field of endoscopes in particular, the bending mechanism is one of the important mechanisms in order to secure a desired visual field.

In recent years, as the diameter of an endoscope has been reduced, a bending mechanism having a structure not using node rings has been devised. In one of them, a densely wound flat plate coil is placed and fixed in the lumen in the non-curved portion of the multi-lumen tube,
There is a catheter tube having a structure in which a pulling wire is installed in the coil. In this case, the close-wound coil is fixed to the multi-lumen tube in the vicinity of the boundary between the curved portion and the non-curved portion and on the proximal side.

In this case, since the tightly wound coil is immovably fixed to the non-curved portion, the non-curved portion of the multi-lumen tube does not contract when the pulling wire is pulled in the proximal direction. Therefore, even if the pulling operation is performed, the non-curved portion is not curved.

[0005]

In such a catheter tube, the coil is fixed after the densely wound flat plate coil is inserted into an arbitrary lumen of the multi-lumen tube, which is one of the simplest fixing methods. Examples include tightening and fixing with a heat shrink tube. However, since the outer surface of the tightly wound flat plate coil is relatively flat,
It was difficult to obtain sufficient fixing strength even if the heat-shrinkable tube was tightened from the outside of the multi-lumen tube.

The present invention has been made in view of the above problems, and an object of the present invention is to provide a catheter tube having a distal end bending mechanism capable of reliably fixing a tightly wound coil in a lumen.

[0007]

The above objects are achieved by the present invention described in (1) to (10) below.

(1) A tube body, at least one lumen formed over substantially the entire length of the tube body, and a part or the entire length of the tube body, at least a part of which is attached to the tube body. A catheter tube having a tightly wound coil that is fixed, wherein a groove is formed on a side of the wire material that constitutes the closely wound coil, the side being in contact with the tube body.

(2) A tube body, at least one lumen formed over substantially the entire length of the tube body, and a part or the entire length of the tube body, at least a part of which is provided in the tube body. A catheter tube having a fixed tightly wound coil, wherein a groove is formed at least on the outer peripheral surface of the fixed portion of the closely wound coil.

(3) The tube body, at least one lumen formed over substantially the entire length of the tube body, and a part or the entire length of the tube body, at least a part of which is attached to the tube body. A catheter tube having a fixed tightly wound coil, wherein the tightly wound coil is formed of a flat plate material,
A catheter tube characterized in that a groove is formed between adjacent flat plates by causing a warp such that a central portion is recessed in a cross section of the flat plate material after coil forming.

(4) A catheter tube characterized in that the ratio D / t of the average value D of the outer diameter and the inner diameter of the tightly wound coil and the thickness t of the flat plate material is 2 to 5.

(5) The above-mentioned (1) to (1) characterized in that the closely wound coil is installed in the lumen.
The catheter tube according to any one of (4).

(6) The catheter tube according to any one of (1), (2), and (5), wherein the tightly wound coil is a flat coil.

(7) The catheter tube according to any one of the above (1) to (6), which has a tip bending mechanism.

(8) The above-mentioned (1), in which the tip end portion and the hand portion of the closely wound coil are adhered to the inner wall of the lumen.
The catheter tube according to any one of to (7).

(9) The catheter tube according to any one of the above (1) to (8), wherein the total clearance of the close-wound coil is within 10% of the total length of the close-wound coil.

(10) Any one of the above (1) to (9), wherein the inner diameter of the portion of the lumen where the tightly wound coil is arranged is 1.0 to 2.0 times the outer diameter of the tightly wound coil. The catheter tube according to.

[0018]

The catheter tube of the present invention comprises a tube body, a tightly wound coil, and a pulling wire.
The densely wound coil is installed in an arbitrary lumen of the tube body, leaving a part of the distal end side of the tube body, and the traction wire is inserted into the closely wound coil, and the tip of the traction wire is the tip of the tube body. It is fixed in the vicinity.

The close-wound coil is immovable with respect to the tube body because the tip end and a part of the proximal portion of the close-wound coil are fixed to the tube body.

As a method for fixing the close-wound coil, after inserting the close-wound coil into the tube main body, a heat-shrinkable tube is covered on the outside of the tube main body, and the portion to be fixed is heated to deform and tighten the tube main body. At this time, since the groove portion is formed on the outer peripheral surface of the close-wound coil, the inner wall of the lumen of the tube body fits into the groove portion, and the close-wound coil is securely fixed to the tube body.

In such a catheter tube,
If the pulling wire is pulled toward the hand side, only the tip portion of the catheter tube will be curved. Further, although the catheter tube receives a compressive force by pulling the pulling wire, since the close-wound coil is securely fixed as described above, the portion other than the tip bending portion does not bend or bend. .

In the present invention, the close-wound coil means that the total clearance between the coils is 0 of the total length of the close-wound coil.
It is within 10%.

[0023]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The catheter tube of the present invention will be described in detail below with reference to the preferred embodiments shown in the accompanying drawings.

FIG. 1 is an overall side view showing an embodiment in which the medical tube of the present invention is applied to a catheter tube which constitutes an endoscope (fiberscope).

FIG. 2 is a perspective view showing the structure of the distal end portion of the catheter tube shown in FIG.

FIG. 3 is a sectional view taken along the line I--I in FIG.
2 is a sectional view taken along line II-II in FIG. 2, and FIG. 5 is III-I in FIG.
A sectional view taken along line II, FIG. 6 is a sectional view taken along line IV-IV in FIG. 4,
FIG. 7 is a sectional view taken along line VV in FIG.

As shown in FIGS. 1 to 7, the catheter tube 1 is a multi-lumen tube body having four lumens of a first lumen 31, a second lumen 32, a third lumen 33 and a fourth lumen 34. The first lumen 31 and the second lumen 32 are open at the distal end portion of the catheter tube 1.
A densely wound flat plate coil 5 is housed in each of the third lumen 33 and the fourth lumen 34, and the flat plate coil 5 is fixed to the tube body 2 at a boundary portion 24 between the curved portion 21 and the intermediate portion 22 of the catheter tube 1. Has been done.
FIG. 8 shows a flat plate 51 that constitutes the flat coil 5. Thus, the groove 52 is formed on one side surface of the flat plate 51. As a method of fixing the flat plate coil 5, after inserting the flat plate coil 5 into the third lumen 33 and the fourth lumen 34, a heat-shrinkable tube (not shown) covering the fixing portion.
The tube body 2 is clamped and fixed from the outside by heating and shrinking. Since the tube body 2 is made of a thermoplastic material, the lumens 33, 3 can be formed by tightening the heat shrink tube while heating.
4 is narrowed, the inner wall surfaces 331 and 341 of the lumens 33 and 34 on the outer peripheral side of the tube body are deformed, and the flat coil 5
Into the groove 52.

As a method of forming such a flat plate coil 51, a round wire having an arbitrary outer diameter is rolled by a roller or the like into a flat plate, and then a roller having a protrusion for forming a groove is used. Roll it again. Further, rolling treatment may be performed again to make the thickness uniform. Further, in this embodiment, the groove 52 is provided at one place in the cross section of the flat plate 51, but a plurality of grooves may be formed as shown in FIG. Further, as shown in FIG. 10, a tightly wound coil may be formed by a flat plate having a groove on the edge of the flat plate. Such plate coils are made of, for example, stainless steel, tungsten,
It is composed of a metal material such as aluminum, platinum, brass, or a superelastic alloy, or a material such as Teflon (registered trademark), polyethylene, polyvinyl chloride, or polypropylene. The thickness of the flat plate forming the flat coil depends on the cross-sectional shape, the material, and the outer diameter, but in the case of stainless steel, the thickness is 10 μm.
~ 1 mm, more preferably 10 ~ 300 ~
There should be about m.

The pitch of the flat plate coil 5 is ideally in a so-called perfect contact state in which there is no gap between adjacent flat plates, but the total of the gaps is the total length of the tightly wound flat plate coil. Within the range of 0 to 10%, the coil does not bend at the non-curved portion (intermediate portion), and there is no practical problem. More preferably, it is about 0 to 3%.

It is also preferable to provide an adhesive layer in the groove of the flat plate coil so that it is more firmly fixed to the inner wall of the lumen. .

The tube body 2 includes pulling wires 41, 42.
When it is pulled toward the hand side, a material having flexibility such that the tip portion can be easily bent, such as polyurethane, polyvinyl chloride, polyamide, silicone rubber, polyethylene, ethylene-vinyl acetate copolymer, etc. It is made of a flexible material.

Further, since the catheter tube of the present invention is usually used in a state of being inserted and left in the body such as a blood vessel or a digestive tract, it can be observed while observing the existing position of the catheter tube under fluoroscopy. There is a high need for medical treatment. Therefore, it is preferable to impart X-ray contrast property to the catheter tube. Specifically, it is preferable that the material forming the tube body 2 contains an X-ray opaque substance. Examples of the X-ray opaque substance include metal compounds such as barium sulfate, bismuth oxide, and tungsten.

The tube body 2 is formed with various lumens having different uses and functions as described below.

The first lumen 31 accommodates the optical fiber bundle 8 as an observing instrument (fiberscope) for observing the inside of a body cavity such as a blood vessel or a tubular organ. The optical fiber bundle 8 can also be used for medical treatment such as irradiation of a laser beam to a blood vessel or an inner wall of a tubular organ.

The optical fiber bundle 8 is composed of a light transmitting fiber (light guide) 81 and a light receiving fiber (image guide) 82. These optical fibers are made of resin such as epoxy, acrylic, silicone rubber or the like. It is hardened into a bundle. The optical fiber 8 for light transmission
The optical fiber 1 and the light-receiving optical fiber 82 are each made of an optical fiber such as quartz, plastic, or multi-component glass.

A condensing rod lens 83 is attached to the tip of the optical fiber bundle 8, that is, near the opening of the tip of the first lumen 31.

Light emitted from a light source (not shown) on the proximal end side (right side in FIG. 1) of the operating tool 9 is guided by the light transmitting fiber 81, irradiated from the tip to the observation target portion, and the reflected light is reflected. Through the tip lens 83, the light receiving fiber 82
The image is transmitted through the light receiving fiber and guided to the image receiving unit (not shown) on the proximal side of the catheter tube.

The optical fiber bundle 8 includes the first lumen 3
However, it is preferable that the optical fiber bundle 8 is movable in the longitudinal direction of the first lumen 31 so that the tip of the optical fiber bundle 8 can be retracted from the tip opening of the first lumen 31. .

The second lumen 32 is opened to the distal end portion of the catheter tube and is used as an insertion channel for a guide wire, a medical treatment instrument or the like. For example, the second lumen 3
The optical fiber bundle can be housed in 2 to irradiate the blood vessel or the inner wall of the tubular organ with laser light, or a probe for calculus crushing can be stored to crush the calculus.

Further, the fluid can be injected into the blood vessel or the tubular organ through the tip end opening of the catheter tube, or the fluid can be sucked from the blood vessel. In particular,
This second lumen 32 has a catheter tube inserted,
Used to administer a drug solution into the indwelling blood vessel or tubular organ, or when observing the inside of the blood vessel or tubular organ with an endoscope, a transparent liquid for pushing out body fluid that hinders the field of vision (for example, It is also used as a flush channel for spraying physiological saline and glucose solution.

In the third and fourth lumens 33 and 34, the pulling wires 41 and 42 for bending the distal end portion of the catheter tube and the flat coil 5 are housed. The tip openings of the third and fourth lumens 33 and 34 are sealed with a filler 43, and the filler 43 allows the pulling wire 4 to pass through.
The tips of the tubes 1 and 42 are fixed to the tube body 2 at the tips of the tube body 2. In addition, the tow wire 4
The fixed positions of the tip ends of 1, 42 are the tip end 53 of the flat plate coil 5.
It is closer to the tip side of the tube body 2.

The fixed position of the tip ends of the pulling wires 41, 42 is an eccentric position from the central axis of the tube main body 2 in the cross section of the tube main body 2, whereby one of the pulling wires 41, 42 is fixed. When pulling to the proximal side,
As shown by the alternate long and short dash line in FIG. 1, the bending portion 21 can be bent toward the pulled wire side.

Therefore, the fixed position of the tip ends of the pulling wires 41, 42 is preferably a position sufficiently distant from the center of the cross section, for example, near the outer circumference in the cross section.

The pulling wires 41, 42 are preferably made of a material having a pulling strength that does not cause disconnection due to pulling operation. Specific examples thereof include thin metal wires such as stainless steel and superelastic alloy. Examples thereof include single wires and fiber bundles of polyamide, polyarylate, polyester, polyimide, polyethylene and the like, carbon fibers and the like. The diameter of the pulling wire depends on the material of the pulling wire, but in the case of a stainless wire, for example, 30 to 500 μm.
It is preferable that the thickness is about 50 to 300 μm.

By pulling the pulling wires 41, 42 in the proximal direction, the force for shrinking the side of the tube body 2 on which the pulling wires 41, 42 are arranged is in the proximal direction of the tube body 2. In addition, the tip portion of the tube body 2 bends, and the tip portion of the optical fiber bundle 8 in the first lumen 31 and the tip portion of the medical treatment instrument in the second lumen 32 bend accordingly. As a result, it is possible to observe the inner surface of the blood vessel or the tubular organ into which the catheter tube 1 has been inserted or perform medical treatment.

In the present invention, other lumens may be added in addition to the above first to fourth lumens. The lumen can be used by installing a balloon at the tip of a catheter tube and expanding and contracting the balloon.

As shown in FIG. 1, the catheter tube 1
The operating tool 9 connected to the proximal end side of the operating tool body 91 has an operating tool body 91, and the proximal end portion 23 of the tube body 2 is inserted from a manifold portion 92 formed at the tip of the operating tool body 91. . In addition, the grip portion 93 is provided on the proximal end side of the operation tool body 91.
The connector 94 for inserting the optical fiber bundle 8 of the endoscope into the lumen 31 is attached to the proximal end portion of the grip portion 93. Further, the grip portion 93 is formed with a branched portion 95 which is branched in an oblique direction, and a connector 96 for injecting, for example, a liquid into the lumen 32 is attached to an end portion of the branched portion 95. Connector 94 and lumen 31, Connector 96 and lumen 32
Are connected to each other in the operation tool main body 91 by conduits (not shown).

An operation dial 97 for pulling the wires 41 and 42 is rotatably supported between the manifold portion 92 of the operation tool body 91 and the grip portion 93. A take-up reel (not shown) is fixed to the rotary shaft of the operation dial 97 and rotates integrally with the operation dial 97.
The proximal ends of the wires 41 and 42 respectively have the lumen 3
It is exposed from the base ends of 3, 34 and passes through the inside of the operation tool main body 91,
The winding reels are wound in opposite directions. Accordingly, when the operation dial 97 is rotated clockwise in FIG. 1, the wire 42 is pulled and the wire 4 is pulled.
1 relaxes, the bending portion 21 bends upward in FIGS. 1 and 4, and when the operation dial 97 is rotated in the opposite direction to the above, the wire 41 is pulled, the wire 42 relaxes, and the bending portion 21 moves to the direction shown in FIGS. Although the catheter tube of the present invention has been described based on the illustrated embodiment so far as it is bent downward in FIG. 4, the present invention is not limited to this.

In the catheter tube of the present invention, the number and arrangement of each lumen are not limited to those shown in the drawings, and the number of lumens may be 1 to 3, for example. In addition to the illustrated lumens 31 to 34, another 1 or 2
The above lumens may be added.
For example, in the case of a balloon catheter provided with a balloon (not shown) that expands and contracts with a working fluid at the tip of the tube body 2, a lumen for supplying the working fluid into the balloon can be added.

Hereinafter, the catheter tube of the present invention will be described in more detail with reference to specific examples.

Example 1 A catheter tube having the structure shown in FIGS. 1 to 7 was manufactured. The conditions of this catheter tube are as follows.

<Tube body> Constituent material: Soft polyvinyl chloride outer diameter: 2.5 mm Total length: Approximately 50 cm Lumen number: 4 Lumens for storing operation wire and flat coil: 2 (inner diameter 0.5 mm) Optical fiber bundle storage Lumen: 1 (inner diameter 1.0 mm) Medical treatment, diagnostic tool storage lumen: 1 (inner diameter 1.0
mm) <Flat coil> Constituent material: Stainless steel Shape: One-thread single-layer close-wound.

Outer Diameter a: 0.7 mm Inner Diameter b: 0.3 mm Flat Plate Width w: 0.4 mm Groove Depth h: About 0.07 mm Groove Width w ′: About 0.1 mm <Operation Wire> Constituent Material: Poly Number of arylate twisted yarns: 2 Outer diameter: about 0.3 mm <Optical fiber bundle> Configuration: Image fiber (about 2000 quartz fibers with a diameter of about 3 μm) Light guide (25 quartz fibers with a diameter of 50 μm) Outer diameter: about 0. 9 mm (Example 2) A second example of the catheter tube of the present invention will be described. A catheter tube similar to that of Example 1 was manufactured except for the shape of the flat coil 5.

FIG. 11 shows a side view of the flat coil 6 used in the catheter tube of the second embodiment. The flat coil 6 is coil-formed by using a flat plate having a rectangular cross section, and then the front end portion 61 and a part on the proximal side (not shown) are cut to form a groove, and a post processing is performed to form a groove 62 on the outer peripheral surface thereof. Has been done. Examples of such post-processing include cutting with a tool, laser processing, compression processing, and thread cutting with a die.

The conditions of this flat plate coil are as follows.

<Plate coil> Outer diameter a: 0.7 mm Inner diameter b: 0.3 mm Flat plate width w: 0.4 mm Groove depth h: 0.05 mm Groove width w ': 0.1 mm Groove pitch P: 0. 3 mm By using the flat-plate coil 6 in which the groove 62 is formed only in the necessary portion as described above, it is possible to prevent the strength reduction of the portion other than the fixed portion.

(Embodiment 3) A third embodiment of the catheter tube of the present invention will be described. A catheter tube similar to that of Example 1 was manufactured except for the shape of the flat coil 5.

FIG. 12 shows a sectional view of the flat coil 7 used in the catheter tube of the third embodiment. The flat coil 7 is coil-formed by using a flat plate having a rectangular cross section, and the center diameter D of the coil is {center diameter = (outer diameter a +
Since the ratio D / t between the inner diameter b) / 2} and the thickness t of the flat plate is small, the flat plate after coil forming has a warp. By causing the warp in this way, the groove 71 is formed in the gap between the flat plates. The conditions of this flat plate coil are as follows.

<Plate coil> Outer diameter a: 0.6 mm Inner diameter b: 0.23 mm Flat plate width w: 0.4 mm Wall thickness t: 0.15 mm Center diameter D = 0.38 D / t = 2.53 D / t of such a flat coil is preferably 2 to 1
0, and more preferably 2.5 to 4.

With respect to the catheter tubes of Examples 1 to 3, when the dial 97 of the operating tool 9 was rotated to bend the bending portion 21, the bending operation was performed satisfactorily, and the lumen was crushed and blocked. No stenosis occurred.

Next, the fixing force of the flat coil was measured for each of the catheter tubes of Examples 1, 2 and 3 above. The measuring method was such that the load was applied when the coil was pushed by moving the coil while the catheter tube was fixed, and the strength was fixed.

As a result of the measurement, the fixing strength of each catheter tube of Examples 1 to 3 was 5.5 kgf and 5.0 kg.
It was f and 4.0 kgf, and it was confirmed that the tube body at the boundary between the curved tip portion and the intermediate portion of the catheter tube was securely fixed to the flat plate coil.

The application of the catheter tube of the present invention is not limited to the above-mentioned catheter tube for an endoscope, but may be applied to various catheter tubes such as an ablation catheter.

[0064]

As described above, according to the catheter tube of the present invention, the plate coil installed in the lumen is formed with the groove portion and tightened from the outside of the tube body, so that the plate coil and the tube body are securely fixed. It is possible to obtain sufficient fixing strength. Therefore, even if a compressive force is applied to the tube body when the distal end portion of the catheter tube is bent by pulling the pulling wire, the flat coil is difficult to move with respect to the tube body.

[Brief description of drawings]

FIG. 1 is an overall perspective view showing an embodiment when the catheter tube of the present invention is applied to an endoscope.

FIG. 2 is a perspective view showing a configuration of a distal end portion of the catheter tube shown in FIG.

FIG. 3 is a sectional view taken along line I-I in FIG.

FIG. 4 is a sectional view taken along line II-II in FIG.

5 is a sectional view taken along line III-III in FIG.

6 is a sectional view taken along line IV-IV in FIG.

7 is a cross-sectional view taken along line VV in FIG.

FIG. 8 is a diagram showing a flat plate in which a groove forming a flat plate coil is formed.

FIG. 9 is a diagram showing a flat plate in which a groove forming a flat plate coil is formed.

FIG. 10 is a diagram showing a flat plate in which a groove forming a flat plate coil is formed.

FIG. 11 is a side view of a flat plate coil showing a second embodiment of the present invention.

FIG. 12 is a sectional view of a flat plate coil showing a third embodiment of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Catheter tube 2 Tube main body 21 Curved part 22 Intermediate part (non-curved part) 23 Base end part 31-34 Lumen 331, 334 Inner wall surface 41, 42 Wire 43 Filler 5 Flat plate coil 51 Flat plate 52 Groove part 53 Tip part of flat plate coil 6 Flat Coil 61 Tip of Flat Coil 62 Groove 7 Flat Coil 71 Groove 8 Optical Fiber Bundle 81 Light Transmitting Fiber 82 Light Receiving Fiber 83 Rod Lens 9 Operation Tool 91 Operation Tool Main Body 92 Manifold Section 93 Grip Section 94 Connector 95 Branch Section 96 connector 97 operation dial

Claims (5)

[Claims] 1. A tube main body, at least one lumen formed over substantially the entire length of the tube main body, and a part or the entire length of the tube main body.
A catheter tube having a tightly wound coil, at least a portion of which is fixed to the tube body, wherein a groove portion is formed on a side of the wire material forming the closely wound coil, the side being in contact with the tube body. And catheter tube. 2. A tube body, at least one lumen formed over substantially the entire length of the tube body, and a part or the entire length of the tube body.
A catheter tube having a close-wound coil, at least a portion of which is fixed to the tube body, wherein a groove is formed on at least an outer peripheral surface of a portion of the close-wound coil fixed to the tube body. A catheter tube characterized by. 3. A tube body, at least one lumen formed over substantially the entire length of the tube body, and a part or the entire length of the tube body.
A catheter tube having a close-wound coil, at least a portion of which is fixed to the tube body, wherein the close-wound coil is made of a flat plate material, and a central portion is recessed in a cross section of the flat plate material after coil forming. Catheter tube characterized in that a groove is formed between adjacent flat plates by causing the warp of the catheter tube. 4. An average value D of the outer diameter and the inner diameter of the closely wound coil.
The catheter tube according to claim 3, wherein a ratio D / t between the flat plate material and the thickness t is 2 to 5. 5. The catheter tube according to claim 1, wherein the tightly wound coil is installed in the lumen.