JP3895755B2 - Medical tube - Google Patents

Description

  The present invention relates to a medical tube, and more particularly to a catheter tube constituting an endoscope.

  In a catheter tube used by being inserted into a body cavity, the distal end of the catheter tube is bent in a remote direction so that the tip of the catheter tube is directed toward the target site or positioned at the target site. A catheter tube having a mechanism (swing mechanism) has been developed. In particular, in a catheter tube constituting an endoscope, a bending mechanism at the distal end is one of important mechanisms for selecting a visual field of an observation site.

  Conventionally, as such an endoscope, a bending portion in which a plurality of node rings are sequentially connected to each other in a freely rotatable manner is provided at the distal end portion, and the distal end of each of the four wires fixed to the bending portion. A structure in which the bending portion is bent in four directions (up, down, left and right) by pulling a desired wire at the operation portion on the proximal end side has been used. However, in recent years, the diameter of an endoscope has been reduced. For this purpose, a bending mechanism that does not use a node ring has been developed.

  As one example, 1 or 2 of a multi-lumen catheter in which a plurality of lumens are formed along the longitudinal direction of a tube body composed of a non-curved portion to which a certain degree of rigidity is given and a curved portion located on the distal end side thereof. There is a catheter tube having a structure in which a wire for pulling a curved portion is inserted into one lumen. In this catheter tube, in order to reduce the diameter, the number of lumens for storing the wire is set to 2 or less. Therefore, the bending portion bends only in one or two directions by the pulling operation of the wire. Responds by rotating the entire catheter tube about its axis.

  In such a catheter tube with a rotation operation, it is necessary to provide torque transmission for rotation without impairing the flexibility of the catheter tube as much as possible. It has been proposed to embed a reinforcing member made of an aggregate of wire rods.

  However, the tube main body incorporating such a reinforcing member has the end surface of the reinforcing member exposed at the tube cutting surface at the distal end, and when the catheter tube is inserted into the body, the living tissue is damaged by the exposed wire end. There is a fear.

  A method of connecting a short tube having no reinforcing member to the tube cutting surface at the tip is also conceivable. However, when an external force acts on the connecting portion, the wire end of the reinforcing member is attached to the outer surface of the catheter tube. There is a risk of exposure, and there is a risk of damaging the living tissue with the exposed wire ends, as described above.

  An object of the present invention is to provide a medical tube that has moderate flexibility, is excellent in torque transmission and crush resistance, and does not expose the reinforcing material to the outer surface of the tube and has high safety. .

Such an object is achieved by the present inventions (1) to (8) below.
(1) A flexible tube main body in which at least one lumen is formed along the longitudinal direction, and at least a distal end portion of the tube main body so as to surround the lumen without being exposed on the surface of the tube main body. A medical tube having a tubular reinforcing material layer formed and a tip member that is joined to the tip of the tube body and is made of a material harder than the material of the tube body ,
The reinforcing material layer is composed of a braided body formed in a net shape by intersecting linear bodies,
A tapered portion whose outer diameter gradually decreases toward the distal end is formed on the outer peripheral surface of the tube main body, and a tapered portion that matches the tapered portion is formed on the inner peripheral surface of the distal end member. Having an annular portion formed, the two tapered portions are bonded or fused together, and the tip member is joined to the tip of the tube body,
The outer diameter of the distal end portion of the reinforcing material layer gradually decreases toward the distal end, and is smaller than the outer diameter of the proximal end portion of the reinforcing material layer,
The medical tube, wherein a distal end of the reinforcing material layer is located between a distal end and a proximal end of the distal end member and inside or inside the annular portion .

(2) The medical tube according to (1) , wherein the linear body that constitutes the reinforcing material layer is made of a metal material, a resin material, or carbon fiber.

(3) The metal material is stainless steel or a superelastic alloy, and the resin material is any one selected from the group consisting of polyamide, polyethylene, polypropylene, polyester, polyimide, and ABS resin (2 ) Medical tube as described in.

(4) the tube body has a plurality of lumens, in at least one lumen of which has an optical fiber bundle is accommodated, the above (1) to the wire is accommodated in the other lumen (3 ) A medical tube according to any one of the above.

(5) The tube body has a plurality of lumens, an optical fiber bundle is stored in at least one of the lumens, and a wire is stored in the other lumens,
The medical tube according to any one of (1) to (3) , wherein a distal end of the wire is embedded and fixed inside the distal end member so as not to be exposed at a distal end surface of the distal end member.

(6) The tube main body is located on the proximal side with respect to a bending portion that bends when the wire housed in the other lumen is pulled in the proximal direction, and is curved depending on the pulling of the wire. The medical tube according to the above (4) or (5) , in which a distal end portion of the reinforcing material layer is located at the curved portion.

(7) An anti-shrink member that can be bent but does not substantially contract in the longitudinal direction is housed in the other lumen of the portion that does not be bent by pulling the wire. The medical tube according to the above (6) , wherein the wire is inserted through the medical tube.

(8) wherein the anti-shrinkage member has its front end portion is fixed to said other lumen, and the distal end portion of the anti-shrinkage member, said lying proximal to the distal portion of the reinforcement layer The medical tube as described in (7) .

  According to the medical tube of the present invention, the installation of the reinforcing material layer made of a braided body ensures excellent torque transmission and lumen collapse resistance, and the end of the reinforcing material is placed on the outer surface of the tube body. Since it is prevented from being exposed, for example, when the tube is inserted into the body cavity, there is no risk of damaging the living tissue such as the inner wall surface, and the safety is high.

  In particular, in the present invention, since the reinforcing member is a braided body, a light weight and a high reinforcing effect can be obtained, the torque transmission performance is remarkably improved, and it is advantageous for reducing the diameter of the tube.

  Further, when the tip member is provided, in particular, a tip member having an annular portion is provided, and the tip of the reinforcing material layer is positioned on the tip side from the base end of the annular portion, and further inside the annular portion, or the annular portion. In the case of the configuration embedded in the inside, the effect of preventing the end of the reinforcing material from being exposed is more remarkably exhibited.

  Hereinafter, the medical tube of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.

  FIG. 1 is an overall side view showing an embodiment when the medical tube of the present invention is applied to a catheter tube constituting an endoscope (fiberscope), and FIG. 2 is a view of the distal end portion of the catheter tube shown in FIG. FIG. 3 is a sectional view taken along the line III-III in FIG. 2, FIG. 4 is a sectional view taken along the line IV-IV in FIG. 2, and FIG. FIG. 6 is a cross-sectional view taken along line VI-VI in FIG. 4, and FIG. 7 is a partially cutaway perspective view of the tube body of the catheter tube shown in FIG. In the following description, the right side in FIGS. 1 to 4 is referred to as a “base end”, and the left side is referred to as a “tip”.

  As shown in FIGS. 1 to 7, the catheter tube 1 of the present invention has a tube body 2. The tube body 2 is composed of a flexible polymer material such as soft polyvinyl chloride, polyethylene, polypropylene, polyurethane, polyamide, polytetrafluoroethylene, silicone rubber, and ethylene-vinyl acetate copolymer. In particular, in order to enable thermal deformation at the boundary portion 24 to be described later, it is preferably made of a thermoplastic resin such as polyvinyl chloride or thermoplastic polyurethane.

  Further, in order to make it possible to confirm the catheter tube 1 under X-ray fluoroscopy, it is preferable to impart X-ray contrast properties to the tube body 2, for example, in the constituent material of the tube body 2. Examples thereof include a method of blending a radiopaque material such as barium sulfate, bismuth oxide and tungsten, and a method of embedding or attaching a marker with such a radiopaque material to the surface.

  Moreover, in order to improve the slidability with respect to the body cavity to be inserted, the outer surface of the tube body 2 may be coated with a low friction material such as a hydrophilic polymer or a fluorine resin (for example, polytetrafluoroethylene). .

  A bending portion 21 that is bent by a wire operation described later is formed on the distal end side of the tube main body 2, and an operation tool that performs the bending operation of the bending portion 21 and other operations on the proximal end portion 23 of the tube main body 2. 9 is installed. Between the curved part 21 and the base end part 23 of the tube main body 2, it is comprised by the intermediate part 22, and the intermediate part 22 and the base end part 23 have a structure which is not curved by the wire pulling operation mentioned later. .

  As shown in FIGS. 2 to 4, a tip member 7 is joined to the tip of the tube body 2. The distal end member 7 has an annular portion 71 fitted to the distal end 26 of the tube main body 2 so as to cover the proximal end side thereof. A tapered portion 25 is formed on the outer peripheral surface of the distal end of the tube main body 2 so that the outer diameter thereof gradually decreases toward the distal end. On the other hand, the inner peripheral surface of the annular portion 71 matches the tapered portion 25. A tapered portion 72 is formed, and both the tapered portions 25 and 72 are bonded or fused together, and the distal end member 7 is joined and integrated at the distal end of the tube body 2. Thereby, the inner diameter of the base end 73 of the annular portion 71 is set larger than the outer diameter of the distal end 26 of the tube main body 2, and the distal end 26 of the tube main body 2 is the distal end of the annular portion 71 in the fitted state of the annular portion 71. Located near 74.

  In addition, on the outer surface of the curved portion 21, it is preferable that the boundary portion between the tube main body 2 and the tip member 7 constitutes a continuous surface having substantially no step. This makes it possible to smoothly and safely insert the catheter tube into the body (a tubular organ such as a blood vessel).

  Further, lumens 75 and 76 are formed through the distal end member 7, and the lumens 75 and 76 are formed in the tube body 2 in a state where the distal end member 7 is joined to the distal end of the tube body 2. It is connected to lumens 31 and 32 described later.

  Such a tip member 7 constitutes a part of the tube body 2 after being joined and integrated with the tip of the tube body 2.

  As the main constituent material of the tip member 7, in addition to those exemplified as the constituent material of the tube body 2, for example, polycarbonate, ABS resin, polystyrene, polyester, fluororesin, hard polyvinyl chloride, hard polyurethane, polyphenylene sulfide, poly Hard materials such as various hard resins such as ether ether ketone, various metals such as stainless steel, aluminum, titanium, tungsten, gold and platinum, various ceramics such as alumina, silica and hydroxyapatite can be used. When the tip member 7 is made of a material harder than the material of the tube body 2, there is an advantage that an end portion of the reinforcing material layer 5 described later is hardly exposed on the outer surface.

  The tip member 7 is fused or bonded to the tip of the tube body 2 according to its constituent material. For example, when the tip member 7 is made of the hard material, it is bonded with an adhesive.

  In addition, X-ray contrast can be imparted to the distal end member 7 by the same method as described above, whereby the distal end position of the catheter tube 1 can be grasped. Furthermore, the same low friction material as described above can be coated on the outer surface of the tip member 7.

  Four lumens 31, 32, 33 and 34 are formed in the tube body 2 over substantially the entire length in the longitudinal direction. As shown in FIGS. 2, 3, and 5, the lumens 31 and 32 are arranged so as to face each other through the central axis of the tube body 2 in the cross section, and the distal ends of both the lumens 31 and 32 are Each is open to the distal end surface of the tube body 2 via lumens 75 and 76 formed in the distal end member 7.

  The lumen 31 houses an optical fiber bundle 8 as an observation instrument for observing the inside of the body cavity into which the catheter tube 1 is inserted. The optical fiber bundle 8 can also be used for medical treatment such as irradiating a laser beam to the inner wall of a tubular organ (hereinafter, represented by a blood vessel) such as a blood vessel.

  As shown in FIG. 5, the optical fiber bundle 8 is composed of a light transmitting fiber (light guide) 81 and a light receiving fiber (image fiber) 82. These optical fibers are made of resin such as epoxy, acrylic, silicone rubber or the like. It is hardened and bundled.

  A lens 83 is attached to the tip of the optical fiber bundle 8, and this portion is located near the opening at the tip of the lumen 31. The optical fiber bundle 8 may be fixedly installed on the lumen 31 or may be slidably installed.

  Light emitted from a light source (not shown) on the proximal end side (right side in FIG. 1) of the operation tool 9 is transmitted through the light transmitting fiber 81, irradiated from the distal end to the observation portion, and the reflected light is reflected on the light receiving fiber. The image is taken in from the distal end of 82, and the image is transmitted through the fiber 82 and guided to an image receiving portion (not shown) on the proximal end side of the operation tool 9.

  The lumen 32 is open to the distal end of the tube body 2, and fluid can be injected into the blood vessel from the opening of the distal end, or the fluid can be sucked from the blood vessel. Specifically, the lumen 32 is used to administer a drug solution or the like into the blood vessel in which the catheter tube 1 is inserted and placed, or obstructs the field of view when observing the inside of the blood vessel with an endoscope. It is also used as a flush channel for injecting a transparent liquid (for example, physiological saline, glucose solution) for extruding blood.

  In addition to the above, the lumens 31 and 32 can also be used as insertion channels for guide wires, medical procedures, diagnostic tools, and the like. Examples of medical treatments and diagnostic tools include forceps, cytodiagnosis brushes, injection needles, high frequency, ultrasonic waves, electric hydraulic shock waves and the like (for crushing stones).

  Note that the inner surface of at least one of the lumens 31 and 32 can be formed of the above-described low friction material (for example, a coating layer of the low friction material is formed). In this case, the sliding resistance of the optical fiber bundle inserted into the lumen, medical treatment, diagnostic tool, etc. is reduced, and the insertion operation, movement, rotation and the like can be performed more smoothly.

  As shown in FIGS. 4 and 5, the lumens 33 and 34 are arranged so as to face each other through the central axis of the tube main body 2 and in a direction perpendicular to the lumens 31 and 32 in the cross section. The distal ends of the lumens 33 and 34 are respectively closed by the distal end member 7.

  As shown in FIGS. 4 and 6, anti-shrinkage members 6 each made of a flat coil in which a flat wire is spirally wound with almost no gap are accommodated in the lumens 33 and 34. The anti-shrink member 6 has flexibility and can be bent, but has an anti-shrink property that does not substantially shrink in the longitudinal direction thereof. The shrinkage of the main body 2 is prevented.

  The distal end portion of the anti-shrink member 6 is inserted to the vicinity of the boundary portion 24 between the curved portion 21 and the intermediate portion 22 of the tube main body 2, and is fixed at the boundary portion 24. That is, if the outer peripheral surface of the boundary portion 24 is heated and pressurized (clamped) in a state of being covered with, for example, a heat-shrinkable tube (not shown), the tube body material is melted or softened, and the lumens of the lumens 33 and 34 are narrowed. The inner wall surface of the lumen 33, 34 on the outer peripheral side of the tube body is deformed so as to protrude inward, and is pressed against and closely adhered to the outer peripheral surface of each anti-shrink member 6, and the friction force of each anti-shrink member 6 The tip is fixed to the lumens 33 and 34. Although not shown, the outer surface of the boundary portion 24 is slightly recessed due to the tightening of the heat-shrinkable tube.

  The fixing of the tip portion of the anti-shrink member 6 is not limited to the above method. For example, an adhesive (filler) or the like connects the inner surfaces of the lumens 33 and 34 and the outer peripheral surface of each anti-shrink member 6 at the boundary portion 24. For example, a method of bonding with each other, a method of fastening and fixing each anti-shrinkage member 6 by caulking with a caulking member, or the like may be employed.

  The anti-shrinkage member 6 is fixed to the lumens 33 and 34 at other locations, for example, at the base end portion 23 of the tube body 2. In addition, since the softness | flexibility of the anti-shrink member 6 will be impaired when there are too many fixed locations and fixed areas, it is preferable that the anti-shrink member 6 is fixed by about two places, a front-end | tip and a base end.

  Insertion holes 61 are formed in the central portions of the anti-shrink members 6 of the lumens 33 and 34, and wires 41 and 42 for pulling and bending the bending portion 21 are formed in both insertion holes 61. It is inserted. The wires 41 and 42 are exposed through the opening of each insertion hole 61 and are inserted into the lumens 33 and 34 in the bending portion 21, and the tips (heads) 43 and 44 of the wires 41 and 42 are embedded in the tip member 7. It has been fixed. In this case, the tips 43 and 44 of the wires 41 and 42 are arranged so as not to be exposed at the tip surface of the tip member 7, as in the reinforcing material layer 5 described later.

  The distal ends 43 and 44 of the wires 41 and 42 are respectively fixed at positions eccentric from the central axis of the tube body 2, and therefore when one of the wires 41 and 42 is pulled to the proximal end side, in FIG. As shown by the alternate long and short dash line, the bending portion 21 bends toward the pulled wire side. In this case, since the anti-shrinkage member 6 is fixed to the tube main body 2 at the boundary portion 24 and the base end portion 23, the middle portion 22 is hardly bent by pulling the wires 41 and 42, and the anti-shrinkage member 6 is Only the bending portion 21 that does not exist is reliably bent.

  Note that the wires 41 and 42 have strength and durability that do not cause breakage due to frequent traction operations, and are preferably less stretched, such as metals such as stainless steel and superelastic alloys. Examples thereof include single wires and fiber bundles made of wires, high-tensile resin fibers such as polyamide, polyethylene, polyarylate, and polyimide, and carbon fibers.

  In addition, the outer diameter of the wires 41 and 42 varies depending on the constituent materials and various conditions such as the cross-sectional shape, dimensions, and constituent materials of the tube body 2, but when the wires 41 and 42 are constituted by, for example, a polyarylate fiber bundle The outer diameter is preferably about 30 to 500 μm, particularly about 50 to 300 μm.

  Examples of the constituent material of the anti-shrink member 6 include metal materials such as stainless steel, carbon steel, copper, and copper alloys, and various resins such as polytetrafluoroethylene, polyethylene, polypropylene, polyvinyl chloride, and polyester.

  Further, the thickness of the anti-shrink member 6 varies depending on its constituent materials and various conditions such as the cross-sectional shape, dimensions, and constituent materials of the tube body 2, but the wire used for the flat plate coil is a stainless steel material having a rectangular cross section, for example. The thickness is preferably about 20 μm to 1 mm, particularly about 50 to 300 μm.

  In addition, the flat coil of the anti-shrink member 6 is not limited to a single-layer winding, and may be a plurality of layers or a plurality of windings.

  As shown in FIGS. 3 to 7, a tubular reinforcing material layer 5 is provided on the outer peripheral portion of the tube body 2 so as to surround the lumens 31 to 34 over almost the entire length of the tube body 2. In this case, the reinforcing material layer 5 is embedded so as not to be exposed on the outer surface of the tube body 2.

  The reinforcing material layer 5 in the present embodiment is composed of a braided body formed in a net shape by intersecting the linear bodies 51 (reinforcing materials) (see FIG. 7). Examples of the constituent material of the linear body 51 in the braided body include metal materials such as stainless steel and superelastic alloys, resin materials such as polyamide, polyethylene, polypropylene, polyester, polyimide, and ABS resin, and carbon fibers. It is done. As the linear body, a single wire of the material or a fiber bundle of the same or different material can be used.

  Thus, since the reinforcing material layer 5 is installed and reinforced by the braided body on the outer peripheral portion of the tube body 2, the torsional rigidity of the catheter tube 1 is high, and torque is transmitted during rotation on the proximal end portion 23 side. Excellent in properties. Further, when the tube main body 2 is curved, the lumens 31 to 34 are not easily blocked or constricted, and the tube main body 2 may be tightened by, for example, a backflow prevention valve provided on a catheter tube insertion sheath. Occlusion or stenosis due to collapse of the lumens 31 to 34 is prevented.

  The reinforcing material layer 5 may surround the outer periphery of each of the lumens 31 to 34 in a double or triple manner.

  The outer diameter of such a reinforcing material layer 5 is substantially constant, but the outer diameter gradually decreases (thinner diameter) toward the tip at the tip side (tip portion 52) from the taper portion 25. That is, the outer diameter of the distal end portion 52 of the reinforcing material layer 5 is set smaller than the outer diameter of the proximal end portion of the reinforcing material layer 5.

  Further, the distal end 53 of the reinforcing material layer 5 is located on the proximal side from the distal end surface of the distal end member 7. That is, the distal end 53 of the reinforcing material layer 5 is located on the distal end side with respect to the proximal end 73 of the annular portion 71 of the distal end member 7 and is located inside the annular portion 71.

  By adopting such a configuration, the linear body 51 of the reinforcing material layer 5 is exposed to the outer surface of the catheter tube 1 even when an external force is applied in the vicinity of the joint portion between the tube body 2 and the tip member 7. Therefore, when the catheter tube 1 is inserted into, for example, a blood vessel, the inner wall of the blood vessel or the like is not damaged and is safe.

  When the tip member 7 is made of a thermoplastic resin such as polyvinyl chloride or thermoplastic polyurethane, it is suitable for joining to the tube body 2 by fusion (thermal fusion, high frequency fusion, etc.). In the case of joining by such fusion, the tip 53 of the reinforcing material layer 5 can enter the inside of the tip member 7 as shown in FIG. By doing so, exposure of the linear body 51 to the outer surface of the catheter tube 1 is further reliably prevented.

  As shown in FIG. 1, the operating tool 9 connected to the proximal end side of the catheter tube 1 has an operating tool main body 91, and the tube main body 2 from the manifold portion 92 formed at the distal end of the operating tool main body 91. The base end portion 23 is inserted. A grip 93 is formed on the proximal end side of the operation tool main body 91, and a connector for inserting the optical fiber bundle 8 of the endoscope into the lumen 31 at the proximal end of the grip 93. 94 is installed. Further, a branching portion 95 branched in an oblique direction is formed in the gripping portion 93, and a connector 96 for injecting liquid, for example, into the lumen 32 is attached to the end of the branching portion 95. The connector 94 and the lumen 31, and the connector 96 and the lumen 32 are connected to each other within the operation tool main body 91 by a pipe line (not shown).

  An operation dial 97 that pulls and operates the wires 41 and 42 is rotatably supported between the manifold portion 92 and the grip portion 93 of the operation tool main body 91. A take-up reel (not shown) is fixed to the rotation shaft of the operation dial 97 and rotates integrally with the operation dial 97. The proximal ends of the wires 41 and 42 are exposed from the proximal ends of the lumens 33 and 34, pass through the operation tool main body 91, and are wound around the take-up reel in opposite directions. Thereby, for example, when the operation dial 97 is rotated clockwise in FIG. 1, the wire 42 is pulled, the wire 41 is relaxed, the bending portion 21 is bent upward in FIGS. 1 and 4, and the operation dial 97 is When rotating in the reverse direction, the wire 41 is pulled, the wire 42 is relaxed, and the bending portion 21 is bent downward in FIGS. 1 and 4.

  Although the medical tube of the present invention has been described based on the illustrated embodiment, the present invention is not limited to this.

  In the medical tube of the present invention, the number and arrangement of the lumens are not limited to those shown in the drawing, and for example, the number of lumens may be 1 to 3. Further, in addition to the illustrated lumens 31 to 34, one or more other lumens may be added. For example, when the balloon body is provided with a balloon (not shown) that is expanded and contracted by the working fluid at the distal end portion of the tube body 2, a lumen for supplying the working fluid into the balloon can be added.

Further, the reinforcing material layer 5 is not limited to the braided body having the configuration shown in FIG. Further, the shape of the tip member 7, particularly the shape of the joint portion with the tube body 2, can be arbitrary, and the tip member 7 may not be provided.
Hereinafter, the medical tube of the present invention will be described in more detail based on specific examples.

Example 1
A catheter tube having the structure shown in FIGS. 1 to 7 was produced by the following method.

  First, four lumen tubes formed on the outer surface of the core bar and having lumens to be the respective lumens 31 to 34 were prepared and bundled in a desired arrangement.

  Next, the braided body (reinforcing material layer 5) was wound around the bundle of each lumen tube, and the braided body was fixed by coating the same resin material as that of each lumen tube.

  Next, each lumen tube was covered and fixed with the same resin material so as to have a circular cross section, and a tube body 2 in which a braided body was embedded was obtained.

  Thus, the front-end | tip part of the tube main body 2 obtained was heated, and it pressed on the metal mold | die with a taper, and the taper part 25 was formed. At this time, as shown in FIG. 7, the distal end portion 52 of the reinforcing material layer 5 was also shaped into the same shape as the tapered portion 25.

  On the other hand, the annular member 71 having the taper portion 72 and the lumens 75 and 76 were formed on the inner surface of the material of the tip member by heating using a mold, and the tip member 7 was obtained. Further, the tip portions of the wires 41 and 42 were embedded in the tip member 7 during the heat processing.

  Next, the cored bar was extracted from the lumens 33 and 34, and a flat plate coil (anti-shrinkage member 6) was inserted into each of the lumens. A urethane-based adhesive is applied to the outer surface of the tip of the flat plate coil in advance and dried. A heat-shrinkable tube is wound around the boundary 24 in a state where the adhesive-applied portion is aligned with the boundary 24 and heated with hot air at 200 ° C. By contracting, the tube body 2 was deformed and the adhesive was softened, and each flat coil was adhered and fixed to the lumens 33 and 34.

  Next, in a state where the taper portion 25 of the tube body 2 and the taper portion 72 of the tip member 7 are in close contact so that the lumens 31 and 75 and the lumens 32 and 76 coincide with each other, these are heated by a mold, The tube main body 2 and the tip member 7 were joined and integrated by crimping and then cooling. At this time, the wires 41 and 42 whose tips are fixed to the tip member 7 were inserted into the lumens 33 and 34 from the tip side, respectively, and further inserted into the insertion holes 61 of both flat plate coils.

  Next, the cored bar was extracted from the lumens 31 and 32, and the optical fiber bundle 8 was inserted into the lumen 31 to obtain the catheter tube of the present invention.

Finally, the operation tool 9 having the configuration shown in FIG. 1 was attached to the proximal end portion of the catheter tube to configure the endoscope.
The various conditions of the endoscope catheter tube thus obtained are as follows.

<Tube body>
Constituent material: Thermoplastic polyurethane
(Contains tungsten filler, softening point: 95 ° C)
Outer diameter: 2.5mm
Outer diameter of the tip: 2.3mm
Taper angle of taper part: about 10 °
Full length: Approximately 50cm
Number of lumens: 4 Lumens for storing operation wires and flat coil: 2 (inner diameter 0.6mm)
Optical fiber bundle storage lumen: 1 (inner diameter 1.0mm)
Lumen for storing medical procedures and diagnostic tools: 1 (inner diameter 1.0mm)

<Tip member>
Constituent material: Thermoplastic polyurethane
(Contains tungsten filler, softening point: 130 ° C)
Outer diameter: 2.5mm
Annular base end inner diameter: 2.5mm
Annular part tip inner diameter: 2.1mm
Taper angle of taper part: about 10 °
Total length: about 5mm
Number of lumens: 4 Lumens for storing operation wires: 2 (tip closed, inner diameter 0.3 mm)
Optical fiber bundle storage lumen: 1 (inner diameter 1.0mm)
Lumen for storing medical procedures and diagnostic tools: 1 (inner diameter 1.0mm)

<Plate coil>
Constituent material: Stainless steel Structure: Single-layer, tightly wound Outer diameter: About 0.5mm
Inner diameter: about 0.35mm

<Wire>
Constituent material: Polyarylate twisted yarn Number: 2 Outer diameter: about 0.3mm

<Braided body>
Wire composition material: Stainless steel Number of wires: 16 each (8 right-handed, 8 left-handed)
Wire diameter: 0.05mm
Outer diameter: 2.4mm
Tip outer diameter: 2.2 mm
Tip position: 4mm from the tip of the tip member

<Optical fiber bundle>
Configuration: Image fiber (about 2000 quartz fibers with a diameter of about 3μm)
Light guide (25 quartz fibers with a diameter of about 50μm)
Outer diameter: about 0.9mm

(Example 2)
A catheter tube similar to Example 1 was prepared except that the tip member was made of thermoplastic polyurethane (containing tungsten filler, softening point: 95 ° C.) and the outer diameter of the braided body was 2.3 mm.

  In this catheter tube, as shown in FIG. 8, the tip 1 mm of the braided body (reinforcing material layer 5) was embedded in the tip member 7.

(Example 3)
A catheter tube similar to that in Example 1 was prepared except that the tip member was made of polycarbonate (containing tungsten filler) and was bonded to the tube body with an adhesive.

  For each of the catheter tubes of Examples 1 to 3, the operation dial 97 of the operation tool 9 was rotated and the bending portion 21 was bent. As a result, the bending operation was performed satisfactorily. Also did not occur.

  Next, the torque transmissibility in the rotation operation was examined for each of the catheter tubes of Examples 1-3. The measuring method was performed by rotating the proximal end side of the catheter tube in a straight line and measuring the rotational force generated at the distal end with a torque gauge.

  As a result of the measurement, the catheter tubes of Examples 1 to 3 all transmitted torque on the catheter tube proximal end side to the distal end portion by 70% or more, and had excellent torque transmission.

Next, for each of the catheter tubes of Examples 1 to 3, the presence or absence of the braided body when a predetermined stress was applied to the tube body was examined. In the measurement method, the tip of the catheter tube was pressed against the surface perpendicular to the axis of the tube with a load of 1 kgf / cm ² for 10 seconds.

  As a result of the measurement, exposure of the braided body or the linear body constituting the braided body or the linear body constituting the catheter tube of Examples 1 to 3, particularly Example 3 was not recognized at all.

  The use of the medical tube of the present invention is not limited to the above-described endoscope catheter tube, but includes, for example, various catheter tubes such as an ablation catheter and a cardiac output measurement catheter, and a trocar used for laparoscopic surgery or the like. It can be applied to pipes and other various pipes.

It is a whole side view which shows the Example at the time of applying the medical tube of this invention to the catheter tube which comprises an endoscope. It is a perspective view which shows the structure of the front-end | tip part of the catheter tube shown in FIG. It is the III-III sectional view taken on the line in FIG. It is the IV-IV sectional view taken on the line in FIG. It is the VV sectional view taken on the line in FIG. It is the VI-VI sectional view taken on the line in FIG. It is a partially cutaway perspective view of the tube main body in the catheter tube shown in FIG. It is a longitudinal cross-sectional view which shows the other structural example of the front-end | tip part of a catheter tube.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Catheter tube 2 Tube main body 21 Bending part 22 Middle part 23 Base end part 24 Boundary part 25 Taper part 26 Tip 31-34 Lumen 41, 42 Wire 43, 44 Tip 5 Reinforcement material layer 51 Linear body 52 Tip part 53 Tip 6 Anti-shrinkage member 61 Insertion hole 7 Tip member 71 Annular portion 72 Tapered portion 73 Base end 74 Tip 75, 76 Lumen 8 Optical fiber bundle 81 Light transmitting fiber 82 Light receiving fiber 83 Lens 9 Operating tool 91 Operating tool main body 92 Manifold part 93 Grasping Part 94 Connector 95 Branch part 96 Connector 97 Operation dial

Claims (8)

A flexible tube main body in which at least one lumen is formed along the longitudinal direction, and a tube provided at least at the tip of the tube main body so as to surround the lumen without being exposed to the surface of the tube main body A medical tube having a reinforcing material layer and a tip member joined to the tip of the tube body and made of a material harder than the material of the tube body ,
The reinforcing material layer is composed of a braided body formed in a net shape by intersecting linear bodies,
A tapered portion whose outer diameter gradually decreases toward the distal end is formed on the outer peripheral surface of the tube main body, and a tapered portion that matches the tapered portion is formed on the inner peripheral surface of the distal end member. Having an annular portion formed, the two tapered portions are bonded or fused together, and the tip member is joined to the tip of the tube body,
The outer diameter of the distal end portion of the reinforcing material layer gradually decreases toward the distal end, and is smaller than the outer diameter of the proximal end portion of the reinforcing material layer,
The medical tube, wherein a distal end of the reinforcing material layer is located between a distal end and a proximal end of the distal end member and inside or inside the annular portion . The medical tube according to claim 1 , wherein the linear body constituting the reinforcing material layer is made of a metal material, a resin material, or carbon fiber. The metallic material is a stainless steel or superelastic alloy, the resin material is polyamide, polyethylene, polypropylene, polyester, polyimide, according to claim 2 is any one selected from the group consisting of ABS resin Medical tube. The tube body has a plurality of lumens, described in at least one lumen of which has an optical fiber bundle is housed, either of claims 1 wire is accommodated in the other lumen 3 Medical tubes. The tube body has a plurality of lumens, an optical fiber bundle is accommodated in at least one of the lumens, and a wire is accommodated in the other lumens,
The medical tube according to any one of claims 1 to 3 , wherein a distal end of the wire is embedded and fixed inside the distal end member so as not to be exposed at a distal end surface of the distal end member. The tube main body is curved when the wire housed in the other lumen is pulled in the proximal direction, and a portion that is located on the proximal side from the curved portion and does not bend by pulling the wire. The medical tube according to claim 4 , wherein a distal end portion of the reinforcing material layer is located at the curved portion. An anti-shrink member that can be bent but does not substantially contract in the longitudinal direction is housed in the other lumen of the portion that does not bend by pulling the wire, and the wire is contained inside the anti-shrink member. The medical tube according to claim 6 , wherein is inserted. Wherein the anti-shrinkage member has its front end portion is fixed to said other lumen, and the distal end portion of the anti-shrinkage member to claim 7 which is located proximal to the distal portion of the reinforcement layer The medical tube described.

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