JP5951268B2 - Medical tube and method for manufacturing medical tube - Google Patents

Description

  The present invention relates to a medical tube that serves as an introduction guide for allowing an endoscope or a diagnostic or therapeutic treatment tool to reach a desired site in the body, and a method for manufacturing the medical tube, and in particular, an inner diameter of a cylindrical curved portion. The present invention relates to a medical tube that can be bent in any direction without being crushed, and a method for manufacturing the medical tube.

  In general, a medical tube inserted into a blood vessel or the like to guide a medical jig such as a catheter to a desired position in the body has a medical jig for diagnosis or treatment inserted into the medical tube with respect to the affected part. The tip part is easy to bend because it is positioned with high accuracy, and the tip part is bent using the pushability and the bendability caused by the push. There is a configuration in which a pair of operation wires are built up to an operation portion at intervals of 180 degrees, and the distal end portion is bent by pulling one operation wire in the operation portion.

  The following patent document is given as a document describing a technique related to a medical tube according to the prior art, and the following patent document 1 includes a thin outer diameter and a large inner diameter, and gradually increases the hardness from the distal end to the proximal end. Describes the manufacturing technology for medical guiding catheter tubes with backup force, anti-kink properties, and torque transmission properties by smoothly transferring the pushing force and rotational force applied at the proximal end to the distal end. Patent Document 2 describes a manufacturing technique of a guiding catheter tube in which X-ray visibility is improved by forming an inner tube from a synthetic resin containing a fluororesin and an X-ray contrast medium powder. Describes a manufacturing technique of a medical catheter tube in which the bending stiffness is gradually reduced from the proximal end portion to the distal end portion.

JP 2007-202979 A JP 2007-29510 A JP 2007-29120 A

  The medical tube described in the above-mentioned patent document improves kink resistance against bending and reduces rotational anisotropy at the tip when a twisting force in both directions is applied. Introducing into the affected area by using the bending property by pushing, it is difficult to insert into a highly refracted lumen or selectively into a branched lumen, and as a result, into the medical tube There has been a problem that it is difficult to guide an endoscope used for insertion and a medical jig for diagnosis or treatment to a desired position in an organ such as the heart, liver, or stomach. Also, in the case of a medical tube that bends the tip using the aforementioned operation wire, the pulling force acting on the bending start portion is large due to the pulling of the operation wire, and the tube is crushed in the vicinity of the start of bending in the middle of bending and the inner diameter There is a problem that the medical jig cannot smoothly insert / remove the curved portion due to the decrease in size.

  In view of such problems, the present invention is intended to solve the above-described problems caused by the prior art, and the distal end portion can be bent with a small radius of curvature, and the bending portion is crushed during the bending operation. It is an object of the present invention to provide a medical tube and a method of manufacturing a medical tube that can prevent the above-described problem, ensure an inner diameter, and smoothly insert and remove the medical jig.

  In order to achieve the above object, the present invention provides a cylindrical guide tube having a predetermined outer diameter for guiding a long medical jig through the distal end side thereof, and a guide tube attached to the proximal end side of the guide tube. A bending operation section for bending the distal end side of the tube, and the guide tube has a flexible long cylindrical flexible section, and the bending operation section is less rigid than the flexible section. The medical tube has a bending portion that is bent by the bending portion, and the bending portion has a length that is three to five times the outer diameter of the guide tube, and the proximal end side is joined to the flexible portion. A bending auxiliary portion that assists bending due to lower rigidity than the bending portion, and a bending auxiliary portion that has the same rigidity as the bending auxiliary portion and is joined to the distal end side of the bending auxiliary portion. And the pressed position in a state in which the tip bending portion is pressed. The first characterized by forming knuckles by pressure heat welding for heating from the outer periphery to the melting point temperature of the bending assist portion and the distal bending portion of the.

  Further, the present invention provides the medical tube according to the first feature, wherein the node is bent from an outer periphery of the pressing position in a state where the bending assisting portion and the distal bending portion are pressed with a metal ring interposed therebetween. In the medical tube having either the first or the second feature, the rigidity of the tip bending portion is set to be curved. A third feature is that the auxiliary portion is formed lower than the auxiliary portion.

  In addition, the present invention provides a cylindrical guide tube having a predetermined outer diameter for guiding a long medical jig through the distal end side, and is attached to the proximal end side of the guide tube. A bending operation portion for bending, and a flexible portion having a long cylindrical shape in which the guide tube is flexible, and a bending portion that is less rigid than the flexible portion and is bent by the operation of the bending operation portion. The curved portion is 3 to 5 times longer than the outer diameter of the guide tube, and the proximal end side is joined to the flexible portion and is rigid compared to the flexible portion. A plurality of bending assisting portions that assist in bending due to low and a bending end portion that has the same rigidity as the bending assisting portion and is joined to the distal end side of the plurality of bending assisting portions. In the state where the head part and the tip bending part are pressed A fourth characteristic in that forms a knuckle by pressure heat welding for heating from the outer periphery to the melting point temperature of the bending assist portion and the distal bending portion of the.

  Further, the present invention provides the medical tube of the fourth feature, wherein the node portion is pressed from the outer periphery of the pressing position in a state where the plurality of bending auxiliary portions and the tip bending portion are pressed with a metal ring interposed therebetween. According to a fifth feature of the present invention, the distal end bending portion is made to be rigid by bending the distal end bending portion in the medical tube according to the fourth or fifth feature. In the medical tube having any of the fourth to sixth characteristics, the rigidity of the plurality of bending assist parts is changed from the rigidity of the flexible part to the tip. The seventh feature is that the auxiliary portion is set to become smaller in the range of rigidity of the auxiliary portion. In the medical tube having any one of the above features, the flexible portion is made of polyamide having a hardness of 72 by the Shore hardness test method. The bay An eighth feature is that the auxiliary portion is made of a polyamide elastomer resin having a hardness of 42 to 72 according to the Shore hardness test method, and the curved tip portion is made of a polyamide elastomer resin having a hardness of 30 to 35 according to the Shore hardness test method. .

Furthermore, the present invention provides a cylindrical guide tube having a predetermined outer diameter that guides a long medical jig through the distal end side, and is attached to the proximal end side of the guide tube. A bending operation portion for bending, and a flexible portion having a long cylindrical shape in which the guide tube is flexible, and a bending portion that is less rigid than the flexible portion and is bent by the operation of the bending operation portion. A method for producing a medical tube comprising:
A bending assisting portion that is 3 to 5 times longer than the outer diameter of the guide tube, has a proximal end joined to the flexible portion, and has lower rigidity than the flexible portion, and the bending assisting portion. Forming the bending portion from a distal end bending portion having the same rigidity as that of the bending portion and joined to the distal end side of the bending assisting portion, and pressing the bending assisting portion and the distal end bending portion in a pressed state An eleventh feature is that the guide tube is manufactured by a step of forming a node portion by pressure welding welding that heats from the outer periphery of the position to the melting point temperature of the bending auxiliary portion and the tip bending portion.

  In the medical tube and the medical tube manufacturing method according to the present invention, the bending portion of the guide tube has a length three to five times the guide tube outer diameter, and the proximal end side is joined to the flexible portion. A bending auxiliary portion that assists bending due to its lower rigidity than the bending portion, and a distal bending portion that has the same rigidity as the bending auxiliary portion and is joined to the distal end side of the bending auxiliary portion. And, in the state of the bending operation, by forming the node portion by pressure welding welding that heats from the outer periphery of the pressing position to the melting point temperature of the bending auxiliary portion and the tip bending portion while pressing the tip bending portion, Since the joint is supported at the bending start position, the medical tube is not crushed, the inner diameter is secured, the medical jig can smoothly insert and remove the bending portion, and the distal end portion is bent with a small radius of curvature. Can do.

The figure for demonstrating the medical tube used as the object of this invention. The figure for demonstrating the medical tube by this embodiment. The figure for demonstrating the medical tube by 1st Embodiment of this invention. The figure for demonstrating the medical tube by 2nd and 3rd embodiment of this invention. The figure for demonstrating the medical tube by 4th embodiment of this invention. The figure for demonstrating the subject of the medical tube by a prior art.

Embodiments of a medical tube and a medical tube manufacturing method according to the present invention will be described below in detail with reference to the drawings.
[First Embodiment]
As shown in FIG. 1, a medical tube that is a subject of the present invention is a cylindrical guide tube 100 that passes a long medical jig 8 to the distal end side, and a medical jig 8 that is inserted, The guide tube 100 includes a bending operation unit 11 that is attached to the proximal end side of the guide tube 100 and is configured to bend the distal end side of the guide tube 100 by rotating the bending knob 11a. An elongated cylindrical flexible portion 40 that is inserted into a blood vessel or the like with flexibility, and has a higher flexibility (lower rigidity) than the flexible portion 40, and rotates the bending knob 11a of the bending operation portion 11. It is comprised from the bending part 30 which curves by operating.

  As shown in FIG. 2, the mechanism for bending the bending portion 30 of the medical tube includes a pair of operation wires 20a and 20b that are wound and unwound by rotation of the bending knob 11a of the bending operation portion 11. The bending knob 11a is disposed in a symmetrical position (vertical position in FIG. 1) from the bending knob 11a to the annular operation wire fastener 21 at the tip of the bending portion 30 so as to extend along the circumferentially facing position of the cylindrical inner wall. , By winding up one of the operation wires 20a or 20b extending along the circumferentially facing position of the cylindrical inner wall, and rewinding the other operation wire 20b or 20a toward the wound side. Thus, the bending portion 30 is configured to bend.

  As shown in FIG. 3, the guide tube 100 has a rigidity that can be deformed along a blood vessel or the like when inserted into the blood vessel or the like (for example, the hardness is 72 according to the Shore hardness test method defined in ISO868). The flexible portion 40 having a length of about 600 mm to 1200 mm and an outer diameter d of 3 mm to 4.3 mm (preferably 3.5 mm) is connected to the flexible portion 40 by the flexible portion 40 and the joint portion 31. The curved portion 30 is lower in rigidity and has a length of about 60 mm to 80 mm. The curved portion 30 has a length L1 (for example, about 15 mm) that is 3 to 5 times the outer diameter d, and has the same outer diameter as the outer diameter d of the flexible portion 40, and the rigidity thereof is flexible. The bending assisting portion 30a having a lower hardness (for example, about 42 to 63) than the portion 40, the length L2 (for example, about 45 mm), the outer diameter is the same as the outer diameter d of the flexible portion 40, and the rigidity is the bending. It is comprised from the front-end | tip bending part 30e same as the auxiliary | assistant part 30a. These bending assisting portions 30a and tip bending portions 30e are preferably made of nylon elastomer resin having rubber elasticity.

  In particular, the bending portion 30 according to the present embodiment is manufactured by welding by pressure bonding in a state where the bending auxiliary portion 30a made of nylon elastomer resin and the distal end bending portion 30e are heated to a melting point temperature at which the bending auxiliary portion 30e is melted. A node portion 50 such as a bamboo node is formed at a location where the tip bent portion 30e is thermally welded. Since the joint 50 is welded by welding the auxiliary bending portion 30a and the tip bending portion 30e made of nylon elastomer resin, the joint 50 is heated and melted, and the resin is hardened, so that the pressure-welding and welding portion is made of bamboo. It can be formed like a knot.

The guide tube 100 configured as described above rotates the bending knob 11a of the bending operation unit 11 described above to wind up one of the operation wires 20a or 20b extending along the circumferentially facing position of the cylindrical inner wall, By rewinding the other operation wire 20b or 20a, one of the circular rings of the operation wire tip fastener 21 is pulled and the other is pushed to bend the bending portion 30, but in the prior art, one operation wire 20a Or, since the pulling force of 20b becomes large in the vicinity of the start of bending, there is a possibility that the bending portion 30 may be crushed in the vicinity of the bending start position (a position about four times the outer diameter d from the fulcrum ▽ position in FIG. 6). Met.
On the other hand, in the present embodiment, as described above, the node 50 that prevents bending is formed at a position about 3 to 5 times the front of the bending start position, so that the hardness of the node 50 is higher than the hardness of the elastomer resin. It becomes hard and prevents crushing during the bending operation, can maintain the inner diameter and can be smoothly bent, and the bending portion 30 can be bent with a small radius of curvature.

  The manufacturing method of the node 50 is such that the core metal is inserted into the cylindrical shape made of nylon elastomer resin of the bending auxiliary portion 30a and the tip bending portion 30e, and the cylindrical operation wire insertion holes formed in 30a and 30e are previously inserted into the cylindrical operation wire insertion holes. A first step of pressing and abutting the bending auxiliary portion 30a and the tip bending portion 30e through a thick stainless steel wire (which may be a heat-resistant resin) of about 0.1 mm to 0.3 mm from the wire, and the pressing A second step of covering the periphery of the position with a heat-shrinkable tube, and shrinking the heat-shrinkable tube by heat-shrinking the periphery of the pressing position covered with the heat-shrinkable tube, and at the same time, surrounding the pressing position with the elastomer A third step in which the pressing portion of the bending auxiliary portion 30a and the tip bending portion 30e is pressed and heated by heating to the melting point temperature of the resin. And the fourth step of removing the stainless steel wire by removing the heat-shrinkable tube after returning to room temperature after the pressure welding. The pressure contact force between the bending assisting portion 3a and the distal bending portion 3e may be about 100 to 300 g. The heat-shrinkable tube is preferably made of, for example, silicon rubber (80 ° or more) that has higher heat resistance than nylon resin and shrinks at a temperature lower than the melting point of nylon elastomer resin.

  The heat-shrinkable tube that covers the periphery of the pressing position in the second step is for keeping the outer diameter dimension after molding the same as that of other parts, and may cover the periphery of the joint portion of the pressing position. In addition, the heating for the pressure welding in the third step is preferably performed so that the nylon elastomer resin reaches the melting temperature in a short time, and the melting temperature of the nylon elastomer resin is higher than 160 ° C. to 175 ° C., for example, It can be performed by applying hot air at a temperature of 240 degrees for about 1 to 2 seconds.

[Second Embodiment]
In the medical tube according to the first embodiment described above, the example in which the node portion 50 that assists the bending of the bending portion made of the nylon elastomer resin having the same hardness is provided at one place has been described. Without being limited thereto, a medical tube according to a second embodiment will be described next.

  As shown in FIG. 4 (a), the medical tube according to the second embodiment is configured to heat the bending portion 30 with a plurality of bending auxiliary portions 30a to 30d and the tip bending portion 30e in the same manner as in the manufacturing method described above. A plurality of node portions 33 are provided by welding to the flexible portion 40, and each of the bending auxiliary portions 30a to 30d has a length three times the outer diameter d of the guide tube 100 as in the first embodiment. The bending auxiliary portions 30a to 30d and the tip bending portion 30e are made of nylon elastomer resin having a uniform hardness of about 33 to 63 (preferably 42) according to the Shore hardness test method.

  The medical tube according to the second embodiment configured in this manner rotates one of the bending knobs 11a of the bending operation unit 11 so that one operation wire 20a or 20b extending along the circumferentially opposed position of the cylindrical inner wall is provided. When the other operation wire 20b or 20a is wound up and one of the annular rings of the operation wire tip fastener 21 is pulled and the other is pushed to bend the bending portion 30, the plurality of node portions 33 are provided. Thus, the curved portion 30 can be curved more smoothly than the medical tube according to the first embodiment, and the curved portion 30 can be prevented from being crushed at a plurality of locations even when the curved portion is bent by 180 degrees or more.

[Third Embodiment]
Moreover, although the medical tube by the said embodiment demonstrated the example with the same hardness of the some bending auxiliary | assistant parts 30a-30d and the front-end | tip bending part 30e, as shown in FIG.4 (b), the bending part 30 is bent. When this is done, the force to wind up one of the operation wires acts from the joint portion 31 corresponding to the seam with the flexible portion 40, so the pulling force acting on each of the bending auxiliary portions 30a to 30d is applied to the bending auxiliary portion 30a. When the pulling force acting is F1, the pulling force acting on the bending assisting portion 30b is F2, the pulling force acting on the bending assisting portion 30c is F3, and the pulling force acting on the bending assisting portion 30d is F4, the pulling force is large. In order to facilitate the bending of the bending portion 30 including the tip bending portion 30e and the bending auxiliary portions 30a to 30d, the tip bending portion 30e and the tip bending portion 30e and each The hardness of the song auxiliary section 30 a to 30 d, by configuring so as to reduce the order of the bay song auxiliary section 30a> bending assist portion 30b> bending assist portion 30c> bending assist portion 30d> distal bending portion 30e, curved or 180 degrees Even if it is the case, it may be configured so as not to be crushed. The hardness of the bending auxiliary portions 30a to 30d is, for example, 72 for the bending auxiliary portion 30a, 63 for the bending auxiliary portion 30b, 55 for the bending auxiliary portion 30c, It is preferable that the auxiliary portion 30d is set to 42 and the tip bending portion 30e is set to 33. That is, the hardness of each of the bending auxiliary portions 30a to 30d according to the present embodiment is set so as to be hard enough to withstand the proximal end side where the pulling force F is large, and is gradually decreased so as to be easily bent toward the distal end side. doing. In this case, the length of the bending portion 30 is preferably about 80 mm to 100 mm.

  In addition, the length of each of the bending assisting portions may be set so that the length of the portion near the center where the bending rate is large within the range of 3 to 5 times the diameter d is short and the lengths of other portions are long.

[Fourth Embodiment]
In the above-described embodiment, the example in which the medical tube is prevented from being crushed by the plurality of nodes is described. However, the present invention is not limited to this, and as shown in FIG. For example, a metal ring 60 made of metal may be provided in each of the joint portions 31 and the node portions 33 of 40, and the medical tube may be prevented from being crushed.

  The medical tube is provided between the flexible portion 40 and the bending auxiliary portion 30a, between the bending auxiliary portion 30a and the bending auxiliary portion 30b, between the bending auxiliary portion 30b and the bending auxiliary portion 30c, Manufactured easily by performing the aforementioned pressure welding with the metal ring 60 positioned between the bending assisting portion 30c and the bending assisting portion 30d and between the bending assisting portion 30d and the tip bending portion 30e. can do.

  The medical tube configured as described above can further prevent the tube from being crushed as compared with other embodiments. The metal ring 60 may be applied to the case where there is one bending auxiliary portion and one node portion as in the first embodiment, and the hardness of each bending auxiliary portion and bending portion is the same as in the second embodiment. The bending portion 40 may be uniform, and the hardness decreases in the order of the flexible portion 40> the bending assisting portion 30a> the bending assisting portion 30b> the bending assisting portion 30c> the bending assisting portion 30d> the tip bending portion 30e. Also good.

8 Medical jig 11 Bending operation part 11a Bending knob 20a and 20b Operation wire 21 Operation wire fastener 30 Bending part 30a-30d Bending auxiliary part 30e Tip bending part 31 Joining part 33, 33a-33d, 50 Node 40 Flexible part 60 Metal ring 100 Guide tube

Claims (6)

A cylindrical guide tube having a predetermined outer diameter that guides a long medical jig through the distal end side, and a bending operation for bending the distal end side of the guide tube attached to the proximal end side of the guide tube And a guide tube having a flexible long cylindrical shape and a bending portion that is less rigid than the flexible portion and is bent by the operation of the bending operation portion. Because
A bending assist that assists bending by the bending portion having a length three to five times the outer diameter of the guide tube and having a base end side bonded to the flexible portion and having a lower rigidity than the flexible portion. and a parts and the curved auxiliary section of the same rigid and be in the curved distal bending portion which is joined to the front end side of the auxiliary unit has a knuckle the curved auxiliary section and the distal bending portion is welded The medical tube is characterized in that the node portion has a metal ring disposed between the bending assisting portion and the distal bending portion . A cylindrical guide tube having a predetermined outer diameter that guides a long medical jig through the distal end side, and a bending operation for bending the distal end side of the guide tube attached to the proximal end side of the guide tube And a guide tube having a flexible long cylindrical shape and a bending portion that is less rigid than the flexible portion and is bent by the operation of the bending operation portion. Because
The bending portion has a length that is 3 to 5 times the outer diameter of the guide tube, a proximal end side is joined to the flexible portion, and has a lower rigidity than the flexible portion, thereby assisting bending. and a curved auxiliary section and the curved auxiliary section of the same rigid and there are plurality of distal bending portion which is joined to the front end side of the bending assist portion, the curved auxiliary section of the plurality of and the distal bending portion is welded A medical tube characterized in that a metal ring is disposed between the plurality of auxiliary bending portions and the distal end bending portion . 3. The medical tube according to claim 2 , wherein rigidity of the plurality of bending assisting parts is set so as to decrease in order within a range of rigidity of the flexible part to rigidity of the distal-end bending part. A polyamide of hardness 72 to the flexible portion in Shore hardness test method, claims 1 to 3, characterized in that a formed of polyamide elastomer resin hardness 42-72 according to the bending assist portion Shore hardness test method A medical tube according to any one of the above. A cylindrical guide tube having a predetermined outer diameter that guides a long medical jig through the distal end side, and a bending operation for bending the distal end side of the guide tube attached to the proximal end side of the guide tube And a guide tube having a flexible long cylindrical shape and a bending portion that is less rigid than the flexible portion and is bent by the operation of the bending operation portion. A manufacturing method of
A bending assisting portion that is 3 to 5 times longer than the outer diameter of the guide tube, has a proximal end joined to the flexible portion, and has lower rigidity than the flexible portion, and the bending assisting portion. A step of forming the bending portion from a distal end bending portion having the same rigidity as the portion and joined to the distal end side of the bending assisting portion, and the bending assisting portion and the distal end bending portion are pressed with a metal ring interposed therebetween . The guide tube is manufactured by a step of forming a node portion by pressure welding welding that heats from the outer periphery of the pressing position to the melting point temperature of the bending auxiliary portion and the tip bending portion in a state. Method. A cylindrical guide tube having a predetermined outer diameter that guides a long medical jig inserted through the distal end side, and a bending operation unit that is attached to the proximal end side of the guide tube and curves the distal end side of the guide tube. An elongated cylindrical flexible portion in which the guide tube is flexible, and a bending portion that is less rigid than the flexible portion and is curved by the operation of the bending operation portion,
A bending assist that assists bending by the bending portion having a length three to five times the outer diameter of the guide tube and having a base end side bonded to the flexible portion and having a lower rigidity than the flexible portion. And a distal end bending portion having the same rigidity as the bending assisting portion and joined to the distal end side of the bending assisting portion,
A method of manufacturing a medical tube in which cylindrical operation wire insertion holes are respectively formed in the bending auxiliary portion and the distal bending portion,
A core metal is pierced through the cylindrical shape of the bending assisting portion and the distal end bending portion, and the bending assisting portion and the distal end bending portion are pressed and abutted against each other through a stainless wire or a heat-resistant resin through the operation wire insertion hole. 1 process,
A second step of covering the periphery of the pressing position with a heat shrinkable tube;
The pressing position covered by the heat shrinkable tube is heated to contract the heat shrinkable tube, and at the same time, the periphery of the pressing position is heated to the melting point temperature of the bending auxiliary section and the distal end bending section. A third step of welding the portion and the pressing portion of the tip bending portion;
A fourth step of removing the stainless steel wire or the heat-resistant resin from the operation wire insertion hole after peeling the heat-shrinkable tube after the bending auxiliary portion and the tip bending portion are returned to room temperature. A method of manufacturing a medical tube.

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