JP2017169658A - Medical tube manufacturing method and manufacturing apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To manufacture a medical tube to which a biological material or medical liquid is less likely to adhere.SOLUTION: A method for manufacturing a medical tube is a method for manufacturing a medical tube having a micro concavo-convex structure on the inner surface, and includes an insertion process for inserting a mold 24 having a micro concavo-convex structure on the outer surface into a tube 2a, and a pressing process for pressing the tube 2a against the mold 24 so that the micro concavo-convex structure of the mold 24 comes in contact with the inner surface of the tube 2a.SELECTED DRAWING: Figure 5

Description

  The present invention relates to a method and apparatus for manufacturing a medical tube.

  Conventionally, for patients who have difficulty breathing spontaneously, patients who have difficulty in draining sputum by themselves, etc., the outside of the body and the trachea are directly connected to secure the airway and to suck in foreign objects such as breathing and sputum. Possible tracheal tubes are known.

  Such a tracheal tube is disclosed in Patent Document 1, for example. Specifically, Patent Document 1 discloses a lumen body provided with an airway securing lumen penetrating from a proximal end portion to a distal end portion, a connector portion formed at the proximal end portion of the lumen body, and the lumen body. A cuff that is formed on the outer periphery of the distal end side portion and capable of being expanded and contracted, a cuff inflation lumen that is formed on a wall portion that constitutes the lumen body and communicates between the surface portion of the connector portion and the inside of the cuff, and A tracheostomy tube is disclosed that includes a suction lumen formed on a wall portion constituting a lumen body and communicating the surface portion of the connector portion and the surface portion of the lumen body.

  In the tracheal tube disclosed in Patent Literature 1, by forming a suction lumen communicating with a predetermined portion on the surface of the lumen body from the surface of the connector portion on the wall portion of the lumen body, by suctioning from the connector portion side, The soot or the like accumulated between the lumen body and the trachea can be discharged to the outside through the suction lumen.

  Further, in the tracheal tube disclosed in the cited document 1, a coating that expresses surface lubricity when wet is formed on the surface of the tracheostomy tube and the inner surface forming the lumen for securing the airway of the lumen body. It is characterized by that. By adopting such a structure, when the inner surface of the luminal body is moistened due to breath or brim when the patient breathes, surface lubricity is developed, and soot or the like adheres to the inner surface of the luminal body. It is described that it becomes difficult.

JP 2006-102099 A

  However, as far as the present inventors have studied, it has been found that the tracheostomy tube described in Patent Document 1 still has room for further improvement regarding the suppression of sputum adhesion. In addition, for medical tubes used other than the tracheal tube, there is still room for further improvement in the suppression of adhesion of biological materials such as sputum or medical fluids such as infusion agents.

  An object of the present invention is to solve the above-described problems and to manufacture a medical tube that is difficult for biological substances or medical liquids to adhere thereto.

  In order to solve the above problems, a method for manufacturing a medical tube according to the present invention is a method for manufacturing a medical tube having a fine concavo-convex structure on the inner surface, and a mold having a fine concavo-convex structure on the outer surface is inserted into the tube. An insertion step, and a pressing step of pressing the tube against the mold so that the fine concavo-convex structure of the mold contacts the inner surface of the tube.

  Moreover, in order to solve the said subject, in the manufacturing method which concerns on this invention, in the said pressing process, it is preferable to press the said tube against the said metal mold | die with a pressing tool.

  Moreover, in order to solve the said subject, in the manufacturing method which concerns on this invention, the said pressing tool is cylindrical shape or a column shape, In the said pressing process, moving the said pressing tool in the circumferential direction of the said tube, It is preferable to press against the tube.

  In order to solve the above-mentioned problem, in the manufacturing method according to the present invention, the pressing tool has a disk shape, and in the pressing step, the pressing tool is pressed against the tube while moving in the axial direction of the tube. It is preferable to apply.

  Moreover, in order to solve the said subject, in the manufacturing method which concerns on this invention, it is preferable to press the said pressing tool on the said tube in the said pressing process, heating the said tube with a heating apparatus.

  Moreover, in order to solve the said subject, in the manufacturing method which concerns on this invention, it is preferable that the said heating apparatus is provided in at least one of the said metal mold | die and the said pressing tool.

  Moreover, in order to solve the said subject, in the manufacturing method which concerns on this invention, it is preferable that the said heating apparatus is a heater, an ultrasonic generator, or a high frequency generator.

  In order to solve the above problem, in the manufacturing method according to the present invention, after the pressing tool is pressed against the tube, heating of the tube by the heating device is stopped and the tube is cooled by a cooling device. It is preferable to further include a cooling step.

  Moreover, in order to solve the said subject, in the manufacturing method which concerns on this invention, the said cooling device is an air blower which generate | occur | produces an airflow in the said tube, In the said cooling process, an airflow is sent in the said tube by the said air blower. Preferably, the tube is generated to cool the tube.

  Moreover, in order to solve the said subject, it is preferable that the manufacturing method which concerns on this invention further includes the process of giving a fluorine coating to the fine concavo-convex structure formed in the inner surface of the said tube by pressing the said metal mold | die.

  In order to solve the above problems, a medical tube manufacturing apparatus according to the present invention is a medical tube manufacturing apparatus having a fine concavo-convex structure on the inner surface, and has a fine concavo-convex structure on the outer surface. An insertable mold, and a pressing tool capable of pressing the tube so that the fine uneven structure of the mold contacts the inner surface of the tube.

  According to the method and apparatus for manufacturing a medical tube according to the present invention, it is possible to provide a medical tube to which a biological substance or a medical liquid is difficult to adhere.

It is a figure which shows the state which left the tracheal tube manufactured using the manufacturing method and manufacturing apparatus of the medical tube which concerns on this invention in the trachea. It is a perspective view which shows the tube main body in the tracheal tube shown in FIG. It is an expanded sectional view which shows an example of the fine concavo-convex structure formed in the inner surface of the tube main body shown in FIG. It is a top view which shows an example of the fine concavo-convex structure shown in FIG. It is a top view which shows an example of the fine concavo-convex structure shown in FIG. It is the figure which looked at the tracheal tube shown in FIG. 1 from the base end side. It is sectional drawing which shows the structural example of the manufacturing apparatus which concerns on one Embodiment of this invention. It is a figure which shows an example of the cross-sectional shape of the metal mold | die shown in FIG. It is a figure which shows an example of the cross-sectional shape of the metal mold | die shown in FIG. It is a figure which shows an example of the cross-sectional shape of the metal mold | die shown in FIG. It is a perspective view of the pushing tool shown in FIG. It is the figure which looked at the pushing tool shown in FIG. 6 from the direction orthogonal to a central axis. It is the figure which looked at the pushing tool shown in FIG. 6 from the direction orthogonal to a central axis. It is sectional drawing which shows the other structural example of the manufacturing apparatus which concerns on one Embodiment of this invention. It is sectional drawing which shows another structural example of the manufacturing apparatus which concerns on one Embodiment of this invention. It is a flowchart which shows the manufacturing method of the tube main body which concerns on one Embodiment of this invention. It is a figure which shows the temperature change of the tube in the manufacture flow of the tube main body which concerns on one Embodiment of this invention. It is a figure which shows the evaluation result of the formation state of the fine concavo-convex structure which used the amount of crushing of a tube, and preset temperature as a parameter. It is a figure which shows the evaluation result of the formation state of the fine concavo-convex structure which made the rotation angle of the tube main body a parameter.

  Hereinafter, embodiments of a method and apparatus for manufacturing a medical tube according to the present invention will be described with reference to FIGS. Here, the manufacturing method and manufacturing apparatus of the tube main body as a medical tube used for a tracheal tube will be described as an example of the manufacturing method and manufacturing apparatus of the medical tube according to the present invention. In addition, the same code | symbol is attached | subjected to the common member and site | part in each figure.

<Tracheal tube>
First, a tracheal tube manufactured using the method and apparatus for manufacturing a medical tube according to the present invention will be described. FIG. 1 is a diagram showing a state in which a tracheal tube 1 manufactured using a medical tube manufacturing method and manufacturing apparatus according to an embodiment of the present invention is placed in the trachea. FIG. 2 is a perspective view showing a single tube body 2 as a medical tube in the tracheal tube 1. FIG. 3 is an enlarged cross-sectional view of the tube main body 2 shown in FIG. 2 and shows a fine concavo-convex structure 100 formed on the inner surface of the tube main body 2. 4A and 4B are top views of the fine concavo-convex structure 100 shown in FIG. FIG. 5 is a view of the tracheal tube 1 as seen from the proximal end side. As shown in FIG. 1, a tracheal tube 1 is attached to a tube body 2, a contractible and expandable cuff 3 attached on the outer peripheral surface of the tube body 2, and one end of the tube body 2. And a flange member 4.

  As shown in FIG. 2, the tube main body 2 is described as a distal end portion 8 including the distal end 5 and an extending direction of the central axis O1 of the inner peripheral surface of the tube main body 2 (hereinafter simply referred to as “central axial direction A”). ) On the proximal end 6 side of the distal end portion 8 and the cuff mounting portion 9 to which the cuff 3 is attached on the outer peripheral surface; the bending portion 10 continued on the proximal end 6 side of the cuff mounting portion 9; 10 and the base end portion 11 including the base end 6.

  The tube body 2 defines a hollow portion 7 that penetrates from the distal end 5 to the proximal end 6 in the central axial direction A. The tube main body 2 includes first to third lumens 12 to 14 that are formed in the wall and extend in the central axis direction A from a base end opening defined on the base end surface. The hollow portion 7 can secure an airway in a state where the tracheal tube 1 is inserted and indwelled from the outside into the trachea. The first lumen 12 extends from the first base end opening 12a to the suction port provided on the base end 6 side with respect to the cuff 3, and is upstream of the trachea than the cuff 3 in a state of being placed in the trachea. It is used for sucking and removing foreign substances X such as sputum, saliva, aspiration, blood, etc. stored on the jaw side. The second lumen 13 extends from the second proximal end opening 13a to a suction port provided on the distal end 5 side of the cuff 3, and is located downstream of the trachea (tracheal branch) from the cuff 3 placed in the trachea. Used to suck and remove foreign matter X such as wrinkles stored near the tip 8. The third lumen 14 extends from the third base end opening 14 a to the communication port 14 b provided at the position of the cuff 3 and is used for contracting and expanding the cuff 3. In addition, although it is a hollow part also about the small diameter 1st-3rd lumens 12-14 divided in the wall, in order to distinguish from the large diameter hollow part 7 for securing an airway for convenience of explanation, here, It is described as “lumen”.

  As shown in FIG. 3, the fine uneven structure 100 is formed in the inner peripheral surface of the tube main body 2 as a medical tube. The fine concavo-convex structure 100 is constituted by unevenness of several μm to several hundred μm. The region where the fine concavo-convex structure 100 is formed has a property of suppressing adhesion of wrinkles (hereinafter referred to as “repellency”). Details of the method of forming the fine relief structure 100 on the inner peripheral surface of the tube body 2 will be described later. The fine concavo-convex structure 100 may be formed over the entire inner peripheral surface of the tube body 2 or may be formed only on a part of the inner peripheral surface. Specific examples of the fine concavo-convex structure 100 include not only a structure that continues in the central axis direction A of the tube body 2 such as a line & space (L & S) structure, but also a plurality of columnar, conical, and frustum-shaped protrusions. A discontinuous structure in which a plurality of depressions or a combination of these is arranged may be used.

  With reference to FIG. 4A and FIG. 4B, the structure of the fine concavo-convex structure 100 is demonstrated in detail.

  4A is a top view when the fine concavo-convex structure 100 is a line and space structure, in which the horizontal direction in FIG. 4A indicates the central axis direction A of the tube body 2 and the vertical direction indicates the circumferential direction B of the tube body 2. Show. As described above, the fine concavo-convex structure 100 is a concavo-convex structure having a size of several μm to several hundreds of μm, preferably several μm to several tens of μm. When the fine concavo-convex structure 100 is a line and space structure, as shown in FIG. 4A, the convex ribs 101 and the concave grooves 102 extending in the central axis direction A of the tube body 2 are alternately arranged in the circumferential direction B. Structure.

  4B is a top view when the fine uneven structure 100 is a pillar structure in which a plurality of protrusions 103 are arranged. The horizontal direction of FIG. 4B indicates the central axis direction A of the tube body 2, and the vertical direction is The circumferential direction B of the tube main body 2 is shown. As described above, the fine concavo-convex structure 100 is a concavo-convex structure having a size of several μm to several hundreds of μm, preferably several μm to several tens of μm. In FIG. 4B, the frustoconical protrusions 103 are arranged in a predetermined arrangement.

  The line and space structure may be a structure in which the convex ribs 101 and the concave grooves 102 extending in the circumferential direction B are alternately arranged in the central axis direction A. However, foreign matter X such as wrinkles on the surface having a line-and-space structure (see FIG. 1) easily moves in the extending direction of the convex rib 101 and the concave groove 102, so that the foreign matter X remains in the tube body 2. 4A, the convex rib 101 and the concave groove 102 are preferably extended in the central axis direction A. Further, the shape of the protrusion 103 constituting the pillar structure is not limited to the truncated cone shape shown in FIG. 4B, and as described above, a cone shape, a cylindrical shape, a triangular pyramid shape, or other polygonal pyramid shapes, a rectangular column It can also be a shape or the like.

  As described above, the fine concavo-convex structure 100 is a concavo-convex structure having a size of several μm to several hundreds of μm, preferably a size of several μm to several tens of μm. Alternatively, the distance between the centers of the protrusions 103 in the pillar structure (hereinafter, the convex ribs 101 and the protrusions 103 are simply referred to as “convex portions”) is preferably 10 μm to 100 μm, and more preferably 10 μm to 50 μm. preferable. When it is larger than 100 μm, wrinkles easily enter between the convex portions, and the effect of repellency is reduced. On the other hand, when the thickness is less than 10 μm, the contact area between the ridge and the convex portion is increased, and the effect of repellency is reduced.

  Moreover, when the size of the fine concavo-convex structure 100 is the above conditions, the maximum width of the top surface 105 (see FIG. 3) of each convex portion is preferably 0.01 μm to 50 μm, and preferably 1 μm to 50 μm. More preferably, it is still more preferably 1 μm to 30 μm, and particularly preferably 1 μm to 20 μm. When it is larger than 50 μm, the contact area with the heel increases, and the repellency effect decreases. On the other hand, when the thickness is less than 0.01 μm, it is difficult to form the convex portion, and the shape stability may be lowered. When the fine concavo-convex structure 100 is a line and space structure, the maximum width of the top surface 105 (see FIG. 3) of each convex portion is the maximum length of the top surface 105 in the direction orthogonal to the extending direction of the convex rib 101. It becomes.

  Furthermore, the size of the fine concavo-convex structure 100 is under the above conditions, and the maximum height of the convex portion of the fine concavo-convex structure 100 is several μm to several hundred μm, preferably several μm to several tens μm.

  Referring to FIG. 3 again, a fluorine coat layer 200 is formed on the surface of the fine relief structure 100. The fluorine coat layer 200 is not particularly limited as long as it has a fluororesin as a main component. Examples of the fluororesin include polytetrafluoroethylene (PTFE), polychlorotrifluoroethylene (PCTFE, CTFE), polyvinylidene fluoride (PVDF), polyvinyl fluoride (PVF), perfluoroalkoxy fluororesin (PFA), tetrafluoroethylene. An ethylene / hexafluoropropylene copolymer (FEP), an ethylene / tetrafluoroethylene copolymer (ETFE), an ethylene / chlorotrifluoroethylene copolymer (ECTFE), or the like can be used.

  As a constituent material of the tube body 2, for example, polyvinyl chloride such as silicone and soft polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile- Various resins such as butadiene-styrene copolymer, polyester such as polyethylene terephthalate, butadiene-styrene copolymer, and polyamide (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12) can be used. . Among them, it is preferable to use a resin such as soft polyvinyl chloride, polypropylene, cyclic polyolefin, polyester, and poly- (4-methylpentene-1) because it is easy to mold.

  The cuff 3 is used to place the tracheal tube 1 at a predetermined position in the trachea. Specifically, the cuff 3 expands when a fluid is supplied through the third lumen 14 and contracts when the fluid is sucked. When the cuff 3 is expanded, the outer surface of the cuff 3 is in close contact with the inner wall of the trachea. The cuff 3 is held between the inner peripheral surface of the trachea and the like by the frictional force between the outer surface of the cuff 3 and the tracheal inner wall. In this way, the position of the cuff 3 in the trachea is fixed, and the tracheal tube 1 can be placed at a predetermined position in the trachea.

  As shown in FIG. 1, the flange member 4 is attached to the base end portion 11 (see FIG. 2 and the like) of the tube body 2, and when the tube body 2 is inserted into the trachea from outside the body, the tracheal tube 1 is placed. Furthermore, the tip 8 is fixed at an appropriate position in the trachea by contacting the skin. As shown in FIGS. 1 and 5, the flange member 4 is a cylindrical tube that is fitted to the tube body 2 by fitting the tube body 2 with the proximal end portion 11 of the tube body 2 inserted therein. And a plate-like flange portion 18 that protrudes radially outward from the outer wall of the cylindrical portion 17 and abuts against the skin in a state where the tracheal tube 1 is indwelled. In FIG. 5, for convenience of explanation, the positions of the first lumen 12, the second lumen 13, and the third lumen 14 of the tube body 2 are indicated by a two-dot chain line.

  As shown in FIG. 5, the cylindrical portion 17 has communication holes 17 a and 17 b that communicate with the first lumen 12, the second lumen 13, and the third lumen 14, respectively, at positions closer to the base end than the flange portion 18. And 17c are partitioned, and in a state where the proximal end portion 11 of the tube body 2 is fitted in the cylindrical portion 17, the first lumen 12, the second lumen 13, and the third lumen 14 are It communicates with the outside of the tracheal tube 1 through corresponding communication holes 17a, 17b, and 17c, and a medical tube different from the tube body 2 is connected to each of the communication holes 17a to 17c.

  Specifically, the first lumen 12 communicates with the outside of the tracheal tube 1 on the proximal end side of the tracheal tube 1 through a corresponding communication hole 17 a formed in the cylindrical portion 17. Accordingly, if suction is performed by connecting a syringe or a suction pump to the other end of the suction tube 19 as a medical tube having one end fitted into the communication hole 17a of the cylindrical portion 17 exposed outside the body, A foreign substance X such as a bag can be sucked through the first lumen 12. Further, the second lumen 13 is the same as the first lumen 12, and the foreign substance X is sucked through the suction tube 40 as a medical tube, the corresponding communication hole 17 b formed in the cylindrical portion 17, and the second lumen 13. can do.

  Further, the third lumen 14 communicates with the outside of the tracheal tube 1 on the proximal end side of the tracheal tube 1 through a corresponding communication hole 17 c formed in the cylindrical portion 17. Therefore, if a syringe or the like is connected to the other end of the cuff tube 41 as a medical tube whose one end is fitted to the communication hole 17c of the cylindrical portion 17 exposed outside the body, the operation of the syringe etc. outside the body The supply and suction of fluid to the annular space of the cuff 3 can be performed, whereby the expansion and contraction of the cuff 3 can be manipulated.

  The cylindrical portion 17 of the flange member 4 is mounted concentrically with the proximal end portion 11 of the tube body 2, and the position of the first lumen 12, the position of the second lumen 13 in the circumferential direction B of the tube body 2, The position of the third lumen 14 is set in the vicinity of the position in the circumferential direction B of the corresponding communication holes 17a, 17b, and 17c of the cylindrical portion 17. Therefore, each communicating hole 17a, 17b, 17c can be shortened, and it is suppressed that the structure of the communicating holes 17a, 17b, and 17c of the cylinder part 17 becomes complicated. Further, as shown in FIG. 5, the suction tubes 19 and 40 and the cuff tube 41 are arranged in the direction in which the flange portion 18 protrudes from the communication holes 17a, 17b, and 17c in the plan view of FIG. It connects so that it may extend, and it does not extend to the front-end | tip part 8 side. By connecting in this manner, the suction tubes 19 and 40 and the cuff tube 41 are prevented from colliding with the patient's jaw and neck while the tracheal tube 1 is placed in the trachea. The discomfort of the patient in which 1 is placed can be reduced.

  As a constituent material of the flange member 4, for example, it can be formed of the same material as that of the tube body 2.

<Manufacturing apparatus for tube body 2>
FIG. 6 is a cross-sectional view illustrating a configuration example of the manufacturing apparatus 20 for the tube body 2 as the medical tube manufacturing apparatus according to the present embodiment. The manufacturing apparatus 20 according to the present embodiment has a hollow portion extending in the axial direction, and is fine on the inner surface of the tube 2a in which the fine uneven structure 100 (see FIGS. 3 and 4) is not formed on the inner surface of the hollow portion. It is a manufacturing apparatus that forms the concavo-convex structure 100 and manufactures the tube body 2 as a medical tube.

  The manufacturing apparatus 20 illustrated in FIG. 6 includes a stage 21, support portions 22 and 23, a mold 24, and a pressing tool 25.

  On the stage 21, the support part 22 and the support part 23 are provided so as to oppose each other with a predetermined distance.

  The mold 24 is a metal columnar or cylindrical member. One end of the mold 24 is supported by the support portion 22 and the other end is supported by the support portion 23 so as to be separated from the stage 21.

  7A to 7C are diagrams illustrating an example of a cross-sectional shape of the mold 24 viewed from the axial direction. In FIG. 6, a cylindrical mold 24 is shown, but in FIGS. 7A to 7C, the mold 24 is assumed to be columnar. The mold 24 has, for example, a circular (FIG. 7A), hexagonal (FIG. 7B), or octagonal (FIG. 7C) cross-sectional shape. On the outer surface (surface) of the mold 24, a fine uneven region 24a in which a fine uneven structure is formed is provided along the axial direction. As shown in FIGS. 7A to 7C, the fine uneven region 24 a may be provided only on a part of the outer surface of the mold 24, or may be provided on the entire outer surface of the mold 24. The pattern of the fine concavo-convex structure formed in the fine concavo-convex region 24 a is a pattern obtained by inverting the concavo-convex pattern of the fine concavo-convex structure 100 (see FIGS. 3 and 4) formed on the inner surface of the tube body 2.

  Referring to FIG. 6 again, the support portion 22 is provided with an annular flange 22a that protrudes toward the support portion 23 side. The support portion 23 is provided with an annular flange 23a that protrudes toward the support portion 22 at a height position substantially equal to the flange 22a. The outer diameters of the flanges 22a and 23a viewed from the axial direction of the mold 24 are the same as or slightly smaller than the inner diameter of the tube 2a. Further, the inner diameters of the flanges 22 a and 23 a viewed from the same direction are the same as or larger than the outer diameter of the mold 24. Therefore, as shown in FIG. 6, with the mold 24 inserted into the hollow portion of the tube 2a and the tube 2a supported (fixed) by the flanges 22a and 23a, the outer surface of the mold 24 and the inner surface of the tube 2a There is a gap between the two. The flanges 22a and 23a are formed on the outer surface of the axial end of the mold 24, and a gap is formed between the outer surface of the mold 24 and the inner surface of the tube 2a at a position between the flanges 22a and 23a. It is good also as a structure.

  The mold 24 shown in FIG. 6 is cylindrical as described above, and the mold 24 is provided with a through portion 24b penetrating in the axial direction. By providing the through portion 24 b, an airflow along the axial direction can be introduced into the mold 24, and thereby the tube 2 a can be cooled via the mold 24.

  As shown in FIG. 8, the pusher 25 is a disk-shaped member, and can rotate around the central axis 25 a. The pusher 25 is provided so that the central axis 25 a is orthogonal to the axial direction of the mold 24, and is movable while rotating along the axial direction of the mold 24.

  9A and 9B are views of the pusher 25 viewed from a direction orthogonal to the central axis 25a. The pusher 25 may have a simple circumferential surface as shown in FIG. 9A, for example, as shown in FIG. 9A. It may be a concave peripheral surface (for example, recessed in a semicircular shape). If it is set as the concave peripheral surface of FIG. 9B, compared with the case where it is set as the simple peripheral surface of FIG. 9A, the contact area of the circumferential part of the pushing tool 25 and the outer surface of the tube 2a can be ensured more widely.

  The pressing tool 25 is installed to be movable along the axial direction of the mold 24 while maintaining a constant distance between the circumferential portion and the mold 24. The distance between the pressing tool 25 and the mold 24 is equal to or less than the thickness of the wall portion of the tube 2a. Therefore, the pressing tool 25 is in a state in which the tube 2a is sandwiched between the mold 24 (in a state where the tube 2a is pressed so that the inner surface of the tube 2a is in contact with the fine uneven region 24a of the mold 24). It can move along the axial direction. In a state where the tube 2a is sandwiched between the mold 24 and the pressing tool 25, the pressing tool 25 moves along the axial direction of the mold 24, so that the fine irregularities 24a formed on the inner surface of the tube 2a are finely formed. A fine concavo-convex structure 100 (see FIGS. 3 and 4) having a pattern obtained by inverting the concavo-convex structure can be formed (transferred). As shown in FIGS. 7A to 7C, when the fine uneven region 24 a is formed on a part of the outer surface of the mold 24, the circumferential portion of the pusher 25 faces the fine uneven region 24 a of the mold 24. Is set as follows.

  In addition, you may provide the heating apparatus which heats the tube 2a, such as a heater, an ultrasonic generator, and a high frequency generator, in at least one of the metal mold | die 24 and the pressing tool 25. FIG. In this case, by pressing the tube 2a with the pressing tool 25 while heating the tube 2a with the heating device, it is possible to easily transfer the fine concavo-convex structure to the inner surface of the tube 2a. Examples of the position where the heating device is provided include the through portion 24b of the mold 24, but the position is not limited to this position. It is preferable to cool the tube 2a with a cooling device after the fine concavo-convex structure 100 is transferred to the inner surface of the tube 2a by pressing the tube 2a onto the mold 24 with the pressing tool 25. Any cooling device may be used as long as it can cool the tube 2a after the fine concavo-convex structure 100 is transferred. Therefore, for example, the cooling device can be a blower 27 such as a cooling fan that generates an air flow in the tube 2a. For example, as shown in FIG. 6, the air blower 27 introduces an air flow into the penetrating portion 24 b of the mold 24 and quickly cools the tube 2 a through the mold 24, so that the inner surface of the tube 2 a is fine. The uneven structure 100 can be stably formed. Note that an air flow along the axial direction of the mold 24 may be generated between the outer surface of the mold 24 and the inner surface of the tube 2 a by the blower 27.

  In the present embodiment, the pusher 25 has been described using an example of a disk shape, but is not limited thereto. For example, as shown in FIG. 10, the pusher 25 has a long cylindrical shape. Alternatively, it may be cylindrical. In FIG. 10, the cylindrical pressing tool 25 is shown. In this case, the axial direction of the pressing tool 25 is set parallel to the axial direction of the mold 24, and the circumferential portion of the pressing tool 25 is installed so as to maintain a certain distance from the mold 24. The distance between the mold 24 and the cylindrical pressing tool 25 is the same as or less than the thickness of the wall portion of the tube 2a, as in FIG. The pusher 25 is provided to be rotatable along the circumferential direction of the mold 24.

  The columnar pressing tool 25 rotates along the circumferential direction of the mold 24 while pressing the tube 2a, so that the fine pattern of the fine uneven structure formed in the fine uneven area 24a of the mold 24 is reversed. The uneven structure 100 can be formed (transferred) on the inner surface of the tube 2a. In the manufacturing apparatus 20 shown in FIG. 10, the fine uneven region 24 a is preferably formed on the entire outer surface of the mold 24.

  Further, as shown in FIG. 11, a cooling device 26 different from the above-described air blower 27, such as a cooling fan that generates an airflow for cooling the tube 2a around the tube 2a arranged around the mold 24. May be provided. In addition, in FIG. 11, although the column-shaped metal mold | die 24 is shown, it is good also as a cylindrical metal mold | die 24 as shown in FIG. Moreover, in FIG. 10, although the disk-shaped pressing tool 25 is shown, it is good also as a column-shaped or cylindrical pressing tool 25 as shown in FIG.

<Method for manufacturing tube body 2>
Next, the manufacturing method of the tube main body 2 as a medical tube which concerns on this embodiment is demonstrated.

  FIG. 12 is a flowchart showing a method for manufacturing the tube body 2 as a method for manufacturing a medical tube according to the present embodiment. FIG. 13 is a diagram illustrating a temperature change of the tube 2 a in the manufacturing flow of the tube body 2. In addition, below, it demonstrates using the example which uses the manufacturing apparatus 20 (FIG. 6) in which the pressing tool 25 is a disk shape.

  First, the tube 2a in which the fine uneven structure is not formed on the inner surface is set in the mold 24 (step S11). Specifically, the mold 24 is inserted into the hollow portion of the tube 2a.

  Next, the tube 2a positioned around the mold 24 is preheated by a heating device provided on at least one of the mold 24 and the pressing tool 25 (step S12). Due to the heating by the heating device, the temperature of the tube 2a rises to a predetermined set temperature T, as shown in FIG.

  When a predetermined time elapses after the temperature of the tube 2a reaches the set temperature T due to preheating, transfer of the fine uneven structure to the inner surface of the tube 2a is started (step S13). Specifically, the tube 2 a is pressed against the mold 24 by the pressing tool 25 and is moved along the axial direction of the mold 24 while rotating the pressing tool 25.

  When the movement of the pressing tool 25 along the axial direction of the mold 24 is completed, heating by the heating means is stopped, and an air flow is introduced into the through portion 24b of the mold 24, and only for a predetermined time (for example, 1 minute), The tube 2a is cooled (air cooling).

  When the heated tube 2 a is pressed against the mold 24 by the pressing tool 25, the tube 2 a sticks to the mold 24. Therefore, after air cooling, the tube 2a is peeled off from the mold 24 (step S15). Hereinafter, this process is referred to as a mold peeling process.

  After the mold peeling process, when the transfer to the entire area where the fine uneven structure needs to be formed is completed, the tube 2a is removed from the mold 24 (step S16). By doing so, the fine relief structure 100 is formed on the inner surface of the tube 2a. When the transfer to the entire area where the fine uneven structure needs to be formed is not completed, the tube 2a is rotated (step S17), and the process returns to step S12.

  After forming the fine uneven structure 100 on the inner surface of the tube 2a and removing the tube 2a from the mold 24, the surface of the fine uneven structure 100 formed on the inner surface of the tube 2a is coated with fluorine, and the fluorine coating layer 200 (FIG. 3) (step S18). The step of forming the fluorine coat layer 200 will be specifically described. First, the fluorine coating agent containing the above-mentioned fluororesin is applied to the surface of the fine concavo-convex structure 100 formed on the inner surface of the tube 2a. As a method of applying the fluorine coating agent, a method of immersing the tube 2a in which the fine uneven structure 100 is formed on the inner surface in a solvent containing the fluorine coating agent, a solvent containing the fluorine coating agent is used for the tube 2a. Examples thereof include a method of pouring into the hollow portion, a method of spraying on the inner surface of the tube 2a with a spray, and a method of applying to the inner surface of the tube 2a using a gutter member. Next, the tube 2a is dried in a state where the solvent containing the fluorine coating agent is applied. The solvent is removed and a film of the fluorine coating agent is formed. Next, the fluorine coating agent is cured to form a bond with the inner surface of the tube 2a. As an example of an aspect of curing the fluorine coating agent, for example, the tube 2a can be put into an oven (not shown) and cured by heating at a predetermined temperature for a predetermined time in the oven. The set temperature is preferably about 70 to 100 degrees, more preferably 80 degrees, and the heating time is preferably about 30 to 90 minutes. In this way, the fluorine coat layer 200 is formed on the surface of the fine concavo-convex structure 100.

  By applying a fluorine coating on the surface of the fine concavo-convex structure 100, the water repellency, oil repellency and friction resistance of the inner surface of the tube 2a can be improved, and the strength of the fine concavo-convex structure 100 formed on the inner surface of the tube 2a. Can be improved. Therefore, for example, in the process of bending the tube 2a in order to form the bending portion 10 of the tube main body 2 shown in FIG. 2, the fine concavo-convex structure 100 can be made difficult to be damaged. However, the step of applying the fluorine coating described above may be performed after the tube 2a is bent.

  Of the manufacturing processes of the tube main body 2 as a medical tube, processes other than the process of forming the fine uneven structure on the inner surface of the tube 2a are the same as the manufacturing process of the conventional tube main body, and thus the description thereof is omitted. .

  FIG. 14 is a diagram showing the evaluation result of the formation state of the fine concavo-convex structure with the amount of crushing of the tube 2a by the pressing tool 25 and the set temperature T at the time of transfer as parameters. In FIG. 14, the tube 2a made of polyvinyl chloride is used, the amount of crushing of the tube 2a is 0.09 mm, 0.26 mm, and 0.43 mm, and the set temperatures T are 155 ° C., 165 ° C., and 175 ° C. The evaluation result is shown. In FIG. 14, “good” indicates that a fine uneven structure is formed on the entire inner surface of the tube body 2. Further, “defective” indicates that there is a portion where the formation of the fine concavo-convex structure is insufficient even partly.

  As shown in FIG. 14, when the crushing amount was 0.09 mm, the evaluation result was “defective” regardless of the set temperature T. When the set temperature T was 155 ° C., the evaluation result was “bad” regardless of the amount of crushing. On the other hand, when the crushing amount was 0.26 mm or more and the set temperature T was 165 ° C. or more, the evaluation result was “good”. From this, it can be understood that a temperature of a predetermined value or higher and a crushing amount (pressing force) of a predetermined value or higher are necessary for good transfer of the fine uneven structure to the inner surface of the tube body 2.

  FIG. 15 is a diagram showing the evaluation result of the formation state of the fine concavo-convex structure with the rotation angle of the tube 2a after the mold peeling process as a parameter. 15, the tube 2a having an inner diameter of 8 mm, an outer diameter of 11.5 mm, and a length of 100 mm, and a disk-like pressing tool 25 (diameter shown in FIG. 9B having a concave peripheral surface recessed radially inward. 27 mm, the dent is a radius of curvature = 6 mm, and the width is 8 mm), and the evaluation results when the rotation angle of the tube 2a is 30 °, 45 °, 60 °, 72 °, 90 ° are shown. In FIG. 15, “good” indicates a state in which a fine uneven structure is formed on the entire inner surface of the tube body 2. Further, “defective” indicates a state where there is a portion where the fine uneven structure is not formed on the inner surface of the tube body 2. In addition, “overlap” means that the fine concavo-convex structure is transferred to the entire inner surface of the tube main body 2, but there are too many overlapping portions (portions where the transferred fine concavo-convex structure overlaps). It does not have an uneven structure and shows an undesirable state.

  As shown in FIG. 15, when the rotation angle was 30 °, the evaluation result was “overlapping”. When the rotation angle is 30 °, the evaluation result is “overlapping” (the overlapping portion is generated). The circumferential transfer distance (angle) transferred by one transfer is the tube rotation distance (angle). This is because it is larger than Further, when the rotation angle was 60 ° or more, the evaluation result was “defective”. On the other hand, when the rotation angle is 45 °, the evaluation result was “good”. From this, the rotation angle depends on the size (diameter) of the tube 2a, the shape of the circumferential portion of the pusher 25, and the like. It can be seen that the fine concavo-convex structure can be satisfactorily transferred to the inner surface of the tube main body 2 by adjusting.

  As described above, the manufacturing method of the medical tube according to the present embodiment includes an insertion step of inserting the mold 24 having the fine concavo-convex structure on the outer surface into the tube 2a having no fine concavo-convex structure on the inner surface, And a pressing step of pressing the tube 2a against the mold 24 so that the fine concavo-convex structure of the mold 24 contacts the inner surface of the tube 2a.

  By pressing the tube 2a against the mold 24 so that the fine concavo-convex structure of the mold 24 is in contact with the inner surface of the tube 2a in a state where the mold 24 having the fine concavo-convex structure formed on the outer surface is inserted into the tube 2a, Since the fine concavo-convex structure corresponding to the fine concavo-convex structure formed in the mold 24 is formed on the inner surface of the tube 2a, the tube body 2 having the fine concavo-convex structure 100 formed on the inner surface can be manufactured. In particular, according to the manufacturing method according to the present embodiment, since the fine concavo-convex structure is transferred to the tube 2a by pressing the pressing tool 25 against the mold 24, unlike the extrusion molding, the axial direction of the tube main body 2 is not suitable. It is also easy to form a fine uneven structure such as a continuous protrusion.

  The manufacturing method and the manufacturing apparatus of the medical tube according to the present invention are not limited to the specific configurations described in the above-described embodiments, and various types are possible without departing from the gist of the invention described in the claims. It is possible to make changes. For example, in the above-described embodiment, the method for manufacturing the tube body 2 as a medical tube has been described. However, the method for manufacturing a tube according to the present invention is not limited to the tube body of a tracheal tube, and is used for other applications and purposes. The present invention is also applicable as a method for manufacturing a medical tube.

  Examples of the medical tube that can be manufactured by the manufacturing method and the manufacturing apparatus according to the present invention include (1) Oral or nasal insertion or digestion into the digestive organ, such as a gastric tube catheter, nutritional catheter, and tube feeding tube. Indwelling catheters; (2) Oxygen catheters, endotracheal tubes, intratracheal aspiration catheters, or other catheters that are inserted or indwelled orally or intranasally into the trachea; (3) Urinary catheters, urinary catheters Urethra balloon catheter catheters, balloons and other urethra or catheters inserted or placed in the ureter; (4) inserted or placed in various body cavities, organs, tissues such as suction catheters, drainage catheters, rectal catheters, etc. Catheters; (5) infusion tubes, IVH (abbreviation for intravenous hyperalimentation) catheters, -Modulation catheters, angiographic catheters, vasodilator catheters and catheters that are inserted or placed indirectly or directly into blood vessels such as dilators or introducers; (6) artificial trachea, artificial bronchi, etc. Medical artificial tubes; (7) Circuits for medical devices for extracorporeal circulation treatment (artificial lungs, artificial hearts, artificial kidneys, etc.).

  According to the various medical tubes manufactured by the manufacturing method and the manufacturing apparatus according to the present invention, it is possible to suppress adhesion of a wide range of biological substances or medical liquids to the inner surface. Examples of the “biological substance” include whole blood, plasma, serum, sweat, stool, urine, saliva, tears, vaginal fluid, prostate fluid, gingival exudate, amniotic fluid, eye fluid, cerebrospinal fluid, semen , Sputum, ascites, pus, nasopharyngeal fluid, wound exudate, aqueous humor, vitreous humor, bile, earwax, endolymph, perilymph, gastric fluid, mucus, ascites, pleural effusion, sebum, vomit, and combinations thereof , Etc. Examples of the “medical liquid” include infusion agents, nutrients, contrast agents, embolic agents used in hepatic artery chemoembolization (TACE), and the like.

  Although the present invention has been described based on the drawings and embodiments, it should be noted that those skilled in the art can easily make various variations or modifications based on the present disclosure. Therefore, it should be noted that these variations or modifications are included in the scope of the present invention. For example, functions included in each block or step can be rearranged so as not to be logically contradictory, and a plurality of blocks or steps can be combined into one or divided.

1 Tracheal tube 2 Tube body (medical tube)
2a Tube 3 Cuff 4 Flange member 5 Tube body distal end 6 Tube body proximal end 7 Hollow portion 8 Tube body distal end portion 9 Tube body cuff mounting portion 10 Tube body curved portion 11 Tube body proximal end portion 12 1st Lumen 12a 1st base end opening 13 2nd lumen 13a 2nd base end opening 14 3rd lumen 14a 3rd base end opening 14b Communication port 17 Tubular part 18 Flange part 19, 40 Suction tube 20 Manufacturing apparatus 21 Stages 22, 23 Support part 22a, 23a Flange 24 Mold 24a Fine uneven area 24b Penetration part 25 Pusher 25a Center shaft 26 Cooling device 27 Blower (cooling device)
41 Cuff tube 100 Fine uneven structure 101 Convex rib 102 Concave groove 103 Protrusion 105 Top surface 200 Fluorine coat layer

Claims (11)

A method for producing a medical tube having a fine relief structure on the inner surface,
An insertion step of inserting a mold having a fine relief structure on the outer surface into the tube;
And a pressing step of pressing the tube against the mold so that the fine concavo-convex structure of the mold contacts the inner surface of the tube. The manufacturing method according to claim 1,
In the pressing step, the tube is pressed against the mold by a pressing tool. In the manufacturing method of Claim 2,
The pusher is cylindrical or columnar,
In the pressing step, the pressing tool is pressed against the tube while being moved in the circumferential direction of the tube. In the manufacturing method of Claim 2,
The pusher has a disk shape,
In the pressing step, the pressing tool is pressed against the tube while being moved in the axial direction of the tube. In the manufacturing method as described in any one of Claim 1 to 4,
In the pressing step, the pressing tool is pressed against the tube while the tube is heated by a heating device. In the manufacturing method of Claim 5,
The said heating apparatus is a manufacturing method provided in at least one of the said metal mold | die and the said pressing tool. In the manufacturing method of Claim 5 or 6,
The manufacturing method, wherein the heating device is a heater, an ultrasonic generator, or a high-frequency generator. In the manufacturing method as described in any one of Claim 5 to 7,
The manufacturing method further includes a cooling step of stopping the heating of the tube by the heating device and cooling the tube by a cooling device after the pressing tool is pressed against the tube. In the manufacturing method of Claim 8,
The cooling device is a blower that generates an air flow in the tube,
In the cooling step, the air blowing device generates an air flow in the tube to cool the tube. In the manufacturing method as described in any one of Claim 1 to 9,
The manufacturing method which further includes the process of performing a fluorine coating to the fine concavo-convex structure formed in the inner surface of the said tube by pressing the said metal mold | die. A medical tube manufacturing apparatus having a fine relief structure on the inner surface,
A mold having a fine concavo-convex structure on the outer surface and insertable into the tube;
A pressing device capable of pressing the tube so that the fine uneven structure of the mold contacts the inner surface of the tube.

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