JP6621692B2 - Manufacturing method of medical tube - Google Patents

Description

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

  Traditionally, for patients who have difficulty breathing spontaneously, patients who have difficulty discharging sputum by themselves, the trachea that can directly connect the outside of the body and the trachea, secure the airway, and suck in foreign objects such as sputum 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 Patent 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.

  Accordingly, an object of the present invention is to provide a method for producing a medical tube to which biological substances or medical liquids are difficult to adhere.

  A method for manufacturing a medical tube as a first aspect of the present invention is a method for manufacturing a medical tube having an inner peripheral surface on which a fine concavo-convex structure is formed, and is a sheet-like first method having a fine concavo-convex pattern on the surface. A gap is formed between the step of winding the first mold around the core pin so that the surface is the outer surface, and the inner surface of the second mold in the inner space of the second mold. A step of inserting the core pin around which the first mold is wound, a step of filling the gap with a molding material to form a tube, a step of pulling out the core pin, and the first die Peeling from the tube.

  Moreover, it is preferable that the said core pin has the ejection hole which can eject gas in an outer surface, and makes a gas eject from the said ejection hole in the process of extracting the said core pin.

  The core pin has an inner layer having the ejection holes and an outer layer having a communication hole and positioned radially outward from the inner layer, and the ejection holes communicate with the outside through the communication holes. It is preferable that the state and the shielding state in which the ejection hole is shielded by the outer layer can be switched.

  The core pin can be radially reduced, and it is preferable that the core pin is reduced in diameter in the step of pulling out the core pin.

  The first mold preferably has a melting point higher than that of the molding material.

  Furthermore, it is preferable to bend at least a part of the tube by applying a force from the outside of the tube.

  Moreover, it is preferable to further include a step of applying a fluorine coating to the fine concavo-convex structure.

  According to the manufacturing method according to the present invention, it is possible to manufacture 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 detained the tracheal tube manufactured using the manufacturing method of the medical tube as one Embodiment of 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 the fine concavo-convex structure formed in the inner surface of the tube main body 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 of the direction perpendicular | vertical to the center axis direction of the tube main body shown in FIG. It is the figure which expanded a part of expanded view of the internal peripheral surface shown in FIG. FIG. 6A is a diagram showing a line and space structure, and FIG. 6B is a diagram showing a pillar structure. It is a figure which shows the formation flow of the medical tube as one Embodiment of this invention. It is a figure which shows the formation process of a medical tube. It is sectional drawing of the direction perpendicular | vertical to the central-axis direction of a core pin in the state which inserted the core pin which wound the 1st metal mold | die in the internal space of a 2nd metal mold | die. It is a figure which shows the example of the core pin which has an ejection hole in an outer peripheral surface. It is a figure which shows the example of the core pin which can switch the communication state and shielding state of an ejection hole.

  Hereinafter, an embodiment of a method for manufacturing a medical tube according to the present invention will be described with reference to FIGS. Here, the manufacturing method of the tube main body as a medical tube used for a tracheal tube is demonstrated as an example of the manufacturing method of the medical tube which concerns on this 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 for manufacturing a medical tube according to the present invention will be described. FIG. 1 is a view showing a state in which a tracheal tube 1 manufactured using a medical tube manufacturing method 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. FIG. 4 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, the cuff mounting portion 9 to which the cuff 3 is attached on the outer peripheral surface, the bending portion 10 continuous on the proximal end 6 side of the cuff mounting portion 9, and the bending portion 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, a fine concavo-convex structure 100 is formed on the entire inner surface of the tube main body 2 as a medical tube. The fine concavo-convex structure 100 has a surface on which unevenness of a size of several μm to hundreds of μm, preferably several μm to several tens of μm is formed. The fine concavo-convex structure 100 region has a property of suppressing wrinkle adhesion (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.

  A fluorine coat layer 200 is formed on the surface of the fine concavo-convex 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. In the state where 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 proximal end portion 11 (see FIG. 2) of the tube body 2. When the tube body 2 is inserted into the trachea from outside the body, the tracheal tube 1 is placed. The tip 8 is fixed at an appropriate position in the trachea by contacting the skin. As shown in FIGS. 1 and 4, the flange member 4 is a cylindrical tube that is fitted to the tube main body 2 when the proximal end portion 11 of the tube main body 2 is inserted and fitted to the tube main body 2. 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. 4, 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. 4, 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 proximal to the flange portion 18. , 17c. In the 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 have corresponding communication holes 17 a, 17 b, It communicates with the outside of the tracheal tube 1 via 17c, and a medical tube different from the tube body 2 is connected to each of the communication holes 17a, 17b, 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 19a 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 19 b 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 19c 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 or the like 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. As shown in FIG. 4, the suction tubes 19a and 19b and the cuff tube 19c 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 way, in the state where the tracheal tube 1 is placed in the trachea, the suction tubes 19a and 19b and the cuff tube 19c are prevented from colliding with the patient's jaw and neck, and the tracheal tube 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.

<Method for manufacturing tube body 2>
Next, the manufacturing method of the tube main body 2 as a medical tube is demonstrated. FIG. 5 shows a cross-sectional view in a direction perpendicular to the central axis direction A (see FIG. 2) of the tube main body 2 as a medical tube. 5 is a cross-sectional view at a position where all of the first lumen 12, the second lumen 13, and the third lumen 14 are present in the central axis direction A of the tube main body 2. FIG. This manufacturing method is a manufacturing method of the tube main body 2 as a medical tube which has the internal peripheral surface 31, as shown in FIG. A fine concavo-convex structure 100 as shown in FIG. 3 is formed on the inner peripheral surface 31.

  The example of the uneven | corrugated pattern of the fine uneven structure 100 formed in the internal peripheral surface 31 is shown. FIG. 6 is an enlarged view of a part of the developed view of the inner peripheral surface 31, in which the horizontal direction 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. As described above, the fine concavo-convex structure 100 is a concavo-convex structure having a size of several μm to hundreds of μm, preferably a size of several μm to several tens of μm. The uneven structure can take several uneven patterns. For example, as shown in FIG. 6A, a structure in which convex ribs 101 and concave grooves 102 extending in the central axis direction A of the tube body 2 are alternately arranged in the circumferential direction B (hereinafter simply referred to as “line”). And an "and-space structure"). Further, for example, as shown in FIG. 6B, a structure in which the truncated cone-shaped protrusions 103 are arranged in a predetermined arrangement (hereinafter simply referred to as “pillar structure”) can be employed. 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. It is preferable that the convex rib 101 and the concave groove 102 have a configuration shown in FIG. Further, the shape of the protrusion 103 constituting the pillar structure is not limited to the truncated cone shape, and may be a cone shape, a columnar shape, a triangular pyramid shape, other polygonal pyramid shapes, a prismatic shape, or the like.

  Note that, 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. The distance between the centers of the ribs 101 or the projections 103 in the pillar structure (hereinafter, the convex ribs 101 and the projections 103 are simply referred to as “convex portions”) is preferably 10 μm to 100 μm, and 10 μm to 50 μm. Is more 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, under the above conditions, the size of the fine concavo-convex structure 100 is set such that 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 of μm.

  FIG. 7 shows a flow of forming the tube body 2 as a medical tube. FIG. 8 shows a process for forming the tube body 2.

  In this manufacturing method, the step (P1) of winding the first mold 40 around the core pin 50 and the core pin 50 around which the first mold 40 is wound are inserted into the internal space 62 of the second mold 60. A step (P2) of filling the molding material 70 and molding the tube 80 (P3), a step of pulling out the core pin 50 (P4), and a step of peeling the first mold 40 from the tube 80 (P5). And a step of applying a fluorine coating to the surface of the fine concavo-convex structure 100 (P6). Here, the diagrams shown in FIGS. 8A to 8E correspond to the steps (P1) to (P5), respectively. Note that the tube 80 may be taken out from the internal space 62 of the second mold 60 at an arbitrary time after the step (P3).

  The tube 80 obtained through the above steps has the inner surface 81 on which the fine concavo-convex structure 100 is formed because the fine concavo-convex pattern 42 formed on the surface 41 of the first mold 40 is transferred to the inner surface 81. become. Therefore, the tube body 2 having the inner surface 81 on which the fine concavo-convex structure 100 is formed can be obtained by molding the tube body 2 using the tube 80. Hereinafter, the details of each of the steps will be described.

<Step of winding first mold 40 around core pin 50 (P1)>
First, the step (P1) of winding the first mold 40 around the core pin 50 will be described. As shown in FIG. 8A, the first mold 40 used in this step is a rectangular sheet-like member having a fine uneven pattern 42 on the surface 41 and having a long side and a short side. . The fine concavo-convex pattern 42 formed on the surface 41 of the first mold 40 has a concavo-convex direction opposite to that of the fine concavo-convex structure 100 formed on the inner peripheral surface 31 described above. The first mold 40 is flexible enough to be wound around the core pin 50. The first mold 40 preferably has a short side having a length substantially equal to the outer diameter of the core pin 50 in order to cover the circumferential direction of the core pin 50 without a gap when wound around the core pin 50. Further, it is preferable that the first mold 40 has a length whose long side is substantially equal to the axial direction of the core pin 50.

  The thickness of the 1st metal mold | die 40 is 0.2 mm or more, Among these, the thickness which the fine uneven | corrugated pattern 42 occupies is 30 micrometers-100 micrometers. Note that the thickness of the first mold 40 is smaller than the outer diameter of the core pin 50. The first metal mold 40 preferably has a higher melting point than the molding material 70 so as not to melt in the step (P3) of filling the molding material 70 and molding the tube 80. As a constituent material of the first mold 40, for example, a metal material such as stainless steel, a shape memory alloy such as nitinol, or a resin having a high melting point can be used. As the resin having a high melting point, a resin called a super engineering plastic can be used. For example, polyarylate (PAR), polysulfone (PSU), polyethersulfone (PES), polyamideimide (PAI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyether ether ketone (PEEK), liquid crystal polymer (PCP), polyimide (PI), fluororesin (PFA, EPA) and the like.

  As shown in FIG. 8A, the core pin 50 used in this step is continuous with a distal end portion 51 having a reduced diameter on the distal end side, a proximal end side of the distal end portion 51, a cylindrical main body portion 52, and a main body. A columnar base end portion 53 which is continuous on the base end side of the portion 52 and has a diameter larger than that of the main body portion 52. The core pin 50 has such rigidity and heat resistance that the shape change in each of the above steps can be ignored, and is made of, for example, metal. On the outer surface of the core pin 50, a recess or a protrusion may be formed along the axial direction or the circumferential direction.

  The first mold 40 is wound around the main body portion 52 of the core pin 50 so that the surface 41 having the fine concavo-convex pattern 42 is an outer surface.

<Step of inserting the core pin 50 around which the first mold 40 is wound into the internal space 62 of the second mold 60 (P2)>
Next, the process (P2) of inserting the core pin 50 around which the first mold 40 is wound into the internal space 62 of the second mold 60 will be described. The second mold 60 used in this step has such rigidity and heat resistance that the change in shape in each of the above steps can be ignored, and is made of metal, for example. As shown in FIG. 8B, the second mold 60 has an inner surface 61 that defines an internal space 62. The internal space 62 is cylindrical, and the internal diameter of the internal space 62 is larger than the external diameter of the core pin 50 around which the first mold 40 is wound. The core pin 50 around which the first mold 40 is wound is inserted into the internal space 62 from the front end side so that a gap 63 is formed between the inner pin 61 and the inner surface 61 of the second mold 60. As shown in FIG. 8C, the second mold 60 has an injection hole 64 communicating with the internal space 62 from the outside for injecting the molding material 70 into the internal space 62 from the outside.

  9 shows a core pin 50 in which the first mold 40 is wound so that a gap 63 is formed between the inner space 62 of the second mold 60 and the inner surface 61 of the second mold 60. 6 is a cross-sectional view in a direction perpendicular to the central axis direction of the core pin 50 in a state in which is inserted. As shown in FIG. 9, a cylindrical gap 63 is formed between the outer peripheral surface of the core pin 50 around which the first mold 40 is wound and the inner surface 61 of the second mold 60.

<Process of Filling Molding Material 70 and Molding Tube 80 (P3)>
Next, the process (P3) of filling the molding material 70 and molding the tube 80 will be described. As shown in FIG. 8C, the molding material 70 heated to a softening temperature is injected from the injection hole 64 by applying an injection pressure (usually about 10 to 3000 kgf / c), thereby allowing the internal space 62 to be injected. The molding material 70 is filled in the gap 63. Thereafter, the molding material 70 is solidified when the temperature is lowered, and the cylindrical tube 80 is molded. At this time, since the first die 40 wound around the core pin 50 has the surface 41 having the fine concavo-convex pattern 42 as the outer surface, the fine concavo-convex pattern 42 is transferred to the inner surface 81 of the molded tube 80. Thus, the fine uneven structure 100 is formed. In addition, as a constituent material of the molding material 70, the same material as the constituent material of the tube main body 2 can be used.

<Process of pulling out core pin 50 (P4)>
Next, the process (P4) which pulls out the core pin 50 is demonstrated. As shown in FIG. 8D, the core pin 50 is pulled out from the base end side while the first mold 40 is left in the tube 80. In order to detach the core pin 50 from the first mold 40 when the core pin 50 is pulled out, for example, as shown in FIG. 10, the core pin 50 has an ejection hole 54a through which a gas such as air can be ejected as shown in FIG. It is preferable to use 50a. The ejection hole 54 a included in the core pin 50 a is disposed in the distal end portion 51 and / or the main body portion 52. As for the magnitude | size of the ejection hole 54a, a diameter is 1 micrometer-50 micrometers, for example, Preferably they are 1 micrometer-10 micrometers. When unevenness is formed on the outer surface of the core pin 50a, the ejection hole 54a is preferably provided in the recess, and may be provided in the protrusion or both. FIG. 10 shows an example in which the ejection holes 54a are arranged at equal intervals along the axial direction of the core pin 50a. However, the present invention is not limited to such an arrangement, and the ejection holes 54a are arranged in the axial direction of the core pin 50a and / or Or it can arrange | position in the arbitrary positions of the circumferential direction. By using such a core pin 50a, a gas layer is formed between the outer surface of the core pin 50a and the inner surface of the first mold 40 when gas is ejected from the ejection hole 54a in this step. Therefore, the resistance at the time of pulling out the core pin a can be reduced.

  11A and 11B are diagrams showing another example of the core pin having the ejection hole. FIG. 11A is a cross-sectional view in the circumferential direction of the core pin 50b having the ejection hole 54b, and FIG. 11B has the ejection hole 54c. It is sectional drawing of the direction in alignment with the axial direction of the core pin 50c. The core pins 50b and 50c respectively have inner layers 55b and 55c having ejection holes 54b and 54c, and outer layers 56b and 56c having communication holes 57b and 57c and positioned radially outside the inner layers 55b and 55c. As shown in FIG. 11A, the inner hole 55b of the core pin 50b is provided with an ejection hole 54b along the circumferential direction, and the outer layer 56b of the core pin 50b is arranged in the circumferential direction as shown in FIG. 11A. A communication hole 57b is arranged along the line. Further, the inner layer 55b can be rotated along the circumferential direction with respect to the outer layer 56b. Thereby, the core pin 50b can switch between a communication state in which the ejection hole 54b communicates with the outside via the communication hole 57b and a shielding state in which the ejection hole 54b is shielded by the outer layer 56b. Further, as shown in FIG. 11B, the inner hole 55c of the core pin 50c is provided with an ejection hole 54c along the axial direction, and the outer layer 56c of the core pin 50c is arranged as shown in FIG. 11B. A communication hole 57c is arranged along the axial direction. The inner layer 55c can be moved along the axial direction with respect to the outer layer 56c. Thereby, the core pin 50c can switch between a communication state in which the ejection holes 54c communicate with the outside via the communication holes 57c and a shielding state in which the ejection holes 54c are shielded by the outer layer 56c. Therefore, by using these core pins 50b and 50c, in this process, gas can be ejected from the ejection holes 54b and 54c as a communicating state, and in other processes such as the process (P3), the shielding state can be achieved. Therefore, the resistance at the time of pulling out the core pins 50b and 50c can be reduced, and the possibility that foreign matter such as the molding material 70 flows into the core pins 50b and 50c through the communication holes 57b and 57c can be reduced. it can.

  In addition, it is good also as a structure which diameter-reduces a core pin in this process using the core pin which can be diameter-reduced as a core pin 50, for example by folding or changing. The core pins that can be reduced in diameter in the radial direction include a core pin that can be divided into a plurality of parts, an elastic member such as a self-expanding net-like cylindrical member or a spiral or spiral spring member, and a balloon that is expanded by air pressure or water pressure. And the like. Thereby, since the core pin can be detached from the first mold 40, the core pin can be pulled out while the first mold 40 is left in the tube 80.

<Step of removing first mold 40 from tube 80 (P5)>
Finally, the step (P5) of peeling the first mold 40 from the tube 80 will be described. In the step (P3), the first mold 40 is peeled from the inner surface 81 of the tube 80 while keeping the fine concavo-convex structure 100 formed on the inner surface 81 of the tube 80 from breaking. Thereby, as shown in FIG.8 (e), the tube 80 which has the inner surface 81 in which the fine concavo-convex structure 100 was formed is obtained.

<Step of applying fluorine coating to the surface of the fine concavo-convex structure 100 (P6)>
Next, a fluorine coating is applied to the surface of the fine concavo-convex structure 100 to form a fluorine coat layer 200 (see FIG. 3). This will be specifically described. First, the above-described fluorine coating agent containing the fluororesin is applied to the surface of the fine concavo-convex structure 100 of the tube 80 having the inner surface 81 on which the fine concavo-convex structure 100 is formed. As a method for applying the fluorine coating agent, for example, a dip coating method in which the tube 80 is immersed in a solvent containing the fluorine coating agent, or a solvent containing the fluorine coating agent is poured into the inner surface 81 to form the fine concavo-convex structure 100. Examples of the method include a method of spreading the entire region, a method of spraying the inner surface 81 with a spray, a method of applying the inner surface 81 using a scissors member, and the like. Next, the tube 80 is dried in a state where a solvent containing a fluorine coating agent is applied. Thereby, a solvent is removed and the film | membrane of a fluorine coating agent is formed. Subsequently, the fluorine coating agent is cured to form a bond with the inner surface 81. As an example of a mode of curing the fluorine coating agent, for example, the tube 80 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 81 of the tube 80 can be improved, and the strength of the fine concavo-convex structure 100 formed on the inner surface 81 can be increased. Can be improved. Therefore, it is possible to make it difficult to damage the fine concavo-convex structure 100 in a bending process or the like of the tube 80 described later. However, the step of applying the above-described fluorine coating may be performed after the tube 80 is bent.

  The tube main body 2 is obtained by processing the tube 80 obtained through the above steps. For example, at least a part of the tube 80 is bent by applying a force from the outside of the tube 80. In this way, the bending portion 10 of the tube body 2 can be formed. As a method of applying a force from the outside of the tube 80, for example, a mold having a receiving surface that can be maintained in a desired posture in which at least a part of the tube 80 is curved can be used.

  The method for manufacturing a medical tube according to the present invention is not limited to the specific method described in the above-described embodiment, and various modifications can be made without departing from the gist of the invention described in the claims. Is possible. 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 according to the present invention include (1) insertion or indwelling in the digestive organ orally or nasally, such as a gastric tube catheter, a nutrition catheter, or a tube feeding tube. Catheters; (2) Oxygen catheters, endotracheal tubes, intratracheal suction catheters, or other catheters that are orally or nasally inserted or placed in the airways or trachea; (3) urinary catheters, urinary catheters, urethral balloons Catheters inserted into or placed in the urethra or ureter such as a catheter or balloon; (4) catheters inserted or placed in various body cavities, organs, tissues such as suction catheters, drainage catheters, rectal catheters; (5) Infusion tube, IVH (abbreviation for intravenous hyperalimentation) catheter, thermodilu Catheters, angiographic catheters, vasodilator catheters, and catheters that are inserted or placed in or directly into blood vessels such as dilators or introducers; (6) medical artificials such as artificial trachea and artificial bronchi (7) Circuits for medical devices for extracorporeal circulation treatment (artificial lung, artificial heart, artificial kidney, etc.).

  According to various medical tubes manufactured by the manufacturing method according to the present invention, a wide range of biological substances or medical liquids can be prevented from adhering 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.

  In addition, for example, in the above-described embodiment, a sheet-like member is used as the first mold 40, but is not limited thereto, and for example, a belt-like member is spirally wound around a core pin. It is good also as a 1st metal mold | die. Moreover, as a 1st metal mold | die, a tube-shaped member may be used and it may externally fit to a core pin. In the present application, the external fitting to the core pin is one mode of winding around the core pin.

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

1: Tracheal tube 2: Tube body (medical tube)
3: Cuff 4: Flange member 5: Tube body distal end 6: Tube body proximal end 7: Tube body hollow portion 8: Tube body distal end portion 9: Tube body distal end portion 10: Tube body cuff mounting portion 10: Tube body curved portion 11 : Base end 12 of the tube body: First lumen 12a: First base end opening 13: Second lumen 13a: Second base end opening 14: Third lumen 14a: Third base end opening 14b: Communication port 17: Tube Portions 17a, 17b, 17c: Communication hole 18: Flange portions 19a, 19b: Suction tube 19c: Cuff tube 31: Inner circumferential surface 40: First mold 41: First mold surface 42: Fine irregularities Patterns 50, 50a, 50b, 50c: Core pin 51: Core pin distal end 52: Core pin main body 53: Core pin base ends 54a, 54b, 54c: Ejection holes 55b, 55c: Inner layer 56b 6c: outer layer 57b, 57c: communication hole 60: second mold 61: inner surface 62 of second mold 62: internal space 63: gap 64: injection hole 70: molding material 80: tube 81: inner surface 100 of tube: Fine concavo-convex structure 101: convex rib 102: concave groove 103: protrusion 105: top surface 200: fluorine coating layer

Claims (4)

A method for producing a medical tube having an inner peripheral surface on which a fine relief structure is formed,
A step of winding a sheet-shaped first mold having a fine concavo-convex pattern on a core pin so that the surface becomes an outer surface;
Inserting the core pin around which the first mold is wound so that a gap is formed between the inner surface of the second mold and the inner surface of the second mold;
Filling the gap with a molding material and molding a tube;
A step of pulling out the core pin;
A step of peeling the first mold from the tube, only including,
The core pin has an ejection hole on the outer surface through which gas can be ejected,
In the step of pulling out the core pin, gas is ejected from the ejection hole,
The core pin has an inner layer having the ejection holes, and an outer layer having a communication hole and positioned radially outward from the inner layer, and the communication state in which the ejection holes communicate with the outside through the communication holes; The manufacturing method of the medical tube which can switch the shielding state by which the said ejection hole is shielded by the said outer layer . The method for manufacturing a medical tube according to claim 1, wherein the first mold has a melting point higher than that of the molding material. The manufacturing method of the medical tube of Claim 1 or 2 which curves at least one part of the said tube by applying force from the exterior of the said tube. The manufacturing method of the medical tube as described in any one of Claim 1 to 3 which further includes the process of giving a fluorine coating to the said fine concavo-convex structure.

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