JP2017169662A - Method for manufacturing medical tube - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method for manufacturing a medical tube to which a biological material or medical liquid is less likely to adhere.SOLUTION: A method for manufacturing a medical tube having a micro concavo-convex structure on the inner surface includes an installation process for installing an inner tube and an outer tube in a mold in a state that the outer tube is located on the outside in an axial direction of the inner tube having the micro concavo-convex structure on the inner surface through an annular space, and a filling process for filling the annular space with a molding material.SELECTED DRAWING: Figure 9

Description

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

  Conventionally, it is possible to connect the outside of the body and the trachea directly to the patient who has difficulty in spontaneous breathing and difficult to discharge sputum by himself, to secure the airway and to suck in foreign matter such as breathing and sputum The tracheal tube is 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 examined, 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 this invention is to provide the manufacturing method of the medical tube which a biological substance or a medical fluid does not adhere easily.

  The manufacturing method of the medical tube as the first aspect of the present invention is a manufacturing method of a medical tube having a fine uneven structure on the inner surface, and is annular on the radially outer side of the inner tube having the fine uneven structure on the inner surface. An installation step of installing the inner tube and the outer tube in a mold in a state where the outer tube is located through the space, and a filling step of filling the annular space with a molding material are included.

  As one embodiment of the present invention, in the installation step, a small-diameter tube having an outer diameter smaller than the outer diameter of the inner tube is installed by extending in the axial direction of the inner tube in the annular space, In the filling step, it is preferable to fill the molding material around the small-diameter tube in the annular space.

  As one embodiment of the present invention, it is preferable that a plurality of the small-diameter tubes are installed in the circumferential direction of the inner tube.

  As one embodiment of the present invention, it is preferable that a convex portion or a concave portion is formed on at least one of the outer surface of the inner tube and the inner surface of the outer tube.

  As one embodiment of the present invention, the mold includes an internal mold and an external mold installed on a radially outer side of the internal mold. In the installation step, the inner tube is connected to the internal mold. It is preferable that the outer tube is fitted on the outer surface of the mold, and the outer tube is fitted on the inner surface of the outer mold.

  The manufacturing method of the medical tube as one embodiment of this invention further includes the removal process which removes the said metal mold | die after the said filling process, The said internal metal mold | die can be expanded and contracted radially. The expansion body is preferably in an expanded state in the filling step and in a contracted state in the removal step.

  The manufacturing method of the medical tube as one embodiment of this invention further includes the removal process which removes the said metal mold | die after the said filling process, and the said internal metal mold | die is a sheet-like metal mold | die, and the said on the outer surface. A rod-shaped core mold around which the sheet-shaped mold is wound, and in the removing step, after the core mold is removed from the sheet-shaped mold, the sheet-shaped mold is removed from the inner tube. It is preferable.

  It is preferable that the manufacturing method of the medical tube as one embodiment of this invention further includes the coating process which performs a fluorine coating on the surface of the said fine concavo-convex structure.

  The method for producing a medical tube as the second aspect of the present invention is a method for producing a medical tube having a fine concavo-convex structure on the inner surface, and the inner tube is installed on the outer surface of an internal mold having a fine concavo-convex pattern. And an installation step of installing the outer tube on the inner surface of the outer mold located on the radially outer side of the inner tube with the annular space sandwiched between the inner tube and a molding material in the annular space. Filling and transferring the fine concavo-convex pattern onto the inner surface of the inner tube by the pressure of the molding material.

  ADVANTAGE OF THE INVENTION According to this invention, the manufacturing method of the medical tube which a biological material or a medical fluid cannot adhere easily can be provided.

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 of 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 which shows the cross section orthogonal to the central axis direction of the tube main body shown in FIG. It is the figure which expanded a part of expanded view of the inner surface of the tube main body 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 flowchart which shows the manufacturing method of the medical tube as one Embodiment of this invention. It is a figure which shows the outline | summary of the installation process shown in FIG. It is a figure which shows the outline | summary of the filling process shown in FIG. It is a figure which shows the outline | summary of the removal process shown in FIG. It is a figure which shows the modification of the internal metal mold | die shown in FIGS. It is a figure which shows the modification of the internal metal mold | die shown in FIGS. It is the expanded sectional view which expanded a part of cross section of the inner side tube simple substance shown in FIG. It is a flowchart which shows an example of the manufacturing method of an inner side tube. It is a figure which shows an example of the sheet | seat member acquisition process shown in FIG. It is a figure which shows an example of the bending process and joining process which are shown in FIG. It is sectional drawing which shows an example of the metal mold | die which can shape | mold an inner tube. It is a flowchart which shows the manufacturing method of the medical tube as one Embodiment of this invention. It is a figure which shows the outline | summary of the filling transfer process shown in FIG. It is a flowchart which shows the manufacturing method of the medical tube as one Embodiment of this invention.

  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.

  First, an example of 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 as an example of a tracheal tube manufactured using the method for manufacturing a medical tube 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 a part of a cross-sectional view of the tube main body 2 shown in FIG. 2, and is a view showing 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, the 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, 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 irregularities having a size of several μm to several hundreds of μm, preferably several μm to several tens of μm are 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. 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 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 a 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.

  Next, further details of the tube body 2 will be described.

  FIG. 5 is a cross-sectional view showing a cross section of the tube body 2 perpendicular to the central axis direction A. As shown in FIG. More specifically, FIG. 5 is a cross-sectional view of the tube body 2 at a position where the first lumen 12, the second lumen 13, and the third lumen 14 are all present in the central axis direction A.

  As shown in FIG. 5, the tube body 2 is composed of a plurality of layers stacked in the radial direction. Specifically, the tube main body 2 of the present embodiment includes an inner layer 21 constituting the inner surface 60 of the tube main body 2 on which the above-described fine concavo-convex structure 100 (see FIG. 3) is formed, and an outer layer constituting the outer surface of the tube main body 2. 23, and an intermediate layer 22 positioned between the inner layer 21 and the outer layer 23.

  Here, the “inner layer of the tube body” means a layer formed by the inner tube used at the time of forming the tube body, and when the inner tube itself is a single layer, the inner layer of the tube body. Will be even more. Further, when the inner tube itself has a plurality of layers, the inner layer of the tube body also has a plurality of layers. In the present embodiment, since the inner tube 31 whose details will be described later is a single layer, the inner layer 21 of the tube body 2 is also a single layer.

  The “outer layer of the tube body” means a layer formed by the outer tube used when the tube body is formed. When the outer tube itself is a single layer, the outer layer of the tube body is also It becomes one layer. Further, when the outer tube itself has a plurality of layers, the outer layer of the tube body also has a plurality of layers. In this embodiment, since the outer tube 32 whose details will be described later is a single layer, the outer layer 23 of the tube body 2 is also a single layer.

  Furthermore, the “intermediate layer of the tube main body” means a layer located between the inner layer of the tube main body and the outer layer of the tube main body, and is formed by a molding material filled between the inner tube and the outer tube. One layer (single layer) is formed.

  Therefore, the tube body 2 of the present embodiment has a three-layer structure in which one inner layer 21, one intermediate layer 22, and one outer layer 23 are stacked in this order from the radially inner side.

  Next, an example of the concavo-convex pattern of the fine concavo-convex structure 100 formed on the inner surface 60 of the tube body 2, that is, the inner surface 60 of the inner layer 21 is shown. FIG. 6 is an enlarged view of a part of the development of the inner peripheral surface of the tube main body 2, in which the horizontal direction indicates the central axis direction A of the tube main body 2 and the vertical direction indicates the circumferential direction B of the tube main body 2. Indicates. 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 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. In addition, 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 set to 1 μm to 30 μm, more 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 ribs. Become.

  Furthermore, under the above conditions, the size of the fine concavo-convex structure 100 is 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.

  Next, the manufacturing method of the tube main body 2 as a medical tube is demonstrated.

  FIG. 7 is a flowchart showing an example of a method for manufacturing the tube main body 2 as a medical tube. As shown in FIG. 7, the manufacturing method of the tube main body 2 of the present embodiment includes an inner tube 31 (see FIG. 5) that forms the inner surface 60 of the tube main body 2 and an outer tube 32 (that forms the outer surface of the tube main body 2). 5) is installed in the mold 70 in a state where the outer tube 32 is located on the radially outer side of the inner tube 31 via the annular space 33, and the molding material 80 (see FIG. 5) in the annular space 33. A filling step S2 for filling a reference) and a removing step S3 for removing the mold 70. Hereinafter, the detail of each process S1-S3 is demonstrated.

  FIG. 8 is a diagram showing an outline of the installation step S1. The mold 70 includes a columnar or cylindrical internal mold 70a, and an external mold 70b that is installed outside the internal mold 70a in the radial direction with a space therebetween. . As shown in FIG. 8A, in the installation step S1, the inner tube 31 having the fine uneven structure 100 on the inner surface is installed on the outer surface of the inner mold 70a. In other words, the inner tube 31 is fitted on the outer surface of the inner mold 70a, and the inner tube 31 is held on the outer surface of the inner mold 70a.

  Further, as shown in FIG. 8B, the external mold 70b defines a cylindrical internal space S whose one end is closed, and in the installation step S1, the outer tube 32 is disposed inside the external mold 70b. It is installed on the inner surface that divides the space S. In other words, the outer tube 32 is fitted on the inner surface that defines the inner space S of the outer mold 70b, and is held on the inner surface of the outer mold 70b. In addition, the process of fitting the outer tube 32 shown in FIG. 8B into the external mold 70b at the same time as or before the process of fitting the inner tube 31 shown in FIG. 8A into the inner mold 70a. You may go.

  Further, as shown in FIG. 8C, in the installation step S1, the inner mold 70a that holds the inner tube 31 on the outer surface is in the inner space S of the outer mold 70b that holds the outer tube 32 on the inner surface. More specifically, it is inserted into the outer tube 32 held on the inner surface of the external mold 70b. Thereby, an annular space 33 is formed between the inner tube 31 and the outer tube 32 in the inner space S.

  Thus, in the installation step S1, the inner tube 31 and the outer tube 32 are installed in the mold 70 in a state where the annular space 33 is formed.

  FIG. 8D is a cross-sectional view showing a state where the small diameter tubes 34 a, 34 b, 34 c are installed in the annular space 33. The cross section shown in FIG. 8D is a cross section orthogonal to the axial direction of the inner tube 31, the outer tube 32, and the small diameter tubes 34a to 34c. As shown in FIG. 8D, in the installation step S <b> 1 of the present embodiment, the thin tubes 34 a, 34 b, 34 c having an outer diameter smaller than the outer diameter of the inner tube 31 are replaced with the inner tube 31 in the annular space 33. Install in the axial direction. If it does in this way, the lumen in the wall of tube body 2 can be formed easily. Further, as shown in FIG. 8D, in this embodiment, a plurality of (three in the example of FIG. 8D) small-diameter tubes 34a, 34b, and 34c are arranged in the circumferential direction of the inner tube 31. ing. In this way, a plurality of lumens (the first lumen 12, the second lumen 13, and the third lumen 14 in the tube body 2) provided at different positions in the circumferential direction B of the tube body 2 can be easily formed. . However, the number of small diameter tubes and the installation position of the small diameter tubes in the circumferential direction of the inner tube 31 are not limited to the configuration shown in FIG. 8D, and can be changed as appropriate according to the design of the tube body. is there. In addition, when a lumen is not required in the wall of the tube body, it is not necessary to install a small diameter tube.

  FIG. 9 is a diagram showing an outline of the filling step S2. As shown in FIG. 9, in the filling step S2, the molding material 80 of the tube body 2 is filled into the annular space 33 formed in the above-described installation step S1. More specifically, as shown in FIG. 9, a molding material 80 heated to a softening temperature is injected by applying a predetermined injection pressure (usually about 10 to 3000 kgf / c), so that the inside of the internal space S is injected. The molding material 80 is filled in the annular space 33. The filled molding material 80 is integrated with the inner tube 31 and the outer tube 32.

  In the present embodiment, since the small diameter tubes 34a, 34b, and 34c (see FIG. 8D) are installed in the annular space 33, the periphery of the small diameter tubes 34a, 34b, and 34c in the annular space 33 is provided. Is filled with a molding material 80. Therefore, in addition to the inner tube 31 and the outer tube 32, the filled molding material 80 is integrated with the small diameter tubes 34a, 34b, and 34c.

  Thereafter, the molding material 80 solidifies as the temperature decreases. Thereby, the cylindrical tube material used as the original form of the tube main body 2 is shape | molded by the inner side tube 31, the outer side tube 32, the small diameter tubes 34a-34c, and the solidified molding material 80. FIG.

  In addition, as a constituent material of the inner tube 31, the outer tube 32, the small diameter tubes 34a to 34c, and the molding material 80, for example, those listed as the constituent materials of the tube main body 2 such as soft polyvinyl chloride can be used. .

  FIG. 10 is a diagram showing an outline of the mold 70 removal step S3. After the molding material 80 is solidified, the mold 70 is removed from the tube material in order to take out the molded tube material. First, as shown to Fig.10 (a), the external metal mold | die 70b which covers the circumference | surroundings of a tube material is removed. Since the external mold 70b shown in the present embodiment is a split mold composed of a first external mold 70b1 and a second external mold 70b2, the external mold 70b is divided into two and the internal mold 70a is inserted. Take out the tube material.

  Next, as shown in FIG. 10B, the internal mold 70a is pulled out from the molded tube material (see the arrow in FIG. 10B). Thereby, the tube material used as the original form of the tube main body 2 can be taken out.

  The inner surface of the molded tube material is the inner surface of the inner tube 31, and a fine uneven structure 100 (see FIG. 6 and the like) is formed. Therefore, if the internal mold 70a is forcibly pulled out from the molded tube material, the fine concavo-convex structure 100 may be damaged. FIG. 11 is a view showing an internal mold 170a as a modification of the internal mold 70a.

  The internal mold 170a shown in FIG. 11 is an expansion body that can be expanded and contracted in the radial direction. The internal mold 170a is expanded in the above-described filling step S2, and is contracted in the removal step S3. Is. When such an internal mold 170a is used, it is possible to prevent the internal mold 170a from damaging the fine concavo-convex structure 100 on the inner surface of the tube material when the internal mold 170a is pulled out from the molded tube material. In addition, when using such an internal metal mold | die 170a, when inserting the internal metal mold | die 170a in the inner side tube 31 by the installation process S1 mentioned above, it is preferable to make the internal metal mold | die 170a into a contracted state. If it does in this way, it can also suppress that the fine grooving | roughness structure 100 currently formed in the inner surface of the inner side tube 31 is damaged in installation process S1.

  Note that the expansion body as the internal mold 170a defines an internal space 171 as shown in FIG. 11, for example, and is expanded (see thick arrows in FIG. 11) and contracted by supplying and discharging a fluid such as gas or liquid (see FIG. 11). 11 can be used. However, the expansion body as the internal mold 170a is not limited to a balloon that can be expanded and contracted. For example, the expansion body may be an elastic member such as a self-expanding net-like cylindrical member or a spiral or spiral spring member. Good.

  Further, FIG. 12 is a view showing an internal mold 270a as another modified example of the internal mold 70a. An internal mold 270a shown in FIG. 12 includes a sheet-shaped mold 271 and a rod-shaped core mold 272 around which the sheet-shaped mold 271 is wound. The sheet-shaped mold 271 is a cylindrical sheet-shaped member having flexibility, and is externally fitted to a columnar or cylindrical core mold 272. The thickness of the sheet mold 271 is smaller than the outer diameter of the core mold 272. Moreover, it is preferable that the sheet-like mold 271 is formed of a material having a higher melting point than the molding material 80 so as not to melt in the filling step S <b> 2 in which the molding material 80 is filled. As a constituent material of the sheet-like mold 271, for example, a metal material such as stainless steel 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.

  Further, the core mold 272 has rigidity and heat resistance such that a change in shape can be ignored in the installation step S1 and the filling step S2 described above, and is made of, for example, metal. Grooves or ribs may be formed on the outer surface of the core mold 272 along the axial direction or the circumferential direction. When such grooves or ribs are present, the contact area with the inner surface of the sheet-like mold 271 is reduced at the time of insertion into and removal from the sheet-like mold 271 as compared with a configuration having no grooves or ribs. can do. Thereby, the insertion resistance and the extraction resistance between the outer surface of the core mold 272 and the inner surface of the sheet-like mold 271 can be reduced.

  If such an internal mold 270a is used, in the removal step S3, first, after removing the core mold 272 from the sheet mold 271, the inner mold 31 is folded or deformed, for example, by folding or deforming the sheet mold 271. It can be removed from the inner tube 31 by peeling from the inner tube 31. That is, the part (sheet mold 271) in contact with the fine concavo-convex structure 100 on the inner surface of the molded tube material of the inner mold 270a can be peeled off without being brought into sliding contact with the fine concavo-convex structure 100. . Therefore, it is possible to make it difficult to damage the fine concavo-convex structure 100 on the inner surface of the formed tube material, as compared with the case of using an internal mold that is pulled out while being in sliding contact with the fine concavo-convex structure 100.

  As described above, it is preferable to use the internal mold 170a shown in FIG. 11 or the internal mold 270a shown in FIG. 12 instead of the internal mold 70a shown in the present embodiment.

  In the present embodiment, the molding material 80 filled in the annular space 33 in the filling step S <b> 2 contacts the outer surface of the inner tube 31 and the inner surface of the outer tube 32, and is integrated with the inner tube 31 and the outer tube 32. In order to improve the fixing property between the inner tube 31 and the outer tube 32 and the molding material 80, it is preferable that a convex portion or a concave portion is formed on at least one of the outer surface of the inner tube 31 and the inner surface of the outer tube 32. . FIG. 13 is a diagram showing a plurality of convex portions 104 provided along the circumferential direction on the outer surface of the inner tube 31, and shows a cross section of the inner tube 31 orthogonal to the axial direction. The convex portion 104 may be a cone-shaped, frustum-shaped, or columnar projection, or may be a convex rib in a line-and-space structure in which convex ribs and concave grooves are repeatedly arranged. As shown in FIG. 13, the height T <b> 1 of the convex portion 104 needs to be high enough to secure the fixing property with the molding material 80, and therefore, the convex portion of the fine concavo-convex structure 100 provided on the inner surface of the inner tube 31 ( (Refer to the convex rib 101 in Fig. 6A and the projection 103 in Fig. 6B) It is preferably higher than the height T2. The height T1 of the convex portion 104, or in addition to or in place of the convex portion 104 The depth of the recessed portion provided can be, for example, about 500 μm to 1000 μm, and the inner surface of the inner tube 31 also has a pitch W1 between the convex portions 104 adjacent in the circumferential direction, as shown in FIG. It is preferable to make it larger than the pitch W2 in the circumferential direction of the convex portions of the fine concavo-convex structure 100 provided on the inner surface of the inner tube 31 and the molding material. It is possible to improve the fixability to 80. The pitch W1 of the convex portions 104 is preferably 100 μm or more, more preferably 500 μm or more, and particularly preferably 1000 μm or more. The convex portions 104 provided on the outer surface of the tube 31 and the inner surface of the outer tube 32 may be formed by increasing the surface roughness of the outer surface of the inner tube 31 and the inner surface of the outer tube 32.

  The tube material used as the original form of the tube main body 2 can be shape | molded by the above method, and the tube main body 2 as a medical tube is obtained by performing the process which cuts the both ends of this tube material, finishing processing, etc. Can do. In addition, in this embodiment, although the tubular body taken out by the removal process S3 (refer FIG. 7 etc.) mentioned above is called the tube material used as the original form of the tube main body 2, it was taken out by the removal process S3 mentioned above. The tube body itself can be used as another medical tube different from the tube body 2 such as a tube body having a shape different from that of the tube body 2. That is, the tube itself taken out by the above-described removal step S3 may be used as a medical tube.

  Here, a manufacturing method of the inner tube 31 that forms the inner layer 21 (see FIG. 5) of the tube body 2 and forms the inner surface 60 (see FIG. 5) of the tube body 2 will be described. As described above, the inner tube 31 has an inner surface on which the fine concavo-convex structure 100 is formed, and can be manufactured by a manufacturing method illustrated below.

  FIG. 14 is a flowchart showing an example of a method for manufacturing the inner tube 31. 15 and 16 are diagrams showing an outline of each process shown in FIG. As shown in FIGS. 14 to 16, the inner tube 31 is formed with a fine concavo-convex structure 100 (see FIGS. 3 and 6) on one surface of a sheet-like material, and the fine concavo-convex structure 100 is formed on one surface. A sheet member acquisition step P1 for acquiring the sheet member 50 included in the sheet, a bending step P2 for bending the sheet member 50 into a cylindrical shape so that one surface on which the fine concavo-convex structure 100 is formed becomes an inner surface, and And a joining process P3 for joining both ends of the sheet member 50. Details of each step will be described below.

  In the sheet member acquisition step P1, the sheet member 50 is formed from a flexible sheet-like material having a thickness of 0.1 mm to 1.0 mm, more preferably a thickness of 0.15 mm to 0.5 mm. As the sheet-like material, for example, the constituent material of the tube main body 2 described above such as soft polyvinyl chloride can be used.

  FIG. 15 is a diagram illustrating an example of the sheet member acquisition process P1. As shown in FIG. 15, the fine concavo-convex structure 100 of the sheet member 50 has a sheet-like shape that is the original form of the sheet member 50 by using a press die 51 in which a fine concavo-convex pattern 52 obtained by inverting the fine concavo-convex structure 100 is formed in advance. It is formed by being pressed against one surface of the material and transferring the fine uneven pattern 52. More specifically, as shown to Fig.15 (a), the press metal mold | die 51 is pressed against any one surface 53 of a sheet-like material (refer the white arrow of Fig.15 (a)). As described above, the fine concavo-convex pattern 52 is formed on the surface of the press die 51 that is pressed against the sheet-like material. As shown in FIG. 15B, heating is performed in a state where the press mold 51 is pressed against the sheet-like material (see the white arrow in FIG. 15B). By doing so, the fine concavo-convex pattern 52 of the press mold 51 is transferred to one surface 53 of the sheet-like material, and the direction of the concavo-convex is opposite to the fine concavo-convex pattern 52 as shown in FIG. The sheet member 50 having the fine concavo-convex structure 100 on the one surface 53 can be formed.

  FIG. 16 is a diagram illustrating an example of the bending process P2 and the joining process P3. As shown in FIG. 16A, in the bending step P2, the sheet member 50 is bent into a cylindrical shape so that the surface 53 on which the fine uneven structure 100 (see FIG. 15) is formed becomes the inner surface. When bending the sheet member 50, as shown in FIG. 16A, the sheet member 50 may be bent into a cylindrical shape by winding it around the outer peripheral surface of a cylindrical or cylindrical cylindrical forming jig 54. The sheet member 50 can be bent into a cylindrical shape without using the jig 54. Specific examples of the cylindrical forming jig 54 include a metal bar and a resin bar. Other specific examples of the cylindrical forming jig 54 include expansion members such as a self-expanding reticulated cylindrical member, an elastic member such as a spiral or spiral spring member, a balloon that expands by air pressure or water pressure, and the like.

  Next, in the joining step P3, both end portions 55a and 55b of the sheet member 50 bent into a cylindrical shape are joined. Specifically, in the joining step P3, as shown in FIG. 16 (b), the end surfaces of both end portions 55a and 55b of the sheet member 50 are butted together, and the butted portion is heated or the like (a wavy arrow in FIG. 16 (b)). To be welded. Thereby, the inner side tube 31 (refer FIG. 8 etc.) can be obtained. The end surfaces of both end portions 55a and 55b can be welded together by using, for example, laser, electricity, high frequency, ultrasonic waves, or the like. In addition, joining of both ends 55a and 55b is not limited to joining by welding, and various joining techniques can be used. Therefore, for example, bonding by using an instantaneous adhesive or a UV curable adhesive may be used.

  Note that the joining of both end portions 55a and 55b of the cylindrically bent sheet member 50 in the joining step P3 may be performed in a state in which the cylindrical forming jig 54 is inserted as shown in FIG. . In such a case, a part or all of the cylindrical forming jig 54 is made of a material having good thermal conductivity, and the cylindrical forming jig 54 is heated or heated from the outside, whereby the cylindrical forming jig 54 is passed through the cylindrical forming jig 54. It is also possible to heat both ends 55a and 55b of the sheet member 50 wound around and weld both ends 55a and 55b. As a material having good thermal conductivity, for example, a metal such as aluminum or copper can be used.

  In addition, in the joining step P3, the sheet member 50 bent in a cylindrical shape so that the end surfaces of the both end portions 55a and 55b that face each other are not displaced regardless of whether or not the cylindrical forming jig 54 is inserted. The both end portions 55 a and 55 b of the sheet member 50 may be welded in a state where the outer peripheral surface of the sheet member 50 is fixed by the holding member 56. As the holding member 56, for example, a member having a C-shaped cross section as shown in FIG. By positioning both end portions 55a and 55b of the sheet member 50 in the gap portion of the holding member 56 having a C-shaped cross section, both end portions 55a and 55b of the sheet member 50 are heated from the outside or the inside, and both end portions 55a and 55b are heated. 55b can be welded. Further, instead of the cylindrical forming jig 54 described above, another member is inserted into the inside of the sheet member 50 bent into a cylindrical shape, and this member is heated or heated from the outside, whereby both end portions of the sheet member 50 are obtained. 55a and 55b may be heated to weld both end portions 55a and 55b.

  In the example shown in FIG. 16, the end surfaces of both end portions 55 a and 55 b of the sheet member 50 are butted against each other and are not limited to this joining method. For example, both end portions 55 a and You may join by welding etc. in the state which accumulated 55b double.

  As described above, the inner tube 31 shown in FIG. 8 and the like can be formed through the steps shown in FIGS.

  However, the manufacturing method of the inner tube 31 is not limited to the method described above. For example, the inner tube 31 may be obtained by molding a tube material having the fine concavo-convex structure 100 formed on the outer surface by injection molding or the like, and turning the outer surface and the inner surface upside down. Further, when the flexible inner tube 31 is formed with a thin wall (for example, 0.1 mm to 1.0 mm), the inner side having the fine concavo-convex structure 100 on the inner surface directly, i.e., without the need to turn it over. The tube 31 can also be formed. FIG. 17 is a cross-sectional view of a mold 57 capable of directly forming the inner tube 31 having the fine relief structure 100 on the inner surface. A mold 57 shown in FIG. 17 has an inner mold 57a on the outer surface of which a fine concavo-convex pattern 93 obtained by inverting the fine concavo-convex structure 100 is formed, as in the case of the fine concavo-convex pattern 52 (see FIG. 15). A mold 57b. A cavity 58 between the inner mold 57a and the outer mold 57b is filled with a molding material. After the filling material is solidified, for example, the split outer mold 57b is removed.

  Next, the inner mold 57a is pulled out from the inner tube 31 formed by solidifying the filling material. Here, an ejection hole 59 is defined on the outer surface of the internal mold 57a, and a gas such as air, nitrogen, or a liquid such as water can be ejected through the ejection hole 59. Therefore, a fluid such as compressed gas or liquid is ejected from the ejection hole 59, the inner tube 31 is expanded by the pressure of the fluid, and the internal mold 57a is pulled out. In this way, the inner tube 31 is not damaged by the fine uneven pattern 93 on the outer surface of the internal mold 57a, in other words, while maintaining the pattern of the formed fine uneven structure 100, the inner tube The internal mold 57 a can be pulled out from 31. In this way, the inner tube 31 may be formed without performing the work of turning the outer surface and the inner surface upside down.

  In addition, about the outer side tube 32, since it does not have a fine uneven structure in an inner surface and an outer surface, a manufacturing method is not specifically limited. Therefore, for example, by using injection molding, extrusion molding, or the like, it is possible to perform molding by a manufacturing method similar to the conventional one. However, you may use the method similar to the manufacturing method of the inner side tube 31 mentioned above.

  Finally, as a method for manufacturing the tube body 2 as a medical tube, a method different from the above-described manufacturing method will be described with reference to FIGS. 18 and 19. FIG. 18 is a flowchart showing a method of manufacturing the tube body 2 as a medical tube described here. FIG. 19 is a diagram showing an outline of the filling transfer process in FIG. The manufacturing method of the tube main body 2 shown in FIG.18 and FIG.19 installs inner tube 31 'on the outer surface of internal metal mold | die 70a' which has the fine uneven | corrugated pattern 94, and is located in the radial direction outer side of inner tube 31 '. On the inner surface of the outer mold 70b, an installation step R1 for installing the outer tube 32 with the annular space 33 sandwiched between the inner tube 31 'and the annular space 33 is filled with the molding material 80. This includes a filling and transferring step R2 for transferring the fine uneven pattern 94 to the inner surface of the inner tube 31 ′ by the pressure and a removing step R3 for removing the die 70 ′ including the inner die 70a ′ and the outer die 70b.

  The manufacturing method of the tube main body 2 shown in FIGS. 18 and 19 is different from the above-described manufacturing method of the tube main body 2 described with reference to FIG. The fine concavo-convex structure 100 is formed on the inner surface of the tube material. More specifically, the manufacturing method of the tube main body 2 shown in FIGS. 18 and 19 includes the internal mold 70a and the inner tube 31 used in the above-described manufacturing method of the tube main body 2 described with reference to FIG. After changing to the internal mold 70a ′ and the inner tube 31 ′, the same procedure as the above-described method for manufacturing the tube body 2 described with reference to FIG. 7 and the like is performed. That is, the manufacturing method of the tube main body 2 shown in FIGS. 18 and 19 is the same as the manufacturing method of the tube main body 2 described above with reference to FIG. 7 and the like except that the inner mold and the inner tube to be used are different. Therefore, the description is omitted here, and only the difference in configuration between the inner mold and the inner tube will be described.

  The inner mold 70a of the mold 70 described above does not have a fine uneven pattern on the outer surface and the outer surface is a smooth outer peripheral surface, whereas the inner mold 70a of the mold 70 'shown in FIG. 'Has a fine uneven pattern 94 on the outer surface. Here, the fine concavo-convex pattern 94 is obtained by inverting the fine concavo-convex structure 100 of the tube body 2. Further, the inner tube 31 described above has the fine uneven structure 100 on the inner surface, whereas the inner tube 31 ′ shown in FIG. 19 does not have the fine uneven structure on the inner surface. The inner surface is a smooth outer peripheral surface. By using such an internal mold 70a 'and the inner tube 31', the fine concavo-convex structure 100 can be transferred to the inner surface of the inner tube 31 'by filling the annular space 33 with the molding material 80 (filling). Transfer step R2).

  When the manufacturing method shown in FIGS. 18 and 19 is adopted, the inner tube 31 ′ is configured such that the fine concavo-convex structure 100 is easily formed by pressing the fine concavo-convex pattern 94 of the internal mold 70 a ′. It is preferable. On the other hand, since the outer tube 32 forms the outer surface of the tube body 2, it is preferable to have a predetermined hardness. Therefore, for example, the hardness of the inner tube 31 ′ is preferably smaller than the hardness of the outer tube 32. Such a hardness relationship can be realized by various configurations, and for example, may be realized by using different constituent materials, or may be realized by making the thicknesses different using the same constituent materials.

  Note that the internal mold 70a 'can be formed of an expanded body like the above-described internal mold 170a (see FIG. 11). Further, the internal mold 70a ′ is composed of a sheet-shaped mold and a rod-shaped core mold in which the sheet-shaped mold is wound on the outer surface as in the above-described internal mold 270a (see FIG. 12). It is also possible to configure. When the internal mold 70a ′ is configured by a sheet mold and a core mold, the fine uneven pattern 94 may be provided on the outer surface of the sheet mold.

  In addition, the manufacturing method of the tube main body 2 as a medical tube demonstrated with reference to FIGS. 1-19 is the curve which curves the tube material used as the original form of the tube main body 2 in addition to the various processes mentioned above, for example. A process may be included. The bending step can be performed, for example, after the removal step S3 (see FIG. 7 and the like) and R3 (see FIG. 18 and the like). In the bending step, the core rod member that is at least partially curved is inserted into the tube material that has been removed from the mold in the removal steps S3 and R3. Thereby, the tube material can be curved along the core rod member. And it heats and cools with the curved state. By doing in this way, a tube material can be brazed in the predetermined curved shape, and the curved part 10 (refer FIG. 2) of the tube main body 2 can be formed.

  Further, as another example of the bending step, a core rod member that is linear and deformable by applying an external force is inserted into the tube material removed from the mold by the removal steps S3 and R3. It may be. That is, a straight core rod member is inserted into the tube material, the core rod member is curved after insertion, and then a mold having a receiving surface capable of maintaining the curved tube material in a desired posture is used. The curved state is fixed from the outside. In this way, the curved portion may be formed in the tube material. The bendable core rod member may be formed from a flexible silicone resin, a shape memory alloy, or the like.

  Furthermore, the manufacturing method of the tube main body 2 as a medical tube described with reference to FIGS. 1 to 19 includes the fine concavo-convex structure 100 formed on the inner surface of the inner tube 31 in addition to the various processes described above. It may further include a coating process in which a fluorine coating is applied to the surface to form a fluorine coat layer 200 (see FIG. 3). 20 shows a manufacturing method of the tube body 2 when the coating step S0 for applying a fluorine coating to the surface of the fine concavo-convex structure 100 formed on the inner surface of the inner tube 31 is performed before the installation step S1 shown in FIG. It is a flowchart which shows. In addition, since the installation process S1, the filling process S2, and the removal process S3 shown in FIG. 20 are the same as those described above, the description is omitted here, and the coating process S0 will be described.

  In the coating step S0, the surface of the fine concavo-convex structure 100 formed on the inner surface of the inner tube 31 is coated with fluorine to form a fluorine coating layer 200 (see FIG. 3). Specifically, the fluorine coating agent containing the above-described fluororesin is applied to the surface of the fine concavo-convex structure 100. As a method for applying the fluorine coating agent, a dip coating method in which the inner tube 31 is immersed in a solvent containing the fluorine coating agent, or a solvent containing the fluorine coating agent is poured into the inner tube 31 to form the fine uneven structure 100. Various methods such as a method of spreading over the entire region where the film is formed, a method of spraying with a spray, and a method of spreading over the surface of the fine concavo-convex structure 100 using a gutter member can be used. Next, the inner tube 31 is dried in a state where a solvent containing a 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 fine concavo-convex structure 100. As an example of an aspect of curing the fluorine coating agent, for example, the inner tube 31 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 and forming the fluorine coat layer 200, the water repellency, oil repellency and friction resistance of the inner surface of the inner tube 31 can be improved and the inner surface is formed on the inner surface. The strength of the fine relief structure 100 can be improved. Therefore, the fine concavo-convex structure 100 can be made difficult to be damaged during the installation step S1, the filling step S2, and the removal step S3.

  The coating step S0 may be performed after the removing step S3. Moreover, you may make it perform the same coating process after the removal process R3 in the manufacturing method of the tube main body 2 shown in FIG. Furthermore, as shown in FIGS. 14 to 16, when the inner tube 31 is formed from the sheet member 50, it is after the sheet member acquisition step P1 and before the bending step P2 for bending the sheet member 50 into a cylindrical shape. Furthermore, it is preferable to perform the same coating process as described above on the surface of the sheet member 50 on which the fine concavo-convex structure 100 is formed. In this way, since the strength of the fine concavo-convex structure 100 is improved, the fine concavo-convex structure 100 can be hardly damaged even in the bending step P2 of bending the sheet member 50 into a cylindrical shape.

  As mentioned above, if the manufacturing method of the tube main body 2 as a medical tube includes the above-mentioned coating process, the fluorine coat layer 200 (FIG. 3) is formed on the surface of the fine concavo-convex structure 100 on the inner surface 60 of the tube main body 2. Reference) can be formed.

  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 respiratory tract or trachea; (3) urinary catheters, urinary catheters, urethral balloons (4) Catheters inserted or placed in various body cavities, organs, tissues such as suction catheter, drainage catheter, rectal catheter; (5) Infusion tube, IVH (abbreviation for intravenous hyperalimentation) catheter, thermodilu Catheters, angiographic catheters, vasodilator catheters and catheters that are inserted or placed indirectly 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.

  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 21: Inner layer 22: Intermediate layer 23: Outer layer 31, 31 ': Inner tube 32: Outer tube 33: Annular space 34a, 34b, 34c: Small diameter tube 50: Sheet member 51: Press die 52: Fine uneven pattern 53: One surface 54 of sheet-like material: Cylindrical forming jig 55a, 5b: Sheet material end portion 56: Holding member 57: Mold 57a: Internal mold 57b: External mold 58: Cavity 59: Injection hole 60: Inner surface 70, 70 'of the tube body: Mold 70a, 70a ': Internal mold 70b: External mold 70b1: First external mold 70b2: Second external mold 80: Molding material 93, 94: Fine uneven pattern 100: Fine uneven structure 101: Convex rib (convex part)
102: Groove 103: Projection (convex part)
104: convex portion 105: top surface 170a: internal mold 171: internal space 200: fluorine coating layer 270a: internal mold 271: sheet mold 272: core mold A: central axis direction B of tube main body B: tube main body Circumferential direction O1: center axis T1, T2 of inner peripheral surface: height of convex portion S: inner space W1, W2 of outer mold: pitch between convex portions X: foreign matter

Claims (9)

A method for producing a medical tube having a fine relief structure on the inner surface,
An installation step of installing the inner tube and the outer tube in a mold in a state where the outer tube is positioned via an annular space on the inner surface of the inner tube having the fine uneven structure on the inner surface;
And a filling step of filling the annular space with a molding material. In the installation step, a thin tube having an outer diameter smaller than the outer diameter of the inner tube is installed by extending in the axial direction of the inner tube in the annular space,
The method for manufacturing a medical tube according to claim 1, wherein in the filling step, the molding material is filled around the small-diameter tube in the annular space.   The method for manufacturing a medical tube according to claim 2, wherein a plurality of the small-diameter tubes are installed in a circumferential direction of the inner tube.   The method for manufacturing a medical tube according to any one of claims 1 to 3, wherein a convex portion or a concave portion is formed on at least one of an outer surface of the inner tube and an inner surface of the outer tube. The mold includes an internal mold, and an external mold installed on the radially outer side of the internal mold,
5. The installation step according to claim 1, wherein in the installation step, the inner tube is fitted on the outer surface of the inner mold, and the outer tube is fitted on the inner surface of the outer mold. 6. A method of manufacturing a medical tube. The method further includes a removal step of removing the mold after the filling step,
The medical device according to claim 5, wherein the internal mold is an expandable body that is expandable and contractable in a radial direction, and the expandable body is expanded in the filling process and contracted in the removing process. Tube manufacturing method. The method further includes a removal step of removing the mold after the filling step,
The internal mold includes a sheet-shaped mold and a rod-shaped core mold in which the sheet-shaped mold is wound on an outer surface,
The method for producing a medical tube according to claim 5, wherein, in the removing step, the sheet mold is removed from the inner tube after the core mold is removed from the sheet mold.   The method for manufacturing a medical tube according to any one of claims 1 to 7, further comprising a coating step of applying a fluorine coating to a surface of the fine concavo-convex structure. A method for producing a medical tube having a fine relief structure on the inner surface,
An inner tube is installed on the outer surface of the inner mold having a fine uneven pattern, and an annular space is sandwiched between the inner tube and the inner surface of the outer mold located on the radially outer side of the inner tube. The installation process of installing the outer tube at
A filling transfer step of filling the annular space with a molding material and transferring the fine uneven pattern onto the inner surface of the inner tube by the pressure of the molding material.

Images