JP2017169661A - 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 a lamination process for laminating a plurality of sheet members from an outer surface of a base tube having the micro concavo-convex structure on the inner surface toward the outside in a radial direction of the base tube.SELECTED DRAWING: Figure 5

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.

  A method for manufacturing a medical tube as a first aspect of the present invention is a method for manufacturing a medical tube having a fine concavo-convex structure on an inner surface, from the outer surface of the base tube having the fine concavo-convex structure on the inner surface. A laminating step of laminating a plurality of sheet members toward the outside in the radial direction.

  As one embodiment of the present invention, the basic tube is formed by bending a sheet-like base material having the fine concavo-convex structure formed on a surface thereof into a cylindrical shape and joining both end portions of the base material. Is preferred.

  As one embodiment of the present invention, the stacking step includes a winding step of winding a plurality of sheet members around the foundation tube, and an integration step of integrating the wound plurality of sheet members with the foundation tube. It is preferable to contain.

  As one embodiment of the present invention, in the laminating step, the winding integration step of integrating each sheet member with the basic tube is repeated in a state where each sheet member is wound around the basic tube. preferable.

  As one embodiment of the present invention, the plurality of sheet members include an outer layer sheet member forming an outer layer constituting an outer surface of the medical tube, and in the stacking step, the outer layer wound around the base tube It is preferable to join the end portions of the sheet member.

  As one embodiment of the present invention, the plurality of sheet members include an intermediate sheet member sandwiched between the base tube and the outer layer sheet member, and the intermediate sheet members are opposed to each other with a gap between end surfaces. It is preferable to wrap around the base tube.

  As one embodiment of the present invention, when the intermediate sheet member is an inner intermediate sheet member, the plurality of sheet members include an outer intermediate sheet member positioned on a radially outer side of the inner intermediate sheet member, The outer intermediate sheet member is wound around the foundation tube so that the end faces face each other with a gap therebetween, and the position of the gap formed between the end faces of the outer intermediate sheet member in the circumferential direction of the foundation tube is determined. It is preferable to arrange the gaps so as to be different from the positions of the gaps formed between the end surfaces of the inner intermediate sheet member.

  As one embodiment of the present invention, the plurality of sheet members include an intermediate sheet member sandwiched between the base tube and the outer layer sheet member, and the intermediate sheet member is predetermined in a circumferential direction of the base tube. It is preferable to arrange a plurality of them at intervals.

  As one embodiment of the present invention, in the laminating step, a tube may be disposed between the plurality of sheet members laminated with the basic tube or between the plurality of sheet members laminated. preferable.

  As one embodiment of the present invention, it is preferable that the stacking step is performed in a state where a core bar member is present in the basic tube.

  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 to the said fine concavo-convex structure.

  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 figure which shows an example of the manufacturing method of a basic tube. It is a flowchart which shows an example of a lamination process. It is a figure which shows an example of the tube main body which can be manufactured with the manufacturing method of the medical tube which concerns on this invention. It is a figure which shows an example of the tube main body which can be manufactured with the manufacturing method of the medical tube which concerns on this invention. It is a figure which shows an example of the tube main body which can be manufactured with the manufacturing method of the medical tube which concerns on this invention. It is a flowchart which shows an example of a lamination process. It is a figure which shows the example of a core bar member. It is a flowchart which shows an example of the manufacturing method of the tube main body shown in FIG. It is a figure which shows the outline | summary of the winding process of FIG. 7 performed using a core bar member.

  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 body 2 includes a distal end portion 8 including a distal end 5 and an extending direction of the central axis O1 of the inner surface of the tube main body 2 (hereinafter simply referred to as “central axial direction A”). A cuff mounting portion 9 that is continuous on the base end 6 side of the distal end portion 8 and to which the cuff 3 is attached on the outer peripheral surface, a bending portion 10 that is continuous on the base end 6 side of the cuff mounting portion 9, and the bending portion 10 A base end portion 11 that is continuous on the base end 6 side and includes 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 uneven structure 100 (see FIG. 3) is formed, a plurality of intermediate layers, and the tube main body 2. The outer layer 23 which comprises the outer surface of this is provided. In the present embodiment, five intermediate layers 22a, 22b, 22c, 22d, and 22e are provided as the plurality of intermediate layers. Hereinafter, for convenience of explanation, the intermediate layer 22a laminated on the outer surface of the inner layer 21 is referred to as “first intermediate layer 22a”, and the intermediate layer 22b laminated on the outer surface of the first intermediate layer 22a is referred to as “second intermediate layer”. Layer 22b ", the intermediate layer 22c laminated on the outer surface of the second intermediate layer 22b is called" third intermediate layer 22c ", and the intermediate layer 22d laminated on the outer surface of the third intermediate layer 22c is made" 4 intermediate layer 22d ", and the intermediate layer 22e laminated on the outer surface of the fourth intermediate layer 22d is referred to as" fifth intermediate layer 22e ".

  As described above, the tube body 2 of the present embodiment has the inner layer 21, the first intermediate layer 22a, the second intermediate layer 22b, the third intermediate layer 22c, the fourth intermediate layer 22d, and the fifth intermediate layer 22e from the radially inner side. The outer layer 23 is laminated in the order of seven layers.

  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, in other words, 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 surface of the tube main body 2, where 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. . 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, the size of the fine concavo-convex structure 100 is under the above conditions, and the maximum height of the convex portion of the fine concavo-convex structure 100 is several μm to several hundred μm, preferably several μm to several tens μm.

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

  The tube main body 2 shown in FIGS. 1 to 6 includes a laminating process in which a plurality of sheet members are laminated from the outer surface of the basic tube 31 having the fine uneven structure 100 on the inner surface 33 toward the radially outer side of the basic tube 31. Manufactured by.

  The basic tube 31 forms the inner layer 21 of the tube body 2 described above. First, an example of the manufacturing method of the basic tube 31 is demonstrated with reference to FIG. As shown in FIG. 7, the basic tube 31 is formed by bending a sheet-like base material 32 having a fine uneven structure 100 (see FIG. 6) on the surface thereof into a cylindrical shape and joining both ends of the base material 32. It is formed by.

  The sheet-like base material 32 is flexible, is a substantially rectangular sheet material in plan view, and has a thickness of 0.1 mm to 1.0 mm. Moreover, the sheet-like base material 32 can be formed from what was enumerated as a constituent material of the tube main body 2 mentioned above, such as soft polyvinyl chloride, for example.

  On one surface of the sheet-like base material 32, for example, a fine concavo-convex structure 100 (see FIG. 6) transferred by pressing a mold in which a fine concavo-convex pattern obtained by inverting the fine concavo-convex structure 100 is pressed. Is formed.

  The sheet-like base material 32 is bent into a cylindrical shape so that the surface on which the fine concavo-convex structure 100 is formed becomes the inner surface. Specifically, the sheet-like base material 32 is formed by deforming a pair of opposite end portions 34c and 34d into an annular shape so that the surface on which the fine concavo-convex structure 100 is formed becomes an inner surface, and another pair of opposite end portions. A cylindrical shape is formed by abutting the end faces of 34a and 34b. And the base tube 31 which has the fine concavo-convex structure 100 in the inner surface 33 shown in FIG. 7 can be formed by joining the end surfaces of the both ends 34a and 34b which were put together by welding, adhesion | attachment, etc., for example. . In addition, the inner surface 33 of the basic tube 31 becomes the inner surface 60 (refer FIG. 5) of the tube main body 2 mentioned above.

  Here, in the example shown in FIG. 7, the end faces of both end portions 34 a and 34 b are joined in a state of abutting each other. However, the joining method is not limited to this. For example, both end portions 34 a and 34 b are overlapped. You may make it join together. Moreover, you may make it cylindrical by winding the sheet-like base material 32 around core rod jigs, such as metal and resin.

  Further, in the example shown in FIG. 7, the basic tube 31 is formed by bending a sheet-like base material 32 into a cylindrical shape, but a flexible thin wall having a fine concavo-convex structure 100 formed on the outer surface. The above-described basic tube 31 may be created by molding a cylindrical member (for example, 0.1 mm to 1.0 mm) by injection molding or the like and turning the outer surface and the inner surface upside down.

  The tube body 2 is formed by executing a laminating step of laminating a plurality of sheet members on the outer surface of the basic tube 31 formed in this way. Hereinafter, the detail of this lamination process is demonstrated.

  FIG. 8 is a flowchart showing details of the stacking process of the present embodiment. As shown in FIG. 8, the stacking process of the present embodiment includes a winding process S <b> 1 for winding a plurality of sheet members around the foundation tube 31, and an integration process for integrating the wound plurality of sheet members with the foundation tube 31. S2 is included.

  Specifically, the winding step S <b> 1 of the lamination step of the present embodiment is a first step of winding the first intermediate sheet member 35 a (see FIG. 5) serving as the first intermediate layer 22 a of the tube body 2 on the outer surface of the basic tube 31. Winding step S1-1, second winding step S1-2 for winding the second intermediate sheet member 35b (see FIG. 5) serving as the second intermediate layer 22b on the outer surface of the first intermediate sheet member 35a, and the third intermediate layer The third intermediate sheet member 35c (see FIG. 5) to be 22c is wound around the outer surface of the second intermediate sheet member 35b, and the fourth intermediate sheet member 35d (see FIG. 5) is to be the fourth intermediate layer 22d. 5) is wound around the outer surface of the third intermediate sheet member 35c, and the fourth intermediate sheet portion is replaced with the fifth intermediate sheet member 35e (see FIG. 5) serving as the fifth intermediate layer 22e. A fifth winding step S1-5 wound on the outer surface of the 35d, is intended to include an outer layer winding step S1-6 winding an outer layer sheet member 36 as the outer layer 23 on the outer surface of the fifth intermediate sheet member 35e, a.

  The first intermediate sheet member 35a to the fifth intermediate sheet member 35e and the outer layer sheet member 36 that are wound around the basic tube 31 in the winding step S1 are respectively a sheet-like base material 32 that is the original shape of the basic tube 31 described above. Similarly, it is a flexible and substantially rectangular sheet material in plan view, and has a thickness of 0.1 mm to 1.0 mm. Moreover, the sheet-like base material 32 can be formed from what was enumerated as a constituent material of the tube main body 2 mentioned above, such as soft polyvinyl chloride, for example.

  Furthermore, a plurality of sheet members wound in the winding step S1 in the integration step S2 of the lamination step of the present embodiment (in the present embodiment, the first intermediate sheet member 35a to the fifth intermediate sheet member 35e and the outer layer sheet member 36). Is integrated with the basic tube 31. For example, the plurality of sheet members are integrated with the base tube 31 by welding the members adjacent in the radial direction by heating from the outside while the plurality of sheet members are wound on the outer surface of the base tube 31. can do. Specifically, for example, in a state where a plurality of sheet members are wound around the outer surface of the basic tube 31, the sheet is put into an oven (not shown) and heated in the oven. The set temperature is preferably 100 to 180 degrees, more preferably 150 degrees.

  In the above-described winding step S1, the first intermediate sheet member 35a to the fifth intermediate sheet member 35e and the outer layer sheet member 36 are wound separately and sequentially around the basic tube 31, but this method is limited. Instead, for example, two or more sheet members of the first intermediate sheet member 35a to the fifth intermediate sheet member 35e and the outer layer sheet member 36 are integrated in advance by welding, adhesion, or the like, and a plurality of integrated plurality The sheet member may be wound around the basic tube 31. Therefore, all of the first intermediate sheet member 35a to the fifth intermediate sheet member 35e and the outer layer sheet member 36 are integrated in advance by welding, adhesion, or the like, wound around the base tube 31, and then the above-described integration step. S3 may be executed.

  In the above-described laminating step, in the winding step S1, the first intermediate sheet member 35a to the fifth intermediate sheet member 35e and the outer layer sheet member 36 are separately and sequentially wound around the base tube 31, and all the sheet members are wound. The integration step S <b> 2 is performed after the winding, but is not limited to this method. For example, each time the sheet member is wound around the base tube 31, the sheet member is foundationed by welding or adhesion. It may be integrated with the tube 31. Details of the manufacturing method of such a tube body will be described later (see FIG. 12).

  Furthermore, it is preferable that the above-mentioned lamination process includes the process of joining the edge parts of the outer-layer sheet member 36 which forms the outer layer 23 (refer FIG. 5) wound around the base tube 31. FIG. If it does in this way, the outer layer 23 of the tube main body 2 can be made into the continuous cylindrical shape without the clearance gap in the circumferential direction B, and it can suppress that a groove | channel is formed in the outer surface of the tube main body 2. FIG. Thereby, when inserting the tube main body 2 of the tracheal tube 1 from the outside of the body into the trachea and when removing the tube main body 2 from the inside of the trachea to the outside of the body, it is possible to prevent the outer surface of the tube main body 2 from being caught on the skin or the inner wall of the trachea.

  Note that the end portions of the outer layer sheet member 36 wound around the basic tube 31 can be joined by various joining methods such as welding by heating and adhesion by an adhesive. In addition, as shown in FIG. 5, the end portions of the outer layer sheet member 36 may be joined by abutting the end surfaces of both end portions, or may be joined by overlapping the end portions. However, it is preferable that end surfaces of both end portions of the outer layer sheet member 36 wound around the basic tube 31 are butted together and joined. In this way, it is possible to further suppress the formation of a step on the outer surface of the tube body 2.

  Moreover, it is preferable that the above-mentioned lamination process is performed in a state where the core bar member is in the basic tube 31. Specifically, in the above-described laminating step, the core rod member is inserted into the basic tube 31, and the winding step S1 and the integration step S2 are performed in this state. If it does in this way, since winding process S1 and integration process S2 can be performed in the state where the cross-sectional shape of basic tube 31 is maintained, a lamination process can be made easy. As the core rod member referred to here, the core rod jig used when the above-described sheet-like base material 32 is formed into a cylindrical shape may be used as it is. You may make it insert in. Further, in the integration step S2, when the basic tube 31 and the plurality of sheet members are integrated by heating and melting, it is preferable to form the core bar member with a resin material having low thermal conductivity and high heat insulation. If it does in this way, it can control that fine concavo-convex structure 100 of inner surface 33 of basic tube 31 melts by the heated core stick member.

  Further, when the above-described integration step S2 is performed with the core rod member inserted, the core rod member 40 is made up of a rod-shaped core portion 41 and the core portion 41 as shown in FIG. And an annular portion 42 disposed on the outer surface. The annular portion 42 is formed of a thin member having flexibility. For example, the annular portion 42 can be formed by winding a flexible sheet-like member around the core portion 41 and joining the end portions together. In the integration step S2, when the basic tube 31 and the plurality of sheet members are integrated by heating and melting, the core portion 41 and the annular portion 42 are formed of a resin material having low thermal conductivity and high heat insulation. It is preferable. As such a resin material, a resin called a super engineering plastic can be used. For example, polyarylate (PAR), polysulfone (PSU), polyethersulfone (PES), polyamideimide (PAI), polyether Imide (PEI), polyphenylene sulfide (PPS), polyether ether ketone (PEEK), liquid crystal polymer (PCP), polyimide (PI), fluororesin (PFA, EPA), or the like can be used.

  If the core rod member 40 has the above-described configuration, the inner surface 33 (see FIG. 7) in which the basic tube 31 is reduced in diameter in the integration step S2 and the fine uneven structure 100 (see FIG. 6 and the like) of the basic tube 31 is formed. Even if it adheres to the outer surface of the core rod member 40, the core portion 41 is removed from the annular portion 42, and then the annular portion 42 is easily peeled off from the inner surface 33 of the basic tube 31 by, for example, folding or deforming. be able to. Therefore, it is not necessary to force the core bar member 40 to slide with the fine concavo-convex structure 100, and the fine concavo-convex structure 100 can be made difficult to break.

  Moreover, it is good also as a core rod member 43 as shown in FIG.13 (b) other than the core rod member 40 shown to Fig.13 (a). The core rod member 43 shown in FIG. 13B is a balloon as an expansion body that can expand and contract in the radial direction. The balloon shown in FIG. 13 (b) expands in the radial direction by supplying gas or liquid to the internal space 44 (see the bold arrow in FIG. 13 (b)), and allows the gas or liquid to be discharged from the internal space 44. (See the white arrow in FIG. 13B). In this way, the diameter of the basic tube 31 is reduced in the integration step S <b> 2, and the inner surface 33 (see FIG. 7) on which the fine uneven structure 100 (see FIG. 6, etc.) of the basic tube 31 is formed. Even if it adheres to the outer surface, the expansion body as the core rod member 43 can be contracted and easily removed from the basic tube 31. Specific examples of such an expanded body include elastic members such as a self-expanding net-like cylindrical member and a spiral or spiral spring member in addition to the balloon shown in FIG.

  Further, the core rod member 40 shown in FIG. 13A and the core rod member 43 shown in FIG. 13B can be used not only in the integration step S2 but also in the winding step S1 as described above. FIG. 15 is a diagram showing an outline when the core rod member 40 shown in FIG. 13A is used in the winding step S1. As shown in FIG. 15, when the core rod member 40 is used as a winding core and the first intermediate sheet member 35a to the fifth intermediate sheet member 35e and the outer layer sheet member 36 are wound around the core rod member 40, there is no core rod member. Compared with, the work of the winding step S1 becomes easier.

  Here, the first intermediate sheet member sandwiched between the cylindrical base tube 31 and the outer layer sheet member 36 joined in a cylindrical shape to form the first intermediate layer 22a to the fifth intermediate layer 22e of the tube body 2. Details of the 35a to the fifth intermediate sheet member 35e will be described.

  As shown in FIG. 5, a first lumen 12, a second lumen 13, and a third lumen 14 are provided in the wall of the tube body 2. In the present embodiment, the first lumen 12, the second lumen 13, and the third lumen 14 described above are adjusted by adjusting how the first intermediate sheet member 35a to the fifth intermediate sheet member 35e are wound around the base tube 31. Is forming.

  Specifically, each of the first intermediate sheet member 35a and the second intermediate sheet member 35b of the present embodiment is arranged at the same position in the circumferential direction of the basic tube 31 so that the end surfaces face each other with a gap therebetween. It is wrapped around.

  Thus, the intermediate sheet member positioned between the cylindrical base tube 31 and the outer layer sheet member 36 joined in a cylindrical shape is wound around the base tube 31 so that the end faces face each other with a gap therebetween. If so, the lumen in the wall of the tube body 2 can be formed by this gap. Specifically, the first intermediate sheet member 35a and the second intermediate sheet member 35b of the present embodiment form a gap that becomes the second lumen 13 of the tube body 2 (see FIG. 5).

  Similarly, the third intermediate sheet member 35c of the present embodiment is also wound around the basic tube 31 so that the end faces face each other with a gap therebetween. However, in the circumferential direction of the basic tube 31, the position of the gap between the end faces of the third intermediate sheet member 35c is different from the position of the gap between the end faces of the first intermediate sheet member 35a and the second intermediate sheet member 35b. Yes. And the 3rd intermediate sheet member 35c forms the gap used as the 1st lumen 12 of tube body 2 (refer to Drawing 5).

  Further, the fifth intermediate sheet member 35e of the present embodiment is also wound around the basic tube 31 so that the end faces face each other with a gap therebetween. However, in the circumferential direction of the basic tube 31, the position of the gap between the end faces of the fifth intermediate sheet member 35e is the position of the gap between the end faces of the first intermediate sheet member 35a and the second intermediate sheet member 35b, and 3 is different from the position of the gap between the end faces of the intermediate sheet member 35c. And the 5th intermediate sheet member 35e forms the gap used as the 3rd lumen 14 of tube body 2 (refer to Drawing 5).

  As described above, in the circumferential direction of the basic tube 31, the position of the gap formed by the radially outer intermediate sheet member (outer intermediate sheet member) is set as the gap formed by the radially inner intermediate sheet member (inner intermediate sheet member). A plurality of lumens can be formed at different positions in the circumferential direction of the basic tube 31 by disposing them differently. The relationship between the outer intermediate sheet member and the inner intermediate sheet member here is satisfied by a combination of two of the first intermediate sheet member 35a to the fifth intermediate sheet member 35e of the present embodiment. As an example, a combination of the third intermediate sheet member 35c and the second intermediate sheet member 35b may be used.

  Note that a plurality of the fourth intermediate sheet members 35d of the present embodiment are arranged at predetermined intervals in the circumferential direction of the basic tube 31. Specifically, in the present embodiment, two fourth intermediate sheet members 35d1 and 35d2 are stacked on the outer surface of the third intermediate sheet member 35c. A first lumen between one end portion in the circumferential direction of the foundation tube 31 of one fourth intermediate sheet member 35d1 and one end portion in the circumferential direction of the foundation tube 31 of another fourth intermediate sheet member 35d2. A gap of 12 is formed. In addition, between the other end portion in the circumferential direction of the foundation tube 31 of one fourth intermediate sheet member 35d1 and the other end portion in the circumferential direction of the foundation tube 31 of another fourth intermediate sheet member 35d2, A gap to be a three lumen 14 is formed.

  In this way, by disposing a plurality of intermediate sheet members at a predetermined interval in the circumferential direction of the basic tube 31, different positions in the circumferential direction B of the tube body 2 in a cross-sectional view of the tube body 2 (see FIG. 5). In addition, another lumen can be formed at a position where the radial distance from the central axis O1 is equal.

  In the present embodiment, the fourth intermediate layer 22d is formed by the two fourth intermediate sheet members 35d1 and 35d2. However, the present invention is not limited to this configuration, and the number of lumens in the wall of the tube body 2 is not limited. Depending on the position in the radial direction, a plurality of other intermediate sheet members may be arranged at predetermined intervals in the circumferential direction of the basic tube 31. For example, as in a tube body 202 as a medical tube shown in FIG. 9, a plurality of first intermediate sheet members 35a to 35e may be arranged at predetermined intervals in the circumferential direction. .

  In the tube main body 202 shown in FIG. 9, the first intermediate sheet member 35 a to the fifth intermediate sheet member 35 e are arranged in the circumferential direction of the basic tube 31 with a predetermined interval therebetween. Each of the first intermediate sheet member 35 a to the fifth intermediate sheet member 35 e forms a gap that becomes the first lumen 12, the second lumen 13, and the third lumen 14 at the same position in the circumferential direction B of the basic tube 31. ing.

  Here, in the manufacturing method of the tube main body 2 shown in FIG. 5 and the manufacturing method of the tube main body 202 shown in FIG. 9, the ends of the first intermediate sheet member 35a to the fifth intermediate sheet member 35e face each other with a gap therebetween. Thus, by winding around the base tube 31 or by arranging a plurality of intermediate sheet members at predetermined intervals in the circumferential direction (for example, two fourth intermediate sheet members 35d1 and 35d2 shown in FIG. 5) Although the first lumen 12, the second lumen 13, and the third lumen 14 are formed, the method for forming the lumen in the wall of the tube body is not limited to this method.

  For example, a plurality of sheet members (the first intermediate sheet member 35a to the fifth intermediate sheet member 35e and the outer layer sheet member in FIG. 10) laminated with the basic tube 31 like a tube main body 302 as a medical tube shown in FIG. 36), or between the plurality of laminated sheet members, the thin tubes 50a, 50b and 50c may be arranged. The tubes 50a, 50b, and 50c constitute the first lumen 12, the second lumen 13, and the third lumen 14 of the tube main body 302, respectively. In addition, in the cross section orthogonal to the central axis direction of the tube main body 302 (see FIG. 10), the outer shape of the tubes 50a, 50b, and 50c is not limited to the circular shape or the curved elliptical shape shown in FIG. It is good. Further, the maximum outer diameter of the tubes 50 a, 50 b, 50 c is smaller than the outer diameter of the basic tube 31. Here, “the maximum outer diameter of the tube” in the case where the cross-sectional outer shape of the tube is other than a circular shape means a length in which the linear distance between two points on the outer edge is maximum in the cross-section of the tube. .

  Thus, by forming the lumen in the wall of the tube main body 302 with the small diameter tubes 50a, 50b, 50c, the cross-sectional shape of the lumen can be stabilized as compared with the case where the small diameter tube is not used. Can do.

  Further, in the present embodiment, the thickness of the tube main body 2 is made substantially equal regardless of the position in the circumferential direction B in the cross-sectional view of the tube main body 2, but is not limited to this configuration. Depending on the circumferential direction B, the thickness of the tube body may be different. FIG. 11 is a cross-sectional view illustrating an example of a tube main body having a thickness different depending on the circumferential direction B.

  As shown in FIG. 11, in the tube main body 402 as a medical tube, the first intermediate layer 22a is formed on the radially outer side from the basic tube 31 forming the inner layer 21 as in the case of the tube main body 2 described above. The sheet member 35a, the second intermediate sheet member 35b that forms the second intermediate layer 22b, the third intermediate sheet member 35c that forms the third intermediate layer 22c, the fourth intermediate sheet member 35d that forms the fourth intermediate layer 22d, The fifth intermediate sheet member 35e forming the fifth intermediate layer 22e and the outer layer sheet member 36 forming the outer layer 23 are laminated in this order. However, in the tube main body 402 shown in FIG. 11, the sixth intermediate layer 22 f is formed only in a portion where the first lumen 12 and the second lumen 13 are formed in the circumferential direction B of the tube main body 402 in the cross-sectional view of the tube main body 402. A sixth intermediate sheet member 35f is provided. That is, in the cross-sectional view of the tube main body 402, the portion where the first lumen 12 and the second lumen 13 are formed is formed thicker than the other portions.

  As described above, the thickness of the tube main body 402 may be varied depending on the position in the circumferential direction B. For example, when it is desired to increase the inner diameter of some of the plurality of lumens, the position of the lumen may be increased. In addition, for example, when a linear tube material is formed by the above-described lamination process, the tube material is bent to form a bending portion (see the bending portion 10 in the tube main body 2 in FIG. 2). In other words, the portion on which the second lumen 13 is formed in the circumferential direction B in the example shown in FIG. In this way, the thickened portion is stretched and deformed slightly when the curved portion is formed, and is substantially uniform regardless of the position in the circumferential direction B when the tube body 402 having the curved portion is formed. A tube body 402 having a sufficient thickness can be realized. Thus, the thickness of the tube body can be adjusted according to various purposes.

  Next, another example of the lamination process in the manufacturing method of the tube body 2 will be described. The above-described laminating step includes a winding step S1 in which a plurality of sheet members are wound around the base tube 31 and an integration step S2 in which the plurality of wound sheet members are integrated with the base tube 31. However, the lamination process demonstrated here repeats the process which integrates each sheet | seat member with the foundation tube 31 in the state which wound each sheet | seat member around the foundation tube 31. FIG. FIG. 12 is a flowchart when this lamination process is applied to the method of manufacturing the tube body 2. In addition, since the manufacturing method of the basic tube 31 is the same as that of what was mentioned above, description is abbreviate | omitted here.

  As shown in FIG. 12, in the above-described laminating step, the first intermediate sheet member 35a to be the first intermediate layer 22a is wound around the outer surface of the basic tube 31, and the basic tube 31 and the first intermediate sheet member 35a are integrated. The first winding integration step T1 and the second intermediate sheet member 35b to be the second intermediate layer 22b is wound on the outer surface of the first intermediate sheet member 35a, and the first intermediate sheet member 35a and the second intermediate sheet member 35b are wound. And the second intermediate sheet member 35c, which is the third intermediate layer 22c, is wound on the outer surface of the second intermediate sheet member 35b. A third winding integration step T3 for integrating the intermediate sheet member 35c, a fourth intermediate sheet member 35d to be the fourth intermediate layer 22d is wound on the outer surface of the third intermediate sheet member 35c, and the third middle A fourth winding integration step T4 for integrating the sheet member 35c and the fourth intermediate sheet member 35d, and winding the fifth intermediate sheet member 35e to be the fifth intermediate layer 22e on the outer surface of the fourth intermediate sheet member 35d , A fifth winding integration step T5 for integrating the fourth intermediate sheet member 35d and the fifth intermediate sheet member 35e, and winding the outer layer sheet member 36 to be the outer layer 23 on the outer surface of the fifth intermediate sheet member 35e, A sixth winding integration step T6 for integrating the fifth intermediate sheet member 35e and the outer layer sheet member 36, and the first step T1 to the sixth step T6 are all wound and integrated. The same process is repeated. In addition, the method of integrating the layers adjacent to each other in the radial direction of the basic tube 31 is not particularly limited, and for example, welding by heating or adhesion by an adhesive can be used.

  As described above, the tube body 2 as a medical tube can be manufactured through the above-described lamination process (see FIGS. 8 and 12). Here, before or after the above-described laminating step (see FIGS. 8 and 12), the fluorine coat layer 200 (see FIG. 3) is formed on the surface of the fine concavo-convex structure 100 formed on the inner surface 33 of the basic tube 31. A coating process may be performed. FIG. 14 is a flowchart showing a method for manufacturing the tube body 2 when the coating step S0 is performed before the lamination step shown in FIG. Since the winding step S1 and the integration step S2 shown in FIG. 14 are the same as those described above, the description thereof is omitted here, and the coating step S0 will be described.

  In the coating step S0, the surface of the fine concavo-convex structure 100 formed on the inner surface 33 of the basic 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 of applying the fluorine coating agent, a dip coating method in which the basic tube 31 is immersed in a solvent containing the fluorine coating agent, or a solvent containing the fluorine coating agent is poured into the basic 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 basic tube 31 is dried in a state where the solvent containing the fluorine coating agent is applied. The solvent is removed and a film of the fluorine coating agent is formed. Next, the fluorine coating agent is cured to form a bond with the fine concavo-convex structure 100. As an example of an aspect of curing the fluorine coating agent, for example, the basic 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 coating layer 200, the water repellency, oil repellency and friction resistance of the inner surface 33 of the basic tube 31 can be improved and formed on the inner surface 33. The strength of the fine concavo-convex structure 100 can be improved. Therefore, the fine concavo-convex structure 100 can be made difficult to be damaged during the winding step S2 and the integration step S3.

  The coating process S0 may be performed after the integration process S2. Moreover, you may perform the same coating process before the lamination process shown in FIG. That is, you may make it manufacture the tube main body 2 by performing the integration process T1 with a 1st volume to the integration process T6 with a 6th volume after a coating process. Further, as shown in FIG. 7, when the basic tube 31 is formed from the sheet-like base material 32, the fine unevenness is formed before the sheet-like base material 32 on which the fine unevenness structure 100 is formed is bent into a cylindrical shape. It is preferred to apply a fluorine coating to the surface of structure 100. 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 step of bending the sheet-like base material 32 into a cylindrical shape.

  The method for manufacturing a medical tube according to the present invention can be realized by various specific methods without departing from the scope of the claims, and is limited to the method shown in the above-described embodiment. is not. Therefore, as long as it does not deviate from the description of the scope of claims, it is also within the technical scope to combine the steps in the above-described method for manufacturing a tube body as a medical tube and to make another manufacturing method. . For example, in the manufacturing method of the tube body 2 described above, a gap is formed between the ends of the wound intermediate sheet member, and the first lumen 12 and the second lumen in the wall of the tube body 2 are utilized using the gap. The lumen 13 and the third lumen 14 are formed. After the gap is created, the small-diameter tubes 50a, 50b, and 50c shown in FIG. 12, the second lumen 13 and the third lumen 14 may be formed.

  Moreover, although the tube main bodies 2, 202, 302, and 402 as the medical tubes described above are configured to include a plurality of intermediate layers, it is sufficient that at least one intermediate layer is present, and the structure is limited to the above-described layer configuration. It is not a thing. Therefore, FIG. 8 shows the first winding step S1-1 to the fifth winding step S1-5 for winding the first intermediate sheet member 35a to the fifth intermediate sheet member 35e, respectively. It is changed according to the number of layers. Similarly, FIG. 12 shows the first winding integration step T1 to the fifth winding integration step T5 in which the first intermediate sheet member 35a to the fifth intermediate sheet member 35e are wound and integrated, respectively. The number of man-hours in the attaching step is also changed according to the number of intermediate layers.

  In the present application, the “inner layer of the tube main body” means a layer formed by the basic tube, and when the basic tube 31 is a single layer (single layer) as in the above-described embodiment, the tube main body. The two inner layers 21 are also one layer. However, when the basic tube is formed of a plurality of layers, the inner layer of the tube main body is also a plurality of layers.

  Furthermore, in the above-described embodiment, the method for manufacturing a tube body 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. It can also be applied 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, 202, 302, 402: 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: Tube body inner layer 22: Tube body intermediate layer 22a: First intermediate layer 22b: Second intermediate layer 22c: 3rd intermediate | middle layer 22d: 4th intermediate | middle layer 22e: 5th intermediate | middle layer 22f: 6th intermediate | middle layer 23: Outer layer 31 of a tube main body: Foundation tube 32: Base material 33: Inner surface of a foundation tube 4a, 34b, 34c, 34d: end 35a of the substrate: a first intermediate sheet member 35b: second intermediate sheet member (inner intermediate sheet member)
35c: Third intermediate sheet member (outer intermediate sheet member)
35d, 35d1, 35d2: fourth intermediate sheet member 35e: fifth intermediate sheet member 35f: sixth intermediate sheet member 36: outer layer sheet member 40: core rod member 41: core portion 42: annular portion 43: core rod member 44: Internal space 50a, 50b, 50c: Tube 60: Inner surface of tube body 100: Fine uneven structure 101: Convex rib (convex part)
102: Groove 103: Projection (convex part)
105: Top surface 200: Fluorine coating layer A: Central axis direction of tube body B: Circumferential direction of tube body O1: Center axis line of inner surface of tube body X: Foreign matter

Claims (11)

A method for producing a medical tube having a fine relief structure on the inner surface,
A method for manufacturing a medical tube, comprising a laminating step of laminating a plurality of sheet members from an outer surface of a basic tube having the fine concavo-convex structure on an inner surface toward a radially outer side of the basic tube.   The medical tube according to claim 1, wherein the basic tube is formed by bending a sheet-like base material having the fine uneven structure formed on a surface thereof into a cylindrical shape and joining both end portions of the base material. Manufacturing method. The laminating step is a winding step of winding a plurality of sheet members around the basic tube;
The manufacturing method of the medical tube of Claim 1 or 2 including the integration process of integrating the said some sheet | seat member wound with the said basic | foundation tube.   The medical use according to claim 1 or 2, wherein, in the laminating step, a winding integration step of integrating the sheet members with the basic tube is repeated in a state where the sheet members are wound around the basic tube. Tube manufacturing method. The plurality of sheet members include an outer layer sheet member forming an outer layer constituting an outer surface of the medical tube,
5. The method of manufacturing a medical tube according to claim 1, wherein in the laminating step, ends of the outer layer sheet member wound around the basic tube are joined to each other. The plurality of sheet members include an intermediate sheet member sandwiched between the basic tube and the outer layer sheet member,
The method for manufacturing a medical tube according to claim 5, wherein the intermediate sheet member is wound around the base tube so that end faces thereof face each other with a gap therebetween. When the intermediate sheet member is an inner intermediate sheet member, the plurality of sheet members include an outer intermediate sheet member positioned on the radially outer side of the inner intermediate sheet member,
Wrap the outer intermediate sheet member around the foundation tube so that the end faces face each other with a gap between them,
The position of the gap formed between the end surfaces of the outer intermediate sheet member is different from the position of the gap formed between the end surfaces of the inner intermediate sheet member in the circumferential direction of the base tube. The manufacturing method of the medical tube of description. The plurality of sheet members include an intermediate sheet member sandwiched between the basic tube and the outer layer sheet member,
The method of manufacturing a medical tube according to claim 5, wherein a plurality of the intermediate sheet members are arranged at predetermined intervals in the circumferential direction of the basic tube.   9. The tube according to claim 1, wherein, in the stacking step, a tube is disposed between the base tube and the plurality of sheet members stacked or between the plurality of sheet members stacked. The manufacturing method of the medical tube of description.   The said lamination process is a manufacturing method of the medical tube as described in any one of Claims 1 thru | or 9 performed in the state which has a core bar member in the said basic | foundation tube.   The method for manufacturing a medical tube according to any one of claims 1 to 10, further comprising a coating step of applying a fluorine coating to the fine concavo-convex structure.

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