JP2017169664A - 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 process for inserting a bent sheet member or a thin member which is an inner tube into an outer tube, a process for integrating the thin member into the inner surface of the outer tube, and a process for melting at least part of the inner surface of the thin member and exhibiting the micro concavo-convex structure.SELECTED DRAWING: Figure 8

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.

  Then, this invention aims at providing 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 according to an aspect of the present invention is a method for manufacturing a medical tube having a fine concavo-convex structure on the inner surface, and a bent sheet member or a thin-walled member that is an inner tube is inserted into the outer tube. And a step of integrating the thin member with an inner surface of the outer tube, and a step of melting at least a part of the inner surface of the thin member to develop the fine concavo-convex structure.

  The thin-walled member has the fine concavo-convex structure formed on the inner surface, is provided on the fine concavo-convex structure with a base portion that is insoluble in water or a predetermined solvent that is a predetermined organic solvent, and is soluble in the predetermined solvent. A surface layer portion, and the surface layer portion is melted with the predetermined solvent to develop the fine concavo-convex structure.

  Further, it is preferable that the predetermined solvent is allowed to reach the surface layer portion by flowing from one end opening of the outer tube in which the thin member is integrated.

  The thin-walled member includes a base portion having the fine concavo-convex structure formed on an inner surface thereof, and a surface layer portion provided on the fine concavo-convex structure and having a melting point lower than that of the base portion, and is heated by heating. It is preferable to melt the surface layer portion to express the fine uneven structure.

  Further, by heating from the outside of the outer tube, the outer tube is reduced in diameter, the inner surface of the outer tube is brought into close contact with the outer surface of the thin member, and the thin member and the outer tube are integrated. It is preferable.

  The thin-walled member includes a base portion having the fine concavo-convex structure formed on the inner surface thereof, and a surface layer portion provided on the fine concavo-convex structure and having a melting point lower than that of the base portion. The outer tube is reduced in diameter and the inner surface of the outer tube is brought into close contact with the outer surface of the thin member, so that the thin member and the outer tube are integrated, and the surface layer portion is melted. Thus, it is preferable to develop the fine uneven structure.

  Moreover, it is preferable to further include a step of applying a fluorine coating to the developed fine uneven structure.

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

It is a figure which shows the state which detained the tracheal tube manufactured using the manufacturing method of the medical tube as one Embodiment of this invention in the trachea. It is a perspective view which shows the tube main body in the tracheal tube shown in FIG. It is an expanded sectional view which shows the fine concavo-convex structure formed in the inner surface of the tube main body shown in FIG. It is the figure which looked at the tracheal tube shown in FIG. 1 from the base end side. It is sectional drawing of the direction perpendicular | vertical to the center axis direction of the tube main body shown in FIG. It is an 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 the formation flow of the medical tube as one Embodiment of this invention. It is a figure which shows the outline | summary of each process of the formation flow shown in FIG. It is sectional drawing of a sheet | seat 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.

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

  As shown in FIG. 2, the tube main body 2 is described as a distal end portion 8 including the distal end 5 and an extending direction of the central axis O1 of the inner peripheral surface of the tube main body 2 (hereinafter simply referred to as “central axial direction A”). ) On the proximal end 6 side of the distal end portion 8 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.

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

  The example of the uneven | corrugated pattern of the fine concavo-convex structure 100 formed in the inner surface 31 of the tube main body 2 as a medical tube is shown. FIG. 6 is an enlarged view of a part of the developed view of the inner surface 31 of the tube main body 2 as a medical tube. The horizontal direction in the figure indicates the central axis direction A of the tube main body 2 of the tracheal tube 1 and the vertical direction. Shows the circumferential direction B of the tube body 2 of the tracheal tube 1. 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 still more preferably 1 μm to 30 μm, and particularly preferably 1 μm to 20 μm. When it is larger than 50 μm, the contact area with the heel increases, and the repellency effect decreases. On the other hand, when the thickness is less than 0.01 μm, it is difficult to form the convex portion, and the shape stability may be lowered. When the fine concavo-convex structure 100 is a line and space structure, the maximum width of the top surface 105 (see FIG. 3) of each convex portion is the maximum length of the top surface 105 in the direction orthogonal to the extending direction of the convex rib 101. It becomes.

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

  FIG. 7 shows a flow of forming the tube main body 2 as a medical tube. Moreover, FIG. 8 is a figure which shows the outline | summary of each process of the formation flow shown in FIG.

  This manufacturing method includes a step (P1) of bending the sheet member 32 by winding the sheet member 32 as a thin member around the core rod member 50, and a step (P2) of inserting the bent sheet member 32 into the outer tube 22. The step (P3) of integrating the sheet member 32 with the inner surface of the outer tube 22, the step (P4) of pulling out the core bar member 50 from the integrated outer tube 22 and sheet member 32, and the inner surface of the sheet member 32 It includes a step (P5) of melting at least a part to develop the fine concavo-convex structure 100 and a step (P6) of forming the fluorine coat layer 200 on the surface of the fine concavo-convex structure 100. Here, the diagrams shown in FIGS. 8A to 8E correspond to the steps (P1) to (P5), respectively. Hereinafter, the details of each of the steps will be described.

<Process (P1) of winding sheet member 32 around core rod member 50 and bending sheet member 32>
A process (P1) of winding the sheet member 32 as a thin member around the core rod member 50 and bending the sheet member 32 will be described. First, the sheet member 32 will be described. The sheet member 32 is a sheet-like member having a predetermined thickness. The thickness of the sheet member 32 is preferably 0.1 mm to 1.0 mm, more preferably 0.15 mm to 0.5 mm. Further, when the sheet member 32 has a rectangular shape when viewed from the thickness direction, preferably, the length of one opposing two sides of the sheet member 32 bent into a circular shape is set within the outer tube 22. The length is approximately equal to the circumference, and the length of the other two opposite sides is equal to or longer than the length in the axial direction of the outer tube 22. Thereby, the whole area of the inner surface of the outer tube 22 in the circumferential direction and the axial direction can be covered with the sheet member 32 at the time of insertion in the step (P2) described later.

  As shown in FIG. 8A, a cylindrical core rod member 50 is used, the sheet member 32 is wound around the outer surface of the core rod member 50, and bent into a cylindrical shape along the shape of the outer surface of the core rod member 50. Specific examples of the core rod member 50 include a solid or hollow metal rod and a resin rod. In addition, specific examples of the core rod member 50 include expansion members such as a self-expanding reticulated tube 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. .

<Step of inserting the bent sheet member 32 into the outer tube 22 (P2)>
Next, the process (P2) of inserting the bent sheet member 32 into the outer tube 22 will be described. As shown in FIG. 8B, the cylindrically bent sheet member 32 is inserted into the outer tube 22 from one end to the other end of the outer tube 22 (the arrow in FIG. 8B). 51). Within the outer tube 22, the sheet member 32 is moved relative to the outer tube 22 and moved to a predetermined position in the outer tube 22.

  Preferably, the shape of the sheet member 32 is fixed by fixing one end of the sheet member 32 to a fixing jig, and the sheet member 32 is inserted into the outer tube 22. In FIG. 8B, the above-described core rod member 50 is used as it is as a fixing jig, but another fixing jig may be used instead of the core rod member 50.

<Step of integrating the sheet member 32 on the inner surface of the outer tube 22 (P3)>
Next, the process (P3) of integrating the sheet member 32 with the inner surface of the outer tube 22 will be described. In a state where the sheet member 32 is inserted into the outer tube 22, these are heated from the outside of the outer tube 22. As the heating device, for example, a heater, an ultrasonic generator, or a high frequency generator can be used. As an example of the heating mode, for example, the outer tube 22 in which the sheet member 32 is inserted can be put into an oven (not shown) and heated in the oven. The set temperature is preferably 100 to 180 degrees, more preferably 150 degrees.

  Outer tube 22 of the present embodiment is made of a material that softens when heated from the outside, that is, a material having thermoplasticity, among the constituent materials of tube body 2 described above. Therefore, the outer tube 22 contracts due to heating from the outside. Therefore, by heating from the outside, the outer tube 22 is reduced in diameter, and the inner surface of the outer tube 22 faces the inner surface of the outer tube 22 among the surfaces of the sheet member 32 (hereinafter, “the outer surface of the sheet member 32”). ). In this way, the outer tube 22 is stuck and fixed on the outer surface of the sheet member 32, whereby the sheet member 32 and the outer tube 22 are integrated (see FIG. 8C). Furthermore, the outer tube 22 and the sheet member 32 may be integrated more firmly by melting and welding the inner surface of the outer tube 22 and the outer surface of the sheet member 32.

  As shown in FIG. 8 (c), when the outer tube 22 is reduced in diameter by the core rod member 50 being inserted into the sheet member 32 during heating, the sheet member 32 becomes the inner surface of the outer tube 22. It can suppress that it deform | transforms from the state in alignment with radial direction inner side. Therefore, the outer tube 22 and the sheet member 32 can be more firmly integrated, and the cross-sectional shape of the manufactured tube body 2 (see FIG. 2) can be made more uniform. Here, it has been described that the core rod member 50 used when the sheet member 32 is formed into a cylindrical shape is used as it is. However, instead of the core rod member 50, another core rod member is disposed inside the sheet member 32. The sheet member 32 and the outer tube 22 may be heated together.

  In the above-described example, the integration by heating from the outside has been described. However, the present invention is not limited to this, and the outer surface of the sheet member 32 and the inner surface of the outer tube 22 are integrated using a solvent or an adhesive. It may be a method. As the adhesive, an instantaneous adhesive or a UV curable adhesive can be used. It is preferable that the sheet member 32 and the outer tube 22 have the same flexibility.

<Step of Pulling Out Core Rod Member 50 from Integrated Outer Tube 22 and Sheet Member 32 (P4)>
After the sheet member 32 and the outer tube 22 are integrated, the core bar member 50 is pulled out as shown in FIG. 8D (see the arrow 52 in FIG. 8D).

<Step of melting at least a part of the inner surface of the sheet member 32 to develop the fine concavo-convex structure 100 (P5)>
In this step (P5), as shown in FIG. 8E, water or a predetermined solvent 70, which is a predetermined organic solvent, is poured from one end opening of the outer tube 22 in which the sheet member 32 is integrated (FIG. 8). (See arrow 53 in (e)).

  Here, details of the sheet member 32 will be described. FIG. 9 is a cross-sectional view of the sheet member 32. The sheet member 32 includes a base portion 41 and a surface layer portion 42. Of the surface of the base portion 41, the surface that becomes the inner surface in a state in which the sheet member 32 is integrated with the outer tube 22 (hereinafter referred to as “the inner surface of the base portion 41”) is lined as the fine concavo-convex structure 100. An and-space structure (see FIG. 6A) is formed. The base 41 is insoluble in water or a predetermined solvent 70 that is a predetermined organic solvent. The surface layer portion 42 is provided on the fine concavo-convex structure 100. Further, the surface layer portion 42 is soluble in the above-described predetermined solvent 70 in which the base portion 41 does not dissolve.

  Specific examples of the predetermined solvent 70 include water, acetone as an organic solvent, hexane, cyclohexanone, tetrahydrofuran, and the like. Moreover, as a constituent material of the base part 41, a fluororesin (for example, Teflon (registered trademark)) or a phenol resin having a property insoluble in the solvent 70 can be used. When the above-mentioned organic solvent is used as the predetermined solvent 70, as a constituent material of the surface layer portion 42, soft polyvinyl chloride having a property of being soluble in these organic solvents can be used.

  FIG. 9 is a cross-sectional view of the sheet member 32. As described above, the surface layer portion 42 is provided on the fine concavo-convex structure 100. Hereinafter, the line and space structure described above as the fine concavo-convex structure 100 will be described as an example. Specifically, as shown in FIG. 9A, the surface layer portion 42 is accommodated in the concave groove 102 in the fine concavo-convex structure 100. However, the structure is not limited to this, and any structure that can expose the fine concavo-convex structure 100 by melting the surface layer portion 42 may be used. For example, as shown in FIG. 9B, the surface layer portion 42 is accommodated in the concave groove 102 of the line and space structure as the fine concavo-convex structure 100 so as to cover both the convex rib 101 and the concave groove 102. It may be provided. And the surface layer part 42 may be provided so that the surface of the fine concavo-convex structure 100 may be covered over the whole. Alternatively, as shown in FIG. 9C, the surface layer portion 42 is not accommodated in the concave groove 102 of the line and space structure as the fine concavo-convex structure 100 so as to cover both the convex rib 101 and the concave groove 102. May be provided. And the surface layer part 42 may be provided so that the area | region in which the fine concavo-convex structure 100 was formed may be covered over the whole.

  Although the fine concavo-convex structure 100 having a line-and-space structure has been described with reference to FIG. 9, the present invention is not limited to this, and the fine concavo-convex structure 100 having a pillar structure (see FIG. 6B) is also shown in FIG. The relationship between the base part 41 and the surface layer part 42 can be realized.

  The predetermined solvent 70 described above is adhered to the inner surface of the sheet member 32 integrated with the outer tube 22. The surface layer portion 42 is dissolved by the solvent 70. On the other hand, the base portion 41 does not dissolve in the solvent 70. Only the surface layer portion 42 of the sheet member 32 melts and disappears, so that the fine concavo-convex structure 100 formed on the inner surface of the base portion 41 is exposed. In this way, the fine concavo-convex structure 100 can be expressed by dissolving the surface layer portion 42 with the solvent 70, that is, dissolving at least a part of the inner surface of the sheet member 32.

  Specifically, as shown in FIG. 8 (e), a predetermined solvent 70 is caused to flow from one end opening of the outer tube 22 in which the sheet member 32 is integrated, so that the solvent 70 reaches the surface layer portion 42 ( (See arrow 53 in FIG. 8 (e)). When the solvent 70 reaches the surface layer portion 42, as described above, only the surface layer portion 42 of the sheet member 32 melts and disappears, whereby the fine concavo-convex structure 100 can be expressed on the inner surface of the base portion 41.

  As another embodiment, the sheet member 32 includes a surface layer portion 42 having a melting point lower than that of the base portion 41. Specifically, the base portion 41 has a predetermined melting point (hereinafter referred to as “first melting point”), while the surface layer portion 42 has a melting point lower than the melting point of the base portion 41 (hereinafter referred to as “second melting point”). The melting point of.). Details will be described below.

  The sheet member 32 is heated at a predetermined temperature that is higher than the second melting point and lower than the first melting point. Since this predetermined temperature is higher than the second melting point, the surface layer portion 42 can be melted by heating. On the other hand, since the predetermined temperature is lower than the first melting point, the base portion 41 is not melted. Only the surface layer portion 42 of the sheet member 32 melts and disappears, so that the fine concavo-convex structure 100 formed on the inner surface of the base portion 41 is exposed. In this way, the surface layer portion 42 may be melted by heating, and the fine concavo-convex structure 100 may be developed on the inner surface of the base portion 41.

  For example, among the constituent materials of the tube body 2 described above, polyethylene terephthalate having a relatively high melting point (melting point: about 250 degrees) is used as a constituent material for the base portion 41, and polystyrene having a relatively low melting point (melting point: about 100 degrees) is used. The constituent material of the surface layer portion 42 can be used. Then, the sheet member 32 integrated with the outer tube 22 is heated at a temperature higher than the second melting point (100 degrees) and lower than the first melting point (250 degrees), for example, 175 degrees as the predetermined temperature. . When the sheet member 32 is heated at such a temperature, the surface layer portion 42 composed of polystyrene melts and disappears, while the base portion 41 composed of polyethylene terephthalate remains undissolved. In this way, the fine concavo-convex structure 100 can be expressed on the inner surface of the base portion 41. However, the first melting point and the second melting point need only be in the above relationship, and the constituent material of the base portion 41 and the constituent material of the surface layer portion 42 are not limited to the above-described materials. For example, the heat source is disposed outside the outer tube 22, and the sheet member 32 is heated from the outside of the outer tube 22.

  Here, in the case of the method of expressing the fine concavo-convex structure 100 using the difference in melting point between the base portion 41 and the surface layer portion 42, the step (P3) of integrating the sheet member 32 on the inner surface of the outer tube 22 described above. The step (P5) of melting at least a part of the inner surface of the sheet member 32 and developing the fine concavo-convex structure 100 can be performed simultaneously. That is, by heating at a predetermined temperature from the outside of the outer tube 22, the outer tube 22 is reduced in diameter, and the inner surface of the outer tube 22 is brought into close contact with the outer surface of the sheet member 32. In addition to being integrated, the surface layer portion 42 can be melted to develop the fine concavo-convex structure 100. In this case, the predetermined temperature is higher than the second melting point and lower than the first melting point, and the outer tube 22 is contracted so that the inner surface of the outer tube 22 and the outer surface of the sheet member 32 can be in close contact with each other. Let it be temperature.

<Step of forming fluorine coating layer 200 on the surface of fine concavo-convex structure 100 (P6)>
Next, the process (P6) of forming the fluorine coat layer 200 on the surface of the fine concavo-convex structure 100 will be described. Fluorine coating is applied to the surface of the fine concavo-convex structure 100 formed on the surface of the sheet member 32 to form the fluorine coat layer 200. This will be specifically described. First, the sheet member 32 on which the fine concavo-convex structure 100 is formed is prepared. Next, the fluorine coating agent containing the fluororesin described above is applied to the surface of the fine concavo-convex structure 100. As a method for applying the fluorine coating agent, dip coating in which the sheet member 32 is immersed in a solvent containing the fluorine coating agent is preferable. However, the present invention is not limited to dip coating. For example, a method in which a solvent containing a fluorine coating agent is dropped on the surface to spread the entire region where the fine uneven structure 100 is formed, or the fine uneven structure 100 is formed by spraying. A method of spraying on the formed surface or a method of applying to the surface on which the fine concavo-convex structure 100 is formed using a gutter member may be used. Next, the sheet member 32 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 surface. As an example of an aspect of curing the fluorine coating agent, for example, the sheet member 32 can be put in 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 to the surface of the fine concavo-convex structure 100, the water repellency, oil repellency and friction resistance of the surface of the sheet member 32 can be improved, and the strength of the fine concavo-convex structure 100 formed on the surface is improved. Can be made.

  As described above, a tube material having the fine concavo-convex structure 100 on the inner surface 31 can be formed, and the tube body 2 as a medical tube can be manufactured by performing various processes on the tube material. However, the tube material itself formed by the above-described steps (P1) to (P5) can be a different medical tube from the tube body 2.

  In addition, although the core rod member 50 is utilized in the process (P1)-the process (P3) in the manufacturing method of the tube main body 2 mentioned above, the core rod member 50 is not used for the process (P1)-the process (P3). It is also possible to do this. In such a case, the above-described step (P4) becomes unnecessary. However, if the above-described steps (P1) to (P3) are performed using a member disposed inside the bent sheet member 32 such as the core rod member 50, the steps (P1) to ( P3) can be executed more easily.

  In the above-described embodiment, an example in which the sheet member 32 is used as the thin member has been described, but an inner tube may be used as the thin member. In this case, in the manufacturing method described above, the step (P1) of bending the sheet member 32 becomes unnecessary. However, instead of this step (P1), a step of inserting a core rod member into the inner tube may be performed in order to facilitate the step (P2) and the step (P3). When the step of inserting the core rod member into the inner tube is performed, the other steps (P2) to (P5) have the same contents as those described above, except that the sheet member is replaced with the inner tube. It is.

  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.

  Further, for example, in the above-described embodiment, the bent sheet member or the thin tube member that is the inner tube and the outer tube are both configured by one layer (single layer), but each is configured by a plurality of layers. It may be a thing.

  In the drawings, for convenience of explanation, the thickness of the sheet member with respect to the width and length of the sheet member is drawn thick, but it should be noted that it is actually thinner.

  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 22: Outer tube 31: Inner surface 32 of tube main body: Sheet member (thin member)
41: Base portion 42: Surface layer portion 50: Core rod members 51, 52, 53: Arrow 70: Solvent 100: Fine uneven structure 101: Convex rib 102: Concave groove 103: Protrusion 105: Top surface 200: Fluorine coat layer A: Direction of central axis of inner peripheral surface of tube body B: Circumferential direction of tube body O1: Center axis of inner peripheral surface of tube body X: Foreign matter

Claims (7)

A method of manufacturing a medical tube having a fine concavo-convex structure on the inner surface,
Inserting a thin sheet member that is a bent sheet member or an inner tube into the outer tube;
Integrating the thin member with the inner surface of the outer tube;
Melting the at least part of the inner surface of the thin-walled member to develop the fine concavo-convex structure. The thin-walled member is formed with the fine concavo-convex structure on the inner surface and is insoluble in water or a predetermined solvent which is a predetermined organic solvent, and a surface layer portion provided on the fine concavo-convex structure and soluble in the predetermined solvent And comprising
The manufacturing method of the medical tube of Claim 1 which melts the said surface layer part with the said predetermined solvent, and expresses the said fine concavo-convex structure.   The method for producing a medical tube according to claim 2, wherein the predetermined solvent is allowed to reach the surface layer portion by flowing from one end opening of the outer tube integrated with the thin-walled member. The thin-walled member includes a base portion in which the fine concavo-convex structure is formed on the inner surface, and a surface layer portion provided on the fine concavo-convex structure and having a melting point lower than that of the base portion,
The manufacturing method of the medical tube of Claim 1 which melts the said surface layer part by heating and expresses the said fine concavo-convex structure.   By heating from the outside of the outer tube, the outer tube is reduced in diameter, the inner surface of the outer tube is in close contact with the outer surface of the thin member, and the thin member and the outer tube are integrated. Item 5. A method for producing a medical tube according to any one of Items 1 to 4. The thin-walled member includes a base portion in which the fine concavo-convex structure is formed on the inner surface, and a surface layer portion provided on the fine concavo-convex structure and having a melting point lower than that of the base portion,
By heating from the outside of the outer tube, the outer tube is reduced in diameter, the inner surface of the outer tube is in close contact with the outer surface of the thin member, and the thin member and the outer tube are integrated, The manufacturing method of the medical tube of Claim 1 which melts the said surface layer part and expresses the said fine uneven structure.   The manufacturing method of the medical tube as described in any one of Claims 1-6 which further includes the process of giving a fluorine coating to the said expressed fine uneven structure.

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