JP6717626B2 - Medical tube manufacturing method and medical tube - Google Patents

Description

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

Conventionally, for patients who have difficulty breathing spontaneously or who have difficulty discharging sputum by themselves, it is possible to directly connect the outside of the body to the trachea to establish an airway and to inhale foreign substances such as breath and sputum. Various tracheal tubes are known.

Such a tracheal tube is disclosed in Patent Document 1, for example. Specifically, in Patent Document 1, a lumen body having a lumen for securing an airway that penetrates from a proximal end portion to a distal end portion, a connector portion formed at a 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 is capable of expansion and contraction, and a cuff inflation lumen that is formed in a wall portion that constitutes the lumen body and that communicates the surface portion of the connector portion with the inside of the cuff, Disclosed is a tracheostomy tube including a suction lumen formed on a wall forming a lumen body and allowing a surface portion of the connector portion and a surface portion of the lumen body to communicate with each other.

In the tracheal tube disclosed in Patent Document 1, by forming a suction lumen in the wall of the lumen body that communicates from the surface of the connector section to a predetermined portion on the surface of the lumen body, and sucking from the connector section side, The sputum accumulated between the lumen body and the trachea can be discharged to the outside through the suction lumen.

Further, in the tracheal tube disclosed in Patent Document 1, a film that exhibits surface lubricity when wet is formed on the surface of the tracheotomy tube and the inner surface that forms the lumen for securing the airway of the lumen body. It is characterized by With this structure, when the inner surface of the luminal body becomes wet due to the breath or brim of the patient breathing, surface lubricity is developed, and sputum or the like adheres to the inner surface of the luminal body. It is stated that it will be difficult.

JP, 2006-102099, A

However, as far as the inventors of the present invention have studied, it was found that the tracheostomy tube described in Patent Document 1 leaves room for further improvement with respect to the suppression of sputum adhesion. Further, with respect to medical tubes used in addition to the tracheal tube, there is room for further improvement in suppressing the adhesion of biological substances such as sputum or medical liquids such as infusions.

Therefore, an object of the present invention is to provide a method for manufacturing a medical tube and a medical tube in which a biological substance or a medical liquid does not easily adhere.

The method for producing a medical tube according to the first aspect of the present invention includes an inner layer constituted by one layer or a plurality of layers constituting an inner peripheral surface on which a fine concavo-convex structure is formed, and one layer radially outward from the inner layer. Or a method of manufacturing a medical tube comprising an outer layer composed of a plurality of layers, wherein a sheet member forming the inner layer is inserted into an outer tube forming at least a layer of the outer layer to be laminated on the inner layer. And a step of integrating the sheet member and the outer tube in a state where the sheet member is inserted into the outer tube.

Further, it is preferable that the sheet member is bent into a cylindrical shape so that the surface on which the fine concavo-convex structure is formed becomes an inner surface, or the sheet member is folded and inserted into the outer tube.

Further, it is preferable that one end of the sheet member is fixed to a fixing jig to fix the shape of the sheet member and insert the sheet member into the outer tube.

Further, it is preferable that the method further includes a step of joining both ends of the sheet member to make the sheet member into a tube shape in a state where the sheet member is inserted into the outer tube.

Further, it is preferable that the both ends of the sheet member are joined by externally heating the both ends.

Further, in a state in which the sheet member is integrated with the outer tube, by inserting a curved rod member, at least a part of which is curved, into the sheet member, the sheet member and the outer side along the curved rod member. It is preferable to bend at least part of the tube.

Moreover, it is preferable that at least a part of the sheet member and the outer tube is curved by applying a force from the outside of the outer tube in a state where the sheet member is inserted into the outer tube.

Further, it is preferable that the sheet member and the outer tube are integrated with each other in a state where the shape maintaining jig is located inside the sheet member.

Further, in a state where the sheet member is inserted into the outer tube, by heating from the outside, the outer tube is reduced in diameter and the outer surface of the sheet member is brought into close contact with the inner surface of the outer tube, so that the sheet member is And the outer tube is preferably integrated.

Further, it is preferable that the method further includes a step of applying fluorine coating to the fine concavo-convex structure.

In the medical tube according to the second aspect of the present invention, the distance between the centers of the convex portions is 10 μm to 100 μm, and the maximum width of the top surface of the convex portions is 0.01 μm to 50 μm, and A fine concavo-convex structure having a maximum height of several μm to several hundred μm is formed on the inner surface, and the surface of the fine concavo-convex structure is coated with fluorine.

According to the manufacturing method of the present invention, it is possible to manufacture a medical tube in which a biological substance or medical liquid is less likely to adhere. Further, according to the medical tube of the present invention, it is possible to make it difficult for biological substances or medical liquids to adhere.

It is a figure which shows the state which left 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. 1 alone. It is an expanded sectional view which shows the fine grooving|roughness 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. FIG. 3 is a sectional view of the tube body shown in FIG. 2 in a direction perpendicular to the central axis direction. It is the figure which expanded a part of developed view of the inner peripheral surface of the inner layer 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 treatment tube as one Embodiment of this invention. It is a figure which shows transfer of the fine grooving|roughness structure by a metal mold. FIG. 8A is a diagram showing a state immediately before the die is pressed against the sheet member. FIG. 8B is a diagram showing a state in which the mold is pressed against the sheet member. FIG. 8C is a diagram showing a sheet member to which the fine concavo-convex structure is transferred. It is a figure explaining the method of bending a sheet member. FIG. 9A is a diagram showing a direction in which the sheet member is bent. FIG. 9B is a diagram showing a sheet member bent into a cylindrical shape. FIG. 9C is a diagram showing a method of bending a sheet member using a core rod jig. It is the figure which looked at the sheet member bent in the shape of a cylinder from the direction perpendicular to the long axis. It is the figure seen from the direction perpendicular to the direction which inserts the folded sheet member. It is a figure which shows the usage example of a fixing jig. FIG. 12A is a diagram showing an example of fixing a sheet member bent into a cylindrical shape. FIG. 12B is a partial vertical cross-sectional view of FIG. It is a figure explaining joining of both ends of a sheet member. FIG. 14(a) shows an example in which the hollow portion partitioned into the tube body is divided into two. FIG. 14(b) shows an example in which grooves which are the original shapes of the first to third lumens are formed in the outer tube. FIG. 14C shows an example in which the first to third lumens are formed in the outer tube. It is a figure which shows the example which inserts an inner tube in an outer tube. It is a longitudinal cross-sectional view of an integrated sheet member and an outer tube in which a curved bar member at least a part of which is curved is inserted inside and a part of which is curved.

Hereinafter, an embodiment of a method for manufacturing a medical tube according to the present invention will be described with reference to FIGS. Here, as an example of the method for manufacturing a medical tube according to the present invention, a method for manufacturing a tube body as a medical tube used for a tracheal tube will be described. In the drawings, common members and parts are designated by the same reference numerals.

<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 diagram showing a state in which a tracheal tube 1 manufactured by using the method for manufacturing a medical tube according to an embodiment of the present invention is left in the trachea. FIG. 2 is a perspective view showing the tube body 2 as a medical tube in the tracheal tube 1 alone. FIG. 3 is an enlarged cross-sectional view of the tube body 2 shown in FIG. 2, showing a fine concavo-convex structure 100 formed on the inner surface of the tube body 2. FIG. 4 is a diagram of the tracheal tube 1 viewed from the proximal end side. As shown in FIG. 1, a tracheal tube 1 is attached to a tube body 2, a contractable and expandable cuff 3 attached to an 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 a direction in which a central axis O1 of an inner peripheral surface of the tube body 2 extends (hereinafter, simply referred to as “central axial direction A”). ), the cuff mounting portion 9 is continuous on the proximal end 6 side of the distal end portion 8 and the cuff 3 is mounted on the outer peripheral surface, the curved portion 10 is continuous on the proximal end 6 side of the cuff mounting portion 9, and the curved portion The base end portion 11 includes a base end portion 11 that is continuous with the base end 6 side of 10 and includes the base end 6.

The tube body 2 defines a hollow portion 7 penetrating from the tip 5 to the base 6 in the central axis direction A. Further, the tube main body 2 includes first to third lumens 12 to 14 formed in the wall and extending in the central axis direction A from the base end opening defined in the base end surface. The hollow portion 7 can secure an airway in a state where the tracheal tube 1 is inserted from the outside into the trachea and left indwelling. The first lumen 12 extends from the first proximal end opening 12a to the suction port provided on the proximal end 6 side of the cuff 3, and is located on the upstream side of the trachea relative to the cuff 3 indwelling in the trachea. It is used to aspirate and remove foreign matter X such as sputum, saliva, aspiration, blood, etc. accumulated on (jaw side). The second lumen 13 extends from the second proximal end opening 13a to the suction port provided on the distal end 5 side of the cuff 3, and is located on the downstream side of the trachea (tracheal branch) relative to the cuff 3 left in the trachea. (Part side), it is used to suck and remove the foreign matter X such as sputum accumulated near the tip portion 8. The third lumen 14 extends from the third base end opening 14a to the communication port 14b provided at the position of the cuff 3, and is used for contracting and expanding the cuff 3. Note that the small-diameter first to third lumens 12 to 14 partitioned in the wall are also hollow portions, but for convenience of description, in order to distinguish from the large-diameter hollow portion 7 for securing the airway, here, Described as "lumen".

As shown in FIG. 3, a fine concavo-convex structure 100 is formed on the entire inner surface of the inner peripheral surface of the tube body 2 as a medical tube. The fine concavo-convex structure 100 has a surface having concavities and convexities of several μm to several hundred μm size, preferably several μm to several tens μm size. The fine concavo-convex structure 100 region has a property of suppressing the attachment of sputum (hereinafter, referred to as “sputum repellency”). The details of the method for forming the fine concavo-convex 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.

Further, a fluorine coating layer 200 is formed on the surface of the fine concavo-convex structure 100. The fluorine coating layer 200 is not particularly limited as long as it has a fluorine resin as a main component. Examples of the fluororesin include polytetrafluoroethylene (PTFE), polychlorotrifluoroethylene (PCTFE, CTFE), polyvinylidene fluoride (PVDF), polyvinyl fluoride (PVF), perfluoroalkoxy fluororesin (PFA), and tetrafluorine. Ethylene/hexafluoropropylene copolymer (FEP), ethylene/tetrafluoroethylene copolymer (ETFE), ethylene/chlorotrifluoroethylene copolymer (ECTFE) and the like can be used.

Examples of the constituent material of the tube body 2 include silicone, polyvinyl chloride such as 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, 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) from the viewpoint of easy molding.

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

The flange member 4 is attached to the base end portion 11 (see FIG. 2) of the tube body 2 as shown in FIG. 1, and when the tube body 2 is inserted from the outside of the body into the trachea and the tracheal tube 1 is placed. , The tip portion 8 is fixed to 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 mounted on the tube body 2 by inserting the base end portion 11 of the tube body 2 and fitting the tube body 2 in the flange member 4. A portion 17 and a plate-like flange portion 18 that projects radially outward from the outer wall of the tubular portion 17 and abuts the skin when the tracheal tube 1 is left in place. Note that, in FIG. 4, for convenience of description, the positions of the first lumen 12, the second lumen 13, and the third lumen 14 of the tube body 2 are indicated by alternate long and two short dashes lines.

As shown in FIG. 4, in the tubular portion 17, communication holes 17a and 17b that communicate with the above-described first lumen 12, second lumen 13 and third lumen 14, respectively, at positions closer to the base end side than the flange portion 18. , 17c are sectioned. In a state in which the base end portion 11 of the tube body 2 is fitted into the tubular portion 17 by being fitted, the first lumen 12, the second lumen 13 and the third lumen 14 have corresponding communication holes 17a, 17b, 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 the corresponding communication hole 17a formed in the tubular portion 17. Therefore, if a syringe or a suction pump is connected to the other end of the suction tube 19a as a medical tube having one end fitted in the communication hole 17a of the cylindrical portion 17 exposed to the outside of the body to perform suction, The foreign substance X such as sputum can be sucked through the first lumen 12. The second lumen 13 is also similar to the first lumen 12, and the foreign substance X is sucked through the suction tube 19b as a medical tube, the corresponding communication hole 17b formed in the tubular portion 17, and the second lumen 13. can do.

Furthermore, 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 17c formed in the tubular portion 17. Therefore, if a syringe or the like is connected to the other end of the cuff tube 19c as a medical tube having one end fitted to the communication hole 17c of the cylindrical portion 17 exposed to the outside of the body, by operation of the syringe or the like outside the body, The fluid can be supplied to and suctioned from the annular space of the cuff 3, whereby the expansion and contraction of the cuff 3 can be manipulated.

The tubular portion 17 of the flange member 4 is mounted concentrically with the base end portion 11 of the tube body 2, and the position of the first lumen 12 and the position of the second lumen 13 in the circumferential direction B of the tube body 2, The positions of the third lumen 14 and the third lumen 14 are near the positions of the corresponding communicating holes 17a, 17b, and 17c of the tubular portion 17 in the circumferential direction B. Therefore, the communication holes 17a, 17b, 17c can be shortened, and the complication of the structure of the communication holes 17a, 17b, 17c of the tubular portion 17 can be suppressed. Further, as shown in FIG. 4, the suction tubes 19a and 19b and the cuff tube 19c are arranged in the direction in which the flange portion 18 is projected from the communication holes 17a, 17b, 17c in the plan view of FIG. It is connected so as to extend, and does not extend to the tip portion 8 side. By connecting in this way, in the state where the tracheal tube 1 is left in the trachea, the suction tubes 19a and 19b and the cuff tube 19c are prevented from hitting the patient's jaw or 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, the same material as that of the tube body 2 can be used.

<Method of manufacturing tube body 2>
Next, a method for manufacturing the tube body 2 as a medical tube will be described. FIG. 5 shows a sectional view of the tube body 2 as a medical tube in a direction perpendicular to the central axis direction A (see FIG. 2). Note that FIG. 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 exist in the central axis direction A of the tube body 2. As shown in FIG. 5, this manufacturing method is a manufacturing method of the tube body 2 as a medical tube including an inner layer 30 and an outer layer 40. The inner layer 30 is a single layer (single layer) and has an inner peripheral surface 31 on which the fine concavo-convex structure 100 as shown in FIG. 3 is formed. The inner layer 30 is composed of one layer or a plurality of layers. The outer layer 40 is provided radially outside the inner layer 30. Like the inner layer 30, the outer layer 40 is composed of one layer or a plurality of layers. The outer layer 40 of the present embodiment is composed of a plurality of layers including an innermost layer 41 (hereinafter, referred to as “inner layer 41”) that is laminated on the radially outer side of the inner layer 30. In addition, in FIG. 5, the boundary between the inner layer 41 and another layer or a plurality of layers located on the outer side in the radial direction of the inner layer 41 is indicated by a broken line. Further, as shown in FIG. 5, in the present embodiment, the inner layer 30 will be described as a single layer (single layer).

An example of the uneven pattern of the fine uneven structure 100 formed on the inner peripheral surface 31 of the inner layer 30 is shown. FIG. 6 is an enlarged view of a part of the developed view of the inner peripheral surface 31, in which the horizontal direction indicates the central axis direction A of the tube body 2 and the vertical direction indicates the circumferential direction B of the tube body 2. As described above, the fine concavo-convex structure 100 is a concavo-convex structure having a size of several μm to several hundreds of μm, preferably several μm to several tens of μm. The uneven structure may have 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 space structure"). Further, for example, as shown in FIG. 6B, a structure in which the truncated cone-shaped projections 103 are arranged in a predetermined array (hereinafter, simply referred to as a “pillar structure”) can be used. 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, the foreign matter X such as sputum on the surface having the 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 stays in the tube body 2. 6A in which the convex ribs 101 and the concave grooves 102 extend in the central axis direction A so that there is no such problem. Further, the shape of the protrusions 103 forming the pillar structure is not limited to the truncated cone shape, and may be a conical shape, a cylindrical shape, a triangular pyramid shape or another polygonal pyramid shape, a prismatic shape, or the like.

As described above, the fine concavo-convex structure 100 is a concavo-convex structure having a size of several μm to several hundreds of μm, preferably several μm to several tens of μm. The distance between the centers of the ribs 101 or the protrusions 103 in the pillar structure (hereinafter, the convex ribs 101 and the protrusions 103 are simply referred to as “convex portions”) is preferably 10 μm to 100 μm, and 10 μm to 50 μm. Is more preferable. If it is larger than 100 μm, sputum is likely to enter between the convex parts, and the effect of sputum repellency becomes small. On the other hand, when it is less than 10 μm, the contact area between the sputum and the convex portion becomes large, and the effect of sputum repellency becomes small.

Further, when the size of the fine concavo-convex structure 100 is under 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 even 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 sputum becomes large and the effect of sputum repellency becomes small. On the other hand, if it is less than 0.01 μm, it is difficult to form the convex portion, and the shape stability may be deteriorated. 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 protrusion is the maximum length of the top surface 105 in the direction orthogonal to the extending direction of the convex rib 101. It becomes

Further, the size of the fine concavo-convex structure 100 is set such that the maximum height of the convex portion of the fine concavo-convex structure 100 is several μm to several hundreds μm, preferably several μm to several tens μm.

Specifically, FIG. 7 shows a forming flow of the tube body 2 as a medical tube. This manufacturing method includes the step of forming the fluorine coating layer 200 on the surface of the fine concavo-convex structure 100 (P1), the sheet member 32 forming the inner layer 30 described above, and the layer laminated on the inner layer 30 among the outer layers 40. At least a step (P2) of inserting into the outer tube 22 to be formed (see FIG. 15 to be referred to later) and a step of integrating the sheet member 32 and the outer tube 22 with the sheet member 32 inserted into the outer tube 22. (P3) is included. When the outer layer 40 is composed of one layer, the outer tube 22 forms the entire outer layer 40. When the outer layer 40 is composed of a plurality of layers, the outer tube 22 is a layer laminated on the inner layer 30, that is, the innermost layer 41 (inner layer 41) of the outer layer 40 in the radial direction of the tube body 2. At least form (see FIG. 5). Hereinafter, the sheet member 32 and each of the above steps will be described in detail.

The sheet member will be described. The sheet member is a sheet-shaped member having a predetermined thickness. The thickness of the sheet member is preferably 0.1 mm to 1.0 mm, more preferably 0.15 mm to 0.5 mm. When the sheet member has a rectangular shape when viewed from the thickness direction, the length of the short side of the surface of the sheet member is set to be substantially equal to the inner circumference of the outer tube 22, and the length of the long side is set. Is equal to or longer than the length of the outer tube 22 in the axial direction. With this configuration, the sheet member can be provided inside the outer tube 22 over the entire area of the outer tube 22 in the axial direction and the entire area in the circumferential direction. However, the dimensions of the surface of the sheet member are not limited to those described above. For example, as will be described later, when the sheet member is inserted into the outer tube, the length of the short side of the surface of the sheet member is set to the outer tube. It may be longer than the inner diameter of the sheet, and the sheet members may be inserted into the outer tube so as to be doubled. Further, when the sheet member and the outer tube are integrated with each other, it is possible to make the outer diameter of the inner tube smaller than the inner diameter of the outer tube by using a method of shrinking the outer tube by heat. That is, the length of the short side of the surface of the sheet member may be shorter than the circumference of the outer tube 22.

As the constituent material of the sheet member, for example, the above-described constituent material of the tube body 2 such as soft polyvinyl chloride can be used.

FIG. 8 shows transfer of the fine concavo-convex structure 100 by the mold 50. The fine concavo-convex structure 100 can be formed by transfer with the mold 50 on which the fine concavo-convex pattern 52 is formed in advance. Specifically, as shown in FIG. 8A, the mold 50 is pressed against one surface 33 of the sheet member 32 (see the arrow 51 in FIG. 8A). A fine concavo-convex pattern 52 is formed on the surface of the die 50 that is pressed against the sheet member 32. The fine concavo-convex pattern 52 has a concavo-convex direction opposite to that of the fine concavo-convex structure 100 having a desired concavo-convex pattern formed on the sheet member 32. As shown in FIG. 8B, heating is performed in a state where the die 50 is pressed against the sheet member 32 (see the arrow 53 in FIG. 8B). By doing so, the fine concavo-convex pattern 52 of the die 50 is transferred to the surface 33 of the sheet member 32, and as shown in FIG. 8C, the fine concavo-convex pattern is opposite in direction to the fine concavo-convex pattern 52. Structure 100 is formed on surface 33 of sheet member 32.

[Step of forming the fluorine coating layer 200 on the surface of the fine concavo-convex structure 100 (P1)]
Next, the step (P1) of forming the fluorine coating layer 200 on the surface of the fine concavo-convex structure 100 will be described. The surface of the fine concavo-convex structure 100 formed on the surface 33 of the sheet member 32 is coated with fluorine to form the fluorine coating layer 200. This will be specifically described. First, the above-mentioned sheet member 32 having the fine concavo-convex structure 100 formed on the surface 33 is prepared. Next, the surface of the fine concavo-convex structure 100 is coated with the above-mentioned fluorine coating agent containing the fluorine resin. The method for applying the fluorine coating agent is preferably dip coating, in which the sheet member 32 is dipped in a solvent containing the fluorine coating agent. However, the method is not limited to dip coating, and for example, a method of dropping a solvent containing a fluorine coating agent onto the surface 33 to spread the solvent over the entire region where the fine concavo-convex structure 100 is formed, or spraying on the surface 33 by spraying. Alternatively, the surface 33 may be applied by a method or by using a spinning member. Next, the sheet member 32 is dried with the solvent containing the fluorine coating agent 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 33. As an example of a mode of curing the fluorine coating agent, for example, the sheet member 32 can be put into an oven (not shown) and heated in the oven at a predetermined temperature for a predetermined time to be cured. 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. Thus, the fluorine coating layer 200 is formed on the surface of the fine concavo-convex structure 100.

By applying fluorine coating to the surface of the fine concavo-convex structure 100, the water repellency, oil repellency, and abrasion resistance of the surface 33 of the sheet member 32 can be improved, and the strength of the fine concavo-convex structure 100 formed on the surface 33 can be improved. Can be improved. Therefore, when inserting the sheet member 32 into the outer tube 22, which will be described later, or when integrating the sheet member 32 and the outer tube 22 with the shape maintaining jig positioned inside the sheet member 32, the It is possible to make the uneven structure 100 less likely to be damaged.

[Step of inserting the sheet member 32 into the outer tube 22 (P2)]
Next, the step (P2) of inserting the sheet member 32 into the outer tube 22 will be described. FIG. 15 is a diagram showing an example of inserting the sheet member 32 into the outer tube 22. As shown in FIG. 15, the sheet member 32 is inserted into the outer tube 22 from one end to the other end of the outer tube 22. In the outer tube 22, the sheet member 32 is moved relative to the outer tube 22 to a predetermined position in the outer tube 22.

The sheet member 32 is deformed and inserted into the outer tube 22. As an example of a modified mode, for example, it can be bent into a cylindrical shape or folded. FIG. 9 is a diagram illustrating a method of bending the sheet member 32 into a cylindrical shape. Specifically, the sheet member 32 is bent into a cylindrical shape so that the surface 33 on which the fine concavo-convex structure 100 is formed is the inner surface. When the sheet member 32 is bent, as shown in FIGS. 9A and 9B, the end portions 34c and 34d of the end portion 34 of the sheet member 32 including the short side of the surface 33 are circular. Bend (see arrow 54 in FIG. 9A). FIG. 10 is a view of a sheet member bent into a cylindrical shape as seen from a direction perpendicular to the long axis, and is a view showing some examples of bending methods. Preferably, as shown in FIG. 10A, the end portions 34a and 34b including the long side of the surface 33 of the sheet member 32 are bent so as to abut against each other. On the other hand, as shown in FIG. 10B, a gap (see an arrow in FIG. 10B) is provided between one end 34a and the other end 34b of the surface 33 of the sheet member 32 including the long side. You may bend. Preferably, the gap is 1 mm or less. Further, as shown in FIG. 10(c), there may be a double overlapping portion, and as shown in FIG. 10(d), it may be bent so as to have a triple or more overlap. In addition, in FIG. 10C, a portion where the sheet member 32 is doubly overlapped is shown by a broken line circle.

Preferably, when bending the sheet member 32 into a cylindrical shape, as shown in FIG. 9C, for example, a cylindrical core rod jig 57 is used, and the sheet member 32 is wound around the outer surface of the core rod jig 57. Bend into a cylindrical shape according to the shape of the outer surface of 57. Specific examples of the core rod jig 57 include solid or hollow metal rods and resin rods. In addition to this, specific examples of the core rod jig 57 include elastic members such as a self-expanding reticulated tubular member, a spiral or spiral spring member, and an expandable body such as a balloon expandable by air pressure or water pressure. ..

FIG. 11 is a view seen from a direction perpendicular to the direction of inserting the folded sheet member. As an example of the folding method, as shown in FIG. 11, the sheet member 32 is folded so that a cross section perpendicular to the direction in which the sheet member 32 is inserted into the outer tube 22 (hereinafter, referred to as “insertion direction”) has a concave shape. be able to. By doing so, the outer diameter of the cross section perpendicular to the insertion direction of the seat member 32 can be made smaller than the inner diameter of the outer tube 22, so that the seat can be easily inserted into the outer tube 22 and the seat having the concave shape is formed. Since the member 32 easily returns to the cylindrical shape due to the restoring force, it is easy to return the sheet member 32 to the shape along the inner surface of the outer tube 22 after being inserted into the outer tube 22. However, the seat member 32 can be inserted into the outer tube 22, and the seat member 32 and the outer tube 22 are integrated with each other in a state where the seat member 32 is inserted into the outer tube 22, so that the inner peripheral surface 31 of the tube body 2 is desired. Any folding method may be used as long as the fine concavo-convex structure 100 can be arranged at the position.

Preferably, by fixing one end of the sheet member 32 to a fixing jig, the shape of the sheet member 32 is fixed and the sheet member 32 is inserted into the outer tube 22. FIG. 12 shows an example of using the fixing jig. In FIG. 12, the above-mentioned core rod jig 57 is used as it is as the fixing jig, but another fixing jig may be used instead of the core rod jig 57. As shown in FIGS. 12A and 12B, a cap member 84 capable of fixing the sheet member 32 to the core rod jig 57 is provided at one end of the core rod jig 57 as a fixing jig. .. The cap member 84 defines therein a cylindrical hole 85 having a diameter slightly smaller than or about the same as the diameter of the core rod jig 57. Therefore, when one end of the core rod jig 57 is fitted into the hole 85 of the cap member 84, the inner surface defining the hole 85 is brought into close contact with the outer surface of the core rod jig 57.

As shown in FIGS. 12A and 12B, one end portion of the sheet member 32 in the insertion direction of the sheet member 32, that is, the end portion on the front end side is provided with the outer surface of the core rod jig 57 and the hole 85 of the cap member 84. The sheet member 32 can be fixed to the core rod jig 57 in a cylindrically bent state by sandwiching the sheet member 32 with the inner surface to be partitioned. By doing so, one end of the sheet member 32 bent into a cylindrical shape can be fixed to the core rod jig 57 as a fixing jig. Here, when one end of the core rod jig 57 is fitted in the hole 85 of the cap member 84, the outer diameter of the cap member 84 is larger than the outer diameter of the sheet member 32 wound around the core rod jig 57. Small or almost equal. In the present embodiment, as shown in FIGS. 9C and 12B, one end of the core rod jig 57 fitted in the hole 85 of the cap member 84 has a tapered shape in which the diameter is reduced toward the tip side. By doing so, this is achieved.

The configuration of the cap member 84 is not limited to the configuration shown in FIGS. 12A and 12B as long as the sheet member 32 can be fixed to the fixing jig in a deformed state. For example, the cap member 84 shown in FIGS. 12A and 12B is attached to the core rod jig 57 at the tip end side in the insertion direction of the sheet member 32, and is placed inside the outer tube 22 together with the sheet member 32 and the core rod jig 57. Although it is inserted, a cap member that is attached to the core rod jig 57 on the rear end side in the insertion direction of the sheet member 32 and is not inserted into the outer tube 22 may be used. Further, when the cap member 84 is used without being inserted into the outer tube 22, the cap member 84 may have an outer diameter larger than the outer diameter of the sheet member 32 when wound around the core rod jig 57. Good.

As described above, by fixing the sheet member 32 to the fixing jig, the shape of the sheet member 32 can be fixed and the sheet member 32 can be inserted into the outer tube 22. By using the fixing jig, the sheet member 32 can be fixed to the outer tube 22 in a shape that allows easy insertion, and the shape can be maintained while being inserted into the outer tube 22, so that the sheet member 32 can be easily inserted. .. Further, when the sheet member 32 is fixed to the fixing jig, the sheet member 32 can be moved with respect to the outer tube 22 only by the relative movement of the fixing jig and the outer tube 22, and the sheet member 32 is fixed. The seat member 32 can be inserted into the outer tube 22 more smoothly than when not fixed to the outer tube 22.

Preferably, in a state where the sheet member 32 is inserted into the outer tube 22, both ends 34a and 34b of the sheet member 32 are joined to each other to form the sheet member 32 into a tube shape. Specifically, as shown in FIG. 13, in the sheet member 32, both ends 34a and 34b from the outside of the outer tube 22 are abutted with the opposite ends 34a and 34b including the long side of the surface 33 but facing each other. Both ends 34a and 34b are melted and welded by heating. Preferably, the laser irradiation 56 is performed from the outside of the outer tube 22 toward both ends 34a and 34b. The laser is irradiated from a position separated by a predetermined distance so that both ends 34a and 34b of the sheet member 32 inserted in the outer tube 22 are focused. By the laser irradiation 56, heat is applied to both end portions 34a and 34b of the sheet member 32, and both end portions 34a and 34b are melted and welded. In addition to laser light, other known techniques such as electricity, high frequency, and ultrasonic waves can be used for the heat source.

The welding may be performed in a state where the core rod jig 57 described above is inserted inside the sheet member 32. In this case, a part or all of the core rod jig 57 is made of a material having good thermal conductivity, and the core rod jig 57 is externally heated or heated to be wound around the core rod jig 57 via the core rod jig 57. Alternatively, the end portions 34a and 34b of the sheet member 32 that is being heated may be heated and welded. As the material having good thermal conductivity, a metal such as aluminum or copper can be used. Further, instead of the above-mentioned core rod jig 57, another member is inserted inside the sheet member 32, and by heating or heating this member from the outside, the end portions 34a and 34b of the sheet member 32 are heated, You may make it weld.

[Step of integrating the sheet member 32 and the outer tube 22 (P3)]
Next, the step (P3) of integrating the sheet member 32 and the outer tube 22 will be described. When 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 wave 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.

The outer tube 22 of the present embodiment is made of a material having a property of being softened by heating from the outside, that is, a material having thermoplasticity, among the constituent materials of the tube body 2 described above. The outer tube 22 contracts due to heating from the outside. Therefore, the outer tube 22 is reduced in diameter by being heated from the outside, 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”). It is described as.). In this way, the outer tube 22 is attached and fixed to the outer surface of the sheet member 32, so that the sheet member 32 and the outer tube 22 are integrated. Further, the inner surface of the outer tube 22 and the outer surface of the sheet member 32 may be melted and welded together to more firmly integrate the outer tube 22 and the sheet member 32.

Preferably, the sheet member 32 and the outer tube 22 are integrated with each other while the shape maintaining jig is positioned inside the sheet member 32. As the shape maintaining jig, for example, the core rod jig 57 described above can be used. The sheet member 32, the core rod jig 57, and the outer tube 22 are put into an oven and heated while the core rod jig 57 as the shape maintaining jig is still inserted inside the sheet member 32. By positioning the core rod jig 57 inside the sheet member 32 during heating, when the outer tube 22 is reduced in diameter, the sheet member 32 is directed radially inward from the state along the inner surface of the outer tube 22. It is possible to suppress the deformation. Therefore, the outer tube 22 and the sheet member 32 can be more firmly integrated with each other, and the cross-sectional shape of the manufactured tube body 2 (see FIG. 2) can be made more uniform. Although the core rod jig 57 used when the sheet member 32 is formed into a cylindrical shape is used as a shape maintaining jig as it is here, another core rod jig or the like is used instead of the core rod jig 57. The jig or the like may be inserted into the inside of the sheet member 32 as a shape maintaining jig and heated together with the sheet member 32 and the outer tube 22.

In the above example, the integration by heating from the outside has been described, but the invention is not limited to this, and a method of integrating the sheet member 32 and the inner surface of the outer tube 22 with a solvent or an adhesive may be used. Good. As the adhesive, an instant 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.

As described above, the sheet member 32 and the outer tube 22 are integrated to form a tube material, and the tube body 2 as a medical tube is formed by subjecting the tube material to various processes. You can When the shape maintaining jig such as the core rod jig 57 is used for heating, the shape maintaining jig such as the core rod jig 57 is removed after the sheet member 32 and the outer tube 22 are integrated. The material is formed to form the tube body 2 as a medical tube. Alternatively, the tube body 2 may be formed by cutting both ends.

Although the steps (P1) to (P3) in the method for manufacturing the tube body 2 described above include the step of forming the fluorine coating layer 200 in the step (P1), it should be performed without using this step. Is also possible. In such a case, the step (P1) described above is unnecessary. In addition, although the example of applying the fluorine coating to the surface of the fine concavo-convex structure 100 formed on the surface 33 of the sheet member 32 has been described, the present invention is not limited to this, and is performed after the sheet member 32 is inserted into the outer tube 22. Alternatively, it may be performed after the sheet member 32 is integrated with the outer tube 22, or may be performed after the tube described below is bent. However, if the step (P1) of forming the fluorine coating layer 200 described above is included, the strength of the fine concavo-convex structure 100 can be further improved.

Preferably, as shown in FIG. 16, when the sheet member 32 is integrated with the outer tube 22, the bending rod member 90, at least a part of which is curved, is inserted into the inside of the sheet member 32 to thereby bend the bending rod member. At least a portion of the seat member 32 and the outer tube 22 is curved along 90. By doing so, the curved portion 10 (see FIG. 2) of the tube body 2 can be formed. It should be noted that the sheet member 32 and the outer tube 22 are heated in the oven and then cooled in a state where the curved rod member 90 at least a part of which is curved is inserted inside the sheet member 32. By doing so, the tube body 2 having a curved shape can be created. Further, in the present embodiment, the curved rod member 90 is inserted into the sheet member 32 such that the curved portion of the curved rod member 90 is arranged on one side of the sheet member 32 and the outer tube 22. By doing so, the curved portion 10 of the tube body 2 shown in FIG. 2 can be formed. The curved rod member 90 shown in FIG. 16 uses a curved rod member 90 having an outer diameter smaller than the inner diameter of the outer tube 22 so as not to break the fine concavo-convex structure 100 formed on the surface 33 of the sheet member 32. There is.

A method of bending at least a part of the sheet member 32 and the outer tube 22 without using the bending rod member 90 may be used. Specifically, in a state where the seat member 32 is inserted into the outer tube 22, by applying a force from the outside of the outer tube 22, at least a part of the seat member 32 and the outer tube 22 inserted into the outer tube 22 is removed. To bend. In this way, the curved portion 10 (see FIG. 2) of the tube body 2 may be formed. As a method of applying a force from the outside of the outer tube 22, for example, a mold having at least a part of the sheet member 32 and the outer tube 22 and having a receiving surface that can be maintained in a desired posture can be used. In addition to the use of such a mold, a core rod that is linear inside the sheet member 32 and deformable by applying an external force when the sheet member 32 is inserted into the outer tube 22. You may make it insert a member. That is, in the state where the sheet member 32 is inserted into the outer tube 22, the linear core rod member is inserted inside the sheet member 32, the core rod member is curved after the insertion, and then the die is used to By fixing the curved state from the outside, a tube body having a curved portion at least in part may be formed. The bendable core rod member may be formed of a flexible silicone resin or shape memory alloy. Such a deformable core rod member may be configured by the core rod jig 57 described above.

Although the above-mentioned tube body 2 has one hollow portion 7, it is also possible to create a tube body having a plurality of hollow portions formed therein. As shown in FIG. 14( a ), two sheet members 32 bent into a cylindrical shape are inserted into the outer tube 22 to integrate the two sheet members 32 and the outer tube 22, and at the same time, the two sheet members 32. Integrate each other. By doing so, it is possible to form a tube body in which the hollow portion of the tube body 2 is divided into the first hollow portion 7a and the second hollow portion 7b.

Next, a method for forming the first to third lumens 12 to 14 of the tube body 2 described above will be described as an example. As shown in FIG. 14B, three grooves 43a, 43b, 43c are defined in the inner wall 42 of the outer tube 22. The three grooves 43a, 43b, 43c extend in the central axis direction A of the outer tube 22 from one end to the other end of the outer tube 22. The sheet member 32 is inserted into the outer tube 22 to integrate the sheet member 32 and the outer tube 22. When the seat member 32 and the outer tube 22 are integrated with each other, the inner wall 42 of the outer tube 22 defining the three grooves 43a, 43b, 43c and the outer surface of the seat member 32 penetrate from one end to the other end. -Three hollow parts which become the original form of the 3rd lumen 12-14 are formed. In addition to this, as shown in FIG. 14( c ), the outer tube 22 is composed of a plurality of layers, and the innermost layer in the radial direction to be the inner layer 41 (see FIG. 5) described above is first to first It may be a layer in which three hollow portions which are the original shapes of the three lumens 12 to 14 are formed. Furthermore, when the outer tube 22 is composed of a plurality of layers, the outer tube 22 is not limited to the innermost layer shown in FIG. You may form three hollow parts used as an original form.

The method for producing a medical tube and the medical tube according to the present invention are not limited to the specific methods and configurations described in the above embodiments, and do not deviate from the gist of the invention described in the claims. Thus, various changes can be made. For example, in the above-described embodiment, the method of manufacturing the tube body 2 as a medical tube has been described, but the method of manufacturing the tube according to the present invention is not limited to the tube body of the tracheal tube, and is used for other purposes and purposes. It can also be applied as a method for producing a medical tube.

Examples of medical tubes that can be manufactured by the manufacturing method according to the present invention include (1) gastric tube catheters, feeding catheters, tube feeding tubes, etc. that are inserted or left in the digestive organs orally or nasally. Catheter; (2) Oxygen catheter, endotracheal tube, endotracheal suction catheter, or other catheter orally or nasally inserted or placed in the airway or trachea; (3) Urethral catheter, urinary catheter, urethral balloon Catheter, such as catheter or balloon, which is inserted or left in the urethra or ureter; (4) Catheter, which is inserted or left in various body cavities, organs, tissues such as suction catheter, drainage catheter, rectal catheter; (5) Indirect or direct insertion or placement in blood vessels such as infusion tubes, IVH (abbreviation of intravenous hyperalimentation) catheters, thermodilution catheters, angiography catheters, vasodilation catheters and dilators or introducers. Catheters to be used; (6) medical artificial tubes such as artificial trachea and artificial bronchus; (7) circuits of medical instruments (artificial lung, artificial heart, artificial kidney, etc.) for extracorporeal circulation treatment.

The various medical tubes manufactured by the manufacturing method according to the present invention can prevent a wide range of biological substances or medical liquids from adhering to the inner surface. The "biological substance" includes, for example, whole blood, plasma, serum, sweat, stool, urine, saliva, tears, vaginal fluid, prostatic fluid, gingival exudate, amniotic fluid, ocular fluid, cerebrospinal fluid, semen. , Sputum, ascites, pus, nasopharyngeal fluid, wound exudate, aqueous humor, vitreous humor, bile, earwax, endolymph, perilymph, gastric juice, mucus, ascites, pleural effusion, sebum, vomit, combinations thereof , And so on. In addition, examples of the "medical liquid" include infusions, nutrients, contrast agents, embolic agents used in hepatic arterial chemoembolization (TACE), and the like.

In the drawings, the thickness of the sheet member is drawn thicker than the width and length of the sheet member for convenience of description, but it should be noted that it is actually thinner.

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

1: Tracheal tube 2: Tube body (medical tube)
3: Cuff 4: Flange member 5: Tip of tube body 6: Base end of tube body 7: Hollow part 7a of tube body: First hollow part 7b: Second hollow part 8: Tip part of tube body 9: Tube body Cuff mounting part 10: curved part 11 of tube body: base end part 12 of 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: tubular portions 17a, 17b, 17c: communication hole 18: flange portions 19a, 19b: suction tube 19c: cuff tube 22: outer tube 30: inner layer 31: inner peripheral surface 32 : Sheet member 33: Surfaces 34, 34a, 34b, 34c, 34d: End part 40: Outer layer 41: Innermost layer of the outer layer (inner layer)
42: Inner walls 43a, 43b, 43c: Groove 50: Molds 51, 53, 54: Arrow 52: Fine uneven pattern 56: Laser irradiation 57: Core rod jig (fixing jig, shape maintaining jig)
84: Cap member 85: Hole 90: Curved bar member 100: Fine concavo-convex structure 101: Convex rib 102: Concave groove 103: Protrusion 105: Top surface 200: Fluorine coating layer A: Direction of central axis of inner peripheral surface of tube body B: Circumferential direction of tube body O1: Central axis of inner peripheral surface of tube body X: Foreign matter

Claims (9)

Manufacture of a medical tube provided with an inner layer composed of one layer or a plurality of layers forming an inner peripheral surface on which a fine concavo-convex structure is formed, and an outer layer composed of one layer or a plurality of layers radially outside the inner layer. Method,
A resin sheet member that forms the inner layer, in a state of being cylindrically wound around a core rod jig such that the surface on which the fine concavo-convex structure is formed is an inner surface, together with the core rod jig, among the outer layers, Inserting into a resin outer tube forming at least a layer laminated to the inner layer,
Wherein in a state in which the sheet member is inserted into the outer tube, the said sheet member wound around the core rod jig, manufacturing process of the outer tube, a step of integrating the medical tube containing. One end of the cylindrical of the sheet member being wound around the mandrel jig while fixing to the core rod jig, inserting the sheet member and the core rod jig to the outer tube, according to claim 1 The method for manufacturing a medical tube according to. In a state where the sheet member is wound around the core rod jig and inserted into the outer tube,
The method for manufacturing a medical tube according to claim 1 or 2 , further comprising a step of joining both ends of the sheet member to form the sheet member into a tube shape. The method for manufacturing a medical tube according to claim 3 , wherein the both ends of the sheet member are joined by externally heating the both ends. The medical tube according to claim 4, wherein the metal core jig is heated or heated, and the both ends of the sheet member are joined to each other by heating the both ends of the sheet member via the core jig. Production method. In a state where the sheet member is integrated with the outer tube, by inserting a curved rod member, at least a part of which is curved, inside the sheet member,
The method for manufacturing a medical tube according to claim 1, wherein at least a part of the sheet member and the outer tube is curved along the curved rod member. In a state where the sheet member is inserted into the outer tube,
The method for manufacturing a medical tube according to claim 1, wherein at least a part of the sheet member and the outer tube is curved by applying a force from the outside of the outer tube. In a state where the sheet member is wound around the core rod jig and inserted into the outer tube,
By heating from the outside, the outer tube made of a thermoplastic resin is reduced in diameter, the inner surface of the outer tube is brought into close contact with the outer surface of the sheet member, and the sheet member and the outer tube are integrated. The method for producing the medical tube according to any one of claims 1 to 7 , which is made into a material. The method for manufacturing a medical tube according to any one of claims 1 to 8 , further comprising a step of applying a fluorine coating to the fine concavo-convex structure.

Images