Method for manufacturing composite tube for medical equipment, composite tube for medical equipment, and endoscope

Abstract

Provided is a method for manufacturing a composite tube for medical equipment having a curved region with a small bending radius. In the method for manufacturing a composite tube 2 for medical equipment, a cut C10 is formed in a first tube 10, the region of the first tube 10 where the cut C10 is formed is covered by a second tube 20 to form a WIP tube 2W, and the second tube 20, which is a heat-shrinkable tube, is heat-shrunk.

Description

Manufacturing method of composite tube for medical device, composite tube for medical device, and endoscope

[0001] The present invention relates to a method for manufacturing a composite tube for medical devices, a composite tube for medical devices, and an endoscope having a composite tube for medical devices.

[0002] Medical devices have multiple tubes for supplying liquids or gases. It is not easy to arrange multiple tubes inside medical devices that are being miniaturized for minimally invasive procedures. When tubes are bent smaller than their minimum bending radius to fit into a narrow space, they can buckle, potentially making it impossible to ensure the desired flow path cross-sectional area.

[0003] FIG. 10 of Japanese Patent Application Laid-Open No. 7-255664 discloses an endoscope that uses a bent pipe (paragraph 0088 of the above-mentioned specification) to change the flow direction of a tube disposed in an insertion portion.

[0004] However, the pipeline described in the above publication requires a bent pipe, which is a separate component from the tube, and also requires the work of connecting tubes to both ends of the bent pipe, resulting in a complex structure and the risk of unstable quality.

[0005] Japanese Patent Application Publication No. 7-255664

[0006] Embodiments of the present invention aim to provide a method for manufacturing a composite tube for medical devices having a curved region with a small bending radius, a composite tube for medical devices having a curved region with a small bending radius, and an endoscope including a composite tube for medical devices having a curved region with a small bending radius.

[0007] In one embodiment, a method for manufacturing a composite tube for a medical device involves forming at least one incision in a first tube made of a first resin, covering the area of ​​the first tube where the incision is formed with a second tube made of a second resin, thereby producing a work-in-progress tube, and then heat-shrinking the second tube, which is a heat-shrinkable tube.

[0008] The composite tube for medical devices of one embodiment comprises a first tube made of a first resin, having a curved region, and having at least one notch formed in the curved region, and a second tube made of a second resin, covering the curved region of the first tube.

[0009] The endoscope of one embodiment includes a composite tube for medical devices, the composite tube for medical devices including: a first tube made of a first resin, having a curved region, and having at least one notch formed in the curved region; and a second tube made of a second resin, covering the curved region of the first tube.

[0010] According to embodiments of the present invention, a method for manufacturing a composite tube for medical devices having a curved region with a small bending radius, a composite tube for medical devices having a curved region with a small bending radius, and an endoscope including a composite tube for medical devices having a curved region with a small bending radius can be provided.

[0011] FIG. 1 is a perspective view of an endoscope according to an embodiment. FIG. 2 is a partial cross-sectional view of a composite tube for medical devices according to a first embodiment. FIG. 3 is a flowchart of a method for manufacturing a composite tube for medical devices according to the first embodiment. FIG. 4A is a partial cross-sectional view for illustrating a method for manufacturing a composite tube for medical devices according to the first embodiment. FIG. 4B is a partial cross-sectional view for illustrating a method for manufacturing a composite tube for medical devices according to the first embodiment. FIG. 4C is a partial cross-sectional view for illustrating a method for manufacturing a composite tube for medical devices according to the first embodiment. FIG. 4D is a partial cross-sectional view for illustrating a method for manufacturing a composite tube for medical devices according to the first embodiment. FIG. 5 is a partial cross-sectional view of a composite tube for medical devices according to a modified example of the first embodiment. FIG. 6A is a partial cross-sectional view for illustrating a method for manufacturing a composite tube for medical devices according to a second embodiment. FIG. 6B is a partial cross-sectional view of a composite tube for medical devices according to the second embodiment. FIG. 7 is a partial cross-sectional view for illustrating a method for manufacturing a composite tube for medical devices according to a third embodiment. FIG. 8A is a partial cross-sectional view for illustrating a method for manufacturing a composite tube for medical devices according to a fourth embodiment. FIG. 8B is a partial cross-sectional view of a composite tube for medical devices according to the fourth embodiment. 9A and 9B are partial cross-sectional views for explaining a method for manufacturing a composite tube for a medical device according to a fifth embodiment.

[0012] First Embodiment Endoscope FIG. 1 is a perspective view of an endoscope 9 according to this embodiment.

[0013] The drawings based on the embodiments are schematic. The relationship between the thickness and width of each part in the drawings, the thickness ratio of each part, etc., differ from the actual ones. The drawings also include parts with different dimensional relationships and ratios. Some components are not shown and some symbols are omitted.

[0014] The endoscope 9 comprises a rigid tip portion 9A, a long and thin flexible portion 9B, an operating portion 9C disposed on the proximal end side of the flexible portion 9B, and a universal cord 9D extending from the operating portion 9C. An air / water supply tube, which is a composite tube for medical equipment 2 (hereinafter referred to as the "composite tube 2"), is inserted from the tip portion 9A to the universal cord 9D.

[0015] As will be described later, the composite tube 2 has a curved region with a small bending radius, so that the composite tube 2 can be positioned at a desired position at the small-diameter distal end portion 9A without using a bent pipe. This makes the endoscope 9 easy to manufacture.

[0016] The medical device in which the composite tube 2 is used is not limited to the endoscope 9, but may be, for example, a catheter or a treatment tool.

[0017] <Composite Tube> As shown in FIG. 2 , the composite tube 2 of this embodiment includes a first tube 10 and a second tube 20 that covers the first tube 10 .

[0018] The first tube 10 is made of a first resin such as a fluororesin. A slit C10 is formed in the first tube 10. The second tube 20 is made of a second resin such as a fluororesin. The second tube 20 is a heat-shrinkable tube after heat treatment, with an inner diameter smaller than the outer diameter of the first tube 10. The first resin and the second resin may be the same type of resin or different types of resin.

[0019] The composite tube 2 is curved such that the slits C10 of the first tube 10 are widened. The bending radius R2 of the composite tube 2 is smaller than the minimum bending radius of the first tube 10. However, because the slits C10 of the first tube 10 are positioned on the outside of the bend and are deformed to be widened, the first tube 10 does not buckle and the desired cross-sectional area of ​​the flow path is ensured. Furthermore, because the curved region of the first tube 10 where the slits C10 are formed is covered by the second tube 20, the airtightness of the flow path is ensured.

[0020] The bending radius R2 of the composite tube 2 is smaller than the minimum bending radius of the first tube 10. The minimum bending radius is the radius at which the outer diameter of the first tube 10 without any cuts is 90% of the outer diameter when it is circular, i.e., the radius when it is bent to the maximum. Therefore, the composite tube 2 does not require a separate member such as a bent pipe, and has a simple structure and stable quality.

[0021] <Manufacturing Method> A manufacturing method for the composite tube 2 will be described with reference to the flowchart of FIG.

[0022] <Step S10> Forming Cuts As shown in Figure 4A, cuts C10 are formed at predetermined positions on the first tube 10. The cuts C10 are formed perpendicularly from the outer peripheral surface toward the central axis O and extend beyond the central axis O. The depth of the cuts C10 is preferably more than 50% and less than 75% of the outer diameter of the first tube 10. If the depth of the cuts C10 is greater than this range, the first tube 10 can be easily bent to the desired bending radius, and if it is less than this range, there is no risk of breakage.

[0023] The notch C10 may be formed using a tool such as a knife or a cutter, or may be formed by laser processing.

[0024] <Step S20> Second Tube Arrangement As shown in FIG. 4B , a work-in-process (WIP) tube 2W is produced by arranging the second tube 20 so as to cover the area of ​​the first tube 10 where the cut C10 is formed. The inner diameter of the second tube 20, which is a heat-shrinkable tube, before shrinkage is greater than the outer diameter of the first tube 10. To ensure airtightness of the pipeline, it is preferable that the length of the second tube 20 be, for example, more than three times the outer diameter of the first tube 10.

[0025] In order to prevent further shrinkage of the second tube 20 after completion, it is preferable that the shrinkage temperature of the second tube 20 be higher than the maximum temperature in the cleaning and drying process of the endoscope 9 including the composite tube 2. In order to prevent excessive deformation of the first tube 10, it is preferable that the inner diameter of the second tube 20 when completely shrunk is more than 90% of the outer diameter of the first tube 10.

[0026] <Step S30> Bending As shown in Fig. 4C, the WIP tube 2W before heating, which includes the first tube 10 and the unshrunk second tube 20, is bent so that the slits C10 are on the outside. In order to bend the WIP tube 2W to a predetermined angle, it is preferable that the WIP tube 2W be fixed to a jig having a plurality of pins 40.

[0027] <Step S40> First Heating The second tube 20 is heated using a heat gun or the like, so that the inner periphery of the second tube 20 is brought into close contact with the outer periphery of the first tube 10. The heating temperature is set based on the specifications of the second tube 20, but is preferably lower than the softening temperature of the first tube 10.

[0028] When heating the second tube 20, it is preferable to heat the entire circumference uniformly at the same time, but in reality, this is not easy to achieve. Heat shrinkage of the second tube 20 may cause uneven stress to be applied to the first tube 10 or may change the curvature of the WIP tube 2W.

[0029] Therefore, when heating the second tube 20, it is preferable to heat the inner curved portion of the curved region first and then heat the outer curved portion.

[0030] The first heating is performed by heating the inside of the curve of the curved region.

[0031] <Step S50> Second Heating After the first heating, a second heating is performed to heat the outer side of the curve, completing the composite tube 2. The first and second heating temperatures may be the same, or, for example, the second heating temperature may be higher than the first heating temperature. Furthermore, after the second heating, a third heating at a temperature higher than the first and second heating temperatures may be performed on the entire circumference of the second tube 20.

[0032] <Modifications of the First Embodiment> Modifications of the first embodiment and other embodiments such as composite tubes 2A-2E described below are similar to and have the same effects as the composite tube 2 of the first embodiment. For this reason, components with the same functions as those of the composite tube 2 of the first embodiment are denoted by the same reference numerals, and descriptions thereof will be omitted.

[0033] As shown in FIG. 5, the second tube 20A of the composite tube 2A of this modified example is a so-called heat-shrinkable tube with adhesive, which has a hot-melt adhesive layer 22 on the inner peripheral surface of the tube body 21.

[0034] The hot melt adhesive layer 22 of the second tube 20A melts with heat during thermal shrinkage heating and deforms to conform to the irregularities on the outer peripheral surface of the first tube 10. Therefore, the composite tube 2A has higher airtightness than the composite tube 2.

[0035] Second Embodiment In a composite tube 2B of this embodiment, a plurality of cuts C10 are formed in a first tube 10B.

[0036] That is, as shown in Fig. 6A, three incisions C10 are formed in the first tube 10B. Therefore, as shown in Fig. 6B, in the composite tube 2B, the openings formed by the incisions C10 in the bent state are smaller than those of the composite tube 2. Furthermore, the composite tube 2B can be bent to a predetermined angle more easily during manufacturing than the composite tube 2.

[0037] The number of the incisions C10 is preferably equal to or less than 3. If the number exceeds this range, it is not easy to form the incisions C10, and there is a risk that the incisions C10 may cross each other.

[0038] Third Embodiment In a composite tube 2C of this embodiment, as shown in FIG. 7, a cut C10 inclined with respect to a central axis O is formed in a first tube 10C.

[0039] The opening of the inclined notch C10 becomes smaller when the second tube 20 contracts in a bent state. Therefore, the composite tube 2C has higher airtightness than the composite tube 2.

[0040] Fourth Embodiment In a composite tube 2D of this embodiment, a V-shaped notch V10 is formed in a first tube 10C as shown in Fig. 8A. The notch V10 is produced by forming two notches C10 so that they intersect.

[0041] 8B , the composite tube 2D has a smaller opening due to the notch V10 after bending, and therefore has higher airtightness than the composite tube 2. Furthermore, the composite tube 2D is easier to bend and deform during manufacturing than the composite tube 2. Note that the notch V10 is preferably located on the inner side of the bend, but may also be located on the outer side of the bend.

[0042] 9A and 9B , a first tube 10E of a composite tube 2E has not only a V-shaped notch V10 but also a notch C10 formed in a region opposite the region where the notch V10 is formed across the central axis O. The V-shaped notch V10 is formed by two notches C10.

[0043] The composite tube 2E can be bent and deformed more easily than the composite tube 2 during manufacturing.

[0044] It goes without saying that the composite tubes 2B-2E may have a second tube having a hot melt adhesive layer 22, similar to the composite tube 2A.

[0045] Furthermore, it goes without saying that the endoscopes having the composite tubes 2A-2E of the modified examples of the first embodiment and the second to fifth embodiments have the same effects as the endoscope 9 having the composite tube 2 of the first embodiment, and further have the respective effects of the composite tubes 2A-2E.

[0046] Although the composite tube has been described as being disposed at the distal end 9A, it may be disposed at any desired location of the air / water supply pipe, such as the operating section 9C. It may also be used for a tubular member such as a treatment tool channel (not shown) through which a treatment tool is inserted.

[0047] The ranges of the numerical values ​​described above are not limited to the ranges described above and can be increased or decreased as appropriate. Furthermore, the present invention is not limited to the above-described embodiments, and various changes and modifications can be made within the scope of the present invention.

[0048] This application claims priority from Japanese Patent Application No. 2024-099832 filed in Japan on June 20, 2024, and the above contents are incorporated herein by reference in the specification, claims, and drawings.

[0049] 2, 2A-2E... Composite tube for medical device 2W... WIP tube 9, 9A-9E... Endoscope 10... First tube 21... Tube body 22... Hot melt adhesive layer 40... Pin

Claims

1. A method for manufacturing composite tubing for medical devices, comprising: forming at least one slit in a first tube made of a first resin; covering the area of ​​the first tube where the slit is formed with a second tube made of a second resin to produce a work-in-progress tubing; and heat-shrinking the second tube, which is a heat-shrinkable tubing.

2. The method for manufacturing a composite tube for medical devices described in claim 1, characterized in that before heating the second tube, the area of ​​the WIP tube where the slits are formed is bent to a predetermined bending radius, and the second tube is heated while the WIP tube is in a bent state.

3. A method for manufacturing a composite tube for medical devices as described in claim 1, characterized in that when heating the second tube, the inside of the curved region is heated first, and then the outside of the curved region is heated.

4. A method for manufacturing a composite tube for medical devices as described in claim 2, characterized in that the second tube has a hot melt adhesive layer on its inner surface that melts when the second tube is heated.

5. A method for manufacturing a composite tube for medical devices according to claim 1, characterized in that the cut is formed perpendicular to the central axis of the first tube.

6. The method for manufacturing a composite tube for medical devices according to claim 1, characterized in that a plurality of cuts are formed in the first tube.

7. The method for manufacturing a composite tube for medical devices according to claim 1, wherein the cut is formed at an angle relative to the central axis of the first tube.

8. A method for manufacturing a composite tube for medical devices according to claim 1, characterized in that two of the cuts are formed in the first tube to form a V-shaped notch.

9. A method for manufacturing a composite tube for medical devices as described in claim 1, characterized in that a V-shaped notch is formed in the first tube, and a further notch is formed in the area opposite the area where the notch is formed across the central axis.

10. A method for manufacturing a composite tube for medical devices according to claim 2, characterized in that the predetermined bending radius is smaller than the minimum bending radius of the first tube.

11. A composite tube for medical devices, comprising: a first tube made of a first resin, having a curved region with at least one notch formed in the curved region; and a second tube made of a second resin, covering the curved region of the first tube.

12. The composite tube for medical devices according to claim 11, wherein the bending radius of the curved region is smaller than the minimum bending radius of the first tube.

13. The composite tube for medical devices according to claim 11, wherein the second tube is heat-shrunk by heat treatment.

14. The composite tube for medical devices according to claim 11, wherein the cut is perpendicular to the central axis of the first tube.

15. The composite tube for medical devices according to claim 11, wherein the second tube has a hot melt adhesive layer on the inner surface.

16. The composite tube for medical devices according to claim 11, wherein the first tube has a plurality of cuts formed in the curved region.

17. The composite tube for medical devices according to claim 11, wherein the cut is inclined with respect to the central axis of the first tube.

18. The composite tube for medical devices according to claim 11, wherein the first tube has two notches forming a V-shaped notch.

19. A composite tube for medical devices according to claim 18, characterized in that it has the V-shaped notch and a plurality of notches in an area opposite the V-shaped notch across the central axis.

20. An endoscope comprising a composite tube for medical devices, the composite tube for medical devices comprising: a first tube made of a first resin, having a curved region with at least one notch formed in the curved region; and a second tube made of a second resin, covering the curved region of the first tube.

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