Insertion tube for endoscope and manufacturing method thereof

Abstract

The embodiment of the invention provides an insertion tube for an endoscope and a manufacturing method of the insertion tube, and relates to the field of medical instruments. The insertion tube for the endoscope comprises a spring tube, an inner polymer layer, a woven mesh layer, an outer polymer layer and at least one outer surface layer which are sequentially sleeved from inside to outside, the outer surface layer is made of a corrosion-resistant, bending-cracking-resistant and wear-resistant material, and the outer wall of the outer surface layer is smooth. According to the spring tube, the insertion tube has good bending resistance and column strength, the inner polymer layer and the outer polymer layer have good elasticity and toughness, the woven mesh layer can transmit torque and thrust, the outer surface layer is wear-resistant, smooth and flat, friction between the insertion tube and a cavity in the insertion process can be reduced, discomfort and scratch risks are reduced, and the service life of the insertion tube is prolonged. Compared with an existing insertion tube, the whole insertion tube is more excellent in performance and is more suitable for operation. The embodiment of the invention further provides a manufacturing method for manufacturing the insertion tube for the endoscope.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more specifically, to an endoscopic insertion tube and its manufacturing method. Background Technology

[0002] The insertion cannula of a flexible endoscope is the long, thin, and flexible section at the tip of the endoscope. It is used to enter natural body cavities (such as the digestive, respiratory, or urinary tracts) or surgical openings for observation and surgical procedures. The insertion cannula is typically composed of multiple layers, including a polymer layer, a stainless steel braided layer, and a soft rubber layer, to provide bending and torsional rigidity, ensuring that the surgeon can precisely control its direction of advancement.

[0003] However, in the existing multi-layer composite processing of endoscopic insertion tubes, different layers of tubes are generally manufactured separately, and then the different tubes are assembled and bonded together in sequence. Therefore, the processing efficiency is relatively low. Moreover, the outer surface of the processed insertion tube is not smooth enough, and the outer diameter is not consistent. During clinical use, the insertion tube will have greater friction with the human body cavity, which can easily cause scratches to patients, causing discomfort or even secondary infection. Summary of the Invention

[0004] This invention provides an endoscope insertion tube and its manufacturing method, which can solve the above-mentioned problems.

[0005] The embodiments of the present invention can be implemented as follows: An embodiment of the present invention provides an insertion tube for an endoscope, comprising: a spring tube, an inner polymer layer, a braided mesh layer, an outer polymer layer and an outer surface layer sequentially connected from the inside to the outside, wherein the outer surface layer is at least one layer and is made of a material that is corrosion-resistant, resistant to bending and cracking and wear-resistant, and has a smooth outer wall.

[0006] Optionally, hydrophilic materials may be added to the material used to make the outer layer.

[0007] Optionally, the number of layers of the spring tube is at least one.

[0008] Optionally, the spring tube has two layers, including an inner tube and an outer tube. The inner tube extends in a right-handed manner, and the outer tube extends in a left-handed manner. The inner tube is located inside the outer tube and is bonded to the outer tube.

[0009] Optionally, the spiral width of the inner tube gradually increases from the first end to the second end, and the pitch of the inner tube gradually decreases from the first end to the second end; wherein, the first end refers to the end away from the handle operating end, and the second end refers to the end closer to the handle operating end; And / or, the helix width of the outer tube gradually increases from the first end to the second end, and the pitch of the outer tube gradually decreases from the first end to the second end.

[0010] Optionally, the stress / modulus of the adhesive used to bond the inner tube and the outer tube is set to gradually increase in multiple gradients from the first end to the second end.

[0011] Optionally, the spring tube is a helical spring tube, which unfolds along its helix to form a thin sheet of metal.

[0012] Optionally, the surface of the outer polymer layer is provided with graduations, which are laser-processed onto the outer polymer layer; the outer surface layer is a transparent layer.

[0013] Embodiments of the present invention also provide a manufacturing method for manufacturing the above-mentioned endoscopic insertion tube, comprising: The inner polymer layer is continuously extruded onto the inner liner using an extruder; A braided mesh layer is formed by continuously weaving the outer layer of the inner polymer layer using a braiding machine; An outer polymer layer is continuously extruded from the outside of the woven mesh layer using an extruder, and the inner polymer layer and the outer polymer layer are thermally melted together. Cooling and shaping; Use a laser marking machine to process the scale on the surface of the outer polymer layer; An outer surface layer is continuously extruded from the outside of the outer polymer layer using an extruder, and the outer surface layer encapsulates the outer polymer layer inside. Cooling and shaping; Spring tubes are manufactured using spring tube forming equipment, and the outer diameter of the formed spring tube is larger than the outer diameter of the inner liner tube. The spring tube is inserted into the tooling to rotate, shrink and lock the pre-shaped spring tube, and then adhesive is applied to the outside of the spring tube. Remove the inner liner tube, insert the pre-shaped locking spring tube into the interior of the inner polymer layer, release the pre-shaped spring tube, and the spring tube expands and adheres to the inner wall of the inner polymer layer to form the finished insertion tube.

[0014] Beneficial effects of the embodiments of the present invention: This endoscopic insertion tube comprises, from the inside out, a spring tube, an inner polymer layer, a braided mesh layer, an outer polymer layer, and an outer surface layer, all sequentially connected. The outer surface layer is at least one layer, made of a corrosion-resistant, bend-resistant, crack-resistant, and wear-resistant material with a smooth outer wall. The spring tube in this embodiment provides the insertion tube with excellent bend resistance and column strength; the inner and outer polymer layers possess good elasticity and toughness; the braided mesh layer can transmit torque and thrust; and the outer surface layer is wear-resistant, smooth, and has good consistency in outer diameter, reducing friction between the insertion tube and the cavity during insertion, thus lowering discomfort and the risk of scratches. The entire insertion tube exhibits superior performance compared to existing insertion tubes and is more suitable for surgical use.

[0015] This manufacturing method is used to manufacture the aforementioned endoscopic insertion tube. Attached Figure Description

[0016] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0017] Figure 1 This is a schematic diagram of the structure of the endoscope insertion tube provided in an embodiment of the present invention; Figure 2 This is a schematic diagram of the structure of the spring tube provided in an embodiment of the present invention when the spring tube has two layers and opposite directions of rotation; Figure 3 This is a schematic cross-sectional view of the spring tube along the axial direction provided in an embodiment of the present invention; Figure 4 This is a schematic diagram of an extruded pipe manufacturing production line provided in an embodiment of the present invention; Figure 5 This is a schematic diagram of a woven mesh layer woven into an inner polymer layer, as provided in an embodiment of the present invention; Figure 6 This is a schematic diagram of an outer polymer layer wrapped around a woven mesh layer (when the outer polymer layer has not cooled and shrunk) provided in an embodiment of the present invention; Figure 7 This is a schematic diagram of an outer polymer layer wrapped around a woven mesh layer (after the outer polymer layer has cooled and shrunk) in an embodiment of the present invention. Figure 8 This is a schematic diagram of an outer layer wrapped around an outer polymer layer (after the outer layer cools and shrinks) in an embodiment of the present invention.

[0018] Icons: 10-Spring tube; 101-Inner tube; 102-Outer tube; 20-Inner polymer layer; 30-Woven mesh layer; 40-Outer polymer layer; 401-Scale; 50-Outer layer; 60-Extruder; 61-Laser marking machine; 62-Blower; 63-Controller. Detailed Implementation

[0019] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0020] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0021] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0022] In the description of this invention, it should be noted that if terms such as "upper," "lower," "inner," or "outer" are used to indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this invention is usually placed, they are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0023] Furthermore, the terms "first" and "second" are used only to distinguish descriptions and should not be interpreted as indicating or implying relative importance.

[0024] The terms “comprising,” “including,” or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitation, an element defined by the phrase “comprising one…” does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0025] Unless otherwise explicitly specified and limited, terms such as "setup" and "connection" should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0026] It should be noted that, for the sake of simplicity, the aforementioned method embodiments are all described as a series of actions. However, those skilled in the art should understand that this application is not limited to the described order of actions, because according to this application, some steps can be performed in other orders or simultaneously. The steps in the methods of this application embodiments can be adjusted, combined, or deleted according to actual needs.

[0027] It should be noted that, where there is no conflict, the features in the embodiments of the present invention can be combined with each other.

[0028] The insertion tube of a flexible endoscope is the long, thin, and flexible section at the tip of the endoscope, responsible for entering natural body cavities (such as the digestive, respiratory, or urinary tracts) or surgical openings for observation and surgical procedures. The insertion tube is typically composed of multiple layers, including a polymer layer, a stainless steel braided layer, and a soft rubber layer, to provide bending and torsional stiffness, ensuring precise control of the surgeon's direction of advance. However, current multi-layered composite manufacturing processes for endoscopic insertion tubes generally involve manufacturing different layers of tubing separately, then sequentially fitting and bonding them together. This results in relatively low processing efficiency. Furthermore, the outer surface of the processed insertion tube is not smooth enough, and the consistency of its outer diameter is inconsistent. During clinical use, the insertion tube experiences significant friction with body cavities, easily causing scratches, discomfort, and even secondary infections. Additionally, the unevenness of the insertion tube can cause stress concentration, affecting the overall column strength and lifespan.

[0029] Existing insert tube manufacturing processes typically require multiple different pieces of equipment, resulting in complex procedures, low production efficiency, and high costs. For example, a current insert tube manufacturing process involves first processing various layers of tubing using different equipment (using spring processing equipment to process spring tubes, using a braiding machine to process braided mesh tubing, using an extruder to process the polymer outer skin, and using an extruder and expansion molding equipment to process heat shrink tubing). Then, the multi-layered tubing is gradually assembled, bonded, and printed. Specifically, in a 1:1 ratio, spring tubes, braided mesh tubing, and polymer outer skin are sequentially fitted onto a support mandrel. Before the spring tubes are fitted with the braided mesh tubing, and before the braided mesh tubing is fitted with the polymer outer skin, it is necessary to... Adhesive is applied to the outer periphery of the tube; the heat shrink tubing is then fitted onto the outer periphery of the polymer outer skin, and a non-continuous composite heat shrink molding process is performed using a laminating machine. After molding, the outer skin of the heat shrink tubing is removed (the function of the heat shrink tubing is mainly for shaping the tube body, not as part of the tube material, so it must be removed). The outer polymer layer is pretreated by cleaning and activation using processes such as plasma, corona, and flame treatment. Scale printing is then performed on the outer polymer layer of the multi-layer tube using a printing machine, followed by ink curing. Finally, the top coating layer is processed using spraying, brushing, or dip coating processes, and then cured and laminated.

[0030] It is evident that the existing methods for manufacturing insertion tubes are not only complex and involve many steps, but also require the use of various different equipment, resulting in high costs and low production efficiency.

[0031] In view of the above problems, embodiments of the present invention provide an endoscope insertion tube and a method for manufacturing the same, which can solve the above problems, and will be described in detail below.

[0032] Please refer to Figure 1 The endoscope insertion tube includes a spring tube 10, an inner polymer layer 20, a braided mesh layer 30, an outer polymer layer 40 and an outer surface layer 50, which are sequentially connected from the inside to the outside. The outer surface layer 50 has at least one layer and is made of a material that is corrosion-resistant, resistant to bending and cracking and wear-resistant, and has a smooth outer wall.

[0033] The spring tube 10 of this invention provides the insertion tube with good bending resistance and column strength. The inner polymer layer 20 and the outer polymer layer 40 have good elasticity and toughness. The braided mesh layer 30 can transmit torque and thrust. The outer surface layer 50 is wear-resistant and smooth, which can reduce friction between the insertion tube and the cavity during insertion, reduce patient discomfort and the risk of scratches during insertion. The smooth and full surface of the insertion tube can also achieve better column strength, torque transmission and pushing performance, and ensure service life. Compared with existing insertion tubes, it has better performance and is more suitable for surgical use.

[0034] In this embodiment, the outer layer 50 needs to be made of a transparent polymer material with strong resistance to chemical corrosion, wear, sterilization, bending, and tearing, and capable of bonding with the outer polymer layer 40. This could include, but is not limited to, modified materials such as polyurethane, acrylic resins, epoxy resins, and fluoropolymers. Furthermore, functional components can be added to the material used to make the outer layer 50 to obtain a corresponding functional surface layer.

[0035] To make the outer layer 50 slide more smoothly into the human body cavity, hydrophilic materials, such as hydrophilic polymers, can be added to the material of the outer layer 50. This allows the outer layer 50 to become smoother when wetted with water, reducing the difficulty of inserting the insertion tube and avoiding scratches and discomfort to the patient's cavity. To further improve the flatness and smoothness of the outer surface of the insertion tube, the outer layer 50 can be multi-layered, with multiple layers filling in uneven areas.

[0036] refer to Figure 1The outer polymer layer 40 has graduations 401 on its surface. These graduations provide medical personnel with a reference point during tube insertion to monitor the insertion depth in real time. The graduations 401 are laser-processed onto the outer polymer layer 40, replacing printed graduations. This method ensures the graduations are less prone to peeling off and leaves no ink residue, making it environmentally friendly and safe. The outer layer 50 is transparent, covering the graduations 401 without obstructing their view. It also reduces surface roughness caused by the graduations and eliminates the risk of burrs or fibers from laser ablation.

[0037] The outer polymer layer 40 and the inner polymer layer 20 need to have flexibility and elasticity to accommodate deformation and recovery during insertion of the insertion tube. The outer polymer layer 40 and the inner polymer layer 20 can be made of materials such as polyurethane, polyether block polyamide, or polyethylene. Functional components such as colorants can also be added to the outer polymer layer 40 to obtain the desired color / functional surface layer.

[0038] A braided mesh layer 30 is provided between the outer polymer layer 40 and the inner polymer layer 20. The braided mesh layer 30 is used to provide torque transmission and pushing capability for the insertion tube. The braided mesh layer 30 can generally be woven from metal or polymer braided filament materials. The formed braided mesh layer 30 can be a single layer or multiple layers. When the braided mesh layer 30 is a single layer, the material / density / shape of different sections of the braided mesh layer 30 can be the same or different. When the braided mesh layer 30 has multiple layers, the material / density / shape of the multiple braided mesh layers can be the same or different. The specific combination and arrangement can be designed and arranged according to the requirements.

[0039] A spring tube 10 is disposed inside the inner polymer layer 20, which provides good support strength (column strength) and ensures bending resistance. The spring tube 10 can be made of metal materials such as stainless steel, so that the formed spring tube 10 has good bending resistance and column strength.

[0040] The number of layers in the spring tube 10 can be one, two, or more.

[0041] refer to Figure 2In this embodiment, the spring tube 10 has two layers, including an inner tube 101 and an outer tube 102. The inner tube 101 extends clockwise, and the outer tube 102 extends counterclockwise. The inner tube 101 is located inside the outer tube 102 and is bonded to it. The two-layer configuration with opposite directions of rotation of the spring tube 10 further improves the resistance to kinking and torsional deformation of the tube body. In this embodiment, the inner tube 101 and the outer tube 102 have opposite directions of rotation and are constrained by the braided mesh layer 30 to form a more stable skeleton. This not only provides support strength (column strength) and bending resistance, but also provides resistance to kinking and torsional deformation, and achieves more precise torque transmission capability, stronger resistance to collapse, and stronger resistance to bending fatigue. It produces performance effects far superior to single-layer springs or double-layer springs with the same direction of rotation. The combination with the woven mesh layer 30 further achieves a more perfect balance in terms of anti-kink properties, torque transmission, pushing force, tensile strength, and flexibility, thereby ensuring that the endoscope can complete examination or treatment tasks more safely, comfortably, and accurately.

[0042] refer to Figure 3 The helix width W1 of the inner tube 101 gradually increases from the first end to the second end, and the pitch W2 of the inner tube 101 gradually decreases from the first end to the second end; the helix width W1 of the outer tube 102 gradually increases from the first end to the second end, and the pitch W2 of the outer tube 102 gradually decreases from the first end to the second end. Here, the first end refers to the end furthest from the handle operating end, and the second end refers to the end closest to the handle operating end. The first end is the end that enters the human body cavity, and the second end is the end outside the human body. The advantage of this design is that it allows for modification of the bending and other properties of the first and second ends of the spring tube 10.

[0043] Setting a smaller helix width and a larger pitch at the first end of the inner tube 101 and outer tube 102 improves the bending performance and flexibility of the first end of the tube, allowing it to better adapt to human cavities, making insertion easier, improving patient comfort during insertion, and reducing the risk of tube damage. Setting a larger helix width and a smaller pitch at the second end of the inner tube 101 and outer tube 102 improves the rigidity and pushing ability of the second end of the tube, resulting in better maneuverability. Furthermore, a gradually changing helix width, rather than abrupt segmentation, avoids stress concentration in the transition area where the helix width changes sharply, thus improving service life.

[0044] The spring tube 10 is a helical spring tube. After the spring tube 10 is rotated and unfolded along its axis, a thin sheet-like metal strip is formed by the helix.

[0045] The outer tube 102 of the spring tube 10 is bonded to the inner wall of the inner polymer layer 20 with adhesive, and the outer tube 102 of the spring tube 10 is also bonded to the inner tube 101 with adhesive. The stress / modulus of the adhesive used to bond the inner tube 101 and the outer tube 102 is set to gradually increase from the first end to the second end in multiple gradients. The first end refers to the end away from the handle operating end, and the second end refers to the end closer to the handle operating end. This setting is determined according to the stress / tensile modulus of different parts of the spring tube 10. The first end of the spring tube 10 has low stress and low tensile modulus, so low stress or low modulus adhesive can be used. The second end has high stress and high tensile modulus, so high stress or high modulus adhesive is required. Similarly, the adhesive between the inner polymer layer 20 and the outer tube 102 is also determined according to the stress / tensile modulus. The first end has low stress and low tensile modulus, so a low-stress or low-modulus adhesive is used. The second end has high stress and high tensile modulus, so a high-stress or high-modulus adhesive is required. The stress / modulus of the adhesive mentioned here can be understood as the hardness of the adhesive after curing. Since the first end needs to be flexible, an adhesive with lower hardness after curing is required. The second end needs to have a certain supporting strength, so an adhesive with higher hardness after curing is required.

[0046] The adhesives used for bonding can be epoxy resin, silicone rubber, or other similar adhesives, which can provide interlayer bonding and composite functions.

[0047] To manufacture the insertion tube more efficiently and reduce the complexity of the manufacturing process, embodiments of the present invention also provide a manufacturing method for manufacturing the above-mentioned endoscopic insertion tube, comprising the following steps: S1: Use an extruder 60 to continuously extrude polymer material onto the inner liner tube to form an inner polymer layer 20; the inner liner tube material can be selected from polyoxymethylene (POM), polybutylene terephthalate (PBT), fluorinated resin, etc., which have good anti-adhesion, low coefficient of friction, easy peeling and certain support strength, thus avoiding the adhesion between the inner polymer layer 20 and the inner liner tube and reducing the difficulty of peeling the inner polymer layer 20 from the inner liner tube.

[0048] S2: Using a braiding machine, continuously braid threads on the outside of the inner polymer layer 20 to form a braided mesh layer 30.

[0049] S3: Using an extruder 60, polymer material is continuously extruded on the outside of the woven mesh layer 30 to form an outer polymer layer 40. The outer polymer layer 40 covers the outside of the woven mesh layer 30 and the inner polymer layer 20. The inner polymer layer 20 and the outer polymer layer 40 are fixed by high-temperature hot melt composite bonding.

[0050] S4: Cooling and shaping.

[0051] S5: Use laser marking machine 61 to process the scale 401 on the surface of the outer polymer layer 40.

[0052] S6: Using an extruder 60, an outer surface layer 50 is continuously extruded over the outer polymer layer 40, the outer surface layer 50 enclosing the scale 401 and the outer polymer layer 40 inside.

[0053] S7: Cooling and shaping.

[0054] S8: A spring tube 10 is manufactured using a spring tube forming equipment. The outer diameter of the formed spring tube 10 is larger than the outer diameter of the inner liner tube. For example, the outer diameter of the spring tube 10 is 0.1~0.5mm larger than the outer diameter of the inner liner tube. The spring tube forming equipment is existing equipment.

[0055] S9: Use a spring tube insertion fixture to rotate, shrink, and lock the pre-shaped spring tube 10, and then apply adhesive to the outside of the spring tube 10; the adhesive can be applied to the outside of the spring tube 10 by brushing or by immersing the spring tube 10 in a container or tank containing adhesive, and there is no specific limitation; the spring tube insertion fixture can be any fixture device in the prior art.

[0056] S10: Remove the inner liner tube, insert the pre-shaped locking spring tube 10 into the interior of the inner polymer layer 20, release the pre-shaped spring tube 10, and the spring tube 10 expands to adhere to the inner wall of the inner polymer layer 20. The adhesive on the spring tube 10 bonds and fixes the spring tube 10 to the inner polymer layer 20 together, forming the finished insertion tube. The spring tube insertion tooling generally includes a mandrel. The spring tube 10 is tightened and wound around the mandrel. The mandrel carries the tightened spring tube 10 into the tube body of the inner polymer layer 20. Since the outer diameter of the spring tube 10 is larger than the outer diameter of the inner liner tube, that is, the outer diameter of the spring tube 10 is larger than the inner diameter of the inner polymer layer 20, when the pre-shaped locking spring tube 10 is released, it will expand, thereby pressing against the inner polymer layer 20. Remove the mandrel and perform thermosetting to form the finished insertion tube.

[0057] The adhesive used on the spring tube 10 is a medium-to-low viscosity, low-stress adhesive, while the mandrel is made of a non-stick material such as polytetrafluoroethylene, which facilitates the separation of the mandrel from the spring tube 10.

[0058] If the outer diameter of the spring tube 10 is larger than the inner diameter of the inner polymer layer 20, then after the spring tube 10 is released, it will form an interference fit with the inner polymer layer 20. The connection between the spring tube 10 and the inner polymer layer 20 will be stronger and the overall integrity will be better, further ensuring that the spring tube 10 provides support strength (column strength) and bending resistance.

[0059] In this embodiment, the fabrication of the spring tube 10 and the extruded tube can be carried out simultaneously to shorten the fabrication time and improve production efficiency.

[0060] Before extruding the outer layer 50 in step S6, the outer polymer layer 40 needs to be completely cooled and set before the extrusion operation of the outer layer 50 can be carried out. In addition, both the outer polymer layer 40 and the outer layer 50 can be extruded in multiple layers. When the number of extruded layers is greater than one, the inner layer needs to be cooled and set before the extrusion operation can be carried out.

[0061] In this embodiment, at least one outer surface layer 50 is provided on the outer polymer layer 40, which can improve the smoothness and flatness of the surface of the inserted tube after molding, as well as the consistency of the outer diameter. This will be described in detail below.

[0062] Let the thickness of the woven mesh layer 30 be H1, that is, let the cutout height of the woven mesh layer 30 be H1, such as Figure 5 Before the outer polymer layer 40 cools and sets, the thickness of the outer polymer layer 40 covering the hollowed-out portion of the woven mesh layer 30 is H3, and the thickness covering the portion of the woven mesh layer 30 is H2, as shown below. Figure 6 After the outer polymer layer 40 cools and sets, due to the shrinkage rate P1 of the polymer layer, a surface with a height difference of H is formed on the surface of the outer polymer layer 40, such as... Figure 7 , H=(H3×P1)-(H2×P1)=(H3-H2)×P1=H1×P1.

[0063] If an outer layer 50 is further wrapped around the shaped outer polymer layer 40, and the shrinkage rate of the outer layer 50 is P2, then the height difference h of the uneven surface formed after the outer layer 50 cools and sets will further decrease, where h = H1 × P1 × P2. Figure 8 .

[0064] For example, when H1=0.15mm, P1=10%, and P2=10%, we can calculate that H=0.015mm and h=0.0015mm. Since h is much smaller than H, the smoothness of the outer surface of the inserted tube is greatly improved.

[0065] Similarly, when the outermost layer has multiple layers (50), the outer surface of the insertion tube becomes smoother and flatter, greatly reducing friction between the insertion tube and the cavity during insertion, thus reducing discomfort and the risk of scratches. A smooth and full outer surface also provides better column strength, torque transfer, and delivery performance, making it more suitable for surgical use.

[0066] refer to Figure 4 , Figure 4In this embodiment of the extruded pipe manufacturing production line, the inner polymer layer 20, the braided mesh layer 30, the outer polymer layer 40, the scale 401, and the outer surface layer 50 can be obtained through segmented continuous processing. Specifically, this includes: first, extruding and molding the inner polymer layer 20; then, braiding and processing the braided mesh layer 30; then, extruding the outer polymer layer 40; and finally, extruding the outer surface layer 50. During manufacturing, the inner polymer layer 20 can be quickly extruded using an extruder 60, and then transferred to multiple braiding machines for continuous processing of the braided mesh layer 30 to obtain a semi-finished product. The semi-finished product is then transferred to a further processing line. Figure 4 The extruded pipe manufacturing production line shown performs processing operations on the outer polymer layer 40 and the outer surface layer 50. In the extruded pipe manufacturing production line, a blower 62 is installed in the area where the pipe needs to be cooled and shaped to accelerate cooling. A laser marking machine 61 is installed behind the extruded outer polymer layer 40 to print scales 401. A controller 63 comprehensively controls the stopping and advancing of the pipe.

[0067] In other embodiments, a water chiller can be used instead of the blower 62 to cool the extruded tubing.

[0068] In this embodiment, except for the spring tube 10 which needs to be manufactured and installed separately, the inner polymer layer 20, the braided mesh layer 30, the outer polymer layer 40 and the outer surface layer 50 can all be obtained by segmented continuous processing. The types of equipment required for processing are fewer, and the processes are continuous and can be monitored and controlled in real time, which can greatly improve production efficiency, reduce costs and obtain a stable and high-performance insertion tube.

[0069] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. An inserter for an endoscope, characterized in that, include: The spring tube (10), inner polymer layer (20), woven mesh layer (30), outer polymer layer (40) and outer surface layer (50) are sequentially connected from the inside to the outside. The outer surface layer (50) is at least one layer and is made of a material that is corrosion-resistant, resistant to bending and cracking and wear-resistant, and has a smooth outer wall.

2. The endoscopic insertion tube according to claim 1, characterized in that, The outer layer (50) is made of a material containing hydrophilic materials.

3. The endoscopic insertion tube according to claim 1, characterized in that, The spring tube (10) has at least one layer.

4. The endoscopic insertion tube according to claim 3, characterized in that, The spring tube (10) has two layers, including an inner tube (101) and an outer tube (102). The inner tube (101) extends clockwise, and the outer tube (102) extends counterclockwise. The inner tube (101) is located inside the outer tube (102) and is bonded to the outer tube (102).

5. The endoscopic insertion tube according to claim 4, characterized in that, The spiral width of the inner tube (101) gradually increases from the first end to the second end, and the pitch of the inner tube (101) gradually decreases from the first end to the second end; wherein, the first end refers to the end away from the handle operating end, and the second end refers to the end close to the handle operating end; And / or, the helix width of the outer tube (102) gradually increases from the first end to the second end, and the pitch of the outer tube (102) gradually decreases from the first end to the second end.

6. The endoscopic insertion tube according to claim 4, characterized in that, The stress / modulus of the adhesive used to bond the inner tube (101) and the outer tube (102) is set to gradually increase in multiple gradients from the first end to the second end.

7. The endoscopic insertion tube according to any one of claims 1-6, characterized in that, The spring tube (10) is a spiral spring tube, which unfolds along its spiral line to form a thin sheet-like metal strip.

8. The endoscopic insertion tube according to claim 7, characterized in that, The outer polymer layer (40) has a scale (401) on its surface, and the scale (401) is laser-processed on the outer polymer layer (40); the outer surface layer (50) is a transparent layer.

9. A method for manufacturing an endoscope insertion tube as described in claim 7, characterized in that, include: The inner polymer layer (20) is continuously extruded onto the inner liner using an extruder (60). A braided mesh layer (30) is formed by continuously weaving the outer layer of the inner polymer layer (20) using a braiding machine. An outer polymer layer (40) is continuously extruded on the outside of the woven mesh layer (30) using an extruder (60), and the inner polymer layer (20) and the outer polymer layer (40) are thermally melt-bonded. Cooling and shaping; Using an extruder (60), an outer surface layer (50) is continuously extruded on the outside of the outer polymer layer (40), the outer surface layer (50) wrapping the outer polymer layer (40) inside; Cooling and shaping; The spring tube (10) is made using a spring tube forming equipment. The outer diameter of the formed spring tube (10) is larger than the outer diameter of the inner liner tube. The spring tube (10) is shaped by rotating and locking the spring tube (10) through the tooling and then adhesive is applied to the outside of the spring tube (10). Pull out the inner liner tube, insert the locking pre-shaped spring tube (10) into the interior of the inner polymer layer (20), release the pre-shaped spring tube (10), the spring tube (10) expands and adheres to the inner wall of the inner polymer layer (20) to form the finished insertion tube.

10. A method for manufacturing an endoscope insertion tube as described in claim 8, characterized in that, include: The inner polymer layer (20) is continuously extruded onto the inner liner using an extruder (60). A braided mesh layer (30) is formed by continuously weaving the outer layer of the inner polymer layer (20) using a braiding machine. An outer polymer layer (40) is continuously extruded on the outside of the woven mesh layer (30) using an extruder (60), and the inner polymer layer (20) and the outer polymer layer (40) are thermally melt-bonded. Cooling and shaping; The scale (401) is processed on the surface of the outer polymer layer (40) using a laser marking machine (61). Using an extruder (60), an outer surface layer (50) is continuously extruded on the outside of the outer polymer layer (40), the outer surface layer (50) wrapping the outer polymer layer (40) inside; Cooling and shaping; The spring tube (10) is made using a spring tube forming equipment. The outer diameter of the formed spring tube (10) is larger than the outer diameter of the inner liner tube. The spring tube (10) is shaped by rotating and locking the spring tube (10) through the tooling and then adhesive is applied to the outside of the spring tube (10). Pull out the inner liner tube, insert the locking pre-shaped spring tube (10) into the interior of the inner polymer layer (20), release the pre-shaped spring tube (10), the spring tube (10) expands and adheres to the inner wall of the inner polymer layer (20) to form the finished insertion tube.

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