Bending-adjustable conduit and preparation process thereof

Abstract

The invention relates to an adjustable bending guide pipe and a preparation process thereof. The process comprises the following steps: carrying out rough treatment on the surface of a snake bone pipe; the snake bone pipe is arranged on an inner layer material in a sleeving mode; an outer layer material is arranged on the outer surface of the snake bone pipe in a sleeving mode; and heating, shaping and cooling to obtain the adjustable bending guide pipe. According to the scheme that a braided tube is replaced by the snake-bone tube, the supporting performance can be enhanced, the later-stage manufacturing procedure can be simplified, the surface roughness of the snake-bone tube is increased through roughening treatment on the snake-bone tube, and therefore the snake-bone tube can be tightly combined with an inner layer material and an outer layer material, and the sealing performance and controllability of the bend adjusting tube are guaranteed.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an adjustable bendable catheter and its manufacturing process. Background Technology

[0002] Currently, adjustable catheters mainly include fully braided tubing, fully serpentine tubing, or a combination of braided and serpentine tubing. They are primarily composed of an inner PTFE layer, a middle braided filament layer, and an outer thermoplastic polymer material. Typically, braided tubing uses a mesh-like braided structure, while serpentine tubing is made of stainless steel. The adjustable catheter structure is divided into a support section and a bending section. The support section needs sufficient support to keep the tube straight and without bulging, reducing bending resistance and risks during surgery. Due to the limitations of the mesh structure in the braided section, the support of the braided tubing is relatively weak and unsuitable as a support section. Using a serpentine tube in the support section can greatly improve the support rigidity. However, the gaps in the serpentine tube in the support section are not as dense as the mesh of the braided tube. This results in less contact area between the outer material and the inner PTFE material of the adjustable catheter. In addition, the smooth surface of the stainless steel of the serpentine tube cannot achieve a tight fit with the outer material or the inner PTFE material. Therefore, material delamination may occur, which can lead to liquid leakage and inaccurate bending direction during use. This is not conducive to the smooth operation of the surgery and may pose a risk to the surgery. Summary of the Invention

[0003] The purpose of this invention is to treat the surface of the snake bone tube so that the snake bone tube can be tightly bonded to the inner or outer layer material, avoiding delamination.

[0004] To achieve the above objectives, in one aspect, the present invention provides a manufacturing process for an adjustable-bend conduit, the process comprising the following steps:

[0005] The surface of the snake bone tube is roughened;

[0006] The snake-bone tube is fitted onto an inner layer material;

[0007] An outer layer material is fitted onto the outer surface of the snake bone tube;

[0008] The tube is heated and shaped, and then cooled to obtain an adjustable bendable conduit.

[0009] Preferably, in the manufacturing process of the adjustable bendable conduit, the snake-bone tube is made of stainless steel, the inner layer material is made of PTFE, and the outer layer material is made of thermoplastic polymer.

[0010] Preferably, in the manufacturing process of the adjustable conduit, the thermoplastic polymer material includes one of PA12, Pebax, PU, ​​PEEK, HDPE or LDPE.

[0011] Preferably, in the manufacturing process of the adjustable bendable conduit, the roughening treatment includes one or more steps of forming a hydrophilic coating on the inner and outer surfaces of the snake-bone tube, performing plasma cleaning, electrolytic etching, electrolytic nitrogen fixation, polymer coating, or sandblasting.

[0012] Preferably, the process further includes the step of fixing the inner layer material onto a liner core, wherein the liner core is removed after the adjustable bend conduit is formed.

[0013] Preferably, in the manufacturing process of the adjustable bendable conduit, the heat setting includes the following steps:

[0014] Select heat shrink tubing with a suitable heat shrink ratio and heat shrink temperature based on the actual heat shrink effect required.

[0015] The heat shrink tubing is fitted onto the outer surface of the outer layer material;

[0016] Heat the material to set it.

[0017] Preferably, in the manufacturing process of the adjustable bendable conduit, after heating and shaping and cooling, the heat shrink tubing is removed.

[0018] Preferably, in the manufacturing process of the adjustable bendable conduit, the heat shrink tubing includes one of FEP, PTFE, PFA, or PET.

[0019] Preferably, in the manufacturing process of the adjustable bendable conduit, the heat shrink ratio of the heat shrink tubing is 1:1 to 2:1, and the heat shrink temperature range of the heat shrink tubing is 150 to 300°C.

[0020] On the other hand, the present invention also provides an adjustable bendable conduit, which is manufactured using the adjustable bendable conduit manufacturing process described above. The adjustable bendable conduit includes an inner layer material, a snake-bone tube, and an outer layer material; the inner layer material is attached to the inner surface of the snake-bone tube, and the outer layer material is attached to the outer surface of the snake-bone tube.

[0021] Compared with the prior art, the beneficial effects of the present invention are mainly reflected in:

[0022] 1. This invention enhances the surface roughness of the snake bone tube by roughening it, thereby enabling it to bond tightly with the inner and outer layer materials, thus ensuring the sealing and controllability of the bending tube.

[0023] 2. The present invention uses a snake-bone tube to replace the braided tube, which can enhance the support performance and simplify the later manufacturing process.

[0024] 3. The present invention selects heat shrink tubing that meets the requirements of heat shrink ratio and heat shrink temperature according to the needs, which can ensure the most suitable heat shrink effect, so that the thermoplastic polymer material is uniformly and stably covered on the outer surface of the snake tube, further ensuring its safety in use and meeting its appearance requirements. Attached Figure Description

[0025] Other features, objects, and advantages of the present invention will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings:

[0026] Figure 1 This is a first flowchart of the manufacturing process of the adjustable bendable conduit in one embodiment of the present invention;

[0027] Figure 2 This is a second flowchart of the manufacturing process of the adjustable bendable conduit in one embodiment of the present invention. Detailed Implementation

[0028] The adjustable bendable conduit and its manufacturing process according to the present invention will be described in more detail below with reference to the schematic diagrams, which illustrate preferred embodiments of the invention. It should be understood that those skilled in the art can modify the invention described herein while still achieving the advantageous effects of the invention. Therefore, the following description should be understood as being of general knowledge to those skilled in the art and is not intended to limit the invention.

[0029] For clarity, not all features of the actual embodiments are described. In the following description, well-known functions and structures are not detailed in detail, as they would obscure the invention with unnecessary detail. It should be understood that in the development of any actual embodiment, numerous implementation details must be made to achieve the developer's specific objectives, such as changes from one embodiment to another according to limitations related to the system or business. Furthermore, it should be understood that such development work may be complex and time-consuming, but is merely routine work for those skilled in the art.

[0030] The invention is described more specifically by way of example in the following paragraphs with reference to the accompanying drawings. The advantages and features of the invention will become clearer from the following description and claims. It should be noted that the drawings are in a very simplified form and use non-precise proportions, and are only used to facilitate and clarify the illustration of the embodiments of the invention.

[0031] As mentioned in the background section, existing adjustable-bend conduits using braided tubing as the support section cannot achieve adequate support performance. While using a serpentine tube as the support section can significantly improve support rigidity, the smooth surface of the serpentine tube cannot achieve a tight bond with the outer or inner PTFE material, resulting in material delamination. This leads to liquid leakage and inaccurate bending direction during use. Therefore, this invention designs an adjustable-bend conduit and its manufacturing process, which roughens the serpentine tube support section to achieve a tight bond with the inner and outer materials, avoiding delamination.

[0032] Please see Figure 1 On the one hand, this embodiment provides a manufacturing process for an adjustable bendable conduit, the process including the following steps:

[0033] The surface of the snake bone tube is roughened;

[0034] The snake-bone tube is fitted onto an inner layer material;

[0035] An outer layer material is fitted onto the outer surface of the snake bone tube;

[0036] The tube is heated and shaped, and then cooled to obtain an adjustable bendable conduit.

[0037] In this embodiment, the snake-bone tube is made of stainless steel, the inner layer material is made of PTFE, and the outer layer material is made of thermoplastic polymer material, including one of PA12, Pebax, PU, ​​PEEK, HDPE or LDPE.

[0038] Specifically, the roughening process includes one or more steps among forming a hydrophilic coating on the inner and outer surfaces of the snake tube, performing plasma cleaning, electrolytic etching, electrolytic nitrogen fixation, polymer coating, or sandblasting.

[0039] Hydrophilic coatings are surface treatment technologies that attract and absorb water molecules to improve the interaction between instruments and soft tissues. Hydrophilic coatings typically use hydrophilic polymers such as polyvinylpyrrolidone (PVP), polyacrylamide (PAM), polyethylene glycol (PEG), polyvinyl alcohol (PVA), and natural polysaccharides. These materials contain nonionic or ionic hydrophilic groups that can absorb large amounts of water to form a hydration layer, thereby endowing the coating with hydrophilicity and superlubricity, and also reducing the surface tension of the material to some extent.

[0040] Plasma cleaning removes contaminants at the molecular level by allowing active particles in plasma to interact physically or chemically with the material surface, while simultaneously roughening the surface microstructure. This treatment significantly improves the adhesion and wettability of the material surface. High-energy particles in the plasma can directly impact the surface of the serpentine tube, selectively dissociating atomic / molecular bonds based on differences in the material's physical phase and chemical structure. This process leads to the formation of active sites and changes in the surface morphology of the serpentine tube, thereby increasing surface roughness and enhancing the adhesion strength between the serpentine tube and other materials.

[0041] Electrolytic etching is an electrochemical surface treatment technique that increases surface roughness by applying direct current to a bath containing a specific electrolyte, creating a microscopic etching effect on the material surface. This technique is particularly suitable for improving the adhesion and biocompatibility of material surfaces. For example, in the medical device field, electrolytic etching of snake-shaped tubes can enhance their surface bonding with other materials. During electrolytic etching, the snake-shaped tube acts as the anode. Through an electrochemical reaction, metal ions on the anode dissolve into the electrolyte, simultaneously forming tiny etch pits on the material surface, increasing the surface's microscopic unevenness and thus improving surface roughness. This increased surface roughness helps coatings or other materials adhere better to the snake-shaped tube surface. The effectiveness of electrolytic etching is influenced by various parameters, including the type and concentration of the electrolyte, temperature, voltage, processing time, and the material of the snake-shaped tube. By precisely controlling these parameters, surface roughness of different degrees and characteristics can be obtained to meet the needs of specific applications. It has good precision and controllability, and can perform customized surface treatment for snake tubes of specific materials and shapes without damaging the overall structure and performance of the snake tube.

[0042] Electrolytic nitrogen fixation is a process that reduces nitrogen gas (N2) to ammonia (NH3) under specific electrochemical conditions. Electrolytic nitrogen fixation can typically alter the chemical composition and physical structure of a material's surface, affecting its surface properties, including roughness. For example, during electrolysis, certain compound layers may form on the surface of a serpentine tube, or the surface microstructure may be altered through electrochemical dissolution and deposition, thereby increasing surface roughness. This increased surface roughness may contribute to improving the bonding strength between the serpentine tube and other materials. In practical applications, other surface treatment techniques, such as electrolytic etching or plasma treatment, can be combined as needed to further enhance the surface roughness of the serpentine tube.

[0043] Polymer coating is a surface treatment technology that increases the surface roughness of a substrate such as a snake-bone tube by depositing a layer of polymer material on it. Firstly, the deposition process may create microstructures on the snake-bone tube surface, thus increasing surface roughness. Secondly, some coating techniques, such as chemical coating, form a non-uniform coating on the snake-bone tube surface, which also increases surface roughness, allowing the snake-bone tube to adhere tightly to both the inner and outer layer materials.

[0044] Sandblasting is a process that improves the surface roughness of a workpiece by using high-speed jets of abrasive particles to impact and cut the surface. This technology is particularly suitable for surface treatment of medical devices such as snake-bone tubes, improving their bonding strength with coatings or adhesives and enhancing their sealing and maneuverability. Sandblasting processes can be performed with varying roughness levels by changing the abrasive particle size. For example, for workpieces with coating thicknesses exceeding 0.25 mm, coarse abrasive is preferable to increase bonding strength; while for workpieces with coating thicknesses less than 0.25 mm, medium-coarse abrasive is preferred when a more uniform surface roughness is required.

[0045] In this embodiment, the manufacturing process of the adjustable bendable conduit further includes the step of: fixing the inner layer material onto a liner core, wherein the liner core is removed after the adjustable bendable conduit is formed.

[0046] In this embodiment, the heat setting includes the following steps:

[0047] Select heat shrink tubing with a suitable heat shrink ratio and heat shrink temperature based on the actual heat shrink effect required.

[0048] The heat shrink tubing is fitted onto the outer surface of the outer layer material;

[0049] Heat the material to set it.

[0050] In this embodiment, the heat shrink tubing includes one of FEP, PTFE, PFA, or PET, the heat shrink ratio of the heat shrink tubing is 1:1 to 2:1, and the heat shrink temperature range of the heat shrink tubing is 150 to 300°C. After shaping, the heat shrink tubing is removed after cooling.

[0051] During the heating and heat-shrinking shaping process, selecting heat-shrink tubing that meets the required heat-shrink ratio and temperature ensures the optimal heat-shrinking effect, guarantees the dimensional accuracy of the adjustable catheter, and allows the thermoplastic polymer material to uniformly and stably coat the outer surface of the serpentine tube, further ensuring its safety during use. Simultaneously, heat-shrinking shaping allows the catheter to be molded into specific shapes to adapt to different medical needs. Furthermore, the heating process helps improve the mechanical strength and flexibility of the adjustable catheter, thereby enhancing its durability and reliability during surgery.

[0052] On the other hand, this embodiment also provides an adjustable bend conduit, which is manufactured using the adjustable bend conduit manufacturing process described above. For details, please refer to [link / reference needed]. Figure 2 The adjustable bendable conduit includes an inner layer material, a snake-bone tube, and an outer layer material. The inner layer material is attached to the inner surface of the snake-bone tube, and the outer layer material is attached to the outer surface of the snake-bone tube.

[0053] In this embodiment, the snake-bone tube is made of stainless steel. The inner layer material is PTFE. The outer layer material is a thermoplastic polymer, including one of PA12, Pebax, PU, ​​PEEK, HDPE, or LDPE. The selection of these materials ensures that the thermoplastic polymer possesses excellent high-temperature resistance and chemical stability. Furthermore, heat shrink tubing with specific heat shrink ratios and temperatures can be selected based on the specific application of the adjustable-bend conduit to achieve suitable heat shrinkage effects.

[0054] In summary, the adjustable bending conduit and its manufacturing process proposed in this embodiment increase the surface roughness of the snake-bone tube through roughening treatment, thereby enabling a tight bond between it and the inner and outer layer materials, ensuring the sealing and controllability of the adjustable tube. Furthermore, this embodiment enhances support performance and simplifies subsequent manufacturing processes by using a snake-bone tube instead of a braided tube. Moreover, this embodiment selects heat-shrink tubing materials that meet the required heat shrink ratio and temperature, ensuring the most suitable heat shrink effect. This allows the thermoplastic polymer material to be uniformly and stably coated on the outer surface of the snake-bone tube, further ensuring its safety and meeting aesthetic requirements.

[0055] The above are merely preferred embodiments of the present invention and do not constitute any limitation on the present invention. Any equivalent substitutions or modifications made by those skilled in the art to the technical solutions and content disclosed in the present invention without departing from the scope of the present invention shall be deemed to have remained within the protection scope of the present invention.

Claims

1. A manufacturing process for an adjustable bendable conduit, characterized in that, The process includes the following steps: The surface of the snake bone tube is roughened; The snake-bone tube is fitted onto an inner layer material; An outer layer material is fitted onto the outer surface of the snake bone tube; The tube is heated and shaped, and then cooled to obtain an adjustable bendable conduit.

2. The manufacturing process of the adjustable bendable conduit according to claim 1, characterized in that, The snake-bone tube is made of stainless steel, the inner layer is made of PTFE, and the outer layer is made of thermoplastic polymer.

3. The manufacturing process of the adjustable bendable conduit according to claim 2, characterized in that, The thermoplastic polymer material includes one of PA12, Pebax, PU, ​​PEEK, HDPE or LDPE.

4. The manufacturing process of the adjustable bendable conduit according to claim 1, characterized in that, The roughening process includes one or more steps of forming a hydrophilic coating on the inner and outer surfaces of the snake tube, performing plasma cleaning, electrolytic etching, electrolytic nitrogen fixation, polymer coating, or sandblasting.

5. The manufacturing process of the adjustable bendable conduit according to claim 1, characterized in that, The process further includes the step of fixing the inner layer material onto a liner core, which is then removed after the adjustable bendable conduit is formed.

6. The manufacturing process of the adjustable bendable conduit according to claim 1, characterized in that, The heat setting process includes the following steps: Select heat shrink tubing with a suitable heat shrink ratio and heat shrink temperature based on the actual heat shrink effect required. The heat shrink tubing is fitted onto the outer surface of the outer layer material; Heat the material to set it.

7. The manufacturing process of the adjustable bendable conduit according to claim 6, characterized in that, After heating and shaping and cooling, the heat shrink tubing is removed.

8. The manufacturing process of the adjustable bendable conduit according to claim 6, characterized in that, The heat shrink tubing includes one of FEP, PTFE, PFA, or PET.

9. The manufacturing process of the adjustable bendable conduit according to claim 6, characterized in that, The heat shrink ratio of the heat shrink tubing is 1:1 to 2:1, and the heat shrink temperature range of the heat shrink tubing is 150 to 300°C.

10. An adjustable bend conduit, manufactured using the adjustable bend conduit manufacturing process as described in any one of claims 1-9, characterized in that, The adjustable bendable conduit includes an inner layer material, a snake-bone tube, and an outer layer material. The inner layer material is attached to the inner surface of the snake-bone tube, and the outer layer material is attached to the outer surface of the snake-bone tube.

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