Endoscope insertion section and endoscope insertion section manufacturing method

Abstract

The present application relates to an endoscope insertion part and a manufacturing method thereof, the endoscope insertion part comprising: a rigid outer tube having a receiving cavity; at least one inner tube inserted into the receiving cavity of the rigid outer tube to divide the receiving cavity into a plurality of working lumens; and a head end component fixed to one end of the rigid outer tube and having a plurality of through holes communicating with the working lumens; the endoscope insertion part forms a plurality of working lumens by inserting one or more inner tubes into the receiving cavity of the rigid outer tube, instead of the traditional integrated die-casting multiple lumen structure; the number and inner diameter of the inner tubes can be flexibly selected according to clinical requirements, without the need to configure a new die for each lumen, thereby significantly reducing the cost of the mold and shortening the product development and mass production response cycle.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an endoscope insertion part and a method for manufacturing an endoscope insertion part. Background Technology

[0002] Urinary tract stones (including kidney, ureteral, and bladder stones) are common diseases in urology. For larger or impacted stones, surgical intervention is often required. Rigid multi-lumen endoscopes are important auxiliary instruments for such surgeries. They typically have multiple working channels, including a water inlet, an instrument inlet, a holmium laser inlet, a pressure monitoring inlet, and a suction inlet. These are used for intraoperative irrigation and flushing to maintain a clear field of vision, instrument insertion to reduce the risk of inlet damage, laser fiber optic lithotripsy, real-time monitoring of intrarenal pressure to ensure surgical safety, and timely removal of bodily waste.

[0003] However, most commonly used insertion parts for endoscopes are made of stainless steel and manufactured as a single piece through die casting or drawing processes, requiring multiple steps such as heating, perforation, deformation, sizing, straightening, and hydrostatic testing. This process has several drawbacks: First, the mold costs are high, and adjustments to the number of cavities or the inner diameter require new molds, resulting in long development cycles and high investment; second, the flexibility in configuring working cavities is poor, making it difficult to quickly adjust to clinical needs after mass production of the insertion part, leading to slow product iteration response and poor economic efficiency; third, the choice of tip material is limited, as traditional insertion parts and tips are integrally molded and made of stainless steel, making it impossible to use softer materials with higher surface smoothness, affecting patient comfort. Summary of the Invention

[0004] Therefore, it is necessary to provide an endoscope insertion part and an endoscope insertion part manufacturing method to address the problems of high mold cost, inflexible cavity configuration adjustment, slow mass production response, and limited material selection for the tip of existing endoscopes.

[0005] On one hand, this application provides an endoscope insertion part, including: a rigid outer tube having a receiving cavity; at least one inner tube inserted into the receiving cavity of the rigid outer tube to divide the receiving cavity into multiple working channels; and a head end component fixed to one end of the rigid outer tube, and the head end component having multiple through holes communicating with the working channels.

[0006] In one embodiment, the working cavity includes one or more combinations of an infusion cavity, an instrument cavity, a pressure measurement cavity, a suction cavity, a camera cavity, and a holmium laser cavity.

[0007] In one embodiment, the head end includes a head end body and a connecting portion protruding from the head end body. The head end body has the through hole, the connecting portion has a connecting hole communicating with the through hole, and the connecting portion is inserted into the rigid outer tube, while the inner tube is inserted into the connecting hole.

[0008] In one embodiment, a filling medium is provided between the rigid outer tube and the inner tube.

[0009] In one embodiment, the head end component is fixedly connected to the rigid outer tube by adhesive bonding or welding.

[0010] In one embodiment, the inner tube is a plastic tube or a stainless steel tube.

[0011] On the other hand, this application also provides a method for manufacturing an endoscope insertion part, comprising the following steps: Select a rigid outer tube and at least one inner tube, wherein the outer diameter of the rigid outer tube corresponds to the outer diameter of the endoscope insertion part; the number and inner diameter of the inner tubes correspond to the number and inner diameter of the working cavities of the endoscope insertion part. The inner tube is inserted into the rigid outer tube to divide the receiving cavity of the rigid outer tube into multiple working channels; Manufacture a head end component, the head end component having a through hole corresponding to the working cavity; and; The head end component is spliced ​​to one end of the rigid outer tube so that the through hole communicates with the working cavity.

[0012] In one embodiment, in the step of manufacturing the head end component, which has a through hole corresponding to the working cavity, the head end component is injection molded by metal powder metallurgy or by plastic injection molding.

[0013] In one embodiment, the step of splicing the head end component to one end of the rigid outer tube, so that the through hole communicates with the working cavity, includes the following steps: Insert the inner tube into the connection hole of the head end component that communicates with the through hole; Insert the connecting part of the head end component into the rigid outer tube; and; Attach or weld the head end component and the rigid outer tube.

[0014] In one embodiment, after the step of splicing the head end component to one end of the rigid outer tube to connect the through hole with the working cavity, the method further includes the step of: A filling medium is injected between the rigid outer tube and the inner tube to fix the inner tube.

[0015] The endoscope insertion section of this application forms multiple working cavities by inserting one or more inner tubes into the receiving cavity of a rigid outer tube, replacing the traditional one-piece die-cast multi-cavity structure. The number and inner diameter of the inner tubes can be flexibly selected according to clinical needs, eliminating the need to re-mold for each cavity configuration, significantly reducing mold costs and shortening product development and mass production response cycles.

[0016] The headpiece and rigid outer tube of this application adopt a separate structure, and the two can be manufactured separately using different materials. The headpiece is no longer limited to stainless steel and can be made of smoother, more biocompatible materials, thereby improving the patient's comfort. Attached Figure Description

[0017] Figure 1 A schematic diagram of an endoscope insertion section provided in one embodiment of this application; Figure 2 An exploded view of the endoscope insertion section according to the above embodiment of this application is shown; Figure 3 A schematic diagram of the head end component of the endoscope insertion section according to the above embodiment of this application is shown; Figure 4 A schematic diagram illustrating the steps of a method for manufacturing an endoscope insertion part according to an embodiment of this application; Figure 5 A schematic diagram of step S400 of the method for manufacturing an endoscope insertion part according to the above embodiment of this application is shown; Figure 6 A schematic diagram of the steps following step S400 in the method for manufacturing an endoscope insertion part according to the above embodiment of this application is shown.

[0018] Figure label: 10. Rigid outer tube; 20. Inner tube; 30. Head end component; 31. Head end body; 32. Connecting part; 33. Through hole; 34. Connecting hole. Detailed Implementation

[0019] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0020] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used 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. Therefore, they should not be construed as limitations on this invention.

[0021] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0022] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0023] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0024] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0025] In view of the problems existing in the current endoscope insertion part, such as high mold cost, inflexible cavity configuration adjustment, slow mass production response and limited material selection for the tip, this application provides an endoscope insertion part and an endoscope insertion part manufacturing method.

[0026] Specifically, please refer to Figure 1 and Figure 2 The endoscope insertion section may include a rigid outer tube 10, at least one inner tube 20, and a tip component 30. The rigid outer tube 10 has a receiving cavity, and the inner tube 20 is inserted into the receiving cavity of the rigid outer tube 10, which can divide the receiving cavity into multiple working channels. The tip component 30 is fixed to one end of the rigid outer tube 10, and the tip component 30 has multiple through holes 33 communicating with the working channels.

[0027] Understandably, the endoscope insertion section of this application uses one or more inner tubes 20 inserted into the receiving cavity of the rigid outer tube 10 to form multiple working cavities, replacing the traditional one-piece die-cast multi-cavity structure. The number and inner diameter of the inner tubes 20 can be flexibly selected according to clinical needs, eliminating the need to re-mold for each cavity configuration, significantly reducing mold costs and shortening product development and mass production response cycles. Simultaneously, the tip component 30 and the rigid outer tube 10 adopt a separate structure, allowing for separate material selection and manufacturing. The tip component 30 is no longer limited to stainless steel and can be made of smoother, more biocompatible materials, improving patient comfort.

[0028] For example, when the endoscope insertion section includes one inner tube 20, the lumen of the inner tube 20 forms a working cavity, and the gap between the inner tube 20 and the rigid outer tube 10 forms another working cavity. When the endoscope insertion section includes multiple inner tubes 20, the lumen of each inner tube 20 forms a working cavity, and the gaps between adjacent inner tubes 20 and between the inner tube 20 and the rigid outer tube 10 can also form a working cavity. By adjusting the number of inner tubes 20 and the inner diameter of the inner tubes 20, multiple working cavities can be formed within the receiving cavity, and the cross-sectional shape and size of each working cavity can be freely designed according to functional requirements.

[0029] Optionally, in some embodiments, the working cavity may include one or more combinations of perfusion cavity, instrument cavity, pressure measurement cavity, suction cavity, imaging cavity, and holmium laser cavity. In other words, by flexibly configuring the number of inner tubes 20, multiple working cavities can be formed within the rigid outer tube 10, thereby enabling the endoscope insertion section to simultaneously meet multiple clinical functional requirements such as perfusion, instrument operation, pressure monitoring, waste suction, image acquisition, and laser lithotripsy, improving the clinical applicability and versatility of the product.

[0030] Optionally, in some embodiments, the rigid outer tube 10 may be made of stainless steel. Stainless steel has excellent corrosion resistance, exhibiting superior resistance to pitting and crevice corrosion from urine, saline, blood, and intraoperative irrigation fluids. Furthermore, the high rigidity of the stainless steel tube ensures structural stability of the endoscope insertion section, preventing deformation due to pressure from the walls of the body cavity.

[0031] Optionally, in some embodiments, the inner tube 20 may be made of plastic or stainless steel. Plastic tubes have a mature extrusion molding process and flexible tube diameter specifications, which facilitates rapid response to clinical customization needs. Stainless steel tubes have higher structural strength and can be processed into thinner tube walls, making the overall size of the endoscope insertion part smaller.

[0032] Optionally, such as Figure 2 and Figure 3 As shown, in some embodiments, the head end includes a head end body 31 and a connecting portion 32 protruding from the head end body 31. The head end body 31 has a through hole 33, and the connecting portion 32 has a connecting hole 34 communicating with the through hole 33. The connecting portion 32 is inserted into the rigid outer tube 10, and the inner tube 20 is inserted into the connecting hole 34. In this way, the head end component 30 and the rigid outer tube 10 are fixedly connected by the connecting portion 32, and the head end component 30 and the inner tube 20 are fixedly connected by the connecting hole 34. On the one hand, the head end component 30 can fix the inner tube 20 inside the rigid outer tube 10; on the other hand, it can realize the docking of the through hole 33 of the head end component 30 with the working cavity, and use the connecting portion 32 to seal the gap between the through hole 33 of the head end component 30 and the working cavity, so as to avoid intraoperative fluid leakage or cavity misalignment.

[0033] Optionally, in some embodiments, a filling medium is provided between the rigid outer tube 10 and the inner tube 20. This filling medium fills the gap between the inner tube 20 and the rigid outer tube 10, which can stably fix the inner tube 20 inside the rigid outer tube 10, preventing the inner tube 20 from shifting or shaking during the operation due to fluid impact or instrument friction, thereby ensuring the positional accuracy and structural stability of each working cavity and improving surgical safety.

[0034] Optionally, in some embodiments, the head end component 30 is fixedly connected to the rigid outer tube 10 by bonding or welding. The bonding or welding process is simple to operate, reliable in connection, and can achieve a firm fixation between the head end component 30 and the rigid outer tube 10. At the same time, the process is mature and easy to mass-produce and control in terms of quality.

[0035] On the other hand, such as Figure 4 As shown, this application also provides a method for manufacturing an endoscope insertion part, which is used to manufacture the aforementioned endoscope insertion part. The method for manufacturing the endoscope insertion part may include the following steps: S100. Select a rigid outer tube and at least one inner tube, wherein the outer diameter of the rigid outer tube corresponds to the outer diameter of the endoscope insertion part; the number and inner diameter of the inner tubes correspond to the number and inner diameter of the working cavities of the endoscope insertion part. S200. Insert the inner tube into the rigid outer tube to divide the receiving cavity of the rigid outer tube into multiple working cavities. S300, Manufacturing a head end component, the head end component having a through hole corresponding to the working cavity; and; S400. Connect the head end component to one end of the rigid outer tube so that the through hole communicates with the working cavity.

[0036] Following the steps outlined above, when manufacturing the endoscope insertion section, firstly, appropriate rigid outer and inner tubes of suitable specifications can be selected based on clinical needs. For example, a stainless steel tube can be used as the rigid outer tube, with its outer diameter and length determined according to the outer diameter of the endoscope insertion section. Simultaneously, inner tubes of corresponding numbers and inner diameters are selected based on the functions of the required working cavities. Then, the selected inner tubes are sequentially inserted into the receiving cavity of the rigid outer tube through openings at the front or rear end, thereby forming multiple independent working cavities within the rigid outer tube. Next, the tip component is prepared, with through holes corresponding to each working cavity created on it. Finally, the tip component is spliced ​​and fixed to the connecting part, ensuring precise communication between the through holes of the tip component and each working cavity, thus forming the endoscope insertion section.

[0037] In this way, the manufacturing process of the endoscope insert is broken down into multiple steps. The rigid outer tube, inner tube, and tip component can be selected and processed independently, eliminating the need for a complex multi-cavity integrated molding process. Workers only need to insert the inner tube into the outer tube and assemble the tip component onto the end of the outer tube to complete the main assembly. The production process is simple, the dependence on equipment and molds is greatly reduced, the mass production response speed is fast, and the production and manufacturing costs are significantly reduced.

[0038] Optionally, in some embodiments, in step S300, a head tip component is manufactured. This head tip component has a through hole corresponding to the working cavity. The head tip component is manufactured by metal powder metallurgy injection molding or by plastic injection molding. Powder metallurgy injection molding can produce a metal head tip with a precise structure and high strength, while plastic injection molding can produce a plastic head tip with a smooth surface, light weight, and good biocompatibility. Furthermore, the smooth surface of the plastic head tip can further improve patient comfort. The head tip material can be flexibly selected according to clinical needs.

[0039] Optionally, such as Figure 5 As shown, in some embodiments, step S400, splicing the head end component to one end of the rigid outer tube to make the through hole communicate with the working cavity, includes the following steps: S410. Insert the inner tube into the connection hole of the head end component that communicates with the through hole; S420, Insert the connecting portion of the head end component into the rigid outer tube; and; S430, Bond or weld the head end component and the rigid outer tube.

[0040] Following the steps outlined above, first align each inner tube with the connecting hole on the connecting part of the tip component, and insert the inner tubes one by one into the connecting holes. This ensures that the cavity of each inner tube communicates with the corresponding through hole in the connecting hole. On one hand, the inner diameter of the connecting hole matches the outer diameter of the inner tube, securing it in place. On the other hand, the tight fit between the inner wall of the connecting hole and the outer wall of the inner tube forms a seal, preventing intraoperative fluid leakage along the outer wall of the inner tube. Next, move the tip component with the inserted inner tubes to the distal end of the rigid outer tube, inserting the connecting part into the rigid outer tube, ensuring that the outer wall of the connecting part fits the inner wall of the rigid outer tube. Finally, secure the tip component and the rigid outer tube using other mechanical fixation methods such as bonding or welding. For example, medical adhesive can be applied to the connecting part of the tip component, or an annular groove can be created on the outer wall of the connecting part to accommodate sealant, ensuring a tight connection between the tip component and the rigid outer tube.

[0041] Optionally, such as Figure 6 As shown, in some embodiments, after step S400, where the head end component is spliced ​​to one end of the rigid outer tube to connect the through hole with the working cavity, the following step is further included: S500. Inject a filling medium between the rigid outer tube and the inner tube to fix the inner tube.

[0042] Following the steps described above, a filling medium is injected between the rigid outer tube and the inner tube. After the filling medium solidifies or solidifies, it can fix the inner tube in the cavity of the rigid outer tube, thereby improving the structural stability of the endoscope insertion part and preventing the inner tube from shaking due to instrument interference or fluid flow impact during the operation.

[0043] By way of example, referring to the preparation of the endoscope insertion portion described above, this application also provides specific examples of the endoscope insertion portion.

[0044] For example, an endoscope insertion section. A stainless steel tube with an outer diameter of 3.5 mm and a wall thickness of 0.25 mm is selected as the rigid outer tube. Four inner tubes are selected: the first is a stainless steel tube with an outer diameter of 1.6 mm and a wall thickness of 1.2 mm, used as the instrument channel; the second is a plastic tube with an outer diameter of 1.0 mm and an inner diameter of 0.6 mm, used as the holmium laser channel; the third is a stainless steel tube with an outer diameter of 0.7 mm and an inner diameter of 0.4 mm, used as the pressure measurement channel; and the fourth is a plastic tube with an outer diameter of 1.0 mm and an inner diameter of 0.6 mm, used as the camera channel. The four inner tubes are inserted into the receiving cavity of the rigid outer tube, and a head end component is spliced ​​to one end of the rigid outer tube. The head end component has four through holes, which serve as the instrument hole, laser hole, pressure measurement hole, and camera hole, respectively. The instrument hole communicates with the instrument channel, the laser hole communicates with the holmium laser channel, the pressure measurement hole communicates with the pressure measurement channel, and the camera hole communicates with the camera channel. After assembly, medical adhesive is used to bond the end components and the rigid outer tube, thus obtaining the endoscope insertion section. This endoscope insertion section can be used for urinary system stone surgery and can meet the needs of instrument operation, laser lithotripsy, and pressure measurement.

[0045] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0046] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. An endoscope insertion part, characterized in that, include: A rigid outer tube having a receiving cavity; At least one inner tube, inserted into the receiving cavity of the rigid outer tube, to divide the receiving cavity into multiple working channels; and The head end component is fixed to one end of the rigid outer tube, and the head end component has multiple through holes communicating with the working cavity.

2. The endoscope insertion section according to claim 1, characterized in that, The working cavity includes one or more combinations of infusion cavity, instrument cavity, pressure measurement cavity, suction cavity, camera cavity and holmium laser cavity.

3. The endoscope insertion section according to claim 1, characterized in that, The head end includes a head end body and a connecting part protruding from the head end body. The head end body has the through hole, and the connecting part has a connecting hole communicating with the through hole. The connecting part is inserted into the rigid outer tube, and the inner tube is inserted into the connecting hole.

4. The endoscope insertion section according to any one of claims 1 to 3, characterized in that, A filling medium is provided between the rigid outer tube and the inner tube.

5. The endoscope insertion section according to any one of claims 1 to 3, characterized in that, The head end component is fixedly connected to the rigid outer tube by adhesive bonding or welding.

6. The endoscope insertion section according to any one of claims 1 to 3, characterized in that, The inner tube is a plastic tube or a stainless steel tube.

7. A method for manufacturing an endoscope insertion part, characterized in that, Includes the following steps: Select a rigid outer tube and at least one inner tube, wherein the outer diameter of the rigid outer tube corresponds to the outer diameter of the endoscope insertion part; the number and inner diameter of the inner tubes correspond to the number and inner diameter of the working cavities of the endoscope insertion part. The inner tube is inserted into the rigid outer tube to divide the receiving cavity of the rigid outer tube into multiple working channels; Manufacture a head end component, the head end component having a through hole corresponding to the working cavity; and The head end component is spliced ​​to one end of the rigid outer tube so that the through hole communicates with the working cavity.

8. The method for manufacturing an endoscope insertion part according to claim 7, characterized in that, In the step of manufacturing the head end component, which has a through hole corresponding to the working cavity, the head end component is formed by metal powder metallurgy injection molding or by plastic injection molding.

9. The method for manufacturing an endoscope insertion part according to claim 7, characterized in that, The step of splicing the head end component to one end of the rigid outer tube, so that the through hole communicates with the working cavity. Includes the following steps: Insert the inner tube into the connection hole of the head end component that communicates with the through hole; The connecting part of the head end component is inserted into the rigid outer tube; and Attach or weld the head end component and the rigid outer tube.

10. The method for manufacturing an endoscope insertion part according to claim 7, characterized in that, After the step of splicing the head end component to one end of the rigid outer tube to make the through hole communicate with the working cavity, the following step is also included: A filling medium is injected between the rigid outer tube and the inner tube to fix the inner tube.

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