A visual catheter and method of making the same

Abstract

The application relates to a visible catheter and a manufacturing method thereof, the visible catheter comprising a tube body and a visible module, the tube body being provided with an axial channel, and an axial mounting groove being concavely arranged on a distal end wall surface of the tube body; the visible module being fixed to the mounting groove, a projection of the visible module on a tube body section being overlapped with a tube body wall surface, the module comprising a module main body composed of an image acquisition unit and an illumination unit, and a row-type micro cable being peripherally attached to the tube body wall surface, the cable being electrically connected with each unit one by one and deviating from a central axis of the corresponding unit. According to the application, the visible module and the tube wall space of the tube body are shared, the radial occupation size is reduced, the off-axis linear arrangement of the row-type micro cable further reduces the radial thickness, the channel inside the tube body can be maximized in space, a larger channel can be realized under the same outer diameter, the removal speed of stones is accelerated, and more energy output and damage caused by stone powderization due to insufficient space are reduced.

Description

Technical Field

[0001] This application relates to the field of endoscopy technology, and in particular to a visual catheter and its manufacturing method. Background Technology

[0002] Current endoscopes are mainly formed by connecting multi-lumen tubes with directional serpentine structures. The insertion part often uses a combination of multi-lumen extruded tubes, braided tubes, and serpentine structures, with the outer layer wrapped in polymer. Module cables, directional guide wires, water guides, and forceps are inserted into different lumens of the multi-lumen tube. All inserted components are integrated at the handle to form an operating visual guide tube. The tip is sealed with a sealing cap, forming the endoscope lens end, which includes a light source, camera, and forceps outlet.

[0003] For example, the endoscope structures disclosed in Chinese patent CN208625650U and international patent WO2019049506A1 both use a packaged end connected to a multi-lumen tube. The packaged end is provided with an endoscope channel, a light source mounting hole, an instrument channel, etc., and the cable and the adjustment structure are connected to the operating end through the multi-lumen tube.

[0004] However, in this traditional structural design, the construction of the insertion section results in a large amount of internal space being occupied by the multi-cavity layout of the endoscope, severely limiting the space for the forceps and compressing the effective passage for instruments. The space ratio (i.e., the ratio of the forceps diameter to the maximum outer diameter of the endoscope tip) is an important indicator of endoscope space utilization. With a fixed outer diameter, the larger the forceps diameter, the larger this ratio. Traditional designs have a small space ratio. For example, the commonly used flexible ureteroscope with an outer diameter of 2.7 mm has a forceps diameter of only 1.2 mm, a diameter ratio of 1.2:2.7≈0.444, and a cross-sectional area ratio of approximately 0.1975. Such a small forceps space not only prolongs the lithotripsy operation time and reduces the efficiency of stone removal, but also leads to increased water pressure in the surgical field, often requiring the use of a sheath, further increasing the risk of damage to the body's natural cavities. Summary of the Invention

[0005] This application provides a visual catheter and its manufacturing method to solve the problem in related technologies where the structural design and manufacturing process of endoscopes with multi-lumen extrusion tubes, braided tubes and snake bone splices result in a large compression of the forceps channel space and an extremely small space ratio, which in turn affects surgical efficiency and increases the risk of injury to patients.

[0006] In a first aspect, a visual catheter is provided, comprising: A tube body having a proximal end and an opposite distal end, wherein an axial channel is formed within the tube body, and at least one axially extending mounting groove is recessed on the wall surface of the distal end of the tube body. A visual module is fixedly installed in the mounting groove, and its projection on the cross-section of the tube overlaps with the wall surface of the tube. The visual module includes: - The module body includes multiple visual units and an encapsulation part that encapsulates the visual units; - A row of micro-cables, comprising multiple cables arranged linearly, the row of micro-cables being attached to the wall of the tube body along the circumference and extending axially; each cable is electrically connected to each of the visual units in a one-to-one correspondence, and each cable is offset from the central axis of the corresponding visual unit.

[0007] In some embodiments, the cross-sectional shape of the visual module on the radial section of the conduit is L-shaped or T-shaped.

[0008] In some embodiments, a protective sleeve is fitted over the outside of the tube body and covers the head end of the visual module within the mounting groove.

[0009] In some embodiments, the flexibility of the tube varies along the tube axis, and the flexibility of the distal portion is greater than that of the proximal portion.

[0010] In some embodiments, the distal end of the tube body is provided with a bend, the bend comprising: A reed tube, fixed inside the tube; At least two directional wires are symmetrically arranged on the radial outer / inner side of the reed tube. The distal end of each directional wire is fixedly connected to the reed tube, and the connection point is spaced apart from the distal end face of the reed tube by a distance. The proximal end of each directional wire extends toward the proximal end of the tube body.

[0011] In some embodiments, the tube body is provided with a plurality of limiting holes in the circumferential direction. The number of limiting holes is the same as the number of directional wires and their positions correspond. Each limiting hole penetrates the tube body along the axial direction of the tube body, and the directional wire passes through the corresponding limiting hole.

[0012] In some embodiments, the reed tube extends through the channel along the axis of the tube body, and the directional wire is located between the reed tube and the inner wall of the tube body.

[0013] In some embodiments, the reed tube is disposed within the channel and extends axially along the tube body; the pitch of the reed tube varies axially, with the pitch at the distal end being greater than the pitch at the proximal end.

[0014] Secondly, a method for manufacturing a visual catheter is provided, comprising the following steps: Prepare a tube body, and recess at least one axially extending mounting groove on the wall surface at the distal end of the tube body; To prepare a visual module, multiple visual units are placed inside an encapsulation section, and a medium is filled in the area where the visual unit is connected to the cable and located within the encapsulation section. The cables are pushed to one side of the inner wall of the encapsulation part by the squeezing action during the filling of the medium, so that the cables are arranged in sequence along the circumferential direction of the encapsulation part, thereby deviating from the central axis of the module body and forming a row of micro cables. The visual module is fixedly installed in the mounting groove, and the projection of the visual module on the cross section of the tube overlaps with the tube wall. The row of micro-cables is attached to the tube wall along the circumference of the tube.

[0015] In some embodiments, the method for preparing the tube includes: Prepare a reed tube and fix at least two directional wires at a distance from the distal end of the reed tube, with the directional wires located on the radial outer / inner side of the reed tube; The reed tube can be fixedly connected to the tube body using one of the following methods: Limiting holes corresponding to the number and position of the directional wires are opened on the wall of the tube. Each limiting hole penetrates the tube along the axial direction of the tube. The directional wires are inserted into the corresponding limiting holes. The tube and the reed tube are fused at the interface by hot melt coating process. After the tube is expanded, it is fitted onto the outer circumference of the reed tube and the directional wire. The elastic restoring force of the tube is used to form an interference fit, so that the two are fixedly connected. After the reed tube is fixedly connected to the tube body, at least one axially extending mounting groove is recessed on the wall surface at the far end of the tube body.

[0016] This application provides a visual conduit and its manufacturing method, which eliminates the traditional serpentine structure. By fixing the visual module in a recessed mounting groove on the distal wall of the tube body and making the projection of the visual module on the tube body cross section overlap with the tube body wall, the visual module and the tube body wall share part of the space. Structurally, this significantly reduces the radial dimension occupied by the visual module and reserves more effective space for the internal channel of the tube body. Traditional visual catheters employ a multi-tube structure, requiring cables to pass through multiple cavities. The overall cross-section is circular, and its radial thickness is the sum of the tube wall thickness and the thickness of multiple cables, resulting in a large space occupation. In contrast, this application designs the visual module as an off-axis structure, with a row of micro-cables attached to the inner or outer wall along the circumference of the tube. This reduces the radial thickness to only the sum of the tube wall thickness and the thickness of a single cable. Under the premise of the same outer diameter of the visual catheter, it can both reduce the radial dimension of the catheter tip and significantly expand the space of the internal operating channel, effectively improving the space ratio. This provides a larger passage for surgical instruments, reduces patient pain, and minimizes invasive damage to the body's natural cavities. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the tube structure in Embodiment 1 provided in this application. Figure 2 Schematic diagram of the visual module structure in Embodiment 1 provided for the embodiments of this application Figure I ; Figure 3 Schematic diagram of the visual module structure in Embodiment 1 provided for the embodiments of this application Figure II ; Figure 4 for Figure 2 Schematic diagram of the cross-sectional structure of the central visual module; Figure 5 This is a schematic diagram of the visual module packaging structure provided in the embodiments of this application; Figure 6 Schematic diagram of the assembly structure of the tube body and the visual module in Embodiment 1 provided for the embodiments of this application. Figure I ; Figure 7 Schematic diagram of the assembly structure of the tube body and the visual module in Embodiment 1 provided for the embodiments of this application. Figure II ; Figure 8 This is a cross-sectional structural diagram of Embodiment 1 provided in this application. Figure 9 This is a schematic diagram of the tube structure in Embodiment 2 provided in this application. Figure 10 This is a schematic diagram of the reed tube structure in Embodiment 2 provided in this application. Figure 11 A partially enlarged view of the assembly relationship in Embodiment 2 provided for the purposes of this application; Figure 12 This is a schematic diagram of the assembled tube body of Embodiment 2 provided in this application. Figure 13 Schematic diagram of the reed tube structure in Embodiment 3 provided for the embodiments of this application Figure I ; Figure 14 Schematic diagram of the reed tube structure in Embodiment 3 provided for the embodiments of this application Figure II ; Figure 15 This is a schematic diagram of the structure of the tube body after assembly, as provided in Embodiment 3 of this application.

[0019] In the diagram: 1. Tube body; 101. Channel; 102. Mounting groove; 103. Limiting hole; 2. Bending part; 201. Spring tube; 202. Directional wire; 3. Visual module; 301. Module body; 3011. Image acquisition unit; 3012. Illumination unit; 3013. Encapsulation part; 3014. Filling part; 302. Row-shaped micro cable; 3021. Cable; 4. Protective sleeve; 5. Rheological coating layer. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0021] Current endoscopic insertion sections mostly employ a multi-tube bundle structure encapsulated in polymers such as PVC and silicone. Because each tube bundle in this multi-tube design occupies a certain radial thickness, the stacked tubes significantly compress the internal instrument channel, resulting in extremely low effective space. This is a core contributing factor to various complications in endoscopic surgery. Taking urinary endoscopes as an example, due to the narrow instrument channel, lithotripsy requires the stones to be completely pulverized to an extremely small size before removal. This not only consumes more energy and significantly prolongs the operation time but also increases the operational risk, easily leading to various surgical complications and causing harm to the patient.

[0022] Analysis revealed that the root cause of these problems lies in the fact that traditional visual catheters integrate multiple functional components, each occupying an independent cavity, resulting in a bulky structure and redundant wall thickness. Specifically, the visual module, directional wire, and cables in traditional structures are installed using a multi-tube approach, with the cable cross-section arranged in a circular pattern. The radial thickness is equal to the thickness of the tube wall stacked with multiple cables, severely compressing the internal operating space. If the spatial layout of the visual module and tube can be optimized while maintaining the same outer diameter, reducing the radial thickness occupied by the cable arrangement, the internal channel size can be effectively increased, improving the space ratio. Stones would then no longer need to be pulverized to an ultra-fine size; they could be removed simply by crushing them, thereby improving surgical efficiency and reducing the risk of injury to the patient.

[0023] This application provides a visual catheter that solves the problem in related technologies where the endoscope's structural design and manufacturing process, which limits the connection between multi-lumen extrusion tubes, braided tubes, and snake-bone joints, results in a large compression of the forceps channel space and an extremely small space ratio, thereby affecting surgical efficiency and increasing the risk of injury to the patient.

[0024] Firstly, such as Figures 1 to 8As shown, this application provides a visual catheter, comprising: The tube body 1 has a proximal end and a relatively distal end. A channel 101 is formed in the tube body 1 along the axial direction. The channel 101 can be used as a channel for instrument operation or as a waterway. At least one axially extending mounting groove 102 is recessed on the wall surface of the distal end of the tube body 1. The visual module 3 is fixedly installed in the mounting groove 102, and its projection on the cross-section of the pipe body 1 overlaps with the pipe body 1. The visual module includes: - Module body 301 includes multiple visual units encapsulated in encapsulation part 3013, the multiple visual units including image capturing unit 3011 and illumination unit 3012; - A row of micro-cables 302 includes multiple cables 3021, which are attached to the wall of the tube 1 along the circumference and extend along the axial direction; each cable 3021 is electrically connected to each visual unit in a one-to-one correspondence, and each cable 3021 is offset from the central axis of the module body.

[0025] In some embodiments, such as Figure 6 As shown, the row-shaped micro-cable 302 is fixedly installed on the inner wall of the tube body 1; in other embodiments, such as Figure 7 As shown, the row-shaped micro-cable 302 is fixedly installed on the outer wall of the tube 1. Two flexible installation methods are provided, which can be adapted to the outer diameter requirements of the endoscope, the application scenario, and the assembly process. The inner wall installation can utilize the gap inside the tube without increasing the overall outer diameter of the endoscope, which is suitable for cavities with strict requirements for the diameter of the endoscope. The outer wall installation reduces the processing and assembly difficulty of the inner wall of the tube, and facilitates later inspection and maintenance. Both methods can ensure the fixed stability of the row-shaped micro-cable and minimize the radial space occupied in the channel.

[0026] This application eliminates the traditional snake-bone structure. By fixing the visual module in a recessed mounting groove 102 on the distal wall of the tube body, and making the projection of the visual module 3 on the cross-section of the tube body 1 overlap with the wall of the tube body 1, a portion of the space between the visual module and the tube wall is shared. Structurally, this reduces the radial dimension occupied by the visual module 3, reserving more effective space for the internal channel of the tube body 1. Traditional visual catheters use a multi-tube structure, requiring cables to pass through multiple cavities. The overall cross-section is circular, and its radial thickness is the thickness of the tube wall plus the thickness of multiple cables, occupying a large space. In contrast, this application designs the visual module as an off-axis structure, with the row of micro-cables attached to the inner or outer wall of the tube body circumferentially. This makes the radial thickness only the thickness of the tube wall plus the thickness of a single cable. Under the premise of the same outer diameter of the visual catheter, it can not only reduce the radial dimension of the catheter end, but also significantly expand the space of the internal operating channel of the tube body, effectively improving the space ratio. This provides a larger passage for surgical instruments, reduces patient pain, and reduces invasive damage to the body's natural cavities.

[0027] Furthermore, the cross-sectional shape of the visual module 3 in the radial section of the conduit is L-shaped or T-shaped. In this embodiment, an L-shaped visual module 3 is used, that is, the module body 301 and the row-shaped micro cable 302 are arranged perpendicularly, and the row-shaped micro cable 302 is arranged at the radial end of the module body 301. This can effectively reduce the space occupied by the visual module in the radial direction of the conduit. At the same time, the row-shaped micro cable 302 fits against the wall of the pipe body 1, and the installation is stable.

[0028] In some alternative embodiments, the visual module 3 adopts an asymmetrical T-shaped structure, that is, the module body 301 has a T-shaped profile in the radial section, and the row-shaped micro-cable 302 is arranged in the longitudinal extension section of the T-shaped structure and is offset from the center of the module body 301.

[0029] Furthermore, it also includes: The protective sleeve 4 is fitted over the outside of the tube body 1 and covers the head end of the visual module 3 within the mounting groove 102. It effectively protects the key parts of the visual module, preventing damage or detachment of the visual module due to friction, squeezing, or contact with bodily fluids during tube pushing or bending, extending its service life, and improving safety and imaging stability during use.

[0030] Furthermore, the flexibility of the tube body 1 varies along the axial direction, with the distal portion exhibiting greater flexibility than the proximal portion. By varying the flexibility of the tube body along the axial direction, and ensuring greater flexibility at the distal end than at the proximal end, the distal end of the catheter can more easily conform to the curvature of the body's natural cavities, reducing tissue damage. Simultaneously, the proximal end maintains good pushability and maneuverability, achieving a balance between flexible guidance and precise positioning of the catheter.

[0031] Furthermore, the distal end of the tube body 1 is provided with a bend 2, the bend 2 including: The reed tube 201 is fixed inside the tube body 1; At least two directional wires 202 are symmetrically arranged on the radial outer or inner side of the reed tube 201. The distal end of each directional wire 202 is fixedly connected to the reed tube 201, and the connection point is spaced apart from the distal end face of the reed tube 201 by a distance. The proximal end of each directional wire 202 extends toward the proximal end of the tube body 1.

[0032] By setting a reed tube 201 at the distal end of the catheter body and symmetrically arranging at least two directional wires 202 on its radial outer side, with the distal end of the directional wire 202 fixedly connected to the reed tube 201 and the connection point spaced apart from the distal end face by a distance, such as 3-10mm, the directional wire 202 can drive the reed tube 201 to bend in a specific direction when under tension, thereby achieving active deflection control of the distal end of the catheter 1, improving the guiding ability of the catheter 1 and the operability to reach complex lesion sites.

[0033] In some alternative embodiments, the directional wire 202 is provided with 3 or 4 wires, which can realize multi-directional bending control and meet the diverse needs for bending direction and angle in different surgical scenarios.

[0034] Furthermore, the tube body 1 is provided with a plurality of limiting holes 103 in the circumferential direction. The number of limiting holes 103 is the same as the number of directional wires 202 and their positions correspond. Each limiting hole 103 penetrates the tube body 1 along the axial direction of the tube body 1, and the directional wire 202 is inserted into the corresponding limiting hole 103.

[0035] In some embodiments, by providing multiple limiting holes 103 in the circumference of the tube body 1, which are the same number and corresponding in position as the directional wires 202, and by having the directional wires 202 pass through the corresponding limiting holes 103, the axial movement of the directional wires 202 can be constrained and guided, preventing the directional wires 202 from shifting, tangling or crossing during bending or pushing, ensuring the accurate transmission of the directional force, and improving the stability and reliability of bending control.

[0036] Furthermore, the reed tube 201 passes through the channel 101 along the axis of the tube body 1, and the directional wire 202 is located between the reed tube 201 and the inner wall of the tube body 1. By having the reed tube pass through the channel along the axis of the tube body and the directional wire located between the reed tube and the inner wall of the tube body, on the one hand, the reed tube passes through the entire tube body axially, providing structural support and bending guidance for the tube body throughout the entire process, ensuring stable mechanical transmission performance of the guide tube during the pushing process; on the other hand, by arranging the directional wire in the gap between the reed tube and the inner wall of the tube body, there is no need to open an additional independent directional wire channel on the tube body, simplifying the structural design of the tube body, avoiding the increase in tube wall thickness or the occupation of internal channel space due to the opening of limiting holes, thereby further releasing the internal volume of the channel within a limited outer diameter and improving the space ratio.

[0037] Furthermore, the reed tube 201 is disposed within the channel 101 and extends axially along the tube body 1; the pitch of the reed tube 201 varies axially, with the pitch at the distal end being greater than that at the proximal end. By disposing the reed tube 201 within the channel and varying its pitch axially, with the distal pitch being greater than the proximal pitch, the reed tube 201 achieves greater bending flexibility and a smaller bending radius at the distal end, while maintaining good structural strength and pushing stiffness at the proximal end. This optimizes the bending performance of the distal end of the catheter 1, satisfying the requirements for passage through complex anatomical pathways while ensuring overall pushing efficiency and operational stability.

[0038] The following three examples illustrate the fabrication method of the visual catheter of this application.

[0039] Example 1 S100: Prepare a tube body 1, and provide at least one axially extending mounting groove 102 recessed on the wall surface at the distal end of the tube body 1.

[0040] like Figure 1 As shown, the tube body 1 is made of polymer materials (such as silicone, PVC, PEEK, etc.). The tube body 1 has a proximal end and a relatively distal end. The proximal end is the end closer to the operator's handle, and the distal end is the end closer to the working part inside the patient's body. An axial channel 101 is formed inside the tube body 1, and an axially extending mounting groove 102 is recessed on the wall surface of the distal end of the tube body 1 for mounting the visual module 3.

[0041] S200: Prepare visual module 3.

[0042] In this embodiment, the visual module 3 includes a module body 301 and a row-shaped microcable 302. The module body 301 includes an encapsulation portion 3013 and multiple visual units, such as... Figure 2 and Figure 4 As shown, the multiple viewing units can be arranged in various ways, including a linear arrangement or a triangular arrangement. Specifically, each viewing unit consists of an image capturing unit 3011 and illumination units 3012 located on either side of the image capturing unit 3011. The encapsulation unit 3013 houses the multiple viewing units, and the length of each viewing unit is shorter than the length of the encapsulation unit 3013, ensuring that the cable portion connected to the end of each viewing unit is located inside the encapsulation unit 3013.

[0043] By filling the encapsulation section 3013 with adhesive to form a filling section, the extrusion action of the adhesive during filling pushes the cable 3021 to one side of the inner wall of the encapsulation section 3013, causing the cable 3021 to be arranged sequentially along the circumferential direction of the encapsulation section 3013, thereby deviating from the central axis of the module body 301 to form a row of micro-cables 302. The structure after encapsulation is as follows. Figure 2 As shown, its shape on the radial section of tube 1 is as follows: Figure 3 and Figure 8 As shown.

[0044] In this embodiment, the cross-section after packaging is L-shaped. In some alternative embodiments, the cross-section after packaging can also be asymmetrical T-shaped.

[0045] In this embodiment, the encapsulation part 3013 is a microtube only a few millimeters in length with a rectangular cross-section. In some alternative embodiments, the cross-section of the microtube may also be circular.

[0046] In some alternative embodiments, the encapsulation portion 3013 may also be encapsulated with adhesive.

[0047] S300: The visual module 3 is fixedly installed in the mounting groove 102, and the projection of the visual module 3 on the cross section of the tube body 1 overlaps with the wall surface of the tube body 1.

[0048] In this embodiment, as Figure 6 As shown, the visual module 3 is fixedly installed in the mounting groove 102, the diameter of which is not greater than the outer diameter of the visual module 3. The row-shaped micro-cable 302 is fixedly installed on the inner wall of the tube body 1; in other embodiments, such as Figure 7 As shown, the row-shaped micro-cable 302 is fixedly installed on the outer wall of the tube 1. Two flexible installation methods are provided, which can be adapted to the outer diameter requirements of the endoscope, the application scenario, and the assembly process. The inner wall installation can utilize the gap inside the tube without increasing the overall outer diameter of the endoscope, which is suitable for cavities with strict requirements for the diameter of the endoscope. The outer wall installation reduces the processing and assembly difficulty of the inner wall of the tube, and facilitates later inspection and maintenance. Both methods can ensure the fixed stability of the row-shaped micro-cable and minimize the radial space occupied in the channel.

[0049] S400: such as Figure 8 As shown, according to actual usage requirements, a protective sleeve 4 can be fitted over the outside of the tube body 1. The protective sleeve 4 is made of medical flexible sealing material. After being fitted, it completely covers the visual module 3 in the mounting groove 102. Then, the protective sleeve 4 is fixed to the tube body 1 by heat shrinking, bonding and other methods to ensure that the protective sleeve 4 is firmly installed and reliably sealed, so as to achieve comprehensive protection of the tube body 1, the visual module 3 and the internal precision components. At the same time, it optimizes the smoothness of the outer surface of the visual catheter and reduces friction damage to the patient's internal tissues.

[0050] The order of steps S100 and S200 can be reversed; for example, the visible module 3 can be manufactured first, followed by the tube body 1. This can be flexibly adjusted according to production process arrangements and production efficiency requirements without affecting the structure and performance of the final product.

[0051] Endoscopes are classified into two types based on their application scenarios: fixed-angle endoscopes, which do not require angle adjustment via the handle and only require the tube body 1 to have a certain degree of flexibility; and adjustable-angle endoscopes, which require large-angle flexible adjustments to adapt to complex cavity diagnosis and treatment. Examples 2 and 3 will be used to illustrate the use of endoscopes requiring large-angle adjustments.

[0052] Example 2 like Figures 9 to 11As shown, the difference between this embodiment and Embodiment 1 is that, in step S100 when preparing the tube body 1, a curved portion 2 needs to be prepared inside the tube body. The curved portion 2 is located at the distal end of the tube body 1 and is entirely located within the channel 101. The curved portion 2 includes a coiled tube 201, which is made by winding and weaving nickel-titanium alloy or stainless steel wire around a mandrel to form a tube body with a spring-like structure. Firstly, the coiled tube 201 is made using a metal wire winding process, which combines flexibility and structural strength, and can achieve flexible bending deformation. Secondly, by embedding the curved portion 2 entirely within the channel 101 and using the design of the tube body 1 covering the coiled tube 201, the independently oriented metal coiled tube 201 is made to achieve uniform wall thickness forming, eliminating the thickness of the oriented serpentine joint, avoiding the additional axial and radial space occupied when the traditional serpentine structure is joined to the tube body 1, and further improving the utilization rate of the internal space of the tube body. Thirdly, the selection of nickel-titanium alloy and stainless steel materials ensures the fatigue resistance and biocompatibility of the curved portion, making it suitable for the use scenarios of medical devices.

[0053] like Figure 10 As shown, two (or three, four) directional wires 202 are anchored radially outside the reed tube 201 to control the bending of the curved section 2. The two directional wires 202 are circumferentially symmetrically arranged on both sides of the reed tube 201. The distal end of each directional wire 202 is fixedly connected to the distal end of the reed tube 201 at a distance (e.g., by welding), and the proximal end of each directional wire 202 extends towards the proximal end of the tube body 1 for connection to the control mechanism at the handle end. Through the symmetrical arrangement of the directional wires 202, precise control of the direction of the curved section 2 is achieved, allowing the operator to flexibly adjust the endoscope angle according to the intracavitary anatomical structure, thus improving the accuracy and adaptability of the surgical operation.

[0054] like Figure 9 As shown, the tube body 1 has two limiting holes 103 circumferentially. The number of limiting holes 103 is the same as the number of directional wires 202 and their positions correspond. Each limiting hole 103 penetrates the tube body 1 along its axial direction so that the corresponding directional wire 202 can pass through it. The limiting holes 103 can precisely limit the directional wire 202 to a specific position circumferentially of the tube body 1, preventing the directional wire 202 from shifting or tangling during use, and ensuring that the bending part 2 can bend precisely in the preset direction.

[0055] After the tube body 1 and the bend 2 are installed, a non-metallic rheological coating layer 5 is applied to the portion of the directional wire 202 exposed outside the tube body 1 and the outermost layer of the distal end of the tube body 1 using a hot-melt coating process. Figure 11 As shown, the reed tube 201 is finally completely enclosed inside the tube body 1, and the directional wire 202 is stably limited within the limiting hole 103, thus realizing the integrated assembly of the bent part 2 and the tube body 1.

[0056] After the tube body 1 and the reed tube 201 are assembled into an integrated structure, at least one axially extending mounting groove 102 is cut at the distal end of the tube body 1 using precision machining methods such as machining and laser cutting. The size and shape of the mounting groove 102 are adapted to the module body 301 of the visual module 3 to ensure that the visual module 3 can be stably installed. It should be noted that since the reed tube 201 and the tube body 1 have formed an integrated structure, and the reed tube 201 is made of nickel-titanium alloy, which has excellent shape memory function, the bending performance and structural stability of the reed tube 201 will not be affected during the machining of the mounting groove 102 at the distal end of the tube body 1.

[0057] Subsequent steps S200 and S300 are the same as in Example 1.

[0058] Example 3: like Figures 13 to 15 As shown, the difference between this embodiment and Embodiment 2 is that the tube body 1 is made of silicone material. The inner cavity of the silicone tube is slightly smaller than the outer diameter of the reed tube, such as 2.5 mm, and the wall thickness is 0.2 mm. First, the channel 101 of the tube body 1 is expanded by an expansion device so that the inner diameter of the tube body 1 is slightly larger than the outer diameter of the reed tube 201, such as 3 mm. Then, the tube body 1 is fitted onto the outside of the reed tube 201 and the directional wire 202. Utilizing the elastic recoil characteristics of the tube body 1 material itself, the tube body 1 tightly wraps around the reed tube 201 and the directional wire 202. Alternatively, silicone liquid coating or other coating processes can be used to assist in fixation. Since silicone itself has the special property of not sticking to metal, it can ensure that the directional wire 202 can move flexibly without affecting the bending adjustment of the bending part 2.

[0059] After the tube body 1 and the coiled spring tube 201 are assembled to form an integrated structure, the subsequent steps S200 and S300 are the same as in Example 2.

[0060] It should be further explained that in Embodiment 2, since the tube body 1 is provided with a limiting hole 103, the limiting hole 103 can reliably limit the directional wire 202. Therefore, the length of the coiled tube 201 can be less than the length of the tube body 1, and only needs to cover the far-end bending area of ​​the tube body 1, for example, 30-50mm. In Embodiment 3, the directional wire 202 is arranged between the tube body 1 and the coiled tube 201. The radial movement of the directional wire 202 is restricted by the inner wall of the tube body 1. Therefore, the length of the coiled tube 201 needs to be basically the same as the length of the tube body 1 (with an error of no more than 5%), for example, 700-800mm, to ensure that the directional wire 202 can be stably limited throughout its entire length.

[0061] In summary, the visual catheter and its manufacturing method provided in this application, by using a reed tube as the bending part and completely enclosing the reed tube within the tube body channel, eliminates the traditional process of connecting the snake bone structure to the tube body in endoscopes. This avoids the additional axial and radial space occupied by the connection, and achieves the reduction of the overall outer diameter of the visual catheter structure without changing the structural space, that is, the tube wall is made as thin as possible, leaving more channel space for the visual catheter channel and more channel space for supporting tools.

[0062] Meanwhile, by off-axis mounting the visual module in a mounting groove on the tube wall and ensuring that the projection of the visual module on the tube cross-section overlaps with the tube wall, a portion of the space between the visual module and the tube wall is shared. This significantly reduces the radial dimension occupied by the visual module, reserving more effective space for the internal channels of the tube. Compared to traditional multi-cavity structures, whose radial thickness is the sum of the thickness of the outer tube walls on both sides and the radial thickness of the internal multiple tubes, this application only requires the sum of the thickness of one side of the outer tube wall and the thickness of the two sides of the visual module wall. Moreover, the more complex the internal components and the more cavities, the more significant the advantage of this application in terms of space utilization becomes.

[0063] Traditional visual catheters employ a multi-tube structure, requiring cables to pass through multiple cavities. The overall cross-section is circular, and its radial thickness is the sum of the tube wall thickness and the thickness of multiple cables, resulting in a large space occupation. In contrast, this application designs the visual module as an off-axis structure, with a row of micro-cables attached to the inner or outer wall along the circumference of the tube. This reduces the radial thickness to only the sum of the tube wall thickness and the thickness of a single cable. Under the premise of the same outer diameter of the visual catheter, it can both reduce the radial dimension of the catheter end and significantly expand the space of the internal operating channel of the tube, effectively improving the space ratio and thus providing a larger passage for surgical instruments.

[0064] Based on this, larger instruments or stones can be allowed to pass through during procedures such as lithotripsy. For the same stone load, the time for lithotripsy and stone removal can be significantly shortened. This avoids the need to pulverize stones due to insufficient space, which would lead to increased energy output and damage. It also reduces water pressure in the surgical field and decreases reliance on auxiliary instruments such as sheaths, thereby alleviating patient pain and reducing the risk of invasive damage to the body's natural cavities. For example, while previous structures or combinations of structures could only accommodate stones as small as 1 mm, this invention can accommodate stones as small as 3 mm. For the same stone load, the new structure reduces the lithotripsy and stone removal time by more than 60%.

[0065] Furthermore, by setting directional wires spaced circumferentially along the reed tube, and combining this with limiting holes on the tube body or a structure where the directional wires are positioned between the reed tube and the inner wall of the tube, precise orientation of the curved portion is achieved. This also simplifies the structure and avoids the directional wires occupying additional space in the channel. The reed tube employs a variable pitch design, or the tube body adopts a variable flexibility design, allowing for better bending flexibility at the distal end of the insertion section and maintaining good pushing force and torsional control at the proximal end. This enables smooth pushing and precise operation in complex cavities, further improving surgical safety and operational efficiency.

[0066] In the description of this application, it should be noted that the terms "upper," "lower," etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application 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 application. Unless otherwise expressly specified and limited, the terms "installed," "connected," and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; 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 between two elements. For those skilled in the art, the specific meaning of the above terms in this application can be understood according to the specific circumstances.

[0067] It should be noted that in this application, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover 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 limitations, 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 the element.

[0068] The above are merely specific embodiments of this application, enabling those skilled in the art to understand or implement this application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of this application. Therefore, this application is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A visual catheter, characterized by, It includes: The tube (1) has a proximal end and a opposite distal end, and a channel (101) is formed in the tube (1) along the axial direction. At least one mounting groove (102) extending along the axial direction is recessed on the wall surface of the distal end of the tube (1). A visual module (3) is fixedly installed in the mounting groove (102), and its projection on the radial section of the tube body (1) overlaps with the wall surface of the tube body (1). The visual module includes: - The module body (301) includes a plurality of visual units and an encapsulation part (3013) that encapsulates the visual units. - A row of micro-cables (302) includes multiple cables (3021), which are attached to the wall of the tube (1) along the circumference and extend axially; each cable (3021) is electrically connected to each of the visual units in a one-to-one correspondence, and the cable (3021) is offset from the central axis of the module body (301).

2. The visual catheter as described in claim 1, characterized in that, The cross-sectional shape of the visual module (3) on the radial section of the conduit is L-shaped or T-shaped.

3. The visual catheter of claim 1, wherein, Also includes: The protective sleeve (4) is fitted over the outside of the tube body (1) and covers the head end of the visual module (3) inside the mounting groove (102).

4. The visual catheter as described in claim 1, characterized in that: The flexibility of the tube (1) varies along the tube axis, and the flexibility of the distal part is greater than that of the proximal part.

5. The visual catheter of claim 1, wherein, The distal end of the tube body (1) is provided with a bend (2), the bend (2) comprising: A reed tube (201) is fixed inside the tube body (1); At least two directional wires (202) are symmetrically arranged on the radial outer / inner side of the reed tube (201). The distal end of each directional wire (202) is fixedly connected to the reed tube (201), and the connection point is spaced apart from the distal end face of the reed tube (201) by a distance. The proximal end of each directional wire (202) extends toward the proximal end of the tube body (1).

6. The visual catheter as described in claim 5, characterized in that: The tube body (1) is provided with a plurality of limiting holes (103) in the circumferential direction. The number of limiting holes (103) is the same as the number of the directional wires (202) and their positions correspond. Each limiting hole (103) passes through the tube body (1) along the axial direction of the tube body (1), and the directional wires (202) are inserted into the corresponding limiting hole (103).

7. The visual catheter as described in claim 5, characterized in that: The reed tube (201) passes through the channel (101) along the axis of the tube body (1), and the directional wire (202) is located between the reed tube (201) and the inner wall of the tube body (1).

8. The visual catheter as described in claim 5, characterized in that: The reed tube (201) is disposed in the channel (101) and extends along the axial direction of the tube body (1); the pitch of the reed tube (201) varies along the axial direction, and the pitch at the distal end is greater than the pitch at the proximal end.

9. A method of making a visual catheter, comprising: Includes the following steps: Prepare a tube body (1) and provide at least one axially extending mounting groove (102) on the wall surface at the far end of the tube body (1). Prepare a visual module (3), place multiple visual units inside the encapsulation part (3013), and fill the area at the end of the visual unit connected to the cable (3021) and located inside the encapsulation part (3013) with a medium; The cable (3021) is pushed to one side of the inner wall of the encapsulation part (3013) by the squeezing action during the filling of the medium, so that the cable (3021) is arranged in sequence along the circumferential direction of the encapsulation part (3013), thereby deviating from the central axis of the module body (301) to form a row of micro cables (302). The visual module (3) is fixedly installed in the mounting groove (102), and the projection of the visual module (3) on the cross section of the tube (1) overlaps with the wall of the tube (1). The row-shaped micro cable (302) is attached to the wall of the tube (1) along the circumference of the tube (1).

10. The method of fabricating a visual catheter of claim 9, wherein, The preparation method of the tube body (1) includes: Prepare a reed tube (201) and fix at least two directional wires (202) at a distance from the distal end of the reed tube (201), the directional wires (202) being located on the radial outer / inner side of the reed tube (201); The reed tube (201) is fixedly connected to the tube body (1) in one of the following ways: Limiting holes (103) corresponding to the number and position of the directional wires (202) are opened on the wall of the tube (1). Each limiting hole (103) passes through the tube (1) along the axial direction of the tube (1). The directional wires (202) are inserted into the corresponding limiting holes (103). The tube (1) and the spring tube (201) are fused at the interface by the hot melt coating process. After the tube (1) is expanded, it is sleeved on the outer periphery of the spring tube (201) and the adjusting wire (202). The elastic restoring force of the tube (1) is used to form an interference fit, so that the two are fixedly connected. After the spring tube (201) is fixedly connected to the tube body (1), at least one axially extending mounting groove (102) is recessed on the wall surface at the far end of the tube body (1).

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