A guiding structure, a ureteral sheath and a ureteral insertion device

Abstract

The present invention discloses a guide structure, a ureteral sheath, and a ureteral insertion device, which relate to the technical field of medical devices. The guide structure of the invention comprises an outer tube body, an inner tube body, and a spiral tube. The inner tube body is arranged on the inner wall of the outer tube body, a guide channel is axially provided in the inner tube body, and the spiral tube is spirally wound between the outer tube body and the inner tube body along the axial direction; the invention also comprises a reinforcement wire body, which passes in and out of the gap between at least part of the spiral segment along the axial direction of the outer tube body, and at least part of the inner penetration section of the reinforcement wire body located on the inner side of the spiral tube is fixedly penetrated into the inner tube body. Compared with the existing technology, the present invention can effectively prevent the inner tube body from bulging, allowing the instrument to be inserted more smoothly into the guide channel.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a guiding structure, a ureteral sheath and a ureteral insertion device. Background Art

[0002] A ureteral sheath is a medical device widely used in urological surgeries. It typically consists of an outer tube, an intermediate coiled tube (also known as a spring tube), and an inner tube. The device is designed to provide support and create a pathway for endoscopes and other instruments to enter the urinary tract, allowing for smooth insertion of a catheter into the ureter.

[0003] After long-term practice, the inventors found that during the operation, the inner tube of the ureteral sheath often bulges, which affects the smoothness of the instrument insertion. Summary of the Invention

[0004] The present invention discloses a guiding structure, a ureteral sheath and a ureteral insertion device, so as to solve the technical problem of the ureteral sheath in the related art affecting the smoothness of instrument insertion.

[0005] In order to solve the above problems, the present invention adopts the following technical solutions:

[0006] In the first aspect, the present invention provides a guide structure for a ureteral sheath, comprising an outer tube body, an inner tube body and a spiral tube, wherein the inner tube body is arranged on the inner wall of the outer tube body, a guide channel is axially provided in the inner tube body, and the spiral tube is spirally wound between the outer tube body and the inner tube body along the axial direction; and further comprising a reinforcement wire body, which passes in and out of the gap of at least part of the spiral segment along the axial direction of the outer tube body, and at least part of the inner penetration section of the reinforcement wire body located on the inner side of the spiral tube is fixedly penetrated into the inner tube body.

[0007] Preferably, the outer tube body or the inner tube body has a filling portion, and the filling portion is embedded in the gap between adjacent spiral segments of the spiral tube.

[0008] Preferably, when the filling portion of the inner tube body is embedded in the gap between adjacent spiral segments, at least a portion of the outer penetration segment of the reinforcement wire body located outside the spiral tube is fixedly penetrated into the outer tube body.

[0009] Preferably, when the filling portion of the outer tube body is embedded in the gap between adjacent spiral segments, the inner tube wall surface of the outer tube body is concave to form a groove to accommodate the spiral segments and the reinforcement wire body, and one side of the reinforcement wire body is in contact with the inner wall of the groove and the other side is in contact with the spiral segment.

[0010] Preferably, the filling portion and the adjacent helical segments are connected by bonding with a biocompatible adhesive or by thermal fusion.

[0011] Preferably, the corner portion of the reinforcement wire body is in contact with the spiral tube.

[0012] Preferably, both ends of the reinforcing wire are provided with limiting sub-segments. After the reinforcing wire passes through the gap in and out of at least part of the spiral segment, the limiting sub-segment overlaps with the spiral segment at the outermost end of the spiral tube to limit the radial position of the spiral segment.

[0013] Preferably, the limiting sub-segment is vertically bent from below or above the outermost spiral segment on the spiral tube to the side of the corresponding spiral segment, and then bent in the opposite direction and overlapped with the upper end or lower end of the corresponding spiral segment.

[0014] In a second aspect, the present invention provides a ureteral sheath comprising the guiding structure described in any of the above schemes.

[0015] In a third aspect, the present invention provides a ureteral insertion device comprising the above-mentioned guiding structure or the above-mentioned ureteral sheath.

[0016] The technical solution adopted by the present invention can achieve the following beneficial effects:

[0017] 1. By adding reinforcing wires, filling parts and limiting sub-segments to the guide structure, the stability of the inner and outer tubes of the ureteral sheath can be significantly improved, and the separation or bulging between the inner and outer tubes can be prevented. The traction effect of the reinforcing wires and the radial position limitation of the limiting sub-segments effectively prevent the connection surface between the spiral tube and the inner and outer tubes from peeling off due to uneven force or changes in the pitch of the spiral tubes during use. The combination of the reinforcing wires and the spiral segments and the supporting effect of the filling parts ensure that even if the inner and outer tubes are partially peeled off, the structural integrity can be maintained, avoiding the separation from further expanding into bulging, thereby improving the reliability and service life of the product; in this way, when inserting instruments into the guide cavity, it can also be smoother because there is no bulging;

[0018] 2. The design of the filling part enables precise control of the gaps between adjacent segments of the spiral tube, effectively preventing the pitch of the spiral tube from changing due to forward and backward movement during use. By fitting the filling part into the gaps between the spiral segments, the stability of the spiral tube in the axial and radial directions can be ensured, avoiding uneven connections between the inner and outer tubes and loose structures due to pitch changes. This design effectively suppresses the shear force caused by pitch changes, thereby avoiding the potential risks of delamination and uneven connection of the inner and outer tubes. In this way, the service life of the ureteral guide sheath can be extended and its reliability in medical surgery can be improved;

[0019] 3. In the design of the reinforcement wire and the spiral tube structure, especially considering the difference in thermal expansion coefficients, by adding a close fit between the inner and outer tubes and the reinforcement wire in the structure, the peeling or bulging of the inner and outer tubes caused by different thermal expansion can be reduced when the temperature changes. The difference in thermal expansion coefficients of the metal and glue interface of the spiral tube and the cladding body is effectively controlled. The design ensures that even under long-term use or large temperature fluctuations, the guide structure can still maintain its stability and prevent deformation, peeling or bulging caused by inconsistent thermal expansion. The traction effect of the reinforcement wire and the mechanical locking between the structures ensure the stability and safety of the inner and outer tubes in various environments, thereby improving the application effect of the guide structure in clinical practice. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0021] Figure 1 This is a schematic diagram of a partial structure of the guide structure of an embodiment of the present application;

[0022] Figure 2 This is a partial cross-sectional view showing the interior of the guide structure according to an embodiment of the present application;

[0023] Figure 3 This is a partial cross-sectional view of the embodiment of the present application for showing the inner layer distribution of the guide structure. Figure 1 ;

[0024] Figure 4 yes Figure 3 A front cross-sectional view showing the inner layer distribution of the guide structure;

[0025] Figure 5 This is a partial cross-sectional view of the embodiment of the present application for showing the inner layer distribution of the guide structure. Figure 2 ;

[0026] Figure 6 yes Figure 5 A front cross-sectional view showing the inner layer distribution of the guide structure;

[0027] Figure 7 This is a front cross-sectional view of an embodiment of the present application, used to illustrate the contact between the corner portion of the reinforcement wire and the spiral tube;

[0028] Figure 8 This is a partial cross-sectional view of the embodiment of the present application for showing the inner layer distribution of the guide structure. Figure 3 ;

[0029] Figure 9 yes Figure 8 Enlarged view of part A in .

[0030] In the picture:

[0031] 100. Outer tube body; 110. Second embedded channel; 120. Groove; 200. Inner tube body; 210. Guide channel; 220. First embedded channel; 300. Helical tube; 310. Helical segment; 400. Reinforcement wire body; 410. Limiting sub-segment; 500. Filling part. DETAILED DESCRIPTION

[0032] To make the objectives, technical solutions, and advantages of the present invention more apparent, the technical solutions of the present invention will be described in detail below. Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other implementations obtained by those of ordinary skill in the art without inventive effort are within the scope of protection of the present invention.

[0033] The terms "first," "second," and the like in the specification and claims of this application are used to distinguish similar objects, and are not used to describe a specific order or precedence. It should be understood that the terms used in this manner are interchangeable where appropriate, so that the embodiments of this application can be implemented in an order other than that illustrated or described herein, and that the objects distinguished by "first," "second," and the like are generally of the same type, and do not limit the number of objects; for example, the first object can be one or more. In addition, the term "and / or" in the specification and claims refers to at least one of the connected objects, and the character " / " generally indicates that the objects connected are in an "or" relationship.

[0034] In the related art, the ureteral introducer sheath is a medical device widely used in urological surgeries. It is usually composed of an outer tube, an intermediate layer of spiral tube (also known as a spring tube), and an inner tube. The design of this device is to provide a certain amount of support to enable the catheter to be smoothly introduced into the ureter. However, in practice, the inner layer often bulges, especially after long-term use, when the delamination and detachment between the inner and outer tubes become more prominent. After in-depth research, the applicant found that the root cause of the inner tube bulging phenomenon is the delamination and detachment between the outer and inner tubes, which in turn stems from multiple structural defects in the existing design.

[0035] First, the interface between the inner and outer tubes of the ureteral guide sheath is not smooth and continuous. Instead, due to the structural characteristics of the spiral tube in the middle layer, an uneven contact surface is formed. Specifically, the metal-glue interface of the spiral tube exhibits a periodic change pattern, which leads to significant differences in the strength and area of the bonding area. Due to this periodic change, the bonding force of the inner and outer tubes is uneven in different areas, especially when bent or stressed, and it is easy to start to separate from the weak connection points. This separation gradually expands from a small area, eventually causing bulging of the inner tube. Therefore, the structural characteristics of the spiral tube and the periodic changes in the metal-glue interface are the main factors leading to the delamination and separation of the inner and outer tubes.

[0036] Secondly, the spiral tube, which serves as the wire material of the middle layer, has the problem of forward and backward displacement during use. This displacement causes the pitch of the spiral tube to change, which in turn makes the connection quality between the inner and outer tubes unbalanced. The change in pitch not only affects the stability of the connection between the inner and outer tubes, but also applies shear force to the connection surface during the change process. The action of shear force will aggravate the peeling between the inner and outer tubes, thereby further aggravating the occurrence of bulging of the inner tube. Even in the absence of obvious external force, the pitch change itself can cause a slight detachment between the inner and outer tubes, and gradually worsen with the extension of use time, ultimately affecting the overall performance of the ureteral guide sheath.

[0037] Existing technologies fail to effectively address the uneven coupling and pitch variations caused by the spiral tube structure, leading to frequent bulging of the inner tube and delamination of the inner and outer tubes during use. This not only affects the reliability and stability of ureteral guide sheaths during clinical surgery but can also adversely affect the patient's treatment process. Therefore, a new structural design is urgently needed that can effectively prevent or mitigate the delamination of the inner and outer tubes and improve the smoothness of ureteral guide sheath insertion.

[0038] Based on this, the present application provides a guiding structure, a ureteral sheath and a ureteral insertion device.

[0039] The following is combined with Figures 1 to 9 , a guide structure, ureteral sheath and ureteral insertion device provided by the present application are described in detail through specific embodiments and their application scenarios.

[0040] First, combining Figure 1 、 Figure 2The present application provides a guide structure for use in a ureteral sheath, comprising an outer tube body 100, an inner tube body 200, and a spiral tube 300. The inner tube body 200 is disposed on the inner wall of the outer tube body 100, and a guide channel 210 is axially defined within the inner tube body 200. The spiral tube 300 is spirally wound along the axial direction between the outer tube body 100 and the inner tube body 200. For example, during the initial production of the guide structure, the spiral tube 300 is first sleeved onto the inner tube body 200, and then the outer tube body 100 is formed around the outer periphery of the inner tube body 200 through an extrusion injection molding process. In this way, the spiral tube 300 is wrapped between the inner tube body 200 and the outer tube body 100. Furthermore, during surgery, the guide structure is directly inserted into the patient's ureter, and the guide channel 210 allows surgical instruments to enter the ureter and reach the lesion.

[0041] At the same time, combined Figure 3 、 Figure 4 The guide structure further includes a reinforcing wire 400 that passes through at least a portion of the gaps between the helical segments 310 along the axis of the outer tube 100. At least a portion of the inner section of the reinforcing wire 400 located inside the helical tube 300 is fixedly disposed within the inner tube 200. For example, the reinforcing wire 400 may pass through the gaps between the plurality of helical segments 310 sequentially, or may pass through the gaps between the helical segments 310 at intervals. Furthermore, when there is a reinforcement wire 400 in the guide structure, when the guide structure is initially manufactured, the reinforcement wire 400 is first passed in and out of the gap between multiple spiral segments 310, and then the inner tube body 200 is injection-molded inside the spiral tube 300 with the reinforcement wire 400 through the extrusion injection molding process, and then the outer tube body 100 is bonded to the outer surface of the spiral tube 300. In this way, the spiral tube 300 and the reinforcement wire 400 can be wrapped between the inner tube body 200 and the outer tube body 100. At the same time, under the extrusion injection molding manufacturing process, in the injection-molded inner tube body 200, part of the inner tube body 200 can surround the reinforcement wire 400, so that the reinforcement wire 400 forms an anchor point with it.

[0042] For example, when the reinforcement wire 400 is shuttled in and out into the gap of the spiral segment 310 of the spiral tube 300, the reinforcement wire 400 can be bent into a corrugated shape in advance according to a preset shape, and then one end of the reinforcement wire 400 is fixed, and the other end of the reinforcement wire 400 is first inserted into the gap at the end of the spiral segment 310, and then the spiral tube 300 is rotated around the central axis of the spiral tube 300. At this time, the reinforcement wire 400 can automatically and gradually penetrate into the entire section of the spiral tube 300.

[0043] For example, a first embedded channel 220 is provided within the wall of the inner tube 200 for the reinforcement wire 400 to pass through, allowing the reinforcement wire 400 to avoid the spiral segment 310 of the spiral tube 300, while forming an anchoring point between the reinforcement wire 400 and the first embedded channel 220. It is worth noting that the first embedded channel 220 is a circumferentially closed channel with two open ends, rather than a slot structure. In other words, after the reinforcement wire 400 passes through the first embedded channel 220, the segment of the reinforcement wire 400 located within the first embedded channel 220 and the spiral segment 310 are in a mutually avoiding state.

[0044] On this basis, the pulling action of the reinforcement wire 400 effectively prevents delamination and detachment between the inner tube body 200 and the outer tube body 100. Even if the connection surface between the outer tube body 100 and the inner tube body 200 separates due to force during use, the designed reinforcement wire 400 limits the relative movement of the inner and outer tube bodies through a fixed inner penetration section, preventing further axial expansion of the detached area. At the same time, the presence of the reinforcement wire 400 strengthens the connection between the inner tube body 200 and the outer tube body 100, making it difficult for the delamination between the inner tube body 200 and the outer tube body 100 to expand into a bulge even under stress, significantly improving the stability and structural integrity of the ureteral sheath. In particular, when the connection surface between the outer tube body 100 and the inner tube body 200 is relatively weak or uneven, the reinforcement wire 400 acts as a local reinforcement, ensuring the reliability of the guide structure during use. Furthermore, the function of the reinforcement wire 400 is not limited to preventing detachment, it can also effectively limit the change in the pitch of the spiral tube 300. Since the reinforcement wire 400 shuttles in and out of the gap between the spiral segments 310, it will limit the pitch between two adjacent spiral segments 310, reducing the impact of the shear force caused by the pitch change on the joint surface of the inner and outer tubes, thereby further optimizing the performance of the guide structure.

[0045] In summary, the reinforcement wire 400 plays a vital role in the guide structure of the present application. It can effectively solve the bulging problem caused by the delamination of the inner tube body 200 and the outer tube body 100, and ensure the stability and long-term reliability of the ureteral sheath during use.

[0046] For example, inner tube 200 can be made of materials such as polyethylene and PTFE, serving as the inner layer that contacts the medical fluid. Outer tube 100 can be made of materials such as polyurethane and PEBAX. Furthermore, the thermal expansion coefficient of the material of spiral tube 300 is less than that of inner tube 200 and less than that of outer tube 100.

[0047] Polyethylene and polytetrafluoroethylene are common biocompatible materials with excellent chemical and corrosion resistance, effectively resisting various chemicals and pharmaceutical components in medical fluids. This allows the inner tube 200 to maintain stable physical and chemical properties over time when in contact with biological fluids such as urine, making it less susceptible to deformation or degradation, ensuring safety and hygiene during patient use.

[0048] Furthermore, polyethylene and PTFE materials have a low coefficient of friction, significantly reducing resistance during instrument insertion, making the guide sheath insertion smoother and reducing trauma and discomfort to the patient. Polyurethane and PEBAX, the materials used for the outer tube 100, not only possess high mechanical strength and toughness, effectively providing the necessary support, but also exhibit excellent elasticity, capable of withstanding certain bending and stretching without breakage, thereby enhancing the durability and reliability of the entire guide structure.

[0049] In general, the use of materials such as polyethylene, PTFE, polyurethane and PEBAX enables the inner tube body 200 and the outer tube body 100 to have good biocompatibility, durability, flexibility and chemical resistance, which can greatly improve the performance of the ureteral sheath and ensure its safety, stability and effectiveness in clinical surgery.

[0050] In some embodiments, combined Figure 4 、 Figure 6 The outer tube body 100 or the inner tube body 200 has a filling portion 500 , which is embedded in the gap between adjacent spiral segments 310 of the spiral tube 300 . Exemplarily, the material of the filling portion 500 corresponds to the material of the outer tube body 100 or the inner tube body 200 .

[0051] Specifically, during use, the pitch between adjacent helical segments 310 of the helical tube 300 often varies due to material variability and the stresses applied to the structure. This can be particularly true when subjected to external forces or prolonged use, which can easily lead to pitch deviations in the helical tube 300, thereby impacting the stability and reliability of the entire guide structure. The filling portion 500, by fitting into the gaps between adjacent helical segments 310, stabilizes the pitch of the helical tube 300, effectively preventing such pitch variations.

[0052] Furthermore, the filling portion 500, by physically embedding itself in the gaps between the segments of the spiral tube 300, limits the relative displacement of the segments of the spiral tube 300, thereby maintaining the pitch of the spiral tube 300 within a relatively fixed range. This not only improves the stability of the spiral tube 300, but also avoids the adverse effects of pitch variations, particularly the problems that may arise from uneven stress and unstable connection between the inner and outer tube bodies due to pitch variations in the spiral tube 300. The presence of the filling portion 500 makes the pitch of the spiral tube 300 less susceptible to change, thereby reducing the impact of the shear force generated by pitch variations on the interface between the inner and outer tube bodies, further enhancing the connection strength and stability of the inner and outer tube bodies.

[0053] Furthermore, the design of the filling portion 500 reduces slippage or friction between the spiral tube 300 and the inner and outer tube bodies, thereby effectively improving the mechanical strength of the entire guide structure and reducing the risk of failure due to material fatigue. Overall, the use of the filling portion 500 effectively ensures the consistency of the pitch of the spiral tube 300, thereby improving the overall performance of the guide structure and making it more reliable and durable in actual use.

[0054] In some embodiments, Figure 2 、 Figure 3 as well as Figure 4 As shown, when the filling portion 500 of the inner tube 200 is embedded in the gap between adjacent spiral segments 310 , at least a portion of the outer penetration section of the reinforcement wire 400 located outside the spiral tube 300 is fixedly penetrated into the outer tube 100 .

[0055] Exemplarily, a second embedded channel 110 is provided in the tube wall of the outer tube body 100 for the reinforcement wire body 400 to pass through, so that after the reinforcement wire body 400 passes through the first embedded channel 220, the filling part 500 and the second embedded channel 110 in sequence, it continues to avoid the spiral segment 310 of the spiral tube 300, and an anchor point is also formed between the reinforcement wire body 400 and the second embedded channel 110.

[0056] On this basis, the design of the first embedded channel 220 and the second embedded channel 110 enables the reinforcement wire 400 to pass through the inner and outer tube bodies firmly and form an anchor point in the outer tube body 100, further strengthening the bonding force between the inner and outer tube bodies. This structure not only effectively limits the relative displacement between the inner and outer tube bodies, avoiding detachment and bulging caused by external forces or long-term use, but also enhances the stability of the spiral tube 300 and reduces the shear force caused by pitch changes. Through the action of the reinforcement wire 400, even if there is a partial detachment at the junction of the inner and outer tube bodies, relying on the anchor point between the reinforcement wire 400 and the second embedded channel 110, it can effectively prevent the detachment area from further expanding, ensuring the reliability of the guide structure during long-term use.

[0057] In addition, the combination of the reinforcement wire 400 and the filling portion 500 can provide additional support within the gaps between the segments of the spiral tube 300, making the spiral tube 300 more stable during stress and less prone to displacement or deformation. The design of the reinforcement wire 400 improves the compression and tensile strength of the overall structure, enhances the mechanical strength of the guide structure, and further improves the overall performance and service life of the ureteral sheath. In summary, through the coordination of the first embedded channel 220, the filling portion 500, and the second embedded channel 110, and the anchor point formed by the reinforcement wire 400, the guide structure significantly improves the connection stability between the inner and outer tube bodies, prevents detachment and bulging, and ensures the safety and stability of the medical device during use.

[0058] In some embodiments, Figure 5 as well as Figure 6 As shown, when the filling portion 500 of the outer tube body 100 is embedded in the gap between adjacent spiral segments 310, the inner tube wall surface of the outer tube body 100 is concave to form a groove 120 for accommodating the spiral segments 310 and the reinforcement wire body 400, and one side of the reinforcement wire body 400 is in contact with the inner wall of the groove 120, and the other side is in contact with the spiral segment 310.

[0059] On this basis, one side of the reinforcing wire 400 is in contact with the inner wall of the groove 120, ensuring the positioning stability of the reinforcing wire 400 within the outer tube 100 and preventing the reinforcing wire 400 from being displaced by external forces. On the other hand, the other side of the reinforcing wire 400 is in contact with the spiral segment 310, enhancing the synergy between the reinforcing wire 400 and the spiral tube 300 and effectively limiting the relative displacement between the segments of the spiral tube 300. Through this design, the reinforcing wire 400 not only effectively improves the connection stability between the outer tube 100 and the inner tube 200, but also prevents the pitch of the spiral tube 300 from changing or the outer tube 100 from detaching during long-term use. At the same time, the presence of the groove 120 reduces the friction between the reinforcing wire 400 and the outer tube 100, making the movement of the reinforcing wire 400 smoother and less susceptible to squeezing or twisting, thereby extending the service life of the guide structure and improving the overall reliability of the ureteral sheath. In addition, the optimization of the guide structure can effectively avoid the instability factors caused by the friction between the spiral tube 300 and the reinforcement wire 400, further improving the overall performance of the guide structure.

[0060] It is worth noting that when the main structure of the filling portion 500 is the outer tube 100 , the second embedding channel 110 in the outer tube 100 can be eliminated and replaced by the groove 120 on the surface of the outer tube 100 .

[0061] In some embodiments, the filling portion 500 and the adjacent helical segments 310 are bonded or thermally fused using a biocompatible adhesive. Optionally, the contact surface between the inner tube 200 and the outer tube 100 is also coated with a biocompatible adhesive to increase the strength of the bond. Examples of biocompatible adhesives include polyurethane adhesives, polyvinyl alcohol (PVA) adhesives, acrylic adhesives, and hyaluronic acid (HA)-based adhesives. Polyurethane (PU) adhesives are widely used in medical devices and exhibit excellent biocompatibility, elasticity, and water resistance, making them suitable for use in environments involving direct human contact. PVA is a water-soluble polymer with good biocompatibility, commonly used in surgical procedures, and exhibits a certain degree of biodegradability. Acrylic acid and its derivatives, such as methacrylic acid (MMA), are frequently used in medical devices. They are generally harmless to the human body and effectively form strong bonds. Hyaluronic acid is a naturally occurring polysaccharide found in human tissue and is commonly used in surgical procedures. Hyaluronic acid-based adhesives exhibit excellent biocompatibility and lubricity.

[0062] In some embodiments, Figure 7 As shown, the corners of the reinforcing wire 400 are in contact with the spiral tube 300. Furthermore, the corners of the reinforcing wire 400 are in contact with the surface of the spiral segment 310, which can limit the movement of the spiral tube 300 to a certain extent, ensuring that the pitch of two adjacent spiral segments 310 is not easily changed. In addition, when the guide structure is inserted into the ureter, the inner tube body 200 is less likely to bulge when it is bent.

[0063] In some embodiments, combined Figure 8 、 Figure 9 , both ends of the reinforcing wire body 400 are provided with a limiting sub-segment 410. After the reinforcing wire body 400 passes through the gap in and out of at least part of the spiral segment 310, the limiting sub-segment 410 overlaps with the spiral segment 310 at the outermost end of the spiral tube 300 to limit the radial position of the spiral segment 310.

[0064] Illustratively, the limiting sub-segment 410 is vertically bent from below the outermost spiral segment 310 on the spiral tube 300 to the side of the corresponding spiral segment 310 , and then bent in the opposite direction and overlapped with the upper end of the corresponding spiral segment 310 .

[0065] Illustratively, the limiting sub-segment 410 is vertically bent from above the outermost spiral segment 310 on the spiral tube 300 to the side of the corresponding spiral segment 310 , and then bent in the opposite direction and overlapped with the lower end of the corresponding spiral segment 310 .

[0066] On this basis, the presence of the limiting sub-segment 410 can effectively prevent the spiral segment 310 from being displaced or loosened during use. The reinforcing wire 400, by overlapping with the spiral segment 310, limits the free radial movement of the spiral segment 310, avoiding the segments of the spiral tube 300 from being offset due to external forces, especially under the bending and pressure applied to the guide structure during operation, thereby improving the mechanical stability of the entire guide structure. This design can effectively reduce the gap changes between the spiral segments 310, thereby effectively improving the connection quality of the inner and outer tube bodies, and avoiding problems such as interlayer detachment and bulging caused by the instability of the spiral segment 310 in traditional designs.

[0067] At the same time, by bending vertically to the side below or above the spiral segment 310 and then bending back, the limiting sub-segment 410 not only strengthens its grip on the spiral segment 310 but also achieves more effective mechanical locking in space, further enhancing the fixation of the spiral segment 310. This design effectively prevents radial offset or displacement of the spiral segment 310 due to external forces or long-term use, thereby increasing the long-term stability and reliability of the guide structure.

[0068] In a second aspect, the present application provides a ureteral sheath comprising the guide structure of any of the above embodiments.

[0069] In a third aspect, the present application further provides a ureteral insertion device, comprising the guiding structure of the first aspect or the ureteral sheath of the second aspect.

[0070] It should be noted that, in this document, the terms "comprises," "includes," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or apparatus comprising a series of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or apparatus comprising the element.

[0071] Furthermore, it should be noted that the scope of the methods and apparatuses in the embodiments of the present application is not limited to performing functions in the order shown or discussed, but may also include performing functions substantially simultaneously or in reverse order depending on the functions involved. For example, the methods described may be performed in an order different from that described, and various steps may be added, omitted, or combined. Furthermore, features described with reference to certain examples may be combined in other examples.

[0072] The above description is only a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any technician familiar with this technical field can easily think of changes or replacements within the technical scope disclosed by the present invention, which should be covered by the scope of protection of the present invention.

Claims

1. A guide structure for a ureteral sheath, characterized in that: The invention comprises an outer tube body (100), an inner tube body (200), and a spiral tube (300), wherein the inner tube body (200) is arranged on the inner wall of the outer tube body (100), a guide channel (210) is axially provided in the inner tube body (200), and the spiral tube (300) is spirally wound between the outer tube body (100) and the inner tube body (200) along the axial direction; The invention also includes a reinforcing wire body (400), which is inserted into and out of the gap of at least a portion of the spiral segment (310) along the axial direction of the outer tube body (100), and at least a portion of the inner-penetrating segment of the reinforcing wire body (400) located on the inner side of the spiral tube (300) is fixedly inserted into the inner tube body (200) and surrounded by the inner tube body (200) to form an anchor point with the inner tube body (200).

2. The guide structure according to claim 1, characterized in that: The outer tube body (100) or the inner tube body (200) has a filling portion (500), and the filling portion (500) is embedded in the gap between adjacent spiral segments (310) of the spiral tube (300).

3. The guide structure according to claim 2, characterized in that: When the filling portion (500) of the inner tube body (200) is embedded in the gap between adjacent spiral segments (310), at least a portion of the outer penetration section of the reinforcement wire body (400) located outside the spiral tube (300) is fixedly penetrated into the outer tube body (100).

4. The guide structure according to claim 2, characterized in that: When the filling portion (500) of the outer tube body (100) is embedded in the gap between adjacent spiral segments (310), the inner tube wall surface of the outer tube body (100) is concave to form a groove (120) for accommodating the spiral segments (310) and the reinforcement wire body (400), and one side of the reinforcement wire body (400) is in contact with the inner wall of the groove (120), and the other side is in contact with the spiral segment (310).

5. The guide structure according to any one of claims 2 to 4, characterized in that: The filling portion (500) is connected to the adjacent spiral segment (310) by bonding with a biocompatible adhesive or thermal fusion.

6. The guide structure according to claim 1, characterized in that: The corner portion of the reinforcing wire body (400) is in contact with the spiral tube (300).

7. The guide structure according to claim 1, characterized in that: Both ends of the reinforcing wire (400) are provided with limiting sub-segments (410). After the reinforcing wire (400) passes through the gap in and out of at least part of the spiral segment (310), the limiting sub-segment (410) overlaps with the spiral segment (310) at the outermost end of the spiral tube (300) to limit the radial position of the spiral segment (310).

8. The guide structure according to claim 7, characterized in that: The limiting sub-segment (410) is vertically bent from below or above the outermost spiral segment (310) on the spiral tube (300) to the side of the corresponding spiral segment (310), and then bent in the opposite direction and overlapped with the upper end or lower end of the corresponding spiral segment (310).

9. A ureteral sheath, characterized in that: The invention comprises the guiding structure according to any one of claims 1 to 8.

10. A ureteral insertion device, characterized in that: It comprises the guiding structure according to any one of claims 1 to 8 or the ureteral sheath according to claim 9.

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