Anti-reflux ureteral stent
Patent Information
- Application Number
- CN202610806731.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-06-05
- Publication Date
- 2026-10-13
AI Technical Summary
[0004]本发明要解决的技术问题是提供一种防回流输尿管支架,以解决现有防回流输尿管支架多靠弹性瓣膜实现单向引流,但末端易弯折致瓣膜失效、密封不严,且易被结晶与碎屑堵塞,存在反流与堵管风险,难以满足临床长期安全使用的技术问题
[0016]上述方案中,通过在扩张头内部设置微型抗折球、硅胶座与微型杆形成一体化刚性支撑结构,可在植入过程、膀胱挤压、体位变换及长期留置状态下持续抵紧扩张头内壁,强制维持管腔呈圆形直通状态,从根本上避免传统输尿管支架末端易弯折、压扁、扭曲导致瓣膜错位失效的问题,确保封堵薄膜与柔性薄膜始终处于正确工作位置,显著提升防回流结构的稳定性与耐用性,即使在复杂生理环境下仍能保持连续可靠的单向导通功能,大幅降低因结构变形引发的反流失效风险,为长期留置患者提供更稳定的使用保障。
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Figure CN122894573A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical consumables, and in particular to an anti-reflux ureteral stent. Background Technology
[0002] A reflux-preventing ureteral stent is a sterile implantable medical consumable that allows urine to flow smoothly from the kidney to the bladder, but automatically closes the channel when bladder pressure increases during urination, preventing urine from flowing back into the kidney, thereby avoiding reflux-related back pain and infection.
[0003] In existing technologies, anti-reflux ureteral stents typically employ built-in elastic valves, with one to two silicone / TPU elastic valves (duckbill valves / flat tube valves) fixed within the bladder end of the stent lumen. The opening faces the bladder, and the closed end faces the ureter. However, because the ureter and the stent tip are made of flexible materials, the stent tip is prone to irregular bending, flattening, or twisting during implantation, bladder compression, changes in body position, or long-term indwelling. This directly leads to valve misalignment, opening deformation, or closure failure, resulting in the loss of anti-reflux function. On the other hand, the valves are mostly simple single-layer structures, which are easily affected by urine flushing, fatigue stress, and bladder pressure fluctuations over a long period of time, leading to elasticity decay and incomplete closure, still resulting in a small amount of urine reflux. Summary of the Invention
[0004] The technical problem to be solved by the present invention is to provide a ureteral stent that prevents backflow, in order to solve the technical problem that existing ureteral stents rely on elastic valves to achieve unidirectional drainage, but the ends are prone to bending, leading to valve failure and poor sealing, and are easily blocked by crystals and debris, posing risks of backflow and blockage, and making it difficult to meet the technical problem of long-term safe clinical use.
[0005] To solve the above-mentioned technical problems, the present invention provides the following technical solution: a ureteral stent for preventing backflow, comprising a ureteral stent, with dilators installed at both ends of the ureteral stent, side holes opened on the outer side of the dilators, a flexible membrane installed on the inner wall of the dilators, a deflecting ring sleeved on the inner side of the flexible membrane, a sealing membrane installed on the inner wall of the dilators, and a membrane tip installed at the bottom end of the sealing membrane.
[0006] Optionally, the diameter of the dilator head is larger than that of the ureteral stent, and the flexible membrane is configured as annular and its edges are connected to the inside of the dilator head.
[0007] Optionally, the sealing film is configured in multiple groups, the sealing film is configured as a double layer and the edges are nested with fine elastic fibers as a skeleton, and the surfaces of the flexible film and the sealing film are coated with a chitosan coating.
[0008] Optionally, each of the multiple sets of sealing films is connected to a fiber filament group on its back. The fiber filament group is composed of multiple fiber filaments, with one end of each fiber filament connected to the bottom end of the multiple sets of sealing films and the other end twisted into a single strand.
[0009] Optionally, a silicone disc is installed at one end of the fiber filament assembly, and the end of the fiber filament assembly twisted into a single strand is connected to the center of the silicone disc.
[0010] Optionally, a recessed hole is formed on one side of the inner wall of the silicone disc, and the edge of the silicone disc is shaped like a bowl.
[0011] Optionally, a guide fin is installed on the other side of the silicone disc, and multiple guide fins are provided, with the multiple guide fins being implanted alternately with the side holes.
[0012] Optionally, a miniature rod is inserted into the center of the silicone disc.
[0013] Optionally, a silicone seat is mounted on one end of the microrod.
[0014] Optionally, a miniature anti-bending ball is mounted on one side of the silicone seat.
[0015] Compared with the prior art, the present invention has at least the following beneficial effects:
[0016] In the above-mentioned scheme, by setting up a micro-anti-bending ball, silicone seat and micro-rod inside the dilator to form an integrated rigid support structure, it can continuously press against the inner wall of the dilator during the implantation process, bladder compression, body position changes and long-term indwelling state, forcibly maintaining the lumen in a circular straight state. This fundamentally avoids the problem of valve misalignment and failure caused by the easy bending, flattening and twisting of the end of the traditional ureteral stent. It ensures that the occlusive membrane and flexible membrane are always in the correct working position, significantly improves the stability and durability of the anti-reflux structure, and can maintain continuous and reliable unidirectional conduction function even in complex physiological environments. It greatly reduces the risk of reflux failure caused by structural deformation and provides more stable use guarantee for long-term indwelling patients.
[0017] By employing a dual anti-backflow sealing structure consisting of a flexible membrane and a sealing membrane, positive urine pressure can smoothly push open the membrane to achieve unobstructed drainage. When bladder pressure increases and reflux tends to occur, the reverse pressure drives the flexible membrane to change direction, forming the first barrier. At the same time, it guides the reflux to rush towards the sealing membrane, causing the sealing membrane to tightly close under the combined action of its own elastic fiber skeleton and reverse pressure. The membrane tips interlock to form a sealed sealing surface. The dual sealing significantly improves the anti-backflow sealing performance.
[0018] By incorporating a bowl-shaped structure and concave holes in the silicone disc, impurities such as epithelial debris, pus plugs, and mucus flocs in the urine can be effectively intercepted, preventing them from clogging the sealing membrane gaps or adhering to the valve surface and causing opening and closing malfunctions. At the same time, the guide fins and deflecting rings regulate and guide the urine flow, reducing turbulence and eddies and improving drainage smoothness. In addition, the flexible membrane and sealing membrane are coated with a chitosan coating, which can actively adsorb tiny impurities, inhibit the crystal deposition of calcium salts, oxalates, and urates, reduce biofilm formation, significantly reduce the probability of stent occlusion, and extend the safe indwelling period. It is especially suitable for clinical scenarios with stone predisposition, high risk of infection, and long-term catheterization, improving overall safety of use. Attached Figure Description
[0019] Figure 1 A three-dimensional schematic diagram of a ureteral stent;
[0020] Figure 2 This is a schematic diagram of the bladder dilator head structure;
[0021] Figure 3 This is a cross-sectional schematic diagram of the dilator head during forward urine flow from the bladder end;
[0022] Figure 4 This is a cross-sectional view of the dilator head from another perspective when urine is flowing forward from the bladder end;
[0023] Figure 5 A schematic diagram of the silicone disk and microrod structure;
[0024] Figure 6 This is a schematic diagram of the silicone pad and the recessed hole structure;
[0025] Figure 7 This is a schematic diagram of the structure of the bladder end dilator for preventing backflow.
[0026] Figure 8 This is a schematic cross-sectional view of the bladder dilator during backflow prevention.
[0027] Figure 9 This is a cross-sectional view from another perspective when the bladder dilator is used to prevent backflow.
[0028] Figure 10 This is a schematic diagram of the sealing membrane structure;
[0029] Figure 11 This is a schematic diagram of the sealing film and membrane tip structure.
[0030] Figure label:
[0031] 1. Ureteral stent; 2. Dilatator head; 3. Side hole; 4. Flexible membrane; 5. Directional ring; 6. Silicone seat; 7. Miniature anti-bending ball; 8. Miniature rod; 9. Silicone disc; 10. Concave hole; 11. Guide fin; 12. Fiber assembly; 13. Occlusive membrane; 14. Membrane tip. Detailed Implementation
[0032] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the following detailed description is provided in conjunction with the accompanying drawings and preferred embodiments, based on the specific implementation methods, structure, features, and effects of the present invention.
[0033] like Figures 1 to 11 As shown, an embodiment of the present invention provides an anti-reflux ureteral stent, including a ureteral stent 1. Dilatation heads 2 are installed at both ends of the ureteral stent 1. Side holes 3 are opened on the outer side of the dilatation heads 2. The dilatation heads 2, as key structures at both ends of the anti-reflux ureteral stent, have a diameter larger than the main body of the ureteral stent 1. This allows for stable radial expansion and positioning at the renal pelvis and bladder inlet, effectively preventing stent displacement, slippage, or retraction within the ureter, ensuring stable overall stent placement. The side holes 3 on the outer side increase the urine collection area, serving as the main channel for urine to enter the stent, preventing direct blockage of the stent opening by the ureteral mucosa, ensuring smooth drainage. Simultaneously, the smooth, expandable structure significantly reduces scratches, friction, and irritation to the ureteral mucosa during stent placement and indwelling, lowering the risk of mucosal damage, inflammation, bleeding, and hyperplasia. A flexible material is installed on the inner wall of the dilatation head 2. The flexible membrane 4 has a reversing ring 5 sleeved on its inner side. The inner wall of the dilator head 2 is fitted with a sealing membrane 13, and the bottom end of the sealing membrane 13 is fitted with a membrane tip 14. The diameter of the dilator head 2 is larger than that of the ureteral stent 1. The flexible membrane 4 is set as an annular shape and its edges are connected to the inner side of the dilator head 2. The sealing membrane 13 is set in multiple sets and is set as a double layer with fine elastic fiber filaments nested at the edges as a skeleton. Both the flexible membrane 4 and the sealing membrane 13 are coated with a chitosan coating. Under the limitation of the reversing ring 5, the flexible membrane 4 can only swing in the direction of urine flow, which ensures forward conduction and generates resistance when reverse flow changes direction. The double-layer sealing membrane 13, together with the elastic fiber filament skeleton, can improve the closure strength and rebound speed. The membrane tips 14 interlock to form a seal, which greatly improves the leakage prevention effect. The chitosan coating can adsorb debris, inhibit crystallization, and has antibacterial and biofilm-proof properties, which significantly reduces the risk of tube blockage and infection.
[0034] like Figure 5 , Figures 10 to 11 As shown, each of the multiple sealing membranes 13 has a fiber filament group 12 connected to its back. The fiber filament group 12 is composed of multiple fiber filaments. One end of each fiber filament is connected to the bottom of the multiple sealing membranes 13, and the other end is twisted into a single strand. The fiber filament group 12 adopts a transmission structure of multi-filament branching and single-strand concentration, which can evenly and synchronously transmit the thrust of the silicone disc 9 to each sealing membrane 13, ensuring that the multi-valve membranes unfold and close synchronously, avoiding single-valve jamming or asynchronous opening and closing that leads to sealing failure. The fiber filament material is soft and has high tensile strength, which does not affect the flexibility of the support. It is not easy to break or loosen after long-term use, ensuring stable and reliable opening and closing action.
[0035] like Figures 5 to 6 As shown, a silicone disc 9 is installed at one end of the fiber filament assembly 12, and the end of the fiber filament assembly 12 twisted into a single strand is connected to the center of the silicone disc 9. A concave hole 10 is provided on one side of the inner wall of the silicone disc 9. The bowl-shaped silicone disc 9 and the concave hole 10 form an impurity interception chamber, which can capture epithelial debris, pus plugs and mucus and discharge them with the urine flow, preventing the valve from being blocked.
[0036] The edge of the silicone disc 9 is bowl-shaped, and a guide fin 11 is installed on the other side of the silicone disc 9. Multiple guide fins 11 are installed, and multiple guide fins 11 are inserted into the side hole 3 in an alternating manner. The alternating arrangement of the guide fins 11 and the side hole 3 can straighten the urine flow, reduce turbulence, and improve drainage efficiency.
[0037] A micro rod 8 is inserted into the middle of the silicone disc 9. A silicone seat 6 is installed at one end of the micro rod 8. A micro anti-bending ball 7 is installed on one side of the silicone seat 6. The micro anti-bending ball 7, the silicone seat 6 and the micro rod 8 form an internal anti-bending support, which forcibly keeps the cavity of the expansion head 2 circular and straight, avoids the sealing structure from failing due to bending, and ensures the stability of the anti-backflow function throughout the process.
[0038] The working principle of the technical solution provided by this invention is as follows:
[0039] First, in the forward urination state, urine is allowed to flow smoothly from the kidneys to the bladder. The urine first enters the upper tube body without the sealing membrane 13 through the opening of the dilator 2 and the side hole 3 opened on the outer wall of the dilator 2.
[0040] When urine flows downwards in the forward direction, pressure is applied to the micro-anti-bending ball 7 on one side of the silicone seat 6. Because the dilator head 2 is made of flexible material, it may bend due to the pressure on the dilator head 2 during implantation, or due to the implantation location or pressure on the dilator head 2 inside the bladder, causing the posterior structure to fail to function. Due to the supporting effect of the micro-anti-bending ball 7 and the micro-rod 8, when there is bending, the micro-anti-bending ball 7 and the micro-rod 8 will press against the inner wall of the dilator head 2, keeping the dilator head 2 in a straight state at its location. The pressure of the urine flow pushes the silicone disc 9 downwards, and it will also continue to prevent excessive bending inside the bladder.
[0041] Driven by positive urine pressure and the anti-bending effect of the miniature anti-bending ball 7 and miniature rod 8, the silicone disc 9 is displaced by the flushing of urine. The silicone disc 9 drives the miniature rod 8, silicone seat 6 and miniature anti-bending ball 7 to move synchronously. The miniature rod 8 is fixed in the center of the silicone disc 9, and the silicone disc 9 drives the miniature rod 8 connected in the middle to move.
[0042] The silicone disc 9 is connected at the center to a fiber filament group 12, which consists of multiple fine filaments twisted into a single strand. When the silicone disc 9 moves, it simultaneously pushes the fiber filament group 12. The other end of the fiber filament group 12 is connected to the back of a sealing membrane 13 with a double-layer structure and elastic fiber filaments nested at the edges as a skeleton. Under the pushing force of the silicone disc 9 and the fiber filament group 12, the sealing membrane 13, which is sealed to each other, unfolds outward, opening multiple gaps. At the same time, the membrane tips 14 at the bottom of the membrane separate to form an open channel, allowing urine to pass through smoothly. The back of the silicone disc 9 is bowl-shaped with concave holes 10 on the inner wall. The concave holes 10 and the bowl-shaped design can block some debris and pus plugs, preventing the backflow of debris and pus plugs in normally flowing urine. If debris and pus plugs remain here, drinking more water regularly can carry them down with urine and prevent blockage.
[0043] Subsequently, when the urine passes through the annular flexible membrane 4 set on the inner wall of the dilator head 2, it changes direction to the right under the positive urine pressure with the deflection ring 5 sleeved on the inner side. The deflection ring 5 restricts the shape of the annular flexible membrane 4, but does not restrict the movement of the annular flexible membrane 4. When the annular flexible membrane 4 tilts to the right, it can prevent the urine from flowing out of the opening of the annular flexible membrane 4 and make the urine flow out smoothly. In conjunction with the guide fins 11 of the silicone disc 9 arranged in an alternating manner, the urine is regulated and guided, reducing turbulence and ensuring that the urine flows smoothly into the bladder.
[0044] When the pressure inside the bladder increases and urine reflux tends to occur, the reverse pressure acts directly on the annular flexible membrane 4. Under the reverse pressure of urine, the annular flexible membrane 4 changes direction to the left, forming resistance. The reverse urine pressure causes the flexible membrane 4 to adhere to the kidney side, while guiding the reflux towards the blocking membrane 13. The blocking membrane 13 has a slight elastic force and quickly contracts inward under the action of reverse pressure and its own stress. The bottom membrane tip 14 automatically rebounds under its own stress, tightly adhering to form a sealed blocking surface, blocking the reflux channel. Moreover, the diameter of the dilator head 2 is larger than that of the ureteral stent 1, which can stably position the stent at the junction of the ureter and the renal pelvis and bladder, avoiding displacement. The entire process realizes the function of forward unobstructed drainage and reverse automatic blocking to prevent reflux, thereby preventing urine from flowing back to the kidney and avoiding reflux back pain and infection.
[0045] In addition, the micro-anti-bending ball 7, silicone seat 6 and micro rod 8 inside the expansion head 2 form a rigid support, which can press against the inner wall of the expansion head 2 and keep the lumen straight, avoiding the failure of the sealing structure due to bending. The chitosan coating on the surface of the flexible film 4 and the sealing film 13 can adsorb debris and inhibit crystal deposition, reducing the risk of stent blockage, thereby achieving a stable anti-backflow effect of forward unobstructed drainage, reverse automatic sealing, bending resistance and anti-blockage.
[0046] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.
Claims
1. A ureteral stent for preventing backflow, characterized in that, The device includes a ureteral stent (1), with dilators (2) installed at both ends of the ureteral stent (1). A side hole (3) is provided on the outer side of the dilator (2). A flexible membrane (4) is installed on the inner wall of the dilator (2). A deflecting ring (5) is sleeved on the inner side of the flexible membrane (4). A sealing membrane (13) is installed on the inner wall of the dilator (2). A membrane tip (14) is installed at the bottom end of the sealing membrane (13).
2. The anti-reflux ureteral stent according to claim 1, characterized in that, The diameter of the dilator (2) is larger than that of the ureteral stent (1), and the flexible film (4) is arranged in a ring shape and its edges are connected around the inside of the dilator (2).
3. The anti-reflux ureteral stent according to claim 2, characterized in that, The sealing film (13) is configured in multiple groups. The sealing film (13) is configured as a double layer with fine elastic fiber filaments nested at the edges as a skeleton. The surfaces of the flexible film (4) and the sealing film (13) are coated with chitosan coating.
4. The anti-reflux ureteral stent according to claim 3, characterized in that, Each of the multiple sets of sealing films (13) has a fiber filament group (12) connected to its back. The fiber filament group (12) is composed of multiple fiber filaments. One end of each fiber filament is connected to the bottom end of the multiple sets of sealing films (13), and the other end is twisted into a strand.
5. The anti-reflux ureteral stent according to claim 4, characterized in that, A silicone disc (9) is installed at one end of the fiber filament group (12), and the end of the fiber filament group (12) twisted into a single strand is connected to the center of the silicone disc (9).
6. The anti-reflux ureteral stent according to claim 5, characterized in that, The silicone disk (9) has a recessed hole (10) on one side of its inner wall, and the edge of the silicone disk (9) is bowl-shaped.
7. The anti-reflux ureteral stent according to claim 6, characterized in that, A guide fin (11) is installed on the other side of the silicone disc (9). Multiple guide fins (11) are provided, and the multiple guide fins (11) are respectively implanted in an alternating manner with the side hole (3).
8. The anti-reflux ureteral stent according to claim 7, characterized in that, A micro rod (8) is inserted into the middle of the silicone disk (9).
9. The anti-reflux ureteral stent according to claim 8, characterized in that, A silicone seat (6) is installed at one end of the micro rod (8).
10. The anti-reflux ureteral stent according to claim 9, characterized in that: A miniature anti-bending ball (7) is installed on one side of the silicone seat (6).