Anti-reflux ureteral stent

By setting a flap-like structure on the side wall of the ureteral stent, the problem of urine reflux when the bladder pressure is increased is solved, and the significant anti-reflux effect is achieved, the patient's use comfort is improved, and the functional performance of the stent is improved without increasing costs and changing operating habits.

WO2025107902A1PCT designated stage expired Publication Date: 2025-05-30NANCHANG CHENGXI TECHNOLOGY EQUIPMENT CO LTD
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Patent Information

Application Number
PCT/CN2024/123296
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-11-23
Filing Date
2024-10-08
Publication Date
2025-05-30

AI Technical Summary

Technical Problem

The existing ureteral stent is prone to urine reflux when the bladder pressure is increased, resulting in discomfort in the patient. Since the stent is relatively small, it is difficult to set up an anti-reflux structure. The existing solutions cannot achieve significant anti-reflux effect while maintaining the stent function.

Method used

By providing a flap-like structure on the side wall of the ureteral stent, the flap-like structure opens and closes the lumen when the pressure changes, and the anti-reflux function is achieved. This solution does not change the morphology of the stent and does not affect the guidewire passage and drainage ability.

Benefits of technology

It effectively prevents urine reflux, improves the patient's comfort, and achieves significant anti-reflux effect, which can improve the functional performance of the stent without increasing costs, side reactions and changing operating habits.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention provides an anti-reflux ureteral stent. A leaflet-shaped structure is arranged on a side wall of the stent at a bladder end to achieve a one-way drainage function, and the leaflet-shaped structure defines a lumen of the stent in a cross-section along with a tube wall of the stent. The outer surface of the leaflet-shaped structure is larger than the inner surface thereof. When the external pressure of the leaflet-shaped structure is larger than the internal pressure of the leaflet-shaped structure, the leaflet-shaped structure is attached to the tube wall, and the tube wall supports the leaflet-shaped structure, thereby sealing the lumen. The present invention can achieve, by means of the leaflet-shaped structure, one-way drainage in the ureteral stent, so as to effectively achieve an anti-reflux effect.
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Description

Anti-reflux ureteral stent Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an anti-reflux ureteral stent. Background Art

[0002] The ureter is a tubular organ that connects the kidney to the bladder, transporting urine from the kidney to the bladder. A ureteral stent is a support structure placed within the ureter. It is primarily tubular, but also comes in various configurations, such as a grid and T-shaped structure. Ureteral stents incorporate retaining structures at both ends of the renal pelvis and bladder. These retaining structures are typically formed by curling a tubular structure. Other shapes include balloons, trumpets, umbrellas, coils, and barbs. These retaining structures prevent displacement of the stent tube and are crucial for ensuring the proper function of the ureteral stent.

[0003] Postoperative placement of a ureteral stent is a common procedure for endoscopic renal and ureteral surgery. Millions of ureteral stents are placed annually, with durations ranging from a few days to several months. However, many patients experience varying degrees of discomfort after surgery, impacting their daily lives and work abilities. Urinary tract irritation and pain are the primary causes of these discomforts. Current research suggests that a key cause of these discomforts is urine reflux caused by elevated bladder pressure.

[0004] There are three main solutions for reducing vesicopelvic reflux. Various one-way valve structures are designed within the lumen of the ureteral stent, such as the patent with authorization publication number CN206403899U. A one-way valve is provided at the end of the ureteral stent, such as the patent with authorization publication number CN204563249U. By placing the tubular structure of the ureteral stent within the ureter outside the bladder wall, the anti-reflux structure of the human ureteral vesicoureteral junction is utilized to achieve the desired effect. Implementing a one-way valve within the small lumen of a ureteral stent (less than 2 mm) is difficult (such as the patent with authorization publication number CN206403899U). Furthermore, if the stent is left in place for a long time, the precipitation of urine components in the one-way valve may cause the one-way valve to fail. Furthermore, the one-way valve may also hinder the entry of a guidewire, making it difficult to place the ureteral stent. Furthermore, the passage of the guidewire may affect the structure and function of the one-way valve. Limiting the stent outside the bladder wall section of the ureter can utilize the body's anti-reflux structure, but at the same time it results in incomplete support for the stent, which may lead to poor drainage of urine from the kidneys, and complications such as low back pain and fever. In addition, it is difficult to maintain the exact position of the ureteral stent, and the stent tube may move upward, resulting in an uncertain drainage effect. Adding an additional one-way valve at the end of the ureteral stent (such as the patent with authorization announcement number CN204563249U) increases the length and volume of the stent, increases the irritation symptoms of the stent tube, and easily causes displacement of the stent tube with the discharge of urine during urination, making it difficult to use widely.

[0005] In summary, ureteral stents currently in widespread clinical use can experience reflux, which can easily cause discomfort to patients. However, due to the relatively small size of ureteral stents, it is difficult to install an anti-reflux structure. This, combined with the fact that the anti-reflux structure penetrates the human body, results in incomplete support for the ureteral stent, making it difficult to resolve the ureteral stent reflux issue. Currently, no satisfactory solution exists that can achieve significant anti-reflux effects while maintaining stent functionality.

[0006] Summary of the Invention

[0007] Based on this, the purpose of the present invention is to provide an anti-reflux ureteral stent, which mainly realizes the anti-reflux function through the flap structure on the side wall of the stent tube. This solution does not change the shape of the stent tube, and will not cause additional stimulation to the bladder. It does not affect the ability of the lumen to pass through the guide wire on the side wall of the stent tube, nor does it interfere with the drainage ability of the stent tube. It is easy to implement to solve the shortcomings of the above-mentioned existing technology.

[0008] The present invention provides the following technical solutions, including:

[0009] Pipeline body;

[0010] a first end and a second end, wherein the first end and the second end are respectively arranged at two ends of the pipe body;

[0011] The first end comprises a first end portion and a first retaining structure for being disposed in the kidney, the first retaining structure being disposed at one end of the pipe body, the first end portion being disposed at an end of the first retaining structure away from the pipe body, and an opening being provided on the first end portion;

[0012] The second terminal includes a second end portion and a second retaining structure for being placed in the bladder, the second retaining structure being placed at an end of the conduit body away from the first retaining structure, the second end portion being placed at an end of the second retaining structure away from the conduit body, the second retaining structure and the conduit body within two centimeters of the second retaining structure being provided with a plurality of petal-like structures, the petal-like structures being placed on the side of the conduit wall, not at the second end portion;

[0013] The petal-like structure and the tube wall of the stent together enclose the tube lumen of the stent in the cross section. The outer surface of the petal-like structure is larger than the inner surface of the petal-like structure. When the external pressure of the petal-like structure is greater than the internal pressure of the petal-like structure, the petal-like structure fits against the tube wall, and the tube wall supports the petal-like structure to achieve the closure of the tube lumen. When the external pressure of the petal-like structure is less than the internal pressure of the petal-like structure, the petal-like structure opens to achieve the opening of the tube lumen.

[0014] In one embodiment, the first retaining structure and the second retaining structure are both curled structures, and the petal-shaped structure is arranged on the inner side of the second retaining structure.

[0015] In one embodiment, the petal-shaped structure is provided at a quarter of the second retaining structure close to the second end.

[0016] In one embodiment, the petal-shaped structure gradually narrows at one end close to the second end.

[0017] In one embodiment, the petal-shaped structure and the outer wall of the second retaining structure are bonded together by a water-soluble polymer material.

[0018] In one embodiment, a groove is provided on the outer wall of the petal-shaped structure.

[0019] In one embodiment, the pipe body and the petal-shaped structure are made of different materials.

[0020] In one embodiment, the first end and the side wall of the pipe body are both provided with a plurality of side holes.

[0021] In one embodiment, the groove is a transverse groove.

[0022] Compared to the prior art, the present invention offers the following advantages: the petal-like structure can be implemented using existing stent production processes by adding a simple cutting process, with minimal increase in production costs and high feasibility. Furthermore, the stent's morphology remains unchanged, achieving anti-reflux functionality without increasing side effects. Using the stent according to the present invention eliminates the need to change the surgeon's operating procedures, and does not introduce additional learning costs or risks. In other words, the present invention achieves anti-reflux without increasing costs, generating side effects, or changing operating procedures. The first and second ends of the tubing are provided at either end, with the first end comprising a first retaining structure and the second end comprising a second retaining structure. In actual use, the first end is positioned within the renal pelvis, while the second retaining structure and the tubing's main body, approximately two centimeters proximal to the second retaining structure, are positioned within the bladder. The petal-like structure is provided on the stent within the bladder. When the external pressure on the petal-like structure is less than the internal pressure—that is, when the external pressure on the bladder section of the stent is less than the internal pressure—the internal pressure can propel the petal-like structure open, allowing fluid to flow out smoothly, achieving smooth drainage from the kidney to the bladder. When the external pressure of the petal structure is greater than the internal pressure, that is, when the external pressure of the stent is greater than the internal pressure, the petal structure adheres tightly to the stent wall, providing support for the petal structure. Since the second end has no opening for fluid flow, the petal structure adheres to the wall and isolates the lumen from the outside, preventing external fluid from entering the stent and preventing urine from flowing back into the kidney. Experiments have shown that when the anti-reflux stent and a conventional ureteral stent are placed at the same height in the same bottle of saline, the anti-reflux stent completely eliminates reflux compared to the conventional ureteral stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] FIG1 is a schematic structural diagram of an anti-reflux ureteral stent in one embodiment of the present invention;

[0024] FIG2 is a schematic structural diagram of a second retaining structure of an anti-reflux ureteral stent in one embodiment of the present invention;

[0025] FIG3 is a first cross-sectional view of a petal-shaped structure of an anti-reflux ureteral stent in one embodiment of the present invention;

[0026] FIG4 is a second cross-sectional view of the petal-shaped structure of the anti-reflux ureteral stent in one embodiment of the present invention;

[0027] FIG5 is a cross-sectional view of the second end portion of the anti-reflux ureteral stent according to one embodiment of the present invention.

[0028] Explanation of the main component symbols: 10. Pipe body; 20. First end; 21. First end portion; 22. First retaining structure; 30. Second end portion; 300. Side hole; 31. Second end portion; 32. Second retaining structure; 33. Petal-like structure; 331. Transverse groove; 332. Inner surface; 333. Outer surface; 334. Incision; 40. Guide wire.

[0029] The following specific embodiments will further illustrate the present invention in conjunction with the above-mentioned drawings. DETAILED DESCRIPTION

[0030] To facilitate understanding of the present invention, the present invention will be described more fully below with reference to the accompanying drawings. The drawings illustrate several embodiments of the present invention. However, the present invention may be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a more thorough and comprehensive understanding of the present invention.

[0031] It should be noted that when an element is referred to as being "fixed to" another element, it may be directly on the other element or there may be an intermediate element. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only.

[0032] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. The terms used in this specification of the present invention are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0033] 1 to 5 , which show an anti-reflux ureteral stent according to an embodiment of the present invention, including a pipe body 10 , a first end 20 , and a second end 30 .

[0034] The first end 20 is used to be set in the kidney, and the second end 30 is used to be set in the bladder. The first end 20 and the second end 30 are respectively set at both ends of the pipeline body 10. The first end 20 includes a first end 21 and a first retaining structure 22 for being set in the kidney. The first retaining structure 22 is set at one end of the pipeline body 10, and the first end 21 is set at the end of the first retaining structure 22 away from the pipeline body 10. An opening is provided on the first end 21. The second end 30 includes a second end 31 and a second retaining structure 32 for being arranged in the bladder. The second retaining structure 32 is arranged at the end of the pipeline main body 10 away from the first retaining structure 22. The second end 31 is arranged at the end of the second retaining structure 32 away from the pipeline main body 10. The second end 30 and the part of the stent main body located in the bladder do not have other openings for liquid flow other than the petal structure 33. Only a puncture or incision through which a guide wire can pass is provided at the second end 31. The puncture or incision is closed in a natural state. Specifically, the second end 31 has no opening for liquid flow, only a puncture for the guide wire to pass through. Several petal structures 33 are provided on the second retaining structure 32 and the pipeline main body 10 within two centimeters of the second retaining structure 32. The petal structure 33 is provided on the side of the tube wall, not at the second end 31. Among them, the petal-like structure 33 and the tube wall of the stent together enclose the tube lumen of the stent in the cross section. The outer surface 333 of the petal-like structure 33 is larger than the inner surface 332 of the petal-like structure 33. When the external pressure of the petal-like structure 33 is greater than the internal pressure of the petal-like structure 33, the petal-like structure 33 fits against the tube wall, and the tube wall supports the petal-like structure 33 to achieve the closure of the tube lumen. When the external pressure of the petal-like structure 33 is less than the internal pressure of the petal-like structure 33, the petal-like structure 33 opens to achieve the opening of the tube lumen.

[0035] Specifically, the second retaining structure 32 and the side of the pipe wall of the pipe body 10 are both provided with a plurality of petal-shaped structures 33 , which together with the second retaining structure 32 and the pipe wall of the pipe body 10 in cross section enclose the lumen of the stent.

[0036] It is understood that at this time, the conduit body 10 is placed in the ureter, and the first end 20 and second end 30 are placed in the kidney and bladder, respectively. After urine is produced, it flows to the second end 30 due to the peristaltic movement of the renal pelvic smooth muscle. When the urine pressure in the second retaining structure 32 is higher than the urine pressure in the bladder, the pressure inside the bladder is lower than the pressure in the petal structure 33. At this time, the petal structure 33 opens, the lumen is open, and urine flows out of the conduit body 10. When the pressure inside the bladder is higher than the pressure in the petal structure 33, the petal structure 33 mates with the second end 30 or the conduit body wall structure, and the second end 30 or the conduit body wall structure provides support for the petal structure 33. The petal structure 33 cannot deform into the lumen, thus achieving a closed lumen and preventing urine from flowing into the second retaining structure 32. Since the second end 31 has no opening for liquid flow, only a puncture hole for the guidewire to pass through, urine cannot flow into the second retaining structure 32, thereby achieving an anti-reflux function and improving patient comfort.

[0037] In this embodiment, the petal-like structure 33 and the wall structure of the second end 30 or the pipe body 10 enclose the stent's lumen in cross section. The outer surface 333 of the petal-like structure 33 is larger than the inner surface 332 of the lumen, and maintains sufficient structural strength to maintain the lumen structure. When the external pressure of the petal-like structure 33 is greater than the internal pressure of the petal-like structure 33, the petal-like structure 33 fits with the second end 30 or the pipe body 10 wall structure, and the second end 30 or the pipe body 10 wall structure forms support for the petal-like structure 33. The petal-like structure 33 cannot deform into the lumen, thereby achieving a closed lumen. When the external pressure of the petal-like structure 33 is less than the internal pressure of the petal-like structure 33, the petal-like structure 33 opens, achieving an open lumen, thereby achieving a one-way drainage effect.

[0038] It is worth noting that the petal-like structures 33 can be formed by cutting the existing stent tube structure, or by removing a portion of the stent tube wall and then attaching the petal-like structures 33. The pressure required to open the petal-like structures 33 can be adjusted by adjusting the thickness and size of the base of the petal-like structures 33. The drainage capacity of the petal-like structures 33 can be adjusted by adjusting the length and size of the petal-like structures 33. The incisions 334 can have various shapes, such as L-shaped, sled-shaped, and arc-shaped.

[0039] During specific implementation, when the patient is urinating, the pressure in the bladder increases, and the flap-like structure 33 is pressed against the outer wall of the second retaining structure 32, so that urine does not flow back from the pipe to the kidney. During the drainage of the kidney, the staff then cuts an opening on the first end 21, so that the opening on the first end 21 can allow urine to enter the first retaining structure 22, and then pass through the pipe body 10 and enter the second retaining structure 32. At this time, due to the drainage of urine in the pipe body 10, the pressure of the pipe body 10 is greater than the external pressure, that is, the internal pressure of the flap-like structure 33 is greater than the external pressure, so that the internal pressure pushes the flap-like structure 33 open, and then the urine can smoothly enter the bladder.

[0040] It is understandable that a plurality of side holes 300 are provided on the first end 20 , that is, the side wall of the first retaining structure 22 and the side wall of the pipe body 10 , to facilitate the drainage of urine.

[0041] In some optional embodiments, the first retaining structure 22 is a curled structure.

[0042] It is worth noting that the first retaining structure 22 is arranged in the kidney, and at this time a part of one end of the pipeline body 10 connected thereto will also be arranged in the kidney. The second retaining structure 32 is arranged in the bladder, and a part of the pipeline body 10 connected to the second retaining structure 32 will also be arranged in the bladder. Therefore, the petal-shaped structure 33 can be arranged at one end of the pipeline body 10 close to the second retaining structure 32, or it can be arranged on the second retaining structure 32.

[0043] It should be noted that the pipe body 10, the first end 21, the first retaining structure 22, the second end 31, the second retaining structure 32, and the petal-shaped structure 33 are integrally formed. If the second retaining structure 32 is considered a circular ring, the petal-shaped structure 33 is located within the inner ring of the pipe body 10 or within two centimeters of the second retaining structure.

[0044] In some optional embodiments, the second retaining structure 32 is a curled structure, and the petal-like structure 33 is disposed inside the curled structure, that is, the petal-like structure 33 is disposed inside the second retaining structure 32. This maintains the integrity of the outer tube wall and, in turn, the longitudinal strength of the stent tube. This prevents wrinkles in the stent tube, deformation of the lumen, and difficulty in inserting the stent tube when the stent tube is pushed into the body along the guidewire.

[0045] During actual use, the ureteral stent needs to be put on the guide wire and pushed forward to the appropriate position by the top tube which is also put on the guide wire. If the improvement of the stent tube reduces the longitudinal strength, the stent tube will not be able to be inserted in the conventional way. In the experiment, if the petal-like structure 33 is set on the outside of the curled structure, when the stent tube is pushed into the body along the guide wire, wrinkles will appear on the stent tube, causing the lumen to deform and wrap around the guide wire. The friction force increases, making it difficult to continue to push the stent tube. Setting the petal-like structure 33 on the inside of the curled structure can avoid the decrease in longitudinal strength and ensure that the stent tube can slide smoothly along the guide wire.

[0046] It is worth noting that the second retaining structure 32 is provided with several petal-like structures 33. In this embodiment, there are two petal-like structures 33, which are arranged on the outer wall of the second retaining structure 32. The petal-like structures 33 are located at a quarter of the second retaining structure 32 near the second end 31. This portion is less affected by bladder contractions, and when the bladder contracts, the petal-like structures 33 tend to move with the second end 31, further reducing the deformation of the petal-like structures 33 caused by bladder contractions, thereby reducing the impact of deformation on the anti-reflux ability. In experiments, the petal-like structures 33 farther away from the second end 31 and closer to the pipe body 10 often cannot adhere to the pipe wall when squeezed. As a result, water will flow out from the gap between the pipe wall and the petal-like structures 33, reducing the anti-reflux ability.

[0047] No drainage side hole is provided within two centimeters of the connection between the pipe body 10 and the second retaining structure 32 and on the second end 30 to prevent liquid from flowing back from the drainage side hole.

[0048] Specifically, the second end portion 31 has a puncture or incision 334, which is only used for the guide wire 40 to pass through when the ureteral stent is placed. It is naturally closed when there is no guide wire 40 to prevent the liquid from flowing back through the opening. It should be explained that since the second end portion 31 is arranged at one end of the second retaining structure 32, and the petal-like structure 33 is arranged on the second retaining structure 32, when the petal-like structure 33 is opened, it can play a drainage role. Therefore, the puncture of the second end portion 31 does not need to be used for liquid to pass through.

[0049] Specifically, a plurality of side holes 300 are provided on the side wall of the first end 20 and the pipe body 10 .

[0050] Specifically, the petal-like structure 33 gradually narrows at one end close to the second end portion 31. It can be understood that the petal-like structure 33 is cut out on the outer wall of the second retaining structure 32 in the form of a side cut, so that one end of the petal-like structure 33 is gradually narrowed so that it can better fit the outer wall of the second retaining structure 32.

[0051] In some optional embodiments, the petal-like structure 33 gradually narrows from one end connected to the second retaining structure 32, with a width ranging from 1 / 6 to 1 / 5 of the circumference of the outer wall of the second retaining structure pipe, and a length of approximately 5 times the width. In this way, the free end of the petal-like structure 33 has a smaller mass and can more easily complete the drainage function.

[0052] Specifically, the free end of the petal-like structure 33 can point to the first end 21 to facilitate placement from the kidney to the bladder, or can point to the second end 31 to facilitate placement from the bladder to the kidney.

[0053] In some optional embodiments, the petal structures 33 have the same width, which can also achieve the anti-reflux effect.

[0054] In some optional embodiments, one end of the petal-like structure 33 close to the second end portion 31 gradually narrows, then widens, and finally narrows again, so that the petal-like structure 33 is more convenient to be pushed open.

[0055] It can be understood that since the petal-like structure 33 is close to the second end 31, in a specific implementation, the second end 31 is free, and this part is less affected by the contraction of the bladder. When the bladder contracts, the petal-like structure 33 tends to move with the second end 31, further reducing the deformation of the petal-like structure 33 caused by bladder contraction, and thus reducing the impact of the deformation on the ability to resist reflux.

[0056] In some optional embodiments, the petal-like structure 33 is bonded to the outer wall of the second retaining structure 32 by a water-soluble polymer material. It is understood that when the anti-reflux ureteral stent is placed in the patient's body, the petal-like structure 33 is bonded to the outer wall of the second retaining structure 32 by the water-soluble polymer material, thereby facilitating its placement into the human body. The water-soluble polymer material can be dissolved by the urine produced by the human body, so that the petal-like structure 33 can open and close, thereby enabling the petal-like structure 33 to play an anti-reflux role. In this embodiment, the water-soluble polymer material is fibrin. The direction of the petal-like structure can also be adjusted to accommodate placement from the bladder to the kidney and placement from the kidney to the bladder, respectively, and convenient placement into the body can also be achieved without the use of adhesive material.

[0057] It is worth noting that a transverse groove 331 is provided on the outer wall of the petal-shaped structure 33. Furthermore, there are multiple transverse grooves 331 on the outer wall of the petal-shaped structure 33. In the present embodiment, there is only one transverse groove 331 on the inner wall of the petal-shaped structure 33. By such an arrangement, the pressure difference required to open the petal-shaped structure 33 can be effectively reduced, so that the petal-shaped structure 33 can better play a drainage role.

[0058] In some optional embodiments, the pipe body 10 and the petal-shaped structure 33 are made of different materials. By such an arrangement, the pressure difference required when the petal-shaped structure opens or closes can be effectively reduced.

[0059] In some optional embodiments, the pipe body 10, the first end 20, and the second end 30 are all made of polyurethane or silicone. It is worth noting that the pipe body 10, the first end 21, the first retaining structure 22, the second end 31, the second retaining structure 32, and the petal-shaped structure 33 are all made of polyurethane or silicone.

[0060] It is worth noting that the pipe body 10 and the petal-shaped structure 33 are made of different materials. In this embodiment, the pipe body 10 is made of polyurethane, and the petal-shaped structure 33 is made of silicone.

[0061] The effectiveness of the solution of the present invention is confirmed by the following experiments:

[0062] Materials: A ureteral stent blank, made of the same material (polyurethane) as commercial stents, was provided by the ureteral stent manufacturer. This blank had no side holes, one end was closed, the other open, and had an outer diameter of 6 mm. The closed end of the blank was curled, and the wall was cut to form a 6 mm x 1.5 mm petal-like structure, with the root of the petal pointing toward the open end of the stent, to create the test anti-reflux stent. The closed end of the same ureteral stent blank was opened to simulate a normal ureteral stent.

[0063] Drainage capacity test:

[0064] The open ends of the test anti-reflux stent and a simulated normal stent were placed in a 500 ml infusion bag, and the other ends were placed in a 100 ml measuring cup. The drainage capacity of the two stents was measured at 20 cm H2O and 40 cm H2O pressures, respectively. At 20 cm H2O pressure, the anti-reflux stent drainage volume was 90% of that of a normal ureteral stent, and at 40 cm H2O pressure, the anti-reflux stent drainage volume was 120% of that of a normal ureteral stent.

[0065] Anti-reflux test:

[0066] The flap-shaped end of the test anti-reflux stent and the open end of a simulated normal stent were placed in a 500 ml infusion bag connected to a pressure gauge. The other end was placed in a 100 ml measuring cup, and the drainage capacity of the two stents was measured at 30 cm H2O and 60 cm H2O, respectively. The anti-reflux stent with the flap-shaped structure placed on the stent body and the inner side of the crimping structure achieved complete anti-reflux effect. The stent with the flap-shaped structure placed on the side and outer side of the crimping structure had a drainage capacity of 10-30% of that of a normal stent.

[0067] Anti-reflux experiment under simulated bladder contraction state:

[0068] The flap-like structure end of the test anti-reflux stent and the open end of a simulated normal stent were placed in a 500 ml infusion bag, and the other end was placed in a 100 ml measuring cup. Under 60 cm H2O pressure, the infusion bag was squeezed to deform the ureteral stent, simulating the end-stage bladder emptying. Results: The test anti-reflux stent with the flap-like structure closer to the stent end showed the greatest stability. The closer the flap-like structure was to the stent body, the more susceptible it was to bladder wall compression, resulting in varying degrees of reflux.

[0069] Stent tube pushing experiment:

[0070] Test anti-reflux stents with petal structures in different positions and numbers were prepared. The closed ends of these stent tubes were punctured with a 1.0 mm diameter four-sided needle to facilitate the passage of a guidewire. A 0.88 mm guidewire was passed through the punctured holes and passed through the entire stent. A push tube was placed over the guidewire, supporting the punctured end of the stent and pushing the stent forward. This simulated the process of pushing the stent into the body during surgery. Results: When the petal structure was on the inner side of the curled segment, it had the least effect on the longitudinal strength of the stent tube, and it was able to slide smoothly along the guidewire under the push of the push tube. Petal structures in other positions would cause the stent tube to deform when pushed longitudinally, gripping the guidewire, increasing friction, and making it difficult to slide.

[0071] In summary, the anti-reflux ureteral stent in the above-mentioned embodiment of the present invention is configured by setting a first end 20 and a second end 30 at both ends of the pipe body 10, the first end 20 includes a first retaining structure 22, the second end 30 includes a second retaining structure 32, and a petal structure 33 is provided on the second retaining structure 32. When the external pressure of the pipe body 10 is greater than the internal pressure, the petal structure 33 is tightly attached to the outer wall of the second retaining structure 32, thereby preventing external liquid from entering the second retaining structure 32. When the external pressure of the pipe body 10 is less than the internal pressure, the internal pressure can expand the petal structure 33, thereby allowing the internal liquid to flow out smoothly, thereby realizing one-way drainage of the ureteral stent and avoiding reflux.

[0072] Throughout this specification, reference to terms such as "one embodiment," "some embodiments," "examples," "specific examples," or "some examples" means that a specific feature, structure, material, or characteristic described in conjunction with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

[0073] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

Claims

1. An anti-reflux ureteral stent, characterized in that: include: Pipeline body; A first end and a second end, wherein the first end and the second end are respectively arranged at two ends of the pipe body; The first end comprises a first end portion and a first retaining structure for being arranged in the kidney, the first retaining structure being arranged at one end of the pipe body, the first end portion being arranged at an end of the first retaining structure away from the pipe body, and an opening being arranged on the first end portion; The second end comprises a second end portion and a second retaining structure for being arranged in the bladder, the second retaining structure being arranged at an end of the pipe body away from the first retaining structure, the second end portion being arranged at an end of the second retaining structure away from the pipe body, the second retaining structure and the pipe body within two centimeters of the second retaining structure being provided with a plurality of petal-shaped structures, the petal-shaped structures being arranged on the side of the pipe wall and not at the second end portion; The petal-like structure and the tube wall of the stent together enclose the tube lumen of the stent in cross section, and the outer surface of the petal-like structure is larger than the inner surface of the petal-like structure. When the external pressure of the petal-like structure is greater than the internal pressure of the petal-like structure, the petal-like structure fits against the tube wall, and the tube wall supports the petal-like structure to achieve closure of the tube lumen. When the external pressure of the petal-like structure is less than the internal pressure of the petal-like structure, the petal-like structure opens to achieve opening of the tube lumen.

2. The anti-reflux ureteral stent according to claim 1, characterized in that: The first retaining structure and the second retaining structure are both curled structures, and the petal-shaped structure is arranged on the inner side of the second retaining structure.

3. The anti-reflux ureteral stent according to claim 2, characterized in that: The petal-shaped structure is arranged at a quarter of the second retaining structure close to the second end.

4. The anti-reflux ureteral stent according to claim 1, characterized in that: One end of the petal-shaped structure close to the second end portion gradually narrows.

5. The anti-reflux ureteral stent according to claim 1, characterized in that: The petal-shaped structure is bonded to the outer wall of the second retaining structure through a water-soluble polymer material.

6. The anti-reflux ureteral stent according to claim 1, characterized in that: A groove is arranged on the outer wall of the petal-shaped structure.

7. The anti-reflux ureteral stent according to claim 1, characterized in that: The pipeline body and the petal-shaped structure are made of different materials.

8. The anti-reflux ureteral stent according to claim 1, characterized in that: The first end and the side wall of the pipe body are both provided with a plurality of side holes.

9. The anti-reflux ureteral stent according to claim 6, characterized in that: The groove is a transverse groove.

Citation Information

Patent Citations

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