A distally positioned anti-reflux and antibacterial ureteral stent

Abstract

The present invention relates to the technical field of medical devices, and specifically relates to an anti-reflux and antibacterial ureteral stent tube with distal positioning, which includes a hollow catheter and a one-way drainage component. The hollow catheter is made of a flexible material and can expand radially along its length. The hollow catheter includes a renal pelvis section, a ureter section, and a bladder section that are sequentially connected. The one-way drainage component is arranged in the bladder section and includes a one-way opening. When the internal pressure of the ureter section is greater than the external pressure at the outer end of the bladder section, the one-way opening opens; when the internal pressure of the ureter section is less than the external pressure at the outer end of the bladder section, the one-way opening closes. The pressure required for the one-way drainage component to open its one-way opening can be adjusted. This application solves the problem of urine reflux through the one-way drainage component that can unidirectionally guide urine in the renal pelvis area to the bladder area, and can adjust the pressure for the one-way drainage component to open the one-way opening according to the urination pressure of different patients, generating a filling stimulus for the renal pelvis area and the ureteral cone, significantly enhancing the peristalsis of the ureter, and reducing the urine reflux rate.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a distally positioned anti-reflux and antibacterial ureteral stent tube. Background Art

[0002] In clinical medicine, ureteral stenosis refers to a condition in which part or all of the ureteral lumen is narrower than normal due to various reasons. Although the continuity of the lumen is not interrupted, it has caused upper urinary tract obstruction and hydronephrosis to varying degrees. In addition to congenital causes, inflammation, injury and surgical scars are the main causes. One of the methods for treating the ureter is to place an internal stent in the narrow part of the ureter. The existing technology mainly involves implanting a guide wire into the ureter through a cystoscope or ureteroscope, and then pushing a double "J"-shaped ureteral internal stent along the guide wire. The upper end of the stent is placed in the renal pelvis and the lower end is placed in the bladder. The ureteral stent is one of the commonly used tools in urological surgery. It is often used in kidney stone and ureteral stone surgery, and is also used in ureteroplasty and repair surgery. It is sometimes used to drain hydronephrosis, especially infected hydronephrosis. The ureteral stent temporarily connects the kidney and bladder to ensure that the urine in the kidney is discharged smoothly into the bladder. Although the application of ureteral stents has improved the success rate of surgery, some complications still occur after the placement of ureteral stents, including: bladder ureteral reflux, low back pain after catheterization, hematuria, bladder irritation symptoms, ureteral stent stones, etc. Vesicoureteral reflux is an important problem that needs to be solved urgently, which seriously limits the further improvement of treatment effect.

[0003] The main reason for bladder ureteral urine reflux is that the ureteral stent is a catheter that can drain in both directions. During use, the anti-reflux mechanism of the bladder and ureter disappears. When the pressure in the bladder is greater than the pressure in the renal pelvis and ureter, urine in the bladder will inevitably flow back to the ureter and renal pelvis. In addition, after the catheter is placed, the urine is constantly drained, and the ureter loses the filling stimulation, resulting in a significant weakening or disappearance of ureteral peristalsis, which also increases the urine reflux rate. The consequence of bladder ureteral urine reflux is an increased chance of retrograde kidney infection, which can even be life-threatening in severe cases, greatly undermining the treatment effect.

[0004] Chinese patent CN203749985U discloses an anti-reflux ureteral stent tube, comprising a renal pelvis segment, a ureter segment and a bladder segment connected in sequence, and an anti-reflux baffle is arranged outside the tube wall at the connection between the ureter segment and the bladder segment.

[0005] The anti-reflux baffle of the ureter stent can only prevent the urine in the bladder from flowing back to the gap between the ureter and the ureter segment, but cannot prevent the urine in the bladder from flowing back to the inner cavity of the ureter segment and the renal pelvis, and the effect is not good.

[0006] Chinese Patent CN201752531U discloses a unidirectional drainage ureteral stent tube, which successively consists of a renal pelvis section, a ureteral section, a ureterovesical junction section, and a bladder section from top to bottom. A unidirectional drainage device is provided inside the catheter of the ureterovesical junction section. The unidirectional drainage device is an elastic rectangular rubber flat tube, the opening end of which is expanded into a circle and fixed on the inner wall of the catheter of the ureterovesical junction section, and the closed end is placed on the bladder section side, with the upper and lower tube walls overlapping and closing together.

[0007] The pressure required for the opening and closing of the rectangular rubber flat tube of this ureteral stent tube is certain, while the urethral pressures of different patients are different. When the urethral pressure is less than the pressure required for the opening and closing of the rectangular rubber flat tube, patients have difficulty urinating, which is likely to cause discomfort to the patients. Summary of the Invention

[0008] Based on this, in view of the problems of the prior art, it is necessary to provide a distal-positioned anti-reflux and antibacterial ureteral stent tube, which solves the problems of urine reflux and the urination pressures of different patients through a unidirectional tube with adjustable opening and closing pressure.

[0009] In order to solve the problems of the prior art, the technical solution adopted by the present invention is as follows:

[0010] A distal-positioned anti-reflux and antibacterial ureteral stent tube includes a hollow catheter and a unidirectional drainage member. The hollow catheter is made of a flexible material and can expand radially along it. The hollow catheter includes a renal pelvis section, a ureteral section, and a bladder section that are sequentially connected. The unidirectional drainage member is arranged inside the bladder section. The unidirectional drainage member includes a unidirectional opening. When the pressure inside the ureteral section is greater than the pressure at the outer end of the bladder section, the unidirectional opening opens. When the pressure inside the ureteral section is less than the pressure at the outer end of the bladder section, the unidirectional opening closes. The pressure required for the unidirectional drainage member to open its unidirectional opening is adjustable.

[0011] Preferably, the unidirectional drainage member is a flexible valve. A hollow interlayer is arranged inside the valve. There are at least two valves. The valves are evenly arranged circumferentially inside the bladder section. The valve has a downstream face facing the inner cavity of the ureteral section and a reverse flow concave face facing the outer end of the bladder section. Adjacent valves are in flexible contact with each other.

[0012] Preferably, antibacterial coatings are provided on both the inner and outer circumferential surfaces of the hollow catheter.

[0013] Preferably, the ureteral section can expand and contract along its length direction.

[0014] Preferably, the ureteral section includes a first telescopic section and a second telescopic section. The first telescopic section and the second telescopic section are telescopically fitted along their length directions. The renal pelvis section and the bladder section are respectively arranged at the outer ends of the first telescopic section and the second telescopic section.

[0015] Preferably, the first telescopic section and the second telescopic section are in interference fit.

[0016] Preferably, the ureter segment includes a first telescopic segment and a second telescopic segment. The first telescopic segment and the second telescopic segment are connected along their lengths through a flexible segment, and the inner diameter of the first telescopic segment is greater than the outer diameter of the second telescopic segment. The renal pelvis segment and the bladder segment are respectively arranged at the outer ends of the first telescopic segment and the second telescopic segment.

[0017] Preferably, when the first telescopic segment and the second telescopic segment are in a nested state, they are in interference fit.

[0018] Preferably, the ureter segment is centimeters long in a fully contracted state.

[0019] Preferably, it further includes a distal balloon. The distal balloon is detachably arranged at the outer end of the renal pelvis segment. The distal balloon is communicated with an external second inflation balloon through a second injection tube. The outer diameter of the distal balloon in a contracted state is smaller than the inner diameter of the hollow catheter in an inflated state, the outer diameter of the distal balloon in an inflated state is greater than the outer diameter of the hollow catheter in a contracted state, and the outer diameter of the distal balloon in an inflated state is smaller than the normal inner diameter of the ureter.

[0020] The beneficial effects of this application compared with the prior art are as follows:

[0021] 1. This application solves the clinical need of the conventional ureteral stent tube that urine refluxes to the kidney, causing hydronephrosis and renal region pain, through a one-way drainage part that can unidirectionally guide urine in the renal pelvis area to the bladder area, and can adjust the pressure of the one-way drainage part to open the one-way orifice according to the urination pressure of different patients, so as to generate a filling stimulus to the renal pelvis area and the ureteral cone, which can significantly enhance the peristalsis of the ureter and reduce the urine reflux rate;

[0022] 2. This application solves the problem that the urinary system is repeatedly infected after the placement of an internal ureteral stent tube and long-term use of antibiotics by setting antibacterial coatings on both the inner and outer surfaces of the hollow catheter, reducing the use of antibiotics;

[0023] 3. This application solves the problem that the current covered stent is long and multiple covered stents need to be stacked for patients with a long stenosis segment through a hollow catheter that can be adjusted in length along the length direction. Moreover, when stacking, the surgical technique requirements are high and it needs to be exposed to light for a long time. Therefore, it also reduces the radiation exposure;

[0024] 4. This application reduces the radiation exposure and simplifies the surgical process by setting a distal balloon that can adjust its size at the outer end of the renal pelvis segment. By pulling the distal balloon with a guide wire and blocking it above the stenosis segment, and at the same time moving the hollow catheter to the stenosis segment, during which process, intraoperative X-ray is not required to position the hollow catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 is a side view of the ureteral stent tube of the embodiment;

[0026] Figure 2 is Figure 1 a sectional view taken along the A-A direction

[0027] Figure 3 is a perspective view of the one-way drainage member in the closed state of the embodiment from the first perspective;

[0028] Figure 4 is a perspective view of the one-way drainage member in the closed state of the embodiment from the second perspective;

[0029] Figure 5 is a bottom view of the one-way drainage member in the closed state of the embodiment

[0030] Figure 6 is Figure 5 a sectional view taken along the B-B direction;

[0031] Figure 7 is a perspective view of the one-way drainage member in the open state of the embodiment;

[0032] Figure 8 is an axial sectional view of the ureter segment of Embodiment 1;

[0033] Figure 9 is an axial sectional view of the ureter segment of Embodiment 2 in the nested state;

[0034] Figure 10 is a sectional view of the ureter segment of Embodiment 2 in the fully extended state.

[0035] The reference numerals in the figure are:

[0036] 1a - renal pelvis segment; 1b - ureter segment; 1b1 - first telescopic segment; 1b2 - second telescopic segment; 1b3 - flexible segment; 1c - bladder segment; 2 - one-way drainage member; 2a - hollow interlayer; 2b - downstream face; 2c - upstream concave surface; 3 - distal balloon; 4 - strip-shaped balloon; 5 - first injection tube; 6 - second injection tube. Detailed implementation manners

[0037] To further understand the features, technical means, specific purposes, and functions achieved by the present invention, the present invention will be further described in detail below in conjunction with the accompanying drawings and specific implementation manners.

[0038] As Figure 2 shown:

[0039] A distally positioned anti-reflux antibacterial ureteral stent tube comprises a hollow catheter and a one-way drainage piece 2. The hollow catheter is made of a flexible material and can expand radially. The hollow catheter comprises a renal pelvis segment 1a, a ureter segment 1b and a bladder segment 1c which are connected in sequence. The one-way drainage piece 2 is arranged in the bladder segment 1c. The one-way drainage piece 2 comprises a one-way port. When the internal pressure of the ureter segment 1b is greater than the pressure at the outer end of the bladder segment 1c, the one-way port opens. When the internal pressure of the ureter segment 1b is less than the pressure at the outer end of the bladder segment 1c, the one-way port closes. The pressure required for the one-way drainage piece 2 to open its one-way port is adjustable.

[0040] Based on the above embodiment, the ureter is connected to the renal pelvis area at the top and the bladder area at the bottom. It is a pair of slender tubes in the shape of a flat cylinder with an average diameter of 0.5 to 0.7 cm. The total length of the adult ureter is 25 to 35 cm. It is located behind the peritoneum and vertically descends along the front of the inner side of the psoas major muscle to enter the pelvis. The ureter has three narrow parts: one at the beginning of the ureter at the transition between the renal pelvis and the ureter, one at the entrance of the small pelvis, and the last one at the inside of the bladder wall. These narrow parts are where stones, blood clots and necrotic tissues are easy to stay; the renal pelvis area and the bladder area of ​​the human body are connected through the ureter. When the inner diameter of the ureter is reduced to form a narrow section, it is inconvenient for the renal pelvis area to urinate into the bladder area. Therefore, it is necessary to leave a hollow catheter that can expand its inner diameter in the narrow section to ensure smooth conduction between the renal pelvis area and the bladder area;

[0041] The hollow catheter can be expanded along its radial direction. It can be understood that when the hollow catheter is in a contracted state, its outer diameter is much smaller than the diameter of the stenosis section, so that after the hollow catheter is pushed to the stenosis section, it is expanded by the strip-shaped airbag 4 pre-placed in the hollow catheter. When the hollow catheter is expanded, the expanded hollow catheter can open the stenosis section and be fixed in the ureter in its expanded state, so that the ureter can conduct the renal pelvis area and the bladder area normally.

[0042] During the operation, the hollow catheter in a contracted state is pre-set on the strip-shaped airbag 4 in a contracted state, and the hollow catheter is pushed into the ureter through the guide wire so that the hollow catheter is located in the narrow area. The strip-shaped airbag 4 is inflated through the first inflatable ball outside and the first air injection tube 5 connecting the first inflatable ball and the strip-shaped airbag 4, thereby expanding the hollow catheter, so that the hollow catheter is inflated and the narrow section is opened, so that the ureter can conduct normally to the renal pelvis area and the bladder area;

[0043] After the hollow catheter is expanded, the gas in the strip-shaped airbag 4 is extracted, and the hollow catheter is fixed in the ureter in its expanded state, and the strip-shaped airbag 4 is contracted, and the strip-shaped airbag 4 is extracted from the human body through the guide wire;

[0044] After the hollow catheter is indwelled, the first telescopic section 1b1 is located in the renal pelvis area, the ureteral section 1b is located inside the ureter, and the bladder section 1c is located in the bladder area. When the pressure in the renal pelvis area and the ureteral section 1b is greater than the pressure in the bladder area, the one-way orifice of the one-way drainage member 2 is opened, enabling the urine in the renal pelvis area to flow into the bladder area through the ureteral section 1b. When the pressure in the bladder area is greater than the pressure in the renal pelvis area and the ureteral section 1b, the one-way orifice of the one-way drainage member 2 is closed, preventing the urine from flowing back to the renal pelvis area through the ureteral section 1b.

[0045] The urination pressures in the ureters of different patients are different. Before the operation, according to the urination pressure conditions of different patients, the pressure required for the one-way drainage member 2 to open the one-way orifice, that is, the preset pressure value, is adjusted. When the pressure in the renal pelvis area and the ureteral section 1b is greater than the preset pressure value, the one-way orifice is opened. When the pressure in the renal pelvis area and the ureteral section 1b is less than the preset pressure value, the one-way orifice is closed, making the preset pressure value after adjusting the one-way drainage member 2 slightly less than the urination pressure of the patient. Therefore, the urine in the renal pelvis area and the ureter can exert pressure on their inner walls, which can further exert a filling stimulus on the renal pelvis area and the ureteral cone, significantly enhancing the peristalsis of the ureter and also reducing the urine reflux rate.

[0046] Furthermore, to solve the problem of how to adjust the pressure required for the one-way drainage member 2 to open, as Figure 3 、 Figure 4 、 Figure 6 and Figure 7 shown:

[0047] The one-way drainage member 2 is a flexible valve. A hollow sandwich 2a is provided inside the valve. There are at least two valves. The valves are evenly arranged circumferentially in the bladder section 1c. The valve has a downstream facing surface 2b facing the lumen of the ureteral section 1b and an upstream concave surface 2c facing the outer end of the bladder section 1c. Adjacent valves are in flexible contact with each other.

[0048] Based on the above embodiment, the valve includes a downstream facing surface 2b and an upstream concave surface 2c. The valves are arranged circumferentially in the bladder section 1c and adjacent valves are in flexible contact with each other, so that the contact surface forms a one-way orifice that can selectively open and close. Since the downstream facing surface 2b faces the lumen of the ureteral section 1b and the upstream concave surface 2c faces the outer end of the bladder section 1c, when the valve is subjected to the pressure from the renal pelvis area to the bladder area, the downstream facing surface 2b is not easily subjected to pressure, making the valve easily deform in the direction of the bladder area, thereby opening the one-way orifice. When the valve is subjected to the pressure from the bladder area to the renal pelvis area, the upstream concave surface 2c is subjected to pressure, making the two valves fit tightly together and thus not easily deform, so that the one-way orifice is in a closed state, effectively preventing the urine in the bladder area from flowing back to the renal pelvis area.

[0049] By adjusting the pressure of the hollow interlayer 2a, the elastic coefficient of the overall valve can be changed. When the pressure of the hollow interlayer 2a is relatively high, the valve is not easily deformed under force and is thus not easily opened at the one-way opening. When the pressure of the hollow interlayer 2a is relatively low, the valve is easily deformed under force and is thus easily opened at the one-way opening. Furthermore, by adjusting the pressure of the hollow interlayer 2a according to the patient's urination pressure, the pressure generated by the urine in the renal pelvis area and the ureter can be adjusted, thereby facilitating the filling and stimulation of the renal pelvis area and the ureter, enhancing the peristalsis of the ureter, and reducing the urine reflux rate.

[0050] There is no space between the stent and the ureter, and urine cannot flow through the space between the ureter and the stent. Therefore, the valve can completely control the urine flow direction in the stent tube and can also prevent urine reflux between the stent tube and the ureter.

[0051] Furthermore, the ureteral stent tube provided in the present application is prone to causing urinary tract infections due to long-term indwelling in the urethra. To solve this problem, as Figure 1 shown:

[0052] Antibacterial coatings are provided on both the inner and outer peripheral surfaces of the hollow catheter.

[0053] Based on the above embodiments, the hollow catheter that is long-term indwelling in the ureter is prone to causing urinary tract infections. Urinary tract infection refers to the presence of microbial pathogens in the urinary system, which is the most common form of infection and can lead to frequent urination, urgency, urinary tract irritation, hematuria, and even death. Antibacterial treatment of the ureteral stent tube to obtain a ureteral stent tube that meets clinical requirements has important clinical significance. Loading antibacterial agents on the surface of the pipeline by using coating or grafting methods on the inner and outer surfaces of the hollow catheter can effectively antibacterial to prevent urinary tract infections.

[0054] Furthermore, the hollow catheter provided in the present application still has the defect that it cannot extend along the length direction of the urethral stricture segment. To solve this problem, as Figure 2 shown:

[0055] The ureteral segment 1b can be telescoped along its length direction.

[0056] Based on the above embodiments, the existing ureteral stent tubes are generally 12 centimeters long, and for patients with a relatively long stricture segment, multiple ureteral stent tubes need to be stacked. When stacking, the surgical technique requirements are high, and it requires exposure to X-rays for a long time, which is not beneficial to the health of the patient. By enabling the ureteral segment 1b to be telescoped along its length direction, its length can be adjusted, and thus the length of the ureteral segment 1b can be adjusted according to the length of the stricture segment, thereby avoiding the problem of needing to stack ureteral stent tubes and reducing the exposure time to X-rays.

[0057] Further, as the first embodiment of the present application, to solve the problem of how the ureter segment 1b extends along the length direction, as Figure 8 shown:

[0058] The ureter segment 1b includes a first telescopic segment 1b1 and a second telescopic segment 1b2. The first telescopic segment 1b1 and the second telescopic segment 1b2 are telescopically fitted along their length directions. The renal pelvis segment 1a and the bladder segment 1c are respectively arranged at the outer ends of the first telescopic segment 1b1 and the second telescopic segment 1b2.

[0059] Based on the above embodiment, since the ureter segment 1b includes the first telescopic segment 1b1 and the second telescopic segment 1b2, and the first telescopic segment 1b1 and the second telescopic segment 1b2 are telescopically sleeved together along their length directions, the first telescopic segment 1b1 and the second telescopic segment 1b2 can extend along their length directions, and thus can be adjusted according to the length of the stenosis segment, avoiding the problem of the need to place the ureter segment 1b in a secondary stack due to the excessive length of the stenosis segment.

[0060] Further, the first telescopic segment 1b1 and the second telescopic segment 1b2 provided in the present application still have the defect that they are easily separated when telescopically fitted along the length direction. To solve this problem, as Figure 8 shown:

[0061] The first telescopic segment 1b1 and the second telescopic segment 1b2 are in interference fit.

[0062] Based on the above embodiment, the first telescopic segment 1b1 and the second telescopic segment 1b2 are telescopically fitted along their length directions, so that the first telescopic segment 1b1 and the second telescopic segment 1b2 can be telescoped along their length directions. However, the lengths of the first telescopic segment 1b1 and the second telescopic segment 1b2 cannot be fixed, making the first telescopic segment 1b1 and the second telescopic segment 1b2 easily telescoped by external forces, and thus it is not easy to place the ureter segment 1b. When the first telescopic segment 1b1 and the second telescopic segment 1b2 are in interference fit, a relatively large force needs to be applied between the first telescopic segment 1b1 and the second telescopic segment 1b2 to be telescoped along their length directions. And after adjusting the lengths of the first telescopic segment 1b1 and the second telescopic segment 1b2, the first telescopic segment 1b1 and the second telescopic segment 1b2 are not easily telescoped along the length direction by small external forces, so that the lengths of the first telescopic segment 1b1 and the second telescopic segment 1b2 can be effectively fixed, and thus the first telescopic segment 1b1 and the second telescopic segment 1b2 can be stably placed.

[0063] Further, as the second embodiment of the present application, to solve the problem of how the ureter segment 1b extends along the length direction, as Figure 9 and Figure 10 shown:

[0064] The ureter segment 1b includes a first telescopic segment 1b1 and a second telescopic segment 1b2. The first telescopic segment 1b1 and the second telescopic segment 1b2 are connected along their length directions through a flexible segment 1b3. The inner diameter of the first telescopic segment 1b1 is greater than the outer diameter of the second telescopic segment 1b2. The renal pelvis segment 1a and the bladder segment 1c are respectively arranged at the outer ends of the first telescopic segment 1b1 and the second telescopic segment 1b2.

[0065] Based on the above embodiments, the ureter segment 1b includes a first telescopic segment 1b1 and a second telescopic segment 1b2. The first telescopic segment 1b1 and the second telescopic segment 1b2 are connected along their length directions through a flexible segment 1b3. Since the inner diameter of the first telescopic segment 1b1 is greater than the outer diameter of the second telescopic segment 1b2, the first telescopic segment 1b1 and the second telescopic segment 1b2 can be nested together along their length directions. The first telescopic segment 1b1 and the second telescopic segment 1b2 can still be connected through the flexible segment 1b3 in the nested state. When the first telescopic segment 1b1 and the second telescopic segment 1b2 are in the fully contracted state, the total length of the ureter segment 1b is equal to the length of a single first telescopic segment 1b1. When the first telescopic segment 1b1 and the second telescopic segment 1b2 are in the fully extended state, the total length of the ureter segment 1b is equal to the total length of the first telescopic segment 1b1, the second telescopic segment 1b2, and the flexible segment 1b3. Thus, the length of the ureter segment 1b can be effectively adjusted according to the length of the stenosis segment.

[0066] Furthermore, after the first telescopic segment 1b1 and the second telescopic segment 1b2 provided in this application are connected through the flexible segment 1b3 and nested and matched, there is still a defect that the first telescopic segment 1b1 and the second telescopic segment 1b2 are prone to slide and separate along their length directions. To solve this problem, as Figure 9 and Figure 10 shown:

[0067] The first telescopic segment 1b1 and the second telescopic segment 1b2 are in an interference fit in the nested state.

[0068] Based on the above embodiments, the relative ends of the first telescopic segment 1b1 and the second telescopic segment 1b2 are connected along their length directions through the flexible segment 1b3. Since the inner diameter of the first telescopic segment 1b1 is greater than the outer diameter of the second telescopic segment 1b2, when the first telescopic segment 1b1 and the second telescopic segment 1b2 are nested along their length directions, the first telescopic segment 1b1 and the second telescopic segment 1b2 are prone to expand and contract by themselves under external forces. By making the first telescopic segment 1b1 and the second telescopic segment 1b2 in an interference fit in the nested state, a relatively large force needs to be applied between the first telescopic segment 1b1 and the second telescopic segment 1b2 to expand and contract along their length directions. When the first telescopic segment 1b1 and the second telescopic segment 1b2 are subjected to a relatively small external force, the first telescopic segment 1b1 and the second telescopic segment 1b2 cannot expand and contract along their length directions by themselves. Thus, the ureter segment 1b can be stably indwelled in the ureter.

[0069] Further, to solve the problem of the optimal length of the hollow catheter, as shown in Figure 2:

[0070] The ureteral segment 1b is 15 cm long in the fully contracted state.

[0071] Based on the above embodiments, the total length of the adult ureter is 25 - 35 cm, and the ureteral segment 1b is 15 cm long in the fully contracted state. That is, when the ureteral segment 1b is fully extended, the length of the ureteral segment 1b is about 30 cm. Thus, it can adapt to the length of the stenosis segment while facilitating transportation and packaging.

[0072] Further, the hollow catheter provided in this application needs to determine its indwelling position through a C-arm machine, and the operation is cumbersome. To solve this problem, as shown in Figure 2 :

[0073] It further includes a distal balloon 3. The distal balloon 3 is detachably arranged at the outer end of the renal pelvis segment 1a. The distal balloon 3 is connected to an external second inflation balloon through a second injection tube 6. The outer diameter of the distal balloon 3 in the contracted state is smaller than the inner diameter of the hollow catheter in the inflated state. The outer diameter of the distal balloon 3 in the inflated state is larger than the outer diameter of the hollow catheter in the contracted state. The outer diameter of the distal balloon 3 in the inflated state is smaller than the normal inner diameter of the ureter.

[0074] Based on the above embodiments, the hollow catheter is sleeved on the strip-shaped balloon 4 in the contracted state and sent to the ureter through a guide wire, so that the contracted distal balloon 3 is located above the stenosis segment. Then, air is inflated into the distal balloon 3 through the second inflation balloon and the second injection tube 6. Since the diameter of the distal balloon 3 in the inflated state is larger than the outer diameter of the hollow catheter, and the outer diameter of the distal balloon 3 in the inflated state is smaller than the normal inner diameter of the ureter, the guide wire is pulled. When the inflated distal balloon 3 moves above the stenosis segment, since the inner diameter of the stenosis end is smaller than the outer diameter of the distal balloon 3, the inflated distal balloon 3 cannot pass through the stenosis end. Thus, the inflated distal balloon 3 is blocked above the stenosis segment, and at the same time, the contracted hollow catheter is exactly located in the stenosis segment. Through the external first inflation balloon and the first injection tube 5, gas is injected into the strip-shaped balloon 4, so that the strip-shaped balloon 4 expands, and at the same time, the hollow catheter expands under the internal expansion force, thereby supporting and expanding the stenosis segment. When the hollow catheter reaches the predetermined size, the injection of gas into the strip-shaped balloon 4 is stopped, and the hollow catheter stops deforming and maintains its shape. And if an expansion force is applied to the inner cavity of the hollow catheter again, the hollow catheter will return to its original size, thus facilitating removal; the gas in the distal balloon 3 and the strip-shaped balloon 4 is discharged to the outside of the human body, so that the distal balloon 3 and the strip-shaped balloon 4 are in the contracted state. Also, since the outer diameters of the distal balloon 3 and the strip-shaped balloon 4 in the contracted state are smaller than the inner diameter of the hollow catheter in the inflated state, and since both the distal balloon 3 and the strip-shaped balloon 4 can be separated from the hollow catheter, the distal balloon 3 and the strip-shaped balloon 4 can be withdrawn from the hollow catheter, and then the distal balloon 3 and the strip-shaped balloon 4 are withdrawn from the human body through the guide wire;

[0075] During this process, there is no need to rely on intraoperative X-rays to position the hollow catheter, thereby reducing radiation exposure and simplifying the surgical procedure.

[0076] This application solves the clinical need of conventional ureteral stents that urine refluxes to the kidney, causing hydronephrosis and renal pain through the one-way drainage member 2 that can unidirectionally guide urine in the renal pelvis area to the bladder area, and can adjust the pressure of the one-way drainage member 2 to open the one-way opening according to the urination pressure of different patients, so as to generate a filling stimulus to the renal pelvis area and the ureteral cone, which can significantly enhance the peristalsis of the ureter and reduce the urine reflux rate; and by providing antibacterial coatings on both the inner and outer surfaces of the hollow catheter, it solves the problem of repeated urinary tract infections after the implantation of the ureteral stent, reduces the long-term use of antibiotics, and reduces the use of antibiotics; and by the hollow catheter that can be adjusted in length in the longitudinal direction, it solves the problem that patients with a long stenosis segment need to stack and place covered stents; and by providing a distal balloon at the outer end of the renal pelvis segment 1a that can adjust its size, and then pulling the distal balloon with a guide wire and blocking it above the stenosis segment, while moving the hollow catheter to the stenosis segment. During this process, there is no need for intraoperative X-rays to position the hollow catheter, thereby reducing radiation exposure and simplifying the surgical procedure.

[0077] The above embodiments only represent one or several implementation manners of the present invention, and the description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention should be subject to the appended claims.

Claims

1. A distally positioned anti-reflux antibacterial ureteral stent tube, comprising a hollow catheter and a one-way drainage piece (2), wherein the hollow catheter is made of a flexible material and can expand in its radial direction, wherein the hollow catheter comprises a renal pelvis section (1a), a ureter section (1b) and a bladder section (1c) which are connected in sequence, wherein the one-way drainage piece (2) is arranged in the bladder section (1c), and wherein the one-way drainage piece (2) comprises a one-way opening, wherein when the internal pressure of the ureter section (1b) is greater than the external pressure of the bladder section (1c), the one-way opening is opened, and when the internal pressure of the ureter section (1b) is less than the external pressure of the bladder section (1c), the one-way opening is closed. It is characterized in that The pressure required for the one-way drainage member (2) to open its one-way opening is adjustable; The one-way drainage member (2) is a flexible valve, wherein a hollow interlayer (2a) is arranged inside the valve, and there are at least two valves, which are evenly arranged in the bladder segment (1c) along the circumferential direction, and the valve has a downstream facing surface (2b) facing the inner cavity of the ureter segment (1b), and a reverse flow concave surface (2c) facing the outer end of the bladder segment (1c), and adjacent valves are flexibly abutted; By adjusting the pressure of the hollow interlayer (2a), the elastic coefficient of the entire valve can be changed. When the pressure of the hollow interlayer (2a) is relatively high, the valve is not easily deformed by the force, and thus it is not easy to open the one-way opening. When the pressure of the hollow interlayer (2a) is relatively low, the valve is easily deformed by the force, and thus the one-way opening is easily opened; It also includes a strip-shaped airbag (4) pre-placed in the hollow catheter, the strip-shaped airbag (4) being connected to a first external inflation ball through a first air injection tube (5), so that the strip-shaped airbag (4) expands, thereby expanding the hollow catheter, so that the hollow catheter expands and stretches the narrow section; The device also includes a distal airbag (3), which is detachably arranged at the outer end of the renal pelvis segment (1a), and is connected to a second inflatable ball in the outside through a second air injection tube (6). The outer diameter of the distal airbag (3) in a contracted state is smaller than the inner diameter of the hollow catheter in an expanded state, the outer diameter of the distal airbag (3) in an expanded state is larger than the outer diameter of the hollow catheter in a contracted state, and the outer diameter of the distal airbag (3) in an expanded state is smaller than the normal inner diameter of the ureter.

2. A distally positioned anti-reflux antibacterial ureteral stent according to claim 1, It is characterized in that The inner and outer circumferential surfaces of the hollow catheter are both provided with an antibacterial coating.

3. A distally positioned anti-reflux antibacterial ureteral stent according to claim 1, It is characterized in that The ureter segment (1b) is retractable along its length.

4. A distally positioned anti-reflux antimicrobial ureteral stent according to claim 3, It is characterized in that The ureter section (1b) comprises a first telescopic section (1b1) and a second telescopic section (1b2); the first telescopic section (1b1) and the second telescopic section (1b2) are telescoped together along their length direction; the renal pelvis section (1a) and the bladder section (1c) are respectively arranged at the outer ends of the first telescopic section (1b1) and the second telescopic section (1b2).

5. A distally positioned anti-reflux antimicrobial ureteral stent according to claim 4, It is characterized in that The first telescopic section (1b1) and the second telescopic section (1b2) are interference fit.

6. A distal-positioning anti-reflux and anti-bacterial ureteral stent tube according to claim 3, characterized in that, the ureteral segment (1b) includes a first telescopic segment (1b1) and a second telescopic segment (1b2), the first telescopic segment (1b1) and the second telescopic segment (1b2) are connected along their length directions through a flexible segment (1b3), and the inner diameter of the first telescopic segment (1b1) is greater than the outer diameter of the second telescopic segment (1b2), and the renal pelvis segment (1a) and the bladder segment (1c) are respectively arranged at the outer ends of the first telescopic segment (1b1) and the second telescopic segment (1b2).

7. A distal-positioning anti-reflux and anti-bacterial ureteral stent tube according to claim 6, characterized in that, when the first telescopic segment (1b1) and the second telescopic segment (1b2) are in a nested state, they are in interference fit.

8. A distal-positioning anti-reflux and anti-bacterial ureteral stent tube according to claim 3, characterized in that, the ureteral segment (1b) is 15 cm long in a fully contracted state.

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