Prostate columnar balloon catheter and application thereof

Abstract

The invention provides a prostate columnar balloon catheter and application thereof, and relates to the technical field of medical instruments.The prostate columnar balloon catheter comprises a connector, one end of the connector is connected with a catheter, one end of the catheter is provided with a catheterization cavity, the catheterization cavity is cylindrical, and the surface of the catheterization cavity is provided with a catheterization flushing opening; a positioning balloon, an anchoring balloon and a dilation balloon are arranged on the outer surface of the catheter, the dilation balloon is located on the outermost side, the anchoring balloon is located in the middle, the positioning balloon is located on the innermost side, and the positioning balloon, the anchoring balloon and the dilation balloon can be expanded. According to the prostate columnar balloon catheter, the mechanical dilation principle is adopted, uniform radial force is applied to a prostate capsule to achieve dilation through the synergistic effect of the positioning balloon, the anchoring balloon and the dilation balloon, and large trauma and bleeding risks caused by resection operation are avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a prostate columnar balloon catheter and its application. Background Art

[0002] With the aggravation of population aging, benign prostatic hyperplasia (BPH), as a common urological disease in elderly men, has an increasing incidence year by year, directly affecting the quality of life and health status of patients. Benign prostatic hyperplasia can not only cause symptoms such as difficulty in urination and urinary retention, but may also lead to bladder dysfunction or even renal function damage in severe cases. Therefore, how to safely and effectively treat benign prostatic hyperplasia, relieve urethral compression and restore normal urinary function has become an important research direction in the field of urology.

[0003] Currently, the treatment of benign prostatic hyperplasia mainly relies on the following technical means: drug treatment (such as α-blockers and 5α-reductase inhibitors), transurethral resection of the prostate (TURP), laser vaporization, and open surgery. Although these methods are widely used clinically, there are still many deficiencies in actual operation:

[0004] Problem 1: Although drug treatment is simple and non-invasive, its effect is slow and it is only suitable for patients with mild symptoms. For moderate to severe benign prostatic hyperplasia, drugs are difficult to effectively relieve urethral compression, and long-term use may cause side effects such as sexual dysfunction or hypotension, resulting in a decrease in patient compliance.

[0005] Problem 2: As the "gold standard" treatment method, transurethral resection of the prostate (TURP) can effectively remove hyperplastic tissue, but the surgical trauma is large and the bleeding risk is relatively high, especially for elderly patients or patients with coagulation disorders. In addition, complications such as urinary incontinence or urethral stricture may occur after surgery, affecting the recovery effect.

[0006] Problem 3: Minimally invasive techniques such as laser vaporization destroy prostate tissue through heat energy. Although the trauma is small, the equipment cost is expensive, and the technical requirements for operators are high, making it difficult to be widely promoted in primary medical institutions. At the same time, laser treatment may cause local tissue necrosis due to thermal damage, increasing the risk of postoperative infection.

[0007] Problem 4: Traditional treatment methods mostly rely on cutting or vaporization to remove hyperplastic tissue, lacking a non-resectional mechanical dilation solution. Although the existing balloon catheter technology can be used for urethral dilation, its function is single, it can only temporarily relieve symptoms, cannot achieve precise splitting of the prostate capsule, and lacks real-time positioning and stability control, resulting in an unsatisfactory treatment effect and a high recurrence rate.

[0008] Therefore, a prostate columnar balloon catheter and its application are needed to solve the above problems. Summary of the Invention

[0009] Technical Problem to be Solved

[0010] In view of the deficiencies of the prior art, the present invention provides a prostatic columnar balloon catheter and its application, which solves the problems in the above background art.

[0011] Technical Solution

[0012] To achieve the above objectives, the present invention is realized through the following technical solutions: A prostatic columnar balloon catheter and its application, including a connector, one end of the connector is connected with a catheter, one end of the catheter is equipped with a urine drainage cavity, the shape of the urine drainage cavity is cylindrical, the surface of the urine drainage cavity is provided with urine drainage and irrigation openings, the outer surface of the catheter is provided with a positioning balloon, an anchoring balloon and a dilation balloon, the dilation balloon is on the outermost side, the anchoring balloon is in the middle, and the positioning balloon is on the innermost side. The positioning balloon, the anchoring balloon and the dilation balloon can all be inflated, and after they are fully inflated, they will form a complete ellipse. The positioning balloon, the anchoring balloon and the dilation balloon are not connected to each other. The other end of the connector is respectively connected with a positioning balloon water injection tube, an anchoring balloon water injection tube, a dilation balloon water injection tube and a urine drainage tube, and the end of the urine drainage tube is threadedly connected with a baffle.

[0013] Preferably, the end of the positioning balloon water injection tube is provided with a positioning balloon water injection port, the end of the anchoring balloon water injection tube is provided with an anchoring balloon water injection port, and the end of the dilation balloon water injection tube is provided with a dilation balloon water injection port.

[0014] Preferably, during the actual application process of the catheter structure, the following steps are sequentially carried out for operation:

[0015] Sp1. Let the patient lie flat, with the legs spread apart in a V shape, take the lithotomy position. Before the operation, it is necessary to prepare a medical guide wire, medical lubricant, pressure pump, liquid container, traction device and hemostatic drugs. The surface of the medical guide wire is coated with a hydrophilic coating, and the front end is designed as a flexible circle, with the diameter gradually shrinking to 0.5 mm to reduce the irritation to the urethral tissue. The pressure pump is respectively connected to the positioning balloon water injection port, the anchoring balloon water injection port and the dilation balloon water injection port through a three-way joint, and the joint is provided with an independent switch valve for controlling the water injection and drainage of each balloon;

[0016] Sp2. Use a resectoscope to measure the length from the bladder neck to the apex of the prostate, and determine the model of the catheter in combination with imaging examinations;

[0017] Sp3. Insert the catheter into the bladder along the guide wire, open the baffle of the urine drainage tube, the leakage port, after confirming the urine outflow through the urine drainage tube, pull out the guide wire, and inject 300 - 500 ml of liquid into the bladder;

[0018] Sp4. Inject liquid into the positioning balloon through the positioning balloon water injection tube, causing the positioning balloon to expand and locate below the bladder neck opening, and then close the positioning balloon water injection port;

[0019] Sp5. Inject liquid into the anchoring balloon through the anchoring balloon water injection tube, causing the anchoring balloon to expand between the bladder neck opening and the external sphincter to complete the anchoring;

[0020] Sp6. Inject liquid into the dilation balloon through the dilation balloon water injection tube until the pressure reaches 2.5 atmospheres. After maintaining for 3 minutes, sequentially drain the liquid in the positioning balloon, anchoring balloon, and dilation balloon, and then pull out the catheter;

[0021] Sp7. Use a resectoscope to observe the dilation effect. If the prostatic capsule is not ruptured, repeat steps Sp4 - Sp6. If it is ruptured, after hemostasis, insert a three - lumen balloon catheter to continuously irrigate the bladder.

[0022] Preferably, in step Sp2, the catheter model is divided into small <30 ml, medium 30 - 50 ml, and large >50 ml according to the prostate volume, and is determined with the assistance of ultrasound and CT images.

[0023] Preferably, in step Sp3, before inserting the guide wire, apply medical lubricant on the outer surface of the urinary catheter cavity, and the injected liquid is normal saline at 36 - 38 °C.

[0024] Preferably, in step Sp4, the speed of injecting liquid into the positioning balloon is 5 - 10 ml / min, and the injection volume is 10 - 15 ml for small size, 15 - 20 ml for medium size, and 20 - 25 ml for large size according to the model. After injection, it is sealed by the check valve of the positioning balloon water injection port.

[0025] Preferably, in step Sp5, the injection volume of injecting liquid into the anchoring balloon is 15 - 20 ml for small size, 20 - 25 ml for medium size, and 25 - 30 ml for large size according to the model. After the anchoring balloon expands, fix the catheter with an external traction force of 0.5 - 1 N. In step Sp6, when injecting liquid into the dilation balloon, the pressure increases by 0.5 atmosphere per minute, and the injection volume is 20 - 25 ml for small size, 25 - 30 ml for medium size, and 30 - 35 ml for large size according to the model. The pressure release speed is 0.2 - 0.3 atmosphere / second.

[0026] Preferably, the outer surface of the catheter is provided with scale marks at intervals of 5 mm, and the expansion areas of the positioning balloon, anchoring balloon, and dilation balloon correspond to the scale marks.

[0027] Preferably, the positioning balloon water injection tube, the anchoring balloon water injection tube, and the dilation balloon water injection tube are embedded with pressure sensing fibers, which are connected to an external pressure monitoring device for real-time display of the pressures of the respective balloons.

[0028] Beneficial effects

[0029] The present invention provides a prostatic columnar balloon catheter and its application. It has the following beneficial effects:

[0030] 1. Different from the traditional transurethral resection of the prostate and laser vaporization that rely on cutting or thermal energy to destroy tissues, the prostatic columnar balloon catheter of the present invention adopts the principle of mechanical dilation. Through the synergistic action of the positioning balloon, the anchoring balloon, and the dilation balloon, a uniform radial force is applied to the prostatic capsule to achieve dilation, avoiding the large trauma and bleeding risks brought by resection operations. During the operation, the pressure is gradually increased to 2.5 atmospheres and slowly released (0.2 - 0.3 atmospheres / second), effectively reducing tissue damage, especially suitable for elderly patients or patients with weak coagulation function, and improving the treatment safety.

[0031] 2. Aiming at the deficiency of the existing balloon catheter technology in lacking real-time positioning and stability control, the catheter in the present invention has a clear division of labor through the three-balloon system: the positioning balloon fits precisely below the bladder neck for positioning, the anchoring balloon fixes the catheter between the bladder neck and the external sphincter, and cooperates with the scale markings and pressure sensing fibers to monitor the position and pressure in real time, ensuring that the dilation balloon acts on the target area. The external traction force (0.5 - 1 N) further enhances the stability, overcoming the problems of short-lasting treatment effect and high recurrence rate in the traditional technology.

[0032] 3. In the present invention, the catheter dilates the prostatic capsule in one step, quickly relieving urethral compression, and is suitable for patients with mild to severe prostatic hyperplasia (prostatic volume < 30 ml to > 50 ml). The model selection is combined with ultrasound and CT images, and the operation steps are simplified into three stages: positioning - anchoring - dilation, shortening the operation time, improving the treatment efficiency. At the same time, it does not require expensive equipment support, reduces costs, and is convenient for promotion in primary medical institutions;

[0033] 4. The present invention works in a non-thermal energy and non-resection manner, avoiding excessive local tissue damage. After the operation, hemostatic drugs are injected through the catheterization and irrigation opening and the urine and irrigation fluid are continuously drained to keep the bladder clean, significantly reducing the incidence of infection and complications, promoting the rapid recovery of the patient, improving the quality of life. At the same time, in the actual operation process, common accessories such as a medical guide wire and a pressure pump can be equipped to complete the operation. The pressure pump independently controls each balloon through a three-way joint and a switching valve, and cooperates with the scale markings and pressure monitoring to reduce the operation difficulty. Even in an environment with limited resources, medical staff can quickly get started and meet the wide application requirements of different medical conditions. Brief description of the drawings

[0034] Figure 1 This is the overall structure diagram of the present invention;

[0035] Figure 2 This is the schematic diagram of the semi-inflation of the balloon of the present invention.

[0036] Figure 3 This is the schematic diagram of the inflation of the balloon of the present invention;

[0037] Figure 4 This is the overall inflation schematic diagram during the experiment of the present invention;

[0038] Figure 5 This is the schematic diagram of the initial position during the experiment of the present invention;

[0039] Figure 6 This is the experimental data table of the balloon pressure and inflation effect of the present invention;

[0040] Figure 7 This is the experimental data table of the pressure release and tissue damage of the present invention;

[0041] Figure 8 This is the experimental data table of the catheter stability test of the present invention;

[0042] Figure 9 This is the simulation diagram of the present invention.

[0043] Legend:

[0044] 1. Catheter; 2. Urinary catheter lumen; 3. Positioning balloon water injection tube; 4. Positioning balloon water injection port; 5. Anchoring balloon water injection port; 6. Anchoring balloon water injection tube; 7. Dilation balloon water injection port; 8. Dilation balloon water injection tube; 9. Connector; 10. Urination tube; 11. Cover; 12. Urinary catheter flushing opening; 13. Positioning balloon; 14. Anchoring balloon; 15. Dilation balloon. Specific embodiments

[0045] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention. Specific Embodiment 1:

[0047] As Figures 1-9As shown in the figure, a prostate columnar balloon catheter and its application include a connector 9. One end of the connector 9 is connected to a catheter 1. One end of the catheter 1 is equipped with a urine drainage cavity 2. The shape of the urine drainage cavity 2 is cylindrical. The surface of the urine drainage cavity 2 is provided with urine drainage and flushing openings 12. The outer surface of the catheter 1 is provided with a positioning balloon 13, an anchoring balloon 14, and a dilation balloon 15. The dilation balloon 15 is on the outermost side, the anchoring balloon 14 is in the middle, and the positioning balloon 13 is on the innermost side. The positioning balloon 13, the anchoring balloon 14, and the dilation balloon 15 can all expand, and when all three are fully expanded, they will form a complete oval. The positioning balloon 13, the anchoring balloon 14, and the dilation balloon 15 are not connected to each other. The other end of the connector 9 is respectively connected to a positioning balloon water injection tube 3, an anchoring balloon water injection tube 6, a dilation balloon water injection tube 8, and a urine drainage tube 10. The end of the urine drainage tube 10 is threadedly connected with a retaining cap 11.

[0048] The end of the positioning balloon water injection tube 3 is provided with a positioning balloon water injection port 4. The end of the anchoring balloon water injection tube 6 is provided with an anchoring balloon water injection port 5. The end of the dilation balloon water injection tube 8 is provided with a dilation balloon water injection port 7.

[0049] During the actual application process of the catheter 1 structure, the following steps are sequentially carried out for operation:

[0050] Sp1. Let the patient lie flat with the legs spread apart in a V shape, take the lithotomy position. Before the operation, it is necessary to prepare a medical guide wire, medical lubricant, pressure pump, liquid container, traction device, and hemostatic drugs. The surface of the medical guide wire is coated with a hydrophilic coating, and the front end is designed with a flexible circle, with the diameter gradually shrinking to 0.5 mm to reduce the irritation to the urethral tissue. The pressure pump is respectively connected to the positioning balloon water injection port 4, the anchoring balloon water injection port 5, and the dilation balloon water injection port 7 through a three-way joint. The joint is provided with an independent switch valve for controlling the water injection and drainage of each balloon;

[0051] Sp2. Use a resectoscope to measure the length from the bladder neck to the prostate apex, and determine the model of the catheter 1 in combination with imaging examinations;

[0052] Sp3. Insert the catheter 1 into the bladder along the guide wire. Open the retaining cap 11 of the urine drainage tube 10 to expose the leakage port. After confirming the urine flow through the urine drainage tube 10, pull out the guide wire and inject 300 - 500 ml of liquid into the bladder;

[0053] Sp4. Inject liquid into the positioning balloon 13 through the positioning balloon water injection tube 3 to make the positioning balloon 13 expand and be positioned below the bladder neck, and then close the positioning balloon water injection port 4;

[0054] Sp5. Inject liquid into the anchoring balloon 14 through the anchoring balloon water injection tube 6 to make the anchoring balloon 14 expand between the bladder neck and the external sphincter to complete the anchoring;

[0055] Sp6. Inject liquid into the dilation balloon 15 through the dilation balloon water injection tube 8 until the pressure reaches 2.5 atmospheres. After maintaining for 3 minutes, sequentially drain the liquid in the positioning balloon 13, the anchoring balloon 14, and the dilation balloon 15, and then pull out the catheter 1.

[0056] Sp7. Observe the dilation effect using a resectoscope. If the prostatic capsule is not ruptured, repeat steps Sp4 - Sp56. If it is ruptured, insert a three - lumen balloon catheter after hemostasis and continuously irrigate the bladder.

[0057] In step Sp2, the model of the catheter 1 is divided into small (less than 30 ml), medium (30 - 50 ml), and large (more than 50 ml) according to the prostate volume, and is determined with the assistance of ultrasound and CT images.

[0058] In step Sp3, before inserting the guide wire, apply a medical lubricant on the outer surface of the urinary catheter cavity 2, and the injected liquid is normal saline at 36 - 38 °C.

[0059] In step Sp4, the speed of injecting liquid into the positioning balloon 13 is 5 - 10 ml / min. The injection volume is 10 - 15 ml for small size, 15 - 20 ml for medium size, and 20 - 25 ml for large size according to the model. After injection, it is sealed through the check valve of the positioning balloon water injection port 4.

[0060] In step Sp5, the injection volume of injecting liquid into the anchoring balloon 14 is 15 - 20 ml for small size, 20 - 25 ml for medium size, and 25 - 30 ml for large size according to the model. After the anchoring balloon 14 expands, fix the catheter 1 with an external traction force of 0.5 - 1 N. In step Sp6, when injecting liquid into the dilation balloon 15, the pressure increases by 0.5 atmosphere per minute. The injection volume is 20 - 25 ml for small size, 25 - 30 ml for medium size, and 30 - 35 ml for large size according to the model. The pressure release speed is 0.2 - 0.3 atmosphere / second.

[0061] The outer surface of the catheter 1 is provided with scale marks at intervals of 5 mm, and the expansion areas of the positioning balloon 13, the anchoring balloon 14, and the dilation balloon 15 correspond to the scale marks.

[0062] The positioning balloon water injection tube 3, the anchoring balloon water injection tube 6, and the dilation balloon water injection tube 8 are embedded with pressure - sensing fibers, which are connected to an external pressure monitoring device for real - time display of the pressure of each balloon. Specific Embodiment Two:

[0064] As Figures 1-9 shown, the working principle of this method is as follows:

[0065] The prostate columnar balloon catheter 1 treats benign prostatic hyperplasia through mechanical dilation and pressure control. Its working principle relies on the synergistic effect of the three-balloon system, achieving the surgical goal through catheter drainage, precise positioning, and tissue dilation, and ensuring the safety and accuracy of the operation with the aid of pressure monitoring and scale assistance.

[0066] After the catheter 1 is inserted into the bladder, the urine drainage tube 10 is used to drain urine to confirm the position. At the same time, normal saline is injected to fill the bladder, providing an operating space for the subsequent steps. After the positioning balloon 13 expands and fits under the bladder neck, the catheter is precisely positioned by combining the scale markings and pressure-sensing fibers to prevent displacement. The anchoring balloon 14 then expands between the bladder neck and the external sphincter, fixing the catheter 1 through external traction to ensure stability during the dilation process. The dilation balloon 15 is gradually pressurized to 2.5 atmospheres, applying a uniform radial force to the prostatic capsule. After maintaining for a certain period, the capsule is split to achieve the therapeutic effect. During the operation, the pressure is gradually increased and slowly released to reduce the risk of tissue damage.

[0067] Throughout the process, urine and irrigation fluid are drained through the catheter lumen 2 and the urine drainage tube 10 to keep the bladder clean. After confirming the dilation effect, if it does not meet the expectation, the positioning, anchoring, and dilation operations are repeated; if successful, hemostasis is performed and continuous drainage is maintained. This principle uses independent balloon control and pressure regulation to replace the traditional cutting method, effectively reducing trauma and improving the therapeutic effect. Specific Embodiment Three:

[0069] As Figures 1-9 shown, the following are the applications of the present invention in different patient scenarios:

[0070] Case 1: Treatment of patients with mild benign prostatic hyperplasia:

[0071] Patient background: A 65-year-old male presented with frequent urination and urgency. After ultrasound examination, the prostate volume was 28 ml, and he was diagnosed with mild benign prostatic hyperplasia without obvious urinary retention.

[0072] Operation process:

[0073] The patient was placed in the lithotomy position with the legs in a V shape. Before the operation, the length from the bladder neck to the prostatic apex was measured with a resectoscope to be 3.5 cm, and a small-sized catheter (<30 ml) was selected in combination with the ultrasound image.

[0074] After applying medical lubricant, the catheter was inserted along the hydrophilic-coated guide wire. The urine drainage tube cover was opened, and after confirming the urine flow, the guide wire was removed. 300 ml of 37°C normal saline was injected through the infusion device.

[0075] 10 ml of liquid (5 ml / min) was injected into the positioning balloon through the pressure pump. After expansion, the infusion port was closed and positioned under the bladder neck.

[0076] Inject 15 ml of liquid into the anchoring balloon, and apply a traction force of 0.5 N to fix the catheter after inflation.

[0077] Inject 20 ml of liquid into the dilation balloon, gradually increase the pressure to 2.5 atmospheres, maintain for 3 minutes and then slowly release, and then pull out the catheter.

[0078] Transurethral resection endoscopy examination shows that the prostatic capsule is slightly cracked. Inject 5 ml of tranexamic acid to stop bleeding, and insert a three-lumen catheter for continuous drainage.

[0079] Results: The postoperative urinary flow rate increased from 8 ml / s before the operation to 15 ml / s, the symptoms were significantly improved, and there were no complications during the recovery period.

[0080] Case 2: Treatment of patients with moderate benign prostatic hyperplasia complicated with urinary retention

[0081] Patient background: A 72-year-old male presented with dysuria. Ultrasound showed that the prostate volume was 42 ml and the residual urine volume in the bladder was 150 ml. He was diagnosed with moderate benign prostatic hyperplasia.

[0082] Operation process:

[0083] The patient was placed in the lithotomy position, and a medium-sized catheter (30 - 50 ml) was selected. The length measured by the transurethral resection endoscope was 4.2 cm.

[0084] After inserting the catheter, drain the residual urine through the urinary drainage tube, and inject 400 ml of normal saline at 36°C.

[0085] Inject 15 ml of liquid (8 ml / min) into the positioning balloon and position it below the bladder neck.

[0086] Inject 20 ml of liquid into the anchoring balloon and fix the catheter with a traction force of 0.7 N.

[0087] Inject 25 ml of liquid into the dilation balloon. When the pressure reaches 2.5 atmospheres, maintain for 3 minutes and then release. The transurethral resection endoscopy examination shows that the capsule is not completely cracked, and repeat the dilation once. After the second dilation, the capsule is cracked. Inject 10 ml of thrombin to stop bleeding and connect the drainage bag for continuous irrigation.

[0088] Results: The postoperative residual urine volume decreased to 20 ml, the urinary flow rate increased to 13 ml / s, and the patient's dysuria was relieved.

[0089] Case 3: Treatment of patients with severe benign prostatic hyperplasia

[0090] Patient background: An 80-year-old male presented with recurrent urinary retention. The prostate volume was 62 ml and the residual urine volume in the bladder was 300 ml. Imaging showed that the prostate severely compressed the urethra.

[0091] Operation process:

[0092] Select a large-sized catheter (>50 ml), measure a length of 5.0 cm, drain the residual urine after inserting the catheter, inject 500 ml of normal saline at 38°C, inject 20 ml of liquid into the positioning balloon (10 ml / min), inject 25 ml of liquid into the anchoring balloon, fix with a traction force of 1 N, inject 30 ml of liquid into the dilation balloon, gradually increase the pressure to 2.5 atmospheres, maintain for 3 minutes, check that the capsule has not ruptured, repeat the operation and extend the maintenance time to 4 minutes. After the second dilation, the capsule ruptured, inject 10 ml of tranexamic acid to stop bleeding, and continuously drain for 3 days.

[0093] Results: The residual urine volume after surgery decreased to 30 ml, and the urine flow rate reached 12 ml / s, and the patient's symptoms were significantly improved. Specific Example 4:

[0095] As Figures 1-9 shown, Figures 6-8 All are the experimental data of the present invention, where Figure 6 is to test the balloon performance of small, medium and large catheters on a simulated prostate model (silicone material, volume 30 ml, 50 ml, 70 ml). From the tabular data, it can be concluded that the dilation balloon is effective for models of different volumes at 2.5 atmospheres, and the rupture rate increases with the increase of the injection volume. Figure 7 The data is to test the effect of the pressure release rate on tissue damage on porcine bladder tissue. The dilation balloon is filled with water to 2.5 atmospheres. From the data, it can be concluded that the release rate of 0.2 - 0.3 atmospheres / second causes the least damage and meets the design requirements. Figure 8 The experimental data in

[0096] simultaneously Figure 9 shows the changes in key parameters during the operation of the prostate columnar balloon catheter. It contains three subgraphs, which respectively represent the changes of balloon pressure, balloon diameter and prostate capsule stress over time. The horizontal axis is time (unit: second), and the vertical axes are pressure (atmosphere), diameter (cm) and stress (MPa) respectively. The following is the analysis of the picture:

[0097] The first sub - figure "Balloon pressure change over time" shows the pressure changes of the positioning balloon (blue), the anchoring balloon (green), and the dilation balloon (red). The pressure of the positioning balloon starts to rise at 120 seconds, reaches approximately 0.9 atmospheres at 180 seconds and remains stable; the pressure of the anchoring balloon starts to rise at 180 seconds, reaches approximately 1.1 atmospheres at 240 seconds and maintains; the dilation balloon starts to increase pressure gradually at 240 seconds, with the pressure rising at a rate of 0.5 atmospheres per minute, reaches 2.5 atmospheres at approximately 360 seconds, maintains until 420 seconds (3 minutes), and then is released to 0 at a rate of 0.25 atmospheres per second between 420 - 430 seconds, meeting the requirements of pressure control and release speed in the technical solution.

[0098] The second sub - figure "Balloon diameter change over time" reflects the change in the inflated diameter of each balloon, with the unit of cm. The diameter of the positioning balloon increases from 0 to approximately 2.5 cm and stabilizes between 120 - 180 seconds, the diameter of the anchoring balloon increases to approximately 3.0 cm between 180 - 240 seconds, the diameter of the dilation balloon increases to approximately 4.0 cm and maintains between 240 - 420 seconds, and then rapidly decreases to 0 with the release of pressure. The change in the diameter of each balloon is consistent with the pressure curve, reflecting the direct impact of the injection volume and pressure on inflation.

[0099] The third sub - figure "Prostate capsule stress change over time" shows the stress response of the prostate capsule under the action of the dilation balloon, with the unit of MPa. The stress starts to rise with the increase in the pressure of the dilation balloon at 240 seconds, reaches a peak of approximately 0.05 MPa at 360 seconds, maintains until 420 seconds, and then rapidly drops to 0 with the release of pressure. The stress peak reflects the mechanical dilation effect of the dilation balloon on the prostate capsule, which is sufficient to cause the capsule to rupture. At the same time, the stress returns to zero after the pressure is released, indicating that the operation is completed and there is no continuous damage.

[0100] Overall, the simulation results clearly demonstrate the step - by - step operation and pressure control logic of the three balloons in the technical solution, verify the realization of the positioning, anchoring, and dilation functions, and at the same time confirm the feasibility of the dilation effect through stress analysis.

[0101] It should be noted that, in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "comprising", "including" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device comprising a series of elements not only includes those elements, but also includes other elements not expressly listed, or further includes elements inherent to such process, method, article or device. Without further limitation, an element defined by the statement "comprising a reference structure" does not exclude the existence of additional identical elements in the process, method, article or device comprising the element.

[0102] Although the embodiments of the present invention have been shown and described, those of ordinary skill in the art can understand that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A prostate columnar balloon catheter and its application, characterized in that: The invention comprises a connector (9), one end of which is connected to a catheter (1), one end of which is provided with a urinary catheter cavity (2), the urinary catheter cavity (2) being cylindrical in shape, the surface of which is provided with an opening (12) for urinary catheterization and flushing, the outer surface of which is provided with a positioning balloon (13), an anchoring balloon (14) and a dilating balloon (15), the dilating balloon (15) being located at the outermost side, the anchoring balloon (14) being located in the middle, and the positioning balloon (13) being located at the innermost side. The positioning balloon (13), the anchoring balloon (14) and the dilating balloon (15) can all be expanded, and when fully expanded, they will form a complete ellipse. The positioning balloon (13), the anchoring balloon (14) and the dilating balloon (15) are not connected to each other. The other end of the connector (9) is respectively connected to the positioning balloon water injection tube (3), the anchoring balloon water injection tube (6), the dilating balloon water injection tube (8) and the urination tube (10). The end of the urination tube (10) is threadedly connected with a blocking cover (11).

2. A prostate columnar balloon catheter and its use according to claim 1, characterized in that: The end of the positioning balloon water injection tube (3) is provided with a positioning balloon water injection port (4), the end of the anchoring balloon water injection tube (6) is provided with an anchoring balloon water injection port (5), and the end of the expansion balloon water injection tube (8) is provided with a expansion balloon water injection port (7).

3. A prostate columnar balloon catheter and its use according to claim 2, characterized in that: During actual application, the catheter (1) structure is operated in the following steps: Sp1, let the patient lie flat with legs spread in a V shape, taking lithotomy position. Before the operation, it is necessary to prepare a medical guide wire, medical lubricant, pressure pump, liquid container, traction device and hemostatic drug. The surface of the medical guide wire is coated with a hydrophilic coating, and the front end is a flexible circular design, and the diameter gradually decreases to 0.5 mm to reduce the stimulation to the urethral tissue. The pressure pump is connected to the positioning balloon water injection port (4), the anchoring balloon water injection port (5) and the expansion balloon water injection port (7) respectively through a three-way connector. An independent switch valve is provided on the connector to control the water injection and drainage of each balloon; Sp2, using a resectoscope to measure the length from the bladder neck to the prostate tip, and combining imaging examination to determine the model of the catheter (1); Sp3, insert the catheter (1) into the bladder along the guide wire, open the cover (11) of the urinary tube (10), drain the outlet, confirm that urine flows out through the urinary tube (10), then pull out the guide wire, and inject 300-500 ml of liquid into the bladder; Sp4, injecting liquid into the positioning balloon (13) through the positioning balloon water injection tube (3) to expand the positioning balloon (13) and position it below the bladder neck, and then closing the positioning balloon water injection port (4); Sp5, injecting liquid into the anchoring balloon (14) through the anchoring balloon water injection tube (6), so that the anchoring balloon (14) expands between the bladder neck and the external sphincter, thereby completing anchoring; Sp6, injecting liquid into the dilating balloon (15) through the dilating balloon water injection tube (8) until the pressure reaches 2.5 atmospheres, maintaining for 3 minutes, then draining the liquid in the positioning balloon (13), the anchoring balloon (14) and the dilating balloon (15) in turn, and pulling out the catheter (1); Sp7. Use an electroresectoscope to observe the effect of dilation. If the prostate capsule has not ruptured, repeat steps Sp4-Sp56. If it has ruptured, stop bleeding and insert a three-chamber balloon catheter to continuously flush the bladder.

4. A prostate columnar balloon catheter and its use according to claim 3, characterized in that: In the step Sp2, the model of the catheter (1) is determined based on the volume of the prostate and with the assistance of ultrasound and CT images.

5. The prostate columnar balloon catheter and its use according to claim 3, characterized in that: In the step Sp3, before inserting the guide wire, a medical lubricant is applied to the outer surface of the catheter cavity (2), and the injected liquid is a physiological saline solution at 36-38°C.

6. The prostate columnar balloon catheter and its use according to claim 3, characterized in that: In the step Sp4, the speed of injecting liquid into the positioning balloon (13) is 5-10 ml / min, and after the water is injected, the positioning balloon water injection port (4) is closed by a check valve.

7. The prostate columnar balloon catheter and its use according to claim 3, characterized in that: In step Sp5, after the anchoring balloon (14) is inflated, the catheter (1) is fixed by an external traction force of 0.5-1N. In step Sp6, when liquid is injected into the expansion balloon (15), the pressure increases by 0.5 atmospheres per minute, and the pressure release rate is 0.2-0.3 atmospheres / second.

8. The prostate columnar balloon catheter and its use according to claim 1, characterized in that: The outer surface of the catheter (1) is provided with scale marks every 5 mm, and the expansion areas of the positioning balloon (13), the anchoring balloon (14) and the dilation balloon (15) correspond to the scale marks.

9. A prostate columnar balloon catheter and its use according to claim 8, characterized in that: The positioning balloon water injection tube (3), the anchoring balloon water injection tube (6) and the expansion balloon water injection tube (8) are embedded with pressure sensing fibers and are connected to an external pressure monitoring device for real-time display of the pressure of each balloon.

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