Prostatic columnar balloon catheter

Abstract

The application provides a prostate columnar balloon catheter, and relates to the technical field of medical devices, which comprises a connector, one end of the connector being connected with a catheter, one end of the catheter being provided with a catheterization cavity, the catheterization cavity being in a cylindrical shape, a catheterization flushing opening being arranged on the surface of the catheterization cavity, the outer surface of the catheter being provided with a positioning balloon, an anchoring balloon and a split balloon, the split balloon being located at the outermost side, the anchoring balloon being located at the middle, and the positioning balloon being located at the innermost side, the positioning balloon, the anchoring balloon and the split balloon all being inflatable, the prostate columnar balloon catheter is different from the traditional transurethral resection of the prostate and laser vaporization which rely on cutting or thermal energy to destroy tissues, the prostate columnar balloon catheter adopts a mechanical expansion principle, uniform radial force is applied to the prostate capsule through the synergistic effect of the positioning balloon, the anchoring balloon and the split balloon to realize split, and the prostate columnar balloon catheter avoids large trauma and bleeding risk caused by resection operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a prostate columnar balloon catheter. Background Technology

[0002] With the increasing aging of the population, benign prostatic hyperplasia (BPH), a common urological disease in elderly men, is showing a rising incidence rate year by year, directly affecting patients' quality of life and health. BPH not only causes symptoms such as difficulty urinating and urinary retention, but in severe cases, it can also lead to bladder dysfunction and even kidney damage. Therefore, how to safely and effectively treat BPH, 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 (BPH) mainly relies on the following techniques: drug therapy (such as alpha-blockers and 5α-reductase inhibitors), transurethral resection of the prostate (TURP), laser vaporization, and open surgery. Although these methods are widely used clinically, they still have many shortcomings in practice.

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

[0005] Question 2: Transurethral resection of the prostate (TURP), as the "gold standard" treatment, can effectively remove hyperplastic tissue, but it is a relatively invasive procedure with a high risk of bleeding, especially for elderly patients or those with coagulation disorders. Furthermore, postoperative complications such as urinary incontinence or urethral stricture may occur, affecting recovery outcomes.

[0006] Question 3: Minimally invasive techniques such as laser vaporization destroy prostate tissue using heat energy. While these techniques result in less trauma, the equipment is expensive and requires highly skilled operators, making them difficult to widely implement in primary healthcare institutions. Furthermore, laser treatment may cause local tissue necrosis due to thermal damage, increasing the risk of postoperative infection.

[0007] Question 4: Traditional treatments often rely on cutting or vaporization to remove hyperplastic tissue, lacking non-resectable mechanical dilation options. While existing balloon catheter technology can be used for urethral dilation, its function is limited, only temporarily relieving symptoms. It cannot achieve precise dilation of the prostate capsule and lacks real-time positioning and stability control, resulting in short-lasting treatment effects and a high recurrence rate.

[0008] Therefore, a prostate cylindrical balloon catheter is needed to solve the above problems. Summary of the Invention

[0009] Technical problems to be solved

[0010] To address the shortcomings of existing technologies, this invention provides a prostate cylindrical balloon catheter, which solves the problems mentioned in the background section.

[0011] Technical solution

[0012] To achieve the above objectives, the present invention provides the following technical solution: a prostate cylindrical balloon catheter, comprising a connector, one end of which is connected to a catheter, and one end of which is fitted with a urinary catheter lumen. The urinary catheter lumen is cylindrical in shape, and a urinary flushing opening is provided on the surface of the urinary catheter lumen. The outer surface of the catheter is provided with a positioning balloon, an anchoring balloon, and a dilating balloon, with the dilating balloon on the outermost side, the anchoring balloon in the middle, and the positioning balloon on the innermost side. The positioning balloon, anchoring balloon, and dilating balloon can all be inflated, and when fully inflated, they form a complete ellipse. The positioning balloon, anchoring balloon, and dilating balloon are not interconnected. The other end of the connector is connected to a positioning balloon water injection tube, an anchoring balloon water injection tube, a dilating balloon water injection tube, and a draining tube, respectively. A cap is threadedly connected to the end of the draining tube.

[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 dilating balloon water injection tube is provided with a dilating balloon water injection port.

[0014] Preferably, the catheter structure is operated in the following steps during actual application:

[0015] Sp1. Have the patient lie flat with their legs spread in a V-shape in the lithotomy position. Before the procedure, prepare a medical guidewire, medical lubricant, pressure pump, liquid container, traction device, and hemostatic drugs. The surface of the medical guidewire is coated with a hydrophilic coating, and the front end is a flexible circular design with the diameter gradually decreasing to 0.5mm to reduce irritation to the urethral tissue. The pressure pump is connected to the positioning balloon injection port, anchoring balloon injection port, and dilating balloon injection port respectively through a three-way connector. The connector is equipped with an independent switch valve to control the injection and drainage of each balloon.

[0016] Sp2. Measure the length from the bladder neck to the apex of the prostate using an electrocautery, and determine the type of the catheter by combining this with imaging examinations;

[0017] Sp3. Insert the catheter into the bladder along the guidewire, open the cover of the urinary catheter to the outlet, confirm that urine is flowing out through the urinary catheter, then remove the guidewire and inject 300-500ml of liquid into the bladder.

[0018] Sp4. Inject liquid into the positioning balloon through the positioning balloon water injection tube to inflate the positioning balloon and position it below the bladder neck, then close the positioning balloon water injection port;

[0019] Sp5. Liquid is injected into the anchoring balloon through the water injection tube of the anchoring balloon, causing the anchoring balloon to inflate between the bladder neck and the external sphincter, thus completing the anchoring.

[0020] Sp6. Inject liquid into the dilating balloon through the dilating balloon water injection tube until the pressure reaches 2.5 atmospheres, maintain for 3 minutes, then sequentially drain the liquid from the positioning balloon, anchoring balloon and dilating balloon, and remove the catheter.

[0021] Sp7. Use an electrocautery endoscope to observe the dilation effect. If the prostate capsule has not ruptured, repeat steps Sp4-Sp56. If it has ruptured, insert a three-lumen balloon catheter to continuously irrigate the bladder after hemostasis.

[0022] Preferably, in step Sp2, the catheter type is classified into small (<30ml), medium (30-50ml), and large (>50ml) based on the prostate volume, and is determined with the assistance of ultrasound and CT imaging.

[0023] Preferably, in step Sp3, before inserting the guidewire, a medical lubricant is applied to the outer surface of the catheterization cavity, and the injected liquid is physiological saline at 36-38°C.

[0024] Preferably, in step Sp4, the rate at which liquid is injected into the positioning balloon is 5-10 ml / min, and the injection volume is 10-15 ml for small, 15-20 ml for medium, and 20-25 ml for large, depending on the model. After injection, the balloon is sealed by a check valve at the injection port.

[0025] Preferably, in step Sp5, the volume of liquid injected into the anchoring balloon is 15-20ml for small, 20-25ml for medium, and 25-30ml for large, depending on the model. After the anchoring balloon inflates, the catheter is fixed by an external traction force of 0.5-1N. In step Sp6, when liquid is injected into the dilating balloon, the pressure increases by 0.5 atmospheres per minute, the volume of liquid injected is 20-25ml for small, 25-30ml for medium, and 30-35ml for large, depending on the model, and the pressure release rate is 0.2-0.3 atmospheres / second.

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

[0027] Preferably, the positioning balloon water injection tube, the anchoring balloon water injection tube, and the dilating balloon water injection tube are embedded with pressure sensing fibers, which are connected to an external pressure monitoring device to display the pressure of each balloon in real time.

[0028] Beneficial effects

[0029] This invention provides a prostate cylindrical balloon catheter. It has the following beneficial effects:

[0030] 1. Unlike traditional transurethral resection of the prostate (TURP) and laser vaporization, which rely on cutting or thermal energy to destroy tissue, this prostate cylindrical balloon catheter uses a mechanical dilation principle. Through the synergistic action of a positioning balloon, an anchoring balloon, and a dilating balloon, it applies a uniform radial force to the prostate capsule to achieve dilation, avoiding the significant trauma and bleeding risks associated with resection procedures. The pressure is gradually increased to 2.5 atmospheres and slowly released (0.2-0.3 atmospheres / second) during the procedure, effectively reducing tissue damage. This makes it particularly suitable for elderly patients or those with weakened coagulation function, improving treatment safety.

[0031] 2. This invention addresses the shortcomings of existing balloon catheter technologies, which lack real-time positioning and stability control. The catheter utilizes a three-balloon system with clearly defined functions: a positioning balloon precisely positions the catheter below the bladder neck; an anchoring balloon secures the catheter between the bladder neck and the external sphincter; and graduated markings and pressure-sensing fibers monitor position and pressure in real time, ensuring the dilating balloon acts on the target area. External traction (0.5-1N) further enhances stability, overcoming the problems of short-lasting treatment effects and high recurrence rates in traditional techniques.

[0032] 3. In this invention, the catheter rapidly relieves urethral compression by dilating the prostate capsule in one step, making it suitable for patients with mild to severe benign prostatic hyperplasia (prostate volume <30ml to >50ml). Model selection is based on ultrasound and CT imaging, and the operation is simplified to three stages: positioning, anchoring, and dilation, shortening the operation time, improving treatment efficiency, and eliminating the need for expensive equipment, thus reducing costs and facilitating its promotion in primary healthcare institutions.

[0033] 4. This invention operates without thermal energy or resection, avoiding excessive damage to local tissues. Postoperatively, hemostatic drugs are injected through the catheter irrigation opening, and urine and irrigation fluid are continuously drained to maintain bladder cleanliness, significantly reducing the incidence of infection and complications, promoting rapid patient recovery, and improving quality of life. Furthermore, the procedure can be completed using common accessories such as medical guidewires and pressure pumps. The pressure pump independently controls each balloon via a three-way connector and on / off valve, and with calibration markings and pressure monitoring, the operational difficulty is reduced. Even in resource-limited environments, medical personnel can quickly learn to use it and adapt to a wide range of application needs under different medical conditions. Attached Figure Description

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

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

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

[0037] Figure 4 This is a schematic diagram of the overall expansion during the experimental process of this invention;

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

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

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

[0041] Figure 8 This is a table showing the experimental data for catheter stability testing according to the present invention;

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

[0043] Legend:

[0044] 1. Catheter; 2. Catheter cavity; 3. Positioning balloon inflation tube; 4. Positioning balloon inflation port; 5. Anchoring balloon inflation port; 6. Anchoring balloon inflation tube; 7. Dilatation balloon inflation port; 8. Dilatation balloon inflation tube; 9. Connector; 10. Drainage catheter; 11. Cover; 12. Catheter flushing opening; 13. Positioning balloon; 14. Anchoring balloon; 15. Dilatation balloon. Detailed Implementation

[0045] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Specific Implementation Example 1:

[0047] like Figure 1-9As shown, a prostate cylindrical balloon catheter includes a connector 9. One end of the connector 9 is connected to a catheter 1. One end of the catheter 1 is fitted with a urinary catheter lumen 2, which is cylindrical in shape. A urinary flushing opening 12 is provided on the surface of the urinary catheter lumen 2. The outer surface of the catheter 1 is provided with a positioning balloon 13, an anchoring balloon 14, and a dilating balloon 15. The dilating 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 dilating balloon 15 can all be inflated, and when fully inflated, they will form a complete ellipse. The positioning balloon 13, the anchoring balloon 14, and the dilating balloon 15 are not interconnected. The other end of the connector 9 is connected to a positioning balloon water injection tube 3, an anchoring balloon water injection tube 6, a dilating balloon water injection tube 8, and a draining tube 10, respectively. A cap 11 is threadedly connected to the end of the draining tube 10.

[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, and the end of the dilating balloon water injection tube 8 is provided with a dilating balloon water injection port 7.

[0049] In practical applications, the catheter 1 structure is operated sequentially through the following steps:

[0050] Sp1. Have the patient lie flat with their legs spread in a V-shape in the lithotomy position. Before the procedure, prepare a medical guidewire, medical lubricant, pressure pump, liquid container, traction device, and hemostatic drugs. The surface of the medical guidewire is coated with a hydrophilic coating, and the front end is a flexible circular design with the diameter gradually decreasing to 0.5mm to reduce irritation to the urethral tissue. The pressure pump is connected to the positioning balloon injection port 4, the anchoring balloon injection port 5, and the dilating balloon injection port 7 through a three-way connector. The connector is equipped with an independent switch valve to control the injection and drainage of each balloon.

[0051] Sp2. Measure the length from the bladder neck to the apex of the prostate using an electrocautery endoscope, and determine the type of catheter 1 by combining with imaging examinations;

[0052] Sp3. Insert catheter 1 into the bladder along the guidewire, open the cover 11 of the urinary catheter 10 to the outlet, confirm that urine is flowing out through the urinary catheter 10, then pull out the guidewire and inject 300-500ml of liquid into the bladder.

[0053] Sp4. Inject liquid into the positioning balloon 13 through the positioning balloon water injection tube 3 to inflate the positioning balloon 13 and position it below the bladder neck. Then close the positioning balloon water injection port 4.

[0054] Sp5. Liquid is injected into the anchoring balloon 14 through the anchoring balloon water injection tube 6, causing the anchoring balloon 14 to inflate between the bladder neck and the external sphincter, thus completing the anchoring.

[0055] Sp6. Inject liquid into the dilating balloon 15 through the dilating balloon water injection tube 8 until the pressure reaches 2.5 atmospheres. Maintain for 3 minutes, then sequentially drain the liquid from the positioning balloon 13, anchoring balloon 14 and dilating balloon 15, and remove the catheter 1.

[0056] Sp7. Use an electrocautery endoscope to observe the dilation effect. If the prostate capsule has not ruptured, repeat steps Sp4-Sp56. If it has ruptured, insert a three-lumen balloon catheter to continuously irrigate the bladder after hemostasis.

[0057] In step Sp2, the size of catheter 1 is classified into small (<30ml), medium (30-50ml), and large (>50ml) based on the prostate volume, and is determined with the assistance of ultrasound and CT imaging.

[0058] In step Sp3, before inserting the guidewire, apply medical lubricant to the outer surface of the catheter lumen 2, and inject physiological saline at 36-38℃.

[0059] In step Sp4, the rate at which liquid is injected into the positioning balloon 13 is 5-10 ml / min. The injection volume varies depending on the model: 10-15 ml for small, 15-20 ml for medium, and 20-25 ml for large. After injection, the balloon is sealed through the check valve at the injection port 4.

[0060] In step Sp5, the volume of liquid injected into the anchoring balloon 14 is 15-20ml for small, 20-25ml for medium, and 25-30ml for large, depending on the model. 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 dilating balloon 15, the pressure increases by 0.5 atmospheres per minute. The volume of liquid injected is 20-25ml for small, 25-30ml for medium, and 30-35ml for large, depending on the model. The pressure release rate is 0.2-0.3 atmospheres / second.

[0061] The outer surface of the catheter 1 is marked with graduations every 5 mm, and the expansion areas of the positioning balloon 13, anchoring balloon 14 and dilation balloon 15 correspond to the graduations.

[0062] The positioning balloon water injection tube 3, the anchoring balloon water injection tube 6, and the dilating balloon water injection tube 8 are embedded with pressure sensing fibers, which are connected to an external pressure monitoring device to display the pressure of each balloon in real time. Specific Implementation Example 2:

[0064] like Figure 1-9 As shown, the principle behind this method is as follows:

[0065] The prostatic balloon catheter 1 treats benign prostatic hyperplasia (BPH) through mechanical dilation and pressure control. Its working principle relies on the synergistic effect of a three-balloon system, achieving surgical goals through urinary drainage, precise positioning, and tissue dilation, while pressure monitoring and calibration aids ensure the safety and accuracy of the procedure.

[0066] After catheter 1 is inserted into the bladder, urine is drained using urinary catheter 10 to confirm its location, while saline solution is injected to fill the bladder and provide space for subsequent procedures. Positioning balloon 13 is inflated and positioned below the bladder neck, using graduated markings and pressure-sensing fibers to precisely position the catheter and prevent displacement. Anchoring balloon 14 is then inflated between the bladder neck and the external sphincter, using external traction to fix catheter 1 and ensure stability during dilation. Dilation balloon 15 is gradually pressurized to 2.5 atmospheres, applying a uniform radial force to the prostate capsule and maintaining it for a certain period to cause rupture, achieving the therapeutic effect. The pressure is gradually increased and slowly released during the procedure to reduce the risk of tissue damage.

[0067] Throughout the procedure, urine and flushing fluid were drained through catheter 2 and draining tube 10 to maintain bladder cleanliness. After confirming the dilation effect, if the desired result was not achieved, the positioning, anchoring, and dilation procedures were repeated; if successful, hemostasis was achieved and drainage continued. This principle utilizes independent balloon control and pressure regulation to replace traditional cutting methods, effectively reducing trauma and improving treatment outcomes. Specific Implementation Example 3:

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

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

[0071] Patient background: Male, 65 years old, presented with urinary frequency and urgency. An ultrasound examination revealed a prostate volume of 28 ml, and he was diagnosed with mild benign prostatic hyperplasia without significant urinary retention.

[0072] Operation process:

[0073] The patient was placed in the lithotomy position with legs in a V-shape. Preoperatively, the length from the bladder neck to the apex of the prostate was measured using an electroresection endoscope and found to be 3.5 cm. Based on the ultrasound imaging, a small-sized catheter (<30 ml) was selected.

[0074] After applying medical lubricant, insert the catheter along the hydrophilic coating guidewire, open the urinary catheter cover, and after confirming that urine is flowing out, remove the guidewire and inject 300ml of 37℃ physiological saline through the water injection device.

[0075] Inject 10ml of fluid (5ml / min) into the positioning balloon using a pressure pump, inflate it, close the inlet, and position it below the bladder neck.

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

[0077] Inject 20 ml of fluid into the dilating balloon, gradually increase the pressure to 2.5 atmospheres, maintain for 3 minutes, then slowly release and remove the catheter.

[0078] Electrosurgical examination revealed a slight rupture of the prostate capsule. 5 ml of tranexamic acid was injected to stop the bleeding, and a three-lumen catheter was inserted for continuous drainage.

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

[0080] Case Study 2: Treatment of Patients with Moderate Benign Prostatic Hyperplasia and Urinary Retention

[0081] Patient background: Male, 72 years old, presented with difficulty urinating. Ultrasound showed a prostate volume of 42ml and a residual urine volume of 150ml in the bladder. 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 (30-50ml) was selected. The length measured by electrocautery was 4.2cm.

[0084] After inserting the catheter, drain the residual urine through the urinary catheter and inject 400ml of 36℃ normal saline.

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

[0086] 20 ml of fluid was injected into the anchoring balloon, and the catheter was fixed with a traction force of 0.7 N.

[0087] The balloon was ruptured and 25 ml of fluid was injected at a pressure of 2.5 atmospheres. After maintaining this pressure for 3 minutes, the balloon was released. Electrosurgical examination revealed that the capsule had not completely ruptured, so the rupture was repeated once. After the second rupture, the capsule ruptured. 10 ml of thrombin was injected to stop the bleeding, and a drainage bag was connected for continuous flushing.

[0088] Results: Postoperative residual urine volume decreased to 20 ml, urine flow rate increased to 13 ml / s, and the patient's difficulty in urination was relieved.

[0089] Case Study 3: Treatment of Patients with Severe Benign Prostatic Hyperplasia

[0090] Patient background: Male, 80 years old, presented with recurrent urinary retention. Prostate volume was 62ml, residual urine volume in the bladder was 300ml, and imaging showed severe prostate compression of the urethra.

[0091] Operation process:

[0092] A large-sized catheter (>50ml) was selected, with a length of 5.0cm. After insertion, residual urine was drained, and 500ml of 38℃ normal saline was injected. A positioning balloon was injected with 20ml of fluid (10ml / min), and an anchoring balloon with 25ml of fluid was injected. Traction was applied at 1N for fixation. A dilation balloon was then injected with 30ml of fluid, and the pressure was gradually increased to 2.5 atmospheres and maintained for 3 minutes. The capsule was checked and found not to have ruptured. The procedure was repeated, with the maintenance time extended to 4 minutes. After the second dilation, the capsule ruptured. 10ml of tranexamic acid was injected to stop the bleeding, and drainage continued for 3 days.

[0093] Results: Postoperative residual urine volume decreased to 30 ml, urine flow rate reached 12 ml / s, and patient symptoms improved significantly. Specific Implementation Example 4:

[0095] like Figure 1-9 As shown, Figures 6-8 All of these are experimental data from the present invention, wherein Figure 6 To test the balloon performance of small, medium, and large catheters on simulated prostate models (silicone material, volumes of 30ml, 50ml, and 70ml), the data in the table shows that the dilation balloon is effective for models of different volumes at 2.5 atmospheres, and the rupture rate increases with increasing fluid volume. Figure 7 The data were used to test the effect of pressure release rate on tissue damage in porcine bladder tissue. The balloon was expanded and inflated to 2.5 atmospheres. The data showed that a release rate of 0.2-0.3 atmospheres / second resulted in minimal damage, meeting the design requirements. Figure 8 The experimental data tested the anti-slip capability of the anchoring balloon in a simulated urethral environment by applying different traction forces. The data showed that a traction force of 0.5-1N balances stability and safety, making it suitable for clinical application.

[0096] at the same time Figure 9 This image illustrates the changes in key parameters during prostate balloon catheterization. It includes three sub-figures showing the changes in balloon pressure, balloon diameter, and prostate capsule stress over time. The horizontal axis represents time (in seconds), and the vertical axes represent pressure (atmospheres), diameter (cm), and stress (MPa), respectively. The following is an explanation of the images:

[0097] The first subplot, "Balloon Pressure Changes Over Time," shows the pressure changes of the positioning balloon (blue), anchoring balloon (green), and dilating balloon (red). The positioning balloon pressure began to rise at 120 seconds, reaching approximately 0.9 atmospheres at 180 seconds and remaining stable; the anchoring balloon pressure began to rise at 180 seconds, reaching approximately 1.1 atmospheres at 240 seconds and maintaining that level; the dilating balloon pressure gradually increased from 240 seconds, rising at a rate of 0.5 atmospheres per minute, reaching 2.5 atmospheres at approximately 360 seconds, maintaining that level until 420 seconds (3 minutes), and then releasing to 0 at a rate of 0.25 atmospheres per second between 420 and 430 seconds, meeting the pressure control and release rate requirements of the technical solution.

[0098] The second subplot, "Balloon Diameter Changes Over Time," reflects the changes in the inflated diameter of each balloon, in cm. The positioning balloon diameter increased from 0 to approximately 2.5 cm and stabilized between 120 and 180 seconds; the anchoring balloon diameter increased to approximately 3.0 cm between 180 and 240 seconds; and the dilation balloon diameter increased to approximately 4.0 cm and remained at that size between 240 and 420 seconds, subsequently decreasing rapidly to 0 with pressure release. The changes in balloon diameter are consistent with the pressure curve, demonstrating the direct impact of injection volume and pressure on inflation.

[0099] The third subfigure, "Stress in the Prostatic Capsule over Time," shows the stress response of the prostatic capsule under the action of the dilating balloon, in MPa. The stress begins to increase with increasing balloon pressure from 240 seconds, reaching a peak of approximately 0.05 MPa at 360 seconds, maintaining this level until 420 seconds, and then rapidly decreasing to zero with pressure release. The peak stress reflects the mechanical expansion of the prostatic capsule by the dilating balloon, sufficient to cause capsule rupture. The zero stress after pressure release indicates that the procedure was completed without further damage.

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

[0101] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising a reference structure" does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes the element.

[0102] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A prostate cylindrical balloon catheter, characterized in that: Includes a connector (9), one end of which is connected to a catheter (1), and one end of the catheter (1) is fitted with a urinary catheter cavity (2). The urinary catheter cavity (2) is cylindrical in shape, and a urinary flushing opening (12) is provided on the surface of the urinary catheter cavity (2). The outer surface of the catheter (1) is provided with a positioning balloon (13), an anchoring balloon (14), and a dilating balloon (15). The dilating 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 dilating balloon (15) can all be inflated, and after all three are fully inflated... It will form a complete ellipse. The positioning balloon (13), anchoring balloon (14) and dilating balloon (15) are not connected. The other end of the connector (9) is connected to the positioning balloon water injection tube (3), anchoring balloon water injection tube (6), dilating balloon water injection tube (8) and urination tube (10), respectively. The end of the urination tube (10) is threaded with a cover (11). 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 dilating balloon water injection tube (8) is provided with a dilating balloon water injection port (7).

2. The prostate cylindrical balloon catheter according to claim 1, characterized in that: In practical applications, the catheter (1) structure is operated sequentially through the following steps: Sp1. Have the patient lie flat with their legs spread in a V-shape and take the lithotomy position. Before the operation, you need to prepare a medical guidewire, medical lubricant, pressure pump, liquid container, traction device and hemostatic drugs. The surface of the medical guidewire is coated with a hydrophilic coating and the front end is a flexible circular design with the diameter gradually reduced to 0.5mm to reduce the stimulation of urethral tissue. The pressure pump is connected to the positioning balloon water inlet (4), anchoring balloon water inlet (5) and dilating balloon water inlet (7) respectively through a three-way connector. The connector is equipped with an independent switch valve to control the water injection and drainage of each balloon. Sp2. The length from the bladder neck to the apex of the prostate is measured using an electrocautery endoscope, and the model of the catheter (1) is determined in conjunction with imaging examinations; Sp3, insert the catheter (1) into the bladder along the guidewire, open the cover (11) of the urinary catheter (10), and after confirming that urine is flowing out through the urinary catheter (10), pull out the guidewire and inject 300-500ml of liquid into the bladder; Sp4. Inject liquid into the positioning balloon (13) through the positioning balloon water injection tube (3) to inflate the positioning balloon (13) and position it below the bladder neck, and then close the positioning balloon water injection port (4). Sp5. Liquid is injected into the anchoring balloon (14) through the water injection tube (6) of the anchoring balloon, so that the anchoring balloon (14) expands between the bladder neck and the external sphincter to complete the anchoring. Sp6. Inject liquid into the dilating balloon (15) through the dilating balloon water injection tube (8) until the pressure reaches 2.5 atmospheres. After maintaining this pressure for 3 minutes, drain the liquid from the positioning balloon (13), anchoring balloon (14) and dilating balloon (15) in sequence, and then pull out the catheter (1). Sp7. Use an electrocautery endoscope to observe the dilation effect. If the prostate capsule has not ruptured, repeat steps Sp4-Sp56. If it has ruptured, insert a three-lumen balloon catheter to continuously irrigate the bladder after hemostasis.

3. The prostate cylindrical balloon catheter according to claim 2, characterized in that: In step Sp2, the type of catheter (1) is determined based on the prostate volume and with the assistance of ultrasound and CT images.

4. The prostate cylindrical balloon catheter according to claim 3, characterized in that: In step Sp3, before inserting the guidewire, a medical lubricant is applied to the outer surface of the catheterization cavity (2), and the injected liquid is physiological saline at 36-38°C.

5. A prostate cylindrical balloon catheter according to claim 3, characterized in that: In step Sp4, the rate at which liquid is injected into the positioning balloon (13) is 5-10 ml / min, and after injection, the balloon is closed by the check valve at the water inlet (4).

6. A prostate cylindrical balloon catheter 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 dilating balloon (15), the pressure increases by 0.5 atmospheres per minute and the pressure release rate is 0.2-0.3 atmospheres / second.

7. The prostate cylindrical balloon catheter according to claim 1, characterized in that: The outer surface of the catheter (1) is marked with graduations every 5 mm, and the expansion areas of the positioning balloon (13), anchoring balloon (14) and dilation balloon (15) correspond to the graduations.

8. A prostate cylindrical balloon catheter according to claim 1, characterized in that: The positioning balloon water injection tube (3), the anchoring balloon water injection tube (6), and the dilating balloon water injection tube (8) are embedded with pressure sensing fibers and connected to an external pressure monitoring device to display the pressure of each balloon in real time.

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