Visual balloon type urethral dilatation device

Abstract

The visual balloon type urethral dilation device comprises a urethral endoscope and a balloon dilator arranged in the urethral endoscope in a penetrating mode, and the urethral endoscope and the balloon dilator are matched with the urethra of the human body. The observation field of view of the urethra endoscope covers the dilation balloon of the balloon dilator, and visual dilation of the dilation balloon is achieved. The balloon dilator is provided with an independently-controlled fixing balloon, the fixing balloon and a balloon-shaped cavity in the urethra endoscope probe form a detachable fixing structure, the balloon dilator can penetrate through a middle shaft of the probe to move axially when fixing is removed, and the guiding function of the probe is achieved. The balloon dilator can be used in a disposable mode, and cross infection is prevented. And the probe is provided with a panoramic camera and a light supplementing lamp which are symmetrical, so that the visualization precision is improved. The urethra dilatation operation accuracy, safety and diagnosis and treatment efficiency are greatly improved from the aspects of high visualization, dilatation precision adjustment and the like.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a visual balloon-type urethral dilation device for the treatment of urethral stricture, which is particularly suitable for precise dilation and real-time monitoring of the urethral stricture segment during minimally invasive urological surgery. Background Technology

[0002] Currently, most urethral dilators used in clinical practice are reusable, and their dilation operation is a typical blind dilation method. This means that medical staff rely entirely on their accumulated clinical experience and operating techniques to judge the insertion depth and dilation force of the instrument when performing urethral dilation, lacking direct visual guidance. This operating mode has significant risks, as it is easy to mistakenly create a "false passage" during dilation, causing secondary damage, aggravating urethral stricture, and bringing additional health risks to patients.

[0003] In cases of urethral stricture, especially urethral stricture remaining after inflammation has healed, the location of the stricture is often not fixed, and the shape and extent of the stricture segment vary from person to person. This further increases the difficulty of blind dilation procedures. At the stricture site, medical staff often encounter difficulties in inserting instruments, and forcibly pushing in for dilation can easily lead to urethral tearing, causing complications such as severe pain and bleeding. In severe cases, it can even cause more serious urethral damage, affecting the patient's urinary function.

[0004] When using existing urethral dilators for treatment, the principle of dilation from thin to thick is usually followed. That is, starting with the smallest dilator inserted into the urethra, gradually replacing it with a larger diameter dilator until the urethral diameter returns to normal. These traditional urethral dilators are mostly metal rod-shaped structures, which are directly inserted into the urethra during use. Afterwards, depending on the patient's urethral dilation recovery, instruments of different diameters are periodically replaced for subsequent treatment. The entire process is always in a state of lack of precise guidance.

[0005] In the field of vasodilation, the visualization operation mode of "balloon dilation + X-ray guidance" is relatively mature. However, when this mode is directly applied to urethral dilation, obvious compatibility problems are exposed, and it cannot meet the clinical needs of urethral dilation.

[0006] On the one hand, the procedure is poorly adaptable and poses radiation hazards. The urethra has a physiological curvature and is adjacent to organs such as the bladder and rectum. X-ray guidance requires large equipment and a dedicated space, and also requires the patient to maintain a fixed position. Furthermore, the balloon inflation and dynamic deformation of the cavity during urethral dilation require the surgeon to adjust the operation in real time, which conflicts with the static position required for X-rays. This not only increases the cost of setting up the space and the complexity of the operation, but the ionizing radiation of X-rays can also cause cumulative health damage to both doctors and patients.

[0007] On the other hand, the visualization accuracy is insufficient. X-rays, relying on contrast agents, can only present the general outline of the urethra, making it difficult to capture details such as subtle mucosal lesions and the layering of strictures. Medical staff cannot accurately determine the range and pressure of balloon dilation, which can still easily lead to risks such as the formation of a "false passage" and urethral perforation, failing to meet the core requirements of accuracy and safety for urethral dilation.

[0008] Therefore, there is an urgent need for a urethral dilation technology solution that is adapted to the anatomical characteristics of the urethra, has higher visualization accuracy, allows for precise adjustment of dilation force, and allows for disposable urethral dilators. Summary of the Invention

[0009] To address the above problems, this invention provides a visual balloon-type urethral dilation device, achieving a technological breakthrough through the following innovations:

[0010] A visual balloon-type urethral dilator includes a balloon dilator whose radial size is adjustable by distal pressure and adapted to the size of the human urethra, and a urethral endoscope positioned next to the balloon dilator and adapted to the size of the human urethra. The balloon dilator includes a dilating balloon and a balloon catheter; the end of the balloon dilator and urethral endoscope entering the urethra is the head, and the operating end is the tail; the dilating balloon is positioned on the periphery of the balloon catheter near the head end and is connected to the distal pressure adjustment device through the tail end of the balloon catheter; the urethral endoscope's field of view covers the dilating balloon. The balloon dilator, in conjunction with the urethral endoscope, visualizes the dilation process, improving operational accuracy and safety.

[0011] The urethral endoscope consists of a probe at the tip and an insertion tube at the tail. The probe is a smooth, rotating structure with an axial tubular perforation along its central axis. A balloon catheter is inserted through this perforation. The insertion of the balloon catheter through the tubular perforation of the urethral endoscope probe simplifies the assembly, ensures smooth insertion, and provides stable guidance for the urethral endoscope via the balloon dilator, improving the accuracy of instrument coordination.

[0012] The balloon dilator and urethral endoscope are connected via a detachable fixation structure. This structure includes a sac-like cavity and a fixing balloon; the sac-like cavity is located inside the probe; the fixing balloon is located at the tail end of the dilated balloon and on the periphery of the balloon catheter; the sac-like cavity adapts to the fixed balloon in its expanded state; the fixing balloon is connected to a distal pressure regulating device via the tail end of the balloon catheter. This detachable fixation structure allows the balloon dilator to guide the urethral endoscope when not fixed, and locks their relative positions when fixed, combining guidance and fixation functions to enhance usability. The fitting of the fixing balloon and sac-like cavity provides a stable fixation, preventing instrument displacement during dilation and ensuring accurate positioning. The balloon dilator in this device is designed for single use and replacement, completely eliminating the risk of cross-infection, ensuring patient safety, and eliminating the need for instrument cleaning, disinfection, and maintenance, thus improving clinical efficiency.

[0013] The balloon catheter incorporates three independent channels: a dilating balloon catheter, a fixing balloon catheter, and a guidewire channel, forming a "one-piece, three-lumen" structure. The dilating balloon catheter connects the dilating balloon to the distal pressure regulating device; the fixing balloon catheter connects the fixing balloon to another distal pressure regulating device; and the guidewire channel extends from the outside of the balloon catheter's tail end to the inside of its tip end without protruding from the balloon catheter's tip. The dilating balloon catheter, fixing balloon catheter, and guidewire channel operate independently, avoiding media interference or operational conflicts between balloon inflation, fixing balloon locking, and guidewire insertion support. This ensures that core functions such as dilation pressure regulation, device fixation, and catheter support do not affect each other, improving operational stability.

[0014] The dilating balloon catheter is connected to the dilating balloon through multiple filling ports; these ports are axially and evenly distributed within the dilating balloon. The multiple axially uniform filling ports ensure even inflation of the dilating balloon, avoiding excessive local compression of the urethral tissue.

[0015] Both the dilating balloon catheter and the fixing balloon catheter are connected to controllable one-way valves at their ends, with the flow direction determined by the media inflow. The dilating balloon catheter, connected to the controllable one-way valve, allows only unidirectional media entry into the dilating balloon, preventing pressure leakage during inflation and ensuring stable and controllable dilation force. Simultaneously, media discharge can be controlled to allow the balloon to contract slowly, avoiding sudden pressure drops that could damage the urethra. The fixing balloon catheter, also connected to the controllable one-way valve, restricts media entry to the fixing balloon, ensuring continuous dilation within the balloon cavity to securely lock the device in position. When release from fixation is required, media discharge can be controlled, allowing the balloon to contract rapidly for convenient and flexible adjustment or withdrawal.

[0016] The guidewire channel has a funnel-shaped inlet at its tail end and a thickened layer at its tip; a support guidewire is placed inside the channel. The funnel-shaped inlet at the tail end facilitates quick and smooth insertion of the support guidewire, reducing operational difficulty; the thickened layer at the tip enhances the rigidity of the catheter tip to improve pushing stability and prevents the support guidewire from protruding, ensuring it remains internal and does not contact the urethral mucosa. The support guidewire provides rigid support for the balloon catheter, preventing bending or deformation during urethral advancement and ensuring smooth device insertion.

[0017] Cameras are mounted on both sides of the probe's head; a supplementary light and an injection port are located next to the cameras; the injection port connects to the injection device at the tail end. The cameras and supplementary light are symmetrically arranged around the probe's axis. This symmetrical arrangement of the cameras and supplementary light around the probe's axis eliminates blind spots, improves the comprehensiveness of visual observation, and clearly captures the state of the dilation balloon and the interior of the urethra. The injection port, located next to the cameras, is used to inject normal saline solution before the procedure to fill and flush the urethra, while also flushing the cameras. Attached Figure Description

[0018] Figure 1 This is a three-dimensional structural diagram of the head segment of a visual balloon-type urethral dilator in Embodiment 1;

[0019] Figure 2 This is a schematic diagram (including cross-section) of the head segment of the urethral endoscope in Example 1;

[0020] Figure 3 A schematic diagram of the overall structure of a balloon dilator;

[0021] Figure 4 for Figure 3 Enlarged view of point A in the image;

[0022] Figure 5 A schematic diagram (including cross-section) of the head section of a balloon dilator;

[0023] Figure 6 for Figure 5 Enlarged view of point B in the image;

[0024] Figure 7 This is a schematic diagram of the axial cross-sectional structure of the head section of a visual balloon-type urethral dilator in Embodiment 1.

[0025] Figure 8 for Figure 7 Enlarged view of point C in the image;

[0026] Figure 9 for Figure 7 Enlarged view of point D in the image; Detailed Implementation

[0027] Example 1

[0028] like Figure 1 As shown, a visualization balloon-type urethral dilation device includes a balloon dilator 1 and a urethral endoscope 2 coaxially arranged with the balloon dilator 1.

[0029] like Figure 3-9As shown, the balloon dilator 1 includes a dilating balloon 12, a fixing balloon 13, and a balloon catheter 14. The end of the balloon dilator 1 and the urethroscope 2 that enters the urethra is designated as the head end, and the operating end as the tail end. Both the dilating balloon 12 and the fixing balloon 13 are positioned around the balloon catheter 14, with the dilating balloon 12 positioned closer to the head end of the balloon catheter 14, allowing direct application to the urethral stricture for dilation. The fixing balloon 13 is positioned closer to the tail end of the dilating balloon 12, providing stable support during dilation to prevent device displacement. The balloon catheter 14 contains three independent lumens: a dilating balloon catheter 141, a fixing balloon catheter 142, and a guidewire channel 143, forming a "one-piece three-lumen" structure, enabling independent operation of each functional channel without interference. The proximal end of the dilating balloon catheter 141 is connected to the dilating balloon 12 via two evenly distributed inflation ports 121, ensuring uniform inflation of the dilating balloon 12. The distal end is connected to a controllable one-way valve, namely the dilating balloon check valve 144, with the flow direction in the media inlet direction, which controls and maintains the inflation pressure of the dilating balloon 12. The proximal end of the fixing balloon catheter 142 is connected to the fixing balloon 13, and the distal end is connected to another controllable one-way valve, namely the fixing balloon check valve 145, with the flow direction in the media inlet direction, which stabilizes the supporting state of the fixing balloon 13 by maintaining the inflation pressure. The guidewire channel 143 extends from the outside of the tail end of the balloon catheter 14 to the inside of its tip end without protruding from the tip end of the balloon catheter 14. A support guidewire 148 is provided inside to improve the overall pushability and positioning accuracy of the balloon dilator 1. The tail end of the guidewire channel 143 has a funnel-shaped inlet 146 to facilitate the insertion of the support guidewire 148. The tip end has a thickened layer 147 to enhance the structural strength of the tip end and prevent the support guidewire 148 from protruding. The balloon dilator 1 is designed for single use to avoid cross-infection and can be replaced with different sizes according to the patient's condition. In different sizes, the dilating balloon 12 is 10-30 mm long and has a diameter of 6-10 mm when dilated, suitable for different degrees of urethral stricture and patients of different body types. The diameter of the undilated balloon 12 is approximately 2 mm, which is similar in size to the balloon catheter 14, facilitating smooth entry into the urethra.

[0030] like Figure 2 , Figure 7 , Figure 9As shown, the urethroscope 2 includes a probe 21 at the tip and an insertion tube 22 at the tail. The probe 21 is a smooth cylindrical structure with a diameter of approximately 5 mm and a length of approximately 7 mm; its extremely short length allows the probe 21 to easily bend at bends in the urethra; the transition between the probe 21 and the outer periphery of the insertion tube 22 adopts a smooth frustum-shaped connection structure, which can reduce resistance during withdrawal. The probe 21 has an axial cylindrical tubular perforation 23 with a diameter of approximately 2.5 mm; the tail of the tubular perforation 23 expands to form a spherical cavity, namely a sac-like cavity 24, which is adapted to the expanded fixed balloon 13, can accommodate the fixed balloon 13, and achieve a stable fit between the two. The insertion tube 22 is a cylindrical flexible tube coaxially arranged with the probe 21, with a diameter of about 4 mm, which combines flexibility and pushability; the middle part is provided with a tubular cavity, namely the insertion lumen 221, which communicates with the tubular perforation 23. The insertion lumen 221 has a diameter of about 2.5 mm and is adapted to the outer wall of the balloon catheter 14, so that the balloon catheter 14 can be smoothly inserted into the tubular perforation 23 and the insertion lumen 221, realizing the coaxial assembly of the two. The probe 21 has two cameras 211, two supplementary lights 212, and one injection port 213. The cameras 211 and supplementary lights 212 are symmetrically arranged around the axis of the probe 21. The supplementary lights 212 provide sufficient illumination. The field of view of the cameras 211 covers the periphery of the dilation balloon 12 and can provide real-time feedback on the dilation site. The injection port 213 is located next to one of the cameras 211 and is used to inject saline solution into the urethra before the operation to fill the urethra for easier operation and to flush the urethra. Saline solution can also be injected to flush the camera 211 when it is obscured by urethral contents. Among them, the cameras 211 are panoramic cameras. The two panoramic cameras are integrated through a remote control module to achieve unified aggregation and synchronous processing of multi-view data, forming a complete internal urethral view. Multiple independent wire cavities 222 are provided around the insertion cavity 221, forming an "integrated multi-cavity" structure. The wires 222 are arranged to supply power and transmit data to the camera 211 and the fill light 212, enabling independent transmission of power and signals.

[0031] The usage process of Example 1 is as follows:

[0032] 1. Device fitting: Select a disposable balloon dilator of the appropriate size according to the degree of urethral stricture and body type of the patient.

[0033] 2. Guidewire assembly: Insert the support guidewire 148 into the guidewire channel 143 through the funnel-shaped inlet 146 at the tail end of the balloon catheter 14, ensuring that the tip of the guidewire reaches the thickened layer 147 at the tip of the guidewire channel 143, thereby improving the overall pushability and positioning accuracy of the device.

[0034] 3. Pre-inflation of the fixed balloon: The fixed balloon 13 is inflated by injecting a medium through the fixed balloon catheter 142 to ensure the overall stability of the device and provide basic guidance for urethral insertion.

[0035] 4. Endoscopic-guided insertion: Following the direction of the support guidewire 148, and with the help of the real-time clear view of the urethral endoscope 2, the coaxially assembled balloon dilator 1 and urethral endoscope 2 are slowly inserted into the anterior urethra. The injection device at the operating end injects physiological saline through the injection port 213 to fill the urethra and simultaneously flush the urethra and the camera. Then, the coaxially assembled balloon dilator 1 and urethral endoscope 2 are slowly advanced into the urethra, and the condition of the urethral wall is observed throughout the process to avoid damage to the mucosa.

[0036] 5. Balloon Positioning and Dilation: Under real-time monitoring of the urethral endoscope probe 21, adjust the position of the balloon catheter 14 so that the constricted balloon 12 first enters the urethral stricture. After confirming the correct position, inject the medium into the balloon 12 through the balloon catheter 141. Use the two evenly distributed filling ports 121 to ensure that the balloon expands evenly to the preset diameter. Maintain the filling pressure with the balloon check valve 144 to achieve dilation of the stricture.

[0037] 6. Handling of particularly narrow areas: When the device tip approaches the urethral stricture and it is found that the urethral endoscope 2 probe 21 cannot be directly inserted, the pressure of the medium inside the fixed balloon 13 is released through the fixed balloon check valve 145, causing the fixed balloon 13 to return to its contracted state, and the connection between the balloon dilator 1 and the urethral endoscope 2 is disconnected. Under the real-time long-distance field of view monitoring of the urethral endoscope 2 probe 21, the balloon dilator 1 is inserted into the stricture area for dilation. If further adjustment of dilation or extension of observation time is required, after the stricture area is dilated, the pressure inside the dilation balloon 12 is released to cause it to contract. Guided by the balloon catheter 14, the urethral endoscope 2 probe 21 is slowly pushed into the rear end of the stricture area to comprehensively check the patency and mucosal condition of the posterior urethra.

[0038] 7. Entry into the physiological curvature of the urethra: When the tip of the device approaches the physiological curvature of the urethra and it is found that the urethroscope 2 probe 21 is difficult to enter directly, the medium pressure in the fixed balloon 13 is released through the fixed balloon check valve 145, so that the fixed balloon 13 returns to the contracted state and the connection between the balloon dilator 1 and the urethroscope 2 is released; under the real-time long-distance field monitoring of the urethroscope 2 probe 21, the balloon dilator 1 in the contracted state slowly passes through the physiological curvature of the urethra alone, guided by the balloon catheter 14, and slowly pushes the urethroscope 2 probe 21 into the rear end of the physiological curvature of the urethra.

[0039] 8. Device Removal and Disposal: After the treatment procedure is completed, release the pressure of the dilation balloon 12 and slowly remove the entire device from the urethra. Since the balloon dilator 1 is a disposable design, dispose of it according to medical waste regulations after removal to avoid cross-infection.

[0040] The above-described embodiments are merely one implementation of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the scope of protection of the present invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A visual balloon-type urethral dilator, characterized in that, It includes a balloon dilator (1) whose radial size is adjusted by distal pressure and is adapted to the size of the human urethra, and a urethral endoscope (2) located next to the balloon dilator (1) and adapted to the size of the human urethra; the balloon dilator (1) includes a dilating balloon (12) and a balloon catheter (14); the end of the balloon dilator (1) and the urethral endoscope (2) entering the urethra is the head, and the operating end is the tail; the dilating balloon (12) is located on the outer periphery of the balloon catheter (14) near the head end, and is connected to the distal pressure adjustment device through the tail end of the balloon catheter (14); the field of view of the urethral endoscope (2) covers the dilating balloon (12).

2. The visual balloon-type urethral dilator according to claim 1, characterized in that, The urethral endoscope (2) includes a probe (21) at the head end and an insertion tube (22) at the tail end. The probe (21) is a rotating structure with a smooth surface and an axial tubular perforation (23) in its central axis. The balloon catheter (14) passes through the tubular perforation (23).

3. The visual balloon-type urethral dilator according to claim 2, characterized in that, The balloon dilator (1) and the urethral endoscope (2) are connected by a detachable fixing structure.

4. The visual balloon-type urethral dilator according to claim 3, characterized in that, The removable fixation structure includes a sac-like cavity (24) and a fixation balloon (13); The sac-like cavity (24) is disposed inside the probe (21); the fixed balloon (13) is disposed at the tail end of the dilating balloon (12) and the outer periphery of the balloon catheter (14); the sac-like cavity (24) is adapted to the fixed balloon (13) in the dilated state; the fixed balloon (13) is connected to the distal pressure regulating device through the tail end of the balloon catheter (14).

5. A visual balloon-type urethral dilator according to claim 4, characterized in that, The balloon catheter (14) has three independent lumens: an inflatable balloon catheter (141), a fixed balloon catheter (142), and a guidewire channel (143), forming a "three-lumen integrated" structure. The inflatable balloon catheter (141) connects the inflatable balloon (12) to the distal pressure regulating device. The fixed balloon catheter (142) connects the fixed balloon (13) to another distal pressure regulating device. The guidewire channel (143) extends from the outside of the tail end of the balloon catheter (14) to the inside of its head end without exiting the head end of the balloon catheter (14).

6. The visual balloon-type urethral dilator according to claim 5, characterized in that, The dilatation balloon catheter (141) is connected to the dilatation balloon (12) through multiple filling ports (121); the filling ports (121) are axially and uniformly distributed within the dilatation balloon (12).

7. A visual balloon-type urethral dilator according to claim 5, characterized in that, The tail ends of the dilating balloon catheter (141) and the fixed balloon catheter (142) are respectively connected to controllable one-way valves with the conduction direction being the medium entry direction.

8. A visual balloon-type urethral dilator according to claim 5, characterized in that, The guide wire channel (143) has a funnel-shaped inlet (146) at its tail end and a thickened layer (147) at its head end; a supporting guide wire (148) is provided inside the guide wire channel (143).

9. A visual balloon-type urethral dilator according to claim 2, characterized in that, The probe (21) has cameras (211) on both sides of its head; a supplementary light (212) and a liquid injection hole (213) are provided next to the cameras (211); the liquid injection hole (213) is connected to the liquid injection device at the tail end.

10. A visual balloon-type urethral dilator according to claim 9, characterized in that, The camera (211) and the fill light (212) are respectively arranged symmetrically around the probe (21).

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