Multi-cavity ureter sheathing canal system integrating flushing and pressure monitoring functions

Abstract

The invention discloses a multi-cavity ureter sheathing canal system integrating flushing and pressure monitoring functions, and relates to the technical field of medical instruments, the multi-cavity ureter sheathing canal system is characterized by comprising a sheathing canal main body and a micro-catheter channel, the micro-catheter channel is integrated in the wall of the sheathing canal main body, and the micro-catheter channel is communicated with the sheathing canal main body. The sheathing canal main body is provided with a main working channel penetrating through the sheathing canal main body, and the micro-catheter channel and the main working channel extend in parallel; a flexible ureteroscope is arranged in the main working channel in a penetrating mode, and a lateral suction connector is arranged at the near end of the main working channel and used for being connected with a negative pressure suction device. The near end of the sheath tube body is connected with a ureter sheath base, and a water sealing cap is connected to an opening in the near end of the ureter sheath base. The system can continuously supplement perfusate to the pelvis during negative pressure suction, maintain the shape of the pelvis, avoid mucosal injury and realize real-time and accurate pressure monitoring in an operation, so that the broken stone removal efficiency and the operation safety are remarkably improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a multi-lumen ureteral sheath system that integrates flushing and pressure monitoring functions. Background Technology

[0002] Ureteroscopic lithotripsy has become the mainstream minimally invasive technique for treating upper urinary tract stones. This procedure usually requires the insertion of a ureteral sheath to establish a channel for the flexible endoscope to enter and exit, to drain irrigation fluid, and to assist in the removal of stone fragments.

[0003] Currently, standard ureteral sheaths used clinically are typically single-lumen or double-lumen. Single-lumen sheaths provide only one main working channel; double-lumen sheaths include one main working channel and one side lumen for pressure measurement. However, existing technology has the following significant drawbacks:

[0004] 1. Fluid dynamics conflict: During negative pressure suction stone removal, the irrigation fluid flows in from the tip of the flexible endoscope, while the negative pressure suction is generated from the end of the sheath or the side cavity. The stone is simultaneously subjected to the opposing forces of flushing and suction. Whether it can be effectively removed depends on the complex local fluid dynamics environment, and the efficiency is unstable, which may lead to stone escape or residue.

[0005] 2. Renal pelvis collapse and mucosal damage: When the perfusion fluid in the renal pelvis is rapidly aspirated, continuous negative pressure suction can lead to renal pelvis collapse. The negative pressure acts directly on the delicate renal pelvis mucosa, not only drastically reducing suction efficiency but also posing a risk of mucosal damage or even tearing. Increasing the flushing of the ureteroscope, however, can increase the risk of stone escape.

[0006] 3. Low stone removal efficiency: Due to the aforementioned fluid conflict and renal pelvis collapse issues, the number of stone fragments that can be removed in a single suction is limited, which prolongs the operation time, affects the stone removal rate, and increases the surgical risk.

[0007] 4. Inaccurate renal pelvis pressure monitoring: Intraoperative monitoring of renal pelvis pressure is crucial for preventing infectious complications caused by excessive renal pelvis pressure. Current techniques typically involve pressure measurement via a dedicated capillary channel on the ureteral sheath or a channel shared with negative pressure suction. The pressure measuring catheter usually requires a rigid catheter designed to prevent collapse; an inner diameter of 0.5mm–1.0mm is generally considered the critical damping region, achieving optimal frequency response and fidelity. Using a rigid catheter can lead to an increase in the outer diameter of the ureteral sheath or a decrease in its inner diameter; the latter results in completely distorted pressure readings when negative pressure is applied, failing to reflect the true renal pelvis pressure and posing a safety hazard.

[0008] 5. After ureteral sheath implantation, it is not easy to inject contrast agents, hemostatic agents, air, treatment or examination drugs into the ureter or renal pelvis without removing the internal guidewire.

[0009] Therefore, there is an urgent need for a new type of ureteral sheath system that can solve the above problems. Summary of the Invention

[0010] The purpose of this invention is to provide a multi-lumen ureteral sheath system integrating irrigation and pressure monitoring functions. This system can continuously replenish irrigation fluid to the renal pelvis during negative pressure suction, maintain the shape of the renal pelvis, avoid mucosal damage, and achieve real-time and accurate pressure monitoring during surgery, thereby significantly improving the efficiency of stone removal and surgical safety. Contrast agents, hemostatic agents, air, and therapeutic or diagnostic drugs can also be injected during sheath insertion to accomplish multiple functions.

[0011] The above-mentioned technical objective of the present invention is achieved through the following technical solution: a multi-lumen ureteral sheath system integrating flushing and pressure monitoring functions, the multi-lumen ureteral sheath system comprising a sheath body and a microcatheter channel, the microcatheter channel being integrated within the wall of the sheath body, the sheath body having a main working channel running through it, the microcatheter channel extending parallel to the main working channel; a ureteroscope is inserted through the main working channel, and a lateral suction interface is provided at the proximal end of the main working channel for connecting a negative pressure suction device; a ureteral sheath base is connected to the proximal end of the sheath body, and a water seal cap is connected to the proximal opening of the ureteral sheath base.

[0012] The present invention is further configured such that the distal opening of the microcatheter channel is flush with or slightly retracted from the tip of the sheath body to avoid interfering with the operation of the ureteroscope and to ensure the accuracy of pressure monitoring and flushing.

[0013] The multi-lumen ureteral sheath system offers the following two options based on the number and functional configuration of the microcatheter channels:

[0014] Option 1: When there are two microcatheter channels, the system is in dual-microcatheter mode. In dual-microcatheter mode, the sheath body is provided with a flushing microcatheter channel and a pressure measuring microcatheter channel respectively. The proximal end of the flushing microcatheter channel is connected to a flushing fluid inlet, and the distal end opens at the tip of the sheath body. The flushing fluid inlet is connected to an infusion pump through a pipe for infusing physiological saline into the renal pelvis. The proximal end of the pressure measuring microcatheter channel is connected to a pressure sensor inlet, and the distal end opens at the tip of the sheath body. The pressure sensor inlet is connected to a pressure gauge for monitoring pressure.

[0015] Option 2: When there is only one microcatheter channel, the system operates in single-microcatheter mode. In this mode, a single-function microcatheter channel is located within the sheath body. A three-way switching valve is located proximal to this single-function microcatheter channel. This valve can be selectively connected to an infusion pump or a pressure gauge to infuse saline solution into the renal pelvis / ureter or monitor pressure. During this process, the single-function microcatheter channel is linked to the flexible ureteroscope, which has an adjustable channel. When performing lithotripsy, the flexible ureteroscope is flushed, and the single-function microcatheter channel within the ureteral sheath measures pressure. When performing negative pressure suction stone removal, the adjustable channel connected to the flexible ureteroscope is switched to a pressure measuring channel via the switching valve, while the microcatheter within the ureteral sheath becomes the water inlet channel, thus completing the functional switching between different stages.

[0016] In summary, the present invention has the following beneficial effects:

[0017] 1. Highly efficient stone removal: Through an independent flushing channel, water is continuously replenished to the deep renal pelvis while suction is applied, forming a stable outward fluid flow from the renal pelvis to the sheath opening. This greatly promotes the movement of stone fragments towards the negative pressure source, solves the problem of water flushing and suction canceling each other out, and significantly improves the amount of stone fragments removed in a single suction session and the stone removal efficiency.

[0018] 2. Avoid tissue damage: Continuous hydration prevents renal pelvis collapse, ensuring that the negative pressure suction always acts on the fluid rather than directly on the mucosa, fundamentally eliminating the risk of renal pelvis mucosal damage caused by negative pressure suction.

[0019] 3. Precise pressure monitoring: The independent pressure measurement channel (or when switching to pressure measurement in single-channel mode) is completely unaffected by the negative pressure suction or high-speed fluid flow in the main channel, and can provide real and continuous intraoperative renal pelvis pressure readings, providing a key guarantee for surgical safety.

[0020] 4. Improve surgical safety: Accurate pressure monitoring combined with controlled irrigation can effectively prevent excessive pressure in the renal pelvis and reduce the risk of postoperative complications such as infection and fever.

[0021] 5. Flexible Adaptability: The dual microcatheter design is particularly suitable for flexible ureteroscopes with smaller outer diameters (such as digital flexible ureteroscopes), ensuring uninterrupted access without sacrificing functionality. The single microcatheter design offers a more cost-effective and widely compatible solution, enabling core functions through external switching.

[0022] 6. Function switching: The function can be switched between the ureteroscopic microcatheter channel and the ureteroscopic microchannel, and the flushing and pressure measurement functions can be switched at any time. This ensures a clear field of vision during the lithotripsy stage and ensures that the renal pelvis is well filled and continuously provides the amount of fluid needed to remove the stones during suction. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the overall structure of the device in Embodiment 1 of the present invention;

[0024] Figure 2 These are schematic diagrams of the cross-sectional pipe distribution and pathways at various locations in embodiments 1 and 2 of the present invention;

[0025] Figure 3 This is a schematic diagram of the overall structure of the device in Embodiment 2 of the present invention.

[0026] In the diagram: 1. Sheath body; 2. Main working channel; 3. Flushing microcatheter channel; 4. Pressure measuring microcatheter channel; 5. Single-function microcatheter channel; 6. Lateral suction connection port; 7. Flushing fluid connection port; 8. Pressure sensor connection port; 9. Switching valve; 10. Flexible ureteroscope; 11. Ureteral sheath base; 12. Water seal cap; 13. Adjustable channel; 14. Irrigation pump; 15. Pressure gauge. Detailed Implementation

[0027] The following is in conjunction with the appendix Figure 1-3 The present invention will be described in further detail below.

[0028] Example 1: A multi-lumen ureteral sheath system integrating flushing and pressure monitoring functions, such as Figure 1 As shown, the multi-lumen ureteral sheath system includes a sheath body 1 and a microcatheter channel. The microcatheter channel is integrated within the wall of the sheath body 1. The sheath body 1 has a main working channel 2 that runs through it, and the microcatheter channel extends parallel to the main working channel 2. A flexible ureteroscope 10 is inserted through the main working channel 2, and a lateral suction interface is provided at the proximal end of the main working channel 2 for connecting a negative pressure suction device. A ureteral sheath base 11 is connected to the proximal end of the sheath body 1, and a water seal cap 12 is connected to the proximal opening of the ureteral sheath base 11. The distal opening of the microcatheter channel is flush with or slightly retracted from the tip of the sheath body 1 to avoid interfering with the operation of the flexible ureteroscope 10 and to ensure the accuracy of pressure monitoring and irrigation.

[0029] When there are two microcatheter channels, the system is in dual-microcatheter mode. In dual-microcatheter mode, the sheath body 1 is provided with a flushing microcatheter channel 3 and a pressure measuring microcatheter channel 4. The proximal end of the flushing microcatheter channel 3 is connected to a flushing fluid connection port 7, and the distal end opens at the tip of the sheath body 1. The flushing fluid connection port 7 is connected to the infusion pump 14 through a pipe for infusing physiological saline into the renal pelvis. The proximal end of the pressure measuring microcatheter channel 4 is connected to a pressure sensor connection port 8, and the distal end opens at the tip of the sheath body 1. The pressure sensor connection port 8 is connected to a pressure gauge 15 for monitoring pressure.

[0030] During the procedure, the sheath body 1 is inserted into the ureter. While performing negative pressure suction, the irrigation fluid is simultaneously turned on and continuously irrigated into the renal pelvis at a low speed through the irrigation microcatheter channel 3. At the same time, the pressure is monitored in real time through the pressure-measuring microcatheter channel 4 to ensure that the pressure is within the safe range for the procedure to proceed.

[0031] Example 2: A multi-lumen ureteral sheath system integrating flushing and pressure monitoring functions, such as Figure 3 As shown, the multi-lumen ureteral sheath system includes a sheath body 1 and a microcatheter channel. The microcatheter channel is integrated within the wall of the sheath body 1. The sheath body 1 has a main working channel 2 that runs through it, and the microcatheter channel extends parallel to the main working channel 2. A flexible ureteroscope 10 is inserted through the main working channel 2, and a lateral suction interface is provided at the proximal end of the main working channel 2 for connecting a negative pressure suction device. A ureteral sheath base 11 is connected to the proximal end of the sheath body 1, and a water seal cap 12 is connected to the proximal opening of the ureteral sheath base 11. The distal opening of the microcatheter channel is flush with or slightly retracted from the tip of the sheath body 1 to avoid interfering with the operation of the flexible ureteroscope 10 and to ensure the accuracy of pressure monitoring and irrigation.

[0032] When the number of microcatheter channels is one, the system operates in single-microcatheter mode. In single-microcatheter mode, a single-function microcatheter channel 5 is located within the sheath body 1. A three-way switching valve 9 is located proximal to the single-function microcatheter channel 5. This valve can be selectively connected to an infusion pump 14 or a pressure gauge 15 to infuse saline solution into the renal pelvis or monitor pressure. During this process, the single-function microcatheter channel 5 is linked to the flexible ureteroscope 10, which has an adjustable channel 13. When performing lithotripsy, the flexible ureteroscope 10 is flushed, and the single-function microcatheter channel 5 of the ureteral sheath measures pressure. When performing negative pressure suction stone removal, the adjustable channel 13 connected to the flexible ureteroscope 10 is converted to a pressure measuring channel via the switching valve 9, while the microcatheter of the ureteral sheath becomes the water inlet channel, thus completing the functional switching at different stages.

[0033] In this embodiment, two functions are achieved through a single channel in a time-sharing manner. The structure is simpler and the cost is lower, making it suitable for surgical scenarios that are cost-sensitive or do not require continuous simultaneous flushing and pressure measurement.

[0034] This specific embodiment is merely an explanation of the present invention and is not intended to limit the invention. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they are within the scope of the claims of the present invention.

Claims

1. A multi-lumen ureteral sheath system integrating flushing and pressure monitoring functions, characterized in that: The multi-lumen ureteral sheath system includes a sheath body (1) and a microcatheter channel. The microcatheter channel is integrated into the wall of the sheath body (1). The sheath body (1) has a main working channel (2) that runs through it. The microcatheter channel extends in parallel with the main working channel (2). A ureteroscope (10) is inserted through the main working channel (2). A lateral suction interface is provided at the proximal end of the main working channel (2) for connecting a negative pressure suction device. A ureteral sheath base (11) is connected to the proximal end of the sheath body (1). A water seal cap (12) is connected to the proximal opening of the ureteral sheath base (11).

2. The multi-lumen ureteral sheath system integrating flushing and pressure monitoring functions according to claim 1, characterized in that: The distal opening of the microcatheter channel is flush with or slightly retracted from the tip of the sheath body (1), and the distal opening direction of the microcatheter channel includes, but is not limited to, forward, outward, and inward.

3. The multi-lumen ureteral sheath system integrating flushing and pressure monitoring functions according to claim 1, characterized in that: When there are two microcatheter channels, the system is in dual microcatheter mode. In dual microcatheter mode, the sheath body (1) is provided with a flushing microcatheter channel (3) and a pressure measuring microcatheter channel (4).

4. A multi-lumen ureteral sheath system integrating flushing and pressure monitoring functions according to claim 3, characterized in that: The proximal end of the flushing microcatheter channel (3) is connected to a flushing fluid connection port (7), and the distal end opens at the tip of the sheath body (1). The flushing fluid connection port (7) is connected to an infusion pump (14) through a pipe for infusing physiological saline into the renal pelvis / ureter. The pressure-measuring microcatheter channel (4) is connected to a pressure sensor port (8) at its proximal end and to the tip of the sheath body (1) at its distal end. The pressure sensor port (8) is connected to a pressure gauge (15) for monitoring pressure.

5. A multi-lumen ureteral sheath system integrating flushing and pressure monitoring functions according to claim 1, characterized in that: When the number of microcatheter channels is one, the system is in single microcatheter mode. In single microcatheter mode, a single-function microcatheter channel (5) is provided in the sheath body (1).

6. A multi-lumen ureteral sheath system integrating flushing and pressure monitoring functions according to claim 5, characterized in that: The single-function microcatheter channel (5) is provided with a three-way switching valve (9) at its proximal end. The three-way switching valve (9) can be selectively connected to an infusion pump (14) or a pressure gauge (15) to realize the function of infusing physiological saline into the renal pelvis or monitoring pressure.

7. A multi-lumen ureteral sheath system integrating flushing and pressure monitoring functions according to claim 5, characterized in that: The flexible ureteroscope (10) is provided with an adjustable channel (13).

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