Ureter leading-in sheath with real-time pressure monitoring capability

Abstract

The invention relates to the technical field of medical instruments, in particular to a ureter leading-in sheath with real-time pressure monitoring capability, which comprises a sheath tube and a sheath seat arranged at the near end of the sheath tube, the sheath seat is provided with a perfusion joint and a suction joint, and the sheath tube defines a channel for an instrument to pass through; the resistance detection piece is arranged on the sheath and is used for detecting the axial propelling resistance borne by the sheath tube when the sheath tube enters the human body cavity in real time and generating a resistance signal; the torque detection piece is arranged on the sheath and used for detecting the circumferential torque borne by the sheath tube when the sheath tube rotates in the human body cavity in real time and generating a torque signal; by arranging the detection system composed of the resistance detection piece, the torque detection piece and the pressure detection piece, objective operation guidance and over-limit early warning can be provided through real-time and quantitative force and pressure monitoring, and the risk of ureteral injury and renal pelvis high pressure related complications is greatly reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a ureteral induction sheath with real-time pressure monitoring capability, and particularly to an intelligent ureteral induction sheath and system capable of real-time monitoring of induction resistance, torque and intracavitary pressure. Background Technology

[0002] The ureteral guiding sheath is crucial in natural orifice urological surgeries (such as ureteroscopic lithotripsy), providing a stable passage for repeated insertion and removal of endoscopes and surgical instruments. The general anatomical route is: urethra → bladder → ureteral orifice → ureter → renal pelvis. The complex cavities of the human body present numerous challenges to sheath insertion. When passing through the external urethral sphincter region, involuntary sphincter contractions can generate 20-50 N of resistance if the patient is tense or anesthesia is insufficient. Furthermore, the male urethra exhibits a subpubic curvature (approximately 35°), making direct, forceful insertion prone to creating a false passage.

[0003] When the sheath passes through the ureteral orifice area, the normal orifice diameter in a normal adult male is 2-3 mm. In cases of stone impaction or inflammation, it may be <1.5 mm. The annular mucosal folds at the orifice form a natural barrier. When the sheath diameter is >4 mm, the passage rate decreases by 60%, and forced passage can easily lead to bleeding (clinical statistics show that damage here accounts for 38% of complications).

[0004] When the sheath passes through the ureteropelvic junction, the normal UPJ diameter is 4-6 mm, while in cases of congenital stenosis it may be <2 mm, and there is a downward tilt angle of the renal pelvis (approximately 30°-45°). The stenotic segment obstructs the return of perfusion fluid, and the intrarenal pelvis pressure may momentarily exceed 40 mmHg (exceeding the safe threshold of 30 mmHg). Currently, when inserting a sheath through a narrow, tortuous, or pathologically altered ureter, the procedure relies primarily on the physician's touch and experience to judge the resistance level. This subjective judgment is highly unreliable in complex situations, easily leading to serious complications such as ureteral mucosal damage, bleeding, or even perforation due to excessive pushing or torque. Furthermore, during sheath insertion, the intrarenal pelvic pressure can suddenly increase due to obstructed perfusion fluid return. Excessively high renal pelvic pressure (>30 mmHg) may lead to risks such as renal pelvic venous reflux and bacteremia, and existing devices lack effective real-time pressure monitoring methods. Summary of the Invention

[0005] In order to overcome the above-mentioned defects of the prior art, the present invention provides a ureteral sheath insertion system that can perform real-time quantitative monitoring and early warning of mechanical parameters (thrust, torque) and physiological parameters (intracavitary pressure) during the insertion process, so as to significantly improve the safety and controllability of the operation and solve the problems existing in the background art.

[0006] This invention provides the following technical solution: a ureteral intubation sheath with real-time pressure monitoring capability, comprising a sheath tube and a sheath seat disposed at the proximal end of the sheath tube, wherein the sheath seat is provided with an irrigation connector and a suction connector, the sheath tube defining a channel for the passage of instruments, and further comprising: A resistance detection element is installed on the sheath to detect the axial propulsion resistance encountered by the sheath tube when it enters the human body cavity in real time and generate a resistance signal. A torque detection element is installed on the sheath to detect the circumferential torque experienced by the sheath tube as it rotates within the human body cavity in real time and to generate a torque signal. Pressure detection device, used to detect fluid pressure in human body cavities in real time and generate pressure signals; The resistance detection element, torque detection element, and pressure detection element are adapted to communicate with an external controller to transmit the resistance signal, torque signal, and pressure signal to the controller for processing and display. Furthermore, the sheath also defines an independent pressure measuring channel extending from the proximal end to the distal end. The distal end of the pressure measuring channel is provided with at least one pressure measuring port communicating with the cavity, and the proximal end is provided with a pressure measuring interface connected to the pressure detection element.

[0007] Furthermore, the resistance detection element is an axial force sensor, and the torque detection element is a torque sensor, both integrated inside the sheath seat or in the proximal section of the sheath tube.

[0008] Furthermore, the infusion connector and the suction connector are integrated into a single infusion suction connector.

[0009] A ureteral inlet sheath system, comprising the aforementioned ureteral inlet sheath, and further comprising: The controller is communicatively connected to the resistance detection element, torque detection element, and pressure detection element of the ureteral induction sheath, and is used to receive and process the resistance signal, torque signal, and pressure signal. The display unit, connected to the controller, is used to display one or more of the resistance value, torque value, and pressure value in real time. An alarm unit, connected to the controller, is used to issue an alarm when the received resistance value, torque value, or pressure value reaches or exceeds a preset prompt threshold or warning threshold. The irrigation and suction device is connected to the irrigation and suction connectors of the ureteral inlet sheath via tubing.

[0010] Furthermore, the controller is preset with multiple sheath insertion modes corresponding to different cavity anatomical features. Each sheath insertion mode defines different resistance prompt thresholds, resistance warning thresholds, torque prompt thresholds, torque warning thresholds, pressure prompt thresholds, and pressure warning thresholds.

[0011] Furthermore, the selection of the sheath insertion mode is based on one or more of the following factors: cavity diameter, cavity curvature, tissue elasticity and toughness.

[0012] Furthermore, the alarm issued by the alarm unit is a multimodal alarm, including visual flashing signals of different colors and frequencies and / or audible buzzing signals.

[0013] Furthermore, the controller is also configured to control the infusion flow rate and / or suction pressure of the infusion aspiration device based on the real-time monitored pressure value and its changing trend, so as to maintain the pressure in the cavity within a preset safe range.

[0014] A method for safely inserting a ureteral sheath into a ureter, using the aforementioned ureteral sheath system and a ureteral insertion sheath with real-time pressure monitoring capability, includes the following steps: S1: Insert the ureteric guide sheath into the body cavity; S2: Set the prompt threshold and warning threshold for resistance, torque and pressure through the controller; S3: During the advancement and rotation of the sheath, the resistance value, torque value and renal pelvis pressure value are monitored in real time; S4: When any monitored value reaches its corresponding prompt threshold, the operator adjusts the propulsion force, twist angle and / or attempts to slightly withdraw the sheath and then re-enter it; S5: If the adjusted monitoring value continues to rise and reaches the warning threshold, stop the operation immediately and start the perfusion mode to expand the cavity or replace it with a smaller sheath.

[0015] The technical effects and advantages of this invention are as follows: 1. The present invention provides a detection system consisting of a resistance detection element, a torque detection element, and a pressure detection element. This system facilitates real-time and quantitative force and pressure monitoring, providing objective operational guidance and over-limit warnings, and greatly reduces the risk of ureteral injury and complications related to renal pelvis hypertension.

[0016] 2. The present invention, by incorporating a sheath insertion system, facilitates multimodal alarms and multiple preset sheath insertion modes, simplifies the surgeon's decision-making process in complex situations, and enhances adaptability to anatomical differences among different patients.

[0017] 3. The present invention, through the highly integrated distribution of resistance, torque and pressure detection elements on the sheath, facilitates the clever integration of sensors into the sheath seat or proximal end of the sheath tube, achieving the function without significantly increasing the size of the instrument, and without affecting its flexibility and passability.

[0018] 4. The present invention, by incorporating multiple preset sheathing modes and a multi-modal alarm unit in the controller, facilitates the formation of a closed-loop feedback between resistance / torque monitoring, pressure monitoring, and the injection system, laying the foundation for achieving semi-automated or intelligent safe sheathing operation. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the measurable force value ureteral sheath structure of the present invention.

[0020] Figure 2 This is a cross-sectional view of the measurable force value ureteral sheath structure of the present invention.

[0021] Figure 3 This is a schematic diagram of the sheath-feeding system of the present invention.

[0022] Figure 4 This is a schematic diagram of the insertion sheath structure of the present invention entering the bladder from the urethra.

[0023] Figure 5 This is a schematic diagram of the sheath insertion mechanism of the present invention entering the ureter from the ureteral opening.

[0024] Figure 6 This is a schematic diagram of the sheath insertion mechanism of the present invention entering the renal pelvis from the ureter.

[0025] The attached diagram is labeled as follows: 1. Sheath tube; 2. Sheath seat; 3. Injection and suction integrated connector; 4. Pressure measuring interface; 5. Resistance detection element; 6. Torque detection element; 7. Controller; 8. Display unit; 9. Alarm unit; 10. Pressure detection element. Detailed Implementation

[0026] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings. In addition, the forms of the various structures described in the following embodiments are merely illustrative. The ureteral induction sheath with real-time pressure monitoring capability involved in the present invention is not limited to the structures described in the following embodiments. All other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0027] Reference Figure 1 and Figure 2This invention provides a ureteral induction sheath with real-time pressure monitoring capability. The ureteral induction sheath consists of a sheath tube 1 and a sheath seat 2. The sheath tube 1 is made of a polymer composite material, which has good flexibility and biocompatibility. To optimize passage and reduce tissue damage, the material hardness of the distal portion of the sheath tube 1 (i.e., the portion that first enters the body) is lower than that of the proximal portion. As the optimal solution in this embodiment, the distal portion is made of thermoplastic polyurethane (TPU) with a Shore hardness of 55A-65A, and the proximal portion is made of polyamide or Pebax® material with higher hardness to ensure effective transmission of thrust. In this embodiment, it should be specifically noted that: the sheath seat 2 is fixedly connected to the proximal end of the sheath tube 1, and is usually made of engineering plastics such as ABS or PC. The sheath seat 2 is provided with an integrated infusion and suction connector 3, which can be used to connect the infusion fluid pipeline and the negative pressure suction pipeline, simplifying the external connection. The main difference between this embodiment and the prior art is that this embodiment adopts multiple monitoring methods to enable real-time quantitative monitoring and early warning of mechanical parameters (thrust, torque) and physiological parameters (intracavitary pressure) during the insertion process of the ureteral sheath system, so as to significantly improve the safety and controllability of the operation. Specifically, it uses resistance detection device 5, torque detection device 6 and pressure detection device 10. In some implementations, the sheathing system is configured with multiple sheathing modes, each with different resistance indication values, maximum warning resistance values, torque indication values, and high warning torque values. The appropriate sheathing mode is selected based on the diameter, curvature, and elastic toughness of the sheathing path.

[0028] In some embodiments, the intubation method includes a pressure control method within the cavity, which includes: adjusting the infusion and suction parameters based on the real-time monitored pressure value and the pressure value data change trend, so that the current intracavitary pressure is balanced at the pressure control value, thereby achieving a balanced state of infusion and suction. The infusion parameters include the infusion flow rate level, and the suction parameters include the opening of the pressure relief valve and the suction pressure threshold. The suction pressure threshold is a suction pressure threshold preset by the controller 7 for the suction container, and the start and stop of the suction pump are controlled by setting the suction pressure threshold.

[0029] In some embodiments, the sheath defines a pressure measuring channel extending from the proximal end toward the distal end, the distal end of the pressure measuring channel forming at least one pressure measuring port for sensing pressure within the cavity, and a pressure detection element 10 is provided on the pressure measuring channel or any path connected thereto.

[0030] In this embodiment, the resistance detection element 5 employs a miniature high-precision strain gauge force sensor (e.g., selectable from Honeywell or Futek product lines), with a range of 0-50N and an accuracy better than ±0.25% FS. This sensor is precision-mounted inside the sheath seat 2, aligned with the axial thrust direction of the sheath tube 1, and is used to accurately measure the axial resistance encountered when pushing the sheath tube. Its output signal is either an analog voltage or a digital signal.

[0031] In some embodiments, the sheath 2 is provided with a pressure measuring interface 4 that communicates with the pressure measuring channel, and the pressure measuring interface 4 is adapted to be connected to the pressure detection element 10.

[0032] In some implementations, if the inlet channel is a ureter with good elasticity and strong toughness, a high-resistance, high-torque inlet mode is selected; while for a ureter with poor elasticity, a low-resistance, low-torque inlet mode is selected.

[0033] In some implementations, if the sheath entry channel has a large bend, a low-resistance, low-torque sheath entry mode is selected; if the sheath entry channel has a small bend, a high-resistance, high-torque sheath entry mode is selected.

[0034] In this embodiment, the torque detection element 6 uses a non-contact torque sensor (e.g., based on magnetoelectric or photoelectric principles) with a range of 0-200 mN·m. This sensor is integrated on the rotating shaft of the sheath 1 and is used to accurately measure the circumferential torque experienced by the rotating sheath 1. It also outputs an electrical signal.

[0035] In some implementations, if the diameter of the sheath inlet channel is large, a high-resistance, high-torque sheath inlet mode is selected; if the sheath inlet channel is narrow, a low-resistance, low-torque sheath inlet mode is selected.

[0036] In this embodiment, both the resistance detection element 5 and the torque detection element 6 output their signals to an integrated electrical connector located on the sheath seat 2 via built-in shielded cables, and are ultimately connected to the external controller 7 via a single integrated wiring harness. The pressure signal is transmitted to the controller 7 via a pressure sensor cable connected to the pressure measurement interface 4.

[0037] Controller 7: This is the processing center of the system. It uses a 32-bit microprocessor based on the ARM Cortex-M core as the main control chip (MCU). Controller 7 internally includes: Multi-channel high-precision ADC module: used to acquire analog signals from force, torque, and pressure sensors.

[0038] Digital Signal Processing (DSP) Unit: Performs software filtering (such as using Kalman filtering or moving average algorithm) on the acquired raw signal to eliminate noise such as power frequency interference and operation jitter, and extracts stable and accurate measurement values.

[0039] Multiple pre-stored sheath insertion modes: The controller 7's memory stores pre-stored sheath insertion modes for different patient anatomical features, for example: Mode A (Standard Mode): Suitable for patients not expected to have significant stenosis or tortuosity. The resistance warning value is set to 15 N, the torque warning value is set to 100 mN·m, and the pressure warning value is set to 30 mmHg.

[0040] Mode B (Stenosis and High Curve Mode): Suitable for patients with UPJ stenosis or severe tortuosity shown on CT scans. More conservative parameters: resistance warning value set at 8 N, torque warning value set at 60 mN·m, and pressure warning value set at 25 mmHg.

[0041] In some embodiments, the resistance detection element 5 and torque detection element 6 may be additionally provided at the sheath seat 2. Working principle of the invention: A method for safely inserting a ureteral sheath system includes the following steps: S1: Insert the ureteric guide sheath into the body cavity; S2: Set the prompt threshold and warning threshold for resistance, torque and pressure through the controller 7; S3: During the advancement and rotation of the sheath 1, the resistance value, torque value and renal pelvis pressure value are monitored in real time; S4: When any monitored value reaches its corresponding prompt threshold, the operator adjusts the propulsion force, twist angle and / or attempts to slightly withdraw the sheath and then re-enter it; S5: If the monitored value continues to rise after adjustment and reaches the warning threshold, stop the operation immediately and start the infusion mode to expand the cavity or replace it with a smaller sheath 1. If the sheath insertion resistance and maximum torque decrease after expanding the cavity, continue pushing / twisting the sheath 1. This situation indicates that the high sheath insertion resistance / torque is caused by the narrowness of the cavity. If the cavity pressure reaches the maximum warning pressure value after expanding the cavity by infusing liquid, and either the sheath insertion resistance or torque still exceeds the warning value, it proves that the volume of the cavity expansion by infusion is limited, and the sheath 1 is still difficult to move forward / rotate. At this time, consider replacing it with a smaller sheath. When pushing the smaller sheath into the cavity, repeat the pushing method of the above steps. If the sheath insertion resistance / torque of the smaller sheath still exceeds the warning value, it is determined that the cavity is blocked.

[0042] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A ureteral intubation sheath with real-time pressure monitoring capability, comprising a sheath tube (1) and a sheath seat (2) disposed at the proximal end of the sheath tube (1), wherein the sheath seat (2) is provided with an irrigation connector and a suction connector, and the sheath tube (1) defines a channel for the passage of an instrument, characterized in that, Also includes: A resistance detection element (5) is installed on the sheath to detect the axial propulsion resistance encountered by the sheath tube (1) when it enters the human body cavity in real time and generate a resistance signal. A torque detection element (6) is installed on the sheath to detect the circumferential torque experienced by the sheath tube (1) when it rotates in the human body cavity in real time and generate a torque signal. Pressure detection element (10) is used to detect the fluid pressure in the human body cavity in real time and generate a pressure signal; The resistance detection element (5), torque detection element (6) and pressure detection element (10) are adapted to communicate with an external controller (7) to transmit the resistance signal, torque signal and pressure signal to the controller (7) for processing and display.

2. The ureteral induction sheath with real-time pressure monitoring capability according to claim 1, characterized in that: The sheath (1) is further defined with an independent pressure measuring channel extending from the proximal end to the distal end. The distal end of the pressure measuring channel is provided with at least one pressure measuring port communicating with the cavity, and the proximal end is provided with a pressure measuring interface (4) connected to the pressure detection element (10).

3. The ureteral induction sheath with real-time pressure monitoring capability according to claim 2, characterized in that: The resistance detection element (5) is an axial force sensor, and the torque detection element (6) is a torque sensor. The two are integrated inside the sheath seat (2) or the proximal section of the sheath tube (1).

4. A ureteral induction sheath with real-time pressure monitoring capability according to claim 3, characterized in that: The injection connector and the suction connector are integrated into a single injection and suction connector.

5. A ureteral inlet sheath system, comprising a ureteral inlet sheath with real-time pressure monitoring capability as described in any one of claims 4, characterized in that, Also includes: The controller (7) is communicatively connected to the resistance detection device (5), torque detection device (6) and pressure detection device (10) of the ureteral inlet sheath, and is used to receive and process the resistance signal, torque signal and pressure signal; The display unit (8) is connected to the controller (7) and is used to display one or more of the resistance value, torque value and pressure value in real time; An alarm unit (9) is connected to the controller (7) and is used to issue an alarm when the received resistance value, torque value or pressure value reaches or exceeds a preset prompt threshold or warning threshold. The irrigation and suction device is connected to the irrigation and suction connectors of the ureteral inlet sheath via tubing.

6. A ureteral sheath insertion system according to claim 5, characterized in that: The controller (7) has multiple sheath insertion modes corresponding to different cavity anatomical features. Each sheath insertion mode defines different resistance prompt thresholds, resistance warning thresholds, torque prompt thresholds, torque warning thresholds, pressure prompt thresholds, and pressure warning thresholds.

7. A ureteral sheath insertion system according to claim 6, characterized in that: The selection of the sheath insertion mode is based on one or more of the following factors: cavity diameter, cavity curvature, tissue elasticity and toughness.

8. A ureteral sheath insertion system according to claim 7, characterized in that: The alarm issued by the alarm unit (9) is a multimodal alarm, including visual flashing signals of different colors and frequencies and / or auditory buzzing signals.

9. A ureteral sheath insertion system according to claim 8, characterized in that: The controller (7) is also configured to control the infusion flow rate and / or suction pressure of the infusion aspiration device based on the real-time monitored pressure value and its changing trend, so as to maintain the pressure in the cavity within a preset safe range.

10. A method for safely inserting a ureteral sheath into a ureteral sheath system, using a ureteral sheath system as described in any one of claims 9, characterized in that, Includes the following steps: S1: Insert the ureteric guide sheath into the body cavity; S2: Set the prompt threshold and warning threshold for resistance, torque and pressure through the controller (7); S3: During the advancement and rotation of the sheath (1), the resistance value, torque value and renal pelvis pressure value are monitored in real time; S4: When any monitored value reaches its corresponding prompt threshold, the operator adjusts the propulsion force, twist angle and / or attempts to slightly withdraw the sheath and then re-enter it; S5: If the monitored value continues to rise after adjustment and reaches the warning threshold, stop the operation immediately and start the perfusion mode to expand the cavity or replace it with a smaller sheath (1).

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