Ureter guiding sheath device for monitoring internal pressure of pelvis in real time

Abstract

The invention discloses a ureter guiding sheath device for monitoring internal pressure of a renal pelvis in real time, which relates to the technical field of medical instruments and comprises a guiding sheath, a dilator, a pressure gauge and a negative pressure drainage bottle. Instant and continuous pressure monitoring is achieved through the built-in pressure sensor, and the operation efficiency is improved. The independent pressure measuring channel effectively isolates potential interference of negative pressure suction equipment to pelvis pressure monitoring, meanwhile, due to the design of the far-end closed structure of the pressure measuring channel and the pressure measuring hole, extrusion to the pressure measuring channel when the endoscope is bent is effectively avoided, and the accuracy of monitoring data is ensured. The pressure gauge is provided with the pre-filling shell composed of the gas-liquid separation filter element, the gas-liquid separation filter element only allows gas to pass through and liquid to be left in the pressure gauge, it is effectively guaranteed that the pressure sensor from the pressure measuring channel to the pressure gauge is filled with the liquid in the pelvis, interference of residual gas is avoided, and the accuracy of pressure measurement is guaranteed.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a ureteral guide sheath device for real-time monitoring of renal pelvic intra-pressure. Background Art

[0002] In urological surgery, in order to prevent complications such as fever and renal pelvic rupture caused by changes in intra-renal pelvic pressure, it is very important to accurately monitor and control the intra-renal pelvic pressure during surgery. However, traditional methods have significant inconvenience and inefficiency in measuring intra-renal pelvic pressure. Specifically, the doctor needs to first remove the endoscope, guide wire and other equipment in the ureteral sheath, and then insert the pressure measuring tube, which increases the complexity and time of the operation, affects the smoothness of the operation, and may increase the patient's risk and recovery time.

[0003] Currently, the ureteral pressure measurement guide sheath devices on the market are as follows Figure 1 and Figure 6 As shown, it includes a guide sheath 1, a dilator 2 and a negative pressure drainage bottle 4. The guide sheath 1 is composed of a sheath tube 101, a sheath tube seat 102, a sealing plug 103 and a gland 104. A pressure measuring cavity 105 and a sheath tube main cavity 106 are arranged in the sheath tube. The outer surface of the sheath tube 101 is covered with a hydrophilic coating, wherein the sheath tube seat 102 is composed of a negative pressure suction joint 1021, a main cavity tube seat 1022 and a pressure measuring joint 1023. A negative pressure regulating switch is arranged on the negative pressure suction joint 1021. The pressure measuring joint 1023 can be connected to a pressure measuring device through a catheter for pressure measurement. The negative pressure suction joint 1021 is connected to the stone outflow tube 405 of the negative pressure drainage bottle 4, and the negative pressure suction tube 406 is connected to the negative pressure suction device for stone removal. The design of the ureteral pressure measuring guide sheath allows direct pressure measurement without removing the endoscope, guide wire and other instruments in the ureteral sheath, which significantly improves the efficiency of the operation. However, in clinical application tests, when the endoscope causes the sheath 101 to bend, the pressure measuring cavity 105 is easily compressed, resulting in inaccurate pressure monitoring results. In addition, when performing the pressure measurement operation, it is necessary to connect the negative pressure suction device and the pressure measuring device at the same time. This process is relatively complicated, which limits the doctor's operating space and brings inconvenience to the operation.

[0004] CN 220070427 U discloses a flexible pressure measuring sheath, which is characterized in that it is connected to a pressure detection joint through a pressure measuring tube seat and uses a liquid pressure measuring mechanism to achieve pressure measurement. However, the disadvantage of this innovative design is that its pressure measuring channel, instrument channel and negative pressure suction channel share the same lumen. This design will cause the pressure generated by negative pressure suction to interfere with the pressure measurement result when performing pressure detection.

[0005] CN 219539185 U discloses a three-cavity ureteral sheath with a pressure measuring function. By arranging a pressure sensor in the pressure measuring channel, the pressure condition in the patient's pelvis can be monitored in real time. However, the outlets of the new stone pressure measuring channel, the water flow channel and the instrument channel extend to the head end of the ureteral sheath. During clinical use, when the distal end of the ureteral sheath is passively bent, the pressure measuring channel and the water flow channel are easily squeezed, thereby reducing the accuracy of pressure detection.

[0006] Therefore, there is an urgent need for a ureteral guide sheath that combines accurate pressure measurement with easy operation and can monitor the intra-renal pelvic pressure in real time, so as to better serve the diagnosis and treatment of patients with urinary system diseases. Summary of the invention

[0007] In order to solve the above problems, the present invention proposes a ureteral guide sheath that can monitor the intrarenal pelvic pressure in real time, which has accurate pressure measurement, simple operation and real-time monitoring.

[0008] The specific technical scheme of the present invention is as follows: A ureteral guide sheath device for real-time monitoring of renal pelvic pressure comprises a guide sheath, a dilator and a negative pressure drainage bottle, the guide sheath is composed of a sheath tube, a sheath tube seat, a sealing plug and a pressure cover, a pressure measuring cavity and a sheath tube main cavity are arranged in the sheath tube, the sheath tube seat is composed of a negative pressure suction joint, a main cavity tube seat and a pressure measuring joint, the negative pressure suction joint is provided with a first negative pressure regulating switch, the pressure measuring cavity is a blind tube with one end closed at the tail, a pressure measuring hole communicating with the pressure measuring cavity is arranged on the distal side wall of the sheath tube, a pressure gauge assembly is connected to the pressure measuring joint, the pressure gauge assembly comprises a pressure gauge, a pressure measuring connecting pipe and a pressure measuring connecting pipe seat connected to the pressure measuring joint, an exhaust hole is opened on the side wall of the pressure measuring connecting joint base on the pressure gauge, an air exhaust hole is installed in the exhaust hole, the air-liquid separation filter element is a through three-dimensional porous structure, and the air-liquid separation filter element is combined with the exhaust hole in a tight fit manner.

[0009] The distance between the end of the pressure measuring cavity and the head end of the sheath tube is 50-200 mm, and the distance between the pressure measuring hole and the head end of the sheath tube is 50-100 mm.

[0010] The inner diameter of the pressure gauge pressure measuring connection joint base is 4.0-9.4mm, the outer diameter is 12.0-18.0mm, the inner diameter of the exhaust hole is 0.9-9.3mm, the gas-liquid separation filter element is a porous structure with a pore diameter of 0.1-10μm, an outer diameter of 1.0-9.4mm, and a thickness of 2.0-12.0mm. The material is one of polyethylene and polytetrafluoroethylene.

[0011] The pressure gauge pressure measuring connection joint base is connected with a 6% Luer inner cone joint.

[0012] The pressure gauge can display two pressure units: mmHg or cmH2O.

[0013] The expander consists of an expander tube seat and a expander tube body.

[0014] The negative pressure drainage bottle is composed of a bottle body, a bottle cap, a stone filter, a second negative pressure regulating switch, a stone outflow tube and a negative pressure suction tube.

[0015] The sheath tube is a passive flexible sheath, consisting of an inner lining, a support layer and a sheath layer. The inner lining material is one or more of Teflon, silicone, polyvinyl chloride, polyethylene or nylon, the support layer material is one or more of SUS304, SUS316 or SUS316L, the sheath layer material is one or more of polyethylene, polyvinyl chloride, polyetheramide or nylon, and the hardness is 25D-80D.

[0016] The outer surface of the sheath layer is covered with a hydrophilic coating, and the material of the hydrophilic coating is one or more of polyvinyl pyrrolidone, polyacrylic acid, inorganic siloxane and fluorocarbon.

[0017] The beneficial effects of the present invention are as follows: the present invention innovatively utilizes the direct impact of the liquid in the renal pelvis on the pressure sensor in the pressure gauge to realize the instant and continuous monitoring of the pressure in the renal pelvis, thereby simplifying the surgical process and avoiding the cumbersome steps of doctors frequently withdrawing medical equipment to measure pressure during surgery. The passive bending design of the guide sheath of the present invention allows it to bend with the bending of the endoscope, ensuring that the device can flexibly adapt to the complex ureter and kidney structure. Further, the present invention is designed with an independent pressure measurement channel, which effectively isolates the potential interference of the negative pressure suction device on the renal pelvic pressure monitoring. At the same time, the design of the distal closed structure of the pressure measurement channel and the pressure measurement hole effectively avoids the squeezing of the pressure measurement channel when the endoscope is bent, ensuring the accuracy of the monitoring data. At the same time, the independent negative pressure suction connector design also avoids the mutual interference between the endoscope and the negative pressure suction system, making the surgical operation smoother. In addition, the pressure gauge is provided with a gas-liquid separation filter element, which adopts a high-throughput three-dimensional porous structure. The material of the filter element will quickly absorb water and expand, thereby closing the pore size inside it. Based on this principle, when performing the pre-filling and washing steps of the pressure gauge, the operator will pre-fill with saline to promote the discharge of residual air inside the pressure gauge. With the continuous injection of saline, the gas-liquid separation filter element begins to gradually absorb water and expand until its porous structure is completely closed. This process effectively prevents any gas molecules from entering the pressure gauge again, avoiding the interference of residual gas on the pressure measurement results, thereby greatly improving the accuracy of liquid pressure measurement. It effectively ensures that the pressure sensor from the pressure measurement channel to the pressure gauge is filled with liquid, avoiding the interference of residual gas, and ensuring the accuracy of liquid pressure measurement. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a structural diagram of a ureteral pressure measurement guide sheath device in the prior art;

[0019] Figure 2 This is a structural diagram of a ureteral guide sheath device for real-time monitoring of renal pelvic pressure of the present invention;

[0020] Figure 3 It is a structural diagram of the introducer sheath dilator of the present invention;

[0021] Figure 4 This is the structural diagram of the pressure gauge assembly;

[0022] Figure 5 It is the side view of the pressure gauge;

[0023] Figure 6 It is the cross-sectional view of the pressure gauge;

[0024] Figure 7 This is a structural diagram of a negative pressure drainage bottle;

[0025] Figure 8 It is a cross-sectional view of the sheath tube of the present invention. DETAILED DESCRIPTION

[0026] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings. It should be understood that the specific implementation methods described herein are only used to explain the present invention and are not used to limit the present invention.

[0027] In the description of the present invention, it should be noted that the orientations or positional relationships indicated by terms such as “upper”, “middle”, “lower”, “inside”, “outside”, and “both sides” are based on the orientations or positional relationships shown in the accompanying drawings, and are only simplified descriptions for the convenience of describing the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0028] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "provided with", "connected", etc. should be understood in a broad sense. For example, "connected" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0029] Reference Figure 2-Figure 8 As shown, the ureteral guide sheath capable of real-time monitoring of the renal pelvic pressure of the present invention comprises a guide sheath 1, a dilator 2, a pressure gauge assembly 3 and a negative pressure drainage bottle 4.

[0030] The guide sheath is composed of a sheath tube 101, a sheath tube seat 102, a sealing plug 103 and a pressure cover 104. A pressure measuring cavity 105 and a sheath tube main cavity 106 are provided in the sheath tube. A pressure measuring hole 107 is provided on the distal side wall of the sheath tube. The pressure measuring cavity is a closed lumen. The distance between the end of the pressure measuring cavity and the head end of the sheath tube 101 is 50-200mm, and the distance between the pressure measuring hole and the head end of the sheath tube 101 is 50-100mm. The sheath tube seat 102 is composed of a negative pressure suction joint 1021, a main cavity tube seat 1022 and a pressure measuring joint 1023. The negative pressure suction joint is provided with a negative pressure regulating switch. The sheath tube 101 is a passive bendable sheath, which is composed of an inner lining 1011, a support layer 1012 and a sheath layer 1013. The inner lining material is one or more of Teflon, silicone, polyvinyl chloride, polyethylene or nylon, the support layer material is one or more of SUS304, SUS316 or SUS316L, and the sheath layer material is one or more of polyethylene, polyvinyl chloride, polyetheramide or nylon, with a hardness of 25D-80D. The outer surface of the sheath layer 1013 is covered with a hydrophilic coating, and the hydrophilic coating material is one or more of polyvinyl pyrrolidone, polyacrylic acid, inorganic siloxane and fluorocarbon.

[0031] The dilator is composed of a dilator tube seat 201 and a dilator tube body 202 .

[0032] The pressure gauge assembly 3 includes a pressure gauge 301, a pressure measuring connection pipe 302, and a pressure measuring connection pipe seat 303 connected to the pressure measuring joint 1023. The side wall of the pressure measuring connection joint base 3013 on the pressure gauge 301 is provided with an exhaust hole, and a gas-liquid separation filter element 3016 is installed in the exhaust hole. The gas-liquid separation filter element 3016 is a through three-dimensional porous structure, and the gas-liquid separation filter element and the exhaust hole are combined in a tight fit. The inner diameter of the pressure gauge pressure measuring connection joint base 3013 is 4.0-9.4mm, the outer diameter is 12.0-18.0mm, the inner diameter of the exhaust hole is 0.9-9.3mm, the gas-liquid separation filter element is a porous structure, the pore diameter is 0.1-10μm, the outer diameter is 1.0-9.4mm, the thickness is 2.0-12.0mm, and the material is one of polyethylene and polytetrafluoroethylene. The pressure gauge pressure measuring connection joint base 3013 is connected with a 6% Luer inner cone joint 3011. The gas-liquid separation filter element in the present invention is purchased from Shenzhen Comma Biotechnology Co., Ltd.

[0033] The pressure gauge 301 can display two pressure units: mmHg or cmH2O.

[0034] The negative pressure drainage bottle is composed of a bottle body 401 , a bottle cap 402 , a stone filter 403 , a negative pressure regulating switch 404 , a stone outflow tube 405 and a negative pressure suction tube 406 .

[0035] Fill the syringe with saline and connect it to the pressure measuring connection joint 303. Through this connection, slowly inject saline into the pressure measuring connection pipe 302 to ensure that the air inside the pipe is completely exhausted. The air will overflow along the gas-liquid separation filter element in the pressure measuring connection joint 3013 of the pressure gauge until the entire system is filled with saline, which ensures that there is no air bubble interference in front of the pressure sensor in the pressure gauge 301, thereby obtaining a more accurate pressure reading.

[0036] Next, using the same method, the pressure measuring cavity 105 is also filled with physiological saline through the pressure measuring hole 107 until it is confirmed that there are no bubbles. This process is to ensure that each part of the pressure measuring system is in the best condition to reduce measurement errors.

[0037] After completing the above preparations, the pressure measuring connector 303 is connected to the pressure measuring connector 1023. At this point, it should be noted that the use of physiological saline is not only for filling the system, but also for activating the hydrophilic coating on the sheath layer 1013, which helps to reduce the friction of the guide sheath in the body, making it easier to insert and reach the target position.

[0038] Subsequently, under the guidance of the guide wire, the dilator tube body 202 smoothly inserts the ureteral guide sheath, which can monitor the renal pelvic pressure in real time, into the ureter until it reaches the renal calyx. During this process, the design of the guide sheath allows it to bend with the bending of the endoscope, ensuring that the device can flexibly adapt to the complex ureteral and kidney structures.

[0039] In order to further support the surgical operation, it is also necessary to connect the negative pressure suction connector 1021 to the stone outflow tube 405, and connect the negative pressure suction tube 406 to the negative pressure suction device. After the dilator 2 is taken out, the doctor can insert the endoscope through the main cavity tube seat 1022 and connect the perfusion device to the endoscope. After starting the perfusion device and the negative pressure suction device, turning on the pressure gauge switch can display the pressure changes in the renal pelvis in real time.

[0040] Finally, according to actual needs, the doctor can adjust the required negative pressure level (the unit can be mmHg or cmH2O) through the negative pressure adjustment switch 404 to optimize the surgical conditions. During the whole process, the sheath 101 can bend with the movement of the endoscope to ensure that the endoscope can accurately reach and treat the stones in the renal calyx.

[0041] This design not only improves the safety and efficiency of the operation, but also provides doctors with real-time intra-renal pelvic pressure data, helping to better control risks during the operation.

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

Claims

1. A ureteral guide sheath device for real-time monitoring of renal pelvic pressure, comprising a guide sheath (1), a dilator (2) and a negative pressure drainage bottle (4), wherein the guide sheath (1) is composed of a sheath tube (101), a sheath tube seat (102), a sealing plug (103) and a gland (104), wherein a pressure measuring cavity (105) and a sheath tube main cavity (106) are arranged in the sheath tube, and the sheath tube seat (102) is composed of a negative pressure suction joint (1021), a main cavity tube seat (1022) and a pressure measuring joint (1023), and the negative pressure suction joint (1021) is provided with a first negative pressure regulating switch, characterized in that: The pressure measuring cavity (105) is a blind tube with one end of the tail portion closed. The distal side wall of the sheath tube (101) is provided with a pressure measuring hole (107) communicating with the pressure measuring cavity (105). The pressure measuring joint (1023) is connected to a pressure gauge assembly (3). The pressure gauge assembly (3) comprises a pressure gauge (301), a pressure measuring connecting pipe (302) and a pressure measuring connecting pipe seat (303) connected to the pressure measuring joint (1023). The side wall of the pressure measuring connecting joint base (3013) on the pressure gauge (301) is provided with an exhaust hole. A gas-liquid separation filter element (3016) is installed in the exhaust hole. The gas-liquid separation filter element (3016) is a through three-dimensional porous structure. The gas-liquid separation filter element and the exhaust hole are combined in a tight fit manner.

2. The ureteral guide sheath device for real-time monitoring of renal pelvic pressure according to claim 1, characterized in that: The distance between the end of the pressure measuring cavity (105) and the head end of the sheath tube (101) is 50-200 mm, and the distance between the pressure measuring hole (107) and the head end of the sheath tube (101) is 50-100 mm.

3. The ureteral guide sheath device for real-time monitoring of renal pelvic pressure according to claim 1, characterized in that: The inner diameter of the pressure gauge pressure measuring connection joint base (3013) is 4.0-9.4 mm, the outer diameter is 12.0-18.0 mm, the inner diameter of the exhaust hole is 0.9-9.3 mm, the gas-liquid separation filter element is a porous structure with a pore diameter of 0.1-10 μm, an outer diameter of 1.0-9.4 mm, and a thickness of 2.0-12.0 mm. The material is one of polyethylene and polytetrafluoroethylene.

4. The ureteral guide sheath device for real-time monitoring of renal pelvic pressure according to claim 1, characterized in that: The pressure gauge pressure measuring connection joint base (3013) is connected to a 6% Luer inner cone joint (3011).

5. The ureteral guide sheath device for real-time monitoring of renal pelvic pressure according to claim 1, characterized in that: The pressure gauge (301) can display two pressure units: mmHg or cmH2O.

6. The ureteral guide sheath device for real-time monitoring of renal pelvic pressure according to claim 1, characterized in that: The dilator (2) consists of a dilator tube seat (201) and a dilator tube body (202).

7. The ureteral guide sheath device for real-time monitoring of renal pelvic pressure according to claim 1, characterized in that: The negative pressure drainage bottle (4) is composed of a bottle body (401), a bottle cap (402), a stone filter (403), a second negative pressure regulating switch (404), a stone outflow tube (405) and a negative pressure suction tube (406).

8. The ureteral guide sheath device for real-time monitoring of renal pelvic pressure according to claim 1, characterized in that: The sheath tube (101) is a passive bendable sheath, which is composed of an inner lining (1011), a support layer (1012) and a jacket layer (1013). The inner lining is made of one or more of Teflon, silicone, polyvinyl chloride, polyethylene or nylon. The support layer is made of one or more of SUS304, SUS316 or SUS316L. The jacket layer is made of one or more of polyethylene, polyvinyl chloride, polyetheramide or nylon, and has a hardness of 25D-80D.

9. The ureteral guide sheath device for real-time monitoring of renal pelvic pressure according to claim 8, characterized in that: The outer surface of the sheath layer is covered with a hydrophilic coating, and the material of the hydrophilic coating is one or more of polyvinyl pyrrolidone, polyacrylic acid, inorganic siloxane and fluorocarbon.

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