Percutaneous liver puncture biliary drainage auxiliary device for tumor clinical interventional therapy

By designing a clamping protection mechanism and a complication monitoring component, the percutaneous hepatic biliary drainage auxiliary device for interventional tumor treatment solves the problems of poor protection and insufficient monitoring of existing devices, and realizes real-time monitoring of the drainage tube and safe and efficient care for patients.

CN121868599APending Publication Date: 2026-04-17SHIJIAZHUANG PEOPLES HOSPITAL
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
SHIJIAZHUANG PEOPLES HOSPITAL
Filing Date
2025-12-22
Publication Date
2026-04-17

AI Technical Summary

Technical Problem

Existing percutaneous hepatic biliary drainage auxiliary devices have poor protection of the drainage tube and insufficient ability to monitor the risk of complications, making it difficult to achieve real-time monitoring and early warning.

Method used

A percutaneous liver puncture biliary drainage auxiliary device for clinical interventional treatment of tumors was designed, which includes a clamping and protection mechanism, a complication monitoring component and a restraint strap component. It utilizes a temperature sensor and an ultrasonic flow sensor to achieve real-time monitoring, and improves comfort and fixation effect through Velcro and ventilation hole design.

Benefits of technology

It achieves multi-directional fixation and protection of the drainage tube, real-time monitoring of patient body temperature and bile flow rate, reduces the risk of complications, improves postoperative comfort and safety for patients, and reduces the operational difficulty for medical staff.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention discloses a tumor clinical interventional therapy percutaneous liver puncture biliary drainage auxiliary device, comprising: a clamping protection mechanism comprising a clamping frame assembly and a gooseneck assembly which is arranged on the clamping frame assembly and can be adjusted in position along the vertical direction; the complication monitoring assembly comprises a monitoring host installed on the clamping frame assembly, and a temperature sensor and an ultrasonic flow sensor which are electrically connected with the monitoring host; the temperature sensor is used for monitoring the body temperature of a patient in real time, and the ultrasonic flow sensor is connected with the drainage tube and used for achieving non-invasive monitoring of the bile flow velocity; the binding belt assembly is used for being fixed to the waist and abdomen of a patient in a surrounding mode, and the binding belt assembly is provided with a first through hole used for a drainage tube to pass through and a second through hole used for a temperature probe of a temperature sensor to pass through; the problems that an existing percutaneous liver puncture biliary tract drainage auxiliary device is poor in drainage tube protection effect and insufficient in complication risk monitoring capacity are solved.
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Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an auxiliary device for percutaneous liver puncture and biliary drainage in clinical interventional treatment of tumors. Background Technology

[0002] Percutaneous transhepatic biliary drainage (PTCD) is a core technique for relieving biliary obstruction in interventional oncology. Its therapeutic effect and postoperative recovery quality are highly dependent on the effectiveness of supporting auxiliary methods. However, the auxiliary devices currently used throughout the PTCD procedure are mostly drainage tube fixation devices. These devices have simple functions, only providing basic drainage tube fixation, and have significant shortcomings in drainage tube protection and complication risk monitoring. Specific problems are as follows:

[0003] Firstly, existing auxiliary devices for fixing drainage tubes mainly fall into two categories: one is auxiliary support structures, such as external supports made of metal or plastic, which fix the drainage tube to a surface support using clips; the other is abdominal wrap-like methods, such as elastic abdominal binders, which press the drainage tube onto the skin surface through pressure around the abdomen. In addition, there are basic methods such as adhesive tape and simple clips for fixation. All these fixation methods leave most of the drainage tube exposed, resulting in poor protection for the tube.

[0004] Secondly, the lack of auxiliary means for monitoring complications during the postoperative care stage makes it difficult to achieve timely monitoring and early warning of risks. Common complications after PTCD include drainage tube blockage and biliary tract inflammation. Current monitoring relies on "manual periodic inspections." For drainage tube blockage, nursing staff need to observe the drainage volume every 4-6 hours to determine patency, which cannot achieve real-time monitoring. For biliary tract inflammation, nursing staff need to check the patient's temperature every 4-6 hours, or when the patient develops obvious fever and abdominal pain. However, checking the patient's temperature every 4-6 hours cannot achieve real-time temperature monitoring and has a certain lag; by the time the patient develops obvious fever and abdominal pain, the infection has already progressed to the middle or late stage.

[0005] In order to address the aforementioned problems with existing percutaneous hepatic biliary drainage auxiliary devices, the applicant proposes a novel percutaneous hepatic biliary drainage auxiliary device for interventional tumor treatment. Summary of the Invention

[0006] The purpose of this invention is to provide an auxiliary device for percutaneous hepatic biliary drainage in clinical interventional treatment of tumors, which aims to improve the problems of poor protection of the drainage tube and insufficient monitoring of complication risks in existing percutaneous hepatic biliary drainage auxiliary devices.

[0007] This invention is implemented as follows:

[0008] A percutaneous transhepatic biliary drainage support device for interventional tumor treatment includes:

[0009] The clamping protection mechanism includes a clamping frame assembly and a gooseneck tube assembly disposed on the clamping frame assembly and adjustable in position along the vertical direction;

[0010] The complication monitoring component includes a monitoring host mounted on a clamping assembly, a temperature sensor electrically connected to the monitoring host, and an ultrasonic flow sensor; the temperature sensor is used to monitor the patient's body temperature in real time, and the ultrasonic flow sensor is connected to a drainage tube to achieve non-invasive monitoring of bile flow rate;

[0011] A restraint assembly for wrapping and securing around the patient's waist and abdomen, the restraint assembly having a first through hole for a drainage tube to pass through and a second through hole for a temperature probe of a temperature sensor to pass through.

[0012] Furthermore, the clamping frame assembly includes an inverted bracket and a guide rod vertically arranged on the inverted bracket, and the gooseneck tube assembly is arranged on the guide rod; a first threaded through hole is provided on the bottom wall of the inverted bracket, and a fastening bolt is threadedly installed in the first threaded through hole, and a clamping plate is detachably installed on the top end of the shank of the fastening bolt.

[0013] Furthermore, the gooseneck tube assembly includes a sleeve and a gooseneck tube, the gooseneck tube being connected to the sleeve; the sleeve is fitted onto a guide rod and can slide up and down along the guide rod, the sleeve has a second threaded through hole leading to the inside of the tube on its wall, and an adjusting bolt is threaded into the second threaded through hole.

[0014] Furthermore, an inclined installation pipe is connected to the wall of the sleeve pipe, the gooseneck tube is installed in the installation pipe, and the installation pipe is provided with a fixing structure for fixing the gooseneck tube.

[0015] Furthermore, the monitoring host and the C-shaped frame are connected by an L-shaped connecting rod; each end of the L-shaped connecting rod is provided with a connecting plate, and the two connecting plates are respectively connected to the housing wall of the monitoring host and the vertical wall of the C-shaped frame by bolts, and hooks are installed on the housing wall of the monitoring host.

[0016] Furthermore, the restraint strap assembly includes a fixing strap, an upper connecting strap, and a lower connecting strap, with the first through hole and the second through hole disposed on the fixing strap; both ends of the fixing strap are detachably connected to the upper connecting strap and the lower connecting strap, respectively, and the ends of the upper connecting strap and the lower connecting strap away from the fixing strap are detachably connected.

[0017] Furthermore, the two ends of the fixing strap are respectively provided with a first hook and loop fastener and a second hook and loop fastener; the upper connecting strap is provided with a third hook and loop fastener at one end connected to the fixing strap, and a fourth hook and loop fastener at the other end; the lower connecting strap is provided with a fifth hook and loop fastener at one end connected to the fixing strap, and a sixth hook and loop fastener at the other end; the third hook and loop fastener and the fifth hook and loop fastener are respectively adapted and connected to the first hook and loop fastener and the second hook and loop fastener, and the fourth hook and loop fastener and the sixth hook and loop fastener are adapted and connected.

[0018] Furthermore, two adhesive strips are provided on the fixing strip at a distance from each other along its length, and release paper is provided on the bonding surface of the adhesive strips. The first through hole and the second through hole are located between the two adhesive strips.

[0019] Furthermore, the adhesive tape is provided with a first group of vent holes, and the fixing strip is provided with a second group of vent holes corresponding to the positions of the two adhesive tapes, with each vent hole of the second group of vent holes aligned with each vent hole of the first group of vent holes.

[0020] Furthermore, the monitoring host includes a control module, a display screen on its front wall, an alarm at its top, and sensor connection ports. The temperature sensor and ultrasonic flow sensor are connected to their respective sensor connection ports. The display screen, alarm, and sensor connection ports are all electrically connected to the control module. The ultrasonic flow sensor has a clamp-type sensor probe, which integrates two symmetrically arranged ultrasonic transducers and a temperature detection element. The clamp-type sensor probe has a clamping groove adapted to the drainage tube. When the clamp-type sensor probe clamps the drainage tube, the inner wall of the clamping groove is tightly fitted to the outer wall of the drainage tube. The temperature detection element directly contacts the drainage tube through the inner wall of the clamping groove, indirectly collecting bile temperature data and transmitting it to the control module. This data, combined with the bile flow rate data detected by the ultrasonic transducers, enables dual monitoring of the risk of blockage and biliary inflammation.

[0021] Compared with the prior art, the beneficial effects of the present invention are:

[0022] 1. This invention achieves multi-directional fixation and protection of the drainage tube through a clamping and protection mechanism, solving the problem of poor protection effect of existing devices. At the same time, with the collaborative work of the complication monitoring component and control module, it realizes accurate real-time monitoring of patient body temperature, bile flow rate and bile temperature, effectively making up for the deficiency of insufficient complication risk monitoring capability of existing devices, and ultimately providing safer and more efficient auxiliary support for PTCD in clinical interventional treatment of tumors.

[0023] 2. This invention features an adjustable and adaptable restraint strap assembly. By utilizing the Velcro fasteners between the two ends of the fixing strap and the upper and lower connecting straps, the length of the restraint strap can be flexibly adjusted to fit patients with different waist sizes. At the same time, the breathable hole design of the adhesive tape ensures skin breathability, reduces the stuffiness and discomfort caused by long-term wear, and greatly improves the fit and comfort of postoperative wear for patients.

[0024] 3. This invention features a simple installation and adjustment system. The clamping frame assembly can be quickly fixed to the external support structure using a U-shaped frame and fastening bolts. The gooseneck tube assembly can be easily adjusted in height using a sleeve and adjusting bolts. The sensor and monitoring host are connected by a plug-in connection. Subsequent maintenance or adjustment does not require disassembling the entire device, which significantly reduces the operational difficulty for medical staff and improves the convenience of device installation and maintenance. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the overall structure of the invention from a front-end oblique tilting angle;

[0026] Figure 2 yes Figure 1 Enlarged view of region A in the middle;

[0027] Figure 3 This is a schematic diagram of the overall structure of the invention from a rear-end oblique top-down view;

[0028] Figure 4 yes Figure 3 Enlarged view of region B in the middle;

[0029] Figure 5 This is a three-dimensional structural schematic diagram of the restraint strap assembly of the present invention;

[0030] Figure 6 This is a three-dimensional structural diagram of the fixing strap of the present invention;

[0031] Figure 7 This is a three-dimensional structural diagram of the upper connecting strip of the present invention from a first perspective;

[0032] Figure 8 This is a three-dimensional structural diagram of the upper connecting strip of the present invention from a second perspective;

[0033] Figure 9 This is a three-dimensional structural diagram of the lower connecting strip of the present invention.

[0034] In the diagram: 1. Monitoring host; 2. Temperature sensor; 3. Ultrasonic flow sensor; 4. C-shaped frame; 5. Guide rod; 6. Fastening bolt; 7. Socket; 8. Gooseneck tube; 9. Adjusting bolt; 10. Mounting tube; 11. L-shaped connecting rod; 12. Connecting plate; 13. Hook; 14. Fixing strap; 141. First through hole; 142. Second through hole; 143. First Velcro; 144. Second Velcro; 145. Second vent group; 15. Upper connecting strap; 151. Third Velcro; 152. Fourth Velcro; 16. Lower connecting strap; 161. Fifth Velcro; 162. Sixth Velcro; 17. Release paper; 18. Display screen; 19. Alarm. Detailed Implementation

[0035] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0036] The following description, in conjunction with the accompanying drawings and specific embodiments, provides further details:

[0037] like Figures 1-4 and Figure 6 As shown, a percutaneous hepatic biliary drainage auxiliary device for interventional oncology includes three core components: a clamping and protection mechanism, a complication monitoring component, and a restraint strap component. These components work together to achieve drainage tube fixation, complication monitoring, and patient adaptation. The clamping and protection mechanism consists of a clamping frame component and a gooseneck tube component. The gooseneck tube component is mounted on the clamping frame component and can be adjusted vertically to accommodate patient positioning and drainage tube routing. The core of the complication monitoring component is the monitoring host 1, which is mounted on the clamping frame component and electrically connected to a temperature sensor 2 and an ultrasonic flow sensor 3. The temperature sensor 2 monitors the patient's body temperature in real time, detecting any abnormal temperatures caused by infection. The ultrasonic flow sensor 3 is connected to the drainage tube to monitor bile flow rate non-invasively, avoiding damage to the drainage tube's integrity. The restraint belt assembly can be wrapped around and fixed to the patient's waist and abdomen. It has a first through hole 141 and a second through hole 142. The first through hole 141 is for the drainage tube to pass through for limitation, and the second through hole 142 is for the temperature probe of the temperature sensor 2 to pass through, ensuring that the probe fits the patient's skin.

[0038] like Figure 2 and Figure 4As shown, the clamping frame assembly, serving as the support structure for the clamping and protection mechanism, consists of a U-shaped frame 4 and a guide rod 5. The guide rod 5 is vertically fixed to the U-shaped frame 4, and the gooseneck tube assembly is installed on the guide rod 5. To achieve the fixation of the clamping frame assembly to the external support structure (such as bed rails or bed edges), a first threaded through hole is provided on the bottom wall of the U-shaped frame 4. A fastening bolt 6 is installed in the threaded hole, and a clamping plate can be detachably installed at the top of the rod of the fastening bolt 6. For example, the two can be connected by screws. Note that a groove is provided on the upper surface of the clamping plate to accommodate the head of the screw, with the upper end of the screw head higher than the upper surface of the clamping plate. In use, the opening of the U-shaped frame 4 is clamped onto the external structure, and the fastening bolt 6 is rotated to move the clamping plate to fit against the support structure. The bolt and clamping plate cooperate to achieve a firm fixation. The detachable design of the clamping plate facilitates adaptation to support structures of different sizes.

[0039] like Figure 2 and Figure 4 As shown, the gooseneck tube assembly consists of a sleeve 7 and a gooseneck tube 8. The gooseneck tube 8 is connected to the sleeve 7, and the sleeve 7 is fitted onto the guide rod 5, allowing it to slide up and down along the guide rod 5 to adjust its height. The sleeve 7 has a second threaded through-hole leading into the tube, with an adjusting bolt 9 threaded into the hole. When the sleeve 7 slides to the target height, the adjusting bolt 9 is tightened so that its end abuts against the guide rod 5, fixing the position of the sleeve 7 through friction. The sleeve 7 also has an inclined installation tube 10 connected to its wall. The gooseneck tube 8 is installed in the installation tube 10, which has a fixing structure to securely fix the gooseneck tube 8 and prevent it from coming loose. For example, a threaded set screw is installed on the wall of the installation tube 10, or a rubber sleeve is installed on the inner wall of the installation tube 10, with the gooseneck tube 8 tightly fitted into the rubber sleeve. The gooseneck tube 8 can be bent and maintain its shape, allowing for further adjustment of its fixing position according to the drainage tube's direction.

[0040] like Figure 2 and Figure 4 As shown, the monitoring host 1 and the C-shaped frame 4 are connected by an L-shaped connecting rod 11. Each end of the L-shaped connecting rod 11 has a connecting plate 12, which is fixed to the bottom wall of the monitoring host 1 housing and the vertical wall of the C-shaped frame 4 respectively by bolts. Hooks 13 are installed on the wall of the monitoring host 1 housing for suspending the drainage bag, ensuring the drainage bag's height matches the drainage tube outlet and preventing bile reflux or excessive pulling of the drainage tube.

[0041] like Figure 5 As shown, the restraint strap assembly consists of a fixing strap 14, an upper connecting strap 15, and a lower connecting strap 16. The first through hole 141 and the second through hole 142 are both opened on the fixing strap 14. The two ends of the fixing strap 14 are detachably connected to the upper connecting strap 15 and the lower connecting strap 16, respectively. The ends of the upper connecting strap 15 and the lower connecting strap 16 away from the fixing strap 14 can also be detachably connected, which facilitates the wearing and removal of the device.

[0042] like Figures 5-9 As shown, the fixing strap 14 has a first hook and loop fastener 143 and a second hook and loop fastener 144 at both ends. The upper connecting strap 15 has a third hook and loop fastener 151 at one end connected to the fixing strap 14 and a fourth hook and loop fastener 152 at the other end. The lower connecting strap 16 has a fifth hook and loop fastener 161 at one end connected to the fixing strap 14 and a sixth hook and loop fastener 162 at the other end. When worn, the third hook and loop fastener 151 are fitted and fastened to the first hook and loop fastener 143, and the fifth hook and loop fastener 161 are fitted and fastened to the second hook and loop fastener 144. The connection length between the fixing strap 14 and the connecting strap can be adjusted. Then, the fourth hook and loop fastener 152 are fitted and fastened to the sixth hook and loop fastener 162 to fix the restraint strap assembly to the patient's waist and abdomen, adapting to patients with different waist sizes.

[0043] like Figure 5 and Figure 6 As shown, the fixing strap 14 has two adhesive patches spaced apart along its length, with release paper 17 covering the adhesive surface. A first through-hole 141 and a second through-hole 142 are located between the two adhesive patches. When in use, the release paper 17 is removed, and the adhesive patches can be adhered to the patient's abdominal skin, improving the stability of the fixing strap 14's fit to the skin. A first group of ventilation holes is provided on the adhesive patches, and a second group of ventilation holes 145 is provided on the fixing strap 14 at the corresponding positions of the adhesive patches. Each ventilation hole in the second group of ventilation holes 145 is aligned with each ventilation hole in the first group of ventilation holes, ensuring skin breathability and reducing stuffiness and discomfort caused by prolonged wear.

[0044] like Figures 1-3 As shown, the monitoring host 1 has a control module inside, which includes a circuit board and an MCU chip mounted on the circuit board. The front wall of the monitoring host 1 housing has a display screen 18 and two sensor connection ports, and the top of the monitoring host 1 has an alarm 19. Temperature sensor 2 and ultrasonic flow sensor 3 are connected to their respective sensor connection ports. The display screen 18, alarm 19, and all sensor connection ports are electrically connected to the control module. The ultrasonic flow sensor 3 has a clamp-type sensor probe, which integrates two symmetrically arranged ultrasonic transducers and a temperature detection element, and has a clamping groove adapted to the drainage tube. When the probe clamps the drainage tube, the inner wall of the clamping groove is tightly fitted to the outer wall of the drainage tube. The temperature detection element contacts the drainage tube through the inner wall of the clamping groove, indirectly collecting bile temperature data and transmitting it to the control module. This data, combined with the bile flow rate data detected by the ultrasonic transducers, enables dual monitoring of the risk of blockage and biliary inflammation. When the data exceeds a preset threshold, the control module controls the alarm 19 to sound an alarm, and the display screen 18 displays the monitoring data in real time.

[0045] The working principle of this invention includes four parts: installation and fixing, function debugging, real-time monitoring, and dynamic adaptation, as detailed below:

[0046] 1. Install and secure the entire device: Secure the open end of the U-shaped frame 4 of the clamping frame assembly to the external support structure such as the bed rail or bedside table. Rotate the fastening bolts 6 on the bottom wall of the U-shaped frame 4 to move the clamping plate towards the support structure until the clamping plate is tightly fitted to the support structure, thus completing the secure fixation of the clamping frame assembly. Then, wrap the restraint strap assembly around the patient's waist and abdomen, aligning the first through hole 141 with the puncture site. Remove the release paper 17 from the adhesive on the fixing strap 14, allowing the adhesive to adhere to the patient's skin. Adjust the connection length between the fixing strap 14 and the upper connecting strap 15 and the lower connecting strap 16 by matching and pasting the first hook and loop fastener 143 with the third hook and loop fastener 151, and the second hook and loop fastener 144 with the fifth hook and loop fastener 161. Finally, attach and secure the fourth hook and loop fastener 152 with the sixth hook and loop fastener 162, ensuring that the restraint strap assembly fits tightly to the patient's body without causing significant pressure.

[0047] II. Debugging and Connecting Functional Components: After puncture, the drainage tube passes through the first through hole 141 on the fixing band 14 of the restraint assembly. The drainage tube is then passed through the gooseneck tube 8 of the gooseneck tube assembly and connected to the drainage bag hanging on the hook 13. Most of the drainage tube passes through the gooseneck tube 8 and is protected within it. The sliding sleeve 7 is adjusted in height along the guide rod 5 to position the drainage tube at a reasonable drainage angle (usually 15°-30° to the horizontal). Then, the adjusting bolt 9 on the sleeve 7 wall is tightened to fix the position of the sleeve 7. If fine-tuning of the drainage tube's direction is required, the gooseneck tube 8 can be bent to the target shape, utilizing its shape retention characteristic to fix the drainage tube's position. Simultaneously, the probe of the temperature sensor 2 is passed through the second through hole 142 on the fixing band 14, ensuring it fits against the skin around the patient's puncture point. The plugs of the temperature sensor 2 and the ultrasonic flow sensor 3 are inserted into the corresponding sensor connection ports on the monitoring host 1 to complete the electrical connection.

[0048] III. Postoperative Real-Time Monitoring Phase: After the control module within the monitoring host 1 is activated, the temperature sensor 2 continuously collects the patient's body temperature data. Once the clamp-type probe of the ultrasonic flow sensor 3 clamps the drainage tube, its two symmetrically arranged ultrasonic transducers (transmitter and receiver, respectively) will activate under the command of the control module. The control module outputs a trigger signal to the ultrasonic flow sensor 3 through the sensor connection port, causing the transducer (transmitter) located upstream of the bile flow to emit an ultrasonic signal. This signal passes through the drainage tube wall and the bile within the tube and is received by the transducer (receiver) located downstream. Simultaneously, the control module records the downstream propagation time T1 of the ultrasonic wave from the transmitter to the receiver. Subsequently, under the control of the control module, the roles of the two transducers are reversed: the downstream transducer becomes the transmitter, and the upstream transducer becomes the receiver, emitting and receiving ultrasonic signals again, and recording the upstream propagation time T2.

[0049] Because bile flow can either "boost" or "hinder" the propagation of ultrasound waves—when flowing downstream, the bile flow direction is the same as the ultrasound propagation direction, shortening the propagation time T1; when flowing upstream, the direction is opposite, lengthening the propagation time T2, and the faster the bile flow rate, the greater the difference between T1 and T2 (ΔT=T2-T1). Therefore, the control module uses a preset algorithm (specifically v=K×ΔT, where K is a calibration coefficient determined by parameters such as the inner diameter of the drainage tube, the ultrasound propagation speed, and the probe installation angle, which has been experimentally calibrated and stored in the control module before leaving the factory) to calculate the real-time bile flow rate v by substituting the collected T1 and T2 data.

[0050] Simultaneously, the temperature sensing element inside the clamp-on probe of the ultrasonic flow sensor synchronously collects the temperature of the outer wall of the drainage tube (indirectly reflecting the bile temperature) and transmits the temperature data to the control module. The control module then performs temperature compensation correction on the calculated flow velocity v based on the effect of temperature on the propagation speed of ultrasound in bile. Because the propagation speed of ultrasound in liquids increases with increasing temperature, without compensation, temperature changes will lead to errors in flow velocity calculation. Compensation can improve the accuracy of flow velocity monitoring to within ±2%.

[0051] Finally, the control module integrates the corrected real-time bile flow rate data with the patient's body temperature data transmitted by temperature sensor 2 and the bile temperature data transmitted by temperature detection element. This data is then displayed in real-time on the display screen 18 for medical staff to view intuitively. When the control module detects that the body temperature exceeds the first temperature setting threshold (e.g., 37.5℃), the bile flow rate is lower than the set flow rate threshold (e.g., 0.3ml / min), or the bile temperature is higher than the second temperature setting threshold (e.g., 38℃), it immediately triggers the alarm 19 on the monitoring host 1 to issue an audible and visual alarm signal, reminding medical staff to promptly check for biliary inflammation or drainage tube blockage.

[0052] IV. Finally, dynamic adaptation and maintenance of the device: If the patient needs to turn over or adjust their position, the gooseneck tube 8 can be slightly pulled to adjust the position of the drainage tube using its bendable characteristics, avoiding traction on the drainage tube due to changes in body position. If the drainage angle needs to be adjusted, simply loosen the adjusting bolt 9 of the sleeve tube 7, slide the sleeve tube 7 along the guide rod 5 to change its height, and then retighten the bolt to achieve dynamic adjustment of the drainage tube height. The entire process does not require disassembling the entire device, ensuring continuous monitoring while improving the convenience and safety for patients.

[0053] In summary, this invention achieves multi-directional fixation and protection of the drainage tube through a clamping and protection mechanism, solving the problem of poor protection effect of existing devices. At the same time, with the collaborative work of the complication monitoring component and control module, it realizes accurate real-time monitoring of patient body temperature, bile flow rate and bile temperature, effectively making up for the deficiency of existing devices in complication risk monitoring capabilities, and ultimately providing safer and more efficient auxiliary support for PTCD in clinical interventional treatment of tumors.

[0054] The above are merely preferred embodiments of the present invention and are not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A percutaneous hepatic biliary drainage auxiliary device for clinical interventional tumor treatment, characterized in that, include: The clamping protection mechanism includes a clamping frame assembly and a gooseneck tube assembly disposed on the clamping frame assembly and adjustable in position along the vertical direction; Complication monitoring component includes a monitoring host (1) mounted on a clamping frame assembly, a temperature sensor (2) electrically connected to the monitoring host (1), and an ultrasonic flow sensor (3); the temperature sensor (2) is used to monitor the patient's body temperature in real time, and the ultrasonic flow sensor (3) is connected to a drainage tube to achieve non-invasive monitoring of bile flow rate; A restraint assembly for wrapping and fixing around the patient’s waist and abdomen, the restraint assembly having a first through hole (141) for the passage of a drainage tube and a second through hole (142) for the passage of a temperature probe of a temperature sensor (2).

2. The percutaneous hepatic biliary drainage auxiliary device for clinical interventional tumor treatment according to claim 1, characterized in that, The clamping frame assembly includes an inverted bracket (4) and a guide rod (5) vertically arranged on the inverted bracket (4). The gooseneck tube assembly is arranged on the guide rod (5). A first threaded through hole is provided on the bottom wall of the inverted bracket (4), and a fastening bolt (6) is threadedly installed in the first threaded through hole. A clamping plate is detachably installed on the top of the rod of the fastening bolt (6).

3. The percutaneous hepatic biliary drainage auxiliary device for interventional tumor treatment according to claim 2, characterized in that, The gooseneck tube assembly includes a sleeve tube (7) and a gooseneck tube (8), the gooseneck tube (8) being connected to the sleeve tube (7); the sleeve tube (7) is sleeved on the guide rod (5) and can slide up and down along the guide rod (5); the sleeve tube (7) has a second threaded through hole leading to the inside of the tube, and an adjusting bolt (9) is threaded in the second threaded through hole.

4. The percutaneous hepatic biliary drainage auxiliary device for clinical interventional tumor treatment according to claim 3, characterized in that, The sleeve (7) is connected to an inclined installation pipe (10), the gooseneck pipe (8) is installed in the installation pipe (10), and the installation pipe (10) is provided with a fixing structure for fixing the gooseneck pipe (8).

5. The percutaneous hepatic biliary drainage auxiliary device for clinical interventional tumor treatment according to claim 2, characterized in that, The monitoring host (1) and the slanted frame (4) are connected by a connecting L-shaped connecting rod (11); each end of the L-shaped connecting rod (11) is provided with a connecting plate (12), and the two connecting plates (12) are respectively connected to the shell wall of the monitoring host (1) and the vertical wall of the slanted frame (4) by bolts, and a hook (13) is installed on the shell wall of the monitoring host (1).

6. The percutaneous hepatic biliary drainage auxiliary device for clinical interventional tumor treatment according to claim 1, characterized in that, The restraint strap assembly includes a fixing strap (14), an upper connecting strap (15), and a lower connecting strap (16). The first through hole (141) and the second through hole (142) are disposed on the fixing strap (14). The two ends of the fixing strap (14) are detachably connected to the upper connecting strap (15) and the lower connecting strap (16), respectively. The ends of the upper connecting strap (15) and the lower connecting strap (16) away from the fixing strap (14) are detachably connected.

7. The percutaneous hepatic biliary drainage auxiliary device for clinical interventional tumor treatment according to claim 6, characterized in that, The fixing strap (14) is provided with a first hook and loop fastener (143) and a second hook and loop fastener (144) at both ends respectively. The upper connecting strap (15) is provided with a third hook and loop fastener (151) at one end connected to the fixing strap (14) and a fourth hook and loop fastener (152) at the other end. The lower connecting strap (16) is provided with a fifth hook and loop fastener (161) at one end connected to the fixing strap (14) and a sixth hook and loop fastener (162) at the other end. The third hook and loop fastener (151) and the fifth hook and loop fastener (161) are adapted and connected to the first hook and loop fastener (143) and the second hook and loop fastener (144) respectively. The fourth hook and loop fastener (152) and the sixth hook and loop fastener (162) are adapted and connected.

8. The percutaneous hepatic biliary drainage auxiliary device for clinical interventional tumor treatment according to claim 6, characterized in that, Two adhesive strips are provided on the fixing strip (14) at a distance along its length direction. Release paper (17) is provided on the bonding surface of the adhesive strips. The first through hole (141) and the second through hole (142) are located between the two adhesive strips.

9. The percutaneous hepatic biliary drainage auxiliary device for interventional tumor treatment according to claim 8, characterized in that, The adhesive is provided with a first group of vent holes, and the fixing band (14) is provided with a second group of vent holes (145) corresponding to the positions of the two adhesives. Each vent hole of the second group of vent holes (145) is aligned with each vent hole of the first group of vent holes.

10. A percutaneous hepatic biliary drainage auxiliary device for interventional tumor treatment according to any one of claims 1-9, characterized in that, The monitoring host (1) is equipped with a control module. The front wall of the monitoring host (1) is equipped with a display screen (18). The upper end of the monitoring host (1) is equipped with an alarm (19). The monitoring host (1) is also equipped with a sensor connection port. The temperature sensor (2) and the ultrasonic flow sensor (3) are respectively connected to the corresponding sensor connection port. The display screen (18), the alarm (19) and each sensor connection port are electrically connected to the control module. The ultrasonic flow sensor (3) has a clamp-type sensor probe. The clamp-type sensor probe integrates two symmetrically arranged ultrasonic transducers and a temperature detection element. The clamp-type sensor probe has a clamping groove adapted to the drainage tube. When the clamp-type sensor probe clamps the drainage tube, the inner wall of the clamping groove is tightly attached to the outer wall of the drainage tube. The temperature detection element directly contacts the drainage tube through the inner wall of the clamping groove, indirectly collects bile temperature data and transmits it to the control module. It works in conjunction with the bile flow rate data detected by the ultrasonic transducer to achieve dual monitoring of the risk of blockage and biliary inflammation.