A self-adapting fixing and closed irrigation device for post-cardiovascular surgery catheter

Abstract

This invention relates to a post-operative adaptive fixation and closed-loop flushing device for cardiovascular catheters, belonging to the field of medical device technology. It includes an external control unit, an integrated dual-channel drainage catheter, a buffer fixation base with integrated mechanical monitoring, and a multi-functional switching valve. The integrated dual-channel drainage catheter forms independent flushing microchannels within its wall through a unique co-extrusion molding process. The buffer fixation base continuously monitors and buffers abnormal mechanical tension on the catheter through built-in sensing elements and damping structures. The external control unit, combined with the intelligent switching valve, automatically analyzes the working status of the drainage system based on real-time mechanical signals and fluid pressure changes. This device enables intelligent identification of the post-operative pocket drainage status, safe flushing under completely closed conditions, and dynamic adaptive fixation of the catheter, thereby effectively improving nursing safety, reducing patient discomfort, and lowering the risk of complications.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a cardiovascular postoperative catheter adaptive fixation and closed flushing device. Background Technology

[0002] Following surgery for cardiovascular electronic implantable devices such as pacemakers and implantable cardioverter defibrillators, the placement of a catheter in a subcutaneous pocket is crucial for managing postoperative exudate and preventing hematoma and infection. The secure fixation and patency of the catheter directly impact the success of the surgery and the quality of patient recovery, making it one of the most fundamental and important tasks in postoperative care.

[0003] Currently, the standard clinical practice is to simply and rigidly fix the catheter to the patient's skin surface using sutures or medical tape. This method ignores the fact that the human body is a dynamic living organism. Post-operatively, patients inevitably breathe, cough, and adjust their position, resulting in slight relative displacement between the skin and subcutaneous tissue. A rigidly fixed catheter cannot adapt to this displacement, and its tip will experience continuous shearing and friction with the fragile healing pouch tissue. This not only causes significant pain and discomfort for the patient but may also irritate local tissues, exacerbate the inflammatory response, delay the healing process, and even become a mechanical cause of complications. Regarding catheter function maintenance, the biggest challenge currently faced is the emergency handling of catheter blockage. When drainage stops, medical staff find it difficult to immediately determine whether the cause is successful drainage of fluid or blood clots blocking the lumen. Once a blockage is confirmed or highly suspected, the existing technical solution is to flush the tube by connecting a syringe to a three-way valve. This operation requires interrupting the negative pressure and disconnecting the tubing. In a busy clinical environment, this procedure is cumbersome. More importantly, it completely destroys the airtight barrier of the drainage system, allowing potential pathogens from the air and environment to enter the patient's body retrogradely, bringing a significant risk of nosocomial infection.

[0004] Therefore, existing technologies effectively separate the closely related nursing goals of "catheter fixation" and "patency maintenance," creating a dilemma: either sacrificing patient dynamic comfort and tissue compatibility for secure fixation, or sacrificing the overall system's ease of operation and infection control safety for managing blockages. Clinically, there is an urgent need for an innovative device that can comprehensively address this dilemma. This device should both adaptively fix the catheter like a "smart joint," buffering stress from daily activities, and provide rapid and convenient emergency flushing capabilities like a "built-in fire escape," while maintaining a completely sealed system. This would thereby improve the safety, effectiveness, and humanization of postoperative management at the system level. Summary of the Invention

[0005] In view of this, the purpose of this invention is to propose an adaptive fixation and closed-loop flushing device for cardiovascular postoperative catheters. By setting up a collaborative system consisting of an integrated dual-channel catheter with co-extruded microtubes on the sidewalls, a buffer fixation base integrating a flexible pressure-sensing film and viscoelastic damping material, a valve body with multi-channel switching function, and a main controller that executes intelligent diagnostic programs, this invention solves the problems in the prior art where the postoperative pocket drainage status cannot be objectively judged, rigid fixation leads to harmful shearing of the tissue interface, and safe closed-loop flushing operations are complex and pose a risk of contamination.

[0006] This invention is achieved through the following technical solution:

[0007] A cardiovascular postoperative catheter adaptive fixation and closed flushing device includes an external control unit, an integrated dual-channel drainage catheter, an integrated mechanical monitoring buffer fixation base, and a multi-functional switching valve.

[0008] The main controller, micro negative pressure pump and micro flushing pump are fixedly installed inside the housing of the external control host, and the surface of the housing of the external control host is provided with a display interface.

[0009] The integrated dual-channel flow guide includes a main body and sidewall microtubes. The main body has a main flow cavity inside, and the distal sidewall of the main body has a porous flow guide section that communicates with the main flow cavity. The sidewall microtubes are co-extruded and completely embedded in the tube wall of the main body during the manufacturing process, and the sidewall microtubes have independent lateral outflow holes at the distal end of the main body.

[0010] The integrated mechanical monitoring buffer fixation base includes an adhesive base plate, a catheter locking component, and a universal damping joint. The lower surface of the adhesive base plate is covered with a medical adhesive layer. The lower end of the universal damping joint is fixedly connected to the adhesive base plate, and the upper end of the universal damping joint is fixedly connected to the catheter locking component. The interior of the universal damping joint is filled with a viscoelastic damping material, and a flexible pressure sensing film is integrated into the viscoelastic damping material.

[0011] The multi-functional switching valve is provided with a first pipeline interface, a second pipeline interface and a third pipeline interface on its valve body, and a valve core drive module is movably arranged inside the valve body.

[0012] The proximal end of the integrated dual-channel flow guide tube is connected to the first pipeline interface of the multi-functional switching valve through the main pipeline, and the proximal end of the sidewall microtube is directly connected to the outlet of the micro flushing pump through the micro pipeline.

[0013] The inlet of the miniature negative pressure pump is connected to the second pipeline interface of the multi-functional switching valve via a negative pressure pipeline;

[0014] The inlet of the miniature flushing pump is connected to a flushing fluid source;

[0015] The main controller is electrically connected to the flexible pressure sensing membrane, the valve core drive module, the micro negative pressure pump, the micro flushing pump, and the display interface via control circuits.

[0016] Furthermore, the universal damping joint allows the conduit locking member to make small, damped deflections in multiple directions relative to the adhesive base plate.

[0017] Furthermore, the valve core drive module of the multi-functional switching valve can move within the valve body to switch between different fluid passage states; the different fluid passage states include at least a first state in which the first pipeline interface is connected to the second pipeline interface, and a second state in which the first pipeline interface is connected to a pressure monitoring chamber and the third pipeline interface is connected to the micro flushing pump.

[0018] Furthermore, the device also includes a pressure sensor, the detection end of which is connected to the pressure monitoring chamber, and the signal output end of which is connected to the main controller.

[0019] Furthermore, the main controller is configured to execute a status diagnostic program; the status diagnostic program includes: controlling the valve core drive module to switch to the second state, and controlling the micro flushing pump to inject a quantitative amount of liquid into the target area through the micro-tube and the sidewall micro-tube, while acquiring pressure change data of the proximal end of the main flow chamber through the pressure sensor.

[0020] Furthermore, during the execution of the state diagnostic procedure, the main controller synchronously acquires the mechanical baseline data monitored by the flexible pressure sensing film.

[0021] Furthermore, the sidewall microtube has a bypass pressure relief structure on the section near its proximal end, which is separated from the main flow cavity by a selected permeable material.

[0022] Furthermore, the device also includes a wireless communication module, which is connected to the main controller and is used to transmit system operating status, alarm information, or operation logs to an external terminal.

[0023] The beneficial effects of this invention are as follows:

[0024] This invention presents a postoperative pouch management device that integrates a basic drainage and closed-loop flushing structure, a mechanical sensing and dynamic buffering fixation structure, and an intelligent status diagnosis structure. Through an integrated co-extruded dual-channel catheter, the flushing fluid is injected via independent microchannels, achieving safe flushing without compromising the system's airtightness and significantly reducing the risk of retrograde infection due to interventional procedures. The integrated, sensor-equipped buffering fixation base continuously monitors the catheter's stress state and provides flexible cushioning, effectively mitigating tissue interface shear forces caused by patient movement and reducing patient pain and local tissue damage. The intelligent switching valve, in synergy with the main controller, automatically performs drainage status analysis based on mechanical signals and fluid pressure changes, clearly distinguishing different reasons for drainage cessation and providing objective and accurate decision support for medical staff, avoiding blind intervention based on experience. Overall, this device improves the safety, comfort, and intelligence of postoperative pouch care, significantly reducing the probability of related complications and the workload of nursing staff. Attached Figure Description

[0025] Figure 1 For the overall assembly structure drawing;

[0026] Figure 2 Front view of the overall assembly structure;

[0027] Figure 3 Side view of the overall assembly structure;

[0028] Figure 4 Top view of the overall assembly structure;

[0029] Figure 5 This is a diagram of the internal structure of the external control unit;

[0030] Figure 6 This is a structural diagram of a buffer fixed base for integrated mechanical monitoring.

[0031] Explanation of reference numerals in the attached figures:

[0032] 1. External control unit; 2. Main controller; 3. Miniature negative pressure pump; 4. Miniature flushing pump; 6. Integrated dual-channel guide tube; 7. Main tube body; 8. Side wall microtubes; 9. Main flow chamber; 10. Porous guide section; 11. Lateral outflow hole; 12. Integrated mechanical monitoring buffer fixing base; 13. Adhesive base plate; 14. Catheter locking component; 15. Universal damping joint; 16. Medical adhesive layer; 17. Viscoelastic damping material; 18. Flexible pressure sensing membrane; 19. Multifunctional switching valve; 20. First pipeline interface; 21. Second pipeline interface; 22. Third pipeline interface; 23. Valve core drive module; 24. Main pipeline; 25. Microtubes; 26. Negative pressure pipeline; 27. Fluid source; 29. ​​Pressure monitoring chamber; 30. Pressure sensor. Detailed Implementation

[0033] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0034] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0035] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0036] In the above description of the present invention, it should be noted that the terms "one side," "the other side," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the invention is conventionally placed during use. These terms are used only for the convenience of describing the present invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0037] Furthermore, terms such as "identical" do not imply that components must be absolutely identical; minor differences are permissible. The term "perpendicular" simply means that the positional relationship between components is more perpendicular than "parallel," not that the structure must be perfectly perpendicular; a slight tilt is acceptable.

[0038] like Figure 1-6 As shown, one embodiment of the present invention provides a cardiovascular postoperative catheter adaptive fixation and closed-loop flushing device, comprising an external control unit 1 serving as the system control and power unit, a disposable integrated dual-channel drainage catheter 6, a buffer fixation base 12 with integrated mechanical monitoring and sensing functions, and a multi-functional switching valve 19 for precisely switching the system's working flow path. These components are organically integrated through precise mechanical interfaces, fluid lines, and electrical circuits to form a collaborative intelligent system.

[0039] The external control unit 1 is the brain and power source of the entire device. Its outer shell is made of medical-grade engineering plastic, and internally, the main controller 2, miniature negative pressure pump 3, and miniature flushing pump 4 are fixed in place with screws. The main controller 2 is a circuit board integrating a microprocessor, storage unit, and input / output interfaces, responsible for processing all sensor signals, executing control algorithms, and driving various actuators. The miniature negative pressure pump 3 is a diaphragm vacuum pump; its inlet is threaded to a section of negative pressure tubing 26, used to generate and maintain the negative pressure required by the system. The miniature flushing pump 4 is a high-precision peristaltic pump; its pump head is fixed with clips, and its pump tubing is connected to the outlet tubing of the flushing fluid source 27 and subsequent micro-tubing 25 for precise delivery of the flushing fluid. An LCD touchscreen is embedded in the front panel of the external control unit 1 as a display interface, which is connected to the main controller 2 via a ribbon cable for parameter setting, status display, and command input. Multiple electrical sockets and quick-connect fittings are located on the side of the unit for connecting external components.

[0040] The integrated dual-channel drainage catheter 6 is manufactured from highly biocompatible medical-grade silicone rubber through a one-time co-extrusion molding process. The main body of the catheter is the main tube 7, which contains a circular main flow cavity 9. At the distal end of the main tube 7 (i.e., the end inserted into the human pouch), its sidewall is precision-machined with a dense, porous flow-guiding section 10 using laser technology. These micropores are all connected to the main flow cavity 9 to expand the flow-guiding area and prevent blockage caused by tissue adhesion. Inside the wall of the main tube 7, an independent sidewall microtube 8 is simultaneously embedded during the co-extrusion molding process. The sidewall microtube 8 is completely embedded within the wall material of the main tube 7, and its outer wall smoothly transitions with the outer wall of the main tube, forming a whole. This creates an independent fluid channel with almost no increase in the overall outer diameter and rigidity of the catheter. At the distal end of the main body 7, near the tip but in front of the porous guide section 10, a sidewall microtube 8 forms a lateral outflow hole 11 through a finer laser-drilled micro-hole. This hole communicates only with the sidewall microtube 8 and is physically completely isolated from the main flow cavity 9. The proximal ends (external ends) of both the main body 7 and the sidewall microtube 8 have reinforced Luer connectors for reliable connection.

[0041] The integrated mechanical monitoring buffer fixation base 12 is responsible for stably fixing the catheter to the patient's body surface and monitoring the mechanical state of the catheter in real time. Its base is a circular adhesive base plate 13, the lower surface of which is covered with a pressure-sensitive medical adhesive layer 16, and the outside is covered with release paper. Upon use, the release paper is removed for secure adhesion to the skin. Above the center of the adhesive base plate 13, the lower shell of the universal damping joint 15 is ultrasonically welded. The universal damping joint 15 is filled with a viscoelastic damping material 17, similar to high-damping silicone, which absorbs energy and provides gentle resistance. Above the universal damping joint 15, a catheter locking element 14 is threadedly connected. The catheter locking element 14 has a slot with a locking knob for clamping the main body 7 of the integrated dual-channel catheter 6. Crucially, a flexible pressure-sensing membrane 18 is pre-embedded and encapsulated inside the viscoelastic damping material 17. The lead wire of this flexible pressure-sensing film 18 extends from the side waterproof interface of the universal damping joint 15, forming a small cable with a connector. When the catheter is subjected to lateral tensile or torsional forces, the force is transmitted to the universal damping joint 15 through the catheter locking member 14, causing the viscoelastic damping material 17 to deform, thereby changing the pressure distribution on the internal flexible pressure-sensing film 18. This change is converted into an electrical signal output. Therefore, the buffer fixing base 12 simultaneously achieves two major functions: "dynamic buffering" and "mechanical sensing": the universal damping joint 15 allows the catheter to adaptively deflect within a small range, buffering the relative displacement between tissue and skin; the flexible pressure-sensing film 18 quantifies the stress state of the catheter in real time.

[0042] The multi-functional switching valve 19 is a modular fluid control component. Its valve body is made of medical-grade plastic and has three standard Luer lock interfaces machined on it: a first pipeline interface 20, a second pipeline interface 21, and a third pipeline interface 22. The valve body internally has precision-machined flow channels and a cylindrical valve cavity. The valve core drive module 23 includes a miniature stepper motor and a piston-type slider driven by the motor via a screw, both fixed to the valve body by a bracket. The piston-type slider is equipped with a sealing ring and can move linearly within the valve cavity. The main controller 2 precisely controls the rotation of the stepper motor, driving the slider to stop at three preset positions, thereby changing the connection relationship between the three interfaces. Furthermore, inside the valve body, a small pressure monitoring chamber 29 is branched off from the flow channel connected to the first pipeline interface 20. A high-precision pressure sensor 30 is installed in the pressure monitoring chamber 29 to monitor the pressure in that channel.

[0043] The above modules are connected and combined into a whole system in the following way:

[0044] The Luer connector at the proximal end of the main body 7 of the integrated dual-channel flow guide duct 6 is connected to the first pipeline interface 20 of the multi-functional switching valve 19 via a flexible main pipeline 24 in a threaded locking manner.

[0045] The special micro-connector at the proximal end of the microtube 8 on the side wall of the integrated dual-channel flow guide duct 6 is connected to the pump tube outlet end of the micro flushing pump 4 through a thinner micro-tube 25.

[0046] The air inlet of the miniature negative pressure pump 3 is connected to the second pipeline interface 21 of the multi-functional switching valve 19 through the negative pressure pipeline 26.

[0047] A soft bag containing sterile saline solution serves as the flushing fluid source 27, with its outlet line connected to the inlet of the miniature flushing pump 4.

[0048] The connectors leading out from the flexible pressure sensing film 18 of the buffer fixing base 12 are inserted into the corresponding sensor sockets of the external control host 1.

[0049] The wires of the valve core drive module 23 (stepper motor) of the multi-functional switching valve 19 and the wires of the pressure sensor 30 are respectively connected to the control port of the external control host 1.

[0050] At this point, all electrical connections are routed to the main controller 2 via control lines, and all fluid pathways are connected via pipes and valves.

[0051] The specific steps for using this device in clinical practice are as follows:

[0052] Step 1: Postoperative catheter placement and system connection.

[0053] Before suturing the subcutaneous pocket during pacemaker or defibrillator implantation surgery, open the sterile packaging of the integrated dual-channel drainage catheter 6. Insert the porous drainage section 10 and distal portion of the catheter into the pocket cavity, ensuring the lateral outflow port 11 is also located within the pocket. Leave an appropriate length of the catheter's percutaneous exit segment. Remove the release paper from the adhesive base plate 13 of the cushioning fixation base 12 and firmly attach it to clean, dry skin next to the puncture site, ensuring easy visibility and avoiding bony prominences. Open the catheter locking mechanism 14, insert the main tube body 7 of the catheter into its slot, and then tighten the locking mechanism to secure the catheter. This fixation is not absolutely rigid, as the upper universal damping joint 15 allows for slight movement. Next, connect the tubing: Connect both ends of the main tubing 24 to the catheter main body 7 connector and the first tubing interface 20 of the multi-function switching valve 19, respectively; connect both ends of the micro-tubing 25 to the catheter sidewall micro-tubing 8 connector and the outlet of the micro-flushing pump 4, respectively; connect both ends of the negative pressure tubing 26 to the inlet of the micro-negative pressure pump 3 and the second tubing interface 21 of the multi-function switching valve 19, respectively. Finally, connect the sensor cable of the buffer fixing base 12 and the control cable of the multi-function switching valve 19 to the external control host 1. Suspend the flushing fluid source 27 (e.g., a 500ml saline bag) next to the host and connect its tubing to the inlet of the micro-flushing pump 4. After verifying that all connections are correct, prepare to start the system.

[0054] Step 2: System initialization and routine negative pressure diversion.

[0055] Medical staff click to power on the interactive display interface, and the system performs a self-test. After the self-test passes, the main controller 2 issues a command to drive the valve core drive module 23 to switch the multi-functional switching valve 19 to the first working state (i.e., the diversion position). In this state, the slider moves to connect the first pipeline interface 20 with the second pipeline interface 21, while blocking the third pipeline interface 22. Subsequently, the main controller 2 starts the miniature negative pressure pump 3, and the target negative pressure value (e.g., -10 to -20 kPa) can be set through the interface. At this time, a complete negative pressure diversion path is established: under the action of negative pressure, the fluid in the bag enters the main flow chamber 9 through the porous diversion section 10 of the catheter, flows through the main pipeline 24, the multi-functional switching valve 19 (from the first pipeline interface 20 to the second pipeline interface 21), and the negative pressure pipeline 26, and is finally collected in the diversion bag connected to the exhaust port of the miniature negative pressure pump 3. During this normal diversion stage, the buffer fixing base 12 continues to work. The flexible pressure sensing membrane 18 transmits the monitored real-time mechanical signal (typically a small-amplitude fluctuating voltage signal related to baseline tension) to the main controller 2 via control circuitry. The main controller 2 samples and filters these signals, calculating the real-time tension baseline value Fbaseline and the dynamic fluctuation range. The interactive display graphically shows the drainage status, real-time negative pressure value, and catheter force status indicator. If the flexible pressure sensing membrane 18 detects a force continuously exceeding the safety threshold Fthresholdhigh, or if the force signal suddenly disappears (below the threshold Fthresholdlow), the main controller 2 immediately triggers an audible and visual alarm, indicating "abnormal catheter traction" or "catheter possible dislodgement," requiring immediate examination by medical personnel.

[0056] Step 3: Intelligent flow diversion status diagnosis.

[0057] When the drainage fluid stops flowing (which can be determined by a drip rate sensor or observed manually) and this continues for a period of time (e.g., 30 minutes), the system can automatically prompt or medical staff can manually activate the "intelligent diagnosis" mode. This is a key aspect of the device's innovative functionality.

[0058] First, the main controller 2 controls the valve core drive module 23 to switch the multi-function switching valve 19 to the second working state (i.e., the diagnostic / flushing station). In this state, the slider moves to connect the first pipeline interface 20 to the pressure monitoring chamber 29 (while simultaneously cutting off the passage to the second pipeline interface 21), and connects the third pipeline interface 22 to the outlet passage of the micro flushing pump 4. At this time, the end of the main flow chamber 9 is temporarily connected to the atmospheric pressure environment through the pressure monitoring chamber 29, in preparation for subsequent pressure testing.

[0059] Next, the diagnostic algorithm is initiated. The main controller 2 first records and analyzes the current mechanical signal from the flexible pressure sensing membrane 18, calculating a steady-state tension reference value Fcurrent. Then, it controls the micro-flushing pump 4 to precisely inject a small amount of test fluid (e.g., 0.5 ml of sterile saline) into the sac at an extremely low, constant flow rate (e.g., 1 ml / min) through the microtubes 25 and sidewall microtubes 8. At the same time as the injection, the pressure sensor 30 begins sampling at a high frequency (e.g., 100 Hz), recording the pressure change at the first tubing interface 20, resulting in a pressure-time curve P(t).

[0060] The key signal processing and state determination algorithms are as follows:

[0061] The main controller 2 extracts features from the pressure curve P(t). Let the injection start time be t0, the injection end time be t1, and the analysis time window be [t0, t0+Δt] (e.g., Δt=30 seconds).

[0062] The extracted feature parameters include:

[0063] Maximum pressure Pmax: The maximum pressure reached within the time window.

[0064] Pressure rise slope Kup: The average slope from the start of a significant pressure rise to the point where the pressure reaches Pmax, Kup=(Pmax-P0) / (tpeak-tstart), where P0 is the initial pressure, tpeak is the time to reach Pmax, and tstart is the time when the pressure begins to rise.

[0065] Pressure plateau characteristics: Observe whether the pressure remains at a relatively stable value Pplateau after t1, and for how long.

[0066] Characteristics of pressure drop: Observe whether there is a phase of rapid pressure drop and the rate of drop.

[0067] Meanwhile, the system continuously monitors the mechanical signal F(t). For a normal, well-positioned catheter, F(t) should fluctuate within a small range, and Fcurrent should not differ significantly from the previously established Fbaseline.

[0068] State determination is a logical decision based on the fusion of multi-source signals:

[0069] Situation A: The judgment is that "the fluid in the sac has been basically emptied or significantly reduced".

[0070] Signal performance: The mechanical signal F(t) is stable and normal (|Fcurrent-Fbaseline|<ΔFnormal). The pressure curve shows that after injection begins, the pressure P(t) rises gradually to a moderate value Pmax (e.g., 5-12 kPa), and after injection stops, the pressure remains at a stable plateau Pplateau without significant decrease. This is because the small amount of injected liquid enters a basically empty, limited-volume bladder space and cannot immediately flow out through the orifice, thus the pressure is established and maintained.

[0071] Algorithm logic: IF(Fstatus==NORMAL)AND(Pmax is in the medium range)AND(there is a clear pressure plateau)THEN state = "high probability of fluid drainage".

[0072] System output: The interactive interface displays: "The drainage may have stopped due to a decrease in fluid accumulation. It is recommended to reduce the negative pressure to intermittent suction mode or prepare for extubation based on clinical assessment."

[0073] Case B: The diagnosis is "blood clots or fibrin blocking the catheter".

[0074] Signal performance: The mechanical signal F(t) is stable and normal. The pressure curve shows that after injection begins, the pressure P(t) rises rapidly, quickly reaching a high Pmax value (>15 kPa), indicating extremely high flow resistance. At or shortly after injection stops, the pressure curve shows a rapid and steep drop Kdown, with the pressure value quickly falling back. This is because the injected liquid pressure dissolves the blockage clots, suddenly reducing the flow resistance.

[0075] Algorithm logic: IF(Fstatus==NORMAL)AND(Kup is very high)AND(Pmax is very high)AND(Kdown exists in a rapid descent segment)THEN status = "The ductal obstruction has been cleared or can be cleared".

[0076] System output: "Suspected blockage signal detected, partially cleared. Formal therapeutic flushing recommended." It also provides an option to start the flushing with a single button.

[0077] Case C: The diagnosis is "catheter tip is stuck to the wall or poorly positioned".

[0078] Signal manifestations: The mechanical signal F(t) may be normal or slightly abnormal. The pressure curve shows that the pressure P(t) rises very slowly during injection, and the Pmax value reached is very low (<3kPa), or the pressure hardly changes at all. This is because the side hole at the catheter tip is tightly covered by tissue, and the injected fluid cannot effectively enter the pocket space, or it immediately diffuses from the subcutaneous tissue gap after entering, failing to establish pressure.

[0079] Algorithm logic: IF (Pmax is very low) AND (Kup is extremely low) THEN state = "The flow guide is stuck to the wall or the flow is not smooth".

[0080] System output: "The catheter tip may be stuck to the wall. Try gently rotating or fine-tuning the position of the extracorporeal segment of the catheter within the allowable range of the buffer base, and then reassess." This guides healthcare professionals to make the most targeted physical adjustments.

[0081] Case D: Determined as "catheter dislodgement".

[0082] Signal manifestations: The mechanical signal F(t) is abnormal, characterized by extremely low Fcurrent, approaching zero (below Fthresholdlow), i.e., "force signal disappears." The pressure curve shows similar characteristics to case C, with no pressure change or minimal change. This is because the catheter may no longer be within the pouch, and the injected fluid flows directly into the subcutaneous tissue or outside the body.

[0083] Algorithm logic: IF(Fstatus==ABNORMALLOW)AND(P response is weak)THEN status=“Catheter may have dislodged, please check immediately!”

[0084] System output: Triggers a high-level alarm, displaying and sounding: "Warning! Catheter mechanical signal disappears, suspected dislodgement! Please immediately check the puncture site and catheter fixation!"

[0085] Through the above diagnostic process, the system transforms the vague phenomenon of "stopping the flow" into a clear and directional judgment based on objective physical signals, greatly improving the scientific nature and accuracy of nursing decisions.

[0086] Step 4: Closed-loop safety irrigation treatment.

[0087] If the intelligent diagnosis determines the situation as B (blockage), or if the doctor decides to flush based on clinical experience, the closed flushing procedure can be initiated. After confirming that the flushing fluid source 27 is connected correctly, the medical staff clicks "Closed Fluid Fluid" on the interactive display interface. The system first ensures that the multi-functional switching valve 19 is in the second working state. Then, the main controller 2 controls the micro-fluid pump 4 to operate at the set treatment flow rate (e.g., 5-10 ml / min). The flushing fluid (physiological saline) is pumped out from the flushing fluid source 27, flows through the micro-fluid pump 4 and the micro-tube 25, enters the side wall micro-tube 8 of the integrated dual-channel guide tube 6, and finally flows out from the distal lateral outflow hole 11. Since the lateral outflow hole 11 is located inside the pocket and is independent of the main flow chamber 9, the flushing fluid is directly delivered to the target area to locally flush and dilute the blood clot. The fluid mixed with blood and clots is in the pocket, and then enters the main flow chamber 9 through the large-area porous guide section 10 on the main tube body 7. At this point, because the first pipeline interface 20 is connected to a pressure relief valve or the atmosphere (or connected to a very low negative pressure) through the pressure monitoring chamber 29, the flushing mixture can flow out naturally under gravity or extremely low negative pressure, and is led to the waste liquid bag through the main pipeline 24. Throughout the flushing process, the main negative pressure passage (miniature negative pressure pump 3) and the flushing injection passage are mechanically separated, and the system has no open connection points with the external environment, achieving true "closed-loop" operation and minimizing exogenous contamination. The flushing volume and speed can be controlled by a program, and the pressure sensor 30 continuously monitors during the flushing process to prevent excessive pressure inside the bag.

[0088] Step 5: Continuous monitoring and dynamic protection during detention.

[0089] Throughout the catheter placement period (typically 24-72 hours), the device provides continuous intelligent protection. The universal damping joint 15 of the cushioned fixation base 12 is always in use. When the patient turns over, coughs, or takes a deep breath, the relative movement between the skin and subcutaneous tissue generates lateral forces on the catheter. Traditional rigid fixation would transmit this force directly to the catheter tip within the pocket, potentially causing pain or tissue damage. In this device, however, the force first causes a slight deflection of the catheter locking member 14 relative to the adhesive base plate 13, and the viscoelastic damping material 17 deforms to absorb energy, thereby converting the sharp impact force into a gentle, slow displacement, significantly reducing the peak stress transmitted to the tip within the body. The flexible pressure-sensing membrane 18 acts like a sensitive "tactile nerve," continuously feeding back this mechanical interaction signal to the main controller 2. The system can learn and establish a mechanical baseline for the patient in a resting state. Any abnormal, persistent increase in tension (which may mean the catheter is caught on clothing or the patient is in a particular position causing continuous traction) will be identified and alerted, reminding healthcare personnel or the patient to make adjustments.

[0090] Step Six: Remove the tube.

[0091] When the drainage fluid significantly decreases and becomes clear, and the intelligent diagnostic system indicates that the bag is empty, and the doctor's assessment confirms that the catheter can be removed, the catheter can be removed. Clicking "Stop Drainage" on the interactive display will cause the main controller 2 to first shut down the micro negative pressure pump 3, and then control the multi-functional switching valve 19 to switch to the third working state (closed position), closing all tubing. Subsequently, loosen the catheter locking piece 14 on the buffer fixing base 12, gently lift it from the adhesive base plate 13, and finally smoothly pull the integrated dual-channel drainage catheter 6 out of the bag. The entire process does not require disconnecting complex tubing connections, simplifying the process and reducing contamination.

[0092] The intelligent pocket drainage and fixation device for cardiovascular surgery provided in this embodiment achieves the following outstanding technical effects through the detailed structural design and workflow described above: First, the device innovatively adopts a co-extruded integrated dual-channel catheter structure, seamlessly integrating an independent flushing microchannel on the basis of a single-lumen catheter. This achieves physical isolation between the flushing fluid and the main drainage pathway, making safe and convenient closed-loop flushing possible and completely avoiding the risk of contamination caused by disconnection during traditional flushing, thus improving operational safety. Second, the device pioneered an active buffer fixation base with integrated mechanical sensing, innovating traditional static rigid fixation into dynamic and perceptible flexible fixation. Its universal damping joint can effectively absorb the relative displacement energy between tissue and skin caused by patient movement, buffering the harmful shear force between the catheter tip and the healing tissue, greatly improving patient comfort and potentially reducing tissue trauma. At the same time, the built-in flexible pressure sensing film can quantify the force state of the catheter in real time, providing the system with direct mechanical dimension information to determine whether the catheter has shifted, folded, or been abnormally pulled, achieving a leap from "blind fixation" to "sensing and buffering in tandem." Finally, the core intelligence of the device lies in its state diagnostic algorithm based on multi-source signal fusion. The system controls a multi-functional switching valve and a micro-fluid pump to perform standard micro-fluid stimulation tests, simultaneously acquiring high-precision fluid pressure response curves and real-time catheter tension data. By extracting characteristic parameters such as the upward slope, peak value, plateau phase, and downward trend of the pressure curve, and cross-validating them with the tension baseline, the system can reliably distinguish four clinically significant states: "fluid drainage," "tubal blockage," "catheter apposition," and "catheter dislodgement." It provides clear conclusions to guide medical staff in taking precise measures, transforming postoperative drainage management from an experience-based, somewhat vague art to a data-driven, precise science, significantly reducing the risk of complications and improving nursing efficiency and quality. In summary, this device is a systematic solution integrating structural innovation, intelligent diagnosis, and human-centered design, providing high-level support for the critical rehabilitation phase after cardiovascular implantation.

[0093] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A cardiovascular postoperative catheter adaptive fixation and closed-loop flushing device, characterized in that: It includes an external control unit, an integrated dual-channel flow catheter, a buffer fixation base with integrated mechanical monitoring, and a multi-functional switching valve; The main controller, micro negative pressure pump and micro flushing pump are fixedly installed inside the housing of the external control host, and the surface of the housing of the external control host is provided with a display interface. The integrated dual-channel flow guide includes a main body and sidewall microtubes. The main body has a main flow cavity inside, and the distal sidewall of the main body has a porous flow guide section that communicates with the main flow cavity. The sidewall microtubes are co-extruded and completely embedded in the tube wall of the main body during the manufacturing process, and the sidewall microtubes have independent lateral outflow holes at the distal end of the main body. The integrated mechanical monitoring buffer fixation base includes an adhesive base plate, a catheter locking component, and a universal damping joint. The lower surface of the adhesive base plate is covered with a medical adhesive layer. The lower end of the universal damping joint is fixedly connected to the adhesive base plate, and the upper end of the universal damping joint is fixedly connected to the catheter locking component. The interior of the universal damping joint is filled with a viscoelastic damping material, and a flexible pressure sensing film is integrated into the viscoelastic damping material. The multi-functional switching valve is provided with a first pipeline interface, a second pipeline interface and a third pipeline interface on its valve body, and a valve core drive module is movably arranged inside the valve body. The proximal end of the integrated dual-channel flow guide tube is connected to the first pipeline interface of the multi-functional switching valve through the main pipeline, and the proximal end of the sidewall microtube is directly connected to the outlet of the micro flushing pump through the micro pipeline. The inlet of the miniature negative pressure pump is connected to the second pipeline interface of the multi-functional switching valve via a negative pressure pipeline; The inlet of the miniature flushing pump is connected to a flushing fluid source; The main controller is electrically connected to the flexible pressure sensing membrane, the valve core drive module, the micro negative pressure pump, the micro flushing pump, and the display interface via control circuits.

2. The cardiovascular postoperative catheter adaptive fixation and closed-loop flushing device according to claim 1, characterized in that: The universal damping joint allows the conduit locking member to make small, damped, multi-directional deflections relative to the adhesive base plate.

3. The cardiovascular postoperative catheter adaptive fixation and closed-loop flushing device according to claim 1, characterized in that: The valve core drive module of the multi-functional switching valve can move within the valve body to switch between different fluid passage states; the different fluid passage states include at least a first state in which the first pipeline interface is connected to the second pipeline interface, and a second state in which the first pipeline interface is connected to a pressure monitoring chamber and the third pipeline interface is connected to the micro flushing pump.

4. The cardiovascular postoperative catheter adaptive fixation and closed-loop flushing device according to claim 3, characterized in that: The device also includes a pressure sensor, the detection end of which is connected to the pressure monitoring chamber, and the signal output end of which is connected to the main controller.

5. The cardiovascular postoperative catheter adaptive fixation and closed-loop flushing device according to claim 4, characterized in that: The main controller is configured to execute a status diagnostic program; the status diagnostic program includes: controlling the valve core drive module to switch to the second state, and controlling the micro flushing pump to inject a quantitative amount of liquid into the target area through the micro-tube and the side wall micro-tube, while acquiring pressure change data of the proximal end of the main flow chamber through the pressure sensor.

6. The cardiovascular postoperative catheter adaptive fixation and closed-loop flushing device according to claim 5, characterized in that: During the execution of the state diagnostic procedure, the main controller synchronously acquires the mechanical baseline data monitored by the flexible pressure sensing film.

7. The cardiovascular postoperative catheter adaptive fixation and closed-loop flushing device according to claim 1, characterized in that: The sidewall microtube has a bypass pressure relief structure on the section near its proximal end, which is separated from the main flow cavity by a selected permeable material.

8. The cardiovascular postoperative catheter adaptive fixation and closed-loop flushing device according to claim 1, characterized in that: The device also includes a wireless communication module, which is connected to the main controller and is used to transmit system operating status, alarm information or operation logs to an external terminal.

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