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CN-122005968-A - Drainage and administration integrated system for malignant pleural effusion and control method thereof

CN122005968ACN 122005968 ACN122005968 ACN 122005968ACN-122005968-A

Abstract

The invention discloses a drainage and administration integrated system for malignant pleural effusion and a control method thereof, which comprise a catheter assembly, wherein the catheter assembly comprises a catheter body, one end of the catheter body is a chest end, the other end of the catheter body is an external end, an inner cavity of the catheter body is divided into a drainage cavity, an administration cavity and a sampling cavity, an external connection unit comprises a drainage device, an administration device and a sampler, the drainage device is communicated with the drainage cavity through the drainage tube to form a drainage loop, the administration device is communicated with the administration cavity through the administration tube to form an administration loop, the sampler is communicated with the sampling cavity through the sampling tube to form a sampling loop, the valve control assembly comprises a drainage valve on the drainage loop, an administration valve on the administration loop and a sampling valve on the sampling loop, and the monitoring assembly comprises a monitoring controller, and is communicated with the valve control assembly to switch the drainage loop, the administration loop or the sampling loop, and is electrically connected with the administration device to regulate and control the administration amount. The invention can realize drainage, administration and sampling of pleural effusion on the premise of not disconnecting the pipeline.

Inventors

  • LIU YAN
  • DING HAIFENG
  • LIANG MAOQUAN

Assignees

  • 东莞市东南部中心医院(东莞市东南部中医医疗服务中心、广东医科大学附属东莞第一医院)

Dates

Publication Date
20260512
Application Date
20260316

Claims (10)

  1. 1. A drainage and administration integrated system for malignant pleural effusion, comprising: The catheter assembly (2), the catheter assembly (2) comprises a tube body (21), wherein one end of the tube body (21) is a chest end, and the other end of the tube body is an external end, and the inner cavity of the tube body (21) is divided into a drainage cavity (22), a drug administration cavity (23) and a sampling cavity (24) which are isolated from each other through an inner ridge (25); The external connection unit comprises a drainage device (4), a drug feeder (5) and a sampler (6), wherein the drainage device (4) is communicated with the drainage cavity (22) through a drainage tube (41) to form a drainage loop, the drug feeder (5) is communicated with the drug feeding cavity (23) through a drug feeding tube (51) to form a drug feeding loop, and the sampler (6) is communicated with the sampling cavity (24) through a sampling tube (61) to form a sampling loop; a valve control assembly (3), the valve control assembly (3) comprising a drain valve (31) provided on the drain flow circuit, a dosing valve (32) provided on the dosing circuit, and a sampling valve (33) provided on the sampling circuit; The monitoring assembly (8), the monitoring assembly (8) comprises a monitoring controller (83), the monitoring controller (83) is in communication connection with the valve control assembly (3) to switch on-off of the drainage loop, the drug administration loop or the sampling loop, and the monitoring controller (83) is electrically connected with the drug administration device (5) to regulate and control the drug administration amount.
  2. 2. The drainage and administration integrated system for malignant pleural effusion according to claim 1, wherein the monitoring assembly (8) further comprises a pressure sensor (81) and a flow sensor (82), the pressure sensor (81) is arranged at the outer end of the tube body (21) to monitor the pressure in the chest cavity or the pipeline, the flow sensor (82) is arranged on the drainage loop to monitor drainage flow, and the pressure sensor (81) and the flow sensor (82) are both in communication connection with the monitoring controller (83) to conduct data interaction.
  3. 3. The drainage and administration integrated system for malignant pleural effusion according to claim 2, characterized in that the monitoring controller (83) is configured to control the opening and closing of the drainage valve (31), the administration valve (32) and the sampling valve (33) to switch the system among a drainage mode, an administration mode and a sampling mode according to detection signals of the pressure sensor (81) and/or the flow sensor (82), and to perform pinching or flow-limiting control of a drainage circuit in the drainage mode in the administration mode.
  4. 4. The drainage and administration integrated system for malignant pleural effusion according to claim 1, characterized in that the valve control assembly (3) further comprises a one-way valve (34) arranged on the drainage loop, and the one-way valve (34) is arranged between the drainage valve (31) and the drainage device (4).
  5. 5. The drainage and administration integrated system for malignant pleural effusion of claim 1, wherein one end of the drainage tube (41) far away from the drainage device (4) is a drainage interface, one end of the administration tube (51) far away from the administration device (5) is an administration interface, one end of the sampling tube (61) far away from the sampler (6) is a sampling interface, and the drainage interface, the administration interface and the sampling interface are special-shaped interfaces with different forms.
  6. 6. The drainage and administration integrated system for malignant pleural effusion according to claim 1, characterized in that the catheter assembly (2) further comprises a puncture cannula (26), the puncture cannula (26) being coaxially sleeved and fixed on the outer circumference of the tube body (21).
  7. 7. The drainage and administration integrated system for malignant pleural effusion of claim 6, wherein one end of the puncture cannula (26) corresponding to the pleural end is provided with a developing mark or a developing line, and the outer wall of the puncture cannula (26) is provided with scale marks.
  8. 8. The drainage and administration integrated system for malignant pleural effusion according to claim 7, wherein the drainage cavity (22), the administration cavity (23) and the sampling cavity (24) are provided with a plurality of side holes corresponding to the cavity walls of the pleural cavity end.
  9. 9. The drainage and administration integrated system for malignant pleural effusion according to claim 1, further comprising a control host (7), wherein the control host (7) is electrically connected with the monitoring controller (83) for parameter setting, status display, alarm prompt and process recording.
  10. 10. A control method of a drainage and administration integrated system for malignant pleural effusion according to any one of claims 1 to 9, characterized by comprising the steps of: s1, drainage control, namely conducting a drainage loop and a drainage cavity to close an administration loop and a sampling loop, and conducting drainage of pleural effusion; s2, after receiving an administration instruction, the monitoring controller detects whether chest pressure is in a preset safety interval, whether a drainage loop is clamped and has no continuous negative pressure, and whether the pipeline connection is correct, and only when all the conditions are met, the administration controller is allowed to enter an administration mode; S3, accurately feeding, namely closing a drainage loop, opening a feeding loop, controlling the medicine to be infused into the chest according to the preset dosage and flow rate, and dynamically adjusting the infusion rate according to chest pressure feedback; s4, entering a residence stage after the drug administration is finished, maintaining the drainage loop to be clamped for a preset residence time, monitoring the chest pressure in real time during the residence time, and gradually recovering drainage according to a preset strategy after the residence is finished; s5, closing the drug administration loop and opening the sampling loop under the condition of not interrupting the drainage loop, sampling the pleural effusion, and recovering the isolation state of the sampling cavity after the sampling is completed; S6, pulse flushing is carried out on the pipeline through the drug delivery loop.

Description

Drainage and administration integrated system for malignant pleural effusion and control method thereof Technical Field The invention relates to the technical field of medical equipment, in particular to a drainage and administration integrated system for malignant pleural effusion and a control method thereof. Background Malignant pleural effusion (MALIGNANT PLEURAL EFFUSION, MPE) is a common complication of chest malignancies (e.g., lung cancer, pleural mesothelioma, breast cancer metastasis, etc.), with varying degrees of pleural effusion occurring in about 50% of advanced lung cancer patients. Along with the progress of the disease, the pleural effusion is rapidly increased, which often causes symptoms such as progressive dyspnea, chest pain, cough and the like, and seriously affects the life quality and the life cycle of patients. At present, the treatment of malignant pleural effusion mainly comprises repeated thoracocentesis drainage, closed thoracic drainage, pleurodesis, intrathoracic drug treatment and the like. Wherein, the closed thoracic drainage is a basic means for relieving dyspnea symptoms, and the retention of effusion is continuously or intermittently drained through the indwelling drainage tube so as to relieve lung tissue compression. In recent years, with the development of immunotherapy, treatment strategies such as intrathoracic local perfusion immune checkpoint inhibitors (such as PD-1/PD-L1 inhibitors), cytokines or biological response modifiers have shown good prospects in the comprehensive treatment of malignant pleural effusions, and can effectively control effusion generation and improve prognosis. However, in current clinical practice, chest drainage and intrathoracic administration typically employ separate or temporarily spliced modes of operation. Specifically, a single-cavity or simple double-cavity intrathoracic drain is used for drainage, a closed drainage bottle or a negative pressure suction device is connected, and the drainage connection is disconnected for administration, and medicines are injected through the drainage tube or by other puncture. This "split" operation has the following technical drawbacks: First, risk of infection and handling contamination problems. The drainage pipeline is frequently disconnected to carry out the administration operation, so that the pipeline interface is exposed to the external environment, the risks of bacterial invasion and cross contamination are increased, meanwhile, the drainage system is required to be reconnected after administration, the tightness is difficult to maintain, and the phenomena of backflow and suck-back are easy to occur. Second, the pipeline is misconnected and the potential safety hazard is operated. The drainage system and the drug delivery system interface have high standardization degree but lack of an anti-misconnection structure, and risk of misconnection of the drainage interface to the drug delivery device or misconvergence of the drug into the drainage loop exists, so that serious complications such as drug waste, dose error or pneumothorax can be caused. Third, chest pressure is out of control and the safety of administration is inadequate. The prior administration operation lacks a linkage control mechanism with chest pressure and drainage state. In the process of drug administration, if the drainage loop continues negative pressure suction, the drug can be sucked out after not fully acting on the pleural cavity, and the drainage tube is not clamped in time after drug administration, the liquid medicine can flow back to the drainage bottle along with the body position change. In addition, intrathoracic administration may cause pulmonary edema or a stenotic lung injury if the chest cavity is under high negative pressure. Fourth, the functional integration level is low and the process is difficult to trace. The existing drainage tube is of a single-cavity structure, multiple requirements of drainage, drug administration, sampling, flushing and the like cannot be met at the same time, consumable materials are required to be replaced for many times in clinical operation, and pain and medical cost of a patient are increased. Meanwhile, the lack of accurate monitoring and recording means for the dosage, the dosage rate, the residence time and the drainage quantity is unfavorable for the standardized formulation and the curative effect evaluation of the treatment scheme. Fifth, a safety interlock mechanism is lacking. The prior art does not automatically judge and limit the administration condition, can not ensure that the drainage tube is in a safe clamping state and chest pressure is in a reasonable interval before administration, and also lacks the functions of real-time monitoring and automatic protection for abnormal conditions such as blockage, leakage, backflow and the like. In summary, in the prior art, in drainage and local administration treatment of malignant pleural effusion, the technical pr