Disposable 700ml limited type puncture drainage bag special for pleural effusion

Abstract

The invention discloses a disposable 700ml limited type puncture drainage bag special for pleural effusion, belongs to the field of clinical medical instruments, and is particularly suitable for drainage of tuberculous pleural effusion and cancerous pleural effusion in a tuberculosis high-incidence area and emergency treatment of war wounds. According to the drainage bag, a special thoracocentesis assembly, an integrated flow control drainage hose and a disposable 700ml pre-filled negative pressure suction bottle are integrated into a sterile integrated kit, the special thoracocentesis assembly comprises a puncture needle with a side hole and a graduated drainage catheter, the middle section of the drainage hose is provided with an integrated buckle clamp, 700ml graduation lines are calibrated by the suction bottle, negative pressure of-0.04 MPa to-0.06 MPa is pre-filled, and the disposable 700ml pre-filled negative pressure suction bottle is provided with a drainage tube. Seamless butt joint is achieved through a Luer taper. The disposable design completely eradicates mycobacterium tuberculosis cross infection, rapid butt joint adapts to battle wound first aid, multi-time flow control meets the cancerous hydrothorax treatment requirement, additional transfer is not needed, unpacking and instant use are achieved, operation is convenient, safety is high, cost is low, and the device is suitable for all levels of medical institutions, grassroots units, field first aid and other scenes and has wide application prospects. The kit is especially suitable for large-scale clinical application in tuberculosis high-incidence areas, and the popularization value is remarkable.

Description

Technical Field

[0001] This invention relates to the field of clinical medical device technology, specifically to a disposable 700ml limited-volume pleural effusion puncture and drainage kit, which is particularly suitable for clinical drainage of tuberculous pleural effusion and tumor-related malignant pleural effusion in areas with a high incidence of tuberculosis, as well as for rapid treatment of pleural effusion in combat trauma emergency care. Background Technology

[0002] Pleural effusion is a common clinical condition. In areas with a high incidence of tuberculosis, the incidence of tuberculous pleural effusion and tuberculous peritonitis complicated with pleural effusion remains high. Simultaneously, with the increasing incidence of tumors, the clinical need for malignant pleural effusion is growing. Furthermore, in wartime trauma scenarios, effusion caused by pleural injury requires rapid drainage to save lives. Current drainage methods mostly employ a combination of a central venous catheter and an independent negative pressure suction bottle, which has the following key drawbacks: Poor adaptability: There is no special design for tuberculosis, cancer and war trauma scenarios. Reusing equipment in tuberculosis drainage can easily lead to cross-infection. In war trauma emergency care, additional transfer parts are required, which delays rescue time. Insufficient safety: Reusable negative pressure suction bottles are not thoroughly disinfected, which can easily lead to the spread of infectious bacteria such as Mycobacterium tuberculosis; malignant pleural effusion requires multiple drainages, and existing equipment is cumbersome to operate and has inaccurate flow control; High operational threshold: In primary healthcare institutions and field emergency rescue scenarios, medical staff need to be proficient in operations such as transfer and negative pressure aspiration, which makes it difficult to respond quickly; Cost mismatch: In primary healthcare institutions and war trauma emergency supplies reserves, the procurement and maintenance costs of existing equipment are high, making it difficult to equip them on a large scale.

[0003] A search revealed that existing similar patents (such as CN223627602U, CN223208479U, and CN214232247U) do not cover the combination adaptation of the above three scenarios, and do not achieve integrated aseptic packaging of "puncture + flow control + negative pressure suction". They still have problems such as cumbersome operation, low flow control accuracy, and high risk of cross-infection. Therefore, there is an urgent need for an integrated puncture and drainage solution that adapts to the specific pain points in clinical practice and is both safe and convenient. Summary of the Invention

[0004] 1. Purpose of the invention This invention provides a disposable 700ml limited-volume pleural effusion puncture and drainage kit, which addresses the clinical needs of high-incidence tuberculosis areas, the characteristics of malignant pleural effusion treatment, and the timeliness requirements of combat trauma emergency care. It achieves the core objectives of "ready to use after unpacking, precise flow control, sterile safety, and economic adaptability," reducing the operational threshold and medical costs. It is suitable for various scenarios such as medical institutions at all levels, primary health units, and field emergency care, and especially meets the needs of infectious disease prevention and control and large-scale clinical application in high-incidence tuberculosis areas.

[0005] The present invention relates to a disposable 700ml limited-volume pleural effusion puncture and drainage kit, comprising a sterile-sealed dedicated puncture component, a drainage control component, and a disposable 700ml pre-filled negative pressure suction bottle, which are pre-assembled into an integrated kit, with the specific structure as follows: (1) Special puncture kit: including a 16G / 18G thoracentesis needle with side hole (to reduce pleural damage and be suitable for gentle drainage of tuberculous and cancerous effusions and rapid puncture for combat trauma), a 50cm long guide wire with a blunt tip (to avoid vascular damage and improve the safety of combat trauma emergency treatment), a medical soft PVC dilator (to reduce the risk of tissue tearing and be suitable for weak tuberculous patients and trauma patients), a drainage catheter with side hole and scale (30cm long, 1cm precision scale, to facilitate catheter placement for multiple drainage of cancerous pleural effusions), and pre-packaged sterile cotton pads, medical gloves, fixation tape, gauze, tourniquet and other auxiliary accessories to meet the requirements of aseptic operation.

[0006] (2) Drainage and flow control components: including a 20cm long medical sterile silicone drainage tube, one end of which is fixedly connected to the drainage catheter, and the other end is equipped with a Luer connector (no additional adapter required, suitable for rapid docking in combat trauma emergency); the middle section of the tube is equipped with an integrated snap-on tube clamp, which can be operated with one hand to clamp / release, realize drainage start and stop and flow control, and meet the clinical needs of multiple drainage of cancerous pleural effusion and multiple drainage of tuberculous effusion.

[0007] (3) Disposable 700ml pre-filled negative pressure suction bottle: medical transparent PP material, the bottle body is marked with a red thickened 700ml scale line (precise flow control to avoid excessive drainage and complications), pre-filled with -0.04~-0.06MPa negative pressure (gentle drainage, suitable for the tolerance of tuberculosis patients, tumor patients and trauma patients), the bottle mouth Luer mother head is seamlessly connected to the drainage tube, the bottom is non-slip (suitable for bumpy environments in field emergency rescue), and the top is equipped with a negative pressure indicator valve (quickly judge the drainage status and improve emergency rescue efficiency). The disposable design prevents cross-infection of infectious bacteria such as Mycobacterium tuberculosis.

[0008] Step 1: Unpack and check the sterility and expiration date (in combat trauma scenarios, unpacking can be done quickly without additional preparation). Step 2: Disinfect the puncture site with built-in sterile cotton pads, put on gloves, apply a tourniquet, and complete the thoracentesis through the puncture needle (strict aseptic operation is required for tuberculosis patients; this procedure uses disposable components to avoid cross-infection), and introduce the guidewire; Step 3: Insert the dilation tube along the guidewire, replace the drainage catheter (control the depth according to the tube wall markings to adapt to the insertion accuracy requirements of multiple drainage of malignant pleural effusion), and fix it with a fixation tape; Step 4: Connect the drainage tube Luer connector to the negative pressure suction bottle (no adapter required; connection can be completed within 10 seconds in a war trauma scenario), and release the clamp to start drainage; Step 5: When the effusion approaches the 700ml mark, clamp the tube to stop drainage (tuberculous or cancerous effusions need to be drained in stages to avoid re-expansion pulmonary edema; in combat trauma scenarios, the suction bottle can be quickly replaced for continuous drainage). Step 6: After drainage is completed, remove the catheter and apply gauze to stop the bleeding (disposable components are treated as medical waste; tuberculosis patients can be sealed and discarded directly after drainage to reduce the risk of infection).

[0009] (1) Precise adaptation to scenarios: The disposable sterile design eliminates cross-infection of Mycobacterium tuberculosis and is adapted to the clinical needs of high-incidence areas of tuberculosis; the multiple start-stop flow control function meets the requirements of multiple drainage of cancerous pleural effusion; the quick docking and ready-to-use design is adapted to the timeliness of emergency treatment for combat trauma. (2) Safe and controllable: 700ml limit + double flow control with tubing clamp to avoid complications from excessive drainage, suitable for the physical tolerance of weak tuberculosis patients, tumor patients and trauma patients; (3) Easy to operate: The pre-assembled kit does not require additional transfer, and grassroots medical staff and emergency personnel can quickly get started, which can shorten the preparation time for rescue in combat trauma scenarios; (4) Economical and practical: low-cost medical materials are mass-produced with low unit price, which is suitable for the needs of primary medical institutions, large-scale procurement in areas with high incidence of tuberculosis, and the reserve of war trauma emergency supplies; (5) Infection control: After single use, it can be sealed and discarded directly without disinfection, reducing the risk of transmission of infectious diseases such as tuberculosis and reducing the disinfection burden on medical staff. Attached Figure Description Figure 1 Schematic diagram of the overall packaging of a disposable puncture drainage pack Labels: Sterile aluminum foil packaging bag (labeled "single use", "sterile", "700ml limit", "expiration date", "sterilization mark", "suitable for tuberculosis / cancer / war trauma drainage"), internal component distribution (puncture needle, guide wire, drainage catheter, suction bottle, auxiliary accessories), internal components are indicated by dotted lines. Figure 2 Schematic diagram of the unfolded components of the special puncture kit Note: Puncture needle with side hole, guide wire, dilator, graduated drainage catheter, pre-connected drainage tubing, integrated tubing clamp, Luer connector, sterile cotton pads, medical gloves, fixation tape, gauze, tourniquet (labeled "sterile disposable components to prevent cross-infection"). Figure 3 Schematic diagram of a disposable 700ml negative pressure suction bottle Notes: Medical PP bottle body, 700ml red graduation line, negative pressure indicator valve (green / red marking), sealed Luer female head, non-slip bottom (front view + top view, marked "pre-filled negative pressure, no additional operation required"). Figure 4 Overall usage status diagram Labels: Human chest cavity (puncture site), drainage catheter placement position, integrated drainage tubing, tubing clamp (loose state), Luer connector connection, disposable negative pressure suction bottle (with effusion illustration), labeled "Suitable for tuberculous effusion / malignant pleural effusion / battle trauma emergency care".

Claims

1. Disposable 700ml limited-volume pleural effusion drainage kit: The disposable 700ml limited-volume pleural effusion drainage kit is characterized by: The kit includes a sterile ethylene oxide-sterilized and aluminum foil-sealed puncture assembly, a drainage control assembly, and a disposable 700ml pre-filled negative pressure suction bottle. These three components are pre-assembled into a single sterile kit, ready for immediate use upon unpacking. All components are designed for single use and are disposed of as medical waste after use. It is suitable for drainage of tuberculous pleural effusion in high-incidence areas of tuberculosis, staged drainage of cancerous pleural effusion in oncology departments, and rapid drainage of pleural effusion in emergency trauma care. The puncture assembly, drainage control assembly, and disposable 700ml pre-filled negative pressure suction bottle connect seamlessly via Luer connectors, requiring no additional adapters. The drainage control assembly and the disposable 700ml pre-filled negative pressure suction bottle work together to achieve a limited, dual-flow control of 700ml. The disposable 700ml pre-filled negative pressure suction bottle has a fixed-volume structure, and the pre-filled negative pressure eliminates the need for additional clinical aspiration, preventing cross-infection of Mycobacterium tuberculosis at the source.

2. The puncture drainage pack according to claim 1, characterized in that: The dedicated puncture assembly includes a 16G / 18G thoracentesis needle with side holes, a 50cm long guide wire with a blunt tip, a medical soft PVC dilator adapted to the puncture needle specifications, a 30cm long drainage catheter with side holes marked with 1cm precision on the tube wall, and pre-packaged sterile cotton pads, medical gloves, fixation tape, gauze, and tourniquet. The side holes of the drainage catheter are evenly distributed within 5cm of the catheter tip, and the guide wire has a blunt tip structure to avoid damage to blood vessels / pleura.

3. The puncture drainage pack according to claim 1, characterized in that: The drainage and flow control assembly includes a 20cm long medical sterile silicone drainage tube and an integrated snap-on tube clamp. One end of the drainage tube is fixedly connected to the drainage catheter, and the other end is fixedly connected to a Luer male connector. The integrated snap-on tube clamp is integrally formed with the drainage tube and is located in the middle section of the drainage tube. The opening and closing angle of the clamp is ≥90°, which can be operated with one hand to achieve complete clamping and quick release of the drainage channel, realizing the start and stop of drainage and flow control.

4. The puncture drainage pack according to claim 1, characterized in that: The disposable 700ml pre-filled negative pressure suction bottle is made of medical-grade transparent PP plastic. The bottle body is marked with a red bold 700ml limit mark. The bottle is pre-filled with a mild negative pressure of -0.04~-0.06MPa. It is sealed with negative pressure before leaving the factory and there is no leakage of negative pressure during the shelf life.

5. The puncture drainage pack according to claim 1 or 4, characterized in that: The disposable 700ml pre-filled negative pressure suction bottle has a sealed Luer female connector at the bottle mouth, which can be seamlessly plugged into and unplugged with the Luer male connector of the drainage tube. The connection is leak-proof. The bottom of the suction bottle has anti-slip texture and the top has a negative pressure indicator valve. The negative pressure indicator valve is marked with green and red. Green indicates that the negative pressure is normal and drainage is possible, while red indicates that the negative pressure is ineffective and drainage is not possible.

6. The puncture drainage pack according to claim 1, characterized in that: The 700ml limited flow control system combines graduated line flow control with snap-clamp flow control. When the fluid in the suction bottle reaches the 700ml mark, the drainage channel can be quickly closed with the snap-clamp to stop drainage, avoiding excessive drainage that could cause re-expansion pulmonary edema. This system is suitable for the physical tolerance of frail tuberculosis patients, cancer patients, and war trauma patients.

7. The puncture drainage pack according to claim 1, characterized in that: The integrated sterile kit's aluminum foil packaging bag is marked with a sterilization symbol, expiration date, production date, and a scenario label indicating "suitable for tuberculosis / cancer / combat trauma pleural effusion drainage." The packaging bag measures 25cm × 15cm × 8cm, facilitating storage, transportation, and carrying of combat trauma emergency supplies.

8. The puncture drainage pack according to claim 1, characterized in that: The total length of the connection between the dedicated puncture component, the drainage and flow control component and the disposable 700ml pre-filled negative pressure suction bottle is 70cm, which is suitable for the space requirements of different operation scenarios such as bedside drainage and field emergency rescue.

9. The puncture drainage pack according to claim 1, characterized in that: The disposable 700ml pre-filled negative pressure suction bottle has a volume error of ≤±5ml and a marking error of ≤±1mm for the 700ml scale line, ensuring the accuracy of clinical drainage dosage.

10. The puncture drainage pack according to claim 1, characterized in that: The integrated snap-on hose clamp is made of medical-grade ABS material. It leaves no liquid residue when clamped, is resistant to low and high temperatures, and is suitable for the complex environment of field trauma emergency treatment. It can be repeatedly started and stopped without structural damage, meeting the clinical needs of multiple drainage sessions for cancerous pleural effusion.

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