CN108525101A - A kind of Portable thoracic cavity drainage tube and its moulding process - Google Patents
A kind of Portable thoracic cavity drainage tube and its moulding process Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0056—Catheters; Hollow probes characterised by structural features provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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Abstract
Description
技术领域technical field
本发明涉及一种引流装置,具体涉及一种便携式胸腔引流管及其成型工艺。The invention relates to a drainage device, in particular to a portable chest drainage tube and its forming process.
背景技术Background technique
气体进入胸膜腔,造成积气状态,称为气胸,可以自发地发生,也可由于疾病、外伤、手术或诊断及治疗性操作不当等引起。气体通过胸壁、横膈、纵膈或脏层胸膜进入胸膜腔。胸膜腔内有气体往往提示胸膜腔与外界之间(通过颈部或胸壁),或胸膜腔与邻近空腔脏器(如肺、气管、支气管、食管或膈下空腔脏器)间有异常通道。Gas enters the pleural cavity, resulting in a pneumothorax, a state called pneumothorax, which can occur spontaneously or as a result of disease, trauma, surgery, or improper diagnostic and therapeutic procedures. Air enters the pleural cavity through the chest wall, diaphragm, mediastinum, or visceral pleura. Air in the pleural cavity often indicates an abnormality between the pleural cavity and the outside world (through the neck or chest wall), or between the pleural cavity and adjacent hollow viscera (eg, lungs, trachea, bronchi, esophagus, or subdiaphragmatic hollow viscera) aisle.
气胸常见的临床分类有以下三种:(1)闭合性气胸,肺压缩<20%者,单纯卧床休闲气胸即可自行吸收,肺压缩>20%症状明显者应胸腔穿刺抽气1/1~2d次,每次600~800ml为宜;(2)开放性气胸,应用胸腔闭式引流排气,肺扔不能复张者,可加用负压持续吸引;(3)张力性气胸,病情较危急须尽快排气减压,同时准备立即行胸腔闭式引流或负压持续吸引。There are three common clinical classifications of pneumothorax: (1) Closed pneumothorax, if the lung compression is less than 20%, the pneumothorax can be self-absorbed by simply resting in bed, and if the lung compression is more than 20%, the symptom should be 1/1 to thoracentesis 2 days, 600-800ml each time is appropriate; (2) open pneumothorax, use closed thoracic drainage to exhaust, if the lungs cannot be re-expanded, continuous suction with negative pressure can be added; (3) tension pneumothorax, the condition is more severe In case of emergency, it is necessary to exhaust and decompress as soon as possible, and at the same time, prepare for immediate chest drainage or continuous negative pressure suction.
胸腔减压治疗是气胸的主要治疗方法,胸腔闭式引流是将引流管一端放入胸腔内,而另一端接入比其位置更低的水封瓶,以便排出气体或收集胸腔内的液体,使得肺组织重新张开而恢复功能。胸腔减压治疗作为一种治疗手段广泛地应用于血胸、气胸、脓胸的引流及开胸术后。常见的胸腔闭式引流系统及原理如图1~图3所示。Chest decompression therapy is the main treatment method for pneumothorax. Closed chest drainage is to put one end of the drainage tube into the chest cavity, and the other end is connected to a water-sealed bottle lower than its position, so as to discharge gas or collect fluid in the chest cavity. This allows lung tissue to reopen and restore function. Chest decompression therapy as a treatment method is widely used in the drainage of hemothorax, pneumothorax, empyema and after thoracotomy. Common closed chest drainage systems and their principles are shown in Figures 1 to 3.
胸腔闭式引流系统的出现,使气胸患者的紧急救治更加快捷高效,但是该引流装置一般仅限于院内治疗使用,使用期间显著地限制了患者的活动。在临床中我们常遇到一些患者经积极胸腔闭式引流后病情持续不能好转,常见于有阻塞性肺气肿、肺功能极差的老人,此类患者即使肺压缩仅20%~30%时也有明显呼吸困难,长期的慢性炎症、反复的感染致使胸膜黏连,在用力动作如抬重物、咳嗽、喷嚏、屏气或高喊大笑等诱因下,很多靠近胸膜的多发肺大泡破裂可致使顽固性气胸,破口愈合效果差、病程长、外科手术困难、住院费用高、经济负担重。The emergence of closed thoracic drainage system has made the emergency treatment of pneumothorax patients faster and more efficient, but the drainage device is generally limited to hospital use, which significantly limits the patient's activities during use. In clinical practice, we often encounter some patients whose condition continues to fail to improve after active closed thoracic drainage. It is common in elderly people with obstructive emphysema and extremely poor lung function. Even when the lung compression is only 20% to 30% in such patients There are also obvious dyspnea, long-term chronic inflammation, repeated infection lead to pleural adhesions, and many multiple bullae near the pleura may rupture under incentives such as lifting heavy objects, coughing, sneezing, holding your breath, or shouting and laughing. Lead to refractory pneumothorax, poor wound healing effect, long course of disease, difficult surgery, high hospitalization costs, and heavy economic burden.
发明内容Contents of the invention
本发明要解决的技术问题是提供一种便携式胸腔引流管及其成型工艺,利用PES滤过膜隔离空气中的细菌,避免胸腔与外界大气直接相通,减少感染机会,可以明显减少患者住院时间、减少患者使用抗生素使用时间,对提高患者远期生存率均有很大的效益,同时可以显著改善患者生活质量。The technical problem to be solved by the present invention is to provide a portable chest drainage tube and its molding process, which uses the PES filter membrane to isolate bacteria in the air, avoids the direct communication between the chest cavity and the outside atmosphere, reduces the chance of infection, and can significantly reduce the hospitalization time of patients. Reducing the time of patients using antibiotics is of great benefit to improving the long-term survival rate of patients, and can significantly improve the quality of life of patients.
为解决上述技术问题,本发明提供一种便携式胸腔引流管,包括引流管、尾端接头、塑料外管、胶皮弹力膜管芯、头端接头和过滤器,其中,In order to solve the above-mentioned technical problems, the present invention provides a portable chest drainage tube, comprising a drainage tube, a tail end joint, a plastic outer tube, a rubber elastic membrane tube core, a head end joint and a filter, wherein,
所述引流管的一端连接患者胸膜腔的引流管,另一端与尾端接头相连;One end of the drainage tube is connected to the drainage tube of the patient's pleural cavity, and the other end is connected to the tail end connector;
所述尾端接头的远离引流管的一端插入塑料外管内;One end of the tail joint away from the drainage tube is inserted into the plastic outer tube;
所述胶皮弹力膜管芯设于塑料外管内,其为一端圆形口、一端鸭嘴口的鸭嘴状结构,所述胶皮弹力膜管芯的圆形口与尾端接头连接,所述胶皮弹力膜管芯的鸭嘴口延伸至塑料外管的内顶下方;The rubber elastic film tube core is arranged in the plastic outer tube, which is a duckbill-shaped structure with a round mouth at one end and a duckbill mouth at one end. The round mouth of the rubber elastic film tube core is connected to the tail end joint, and the rubber elastic film tube core The duckbill of the elastic film tube core extends below the inner top of the plastic outer tube;
所述头端接头由头端盘底和头端连接管一体成型,所述塑料外管的顶端上开设有孔,所述头端连接管自孔向外伸出,所述头端盘底卡设于塑料外管的内侧;The head-end connector is integrally formed by the bottom of the head-end plate and the head-end connecting pipe. A hole is opened on the top of the plastic outer pipe. The head-end connecting pipe protrudes outward from the hole. The head-end plate bottom is clamped on the inner side of the plastic outer tube;
所述过滤器包括下连接管、过滤本体和上连接管,所述下连接管与头端连接管密封连接,所述过滤本体内设有PES滤过膜,所述PES滤过膜上分布有微米级过滤孔;The filter includes a lower connecting pipe, a filter body and an upper connecting pipe, the lower connecting pipe is in sealing connection with the head-end connecting pipe, the filter body is provided with a PES filter membrane, and the PES filter membrane is distributed with Micron filter holes;
所述引流管、尾端接头的管腔、胶皮弹力膜管芯的管腔、头端接头的管腔、下连接管的管腔、微米级过滤孔以及上连接管的管腔连通,形成单向引流通道。The drainage tube, the lumen of the tail end joint, the lumen of the rubber elastic film tube core, the lumen of the head end joint, the lumen of the lower connecting tube, the micron filter hole and the lumen of the upper connecting tube are connected to form a single to the drainage channel.
其中,所述胶皮弹力膜管芯的外径自圆形口往鸭嘴口逐渐缩小,所述胶皮弹力膜管芯的外壁与塑料外管的内壁之间存有间隙。Wherein, the outer diameter of the rubber elastic film tube core gradually decreases from the circular mouth to the duckbill mouth, and there is a gap between the outer wall of the rubber elastic film tube core and the inner wall of the plastic outer tube.
优选的,所述尾端接头由细圆管段、倒锥形段和粗圆管段从下往上一体连接而成,所述倒锥形段的外锥面上设有斜翅,所述粗圆管段的下端、倒锥形段和细圆管段位于塑料外管的下方,所述粗圆管段的上端插入塑料外管内。Preferably, the tail end joint is integrally connected from bottom to top by a thin circular pipe section, an inverted conical section and a thick circular pipe section, the outer tapered surface of the inverted tapered section is provided with oblique fins, and the thick circular pipe section The lower end of the pipe section, the inverted tapered section and the thin round pipe section are located below the plastic outer pipe, and the upper end of the thick round pipe section is inserted into the plastic outer pipe.
进一步,所述塑料外管的底端密封连接有端盖,所述端盖上设有安装孔,所述尾端接头与安装孔密封连接。Further, the bottom end of the plastic outer tube is sealingly connected with an end cover, and the end cover is provided with a mounting hole, and the tail end joint is sealingly connected with the mounting hole.
其中,所述上连接管与注射器或负压引流设备连接。Wherein, the upper connecting tube is connected with a syringe or a negative pressure drainage device.
优选的,所述过滤本体内为扁圆形空腔,所述PES滤过膜铺设于扁圆形空腔内,且PES滤过膜的圆边与扁圆形空腔的内侧壁焊接。Preferably, the inside of the filter body is an oblate cavity, the PES filter membrane is laid in the oblate cavity, and the round edge of the PES filter membrane is welded to the inner side wall of the oblate cavity.
进一步,所述过滤本体包括与下连接管一体成型的扁圆形壳体、与上连接管一体成型的锥形壳盖,所述PES滤过膜铺设于扁圆形壳体内,所述锥形壳盖密封盖设于扁圆形壳体的上方。Further, the filter body includes an oblate shell integrally formed with the lower connecting pipe, and a conical shell cover integrally formed with the upper connecting pipe, the PES filter membrane is laid in the oblate shell, and the conical The shell cover sealing cover is arranged on the top of the oblate shell.
本发明还提供一种便携式胸腔引流管的成型工艺,包括如下步骤:The present invention also provides a molding process of a portable chest drainage tube, comprising the following steps:
(1)加工塑料外管:利用聚丙烯材料、无机抗菌剂、增塑剂、稳定剂、抗冲击改性剂制备医用抗菌性塑料颗粒,然后将医用抗菌性塑料颗粒置于注塑机内分别注塑成型圆筒状的塑料外管、端盖;(1) Processing plastic outer tube: use polypropylene material, inorganic antibacterial agent, plasticizer, stabilizer, impact modifier to prepare medical antibacterial plastic granules, and then place medical antibacterial plastic granules in the injection molding machine for injection molding Forming cylindrical plastic outer tubes and end caps;
(2)制备胶皮弹力膜管芯:将乳胶溶液置于吹塑机内吹塑成型胶皮弹力膜管芯的毛坯,然后将胶皮弹力膜管芯的毛坯的顶端切除,形成鸭嘴口,底端开圆形口,制成一端圆形口、一端鸭嘴口的胶皮弹力膜管芯;(2) Preparation of the rubber elastic film tube core: put the latex solution in the blow molding machine to blow mold the blank of the rubber elastic film tube core, then cut off the top of the rubber elastic film tube core blank to form a duckbill mouth, the bottom end Open a round mouth to make a rubber elastic film tube core with a round mouth at one end and a duckbill mouth at one end;
(3)加工过滤本体:利用聚丙烯材料、无机抗菌剂、增塑剂、稳定剂、抗冲击改性剂制备医用抗菌性塑料颗粒,然后将医用抗菌性塑料颗粒置于注塑机内分别注塑成型下连接管和扁圆形壳体连接的一体式结构、上连接管和锥形盖连接的一体式结构;(3) Process and filter the body: use polypropylene materials, inorganic antibacterial agents, plasticizers, stabilizers, and impact modifiers to prepare medical antibacterial plastic particles, and then place the medical antibacterial plastic particles in the injection molding machine for injection molding An integrated structure connecting the lower connecting pipe and the oblate shell, and an integrated structure connecting the upper connecting pipe and the conical cover;
(4)裁剪PES滤过膜,PES滤过膜的外径不小于步骤(3)制得的扁圆形壳体的内径,然后在PES滤过膜上冲出多个微米级过滤孔,用于过滤气体和液体中的细菌;(4) Cut the PES filter membrane, the outer diameter of the PES filter membrane is not less than the inner diameter of the oblate shell obtained in step (3), and then punch out multiple micron-scale filter holes on the PES filter membrane, and use For filtering bacteria in gases and liquids;
(5)将步骤(4)中加工后的PES滤过膜的外缘与扁圆形壳体的内壁面热塑性焊接,且保证焊缝处密封;(5) thermoplastically welding the outer edge of the PES filter membrane processed in step (4) to the inner wall surface of the oblate shell, and ensuring that the weld seam is sealed;
(6)注塑成型尾端接头和头端接头;(6) Injection molding tail end connector and head end connector;
(7)组装:(7) Assembly:
(7-1)头端接头的头端连接管自塑料外管顶端上的孔向外伸出,头端接头的头端盘底卡设于塑料外管的内侧,头端接头与塑料外管的连接处密封;(7-1) The head-end connecting tube of the head-end joint protrudes outward from the hole on the top of the plastic outer tube, and the head-end disc bottom of the head-end joint is set on the inner side of the plastic outer tube, and the head-end joint and the plastic outer tube The joints are sealed;
(7-2)尾端接头与端盖连接,并保证连接处密封;(7-2) The tail end joint is connected with the end cover, and the connection is guaranteed to be sealed;
(7-3)胶皮弹力膜管芯的圆形口端与尾端接头的粗圆管段固定、密封连接;(7-3) The round mouth end of the rubber elastic film tube core is fixed and sealed with the thick round pipe section of the end joint;
(7-4)步骤(7-3)中携带尾端接头和胶皮弹力膜管芯的端盖与塑料外管的底端密封连接,使胶皮弹力膜管芯置于塑料外管内且胶皮弹力膜管芯的上端位于塑料外管的内顶下方,胶皮弹力膜管芯的外壁与塑料外管的内壁之间存有间隙;(7-4) In step (7-3), the end cap carrying the tail joint and the rubber elastic film core is sealed and connected to the bottom end of the plastic outer tube, so that the rubber elastic film core is placed in the plastic outer tube and the rubber elastic film The upper end of the tube core is located below the inner top of the plastic outer tube, and there is a gap between the outer wall of the rubber elastic film tube core and the inner wall of the plastic outer tube;
(7-5)头端接头的头端连接管与下连接管插接,过滤本体的内腔通过下连接管的管腔和头端连接管的管腔与塑料外管的内腔连通,便携式胸腔引流管组装完成;(7-5) The head-end connecting tube of the head-end connector is inserted into the lower connecting tube, and the inner cavity of the filter body communicates with the inner cavity of the plastic outer tube through the lumen of the lower connecting tube and the lumen of the head-end connecting tube. Portable The chest drainage tube is assembled;
(7-6)便携式胸腔引流管组装完成后经高温消毒灭菌处理,保证胸腔引流管无菌化。(7-6) After the portable chest drainage tube is assembled, it is sterilized by high temperature to ensure the asepticity of the chest drainage tube.
其中,所述步骤(1)中,医用抗菌性塑料颗粒的制备包括如下步骤:Wherein, in the step (1), the preparation of medical antibacterial plastic particles includes the following steps:
(1-1)将100重量份聚丙烯材料、0.1~5重量份无机抗菌剂、30~50重量份增塑剂、2~5重量份稳定剂、10~30重量份抗冲击改性剂按比例混合均匀,制成复合材料;(1-1) 100 parts by weight of polypropylene material, 0.1 to 5 parts by weight of inorganic antibacterial agent, 30 to 50 parts by weight of plasticizer, 2 to 5 parts by weight of stabilizer, and 10 to 30 parts by weight of impact modifier The proportion is mixed evenly to make a composite material;
(1-2)将复合材料置于塑料挤出机内,在150~180℃温度下挤出并用切粒机切粒,得到医用抗菌性塑料颗粒。(1-2) Put the composite material in a plastic extruder, extrude it at a temperature of 150-180°C and cut it into pellets with a pelletizer to obtain medical antibacterial plastic pellets.
本发明的上述技术方案的有益效果如下:本发明中PES滤过膜隔离空气中的细菌,避免胸腔与外界大气直接相通,减少感染机会,可以明显减少患者住院时间、减少患者使用抗生素时间,对提高患者远期生存率有很大的效益,同时不影响患者一般的生活活动,可以显著改善患者的生活质量。本发明适用于顽固性交通性气胸稳定期患者,此外还适用于需要反复多次抽气的单纯性气胸患者,减少反复穿刺的组织损伤及其他穿刺并发症。The beneficial effects of the above-mentioned technical solution of the present invention are as follows: in the present invention, the PES filter membrane isolates the bacteria in the air, avoids direct communication between the chest cavity and the outside atmosphere, reduces the chance of infection, can significantly reduce the hospitalization time of the patient, and reduce the time for the patient to use antibiotics. Improving the long-term survival rate of patients has great benefits, and at the same time does not affect the general life activities of patients, which can significantly improve the quality of life of patients. The invention is suitable for patients with intractable communicating pneumothorax in the stable stage, and also suitable for patients with simple pneumothorax who need repeated air pumping, reducing tissue damage and other puncture complications caused by repeated punctures.
附图说明Description of drawings
图1为本发明背景技术中现有的单瓶胸腔闭式引流系统及原理图;Fig. 1 is the existing single-bottle chest cavity drainage system and schematic diagram in the background technology of the present invention;
图2为本发明背景技术中现有的双瓶胸腔闭式引流系统及原理图;Fig. 2 is the existing two-bottle chest cavity drainage system and schematic diagram in the background technology of the present invention;
图3为本发明背景技术中现有的三瓶胸腔闭式引流系统及原理图;Fig. 3 is the existing three-bottle thoracic closed drainage system and schematic diagram in the background technology of the present invention;
图4为本发明实施例一的主视图;Fig. 4 is the front view of Embodiment 1 of the present invention;
图5为本发明实施例一的剖视图;Figure 5 is a sectional view of Embodiment 1 of the present invention;
图6为实施例一中PES滤过膜的结构示意图。Fig. 6 is a schematic structural view of the PES filter membrane in Example 1.
附图标记说明:Explanation of reference signs:
1、引流管;2、尾端接头;20、细圆管段;21、倒锥形段;22、粗圆管段;3、塑料外管;4、胶皮弹力膜管芯;5、头端接头;50、头端盘底;51、头端连接管;6、过滤器;60、下连接管;61、过滤本体;62、上连接管;7、PES滤过膜;70、微米级过滤孔;8、端盖。1. Drainage tube; 2. Tail end joint; 20. Thin round tube section; 21. Inverted tapered section; 22. Thick round tube section; 3. Plastic outer tube; 4. Rubber elastic film tube core; 5. Head end joint; 50. Head end plate bottom; 51. Head end connecting pipe; 6. Filter; 60. Lower connecting pipe; 61. Filtration body; 62. Upper connecting pipe; 7. PES filter membrane; 70. Micron filter hole; 8. End cap.
具体实施方式Detailed ways
为使本发明要解决的技术问题、技术方案和优点更加清楚,下面将结合附图及具体实施例进行详细描述。In order to make the technical problems, technical solutions and advantages to be solved by the present invention clearer, the following will describe in detail with reference to the drawings and specific embodiments.
如图4、图5所示,本发明提供一种便携式胸腔引流管,包括引流管1、尾端接头2、塑料外管3、胶皮弹力膜管芯4、头端接头5和过滤器6,其中,As shown in Fig. 4 and Fig. 5, the present invention provides a portable chest drainage tube, comprising a drainage tube 1, a tail end connector 2, a plastic outer tube 3, a rubber elastic film tube core 4, a head end connector 5 and a filter 6, in,
所述引流管1的一端连接患者胸膜腔的引流管,另一端与尾端接头2相连;其中,尾端接头2可以直接或经不同尺寸的转接头间接地与不同孔径的引流管连接,方便引流。One end of the drainage tube 1 is connected to the drainage tube of the patient's pleural cavity, and the other end is connected to the tail end connector 2; wherein, the tail end connector 2 can be directly or indirectly connected to drainage tubes of different apertures through adapters of different sizes, which is convenient drainage.
所述尾端接头2的远离引流管1的一端插入塑料外管3内;One end of the tail joint 2 away from the drainage tube 1 is inserted into the plastic outer tube 3;
所述胶皮弹力膜管芯4设于塑料外管3内,其为一端圆形口、一端鸭嘴口的鸭嘴状结构,所述胶皮弹力膜管芯4的圆形口与尾端接头2连接,所述胶皮弹力膜管芯4的鸭嘴口延伸至塑料外管3的内顶下方;The rubber elastic film tube core 4 is arranged in the plastic outer tube 3, which is a duckbill-shaped structure with a round mouth at one end and a duckbill mouth at one end. connected, the duckbill mouth of the rubber elastic film tube core 4 extends to the bottom of the inner top of the plastic outer tube 3;
所述头端接头5由头端盘底50和头端连接管51一体成型,所述塑料外管3的顶端上开设有孔(光孔或者螺纹孔),所述头端连接管51自孔向外伸出,所述头端盘底50卡设于塑料外管3的内侧;The head-end joint 5 is integrally formed by the head-end pan bottom 50 and the head-end connecting pipe 51, and a hole (light hole or threaded hole) is opened on the top of the plastic outer tube 3, and the head-end connecting pipe 51 is formed from the hole to the protruding outward, the head end disc bottom 50 is clamped on the inner side of the plastic outer tube 3;
所述过滤器6包括下连接管60、过滤本体61和上连接管62,所述下连接管60与头端连接管51密封连接(可以是直接插接,也可以螺纹连接),所述过滤本体61内设有PES滤过膜7,所述PES滤过膜7上分布有微米级过滤孔70,微米级过滤孔70的孔径0.22μm,可滤过细菌,如图6所示,所述上连接管62可与注射器连接或外接负压设备。The filter 6 includes a lower connecting pipe 60, a filter body 61 and an upper connecting pipe 62. The lower connecting pipe 60 is tightly connected to the head-end connecting pipe 51 (it can be directly inserted or screwed), and the filter The body 61 is provided with a PES filter membrane 7, and the PES filter membrane 7 is distributed with micron filter holes 70, the pore diameter of the micron filter holes 70 is 0.22 μm, which can filter bacteria, as shown in Figure 6, the The upper connecting pipe 62 can be connected with a syringe or externally connected with negative pressure equipment.
所述引流管1、尾端接头2的管腔、胶皮弹力膜管芯4的管腔、头端接头5的管腔、下连接管60的管腔、微米级过滤孔70以及上连接管62的管腔连通,形成单向引流通道,单向的意思为:气体或液体可以自引流管向过滤器方向流动,但不可以自过滤器向引流管方向流动,因为当有气体或液体自过滤器进入后,胶皮弹力膜管芯的鸭嘴口会关闭,阻止气体或液体进入患者胸腔。The drainage tube 1, the lumen of the tail end joint 2, the lumen of the rubber elastic film tube core 4, the lumen of the head end joint 5, the lumen of the lower connecting pipe 60, the micron filter hole 70 and the upper connecting pipe 62 The lumen of the tube is connected to form a one-way drainage channel. One-way means: gas or liquid can flow from the drainage tube to the filter direction, but cannot flow from the filter to the drainage tube direction, because when there is gas or liquid self-filtering After the device enters, the duckbill mouth of the rubber elastic membrane tube core will be closed to prevent gas or liquid from entering the patient's chest cavity.
所述胶皮弹力膜管芯4的外径自圆形口往鸭嘴口逐渐缩小,所述胶皮弹力膜管芯4的外壁与塑料外管3的内壁之间存有间隙。The outer diameter of the rubber elastic film tube core 4 gradually decreases from the circular mouth to the duckbill mouth, and there is a gap between the outer wall of the rubber elastic film tube core 4 and the inner wall of the plastic outer tube 3 .
所述尾端接头2由细圆管段20、倒锥形段21和粗圆管段22从下往上一体连接而成,所述倒锥形段21的外锥面上设有斜翅,所述粗圆管段22的下端、倒锥形段21和细圆管段20位于塑料外管3的下方,所述粗圆管段22的上端插入塑料外管3内。The tail joint 2 is integrally connected from bottom to top by a thin round pipe section 20, an inverted tapered section 21 and a thick round pipe section 22. The outer tapered surface of the inverted tapered section 21 is provided with oblique fins. The lower end of the thick round tube section 22 , the inverted tapered section 21 and the thin round tube section 20 are located below the plastic outer tube 3 , and the upper end of the thick round tube section 22 is inserted into the plastic outer tube 3 .
所述塑料外管3的底端密封连接有端盖8,所述端盖8上设有安装孔,所述尾端接头2与安装孔密封连接。The bottom end of the plastic outer tube 3 is sealed and connected with an end cap 8, and the end cap 8 is provided with a mounting hole, and the tail end joint 2 is sealed and connected with the mounting hole.
所述过滤本体61内为扁圆形空腔,所述PES滤过膜7铺设于扁圆形空腔内,且PES滤过膜7的外缘与扁圆形空腔的内侧壁焊接。The inside of the filter body 61 is an oblate cavity, the PES filter membrane 7 is laid in the oblate cavity, and the outer edge of the PES filter membrane 7 is welded to the inner wall of the oblate cavity.
本实施例中,所述过滤本体61包括与下连接管60一体成型的扁圆形壳体、与上连接管62一体成型的锥形壳盖,所述PES滤过膜7铺设于扁圆形壳体内,所述锥形壳盖密封盖设于扁圆形壳体的上方。In this embodiment, the filter body 61 includes an oblate shell integrally formed with the lower connecting pipe 60, and a conical shell cover integrally formed with the upper connecting pipe 62, and the PES filter membrane 7 is laid on the oblate shell. In the casing, the conical casing cover sealing cover is arranged above the oblate casing.
本发明还提供一种便携式胸腔引流管的成型工艺,包括如下步骤:The present invention also provides a molding process of a portable chest drainage tube, comprising the following steps:
(1)加工塑料外管:利用聚丙烯材料、无机抗菌剂、增塑剂、稳定剂、抗冲击改性剂制备医用抗菌性塑料颗粒,然后将医用抗菌性塑料颗粒置于注塑机内分别注塑成型圆筒状的塑料外管、端盖;(1) Processing plastic outer tube: use polypropylene material, inorganic antibacterial agent, plasticizer, stabilizer, impact modifier to prepare medical antibacterial plastic granules, and then place medical antibacterial plastic granules in the injection molding machine for injection molding Forming cylindrical plastic outer tubes and end caps;
其中,医用抗菌性塑料颗粒的制备包括如下步骤:Wherein, the preparation of medical antibacterial plastic particles comprises the following steps:
(1-1)将100重量份聚丙烯材料、0.1~5重量份无机抗菌剂、30~50重量份增塑剂、2~5重量份稳定剂、10~30重量份抗冲击改性剂按比例混合均匀,制成复合材料;(1-1) 100 parts by weight of polypropylene material, 0.1 to 5 parts by weight of inorganic antibacterial agent, 30 to 50 parts by weight of plasticizer, 2 to 5 parts by weight of stabilizer, and 10 to 30 parts by weight of impact modifier The proportion is mixed evenly to make a composite material;
(1-2)将复合材料置于塑料挤出机内,在150~180℃温度下挤出并用切粒机切粒,得到医用抗菌性塑料颗粒。(1-2) Put the composite material in a plastic extruder, extrude it at a temperature of 150-180°C and cut it into pellets with a pelletizer to obtain medical antibacterial plastic pellets.
(2)制备胶皮弹力膜管芯:将乳胶溶液置于吹塑机内吹塑成型胶皮弹力膜管芯的毛坯,然后将胶皮弹力膜管芯的毛坯的顶端切除,形成鸭嘴口,底端开圆形口,制成一端圆形口、一端鸭嘴口的胶皮弹力膜管芯;(2) Preparation of the rubber elastic film tube core: put the latex solution in the blow molding machine to blow mold the blank of the rubber elastic film tube core, then cut off the top of the rubber elastic film tube core blank to form a duckbill mouth, the bottom end Open a round mouth to make a rubber elastic film tube core with a round mouth at one end and a duckbill mouth at one end;
(3)加工过滤本体:利用聚丙烯材料、无机抗菌剂、增塑剂、稳定剂、抗冲击改性剂制备医用抗菌性塑料颗粒,然后将医用抗菌性塑料颗粒置于注塑机内分别注塑成型下连接管和扁圆形壳体连接的一体式结构、上连接管和锥形盖连接的一体式结构;(3) Process and filter the body: use polypropylene materials, inorganic antibacterial agents, plasticizers, stabilizers, and impact modifiers to prepare medical antibacterial plastic particles, and then place the medical antibacterial plastic particles in the injection molding machine for injection molding An integrated structure connecting the lower connecting pipe and the oblate shell, and an integrated structure connecting the upper connecting pipe and the conical cover;
(4)裁剪PES滤过膜,PES滤过膜的外径不小于步骤(3)制得的扁圆形壳体的内径,然后在PES滤过膜上冲出多个微米级过滤孔,用于过滤气体或液体中的细菌;(4) Cut the PES filter membrane, the outer diameter of the PES filter membrane is not less than the inner diameter of the oblate shell obtained in step (3), and then punch out multiple micron-scale filter holes on the PES filter membrane, and use For filtering bacteria in gas or liquid;
(5)将步骤(4)中加工后的PES滤过膜的外缘与扁圆形壳体的内壁面热塑性焊接,且保证焊缝处密封;(5) thermoplastically welding the outer edge of the PES filter membrane processed in step (4) to the inner wall surface of the oblate shell, and ensuring that the weld seam is sealed;
(6)注塑成型尾端接头和头端接头;(6) Injection molding tail end connector and head end connector;
(7)组装:(7) Assembly:
(7-1)头端接头的头端连接管自塑料外管顶端上的孔向外伸出,头端接头的头端盘底卡设于塑料外管的内侧,头端接头与塑料外管的连接处密封;(7-1) The head-end connecting tube of the head-end joint protrudes outward from the hole on the top of the plastic outer tube, and the head-end disc bottom of the head-end joint is set on the inner side of the plastic outer tube, and the head-end joint and the plastic outer tube The joints are sealed;
(7-2)尾端接头与端盖连接,并保证连接处密封;(7-2) The tail end joint is connected with the end cover, and the connection is guaranteed to be sealed;
(7-3)胶皮弹力膜管芯的圆形口端与尾端接头的粗圆管段固定、密封连接;(7-3) The round mouth end of the rubber elastic film tube core is fixed and sealed with the thick round pipe section of the end joint;
(7-4)步骤(7-3)中携带尾端接头和胶皮弹力膜管芯的端盖与塑料外管的底端密封连接,使胶皮弹力膜管芯置于塑料外管内且胶皮弹力膜管芯的上端位于塑料外管的内顶下方,胶皮弹力膜管芯的外壁与塑料外管的内壁之间存有间隙;(7-4) In step (7-3), the end cap carrying the tail joint and the rubber elastic film core is sealed and connected to the bottom end of the plastic outer tube, so that the rubber elastic film core is placed in the plastic outer tube and the rubber elastic film The upper end of the tube core is located below the inner top of the plastic outer tube, and there is a gap between the outer wall of the rubber elastic film tube core and the inner wall of the plastic outer tube;
(7-5)头端接头的头端连接管与下连接管插接,过滤本体的内腔通过下连接管的管腔和头端连接管的管腔与塑料外管的内腔连通,便携式胸腔引流管组装完成;(7-5) The head-end connecting tube of the head-end connector is inserted into the lower connecting tube, and the inner cavity of the filter body communicates with the inner cavity of the plastic outer tube through the lumen of the lower connecting tube and the lumen of the head-end connecting tube. Portable The chest drainage tube is assembled;
(7-6)便携式胸腔引流管组装完成后经高温消毒灭菌处理,保证胸腔引流管无菌化。(7-6) After the portable chest drainage tube is assembled, it is sterilized by high temperature to ensure the asepticity of the chest drainage tube.
上述组装过程中,各零件之间的连接处,为达到密封效果,可选择性地使用丁基橡胶密封圈。In the above assembly process, butyl rubber sealing rings can be optionally used at the joints between the parts in order to achieve a sealing effect.
以上完成便携式胸腔引流管的装置成型、装配和消毒,用于临床使用。The device molding, assembly and sterilization of the portable chest drainage tube are completed above for clinical use.
临床使用时,将尾端接头的细圆管段与置于患者胸膜腔的引流管插接,完成便携式引流排气的目的,或外接注射器、负压引流设备,完成液体的单向引流。过滤器若出现阻塞、引流不畅,可单独更换。In clinical use, the thin round tube section of the tail end connector is inserted into the drainage tube placed in the patient's pleural cavity to complete the purpose of portable drainage and exhaust, or an external syringe or negative pressure drainage device is connected to complete the one-way drainage of liquid. If the filter is clogged and the drainage is not smooth, it can be replaced separately.
本发明的工作原理为:患者胸腔内的气体或液体经由引流管1、尾端接头2的管腔、胶皮弹力膜管芯4的管腔、头端接头5的管腔、下连接管60的管腔、微米级过滤孔70以及上连接管62的管腔,在与上连接管62连接的注射器或外界负压机构的吸引作用下引流出患者体外,本发明的引流通道为单向通道,单向的意思为:气体或液体可以自引流管向过滤器方向流动,但不可以自过滤器向引流管方向流动,因为当有气体或液体自过滤器进入后,胶皮弹力膜管芯的鸭嘴口会关闭,阻止气体或液体进入患者胸腔。The working principle of the present invention is: the gas or liquid in the patient's thoracic cavity passes through the drainage tube 1, the lumen of the tail end joint 2, the lumen of the rubber elastic membrane tube core 4, the lumen of the head end joint 5, and the lumen of the lower connecting tube 60. The lumen, the micron filter hole 70 and the lumen of the upper connecting tube 62 are drained out of the patient's body under the suction of the syringe connected to the upper connecting tube 62 or the external negative pressure mechanism. The drainage channel of the present invention is a one-way channel. One-way means: gas or liquid can flow from the drainage tube to the filter direction, but cannot flow from the filter to the drainage tube direction, because when gas or liquid enters from the filter, the duck of the rubber elastic film core The mouth will close, preventing air or liquid from entering the patient's chest cavity.
本发明中PES滤过膜隔离空气中的细菌,避免胸腔与外界大气直接相通,减少感染机会,可以明显减少患者住院时间、减少患者使用抗生素使用时间,对提高患者远期生存率均有很大的效益,同时可以显著改善患者生活质量。本发明适用于顽固性交通性气胸稳定期患者,此外还适用于需要反复多次抽气单纯式气胸患者,减少患者痛苦,减少穿刺痛苦及组织损伤。In the present invention, the PES filter membrane isolates the bacteria in the air, avoids the direct communication between the chest cavity and the outside atmosphere, reduces the chance of infection, can significantly reduce the hospitalization time of patients, reduce the use time of antibiotics for patients, and greatly improve the long-term survival rate of patients. It can also significantly improve the quality of life of patients. The present invention is suitable for patients with intractable communicating pneumothorax in the stable stage, and also suitable for patients with simple pneumothorax who need to repeatedly pump air, reducing the pain of patients, puncture pain and tissue damage.
以上所述是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明所述原理的前提下,还可以作出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。The above description is a preferred embodiment of the present invention, it should be pointed out that for those of ordinary skill in the art, without departing from the principle of the present invention, some improvements and modifications can also be made, and these improvements and modifications can also be made. It should be regarded as the protection scope of the present invention.
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