WO2021022725A1 - 一种软头可调鼻咽通气管 - Google Patents

一种软头可调鼻咽通气管 Download PDF

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Publication number
WO2021022725A1
WO2021022725A1 PCT/CN2019/121476 CN2019121476W WO2021022725A1 WO 2021022725 A1 WO2021022725 A1 WO 2021022725A1 CN 2019121476 W CN2019121476 W CN 2019121476W WO 2021022725 A1 WO2021022725 A1 WO 2021022725A1
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Prior art keywords
tube
soft
nasopharyngeal
joint
monitoring catheter
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PCT/CN2019/121476
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English (en)
French (fr)
Inventor
邹德伟
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天津美迪斯医疗用品有限公司
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Priority claimed from CN201921241486.2U external-priority patent/CN211188657U/zh
Priority claimed from CN201910710955.9A external-priority patent/CN110496285A/zh
Application filed by 天津美迪斯医疗用品有限公司 filed Critical 天津美迪斯医疗用品有限公司
Publication of WO2021022725A1 publication Critical patent/WO2021022725A1/zh

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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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits

Definitions

  • the invention belongs to the technical field of medical devices, and specifically relates to a soft-head adjustable nasopharyngeal ventilation tube, which is a medical device used as an artificial airway ventilation for emergency rescue and assisted breathing or surgical anesthesia.
  • Nasopharyngeal ventilation tube is an artificial airway inserted into the pharyngeal cavity through the nose. Its function is to relieve or relieve the patient's upper airway obstruction or obstruction.
  • the nasopharyngeal vent tube is generally made of soft silicone or plastic material. It conforms to the physiological structure of the human nasopharyngeal cavity. Its structural shape is designed as an arc-shaped tube, with moderate hardness, and the length is the distance from the human nasal cavity to the oropharyngeal cavity. quite.
  • the port of the nasopharyngeal ventilation tube is an oblique mouth, which reduces friction with the nasal cavity tissue during insertion and facilitates passage through the nasal cavity.
  • the nasopharyngeal ventilation tube has received great attention from medical workers and the medical device industry because of its clinical application value, but the structure and function of the ordinary nasopharyngeal ventilation tube are simple. In recent years, in order to meet the requirements of the continuous development of the medical level, the structure of the nasopharyngeal ventilation tube has been improved day by day. The structure of the nasopharyngeal ventilation tube is reported in the following patent documents:
  • Chinese invention patent, patent number CN201320727635.2 discloses a nasopharyngeal ventilation tube with a monitoring catheter, which is composed of a connector, a bushing, a ventilation tube, a fixing piece, a monitoring catheter and a male connector.
  • the advantages of the invention 1) The independent monitoring catheter can monitor the patient's respiratory frequency, O 2 concentration and CO 2 concentration at any time, increase the humidity of the nasal mucosa, and enhance safety. 2)
  • the fixing part is used to fix the monitoring catheter so that it is not easy to slip off, and to avoid deep insertion into the patient's nasal cavity and cause injury. 3) With a rotatable multifunctional joint, it can perform operations such as oxygen infusion and sputum suction on the patient at the same time, which is safe and efficient.
  • Chinese invention patent the patent number is CN201520053161.7 (Authorization Announcement Date 20150930) discloses a nasopharyngeal ventilation tube, including a tube body, a tube joint and a three-way joint, the inner wall of the tube is attached with a traveller, and both sides of the tube body There is a pipe for sputum suction on the inside, and the pipe is connected to the position of the outlet of the pipe body.
  • the nasopharyngeal ventilation tube of the invention can not only ensure the patency of the nasopharyngeal tract, but also can effectively carry out airway care and monitor the carbon dioxide concentration, making the treatment or monitoring process more convenient, safe and effective; it can intervene in the early stage of patients with breathing difficulties It can also be applied to thoracic surgery under non-tracheal intubation anesthesia.
  • Chinese invention patent, patent number CN201710813360.7 discloses a nasopharyngeal oxygen tube, including a single nostril oxygen tube, one end of the single nostril oxygen tube is inserted into the patient’s nasopharynx through the nostril The other end is connected to the oxygen source through the connector.
  • the single nostril oxygen inhalation tube is provided with a fixing member near its insertion end. The fixing member is used to connect the single nostril oxygen inhalation tube when the insertion end is inserted into the patient’s nasopharynx. It is fixed at the patient's nostril to prevent the insertion end from sliding.
  • the invention greatly improves the concentration of oxygen inhaled by the patient by inserting the insertion end of the single nostril oxygen tube into the patient’s nasopharynx, which is more conducive to the rehabilitation of the patient.
  • a temperature sensor is provided, which can monitor the patient's nasopharyngeal temperature in real time, and has achieved the effect of detecting the patient's body temperature, reducing the patient's pain and speeding up the patient's recovery process.
  • the embodiment of the present invention discloses a nasopharyngeal ventilation duct, which includes an inflatable bag, a drug delivery bag, and a main body tube.
  • the main body tube is shaped according to the natural curvature of the nasopharyngeal airway and has an arc shape, and has a function for penetrating into the oropharynx.
  • the proximal end of the part and the distal end located outside the nasal vestibule; the main body tube has a ventilation cavity extending from the distal end to the proximal end, thereby respectively forming a distal ventilation opening and a distal ventilation opening, the inflatable bladder is arranged at the The proximal end has a cylindrical space, the inner cavity of the inflation bladder communicates with the distal inflation valve of the inflation lumen, and the proximal vent opening faces away from the axis at the proximal end of the vent cavity toward the tube body
  • the ventral side is raised to form a raised portion of the guide end of the proximal ventilation opening.
  • the nasopharyngeal ventilation duct of the present invention has the characteristics of simple structure, convenient operation and low cost, and is easy to popularize and use.
  • nasopharyngeal ventilators have the following shortcomings: (1) The oxygen supply function and the mechanical ventilation function can only achieve one of them and cannot be compatible. (2) The end-tidal CO 2 filtering cannot be achieved. The accuracy of CO 2 concentration monitoring cannot be guaranteed. (3) The hardness of the tube body is a whole section, which cannot meet the needs of patients; the material is soft, which is easy to cause difficulty in intubation and insufficient ventilation, and the material is hard, which easily causes damage and bleeding of the nasal mucosa. 4) The oblique angle of the head of the ventilation tube is designed with a pointed tip, and the intubation is easy to cause damage and bleeding of the nasal mucosa. 5) The insertion depth of the ventilation tube cannot be effectively controlled, which may cause discomfort or insufficient ventilation for the patient. (6) Some patented products contain metal materials and do not support intraoperative MRI inspection.
  • the purpose of the present invention is to provide a soft-head adjustable nasopharyngeal ventilation tube, the structure of which is composed of a flexible joint, a vent tube, an adjustable positioning ring, an air source joint, a rotary joint, a fixing part, a monitoring catheter, a male joint and a filter ,
  • the structure has a flexible rotatable joint, which can realize oxygen delivery, sputum suction and monitoring functions at the same time.
  • the air source joint can be directly connected to breathing equipment for emergency ventilation.
  • the filter can effectively filter the moisture in the patient’s exhaled air while ensuring CO 2
  • the smooth passage of the gas, the soft joint is designed to have a smooth transition at the top, and its material hardness is lower than that of the snorkel material, which can effectively protect the nasal mucosa from damage.
  • the adjustable positioning ring can adjust the position of the fixed snorkel to effectively control the insertion depth.
  • the required parts are not made of metal materials, thereby solving the above-mentioned problems in the prior art.
  • a soft-head adjustable nasopharyngeal ventilation tube including a ventilation tube, a monitoring catheter with a diameter of 2.0mm ⁇ 8.0mm and a length of 20.0cm ⁇ 50.0cm.
  • the structure is designed as two ring-shaped sleeves connected as an integral fixing part and
  • the male connector integrated with the monitoring catheter by bonding or tight fitting is characterized in that: the soft-head adjustable nasopharyngeal ventilation tube has a structure consisting of a flexible connector, a ventilation tube, an adjustable positioning ring, and an air source connector , Rotary joints, fixed parts, monitoring pipes, male joints and filters, including:
  • the structure of the soft joint is designed to connect one end to the head of the snorkel by bonding or tight fitting or welding, and the other end is designed as a segmented structure with a smooth transition at the top and an oblique structure, or a top integral with the snorkel One-piece structure with sleek transition with oblique mouth structure,
  • Ventilation tube the structure of the tube body is arc or straight, the inner diameter of the tube is 2.0mm-10.0mm, and the length is 8cm-25cm.
  • Adjustable positioning ring the structure is designed as a ring-shaped sleeve, it is set on the outer wall of the snorkel, and is preferably connected to the snorkel by a sliding fit, so that it can slide on the outer wall of the snorkel, thereby achieving the adjustable positioning function ,
  • Air supply connector one end of which is connected to the tail of the snorkel by bonding or tight fitting, and the other end is connected with the rotary joint and monitoring catheter in a tight fitting or locking manner
  • the structural shape of the rotary joint is designed as two hollow cylindrical bodies connected at a certain angle, one is connected to the oxygen pipe, and the other is connected to the gas source connector.
  • the included angle is 90° ⁇ 180°, which is tightly matched It is connected to the air source connector and can be rotated at different angles.
  • the connection between the air source connector and the air source connector is preferably separated from each other to ensure the emergency ventilation function and the oxygen supply function, monitor the patient’s respiratory frequency, O 2 Concentration and CO 2 concentration functions can be switched freely,
  • the fixed part is designed as two split ring-shaped socket fixing parts, one end of which is connected to the monitoring catheter by bonding or tight fitting, and the other end is connected with the rotary joint by bonding or tight fitting.
  • the inner diameter of the two annular cuffs is the same as the outer diameter of the monitoring catheter,
  • the monitoring catheter has a diameter of 2.0mm ⁇ 8.0mm and a length of 20.0cm ⁇ 50.0cm, which penetrates the rotary joint and the vent tube, wherein the rotary joint is connected to the monitoring catheter through a fixing member, and the monitoring catheter is at the distal end Equipped with a male connector, the male connector is connected to the monitoring catheter as a whole by bonding or tight fitting,
  • the male connector is set at the distal end of the monitoring catheter and is connected to the monitoring catheter by bonding or tight fitting as a whole,
  • the filter is connected to the male connector by locking.
  • the soft joint is made of a medical elastomeric polymer material, such as silicone rubber, or TPE (thermoplastic elastomer), or TPU (polyurethane elastomer rubber), with a Shore hardness of 10 to 45 degrees.
  • a medical elastomeric polymer material such as silicone rubber, or TPE (thermoplastic elastomer), or TPU (polyurethane elastomer rubber), with a Shore hardness of 10 to 45 degrees.
  • the vent pipe is made of medical elastomeric polymer materials, such as silicone rubber, or TPE (thermoplastic elastomer), or TPU (polyurethane elastomer rubber), with a Shore hardness of 50 to 80 degrees.
  • medical elastomeric polymer materials such as silicone rubber, or TPE (thermoplastic elastomer), or TPU (polyurethane elastomer rubber), with a Shore hardness of 50 to 80 degrees.
  • the adjustable positioning ring is made of hard medical polymer material, such as hard silicon rubber, or PC (polycarbonate), or PVC (polyvinyl chloride).
  • the fixing member and the monitoring catheter are made of medical polymer materials, such as silicone rubber, or PVC (polyvinyl chloride), or TPU (polyurethane elastomer rubber).
  • medical polymer materials such as silicone rubber, or PVC (polyvinyl chloride), or TPU (polyurethane elastomer rubber).
  • the male connector is made of rigid medical polymer materials, such as PC (polycarbonate), or PP (polypropylene), or PVC (polyvinyl chloride).
  • PC polycarbonate
  • PP polypropylene
  • PVC polyvinyl chloride
  • the gas source connector in the present invention can be directly connected to breathing equipment for mechanical ventilation, realizing emergency rescue of patients; after installing the monitoring catheter, the oxygen supply function can be realized and the respiratory frequency, O 2 concentration and CO 2 concentration of the patient can be monitored, enhancing Safety; at the same time, re-intubation is avoided, the patient's pain is reduced, the workload of medical staff before and after surgery is reduced, and the work efficiency of medical staff is improved.
  • the filter has excellent hydrophobic performance, which can not only effectively filter the moisture in the patient's exhaled air, but also ensure the smooth passage of CO 2 gas, which is beneficial to improve the accuracy of the monitoring value.
  • the head of the soft connector is soft and the arc transition is made while the tube body part maintains high hardness, which is beneficial to the smooth entry of the ventilation tube, and at the same time, avoids damaging the patient's nasal mucosa during intubation.
  • the adjustable positioning ring can adjust the position of the fixed ventilation tube, effectively control the insertion depth, and avoid insufficient ventilation and cause patient discomfort.
  • the product does not contain metal materials, which supports the MRI examination during the operation, which is convenient for the doctor to check the patient's condition in time, without repeated intubation, and relieve the patient's pain.
  • Figure 1 is a schematic diagram of the structure of the soft-head adjustable nasopharyngeal ventilation tube of the present invention
  • a soft-head adjustable nasopharyngeal ventilation tube has a structure consisting of a soft joint 1, a vent tube 2, an adjustable positioning ring 3, an air source joint 4, a rotary joint 5, and a fixing part 6.
  • the structure of the soft joint 1 is designed to connect one end to the head of the vent pipe 2 by bonding or tight fitting or welding, and the other end is designed to be a segmented structure with a smooth transition at the top and an oblique structure, or to form the vent pipe 2.
  • the integrated top smooth transition is an integrated structure with an oblique opening structure.
  • the structure of the soft joint 1 in this embodiment is designed to connect one end to the head of the vent pipe 2 in an adhesive manner, and the other end is designed as a split top transition with an oblique opening structure.
  • Ventilation tube 2 the structure of the tube body is arc or straight, the inner diameter of the tube is 2.0mm-10.0mm, the length is 8cm-25cm, the shape of this embodiment is arc, the inner diameter of the tube is 8mm, the length is 18cm,
  • the adjustable positioning ring 3 is designed in the shape of an annular sleeve, which is arranged on the outer wall of the vent tube 2, and is preferably connected to the vent tube 2 by a sliding fit, so that it can slide on the outer wall of the vent tube 2, thereby achieving Adjustable positioning function,
  • the air source connector 4 has one end connected to the tail of the vent tube 2 in a bonding or tight fitting manner, and the other end is connected to the rotary joint 5 and the monitoring catheter 7 in a tight fitting or locking manner.
  • the gas source connector 4 of this embodiment One end is tightly connected to the tail of the snorkel 2, and the other end is tightly connected to the rotary joint 5 and the monitoring catheter 7,
  • the rotary joint 5 is designed as two hollow cylindrical bodies connected at a certain angle, one is connected to the oxygen pipe, and the other is connected to the gas source connector 4.
  • the included angle is 90° ⁇ 180°.
  • the angle is designed to be 90°. It is connected to the air supply connector 4 in a tight fitting manner and can be rotated at different angles.
  • the connection between it and the air supply connector 4 is preferably designed to be separated from each other to ensure emergency ventilation Function and oxygen supply function, monitoring patient's breathing rate, O 2 concentration and CO 2 concentration function can be switched freely,
  • the structure of the fixing member 6 is designed as a split-type two ring-shaped sleeve fixing member, the inner diameters of the two ring-shaped sleeve openings are the same as the outer diameter of the monitoring catheter 7, and one end is bonded or tightly fitted with The monitoring catheter 7 is connected, and the other end is bonded or tightly fitted to the rotary joint 5.
  • the fixing member 6 of this embodiment is bonded to the monitoring catheter 7 at one end, and the other end is bonded to the rotary joint. Connector 5 connection,
  • the monitoring catheter 7 has a diameter of 2.0mm ⁇ 8.0mm and a length of 20.0cm ⁇ 50.0cm.
  • the diameter and length of the monitoring catheter 7 of this embodiment are respectively designed to be 2.5mm and 30.0cm, which penetrates the rotary joint 5 and In the vent pipe 2, the rotary joint 5 is connected to the monitoring catheter 7 through a fixing member 6.
  • a male connector 8 is provided at the distal end of the monitoring catheter 7, and the male connector 8 is connected to the monitoring catheter 7 by bonding or tight fitting. As a whole, the male connector 8 of this embodiment is connected to the monitoring catheter 7 as a whole by bonding.
  • the male connector 8 is arranged at the distal end of the monitoring catheter 7 and is connected to the monitoring catheter 7 by bonding or tight fitting.
  • the male connector 8 of this embodiment is connected to the monitoring catheter 7 by bonding.
  • the filter 9 is connected to the male connector 8 in a locking manner.
  • the soft joint 1 is made of a medical elastomeric polymer material, such as silicone rubber, or TPE (thermoplastic elastomer), or TPU (polyurethane elastomer rubber), with a Shore hardness of 10 to 45 degrees.
  • the soft joint of this embodiment The material of 1 is silica gel with a Shore hardness of 45 degrees.
  • the vent tube 2 is made of a medical elastomer polymer material, such as silicone rubber, or TPE (thermoplastic elastomer), or TPU (polyurethane elastomer rubber), with a Shore hardness of 50 to 80 degrees.
  • the vent tube 2 of this embodiment is made of silica gel and has a Shore hardness of 60 degrees.
  • the adjustable positioning ring 3 is made of hard medical polymer material, such as hard silicone rubber, or PC (polycarbonate), or PVC (polyvinyl chloride), the material of this embodiment is hard silicone rubber .
  • the fixing member 6 and the monitoring catheter 7 are made of medical polymer materials, such as silicone rubber, or PVC (polyvinyl chloride), or TPU (polyurethane elastomer rubber).
  • the fixing member 6 and the monitoring device of this embodiment The material of the conduit 7 is PVC (polyvinyl chloride).
  • the male connector 8 is made of a rigid medical polymer material, such as PC (polycarbonate), or PP (polypropylene), or PVC (polyvinyl chloride).
  • PC polycarbonate
  • PP polypropylene
  • PVC polyvinyl chloride
  • the filter 9 is connected to the male connector 8 in a locking manner.
  • the oxygen supply process monitors the patient's breathing frequency, O 2 concentration and CO 2 concentration at any time through the monitoring catheter 7, pay attention to observe the sputum secretion in the patient's airway, and promptly suck sputum according to the correct method; If emergency ventilation is needed to rescue the patient, remove the rotary joint 5 and the monitoring catheter 7, connect the air source joint 4 to the breathing equipment, and perform mechanical ventilation; after the operation, release the fixation and remove the nasopharyngeal ventilation tube 2.

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Abstract

一种软头可调的鼻咽通气管，由软接头(1)、通气管(2)、可调定位环(3)、气源接头(4)、旋转接头(5)、固定件(6)、监视导管(7)、公接头(8)和过滤器(9)组成，结构中气源接头(4)可直接连接呼吸设备进行紧急通气；旋转接头(5)既可以灵活转动方向，又可以同时实现输氧、吸痰功能；软接头(1)顶部圆滑过渡和材质硬度相比较通气管(2)材质硬度偏低，能够有效保护鼻腔粘膜不受损伤；可调定位环(3)调节固定通气管(2)的位置，有效控制插入深度；监视导管(7)能监测病人的呼吸频率、O 2浓度及CO 2浓度，增强安全性；过滤器(9)能有效过滤患者呼出气体中的水分，同时保证CO 2气体的顺利通过。结构中组件的材质，均不采用金属材质。

Description

[根据细则91更正 19.01.2020]　一种软头可调鼻咽通气管 技术领域
[根据细则91更正 19.01.2020]　
本发明属于医疗器械技术领域，具体涉及一种软头可调鼻咽通气管，是作为人工气道通气应用于紧急救助和辅助呼吸或手术麻醉的一种医疗器械。
背景技术
鼻咽通气管是经鼻腔插入咽腔的一种人工气道，它的作用是解除或缓解患者上呼吸道通气不畅或梗阻。鼻咽通气管一般由软硅胶或塑料材料制成，为顺应人体鼻咽腔的生理结构，其结构形状设计为呈弧形的管状，软硬度适中，长度与人体鼻腔到口咽腔的距离相当。鼻咽通气管端口为斜口，插入时可减少与鼻腔组织的摩擦，利于通过鼻腔。
鼻咽通气管因在临床上的应用价值，受到医务工作者和医疗器械行业的极大关注，但是普通鼻咽通气管结构和功能简单。近些年来，为满足医疗水平不断发展的要求，对鼻咽通气管的结构改进日益增加，有关鼻咽通气管的结构由如下专利文献报道：
1、中国发明专利，专利号为CN201320727635.2(授权公告日20140507)公开了一种带监视导管的鼻咽通气管，由接头，衬套，通气管，固定件，监视导管和公接头组成。该发明的优点：1)独立的监视导管可随时监测病人的呼吸频率、O 2浓度及CO 2浓度，增加鼻粘膜湿度，增强安全性。2)固定件用于固定监视导管，使其不易滑落，避免过深插人病人鼻腔，造成损伤。3)具有可旋转的多功能接头，可对患者同时进行输氧、吸痰等操作，安全高效。
2、中国发明专利，专利号为CN201520053161.7(授权公告日20150930)公开了一种鼻咽通气管道，包括管体、管接头和三通接头，管体内壁附有钢丝圈，管体的两边内侧有可供吸痰用的管道，所述管道连至所述管体出口的位置。 该发明的鼻咽通气管道除能够保证鼻咽道通畅以外，亦能够有效进行气道护理，监测二氧化碳浓度，使治疗或监测过程更加便捷，安全，有效；能够在呼吸困难病人的早期阶段进行干预，亦能够适用于非气管插管麻醉下的胸外科手术。
3、中国发明专利，专利号为CN201710813360.7(申请公布日20171212)公开了一种鼻咽吸氧管，包括单鼻孔吸氧管，单鼻孔吸氧管的一端通过病人鼻孔插入至其鼻咽处，另一端通过连接头连接至氧源，单鼻孔吸氧管上靠近其插入端部设置有固定件，固定件用于当插入端部插入到病人鼻咽处时，将单鼻孔吸氧管固定在病人鼻孔处，以防止插入端部滑动。本发明通过将单鼻孔吸氧管的插入端部插入到病人鼻咽处，大大地提高了病人吸入氧气的浓度，更有利于病人的康复，且通过在单鼻孔吸氧管的插入端部侧面设置有温度传感器，可以实时监测病人的鼻咽温度，已达到检测病人体温的效果，减轻了病人的痛苦，加快了病人的康复过程。
4、中国发明专利，专利号为CN109939320A(申请公布日20190628)
本发明实施例公开了一种鼻咽通气管道，其包括充气囊、给药囊和主体管，所述主体管依照鼻咽气道自然弧度成型且为弧形，并具有用于探入至口咽部的近端和位于鼻前庭外部的远端；所述主体管中具有从远端延伸到近端的通气腔，从而分别形成远端通气开口和远端通气开口，所述充气囊设置于所述近端并具有柱形空间，所述充气囊的内腔与所述充气管腔的远端充气阀连通，其中所述近端通气开口背对于所述通气腔近端处的轴线向着管体腹侧翘起，以形成近端通气开口导向端翘起部。本发明的鼻咽通气管道具有结构简单、操作方便以及成本低廉的特点，易于推广使用。
但是，上述4种鼻咽通气管存在如下缺陷:(1)供氧功能和机械通气功能只能实现其中的一种，无法做到兼容。(2)不能实现呼末CO 2的过滤。无法保证 CO 2浓度监视的准确度。(3)管体材质硬度为整段式，不能很好的满足患者需求；材质较软，易造成插管困难和通气不足，材质较硬，易造成鼻腔粘膜的损伤出血。4)通气管头部斜角部位为尖头设计，插管易造成鼻腔粘膜的损伤出血。5)通气管插入深度不能有效控制，易造成患者不适或通气不足。(6)部分专利产品包含金属材质，不支持术中通过核磁共振检查。
如何设计对患者同时进行输氧、吸痰等操作，安全高效，结构简单、操作方便以及成本低廉和易于推广使用的鼻咽通气管，以克服现有技术存在的缺陷，成为医务工作者和医疗器械行业的极大关注，为医疗器械行业界工程技术人员亟待开发和研究的课题。
发明内容
[根据细则91更正 19.01.2020]　
本发明的目的在于提供一种软头可调鼻咽通气管，其结构由软接头，通气管，可调定位环，气源接头，旋转接头，固定件，监视导管，公接头和过滤器组成，该结构中具有可灵活旋转的接头，可以同时实现输氧、吸痰和监视功能，气源接头可直接连接呼吸设备进行紧急通气，过滤器可有效过滤患者呼出气体中的水分，同时保证CO 2气体的顺利通过，软接头设计成顶部圆滑过渡，其材质硬度相比较通气管材质硬度偏低能够有效保护鼻腔粘膜不受损伤，可调定位环调节固定通气管的位置，有效控制插入深度，所需配件均不采用金属材质，从而解决了上述现有技术存在的问题。
本发明为实现上述目的，所采用的技术方案是：
一种软头可调鼻咽通气管，包括通气管，直径为2.0mm～8.0mm，长度为20.0cm～50.0cm的监视导管，结构设计为两个环状套口连接为一体的固定件和通过粘接或紧配的方式与监视导管连接为一体的公接头，其特征在于：所述软头可调鼻咽通气管，其结构由软接头，通气管，可调定位环，气源接头，旋 转接头，固定件，监视导管，公接头和过滤器组成，其中：
软接头，其结构设计为一端以粘接或紧配或焊接的方式与通气管头部连接，另一端设计为顶部圆滑过渡带斜口结构的分段式结构，或与通气管形成一体的顶部圆滑过渡带斜口结构的一体式结构，
通气管，其管体结构形状呈弧状或直型，管内径为2.0mm～10.0mm,长度为8cm～25cm，
可调定位环，结构设计为环状套口状，其设置在通气管外壁上，优选的通过滑配方式与通气管相连接，使其可在通气管外壁上滑动，进而实现可调定位功能，
气源接头，其一端以粘接或紧配的方式与通气管尾部连接，另一端以紧配或锁紧的方式与旋转接头和监视导管连接，
旋转接头，其结构形状设计为以一定夹角形式连接的两个中空的柱状体，一个连接输氧管，一个连接气源接头，所述夹角大小为90°～180°，其以紧配的方式与气源接头相连并可实现不同角度的旋转，其与气源接头之间的连接方式，优选的设计为相互分离式，保证紧急通气功能与供氧功能、监测病人的呼吸频率、O 2浓度及CO 2浓度功能切换自如，
固定件，其结构设计为分体式的两个环状套口固定件，其一端以粘接或紧配的方式与监视导管连接，另一端以粘接或紧配的方式与旋转接头连接，其两个环状套口的内径均与监视导管的外径相同，
监视导管,其管径为2.0mm～8.0mm，长度为20.0cm～50.0cm，其贯穿于旋转接头和通气管之中，其中旋转接头通过固定件与监视导管连接，所述监视导管远端处设有一公接头，公接头通过粘接或紧配的方式与监视导管连接为一体，
公接头，其设置在监视导管远端处，并通过粘接或紧配的方式与监视导管 连接为一体，
过滤器，通过锁紧的方式与公接头相连。
所述软接头，其材质为医用弹性体高分子材料，诸如硅橡胶，或TPE(热塑性弹性体)，或TPU(聚氨酯弹性体橡胶)，邵氏硬度10度～45度。
所述的通气管，其材质为医用弹性体高分子材料，诸如硅橡胶，或TPE(热塑性弹性体)，或TPU(聚氨酯弹性体橡胶)，邵氏硬度50度～80度。
所述的可调定位环，材质为硬质医用高分子材料，诸如硬质硅橡胶，或PC(聚碳酸酯)，或PVC(聚氯乙烯)。
所述的固定件和监视导管，其材质均为医用高分子材料，诸如硅橡胶，或PVC(聚氯乙烯)，或TPU(聚氨酯弹性体橡胶)。
所述的公接头，其材质为硬质医用高分子材料，诸如PC(聚碳酸酯)，或PP(聚丙烯)，或PVC(聚氯乙烯)。
与现有技术相比，本发明的有益效果是：
1)本发明中的气源接头可直接连接呼吸设备进行机械通气，实现病人的紧急救助；安装监视导管后即可实现供氧功能和监测病人的呼吸频率、O 2浓度及CO 2浓度，增强安全性；同时避免了再次插管，减轻了患者痛苦，减少了医务人员手术前后的工作量，有利于提高医护人员的工作效率。
2)过滤器具备优异的疏水性能，既能有效过滤患者呼出气体中的水分，又保证CO 2气体的顺利通过，有利于提高监测数值的准确度。
3)软接头头部柔软并且圆弧过渡而管体部分保持较高的硬度，有利于通气管顺利进入，同时避免插管时损伤患者鼻腔粘膜。
4)可调定位环能够调节固定通气管的位置，有效控制插入深度，避免通气不足以及造成患者的不适。
5)产品中不含金属材质，支持术中通过核磁共振检查，方便医生及时查验患者病情状况，无需重复插管，减轻患者痛苦。
附图说明
图1为本发明软头可调鼻咽通气管的结构示意图；
图1中：1软接头；2通气管；3可调定位环；4气源接头；5旋转接头；6固定件；7监视导管；8公接头；9过滤器。
具体实施方式
为了使本技术领域的人员更好地理解本发明技术方案，下面结合附图和实施方式对本发明作进一步的详细说明。
实施例
一种软头可调鼻咽通气管，所述软头可调鼻咽通气管，其结构由软接头1，通气管2，可调定位环3，气源接头4，旋转接头5，固定件6，监视导管7，公接头8和过滤器9组成，其中：
软接头1，其结构设计为一端以粘接或紧配或焊接的方式与通气管2头部连接，另一端设计为顶部圆滑过渡带斜口结构的分段式结构，或与通气管2形成一体的顶部圆滑过渡带斜口结构的一体式结构，本实施例软接头1的结构设计为一端以粘接方式与通气管2头部连接，另一端设计为顶部圆滑过渡带斜口结构的分段式结构；
通气管2,其管体结构形状呈弧状或直型，管内径为2.0mm～10.0mm,长度为8cm～25cm，本实施例形状为弧形，管内径为8mm,长度为18cm，
可调定位环3，结构设计为环状套口状，其设置在通气管2外壁上，优选的通过滑配方式与通气管2相连接，使其可在通气管2外壁上滑动，进而实现可调定位功能，
气源接头4，其一端以粘接或紧配的方式与通气管2尾部连接，另一端以紧配或锁紧的方式与旋转接头5和监视导管7连接，本实施例的气源接头4，其一端以紧配的方式与通气管2尾部相连，另一端以紧配的方式与旋转接头5和监视导管7连接，
旋转接头5，其结构形状设计为以一定夹角形式连接的两个中空的柱状体，一个连接输氧管，一个连接气源接头4，所述夹角大小为90°～180°，本实施夹角大小设计为90°,其以紧配的方式与气源接头4相连并可实现不同角度的旋转，其与气源接头4之间的连接方式，优选的设计为相互分离式，保证紧急通气功能与供氧功能、监测病人的呼吸频率、O 2浓度及CO 2浓度功能切换自如，
固定件6，其结构设计为分体式的两个环状套口固定件，其两个环状套口的内径均与监视导管7的外径相同，其一端以粘接或紧配的方式与监视导管7连接，另一端以粘接或紧配的方式与旋转接头5，本实施例的固定件6，其一端以粘接的方式与监视导管7连接，另一端以粘接的方式与旋转接头5连接，
监视导管7,其管径为2.0mm～8.0mm，长度为20.0cm～50.0cm，本实施例的监视导管7的直径和长度，分别设计为2.5mm和30.0cm，其贯穿于旋转接头5和通气管2之中，其中旋转接头5通过固定件6与监视导管7连接，所述监视导管7远端处设有一公接头8，公接头8通过粘接或紧配的方式与监视导管7连接为一体，本实施例的公接头8通过粘接方式与监视导管7连接为一体，
公接头8，其设置在监视导管7远端处，并通过粘接或紧配的方式与监视导管7连接为一体，本实施例的公接头8通过粘接方式与监视导管7连接为一体，
过滤器9，其通过锁紧的方式与公接头8相连。
所述软接头1，其材质为医用弹性体高分子材料，诸如硅橡胶，或TPE(热塑性弹性体)，或TPU(聚氨酯弹性体橡胶)，邵氏硬度10度～45度，本实施例 软接头1的材质为硅胶，邵氏硬度45度。
所述的通气管2，其材质为医用弹性体高分子材料，诸如硅橡胶，或TPE(热塑性弹性体)，或TPU(聚氨酯弹性体橡胶)，邵氏硬度50度～80度。本实施例的通气管2，材质为硅胶，邵氏硬度60度。
所述的可调定位环3，材质为硬质医用高分子材料，诸如硬质硅橡胶，或PC(聚碳酸酯)，或PVC(聚氯乙烯)，本实施例的材质为硬质硅橡胶。
所述的固定件6和监视导管7，其材质均为医用高分子材料，诸如硅橡胶，或PVC(聚氯乙烯)，或TPU(聚氨酯弹性体橡胶)，本实施例的固定件6和监视导管7的材质均为PVC(聚氯乙烯)。
所述的公接头8，其材质为硬质医用高分子材料，诸如PC(聚碳酸酯)，或PP(聚丙烯)，或PVC(聚氯乙烯)。本实施例公接头8的材质为PC(聚碳酸酯)
所述过滤器9，通过锁紧的方式与公接头8连接。
使用方法：
采用正确临床医学技术进行软头可调的鼻咽通气管插管操作，具体如下：将旋转接头5与吸氧管连接，调整旋转接头5至适宜的方向，固定鼻咽通气管，将过滤器9与呼吸检测设备相连，开始使用时，供氧过程通过监视导管7随时监测病人的呼吸频率、O 2浓度及CO 2浓度，注意观察患者气道内痰液分泌情况，按正确方法及时吸痰；如需对病人实施紧急通气救助，拔除旋转接头5和监视导管7，将气源接头4与呼吸设备连接，进行机械通气；手术后，解除固定，拔除鼻咽通气管2。
以上描述了本发明的基本原理、主要特征和本发明的优点，本行业的技术人员应该了解，本发明不受上述实施例的限制，上述实施例和说明书中描述的仅为本发明的优选例，并不用来限制本发明，在不脱离本发明精神和范围的前 提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。

Claims (6)

  1. 一种软头可调鼻咽通气管，包括通气管，直径为2.0mm～8.0mm，长度为20.0cm～50.0cm的监视导管，结构设计为两个环状套口连接为一体的固定件和通过粘接或紧配的方式与监视导管连接为一体的公接头，其特征在于：所述软头可调鼻咽通气管，其结构由软接头(1)，通气管(2)，可调定位环(3)，气源接头(4)，旋转接头(5)，固定件(6)，监视导管(7)，公接头(8)和过滤器(9)组成，其中：
    软接头(1)，其结构设计为一端以粘接或紧配或焊接的方式与通气管(2)头部连接，另一端设计为顶部圆滑过渡带斜口结构的分段式结构，或与通气管(2)形成一体的顶部圆滑过渡带斜口结构的一体式结构，
    通气管(2)，其管体结构形状呈弧状或直型，管内径为2.0mm～10.0mm,长度为8cm～25cm，
    可调定位环(3)，结构设计为环状套口状，其设置在通气管(2)外壁上，优选的通过滑配方式与通气管(2)相连接，使其可在通气管(2)外壁上滑动，进而实现可调定位功能，
    气源接头(4)，其一端以粘接或紧配的方式与通气管(2)尾部连接，另一端以紧配或锁紧的方式与旋转接头(5)和监视导管(7)连接，
    旋转接头(5)，其结构形状设计为以一定夹角形式连接的两个中空的柱状体，一个连接输氧管，一个连接气源接头(4)，所述夹角大小为90°～180°，其以紧配的方式与气源接头(4)相连并可实现不同角度的旋转，其与气源接头(4)之间的连接方式，优选的设计为相互分离式，保证紧急通气功能与供氧功能、监测病人的呼吸频率、O 2浓度及CO 2浓度功能切换自如，
    固定件(6)，其结构设计为分体式的两个环状套口，其一端以粘接或紧配的方式与监视导管(7)连接，另一端以粘接或紧配的方式与旋转接头(5)连 接，
    监视导管(7),其管径为2.0mm～8.0mm，长度为20.0cm～50.0cm，其贯穿于旋转接头(5)和通气管(2)之中，其中旋转接头(5)通过固定件(6)与监视导管(7)连接，所述监视导管(7)远端处设有一公接头(8)，公接头(8)通过粘接或紧配的方式与监视导管(7)连接为一体，
    公接头(8)，其设置在监视导管(7)远端处，并通过粘接或紧配的方式与监视导管(7)连接为一体，
    过滤器(9)，通过锁紧的方式与公接头(8)相连。
  2. 根据权利要求1所述一种软头可调鼻咽通气管，其特征在于：所述软接头(1)，其材质为医用弹性体高分子材料，诸如硅橡胶，或TPE(热塑性弹性体)，或TPU(聚氨酯弹性体橡胶)，邵氏硬度10度～45度。
  3. 根据权利要求1所述一种软头可调鼻咽通气管，其特征在于：所述的通气管(2)，其材质为医用弹性体高分子材料，诸如硅橡胶，或TPE(热塑性弹性体)，或TPU(聚氨酯弹性体橡胶)，邵氏硬度50度～80度。
  4. 根据权利要求1所述一种软头可调鼻咽通气管，其特征在于：所述的可调定位环(3)，材质为硬质医用高分子材料，诸如硬质硅橡胶，或PC(聚碳酸酯)，或PVC(聚氯乙烯)。
  5. 根据权利要求1所述一种软头可调鼻咽通气管，其特征在于：所述的固定件(6)和监视导管(7)，其材质均为医用高分子材料，诸如硅橡胶，或PVC(聚氯乙烯)，或TPU(聚氨酯弹性体橡胶)。
  6. 根据权利要求1所述一种软头可调鼻咽通气管，其特征在于：所述的公接头(8)，其材质为硬质医用高分子材料，诸如PC(聚碳酸酯)，或PP(聚丙烯)，或PVC(聚氯乙烯)。
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CN203577094U (zh) * 2013-11-14 2014-05-07 邹德伟 带有监视导管的鼻咽通气管
CN204033973U (zh) * 2014-08-15 2014-12-24 中国人民解放军南京军区南京总医院 一次性防脱落可供氧的鼻咽通气导管
CN105343974A (zh) * 2015-12-15 2016-02-24 邹德伟 与co2浓度监测装置相配套用的呼吸麻醉医疗器械组件
WO2016115158A1 (en) * 2015-01-16 2016-07-21 City Of Hope Airway device with multiple channels
CN107349502A (zh) * 2017-08-21 2017-11-17 天津美迪斯医疗用品有限公司 一种带气源接头的口咽通气道
CN107456640A (zh) * 2017-09-11 2017-12-12 西安市第医院 一种鼻咽吸氧管
CN110496285A (zh) * 2019-08-02 2019-11-26 天津美迪斯医疗用品有限公司 一种软头可调鼻咽通气管

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN203577094U (zh) * 2013-11-14 2014-05-07 邹德伟 带有监视导管的鼻咽通气管
CN204033973U (zh) * 2014-08-15 2014-12-24 中国人民解放军南京军区南京总医院 一次性防脱落可供氧的鼻咽通气导管
WO2016115158A1 (en) * 2015-01-16 2016-07-21 City Of Hope Airway device with multiple channels
CN105343974A (zh) * 2015-12-15 2016-02-24 邹德伟 与co2浓度监测装置相配套用的呼吸麻醉医疗器械组件
CN107349502A (zh) * 2017-08-21 2017-11-17 天津美迪斯医疗用品有限公司 一种带气源接头的口咽通气道
CN107456640A (zh) * 2017-09-11 2017-12-12 西安市第医院 一种鼻咽吸氧管
CN110496285A (zh) * 2019-08-02 2019-11-26 天津美迪斯医疗用品有限公司 一种软头可调鼻咽通气管

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