WO2020147328A1 - 气管导管固定用的负压吸附式牙垫 - Google Patents
气管导管固定用的负压吸附式牙垫 Download PDFInfo
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- WO2020147328A1 WO2020147328A1 PCT/CN2019/106582 CN2019106582W WO2020147328A1 WO 2020147328 A1 WO2020147328 A1 WO 2020147328A1 CN 2019106582 W CN2019106582 W CN 2019106582W WO 2020147328 A1 WO2020147328 A1 WO 2020147328A1
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- dental pad
- tracheal tube
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- gap
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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
Definitions
- the present invention relates to the technical field of medical instruments, in particular to a negative pressure adsorption dental pad used for tracheal tube fixation.
- Tracheal intubation refers to the technique of inserting a special tracheal tube into the trachea through the glottis called tracheal intubation. This technique can provide the best conditions for airway patency, ventilation and oxygen supply, airway suction and prevention of aspiration.
- the traditional method of fixing the endotracheal tube has always been to fix the dental pad and the endotracheal tube with adhesive tape, and then directly use the adhesive tape to paste on both cheeks of the patient.
- This method has many disadvantages: 1.
- the tape is easily affected by the sweat glands and oily secretions of the skin, which makes the tape and the skin not stick firmly, and there is still a lot of mobility after the tracheal tube is fixed, especially when the patient is agitated or changes position , It is more likely to cause catheter displacement, de-tubation and other phenomena, which endanger the patient’s life safety; 2.
- Oral secretions, sputum, etc. are easily retained, forming a bacterial culture medium, causing the patient to be at risk of infection; 4. Tongue activities The catheter will be disturbed. After the catheter is disturbed, the clamping part will loosen, causing the tracheal tube to loosen; 5.
- the occlusal part is made of hard materials, which avoids the problem of bite, but it is easy to affect the patient’s teeth, gums, and oral cavity. The mucous membranes cause damage and need to be improved.
- Oral secretions and sputum are easily retained and form bacterial culture media, which may cause the patient to be at risk of infection; 4.
- the movement of the tongue will disturb the catheter. After the catheter is disturbed, the clamping part will loosen, causing the tracheal tube to loosen; 5.
- the occlusal part is made of hard materials, which avoids the problem of bite, but it is easy to affect the patient’s teeth and gums. , The oral mucosa causes damage and needs to be improved.
- the invention uses a unique negative pressure adsorption dental pad to solve the above problems. Its fixing method is stable and reliable, occupies a small volume of the oral cavity, and has high patient comfort. At the same time, it is not easy to damage the patient's teeth, gums and oral mucosa, and is easy to clean oral secretions. Widely used clinically.
- the tooth pad (1) is designed with a groove (14) that can be fitted to the tracheal tube.
- the groove (14) is made of non-toxic elastic materials such as TPE, silicone, etc., and there is an exhaust channel (113) on the groove , The size of the groove matches the corresponding type of tracheal tube.
- the gap (116) between the tubes (2) is obviously reduced, and the inside is negative pressure, so that the tracheal tube is adsorbed on the tooth pad.
- a syringe can be used to pump air through the exhaust channel (113) to further increase the internal negative pressure of the gap between the dental pad and the tracheal tube, so that the tracheal tube can be more firmly adsorbed on the dental pad.
- the contact surface between the groove of the tooth pad (1) and the tracheal tube (2) is tightly fitted and fully enclosed, with a gap (115) (116) in the middle, and the exhaust channel (113) of the tooth pad has a one-way valve (114) ), in order to better close the gap after exhausting the gas, prevent air intake, and maintain the gap negative pressure.
- Dental pad (1) According to the shape of the tracheal tube after intubation in the oral cavity, the lower half is arc-shaped to better absorb the tracheal tube on the dental pad.
- the lower half of the tooth pad (1) gradually becomes thinner, which reduces the volume of the tooth pad in the oral cavity, improves the comfort of the patient, and at the same time facilitates the tooth pad to better absorb the tracheal tube.
- tie hole (121) which can be used to tie the dental pad and the tracheal tube together to further improve the firmness and increase the safety. Then it can be tied directly to the neck of the patient with a lace for effective fixation.
- the middle of the tooth pad is made of hard non-toxic materials such as PC (111) which is anti-bite, and the outer periphery of the tooth pad is made of flexible non-toxic materials (112) such as TPE and silica gel.
- the composite is hard inside and soft outside. The inner hard and outer soft design not only prevents the bite tube from causing bite closure, but also protects the oral mucosa, teeth and gums.
- the baffle (12) of the dental pad is placed outside the patient's mouth and against the patient's lips or the outer surface of the teeth, so as to prevent the tracheal tube from sliding into the deep airway and causing unilateral lung ventilation.
- the unique negative pressure adsorption design makes the tooth pad directly adsorb a piece of tracheal tube, which feels like there is only one tracheal tube.
- the oral cavity is small in size, which not only relieves the patient’s pain, but also facilitates the cleaning of oral secretions. Only one person is required to perform oral care, which saves manpower; the oral cavity is small in size while outsourcing soft materials, which is good for patients’ teeth and gums. , The oral mucosa has a protective effect.
- the device can be quickly and reliably fixed in pre-hospital first aid, hospital treatment, and emergency medical rescue events for critically ill patients after oral tracheal intubation; the device has a simple and reasonable structure, low cost, easy to carry and use, reliable fixation and powerful functions. The characteristics provide a reliable way for the fixation of critically ill patients after oral tracheal intubation.
- Figure 1 is a schematic diagram of the tooth pad structure
- Figure 2 is a schematic diagram of the cross section of the tooth pad and tracheal tube parallel to the baffle before adsorption;
- Figure 3 is a schematic diagram of the structure of the cross-section of the tooth pad and tracheal tube parallel to the baffle after adsorption;
- Fig. 4 is a schematic view of the structure of the dental pad of Fig. 1 perpendicular to the central axis of the baffle before adsorption, in which the tracheal tube only shows the part in contact with the dental pad;
- Figure 5 is a schematic diagram of the structure of the two left and right tooth pads and the tracheal tube parallel to the baffle after adsorption;
- Dental pad 11. The upper part of the dental pad, 111. The hard material in the middle of the dental pad, 112. The soft material to prevent damage to the outer periphery of the dental pad, 113 The exhaust channel of the dental pad, 114. Teeth One-way valve of the cushion exhaust channel, 115. The gap between the dental cushion and the tracheal tube before adsorption, 116. The gap between the dental cushion and the tracheal tube after adsorption, 12 the baffle of the dental cushion, 121. The hole of the dental cushion, 13. The lower part of the tooth pad includes the bite and extension, 14. The groove of the tooth pad.
- the tooth pad When using it, pay attention to the different types of tracheal tubes should be put into the corresponding model of the tooth pad, and the tooth pad has a left side adsorption and right side adsorption distinction.
- the tooth pad and the corresponding type of tracheal tube are put together or packaged for convenient use.
- the groove of the tooth pad is moistened with water before use to better fit the tracheal tube (in emergency, it will not affect the use of this step).
- the present invention is not limited to the specific embodiments described above, but extends to various modifications within the scope of the appended claims.
- the original design of the tooth pad did not have a one-way exhaust channel.
- the one-way exhaust channel of the tooth pad can be placed on the side of the tooth pad instead of on the top.
- the tooth pad of the invention has simple structure, low manufacturing process requirements, low cost, and easy mass production.
- the tooth pad of the present invention adopts a unique negative pressure adsorption type, has a stable and reliable fixing method, small oral cavity volume, high patient comfort, and is not easy to damage the patient's teeth, gums, and oral mucosa, and is easy to clean oral secretions, and is suitable for clinical use The wide range of applications. Therefore, the dental pad of the present invention has high industrial applicability.
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Abstract
一种负压吸附式牙垫，包括挡板（2）和凹槽（14），牙垫按气管导管在口腔中的走形设计成下半部为弧形。凹槽（14）上有单向排气孔（113），凹槽（14）和气管导管（2）间有较大的空隙（115），用力挤压气体排出后，空隙（115）明显减小，其内部呈负压，从而把气管导管（2）吸附在牙垫上，然后用注射器通过单向排气孔（113）抽气增加牙垫和气管导管（2）间空隙（115）的内部负压。通过负压吸附式设计，负压越大，固定越牢固，而且负压可使气管导管（2）通气的腔道轻度变大，使牙垫直接和气管导管（2）吸附一块，占用口腔部体积小，不仅能减轻患者的痛苦，方便进行口腔护理，而且只需要一人就可以进行，节约人力。
Description
本发明涉及医用器械的技术领域，特别是涉及一种用于气管导管固定的负压吸附式牙垫。
在临床上对危重病人、全麻患者，需要进行气管插管来帮助病人呼吸。气管插管是指将一特制的气管导管经声门置入气管的技术称为气管插管，这一技术能为气道通畅、通气供氧、呼吸道吸引和防止误吸等提供最佳条件。
传统的气管导管固定方法一直是沿用先将牙垫和气管导管用胶布固定后，再直接用胶布粘贴到患者两侧面颊上。这种方法有很多缺陷：1.胶布易受皮肤的汗腺及油性分泌物的影响，使胶布与皮肤粘贴不牢，气管导管固定后仍有很大活动度，特别是当病人躁动或变换体位时，更容易发生导管移位、脱管等现象而危及病人的生命安全；2.还可出现皮肤牵拉过紧现象，易使病人产生不适感，甚至刺激皮肤引发炎症或表皮溃烂，导致继发感染发；3. 口腔分泌物容易被滞留在胶布上面，形成细菌培养基，造成病员有感染的危险；4. 操作复杂，常需两人配合才能完成。
近年来出现了各种类型的专用的气管导管固定器，专门放置在患者口中，即可用来插入气管，也可用来插入吸痰管。但是大部分设计复杂，价格贵，成本高，边角、缝隙多，口腔分泌物、痰液等容易滞留，形成细菌培养基，造成病员有感染的危险。
而且不管是传统的牙垫胶布固定法还是专用的气管导管固定器，大部分都存在以下缺陷：1. 为了更好的固定气管导管，防止脱管，需要较大的压力，但是压力越大越容易挤扁气管导管，造成气管导管通气的腔道变小；2. 口腔被胶布或者气管导管固定器封住，牙垫或者气管导管固定装置偏大，占用口腔部体积过大，患者舒适度低，而且不方便清理口腔内分泌物，进行口腔护理时需要两人配合才能进行，浪费人力；3. 口腔分泌物、痰液等容易滞留，形成细菌培养基，造成病员有感染的危险；4.舌头活动会扰动导管，导管被扰动后会造成夹持处松脱，导致气管导管松掉；5. 咬合部分采用硬质材料制作，这样虽然避免了咬闭的问题，但是容易对病人牙齿、牙龈、口腔粘膜造成伤害，有待改进。
不管是传统的牙垫胶布固定法还是专用的气管导管固定器，大部分都存在以下缺陷：1. 为了更好的固定气管导管，防止脱管，需要较大的压力固定气管导管，但是压力越大越容易挤扁气管导管，造成气管导管通气的腔道变小；2.牙垫或者气管导管固定装置偏大，占用口腔部体积过大，口腔被胶布或者气管导管固定器封住，患者舒适度低，而且不方便清理口腔内分泌物，进行口腔护理时需要两人配合才能进行，浪费人力；3. 口腔分泌物、痰液等容易滞留，形成细菌培养基，造成病员有感染的危险；4.舌头活动会扰动导管，导管被扰动后会造成夹持处松脱，导致气管导管松掉；5. 咬合部分采用硬质材料制作，这样虽然避免了咬闭的问题，但是容易对病人牙齿、牙龈、口腔粘膜造成伤害，有待改进。
本发明采用独特的负压吸附式牙垫解决上述问题，其固定方式稳定可靠，占用口腔体积小，患者舒适度高，同时不易损伤病人牙齿、牙龈、口腔粘膜，而且便于清理口腔内分泌物，适合临床上的广泛应用。
1.牙垫（1）设计一个可贴合于气管导管的凹槽（14），凹槽（14）为具有弹性的TPE 、硅胶等无毒弹性材料，凹槽上有排气通道（113），凹槽大小和相对应型号气管导管相匹配。牙垫（1）的凹槽和气管导管（2）间有较大的空隙（115），用力挤压后气体通过排气通道和牙垫周边排出，使牙垫（1）的凹槽和气管导管（2）间的空隙（116）明显减小，其内部呈负压，从而把气管导管吸附在牙垫上。然后可以用注射器通过排气通道（113）抽气进一步增加牙垫和气管导管空隙的内部负压，从而把气管导管更牢固吸附在牙垫上。
2.牙垫（1）的凹槽和气管导管（2）接触面外周为紧密贴合全封闭，中间有空隙（115）（116），牙垫排气通道（113）有单向阀门（114），以利于排出气体后更好的封闭空隙，防止进气，保持空隙负压。
3.牙垫（1）按照插管后的气管导管在口腔中的走形设计，下半部为弧形，以更好的把气管导管吸附在牙垫上。牙垫（1）下半段逐步变薄，减少牙垫在口腔内的体积，提高病人的舒适度，同时有利于牙垫更好的吸附于气管导管。
4. 系孔（121）上有系带，可以用系带将牙垫和气管导管系在一起，以进一步提高牢固性，增加安全性。然后可以用系带直接系在患者颈项部，起到有效的固定作用。
5.牙垫中间为防咬闭的PC 等硬质无毒材料（111），牙垫外周为具有弹性的TPE 、硅胶等软质无毒材料（112），复合后的呈内硬外软。内硬外软设计即防咬管引起咬闭的问题，又对口腔粘膜、牙齿、牙龈有保护作用。
6. 牙垫的挡板（12）置于患者口腔外且抵住患者的嘴唇或者牙齿外表面，从而能够防止气管导管滑入气道深处引起单侧肺通气。
1.独特的负压吸附式设计，吸附的负压越大，固定越牢固，负压吸附可使气管导管通气的腔道轻度变大，所以可以使用更大的负压吸附使得固定更加牢固。而一般气管导管固定器或者牙垫胶布固定法为了更好的固定气管导管，防止脱管，需要较大的正压力，但是压力越大固定越牢固的同时也越容易挤扁气管导管，造成气管导管通气的腔道变小。
2. 独特的负压吸附式设计，结合用系带将牙垫和气管导管系在一起，使气管导管和牙垫固定的一侧为负压吸附，另一侧为正压固定，这样更加牢固。必要时可用左右2个牙垫同时固定气管导管，这样会更加牢固，但同时有增加牙垫口腔部体积的副作用。特殊情况下如患者明显躁动不安，必要时可加用胶布粘贴以提高安全性，将负压吸附法和和传统的牙垫胶布固定法结合在一起将会使气管导管固定较传统方法更加牢固。
3. 独特的负压吸附式设计，使牙垫直接和气管导管吸附一块，感觉就像只有一根气管导管。占用口腔部体积小，不仅能减轻患者的痛苦，而且方便清理口腔内分泌物，进行口腔护理时只需要一人就可以进行，节约人力；占用口腔部体积小同时外包软质材料，对病人牙齿、牙龈、口腔粘膜具有保护作用。
4. 系孔上有系带，可以用系带直接系在患者头部或者颈项部，起到有效的固定作用。避免了传统的胶布固定易松动、过敏现象等缺点，同时也减轻了病人的痛苦，减少了医务人员的繁琐操作；同时口腔呈开放状态，有利于吸痰、清除口腔分泌物等护理工作，不用撕开胶布或者移开气管导管固定器等复杂步骤，一个人就可以操作。
该装置可在院前急救、院内救治、突发紧急医疗救援事件中危重患者经口气管插管后快速进行可靠固定；该装置结构简单合理、成本低、携带使用方便、固定牢靠和功能强大的特点，为危重患者经口气管插管后的固定提供了可靠的途径。
图1 为牙垫结构示意图；
图2 为牙垫和气管导管平行于挡板的横切面在吸附前结构示意图；
图3 为牙垫和气管导管平行于挡板的横切面在吸附后结构示意图；
图4 为图1 的牙垫垂直于挡板的中轴纵切面在吸附前结构示意图，其中气管导管仅显示和牙垫接触的部分；
图5 为左右2个牙垫和气管导管平行于挡板的横切面在吸附后结构示意图；
图中1. 牙垫、11.牙垫的上部、 111. 牙垫中间防咬闭的硬质材料、 112. 牙垫外周防损伤的软质材料、 113 牙垫的排气通道、 114. 牙垫排气通道的单向阀门、 115.牙垫和气管导管在吸附前的空隙、 116.牙垫和气管导管在吸附后的空隙、 12牙垫的挡板、 121. 牙垫的系孔、 13. 牙垫的下部包括牙咬部和延伸部分、 14. 牙垫的凹槽。
使用时，注意根据不同型号气管导管应放入相应型号的牙垫，而且牙垫有左侧吸附和右侧吸附区分。一般将牙垫和相应型号气管导管放一起或者打包以方便使用。
1.牙垫凹槽使用前水湿润以更好的贴合气管导管（紧急情况下没这一步一般也不影响使用）。
2.在气管导管插入后，将牙垫放入病人口中，调整好位置，用力一压气体通过排气通道和牙垫周边排出，其内部呈负压，从而把气管导管吸附在牙垫上。
3.用系带将牙垫和气管导管系在一起，以提高牢固性，增加安全性。然后可以用系带直接系在患者头部或者颈项部，起到有效的固定作用，一般情况下不再需胶布粘贴，特殊情况下如患者明显躁动不安可加用胶布粘贴以提高安全性。将负压吸附法和传统的牙垫胶布固定法结合在一起将会使气管导管固定较传统方法更加牢固。
4.用注射器通过单向排气通道抽气使牙垫内部负压进一步增加，从而把气管导管更牢固吸附在牙垫上。
5.特殊情况下，如患者明显躁动不安，咬管明显，必要时可放置左右2个牙垫固定气管导管，这样会更加牢固，但同时有增加口腔部体积的副作用。
6.如果需要取下牙垫，可以用类似打篮球用的气针插入单向排气通道使气体进入，负压消失就可以，必要时可以用注射器通过气针注入气体，使牙垫和气管导管空隙由负压变成正压。也可以用注射器通过牙垫凹槽软质材料插进气管导管和牙垫空隙注入气体，但要注意用注射器法如果继续使用原先的牙垫可能导致牙垫密封性降低。
本发明不限定于上述特定的实施方案，而是扩展至所附的权利要求书的范围内的多种改型。实际上原本设计牙垫是没有单向排气通道的。模型试用中发现挤压牙垫和气管导管，气体通过牙垫周边漏出也是可以的，而且牙垫结构更加的简单，进一步降低牙垫的成本，但是内部负压相对较低，降低牢固性。又比如牙垫单向排气通道可以放在牙垫侧边而不是上边也可以的。本领域的技术人员应当理解，可以对本发明的技术方案进行修改或者等同替换，而不脱离本发明技术方案的精神和范围，其均应涵盖在本发明的权利要求范围当中。
本发明的牙垫结构简单，制作工艺要求低，成本低，易于大批量生产。本发明的牙垫采用独特的负压吸附式，具有固定方式稳定可靠，占用口腔体积小，患者舒适度高，同时不易损伤病人牙齿、牙龈、口腔粘膜，而且便于清理口腔内分泌物，适合临床上的广泛应用。所以本发明的牙垫具有很高的工业实用性。
Claims (8)
- 一种负压吸附式牙垫，其特征是：牙垫有一个凹槽， 凹槽和气管导管贴合后接触面有空隙，排出空隙气体后空隙减小，其内部呈负压，从而把气管导管和牙垫吸附在一起。
- 根据权利要求1 所述的牙垫，其特征是：牙垫凹槽为具有弹性的TPE 、硅胶等无毒弹性材料，凹槽大小和相对应型号气管导管相匹配；牙垫的凹槽和气管导管接触面外周为紧密贴合全封闭，中间有空隙。
- 根据权利要求1 所述的牙垫，其特征是：牙垫的凹槽有排气通道，排气通道有单向阀门，以利于排出气体并在排出气体后更好的封闭空隙，防止进气，保持空隙负压。
- 根据权利要求1 所述的牙垫，其特征是：牙垫按照插管后的气管导管在口腔中的走形设计，下半部为弧形，以更好的把气管导管吸附在牙垫上。
- 根据权利要求1 所述的牙垫，其特征是：牙垫下半段逐步变薄，减少牙垫在口腔内的体积，提高病人的舒适度，同时有利于牙垫更好的吸附于气管导管。
- 根据权利要求1 所述的牙垫，其特征是：牙垫上有系孔，系孔上有系带，用于将气管导管固定在牙垫上然后系在患者头部或者颈项部，起到有效的固定作用。
- 根据权利要求1 所述的牙垫，其特征是：牙垫有挡板防止气管导管滑脱。
- 根据权利要求1 所述的牙垫，其特征是：牙垫中间为防咬闭的PC 等硬质无毒材料，外周具有弹性的TPE 、硅胶等软质无毒材料，复合后的呈内硬外软。
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