JP2014133041A - Intratracheal intubation tube-mounting device, and manufacturing method thereof - Google Patents
Intratracheal intubation tube-mounting device, and manufacturing method thereof Download PDFInfo
- Publication number
- JP2014133041A JP2014133041A JP2013003749A JP2013003749A JP2014133041A JP 2014133041 A JP2014133041 A JP 2014133041A JP 2013003749 A JP2013003749 A JP 2013003749A JP 2013003749 A JP2013003749 A JP 2013003749A JP 2014133041 A JP2014133041 A JP 2014133041A
- Authority
- JP
- Japan
- Prior art keywords
- tube
- intubation tube
- endotracheal intubation
- flow sensor
- sensor mounting
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 238000002627 tracheal intubation Methods 0.000 title claims abstract description 149
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 17
- 239000012530 fluid Substances 0.000 claims abstract description 17
- 230000002093 peripheral effect Effects 0.000 claims abstract description 16
- 239000002184 metal Substances 0.000 claims description 29
- 238000000034 method Methods 0.000 claims description 14
- 238000001514 detection method Methods 0.000 claims description 4
- 239000010408 film Substances 0.000 description 26
- 239000000758 substrate Substances 0.000 description 19
- 210000003437 trachea Anatomy 0.000 description 18
- 230000029058 respiratory gaseous exchange Effects 0.000 description 11
- 230000002269 spontaneous effect Effects 0.000 description 9
- 241000283973 Oryctolagus cuniculus Species 0.000 description 8
- 239000004809 Teflon Substances 0.000 description 8
- 229920006362 Teflon® Polymers 0.000 description 8
- 229920002379 silicone rubber Polymers 0.000 description 8
- 239000004945 silicone rubber Substances 0.000 description 8
- 229920005989 resin Polymers 0.000 description 6
- 239000011347 resin Substances 0.000 description 6
- 238000009423 ventilation Methods 0.000 description 6
- 230000008569 process Effects 0.000 description 5
- 230000000241 respiratory effect Effects 0.000 description 5
- 210000003238 esophagus Anatomy 0.000 description 4
- 238000009434 installation Methods 0.000 description 4
- 210000000056 organ Anatomy 0.000 description 4
- 239000007788 liquid Substances 0.000 description 3
- 229920002050 silicone resin Polymers 0.000 description 3
- 238000010171 animal model Methods 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 238000012790 confirmation Methods 0.000 description 2
- 238000005520 cutting process Methods 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- 239000010409 thin film Substances 0.000 description 2
- 208000003443 Unconsciousness Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 238000011088 calibration curve Methods 0.000 description 1
- 238000002680 cardiopulmonary resuscitation Methods 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000009429 electrical wiring Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 238000002695 general anesthesia Methods 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000011259 mixed solution Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Landscapes
- Measuring Volume Flow (AREA)
Abstract
【課題】気管内挿管チューブ内を流れる流体の流量を正確に計測することが可能な気管内挿管チューブ用装着装置及び製造方法を提供する。
【解決手段】コネクタ３は、一方側で人工呼吸器接続用チューブ３０と連結し、他方側で挿管チューブ２を着脱可能に取り付ける。コネクタ３の凹部３ｄ内には、位置決め固定部材５を介して、管状型流量センサ装着部４が装着されている。挿管チューブ２の内径「ａ」とほぼ同一の内径「ｂ」を有する管状型流量センサ装着部４を成形する際、挿管チューブ２の流路を規定する内周部と流量センサ装着部４の内周部をほぼ同一にする。位置決め固定部材５は挿管チューブ２内の流路と管状型流量センサ装着部４内の流路が連続的に大きな段差なく連通するよう流量センサ装着部４を位置決め固定する。
【選択図】図２An attachment device for an endotracheal intubation tube and a manufacturing method capable of accurately measuring the flow rate of a fluid flowing in the endotracheal intubation tube are provided.
A connector 3 is connected to a ventilator connecting tube 30 on one side, and an intubation tube 2 is detachably attached on the other side. A tubular flow sensor mounting portion 4 is mounted in the recess 3 d of the connector 3 via a positioning fixing member 5. When forming a tubular flow sensor mounting portion 4 having an inner diameter “b” that is substantially the same as the inner diameter “a” of the intubation tube 2, the inner peripheral portion that defines the flow path of the intubation tube 2 and the flow sensor mounting portion 4 Make the circumference almost the same. The positioning fixing member 5 positions and fixes the flow sensor mounting part 4 so that the flow path in the intubation tube 2 and the flow path in the tubular flow sensor mounting part 4 are continuously communicated with each other without a large step.
[Selection] Figure 2
Description
本発明は、気管内挿管チューブ内を流れる呼気吸気の流量を正確に検出することができる気管内挿管チューブ装着装置及びその製造方法に関する。 The present invention relates to an endotracheal intubation tube mounting device capable of accurately detecting the flow rate of exhaled breath flowing through an endotracheal intubation tube and a method for manufacturing the same.
高度な換気障害の際の人工呼吸管理、心肺蘇生及び全身麻酔時の呼吸管理、緊急時の呼吸管理を目的として、気管内挿管が施される。例えば、高度な換気障害では、気管内にチューブを挿入して気道を確保し、これを人工呼吸器に繋ぐ。本人工呼吸器では、一定の圧や容量により吸気を能動的に行なわせ、患者の呼吸器の弾性により受動的に呼気を行う。現在、医療現場では、上記目的で、気道内にチューブが挿入されるが、本手法には食道挿管と言われる重大な課題がある。以下に課題を説明する。 Endotracheal intubation is performed for the purpose of artificial respiration management at the time of advanced ventilation disorder, respiration management during cardiopulmonary resuscitation and general anesthesia, and emergency respiratory management. For example, in severe ventilation disorders, a tube is inserted into the trachea to secure the airway and connect it to a ventilator. In this ventilator, inspiration is actively performed with a certain pressure and volume, and passive expiration is performed with the elasticity of the patient's respiratory organ. Currently, in the medical field, a tube is inserted into the airway for the above purpose, but this method has a serious problem called esophageal intubation. The problem will be described below.
経口もしくは経鼻的に気管内チューブを挿入する場合、解剖学的構造により、チューブは気管ではなく、食道に挿入されやすい。従って、チューブ挿入時には、チューブが気管に挿入されるように細心の注意を払う必要がある。もし、誤って食道に挿入し、それに気づかない場合には、致命的な医療事故を引き起こすことになる。 When an endotracheal tube is inserted orally or nasally, the tube is likely to be inserted into the esophagus rather than the trachea due to the anatomy. Therefore, when inserting the tube, it is necessary to pay close attention so that the tube is inserted into the trachea. If it is accidentally inserted into the esophagus and you do not notice it, it can cause a fatal medical accident.
また、気管内にチューブを挿入した場合でも、患者が首の向きなどを変えたりすると、挿管チューブ先端部は、最大で５ｃｍ程度移動すると言われている。意識のはっきりしない患者自身による自己抜去や気管に挿管されているチューブが、気管から抜け、食道に挿入されることがある。上記の食道挿管と同様に、チューブの位置の異常に気づかないと、換気不全の状態が続くことになり、死に至ることもある。 Even when the tube is inserted into the trachea, if the patient changes the direction of the neck or the like, the distal end of the intubation tube is said to move about 5 cm at the maximum. Self-extraction by unconscious patients themselves or tubes that have been intubated into the trachea can escape from the trachea and be inserted into the esophagus. As with the above esophageal intubation, failure to notice any abnormal tube position will continue to result in insufficiency of ventilation, leading to death.
以上のことから、気管内挿管チューブは、挿入時及び使用時において、チューブが正しく気管に挿入されていることを確認する必要があるが、現在では、この確認は挿入時に非常に原始的な方法で行われており、機械的（工学的）な手法による安全支援は行われていない。 Based on the above, it is necessary to confirm that the endotracheal intubation tube is correctly inserted into the trachea at the time of insertion and use, but now this confirmation is a very primitive method at the time of insertion. Safety support is not provided by mechanical (engineering) methods.
一方、有効な自発呼吸が回復した際には、人工呼吸器を取り外すことになるが、臨床現場では、自発呼吸がどの程度、回復しているかをモニタリングすることが難しく、気管内挿管チューブの抜去は経験により行われ、再挿管が必要な場合もある。 On the other hand, when effective spontaneous breathing recovers, the ventilator will be removed. However, in clinical practice, it is difficult to monitor how much spontaneous breathing has recovered, and the endotracheal tube is removed. Is done by experience and may require re-intubation.
患者に人工呼吸をする際の患者の換気状態を把握するため、吸気を送り出す吸気チューブと呼気を送り出す呼気チューブとを有する人工呼吸回路にガスセンサーと温度センサーを設け、呼吸作用をモニター可能にする人工呼吸装置が提案されている（特許文献１参照）。また、生体の気管内に挿入された気管内チューブ内を流通する気体の流速を検出し、検出された流速の変化に基づいて生体の自発呼吸の発生を判定する補助人工呼吸器が提案されている（特許文献２参照）。更に、気管内挿管チューブ内にガスセンサなどの各種センサを設置する呼吸感知及び換気供給装置が提案されている（特許文献３参照）。 In order to grasp the ventilation state of the patient when ventilating the patient, a gas sensor and a temperature sensor are provided in an artificial respiration circuit having an inhalation tube that sends out inspiration and an exhalation tube that sends out exhalation so that the respiratory action can be monitored An artificial respiration apparatus has been proposed (see Patent Document 1). There has also been proposed an auxiliary ventilator that detects the flow rate of gas flowing through the endotracheal tube inserted into the trachea of the living body and determines the occurrence of spontaneous breathing of the living body based on the change in the detected flow rate. (See Patent Document 2). Furthermore, a respiratory sensing and ventilation supply device in which various sensors such as a gas sensor are installed in an endotracheal intubation tube has been proposed (see Patent Document 3).
ところで、本願発明者は、チューブ内を流れる流体の流量を計測する手段として、フレキシブル基材にヒータを形成し、このフレキシブル基材を管内壁形状に沿うように管内壁に実装するような構造の流量センサを開発している。この流量センサは、厚さ数ミクロンのフィルム上にセンサを作製し、これを流速が最も小さくなる配管の内壁面に実装しているため、センサ設置に伴う流体抵抗の増加を極限まで低減できるという特徴がある（例えば、特許文献４参照）。また、上記流量センサを熱収縮チューブにより小型化する技術も開発している（例えば、特許文献５参照）。また、本願発明者は、生体の管状器官に埋め込んで管状器官内の媒体の流量を計測することを目的とした生体埋め込み型流量センサを開発している。この流量センサでは、管状器官内を流れる媒体の流量が同じであれば、流れの向きに寄らず、センサの出力が同一になるセンサ構造を提案している（例えば、特許文献６参照）。 By the way, the inventor of the present application has a structure in which a heater is formed on a flexible base as a means for measuring the flow rate of the fluid flowing in the tube, and the flexible base is mounted on the inner wall of the pipe along the inner wall of the pipe. A flow sensor is being developed. This flow sensor is manufactured on a film with a thickness of several microns and is mounted on the inner wall surface of the pipe where the flow velocity is the smallest, so the increase in fluid resistance associated with sensor installation can be reduced to the utmost limit. There are features (see, for example, Patent Document 4). Moreover, the technique which miniaturizes the said flow sensor with a heat contraction tube is also developed (for example, refer patent document 5). The inventor of the present application has also developed a biological implantable flow sensor that is embedded in a tubular organ of a living body and aims to measure the flow rate of a medium in the tubular organ. In this flow sensor, a sensor structure is proposed in which the output of the sensor is the same regardless of the flow direction if the flow rate of the medium flowing in the tubular organ is the same (see, for example, Patent Document 6).
しかしながら、いずれの上記特許文献において「一方側で人工呼吸器接続用チューブと連結し、他方側で気管内挿管チューブを連結するコネクタ内部に、気管内挿管チューブ内の流路と同一サイズの流路からなる管状型流量センサを設置するもの」は開示されていない。また、挿管時及び使用時において気管内挿管チューブが食道ではなく、正しく気管に挿入されていることを簡単に判断できるものでもない。既述したごとく、気管内挿管及び使用時において、チューブが正しく気管に挿入されていることを正確に且つ容易に確認できれば医療スタッフの負荷が軽減できるので、医の安全を確保し患者の管理や治療を支援できる装置開発が所望されている。 However, in any of the above-mentioned patent documents, “the flow channel of the same size as the flow channel in the endotracheal intubation tube is provided inside the connector that is coupled to the ventilator connection tube on one side and the endotracheal intubation tube on the other side. "Installing a tubular flow sensor consisting of" is not disclosed. Also, it is not easy to determine that the endotracheal intubation tube is not the esophagus and is correctly inserted into the trachea during intubation and use. As already mentioned, during endotracheal intubation and use, the burden on medical staff can be reduced if the correct and easy confirmation that the tube is correctly inserted into the trachea. Development of a device capable of supporting treatment is desired.
本発明は、上記課題を解決するものであり、気管内挿管チューブを気管に挿入するときに、気管内挿管チューブが生体の気管に挿入されていることを正確に確認できる、また自発換気量が容易に確認できる、気管内挿管チューブ用装着装置及びその製造方法を提供することを目的とする。 The present invention solves the above problems, and when inserting an endotracheal intubation tube into the trachea, it is possible to accurately confirm that the endotracheal intubation tube is inserted into the trachea of a living body, and the spontaneous ventilation is It is an object of the present invention to provide an endotracheal intubation tube mounting device and a method for manufacturing the same that can be easily confirmed.
上記目的を達成するためになされた請求項１に記載の発明は、一方側で人工呼吸器接続用チューブと連結することができ、他方側で気管内挿管チューブを着脱可能に取り付ける気管内挿管チューブ用装着装置の製造方法である。その製造方法において、種々のサイズの流路を有する気管内挿管チューブの流路を規定する内周部と連結できる、ほぼ同一の流路に規定する内周部を有する管状型流量センサ装着部を成形する。その後、前記気管内挿管チューブ内の流路と前記管状型流量センサ装着部内の流路が連続的に大きな段差なく連通するよう、前記管状型流量センサ装着部を前記人工呼吸器接続用チューブ及び気管内挿管チューブ間に位置決め固定部材を用いて位置決め固定する。 In order to achieve the above object, the invention according to claim 1, wherein the endotracheal intubation tube can be connected to the ventilator connection tube on one side and the endotracheal intubation tube is detachably attached to the other side. It is a manufacturing method of the mounting apparatus for a vehicle. In the manufacturing method, a tubular flow sensor mounting portion having an inner peripheral portion that is defined in substantially the same flow path and that can be connected to an inner peripheral portion that defines the flow path of an endotracheal intubation tube having various size flow paths. Mold. Thereafter, the tubular flow sensor mounting portion is connected to the ventilator connecting tube and the air flow tube so that the flow path in the endotracheal intubation tube and the flow channel in the tubular flow sensor mounting portion are continuously communicated without a large step. Positioning and fixing is performed using a positioning fixing member between the intubation tubes.
請求項１の発明によれば、人工呼吸器用チューブと気管内挿管チューブとの間に配置される気管内挿管チューブ用装着装置内に管状型流量センサ装着部を設け、気管内挿管チューブ内を通る気体（呼気吸気）の流量を測定する構造にする。気管内挿管チューブの流路を規定する内周部と流量センサ装着部の内周部をほぼ同一にし、更に、気管内挿管チューブ内の流路と管状型流量センサ装着部内の流路が連続的に大きな段差なく連通するよう、管状型流量センサ装着部を人工呼吸器接続用チューブ及び気管内挿管チューブ間に位置決め固定部材を用いて位置決め固定する結果、管内流れでの乱れを極限まで低減でき、管内を流れる流量を正確に測定できる。
請求項２に記載の発明によれば、請求項１に記載の気管内挿管チューブ用装着装置の製造方法において、位置合わせ用型及び外縁用枠型を用いて位置決め固定部材を成形し、その位置決め固定部材を用いて、前記気管内挿管チューブ内の流路と前記管状型流量センサ装着部内の流路の位置合わせを行うことを特徴とする。
According to the first aspect of the present invention, the tubular flow sensor mounting portion is provided in the endotracheal intubation tube mounting device disposed between the ventilator tube and the endotracheal intubation tube, and passes through the endotracheal intubation tube. Structure to measure the flow rate of gas (exhaled breath). The inner circumference defining the flow path of the endotracheal intubation tube and the inner circumference of the flow sensor mounting part are substantially the same, and the flow path in the endotracheal intubation tube and the flow path in the tubular flow sensor mounting part are continuous. As a result of positioning and fixing the tubular flow sensor mounting part between the ventilator connection tube and the endotracheal intubation tube using a positioning fixing member so as to communicate with each other without a large step, the disturbance in the flow in the tube can be reduced to the limit, The flow rate flowing through the pipe can be measured accurately.
According to the second aspect of the present invention, in the manufacturing method of the endotracheal intubation tube mounting device according to the first aspect, the positioning and fixing member is formed using the alignment mold and the outer edge frame mold, and the positioning is performed. A fixing member is used to align the flow path in the endotracheal intubation tube and the flow path in the tubular flow sensor mounting portion.
位置合わせ用型及び外縁用枠型を用いて位置決め固定部材を成形する場合、位置決め固定部材は高い精度で成形されることになる。
請求項３に記載の発明によれば、一方側で人工呼吸器接続用チューブと連結することができ、他方側で気管内挿管チューブを着脱可能に取り付ける気管内挿管チューブ用装着装置である。その装着装置は、種々のサイズの流路を有する気管内挿管チューブの流路を規定する内周部と連結できる、ほぼ同一の流路に規定する内周部を有するように成形された管状型流量センサ装着部と、前記気管内挿管チューブ内の流路と前記管状型流量センサ装着部内の流路が連続的に大きな段差なく連通するよう、前記管状型流量センサ装着部を前記人工呼吸器接続用チューブ及び気管内挿管チューブ間に配置させる位置決め固定部材とを備えることを特徴とする。
When the positioning fixing member is molded using the alignment mold and the outer edge frame mold, the positioning fixing member is molded with high accuracy.
According to invention of Claim 3, it is a mounting apparatus for endotracheal intubation tubes which can be connected with the ventilator connection tube on one side and detachably attach the endotracheal intubation tube on the other side. The mounting device is a tubular mold formed to have an inner peripheral portion that defines a substantially identical flow path that can be connected to an inner peripheral portion that defines a flow path of an endotracheal intubation tube having various sizes of flow paths. Connect the tubular flow sensor mounting part to the ventilator so that the flow path in the endotracheal intubation tube and the flow path in the tubular flow sensor mounting part are continuously communicated without a large step. And a positioning and fixing member disposed between the tube and the endotracheal intubation tube.
請求項４記載の発明によれば、前記気管内挿管チューブ用装着装置内に前記管状型流量センサ装着部を挿管するための凹部を気管内挿管チューブ用装着位置と反対位置に設け、当該凹部内に前記位置決め固定部材を用いて管状型流量センサ装着部を装着したことを特徴とする。 According to invention of Claim 4, the recessed part for intubating the said tubular type flow sensor attachment part in the said attachment apparatus for endotracheal intubation tubes is provided in the position opposite to the attachment position for endotracheal intubation tubes, A tubular flow sensor mounting portion is mounted using the positioning fixing member.
装着装置の気管内挿管チューブ用装着位置と反対位置に管状型流量センサ装着部を装着するので、管状型流量センサ装着部が誤って体内に入ることがない。
請求項５記載の発明によれば、前記管状型流量センサ装着部に用いられる熱線流速計用金属ヒータはフィルム上に作製され、かつ、当該フィルムが管状チューブの内壁面に沿うように実装されていることを特徴とする。
Since the tubular flow sensor mounting portion is mounted at a position opposite to the mounting position for the endotracheal intubation tube of the mounting device, the tubular flow sensor mounting portion does not accidentally enter the body.
According to the fifth aspect of the present invention, the metal heater for a hot-wire velocimeter used in the tubular flow sensor mounting portion is manufactured on a film, and the film is mounted so as to be along the inner wall surface of the tubular tube. It is characterized by being.
熱線流速計用金属ヒータが作製されたフィルムが管状チューブの内壁面に沿うように実装されている場合、管状型流量センサ装着部内の流体流れに影響を与えにくい構造となり、管内を流れる流量を正確に測定できる。 When the film on which the metal heater for the hot-wire velocimeter is fabricated is mounted along the inner wall surface of the tubular tube, it has a structure that hardly affects the fluid flow in the tubular flow sensor mounting part, and the flow rate flowing through the tube is accurate. Can be measured.
請求項６記載の発明によれば、前記管状型流量センサ装着部の流量検出部が金属ヒータからなり、且つ、熱的に絶縁された構造になっており、前記金属ヒータから前記気内挿管チューブ内を流れる流体への熱伝達量で、前記気管内挿管チューブ内を流れる流体流量を検出することを特徴とする。
流量検出部として熱線流速計の金属ヒータが熱的に絶縁された構造になっているので、気管内挿管チューブ内を流れる流体流量を正確に検出することができる。
According to invention of Claim 6, the flow volume detection part of the said tubular type flow sensor mounting part consists of a metal heater, and has a thermally insulated structure, The said endotracheal intubation tube from the said metal heater The flow rate of the fluid flowing in the endotracheal intubation tube is detected by the amount of heat transfer to the fluid flowing in the inside.
Since the metal heater of the hot-wire anemometer is thermally insulated as the flow rate detector, the flow rate of the fluid flowing through the endotracheal intubation tube can be accurately detected.
図１３に示すコネクタの場合、挿管チューブ接続側と反対の人工呼吸器接続側と比較すると、気体の流れる管の内径が人工呼吸器接続側で大径になっているため、コネクタ内側に一般的な管状型流量センサを仮に設置することを想定した場合、コネクタ内での流れが「拡大管流れ」となり、気管内挿管チューブ内の流れを高精度に計測することができないという問題が生じる可能性がある。 In the case of the connector shown in FIG. 13, compared to the ventilator connection side opposite to the intubation tube connection side, the inner diameter of the tube through which the gas flows is larger on the ventilator connection side. Assuming that a tubular flow sensor is installed, the flow in the connector becomes an “expanded tube flow”, and there is a possibility that the flow in the endotracheal intubation tube cannot be measured with high accuracy. There is.
それに対し、請求項１及び３に記載の発明では、気管内挿管チューブの流路を規定する内周部と流量センサ装着部の内周部をほぼ同一にし、更に、気管内挿管チューブ内の流路と管状型流量センサ装着部内の流路が連続的に大きな段差なく連通するよう、管状型流量センサ装着部を人工呼吸器接続用チューブ及び気管内挿管チューブ間に位置決め固定部材を用いて固定するので、気管内挿管チューブ及び管状型流量センサ装着部内の流れの乱れを極限まで低減できる。その結果、気管内挿管チューブ内を流れる流量を正確に測定できる。 On the other hand, in the inventions according to claims 1 and 3, the inner peripheral part defining the flow path of the endotracheal intubation tube and the inner peripheral part of the flow sensor mounting part are made substantially the same, and further, the flow in the endotracheal intubation tube is further reduced. Fix the tubular flow sensor mounting part between the ventilator connection tube and the endotracheal intubation tube using a positioning fixing member so that the channel and the flow path in the tubular flow sensor mounting part are continuously communicated with each other without a large step. Therefore, the disturbance of the flow in the endotracheal intubation tube and the tubular flow sensor mounting portion can be reduced to the limit. As a result, the flow rate flowing through the endotracheal intubation tube can be accurately measured.
以上の構成により、挿管チューブ内を流れる流体の流量を常に正確に計測することが可能となり、その結果、以下に示す医療システムが可能となる。
（１）気管内挿管チューブ用装着装置の挿管チューブ部分を気道に挿入する際、挿管チューブ内を流れる気体の流量をリアルタイムで計測することが可能となり、挿管チューブが正しく気管に挿入されているか否かを判断することが容易になる。
With the above configuration, the flow rate of the fluid flowing in the intubation tube can always be accurately measured, and as a result, the medical system shown below is possible.
(1) When the intubation tube portion of the endotracheal intubation tube mounting device is inserted into the airway, the flow rate of the gas flowing through the intubation tube can be measured in real time, and whether the intubation tube is correctly inserted into the trachea. It becomes easy to judge.
（２）自発呼吸が改善され、気管内挿管チューブ及びそれに繋がれた人工呼吸器を患者から外す場合、先ず、人工呼吸器を外し、この状態で気管内挿管チューブ用装着装置にて流量計測すれば、患者の自発呼吸量を定量的に把握できる。すなわち、本プロセスを用いることで、患者の十分な自発呼吸量を定量的に確認した後、気管内挿管チューブを患者から取り外すことができ、人工呼吸器を外す際の安全性を確保できる。 (2) When spontaneous breathing is improved and the endotracheal intubation tube and ventilator connected to it are removed from the patient, the ventilator is first removed, and in this state, the flow rate is measured by the endotracheal intubation tube mounting device. Thus, it is possible to quantitatively grasp the spontaneous breathing volume of the patient. That is, by using this process, after confirming the patient's sufficient spontaneous breathing amount quantitatively, the endotracheal intubation tube can be removed from the patient, and safety when removing the ventilator can be ensured.
以下、本発明を実施するための最良の形態をより詳細に説明する。
本発明を具体化した実施の形態を図１に示す。気管内挿管チューブ付き装着装置１（以下単に「装着装置」という）は、気管内挿管チューブ（以下単に「挿管チューブ」という）２を生体外において着脱可能なコネクタ３から構成されている。コネクタ３は、その内部に管状型流量センサ装着部（管状チューブの周囲に流量センサを装着した部材）４を備えている。
Hereinafter, the best mode for carrying out the present invention will be described in more detail.
An embodiment embodying the present invention is shown in FIG. An attachment device 1 with an endotracheal intubation tube (hereinafter simply referred to as “attachment device”) includes a connector 3 that can attach and detach an endotracheal intubation tube (hereinafter simply referred to as “intubation tube”) 2 in vitro. The connector 3 includes a tubular flow sensor mounting portion (a member having a flow sensor mounted around the tubular tube) 4 therein.
挿管チューブ２は、使用者の年齢及び性別に応じて、外径及び長さの異なった種類のものが製造されている。挿管チューブ２の外径は、４．３ｍｍから、０．３ｍｍ〜０．４ｍｍ刻みで１６．０ｍｍ程度まである。通常、挿管チューブ２は長めに作製されており、生体の気管内に挿入される患者の体格等を考慮し、適切な長さに切断して使用される。
挿管チューブ２及びコネクタ３等の断面構造を図２に示す。図２に示すコネクタ３は、気管に挿入される挿管チューブ２を一端側で接続し、他端側で人工呼吸器接続用チューブに接続するコネクタとしての機能を果たす。具体的には、コネクタ３は、取付口３ａ、鍔部３ｂ、大径部３ｃ、凹部３ｄを備えている。取付口３ａは挿管チューブ２を取り付けるためのものであり、挿管チューブ２の内径（図２「ａ」参照）に対応する外形を有するのであり、挿管チューブ２の上記寸法に対応したサイズになる。
The intubation tube 2 is manufactured with different types of outer diameters and lengths according to the age and sex of the user. The outer diameter of the intubation tube 2 is from 4.3 mm to about 16.0 mm in increments of 0.3 mm to 0.4 mm. Usually, the intubation tube 2 is made longer, and is cut into an appropriate length and used in consideration of the physique of a patient inserted into the trachea of a living body.
The cross-sectional structures of the intubation tube 2 and the connector 3 are shown in FIG. The connector 3 shown in FIG. 2 functions as a connector that connects the intubation tube 2 inserted into the trachea at one end side and connects to the ventilator connection tube at the other end side. Specifically, the connector 3 includes an attachment port 3a, a flange portion 3b, a large diameter portion 3c, and a concave portion 3d. The attachment port 3a is for attaching the intubation tube 2 and has an outer shape corresponding to the inner diameter of the intubation tube 2 (see “a” in FIG. 2), and has a size corresponding to the above dimensions of the intubation tube 2.
大径部３ｃは、挿管チューブ２の内径に比して大径であり、人工呼吸器側チューブの内径サイズに合わせてあり、人工呼吸器側チューブにそのまま連結することができる。なお、鍔部３ｂは取付口３ａと大径部３ｃとの間に位置し、通常、鍔部３ｂ及び大径部３ｃは患者の口外の位置にする。 The large-diameter portion 3c has a larger diameter than the inner diameter of the intubation tube 2, matches the inner diameter size of the ventilator-side tube, and can be directly connected to the ventilator-side tube. In addition, the collar part 3b is located between the attachment port 3a and the large diameter part 3c, and the collar part 3b and the large diameter part 3c are usually positioned outside the patient's mouth.
大径部３ｃの取付口３ａ（管内チューブ２用装着位置と反対位置）には、人工呼吸器接続用チューブ側に開いた凹部３ｄが設けられており、凹部３ｄに管状型流量センサ装着部４を装着することで、管状型流量センサ装着部４は挿管チューブ２内を流れる流体を検出することができる構造になっている。 The attachment port 3a of the large diameter portion 3c (a position opposite to the attachment position for the in-tube tube 2) is provided with a recess 3d opened on the ventilator connection tube side, and the tubular flow sensor attachment portion 4 is provided in the recess 3d. By mounting the tubular flow sensor mounting portion 4, the fluid flowing through the intubation tube 2 can be detected.
なお、挿管チューブ２を個々の患者に応じて長さを切断調整する際、挿管チューブ２の先端部は、気管への挿管が容易になるような形状で作製されているため、長さ調整は挿管チューブ２をコネクタ３の取付口３ａから一度外してチューブを切断することになるので、コネクタ３の大径部３ｃ側はチューブ挿入時に切断などの調整をする必要が無い。このような大径部３ｃの内部に管状型流量センサ装着部４を装着するので、管状型流量センサ装着部４が誤って体内に入る可能性がないという利点があり、また、大径部３ｃは剛性が高い構造になっているので、使用時に患者が動いても大径部３ｃ内の管状型流量センサ装着部４に外力が加わることを極力低減できる利点がある。 In addition, when cutting and adjusting the length of the intubation tube 2 according to an individual patient, the distal end portion of the intubation tube 2 is made in a shape that facilitates intubation into the trachea. Since the intubation tube 2 is once removed from the attachment port 3a of the connector 3 and the tube is cut, the large diameter portion 3c side of the connector 3 does not need adjustment such as cutting when the tube is inserted. Since the tubular flow sensor mounting portion 4 is mounted inside the large diameter portion 3c, there is an advantage that the tubular flow sensor mounting portion 4 may not enter the body by mistake, and the large diameter portion 3c. Since it has a structure with high rigidity, there is an advantage that external force can be reduced as much as possible to the tubular flow sensor mounting portion 4 in the large diameter portion 3c even if the patient moves during use.
ここで、管状型流量センサ装着部４の具体的な構造について説明すると、管状型流量センサ装着部４は、フィルム状基板１２に作製した熱線流速計用金属ヒータ１４をチューブ１５の管内壁面に実装したカテーテル（管状）構造になっている。この場合、チューブ１５は二層構造になっており、熱線流速計用金属ヒータ１４が形成されたフィルム基板１２が内側チューブの内壁面に内装される。また、フィルム基板１２の金属ヒータ１４が形成されている部分の外側部分は、内側チューブが存在せず、外側チューブのみが存在する構造になっている。これは、熱線流速計用金属ヒータ１４を熱絶縁するための空洞構造１６を形成するためである。なお、使用環境に応じて、熱線流速計用金属ヒータ１４の表面には、保護膜１７を形成することが望ましい。
内側チューブ内径（図２「ｂ」参照）は挿管チューブ２の内径（図２「ａ」）とほぼ一致しており、挿管チューブ２、取付口３ａ及び内側チューブ内の気体の流れは「拡大管流れ」にならなく、挿管チューブ２、取付口３ａ及び管状型流量センサ装着部４内の流路が連続的に大きな段差なく連通することになる。
Here, the specific structure of the tubular flow sensor mounting portion 4 will be described. The tubular flow sensor mounting portion 4 mounts the metal heater 14 for a hot-wire velocimeter made on the film substrate 12 on the inner wall surface of the tube 15. It has a catheter (tubular) structure. In this case, the tube 15 has a two-layer structure, and the film substrate 12 on which the metal heater 14 for a heat ray velocimeter is formed is provided on the inner wall surface of the inner tube. Further, the outer portion of the film substrate 12 where the metal heater 14 is formed has a structure in which only the outer tube exists without the inner tube. This is to form a cavity structure 16 for thermally insulating the metal heater 14 for a hot wire anemometer. In addition, it is desirable to form the protective film 17 on the surface of the metal heater 14 for hot-wire anemometers according to the use environment.
The inner diameter of the inner tube (see FIG. 2B) is substantially the same as the inner diameter of the intubation tube 2 (FIG. 2A), and the gas flow in the intubation tube 2, the attachment port 3a and the inner tube is “expanded tube”. The flow path in the intubation tube 2, the attachment port 3a, and the tubular flow sensor mounting part 4 is continuously communicated without a large step.
図１３に示すコネクタの場合、挿管チューブ接続側内径と人工呼吸器接続側内径と比べると、人工呼吸器接続側が大径になっているため、コネクタ内側に、管状型流量センサを設置することを考案する場合には、コネクタ内での流れが「拡大管流れ」となり、気管内挿管チューブ内の流れを高精度に計測することができない。 In the case of the connector shown in FIG. 13, since the ventilator connection side has a larger diameter than the intubation tube connection side inner diameter and the ventilator connection side inner diameter, it is necessary to install a tubular flow sensor inside the connector. In the case of devising, the flow in the connector becomes “expanded tube flow”, and the flow in the endotracheal intubation tube cannot be measured with high accuracy.
しかし、図２に示すコネクタ３の場合、その凹部３ｄの内側に位置決め固定部材５（後述）を介して管状型流量センサ装着部４を設置し、且つ、挿管チューブ２の内径「ａ」と管状型流量センサ装着部４の内径「ｂ」をほぼ同一にし、気管内挿管チューブ２の流路を規定する内周部と流量センサ装着部４の内周部をほぼ同一にする結果、連続的に大きな段差なく連通し、管内流れでの乱れを極限まで低減でき、管内を流れる流量を正確に測定できる。 However, in the case of the connector 3 shown in FIG. 2, the tubular flow sensor mounting portion 4 is installed inside the recess 3d via a positioning fixing member 5 (described later), and the inner diameter “a” of the intubation tube 2 and the tubular shape As a result of making the inner diameter “b” of the mold flow sensor mounting portion 4 substantially the same and making the inner peripheral portion defining the flow path of the endotracheal intubation tube 2 and the inner peripheral portion of the flow sensor mounting portion 4 substantially the same, It communicates without a large step, can reduce the turbulence in the pipe flow to the limit, and can accurately measure the flow rate in the pipe.
なお、管状型流量センサ装着部４をコネクタ３の挿管チューブ２の取付口３ａとは反対の人工呼吸器接続用チューブ３０側に設置し、コネクタ３の他端側は人工呼吸器接続用チューブ３０を介して人工呼吸器に繋がれるので、人工呼吸器から流れる気体が、人工呼吸器接続用チューブ３０を介して、管状型流量センサ装着部４、取付口３ａ及び挿管チューブ２内を通気状態（図２「呼気吸気」）になる。 The tubular flow sensor mounting portion 4 is installed on the side of the ventilator connection tube 30 opposite to the attachment port 3a of the intubation tube 2 of the connector 3, and the other end side of the connector 3 is the ventilator connection tube 30. Therefore, the gas flowing from the ventilator is ventilated through the ventilator connection tube 30 through the tubular flow sensor mounting portion 4, the attachment port 3 a and the intubation tube 2 ( FIG. 2 “exhaled inspiration”).
次に、管状型流量センサ装着部４に用いられる熱線流速計用金属ヒータ１４（流量検出部）をフィルム基板１２上に作製する作製方法を図３に示す。以下にその詳細を述べる。
図３（ａ）において、ガラス基板１０上に、シリコーンゴムシート１１を介して、フィルム基板１２を固定する。図３（ｂ）において、フィルム基板１２上に液体状の感光性樹脂１３を塗布し、その後、ホットプレートでプリベークする。図３（ｃ）において、紫外線で熱線流速計用金属パターンを感光性樹脂１３に露光し、ホットプレートにてポストベークを行う。その後、現像液で現像、流水洗浄を行い、フィルム基板１２上に感光性樹脂１３で熱線流速計用金属パターンを形成する。図３（ｄ）において、熱線流速計用金属パターンを形成した感光性樹脂１３上に金属薄膜１４を成膜する。
Next, FIG. 3 shows a production method for producing a metal heater 14 (flow rate detection unit) for a hot wire velocimeter used in the tubular flow rate sensor mounting portion 4 on the film substrate 12. Details are described below.
In FIG. 3A, a film substrate 12 is fixed on a glass substrate 10 via a silicone rubber sheet 11. In FIG.3 (b), the liquid photosensitive resin 13 is apply | coated on the film board | substrate 12, and it prebakes with a hotplate after that. In FIG.3 (c), the metal pattern for heat ray anemometers is exposed to the photosensitive resin 13 with an ultraviolet-ray, and it post-bakes with a hotplate. Thereafter, development with a developer and washing with running water are performed, and a metal pattern for a hot-wire anemometer is formed on the film substrate 12 with a photosensitive resin 13. In FIG.3 (d), the metal thin film 14 is formed on the photosensitive resin 13 in which the metal pattern for hot-wire anemometers was formed.
図３（ｅ）において、溶媒を用いて感光性樹脂１３を剥離し、フィルム基板１２上に金属薄膜製熱線流速計を作製する。最後に、フィルム基板１２をシリコーンゴムシート１１から剥がし、フィルム基板１２に熱線流速計用金属ヒータ１４を形成する。 In FIG. 3 (e), the photosensitive resin 13 is peeled off using a solvent, and a metal thin film hot-wire anemometer is produced on the film substrate 12. Finally, the film substrate 12 is peeled from the silicone rubber sheet 11, and a metal heater 14 for a hot wire velocimeter is formed on the film substrate 12.
図４は装着装置１に用いられる管状型流量センサ装着部４の写真である。上記フィルム基板１２に作製した熱線流速計用金属ヒータ１４をチューブの内壁面に沿うように実装して、管状型流量センサ装着部４を作製する。電気的な接続には異方性導電性フィルムを用い、フィルム基板１２上に形成した熱線流速計用金属ヒータ１４とエナメル線とを接続する。なお、接続には熱圧着を用いる。フィルム基板１２に形成した熱線流速計金属ヒータ１４のチューブ内実装には熱収縮チューブを用いる。チューブは、既述したごとく、二層構造になり、内側チューブの内壁面に熱線流速計用金属ヒータ１４が形成されたフィルム基板１２が実装され、フィルム基板１２の熱線流速計用金属ヒータ１４が形成されている部分の外側は、内側チューブが無く、外側チューブのみになっており、熱線流速計の金属ヒータ１４が熱的に絶縁された構造になっている。前記気管内挿管チューブ内を流れる流体流量を正確に検出することができる。 FIG. 4 is a photograph of the tubular flow sensor mounting portion 4 used in the mounting device 1. The metal heater 14 for a hot-wire anemometer produced on the film substrate 12 is mounted along the inner wall surface of the tube to produce the tubular flow sensor mounting portion 4. An anisotropic conductive film is used for electrical connection, and a metal heater 14 for a hot wire velocimeter formed on the film substrate 12 and an enameled wire are connected. Note that thermocompression bonding is used for connection. A heat-shrinkable tube is used for mounting the heat ray velocimeter metal heater 14 formed on the film substrate 12 in the tube. As described above, the tube has a two-layer structure, and the film substrate 12 on which the metal heater 14 for the heat ray velocimeter is formed is mounted on the inner wall surface of the inner tube, and the metal heater 14 for the heat ray velocimeter of the film substrate 12 is provided. The outside of the formed part has no inner tube but only the outer tube, and the metal heater 14 of the hot-wire anemometer is thermally insulated. The flow rate of fluid flowing through the endotracheal intubation tube can be accurately detected.
なお、管状型流量センサ装着部４の内径「ｂ」は、既述したごとく、挿管チューブ２の内径「ａ」と同一にするため、種々の内径サイズ及び管長のチューブを準備する。そして、管状型流量センサ装着部４の基材となる種々のチューブの内径サイズ及び管長に対応する熱線流速計用金属ヒータを形成するフィルムを予め準備して、そのフィルムを管状チューブの内壁面に沿うように実装させ、挿管チューブ２の内径「ａ」とほぼ同一の内径「ｂ」を有する管状型流量センサ装着部４を成形する。このように成形した場合、種々のサイズの流路を有する挿管チューブ２の流路を規定する内周部と連結できる、ほぼ同一の流路とする内周部を有する管状型流量センサ装着部４を成形することができる。 Note that, as described above, the inner diameter “b” of the tubular flow sensor mounting portion 4 is made the same as the inner diameter “a” of the intubation tube 2, so that tubes with various inner diameter sizes and tube lengths are prepared. And the film which forms the metal heater for hot-wire anemometers corresponding to the internal diameter size and tube length of the various tubes used as the base material of the tubular flow sensor mounting part 4 is prepared in advance, and the film is applied to the inner wall surface of the tubular tube. The tubular flow sensor mounting portion 4 having an inner diameter “b” substantially the same as the inner diameter “a” of the intubation tube 2 is formed. When formed in this way, a tubular flow sensor mounting portion 4 having an inner peripheral portion that has substantially the same flow path that can be connected to an inner peripheral portion that defines the flow path of the intubation tube 2 having flow paths of various sizes. Can be molded.
なお、挿管チューブ２の内径「ａ」と管状型流量センサ装着部４の内径「ｂ」は完全同一でなく、挿管チューブ２及び管状型流量センサ装着部４内の流体流れに影響を与えない程度の違い、例えばフィルム厚さ程度の違いがあってもよい。 It should be noted that the inner diameter “a” of the intubation tube 2 and the inner diameter “b” of the tubular flow sensor mounting portion 4 are not completely the same, and do not affect the fluid flow in the intubation tube 2 and the tubular flow sensor mounting portion 4. There may be a difference of, for example, a difference in film thickness.
次に、コネクタ３内に装着される位置決め固定部材５の作製方法を図５に示す。位置決め固定部材５の材料にはシリコーン樹脂を用いる。先ず、二液常温硬化性のシリコーン樹脂の主液と硬化剤を重量比で１０：１の割合で混合した。また、混合液中の気泡を取り除くため、真空ポンプを用いて脱泡を行った。以下に作製方法の詳細を述べる。 Next, a method for producing the positioning and fixing member 5 mounted in the connector 3 is shown in FIG. Silicone resin is used as the material for the positioning and fixing member 5. First, the main liquid of the two-component room temperature curable silicone resin and the curing agent were mixed at a weight ratio of 10: 1. Further, in order to remove bubbles in the mixed solution, defoaming was performed using a vacuum pump. Details of the manufacturing method will be described below.
図５（ａ）において、コネクタ３中央に位置合わせ型としてのテフロン製（登録商標）チューブ２０ａを配置する。挿管チューブ２の内径「ａ」が異なり、それによりコネクタ３の取付口３ａの内径が異なるため、必要に応じて異径チューブを用いてテフロン製のチューブ２０ａ（位置合わせ用型）をコネクタ３内中央に固定させる。次に、管状型流量センサ装着部４の外形と同一の外形を有するテフロン製のチューブ２０ｂをコネクタ３内に挿入する。このときテフロン製チューブ２０ａの外形とテフロン製チューブ２０ｂの内径とがほぼ同じになるようにし、チューブ２０ｂの内部にテフロン製チューブ２０ａが挿入されるようにする。 In FIG. 5A, a Teflon (registered trademark) tube 20a as an alignment mold is disposed in the center of the connector 3. Since the inner diameter “a” of the intubation tube 2 is different, and the inner diameter of the mounting port 3a of the connector 3 is thereby different, the Teflon tube 20a (positioning type) is inserted into the connector 3 using a different diameter tube as necessary. Fix in the center. Next, a Teflon tube 20 b having the same outer shape as that of the tubular flow sensor mounting portion 4 is inserted into the connector 3. At this time, the outer shape of the Teflon tube 20a and the inner diameter of the Teflon tube 20b are made substantially the same, and the Teflon tube 20a is inserted into the tube 20b.
図５（ｂ）において、コネクタ３の外周にシリコーンゴムシート２１をコネクタ３外縁から十分にはみ出るように巻き、シリコーンゴムシート２１を位置決め固定部材５の外縁用枠型とする。 In FIG. 5B, the silicone rubber sheet 21 is wound around the outer periphery of the connector 3 so as to sufficiently protrude from the outer edge of the connector 3, and the silicone rubber sheet 21 is used as an outer edge frame type of the positioning fixing member 5.
図５（ｃ）において、シリコーンゴムシート２１上面付近まで液状のシリコーン樹脂を流し込み、電気炉にて加熱硬化させる。その後シリコーンゴム製の位置決め固定部材５をコネクタ３から取り出し、チューブ２０ａおよび２０ｂ（位置合わせ用型）を引き抜き、位置決め固定部材５を完成させる。最後に、管状型流量センサ装着部４を位置決め固定部材５に容易に取り付け・取り外し易くなるように、位置決め固定部材５の長手方向にスリットを設ける。このように成形した位置決め固定部材５を用いて、挿管チューブ２内の流路と管状型流量センサ装着部４内の流路の位置合わせを行う場合、挿管チューブ２内の流路と管状型流量センサ装着部４内の流路が連続的に大きな段差なく連通する。 In FIG.5 (c), a liquid silicone resin is poured to the upper surface vicinity of the silicone rubber sheet 21, and it heat-hardens with an electric furnace. Thereafter, the positioning fixing member 5 made of silicone rubber is taken out from the connector 3, the tubes 20a and 20b (positioning molds) are pulled out, and the positioning fixing member 5 is completed. Finally, a slit is provided in the longitudinal direction of the positioning and fixing member 5 so that the tubular flow sensor mounting portion 4 can be easily attached to and detached from the positioning and fixing member 5. When positioning the flow path in the intubation tube 2 and the flow path in the tubular flow sensor mounting portion 4 using the positioning fixing member 5 formed in this way, the flow path in the intubation tube 2 and the tubular flow rate are adjusted. The flow path in the sensor mounting portion 4 communicates continuously without a large step.
図６は装着装置１の製造工程を拡大して示す断面図である。図６（ａ）において、挿管チューブ２を取付口３ａに取りつけた状態であり、凹部３ｄ内には、位置決め固定部材５及び管状型流量センサ装着部４は装着されていない。図６（ｂ）において位置決め固定部材５内に管状型流量センサ装着部４を装着する。図６（ｃ）において、図６（ｂ）に示す位置決め固定部材５内に管状型流量センサ装着部４が組込んだものを凹部３ｄ内に装着する。 FIG. 6 is an enlarged sectional view showing the manufacturing process of the mounting apparatus 1. In FIG. 6A, the intubation tube 2 is attached to the attachment port 3a, and the positioning fixing member 5 and the tubular flow sensor mounting portion 4 are not mounted in the recess 3d. In FIG. 6B, the tubular flow sensor mounting portion 4 is mounted in the positioning fixing member 5. In FIG. 6C, the tubular flow sensor mounting portion 4 incorporated in the positioning and fixing member 5 shown in FIG. 6B is mounted in the recess 3d.
図７は他の製造工程を拡大して示す図であり、図７（ａ）は図６（ａ）と同じ状態である。図７（ｂ）において、凹部３ｄ内に位置決め固定部材５を装着する。図７（ｃ）において、図７（ｂ）に示す位置決め固定部材５内に管状型流量センサ装着部４を装着する。 FIG. 7 is an enlarged view showing another manufacturing process, and FIG. 7 (a) is in the same state as FIG. 6 (a). In FIG. 7B, the positioning fixing member 5 is mounted in the recess 3d. In FIG. 7 (c), the tubular flow sensor mounting portion 4 is mounted in the positioning and fixing member 5 shown in FIG. 7 (b).
図８は別の製造工程を拡大して示す断面図である。図８（ａ）において、凹部３ｄ内には、管状型流量センサ装着部４は装着されていない状態であり、大径部３ｃの凹部３ｄ内周を肉厚にすることで、位置決め固定部材として機能させる。図８（ｂ）において、凹部３ｄ内に管状型流量センサ装着部４を装着することで、管状型流量センサ装着部４は挿管チューブ２内を流れる流体を検出することができる。 FIG. 8 is an enlarged sectional view showing another manufacturing process. In FIG. 8A, the tubular flow sensor mounting portion 4 is not mounted in the recess 3d, and the positioning fixing member is made thicker by making the inner periphery of the recess 3d of the large diameter portion 3c thicker. Make it work. In FIG. 8B, the tubular flow sensor mounting portion 4 can detect the fluid flowing in the intubation tube 2 by mounting the tubular flow sensor mounting portion 4 in the recess 3d.
本実施形態の挿管チューブ用装着装置の実装後の状態を図９に示す。位置決め固定部材５を用いて、コネクタ３の大径部３ｃ内の所定位置に管状型流量センサ装着部４を装着することで、挿管チューブ２を取りつけた装着装置１が完成する。 FIG. 9 shows a state after mounting of the intubation tube mounting device of the present embodiment. By using the positioning and fixing member 5 and mounting the tubular flow sensor mounting portion 4 at a predetermined position in the large diameter portion 3c of the connector 3, the mounting device 1 to which the intubation tube 2 is mounted is completed.
管状型流量センサ装着部４の出力信号と検出流量との関係例を図１０に示す。図１０に示したように、流量に応じてセンサ出力が変化しており、これを校正曲線とすることで、管状型流量センサ装着部４は未知の流量を算出できる。また、管状型流量センサ装着部４内を流れる流体の向きに寄らず、センサ出力が一致することが示されている。 An example of the relationship between the output signal of the tubular flow sensor mounting portion 4 and the detected flow rate is shown in FIG. As shown in FIG. 10, the sensor output changes according to the flow rate. By using this as a calibration curve, the tubular flow sensor mounting portion 4 can calculate an unknown flow rate. Further, it is shown that the sensor outputs coincide with each other regardless of the direction of the fluid flowing through the tubular flow sensor mounting portion 4.
装着装置１に取り付けられた挿管チューブ２を実験動物であるラビットの気道に挿管したときの実装の様子を図１１に示す。ラビットの気道に、挿管チューブ２が挿管され、管状型流量センサ装着部４の出力信号を定温度駆動回路にて検出する模式図が示されている。 FIG. 11 shows a state of mounting when the intubation tube 2 attached to the mounting device 1 is intubated into the airway of a rabbit which is an experimental animal. A schematic diagram is shown in which the intubation tube 2 is intubated into the rabbit airway and the output signal of the tubular flow sensor mounting portion 4 is detected by a constant temperature drive circuit.
本実施の形態において、挿管チューブ２をラビットの気道に挿管した後、管状型流量センサ装着部４で、直接、ラビットの気道での呼気吸気特性を評価したときの結果を図１２に示す。流量波形のプラス側が呼気を、そしてマイナス側が吸気を示している。この結果は、装着装置１内の管状型流量センサ装着部４は、実際にラビットの気道での呼気吸気が定量的に評価できることを示している。 In this embodiment, after the intubation tube 2 is intubated into the rabbit airway, the result when the exhalation inhalation characteristic in the rabbit airway is directly evaluated by the tubular flow sensor mounting portion 4 is shown in FIG. The plus side of the flow waveform indicates expiration and the minus side indicates inspiration. This result shows that the tubular flow sensor mounting portion 4 in the mounting device 1 can quantitatively evaluate the exhalation inspiration in the rabbit airway.
以上、上記した実施の形態によれば、装着装置１は挿管チューブ２とコネクタ３とからなり、コネクタ３内の位置決め固定部材５を介して、挿管チューブ２内を流れる流体を計測するための管状型流量センサ装着部４を設置する。その際に、挿管チューブ２の内径「ａ」と管状型流量センサ装着部４の内径「ｂ」をほぼ同一にし、挿管チューブ２の流路を規定する内周部と流量センサ装着部４の内周部をほぼ同一にし、更に、挿管チューブ２内の流路と管状型流量センサ装着部４内の流路が連続的に大きな段差なく連通するよう、管状型流量センサ装着部４を人工呼吸器接続用チューブ３０及び挿管チューブ２間に位置決め固定部材５を用いて固定することで、管状型流量センサ装着部４及び挿管チューブ２内を流れる流体の流量を常に正確に計測することが可能となる。 As described above, according to the above-described embodiment, the mounting device 1 includes the intubation tube 2 and the connector 3, and a tubular for measuring the fluid flowing in the intubation tube 2 through the positioning fixing member 5 in the connector 3. The mold flow sensor mounting part 4 is installed. At that time, the inner diameter “a” of the intubation tube 2 and the inner diameter “b” of the tubular flow sensor mounting portion 4 are made substantially the same, and the inner circumference defining the flow path of the intubation tube 2 and the inner portion of the flow sensor mounting portion 4 The tubular flow sensor mounting portion 4 is connected to the ventilator so that the peripheral portions are substantially the same, and the flow path in the intubation tube 2 and the flow channel in the tubular flow sensor mounting portion 4 are continuously communicated without a large step. By fixing the connecting tube 30 and the intubation tube 2 using the positioning fixing member 5, it becomes possible to always accurately measure the flow rate of the fluid flowing through the tubular flow sensor mounting portion 4 and the intubation tube 2. .
その結果、以下に示す医療システムが可能となる。
（１）装着装置１に取り付けた挿管チューブ２を気管内の気道に挿入する際、気道内を流れる呼気・吸気の一部がそのまま管状型流量センサ装着部４及び挿管チューブ２内を流れることで、呼気・吸気の一部の気体流量をリアルタイムで計測することが可能となり、挿管チューブ２が正しく気管に挿入されているか否かを判断することが容易になる。
As a result, the medical system shown below becomes possible.
(1) When the intubation tube 2 attached to the attachment device 1 is inserted into the airway in the trachea, a part of the exhalation / inspiration flowing through the airway flows through the tubular flow sensor mounting portion 4 and the intubation tube 2 as it is. It becomes possible to measure the gas flow rate of a part of exhaled air / inspired in real time, and it becomes easy to determine whether or not the intubation tube 2 is correctly inserted into the trachea.
（２）自発呼吸が改善され、装着装置１及びそれに繋がれた人工呼吸器を患者から外す場合、先ず、人工呼吸器を外し、この状態で装着装置１にて流量計測すれば、患者の自発呼吸量を定量的に把握できる。すなわち、本プロセスを用いることで、患者の自発呼吸量を定量的に確認した後、気管内挿管チューブを患者から取り外すことができ、人工呼吸器を外す際の安全性を確保できる。
（その他の実施形態）
なお、本発明は上記した実施の態様に限定されるわけはなく、種々の変更が可能である。
(2) When spontaneous breathing is improved and the mounting device 1 and the ventilator connected thereto are removed from the patient, the ventilator is first removed, and if the flow rate is measured by the mounting device 1 in this state, the patient's spontaneous Respiratory volume can be grasped quantitatively. That is, by using this process, after confirming a patient's spontaneous-respiration amount quantitatively, an endotracheal intubation tube can be removed from a patient and the safety | security at the time of removing a ventilator can be ensured.
(Other embodiments)
The present invention is not limited to the embodiment described above, and various modifications can be made.
例えば、上記実施形態では、装着装置１からワイヤー状電気配線により、管状型流量センサ装着部４への電気信号の受け渡しを行っているが、管状型流量センサ装着部４上にマイクロ波受信機を装着するようにしてもよい。そして、外部からマイクロ波を供給し、管状型流量センサ装着部４との信号の受け渡しを行うという方法でもよい。挿管チューブの断面は円形でなく、楕円形状等であってもよい。 For example, in the above embodiment, the electrical signal is transferred from the mounting device 1 to the tubular flow sensor mounting portion 4 by wire-shaped electrical wiring. However, a microwave receiver is mounted on the tubular flow sensor mounting portion 4. You may make it wear. A method of supplying a microwave from the outside and exchanging signals with the tubular flow sensor mounting portion 4 may be used. The cross section of the intubation tube may not be circular but may be elliptical.
１…気管内挿管チューブ付き装着装置、２…挿管チューブ（気管内挿管チューブ）、３…コネクタ（気管内挿管チューブ用装着装置）、３ａ…取付口、３ｄ…凹部、４…管状型流量センサ装着部、５…位置決め固定部材、１０…ガラス基板、１１…シリコーンゴムシート、１２…フィルム基板、１３…感光性樹脂、１４…熱線流速計用金属ヒータ、１５…チューブ、１６…空洞構造、１７…保護膜、２０ａ…テフロン製チューブ（位置合わせ型）、２０ｂ…テフロン製チューブ（位置合わせ型）、２１…シリコーンゴムシート（外縁用枠型）、３０…人工呼吸器接続用チューブ DESCRIPTION OF SYMBOLS 1 ... Installation apparatus with endotracheal intubation tube, 2 ... Intubation tube (intratracheal intubation tube), 3 ... Connector (installation apparatus for endotracheal intubation tube), 3a ... Mounting port, 3d ... Recessed part, 4 ... Tubular flow sensor installation , 5 ... positioning fixing member, 10 ... glass substrate, 11 ... silicone rubber sheet, 12 ... film substrate, 13 ... photosensitive resin, 14 ... metal heater for hot-wire anemometer, 15 ... tube, 16 ... hollow structure, 17 ... Protective membrane, 20a ... Teflon tube (alignment type), 20b ... Teflon tube (positioning type), 21 ... Silicone rubber sheet (frame for outer edge), 30 ... Tube for ventilator connection
Claims (6)
種々のサイズの流路を有する気管内挿管チューブの流路を規定する内周部と連結できる、ほぼ同一の流路とする内周部を有する管状型流量センサ装着部を成形し、
前記気管内挿管チューブ内の流路と前記管状型流量センサ装着部内の流路が連続的に大
きな段差なく連通するよう、前記管状型流量センサ装着部を前記人工呼吸器接続用チューブ及び気管内挿管チューブ間に位置決め固定部材を用いて位置決め固定することを特徴とする気管内挿管チューブ用装着装置の製造方法。 A method for manufacturing an endotracheal intubation tube mounting device that can be connected to a ventilator connection tube on one side and removably attach an endotracheal intubation tube on the other side,
Forming a tubular flow sensor mounting portion having an inner peripheral portion that can be connected to an inner peripheral portion that defines a flow path of an endotracheal intubation tube having various sizes of flow paths,
The tubular flow sensor mounting portion is connected to the ventilator connecting tube and the air flow channel so that the flow channel in the endotracheal intubation tube and the flow channel in the tubular flow sensor mounting portion are continuously communicated without a large step. A method for manufacturing a mounting device for an endotracheal intubation tube, wherein the positioning and fixing member is positioned and fixed between the endotracheal intubation tubes.
位置合わせ用型及び外縁用枠型を用いて位置決め固定部材を成形し、当該位置決め固定部材を用いて、前記気管内挿管チューブ内の流路と前記管状型流量センサ装着部内の流路の位置合わせを行うことを特徴とする気管内挿管チューブ用装着装置の製造方法。 In the manufacturing method of the attachment device for endotracheal intubation tubes according to claim 1,
A positioning fixing member is formed using the alignment mold and the outer edge frame mold, and the alignment of the flow path in the endotracheal intubation tube and the flow path in the tubular flow sensor mounting portion is performed using the positioning fixing member. The manufacturing method of the mounting apparatus for endotracheal intubation tubes characterized by performing.
種々のサイズの流路を有する気管内挿管チューブの流路を規定する内周部と連結できる、ほぼ同一の流路に規定する内周部を有するように成形された管状型流量センサ装着部と、
前記気管内挿管チューブ内の流路と前記管状型流量センサ装着部内の流路が連続的に大きな段差なく連通するよう、前記管状型流量センサ装着部を前記人工呼吸器接続用チューブ及び気管内挿管チューブ間に配置させる位置決め固定部材とを備えることを特徴とする気管内挿管チューブ用装着装置。 An endotracheal intubation tube mounting device that can be connected to a ventilator connection tube on one side and removably attach an endotracheal intubation tube on the other side,
A tubular flow sensor mounting portion formed to have an inner peripheral portion that defines an almost identical flow path that can be connected to an inner peripheral portion that defines a flow path of an endotracheal intubation tube having various size flow paths. ,
The tubular flow sensor mounting part is connected to the ventilator connecting tube and the endotracheal intubation so that the flow path in the endotracheal intubation tube and the flow path in the tubular flow sensor mounting part are continuously communicated without a large step. A mounting device for an endotracheal intubation tube, comprising: a positioning fixing member disposed between the tubes.
前記気管内挿管チューブ用装着装置内に前記管状型流量センサ装着部を挿管するための凹部を気管内挿管チューブ用装着位置と反対位置に設け、当該凹部内に前記位置決め固定部材を用いて管状型流量センサ装着部を装着したことを特徴とする気管内挿管チューブ用装着装置。 In the endotracheal intubation tube mounting device according to claim 3,
In the endotracheal intubation tube mounting device, a recess for intubating the tubular flow sensor mounting portion is provided at a position opposite to the endotracheal intubation tube mounting position, and the positioning type fixing member is used in the recess to form a tubular type A mounting device for an endotracheal intubation tube, characterized by mounting a flow sensor mounting portion.
前記管状型流量センサ装着部に用いられる熱線流速計用金属ヒータはフィルム上に作製され、且つ、当該フィルムは、管状チューブの内壁面に沿うように実装されていることを特徴とする気管内挿管チューブ用装着装置。 The mounting device for an endotracheal intubation tube according to claim 3 or 4,
Intratracheal intubation, wherein the metal heater for a hot-wire anemometer used in the tubular flow sensor mounting portion is manufactured on a film, and the film is mounted along the inner wall surface of the tubular tube Tube mounting device.
前記管状型流量センサ装着部の流量検出部が金属ヒータからなり、且つ、熱的に絶縁された構造になっており、前記金属ヒータから前記気内挿管チューブ内を流れる流体への熱伝達量で、前記気管内挿管チューブ内を流れる流体流量を検出することを特徴とする気管内挿管チューブ用装着装置。 In the mounting device for an endotracheal intubation tube according to any one of claims 3 to 5,
The flow rate detection part of the tubular flow sensor mounting part is composed of a metal heater and is thermally insulated, and the amount of heat transferred from the metal heater to the fluid flowing in the endotracheal tube. A mounting device for an endotracheal intubation tube, wherein the flow rate of fluid flowing in the endotracheal intubation tube is detected.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2013003749A JP6265363B2 (en) | 2013-01-11 | 2013-01-11 | Endotracheal tube installation device and method for manufacturing the same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2013003749A JP6265363B2 (en) | 2013-01-11 | 2013-01-11 | Endotracheal tube installation device and method for manufacturing the same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2014133041A true JP2014133041A (en) | 2014-07-24 |
| JP6265363B2 JP6265363B2 (en) | 2018-01-24 |
Family
ID=51411816
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013003749A Active JP6265363B2 (en) | 2013-01-11 | 2013-01-11 | Endotracheal tube installation device and method for manufacturing the same |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP6265363B2 (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2019194538A (en) * | 2018-05-01 | 2019-11-07 | 国立大学法人名古屋大学 | Flow measuring device |
| CN113891736A (en) * | 2019-03-27 | 2022-01-04 | 巴黎公共救济院 | Method for designing and verifying the shape and position of a cannula for a patient by simulating insertion into the trachea |
| CN115931321A (en) * | 2022-11-02 | 2023-04-07 | 上海玮启医疗器械有限公司 | Constant-pressure flow velocity testing device and method for medical catheter |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5287851A (en) * | 1991-09-11 | 1994-02-22 | Beran Anthony V | Endotracheal tube connector with integral pneumotach transducer |
| US20080092901A1 (en) * | 2006-10-18 | 2008-04-24 | Sin-Bum Kang | Fixing device for endotracheal tube |
| JP2009168480A (en) * | 2008-01-11 | 2009-07-30 | Univ Nagoya | Flow sensor |
| US20090250059A1 (en) * | 2008-04-08 | 2009-10-08 | Pulmonetic Systems, Inc. | Flow sensor |
| US20120130297A1 (en) * | 2010-11-18 | 2012-05-24 | A Plus Medical | Stoma pad/seal ring |
-
2013
- 2013-01-11 JP JP2013003749A patent/JP6265363B2/en active Active
Patent Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5287851A (en) * | 1991-09-11 | 1994-02-22 | Beran Anthony V | Endotracheal tube connector with integral pneumotach transducer |
| US20080092901A1 (en) * | 2006-10-18 | 2008-04-24 | Sin-Bum Kang | Fixing device for endotracheal tube |
| JP2008100034A (en) * | 2006-10-18 | 2008-05-01 | Sin-Bum Kang | Fixing device for endotracheal tube |
| JP2009168480A (en) * | 2008-01-11 | 2009-07-30 | Univ Nagoya | Flow sensor |
| US20090250059A1 (en) * | 2008-04-08 | 2009-10-08 | Pulmonetic Systems, Inc. | Flow sensor |
| CA2661589A1 (en) * | 2008-04-08 | 2009-10-08 | Cardinal Health 203, Inc. | Flow sensor |
| EP2108927A1 (en) * | 2008-04-08 | 2009-10-14 | Cardinal Health 203, Inc. | Flow sensor |
| JP2009297498A (en) * | 2008-04-08 | 2009-12-24 | Cardinal Health 203 Inc | Flow sensor |
| CN101666664A (en) * | 2008-04-08 | 2010-03-10 | 卡迪纳尔健康203公司 | Flow sensor |
| US20120130297A1 (en) * | 2010-11-18 | 2012-05-24 | A Plus Medical | Stoma pad/seal ring |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2019194538A (en) * | 2018-05-01 | 2019-11-07 | 国立大学法人名古屋大学 | Flow measuring device |
| JP7084576B2 (en) | 2018-05-01 | 2022-06-15 | 国立大学法人東海国立大学機構 | Flow measuring device |
| CN113891736A (en) * | 2019-03-27 | 2022-01-04 | 巴黎公共救济院 | Method for designing and verifying the shape and position of a cannula for a patient by simulating insertion into the trachea |
| CN115931321A (en) * | 2022-11-02 | 2023-04-07 | 上海玮启医疗器械有限公司 | Constant-pressure flow velocity testing device and method for medical catheter |
| CN115931321B (en) * | 2022-11-02 | 2023-09-08 | 上海玮启医疗器械有限公司 | Constant pressure flow velocity testing device and method for medical catheter |
Also Published As
| Publication number | Publication date |
|---|---|
| JP6265363B2 (en) | 2018-01-24 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP6949796B2 (en) | Medical tubes and their manufacturing methods | |
| EP2768562B1 (en) | System for controlling delivery of respiratory gas | |
| US8522787B2 (en) | Ultrasound-based tracheal tube placement device and method | |
| EP2276535B1 (en) | Devices for sensing respiration and controlling ventilator functions | |
| US20090253995A1 (en) | Clinical monitoring in open respiratory airways | |
| WO2009129506A1 (en) | Methods and devices for sensing respiration and controlling ventilator functions | |
| US9044557B2 (en) | Tracheal tube sensor disposed on permeable membrane | |
| WO2016178141A1 (en) | Apparatus for non-invesive pulmonary ventilation and calculation method of at least one breathing signal | |
| JP6265363B2 (en) | Endotracheal tube installation device and method for manufacturing the same | |
| CN108939240A (en) | Constant temperature and humidity for autogenous cutting patient supplies oxygen anti-sputum spraying and splashing facility | |
| WO2018107567A1 (en) | Pressure indicator | |
| EP3787723B1 (en) | Non-obstructive nasal cannula | |
| CN110269989A (en) | A kind of ventilator intubation and application method | |
| JP7084576B2 (en) | Flow measuring device | |
| CN210813323U (en) | Breathing pipeline adapter | |
| CN209048852U (en) | Trachea cannula guiding device under a kind of airway wall | |
| Kawaoka et al. | Detection of both heartbeat and respiration signals from airflow at mouth by using single catheter flow sensor | |
| CN222357857U (en) | A cannula with temperature and humidity detection function at the end | |
| CN219501759U (en) | Tracheal catheter for nasopharynx temperature measurement | |
| EP4217033B1 (en) | Breath sensing with remote pressure sensor | |
| CN214074585U (en) | Visual laryngeal mask with suction and pressure measurement functions | |
| CN213252182U (en) | Nasopharyngeal airway | |
| KR102641547B1 (en) | Apparatus for extracting patient's flow ina high flow theraphy device using cannula | |
| Sueyoshi et al. | Slip-Joint Adaptor Enabling Respiratory Monitoring in Tracheal Intubation Tube | |
| CN211299979U (en) | Straight type multi-cavity high-frequency medical whistle assisting in judging position of connecting pipe conduit |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A621 | Written request for application examination |
Free format text: JAPANESE INTERMEDIATE CODE: A621 Effective date: 20160112 |
|
| A977 | Report on retrieval |
Free format text: JAPANESE INTERMEDIATE CODE: A971007 Effective date: 20161024 |
|
| A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20161122 |
|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20170123 |
|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20170202 |
|
| A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20170627 |
|
| TRDD | Decision of grant or rejection written | ||
| A01 | Written decision to grant a patent or to grant a registration (utility model) |
Free format text: JAPANESE INTERMEDIATE CODE: A01 Effective date: 20171114 |
|
| A61 | First payment of annual fees (during grant procedure) |
Free format text: JAPANESE INTERMEDIATE CODE: A61 Effective date: 20171213 |
|
| R150 | Certificate of patent or registration of utility model |
Ref document number: 6265363 Country of ref document: JP Free format text: JAPANESE INTERMEDIATE CODE: R150 |
|
| S533 | Written request for registration of change of name |
Free format text: JAPANESE INTERMEDIATE CODE: R313533 |
|
| R350 | Written notification of registration of transfer |
Free format text: JAPANESE INTERMEDIATE CODE: R350 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |