WO2022135371A1 - Near-infrared spectrum continuous esophageal tissue oxygen saturation monitor - Google Patents

Near-infrared spectrum continuous esophageal tissue oxygen saturation monitor Download PDF

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Publication number
WO2022135371A1
WO2022135371A1 PCT/CN2021/139949 CN2021139949W WO2022135371A1 WO 2022135371 A1 WO2022135371 A1 WO 2022135371A1 CN 2021139949 W CN2021139949 W CN 2021139949W WO 2022135371 A1 WO2022135371 A1 WO 2022135371A1
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Prior art keywords
balloon
oxygen saturation
tissue oxygen
esophageal tissue
saturation monitor
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PCT/CN2021/139949
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French (fr)
Chinese (zh)
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王天龙
张昕
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王天龙
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Publication of WO2022135371A1 publication Critical patent/WO2022135371A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14542—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6853—Catheters with a balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/687—Oesophagus

Definitions

  • the invention relates to the technical field of medical equipment, in particular to a near-infrared spectrum continuous esophagus tissue oxygen saturation monitor.
  • the esophageal tissue is prone to microcirculation disturbance and tissue oxygen supply and demand imbalance under perioperative stress, hypoperfusion, and surgical operations, resulting in a significant increase in the risk of esophageal anastomotic leakage after radical esophagectomy for esophageal cancer.
  • Intrathoracic infection significantly increases perioperative mortality in patients undergoing esophageal cancer surgery.
  • the incidence of anastomotic leakage after esophageal cancer surgery is 5%-10%, and the risk of anastomotic leakage is higher in high-risk, elderly and post-radiotherapy patients.
  • the esophagus, stomach, small intestine, and large intestine are all hollow organs, which are composed of four layers: mucosa, submucosa, muscularis and adventitia.
  • the arteries that distribute in the esophagus include the common carotid esophageal branch, the ascending esophageal artery, the esophageal branch of the ascending carotid cutaneous artery, and the descending esophageal artery.
  • the veins that drain blood from the upper part of the esophagus and trachea the veins that return blood to the anterior part of the esophagus and most of the tracheothoracic part of the esophagus and the tracheo-thoracic part of the blood into the esophagus and trachea venous trunk, the middle and posterior part of the esophagus and the posterior part of the tracheothoracic part, and the veins of the bronchial blood Directly into the root of the jugular vein. Esophageal cancer surgery is usually very difficult, prone to postoperative complications, and the postoperative recovery time is long. Therefore, it is very important clinically to effectively evaluate and continuously monitor the balance of oxygen supply and demand in esophageal tissue before surgery.
  • the invention provides an esophagus tissue oxygen saturation monitor, comprising a near-infrared spectrum monitoring electrode, a balloon, an in vitro monitoring component and a catheter;
  • the electrode is combined with the inner wall of the balloon, and the near-infrared spectroscopy electrode is connected with the in vitro monitoring component through a cable;
  • At least a portion of the catheter is located within the balloon, and one end of the catheter is provided with a temperature sensor.
  • the end of the conduit provided with the temperature sensor is closed.
  • the other end of the conduit is not provided with a temperature sensor, and the other end is in communication with the ambient atmosphere.
  • the near-infrared spectrum electrodes may be selected from single-beam near-infrared spectrum emission and receiving end sensing electrodes.
  • single-beam near-infrared spectrum emitting and receiving end sensing electrodes can be integrated on the electrode sheet.
  • the size of the electrode sheet is 2 cm ⁇ 4 cm.
  • the near-infrared spectroscopy electrodes are selected from near-infrared spectroscopy oxygen saturation monitoring electrodes.
  • the electrodes are attached to the inner wall of the balloon, eg glued on the inner wall of the balloon.
  • the balloon has a straight end in the center during inflation detection.
  • a plurality of sensors are further arranged in the balloon, and the sensors are connected with an external monitoring component through cables.
  • the sensors are provided with two, and the two sensors are symmetrically arranged on the inner wall of the balloon.
  • the extracted values can be compared to avoid data distortion when one side is not fully pasted with tissue.
  • the balloon is an inflatable balloon, which may comprise a balloon body, the balloon body is provided with a cavity inside, and the inner space of the cavity forms an inflation space.
  • the inflatable space changes according to the volume of the inflated gas, and preferably forms a shape conforming to the inner wall of the esophagus after inflation.
  • a plurality of said sensors are located at the straight end of said balloon.
  • the area where the sensor is located is a flat plane to ensure that the sensor and the local tissue are fully and tightly adhered, which is conducive to more effective and accurate monitoring of changes in tissue oxygen saturation.
  • the balloon includes a plurality of inflation ports, each of which is on the catheter and located inside the balloon.
  • the inflatable port is activated by an extracorporeal air pump to introduce gas into the balloon before the monitoring starts, and the gas inside the balloon is discharged after the monitoring is completed, so as to facilitate the removal of the monitoring kit, which includes an electrode and a balloon.
  • the balloon when the balloon is inflated, it is inflated by an automatic air pump of the instrument to the extent that it closely fits with the inner wall of the esophagus, and the pressure in the balloon is continuously monitored to ensure that the monitoring balloon is always in close contact with the inner wall of the esophagus combine. Avoid tissue ischemia where the pressure on the tissue wall is too high due to excessive pressure, or avoid the sensor not fully adhered to the tissue wall when the pressure is too low.
  • the balloon comprises 2 inflation ports.
  • two of the inflation ports are symmetrically arranged on the conduit.
  • a plurality of pressure sensors are arranged in the balloon, and the pressure sensors are connected with external monitoring components through cables to ensure a constant inflation pressure.
  • two pressure sensors are provided.
  • the conduit embeds the cable.
  • the catheter may be used to accommodate a cable through which the interior of the balloon may be inflated.
  • the extracorporeal monitoring part includes a data transmission part, a data processing part and a display part.
  • the near-infrared spectroscopy electrode monitoring kit is connected with the in vitro monitoring component through a cable, wherein the cable can be selected from electric wires and data transmission lines, after the monitoring kit is placed in the proximal end of the esophagus, it is connected with the monitoring kit. cable connected.
  • the esophageal tissue oxygen saturation monitor is selected from a near-infrared spectroscopy continuous esophageal tissue oxygen saturation monitor.
  • the monitoring kit after the monitoring kit is in place in the esophagus, it is connected to the external monitoring component. Start the monitor, start the inflation pump again, inflate the balloon, make the balloon adhere to the esophagus wall, start the near-infrared spectrum monitoring, turn on the control switch of the temperature sensor, and display the real-time data on the display unit, and start the continuous dynamic monitoring process.
  • the present invention also provides a continuous processing method for esophageal tissue oxygen saturation data, comprising:
  • the present invention also provides the use of the esophageal tissue oxygen saturation monitor for processing esophageal tissue oxygen saturation data.
  • the single-beam near-infrared spectrum emission and receiving end induction electrodes are integrated on the electrode sheet of 2cm ⁇ 4cm.
  • the electrode sheet is connected with the external equipment by cables, and the entire electrode sheet is attached to the inner wall of the inflatable balloon. It ensures precise fit with the inner wall of the esophagus, ensures the accuracy of data, and prevents interference from external factors.
  • the single-beam near-infrared spectrum monitoring electrode design of the present invention has the characteristics of simplicity and practicality.
  • the present invention integrates the esophagus central body temperature monitoring electrode, avoids repeated monitoring, and saves the cost of consumables.
  • Anastomotic leakage after esophageal cancer surgery is much better than that during intraoperative esophageal anastomosis. Due to surgical techniques, stress response, and circulatory disturbances, the oxygen supply and demand of the esophagus should be continuously monitored during surgery to prevent surgical operations. The imbalance of oxygen supply and demand caused by improper circulatory management, stress and circulation management can effectively solve the problem of anastomotic leakage after esophageal cancer surgery and avoid high mortality caused by anastomotic leakage.
  • the conduit and the temperature sensor are integrally formed, which is more convenient when using a monitor.
  • the monitor of the present invention can effectively and early detect local tissue hypoxia, can timely improve the imbalance of local tissue oxygen supply and demand, greatly reduce the risk of anastomotic leakage, and can reduce the incidence of leakage after esophageal surgery to 1-2 %, its clinical significance is significant, it can effectively reduce the mortality rate after esophagus cancer operation, and greatly improve the survival rate and prognosis quality of life after esophagus cancer operation.
  • FIG. 1 is a schematic structural diagram of the monitor described in Embodiment 1;
  • Fig. 2 is the structural representation when the monitor described in Embodiment 1 is placed in the esophagus;
  • FIG. 3 is a schematic structural diagram of the monitor according to Embodiment 1 when it is in a working state;
  • An esophageal tissue oxygen saturation monitor as shown in Figures 1-3 includes an electrode 8, a balloon 2, an in vitro monitoring component 7 and a catheter 1, wherein the electrode 8 includes a near-infrared spectrum electrode, and the electrode 8 is attached to It is attached to the inner wall of the balloon 2, and the near-infrared spectroscopy electrode is connected with the in vitro monitoring component 7 through a cable.
  • a part of the catheter 1 is located in the balloon 2, one end of the catheter 1 is communicated with the ambient atmosphere, and the other end is provided with a temperature sensor 4 and is integrally formed therewith.
  • the near-infrared spectrum electrode is selected from the single-beam near-infrared spectrum emission and receiving end sensing electrodes, and the single-beam near-infrared spectrum emission and receiving end sensing electrodes can be integrated on the electrode sheet.
  • the electrodes are glued to the inner wall of the balloon.
  • the near-infrared spectroscopy electrodes are selected from near-infrared spectroscopy oxygen saturation monitoring electrodes.
  • the center When the balloon is inflated for detection, the center has a straight end.
  • sensors 3 there are also two symmetrically arranged sensors 3 in the balloon, and the sensors 3 are connected to the temperature sensor 4 and external monitoring components through cables. 2 of the sensors are located on the straight end of the balloon. When two sensors monitor local tissue oxygen saturation at the same time, the extracted values can be compared to avoid data distortion when one side is not fully pasted.
  • the cable 6 is embedded in the conduit.
  • connection manners of cables and components in the present application are all conventional manners in the prior art, which will not be repeated here.
  • the balloon 3 includes two inflatable ports 10, which are symmetrically arranged on the catheter and located inside the balloon; the inflatable ports can be used to automatically inject the inside of the balloon when needed. Introduce gas, and ensure a certain pressure in the balloon through the monitoring component, and keep it constant to ensure that the balloon is closely attached to the inner wall of the esophagus, and does not cause ischemia due to pressure on the inner wall of the esophagus 5; Before the monitoring is over, the gas inside the balloon is discharged for easy removal
  • a monitoring kit including electrodes and a balloon.
  • the automatic inflation pump of the instrument inflates the balloon to the extent that it closely fits with the inner wall of the esophagus, and continuously monitors the pressure in the inflatable balloon to ensure that the monitoring cuff and the inner wall of the esophagus are always in close contact.
  • Two pressure sensors 9 are arranged in the balloon, and the pressure sensors are connected with external monitoring components through cables to ensure a constant inflation pressure.
  • the monitoring part includes a data transmission part, a data processing part and a display part.
  • the data transmission component, the data processing component and the display component are all common devices in the prior art, and will not be repeated here.
  • the monitor When the monitor is working, after placing the monitoring kit in the proper position of the esophagus, connect the cable with the external monitoring component, start the monitor, then start the air pump, and inflate the balloon through the inflation catheter to make the balloon adhere to the esophagus wall. Start the near-infrared spectrum monitoring, turn on the control switch of the temperature sensor, and display the real-time data on the display part through the electrode and the sensor, and start the continuous dynamic monitoring process.

Abstract

An esophageal tissue oxygen saturation monitor, comprising a near-infrared spectrum electrode (8), a balloon (2), an in vitro monitoring component (7), and a catheter (1), wherein the near-infrared spectrum electrode (8) is combined with the inner wall of the balloon (2), and the near-infrared spectrum electrode (8) is connected to the in vitro monitoring component (7) by means of a cable (6). At least a part of the catheter (1) is located in the balloon (2), and one end of the catheter (1) is provided with a temperature sensor (4). The esophageal tissue oxygen saturation monitor is integrated on an electrode sheet of 2 cm × 4 cm by means of a single beam near-infrared spectrum transmitting and receiving end sensing electrode, the electrode sheet is connected to an in vitro device using a cable (6), and the whole electrode sheet is attached to the inner side wall of the inflatable balloon (2), thereby ensuring precise fitting with the inner wall of the esophagus, ensuring data accuracy, and preventing external factor interference.

Description

近红外光谱连续食道组织氧饱和度监测仪Near-infrared spectroscopy continuous esophageal tissue oxygen saturation monitor
本申请要求2020年12月21日向中国国家知识产权局提交的专利申请号为202011522255.6，名称为“近红外光谱连续食道组织氧饱和度监测仪”的在先申请的优先权。所述在先申请的全文通过引用的方式结合于本申请中。This application claims the priority of the prior application with the patent application number 202011522255.6 and the title "Near Infrared Spectrum Continuous Esophageal Tissue Oxygen Saturation Monitor" filed with the State Intellectual Property Office of China on December 21, 2020. The entire contents of said prior applications are incorporated herein by reference.
技术领域technical field
本发明涉及一种医疗器械技术领域，特别涉及一种近红外光谱的连续食道组织氧饱和度监测仪。The invention relates to the technical field of medical equipment, in particular to a near-infrared spectrum continuous esophagus tissue oxygen saturation monitor.
背景技术Background technique
食道组织在围术期应激、低灌注和外科操作下极易出现微循环紊乱和组织氧供需失衡，导致食道癌根治术术后食道吻合口漏风险显著提高，术后胸腔内因食管漏导致的胸内感染使食管癌手术患者围术期死亡率显著提升。国际报道，食管癌术后吻合口漏的发生率为5％-10％，高危、高龄以及放疗后患者，吻合口漏发生的风险更高。The esophageal tissue is prone to microcirculation disturbance and tissue oxygen supply and demand imbalance under perioperative stress, hypoperfusion, and surgical operations, resulting in a significant increase in the risk of esophageal anastomotic leakage after radical esophagectomy for esophageal cancer. Intrathoracic infection significantly increases perioperative mortality in patients undergoing esophageal cancer surgery. According to international reports, the incidence of anastomotic leakage after esophageal cancer surgery is 5%-10%, and the risk of anastomotic leakage is higher in high-risk, elderly and post-radiotherapy patients.
食道、胃、小肠、大肠均属于中空性器官，均由粘膜、粘膜下层、肌层和外膜层4层结构组成。分布于食道的动脉有颈总动脉食道支、食道升动脉、颈升皮动脉食道支和食道降动脉，回流食道和气管颈段前部的静脉汇入下颌静脉，回流食道和气管颈段中后部血液的静脉汇入食道气管静脉干，回流食道胸段前部和气管胸段大部血液的静脉汇入食道气管静脉干，食道胸段中后部和气管胸段后部以及支气管血液的静脉直接汇入颈静脉根部。食道癌手术通常难度很大，易出现术后并发症，术后恢复时间较长，所以术前有效评估和实施食道组织氧供需平衡连续监测具有非常重要的临床必要性。The esophagus, stomach, small intestine, and large intestine are all hollow organs, which are composed of four layers: mucosa, submucosa, muscularis and adventitia. The arteries that distribute in the esophagus include the common carotid esophageal branch, the ascending esophageal artery, the esophageal branch of the ascending carotid cutaneous artery, and the descending esophageal artery. The veins that drain blood from the upper part of the esophagus and trachea, the veins that return blood to the anterior part of the esophagus and most of the tracheothoracic part of the esophagus and the tracheo-thoracic part of the blood into the esophagus and trachea venous trunk, the middle and posterior part of the esophagus and the posterior part of the tracheothoracic part, and the veins of the bronchial blood Directly into the root of the jugular vein. Esophageal cancer surgery is usually very difficult, prone to postoperative complications, and the postoperative recovery time is long. Therefore, it is very important clinically to effectively evaluate and continuously monitor the balance of oxygen supply and demand in esophageal tissue before surgery.
目前国际上缺乏反映食道组织氧供需平衡监测的设备和耗材，以指导全麻下的应激管理和循环管理，防止因食道氧供需失衡导致的食道手术术后吻合口漏的风险。At present, there is a lack of equipment and consumables for monitoring the balance of oxygen supply and demand in esophageal tissue in the world to guide stress management and circulation management under general anesthesia, and prevent the risk of anastomotic leakage after esophageal surgery caused by the imbalance of esophageal oxygen supply and demand.
发明内容SUMMARY OF THE INVENTION
本发明提供一种食道组织氧饱和度监测仪，包括近红外光谱监测电极、球囊、体外监控部件和导管；The invention provides an esophagus tissue oxygen saturation monitor, comprising a near-infrared spectrum monitoring electrode, a balloon, an in vitro monitoring component and a catheter;
其中，所述电极与所述球囊的内壁结合，并且所述近红外光谱电极与所述体外监控部件通过线缆连接；Wherein, the electrode is combined with the inner wall of the balloon, and the near-infrared spectroscopy electrode is connected with the in vitro monitoring component through a cable;
所述导管的至少一部分位于所述球囊内，并且所述导管的一端设置有温度感应器。At least a portion of the catheter is located within the balloon, and one end of the catheter is provided with a temperature sensor.
根据本发明的实施方案，所述导管上设置有温度感应器的一端是封闭的。According to an embodiment of the present invention, the end of the conduit provided with the temperature sensor is closed.
根据本发明的实施方案，所述导管的另一端未设置有温度感应器，并且该另一端与环境气氛连通。According to an embodiment of the present invention, the other end of the conduit is not provided with a temperature sensor, and the other end is in communication with the ambient atmosphere.
根据本发明的实施方案，所述近红外光谱电极可以选自单束近红外谱发射和接受端感应电极。例如，可以将单束近红外谱发射和接受端感应电极整合在电极片上。According to an embodiment of the present invention, the near-infrared spectrum electrodes may be selected from single-beam near-infrared spectrum emission and receiving end sensing electrodes. For example, single-beam near-infrared spectrum emitting and receiving end sensing electrodes can be integrated on the electrode sheet.
根据本发明的实施方案，所述电极片的尺寸为2cm×4cm。According to an embodiment of the present invention, the size of the electrode sheet is 2 cm×4 cm.
根据本发明的实施方案，所述近红外光谱电极选自近红外谱氧饱和度监测电极。According to an embodiment of the present invention, the near-infrared spectroscopy electrodes are selected from near-infrared spectroscopy oxygen saturation monitoring electrodes.
根据本发明的实施方案，所述电极贴附在所述球囊的内壁，例如胶粘在球囊的内壁上。According to an embodiment of the present invention, the electrodes are attached to the inner wall of the balloon, eg glued on the inner wall of the balloon.
根据本发明的实施方案，所述球囊在充气检测时，其中心具有一直型端。According to an embodiment of the present invention, the balloon has a straight end in the center during inflation detection.
根据本发明的实施方案，所述球囊内还设有多个传感器，所述传感器通过线缆与外部的监控部件相连。According to an embodiment of the present invention, a plurality of sensors are further arranged in the balloon, and the sensors are connected with an external monitoring component through cables.
根据本发明的实施方案，所述传感器设有2个，2个传感器在所述球囊内壁上对称设置。2个传感器同时监测局部组织氧饱和度时，提取的数值可以进行比对，避免一侧没有充分粘贴组织时的数据失真。According to an embodiment of the present invention, the sensors are provided with two, and the two sensors are symmetrically arranged on the inner wall of the balloon. When two sensors monitor local tissue oxygen saturation at the same time, the extracted values can be compared to avoid data distortion when one side is not fully pasted with tissue.
根据本发明的实施方案，所述球囊为可充气球囊，其可以包含囊体，所述囊体内部设置有空腔，空腔内部空间形成充气空间。优选地，所述充气空间根据所充入气体的体积而发生变化，优选在充气后形成与食道内壁贴合的形状。According to an embodiment of the present invention, the balloon is an inflatable balloon, which may comprise a balloon body, the balloon body is provided with a cavity inside, and the inner space of the cavity forms an inflation space. Preferably, the inflatable space changes according to the volume of the inflated gas, and preferably forms a shape conforming to the inner wall of the esophagus after inflation.
根据本发明的实施方案，多个所述传感器位于所述球囊的直型端。在检测仪工作时，传感器所处区域为平缓的平面，以保证传感器与局部组织充分的紧密粘贴，有利于更有效和准确地监测组织氧饱和度的变化。According to an embodiment of the present invention, a plurality of said sensors are located at the straight end of said balloon. When the detector is working, the area where the sensor is located is a flat plane to ensure that the sensor and the local tissue are fully and tightly adhered, which is conducive to more effective and accurate monitoring of changes in tissue oxygen saturation.
根据本发明的实施方案，所述球囊包含多个充气口，多个所述充气口均在所述导管上，且位于所述球囊内部。所述充气口在监测开始前由体外气泵启动向球囊内部通入气体，监测结束后排出球囊内部气体，便于取出监测套件，所述监测套件包括电极和球囊。According to an embodiment of the present invention, the balloon includes a plurality of inflation ports, each of which is on the catheter and located inside the balloon. The inflatable port is activated by an extracorporeal air pump to introduce gas into the balloon before the monitoring starts, and the gas inside the balloon is discharged after the monitoring is completed, so as to facilitate the removal of the monitoring kit, which includes an electrode and a balloon.
根据本发明实施方案，当所述球囊充气时，由仪器自动充气泵将其充气至与食道内壁紧密贴合的程度，并持续监测球囊内压力，确保监测球囊与食道内壁始终紧密贴合。避免出现压力过大造成组织壁承压过高的组织局部缺血，或避免出现压力过小时传感器没有和组织壁充分粘贴。According to the embodiment of the present invention, when the balloon is inflated, it is inflated by an automatic air pump of the instrument to the extent that it closely fits with the inner wall of the esophagus, and the pressure in the balloon is continuously monitored to ensure that the monitoring balloon is always in close contact with the inner wall of the esophagus combine. Avoid tissue ischemia where the pressure on the tissue wall is too high due to excessive pressure, or avoid the sensor not fully adhered to the tissue wall when the pressure is too low.
根据本发明的实施方案，所述球囊包含2个充气口。According to an embodiment of the present invention, the balloon comprises 2 inflation ports.
根据本发明的实施方案，2个所述充气口在导管上对称设置。According to an embodiment of the present invention, two of the inflation ports are symmetrically arranged on the conduit.
根据本发明的实施方案，球囊内设置多个压力感应器，所述压力感应器通过线缆与外部的监测部件相连，确保充气压力恒定。According to an embodiment of the present invention, a plurality of pressure sensors are arranged in the balloon, and the pressure sensors are connected with external monitoring components through cables to ensure a constant inflation pressure.
根据本发明的实施方案，所述压力感应器设有2个。According to an embodiment of the present invention, two pressure sensors are provided.
根据本发明的实施方案，所述导管内嵌所述线缆。所述导管可以用于容纳线缆，可以通过导管向所述球囊内部充气。According to an embodiment of the invention, the conduit embeds the cable. The catheter may be used to accommodate a cable through which the interior of the balloon may be inflated.
根据本发明的实施方案，所述体外监控部件包括数据传输部件、数据处理部件和显示部件。According to an embodiment of the present invention, the extracorporeal monitoring part includes a data transmission part, a data processing part and a display part.
根据本发明的实施方案，所述近红外光谱电极监测套件与所述体外监控部件通过线缆连接，其中所述线缆可以选自电线、数据传输线，在监测套件置入食道近端后与监测线缆相连。According to an embodiment of the present invention, the near-infrared spectroscopy electrode monitoring kit is connected with the in vitro monitoring component through a cable, wherein the cable can be selected from electric wires and data transmission lines, after the monitoring kit is placed in the proximal end of the esophagus, it is connected with the monitoring kit. cable connected.
根据本发明的实施方案，所述食道组织氧饱和度监测仪选自近红外光谱连续食道组织氧饱和度监测仪。According to an embodiment of the present invention, the esophageal tissue oxygen saturation monitor is selected from a near-infrared spectroscopy continuous esophageal tissue oxygen saturation monitor.
根据本发明的实施方案，将监测套件至食道适当位置后，与体外监控部件相连接。启动监测仪，再启动充气泵，对球囊充气，使球囊与食道壁贴附，启动近红外光谱监测，打开温度感应器的控制开关，并将实时数据显示在显示部件上，开始连续动态监测过程。According to an embodiment of the present invention, after the monitoring kit is in place in the esophagus, it is connected to the external monitoring component. Start the monitor, start the inflation pump again, inflate the balloon, make the balloon adhere to the esophagus wall, start the near-infrared spectrum monitoring, turn on the control switch of the temperature sensor, and display the real-time data on the display unit, and start the continuous dynamic monitoring process.
本发明还提供一种食道组织氧饱和度数据的连续处理方法，包括：The present invention also provides a continuous processing method for esophageal tissue oxygen saturation data, comprising:
(1)使用上述食道组织氧饱和度监测仪的电极采集食道组织氧饱和度数据；(1) Use the electrodes of the above-mentioned esophageal tissue oxygen saturation monitor to collect esophageal tissue oxygen saturation data;
(2)将采集到的数据通过体外监控部件进行数据处理；(2) Process the collected data through the in vitro monitoring component;
(3)将处理后的数据通过显示部件显示。(3) Display the processed data through the display part.
本发明还提供所述食道组织氧饱和度监测仪用于处理食道组织氧饱和度数据的用途。The present invention also provides the use of the esophageal tissue oxygen saturation monitor for processing esophageal tissue oxygen saturation data.
有益效果：Beneficial effects:
(1)本发明通过单束近红外谱发射和接受端感应电极，整合在2cm×4cm的电极片上，电极片使用缆线与体外设备相连，整个电极片贴敷在可充气的球囊内侧壁上，保证与食道内壁精密贴合，确保数据准确性，并防止外界因素干扰。(1) In the present invention, the single-beam near-infrared spectrum emission and receiving end induction electrodes are integrated on the electrode sheet of 2cm×4cm. The electrode sheet is connected with the external equipment by cables, and the entire electrode sheet is attached to the inner wall of the inflatable balloon. It ensures precise fit with the inner wall of the esophagus, ensures the accuracy of data, and prevents interference from external factors.
(2)本发明的单束近红外光谱监测电极设计，具有简洁、实用特点。(2) The single-beam near-infrared spectrum monitoring electrode design of the present invention has the characteristics of simplicity and practicality.
(3)本发明整合食道中心体温监测电极，避免重复监测，节约耗材费用。(3) The present invention integrates the esophagus central body temperature monitoring electrode, avoids repeated monitoring, and saves the cost of consumables.
(4)食道癌手术后的吻合口漏多优于术中食道吻合过程中，由于外科技术、应激反应以 及循环紊乱等原因所致，术中持续监测食道的氧供需状况并防止因外科操作、应激以及循环管理不当导致的氧供需失衡，可以有效解决食道癌手术后的吻合口漏问题，避免因吻合口漏导致的高发死亡率。(4) Anastomotic leakage after esophageal cancer surgery is much better than that during intraoperative esophageal anastomosis. Due to surgical techniques, stress response, and circulatory disturbances, the oxygen supply and demand of the esophagus should be continuously monitored during surgery to prevent surgical operations. The imbalance of oxygen supply and demand caused by improper circulatory management, stress and circulation management can effectively solve the problem of anastomotic leakage after esophageal cancer surgery and avoid high mortality caused by anastomotic leakage.
(5)本发明将所述导管与所述温度感应器设置为一体成型，使用监测仪时更加方便。(5) In the present invention, the conduit and the temperature sensor are integrally formed, which is more convenient when using a monitor.
(6)本发明的监测仪可以有效早期发现局部组织缺氧现象，可以及时改善局部组织氧供需失衡，大幅度降低吻合口漏的风险，能够将食道手术后漏的发生率降低到1-2％，其临床意义重大，可以有效地降低食道癌术后的死亡率，大幅度地提高食道癌术后的生存率和预后生命质量。(6) The monitor of the present invention can effectively and early detect local tissue hypoxia, can timely improve the imbalance of local tissue oxygen supply and demand, greatly reduce the risk of anastomotic leakage, and can reduce the incidence of leakage after esophageal surgery to 1-2 %, its clinical significance is significant, it can effectively reduce the mortality rate after esophagus cancer operation, and greatly improve the survival rate and prognosis quality of life after esophagus cancer operation.
附图说明Description of drawings
图1为实施例1所述的监测仪的结构示意图；1 is a schematic structural diagram of the monitor described in Embodiment 1;
图2为实施例1所述的监测仪放置于食道时的结构示意图；Fig. 2 is the structural representation when the monitor described in Embodiment 1 is placed in the esophagus;
图3为实施例1所述的监测仪工作状态时的结构示意图；3 is a schematic structural diagram of the monitor according to Embodiment 1 when it is in a working state;
其中：1、导管；2、球囊；3、传感器；4、温度感应器；5、食道；6、线缆；7、监测部件；8、电极；9、压力传感器；10、充气口。Wherein: 1. catheter; 2. balloon; 3. sensor; 4. temperature sensor; 5. esophagus; 6. cable; 7. monitoring component; 8. electrode; 9. pressure sensor; 10. inflation port.
具体实施方式Detailed ways
下文将结合具体实施例对本发明的技术方案做更进一步的详细说明。应当理解，下列实施例仅为示例性地说明和解释本发明，而不应被解释为对本发明保护范围的限制。凡基于本发明上述内容所实现的技术均涵盖在本发明旨在保护的范围内。The technical solutions of the present invention will be described in further detail below with reference to specific embodiments. It should be understood that the following examples are only for illustrating and explaining the present invention, and should not be construed as limiting the protection scope of the present invention. All technologies implemented based on the above content of the present invention are covered within the intended protection scope of the present invention.
除非另有说明，以下实施例中使用的部件均为市售商品，或者可以通过已知方法制备。Unless otherwise stated, the components used in the following examples are commercially available or can be prepared by known methods.
实施例1Example 1
如图1-3所示的一种食道组织氧饱和度监测仪，包括电极8、球囊2、体外监控部件7和导管1，其中所述电极8包括近红外光谱电极，所述电极8贴附在所述球囊2的内壁，并且所述近红外光谱电极与所述体外监控部件7通过线缆连接。所述导管1的一部分位于球囊2内，所述导管1的一端与环境气氛连通，另一端设置有温度感应器4并与其一体成型。An esophageal tissue oxygen saturation monitor as shown in Figures 1-3 includes an electrode 8, a balloon 2, an in vitro monitoring component 7 and a catheter 1, wherein the electrode 8 includes a near-infrared spectrum electrode, and the electrode 8 is attached to It is attached to the inner wall of the balloon 2, and the near-infrared spectroscopy electrode is connected with the in vitro monitoring component 7 through a cable. A part of the catheter 1 is located in the balloon 2, one end of the catheter 1 is communicated with the ambient atmosphere, and the other end is provided with a temperature sensor 4 and is integrally formed therewith.
近红外光谱电极选自单束近红外谱发射和接受端感应电极，可以将单束近红外谱发射和接受端感应电极整合在电极片上。The near-infrared spectrum electrode is selected from the single-beam near-infrared spectrum emission and receiving end sensing electrodes, and the single-beam near-infrared spectrum emission and receiving end sensing electrodes can be integrated on the electrode sheet.
所述电极胶粘在球囊的内壁上。The electrodes are glued to the inner wall of the balloon.
所述近红外光谱电极选自近红外谱氧饱和度监测电极。The near-infrared spectroscopy electrodes are selected from near-infrared spectroscopy oxygen saturation monitoring electrodes.
所述球囊在充气检测时，其中心具有一直型端。When the balloon is inflated for detection, the center has a straight end.
所述球囊内还设有2个对称设置的传感器3，所述传感器3通过线缆与温度感应器4和外部的监控部件相连。2个所述传感器位于所述球囊的直型端。2个传感器同时监测局部组织氧饱和度时，提取的数值可以进行比对，避免一侧没有充分粘贴时的数据失真。There are also two symmetrically arranged sensors 3 in the balloon, and the sensors 3 are connected to the temperature sensor 4 and external monitoring components through cables. 2 of the sensors are located on the straight end of the balloon. When two sensors monitor local tissue oxygen saturation at the same time, the extracted values can be compared to avoid data distortion when one side is not fully pasted.
所述导管内嵌所述线缆6。The cable 6 is embedded in the conduit.
本申请中线缆与各部件的连接方式均为现有技术中惯用的方式，这里不再赘述。The connection manners of cables and components in the present application are all conventional manners in the prior art, which will not be repeated here.
所述球囊3包含2个充气口10，2个所述充气口10在所述导管上对称设置，且位于所述球囊内部；所述充气口可在需要时用于自动向球囊内部通入气体，并通过监控部件确保一定囊内压力，并保持恒定，确保气囊与食道内壁紧密贴附，并不造成食道5内壁受压造成缺血；监测结束前排出球囊内部气体，便于取出监测套件，所述监测套件包括电极和球囊。The balloon 3 includes two inflatable ports 10, which are symmetrically arranged on the catheter and located inside the balloon; the inflatable ports can be used to automatically inject the inside of the balloon when needed. Introduce gas, and ensure a certain pressure in the balloon through the monitoring component, and keep it constant to ensure that the balloon is closely attached to the inner wall of the esophagus, and does not cause ischemia due to pressure on the inner wall of the esophagus 5; Before the monitoring is over, the gas inside the balloon is discharged for easy removal A monitoring kit including electrodes and a balloon.
当所述球囊充气时，由仪器自动充气泵将球囊充气至与食道内壁紧密贴合的程度，并持续监测充气囊内压力，确保监测套囊与食道内壁始终紧密贴合。When the balloon is inflated, the automatic inflation pump of the instrument inflates the balloon to the extent that it closely fits with the inner wall of the esophagus, and continuously monitors the pressure in the inflatable balloon to ensure that the monitoring cuff and the inner wall of the esophagus are always in close contact.
球囊内设置2个压力感应器9，所述压力感应器通过线缆与外部的监测部件相连，确保充气压力恒定。Two pressure sensors 9 are arranged in the balloon, and the pressure sensors are connected with external monitoring components through cables to ensure a constant inflation pressure.
所述监控部件包括数据传输部件、数据处理部件和显示部件。所述数据传输部件、数据处理部件和显示部件均为现有技术中常见的装置，这里不再赘述。The monitoring part includes a data transmission part, a data processing part and a display part. The data transmission component, the data processing component and the display component are all common devices in the prior art, and will not be repeated here.
当监测仪工作时，将监测套件放置至食道适当位置后，与体外监控部件线缆连接，启动监测仪，再启动充气泵，通过充气导管对球囊充气，使球囊与食道壁贴附，启动近红外光谱监测，打开温度感应器的控制开关，通过电极和传感器，可将实时数据显示在显示部件上，开始连续动态监测过程。When the monitor is working, after placing the monitoring kit in the proper position of the esophagus, connect the cable with the external monitoring component, start the monitor, then start the air pump, and inflate the balloon through the inflation catheter to make the balloon adhere to the esophagus wall. Start the near-infrared spectrum monitoring, turn on the control switch of the temperature sensor, and display the real-time data on the display part through the electrode and the sensor, and start the continuous dynamic monitoring process.
以上，对本发明的实施方式进行了说明。但是，本发明不限定于上述实施方式。凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。The embodiments of the present invention have been described above. However, the present invention is not limited to the above-described embodiments. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims (10)

  1. 一种食道组织氧饱和度监测仪，其特征在于，包括近红外光谱电极、球囊、体外监控部件和导管；An esophagus tissue oxygen saturation monitor, characterized in that it includes a near-infrared spectrum electrode, a balloon, an in vitro monitoring component and a catheter;
    其中，所述电极与所述球囊的内壁结合，并且所述近红外光谱电极与所述体外监控部件通过线缆连接；Wherein, the electrode is combined with the inner wall of the balloon, and the near-infrared spectroscopy electrode is connected with the in vitro monitoring component through a cable;
    所述导管的至少一部分位于所述球囊内，并且所述导管的一端设置有温度感应器；At least a part of the catheter is located in the balloon, and one end of the catheter is provided with a temperature sensor;
    优选地，所述球囊为可充气球囊。Preferably, the balloon is an inflatable balloon.
  2. 根据权利要求1所述的食道组织氧饱和度监测仪，其特征在于，所述导管上设置有温度感应器的一端是开放或封闭的。The esophageal tissue oxygen saturation monitor according to claim 1, wherein the end of the catheter provided with the temperature sensor is open or closed.
    优选地，所述导管的另一端未设置有温度感应器，并且该另一端与环境气氛连通。Preferably, the other end of the conduit is not provided with a temperature sensor, and the other end communicates with the ambient atmosphere.
    优选地，近红外光谱电极可以选自单束近红外谱发射和接受端感应电极；例如，可以将单束近红外谱发射和接受端感应电极整合在电极片上。Preferably, the near-infrared spectrum electrodes can be selected from single-beam near-infrared spectrum emitting and receiving end sensing electrodes; for example, the single-beam near-infrared spectrum emitting and receiving end sensing electrodes can be integrated on the electrode sheet.
    优选地，所述电极片的尺寸为2cm×4cm。Preferably, the size of the electrode sheet is 2cm×4cm.
    优选地，所述近红外光谱电极选自近红外谱氧饱和度监测电极。Preferably, the near-infrared spectroscopy electrodes are selected from near-infrared spectroscopy oxygen saturation monitoring electrodes.
    优选地，所述电极贴附在所述球囊的内壁；例如，所述电极胶粘在球囊的内壁上。Preferably, the electrodes are attached to the inner wall of the balloon; for example, the electrodes are glued on the inner wall of the balloon.
  3. 根据权利要求1所述的食道组织氧饱和度监测仪，其特征在于，所述球囊在充气检测时，其中心具有一直型端。The esophageal tissue oxygen saturation monitor according to claim 1, characterized in that, when the balloon is inflated for detection, the center has a straight end.
  4. 根据权利要求1所述的食道组织氧饱和度监测仪，其特征在于，所述球囊内还设有多个传感器，所述传感器通过线缆与温度感应器和外部的监控部件相连。The esophageal tissue oxygen saturation monitor according to claim 1, wherein a plurality of sensors are further provided in the balloon, and the sensors are connected to a temperature sensor and an external monitoring component through cables.
    优选地，所述传感器设有2个，2个传感器在所述球囊内壁上对称设置。2个传感器同时监测局部组织氧饱和度时，提取的数值更可靠和趋于准确，避免一侧没有充分粘贴时的失真。Preferably, two sensors are provided, and the two sensors are symmetrically arranged on the inner wall of the balloon. When two sensors monitor local tissue oxygen saturation at the same time, the extracted value is more reliable and tends to be accurate, avoiding distortion when one side is not fully pasted.
  5. 根据权利要求4所述的食道组织氧饱和度监测仪，其特征在于，多个所述传感器位于所述球囊的直型端。The esophageal tissue oxygen saturation monitor of claim 4, wherein a plurality of the sensors are located at the straight end of the balloon.
  6. 根据权利要求1所述的食道组织氧饱和度监测仪，其特征在于，所述导管内嵌所述线缆。The esophageal tissue oxygen saturation monitor according to claim 1, wherein the cable is embedded in the catheter.
  7. 根据权利要求1所述的食道组织氧饱和度监测仪，其特征在于，所述球囊包含多个充气口，多个所述充气口均在所述导管上，且位于所述球囊内部。The esophageal tissue oxygen saturation monitor according to claim 1, wherein the balloon comprises a plurality of inflation ports, and the plurality of inflation ports are all on the catheter and located inside the balloon.
    优选地，所述球囊包含2个充气口。Preferably, the balloon contains 2 inflation ports.
    优选地，2个所述充气口在导管上对称设置。Preferably, the two inflation ports are symmetrically arranged on the conduit.
  8. 根据权利要求1所述的食道组织氧饱和度监测仪，其特征在于，球囊内设置多个压力感应器，所述压力感应器通过线缆与外部的监测部件相连。The esophageal tissue oxygen saturation monitor according to claim 1, wherein a plurality of pressure sensors are arranged in the balloon, and the pressure sensors are connected to external monitoring components through cables.
    优选地，所述压力感应器设有2个。Preferably, there are two pressure sensors.
  9. 根据权利要求1所述的食道组织氧饱和度监测仪，其特征在于，所述体外监控部件包括数据传输部件、数据处理部件和显示部件。The esophagus tissue oxygen saturation monitor according to claim 1, wherein the in vitro monitoring component comprises a data transmission component, a data processing component and a display component.
    优选地，所述近红外光谱电极监测套件与所述体外监控部件通过线缆连接，其中所述线缆可以选自电线、数据传输线，在监测套件置入食道近端后与监测线缆相连；Preferably, the near-infrared spectroscopy electrode monitoring kit is connected with the in vitro monitoring component through a cable, wherein the cable can be selected from electric wires and data transmission lines, and is connected to the monitoring cable after the monitoring kit is placed in the proximal end of the esophagus;
    所述监测套件包括电极和球囊。The monitoring kit includes electrodes and a balloon.
    优选地，所述食道组织氧饱和度监测仪选自近红外光谱连续食道组织氧饱和度监测仪。Preferably, the esophageal tissue oxygen saturation monitor is selected from a near-infrared spectrum continuous esophageal tissue oxygen saturation monitor.
    优选地，将监测套件至食道适当位置后，与体外监控部件相连接。Preferably, after the monitoring kit is placed in the proper position of the esophagus, it is connected with the external monitoring component.
  10. 权利要求1-9任一项所述的食道组织氧饱和度监测仪检测到的数据的连续处理方法，其特征在于，包括：The continuous processing method of data detected by an esophageal tissue oxygen saturation monitor according to any one of claims 1-9, characterized in that, comprising:
    (1)使用上述食道组织氧饱和度监测仪的电极采集直肠组织氧饱和度数据；(1) Use the electrodes of the above-mentioned esophageal tissue oxygen saturation monitor to collect rectal tissue oxygen saturation data;
    (2)将采集到的数据通过体外监控部件进行数据处理；(2) Process the collected data through the in vitro monitoring component;
    (3)将处理后的数据通过显示部件显示。(3) Display the processed data through the display part.
    优选地，权利要求1-9任一项所述食道组织氧饱和度监测仪用于处理食道组织氧饱和度数据的用途。Preferably, the esophageal tissue oxygen saturation monitor according to any one of claims 1-9 is used for processing esophageal tissue oxygen saturation data.
PCT/CN2021/139949 2020-12-21 2021-12-21 Near-infrared spectrum continuous esophageal tissue oxygen saturation monitor WO2022135371A1 (en)

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