WO2021179152A1 - 一种医用检测设备及医用检测设备的测量部件 - Google Patents

一种医用检测设备及医用检测设备的测量部件 Download PDF

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Publication number
WO2021179152A1
WO2021179152A1 PCT/CN2020/078529 CN2020078529W WO2021179152A1 WO 2021179152 A1 WO2021179152 A1 WO 2021179152A1 CN 2020078529 W CN2020078529 W CN 2020078529W WO 2021179152 A1 WO2021179152 A1 WO 2021179152A1
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Prior art keywords
component
measuring
dye
medical detection
measuring component
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PCT/CN2020/078529
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English (en)
French (fr)
Inventor
段晓东
张书鹏
刘雷
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上海安翰医疗技术有限公司
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Application filed by 上海安翰医疗技术有限公司 filed Critical 上海安翰医疗技术有限公司
Priority to PCT/CN2020/078529 priority Critical patent/WO2021179152A1/zh
Priority to US17/910,836 priority patent/US20240023845A1/en
Priority to JP2022554703A priority patent/JP2023517970A/ja
Priority to EP20923984.7A priority patent/EP4119051A4/en
Priority to KR1020227035269A priority patent/KR20220153058A/ko
Publication of WO2021179152A1 publication Critical patent/WO2021179152A1/zh

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    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/044—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances for absorption imaging
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    • A61B1/00002—Operational features of endoscopes
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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/34—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
    • C12Q1/37—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving peptidase or proteinase
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Definitions

  • This application relates to the technical field of medical devices, and in particular to a medical detection device and a measuring component of the medical detection device.
  • endoscopic devices are usually used to visually observe the digestive tract mucosa, but due to the limitation of technology integration, endoscopes on the market can only perform image observation of the digestive tract mucosa, and cannot obtain other useful information in the digestive tract. Therefore, the existing endoscope device has a single function and cannot complete accurate detection of the digestive tract.
  • the present application provides a medical detection equipment and a measurement component of the medical detection equipment, and the detection accuracy of the medical detection equipment is relatively high.
  • the first aspect of the embodiments of the present application provides a medical detection device, and the medical detection device includes:
  • the measuring component is installed on the outer wall of the housing and is used to measure the concentration of the parameter to be measured in the external environment of the housing.
  • the measurement component includes a polyion gel and a dye, and the dye is filled in the polyion gel;
  • the dye can change color.
  • the measurement component includes one or more of a pH measurement component, an occult blood measurement component, a pepsin measurement component, and a trypsin measurement component.
  • the dye of the pH measuring component is a pH-sensitive dye, and the pH-sensitive dye can change color in an environment with different pH values.
  • the hydrogen ions in the external environment of the housing can enter the pH measurement component through the polyion gel, and the hydrogen ions in the pH measurement component can be condensed by the polyion gel.
  • Glue enters the environment outside the casing;
  • the pH-sensitive dye can be combined or separated with hydrogen ions to form a dynamic equilibrium.
  • the dye of the occult blood measuring component includes methylene blue dye, and the methylene blue dye can change color in an environment with different occult blood concentrations.
  • hemoglobin in the external environment of the housing can be combined and reacted with the polyion gel and the methylene blue dye in the occult blood measuring component;
  • the methylene blue dye can display colors through an oxidation-reduction reaction, and when the concentration of the hemoglobin is different, the colors displayed by the methylene blue dye are different.
  • the dye of the pepsin measuring component includes bromophenol blue dye, and the bromophenol blue dye can change color in an environment with different pepsin concentrations.
  • the pepsin in the external environment of the housing can be combined with the polyion gel and the bromophenol blue dye in the pepsin measurement component;
  • the light scattering signal of the combined bromophenol blue dye changes and shows different colors, and when the concentration of pepsin is different, the color of the bromophenol blue dye is different.
  • the dye of the trypsin measurement component includes bromocresol purple dye, and the bromocresol purple dye can change color in an environment with different trypsin concentrations.
  • the trypsin in the external environment of the housing can be combined with the polyion gel and bromocresol purple dye in the trypsin measurement component;
  • the volume of the combined bromocresol purple dye changes, and its light scattering signal changes, showing different colors, and when the concentration of trypsin is different, the color of the bromocresol purple dye is different.
  • the arrangement of the measuring components on the outer wall of the housing is a partition arrangement or an alternate arrangement.
  • the medical detection equipment includes a plurality of the measuring components
  • the measuring ranges of the measuring components are not completely the same, and/or the resolutions of the measuring components are not completely the same.
  • the housing includes a transparent part
  • the medical detection equipment further includes an imaging component located in the inner cavity of the housing, and the imaging component can observe the environment outside the housing through the transparent part.
  • the housing includes a first end portion and a second end portion opposite to each other in the axial direction, and both the first end portion and the second end portion include the transparent portion;
  • the medical detection equipment includes two imaging components, and the two imaging components are respectively arranged corresponding to the two transparent parts;
  • the measuring component is installed on the outer wall of the first end or the second end; or,
  • the medical detection equipment includes at least a first measurement component and a second measurement component, and the first measurement component and the second measurement component have different ranges.
  • first measurement component and the second measurement component One is installed on the outer wall of the first end, and the other is installed on the outer wall of the second end.
  • the medical detection equipment further includes a data transmission component
  • the image component includes a lens and an image sensor, and the lens and the image sensor are connected by a mechanical structure and/or glue;
  • the image sensor is electrically connected or signal connected with the data transmission component, and the lens and the data transmission component are connected by a mechanical structure and/or glue.
  • the lens is installed in the inner cavity of the housing, and the lens has an effective imaging angle ⁇ 1, and the transparent portion can cover the space where the effective imaging angle ⁇ 1 is located;
  • the image sensor has a display image angle ⁇ 2, the transparent portion can cover the space where the display image angle ⁇ 2 is located, and ⁇ 1> ⁇ 2;
  • the measuring component is installed on the outer wall of the housing and is located in the space between the effective imaging angle ⁇ 1 and the display image angle ⁇ 2;
  • the data transmission component can read the data of the measurement component.
  • the lens is installed in the inner cavity of the housing, and the lens has an effective imaging angle ⁇ 1, and the transparent portion can cover the space where the effective imaging angle ⁇ 1 is located;
  • the image sensor has a display image angle ⁇ 2, the transparent portion can cover the space where the display image angle ⁇ 2 is located, and ⁇ 1> ⁇ 2;
  • the measuring component is installed on the outer wall of the housing and is located in the space occupied by the display image angle ⁇ 2;
  • the image sensor can recognize the data of the measurement part.
  • the measurement component is located in the middle of the space occupied by the display image angle ⁇ 2.
  • the measuring component is pasted on the outer wall of the housing through a transparent glue.
  • the measuring component is also adhered to the outer wall of the housing through an edge sealing glue, and the edge sealing glue covers the outer edge of the measuring component.
  • the shell is a capsule structure
  • the medical detection equipment is a capsule endoscope.
  • a second aspect of the embodiments of the present application provides a measurement component of a medical detection device, the measurement component includes a polyion gel and a dye, and the dye is filled in the polyion gel;
  • the dye can change color.
  • the medical detection equipment in the embodiments of the present application can detect various parameters in the digestive tract (including pH, occult blood concentration, pepsin concentration, trypsin concentration, etc.) by providing measurement components, thereby improving the medical detection equipment The accuracy of the detection results of the digestive tract, and enables the medical detection equipment to have multiple functions, improving its practicability.
  • FIG. 1 is a schematic structural diagram of a first specific embodiment of the medical detection equipment provided by this application;
  • Figure 2 is an exploded view of Figure 1;
  • Figure 3 is a partial cross-sectional view of Figure 1;
  • Fig. 4 is a schematic diagram of the structure of the measuring component in Fig. 1;
  • Fig. 5 is a schematic structural diagram of the connection between the measuring component and the housing in Fig. 4;
  • FIG. 6 is a schematic structural diagram of the medical detection equipment provided by this application in a second specific embodiment
  • FIG. 7 is a schematic structural diagram of the medical detection equipment provided by this application in a third specific embodiment.
  • FIG. 8 is a schematic structural diagram of the medical detection equipment provided by this application in a fourth specific embodiment.
  • FIG. 9 is a schematic structural diagram of the medical detection equipment provided by this application in a fifth specific embodiment.
  • FIG. 10 is a top view of the medical detection equipment provided by this application in a sixth specific embodiment.
  • FIG. 11 is a top view of the medical detection equipment provided by this application in a seventh specific embodiment
  • FIG. 12 is a top view of the medical detection equipment provided by this application in an eighth specific embodiment.
  • FIG. 13 is a top view of the medical detection equipment provided by this application in a ninth specific embodiment.
  • the medical detection device includes a housing 1 and a measuring component 3.
  • the housing 1 may further include an upper housing 12 and a lower housing 13.
  • the upper shell 12 and the lower shell 13 are fixedly connected and enclose the inner cavity of the shell 1;
  • the measuring component 3 is installed on the outer wall of the shell 1 to measure the parameters of the external environment of the shell 1.
  • the medical detection equipment when used for gastrointestinal detection, it can be used to detect the pH value, occult blood concentration, pepsin concentration, trypsin concentration and other parameters of the digestive tract.
  • the medical detection device in the embodiment of the present application can detect various parameters in the digestive tract (including pH, occult blood concentration, pepsin concentration, trypsin concentration, etc.) by setting the measuring component 3, thereby improving the medical detection.
  • the measuring component 3 in the embodiment of the present application may include one or more of a pH measuring component 33, an occult blood measuring component 34, a pepsin measuring component 35, and a trypsin measuring component 36, wherein the pH measuring component 33 can For measuring the pH of the external environment (for example, digestive tract) of the housing 1, the occult blood measuring part 34 can be used to measure whether there is occult blood and the concentration of occult blood in the external environment (for example, the digestive tract) of the housing 1, the pepsin measuring part 35 For measuring the concentration of pepsin in the external environment of the housing 1 (for example, the digestive tract), the trypsin measuring part 36 is used for measuring the concentration of trypsin in the external environment of the housing 1 (for example, the digestive tract).
  • the pH measuring component 33 can For measuring the pH of the external environment (for example, digestive tract) of the housing 1
  • the occult blood measuring part 34 can be used to measure whether there is occult blood and the concentration of occ
  • the measurement of various parameters of the digestive tract can be achieved through the various measurement components 3 described above, thereby improving the accuracy of the detection results of the medical detection equipment.
  • the medical detection equipment in the embodiments of the present application does not necessarily include the above-mentioned four measurement components 3, and may include only one of them or any combination thereof.
  • the measuring component 3 may include a body portion 31 and a glue material 32, wherein the glue material 32 is a transparent glue material and has biocompatibility, so that the measuring component can be assembled through the glue material 32
  • the main body 31 of 3 is attached to the housing 1 of the medical testing equipment.
  • the adhesive material 32 can be a transparent back adhesive, and is attached to the transparent portion 11 of the housing 1.
  • the transparent adhesive can be, but is not limited to, medical grade UV adhesive, medical instant adhesive, or medical adhesive.
  • the edge sealing glue 14 can be, but is not limited to, medical grade UV glue, medical instant adhesive, or medical back glue.
  • the reliability of the connection between the measuring component 3 and the housing 1 can be further improved, and the use and installation process can be reduced. The risk of the component 3 falling off the housing 1 is measured.
  • the measurement component 3 may include polyion gel and dye, and the dye can change color.
  • the measuring component 3 may be a thin film structure, and its shape may be any shape such as a circle, a square, a polygon, etc. The specific shape of the measuring component 3 is not limited in this application.
  • the body portion 31 of the measuring component 3 includes a polyion gel and a dye, wherein the dye can change color, the polyion gel is a solid substance formed by polymer cross-linking polymerization, and the dye is filled in In the polyion gel, due to the strong ionic interaction between the polyion gel and the dye ions, the dye ions can be kept in the polyion gel.
  • the above-mentioned polyion gel contains an ion exchange membrane structure, and the ion exchange membrane is a polymer membrane that contains ion groups and has selective permeability to ions in the solution.
  • the ions of the substance to be measured in the solution such as hydrogen ions
  • the concentration of the ions of the substance to be measured (for example, hydrogen ion) in the solution is the same as the concentration of the ion (for example, hydrogen ion) of the substance to be detected in the polyion gel.
  • the concentration of hydrogen ions when the concentration of hydrogen ions increases, it can diffuse into the polyion gel, thereby increasing the concentration of ions (such as hydrogen ions) of the substance to be measured combined with the dye, corresponding to the concentration of the substance to be measured (such as the concentration of hydrogen ions) , The pH value of the solution); when the concentration of the ions (such as hydrogen ions) of the substance to be measured in the solution decreases, the ions (such as hydrogen ions) of the substance to be measured in the polyion gel can diffuse into the solution, thereby reducing
  • the concentration of ions (for example, hydrogen ions) of the substance to be measured combined with the dye corresponds to the concentration of another substance to be measured (for example, the concentration of hydrogen ions, that is, the pH value of the solution).
  • the dye in the measuring component 3 can be combined with or separated from the ions (for example, hydrogen ions) of the substance to be measured to form a dynamic equilibrium, and continuous measurement of the concentration of the substance to be measured can be realized.
  • ions for example, hydrogen ions
  • the measuring component 3 including polyion gel and dye can be easily integrated (for example, pasted) with medical testing equipment (such as capsule endoscopes), and is compatible with the hardware of the medical testing equipment after integration.
  • medical testing equipment such as capsule endoscopes
  • No need to carry out secondary packaging only need to modify the related software to realize the pH measurement at the same time as the endoscopy, so as to improve the accuracy of the detection.
  • the ions of the substance to be detected in the solution can pass through the polyion gel and bind to the dye, and the ions of the substance to be detected combined with the dye can also pass through the polyion gel.
  • the measuring component 3 can form a dynamic balance with the ions of the substance to be detected, so as to realize continuous measurement of the concentration of the substance to be detected.
  • the measurement component 3 also contributes to industrialization and cost reduction.
  • the measurement component 3 when the medical detection device is used to measure the pH value of the digestive tract, the measurement component 3 includes at least a pH measurement component 33, wherein the body portion 31 of the pH measurement component 33 may include polyion coagulation. Gel and pH-sensitive dyes, wherein when the concentration of hydrogen ions in the solution is different, the pH-sensitive dyes have different colors.
  • the prior art when detecting the internal pH of the human body, the prior art mainly adopts the following two methods.
  • One is a pH electrode, which can be directly tested by using materials that are sensitive to hydrogen ions. It can output the pH value of the environment to be measured with high accuracy, such as antimony electrode.
  • Another solution is to judge the pH of the environment to be tested by color changes, with low accuracy, such as traditional pH test papers and pH indicators.
  • the sensor When performing pH measurement by electrochemical methods, the sensor is more complicated, and the reference electrode and the test electrode need to be packaged together, and at the same time, it is necessary to ensure that there is an ion channel between it and the test environment.
  • glass electrodes, antimony electrodes, and hydrogen ion sensitive field effect transistors (H+SFET) can all meet application requirements.
  • H+SFET hydrogen ion sensitive field effect transistors
  • an antimony electrode is used as a pH electrode, there is potential biological toxicity.
  • the method of measuring pH by color change has a long history, but this method cannot continuously measure different pH environments, and it cannot be integrated into a capsule endoscope device for continuous pH measurement.
  • the medical testing equipment in this application can obtain the pH information of the digestive tract, that is, the medical testing equipment integrates the pH measurement component 33.
  • the integration process can be simplified. And reduce integration costs.
  • the pH measuring component 33 including polyion gel and pH sensitive dye does not need to use electrochemical electrodes, and can be easily integrated (such as pasted) with medical detection equipment (such as capsule endoscopes), and integrated with the hardware of the medical detection equipment.
  • medical detection equipment such as capsule endoscopes
  • the hydrogen ions in the solution can penetrate the polyion gel and combine with the pH-sensitive dye, and the hydrogen ions combined with the pH-sensitive dye can also penetrate the polyion gel, so that
  • the pH measuring component 33 can form a dynamic balance with hydrogen ions to realize continuous measurement of pH.
  • the pH measuring component 33 can also measure the pH of the oral cavity, intestinal tract and other organs, and can display different colors according to the pH of each organ.
  • the pH measurement component 3 also contributes to industrialization and cost reduction.
  • a pH measurement component 33 can meet the pH measurement of 1, 5, 7, and 8, and another pH measurement component 33 can meet the measurement of pH 2, 3, 4, and 6. Therefore, when the medical measurement component When the above-mentioned two pH measuring components 33 are included, the pH measurement in the range of 1-8 can be satisfied, and the resolution of the pH value of 0.5-1 can be satisfied.
  • the difference between the above two pH measuring components 33 is that the two types of sensitive dyes are different, and the polyion gels of the two can be the same.
  • the measurement component 3 when the medical detection device is used to measure whether there is occult blood in the digestive tract and the concentration of occult blood, the measurement component 3 includes at least an occult blood measurement component 34, wherein the body portion 31 of the occult blood measurement component 34 It may include polyion gel and methylene blue dye, wherein when the concentration of hemoglobin in the solution is different, the methylene blue dye has a different color.
  • the first solution is the occult blood bead method.
  • the basic principle is to swallow a capsule with a thin thread. The capsule is pulled out through the thin thread after absorbing the gastric juice at the tail, and then drips onto the capsule with the gastric juice. Chromogenic agent, observe the color change to determine whether there is occult blood.
  • the second scheme is to detect the occult blood condition of the digestive tract by detecting the bleeding in the stool through the occult blood test paper.
  • Option 1 is only applicable to the occult blood test of the upper gastrointestinal tract, and it is an invasive test. The test process will cause uncomfortable reactions such as vomiting.
  • Option 2 is only suitable for the detection of occult blood in the lower gastrointestinal tract, especially the colorectal detection, and it is susceptible to hemorrhoids and other factors that can lead to false positives in the detection.
  • the methylene blue dye can be The ions remain in the polyion gel and do not leak out, and the methylene blue dye is a biological stain, which has an oxidizing effect on hemoglobin.
  • the methylene blue dye is reduced by hemoglobin and turns from blue to colorless , And according to the different hemoglobin concentration, the shade of blue is different, the occult blood can be quantitatively detected through the color change.
  • the methylene blue dye is a non-toxic dye, and its oxidized type is blue, and its reduced type is colorless.
  • the cell In the environment of high concentration of hemoglobin, due to cell metabolism, the cell has a strong reducing ability. Under the action of glucose-6-phosphate dehydrogenase, the methylene blue dye can be changed from blue oxidized type to colorless Or light yellow reduced type. In a low-concentration hemoglobin environment, the cells in this environment have no or very weak reducing ability. At this time, the methylene blue dye is blue or light blue.
  • the methylene blue dye when the methylene blue dye is blue or light blue, it means that the hemoglobin in the environment (such as the digestive tract) is at a low concentration, and when the methylene blue dye is colorless or light yellow, it means the environment (such as the digestive tract) The hemoglobin in it is a high concentration.
  • the occult blood measuring component 34 in this embodiment can realize continuous measurement, and can measure the occult blood concentration of different organs. For example, it can measure the occult blood of organs such as stomach and intestine.
  • the medical detection device in the embodiment of the present application integrates the occult blood measurement component 34.
  • the integration process can be simplified and the cost can be reduced.
  • the medical detection device can achieve non-invasiveness. Detection, and the measurement accuracy is high.
  • the measuring component 3 when the medical detection device is used to measure the concentration of pepsin in the digestive tract, the measuring component 3 at least includes a pepsin measuring component 35, wherein the body portion 31 of the pepsin measuring component 35 can be It includes polyion gel and bromophenol blue dye, wherein when the concentration of pepsin in the solution (such as the digestive tract) is different, the bromophenol blue dye has different colors.
  • Pepsin in human gastric juice has become a biological sign of gastritis and gastric cancer.
  • intestinal metaplasia, dysplasia and gastric cancer the secretion of pepsin will be reduced; when infected with Helicobacter pylori or with gastric ulcer, duodenum Intestinal ulcers and other diseases, the pepsin value increases.
  • a large number of statistical analyses show that the changes in serum pepsinogen content are related to gastric diseases, and it is believed that the detection of serum pepsinogen plays an important role in the early diagnosis of gastric cancer.
  • the existing technology mainly uses three methods to detect the content of pepsin.
  • the first is the in vitro detection of serum collection. This method is to collect the subject's serum for analysis. Analyze the specific content of pepsin. Therefore, the measured pepsin is a single test, which has limitations for real-time monitoring of the gastric juice content in gastric juice.
  • pepsin only works in an acidic environment and loses its activity when pH>6 . In the in vitro environment, it is easy to be affected by the environment and cause the test results to be inaccurate.
  • the second is to rely on gastroscopy to confirm the diagnosis, but gastroscopy is painful, expensive, limited by the level of doctors, and patient acceptance is low.
  • the third is the detection method of pepsin chemiluminescence immunoassay kit, which adopts pepsin chemiluminescence immunoassay kit, which includes pepsin antigen calibrator, sample collection solution, sample diluent, pepsin antibody-coated micro Well plate, pepsin antibody marker, chemiluminescence substrate solution, concentrated washing solution.
  • the kit can detect the content of pepsin in gastric juice, esophageal contents, and throat secretions, and judge whether there is gastroesophageal reflux according to whether pepsin can be detected, and judge whether there is gastroesophageal reflux according to the content of pepsin. The effect and its condition changes.
  • this method can perform pepsin detection, the process is complicated, requires high operators and detection equipment, and the cost is not low.
  • the pepsin measuring component 35 including polyionic gel and bromophenol blue dye when used, since the polyionic liquid gel and bromophenol blue dye ions have a strong ionic interaction, it can make The bromophenol blue dye ions remain in the gel without leakage. And bromophenol blue dye is a kind of biological stain.
  • the bromophenol blue dye binds with pepsin in a non-covalent bond, the hydrophobic core of pepsin and the non-polar group of bromophenol blue dye
  • the combined aggregate volume is larger than the volume of the bromophenol blue dye itself, so that the combined molar absorption coefficient and the light scattering signal change, and then display different colors, and its signal intensity is consistent with the particle in the unit volume.
  • the number that is, the pepsin concentration is proportional, so the pepsin concentration can be detected.
  • the bromophenol blue dye in the pepsin measuring part 35 shows different colors to the pepsin concentration of different concentrations, and the concentration can be quantitatively detected through the color change.
  • pepsin can only exist in an acidic environment, and neutral or alkaline environments will lose its activity and denaturation. Therefore, pepsin only exists in the stomach. Based on this, the pepsin measuring unit 35 can only be used to measure the amount of gas in the stomach. The concentration of pepsin cannot be used in other organs (because pepsin in other organs is inactivated).
  • the pepsin in the stomach is combined with the bromophenol blue dye, so that the molar absorption coefficient and the light scattering signal change, and then the color is displayed, and the color and the concentration of pepsin are in a certain proportional relationship, so as to achieve the corresponding Protein detection.
  • the pepsin measuring component 35 has different color changes in the range of low concentration to high concentration in the detection environment of acidic environment, and has a certain continuous detection function; but it has a certain continuous detection function when the solution environment changes (for example, from the stomach to the After the duodenum), it does not have continuous detection characteristics.
  • the medical detection device in the embodiment of the present application integrates the pepsin measurement component 35.
  • the integration process can be simplified and the cost can be reduced.
  • the medical detection device can Realize non-invasive detection, and the measurement accuracy is high.
  • the measurement component 3 when the medical detection device is used to measure the concentration of trypsin in the digestive tract, the measurement component 3 includes at least a trypsin measurement component 36, wherein the body portion 31 of the trypsin measurement component 36 can be It includes polyion gel and bromocresol purple dye, wherein when the concentration of trypsin in the solution (such as the digestive tract) is different, the bromocresol purple dye has different colors.
  • the trypsin measuring component 36 including polyion gel and bromocresol purple dye when used, since the polyionic liquid gel and bromocresol purple dye ions have a strong ionic interaction, it can be Makes the bromocresol purple dye ions remain in the gel without leakage. And bromocresol purple dye is a kind of biological stain.
  • the bromocresol purple dye is non-covalently bonded to trypsin, and the hydrophobic core of trypsin and the non-covalent bond of bromocresol purple dye Polar groups are combined, and the volume of the combined aggregate is greater than the volume of the bromocresol violet dye itself, so that the combined molar absorption coefficient and light scattering signal change, and then display different colors, and its signal intensity and unit
  • the number of particles in the volume that is, the trypsin concentration is proportional, so the trypsin concentration can be detected.
  • the bromocresol purple dye in the trypsin measuring component 36 shows different colors for different concentrations of trypsin, and the concentration can be quantitatively detected through color changes.
  • trypsin can only exist in a weakly alkaline environment, the acidic environment will lose its activity and denaturation. Trypsin exists in the pancreas, and the trypsin in the pancreas can flow into the duodenum with pancreatic juice. Based on this, the trypsin The measuring part 36 can only be used to measure the concentration of trypsin in the pancreas and duodenum, and cannot be used in other organs (because trypsin in other organs is inactivated).
  • trypsin is combined with bromocresol purple dye to change the molar absorption coefficient and the light scattering signal to show the color, and the color is proportional to the concentration of trypsin, so as to achieve the corresponding protein Detection.
  • the trypsin measurement unit 36 has different color development changes in the range of low to high concentration in the detection environment of a weak alkaline environment, and has a certain continuous detection function; but it has a certain continuous detection function when the solution environment changes (for example, by ten After the diodenum to the jejunum), it does not have continuous detection characteristics.
  • the medical detection device in the embodiment of the present application integrates the trypsin measurement component 36.
  • the integration process can be simplified and the cost can be reduced.
  • the medical detection device can Realize non-invasive detection, and the measurement accuracy is high.
  • the medical detection equipment may include a plurality of measurement components 3, and the range of each measurement component 3 is not completely the same, and/or the resolution of each measurement component 3 is not completely the same, and the resolution of each measurement component 3 is not completely the same.
  • the combination of component 3 can satisfy the measurement of the concentration of a variety of parameters to be measured, and improve the accuracy and measurement range of the measurement.
  • the medical detection equipment may include a plurality of pH measurement components 33, and the range of each pH measurement component 33 is not completely the same, and/or the resolution of each pH measurement component 33 is not completely the same, and the multiple pH measurement components 33
  • the combination of can meet the measurement of multiple pH values, improve the accuracy and measurement range of the measurement, and can also avoid the failure of a single pH measurement component 33 to cause the inability to measure the pH information or the measurement result to be inaccurate.
  • the plurality of measurement components 3 may be the same type of measurement components 3, or may be different types of measurement components 3, that is, a combination of multiple types of measurement components 3.
  • the medical detection device includes a pH measurement component 33, an occult blood measurement component 34, a pepsin measurement component 35, and a trypsin measurement component 36 at the same time, so that the medical detection device can be used for measurement.
  • the pH value of the digestive tract, occult blood concentration, pepsin concentration and trypsin concentration is a pH measurement component 33, an occult blood measurement component 34, a pepsin measurement component 35, and a trypsin measurement component 36 at the same time, so that the medical detection device can be used for measurement.
  • each measuring part 3 mentioned above may be circular.
  • the medical detection device includes a pepsin measurement part 35 and a trypsin measurement part 36, so that the medical detection device can be used to measure the concentration of pepsin and trypsin.
  • each of the above-mentioned pepsin measuring part 35 and trypsin measuring part 36 may include one or more in order to improve the accuracy of the measurement.
  • the shape of each measuring part 3 mentioned above may be a rectangle.
  • the medical detection device includes a pH measurement component 33 and an occult blood measurement component 34, so that the medical detection device can measure the pH value and the occult blood concentration.
  • each of the above-mentioned pH measuring component 33 and occult blood measuring component 34 may include one or more in order to improve the accuracy of the measurement.
  • the shape of each measuring part 3 mentioned above may be circular.
  • the housing 1 in the medical detection device, at least part of the housing 1 is a transparent portion 11, which is made of a transparent material with biocompatibility, that is, passes through the transparent portion 11 11.
  • the environment outside the housing 1 can be observed from the inside of the housing 1.
  • the medical detection equipment also includes an imaging component 4.
  • the imaging component 4 is located in the inner cavity of the housing 1, and specifically includes a lens 41, an image sensor 42, and a lighting lamp 43.
  • the lens 41 can pass through the housing.
  • the transparent part 11 of the body 1 receives light from the environment outside the housing 1 (such as the digestive tract of the human body), the image sensor 42 is used to convert the light signal received by the lens 41 into an electrical signal, and the illuminating lamp 43 is used for lighting, which may be specifically The LED lamp, and the illuminating lamp 43 includes the LED structure 431, therefore, the image component 4 can take and observe pictures of the external environment of the housing 1 through the principle of optical imaging.
  • the medical detection device in the embodiment of the present application may be an endoscope.
  • the medical detection equipment further includes a data transmission component 2, which is located in the inner cavity of the housing 1, and specifically includes a data acquisition and processing module 21, an antenna 22, and a battery 23.
  • the battery 23 supplies power to the imaging components 4 and the components in the data transmission assembly 2, and the data acquisition and processing module 21 is electrically or signal connected to the imaging component 4, so as to be able to identify and process the information in the imaging component 4.
  • the antenna 22 Used to pass the obtained information to an external receiving device.
  • the medical detection equipment can be a capsule endoscope.
  • the circuit board of the capsule endoscope is first assembled and connected with the imaging component 4 and the data transmission component 2.
  • the components are mainly bonded by UV glue.
  • Form a capsule core with camera function and then put the capsule core into the shell 1, first put the capsule core into the lower shell 13, then install the upper shell 12, and clamp the LED structure 431 to the upper shell 12
  • the position of the LED structural member 431 inside the capsule is fixed, and the capsule core is fixed inside the housing 1 to complete the assembly of the capsule endoscope.
  • the medical detection equipment described above when the medical detection equipment described above is built into various parts of the human body, its measuring part 3 can display different colors according to different concentrations of the parameters to be measured, and the concentration of the parameters to be measured can be quantitatively detected by color changes.
  • the change can be judged by obtaining a picture of the measuring component 3 through the lens 41 of the imaging component 4, and the color information is sent to an external receiving device via the data transmission component 2 and can be displayed in real time, thereby facilitating detection.
  • the medical inspection equipment can also take and observe pictures of the external environment of the medical inspection equipment through the lens 41 of the imaging component 4, and the picture information can be sent to the external receiving equipment through the data transmission component 2 and can be displayed in real time, thereby judging the position of the part. Health status.
  • the medical testing equipment in the embodiment of the present application can observe the health of the digestive tract mucosa by setting the imaging component 4 and the data transmission component 2, and by setting the measuring component 3, it can measure the concentration of the parameter to be measured in the digestive tract, that is, the medical testing equipment
  • the endoscopic device and the measuring component 3 are integrated.
  • the process of integrating the two components can be simplified and the integration cost can be reduced.
  • the lens 41 is installed in the inner cavity of the housing 1, and the lens 41 has an effective imaging angle ⁇ 1, and the transparent portion 11 of the housing 1 can cover the space where the effective imaging angle ⁇ 1 is located. Therefore, The field of view of the lens 41 is not blocked.
  • the image sensor 42 has a display image angle ⁇ 2, and the transparent portion 11 of the housing 1 can also cover the space where the display image angle ⁇ 2 is located. Therefore, the imaging area of the image sensor 42 is not blocked. .
  • ⁇ 1> ⁇ 2 is satisfied. That is to say, although the lens 41 can take pictures in the range corresponding to ⁇ 1, and the corresponding range of ⁇ 1 has an effective imaging angle boundary D1, the image sensor 42 The range in which the picture can be displayed is a range corresponding to ⁇ 2, and the range corresponding to ⁇ 2 has a display image angle boundary D2.
  • the above-mentioned effective imaging angle ⁇ 1 may be 140°
  • the display image angle ⁇ 2 may be 135°.
  • the above-mentioned measuring component 3 is installed on the transparent portion 11 and is located in the space between the effective imaging angle ⁇ 1 and the displayed image angle ⁇ 2, that is, the measuring component 3 is located in the effective Between the imaging angle boundary D1 and the display image angle boundary D2, and between the effective imaging angle boundary D1 and the display image angle boundary D2, a plurality of measuring components 3 may be included, and the plurality of measuring components 3 may be of the same type or different types, In the embodiment shown in FIG. 10, there is a pH measuring part 33 and a pepsin measuring part 35 between the effective imaging angle boundary D1 and the displayed image angle boundary D2, and both of them may be arc-shaped structures.
  • the measurement component 3 cannot be observed in the observation area of the image sensor 42, but the measurement component 3 is located within the imaging range of the lens 41, so the lens 41 and the data transmission assembly 2 can read the color of the measurement component 3
  • the color information can be transmitted to the external receiving device via the antenna 22, so that the color information can be displayed by the external receiving device, and the concentration value of the parameter to be measured can be obtained according to the color information. Since the measurement component 3 does not occupy the imaging area of the image sensor 42, a complete image of the mucosa of the digestive tract can be observed, and the image can be transmitted to the external receiving device via the antenna 22, and the image can be displayed on the external receiving device for Observe the health of the digestive tract.
  • the measuring component 3 is installed on the transparent portion 11 and is located in the space occupied by the display image angle ⁇ 2, that is, the measuring component 3 is located inside the display image angle boundary D2 and is close to the display
  • the image angle boundary D2 can prevent the measurement component 3 from occupying the middle position of the display image range and reduce the occlusion of the image by the measurement component 3.
  • the measurement component 3 is located in the imaging area of the image sensor 42, and the image sensor 42 transmits the color information of the measurement component 3 to the external receiving device, so that the user can observe the measurement component 3 displayed by color, and the color information can be It is transmitted to the external receiving device via the antenna 22, so that the concentration of the parameter to be measured is displayed on the external receiving device. Therefore, the medical detection device in this embodiment can collect the concentration of the parameter to be measured in the digestive tract while observing the mucosa of the digestive tract.
  • One or more measuring components 3 may be provided inside the display image angle boundary D2 of the medical detection equipment, and the multiple measuring components 3 may be of the same type or different types.
  • the display image angle boundary D2 An occult blood measuring part 34 and a trypsin measuring part 36 are provided, and both of them may have an arc structure and are close to the display image angle boundary D2.
  • the measuring component 3 is installed on the transparent portion 11 and is located in the space occupied by the display image angle ⁇ 2, that is, the measuring component 3 is located inside the display image angle boundary D2. 3, and the measuring component 3 can be specifically located in the middle of the space occupied by the display image angle ⁇ 2.
  • the measurement component 3 is located in the imaging area of the image sensor 42, and the image sensor 42 transmits the color information of the measurement component 3 to the external receiving device, so that the user can observe the measurement component 3 displayed by color, and the color information can be It is transmitted to the external receiving device via the antenna 22, so that the concentration of the parameter to be measured is displayed on the external receiving device. Therefore, the medical detection device in this embodiment can collect the concentration of the parameter to be measured in the digestive tract while observing the mucosa of the digestive tract. At the same time, when the measuring component 3 is located in the middle of the space occupied by the display image angle ⁇ 2, it is convenient for the user to observe the measuring component 3 and reduce the occlusion, thereby obtaining the concentration value of the parameter to be measured more accurately.
  • the medical detection equipment may be provided with one or more measuring components 3, and the plurality of measuring components 3 may be of the same type or different types.
  • the display image angle boundary D2 and the effective imaging angle boundary D1 are between A plurality of pepsin measuring parts 35 and trypsin measuring parts 36 are provided, and each of the pepsin measuring parts 35 and trypsin measuring parts 36 is located in the corner of the field of view, the pH measuring part 33 is arranged in the display image angle boundary D2, and The pH measuring part 33 is located in the middle of the space occupied by the display image angle ⁇ 2. All of the above-mentioned measuring components 3 may have a circular structure.
  • the medical detection equipment may further include an infrared switch 5, which can function to turn on the measurement component 3, so that the measurement component 3 of the medical detection equipment can start working.
  • the image angle boundary D2 and the effective imaging angle boundary D1 of the camera 41 of the image component 4 may both be circular, and they are concentric.
  • the effective imaging angle boundary D1 of the camera 41 of the image component 4 may be a square, and the image angle boundary D2 may be a circle. At this time, when the measurement component 3 is located at the image angle boundary D2 and When the effective imaging angle boundary D1 is between, it may be located at the four corners of the effective imaging angle boundary D1.
  • the arrangement of the plurality of measuring components 3 on the outer wall of the housing 1 is a partition arrangement or an alternate arrangement.
  • the partition arrangement is to divide the outer wall of the housing 1 into several areas, and each area is used to set one or more measuring components 3 of the same type.
  • the transparent part 11 is divided into two left and right sub-parts.
  • Each sub-part can be provided with one or more measuring parts 3 of the same type; for example, Figure 11 divides the transparent part 11 into two left and right sub-parts.
  • a trypsin measuring part 36 is placed in the left sub-part
  • an occult blood measuring part 34 is placed in the right sub-part.
  • the partition arrangement is to divide the outer wall of the housing 1 into several areas, each area is used to set a plurality of different types of measurement components 3, and each type of measurement component 3 can be one or more.
  • the transparent part 11 is divided into four sub-parts in a clockwise direction with 900 as the division interval, and each sub-part can be provided with multiple different types of measurement components 3; for example, Figure 12 presses the transparent part 11 In the clockwise direction, using infrared switch 5 as the benchmark, the average is divided into four sub-parts [0,900], [900,1800], [1800,2700], and [2700,3600], and each sub-part is placed with a pancreas A protease measuring part 36 and a pepsin measuring part 35.
  • This alternate arrangement can obtain a more complete detection result to the greatest extent and optimize the detection when the solution (for example, the liquid in the gastrointestinal tract) is small and only part of the shell 1 is immersed in the solution.
  • the imaging component 4 includes a lens 41 for taking pictures of the digestive tract and obtaining color information of the measuring component 3.
  • the lens 41 can acquire the imaging image of the measuring component 3.
  • the imaging image of the measuring component 3 and the picture of the digestive tract are transmitted to an external receiving device via the data transmission component 2, and the external receiving device can be based on the measurement component
  • the imaging image of 3 recognizes the concentration of the corresponding parameter to be detected and displays it.
  • the medical detection equipment may also include two imaging components 4.
  • the housing 1 includes a first end and a second end (the upper housing 12 and the lower Shell 13), and both the first end and the second end can be provided with a transparent portion 11.
  • two imaging components 4 are respectively provided corresponding to the two transparent portions 11, wherein the medical detection device can be a double-lens capsule Endoscope.
  • the above-mentioned measuring components 3 may be all installed on the outer wall of the first end, or may be all installed on the outer wall of the second end.
  • an imaging component 4 of the medical detection equipment is used to measure the concentration of the parameter to be measured.
  • the other is used to observe and take pictures.
  • the outer wall of the first end of the housing 1 is equipped with a first measuring component
  • the outer wall of the second end is equipped with a second measuring component.
  • the first end may be provided with one or more first measuring parts.
  • one or more second measuring components can be arranged at the second end, and the types of the first measuring component and the second measuring component can be the same or different, and the range can be the same or different.
  • the medical detection equipment can meet the detection of different concentration ranges at the same time.
  • the first end and the second end of the housing 1 are both provided with a camera 41, and the camera 41 is located at the transparent portion 11 of the first end and the second end.
  • the first end may be provided with a pH measurement component 33 and a pepsin measurement component 35
  • the second end may be provided with an occult blood measurement component 34 and a trypsin measurement component 36.
  • the first end of the medical detection device In addition to taking pictures of the digestive tract, it can also measure the pH value and pepsin concentration in the digestive tract.
  • the second end of the medical testing device can be used to take pictures of the digestive tract as well as the concentration of pepsin in the digestive tract. The occult blood concentration and trypsin concentration.
  • the above-mentioned medical detection equipment may be a capsule endoscope, and of course, it may also be other medical detection equipment, such as other image measurement equipment such as electronic endoscopes.
  • the above-mentioned medical detection equipment when the above-mentioned medical detection equipment is a capsule endoscope device, it includes at least one measuring component 3 attached to the surface of the transparent part 11 of the capsule housing 1 and the capsule endoscope.
  • the measurement component 3 can be a ring structure, the inner and outer diameters can be 5mm and 6mm, and the thickness can be 40um. Of course, the size and thickness can also be other values, and the body portion 31 of the measurement component 3 can pass medical UV
  • the glue (adhesive material 32) is pasted on the outer surface of the transparent part 11.
  • the measuring part 3 can be between the effective imaging angle ⁇ 1 and the displayed image angle ⁇ 2, without affecting the image display of the normal user interface, and the measuring part 3 can be observed through an external receiving device. Measurement results.
  • the capsule endoscope device includes a capsule endoscope and a measuring component 3 adhered to the surface of the transparent portion 11 of the capsule housing 1.
  • the measuring component 3 can be strip-shaped, the length and width dimensions can be 6 mm and 2 mm, respectively, and the thickness can be 50 um. Of course, the dimensions and thickness can also be other values.
  • the body portion 31 of the measuring component 3 can be pasted on the surface of the transparent portion 11 of the housing 1 by a medical adhesive (glue material 32), and the measuring component 3 can be within the effective imaging angle ⁇ 1.
  • the embodiment of the present application also provides a measurement component 3 of a medical detection component.
  • the measurement component 3 includes a polyion gel and a dye.
  • the dye is a substance that can have different colors according to the concentration of the parameter to be measured.
  • the ion gel is a solid substance formed by polymer cross-linking polymerization, and the dye is filled in the polyion gel. Due to the strong ionic interaction between the polyion gel and the dye ions, the dye ions can be retained In polyion gel. When working, the ions of the substance to be measured in the environmental solution can pass through the polyion gel and change color after being combined with the dye, so as to display the concentration of the parameter to be measured in the environmental solution.

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Abstract

提供了一种医用检测设备及医用检测设备的测量部件。医用检测设备包括：壳体（1）；测量部件（3），安装于壳体（1）的外壁，用于测量壳体（1）外部环境中的待测量参数的浓度。该医用检测设备通过设置测量部件（3），实现对消化道内各参数的检测，提高了检测结果的准确性。

Description

一种医用检测设备及医用检测设备的测量部件 技术领域
本申请涉及医疗器械技术领域，尤其涉及一种医用检测设备及医用检测设备的测量部件。
背景技术
随着生活节奏的加快，人们生活压力也逐渐加大，再加上饮食结构的变化，导致消化道疾病已经成为严重影响人们生活质量的疾病种类。消化道疾病的诊断及治疗建立在对消化道的生理参数及粘膜状态的准确检查基础之上。
目前，通常采用内窥镜装置对消化道黏膜进行直观观察，但是由于技术集成的限制，市面上的内窥镜仅能够对消化道黏膜进行图像观察，而无法获取消化道内的其他有用信息。因此，现有的内窥镜装置功能单一，无法完成对消化道的准确检测。
申请内容
本申请提供了一种医用检测设备及医用检测设备的测量部件，该医用检测设备的检测准确性较高。
本申请实施例第一方面提供一种医用检测设备，所述医用检测设备包括：
壳体；
测量部件，安装于所述壳体的外壁，用于测量所述壳体外部环境中待测量参数的浓度。
在一种可能的设计中，所述测量部件包括聚离子凝胶和染料，所述染料填充于所述聚离子凝胶中；
待测量参数的浓度不同时，所述染料能够变色。
在一种可能的设计中，所述测量部件包括pH测量部件、潜血测量部件、胃蛋白酶测量部件、胰蛋白酶测量部件中的一种或多种。
在一种可能的设计中，所述pH测量部件的所述染料为pH敏感染料，在pH值不同的环境中，所述pH敏感染料能够变色。
在一种可能的设计中，所述壳体外部环境中的氢离子能够通过所述聚离子凝胶进入所述pH测量部件中，所述pH测量部件中的氢离子能够通过所述聚离子凝胶进入所述壳体外部的环境；
所述pH敏感染料能够与氢离子结合或分离，以形成动态平衡。
在一种可能的设计中，所述潜血测量部件的所述染料包括亚甲蓝染料，在潜血浓度不同的环境中，所述亚甲蓝染料能够变色。
在一种可能的设计中，所述壳体外部环境中的血红蛋白能够与所述潜血测量部件中的所述聚离子凝胶及所述亚甲蓝染料结合并反应；
在血红蛋白的作用下，通过氧化还原反应，所述亚甲蓝染料能够显示颜色，且所述血红蛋白的浓度不同时，所述亚甲蓝染料所显示的颜色不同。
在一种可能的设计中，所述胃蛋白酶测量部件的所述染料包括溴酚蓝染料，在胃蛋白酶浓度不同的环境，所述溴酚蓝染料能够变色。
在一种可能的设计中，所述壳体外部环境中的胃蛋白酶能够与所述胃蛋白酶测量部件中聚离子凝胶及溴酚蓝染料结合；
结合后的溴酚蓝染料其光散射信号发生变化，显示出不同颜色，且胃蛋白酶的浓度不同时，所述溴酚蓝染料的颜色不同。
在一种可能的设计中，所述胰蛋白酶测量部件的所述染料包括溴甲酚紫染料，在胰蛋白酶浓度不同的环境，所述溴甲酚紫染料能够变色。
在一种可能的设计中，所述壳体外部环境中的胰蛋白酶能够与所述胰蛋白酶测量部件中的聚离子凝胶及溴甲酚紫染料结合；
结合后的溴甲酚紫染料体积发生改变，其光散射信号发生变化，显现出 不同颜色，且胰蛋白酶的浓度不同时，所述溴甲酚紫染料的颜色不同。在一种可能的设计中，所述测量部件在壳体的外壁的排列方式为分区排列方式或交替排列方式。
在一种可能的设计中，所述医用检测设备包括多个所述测量部件；
各所述测量部件的量程不完全相同，和/或，各所述测量部件的分辨率不完全相同。
在一种可能的设计中，所述壳体包括透明部；
所述医用检测设备还包括影像部件，所述影像部件位于所述壳体的内腔，且所述影像部件能够通过所述透明部观察所述壳体外部的环境。
在一种可能的设计中，所述壳体沿轴向包括相对设置的第一端部和第二端部，所述第一端部和所述第二端部均包括所述透明部；
所述医用检测设备包括两个所述影像部件，两个所述影像部件分别与两个所述透明部对应设置；
所述测量部件安装于所述第一端部或所述第二端部的外壁；或者，
所述医用检测设备至少包括第一测量部件和第二测量部件，且所述第一测量部件与所述第二测量部件的量程不同，所述第一测量部件与所述第二测量部件中，一者安装于所述第一端部的外壁，另一者安装于所述第二端部的外壁。
在一种可能的设计中，所述医用检测设备还包括数据传输组件；
所述影像部件包括镜头和图像传感器，所述镜头与所述图像传感器通过机械结构和/或胶水连接；
所述图像传感器与所述数据传输组件电连接或信号连接，所述镜头与所述数据传输组件通过机械结构和/或胶水连接。
在一种可能的设计中，所述镜头安装于所述壳体的内腔，且所述镜头具有有效成像角度α1，所述透明部能够覆盖所述有效成像角度α1所在的空间；
所述图像传感器具有显示图像角度α2，所述透明部能够覆盖所述显示图 像角度α2所在的空间，且α1＞α2；
所述测量部件安装于所述壳体的外壁，且位于所述有效成像角度α1与所述显示图像角度α2之间的空间；
所述数据传输组件能够读取所述测量部件的数据。
在一种可能的设计中，所述镜头安装于所述壳体的内腔，且所述镜头具有有效成像角度α1，所述透明部能够覆盖所述有效成像角度α1所在的空间；
所述图像传感器具有显示图像角度α2，所述透明部能够覆盖所述显示图像角度α2所在的空间，且α1＞α2；
所述测量部件安装于所述壳体的外壁，且位于所述显示图像角度α2所占据的空间；
所述图像传感器能够识别所述测量部件的数据。
在一种可能的设计中，所述测量部件位于所述显示图像角度α2所占据的空间的中部。
在一种可能的设计中，所述测量部件通过透明胶材粘贴于所述壳体的外壁。
在一种可能的设计中，所述测量部件还通过封边胶与所述壳体的外壁粘连，所述封边胶包覆所述测量部件的外边缘。
在一种可能的设计中，所述壳体为胶囊式结构；
所述医用检测设备为胶囊式内窥镜。
本申请实施例第二方面提供一种医用检测设备的测量部件，所述测量部件包括聚离子凝胶和染料，所述染料填充于所述聚离子凝胶中；
待测量参数的浓度不同时，所述染料能够变色。
因此，本申请实施例中的医用检测设备通过设置测量部件，能够实现对消化道内各参数(包括pH值、潜血浓度、胃蛋白酶浓度以及胰蛋白酶浓度等)的检测，从而能够提高该医用检测设备对消化道的检测结果的准确性，且使得医用检测设备具有多种功能，提高其实用性。
应当理解的是，以上的一般描述和后文的细节描述仅是示例性的，并不能限制本申请。
附图说明
为了更清楚地说明本申请实施例的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其它的附图。
图1为本申请所提供医用检测设备在第一种具体实施例中的结构示意图；
图2为图1的爆炸图；
图3为图1的局部剖视图；
图4为图1中测量部件的结构示意图；
图5为图4中的测量部件与壳体连接的结构示意图；
图6为本申请所提供医用检测设备在第二种具体实施例中的结构示意图；
图7为本申请所提供医用检测设备在第三种具体实施例中的结构示意图；
图8为本申请所提供医用检测设备在第四种具体实施例中的结构示意图；
图9为本申请所提供医用检测设备在第五种具体实施例中的结构示意图；
图10为本申请所提供医用检测设备在第六种具体实施例中的俯视图；
图11为本申请所提供医用检测设备在第七种具体实施例中的俯视图；
图12为本申请所提供医用检测设备在第八种具体实施例中的俯视图；
图13为本申请所提供医用检测设备在第九种具体实施例中的俯视图。
附图标记：
1-壳体；
11-透明部；
12-上壳；
13-下壳；
14-封边胶；
2-数据传输组件；
21-数据采集处理模块；
22-天线；
23-电池；
3-测量部件；
31-本体部；
32-胶材；
33-pH测量部件；
34-潜血测量部件；
35-胃蛋白酶测量部件；
36-胰蛋白酶测量部件；
4-影像部件；
41-镜头；
411-镜头基座；
42-图像传感器；
43-照明灯；
431-LED结构件；
5-红外开关；
D1-有效成像角度边界；
D2-显示图像角度边界。
具体实施方式
为了更好的理解本申请的技术方案，下面结合附图对本申请实施例进行 详细描述。
应当明确，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其它实施例，都属于本申请保护的范围。
在本申请实施例中使用的术语是仅仅出于描述特定实施例的目的，而非旨在限制本申请。在本申请实施例和所附权利要求书中所使用的单数形式的“一种”、“所述”和“该”也旨在包括多数形式，除非上下文清楚地表示其他含义。
应当理解，本文中使用的术语“和/或”仅仅是一种描述关联对象的关联关系，表示可以存在三种关系，例如，A和/或B，可以表示：单独存在A，同时存在A和B，单独存在B这三种情况。另外，本文中字符“/”，一般表示前后关联对象是一种“或”的关系。
需要注意的是，本申请实施例所描述的“上”、“下”、“左”、“右”等方位词是以附图所示的角度来进行描述的，不应理解为对本申请实施例的限定。此外，在上下文中，还需要理解的是，当提到一个元件连接在另一个元件“上”或者“下”时，其不仅能够直接连接在另一个元件“上”或者“下”，也可以通过中间元件间接连接在另一个元件“上”或者“下”。
本申请实施例提供一种医用检测设备，如图1和图2所示，该医疗检测设备包括壳体1和测量部件3，其中，该壳体1还可包括上壳12和下壳13，且该上壳12和下壳13固定连接，并围成该壳体1的内腔；测量部件3安装于壳体1的外壁，用于测量壳体1的外部环境的参数。其中，当该医疗检测设备用于消化道检测时，可以用于检测消化道的pH值、潜血浓度、胃蛋白酶浓度以及胰蛋白酶浓度等参数。
因此，本申请实施例中的医用检测设备通过设置测量部件3，能够实现对消化道内各参数(包括pH值、潜血浓度、胃蛋白酶浓度以及胰蛋白酶浓度等)的检测，从而能够提高该医用检测设备对消化道的检测结果的准确性。
具体地，本申请实施例中的测量部件3可以包括pH测量部件33、潜血测量部件34、胃蛋白酶测量部件35、胰蛋白酶测量部件36中的一种或多种，其中，pH测量部件33能够用于测量壳体1的外部环境(例如消化道)的pH，潜血测量部件34能够用于测量壳体1的外部环境(例如消化道)中是否存在潜血以及潜血的浓度，胃蛋白酶测量部件35用于测量壳体1的外部环境(例如消化道)中胃蛋白酶的浓度，胰蛋白酶测量部件36用于测量壳体1的外部环境(例如消化道)中胰蛋白酶的浓度。
因此，本实施例中，通过上述各种测量部件3，能够实现对消化道各参数的测量，从而提高医用检测设备的检测结果的精度。
其中，需要说明的是，本申请实施例中的医用检测设备并非必须包括上述四种测量部件3，可以仅包括其中的一种或任意组合。
具体地，如图4所示，该测量部件3可以包括本体部31和胶材32，其中，胶材32为透明胶材，且具有生物相容性，从而通过该胶材32能够将测量部件3的本体部31粘贴于医疗检测设备的壳体1。其中，该胶材32可为透明背胶，且粘贴于壳体1的透明部11。所述透明背胶可以为，但不限于，医用级UV胶，医用瞬干胶，或医疗背胶。
更具体地，如图5所示，该测量部件3的本体部31与壳体1的外壁之间还通过封边胶14连接，其中，该封边胶14设置于本体部31的外边缘，从而使得测量部件3与壳体1之间通过封边胶14粘连。其中，该封边胶14可以为，但不限于，医用级UV胶，医用瞬干胶，或医疗背胶。
本实施例中，该测量部件3的外边缘与壳体1之间通过封边胶14连接时，能够进一步提高测量部件3与壳体1之间的连接可靠性，并降低使用和安装过程中测量部件3从壳体1脱落的风险。
具体地，该测量部件3可以包括聚离子凝胶和染料，该染料能够变色。且该测量部件3可以为薄膜结构，其形状可以为圆形、方形、多边形等任意形状，本申请对测量部件3的具体形状不做限定。
在一种可能的设计中，该测量部件3的本体部31包括聚离子凝胶和染料，其中，染料能够变色，聚离子凝胶为通过聚合物交联聚合形成的固态物质，且染料填充于该聚离子凝胶中，由于聚离子凝胶与染料离子之间具有较强的离子相互作用，从而能够使得染料离子保持在聚离子凝胶中。
其中，上述聚离子凝胶含有离子交换膜结构，离子交换膜为一种含有离子基团的、对溶液中的离子具有选择透过能力的高分子膜。同时，当该测量部件3位于溶液环境(例如人体的消化道)时，溶液中待测量物质的离子(例如氢离子)能够进入聚离子凝胶，并与聚离子凝胶中的染料结合，以使染料变色。另外，该测量部件3中，溶液中的待测量物质的离子(例如氢离子)与聚离子凝胶中待检测物质的离子(例如氢离子)浓度相同，当溶液中的待检测物质的离子(例如氢离子)浓度增大时，能够扩散进入聚离子凝胶内，从而增大与染料结合的待测量物质的离子(例如氢离子)浓度，对应一个待测量物质的浓度(例如氢离子的浓度，即溶液的pH值)；当溶液中待测量物质的离子(例如氢离子)浓度减小时，聚离子凝胶中的待测量物质的离子(例如氢离子)能够扩散进入溶液中，从而减小与染料结合的待测量物质的离子(例如氢离子)浓度，对应另一个待测量物质的浓度(例如氢离子的浓度，即溶液的pH值)。
因此，本实施例中，该测量部件3中的染料能够与待测量物质的离子(例如氢离子)结合或分离，以形成动态平衡，并能够实现待测量物质浓度的连续测量。
基于此，本实施例中，包括聚离子凝胶和染料的测量部件3能够方便地与医用检测设备(例如胶囊内窥镜)集成(例如粘贴)，且集成后与医用检测设备的硬件相容，无需进行二次封装，仅需要修改相关软件即可实现内窥镜检查的同时进行酸碱度测量，以便提高检测的准确性。同时，通过增设聚离子凝胶，且溶液中的待检测物质的离子能够透过该聚离子凝胶，与染料结合，与染料结合的待检测物质的离子也能够透过该聚离子凝胶，从而使得该测量 部件3能够与待检测物质的离子形成动态平衡，以实现待检测物质的浓度的连续测量。另外，该测量部件3还有助于实现产业化，降低成本。
在一种具体实施例中，当该医用检测设备用于测量消化道的pH值时，该测量部件3至少包括pH测量部件33，其中，该pH测量部件33的本体部31可以包括聚离子凝胶和pH敏感染料，其中，当溶液中氢离子的浓度不同时，该pH敏感染料具有不同的颜色。
在医疗器械领域，检测人体内部的酸碱度时，现有技术中主要通过以下两种方式实现，一种是pH电极，通过将对氢离子敏感的材料制成电极，利用电化学原理，可以直接测试出待测环境的pH值，精度较高，例如锑电极。另一种方案是通过颜色变化来判断待测环境的酸碱度，精度较低，例如传统的pH试纸，以及pH指示剂等。
通过电化学方法进行pH测量时，传感器较为复杂，需要将参比电极与测试电极封装在一起，同时需保证其与测试环境之间具有离子通道。对于常规使用场景而言，玻璃电极、锑电极以及氢离子敏感场效应晶体管(H+SFET)都能满足应用需求。但是，对于人体消化道的酸碱度测量来说，将上述pH电极集成到胶囊内窥镜上面难度极大，不易实现。此外，若采用锑电极作为pH电极，还存在潜在的生物毒性。
通过颜色变化测量酸碱度的方法由来已久，但是该方法无法连续测量不同的酸碱度环境，更无法集成到胶囊内窥镜装置上进行连续pH测量。
基于上述原因，在医疗设备领域，目前没有能够将内窥镜装置与pH测量传感器集成的工艺，或者，以目前的工艺，内窥镜装置与pH测量传感器集成后形成的设备可靠性较低，集成的工艺成本高。
而本实施例中，本申请中的医疗检测设备能够获取消化道的酸碱度信息，即该医疗检测设备集成了pH测量部件33，同时，通过改变pH测量部件33的结构，能够简化集成的工艺，并降低集成成本。且包括聚离子凝胶和pH敏感染料的pH测量部件33无需使用电化学电极，能够方便地与医用检测设备(例如 胶囊内窥镜)集成(例如粘贴)，且集成后与医用检测设备的硬件相容，无需进行二次封装，仅需要修改相关软件即可实现内窥镜检查的同时进行酸碱度测量，以便提高检测的准确性。同时，通过增设聚离子凝胶，且溶液中的氢离子能够透过该聚离子凝胶，与pH敏感染料结合，与pH敏感染料结合的氢离子也能够透过该聚离子凝胶，从而使得该pH测量部件33能够与氢离子形成动态平衡，以实现酸碱度的连续测量。且该pH测量部件33除了能够测量胃部的酸碱度外，还能够测量口腔、肠道等器官的酸碱度，且根据各器官酸碱度的不同，能够显示不同的颜色。另外，该pH测量部件3还有助于实现产业化，降低成本。
具体地，通过改变pH测量部件33中的pH敏感染料的量或种类，能够改变该pH测量部件33的量程和精度。例如，一种pH测量部件33能够满足对1、5、7、8酸碱度的测量，另一种pH测量部件33能够满足对2、3、4、6酸碱度的测量，因此，当该医疗测量部件包括上述两种pH测量部件33时，能够满足1～8范围内酸碱度的测量，且能够满足0.5～1pH值的分辨率。其中，上述两种pH测量部件33的区别在于二者的敏感染料种类不同，二者的聚离子凝胶可相同。
在另一种具体实施例中，当该医用检测设备用于测量消化道是否存在潜血以及潜血的浓度时，该测量部件3至少包括潜血测量部件34，其中，该潜血测量部件34的本体部31可以包括聚离子凝胶和亚甲蓝染料，其中，当溶液中血红蛋白的浓度不同时，该亚甲蓝染料具有不同的颜色。
在医疗设备领域，消化道潜血检测有两种主流的方案。第一种方案是隐血珠方法，其基本原理是吞服带有细线的胶囊状物，胶囊状物在尾部吸收胃液后通过细线拉出，然后向沾有胃液的胶囊状物上滴加显色剂，观察颜色变化以判断是否有隐血产生。第二种方案是通过潜血试纸检测粪便中的出血情况来检测消化道的潜血状况。
方案一仅适用于上消化道的潜血检测，且属于有创检测，检测过程会造成呕吐等不适反应。方案二仅适用于下消化道的潜血检测，尤其是结直肠的 检测，且易受痔疮等影响导致检测的假阳性现象。
本实施例中，包括聚离子凝胶和亚甲蓝染料的潜血测量部件34使用时，由于聚离子凝胶与亚甲蓝染料离子之间具有较强的离子相互作用，可使得亚甲蓝染料离子保持在聚离子凝胶中而不外泄，且亚甲蓝染料是一种生物染色剂，对血红蛋白具有氧化作用，反应过程中，亚甲蓝染料被血红蛋白还原后由蓝色转变为无色，且根据血红蛋白浓度的不同，蓝色的深浅不同，可以通过颜色变化对潜血情况进行定量检测。
本实施例中，亚甲蓝染料是一种无毒性的染料，它的氧化型呈蓝色，还原型无色。高浓度血红蛋白的环境下，由于细胞的新陈代谢作用，细胞内具有较强的还原能力，葡萄糖-6-磷酸脱氢酶的作用下，能使亚甲蓝染料由蓝色的氧化型变为无色或淡黄色的还原型，而低浓度的血红蛋白环境下，该环境中的细胞无还原能力或还原能力极弱，此时，该亚甲蓝染料呈蓝色或淡蓝色。因此，当亚甲蓝染料呈现蓝色或淡蓝色时，表示环境(例如消化道)中的血红蛋白为低浓度，当亚甲蓝染料呈无色或淡黄色时，表示环境(例如消化道)中的血红蛋白为高浓度。
另外，本实施例中的潜血测量部件34能实现连续测量，且能够测量不同器官的潜血浓度，例如，可以测量胃、肠道等器官的潜血。
因此，本申请实施例中的医疗检测设备集成了潜血测量部件34，同时，通过改变潜血测量部件34的结构，能够简化集成工艺，并降低成本，更重要的是，该医疗检测设备能够实现无创检测，且测量精度较高。
在又一种具体实施例中，当该医用检测设备用于测量消化道的胃蛋白酶浓度时，该测量部件3至少包括胃蛋白酶测量部件35，其中，该胃蛋白酶测量部件35的本体部31可以包括聚离子凝胶和溴酚蓝染料，其中，当溶液(例如消化道)中胃蛋白酶浓度的浓度不同时，该溴酚蓝染料具有不同的颜色。
人体胃液中的胃蛋白酶已成为胃炎、胃癌类疾病的生物学标志，当肠上 皮化生、不典型增生和胃癌时，胃蛋白酶分泌会减少；当感染幽门螺旋杆菌或有胃溃疡、十二指肠溃疡等疾病，胃蛋白酶值升高。目前大量统计分析表明，血清胃蛋白酶原含量变化与胃部疾病有关，认为血清胃蛋白酶原的检测在胃癌早期诊断中具有重要作用。
目前，现有技术主要通过三种方式检测胃蛋白酶的含量，第一种是血清采集体外检测，该方法通过采集受检者的血清进行分析，但这种方法为体内采集样本体外进行检测，以分析胃蛋白酶的具体含量，因此，所测胃蛋白酶为单次检测，对于实时监控胃液中胃蛋白含量具有局限性；另外，胃蛋白酶只在酸性环境中发挥作用，当pH＞6时即失去活性，在体外环境下容易受到环境影响造成测试结果不准确。第二种是依靠胃镜来确诊，但胃镜检查有一定痛苦、费用高、受限于医生水平，患者接受度低。第三种是胃蛋白酶化学发光免疫检测试剂盒检测方法，采用胃蛋白酶化学发光免疫检测试剂盒，该试剂盒包括胃蛋白酶抗原校准品、样品收集液、样品稀释液、胃蛋白酶抗体包被的微孔板、胃蛋白酶抗体标记物、化学发光底物液、浓缩洗涤液。该试剂盒可以检测出胃液中、食管内容物、咽喉部分泌物中的胃蛋白酶含量，并且根据是否可以检出胃蛋白酶来判断是否存在胃食管反流，根据胃蛋白酶含量判断胃部病变治疗的效果及其病情变化。该方法虽然能够进行胃蛋白酶检测，但过程复杂、对操作人员及检测设备要求高、同时成本也不低。
而本申请实施例中，包括聚离子凝胶和溴酚蓝染料的胃蛋白酶测量部件35使用时，由于聚离子液体凝胶与溴酚蓝染料离子之间具有较强的离子相互作用，可使得溴酚蓝染料离子保持在凝胶中而不外泄。且溴酚蓝染料是一种生物染色剂，在不同的pH值条件下，该溴酚蓝染料与胃蛋白酶以非共价键结合，胃蛋白酶的疏水核与溴酚蓝染料的非极性基团结合，结合后的聚集体体积大于溴酚蓝染料自身的体积，使得结合后的摩尔吸光系数发生变化，光散射信号发生变化，进而显示出不同颜色，且其信号强度与单位体积内的粒子数目、也就是胃蛋白酶浓度成比例关系，因此可实现对胃蛋白酶浓度的检测。 检测过程中，胃蛋白酶测量部件35中的溴酚蓝染料对不同浓度的胃蛋白酶浓度显现出不同的颜色，可以通过颜色变化对浓度进行定量检测。
另外，由于胃蛋白酶只能存在于酸性环境，中性或碱性环境会失去活性变性，因此，胃蛋白酶仅存在于胃里，基于此，该胃蛋白酶测量部件35仅能够用于测量胃里的胃蛋白酶浓度，无法用于其他器官(因为其他器官内胃蛋白酶失活)。检测时，胃里的胃蛋白酶与溴酚蓝染料结合，使得摩尔吸光系数发生变化，光散射信号发生变化，进而显示出颜色，且颜色与胃蛋白酶的浓度呈一定的比例关系，从而实现对相应蛋白质的检测。该胃蛋白酶测量部件35在酸性环境的检测环境下，在低浓度到高浓度范围内，具有不同的显色变化，有一定的连续检测功能；但其在溶液环境发生变化时(例如由胃到十二指肠后)，不具有连续检测特性。
因此，本申请实施例中的医疗检测设备集成了胃蛋白酶测量部件35，同时，通过改变胃蛋白酶测量部件35的结构，能够简化集成工艺，并降低成本，更重要的是，该医疗检测设备能够实现无创检测，且测量精度较高。
在又一种具体实施例中，当该医用检测设备用于测量消化道的胰蛋白酶浓度时，该测量部件3至少包括胰蛋白酶测量部件36，其中，该胰蛋白酶测量部件36的本体部31可以包括聚离子凝胶和溴甲酚紫染料，其中，当溶液(例如消化道)中胰蛋白酶浓度的浓度不同时，该溴甲酚紫染料具有不同的颜色。
本申请实施例中，包括聚离子凝胶和溴甲酚紫染料的胰蛋白酶测量部件36使用时，由于聚离子液体凝胶与溴甲酚紫染料离子之间具有较强的离子相互作用，可使得溴甲酚紫染料离子保持在凝胶中而不外泄。且溴甲酚紫染料是一种生物染色剂，在不同的pH值条件下，该溴甲酚紫染料与胰蛋白酶以非共价键结合，胰蛋白酶的疏水核与溴甲酚紫染料的非极性基团结合，结合后的聚集体体积大于溴甲酚紫染料自身的体积，使得结合后的摩尔吸光系数发生变化，光散射信号发生变化，进而显示出不同颜色，且其信号强度与单位体积内的粒子数目、也就是胰蛋白酶浓度成比例关系，因此可实现对胰蛋白 酶浓度的检测。检测过程中，胰蛋白酶测量部件36中的溴甲酚紫染料对不同浓度的胰蛋白酶浓度显现出不同的颜色，可以通过颜色变化对浓度进行定量检测。
另外，由于胰蛋白酶只能存在于弱碱环境，酸性环境会失去活性变性，胰蛋白酶存在于胰腺里，且胰腺中的胰蛋白酶可随胰液流至十二指肠中，基于此，该胰蛋白酶测量部件36仅能够用于测量胰腺及十二指肠的胰蛋白酶浓度，无法用于其他器官(因为其他器官内胰蛋白酶失活)。检测时，胰蛋白酶与溴甲酚紫染料结合，使得摩尔吸光系数发生变化，光散射信号发生变化，进而显示出颜色，且颜色与胰蛋白酶的浓度呈一定的比例关系，从而实现对相应蛋白质的检测。该胰蛋白酶测量部件36在弱碱环境的检测环境下，在低浓度到高浓度范围内，具有不同的显色变化，有一定的连续检测功能；但其在溶液环境发生变化时(例如由十二指肠到空肠后)，不具有连续检测特性。
因此，本申请实施例中的医疗检测设备集成了胰蛋白酶测量部件36，同时，通过改变胰蛋白酶测量部件36的结构，能够简化集成工艺，并降低成本，更重要的是，该医疗检测设备能够实现无创检测，且测量精度较高。
在一种具体实施例中，该医用检测设备可包括多个测量部件3，且各测量部件3的量程不完全相同，和/或，各测量部件3的分辨率不完全相同，通过多个测量部件3的组合，能够满足多种待测量参数的浓度的测量，提高测量的准确性和测量范围。同时，包括多个测量部件3时，还能够避免单个测量部件3失效导致无法测量待测量参数或者测量结果不准确。例如，该医用检测设备可包括多个pH测量部件33，且各pH测量部件33的量程不完全相同，和/或，各pH测量部件33的分辨率不完全相同，通过多个pH测量部件33的组合，能够满足多种酸碱度的测量，提高测量的准确性和测量范围，还能够避免单个pH测量部件33失效导致无法测量酸碱度信息或者测量结果不准确。
另外，多个测量部件3可以为同种类型的测量部件3，也可以为不同类型的测量部件3，即可以为多种测量部件3的组合。例如，如图6所示的实施例中， 该医用检测设备同时包括pH测量部件33、潜血测量部件34、胃蛋白酶测量部件35和胰蛋白酶测量部件36，从而使得该医用检测设备能够用于测量消化道的pH值、潜血浓度、胃蛋白酶浓度和胰蛋白酶浓度。另外，上述pH测量部件33、潜血测量部件34、胃蛋白酶测量部件35和胰蛋白酶测量部件36均可以包括一个或多个，以便提高测量的准确性。上述各测量部件3的形状可以为圆形。
如图7所示的实施例中，该医用检测设备包括胃蛋白酶测量部件35和胰蛋白酶测量部件36，从而使得该医用检测设备能够用于测量胃蛋白酶浓度和胰蛋白酶浓度。另外，上述胃蛋白酶测量部件35和胰蛋白酶测量部件36均可以包括一个或多个，以便提高测量的准确性。上述各测量部件3的形状可以为矩形。
如图8所示的实施例中，该医用检测设备包括pH测量部件33和潜血测量部件34，从而使得该医用检测设备能够测量pH值和潜血浓度。另外，上述pH测量部件33和潜血测量部件34均可以包括一个或多个，以便提高测量的准确性。上述各测量部件3的形状可以为圆形。
以上各实施例中，如图1所示，该医用检测设备中，壳体1的至少部分为透明部11，该透明部11为具有生物相容性的透明材料制成，即通过该透明部11，能够从壳体1的内部观察壳体1外部的环境。
同时，该医疗检测设备还包括影像部件4，如图1～3所示，该影像部件4位于壳体1的内腔，具体包括镜头41、图像传感器42和照明灯43，镜头41能够通过壳体1的透明部11接收壳体1外部环境(例如人体的消化道)的光，图像传感器42用于将镜头41接收到的光信号转换为电信号，照明灯43用于照明，具体可为LED灯，且该照明灯43包括LED结构件431，因此，该影像部件4通过光学成像原理，能够拍摄并观察壳体1外部环境的图片。基于此，本申请实施例中的医用检测设备可以为内窥镜。
进一步地，如图2和图3所示，该医疗检测设备还包括数据传输组件2，该数据传输组件2位于壳体1的内腔，具体包括数据采集处理模块21、天线22和 电池23，其中，电池23为影像部件4和数据传输组件2中的各部件供电，数据采集处理模块21与影像部件4电连接或信号连接，从而能够识别并处理影像部件4中的信息，同时，天线22用于将获得的信息传递至外部接收设备。
具体地，该医疗检测设备可为胶囊内窥镜，加工时，首先将该胶囊内窥镜的电路板与影像部件4和数据传输组件2组装连接，各部件连接时，主要通过UV胶粘接，形成具有拍照功能的胶囊芯，然后将该胶囊芯装入壳体1内，首先将胶囊芯装入下壳13，然后装上上壳12，并将LED结构件431卡接于上壳12和下壳13之间，从而使得LED结构件431在胶囊内部的位置固定，进而将胶囊芯固定在壳体1内部，完成胶囊内窥镜的组装。
因此，以上所述的该医用检测设备内置于人体的各部位时，其测量部件3能够根据不同浓度的待测量参数显示不同的颜色，可以通过颜色变化对待测量参数的浓度进行定量检测，且颜色变化能够通过影像部件4的镜头41获取测量部件3的图片进行判断，颜色信息经数据传输组件2发送至外部接收设备并能够实时显示，从而有助于检测。同时，该医用检测设备还能够通过影像部件4的镜头41拍摄并观察医用检测设备外部环境的图片，且图片信息能够经数据传输组件2发送至外部接收设备并能够实时显示，从而判断该部位的健康状况。
本申请实施例中的医疗检测设备通过设置影像部件4和数据传输组件2能够对消化道黏膜健康状况进行观察，通过设置测量部件3，能够测量消化道内待测量参数的浓度，即该医疗检测设备集成了内窥镜装置和测量部件3，同时，通过改变测量部件3的结构和类型，能够简化上述两部件集成的工艺，并降低集成成本。
具体地，如图3所示，镜头41安装于壳体1的内腔，且镜头41具有有效成像角度α1，且上述壳体1的透明部11能够覆盖有效成像角度α1所在的空间，因此，镜头41的视野未被遮挡。同时，如图3所示，该图像传感器42具有显示图像角度α2，且上述壳体1的透明部11也能够覆盖该显示图像角度α2所在的 空间，因此，图像传感器42的成像区域未被遮挡。
同时，该镜头41与图像传感器42安装后，满足α1＞α2，也就是说，虽然镜头41能够拍摄到α1对应范围内的图片，且α1对应范围具有有效成像角度边界D1，但是，图像传感器42能够显示该图片的范围为α2对应的范围，α2对应的范围具有显示图像角度边界D2。例如，上述有效成像角度α1可为140°，显示图像角度α2可为135°。
基于此，在第一种具体实施例中，如图10所示，上述测量部件3安装于透明部11，且位于有效成像角度α1与显示图像角度α2之间的空间，即测量部件3位于有效成像角度边界D1与显示图像角度边界D2之间，且在该有效成像角度边界D1与显示图像角度边界D2之间可以包括多个测量部件3，多个测量部件3可以类型相同也可以类型不同，如图10所示的实施例中，该有效成像角度边界D1与显示图像角度边界D2之间具有pH测量部件33和胃蛋白酶测量部件35，且二者均可以为弧形结构。
此时，图像传感器42的观察区域内无法观察到该测量部件3的情况，但是，测量部件3位于镜头41的成像范围内，因此，镜头41和数据传输组件2能够读取测量部件3的颜色信息，并能够经天线22将颜色信息传递至外部接收设备，从而通过外部接收设备显示该颜色信息，并根据颜色信息得到待测量参数的浓度值。由于该测量部件3未占用图像传感器42的成像区域，因此，能够观测到消化道黏膜的完整的图像，且该图像能够经天线22传递至外部接收设备，并在外部接收设备显示该图像，以便观察消化道的健康状况。
在另一实施例中，如图11所示，该测量部件3安装于透明部11，且位于显示图像角度α2所占据的空间，即该测量部件3位于显示图像角度边界D2内部，并靠近显示图像角度边界D2，从而能够避免测量部件3占据显示图像范围的中部位置，降低测量部件3对图像的遮挡。此时，测量部件3位于图像传感器42的成像区域内，图像传感器42将测量部件3的颜色信息传递至外部接收设备，从而使得用户能够观察到通过颜色显示的测量部件3，且该颜色信息能够经天 线22传递至外部接收设备，从而在外部接收设备显示待测量参数的浓度。因此，本实施例中的医用检测设备能够在观察消化道黏膜的同时，采集消化道的待测量参数的浓度。
该医用检测设备的显示图像角度边界D2内部可以设置一个或多个测量部件3，且多个测量部件3可以类型相同或不同，如图11所示的实施例中，该显示图像角度边界D2内设置有潜血测量部件34和胰蛋白酶测量部件36，且二者均可以为弧形结构，并靠近显示图像角度边界D2。
在又一种具体实施例中，该医用检测设备中，该测量部件3安装于透明部11，且位于显示图像角度α2所占据的空间，即该测量部件3位于显示图像角度边界D2内部测量部件3，且该测量部件3具体可以位于显示图像角度α2所占据的空间的中部。
此时，测量部件3位于图像传感器42的成像区域内，图像传感器42将测量部件3的颜色信息传递至外部接收设备，从而使得用户能够观察到通过颜色显示的测量部件3，且该颜色信息能够经天线22传递至外部接收设备，从而在外部接收设备显示待测量参数的浓度。因此，本实施例中的医用检测设备能够在观察消化道黏膜的同时，采集消化道的待测量参数的浓度。同时，该测量部件3位于显示图像角度α2所占据的空间的中部时，能够便于用户观察该测量部件3，降低遮挡，从而更加准确地获取待测量参数的浓度值。
该医用检测设备可以设置一个或多个测量部件3，且多个测量部件3可以类型相同或不同，如图12所示的实施例中，该显示图像角度边界D2与有效成像角度边界D1之间设置有多个胃蛋白酶测量部件35和胰蛋白酶测量部件36，且各胃蛋白酶测量部件35和胰蛋白酶测量部件36均位于视野的角落，该显示图像角度边界D2内设置有pH测量部件33，且该pH测量部件33位于显示图像角度α2所占据的空间的中部。上述测量部件3均可以为圆形结构。
同时，如图12所示，该医用检测设备还可以包括红外开关5，该红外开关5能够起到开启测量部件3的作用，从而使得该医用检测设备的测量部件3能够 开始工作。
如图10～12所示的实施例中，该影像部件4的摄像头41的图像角度边界D2与有效成像角度边界D1均可以为圆形，且二者同心。在如图13所示的实施例中，该影像部件4的摄像头41的有效成像角度边界D1可以为方形，图像角度边界D2可以为圆形，此时，当测量部件3位于图像角度边界D2与有效成像角度边界D1之间时，可以位于有效成像角度边界D1的四个角落。
在一种具体实施例中，多个测量部件3在壳体1的外壁的排列方式为分区排列方式或交替排列方式。所述分区排列方式为将壳体1的外壁划分为若干个区域，每个区域用于设置同种类型的一个或多个测量部件3。例如以红外开关5为基准，将透明部11平均划分为左右两个子部分，每个子部分可设置同种类型的一个或多个测量部件3；例如图11将透明部11平均划分为左右两个子部分后，左子部分放置一个胰蛋白酶测量部件36，右子部分放置一个潜血测量部件34。所述分区排列方式为将壳体1的外壁划分为若干个区域，每个区域用于设置多个不同类型的测量部件3，每种类型的测量部件3可为一个或多个。例如以红外开关5为基准，将透明部11按顺时针方向以900为分割区间平均划分为四个子部分，每个子部分可设置多个不同类型的测量部件3；例如图12将透明部11按顺时针方向，以红外开关5为基准，平均划分为[0，900]、[900，1800]、[1800，2700]、以及[2700，3600]的四个子部分后，每个子部分放置一个胰蛋白酶测量部件36及一个胃蛋白酶测量部件35。该交替排列方式可以在溶液(例如胃肠道内液体)较少，只有部分壳体1浸入溶液中时，最大程度得获得较完善的检测结果，优化检测。
另一方面，该医用检测设备中，如图6～8所示的实施例，该影像部件4包括一个镜头41，该镜头41用于拍摄消化道的图片、获取测量部件3的颜色信息。在本实施例中，镜头41可获取测量部件3的成像图像，该测量部件3的成像图像与消化道的图片一起经由数据传输组件2传送至外部的接收设备，外部的接收设备可根据测量部件3的成像图像识别出对应的待检测参数的浓度并显示。
当然，如图9所示，该医用检测设备还可包括两个影像部件4，具体地，其壳体1沿轴向包括相对设置的第一端部和第二端部(上壳12与下壳13)，且该第一端部和第二端部均可设置透明部11，同时，两个影像部件4分别与两个透明部11对应设置，其中，该医用检测设备可为双镜头胶囊内窥镜。
具体地，上述测量部件3可以全部安装于第一端部的外壁，或者可以全部安装于第二端部的外壁，此时，该医用检测设备的一个影像部件4用于测量待测量参数的浓度，另一个用于观察并拍摄图片。
或者，该医用检测设备中，壳体1的第一端部的外壁安装有第一测量部件，第二端部的外壁安装有第二测量部件，该第一端部可以设置一个或多个第一测量部件，第二端部可以设置一个或多个第二测量部件，且该第一测量部件与第二测量部件的类型可以相同也可以不同，量程可以相同也可以不同，当量程不同时，该医用检测设备能够同时满足不同浓度范围的检测。
如图9所示的实施例中，该壳体1的第一端部和第二端部均设置有摄像头41，且该摄像头41位于第一端部和第二端部的透明部11，同时，该第一端部可以设置有pH测量部件33和胃蛋白酶测量部件35，第二端部可以设置有潜血测量部件34和胰蛋白酶测量部件36，此时，该医用检测设备的第一端部除能够用于拍摄消化道的图片外，还能够测量消化道中的pH值和胃蛋白酶的浓度，该医用检测设备的第二端部除能够用于拍摄消化道的图片外，还能够测量消化道中的潜血浓度和胰蛋白酶浓度。
需要说明的是，以上所述的医用检测设备可为胶囊式内窥镜，当然，还可为其他医用检测设备，例如电子内窥镜等其他影像测量设备。
在一种具体实施例中，当上述医用检测设备为胶囊式内窥镜装置时，包括胶囊式内窥镜与胶囊壳体1透明部11表面贴敷的至少一个测量部件3。其中，该测量部件3可以为环形结构，内外径尺寸可以分别为5mm和6mm，厚度可以为40um，当然，其尺寸和厚度还可以为其他数值，且该测量部件3的本体部31通过医用UV胶(胶材32)粘贴于透明部11外表面，测量部件3可以处于有效成 像角度α1与显示图像角度α2之间，不影响正常用户界面的图像显示，可通过外部接收设备观察测量部件3的测量结果。
在另一种具体实施例中，该胶囊式内窥镜装置包括胶囊式内窥镜与胶囊壳体1透明部11表面贴敷的测量部件3。其中，测量部件3可以为条状，长宽尺寸可以分别为6mm与2mm，厚度可以为50um，当然，其尺寸和厚度还可以为其他数值。该测量部件3的本体部31可以通过医用粘合剂(胶材32)粘贴于壳体1透明部11的表面，且该测量部件3可以处于有效成像角度α1内。
另外，本申请实施例还提供一种医用检测部件的测量部件3，该测量部件3包括聚离子凝胶和染料，其中，染料为能够根据待测量参数浓度的不同而具有不同颜色的物质，聚离子凝胶为通过聚合物交联聚合形成的固态物质，且染料填充于该聚离子凝胶中，由于聚离子凝胶与染料离子之间具有较强的离子相互作用，从而能够使得染料离子保持在聚离子凝胶中。工作时，环境溶液中的待测量物质的离子能够通过聚离子凝胶，并与染料结合后变色，以便显示环境溶液的待测量参数的浓度。
以上所述仅为本申请的较佳实施例而已，并不用以限制本申请，凡在本申请的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本申请保护的范围之内。

Claims (23)

  1. 一种医用检测设备，其特征在于，所述医用检测设备包括：
    壳体(1)；
    测量部件(3)，安装于所述壳体(1)的外壁，用于测量所述壳体(1)外部环境中待测量参数的浓度。
  2. 根据权利要求1所述的医用检测设备，其特征在于，所述测量部件(3)包括聚离子凝胶和染料，所述染料填充于所述聚离子凝胶中；
    待测量参数的浓度不同时，所述染料能够变色。
  3. 根据权利要求2所述的医用检测设备，其特征在于，所述测量部件(3)包括pH测量部件(33)、潜血测量部件(34)、胃蛋白酶测量部件(35)、胰蛋白酶测量部件(36)中的一种或多种。
  4. 根据权利要求3所述的医用检测设备，其特征在于，所述pH测量部件(33)的所述染料为pH敏感染料，在pH值不同的环境中，所述pH敏感染料能够变色。
  5. 根据权利要求4所述的医用检测设备，其特征在于，所述壳体(1)外部环境中的氢离子能够通过所述聚离子凝胶进入所述pH测量部件(33)中，所述pH测量部件(33)中的氢离子能够通过所述聚离子凝胶进入所述壳体(1)外部的环境；
    所述pH敏感染料能够与氢离子结合或分离，以形成动态平衡。
  6. 根据权利要求3所述的医用检测设备，其特征在于，所述潜血测量部件(34)的所述染料包括亚甲蓝染料，在潜血浓度不同的环境中，所述亚甲蓝染料能够变色。
  7. 根据权利要求6所述的医用检测设备，其特征在于，所述壳体(1)外部环境中的血红蛋白能够与所述潜血测量部件(34)中的所述聚离子凝胶及 所述亚甲蓝染料结合并反应；
    在血红蛋白的作用下，通过氧化还原反应，所述亚甲蓝染料能够显示颜色，且所述血红蛋白的浓度不同时，所述亚甲蓝染料所显示的颜色不同。
  8. 根据权利要求3所述的医用检测设备，其特征在于，所述胃蛋白酶测量部件(35)的所述染料包括溴酚蓝染料，在胃蛋白酶浓度不同的环境，所述溴酚蓝染料能够变色。
  9. 根据权利要求8所述的医用检测设备，其特征在于，所述壳体(1)外部环境中的胃蛋白酶能够与所述胃蛋白酶测量部件(35)中的所述聚离子凝胶及所述溴酚蓝染料结合；
    结合后的所述溴酚蓝染料的光散射信号发生变化，显现出不同的颜色，且胃蛋白酶的浓度不同时，所述溴酚蓝染料的颜色不同。
  10. 根据权利要求3所述的医用检测设备，其特征在于，所述胰蛋白酶测量部件(36)的所述染料包括溴甲酚紫染料，在胰蛋白酶浓度不同的环境，所述溴甲酚紫染料能够变色。
  11. 根据权利要求10所述的医用检测设备，其特征在于，所述壳体(1)外部环境中的胰蛋白酶能够与所述胰蛋白酶测量部件(36)中的所述聚离子凝胶及所述溴甲酚紫染料结合；
    结合后的所述溴甲酚紫染料体积发生改变，且其光散射信号发生变化，显现出不同的颜色，且胰蛋白酶的浓度不同时，所述溴甲酚紫染料的颜色不同。
  12. 根据权利要求3所述的医用检测设备，其特征在于，多个所述测量部件(3)在所述壳体(1)的外壁的排列方式为分区排列方式或交替排列方式。
  13. 根据权利要求1～12中任一项所述的医用检测设备，其特征在于，所述医用检测设备包括多个所述测量部件(3)；
    各所述测量部件(3)的量程不完全相同，和/或，各所述测量部件(3)的分辨率不完全相同。
  14. 根据权利要求1～12中任一项所述的医用检测设备，其特征在于，所述壳体(1)包括透明部(11)；
    所述医用检测设备还包括影像部件(4)，所述影像部件(4)位于所述壳体(1)的内腔，且所述影像部件(4)能够通过所述透明部(11)观察所述壳体(1)外部的环境。
  15. 根据权利要求14所述的医用检测设备，其特征在于，所述壳体(1)沿轴向包括相对设置的第一端部和第二端部，所述第一端部和所述第二端部均包括所述透明部(11)；
    所述医用检测设备包括两个所述影像部件(4)，两个所述影像部件(4)分别与两个所述透明部(11)对应设置；
    所述测量部件(3)安装于所述第一端部或所述第二端部的外壁；或者，
    所述医用检测设备至少包括第一测量部件(3)和第二测量部件(3)，且所述第一测量部件(3)与所述第二测量部件(3)的量程不同，所述第一测量部件(3)与所述第二测量部件(3)中，一者安装于所述第一端部的外壁，另一者安装于所述第二端部的外壁。
  16. 根据权利要求14所述的医用检测设备，其特征在于，所述医用检测设备还包括数据传输组件(2)；
    所述影像部件(4)包括镜头(41)和图像传感器(42)，所述镜头(41)与所述图像传感器(42)通过机械结构和/或胶水连接；
    所述图像传感器(42)与所述数据传输组件(2)电连接或信号连接，所述镜头(4)与所述数据传输组件(2)通过机械结构和/或胶水连接。
  17. 根据权利要求16所述的医用检测设备，其特征在于，所述镜头(41)安装于所述壳体(1)的内腔，且所述镜头(41)具有有效成像角度α1，所述透明部(11)能够覆盖所述有效成像角度α1所在的空间；
    所述图像传感器(42)具有显示图像角度α2，所述透明部(11)能够覆盖所述显示图像角度α2所在的空间，且α1＞α2；
    所述测量部件(3)安装于所述壳体(1)的外壁，且位于所述有效成像角度α1与所述显示图像角度α2之间的空间；
    所述数据传输组件(2)能够读取所述测量部件(3)的数据。
  18. 根据权利要求16所述的医用检测设备，其特征在于，所述镜头(41)安装于所述壳体(1)的内腔，且所述镜头(41)具有有效成像角度α1，所述透明部(11)能够覆盖所述有效成像角度α1所在的空间；
    所述图像传感器(42)具有显示图像角度α2，所述透明部(11)能够覆盖所述显示图像角度α2所在的空间，且α1＞α2；
    所述测量部件(3)安装于所述壳体(1)的外壁，且位于所述显示图像角度α2所占据的空间；
    所述图像传感器(42)能够识别所述测量部件(3)的数据。
  19. 根据权利要求18所述的医用检测设备，其特征在于，所述测量部件(3)位于所述显示图像角度α2所占据的空间的中部。
  20. 根据权利要求1～12中任一项所述的医用检测设备，其特征在于，所述测量部件(3)通过透明胶材(32)粘贴于所述壳体(1)的外壁。
  21. 根据权利要求20所述的医用检测设备，其特征在于，所述测量部件(3)还通过封边胶(14)与所述壳体(1)的外壁粘连，所述封边胶(14)包覆所述测量部件(3)的外边缘。
  22. 根据权利要求1～12中任一项所述的医用检测设备，其特征在于，所述壳体(1)为胶囊式结构；
    所述医用检测设备为胶囊式内窥镜。
  23. 一种医用检测设备的测量部件(3)，其特征在于，所述测量部件(3)包括聚离子凝胶和染料，所述染料填充于所述聚离子凝胶中；
    待测量参数的浓度不同时，所述染料能够变色。
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