An exhaled breath condensate collection device and methods of use thereof
Patent Information
- Application Number
- CN202611303547.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-08-26
- Publication Date
- 2026-10-20
AI Technical Summary
[0006]针对上述问题,本发明的目的是提供一种呼出气冷凝液收集装置及其使用方法,用于解决目前的呼出气冷凝液收集装置冷凝效果不理想,获得到的冷凝液的温度不稳定的问题
(一)本发明公开了一种呼出气冷凝液收集装置,包括机体、刮板、漏斗和冷凝模块和口鼻罩,机体包括收集架部,所述收集架部的顶面放置有刮板,所述刮板下方配置有漏斗槽,所述漏斗槽的正下方设置有冷凝液收集瓶;漏斗设置在所述漏斗槽内,所述漏斗的上部带有引流口;冷凝模块包括冷凝模块外壳,所述冷凝模块外壳的底端设置在所述收集架部的顶面,且所述刮板设置在所述冷凝模块外壳内, 所述冷凝模块外壳内设置有一个冷凝基板,所述冷凝基板的下方设置有冷凝棒阵列,所述冷凝基板的两端分别设置有左半导体制冷片和右半导体制冷片,所述左半导体制冷片和所述右半导体制冷片的一端吸热形成冷端,另一端放热形成热端;所述冷凝棒阵列由若干个冷凝棒紧密排列而成,每个冷凝棒内填充有相变材料,每个所述冷凝棒的取冷端与所述左半导体制冷片或所述右半导体制冷片的冷端接触且紧密贴合,每个所述冷凝棒的放冷端穿过所述刮板并露出放冷端的端头,且所述冷凝棒阵列的冷凝棒的放冷端与所述漏斗上部的引流口相对;所述口鼻罩带有引流管,所述漏斗的引流口与所述引流管的出气端可拆卸对接;其中,所述口鼻罩用于覆盖在受试者的口鼻区域,受试者呼出的气体通过所述引流管输送至所述漏斗的引流口,弥漫在所述漏斗的上部,当呼出气接触到所述冷凝棒阵列的冷凝棒的放冷端时,呼出气遇冷凝结变为液体形成冷凝液,冷凝液附着于冷凝棒的外表面并顺着冷凝棒流入至漏斗的内壁上,再顺着所述漏斗的内壁流入至冷凝液收集瓶内储存。本发明采用半导体制冷片和冷凝棒阵列,利用半导体制冷片制冷和冷凝棒储存的冷能使气体遇冷凝结成液体,实现对于受试者呼出的气体的冷凝及其冷凝液的收集,与现有的呼出气冷凝液收集装置相比,首先,制冷效果大大提高;其次,不仅冷凝时效减少,冷凝液量增加,即提高了呼出气的冷凝效果,而且最终获得的冷凝液的温度非常稳定。
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Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, specifically to an exhaled breath condensate collection device and its usage method. Background Technology
[0002] Exhaled breath condensate (EBC) non-invasive sampling technology has been widely used for biomarker detection in lung tumors, chronic airway diseases, and respiratory infections. As clinical testing evolves towards trace detection and multi-omics targeted detection of proteins, metabolism, and nucleic acids, more stringent requirements are being placed on the accuracy of condensation temperature control, sample purity, and the fidelity of trace component recovery from the sampling device.
[0003] The development of current technologies has mainly gone through three stages: experimental prototypes, commercially portable devices, and clinical-grade active workstations. In the early experimental prototype stage, collection devices mostly relied on passive pre-cooling and condensation using ice-water mixtures or liquid nitrogen. These simple devices lacked active temperature control modules, resulting in inconsistent condensation temperatures that were highly susceptible to fluctuations in the external environment and subject ventilation, leading to low heat exchange efficiency, large batch-to-batch variations in output, and extremely poor sample uniformity. Due to their extreme dependence on external ultra-cold media, their application was limited to controlled laboratory conditions, making them completely unsuitable for use in wards, outpatient clinics, or homes. For devices in the commercially portable stage (such as the R-Tube using pre-cooled aluminum tubes), while the overall size was significantly optimized, serious structural defects were exposed. These portable devices generally suffer from poor isolation from oral saliva contamination; oral collection is extremely prone to contamination by saliva and oral water vapor condensate, severely contaminating and diluting lung biomarkers. In contrast, clinical-grade active devices provide a constant cold source through a built-in refrigeration cycle system, achieving quantification and absolute control of condensation parameters and stable operating performance. However, its internal mechanical structure is bulky and the overall weight is heavy. It also relies heavily on a stable external AC power supply, resulting in extremely poor portability and making it unsuitable for lightweight, mobile monitoring scenarios such as primary healthcare institutions, mobile screening vehicles, bedside monitoring in wards, and routine home monitoring. More importantly, even with breakthroughs in thermodynamic control, these workstations have not fundamentally revolutionized the respiratory interface and remain highly susceptible to interference from oral contamination and dead space condensate during actual sampling.
[0004] Existing equipment consistently struggles to simultaneously achieve high integration and portability, precise and controllable temperature control, absolute isolation from oral contamination, and non-destructive full recovery of trace samples. Clinical practice and research urgently require a novel collection device that incorporates systematic innovations in respiratory isolation mechanisms, physical condensation configurations, and gas-liquid separation methods to completely overcome current technological bottlenecks.
[0005] In summary, current exhaled breath condensate collection devices are not ideal in terms of collecting exhaled breath condensate (not only because of the long condensation time, but also because of the small amount of condensate collected), and the temperature of the collected condensate is unstable. Summary of the Invention
[0006] To address the aforementioned problems, the present invention aims to provide an exhaled breath condensate collection device and its usage method, which solves the problems of unsatisfactory condensation effect and unstable temperature of the obtained condensate in current exhaled breath condensate collection devices.
[0007] To achieve the above objectives, the present invention adopts the following technical solution: In a first aspect, the present invention discloses an exhaled breath condensate collection device, comprising: The machine body includes a collection rack, a scraper is placed on the top surface of the collection rack, a funnel groove is arranged below the scraper, and a condensate collection bottle is arranged directly below the funnel groove. A funnel is disposed within the funnel groove, and the upper part of the funnel has a drain port; A condensing module includes a condensing module housing. The bottom end of the condensing module housing is located on the top surface of the collecting rack. The scraper is located inside the condensing module housing. A condensing substrate is located inside the condensing module housing. A condensing rod array is located below the condensing substrate. A left and a right semiconductor refrigeration chip are respectively located at both ends of the condensing substrate. One end of the left and right semiconductor refrigeration chips absorbs heat to form a cold end, and the other end releases heat to form a hot end. The condensing rod array consists of several condensing rods arranged closely together. Each condensing rod is filled with a phase change material. The cold-absorbing end of each condensing rod is in contact with and tightly fitted to the cold end of the left or right semiconductor refrigeration chip. The cold-releasing end of each condensing rod passes through the scraper and protrudes from the end of the cold-releasing end. The cold-releasing ends of the condensing rods in the condensing rod array are opposite to the drain port at the top of the funnel. A mouth and nose mask, wherein the mouth and nose mask is equipped with a drainage tube, and the drainage port of the funnel is detachably connected to the air outlet of the drainage tube; The mouth and nose mask is used to cover the mouth and nose area of the subject. The air exhaled by the subject is delivered to the drainage port of the funnel through the drainage tube and diffuses in the upper part of the funnel. When the exhaled air comes into contact with the cooling end of the condenser rod of the condenser rod array, the exhaled air condenses into liquid and forms condensate. The condensate adheres to the outer surface of the condenser rod and flows down the condenser rod into the inner wall of the funnel, and then flows down the inner wall of the funnel into the condensate collection bottle for storage.
[0008] Preferably, an ear plate is provided at the middle of the outer side of the scraper, and an ear plate movable notch is provided at the middle of the bottom end of the condensing module housing. The scraper is slidably disposed inside the condensing module housing, and the ear plate is located within the ear plate movable notch. When the ear plate is pressed, the ear plate can move from top to bottom along the ear plate movable notch, thereby scraping off the condensate droplets attached to the surface of the condensing rod from top to bottom.
[0009] Preferably, a left thermoelectric cooler slot and a right thermoelectric cooler slot are respectively provided at both ends of the condensation substrate, and the left thermoelectric cooler and the right thermoelectric cooler are respectively embedded in the left thermoelectric cooler slot and the right thermoelectric cooler slot of the condensation substrate.
[0010] Preferably, the scraper is densely covered with condenser rod holes, one condenser rod of the condenser rod array is vertically inserted into one condenser rod hole of the scraper, and the plurality of condenser rod holes of the scraper correspond one-to-one with the plurality of condenser rods of the condenser rod array. Each condenser rod hole can only accommodate one condenser rod. When the condenser rods of the condenser rod array are pulled upward from their corresponding condenser rod holes, the condenser rod holes can brush off the liquid droplets attached to the outer wall of the corresponding condenser rod.
[0011] Preferably, the condenser module housing has openings at both ends, the bottom end of the condenser module housing is disposed on the scraper, and the top end of the condenser module housing is provided with a top cover.
[0012] Preferably, the hot end of the left or right thermoelectric cooler is provided with a heat sink, and a left fan and a right fan are respectively provided at both ends of the heat sink; the scraper, the condensation substrate, the heat sink, the left fan and the right fan and the top cover are sequentially installed inside the condensation module housing from bottom to top.
[0013] Preferably, the main body further includes a main unit housing, which is located close to the rack housing and the two are arranged side by side; a controller is disposed inside the main unit housing, and the left and right thermoelectric coolers are respectively connected to the controller via wires.
[0014] Preferably, the main unit housing is further equipped with a timer and a temperature sensor, the temperature sensor being located at the condenser rod array and close to the cooling end of the condenser rods of the condenser rod array; The main unit is equipped with a display screen. The timer, the temperature sensor, and the display screen are respectively connected to the controller; The temperature sensor is used to collect the temperature of the cooling end of the condenser rods in the condenser rod array. The timer is used to record working time; The display screen is used to show the working time and condensation temperature in real time.
[0015] Secondly, the present invention also discloses a method of using the above-mentioned exhaled breath condensate collection device, comprising: Step A: The subject wears a mouth and nose mask, which is used to cover the subject's mouth and nose area. The subject breathes naturally, and the exhaled air is delivered to the drainage port of the funnel through the drainage tube and diffuses in the upper part of the funnel. Step B: When the exhaled air comes into contact with the cooling end of the condenser rod of the condenser rod array, the exhaled air condenses into liquid upon cooling, forming condensate, which adheres to the outer surface of the condenser rod. Step D: The condensate flows down the inner wall of the funnel into the condensate collection bottle for storage.
[0016] The method further includes the following step between step B and step D: Step C: Press the ear plate, and the ear plate moves from top to bottom along the movable notch of the ear plate, so that the scraper scrapes off the condensate droplets attached to the surface of the condenser rod from top to bottom. The scraped-off condensate flows down the condenser rod into the inner wall of the funnel.
[0017] Compared with the prior art, the beneficial effects of the present invention are as follows: (I) This invention discloses an exhaled breath condensate collection device, comprising a body, a scraper, a funnel, a condensation module, and an oral / nasal mask. The body includes a collection frame, on the top surface of which a scraper is placed. A funnel groove is disposed below the scraper, and a condensate collection bottle is disposed directly below the funnel groove. The funnel is disposed within the funnel groove, and its upper part has a drain port. The condensation module includes a condensation module housing, the bottom end of which is disposed on the top surface of the collection frame, and the scraper is disposed within the condensation module housing. A condensing substrate is disposed inside the housing of the condensing module. An array of condensing rods is disposed below the condensing substrate. A left and right thermoelectric cooler are respectively disposed at both ends of the condensing substrate. One end of each thermoelectric cooler absorbs heat to form a cold end, and the other end releases heat to form a hot end. The array of condensing rods consists of several closely arranged condensing rods, each filled with a phase change material. The cooling end of each condensing rod is in contact with and tightly fitted to the cold end of the left or right thermoelectric cooler. The cooling end of each condensing rod passes through the scraper and protrudes from its end. The cooling end of the condenser rod of the condenser rod array is opposite to the drainage port at the top of the funnel; the oropharyngeal mask is equipped with a drainage tube, and the drainage port of the funnel is detachably connected to the air outlet end of the drainage tube; wherein, the oropharyngeal mask is used to cover the mouth and nose area of the subject, and the air exhaled by the subject is delivered to the drainage port of the funnel through the drainage tube, and diffuses in the upper part of the funnel. When the exhaled air comes into contact with the cooling end of the condenser rod of the condenser rod array, the exhaled air condenses into liquid upon cooling, forming condensate. The condensate adheres to the outer surface of the condenser rod and flows down the condenser rod to the inner wall of the funnel, and then flows down the inner wall of the funnel into the condensate collection bottle for storage. This invention employs a semiconductor cooling chip and a condenser array. By utilizing the cooling energy stored in the semiconductor cooling chip and the condenser array, the gas is condensed into a liquid upon contact with the condenser, thereby achieving the condensation of the subject's exhaled gas and the collection of the condensate. Compared with existing exhaled gas condensate collection devices, firstly, the cooling effect is greatly improved; secondly, not only is the condensation time reduced and the amount of condensate increased, thus improving the condensation effect of exhaled gas, but the temperature of the final condensate is also very stable.
[0018] (II) The exhaled breath condensate collection device disclosed in this invention has an ear plate located at the center of the outer side of the scraper, and an ear plate movable notch located at the center of the bottom end of the condensation module housing. The scraper is slidably disposed within the condensation module housing, and the ear plate is located within the ear plate movable notch. When the ear plate is pressed, the ear plate can move from top to bottom along the ear plate movable notch, thereby scraping away the condensate droplets adhering to the surface of the condensation rod from top to bottom. Based on the rapid cooling of semiconductor refrigeration and the three-dimensional condensation of the array cooling rod, the exhaled breath condensate collection device disclosed in this invention addresses the problem of high solid-liquid interface retention rate of trace condensate under the traditional passive gravity dripping mode. This device integrates a scraper that is geometrically closely matched to the array cooling rod. It actively disrupts the adhesion tension of condensate droplets on the metal surface, overcoming the fluid wall-hanging effect. This physical intervention mechanism effectively reduces the non-specific adsorption of low-abundance macromolecular markers at the contact interface and reduces the probability of secondary volatilization of volatile organic compounds, thereby improving the absolute recovery rate of targeted trace components. This invention combines semiconductor cooling for rapid cooling and array cooling rods for three-dimensional condensation with mechanical scraping by a scraper, achieving integrated sampling. Attached Figure Description
[0019] Figure 1 This is a schematic diagram of the external structure of the exhaled breath condensate collection device provided in Embodiment 1 of the present invention; Figure 2 yes Figure 1 Exploded view; Figure 3 yes Figure 2 A partially enlarged schematic diagram of the condenser module; Figure 4 This is a schematic diagram of the connection of the electrical equipment inside the exhaled air condensate collection device provided in Embodiment 1 of the present invention.
[0020] Explanation of reference numerals in the attached drawings: 1-body, 11-collection rack, 111-funnel trough, 112-condensate collection bottle; 12-main unit box; 2-Scraper, 20-Condenser rod hole, 21-Ear plate; 3-Function funnel, 30-Drainage port; 4-Condensing module, 40-Top cover, 41-Condensing module housing, 42-Condensing substrate, 410-Ear plate movable notch; 43-Condensing rod array, 441-Left thermoelectric cooler, 442-Right thermoelectric cooler, 45-Heat sink, 461-Left fan, 462-Right fan; 5-Controller, 51-Timer, 52-Temperature sensor, 53-Display. Detailed Implementation
[0021] Exemplary embodiments of the invention will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the invention and to fully convey the scope of the invention to those skilled in the art.
[0022] This invention mainly utilizes two existing technologies—a semiconductor cooling chip and a condenser rod.
[0023] A thermoelectric cooler, also known as a semiconductor refrigeration chip, is a solid-state heat pump based on the Peltier effect. Its core working principle is that when direct current passes through a coupler composed of N-type and P-type semiconductor materials connected in series, heat is absorbed at one end (cold end) and released at the other (hot end), thus achieving heat transfer and cooling. This device has no moving parts, produces no noise, requires no refrigerant, and features small size, high reliability, precise temperature control, and reversible hot and cold ends (heating is achieved by changing the direction of the current). However, its coefficient of performance (COP) is typically lower than that of traditional compressor refrigeration systems. Therefore, it is mainly used in low-power refrigeration, precision temperature control, space-constrained applications, or applications requiring high reliability, such as electronic equipment cooling, lasers, medical instruments, optical communication modules, and automotive refrigerators.
[0024] A "condenser rod," also known as a "cooling rod," is filled with a phase change material. The phase change material acts as a cold storage medium, absorbing and storing cold energy when cooled at low temperatures. Then, by contacting a gas, the gas condenses into a liquid, while the phase change material releases the stored cold energy, thus raising its temperature. The phase change material is used in a cycle by storing and releasing cold energy when cooled at low temperatures and raising its temperature.
[0025] This invention employs a mature refrigeration technology—a semiconductor refrigeration chip—to generate cold mass, providing a low temperature for the condenser bars of a condenser bar array. Several condenser bars are arranged closely together to form a condenser bar array, which condenses gas into a liquid. This invention utilizes the cooling energy of the semiconductor refrigeration chip and the cold energy stored in the condenser bars to condense gas into a liquid upon contact with the cold air, achieving the condensation of the subject's exhaled gas and the collection of the condensate. Compared to existing exhaled gas condensate collection devices, firstly, the cooling effect is significantly improved; secondly, not only is the condensation time reduced and the condensate volume increased, thus improving the condensation effect of exhaled gas, but the final temperature of the obtained condensate is also very stable.
[0026] Example 1: A device for collecting exhaled breath condensate Embodiment 1 of the present invention provides an exhaled breath condensate collection device, the structure of which is described in detail below.
[0027] refer to Figures 1 to 3 The exhaled condensate collection device includes a body 1, a scraper 2, a funnel 3, a condensation module 4, and an oral and nasal mask, wherein the oral and nasal mask is used as a consumable during the collection of the subject's exhaled condensate.
[0028] The body 1 includes a collection rack 11, a scraper 2 is placed on the top surface of the collection rack 11, a funnel groove 111 is arranged below the scraper 2, and a condensate collection bottle 112 is arranged directly below the funnel groove 111. The main body of the funnel 3 is a transparent inverted cone structure, which is set in the funnel groove 111. The upper part of the funnel 3 has a drain port 30. The condensing module 4 includes a condensing module housing 41, the bottom of which is disposed on the scraper 2. A condensing substrate 42 is disposed inside the condensing module housing 41. A condensing rod array 43 is disposed below the condensing substrate 42. A left thermoelectric cooler 441 and a right thermoelectric cooler 442 are respectively disposed at both ends of the condensing substrate 42. One end of the left thermoelectric cooler 441 and the right thermoelectric cooler 442 absorbs heat to form a cold end, and the other end releases heat to form a hot end. The condensing rod array 43 is composed of several condensing rods arranged closely together. Each condensing rod is filled with a phase change material. The cold-absorbing end of each condensing rod is in contact with and tightly fitted to the cold end of the left thermoelectric cooler 441 or the right thermoelectric cooler 442. The cold-releasing end of each condensing rod passes through the scraper 2 and protrudes from the end of the cold-releasing end. The cold-releasing end of the condensing rods in the condensing rod array 43 is opposite to the drain port 30 at the top of the funnel 3. The mouth and nose mask is equipped with a drainage tube, and the drainage port 30 of the funnel 3 is detachably connected to the air outlet end of the drainage tube. The nasal mask is used to cover the mouth and nose area of the subject. The gas exhaled by the subject is delivered to the drainage port 30 of the funnel 3 through the drainage tube and diffuses in the upper part of the funnel 3. The transmission path of the exhaled gas is: nasal mask → drainage tube → drainage port → upper part of funnel → condenser array.
[0029] When exhaled air comes into contact with the cooling end of the condenser rod of the condenser rod array 43, the exhaled air instantly condenses into liquid to form condensate. The condensate adheres to the outer surface of the condenser rod and flows down the condenser rod into the inner wall of the funnel 3, and then flows down the inner wall of the funnel 3 into the condensate collection bottle 112 for storage, thereby realizing the collection of the subject's exhaled air condensate.
[0030] As is common knowledge, the nasal mask is made of medical-grade soft silicone material, which conforms to the physiological contour of the human nasal nostrils, has excellent sealing and fit, can effectively prevent air leakage during exhalation, is suitable for people of different ages and nasal shapes, is non-invasive and painless, has a wide range of applicability, achieves pure nasal independent exhalation collection, effectively avoids interference from oral gas, conforms to the natural breathing habits of the human body, greatly improves the comfort and cooperation of the subject during sampling, and is suitable for large-scale non-invasive screening scenarios.
[0031] To effectively isolate external ambient temperature interference, the outer shell 41 of the condensation module is made of thermal insulation material.
[0032] In order to collect the condensate droplets attached to the surface of the condenser rod and improve the collection effect of exhaled condensate, an ear plate 21 is provided in the middle of the outer side of the scraper 2, and an ear plate movable notch 410 is provided in the middle of the bottom end of the condenser module housing 41. The scraper 2 is slidably disposed in the condenser module housing 41, and the ear plate 21 is located in the ear plate movable notch 410.
[0033] When the ear plate 21 is pressed, the ear plate 21 can move from top to bottom along the ear plate movable notch 410, thereby causing the scraper 2 to scrape off the condensate droplets attached to the surface of the condenser rod from top to bottom.
[0034] In one specific embodiment, the condensation substrate 42 is provided with a left semiconductor refrigeration chip groove and a right semiconductor refrigeration chip groove at both ends, and the left semiconductor refrigeration chip 441 and the right semiconductor refrigeration chip 442 are respectively embedded in the left semiconductor refrigeration chip groove and the right semiconductor refrigeration chip groove of the condensation substrate 42.
[0035] More specifically, the scraper 2 is densely covered with condenser rod holes 20, and one condenser rod of the condenser rod array 43 is vertically inserted into one condenser rod hole 20 of the scraper 2, and the plurality of condenser rod holes 20 of the scraper 2 correspond one-to-one with the plurality of condenser rods of the condenser rod array 43.
[0036] To completely eliminate the problem of sample residue adhering to the wall, it is necessary to brush off the condensate adhering to the outer surface of the condenser after collection. For this purpose, each condenser hole 20 can only accommodate one condenser. When the condenser of the condenser array 43 is pulled upward from its corresponding condenser hole 20, the condenser hole 20 can brush off the droplets adhering to the outer wall of the corresponding condenser.
[0037] Specifically, the left thermoelectric cooler 441 and the right thermoelectric cooler 442 are fluorine-free thermoelectric coolers. Using fluorine-free thermoelectric coolers to perform the cooling operation eliminates the need for refrigerants, making it environmentally friendly and safe, operating without noise, and featuring a compact overall structure that is highly compatible with the integrated design requirements of portable devices.
[0038] Specifically, the scraper 2 is made of flexible and wear-resistant medical material. The inner diameter of the condenser rod hole 20 is precisely matched with the outer diameter of the condenser rod. The whole piece is fitted on the outside of the condenser rod and can slide smoothly up and down along the axis of the condenser rod. The inner side of the scraper 2 fits the condenser rod without gaps. After sampling, all attached condensate droplets can be scraped off from all directions without dead angles.
[0039] Specifically, the condenser module housing 41 has openings at both ends, the bottom end of the condenser module housing 41 is disposed on the scraper 2, and the top end of the condenser module housing 41 is provided with a top cover 40.
[0040] More specifically, the hot end of the left thermoelectric cooler 441 or the right thermoelectric cooler 442 is provided with a heat sink 45, and the two ends of the heat sink 45 are respectively provided with a left fan 461 and a right fan 462.
[0041] In order to obtain a compact and highly integrated device, the scraper 2, the condenser substrate 42, the heat sink 45, the left fan 461 and the right fan 462 and the top cover 40 are installed in the condenser module housing 41 from bottom to top.
[0042] In order to display the working time and condensation temperature in real time, the exhaled condensate collection device is also equipped with a main unit box 12, which is close to the collection rack 11 and the two are arranged side by side. The main unit 12 is equipped with a controller 5, and the left thermoelectric cooler 441 and the right thermoelectric cooler 442 are respectively connected to the controller 5 via wires.
[0043] More specifically, the main unit housing 12 is also equipped with a timer 51 and a temperature sensor 52. The temperature sensor 52 is located at the condenser rod array 43 and is close to the cooling end of the condenser rod of the condenser rod array 43. The main unit 12 is equipped with a display screen 53; The timer 51, the temperature sensor 52, and the display screen 53 are respectively connected to the controller; The temperature sensor 52 is used to collect the temperature of the cooling end of the condenser rod of the condenser rod array 43. The timer 51 is used to record working time; The display screen 53 is used to display the working time and condensation temperature in real time.
[0044] To quickly reach a stable cooling operating temperature, the start-up cooling time of this exhaled air condensate collection device is ≤3 minutes.
[0045] To standardize the sampling process, the duration of a single standard sampling session is 5 minutes.
[0046] To achieve standardized sampling of 5 minutes, sufficient sample volume is required to meet the needs of multi-omics detection, with a single qualified output volume ≥ 500 μl.
[0047] The condensation collection efficiency of this exhaled breath condensate collection device is improved by more than 40% compared to traditional planar condensate collection devices.
[0048] The sample qualification rate of this exhaled condensate collection device is ≥98%, including clinical validation. The sample purity and volume meet the multi-omics testing standards related to lung cancer.
[0049] The dimensions and weight of the exhaled breath condensate collection device are as follows: the overall dimensions are 30cm long, 20cm wide, and 25cm high, and the overall weight is approximately 1.2kg. It is compact, lightweight, and portable, supports handheld operation and mobile sampling in multiple scenarios, and has excellent portability and on-site adaptability.
[0050] The device collects exhaled air condensate, which can reflect the local microenvironment of the lungs and the systemic metabolic status. It is mainly suitable for early lung cancer screening, lung cancer tumor staging, neoadjuvant therapy resistance assessment for lung cancer, and non-invasive sample collection scenarios for various respiratory and systemic metabolic diseases.
[0051] Example 2: Method of using an exhaled breath condensate collection device Embodiment 2 of the present invention provides a method for using an exhaled condensate collection device, employing the exhaled condensate collection device of Embodiment 1. Preparation before use includes: firstly, turning on the left thermoelectric cooler 441 and the right thermoelectric cooler 442 to rapidly cool the condenser rods of the condenser rod array 43 and stabilize them at a preset operating temperature. The method of use includes the following steps: Step A: The subject wears a mouth and nose mask, which is used to cover the subject's mouth and nose area. The subject breathes naturally, and the exhaled air is delivered to the drainage port 30 of the funnel 3 through the drainage tube and diffuses in the upper part of the funnel 3. Step B: When the exhaled air comes into contact with the cooling end of the condenser rod of the condenser rod array 43, the exhaled air condenses into liquid upon cooling, forming condensate, which adheres to the outer surface of the condenser rod. Step C: Press the ear plate 21, and the ear plate 21 moves from top to bottom along the ear plate movable notch 410, so that the scraper 2 scrapes off the condensate droplets attached to the surface of the condenser rod from top to bottom, and the scraped condensate flows down the condenser rod into the inner wall of the funnel 3. Step D: The condensate flows along the inner wall of the funnel 3 into the condensate collection bottle 112 for storage.
[0052] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.
Claims
1. A device for collecting exhaled breath condensate, characterized in that, include: The body (1) includes a collection rack (11), a scraper (2) is placed on the top surface of the collection rack (11), a funnel groove (111) is arranged below the scraper (2), and a condensate collection bottle (112) is arranged directly below the funnel groove (111). A funnel (3) is provided in the funnel groove (111), and the upper part of the funnel (3) has a drain port (30). The condensing module (4) includes a condensing module housing (41), the bottom end of which is disposed on the top surface of the collecting rack (11), and the scraper (2) is disposed inside the condensing module housing (41). A condensing substrate (42) is provided inside the outer shell (41) of the condensing module. A condensing rod array (43) is provided below the condensing substrate (42). A left semiconductor refrigeration chip (441) and a right semiconductor refrigeration chip (442) are respectively provided at both ends of the condensing substrate (42). One end of the left semiconductor refrigeration chip (441) and the right semiconductor refrigeration chip (442) absorbs heat to form a cold end, and the other end releases heat to form a hot end. The condensing rod array (43) is composed of several condensing rods arranged closely. Each condensing rod is filled with phase change material. The cold end of each condensing rod is in contact with and closely attached to the cold end of the left semiconductor refrigeration chip (441) or the right semiconductor refrigeration chip (442). The cold end of each condensing rod passes through the scraper (2) and exposes the end of the cold end. The cold end of the condensing rod of the condensing rod array (43) is opposite to the drain port (30) at the top of the funnel (3). The mouth and nose mask is equipped with a drainage tube, and the drainage port (30) of the funnel (3) is detachably connected to the air outlet of the drainage tube. The mouth and nose mask is used to cover the mouth and nose area of the subject. The gas exhaled by the subject is delivered to the drainage port (30) of the funnel (3) through the drainage tube and diffuses in the upper part of the funnel (3). When the exhaled gas comes into contact with the cooling end of the condenser rod of the condenser rod array (43), the exhaled gas condenses into liquid and forms condensate. The condensate adheres to the outer surface of the condenser rod and flows along the condenser rod into the inner wall of the funnel (3), and then flows along the inner wall of the funnel (3) into the condensate collection bottle (112) for storage.
2. The exhaled breath condensate collection device according to claim 1, characterized in that, An ear plate (21) is provided on the middle of the outer side of the scraper (2). The bottom center of the condenser module housing (41) is provided with an ear plate movable notch (410). The scraper (2) is slidably disposed inside the housing (41) of the condenser module, and the ear plate (21) is located inside the ear plate movable notch (410); When the ear plate (21) is pressed, the ear plate (21) can move from top to bottom along the ear plate movable notch (410), thereby causing the scraper (2) to scrape off the condensate droplets attached to the surface of the condenser rod from top to bottom.
3. The exhaled breath condensate collection device according to claim 2, characterized in that, The condensing substrate (42) has a left semiconductor refrigeration chip groove and a right semiconductor refrigeration chip groove at its two ends, and the left semiconductor refrigeration chip (441) and the right semiconductor refrigeration chip (442) are respectively embedded in the left semiconductor refrigeration chip groove and the right semiconductor refrigeration chip groove of the condensing substrate (42).
4. The exhaled breath condensate collection device according to claim 3, characterized in that, The scraper (2) is densely covered with condenser rod holes (20). One condenser rod of the condenser rod array (43) is vertically inserted into one condenser rod hole (20) of the scraper (2), and the plurality of condenser rod holes (20) of the scraper (2) correspond one-to-one with the plurality of condenser rods of the condenser rod array (43); Each condenser hole (20) can only accommodate one condenser. When the condenser of the condenser array (43) is pulled upward from its corresponding condenser hole (20), the condenser hole (20) can brush off the droplets attached to the outer wall of the corresponding condenser.
5. The exhaled breath condensate collection device according to claim 4, characterized in that, The condenser module housing (41) has openings at both ends, the bottom end of the condenser module housing (41) is disposed on the scraper (2), and the top end of the condenser module housing (41) is provided with a top cover (40).
6. The exhaled breath condensate collection device according to claim 5, characterized in that, The hot end of the left semiconductor cooling chip (441) or the right semiconductor cooling chip (442) is provided with a heat sink (45), and the two ends of the heat sink (45) are respectively provided with a left fan (461) and a right fan (462). The scraper (2), the condenser substrate (42), the heat sink (45), the left fan (461), the right fan (462), and the top cover (40) are installed in the condenser module housing (41) from bottom to top.
7. The exhaled breath condensate collection device according to claim 6, characterized in that, The body (1) also includes a main unit box (12), which is close to the rack section (11) and the two are arranged side by side. The main unit (12) is equipped with a controller (5), and the left thermoelectric cooler (441) and the right thermoelectric cooler (442) are respectively connected to the controller (5) by wires.
8. The exhaled breath condensate collection device according to claim 7, characterized in that, The main unit (12) is also equipped with a timer (51) and a temperature sensor (52). The temperature sensor (52) is located on the condenser rod array (43) and close to the cooling end of the condenser rod of the condenser rod array (43). The main unit (12) is equipped with a display screen (53); The timer (51), the temperature sensor (52), and the display screen (53) are respectively connected to the controller; The temperature sensor (52) is used to collect the temperature of the cooling end of the condenser rod of the condenser rod array (43); The timer (51) is used to record working time; The display screen (53) is used to display the working time and condensation temperature in real time.
9. A method of using the exhaled breath condensate collection device according to claim 8, characterized in that, include: Step A: The subject wears a mouth and nose mask, which is used to cover the subject's mouth and nose area. The subject breathes naturally, and the exhaled air is delivered through the drainage tube to the drainage port (30) of the funnel (3) and diffuses in the upper part of the funnel (3). Step B: When the exhaled air comes into contact with the cooling end of the condenser rod of the condenser rod array (43), the exhaled air condenses into liquid upon contact with the condenser rod and forms condensate, which adheres to the outer surface of the condenser rod. Step D: The condensate flows along the inner wall of the funnel (3) into the condensate collection bottle (112) for storage.
10. The method of using the exhaled breath condensate collection device according to claim 9, characterized in that, Between step B and step D, the following is also included: Step C: Press the ear plate (21), and the ear plate (21) moves from top to bottom along the movable notch (410) of the ear plate, so that the scraper (2) scrapes off the condensate droplets attached to the surface of the condenser rod from top to bottom, and the scraped condensate flows down the condenser rod into the inner wall of the funnel (3).