WO2017177886A1 - Tear collector - Google Patents
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- WO2017177886A1 WO2017177886A1 PCT/CN2017/080033 CN2017080033W WO2017177886A1 WO 2017177886 A1 WO2017177886 A1 WO 2017177886A1 CN 2017080033 W CN2017080033 W CN 2017080033W WO 2017177886 A1 WO2017177886 A1 WO 2017177886A1
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- tear
- collector
- tear collector
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/02—Devices for withdrawing samples
- G01N1/10—Devices for withdrawing samples in the liquid or fluent state
- G01N1/14—Suction devices, e.g. pumps; Ejector devices
Definitions
- the invention belongs to the field of in vitro diagnosis, and in particular relates to a tear collector.
- Ocular ocular tear contains a large number of factors and proteins, which are closely related to the occurrence and development of the disease and the molecular mechanism.
- the diagnosis, differential diagnosis and follow-up of ophthalmic diseases, especially ocular surface diseases, Efficacy judgment and prognosis prediction are important.
- the tear collection method used in clinical research at home and abroad is complicated, and the patient often feels nervous and cannot relax with the medical staff, resulting in the inability to collect tears or the collection effect is not satisfactory.
- the main tear collectors mainly include: glass capillary straws and water-absorbing materials. Due to the shape, material and design of the glass capillary pipette, the following defects are insufficient: the outer diameter of the glass capillary pipette is less than 1mm, and the slender, glass material gives a sharp feeling. When looking directly at the glass capillary tube, the patient is prone to fear or mood.
- the working principle of the water-absorbing material as a tear collector is that the water-absorbing material such as wool polyester contacts the inner side of the lower jaw (the sacral conjunctiva), and the tear liquid is absorbed by the water absorption property of the material, and then the water-absorbing material is placed in the buffer to form a tear-containing active factor and A solution of the protein is then analyzed accordingly.
- the water-absorbing material such as wool polyester contacts the inner side of the lower jaw (the sacral conjunctiva)
- the tear liquid is absorbed by the water absorption property of the material
- the water-absorbing material is placed in the buffer to form a tear-containing active factor and A solution of the protein is then analyzed accordingly.
- the main disadvantages of this type of water-absorbent material tear collector are: First, it is impossible to quantify: the water-absorbing material is used to contact the sacral conjunctiva, and the water-absorbing material is wetted by the tear liquid for collection, but the volume of the absorbed tear liquid cannot be accurately measured, so Quantitative testing or experimentation, but also affect the results of qualitative tests to a certain extent; second, repeated stimulation: in order to enable the water-absorbing material to absorb tears, it is necessary to repeatedly contact the water-absorbing material with the conjunctiva, which may lead to a large amount of reflective secretion of tears.
- the tear film component of the ocular surface changes; third, the patient is discomfort: a large number of nerve endings are distributed on the ocular surface, and the water absorbing material repeatedly contacts the conjunctiva, which may cause discomfort to the patient; fourth, the collected sample is diluted: the tear fluid is adsorbed on the water absorbing material, so The water absorbing material is placed in a buffer, and the tear protein and the active factor are dissolved in the buffer before being analyzed. This process causes the tears of their own sample size to be diluted, making the target analytes, which are inherently low in concentration, more difficult to detect, thus limiting their clinical application. Therefore, in the prior art tear collector, there are mainly technical defects that cannot be simultaneously taken between sampling convenience and quantitative sampling.
- the present invention provides a tear collector for solving the technical problems in the prior art that the tear collector mainly has a convenience between sampling convenience and quantitative sampling.
- the present invention provides a tear collector, the tear collector comprising: a collecting device, a buffer device and a pressing device; a rear end of the collecting device is connected to a front end of the buffer device, and a front end of the pressing device Connected to the rear end of the buffer device.
- the tear collector further comprises: a sealing device; the sealing device is sleeved outside the collecting device and the buffer device.
- the rear end or the upper end of the pressing device is provided with a hole-like structure.
- the collection device is a capillary straw.
- the cushioning device has a shape of a front narrow and a wide tapered structure.
- the pressing device is an elastic pressing device.
- the collection device is a transparent collection device.
- the buffer device is a transparent buffer device.
- the invention also provides the use of a tear collector according to any of the above items for in vitro diagnostic detection sampling.
- the present invention provides a tear collector, the tear collector comprising: a collecting device, a buffer device and a pressing device; a rear end of the collecting device is connected to a front end of the buffer device, and a front end of the pressing device is connected to a rear end of the buffer device.
- the invention provides a tear collector, which uses the collecting device to collect tear liquid. When the tear liquid reaches the connection between the collecting device and the buffer device, the sampling is completed. When the tear liquid needs to be detected, the pressing device can be squeezed. The tears drain out of the tear collector. Compared with the glass capillary straw, the tear collector of the present invention provides better grip for the tester to sample, and at the same time, reduces the fear of the patient.
- the tear collector of the present invention makes it easier to accurately quantify a sample compared to a water absorbent material.
- the tear collector mainly has technical defects that cannot be simultaneously taken into consideration between sampling convenience and quantitative sampling.
- the invention also provides the use of the above-described tear collector for in vitro diagnostic detection sampling.
- FIG. 1 is a schematic structural view of one of the tear collectors provided by the present invention.
- FIG. 2 is another schematic structural view of a tear collector according to the present invention.
- the collecting device 1, the buffer device 2, the pressing device 3, the sealing device 4, and the hole-like structure 31 are included in the collecting device 1, the buffer device 2, the pressing device 3, the sealing device 4, and the hole-like structure 31.
- a tear fluid is provided for the present invention in combination with the following examples.
- the collector is specifically described.
- the present invention provides a tear collector, comprising: a collecting device 1, a buffer device 2 and a pressing device 3; the rear end of the collecting device 1 is connected to the front end of the buffer device 2, and the buffer device 3 The front end is connected to the rear end of the buffer device 1. .
- the tear collector of the present invention collects tear liquid by using the collecting device 1. When the tear liquid reaches the connection between the collecting device 1 and the buffer device 2, the sampling is completed, and after the tearing liquid is collected by the collecting device 1, when the tear is needed At the time of detection, the squeezing device 3 can be squeezed so that the tears are discharged from the tear collector.
- the tear collector of the present invention Compared with the glass capillary straw, the tear collector of the present invention provides better grip for the tester to sample, and at the same time, reduces the fear of the patient.
- the tear collector of the present invention makes it easier to accurately quantify a sample compared to a water absorbent material.
- the tear collector mainly has technical defects that cannot be simultaneously taken into consideration between sampling convenience and quantitative sampling.
- the rear end of the extrusion device 3 of the tear collector of the present invention is provided with a hole-like structure 31.
- the squeeze device 3 of the tear collector provided by the present invention has elasticity and can be squeezed.
- the collecting device 1 is a capillary straw.
- the liquid is aspirated by capillary action (ie, the attraction of the liquid surface to the solid surface).
- capillary action ie, the attraction of the liquid surface to the solid surface.
- the shape of the collecting device 1 is a front fine and thick funnel structure in which the diameter of the front end of the capillary pipe is rapidly increased, and the rear end of the pressing device 3 is at the same time.
- a hole-like structure 31 is provided.
- the inner diameter and length of the capillary pipette determine the volume of liquid absorbed, ie the amount collected.
- the shape of the buffer device 2 is a narrow structure with a narrow front and a wide width. .
- the tapered structure is not only convenient to hold, but also small and round, easy to use and can reduce the fear of patients.
- the pressing device 3 is an elastic pressing device.
- the tear discharge can be achieved with a small force, and the operation is convenient.
- the collecting device 1 is a transparent collecting device
- the buffer device 2 is a transparent buffer device.
- the invention also provides the use of a tear collector comprising any of the above in in vitro diagnostic test sampling.
- a tear collector comprising any of the above in in vitro diagnostic test sampling.
- the above only provides an embodiment for collecting tears, and those skilled in the art can clearly understand that the tear collector of the present invention can be used for various body fluids such as saliva, urine, blood, etc. without any creative labor. Collection work.
- the present invention provides a tear collector having the following advantages.
- safety The tear collector of the present invention has a more rounded structure, so that the part in contact with the patient is smooth and smooth, and it is non-invasive and painless under normal operation, and does not cause damage to the ocular surface of the eye.
- operability The tear collector of the present invention is designed according to the ergonomic principle, so that the length and diameter of the collector are suitable for hand-held and fine operation on the ocular surface.
- the sampling is quick and simple.
- the tear collector design provided by the present invention applies the principle of capillary siphon action, and the collecting device is a smooth and round inner and outer surface capillary tube with a small inner diameter and a hole-like structure at the rear end of the pressing device, tear liquid Will quickly enter the collection device.
- quantitative sampling the volume of the inhaled liquid is precisely controlled by the inner diameter and length of the collecting device, which lays a good foundation for quantitative analysis of the concentration of biomarkers in tears.
- Fifth, sampling and sample integration After collecting the liquid, the tear collector usually needs to be transported to a suitable inspection device (such as a gold standard card) or equipment for inspection.
- the tear collector of the present invention has its own The elastic squeezable rear tube can blow out the tears in the collecting device and the temporary storage device to realize the integration of sampling and sample feeding.
- the tear collector of the present invention solves the technical defects in the prior art that the tear collector mainly has the convenience of sampling and quantitative sampling. At the same time, it has great significance in clinical application and industrial application.
- ocular surface tear contains a lot of factors and proteins, which are closely related to the occurrence and development of the disease and molecular mechanism, but it is not convenient or safe on the market or in clinical practice.
- Effective tear collection device or method the collection and analysis of tear samples is limited to a few professional researchers and scientific research. This is one of the key reasons for the lack of in vitro diagnostic reagents for detecting tears.
- the invention provides a tear collector which has the advantages of convenience, safety and effectiveness.
- the presence or absence of various active factors, protein factors and biomarkers in the tears or their concentrations reflects the health and pathological state of the ocular surface.
- a biomarker factor or protein factor is beneficial to study the molecular pathological mechanism of the disease. Detection of tears is important for the diagnosis, differential diagnosis, follow-up, efficacy judgment and prognosis of ophthalmic diseases, especially ocular surface diseases.
- the tear collector of the present invention can be quantitative, precise, accurate, easy to operate, and convenient. And user experience, there are significant improvements, will provide the possibility and practicality of clinical tear collection, promote the development of tear-related detection technology and the development and application of ophthalmic in vitro diagnostic reagent products, enhance the accurate diagnosis and treatment of ophthalmic diseases .
- the present invention provides a tear collector, comprising: an acquisition device 1, a buffer device 2 and a pressing device 3; the rear end of the collection device 1 is connected to the front end of the buffer device 2, and the front end of the buffer device 3 is The back end of the temporary storage device 1 is connected. .
- the tear collector of the present invention collects tear liquid by using the collecting device 1. When the tear liquid reaches the connection between the collecting device 1 and the buffer device 2, the sampling is completed, and after the tearing liquid is collected by the collecting device 1, when the tear is needed At the time of detection, the squeezing device 3 can be squeezed so that the tears are discharged from the tear collector.
- the tear collector of the present invention Compared with the glass capillary straw, the tear collector of the present invention provides better grip for the tester to sample, and at the same time, reduces the fear of the patient.
- the tear collector of the present invention makes it easier to accurately quantify a sample compared to a water absorbent material.
- the tear collector mainly has technical defects that cannot be simultaneously taken into consideration between sampling convenience and quantitative sampling.
- the present invention also provides the above tear liquid The application of the collector in in vitro diagnostic test sampling.
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Abstract
Description
本申请要求于2016年04月13日提交中国专利局、申请号为201610232017.9、发明名称为“一种泪液采集器”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。The present application claims priority to Chinese Patent Application No. 20161023201, filed on Jun.
本发明属于体外诊断领域，尤其涉及一种泪液采集器。The invention belongs to the field of in vitro diagnosis, and in particular relates to a tear collector.
眼表泪液中含有大量因子和蛋白，与疾病的发生发展和分子机制关系密切，通过获取泪液并进行疾病生物标记物的检测，对眼科疾病，尤其是眼表疾病的诊断、鉴别诊断、随访、疗效判断以及预后预测有重要意义。Ocular ocular tear contains a large number of factors and proteins, which are closely related to the occurrence and development of the disease and the molecular mechanism. Through the acquisition of tears and the detection of disease biomarkers, the diagnosis, differential diagnosis and follow-up of ophthalmic diseases, especially ocular surface diseases, Efficacy judgment and prognosis prediction are important.
目前，国内外临床研究时使用的泪液采集方法操作复杂，并且患者常感觉紧张，无法放松配合医护人员，导致无法采集泪液或采集效果不理想。目前主要使用的泪液采集器主要包括：玻璃毛细吸管和吸水性材料两种泪液采集器。由于玻璃毛细吸管的形状、材质和设计，存在以下不足：玻璃毛细吸管外径多在1mm以内，细长、玻璃材质给人锋利的感觉，当直视玻璃毛细管时，患者易产生恐惧感或心情紧张，不能较好地配合检查者的操作；同时，玻璃毛细吸管太细，检查者不易手持和操作；第三，玻璃毛细吸管的尖端边缘，未经特殊处理，且为玻璃材质，较为锋利，容易造成上皮损伤；第四，吸取泪液后，为了把管腔内的液体吹出，进行下一步检验，通常还需要临时装配额外的装置(如：橡皮洗耳球)，增加操作者的操作步骤，操作更加复杂。吸水性材料作为泪液采集器的工作原理为：羊毛涤纶等吸水材料接触下睑内侧(睑结膜)，利用材料的吸水性能吸取泪液，随后将吸水材料置于缓冲液中，形成含有泪液活性因子和蛋白的溶液，而后进行相应分析。此类吸水性材料的泪液采集器主要存在的缺点为：第一，无法定量：使用吸水材料接触睑结膜，吸水材料被泪液润湿从而进行采集，但无法准确测量已吸取的泪液体积，因此无法进行定量检测或实验，而且也一定程度上影响定性试验的结果；第二，反复刺激：为了使吸水材料能吸取泪液，需将吸水材料反复接触结膜，可能导致泪液大量反射性分泌， 使眼表泪膜成分发生变化；第三，患者不适：眼表分布大量神经末梢，吸水材料反复接触结膜，会造成患者不适；第四，采集的样品被稀释：泪液吸附于吸水材料，因此需将吸水材料置于缓冲液中，待泪液蛋白和活性因子溶于缓冲液后，方可进行分析。这个过程会导致本身样品量极小的泪液被稀释，使得本来浓度就低的目标被分析物更难被检测，从而限制了对其临床应用。因此，现有技术中的泪液采集器，主要存在着采样便捷性和定量取样之间不可同时兼顾的技术缺陷。At present, the tear collection method used in clinical research at home and abroad is complicated, and the patient often feels nervous and cannot relax with the medical staff, resulting in the inability to collect tears or the collection effect is not satisfactory. At present, the main tear collectors mainly include: glass capillary straws and water-absorbing materials. Due to the shape, material and design of the glass capillary pipette, the following defects are insufficient: the outer diameter of the glass capillary pipette is less than 1mm, and the slender, glass material gives a sharp feeling. When looking directly at the glass capillary tube, the patient is prone to fear or mood. Tension, can not better match the operation of the inspector; at the same time, the glass capillary straw is too thin, the inspector is not easy to handle and operate; third, the tip edge of the glass capillary straw is not specially treated, and is made of glass material, which is relatively sharp. It is easy to cause epithelial damage. Fourthly, after taking the tears, in order to blow out the liquid in the lumen, the next step is to test, usually it is necessary to temporarily assemble additional devices (such as rubber-washing balls) to increase the operator's operation steps. The operation is more complicated. The working principle of the water-absorbing material as a tear collector is that the water-absorbing material such as wool polyester contacts the inner side of the lower jaw (the sacral conjunctiva), and the tear liquid is absorbed by the water absorption property of the material, and then the water-absorbing material is placed in the buffer to form a tear-containing active factor and A solution of the protein is then analyzed accordingly. The main disadvantages of this type of water-absorbent material tear collector are: First, it is impossible to quantify: the water-absorbing material is used to contact the sacral conjunctiva, and the water-absorbing material is wetted by the tear liquid for collection, but the volume of the absorbed tear liquid cannot be accurately measured, so Quantitative testing or experimentation, but also affect the results of qualitative tests to a certain extent; second, repeated stimulation: in order to enable the water-absorbing material to absorb tears, it is necessary to repeatedly contact the water-absorbing material with the conjunctiva, which may lead to a large amount of reflective secretion of tears. The tear film component of the ocular surface changes; third, the patient is discomfort: a large number of nerve endings are distributed on the ocular surface, and the water absorbing material repeatedly contacts the conjunctiva, which may cause discomfort to the patient; fourth, the collected sample is diluted: the tear fluid is adsorbed on the water absorbing material, so The water absorbing material is placed in a buffer, and the tear protein and the active factor are dissolved in the buffer before being analyzed. This process causes the tears of their own sample size to be diluted, making the target analytes, which are inherently low in concentration, more difficult to detect, thus limiting their clinical application. Therefore, in the prior art tear collector, there are mainly technical defects that cannot be simultaneously taken between sampling convenience and quantitative sampling.
因此，研发出一种泪液采集器，用于解决现有技术中的泪液采集器，主要存在着采样便捷性和定量取样之间不可同时兼顾的技术缺陷，成为了本领域技术人员亟待解决的问题。Therefore, a tear collector has been developed for solving the tear collector of the prior art, and there are mainly technical defects that cannot be simultaneously taken between sampling convenience and quantitative sampling, and have become an urgent problem to be solved by those skilled in the art. .
发明内容Summary of the invention
有鉴于此，本发明提供了一种泪液采集器，用于解决现有技术中，泪液采集器主要存在着采样便捷性和定量取样之间不可同时兼顾的技术缺陷。In view of this, the present invention provides a tear collector for solving the technical problems in the prior art that the tear collector mainly has a convenience between sampling convenience and quantitative sampling.
本发明提供了一种泪液采集器，所述泪液采集器包括：采集装置、缓冲装置和挤压装置；所述采集装置的后端与所述缓冲装置的前端连接，所述挤压装置的前端与所述缓冲装置的后端连接。The present invention provides a tear collector, the tear collector comprising: a collecting device, a buffer device and a pressing device; a rear end of the collecting device is connected to a front end of the buffer device, and a front end of the pressing device Connected to the rear end of the buffer device.
优选地，所述泪液采集器还包括：密封装置；所述密封装置套在所述采集装置和所述缓冲装置的外部。Preferably, the tear collector further comprises: a sealing device; the sealing device is sleeved outside the collecting device and the buffer device.
优选地，所述挤压装置的后端或上端设置有孔状结构。Preferably, the rear end or the upper end of the pressing device is provided with a hole-like structure.
优选地，所述采集装置为毛细吸管。Preferably, the collection device is a capillary straw.
优选地，所述缓冲装置的形状为前窄后宽的锥形结构。Preferably, the cushioning device has a shape of a front narrow and a wide tapered structure.
优选地，所述挤压装置为弹性挤压装置。Preferably, the pressing device is an elastic pressing device.
优选地，所述采集装置为透明采集装置。Preferably, the collection device is a transparent collection device.
优选地，所述缓冲装置为透明缓冲装置。Preferably, the buffer device is a transparent buffer device.
本发明还提供了一种包括以上任意一项所述的泪液采集器在体外诊断检测取样中的应用。The invention also provides the use of a tear collector according to any of the above items for in vitro diagnostic detection sampling.
综上所述，本发明提供了一种泪液采集器，所述泪液采集器包括：采 集装置、缓冲装置和挤压装置；所述采集装置的后端与所述缓冲装置的前端连接，所述挤压装置的前端与所述缓冲装置的后端连接。本发明提供的一种泪液采集器，利用采集装置采集到泪液，当泪液到达采集装置与缓冲装置的连接处时，采样完毕，当需要对泪液进行检测时，可通过挤压挤压装置，使得泪液排出泪液采集器。与玻璃毛细吸管相比，本发明提供的泪液采集器更好握持便于检测人员采样，同时，也可减轻患者的恐惧感。与吸水性材料相比，本发明提供的泪液采集器更容易对样品进行准确定量。解决了现有技术中，泪液采集器主要存在着采样便捷性和定量取样之间不可同时兼顾的技术缺陷。本发明还提供了上述的泪液采集器在体外诊断检测取样中的应用。In summary, the present invention provides a tear collector, the tear collector comprising: a collecting device, a buffer device and a pressing device; a rear end of the collecting device is connected to a front end of the buffer device, and a front end of the pressing device is connected to a rear end of the buffer device. The invention provides a tear collector, which uses the collecting device to collect tear liquid. When the tear liquid reaches the connection between the collecting device and the buffer device, the sampling is completed. When the tear liquid needs to be detected, the pressing device can be squeezed. The tears drain out of the tear collector. Compared with the glass capillary straw, the tear collector of the present invention provides better grip for the tester to sample, and at the same time, reduces the fear of the patient. The tear collector of the present invention makes it easier to accurately quantify a sample compared to a water absorbent material. In the prior art, the tear collector mainly has technical defects that cannot be simultaneously taken into consideration between sampling convenience and quantitative sampling. The invention also provides the use of the above-described tear collector for in vitro diagnostic detection sampling.
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述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发明的实施例，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，还可以根据提供的附图获得其他的附图。In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the embodiments or the description of the prior art will be briefly described below. Obviously, the drawings in the following description are only It is an embodiment of the present invention, and those skilled in the art can obtain other drawings according to the provided drawings without any creative work.
图1为本发明提供的一种泪液采集器的其中一个结构示意图；1 is a schematic structural view of one of the tear collectors provided by the present invention;
图2为本发明提供的一种泪液采集器的另一个结构示意图；2 is another schematic structural view of a tear collector according to the present invention;
其中，采集装置1、缓冲装置2、挤压装置3、密封装置4和孔状结构31。Among them, the
本发明提供了一种泪液采集器，用于解决现有技术中的泪液采集器，主要存在着采样便捷性和定量取样之间不可同时兼顾的技术缺陷。The invention provides a tear collector for solving the tear collector of the prior art, and mainly has technical defects that cannot be simultaneously taken into consideration between sampling convenience and quantitative sampling.
下面将对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。The technical solutions in the embodiments of the present invention are clearly and completely described below. It is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative efforts are within the scope of the present invention.
为了更详细说明本发明，下面结合实施例对本发明提供的一种泪液采 集器，进行具体地描述。In order to explain the present invention in more detail, a tear fluid is provided for the present invention in combination with the following examples. The collector is specifically described.
请参阅图1和图2，本发明提供了一种泪液采集器，包括：采集装置1、缓冲装置2和挤压装置3；采集装置1的后端与缓冲装置的2前端连接，缓冲装置3的前端与缓冲装置1的后端连接。。本发明提供的一种泪液采集器，利用采集装置1采集到泪液，当泪液到达采集装置1与缓冲装置2的连接处时，采样完毕，利用采集装置1采集到泪液之后，当需要对泪液进行检测时，可挤压挤压装置3，使得泪液排出泪液采集器。与玻璃毛细吸管相比，本发明提供的泪液采集器更好握持便于检测人员采样，同时，也可减轻患者的恐惧感。与吸水性材料相比，本发明提供的泪液采集器更容易对样品进行准确定量。解决了现有技术中，泪液采集器主要存在着采样便捷性和定量取样之间不可同时兼顾的技术缺陷。1 and 2, the present invention provides a tear collector, comprising: a
为了保证采集装置无菌并防止采集到的泪液样品被污染，本发明提供的一种泪液采集器还包括：密封装置4；密封装置4套在采集装置1和缓冲装置2的外部。同时，在泪液采集器还没使用之前，密封装置4可以使得采集装置1的尖端不受到污染和碰撞带来的损坏。In order to ensure the sterility of the collecting device and prevent the collected tear sample from being contaminated, the tear collector of the present invention further comprises: a
为了泪液采集器能通过虹吸毛细管作用快速吸取定量体积的样品，本发明提供的一种泪液采集器的挤压装置3的后端设置有孔状结构31。在泪液采集器采集好泪液后，为了便于泪液的排出，以便进行下一步检测，本发明提供的一种泪液采集器的挤压装置3具有弹性可被挤压。样品采集后，如有需要先把样品与缓冲液混合，可把采集装置1插入缓冲液管内，用手指堵住孔状结构31，挤压挤压装置3，将样品吹入缓冲液管内，再通过释放压力吸取缓冲液进入采集装置1内，然后再次用手指堵住孔状结构31，并同时挤压挤压装置3，把液体吹出。样品采集后，也可以通过用手指堵住孔状结构31，挤压挤压装置3，直接将样品吹入检测装置中的加样孔。In order for the tear collector to quickly absorb a quantitative volume of the sample by siphon capillary action, the rear end of the
为便于采样，本发明实施例中，采集装置1为毛细吸管。利用毛细作用(即：液体表面对固体表面的吸引力)吸取液体。当毛细吸管插入浸润液体中，管内液面上升，高于管外。可通过采集头透明管壁观察液面，毛细吸管充满液体时采样完毕。In order to facilitate sampling, in the embodiment of the invention, the collecting
为实现准确定量采样，本发明实施例中，采集装置1的形状为前端毛细吸管后部管径迅速加大的前细后粗的漏斗结构，同时挤压装置3的后端
设置有孔状结构31。毛细吸管的内径和长度决定所吸取的液体体积，即采集量。当泪液样品充满采集装置1，即毛细吸管，虹吸毛细作用即停止。In order to achieve accurate quantitative sampling, in the embodiment of the present invention, the shape of the
在泪液采集器尽量短小方便握持的基础上，满足多层次的使用需求，实现精密定量的体积泪液的采集量，本发明实施例中，缓冲装置2的形状为前窄后宽的锥形结构。锥形结构的设计，不仅方便握持，而且体积小且圆润，方便使用的同时可以减轻患者的恐惧感。On the basis that the tear collector is as short as possible and convenient to hold, the multi-level use requirement is satisfied, and the precise and quantitative volume of tear collection is realized. In the embodiment of the invention, the shape of the
为了便于泪液采集后的排出，本发明实施例中，挤压装置3为弹性挤压装置。使用很小的力就可以实现泪液的排出，操作便捷。In order to facilitate the discharge after the tear collection, in the embodiment of the invention, the
为便于观察泪液的采集情况，本发明实施例中，采集装置1为透明采集装置，缓冲装置2为透明缓冲装置。In order to facilitate the observation of the collection of tears, in the embodiment of the present invention, the collecting
本发明还提供了一种包括以上任意一项的泪液采集器在体外诊断检测取样中的应用。上述仅提供了采集泪液的实施例，本领域技术人员可以清楚的得出，在不付出创造性劳动的前提下，本发明提供的一种泪液采集器可用于唾液、尿液、血液等各种体液的采集工作。The invention also provides the use of a tear collector comprising any of the above in in vitro diagnostic test sampling. The above only provides an embodiment for collecting tears, and those skilled in the art can clearly understand that the tear collector of the present invention can be used for various body fluids such as saliva, urine, blood, etc. without any creative labor. Collection work.
简而言之，本发明提供的一种泪液采集器，具有以下优点。第一，安全性：本发明提供的一种泪液采集器的结构更加圆润，使与患者接触的部位较为圆滑光整，正常操作下无创无痛，也不会对眼球眼表产生损害。第二，易操作性：本发明提供的一种泪液采集器根据人体工学原理设计，使采集器的长度、直径都适合手持和在眼表做精细操作。第三，采样快速简捷，本发明提供的一种泪液采集器设计应用了毛细管虹吸作用原理，采集装置为内外表面光滑圆整、内径细小的毛细管以及挤压装置的后端有孔状结构，泪液会迅速进入采集装置。第四，定量采样：利用采集装置的内径和长度精确控制吸入液体的体积，为定量分析泪液中生物标记物的浓度奠定良好基础。第五，采样送样一体化：泪液采集器采集液体后，通常需转运至合适的检验装置上(如金标卡等)或仪器设备中进行检验，本发明设计的泪液采集器本身自带具有弹性的可挤压后管，可将采集装置和暂存装置中的泪液吹出，实现采样送样一体化。第六，改善被检查者体验：采集器工业设计上圆润饱满，给患者以安全感；利用精细模具，制成与玻璃毛细吸管直径类似的采集头尖端，并不接触(或不明显刺激)眼表组织，实现无创无痛。 In short, the present invention provides a tear collector having the following advantages. First, safety: The tear collector of the present invention has a more rounded structure, so that the part in contact with the patient is smooth and smooth, and it is non-invasive and painless under normal operation, and does not cause damage to the ocular surface of the eye. Second, the operability: The tear collector of the present invention is designed according to the ergonomic principle, so that the length and diameter of the collector are suitable for hand-held and fine operation on the ocular surface. Thirdly, the sampling is quick and simple. The tear collector design provided by the present invention applies the principle of capillary siphon action, and the collecting device is a smooth and round inner and outer surface capillary tube with a small inner diameter and a hole-like structure at the rear end of the pressing device, tear liquid Will quickly enter the collection device. Fourth, quantitative sampling: the volume of the inhaled liquid is precisely controlled by the inner diameter and length of the collecting device, which lays a good foundation for quantitative analysis of the concentration of biomarkers in tears. Fifth, sampling and sample integration: After collecting the liquid, the tear collector usually needs to be transported to a suitable inspection device (such as a gold standard card) or equipment for inspection. The tear collector of the present invention has its own The elastic squeezable rear tube can blow out the tears in the collecting device and the temporary storage device to realize the integration of sampling and sample feeding. Sixth, improve the experience of the inspected: the industrial design of the collector is round and full, giving the patient a sense of security; using a fine mold to make the tip of the collecting head similar to the diameter of the glass capillary straw, without touching (or not irritating) the eye Table organization, achieving non-invasive and painless.
通过以上描述可以清楚的看出，本发明提供的一种泪液采集器，解决了现有技术中，泪液采集器主要存在着采样便捷性和定量取样之间不可同时兼顾的技术缺陷。同时，在临床应用和产业应用方面，都具有重大意义。在临床应用价值方面，作为眼科唯一无创可取的体液类生物样品，眼表泪液中含有大量因子和蛋白，与疾病的发生发展和分子机制关系密切，但是因为市场上或临床上尚没有方便、安全、有效的泪液采集装置或方法，泪液样品的采集和分析仅限于少数专业科研人员和科研性质，这是一直缺乏检测泪液的体外诊断试剂的关键原因之一，各种生物化学、蛋白质分析检测技术或免疫检测方法都未能应用于眼科疾病的诊断上。本发明提供的一种泪液采集器，具有方便、安全、有效的优点。同时，泪液中的各种活性因子、蛋白因子和生物标记物的存在与否或其浓度，反应了眼表的健康和病理状态。采集特定疾病患者的泪液后，对其成分、某个生物标记物因子或蛋白因子进行测量分析，有利于研究该疾病的分子病理机制。通过获取泪液进行检测，对眼科疾病，尤其是眼表疾病的诊断、鉴别诊断、随访、疗效判断以及预后预测有重要意义。在产业应用价值方面，与现有技术方案相比，即玻璃毛细吸管和吸水性材料相比，本发明提供的一种泪液采集器在可定量、精密度、准确性、易操作性、方便性及用户体验度方面，都有显著的提升，将为临床泪液采集提供了可能性和实用性，推动泪液相关检测技术的发展和眼科体外诊断试剂产品的开发和应用，增强眼科疾病精准诊断和治疗。It can be clearly seen from the above description that the tear collector of the present invention solves the technical defects in the prior art that the tear collector mainly has the convenience of sampling and quantitative sampling. At the same time, it has great significance in clinical application and industrial application. In terms of clinical application value, as the only non-invasive body fluid biological sample in ophthalmology, ocular surface tear contains a lot of factors and proteins, which are closely related to the occurrence and development of the disease and molecular mechanism, but it is not convenient or safe on the market or in clinical practice. Effective tear collection device or method, the collection and analysis of tear samples is limited to a few professional researchers and scientific research. This is one of the key reasons for the lack of in vitro diagnostic reagents for detecting tears. Various biochemical and protein analysis techniques Or immunoassay methods have not been applied to the diagnosis of ophthalmic diseases. The invention provides a tear collector which has the advantages of convenience, safety and effectiveness. At the same time, the presence or absence of various active factors, protein factors and biomarkers in the tears or their concentrations reflects the health and pathological state of the ocular surface. After collecting the tears of patients with specific diseases, the measurement and analysis of its components, a biomarker factor or protein factor is beneficial to study the molecular pathological mechanism of the disease. Detection of tears is important for the diagnosis, differential diagnosis, follow-up, efficacy judgment and prognosis of ophthalmic diseases, especially ocular surface diseases. In terms of industrial application value, compared with the prior art solution, that is, the glass capillary straw and the water absorbent material, the tear collector of the present invention can be quantitative, precise, accurate, easy to operate, and convenient. And user experience, there are significant improvements, will provide the possibility and practicality of clinical tear collection, promote the development of tear-related detection technology and the development and application of ophthalmic in vitro diagnostic reagent products, enhance the accurate diagnosis and treatment of ophthalmic diseases .
综上所述，本发明提供了一种泪液采集器，包括：采集装置1、缓冲装置2和挤压装置3；采集装置1的后端与缓冲装置的2前端连接，缓冲装置3的前端与暂存装置1的后端连接。。本发明提供的一种泪液采集器，利用采集装置1采集到泪液，当泪液到达采集装置1与缓冲装置2的连接处时，采样完毕，利用采集装置1采集到泪液之后，当需要对泪液进行检测时，可挤压挤压装置3，使得泪液排出泪液采集器。与玻璃毛细吸管相比，本发明提供的泪液采集器更好握持便于检测人员采样，同时，也可减轻患者的恐惧感。与吸水性材料相比，本发明提供的泪液采集器更容易对样品进行准确定量。解决了现有技术中，泪液采集器主要存在着采样便捷性和定量取样之间不可同时兼顾的技术缺陷。本发明还提供了上述的泪液
采集器在体外诊断检测取样中的应用。In summary, the present invention provides a tear collector, comprising: an
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。 The above description is only a preferred embodiment of the present invention, and it should be noted that those skilled in the art can also make several improvements and retouchings without departing from the principles of the present invention. It should be considered as the scope of protection of the present invention.
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| CN201610232017.9 | 2016-04-13 | ||
| CN201610232017.9A CN105675352A (en) | 2016-04-13 | 2016-04-13 | A tear collector |
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| US20210007720A1 (en) * | 2018-03-30 | 2021-01-14 | Provigate Inc. | Trace amount liquid sample collector |
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| CN105675352A (en) * | 2016-04-13 | 2016-06-15 | 广东盛泽康华生物医药有限公司 | A tear collector |
| CN106419831A (en) * | 2016-07-22 | 2017-02-22 | 广州市眼视光健康产业投资管理有限公司 | Body health monitoring glasses |
| CN108152087B (en) * | 2018-01-03 | 2023-04-14 | 沈阳何氏眼科医院有限公司 | Tear remote acquisition and analysis device and analysis method for diagnosing dry eyes |
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| CN109883769A (en) | 2019-06-14 |
| CN105675352A (en) | 2016-06-15 |
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