CN112219118B - Blood sampling container - Google Patents
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- CN112219118B CN112219118B CN201980037695.1A CN201980037695A CN112219118B CN 112219118 B CN112219118 B CN 112219118B CN 201980037695 A CN201980037695 A CN 201980037695A CN 112219118 B CN112219118 B CN 112219118B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
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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
- A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
- A61B5/154—Devices using pre-evacuated means
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
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Abstract
本发明提供即使采血后的采血容器暴露于低温环境的情况下,也能够防止底面部的龟裂或裂纹的采血容器。本发明的采血容器具备采血容器主体和栓体,所述采血容器主体具有开口端、侧面部和底面部,所述栓体插入所述开口端中,所述底面部的底端的厚度与所述侧面部的平均厚度之比为1.25以上1.75以下,所述采血容器主体的材料包含特性黏度为0.75dL/g以上0.79dL/g以下的聚对苯二甲酸乙二醇酯。
The present invention provides a blood collection container that can prevent cracks or cracks on the bottom surface even when the blood collection container is exposed to a low temperature environment after blood collection. The blood collection container of the present invention includes a blood collection container main body and a plug body. The blood collection container main body has an open end, a side part and a bottom part. The plug body is inserted into the open end. The thickness of the bottom end of the bottom part is equal to the thickness of the bottom part. The ratio of the average thickness of the side portion is 1.25 or more and 1.75 or less, and the material of the blood collection container body contains polyethylene terephthalate with an intrinsic viscosity of 0.75 dL/g or more and 0.79 dL/g or less.
Description
技术领域Technical field
本发明涉及采血容器。The present invention relates to blood collection containers.
背景技术Background technique
在临床检查中,采血管等采血容器被广泛用于采集血液。此外,通过使用内部容纳有血清或血浆分离用组合物的采血容器,而能够将血清或血浆从采集的血液(全血)中分离。In clinical examinations, blood collection containers such as blood collection tubes are widely used to collect blood. Furthermore, serum or plasma can be separated from collected blood (whole blood) by using a blood collection container containing a serum or plasma separation composition inside.
作为采血容器的一个实例,下述的专利文献1中公开了具备管主体、片材和止血阀的采血容器,所述管主体具有开口了的第1端,所述片材与所述管主体的第1端接合并堵塞所述开口,所述止血阀可以通过弹性变形在管主体的长度方向开口。就所述止血阀而言,在所述管主体内,以对于该管主体的长度方向而分隔所述第1端侧和相反侧的方式进行配置。As an example of a blood collection container, the following Patent Document 1 discloses a blood collection container including a tube main body having an open first end, a sheet, and a hemostatic valve. The first end engages and blocks the opening, and the hemostatic valve can open in the length direction of the tube body through elastic deformation. The hemostatic valve is arranged in the tube body so as to separate the first end side and the opposite side with respect to the longitudinal direction of the tube body.
现有技术文献existing technical documents
专利文献patent documents
专利文献1:日本特开2010-154909号公报Patent Document 1: Japanese Patent Application Publication No. 2010-154909
发明内容Contents of the invention
发明所解决的技术问题The technical problem solved by the invention
采血后的采血容器存在下述情况:在进行了用于从血液中分离血清或血浆的离心分离后,通过将干冰等置于该采血容器的上部,而在低温环境下(例如-20℃以下)进行保管或输送。在这种情况下,由于干冰等的影响,而从位于采血容器上方的血清或血浆等源自血液的样品开始冷冻。The blood collection container after blood collection may be in a low-temperature environment (for example, -20°C or lower) by placing dry ice or the like on the upper part of the blood collection container after performing centrifugal separation to separate serum or plasma from blood. ) for storage or transportation. In this case, the blood-derived sample such as serum or plasma located above the blood collection container is frozen due to the influence of dry ice or the like.
由于血清和血浆等源自血液的样品包含大量水分,因此,当冷冻所述源自血液的样品时,与冷冻前相比,体积增加。因此,当通过所述方法保管采血容器等时,首先将位于采血容器上方的源自血液的样品冷冻,从而抑制位于采血容器下方的源自血液的样品的冷冻膨胀,力施加至采血容器的底面部。Since blood-derived samples such as serum and plasma contain a large amount of water, when the blood-derived samples are frozen, the volume increases compared to before freezing. Therefore, when a blood collection container or the like is stored by the above method, the blood-derived sample located above the blood collection container is first frozen, thereby suppressing the freezing expansion of the blood-derived sample located below the blood collection container, and a force is applied to the bottom surface of the blood collection container department.
在专利文献1所述的以往的采血容器中,存在下述情况:采血容器主体的底面部的强度较低,在通过所述方法冷冻的情况下,由于源自血液的样品的冷冻膨胀,而使该底面部产生龟裂或裂纹。In the conventional blood collection container described in Patent Document 1, the strength of the bottom portion of the blood collection container body is low, and when frozen by the above method, the sample derived from blood may expand due to freezing. This causes cracks or cracks to occur on the bottom surface.
本发明的目的是提供,即使采血后的采血容器暴露于低温环境的情况下,也能够防止底面部的龟裂或裂纹的采血容器。An object of the present invention is to provide a blood collection container that can prevent cracks or cracks on the bottom surface even when the blood collection container is exposed to a low temperature environment after blood collection.
解决问题的技术手段Technical means to solve problems
根据本发明的广泛方案,提供采血容器,其具备采血容器主体和栓体,所述采血容器主体具有开口端、侧面部和底面部,所述栓体插入所述开口端中,所述底面部的底端的厚度与所述侧面部的平均厚度之比为1.25以上1.75以下,采血容器主体的材料包含特性黏度为0.75dL/g以上0.79dL/g以下的聚对苯二甲酸乙二醇酯。According to a broad aspect of the present invention, a blood collection container is provided, which is provided with a blood collection container main body and a plug body. The blood collection container main body has an open end, a side part, and a bottom part. The plug body is inserted into the open end, and the bottom part is The ratio of the thickness of the bottom end to the average thickness of the side portion is 1.25 or more and 1.75 or less, and the material of the blood collection container body contains polyethylene terephthalate with an intrinsic viscosity of 0.75 dL/g or more and 0.79 dL/g or less.
在本发明的采血容器的一个特定方案中,所述底面部的底端的厚度为1.25mm以上1.75mm以下。In a specific aspect of the blood collection container of the present invention, the thickness of the bottom end of the bottom portion is 1.25 mm or more and 1.75 mm or less.
在本发明的采血容器的其他特定方案中,所述采血容器具备血清或血浆分离用组合物,所述血清或血浆分离用组合物容纳于所述采血容器主体中。In another specific aspect of the blood collection container of the present invention, the blood collection container is provided with a serum or plasma separation composition, and the serum or plasma separation composition is accommodated in the blood collection container main body.
在本发明的采血容器的又一特定方案中,所述采血容器具备血凝块剥离剂,所述血凝块剥离剂附着于所述采血容器主体的内壁面上。In another specific aspect of the blood collection container of the present invention, the blood collection container is provided with a blood clot stripping agent, and the blood clot stripping agent is attached to the inner wall surface of the blood collection container main body.
发明效果Invention effect
本发明的采血容器具备采血容器主体和栓体,所述采血容器主体具有开口端、侧面部和底面部,所述栓体插入所述开口端中。在本发明的采血容器的情况下,所述底面部的底端的厚度与所述侧面部的平均厚度之比为1.25以上1.75以下。在本发明的采血容器的情况下,所述采血容器主体的材料包含特性黏度为0.75dL/g以上0.79dL/g以下的聚对苯二甲酸乙二醇酯。在本发明的采血容器的情况下,由于具备所述构成,因此,即使采血后的采血容器暴露于低温环境的情况下,也能够防止底面部的龟裂或裂纹。The blood collection container of the present invention includes a blood collection container main body having an open end, a side surface and a bottom surface, and a plug body inserted into the open end. In the blood collection container of the present invention, the ratio of the thickness of the bottom end of the bottom portion to the average thickness of the side portion is 1.25 or more and 1.75 or less. In the case of the blood collection container of the present invention, the material of the blood collection container body contains polyethylene terephthalate with an intrinsic viscosity of 0.75 dL/g or more and 0.79 dL/g or less. In the case of the blood collection container of the present invention, since it has the above-mentioned structure, even when the blood collection container is exposed to a low-temperature environment after blood collection, it is possible to prevent cracks or cracks on the bottom surface.
附图说明Description of the drawings
图1是本发明的一个实施方式的采血容器主体的正视截面图。FIG. 1 is a front cross-sectional view of the main body of the blood collection container according to one embodiment of the present invention.
图2(a)和(b)是本发明的一个实施方式的栓体的正视图和正视截面图。2(a) and (b) are a front view and a front cross-sectional view of the plug body according to one embodiment of the present invention.
图3是本发明的一个实施方式的采血容器的正视截面图。3 is a front cross-sectional view of the blood collection container according to one embodiment of the present invention.
具体实施方式Detailed ways
以下,对本发明详细地进行说明。Hereinafter, the present invention will be described in detail.
本发明的采血容器具备采血容器主体和栓体,所述采血容器主体具有开口端、侧面部和底面部,所述栓体插入所述开口端中。在本发明的采血容器的情况下,所述底面部的底端的厚度与所述侧面部的平均厚度之比为1.25以上1.75以下。在本发明的采血容器的情况下,所述采血容器主体的材料包含特性黏度为0.75dL/g以上0.79dL/g以下的聚对苯二甲酸乙二醇酯。The blood collection container of the present invention includes a blood collection container main body having an open end, a side surface and a bottom surface, and a plug body inserted into the open end. In the blood collection container of the present invention, the ratio of the thickness of the bottom end of the bottom portion to the average thickness of the side portion is 1.25 or more and 1.75 or less. In the case of the blood collection container of the present invention, the material of the blood collection container body contains polyethylene terephthalate with an intrinsic viscosity of 0.75 dL/g or more and 0.79 dL/g or less.
在本发明的采血容器的情况下,由于具备所述构成,因此,即使采血后的采血容器暴露于低温环境的情况下,也能够防止底面部的龟裂或裂纹。In the case of the blood collection container of the present invention, since it has the above-mentioned structure, even when the blood collection container is exposed to a low-temperature environment after blood collection, it is possible to prevent cracks or cracks on the bottom surface.
此外,在本发明的采血容器的情况下,还能够防止侧面部的龟裂或裂纹。In addition, in the case of the blood collection container of the present invention, it is possible to prevent cracks or cracks in the side portion.
通常,采血容器主体的底面部具有圆形形状。例如,就采血容器的底面部的外形而言,当从正面观察采血容器主体时,为圆弧状或椭圆弧状。在以往的采血容器的情况下,为了提高采血容器主体的成形性,而使用特性黏度小的树脂(例如,特性黏度为0.6dL/g左右的聚对苯二甲酸乙二醇酯)作为采血容器主体的材料。此外,在以往的采血容器的情况下,采血容器主体的侧面部的厚度与底面部的厚度大致相同。因此,在以往的采血容器的情况下,存在下述情况:采血容器主体的底面部的强度较低,由于源自血液的样品的冷冻膨胀,而使该底面部产生龟裂或裂纹。Generally, the bottom portion of the blood collection container body has a circular shape. For example, the shape of the bottom portion of the blood collection container is a circular arc shape or an elliptical arc shape when the blood collection container body is viewed from the front. In the case of conventional blood collection containers, in order to improve the formability of the blood collection container body, a resin with a low intrinsic viscosity (for example, polyethylene terephthalate with an intrinsic viscosity of about 0.6 dL/g) is used as the blood collection container. The material of the subject. In addition, in the case of the conventional blood collection container, the thickness of the side portion of the blood collection container body is substantially the same as the thickness of the bottom portion. Therefore, in the case of conventional blood collection containers, the strength of the bottom portion of the blood collection container body is low, and cracks or cracks may occur in the bottom portion due to freezing expansion of the blood-derived sample.
与之相对,在本发明的采血容器的情况下,由于作为采血容器主体的材料而使用了包含具有特定的特性黏度的聚对苯二甲酸乙二醇酯的材料,并且采血容器主体具有特定形状,因此,能够提高底面部的强度。因此,即使在将干冰等置于为了从血液中分离血清或血浆而进行了离心分离的采血容器的上部而将采血容器暴露于低温环境(例如-20℃以下)的情况下,也能够防止底面部的龟裂或裂纹。In contrast, in the case of the blood collection container of the present invention, a material containing polyethylene terephthalate having a specific intrinsic viscosity is used as the material of the blood collection container body, and the blood collection container body has a specific shape. , therefore, the strength of the bottom portion can be improved. Therefore, even when dry ice or the like is placed on the upper part of a blood collection container that has been centrifuged to separate serum or plasma from blood and the blood collection container is exposed to a low temperature environment (for example, -20° C. or lower), it is possible to prevent the bottom surface from being Internal cracks or cracks.
在本发明中,为了提高采血容器主体的底面部的强度,没有整体增加采血容器主体的厚度(侧面部的厚度和底面部的厚度),而是使底面部的厚度与侧面部的厚度之比相对增大。因此,可以在通常使用的自动分析装置的输送装置中使用,此外,与采血容器主体整体的厚度增加的采血容器相比,能够降低制造成本。In the present invention, in order to improve the strength of the bottom portion of the blood collection container body, the thickness of the blood collection container body (thickness of the side portion and the thickness of the bottom portion) is not increased as a whole, but the ratio of the thickness of the bottom portion to the thickness of the side portion is relatively increased. Therefore, it can be used in a transport device of a commonly used automatic analyzer, and the manufacturing cost can be reduced compared to a blood collection container in which the thickness of the entire blood collection container body is increased.
以下,参照附图,对本发明的具体实施方式进行说明。Hereinafter, specific embodiments of the present invention will be described with reference to the drawings.
图1是本发明的一个实施方式的采血容器主体的正视截面图。FIG. 1 is a front cross-sectional view of the main body of the blood collection container according to one embodiment of the present invention.
采血容器主体1具有开口端1a、侧面部1b和底面部1c。采血容器主体1的一端开口,与这一端相反的另一端封闭。侧面部1b与底面部1c连接。采血容器主体1在一端具有开口端1a,在另一端具有底面部1c的底端11c。The blood collection container main body 1 has an open end 1a, a side surface 1b, and a bottom surface 1c. One end of the blood collection container body 1 is open, and the other end opposite to this end is closed. The side part 1b is connected to the bottom part 1c. The blood collection container main body 1 has an open end 1a at one end and a bottom end 11c with a bottom surface 1c at the other end.
底面部1c具有圆形形状。就底面部1c的外形而言,当从正面观察采血容器主体1时,为圆弧状或椭圆弧状。就侧面部1b的外形而言,当从正面观察采血容器主体1时,不是圆弧状和椭圆弧状。通过对底面部的外形形状和侧面部的外形形状进行观察,而能够区别底面部与侧面部。The bottom portion 1c has a circular shape. The outer shape of the bottom portion 1 c is in the shape of a circular arc or an elliptical arc when the blood collection container body 1 is viewed from the front. The outer shape of the side portion 1 b is not in the shape of a circular arc or an elliptical arc when the blood collection container body 1 is viewed from the front. By observing the outer shape of the bottom portion and the outer shape of the side portion, the bottom portion and the side portion can be distinguished.
采血容器主体1的底面部1c的底端11c的厚度与侧面部1b的平均厚度之比(底面部1c的底端11c的厚度/侧面部1b的平均厚度)为1.25以上1.75以下。当所述比(底面部1c的底端11c的厚度/侧面部1b的平均厚度)小于1.25时,底面部的强度可能较差,在采血后的采血容器暴露于低温环境的情况下,可能产生底面部的龟裂或裂纹。当所述比(底面部1c的底端11c的厚度/侧面部1b的平均厚度)大于1.75时,可能在成形时产生凹痕。The ratio of the thickness of the bottom end 11c of the bottom portion 1c of the blood collection container body 1 to the average thickness of the side portion 1b (thickness of the bottom end 11c of the bottom portion 1c/average thickness of the side portion 1b) is 1.25 or more and 1.75 or less. When the ratio (thickness of the bottom end 11c of the bottom portion 1c/average thickness of the side portion 1b) is less than 1.25, the strength of the bottom portion may be poor, and when the blood collection container is exposed to a low temperature environment after blood collection, it may cause Cracks or cracks on the underside. When the ratio (thickness of bottom end 11c of bottom portion 1c/average thickness of side portion 1b) is greater than 1.75, dents may be generated during molding.
底面部1c的底端11c的厚度与侧面部1b的平均厚度之比(底面部1c的底端11c的厚度/侧面部1b的平均厚度)优选为1.3以上,优选为1.6以下。当所述比(底面部1c的底端11c的厚度/侧面部1b的平均厚度)为所述下限以上时,能够进一步提高底面部的强度,即使在采血后的采血容器暴露于低温环境的情况下,也能够进一步有效地防止底面部的龟裂或裂纹。当所述比(底面部1c的底端11c的厚度/侧面部1b的平均厚度)为所述上限以下时,能够减少成形不良。The ratio of the thickness of the bottom end 11c of the bottom portion 1c to the average thickness of the side portion 1b (thickness of the bottom end 11c of the bottom portion 1c/average thickness of the side portion 1b) is preferably 1.3 or more, and preferably 1.6 or less. When the ratio (thickness of the bottom end 11c of the bottom portion 1c/average thickness of the side portion 1b) is more than the lower limit, the strength of the bottom portion can be further improved even when the blood collection container after blood collection is exposed to a low temperature environment. It can also further effectively prevent cracks or cracks on the bottom surface. When the ratio (thickness of the bottom end 11c of the bottom portion 1c/average thickness of the side portion 1b) is equal to or less than the upper limit, molding defects can be reduced.
就所述侧面部的平均厚度而言,通过求出采血容器主体从开口端向底面部低10mm的位置起以10mm间隔选择的5处以上的位点的侧面部的厚度,将各位点的厚度进行平均而求得。The average thickness of the side portion is determined by determining the thickness of the side portion at five or more locations selected at 10 mm intervals from the opening end of the blood collection container body 10 mm lower than the bottom portion, and then the thickness at each location is calculated. Obtained by averaging.
侧面部1b的平均厚度优选为0.8mm以上,更优选为0.9mm以上,优选为1.5mm以下,更优选为1.3mm以下。当侧面部1b的平均厚度为所述下限以上和所述上限以下时,能够进一步提高采血容器主体的强度。The average thickness of the side part 1b is preferably 0.8 mm or more, more preferably 0.9 mm or more, preferably 1.5 mm or less, more preferably 1.3 mm or less. When the average thickness of the side portion 1 b is not less than the lower limit and not more than the upper limit, the strength of the blood collection container body can be further improved.
底面部1c的底端11c的厚度优选为1.25mm以上,更优选为1.3mm以上,优选为1.75mm以下,更优选为1.6mm以下。当底面部1c的底端11c的厚度为所述下限以上和所述上限以下时,能够进一步提高底面部的强度,即使在采血后的采血容器暴露于低温环境的情况下,也能够进一步有效地防止底面部的龟裂或裂纹。The thickness of the bottom end 11c of the bottom portion 1c is preferably 1.25 mm or more, more preferably 1.3 mm or more, preferably 1.75 mm or less, and more preferably 1.6 mm or less. When the thickness of the bottom end 11c of the bottom portion 1c is more than the lower limit and less than the upper limit, the strength of the bottom portion can be further improved, and even when the blood collection container after blood collection is exposed to a low temperature environment, it can be more effectively Prevent cracks or cracks on the bottom surface.
就侧面部1b而言,从开口端侧到底面部侧,可以向内侧倾斜,也可以不倾斜。The side portion 1b may or may not be inclined inward from the opening end side to the bottom portion side.
采血容器主体1的材料包含特性黏度为0.75dL/g以上0.79dL/g以下的聚对苯二甲酸乙二醇酯。当所述特性黏度小于0.75dL/g或大于0.79dL/g时,采血容器主体的成形性较差,可能无法成形为具有特定形状的底面部。需要说明的是,采血容器主体1的材料可以仅使用1种,也可以组合使用2种以上。The material of the blood collection container main body 1 includes polyethylene terephthalate with an intrinsic viscosity of not less than 0.75 dL/g and not more than 0.79 dL/g. When the intrinsic viscosity is less than 0.75 dL/g or greater than 0.79 dL/g, the blood collection container body has poor formability and may not be able to be formed into a bottom portion with a specific shape. It should be noted that only one type of material may be used for the blood collection container main body 1, or two or more types may be used in combination.
所述聚对苯二甲酸乙二醇酯的特性黏度优选为0.76dL/g以上,更优选为0.78dL/g以下。当所述聚对苯二甲酸乙二醇酯的特性黏度为所述下限以上和所述上限以下时,能够进一步提高成形性,能够进一步良好地使底面部成形。The intrinsic viscosity of the polyethylene terephthalate is preferably 0.76 dL/g or more, and more preferably 0.78 dL/g or less. When the intrinsic viscosity of the polyethylene terephthalate is not less than the lower limit and not more than the upper limit, the formability can be further improved, and the bottom portion can be formed more favorably.
所述特性黏度基于JIS K7390:2003求得。The intrinsic viscosity is determined based on JIS K7390:2003.
就采血容器主体1的材料而言,例如可以包含所述特性黏度为0.75dL/g以上0.79dL/g以下的聚对苯二甲酸乙二醇酯以外的聚酯等。The material of the blood collection container main body 1 may include, for example, polyester other than polyethylene terephthalate having the intrinsic viscosity of 0.75 dL/g or more and 0.79 dL/g or less.
在采血容器主体的材料100重量%中,所述特性黏度为0.75dL/g以上0.79dL/g以下的聚对苯二甲酸乙二醇酯的含量优选为85重量%以上,更优选为90重量%以上,进一步优选为95重量%以上,特别优选为99重量%以上,最优选为100重量%(总量)。因此,采血容器主体的材料最优选为所述特性黏度为0.75dL/g以上0.79dL/g以下的聚对苯二甲酸乙二醇酯。In 100% by weight of the material of the main body of the blood collection container, the content of polyethylene terephthalate with an intrinsic viscosity of 0.75 dL/g or more and 0.79 dL/g or less is preferably 85% by weight or more, and more preferably 90% by weight. % or more, more preferably 95 wt% or more, particularly preferably 99 wt% or more, most preferably 100 wt% (total). Therefore, the material of the main body of the blood collection container is most preferably polyethylene terephthalate having an intrinsic viscosity of 0.75 dL/g or more and 0.79 dL/g or less.
图2(a)是本发明的一个实施方式的栓体的正视图。图2(b)是本发明的一个实施方式的栓体的正视截面图。Fig. 2(a) is a front view of the plug body according to one embodiment of the present invention. Fig. 2(b) is a front cross-sectional view of the plug body according to one embodiment of the present invention.
栓体2具备盖部件21和栓主体22。盖部件21以覆盖栓主体22的外表面的方式进行外装。栓主体22的外表面与盖部件21的内表面接触。The plug body 2 includes a cover member 21 and a plug main body 22 . The cover member 21 is externally installed so as to cover the outer surface of the plug main body 22 . The outer surface of the plug body 22 is in contact with the inner surface of the cover member 21 .
就盖部件21而言,在盖部件的直径方向外侧具有多个突出的肋21a。盖部件可以具备肋,也可以不具备。从在血液采集后易于将栓体从采血容器主体取下或者防止盖部件、栓体和采血容器的滚动等提高盖部件、栓体和采血容器的操作性的观点出发,优选盖部件具备肋。The cover member 21 has a plurality of protruding ribs 21a on the outer side in the diameter direction of the cover member. The cover member may or may not have ribs. It is preferable that the cover member has ribs from the viewpoint of improving the operability of the cover member, the stopper body, and the blood collection container, such as making it easy to remove the embolus body from the blood collection container body after blood collection or preventing the cover member, the embolus body, and the blood collection container from rolling.
栓主体22在上端侧具有大径部,在下端侧具有小径部。栓主体22通过大径部和小径部而形成台阶。The plug main body 22 has a large diameter part on the upper end side and a small diameter part on the lower end side. The plug main body 22 forms a step by a large diameter part and a small diameter part.
优选栓主体22的材料是弹性体。所述栓主体22的材料可以仅使用1种,也可以组合使用2种以上。Preferably, the material of the plug body 22 is elastomer. Only one type of material may be used for the plug main body 22, or two or more types may be used in combination.
作为所述弹性体,可举出热固化性弹性体和热塑性弹性体等。作为所述热固化性弹性体,可举出:异戊二烯橡胶、丁基橡胶、丁二烯橡胶和苯乙烯-丁二烯共聚合橡胶等。作为所述热塑性弹性体,可举出苯乙烯类弹性体等。Examples of the elastomer include thermosetting elastomers, thermoplastic elastomers, and the like. Examples of the thermosetting elastomer include isoprene rubber, butyl rubber, butadiene rubber, styrene-butadiene copolymer rubber, and the like. Examples of the thermoplastic elastomer include styrenic elastomers.
在栓主体22的材料为所述弹性体的情况下,所述栓主体22为橡胶栓。优选所述栓主体22为橡胶栓。当栓主体为橡胶栓时,由于栓主体能够良好地变形,因此,能够有效地抑制栓主体从盖部件脱落。When the material of the plug body 22 is the elastomer, the plug body 22 is a rubber plug. Preferably, the plug body 22 is a rubber plug. When the plug body is a rubber plug, since the plug body can be deformed well, the plug body can be effectively suppressed from falling off the cover member.
从不考虑采血容器的尺寸而能够使用盖部件的观点出发,盖部件21的最大内径优选为12mm以上,更优选为13mm以上,优选为18mm以下,更优选为17mm以下。From the viewpoint that the cap member can be used regardless of the size of the blood collection container, the maximum inner diameter of the cap member 21 is preferably 12 mm or more, more preferably 13 mm or more, preferably 18 mm or less, and more preferably 17 mm or less.
从使盖部件的操作性良好的观点出发,盖部件21的长度优选为11mm以上,更优选为15mm以上,优选为25mm以下,更优选为20mm以下。From the viewpoint of improving the operability of the cover member, the length of the cover member 21 is preferably 11 mm or more, more preferably 15 mm or more, preferably 25 mm or less, and more preferably 20 mm or less.
图3是本发明的一个实施方式的采血容器的正视截面图。3 is a front cross-sectional view of the blood collection container according to one embodiment of the present invention.
采血容器4具备图1所示的采血容器主体1、图2所示的栓体2和血清或血浆分离用组合物3。栓体2插入采血容器主体1的开口端1a中。栓主体22的小径部插入采血容器主体1中。栓主体22的所述台阶部分与采血容器主体1的上端相接。血清或血浆分离用组合物3容纳于采血容器主体1中。The blood collection container 4 includes the blood collection container main body 1 shown in FIG. 1 , the embolus 2 shown in FIG. 2 , and the serum or plasma separation composition 3 . The plug body 2 is inserted into the open end 1a of the blood collection container body 1. The small diameter portion of the stopper main body 22 is inserted into the blood collection container main body 1 . The step portion of the plug body 22 is connected to the upper end of the blood collection container body 1 . The serum or plasma separation composition 3 is accommodated in the blood collection container main body 1 .
本发明的采血容器优选具备血清或血浆分离用组合物。The blood collection container of the present invention preferably includes a serum or plasma separation composition.
所述血清或血浆分离用组合物用于从血液中分离血清或血浆。The composition for separating serum or plasma is used to separate serum or plasma from blood.
当从血液中分离血清时,将血液采集至容纳有血清或血浆分离用组合物的采血容器的内部后,通过离心分离装置进行离心分离。通过离心分离,而使血液中的细胞成分和血液凝固成分等沉淀在下方(血凝块),使血清分离至上清液中。此时,所述血清或血浆分离用组合物位于这些的中间层,形成隔离血凝块与血清的分隔壁。When serum is separated from blood, blood is collected into a blood collection container containing serum or a plasma separation composition, and then centrifugally separated using a centrifugal separation device. By centrifugation, cellular components and blood coagulation components in the blood are precipitated below (blood clot), and the serum is separated into the supernatant. At this time, the serum or plasma separation composition is located in the middle layer, forming a partition wall that isolates the blood clot and serum.
作为所述血清或血浆分离用组合物,可以使用以往公知的血清或血浆分离用组合物。作为所述血清或血浆分离用组合物,例如可举出WO2011/105151A1等中所述的血清或血浆分离用组合物。As the serum or plasma separation composition, conventionally known serum or plasma separation compositions can be used. Examples of the serum or plasma separation composition include the serum or plasma separation composition described in WO2011/105151A1 and the like.
本发明的采血容器优选具备血凝块剥离剂。在采血容器4具备血凝块剥离剂的情况下,优选该血凝块剥离剂附着在采血容器主体1的内壁面上。通过使采血容器4具备所述血凝块剥离剂,而能够防止血液凝固后,血凝块附着在采血容器主体1的内壁面,能够良好地分离血凝块和血清。The blood collection container of the present invention preferably includes a blood clot removing agent. When the blood collection container 4 is equipped with a blood clot release agent, it is preferable that the blood clot release agent adheres to the inner wall surface of the blood collection container body 1 . By equipping the blood collection container 4 with the blood clot release agent, it is possible to prevent the blood clot from adhering to the inner wall surface of the blood collection container body 1 after blood coagulation, and to effectively separate the blood clot and serum.
作为所述血凝块剥离剂,可以使用以往公知的血凝块剥离剂。作为所述血凝块剥离剂,例如可举出日本特开2008-304207号公报和日本特公平5-10095号公报等中所述的血凝块剥离剂。As the blood clot-releasing agent, conventionally known blood clot-releasing agents can be used. Examples of the blood clot releasing agent include those described in Japanese Patent Application Publication No. 2008-304207 and Japanese Patent Application Publication No. 5-10095, etc.
以下,对所述采血容器的其它详细内容进行说明。Other details of the blood collection container will be described below.
所述采血容器的内压没有特别限定。所述采血容器可以是在内部被排气后,通过所述栓体得到了密封的真空采血容器(真空采血管)。在所述采血容器为真空采血管的情况下,能够忽略采血者的技术差异而简便地进行一定量的血液采集。The internal pressure of the blood collection container is not particularly limited. The blood collection container may be a vacuum blood collection container (vacuum blood collection tube) that is sealed by the plug body after the interior is exhausted. When the blood collection container is a vacuum blood collection tube, a certain amount of blood can be easily collected regardless of the skill difference of the blood collector.
从防止细菌感染的观点出发,优选所述采血容器的内部根据ISO和JIS所述的基准进行灭菌。From the viewpoint of preventing bacterial infection, it is preferable that the inside of the blood collection container is sterilized in accordance with standards described in ISO and JIS.
所述采血容器可以具备血液促凝剂,或根据抗血液凝固等目的而进一步具备二氧化硅和凝血酶等血液促凝剂以及肝素、乙二胺四乙酸(EDTA)和柠檬酸等抗凝剂等公知的药剂。例如,可以将所述药剂附着在所述采血容器主体的内壁上。The blood collection container may be equipped with a blood coagulant, or may be further equipped with blood accelerators such as silica and thrombin, and anticoagulants such as heparin, ethylenediaminetetraacetic acid (EDTA), and citric acid for purposes such as anti-blood coagulation. and other well-known pharmaceuticals. For example, the medicament can be attached to the inner wall of the main body of the blood collection container.
采血容器主体可以通过将采血容器主体的材料注入与该采血容器主体的形状对应的金属模具中,进行成形而制备。根据需要,可以将血凝块剥离剂附着在得到的采血容器主体的内壁面上,并且,将血清或血浆分离用组合物容纳于得到的采血容器主体中,将栓体插入采血容器主体的开口端中,制备采血容器。The blood collection container main body can be prepared by injecting the material of the blood collection container main body into a metal mold corresponding to the shape of the blood collection container main body, and shaping the material. If necessary, a blood clot stripping agent can be adhered to the inner wall surface of the obtained blood collection container body, the serum or plasma separation composition is accommodated in the obtained blood collection container body, and the plug is inserted into the opening of the blood collection container body. Put it in the middle and prepare the blood collection container.
当将血液采集至所述采血容器内时,准备所述采血容器和具备采血针的采血架,进行以下的工序1)-3)。工序1)将采血针的一端的针尖插入血管。工序2)以使采血针的另一端的针尖贯穿采血容器的栓体的方式,将采血容器插入采血架。工序3)由于采血容器内部进行了减压,因此,血液通过采血针而被吸入采血容器内。When blood is collected into the blood collection container, the blood collection container and the blood collection rack equipped with the blood collection needle are prepared, and the following steps 1) to 3) are performed. Step 1) Insert the tip of one end of the blood collection needle into the blood vessel. Step 2) Insert the blood collection container into the blood collection rack such that the tip of the other end of the blood collection needle penetrates the plug body of the blood collection container. Step 3) Since the inside of the blood collection container is depressurized, blood is sucked into the blood collection container through the blood collection needle.
以下,举出实施例对本发明进行更详细说明。本发明不限于以下的实施例。Hereinafter, an Example is given and this invention is demonstrated in more detail. The present invention is not limited to the following examples.
准备以下的栓体。Prepare the following plug body.
具有图2所示的形状的栓体A plug body having the shape shown in Figure 2
栓主体:橡胶栓(材料:丁基橡胶)Plug body: rubber plug (material: butyl rubber)
盖部件:长度20mm,最大内径14mm,材料:聚乙烯Cover part: length 20mm, maximum inner diameter 14mm, material: polyethylene
通过以下的方式制备血清或血浆分离用组合物。A composition for serum or plasma separation is prepared in the following manner.
将环戊二烯类低聚物(EXXON MOBIL公司制,商品名:ESCOREZ5690)和偏苯三酸酯(大日本油墨化学工业公司制,商品名:MONOCIZER W700)在130℃下进行溶解,制备液态树脂成分。将聚丙二醇(NOF公司制,商品名:UNIOL D700)作为聚亚烷基二醇溶解在该液态树脂成分中,冷却至约30℃。接下来,作为无机粉末,将亲水性二氧化硅微粉(NIPPON AEROSIL公司制,商品名:AEROSIL 200CF)和疏水性二氧化硅微粉(NIPPON AEROSIL公司制,商品名:AEROSIL R974)添加在液态树脂成分中,用行星式混合机进行搅拌,同时使其分散。由此,制备血清或血浆分离用组合物。需要说明的是,就各成分的混合比例而言,相对于得到的血清或血浆分离用组合物100重量%,设为环戊二烯类低聚物52.3重量%、偏苯三酸酯44.2重量%、聚丙二醇0.8重量%、亲水性二氧化硅微粉1.0重量%、疏水性二氧化硅微粉1.7重量%。得到的血清或血浆分离用组合物在25℃下的比重为1.05。需要说明的是,比重通过浮选法测定。Cyclopentadiene oligomer (manufactured by EXXON MOBIL, trade name: ESCOREZ5690) and trimellitate (manufactured by Dainippon Ink Chemical Industries, Ltd., trade name: MONOCIZER W700) were dissolved at 130°C to prepare a liquid Resin composition. Polypropylene glycol (manufactured by NOF, trade name: UNIOL D700) as polyalkylene glycol was dissolved in the liquid resin component and cooled to about 30°C. Next, as inorganic powders, hydrophilic silica fine powder (manufactured by NIPPON AEROSIL Co., Ltd., trade name: AEROSIL 200CF) and hydrophobic silica fine powder (manufactured by NIPPON AEROSIL Co., Ltd., trade name: AEROSIL R974) were added to the liquid resin. Ingredients are stirred with a planetary mixer and dispersed at the same time. Thus, a composition for serum or plasma separation is prepared. In addition, the mixing ratio of each component was 52.3 weight% of cyclopentadiene oligomer and 44.2 weight% of trimellitic acid ester based on 100 weight% of the obtained serum or plasma separation composition. %, polypropylene glycol 0.8% by weight, hydrophilic silica powder 1.0% by weight, and hydrophobic silica powder 1.7% by weight. The obtained serum or plasma separation composition had a specific gravity of 1.05 at 25°C. It should be noted that the specific gravity is measured by the flotation method.
通过以下的方式制备含有二氧化硅(促凝剂)的血凝块剥离剂。A blood clot peeling agent containing silica (coagulant) was prepared in the following manner.
在甲醇中,添加将羟基导入聚二甲基硅氧烷而得到的甲醇改性硅油、聚乙烯吡咯烷酮和二氧化硅微粉(平均粒径40μm,亚麻籽油吸油量30ml/100g,BET比表面积12000cm2/g,电阻率26Ω·cm)。由此,制备含有二氧化硅的血凝块剥离剂。需要说明的是,就各成分的混合比例而言,相对于得到的含有二氧化硅的血凝块剥离剂100重量%,设为甲醇改性硅油0.1重量%、聚乙烯吡咯烷酮0.1重量%、二氧化硅微粉1.0重量%。To methanol, add methanol-modified silicone oil obtained by introducing hydroxyl groups into polydimethylsiloxane, polyvinylpyrrolidone and silica fine powder (average particle size 40 μm, linseed oil absorption capacity 30ml/100g, BET specific surface area 12000cm 2 /g, resistivity 26Ω·cm). Thus, a silica-containing blood clot release agent was prepared. In addition, the mixing ratio of each component was 0.1 wt% of methanol-modified silicone oil, 0.1 wt% of polyvinylpyrrolidone, and 0.1 wt% of polyvinyl pyrrolidone, based on 100 wt% of the obtained silica-containing blood clot release agent. Silica fine powder 1.0% by weight.
(实施例1)(Example 1)
采血容器主体的制备:Preparation of the main body of the blood collection container:
作为采血容器主体的材料,准备特性黏度0.77dL/g的聚对苯二甲酸乙二醇酯。将所述聚对苯二甲酸乙二醇酯注入金属模具中,在300℃的加热温度下进行成形,制备图1所示的形状的采血容器主体。得到的采血容器主体的尺寸如下所示。需要说明的是,聚对苯二甲酸乙二醇酯的特性黏度基于JIS K7390:2003求得。此外,就侧面部的平均厚度而言,通过求出采血容器主体从开口端向底面部低10mm的位置起以10mm间隔选择的5处以上的位点的侧面部的厚度,将各位点的厚度进行平均而求得。此外,在得到的采血容器主体中,底面部的底端以外的部分的厚度也大于侧面部的平均厚度。As a material for the main body of the blood collection container, polyethylene terephthalate with an intrinsic viscosity of 0.77 dL/g was prepared. The polyethylene terephthalate was injected into a metal mold and molded at a heating temperature of 300° C. to prepare a blood collection container main body having the shape shown in Figure 1 . The dimensions of the resulting blood collection container body are as follows. In addition, the intrinsic viscosity of polyethylene terephthalate was determined based on JIS K7390:2003. In addition, the average thickness of the side portion was determined by determining the thickness of the side portion of the blood collection container body at five or more locations selected at intervals of 10 mm from the opening end to the bottom portion 10 mm, and then the thickness at each location was calculated. Obtained by averaging. In addition, in the obtained blood collection container main body, the thickness of the portion other than the bottom end of the bottom portion is also greater than the average thickness of the side portion.
侧面部的平均厚度:1.0mm,侧面部的长度:93mmAverage thickness of side parts: 1.0mm, length of side parts: 93mm
底面部的底端的厚度:1.25mm,底面部的长度:7mmThe thickness of the bottom of the bottom part: 1.25mm, the length of the bottom part: 7mm
开口端的内径:11mmInner diameter of open end: 11mm
采血容器主体的长度:100mmLength of main body of blood collection container: 100mm
采血容器的制备:Preparation of blood collection containers:
将得到的含有二氧化硅的血凝块剥离剂喷涂在采血容器主体的内壁面上,进行风干。接着,将得到的血清或血浆分离用组合物0.9g容纳于采血容器主体内,将采血容器内部减压至12kPa,通过栓体进行密封并制备采血容器。需要说明的是,制备10根采血容器。The obtained blood clot stripping agent containing silica is sprayed on the inner wall surface of the blood collection container body and air-dried. Next, 0.9 g of the obtained serum or plasma separation composition was placed in the main body of the blood collection container, the pressure inside the blood collection container was reduced to 12 kPa, and the blood collection container was sealed with a plug to prepare a blood collection container. In addition, 10 blood collection containers were prepared.
(实施例2)(Example 2)
变更金属模具尺寸,将采血容器主体的底面部的底端的厚度设为1.5mm,除此之外,以与实施例1同样的方式,制备采血容器主体和采血容器。A blood collection container body and a blood collection container were prepared in the same manner as in Example 1 except that the size of the metal mold was changed and the thickness of the bottom end of the bottom portion of the blood collection container body was 1.5 mm.
(实施例3)(Example 3)
变更金属模具尺寸,将采血容器主体的底面部的底端的厚度设为1.75mm,除此之外,以与实施例1同样的方式,制备采血容器主体和采血容器。A blood collection container body and a blood collection container were prepared in the same manner as in Example 1 except that the size of the metal mold was changed and the thickness of the bottom end of the bottom portion of the blood collection container body was set to 1.75 mm.
(比较例1)(Comparative example 1)
使用特性黏度0.61dL/g的聚对苯二甲酸乙二醇酯作为采血容器主体的材料,变更金属模具尺寸,将采血容器主体的底面部的底端的厚度设为1.0mm,除此之外,以与实施例1同样的方式,制备采血容器主体和采血容器。需要说明的是,在得到的采血容器主体中,底面部的底端以外的部分的厚度与侧面部的平均厚度相同。Polyethylene terephthalate with an intrinsic viscosity of 0.61 dL/g was used as the material of the blood collection container body, and the size of the metal mold was changed so that the thickness of the bottom end of the bottom portion of the blood collection container body was 1.0 mm. In addition, In the same manner as in Example 1, a blood collection container main body and a blood collection container were prepared. In addition, in the obtained blood collection container main body, the thickness of the part other than the bottom end of the bottom part was the same as the average thickness of the side part.
(评价)(evaluate)
<低温环境下的底面部的龟裂或裂纹><Cracks or cracks on the bottom surface in low temperature environments>
将25℃下的比重调整为1.080的食盐水0.9g注入得到的采血容器的内部后,在1700G下进行5分钟的离心操作。通过进行离心操作,而使血清或血浆分离用组合物和食盐水分离,并且使血清或血浆分离用组合物(25℃下的比重1.05)位于上方,食盐水位于下方。接着,注入25℃下的比重为1.000的注射用水2.5mL。由此,制备从采血容器的底面部侧朝向开口端侧依次配置有食盐水、血清或血浆分离用组合物、注射用水的采血容器。After injecting 0.9 g of salt water adjusted to a specific gravity of 1.080 at 25° C. into the obtained blood collection container, centrifugation was performed at 1700 G for 5 minutes. The serum or plasma separation composition and saline are separated by performing a centrifugation operation so that the serum or plasma separation composition (specific gravity at 25°C: 1.05) is located above and the saline is located below. Next, 2.5 mL of water for injection with a specific gravity of 1.000 at 25°C was injected. Thus, a blood collection container is prepared in which saline solution, a composition for separating serum or plasma, and water for injection are arranged in this order from the bottom surface side toward the open end side of the blood collection container.
接下来,将该采血容器立在试管架上并使采血容器主体的底面部为下方,将干冰载置在采血容器的上端(栓体)上,收纳至发泡聚苯乙烯箱内。在将发泡聚苯乙烯箱内的温度保持在-40℃以下的状态下静置24小时。Next, the blood collection container is placed on a test tube rack with the bottom of the blood collection container body downward, dry ice is placed on the upper end (stopper) of the blood collection container, and the container is stored in an expanded polystyrene box. Let it stand for 24 hours while keeping the temperature in the expanded polystyrene box below -40°C.
静置后,将采血容器放置在室温下,进行解冻。然后,通过肉眼观察采血容器主体的底面部。求得10根采血容器中底面部产生龟裂或裂纹的根数。After standing, place the blood collection container at room temperature to thaw. Then, observe the bottom surface of the blood collection container body with the naked eye. Find the number of cracks or cracks on the bottom surface of 10 blood collection containers.
将采血容器的构成和结果示于下述表1。The structure and results of the blood collection container are shown in Table 1 below.
符号说明Symbol Description
1…采血容器主体1…blood collection container body
1a…开口端1a…open end
1b…侧面部1b…Side face
1c…底面部1c…bottom surface
2…栓体2…bolt body
3…血清或血浆分离用组合物3...Compositions for separation of serum or plasma
4…采血容器4…blood collection container
11c…底端11c…bottom
21…盖部件21…Cover parts
21a…肋21a…rib
22…栓主体22…bolt body
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