WO2023024434A1 - Disposable urine collection tube without need to be uncapped - Google Patents

Disposable urine collection tube without need to be uncapped Download PDF

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Publication number
WO2023024434A1
WO2023024434A1 PCT/CN2022/074408 CN2022074408W WO2023024434A1 WO 2023024434 A1 WO2023024434 A1 WO 2023024434A1 CN 2022074408 W CN2022074408 W CN 2022074408W WO 2023024434 A1 WO2023024434 A1 WO 2023024434A1
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WO
WIPO (PCT)
Prior art keywords
tube
collection tube
urine collection
opening
disposable urine
Prior art date
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PCT/CN2022/074408
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French (fr)
Chinese (zh)
Inventor
武楠
Original Assignee
上海蜚誉生物科技有限公司
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Publication date
Priority claimed from CN202121985998.7U external-priority patent/CN215833074U/en
Priority claimed from CN202123442803.7U external-priority patent/CN216955333U/en
Application filed by 上海蜚誉生物科技有限公司 filed Critical 上海蜚誉生物科技有限公司
Publication of WO2023024434A1 publication Critical patent/WO2023024434A1/en

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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/02Devices for withdrawing samples
    • G01N1/10Devices for withdrawing samples in the liquid or fluent state

Definitions

  • the present application relates to the technical field of medical testing, in particular to a disposable urine collection tube.
  • a disposable urine collection tube including a new type of diaphragm, which is easy to achieve the manufacturing process under the premise of ensuring the sealing performance.
  • a disposable urine collection tube that does not need to be opened is disclosed, including: a tube cover, a septum, and a tube body;
  • the diaphragm when the tube cover is connected with the tube body, the diaphragm is located between the tube body and the tube cover, thereby forming a closed space inside the tube body for containing the urine to be tested;
  • the septum is a membrane-like structure that is liquid-tight and allows the sampling needle to pass through, and has a pendant drop-like shape, and the pendant drop-like shape is selected from the following group: the septum is concave toward the bottom of the tube, or the septum is concave toward the bottom of the tube Nozzle convex;
  • the disposable urine collection tube without opening the cover is configured as follows: when sampling, the tube cover can be opened, the urine to be tested is loaded into the tube body and then the tube cover is covered, and the urine to be tested is collected. The liquid is sealed in the disposable urine collection tube; when the urine to be tested is detected, the detection sampling needle directly passes through the septum without opening the tube cover and passes through the urine to be tested. Take a urine sample.
  • the depth h1 of the depression (referring to the distance h1 between the lowest point of the depression and the plane surrounding the diaphragm) is ⁇ 2 mm, preferably ⁇ 3 mm, more preferably 2-6 mm.
  • the height h2 of the bulge (referring to the distance h2 between the highest point of the bulge and the plane around the diaphragm) is ⁇ 2 mm, preferably ⁇ 3 mm, more preferably 2-6 mm.
  • the septum is fixedly disposed on, attached to, or adhered to the cap.
  • the diaphragm has a thickness of t and a diameter of d, and the value range of t is 0.3 ⁇ t ⁇ 3mm; the value range of d is 8 ⁇ d ⁇ 25mm.
  • the cap-free disposable urine collection tube has a capacity of 5-20ml.
  • the tube cap and the tube body are detachably screwed together.
  • one or more stop protrusions are provided on the outer side of the tube cover along the circumference, for preventing the disposable urine collection tube from rolling freely when placed horizontally.
  • the membranous structure on the septum that allows the sampling needle to pass through is a non-penetrating notch.
  • the non-penetrating notch has one or more characteristics selected from the following group:
  • the ratio of the thickness of the non-penetrating notch to the thickness of the diaphragm ranges from 1% to 10%;
  • the non-penetrating notch is in the shape of a "ten” or a "Y".
  • the diaphragm is made of soft plastic material.
  • a plurality of reinforcing ribs are provided around the bottom of the nipple at the bottom of the tubular body.
  • the disposable urine collection tube is adapted to an automatic urine analyzer or an automatic urine sediment analyzer
  • the sampling needle is a sampling needle of an automatic urine analyzer or an automatic urine sediment analyzer the sampling needle.
  • a disposable urine collection tube that does not need to be opened, including: a tube cover, a diaphragm, and a tube body;
  • the diaphragm when the tube cover is connected with the tube body, the diaphragm is located between the tube body and the tube cover, thereby forming a closed space inside the tube body for containing the urine to be tested;
  • the septum is a membrane-like structure that is liquid-tight and allows the sampling needle to pass through, and has a pendant drop-like shape, and the pendant drop-like shape is selected from the following group: the septum is concave toward the bottom of the tube, or the septum is concave toward the bottom of the tube
  • the spout is convex, concave or the top of the convex portion has a piercing surface which is flat and fits and allows the sampling needle to pass through.
  • the puncture surface is circular, and the circular diameter ds ranges from 0mm ⁇ ds ⁇ 10mm.
  • the septum is fixedly disposed on, attached to, or adhered to the cap.
  • the thickness of the concave portion or the convex portion decreases gradually along the direction extending from the outer edge to the puncture surface.
  • the thickness of the concave part or the convex part is t1
  • the thickness of the piercing surface of the septum is t2
  • the value range of t1 is 0.5mm ⁇ t1 ⁇ 3mm; the value range of t2 is 5 ⁇ m ⁇ d ⁇ 1mm.
  • the ratio of t1 to t2 is ⁇ , wherein the value range of ⁇ is 2 ⁇ 10 6 .
  • the diaphragm further includes: a connection part, the thickness of the connection part is t3, wherein the range of t3 is 0.5mm ⁇ t3 ⁇ 3mm.
  • the cap-free disposable urine collection tube has a capacity of 5-20ml.
  • the tube cap and the tube body are detachably screwed together.
  • threads are provided on the connecting portion, and the connecting portion is configured to realize the threaded connection with the pipe body.
  • one or more stop protrusions are provided on the outer side of the tube cover along the circumference, for preventing the disposable urine collection tube from rolling freely when placed horizontally.
  • the non-penetrating notch is uniformly distributed along the circumference of the flat surface, and the non-penetrating notch is
  • the traces extend from the outer edge of the septum to the outer edge of the flat puncture surface, and the number of non-penetrating notches is n, and the range of n is 0 ⁇ n ⁇ 6.
  • the non-penetrating notch has one or more characteristics selected from the following group:
  • the ratio of the thickness of the non-penetrating notch to the thickness of the diaphragm ranges from 1% to 10%;
  • the value range of the height h3 from the piercing surface to the nozzle is: 2mm ⁇ h3 ⁇ 4mm.
  • the diaphragm is made of soft plastic material.
  • a plurality of reinforcing ribs are provided around the bottom of the nipple at the bottom of the tubular body.
  • the disposable urine collection tube is adapted to an automatic urine analyzer or an automatic urine sediment analyzer
  • the sampling needle is a sampling needle of an automatic urine analyzer or an automatic urine sediment analyzer the sampling needle.
  • the collection tube can remain still on the horizontal table, eliminating the inconvenience caused by random rolling or even falling of the collection tube;
  • the ratio of the thickness of the non-penetrating notch to the thickness of the diaphragm is 1%-10%. While the sampling needle is easy to penetrate, it ensures the sealing of the internal sample liquid and effectively avoids sample overflow.
  • the detachable diaphragm has various shapes and is suitable for different sampling needles to pass through.
  • the flat shape of the puncture surface is easy to realize in the manufacturing process.
  • Fig. 1 is a schematic structural view of a disposable urine collection tube according to the present invention
  • Fig. 2 is the front view of the disposable urine collection tube according to the utility model
  • Fig. 3 is the front view of the tube body (not including the tube cover) of the disposable urine collection tube according to the present utility model;
  • Fig. 4a is the top view of the cap (connected with a concave diaphragm toward the bottom of the tube) of the disposable urine collection tube according to the present invention
  • Fig. 4b is a bottom view of the cap (connected with a concave diaphragm towards the bottom of the tube) of the disposable urine collection tube according to the present utility model;
  • Fig. 4c is the bottom view of the tube cover (connected with the upward convex diaphragm towards the mouth of the tube) of the disposable urine collection tube according to the utility model;
  • Fig. 4 d is the top view of the cap (connected with the upward convex diaphragm towards the nozzle) of the disposable urine collection tube according to the present utility model;
  • Figure 5a is a top view of the diaphragm (including "Y" shaped notch) of the disposable urine collection tube according to the present invention.
  • Figure 5b is a top view of the diaphragm (including the "cross" shaped notch) of the disposable urine collection tube according to the present invention.
  • Fig. 6a is a top view structural diagram of the diaphragm (including "Y" shaped notch) of the disposable urine collection tube according to the present invention.
  • Fig. 6b is a top view structural diagram of the diaphragm (including the "cross" shaped notch) of the disposable urine collection tube according to the present utility model;
  • Fig. 7a is a schematic diagram of the structure of the diaphragm (including the "Y" shaped notch) of the disposable urine collection tube according to the utility model;
  • Fig. 7b is a schematic diagram of the structure of the diaphragm (including the "cross" shaped notch) of the disposable urine collection tube according to the utility model;
  • Fig. 8a is a schematic diagram of the thickness of the non-penetrating notch on the diaphragm of the disposable urine collection tube according to the present invention (concave in the shape of the hanging drop);
  • Fig. 8b is a schematic diagram of the thickness of the non-penetrating notch on the diaphragm of the disposable urine collection tube according to the present utility model (the shape of the hanging drop is convex);
  • Fig. 9 is a schematic diagram of a disposable urine collection tube according to the utility model (the tube cover is connected with a diaphragm protruding toward the mouth of the tube);
  • Fig. 10 is a schematic cross-sectional view of a disposable urine collection tube (the cap is connected with a diaphragm protruding upward towards the mouth of the tube) according to the utility model.
  • Fig. 11 is a front view of a disposable urine collection tube (with a convex or concave diaphragm connected to the cap) according to an embodiment of the present invention
  • Fig. 12 is a side view of a disposable urine collection tube (with a convex or concave diaphragm connected to the cap) according to an embodiment of the present utility model;
  • Fig. 13 is a perspective view of a disposable urine collection tube (with a convex or concave diaphragm connected to the tube cover) according to an embodiment of the present utility model;
  • Fig. 14a is a top view of the cap (diaphragm with a concave portion) of a disposable urine collection tube according to another embodiment of the present utility model;
  • Figure 14b is a bottom view of the cap (diaphragm with a concave portion) of a disposable urine collection tube according to another embodiment of the present utility model;
  • Fig. 14c is a side view of the cap (diaphragm with a convex portion or a concave portion) of a disposable urine collection tube according to another embodiment of the present utility model;
  • Fig. 15a is a top view of a septum (with a raised portion and a piercing surface) of a disposable urine collection tube according to another embodiment of the present utility model;
  • Fig. 15b is a top view of a diaphragm (with a concave portion and a piercing surface) of a disposable urine collection tube according to another embodiment of the present invention.
  • Figure 15c is a side view of a septum (with a raised portion and a piercing surface) of a disposable urine collection tube according to another embodiment of the present invention.
  • Fig. 15d is a side view of a septum (with a concave portion and a piercing surface) of a disposable urine collection tube according to another embodiment of the present invention.
  • Collection tube "urine collection tube”, “disposable urine collection tube” and “test tube” can be used interchangeably, and all refer to the disposable urine collection tube according to the present application.
  • a disposable urine collection tube as shown in FIGS. 1 to 2 includes a tube cover 10 , a first septum 20 and a tube body 30 .
  • the cap 10 is cylindrical, with a height of 10mm, an outer diameter of the top of 19.5mm-21.4mm, and an inner diameter of 13.5mm-15mm.
  • the circumferential direction of the through hole is provided with a flange 101 with a height of 2mm.
  • the flange 101 can buffer and protect the diaphragm arranged inside the cap.
  • One or more stop protrusions 102 are provided on the outside of the tube cover 10 along the circumferential direction to prevent the disposable urine collection tube from rolling freely when placed horizontally.
  • the stop protrusion is in a semicircular shape with a diameter of 3-6mm. There are preferably 4 stop protrusions, which are evenly distributed along the circumference.
  • the cap 10 can optionally be made of colored plastic.
  • the first septum 20 is fixedly disposed on, attached to, or adhered to the inner side of the tube cap 10 , that is, the side connected to the tube body, as shown in FIGS. 4 a to 4 b .
  • the septum is tightly sandwiched between the tube cover 10 and the tube body 30 when mated.
  • the first membrane 20 has a shape of a pendant drop.
  • the cap 10 to which the diaphragm is attached can be detachably connected to the body by a threaded connection, in this way, when connected to the body 30, the diaphragm is located between the cap and the body.
  • the shape of the hanging drop is concave towards the bottom of the tube, or convex towards the mouth of the tube.
  • the diameter is 20mm
  • the value range of the depth h 1 of the concave is 2mm ⁇ h1 ⁇ 6mm, preferably h1 is 4mm
  • the concave The inner diameter of the shape is 13mm.
  • the value range of the height h2 of the convexity is 2mm ⁇ h2 ⁇ 6mm, preferably h2 is 4mm, and the convexity can be Protrudes through the through hole in the top of the cap.
  • the thickness of the first diaphragm 20 is t, and the value range of t is 0.3 ⁇ t ⁇ 3mm; the diameter is d, and the value range of d is 8mm ⁇ d ⁇ 25mm. Preferably 10-20mm.
  • the thickness t 1 around the diaphragm ranges from 0.6-3 mm, preferably 0.8-1.5 mm; the thickness t 2 at the center of the diaphragm ranges from 0.3-1 mm, preferably 0.4-0.6 mm.
  • the notch may be in the shape of a "Y" or a "cross”; the thickness of the non-penetrating notch is 20 ⁇ m.
  • the cut-through rate is defined as the ratio of the thickness of the non-penetrating notch to the thickness of the diaphragm, and the cut-through rate ranges from 1% to 10%; the value range of the uncut thickness is 0.005-0.3mm. In this embodiment, the cut-through rate is 1%-10%.
  • the length of a single notch from the center to the outside is 11 mm, and the intersection center of the notch is the center of the through hole of the cap 10 .
  • the diaphragm of the first diaphragm 20 is made of soft plastic material.
  • the first membrane is a hydrophobic silicone membrane.
  • the tube body 30 is made of transparent plastic material. There are volume measurement scales and sample upper and lower limit warning lines on the tube body.
  • the height of the tube body is 105mm, the outer diameter is 16mm, and the inner diameter is 14mm.
  • At the bottom of the tube there is a fixed protrusion suitable for the automatic urine analyzer, that is, the bottom of the nipple, with a height of 12mm and a streamlined shape from top to bottom.
  • the capacity of the disposable urine collection tube without opening the cap is 5-20ml, preferably 8-15ml.
  • the patient collects the urine sample in the tube body 30, and puts the tube cap 10 on the tube body to be screwed tightly.
  • the non-penetrating notch diaphragm has airtightness, so that the sample liquid in the tube will not overflow when it is shaken.
  • the collection tube is sent to the automatic urine analyzer, and the sampling needle pierces through the first septum 20 without hindrance and enters the inner cavity of the tube to absorb the sample. After sampling, the disposable urine collection tube can be used and discarded immediately.
  • Another embodiment of the present application is as follows.
  • a disposable urine collection tube as shown in FIGS. 11 to 12 includes a tube cover 10 , a second septum 40 and a tube body 30 .
  • the cap 10 is cylindrical, with a height of 10 mm, an outer diameter of 19.5 mm-21.4 mm at the top, and an inner diameter of 13.5 mm-15 mm.
  • a through hole is arranged on the top, and the through hole runs through the cap;
  • a plurality of stop protrusions 102 are used to prevent the disposable urine collection tube from rolling freely when placed horizontally.
  • the stop protrusion is in a semicircular shape with a diameter of 3-6mm. There are preferably 4 stop protrusions, which are evenly distributed along the circumference.
  • the cap 10 can optionally be made of colored plastic.
  • the second diaphragm 40 is fixedly disposed on, attached to, or adhered to the inner side of the tube cap 10 , that is, the side connected to the tube body, as shown in FIGS. 11 to 13 .
  • the septum is tightly sandwiched between the tube cover 10 and the tube body 30 when mated.
  • the second membrane 40 has a shape of a pendant drop.
  • the shape of the hanging drop can have a convex part or a concave part.
  • the pendant drop shape has a raised portion, as shown in Figure 15a. At the top of the raised portion there is a flat surface, piercing surface 402, for fitting the autosampler and passing through the piercing needle.
  • the second diaphragm 40 also has a connecting portion 403, which is a circumferential flange on the outer periphery of the diaphragm and has a screw thread, so that the second diaphragm 40 can be detachably connected to the pipe body with a threaded connection. In this way, when connected When on the tube body 30, the diaphragm is located between the tube cover and the tube body.
  • the shape of the pendant drop is concave toward the bottom of the tube, or convex toward the mouth of the tube.
  • the diameter d s of the piercing surface ranges from 2 mm ⁇ d s ⁇ 10mm .
  • the value range of the height h 3 from the puncture surface to the nozzle is: 2mm ⁇ h 3 ⁇ 4mm.
  • the thickness of the second septum 40 is gradually changing, and the thickness decreases gradually along the direction extending from the concave portion or the convex portion along the outer edge to the puncture surface.
  • the thickness of the concave part is t 1
  • the value range of t 1 is 0.5mm ⁇ t 1 ⁇ 3mm
  • the thickness of the flat puncture surface is t 2
  • the value range of t 2 is 5 ⁇ m ⁇ d ⁇ 1mm.
  • the thickness t 2 of the piercing surface is 20-50 ⁇ m.
  • the thickness of the non-penetrating notch is 20 ⁇ m.
  • the ratio of the thickness of the non-penetrating notch to the thickness of the diaphragm is defined as the cut-through rate, and the cut-through rate ranges from 1% to 10%; the value range of the uncut thickness is 0.005-0.3mm. In this embodiment, the cut-through rate is 1%-10%.
  • the diaphragm of the second diaphragm 40 is made of soft plastic material.
  • the first membrane is a hydrophobic silicone membrane.
  • the tube body 30 is made of transparent plastic material. There are volume measurement scales and sample upper and lower limit warning lines on the tube body.
  • the height of the tube body is 105mm, the outer diameter is 16mm, and the inner diameter is 14mm.
  • At the bottom of the tube there is a fixed protrusion suitable for the automatic urine analyzer, that is, the bottom of the nipple, with a height of 12mm and a streamlined shape from top to bottom.
  • the capacity of the disposable urine collection tube without opening the cap is 5-20ml, preferably 8-15ml.
  • the patient When in use, the patient collects a urine sample in the tube body 30, and puts the tube cap 10 on the tube body to be screwed tightly. Since the puncture surface of the diaphragm is a flat surface, a high degree of sealing is ensured, and the probability of overflow of the liquid collected in the tube is close to 0%.
  • the collection tube is sent to the automatic urine analyzer, and the sampling needle pierces through the second septum 40 without hindrance and enters the inner cavity of the tube to absorb the sample. After sampling, the disposable urine collection tube can be used and discarded immediately.

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Abstract

A disposable urine collection tube without need to be uncapped, comprising a tube cap (10), a diaphragm (40) and a tube body (30), wherein when the tube cap (10) is connected to the tube body (30), the diaphragm (40) is located between the tube body (30) and the tube cap (10), so that a closed space for holding urine to be tested is formed in the tube body (30); and the diaphragm (40) is a membrane-like structure that is liquid-tight and allows a sampling needle to penetrate therethrough, and has a hanging drop shape selected from the diaphragm (40) being concave toward the tube bottom or the diaphragm (40) being convex toward the tube opening. The top of the concave portion or the convex portion (401) can have a puncture surface (402), and the puncture surface (402) is flat, and is adapted to the sampling needle to allow same to penetrate therethrough. When the sampling tube is used to test the urine to be tested, the testing sampling needle directly penetrates the diaphragm (40) to sample the urine to be tested without opening the tube cap (10). In addition, the collection tube is adapted to different sampling needles to penetrate therethrough.

Description

一种免开盖的一次性尿液采集管Disposable urine collection tube without opening cap 技术领域technical field
本申请涉及医学检验技术领域,特别地涉及一种一次性尿液采集管。The present application relates to the technical field of medical testing, in particular to a disposable urine collection tube.
背景技术Background technique
目前我国医疗机构已普及全自动尿液分析仪和尿沉渣分析仪,分析仪使用吸样针自动采集尿液进行后续检测。在此之前,检验人员必须手工逐一拧开采集管盖,这种样本前处理模式不仅增加了技术人员的低端、重复性的工作,同时增加了医务人员职业暴露风险。At present, medical institutions in my country have popularized automatic urine analyzers and urine sediment analyzers. The analyzers use aspiration needles to automatically collect urine for follow-up testing. Prior to this, inspectors had to manually unscrew the collection tube caps one by one. This sample pretreatment mode not only increased the low-end and repetitive work of technicians, but also increased the occupational exposure risk of medical staff.
发明内容Contents of the invention
本申请的发明人经过广泛的研究,研制了一种包括新型隔膜的一次性尿液采集管,在确保密封性能的前提下易于制造工艺的达成。After extensive research, the inventor of the present application has developed a disposable urine collection tube including a new type of diaphragm, which is easy to achieve the manufacturing process under the premise of ensuring the sealing performance.
本申请的一方面,公开了一种免开盖的一次性尿液收集管,包括:管盖、隔膜、和管体;In one aspect of the present application, a disposable urine collection tube that does not need to be opened is disclosed, including: a tube cover, a septum, and a tube body;
其中,当所述管盖与所述管体连接时,所述隔膜位于所述管体和所述管盖之间,从而在管体内部形成用于容纳待检尿液的密闭空间;Wherein, when the tube cover is connected with the tube body, the diaphragm is located between the tube body and the tube cover, thereby forming a closed space inside the tube body for containing the urine to be tested;
其中,所述隔膜为不透液体并且允许采样针穿过的膜状结构,并且具有悬滴样造型,所述的悬滴样造型选自下组:所述隔膜朝向管底下凹,或者隔膜朝向管口上凸;Wherein, the septum is a membrane-like structure that is liquid-tight and allows the sampling needle to pass through, and has a pendant drop-like shape, and the pendant drop-like shape is selected from the following group: the septum is concave toward the bottom of the tube, or the septum is concave toward the bottom of the tube Nozzle convex;
所述免开盖的一次性尿液收集管被配置为:在采样时,可打开所述管盖,在管体中装入待检尿液并随后盖上管盖,将所述待检尿液密闭于所述一次性尿液收集管中;在对所述待检尿液进行检测时,检测采样针在无需打开所述管盖的情况下,直接穿过所述隔膜并对所述待检尿液进行采样。The disposable urine collection tube without opening the cover is configured as follows: when sampling, the tube cover can be opened, the urine to be tested is loaded into the tube body and then the tube cover is covered, and the urine to be tested is collected. The liquid is sealed in the disposable urine collection tube; when the urine to be tested is detected, the detection sampling needle directly passes through the septum without opening the tube cover and passes through the urine to be tested. Take a urine sample.
在一个优选例中,所述的下凹的深度h1(指下凹的最低点距离隔膜四周所处平面的距离h1)≥2mm,较佳地≥3mm,更佳地2-6mm。In a preferred example, the depth h1 of the depression (referring to the distance h1 between the lowest point of the depression and the plane surrounding the diaphragm) is ≥ 2 mm, preferably ≥ 3 mm, more preferably 2-6 mm.
在一个优选例中,所述的上凸的高度h2(指上凸的最高点距离隔膜四周所处平面的距离h2)≥2mm,较佳地≥3mm,更佳地2-6mm。In a preferred example, the height h2 of the bulge (referring to the distance h2 between the highest point of the bulge and the plane around the diaphragm) is ≥ 2 mm, preferably ≥ 3 mm, more preferably 2-6 mm.
在一个优选例中,所述隔膜是固定设置于、附着于、或粘附于所述管盖。In a preferred example, the septum is fixedly disposed on, attached to, or adhered to the cap.
在一个优选例中,所述隔膜的厚度为t,直径为d,t的取值范围0.3≤t≤3mm;d的取值范围8≤d≤25mm。In a preferred example, the diaphragm has a thickness of t and a diameter of d, and the value range of t is 0.3≤t≤3mm; the value range of d is 8≤d≤25mm.
在一个优选例中,所述免开盖的一次性尿液收集管的容量5-20ml。In a preferred example, the cap-free disposable urine collection tube has a capacity of 5-20ml.
在一个优选例中,所述管盖与所述管体为可拆卸的螺纹连接。In a preferred example, the tube cap and the tube body are detachably screwed together.
在一个优选例中,所述管盖沿周向的外侧设置有一个或多个止动突,用于防止所述一次性尿液收集管横置在水平面上时的随意滚动。In a preferred example, one or more stop protrusions are provided on the outer side of the tube cover along the circumference, for preventing the disposable urine collection tube from rolling freely when placed horizontally.
在一个优选例中,所述隔膜上允许采样针穿过的膜状结构为非贯通性切迹。In a preferred example, the membranous structure on the septum that allows the sampling needle to pass through is a non-penetrating notch.
在一个优选例中,所述非贯通性切迹具有选自下组的一个或多个特征:In a preferred example, the non-penetrating notch has one or more characteristics selected from the following group:
(a)非贯通性切迹的厚度与隔膜的厚度比的取值范围为1%-10%;(a) The ratio of the thickness of the non-penetrating notch to the thickness of the diaphragm ranges from 1% to 10%;
(b)未切穿的厚度的取值范围为0.005-0.3mm。(b) The value range of the uncut thickness is 0.005-0.3mm.
在一个优选例中,所述非贯通性切迹为“十”字形或者“丫”字形。In a preferred example, the non-penetrating notch is in the shape of a "ten" or a "Y".
在一个优选例中,所述隔膜为软质可塑性材质。In a preferred example, the diaphragm is made of soft plastic material.
在一个优选例中,所述管体底部的乳头底周围设置有多个加强筋。In a preferred example, a plurality of reinforcing ribs are provided around the bottom of the nipple at the bottom of the tubular body.
在一个优选例中,所述一次性尿液收集管用于与自动尿液分析仪或自 动尿沉渣分析仪适配,并且所述采样针为自动尿液分析仪的采样针或自动尿沉渣分析仪的采样针。In a preferred example, the disposable urine collection tube is adapted to an automatic urine analyzer or an automatic urine sediment analyzer, and the sampling needle is a sampling needle of an automatic urine analyzer or an automatic urine sediment analyzer the sampling needle.
本申请的另一方面,公开了一种免开盖的一次性尿液采集管,包括:管盖、隔膜、和管体;Another aspect of the present application discloses a disposable urine collection tube that does not need to be opened, including: a tube cover, a diaphragm, and a tube body;
其中,当所述管盖与所述管体连接时,所述隔膜位于所述管体和所述管盖之间,从而在管体内部形成用于容纳待检尿液的密闭空间;Wherein, when the tube cover is connected with the tube body, the diaphragm is located between the tube body and the tube cover, thereby forming a closed space inside the tube body for containing the urine to be tested;
其中,所述隔膜为不透液体并且允许采样针穿过的膜状结构,并且具有悬滴样造型,所述的悬滴样造型选自下组:所述隔膜朝向管底下凹,或者隔膜朝向管口上凸,下凹部分或上凸部分的顶部具有穿刺表面,所述穿刺表面是平坦的,适配并允许采样针穿过。Wherein, the septum is a membrane-like structure that is liquid-tight and allows the sampling needle to pass through, and has a pendant drop-like shape, and the pendant drop-like shape is selected from the following group: the septum is concave toward the bottom of the tube, or the septum is concave toward the bottom of the tube The spout is convex, concave or the top of the convex portion has a piercing surface which is flat and fits and allows the sampling needle to pass through.
在一个优选例中,所述穿刺表面为圆形,所述圆形直径ds取值范围为0mm<ds≤10mm。In a preferred example, the puncture surface is circular, and the circular diameter ds ranges from 0mm<ds≤10mm.
在一个优选例中,所述隔膜是固定设置于、附着于、或粘附于所述管盖。In a preferred example, the septum is fixedly disposed on, attached to, or adhered to the cap.
在一个优选例中,所述下凹部分或所述上凸部分沿着外缘延伸至穿刺表面的方向,厚度递减。In a preferred example, the thickness of the concave portion or the convex portion decreases gradually along the direction extending from the outer edge to the puncture surface.
在一个优选例中,下凹部分或所述上凸的部分的厚度为t1,所述隔膜的所述穿刺表面厚度为t2,其中,In a preferred example, the thickness of the concave part or the convex part is t1, and the thickness of the piercing surface of the septum is t2, wherein,
t1的取值范围0.5mm≤t1≤3mm;t2的取值范围5μm≤d≤1mm。The value range of t1 is 0.5mm≤t1≤3mm; the value range of t2 is 5μm≤d≤1mm.
在一个优选例中,t1与t2的比值为δ,其中,δ的取值范围为2≤δ≤10 6In a preferred example, the ratio of t1 to t2 is δ, wherein the value range of δ is 2≤δ≤10 6 .
在一个优选例中,所述隔膜还包括:连接部,所述连接部的厚度为t3,其中,t3取值范围为0.5mm≤t3≤3mm。In a preferred example, the diaphragm further includes: a connection part, the thickness of the connection part is t3, wherein the range of t3 is 0.5mm≤t3≤3mm.
在一个优选例中,所述免开盖的一次性尿液采集管的容量5-20ml。In a preferred example, the cap-free disposable urine collection tube has a capacity of 5-20ml.
在一个优选例中,所述管盖与所述管体为可拆卸的螺纹连接。In a preferred example, the tube cap and the tube body are detachably screwed together.
在一个优选例中,所述连接部上设置有螺纹,所述连接部配置为与所述管体实现所述螺纹连接。In a preferred example, threads are provided on the connecting portion, and the connecting portion is configured to realize the threaded connection with the pipe body.
在一个优选例中,所述管盖沿周向的外侧设置有一个或多个止动突,用于防止所述一次性尿液采集管横置在水平面上时的随意滚动。In a preferred example, one or more stop protrusions are provided on the outer side of the tube cover along the circumference, for preventing the disposable urine collection tube from rolling freely when placed horizontally.
在一个优选例中,所述隔膜上具有辅助采样针穿过的膜状结构的非贯通性切迹,所述非贯通切迹沿着所述平坦表面的圆周均布,所述非贯通性切迹从所述隔膜的外缘延伸至平穿刺表面外缘,所述非贯通切迹根数为n,n取值范围为0≤n≤6。In a preferred example, there is a non-penetrating notch on the membrane to assist the sampling needle to pass through, the non-penetrating notch is uniformly distributed along the circumference of the flat surface, and the non-penetrating notch is The traces extend from the outer edge of the septum to the outer edge of the flat puncture surface, and the number of non-penetrating notches is n, and the range of n is 0≤n≤6.
在一个优选例中,所述非贯通性切迹具有选自下组的一个或多个特征:In a preferred example, the non-penetrating notch has one or more characteristics selected from the following group:
(a)非贯通性切迹的厚度与隔膜的厚度比的取值范围为1%-10%;(a) The ratio of the thickness of the non-penetrating notch to the thickness of the diaphragm ranges from 1% to 10%;
(b)未切穿的厚度的取值范围为0.005-0.3mm。(b) The value range of the uncut thickness is 0.005-0.3mm.
在一个优选例中,所述穿刺表面距离管口的高度h3的取值范围为:2mm≤h3≤4mm。In a preferred example, the value range of the height h3 from the piercing surface to the nozzle is: 2mm≤h3≤4mm.
在一个优选例中,所述隔膜为软质可塑性材质。In a preferred example, the diaphragm is made of soft plastic material.
在一个优选例中,所述管体底部的乳头底周围设置有多个加强筋。In a preferred example, a plurality of reinforcing ribs are provided around the bottom of the nipple at the bottom of the tubular body.
在一个优选例中,所述一次性尿液采集管用于与自动尿液分析仪或自动尿沉渣分析仪适配,并且所述采样针为自动尿液分析仪的采样针或自动尿沉渣分析仪的采样针。In a preferred example, the disposable urine collection tube is adapted to an automatic urine analyzer or an automatic urine sediment analyzer, and the sampling needle is a sampling needle of an automatic urine analyzer or an automatic urine sediment analyzer the sampling needle.
根据本申请的一次性尿液收集管至少具有以下技术效果:The disposable urine collection tube according to the present application has at least the following technical effects:
1.不需人工脱盖,直接上机检测,完善了尿液分析的全自动流程,极 大地减少了检验人员的工作量、增进了的工作舒适度,提高了检验人员的医疗防护水平;1. It does not need to be manually removed, and it can be tested directly on the machine, which improves the automatic process of urine analysis, greatly reduces the workload of the inspectors, improves the working comfort, and improves the medical protection level of the inspectors;
2.减少污染尿液样品的风险;2. Reduce the risk of contamination of urine samples;
3.采集管可在水平桌面上保持静止,消除采集管随机滚动、甚至跌落给使用带来的不便;3. The collection tube can remain still on the horizontal table, eliminating the inconvenience caused by random rolling or even falling of the collection tube;
4.非贯通性切迹的厚度与隔膜的厚度比为1%-10%,在易于采样针穿透的同时,保证内部样品液体的密封性,有效避免样品溢出。4. The ratio of the thickness of the non-penetrating notch to the thickness of the diaphragm is 1%-10%. While the sampling needle is easy to penetrate, it ensures the sealing of the internal sample liquid and effectively avoids sample overflow.
5.可拆卸的隔膜造型多样,适配于不同的采样针穿过。5. The detachable diaphragm has various shapes and is suitable for different sampling needles to pass through.
6.穿刺表面的平坦造型在制造工艺上易于实现。6. The flat shape of the puncture surface is easy to realize in the manufacturing process.
附图说明Description of drawings
图1为根据本实用新型的一次性尿液采集管的结构示意图;Fig. 1 is a schematic structural view of a disposable urine collection tube according to the present invention;
图2为根据本实用新型的一次性尿液采集管的正视图;Fig. 2 is the front view of the disposable urine collection tube according to the utility model;
图3为根据本实用新型的一次性尿液采集管的管体(不包含管盖)的正视图;Fig. 3 is the front view of the tube body (not including the tube cover) of the disposable urine collection tube according to the present utility model;
图4a为根据本实用新型的一次性尿液采集管的管盖(连接有朝向管底的下凹隔膜)的俯视图;Fig. 4a is the top view of the cap (connected with a concave diaphragm toward the bottom of the tube) of the disposable urine collection tube according to the present invention;
图4b为根据本实用新型的一次性尿液采集管的管盖(连接有朝向管底的下凹隔膜)的仰视图;Fig. 4b is a bottom view of the cap (connected with a concave diaphragm towards the bottom of the tube) of the disposable urine collection tube according to the present utility model;
图4c为根据本实用新型的一次性尿液采集管的管盖(连接有朝向管口的上凸隔膜)的仰视图;Fig. 4c is the bottom view of the tube cover (connected with the upward convex diaphragm towards the mouth of the tube) of the disposable urine collection tube according to the utility model;
图4d为根据本实用新型的一次性尿液采集管的管盖(连接有朝向管口 的上凸隔膜)的俯视图;Fig. 4 d is the top view of the cap (connected with the upward convex diaphragm towards the nozzle) of the disposable urine collection tube according to the present utility model;
图5a为根据本实用新型的一次性尿液采集管的隔膜(包括“丫”字形切迹)俯视图;Figure 5a is a top view of the diaphragm (including "Y" shaped notch) of the disposable urine collection tube according to the present invention;
图5b为根据本实用新型的一次性尿液采集管的隔膜(包括“十”字形切迹)俯视图;Figure 5b is a top view of the diaphragm (including the "cross" shaped notch) of the disposable urine collection tube according to the present invention;
图6a为根据本实用新型的一次性尿液采集管的隔膜(包括“丫”字形切迹)俯视结构示意图;Fig. 6a is a top view structural diagram of the diaphragm (including "Y" shaped notch) of the disposable urine collection tube according to the present invention;
图6b为根据本实用新型的一次性尿液采集管的隔膜(包括“十”字形切迹)俯视结构示意图;Fig. 6b is a top view structural diagram of the diaphragm (including the "cross" shaped notch) of the disposable urine collection tube according to the present utility model;
图7a为根据本实用新型的一次性尿液采集管的隔膜(包括“丫”字形切迹)仰视结构示意图;Fig. 7a is a schematic diagram of the structure of the diaphragm (including the "Y" shaped notch) of the disposable urine collection tube according to the utility model;
图7b为根据本实用新型的一次性尿液采集管的隔膜(包括“十”字形切迹)仰视结构示意图;Fig. 7b is a schematic diagram of the structure of the diaphragm (including the "cross" shaped notch) of the disposable urine collection tube according to the utility model;
图8a为根据本实用新型的一次性尿液采集管的隔膜(悬滴样造型下凹)上的非贯通性切迹的厚度示意图;Fig. 8a is a schematic diagram of the thickness of the non-penetrating notch on the diaphragm of the disposable urine collection tube according to the present invention (concave in the shape of the hanging drop);
图8b为根据本实用新型的一次性尿液采集管的隔膜(悬滴样造型上凸)上的非贯通性切迹的厚度示意图;Fig. 8b is a schematic diagram of the thickness of the non-penetrating notch on the diaphragm of the disposable urine collection tube according to the present utility model (the shape of the hanging drop is convex);
图9为根据本实用新型的一次性尿液采集管(管盖连接有朝向管口上凸的隔膜)的示意图;Fig. 9 is a schematic diagram of a disposable urine collection tube according to the utility model (the tube cover is connected with a diaphragm protruding toward the mouth of the tube);
图10为根据本实用新型的一次性尿液采集管(管盖连接有朝向管口上凸的隔膜)的剖面示意图。Fig. 10 is a schematic cross-sectional view of a disposable urine collection tube (the cap is connected with a diaphragm protruding upward towards the mouth of the tube) according to the utility model.
图11为根据本实用新型的一实施例的一次性尿液采集管(管盖连接有具有上凸或下凹的隔膜)的正视图;Fig. 11 is a front view of a disposable urine collection tube (with a convex or concave diaphragm connected to the cap) according to an embodiment of the present invention;
图12为根据本实用新型的一实施例的一次性尿液采集管(管盖连接有具有上凸或下凹的隔膜)的侧视图;Fig. 12 is a side view of a disposable urine collection tube (with a convex or concave diaphragm connected to the cap) according to an embodiment of the present utility model;
图13为根据本实用新型的一实施例的一次性尿液采集管(管盖连接有具有上凸或下凹的隔膜)的立体图;Fig. 13 is a perspective view of a disposable urine collection tube (with a convex or concave diaphragm connected to the tube cover) according to an embodiment of the present utility model;
图14a为根据本实用新型的另一实施例的一次性尿液采集管的管盖(具有下凹部分的隔膜)的俯视图;Fig. 14a is a top view of the cap (diaphragm with a concave portion) of a disposable urine collection tube according to another embodiment of the present utility model;
图14b为根据本实用新型的另一实施例的一次性尿液采集管的管盖(具有下凹部分的隔膜)的仰视图;Figure 14b is a bottom view of the cap (diaphragm with a concave portion) of a disposable urine collection tube according to another embodiment of the present utility model;
图14c为根据本实用新型的另一实施例的一次性尿液采集管的管盖(具有上凸部分或下凹部分的隔膜)的侧视图;Fig. 14c is a side view of the cap (diaphragm with a convex portion or a concave portion) of a disposable urine collection tube according to another embodiment of the present utility model;
图15a为根据本实用新型的另一实施例的一次性尿液采集管的隔膜(具有上凸部分和穿刺表面)的俯视图;Fig. 15a is a top view of a septum (with a raised portion and a piercing surface) of a disposable urine collection tube according to another embodiment of the present utility model;
图15b为根据本实用新型的另一实施例的一次性尿液采集管的隔膜(具有下凹部分和穿刺表面)的俯视图;Fig. 15b is a top view of a diaphragm (with a concave portion and a piercing surface) of a disposable urine collection tube according to another embodiment of the present invention;
图15c为根据本实用新型的另一实施例的一次性尿液采集管的隔膜(具有上凸部分和穿刺表面)的侧视图;Figure 15c is a side view of a septum (with a raised portion and a piercing surface) of a disposable urine collection tube according to another embodiment of the present invention;
图15d为根据本实用新型的另一实施例的一次性尿液采集管的隔膜(具有下凹部分和穿刺表面)的侧视图。Fig. 15d is a side view of a septum (with a concave portion and a piercing surface) of a disposable urine collection tube according to another embodiment of the present invention.
附图标记说明:Explanation of reference signs:
10-管盖10-tube cap
101-凸缘101-flange
102-止动突102-stop protrusion
20-第一隔膜20 - first diaphragm
30-管体30-tube body
40-第二隔膜40 - second diaphragm
401-上凸部分401-upper convex part
402-平坦表面402-flat surface
403-连接部403-connection part
具体实施方式Detailed ways
在以下的叙述中,为了使读者更好地理解本申请而提出了许多技术细节。但是,本领域的普通技术人员可以理解,即使没有这些技术细节和基于以下各实施方式的种种变化和修改,也可以实现本申请所要求保护的技术方案。In the following description, many technical details are proposed in order to enable readers to better understand the application. However, those skilled in the art can understand that the technical solutions claimed in this application can be realized even without these technical details and various changes and modifications based on the following implementation modes.
术语the term
“采集管”、“尿液采集管”、“一次性尿液采集管”、“试管”可互换使用,均指代根据本申请的一次性尿液采集管。"Collection tube", "urine collection tube", "disposable urine collection tube" and "test tube" can be used interchangeably, and all refer to the disposable urine collection tube according to the present application.
如图1至图2所示的一种一次性尿液采集管,包括管盖10、第一隔膜20和管体30。管盖10为圆柱形,高度为10mm,顶部外径19.5mm-21.4mm,内径13.5mm-15mm,顶部设置有通孔,通孔贯穿管盖;管盖外侧,即背离管体的一侧,通孔的周向设置有凸缘101,高起2mm。该凸缘101可对设置在管盖内侧的隔膜具有一定的缓冲和保护作用。管盖10沿周向的外侧设置有一个或多个止动突102,用于防止所述一次性尿液采集管横置在水平面上时的随意滚动。止动突为半圆造型,直径3-6mm。止动突优选为4个,沿圆周均匀分布。管盖10可选地使用有色塑料材质。A disposable urine collection tube as shown in FIGS. 1 to 2 includes a tube cover 10 , a first septum 20 and a tube body 30 . The cap 10 is cylindrical, with a height of 10mm, an outer diameter of the top of 19.5mm-21.4mm, and an inner diameter of 13.5mm-15mm. There is a through hole on the top, and the through hole runs through the cap; the outer side of the cap is the side away from the body. The circumferential direction of the through hole is provided with a flange 101 with a height of 2mm. The flange 101 can buffer and protect the diaphragm arranged inside the cap. One or more stop protrusions 102 are provided on the outside of the tube cover 10 along the circumferential direction to prevent the disposable urine collection tube from rolling freely when placed horizontally. The stop protrusion is in a semicircular shape with a diameter of 3-6mm. There are preferably 4 stop protrusions, which are evenly distributed along the circumference. The cap 10 can optionally be made of colored plastic.
第一隔膜20以固定设置于、附着于、或粘附的形式固定设置在管盖 10内侧,即与管身连接的一侧,如图4a至图4b所示。可选地,隔膜被管盖10和管体30配合时紧密夹在中间。第一隔膜20具有悬滴样造型。连接有隔膜的管盖10可以以螺纹连接可拆卸地连接到管体上,以此方式,当连接于管体30上时,隔膜即位于管盖、管体之间。悬滴样造型朝向朝向管底下凹,或者朝向管口上凸。如图5a至图7b所示,当悬滴样造型朝向管底下凹时,直径为20mm,内凹的深度h 1的取值范围为2mm≤h 1≤6mm,优选地h 1为4mm,凹形内径13mm。如图9至图10所示,当悬滴样造型朝向管口上凸时,上凸的高度h 2的取值范围为2mm≤h 2≤6mm,优选地优选地h 2为4mm,上凸可穿过管盖顶部的通孔凸出。 The first septum 20 is fixedly disposed on, attached to, or adhered to the inner side of the tube cap 10 , that is, the side connected to the tube body, as shown in FIGS. 4 a to 4 b . Optionally, the septum is tightly sandwiched between the tube cover 10 and the tube body 30 when mated. The first membrane 20 has a shape of a pendant drop. The cap 10 to which the diaphragm is attached can be detachably connected to the body by a threaded connection, in this way, when connected to the body 30, the diaphragm is located between the cap and the body. The shape of the hanging drop is concave towards the bottom of the tube, or convex towards the mouth of the tube. As shown in Figures 5a to 7b, when the shape of the pendant drop is concave toward the bottom of the tube, the diameter is 20mm, and the value range of the depth h 1 of the concave is 2mm≤h1≤6mm, preferably h1 is 4mm, and the concave The inner diameter of the shape is 13mm. As shown in Figures 9 to 10, when the pendant drop-like shape is convex toward the mouth of the nozzle, the value range of the height h2 of the convexity is 2mm≤h2≤6mm, preferably h2 is 4mm, and the convexity can be Protrudes through the through hole in the top of the cap.
第一隔膜20的厚度为t,t的取值范围0.3≤t≤3mm;直径为d,d的取值范围8mm≤d≤25mm。较佳地10-20mm。在另一优选例中,隔膜四周的厚度t 1的取值范围为0.6-3mm,较佳地0.8-1.5mm;隔膜中心部位的厚度t 2为0.3-1mm,较佳地0.4-0.6mm。 The thickness of the first diaphragm 20 is t, and the value range of t is 0.3≤t≤3mm; the diameter is d, and the value range of d is 8mm≤d≤25mm. Preferably 10-20mm. In another preferred example, the thickness t 1 around the diaphragm ranges from 0.6-3 mm, preferably 0.8-1.5 mm; the thickness t 2 at the center of the diaphragm ranges from 0.3-1 mm, preferably 0.4-0.6 mm.
如图5a至图7b所示,第一隔膜20上具有非贯通性切迹;切迹可选地为“丫”字形或“十”字形;非贯通性切迹的厚度20μm。定义非贯通性切迹的厚度与隔膜的厚度比为切穿率,则切穿率范围为1%-10%;未切穿的厚度的取值范围为0.005-0.3mm。本实施例中,切穿率为1%-10%。单个切迹由圆心向外长度均为11mm,切迹的交汇中心即管盖10的通孔圆心。As shown in FIG. 5a to FIG. 7b , there is a non-penetrating notch on the first diaphragm 20; the notch may be in the shape of a "Y" or a "cross"; the thickness of the non-penetrating notch is 20 μm. The cut-through rate is defined as the ratio of the thickness of the non-penetrating notch to the thickness of the diaphragm, and the cut-through rate ranges from 1% to 10%; the value range of the uncut thickness is 0.005-0.3mm. In this embodiment, the cut-through rate is 1%-10%. The length of a single notch from the center to the outside is 11 mm, and the intersection center of the notch is the center of the through hole of the cap 10 .
第一隔膜20膜片为软质可塑性材质。在一个实施例中,第一隔膜为疏水硅胶膜。The diaphragm of the first diaphragm 20 is made of soft plastic material. In one embodiment, the first membrane is a hydrophobic silicone membrane.
如图3所示,管体30由透明塑料材质制成。再管体上具有体积计量刻度和样品上下限警示线。管体高度105mm,外径16mm,内径14mm。管底部有全自动尿液分析仪适配的固定突,即乳头底,高度12mm,由上至下呈流线形。As shown in FIG. 3 , the tube body 30 is made of transparent plastic material. There are volume measurement scales and sample upper and lower limit warning lines on the tube body. The height of the tube body is 105mm, the outer diameter is 16mm, and the inner diameter is 14mm. At the bottom of the tube, there is a fixed protrusion suitable for the automatic urine analyzer, that is, the bottom of the nipple, with a height of 12mm and a streamlined shape from top to bottom.
免开盖的一次性尿液采集管的容量5-20ml,较佳地8-15ml。The capacity of the disposable urine collection tube without opening the cap is 5-20ml, preferably 8-15ml.
使用时,患者将尿液样品收集于管体30内,将管盖10置于管体上依靠螺纹旋紧。非贯穿切迹隔膜具有密封性,以使管体内的样品液体在受到震荡情况下不溢出。将采集管送至自动尿液分析仪中,采样针无障碍地刺破第一隔膜20进入管体内腔吸取样本。取样完毕后,该一次性尿液采集管即用即弃。During use, the patient collects the urine sample in the tube body 30, and puts the tube cap 10 on the tube body to be screwed tightly. The non-penetrating notch diaphragm has airtightness, so that the sample liquid in the tube will not overflow when it is shaken. The collection tube is sent to the automatic urine analyzer, and the sampling needle pierces through the first septum 20 without hindrance and enters the inner cavity of the tube to absorb the sample. After sampling, the disposable urine collection tube can be used and discarded immediately.
本申请的另一个实施例如下。Another embodiment of the present application is as follows.
如图11至图12所示的一种一次性尿液采集管,包括管盖10、第二第二隔膜40和管体30。管盖10为圆柱形,高度为10mm,顶部外径19.5mm-21.4mm,内径13.5mm-15mm,顶部设置有通孔,通孔贯穿管盖;管盖10沿周向的外侧设置有一个或多个止动突102,用于防止所述一次性尿液采集管横置在水平面上时的随意滚动。止动突为半圆造型,直径3-6mm。止动突优选为4个,沿圆周均匀分布。管盖10可选地使用有色塑料材质。A disposable urine collection tube as shown in FIGS. 11 to 12 includes a tube cover 10 , a second septum 40 and a tube body 30 . The cap 10 is cylindrical, with a height of 10 mm, an outer diameter of 19.5 mm-21.4 mm at the top, and an inner diameter of 13.5 mm-15 mm. A through hole is arranged on the top, and the through hole runs through the cap; A plurality of stop protrusions 102 are used to prevent the disposable urine collection tube from rolling freely when placed horizontally. The stop protrusion is in a semicircular shape with a diameter of 3-6mm. There are preferably 4 stop protrusions, which are evenly distributed along the circumference. The cap 10 can optionally be made of colored plastic.
第二隔膜40以固定设置于、附着于、或粘附的形式固定设置在管盖10内侧,即与管身连接的一侧,如图11至图13所示。可选地,隔膜被管盖10和管体30配合时紧密夹在中间。第二隔膜40具有悬滴样造型。悬滴样造型可以具有上凸部分,也可以具有下凹部分。在一个实施例中,悬滴样造型具有上凸部分,如图15a所示。在上凸部分的顶部有一平坦的表面,即穿刺表面402,用于适配自动采样仪并由穿刺针穿过。第二隔膜40还具有连接部403,连接部403是隔膜外周的圆周状突缘,并具有螺纹,可将第二隔膜40以螺纹连接可拆卸地连接到管体上,以此方式,当连接于管体30上时,隔膜即位于管盖、管体之间。在一个实施例中,如图15b所示,悬滴样造型朝向朝向管底下凹,或者朝向管口上凸。如图15b所示,当悬滴样造型朝向管底下凹时,穿刺表面的直径d s取值范围为 2mm≤d s≤10mm。 穿刺表面距离管口的高度h 3的取值范围为:2mm≤h 3≤4mm。 The second diaphragm 40 is fixedly disposed on, attached to, or adhered to the inner side of the tube cap 10 , that is, the side connected to the tube body, as shown in FIGS. 11 to 13 . Optionally, the septum is tightly sandwiched between the tube cover 10 and the tube body 30 when mated. The second membrane 40 has a shape of a pendant drop. The shape of the hanging drop can have a convex part or a concave part. In one embodiment, the pendant drop shape has a raised portion, as shown in Figure 15a. At the top of the raised portion there is a flat surface, piercing surface 402, for fitting the autosampler and passing through the piercing needle. The second diaphragm 40 also has a connecting portion 403, which is a circumferential flange on the outer periphery of the diaphragm and has a screw thread, so that the second diaphragm 40 can be detachably connected to the pipe body with a threaded connection. In this way, when connected When on the tube body 30, the diaphragm is located between the tube cover and the tube body. In one embodiment, as shown in Fig. 15b, the shape of the pendant drop is concave toward the bottom of the tube, or convex toward the mouth of the tube. As shown in Figure 15b, when the shape of the pendant drop is concave toward the bottom of the tube, the diameter d s of the piercing surface ranges from 2 mm≤d s≤10mm . The value range of the height h 3 from the puncture surface to the nozzle is: 2mm≤h 3 ≤4mm.
第二隔膜40的厚度是渐变的,自下凹部分或者上凸部分沿着外缘延伸至穿刺表面的方向厚度递减。如图15b所示,下凹部分的厚度为t 1,t 1取值范围0.5mm≤t 1≤3mm;平坦的穿刺表面厚度为t 2,t 2的取值范围5μm≤d≤1mm。在另一优选例中,穿刺表面的厚度t 2为20-50μm。 The thickness of the second septum 40 is gradually changing, and the thickness decreases gradually along the direction extending from the concave portion or the convex portion along the outer edge to the puncture surface. As shown in Figure 15b, the thickness of the concave part is t 1 , and the value range of t 1 is 0.5mm≤t 1 ≤3mm; the thickness of the flat puncture surface is t 2 , and the value range of t 2 is 5μm≤d≤1mm. In another preferred example, the thickness t 2 of the piercing surface is 20-50 μm.
如图15a至图15d所示,第二隔膜40上具有非贯通性切迹;非贯通性切迹的厚度20μm。定义非贯通性切迹的厚度与隔膜的厚度比为切穿率,则切穿率范围为1%-10%;未切穿的厚度的取值范围为0.005-0.3mm。本实施例中,切穿率为1%-10%。As shown in FIGS. 15 a to 15 d , there is a non-penetrating notch on the second diaphragm 40 ; the thickness of the non-penetrating notch is 20 μm. The ratio of the thickness of the non-penetrating notch to the thickness of the diaphragm is defined as the cut-through rate, and the cut-through rate ranges from 1% to 10%; the value range of the uncut thickness is 0.005-0.3mm. In this embodiment, the cut-through rate is 1%-10%.
第二隔膜40膜片为软质可塑性材质。在一个实施例中,第一隔膜为疏水硅胶膜。The diaphragm of the second diaphragm 40 is made of soft plastic material. In one embodiment, the first membrane is a hydrophobic silicone membrane.
管体30由透明塑料材质制成。再管体上具有体积计量刻度和样品上下限警示线。管体高度105mm,外径16mm,内径14mm。管底部有全自动尿液分析仪适配的固定突,即乳头底,高度12mm,由上至下呈流线形。The tube body 30 is made of transparent plastic material. There are volume measurement scales and sample upper and lower limit warning lines on the tube body. The height of the tube body is 105mm, the outer diameter is 16mm, and the inner diameter is 14mm. At the bottom of the tube, there is a fixed protrusion suitable for the automatic urine analyzer, that is, the bottom of the nipple, with a height of 12mm and a streamlined shape from top to bottom.
免开盖的一次性尿液采集管的容量5-20ml,较佳地8-15ml。The capacity of the disposable urine collection tube without opening the cap is 5-20ml, preferably 8-15ml.
使用时,患者将尿液样品采集于管体30内,将管盖10置于管体上依靠螺纹旋紧。由于隔膜的穿刺表面为平坦表面,保证高度的密封性,管内采集液体溢出几率接近于0%。将采集管送至自动尿液分析仪中,采样针无障碍地刺破第二隔膜40进入管体内腔吸取样本。取样完毕后,该一次性尿液采集管即用即弃。When in use, the patient collects a urine sample in the tube body 30, and puts the tube cap 10 on the tube body to be screwed tightly. Since the puncture surface of the diaphragm is a flat surface, a high degree of sealing is ensured, and the probability of overflow of the liquid collected in the tube is close to 0%. The collection tube is sent to the automatic urine analyzer, and the sampling needle pierces through the second septum 40 without hindrance and enters the inner cavity of the tube to absorb the sample. After sampling, the disposable urine collection tube can be used and discarded immediately.
在本申请提及的所有文献都被认为是整体性地包括在本申请的公开内容中,以便在必要时可以作为修改的依据。此外应理解,在阅读了本申请的上述公开内容之后,本领域技术人员可以对本申请作各种改动或修改,这些等价形式同样落于本申请所要求保护的范围。All documents mentioned in this application are considered to be included in the disclosure content of this application in their entirety so that they can be used as a basis for amendments when necessary. In addition, it should be understood that after reading the above disclosure content of the application, those skilled in the art may make various changes or modifications to the application, and these equivalent forms also fall within the scope of protection claimed in the application.

Claims (31)

  1. 一种免开盖的一次性尿液采集管,其特征在于,包括:管盖、隔膜、和管体;A disposable urine collection tube without opening the cover, characterized in that it includes: a tube cover, a diaphragm, and a tube body;
    其中,当所述管盖与所述管体连接时,所述隔膜位于所述管体和所述管盖之间,从而在管体内部形成用于容纳待检尿液的密闭空间;Wherein, when the tube cover is connected with the tube body, the diaphragm is located between the tube body and the tube cover, thereby forming a closed space inside the tube body for containing the urine to be tested;
    其中,所述隔膜为不透液体并且允许采样针穿过的膜状结构,并且具有悬滴样造型,所述的悬滴样造型选自下组:所述隔膜朝向管底下凹,或者隔膜朝向管口上凸。Wherein, the septum is a membrane-like structure that is liquid-tight and allows the sampling needle to pass through, and has a pendant drop-like shape, and the pendant drop-like shape is selected from the following group: the septum is concave toward the bottom of the tube, or the septum is concave toward the bottom of the tube The nozzle is convex.
  2. 如权利要求1所述的免开盖的一次性尿液采集管,其特征在于,所述的下凹的深度h 1的取值范围为2mm≤h 1≤6mm。 The disposable urine collection tube without opening the cap according to claim 1, characterized in that, the value range of the depth h 1 of the depression is 2 mm≤h 1 ≤6 mm.
  3. 如权利要求1所述的免开盖的一次性尿液采集管,其特征在于,所述的上凸的高度h 2的取值范围为2mm≤h 2≤6mm。 The disposable urine collection tube without opening the cap according to claim 1, characterized in that, the value range of the height h 2 of the upward protrusion is 2 mm≤h 2 ≤6 mm.
  4. 如权利要求1所述的免开盖的一次性尿液采集管,其特征在于,所述隔膜是固定设置于、附着于、或粘附于所述管盖。The disposable urine collection tube without opening the cap according to claim 1, wherein the septum is fixed on, attached to, or adhered to the tube cap.
  5. 如权利要求1所述的免开盖的一次性尿液采集管,其特征在于,所述隔膜的厚度为t,直径为d,t的取值范围0.3≤t≤3mm;d的取值范围8≤d≤25mm。The disposable urine collection tube without opening the cover according to claim 1, wherein the thickness of the diaphragm is t, the diameter is d, and the value range of t is 0.3≤t≤3mm; the value range of d 8≤d≤25mm.
  6. 如权利要求1所述的免开盖的一次性尿液采集管,其特征在于,所述免开盖的一次性尿液采集管的容量5-20ml。The disposable urine collection tube without opening cap according to claim 1, characterized in that the capacity of the disposable urine collection tube without opening cap is 5-20ml.
  7. 如权利要求1所述的免开盖的一次性尿液采集管,其特征在于,所述管盖与所述管体为可拆卸的螺纹连接。The disposable urine collection tube without opening the cap according to claim 1, characterized in that, the tube cap and the tube body are detachably threaded.
  8. 如权利要求1所述的免开盖的一次性尿液采集管,其特征在于, 所述管盖沿周向的外侧设置有一个或多个止动突,用于防止所述一次性尿液采集管横置在水平面上时的随意滚动。The disposable urine collection tube without opening the cover according to claim 1, wherein one or more stop protrusions are arranged on the outside of the tube cover along the circumferential direction to prevent the disposable urine from The free rolling of the collection tube when it is placed horizontally on the horizontal plane.
  9. 如权利要求1所述的免开盖的一次性尿液采集管,其特征在于,所述隔膜上允许采样针穿过的膜状结构为非贯通性切迹。The disposable urine collection tube without opening the cap according to claim 1, characterized in that the membrane-like structure on the septum that allows the sampling needle to pass through is a non-penetrating notch.
  10. 如权利要求9所述的免开盖的一次性尿液采集管,其特征在于,所述非贯通性切迹具有选自下组的一个或多个特征:The disposable urine collection tube without opening the cap according to claim 9, wherein the non-penetrating notch has one or more characteristics selected from the group below:
    (a)非贯通性切迹的厚度与隔膜的厚度比的取值范围为1%-10%;(a) The ratio of the thickness of the non-penetrating notch to the thickness of the diaphragm ranges from 1% to 10%;
    (b)未切穿的厚度的取值范围为0.005-0.3mm。(b) The value range of the uncut thickness is 0.005-0.3mm.
  11. 如权利要求5所述的免开盖的一次性尿液采集管,其特征在于,非贯通性切迹为“十”字形或者“丫”字形。The disposable urine collection tube without opening the cap according to claim 5, wherein the non-penetrating notch is in the shape of a "cross" or a "Y".
  12. 如权利要求1所述的免开盖的一次性尿液采集管,其特征在于,所述隔膜为软质可塑性材质。The disposable urine collection tube without opening the cap according to claim 1, wherein the diaphragm is made of soft plastic material.
  13. 如权利要求1所述的免开盖的一次性尿液采集管,其特征在于,所述管体底部的乳头底周围设置有多个加强筋。The disposable urine collection tube without opening the cap according to claim 1, wherein a plurality of reinforcing ribs are arranged around the bottom of the nipple at the bottom of the tube body.
  14. 如权利要求1所述的免开盖的一次性尿液采集管,其特征在于,所述一次性尿液采集管用于与自动尿液分析仪或自动尿沉渣分析仪适配,并且所述采样针为自动尿液分析仪的采样针或自动尿沉渣分析仪的采样针。The disposable urine collection tube without opening the cover according to claim 1, wherein the disposable urine collection tube is adapted to an automatic urine analyzer or an automatic urine sediment analyzer, and the sampling The needle is a sampling needle of an automatic urine analyzer or a sampling needle of an automatic urine sediment analyzer.
  15. 一种免开盖的一次性尿液采集管,其特征在于,包括:管盖、隔膜、和管体;A disposable urine collection tube without opening the cover, characterized in that it includes: a tube cover, a diaphragm, and a tube body;
    其中,当所述管盖与所述管体连接时,所述隔膜位于所述管体和所述管盖之间,从而在管体内部形成用于容纳待检尿液的密闭空间;Wherein, when the tube cover is connected with the tube body, the diaphragm is located between the tube body and the tube cover, thereby forming a closed space inside the tube body for containing the urine to be tested;
    其中,所述隔膜为不透液体并且允许采样针穿过的膜状结构,并且具有悬滴样造型,所述的悬滴样造型选自下组:所述隔膜朝向管底下凹,或 者隔膜朝向管口上凸,下凹部分或上凸部分的顶部具有穿刺表面,所述穿刺表面是平坦的,适配并允许采样针穿过。Wherein, the septum is a membrane-like structure that is liquid-tight and allows the sampling needle to pass through, and has a pendant drop-like shape, and the pendant drop-like shape is selected from the following group: the septum is concave toward the bottom of the tube, or the septum is concave toward the bottom of the tube The spout is convex, concave or the top of the convex portion has a piercing surface which is flat and fits and allows the sampling needle to pass through.
  16. 如权利要求15所述的免开盖的一次性尿液采集管,其特征在于,所述穿刺表面为圆形,所述圆形直径d s取值范围为0mm<d s≤10mm。 The disposable urine collection tube without opening cap according to claim 15, characterized in that, the puncture surface is circular, and the diameter d s of the circle is in the range of 0mm< ds≤10mm .
  17. 如权利要求15所述的免开盖的一次性尿液采集管,其特征在于,所述隔膜是固定设置于、附着于、或粘附于所述管盖。The disposable urine collection tube without opening the cap according to claim 15, wherein the septum is fixedly arranged on, attached to, or adhered to the tube cap.
  18. 如权利要求15所述的免开盖的一次性尿液采集管,其特征在于,所述下凹部分或所述上凸部分沿着外缘延伸至穿刺表面的方向,厚度递减。The disposable urine collection tube without opening the cap according to claim 15, characterized in that, the thickness of the concave part or the convex part is gradually reduced along the direction extending from the outer edge to the puncture surface.
  19. 如权利要求18所述的免开盖的一次性尿液采集管,其特征在于,下凹部分或所述上凸的部分的厚度为t 1,所述隔膜的所述穿刺表面厚度为t 2,其中, The disposable urine collection tube without opening the cap according to claim 18, wherein the thickness of the concave part or the convex part is t1 , and the thickness of the puncture surface of the diaphragm is t2 ,in,
    t 1的取值范围0.5mm≤t 1≤3mm;t 2的取值范围5μm≤d≤1mm。 The value range of t 1 is 0.5mm≤t 1 ≤3mm; the value range of t 2 is 5μm≤d≤1mm.
  20. 如权利要求15所述的免开盖的一次性尿液采集管,其特征在于,t 1与t 2的比值为δ,其中,δ的取值范围为2≤δ≤10 6The cap-free disposable urine collection tube according to claim 15, wherein the ratio of t 1 to t 2 is δ, wherein the range of δ is 2≤δ≤10 6 .
  21. 如权利要求20所述的免开盖的一次性尿液采集管,其特征在于,所述隔膜还包括:连接部,所述连接部的厚度为t 3,其中,t 3取值范围为0.5mm≤t 3≤3mm。 The disposable urine collection tube without opening the cover according to claim 20, wherein the diaphragm further comprises: a connecting part, the thickness of the connecting part is t3 , wherein the value range of t3 is 0.5 mm≤t 3 ≤3mm.
  22. 如权利要求15所述的免开盖的一次性尿液采集管,其特征在于,所述免开盖的一次性尿液采集管的容量5-20ml。The disposable urine collection tube without opening cap according to claim 15, characterized in that the capacity of the disposable urine collection tube without opening cap is 5-20ml.
  23. 如权利要求22所述的免开盖的一次性尿液采集管,其特征在于,所述管盖与所述管体为可拆卸的螺纹连接。The disposable urine collection tube without opening the cap according to claim 22, wherein the tube cap and the tube body are detachably threaded.
  24. 如权利要求23所述的免开盖的一次性尿液采集管,其特征在于,所述连接部上设置有螺纹,所述连接部配置为与所述管体实现所述螺纹连 接。The disposable urine collection tube without opening the cap according to claim 23, characterized in that, the connecting part is provided with threads, and the connecting part is configured to realize the threaded connection with the tube body.
  25. 如权利要求15所述的免开盖的一次性尿液采集管,其特征在于,所述管盖沿周向的外侧设置有一个或多个止动突,用于防止所述一次性尿液采集管横置在水平面上时的随意滚动。The disposable urine collection tube without opening the cover according to claim 15, characterized in that, one or more stop protrusions are arranged on the outer side of the tube cover along the circumferential direction to prevent the disposable urine from The free rolling of the collection tube when it is placed horizontally on the horizontal plane.
  26. 如权利要求24所述的免开盖的一次性尿液采集管,其特征在于,所述隔膜上具有辅助采样针穿过的膜状结构的非贯通性切迹,所述非贯通切迹沿着所述平坦表面的圆周均布,所述非贯通性切迹从所述隔膜的外缘延伸至平穿刺表面外缘,所述非贯通切迹根数为n,n取值范围为0≤n≤6。The disposable urine collection tube without opening the cap according to claim 24, wherein the septum has a non-penetrating notch of a membranous structure that assists the sampling needle to pass through, and the non-penetrating notch is along the The circumference of the flat surface is evenly distributed, the non-penetrating notch extends from the outer edge of the septum to the outer edge of the flat puncture surface, the number of the non-penetrating notch is n, and the value range of n is 0≤ n≤6.
  27. 如权利要求26所述的免开盖的一次性尿液采集管,其特征在于,所述非贯通性切迹具有选自下组的一个或多个特征:The disposable urine collection tube without opening the cap according to claim 26, wherein the non-penetrating notch has one or more characteristics selected from the following group:
    (a)非贯通性切迹的厚度与隔膜的厚度比的取值范围为1%-10%;(a) The ratio of the thickness of the non-penetrating notch to the thickness of the diaphragm ranges from 1% to 10%;
    (b)未切穿的厚度的取值范围为0.005-0.3mm。(b) The value range of the uncut thickness is 0.005-0.3mm.
  28. 如权利要求26所述的免开盖的一次性尿液采集管,其特征在于,所述穿刺表面距离管口的高度h 3的取值范围为:2mm≤h 3≤4mm。 The disposable urine collection tube without opening the cap according to claim 26, wherein the value range of the height h 3 from the puncture surface to the mouth of the tube is: 2mm≤h3≤4mm .
  29. 如权利要求15所述的免开盖的一次性尿液采集管,其特征在于,所述隔膜为软质可塑性材质。The disposable urine collection tube without opening the cap according to claim 15, wherein the diaphragm is made of soft plastic material.
  30. 如权利要求15所述的免开盖的一次性尿液采集管,其特征在于,所述管体底部的乳头底周围设置有多个加强筋。The disposable urine collection tube without opening the cap according to claim 15, wherein a plurality of reinforcing ribs are arranged around the bottom of the nipple at the bottom of the tube body.
  31. 如权利要求15所述的免开盖的一次性尿液采集管,其特征在于,所述一次性尿液采集管用于与自动尿液分析仪或自动尿沉渣分析仪适配,并且所述采样针为自动尿液分析仪的采样针或自动尿沉渣分析仪的采样针。The disposable urine collection tube without opening the cover according to claim 15, wherein the disposable urine collection tube is adapted to an automatic urine analyzer or an automatic urine sediment analyzer, and the sampling The needle is a sampling needle of an automatic urine analyzer or a sampling needle of an automatic urine sediment analyzer.
PCT/CN2022/074408 2021-08-23 2022-01-27 Disposable urine collection tube without need to be uncapped WO2023024434A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202121985998.7 2021-08-23
CN202121985998.7U CN215833074U (en) 2021-08-23 2021-08-23 Disposable urine collecting pipe without opening cover
CN202123442803.7U CN216955333U (en) 2021-12-31 2021-12-31 Disposable urine collecting tube without opening cover
CN202123442803.7 2021-12-31

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005172682A (en) * 2003-12-12 2005-06-30 Fukae Chemical Research:Kk Sample storing tube
CN205288460U (en) * 2015-10-13 2016-06-08 无锡市凯顺医疗器械制造有限公司 Ware is kept somewhere to disposable airtight body fluid of portable
CN211347552U (en) * 2019-12-17 2020-08-25 中日友好医院 Urine collecting tube
CN211936980U (en) * 2020-03-18 2020-11-17 迪瑞医疗科技股份有限公司 Closed urine test tube
CN212092336U (en) * 2020-03-18 2020-12-08 迪瑞医疗科技股份有限公司 Closed urine test tube
CN212364302U (en) * 2020-03-16 2021-01-15 浙江拱东医疗器械股份有限公司 Automatic operating detection self-sealing urine measuring tube

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005172682A (en) * 2003-12-12 2005-06-30 Fukae Chemical Research:Kk Sample storing tube
CN205288460U (en) * 2015-10-13 2016-06-08 无锡市凯顺医疗器械制造有限公司 Ware is kept somewhere to disposable airtight body fluid of portable
CN211347552U (en) * 2019-12-17 2020-08-25 中日友好医院 Urine collecting tube
CN212364302U (en) * 2020-03-16 2021-01-15 浙江拱东医疗器械股份有限公司 Automatic operating detection self-sealing urine measuring tube
CN211936980U (en) * 2020-03-18 2020-11-17 迪瑞医疗科技股份有限公司 Closed urine test tube
CN212092336U (en) * 2020-03-18 2020-12-08 迪瑞医疗科技股份有限公司 Closed urine test tube

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