WO2023024434A1 - Tube de collecte d'urine jetable sans besoin d'ouverture - Google Patents

Tube de collecte d'urine jetable sans besoin d'ouverture 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
Application number
PCT/CN2022/074408
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English (en)
Chinese (zh)
Inventor
武楠
Original Assignee
上海蜚誉生物科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202121985998.7U external-priority patent/CN215833074U/zh
Priority claimed from CN202123442803.7U external-priority patent/CN216955333U/zh
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/fr

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state

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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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hydrology & Water Resources (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Clinical Laboratory Science (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Tube de collecte d'urine jetable sans besoin d'ouverture, comprenant un capuchon de tube (10), une membrane (40) et un corps de tube (30). Lorsque le capuchon de tube (10) est relié au corps de tube (30), la membrane (40) est située entre le corps de tube (30) et le capuchon de tube (10), de telle sorte qu'un espace fermé permettant de contenir l'urine à analyser est formé dans le corps de tube (30); et la membrane (40) constitue une structure de type membrane étanche aux liquides et permet à une aiguille d'échantillonnage de pénétrer à travers cette dernière, et présente une forme de goutte en suspension sélectionnée parmi la membrane (40) concave vers le fond du tube ou la membrane (40) convexe vers l'ouverture du tube. La partie supérieure de la partie concave ou de la partie convexe (401) peut présenter une surface de perforation (402), et la surface de perforation (402) est plate, et est adaptée à l'aiguille d'échantillonnage afin de lui permettre de pénétrer à travers cette dernière. Lorsque le tube d'échantillonnage est utilisé pour analyser l'urine à analyser, l'aiguille d'échantillonnage d'analyse pénètre directement dans la membrane (40) afin d'échantillonner l'urine à analyser sans ouvrir le capuchon de tube (10). De plus, le tube de collecte est adapté à différentes aiguilles d'échantillonnage afin de pénétrer dans cette dernière.
PCT/CN2022/074408 2021-08-23 2022-01-27 Tube de collecte d'urine jetable sans besoin d'ouverture WO2023024434A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202121985998.7U CN215833074U (zh) 2021-08-23 2021-08-23 一种免开盖的一次性尿液收集管
CN202121985998.7 2021-08-23
CN202123442803.7 2021-12-31
CN202123442803.7U CN216955333U (zh) 2021-12-31 2021-12-31 一种免开盖的一次性尿液采集管

Publications (1)

Publication Number Publication Date
WO2023024434A1 true WO2023024434A1 (fr) 2023-03-02

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WO (1) WO2023024434A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005172682A (ja) * 2003-12-12 2005-06-30 Fukae Chemical Research:Kk 試料収納用チューブ
CN205288460U (zh) * 2015-10-13 2016-06-08 无锡市凯顺医疗器械制造有限公司 一种便捷式一次性密闭体液留置器
CN211347552U (zh) * 2019-12-17 2020-08-25 中日友好医院 一种尿液采集管
CN211936980U (zh) * 2020-03-18 2020-11-17 迪瑞医疗科技股份有限公司 一种封闭式尿液试管
CN212092336U (zh) * 2020-03-18 2020-12-08 迪瑞医疗科技股份有限公司 一种封闭式尿液试管
CN212364302U (zh) * 2020-03-16 2021-01-15 浙江拱东医疗器械股份有限公司 一种自动上机检测自封式尿测定管

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005172682A (ja) * 2003-12-12 2005-06-30 Fukae Chemical Research:Kk 試料収納用チューブ
CN205288460U (zh) * 2015-10-13 2016-06-08 无锡市凯顺医疗器械制造有限公司 一种便捷式一次性密闭体液留置器
CN211347552U (zh) * 2019-12-17 2020-08-25 中日友好医院 一种尿液采集管
CN212364302U (zh) * 2020-03-16 2021-01-15 浙江拱东医疗器械股份有限公司 一种自动上机检测自封式尿测定管
CN211936980U (zh) * 2020-03-18 2020-11-17 迪瑞医疗科技股份有限公司 一种封闭式尿液试管
CN212092336U (zh) * 2020-03-18 2020-12-08 迪瑞医疗科技股份有限公司 一种封闭式尿液试管

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