WO2023029054A1 - 采集总成 - Google Patents

采集总成 Download PDF

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Publication number
WO2023029054A1
WO2023029054A1 PCT/CN2021/116784 CN2021116784W WO2023029054A1 WO 2023029054 A1 WO2023029054 A1 WO 2023029054A1 CN 2021116784 W CN2021116784 W CN 2021116784W WO 2023029054 A1 WO2023029054 A1 WO 2023029054A1
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WO
WIPO (PCT)
Prior art keywords
sampling
sampling tube
tube
cavity
chamber
Prior art date
Application number
PCT/CN2021/116784
Other languages
English (en)
French (fr)
Inventor
杨圣武
马湖波
刘文胜
林永伟
吴述
多明格斯·艾莉森·费雷拉
郑维俊
库比·阿皮亚
克罗斯利·彼得
莫恩德·亚历克斯
马洛伊·安德鲁
帕特森·威廉
Original Assignee
皮乐迪有限公司
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
Application filed by 皮乐迪有限公司 filed Critical 皮乐迪有限公司
Priority to PCT/CN2021/116784 priority Critical patent/WO2023029054A1/zh
Publication of WO2023029054A1 publication Critical patent/WO2023029054A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers

Definitions

  • the present application relates to the field of medical devices, in particular to a collection assembly.
  • the sample needs to be transported and cultured, and the process of sample transport and culture needs to be kept completely sealed to avoid environmental pollution, and the airtightness of the sampling tube and the detection tube is particularly important.
  • the transfer method through the dropper in the prior art is slow and inefficient, and it is difficult to reliably complete large-scale testing and testing.
  • the process is accompanied by certain risks.
  • one purpose of the present application is to propose a collection assembly, which is less difficult to operate, more convenient for sample transfer, and greatly improves the efficiency and safety of sample transfer.
  • the collection assembly includes: a sampling tube, a sample containing cavity is arranged in the sampling tube; a detection tube, a sampling cavity suitable for accommodating the sampling tube is arranged in the detection tube, and the bottom wall of the sampling cavity A reagent reaction chamber is formed, a needle is arranged on the bottom wall of the sampling chamber, and a liquid guide channel is formed inside the needle, and the needle is suitable for being inserted into the sample holding chamber so that the liquid guide channel
  • the sampling chamber communicates with the reagent reaction chamber.
  • the sampling tube is used to collect the reagent
  • the detection tube is used to carry the sampling tube
  • the reagent in the sampling tube is introduced into the reagent reaction chamber using the internal needle to complete the detection of the sample. Detection, the flow of the medium in the sampling tube during the transfer process is stable and reliable, the sealing is good, the safety is high, the operation difficulty of the collection assembly is low, and the transfer efficiency is high.
  • the sampling tube is provided with a matching part
  • the detecting tube is provided with a stopper that cooperates with the matching part
  • the stopper is suitable for inserting the needle into the When the sample holding cavity or the sampling tube contacts the bottom wall of the sampling cavity, it cooperates with the matching part to limit the movement of the sampling tube.
  • the limiter includes: a first limiter and a second limiter, the first limiter and the second limiter are in the insertion direction of the sampling tube
  • the inner circumference of the sampling chamber is arranged at intervals in sequence; wherein the first stopper is adapted to engage with the sampling tube when the needle enters the sampling tube to limit the detachment of the sampling tube; the second The two stoppers are adapted to limit the sampling tube from detachment when the sampling tube is in contact with the bottom wall of the sampling chamber.
  • the matching portion is configured as an annular rib protruding from the outer peripheral wall of the sampling tube body; both the first limiting member and the second limiting member are configured as at least partially convex Out of the raised portion of the inner wall of the sampling chamber.
  • the sampling tube is provided with a cover
  • the sampling tube is provided with a reagent input port communicating with the sample holding chamber
  • the sampling tube is provided with a cover
  • the cover is reversible It is arranged on the upper end of the sampling tube to selectively close the reagent injection port
  • the sampling tube is formed with a first clamping part
  • the cover is formed with a first clamping part matched with the first clamping part. Two clamping parts.
  • the sampling tube when the sampling tube is in contact with the bottom wall of the sampling cavity, at least part of the peripheral wall of the sampling cavity is facing the second locking part.
  • the first clamping part is configured as a clamping notch formed on the outer peripheral wall of the sampling tube body, and the second clamping part is configured as a clamping gap formed on the cover.
  • a ring, at least part of the fastening ring is embedded in the fastening notch.
  • a guiding cavity suitable for guiding the needle is formed in the sampling tube, a first sealing ring is arranged in the guiding cavity, and the first sealing ring is suitable for connecting with the needle
  • the outer periphery of the sampling tube is provided with a second sealing ring, and the second sealing ring is arranged between the outer peripheral wall of the sampling tube and the inner peripheral wall of the sampling cavity.
  • the outer circumference of the detection tube is provided with a radially protruding positioning member.
  • Fig. 1 is a schematic structural diagram of a sampling assembly according to an embodiment of the present application
  • Fig. 2 is an exploded view of a sampling assembly according to an embodiment of the present application
  • FIG. 3 is a top view of a sampling assembly according to an embodiment of the present application.
  • Fig. 4 is the sectional view of A-A section among Fig. 3;
  • Fig. 5 is a schematic structural diagram of an inverted detection tube according to an embodiment of the present application.
  • FIG. 6 is a top view of a detection tube according to an embodiment of the present application.
  • Fig. 7 is the sectional view of B-B section among Fig. 2;
  • FIG. 8 is a side view of a detection tube according to an embodiment of the present application.
  • FIG. 9 is a schematic diagram of a lateral structure of a detection tube according to an embodiment of the present application.
  • Fig. 10 is a schematic diagram of the bottom structure of a detection tube according to an embodiment of the present application.
  • Fig. 11 is an exploded view of a detection tube according to an embodiment of the present application.
  • FIG. 12 is a schematic structural view of a sampling tube body according to an embodiment of the present application.
  • Figure 13 is a schematic structural view of a sampling tube according to an embodiment of the present application.
  • FIG. 14 is a top view of a sampling tube according to an embodiment of the present application.
  • Fig. 15 is a sectional view of the C-C section in Fig. 14;
  • Fig. 16 is a schematic structural diagram of a support shell according to an embodiment of the present application.
  • Fig. 17 is a sectional view of the D-D section in Fig. 16 .
  • Sampling tube body 11 sample holding cavity 111, input port 111a, communication port 111b, guiding cavity 112, guiding flute 113, clamping notch 113a, annular clamping rib 114, annular convex rib 115,
  • Cover body 12 snap ring 121, sealing cylinder 122,
  • the first sealing film 101 and the second sealing film 102 are identical to each other.
  • the detection tube body 21 the bottom wall part 211, the light entrance position 2111, the light exit position 2112, the first prism 2113, the second prism 2114,
  • peripheral wall portion 212
  • Hydrophobic gas-permeable film 24 heat-sealing film 25, positioning piece 26.
  • the acquisition assembly 100 according to the embodiment of the present application will be described below with reference to FIGS. 1-17 .
  • the collection assembly 100 includes a sampling tube 1 and a detection tube 2.
  • the sampling tube 1 is provided with a sample containing cavity 111.
  • the detection tube 2 is provided with a sampling cavity suitable for accommodating the sampling tube 1.
  • the bottom wall of the sampling cavity A reagent reaction chamber 23 is formed, a needle 22 is arranged on the bottom wall of the sampling chamber, and a liquid guiding channel 220 is formed inside the needle 22, and the needle 22 is suitable for being inserted into the sample holding chamber so that the liquid guiding channel 220 reacts the sampling chamber with the reagent
  • the cavity 23 communicates.
  • the sampling tube 1 is provided with a sample holding chamber 111, in which a carrier medium for detection can be stored, for example, the sample holding chamber 111 can be used to hold enzyme-free water.
  • the sample holding chamber 111 is sealed to maintain the sealed environment in the sampling tube body 11. After the cotton swab has finished sampling, the sample holding chamber 111 The sealing film on the top is uncovered, so that the cotton swab with the sample is put into the sample holding chamber 111, and the sample is dissolved in the medium.
  • the sampling tube 1 after sampling is accommodated in the sampling cavity.
  • the needle 22 will pierce the inside of the sampling tube 1, and the liquid guide channel 220 in the needle 22 will be used to bring the inside of the sampling tube 1
  • the medium of the sample to be detected is introduced into the reagent reaction chamber 23 in the bottom wall of the detection tube body 21, the sample can react with the reagent stored in the reagent reaction chamber 23, and the detection result of the sample can be judged according to the state of the reagent after the reaction is completed .
  • the sample needs to be transported and cultured, and the process of sample transport and culture needs to be kept completely sealed to avoid environmental pollution, and the airtightness of the sampling tube and the detection tube is particularly important.
  • the transfer method through the dropper in the prior art is slow and inefficient, and it is difficult to reliably complete large-scale testing and testing.
  • the process is accompanied by certain risks.
  • the applicant starts with the detection device and improves it, aiming to create a new type of detection device to reduce the difficulty of transfer and improve the transfer efficiency.
  • the sampling tube 1 is kept in a sealed state and put into the sampling chamber in the detection tube body 21 to ensure that the sampling tube 1 remains in a sealed state throughout the transfer process, reducing environmental pollution and improving safety.
  • the detection tube 2 is provided with a reagent reaction chamber 23 on the bottom wall of the sampling chamber and a needle 22 for piercing the sampling tube 1 on the inner wall of the sampling chamber, so that the sampling tube 1 is accommodated in the sampling chamber,
  • the needle 22 pierces the inside of the sampling tube 1 to transport the sample-carrying medium inside the sampling tube 1 to the reagent reaction chamber 23 through the guide channel 220 to react the sample and complete the final detection.
  • both the transfer of the sample and the detection of the sample occur in the detection tube 2, and there is no need to use other instruments to operate the medium in the sampling tube 1, which reduces the contact between the sample and the air and improves the detection efficiency.
  • the reliability of the tube 2 for sample detection, and the cooperation between the detection tube 2 and the sampling tube 1 is simple and reliable, and the transfer efficiency of the sample is high.
  • the sampling tube 1 includes a sampling tube body 11, and a sample holding cavity 111 and a guiding cavity 112 are formed in the sampling tube body 11, and both ends of the sample holding cavity 111 are opened to form
  • the insertion port 111a and the communication port 111b, the guide cavity 112 is disposed at the downstream end of the communication port 111b and is suitable for guiding the needle 22 inserted into the sample containing cavity 111 .
  • one end of the sample holding chamber 111 in the sampling tube 1 is provided with a delivery port 111a, and the user can put in a cotton swab after sampling through the delivery port 111a, while the other end of the sampling tube 1 can be provided with a
  • the guide cavity 112 can easily penetrate the needle 22 to ensure that the needle 22 is pierced
  • the sealing performance of the sampling tube 1 improves the safety and reliability of the transfer process.
  • the sampling tube 1 is provided with a matching part, and the detection tube 2 is provided with a stopper that cooperates with the matching part.
  • the detection tube 2 is provided with a stopper that cooperates with the matching part.
  • the detection tube body 21 includes a bottom wall portion 211 and a peripheral wall portion 212, the bottom wall portion 211 is provided with a reagent reaction chamber 23, and the peripheral wall portion 212 is disposed on the bottom wall.
  • the outer peripheral edge of the portion 211 and the bottom wall portion 211 define a sampling cavity, and the peripheral wall portion 212 is provided with a limiting member for limiting the separation of the sampling tube 1 .
  • the bottom wall 211 and the peripheral wall 212 define a sampling chamber for accommodating the sampling tube 1, the bottom wall 211 may be provided with a needle 22 for piercing the sampling tube 1, and a limiting member is provided on the peripheral wall 212 to limit
  • the position piece can be used to restrict the sampling tube 1 from the sampling chamber after the needle 22 pierces the sampling tube 1, so that after the needle 22 pierces the sampling tube 1, the sampling tube 1 is restricted from being separated from the needle 22, so as to ensure that the needle 22 punctures the sampling tube 1
  • the sealed environment inside the sampling tube 1 is kept to avoid contact between the medium and the air in the environment, thereby improving the reliability of the transfer process.
  • the limiter can also be used to limit the movement of the sampling tube 1 after the sampling tube 1 is fully inserted into the sampling cavity, so as to ensure the reliability of the flow of the medium in the sampling tube 1 .
  • the setting of the limiter enables the detection tube 2 to be used only once. After the limiter cooperates with the matching part on the sampling tube 1, it cannot be reused except for destroying the detection tube 2 or the sampling tube 1, which also ensures that the detection tube 2 Medical safety with sampling tube 1.
  • the sampling tube 1 is used to collect reagents
  • the detection tube 2 is used to carry the sampling tube 1
  • the reagent in the sampling tube 1 is collected by the internal needle 22. Introduced into the reagent reaction chamber 23 to complete the detection of the sample, the flow of the medium in the sampling tube 1 during the transfer process is stable and reliable, with good sealing and high safety, the operation difficulty of the collection assembly 100 is low, and the transfer efficiency is high.
  • the limiter includes a first limiter 2121 and a second limiter 2122, and the first limiter 2121 and the second limiter 2122 are sequentially arranged at intervals in the insertion direction of the sampling tube 1 on the inner periphery of the sampling chamber.
  • the first limiter 2121 is adapted to engage with the sampling tube 1 when the needle 22 enters the sampling tube 1 to limit the disengagement of the sampling tube 1;
  • the second limiter 2122 is suitable for when the sampling tube 1 is in contact with the bottom wall of the sampling chamber Restricted sampling line 1 from detaching.
  • the needle 22 When the sampling tube 1 is inserted into the sampling cavity, the needle 22 will first puncture the sampling tube 1, and the sampling tube 1 can still continue to move to the bottom of the sampling cavity.
  • the positions of the first limiter 2121 and the second limiter 2122 are arranged sequentially in the insertion direction of the sampling tube 1, and the first limiter 2121 is suitable for clamping with the sampling tube 1 when the needle 22 enters the sampling tube 1 to limit Sampling tube 1 is detached.
  • the second stopper 2122 is suitable for cooperating with the sampling tube 1 when the sampling tube 1 is in contact with the bottom wall of the sampling cavity, so as to limit the sampling tube 1 from being separated from the sampler. cavity, and the second stopper 2122 is suitable for maintaining the stability of the sampling tube 1, so as to ensure that the sampling tube 1 cannot be separated from the sampling cavity during the detection process of the sampling tube 1.
  • the peripheral wall portion 212 is provided with a first fitting hole 2101, the first fitting hole 2101 extends in the same direction as the detection tube body 21, and the second fitting hole 2102 is far from
  • a first limiting member 2121 is disposed on a side edge of the bottom wall portion 211 , and a first protrusion 2121 a protruding toward the sampling chamber is formed at a free end of the first limiting member 2121 .
  • the outer circumference of the sampling tube 1 is provided with a matching portion, and the matching portion is configured as an annular rib 115 formed on the outer circumference of the lower end of the sampling tube 1, and the upper end surface of the annular rib 115 is a plane to be suitable for matching with the first limit position.
  • the first protruding portion 2121a provided on the component 2121 stops against it, and the first protruding portion 2121a is adapted to limit the movement of the annular rib 115 toward the pulling out direction.
  • the peripheral wall portion 212 is provided with a second fitting hole 2102, the second fitting hole 2102 extends in the same direction as the detection tube body 21, and the side edge of the second fitting hole 2102 away from the bottom wall portion 211 is provided.
  • the upper end surface of the annular rib 115 is flat so as to be suitable for abutting against the second protrusion 2122a provided on the second limiting member 2122, and the second protrusion 2122a is adapted to limit the movement of the annular rib 115 toward the pulling out direction .
  • the positions of the first protruding portion 2121a and the second protruding portion 2122a are sequentially arranged in the insertion direction of the sampling tube 1, and the first protruding portion 2121a is suitable for matching with the matching portion after the needle 22 punctures the sampling tube 1. Clamping, the second protruding part 2122a is suitable for clamping with the matching part after the sampling tube 1 is fully inserted into the sampling cavity.
  • the sampling tube 1 is also provided with a reagent injection port communicated with the sample holding chamber, the sampling tube is provided with a cover 12, and the cover 12 is reversibly arranged on the sampling tube
  • the upper end of the body 11 can selectively close the insertion port 111a.
  • the sampling tube body 11 is formed with a first clamping portion, and the cover 12 is formed with a second clamping portion that cooperates with the first clamping portion.
  • the membrane rear inlet 111a is in an open state, and the lid 12 is used to close the inlet 111a, so that the sample holding chamber 111 becomes a sealed space.
  • the carrier medium is fully contacted with the cotton swab that has been sampled by shaking the sampling tube 1.
  • the cover body 12 can keep the airtightness in the sample holding chamber 111 after the sampling is completed, so as to avoid contamination of the sample during transport.
  • the sampling tube body 11 is provided with a first clamping part
  • the cover 12 is provided with a second clamping part
  • the first clamping part cooperates with the second clamping part to prevent the cover 12 from being accidentally opened.
  • a certain pressure can be generated between the cover body 12 and the edge of the insertion port 111a, ensuring the airtightness of the sample receiving chamber 111 after the cover body 12 closes the insertion port 111a.
  • the cover body 12 is provided with a sealing cylinder 122 protruding in the axial direction.
  • a sealing cylinder 122 protruding in the axial direction.
  • a protrusion is provided on the outer periphery of the sealing cylinder 122, so that the sealing cylinder 122 can have an interference fit with the insertion port 111a.
  • a sealing member is provided on the inner peripheral wall of the delivery port 111a, and the sealing member is configured as a rubber member. Further improve the sealing effect.
  • a sealing member is provided on the outer periphery of the sealing cylinder 122, and the sealing member is configured as a rubber member, so that the sealing member can further improve the sealing performance of the sealing cover.
  • the first locking portion is configured as a locking notch 113a formed on the peripheral wall of the sampling tube 1
  • the second locking portion is configured as a locking portion formed on the cover 12 .
  • the ring 121 is at least partially embedded in the snapping notch 113a. The cooperation between the snap ring 121 and the snap notch 113a is used to realize the stability of the cover body 12 in the state of closing the insertion port 111a and improve the sealing performance of the sampling tube 1 .
  • the outer circumference of the sampling tube body 11 is provided with a plurality of guide ribs 113 arranged at intervals.
  • the guide ribs 113 protrude in the radial direction of the sampling tube body 11 and extend in the axial direction. Any two symmetrical
  • the upper end of the guide flute 113 is provided with a locking notch 113 a, and correspondingly, two locking rings 121 are configured and symmetrically arranged on the outer periphery of the cover body 12 .
  • the outer circumference of the sampling tube body 11 is provided with a guide flute 113, which can position the sampling tube 1 in the circumferential direction when the sampling tube 1 is accommodated in the detection tube 2, thereby avoiding the rotation of the sampling tube 1, and can also use the guide flute 113 to raise the sampling tube. 1 to better protect the carrier medium inside the sampling tube 1.
  • the upper end of the guide flute 113 is provided with a snap-fit notch 113a, and a snap-fit ring 121 is correspondingly provided on the cover body 12.
  • the snap-fit ring 121 is turned over to the side of the sampling tube body 11, and the snap-fit ring At least part of the ring 121 is facing the snap-fit notch 113a.
  • the sealing cylinder 122 on the cover body 12 extends into the insertion port 111a, at least part of the snap-fit ring 121 is also embedded in the snap-fit notch 113a at the same time to realize the cover. Fixing of the body 12.
  • two snap rings 121 are constructed symmetrically, and the symmetrical centerlines of the two snap rings 121 pass through the hinge point where the cover 12 is opposite to the sampling tube body 11, and the cover 12 and the sampling tube
  • the main body 11 is connected by a hinge point, and the cover body 12 is connected to the sampling tube body 11 through two snap rings 121 and the hinge point, and the above three positions can ensure that the pressure distributed on the cover body 12 is even, so as to improve The sealing effect of the cover body 12 on the insertion port 111a.
  • the peripheral wall of the sampling chamber is used to limit the movement of the second clamping part, so as to avoid accidental opening of the cover 12 and ensure the reliability of the sampling tube 1 and the detection tube 2 after cooperation.
  • the sampling tube 1 further includes a first sealing ring 13, the first sealing ring 13 is disposed in the guide cavity 112 and is suitable for abutting against the outer peripheral wall of the needle 22, and when the needle 22 penetrates the first During the process of sealing the film 101, there is ambient gas in the guide cavity 112. In order to ensure that the needle 22 will not be polluted by the gas in the environment during the insertion process, it is necessary to ensure that the needle 22 is sealed and isolated from the external ambient gas when it is inserted. enclosed space.
  • the first sealing ring 13 can be arranged adjacent to the first sealing film 101, preferably against the first sealing film 101. When the needle 22 enters the guide cavity 112, the needle 22 needs to pass through the first sealing ring 13.
  • a sealing ring 13 abuts against the outer peripheral wall of the needle 22 to form a relatively airtight chamber between the first sealing ring 13 and the first sealing film 101, so that when the needle 22 penetrates the first sealing film 101 , greatly reducing the possibility of the external environment polluting the needle 22 and the sample in the sample holding chamber 111, and further improving the reliability of sample detection.
  • the sampling tube 1 further includes a second sealing ring 14, the second sealing ring 14 is arranged on the outer periphery of the sampling tube body 11, and the sampling tube 1 needs to be inserted into the detection tube 2 for For sample detection, a sampling cavity is provided in the detection tube 2.
  • the process of the sampling tube 1 entering the sampling cavity needs to be further sealed to ensure that there will be no air pollution when the needle 22 pierces the first sealing film 101 carrier medium.
  • the second sealing ring 14 is arranged on the outer periphery of the sampling tube body 11, which can stop against the inner wall of the sampling cavity when the sampling tube 1 enters the sampling cavity, thereby forming a relatively sealed chamber at the bottom of the sampling cavity, greatly reducing the external environment.
  • the possibility of contaminating the needle 22 and the sample in the sample holding chamber 111 further improves the reliability of sample detection.
  • the sampling tube 1 further includes a support shell 15, and the support shell 15 includes a bottom shell 151, and the bottom shell 151 is provided with a connecting passage facing the guide cavity 112
  • the hole is connected to the through hole suitable for the passage of the needle head 22 so as to penetrate the first sealing film 101 after passing through the guide cavity 112.
  • the outer periphery of the bottom shell 151 is also provided with a support plate 152.
  • the support plate 152 extends toward a direction away from the bottom shell 151 and The free end abuts against the second sealing ring 14 , wherein the bottom shell 151 or the support plate 152 is fixedly connected with the sampling tube body 11 .
  • the support shell 15 is used to support the second seal ring 14. After the bottom shell 151 and the support plate 152 are fixed relative to the sampling tube body 11, the support plate 152 can be used to limit the movement of the second seal ring 14 in one direction. When the sealing ring 14 is in contact with the inner peripheral wall of the sampling chamber, the second sealing ring 14 needs to bear frictional force. In order to prevent the second sealing ring 14 from moving and twisting to cause sealing failure, the supporting shell 15 and the second sealing ring 14 are stopped to The movement of the second sealing ring 14 is restricted to ensure that the sealing of the second sealing ring 14 is stable when the sampling tube 1 enters the sampling cavity.
  • a stepped portion for limiting the movement of the second sealing ring 14 in another direction is also formed on the outer peripheral wall of the sampling tube body 11, the stepped portion stops against the upper side of the second sealing ring 14, and the support plate 152 supports on the lower side of the second sealing ring 14.
  • a third clamping portion is provided on one of the support plate 152 and the outer peripheral wall of the sampling tube body 11 , and the other of the supporting plate 152 and the outer peripheral wall of the sampling tube body 11
  • a fourth clamping part is provided on it, specifically, an annular clamping groove 1521 is provided on the inner peripheral wall of the support plate 152 , and an annular clamping rib 114 matching the circular clamping groove 1521 is provided on the outer periphery of the sampling tube body 11 .
  • the bottom shell 151 is provided with a positioning cylinder 1511 extending toward the inside of the guide cavity 112 , and the free end of the positioning cylinder 1511 is directly opposite to the first sealing ring 13 , so as to Limit the movement of the first sealing ring 13.
  • the outer peripheral wall of the positioning cylinder 1511 can cooperate with the inner peripheral wall of the guide cavity 112 to position the bottom shell 151, so as to ensure that the position of the bottom shell 151 will not be eccentric relative to the sampling tube body 11.
  • a connecting through hole is formed in the positioning cylinder 1511 .
  • At least part of the end surface of the needle 22 is recessed to form an exhaust groove 221, and at least one end of the exhaust groove 221 is opened on the circumferential side wall of the needle 22.
  • the needle 22 can reduce the amount of gas sucked into the fluid system when the needle 22 pierces the fluid system, and at the puncture point of the sealing film, minimize the gap between the holes formed after the needle 22 pierces the sealing film. Utilizing the exhaust groove 221 formed on the end surface of the needle 22, and designing the end of the needle 22 as a concave shape, the air can be discharged during the puncture of the needle 22, thereby greatly reducing the passage of air through the liquid guide channel 220 into the reagent reaction chamber 23.
  • the end surface of the needle 22 is configured as an arc surface, a broken line surface or a hyperbolic paraboloid.
  • the end surface of the needle 22 is configured as a hyperbolic paraboloid, and the two concave ends of the hyperbolic paraboloid form an exhaust port 222, and the outer periphery of the end surface of the needle 22 is formed with convex edges facing each other. , the ribbed edge is used to pierce the sealing film on the sampling tube 1 .
  • the exhaust port 222 is formed with a chamfer 223, and the chamfer 223 formed at the exhaust port 222 can further increase the size of the exhaust port 222, and improve the exhaust when the needle 22 pierces the sealing film. Gas effect to further reduce the possibility of gas entering the reagent reaction chamber 23.
  • the reagent reaction chamber 23 includes a collection chamber 231 and a reagent chamber 232, the collection chamber 231 communicates with the other end of the liquid guiding channel 220, and the reagent chamber 232 is suitable for containing reagents and communicate with the collection cavity 231 .
  • the collection chamber 231 is used to collect the medium from the liquid guiding channel 220 , and after the collection of the medium is completed, it is introduced into the reagent chamber 232 and reacts with the reagent in the reagent chamber 232 .
  • the lower end of the bottom wall portion 211 forms a collecting groove, which is arranged at the center of the bottom wall portion 211 and faces the liquid guide channel 220 of the needle 22, and the lower end of the bottom wall portion 211 also A reagent tank is formed, and the reagent tank communicates with the collection tank through the flow channel groove.
  • a heat-sealing film 25 is provided at the lower end of the bottom wall portion 211 , and the collection chamber and the reagent chamber are sealed by the heat-sealing film 25 to form a reagent chamber 232 and a collection chamber 231 .
  • the reagent tank is configured as a through groove that penetrates the bottom wall 211 in the thickness direction, and a hydrophobic and gas-permeable film 24 is arranged on the top surface of the bottom wall 211, and the heat-sealing film 25 and the hydrophobic and gas-permeable film 24 are shared. Used to seal the reagent reservoir to form a reagent chamber 232 .
  • reagent chambers 232 there are multiple reagent chambers 232 , and an infusion channel 234 is provided between each reagent chamber 232 and the collection chamber 231 , and the infusion channel 234 bends and extends between the collection chamber 231 and the reagent chamber 232 .
  • the reagent chamber 232 is constructed in multiples to accommodate multiple groups of reagents, the reagents in each reagent chamber 232 can be the same or different, the same reagent can be used for a control test, and different reagents can be used for the same sample. Different types of tests.
  • An infusion channel 234 is provided between the reagent chamber 232 and the pooling chamber 231, and the flow rate of the medium can be slowed down by setting the infusion channel 234 to bend and extend. If the medium flow rate loaded with the sample is too fast, the reaction will be unstable, and the infusion channel 234 The bending setting can improve the detection stability of the detection tube 2 .
  • the reaction chamber further includes a defoaming chamber 233 , and the defoaming chamber 233 communicates with the collection chamber 231 and the reagent chamber 232 respectively through the infusion channel 234 .
  • the defoaming chamber 233 is located between the collection chamber 231 and the reagent chamber 232.
  • the defoaming chamber 233 is provided between the reagent chamber 232 and the collection chamber 231 to buffer the medium, and the medium passes through the infusion
  • the channel 234 flows into the defoaming chamber 233 and gradually fills the defoaming chamber 233.
  • most of the bubbles remain in the defoaming chamber 233, which can further reduce the number of bubbles entering the reagent chamber 232 and improve For the accuracy and reliability of medium detection.
  • the defoaming chamber 233 is provided with a reagent inlet 2331 communicating with the collection chamber 231, and the size of the reagent inlet 2331 gradually increases toward the direction of the defoaming chamber 233.
  • the reagent passes through the reagent inlet 2331, the liquid flow path As the size increases, the gas in the fluid can be more fully captured in the defoaming chamber 233, thereby reducing the gas entering the reagent chamber 232, so that when detecting the reaction structure in the reagent chamber 232, the detection is more accurate. The influence of air bubbles on the observation of the detection results is eliminated.
  • the reagent chambers 232 and the defoaming chambers 233 are constructed in a one-to-one correspondence and arranged symmetrically with respect to the center of the collection chamber 231 , so as to ensure that the flow rates of reagents entering different reagent chambers 232 are the same.
  • the bottom wall of the bottom wall part 211 is provided with a light entrance position 2111 and a light exit position 2112
  • the detection tube 2 also includes: a first prism 2113 and a second prism 2114, the first prism 2113 and the second prism 2114.
  • a prism 2113 and a second prism 2114 are symmetrically arranged on both sides of the reagent chamber 232 and are respectively facing the light entrance position 2111 and the light exit position 2112.
  • the first prism 2113 is suitable for guiding the light entering from the light entrance position 2111 to the reagent chamber 232
  • the second prism 2114 is adapted to guide the light passing through the reagent chamber 232 to the light exit position 2112 .
  • the detection tube 2 is suitable for optical detection.
  • the instrument for detecting the detection tube 2 is provided with an output unit for emitting light and a receiving unit for receiving light.
  • the light exiting position 2112 is facing directly, the light from the exiting unit enters the reagent chamber 232 under the refraction of the first prism 2113, and is led out by the light exiting position 2112 under the refraction of the second prism 2114, finally received by the receiving unit on the instrument, after the The color analysis of the light finally tells the detection result of the reagent.
  • the bottom wall part 211 is configured as a transparent member, a first light guide groove and a second light guide groove are arranged on both sides of the reagent chamber 232, and the bottom wall of the first light guide groove is inclined to form a It is the first prism 2113, and the bottom wall of the second light guide groove is inclined to be configured as the second prism 2114.
  • the part of the bottom wall part 211 that is opposite to the first light guide groove is configured as the light entrance position 2111, and the bottom wall part 211
  • the part facing the second light guide groove is configured as the light exit position 2112 .
  • the first prism 2113 and the second prism 2114 are respectively arranged at an angle of 30°-60° to the bottom surface of the bottom wall portion 211 , preferably 45°.
  • the outer circumference of the detection tube 2 is provided with a positioning piece 26 protruding in the radial direction, and the positioning piece 26 is used for positioning and restricting the collection assembly 100 when the collection assembly 100 is inserted into the instrument for detection. After the detection tube 2 assembly is inserted and tested together, ensure that the emitting unit and the light-incoming position 2111 of the testing instrument are facing each other, and the receiving unit is facing the light-emitting position 2112.
  • first feature and “second feature” may include one or more of these features.
  • a first feature being "on” or “under” a second feature may include that the first and second features are in direct contact, and may also include that the first and second features are not in direct contact but pass through them. Additional feature contacts between.
  • first feature on the second feature include that the first feature is directly above and obliquely above the second feature, or simply means that the first feature is horizontally higher than Second feature.
  • references to the terms “some embodiments,” “some embodiments,” “illustrative embodiments,” “example,” “specific examples,” or “some examples” are intended to mean that the implementation Specific features, structures, materials, or characteristics described by embodiments or examples are included in at least some embodiments or examples of the present application.
  • schematic representations of the above terms do not necessarily refer to the same embodiment or example.
  • the specific features, structures, materials or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

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Abstract

一种采集总成(100)，采集总成(100)包括：采样管(1)，采样管(1)内设置有样品容纳腔；检测管(2)，检测管(2)内设置有适于容纳采样管(1)的采样腔，采样腔的底壁内形成有试剂反应腔(23)，采样腔的底壁上设置有针头(22)，针头(22)的内部形成有导液通道，针头(22)适于插入样品容纳腔内以使导液通道将采样腔与试剂反应腔(23)连通。

Description

采集总成 技术领域
本申请涉及医疗器械领域，尤其是涉及一种采集总成。
背景技术
相关技术中，对于样品的采集完成后，需用将样品进行转运并进行培养，而样品的转运和培养过程需要保持全程的密封以避免环境污染，采样管以及检测管的密封性尤为重要。对于大批量的采样工作，现有技术中通过滴管的转运方式转运速度慢，效率低，难以可靠地完成大批量的检测化验，对于没有经过操作培训的用户，过程中还伴随一定的风险。对于采样完成后如何对采样管内部的样品进一步转运，以及对样品后续检测过程的优化成为了本领域的技术难题。
发明内容
本申请旨在至少解决现有技术中存在的技术问题之一。为此，本申请的一个目的在于提出采集总成，该采集总成的操作难度低，对于样品的转运更加方便，极大提高了样品转运的效率以及样品转运的安全性。
根据本申请的采集总成包括：采样管，所述采样管内设置有样品容纳腔；检测管，所述检测管内设置有适于容纳所述采样管的采样腔，所述采样腔的底壁内形成有试剂反应腔，所述采样腔的底壁上设置有针头，所述针头的内部形成有导液通道，所述针头适于插入所述样品容纳腔内以使所述导液通道将所述采样腔与所述试剂反应腔连通。
根据本申请的采集总成，通过设置采样管与检测管，采样管用于采集试剂，检测管用于承载采样管，并利用内部的针头将采样管内的试剂导入至试剂反应腔内以完成对于样品的检测，采样管内的介质在转运过程中的流动稳定可靠，密封性好、安全性高，采集总成的操作难度低，转运效率高。
根据本申请的一些实施例，所述采样管上设置有配合部，所述检测管上设置有与所述配合部配合的限位件，所述限位件适于在所述针头插入所述样品容纳腔或所述采样管与所述采样腔的底壁接触时与所述配合部配合以限制所述采样管移动。
根据本申请的一些实施例，所述限位件包括：第一限位件和第二限位件，所述第一限位件与所述第二限位件在所述采样管插入方向上依次间隔布置于所述采样腔的内周；其中所述第一限位件适于在所述针头进入所述采样管内时与所述采样管卡接以限制所述采样管脱离；所述第二限位件适于在所述采样管与所述采样腔的底壁接触时限制所述 采样管脱离。
根据本申请的一些实施例，所述配合部构造为凸出于所述采样管本体外周壁的环形凸筋；所述第一限位件与所述第二限位件均构造为至少部分凸出与所述采样腔内壁的凸起部。
根据本申请的一些实施例，所述采样管上设置有盖体，所述采样管上设置有与样品容纳腔连通的试剂投放口，采样管上设置有盖体，所述盖体可翻转地设置于所述采样管的上端以可选择地封闭所述试剂投放口，所述采样管上形成有第一卡接部，所述盖体上形成有与所述第一卡接部配合的第二卡接部。
根据本申请的一些实施例，所述采样管与所述采样腔的底壁止抵配合时，所述采样腔的外周壁的至少部分与所述第二卡接部正对。
根据本申请的一些实施例，所述第一卡接部构造为形成于所述采样管本体外周壁的卡接缺口，所述第二卡接部构造为形成于所述盖体上的卡接环，所述卡接环的至少部分嵌设于所述卡接缺口内。
根据本申请的一些实施例，所述采样管内形成有适于导向所述针头的导引腔，所述导引腔内设置有第一密封环，所述第一密封环适于与所述针头的外周壁止抵。
根据本申请的一些实施例，所述采样管的外周设置有第二密封环，所述第二密封环设置于所述采样管的外周壁与所述采样腔的内周壁之间。
根据本申请的一些实施例，所述检测管的外周设置有在径向上凸出的定位件。
本申请的附加方面和优点将在下面的描述中部分给出，部分将从下面的描述中变得明显，或通过本申请的实践了解到。
附图说明
本申请的上述和/或附加的方面和优点从结合下面附图对实施例的描述中将变得明显和容易理解，其中：
图1是根据本申请实施例的采样总成的结构示意图；
图2是根据本申请实施例的采样总成的爆炸图；
图3是根据本申请实施例的采样总成的俯视图；
图4是图3中A-A截面的剖视图；
图5是根据本申请实施例的的检测管倒置的结构示意图；
图6是根据本申请实施例的检测管的俯视图；
图7是图2中B-B截面的剖视图；
图8是根据本申请实施例的检测管的侧视图；
图9是根据本申请实施例的检测管的侧向的结构示意图；
图10是根据本申请实施例的检测管的底部结构示意图；
图11是根据本申请实施例的检测管的爆炸图；
图12是根据本申请实施例的采样管本体的结构示意图；
图13是根据本申请实施例的采样管的结构示意图
图14是根据本申请实施例的采样管的俯视图；
图15是图14中C-C截面的剖视图；
图16是根据本申请实施例的支撑壳的结构示意图；
图17是图16中D-D截面的剖视图。
附图标记：
采集总成100，
采样管1
采样管本体11，样品容纳腔111，投放口111a，连通口111b，导引腔112，导向楞113，卡接缺口113a，环形卡接筋114，环形凸筋115，
盖体12，卡接环121，密封筒122，
第一密封环13，第二密封环14，支撑壳15，底壳151，定位筒1511，支撑板152，环形卡槽1521，
第一密封膜101，第二密封膜102。
检测管2
检测管本体21，底壁部211，进光位2111，出光位2112，第一棱镜2113，第二棱镜2114，
周壁部212，
第一配合孔2101，第二配合孔2102，
第一限位件2121，第一凸起部2121a，第二限位件2122，第二凸起部2122a，
针头22，导液通道220，排气槽221，排气口222，倒角223，
试剂反应腔23，
汇集腔231，试剂腔232，消泡腔233，试剂进口2331，输液通道234；
疏水透气膜24，热封膜25，定位件26。
具体实施方式
下面详细描述本申请的实施例，所述实施例的示例在附图中示出，其中自始至终相同或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。下面通过参考附 图描述的实施例是示例性的，仅用于解释本申请，而不能理解为对本申请的限制。
下面参考图1-图17描述根据本申请实施例的采集总成100。
根据本申请的采集总成100包括采样管1和检测管2，采样管1内设置有样品容纳腔111，检测管2内设置有适于容纳采样管1的采样腔，采样腔的底壁内形成有试剂反应腔23，采样腔的底壁上设置有针头22，针头22的内部形成有导液通道220，针头22适于插入样品容纳腔内以使导液通道220将采样腔与试剂反应腔23连通。
根据本申请的采样管1设置有样品容纳腔111，在样品容纳腔111内可以储存有用于检测的载体介质，例如在样品容纳腔111可以用于容纳无酶水。如图13所示，为保证无酶水等载体介质不会被外界环境污染，将样品容纳腔111密封，以保持采样管本体11内的密封环境，在棉签完成采样后，将样品容纳腔111顶部的密封膜揭开，以使带有样品的棉签放入至样品容纳腔111内，使样品溶于介质中。
完成采样后的采样管1容纳于采样腔，在采样管1进入于采样腔过程中，针头22将刺入采样管1内部，并将利用针头22内的导液通道220将采样管1内带有待检测样品的介质导入至检测管本体21底壁内的试剂反应腔23中，样品可以与试剂反应腔23中所存储的试剂发生反应，在反应完成后可以根据试剂的状态判断样品的检测结果。
相关技术中，对于样品的采集完成后，需用将样品进行转运并进行培养，而样品的转运和培养过程需要保持全程的密封以避免环境污染，采样管以及检测管的密封性尤为重要。对于大批量的采样工作，现有技术中通过滴管的转运方式转运速度慢，效率低，难以可靠地完成大批量的检测化验，对于没有经过操作培训的用户，过程中还伴随一定的风险。对于采样完成后如何对采样管内部的样品进一步转运，以及对样品后续检测过程的优化成为了本领域的技术难题。
为此，申请人由进行检测的器具入手进行改进，在于创造一种新型的检测器具以降低转运难度，提高转运效率。
完成采样后的采样管1保持密封状态，并放入至检测管本体21内的采样腔中，以确保转运过程采样管1全程保持密封状态，减少环境污染提高安全性。
进一步地，检测管2通过在采样腔的底壁上设置试剂反应腔23以及在采样腔内壁上设置用于刺穿采样管1的针头22，使得采样管1在容纳于采样腔的过程中，针头22刺入采样管1内部将采样管1内部的带有样品的介质通过导液通道220输送至试剂反应腔23中，以对样品进行反应并完成最终的检测。
根据本申请的检测管2，样品的转运与样品的检测均发生于检测管2中，无需利用其它器具对采样管1内的介质进行操作，减少了样品与空气之间的接触，提高了检测管 2对于样品检测的可靠性，并且检测管2与采样管1之间的配合方式简单可靠，样品的转运效率高。
如图15所示，根据本申请的一些实施例，采样管1包括采样管本体11，采样管本体11内形成有样品容纳腔111和导引腔112，样品容纳腔111的两端敞开以形成投放口111a以及连通口111b，导引腔112设置于连通口111b的下游端且适于导向插入样品容纳腔111的针头22。
根据本申请的采样管1，在采样管1中样品容纳腔111的一端设置有投放口111a，使用者可以通过投放口111a放入进行采样后的棉签，而采样管1中的另一端可以设置有导引腔112以导引针头22刺入连通口111b，从而使含有样品的载体介质通过针头22转运，以进一步进行化验，导引腔112可以方便地刺入针头22，保证针头22刺破采样管1过程的密封性，提高了转运过程的安全性及可靠性。
根据本申请的一些实施例，采样管1上设置有配合部，检测管2上设置有与配合部配合的限位件，限位件适于在针头22插入样品容纳腔或采样管1与采样腔的底壁接触时与配合部配合以限制采样管1移动。
如图5-图10所示，根据本申请的一些实施例，检测管本体21包括底壁部211和周壁部212，底壁部211内设置有试剂反应腔23，周壁部212设置于底壁部211的外周沿并与底壁部211限定出采样腔，周壁部212上设置有限制采样管1脱离的限位件。
底壁部211与周壁部212限定出采样腔以用于容纳采样管1，底壁部211上可以设置有针头22以用于刺穿采样管1，在周壁部212上设置有限位件，限位件可以用于在针头22刺穿采样管1后限制采样管1脱离采样腔，以在针头22刺穿采样管1后，限制采样管1与针头22脱离，确保针头22穿刺采样管1后保持采样管1的内部的密封环境，避免介质与环境中的空气接触，提高了转运过程的可靠性。限位件还可以用于在加采样管1完全插入至采样腔后，限制采样管1的移动，以确保采样管1内介质流动的可靠性。
限位件的设置使检测管2仅能使用一次，在限位件与采样管1上的配合部配合后，除破坏检测管2或采样管1外，无法重复利用，也保证了检测管2与采样管1的医疗安全。
根据本申请的采集总成100，通过设置采样管1与检测管2，采样管1用于采集试剂，检测管2用于承载采样管1，并利用内部的针头22将采样管1内的试剂导入至试剂反应腔23内以完成对于样品的检测，采样管1内的介质在转运过程中的流动稳定可靠，密封性好、安全性高，采集总成100的操作难度低，转运效率高。
根据本申请的一些实施例，限位件包括第一限位件2121和第二限位件2122，第一 限位件2121与第二限位件2122在采样管1的插入方向上依次间隔布置于采样腔的内周。第一限位件2121适于在针头22进入采样管1内时与采样管1卡接以限制采样管1脱离；第二限位件2122适于在采样管1与采样腔的底壁接触时限制采样管1脱离。
采样管1在插入采样腔的过程中，针头22首先会穿刺采样管1，采样管1仍可以继续移动至采样腔的底部。
第一限位件2121和第二限位件2122的位置在采样管1的插入方向依次布置，第一限位件2121适于在针头22进入采样管1内使与采样管1卡接以限制采样管1脱离。在采样管1的继续移动过程中，第二限位件2122适于在采样管1与采样腔的底壁接触时，第二限位件2122与采样管1配合，以限制采样管1脱离采样腔，第二限位件2122适于保持采样管1的稳定性，以确保采样管1在检测过程中采样管1无法脱离采样腔。
如图5和图7所示，根据本申请的一些实施例，周壁部212上设置有第一配合孔2101，第一配合孔2101与检测管本体21延伸方向相同，第二配合孔2102的远离底壁部211的侧边沿上设置有第一限位件2121，第一限位件2121的自由端形成有朝向采样腔凸出的第一凸起部2121a。
如图4所示，采样管1的外周设置有配合部，配合部构造为形成于采样管1下端外周的环形凸筋115，环形凸筋115的上端面为平面以适于与第一限位件2121上所设置的第一凸起部2121a止抵，第一凸起部2121a适于限制环形凸筋115朝向拔出方向移动。
根据本申请的一些实施例，周壁部212上设置有第二配合孔2102，第二配合孔2102与检测管本体21延伸方向相同，第二配合孔2102的远离底壁部211的侧边沿上设置有第二限位件2122，第二限位件2122的自由端形成有朝向采样腔凸出的第二凸起部2122a。环形凸筋115的上端面为平面以适于与第二限位件2122上所设置的第二凸起部2122a止抵，第二凸起部2122a适于限制环形凸筋115朝向拔出方向移动。
这里需要说明是，第一凸起部2121a与第二凸起部2122a的位置在采样管1的插入方向上依次布置，第一凸起部2121a适于在针头22穿刺采样管1后与配合部卡接，第二凸起部2122a适于在采样管1完全插入至采样腔后与配合部卡接。
如图12所示，根据本申请的一些实施例，采样管1还设置有有与样品容纳腔连通的试剂投放口，采样管上设置有盖体12，盖体12可翻转地设置于采样管本体11的上端以可选择地封闭投放口111a，采样管本体11上形成有第一卡接部，盖体12上形成有与第一卡接部配合的第二卡接部，在撕掉密封膜后投放口111a处于敞开状态，利用盖体12以将投放口111a封闭，使样品容纳腔111成为密封空间，此时通过摇晃采样管1使载体介质与完成采样的棉签充分进行接触。盖体12可以在采样完成后，保持样品 容纳腔111内的密封性，避免样品在转运过程中发生污染。
进一步地，采样管本体11上设置有第一卡接部，盖体12上设置有第二卡接部，利用第一卡接部与第二卡接部配合，防止盖体12意外打开，第一卡接部与第二卡接部配合后，可以使盖体12与投放口111a的边缘之间产生一定的压力，保证了盖体12封闭投放口111a后样品容纳腔111的密封性。
根据本申请的一些实施例，盖体12上设置沿轴向凸出的密封筒122，在盖体12封闭投放口111a时密封筒122的至少部分伸入至样品容纳腔111内，密封筒122的外周壁与样品容纳腔111的内周壁之间止抵配合，以确保盖体12对于样品容纳腔111的密封效果。
进一步地，密封筒122的外周设置有凸出部，以使密封筒122可以与投放口111a之间过盈配合。
在另一些实施例中，投放口111a的内周壁上设置有密封件，密封件构造为橡胶件，密封件设置于密封筒122的外周壁与投放口111a的内周壁之间，以利用密封件进一步提高密封效果。
在一些实施例中，在密封筒122的外周设置有密封件，密封件构造为橡胶件，以利用密封件进一步提高密封盖的密封性能。
如图13所示，根据本申请的一些实施例，第一卡接部构造为形成于采样管1外周壁的卡接缺口113a，第二卡接部构造为形成于盖体12上的卡接环121，卡接环121的至少部分嵌设于卡接缺口113a内。利用卡接环121与卡接缺口113a的配合，以实现盖体12在封闭投放口111a状态下的稳定性，提高了采样管1的密封性能。
根据本申请的一些实施例，采样管本体11的外周设置有多个间隔布置的导向楞113，导向楞113在采样管本体11的径向上凸出并在轴向上延伸，对称的任意两个导向楞113的上端设置有卡接缺口113a，对应地卡接环121构造为两个且对称设置于盖体12的外周。
在采样管本体11的外周设置导向楞113，可以在采样管1收容于检测管2时，对采样管1的周向进行定位，从而避免采样管1转动，也可以利用导向楞113提高采样管1的结构强度，以更好地保护采样管1内部的载体介质。
在导向楞113的上端设置卡接缺口113a，而对应在盖体12上设置有卡接环121，在盖体12翻转过程中，卡接环121翻转至采样管本体11侧部，卡接环121的至少部分于卡接缺口113a正对，在盖体12上的密封筒122伸入至投放口111a内时，卡接环121的至少部分也同时嵌入至卡接缺口113a内以实现对盖体12的固定。
如图13所示，卡接环121构造为两个且对称设置，其中两个卡接环121的对称中心线为穿过盖体12相对采样管本体11的铰接点，盖体12与采样管本体11通过铰接点相连，盖体12通过两个卡接环121以及铰接点实现了与采样管本体11的连接，而上述的三个位置可以保证盖体12上所分布的压力均匀，以提高盖体12对于投放口111a的密封效果。
根据本申请的一些实施例，采样管1与采样腔的底壁止抵配合时，采样腔的外周壁的至少部分与第二卡接部正对，从而使得采样管1在完全插入至采样腔的底壁后，采样腔的外周壁用于限制第二卡接部的移动，从而避免盖体12的意外开启，确保采样管1与检测管2配合后的可靠性。
根据本申请的一些实施例，采样管1还包括第一密封环13，第一密封环13设置于导引腔112内且适于与针头22的外周壁止抵，在针头22刺入第一密封膜101的过程中，导引腔112内存有环境气体，为确保针头22刺入过程中不会被环境中的气体所污染，需要保证针头22刺入时的为密封且隔绝外部环境气体的封闭空间。第一密封环13可以邻近第一密封膜101设置，优选为与第一密封膜101止抵，在针头22进入导引腔112的过程中，针头22需用穿过第一密封环13，第一密封环13与针头22的外周壁止抵，以在第一密封环13与第一密封膜101之间形成一个相对密封的腔室，从而在针头22刺穿第一密封膜101的过程中，大大减少外界环境污染针头22以及样品容纳腔111内样品的可能，进一步提高了样品检测的可靠性。
如图15所示，根据本申请的一些实施例，采样管1还包括第二密封环14，第二密封环14设置于采样管本体11的外周，采样管1需要插入至检测管2内进行样品检测，在检测管2内设置有采样腔，为进一步减少环境的污染，在采样管1进入采样腔的过程需要进一步密封，以确保针头22刺破第一密封膜101时不会有空气污染载体介质。
在采样管本体11的外周设置第二密封环14，可以在采样管1进入采样腔的过程中与采样腔的内壁止抵，从而在采样腔的底部形成相对密封的腔室，大大减少外界环境污染针头22以及样品容纳腔111内样品的可能，进一步提高了样品检测的可靠性。
如图16-图17所示，根据本申请的一些实施例，采样管1还包括支撑壳15，支撑壳15包括底壳151，底壳151上设置有与导引腔112正对的连通过孔，连通过孔适于针头22通过以在经过导引腔112后刺入第一密封膜101，底壳151的外周还设置有支撑板152，支撑板152朝向远离底壳151的方向延伸且自由端与第二密封环14止抵，其中底壳151或支撑板152与采样管本体11固定连接。
支撑壳15用于支撑第二密封环14，在底壳151与支撑板152相对采样管本体11 固定后，支撑板152可以用于限制第二密封环14在一个方向上的移动，由于第二密封环14在与采样腔的内周壁发生接触时，第二密封环14需要承受摩擦力，为避免第二密封环14移动扭曲发生密封失效，通过支撑壳15与第二密封环14止抵以限制第二密封环14移动，确保采样管1进入采样腔的过程中第二密封环14的密封稳定。
进一步地，在采样管本体11的外周壁上还形成有用于限制第二密封环14在另一个方向上移动的台阶部，台阶部止抵于第二密封环14的上侧，支撑板152支撑于第二密封环14的下侧。
如图15所示，根据本申请的一些实施例，支撑板152与采样管本体11外周壁中的一个上设置有第三卡接部，支撑板152与采样管本体11外周壁中的另一个上设置有第四卡接部，具体地，支撑板152的内周壁上设置环形卡槽1521，采样管本体11的外周设置有与环形卡槽1521配合的环形卡接筋114。
如图17所示，根据本申请的一些实施例，底壳151上设置有朝向导引腔112内部延伸的定位筒1511，定位筒1511的自由端与所述第一密封环13正对，以限制第一密封环13的移动，此外，定位筒1511的外周壁可以与导引腔112的内周壁配合以对底壳151进行定位，确保底壳151的位置不会相对采样管本体11偏心，定位筒1511内形成连通过孔。
如图8及图10所示，根据本申请的一些实施例，针头22的端面的至少部分内凹以形成排气槽221，排气槽221的至少一端于针头22的周向侧壁上敞开以形成排气口222。
针头22在穿刺采样管1的密封膜瞬间，密封膜的上方有液体压力，密封膜的下方有大气压力。对于更传统针尖设计，密封膜的表面会在穿刺的瞬间形成大气与液体压力的接触面，导致气体摄入与液体摄入同时发生，因此大量的气体通过针头22进入到试剂反应腔23内，导致试剂反应腔23内出现大气泡，影响对于试剂检测结果的分析准确度。
根据本申请的针头22可以减少针头22刺穿流体系统时吸入流体系统的气体量，在密封膜的穿刺点处，尽量减少针头22穿刺密封膜后所形成的形孔之间的间隙。利用在针头22端面上所形成的排气槽221，以及将针头22的端部设计为内凹形，可以在针头22穿刺的过程中将空气排出，从而极大减少了空气通过导液通道220进入至试剂反应腔23内。
根据本申请的一些实施例，针头22的端面构造为弧形面、折线面或双曲抛物面。
在本申请的一个具体实施例中，针头22的端面构造为双曲抛物面，双曲抛物面凹入的两端形成排气口222，针头22端面的外周沿形成有的彼此正对的凸棱边缘，凸棱 边缘用于穿刺采样管1上的密封膜。
根据本申请的一些实施例，排气口222出形成有倒角223，排气口222处所形成的倒角223可以进一步提高排气口222的尺寸，提高了在针头22穿刺密封膜时的排气效果，以进一步降低气体进入到试剂反应腔23的可能性。
如图5和图6所示，根据本申请的一些实施例，试剂反应腔23包括，汇集腔231和试剂腔232，汇集腔231与导液通道220的另一端连通，试剂腔232适于容纳试剂且与汇集腔231连通。汇集腔231用于汇集来自导液通道220的介质，介质汇集完成后导入至试剂腔232中并与试剂腔232内的试剂反应。
在本申请的一些实施例中，底壁部211的低端形成汇集槽，汇集槽设置于底壁部211的中心且与针头22的导液通道220正对，底壁部211的低端还形成有试剂槽，试剂槽与汇集槽之间通过流道槽连通。底壁部211的低端设置有热封膜25，通过设置热封膜25以将汇集槽以及试剂槽密封以形成试剂腔232以及汇集腔231。
在本申请的一些实施例中，试剂槽构造为在厚度方向贯通底壁部211的通槽，在底壁部211的顶面设置有疏水透气膜24，热封膜25与疏水透气膜24公共用于密封试剂槽以形成试剂腔232。
根据本申请的一些实施例，试剂腔232构造为多个，每个试剂腔232与汇集腔231之间设置有输液通道234，输液通道234在汇集腔231与试剂腔232之间弯曲延伸。将试剂腔232构造为多个以用于容纳多组试剂，位于每个试剂腔232内的试剂可以相同也可以不同，相同的试剂可以用于对照试验，不同的试剂可以用于对同一样品进行不同类型的测试。
在试剂腔232与汇集腔231之间设置输液通道234，并且通过设置输液通道234弯曲延伸可以减缓介质的流速，载有样品的介质流速过快会导致反应的不稳定，而通过将输液通道234弯曲设置，可以提高检测管2检测的稳定性。
根据本申请的一些实施例，反应腔还包括消泡腔233，消泡腔233分别通过输液通道234与汇集腔231与试剂腔232连通。消泡腔233位于汇集腔231与试剂腔232之间，为减小介质内的气泡，通过在试剂腔232与汇集腔231之间设置消泡腔233以用于对介质进行缓冲，介质通过输液通道234流动至消泡腔233内逐渐将消泡腔233填充，在介质的继续流动过程中，气泡大部分留存于消泡腔233内，可以进一步减小进入试剂腔232内的气泡数量，提高对于介质检测的精度及可靠性。
根据本申请的一些实施例，消泡腔233设置有与汇集腔231连通的试剂进口2331，试剂进口2331朝向消泡腔233的方向上尺寸逐渐增大，试剂在经过试剂进口2331时液 体流道的尺寸增加，流体中的气体可以更充分地被捕捉在消泡腔233中，从而减小了进入试剂腔232内的气体，以使在检测试剂腔232内的反应结构时，检测更加准确，消除了气泡对于检测结果的观测影响。
根据本申请的一些实施例，试剂腔232、与消泡腔233构造为一一对应的多个且关于汇集腔231中心对称设置，从而确保试剂进入不同的试剂腔232内的流速流量相同。
如图5所示，根据本申请的一些实施例，底壁部211的底壁上设置有进光位2111和出光位2112，检测管2还包括：第一棱镜2113和第二棱镜2114，第一棱镜2113与第二棱镜2114对称设置于试剂腔232的两侧且分别与进光位2111和出光位2112正对，第一棱镜2113适于将由进光位2111射入的光线导向试剂腔232，第二棱镜2114适于将经过试剂腔232的光线导向出光位2112。
根据本申请的检测管2适用于光学检测，用于检测检测管2的仪器设置有用于发出光线的出射单元以及用于接收光线的接收单元，出射单元与进光位2111正对，接收单元与出光位2112正对，出射单元的光线在第一棱镜2113的折射下进入试剂腔232，并在第二棱镜2114的折射下由出光位2112导出，最终由仪器上的接收单元所接收，经过对光线的颜色分析最终得知试剂的检测结果。
根据本申请的一些实施例，底壁部211构造为透明件，位于试剂腔232的两侧设置有第一导光槽以及第二导光槽，第一导光槽的底壁倾斜设置以构造为第一棱镜2113，第二导光槽的底壁倾斜设置以构造为第二棱镜2114，底壁部211中与第一导光槽正对的部分构造为进光位2111，底壁部211中与第二导光槽正对的部分构造为出光位2112。第一棱镜2113与第二棱镜2114分别与底壁部211的底面呈30°-60°角设置，优选为45°。
根据本申请的一些实施例，检测管2的外周设置有在径向上突出的定位件26，定位件26用于在采集总成100插入至仪器检测过程中，用于定位以及限制采集总成100的转动，提高检测管2总成在插入检测一起后，确保检测仪器中出射单元与进光位2111正对，接收单元与出光位2112正对。
在本申请的描述中，需要理解的是，术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。
在本申请的描述中，“第一特征”、“第二特征”可以包括一个或者更多个该特征。
在本申请的描述中，“多个”的含义是两个或两个以上。
在本申请的描述中，第一特征在第二特征“之上”或“之下”可以包括第一和第二特征直接接触，也可以包括第一和第二特征不是直接接触而是通过它们之间的另外的特征接触。
在本申请的描述中，第一特征在第二特征“之上”、“上方”和“上面”包括第一特征在第二特征正上方和斜上方，或仅仅表示第一特征水平高度高于第二特征。
在本说明书的描述中，参考术语“一些实施例”、“一些实施例”、“示意性实施例”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本申请的至少一些实施例或示例中。在本说明书中，对上述术语的示意性表述不一定指的是相同的实施例或示例。而且，描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。
尽管已经示出和描述了本申请的实施例，本领域的普通技术人员可以理解：在不脱离本申请的原理和宗旨的情况下可以对这些实施例进行多种变化、修改、替换和变型，本申请的范围由权利要求及其等同物限定。

Claims (10)

  1. 一种采集总成，其特征在于，包括：
    采样管，所述采样管内设置有样品容纳腔；
    检测管，所述检测管内设置有适于容纳所述采样管的采样腔，所述采样腔的底壁内形成有试剂反应腔，所述采样腔的底壁上设置有针头，所述针头的内部形成有导液通道，所述针头适于插入所述样品容纳腔内以使所述导液通道将所述采样腔与所述试剂反应腔连通。
  2. 根据权利要求1所述的采集总成，其特征在于，所述采样管上设置有配合部，所述检测管上设置有与所述配合部配合的限位件，所述限位件适于在所述针头插入所述样品容纳腔或所述采样管与所述采样腔的底壁接触时与所述配合部配合以限制所述采样管移动。
  3. 根据权利要求2所述的采集总成，其特征在于，所述限位件包括：第一限位件和第二限位件，所述第一限位件与所述第二限位件在所述采样管插入方向上依次间隔布置于所述采样腔的内周；其中
    所述第一限位件适于在所述针头进入所述采样管内时与所述采样管卡接以限制所述采样管脱离；
    所述第二限位件适于在所述采样管与所述采样腔的底壁接触时限制所述采样管脱离。
  4. 根据权利要求3所述的采集总成，其特征在于，所述配合部构造为凸出于所述采样管外周壁的环形凸筋；所述第一限位件与所述第二限位件均构造为至少部分凸出与所述采样腔内壁的凸起部。
  5. 根据权利要求1-4中任意一项所述的采集总成，其特征在于，所述采样管上设置有与样品容纳腔连通的试剂投放口，采样管上设置有盖体，所述盖体可翻转地设置于所述采样管的上端以可选择地封闭所述试剂投放口，所述采样管上形成有第一卡接部，所述盖体上形成有与所述第一卡接部配合的第二卡接部。
  6. 根据权利要求5所述的采集总成，其特征在于，所述采样管与所述采样腔的底壁止抵配合时，所述采样腔的外周壁的至少部分与所述第二卡接部正对。
  7. 根据权利要求5或6所述的采集总成，其特征在于，所述第一卡接部构造为形成于所述采样管本体外周壁的卡接缺口，所述第二卡接部构造为形成于所述盖体上的卡接环，所述卡接环的至少部分嵌设于所述卡接缺口内。
  8. 根据权利要求1-7中任意一项所述的采集总成，其特征在于，所述采样管内形成有适于导向所述针头的导引腔，所述导引腔内设置有第一密封环，所述第一密封环适于与所述针头的外周壁止抵。
  9. 根据权利要求1-7中任意一项所述的采集总成，其特征在于，所述采样管的外周设置有第二密封环，所述第二密封环设置于所述采样管的外周壁与所述采样腔的内周壁之间。
  10. 根据权利要求1-9中任意一项所述的采集总成，其特征在于，所述检测管的外周设置有在径向上凸出的定位件。
PCT/CN2021/116784 2021-09-06 2021-09-06 采集总成 WO2023029054A1 (zh)

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