A sample collection device and method

Abstract

The application discloses a sample collection device and method, the sample collection device comprises a hollow shell and a trigger, a fixed rod, a driving elastic element and microneedles accommodated in the shell, the shell comprises a sampling port arranged at one end thereof and a storage pool in communication with the sampling port, the shell is provided with an operation hole corresponding to the trigger, the trigger has a pressing portion extending to the outside of the shell through the operation hole and a driving portion accommodated in the shell, and the shell is provided with a guide member opposite to and spaced from the driving portion. In use, the sample collection device is abutted against the skin, the pressing portion of the trigger is pressed, the trigger extrudes the driving elastic element, the driving portion cooperates with the guide member to guide the fixed rod to drive the microneedles to stretch out of the shell through the sampling port to pierce the skin and collect the sample, and the sample flows into the storage pool through the pierced skin to realize the collection of the sample. That is, the application only needs to press the trigger to realize the collection of the sample, and the operation of professionals is not needed, so that the user can collect the sample at home.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a sample collection device and method. BACKGROUND

[0002] Sampling is the first step of detecting health indicators of human body. A safe and effective sampling method can not only ensure that the person being tested is not infected or harmed during the sampling process, but also improve the accuracy of the detection after sampling and early detection of diseases in the body. Sampling of human body fluids, especially blood, is the most commonly used method in human body detection.

[0003] There are mainly two ways to sample human blood at present: venous blood and fingertip blood. The size and length of the venous blood sampling needle are 2.5-4 cm, and the diameter of the needle body is 0.5-1.5 mm; the needle needs to be inserted into the venous blood vessel during blood sampling. The size of the fingertip blood needle used for collecting fingertip blood is 1.5-2.5 mm, and the penetration depth is 2-3 mm. These methods will inevitably cause pain during blood sampling. During the process of collecting fingertip blood, the wound needs to be squeezed hard, which not only brings physical discomfort to the patient, but also easily causes red blood cell rupture, hemolysis and affects the accuracy of subsequent detection. With the rapid development of POCT (point-of-care testing), more and more projects need to be completed by patients at home, and the current blood sampling methods all need to be completed by professionals in hospitals and inevitably cause pain, so that people, especially children, are often very resistant to such blood sampling methods. SUMMARY

[0004] Therefore, the first object of the present application is to provide a sample collection device, which is designed to facilitate users to collect samples at home.

[0005] The second object of the present application is to provide a sample collection method.

[0006] In order to achieve the above-mentioned first object, the present application provides the following scheme:

[0007] A sample collection device, comprising:

[0008] a hollow shell, the shell comprising a sampling port arranged at one end thereof and a storage pool in communication with the sampling port;

[0009] and a trigger, a fixed rod, a driving elastic element and a microneedle accommodated in the shell.

[0010] The shell is provided with an operation hole corresponding to the trigger, the trigger has a pressing portion extending out of the shell through the operation hole and a driving portion accommodated in the shell, the shell has a guide member arranged opposite to and spaced from the driving portion, the fixing rod is accommodated between the driving portion and the guide member, and the fixing rod is fixed with the microneedle at an end away from the trigger, so that the microneedle can extend out of the shell from the sampling port;

[0011] The driving elastic element is sleeved outside the fixing rod, the driving elastic element is extruded by the trigger after being pressed, and the driving portion and the guide member cooperate to guide the fixing rod to drive the microneedle to extend out of the shell from the sampling port to pierce the skin for sample collection.

[0012] The storage pool is communicated with the sampling port and used for storing the sample collected through the sampling port.

[0013] In one specific embodiment, the fixing rod comprises a main body portion extending along the moving direction of the microneedle and at least one positioning rod extending outward from the outer side of the main body portion, the driving elastic element is sleeved outside the main body portion and arranged between the positioning rod and the trigger, and the sample collection device further comprises a reset elastic element sleeved at an end of the main body portion away from the trigger and located between the positioning rod and the shell, the reset elastic element is used for moving the fixing rod towards the trigger to drive the microneedle away from the skin.

[0014] In another specific embodiment, the shell comprises an upper cover and a base;

[0015] The upper cover is buckled on the base;

[0016] The sampling port is arranged on the base, the operation hole is arranged on the upper cover, the size of the pressing portion is smaller than the aperture of the operation hole, the size of the driving portion is larger than the aperture of the operation hole, and the pressing portion at least partially extends out of the upper cover.

[0017] In another specific embodiment, the guide member comprises a support table surrounding the sampling port and extending from the base towards the trigger, and at least one stand column protruding from the side wall of the support table;

[0018] The driving portion comprises an annular accommodation portion arranged opposite to and spaced from the support table, and at least one pushing portion extending from an end of the annular accommodation portion away from the pressing portion towards the support table;

[0019] The two ends of the main body part are respectively accommodated in the support table and the annular accommodating part, and at least one positioning rod is located between the support table and the annular accommodating part and extends to outside of the support table and the annular accommodating part along the projection of the moving direction of the microneedle;

[0020] A single pushing part is located between the single positioning rod and the single column, a first inclined surface is arranged on the side of the pushing part close to the column, a second inclined surface is arranged on the side of the pushing part close to the positioning rod, and the first inclined surface and the second inclined surface extend from the annular accommodating part to the direction of approaching each other to form the pushing part.

[0021] In another specific embodiment, an end of the support table away from the base is partially recessed to form a recessed part, the recessed part is located on the side of the column close to the pushing part and is arranged in a spaced manner with the column, and the pushing part cooperates with the column to guide the positioning rod to move from the end surface of the annular accommodating part to the recessed part.

[0022] In another specific embodiment, at least two positioning rods are arranged in a uniformly spaced manner along the circumference of the main body part.

[0023] The positioning rods are arranged in a one-to-one correspondence with the pushing parts, the recessed parts, and the columns, respectively.

[0024] In another specific embodiment, the driving part further comprises a limiting part extending from an end of the annular accommodating part away from the pressing part towards the support table.

[0025] The limiting part is arranged in a spaced manner with the pushing part and is used for limiting excessive rotation of the positioning rod caused by extrusion of the pushing part.

[0026] In another specific embodiment, the reset elastic element is sleeved on one end of the main body part and is accommodated in the support table and abuts between the base and the positioning rod.

[0027] In another specific embodiment, a surrounding wall is protrudingly arranged on the side of the base close to the trigger, and the surrounding wall and the base jointly surround the storage pool.

[0028] An end of the base away from the trigger is recessed to form a groove around the sampling port, the groove is in communication with the sampling port, and a communication hole in communication with the storage pool is arranged on the side wall of the storage pool close to the groove.

[0029] In another specific embodiment, at least a part of the side wall of the storage pool is a first puncturable side wall.

[0030] The upper cover is provided with a second puncturable side wall corresponding to the position of the first puncturable side wall, so as to extract the sample in the storage pool through the second puncturable side wall and the first puncturable side wall.

[0031] In another specific embodiment, the microneedle comprises a sheet-shaped base fixed to the fixed rod and a needle body extending from the base away from the fixed rod.

[0032] In another specific embodiment, the plurality of needle bodies are uniformly spaced on the base and coplanar with the base.

[0033] In another specific embodiment, the needle body has a length of 800-1300 microns, a width of 150-500 microns, and a thickness of 20-50 microns.

[0034] In another specific embodiment, the microneedle is a sheet structure, and the base is provided with a positioning hole.

[0035] According to various embodiments of the present application, any combination thereof can be arbitrarily combined as needed, and the resulting embodiments after the combination are also within the scope of the present application and are part of the specific embodiments of the present application.

[0036] The sample collection device provided by the present application is used to abut the end of the sample collection device away from the trigger against the skin, press the pressing part of the trigger, and the trigger extrudes the driving elastic element. The driving part cooperates with the guide to guide the fixed rod to drive the microneedle to extend out of the shell through the sampling port to pierce the skin for sample collection. The sample flows into the storage pool through the pierced skin to realize sample collection. That is, the present application only needs to press the trigger to realize sample collection, without the need for professional operation, so that users can also collect samples at home.

[0037] In order to achieve the second object, the present application provides the following scheme:

[0038] A sample collection method comprises:

[0039] Providing a sample collection device as described in any one of the above embodiments;

[0040] Pressing the trigger, the trigger extrudes the driving elastic element, the driving part cooperates with the guide to guide the fixed rod to move towards the skin, so that the fixed rod drives the microneedle to pierce the skin, and the sample flows into the storage pool through the pierced skin. BRIEF DESCRIPTION OF DRAWINGS

[0041] In order to make the technical solutions of the embodiments of the present application or the prior art clearer, the accompanying drawings needed in the embodiments or prior art description will be briefly introduced. Obviously, the accompanying drawings in the following description only need to be some embodiments of the present application, and other drawings can be obtained by those skilled in the art without any inventive labor.

[0042] Figure 1 The schematic diagram of the explosion structure of the sample collection device provided by the present application is shown in the figure.

[0043] Figure 2 The schematic diagram of the three-dimensional structure of the sample collection device provided by the present application is shown in the figure.

[0044] Figure 3 The schematic diagram of the cross-sectional structure of the sample collection device provided by the present application is shown in the figure.

[0045] Figure 4a The schematic diagram of the three-dimensional structure of the base provided by the present application is shown in the figure.

[0046] Figure 4b The schematic diagram of the three-dimensional structure of the base provided by the present application is shown in the figure.

[0047] Figure 4c The schematic diagram of the top structure of the base provided by the present application is shown in the figure. Figure 4a

[0048] Figure 5 The schematic diagram of the structure of the trigger provided by the present application is shown in the figure.

[0049] Figure 6 The schematic diagram of the structure of the fixed rod provided by the present application is shown in the figure.

[0050] Figure 7 The schematic diagram of the structure of the upper cover provided by the present application is shown in the figure.

[0051] Figure 8 The schematic diagram of the structure of the sample collection device provided by the present application without installing the upper cover is shown in the figure.

[0052] Figure 9 The schematic diagram of the structure of the microneedle provided by the present application is shown in the figure.

[0053] Figure 10 The schematic diagram of the structure of the microneedle provided by the present application is shown in the figure.

[0054] Figure 11 The schematic diagram of the structure of the puncture needle provided by the present application is shown in the figure.

[0055] Figure 12a The schematic diagram of the front view structure of the needle tip provided by the first embodiment of the present application is shown in the figure.

[0056] Figure 12b ​The front view structure schematic diagram of the needle tip provided for the second embodiment of the present application;

[0057] Figure 12c The front view structure schematic diagram of the needle tip provided for the third embodiment of the present application;

[0058] Figure 13a The cross section structure schematic diagram of the needle body provided for the first embodiment of the present application;

[0059] Figure 13b The cross section structure schematic diagram of the needle body provided for the second embodiment of the present application;

[0060] Figure 13c The cross section structure schematic diagram of the needle body provided for the third embodiment of the present application;

[0061] Figure 14a The schematic diagram of the base surrounding mode provided for the first embodiment of the present application;

[0062] Figure 14b The schematic diagram of the base surrounding mode provided for the second embodiment of the present application;

[0063] Figure 14c The schematic diagram of the base surrounding mode provided for the third embodiment of the present application;

[0064] Figure 14d The schematic diagram of the base surrounding mode provided for the fourth embodiment of the present application;

[0065] Figure 14e The schematic diagram of the base surrounding mode provided for the fifth embodiment of the present application;

[0066] Figure 14f The schematic diagram of the base surrounding mode provided for the sixth embodiment of the present application;

[0067] Figure 14g The schematic diagram of the base surrounding mode provided for the seventh embodiment of the present application;

[0068] Figure 14h The schematic diagram of the base surrounding mode provided for the eighth embodiment of the present application;

[0069] Figure 14i The schematic diagram of the base surrounding mode provided for the ninth embodiment of the present application.

[0070] Wherein, Figures 1-14i In the middle:

[0071] Microneedle 10, base 11, positioning hole 11a, needle body 12, needle main body 12a, needle tip 12b, sample collection device 100, shell 20, top cover 21, operation hole 21a, second puncturable sidewall 21b, base 22, sampling port 22a, guide 22b, column 22b-1, support platform 22b-2, recess 22c, trigger 30, pressing part 31, driving part 32, annular receiving part 32a, pushing part 32b, second inclined surface 32b-2, first inclined surface 32b-1, limiting part 33, fixing rod 40, positioning rod 41, main body part 42, reset elastic element 50, storage pool 60, first puncturable sidewall 61, first storage pool 62, second storage pool 63, groove 22d, connecting hole 22d-1, driving elastic element 70. Detailed Implementation

[0072] The following will refer to the appendices in the embodiments of the present invention. Figures 1-14i The technical solutions in the embodiments of the present invention are clearly and completely described herein. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0073] In the description of this invention, it should be understood that the terms "upper," "lower," "top surface," "bottom surface," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the indicated position or element must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations of the invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0074] Combination Figures 1-14i As shown, one aspect of the present invention provides a sample collection device 100, which includes a microneedle 10, a housing 20, a trigger 30, a fixing rod 40, and a driving elastic element 70, such as... Figures 1-3 As shown.

[0075] The housing 20 is a hollow housing, meaning it has an internal cavity. The trigger 30, the fixing rod 40, the microneedle 10, and the driving elastic element 70 are all housed within the housing 20. Figure 3 As shown.

[0076] The housing 20 includes a sampling port 22a and a storage pool 60, such as Figures 4a-4c As shown, specifically, sampling port 22a is located at one end of housing 20, and storage pool 60 is connected to sampling port 22a for storing samples collected through sampling port 22a.

[0077] The housing 20 is provided with an operation hole 21a corresponding to the trigger 30, and the trigger 30 has a pressing portion 31 and a driving portion 32, as shown in the figure, wherein the pressing portion 31 extends out of the housing 20 through the operation hole 21a, and the driving portion 32 is accommodated in the housing 20. Figure 5

[0078] The housing 20 is provided with a guide 22b which is arranged opposite and spaced apart from the driving portion 32.

[0079] The fixed rod 40 is accommodated between the driving portion 32 and the guide 22b, and one end of the fixed rod 40 away from the trigger 30 is fixed with the microneedle 10, which can extend out of the housing 20 through the sampling port 22a. Specifically, the annular structure surrounded by the base 11 of the microneedle 10 is sleeved on the outer wall of the bottom end of the fixed rod 40, and is fastened with the fixed rod 40 through the connecting hole 11a on the base 11.

[0080] The driving elastic element 70 is sleeved outside the fixed rod 40, and the trigger 30 is pressed to extrude the driving elastic element 70, and the driving portion 32 cooperates with the guide 22b to guide the fixed rod 40 to drive the microneedle 10 to extend out of the housing 20 through the sampling port 22a, so as to pierce the skin to collect the sample.

[0081] In the initial state, the microneedle 10 is accommodated in the housing 20, and when sampling, the microneedle 10 pierces into the skin through the sampling port 22a.

[0082] The sample collection device 100 provided by the application is used to abut the end of the sample collection device 100 away from the trigger against the skin, press the pressing portion 31 of the trigger 30, extrude the driving elastic element 70 with the trigger 30, and drive the fixed rod 40 to drive the microneedle 10 to extend out of the housing 20 through the sampling port 22a to pierce the skin to collect the sample, and the sample flows into the storage pool 60 through the pierced skin to realize the collection of the sample. That is, the application only needs to press the trigger 30 to realize the collection of the sample, without the need for professional operation, so that the user can collect by himself at home.

[0083] In some embodiments, the fixed rod 40 includes a main body 42 extending along the moving direction of the microneedle 10 and at least one positioning rod 41 extending outward from the outer side of the main body 42, as shown in the figure. Figure 6 ​The positioning rod 41 is vertically connected with the main body 42, and of course, the positioning rod 41 can be arranged to be inclined at a certain angle. The reset elastic element is sleeved outside the main body 42, and one end is abutted with the positioning rod 41. It should be noted that the number of the positioning rod 41 is not limited to one, and two or more than two can be arranged, and are evenly distributed along the axis of the main body 42 on the main body 42, so as to uniformly apply force to the reset elastic element 50. It can be understood that the positioning rod 41 can also be arranged on the main body 42 at unequal intervals around the axis of the main body 42.

[0084] The driving elastic element 70 is sleeved on the main body 42 and arranged between the positioning rod 41 and the trigger 30. Specifically, the driving elastic element 70 is a spring. It should be noted that the driving elastic element 70 is not limited to a spring, but can also be other elastic members.

[0085] The sample collection device 100 further comprises a reset elastic element 50, which is sleeved on one end of the main body 42 away from the trigger 30 and located between the positioning rod 41 and the shell 20, for moving the fixing rod 40 towards the trigger 30 to drive the microneedle 10 away from the skin, and realizing the reset of the trigger 30. Figure 3 As shown in the figure, one end of the reset elastic element 50 is abutted or connected with the positioning rod 41, and the other end of the reset elastic element 50 is abutted or connected with the bottom end of the inner wall of the shell 20. Specifically, the reset elastic element 50 is a spring. It should be noted that the reset elastic element 50 is not limited to a spring, but can also be other elastic members.

[0086] In some embodiments, the shell 20 comprises an upper cover 21 and a base 22, and the upper cover 21 is buckled on the base 22, facilitating disassembly and assembly of the shell 20.

[0087] The sampling port 22a is opened on the base 22, as shown in the figure. Figure 4a The operation hole 21a is opened on the upper cover 21, as shown in the figure. Figure 7

[0088] The size of the pressing part 31 is smaller than the hole diameter of the operation hole 21a, and the size of the driving part 32 is larger than the hole diameter of the operation hole 21a, so that the driving part 32 can be accommodated in the shell 20 and abutted with the upper cover 21 under the action of the driving elastic element 70.

[0089] The pressing part 31 can slide in the operation hole 21a, and at least a part of the pressing part 31 extends out of the upper cover 21.

[0090] Further, the sampling port 22a and the operation hole 21a are both circular holes, and are coaxially arranged.

[0091] ​The pressing part 31 is adapted to the shape of the operation hole 21a, so that the pressing part 31 can slide along the operation hole 21a. When the operation hole 21a is a circular hole, the pressing part 31 corresponds to a cylindrical or cylindrical shape. In order to avoid finger slipping when pressing, the top end surface of the pressing part 31 is provided with a non-slip pattern layer or a non-slip pad is pasted and the like.

[0092] In order to facilitate processing, the driving part 32 is also cylindrical or cylindrical, and is coaxially arranged with the pressing part 31. The outer diameter of the driving part 32 is greater than the outer diameter of the pressing part 31 and the inner diameter of the operation hole 21a.

[0093] In some embodiments, the guide 22b includes a support table 22b-2 and a column 22b-1. The support table 22b-2 is formed around the sampling port 22a and extends from the base 22 to the trigger 30. The column 22b-1 is protruding from the side wall of the support table 22b-2, and the number of columns 22b-1 is at least one.

[0094] The driving part 32 includes an annular receiving part 32a and a pushing part 32b. The annular receiving part 32a is oppositely and spacedly arranged with the support table 22b-2. The pushing part 32b extends from the annular receiving part 32a away from one end of the pressing part 31 to the support table 22b-2, and the number of pushing parts 32b is at least one.

[0095] The main part 42 is accommodated in the support table 22b-2 and the annular receiving part 32a respectively at the opposite ends. At least one positioning rod 41 is located between the support table 22b-2 and the annular receiving part 32a, and the projection of the positioning rod 41 along the moving direction of the microneedle 10 extends to the outside of the support table 22b-2 and the annular receiving part 32a. The support table 22b-2 plays a role of limiting the positioning rod 41, avoiding the movement of the microneedle 10 driven by the fixed rod 40 when the driving part 32 of the trigger 30 is not driven, thereby avoiding the misoperation of the microneedle 10.

[0096] A single pushing part 32b is located between a single positioning rod 41 and a single column 22b-1. The side of the pushing part 32b close to the column 22b-1 is a first inclined surface 32b-1, and the side of the pushing part 32b close to the positioning rod 41 is a second inclined surface 32b-2. The first inclined surface 32b-1 and the second inclined surface 32b-2 extend from the annular receiving part 32a to the direction of approaching each other to form the pushing part 32b, as shown in Figure 8 .

[0097] When the trigger 30 moves towards the base 22, the column 22b-1 pushes the first inclined surface 32b-1 of the pushing part 32b of the trigger 30 to make the trigger 30 rotate and in turn drive the second inclined surface 32b-2 to push the positioning rod 41 off the support table 22b-2, so that the fixed rod 40 drives the microneedle 10 to pierce the skin for sample collection.

[0098] It should be noted that the first slope 32b-1 of the pushing part 32b interacts with the column 22b-1 to convert the linear motion of the trigger 30 into rotation, and then the second slope 32b-2 of the pushing part 32b pushes the positioning rod 41 from one side of the support table 22b-2 to the bottom, thereby realizing that the fixed rod 40 drives the microneedle 10 to penetrate into the skin.

[0099] It can be understood that the above structure of the trigger 30 pushing the fixed rod 40 to move is only one specific embodiment of the present application, and in actual application, other structures can also be provided, for example, the top end of the fixed rod 40 is connected with the bottom end of the trigger 30, the fixed rod 40 is sleeved with a spring, one end of the spring abuts against the trigger 30, the other end of the spring abuts against the base, and the spring is in a compressed state, so that the top end of the driving part 32 of the trigger 30 abuts against the top end of the inner wall of the shell 20, and then the fixed rod 40 drives the microneedle 10 away from the skin; when the trigger 30 is pressed, the fixed rod 40 overcomes the elastic force of the spring and drives the microneedle 10 to penetrate into the skin.

[0100] Further, the present application discloses that the end of the support table 22b-2 away from the base 22 is partially recessed to form a recessed part 22c, the recessed part 22c is located on the side of the column 22b-1 close to the pushing part 32b and is spaced apart from the column 22b-1, and the pushing part 32b cooperates with the column 22b-1 to guide the positioning rod 41 to move from the end face of the accommodating part to the recessed part 22c.

[0101] The setting of the recessed part 22c effectively limits the depth of the microneedle 10 penetrating into the skin driven by the fixed rod 40, avoids the microneedle 10 penetrating too deep into the skin, and improves the safety in use.

[0102] Further, the present application discloses that at least two positioning rods 41 are uniformly and spaced apart along the circumference of the main body part 42 to realize stable support of the support table 22b-2 to the fixed rod 40.

[0103] The positioning rods 41 are correspondingly arranged with the pushing part 32b, the recessed part 22c and the column 22b-1 respectively.

[0104] Further, the present application discloses that the driving part 32 further comprises a limiting part 33, and the limiting part 33 extends from the annular accommodating part 32a away from the pressing part 31 to the support table 22b-2.

[0105] The limiting part 33 is spaced apart from the pushing part 32b and is used to limit the excessive rotation of the positioning rod 41 caused by the extrusion of the pushing part 32b.

[0106] Further, the present application discloses that the limiting part 33 and the pushing part 32b located on both sides of the same column 22b-1 are the same structure and are symmetrically arranged about the center axis of the driving part 32.

[0107] The present invention provides that the limiting part 33 and the pushing part 32b have the same structure and are arranged symmetrically.

[0108] To facilitate the positioning and installation of the reset elastic element 50, the present invention discloses that the reset elastic element 50 is sleeved on one end of the main body 42 and housed in the support platform 22b-2, and abuts against the base and the positioning rod 41.

[0109] In some embodiments, a surrounding wall protrudes from the side of the base near the trigger 30, and the surrounding wall and the base together form a storage pool 60. A groove 22d is formed in the side of the base 22 away from the trigger 30 around the sampling port 22a. The groove 22d communicates with the sampling port 22a. A communication hole communicating with the storage pool 60 is formed on the side wall of the groove 22d near the storage pool 60. In use, the side of the base 22 away from the trigger 30 abuts against the skin surface. When the microneedle 10 pierces into the skin, the overflowing sample enters the groove 22d and enters the storage pool 60 along the communication hole 64, thus realizing sample collection.

[0110] To facilitate the removal of blood from the storage pool 60, at least a portion of the sidewall of the storage pool 60 is a puncturable first puncturable sidewall 61, such as... Figure 4c As shown. Specifically, the first puncturable sidewall 61 is the sidewall of the storage pool 60 away from the sampling port 22a, and is made of a thin film.

[0111] like Figure 7 As shown, the upper cover 21 is provided with a puncturable second puncturable sidewall 21b at the position corresponding to the first puncturable sidewall 61, so as to extract the sample in the storage pool 60 through the second puncturable sidewall 21b and the first puncturable sidewall 61. Specifically, the second puncturable sidewall 21b is also made of a thin film material.

[0112] Furthermore, the present invention discloses that the storage pool 60 includes a first storage pool 62 and a second storage pool 63 arranged sequentially along a direction away from the sampling port 22a.

[0113] The outlet of the first storage pool 62 is connected to the inlet of the second storage pool 63. Along the direction of the storage pool 60 from the end connected to the base 22 to the end away from the base 22, the cross-section of the first storage pool 62 is smaller than the cross-section of the second storage pool 63, so that the blood entering the first storage pool 62 can quickly enter the second storage pool 63.

[0114] Further, the first storage pool 62 and the second storage pool 63 are both rectangular pools, and the top surface of the enclosing wall extends obliquely from the sampling port 22a to the direction away from the base, that is, the cross section of the storage pool 60 gradually increases in the direction away from the sampling port 22a, so as to facilitate the blood to quickly enter the storage pool 60. It can be understood that the cross section of the storage pool 60 here refers to the cross section of the storage pool 60 in the direction perpendicular to the storage pool 60 from the end close to the sampling port 22a to the end away from the sampling port 22a.

[0115] It can be understood that the storage pool 60 is not limited to the above structure, and can also be other shapes, such as a trapezoidal pool. Of course, in order to facilitate the sample in the storage tank 22e to quickly enter the storage pool 60, a negative pressure structure can be provided, and the negative pressure structure is used to start vacuumizing the gas in the groove 22d, so as to facilitate the sample in the storage pool 60 to enter the groove 22d.

[0116] In some embodiments, as shown in Figure 9 and Figure 10 The microneedle 10 includes a base 11 fixed to the fixed rod 40 and a needle body 12 away from the fixed rod 40 from the base 11. Specifically, the base 11 is in the form of a sheet, the number of needle bodies 12 is multiple, and the array is arranged at the bottom end of the base 11.

[0117] The microneedle 10 penetrates the skin through the array of multiple needle bodies 12, and reduces the pain during sampling on the basis of meeting the sampling amount.

[0118] When the sample collection device 100 samples, the microneedle 10 can be driven to penetrate the skin to sample.

[0119] It should be noted that the number of needle bodies 12 can meet the preset sampling amount. That is, according to the actual sampling amount required, a corresponding number of needle bodies 12 can be selected.

[0120] The microneedle 10 provided by the application, compared with the integrated venous blood needle and the integrated finger blood needle, the application adopts the array mode to array multiple needle bodies 12 at the bottom end of the base 11, divides the needle into multiple small size needle bodies 12, penetrates the skin through multiple needle bodies 12, reduces the penetration depth and the cross section of a single needle body 12, and further reduces the pain. That is, the application realizes reducing the pain during sampling on the basis of meeting the sampling amount.

[0121] It should be noted that herein, the bottom end of the needle body 12 refers to the end of the needle body 12 that penetrates the skin first, and the top end of the needle body 12 refers to the end of the needle body 12 close to the base 11.

[0122] In some embodiments, the plurality of needle bodies 12 are uniformly spaced apart from the base 11 and coplanar with the base 11, so as to facilitate the needle bodies 12 to be capable of simultaneously piercing the skin and uniformly piercing the skin, further reducing the pain.

[0123] In some embodiments, the length of the needle body 12 is greater than or equal to 800 microns and less than or equal to 1300 microns, the width of the needle body 12 is greater than or equal to 150 microns and less than or equal to 500 microns, and the thickness of the needle body 12 is greater than or equal to 20 microns and less than or equal to 50 microns.

[0124] It should be noted that the length of the needle body 12 refers to the length of the needle body 12 vertically piercing the skin, the width of the needle body 12 refers to the maximum width of the needle body 12, and the thickness of the needle body 12 refers to the maximum thickness of the needle body 12.

[0125] Compared with the size of the venous blood sampling needle and the finger blood sampling needle in the prior art, the size of the needle body 12 in the present application is significantly reduced, thereby reducing the pain during puncture.

[0126] In some embodiments, as shown in Figure 11 the needle body 12 includes a needle body 12a and a needle tip 12b, the top end of the needle body 12a is connected with the base 11, and the bottom end of the needle body 12a is connected with the needle tip 12b. It can be understood that the needle body 12a and the needle tip 12b are sequentially arranged in the direction from the top end to the bottom end of the needle body 12.

[0127] The cross section of the top end of the needle body 12a and the needle tip 12b is equal, and the needle body 12a and the needle tip 12b are coplanarly arranged.

[0128] In order to facilitate the needle body 12 to pierce the skin, the present application discloses that the cross section of the needle tip 12b gradually decreases in the direction from the top end to the bottom end of the needle tip 12b.

[0129] Further, as shown in Figures 13a-13c the present application discloses that the needle body 12a is a strip-shaped body with a rectangular, trapezoidal or hexagonal cross section.

[0130] It should be noted that the shape of the needle body 12a disclosed above is only some specific embodiments of the present application, and in actual application, the needle body 12a can also be provided as a triangular or irregularly shaped cross section and other shapes.

[0131] In order to facilitate the needle body 12a to pierce the skin, the present application discloses that the side wall edge of the needle body 12a is sharp.

[0132] As shown in Figures 12a-12cAs shown, the needle tip 12b is triangular, and specifically, the needle tip 12b can be an acute triangle or a right triangle. The acute angle a of the base end of the needle tip 12b is greater than or equal to 20° and less than or equal to 90°, so as to facilitate penetration into the skin.

[0133] It should be noted that the acute angle a of the base end of the needle tip 12b is not limited to the above range, and can be set to a value between 0° and 20°.

[0134] In addition, since the needle body 12 is in a sheet shape, the size of the needle body 12 is small, and the capillary vessels can also be cut, reducing the pain.

[0135] Further, the present application discloses that the radius of the acute angle of the base end of the needle tip 12b is greater than or equal to 1 micrometer and less than or equal to 50 micrometers.

[0136] In some embodiments, the base 11 is a ring structure formed by continuous material processing, and it can be understood that the ring structure here refers to a ring structure surrounding the circumference of the bottom end of the fixed rod 40 of the sample collection device 100.

[0137] Further, as shown, Figures 14a-14i The ring structure surrounded by the base 11 is a circular ring, an elliptical ring, a quadrilateral, a pentagon, a hexagon, a four-pointed star, a five-pointed star, a six-pointed star, or a triangle.

[0138] Specifically, the quadrilateral can be a rectangle, a square, a trapezoid, or a rhombus, etc.

[0139] It should be noted that the ring structure is not limited to the shapes disclosed above, and can also be other shapes.

[0140] In some embodiments, the needle body 12 is made of medical stainless steel, silicon, ceramic, or polymer, and the needle body 12 is processed by punching, etching, electric pulse, laser cutting, wire cutting, or numerical control machine tool.

[0141] Further, the present application discloses that the microneedle 10 is a one-piece structure, that is, the needle body 12 is integrally connected with the base 11, facilitating processing and manufacturing.

[0142] The microneedle 10 is arranged around the fixed rod 40 in a head-to-tail manner, and a gap is left between the two ends, and the base 11 is provided with a positioning hole 11a, so as to be connected with the fixed rod 40.

[0143] The second aspect of the present application provides a sample collection method, comprising: providing the sample collection device 100 in any one of the above embodiments; pressing the trigger 30, the trigger 30 extruding the driving elastic element 70, the driving part 32 cooperating with the guide 22b to guide the fixed rod 40 to move in the direction close to the skin, so that the fixed rod 40 drives the microneedle 10 to pierce the skin, and the sample flows into the storage pool 60 through the pierced skin, thereby realizing the collection of the sample.

[0144] Releasing the trigger 30, the first elastic element 50 resets, the driving fixed rod 40 drives the microneedle 10 to separate from the skin.

[0145] In some embodiments, the bottom end of the trigger 30 is provided with a pushing part 32b, the top end of the base 22 is provided with a column 22b-1 and a support table 22b-2, the support table 22b-2 supports the positioning rod 41, the trigger 30 extrudes the driving elastic element 70, the driving part 32 cooperates with the guide 22b to guide the fixed rod 40 to move in the direction close to the skin, and specifically includes: the trigger 30 moves downward, the column 22b-1 abuts against the first inclined surface 32b-1 of the pushing part 32b, the column 22b-1 pushes the first inclined surface 32b-1, so that the trigger 30 rotates to drive the second inclined surface 32b-2 of the pushing part 32b to push the positioning rod 41 to fall off from the support table 22b-2, so that the fixed rod 40 drives the microneedle 10 to pierce the skin.

[0146] It should be noted that the words indicating the direction in this paper are set in the direction of Figure 8 , only for the convenience of expression, and do not have other specific meanings.

[0147] The embodiments in the specification are described in a progressive manner, and each embodiment focuses on the difference from other embodiments. The same or similar parts between the embodiments can be referred to each other.

[0148] The above description of the disclosed embodiments enables a person skilled in the art to implement or use the present application. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to the embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

[0149] In the description of the specification, reference to "one embodiment", "an example", "a specific example" or the like means that a particular feature, structure, material or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the application. The appearances of the phrases "in one embodiment", "an example", "a specific example" or the like in various places in the specification are not necessarily referring to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics can be combined in any suitable manner in one or more embodiments or examples.

[0150] The preferred embodiments of the application disclosed above are only to help explain the application. The preferred embodiments do not describe all the details of the application and limit the application to the specific embodiments. Obviously, many modifications and variations can be made in light of the contents of the specification. The specification selects and specifically describes these embodiments in order to better explain the principles and practical application of the application, so that those skilled in the art can well understand and utilize the application. The application is limited only by the claims and their full scope and equivalents.

Claims

1. A sample collection device (100) characterized by, include: A hollow housing (20) includes a sampling port (22a) at one end thereof and a storage pool (60) in communication with the sampling port (22a). And a trigger (30), a fixing rod (40), a driving elastic element (70) and a microneedle (10) housed in the housing (20); The housing (20) has an operation hole (21a) corresponding to the trigger (30). The trigger (30) has a pressing part (31) extending through the operation hole (21a) to the outside of the housing (20) and a driving part (32) housed in the housing (20). The housing (20) has a guide (22b) that is opposite to and spaced apart from the driving part (32). The fixing rod (40) is housed between the driving part (32) and the guide (22b). The microneedle (10) is fixed at one end of the fixing rod (40) away from the trigger (30). The microneedle (10) can extend out of the housing (20) from the sampling port (22a). The driving elastic element (70) is sleeved on the fixed rod (40). After the trigger (30) is pressed, it squeezes the driving elastic element (70). The driving part (32) and the guide (22b) cooperate to guide the fixed rod (40) to drive the microneedle (10) to extend out of the shell (20) through the sampling port (22a) to puncture the skin for sample collection. The storage pool (60) is connected to the sampling port (22a) and is used to store the samples collected through the sampling port (22a); The fixing rod (40) includes a main body (42) extending along the moving direction of the microneedle (10) and at least one positioning rod (41) extending outward from the outside of the main body (42). The driving elastic element (70) is sleeved on the outside of the main body (42) and disposed between the positioning rod (41) and the trigger (30). The guide (22b) includes a support platform (22b-2) that surrounds the sampling port (22a) and extends toward the trigger (30) and at least one column (22b-1) that protrudes from the side wall of the support platform (22b-2). The support platform (22b-2) has a recessed portion (22c) at one end away from the sampling port (22a). The drive unit (32) includes an annular receiving portion (32a) that is opposite to and spaced apart from the support platform (22b-2) and at least one push portion (32b) that extends from one end of the annular receiving portion (32a) away from the pressing portion (31) toward the support platform (22b-2). The main body (42) is respectively housed in the support platform (22b-2) and the annular receiving part (32a) at its opposite ends. At least one of the positioning rods (41) is located between the support platform (22b-2) and the annular receiving part (32a), and its projection along the moving direction of the microneedle (10) extends to the outside of the support platform (22b-2) and the annular receiving part (32a). The recess (22c) is located on the side of the column (22b-1) near the pusher (32b) and is spaced apart from the column (22b-1). The pusher (32b) cooperates with the column (22b-1) to guide the positioning rod (41) from the end face of the annular receiving part (32a) to the recess (22c).

2. The sample collection device (100) as described in claim 1, characterized in that, The sample collection device (100) further includes a reset elastic element (50) sleeved on the end of the main body (42) away from the trigger (30) and located between the positioning rod (41) and the housing (20). The reset elastic element (50) is used to move the fixing rod (40) toward the trigger (30) to drive the microneedle (10) away from the skin.

3. The sample collection device (100) according to claim 2, characterized in that The housing (20) includes a top cover (21) and a base (22); The upper cover (21) is fastened to the base (22); The sampling port (22a) is opened on the base (22), the operation hole (21a) is opened on the upper cover (21), the size of the pressing part (31) is smaller than the diameter of the operation hole (21a), and the size of the driving part (32) is larger than the diameter of the operation hole (21a). The pressing part (31) extends at least partially outside the upper cover (21).

4. The sample collection device (100) according to claim 3, characterized in that A single pusher (32b) is located between a single positioning rod (41) and a single column (22b-1). The side of the pusher (32b) closest to the column (22b-1) is a first inclined surface (32b-1), and the side of the pusher (32b) closest to the positioning rod (41) is a second inclined surface (32b-2). The first inclined surface (32b-1) and the second inclined surface (32b-2) extend from the annular receiving portion (32a) in a direction that approaches each other to form the pusher (32b).

5. The sample collection device (100) according to claim 3, characterized in that At least two of the positioning rods (41) are evenly spaced along the circumference of the main body (42); The positioning rod (41) is respectively provided in correspondence with the pushing part (32b), the recessed part (22c) and the column (22b-1).

6. The sample collection device (100) according to claim 5, characterized in that The drive unit (32) also includes a limiting part (33) extending from one end of the annular receiving part (32a) away from the pressing part (31) toward the support platform (22b-2). The limiting part (33) and the pushing part (32b) are spaced apart to limit the positioning rod (41) from excessive rotation caused by the squeezing of the pushing part (32b).

7. The sample collection device (100) according to claim 6, characterized in that The reset elastic element (50) is sleeved on one end of the main body (42) and housed in the support platform (22b-2), abutting between the base (22) and the positioning rod (41).

8. The sample collection device (100) according to claim 6, characterized in that, The base (22) has a wall protruding on the side near the trigger (30), and the wall and the base (22) together form the storage pool (60). The base (22) has a recessed groove (22d) on the side away from the trigger (30) around the sampling port (22a). The groove (22d) communicates with the sampling port (22a). The groove (22d) has a communication hole (22d-1) on the side wall near the storage pool (60) that communicates with the storage pool (60).

9. The sample collection device (100) according to claim 8, characterized in that, At least a portion of the sidewall of the storage pool (60) is a puncturable first puncturable sidewall (61). The top cover (21) is provided with a second puncturable sidewall (21b) at the position corresponding to the first puncturable sidewall (61) so as to extract the sample in the storage pool (60) through the second puncturable sidewall (21b) and the first puncturable sidewall (61).

10. The sample collection device (100) according to any one of claims 1-9, characterized in that, The microneedle (10) includes a sheet-like substrate (11) fixed to the fixing rod (40) and a needle body (12) extending from the substrate (11) toward the direction away from the fixing rod (40).

11. The sample collection device (100) according to claim 10, characterized in that, Multiple needles (12) are evenly spaced on the substrate (11) and are coplanar with the substrate (11).

12. The sample collection device (100) according to claim 10, characterized in that, The needle body (12) has a length of 800-1300 micrometers, a width of 150-500 micrometers, and a thickness of 20-50 micrometers.

13. The sample collection device (100) according to claim 10, characterized in that, The microneedle (10) is a one-piece structure, and: it is wound around the fixing rod (40) in a way that the ends are connected, or there is a gap between the two ends; the base (11) has a positioning hole (11a) through it.

Images