Sterile sampling needle, sampling device and sterile sample transfer method

Abstract

The invention discloses a sterile sampling needle, a sampling device and a sterile sample transfer method. The sterile sampling needle comprises at least two puncture needles and at least two protective sleeves, the at least two puncture needles and the at least two protective sleeves are alternately arranged in sequence at intervals, the innermost layer of the sterile sampling needle is the puncture needle, and the outermost layer of the sterile sampling needle is the protective sleeve; the protective sleeve is provided with a sealing structure, the sealing structure is arranged at one end, sleeved with the protective sleeve, of the puncture end of the puncture needle in the selected direction, each puncture needle can be driven by external force to move relative to the adjacent protective sleeve in the selected direction, and when the puncture needle and the adjacent protective sleeve move relative to each other in the selected direction, the sealing structure can seal the puncture end of the puncture needle. The puncture needle can penetrate through the sealing structure and keep a sealing state with the sealing structure. According to the sterile sampling needle provided by the invention, a liquid medium can be transferred in a closed system as simply as possible, and the sterile sampling needle is particularly suitable for small-capacity sampling or liquid adding.

Description

Technical Field

[0001] The present invention particularly relates to a sterile sampling needle, a sampling device and a sterile sample transfer method for sampling and testing in the process of food and drug production and research and development, and belongs to the technical field of sampling and testing equipment. Background Art

[0002] In the process of drug production and research and development, aseptic sampling is an important step to effectively control microbial items and detect the growth status of biological samples. Sampling methods are generally divided into two types, repeated sampling and one-time sampling. Repeated sampling requires cleaning and sterilization of the pipeline, and there is a certain amount of waste of samples. Disposable sampling is currently mostly carried out in a sterile environment or connected with a sterile pipe connection machine or sterile connector, which is relatively expensive. At the same time, there is a certain amount of waste in the connecting pipeline and residues that affect the next sampling test.

[0003] Especially for small-volume laboratory biopharmaceuticals, aseptic addition or sampling in bioreactors. Because many biological preparations cannot be aseptically filtered or cannot be ultimately sterilized, the manufacture of such drugs is carried out in a sterile manner in a clean room of the corresponding clean room grade. Therefore, the addition of liquid media to the bioreactor or the transfer of liquid media between two culture medium vessels and / or bioreactors in principle contains the risk of contamination, so this operation step is usually performed in a clean room of clean room grade A (Appendix 1 of the GMP Manual) or ISO5 (ISO14644 1). However, the manufacture of drugs in such clean rooms is very expensive due to high monitoring requirements, expensive coating procedures, etc. Summary of the invention

[0004] In view of the above problems, especially for small-volume culture or expensive reagent culture, it is necessary to solve the residue and clean and sterilize. The main purpose of the present invention is to provide a sterile sampling needle, a sampling device and a sterile sample transfer method. The sterile sampling needle has a simple structure and is easy to use, which helps to avoid the risk of drug liquid contamination and waste. The sampling needle provided by the present invention can directly take samples from the sample container or directly add them to the sample container, without intermediate pipelines, and there is no residue and the need for cleaning and sterilization, thereby overcoming the shortcomings of the prior art.

[0005] In order to achieve the above-mentioned invention object, the technical solution adopted by the present invention includes:

[0006] In one aspect, the present invention provides a sterile sampling needle, comprising:

[0007] At least two puncture needles and at least two protective sleeves, the at least two puncture needles and at least two protective sleeves are alternately arranged in sequence from the inside to the outside along the radial direction of the sterile sampling needle and are mutually sleeved, the innermost layer of the sterile sampling needle is the puncture needle, and the outermost layer is the protective sleeve;

[0008] The protective sleeve has a sealing structure, which is arranged along a selected direction at one end of the puncture end of the puncture needle covered by the protective sleeve. Each puncture needle can move relative to an adjacent protective sleeve along the selected direction under the driving of an external force, and when the puncture needle and an adjacent protective sleeve move relative to each other along the selected direction, the puncture needle can pass through the sealing structure and maintain a sealed state with the sealing structure.

[0009] In a more specific embodiment, at least two of the puncture needles include an inner needle and an outer needle, at least two of the protective covers include a first protective cover and a second protective cover, the first protective cover includes a first telescopic structure and a second telescopic structure, the first telescopic structure and the second telescopic structure are both capable of telescoping along a selected direction, and the first telescopic structure has a first sealing structure that can be pierced by the outer needle;

[0010] The outer needle, the second protective sleeve and the inner needle are sealed and packaged in the first protective sleeve, the second protective sleeve is arranged between the inner needle and the outer needle, the second puncture end of the inner needle is wrapped by the second protective sleeve, the second protective sleeve is fixedly matched with the outer needle and movably matched with the inner needle, the second protective sleeve also has a second sealing structure through which the inner needle can pass, the outer needle is fixedly connected to the first protective sleeve and movably matched with the first telescopic structure, and the inner needle is also fixedly connected to the second telescopic structure;

[0011] When the first telescopic structure is extended or retracted along the selected direction, the outer needle and the first telescopic structure move relative to each other along the selected direction, and the first puncture end of the outer needle can pass through the first sealing structure and extend from the first protective cover; when the second telescopic structure is extended or retracted along the selected direction, the inner needle and the outer needle move relative to each other along the selected direction, and the second puncture end of the inner needle can pass through the second sealing structure and extend from the outer needle.

[0012] On the other hand, the present invention also provides a sampling capsule for use with the sterile sampling needle. The sampling capsule includes at least two rubber plugs spaced apart along a selected direction. The at least two rubber plugs are connected in sequence and sealed to form at least one closed air chamber between any two adjacent rubber plugs. The rubber plug is a flexible structure that can be pierced by the puncture needle and can undergo recoverable deformation when compressed. When the puncture needle passes through the rubber plug, the rubber plug and the puncture needle maintain a sealed and fitted state.

[0013] Another aspect of the present invention further provides a sterile sampling device, comprising:

[0014] The liquid collector and the sterile sampling needle, the liquid collector has a liquid collecting chamber, the liquid collecting chamber is connected with the inner needle, and the pressure in the liquid collecting chamber is adjustable.

[0015] Another aspect of the present invention further provides a sterile sampling device, comprising:

[0016] A liquid collector and the sterile sampling needle, wherein the liquid collector has a liquid collecting chamber, the liquid collecting chamber is connected to the inner needle, and the pressure in the liquid collecting chamber is adjustable;

[0017] The sampling capsule comprises at least two rubber plugs spaced apart along a selected direction, wherein the at least two rubber plugs are sequentially connected and sealed to form at least one closed air chamber between any two adjacent rubber plugs, wherein the rubber plug is a flexible structure capable of being pierced by the puncture needle and capable of recovering its deformation when compressed, and when the puncture needle passes through the rubber plug, the rubber plug and the puncture needle maintain a sealed fit state.

[0018] Another aspect of the present invention also provides a sterile sample transfer method, comprising:

[0019] Providing the sterile sampling device;

[0020] The first sealing structure of the sterile sampling needle is brought into contact with the sample container, and a thrust is applied to the sterile sampling needle along the selected direction, so that the first telescopic structure is contracted along the selected direction, the first sealing structure is sealed and fitted with the sample container, and the outer needle sequentially pierces the first sealing structure and the sample container, and then the second telescopic structure is contracted along the selected direction, the inner needle sequentially pierces the second sealing structure and extends from the outer needle to enter the interior of the sample container;

[0021] Allow the liquid in the sample container to flow into the liquid collector along the inner needle, or allow the liquid in the liquid collector to flow into the sample container along the inner needle;

[0022] Gradually removing the thrust, so that the second telescopic structure expands along the selected direction, and the inner needle retreats into the second protective cover along the selected direction; then, expanding the first telescopic structure along the selected direction, and the outer needle retreats into the first protective cover along the selected direction;

[0023] Alternatively, the aseptic sampling device is provided, wherein the sampling capsule is arranged on a sample container, the inner rubber plug is arranged inside the sample container, and the outer rubber plug is arranged outside the sample container;

[0024] The first sealing structure of the sterile sampling needle is brought into contact with the outer rubber plug, and a thrust is applied to the sterile sampling needle along the selected direction, so that the first telescopic structure is contracted along the selected direction, the first sealing structure is sealed and fitted with the outer rubber plug, and the outer needle sequentially pierces the first sealing structure and the outer rubber plug and enters the air chamber, and then the second telescopic structure is contracted along the selected direction, and the inner needle sequentially pierces the second sealing structure and the inner rubber plug and enters the interior of the sample container;

[0025] Allow the liquid in the sample container to flow into the liquid collector along the inner needle, or allow the liquid in the liquid collector to flow into the sample container along the inner needle;

[0026] The thrust is gradually removed to expand the second telescopic structure along the selected direction, and the inner needle is retracted into the second protective cover along the selected direction. Then, the first telescopic structure is expanded along the selected direction, and the outer needle is retracted into the first protective cover along the selected direction.

[0027] Compared with the prior art, the advantages of the present invention include:

[0028] 1) The sterile sampling needle provided by the present invention forms a static sealing structure to the outside world through multiple layers of nested puncture needles and protective sleeves. Compared with the dynamic sealing structure of a direct syringe, there is no risk of cross-zone contamination. When sampling with the sterile sampling needle provided by the present invention, it can be ensured that the inner needle of the innermost layer will not contact the air in the internal air chamber of the sampling plug, the outer needle head, etc., further reducing the risk of contamination during sampling.

[0029] 2) The sterile sampling needle provided by the present invention can transfer liquid media in a closed system in the simplest way possible, and is particularly suitable for small-volume sampling or liquid addition. The sterile sampling method implemented based on the sterile sampling needle can greatly save costs and improve the convenience of sampling or liquid addition.

[0030] 3) The sterile sampling needle provided by the present invention has a sterile puncture structure and a fully enclosed sampling needle structure, so that sampling of the equipment does not require cumbersome cleaning, sterilization, purging or sterile connection structure, and can be directly obtained from the reactor container, which is convenient, fast and sterile. At the same time, after the sampling is completed, the sample is directly sealed, thereby avoiding the risk of sampling container contamination and sample contamination.

[0031] 4) The sampling rubber plug provided by the present invention has a double-layer structure and one or more sterile bag structures, which can be used in conjunction with a sterile sampling needle to further reduce the risk of liquid medium contacting the external environment during sampling. At the same time, multiple sampling can be achieved. The sampling rubber plug in the present invention can be used in disposable sample containers and can also be used in reusable sample containers and replaced.

[0032] 5) The raised structure of the outer plug of the sampling plug provided by the present invention can facilitate identification of the position of the air chamber inside the sampling plug, and at the same time, exhaust air when in contact with the outermost protective cover of the sterile sampling needle, further reducing the risk of contamination during the sampling process.

[0033] 6) The aseptic sampling device provided by the present invention only needs to reserve a sampling plug position in advance for installation, and directly extracts or adds liquid from a closed container without any intermediate pipeline, and there is no waste of liquid medium. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 It is a schematic structural diagram of a sterile sampling device provided by the present invention;

[0035] Figure 2 It is a schematic structural diagram of another aseptic sampling device provided by the present invention;

[0036] Figure 3 is a schematic structural diagram of another sample container provided by the present invention;

[0037] Figure 4 is a schematic structural diagram of another sample container provided by the present invention;

[0038] Figure 5 It is a schematic structural diagram of the case where the outer rubber plug is pierced when sampling is performed using a sterile sampling device provided by the present invention;

[0039] Figure 6 It is a schematic structural diagram of a case where an inner rubber plug is pierced when sampling is performed using a sterile sampling device provided by the present invention. DETAILED DESCRIPTION

[0040] In view of the deficiencies in the prior art, the inventor of this case has proposed the technical solution of the present invention after long-term research and extensive practice. The technical solution, its implementation process and principle will be further explained as follows.

[0041] In one aspect, the present invention provides a sterile sampling needle, comprising:

[0042] At least two puncture needles and at least two protective sleeves, the at least two puncture needles and at least two protective sleeves are alternately arranged in sequence from the inside to the outside along the radial direction of the sterile sampling needle and are mutually sleeved, the innermost layer of the sterile sampling needle is the puncture needle, and the outermost layer is the protective sleeve;

[0043] The protective sleeve has a sealing structure, which is arranged along a selected direction at one end of the puncture end of the puncture needle covered by the protective sleeve. Each puncture needle can move relative to an adjacent protective sleeve along the selected direction under the driving of an external force, and when the puncture needle and an adjacent protective sleeve move relative to each other along the selected direction, the puncture needle can pass through the sealing structure and maintain a sealed state with the sealing structure.

[0044] Furthermore, each of the puncture needles is covered by a protective cover, and any two puncture needles are isolated from each other by the protective cover.

[0045] In a more specific embodiment, at least two of the puncture needles include an inner needle and an outer needle, and at least two of the protective covers include a first protective cover and a second protective cover.

[0046] The first protective sleeve comprises a first telescopic structure and a second telescopic structure, both of which can be telescoped along a selected direction, and the first telescopic structure has a first sealing structure that can be pierced by an external needle;

[0047] The outer needle, the second protective sleeve and the inner needle are sealed and packaged in the first protective sleeve, the second protective sleeve is arranged between the inner needle and the outer needle, the second puncture end of the inner needle is wrapped by the second protective sleeve, the second protective sleeve is fixedly matched with the outer needle and movably matched with the inner needle, the second protective sleeve also has a second sealing structure through which the inner needle can pass, the outer needle is fixedly connected to the first protective sleeve and movably matched with the first telescopic structure, and the inner needle is also fixedly connected to the second telescopic structure;

[0048] When the first telescopic structure is extended or retracted along the selected direction, the outer needle and the first telescopic structure move relative to each other along the selected direction, and the first puncture end of the outer needle can pass through the first sealing structure and extend from the first protective cover; when the second telescopic structure is extended or retracted along the selected direction, the inner needle and the outer needle move relative to each other along the selected direction, and the second puncture end of the inner needle can pass through the second sealing structure and extend from the outer needle.

[0049] Furthermore, the first sealing structure is a flexible structure that can be punctured and can recover when compressed, and when the outer needle passes through the first sealing structure, the first sealing structure and the outer needle maintain a sealed cooperation state, and when the outer needle is separated from the first sealing structure, the first sealing structure can shrink and maintain its own sealing state.

[0050] Furthermore, the first sealing structure is arranged at one end of the first protective sleeve along the selected direction.

[0051] Furthermore, the first sealing structure is arranged at one end of the first telescopic structure along the selected direction.

[0052] Furthermore, the second sealing structure is a flexible structure that can be punctured and can recover when compressed, and when the inner needle passes through the second sealing structure, the second sealing structure and the inner needle maintain a sealed cooperation state, and when the inner needle is separated from the second sealing structure, the second sealing structure can shrink and maintain its own sealing state.

[0053] Furthermore, the second sealing structure is arranged at one end of the second protective sleeve along the selected direction.

[0054] Furthermore, the first telescopic structure and the second telescopic structure are arranged sequentially along the selected direction.

[0055] Furthermore, the first protective cover also includes a connecting structure, which is disposed between the first telescopic structure and the second telescopic structure along the selected direction and is fixedly connected to the first telescopic structure and the second telescopic structure.

[0056] Furthermore, the connection structure is rigid.

[0057] Furthermore, the sterile sampling needle also includes an outer needle holding mechanism, which is fixedly arranged on the outside of the outer needle, and the outer needle holding mechanism is movably cooperated with the first telescopic structure. The outer needle holding mechanism can interfere with the first telescopic structure along the selected direction, and form a stop structure with the first telescopic structure to limit the relative movement of the outer needle and the first telescopic structure along the selected direction.

[0058] Further, the outer needle includes a first part and a second part which are sequentially arranged along the selected direction, the first part is close to the first sealing structure, and the outer needle holding mechanism is arranged on the second part.

[0059] Furthermore, the outer needle holding mechanism is sleeved on the outside of the outer needle.

[0060] Furthermore, the outer needle holding mechanism is fixedly connected to the connecting structure.

[0061] Furthermore, the outer needle holding mechanism is integrated with the connecting structure.

[0062] Furthermore, the second protective cover is fixedly matched with the outer needle, or the second protective cover is movably matched with the outer needle, and the second protective cover is also connected to the second telescopic structure;

[0063] When the second telescopic structure is extended and retracted along the selected direction, the inner needle and the second protective cover, as well as the second protective cover and the outer needle all move relative to each other along the selected direction, and the relative movement distance between the inner needle and the second protective cover is greater than the relative movement distance between the second protective cover and the outer needle.

[0064] Furthermore, the sterile sampling needle also includes a needle seat, and the needle seat is fixedly connected to the inner needle and the second telescopic structure.

[0065] Furthermore, the selected direction is the axial direction of the sterile sampling needle.

[0066] Furthermore, the inside of the first protective sleeve, the outer needle, the second protective sleeve and the inner needle are coaxially arranged.

[0067] On the other hand, the present invention also provides a sampling capsule for use with the sterile sampling needle. The sampling capsule includes at least two rubber plugs spaced apart along a selected direction. The at least two rubber plugs are connected in sequence and sealed to form at least one closed air chamber between any two adjacent rubber plugs. The rubber plug is a flexible structure that can be pierced by the puncture needle and can undergo recoverable deformation when compressed. When the puncture needle passes through the rubber plug, the rubber plug and the puncture needle maintain a sealed and fitted state.

[0068] Furthermore, a protruding structure is provided on the side of the outermost rubber plug facing away from the air chamber. When the protective sleeve contacts the protruding structure, the protective sleeve is deformed under pressure and seals with the protruding structure.

[0069] Furthermore, the protruding structure is a flexible structure.

[0070] Furthermore, a plurality of air chambers isolated from each other are provided between two adjacent rubber plugs, and a plurality of the protruding structures are provided on the rubber plug located on the outermost layer, and the protruding structures correspond to the air chambers one by one.

[0071] In a more specific embodiment, the sampling capsule has an inner rubber plug, an outer rubber plug and a closed air chamber that are relatively arranged, and the air chamber is located between the inner rubber plug structure and the outer rubber plug structure. The inner rubber plug and the outer rubber plug are flexible structures that can be pierced by the inner needle or the outer needle and can undergo recoverable deformation when compressed, and when the inner needle or the outer needle passes through the inner rubber plug or the outer rubber plug, the inner rubber plug or the outer rubber plug maintains a sealed fit with the inner needle or the outer needle.

[0072] Furthermore, a protruding structure is provided on the side of the outer rubber plug facing away from the air chamber, and the protruding structure corresponds to the air chamber. When the first sealing structure on the first protective cover contacts the protruding structure, the first sealing structure is deformed under pressure and seals with the protruding structure.

[0073] Another aspect of the present invention further provides a sterile sampling device, comprising:

[0074] The liquid collector and the sterile sampling needle, the liquid collector has a liquid collecting chamber, the liquid collecting chamber is connected with the inner needle, and the pressure in the liquid collecting chamber is adjustable.

[0075] Another aspect of the present invention further provides a sterile sampling device, comprising:

[0076] A liquid collector and the sterile sampling needle, wherein the liquid collector has a liquid collecting chamber, the liquid collecting chamber is connected to the inner needle, and the pressure in the liquid collecting chamber is adjustable;

[0077] The sampling capsule comprises at least two rubber plugs spaced apart along a selected direction, wherein the at least two rubber plugs are sequentially connected and sealed to form at least one closed air chamber between any two adjacent rubber plugs, wherein the rubber plug is a flexible structure capable of being pierced by the puncture needle and capable of recovering its deformation when compressed, and when the puncture needle passes through the rubber plug, the rubber plug and the puncture needle maintain a sealed fit state.

[0078] Furthermore, a protruding structure is provided on the side of the outermost rubber plug facing away from the air chamber. When the protective sleeve contacts the protruding structure, the protective sleeve is deformed under pressure and seals with the protruding structure.

[0079] Furthermore, the protruding structure is a flexible structure.

[0080] Furthermore, a plurality of air chambers isolated from each other are provided between two adjacent rubber plugs, and a plurality of the protruding structures are provided on the rubber plug located on the outermost layer, and the protruding structures correspond to the air chambers one by one.

[0081] Furthermore, the liquid collector includes a syringe or a balloon whose volume is adjustable.

[0082] Furthermore, the sterile sampling device also includes a catheter, and the liquid collector is connected to the innermost inner needle of the sterile sampling needle via the catheter.

[0083] Another aspect of the present invention also provides a sterile sample transfer method, comprising:

[0084] Providing the sterile sampling device;

[0085] The first sealing structure of the sterile sampling needle is brought into contact with the sample container, and a thrust is applied to the sterile sampling needle along the selected direction, so that the first telescopic structure is contracted along the selected direction, the first sealing structure is sealed and fitted with the sample container, and the outer needle sequentially pierces the first sealing structure and the sample container, and then the second telescopic structure is contracted along the selected direction, the inner needle sequentially pierces the second sealing structure and extends from the outer needle to enter the interior of the sample container;

[0086] Allow the liquid in the sample container to flow into the liquid collector along the inner needle, or allow the liquid in the liquid collector to flow into the sample container along the inner needle;

[0087] Gradually removing the thrust, so that the second telescopic structure expands along the selected direction, and the inner needle retreats into the second protective cover along the selected direction; then, expanding the first telescopic structure along the selected direction, and the outer needle retreats into the first protective cover along the selected direction;

[0088] Alternatively, the aseptic sampling device is provided, wherein the sampling capsule is arranged on a sample container, the inner rubber plug is arranged inside the sample container, and the outer rubber plug is arranged outside the sample container;

[0089] The first sealing structure of the sterile sampling needle is brought into contact with the outer rubber plug, and a thrust is applied to the sterile sampling needle along the selected direction, so that the first telescopic structure is contracted along the selected direction, the first sealing structure is sealed and fitted with the outer rubber plug, and the outer needle sequentially pierces the first sealing structure and the outer rubber plug and enters the air chamber, and then the second telescopic structure is contracted along the selected direction, and the inner needle sequentially pierces the second sealing structure and the inner rubber plug and enters the interior of the sample container;

[0090] Allow the liquid in the sample container to flow into the liquid collector along the inner needle, or allow the liquid in the liquid collector to flow into the sample container along the inner needle;

[0091] The thrust is gradually removed to expand the second telescopic structure along the selected direction, and the inner needle is retracted into the second protective cover along the selected direction. Then, the first telescopic structure is expanded along the selected direction, and the outer needle is retracted into the first protective cover along the selected direction.

[0092] The technical solution, its implementation process and principles, etc. will be further explained below in conjunction with the accompanying drawings and specific implementation cases. Unless otherwise specified, the sterile sampling needles, sampling devices, etc. in the embodiments of the present invention can be obtained by conventional processes known to those skilled in the art, and their materials all meet sterile conditions.

[0093] Example 1

[0094] See also Figure 1 and Figure 2 A sterile sampling device includes a sampling needle 100 and a liquid collector 200, wherein the sampling needle 100 is connected to the liquid collector 200 and communicates with a liquid collecting chamber in the liquid collector 200, wherein the sampling needle 100 is used to pierce a sample container and transfer a liquid medium between the liquid collector 200 and the sample container. It should be noted that when piercing the sample container, the sampling needle 100 can maintain a sealed state with the sample container and the liquid collector 200, thereby realizing the sterile transfer of the liquid medium between the liquid collector 200 and the sample container.

[0095] Specifically, the sampling needle 100 includes a first protective sleeve 110 (also referred to as an outer protective sleeve or an outer needle protective sleeve, the same below), an outer needle 120, a second protective sleeve 130 (also referred to as an inner protective sleeve or an inner needle protective sleeve, the same below), an inner needle 140 and a needle seat 150. The outer needle 120, the second protective sleeve 130 and the inner needle 140 are sealed and packaged inside the first protective sleeve 110. The outer needle 120 is fixedly connected to the first protective sleeve 110. The outer needle 120 is sleeved on the outside of the second protective sleeve 130. The second protective sleeve 130 is sleeved on the outside of the inner needle 140. The inner needle 140 is fixedly connected to the needle seat 150. The needle seat 150 is fixedly connected to the first protective sleeve 110 and is used to connect and conduct the inner needle 140 and the liquid collector 200.

[0096] It can be understood that, specifically, the needle seat 150 can be connected to the liquid collector 200 via the needle seat connector 170. Specifically, the needle seat 150 can be fixedly connected to the first protective cover 110 via the needle seat connector 170, and at least part of the needle seat connector 170 is arranged outside the first protective cover 110.

[0097] It should be noted that when transferring the liquid medium, the outer needle 120, the second protective cover 130 and the inner needle 140 mainly perform the puncture action. Therefore, the outer needle 120, the second protective cover 130 and the inner needle 140 can be referred to as a puncture mechanism.

[0098] Specifically, the first protective cover 110 includes a first telescopic structure 111, a connecting structure 113 and a second telescopic structure 112 which are sequentially arranged along a selected direction. The first telescopic structure 111 and the second telescopic structure 112 can both telescope along the selected direction when pressure is applied along the selected direction, while the connecting structure 113 can maintain its original shape, that is, the connecting structure 113 can be rigid.

[0099] Specifically, the front end of the first telescopic structure 111 has a first sealing structure 1110 that can be punctured. It should be noted that the first sealing structure 1110 is a flexible structure that can undergo recoverable deformation under external pressure, so as to ensure that the first sealing structure 1110 can be punctured by the outer needle 120, and after being punctured by the outer needle 120, it can be adaptively sealed and fit with the outer needle 120, so as to maintain the sealed state inside the first protective cover 110. Of course, a slit for the outer needle 120 to pass through can also be pre-set on the first sealing structure 1110, but when it is not punctured, due to its own flexible structure, the slit can be kept sealed to the outside. When the outer needle 120 passes through the slit, the first sealing structure 1110 is adaptively sealed and fit with the outer needle 120. Exemplarily, the first sealing structure 1110 can be a flexible rubber head.

[0100] That is, the first sealing structure 1110 is a flexible structure that can be punctured and can recover when compressed, and when the outer needle 120 passes through the first sealing structure 1110, the first sealing structure 1110 and the outer needle 120 maintain a sealed cooperation state, and when the outer needle 120 is separated from the first sealing structure 1110, the first sealing structure 1110 can shrink and maintain its own sealing state.

[0101] Specifically, the needle seat 150 is located at the rear end of the first protective cover 110, that is, the needle seat 150 and the first sealing structure 1110 are arranged relatively along a selected direction, and the front end of the first protective cover 110 is the end that contacts the sample container when performing the sampling action.

[0102] Specifically, the end of the outer needle 120 facing the first sealing structure 1110 is the first puncture end. The outer needle 120 is fixedly connected to the connecting structure 113 of the first protective cover 110, and is movably cooperated with the first telescopic structure 111, that is, when the first telescopic structure 111 is telescoped along a selected direction, the outer needle 120 and the first telescopic structure 111 move relative to each other along the selected direction, and the first puncture end of the outer needle 120 can pass through the first sealing structure 1110 and extend from the first protective cover 110.

[0103] Specifically, the second protective cover 130 is mainly used to protect and isolate the inner needle 140 and the outer needle 120. The front end of the second protective cover 130 facing the first sealing structure 1110 has a second sealing structure 131 that can be pierced by the inner needle 140. The second protective cover 130 is fixedly matched with the outer needle 120, or the second protective cover 130 is movably matched with the outer needle 120. The second protective cover 130 is also connected to the second telescopic structure 112; when the second telescopic structure 112 is telescoped along a selected direction, the inner needle 140 and the second protective cover 130, as well as the second protective cover 130 and the outer needle 120, all move relative to each other along the selected direction, and the relative movement distance between the inner needle 140 and the second protective cover 130 is greater than the relative movement distance between the second protective cover 130 and the outer needle 120.

[0104] It should be noted that the second sealing structure 131 is a flexible structure that can undergo recoverable deformation under external pressure, thereby ensuring that the second sealing structure 131 can be punctured by the outer needle 120, and after being punctured by the inner needle 140, it can be adaptively sealed and fitted with the inner needle 140, thereby keeping the inner needle 140 and the outer needle 120 sealed and isolated by the second protective cover 130. Of course, a slit for the inner needle 140 to pass through can also be pre-set on the second sealing structure 131, but when it is not punctured, due to its own flexible structure, the slit can be kept sealed to the outside. When the inner needle 140 passes through the slit, the second sealing structure 131 and the inner needle 140 are adaptively sealed and fitted. Exemplarily, the second sealing structure 131 can be a flexible rubber head.

[0105] That is, the second sealing structure 131 is a flexible structure that can be punctured and can recover when compressed, and when the inner needle 140 passes through the second sealing structure 131, the second sealing structure 131 and the inner needle 140 maintain a sealed cooperation state, and when the inner needle 140 is separated from the second sealing structure 131, the second sealing structure 131 can shrink and maintain its own sealing state.

[0106] Specifically, the end of the inner needle 140 facing the first sealing structure 1110 is the second puncture end. The inner needle 140 is fixedly connected to the second telescopic structure 112 of the first protective cover 110 and movably cooperates with other parts of the first protective cover 110. When the second telescopic structure 112 is telescoped along a selected direction, the outer needle 120 and the second telescopic structure 112 move relative to each other along the selected direction, and the second puncture end of the inner needle 140 can pass through the second sealing structure 131 and extend from the second protective cover 130.

[0107] Specifically, the sampling needle 100 also includes an outer needle holding mechanism 160, which is fixedly arranged on the outside of the outer needle 120. The outer needle holding mechanism 160 is movably cooperated with the first telescopic structure 111. The outer needle holding mechanism 160 can interfere with the first telescopic structure 111 along a selected direction, and form a stop structure with the first telescopic structure 111 to limit the relative movement of the outer needle 120 and the first telescopic structure 111 along the selected direction.

[0108] Specifically, the function of the outer needle holding mechanism 160 is to limit the relative movement distance of the outer needle 120 and the first telescopic structure 111 in the selected direction, that is, the relative displacement. More specifically, the outer needle 120 is fixedly connected to the connecting structure 113 of the first protective cover 110 via the outer needle holding mechanism 160, that is, the outer needle holding mechanism 160 also provides a fixed support function for the outer needle 120. Of course, the outer needle holding mechanism 160 can be integrated with the connecting structure 113. It can be understood that the outer needle holding mechanism 160 should be rigid, that is, the outer needle holding mechanism 160 will not be significantly deformed when it is compressed.

[0109] Specifically, the outer needle 120 includes a first portion and a second portion sequentially arranged along a selected direction, the first portion is close to the first sealing structure 1110, and the outer needle holding mechanism 160 is arranged on the second portion.

[0110] Specifically, the outer needle holding mechanism 160 may be a cylindrical structure, and the outer needle holding mechanism 160 is sleeved on the outside of the outer needle 120 .

[0111] Specifically, the needle seat 150 is also fixedly connected to the second telescopic structure 112, that is, when the second telescopic structure 112 is extended or retracted, the needle seat 150, the inner needle 140 and the second protective cover 130 can all move along the selected direction, wherein the needle seat 150 and the inner needle 140 move synchronously.

[0112] Specifically, the selected direction is the axial direction of the sampling needle 100. It should be noted that, in the selected direction, the elastic restoring force provided by the first telescopic structure 111 itself is smaller than the elastic restoring force provided by the second telescopic structure 112 itself, so that when the sampling needle 100 contacts the sample and is subjected to a thrust applied along the selected direction, the first telescopic structure 111 will be compressed before the second telescopic structure 112.

[0113] Specifically, the inner and outer needles 120 of the first protective sleeve 110 , the second protective sleeve 130 and the inner needle 140 may be coaxially arranged.

[0114] Specifically, the liquid collector 200 has a liquid collecting chamber inside, which is connected to the inner needle 140, and the pressure in the liquid collecting chamber is adjustable. By changing the pressure in the liquid collecting chamber, an air pressure difference is formed between the liquid collecting chamber and the chamber inside the sample container. Driven by the air pressure difference, the liquid medium can be transferred along the inner needle 140 between the liquid collector and the sample container. Exemplarily, the liquid collector can be a piston syringe or a balloon, etc.

[0115] Example 1 provides a case including two puncture needles and two protective covers. It should be noted that the sterile sampling needle can of course also be set to more than three puncture needles, and correspondingly, the outside of each puncture needle is covered with a protective cover.

[0116] Example 2

[0117] See also Figure 3 A sample container 400 is provided with a sampling capsule 300. The sampling capsule 300 cooperates with the sampling needle in Example 1 to achieve aseptic sampling, thereby further reducing the risk of contamination during the sampling process.

[0118] Specifically, the sampling capsule 300 has an inner rubber plug 310, an outer rubber plug 320 and a sealed air chamber (i.e., a sterile capsule) 330 that are relatively arranged. The air chamber 330 is located between the inner rubber plug 310 structure and the outer rubber plug 320 structure. The inner rubber plug 310 and the outer rubber plug 320 are flexible structures that can be pierced by the inner needle 140 or the outer needle 120 and can undergo recoverable deformation when compressed. When the inner needle 140 or the outer needle 120 passes through the inner rubber plug 310 or the outer rubber plug 320, the inner rubber plug 310 or the outer rubber plug 320 maintains a sealed matching state with the inner needle 140 or the outer needle 120. It can be understood that the air chamber 330 is formed by the inner rubber plug 310 and the outer rubber plug 320.

[0119] Specifically, the inner rubber plug 310 is disposed inside the sample container, and the outer rubber plug 320 is disposed outside the sample container.

[0120] Specifically, a protruding structure 340 is further provided on the side of the outer rubber plug 320 facing away from the air chamber 330. The protruding structure 340 corresponds to the air chamber 330. When the first sealing structure 1110 on the first protective cover 110 contacts the protruding structure 340, the first sealing structure 1110 is deformed under pressure and seals with the protruding structure 340. The protruding structure 340 can be used to identify the position of the air chamber 330 on the one hand, and on the other hand, the protruding structure 340 can be adaptively contacted with the first sealing structure 1110 and isolate the air at the contact interface between the two to prevent the inner needle or the outer needle from contacting with the external environment and being contaminated.

[0121] Specifically, the protruding structure 340 may also be a flexible structure. When the first sealing structure 1110 and the protruding structure 340 are in contact and squeezed, the two can undergo adaptive deformation, thereby making the two fit together without a gap.

[0122] Specifically, the sampling capsule 300 may be provided with a plurality of air chambers 330 , which are isolated from each other, and the outer rubber plug 320 may be provided with a plurality of protruding structures 340 , which correspond one to one to the air chambers 330 .

[0123] Exemplarily, the sampling capsule 300 may be a silicone structure.

[0124] Specifically, the sample container 400 may include a container body and a container cover, wherein the container cover is openably disposed on the container body and is sealed with the container body, wherein the sampling capsule 300 may be disposed on the container body.

[0125] The sampling rubber plug provided by the present invention has a double-layer structure and one or more sterile bag structures, which can be used in conjunction with a sterile sampling needle to further reduce the risk of liquid medium contacting the external environment during sampling. At the same time, multiple sampling can be achieved. The sampling rubber plug in the present invention can be used in disposable sample containers and can also be used in reusable sample containers and replaced.

[0126] Example 3

[0127] See also Figure 5 and Figure 6 A method for aseptic sample transfer is implemented by using the aseptic sampling device in Example 1 and the sample container 400 in Example 2. The method for aseptic sample transfer specifically includes:

[0128] Align the sampling needle with the protruding structure 340 on the sampling capsule 300, so that the first sealing structure 1110 of the sampling needle contacts the protruding structure 340, and apply a thrust to the sampling needle along a selected direction to make the first telescopic structure contract along the selected direction, so that the first sealing structure 1110 and the protruding structure 340 are in close contact and the air on the contact interface is removed;

[0129] The first telescopic structure of the first protective sleeve stops moving forward after contacting the sampling capsule 300, and the outer needle 120 continues moving forward relative to the first telescopic structure, piercing the first sealing structure 1110 and the outer rubber plug 320 in sequence and entering the air chamber 330. At this time, the second protective sleeve and the inner needle 140 sleeved in the outer needle 120 also enter the air chamber 330 along with the outer needle 120. When the outer needle holding mechanism conflicts with the first protective sleeve along the selected direction, the outer needle no longer moves forward.

[0130] Continue to apply thrust to the sampling needle in the selected direction, so that the second telescopic structure contracts in the selected direction, and the inner needle 140 drives the second protective sleeve to continue to move forward. When the second protective sleeve contacts the inner rubber plug 310, it stops moving forward. The inner needle 140 pierces the second sealing structure 131 and the inner rubber plug 310 in sequence and enters the interior of the sample container. Figure 6 As shown, the sampling needle completes the puncture of the sampling capsule 300;

[0131] The liquid collector and the sample container are connected via the inner needle 140, and the liquid medium can be transferred between the liquid collector and the sample container along the inner needle 140;

[0132] After completing the transfer of the liquid medium, gradually remove the thrust, so that the second telescopic structure expands along the selected direction, and the inner needle 140 is pulled out along the selected direction and returned to the second protective cover. After that, continue to expand the first telescopic structure along the selected direction, so that the outer needle 120 is returned along the selected direction to the first protective cover, and the outer needle 120 is pulled out from the sampling capsule 300.

[0133] During the puncture and withdrawal process of the sampling needle, the inner needle and the outer needle are always isolated from the external environment via the first protective cover, the second protective cover and the sampling capsule 300.

[0134] It can be understood that the inner needle, which ensures sterility, will not come into contact with the air in the internal air chamber of the sampling plug, the outer needle, etc. during the entire sampling process.

[0135] The sterile sampling needle provided by the present invention forms a static sealing structure to the outside world through multiple layers of nested puncture needles and protective sleeves. Compared with the dynamic sealing structure of a direct syringe, there is no risk of cross-zone contamination. When sampling is performed with the sterile sampling needle provided by the present invention, it can be ensured that the inner needle of the innermost layer will not contact the air in the internal air chamber of the sampling plug, the outer needle head, etc., further reducing the risk of contamination during sampling.

[0136] The sterile sampling needle provided by the present invention can transfer liquid media in a closed system in the simplest possible way, and is particularly suitable for small-volume sampling or liquid addition. The sterile sampling method implemented based on the sterile sampling needle can greatly save costs and improve the convenience of sampling or liquid addition.

[0137] The present invention provides a sterile sampling needle having a sterile puncture structure and a fully enclosed sampling needle structure, so that sampling of the device does not require cumbersome cleaning, sterilization, purging or sterile connection structure, and can be directly obtained from the reactor container, which is convenient, fast and sterile. At the same time, after the sampling is completed, the sample is directly sealed, thereby avoiding the risk of sampling container contamination and sample contamination.

[0138] The sampling rubber plug provided by the present invention has a double-layer structure and one or more sterile bag structures, which can be used in conjunction with a sterile sampling needle to further reduce the risk of liquid medium contacting the external environment during sampling. At the same time, multiple sampling can be achieved. The sampling rubber plug in the present invention can be used in disposable sample containers and can also be used in reusable sample containers and replaced.

[0139] The convex structure of the outer plug of a sampling plug provided by the present invention can facilitate identification of the position of the air chamber inside the sampling plug, and at the same time, exhaust air when in contact with the outermost protective cover of the sterile sampling needle, further reducing the risk of contamination during the sampling process.

[0140] The aseptic sampling device provided by the present invention only needs to reserve a sampling plug position in advance for installation, and can directly extract or add liquid from a closed container without any intermediate pipeline, and does not cause waste of liquid medium.

[0141] It should be understood that the above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable people familiar with the technology to understand the content of the present invention and implement it accordingly, and they cannot be used to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the spirit of the present invention should be included in the protection scope of the present invention.

Claims

1. A sterile sampling needle, characterized in that: include: At least two puncture needles and at least two protective sleeves, the at least two puncture needles and at least two protective sleeves are alternately arranged in sequence along the radial direction of the sterile sampling needle, the innermost layer of the sterile sampling needle is the puncture needle, and the outermost layer is the protective sleeve; The protective sleeve has a sealing structure, which is arranged along a selected direction at one end of the puncture end of the puncture needle covered by the protective sleeve. Each puncture needle can move relative to an adjacent protective sleeve along the selected direction under the driving of an external force, and when the puncture needle and an adjacent protective sleeve move relative to each other along the selected direction, the puncture needle can pass through the sealing structure and maintain a sealed state with the sealing structure.

2. The sterile sampling needle according to claim 1, characterized in that: At least two of the puncture needles include an inner needle and an outer needle, and at least two of the protective covers include a first protective cover and a second protective cover, the first protective cover includes a first telescopic structure and a second telescopic structure, both of which can be telescoped along a selected direction, and the first telescopic structure has a first sealing structure that can be pierced by the outer needle; The outer needle, the second protective sleeve and the inner needle are sealed and packaged in the first protective sleeve, the second protective sleeve is arranged between the inner needle and the outer needle, the second puncture end of the inner needle is wrapped by the second protective sleeve, the second protective sleeve is fixedly matched with the outer needle and movably matched with the inner needle, the second protective sleeve also has a second sealing structure through which the inner needle can pass, the outer needle is fixedly connected to the first protective sleeve and movably matched with the first telescopic structure, and the inner needle is also fixedly connected to the second telescopic structure; When the first telescopic structure is telescoped along the selected direction, the outer needle and the first telescopic structure move relative to each other along the selected direction, and the first puncture end of the outer needle can pass through the first sealing structure and extend out of the first protective sleeve; When the second telescopic structure is telescoped along the selected direction, the inner needle and the outer needle move relative to each other along the selected direction, and the second puncture end of the inner needle can pass through the second sealing structure and extend from the outer needle.

3. The sterile sampling needle according to claim 2, characterized in that: The first sealing structure is a flexible structure that can be punctured and can recover its shape when compressed, and when the outer needle passes through the first sealing structure, the first sealing structure and the outer needle maintain a sealed matching state, and when the outer needle is separated from the first sealing structure, the first sealing structure can shrink and maintain its own sealing state; And / or, the first sealing structure is arranged at one end of the first protective sleeve along the selected direction; and / or, the first sealing structure is arranged at one end of the first telescopic structure along the selected direction; And / or, the second sealing structure is a flexible structure that can be punctured and can recover its shape when compressed, and when the inner needle passes through the second sealing structure, the second sealing structure and the inner needle maintain a sealed matching state, and when the inner needle is separated from the second sealing structure, the second sealing structure can shrink and maintain its own sealing state; and / or, the second sealing structure is disposed at one end of the second protective sleeve along the selected direction; and / or, the first telescopic structure and the second telescopic structure are arranged sequentially along the selected direction; And / or, the first protective cover further includes a connecting structure, which is disposed between the first telescopic structure and the second telescopic structure along the selected direction and is fixedly connected to the first telescopic structure and the second telescopic structure; And / or, the connection structure is rigid.

4. The sterile sampling needle according to claim 3, characterized in that: Also includes: An outer needle holding mechanism, wherein the outer needle holding mechanism is fixedly arranged on the outside of the outer needle, the outer needle holding mechanism is movably cooperated with the first telescopic structure, the outer needle holding mechanism can interfere with the first telescopic structure along the selected direction, and form a stop structure with the first telescopic structure to limit the relative movement of the outer needle and the first telescopic structure along the selected direction.

5. The sterile sampling needle according to claim 4, characterized in that: The outer needle comprises a first portion and a second portion sequentially arranged along the selected direction, the first portion is close to the first sealing structure, and the outer needle holding mechanism is arranged on the second portion; And / or, the outer needle holding mechanism is sleeved on the outside of the outer needle; and / or, the outer needle holding mechanism is fixedly connected to the connecting structure; And / or, the outer needle retaining mechanism is integral with the connecting structure.

6. The sterile sampling needle according to claim 1, characterized in that: The second protective cover is fixedly matched with the outer needle, or the second protective cover is movably matched with the outer needle, and the second protective cover is also connected to the second telescopic structure; When the second telescopic structure is extended and retracted along the selected direction, the inner needle and the second protective cover, as well as the second protective cover and the outer needle, all move relative to each other along the selected direction, and the relative movement distance between the inner needle and the second protective cover is greater than the relative movement distance between the second protective cover and the outer needle; And / or, the sterile sampling needle further comprises a needle seat, and the needle seat is fixedly connected to the inner needle and the second telescopic structure; and / or, the selected direction is the axial direction of the sterile sampling needle; And / or, the inside of the first protective sleeve, the outer needle, the second protective sleeve and the inner needle are coaxially arranged.

7. A sampling capsule for use with the sterile sampling needle according to any one of claims 1 to 6, characterized in that: The sampling capsule comprises at least two rubber plugs spaced apart along a selected direction, the at least two rubber plugs are sequentially connected and sealed to form at least one closed air chamber between any two adjacent rubber plugs, the rubber plug is a flexible structure that can be pierced by the puncture needle and can undergo a recoverable deformation when compressed, and when the puncture needle passes through the rubber plug, the rubber plug and the puncture needle maintain a sealed fit state; And / or, a protruding structure is further provided on the side of the outermost rubber plug facing away from the air chamber, and when the protective cover contacts the protruding structure, the protective cover is deformed under pressure and is sealed and fitted with the protruding structure; And / or, the protruding structure is a flexible structure; And / or, a plurality of air chambers isolated from each other are provided between two adjacent rubber plugs, and a plurality of the protruding structures are provided on the rubber plug located on the outermost layer, and the protruding structures correspond to the air chambers one by one.

8. A sterile sampling device, characterized in that: include: A liquid collector and a sterile sampling needle as described in any one of claims 1 to 6, wherein the liquid collector has a liquid collecting chamber, the liquid collecting chamber is connected to the inner needle, and the pressure in the liquid collecting chamber is adjustable.

9. A sterile sampling device, characterized in that: include: A liquid collector and a sterile sampling needle according to any one of claims 1 to 6, wherein the liquid collector has a liquid collecting chamber, the liquid collecting chamber is connected to the inner needle, and the pressure in the liquid collecting chamber is adjustable; Sampling capsules, The invention comprises at least two rubber plugs arranged at intervals along a selected direction, the at least two rubber plugs are sequentially connected and sealed to form at least one closed air chamber between any two adjacent rubber plugs, the rubber plug is a flexible structure that can be pierced by the puncture needle and can undergo a recoverable deformation when compressed, and when the puncture needle passes through the rubber plug, the rubber plug and the puncture needle maintain a sealed matching state; And / or, a protruding structure is further provided on the side of the outermost rubber plug facing away from the air chamber, and when the protective cover contacts the protruding structure, the protective cover is deformed under pressure and is sealed and fitted with the protruding structure; And / or, the protruding structure is a flexible structure; And / or, a plurality of air chambers isolated from each other are provided between two adjacent rubber plugs, and a plurality of the protruding structures are provided on the rubber plug located on the outermost layer, and the protruding structures correspond to the air chambers one by one. And / or, the sterile sampling device further comprises a catheter, and the liquid collector is connected to the innermost inner needle of the sterile sampling needle via the catheter.

10. A sterile sample transfer method, characterized in that include: Providing the sterile sampling device of claim 8; The first sealing structure of the sterile sampling needle is brought into contact with the sample container, and a thrust is applied to the sterile sampling needle along the selected direction, so that the first telescopic structure is contracted along the selected direction, the first sealing structure is sealed and fitted with the sample container, and the outer needle sequentially pierces the first sealing structure and the sample container, and then the second telescopic structure is contracted along the selected direction, the inner needle sequentially pierces the second sealing structure and extends from the outer needle to enter the interior of the sample container; Allow the liquid in the sample container to flow into the liquid collector along the inner needle, or allow the liquid in the liquid collector to flow into the sample container along the inner needle; Gradually removing the thrust, so that the second telescopic structure expands along the selected direction, and the inner needle retreats into the second protective cover along the selected direction; then, expanding the first telescopic structure along the selected direction, and the outer needle retreats into the first protective cover along the selected direction; Alternatively, the aseptic sampling device according to claim 9 is provided, wherein the sampling capsule is arranged on a sample container, the inner rubber plug is arranged inside the sample container, and the outer rubber plug is arranged outside the sample container; The first sealing structure of the sterile sampling needle is brought into contact with the outer rubber plug, and a thrust is applied to the sterile sampling needle along the selected direction, so that the first telescopic structure is contracted along the selected direction, the first sealing structure is sealed and fitted with the outer rubber plug, and the outer needle sequentially pierces the first sealing structure and the outer rubber plug and enters the air chamber, and then the second telescopic structure is contracted along the selected direction, and the inner needle sequentially pierces the second sealing structure and the inner rubber plug and enters the interior of the sample container; Allow the liquid in the sample container to flow into the liquid collector along the inner needle, or allow the liquid in the liquid collector to flow into the sample container along the inner needle; The thrust is gradually removed to expand the second telescopic structure along the selected direction, and the inner needle is retracted into the second protective cover along the selected direction. Then, the first telescopic structure is expanded along the selected direction, and the outer needle is retracted into the first protective cover along the selected direction.

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