Aseptic sampling device and method of use thereof

Abstract

The present invention provides a sterile sampling device and a method for using the same. The sterile sampling device includes a pre-set pipe fitting, a fixing component, and a puncture assembly. The pre-set pipe fitting is pre-connected to the pipeline system of the material to be sampled, and the sampling port of the pre-set pipe fitting is externally connected to the fixing component with a piston structure; the fixing component includes a sealed fixing cavity and a fixing member penetrating into the fixing cavity. The fixing cavity is communicated with the pre-set pipe fitting through the sampling port. A limiting portion is provided on the fixing member, and the limiting portion is used to limit the one-way movement of the fixing member; the puncture assembly includes a puncture member for blocking the sampling port of the pre-set pipe fitting and a puncture needle combined with the fixing member. During the one-way advancement of the fixing member, the puncture needle is driven to move along the puncture direction, and the puncture needle pierces through the puncture member and inserts into the pre-set pipe fitting to collect the material to be sampled flowing in the pre-set pipe fitting. The present invention realizes the internal sealing of the sampling device, effectively avoiding environmental pollution from the outside during the sampling process and the leakage of pathogens in the cell culture medium.

Description

Technical Field

[0001] The present invention belongs to the technical field of sampling devices, and relates to a sterile sampling device and a method for using the same, and particularly relates to a small sterile sampling device and a method for using the same. Background Art

[0002] During the cell culture process under fully enclosed conditions, it is necessary to regularly sample and conduct quality inspection on the cell culture medium. On the one hand, it is necessary to strictly consider the aseptic requirements for the cell culture medium during the sampling process, and it is not allowed for external pathogens to enter the cell culture environment. On the other hand, it is also necessary to consider the impact of the viruses that may exist in the cell culture medium itself on the operator and the external environment.

[0003] CN108998365A discloses a sterile rapid detection device and a rapid detection method, that is, on a tank body, a hollow tube column extending into the tank body is integrally formed with the tank body; at the bottom of the tube column, a sampling needle with an elastic plug at the top is provided; above the sampling needle, a vacuum sampling tube with a rubber stopper plugged and an opening downward is preset. After the rapid detection device is sterilized aseptically, in a fully enclosed aseptic environment, the object to be detected is injected into the tank body and a culture medium is injected, filtered, enriched, and cultured. After several hours, the vacuum sampling tube is pressed downward forcefully, the sampling needle penetrates through the rubber plug at its top and the rubber stopper at the bottom of the vacuum sampling tube, and extends into the vacuum sampling tube, and the liquid to be detected is sucked into the vacuum sampling tube through the sampling needle. After the sampling is completed, the vacuum sampling tube is pulled out, and the elastic plug at the top of the sampling needle synchronously restores its elasticity with the pulled-out vacuum sampling tube, blocking the sampling needle to ensure that the original liquid in the tank body is not contaminated; then, the extracted sample is subjected to rapid RNA detection.

[0004] CN110129186A discloses a cell culture sterile sampling device, including an incubator. Inside the incubator, multiple groups of sampling units are evenly distributed at intervals from left to right. The heights of the multiple groups of sampling units in the incubator increase from left to right in sequence. Each group of sampling units includes a circular tube. There are multiple groups of channels on the circular tube. Each group of channels includes multiple first through grooves. There is a fixed tube outside the circular tube. Multiple second through grooves corresponding to the first through grooves one by one are provided on the fixed tube. The front end of each circular tube has an elbow. A needle head is provided at the inner end of the elbow. A rubber disk capable of blocking it is provided inside the circular tube. A turntable is fixed at the rear end of the circular tube. A first through hole is provided on the outer circumferential surface of the turntable. A sleeve is installed outside the turntable. Four second through holes are evenly distributed in the circumferential direction on the sleeve. The four second through holes are connected clockwise to a high-pressure gas source, a disinfection water source, a clear water source, and a cell nutrient solution source.

[0005] CN103477201A discloses a sterile sampling system, comprising: a sampler assembly and an interface assembly, each assembly including a housing which defines a separate sterile chamber for each assembly; an air lock which is arranged to provide a sterile connection between the sterile chambers within the sampler assembly and within the interface assembly in use; and a resealable liquid connection mechanism which is positioned to operate within the air lock, wherein: the sampler assembly and the interface assembly are arranged such that when they are connected together they form an external protective surface which includes the respective housings of the sampler assembly and the interface assembly, the external protective surface providing a sterile inner cavity and air lock and an airtight barrier between the external non-sterile atmosphere and the internal sterile atmosphere, and wherein the resealable liquid connection mechanism is housed within the sterile chamber and includes at least one liquid connector from both the sampler assembly and the interface assembly, and the resealable liquid connection mechanism is configured such that in use at least one liquid connector can move through the sterile chamber and the air lock to connect with another connector within the liquid connection mechanism without contacting any inner surface within the air lock.

[0006] However, the existing sampling system equipment has a complex structure, cumbersome operation, and poor flexibility, and is not suitable for a cell culture system that requires regular sampling and detection. Therefore, for the cell culture medium that requires regular sampling and quality inspection, a small sampling device needs to be designed. Summary of the Invention

[0007] Aiming at the deficiencies of the existing technology, the purpose of the present invention is to provide a sterile sampling device and its use method. The sterile sampling device provided by the present invention, as a fully enclosed cell culture consumable, is mainly used for sample collection in a cell culture system and regularly samples and inspects the quality of the cell culture medium. By setting a limiting part, a one-time sampling operation is realized. During the entire sampling process, the internal sealing of the sampling device is achieved, effectively avoiding environmental pollution from the outside during the sampling process and the leakage of pathogens in the cell culture medium. At the same time, the sterile sampling device provided by the present invention is small in size, convenient to operate, and has a low production cost.

[0008] To achieve this purpose, the present invention adopts the following technical solutions:

[0009] In the first aspect, the present invention provides a sterile sampling device, which includes a pre-set pipe fitting, a fixing component, and a puncturing component. The pre-set pipe fitting is pre-connected to the pipeline system of the material to be sampled, and the sampling port of the pre-set pipe fitting is externally connected to the fixing component of the piston structure.

[0010] The fixing component includes a sealed fixing cavity and a fixing piece penetrating into the fixing cavity. The fixing cavity is communicated with the pre-set pipe fitting through the sampling port. A limiting part is provided on the fixing piece, and the limiting part is used to limit the one-way movement of the fixing piece.

[0011] The described puncture assembly includes a puncture piece for blocking the sampling port of a pre - installed pipe fitting and a puncture needle combined with the fixing piece. During the one - way advancement of the fixing piece, the puncture needle is driven to move along the puncture direction. The puncture needle pierces through the puncture piece and inserts into the pre - installed pipe fitting to collect the material to be sampled flowing inside the pre - installed pipe fitting.

[0012] The sterile sampling device provided by the present invention, as a consumable for biological sampling, is more compact in equipment volume, lower in production cost, and more convenient to operate compared with the existing sampling systems. It is especially suitable for the regular sampling and quality inspection of cell culture media. Due to the above characteristics, the sterile sampling device provided by the present invention can be set at any position in the pipeline system of the material to be sampled, and the installation quantity can also be adjusted according to the number of samplings. Compared with the large - scale sampling equipment with complex structures disclosed in the prior art, its mobility, flexibility, and operability all show obvious advantages.

[0013] In terms of the device structure, the one - time sampling operation is realized by setting the limiting part. During the entire sampling process, the internal sealing of the sampling device is achieved, effectively avoiding the environmental pollution from the outside during the sampling process and the leakage of pathogens in the cell culture medium.

[0014] It should be noted that the sampling device provided by the present invention needs to be pre - installed in the pipeline system of the cell culture medium. Before installation, the whole sampling device needs to be sterilized. In addition, since the sampling device provided by the present invention is a one - time consumable, multiple groups of sampling devices need to be connected in parallel in the pipeline system of the cell culture medium according to the number of samplings, and the device becomes invalid after sampling.

[0015] As a preferred technical solution of the present invention, the fixed cavity includes a fixed housing with one end open and a fixed cover plate for sealing the open end of the fixed housing. The fixed housing is communicated with the pre - installed pipe fitting through the sampling port, and the fixed cover plate covers the open end of the fixed housing to make the inside of the fixed housing sealed;

[0016] Preferably, a through - hole for the fixing piece to penetrate is opened on the fixed cover plate, and the fixing piece extends into the inside of the fixed housing after passing through the through - hole on the fixed cover plate.

[0017] As a preferred technical solution of the present invention, the fixing piece includes a fixed seat and a fixed rod. The fixed seat is located inside the fixed housing, and the fixed rod extends into the inside of the fixed housing after passing through the through - hole on the fixed cover plate and is connected to the fixed seat.

[0018] Preferably, a limiting part is provided on the fixed rod, and the limiting part cooperates with the through - hole on the fixed cover plate to limit the one - way movement of the fixed rod.

[0019] Preferably, the limiting part is barbs arranged on the outer peripheral surface of the fixed rod.

[0020] Preferably, an exhaust hole is formed in the fixed seat. During the one-way advancement of the fixed rod, the air compressed by the fixed seat is discharged through the exhaust hole.

[0021] Preferably, a filter membrane is provided at the exhaust hole.

[0022] In the present invention, during the advancement of the fixed rod, since the fixed seat needs to compress the internal air of the fixed cavity, in order to avoid the obstruction of pressure causing the fixed rod to be unable to advance normally, an exhaust hole needs to be provided to discharge the air compressed by the fixed seat; in addition, in order to ensure the clean environment inside the fixed cavity, a filter membrane is provided at the exhaust hole to filter the air flowing through the exhaust hole to avoid cross-contamination.

[0023] As a preferred technical solution of the present invention, an annular sealing ring is provided between the fixed seat and the fixed housing.

[0024] As a preferred technical solution of the present invention, the puncture needle sequentially penetrates through the fixed rod and the fixed seat along the puncture direction and extends out of the fixed seat. During the one-way advancement of the fixed rod, the puncture needle gradually pierces into the puncture member until it pierces through the puncture member and extends into the internal of the pre-placed pipe fitting.

[0025] As a preferred technical solution of the present invention, the puncture member is a puncture rubber.

[0026] As a preferred technical solution of the present invention, the sterile sampling device further includes a sampling assembly, and the sampling assembly includes a sampling hose connected to the puncture needle and an inner needle provided at the outlet end of the sampling hose.

[0027] Preferably, a clamping member is provided on the sampling hose. After sampling is completed, the sampling hose is locked by the clamping member to prevent the material to be sampled from continuously flowing out.

[0028] Preferably, the clamping member is a clamping plate or a clip.

[0029] As a preferred technical solution of the present invention, the sampling assembly further includes a protection member sleeved outside the inner needle.

[0030] Preferably, the protection member is a rubber sleeve.

[0031] In a second aspect, the present invention provides a method for using the sterile sampling device as described in the first aspect, and the method for using includes:

[0032] Push the fixing member. Under the one-way limiting action of the limiting portion, the fixing member drives the puncture needle to move unidirectionally along the puncture direction. The puncture needle pierces through the puncture member and inserts into the pre-placed pipe fitting to collect the material to be sampled flowing inside the pre-placed pipe fitting.

[0033] As a preferred technical solution of the present invention, the usage method specifically includes the following steps:

[0034] (Ⅰ) Push the fixed rod. The barb structure limiting part on the fixed rod cooperates with the through hole on the fixed cover plate to realize the one-way movement of the fixed rod along the puncture direction. The fixed rod drives the puncture needle to penetrate the puncture rubber until it is inserted into the internal part of the preset pipe fitting.

[0035] (Ⅱ) Squeeze the rubber sleeve. After the embedded needle pierces the rubber sleeve, it pricks into the sampling container. Under the negative pressure in the sampling container, the material to be sampled flowing in the preset pipe fitting flows through the puncture needle and the sampling hose in sequence and then flows out through the embedded needle into the sampling container to complete the sampling.

[0036] (Ⅲ) After sampling, clamp the clamping plate to block the flow of the material to be sampled in the sampling hose, and fuse the sampling hose to complete the collection of the material to be sampled. However, it is not limited to the listed values, and other unlisted values within this value range are equally applicable.

[0037] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0038] (1) The sterile sampling device provided by the present invention, as a consumable for biological sampling, is smaller in equipment volume, lower in production cost, and more convenient to operate compared with the existing sampling systems, and is particularly suitable for the regular sampling and quality inspection of cell culture media.

[0039] (2) The present invention realizes the one-time sampling operation of the sampling device by setting the limiting part. During the whole sampling process, the internal sealing of the sampling device is realized, effectively avoiding the environmental pollution from the outside during the sampling process and the leakage of pathogens in the cell culture medium.

[0040] (3) The sterile sampling device provided by the present invention can be set at any position in the pipeline system of the material to be sampled, and the number of devices can also be adjusted according to the number of sampling times. Compared with the large and complex-structured sampling equipment disclosed in the prior art, its mobility, flexibility and operability all show obvious advantages. Description of the Drawings

[0041] Figure 1 It is a schematic structural diagram of the sterile sampling device provided by a specific embodiment of the present invention.

[0042] Among them, 100 - preset pipe fitting; 200 - fixing component; 210 - fixing cavity; 211 - fixing housing; 212 - fixing cover plate; 220 - fixing part; 221 - fixing seat; 222 - fixing rod; 223 - filter membrane; 224 - limiting part; 230 - annular sealing ring; 300 - puncture component; 310 - puncture part; 320 - puncture needle; 400 - sampling component; 410 - sampling hose; 420 - clamping part; 430 - embedded needle; 440 - protection part. Detailed implementation mode

[0043] It should be understood that in the description of the present invention, the orientation or positional relationship indicated by the terms "center", "longitudinal", "transverse", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present invention.

[0044] It should be noted that in the description of the present invention, unless otherwise clearly specified and limited, the terms "set", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood through specific situations.

[0045] The technical solution of the present invention will be further described below in conjunction with the drawings and through specific implementation modes.

[0046] In a specific implementation mode, the present invention provides a sterile sampling device. The sterile sampling device is as shown in Figure 1 and includes a pre-set pipe fitting 100, a fixing component 200, and a puncture component 300. The pre-set pipe fitting 100 is pre-connected to the pipeline system of the material to be sampled, and the sampling port of the pre-set pipe fitting 100 is externally connected to the fixing component 200 with a piston structure.

[0047] The fixing component 200 includes a sealed fixing cavity 210 and a fixing member 220 penetrating into the fixing cavity 210. The fixing cavity 210 is communicated with the pre-set pipe fitting 100 through the sampling port. A limiting portion 224 is provided on the fixing member 220, and the limiting portion 224 is used to limit the one-way movement of the fixing member 220.

[0048] The fixing cavity 210 includes a fixing housing 211 with one end open and a fixing cover plate 212 for sealing the open end of the fixing housing 211. The fixing housing 211 is communicated with the pre-set pipe fitting 100 through the sampling port. The fixing cover plate 212 covers the open end of the fixing housing 211 to make the inside of the fixing housing 211 sealed. A through hole for the fixing member 220 to penetrate is provided on the fixing cover plate 212, and the fixing member 220 extends into the inside of the fixing housing 211 after passing through the through hole on the fixing cover plate 212.

[0049] The fixing member 220 includes a fixing base 221 and a fixing rod 222. The fixing base 221 is located inside the fixing housing 211. The fixing rod 222 passes through the through hole on the fixing cover plate 212 and extends into the fixing housing 211 and is connected to the fixing base 221. A limiting portion 224 is provided on the fixing rod 222. The limiting portion 224 cooperates with the through hole on the fixing cover plate 212 to limit the one-way movement of the fixing rod 222. Further, the limiting portion 224 is barbs provided on the outer peripheral surface of the fixing rod 222. An exhaust hole is provided on the fixing base 221. During the one-way advancement of the fixing rod 222, the air squeezed by the fixing base 221 is discharged through the exhaust hole. A filter membrane 223 is provided at the exhaust hole. An annular sealing ring 230 is provided between the fixing base 221 and the fixing housing 211. The puncture needle 320 sequentially penetrates through the fixing rod 222 and the fixing base 221 along the puncture direction and extends out of the fixing base 221. During the one-way advancement of the fixing rod 222, the puncture needle 320 gradually pierces into the puncture member 310 until it pierces through the puncture member 310 and extends into the preset pipe fitting 100.

[0050] The puncture assembly 300 includes a puncture member 310 for blocking the sampling port of the preset pipe fitting 100 and a puncture needle 320 combined with the fixing member 220. During the one-way advancement of the fixing member 220, the fixing member 220 drives the puncture needle 320 to move along the puncture direction. The puncture needle 320 pierces through the puncture member 310 and inserts into the preset pipe fitting 100 to collect the material to be sampled flowing in the preset pipe fitting 100. Further, the puncture member 310 is a puncture rubber.

[0051] The sterile sampling device further includes a sampling assembly 400. The sampling assembly 400 includes a sampling hose 410 connected to the puncture needle 320 and an inner needle 430 provided at the outlet end of the sampling hose 410. A clamping member 420 is provided on the sampling hose 410. After sampling is completed, the sampling hose 410 is locked by the clamping member 420 to prevent the material to be sampled from continuously flowing out. Further, the clamping member 420 is a clamping plate or a clip. The sampling assembly 400 further includes a protective member 440 sleeved outside the inner needle 430. Further, the protective member 440 is a rubber sleeve.

[0052] It should be noted that the sampling device provided in this specific embodiment needs to be pre-installed in the pipeline system of the cell culture medium. Before installation, the sampling device also needs to be sterilized as a whole. In addition, since the sampling device provided in this specific embodiment is a disposable consumable, multiple groups of sampling devices need to be connected in parallel in the pipeline system of the cell culture medium according to the number of samplings. The device becomes invalid after sampling is completed.

[0053] In another specific embodiment, the present invention provides an operation process for sampling using the above sterile sampling device, which specifically includes the following steps:

[0054] (Ⅰ) Push the fixed rod 222. The barb structure limiting part 224 on the fixed rod 222 cooperates with the through hole on the fixed cover plate 212 to realize the one-way movement of the fixed rod 222 along the puncture direction. The fixed rod 222 drives the puncture needle 320 to pierce the puncture rubber until it is inserted into the internal part of the preset pipe fitting 100;

[0055] (Ⅱ) Squeeze the rubber sleeve. After the embedded needle 430 pierces the rubber sleeve, it pricks into the sampling container. Under the negative pressure in the sampling container, the material to be sampled flowing in the preset pipe fitting 100 flows through the puncture needle 320 and the sampling hose 410 in sequence and then flows out through the embedded needle 430 into the sampling container to complete the sampling;

[0056] (Ⅲ) After the sampling is completed, clamp the clamping plate to block the flow of the material to be sampled in the sampling hose 410, and fuse the sampling hose 410 to complete the collection work of the material to be sampled.

[0057] The applicant declares that the above description is only the specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily thought of by any person skilled in the art within the technical scope disclosed by the present invention fall within the protection scope and the disclosure scope of the present invention.

Claims

1. A sterile sampling device, characterized in that, The described sterile sampling device includes a pre - installed pipe fitting (100), a fixing component (200), and a puncture assembly (300). The pre - installed pipe fitting (100) is pre - connected to the pipeline system of the material to be sampled, and the sampling port of the pre - installed pipe fitting (100) is externally connected to the fixing component (200) with a piston structure; The fixing component (200) includes a sealed fixing cavity (210) and a fixing member (220) penetrating into the fixing cavity (210). The fixing cavity (210) is communicated with the pre - installed pipe fitting (100) through the sampling port. A limiting portion (224) is provided on the fixing member (220), and the limiting portion (224) is used to limit the one - way movement of the fixing member (220); The fixing cavity (210) includes a fixing housing (211) with one end open and a fixing cover plate (212) for sealing the open end of the fixing housing (211). The fixing housing (211) is communicated with the pre - installed pipe fitting (100) through the sampling port. The fixing cover plate (212) covers the open end of the fixing housing (211) to make the inside of the fixing housing (211) sealed; A through - hole for the fixing member (220) to penetrate is provided on the fixing cover plate (212), and the fixing member (220) penetrates through the through - hole on the fixing cover plate (212) and then extends into the inside of the fixing housing (211); The fixing member (220) includes a fixing seat (221) and a fixing rod (222). The fixing seat (221) is located inside the fixing housing (211), and the fixing rod (222) penetrates through the through - hole on the fixing cover plate (212) and then extends into the inside of the fixing housing (211) and is connected to the fixing seat (221); A limiting portion (224) is provided on the fixing rod (222), and the limiting portion (224) cooperates with the through - hole on the fixing cover plate (212) to limit the one - way movement of the fixing rod (222); The limiting portion (224) is barbs provided on the outer peripheral surface of the fixing rod (222); An exhaust hole is provided on the fixing seat (221). During the one - way advancement of the fixing rod (222), the air compressed by the fixing seat (221) is discharged through the exhaust hole; A filter membrane (223) is provided at the exhaust hole; The puncture assembly (300) includes a puncture member (310) for blocking the sampling port of the pre - installed pipe fitting (100) and a puncture needle (320) combined with the fixing member (220). During the one - way advancement of the fixing member (220), the puncture needle (320) is driven to move along the puncture direction. The puncture needle (320) pierces the puncture member (310) and inserts into the pre - installed pipe fitting (100) to collect the material to be sampled flowing in the pre - installed pipe fitting (100); The sterile sampling device further includes a sampling assembly (400). The sampling assembly (400) includes a sampling hose (410) connected to the puncture needle (320) and an inner - embedded needle (430) provided at the outlet end of the sampling hose (410); A clamping member (420) is provided on the sampling hose (410). After sampling is completed, the sampling hose (410) is locked by the clamping member (420) to prevent the material to be sampled from continuously flowing out.

2. The aseptic sampling device according to claim 1, wherein, An annular sealing ring (230) is provided between the fixed seat (221) and the fixed housing (211).

3. The aseptic sampling device according to claim 1, characterized in that, The puncture needle (320) sequentially penetrates through the fixed rod (222) and the fixed seat (221) along the puncture direction and extends out of the fixed seat (221). During the one-way advancement of the fixed rod (222), the puncture needle (320) gradually pierces into the puncture member (310) until it pierces the puncture member (310) and extends into the internal part of the pre-set pipe fitting (100).

4. The aseptic sampling device according to claim 1, wherein The puncture member (310) is a puncture rubber.

5. The aseptic sampling device according to claim 4, characterized in that, The clamping member (420) is a clamping plate or a clip.

6. The aseptic sampling device according to claim 5, wherein, The sampling assembly (400) further includes a protective member (440) sleeved outside the inner needle (430).

7. The aseptic sampling device according to claim 6, wherein The protective member (440) is a rubber sleeve.

8. A method for using the aseptic sampling device according to any one of claims 1-7, characterized in that, The usage method includes: Push the fixing member (220). Under the one-way limiting action of the limiting portion (224), the fixing member (220) drives the puncture needle (320) to move unidirectionally along the puncture direction. The puncture needle (320) pierces the puncture member (310) and inserts into the pre-set pipe fitting (100) to collect the material to be sampled flowing in the pre-set pipe fitting (100).

9. The usage method according to claim 8, wherein The specific usage method includes the following steps: (I) Push the fixed rod (222). The barbed structure limiting portion (224) on the fixed rod (222) cooperates with the through hole on the fixed cover plate (212) to realize the unidirectional movement of the fixed rod (222) along the puncture direction. The fixed rod (222) drives the puncture needle (320) to pierce into the puncture rubber until it inserts into the internal part of the pre-set pipe fitting (100). (II) Squeeze the rubber sleeve. After the inner needle (430) pierces the rubber sleeve, it pierces into the sampling container. Under the negative pressure in the sampling container, the material to be sampled flowing in the pre-set pipe fitting (100) sequentially flows through the puncture needle (320) and the sampling hose (410) and then flows out from the inner needle (430) into the sampling container to complete the sampling. (III) After sampling is completed, the clamping plate blocks the flow of the material to be sampled in the sampling hose (410), and the sampling hose (410) is melted to complete the collection work of the material to be sampled.

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