• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    An aseptic sampling system comprises a sampling assembly and an interface assembly. Each assembly comprises a wrapper, each wrapper defining a separate sterile enclosure for each of the assemblies. An air lock is arranged to provide, in use, the aseptic connection of the sterile enclosures within sampler and interface assemblies, and a resealable liquid connection mechanism is positioned to operate within the air lock. The sampler assembly and interface assembly are arranged so that, when connected together, they form an outer protective surface comprising the casings of each of the sampler and interface assemblies, the outer protective surface providing a sterile inner enclosure and closure. air and an air-tight barrier between the external non-sterile atmosphere and the internal sterile atmosphere. The resealable liquid connection mechanism is contained in the sterile enclosure and contains at least one liquid connector from each of the sampler and interface assemblies and is configured so that, in use, at least one of the liquid connectors can move through sterile enclosure and air lock to connect with the other connector on the liquid connection mechanism, without contacting any internal surfaces on the air lock, and is configured so that the liquid connectors, in use, can subsequently be resealed , disconnected and separated.
    公开号:BR112013020886B1
    申请号:R112013020886-4
    申请日:2012-02-22
    公开日:2020-07-07
    发明作者:Samson Salman Rogers；David Micah Katz；Neil Pollock
    申请人:Pall Europe Limited；
    IPC主号:
    专利说明:

    The present invention relates to an aseptic sampling system. In industries such as medical devices and bioprocessing, there is an identified need for aseptic, ultra-pure removal and injection of multiple samples from a reservoir. The sample and reservoir must not be contaminated by infectious agents that may be present in the atmosphere or on surfaces outside the vessel. The present invention seeks to address the need for a sterile, ultra-clean fluid connection to be made and broken, time after time, without contamination of any sample, any mechanism in the sampler that is in contact with the sample or reservoir , or the liquid in the reservoir itself. The name for this process is ‘aseptic sampling’.
    In the medical industry, for example, in intravenous therapy, clean sampling is currently achieved satisfactorily using a single or dual rubber septum to ensure that minimal dirt is transferred to any samples. A common process is to use a system where a needle is encased in a septum, and when pushed against a second septum, the needle pierces both, creating a fluid path with a very low risk of contamination. However, when the two surfaces of the two septa touch, infectious particles can be dragged between them and transferred to the needle when it punctures and slides through the joint between the two septa. In many processes where a nutrient medium is incubated, a single infectious particle can destroy the product.
    According to the present invention an aseptic sampling system is provided comprising: a sampler assembly and an interface assembly, each assembly comprising a shell, each shell defining a separate sterile enclosure for each of the assemblies; an air lock arranged to provide, in use, an aseptic union of the sterile enclosures within sampler and interface assemblies; and a liquid connection mechanism that can be resealed and positioned to operate within an air lock: the sampling assembly and interface assembly are arranged so that, when connected, they form an outer protective surface comprising the housings of each assembly interface and sampler, the outer protective surface providing a sterile inner enclosure and air seal and an air-tight barrier between the outer non-sterile atmosphere and the inner sterile atmosphere, and where the liquid connection mechanism that can be sealed again it is contained in the sterile enclosure and contains at least one liquid connector from each of the sampler and interface assemblies and is configured so that, in use, at least one of the liquid connectors can move through the sterile enclosure air to connect with the other connector on the liquid connection mechanism, without contacting any internal surfaces on the air seal.
    The system can be arranged so that the liquid connectors, in use, can subsequently be resealed, disconnected and separated.
    This invention provides a sampling medium where both the reservoir and the sample remain free of contaminants that may be present in the atmosphere, or on the surfaces of the sampling device and reservoir, and where many samples can be taken using the same equipment. Furthermore, the invention does not require external means of sterilization, for example, injection of steam or ethylene oxide at high pressure. Rather, the invention can be made from entirely disposable parts.
    Examples of the present invention will now be described with reference to the accompanying drawings, in which:
    Figures 1a and 1b are schematic diagrams showing the principle of the invention;
    Figure 2 shows the external form of the first preferred embodiment of the invention;
    Figures 3a to 3e show the mechanism and operation of the first preferred embodiment of the invention;
    Figures 4a to 4e show the mechanism and operation of the second preferred embodiment of the invention;
    Figure 5 shows a cross-sectional detail of the first preferred embodiment of the invention; and
    Figure 6 further shows descriptions of the first preferred embodiment of the invention.
    The invention is an aseptic sampling system that comprises two fitting assemblies shown schematically in Figure 1a. A sampler assembly 2 whose function is to withdraw or infuse a simple sample, and an interface assembly 1 whose function is to provide the interface between the sampler assembly and the reservoir 38 to be sampled. The interface assembly 1 is usually retained with the reservoir 38 for the duration of an aseptic culture, and allows repeated sampling through the use of one or more units of the sampler assembly 2.
    The sampler and interface assemblies 2, 1 together comprise the following parts. Firstly, an outer protective surface is provided, consisting of an 8.5 casing from each of the interface sampler assemblies 11.6. This external protective surface makes a sterile enclosure by forming a barrier between the external non-sterile atmosphere and an internal sterile atmosphere. Second, an air lock is provided that allows the sterile enclosure to be connected to the sampler and interface assemblies. Thirdly, a resealable liquid connection mechanism is provided which contains a connector on each of the sampler and interface assemblies 2.1. At least one of the connectors is moved through a sterile enclosure and air lock to fit with the opposite connector to the liquid connection mechanism, without sliding over any surfaces that may be non-sterile.
    The liquid connection mechanism, sterile enclosure 18, external protective surface 5.8 and air seal 11.6 are each shown schematically and operated as shown in Figure 1 and described as follows. First, the sampler assembly 2 is fitted with the interface assembly 1 via the air lock 11.6 (Figure 1 bi). The air lock is opened, keeping the sterile enclosure 18 free from outside air contamination. Second, the parts of the liquid connection mechanism 7, 9, 10 are connected within a sterile enclosure, and without sliding beyond surfaces 11.6 of the air seal that may be non-sterile (Figure 1 bii). The liquid connection mechanism 7,9,10 thus creates a sealed aseptic liquid flow path. A sample is then infused or removed from reservoir 38. The sampler and interface assemblies 2.1 are then separated by reversing the above procedure: first the liquid connection mechanism 7,9,10 is again sealed and separated, and then the air lock is disengaged.
    The invention does not depend on particular forms of the component mechanisms. The novelty of this aseptic sampling system is the combination of a liquid connection mechanism that can be resealed with a sterile enclosure 18, protected by an air seal 11.6 and an external protective surface 5.8, so that the connection The liquid connection can be made without the parts of the connection mechanism being exposed to external air or being placed in contact with any surfaces that may be non-sterile, and that the liquid connection can be disconnected without contamination from the sampler or interface assemblies. These properties of the invention are necessary for the utility of the system: taking repeated samples without contamination of sample or reservoir 38, or the use of external sterilization equipment.
    The description below starts with a first realization, but the invention is not limited to the geometry, mechanisms and movements described below.
    The first embodiment, as shown in Fig. 2, comprises two mechanical assemblies, an interface assembly 1 and a sampler assembly 2. The interface assembly provides a connector 3 for a reservoir and the sampler assembly provides a connector 4 for a sample vessel. Figure 2 shows female luer connectors for features 3 and 4. However, alternative embodiments may include barbed pipe fittings, flange sanitary fittings and flange welded seals to connect disposable bag bioreactors or disposable sampling bags.
    Each mechanical assembly comprises separate parts, detailed in the cross-section diagram of Figure 3. Interface 1 comprises a housing 5, plug 6, and liquid valve 7. The connector for the reservoir here is an adaptation of molded tube 3 on the outside of the enclosure 5. The sampler 2 comprises an enclosure protector 8, slider 9, inner cover 10 and outer cover 11.0 shutter 6 is closed in position in the enclosure 5 by an interlock hook 15, which fits into an interlock opening 16.
    The operating mechanism and sequence for the first realization is described with reference to Figures 3a-3e. Figure 3a shows the first run before sampling.
    The first sampling step is shown in Figure 3b, where the sampling assembly 2 is pushed into a slot 12 of the interface assembly 1. The outer cover 11 is then entirely contained in a slot 13 of the plug 6. Simultaneously a protrusion of interlock 14 pushes the interlock hook 15 out of the interlock opening 16. This allows the plug 6 to slide vertically. The engaging faces of the casing 8 and casing 5 protectors form an airproof surface 17.
    The second sampling step is shown in Figure 3c, where the shutter 6 is slid down. This moves the outer cover 11 away from the casing protector 8 which has the effect of joining the sterile atmospheres in the sampler and interface assemblies 2.1 in a single sterile enclosure 18. At this point, the sterile enclosure 18 contains a direct path between inner lid 10 and liquid valve 7, while outer lid 11 is fully stored away from the sterile enclosure 18.
    The third sampling step is shown in Figure 3d. The cursor 9 is now pushed in the direction of interface mounting so that the inner cover 10 engages with the liquid valve 7. The inner cover 10 contains a registration feature 19 that engages with an indentation on the liquid valve 7. A liquid valve 7 and inner cap 10 form a cylindrical, sealable, continuous sliding surface 20 within housing 5.
    The fourth sampling step is shown in Figure 3e. The liquid valve 7 is turned to the open position, so that channel 22 now forms an open path between connector 3 from the reservoir and connector 4 to the sample vessel. The sample then flows through using positive pressure from the reservoir or by applying suction to the sample vessel.
    Having taken the sample, the sampling assembly 2 is then removed. The movements are exactly opposite to the four steps above, leading to the disconnection of sampling assembly 2 as shown in Figure 3a.
    Additional details of the first realization are as follows.
    As shown in the cross-sectional illustration in Figure 5, tab features 23 can be provided over the casing protector 8 for interlocking with slits 24 in the plug 6 so that the casing protector 8 is held against the casing 5 so creating an air seal between the two parts. Figure 6 shows the location of this air seal 17, which also includes an acquiescent material on at least one of the two interlocking surfaces. Similar tongue characteristics can be provided between components shown in Figure 3a: between the outer cover 11 and the casing protector 8 and between the inner cover 10 and the cursor 9.
    The sealing surfaces that are required for the preferred embodiment are shown in Figure 6, and are: the surface 17 between the casing protector 8 and the casing 5; the surface 25 between the casing protector 8 and the cursor 9; the surface 26 between the casing 5 and the plug 6; the surface 27 between the housing 5 and the liquid valve 7; the surface 28 between the housing 5 and the inner cover 10; the surface 29 between the slider 9 and the inner cover 10; the surface 30 between the slider 9 and the liquid valve 7; the surface 31 between the inner lid 10 and the liquid valve 7; and the surface 32 between the casing protector 8 and the outer cover 11.
    All sealing surfaces can be manufactured by incorporating an acquiescent material onto at least one surface in each pair of the parts listed above or by incorporating an additional acquiescent sealing component such as a 0-ring between the mating surfaces of pairs of parts.
    An optional feature that limits the range of movement between the cursor 9 and the enclosure protector 8 is shown in Figure 6. Here a post 33 is connected to the cursor 9 and runs within a groove 34 in the enclosure protector 8. The post 33 ensures that the slider 9 cannot be pulled completely out of the casing protector 8.
    A gas permeable vent 35 that is mounted in housing 5 is also shown in Figure 6. This vent 35 ensures that displacement of air caused by movement of internal parts does not generate a change in air pressure within the sterile enclosure 18 described in Figure 3c . Ventilation 35 also ensures that changes in external air pressure do not generate an air leak between any of the sealing surfaces described above. The ventilation is probably made of a filter material that excludes particles with a diameter greater than 0.22 micrometer.
    A variation on this realization is to use a different liquid connection mechanism so that the liquid valve 7 and the inner cover are replaced with alternative rotary or linear valve mechanisms. Such valves are well known in the art.
    A further variation of this embodiment is a modification of the cursor 6 and housing 5, so that the cursor describes a circular sliding movement rather than a linear sliding movement.
    A second embodiment of the invention is shown in Figures 4a-4e. This realization is consistent with the principle of the invention and the sequence of steps is similar to the first realization. The differences from the first realization are described below.
    As shown in Fig. 4a, the liquid connection mechanism in this case comprises a needle 35 and a pair of septa: a sample septum 36 and an interface septum 37. Interface septum 37 seals interface assembly 1 from the reservoir 38. Figures 4b up to and show the sequence of operations to connect sampler assembly 2 to the contents of reservoir 38. Referring to Figures 4b-4e, the difference in the operational sequence of the first embodiment (Figures 3b-3e) is that the net connection is now made by pushing the cursor 9 directly through the position shown in Figure 4d to the position shown in Figure 4e as shown by the arrow 41. Thus needle 35 pierces both septa, 36 and 37, and enters reservoir 38 so that an aseptic liquid connection is made 39. Removal of the sampler is performed by reversing the sequence of steps in Figures 4b and 4e. The septa 36 and 37 are both made of an elasomeric material that has the ability to reseal the drilled hole after removing the needle. Interface septum 37 is designed to ensure that when needle 35 is removed, interface septum 37 can still maintain both a liquid and air proof seal, even after multiple perforations. A possible embodiment of the sampling vessel is a syringe 40 as shown in Figure 4a.
    权利要求:
    Claims (10)
    [0001]
    1. Aseptic sampling system, CHARACTERIZED by the fact that it comprises: a sampling assembly and an interface assembly, each assembly comprising a wrapper, each wrapper defining a separate sterile enclosure for each of the assemblies; an air lock arranged to provide, in use, the aseptic connection of the sterile enclosures within sampler and interface assemblies; and a liquid connection mechanism that can be resealed positioned to operate within an air lock, where: the sampler assembly and interface assembly are arranged so that, when connected together, they form an outer protective surface comprising the each of the sampler and interface assemblies, the outer protective surface providing a sterile inner enclosure and air seal and an air proof barrier between the non-sterile outer atmosphere and the inner sterile atmosphere, and where the liquid connection mechanism resealable is contained in the sterile enclosure and contains at least one liquid connector from each of the sampler and interface assemblies and is configured so that, in use, at least one of the liquid connectors can move through the enclosure sterile and the air lock to connect with the other connector on the liquid connection mechanism, without contact with any internal surfaces within the air lock.
    [0002]
    2. Aseptic sampling system, according to claim 1, CHARACTERIZED by the fact that the air lock is provided by an external cover in the sampling assembly that fits with a cursor that slides inside a housing in the interface assembly.
    [0003]
    3. Aseptic sampling system, according to claim 2, CHARACTERIZED by the fact that the cursor slides in a linear path.
    [0004]
    4. Aseptic sampling system, according to claim 2, CHARACTERIZED by the fact that the cursor slides in a path of a circle or arc.
    [0005]
    5. Aseptic sampling system, according to any previous claim 1 to 4, CHARACTERIZED by the fact that the liquid connection mechanism is provided by a rotating valve comprising two parts which, when connected, provide a cylindrical sealing surface with at least one internal channel.
    [0006]
    6. Aseptic sampling system according to any one of claims 1 to 4, CHARACTERIZED by the fact that the liquid connection mechanism is provided by a rotary or linear valve that can be resealed.
    [0007]
    7. Aseptic sampling system according to any one of claims 1 to 4, CHARACTERIZED by the fact that the liquid connection mechanism is provided by a deformable septum, a piercing needle and an interface septum.
    [0008]
    8. Aseptic sampling system according to any one of claims 1 to 4, CHARACTERIZED by the fact that the liquid connection mechanism is provided by a piercing needle, a septum and a linear valve.
    [0009]
    9. Aseptic sampling system, according to any previous claim 1 to 8, CHARACTERIZED in that it is arranged so that the separate sterile enclosure within the sampler assembly is no longer provided after the sampler assembly has been removed from the assembly interface.
    [0010]
    10. Aseptic sampling system according to any of the preceding claims 1 to 9, CHARACTERIZED in that it is configured so that the liquid connectors, in use, can subsequently be resealed, disconnected and separated.
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    同族专利:
    公开号 | 公开日
    AU2012221919B2|2014-06-26|
    CN103477201B|2015-06-17|
    JP2014509395A|2014-04-17|
    CN103477201A|2013-12-25|
    EP2678657B1|2019-09-04|
    KR101600571B1|2016-03-04|
    GB201103068D0|2011-04-06|
    US20140345748A1|2014-11-27|
    SG192670A1|2013-09-30|
    JP5760256B2|2015-08-05|
    MX2013009203A|2013-12-06|
    CA2828053A1|2012-08-30|
    US9675520B2|2017-06-13|
    KR20130132975A|2013-12-05|
    AU2012221919A1|2013-08-22|
    WO2012114105A1|2012-08-30|
    BR112013020886A2|2016-09-27|
    RU2013138303A|2015-04-10|
    EP2678657A1|2014-01-01|
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    法律状态:
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-09-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-05-19| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-07-07| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 22/02/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    GB201103068A|GB201103068D0|2011-02-22|2011-02-22|Aseptic sampling system|
    GB1103068.1|2011-02-22|
    PCT/GB2012/050396|WO2012114105A1|2011-02-22|2012-02-22|Aseptic sampling system|
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