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WO2006048678A2 - Sac contenant un reactif - Google Patents

Sac contenant un reactif Download PDF

Info

Publication number
WO2006048678A2
WO2006048678A2 PCT/GB2005/004295 GB2005004295W WO2006048678A2 WO 2006048678 A2 WO2006048678 A2 WO 2006048678A2 GB 2005004295 W GB2005004295 W GB 2005004295W WO 2006048678 A2 WO2006048678 A2 WO 2006048678A2
Authority
WO
WIPO (PCT)
Prior art keywords
bag
diaphragm
pump
inlet
outlet
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/GB2005/004295
Other languages
English (en)
Other versions
WO2006048678A3 (fr
Inventor
Stephen Peter Fitzgerald
John Victor Lamont
Sonya Ferguson
William James Montgomery
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Randox Laboratories Ltd
Original Assignee
Randox Laboratories Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Randox Laboratories Ltd filed Critical Randox Laboratories Ltd
Publication of WO2006048678A2 publication Critical patent/WO2006048678A2/fr
Publication of WO2006048678A3 publication Critical patent/WO2006048678A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1002—Reagent dispensers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/52—Containers specially adapted for storing or dispensing a reagent
    • B01L3/523—Containers specially adapted for storing or dispensing a reagent with means for closing or opening
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B23/00—Pumping installations or systems
    • F04B23/02—Pumping installations or systems having reservoirs
    • F04B23/025—Pumping installations or systems having reservoirs the pump being located directly adjacent the reservoir
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B53/00—Component parts, details or accessories not provided for in, or of interest apart from, groups F04B1/00 - F04B23/00 or F04B39/00 - F04B47/00
    • F04B53/10—Valves; Arrangement of valves
    • F04B53/1037—Flap valves
    • F04B53/1047—Flap valves the valve being formed by one or more flexible elements
    • F04B53/106—Flap valves the valve being formed by one or more flexible elements the valve being a membrane
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B53/00—Component parts, details or accessories not provided for in, or of interest apart from, groups F04B1/00 - F04B23/00 or F04B39/00 - F04B47/00
    • F04B53/10—Valves; Arrangement of valves
    • F04B53/109—Valves; Arrangement of valves inlet and outlet valve forming one unit
    • F04B53/1092—Valves; Arrangement of valves inlet and outlet valve forming one unit and one single element forming both the inlet and outlet closure member
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/141—Preventing contamination, tampering
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/12—Specific details about materials
    • B01L2300/123—Flexible; Elastomeric
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0478—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure pistons
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/505—Containers for the purpose of retaining a material to be analysed, e.g. test tubes flexible containers not provided for above
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0439—Rotary sample carriers, i.e. carousels
    • G01N2035/0443—Rotary sample carriers, i.e. carousels for reagents

Definitions

  • the invention relates to a reagent holding bag, for example for use in a chemical or biochemical assays and the like.
  • the established method for the storage of chemical reagents as required for use on medical diagnostic machines is a plastic bottle.
  • Such containers are used for multi- test or bulk storage and come in a variety of shapes and sizes. They are typically located in a rotary carousel to enable a relatively simple method of location and delivery for aspiration of the contents via automated pipetting. A typical example is shown in WO-A-98/00236.
  • WO-A-02/058845 discloses an alternative approach in which a reaction vessel is provided, which is preferably disposable, having a number of upper holding chambers for containing chemicals needed for the process. A plug selectively opens and seals the upper inlet of each chamber, each chamber having a lower outlet. The problem with this system is that it is relatively complex and therefore costly to manufacture.
  • a reagent holding bag comprises an at least partially, preferably fully, collapsable wall defining a reagent reservoir, the wall having an outlet to which is secured a pump for delivering a measured dose of reagent without permitting air ingress into the bag, at least part of the wall of the bag being adapted to collapse as the dose is delivered.
  • This invention solves a number of the problems set out above. Firstly, by providing each bag with its own pump, a self-contained package is provided and this can be disposed of after use without the need for washing of pump and tubing etc.
  • the costly components within a pump assembly are typically those components providing a displacement force/energy.
  • the pump mechanics are assembled with the bag structure as a disposable unit leaving the high value pump drive component external and inherently isolated from the fluid path.
  • Typical increases in shelf life are from the conventional 8/12 weeks up to 1 or 2 years, while typical volumes may be in the range 100ml to 300ml.
  • an at least partially collapsable wall reduces the likelihood of bubbles entrained within the dispensed fluid or reagent.
  • the collapsible wall enables the bag volume to reduce simultaneously as reagent is dispensed. If the reagent bag did not contract, then air/gas would normally be allowed to enter to offset the volume of reagent dispensed. Allowing the bag wall to collapse eliminates the requirement for gas/air to enter and thereby reduces the likelihood of bubbles becoming entrained within the dispensed fluid or reagent.
  • the pump and valve should also be of a design which prevents air/gas and potentially bubbles being dispensed with the fluid/reagent.
  • a semi-rigid support or skeletal framework may be provided to loosely constrain the bag. This could assist in packing during transit, efficient storage on board an analyser, elimination/ reduction in "folding/flopping over" during use which might cause difficulties in fluid removal.
  • the support or framework When the bag is full or partially full, the support or framework maintains the bag usually in a largely upright position above the pump enabling fluid/reagent to be accessed by the pump.
  • the bag Preferably, the bag should be able to collapse completely thereby minimizing the amount of non-accessible fluid/dead volume. In practice, this may not be possible and will depend on the design and the extent to which the bag walls can "fold together" while the bag is being emptied.
  • the bag could be emptied whilst in a horizontal position with respect to the pump or if positioned below the pump.
  • the pump would need to overcome the effects of the weight of fluid acting downwards on the bag walls.
  • One section of the semi-rigid support or skeletal framework may comprise the disposable elements of the pump.
  • the pump could be indirectly connected to the outlet via a tube.
  • the wall will typically be made of one or more plastics materials which are flexible so as to provide the collapsable property.
  • the wall is formed as a laminate having at least a first layer adjacent the reagent and chosen so as not to react with the reagent, and a second layer for preventing contaminant ingress therethrough.
  • Typical contaminants which are inhibited by the second layer include UV and/or oxygen and possibly also visual wavelengths, other gases, water (vapour) or other fluids.
  • the second layer can comprise a metallised layer or paper, depending upon the potential contaminants.
  • the first layer will typically be a plastics material such as polyethylene or polypropylene.
  • a third, outer layer such as a plastics, for example nylon, is provided physically to protect the inner layers. Additional layers may also be provided if required.
  • Preferred layer combinations comprise nylon/foil/ paper/polyethylene and nylon/metallized polyester/ polyethylene. The laminate is preferably heat sealed around its edge although it could be bonded or otherwise secured.
  • reagents which may be provided in the bag include assay buffer, diluent, and signal generating e.g. chemiluminescent reagents.
  • the invention also relates to a reagent dispensing system comprising a plurality of bags according to the first aspect of the invention the bags being mounted on a carousel which is operable to deliver a selected bag to a dispense location.
  • the pump can have a conventional form but we have devised a new pump assembly in accordance with a second aspect of the present invention comprising a main pump chamber coupled with an inlet and an outlet, and means for varying the volume of the main chamber, the volume varying means being operable in a first direction to increase the volume of the main chamber such that liquid is drawn in use into the main chamber through the inlet, and in an opposite, second direction to decrease the volume of the main chamber so that liquid in the main chamber is dispensed through the outlet; and a diaphragm extending across the inlet and outlet wherein: a) the diaphragm seals against a first closure member of the pump assembly, in response to the volume varying means moving in the first direction, so as to prevent the passage of liquid into the main chamber from the outlet while permitting liquid to pass into the
  • This new pump assembly has a particularly simple construction with a single diaphragm which is operable in response to movement of the volume varying means to control the flow of liquid between the inlet and outlet. This is also useful since this pump assembly can be constructed relatively cheaply and therefore can form a disposable unit with the rest of the bag, as explained above.
  • volume varying means could be defined by a collapsible part of the main chamber wall, preferably the volume varying means comprises a piston. This makes the volume varying means easily controllable.
  • the volume varying means is preferably normally urged in the first direction, for example by a compression spring or other resilient member.
  • the inlet, outlet and diaphragm can be arranged in a number of different ways as will be explained in more detail below.
  • the diaphragm includes at least one aperture so that liquid can pass from one side of the diaphragm to the other.
  • the closure members preferably have a dome-shaped form to enhance the sealing action with the diaphragm while the diaphragm is conveniently stretched across the closure members.
  • Figure 1 is a perspective view of an example of a bag according to the invention
  • Figure 2 is a schematic, partial cross-section on a line A-A in Figure 1
  • Figure 3 is a view similar to Figure 1 but with the pump assembly exploded;
  • Figure 4 is a cross-section through the pump assembly and part of the bag shown in Figure 1;
  • Figure 5 is a further exploded view of the pump assembly;
  • Figure 6 is a perspective view of a dispensing carousel carrying a plurality of bags similar to that shown in Figure 1;
  • Figure 7 is a perspective view of a second example of a bag according to the invention.
  • Figure 8 is a cross-section through the pump assembly of Figure 7.
  • the bag 1 shown in Figures 1 to 5 comprises a reagent reservoir 2 located between a pair of heat sealed laminate walls 3,4.
  • each wall 3,4 comprises a polyethylene inner layer 5, a metalised, plastics layer 6 for inhibiting the ingress of contaminants such as UV light or oxygen and a plastics outer layer 7.
  • the material of the inner layer 5 is chosen such that it does not react with the reagent to be stored within the reservoir 2.
  • the two walls 3,4 are heat sealed together around an edge 8.
  • a plastics cylinder 9 is heat sealed between the two walls 3,4.
  • the cylinder 9 is integrally moulded with a plastics pump assembly base 10 having an opening 11 communicating via a conduit 14 with the interior of the reservoir 2 and opening through a domed section 16 of the base 10.
  • the base 10 also defines an outlet chamber 18.
  • An elastomeric diaphragm 20 is secured over the base 10 and a plastics pump housing 22 is mounted to the base 10.
  • the diaphragm 20 extends across an inlet chamber 24 formed in the housing 22 and aligned with an aperture 26 in the diaphragm 20.
  • An inlet conduit 28 extends from the base of the inlet chamber 24 into a main chamber 30 of the pump.
  • the inlet chamber 24 is surrounded by a raised rim 66 which seals against the diaphragm 20 irrespective of the distortion of the diaphragm.
  • An outlet conduit 32 extends from the main chamber 30 to the outlet chamber 18.
  • the outlet of the conduit 38 is separated from the outlet chamber 18 by the diaphragm 20.
  • a domed rim 40 surrounds the exit of the outlet conduit 38 and contacts the diaphragm 20.
  • the domed rim 40 forms a first closure member while the domed section 16 forms a second closure member.
  • a reciprocal piston member or plunger 46 is slidably received in a guide conduit 48 of the pump housing 22 and is biassed towards its retracted position (not shown) by a compression spring 50.
  • Examples of other pumps which could be implemented include diaphragm and syringe pumps.
  • the pump is arranged to dispense a lOO ⁇ l dose whenever the piston 40 is fully depressed.
  • a bag 1 which can contain up to say 200 or 300ml, this allows more than one dose to be stored.
  • FIG. 6 illustrates schematically a reagent dispensing system comprising an endless belt 80 driven by a motor (not shown) and on which a large number of bags 1 of the type shown in Figures 1 to 5 are mounted.
  • Each bag 1 is supported on the belt 80 so that it can be moved laterally away from the belt as shown by bag IA in Figure 6 through an exit aperture 82 of a refrigerated container 84 in which the carousel is located.
  • the assay system to which the carousel is mounted includes a bag transit mechanism 86.
  • the belt 20 is rotated to bring a required bag 1 adjacent the opening 82.
  • the bag transit mechanism 86 is then actuated to withdraw the selected bag 1 from the store 84 and move it to a dispense location 88. At this point, the bag is brought in alignment with a reaction cuvette 90 in which an assay is to be performed. This may include a conventional chemical analyser or contain a biochip on which the assay is to be performed. This can be done by any known mechanism.
  • a pump actuator 92 is then activated to depress the piston 46 causing the required reagent dose to be dispensed from the bag IA into the cuvette 90.
  • FIG. 7 A second example of a bag and pump assembly is shown in Figures 7 and 8.
  • the bag 1 has a similar construction to that shown in Figures 1 to 5 and will not be further described.
  • This bag 1 is attached to a pump assembly 100 which has a different construction to that shown in Figures 1 to 5.
  • the pump assembly 100 is shown in more detail in Figure 8.
  • the assembly comprises a pump housing 102 integrally formed with the conduit 14 extending into the bag 1, the conduit 14 opening into an upper section 104 of a main chamber 106 of the pump assembly.
  • An outlet conduit 108 extends through the pump housing 102 and opens into a lower section 110 of the main chamber 106.
  • a diaphragm 112 is stretched across the main chamber 106 and contacts a first closure member defined by a domed section 114 surrounding the outlet conduit 108.
  • the diaphragm 112 has an aperture 116 which is located in alignment with a second, domed closure member 118 integrally formed with a wall of the housing 102.
  • a piston 120 is mounted for reciprocal movement in a guide conduit 122.
  • the diaphragm 112 When the piston or plunger 120 is moved towards the main chamber 106 (to the right in Figure 8) , the diaphragm 112 is compressed under fluid pressure against the second closure member 118 thereby preventing liquid from passing into the upper section 104 of the chamber. However, the fluid pressure causes the diaphragm 112 to distort upwardly and thereby open access to the outlet conduit 108 so that fluid can flow out through the outlet conduit.
  • This pump assembly can be actuated by a similar mechanism to that shown in Figure 6.
  • This second pump assembly has some advantages over the first in that it is more compact and uses less parts and so will be cheaper to manufacture and thus more readily disposable.
  • bag shape has been shown in the drawings, other shapes could be used such as a concertina form with folding sides which compress as liquid is removed. This would reduce the need for an outer supporting framework. In this example, the pump assembly would then be bonded to a flat face rather than two sides of the bag.
  • the outlet conduit may be shaped or positioned to allow liquid dispense in any direction with respect to the pump assembly. It should also be understood that the bag/pump assembly can be used in reverse, for example to hold waste or sample fluids in various applications. In other words, the reservoir would be coupled with the outlet conduit rather than the inlet conduit.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

L'invention concerne un sac (1) contenant un réactif qui comprend une paroi (3, 4) pouvant au moins partiellement s'affaisser qui définit un réservoir de réactif (2). Ladite paroi comprend une sortie (11) à laquelle est fixée une pompe destinée à distribuer une dose de réactif mesurée sans permettre l'entrée d'air dans ledit sac. Au moins une partie de la paroi du sac (1) est conçue pour s'affaisser à mesure que la dose est distribuée.
PCT/GB2005/004295 2004-11-08 2005-11-07 Sac contenant un reactif Ceased WO2006048678A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0424660.9 2004-11-08
GB0424660A GB0424660D0 (en) 2004-11-08 2004-11-08 Reagent holding bag

Publications (2)

Publication Number Publication Date
WO2006048678A2 true WO2006048678A2 (fr) 2006-05-11
WO2006048678A3 WO2006048678A3 (fr) 2006-12-21

Family

ID=33523360

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2005/004295 Ceased WO2006048678A2 (fr) 2004-11-08 2005-11-07 Sac contenant un reactif

Country Status (2)

Country Link
GB (1) GB0424660D0 (fr)
WO (1) WO2006048678A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9075033B2 (en) * 2008-01-07 2015-07-07 Roche Diagnostics Operations, Inc. Reagent cartridge
JP2016532880A (ja) * 2013-10-08 2016-10-20 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ 自動分析器を使用して試料中の分析物の測定を実施するための方法

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114013834B (zh) * 2021-07-07 2023-05-12 福宁虹昇科技(杭州)有限公司 一种自动化转运托盘

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI71102C (fi) * 1982-02-25 1986-11-24 Fluilogic Systems Oy Reagensfoerpackning
US4646781A (en) * 1985-05-07 1987-03-03 Pacesetter Infusion, Ltd. Diaphragm valve for medication infusion pump
JPH0786509B2 (ja) * 1985-06-18 1995-09-20 株式会社東芝 自動化学分析装置
FR2689014B1 (fr) * 1992-03-24 1994-06-03 Aguettant Lab Pompe de perfusion de liquides medicaux.
US6092695A (en) * 1992-05-11 2000-07-25 Cytologix Corporation Interchangeable liquid dispensing cartridge pump
DE4446170A1 (de) * 1994-12-23 1996-06-27 Bosch Gmbh Robert Sperrventilanordnung für eine Pumpvorrichtung
JP3998770B2 (ja) * 1997-09-05 2007-10-31 大日本印刷株式会社 分配装置
US6494694B2 (en) * 2001-04-25 2002-12-17 Abbott Laboratories Disposable infusion cassette with low air bubble retention and improved valves

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9075033B2 (en) * 2008-01-07 2015-07-07 Roche Diagnostics Operations, Inc. Reagent cartridge
JP2016532880A (ja) * 2013-10-08 2016-10-20 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ 自動分析器を使用して試料中の分析物の測定を実施するための方法
US10241124B2 (en) 2013-10-08 2019-03-26 Roche Diagnostics Operations, Inc. Method to perform a measurement of an analyte in a sample using an automatic analyzer

Also Published As

Publication number Publication date
WO2006048678A3 (fr) 2006-12-21
GB0424660D0 (en) 2004-12-08

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