Source: http://www.google.com/patents/US20050272169?dq=5359317
Timestamp: 2016-07-25 08:13:22
Document Index: 213178831

Matched Legal Cases: ['art 21', 'art 21', 'art 21', 'art 21', 'art 125', 'arts 121', 'art 101']

Patent US20050272169 - Device for chemical or biochemical analysis - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA device for analysis of a sample, the device comprising: a first layer having a network of passages and chambers through which fluid is caused to flow during analysis; a second layer in which a plurality of chambers are formed, the chambers containing fluids for use in the analysis; an inlet in either...http://www.google.com/patents/US20050272169?utm_source=gb-gplus-sharePatent US20050272169 - Device for chemical or biochemical analysisAdvanced Patent SearchPublication numberUS20050272169 A1Publication typeApplicationApplication numberUS 10/497,854PCT numberPCT/GB2002/005636Publication dateDec 8, 2005Filing dateDec 12, 2002Priority dateDec 13, 2001Also published asDE60209780D1, DE60209780T2, EP1450954A1, EP1450954B1, US7473397, WO2003049860A1Publication number10497854, 497854, PCT/2002/5636, PCT/GB/2/005636, PCT/GB/2/05636, PCT/GB/2002/005636, PCT/GB/2002/05636, PCT/GB2/005636, PCT/GB2/05636, PCT/GB2002/005636, PCT/GB2002/05636, PCT/GB2002005636, PCT/GB200205636, PCT/GB2005636, PCT/GB205636, US 2005/0272169 A1, US 2005/272169 A1, US 20050272169 A1, US 20050272169A1, US 2005272169 A1, US 2005272169A1, US-A1-20050272169, US-A1-2005272169, US2005/0272169A1, US2005/272169A1, US20050272169 A1, US20050272169A1, US2005272169 A1, US2005272169A1InventorsNeil Griffin, Nicki Sutton, Allan Carmichael, Sam Hyde, John SomervilleOriginal AssigneeThe Technology Partnership PlcExport CitationBiBTeX, EndNote, RefManPatent Citations (8), Referenced by (24), Classifications (17), Legal Events (2) External Links: USPTO, USPTO Assignment, EspacenetDevice for chemical or biochemical analysis
DESCRIPTION OF PREFERRED EMBODIMENTS [0084] The testing device 10 shown in FIG. 1 comprises a lower layer 11, an upper layer 12 and an intermediate layer 13. [0085] The lower layer 11 is provided with a network 14 of passages 15 and chambers 16 through which fluids can be caused to flow during use. In particular, the lower layer 11 has a sample chamber 17 into which a sample to be tested can be inserted. The sample chamber 17 may be sized such that it permits only a known, measured volume of the sample to be inserted. A central reaction chamber 18 is in fluid communication with the sample chamber 17 and with a number of the chambers 16 to receive the necessary reagents and sample for the test or tests to take place. A waste reservoir 19 receives reagents once they have passed through the reaction chamber 18. A supply reservoir 20 is in fluid communication with inlet chamber 17 and is used to drive the sample into the reaction chamber 18. The volume of supply reservoir 20 may be such that it limits the amount of the sample which is driven from the inlet chamber 17 into the reaction chamber 18. [0086] The upper layer 12 is comprised, in this example, of a flexible part 21 and a relatively rigid frame 25. In flexible part 21, a number of chamber collectively numbered 22, and individually identified as 30 to 38 inclusive, have been formed. These chambers 22 are located such that they are opposite chambers 16, 20 formed in the lower layer 11 and are constructed such that they are compressible. An inlet opening 23 is formed at one end of the flexible part 21 by a flap means 24 which is movable between a position which allows a sample to be inserted into chamber 17 of the lower layer 11 and a position in which it seals the inlet opening 23. [0087] A relatively rigid frame 25 is the second part of the upper layer 12 and, although shown as an individual component in this example, could be formed integrally with the flexible part 21 and is merely provided to give the upper layer 12 some rigidity. Upper layer 12 could be formed from a single component. The frame 25 is provided with holes corresponding to the locations of the chambers 22, the flap 24 and waste reservoir 19. [0088] The chambers 16 and the reaction chamber 18 can be treated with dry reagents or antibodies or any other required surface treatment to enable the specified reaction to take place. [0089] Chambers 16 and reservoir 20 are provided with projections 26 upstanding from the centre portion of the chamber such that, in use, when the chambers 22 in the upper layer 12 are compressed, thereby pushing the membrane 13 into the respective chamber 16, 20 in the first layer, the projection pierces the membrane 13 to allow fluid from the relevant chamber in the upper layer 12 to flow into the fluid network 14 in the lower layer 11. [0090] Flow control within the device is provided by two means. Firstly, the membrane 13 acts as a seal to prevent liquid reagents passing from the chambers 22 in the upper layer 12 into the fluid network 14 in the lower layer 11. Additionally, the fluids are moved within the fluid network by positive displacement of the chambers 22 in the upper layer 12. The flow rate and the volume of each fluid used are controlled by the rate of compression and the amount of displacement of the chambers 22 respectively. In order to correct for non-linearities in the collapse of materials, capillarity or particular geometries that do not provide a linear volume change with collapse, the compression can be adapted and controlled by a microprocessor (not shown). [0091] The waste reservoir 19 is vented, optionally by means of a non-return valve to protect any reagents in layer 11 from contamination, to correct the pressure differentials within the device and to permit the liquid reagents to flow through the fluid network 14. [0092] As an example test protocol, when analysing human serum for the prostate specific antigen, the reaction chamber 18 is coated with an antibody and the sample chamber is treated with a coagulant. [0093] In this specific example the chambers 22 in the upper layer 12 contain, in individual chambers, zero buffer solution, water rinse, air, enzyme conjugate, tetramethylbenzidine (TMB) solution and hydrochloric acid. [0094] To carry out a test, a sample of whole blood is placed in the sample chamber 17 and sealed closed using the flap means 24. The chamber 17 may be compressed to drive the sample into the reaction chamber 18, or alternatively chamber 30 is then compressed and its contents, which could be air or water, are used to drive the sample into the reaction chamber 18. A filter (not shown) may be used between the sample chamber 17 and reaction chamber 18. In particular this would be useful when testing blood to remove the cells to create plasma. Chamber 31 is then compressed to add zero buffer solution to the reaction chamber 18. Next, chamber 32 is compressed to rinse the reaction chamber 18. Chamber 33 is then compressed to supply air to evacuate the reaction chamber 18 so that the fluids are forced into waste reservoir 19. Chamber 34 is then compressed to add an enzyme conjugate, followed by the compression of chamber 35 which uses water to rinse the reaction chamber 18. Chamber 38 is then compressed to force air into the reaction chamber 18, emptying it into the waste reservoir 19. Chamber 37 is subsequently compressed and TMB solution is added. Chamber 36 is then compressed and hydrochloric acid is added to the reaction chamber. The reaction chamber 18 can then be measured spectrophotometrically at a wavelength of 450 nm. [0095] FIG. 2 shows an alternative arrangement of fluidic network 14 that can be used in the lower layer 11 of the testing device 10 of FIG. 1. The chambers 16 and passages 15 are similar to those of FIG. 1. The chambers 16 for receiving the necessary reagents are arranged such that they are fluid communication with a common pathway 40 which links the inlet chamber 17 and the reaction chamber 18. The reaction chamber 18 is, in this example, a long spiral pathway and this form of reaction chamber can be used when a continuous reaction is to be carried out. The length of the reaction chamber 18 depends upon the length of time required for the reagents to be in contact with any antibody or other chemical provided in the reaction chamber prior to testing. As in the previous example, the reaction chamber 18 empties into a waste reservoir 19. [0096] FIGS. 3 and 4 show an alternative embodiment of the device, where the upper layer 112 containing the compressible chambers consists of a rigid part 125 and flexible parts 121 with several associated piercing pin mechanisms 145. Compression of the chamber 122 by the depression of membranes 121 causes the piercing pin 145 to penetrate the frangible membrane 113 allowing fluid to flow from the upper layer 112 into the lower layer 111. [0097] The lower layer 111 consists of a laminate structure 101, 102. The bottom part 101 of the lower layer 111 consists of a network of fluidic passages 114, mixing elements 117, reaction chambers 118 and waste chambers 119. Layer 102 provides a sealing layer to the lower layer 111. In this embodiment, a sample may be introduced into chamber 131 which can be compressed using sample plunger 130. [0098] In the embodiment in FIGS. 3 and 4, an example ELISA test, and specifically chemi-luminescent test, can be carried out by the insertion of the sample into the sample collection point 131. The sample plunger 130 is then inserted. Compression of the plunger forces the sample from the upper layer 112 into the lower fluidic network layer 111. In this process, the sample as forced through a filter to extract plasma. Chamber 127 is then compressed, thereby forcing the piercing pin 145 through the frangible membrane 113, allowing buffer solution to flow from the upper layer 112 to the lower layer 111. Compressing chamber 127 simultaneously as the sample plunger forces both fluids to flow through a microfluidic mixer element 117. Chamber 123 is then similarly compressed forcing a labelled antibody (antibody 1) solution to mix with the plasma-buffer solution. The antibodies bind to specific proteins in the plasma effectively labelling them. The compression of this chamber forces the mixed fluid to flow into the reaction chambers 118. The reaction chambers 118 are typically coated with a second antibody 2. As the mixed antibody 1—plasma solution flows through the chamber, specific binding of the labelled proteins to antibody 1 on the reaction chamber immobilises the labelled proteins. The residual proteins and unbound antibodies are washed away to waste chamber 119 by the compression of chamber 128 which forces a wash buffer from the upper layer to the lower layer and through the reaction chamber. Having washed the reaction chambers 118, leaving just the bound labelled protein, a chemi-luminescent agent can be flushed through the reaction chambers 118 causing the reaction chambers 118 to luminescence. The quantity of the luminescence is proportional to the bound labelled protein. Typically luminescent agents may include more than one component which require mixing before washing over the bound labelled protein. This is achieved in the embodiment in FIGS. 3 and 4 by including one component in each of chamber 124 and 126. The chambers are compressed simultaneously and the liquids are forced through into the lower layer and through a mixing element where the two components are thoroughly mixed. The continued compression of chambers 124 and 126 forces the mixed chemi-luminescent agent through the reaction chambers 118, causing luminescence of the bound proteins. [0099] The following figures describe different chamber constructions and valves which could be utilised in either of the previously described embodiments. [0100] FIG. 5 shows a first example of a fluid retaining chamber 22 in the upper layer 12. The chamber is provided with a compressible portion 40. A piercing means, in the form of a cone 41 extends from the surface of chamber 16 in the lower layer 11. [0101] In a different example shown in FIG. 6, the chamber 22 is formed within the second layer 12 and is provided with a compressible portion 42. In both examples shown in FIGS. 5 and 6, by actuating the compressible portions 40, 42, the pressure inside the chamber is forced to increase, thereby forcing the frangible layer 13 to depress onto the cone 41, thereby rupturing the frangible seal 13. [0102] FIGS. 7 and 8 show a further example of how a chamber 22 may be formed. In this example, the chamber 22 is formed within the upper layer 12 and is provided with a flexible cover portion 43. A frangible membrane 13 is provided between the upper layer 12 and lower layer 11 such that, when the compressible cover portion 43 is compressed, the increase in pressure within the chamber 22 causes the membrane 13 to rupture, thereby allowing fluid to flow into the network of passages 14 in the lower layer. [0103] In order that the membrane 13 is sufficiently weak that the increase in pressure can rupture it, the film may be provided, as shown in FIG. 9, with a weak portion, in this form a looped portion 44 which is preferably formed by laser ablation. Such a film can be incorporated, as shown in FIG. 10, in the device shown in FIG. 8 and is operated in the same manner. [0104] FIGS. 11 and 12 show a yet further example of how the chambers may be formed. The chamber 22 is, again, formed in the upper layer 12 and a compressible cover portion 43, preferably formed from silicone, covers the upper portion of chamber 22. A chamber 16 is formed in the layer 11 and has a compressible cover portion 43 a, from which a pin 45 projects. Compression of the portion 43 a causes the pin to rupture the layer 13 so that subsequent compression of the portion 43 forces fluid from the chamber 22 into the network of passages in the layer 11. [0105] FIGS. 13 and 14 show a yet further example in which the chamber 22 is formed from a pair of sub-chambers 46, 47. The main sub-chamber 46 contains the desired fluid and the auxiliary sub-chamber retains a pin 45 which, when the compressible silicone cover layer 43 is compressed, pierces the frangible seal 13, thereby allowing fluid from main sub-chamber 46 to flow through passageway 48 into the auxiliary sub-chamber 47 and into the fluid network 14 in the lower layer 11. [0106] FIGS. 15 and 16 show a further example in which the chamber 22 retains a pin 45, in a similar manner to that within the auxiliary sub-chamber 47 of FIGS. 13 and 14, such that depression of the silicone cover layer 43 causes the pin to pierce the frangible seal 13, allowing fluid to flow from the chamber 22 into the fluid network 14 in the lower layer 11. [0107] FIGS. 17 and 18 show a frangible seal 13 onto which a resistive heating element 49 has been printed, preferably by screen printing, such that, in use, the element would be energised for a short time to burn away the film 13, thereby opening the chamber 22 to the fluid network 14 in the lower layer 11. [0108] FIGS. 19 and 20 show perspective views of a further example of a chamber 22, in which a claw 50 is shown, in FIG. 20 in the open position and in FIG. 19 in the closed position, having a hinged portion 51. By moving the claw 50 about the hinge portion 51, it is caused to pierce the frangible seal 13, thereby allowing fluid from chamber 22 to pass into the lower layer 11 (not shown). [0109] FIG. 21 shows chamber 22, recessed in the layer 12, and including a micro syringe 52. The micro syringe 52 includes a slidably mounted piston 53 which can be pushed down using actuator 54 to compress the fluid in the chamber, whilst maintaining a fluid tight seal to the chamber sides. As the volume within the chamber is reduced, the third layer 13 is caused to bow into contact with the piercing means 41, thereby rupturing the third layer and allowing fluid to flow into the network of passages 14 in the first layer 11. [0110] FIGS. 22 and 23 show a top surface valve 60 for a portion of the device in which the upper surface of the device is formed by an elastomeric membrane 61. Fluid is routed from the network 14 in the first layer 11 back into the second layer 12 through a small channel 63 formed between a projection 62 in the first layer, which extend into the second layer, and the membrane 61. Thus, when the elastomeric membrane is compressed as shown in FIG. 22, the passageway 63 between the two portions of the fluidic network 14 is blocked, thereby preventing flow within the network of passages. 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