WO2007057744A2 - Reference croisee a des demandes connexes - Google Patents

Reference croisee a des demandes connexes Download PDF

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Publication number
WO2007057744A2
WO2007057744A2 PCT/IB2006/003206 IB2006003206W WO2007057744A2 WO 2007057744 A2 WO2007057744 A2 WO 2007057744A2 IB 2006003206 W IB2006003206 W IB 2006003206W WO 2007057744 A2 WO2007057744 A2 WO 2007057744A2
Authority
WO
WIPO (PCT)
Prior art keywords
marker
fluid
reservoir
fluid reservoir
activator
Prior art date
Application number
PCT/IB2006/003206
Other languages
English (en)
Other versions
WO2007057744A3 (fr
WO2007057744A8 (fr
Inventor
Satwinder Singh Panesar
Colin Hanna
David Kinniburgh Lang
Andrew Gill
Claus Marquordt
Original Assignee
Inverness Medical Switzerland Gmbh
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 Inverness Medical Switzerland Gmbh filed Critical Inverness Medical Switzerland Gmbh
Publication of WO2007057744A2 publication Critical patent/WO2007057744A2/fr
Publication of WO2007057744A8 publication Critical patent/WO2007057744A8/fr
Publication of WO2007057744A3 publication Critical patent/WO2007057744A3/fr

Links

Classifications

    • 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
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502715—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
    • 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
    • B01L2200/16—Reagents, handling or storing thereof
    • 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
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0672—Integrated piercing tool
    • 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
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0816—Cards, e.g. flat sample carriers usually with flow in two horizontal directions
    • 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
    • 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
    • B01L2400/0481—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure squeezing of channels or chambers
    • 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
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0677—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
    • B01L2400/0683—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber

Definitions

  • This invention relates to a fluid reservoir for storage of small amounts of liquid and methods of removal of the liquid stored in a fluid reservoir to a device.
  • a patient with a health problem such as pre-heart failure or heart failure can be managed in the home or a non-hospital setting.
  • a means is provided to detect or monitor the patient's condition.
  • a device allows the patient to perform frequent measurements of one or more analytes.
  • a device for in home use should require little or no training and provide accurate results. Only a small volume of sample, detection reagents, or buffers is required.
  • the device can include a test cartridge or multiple test cartridges and a test cartridge reader. The device can be used to assay a variety of analytes.
  • the test cartridge can be prepared to detect one or more of a variety of analytes.
  • the user can select a test cartridge that is sensitive to the desired analyte, and obtain a measurement of that analyte with the device.
  • the user can then slide the test cartridge into the reader when required to perform an assay.
  • the reader instrument can operate with a high degree of automation in order to reduce the possibility of user error.
  • Partially or fully automated features of the system include control of sample volume; detection of a test cartridge; and location detection of the test cartridge (i.e., whether test cartridge is correctly inserted, fully or partially inserted). Detection of a successful assay run is made by detection of fluid at the end of the flow path. Timing of fluid flow through different regions of the flow path can be controlled.
  • a device for detecting an analyte includes a microfluidic channel configured to accept a sample fluid and including a detection zone, a sealed fluid reservoir arranged to release fluid to the microfluidic channel when activated, and a fluid activator arranged to apply a force to the fluid reservoir and thereby activate the fluid reservoir.
  • the fluid activator can include an indentor, a slider or a piston.
  • the sealed fluid reservoir can be a liquid pouch.
  • the sealed fluid reservoir can contain sample, detection agent, reagents, wash buffer, diluting agent or rehydrating buffer.
  • the sealed fluid reservoir can be connected to the microfluidic channel by a connecting channel.
  • the sealed fluid reservoir and the connecting channel can have a 2:1 aspect ratio, or a 3:1 aspect ratio, with respect to the area of the reservoir and the cross-sectional area of the channel.
  • the fluid activator can include an indentor.
  • the indentor can be a spring loaded indentor.
  • the spring loaded indentor can include a ball.
  • the fluid activator can be a slider.
  • the slider can include a piercer to puncture the sealed fluid reservoir.
  • the piercer can be a needle.
  • the fluid activator can be a piston.
  • the device can include a plurality of piston stops.
  • the device can include a hinged support region configured to support the sealed fluid reservoir.
  • the sealed fluid reservoir can be a blister pouch.
  • the hinged support region can close toward the connecting channel.
  • the fluid activator can include a recess including a piercer.
  • the piercer can be the tip of a hollow needle.
  • the bore of the hollow needle can be fluidly connected to the microfluidic channel.
  • the needle can have a lancet tip.
  • the sealed fluid reservoir can be a blister pouch.
  • the blister pouch can include a compressible spacer configured to space the blister pouch a distance from the piercer while the compressible spacer is in an uncompressed state.
  • the detection zone can be configured to measure a level of a marker present in a sample fluid, wherein the marker is a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, or a marker of sodium retention.
  • the marker is a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, or a marker of sodium retention.
  • a system for monitoring cardiac health includes a test cartridge including a microfiuidic channel configured to accept a sample fluid and including a detection zone, a sealed fluid reservoir arranged to release fluid to the microfiuidic channel when activated, and a fluid activator arranged to apply a force to the fluid reservoir and thereby activate the fluid reservoir, a detector configured to measure a level of a marker present in a sample fluid, where the marker is a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, or a marker of sodium retention.
  • a method of releasing a fluid stored in a sealed fluid reservoir includes applying force via a fluid activator to the reservoir wherein applying force via a fluid activator includes actuating an indentor, a slider, a piston, or a piercer.
  • the method can include releasing a sample, a detection agent, a reagent, a wash buffer, a diluting agent, or a rehydrating buffer from the fluid reservoir.
  • Applying force via a fluid activator to the reservoir can include moving the reservoir relative to the fluid activator.
  • the fluid activator can include a piercer to puncture the sealed fluid reservoir.
  • the piercer can be the tip of a hollow needle.
  • the needle can have a lancet tip.
  • the sealed fluid reservoir can be a blister pouch.
  • the blister pouch can include a compressible spacer configured to space the blister pouch a distance from the piercer while the compressible spacer is in an uncompressed state. Applying force via a fluid activator to the reservoir can include compressing the compressible spacer.
  • FIG. IA-B are schematic drawings depicting a device with a sealed fluid reservoir and an indentor to rupture a sealed fluid reservoir.
  • FIG. IC-D are schematic drawings depicting a device with a fixed indentor and a test cartridge containing a sealed fluid reservoir.
  • FIG. IE-F are schematic drawings depicting a device with a spring loaded indentor and a test cartridge containing a sealed fluid reservoir.
  • FIG. 2A-B are schematic drawings depicting a device utilizing a slider to rupture a sealed fluid reservoir.
  • FIG. 2 A is a top view of the device.
  • FIG. 2B is a side view of the device.
  • FIG. 3A-B are schematic drawings depicting a side view of a device utilizing a piston to rupture a sealed fluid reservoir.
  • FIG. 4A-B are schematic drawings depicting a side view of a device utilizing a lock-in cavity method to rupture a sealed fluid reservoir.
  • FIG. 5 is a schematic drawing depicting a device with an indentation and a piercing member at the base of the indentation to rupture a sealed fluid reservoir.
  • FIGS. 6A-6B are schematic drawings depicting an adapter and a fluid reservoir.
  • FIGS. 7A-7B are schematic drawings depicting an adapter and a fluid reservoir with a compressible spacer.
  • FIG. 7C are illustrations of different piercing member designs.
  • FIG. 8 is a diagram illustrating a system including a diagnostic device and an associated test cartridge.
  • DETAILED DESCRIPTION Tasks such as metering discrete fluid volumes and combining those volumes are relatively straightforward when working with fluids in conventional macrofluidic volumes.
  • Planar immunoassay formats typically require a wash step to separate free antibody from analyte-bound antibody prior to making a measurement of conjugated enzymatic or fluorescent labels.
  • Implementation of such an assay format in a disposable test cartridge may require a controlled means to supply a wash buffer and perform a wash step.
  • Other applications in which fluidic metering accuracy is important include microfluidic applications where it would be desirable to combine consistent accurate and discrete fluid volumes. For example, it may be desirable to provide stoichiometric microfluidic volumes of reagents, wash buffer, sample or diluent.
  • a device for detecting an analyte includes a sealed fluid reservoir adapted to release fluid upon application of force wherein the force is applied via a fluid activator, a connecting channel fluidly connected to the reservoir and liquid cavity, a resuspension zone fluidly connected to the connecting channel, and a detection zone fluidly connected to the resuspension zone.
  • the sealed fluid reservoir can be a separate liquid pouch that can be integrated into the test cartridge.
  • the fluid reservoir can be sealed by a membrane, a film or any other material that will rupture upon application of an external force or pressure.
  • the fluid reservoir can be in a blister format wherein the fluid is sealed by a membrane or a film which ruptures upon application of an external force or pressure.
  • the external force can be applied via fluid activator situated within the device.
  • the fluid activator may include an indentor, a slider or a piston.
  • the sealed fluid reservoir, such as a blister may have a weak point which ruptures on application offeree.
  • a sealed fluid reservoir can be provided as part of a test cartridge that is used to perform a diagnostic measurement using a sample of blood, interstitial fluid, saliva, urine, or the like.
  • the fluid reservoir may contain reagents, or buffers to hydrate dry state reagents or buffers to dilute a sample of blood, interstitial fluid, urine or buffers to act as a wash/motive force to move sample through various reaction chambers.
  • the fluid contained within a fluid reservoir may be used to hydrate dry state reagents or to dilute a sample applied to the test cartridge or to wash a measurement zone prior to recording a measurement value.
  • the sealed fluid reservoir may be integrated into a test cartridge.
  • a user may apply pressure to the fluid reservoir at the point of conducting a test measurement, either before or after application of a sample such as a capillary blood sample.
  • the fluid reservoir may be designed to rupture at a defined location, thus delivering the contained fluid in a controlled manner through the test cartridge into the reader device.
  • the fluid may flow through the test cartridge at a constant flow rate.
  • the fluid may also be directed to flow through the connecting channel to a resuspension zone at a predefined flow rate for a predetermined period of time according to the parameters of a particular test.
  • a microstructured flow path can include capillary structures.
  • fluid flow along the flow path can be driven and controlled by capillary forces.
  • Fluid flow can also be driven and controlled by mechanical and shear forces over short distances.
  • the microstructured flow path can be defined, for example, by a depression or depressed region, or by elevations forming walls that can contain a liquid.
  • the flow path can be defined by an elevated region surrounded by a depressed region, for example, a moat.
  • the fluid may also be directed to flow through the connecting channel to a microfluidic cavity.
  • the microfluidic cavity can be configured to collect a predetermined volume of liquid. The cavity can ensure that a sufficient volume of sample or buffer is introduced to the device for the device to work as intended. See for example, U.S Provisional Application 60/665,868, herein incorporated by reference in its entirety.
  • the fluid reservoir 10 can be integrated into a test cartridge 20.
  • An elastic deformable region 30 is provided on at least one external surface of the test cartridge.
  • the fluid reservoir 10 may be caused to rupture and thereby deliver the fluid contents by application of an external force.
  • a force is applied to elastic deformable region 30, the fluid 50 within the reservoir 10 is compressed.
  • the increased pressure of the fluid causes an inner wall 40 of the fluid chamber, which may be non-elastic, to break (see FIG. IB).
  • Fluid 50 may be released from the reservoir into connecting channel 60. Released fluid may be delivered via for example, one or more microchannels from the test cartridge to one or more predetermined locations within the device.
  • the released fluid may be a constant flow or may be an instantaneous or may be a slow continuous flow.
  • Slow continuous flow may be achieved by the relationship between the externally applied force and the geometry of the fluid outlet from the reservoir.
  • Slow continuous flow may also be achieved by the configuration of a microchannel array based upon the dimension of the channels or the hydrophobic/hydrophilic nature of the channels to control the draw of fluid through the channel.
  • external force may be applied by a finger.
  • a receptacle within a device may be configured to receive the test cartridge containing a sealed fluid reservoir. When the test cartridge is pressed into the receptacle, a fluid activator that includes an indenting feature engages with and deforms the elastic deformable region causing rupture of an inner wall of the fluid reservoir, thereby releasing fluid.
  • the receptacle within a test device can include a well.
  • the well may be positioned vertically or horizontally within the test device.
  • the integrated indenting feature may be provided on a resilient spring that expands downwardly to ensure that a constant pressure is maintained on the fluid reservoir.
  • a test cartridge 20 containing a sealed fluid reservoir 10 can be inserted into device 70 with a fixed indentor 80.
  • the indentor 80 causes the compression of the fluid 50 within the reservoir 10.
  • the increased pressure of the fluid causes an inner wall 40 of the fluid chamber, which may be non-elastic, to break (see FIG. ID). Fluid 50 may be released from the reservoir into connecting channel 60.
  • the sealed fluid reservoir may be ruptured by application of a force via a fluid activator such as an indentor.
  • the indentor may include a spring loaded indentor such as a ball.
  • a test cartridge 20 containing a sealed fluid reservoir 10 can be inserted into device 70 with a spring loaded indentor 90. As test cartridge 20 is pressed into device 70, the spring loaded indenter 90 moves upward and spring is compressed. Referring to FIG. IF, when indentor 90 lies over sealed fluid reservoir 30, the spring 91 extends and causes the compression of the fluid 50 within the reservoir 10. Referring to FIG.
  • the increased pressure of the fluid causes an inner wall 40 of the fluid chamber, which may be non-elastic, to break. Fluid 50 may be released from the reservoir into connecting channel 60. As the spring 91 continues to decompress more, fluid 50 is forced from fluid reservoir. As fluid is forced from the reservoir, the spring can continue to apply pressure to ensure that a constant back pressure is maintained.
  • the elastic deformable region may be provided with an area profile that is significantly greater than the burstable portion such that the force applied externally may be greatly amplified and thus increase the likelihood that reliable bursting may be achieved every time.
  • the flow of the liquid contained within a fluid reservoir may be controlled by adjusting the aspect ratio between the area of the reservoir and the cross sectional area of the connecting channel. For example, referring to FIG. IB, the aspect ratio between the area of the sealed fluid reservoir 50 and the cross sectional area of the connecting channel 60 may be 2:1, 3:1 or 4:1.
  • a fluid reservoir is provided as part of a test cartridge 110.
  • the sealed fluid reservoir 100 maybe inserted into a receptacle of a test cartridge or it may be integrated into the test cartridge.
  • the test cartridge 110 may be inserted into a receptacle of a test device that is used to conduct a measurement.
  • the receptacle of the test device may further be provided with a fluid activator 120.
  • a fluid activator can include a plunger or a slider.
  • the slider 120 can include a piercer to puncture the sealed fluid reservoir and the piercer may be for example, a hollow needle 130. The slider can be moved into the sealed fluid reservoir whereupon the piercer 130 that is linked to the slider punctures the sealed fluid reservoir 100.
  • a piercer forms a hole in an outer membrane of the fluid reservoir.
  • a fluid activator for example a piston, compresses the fluid reservoir. Compressed fluid is forced through the fluid activator into the body of the test cartridge or through a connecting channel.
  • the fluid can be a sample, detection agent, reagents, wash buffer, diluting agent or rehydrating buffer. The fluid can flow through a resuspension zone prior to entering the detection zone.
  • an integrated fluid reservoir 200 can be provided as part of a test cartridge.
  • a fluid activator such as piston 210 may be provided, either as an integral feature or as a separate feature of the test cartridge.
  • a user may compress piston into the test cartridge. The action of pressing piston into the test cartridge causes rupture of membrane used to contain fluid as illustrated in FIG. 3B. Fluid is thereby discharged into the assay area 220. Alternatively, fluid may be discharged into a resuspension zone via connecting channels prior to entering the detection zone.
  • the positioning of a piston can provide the means to control the volume of fluid dispensed as a function of time.
  • a test may be configured which requires addition of fluid in discrete volumes at discrete times.
  • an integrated fluid reservoir is provided in a blister format 300.
  • the blister may be presented on a rigid support base 310 that may be provided as an independent portion or as a hinged portion on a test cartridge.
  • a test cartridge 320 may be configured to receive the blister.
  • the fluid blister forms a liquid tight seal with test cartridge as illustrated in FIG. 4B.
  • a fluid activator such as a piercer 330 within the blister receiving portion of the test cartridge ruptures the blister and displaces fluid 340 from the blister.
  • a blister containing portion may be hingedly attached to a test cartridge.
  • the hinge may be provided such that upon insertion of test cartridge into test device, the hinge enters the receptacle and thereby the hinged portion is forced closed.
  • the test cartridge may have a thickness that is substantially similar to the opening of the receptacle. Therefore the test cartridge is made to fit with an interferent fit within the receptacle. " The support for the fluid blister is thus pressed sufficiently tightly against the base of test cartridge to form a liquid tight seal thereby preventing loss of liquid from fluid blister following rupture of blister by burst means.
  • the drawing shows a portion of test cartridge 400 with an indentation 440.
  • An integrally formed piercer 410 is provided within the base of the indentation 440.
  • the piercing member 2 further includes a capillary channel 420 through which fluid may flow, driven by capillary force alone, or by an externally applied motive force.
  • a sealed fluid reservoir 430 is provided that fits within the indentation 440 of test cartridge 400. Fluid reservoir 430 has at its base an inward protrusion shaped to prevent contact of the fluid reservoir 430 with piercer 410 when no external positive force or internal negative force is present.
  • fluid reservoir 430 When an externally applied positive pressure or internally applied negative pressure is applied to fluid reservoir 430, the inward protrusion of the reservoir is forced onto piercing member 410, which causes fluid reservoir 430 to rupture and thereby release the fluid contained therein.
  • the fluid released from reservoir 430 is drawn through capillary channel 420 for delivery to a desired location within a test cartridge, for example, wherein an assay may be performed.
  • the opening within piercer 410 is shaped such that when reservoir 430 is either pushed or pulled into contact with piercer 410, the material from which reservoir 430 is formed does not fragment and enter capillary channel 420.
  • capillary channel 420 may remain open to allow free passage of fluid from reservoir 430 to the predetermined regions within test cartridge 400 of which the fluid reservoir 430 is an integral part.
  • Capillary channel 420 is fluidly connected to one or more regions within test cartridge 400 within which measurement reactions may occur.
  • adapter 500 includes piercing member 502 located in recess 504.
  • Adapter 500 also includes channel 506, which is fluidly connected to recess 504.
  • Channel 506 also extends through neck 508.
  • Neck 508 can be adapted to fit (e.g., in a liquid-tight manner) in a corresponding collar in a cartridge, so as to deliver liquid from recess 504 to a test cartridge.
  • Piercing member 502 can have a generally conical shape.
  • Channel 506 can extend through member 502, and channel 502 can be located off-axis with respect to the generally conical shape of member 502.
  • Locating channel 506 off-axis of conical piercing member 502 can provide a tip 510 that extends farther into recess 504 than does the mouth 512 of channel 506. hi some circumstances, an edge of channel 506 is located at tip 510. Locating channel 506 off-axis of conical piercing member 502 can help prevent "coring", or blocking of channel 506 by solid material when member 502 ruptures a fluid reservoir.
  • piercing member can be an integral feature of adapter 500, i.e., member 502 is molded.
  • adapter 500 is molded with channel 506 but lacking a piercing member.
  • Piercing member is then added separately to complete adapter 500. This allows piercing member to be made of a different material than the rest of the adapter.
  • piercing member 502 can be metal, such as a stainless steel (e.g. a stainless steel needle, such as a hypodermic needle, or a portion thereof), while the rest of adapter 500 is an injection molded plastic.
  • the piercing member 502 can protrude above the floor 528 at the pointed end.
  • the internal bevel portion of piercing member 502 can lie beneath the floor 528, in channel 506, such that there is an unrestricted path for fluid to flow out of recess 504 into channel 506.
  • Adapter 500 can be used in conjunction with fluid reservoir 514, illustrated in FIG. 6B.
  • Reservoir 514 includes backing 516 and blister 518.
  • Backing 516 can blister 518 are sealed together (i.e., a liquid-tight seal) at edges 520 to enclose fluid 522.
  • Blister 518 can include ridge 524 and valley 526.
  • Ridge 524 and floor 528 of adapter 500 can have complementary shapes.
  • ridge 524 and floor 528 can have the same radius of curvature.
  • the complementary shapes of ridge 524 and floor 528 can ensure that ridge and floor come into contact (e.g., close contact) when reservoir 514 is contacted to adapter 500.
  • the complementary shapes of ridge 524 and floor 528 can also be chosen so as to promote transfer of fluid from reservoir 514 to channel 506.
  • the shape of floor 528 can be such that channel 506 is at a low point in floor 528, and floor 528 can be substantially free of any local low points that could potentially trap fluid.
  • the complementary shapes can be configured to align valley 526 with piercing member 502.
  • Valley 526 can contact piercing member 502. When a force is applied to bring reservoir and adapter together, piercing member 502 can penetrate blister 518 at valley 526.
  • valley 526 includes a weak point that ruptures reliably when a force is applied to it.
  • reservoir 514 further includes a compressible spacer 530, for example at an edge 520 of reservoir 514.
  • Spacer 530 in its uncompressed state, allows reservoir 514 to contact adapter 500 at a distance sufficient to ensure that piercing member 502 does not pierce blister 518.
  • spacer 530 can be compressed (e.g., by applying a compressive force to backing 516).
  • Spacer 530 allows reservoir 514 to be assembled with adapter 500 (e.g., during manufacturing of a test cartridge), while restricting premature rupture of blister 518 (e.g., during manufacture, shipment, or other handling before fluid delivery is desired).
  • Spacer 530 can determine the distance between blister 518 and piercing member 502.
  • Spacer 530 can be, for example, a foam spacer (e.g., a foam ring around blister 518), or a compressible gasket.
  • a compressible spacer can be located on adapter 500 in a position that will contact edges 520 of reservoir 514 when adapter 500 and reservoir 514 are assembled.
  • FIG. 7C illustrates three different needle types that were tested as piercing members.
  • Needle tips can have, for example, a bevel tip (e.g., as is formed by a single bevel cut) or a lancet tip (e.g., as is formed by a primary bevel cut and one or more secondary bevel cuts).
  • Type A had a 40 degree angle on the lancet point of the needle tip
  • types B and C had 60 degree angles on the lancet point of the needle tips. These can also be referred to as the angle of rotation of a lancet point.
  • the horizontal line through the needle tip in FIG. 7C indicates the portion of the needle tip that protruded above the floor 528 into recess 504 of adapter 500. As illustrated in FIG.
  • the full length of a bevel or lancet tip need not protrude from channel 506 into recess 504.
  • the needle has a lancet tip.
  • the lancet tip (or a portion of the lancet tip) can protrude into recess 504, while the bevel portion of the tip and the shaft of the needle are positioned in channel 506.
  • the portion of the needle which protruded above the base floor can represent less that 20% of the circumference of the needle.
  • the height of the needle protruding above floor 528 can be less than 3 mm, less than 2mm, or less than 1 mm. hi some cases, the height of the needle protruding above floor 528 can be between 0.5 and 1.0 mm.
  • the needle diameter can be between 0.5 mm and 3 mm, for example, 1 mm.
  • the device can be provided with a cap that prevents premature rupture of blister 518, e.g., during manufacture, storage, transport, or at any time before such rupture is desired (such as during an assay).
  • the cap can be configured such that the height of the cap is greater than the height of the device and reservoir together. In this way, when the cap is in place, it can prevent the blister from contacting the piercing member.
  • the cap can be rigid or frangible.
  • the cap is removed (e.g., by a user of the device) prior to use of the device.
  • the cap remains in place and is disrupted before or at the time of use so that the reservoir can be ruptured at a desired time.
  • the cap can be a rigid cap configured to prevent compression of a compressible spacer while the cap is in place, by enforcing a minimum distance between the reservoir and the piercing member. When the cap is removed, so is the restriction on compression of the compressible spacer. The blister can then be moved into contact with the piercing member to burst the blister.
  • test cartridges and devices described herein can be included in a diagnostic kit, which can optionally include one or more of the following: instructions for using the kit for event detection, diagnosis, prognosis, screening, therapeutic monitoring or any combination of these applications for the management of patients with pre-heart failure, heart failure, or hypertension; a disposable test cartridge containing the necessary reagents to conduct a test; or an instrument or device that measures the result of biomarker testing and optionally, allows manual or automatic input of other parameters, storage of said parameters, and evaluation of said parameters alongside or separate from the evaluation of the measured biomarkers.
  • test cartridge or cartridges supplied in the kit allows the user to measure or to monitor for example, a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, or a marker of sodium retention.
  • the test cartridge or test cartridges allow the sequential or serial measurement of a marker of inflammation, a marker of plaque instability and/or a marker of plaque rupture.
  • the test cartridge or test cartridges allow the sequential or serial measurement of analytes such as a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, or a marker of sodium retention.
  • a combination cartridge can test two or more different markers from a single sample.
  • the instrument durable or disposable
  • diagnostic device 600 includes display 620 and input region 640.
  • the display 620 may be used to display images in various formats, for example, joint photographic experts group (JPEG) format, tagged image file format (TIFF), graphics interchange format (GIF), or bitmap.
  • Display 620 can also be used to display text messages, help messages, instructions, queries, test results, and various information to patients.
  • display 620 supports the hypertext markup language (HTML) format such that displayed text may include hyperlinks to additional information, images, or formatted text.
  • Display 620 can further provide a mechanism for displaying videos stored, for example in the moving picture experts group (MPEG) format, Apple's QuickTime format, or DVD format.
  • Display 620 can additionally include an audio source (e.g., a speaker) to produce audible instructions, sounds, music, and the like.
  • Input region 640 can include keys 660.
  • input region 640 can be implemented as symbols displayed on the display 620, for example when display 620 is a touch-sensitive screen. Patient instructions and queries are presented to the patient on display 620. The patient can respond to the queries via the input region.
  • Device 800 also includes cartridge reader 880, which accepts diagnostic test cartridges for reading.
  • the cartridge reader 880 measures the level of a biomarker based on, for example, the magnitude of a color change that occurs on a test cartridge 800.
  • Device 600 also includes probe connections 700, which connect probes (e.g., a probe of weight, temperature, heart rate, variability of heart rate, breathing rate, blood pressure, or blood oxygen saturation) to the device.
  • probes e.g., a probe of weight, temperature, heart rate, variability of heart rate, breathing rate, blood pressure, or blood oxygen saturation
  • Device 600 further includes a communication port 720.
  • Communication port 720 can be, for example, a connection to a telephone line or computer network.
  • Device 600 can communicate the results of patient tests to a health care provider from a remote location. Likewise, the health care provider can communicate with the device 600 (e.g., to access stored test results, to adjust device parameters, or send a message to the patient).
  • Cartridge 800 is shown with two testing zones 820. In general, a cartridge can include 1, 2, 3, 4, or 5 or more testing zones. Each testing zone 820 can test the level of a biomarker. Each testing zone 820 includes a sample input 840, a fluid reservoir 850, a control result window 860 and a test result window 880.
  • the cartridge 800 is an immunochromatographic test cartridge. Examples of immunochromatographic tests and test result readers can be found in, for example, U.S.
  • a patient can use device 600 for testing and recording the levels of various biomarkers that provide information about the patient's health.
  • Various implementations of diagnostic device 600 may access programs and/or data stored on a storage medium
  • VCR video cassette recorder
  • DVD digital video disc
  • CD compact disc
  • floppy disk e.g., video cassette recorder (VCR) tape or digital video disc (DVD); compact disc (CD); or floppy disk
  • various implementations may access programs and/or data accessed stored on another computer system through a communication medium including a direct cable connection, a computer network, a wireless network, a satellite network, or the like.
  • the software controlling the diagnostic device and providing patient feedback can be in the form of a software application running on any processing device, such as, a general-purpose computing device, a personal digital assistant (PDA), a special-purpose computing device, a laptop computer, a handheld computer, or a network appliance.
  • PDA personal digital assistant
  • a diagnostic device may be implemented using a hardware configuration including a processor, one or more input devices, one or more output devices, a computer-readable medium, and a computer memory device.
  • the processor may be implemented using any computer processing device, such as, a general-purpose microprocessor or an application-specific integrated circuit (ASIC).
  • the processor can be integrated with input/output (I/O) devices to provide a mechanism to receive sensor data and/or input data and to provide a mechanism to display or otherwise output queries and results to a service technician.
  • I/O input/output
  • Input device may include, for example, one or more of the following: a mouse, a keyboard, a touch-screen display, a button, a sensor, and a counter.
  • the display 620 may be implemented using any output technology, including a liquid crystal display (LCD), a television, a printer, and a light emitting diode (LED).
  • the computer-readable medium provides a mechanism for storing programs and data either on a fixed or removable medium.
  • the computer-readable medium may be implemented using a conventional computer hard drive, or other removable medium such as those described above with reference to.
  • the system uses a computer memory device, such as a random access memory (RAM), to assist in operating the diagnostic device.
  • RAM random access memory
  • Implementations of a diagnostic device can include software that directs the patient in using the device, stores the result of biomarker measurements, determines whether a tested biomarker level requires medical attention for the patient, instructs the patient in adjusting or maintaining therapy, and communicates the patient's information to his or her caregiver. At risk patients or patients suffering from, for example, heart failure, can use the device.
  • the device 600 can provide access to applications such as a medical records database or other systems used in the care of patients.
  • the device connects to a medical records database via communication port 620.
  • Device 600 may also have the ability to go online, integrating existing databases and linking other websites. Online access may also provide remote, online access by patients to medical information, and by caregivers to up-to-date test results reflecting the health of patients.
  • the device can be used in the hospital, physician's office, clinic, or patient's home either by the patient or an attendant care giver.
  • the invention is practiced in the patient's home allowing the patient to be monitored, his or her therapy optimized, and adverse events that require hospitalization to be avoided.
  • the device can provide information on the patient's status and provide instructions or other actionable information to the healthcare professional and/or the patient.
  • instructions include: contact caregiver, no change in care plan necessary, change fluid intake, withhold potassium supplementation, increase potassium supplementation, change diuretic dose, withhold diuretic, introduce another diuretic.
  • the objective is to track the patient's condition and steer him or her toward a stable condition through appropriate interventions made by the patient or the caregiver. Algorithms for treatment decisions are known.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Reciprocating Pumps (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

La présente invention concerne des dispositifs qui peuvent comprendre des réservoirs de fluide pour le stockage de faibles quantités de liquide. Des procédés d’enlèvement du liquide stocké dans des réservoirs de fluide peuvent comprendre des activateurs de fluide tels qu’un élément d’indentation, un coulisseau, ou un piston.
PCT/IB2006/003206 2005-11-15 2006-11-14 Reference croisee a des demandes connexes WO2007057744A2 (fr)

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US60/736,302 2005-11-15

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EP3206009A1 (fr) * 2008-08-21 2017-08-16 DNA Genotek Inc. Dispositif de réception d'échantillons
EP2326934A1 (fr) * 2008-08-21 2011-06-01 DNA Genotek Inc. Dispositif de réception d échantillons
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EP3514519A3 (fr) * 2009-12-07 2019-11-06 Meso Scale Technologies, LLC. Cartouches de test
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CN106461695A (zh) * 2014-06-05 2017-02-22 株式会社日立高新技术 生物化学用试剂类保存元件、以及生物化学用分析装置
KR20210135648A (ko) * 2016-11-16 2021-11-15 마이크로플루이딕 칩샵 게엠베하 액체의 수용, 분배, 및 이동을 위한 장치
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KR102450612B1 (ko) 2016-11-16 2022-10-06 마이크로플루이딕 칩샵 게엠베하 액체의 수용, 분배, 및 이동을 위한 장치
DE102016122056B4 (de) * 2016-11-16 2021-02-18 Microfluidic Chipshop Gmbh Mikrofluidisches System zur Aufnahme, Abgabe und Bewegung von Fluiden
WO2018091608A1 (fr) * 2016-11-16 2018-05-24 Microfluidic Chipshop Gmbh Dispositif de prélèvement, d'expulsion et de déplacement de liquides
DE102016015944B3 (de) 2016-11-16 2023-08-31 Microfluidic Chipshop Gmbh Mikrofluidisches System zur Aufnahme, Abgabe und Bewegung von Fluiden
US11859734B2 (en) 2020-11-16 2024-01-02 Siemens Healthcare Diagnostics Inc. Valve for microfluidic device
CN114152759B (zh) * 2022-02-10 2022-04-12 徐州医科大学 一种用于糖尿病肾病早期诊断的引流型试剂盒
CN114152759A (zh) * 2022-02-10 2022-03-08 徐州医科大学 一种用于糖尿病肾病早期诊断的引流型试剂盒

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