This invention relates to a liquid sample collection apparatus and in particular to a liquid sample collection apparatus for the collection of blood samples.
In patient populations with chronic conditions living some distance from hospitals, collection of a series of blood samples to monitor disease activity in a timely fashion is difficult. The ability to monitor markers of inflammation and gauge a patient's response to treatments for example in arthritis patients, is not just important in early stage disease but also in patients with established disease. Patients with chronic arthritis tend to lose self-confidence in managing their condition and a substantial proportion can suffer recurrent disease flare-ups. These flare-ups are costly in terms of appointments with GP's and specialist clinics and result in significant work disability.
Being able to reliably define and report a disease ‘flare’ in arthritis is currently problematic as there are no objective measures available to the patient while at home. The clear definition of a flare would help justify an increase in immunosuppressant dose or a course of steroids. Currently patients make a visit to their local GP or hospital clinic, at 6 week intervals at best. In reality this means that opportunities to sample during an active ‘flare’ are often missed and an informed intervention is not possible. Home monitoring is constrained by the costs of making phlebotomists available to make frequent home visits to patients.
Also for markers which are unstable at ambient temperatures, blood samples need to be refrigerated and rapidly transported to the analysis laboratory. Therefore there exists the need to provide the ability for the patient to collect their own blood samples in their own home and send these at ambient temperature to a laboratory would enable ‘remote’ monitoring of chronic disease.
Accordingly the present invention provides a liquid sample collection apparatus comprising, a port for receiving a liquid sample, a collector for storing said liquid sample, at least one conduit coupling said port to said collector, and a sample detection apparatus comprising a sensor for detecting said liquid in said collector and generating an output depending on the quantity of said liquid detected in said collector, and a controller responsive to said sensor output and configured to determine that said sample has been collected when said sensor output indicates that a quantity of said liquid above a threshold amount is detected in said collector.
Ideally, the sensor comprises first and second spaced apart electrodes coupled to said collector, said sensor output depending on the electrical conductance of said collector between said first and second electrodes, said electrical conductance depending on the quantity of liquid collected in use by said collector.
Preferably, the sensor comprises an electrical circuit in which said first and second electrodes serve as a switch, said switch being open or closed depending on the electrical conductance of said collector between said first and second electrodes.
Ideally, the first and second electrodes are mechanically connected to each other by said collector and are selectively electrically connected by said collector depending on the electrical conductance of said collector between said first and second electrodes.
Preferably, the first and second electrodes are configured to be electrically connected to each other when a quantity of said liquid above a threshold amount is collected by said collector.
Ideally, one of said electrodes is located adjacent an inlet of said collector, the other of said electrodes being spaced apart from said inlet, preferably at an opposite side of said collector.
Preferably, the other electrode comprises a plurality of electrically connected terminals, said terminals being spaced apart, preferably spaced apart along said opposite side of said collector.
Ideally, said collector comprises a liquid absorbent material, preferably paper.
Ideally, the electrodes are provided on an obverse face and/or a reverse face of said liquid absorbent material, and/or are incorporated into said liquid absorbent material.
Preferably, the collector comprises liquid absorbent material for storing said liquid sample.
Ideally, said liquid absorbent material comprises paper.
Preferably, a quantity of liquid-transportable tracer material is provided in said at least one conduit and is exposed in use to said liquid sample when in said at least one conduit.
Ideally, the tracer material is provided on at least one internal surface of said at least one conduit.
Preferably, the tracer material comprises a chemical compound.
Ideally, the tracer material comprises a dye or a fluorescent material.
Preferably, the at least one conduit is shaped and dimensioned to draw said liquid sample into said collector by capillary action.
Ideally, the conduit is substantially straight or curved.
Preferably, a filter is provided between the port and the collector.
Ideally, the filter is provided in the conduit.
Preferably, the filter comprises a microfluidic filter incorporating a plurality of micro fabricated pillars.
Ideally, the conduit comprises a multi-layer formation.
Preferably, the controller includes, or is co-operable with, data storage means and is configured to create a data record of a detected sample in the data storage means.
Ideally, the detection apparatus is configured to generate one or more user alerts upon detection of a sample.
Preferably, the sample detection apparatus comprises an output means configured to transmit information regarding the sample in the collector via wired and/or wireless transmission means.
Ideally, the information regarding the sample output from the output means comprises the volume of sample obtained and/or the time it was obtained and/or the date it was obtained.
Preferably, the output means comprises a data transfer port such as a USB or Ethernet or a Bluetooth® or NFC or WiFi or BLE transmitter or an active or passive RFID chip.
A second aspect of the invention provides, a liquid sample collection apparatus comprising a port for receiving a liquid sample, a collector for storing said liquid sample, at least one conduit connecting said port to said collector, wherein a quantity of liquid-transportable tracer material is provided in said at least one conduit and is exposed in use to said liquid sample when in said at least one conduit.
Embodiments of the invention are now described by way of example and with reference to the accompanying drawings in which like numerals are used to denote like parts and wherein,
Referring to
The housing 3 incorporates at least one port 11 for the receipt of a liquid sample. The port 11 may take the form of a receptacle with an aperture, typically formed in the upper panel 9, in which a liquid sample can be deposited. The port 11 typically extends through the upper panel 9 and may also extend through one or more of the plurality of layers 5. The port 11 may incorporate a closing means, e.g. a lid (not shown), which is configured to close the port 11 after the deposit of one or more liquid samples, such as to prevent any unwanted dirt or debris from entering therein which may contaminate the sample. The closing means may comprise any suitable electrical or mechanical device such as a cover variable between an open and closed position, were the variation between the positions may be dependent upon one or more electrical sensors. The port 11 may also be provided on any other suitable panel or wall thereof. The liquid typically comprises a bodily liquid such as blood or urine or saliva however it may also comprise any other suitable liquid. The housing 3 typically incorporates a piercing means 13, as shown in
The housing 3 incorporates a collector 19 for storing the liquid sample as shown in
The conduit 15 typically comprises a multi-layer formation as shown in
A filter 17 is typically provided between the port 11 and the collector 19. The filter 17 may be of any conventional type that is suitable for isolating/removing/separating one or more components of the liquid sample from other component(s) of the sample. Not only does this allow the desired portion of the sample to reach the collector but it also can help to prevent blockages or coagulation. The filter 17 is typically provided in the conduit 15, for example at or adjacent the port 11. In cases where the liquid sample comprises a blood sample, the filter 17 advantageously separates/removes one or more components from the blood sample such as cells or plasma or any other component. In a preferred embodiment the filter 17 is suitable for filtering out the cells from the blood to leave only the plasma being drawn through the remainder of the conduit 15 to the collection reservoir 19. The filter 17 typically comprises a microfluidic filter incorporating a plurality of micro fabricated pillars as shown in
At least part of the conduit 15 is typically provided with a quantity of liquid-transportable tracer material 21, which is exposed in use to the liquid sample when in the at least one conduit 15. The tracer material 21 is typically coated upon at least one internal surface of the conduit 15, typically after the filter 17 in the direction of liquid flow, thereby ensuring only the desired isolated components of the liquid are coated. The tracer material 21 is taken up by the liquid sample, after having passed through the filter 17, as it flows toward the collector 19. The arrangement may be such that a thin layer chromatography type principle applies whereby only a certain amount of the tracer material 21 reaches the collector 19 carried by the liquid. The tracer material 21 typically comprises a chemical compound (in any form, e.g. solid, powder, liquid, gel that is suitable for being lifted from the conduit surface and carried by the liquid during use) which may for example be coated or sprayed or pipetted onto the internal surface the conduit 15. The tracer material 21 typically comprises a fluorescent material such as fluorescein or a dye such as texas red or cyanine blue. The tracer element 21 allows for the accurate analysis of the liquid sample, as is described in greater detail further on. In a preferred embodiment the tracer element 21 comprises fluorescein, which is detectable under UV light.
The collector 19 is typically coated in, or otherwise provided with, a stabiliser suitable for facilitating protein preservation over a short period of time. Advantageously this allows the apparatus 1 to be used by the user at home and analysed by a medical professional at a later time. The stabiliser may comprise a polar, branched polysaccharide or any other suitable chemical compound. For example, the stabiliser may comprise a dextran, e.g. in the quantity 10 mM 70 KDa. However alternatively the sample stabiliser may comprise an alginate or other complex polar, branched chain polysaccharide or any other suitable stabiliser. Advantageously as dextran is antithrombotic it also aids the structural stability of any cells contained within the liquid sample.
The liquid sample collection apparatus 1 further comprises a sample detection apparatus 25. The sample detection apparatus 25 typically comprises a sensor 24 for detecting the liquid in the collector 19, and is advantageously configured to generate an output depending on the quantity of the liquid detected in the collector 19. The sample detection apparatus 25 further comprises a controller 30 responsive to the sensor 24 output, which is advantageously configured to determine that the sample has been collected when the sensor 24 indicates that a quantity of the liquid above a threshold amount is detected in the collector 19. The sensor 24 typically comprises an electro conductive sensor which is incorporated within and/or on the collector 19. The sensor 24 (and more particularly the electrodes that are part of the sensor in the preferred embodiment) may be provided on an obverse face and/or a reverse face of the collector 19, and/or incorporated between layers of the collector if the collector comprises a multi-layer structure. The sensor 24 (and in particular the electrodes that are part of the sensor in the preferred embodiment) preferably comprises materials which are inert and which will not compromise the chemical integrity of the sample such as a thin layer of deposit able metal. The sensor 24 is preferably printed on the collector 19, however it may alternatively be coupled via an adhesive or otherwise mounted or coated on the collector.
The sensor 24 typically comprises first and second spaced apart electrodes 26, 27, as shown in
The controller 30 is responsive to the sensor 24 output and is configured to determine that the sample has been collected when the sensor 24 output indicates that a quantity of the liquid above a threshold amount is detected in the collector 19. In preferred embodiments, the controller 30 includes, or is co-operable with, data storage means (e.g. a memory device) and is configured to create a data record of a valid sample, i.e. a detected sample above the threshold quantity, in the data storage means. The data record may include time stamp information, e.g. the date and/or time at which the sample was detected. For example the controller may include, or be co-operable with a data recording apparatus and trigger an electronic time stamp process in response to the sensor 24 output indicating that the quantity of liquid above the threshold amount has been detected. The sensor 24 is typically electrically coupled to the controller 30. The controller may comprise a microprocessor, or microcontroller or any other suitable controller circuit or circuitry, conveniently in IC form. For example, in use where the liquid sample comprises blood and the collector 19 is collecting blood plasma, the sensor 24 is configured to detect when the desired volume of plasma above the threshold amount has been obtained, the sensor then generates an output to the controller 30 which is configured to activate a data recording apparatus and trigger an electronic time stamp process to record when the plasma sample was collected.
The detection circuit 25 may also be configured to activate one or more user alerts upon activation of the data recording apparatus or otherwise upon detection of a valid sample. The user alerts may be generated by one or more audio, haptic and/or visual alert apparatus 31, 32 as shown in
Advantageously, once sufficient volume of the sample has been obtained the user can send the apparatus 1 to a lab for the sample to be assessed by a competent professional. The collector 19, typically comprising filter paper, may be removed from the apparatus 1 and rehydrated to extract biological molecules or drugs. Advantageously, the apparatus 1 is fully disposable so once the collector 19 has been removed for analysis, the remainder of the apparatus 1 may be disposed. The amount of tracer material 21 extracted from the collector 19 can then be related back to the volume of liquid, preferably blood plasma, required to bring the tracer material 21 into the collector 19. Therefore the original volume of plasma which dried within the collector 19 can be calculated.
In an alternative embodiment the apparatus 1 may be modular, typically comprising first and second modules (not shown) which may be coupled together. The first module may comprise the port, collector and conduit and the second module may comprise the sample detection apparatus. Advantageously as the apparatus 1 is typically single use in the embodiments described previously, this modular arrangement would allow for the regular disposal of only the first module which typically comprises low cost components, whilst the second module comprising more expensive components may be used with a plurality of first modules before requiring disposal. This embodiment would also allow a user to collect a plurality of liquid samples over a period of time, for example a week, which could then be analysed on a continual basis.
The apparatus has the potential to be used beyond protein work to include DNA and drug metabolite measurements. It can be applied to many chronic diseases requiring regular monitoring including cancer, diabetes, heart disease and other inflammatory conditions.
The detection circuit 25 could be used where moisture detection is critical to the manufacture of products or in innovative products which require remote monitoring of moisture/liquids in disposable products such as nappies.
The invention is not limited to the embodiment(s) described herein but can be amended or modified without departing from the scope of the present invention.
Number | Date | Country | Kind |
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1521390.3 | Dec 2015 | GB | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2016/079581 | 12/2/2016 | WO | 00 |