Analytical device

Abstract

To provide a self-contained analytical instrument that does not require interaction with other devices or base units to complete the analysis. [Solution] The present invention provides an analytical apparatus comprising: a sample receiving zone; a fluid storage unit that is in fluid communication with the sample receiving zone; an analysis zone that is in fluid communication with the sample receiving zone; and a drive mechanism configured to move the fluid stored in the fluid storage unit when activated, so that it flows through the sample receiving zone to the analysis zone.

Description

Technical Field

[0001] The present invention relates to an analytical apparatus, and more particularly, but not limited thereto, to an analytical apparatus arranged to receive and analyze a sample.

Background Art

[0002] Devices that can receive a sample from a user, process the sample, and analyze it are particularly used in personal diagnostics. Such devices can be used for many diagnostic purposes.

[0003] In order to process and analyze a sample, the device needs to move fluid within the device to perform various actions such as removal of the sample from a sample medium (such as a swab) introduced into the device, rehydration of reagents, mixing of the sample and reagents, dissolution, and separation of the sample into wells for individual analysis.

[0004] On a smaller scale, the analytical apparatus can direct liquid into the apparatus using capillary flow. In other arrangements, diffusion can be used for the transport of molecules of interest suspended in a fluid. However, for example, when a larger amount of fluid is required, either to perform multiple analyses or because a larger amount is needed for the reactions to perform the analysis, a mechanism for transporting fluid through the apparatus is required. Alternatively, or in addition thereto, capillary action may have flow rate limitations, and in some applications, a flow rate faster than that possible by capillary action may be required to enable desired functional steps such as mixing, splitting, and rehydration of reagents.

[0005] Several devices are known that use external drive devices to move fluids within the device. This is particularly relevant when the liquid is moved within the device by a mechanism other than capillary action. Thus, such devices need to be interfaced with a base unit, such as a reading device or other instrument, for the performance of analysis. In one known device, a channel is formed in the rigid substrate of the device and covered with an elastomer membrane. When the device is inserted into the base unit, an actuator engages with the membrane, thereby applying pressure to the channel, and thus the operation of the actuator can move the fluid in the channel, and thus move through the entire device by volume-based displacement (e.g., peristalsis).

[0006] However, the requirement for an external drive unit means that such devices cannot be used separately from their associated base units. This means that either the user must have the base unit and disposable devices with them to complete the analysis, or the user must bring those devices and samples to a central location. [Overview of the project]

[0007] The object of the present invention is to overcome one or more of these limitations.

[0008] The objective of the present invention is to provide a self-contained analytical device that does not require interaction with other devices or base units to complete the analysis.

[0009] In its broadest sense, aspects of the present invention provide an analytical apparatus having a drive mechanism configured to move a fluid within the analytical apparatus.

[0010] A first aspect of the present invention provides an analytical apparatus comprising: a sample receiving zone; a fluid storage unit fluid-communicating with the sample receiving zone; an analysis zone fluid-communicating with the sample receiving zone; and a drive arrangement configured, when activated, to move the fluid stored in the fluid storage unit so that it flows through the sample receiving zone to the analysis zone.

[0011] Preferably, providing a drive mechanism means that the analyzer can operate to analyze a sample brought into the sample receiving zone without input from an external device.

[0012] The analytical device can be self-contained and therefore can be used in locations away from medical facilities. This eliminates the need for sample transport or maintaining sample viability, and enables rapid testing at the location where the sample was obtained.

[0013] Furthermore, this device does not require complex and / or expensive cooperating equipment, such as a base unit, a reader, or other instruments for operating and performing the analysis.

[0014] The analytical device may further include one or more control elements configured to control the flow of fluid within the device.

[0015] For example, in some embodiments, the apparatus may include a control element between the fluid storage unit and the sample receiving zone, which is configured to block the flow of fluid from the fluid storage unit to the sample receiving zone until activated.

[0016] Alternatively, or in addition to the above, one or more control elements may be placed between the sample receiving zone and the analysis zone.

[0017] In some embodiments, the control element is a seal that can be broken when it is desired to allow fluid flow. For example, a seal formed from a fusible plastic layer or a heat-shrinkable plastic layer may be used as the control element.

[0018] In other embodiments, one or more of the control elements may include a microfluidic control gate.

[0019] The drive mechanism may be configured to be activated by the insertion of a sample into the sample receiving zone. This may result from the detection of the presence of a sample in the sample receiving zone, for example, by blocking the light beam with the sample or by a contact switch. In some configurations, the drive mechanism may be configured to be activated only when the sample is inserted into the sample receiving zone and the opening into which the sample is inserted is completely closed or sealed.

[0020] In some embodiments, the drive mechanism uses the action of inserting a sample into a sample receiving zone to move the fluid. In these embodiments, the device may be configured to store the pressure resulting from this action and use that pressure to move the fluid.

[0021] For example, the apparatus may further include a sample carrier configured to be inserted into a sample receiving zone, and the analyzer has an opening into which the sample carrier can be introduced, and the sample carrier has a seal configured to engage with the opening, such that the insertion of the sample carrier into the analyzer causes a gas displacement from the sample receiving zone, and this gas displacement moves the fluid from the fluid storage section into the sample receiving zone.

[0022] The apparatus may further include a gas storage chamber, in which the displacement of the gas causes the gas to move into the gas storage chamber, thereby increasing the pressure within the gas storage chamber, and this pressure within the gas storage chamber is used to move the fluid from the fluid storage section to the sample receiving zone.

[0023] In some embodiments, the drive mechanism includes an energy storage element that stores energy, and when the drive mechanism is activated, it releases the energy to move the fluid stored in the fluid storage section to the sample receiving zone.

[0024] For example, the energy storage element may be a pre-compressed or pre-tensioned elastic element, such as a spring. The elastic element can be used to drive a plunger or other mechanical element, either to directly move the fluid through the device or to generate pressure that can be used to move the fluid.

[0025] In some embodiments, the drive mechanism includes a reactive element, and activation of the drive mechanism causes the reactive element to react and generate a gas, which moves the fluid stored in the fluid reservoir to the sample receiving zone. For example, the generated gas can create an excessive pressure that can be used to move the fluid in part of the device.

[0026] The drive mechanism may further include a stored reactive fluid, and activation of the drive mechanism brings the stored reactive fluid into contact with a reactive element, thereby triggering a reaction between the reactive fluid and the reactive element to produce a gas. For example, carbon dioxide can be produced using an acid and a carbonate. The volume of the gas produced is typically greater than the volume of the reactive fluid and reactive element, and therefore can generate excessive pressure in part of the apparatus.

[0027] In some embodiments, the drive mechanism includes a storage chamber and a heater configured to heat the fluid stored within the storage chamber to increase the pressure within the storage chamber, and the increased pressure is used to move the fluid stored in the fluid reservoir through the device. For example, the liquid stored within the storage chamber may be heated such that it vaporizes to form a gas, thereby causing an increase in the pressure within the storage chamber. Alternatively, the gas within the storage chamber may be heated to increase the pressure.

[0028] The device can further include a manual activation element that enables the user to activate the drive mechanism by moving the manual activation element. Thereby, the user can initiate the operation of the device after insertion of the sample, for example by pulling a tag or a ring pull.

[0029] In some embodiments, the sample receiving zone has an opening through which a sample can be introduced, and the device can be configured to seal the opening in the case of sample introduction.

[0030] Sealing may be effected, for example, using a cap or a stopper, or by means of an interaction between a specially configured sample collection device such as a swab and the opening, which seals the swab against the device. Such an interaction may take the form of one or more sealing elements such as O-rings, or the form of a thread of the opening that engages with a corresponding thread of the sample collection device. In some embodiments, a luer lock or luer taper connection may be used for sealing the opening.

[0031] Alternatively, or in addition, the device may have a cover or a seal for sealing the opening prior to use of the device. This can prevent contaminants from entering the sample receiving zone prior to use of the device. In some embodiments in which the device has a sample collection device configured to interact with the opening, this can provide the seal.

[0032] The analysis chamber preferably includes all the necessary elements for performing the desired analysis of the sample. This may include one or more reagents (which may be in a dry form and can be activated when the fluid containing the sample enters the analysis chamber), a heater, one or more electrodes, and so on.

[0033] In embodiments of the present invention, one or more assays within the analytical chamber may be configured to detect the presence or absence of one or more respiratory viral infections, including influenza A, influenza B, respiratory syncytial virus (RSV), or COVID-19. The assays may further be configured to detect sexual health infections, including HIV, chlamydia, and / or gonorrhea. The device may also be configured to detect the presence or absence of hospital-acquired infections, such as methicillin-resistant S. aureus (MRSA) and C. difficile. These are merely examples of uses in which the device may be used, and it should be understood that embodiments of the present invention encompass the device regardless of the purpose and function of the analytical chamber.

[0034] In some embodiments, the analysis zone further comprises multiple analysis chambers. These analysis chambers may be configured to analyze a sample in different ways and / or for the presence of different analytes. The analysis chambers may also include a control chamber that can be used to verify the correct operation of the instrument.

[0035] Multiple analysis chambers can be arranged in parallel. Arranging the analysis chambers in parallel allows for even distribution of the sample between the analysis chambers, so that the fluid arriving from the sample receiving zone can be evenly distributed among the analysis chambers.

[0036] Preferably, the apparatus is configured to distribute the sample contained in the fluid arriving at the analysis zone evenly (or nearly evenly) between multiple analysis chambers.

[0037] Even distribution of samples is crucial for achieving consistent sensitivity in tests performed in different analysis chambers; uneven distribution increases the risk of false negatives.

[0038] Preferably, the apparatus is configured to fill multiple chambers in parallel (or simultaneously) as the fluid arrives from the sample receiving zone.

[0039] Preferably, the apparatus is configured to evenly (or nearly evenly) divide the fluid arriving from the sample receiving zone among multiple analysis chambers.

[0040] In some embodiments, the geometry of the analysis chamber and / or the fluid pathway leading to the analysis chamber is configured to cause an even distribution of the fluid arriving from the sample receiving zone among multiple analysis chambers. For example, the analysis chambers may have substantially identical volume and structure.

[0041] Preferably, the apparatus is further configured to induce fluid mixing (e.g., disordered mixing) when the fluid passes between the sample receiving zone and the analysis zone. This can be achieved by the structure of the flow path between the sample receiving zone and the analysis zone.

[0042] Fluid mixing can help ensure that the distribution of the sample eluted from the sample receiving zone is homogeneous (or at least more homogeneous) throughout the fluid. Since even distribution of a well-mixed fluid containing the sample can be considered to result in an even distribution of the sample, this can help ensure an even (or nearly even) distribution of the sample between different analysis chambers.

[0043] In some cases, neither fluid mixing nor uniform division is entirely effective in ensuring homogeneous sample distribution between analysis chambers. However, the inventors have found that combining mixing and uniform division can measurably improve the desired outcome of uniform sample distribution between analysis chambers.

[0044] Each of the multiple analysis chambers may include a vent that allows gases within the analyzer to exit the instrument when the fluid is moved from the fluid reservoir through the analyzer. This allows gases present in the analysis chamber to exit the chamber when the fluid arrives from the fluid reservoir. This can prevent an increase in back pressure that could otherwise obstruct the movement of the fluid through the analyzer.

[0045] In some embodiments, the vents are configured to provide equal resistance to gas escape, ensuring that the liquid arriving from the sample receiving zone is evenly distributed among the multiple analysis chambers. This can help to cause even division and distribution of the fluid in parallel among the analysis chambers.

[0046] The vent may have a gas-permeable membrane through which gas can exit the analyzer, while liquids are retained within the instrument. This ensures that all liquids, including samples and reagents, are retained within the instrument, thus reducing or eliminating the risk of any contaminants being released from the instrument into the surrounding environment. The membrane may also be hydrophobic to reduce or eliminate the possibility of liquids escaping from the analyzer through the membrane.

[0047] The membrane may be configured to filter the gas that passes through it. The filter can help remove contaminants or reaction products and keep them within the apparatus, reducing or eliminating the risk of any contaminants being released from the apparatus into the surrounding environment.

[0048] In some embodiments, the apparatus is configured to prevent a liquid from leaving one of the analysis chambers after it has entered it. This can help prevent cross-contamination between the analysis chambers and the reagents present within them.

[0049] In some embodiments, the analyzer is configured to process the analysis of a sample without user intervention after the sample has been inserted into the sample receiving zone.

[0050] Therefore, the device can effectively be considered self-contained, in that once the user provides the sample, it performs all the physical and chemical processes necessary to complete the analysis.

[0051] The apparatus may include a processor (e.g., an ASIC) configured to control the operation of one or more electrical or electronic components within the apparatus. The electrical or electronic components may include a battery, one or more fluid flow control elements, one or more heaters, and one or more analytical components.

[0052] The apparatus of the above embodiment may include some or all of the optional and preferred features described above in any combination, or may not include any of them at all.

[0053] Unless otherwise indicated, any of the features described in relation to one of the above embodiments (including optional or preferred features) are equally applicable in combination with any of the other embodiments described above.

[0054] Embodiments of the present invention are described below as an example with reference to the accompanying drawings. [Brief explanation of the drawing]

[0055] [Figure 1a] Figure 1a shows a top view of an analytical apparatus according to one embodiment of the present invention. [Figure 1b]Figure 1b shows a bottom view of an analytical apparatus according to one embodiment of the present invention. [Figure 2a] Figure 2a shows the insertion of a sample collection device into an analytical instrument and the sample collection device itself according to one embodiment of the present invention. [Figure 2b] Figure 2b shows the integration of a sample collection device into an analytical instrument according to one embodiment of the present invention, as well as the sample collection device itself. [Figure 3] Figure 3 shows an enlarged view of the analysis section of an analytical instrument according to one embodiment of the present invention. [Figure 4a] Figure 4a shows a partial diagram of the mechanism by which fluid is moved through an analytical device according to one embodiment of the present invention. [Figure 4b] Figure 4b shows a partial diagram of the mechanism by which fluid is moved through an analytical device according to one embodiment of the present invention. [Figure 5] Figure 5 shows the drive mechanism formation portion of an analytical device according to one embodiment of the present invention. [Figure 6] Figure 6 shows the drive mechanism formation portion of an analytical device according to one embodiment of the present invention. [Figure 7] Figure 7 shows the valve and pressure accumulation section forming part of an analytical apparatus according to one embodiment of the present invention. [Figure 8] Figures 8a and 8b show the drive mechanism formation portion of an analytical device according to one embodiment of the present invention. [Figure 9] Figure 9 shows a mechanism for detecting the presence of a sample collection device in an analytical device according to one embodiment of the present invention. [Modes for carrying out the invention]

[0056] Embodiments of the present invention are shown below. First, an overview of one embodiment of the analytical apparatus is provided. Next, variations of several components of the apparatus are described. Unless otherwise specified, these variations may be combined with other features of the apparatus, or with any combination of variations of other components.

[0057] Figure 1 shows a schematic of an analytical apparatus 10 according to one embodiment of the present invention. Figure 1a shows one side of the apparatus 10, and Figure 1b shows the opposite side of the apparatus 10. The apparatus 10 is formed from a substantially flat substrate 100, the substrate 100 having a plurality of fluid channels 110 formed thereon, along with further components as described below. The substrate is typically made of a rigid plastic material. The substrate 100 and the fluid channels 110 can be formed by any known manufacturing method, such as thermoforming or injection molding. As shown in Figures 1a and 1b, the fluid channels 110 may be formed on both sides of the substrate 100 and may alternate between them. Such an alternating arrangement can induce disordered flow and thus promote mixing of the fluid passing through the channels 110.

[0058] The apparatus 10 has a fluid reservoir 120 that contains the fluid (in this embodiment, a liquid) used during the analysis. This liquid may be, for example, a lysis buffer and / or may contain reagents used in the analysis performed by the apparatus. The fluid reservoir 120 has an outlet port 122 through which the liquid can exit the fluid reservoir and proceed through fluid channels to other parts of the apparatus 10. The fluid reservoir 120 is generally described as being at the “upstream” end of the apparatus, and the fluid engineering parts of the apparatus further away from the fluid reservoir are referred to as “downstream.”

[0059] The outlet port 122, or the fluid channel downstream of the outlet port 122, is preferably sealed to prevent liquid from flowing out of the fluid reservoir until the device 10 is put into use. The seal on the outlet port 122 may be configured to be sealed by a seal 123 (such as a membrane) that crosses the port or the fluid channel and is designed to break when the device is started.

[0060] In some embodiments, the seal has a resistive wire passing through it, and when current flows through the resistive wire, the seal melts, allowing the liquid to flow out through the outlet port 122. In other embodiments, a surface-mount resistor may be placed beneath the seal, and when a voltage flows through it, it generates enough heat to melt the material forming the seal. Examples of sealing materials include HPB900, EVA, or polystyrene, which tend to melt when heated and then contract in response to the application of heat, thereby forming a hole through which the liquid can pass. The liquid flow may be caused by forces exerted upstream of the seal and / or by pressure differences present across the port.

[0061] Other seals or "gates" may be provided to control the flow of liquid through the apparatus 10 and / or to keep liquid in a particular part of the apparatus for a period of time or while other operations such as mixing or heating are performed on the liquid upstream of the gate. These gates may have a configuration similar to the seal of the outlet port 122 described above.

[0062] The apparatus 10 may be configured to control the flow of liquid through the apparatus by controlling the timing of breaking these gates. This may allow the apparatus to control the length of time the liquid spends in certain parts of the apparatus that may be critical, such as controlling the elution of a sample and / or the mixing of the sample with the working fluid, or controlling the flow of liquid into the analysis chamber.

[0063] The activation of the liquid flow may be performed by a microprocessor (such as an ASIC) or by a circuit, which is designed to activate a specific component after a certain predetermined time period has elapsed following an earlier event or trigger (such as the insertion of a sample into the device).

[0064] In the apparatus 10 shown in Figure 1, the area downstream of the outlet port 122 of the fluid storage unit 120 is the sample receiving zone 130. The sample receiving zone 130 is configured to receive a sample from the user.

[0065] In the embodiment shown in Figure 1, the sample receiving zone 130 is configured to receive a sample collection device 133 (as shown in Figure 2), which the user uses to obtain a sample through the opening 138. Figure 2a shows the apparatus 10 with the sample collection device 133 inserted. Figure 2b shows the sample collection device 133 separated from the apparatus 10.

[0066] The sample collection device 133 comprises a swab 134 (which may be flocked) and an elongated arm 132. The arm 132 has one or more sealing elements (such as an O-ring 139) which engage with the opening 138 of the sample receiving zone to form a fluid seal, preventing any liquid or gas from escaping the device 10 from the sample receiving zone. The sample collection device 133 may have a locking mechanism, such as a screw thread or torsion lock mechanism, to secure it to the opening 138.

[0067] The sample receiving zone 130 has an outlet port 131 that allows fluid to pass from the sample receiving zone toward the downstream elements of the device. The outlet port 131 may have a seal or gate, which may be configured as described above, for sealing the outlet port 122 of the fluid storage unit 120.

[0068] The liquid passes through an elongated spiral channel 140 from the outlet port 131. This channel 140 is designed to facilitate mixing of the liquid in both longitudinal (along the liquid column) and transverse (across the width of the channel) directions, as well as the sample eluted into the liquid from contact with the liquid in the sample receiving zone.

[0069] The spiral channel 140 terminates in an intermediate reservoir 142 having a sealed outlet port 144. An air vent 143 is provided within the intermediate reservoir 142 to ensure that the chamber is completely filled with liquid before it flows further through the instrument. The intermediate reservoir 142 has a sample released and suspended from the sampling device 133 and allows for the collection of liquid before it passes through the instrument and proceeds to the subsequent analysis section of the instrument.

[0070] From the intermediate reservoir 142, the liquid flows to the analysis section 150. This section includes a distribution hub 152 connected to each of the multiple analysis chambers 160a–160d, and a flow-dependent transient air spring 156 with an air vent 157 (also referred to as an overflow) at its downstream end. Furthermore, an optional permanent air spring 154 is also shown in Figure 1a, which, if present, serves to maintain back pressure in the distribution hub 152. However, the permanent air spring 154 is not required for the normal operation of the apparatus. Figure 3 is an enlarged view of the analysis section 150, which is given the same reference numerals as the components shown in Figures 1 and 2.

[0071] The analysis chambers 160a to 160d are configured to have inlet channels of similar (ideally identical, or as close to identical as possible within manufacturing tolerances) volumes and similar (similarly, ideally identical, or as close to identical as possible within manufacturing tolerances) dimensions. This, combined with the fluid flow rate in the distribution hub and the flow-dependent air spring that provides ventilation to the atmosphere, helps ensure that the liquid entering the distribution hub 152 is distributed evenly and in parallel between the analysis chambers.

[0072] Each of the analysis chambers 160a to 160d in this embodiment has a narrow inlet passage 162 connected to the distribution hub 152 and the analysis well 164. An air vent 166 is located distal to the inlet passage 162 and is connected to the analysis well 164. The air vent 166 can discharge air from inside the analysis chamber to the outside of the apparatus 10 when liquid from upstream components fills the analysis chamber.

[0073] Air vent 166 is formed of a hydrophobic, gas-permeable membrane. Air vent 157 of the temporary air spring 156 also has a hydrophobic, gas-permeable membrane. These membranes allow the gas initially present in the analysis well 164 or the temporary air spring 156 (and the remainder of the fluid channel) to be discharged from the device by the movement of liquid through the device, while all liquid and particulate matter are retained within the device. Therefore, the gas exiting through the membrane does not actually contain any airborne products as a result of the analysis, which could contaminate the user's environment and jeopardize the conduct of future tests.

[0074] The membrane may be configured to embody a flow-dependent air spring that permeates to the atmosphere. This creates back pressure. This back pressure is generated within the analysis chamber 160 as air pushes the liquid out of the channel and analysis chamber, thereby making it at least partially more difficult for liquid to flow from the distribution hub 152 into the analysis chamber. This back pressure increases with the liquid flow rate and can help ensure that the liquid is evenly distributed from the distribution hub 152 into each analysis chamber 160. If more liquid enters one of the analysis chambers 160 from the distribution hub 152, the flow rate in this channel is greater than the flow rate in the channel with less liquid, so the back pressure generated by the membrane in that chamber is greater than the back pressure in the other chambers. Thus, the flow rate in the more filled analysis chamber decreases compared to the less filled analysis chamber. This means that the liquid in the distribution hub preferentially enters the less filled analysis chambers because the back pressure in the less filled chambers is lower and therefore there is less resistance to the liquid entering these chambers.

[0075] The hydrophobic films of the vents 166 of each analysis chamber 160 and vent 157 of the temporary air spring 156 provide resistance and resulting back pressure until the liquid comes into contact with the respective film, at which point the pressure drops to zero. The temporary air springs thus created are physically separate and isolated, and therefore operate in parallel with each other.

[0076] The vent 157 of the temporary air spring 156 is configured to generate back pressure so that the air spring 156 can be filled with lower priority than the analysis chamber 160. This ensures that the analysis chamber 160 is the first to be filled with fluid that has reached the distribution hub 152.

[0077] The overflow section 156 provides a true (or permanent) air spring, and the air pocket trapped at the end of this channel is released only after the analysis chamber 160 is completely filled, thus providing a means to mitigate backflow from the filled chamber by the excess liquid present in the overflow section 156.

[0078] The membrane can also serve to filter the gases leaving the device, ensuring that larger and more complex molecules, including reaction products from the analytical reaction, remain within the device. This can help ensure that contaminants do not escape from the device into the surrounding environment.

[0079] The distribution hub 152 and / or inlet passage 162 and / or analysis chamber 160 may be further configured to prevent liquid that has entered one of the analysis chambers 160 from leaving that chamber and re-entering the distribution hub 152. This prevents any mixing of reactants between the analysis chambers and thus prevents the possibility of false results resulting from cross-contamination between the respective analysis chambers 160.

[0080] This mixing prevention can be achieved by several methods. In some embodiments, a valve, such as a duckbill valve, may be provided in the inlet passage 162 or at the junction between the inlet passage and either the analysis well 164 or the distribution hub 152.

[0081] In other embodiments, an expandable filler compound, such as a hydrogel, may be placed inside or at one end of the inlet passage 162. The filler compound is configured to expand upon contact with a liquid so as to form a solid barrier across the inlet passage 162 when the liquid is in contact with the filler for a predetermined period of time. Thus, the filler may be configured to seal the inlet passage when the analysis well 164 is filled with liquid.

[0082] In one variant of this embodiment, the analysis section 150 includes an overflow section 156 connected to a distribution hub 152. Excess liquid from the fluid storage / sample chamber that is not needed for the analysis chamber 160 flows into the overflow section 156. Alternatively, or in addition, the connection between the overflow section 156 and the distribution hub 152 may be initially sealed with a seal or gate as described above, and the apparatus is configured to break the seal after a predetermined time when it is estimated that sufficient liquid has entered the distribution hub to fill the analysis chamber. This ensures that the drive pressure in the system is reduced to zero after the apparatus has finished operating.

[0083] Apparatus according to embodiments of the present invention has one or more mechanisms that move the fluid flow through the apparatus from a fluid storage section to an analysis chamber. To operate the apparatus without an external drive or power source, these mechanisms store energy used to selectively increase the pressure in one or more sections of the fluid passages of the apparatus. The fluid passages may be constructed to allow for an increase in pressure within some sections of the apparatus before releasing the fluid to flow through the sections following the fluid passages. This can be achieved by gates or seals as described in relation to the embodiments above, or by valves or other known fluid flow control mechanisms.

[0084] Some examples of drive mechanisms are shown below. It will be understood that any of these examples, including any or all of the optional features of such a device, can be used in a device according to one embodiment of the present invention, and that these mechanisms can be combined as desired. Furthermore, it will be understood that these examples are not limiting, and devices including other mechanisms are also encompassed by the present invention.

[0085] In the embodiment shown in Figure 1, the drive mechanism 200 takes the form of a spring-loaded plunger 210. The plunger 210 has a seal 211 that contacts the wall of the fluid reservoir 120. A compression spring 212 biases the plunger toward the outlet port 122. However, in the housing position, the plunger is held in place by a locking mechanism 213. In the embodiment shown in Figure 1, when the drive mechanism 200 is actuated by pulling a ring pull 214, the locking mechanism 213 is released, and the spring 212 biases the plunger 210 toward the outlet port 122, thereby compressing the liquid in the fluid reservoir 120. The spring 212 may be selected such that the compression achieved is sufficient to move the fluid from the fluid reservoir 120 through the rest of the device 10. However, in the embodiment of the present invention, the pressure is held in the fluid reservoir 120 until the actual flow of fluid through the rest of the device can be controlled by the seal at the outlet port 122 as described above.

[0086] Figure 4 shows the configuration of the spring 212 and the locking mechanism 213 in more detail, with Figure 4a showing the spring 212 and the locking mechanism 213 together, while Figure 4b shows the locking mechanism 213 without the spring. In this embodiment, the locking mechanism is connected to a pull bar 214' used to actuate the drive mechanism. The pull bar 214' is further connected to a cap 215 configured to cover and close the opening 138 to the sample chamber 130 before use of the device. This not only prevents dirt or other contaminants from entering the sample chamber 130 before use, but also prevents the user from inserting a swab prematurely.

[0087] As shown in Figure 4b, the locking mechanism 213 includes a plurality (three in this embodiment) of locking pins 216 arranged around a central channel 217. The locking pins are generally hook-shaped and pivotably connected to the body 218 of the locking mechanism, and are biased into a retracted position as shown in Figure 4b. By inserting the pin 219 through the central channel 217, the locking pin pivots, thereby moving the hooked tip radially outward beyond the outer circumference of the body 218. This causes the hook of the locking pin to prevent the expansion (upward as shown in Figure 4) of the spring 212, keeping the compressed spring 212 in place.

[0088] Removing pin 219 releases lock pin 216, which pivots inward toward the now-empty central channel, thus releasing spring 212, which in turn can drive plunger 210.

[0089] Figure 5 shows another embodiment of the drive mechanism 200. In this embodiment, the drive mechanism 200 is a chemical-based mechanism. In this mechanism, two reactive substances are brought into the apparatus but are kept separate before the apparatus is started. At startup, these substances can be combined or forced into contact and react. The reaction causes an expansion of a limited volume, which results in an increase in pressure used to move fluid through the apparatus. For example, the reaction can produce a gas such as carbon dioxide from a combination of two liquids or a solid and a liquid. The resulting gas naturally occupies a considerably larger volume than the reactants and therefore causes an increase in pressure.

[0090] In certain embodiments, the reaction involves a combination of a solid carbonate (such as sodium bicarbonate) and an acid (such as acetic acid), or other similar effervescent reactions between a liquid and a solid. This reaction produces carbon dioxide. The reagents required to produce this reaction are inexpensive, readily available, and very stable.

[0091] Figure 5 shows one embodiment of such a drive mechanism 200. In this embodiment, there are two containers 230, 231 connected by a passage 235 formed in the substrate of the device.

[0092] The first container 230 holds the liquid 232. The first container 230 has a rigid outer wall and a flexible inner wall which may be formed from an elastomer material. When the first container 230 is filled with the liquid (e.g., acid) 232, the inner wall of the container 230 becomes taut. A membrane 233 seals the liquid 232 inside the container 230. The membrane may be as described above in relation to a gate used elsewhere in embodiments of the apparatus to control the flow of fluid. By breaking the membrane 233 (e.g., by passing an electric current through a resistive heating element in contact with the membrane 233), the liquid 232 is released and flows along the passage 235 toward the second container 231, as shown by the arrows in Figure 5. If the elastomer inner wall is taut, it further pushes the liquid out of the container 230 along the passage 235.

[0093] The second container 231 holds the working fluid 236 of the apparatus, such as a solubilizing buffer. A gas-permeable hydrophobic membrane 234 is positioned at the inlet from the passage 235 to the second container 231.

[0094] Near the inlet of the second container 231, a certain amount of solid reactant (e.g., carbonate) 231 is placed in an aperture formed at the bottom of the substrate beneath the membrane 234, for example, to create a small well below the inlet of the second container. The reaction between the liquid 232 and the carbonate produces carbon dioxide, which passes through the membrane 234 and collects in a gas bubble 237 above the liquid 236 in the second container 231. In some embodiments, heat from a resistive heating element may be used to facilitate this reaction.

[0095] The membrane 234 allows gases from the reaction to pass through and enter the second container 231, but prevents the working fluid 236 from leaving the second container 231 and prevents any liquid 232 from the first container from entering the second container 231 and mixing with the working fluid 236.

[0096] The carbon dioxide produced from the reaction between the liquid and the carbonate naturally occupies a larger volume than the reactants that produced it, and consequently the pressure inside container 231 increases.

[0097] When the gas pressure in the bubble 237 (and the second vessel 231) reaches a desired level, the meltable membrane 238 is broken by heating by a resistor 239 located beneath the membrane 238 and in contact with its underside, for example, as described above in relation to a gate used elsewhere in embodiments of the apparatus to control the flow of fluid. This allows the gas pressure in the bubble 237 to move the working fluid 236 forward through the melted membrane and forward through the channel 233 to the end of the apparatus.

[0098] Figure 6 shows another embodiment of the drive mechanism 200. The drive mechanism 200 has a container 220 containing a certain volume of liquid working fluid (such as a dissolution buffer) 222. A membrane 226 seals the outlet from the container 220. The membrane 226 is meltable and, as described above, in relation to a gate used elsewhere in embodiments of the apparatus to control the flow of fluid. A resistor 228 is located beneath the membrane 226 and is in contact with the underside of the membrane.

[0099] When the device is started, an electric current is passed through the resistor 228, which heats the membrane 226, causing the membrane 226 to rupture. This allows the working fluid 222 from the container 220 to come into contact with the hot resistor 228, thereby vaporizing some of the working fluid. The gaseous working fluid then permeates back through the liquid layer of the working fluid 222, creating a gas bubble 225 at the top of the container 220. This gas brings more working fluid 222 into contact with the resistor 228, thereby continuing the vaporization process. The presence of gas 225 in the container 220 increases the pressure inside the container, thus generating a force that can be used to distribute the fluid throughout the device. As described elsewhere, other membranes or gates may be used to control the flow of the working fluid 222 and / or to hold the working fluid 222 in the container 220 until a desired pressure is accumulated.

[0100] Figure 7 shows the arrangement of a one-way valve that may be used to store pressurized gas within the apparatus before it is used to move the working fluid through the apparatus. The valve configuration is similar to that of the vessel described above and shown in Figures 5 and 6.

[0101] Valve 240 has a container 242 that holds a working fluid 244 (e.g., a lysis buffer) used in the analytical instrument. A gas-permeable hydrophobic membrane 243 is positioned at the inlet from a passage 241 from a drive mechanism (such as one of the drive mechanisms described above) that generates pressurized gas. The gas-permeable hydrophobic membrane 243 allows pressurized gas to pass into container 242 but prevents the working fluid 244 from leaving container 242. The gas generates bubbles 245 on the working fluid 244.

[0102] Pressurized gas from the drive mechanism is stored in bubble 245. When the gas in the bubble reaches a desired pressure (which may be measured or predicted at a specific time interval after the drive mechanism is activated), the molten film 246 is broken, for example, by heating by a resistor 247 located beneath the film 246 and in contact with its underside, as described above with respect to a gate used elsewhere in embodiments of devices for controlling fluid flow. This allows the pressure of the gas in bubble 245 to move the working fluid 244 through the molten film and then through the fluid channel 248 to other parts of the device.

[0103] Figures 8a and 8b show other embodiments of the drive mechanism 200. In this embodiment, the drive mechanism uses energy from the user's actions to insert the sample collection device 133 into the sample chamber 130. Figure 8a shows the sample collection device 133 beginning to be inserted, and Figure 8b shows the sample collection device when fully inserted.

[0104] In addition to the swab 134 containing the sample to be examined, the sample collection device 133 has three elongated sections: a distal section 135, an intermediate section 136, and a proximal section 137. These sections are substantially cylindrical elements with different cross-sections. In the embodiments shown in Figures 8a and 8b, the sections are substantially cylindrical, but they may have other shapes. The cross-sections of sections 135, 136, and 137 narrow from the proximal section 137 towards the distal section 135. These cross-sectional changes may be tapered or non-tapered. Some of the cross-sectional changes are substantially identical to the cross-sectional changes of the sample chamber 130, as shown in Figure 8b, and when the sample collection device 133 is fully inserted into the sample chamber 130, a small gap remains between the proximal section 137 and the intermediate section 136 and their respective parts of the sample chamber 130.

[0105] Two O-ring seals 252 and 253 are positioned where the cross-section of the sample collection device 133 changes. These seals engage with the inner wall of the sample chamber 130 when the user inserts the sample collection device 133. As shown in Figure 8a, when the sample collection device 133 is inserted, the seals 252 and 253 engage with the inner wall of the sample chamber at the same point. This traps a certain volume of air 255 between seals 252 and 253. By further inserting the sample collection device 133 into the sample chamber, this volume decreases, as shown in Figure 8b. The trapped air 255 is pushed out of the sample chamber through port 254, and the pressure generated by this movement can be used to move the fluid flow through the device.

[0106] As shown in Figure 8b, the swab 134 remains within the reduced portion of the sample chamber 130 that surrounds the distal section 135 of the sample collection device 133. Fluid from the fluid storage chamber can pass around the swab 134 in this portion of the chamber and exit through the outlet port 131 to the rest of the device.

[0107] Figure 9 shows an apparatus that may be used to detect the insertion of a sample collection device into the sample chamber 130. Figure 9 shows a portion of apparatus 1 as shown in Figures 1 and 2, with prominent components given the same reference numerals.

[0108] The light-emitting diode (LED) 170 is positioned adjacent to the sample chamber 130. The LED 170 is configured to emit light toward the photodiode 171 through the portion of the sample chamber 130 distal to the opening 138. Complete insertion of the sample collection device into the sample chamber blocks the beam between the LED 170 and the photodiode 171. This beam blockage may be used to activate other components of the device 1, such as the drive mechanism 200 and / or gates that block / allow the flow of fluid through multiple parts of the device. The activation of the device may be carried out by a microprocessor, such as an ASIC, which controls the activation of components such as the drive mechanism and / or gates. The activation of components may be configured to occur in a predetermined sequence or at predetermined time intervals after insertion of the sample collection device to control the flow of fluid through the device and / or the mixing of the fluid with the sample.

[0109] In other embodiments, an alternative approach may be used to detect the insertion of a sample collection device into the sample chamber, for example, by using a contact switch located in or near the opening 138, which is closed by the action of inserting the sample collection device into the sample chamber 130.

[0110] The above configuration ensures that the device operates only when the sample collection device is correctly inserted into the sample chamber and therefore ready for operation.

[0111] However, in further embodiments, the operation of the device may be triggered by an alternative approach. For example, if the operation of the drive mechanism 200 occurs due to user intervention (e.g., by pulling the pull ring 214 in the embodiments shown in Figures 1 and 2), this operation may be detected and used to initiate and / or control the operation of the device and / or other parts of its operation. In yet another embodiment, the operation of the device may be triggered by a specific user interaction, such as pressing a button to close a switch or other electrical contact.

[0112] The above description is essentially illustrative, and those skilled in the art will understand the variations and modifications of the disclosed embodiments within the claims. The claims define the present invention. [Explanation of Symbols]

[0113] 1 device 10 Analyzer 100 circuit boards 110 fluid channels 120 Fluid storage section 122 Exit Port 123 Seals 130 Sample reception zone, sample chamber 131 Exit Port 132 Arm 133 Sample collection device, sampling device 134 Swabs 135 Distal Section 136 Intermediate Section 137 Proximal Section 138 Opening 139 O-rings 140 channels 142 Intermediate Reservoir 143 Air vent 144 Exit Port 150 Analysis Sections 152 distribution hub 154 Air spring 156 Air spring, overflow section 157 Air vent 160a~160d Analysis Chamber 162 Entrance passage 164 analytical wells 166 Air Vent 170 Light-Emitting Diodes 171 Photodiode 200 Drive mechanism 210 Spring Load Plunger 211 Seals 212 Compression spring 213 Locking mechanism 214 Ring pull, pull ring 214' Pull bar 215 Cap 216 Locking pins 217 Central Channel 218 Main Unit 219 pins 220 Container 222 Working fluid 225 Gas bubble, gas 226 Membrane 228 Resistor 230 Container 231 Containers, solid reactants 232 Liquid 233 Membrane, Channel 234 Membrane 235 aisle 236 Liquids, working fluids 237 Gas Bubble 238 Membrane 239 Resistor 240 valves 241 Passage 242 Container 243 Membrane 244 Working fluid 245 Bubble 246 Membrane 247 Resistor 252 O-ring seals 253 O-ring seal 254 ports 255 air

Claims

1. It is an analytical device, Sample reception zone and, A fluid storage section that is in fluid communication with the sample receiving zone, The sample receiving zone and the analysis zone are in fluid communication, When activated, the drive mechanism is configured to move the fluid stored in the fluid storage unit so that it flows through the sample receiving zone to the analysis zone. An analytical device equipped with the following features.

2. The analytical apparatus according to claim 1, further comprising a control element between the fluid storage unit and the sample receiving zone, wherein the control element is configured to block the flow of fluid from the fluid storage unit to the sample receiving zone until activated.

3. The analytical apparatus according to claim 1 or 2, wherein the drive mechanism is configured to be activated by the insertion of a sample into the sample receiving zone.

4. The analytical apparatus according to claim 3, wherein the drive mechanism moves the fluid using the action of inserting the sample into the sample receiving zone.

5. The analyzer according to claim 4, further comprising a sample carrier configured to be inserted into the sample receiving zone, wherein the analyzer has an opening into which the sample carrier can be introduced, and the sample carrier has a seal configured to engage with the opening, such that insertion of the sample carrier into the analyzer causes a gas to be released from the sample receiving zone, and the gas to be released causes a fluid to move from the fluid storage unit to the sample receiving zone.

6. The analytical apparatus according to claim 5, further comprising a gas storage chamber, wherein the displacement of the gas causes the gas to move into the gas storage chamber, thereby increasing the pressure within the gas storage chamber, and the pressure within the gas storage chamber is used to move a fluid from the fluid storage section to the sample receiving zone.

7. The analytical apparatus according to any one of claims 1 to 6, wherein the drive mechanism includes an energy storage element, the energy storage element stores energy, and when the drive mechanism is activated, releases the energy to move the fluid stored in the fluid storage section to the sample receiving zone.

8. The analytical apparatus according to claim 7, wherein the energy storage element is an elastic element that has been pre-compressed or pre-tensioned.

9. The analytical apparatus according to any one of claims 1 to 8, wherein the drive mechanism includes a reactive element, and the activation of the drive mechanism causes the reactive element to react such that it generates a gas, and the generated gas moves the fluid stored in the fluid storage section to the sample receiving zone.

10. The analytical apparatus according to claim 9, wherein the drive mechanism further includes a stored reactive fluid, and activation of the drive mechanism brings the stored reactive fluid into contact with the reactive element, thereby causing a reaction between the reactive fluid and the reactive element to generate the gas.

11. The analytical apparatus according to any one of claims 1 to 10, wherein the drive mechanism includes a storage chamber and a heater configured to heat a fluid stored in the storage chamber to increase the pressure in the storage chamber, and the increased pressure is used to move the fluid stored in the fluid storage section through the apparatus.

12. The analytical apparatus according to any one of claims 1 to 11, further comprising a manual activation element that enables a user to activate the drive device by moving the manual activation element.

13. The analytical apparatus according to any one of claims 1 to 12, wherein the sample receiving zone has an opening into which the sample can be introduced, and is configured to seal the opening when the sample is introduced.

14. The analytical apparatus according to any one of claims 1 to 13, further comprising a fluid passage between a sample collection zone and the analysis zone, wherein the fluid passage is configured to mix the sample contained in the fluid passing through the fluid passage with the fluid.

15. The analytical apparatus according to any one of claims 1 to 14, wherein the analytical zone further comprises a plurality of analytical chambers.

16. The analytical apparatus according to claim 15, wherein the plurality of analytical chambers are arranged in parallel.

17. The analytical apparatus according to claim 16, wherein the plurality of analytical chambers are configured to evenly distribute the sample contained in the fluid that has reached the analytical zone.

18. The analytical apparatus according to claim 17, wherein the plurality of analytical chambers are configured to evenly divide the fluid that has arrived from the sample receiving zone.

19. The analytical apparatus according to claim 18, wherein the geometry of the analysis chamber and / or the fluid path leading to the analysis chamber is configured to cause an even distribution of the fluid arriving from the sample receiving zone among the plurality of analysis chambers.

20. The analytical apparatus according to any one of claims 15 to 19, wherein each of the plurality of analytical chambers includes a vent, and when a fluid is moved from the fluid storage unit through the analytical apparatus, the vent is configured to release gas from within the analytical apparatus.

21. The analytical apparatus according to claim 20, wherein the vent is configured to provide equivalent resistance to gas escape, so that the liquid arriving from the sample receiving zone is evenly distributed among the plurality of analytical chambers.

22. The analytical apparatus according to claim 20 or 21, wherein the vent has a gas-permeable membrane through which the gas can pass out of the analytical apparatus, while the liquid is retained within the apparatus.

23. The analytical apparatus according to claim 22, wherein the membrane is configured to filter out gases that pass through it.

24. The analytical apparatus according to any one of claims 15 to 23, wherein the apparatus is configured to prevent the liquid from leaving one of the analytical chambers after the liquid has entered one of the analytical chambers.

25. The analytical apparatus according to any one of claims 1 to 24, configured to process the analysis of a sample without user intervention after the sample has been inserted into the sample receiving zone.

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