Patent Application
20230288297
The present disclosure is in the field of collecting fluid samples to test and analyze particles that are present within the fluid sample.
References considered to be relevant as background to the presently disclosed subject matter are listed below:
Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter.
The present disclosure discloses device and method for extracting a sample of particles, from a fluid sample, such that the sample of particles having a volumetric concentration sufficient for further analysis. This technique is advantageous when the original fluid sample having a volumetric concentration of particles under the threshold for their analysis.
The terms “particles” and “particles of interest” throughout the application refer to non-electrical charged, electrical charged, non-magnetic or magnetic non-organic particles or organic particles including volatile organic compounds (VOCs), non-living or living particles such as airborne microbial agents or microorganisms such as viruses, or other contaminations.
The term “fluid” throughout the application refers to any of gas or liquid, for example the fluid may be gas collected from the environment or chimney or air exhaled by a subject or water sampled from a water container.
The term “analysis” throughout the application refers to any observation, identification, post studies or tests of the sample to derive characteristics of the particles in the sample, identifying their presence, their quantity and/or concentration.
The term “volumetric concentration” throughout the application refers to the quantity of particles per a volume unit.
The term “analysis threshold” throughout the application refers to the minimum of the volumetric concentration level of the particles required for the particles' analysis.
The device includes a fluid inlet for introduction of fluid sample containing particles of interest, e.g. air exhale of a subject into the device, liquid of a water source such as a spring or contaminated gas such as gas from a chimney. The fluid is introduced into the device to flow through a sampling tube from its first end to its second end. The amount of fluid, namely the volume amount that flows through the device is measurable by a volume indicator located at the flow path of the fluid sample in the device. The volume indicator is configured to give an indication about the volume of the fluid that flows through the device, e.g. a flowmeter, a reservoir with tick marks, deformable reservoir with identifiable volumes states or any other means that can gives indication for the volume of fluid sample is introduced into the device. A filter element configured for blocking the flow of the particles along the device to trap them in a trapping zone to thereby extracting the particles from the original fluid sample. The filter may be a porous membrane allowing passing of fluids and blocking the passing of the particles or any other filter that traps the particles of interest in the trapping zone. The trapping zone is defined by a fluid-tight sealed volume upstream the filter such that at least part of the trapping zone is a volume within the sampling tube. After the sampling collection is done, the trapping zone includes a particle sample that has a volumetric concentration of the particles above that of the original fluid sample. The objective is to get a volumetric concentration of the particles above their analysis threshold, and to have indication of their volumetric concentration in the original fluid sample. The increase factor between the volumetric concentration of the extracted particles in the trapping zone and the volumetric concentration of the particles in the original fluid sample is equal to the ratio between the volume of the fluid passing through the sampling tube to the volume of the trapping zone. Since the trapping zone volume is a known parameter and the volume of introduced fluid sample is measurable, the increase factor can be easily derived.
In the embodiment where the volume indicator is a deformable reservoir, there can be two alternatives configurations of locating the deformable reservoir with respect to the sampling tube—upstream or downstream. It is to be noted that the deformable reservoir can be a bag, e.g. a plastic or paper bag or any reservoir that is capable of deformation or any reservoir that is capable of deformation of at least a portion of its walls or by being shaped for allowing it such as a bellow shape or by including a piston.
In the first configuration, the reservoir is located upstream the sampling tube along the flow path of the sampled fluid such that fluid introduced through the inlet is first being received in the reservoir through a reservoir inlet and accumulated therein. After sufficient fluid is accumulated in the deformable reservoir, it is controllably discharged, e.g. by applying a force on the reservoir that forces the fluid to flow through a reservoir outlet into the sampling tube and then out of the device. During the flow of the fluid along the sampling tube, the particles in the fluid are blocked by the filter and are trapped in the trapping zone.
In a second configuration, a reservoir, either a deformable reservoir or a reservoir with identifiable marks, is located downstream the sampling tube and is linked to the second end of sampling tube, i.e. to its outlet portion, and the fluid flows towards the reservoir to fill it with fluid up to the desired amount that is indicated by noticeable accumulation of the fluid within the reservoir up to a certain volume. During the flow of the fluid towards the reservoir, the particles in the fluid are blocked by the filter and are trapped in the trapping zone.
In an optional design of the second configuration, a unidirectional valve is disposed at or between the fluid inlet and the filter. Fluid passing through the unidirectional valve flows towards the filter and the particles in the fluid sample are blocked by the filter to be trapped within the trapping zone. Therefore, the trapping zone is defined by the volume confined between the unidirectional valve and the filter. Optionally, in this configuration, the first end of the sampling tube constitutes the fluid inlet.
Thus, a first aspect of the present disclosure provides a sample collection device for extracting particles from a sample of fluid, e.g. organic, non-organic, volatile organic compounds (VOCs), non-living or living particles such as airborne microbial agents from an air sample of a subject. The device includes a fluid inlet that is configured to receive a fluid therethrough. The fluid may be any of gas or liquid, for example the gas may be air exhaled by a subject, contaminating gas or liquid of a potable water source.
The device further includes a sampling tube with first and second open ends. The first end is upstream the second end with respect to flow path of the sample of fluid through the device, namely the first end being more proximal to the fluid inlet than the second end. The sampling tube includes a filter located between the first and second ends for blocking passage of the particles upon a flow of the fluid therethrough to thereby trapping said particles in a trapping zone defined upstream the filter.
In some embodiments of the device, the volume indicator is a deformable reservoir.
In some embodiments, the deformable reservoir is linked to the first or second ends of the sampling tube. The deformable reservoir can be configured for undergoing deformation upon receiving fluid being introduced through said inlet and to increase its volume from at least a first volume to a second volume. Alternatively, when the deformable reservoir contains fluid sample, it can be pressed by outer force or pressure and be deformed and decreased its volume from a first volume to a second volume, and forces egress flow of the fluid sample from its interior through a deformable reservoir outlet towards the sampling tube, when the deformable reservoir is linked to the first end. It is to be noted that the first volume may be either greater or smaller than the second volume and that the reservoir may undergo reversible transition between its different volume states. The first and second volumes of the deformable reservoir are identifiable such that the user of the device can recognize that sufficient fluid is introduced or discharged from the reservoir.
In the embodiments that the deformable reservoir is fluid-tight coupled to the first end of the sampling tube, the deformable reservoir may be indirectly coupled to the fluid inlet, namely such that fluids that are introduced through the inlet may flow through components of the device before being received in the deformable reservoir. At the first stage the deformable reservoir is being filled with a fluid sample to a desired volume. Later, upon force or pressure pressing on at least a portion of its walls, the volume of the reservoir is decreased from the first volume to the second volume, which is smaller than the first volume, and the fluid is forced to flow into the sampling tube. The volume difference between the first volume and the second volume are indicative by definite forms of the deformable reservoir for the first and second volumes, marks, or pattern of the deformable reservoir.
In the embodiments that the deformable reservoir is located downstream the sampling tube and is linked to the second end, namely, the fluid flows from the fluid inlet, through the sampling tube and into the deformable reservoir, results in an increase of the volume of the reservoir. Marks of the reservoir give indication for the volume of the fluid accumulated in the reservoir. For example, a pattern on the walls of the deformable reservoir can give the desired indication that sufficient volume of fluid is accumulated therein.
In some embodiments, the device further includes a sealing member configured to allow fluid-tight sealing of the volume of the trapping zone, upon the end of the sampling process, namely when sufficient volume of fluid passed through the sampling tube. Therefore, the sealing member can be in two different states, an open state wherein fluid flows into the trapping zone and a sealing state wherein the volume of the trapping zone is sealed.
In some embodiments of the device, the sealing member is configured to seal the first end of the sampling tube.
In some embodiments, the device includes a unidirectional valve that is located at the flow path between the fluid inlet and the filter for allowing introduction of fluid sample into the sampling tube and blocking discharge of fluid sample from the sampling tube towards or via the fluid inlet. In some embodiments, the unidirectional valve is located between the first end and the filter.
In some embodiments of the device, the first end is fluid-tight coupled to the deformable reservoir and the fluid inlet is formed in or disposed upstream the deformable reservoir. The deformable reservoir comprises a deformable reservoir inlet for receiving fluid being introduced via said deformable reservoir inlet. The deformable reservoir fluid inlet is sealable upon filling said deformable reservoir with a fluid to said first volume, and upon connecting the deformable reservoir fluid inlet to the first end and releasing the fluid sample from the reservoir towards the sampling tube, e.g. by applying an external force or pressure on at least a portion of the deformable reservoir walls, the volume of the deformable reservoir decreases to the second volume, and the fluid sample is forced to flow through said sampling tube, thereby causing or forcing said particles for being trapped in said trapping zone.
In some embodiments of the device, the deformable reservoir, in its second volume, is configured to fit into the tube and the sealing member is configured to seal the first end when the deformable reservoir is in the tube.
In some embodiments of the device, the deformable reservoir comprises elastic walls and the deformable reservoir is configured for changing its volume upon a change of the pressure in its interior, namely upon change of forces applied onto its walls. Thus, when the internal pressure of the reservoir increases, so its volume increases and when the internal pressure decreases, its volume decreases. For example, when the deformable reservoir is filled with fluid and the pressure in its interior is above the ambient, the flow of fluid from the reservoir downstream along the flow path is spontaneous. It is to be noted that the deformable reservoir may also undergo, at least in part of its deformation, isobaric deformation, namely a change of volume without the change of its internal pressure.
In some embodiments, the device includes a visual indicator for indicating of sufficient fluid volume that is introduced into the deformable reservoir.
In some embodiments of the device, the indicator is a pattern on the deformable reservoir that is identifiable upon inflation of the deformable reservoir to a sufficient volume.
In some embodiments of the device, the deformable reservoir is configured for changing its volume upon a force acts on at least portion of its walls.
In some embodiments of the device, at least a portion of the walls of the deformable reservoir is elastic.
In some embodiments of the device, wherein at least a portion of the deformable reservoir walls is in the form of a bellows.
In some embodiments of the device, the reservoir has flexible walls for allowing its deformation. It is to be noted that the flexible walls may constitute only a portion of the entire walls of the reservoir.
In some embodiments of the device, the reservoir is inflatable and compressible.
In some embodiments of the device, the deformable reservoir includes a piston.
In some embodiments of the device, the tube is coupled to the deformable reservoir in an attachable/detachable manner for allowing the extraction of the tube from the entire device to facilitate quantification tests of the sample.
In some embodiments of the device, the volume indicator is a non-deformable reservoir linked to the second end of the sampling tube. The reservoir comprises marks for indicating the amount of fluid that is introduced therein.
In some embodiments of the device, the non-deformable reservoir comprises aperture for allowing release of gas from its interior.
In some embodiments of the device, the volume indicator is a flowmeter.
In some embodiments of the device, the flowmeter is located at the flow path between the first and second ends of the sampling tube.
In some embodiments of the device, the flowmeter is located before the sampling tube, namely upstream the first end.
In some embodiments of the device, the flowmeter is located after the sampling tube, namely downstream the second end.
In some embodiments of the device further includes a closure configured for association with the second end in two states: a first state for fluidically sealing the second end and a second state for allowing flow of fluid through the second end.
In some embodiments the volume indicator is constituted by a combination of the flowmeter and the deformable reservoir that are described above.
In some embodiments of the device, the fluid is gas or liquid. In some specific embodiments, the fluid is air exhaled from a subject.
In some embodiments of the device, the inlet is a mouthpiece to allow a subject to exhale air through the fluid inlet into the device.
In some embodiments of the device, the inlet is sealable.
In some embodiments of the device, at least a portion of the trapping zone walls is made of transparent material for allowing visual inspection of its interior.
In some embodiments, the particles are at least one of the following: non-organic, non-electrical charged, electrical charged, nonmagnetic, magnetic, volatile organic compounds (VOCs), non-living particle, and living particles such as microbial agents and viruses.
In some embodiments of the device, the filter is a microbial filter selected from bacterial and viral filter. In some embodiments, said viral filter is configured for filtering out SARS-COV-2 viruses.
In some embodiments of the device, the filter is configured to filter-out particles having a diameter of at least 75 nm, 90 nm or 100 nm and larger.
In some embodiments of the device, the filter is realized by field of force induced in the said sampling tube configured for trapping the said particles in the trapping zone. In some embodiments, the field force is electromagnetic field. In some other embodiments, the field force is acceleration field.
Another aspect of the present disclosure provides a method for extracting particles from a fluid sample, e.g. gas or liquid sample, for further analysis thereof. For example, the gas sample may be an exhale air sample of a subject, and the liquid may be water or any other liquid of interest. The method includes (a) introducing a volume of fluid sample into a sample collection device through a fluid inlet. The sample collection device comprises a sampling tube with first and second open ends, the first end being more proximal to the fluid inlet than the second end. The tube comprises a filter disposed between the first and second ends for blocking passage of said particles upon a flow of the fluid sample therethrough to thereby trapping said particles in a trapping zone defined upstream said filter.
The method further includes (b) passing the fluid sample from the first end to the second end thereby trapping the particles in said trapping zone.
The method further includes (c) passing the fluid sample through a volume indicator or receiving the fluid sample in a volume indicator, said volume indicator is configured to provide indication of the volume of the fluid sample passing through said sampling tube.
In some embodiments of the method, (c) is carried out prior to (b), in some embodiments (c) is carried out after (b) and in some other embodiments, (c) is carried out simultaneously with (b).
In some embodiments, the volume indicator is a flowmeter disposed along the flow path of the fluid sample in the sample collection device.
In some embodiments of the method, the volume indicator is a deformable reservoir capable of changing its volume between at least a first and second volumes, and wherein one of the first and second ends are fluid-tight coupled to the deformable reservoir such that upon a flow of the fluid that causes or resulting in said change of volume of the deformable reservoir, said particles are being trapped in said trapping zone.
In some embodiments of the method, the sample collection device comprises a sealing member and the method further comprising fluid-tight sealing the volume of the trapping zone.
In some embodiments of the method, the sealing member is configured to seal the first end of the sampling tube.
In some embodiments of the method, the sample collection device comprises a unidirectional valve disposed at a flow path between said fluid inlet and said filter for allowing introduction of fluid sample into the sampling tube and blocking discharge of fluid sample from the sampling tube towards or via the fluid inlet.
In some embodiments of the method, the volume indicator is a deformable reservoir capable of changing its volume between at least a first and second volumes, and wherein one of the first and second ends are fluid-tight coupled to the deformable reservoir such that upon a flow of the fluid that causes or resulting in said change of volume of the deformable reservoir, said particles are being trapped in said trapping zone.
In some embodiments of the method, the deformable reservoir is fluid-tight coupled to the second end and the fluid inlet disposed at or upstream said first end of the sampling tube, said second volume being larger than the first volume.
In some embodiments of the method, the first end being fluid-tight coupled to the deformable reservoir and the fluid inlet is formed in or disposed upstream the deformable reservoir, the device further includes a closure configured for association with the second end in two states: a first state for fluidically sealing the second and a second state for allowing flow of fluid through the second end. The deformable reservoir comprises a deformable reservoir inlet for receiving fluid being introduced via said fluid inlet when the closure is at the first state, according to (a). The method further comprising sealing the fluid inlet after (a), switching the closure to the second state and thereafter pressing the deformable reservoir to carry out (b) and (c).
In some embodiments of the method, the volume indicator is a deformable reservoir capable of changing its volume between at least a first and second volumes. The deformable reservoir comprises a deformable reservoir inlet for receiving fluid being introduced via said fluid inlet, according to (a). The method further comprising sealing said deformable reservoir inlet after filling the deformable reservoir with fluid sample to said first volume, fluidically connecting the deformable reservoir inlet to the first end and releasing the fluid sample from the reservoir towards the sampling tube to decrease the volume of the deformable reservoir to the second volume, resulting in a flow of fluid through said sampling tube, thereby causing or forcing said particles for being trapped in said trapping zone.
In some embodiments, the method further comprising introducing the deformable reservoir into the tube and fluid-tight sealing the first end of the sampling tube thereafter with a sealing member.
In some embodiments of the method, the deformable reservoir comprises walls that at least portion thereof is flexible or deformable.
In some embodiments of the method, the inlet is a mouthpiece.
In some embodiments of the method, the reservoir is inflatable and/or compressible.
In some embodiments of the method, the reservoir includes a piston.
In some embodiments of the method, the filter is a microbial filter selected from bacterial and viral filter. In some embodiments, the filter is configured to filter-out particles having a diameter of at least 75 nm, 90 nm or 100 nm, such as SARS-COV-2 viruses.
In some embodiments, the method further includes sealing the second end of the sampling tube.
In some embodiments of the method, the sample collection device is any one of the above described embodiments, or any combination thereof.
In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:
The present disclosure provides a sample collection device that is configured to receive a large volume of a fluid sample containing particles of interest, e.g. microbes, viruses, pathogens, contaminations, etc., and extract therefrom a concentrated portion having a volumetric concentration of particles above the analysis threshold. The concentrated portion is a smaller volume of fluid than the entire fluid sample and contains higher volumetric concentration of particles of interest than originally found in the fluid sample. The volume of the concentrated portion vs the volume of the entire fluid sample gives the increase factor and serves to derive the original concentration of the particles in the original sample. For example, if the sample is received from an exhale of a subject, the device output of the sample is the volume of the trapping zone that contains a concentrated sample volume that is smaller than the entire air volume that the subject introduced into the device. By trapping the particles of interest in the trapping zone, e.g. by using a selective filter for filtering the desired particles (for example, according to their size), this concentrated portion includes higher density of volumetric concentration than the original sample volume, which facilitates to apply analysis on the concentrated portion. The exhaled air volume into the device may be, for example, 1 liter and the volume of the trapping zone may be 1 ml such that the increase factor is 1000. This means that the output of the sample collection device yields a particle volumetric concentration 1000 folds higher than the original fluid sample.
Reference is first made to
Upon introduction of fluid FL through the inlet 102, the deformable reservoir is inflated, due to its flexible walls 115, as can be seen in
The removable closure 113 that fits in the second end 110 seals the device such that the fluid within the reservoir 104 remains therein as long as the closure remains plugged in the second end 110, as can be seen in
The inlet sealing member 116 is configured to fit in the first end 108 together with the deflated reservoir 104 such that the trapping zone 114 is confined between the first end 108 and the filter 112, and more specifically between the inlet sealing member 116 and the filter 112. As can be seen in
In the figures throughout the application, like elements of different figures were given similar reference numerals shifted by the number of hundreds corresponding to the number of the respective figure. For example, element 202 in
Another embodiment of the device of the present disclosure is exemplified in
After the inlet sealing member 216 is plugged to the fluid inlet 202, the closure 213 is removed from the second end 210 of the tube 206. By compressing the reservoir 204 with application of force F, the volume of the reservoir decreases to a second volume while fluid drains through the second inlet 210, as can be best seen in
The rate between the initial volume of the reservoir 204 and the final volume of the trapping zone 214 serves for calculating the increase factor and deriving the real concentration of particles in the original sample.
The reservoir 304 is inflated by a desired amount of fluid that can be measurable by a flow meter or by a degree of inflation of the reservoir 304. The rate between the amount of fluid that is introduced into the reservoir and the eventual volume of fluid in the trapping zone 314 serves for calculating the increase factor and deriving the real concentration of particles in the original sample.
Reference is now made to
The fluid sample FS passes through the tube 632, from the firs end 608 towards the second end 610 and is discharged out of the device through the second end 610 of the tube 606, e.g. to a sterilization device, waste enclosed reservoir, or the environment.
Reference is now made to
A flowmeter 432 is disposed downstream the filter 412 and is configured to measure the amount of fluid (e.g. the volumetric volume) that passes through the tube 406. The flowmeter 432 allows the user to easily determine the amount of total sample fluid that passes through the tube 406 during a sampling session. By measuring the amount of fluid in a sampling session, the original volumetric concentration of the original sample can be derived by determining the volumetric concentration in the trapping zone. It is to be noted that the flowmeter may be disposed at any location along the flow path of the fluid in the tube and its position in
After the fluid sample FS passes through the flowmeter 432, it is discharged through the second end 410 of the tube 406 to the environment.
| Number | Date | Country | Kind |
|---|---|---|---|
| 276367 | Jul 2020 | IL | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IL2021/050919 | 7/29/2021 | WO |
