FILTRATION SAMPLING DEVICES
20230152192 ยท 2023-05-18
Assignee
Inventors
- Zvi FELDMAN (Sde Zvi, IL)
- Robert Eric Levitz (Beit Shemesh, IL)
- Rinat Adi (Holon, IL)
- Zeev Fleishman (Yod Aleph, IL)
Cpc classification
G01N1/4077
PHYSICS
International classification
Abstract
A sampling device is provided for concentrating a liquid specimen sample, including a filtration assembly, which includes a tubular container and a plunger. The plunger includes a plunger head and a plunger rod that is shaped so as to define an internal plunger space having a plunger-space proximal opening through a proximal end of the plunger rod. The sampling device is configured such that a filter is removable from the tubular container via the plunger-space proximal opening while the plunger head is within the tubular container. Other embodiments are also described.
Claims
1. A sampling device for concentrating a liquid specimen sample, the sampling device comprising: a filtration assembly, which comprises: (i) a tubular container, which is shaped so as to define an inner wall and a proximal container opening for receiving the liquid specimen sample; (ii) a plunger, which (A) comprises a plunger head and a plunger rod, which (1) has a distal end portion to which the plunger head is coupled, and (2) is shaped so as to define an internal plunger space having a plunger-space proximal opening through a proximal end of the plunger rod, and (B) is insertable into the tubular container via the proximal container opening, such that a lateral surface of the plunger head forms a fluid-tight movable seal with the inner wall; and (iii) a filter, wherein the filtration assembly is configured such that movement of the plunger head within the tubular container, when the liquid specimen sample is contained in the tubular container and the filter is disposed in the tubular container, pushes at least a portion of the liquid specimen sample through the filter, and wherein the sampling device is configured such that the filter is removable from the tubular container via the plunger-space proximal opening while the plunger head is within the tubular container.
2. The sampling device according to claim 1, wherein the plunger head is shaped so as to define a plunger-head opening through the plunger head and into the internal plunger space, wherein the sampling device comprises a filter-withdrawal shaft, which (a) includes a distal portion that is directly or indirectly coupled to the filter, and (b) which is disposed passing through the internal plunger space, and wherein the sampling device is configured such that proximal withdrawal of the filter-withdrawal shaft out of the internal plunger space, while the plunger head is within the tubular container, pulls the filter into the internal plunger space via the plunger-head opening and out of the internal plunger space via the plunger-space proximal opening, and removes the filter-withdrawal shaft and the filter from the filtration assembly.
3-15. (canceled)
16. The sampling device according to claim 2, wherein the plunger rod is shaped so as to define therewithin a waste liquid receptacle, wherein the plunger head is shaped so as to define a filter support, which is shaped so as to define (a) a distal support surface, (b) a plurality of filtrate-passage openings through the filter support into the waste liquid receptacle, and (c) the plunger-head opening, wherein the filter is disposed on the distal support surface, and wherein the filtration assembly is configured such that movement of the plunger head within the tubular container, when the liquid specimen sample is contained in the tubular container and the filter is disposed in the tubular container, pushes at least a portion of the liquid specimen sample through the filter and the filtrate-passage openings and into the waste liquid receptacle.
17. The sampling device according to claim 2, wherein the plunger-space proximal opening and a longitudinal portion of the filter-withdrawal shaft are shaped so as to define corresponding female and male screw threads, respectively, which (a) removably couple the filter-withdrawal shaft to the plunger rod while the filter-withdrawal shaft is disposed passing through the internal plunger space, and (b) prevent the premature proximal withdrawal of the filter-withdrawal shaft out of the internal plunger space, and wherein the sampling device is configured such that rotation of the filter-withdrawal shaft and the plunger-space proximal opening with respect to each other (a) causes an initial portion of the proximal withdrawal of the filter-withdrawal shaft out of the internal plunger space, and (b) decouples the female and the male screw threads from each other.
18-41. (canceled)
42. A testing kit comprising the sampling device according to claim 1, the testing kit further comprising a lateral flow immunoassay test strip, which is configured to detect the presence of a biological particulate trapped by the filter.
43. The testing kit according to claim 42, further comprising reagents for use with the lateral flow immunoassay test strip.
44. The testing kit according to claim 42, wherein the biological particulate is selected from the group consisting of: a virus, a bacterium, a microorganism, a fungus, a spore, a mite, a biological cell, a biological antigen, a protein, a protein antigen, and a carbohydrate antigen.
45. A method for concentrating a liquid specimen sample, the method comprising: placing the liquid specimen sample in a tubular container of a filtration assembly of a sampling device; inserting a plunger head of a plunger of the filtration assembly into the tubular container via a proximal container opening of the tubular container, such that a lateral surface of the plunger head forms a fluid-tight movable seal with an inner wall of the tubular container, wherein the plunger includes a plunger rod that (a) has a distal end portion to which the plunger head is coupled, and (b) is shaped so as to define an internal plunger space having a plunger-space proximal opening through a proximal end of the plunger rod; distally advancing the plunger head within the tubular container to drive at least a portion of the liquid specimen sample through a filter disposed in the tubular container; and removing the filter from the tubular container via the plunger-space proximal opening while the plunger head is within the tubular container.
46. The method according to claim 45, wherein the plunger head is shaped so as to define a plunger-head opening through the plunger head and into the internal plunger space, wherein the sampling device includes a filter-withdrawal shaft, which (a) includes a distal portion that is directly or indirectly coupled to the filter, and (b) is disposed passing through the internal plunger space, and wherein removing the filter from the tubular container comprises proximally withdrawing the filter-withdrawal shaft out of the internal plunger space, while the plunger head is within the tubular container, so as to pull the filter into the internal plunger space via the plunger-head opening and out of the internal plunger space via the plunger-space proximal opening, and to remove the filter-withdrawal shaft and the filter from the filtration assembly.
47-59. (canceled)
60. The method according to claim 46, wherein the plunger rod is shaped so as to define therewithin a waste liquid receptacle, wherein the plunger head is shaped so as to define a filter support, which is shaped so as to define (a) a distal support surface, (b) a plurality of filtrate-passage openings through the filter support into the waste liquid receptacle, and (c) the plunger-head opening, wherein the filter is disposed on the distal support surface, and wherein distally advancing the plunger head within the tubular container, when the liquid specimen sample is contained in the tubular container and the filter is disposed in the tubular container, pushes at least a portion of the liquid specimen sample through the filter and the filtrate-passage openings and into the waste liquid receptacle.
61. The method according to claim 46, wherein the plunger-space proximal opening and a longitudinal portion of the filter-withdrawal shaft are shaped so as to define corresponding female and male screw threads, respectively, which (a) removably couple the filter-withdrawal shaft to the plunger rod while the filter-withdrawal shaft is disposed passing through the internal plunger space, and (b) prevent the premature proximal withdrawal of the filter-withdrawal shaft out of the internal plunger space, and wherein proximally withdrawing the filter-withdrawal shaft out of the internal plunger space comprises rotating the filter-withdrawal shaft and the plunger-space proximal opening with respect to each other so as to (a) cause an initial portion of the proximal withdrawal of the filter-withdrawal shaft out of the internal plunger space, and (b) decouple the female and the male screw threads from each other.
62-88. (canceled)
89. The method according to claim 45, further comprising, after the filter has been removed from the tubular container, detecting the presence of a biological particulate trapped by the filter.
90. The method according to claim 89, wherein detecting the presence of the biological particulate trapped by the filter comprising using a lateral flow immunoassay test strip to detect the presence of the biological particulate trapped by the filter.
91. The method according to claim 89, wherein the biological particulate is selected from the group consisting of: a virus, a bacterium, a microorganism, a fungus, a spore, a mite, a biological cell, a biological antigen, a protein, a protein antigen, and a carbohydrate antigen.
92-357. (canceled)
358. The method according to claim 45, wherein the sampling device is configured to bunch up at least a portion of the filter during removal of the filter from the tubular container via the plunger-space proximal opening while the plunger head is within the tubular container.
359. The method according to claim 358, wherein the sampling device is configured to bunch up the at least a portion of the filter into a flower-like arrangement during the removal of the filter from the tubular container via the plunger-space proximal opening while the plunger head is within the tubular container.
360. The method according to claim 45, wherein the plunger is shaped so as to define a cylindrical filter support, which (a) surrounds and extends alongside at least a portion of the plunger rod, separated from the plunger rod to provide a space for insertion of the tubular container, and (b) is shaped so as to define a first thread that faces radially inward, wherein an external surface of the tubular container is shaped so as to define a second thread that faces radially outward, and wherein inserting the plunger head into the tubular container and distally advancing the plunger head within the tubular container comprises threadingly coupling the first thread to the second thread and rotating the plunger with respect to the tubular container.
361. The method according to claim 45, wherein the plunger rod is shaped so as to define therewithin a waste liquid receptacle, wherein the plunger head is shaped so as to define a filter support, which is shaped so as to define (a) a distal support surface, (b) a plurality of filtrate-passage openings through the filter support into the waste liquid receptacle, and (c) a plunger-head opening through the plunger head and into the internal plunger space, wherein the filter is disposed on the distal support surface, and wherein distally advancing the plunger head within the tubular container, when the liquid specimen sample is contained in the tubular container and the filter is disposed in the tubular container, pushes at least a portion of the liquid specimen sample through the filter and the filtrate-passage openings and into the waste liquid receptacle.
362. The method according to claim 45, wherein the filtration assembly further includes: a filter support, which is disposed within the tubular container, and which is shaped so as to define (a) a proximal support surface on which the filter is disposed, (b) a plurality of filtrate-passage openings through the filter support, and (c) a filter-support shaft-passage region; a shaft having a proximal portion having a non-circular shape; and a waste liquid receptacle for receiving a filtrate, wherein the plunger head, the filter support, and the shaft are configured such that a proximal portion of the shaft is axially movable through the filter-support shaft-passage region, and wherein distally advancing the plunger head within the tubular container comprises: distally advancing the plunger within the tubular container, when (a) the liquid specimen sample is contained in the tubular container and the filter is disposed on the proximal support surface in the tubular container and (b) the filter support and the shaft are locked to each other, do push the at least a portion of the liquid specimen sample through the filter and the filtrate-passage openings and into the waste liquid receptacle, without pushing the filter support distally within the tubular container; thereafter, rotating, by a user, the filter support with respect to the shaft to align the non-circular shape of the proximal portion of the shaft with a corresponding shape of the filter-support shaft-passage region, thereby unlocking the filter support and the shaft from each other; and thereafter, further distally advancing the plunger head to push the filter support distally within the tubular container.
363. The method according to claim 61, wherein the female and the male screw threads together provide first threading between the plunger-space proximal opening and the filter-withdrawal shaft, wherein inserting the plunger head into the tubular container and distally advancing the plunger head within the tubular container comprises threadingly coupling the plunger to an external surface of the tubular container by second threading and rotating the plunger with respect to the tubular container, and wherein the first threading and the second threading have opposite handedness.
364. The method according to claim 90, wherein detecting the presence of the biological particulate trapped by the filter comprises: inserting the filter into an extraction tube and bathing the filter in reagents; and thereafter using the lateral flow immunoassay test strip to detect the presence of the biological particulate trapped by the filter.
365. The sampling device according to claim 1, wherein the sampling device is configured to bunch up at least a portion of the filter during removal of the filter from the tubular container via the plunger-space proximal opening while the plunger head is within the tubular container.
366. The sampling device according to claim 365, wherein the sampling device is configured to bunch up the at least a portion of the filter into a flower-like arrangement during the removal of the filter from the tubular container via the plunger-space proximal opening while the plunger head is within the tubular container.
367. The sampling device according to claim 1, wherein the plunger is shaped so as to define a cylindrical filter support, which (a) surrounds and extends alongside at least a portion of the plunger rod, separated from the plunger rod to provide a space for insertion of the tubular container, and (b) is shaped so as to define a first thread that faces radially inward, wherein an external surface of the tubular container is shaped so as to define a second thread that faces radially outward, and wherein the first and the second threads are configured to engage each other.
368. The sampling device according to claim 1, wherein the plunger rod is shaped so as to define therewithin a waste liquid receptacle, wherein the plunger head is shaped so as to define a filter support, which is shaped so as to define (a) a distal support surface, (b) a plurality of filtrate-passage openings through the filter support into the waste liquid receptacle, and (c) a plunger-head opening through the plunger head and into the internal plunger space, wherein the filter is disposed on the distal support surface, and wherein the filtration assembly is configured such that movement of the plunger head within the tubular container, when the liquid specimen sample is contained in the tubular container and the filter is disposed in the tubular container, pushes at least a portion of the liquid specimen sample through the filter and the filtrate-passage openings and into the waste liquid receptacle.
369. The sampling device according to claim 1, wherein the filtration assembly further comprises: a filter support, which is disposed within the tubular container, and which is shaped so as to define (a) a proximal support surface on which the filter is disposed, (b) a plurality of filtrate-passage openings through the filter support, and (c) a filter-support shaft-passage region; a shaft having a proximal portion having a non-circular shape; and a waste liquid receptacle for receiving a filtrate, wherein the plunger head, the filter support, and the shaft are configured such that a proximal portion of the shaft is axially movable through the filter-support shaft-passage region, wherein the filtration assembly is configured such that first distal advancement of the plunger within the tubular container, when (a) the liquid specimen sample is contained in the tubular container and the filter is disposed on the proximal support surface in the tubular container and (b) the filter support and the shaft are locked to each other, pushes the at least a portion of the liquid specimen sample through the filter and the filtrate-passage openings and into the waste liquid receptacle, without pushing the filter support distally within the tubular container, wherein the filter support and the shaft are releasably axially locked with respect to each other, and the sampling device is configured such that rotation, by a user, of the filter support with respect to the shaft aligns the non-circular shape of the proximal portion of the shaft with a corresponding shape of the filter-support shaft-passage region, thereby unlocking the filter support and the shaft from each other, and wherein the filtration assembly is configured such that after the first distal advancement of the plunger within the tubular container when the filter support and the shaft are unlocked from each other, further second distal advancement of the plunger head pushes the filter support distally within the tubular container.
370. The sampling device according to claim 17, wherein the female and the male screw threads together provide first threading between the plunger-space proximal opening and the filter-withdrawal shaft, wherein the plunger and an external surface of the tubular container are threadingly couplable to each other by second threading, and wherein the first threading and the second threading have opposite handedness.
371. The testing kit according to claim 43, further comprising an extraction tube, into which the filter is insertable for bathing in the reagents.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF APPLICATIONS
[0709] In some embodiments of the present invention, a sampling device 20 is provided for concentrating a liquid specimen sample 22.
[0710] Reference is made to
[0711] Reference is also made to
[0712] Reference is further made to
[0713] Reference is still further made to
[0714] Reference is still further made to
[0715] Reference is still further made to
[0716] Reference is additionally made to
[0717] Reference is yet additionally made to
[0718] Reference is also made to
[0719] Reference is further made to
[0720] All references herein to sampling device 20 are to be understood as referring to sampling devices 120, 220, and 320, and like parts have like reference numerals.
[0721] Sampling device 20 comprises a filtration assembly 24 and collection vial 50. Filtration assembly 24 comprises a tubular container 30 and plunger 40. Tubular container 30 is shaped so as to define a proximal container opening 32 for receiving liquid specimen sample 22. Optionally, proximal container opening 32 has a conical or funnel shape to facilitate receipt of liquid specimen sample 22, which may, for example, be expressed (e.g., spit) from subject's mouth into tubular container 30, or transferred to tubular container 30 from a collection container. Optionally, the funnel shape of proximal container opening 32 is similar to funnel-shaped proximal opening 36 shown in FIG. 1 of US Patent Application Publication 2019/0381498 to Fruchter et al., which is incorporated herein by reference. Tubular container may be cylindrical, as shown, or may alternatively have another, non-circular cross-sectional shape. Alternatively or additionally, tubular container 30 may have different cross-sectional shapes along respective different longitudinal portions of the tubular container; optionally, one or more of the cross-sectional shapes is circular. Tubular container 30 is also shaped so as to define an inner wall 34. At least a portion of tubular container 30, such as a proximal portion, may define a syringe barrel.
[0722] Typically, tubular container 30 has an internal volume of at least 0.5 ml (e.g., at least 1 ml, such as at least 5 ml), no more than 500 ml (e.g., no more than 70 ml), and/or between 0.5 ml (e.g., 1 ml or 5 ml) and 500 ml (e.g., 70 ml).
[0723] For some applications, tubular container 30 does not comprise a Luer lock or any other type of needle-coupling mechanism.
[0724] For some applications, collection vial 50 has a volume of at least 1 ml, no more than 50 ml, and/or between 1 and 50 ml, such as at least 2 ml, no more than 20 ml, and/or between 2 and 20 ml, e.g., at least 3 ml (e.g., at least 5 ml), no more than 15 ml, and/or between 3 (e.g., 5) and 15 ml. For some applications, collection vial 50 has a greatest internal diameter of no more than 35 mm, e.g., no more than 20 mm, such as no more than 15 mm or no more than 10 mm.
[0725] Collection vial 50 is typically shaped so as to define a vial opening 52.
[0726] For some applications, collection vial 50 is tapered toward an end 89 of collection vial 50 opposite an end 91 of collection vial 50 that defines vial opening 52 (labeled in
[0727] Collection vial 50 has a greatest outer diameter D1 (labeled in
[0728] Plunger 40 comprises a plunger head 42, which is shaped so as to define a plunger-head opening 44 through plunger head 42. Plunger 40 is insertable into tubular container 30 via proximal container opening 32, such that a lateral surface 46 of plunger head 42 (labeled in
[0729] For some applications, such as shown in
[0730] For some applications, a cross-sectional area of plunger-head opening 44 is at 20%, no more than 90%, and/or between 20% and 90% of a cross-sectional area of a distal surface of plunger head 42 (the cross-sectional area of the distal surface including the cross-sectional area of plunger-head opening 44).
[0731] When sampling device 20 is in its initial state (which is typically set during manufacture thereof), as shown in
[0732] Typically, filtration assembly 24 further comprises a filter 60. Filter 60 is configured to concentrate at least a portion of liquid specimen sample 22 onto filter 60, while allowing a filtrate 61 to pass through filter 60. Typically, distal advancement of plunger 40 within tubular container 30 applies pressure to drive (e.g., push) at least a portion of liquid specimen sample 22 contained in tubular container 30 through filter 60, such as shown in the transitions between
[0733] Filter 60 comprises synthetic or natural materials formed, for example, as a matrix, membrane, fabric, beads, or other configuration. For some applications, filter 60 comprises a mechanical filter, which is configured to mechanically filter particulate from liquid specimen sample 22 by size-based filtration. Optionally, filter 60 comprises a depth filter.
[0734] Alternatively or additionally, for some applications, filter 60 comprises fixed antibodies configured to capture the particulate (e.g., free viral particles) by affinity-based filtration.
[0735] For some applications, for example, when filter 60 is used for capturing free virus, virions, or viral particles by size-based filtration, filter 60 may have a pore size of between 0.01 and 0.3 microns and/or a molecular weight cut off of between 10 kDa and 500 kDa.
[0736] For some applications, filter 60 has a pore size of between 0.2 and 2.0 microns, for example, when filter 60 is used for capturing bacteria by size-based filtration.
[0737] For other applications, filter 60 has a nominal pore size of between 30 microns and 1.5 mm, the nominal pore size representative of a minimum size of spherical particles necessary for the filter to retain 85% of the spherical particles when H2O containing the spherical particles is passed through the filter at 20 degrees C. under pressure supplied by a 10 cm water column. For these applications, filter 60 may implement techniques described in U.S. Provisional Application 63/117,294, filed Nov. 23, 2020, is assigned to the assignee of the present application and incorporated herein by reference.
[0738] For example, the nominal pore size may be at least 40 microns, such as at least 60 microns, e.g., at least 100 microns, at least 120 microns, at least 150 microns, at least 200 microns, or at least 500 microns. Alternatively or additionally, for example, the nominal pore size may be less than 1 mm, such as less than 750 microns, less than 500 microns, or less than 250 microns.
[0739] For some applications, filtration assembly 24 comprises a plurality of filters, such as described hereinbelow with reference to
[0740] Typically, filtration assembly 24 further comprises a waste liquid receptacle 56 for receiving filtrate 61. For some applications, a distal portion of tubular container 30 is shaped so as to define waste liquid receptacle 56, such as shown in the drawings. For other applications, waste liquid receptacle 56 is provided as a separate container coupled in fluid communication with tubular container 30 downstream (distally) to filter 60 (configuration not shown).
[0741] Optionally, waste liquid receptacle 56 is shaped so as to define an opening 58 through an external wall of waste liquid receptacle 56 to release displaced air. For example, opening 58 may be located on a side portion of the external wall, typically above the highest level that filtrate 61 is expected to reach during ordinary use of the device. For some applications, waste liquid receptacle 56 comprises an air filter (e.g., an N98 filter) that is disposed to filter air that passes out of waste liquid receptacle 56 through opening 58 (not shown). Alternatively or additionally, for some applications, waste liquid receptacle 56 comprises a one-way pressure-sensitive valve disposed in opening 58.
[0742] For some applications, waste liquid receptacle 56 contains a disinfectant or a liquid-absorbing material.
[0743] Reference is made to
[0744] Reference is again made to
[0745] For some applications, sampling device 20 is configured such that filter 60 is advanceable into collection vial 50 via vial opening 52 while collection vial 50 is disengageably coupled to filtration assembly 24.
[0746] For some applications, filtration assembly 24 is configured such that movement (such as distal advancement) of plunger head 42 and collection vial 50 within tubular container 30 advances filter 60 into (such as entirely into) collection vial 50 via plunger-head opening 44 and vial opening 52, for example, such as described hereinbelow with reference to
[0747] Reference is made to
[0748] Reference is made to
[0749] Frangible seal 276 may be coupled to plunger-head opening 44 (such as shown), plunger head 42 (configuration not shown), vial opening 52 (configuration not shown), another element disposed between plunger-head opening 44 and vial opening 52 (configuration not shown), or a combination of these locations.
[0750] For example, frangible seal 276 may comprise a pliable material (such as silicone) that is easily torn or a rigid material that is easily broken (e.g., shaped so as define slits to aid in breaking).
[0751] Reference is again made to
[0754] Filter 60 is disposed on proximal support surface 64.
[0755] For some of these applications, filter support 62 is shaped so as to further define a filter-support shaft-passage region 69, which, for some applications, is shaped so as to define a filter-support opening 70 through filter support 62. For these applications, filtration assembly 24 further comprises a shaft 72. Plunger head 42, filter support 62, and shaft 72 are configured such that a proximal portion 74 of shaft 72 (labeled in
[0756] For other applications, such as shown in
[0757] For some applications, filter-support shaft-passage region 69 is integral with other portions (e.g., other more peripheral portions) of filter support 62 and is thinner than the other portions of filter support 62 (such as shown). Alternatively, for some applications, filter-support shaft-passage region 69 comprises a frangible membrane (configuration not shown).
[0758] Reference is again made to
[0759] Typically, a cross-sectional area of filter-support shaft-passage region 69 (e.g., filter-support opening 70) is substantially larger than an average cross-sectional area of filtrate-passage openings 68; for example, the cross-sectional area of filter-support shaft-passage region 69 (e.g., filter-support opening 70) may be at least 10 times, such as at least 25 times, the average cross-sectional area of filtrate-passage openings 68.
[0760] For some applications: [0761] the cross-sectional area of filter-support shaft-passage region 69 (e.g., filter-support opening 70) is between 20 and 75 mm2, [0762] the average cross-sectional area of filtrate-passage openings 68 is between 0.5 and 1.5 mm2, [0763] the cross-sectional area of filter-support shaft-passage region 69 (e.g., filter-support opening 70) is between 2.5% and 20% of a cross-sectional area of proximal support surface 64 of filter support 62.
[0764] For some of these applications, proximal portion 74 of shaft 72, filter-support shaft-passage region 69 (e.g., filter-support opening 70), plunger-head opening 44, and vial opening 52 are coaxial. Alternatively or additionally, for some of these applications, proximal portion 74 of shaft 72, filter-support shaft-passage region 69 (e.g., filter-support opening 70), plunger-head opening 44, and vial opening 52 are coaxial with or parallel to central longitudinal axis 66 of tubular container 30.
[0765] For some applications, a cross-sectional area of proximal portion 74 of shaft 72 is between 80% and 110% of a cross-sectional area of filter-support shaft-passage region 69 (e.g., filter-support opening 70).
[0766] For some of these applications in which filter-support shaft-passage region 69 is shaped so as to define filter-support opening 70, when sampling device 20 is in its initial state (which is typically set during manufacture thereof), as shown in
[0771] For some applications, such as shown, for example, in
[0772] For some of these applications, sampling device 20 is configured such that the movement of plunger head 42 and collection vial 50 within tubular container 30 advances filter 60 into collection vial 50 via plunger-head opening 44 and vial opening 52 while filter 60 remains stationary with respect to a distal end of tubular container 30, such as shown in
[0773] Alternatively or additionally, proximal withdrawal of plunger 40 within and/or out of tubular container 30, or a combination of distal advancement and proximal withdrawal of plunger 40, advances filter 60 into (typically entirely into) collection vial 50 via plunger-head opening 44 and vial opening 52 (configurations not shown).
[0774] For some applications in which sampling device 20 is configured such that movement of plunger head 42 and collection vial 50 within tubular container 30 advances filter 60 into collection vial 50, relative axial movement between shaft 72 and collection vial 50 causes proximal portion 74 of shaft 72 to push filter 60 into collection vial 50 via vial opening 52, such as shown in
[0775] As mentioned above, typically first distal advancement of plunger 40 within tubular container 30 applies pressure to drive (e.g., push) at least a portion of liquid specimen sample 22 contained in tubular container 30 through filter 60, without pushing filter support 62 distally within tubular container 30, such as shown in the transitions between
[0776] As a result of this relative axial movement between shaft 72 and collection vial 50, proximal portion 74 of shaft 72 axially moves through filter-support shaft-passage region 69 (e.g., filter-support opening 70), plunger-head opening 44, and vial opening 52, into collection vial 50, as shown in
[0777] In these applications, a lateral surface 63 (labeled in
[0778] For some applications, sampling device 20 is configured such that the further second distal advancement of plunger head 42, described hereinabove with reference to
[0779] For some applications, filter support 62 and shaft 72 are releasably coupled to each other such that: [0780] the first distal advancement of plunger head 42 within tubular container 30, described hereinabove with reference to the transitions between
[0782] For example, such as shown in
[0783] For example, frangible portions 73 may be shaped as a plurality of tabs distributed around the perimeter of proximal portion 74 of shaft 72. Optionally, proximal portion 74 of shaft 72, filter-support opening 70, and the tabs are shaped so as to define a plurality of narrow spaces between proximal portion 74 of shaft 72 and the perimeter of filter-support opening 70; these narrow spaces may serve to allow passage of liquid specimen sample 22 through filter support 62, and thus serve the same function as filtrate-passage openings 68.
[0784] For some applications, sampling device 20 is configured such that the further second distal advancement of plunger head 42, described hereinabove with reference to
[0785] For other applications, filter support 62 and shaft 72 are releasably axially locked with respect to each other, and sampling device 20 is configured such that a filter-support release action by a user unlocks filter support 62 and shaft 72 from each other. For example, proximal portion 74 of shaft 72 may have a non-circular shape (e.g., a triangular shape), and the filter-support release action is rotation, by the user, of filter support 62 with respect to shaft 72, in order to align the shape of proximal portion 74 of shaft 72 with a corresponding shape of filter-support shaft-passage region 69 (e.g., filter-support opening 70).
[0786] For some applications, such as shown in
[0787] For some applications, such as shown in
[0788] For some applications in which plunger 40 comprises plunger rod 82, plunger rod 82 is shaped so as to define an internal plunger space 86 (labeled in
[0789] For some applications, the sampling device is configured such that collection vial 50 is removable from internal plunger space 86 through plunger-space proximal opening 90, optionally while plunger head 42 is within tubular container 30 (collection vial 50 is also removable from internal plunger space 86 through plunger-space proximal opening 90 if plunger head 42 has been removed from tubular container 30).
[0790] Alternatively or additionally, the sampling device is configured such that filter 60 is removable from tubular container 30 (and from filtration assembly 24) via plunger-space proximal opening 90, optionally while plunger head 42 is within tubular container 30. In some configurations, such as described with reference to
[0791] For some applications, collection vial 50 is disengageably coupled axially with respect to plunger 40, such as shown in
[0792] Collection vial 50 is configured to become disengaged from plunger 40 in order to allow collection vial 50 to be removed from plunger 40 (such as from internal plunger space 86 through plunger-space proximal opening 90), such as shown in
[0793] For applications in which pushing on axial portion 87 of collection vial 50 distally advances plunger head 42 while plunger rod 82 remains stationary with respect to tubular container 30, such as described hereinbelow and shown in
[0794] Optionally, the one or more couplers 154, upon becoming fully disengaged from collection vial 50 and the internal surface of internal plunger space 186, fall out of internal plunger space 186, typically into tubular container 30, such as shown in
[0795] For other applications, such as shown in
[0796] Typically, the one or more couplers 354 are disengageably coupled to the external surface of collection vial 50 at least partially by friction, and, optionally, additionally by slight penetration of respective sharp portions of the one or more couplers 354 into the external surface of collection vial 50.
[0797] For some applications, such as shown in the transition between
[0798] For some applications, the one or more couplers 354 are configured to continue to engage collection vial 50 even after the one or more couplers entirely disengage from plunger rod 382, such as shown in
[0799] For some applications in which the one or more couplers 354 comprise two or more couplers 354 (e.g., exactly two couplers 354, as shown), sampling device 320 further comprises a proximal grip 392. The two or more couplers 354 are fixed to and extend distally from proximal grip 392.
[0800] For some applications, such as shown in
[0801] For some applications, an external surface of plunger rod 382 is shaped so as to define a plurality of protrusions 396 arranged along plunger rod 382, which are configured to engage inner wall 34 of tubular container 30. Protrusions 396 may slow down distal advancement of plunger rod 382 in tubular container 30, such as to provide uniform speed of advancement and controlled buildup of pressure and filtration in tubular container 30, which may aid in calibration of sampling device 320 during manufacture. Alternatively or additionally, protrusions 396 may provide an indication to the user of the speed and/or amount of distal advancement of plunger rod 382 in tubular container 30.
[0802] For some applications, collection vial 50 is disposed alongside plunger rod 82 (configuration not shown).
[0803] For some applications, sterile packaging is provided, in which at least sampling device 20 is removably disposed.
[0804] Reference is again made to
[0809] For some applications, liquid specimen sample 22 is received from a subject's mouth. For some applications, liquid specimen sample 22 comprises gargled fluid, i.e., a gargle fluid that the subject has gargled in his or her mouth and spit out, perhaps along with some saliva. In the present application, including in the claims, โgargled fluidโ means โgargle fluidโ that has been gargled by a subject. Typically, the gargle fluid includes water, carbonated water, saline (e.g., phosphate buffered saline), pelargonium sidoides extract, tannic acid, balloon flower platycodon grandiflorus, berberine sulfate, S-carboxymethylcysteine, curcumin, coloring, flavoring, a detergent (such as Polysorbate 20 (e.g., Tweenยฎ 20)), or any combination thereof. In some applications, the gargle fluid is carbonated. Alternatively or additionally, for some applications, a detergent, such as Polysorbate 20 (e.g., Tweenยฎ 20) is added to the gargled fluid after being gargled by the subject. Alternatively, liquid specimen sample 22 may comprise another type of biological fluid, such as blood (e.g., diluted blood), urine, stool (e.g., diluted stool), gastrointestinal (GI) fluid, or bronchoalveolar lavage fluid.
[0810] Alternatively, liquid specimen sample 22 comprises saliva not swabbed from the throat of a subject (i.e., the saliva was collected without swabbing the subject's throat). (The distinction between โswabโ as a verb and as a noun is noted. A โswabโ (as a noun) may be used to obtain saliva without โswabbingโ (as a verb) the subject's throat. For example, the subject may suck on a swab, or a swab may be dipped in a container into which gargle fluid or saliva has been placed.) By contrast, in commonly-practiced techniques for testing for strep, the tonsils are swabbed. Further alternatively, liquid specimen sample 22 comprises liquid from a cultured medium containing a biological sample which had been incubated within tubular container 30 or incubated separately from the device and then added to tubular container 30.
[0811] Liquid specimen sample 22 (e.g., saliva) may be spit directly by the subject into tubular container 30 or transferred by a healthcare worker from another container into which the subject spit. Alternatively, in the case of saliva, the saliva may be collected from the subject's mouth by having the subject suck on a swab or other absorbent collecting element, such as flocked swabs or cotton rolls.
[0812] For some applications in which the method does not comprise swabbing the throat of the subject, liquid specimen sample 22 is collected by drawing liquid specimen sample 22 out of an oral cavity of the subject via an anterior opening of the oral cavity by contacting one or more portions of the oral cavity with an absorbent material, e.g., a flocked or cotton swab, or a sponge (e.g., at a tip of a collector shaft), without swabbing the oropharynx of the subject. (For example, an ORAcollectยฎ.Math.RNA Saliva Collection Device (DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc. (Bethlehem, Pa., USA)) may be used.) Optionally, the absorbent material is located on a tip of a collector shaft, and liquid specimen sample 22 is drawn out of the oral cavity via the anterior opening of the oral cavity using the absorbent material by inserting the tip of the collector shaft into the oral cavity. For some of these applications, liquid specimen sample 22 is drawn out of the oral cavity via the anterior opening of the oral cavity using the absorbent material by the subject sucking on the absorbent material. For example, the one or more portions of the oral cavity may include one or more of buccal mucosa, the tongue (e.g., under the tongue), the gums (e.g., the lower gums), and/or the palatal mucosa. For example, for swabbing the lower gums, absorbent material (e.g., at a tip of a collector shaft) may be rubbed back and forth along the lower gums several times. (The anterior opening of the oral cavity is the opening of the mouth between the lips, between outside the oral cavity and inside the oral cavity.)
[0813] Alternatively, liquid specimen sample 22 comprises an incubated culture medium containing a biological sample.
[0814] For some applications, filter 60 is advanced into collection vial 50 while filter 60 remains stationary with respect to a distal end of tubular container 30, such as shown in
[0815] For some applications, liquid specimen sample 22 is placed in tubular container 30 proximal to filter 60 that is disposed on proximal support surface 64 defined by filter support 62 that is disposed within tubular container 30, such as shown in
[0816] For some applications, advancing filter 60 into collection vial 50 via plunger-head opening 44 and vial opening 52 comprises axially moving proximal portion 74 of shaft 72 and collection vial 50 with respect to each other, such that (a) proximal portion 74 of shaft 72 moves through (i) filter-support shaft-passage region 69 (e.g., filter-support opening 70) defined by filter support 62, (ii) plunger-head opening 44, and (iii) vial opening 52, and (a) proximal end 75 of shaft 72 pushes filter 60 through plunger-head opening 44 into collection vial 50 via vial opening 52, such as shown in
[0817] For some applications, advancing filter 60 into collection vial 50 via plunger-head opening 44 and vial opening 52 comprises moving plunger head 42 and collection vial 50 within tubular container 30, such as shown in
[0818] For some applications, advancing filter 60 into collection vial 50 via plunger-head opening 44 and vial opening 52 comprises axially moving proximal portion 74 of shaft 72 of filtration assembly 24 and collection vial 50 with respect to each other, such that (a) proximal portion 74 of shaft 72 moves through plunger-head opening 44 and vial opening 52, and (a) proximal end 75 of shaft 72 pushes filter 60 through plunger-head opening 44 into collection vial 50 via vial opening 52, such as shown in
[0819] Reference is made to
[0820] Reference is made to
[0821] Reference is again made to
[0822] For some of these applications, collection vial 50 is decoupled from plunger 40 while plunger head 42 is within tubular container 30, such as shown in
[0823] For some applications, plunger head 42 is inserted into tubular container 30 while collection vial 50 is disposed partially within internal plunger space 86, with axial portion 87 of collection vial 50 protruding proximally out of plunger-space proximal opening 90 of internal plunger space 86. For some of these applications, plunger head 42 is distally advanced within tubular container 30 to drive the at least a portion of liquid specimen sample 22 through filter 60 by pushing on axial portion 87 of collection vial 50.
[0824] For some of these applications in which plunger 40 comprises plunger rod 82 that is shaped so as to define internal plunger space 86, such as described hereinabove, plunger head 42 is inserted into tubular container 30 while collection vial 50 is disposed at least partially within internal plunger space 86, such as shown in
[0825] Reference is made to
[0826] For some of these applications in which plunger 40 comprises plunger rod 82, such as described hereinabove, plunger head 42 is inserted into tubular container 30 while collection vial 50 is disposed alongside plunger rod 82 (configuration not shown). For some applications, filter support 62 is slidable along tubular container 30, and the method further comprises, after distally advancing plunger head 42 within tubular container 30 to drive the at least a portion of liquid specimen sample 22 through filter 60 and filtrate-passage openings 68 of filter support 62 (such as shown in
[0827] For some of these applications, such as shown in
[0828] For some applications in which axial portion 87 of collection vial 50 is used as a handle for plunger 140, such as described above with reference to
[0829] For other applications, such as shown in
[0830] For other applications in which sampling device 320 comprises proximal grip 392, such as described hereinabove with reference to
[0831] For some applications, the method further comprises sealing vial opening 52 with collection vial cap 80 after filter 60 has been advanced into collection vial 50, such as shown in
[0832] For some applications, the method further comprises bathing filter 60 with liquid 1010 within collection vial 50 after filter 60 has been advanced into collection vial 50, such as shown in
[0833] For some applications, the method further comprises, after filter 60 has been advanced into collection vial 50, detecting the presence of a biological particulate trapped by filter 60. For example, the biological particulate may be selected from the group consisting of: a virus, a bacterium, a microorganism, a fungus, a spore, a mite, a biological cell, a biological antigen, a protein, a protein antigen, and a carbohydrate antigen.
[0834] For some applications, detecting the presence of the biological particulate trapped by filter 60 comprising using a lateral flow immunoassay test strip to detect the presence of the biological particulate trapped by filter 60.
[0835] In some applications of the present invention, internal plunger space 86 of plunger rod 82 is shaped so as to define an internal collection chamber, into which filter 60 is advanced (configuration not shown). In these applications, sampling device 20 typically does not comprise collection vial 50 (configuration not shown).
[0836] In some applications of the present invention, collection vial 50 is removable from plunger 40 through plunger-head opening 44 (configuration not shown). For some of these applications, collection vial 50 is removable from internal plunger space 86 through plunger-head opening 44 (configuration not shown).
[0837] In some applications of the present invention, collection vial 50 is fixedly coupled to plunger 40 (configuration not shown).
[0838] In some applications of the present invention, proximal portion 74 of shaft 72 is axially slidable with respect to tubular container 30 (configuration not shown).
[0839] Reference is now made to
[0840] For some applications in which sampling device 20 is configured such that movement of plunger head 42 and collection vial 50 within tubular container 30 advances filter 60 into collection vial 50, such as described hereinabove, relative axial movement between shaft 72 and collection vial 50 causes proximal portion 74 of shaft 72 to push first filter 60A and second filter 60B into collection vial 50 via vial opening 52, such as shown in
[0841] For some applications, first and second filters 60A and 60B have different nominal pore sizes, as defined hereinabove. For these applications, second filter 60B typically has a larger nominal pore size than first filter 60A. For example, when the filters are used for capturing free virus, virions, or viral particles by size-based filtration, first filter 60A may have a pore size of between 0.01 and 0.3 microns and/or a molecular weight cut off of between 10 kDa and 500 kDa, and/or second filter 60B may have a nominal pore size of between 30 microns and 1.5 mm, or the other pore sizes provide for the large-pore filters described in above-mentioned U.S. Provisional Application 63/117,294, filed Nov. 23, 2020.
[0842] For other applications, first filter 60A may have a pore size of between 0.2 and 2.0 microns, for example, when the filters are used for capturing bacteria by size-based filtration.
[0843] For some applications, first filter 60A may comprise a fragile material, such as glass fibers, and second filter 60B may comprise a sturdier material, such as a polymer. Second filter 60B may mechanically support first filter 60A and prevent first filter 60A from breaking apart as proximal portion 74 of shaft 72 pushes the filters into collection vial 50.
[0844] For some of these applications, first and second filters 60A and 60B are coupled together at one or more locations on the filters, such that second filter 60B helps draw first filter 60A into collection vial 50. For example, the filters may be coupled together by gluing (using one or more drops of glue, such as a cyanoacrylate), soldering, overmolding, and/or mechanically connecting interlocking parts. Optionally, one or more filter supports are coupled together with first and second filters 60A and 60B, either between, above, and/or below the filters. Optionally, improving sealing between the perimeter of one or more of the filters with inner wall 34 of tubular container 30 may be achieved by reducing and/or filling spacing between the filter fibers, such as heating and compression, overmolding, and/or filling with adhesive material. For example, for configurations in which at least one of the filters comprises a meltable material, such as a polymer, the filter may be melted around its perimeter (edge) to achieve a better seal with inner wall 34 of tubular container 30.
[0845] For some applications in which second filter 60B comprises a sturdier material, such as a polymer, second filter 60B may be cut, such as in one or more lines. Such cutting may help prevent plugging of collection vial 50 by second filter 60B after insertion thereinto, such as shown in
[0846] Reference is now made to
[0847] Plunger 440 is shaped so as to define first ratchet teeth 493 that face radially inwardly and are configured to engage corresponding second ratchet teeth 495 that are defined by an external surface of tubular container 430 and face radially outward. Plunger 440 and tubular container 430 may respectively comprise one or more sets of first and second ratchet teeth 493 and 495 (for example, two sets, as shown). For some applications, plunger 440 comprises one or more teeth supports 497, which extend proximally alongside at least a portion of plunger rod 482, separated from plunger rod 482 to provide a space for insertion of tubular container 430. The one or more teeth supports 497 are shaped so as to define the one or more sets of first ratchet teeth 493.
[0848] Typically, first and second ratchet teeth 493 and 495 are configured to allow only distal advancement of plunger 440 with respect to tubular container 430 and to prevent proximal withdrawal of the plunger 440 with respect to tubular container 430. This one-way limitation may prevent the user from removing plunger 440 from tubular container 430 after distal advancement of plunger 440 within tubular container 430.
[0849] Reference is now made to
[0850] Plunger 540 is shaped so as to define a first thread (configuration not shown) or one or more first thread segments 593 (as shown) that face radially inwardly and are configured to engage a corresponding second thread 595 that is defined by an external surface of tubular container 530 and faces radially outward. For some applications, plunger 540 comprises one or more thread supports 597, which extend proximally alongside at least a portion of plunger rod 582, separated from plunger rod 582 to provide a space for insertion of tubular container 530. The one or more thread supports 597 are shaped so as to define the first thread (configuration not shown) or the one or more first thread segments 593, respectively (as shown). Providing the threads may help the user apply sufficient and/or correct pressure to liquid specimen sample 22 for pushing liquid specimen sample 22 through a filter within tubular container 530.
[0851] Reference is now made to
[0852] Filters 660A, 660B, 660C, and 660D are shaped so as to define respective pluralities of slits 662A, 662B, 662C, and 662D therethrough. These slits may improve passage of liquid 1010 through the filter during bathing of the filter in collection vial 50 after the filter has been placed in collection vial 50, such as described hereinabove
[0853] Typically, when liquid specimen sample 22 is driven through the filters, liquid specimen sample 22 substantially does not pass through slits 662A, 662B, 662C, and 662D, but instead passes through pores of the filters, because the flat shape of the filters holds the edges of the slits together. This non-passage of liquid specimen sample 22 through slits in filters in a pattern similar to that of slits 662C was observed in experiments conducted by the inventors using gargled fluid as the liquid specimen sample.
[0854] For some applications, slits 662A, 662B, 662C, and 662D include respective radial-inward ends 664 and radially-outward ends 666, radially-inward ends 664 closer to a center 668 of the filters than are radially-outward ends 666. Optionally, radially-outward ends 666 are located on a perimeter 670 of the filters.
[0855] For some applications, the slits are curved, such as slits 662B and 662D. For some applications, the slits are straight, such as slits 662C. For some applications, the slits include segments angled with respect to one another, such as slits 662A.
[0856] For some applications, filters 660A, 660B, 660C, and 660D are shaped so as to define central regions 672 that are not shaped so as to define slits 662A, 662B, 662C, and 662D, respectively. Central regions 672 may have an area of at least 20 mm2, no more than 75 mm2, and/or between 20 and 75 mm2, and/or between 75% and 150% of an area of filter-support shaft-passage region 69 (e.g., filter-support opening 70).
[0857] Reference is now made to
[0860] For some applications, filtration assembly 24 comprises one or more release controls 700, which are configured to axially unlock filter support 62 and shaft 72 with respect to each other upon actuation of the one or more release controls 700 by the further second distal advancement of plunger head 42. For example, the one or more release controls 700 may comprise one or more pins 702, respectively, which extend proximally, and are actuated by being pushed distally.
[0861] For some applications, a locking assembly 710 is provided that comprises the one or more release controls 700 and one or more prongs 712 that engage shaft 72 (for example, respective indentations in shaft 72) when locking assembly 710 is in a locked state, such as shown in
[0862] Reference is now made to
[0863] Testing kit 1000 may be used, for example, for collecting liquid specimen sample 22 from the subject and sending at least a portion of the specimen sample to a remote laboratory in the liquid in collection vial 50, such as for performing Polymerase Chain Reaction (PCR) testing for particulate in liquid specimen sample 22.
[0864] The particulate may, for example, be a virus (e.g., an Influenza virus, or a coronavirus, such as SARS-CoV-2), a bacterium (e.g., Streptococcus bacteria, such as Streptococcus pyogenes (Strep A)), a microorganism, an antigen, a human cell, a cellular biomarker, a hormone, a chemical mediator from cells (e.g., a mediator of inflammation), a pollen, mucous, saliva, sputum, a respiratory particle, droplets derived from the upper and lower airways, a nucleic acid including DNA and RNA, and a chemical originating from external vapors. When the particulate is a microorganism, the microorganism may be either a pathogenic microorganism or a non-pathogenic microorganism or both, for example, viruses, bacteria, protozoa, and fungi. When the particulate is a human cell, the human cell may be an epithelial cell, for example, a columnar epithelial cell primarily derived from the nasal cavity and a squamous epithelial cell primarily derived from the oral cavity. The human cell may also be a cellular responder of the immune system, for example, neutrophils, eosinophils, lymphocytes, monocytes, macrophages, mast cells, and histocytes.
[0865] Optionally, a separate liquid container 1012 is provided that contains liquid 1010, such as shown. Alternatively, liquid 1010 is contained in collection vial cap 80 and released upon placement of cap 80 on collection vial 50 (configuration not shown).
[0866] Reference is now made to
[0867] Collection vial 1150 comprises an internal chamber 1151, which contains liquid 1010 and is configured to prevent spillage of liquid 1010 out of collection vial 1150 regardless of an orientation of collection vial 1150.
[0868] Typically, internal chamber 1151 contains a volume of liquid 1010 of at least 0.1 ml (e.g., at least 2 ml, such as 3 ml), no more than 5 ml, and/or between 0.1 ml (e.g., 2 ml) and 5 ml, such as 3 ml.
[0869] For some applications, sampling device 1120 further comprises a collection vial cap 1180, which is configured to seal vial opening 52, such as shown in the transition between
[0870] For example, collection vial cap 1180 may comprise a shaft 1153 that extends from an inner surface 1155 of collection vial cap 1180, and is configured to puncture internal chamber 1151 when collection vial cap 1180 is placed on vial opening 52. Shaft 1153 may or may not comprise a sharp tip 1157.
[0871] Reference is now made to
[0872] Reference is made to
[0873] For some applications, any of the collection vials described herein may comprise one or more small rigid spheres, contained within the vial. After liquid 1010 is placed or released within the collection vial and filter 60 is placed in the collection vial, such as described herein, the collection vial is agitated, such as shaken, which causes the spheres to break apart the filter, such as by macerating, crushing, shredding, or mashing the filter. This technique may be particularly useful when the filter comprises a fragile material, such as glass fibers. Optionally, the one or more spheres comprise a metal.
[0874] Reference is now made to
[0875] Reference is also made to
[0876] Reference is further made to
[0877] Sampling device 1320 typically comprises a filtration assembly 1324 and collection vial 50, which may have any of the properties described hereinabove. Filtration assembly 1324 comprises a tubular container 1330, a plunger 1340, and filter 60, which is disposed in tubular container 1330 and may have any of the properties described hereinabove with reference to
[0878] For some applications, filtration assembly 1324 comprises a plurality of filters (configuration not shown). Optionally, two or more of the plurality of filters touch one another, or are separated by one another by one or more thin spacers (e.g., having a thickness of at least 0.05 mm, no more than 1 mm, and/or between 0.05 and 1 mm. Alternatively or additionally, two or more of the plurality of filters are spaced apart from another, which case filtration assembly 1324 optionally comprises a corresponding number of filter supports.
[0879] Typically, tubular container 1330 has an internal volume of at least 0.5 ml (e.g., at least 1 ml, such as at least 5 ml), no more than 500 ml (e.g., no more than 70 ml), and/or between 0.5 ml (e.g., 1 ml or 5 ml) and 500 ml (e.g., 70 ml).
[0880] For some applications, tubular container 1330 does not comprise a Luer lock or any other type of needle-coupling mechanism.
[0881] Plunger 1340 comprises a plunger head 1342. Plunger 1340 is insertable into tubular container 1330 via proximal container opening 1332, such that a lateral surface 1346 of plunger head 1342 (labeled in
[0882] Collection vial 50 is disengageably coupled to filtration assembly 1324, such as to tubular container 1330 of filtration assembly 1324, or to a filter support 1362 of filtration assembly 1324, described hereinbelow. Once collection vial 50 has been decoupled from filtration assembly 1324, a diagnostic test may be performed for the presence of particulate trapped by filter 60, which is now in collection vial 50. For some applications, such as for transporting collection vial 50 to a remote diagnostic laboratory, sampling device 1320 further comprises collection vial cap 80, which is configured to seal vial opening 52, such as shown in
[0883] Filtration assembly 1324 is configured such that movement (typically distal advancement) of plunger head 1342 within tubular container 1330, when liquid specimen sample 22 is contained in tubular container 1330 and filter 60 is disposed in tubular container 1330, pushes at least a portion of liquid specimen sample 22 through filter 60. Filter 60 is configured to concentrate at least a portion of liquid specimen sample 22 onto filter 60, while allowing filtrate 61 to pass through filter 60. Typically, distal advancement of plunger 1340 within tubular container 1330 applies pressure to drive (e.g., push) at least a portion of liquid specimen sample 22 contained in tubular container 1330 through filter 60, such as shown in the transitions between
[0884] Sampling device 1320 is configured such that filter 60 is advanceable into (e.g., entirely into) collection vial 50 via vial opening 52 while collection vial 50 is disengageably coupled to filtration assembly 1324, such as shown in
[0885] For some applications, sampling device 1320 is configured such that filter 60 is advanceable into collection vial 50 via vial opening 52 while plunger head 1342 is within tubular container 1330, such as shown in
[0886] For some applications, filtration assembly 1324 is configured such that when plunger head 1342 is within tubular container 1330, fluid communication is blocked between (a) tubular container 1330 distal to plunger head 1342 and (b) proximal container opening 1332. For some of these applications, filter 60 is advanceable into collection vial 50 while plunger head 1342 is within tubular container 1330.
[0887] Typically, filtration assembly 1324 further comprises a waste liquid receptacle 1356 for receiving filtrate 61. For some applications, a distal portion of tubular container 1330 is shaped so as to define waste liquid receptacle 1356, such as shown in the drawings. For other applications, waste liquid receptacle 1356 is provided as a separate container coupled in fluid communication with tubular container 1330 downstream (distally) to filter 60.
[0888] Optionally, waste liquid receptacle 1356 is shaped so as to define an opening 1358 through an external wall of waste liquid receptacle 1356 to release displaced air. For example, opening 1358 may be located on a side portion of the external wall, typically above the highest level that filtrate 61 is expected to reach during ordinary use of the device. For some applications, waste liquid receptacle 1356 comprises an air filter (e.g., an N98 filter) that is disposed to filter air that passes out of waste liquid receptacle 1356 through opening 1358 (not shown). Alternatively or additionally, for some applications, waste liquid receptacle 1356 comprises a one-way pressure-sensitive valve disposed in opening 1358.
[0889] As mentioned above, collection vial 50 typically is not shaped so as to define any pressure-release openings and does not comprise any pressure-release valves.
[0890] For some applications, waste liquid receptacle 1356 contains a disinfectant or a liquid-absorbing material.
[0891] For some applications, sampling device 1320 further comprises a shaft 1372, and sampling device 1320 is configured such that that a distal portion 1377 of shaft 1372 is axially movable through vial opening 52 so as to advance filter 60 into collection vial 50 via vial opening 52, such as shown in
[0892] For some of these applications, shaft 1372 is coupled to plunger 1340. Typically, sampling device 1320 is configured such that shaft 1372 remains axially stationary with respect to plunger head 1342 during the movement of plunger head 1342 within tubular container 1330, such as shown in the transitions between
[0893] For some of these applications, plunger head 1342 is shaped so as to define a plunger-head opening 1344 through plunger head 1342, and shaft 1372 is slidable through plunger-head opening 1344, such as shown in the transitions between
[0894] For some applications, sampling device 1320 further comprises a fluid-tight frangible seal 1376. Collection vial 50 is positioned distal to filter 60 such that frangible seal 1376 removably blocks liquid flow into vial opening 52.
[0895] Frangible seal 1376 may be coupled to filter-support shaft-passage region 1369 (e.g., filter-support opening 1370), described hereinbelow (such as shown), vial opening 52 (configuration not shown), another element disposed between filter-support shaft-passage region 1369 (e.g., filter-support opening 1370) and vial opening 52 (configuration not shown), or a combination of these locations.
[0896] For example, frangible seal 1376 may comprise a pliable material (such as silicone) that is easily torn or a rigid material that is easily broken (e.g., shaped so as define slits to aid in breaking).
[0897] For some applications, filtration assembly 1324 further comprises a filter support 1362, which is disposed within tubular container 1330. Filter support 1362 is shaped so as to define: [0898] a proximal support surface 1364, which may be perpendicular to a central longitudinal axis of tubular container 1330 (as shown), or may be angled with respect to the central longitudinal axis (configuration not shown), and [0899] a plurality of filtrate-passage openings 1368 through filter support 1362. Filter 60 is disposed on proximal support surface 1364.
[0900] For some of these applications, filter support 1362 is shaped so as to further define a filter-support shaft-passage region 1369, which, for some applications, is shaped so as to define a filter-support opening 1370 through filter support 1362. For some of these applications, collection vial 50 is positioned distal to filter 60 such that frangible seal 1376 removably blocks liquid flow through filter-support shaft-passage region 1369 (e.g., filter-support opening 1370) into vial opening 52, such that upon breaching of frangible seal 1376 vial opening 52 is in fluid communication with filter-support shaft-passage region 1369 (e.g., filter-support opening 1370).
[0901] Filter-support shaft-passage region 1369 and filter-support opening 1370 may implement any of the features of filter-support shaft-passage region 69 and filter-support opening 70, respectively, as described hereinabove. In configurations in which frangible seal 1376 is provided, filter-support shaft-passage region 1369 is typically shaped so as to define filter-support opening 1370.
[0902] Typically, a cross-sectional area of filter-support shaft-passage region 1369 (e.g., filter-support opening 1370) is substantially larger than an average cross-sectional area of filtrate-passage openings 1368; for example, the cross-sectional area of filter-support shaft-passage region 1369 (e.g., filter-support opening 1370) may be at least 10 times, such as at least 25 times, the average cross-sectional area of filtrate-passage openings 1368.
[0903] For some applications: [0904] the cross-sectional area of filter-support shaft-passage region 1369 (e.g., filter-support opening 1370) is between 20 and 75 mm2, [0905] the average cross-sectional area of filtrate-passage openings 1368 is between 0.5 and 1.5 mm2, and/or [0906] For some applications, a cross-sectional area of filter-support shaft-passage region 1369 (e.g., filter-support opening 1370) is between 2.5% and 20% of a cross-sectional area of proximal support surface 1364 of filter support 1362.
[0907] For some applications in which filtration assembly 1324 comprises waste liquid receptacle 1356, waste liquid receptacle 1356 is disposed downstream of filter support 1362, and filter support 1362 is shaped so as to define filtrate-passage openings 1368 through filter support 1362 into waste liquid receptacle 1356. Typically filter support 1362 is not shaped so as to define filter-support shaft-passage region 1369 (e.g., filter-support opening 1370) through filter support 1362 into waste liquid receptacle 1356.
[0908] For some applications in which sampling device 1320 further comprises shaft 1372, filter support 1362 and shaft 1372 are configured such that that distal portion 1377 of shaft 1372 is axially movable through filter-support shaft-passage region 1369 (e.g., filter-support opening 1370) and vial opening 52 so as to breach of frangible seal 1376 and advance filter 60 into collection vial 50 via vial opening 52, such as shown in
[0909] For some of these applications, distal portion 1377 of shaft 1372, filter-support shaft-passage region 1369 (e.g., filter-support opening 1370), and vial opening 52 are coaxial. Alternatively or additionally, for some of these applications, distal portion 1377 of shaft 1372, filter-support shaft-passage region 1369 (e.g., filter-support opening 1370), and vial opening 52 are coaxial with or parallel to the central longitudinal axis of tubular container 1330.
[0910] For some applications, a cross-sectional area of distal portion 1377 of shaft 1372 is between 80% and 110% of a cross-sectional area of filter-support shaft-passage region 1369 (e.g., filter-support opening 1370).
[0911] For some applications, such as shown in
[0912] For some of these applications, plunger rod 1382 is shaped so as to define an internal plunger space 1386, and shaft 1372 is removably disposed at least partially within internal plunger space 1386. For some of these applications, a proximal end 1388 of plunger rod 1382 is shaped so as to define a plunger-space proximal opening 1390 of internal plunger space 1386, and shaft 1372 is slidably disposed at least partially within internal plunger space 1386. Typically, a proximal portion 1374 of shaft 1372 is accessible via plunger-space proximal opening 1390 of internal plunger space 1386.
[0913] For some applications, sampling device 1320 is configured such that collection vial 50 is decouplable from filtration assembly 1324 while plunger head 1342 is within tubular container 1330, such as shown in
[0914] For some applications, sampling device 1320 is configured such that collection vial 50 is decouplable from filtration assembly 1324 by distal movement of collection vial 50 with respect to tubular container 1330, such as shown in
[0915] For some applications in which filtration assembly 1324 further comprises waste liquid receptacle 1356, collection vial 50 is disposed at least partially alongside waste liquid receptacle 1356, such as shown in
[0916] For some applications, waste liquid receptacle 1356 surrounds collection vial 50, such as shown in
[0917] For some applications, sterile packaging is provided, in which at least sampling device 1320 is removably disposed.
[0918] Reference is made to
[0919] Reference is again made to
[0925] For some applications, liquid specimen sample 22 is received from a subject's mouth. For some applications, liquid specimen sample 22 comprises gargled fluid, such as described hereinabove with reference to
[0926] For some applications in which the method does not comprise swabbing the throat of the subject, liquid specimen sample 22 is collected by drawing liquid specimen sample 22 out of an oral cavity of the subject via an anterior opening of the oral cavity, such as described hereinabove with reference to
[0927] For some applications, filter 60 is advanced into collection vial 50 via vial opening 52 while plunger head 1342 is within tubular container 1330, such as shown in
[0928] For some applications in which filtration assembly 1324 is configured such that when plunger head 1342 is within tubular container 1330, fluid communication is blocked between (a) tubular container 1330 distal to plunger head 1342 and (b) proximal container opening 1332, filter 60 is advanced into collection vial 50 via vial opening 52 while plunger head 1342 is within tubular container 1330, such as shown in
[0929] For some applications in which sampling device 1320 further includes shaft 1372, filter 60 is advanced into collection vial 50 by axially moving distal portion 1377 of shaft 1372 through vial opening 52, such as shown in
[0930] For some applications in which shaft 1372 is coupled to plunger 1340, plunger head 1342 is distally advanced within tubular container 1330 while shaft 1372 remains axially stationary with respect to plunger head 1342, such as shown in
[0931] For some applications, filter 60 is advanced into collection vial 50 by axially moving distal portion 1377 of shaft 1372 through filter-support shaft-passage region 1369 (e.g., filter-support opening 1370) and vial opening 52 so as to breach of frangible seal 1376 and advance filter 60 into collection vial 50 via vial opening 52.
[0932] Such as described above, for some applications, plunger 1340 comprises plunger rod 1382, which is shaped so as to define internal plunger space 1386, shaft 1372 is slidably disposed at least partially within internal plunger space 1386, and proximal end 1388 of plunger rod 1382 is shaped so as to define plunger-space proximal opening 1390 of internal plunger space 1386. For some applications, the method further comprises accessing proximal portion 1374 of shaft 1372 via plunger-space proximal opening 1390 of internal plunger space 1386, such as in order to axially advance shaft 1372.
[0933] For some applications, decoupling collection vial 50 is decoupled from filtration assembly 1324 while plunger head 1342 is within tubular container 1330, such as shown in
[0934] For some applications, collection vial 50 is decoupled from filtration assembly 1324 by distally moving collection vial 50 with respect to tubular container 1330, such as shown in
[0935] For some applications, the method further comprises sealing vial opening 52 with a collection vial cap after filter 60 has been advanced into collection vial 50, such as shown in
[0936] For some applications, the method further comprises bathing filter 60 with liquid 1010 within collection vial 50 after filter 60 has been advanced into collection vial 50, such as shown in
[0937] For some applications, the method further comprises, after filter 60 has been advanced into collection vial 50, detecting the presence of a biological particulate trapped by filter 60, such as described hereinabove with reference to
[0938] In some applications of the present invention (configuration not shown), a sampling device is provided that is similar in some respects to sampling device 1320, and may implement any of the features thereof, mutatis mutandis. This sampling device, unlike sampling device 1320, does not comprise plunger 1340. This sampling device instead comprises a different liquid-pressure source. For example, the liquid-pressure source may comprise a positive-pressure pump (e.g., a hydraulic pump, a syringe, or a motorized and/or electrical pump) disposed upstream of filter 60; optionally, for some applications, the positive-pressure pump comprises a chamber with one or more flexible walls, the squeezing of which pumps liquid specimen sample 22 and/or air.
[0939] In an application of the present invention (not shown), the proximal portion of the shaft is axially movable with respect to the proximal container opening.
[0940] For some applications, the sampling device is configured to automatically axially move the shaft through the filter-support shaft-passage region, the plunger-head opening, and the vial opening.
[0941] For some applications, the sampling device further comprises a spring, which is configured to axially move the proximal portion of the shaft with respect to the proximal container opening.
[0942] For some applications, the tubular container includes a distal tubular portion that is distal to the filter support and is configured to have an adjustable length. The sampling device is configured such that shortening of the adjustable length axially moves the shaft through the filter-support shaft-passage region, the plunger-head opening, and the vial opening. For example, the distal tubular portion may be axially collapsible to provide the shortening of the length of the distal tubular portion.
[0943] Reference is now made to
[0944] Reference is also made to
[0945] Reference is also made to
[0946] Reference is further made to
[0947] Sampling device 1420 typically comprises a filtration assembly 1424 and a collection vial 1450, which may have any of the properties described hereinabove. Filtration assembly 1424 comprises a tubular container 1430, a plunger 1440, and filter 60, which may have any of the properties described hereinabove with reference to
[0948] Collection vial 1450 typically is not shaped so as to define any pressure-release openings and does not comprise any pressure-release valves.
[0949] For some applications, filtration assembly 1424 comprises a plurality of filters (configuration not shown), optionally having any of the multi-filter configurations described hereinabove. Typically, tubular container 1430 may optionally have any of the characteristics, including, but not limited to, volume) of the tubular containers described hereinabove. For some applications, tubular container 1430 does not comprise a Luer lock or any other type of needle-coupling mechanism.
[0950] As labeled in
[0951] Collection vial 1450 is disengageably coupled to filtration assembly 1424, such as described hereinbelow. Once collection vial 1450 has been decoupled from filtration assembly 1424, a diagnostic test may be performed for the presence of particulate trapped by filter 60, which is now in collection vial 1450. For some applications, such as for transporting collection vial 1450 to a remote diagnostic laboratory, sampling device 1420 further comprises collection vial cap 80, which is configured to seal vial opening 1452, such as shown for collection vial 50 in
[0952] Filtration assembly 1424 is configured such that movement (typically distal advancement) of plunger head 1442 within tubular container 1430, when liquid specimen sample 22 is contained in tubular container 1430 and filter 60 is disposed in tubular container 1430, pushes at least a portion of liquid specimen sample 22 through filter 60. Filter 60 is configured to concentrate at least a portion of liquid specimen sample 22 onto filter 60, while allowing filtrate 61 to pass through filter 60. Typically, distal advancement of plunger 1440 within tubular container 1430 applies pressure to drive (e.g., push) at least a portion of liquid specimen sample 22 contained in tubular container 1430 through filter 60, such as shown in the transitions between
[0953] Sampling device 1420 is configured such that filter 60 is advanceable into (e.g., entirely into) collection vial 1450 via vial opening 1452 while collection vial 1450 is disengageably coupled to filtration assembly 1424, such as shown in
[0954] For some applications, such as shown in
[0955] For some of these applications, plunger rod 1482 is shaped so as to define an internal plunger space 1486. For some of these applications, a proximal end 1488 of plunger rod 1482 is shaped so as to define a plunger-space proximal opening 1490 of internal plunger space 1486. Plunger head 1442 is shaped so as to define a plunger-head opening 1444 through plunger head 1442 and into internal plunger space 1486.
[0956] Typically, collection vial 1450 is removably disposed at least partially within internal plunger space 1486.
[0957] Typically, collection vial 1450 is positioned proximal to plunger head 1442.
[0958] For some of these applications, collection vial 1450 is removably disposed at least partially within internal plunger space 1486 while collection vial 1450 is an axially-compressed configuration, such as shown in
[0959] Sampling device 1420 is typically configured such that filter 60 is removable from tubular container 1430 via plunger-space proximal opening 1490 while plunger head 1442 is within tubular container 1430 (filter 60 is also removable from tubular container 1430 via plunger-space proximal opening 1490 if plunger head 1442 has been removed from tubular container 1430).
[0960] Typically, filtration assembly 1424 further comprises a waste liquid receptacle 1456 for receiving filtrate 61. For some of these applications, plunger rod 1482 is shaped so as to define therewithin waste liquid receptacle 1456. Typically, waste liquid receptacle 1456 partially or entirely surrounds internal plunger space 1486, such as shown.
[0961] Filtration assembly 1424 is configured such that movement of plunger head 1442 within tubular container 1430, when liquid specimen sample 22 is contained in tubular container 1430 and filter 60 is disposed in tubular container 1430, pushes at least a portion of liquid specimen sample 22 through filter 60 and filtrate-passage openings 1468 (described hereinbelow) and into waste liquid receptacle 1456.
[0962] For some applications, waste liquid receptacle 1456 contains a disinfectant or a liquid-absorbing material.
[0963] Optionally, waste liquid receptacle 1456 is shaped so as to define an opening through an external wall of waste liquid receptacle 1456 to release displaced air, similar to opening 58 of waste liquid receptacle 56, described hereinabove with reference to
[0964] For some applications, plunger head 1442 is shaped so as to define a filter support 1462, which is shaped so as to define: [0965] a distal support surface 1459, which may be perpendicular to a central longitudinal axis of plunger head 1442 (as shown), or may be angled with respect to the central longitudinal axis (configuration not shown), [0966] a plurality of filtrate-passage openings 1468 through filter support 1462 into waste liquid receptacle 1456, and [0967] plunger-head opening 1444 (labeled in
[0968] Filter 60 is (removably) disposed on distal support surface 1459.
[0969] For some applications, sampling device 1420 comprises a filter-withdrawal shaft 1472, which includes a distal portion 1408 (labeled in
[0971] For some applications, sampling device 1420 comprises a distal plate 1471 (labeled in
[0972] For some applications, plunger-space proximal opening 1490 and a longitudinal portion of filter-withdrawal shaft 1472 are shaped so as to define corresponding female and male screw threads 1423A and 1423B (labeled in
[0973] Optionally, in configurations in which plunger 1440 and tubular container 430 are threadingly coupled to each other, such as described hereinabove with reference to
[0974] For other applications, plunger-space proximal opening 1490 and filter-withdrawal shaft 1472 are not threadingly coupled together.
[0975] As mentioned above, for some applications, collection vial 1450 is removably disposed at least partially within internal plunger space 1486 while collection vial 1450 is the axially-compressed configuration, such as shown in
[0976] For some applications, sampling device 1420 further comprises a shaft handle 1405, which is coupled to a proximal portion of filter-withdrawal shaft 1472.
[0977] For some applications, sampling device 1420 is configured such that collection vial 1450 is decouplable from filtration assembly 1424 while plunger head 1442 is within tubular container 1430, such as shown in
[0978] For some applications, sterile packaging is provided, in which at least sampling device 1420 is removably disposed.
[0979] Reference is still made to
[0980] The method comprises: [0981] placing liquid specimen sample 22 in tubular container 1430 of filtration assembly 1424, such as shown in
[0985] For some applications, liquid specimen sample 22 may be acquired and/or may have any of the characteristics described hereinabove.
[0986] For some applications, the method further comprises, after filter 60 has been removed from tubular container 1430, detecting the presence of a biological particulate trapped by filter 60, such as described hereinabove with reference to
[0987] For some applications in which sampling device 1420 comprises a filter-withdrawal shaft, the filter-withdrawal shaft is not pre-coupled to filter 60 (configuration not shown). Instead, the filter-withdrawal shaft is advanced within internal plunger space 1486 (and optionally inserted into plunger space 1486) and coupled to filter 60 after plunger 1440 has been inserted into tubular container 1430 (and optionally been moved within tubular container 1430 to push the at least a portion of liquid specimen 22 through filter 60).
[0988] Reference is now made to
[0989] Reference is also made to
[0990] Reference is also made to
[0991] Reference is further made to
[0992] Reference is also made to
[0993] Reference is also made to
[0994] Reference is also made to
[0995] Reference is further made to
[0996] Sampling device 1520A and sampling device 1520B are two configurations of sampling device 1520, and are identical other than as described hereinbelow.
[0997] Other than as described hereinbelow, sampling device 1520 is generally similar to sampling device 1420 described hereinabove with reference to
[0998] Sampling device 1520A comprises a collection vial 1550, 1550A and sampling device 1520B comprises a collection vial 1550, 1550B. Sampling device 1520A comprises a filtration assembly 1524, 1524A and sampling device 1520B comprises a filtration assembly 1524, 1524B.
[0999] Unlike in sampling device 1420, in sampling device 1520, when collection vial 1550 is initially disengageably coupled to filtration assembly 1524, such as shown in
[1000] Collection vial 1550 comprises a flexible material and is removably disposed at least partially within an internal plunger space 1586 of a plunger 1540 while collection vial 1550 is an inverted configuration, in which the inverted collection vial 1550 defines a proximal vial opening 1507, such as shown in
[1001] As labeled in
[1002] For some applications, sampling device 1520 comprises a filter-withdrawal shaft 1572, which is disposed partially within the inverted collection vial 1550 within internal plunger space 1586. Filter-withdrawal shaft 1572 includes a distal portion 1508 that is directly or indirectly coupled to filter 60, typically via an end 1504 of collection vial 1450 opposite a vial opening 1502. Sampling device 1520 is configured such that proximal withdrawal of filter-withdrawal shaft 1572 out of internal plunger space 1586, while plunger head 1542 is within tubular container 1430: [1003] inverts the inverted collection vial 1550 to an uninverted configuration, as shown in the transitions between
[1007] In the uninverted configuration, collection vial 1550 is shaped so as to define a vial opening 1502.
[1008] Optionally, a longitudinal portion of filter-withdrawal shaft 1572 that passes through plunger-head opening 1544 is narrower than a more proximal portion of filter-withdrawal shaft 1572.
[1009] Optionally, a portion 1515 of filter-withdrawal shaft 1572 is cylindrical (e.g., tubular) and has an outer diameter that is approximately equal to an inner diameter of the inverted collection vial 1550, in order to help maintain the inverted collection vial 1550 in the inverted configuration, such as shown in
[1010] It is noted that filter-withdrawal shaft 1572 of sampling device 1520 is not an element of filtration assembly 1524, but instead is removable therefrom, as shown in
[1011] Reference is now made to
[1012] Reference is now made to
[1013] Reference is again made to
[1014] The method comprises: [1015] placing liquid specimen sample 22 in tubular container 1430 of filtration assembly 1524, such as shown in
[1019] For some applications, filter 60 is removed from tubular container 1430 by proximally withdrawing filter-withdrawal shaft 1572 out of internal plunger space 1586, while plunger head 1542 is within tubular container 1430, so as to invert the inverted collection vial 1550 to an uninverted configuration (as shown in the transition between
[1020] For some applications, liquid specimen sample 22 may be acquired and/or may have any of the characteristics described hereinabove.
[1021] For some applications, the method further comprises, after filter 60 has been removed from tubular container 1430, detecting the presence of a biological particulate trapped by filter 60, such as described hereinabove with reference to
[1022] Reference is now made to
[1023] In this configuration, when collection vial 1550 is in the uninverted configuration, such as shown in
[1024] For some applications, vial threaded interface 1506A and shaft threaded interface 1506B are threaded, such as shown in
[1025] Typically, after collection vial 1550 has been removed internal plunger space 1586 and has assumed the uninverted configuration shown in
[1026] Reference is now made to
[1027] Reference is also made to
[1028] Reference is also made to
[1029] Reference is further made to
[1030] Other than as described hereinbelow, sampling device 1620 is generally similar to sampling device 1420 described hereinabove with reference to
[1031] Sampling device 1620 comprises a filtration assembly 1624 and a collection vial 1650, which may have any of the properties described hereinabove. However, unlike collection vial 1450, described hereinabove with reference to
[1032] Filtration assembly 1624 comprises tubular container 1430, a plunger 1640 (labeled in
[1033] Sampling device 1620 is typically configured such that filter 60 is removable from tubular container 1430 via a plunger-space proximal opening 1690 while a plunger head 1642 of plunger 1640 is within tubular container 1430 (filter 60 is also removable from tubular container 1430 via plunger-space proximal opening 1690 if plunger head 1642 has been removed from tubular container 1430). Plunger head 1642 is shaped so as to define a plunger-head opening 1644 through plunger head 1642 and into an internal plunger space 1686 of plunger 1640.
[1034] Sampling device 1620 is configured such that filter 60 is advanceable into (e.g., entirely into) collection vial 1650 via a vial opening 1652 while collection vial 1650 is disengageably coupled to filtration assembly 1624, such as shown in
[1035] For some applications, sampling device 1620 is configured such that filter 60 is advanceable into collection vial 1650 via vial opening 1652 while plunger head 1642 is within tubular container 1430, such as shown in
[1036] For some applications, sampling device 1620 comprises a filter-withdrawal shaft 1672, which: [1037] is disposed partially within collection vial 1650 within an internal plunger space 1686, [1038] includes a proximal portion 1687 that is slidably disposed passing through a shaft-passage hole 1605 through an end 1604 of collection vial 1650 opposite vial opening 1652 (labeled in
[1040] Sampling device 1620 is configured such that proximal withdrawal of filter-withdrawal shaft 1672, while plunger head 1642 is within tubular container 1430, pulls filter 60 into collection vial 1650 via plunger-head opening 1644 via vial opening 1652 (as shown in the transitions between
[1041] Typically, sampling device 1620 is configured such that further proximal withdrawal of filter-withdrawal shaft 1672 out of internal plunger space 1686, while plunger head 1642 is within tubular container 1430, pulls collection vial 1650 out of internal plunger space 1686 via plunger-space proximal opening 1690 (as shown in the transitions between
[1042] For some applications, sampling device 1620 further comprises a seal 1614 that inhibits fluid leakage between proximal portion 1687 of filter-withdrawal shaft 1672 and shaft-passage hole 1605.
[1043] Optionally, an inner portion of seal 1614 may snap into an external circumferential groove of proximal portion 1687 of filter-withdrawal shaft 1672 upon the proximal withdrawal of most or all of filter-withdrawal shaft 1672 from collection vial 1650, such as shown in
[1044] Reference is now made to
[1047] It will be appreciated by persons skilled in the art who have read the present application that the distal portions of the filter-withdrawal shafts may be directly or indirectly coupled to the filter in additional ways, all of which are within the scope of the present invention.
[1048] Reference is now made to
[1049] Reference is also made to
[1050] Reference is also made to
[1051] Other than as described hereinbelow, sampling device 1720 is generally similar to sampling device 1420 described hereinabove with reference to
[1052] Similar to sampling device 1420, sampling device 1720 typically comprises a filtration assembly 1724, which may have any of the properties described hereinabove. Filtration assembly 1724 comprises tubular container 1430, a plunger 1740, and filter 60, which may have any of the properties described hereinabove with reference to
[1053] Plunger head 1742 is shaped so as to define a plunger-head opening 1744 through plunger head 1742 and into an internal plunger space 1786 of a plunger rod 1782. A proximal end of plunger rod 1782 is shaped so as to define a plunger-space proximal opening 1790 of internal plunger space 1786.
[1054] Sampling device 1720 comprises a filter-withdrawal shaft 1772, which includes a distal portion 1708 (labeled in
[1057] It will be appreciated by persons skilled in the art who have read the present application that the distal portion of the filter-withdrawal shaft may be directly or indirectly coupled to the filter in additional ways, all of which are within the scope of the present invention.
[1058] Sampling device 1720 is configured such that proximal withdrawal of filter-withdrawal shaft 1772 out of internal plunger space 1786, while plunger head 1742 is within tubular container 1430, pulls filter 60 into internal plunger space 1786 via plunger-head opening 1744 and out of internal plunger space 1786 via plunger-space proximal opening 1790, and removes filter-withdrawal shaft 1772 and filter 60 from filtration assembly 1724. At least a portion of filter 60 is typically bunched up, such as into a flower-like arrangement, from the filter's initial flat shape while disposed on the filter support.
[1059] It is noted that filter-withdrawal shaft 1772 of sampling device 1720 is not an element of filtration assembly 1724, but instead is removable therefrom, as shown in
[1060] Typically, but not necessarily, after filter-withdrawal shaft 1772 and filter 60 have been removed from filtration assembly 1724, filter 60 and at a portion of filter-withdrawal shaft 1772 are inserted into extraction tube 1718, such as shown in
[1061] For some applications, sampling device 1720 comprises a filter receptacle 1714 that is slidably coupled to a distal end portion of filter-withdrawal shaft 1772 and shaped so as to define a distal receptacle opening 1716. Sampling device 1720 is configured such that the proximal withdrawal of filter-withdrawal shaft 1772 out of internal plunger space 1786, while plunger head 1742 is within tubular container 1430, pulls a portion of filter 60 into filter receptacle 1714 via distal receptacle opening 1716. For example, the portion of filter 60 may include a central portion (as viewed when filter 60 is flat). This pulling of the portion of filter 60 into filter receptacle 1714 typically causes the remainder of filter 60 to become bunched up, such as into a flower-like arrangement, and be disposed at least partially outside filter receptacle 1714, from the filter's initial flat shape while disposed on the filter support. The bunched-up filter may function somewhat analogously to a conventional swab, and, because of the reduced diameter because of the bunching up, may be readily inserted into extraction tube 1718, such as described above and shown in
[1062] Reference is still made to
[1063] Reference is additionally made to
[1064] Sampling device 1720, 1720A, 1720B further comprises an extraction-tube cap 1719, which is disposed radially surrounding filter-withdrawal shaft 1772 along a first longitudinal portion 1773A of filter-withdrawal shaft 1772, such that a distal second longitudinal portion 1773B of filter-withdrawal shaft 1772 is distal to extraction-tube cap 1719 (labeled in
[1065] Reference is still made to
[1066] For some applications, such as shown, proximal third longitudinal portion 1773C is longitudinally connected to first longitudinal portion 1773A of filter-withdrawal shaft 1772 by a fourth longitudinal portion 1773D of filter-withdrawal shaft 1772 longitudinally between predetermined separation border 1775 and extraction-tube cap 1719. For other applications, proximal third longitudinal portion 1773C is directly longitudinally adjacent extraction-tube cap 1719 (configuration not shown).
[1067] For some applications, predetermined separation border 1775 is defined by one or more of the following features: [1068] a lesser cross-sectional area of filter-withdrawal shaft 1772 at predetermined separation border 1775 than longitudinally adjacent to predetermined separation border 1775, such as shown in the figures, [1069] scoring, such as shown in the figures, [1070] perforation (configuration not shown), [1071] corresponding male and female screw threads (configuration not shown), and/or [1072] corresponding male and female tapered friction-fitting surfaces (configuration not shown).
[1073] For some applications, a method of using sampling device 1720 comprises separating, at predetermined separation border 1775, proximal third longitudinal portion 1773C from filter-withdrawal shaft 1772 distal to predetermined separation border 1775. For applications in which predetermined separation border 1775 is defined by the lesser cross-sectional area of filter-withdrawal shaft 1772 at predetermined separation border 1775 than longitudinally adjacent to predetermined separation border 1775, separating comprises breaking filter-withdrawal shaft 1772 at predetermined separation border 1775. For applications in which predetermined separation border 1775 is defined by scoring or perforation, separating comprises breaking filter-withdrawal shaft 1772 at predetermined separation border 1775. For applications in which predetermined separation border 1775 is defined by corresponding male and female screw threads, separating comprises unscrewing the male and the female screw threads from each other. For applications in which predetermined separation border 1775 is defined by corresponding male and female tapered friction-fitting surfaces, separating comprises separating the male and the female tapered friction-fitting surfaces from each other.
[1074] Reference is again made to
[1077] Reference is still made to
[1078] For some applications (configuration not shown), filter-withdrawal shaft 1772, 1772A is not shaped so as to define predetermined separation border 1775. For some of these applications (configuration not shown), filter-withdrawal shaft 1772, 1772A is shaped so as to define an internal channel that passes longitudinally through filter-withdrawal shaft 1772, 1772A and is open at a proximal end of the filter-withdrawal shaft. Typically, the proximal opening of the internal channel is sealed by a removable plug.
[1079] Reference is made to
[1080] Reference is now made to
[1081] In an embodiment, the techniques and apparatus described herein are combined with techniques and apparatus described in one or more of the following patent applications, which are assigned to the assignee of the present application and are incorporated herein by reference: [1082] PCT Publication WO 2018/158768 to Fruchter et al., and US Patent Application Publication 2019/0381498 in the national stage thereof; [1083] U.S. Provisional Application 62/727,208, filed Sep. 5, 2018; [1084] U.S. Provisional Application 62/727,268, filed Sep. 5, 2018; [1085] PCT Publication WO 2020/049566 to Fruchter et al.; [1086] PCT Publication WO 2020/049569 to Fruchter et al., and US Patent Application Publication 2021/0215585 in the national stage thereof; [1087] U.S. Provisional Application 62/896,295, filed Sep. 5, 2019; [1088] U.S. Provisional Application 62/988,145, filed Mar. 11, 2020; [1089] U.S. Provisional Application 62/988,259, filed Mar. 11, 2020; [1090] U.S. Provisional Applications 63/020,723, filed May 6, 2020; 63/037,707, filed Jun. 11, 2020; 63/067,535, filed Aug. 19, 2020; 63/117,294, filed Nov. 23, 2020; 63/156,843, filed Mar. 4, 2021; 63/158,005, filed Mar. 8, 2021; 63/166,378, filed Mar. 26, 2021; and 63/176,565, filed Apr. 19, 2021; [1091] U.S. Provisional Application 63/071,529, filed Aug. 28, 2020; [1092] International Application PCT/IL2020/050957, filed Sep. 3, 2020, which published as PCT Publication WO 2021/044417 to Holtz et al.; [1093] US Patent Application Publication 2021/0102876 to Fruchter et al.; [1094] PCT Publication WO 2021/181339 to Feldman et al.; [1095] PCT Publication WO 2021/181338 to Fruchter et al.; [1096] PCT Publication WO 2021/224925 to Levitz et al.; [1097] International Application PCT/IL2021/051035, filed Aug. 24, 2021, which published as WO 2022/044002 to Levitz et al.; and/or [1098] U.S. Provisional Application 63/134,282, filed Jan. 6, 2021.
[1099] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.