US-20260126357-A1 - FILTRATION SAMPLING DEVICES

US20260126357A1US 20260126357 A1US20260126357 A1US 20260126357A1US-20260126357-A1

Abstract

A sampling device ( 2220 F, 2620 , 2720 ) is provided for concentrating a liquid specimen sample ( 22 ), including a filtration assembly ( 2224 F, 2624 , 2724 ) which includes a tubular container ( 1630 , 2030 ), a filter ( 60 ), a filter support ( 1662 , 2362 ), and an inflatable chamber ( 2700 ). The filter support ( 1662 , 2362 ) defines a support surface on which the filter ( 60 ) is removably disposed. The inflatable chamber ( 2700 ) includes a flexible wall ( 2702 ). An interior of the inflatable chamber ( 2700 ) is shaped so as to define a space ( 2733 ) having an initial volume. A source of gas ( 2204 ) is configured to provide gas ( 2208 ) into the space ( 2733 ). The filtration assembly ( 2224 F, 2624 , 2724 ) is configured such that providing of the gas ( 2208 ) into the space ( 2733 ), when the liquid specimen sample ( 22 ) is contained in the tubular container ( 1630 , 2030 ) and the filter ( 60 ) is disposed on the support surface, increases the initial volume to an inflated volume, so as to push at least a portion of the liquid specimen sample ( 22 ) through the filter ( 60 ). Other embodiments are also described.

Inventors

Robert Eric LEVITZ
Zvi Feldman

Assignees

HERO SCIENTIFIC LTD.

Dates

Publication Date: 20260507
Application Date: 20260105

Claims (20)

1 . A sampling device for concentrating a liquid specimen sample, the sampling device comprising a filtration assembly, which comprises: a tubular container, which is shaped so as to define an inner wall and a proximal container opening for receiving the liquid specimen sample; a waste liquid receptacle; a filter; a filter support, which is shaped so as to define (a) a support surface on which the filter is removably disposed, and (b) a plurality of filtrate-passage openings through the filter support into the waste liquid receptacle; an inflatable chamber, which comprises a flexible wall, wherein an interior of the inflatable chamber is shaped so as to define a space having an initial volume; and a source of gas, configured to provide gas into the space defined by the interior of the inflatable chamber, wherein the filtration assembly is configured such that providing of the gas into the space, when the liquid specimen sample is contained in the tubular container and the filter is disposed on the support surface, increases the initial volume to an inflated volume, so as to push at least a portion of the liquid specimen sample through the filter and the filtrate-passage openings and into the waste liquid receptacle.
2 . The sampling device according to claim 1 , wherein the source of gas comprises one or more substances that generate the gas.
3 . The sampling device according to claim 1 , wherein the source of gas comprises a compressed gas container containing the gas.
4 . The sampling device according to claim 1 , wherein the source of gas is configured to provide the gas upon manual activation of the source of gas.
5 . The sampling device according to claim 4 , wherein the filtration assembly comprises a user control, which is configured, upon actuation thereof, to manually activate the source of gas to provide the gas.
6 . The sampling device according to claim 1 , wherein the providing of the gas into the space expands the inflatable chamber toward the filter.
7 . The sampling device according to claim 6 , wherein the providing of the gas into the space expands the inflatable chamber into contact with the filter.
8 . The sampling device according to claim 6 , wherein the inflatable chamber, when the space has the initial volume, is disposed away from the filter.
9 . The sampling device according to claim 1 , wherein the providing of the gas into the space increases an area of contact between the inflatable chamber and the filter.
10 . The sampling device according to any one of claims 1-9 , wherein an internal distal bottom surface of the tubular container comprises the filter support, and wherein the providing of the gas into the space expands the inflatable chamber when the inflatable chamber is disposed at least partially in the tubular container.
11 . The sampling device according to claim 10 , wherein the filtration assembly further comprises a proximal cap, which is configured to sealably close the proximal container opening, and wherein the inflatable chamber is coupled to the proximal cap, such that the inflatable chamber is disposed at least partially in the tubular container when the proximal cap sealably closes the proximal container opening.
12 . The sampling device according to any one of claims 1-9 , wherein the filtration assembly further comprises a proximal cap, which is configured to sealably close the proximal container opening, wherein the proximal cap is shaped so as to define the waste liquid receptacle within the proximal cap, wherein the proximal cap comprises the filter support, and wherein the inflatable chamber is disposed at least partially in the tubular container.
13 . The sampling device according to any one of claims 1-9 , wherein the filtration assembly further comprises a plunger, which (i) comprises a plunger head and a plunger rod, which has a distal end portion to which the plunger head is coupled, and (ii) 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 of the tubular container, wherein the plunger rod is shaped so as to define the waste liquid receptacle within the plunger rod, wherein the plunger head comprises the filter support, wherein the sampling device further comprises a container housing, wherein the tubular container is disposed at least partially within the container housing, such that the tubular container is moveable with respect to the container housing, wherein the inflatable chamber is disposed between (a) a proximally-facing internal surface of the container housing and (b) an external surface of the tubular container that is defined by a distal end of the tubular container, and wherein the filtration assembly is configured such that the providing of the gas into the space increases the initial volume to the inflated volume, thereby proximally moving the tubular container with respect to the plunger head, thereby pushing the at least a portion of the liquid specimen sample through the filter and the filtrate-passage openings and into the waste liquid receptacle.
14 . The sampling device according to any one of claims 1-9 , wherein the filtration assembly comprises one or more sharp surfaces, which are positioned to puncture the inflatable chamber upon the space increasing to the inflated volume.
15 . The sampling device according to any one of claims 1-9 , wherein the filtration assembly further comprises a pressure-responsive valve that is configured to limit a pressure within the space.
16 . The sampling device according to claim 15 , wherein the pressure-responsive valve is configured to limit the pressure in the space by blocking flow of the gas into the space responsively to the pressure in the space.
17 . The sampling device according to claim 16 , wherein the filtration assembly is shaped so as to define a gas-release regulation chamber, which is in fluid communication with the space only by one or more openings, wherein the source of gas is disposed in fluid communication with the gas-release regulation chamber, and wherein the pressure-responsive valve is configured to block the flow of the gas into the space by blocking the one or more openings.
18 . The sampling device according to claim 16 , wherein the source of gas comprises a compressed gas container containing the gas and defining an opening in fluid communication with the space, and wherein the pressure-responsive valve is configured to block the flow of the gas into the space by blocking the opening.
19 . The sampling device according to claim 15 , wherein the pressure-responsive valve comprises a pressure relief valve, which is configured to release a portion of the gas from the space when the pressure within the space exceeds a threshold pressure.
20 . The sampling device according to claim 19 , wherein the pressure relief valve is located so as to release the portion of the gas from the space to the atmosphere outside the filtration assembly when the pressure within the space exceeds the threshold pressure.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application: (i) is a continuation of International Application PCT/IL2024/050679, filed Jul. 11, 2024, which published as PCT Publication WO 2025/012908 to Feldman et al., which (a) claims the benefit of U.S. Provisional Application 63/621,875, filed Jan. 17, 2024, and (b) claims priority from and is a continuation-in-part of International Application PCT/IL2023/050728, filed Jul. 12, 2023, which published as PCT Publication WO 2024/013747 to Feldman et al., and(ii) is a continuation-in-part (CIP) of U.S. application Ser. No. 19/012,335, filed Jan. 7, 2025, which published as US Patent Application Publication 2025/0144616 to Feldman et al., which is a continuation of International Application PCT/IL2023/050728, filed Jul. 12, 2023, which published as PCT Publication WO 2024/013747 to Feldman et al.; International Application PCT/IL2023/050728, filed Jul. 12, 2023, claims the benefit of US Provisional Application 63/388,851, filed Jul. 13, 2022, and U.S. Provisional Application 63/432,231, filed Dec. 13, 2022. All of the above-mentioned applications are assigned to the assignee of the present application and incorporated herein by reference. FIELD OF THE APPLICATION Applications of the present invention relate to sampling biological liquids. BACKGROUND OF THE APPLICATION Many techniques exist for testing for the presence of bacteria and viruses for aiding in disease diagnosis. For example, testing for the influenza virus includes molecular-based detection methods, viral culture methods, and immunoassay methods. Influenza virus testing includes the testing of nasal swabs, nasopharyngeal swabs, nasal aspirates, nasopharyngeal aspirates, nasal washes, nasopharyngeal washes, throat swabs, and a combination of samples. PCT Publication WO 2018/158768 to Fruchter et al. describes inter alia a method for testing for presence of a particulate selected from the group consisting of: a microorganism, a fungus, a bacteria, a spore, a virus, a mite, a biological cell, a biological antigen, a protein, a protein antigen, and a carbohydrate antigen. The method includes (a) collecting, in a tube, fluid that potentially contains the particulate, (b) using a plunger to push the fluid through a filter removably disposed at a distal portion of the tube or at a distal end of the plunger, and subsequently, (c) while the filter is inside the tube, ascertaining if any of the particulate was trapped by the filter by applying a particulate-presence-testing-facilitation solution to the filter. PCT Publication WO 2022/149135 to Feldman et al. describes inter alia a sampling device 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. PCT Publication WO 2023/131948 to Levitz et al., which is incorporated herein by reference, described inter alia a kit that includes an extraction tube or a transport tube; a filter; a liquid for bathing the filter within the tube; and a filter shaft. The filter shaft includes a distal portion that is coupled to a central portion of the filter. The filter shaft is configured to insert the filter into the tube for bathing the filter in the liquid. PCT Publication WO 2024/013747 to Feldman et al., which is incorporated herein by reference, describes inter alia a filtration assembly that includes a tubular container shaped so as to define a proximal container opening for receiving a liquid specimen sample. A plunger includes a plunger head and a plunger rod, and is insertable into the tubular container via the proximal container opening. A filter support is shaped so as to define a support surface on which a filter is removably disposed, and a plurality of filtrate-passage openings through the filter support into a waste liquid receptacle. The filtration assembly is configured such that release of energy from a pre-loaded energy storage element, when the liquid specimen sample is contained in the tubular container and the filter is disposed on the support surface, pushes at least a portion of the liquid specimen sample through the filter and the filtrate-passage openings and into the waste liquid receptacle. US Patent Application Publication 2011/0318814 to Kshirsagar et al. describes inter alia a method for isolating microorganisms from a sample, the sample including sample matrix and microorganisms, the method including the steps of providing a receptacle, the receptacle configured to allow filtering of the sample and to reversibly contain the sample and a concentration agent; adding the sample to the receptacl