# US 2019/0167171 A1 · Aspirators with in-line colorimetric testers

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- Number: US 2019/0167171 A1
- Document ID: US20190167171A1
- Status: Published application
- Kind: A1
- Application number: 16/324,805
- Filed: 2017-08-14
- Published: 2019-06-06
- Earliest claimed: 2016-08-12
- Assignees: Nasogastric Feeding Colutions Ltd
- Applicants: Nasogastric Feeding Solutions Ltd
- Inventors: George GALLAGHER
- Web page: https://patentgrep.com/patent/US20190167171A1

## CPC

- A61B 5/14539: {for measuring pH}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/4238: {stomach}
- A61B 10/00: Instruments for taking body samples for diagnostic purposes (for taking samples of blood A61B5/15); Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
- A61B 10/0045: {Devices for taking samples of body liquids}
- A61J 15/0003: {Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth}
- A61J 15/0026: {Parts, details or accessories for feeding-tubes (external tubes from medical containers to a connector outside of the body A61M39/08)}
- A61J 15/008: {Sensor means, e.g. for sensing reflux, acidity or pressure (sensors for diagnostic purposes A61B5/00; sensors for inflation control A61M25/1018)}
- A61J 15/0084: {for sensing parameters related to the patient}
- A61M 1/73: {comprising sensors or indicators for physical values}
- A61M 1/772: {operating alternately}
- G01N 33/523: {the element being adapted for a specific analyte}
- A61B 5/6847: {mounted on an invasive device}
- A61B 2010/0061: {Alimentary tract secretions, e.g. biliary, gastric, intestinal, pancreatic secretions}
- A61B 2010/0083: {for taking gas samples}
- A61B 2010/0087: {Breath samples}
- A61B 2562/0295: Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
- A61M 2205/3324: PH measuring means
- A61M 2230/432: partial CO2 pressure (P-CO2)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

An in-line tester (100) comprising: an inlet (16), connectable, in use, to an aspirator tube (18); an outlet (20) connectable, in use, to a vacuum source (22); and a chamber (14) interposed between the inlet (16) and the outlet (20), the chamber (14) comprising: a first tester (108) arranged such that fluids drawn into the chamber (14) by the vacuum source (22) come into contact therewith; a second tester (122) arranged such that fluids drawn into the chamber (14) by the vacuum source (22) pass through it; and a reservoir (114) interposed between the first tester (108) and the second tester (122); wherein the first tester (108) comprises a first colorimetric substance adapted to exhibit a colour change in the presence of a target substance, and wherein the second tester (122) comprises colorimetric capnometer, which exhibits a colour change in the presence of carbon dioxide, the in-line tester (100) further comprising a liquid-stop device (52) which, when dry, permits the passage of gas from the inlet (16) to the outlet (20), but when wetted by a liquid, inhibits or prevents the passage of fluids from the inlet (16) to the outlet (20).

## Claims

### Claim at position 1

-37. (canceled)

### Claim 38

An in-line tester comprising:
an inlet, connectable, in use, to an aspirator tube;
an outlet connectable, in use, to a vacuum source; and
a chamber interposed between the inlet and the outlet, the chamber comprising:
a first tester comprising a first colorimetric substance adapted to exhibit a colour change in the presence of a target substance arranged such that fluids drawn into the chamber by the vacuum source come into contact therewith;
a second tester comprising a colorimetric capnometer, which exhibits a colour change in the presence of carbon dioxide arranged such that fluids drawn into the chamber by the vacuum source pass through it;
a reservoir interposed between the first tester and the second tester; and being characterised by:
the in-line tester further comprising a liquid-stop device which, when dry, permits the passage of gas from the inlet to the outlet, but when wetted by a liquid, inhibits or prevents the passage of fluids from the inlet to the outlet, and by:
the second tester being located downstream of the liquid-stop device and before the outlet.

### Claim 39 (depends on 38)

The in-line tester of claim 38, wherein the target substance comprises an acid, and wherein the colorimetric substance comprises an acid-base indicator.

### Claim 40 (depends on 39)

The in-line tester of claim 39, wherein the acid-base indicator comprises litmus paper, or bromothymol sulfonephthalein.

### Claim 41 (depends on 38)

The in-line tester of claim 38, wherein the target substance comprises a stomach-related marker being any one or more of the group comprising: a compound; a biological structure, such as a cell or a cell fragment; an enzyme; and a chemical, all of which are found within the stomach of a patient; and gastric enzyme; enzyme substrate; gastric lipase; gastric hormone; pepsin; pepsinogen; intrinsic factor (IF); vitamin B12-IF complex; mucin; gastrin; gastric lipase; and trypsin.

### Claim 42 (depends on 41)

The in-line tester of claim 41, wherein the target substance comprises gastric lipase and wherein the colorimetric substance comprises tributyrin, which detects metabolism of tributyrin by the colour change induced by production of butyric acid.

### Claim 43 (depends on 38)

The in-line tester of claim 38, comprising means for detecting the presence of two or more stomach-related markers, wherein the means for detecting the presence of two or more stomach-related markers are collocated on or in the first tester, wherein the first tester comprises a liquid-absorbent layer, which is divided into discrete regions, each discrete region comprising a different colorimetric substance adapted to exhibit a colour change in the presence of different target substances.

### Claim 44 (depends on 43)

The in-line tester of claim 43, wherein the liquid-absorbent layer comprises a first colorimetric substance adapted to exhibit a colour change, in use, according to the acidity/alkalinity of an aspirate drawn into the in-line tester; and further comprising a region of the liquid-absorbent layer comprising a second colorimetric substance adapted to produce an acid in the presence of a target stomach-related marker.

### Claim 45 (depends on 44)

The in-line tester of claim 44, wherein the liquid-absorbent layer comprises pH indicator paper, and wherein a region of the pH indicator paper is coated, or impregnated, with tributyrin, wherein in the presence of gastric lipase, the tributyrin produces alcohol and butyric acid, the butyric acid being able to interact with the pH indicator paper to cause its colour to correspond to an acidic pH reading.

### Claim 46 (depends on 38)

The in-line tester of claim 38, wherein the colorimetric capnometer comprises a paper substrate coated, or impregnated, with a dye that changes colour in the presence of carbon dioxide.

### Claim 47 (depends on 38)

The in-line tester of claim 38, wherein the colorimetric capnometer comprises a paper substrate coated, or impregnated, with a dye that changes colour in the presence of greater than 5% carbon dioxide.

### Claim 48 (depends on 38)

The in-line tester of claim 38, further comprising a one-way valve at, or downstream of, the outlet, wherein the cracking pressure for a given gas of the one-way valve is less than the pressure required to force the same gas through the liquid-stop device, such that when a positive gas pressure is applied at the outlet, gas is preferentially vented through the one-way valve, rather than back through the in-line tester.

### Claim 49 (depends on 38)

The in-line tester of claim 38, comprising a main body comprising two parts that fit together to form the chamber, the two parts each having a mutually cooperating mating surface, which when placed against the mating surface of the other part, forms a fluid-tight seal, wherein one or both of the two parts comprises recesses, grooves or other voids formed in their mating surface, the recesses, grooves or other voids forming internal chambers and fluid passageways of the in-line tester.

### Claim 50 (depends on 49)

The in-line tester of claim 49, further comprising an insert at least partially located within a chamber, the insert comprising an inlet which supports the first tester and a first vent aperture, the first vent aperture being arranged to direct a flow of gas passing through the in-line tester over the colorimetric capnometer.

### Claim 51 (depends on 38)

The in-line tester of claim 38, wherein the first or second tester and the liquid-stop device are in contact with one another, or are conjoined to form a laminated structure.

### Claim 52 (depends on 38)

The in-line tester of claim 38, wherein the liquid-stop device comprises a hydrophobic layer comprising pores or perforations that enable, when dry, air to pass through them but when wetted by liquid, the liquid is repelled from the surface of the hydrophobic layer and forced to overlie the openings of the pores or perforations.

### Claim 53 (depends on 52)

The in-line tester of claim 52, wherein the pores or perforations of the hydrophobic layer are smaller than the size of a liquid droplet.

### Claim 54 (depends on 38)

The in-line tester of claim 38, wherein the main body is at least partially manufactured of a transparent plastics material, and further comprising a colour chart corresponding to the or each colorimetric substance, the colour chart being affixed an exterior surface of a main body of the in-line tester, the colour chart being arranged so that a visual comparison of colour of the colorimetric substances to the respective parts of the colour chart can be made, the colour chart having a colour corresponding to a “fail” colour for each of the colorimetric tests, and comprising a through aperture registering with each of the colorimetric test strips such that if a “positive” test result is confirmed using any of the colorimetric test strips, the respective test trip/area will become visible, due to a difference in colour, compared with the regions of the colour chart surrounding each through aperture.

### Claim 55 (depends on 54)

The in-line tester of claim 54, wherein the “fail” colour is a different colour in different areas of the colour chart.

### Claim 56 (depends on 38)

The in-line tester of claim 38, wherein the liquid-stop device comprises a coarse liquid trap, and a fine liquid-stop device.

### Claim 57 (depends on 38)

The in-line tester of claim 38, wherein the liquid-stop device permits the passage of water vapour therethrough, but prevents or inhibits the passage of liquid drops therethrough.