# US 10,307,341 B2 · Medical tube position confirmation device

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- Number: US 10,307,341 B2
- Document ID: US10307341B2
- Status: Granted
- Kind: B2
- Application number: 15/440,933
- Filed: 2017-02-23
- Published: 2017-08-24
- Granted: 2019-06-04
- Earliest claimed: 2016-02-23
- Assignees: NGPod Global Limited
- Applicants: NGPod Global Limited
- Inventors: David Raymond Small; John Davies
- Web page: https://patentgrep.com/patent/US10307341B2

## CPC

- A61J 15/0088: {for sensing parameters related to the device}
- A61B 5/0084: {for introduction into the body, e.g. by catheters (A61B5/1459 takes precedence)}
- A61B 5/14507: {specially adapted for measuring characteristics of body fluids other than blood (devices for taking samples of body liquids A61B10/0045)}
- A61B 5/14539: {for measuring pH}
- A61B 5/1459: invasive, e.g. introduced into the body by a catheter
- A61B 5/6871: {Stomach}
- A61J 15/0003: {Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth}
- G01N 21/7703: {using reagent-clad optical fibres or optical waveguides (using measurement of total internal reflection or attenuated total reflection G01N21/552; optical fibres or waveguides per se G02B)}
- G01N 21/78: producing a change of colour
- G02B 6/02033: {Core or cladding made from organic material, e.g. polymeric material (G02B1/04 takes precedence)}
- G02B 6/262: {Optical details of coupling light into, or out of, or between fibre ends, e.g. special fibre end shapes or associated optical elements}
- G02B 6/4415: {Cables for special applications (G02B6/4429, G02B6/4439, G02B6/4479 take precedence)}
- A61B 2562/12: Manufacturing methods specially adapted for producing sensors for in-vivo measurements
- A61J 15/0069: {Tubes feeding directly to the intestines, e.g. to the jejunum}
- G01N 21/80: Indicating pH value
- 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
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- G02B: OPTICAL ELEMENTS, SYSTEMS OR APPARATUS

## Abstract

A feeding tube position confirmation device 102, operable to confirm the position of a predetermined portion of a medical feeding tube in a predetermined portion of a human or animal body, the position confirmation device comprising an optical waveguide 106 dimensioned to be insertable into the lumen of the feeding tube, the optical waveguide having a sensing distal end 108 comprising a distal end material and a sensing material mixed with the distal end material, the sensing material operable to provide a change in optical properties at the distal end 110 of the optical waveguide dependent on the environment to which the sensing distal end 108 of the waveguide is exposed. The sensing material may comprise a reflective material. Methods of manufacture and use of such devices are also described.

## Claims

### Claim 1

A feeding tube position confirmation device, operable to confirm the position of a predetermined portion of a medical feeding tube in a predetermined portion of a human or animal body, the position confirmation device comprising an optical waveguide dimensioned to be insertable into the lumen of said feeding tube, the optical waveguide having a sensing distal end comprising a sensing material operable to provide a change in optical properties at the distal end of the optical waveguide dependent on the environment to which the sensing distal end of the waveguide is exposed, wherein the sensing material comprises an optical indicator and a reflective material, wherein the optical indicator and the reflective material are mixed with a hydrophilic polyurethane.

### Claim 2 (depends on 1)

A device according to claim 1, wherein the sensing material is operable to change to a predetermined colour color dependent on the environment to which the sensing distal end of the waveguide is exposed.

### Claim 3 (depends on 1)

A device according to claim 1, wherein the sensing material comprises a chemical or biological indicator and the chemical or biological indicator comprises at least one of: Thymol Blue, Methyl Red, Bromothymol Blue, Phenolphthalein, Bromocresol green, Fluorescein, Ether, and Universal Indicator.

### Claim 4 (depends on 1)

A device according to claim 1, wherein the reflective material is titanium dioxide.

### Claim 5 (depends on 1)

A device according to claim 1, wherein the sensing distal end of the optical waveguide is formed by coating the distal end of an optical waveguide with the sensing material, transforming the coated distal end into a fluid state such that the sensing material and distal end material are mixed with each other and then transforming the material into a solid state to form the sensing distal end.

### Claim 6 (depends on 1)

A device according to claim 1, wherein the optical waveguide comprises an optical sensor at the proximal end of the optical waveguide operable to detect the change in optical properties at the distal end of the optical waveguide.

### Claim 7 (depends on 1)

A medical feeding tube position confirmation kit comprising a medical feeding tube and at least one feeding tube position confirmation device as claimed in claim 1.

### Claim 8 (depends on 1)

A medical feeding tube position confirmation system comprising a device as claimed in claim 1 and a control unit operable to control the device.

### Claim 9 (depends on 1)

A method for confirming the position of a placed feeding tube, comprising: disposing a feeding tube position confirmation device according to claim 1 in a pre-positioned medical feeding tube; providing an optical sensor at a proximal end of the feeding tube position confirmation device, the optical sensor operable to detect a change in optical properties at the distal end of the optical waveguide, advancing the position of the distal end of the optical waveguide, monitoring an output from the optical sensor to detect a signal indicative of a change in optical properties of the sensing material at the distal end of the optical waveguide and determining whether the signal matches one or more predetermined characteristics indicative of a desired position of the sensing distal end.
