# US 11,304,877 B2 · Method and apparatus for assisting, checking, and confirming nasogastric and orogastric tube insertion and placement

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- Number: US 11,304,877 B2
- Document ID: US11304877B2
- Status: Granted
- Kind: B2
- Application number: 17/331,966
- Filed: 2021-05-27
- Published: 2021-12-02
- Granted: 2022-04-19
- Earliest claimed: 2020-05-27
- Applicants: Glenn Gerald Strawder
- Inventors: Glenn Gerald Strawder
- Web page: https://patentgrep.com/patent/US11304877B2

## CPC

- A61J 15/0007: {inserted by using a guide-wire (guide wires A61M25/09)}
- A61J 15/0026: {Parts, details or accessories for feeding-tubes (external tubes from medical containers to a connector outside of the body A61M39/08)}
- 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 5/4238: {stomach}
- A61B 5/6847: {mounted on an invasive device}
- A61B 5/6871: {Stomach}
- A61J 15/0003: {Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth}
- A61J 15/0073: {Multi-lumen tubes}
- A61J 15/0084: {for sensing parameters related to the patient}
- A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00})
- A61B 5/065: {Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe}
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- 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)
- 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)}

## Abstract

A long, thin, flexible medical apparatus, a kit including such an apparatus, and a method for employing the apparatus to assist in placing a distal portion of a lumen of a gastric tube in a stomach of a mammal. The apparatus comprises an elongate body portion, a handle portion fixed to a proximal end of the body portion, and a distal tip portion fixed to a distal end of the body portion. An ability to insert the body and distal tip portions into the gastric tube over the length of the long, thin, flexible structure provides a positive indication that the lumen is not blocked, obstructed, or otherwise compromised over that length. pH indicator sensors may be retained by the distal tip portion to exhibit a verifiable color change in response to contact with a predetermined subject fluid, such as gastric fluid, lung fluid, or another bodily fluid.

## Claims

### Claim 1

A kit for assisting in, checking, and confirming placement of a distal portion of a lumen of a gastric tube in a stomach of a mammal, the kit comprising:
a gastric tube comprising a lumen with an entrance, a passageway, and a distal portion;
a long, thin, flexible medical apparatus comprising an elongate body portion of flexible material, the body portion with a proximal end and a distal end, a handle portion fixed to the proximal end of the body portion, a distal tip portion fixed to the distal end of the body portion wherein the body portion and the distal tip portion together form a long, thin, flexible structure with a length for being selectively received into the passageway of the lumen of the gastric tube, and a pH indicator sensor array retained by the long, thin, flexible structure formed by the body portion and the distal tip portion wherein the pH indicator sensor array comprises a first pH indicator sensor with a pH indicator calibrated to exhibit a verifiable response to contact with a predetermined subject fluid;
wherein the long, thin, flexible medical apparatus is adapted for being selectively inserted into and removed from the passageway of the lumen of the gastric tube whereby an ability to insert the body portion and the distal tip portion into the passageway in the lumen of the gastric tube over the length of the long, thin, flexible structure provides a positive indication that the lumen is not blocked, obstructed, or otherwise compromised over the length of the long, thin, flexible structure and whereby, when the long, thin, flexible medical apparatus is inserted into and removed from the passageway of the lumen of the gastric tube, the verifiable response or lack of the verifiable response of the pH indicator will positively indicate whether the pH indicator sensor has made contact with the predetermined subject fluid.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the distal tip portion of the apparatus has rigidity sufficient, when received into the distal portion of the lumen of the gastric tube, to facilitate passage of the distal portion of the lumen during insertion into the mammal.

### Claim 3 (depends on 1)

The kit of claim 1, wherein the body portion and the distal tip portion of the apparatus have lateral dimensions sufficient to prevent retraction of the body portion and the distal tip portion when the body portion and the distal tip portion have been received into the lumen of the gastric tube and a compromise develops in the lumen of the gastric tube along the length of the long, thin, flexible structure.

### Claim 4 (depends on 1)

The kit of claim 1, wherein the first pH indicator sensor is calibrated to exhibit a verifiable color change in response to contact with gastric fluid.

### Claim 5 (depends on 1)

The kit of claim 1, wherein the first pH indicator sensor is calibrated to exhibit a verifiable color change in response to contact with lung fluid.

### Claim 6 (depends on 1)

The kit of claim 1, wherein the pH indicator sensor array retained by the long, thin flexible structure further comprises a second pH indicator sensor with a pH indicator calibrated to exhibit a verifiable color change in response to contact with a predetermined subject fluid.

### Claim 7 (depends on 6)

The kit of claim 6, wherein the first and second pH indicator sensors are calibrated to exhibit a verifiable color change in response to contact with the same predetermined subject fluid.

### Claim 8 (depends on 7)

The kit of claim 7, wherein the first and second pH indicator sensors are calibrated to exhibit a verifiable color change in response to contact with the same predetermined subject fluid comprising gastric fluid.

### Claim 9 (depends on 7)

The kit of claim 7, wherein the first and second pH indicator sensors are calibrated to exhibit a verifiable color change in response to contact with different predetermined subject fluids.

### Claim 10 (depends on 9)

The kit of claim 9, wherein the first pH indicator sensor is calibrated to exhibit a verifiable color change in response to contact with gastric fluid and wherein the second pH indicator sensor is calibrated to exhibit a verifiable color change in response to contact with lung fluid.

### Claim 11 (depends on 1)

The kit of claim 1, wherein the pH indicator sensor array retained by the long, thin flexible structure comprises a plurality of pH indicator sensors, each with a pH indicator calibrated to exhibit a verifiable color change in response to contact with a predetermined subject fluid, wherein the plurality of pH indicator sensors are spaced in longitudinal alignment along the long, thin, flexible structure.

### Claim 12 (depends on 1)

The apparatus of claim 1, further comprising measurement markings disposed along the long, thin, flexible structure.

### Claim 13 (depends on 12)

The apparatus of claim 12, wherein the measurement markings descend along the long, thin, flexible structure from a highest number is disposed adjacent to the proximal end of the body portion.

### Claim 14 (depends on 1)

The apparatus of claim 1, further comprising at least one notch in the long, thin, flexible structure wherein the at least one notch demonstrates decreased resistance to flexion in comparison to segments of the long, thin, flexible structure disposed adjacent to the notch.

### Claim 15 (depends on 1)

The apparatus of claim 1, further comprising at least one longitudinal reinforcing rib disposed on the long, thin, flexible structure wherein the reinforcing rib increases the local thickness and rigidity of the long, thin, flexible structure.

### Claim 16 (depends on 1)

The kit of claim 1, wherein the body portion comprises an elongate core surrounded by a sheath.

### Claim 17

A kit for assisting in, checking, and confirming placement of a distal portion of a lumen of a gastric tube in a stomach of a mammal, the kit comprising:
a gastric tube comprising a lumen with an entrance, a passageway, and a distal portion;
a long, thin, flexible medical apparatus for being selectively inserted into and removed from the passageway of the lumen of the gastric tube, the long, thin, flexible medical apparatus comprising:
an elongate body portion of flexible material, the body portion with a proximal end and a distal end;
a handle portion fixed to the proximal end of the body portion; and
a distal tip portion fixed to the distal end of the body portion wherein the body portion and the distal tip portion together form a long, thin, flexible structure with a length for being selectively received into the passageway of the lumen of the gastric tube;
wherein the body portion and the distal tip portion of the apparatus have lateral dimensions sufficient to prevent passage of the body portion and the distal tip portion past a blockage, obstruction, or other compromise in the lumen of the gastric tube and wherein the body portion and the distal tip portion of the apparatus have lateral dimensions sufficient to prevent retraction of the body portion and the distal tip portion when the body portion and the distal tip portion have been received into the lumen of the gastric tube and a compromise develops in the lumen of the gastric tube along the length of the long, thin, flexible structure;
whereby an ability to insert and withdraw the body portion and the distal tip portion in relation to the passageway in the lumen of the gastric tube over the length of the long, thin, flexible structure provides a positive indication that the lumen is not blocked, obstructed, or otherwise compromised over the length of the long, thin, flexible structure.

### Claim 18 (depends on 17)

The kit of claim 17, wherein the distal tip portion of the apparatus has rigidity sufficient, when received into the distal portion of the lumen of the gastric tube, to facilitate passage of the distal portion of the lumen during insertion into the mammal.

### Claim 19 (depends on 17)

The kit of claim 17, further comprising a pH indicator sensor array retained by the long, thin, flexible structure formed by the body portion and the distal tip portion wherein the pH indicator sensor array comprises a first pH indicator sensor with a pH indicator.

### Claim 20 (depends on 19)

The kit of claim 19, wherein the first pH indicator sensor is calibrated to exhibit a verifiable color change in response to contact with a predetermined subject fluid.

### Claim 21 (depends on 20)

The kit of claim 20, wherein the first pH indicator sensor is calibrated to exhibit a verifiable color change in response to contact with gastric fluid.

### Claim 22 (depends on 20)

The kit of claim 20, wherein the first pH indicator sensor is calibrated to exhibit a verifiable color change in response to contact with lung fluid.

### Claim 23 (depends on 19)

The kit of claim 19, wherein the pH indicator sensor array retained by the long, thin flexible structure further comprises a second pH indicator sensor with a pH indicator calibrated to exhibit a verifiable color change in response to contact with a predetermined subject fluid.

### Claim 24 (depends on 23)

The kit of claim 23, wherein the first and second pH indicator sensors are calibrated to exhibit a verifiable color change in response to contact with the same predetermined subject fluid.

### Claim 25 (depends on 24)

The kit of claim 24, wherein the first and second pH indicator sensors are calibrated to exhibit a verifiable color change in response to contact with gastric fluid.

### Claim 26 (depends on 23)

The kit of claim 23, wherein the first and second pH indicator sensors are calibrated to exhibit a verifiable color change in response to contact with different predetermined subject fluids.

### Claim 27 (depends on 26)

The kit of claim 26, wherein the first pH indicator sensor is calibrated to exhibit a verifiable color change in response to contact with gastric fluid and wherein the second pH indicator sensor is calibrated to exhibit a verifiable color change in response to contact with lung fluid.

### Claim 28 (depends on 1)

The kit of claim 1, wherein the pH indicator sensor array retained by the long, thin flexible structure further comprises a plurality of pH indicator sensors, each with a pH indicator calibrated to exhibit a verifiable color change in response to contact with a predetermined subject fluid, wherein the plurality of pH indicator sensors are spaced along the long, thin, flexible structure.

### Claim 29 (depends on 28)

The kit of claim 28, wherein the distal portion of the lumen of the gastric tube has a plurality of openings spaced therein and wherein the plurality of pH indicator sensors of the pH indicator sensor array are disposed to align with the plurality of openings in the distal portion of the gastric tube when the long, thin, flexible structure is inserted into the lumen of the gastric tube whereby the long, thin, flexible structure can be inserted into the lumen of the gastric tube to cause the plurality of pH indicator sensors of the pH indicator sensor array to align with the plurality of openings in the distal portion of the gastric tube and whereby the long, thin, flexible medical structure can be completely removed from the lumen of the gastric tube to obtain the verifiable color change or lack of the verifiable color change of the plurality of pH indicator sensors of the pH indicator sensor array to indicate whether the pH indicator sensors have made contact with the predetermined subject fluid.

### Claim 30 (depends on 17)

The kit of claim 17, wherein the passageway of the lumen of the gastric tube has a length and wherein the length of the long, thin, flexible structure formed by the body portion and the distal tip portion does not exceed the length of the passageway of the lumen.

### Claim 31 (depends on 30)

The kit of claim 30, wherein the length of the long, thin, flexible structure formed by the body portion and the distal tip portion is approximately equal to the length of the passageway of the lumen whereby an ability to insert the body portion and the distal tip portion of the long, thin, flexible medical apparatus into the passageway in the lumen of the gastric tube over the length of the long, thin, flexible structure provides a positive indication that the lumen is not blocked, obstructed, or otherwise compromised over the length of the long, thin, flexible structure and over the length of the passageway of the lumen.

### Claim 32 (depends on 31)

The kit of claim 31, further comprising measurement markings disposed along the long, thin, flexible structure.

### Claim 33 (depends on 29)

The kit of claim 29, wherein the plurality of pH indicator sensors are spaced in longitudinal alignment along the long, thin, flexible structure.