# US 2022/0032010 A1 · Airway Detection Using Ultrasound

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- Number: US 2022/0032010 A1
- Document ID: US20220032010A1
- Status: Published application
- Kind: A1
- Application number: 16/944,696
- Filed: 2020-07-31
- Published: 2022-02-03
- Earliest claimed: 2020-07-31
- Assignees: Avent, Inc.
- Applicants: Avent, Inc.
- Inventors: Karl Thomas Bjurbo; James F. Tassitano; David M. Page; Hilton M. Kaplan; Don J. McMichael
- Web page: https://patentgrep.com/patent/US20220032010A1

## CPC

- A61M 25/0158: {with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/42: {Details of probe positioning or probe attachment to the patient}
- A61B 8/4254: {using sensors mounted on the probe}
- A61B 8/445: {Details of catheter construction}
- A61B 8/5207: {involving processing of raw data to produce diagnostic data, e.g. for generating an image}
- A61B 8/56: {Details of data transmission or power supply}
- A61B 8/085: {for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules}
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2210/1025: Respiratory system (A61M2210/0618 take precedence)
- A61M 2210/1042: Alimentary tract (A61M2210/0618 takes precedence)
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A tubing assembly for use with electronic catheter guidance systems is provided and includes a catheter, an ultrasound transducer disposed within the catheter, and an optional additional external ultrasound transducer. The catheter extends in a longitudinal direction and has a proximal end and a distal end defining a lumen therebetween. Further, the catheter is configured for placement within a patient's digestive tract or respiratory tract. The ultrasound transducer can be located within the catheter's lumen, and the optional external ultrasound transducer can be located on or outside the patient's body. Both ultrasound transducers can transmit ultrasound signals as directed by a processor and can communicate with the processor to deliver ultrasound data to a display device. The attenuation of the ultrasound energy at a selected frequency can indicate placement of the catheter in the digestive tract or respiratory tract. A catheter guidance system and method of use are also provided.

## Claims

### Claim 1

A tubing assembly comprising:
a catheter having a proximal end and a distal end and extending in a longitudinal direction, wherein the proximal end and the distal end define a lumen therebetween, and wherein the catheter is configured for placement within a digestive tract of a patient; and
an ultrasound transducer.

### Claim 2 (depends on 1)

The tubing assembly of claim 1, wherein the ultrasound transducer is located within the lumen of the catheter.

### Claim 3 (depends on 1)

The tubing assembly of claim 1, wherein the ultrasound transducer is located at the distal end of the catheter.

### Claim 4 (depends on 1)

The tubing assembly of claim 1, wherein the ultrasound transducer is configured to transmit ultrasound energy as controlled by a processor in real-time.

### Claim 5 (depends on 4)

The tubing assembly of claim 4, wherein the ultrasound transducer is configured for a wired connection or a wireless connection to the processor.

### Claim 6 (depends on 4)

The tubing assembly of claim 4, wherein the ultrasound transducer is further configured to receive ultrasound energy and send sign related to the received ultrasound energy to the processor.

### Claim 7 (depends on 1)

The tubing assembly of claim 1, wherein the ultrasound transducer comprises a piezoelectric component.

### Claim 8

A catheter guidance system comprising:
(a) a processor;
(b) a power source; and
(c) a tubing assembly comprising:
a catheter having a proximal end and a distal end and extending in a longitudinal direction, wherein the proximal end and the distal end define a lumen therebetween; and
an ultrasound transducer;
wherein the ultrasound transducer transmits and/or receives ultrasound energy as controlled by the processor in real-time via an electrical connection;
wherein ultrasound data from the ultrasound transducer is communicated to the processor in real-time via an electrical connection;
wherein the catheter guidance system alerts a user as to placement of the catheter in a digestive tract of a patient or alerts the user as to placement of the catheter in a respiratory tract of the patient.

### Claim 9 (depends on 8)

The catheter guidance system of claim 8, further comprising a memory device storing instructions which, when executed by the processor, cause the processor to (i) interpret the ultrasound data communicated to the processor and (ii) cause the catheter guidance system to alert the user as to placement of the catheter in the digestive tract of the patient or alert the user as to placement of the catheter in the respiratory tract of the patient based on the interpretation of the ultrasound data.

### Claim 10 (depends on 9)

The catheter guidance system of claim 9, wherein the processor interprets the ultrasound data by determining a degree of attenuation of ultrasound signals, time-of-flight of ultrasound signals, or ultrasound imaging.

### Claim 11 (depends on 10)

The catheter guidance system of claim 10, wherein the degree of attenuation of ultrasound energy delivered at a frequency of about 20 kilohertz to about 2.5 megahertz is used to determine if the placement of the catheter is in the digestive tract or the respiratory tract.

### Claim 12 (depends on 8)

The catheter guidance system of claim 8, wherein the ultrasound transducer is located within the lumen of the catheter at the distal end of the catheter.

### Claim 13 (depends on 8)

The catheter guidance system of claim 8, wherein the ultrasound transducer comprises a piezoelectric component.

### Claim 14 (depends on 8)

The catheter guidance system of claim 8, wherein the system further comprises an external ultrasound transducer configured to transmit ultrasound energy to the ultrasound transducer of the tubing assembly and/or receive ultrasound energy transmitted by the ultrasound transducer of the tubing assembly.

### Claim 15 (depends on 14)

The catheter guidance system of claim 14, wherein the external ultrasound transducer is configured to be placed on or near the patient's throat or chest.

### Claim 16

A method for determining if a catheter is placed within a digestive tract of a body of a patient, the method comprising:
(a) inserting a distal end of a tubing assembly into an orifice of the body, wherein the tubing assembly comprises:
the catheter, wherein the catheter has a proximal end and a distal end and extends in a longitudinal direction, wherein the proximal end and the distal end define a lumen therebetween; and
an ultrasound transducer;
(b) electrically connecting the ultrasound transducer to a processor via a wired connection or a wireless connection;
(c) activating the ultrasound transducer, wherein the ultrasound transducer transmits and/or receives ultrasound energy as controlled by the processor in real-time via an electrical connection;
(d) advancing the distal end of the catheter inside the body in a direction away from the orifice while the ultrasound transducer is activated;
(f) communicating ultrasound data from the ultrasound transducer to the processor in real-time via the wired connection or the wireless connection; and
(g) informing a user as to placement of the catheter in the digestive tract of the patient or respiratory tract of the patient based on the ultrasound data received by the processor.

### Claim 17 (depends on 16)

The method of claim 16, wherein a memory device stores instructions which, when executed by the processor, cause the processor to (i) interpret the ultrasound data communicated to the processor and (ii) cause a display device to communicate whether or not the catheter is placed within the digestive tract of the patient based on the interpretation of the ultrasound data.

### Claim 18 (depends on 17)

The method of claim 17, wherein the processor interprets the ultrasound data by determining a degree of attenuation of ultrasound signals, time-of-flight of ultrasound signals, or ultrasound imaging.

### Claim 19 (depends on 18)

The method of claim 18, wherein the degree of attenuation of ultrasound energy delivered at a frequency of about 20 kilohertz to about 2.5 megahertz is used to determine if the placement of the catheter is in the digestive tract or the respiratory tract.

### Claim 20 (depends on 16)

The method of claim 16, further comprising steps of placing an external ultrasound transducer on or near the patient's body, wherein the external ultrasound transducer is electrically connected to the processor via a wired connection or a wireless connection; and activating the external ultrasound transducer to transmit ultrasound energy and/or receive ultrasound energy transmitted by the ultrasound transducer of the tubing assembly.

### Claim 21 (depends on 20)

The method of claim 20, wherein the frequency and intensity of the ultrasound energy transmitted by the ultrasound transducer of the tubing assembly and/or the external ultrasound transducer is selected to be detectable by the other of the ultrasound transducer of the tubing assembly or the external ultrasound transducer when the ultrasound transducer of the tubing assembly is located in the digestive tract and not detectable by the other of the ultrasound transducer of the tubing assembly or the external ultrasound transducer when the ultrasound transducer of the tubing assembly is located in the respiratory tract.

### Claim 22 (depends on 20)

The method of claim 20, wherein the processor is configured to measure attenuation of the transmitted ultrasound energy.
