# US 10,967,142 B1 · Systems and methods for tracking spontaneous breathing in a mechanically ventilated patient

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- Number: US 10,967,142 B1
- Document ID: US10967142B1
- Status: Granted
- Kind: B1
- Application number: 17/120,328
- Filed: 2020-12-14
- Published: 2021-04-01
- Granted: 2021-04-06
- Earliest claimed: 2017-09-20
- Assignees: ART MEDICAL Ltd.
- Applicants: ART MEDICAL Ltd.
- Inventors: Liron Elia; Gavriel J. Iddan
- Web page: https://patentgrep.com/patent/US10967142B1

## CPC

- A61M 16/024: {including calculation means, e.g. using a processor}
- A61B 5/037: {Measuring oesophageal pressure}
- A61B 5/1107: {Measuring contraction of parts of the body, e.g. organ or muscle}
- A61B 5/113: occurring during breathing
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/7257: {using Fourier transforms}
- A61J 15/0003: {Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth}
- A61J 15/0084: {for sensing parameters related to the patient}
- A61M 16/0003: {Accessories therefor, e.g. sensors, vibrators, negative pressure}
- A61M 16/021: {operated by electrical means (A61M16/202 – A61M16/205 take precedence)}
- A61M 16/022: {Control means therefor}
- A61M 16/026: {specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis}
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- A61B 5/6847: {mounted on an invasive device}
- A61J 15/0049: {Inflatable Balloons (balloon catheters A61M25/10)}
- A61J 15/0069: {Tubes feeding directly to the intestines, e.g. to the jejunum}
- A61M 16/0069: {the speed thereof being controlled by respiratory parameters, e.g. by inhalation}
- A61M 16/0434: {Cuffs}
- A61M 16/0463: {combined with suction tubes, catheters or the like; Outside connections}
- A61M 2016/0015: {inhalation detectors}
- A61M 2016/0018: {electrical}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0033: {electrical}
- A61M 2039/085: {external enteral feeding tubes}
- A61M 2202/0482: Enteral feeding product
- A61M 2205/33: Controlling, regulating or measuring
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2210/1014: Diaphragm
- A61M 2210/1025: Respiratory system (A61M2210/0618 take precedence)
- A61M 2210/105: Oesophagus
- A61M 2210/1053: Stomach
- A61M 2230/08: Other bio-electrical signals
- A61M 2230/40: Respiratory characteristics
- A61M 2230/42: Rate
- A61M 2230/65: Impedance, e.g. conductivity, capacity
- 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)
- 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
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

There is provided system for monitoring spontaneous breathing of a mechanically ventilated target individual, including: a feeding tube for insertion into a distal end of an esophagus of the individual, sensor(s) disposed on the feeding tube at a location such that the sensor(s) is located at the distal end of the esophagus of the individual when the feeding tube is in use, wherein the sensor(s) is positioned for sensing values by contact with the tissue of the esophagus including a lower esophageal sphincter (LES) and/or tissue in proximity to the LES, and code for computing an indication of a frequency band of diaphragm movement of the individual according to an analysis of values sensed by the sensor(s), and for adjustment of parameter(s) of a mechanical ventilator for mechanically ventilating the individual, wherein the instructions for adjustment are computed while the feeding tube is in use.

## Claims

### Claim 1

A system for mechanically ventilating a target individual, the system comprising:
a probe for insertion into a distal end of an esophagus of the mechanically ventilated target individual;
at least one sensor comprising at least one electrode for sensing impedance values disposed near a distal end of the probe at a location such that the at least one electrode is located at the distal end of the esophagus of the target individual when the probe is located within the esophagus and in use, wherein the at least one electrode is positioned for sensing impedance values when contacting tissue of the esophagus including at least one of a lower esophageal sphincter (LES) and tissue in proximity to the LES; and
a non-transitory memory having stored thereon a code that in response to execution by at least one hardware processor of a computing device, causes the computing device to extract a frequency band of diaphragm movement and a phase of the diaphragm movement of the mechanically ventilated target individual from the impedance values sensed by the at least one electrode that include much larger amplitude signals generated based on a mechanical ventilator, and compute instructions to adjust ventilation frequencies and ventilation phases of the mechanical ventilator for mechanically ventilating the target individual by synchronizing to a wave form of the diaphragm movement in frequency band and phase of diaphragm movement for matching a waveform of the ventilator to the waveform of the diaphragm movement.

### Claim 2 (depends on 1)

The system of claim 1, wherein the probe comprises a nasogastric tube for evacuation of contents from the stomach.

### Claim 3 (depends on 1)

The system of claim 1, wherein the frequency band of diaphragm movement of the mechanically ventilated target individual is within the range having a lower cutoff of greater than 0.2 Hz and a higher cutoff of about 0.5 Hz.

### Claim 4

A system for mechanically ventilating a target individual, the system comprising:
a probe for insertion into a distal end of an esophagus of the mechanically ventilated target individual;
at least one pressure sensor set for sensing pressure values near a distal end of the probe at least at one of a lower esophageal sphincter (LES) and tissue in proximity to the LES when the probe is located within the esophagus,
wherein pressure values sensed by the pressure sensor include pressure changes created by the movement of the diaphragm; and
a non-transitory memory having stored thereon a code that in response to execution by at least one hardware processor of a computing device, causes the computing device to extract a frequency band of diaphragm movement and a phase of the diaphragm movement of the mechanically ventilated target individual from the pressure values sensed by the at least one pressure sensor that include much larger amplitude signals generated based on a mechanical ventilator, and compute instructions to adjust ventilation frequencies and ventilation phases of the mechanical ventilator for mechanically ventilating the target individual by synchronizing to a wave form of the diaphragm movement in frequency band and phase of diaphragm movement for matching a waveform of the ventilator to the waveform of the diaphragm movement.

### Claim 5 (depends on 4)

The system according to claim 4, further comprising:
at least one esophageal body having a pressure dependent volume, coupled to a distal portion of the probe, wherein the at least one esophageal body contacts the tissue of the esophagus at least one of: at the LES, and in proximity to the LES, when inflated,
wherein the at least one pressure sensor that senses the pressure in the at least one esophageal body when inflated.

### Claim 6 (depends on 5)

The system according to claim 5, wherein the pressure values sensed by the at least one pressure sensor includes esophageal wall pressure changes.

### Claim 7 (depends on 5)

The system according to claim 5, wherein the pressure values sensed by the at least one pressure sensor include breathing pressure.

### Claim 8 (depends on 5)

The system of claim 5, wherein the at least one pressure sensor senses pressure changes created by movement of the diaphragm in air located in the esophagus.

### Claim 9 (depends on 8)

The system of claim 8, wherein the at least one pressure sensor includes a miniature pressure sensor mounted on the probe at least one of: at the LES, and in proximity to the LES, when the probe is located in the esophagus.

### Claim 10 (depends on 5)

The system according to claim 5, further comprising code that in response to execution by at least one hardware processor of the computing device, causes the computing device to compute a Fourier transform of a current signal indicative of current values sensed by the at least one pressure sensor, identify a maximum value of the Fourier transform, and compute the frequency of diaphragm movement according to the frequency and amplitude corresponding to the maximum value.

### Claim 11 (depends on 5)

The system according to claim 5, further comprising code that in response to execution by at least one hardware processor of the computing device, causes the computing device to compute a band pass filter based on values sensed by the at least one pressure sensor during a historical time interval, the band pass filter computed according to a frequency and phase corresponding to a maximum value computed from a Fourier transform of the pressure values obtained during a historical time interval, and according to a frequency bandwidth based on the maximum value, and apply the filter to the current signal indicative of pressure values to compute the frequency band and phase of diaphragm movement.

### Claim 12

A computing device for converting electrical signals including an indication of diaphragm movement to instructions for operating a mechanical ventilator mechanically ventilating a target individual, the computing device comprising:
a probe for insertion into a distal end of an esophagus of the mechanically ventilated target individual;
at least one sensor comprising at least one electrode for sensing impedance values disposed near a distal end of the probe at a location such that the at least one electrode is located at the distal end of the esophagus of the target individual when the probe is located within the esophagus and in use, wherein the at least one electrode is positioned for sensing impedance values when contacting tissue of the esophagus including at least one of a lower esophageal sphincter (LES) and tissue in proximity to the LES; and
at least one hardware processor executing a code for: extracting a frequency band of diaphragm movement and a phase of the diaphragm movement of the mechanically ventilated target individual from the electrical signals including the indication of diaphragm movement, the signals including much larger amplitude signals generated based on the mechanical ventilator, and computing instructions to adjust ventilation frequencies and ventilation phases of the mechanical ventilator for mechanically ventilating the target individual by synchronizing to a wave form of the diaphragm movement in frequency band and phase of diaphragm movement for matching a waveform of the ventilator to the waveform of the diaphragm movement.

### Claim 13 (depends on 12)

The computing device according to claim 12, wherein the mechanical ventilator is a conventional mechanical ventilator that ventilates the target individual at a frequency within a normal respiratory rate.

### Claim 14 (depends on 12)

The computing device according to claim 12, wherein the electrical signals are received via an interface from an external device and/or external sensor.

### Claim 15 (depends on 14)

The computing device according to claim 14, wherein the interface is selected from a group consisting of: a wire connection, a wireless connection, a network interface, an application programming interface (API), and a software development kit (SDK).

### Claim 16 (depends on 12)

The computing device according to claim 12, wherein the instructions are outputted to the mechanical ventilator via an interface.

### Claim 17 (depends on 16)

The computing device according to claim 16, wherein the interface is selected from a group consisting of: a wire connection, a wireless connection, a network interface, and a physical port.

### Claim 18 (depends on 12)

The computing device according to claim 12, wherein the computing device is implemented as a standalone device that is connected to an external device and/or external sensor for receiving the electrical signals, and is connected to the mechanical ventilator for providing the instructions.

### Claim 19 (depends on 12)

The computing device according to claim 12, wherein the computing device is implemented as a server and/or in a computing cloud that is connected to an external device and/or external sensor via a network for receiving the electrical signals, and is connected to the mechanical ventilator via the network for providing the instructions.