# US 11,298,485 B2 · Esophageal pressure clinical decision support system

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- Number: US 11,298,485 B2
- Document ID: US11298485B2
- Status: Granted
- Kind: B2
- Application number: 16/514,270
- Filed: 2019-07-17
- Published: 2021-01-21
- Granted: 2022-04-12
- Earliest claimed: 2019-07-17
- Assignees: Convergent Engineering, Inc.
- Applicants: Convergent Engineering, Inc.
- Inventors: Neil Russell Euliano, II
- Web page: https://patentgrep.com/patent/US11298485B2

## CPC

- A61M 16/024: {including calculation means, e.g. using a processor}
- A61B 5/0037: {Performing a preliminary scan, e.g. a prescan for identifying a region of interest}
- A61B 5/037: {Measuring oesophageal pressure}
- A61B 5/087: Measuring breath flow
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)}
- A61M 16/04: Tracheal tubes (catheters in general A61M25/00)
- G16H 40/60: for the operation of medical equipment or devices
- A61B 2505/03: Intensive care
- A61B 2505/05: Surgical care
- A61M 16/0066: {Blowers or centrifugal pumps}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0033: {electrical}
- A61M 2205/18: with alarm
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/6081: Colour codes
- A61M 2210/105: Oesophagus
- A61M 2230/04: Heartbeat characteristics, e.g. ECG, blood pressure modulation
- A61M 2230/20: Blood composition characteristics
- A61M 2230/30: Blood pressure (A61M2230/04 takes precedence)
- A61M 2230/42: Rate
- A61M 2230/432: partial CO2 pressure (P-CO2)
- A61M 2230/435: partial O2 pressure (P-O2)
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A novel clinical decision support system (CDS) helps the clinician setup, maintain, and interpret esophageal pressure measurement. The esophageal pressure CDS (Pes CDS) would remind the clinician to do an occlusion test whenever the balloon is first inserted or changes dramatically. It could monitor the occlusion test and provide feedback on the performance and success of the occlusion test. Changes in the patient or monitored data can be tracked by looking for changes in the balloon baseline pressure, changes in the amplitude of the pressure waveform, or changes in the pattern of the Pes waveform. Having information from the ventilator will further increase the ability of the system to determine when Pes is changing unexpectedly.

## Claims

### Claim 1

A system to improve operation of a ventilator comprising:
two or more sensors to provide measurement data for each of esophageal pressure data, airway pressure data, and airway flow data from a patient being ventilated;
a processor electronically coupled to the sensors and receiving the measurement data therefrom, the processor continuously compares the esophageal pressure data with changes to both the airway pressure data and the air flow data to determine an accuracy of the esophageal pressure data; and
displaying, on a display, an automatic accuracy indicator to indicate a reliability of the esophageal pressure data.

### Claim 2 (depends on 1)

The system of claim 1, wherein the accuracy of the esophageal pressure data is determined by automatically comparing the airway pressure data to the esophageal pressure data during one or more of a trigger portion of a breath, an end exhalation portion of a breath, or an end inspiratory pause of a breath from the patient being ventilated.

### Claim 3 (depends on 2)

The system of claim 2, wherein the automatically comparing occurs over multiple breaths from the patient being ventilated and the processor further determines a trend that is included in the accuracy of the esophageal pressure data.

### Claim 4 (depends on 1)

The system of claim 1,
wherein the display indicates a status that is used as part of a clinical decision support (C.D.S.) to improve the use of the ventilator, the status includes one or more of a warning, an automatic color coding of an esophageal waveform to indicate
that an accuracy of the esophageal pressure data is either reliable or unreliable, and
one or more parameters derived from the esophageal waveform.

### Claim 5 (depends on 4)

The system of claim 4, wherein the status on the display is used to improve one or more of a placement and setup of the two or more sensors to provide the esophageal pressure data.

### Claim 6 (depends on 4)

The system of claim 4, wherein the processor automatically determines whether an occlusion test is successful from an analysis of a change in esophageal pressure divided by the change in airway pressure during times of zero flow.

### Claim 7 (depends on 6)

The system of claim 6, wherein the system uses one or more of the esophageal pressure data, the airway pressure data and the airway flow data to indicate a direction to relocate the two or more sensors in an esophagus of the patient.

### Claim 8 (depends on 1)

The system of claim 1, wherein the processor uses the esophageal pressure data to determine an intrinsic PEEP in the patient.

### Claim 9 (depends on 8)

The system of claim 8, wherein the intrinsic PEEP is automatically detected by measuring a change in esophageal pressure data during a patient triggering before a change to one or more of the airway pressure data and the airway flow data at a start of a breath of the patient.

### Claim 10 (depends on 8)

The system of claim 8, wherein the processor uses settings from a ventilator control algorithm as input along with a degree of the intrinsic PEEP to automatically calculate changes to settings in the ventilator.

### Claim 11 (depends on 10)

The system of claim 10, wherein the settings in the ventilator include one or more of a PEEP setting, a sensitivity level, a cycling criteria, a pressure support level, a tidal volume, a breath rate, and an inspiration-expiration (I:E) ratio.

### Claim 12 (depends on 1)

The system of claim 1, wherein the processor uses a transpulmonary pressure data to calculate a change in a PEEP.

### Claim 13 (depends on 12)

The system of claim 12, wherein the PEEP is managed by maintaining the transpulmonary pressure data at end of exhalation of the patient in a predetermined range.

### Claim 14 (depends on 13)

The system of claim 13, wherein the processor uses one or more of a patient diagnosis, patient lung characteristics, and ventilator settings to calculate a change in the PEEP.

### Claim 15 (depends on 14)

The system of claim 14, wherein the transpulmonary pressure data is used by the processor to calculate a change in a tidal volume of the patient to maintain peak transpulmonary pressure below a predetermined level.

### Claim 16 (depends on 1)

The system of claim 1, wherein the processor automatically make changes to a ventilator control algorithm when the accuracy of the esophageal pressure data is above a threshold of accuracy.

### Claim 17 (depends on 16)

The system of claim 16, wherein the processor automatically make changes to a ventilator control algorithm including using the esophageal pressure data to control breath delivery.

### Claim 18 (depends on 1)

The system of claim 1, further comprising;
based on the change in the esophageal pressure data during spontaneous breathing, automatically displaying on the display, positional information for repositioning one of the two or more sensors for measuring the esophageal pressure data relative to a stomach of the patient.

### Claim 19

A method to improve operation of a ventilator comprising:
accessing measurement data, by a computer processor, from two or more sensors for each of esophageal pressure data, airway pressure data, and airway flow data from a patient being ventilated;
continuously comparing, by the computer processor, the esophageal pressure data with changes to each of the airway pressure data and the air flow data to determine an accuracy of the esophageal pressure data; and
displaying, on a display, an automatic accuracy indicator to indicate a reliability of the esophageal pressure data.

### Claim 20

A computer program product for improving operation of a ventilator comprising a computer readable storage medium having a computer readable program stored therein, wherein the computer readable program, when executed on a computing device, causes the computing device to perform:
accessing measurement data from two or more sensors for each of esophageal pressure data, airway pressure data, and airway flow data from a patient being ventilated;
continuously comparing the esophageal pressure data with changes to each of the airway pressure data and the air flow data to determine an accuracy of the esophageal pressure data; and
displaying, on a display, an automatic accuracy indicator to indicate a reliability of the esophageal pressure data.
