# US 10,500,356 B2 · System and method for controlling insufflation pressure during inexsufflation

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- Number: US 10,500,356 B2
- Document ID: US10500356B2
- Status: Granted
- Kind: B2
- Application number: 14/386,462
- Filed: 2013-03-19
- Published: 2015-03-05
- Granted: 2019-12-10
- Earliest claimed: 2012-03-21
- Assignees: Koninklijke Philips N.V.
- Applicants: Koninklijke Philips N.V.
- Inventors: Peter Douglas Hill; Seunghyun Lee; April Stewart Nathan
- Web page: https://patentgrep.com/patent/US10500356B2

## CPC

- A61M 16/0003: {Accessories therefor, e.g. sensors, vibrators, negative pressure}
- A61M 16/00: Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators (iron lungs A61H31/02); Tracheal tubes
- A61M 16/0009: {with sub-atmospheric pressure, e.g. during expiration}
- A61M 16/024: {including calculation means, e.g. using a processor}
- A61M 16/161: {with means for measuring the humidity}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0033: {electrical}
- A61M 2016/0036: {in the breathing tube and used in both inspiratory and expiratory phase}
- A61M 2205/3303: Using a biosensor
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3365: Rotational speed
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- 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

The present disclosure pertains to a system and method for controlling insufflation pressure during inexsufflation of a subject. The system inexsufflates the subject such that tidal flow and/or tidal volume are monitored during insufflation, and insufflation pressure is adjusted to maintain the flow rate of the pressurized flow of breathable gas until a target tidal volume is reached for the insufflation. When the target tidal volume has substantially been reached, the system is causes gas to be evacuated from the airway of the subject. This may provide for more precise, customized therapy for the subject than is provided by conventional inexsufflation systems in which inspiratory flow may not be monitored and/or controlled. In one embodiment, the system comprises one or more of a pressure generator, a subject interface, one or more sensors, a processor, a user interface, electronic storage, and/or other components.

## Claims

### Claim 1

A system configured to inexsufflate a subject, the system comprising:
a pressure generator configured to generate and control delivery of a pressurized flow of breathable gas to an airway of the subject;
one or more sensors configured to generate output signals conveying information related to one or more gas parameters of the pressurized flow of breathable gas; and
one or more processors configured by machine-readable instructions to:
determine a target tidal flow rate, a target tidal volume, and an insufflation pressure limit based on the output signals and information related to previous respiration by the subject;
cause the pressure generator to steadily increase a pressure of the pressurized flow of breathable gas such that a flow rate of the pressurized flow of breathable gas is maintained at the target tidal flow rate;
responsive to the pressure of the pressurized flow of breathable gas reaching the insufflation pressure limit, cause the pressure generator to maintain the pressure of the pressurized flow of breathable gas at the insufflation pressure limit without maintaining the flow rate at the target tidal flow rate, wherein the insufflation pressure limit is reached as a result of steadily increasing the pressure starting at a beginning of inhalation of the subject; and
responsive to a determination that the target tidal volume is reached or a determination that the target tidal volume is not reached within a predetermined amount of time, cause the pressure generator to decrease the pressure of the pressurized flow of breathable gas to a negative exsufflation pressure to evacuate the gas from the airway of the subject.

### Claim 2 (depends on 1)

The system of claim 1, wherein the one or more processors are further configured to (i) determine a dwell time and a dwell pressure, (ii) responsive to the determination that the target tidal volume is reached or the determination that the target tidal volume is not reached within the predetermined amount of time, cause the pressure generator to adjust the pressure of the pressurized flow of breathable gas to the dwell pressure such that the tidal flow rate is at or near zero during the dwell time, and (iii) responsive to the expiration of the dwell time, cause the pressure generator to evacuate the gas from the airway of the subject.

### Claim 3 (depends on 2)

The system of claim 2, further comprising a user interface, wherein the one or more processors are further configured to facilitate, via the user interface, entry of information indicating one or more of a starting insufflation pressure, the target tidal flow, or the target tidal volume by the subject.

### Claim 4 (depends on 1)

The system of claim 1, wherein the subject triggers the system to begin insufflation.

### Claim 5 (depends on 1)

The system of claim 1, wherein the one or more processors are configured such that the predetermined amount of time is (i) determined based on the output signals and the information related to previous respiration by the subject, and (ii) adjustable during an insufflation based on one or more of a lung compliance of the subject, a maximum insufflation pressure during the insufflation, or the flow rate of the pressurized flow of breathable gas during the insufflation.

### Claim 6

A method of controlling a process of inexsufflating a subject with a system, the system comprising a pressure generator, one or more sensors, and one or more processors, the method comprising:
generating and controlling, with the pressure generator, delivery of a pressurized flow of breathable gas to an airway of the subject;
determining, with the one or more processors, a target tidal flow rate, a target tidal volume, and an insufflation pressure limit based on the output signals and information related to previous respiration by the subject;
causing, with the one or more processors, the pressure generator to steadily increase a pressure of the pressurized flow of breathable gas such that a flow rate of the pressurized flow of breathable gas is maintained at the target tidal flow rate;
responsive to the pressure of the pressurized flow of breathable gas reaching the insufflation pressure limit, causing, with the one or more processors, the pressure generator to maintain the pressure of the pressurized flow of breathable gas at the insufflation pressure limit without maintaining the flow rate at the target tidal flow rate, wherein the insufflation pressure limit is reached as a result of steadily the pressure starting at a beginning of inhalation of the subject; and
responsive to a determination that the target tidal volume is reached or a determination that the target tidal volume is not reached within a predetermined amount of time, causing, with the one or more processors, the pressure generator to decrease the pressure of the pressurized flow of breathable gas to a negative an exsufflation to evacuate the gas from the airway of the subject.

### Claim 7 (depends on 6)

The method of claim 6, further comprising:
(i) determining, with the one or more processors, a dwell time and a dwell pressure, (ii) responsive to the determination that the target tidal volume is reached or the determination that the target tidal volume is not reached within the predetermined amount of time, causing, with the one or more processors, the pressure generator to adjust the pressure of the pressurized flow of breathable gas to the dwell pressure such that the tidal flow rate is at or near zero during the dwell time, and (iii) responsive to the expiration of the dwell time, causing, with the one or more processors, the pressure generator to evacuate the gas from the airway of the subject.

### Claim 8 (depends on 7)

The method of claim 7, further comprising facilitating, via a user interface, entry of information indicating one or more of a starting insufflation pressure, the target tidal flow, or the target tidal volume via a user interface by the subject.

### Claim 9 (depends on 6)

The method of claim 6, wherein the subject triggers the start of insufflation.

### Claim 10 (depends on 6)

The method of claim 6, wherein the predetermined amount of time is (i) determined based on the output signals and the information related to previous respiration by the subject, and (ii) adjustable during an insufflation based on one or more of a lung compliance of the subject, a maximum insufflation pressure during the insufflation, or the flow rate of the pressurized flow of breathable gas during the insufflation.

### Claim 11

A system configured to inexsufflate a subject, the system comprising:
means for generating and controlling delivery of a pressurized flow of breathable gas to the airway of the subject;
means for generating output signals conveying information related to one or more gas parameters of the pressurized flow of breathable gas;
means for determining a target tidal flow rate, a target tidal volume, and an insufflation pressure limit based on the output signals and information related to previous respiration by the subject;
means for causing the pressure generator to steadily increase a pressure of the pressurized flow of breathable gas such that a flow rate of the pressurized flow of breathable gas is maintained at the target tidal flow rate;
responsive to the pressure of the pressurized flow of breathable gas reaching the insufflation pressure limit, means for causing the pressure generator to maintain the pressure of the pressurized flow of breathable gas at the insufflation pressure limit without maintaining the flow rate at the target tidal flow rate, wherein the insufflation pressure limit is reached as a result of steadily increasing the pressure starting at a beginning of inhalation of the subject; and
responsive to a determination that the target tidal volume is reached or a determination that the target tidal volume is not reached within a predetermined amount of time, means for causing the pressure generator to decrease the pressure of the pressurized flow of breathable gas to a negative an exsufflation to evacuate the gas from the airway of the subject.

### Claim 12 (depends on 11)

The system of claim 11, further comprising:
(i) means for determining a dwell time and a dwell pressure, (ii) responsive to the determination that the target tidal volume is reached or the determination that the target tidal volume is not reached within the predetermined amount of time, means for causing the pressure generator to adjust the pressure of the pressurized flow of breathable gas to the dwell pressure such that the tidal flow rate is at or near zero during the dwell time, and (iii) responsive to the expiration of the dwell time, means for causing the pressure generator to evacuate the gas from the airway of the subject.

### Claim 13 (depends on 12)

The system of claim 12, further comprising means for facilitating entry of information indicating one or more of a starting insufflation pressure, the target tidal flow, or the target tidal volume by the subject.

### Claim 14 (depends on 11)

The system of claim 11, wherein the subject triggers the system to begin insufflation.

### Claim 15 (depends on 11)

The system of claim 11, wherein the predetermined amount of time is (i) determined based on the output signals and the information related to previous respiration by the subject, and (ii) adjustable during an insufflation based on one or more of a lung compliance of the subject, a maximum insufflation pressure during the insufflation, or the flow rate of the pressurized flow of breathable gas during the insufflation.
