# US 10,946,152 B2 · PC-based physiologic monitor and system for resolving apnea episodes during sedation

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- Number: US 10,946,152 B2
- Document ID: US10946152B2
- Status: Granted
- Kind: B2
- Application number: 15/823,108
- Filed: 2017-11-27
- Published: 2018-03-22
- Granted: 2021-03-16
- Earliest claimed: 2005-03-28
- Assignees: Koninklijke Philips N.V.
- Applicants: Koninklijke Philips N.V.
- Inventors: Eric W. Starr
- Web page: https://patentgrep.com/patent/US10946152B2

## CPC

- A61M 16/01: specially adapted for anaesthetising {(A61M16/104, A61M16/18 take precedence)}
- A61M 16/021: {operated by electrical means (A61M16/202 – A61M16/205 take precedence)}
- A61M 16/104: {specially adapted for anaesthetics (A61M16/18 takes precedence)}
- A61B 5/087: Measuring breath flow
- A61B 5/4818: {Sleep apnoea}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61M 2230/04: Heartbeat characteristics, e.g. ECG, blood pressure modulation
- A61M 2230/40: Respiratory characteristics
- A61M 2230/63: Motion, e.g. physical activity
- 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

An anesthesia delivery and monitoring system for use during outpatient surgery performed under sedation level anesthesia that includes a ventilatory system, a system for supplying sedation anesthesia, a respiratory sensor adapted to detect a respiration parameter of such a patient, and a system for supplying a timed back-up breath to such a patient through the ventilatory system. The timed back-up breaths are supplied in response to the respiration parameter falling outside a preset threshold and at a positive pressure exceeding a base operating pressure of the respiratory system. The system for supplying sedation anesthesia is an intravenous supply system for anesthesia, a ventilatory system coupled to the patient, a needle and syringe, or any combination thereof. The respiratory system includes a PC-based physiologic monitor with user modified feedback control signal.

## Claims

### Claim 1

A system for resolving apnea or hypopnea during sedation, the system comprising:
a respiratory sensor;
a pressure/flow generator; and
a computer programmed to perform a method for resolving apnea or hypopnea during sedation, the method including:
maintaining the pressure/flow generator at a normal operating pressure wherein the normal operating pressure is zero or is not enough to assist the patient in breathing;
while maintaining the normal operating pressure, using the respiratory sensor, detecting a time interval over which a patient is experiencing apnea or hypopnea; and
in response to and after detecting the time interval over which the patient is experiencing apnea or hypopnea, operating the pressure/flow generator to provide at least one back-up breath to the patient to assist the patient's breathing at a positive pressure exceeding the normal operating pressure and then returning to the maintaining of the pressure/flow generator at the normal operating pressure.

### Claim 2 (depends on 1)

The system of claim 1 comprising a passive back-up ventilator system in which the maintaining of the pressure/flow generator at the normal operating pressure comprises keeping the pressure/flow generator off except when operating the pressure/flow generator to provide the at least one back-up breath to the patient.

### Claim 3 (depends on 1)

The system of claim 1 further comprising:
an anesthesia gas supply input conduit; and
a CO2/anesthesia scrubber;
wherein the pressure/flow generator, the anesthesia gas supply input conduit, and the CO2/anesthesia scrubber are configured to operate as a system for supplying sedation anesthesia to the patient.

### Claim 4 (depends on 1)

The system of claim 1 further comprising an intravenous anesthesia supply system.

### Claim 5 (depends on 1)

The system of claim 1 wherein the pressure/flow generator comprises a blower.

### Claim 6 (depends on 1)

The system of claim 1 further comprising a nasal mask, nasal/oral mask, or nasal cannula operatively coupled to deliver the at least one back-up breath from the pressure/flow generator to the patient.

### Claim 7 (depends on 1)

The system of claim 1 wherein the respiratory sensor comprises a pressure sensor or flow sensor.

### Claim 8 (depends on 1)

The system of claim 1 wherein the respiratory sensor is configured to measure tidal volume of the patient's respiration over time and the time interval over which the patient is experiencing apnea or hypopnea is detected as a time interval without a breath as indicated by the measured tidal volume.

### Claim 9 (depends on 1)

The system of claim 1 wherein, in response to and after detecting the time interval over which the patient is experiencing apnea or hypopnea, the pressure/flow generator is operated to provide a single back-up breath to the patient at the positive pressure exceeding the normal operating pressure and then returns to the maintaining of the pressure/flow generator at the normal operating pressure.

### Claim 10 (depends on 1)

The system of claim 1 wherein the computer is a personal computer with its own operating system.

### Claim 11

A method for resolving apnea or hypopnea during sedation, the method comprising:
sedating a patient at a sedation level in which the airway is not protected and breathing is not assisted;
with the patient sedated, maintaining a normal operating pressure delivered to the patient by a pressure/flow generator wherein the normal operating pressure is zero or is not enough to assist the patient in breathing; and
with the patient sedated and while maintaining the normal operating pressure delivered to the patient, detecting a time interval over which the patient is experiencing apnea or hypopnea using a respiratory sensor and, in response to and after detecting the time interval over which the patient is experiencing apnea or hypopnea, operating the pressure/flow generator to provide at least one back-up breath to the patient to assist the patient's breathing at a positive pressure exceeding the normal operating pressure and then returning to the normal operating pressure delivered to the patient by the pressure/flow generator;
wherein the maintaining of the normal operating pressure, the detecting of the time interval over which the patient is experiencing apnea or hypopnea, and the operating of the pressure/flow generator to provide the at least one back-up breath to the patient are performed by a computer.

### Claim 12 (depends on 11)

The method of claim 11 wherein the maintaining of the normal operating pressure comprises keeping the pressure/flow generator off except when operating the pressure/flow generator to provide the at least one back-up breath to the patient.

### Claim 13 (depends on 11)

The method of claim 11 wherein sedating the patient includes delivering anesthesia to the patient using the pressure/flow generator maintained at the normal operating pressure delivered to the patient.

### Claim 14 (depends on 11)

The method of claim 11 wherein sedating the patient includes delivering anesthesia to the patient using an intravenous anesthesia supply system or a needle and syringe injection.

### Claim 15 (depends on 11)

The method of claim 11 wherein:
the normal operating pressure is delivered to the patient by the pressure/flow generator via a nasal mask, nasal/oral mask, or nasal cannula;
and the at least one back-up breath is provided to the patient via the nasal mask, nasal/oral mask, or nasal cannula.

### Claim 16 (depends on 11)

The method of claim 11 wherein the time interval over which the patient is experiencing apnea or hypopnea is detected as a time interval without a breath being detected using the respiratory sensor.

### Claim 17 (depends on 11)

The method of claim 11 wherein, in response to and after detecting the time interval over which the patient is experiencing apnea or hypopnea, the pressure/flow generator is operated to provide a single back-up breath to the patient at the positive pressure and then returns to the normal operating pressure delivered to the patient by the pressure/flow generator.

### Claim 18

A system for resolving apnea or hypopnea during sedation, the system comprising:
a respiratory sensor;
a blower; and
a computer programmed to perform a method for resolving apnea or hypopnea during sedation, the method including:
using the respiratory sensor, detecting a time interval over which a patient is experiencing apnea or hypopnea;
in response to and after detecting the time interval over which the patient is experiencing apnea or hypopnea, operating the blower to provide at least one back-up breath to the patient to assist the patient's breathing; and
keeping the blower off except when operated to provide the at least one back-up breath to the patient.

### Claim 19 (depends on 18)

The system of claim 18 wherein the time interval over which the patient is experiencing apnea or hypopnea is detected as a time interval without a breath as indicated by the measured tidal volume.

### Claim 20 (depends on 19)

The system of claim 19 wherein, in response to and after detecting the time interval over which the patient is experiencing apnea or hypopnea, the blower is operated to provide a single back-up breath to the patient.

### Claim 21

A system for resolving apnea or hypopnea during sedation, the system comprising:
a respiratory sensor;
a pressure/flow generator; and
a computer programmed to perform a method for resolving apnea or hypopnea during sedation, the method including:
maintaining the pressure/flow generator at a normal operating pressure wherein the normal operating pressure is zero or is not enough to assist the patient in breathing;
using the respiratory sensor, detecting a time interval over which a patient is experiencing apnea or hypopnea; and
in response to and after detecting the time interval over which the patient is experiencing apnea or hypopnea, operating the pressure/flow generator to provide at least one back-up breath to the patient to assist the patient's breathing at a positive pressure exceeding the normal operating pressure and then returning to the maintaining of the pressure/flow generator at the normal operating pressure; and
a passive back-up ventilator system in which the maintaining of the pressure/flow generator at the normal operating pressure comprises keeping the pressure/flow generator off except when operating the pressure/flow generator to provide the at least one back-up breath to the patient.
