# US 10,946,159 B2 · System for providing flow-targeted ventilation synchronized to a patient's breathing cycle

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- Number: US 10,946,159 B2
- Document ID: US10946159B2
- Status: Granted
- Kind: B2
- Application number: 15/415,555
- Filed: 2017-01-25
- Published: 2017-05-11
- Granted: 2021-03-16
- Earliest claimed: 2007-01-26
- Assignees: CS Medical, Inc.
- Applicants: CS Medical, Inc.
- Inventors: Kent L. Christopher; Stephanie S. Diehl
- Web page: https://patentgrep.com/patent/US10946159B2

## CPC

- A61M 16/085: {Gas sampling}
- A61B 5/087: Measuring breath flow
- A61B 5/097: Devices for facilitating collection of breath or for directing breath into or through measuring devices
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61M 16/0051: {with alarm devices}
- A61M 16/0066: {Blowers or centrifugal pumps}
- A61M 16/024: {including calculation means, e.g. using a processor}
- A61M 16/0434: {Cuffs}
- A61M 16/0465: {Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters}
- A61M 16/0486: {Multi-lumen tracheal tubes}
- A61M 16/0488: {Mouthpieces; Means for guiding, securing or introducing the tubes (guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02)}
- A61M 16/0666: {Nasal cannulas or tubing (devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02)}
- A61M 16/0672: {Nasal cannula assemblies for oxygen therapy}
- A61M 16/0816: {Joints or connectors}
- A61M 16/0833: {T- or Y-type connectors, e.g. Y-piece}
- A61M 16/0875: {Connecting tubes}
- A61M 16/101: {using an oxygen concentrator}
- A61M 16/1095: {in the connecting tubes}
- A61M 16/12: by mixing different gases
- A61M 16/125: {Diluting primary gas with ambient air}
- A61M 16/16: Devices to humidify the respiration air {(A61M16/1045 takes precedence)}
- A61M 16/161: {with means for measuring the humidity}
- A61B 5/0836: {Measuring rate of CO2 production}
- A61B 5/6852: {Catheters}
- A61M 16/0461: {Nasoendotracheal tubes}
- A61M 16/0484: {at the distal end}
- A61M 16/10: Preparation of respiratory gases or vapours
- A61M 16/208: {Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves}
- A61M 2016/0021: {with a proportional output signal, e.g. from a thermistor}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0036: {in the breathing tube and used in both inspiratory and expiratory phase}
- A61M 2016/0039: {in the inspiratory circuit}
- A61M 2016/1025: {the O2 concentration}
- A61M 2202/0208: Oxygen
- A61M 2202/025: Helium
- A61M 2202/0275: Nitric oxide [NO]
- A61M 2205/16: with back-up system in case of failure
- A61M 2205/18: with alarm
- A61M 2205/32: with radio-opaque indicia
- A61M 2205/3368: Temperature
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/70: with testing or calibration facilities
- A61M 2230/202: partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
- A61M 2230/205: partial oxygen pressure (P-O2)
- A61M 2230/432: partial CO2 pressure (P-CO2)
- 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 system selectively delivers either breath-synchronized, flow-targeted ventilation (BSFTV) or closed-system positive pressure ventilation (CSPPV) to augment respiration of a patient with a standard tracheal tube. A removable adaptor has a cap that can be removably attached to the proximal connector of the tracheal tube in BSFTV mode, and an inner cannula that extends within the tracheal tube to effectively divide it into two lumens. The adaptor includes a ventilator connector for removably engaging a ventilator hose to deliver air/oxygen through the adaptor and one lumen of the tracheal tube with a flow rate varying over each respiratory cycle in a predetermined waveform synchronized with the patient's respiratory cycle to augment the patient's spontaneous respiration. The adaptor also includes a port allowing the spontaneously-breathing patient to freely inhale and exhale in open exchange with the atmosphere through the other lumen.

## Claims

### Claim 1

A method for selectively administering either closed-system positive-pressure ventilation (CSPPV) or breath-synchronized flow-targeted ventilation (BSFTV) to a patient having a tracheal tube with an inflatable cuff, said method comprising:
providing a ventilator selectively delivering either CSPPV or BSFTV to the patient via a ventilator hose;
in CSPPV mode, connecting the ventilator hose to the proximal end of the tracheal tube and operating the ventilator to provide closed-system positive-pressure ventilation to the patient through the tracheal tube;
in BSFTV mode:
(a) providing an adaptor having: (i) a cap with a first connector for removable attachment to the ventilator hose, and a second connector for removable attachment to the proximal end of the tracheal tube; and (ii) an inner cannula extending from the cap that is removably insertable into the tracheal tube to divide the tracheal tube into a first lumen and a second lumen, with the first lumen of the tracheal tube allowing a spontaneously-breathing patient to freely inhale and exhale in open exchange with the atmosphere through the tracheal tube and adaptor;
(b) attaching the adaptor to the tracheal tube by inserting the inner cannula into the tracheal tube and attaching the second connector of the adaptor cap to the proximal end of the tracheal tube; and
(c) providing a sensor for detecting a physical property of the patient's respiratory cycle;
in the BSFTV mode, attaching the ventilator hose to the first connector of the adaptor cap, and operating the ventilator to deliver a flow of oxygen-containing gas to the patient through the adaptor cap and the second lumen of the tracheal tube to augment a patient's spontaneous respiration, said delivered flow varying over each inspiratory and expiratory phase of the respiratory cycle in a predetermined non-constant flow waveform synchronized with the respiratory cycle as detected by the sensor to augment the patient's spontaneous respiration having:
(a) a positive flow accelerating at the onset of the patient's inspiratory phase at a flow rate sufficient to significantly mitigate the airway pressure the patient must generate during spontaneous breathing and thereby reduce the patient's work of breathing; and
(b) a positive flow during at least the early portion of the patient's expiratory phase at a flow rate sufficient to significantly mitigate the airway pressure the patient must generate during spontaneous breathing and thereby reduce the patient's work of breathing, and to wash carbon dioxide from the patient's airway;
said delivered flow allowing a spontaneously-breathing patient to freely inhale and exhale in open exchange with the atmosphere through the first lumen of the tracheal tube and adaptor; and
to transition from the BSFTV mode to the CSPPV mode, disconnecting the adaptor from the ventilator hose, and removing the adaptor from the tracheal tube.

### Claim 2 (depends on 1)

The method of claim 1 wherein the sensor is attached to the inner cannula.

### Claim 3 (depends on 1)

The method of claim 1 wherein the adaptor further comprises a gas sampling tube extending along the inner cannula leading to the sensor.

### Claim 4 (depends on 1)

The method of claim 1 wherein the sensor comprises a flow sensor monitoring the patient's spontaneous respiration through the first lumen of the tracheal tube.

### Claim 5 (depends on 1)

The method of claim 1 wherein the sensor comprises a thermistor the patient's spontaneous respiration through the first lumen of the tracheal tube.

### Claim 6 (depends on 1)

The method of claim 1 wherein the sensor comprises a pressure transducer monitoring the patient's spontaneous respiration through the first lumen of the tracheal tube.

### Claim 7 (depends on 1)

The method of claim 1 wherein the sensor comprises a carbon dioxide sensor monitoring the patient's spontaneous respiration through the first lumen of the tracheal tube.
