# US 11,998,689 B2 · Enhanced performance verification port for therapeutic gas delivery

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- Number: US 11,998,689 B2
- Document ID: US11998689B2
- Status: Granted
- Kind: B2
- Application number: 17/525,349
- Filed: 2021-11-12
- Published: 2022-03-10
- Granted: 2024-06-04
- Earliest claimed: 2014-05-09
- Assignees: Mallinckrodt Pharmaceuticals Ireland Limited
- Applicants: Mallinckrodt Pharmaceuticals Ireland Limited
- Inventors: Jaron M. Acker; John C. Falligant; Jeff Milsap; Robin Roehl; Jeffrey Schmidt; Craig R. Tolmie
- Web page: https://patentgrep.com/patent/US11998689B2

## CPC

- A61M 16/0051: {with alarm devices}
- A61M 16/024: {including calculation means, e.g. using a processor}
- A61M 16/1005: {with O2 features or with parameter measurement}
- A61M 16/12: by mixing different gases
- A61M 16/122: {with dilution}
- A61M 16/125: {Diluting primary gas with ambient air}
- A61M 16/201: {Controlled valves}
- A61M 16/202: {electrically actuated}
- A61M 16/204: {used for inhalation control}
- B63C 11/02: Divers' equipment
- G01F 22/02: involving measurement of pressure
- A61M 16/085: {Gas sampling}
- A61M 16/208: {Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0039: {in the inspiratory circuit}
- A61M 2016/102: {Measuring a parameter of the content of the delivered gas}
- A61M 2202/0275: Nitric oxide [NO]
- A61M 2205/14: Detection of the presence or absence of a tube, a connector or a container in an apparatus
- A61M 2205/15: Detection of leaks
- A61M 2205/16: with back-up system in case of failure
- A61M 2205/17: with redundant control systems
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2205/50: with microprocessors or computers
- 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 2205/60: with identification means
- A61M 2205/6018: providing set-up signals for the apparatus configuration
- A61M 2205/6054: Magnetic identification systems
- A61M 2205/6072: Bar codes
- A61M 2205/70: with testing or calibration facilities
- A61M 2205/8206: battery-operated
- F17C 2250/00: Accessories; Control means; Indicating, measuring or monitoring of parameters
- 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)}
- B63C: LAUNCHING, HAULING-OUT, OR DRY-DOCKING OF VESSELS; LIFE-SAVING IN WATER; EQUIPMENT FOR DWELLING OR WORKING UNDER WATER; MEANS FOR SALVAGING OR SEARCHING FOR UNDERWATER OBJECTS (floating nets, floating slipways, or the like for recovering aircraft from the water B63B35/52)
- G01F: MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
- F17C: VESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES (storing fluids in natural or artificial cavities or chambers in the earth B65G5/00; construction or assembling of bulk storage containers employing civil-engineering techniques E04H7/00; variable-capacity gas-holders F17B; liquefaction or refrigeration machines, plants, or systems F25)

## Abstract

Therapy gas delivery systems that provide run-time-to-empty information to a user of the system and methods for administering therapeutic gas to a patient. The therapeutic gas delivery system may include a gas pressure sensor attachable to a therapeutic gas source that communicates therapeutic gas pressure data to a therapeutic gas delivery system controller, a gas temperature sensor positioned to measure gas temperature in the therapeutic gas source that communicates therapeutic gas temperature data to the therapeutic gas delivery system controller, at least one flow controller that communicates therapeutic gas flow rate data to the therapeutic gas delivery system controller, at least one flow sensor that communicates flow rate data to the therapeutic gas delivery system controller, and at least one display that communicates run-time-to-empty to a user of the therapeutic gas delivery system. The therapeutic gas delivery system controller of the system includes a processor that executes an algorithm to calculate the run-time-to-empty from the data received from the gas pressure sensor, temperature sensor, flow controller and flow sensor, and directs the result to the display.

## Claims

### Claim 1

A therapeutic gas delivery system for confirming the proper functioning of gas delivery and injection module operation, comprising:
an inlet port;
a low pressure outlet port in fluid communication with the inlet port;
an injection module operable to be received at the low pressure outlet port;
a low pressure gas supply operable to provide a flow of breathing gas at the inlet port, wherein the flow of breathing gas is at a breathing gas flow rate;
a low pressure delivery flow sensor and a low pressure confirmatory flow sensor operable to measure the breathing gas flow rate from the low pressure gas supply, wherein the low pressure delivery flow sensor and the low pressure confirmatory flow sensor are in fluid communication with the inlet port and the low pressure outlet port;
an injector module having an injection module delivery flow sensor and an injection module confirmatory flow sensor operable to measure the breathing gas flow rate from the low pressure gas supply, wherein the injection module delivery flow sensor and the injection module confirmatory flow sensor are in fluid communication with the low pressure outlet port; and
a controller operable to determine if one of the measured breathing gas flow rates differs from any one of the other measured breathing gas flow rates by greater than a threshold amount, wherein the flow rate is measured at two or more of the low pressure confirmatory flow sensor, the low pressure delivery flow sensor, the injection module confirmatory flow sensor, and/or the injection module delivery flow sensor.

### Claim 2 (depends on 1)

The therapeutic gas delivery system of claim 1, wherein the controller is further operable to provide an alarm if the breathing gas flow rates measured at the low pressure confirmatory flow sensor, the low pressure delivery flow sensor, the injection module confirmatory flow sensor, or the injection module delivery flow sensor differs from any one of the other measured breathing gas flow rates measured at the low pressure confirmatory flow sensor, the low pressure delivery flow sensor, the injection module confirmatory flow sensor, or the injection module delivery flow sensor by greater than a threshold amount.

### Claim 3 (depends on 1)

The therapeutic gas delivery system of claim 1, wherein the low pressure delivery flow sensor and the low pressure confirmatory flow sensor are arranged in series, and wherein the injection module delivery flow sensor and the injection module confirmatory flow sensor are arranged in series.

### Claim 4 (depends on 3)

The therapeutic gas delivery system of claim 3, wherein the injection module delivery flow sensor and the injection module confirmatory flow sensor are bi-directional flow sensors that are configured to determine the direction of gas flow through the injection module.

### Claim 5 (depends on 1)

The therapeutic gas delivery system of claim 1, wherein the low pressure gas supply comprises a wall supply and/or a pressurized cylinder configured to provide air, oxygen, or a combination thereof.

### Claim 6 (depends on 1)

The therapeutic gas delivery system of claim 1, which further comprises a therapeutic gas source operable to provide a stream of therapeutic gas to the flow of breathing gas upstream from an output of the injection module, wherein the stream of therapeutic gas and breathing gas combine to provide an intended concentration of therapeutic gas.

### Claim 7 (depends on 6)

The therapeutic gas delivery system of claim 6, which further comprises a sampling line down stream from the output of the injection module to sample at least a portion of the flow of gas exiting the injection module to a gas analyzer for measurement of at least the concentration of therapeutic gas, wherein the controller is further operable to:
determine the concentration of therapeutic gas exiting the injection module; and
compare the measured concentration of therapeutic gas with the intended concentration of therapeutic gas.

### Claim 8 (depends on 7)

The therapeutic gas delivery system of claim 7, which further comprises adjusting a subsystem flow control valve to provide a stream of therapeutic gas at an intended therapeutic gas flow rate; and determining if the subsystem flow control valve is properly functioning, wherein the subsystem flow control valve is in fluid communication with the low pressure outlet port.

### Claim 9 (depends on 8)

The therapeutic gas delivery system of claim 8, further comprising a flow regulating valve operable to switch to divert the stream of therapeutic gas to an alternative flow path, wherein:
the injection module delivery flow sensor and the injection module confirmatory flow sensor measure the combined therapeutic gas flow rate and breathing gas flow rate;
the flow regulating valve is up stream from and in fluid communication with the low pressure outlet port, and the subsystem flow control valve is upstream from and in fluid communication with the flow regulating valve;
the injection module delivery flow sensor and the injection module confirmatory flow sensor measure the breathing gas flow rate; and
the controller determines if the flow regulating valve functioned properly by determining if the combined therapeutic gas flow rate and breathing gas flow rate decreased by the therapeutic gas flow rate when the flow regulating valve was switched to the alternative flow path.

### Claim 10 (depends on 9)

The therapeutic gas delivery system of claim 9, which further comprises two or more subsystem flow sensors operable to measure a flow rate, wherein the two or more subsystem flow sensors are upstream from and in fluid communication with the flow regulating valve; and
the controller compares the flow rates measured at each of the two or more subsystem flow sensors to determine if the two or more subsystem flow sensors are in agreement.

### Claim 11 (depends on 10)

The therapeutic gas delivery system of claim 10, wherein the controller further calculates therapeutic gas blending ratio from the measured flow rate measured by at least one of the two or more subsystem flow sensors and from the breathing gas flow rate measured by the low pressure delivery flow sensor; and
compares the calculated therapeutic gas blending ratio to the measured concentration of therapeutic gas exiting the injection module.

### Claim 12 (depends on 10)

The therapeutic gas delivery system of claim 10, further comprising a subsystem flow control valve operable to be adjusted to be completely open to provide the stream of therapeutic gas at a maximum therapeutic gas flow rate.

### Claim 13

A therapeutic gas delivery system comprising:
a gas source coupling operable to mate to a therapeutic gas source;
a gas delivery subsystem comprising one or more flow control channels having at least one shut off valve, at least one delivery flow sensor, and at least one confirmatory flow sensor;
a shut off operable to open to deliver a flow of therapeutic gas from a gas supply subsystem to the gas delivery subsystem to purge the gas supply subsystem and the at least one of the one or more flow control channels;
a connection valve and a shut off, wherein the gas supply subsystem is operable to be pressurized at least between the connection valve and the closed shut off to a pressure above atmospheric pressure;
a gas pressure sensor operable to monitor the pressure between the connection valve and the closed shut off valve for a predetermined time period; and
a controller operable to present an alarm if the pressure between the connection valve and the closed shut off valve decreases or increases more than an expected amount over the predetermined time period.

### Claim 14 (depends on 13)

The therapeutic gas delivery system of claim 13, further comprising a purge valve in fluid communication with the connection valve and between the closed shut off and the connection valve, operable to open to flush gas within the gas supply subsystem with gas from the mated therapeutic gas source.

### Claim 15 (depends on 13)

The therapeutic gas delivery system of claim 13, further comprising a gas source identifier reader operable to read a gas source identifier attached to the therapeutic gas source, wherein the gas source identifier contains information including at least of the identity, expiration date, and/or the concentration of the therapeutic gas supplied by the therapeutic gas source.

### Claim 16 (depends on 13)

The therapeutic gas delivery system of claim 13, wherein the one or more flow control channels includes at least a first flow control channel and a second flow control channel, wherein the shut off valve for the first flow control channel is selectively opened, while the shut off valve for the second flow control channel is closed; and the gas flow rate through the at least one delivery flow sensor and the at least one confirmatory flow sensor of the first flow control channel is measured.

### Claim 17 (depends on 16)

The therapeutic gas delivery system of claim 16, wherein the shut off valve for the second flow control channel is sequentially opened by selectively opening the shut off valve of the second flow control channel, and closing the shut off valve of the first flow control channel.

### Claim 18 (depends on 16)

The therapeutic gas delivery system of claim 16, further comprising a controller operable to:
compare the gas flow rate through the at least one delivery flow sensor with the gas flow rate through the at least one confirmatory flow sensor of the first flow control channel; and
present an alarm if there is a discrepancy between the gas flow rate through the at least one delivery flow sensor and the gas flow rate through the at least one confirmatory flow sensor.

### Claim 19

A therapeutic gas delivery system, comprising:
a therapeutic gas supply subsystem operable to detect a therapeutic gas source mated with the therapeutic gas supply subsystem; and
a gas delivery subsystem comprising one or more flow control channels comprising at least one shut off valve, at least one delivery flow sensor, and at least one confirmatory flow sensor, wherein:
the therapeutic gas supply subsystem and the one or more flow control channels within the gas delivery subsystem are initially purged with gas from the therapeutic gas source by delivering a flow of therapeutic gas from the gas supply subsystem to at least one of the one or more flow control channels;
a shutoff valve down stream from the therapeutic gas source is maintained in a closed state;
one or more flow sensors down stream from the shutoff valve are verified that no flow has been detected; and
an alert is provided if flow is detected by one or more flow sensors down stream from the shutoff valve.

### Claim 20 (depends on 19)

The therapeutic gas delivery system of claim 19, further comprising a gas source identifier reader operable to read information associated with the therapeutic gas source to determine the identity, concentration, and/or expiration date of the therapeutic gas source, wherein the correct identity, concentration, and/or expiration date is verified.

### Claim 21 (depends on 20)

The therapeutic gas delivery system of claim 20, wherein the shutoff valve down stream from the therapeutic gas source in a closed state until the correct identity, concentration, and/or expiration date is verified.