Gas delivery device and system for use in magnetic resonance imaging

• US 10,188,822 B2
• Filed: 03/13/2015
• Issued: 01/29/2019
• Est. Priority Date: 03/13/2014
• Status: Active Grant

• Current Assignee: Mallinckrodt Critical Care Finance Inc (Mallinckrodt plc), Mallinckrodt Pharma Ip Trading DAC (Mallinckrodt plc), Therakos, Inc (Mallinckrodt plc)
• Original Assignee: Mallinckrodt Hospital Products IP Ltd. (Mallinckrodt plc)
• Inventors: Flanagan, Craig, Newman, David, Acker, Jaron M., Tolmie, Craig R., Potenziano, Jim
• Primary Examiner(s): Ho, (Jackie) Tan-Uyen T
• Assistant Examiner(s): Boecker, Joseph D
• Application Number:
  US14/657,548
• Publication Number:
  US 20150258299A1
• Time in Patent Office: 1,418 Days
• Field of Search: 424718
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/026 specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• CPC Class Codes: A61M 16/0808 Condensation traps
• CPC Class Codes: A61M 16/085 Gas sampling
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/122 with dilution
• CPC Class Codes: A61M 16/16 Devices to humidify the respiration air A61M16/1045 takes precedence
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2016/1035 the anaesthetic agent concentration
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]
• CPC Class Codes: A61M 2205/05 combined with other kinds of therapy
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards

Abstract

The present invention relates to a device and method of delivering inhaled Nitric Oxide (iNO) to a patient situated in a Magnetic Resonance Imaging (MRI) suite.

Claims

1. A nitric oxide delivery system for providing inhaled nitric oxide (iNO) to a patient situated in an MRI suite, the nitric oxide delivery system comprising:

a patient connector;

a source of nitric oxide gas;

a length of an iNO delivery tube;

a source of breathing gas;

a monitoring control circuit;

a delivery control circuit;

a signal processor including a corrective signal processing algorithm comprising determining an inverse of the distortion transfer function produced by the length of iNO delivery tube;

determining a ventilator flow profile of individual breaths performed on a continuing basis during ventilation;

convolving the inverse of a distortion transfer function with a predicted breath flow profile; and

verifying a consistent ventilator flow profile; and

an injector module fluidly connected to the source of nitric oxide, the source of breathing gas and the delivery control circuit;

said injector module being located outside an iso-gauss safety line.

2. The nitric oxide delivery system of claim 1, wherein said patient connector is a wye.

3. The nitric oxide delivery system of claim 2, wherein said wye comprises an inspiratory limb and an expiratory limb.

4. The nitric oxide delivery system of claim 3, wherein a sampling tee and a gas injection tee are inserted into the inspiratory limb just proximal to the patient wye, and ventilator/waveform disynchrony is introduced by gas transport delays within the length of the iNO delivery tube connected to the gas injection tee.

5. The nitric oxide delivery system of claim 1, wherein the iNO delivery tube comprises tubing materials and or coatings which minimize oxygen ingress, thereby limiting NO₂ formation.

6. The nitric oxide delivery system of claim 4, wherein the length of iNO delivery tube connected to the gas injection tee minimizes both temporal flow distortion effects and NO₂ buildup effects in the iNO delivery tube.

7. The nitric oxide delivery system of claim 1, wherein the corrective signal processing algorithm removes distortion and delay caused by the length of iNO delivery tube.

8. The nitric oxide delivery system of claim 1, wherein the monitoring control circuit comprises a monitor CPU, a zero valve, sample pump, sampling port, sample flow sensor, and gas sampling bench.

9. The nitric oxide delivery system of claim 1, wherein the delivery control circuit comprises pressure transducer, a backup on/off switch, a pressure regulator, shutoff valve, a proportional control valve, and flow sensor.

10. The nitric oxide delivery system of claim 1, wherein the source of breathing gas is a mechanical ventilator.

11. The nitric oxide delivery system of claim 1, further including an alarm system operable by a signal from the signal processor indicative of a pre-determined concentration of NO.

12. The nitric oxide delivery system of claim 1 further comprising a display that provides an on-screen setup guide for use in the MRI suite.

13. The nitric oxide delivery system of claim 9, wherein the flow sensor is a thermal mass flowmeter, pneumotach, hot wire anemometer, thermal flow sensor, variable orifice, thermal time-of-flight, or rotating vane.

14. A nitric oxide delivery system for providing inhaled nitric oxide (iNO) to a patient situated in an MRI suite, the nitric oxide delivery system comprising:

a patient connector;

a source of nitric oxide gas;

a length of an iNO delivery tube;

a source of breathing gas;

a monitoring control circuit;

a delivery control circuit;

a signal processor including a corrective signal processing algorithm comprising determining an inverse of a distortion transfer function produced by the length of iNO delivery tube;

determining a ventilator flow profile of individual breaths performed on a continuing basis during ventilation;

convolving the inverse of the distortion transfer function with a predicted breath flow profile; and

verifying a consistent ventilator flow profile; and

an injector module fluidly connected to the source of nitric oxide, the source of breathing gas and the delivery control circuit;

said injector module being located inside an iso-gauss safety line.

15. The nitric oxide delivery system of claim 14, wherein the injector module is made of non-ferrous materials.

16. The nitric oxide delivery system of claim 14, wherein the injector module is located upstream from a humidifier.

17. The nitric oxide delivery system of claim 14, wherein the delivery system is made of non-ferrous materials.

18. The nitric oxide delivery system of claim 14, further comprising a display that provides an on-screen setup guide for use in the MRI suite.