MRI/NMR-COMPATIBLE, TIDAL VOLUME CONTROL AND MEASUREMENT SYSTEMS, METHODS, AND DEVICES FOR RESPIRATORY AND HYPERPOLARIZED GAS DELIVERY

• US 20080000471A1
• Filed: 09/06/2007
• Published: 01/03/2008
• Est. Priority Date: 04/22/2003
• Status: Active Grant

• Current Assignee: Polarean, Inc. (Polarean Imaging Plc)
• Original Assignee: James Borgen, Kenneth Bolam
• Inventors: Bolam, Kenneth, Borgen, James
• Granted Patent: US 7,610,914 B2
• Time in Patent Office: Days
• US Class Current: 128/200.24
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]
• CPC Class Codes: A61M 2202/0291 Xenon

Abstract

Ventilator systems include: (a) a mass flow controller; (b) a gas delivery valve in communication with the mass flow controller and configured to selectively dispense a plurality of different gases to a subject; (c) a first gas source in fluid communication with the gas delivery valve; (d) a second gas source in fluid communication with the gas delivery valve; (e) a first pressure sensor located upstream of the gas delivery valve; (f) a second pressure sensor located downstream of the gas delivery valve; and (g) a controller operatively associated with the first and second pressure sensors and the mass flow controller, the controller comprising computer program code that monitors the pressures measured by the first and second pressure sensors and automatically dynamically adjusts the flow rate of the mass flow controller.

Claims

1. A ventilator system having a ventilation flow path for ventilating a subject, comprising:

a mass flow controller;

a gas delivery valve disposed downstream of and in communication with the mass flow controller, the gas delivery valve being configured to selectively dispense a plurality of different gases to a subject;

a first gas source in fluid communication with the gas delivery valve;

a second gas source in fluid communication with the gas delivery valve;

a first pressure sensor located upstream of the gas delivery valve;

a second pressure sensor located downstream of the gas delivery valve; and

a controller operatively associated with the first and second pressure sensors and the mass flow controller, the controller configured to monitor the pressures measured by the first and second pressure sensors and the flow rate of the mass flow controller and automatically determine a delivered tidal volume using a reading of the flow rate of the mass flow controller when the first pressure is at a substantially steady state condition.

2. A ventilator system according to claim 1, wherein the controller is configured to automatedly adjust the flow rate of the mass flow controller so that the pressure measured by the first pressure sensor is substantially constant during delivery of hyperpolarized gas.

3. A ventilator system according to claim 2, wherein the first gas source is a polarized gas source and the second gas source is a non-polarized gas source, said system further comprising a tracheal tube in fluid communication with the gas delivery valve, wherein the gas delivery valve is configured with a vent port that allows expired breath to vent during expiration, and wherein the gas delivery valve is configured to operate at a selectable breath per minute rate and inhale/exhale ratio with a breath-hold duration and to selectively deliver the polarized gas alone or with the non-polarized gas.

4. A ventilator system according to claim 1, wherein the system is configured to be run in a user selectable set tidal volume mode or a set peak inspiration pressure mode.

5. A ventilator system according to claim 1, wherein the mass flow controller has a variable mass flow rate, and wherein the controller is configured to dynamically monitor the first pressure and adjust the flow rate of the mass flow controller responsive thereto to deliver a user-selected predetermined fixed tidal volume.

6. A ventilator system according to claim 3, wherein the controller is configured to calculate an adjusted delivered tidal volume in situ based on the difference between a the total tidal volume and a fixed geometric volume of the ventilator flow path that includes a portion of the ventilator flow path and the tracheal tube.

7. A ventilator system according to claim 1, wherein the controller is configured to determine the delivered tidal volume using the mathematical relationship:

flow rate/frequency=volume exhausted per cycle  

 

(1),

where the flow rate is the flow rate of the mass flow controller taken when the first pressure is substantially stable or constant and frequency is the breath per minute rate.

8. A ventilator according to claim 7, further comprising a temperature monitor in communication with the controller.

9. A ventilator according to claim 8, wherein the temperature monitor is in communication with a thermal source that is configured to heat and/or cool a subject to a desired temperature during operation.

10. A ventilator system according to claim 3, further comprising a tracheal tube end cap for closing off the tracheal tube, wherein said gas delivery valve comprises a plurality of gas actuation valves in communication with a plurality of gas flow paths for selecting at least one gas flow path therein, said system further comprising computer program code for calculating a fixed volume “

V1”

.

11. A ventilator system according to claim 3, wherein the ventilator system is configured for small animals.

12. A ventilator system according to claim 11, wherein the controller is configured to generate an estimated incremental decrease or increase of flow rate to provide a substantially constant pressure at the first sensor based on a selected breath per minute rate and an estimated volume of the animal'"'"'s lungs.

13. A ventilator system according to claim 11, wherein the controller is operably associated with computer program code of a library of a priori values of predicted animal volumetric characteristics and/or animal volumetric changes at a plurality of different peak inspiration pressures.

14. A ventilator system according to claim 11, wherein the ventilator system is configured to deliver a millimole amount of polarized ¹²⁹Xe gas and/or polarized ³He.

15. A ventilator system according to claim 11, wherein the ventilator is configured to operate with selectable breath per minute rates in the range of about 5-180.

16. A ventilator system according to claim 1, wherein the polarized gas source comprises a pressure vessel holding a bag of polarized gas therein, wherein the bag of polarized gas is compressible by the controlled pressure of a non-polarized gas directed into the vessel, and wherein the system further comprises computer program code that calculates and applies a calibration factor to define the pressure used to compress the bag to expel a desired amount of polarized gas.

17. A ventilator system according to claim 16, wherein the ventilator is configured to operate with selectable inspiration/expiration ratios from between about 5:

1 to 1;

5.

18. A ventilator system according to claim 11, wherein the ventilator system is configured to operate with a controllable peak inspiration pressure of between about 0-40 inches of H₂0.

19. A ventilator system according to claim 18, wherein the ventilator is configured to provide a tidal volume flow of between about 0-5 liters/min.

20. A ventilator system according to claim 11, wherein the ventilator system is configured to operate with MRI/NMR systems having up to about 5 T magnetic fields.

21. A ventilator system according to claim 11, wherein the ventilator system is configured to operate with MRI/NMR systems having less than about 100 Gauss magnetic fields.

22. A ventilator system according to claim 1, further comprising a physiological monitor for monitoring heart rate and an ECG (electrocardiogram) device.

23. A ventilator system according to claim 3, wherein the gas delivery valve is configured to provide gas flow paths for ventilation breath inhale inputs and/or receive exhale outputs of at least:

(a) hyperpolarized Gas A inhale;

(b) exhale;

(c) hyperpolarized Gas A inhale and hold; and

(d) non-polarized gas input.

24. A ventilator system according to claim 23, wherein the gas delivery valve is configured to provide ventilation breath inhale inputs and/or receive exhale outputs of at least:

(a) hyperpolarized Gas A inhale;

(b) non-polarized Gas B inhale;

(c) a combination of hyperpolarized Gas A and non-polarized Gas B inhale;

(d) exhale;

(e) partial exhale and hold;

(f) hyperpolarized Gas A inhale and hold;

(g) Gas B inhale and hold; and

(h) a combination of hyperpolarized Gas A and Gas B inhale and hold.

25. A ventilator system according to claim 24, wherein the gas delivery valve is fabricated from and/or coated with a material that inhibits depolarization of the hyperpolarized gas and is non-magnetic.

26. A ventilator system according to claim 1, wherein the system has an associated fluid capacitance disposed intermediate the mass flow controller and the gas delivery valve.

27-59. -59. (canceled)

50. A system for delivering hyperpolarized gas to a subject, comprising:

a gas delivery valve configured to deliver hyperpolarized gas and at least one non-polarized gas to a subject;

a mass flow controller disposed upstream of the gas delivery valve;

a tracheal tube disposed downstream of the gas delivery valve;

means for monitoring a first pressure in the ventilator system upstream of the gas delivery valve;

means for monitoring a second pressure in the ventilator system downstream of the gas delivery valve;

means for automatically obtaining readings of the mass flow controller; and

means for automatically determining the tidal inspiration volume of hyperpolarized gas delivered to the subject in situ using the monitored first pressure and the value of a reading of the mass flow controller obtained when the first pressure is substantially constant.

51. A system according to claim 50, wherein the ventilator system includes a variable flow rate mass flow controller disposed upstream of the gas delivery valve, said system further comprising means for automatically dynamically adjusting the flow rate of the mass flow controller to maintain a substantially constant pressure at the first pressure sensor during delivery of the hyperpolarized gas to the subject.

52. A system according to claim 50, further comprising:

means for accepting user input to select a tidal volume operational mode with the desired tidal volume selected or a peak inspiration pressure operational mode with the desired peak inspiration pressure selected; and

a second mass flow controller, wherein the first and second mass flow controllers are used to automatically provide desired blends of selected ventilation gases to the subject.

53. A computer program product for delivering hyperpolarized gas using a ventilator with an associated gas delivery valve and tracheal tube, the computer program product comprising:

computer program code that monitors a first pressure in the ventilator system upstream of the gas delivery valve;

computer program code that monitors a second pressure in the ventilator system downstream of the gas delivery valve;

computer program code that obtains a reading of a mass flow controller when the first pressure stabilizes at a substantially constant pressure; and

computer program code that calculates a tidal volume using the reading of the mass flow controller when the first pressure is substantially constant.

54. A computer program product according to claim 53, wherein the ventilator system includes a variable flow rate mass flow controller disposed upstream of the gas delivery valve, and wherein said computer program product further comprises computer program code that automatically dynamically adjusts the flow rate of the mass flow controller to maintain a substantially constant first pressure during ventilation delivery of the hyperpolarized gas to the subject.

55. A computer program product according to claim 54, further comprising computer program code for accepting user input to select from predetermined operational modes:

(a) a tidal volume operational mode with the desired tidal volume selected; and

(b) a peak inspiration pressure operational mode with the desired peak inspiration pressure selected.

56. A computer program product according to claim 53, further comprising computer program code that selectively configures the gas delivery valve for inhale, exhale, or breath-hold operation.

57. A computer program product according to claim 56, further comprising computer program code that selectively operates the gas delivery valve to output hyperpolarized gas alone, non-polarized gas alone, and/or a blend of hyperpolarized and non-polarized gas.

58. A computer program product according to claim 53, further comprising computer program code that controllably actuates the gas delivery valve to select ventilation operation between at least:

(a) hyperpolarized gas inhale;

(b) non-polarized gas inhale;

(c) a combination of hyperpolarized gas and non-polarized gas inhale;

(d) exhale;

(e) partial exhale and hold;

(f) hyperpolarized gas inhale and hold;

(g) non-polarized gas inhale and hold; and

(h) a combination of hyperpolarized gas and non-polarized gas inhale and hold.

59. A computer program product according to claim 57, wherein the hyperpolarized gas is a hyperpolarized noble gas, and wherein the non-polarized gas is a selected biocompatible non-polarized gas that inhibits depolarization of the hyperpolarized gas, and wherein the product further comprises computer program code that operates first and second mass flow controllers to automatically provide desired blends of selected ventilation gases to the subject.

60-60. -60. (canceled)