Ventilator Apparatus and System of Ventilation

• US 20080295839A1
• Filed: 06/02/2008
• Published: 12/04/2008
• Est. Priority Date: 06/01/2007
• Status: Abandoned Application

• Current Assignee: Nader M. Habashi
• Original Assignee: Nader M. Habashi
• Inventors: Habashi, Nader M.
• Application Number:
  US12/131,922
• Publication Number:
  US 20080295839A1
• Time in Patent Office: Days
• US Class Current: 128/204.22
• CPC Class Codes: A61M 16/0003 Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: 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
• CPC Class Codes: A61M 16/1005 with O2 features or with parameter measurement
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• 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 2016/003 with a flowmeter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2016/0042 in the expiratory circuit
• CPC Class Codes: A61M 2016/1025 the O2 concentration
• CPC Class Codes: A61M 2016/103 the CO2 concentration
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3327 Measuring
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/202 : partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/42 : Rate
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/435 : partial O2 pressure (P-O2)
• CPC Class Codes: A61M 2230/60 : Muscle strain, i.e. measured on the user

Abstract

A ventilator (10) for use by a clinician in supporting a patient presenting pulmonary distress. A controller module (20) with a touch-screen display (26) operates a positive or negative pressure gas source (40) that communicates with the intubated or negative pressure configured patient through valved (46) supply and exhaust ports (42, 44). A variety of peripheral, central, and or supply/exhaust port positioned sensors (54) may be included to measure pressure, volumetric flow rate, gas concentration, transducer, and chest wall breathing work. Innovative modules and routines (30) are incorporated into the controller module enabling hybrid, self-adjusting ventilation protocols and models that are compatible with nearly every conceivable known, contemplated, and prospective technique, and which establish rigorous controls configured to rapidly adapt to even small patient responses with great precision so as to maximize ventilation and recruitment while minimizing risks of injury, atelectasis, and prolonged ventilator days.

Claims

1. A ventilator system for assisting the respiratory function of a patient under the direction of a clinician, comprising:

a supply pump and a control module in communication with a data circuit and a gas circuit having a plurality of valves and supply and exhaust ports, the control module including a display, input device, and a memory in communication with the data circuit;

a sensor array in communication with the data circuit that includes at least one oximeter, at least one capnometer, at least one pressure sensor, and at least one flow meter in communication with at least one of the exhaust and supply ports;

a command module resident in the memory operative to command the control module to adjustably actuate the pump and the plurality of valves to establish at least one pressure and at least one volume flow rate in the gas circuit;

at least one initialization parameter database resident in the memory to be communicable with the display and storing at least one model patient data array element that includes at least one of (a) a positive end expiratory pressure, (b) a SpO2 quantity, (c) an etCO2 quantity, (d) a FiO2 quantity, (e) a high pressure, (f) a low pressure, (g) a high time, (h) a low time;

(i) a pressure increment, (j) a time increment, (k) a tidal volume, (l) a machine respiratory frequency, (m) a pressure-volume slope, (n) a trigger pressure, and (o) occlusion pressure.

wherein the command module receives settings from the clinician via the input device and commands the control module to actuate the supply pump and commencing respiratory assistance to the patient whereby the gas circuit communicates with the patient using one each of the FiO2 quantity, the high and low pressure, and the high and low time;

wherein the command module communicates with the sensor array to measure a patient actual data array elements of at least one of (i) a patient SpO2 quantity, (ii) a patient etCO2 quantity, (iii) a peak expiratory flow rate, (iv) an end expiratory lung volume and (v) a spontaneous breathing frequency; and

wherein the command module compares the patient actual data array to the at least one model patient data array and adjusts to achieve a SpO2 goal value, an etCO2 goal value, and an optimal end expiratory lung volume.

2. The ventilator system according to claim 1, wherein if the SpO2 goal value is false, the command module communicates with the sensor array and ascertains the patient actual data array to ascertain the high pressure value;

and

wherein when the high pressure value is true the command module determines a FiO2 goal value that (a) when true, the control module adjusts at least one of the supply pump and the plurality of valves to increase the high pressure by a pressure increment and to increase the high time by a time increment, and (b) when false, the control module adjusts at least one of the supply pump and the plurality of valves to increase the FiO2 quantity.

3. The ventilator system according to claim 1, wherein if the SpO2 goal value is true, the command module communicates with the sensor array and ascertains the patient actual data array to ascertain a FiO2 goal value;

and

wherein when the FiO2 goal value (a) is true, the command module commands the control module to adjust at least one of the supply pump and the plurality of valves to decrease the FiO2 quantity, and (b) when false, the command module sets an initial weaning value to be true.

4. The ventilator system according to claim 1, wherein if the SpO2 goal value is false, the command module communicates with the sensor array and ascertains the patient actual data array to compute a recruitment value;

and

wherein when the recruitment value (i) is true, the control module generates a clinician alarm signal, and, (ii) is false the control module adjusts at least one of the supply pump and the plurality of valves to (a) increase the high pressure by a pressure increment, (b) increase the high time by a time increment, and (c) adjust the low time by another time increment.

5. The ventilator system according to claim 1, wherein if the SpO2 goal value is false, the command module communicates with the sensor array and ascertains the patient actual data array to compute an optimal end expiration lung volume value;

and

wherein if the optimal end expiration lung volume value (a) is true, the command module sets an oxygenation value to be true, and (b) if false, the command module (i) polls the sensor array to measure the peak expiratory flow rate, measure the truncation of gas flow, and computes an angle of deceleration of gas flow to select one of the time increments, (ii) sets a recruitment value to be true, and (iii) commands the control module to adjust at least one of the supply pump and the plurality of valves to decrease the low time by applying the selected time increment.

6. The ventilator system according to claim 1, wherein if the etCO2 goal value, the comparison between the spontaneous frequency and the machine respiratory frequency and the high time is false, the high pressure is determined;

and

wherein if the high pressure is determined to be (a) false, the command module commands the control module to adjust at least one of the supply pump and the plurality of valves by increasing at least one of the high time and the high pressure by at least one respective time increment and pressure increment and (b) true, the command module commands the control module to adjust at least one of the supply pump and the plurality of valves by increasing at least one of the high time by at least one respective time increment.

7. The ventilator system according to claim 1, wherein if the etCO2 goal value is false, the comparison between spontaneous frequency and the machine respiratory frequency is true and the high time is true the high pressure is determined;

and

wherein if high pressure value is determined to be (a) true, the command module commands the control module to set a recruitment value to be true and to adjust at least one of the supply pump and the plurality of valves by changing the high time by at least one respective time increment and (b) false, the command module commands the control module to adjust at least one of the supply pump and the plurality of valves by decreasing the high time and increasing the high pressure by at least one respective time increment and pressure increment.

8. The ventilator system according to claim 1, wherein the control module detected the etCO2 goal value to be true and the command module samples to ascertain a spontaneous frequency;

and

wherein when the spontaneous frequency (a) is false, the command module ascertains a tachypnea value that if true enables the command module to set a ventilation value to be true, and (b) is true, the command module ascertains an apnea value that (i) when true enables the command module to set the ventilation value to be true and (ii) when false enable the command module to set an airway pressure release ventilation weaning value to be true.

9. The ventilator system according to claim 1, wherein the control module detected the etCO2 goal value to be true and the command module samples the high pressure and sets a high pressure value and samples the spontaneous frequency;

and

wherein when the command module detects the spontaneous frequency and the high pressure value are true, the command module initiates a weaning by commanding the control module to adjust at least one of the supply pump and the plurality of valves to decrease the high pressure by a pressure increment and to increase the high time by a time increment.

10. The ventilator system according to claim 1, further comprising:

the at least one model patient data array further including predetermined weaning failure criteria that establish a FiO2 threshold, a SpO2 threshold, a spontaneous tidal volume, a minute ventilation quantity, and an airway occlusion pressure;

wherein the command module communicates with the data circuit to sample the sensor array and measure at least one of the patient actual data array elements and compares the elements to the predetermined weaning failure criteria to generate a weaning failure value; and

wherein when the command module determines (a) that the weaning failure value is true, the command module commands the control module to adjust at least one of the supply pump and the plurality of valves to increase the high pressure by a pressure increment and to decrease the high time by a time increment, and (b) that the weaning failure value is false, the command module repeatedly initiates cyclic weaning by commanding the control module to adjust at least one of the supply pump and the plurality of valves to decrease the high pressure and high time by a pressure and time increment.

11. The ventilator system according to claim 10, wherein each time the command module initiates another cyclic weaning, the command module ascertains the high pressure until a continuous positive airway pressure threshold is reached to enable the command module to set a continuous positive airway pressure value to be true.

12. The ventilator system according to claim 1, further comprising:

the at least one model patient data array further including a predetermined continuous positive airway pressure and a predetermined weaning failure criteria establishing a FiO2 threshold, a SpO2 threshold, a spontaneous tidal volume, a minute ventilation quantity, and an airway occlusion pressure;

wherein the command module communicates with the data circuit to sample the sensor array and measure at least one of the patient actual data array elements and compares the elements to the predetermined weaning failure criteria to generate a weaning failure value; and

wherein when the command module determines (a) that the weaning failure value is true, the command module commands the control module to adjust at least one of the supply pump and the plurality of valves to increase the continuous positive airway pressure, and (b) that the weaning failure value is false, the command module periodically decreases the continuous positive airway pressure until an extubate threshold pressure is reached.

13. The ventilator system according to claim 12, further comprising:

a high pressure wherein the high pressure is (a) false, the command module commands the control module to adjust at least one of the supply pump and the plurality of valves to adjust the continuous positive airway pressure based on the high pressure, and if (b) is true the command module commands the control module to adjust at least one of the supply pump and the plurality of valves to adjust to airway pressure release ventilation weaning.

14. A ventilator for use by a clinician in supporting a patient presenting pulmonary distress, comprising:

a controller including a display, input device, and a memory together in electrical communication with a data network, the controller incorporating a pressurized gas source in fluid communication with a gas network that includes at least two valves and supply and exhaust ports in communication with the patient;

a plurality of sensors in communication with the data network that includes at least one oxygen saturation sensor, at least one capnometer, at least one pressure gauge, and at least one gas flow rate meter in communication with at least one of the exhaust and supply ports;

a command routine resident in the memory being operative to drive the controller to adjustably actuate the pressurized gas source and at least one of the valves to establish a pressure volume flow rate in the gas network;

whereby the command routine displays prompts on the display for the clinician to enter settings via the input device at least one of (i) an automated initialization setting and (ii) a parameter to be stored in the memory that includes at least one of (a) a positive end expiratory pressure quantity, (b) a SpO2 quantity, (c) an etCO2 quantity, (d) a FiO2 quantity, (e) an high pressure, (f) a low pressure, (g) a high time, (h) a low time;

(i) a pressure increment, (j) a time increment, (k) a tidal volume, (l) a machine respiratory frequency, (m) a pressure-volume slope, (n) a trigger pressure and (o) occlusion pressure;

wherein the command routine receives settings from the clinician via the input device and commands the controller to actuate the pressurized gas source and commencing respiratory assistance to the patient whereby the gas circuit communicates with the patient using one each of the FiO2 quantity, the high and low pressure, and the high and low time;

wherein the command routine communicates with the plurality of sensors to measure patient actual data array elements of at least one of (i) a patient SpO2 quantity, (ii) a patient etCO2 quantity, (iii) a peak expiratory flow rate, (iv) an end expiratory lung volume and (v) spontaneous frequency; and

wherein the command routine compares the patient actual data array to at least one of the settings and computes at least one of a SpO2 goal value, an etCO2 goal value, and an optimal end expiratory lung volume.

15. The ventilator according to claim 14, wherein if the SpO2 goal value is false, the command routine communicates with the plurality of sensors and ascertains the patient actual data array to compute an optimal end expiration lung volume value;

and

wherein if the optimal end expiration lung volume value (a) is true, the command routine sets an oxygenation value to be true, and (b) if false, the command routine (i) polls the plurality of sensors to measure the peak expiratory flow rate and measure the truncation of gas flow and computes an angle of deceleration of gas flow to select one of the time increments, (ii) sets a recruitment value to be true, and (iii) commands the controller to adjust at least one of the pressurized gas source and the plurality of valves to decrease the low time by applying the selected time increment.

16. The ventilator according to claim 14, wherein if the etCO2 goal value, the comparison between the spontaneous frequency and the machine respiratory frequency and the high time is false the high pressure is determined;

and

wherein if the high pressure is determined to be (a) false, the command module commands the control module to adjust at least one of the supply pump and the plurality of valves by increasing at least one of the high time and the high pressure by at least one respective time increment and pressure increment and (b) true, the command module commands the control module to adjust at least one of the supply pump and the plurality of valves by increasing at least one of the high time by at least one respective time increment.

17. The ventilator system according to claim 14, wherein if the etCO2 goal value is false, the comparison between the spontaneous frequency and the machine respiratory frequency is true and the high time is true the high pressure is determined;

and,

wherein if high pressure value is determined to be (a) true, the command module commands the control module to set a recruitment value to be true and to adjust at least one of the supply pump and the plurality of valves by changing high time by at least one respective time increment and (b) false, the command module commands the control module to adjust at least one of the supply pump and the plurality of valves by decreasing the high time and increasing the high pressure by at least one respective time increment and pressure increment.

18. A means for ventilating a patient presenting respiratory distress to a clinician, comprising:

a means for communicating a pressurized gas to a patient and for exhausting gas from the patient;

a means for controlling the supplying means that includes a means for displaying information, a means for receiving input from the clinician, and a means for storing information;

a plurality of means for detecting physical conditions of the gas communicated to the patient by the supplying means that includes (a) at least one means for detecting a pressure, (b) at least one means for detecting a volume flow rate, (c) at least one means for detecting a concentration of oxygen, and (d) at least one means for detecting a concentration of carbon dioxide;

a means for instructing the means for controlling to adjustably communicate the pressurized gas with a variable pressurized volumetric flow rate and to detect the physical conditions of the gas, the instructing means residing on the means for storing information;

whereby the means for instructing the means for controlling prompts the clinician on the means for displaying to enter settings via the means for receiving input at least one of (i) an automated initialization setting and (ii) at least one parameter to be retained in the means for storing that includes at least one of (a) a positive end expiratory pressure quantity, (b) a SpO2 quantity, (c) an etCO2 quantity, (d) a FiO2 quantity, (e) an high pressure, (f) a low pressure, (g) a high time, (h) a low time;

(i) a pressure increment, (j) a time increment, (k) a tidal volume, (l) a machine respiratory frequency, (m) a pressure-volume slope, (n) a trigger pressure and (o) occlusion pressure;

wherein the means for instructing receives the settings from the clinician and commands the means for controlling to actuate the means for supplying to communicate the pressurized gas supply to the patient having physical conditions characterized by at least one each of the FiO2 quantity, the high and low pressure, and the high and low time;

wherein the means for instructing communicates with at least one of the plurality of means for detecting and measures patient actual data array elements of at least one of (i) a patient SpO2 quantity, (ii) a patient etCO2 quantity, (iii) a peak expiratory flow rate, (iv) an end expiratory lung volume and (v) spontaneous respiratory frequency; and

wherein the means for commanding compares the patient actual data array to at least one of the settings and computes at least one of a SpO2 goal value, an etCO2 goal value, and an optimal end expiratory lung volume.

19. The means for ventilating according to claim 18, wherein if the etCO2 goal value, the comparison between the spontaneous frequency and the machine respiratory frequency and the high time is false the high pressure is determined;

and

wherein if the high pressure is determined to be (a) false, the command module commands the control module to adjust at least one of the supply pump and the plurality of valves by increasing at least one of the high time and the high pressure by at least one respective time increment and pressure increment and (b) true, the command module commands the control module to adjust at least one of the supply pump and the plurality of valves by increasing at least one of the high time by at least one respective time increment.

20. The means for ventilating according to claim 18, wherein if the etCO2 goal value is false, the comparison between the spontaneous frequency and the machine respiratory frequency is true and the high time is true the high pressure is determined;

and,

wherein if high pressure value is determined to be (a) true, the command module commands the control module to set a recruitment value to be true and to adjust at least one of the supply pump and the plurality of valves by changing high time by at least one respective time increment and (b) false, the command module commands the control module to adjust at least one of the supply pump and the plurality of valves by decreasing the high time and increasing the high pressure by at least one respective time increment and pressure increment.

21. The means for ventilating according to claim 18, further comprising:

the at least one of (i) an automated initialization setting and (ii) at least one parameter further include predetermined weaning failure criteria establishing a FiO2 threshold, a SpO2 threshold, a spontaneous tidal volume, a minute ventilation quantity, and an airway occlusion pressure;

wherein the means for commanding communicates with the means for detecting and measures an actual value to compare with at least one of the predetermined weaning failure criteria to generate a weaning failure value; and

wherein when the means for commanding determines (a) that the weaning failure value is true, the means for commanding instructs the means for controlling to adjust the means for supplying to increase the high pressure by a pressure increment and to decrease the high time by a time increment, and (b) that the weaning failure value is false, the means for commanding repeatedly initiates a cyclic weaning by commanding the means for controlling to adjust the means for supplying to decrease the high pressure by a pressure increment.

22. The means for ventilating according to claim 21, wherein each time the means for commanding initiates another cyclic weaning, the means for commanding ascertains the high pressure and continues the cycle until a continuous positive airway pressure threshold is detected to enable the means for commanding to set a continuous positive airway pressure value to be true.

23. The means for ventilating according to claim 18, further comprising:

the at least one of (i) an automated initialization setting and (ii) at least one parameter further include predetermined weaning failure criteria establishing a FiO2 threshold, a SpO2 threshold, a spontaneous tidal volume, a minute ventilation quantity, and an airway occlusion pressure;

wherein the means for commanding communicates with the means for detecting and measures an actual value to compare with at least one of the predetermined weaning failure criteria to generate a weaning failure value; and

wherein when the means for commanding determines (a) that the weaning failure value is true, the means for commanding instructs the means for controlling to adjust the means for supplying to increase the continuous positive airway pressure, and (b) that the weaning failure value is false, the means for commanding periodically decreases the continuous positive airway pressure until an extubate threshold pressure is reached.

24. A method of operating a ventilator for use by a clinician in supporting a patient presenting pulmonary distress, comprising the steps of:

(a) furnishing a controller including a display, input device, and a memory together in electrical communication with a data network, the controller incorporating a supply pump in fluid communication with a gas network that includes at least two valves and supply and exhaust ports in communication with the patient;

furnishing a plurality of sensors in communication with the data network that includes at least one oxygen saturation sensor, at least one capnometer, at least one pressure gauge, and at least one gas flow rate meter in communication with at least one of the exhaust and supply ports; and

furnishing a command routine resident in the memory being operative to drive the controller to adjustably actuate the supply pump and at least one of the valves to establish a pressure volume flow rate in the gas network;

(b) entering settings via the input device including at least one of (i) an automated initialization setting and (ii) a parameter to be stored in the memory that includes at least one of (a) a positive end expiratory pressure quantity, (b) a SpO2 quantity, (c) an etCO2 quantity, (d) a FiO2 quantity, (e) an high pressure, (f) a low pressure, (g) a high time, (h) a low time;

(i) a pressure increment, (j) a time increment, (k) a tidal volume, (l) a machine respiratory frequency, (m) a pressure-volume slope, (n) a trigger pressure, and (o) a predetermined weaning failure criteria including at least one of a FiO2 threshold, a SpO2 threshold, a spontaneous tidal volume, a minute ventilation quantity, and an airway occlusion pressure;

(c) receiving in the command routine the settings from the clinician via the input device to command the controller to actuate the supply pump;

(d) commencing respiratory assistance to the patient whereby the gas circuit communicates with the patient using one each of the FiO2 quantity, the high and low pressure, and the high and low time;

(e) measuring patient actual data array elements, with the command routine communicating with the plurality of sensors, of at least one of (i) a patient SpO2 quantity, (ii) a patient etCO2 quantity, (iii) a peak expiratory flow rate, (iv) an end expiratory lung volume and (v) spontaneous respiratory frequency; and

(f) comparing via the command routine, the patient actual data array to at least one of the settings; and

(g) computing at least one of a SpO2 goal value, an etCO2 goal value, and an optimal end expiratory lung volume.

25. The method of ventilating a patient according to claim 24, further comprising th steps of:

(h) measuring and comparing at least one of the patient actual data array elements to the predetermined weaning failure criteria to generate a weaning failure value;

(i) determining when the weaning failure value is false initiating a cyclic weaning by adjusting at least one of the supply pump and the plurality of valves to decrease the high pressure by a pressure increment;

(j) modifying the high pressure until a continuous positive airway pressure threshold is reached; and

(k) periodically decreasing the continuous positive airway pressure until an extubate threshold pressure is reached.