Vacuum and positive pressure ventilation systems and methods for intrathoracic pressure regulation

• US 8,967,144 B2
• Filed: 06/21/2010
• Issued: 03/03/2015
• Est. Priority Date: 06/19/2009
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Advanced Circulatory Systems, Inc. (Asahi Kasei Corporation)
• Inventors: Lurie, Keith, Metzger, Anja, Krueger, Kurt, Voss, Greg
• Primary Examiner(s): Yu, Justine
• Assistant Examiner(s): SUL, DOUGLAS YOUNG
• Application Number:
  US12/819,959
• Publication Number:
  US 20100319691A1
• Time in Patent Office: 1,716 Days
• Field of Search: 128/205.19, 128/204.18, 128/204.21, 128/205.24, 604 41- 44
• US Class Current: 128/205.19
• CPC Class Codes: A61H 2230/06 Heartbeat rate
• CPC Class Codes: A61H 2230/30 Blood pressure A61H2230/04 takes precedence
• CPC Class Codes: A61H 2230/40 Respiratory characteristics
• CPC Class Codes: A61H 31/02 "Iron-lungs" , i.e. involving chest expansion by applying underpressure thereon, whether or not combined with gas breathing means
• CPC Class Codes: A61M 16/0003 Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 16/0009 with sub-atmospheric pressure, e.g. during expiration
• CPC Class Codes: A61M 16/0012 by Venturi means
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0078 Breathing bags
• CPC Class Codes: A61M 16/009 Removing used or expired gases or anaesthetic vapours filtering, sterilising or disinfecting the exhaust air in drainage systems A61M1/784; bacterial filters in the expiratory path A61M16/1065
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/085 Gas sampling
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/1065 in the expiratory path
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/201 : Controlled valves
• CPC Class Codes: A61M 16/202 : electrically actuated
• CPC Class Codes: A61M 16/205 : used for exhalation control
• CPC Class Codes: A61M 16/208 : Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2016/0027 : pressure meter
• CPC Class Codes: A61M 2016/0036 : in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/102 : Measuring a parameter of the content of the delivered gas
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2230/06 : Heartbeat rate only
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/208 : pH-value
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/42 : Rate
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61N 1/3601 : of respiratory organs
• CPC Class Codes: A61N 1/39 : Heart defibrillators
• CPC Class Codes: A61N 1/39044 : in combination with cardiopulmonary resuscitation [CPR] therapy

Abstract

Medical techniques include systems and methods for administering a positive pressure ventilation, a positive end expiratory pressure, and a vacuum to a person. Approaches also include treating a person with an intrathoracic pressure regulator so as to modulate or upregulate the autonomic system of the person, and treating a person with a combination of an intrathoracic pressure regulation treatment and an intra-aortic balloon pump treatment.

Claims

1. An intrathoracic pressure regulator system for use in treating a patient, the system comprising:

a patient port adapted to fluidly communicate with the patient;

a ventilator port that fluidly communicates with a ventilator mechanism for facilitating a positive pressure ventilation procedure administered to the patient via an inspiratory chamber and the patient port;

a vacuum port that fluidly communicates with a vacuum mechanism for facilitating a vacuum procedure administered to the patient via an expiratory chamber and the patient port; and

a valve for controlling gas flow, wherein during administration of the positive pressure ventilation procedure the valve allows gas flow between the ventilator port and the patient port and inhibits gas flow between the vacuum port and the patient port, and during administration of the vacuum procedure the valve inhibits gas flow between the ventilator port and the patient port and allows gas flow between the vacuum port and the patient port by allowing expired gas to pass from the patient port through an expiratory chamber to the vacuum port, and wherein the valve is configured to regulate, throughout consecutive breathing cycles, expiratory pressure in the patient port between 0 and −

20 cm H₂O;

wherein the patient port comprises an inspiratory lumen that is at least partially contained within an expiratory lumen, wherein the inspiratory lumen is sealed from the expiratory lumen, and wherein an inspiratory path traverses the expiratory chamber and communicatively couples with the inspiratory lumen.

2. The system according to claim 1, further comprising:

a positive end expiratory pressure mechanism in operative association with the valve,

wherein the valve further allows gas flow between the positive end expiratory pressure mechanism and the patient port during administration of a positive end expiratory pressure treatment that occurs either before or after administration of the vacuum procedure.

3. The system according to claim 1, further comprising:

a pressure sensor in fluid communication with the patient port,

wherein the pressure sensor indicates a positive pressure application during administration of the positive pressure ventilation procedure and a negative pressure application during administration of the vacuum procedure.

4. The system according to claim 1, wherein upon initiation of the positive pressure ventilation procedure the valve operates to inhibit gas flow between the ventilator port and the patient port and to inhibit gas flow between the vacuum port and the patient port.

5. The system according to claim 1, wherein the ventilator mechanism comprises an anesthesia machine.

6. An intrathoracic pressure regulator system for use in treating a patient, the system comprising:

a processor that accepts an operator selection input that designates a member selected from the group consisting of a circulatory assist mode, a ventilation mode, and a continuous positive airway pressure mode; and

a manifold assembly in operative association with the processor, the manifold assembly comprising;

an oxygen inlet port in fluid communication with an inspiratory chamber, wherein the oxygen inlet port receives oxygen from an oxygen source;

an air inlet port in fluid communication with the inspiratory chamber, wherein the air inlet port receives air from an air source;

an expiratory gas outlet port in fluid communication with an expiratory chamber, wherein the expiratory gas outlet port allows expired gas to pass therethrough toward a negative pressure mechanism;

a patient circuit interface having an inspiratory lumen adapted to transmit air and oxygen toward the patient and an expiratory lumen adapted to transmit air expired gas away from the patient;

an inspiratory control valve assembly that controls gas flow between the inspiratory chamber and the inspiratory lumen; and

an expiratory control valve assembly that controls gas flow between the expiratory chamber and the expiratory gas outlet port;

wherein the patient port comprises an inspiratory lumen that is at least partially contained within an expiratory lumen, wherein the inspiratory lumen is sealed from the expiratory lumen, and wherein an inspiratory path traverses the expiratory chamber and communicatively couples with the inspiratory lumen;

a fixed or adjustable negative pressure mechanism adapted to deliver a negative pressure treatment to the patient via the expiratory lumen when the system is in a circulatory assist mode; and

a member selected from the group consisting of a positive pressure ventilation mechanism adapted to deliver a positive pressure ventilation treatment to the patient via the inspiratory lumen when the system is in a ventilation mode, and an adjustable continuous positive airway pressure mechanism adapted to deliver an adjustable continuous positive airway pressure treatment to the patient via the expiratory lumen when the system is in a continuous positive airway pressure mode.

7. The system according to claim 6, wherein the system comprises the positive pressure ventilation mechanism and the adjustable continuous positive airway pressure mechanism.

8. The system according to claim 6, further comprising:

a positive end expiratory pressure mechanism adapted to deliver a positive end expiratory pressure treatment to the patient.

9. The system according to claim 6, further comprising:

a user display; and

a sensor mechanism selected from the group consisting of a physiological sensor and a mechanical sensor,

wherein the processor transmits display instructions to the user display based on patient information received from the sensor mechanism for displaying information related to CPR quality or circulation.

10. The system according to claim 9, wherein the processor transmits display instructions to the user display based on patient feedback information received from the sensor mechanism, and wherein the display instructions relate to CPR quality during administration of a CPR treatment.

11. The system according to claim 9, wherein the processor transmits display instructions to the user display based on patient feedback information received from the sensor mechanism, and wherein the display instructions relate to circulation during administration of a non-CPR treatment.

12. The system according to claim 6, wherein the ventilator mechanism comprises an anesthesia machine.

13. The system according to claim 6, wherein the controlled gas flow regulates expiratory pressure between 0 and −

20 cm H₂O throughout consecutive breathing cycles.

14. The system according to claim 6, wherein the inspiratory chamber comprises a first planar chamber and the expiratory chamber comprises a second planar chamber, and wherein the first planar chamber is parallel to and not in fluid communication with the second planar chamber.

15. A method of providing an intrathoracic pressure regulation treatment to a patient that is suffering from or at risk of developing sepsis, shock, heart failure, cardiac arrest, acute respiratory distress syndrome, polytrauma, head disease, elevated hepatic or portal vein pressures, bleeding during abdominal, head and neck surgery, or insufficient circulation during open heart surgery, the method comprising:

administering a positive pressure ventilation generated by a ventilator mechanism from an inspiratory lumen to the person'"'"'s airway via a patient port of an intrathoracic pressure regulator system;

administering a vacuum generated by a vacuum mechanism from an expiratory lumen to the person'"'"'s airway via an expiratory chamber that directs gas from the patient port of the intrathoracic pressure regulator system toward the vacuum mechanism;

wherein the inspiratory lumen is at least partially contained within the expiratory lumen, wherein the inspiratory lumen is sealed from the expiratory lumen, and wherein an inspiratory path traverses the expiratory chamber and communicatively couples with the inspiratory lumen; and

wherein during administration of the positive pressure ventilation a fluid control valve of the intrathoracic pressure regulator system allows gas flow between the ventilator mechanism and the patient port and inhibits gas flow between the vacuum mechanism and the patient port, and during administration of the vacuum the fluid control valve of the intrathoracic pressure regulator system inhibits gas flow between the ventilator mechanism and the patient port and allows gas flow between the vacuum mechanism and the patient port.

16. The method according to claim 15, further comprising:

administering a positive end expiratory pressure to the person'"'"'s airway subsequent to the administration of the positive pressure ventilation, wherein the vacuum is administered to the patient'"'"'s airway subsequent to the administration of the positive end expiratory pressure.

17. The method according to claim 15, further comprising:

administering a positive end expiratory pressure to the person'"'"'s airway subsequent to the administration of the vacuum, wherein the vacuum is administered to the patient'"'"'s airway subsequent to the administration of the positive pressure ventilation.

18. The method according to claim 15, further comprising:

displaying an indication of a positive pressure application during administration of the positive pressure ventilation procedure and an indication of a negative pressure application during administration of the vacuum procedure.

19. A method of providing an intrathoracic pressure regulation treatment to a patient that is suffering from or at risk of developing sepsis, shock, heart failure, cardiac arrest, acute respiratory distress syndrome, polytrauma, head disease, elevated hepatic or portal vein pressures, bleeding during abdominal, head and neck surgery, or insufficient circulation during open heart surgery, the method comprising:

administering a fixed or adjustable negative pressure treatment to the patient via an expiratory lumen of an intrathoracic pressure regulator system when the system is in a circulatory assist mode, wherein the negative pressure treatment does not exceed a negative airway pressure limit of about −

12 cm H₂O throughout consecutive breathing cycles; and

administering a positive pressure ventilation treatment to the patient via an inspiratory lumen of the intrathoracic pressure regulator system when the system is in a ventilation mode, or administering an adjustable continuous positive airway pressure treatment to the patient via the expiratory lumen of the intrathoracic pressure regulator system when the system is in a continuous positive airway pressure mode;

wherein the inspiratory lumen is at least partially contained within the expiratory lumen, wherein the inspiratory lumen is sealed from the expiratory lumen, and wherein an inspiratory path traverses an expiratory chamber and communicatively couples with the inspiratory lumen.

20. The method according to claim 19, further comprising:

administering a positive end expiratory pressure treatment to the patient with a positive end expiratory pressure mechanism of the intrathoracic pressure regulator system.

21. The method according to claim 19, wherein the method comprises administering the positive pressure ventilation treatment to the patient via the inspiratory lumen of the intrathoracic pressure regulator system when the system is in the ventilation mode, and administering a positive end expiratory pressure to the person'"'"'s airway subsequent to the administration of the positive pressure ventilation, wherein the negative pressure treatment is administered to the patient'"'"'s airway subsequent to the administration of the positive end expiratory pressure.

22. The method according to claim 19, wherein the method comprises administering the positive pressure ventilation treatment to the patient via the inspiratory lumen of the intrathoracic pressure regulator system when the system is in the ventilation mode, and administering a positive end expiratory pressure to the person'"'"'s airway subsequent to the administration of the negative pressure treatment, wherein the negative pressure treatment is administered to the patient'"'"'s airway subsequent to the administration of the positive pressure ventilation.

23. The method according to claim 19, further comprising:

displaying information related to CPR quality on a user display of the intrathoracic pressure regulator system during administration of a CPR treatment.

24. The method according to claim 19, further comprising:

displaying information related to circulation on a user display of the intrathoracic pressure regulator system during administration of a non CPR treatment.

25. The method according to claim 19, wherein the administering step comprises administering the fixed or adjustable negative pressure treatment to the patient via an expiratory chamber that directs gas from the expiratory lumen toward a negative pressure mechanism.