Tracheal gas insufflation bypass and phasic delivery system and method

• US 6,269,813 B1
• Filed: 01/15/1999
• Issued: 08/07/2001
• Est. Priority Date: 01/15/1999
• Status: Expired due to Term

• Current Assignee: RIC INVESTMENTS LLC (Koninklijke Philips N.V.)
• Original Assignee: Respironics Incorporated (Koninklijke Philips N.V.)
• Inventors: Sawyer, Jeffrey T., Weadley, Michael V., Fitzgerald, Peter M.
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US09/232,277
• Time in Patent Office: 935 Days
• Field of Search: 128/200.26, 128/207.14, 128/207.16, 128/207.29, 128/205.24, 128/912
• US Class Current: 128/207.16
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/0427 with removable and re-insertable liner tubes, e.g. for cleaning
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/1075 by influencing the temperature A61M16/1045 takes precedence
• CPC Class Codes: A61M 16/16 Devices to humidify the respiration air A61M16/1045 takes precedence
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/202 electrically actuated
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2016/0042 in the expiratory circuit
• CPC Class Codes: Y10S 128/912 Connections and closures for tubes delivering fluids to or from the body

Abstract

Tracheal gas insufflation (TGI) therapy is performed by a bypass valve and a controller which control a flow of TGI gas to a TGI catheter inserted into an endotracheal tube in the tracheal of a patient. The bypass valve is activated into a pass-through state to admit the TGI gas into the catheter and into a bypass state to divert the TGI gas from the TGI catheter. Potentially dangerous over-pressure may be sensed and the TGI gas flow terminated, but then quickly resumed after the over-pressure condition passes. Selectively applying and diverting the TGI gas allows phasic TGI therapy to be performed using heated and humidified gas and also allows the heat and humidity levels of the TGI gas to be maintained during continuous TGI therapy.

Claims

1. A tracheal gas insufflation (TGI) system, comprising:

a source of breathing gas;

a TGI catheter coupled to the source of breathing gas and adapted to deliver a flow of breathing gas to an airway of a patient;

a controllable bypass valve operatively connected to the TGI catheter and operative in a pass-through state to communicate the flow of breathing gas from the source of breathing gas to an airway of a patient, and operative in a bypass state to divert the flow of breathing gas from the TGI catheter;

a controller connected to selectively activate the bypass valve into the pass-through state or the bypass state; and

a pressure sensor operatively connected to the TGI catheter and adapted to supply to the controller a pressure signal related to a pressure in the TGI catheter, and wherein the controller activates the bypass valve into the bypass state in response to the pressure signal exceeding a predetermined value.

2. The TGI system as defined in claim 1, wherein the controller delivers a pneumatic control signal to activate the bypass valve.

3. The TGI system as defined in claim 2, wherein the source of breathing gas includes a blender adapted to combine air and oxygen to produce the flow of breathing gas.

4. The TGI system as defined in claim 1, further comprising a control selector associated with the controller to establish a flow value related to a flow of breathing gas in the TGI catheter and a pressure value related to a maximum pressure level in a patient'"'"'s lungs during operating of the TGI system, and wherein the controller calculates the predetermined value based on the flow value and the pressure value.

5. The TGI system as defined in claim 2, wherein the bypass valve comprises:

a housing; and

a piston member positioned within the housing and moveable between a first position establishing the pass-through state and a second position establishing the bypass state.

6. The TGI system as defined in claim 1, further comprising a humidifier coupled to the TGI catheter to humidify the flow of breathing gas.

7. The TGI system as defined in claim 6 wherein the humidifier includes a humidifying chamber adapted to receive the flow of breathing gas and to contain a pool of water from which humidity is taken up into the flow of breathing gas.

8. The TGI system as defined in claim 1, further comprising a heating element associated with the TGI catheter to heat the flow of breathing gas.

9. The TGI system as defined in claim 8, further comprising a humidifier coupled to the TGI catheter to humidify the flow of breathing gas, and wherein the heating element and humidifier are controlled so as to heat and humidify the flow of breathing gas to predetermined levels.

10. The TGI system as defined in claim 8, wherein the source of breathing gas includes:

a source of pressurized breathing gas for providing the flow of breathing gas; and

a tube adapted to deliver the flow of breathing gas from the source of pressurized gas the bypass valve, and wherein the heating element includes a wire extending in the tube to heat the flow of breathing gas passing through the tube.

11. The TGI system as defined in claim 1, wherein, responsive to being in the pass-through state, the controller causes the bypass valve to continuously communicate the flow of breathing gas from the source of breathing gas to an airway of a patient via the TGI catheter regardless of such a patient'"'"'s respiratory cycle.

12. The TGI system as defined in claim 1, wherein the controller communicates the flow of breathing gas from the source of breathing gas to an airway of a patient via the TGI catheter during at least a portion of an exhalation phase of such a patient'"'"'s respiratory cycle by placing the bypass valve in the pass-through state and prevents delivery of the flow of breathing gas to an airway of such a patient during a remaining portion of such a patient'"'"'s respiratory cycle by placing the bypass valve in the bypass state.

13. The TGI system as defined in claim 2, further comprising means for detecting an exhalation phase of a patient'"'"'s respiratory cycle, and wherein the controller activates the bypass valve in the pass-through state during at least a portion of the exhalation phase and activates the bypass valve in the bypass state during a remaining portion of a respiratory cycle.

14. The TGI system as defined in claim 2, wherein the controller is further operative to respond to an exhalation phase of a plurality of consecutive respiratory cycles of a patient and to activate the bypass valve into the pass-through state during a predetermined portion of each exhalation phase of each respiratory cycle and to activate the bypass valve into the bypass state during a remaining portion of each respiratory cycle.

15. The TGI system as defined in claim 1, further comprising a connector coupled to the TGI catheter to allow for selective alternative insertion of the TGI catheter and a second element into an endotracheal tube inserted in a trachea of a patient.

16. A tracheal gas insufflation (TGI) system, comprising:

a source of breathing gas;

a TGI catheter coupled to the source of breathing gas and adapted to deliver a flow of breathing gas to an airway of a patient;

a controllable bypass valve operatively connected to the TGI catheter and operative in a pass-through state to communicate the flow of breathing gas from the source of breathing gas to an airway of a patient, and operative in a bypass state to divert the flow of breathing gas from the TGI catheter, wherein the bypass valve comprises;

a housing, and

a piston member positioned within the housing and moveable between a first position establishing the pass-through state and a second position establishing the bypass state,

an inlet port adapted to receive the flow of breathing gas from the source of breathing gas,

an outlet port adapted to supply the flow of breathing gas from the housing to the TGI catheter for delivery to an airway of a patient, and

a vent port, wherein the inlet port is in fluid communication with the outlet port and is not in fluid communication with the vent port responsive to the piston being in the first position, and wherein the inlet port is in fluid communication with the vent port and is not in fluid communication with the outlet port responsive to the piston being in the second position; and

a controller connected to selectively activate the bypass valve into the pass-through state or the bypass state.

17. A method of providing a tracheal gas insufflation (TGI) therapy comprising the steps of:

communicating a flow of breathing gas from a source of breathing gas to an airway of a patient via a TGI catheter;

providing a controllable bypass valve operatively connected to the TGI catheter, wherein the bypass valve is selectively operative in a pass-through state to communicate the flow of breathing gas from the source of breathing gas to an airway of a patient and a bypass state to divert the flow of breathing gas from the TGI catheter so that the flow of breathing gas is not delivered to an airway of such a patient; and

selectively activating the bypass valve into the pass-through state or the bypass state, wherein selectively activating the bypass valve further comprising the steps of;

monitoring a pressure in the TGI catheter,

comparing the pressure in the TGI catheter to a threshold pressure, and

diverting the flow of breathing gas from the catheter via the bypass valve by activating the bypass valve in the bypass state responsive to the pressure in the catheter being greater than the threshold pressure.

18. The method as defined in claim 17, wherein communicating a flow of breathing gas includes continuously delivering the flow of breathing gas from the source of breathing gas to an airway of a patient via the TGI catheter during operation of the TGI system regardless of a phase of such a patient'"'"'s respiratory cycle.

19. The method as defined in claim 17, further comprising the steps of:

heating and humidifying the flow of breathing gas before communicating the flow of breathing gas to an airway of a patient.

20. The method as defined in claim 17, wherein communicating a flow of breathing gas includes:

delivering the flow of breathing gas to an airway of a patient only during a predetermined portion of an exhalation phase; and

diverting the flow of breathing gas flow from the catheter during the remaining portion of each respiratory cycle.

21. A system for providing a tracheal gas insufflation (TGI) therapy to a patient in conjunction with a primary pressure support system that delivers a primary flow of breathing gas to such a patient comprising:

gas flow generating means for providing a flow of breathing gas in conjunction with a primary pressure support system;

delivering means for communicating the flow of breathing gas from the gas flow generating means to an airway of a patient;

bypassing means for selectively diverting the flow of breathing gas from the delivering means so that the flow of breathing gas is not communicated to an airway of a patient;

controlling means for selectively causing the bypass means to divert the flow of breathing gas from the delivery means

means for establishing a threshold pressure for a pressure of the flow of breathing gas in the delivery means; and

means for determining a pressure of the flow of gas in the delivery means, wherein the controlling means compares the pressure of the flow of gas in the delivery means with the threshold pressure and causes the bypass means to divert the flow of breathing gas from the delivery means responsive to the pressure of the flow of gas in the delivery means exceeding the threshold pressure.

22. The system according to claim 21, further comprising at least one of:

heating means for heating the flow of breathing gas; and

humidifying means for humidifying the flow of breathing gas.

23. A system for providing breathing gas to a patient comprising:

(a) a primary pressure support system comprising;

(1) a pressure generator adapted to generate a primary flow of breathing gas, and

(2) a patient circuit coupled to the pressure generator and adapted to carry the primary flow of breathing gas to an airway of a patient; and

(b) a tracheal gas insufflation (TGI) system comprising;

(1) a source of TGI gas;

(2) a TGI catheter coupled to the source of TGI gas and adapted to deliver a flow of TGI gas to an airway of a patient in conjunction with the primary flow of breathing gas;

(3) a controllable bypass valve operatively connected to the TGI catheter and operative in a pass-through state to communicate the flow of TGI gas from the source of TGI gas to an airway of a patient, and operative in a bypass state to divert the flow of TGI gas from the TGI catheter, and

(4) a controller connected to selectively activate the bypass valve into the pass-through state or the bypass state.

24. The system according to claim 23, further comprising a pressure sensor operatively connected to the TGI catheter and adapted to supply to the controller a pressure signal related to a pressure in the TGI catheter, and wherein the controller activates the bypass valve into the bypass state in response to the pressure signal exceeding a predetermined value.

25. The system according to claim 23, further comprising a humidifier coupled to the TGI catheter to humidify the flow of TGI gas.

26. The system according to claim 23, further comprising a heating element associated with the TGI catheter to heat the flow of TGI gas.

27. The system according to claim 26, further comprising a humidifier coupled to the TGI catheter to humidify the flow of TGI gas, and wherein the heating element and humidifier are controlled so as to heat and humidify the flow of TGI gas to predetermined levels.

28. The system according to claim 23, wherein, responsive to being in the pass-through state, the controller causes the bypass valve to continuously communicate the flow of TGI gas from the source of breathing gas to an airway of a patient via the TGI catheter regardless of such a patient'"'"'s respiratory cycle.

29. The system according to claim 23, wherein the controller communicates the flow of TGI gas from the source of TGI gas to an airway of a patient via the TGI catheter during at least a portion of an exhalation phase of such a patient'"'"'s respiratory cycle by placing the bypass valve in the pass-through state and prevents delivery of the flow of TGI gas to an airway of such a patient during a remaining portion of such a patient'"'"'s respiratory cycle by placing the bypass valve in the bypass state.

30. The system according to claim 23, further comprising means for detecting an exhalation phase of a patient'"'"'s respiratory cycle, and wherein the controller activates the bypass valve in the pass-through state during at least a portion of the exhalation phase and activates the bypass valve in the bypass state during a remaining portion of a respiratory cycle.

31. The system according to claim 23, wherein the controller is further operative to respond to an exhalation phase of a plurality of consecutive respiratory cycles of a patient and to activate the bypass valve into the pass-through state during a predetermined portion of each exhalation phase of each respiratory cycle and to activate the bypass valve into the bypass state during a remaining portion of each respiratory cycle.