Systems, methods and apparatus for respiratory support of a patient

• US 7,533,670 B1
• Filed: 09/20/2006
• Issued: 05/19/2009
• Est. Priority Date: 09/20/2005
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Wondka, Anthony, Kapust, Gregory, Freitag, Lutz
• Primary Examiner(s): Yu; Justine R
• Assistant Examiner(s): Dixon; Annette F
• Application Number:
  US11/523,519
• Publication Number:
  US 20090107494A1
• Time in Patent Office: 972 Days
• Field of Search: 128/200.26, 128/204.18, 128/204.25, 128/207.14, 128/207.17, 128/207.18, 128/200.24, 128/205.19, 128/206.11, 128/207.29, 60416401-16413
• US Class Current: 128/204.23
• CPC Class Codes: A61M 16/00 Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61H31/00
• CPC Class Codes: A61M 16/0006 with means for creating vibrations in patients' airways
• CPC Class Codes: A61M 16/0063 Compressors
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/0465 Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
• CPC Class Codes: A61M 16/0468 with valves at the proximal end limiting exhalation, e.g. during speaking or coughing air passages from trachea to oesophagus or to pharynx, artificial epiglottis A61F2/203
• 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 2016/0413 with detectors of CO2 in exhaled gases

Abstract

Spontaneous respiration is detected by sensors. An additional amount of oxygen is administered to the lungs via a jet gas current at the end of an inhalation procedure. Breathing volume, absorption of oxygen during inhalation, and clearance of carbon dioxide during exhalation are improved. If required, the exhalation procedure of the patient can be arrested or slowed by a countercurrent to avoid a collapse of the respiration paths. An apparatus including an oxygen pump can be connected to an oxygen source and includes a tracheal prosthesis that can be connected via a catheter. The respiration detections sensors are connected to a control unit for activating the oxygen pump. The tracheal prosthesis includes a tubular support body with a connection for the catheter, and the sensors are associated with the support body. The tracheal prosthesis and jet catheter are dimensioned so the patient can freely breathe and speak without restriction.

Claims

1. An apparatus for supplementing respiration of a spontaneously breathing patient comprising:

an oxygen-bearing gas source,

patient respiration sensors for detecting spontaneous respiration phases of the patient a catheter adapted to be inserted into the respiratory system of the patient and fluidly connected to the oxygen-bearing gas source, and

a control unit in communication with the patient respiration sensors, the control unit adapted and configured to determine a need for an additional amount of gas based on the patient'"'"'s need as determined by a measurement of the patient'"'"'s respiration and to control the oxygen-bearing gas source to deliver a volume of gas to the patient through the catheter in synchrony with a portion of the patient'"'"'s spontaneous breathing pattern when the patient needs respiratory support.

2. The apparatus of claim 1, wherein at least one of the patient respiration sensors are selected from the group consisting of:

thermistors, pressure sensors, silicone wire strain gauges, respibands, respitrace, transthoracical electrical impedance measuring devices, flow sensors at the mouth or nose, and capnometers.

3. The apparatus of claim 1, wherein the patient respiration sensors are used for ventilation control and connected to the control unit wirelessly.

4. The apparatus of claim 1, wherein the catheter is connected to a low profile tracheal prosthesis configured to be placed within a trachea without occluding the airway while maintaining tracheal patency and preventing the respiration sensor from contacting the tracheal wall.

5. The apparatus of claim 4, wherein the tracheal prosthesis further comprises prongs or petals that are configured to be positioned on at least one of an anterior wall of a trachea and or a neck surface of the patient and to secure the prosthesis in place.

6. The apparatus of claim 4, wherein the tracheal prosthesis further comprises an antibacterial, a drug, a lubricious coating, hydrogel anesthetics, a treatment to prevent granulation tissue, or a treatment to prevent mucous formation coating.

7. The apparatus of claim 1, wherein the catheter further comprises a jet nozzle.

8. The apparatus of claim 7, wherein an exit port of the catheter is substantially centered in the trachea though the use of coils or bends in the catheter configured to touch the walls of the trachea.

9. The apparatus of claim 7, wherein the catheter further comprises clips or balloons adapted to position the catheter in a tracheal lumen, wherein the clips or balloons are non-obstructive and do not obstruct an airway when inserted into a tracheal lumen.

10. The apparatus of claim 9, wherein the catheter has a single circumferential balloon or a plurality of balloons.

11. The apparatus of claim 9, wherein the clips are made of a resilient material.

12. The apparatus of claim 1, wherein the catheter comprises an inner lumen and an outer lumen each for gas flow.

13. The apparatus of claim 12, wherein the wall of the outer lumen comprises a plurality of gas exit ports that are configured to create airflow profiles in the trachea.

14. The apparatus of claim 13, wherein the plurality of ports are substantially circular, hexagonal, oval, or slits.

15. The apparatus of claim 13, wherein the catheter further comprises a flow regulator adapted to regulate the flow of oxygen-bearing gas through the ports.

16. The apparatus of claim 15, wherein the flow regulator is selected from the group consisting of:

a gliding sheath, shutters, louvers, and slats.

17. The apparatus of claim 1, wherein the apparatus is a modular component.

18. The apparatus of claim 1, wherein at least one sensor is a nanotechnology device.

19. The apparatus of claim 1, wherein oxygen-bearing gas from the oxygen-bearing gas source further comprises fragrances, aerosolized drugs, or water.

20. The apparatus of claim 1, wherein oxygen-bearing gas from the oxygen-bearing gas source is heated.

21. The apparatus of claim 1, wherein the control unit is configured to determine when a patient'"'"'s respiration is in need of mechanical support based on the information received by the control unit from the respiration sensors.

22. The apparatus of claim 1, wherein the sensors comprise at least two sensors and the two sensors are disposed at different locations.

23. The apparatus of claim 22, wherein the sensors comprise a first and a second sensor, and the first sensor is configured so that a signal response of a first sensor is dampened relative to a signal response of the second sensor, and further comprising a logic for comparing the signal responses of the first and second sensors for correcting signal drift, transient signals and artifacts.

24. The apparatus of claim 1, further comprising a gas pump operatively connected to the oxygen-bearing gas source, wherein the gas pump, oxygen-bearing gas source, and control unit are housed together.

25. The apparatus of claim 1, wherein the control unit is configured to determine a need for additional volume of gas based on input from the patient respiration sensors and is further configured to control the oxygen-bearing gas source to increase, decrease, switch-on or switch-off the delivery of the volume of gas based on the need determined.

26. A method for supplementing the respiration of a spontaneously breathing patient comprising the steps of:

inserting a catheter into the respiratory system of the patient so that the catheter does not hinder the patient'"'"'s ability to speak or breathe spontaneously through the upper airway,

determining the phases of spontaneous respiration of the patient with respiration sensors including beginning and end of breath phases,

administering a supplemental volume of oxygen-bearing gas based on the patient'"'"'s need as determined by a measurement of the patient'"'"'s respiration to the lungs at a gas flow speed of greater than 100 m/sec., wherein the delivery is synchronized with a portion of the patient'"'"'s spontaneous respiration phases.

27. The method of claim 26, wherein the respiration sensors are selected from the group consisting of:

thermistors, pressure sensors, silicone wire strain gauges, respibands, respitrace, transthoracical electrical impedance measuring devices, flow sensors at the mouth or nose, and capnometers.

28. The method of claim 26, further comprising connecting the catheter to a tracheal prosthesis that is configured to not occlude an airway.

29. The method of claim 28, further comprising securing the tracheal prosthesis in a trachea with prongs or petals, wherein the prongs or petals are positioned on an anterior wall of a trachea and or a neck surface of the patient and the prongs or petals secure the prosthesis in place.

30. The method of claim 28, further comprising supplying an antibacterial, a drug, a lubricious coating, hydrogel anesthetics, a treatment to prevent granulation tissue, or a treatment to prevent mucous formation to the patient by providing a tracheal prosthesis coated thereof.

31. The method of claim 26, wherein the step of inserting the catheter comprises inserting a catheter having an exit port, wherein the exit port of the catheter is substantially centered in the patient'"'"'s trachea.

32. The method of claim 31, wherein the step of inserting the catheter having an exit port comprises substantially centering the exit port of the catheter in the trachea through the use of coils or bends in the catheter touching the walls of the trachea.

33. The method of claim 31, wherein the step of inserting the catheter having an exit port comprises substantially centering the exit port of the catheter in the trachea though the use of clips or balloons attached to the catheter and the clips or balloons are configured to not seal or obstruct an airway.

34. The method of claim 33, wherein the step of substantially centering the catheter comprises substantially centering a catheter having a single circumferential balloon or a plurality of balloons.

35. The method of claim 33, wherein the step of substantially centering the catheter comprises substantially centering a catheter having clips made of a resilient material.

36. The method of claim 26, wherein the step of inserting the catheter comprises inserting the catheter into the patient'"'"'s respiratory system by way of the mouth or nose.

37. The method of claim 26, wherein the step of inserting the catheter comprises inserting a catheter having an outer lumen and an inner lumen, and wherein a wall of the outer lumen comprises a plurality of gas exit ports that are configured to create airflow profiles in a trachea.

38. The method of claim 37, wherein the step of administering comprises administering the oxygen-bearing gas through the inner lumen during inhalation and administering the oxygen-bearing gas through the outer lumen during exhalation.

39. The method of claim 26, further comprising applying vibratory flow to improve mucus clearance.

40. The method of claim 26, further comprising sensing high pressure in the trachea and shutting off the administration of oxygen-bearing gas.

41. The method of claim 26, wherein the step of administering a supplemental amount of oxygen-bearing gas comprises administering a supplemental amount of oxygen-bearing gas selected from the group consisting of:

substantially pure oxygen, mixtures of oxygen and nitrogen, mixtures of oxygen and inert gases, ambient air, and various combinations thereof.

42. The method of claim 41, wherein the step of administering a supplemental amount of oxygen-bearing gas further comprises administering a supplemental amount of oxygen-bearing gas comprising fragrances, aerosolized drugs, or water.

43. The method of claim 41, further comprising heating the oxygen-bearing gas.

44. The method of claim 26, further comprising determining when the patient'"'"'s respiration is in need of mechanical support, based on information received by the control unit from the breath sensors.

45. The method of claim 44, wherein the step of administering a supplemental amount of oxygen-bearing gas comprises administering a supplemental amount of oxygen-bearing as to the lungs when the patient is in need of mechanical support.

46. The method of claim 44, further comprising providing a continuous flow of oxygen-bearing gas in addition to administering a supplemental amount of oxygen-bearing gas.

47. The method of claim 26, wherein the supplemental oxygen-bearing gas is administered simultaneously with a continuous flow of oxygen-bearing gas.

48. A method for supplementing the respiration of a spontaneously breathing patient comprising the steps of:

inserting an oxygen-bearing gas delivery device into the respiratory system of the patient,

detecting spontaneous respiration of the patient with respiration sensors,

identifying an inhalation phase and an exhalation phase using information from the respiration sensors,

synchronizing delivery of a volume of oxygen-bearing gas based on the patient'"'"'s need as determined by a measurement of the patient'"'"'s respiration to the patient during an inhalation phase to augment inspiration or during an exhalation phase to augment exhalation, and wherein the delivered volume of the oxygen-bearing gas is increased, decreased, switched-on or switched-off based on feedback from the respiration sensors.

49. The method of claim 48, further comprising:

determining at or near a peak of the inhalation phase whether the volume of oxygen-bearing gas is needed by the patient.

50. The method of claim 48, further comprising:

determining at or near a peak of the exhalation phase whether more carbon dioxide needs to be exhaled by the patient.

51. The method of claim 48, further comprising:

detecting gas composition in the airway to determine whether to adjust the delivery of the supplemental volume of oxygen-bearing gas.

52. A device for supplementing the respiration of a spontaneously breathing patient comprising

sensors for monitoring the spontaneous respiration of the patient

a catheter configured to be inserted into the respiratory system of the patient,

a control unit communicating with the sensors configured to identify an inhalation and an exhalation phase of the patient'"'"'s spontaneous respiration and the need for supplemental gas volume based on the patient'"'"'s need as determined by a measurement of the patient'"'"'s respiration wherein the control unit is further configured to administer a supplemental amount of oxygen-bearing gas through the catheter synchronously with either an inhalation phase or an exhalation phase, and

wherein the supplemental volume of the oxygen-bearing gas is increased, decreased, switched-on or switched-off based on feedback from the sensors.

53. The device of claim 52, wherein the supplemental volume of oxygen-bearing gas is administered at a gas flow speed of greater than 100 m/s.

54. The device of claim 52, wherein the supplemental volume of oxygen-bearing gas is administered at a gas flow speed of between about 100 m/s to about 300 m/s.

55. A system for supplementing the respiration of a spontaneously breathing patient, comprising:

a transtracheal catheter adapted for placement in an airway of a patient and comprising at least one respiration sensor, wherein the transtracheal catheter is configured to not obstruct an airway of the patient; and

a wearable mobile respiratory device comprising;

a control unit in communication with the respiration sensor, the control unit configured to determine the need for additional volume based on the patient'"'"'s need as determined by a measurement of the patient'"'"'s respiration and to control the delivery of a volume of supplemental gas to the patient in synchrony with a portion of the patient'"'"'s spontaneous breathing pattern when the need for breath augmentation is determined.

56. The system of claim 55, wherein the catheter is connected to a tracheal prosthesis configured to be placed within a trachea without occluding the airway while maintaining tracheal patency and preventing the respiration sensor from contacting the tracheal wall.