Methods, systems and devices for improving ventilation in a lung area

• US 7,588,033 B2
• Filed: 06/17/2004
• Issued: 09/15/2009
• Est. Priority Date: 06/18/2003
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Wondka, Anthony David
• Primary Examiner(s): Douglas; Steven O
• Application Number:
  US10/870,849
• Publication Number:
  US 20050005936A1
• Time in Patent Office: 1,916 Days
• Field of Search: 128/200.26, 128/207.14, 128/207.15, 128/207.16, 604/516, 604/518, 604/514, 604/509, 604/48, 604/28, 604/35, 424/423, 607/99, 600/114, 600/116, 606/108
• US Class Current: 128/207.14
• 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 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0404 with means for selective or partial lung respiration
• CPC Class Codes: A61M 16/042 with separate conduits for in-and expiration gas, e.g. for limited dead volume
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 16/0445 Special cuff forms, e.g. undulated
• CPC Class Codes: A61M 16/0459 one cuff behind another
• CPC Class Codes: A61M 16/0465 Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
• CPC Class Codes: A61M 16/0486 Multi-lumen tracheal tubes
• CPC Class Codes: A61M 16/0672 Nasal cannula assemblies for oxygen therapy
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/103 the CO2 concentration
• CPC Class Codes: A61M 2205/8225 using incorporated gas cartridges for the driving gas
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: A61M 2230/432 partial CO2 pressure (P-CO2)

Abstract

Methods, systems and devices are described for new modes of ventilation in which specific lung areas are ventilated with an indwelling trans-tracheobronchial catheter for the purpose of improving ventilation and reducing hyperinflation in that specific lung area, and for redistributing inspired air to other healthier lung areas, for treating respiratory disorders such as COPD, ARDS, SARS, CF, and TB. Trans-Tracheobronchial Segmental Ventilation (TTSV) is performed on either a naturally breathing or a mechanical ventilated patient by placing a uniquely configured indwelling catheter into a bronchus of a poorly ventilated specific lung area and providing direct ventilation to that area. The catheter can be left in place for extended periods without clinician attendance or vigilance. Ventilation includes delivery of respiratory gases, therapeutic gases or agents and evacuation of stagnant gases, mixed gases or waste fluids. Typically the catheter'"'"'s distal tip is anchored without occluding the bronchus but optionally may intermittently or continuously occlude the bronchus. TTSV is optionally performed by insufflation only of the area, or by application of vacuum to the area, can include elevating or reducing the pressure in the targeted area to facilitate stagnant gas removal, or can include blocking the area to divert inspired gas to better functioning areas.

Claims

1. A method of ventilating a patient, the method comprising:

placing a percutaneous transtracheal ventilation catheter in an airway of the patient so that the catheter is anchored to allow extended use without vigilance and so that the patient'"'"'s airway is patent to allow spontaneous breathing around the catheter;

attaching the catheter to a ventilator external to the patient, wherein the ventilator is a wear-able ventilator; and

ventilating the patient through the catheter by delivering gas at a positive pressure and flow rate sufficient to increase lung pressure.

30. The method as in claim 1, wherein the flow rate is set at a rate sufficient to achieve a desired volume output, wherein the desired volume output is sufficient to achieve a desired increase in lung pressure.

31. The method as in claim 1, wherein the step of ventilating the patient through the catheter comprises delivering gas at a flow rate of up to 10 lpm.

41. The method as in claim 1, further comprising the step of assisting in removal of CO₂ gas from the patient.

42. The method as in claim 41, wherein the step of assisting in gas removal comprises using a vacuum source to suction CO₂ gas from the patient through the catheter.

43. The method as in claim 41, wherein (i) the catheter comprises at least two lumens, (ii) the step of ventilating the patient through the catheter by delivering gas at a positive pressure and flow rate sufficient to increase lung pressure comprises delivering the gas through the first lumen, and (iii) and the step of assisting in gas removal comprises delivering gas through the second lumen at a positive pressure and rate sufficient to assist in the removal of CO₂-rich gas during an expiration phase of the patient.

2. An apparatus for ventilating a patient, the apparatus comprising:

a ventilation catheter with a distal and proximal end, wherein the distal end is configured to be anchored in the patient'"'"'s airway for extended use wherein the catheter does not occlude the airway, and wherein the proximal end is configured to be attached to an external ventilator, and comprising at least one lumen extending the length of the catheter, and

a wear-able ventilator, comprising a gas delivery supply and a gas removal source coupled to the at least one lumen at the proximal end of the ventilation catheter, wherein the ventilator is configured to supply gas at a positive pressure and volumetric flow rate sufficient to increase lung pressure.

32. The device as in claim 2, wherein the wear-able ventilator is configured to supply gas at a gas flow rate of up to 10 lpm.

44. The apparatus as in claim 2 wherein the ventilation catheter is a percutaneous transtracheal catheter.

45. The apparatus as in claim 2 wherein the ventilation catheter passes through the nasal airway.

46. The apparatus as in claim 2 wherein the ventilation catheter further comprises a connector adapted to connect to a tracheal tube.

47. The apparatus as in claim 2 wherein the at least one lumen of the ventilation catheter comprises at least two lumens, wherein a first lumen is in communication with the gas removal source and a second lumen is in communication with the gas delivery supply.

48. The apparatus as in claim 2 wherein the ventilation catheter further comprises a connector external to the patient adapted to removably attach a portion of the catheter wholly external to the patient to a portion of the catheter partly internal to the patient.

49. The apparatus as in claim 2 wherein the ventilation catheter further comprises a sealing and tensioning connector adapted to seal and secure the catheter to a percutaneous access site.

50. The apparatus as in claim 2 wherein the ventilation catheter further comprises a sealing and tensioning connector adapted to seal and secure the catheter to a tracheal tube.

51. The apparatus as in claim 2 wherein the ventilation catheter has a length of 25-300 cm, an outer diameter of 1 to 5 mm, and a ventilation gas delivery lumen effective diameter of 0.1 to 3.0 mm.

52. The apparatus as in claim 47 wherein the effective diameter of the second lumen is 0.1 to 3.0 mm and the effective diameter of the first lumen is 0.3 to 1.0 mm.

53. The apparatus as in claim 2 wherein the ventilation catheter comprises an extruded thermoplastic or thermoset material of 30-70 Shore A durometer.

54. The apparatus as in claim 2 wherein the ventilation catheter comprises a therapeutic compound selected from the group consisting of an antibiotic coating, antimicrobial coating, and an antifungal coating.

55. The apparatus as in claim 2 wherein the ventilation catheter comprises a radiopaque constituent or radiopaque marking.

56. The apparatus as in claim 2 wherein the ventilation catheter comprises at least one section having circumferential ridges adapted to lengthen or shorten the catheter length and to absorb forces.

59. The apparatus as in claim 2 wherein the ventilator further comprises a ventilation gas control unit in communication with a ventilation gas supply, wherein the ventilation gas control unit comprises pressure and flow measuring and regulating devices, and wherein the ventilation gas control unit is adapted to produce and regulate a desired pressure and flow output of the ventilator and a desired airway pressure.

60. The apparatus as in claim 59 wherein the desired airway pressure measured in the trachea is 5-30 cm H₂O.

61. The apparatus as in claim 59 wherein the ventilation gas control unit communicates with a vacuum source, and wherein the ventilation gas control unit further comprises at least one vacuum measuring and regulating device, and the ventilation gas control unit is further adapted to produce and regulate a desired vacuum level output of the ventilator and a desired airway pressure or gas composition.

62. The apparatus as in claim 2 wherein the ventilator further comprises an airway pressure measuring device, wherein airway pressure measurements are used to adjust the output of the ventilator.

63. The apparatus as in claim 2 wherein the ventilator further comprises an airway CO₂ measuring device wherein airway CO₂ is used to adjust the output of the ventilator.

64. The apparatus as in claim 2 wherein the ventilator further comprises a user interface, wherein the user interface is adapted to allow selection and display of desired ventilation parameters, and display of monitored ventilation parameters.

65. The apparatus as in claim 2 wherein the ventilator is a module of a mechanical ventilator.

66. The apparatus as in claim 2 wherein the gas delivery supply comprises an internal pressurized gas source, the gas removal source comprises an internal vacuum source, and the ventilator further comprises an internal battery and a fastener selected from the group consisting of a belt clip, a shoulder strap, and a pack.

67. The apparatus as in claim 2 wherein the ventilator further comprises an integral removable and replaceable ventilation gas supply container.

68. The apparatus as in claim 2 wherein the ventilator further comprises an integral refillable ventilation gas supply container.

69. The apparatus as in claim 2 wherein the ventilator is adapted to produce a tracheal airway pressure of 5-30 cm H₂O.

70. The apparatus as in claim 2 wherein the ventilator is adapted to produce a lobar segmental bronchus airway pressure of 3-20 cm H₂O.

71. The apparatus as in claim 2 wherein the ventilator is adapted to produce an airway pressure at the lung lobar segmental level of 3-20 cm H₂O.

72. The apparatus as in claim 2 wherein the catheter is adapted so the distal tip may be placed in the tracheal airway.

73. The apparatus as in claim 2 wherein the catheter is adapted to be placed through the nasal airway.

74. The apparatus as in claim 2 wherein the catheter is adapted so the distal tip may be placed in a main stem bronchus airway.

75. The apparatus as in claim 2 wherein the catheter is adapted so the distal tip may be placed in a lobar bronchus airway.

76. The apparatus as in claim 2 wherein the catheter is adapted so the distal tip may be placed in a segmental bronchus airway.

3. A method for directly ventilating a subject, comprising:

placing a continuously indwelling catheter in a subject'"'"'s bronchial tree beyond the lobar bronchus, wherein the catheter has a distal end and a proximal end, wherein the distal end is adapted to be anchored in the bronchus of the lung compartment, and wherein the catheter is adapted to remain in place for extended periods without clinician vigilance;

connecting the proximal end of the catheter to a wear-able ventilation source external to the patient, and wherein the ventilation source includes a gas removal source and a gas delivery supply, and wherein the catheter is configured to provide gas delivery and gas removal through the catheter; and

ventilating the patient through the catheter by delivering gas at a positive pressure and rate sufficient to increase lung pressure.

4. A method for directly ventilating a patient using a wear-able ventilator, via an indwelling catheter placed in the patient'"'"'s airway, the method comprising:

anchoring a distal end of the catheter within the patient'"'"'s airway so that the catheter can remain in place for extended periods without vigilance;

connecting a proximal end of the catheter to a wear-able ventilator external to the patient, wherein the ventilator includes gas removal source and a gas delivery supply; and

ventilating the patient through the catheter by delivering gas at a positive pressure and flow rate sufficient to increase lung pressure.

5. The method as in claim 4 wherein the step of ventilating comprises providing gas delivery and gas removal.

6. The method as in claim 5 wherein the gas delivery comprises applying pressure, wherein the pressure level is applied synchronous with the patient'"'"'s breathing.

7. The method as in claim 4 wherein the step of ventilating comprises providing a gas delivery phase and a gas removal phase that alternate.

8. The method as in claim 4 wherein the step of ventilating comprises providing a gas delivery phase and a gas removal phase that alternate at a rate of one to sixty cycles per minute.

9. The method as in claim 4 wherein the step of ventilating comprises providing a gas delivery phase and a gas removal phase that are synchronized with a breath cycle.

10. The method as in claim 4 wherein the step of ventilating comprises providing a gas delivery phase and a gas removal phase that occur simultaneously.

11. The method as in claim 5 wherein parameters of the gas delivery and gas removal are controlled so that a residual volume in the lung area decreases.

12. The method as in claim 5 wherein the gas delivery comprises delivery of a ventilation gas and wherein the parameters of the gas delivery are regulated to obtain a predominant concentration of the ventilation gas in the target area.

13. The method as in claim 5 wherein the gas delivery comprises delivery of a ventilation gas to create an elevated pressure in a lung area for the purpose of facilitating displacement of stagnant native gas, mixed gases and waste gases from the area.

14. The method as in claim 5 wherein the step of ventilating comprises providing a pressure in a targeted area of the lung compartment by measuring pressure and adjusting the gas delivery and or the gas removal to achieve a desired pressure.

15. The method as in claim 5 wherein the step of ventilating comprises measuring a gas concentration in an area to determine completeness of native gas displacement from the area by the gas delivery and gas removal, or to determine and adjust parameters of the gas delivery and gas removal to optimize therapy.

16. The method as in claim 5 wherein the gas delivery and removal comprises positive pressure gas delivery, wherein the lung pressure is in the range of 3-20 cmH₂O and 8-40 cmH₂O during natural breathing and mechanical ventilation, respectively.

17. The method as in claim 5 wherein the gas delivery and removal comprises alternating positive pressure gas delivery to collapse bronchii feeding an area to trap delivered gas in the area.

18. The method as in claim 4 wherein the step of ventilating comprises providing gas flow rates of up to 10 lpm.

19. The method as in claim 4 wherein the airway feeding a targeted lung area remains patent during ventilation and is not occluded with the catheter.

20. The method as in claim 4 wherein the step of ventilating comprises providing passive gas exhaust from the area around the outside of the catheter.

21. The method as in claim 5 wherein the gas delivery is a therapeutic gas which is therapeutic to respiratory function selected from the group consisting of:

1000% O₂, Helium, HeliOx, Nitric Oxide, and combinations thereof.

22. The method as in claim 5 further comprising delivering a liquid that is therapeutic to the mechanics of respiration selected from the group consisting of:

Perfluorocarbon, surfactant, mucolytic, and combinations thereof.

23. The method as in claim 5 further comprising delivering a therapeutic substance to improve pulmonary function, selected from the group consisting of:

mucolytic agents, surfactants, beta-agonists, anti-inflammatories, steroids, antibiotics, vitamin derivatives, vasodilators, viral vector agents, mono-clonal antibodies, chemotherapeutics, radioactive isotopes, stem cells, and combinations thereof.

24. The method as in claim 4 wherein the step of ventilating the patient is performed concurrent with positive pressure ventilation from a mechanical ventilator, wherein the catheter is inserted into the patient'"'"'s tracheobronchial tree through an artificial airway.

25. The method as in claim 4 wherein the step of ventilating the patient is performed on a naturally breathing patient, wherein the catheter is adapted to be inserted into the patient'"'"'s tracheobronchial tree through a natural airway.

26. The method as in claim 4 further comprising ventilating different lung areas simultaneously or sequentially, wherein the lung areas include a bronchopulmonary compartment of the lung.

27. The method as in claim 4 wherein the procedure is adapted to be performed acutely for a period of 1-24 hours.

28. The method as in claim 4 further comprising guiding the catheter to a targeted lung area with a guiding member selected from the group consisting of:

an endoscope, a fluoroscope, a guidewire or guiding catheter, an obturator, and combinations thereof.

29. The method as in claim 4 further comprising the step of pausing the step of ventilating and removing the catheter, wherein a guidewire is left in place to facilitate re-insertion of the catheter, and further comprising the steps of reinserting the catheter and resuming the ventilation.

33. The method as in claim 4, wherein the step of anchoring the distal end of the catheter within the patient'"'"'s airway comprises anchoring the distal end of the catheter within the subject'"'"'s bronchial tree.

34. The method as in claim 4, wherein the flow rate is set at a rate sufficient to achieve a desired volume output, wherein the desired volume output is sufficient to achieve a desired increase in lung pressure.

35. The method as in claim 5, wherein the gas delivery comprises applying pressure wherein the pressure level is continuous.

36. The method as in claim 5, wherein the gas delivery comprises applying pressure wherein the pressure level is oscillatory.

37. The method as in claim 5, wherein the gas delivery and removal comprises positive pressure gas delivery, wherein the tracheal pressure is in the range of 5-30 cmH₂O and 10-50 cmH₂O during natural breathing and mechanical ventilation, respectively.

77. The method as in claim 4 wherein the step of ventilating the patient is performed on a naturally breathing patient, wherein the catheter is adapted to be inserted into the patient'"'"'s tracheobronchial tree through an unnatural channel selected from the group consisting of:

a cricothyrotomy, a tracheotomy, or combinations thereof.

78. The method as in claim 4 wherein the gas is delivered at a positive pressure and flow rate sufficient to produce a tracheal airway pressure in the range of 5-30 cm H₂O.

79. The method as in claim 4 wherein the gas is delivered at a positive pressure and flow rate sufficient to produce a lobar segmental bronchus airway pressure in the range of 3-20 cm H₂O.

80. The method as in claim 4 further comprising placing a distal tip of the catheter in the trachea.

81. The method as in claim 4 further comprising placing a distal tip of the catheter distal to the carina.

82. The method as in claim 4 further comprising placing a distal tip of the catheter in the lobar bronchus.

83. The method as in claim 4 further comprising placing a distal tip of the catheter distal to the lobar bronchus.

84. The method as in claim 4 wherein the catheter is connected to a tracheal tube.

85. The method as in claim 25 wherein the natural airway is the nasal airway.

38. An apparatus for ventilating a patient, the apparatus comprising:

a percutaneous transtracheal ventilation catheter configured to be placed in an airway of the patient, wherein the catheter is configured to be anchored to allow extended use without vigilance and so that the patient'"'"'s airway is patent to allow spontaneous breathing around the catheter;

a ventilator external to the patient, wherein the ventilator is a wear-able ventilator, and wherein the ventilator is configured to ventilate the patient through the catheter by delivering gas at a positive pressure and flow rate sufficient to increase lung pressure.

39. The apparatus as in claim 38, wherein the apparatus further comprises a vacuum source configured to suction CO₂ gas from the patient through the catheter.

40. The apparatus as in claim 38, wherein (i) the catheter comprises at least two lumens, (ii) the ventilator is configured to ventilate the patient through the catheter by delivering gas at a positive pressure and flow rate sufficient to increase lung pressure through the first lumen during an inspiration phase of the patient, and (iii) the ventilator is further configured to deliver gas through the second lumen to assist in the removal of CO₂-rich gas during an expiration phase of the patient.

57. An apparatus for ventilating a patient, the apparatus comprising:

a ventilation catheter with a distal and proximal end, wherein the distal end is configured to be anchored in the patient'"'"'s airway for extended use, wherein the catheter does not occlude the airway, and wherein the proximal end is configured to be attached to an external ventilator, and comprising at least one lumen extending the length of the catheter, and

a wear-able ventilator, comprising a gas delivery supply coupled to the at least one lumen at the proximal end of the ventilation catheter, wherein the ventilator is configured to supply gas at a positive pressure and volumetric flow rate sufficient to increase lung pressure during an inspiration phase of the patient and wherein the ventilator is configured to deliver gas through the second lumen to assist in the removal of CO₂-rich gas during an expiration phase of the patient.

58. The apparatus as in claim 57,

wherein the at least one lumen of the ventilation catheter comprises at least two lumens,

wherein a first lumen is adapted for gas delivery and comprises a first gas delivery port at the distal end of the catheter, wherein the first gas delivery port is oriented and adapted to direct gas being delivered by the first lumen toward the lung,

wherein a second lumen is adapted for gas delivery and comprises a second gas port near the distal end of the catheter, wherein the second gas port is oriented and adapted to direct gas being delivered by the second lumen away from the lung,

wherein the ventilator is adapted to deliver ventilation gas through the first lumen during inspiration,

and wherein the ventilator is adapted to deliver gas through the second lumen during expiration.

86. A method for directly ventilating a patient via an indwelling catheter placed in the-patient'"'"'s airway and using a wear-able ventilator, the method comprising:

anchoring a distal end of the catheter within the patient'"'"'s airway so that the catheter can remain in place for extended periods without vigilance;

connecting a proximal end of the catheter to a wear-able ventilator external to the patient, wherein the ventilator includes a gas delivery supply; and

ventilating the patient through the catheter by (i) delivering gas at a positive pressure and rate sufficient to increase lung pressure during an inspiration phase of the patient and (ii) delivering gas at a positive pressure and rate sufficient to assist in the removal of CO₂-rich gas during an expiration phase of the patient.

87. The method as in claim 86,

wherein the catheter comprises at least two lumens;

wherein a first lumen is adapted for gas delivery and comprises a first gas delivery port at the distal end of the catheter, wherein the first gas delivery port is oriented and adapted to direct gas being delivered by the first lumen toward the lung;

wherein a second lumen is adapted for gas delivery and comprises a second gas port near the distal end of the catheter, wherein the second gas port is oriented and adapted to direct gas being delivered by the second lumen away from the lung;

wherein the ventilator is adapted to deliver ventilation gas through the first lumen during the inspiration phase of the patient;

and wherein the ventilator is adapted to deliver gas through the second lumen during the expiration phase of the patient.