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

• US 20050005936A1
• Filed: 06/17/2004
• Published: 01/13/2005
• 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
• Granted Patent: US 7,588,033 B2
• Time in Patent Office: Days
• US Class Current: 128/204.180
• 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, therapuetic 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 for directly ventilating a compartment of a lung via a continuously indwelling catheter placed in the bronchial tree, wherein said catheter has a distal end and a proximal end, wherein said distal end is anchored in the bronchus of said lung compartment, and wherein said proximal end is connected to an ventilation source external to the patient, and wherein said catheter can remain in place for extended periods without clinician vigilance and wherein said ventilation source includes a gas removal means and a gas delivery means and wherein said ventilating includes gas delivery and gas removal.

2. A method for directly ventilating a compartment of a lung via a continuously indwelling catheter placed in the bronchial tree, wherein said catheter has a distal end and a proximal end, wherein said distal end is anchored in the bronchus of said lung compartment, and wherein said proximal end is connected to an ventilation source external to the patient, and wherein said catheter can remain in place for extended periods without vigilance.

3. A method as in claim 2 wherein said ventilation comprises gas delivery and gas removal.

4. A method as in claim 2 wherein said ventilation comprises applying vacuum to said area wherein said vacuum level is continuous, intermittent, oscillatory at high, medium or low frequencies, synchronized with the patient'"'"'s breathing, or asynchronous with said patient'"'"'s breathing.

5. A method as in claim 2 wherein said ventilation comprises gas delivery wherein said delivery is continuous, intermittent, oscillatory at high, medium or low frequencies, synchronized with the patient'"'"'s breathing, or asynchronous with said patient'"'"'s breathing.

6. A method as in claim 2 wherein said ventilation comprises a gas delivery phase and a gas removal phase wherein said phases alternate.

7. A method as in claim 2 wherein said ventilation comprises a gas delivery phase and a gas removal phase wherein said phases alternate at a rate of one to sixty cycles per minute.

8. A method as in claim 2 wherein said ventilation comprises a gas delivery phase and a gas removal phase wherein said phases alternate and are synchronized with the breath cycle, such as but not limited to gas delivery during inspiration and gas removal during exhalation.

9. A method as in claim 2 wherein said ventilation comprises a gas delivery phase and a gas removal phase wherein said two phases occur simultaneously.

10. A method as in claim 2 wherein said ventilation comprises gas delivery and gas removal and wherein the parameters of said delivery and removal are controlled so that the residual volume in said lung area decreases, typically by removing more gas during said gas removal phase compared to gas delivered during said delivery phase.

11. A method as in claim 2 wherein said ventilation comprises the delivery of a ventilation gas and wherein the parameters of said ventilation are regulated to obtain a predominant concentration of said ventilation gas in said target area.

12. A method as in claim 2 wherein said ventilation comprises the delivery of a ventilation gas and wherein delivery is regulated to create an elevated pressure in said area for the purpose of facilitating displacement of stagnant native gas, mixed gases and waste gases from said area, such as displacement via the blood absorption, displacement through collateral channels, displacement proximally up the bronchial tree, or displacement through said catheter.

13. A method as in claim 2 wherein said ventilation comprises gas delivery and gas removal wherein the pressure in said targeted area is regulated by measuring said pressure and adjusting said gas delivery and or said gas removal to achieve a desired said pressure.

14. A method as in claim 2 wherein said ventilation comprises gas delivery and gas removal wherein a gas concentration in said area is measured to determine the completeness of native gas replacement from said area, or to determine and adjust the parameters of said ventilation to optimize the therapy, such as but not limited to measuring the CO₂ or O2 concentration of said removed gas.

15. A method as in claim 2 wherein said ventilation comprises positive pressure gas delivery and application of vacuum, wherein said pressure is typically in the range of 5-25 cmH2O and 20-50 cmH2O during natural breathing and mechanical ventilation respectively, and wherein said vacuum measured at said distal end of said catheter is typically in the range of −

3 to −

25 cmH2O.

16. A method as in claim 2 wherein said ventilation comprises alternating positive pressure gas delivery and application of vacuum, wherein the amplitude of said vacuum collapses the bronchii feeding said area to trap said delivered gas in said area and wherein said vacuum amplitude is typically in the range of −

15 to −

50 cmH2O.

17. A method as in claim 2 wherein said ventilation comprises fluid flow rates of 0.05 to 10 lpm.

18. A method as in claim 2 wherein said bronchus feeding said targeted lung area remains patent during said ventilation and is not occluded with said catheter.

19. A method as in claim 2 wherein said catheter comprises an occlusion means wherein said occlusion means occludes said bronchus feeding said targeted lung area during said ventilation and wherein said occlusion is continuous or intermittent and a desired intermittence.

20. A method as in claim 2 wherein said ventilation comprises passive gas exhaust from said area around the outside of said catheter.

21. A method as in claim 2 wherein said ventilation comprises gas delivery wherein said gas is a therapeutic gas, such as but not limited to 100% O2, Helium, HeliOx or Nitric Oxide.

22. A method as in claim 2 wherein said ventilation comprises fluid delivery wherein said fluid is a therapeutic fluid, such as but not limited to Perfluorocarbon, surfactant or mucolytic.

23. A method as in claim 2 wherein said ventilation comprises delivery of therapeutic substances, such as but not limited to mucolytic agents, surfactants, beta-agonists, anti-inflammatories, steroids, antibiotics, vitamin derivatives, vasodilators, viral vector agents, mono-clonal antibodies, chemotherapeutics, radioactive isotopes or stem cells.

24. A method as in claim 2 wherein said ventilation is performed on a patient concurrent with positive pressure ventilation from a mechanical ventilator, wherein the catheter is inserted into said patient'"'"'s tracheobronchial tree through an artificial airway, such as but not limited to a tracheal tube, oropharyngeal tube, a rigid bronchoscope or a breathing mask.

25. A method as in claim 2 wherein said ventilation is performed on a naturally breathing patient, wherein said catheter is inserted into said patient'"'"'s tracheobronchial tree through a natural channel or percutaneously through an unnatural channel such as a cricothyrotomy or tracheotomy.

26. A method as in claim 2 wherein the procedure is performed on different lung areas simultaneously or sequentially, or on the same lung area sequentially and wherein said lung areas include a bronchopulmonary compartment of the lung, such as but not limited to an entire lung, a lobe, a lobar segment, a lobar subsegment or a lobar sub-subsegment

27. A method as in claim 2 wherein the procedure is performed acutely for a period of 1-24 hours, subacutely for a period of 1-14 days, or chronically for more than 14 days.

28. A method as in claim 2 wherein said catheter is guided to the targeted lung area with a guiding means such as but not limited to an endoscopic means, a fluoroscopic means, a guidewire or guiding catheter means, or an obturator means.

29. A method as in claim 2 wherein said ventilation is paused by removal of said catheter and wherein a guidewire is left in place to facilitate re-insertion of said catheter, and wherein said ventilation is resumed by subsequent re-insertion of said catheter.

30. A method for directly aspirating an area of a lung via a continuously indwelling catheter placed in the bronchial tree, wherein said catheter has a distal end and a proximal end, wherein said distal end is anchored in the bronchus of said lung area, and wherein said proximal end is connected to an vacuum source external to the patient, and wherein said catheter can remain in place for extended periods without vigilance.

31. A method as in claim 31 wherein said aspiration comprises a positive pressure venturi gas jet at the distal end of said catheter wherein said jet is directed in the proximal direction away from targeted said lung area.

32. A method for blocking airflow into a compartment of a lung with an occlusion means, said occlusion means comprising a continuously indwelling catheter with an occlusion member at said catheter'"'"'s distal end, wherein the proximal end of said catheter remains external to the patient and wherein said catheter can remain in place for extended periods without vigilance.

33. A method as in claim 33 wherein said catheter includes a lumen and wherein a vacuum is delivered to said lung compartment via said lumen, wherein said vacuum is delivered continuously, intermittently or variably.

34. An apparatus and kit for the purpose of directly ventilating a lung area, comprising:

a. A catheter with a distal and proximal end with at least one lumen for fluid flow, comprising;

i. at its distal end an anchoring means to anchor said distal end of said catheter in a bronchial lumen for extend periods while the catheter is unattended by a clinician;

ii. comprising at its proximal end a connection means for connection to a ventilation control source external to the patient;

iii. comprising between said distal and proximal ends a securing means concentric with the shaft of said catheter for sealing, tensioning and connecting said catheter shaft to the entry point of said catheter into the body;

b. A ventilation Gas Control Unit comprising;

i. an integral compressed supply of ventilation gas, or an input connection to an external ventilation gas supply, and comprising an output connection means for connection of said catheter'"'"'s proximal end and comprising a coupling means to couple said gas with said catheter'"'"'s fluid lumen, and comprising pressure or flow measurement and regulation means, such as but not limited to amplitude regulating valves, on-off valves, pumps, switches and sensors, to produce and regulate a desired output of said ventilation gas;

ii. an integral vacuum supply means, or an input connection to an external vacuum supply, and comprising a connection means for connection of said catheter'"'"'s proximal end and comprising a coupling means to couple said vacuum with said catheter'"'"'s fluid lumen, and further comprising a pressure or flow measurement and regulation means such as but not limited to amplitude regulating valves, on-off valves, pumps, switches and sensors, to produce and regulate a desired output of said vacuum;

iii. a user interface for selection of the desired output and ventilation parameters and for displaying selected, measured and regulated input and output parameters;

35. An apparatus as in claim 34 wherein said catheter anchor is a non-occlusive member such as but not limited to an inflatable member or a radially compressible wire structure such as a thermoplastic or shape memory alloy wire.

36. A catheter as in claim 34 wherein said catheter comprises an outer sleeve axially slide-able about said catheter shaft and further wherein said anchor is compressed between said catheter shaft and sleeve, and wherein axial retraction of said sleeve releases said anchor to expand.

37. An apparatus as in claim 34 wherein said catheter anchor comprises a clip member, said clip configured for attachment to a bronchial bifurcation or septum.

38. An apparatus as in claim 34 wherein said catheter anchor comprises an occlusive member, such as but not limited to an inflatable or deflatable member.

39. An apparatus as in claim 34 wherein said catheter distal end includes an occlusive member to occlude a bronchus and a non-occlusive anchor to anchor said catheter in a bronchus.

40. An apparatus as claim 34 wherein the said catheter comprises a lumen in which a guiding member is placed, such as but not limited to a guidewire, guiding catheter or obturator, and wherein said guiding member includes said anchor at its distal end wherein said anchor protrudes from the distal tip of said catheter.

41. An apparatus as in claim 34 wherein the said catheter comprises at least two lumens, one for gas delivery and one for gas removal by vacuum.

42. A catheter as in claim 34 wherein said catheter comprises a connection means, said connection means positioned generally near the middle of said catheter'"'"'s length, and wherein said connection means comprises re-attachable detachment of the proximal section of said catheter which is external to the body.

43. A catheter as in claim 34 comprising a sealing and tensioning means concentric to and axially slide-able to said catheter'"'"'s shaft such as but not limited to a means to seal and secure said catheter to a percutaneous access site in the neck or to seal and secure said catheter shaft to an artificial airway such as a tracheal tube.

44. A catheter as in claim 34 wherein at least the distal end of said catheter comprises a plurality of branches wherein said branches are configured for cannulating multiple bronchi simultaneously.

45. An apparatus as in claim 34 wherein at least one said catheter is movably slide-able in at least one lumen in a tracheal tube.

46. A catheter as in claim 34 comprising a length of 25 to 300 cm, an other diameter of 1 to 5 mm, a ventilation gas delivery lumen effective diameter of 0.1 to 3 mm, optionally a vacuum gas removal lumen effective diameter of 0.5 to 3.0 mm, optionally a guiding member lumen effective diameter of 0.3 to 1.0 mm, an anchoring or occlusion member free state diameter of 4 to 25 mm.

47. A catheter as in claim 34 comprising an extruded thermoplastic or thermoset tubular material construction, optionally a filament structure within the wall of said tubular construction, said material comprising a durometer of 30-70 Shore A, said material optionally comprising a therapeutic compound such as but not limited to an antibiotic, antimicrobial or antifungal coating, and comprising a radiopaque constituent or optionally radiopaque markings.

48. A catheter as in claim 34 comprising at least one section comprising a means for length shortening or lengthening, such as but not limited to circumferential ridges, said section absorbing tension and compression imparted by external forces.

49. A catheter as in claim 34 comprising a port near said distal end said port directed proximally away from targeted lung area, and wherein said port communicates with a lumen in said catheter wherein said lumen is connected to a pressure source, and further wherein said Gas Control Unit delivers a pressurized gas to said lumen thus entraining gas in said targeted area to be exhausted proximally with said delivered gas.

50. A Gas Control Unit as in claim 34 integral to and or re-movably attachable to a mechanical ventilator.

51. A Gas Control Unit as in claim 34 comprising features for portability and wear-ability by the user, such as but not limited to an internal battery, an internal pressurized gas source, an internal vacuum source, and a belt clip, fanny pack or shoulder strap.

52. A Gas Control Unit as in claim 34 comprising a replaceable or refillable ventilation gas cartridge.

53. A Gas Control Unit as in claim 34 comprising or a pressure measuring means or a gas concentration measuring means, such as but not limited to the CO₂ concentration of gas removed from the treated area, to determine the completeness of native gas displacement from the treated area, or to determine and adjust the ventilation parameters as appropriate to optimize the therapy.

54. A apparatus as in claim 34 further comprising a kit, the kit comprising a ventilation catheter with sleeve connector, an access incision plug, a guiding catheter, a Gas Control Unit, a quantity of ventilation gas, a portable case, a spare battery and battery charger, cleaning supplies, a hygienic seal for sealing distal section of catheter when proximal section is removed, and an instruction sheet.