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

• US 8,955,518 B2
• Filed: 02/03/2012
• Issued: 02/17/2015
• 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 D.
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US13/365,917
• Publication Number:
  US 20130019864A1
• Time in Patent Office: 1,110 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 redirecting inspired air to other healthier lung areas. 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. Typically the catheter'"'"'s distal tip is anchored without occluding the bronchus. TTSV is optionally performed by insufflation only of the area, or by the 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. An apparatus for the purpose of directly ventilating a lung area of a patient, the apparatus 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;

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

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

b. a ventilation gas control unit comprising;

i. a ventilation gas supply, and comprising an output connection means for connection of said proximal end of said catheter and comprising a coupling means to couple said ventilation gas supply with a fluid lumen of said catheter, and comprising a ventilation measurement and regulation means to produce and regulate a desired output of said ventilation gas supply;

a vacuum supply, and comprising a connection means for connection of said proximal end of said catheter and comprising a coupling means to couple said vacuum supply with said fluid lumen of said catheter, and further comprising a vacuum measurement and regulation means to produce and regulate a desired output of said vacuum supply;

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

iv. a gas concentration measuring means.

2. An apparatus as in claim 1 wherein said anchoring means is a non-occlusive member.

3. An apparatus as in claim 1 wherein said catheter further comprises an outer sleeve axially slidable about said shaft of said catheter, and wherein said anchoring means is compressed between said shaft and said outer sleeve, and wherein axial retraction of said outer sleeve releases said anchor anchoring means to expand.

4. An apparatus as in claim 1 wherein said anchoring means comprises a clip member, said clip configured for attachment to a bronchial bifurcation or septum.

5. An apparatus as in claim 1 wherein said anchoring means comprises an occlusive member.

6. An apparatus as in claim 1 wherein said distal end of said catheter includes an occlusive member to occlude a bronchus and a non-occlusive anchor to anchor said catheter in a bronchus.

7. An apparatus as claim 1 wherein said catheter comprises a lumen in which a guiding member is placed, and wherein said guiding member includes said anchoring means at its distal end wherein said anchoring means protrudes from the distal tip of said catheter.

8. An apparatus as in claim 1 wherein said catheter further comprises at least two lumens, one for gas delivery and one for gas removal by vacuum.

9. An apparatus as in claim 1 wherein said securing means is configured to seal and secure said catheter to a percutaneous access site.

10. An apparatus as in claim 1 wherein at least the distal end of said catheter comprises a plurality of branches wherein said branches are configured for cannulating multiple bronchi simultaneously.

11. An apparatus as in claim 1 wherein at least one said catheter is movably slidable in at least one lumen in a tracheal tube.

12. An apparatus as in claim 1 wherein a length of said catheter is 25 to 300 cm.

13. An apparatus as in claim 1 wherein said catheter futher comprises an extruded thermoplastic or thermoset tubular material construction.

14. An apparatus as in claim 1 comprising a port near said distal end of said catheter, said port directed proximally away from targeted lung area, wherein said port communicates with a lumen in said catheter, said lumen connected to a pressurized gas source, and wherein said ventilation gas control unit delivers a pressurized gas to said lumen thus entraining gas in said targeted area to be exhausted proximally with said pressurized gas.

15. An apparatus as in claim 1 integral to or re-movably attachable to a mechanical ventilator.

16. An apparatus as in claim 1 comprising features for portability and wearability by the user selected from the group consisting of an internal battery, an internal pressurized gas source, an internal vacuum source, a belt clip, a fanny pack and a shoulder strap.

17. An apparatus as in claim 1 comprising a replaceable or refillable ventilation gas cartridge.

18. An apparatus as in claim 1 wherein the gas concentration measuring means is configured to measure CO₂ concentration of gas removed from the lung area of the patient.

19. An apparatus as in claim 1 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.

20. A system for site-specific ventilation of an area of a lung of a patient, comprising:

an indwelling catheter adapted to be disposed in a bronchus of a poorly ventilated lung area to provide direct ventilation to that area, the indwelling catheter including at least one lumen, a distal end and a proximal end;

an anchor disposed on the distal end of the catheter, the anchor being adapted to dilate a bronchus to secure the indwelling catheter in position for an extended time;

a gas control unit coupled to the catheter to control flow through the lumen of the catheter;

a gas delivery system coupled to the catheter and the gas control unit, the gas delivery system being adapted to provide ventilation gas through the lumen of the catheter to the area of the lung;

a gas removal vacuum system coupled to the catheter and the gas control unit, the gas removal system being adapted to suction CO₂ rich stagnant gas from the area of the lung through the lumen of the catheter,

wherein the gas control unit is adapted to control the gas removal and delivery systems to deliver and suction gas through the catheter to and from the area of the lung without total lung mechanical ventilation and without collapsing the area of the lung; and

a patient respiration sensor coupled to the gas control unit to synchronize the gas delivery system and the gas removal system to a patient'"'"'s spontaneous inspiratory phase and expiratory phase.

21. An apparatus for the purpose of directly ventilating a lung area of a patient, the apparatus 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;

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

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

iv. an outer sleeve axially slidable about said shaft, wherein said anchoring means is compressed between said shaft and said outer sleeve, and wherein axial retraction of said outer sleeve releases said anchoring means to expand;

b. a ventilation gas control unit comprising;

i. a ventilation gas supply, and comprising an output connection means for connection of said proximal end of said catheter and comprising a coupling means to couple said ventilation gas supply with a fluid lumen of said catheter, and comprising a ventilation measurement and regulation means to produce and regulate a desired output of said ventilation gas supply;

ii. a vacuum supply, and comprising a connection means for connection of said proximal end of said catheter and comprising a coupling means to couple said vacuum supply with said fluid lumen of said catheter, and further comprising a vacuum measurement and regulation means to produce and regulate a desired output of said vacuum supply;

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

22. An apparatus for the purpose of directly ventilating a lung area of a patient, the apparatus 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 occlusive member to occlude a bronchus and a non-occlusive anchor to anchor said catheter in a bronchus;

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

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

b. a ventilation gas control unit comprising;

i. a ventilation gas supply, and comprising an output connection means for connection of said proximal end of said catheter and comprising a coupling means to couple said ventilation gas supply with a fluid lumen of said catheter, and comprising a ventilation measurement and regulation means to produce and regulate a desired output of said ventilation gas supply;

ii. a vacuum supply, and comprising a connection means for connection of said proximal end of said catheter and comprising a coupling means to couple said vacuum supply with said fluid lumen of said catheter, and further comprising a vacuum measurement and regulation means to produce and regulate a desired output of said vacuum supply;

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