Methods and devices for sensing respiration and providing ventilation therapy

• US 10,058,668 B2
• Filed: 03/20/2014
• Issued: 08/28/2018
• Est. Priority Date: 05/18/2007
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Wondka, Anthony, Kapust, Gregory, Bryan, Robert, Khenansho, Michael
• Primary Examiner(s): Ho, Jackie Tan-Uyen T
• Assistant Examiner(s): Boecker, Joseph D
• Application Number:
  US14/221,210
• Publication Number:
  US 20140288456A1
• Time in Patent Office: 1,622 Days
• Field of Search: 12820423, 12820714, 128DIG 26, 600532, 600533, 600537, 600538, 600120-125
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/0873 using optical means
• CPC Class Codes: A61B 5/0878 using temperature sensing means
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket
• CPC Class Codes: A61M 16/0003 Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 16/042 with separate conduits for in-and expiration gas, e.g. for limited dead volume
• CPC Class Codes: A61M 16/0427 with removable and re-insertable liner tubes, e.g. for cleaning
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 16/0465 Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
• CPC Class Codes: A61M 16/0475 having openings in the tube
• CPC Class Codes: A61M 16/0486 Multi-lumen tracheal tubes
• 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 2016/003 with a flowmeter
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/102 Measuring a parameter of the content of the delivered gas
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/332 : Force measuring means
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2230/43 : Composition of exhalation
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity

Abstract

Methods and systems are provided for intra-airway breath sensors where intra-airway breath sensors are not located within a ventilation gas delivery circuit, but are exposed to spontaneous respiration airflow from a patient. Furthermore, methods and systems of the present invention may be used to protect an intra-airway breath sensor from contacting tissue or accumulating debris that may impair abilities of the intra-airway breath sensors.

Claims

1. A breath sensing and ventilation delivery apparatus comprising:

a ventilation catheter,

a tracheostomy tube cannula with one or more fenestrations in a wall thereof, wherein the cannula at least partially surrounds the ventilation catheter to create an annular space between an inner diameter of the cannula and an outer diameter of the ventilation catheter, and

one or more adjustable depth intra-airway breath sensors structurally independent of the ventilation catheter and the tracheostomy tube cannula, and being positionable within the annular space between the inner diameter of the cannula and the outer diameter of the ventilation catheter and within a path of spontaneous patient respiration airflow passing through the one or more fenestrations.

2. The apparatus of claim 1, wherein the ventilation catheter extends beyond a distal portion of the cannula and into an airway.

3. The apparatus of claim 1, further comprising an anchor for preventing movement of a distal tip of the ventilation catheter.

4. The apparatus of claim 1, wherein the one or more fenestrations are located in a position selected from the group consisting of a superior side of the cannula, an inferior side of the cannula, a lateral side of the cannula, and combinations thereof.

5. The apparatus of claim 1, wherein the one or more intra-airway breath sensors are selected from the group consisting of thermal sensors, pressure sensors, pressure sensing lumen, tubes with sensing lumen, sensing subassemblies, gas composition sensors, flow sensors, ultrasonic sensors, resistivity sensors, piezoelectric sensors, light emittance/reflectance sensors, and combinations thereof.

6. The apparatus of claim 1, wherein the one or more intra-airway breath sensors are coupled to the ventilation catheter.

7. The apparatus of claim 1, wherein the ventilation catheter is removable from the cannula.

8. The apparatus of claim 1, further comprising a seal between the cannula and the ventilation catheter at a location proximal to the one or more intra-airway breath sensors.

9. A breath sensing and ventilation delivery apparatus comprising:

(a) a tubular member with a proximal end and a distal end, wherein the proximal end is adapted to be positioned outside a patient and the distal end is adapted to be positioned in an airway of the patient, wherein the tubular member includes one or more fenestrations in a wall thereof, wherein spontaneous respiration by the patient passes through the one or more fenestrations,

(b) one or more adjustable depth intra-airway breath sensors structurally independent of the tubular member and within a lumen of the tubular member,

wherein a distal end portion of the tubular member is positioned in the airway such that the one or more adjustable depth intra-airway breath sensors are located within the airway, and

wherein the one or more adjustable depth intra-airway breath sensors are positioned within a path of the spontaneous respiration by the patient passing through the one or more fenestrations while within the airway.

10. The apparatus of claim 9, wherein the one or more fenestrations are located in a position selected from the group consisting of a superior side of the tubular member, an inferior side of the tubular member, a lateral side of the tubular member, and combinations thereof.

11. The apparatus of claim 9, wherein the one or more intra-airway breath sensors are selected from the group consisting of thermal sensors, pressure sensors, pressure sensing lumen, tubes with sensing lumen, sensing subassemblies, gas composition sensors, flow sensors, ultrasonic sensors, resistivity sensors, piezoelectric sensors, light emittance/reflectance sensors, and combinations thereof.

12. A method for breath sensing and ventilation comprising:

inserting at least one adjustable depth intra-airway breath sensor into a tubular guide positioned with a proximal end adapted to be outside of a patient and a distal end adapted to be inside an airway of the patient, the at least one intra-airway breath sensor being structurally independent of the tubular guide and being positionable within the tubular guide within a path of airflow from spontaneous patient respiration; and

monitoring the patient'"'"'s airway airflow with the at least one intra-airway breath sensor during ventilation,

wherein, during said monitoring, the at least one adjustable depth intra-airway breath sensor is not located within a ventilator gas flow, and

wherein, during said monitoring, the at least one adjustable depth intra-airway breath sensor is shielded from contacting tissue and from accumulating debris by the tubular guide.

13. The method of claim 12, wherein the tubular guide is a tracheostomy tube cannula.

14. The method of claim 13, wherein the cannula at least partially surrounds a ventilation catheter for providing the ventilator gas flow, wherein the cannula forms an annular space between the cannula and the ventilation catheter.

15. The method of claim 14, wherein the at least one intra-airway breath sensor is within the annular space.

16. The method of claim 13, wherein the cannula has one or more fenestrations.

17. The method of claim 12, wherein the tubular guide is a protective shield.

18. The method of claim 17, wherein the protective shield is selected from the group consisting of a shield tapered on at least one end, a shield collapsible against an outer surface of a ventilation catheter, stoma sleeve, and combinations thereof.

19. The method of claim 12, wherein the at least one intra-airway breath sensor is selected from the group consisting of thermal sensors, pressure sensors, pressure sensing lumen, gas composition sensors, flow sensors, ultrasonic sensors, resistivity sensors, piezoelectric sensors, light emittance/reflectance sensors, and combinations thereof.