IP Library Granted Patent US 10,369,312
Granted Patent B2
US 10,369,312 · App. 15/019,719 · Granted Aug 6, 2019

Low maintenance endotracheal tube device and method for preventing ventilator associated pneumonia and tracheal ischemia

Inventors: Steven L. Pendleton (Spencer, IN); Jeffrey D. Williams (Spencer, IN); Gary L. Neff (Bloomington, IN)
Assignee: Cook Medical Technologies LLC
A61M16/044A61M16/0438A61M16/0443A61M16/0456A61M16/0465A61M16/0481A61M2205/0222A61M2205/3331
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Quick Facts
Patent No.
US 10,369,312
App. No.
15/019,719
Granted
Aug 6, 2019
Kind
B2
Abstract

A method of sealing a trachea is provided that includes inserting a tracheal tube having an inflatable cuff made of a compliant material into a trachea. The method includes inflating the inflatable cuff with a fluid to a first pressure that exceeds a second pressure necessary to create a seal between the inflatable cuff and the tracheal wall. The method includes deflating the inflatable cuff by releasing a first pressure to allow the fluid to flow out of the inflatable cuff without applying vacuum pressure to the fluid while evaluating a rate of change of pressure of the fluid in the inflatable cuff. The method includes identifying a variance in the rate of change of pressure corresponding to a third pressure at which the inflatable cuff separates from the tracheal wall, determining the second pressure by analyzing the third pressure, and reinflating the inflatable cuff to the second pressure.

Claims (48)

1. A method of sealing a trachea, comprising:

inserting a tracheal tube comprising an inflatable cuff into a trachea comprising a tracheal wall, the inflatable cuff comprising a compliant material;

inflating the inflatable cuff with a fluid to a first pressure that exceeds a second pressure necessary to create a seal between the inflatable cuff and the tracheal wall;

deflating the inflatable cuff by releasing the first pressure to allow the fluid to flow out of the inflatable cuff without applying vacuum pressure to the fluid;

evaluating a rate of change of pressure of the fluid in the inflatable cuff while the inflatable cuff is deflating;

identifying a variance in the rate of change of pressure corresponding to a third pressure at which the inflatable cuff at least partially separates from the tracheal wall;

determining the second pressure by analyzing the third pressure; and

reinflating the inflatable cuff to the second pressure.

2. The method of claim 1 , wherein:

the second pressure is 0 to 50 centimeters of water more than the third pressure.

3. The method of claim 1 , wherein:

the fluid in the inflatable cuff comprises a liquid.

4. The method of claim 3 , wherein:

the fluid in the inflatable cuff further comprises a water soluble jelly.

5. The method of claim 1 , further comprising:

repeating the steps of inflating the inflatable cuff and deflating the inflatable cuff, wherein the third pressure is determined by analyzing a number of identified variances of rates of change of pressure during the plurality of deflating steps.

6. The method of claim 1 , wherein:

the compliant material of the inflatable cuff has a compliance of 20 to 500 percent.

7. The method of claim 1 , wherein the compliant material of the inflatable cuff has a porosity of 0.00001% to 0.5%.

8. The method of claim 1 , wherein:

the tracheal tube comprises an endotracheal tube.

9. The method of claim 1 , wherein:

the tracheal tube comprises a tracheostomy tube.

10. The method of claim 1 , wherein:

the pressure of the fluid in the inflatable cuff is measured using a manometer.

11. The method of claim 1 , wherein:

the steps of inflating and deflating the inflatable cuff further comprises using a syringe filled with the fluid to inflate and deflate the inflatable cuff.

12. The method of claim 1 , wherein:

the inflatable cuff is an outer cuff and the fluid is an outer cuff fluid, the tracheal tube further comprising an inner cuff, wherein the outer cuff surrounds the inner cuff; and

further comprising inflating the inner cuff with an inner cuff fluid after the step of inserting a tracheal tube;

wherein the step of evaluating a rate of change of pressure comprises measuring the rate of change of pressure of the inner cuff fluid while the outer inflatable cuff is deflating, the rate of change of pressure of the inner cuff fluid being responsive to the rate of change of pressure of the outer cuff fluid.

13. The method of claim 12 , wherein:

the step of inflating the inner cuff with an inner cuff fluid further comprises fully inflating the inner cuff and then deflating the inner cuff so that the inner cuff is partially inflated.

14. The method of claim 12 , wherein:

the inner cuff is comprised of a semi-compliant material, the semi-compliant material having a compliance of 5 to 30 percent.

15. The method of claim 12 , wherein:

the second pressure is 0 to 50 centimeters of water more than the third pressure.

16. The method of claim 12 , wherein:

the inner cuff fluid comprises a gas.

17. The method of claim 12 , wherein:

the outer cuff fluid comprises a liquid.

18. The method of claim 1 , wherein:

the second pressure is 0 to 50 centimeters of water more than the third pressure, the fluid in the inflatable cuff comprising a liquid, the compliant material having a compliance of 20 to 500 percent;

further comprising repeating the steps of inflating the inflatable cuff and deflating the inflatable cuff, wherein the third pressure is determined by analyzing a number of identified variances during the plurality of deflating steps;

wherein the steps of inflating and deflating the inflatable cuff comprises using a syringe filled with the fluid to inflate and deflate the inflatable cuff, the syringe having a plunger pressure less than the third pressure.

19. The method of claim 12 , wherein:

the step of inflating the inner cuff with an inner cuff fluid further comprises fully inflating the inner cuff and then deflating the inner cuff so that the inner cuff is partially inflated; and

the inner cuff is comprised of a semi-compliant material, the semi-compliant material having a compliance of 5 to 30 percent, the inner cuff fluid comprises a gas, the outer cuff fluid comprises a liquid, and the second pressure is 0 to 50 centimeters of water more than the third pressure.

Assignments (3)
SECURITY INTEREST Recorded Feb 28, 2024
From: COOK MEDICAL TECHNOLOGIES LLC
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 066700/0277 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 11, 2016
From: PENDLETON, STEVEN L.; WILLIAMS, JEFFREY D.; NEFF, GARY L.
To: COOK INCORPORATED
Reel/Frame 037703/0770 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 11, 2016
From: COOK INCORPORATED
To: COOK MEDICAL TECHNOLOGIES LLC
Reel/Frame 037704/0328 →
Continuity (2)
Provisional Application 62114369 · Feb 10, 2015
Related Publication 20160228662A1 · Aug 11, 2016