Endotracheal cuff and technique for using the same
View Patent ↗An inflatable balloon cuff may be adapted to seal a patient's trachea when associated with an endotracheal tube. Configurations of these cuffs that include tapered regions with certain characteristics, such as cuff wall diameter and thickness, may provide improved sealing of the trachea.
1. An inflatable balloon cuff comprising:
a tapered section running along at least 50% of a length of the inflatable balloon cuff comprising:
a sealing portion, wherein the sealing portion is adapted to form a wrinkle-free sealing band at least 1 millimeter in length against a patient's tracheal wall only when inflated;
a wrinkled portion, wherein a largest diameter of the wrinkled portion is larger than a tracheal diameter such that the wrinkled portion forms a wrinkled band against a patient's tracheal wall when inflated and wherein the wrinkled band is longer than the wrinkle-free sealing band; and
a minimal contact portion, wherein a largest diameter of the minimal contact region is less than the tracheal diameter.
2. The balloon cuff of claim 1 , wherein the tapered section comprises a substantially constant taper rate along the length of the tapered section.
3. The balloon cuff of claim 1 , wherein the wrinkle-free sealing band is between 1-3 millimeters in length.
4. The balloon cuff of claim 1 , wherein the wrinkle-free sealing band is between 3-6 millimeters in length.
5. The balloon cuff of claim 1 , wherein the balloon cuff comprises polyethylene teraphthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, polypropylene, or polyurethane (PU).
6. The balloon cuff of claim 1 , comprising a tracheal tube associated with the balloon cuff, wherein the tracheal tube passes through a proximal opening and a distal opening of the balloon cuff.
7. The balloon cuff of claim 6 , wherein the tracheal tube is operatively connected to a ventilator.
8. The balloon cuff of claim 6 , wherein the tracheal tube comprises a distal end adapted to be inserted into a patient's trachea and a proximal end, and wherein a tapered section tapers towards the distal end of the tracheal tube or the proximal end of the tracheal tube.
9. The balloon cuff of claim 6 , wherein the tapered section comprises a substantially nonlinear taper rate along at least a portion of the length of the tapered section.
10. The balloon cuff of claim 1 , comprising an antimicrobial coating on at least a portion of a balloon wall.
11. The balloon cuff of claim 1 , wherein narrowest portion of the tapered section has a balloon wall diameter that is less than 0.60 inches when the balloon cuff is fully inflated.
12. The balloon cuff of claim 1 , wherein the tapered section comprises balloon wall diameters between 1.75 inches and 0.15 inches when the balloon cuff is fully inflated.
13. The balloon cuff of claim 1 , wherein the tapered section comprises balloon wall thicknesses between 0.5 mils and 3 mils.
14. A method of manufacturing an inflatable balloon cuff comprising:
providing an inflatable balloon cuff having a tapered section comprising:
a sealing portion, wherein the sealing portion is adapted to form a wrinkle-free sealing band at least 1 millimeter in length against a patient's tracheal wall only when inflated;
a wrinkled portion, wherein a largest diameter of the wrinkled portion is larger than a tracheal diameter such that the wrinkled portion forms a wrinkled band against a patient's tracheal wall when inflated and wherein the wrinkled band is longer than the wrinkle-free sealing band; and
a minimal contact portion, wherein a largest diameter of the minimal contact region is less than a tracheal diameter.
15. A method of sealing a patient's trachea comprising:
inflating a balloon cuff comprising a tapered section in the patient's trachea,
wherein at least a portion of the balloon cuff is adapted to form a wrinkle-free sealing band against a patient's tracheal wall only when inflated, wherein the wrinkle-free sealing band is at least 1 millimeter in length;
wherein at least a portion of the balloon cuff is adapted to form a wrinkled portion, wherein a largest diameter of the wrinkled portion is larger than a tracheal diameter such that the wrinkled portion forms a wrinkled band against the patient's tracheal wall when inflated and wherein the wrinkled band is longer than the wrinkle-free sealing band; and
wherein at least a portion of the balloon cuff is adapted to form a minimal contact portion, wherein a largest diameter of the minimal contact region is less than a tracheal diameter.
16. An inflatable balloon cuff comprising:
a tapered section comprising at least a portion of the balloon cuff, wherein at least a portion of a balloon wall in the tapered section are less than 60 microns in thickness and wherein a thickness of the balloon wall is not constant along the tapered section regardless of whether the tapered section is inflated or deflated and wherein at least a portion of the tapered section is adapted to form a wrinkle-free sealing band at least 1 millimeter in length against a patient's tracheal wall only when inflated.
17. The balloon cuff of claim 15 , wherein the tapered section comprises a substantially constant taper rate along the length of the tapered section.
18. The balloon cuff of claim 15 , wherein the tapered section comprises at least 50% of the length of the cuff.
19. The balloon cuff of claim 15 , wherein the balloon cuff comprises polyethylene teraphthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU).
20. The balloon cuff of claim 15 , comprising a tracheal tube associated with the balloon cuff, wherein the tracheal tube passes through a proximal opening and a distal opening of the balloon cuff.
21. The balloon cuff of claim 20 , wherein the tracheal tube is operatively connected to a ventilator.
22. The balloon cuff of claim 20 , wherein the tracheal tube comprises a distal end adapted to be inserted into a patient's trachea and a proximal end, and wherein the tapered section tapers towards the distal end of the tracheal tube or the proximal end of the tracheal tube.
23. The balloon cuff of claim 16 , wherein the tapered section comprises a substantially nonlinear taper rate along at least a portion of the length of the tapered section.
24. The balloon cuff of claim 16 , comprising an antimicrobial coating on at least a portion of the balloon wall.
25. The balloon cuff of claim 16 , wherein narrowest portion of the tapered section has a balloon wall diameter that is less than 0.60 inches when the balloon cuff is fully inflated.
26. The balloon cuff of claim 16 , wherein the tapered section comprises balloon wall diameters between 1.75 inches and 0.15 inches when the balloon cuff is fully inflated.
27. A method of manufacturing an inflatable balloon cuff comprising:
providing an inflatable balloon cuff having a tapered section comprising at least a portion of the balloon cuff, wherein a balloon wall in at least a portion of the tapered section are less than 60 microns in thickness and wherein a thickness of the balloon wall is not constant along the tapered section regardless of whether the tapered section is inflated or deflated and wherein at least a portion of the tapered section is adapted to form a wrinkle-free sealing band at least 1 millimeter in length against a patient's tracheal wall only when inflated.
28. An inflatable balloon cuff comprising:
a proximal opening and a distal opening in a wall of the balloon cuff;
a first tapered section along an imaginary axis connecting the proximal opening and the distal opening of the inflated balloon cuff; and
a second tapered section along the imaginary axis connecting the proximal opening and the distal opening, wherein the second tapered section is disposed distally on the cuff relative to the first tapered section, wherein the first tapered section and the second tapered section taper away from one another, and wherein at least a portion of the first tapered section or the second tapered section is adapted to form a wrinkle-free sealing band at least 1 millimeter in length against a patient's tracheal wall only when inflated and wherein a widest diameter of the first tapered section and the second tapered section is greater than the tracheal diameter.
29. The balloon cuff of claim 28 , wherein the first tapered section or the second tapered section comprises a substantially constant taper rate along the length of the first or second tapered section.
30. The balloon cuff of claim 28 , wherein the balloon cuff comprises polyethylene teraphthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU).
31. The balloon cuff of claim 28 , comprising a tracheal tube coupled to the balloon cuff, wherein the tracheal tube passes through the proximal and distal openings in the wall of the balloon cuff.
32. The balloon cuff of claim 31 , wherein the tracheal tube is operatively connected to a ventilator.
33. The balloon cuff of claim 28 , comprising an antimicrobial coating on at least a portion of the balloon cuff.
34. The balloon cuff of claim 28 , wherein at least one tapered section comprises balloon wall diameters between 1.75 inches and 0.15 inches when the balloon cuff is fully inflated.
35. The balloon cuff of claim 28 , wherein the at least one tapered section comprises a substantially nonlinear taper rate along at least a portion of the length of the tapered section.
36. The balloon cuff of claim 28 , wherein the widest diameter portion of the first tapered section is proximate to the widest diameter portion of the second tapered section.
37. The balloon cuff of claim 28 , wherein a narrowest diameter portion of the first tapered section is proximate to a narrowest diameter portion of the second tapered section.
38. The inflatable balloon cuff of claim 1 , wherein the balloon cuff is adapted to be less than two times the diameter of an average adult trachea at its widest point when fully inflated outside the patient.
39. An inflatable balloon cuff comprising:
a tapered section, wherein at least a portion of the tapered section is adapted to form a wrinkle-free sealing band at least 1 millimeter in length against a patient's tracheal wall only when the balloon cuff is inflated within the trachea;
and wherein at least a portion of the tapered section is adapted to form a wrinkled band against the tracheal wall, wherein the wrinkled band is longer than the wrinkle-free sealing band, when the balloon cuff is inflated within the trachea.
40. The inflatable balloon cuff of claim 39 , wherein the wrinkled band comprising wrinkles is disposed distally on the cuff relative to the wrinkle-free sealing band.
41. The inflatable balloon cuff of claim 39 , wherein the wrinkled band comprising wrinkles is disposed proximally on the cuff relative to the wrinkle-free sealing band.
42. An inflatable balloon cuff comprising:
a tapered section comprising at least a portion of the balloon cuff, wherein a balloon wall in the tapered portion is greater than 20 microns but less than 60 microns in thickness, and wherein at least a portion of the tapered section is adapted to form a wrinkle-free sealing band at least 1 millimeter in length against a patient's tracheal wall only when inflated and wherein a widest diameter of the inflatable balloon cuff is proximal of a midpoint of the inflatable balloon cuff along an imaginary axis connecting a proximal opening and distal opening of the inflatable balloon cuff.
43. The inflatable balloon cuff of claim 39 , wherein a wall thickness at a largest diameter portion of the tapered section is less than a wall thickness at a smallest diameter portion of the tapered section.
44. The inflatable balloon cuff of claim 1 , wherein the largest diameter of the wrinkled portion is equal to or less than 1.5 times an average adult tracheal diameter.
45. An inflatable balloon cuff comprising:
a tapered section along at least 50% of the length along an imaginary axis of the inflated balloon cuff connecting a proximal opening and distal opening of the inflatable balloon cuff, the tapered section comprising:
a wrinkled portion, wherein a largest diameter of the wrinkled portion is larger than a tracheal diameter such that the wrinkled portion forms folds against a patient's tracheal wall when inflated;
a sealing portion, wherein the sealing portion is adapted to form a wrinkle-free sealing band at least 1 millimeter in length against a patient's tracheal wall only when inflated; and
a minimal contact portion, wherein a largest diameter of the minimal contact region is less than the tracheal diameter; and
a rounded portion, wherein the rounded portion extends to a proximal shoulder of the inflatable balloon cuff and wherein the rounded portion is proximal to the wrinkled portion and wherein the rounded portion comprises a largest diameter of less than 1.35 inches.
46. An inflatable balloon cuff comprising:
a tapered section along at least 50% of the length along an imaginary axis of the inflated balloon cuff connecting a proximal opening and distal opening of the inflatable balloon cuff, the tapered section comprising:
a wrinkled portion, wherein a largest diameter of the wrinkled portion is larger than a tracheal diameter such that the wrinkled portion forms folds against a patient's tracheal wall when inflated; and
a sealing portion, wherein the sealing portion is adapted to form a wrinkle-free sealing band at least 1 millimeter in length against a patient's tracheal wall only when inflated, and wherein the wrinkle-free sealing band is proximal of a midpoint of the imaginary axis; and
a minimal contact portion, wherein a largest diameter of the minimal contact region is less than the tracheal diameter.