Inflatable nasal packing device with two non-elastic, flexible bags oversized relative to nasal cavities

• US 7,108,706 B2
• Filed: 05/28/2003
• Issued: 09/19/2006
• Est. Priority Date: 05/28/2003
• Status: Active Grant

• Current Assignee: Rose Biomedical Development Corporation
• Original Assignee: Rose Biomedical Development Corporation
• Inventors: Hogle, Gregory A.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Nguyen, Victor
• Application Number:
  US10/447,179
• Publication Number:
  US 20040243172A1
• Time in Patent Office: 1,210 Days
• Field of Search: 606/127, 606150-154, 606/196, 606/199, 604/94, 604/101, 604/286, 604/101.01, 604/101.02, 604/101.05, 604/358, 128/207.18
• US Class Current: 606/199
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers

Abstract

An inflatable nasal packing device, and method of use, for insertion in a patient'"'"'s nasal cavity to control bleeding or epistaxis. The device includes a flexible insertion tube, a first inflatable bag attached to and surrounding an anterior section of the tube, and a second inflatable bag attached to and surrounding a posterior section of the tube. The tube has three lumens for providing separate fill passageways to the two bags to allow independent filling and pressurization and for providing an air passageway through the device even when the bags are inflated. Both bags have walls of non-elastic, flexible material with fixed surface areas defining interior volumes when inflated that are larger than the anterior nasal cavity and the posterior nasal cavity and nasopharynx.

Claims

1. An inflatable apparatus for insertion into a nasal passage of a patient for controlling epistaxis, comprising:

an insertion tube having a first inlet for receiving gas or fluid from a first source and a first outlet for the gas or fluid received from the first source and a second inlet for receiving gas or fluid from a second source and a second outlet for the gas or fluid received from the second source;

a first bag including sealed sidewalls comprising non-elastic material sealably connected to the insertion tube with a fully-inflated interior volume defined by the bag sidewalls and in fluid communication with the first outlet, wherein the exterior of the first bag has a flat surface and the interior volume of the first bag defined by the sidewalls is greater than the volume of the anterior nasal cavity of the patient; and

a second bag including sealed sidewalls comprising non-elastic material sealably connected to the insertion tube with a fully-inflated interior volume defined by the bag sidewalls and in fluid communication with the second outlet, wherein said second bag partially overlaps with said first bag and the exterior of the second bag has a flat surface and the interior volume of the second bag defined by the sidewalls is greater than the volume of the posterior nasal cavity and nasopharynx of the patient.

2. The apparatus of claim 1, wherein the insertion tube comprises a lumen providing a passageway through the insertion tube.

3. The apparatus of claim 1, wherein the interior volume of the first bag defined by the sidewalls is greater than about 24 cubic centimeters and the interior volume of the second bag defined by the sidewalls is greater than about 10 cubic centimeters.

4. The apparatus of claim 1, wherein the first bag is connected to the insertion tube by a pair of seals at spaced apart first and second locations along the length of the insertion tube.

5. The apparatus of claim 4, wherein the second bag is connected to the insertion tube by a pair of seals at spaced apart third and fourth locations along the length of the insertion tube, the second and third locations being substantially adjacent.

6. The apparatus of claim 4, wherein the second bag is connected to the insertion tube by a pair of seals at spaced apart third and fourth locations along the length of the insertion tube, the third location being more proximate to the first location than the second location such that the first and second bags overlap for a length measured along a longitudinal axis of the insertion tube.

7. The apparatus of claim 6, the length being greater than about 0.25 inches.

8. The apparatus of claim 1, further including a layer of lubrication on an exterior surface of the sidewalls of the first and second bags.

9. The device of claim 8, further including a first pressurized fill source connected to the inlet to the first fill lumen and a second pressurized fill source connected to the inlet to the second fill lumen, wherein the first and second pressurized fill sources are independently operable.

10. The device of claim 9, wherein the first and second pressurized gas sources are operable to provide pressurized gas or fluid at a fill pressure to fill the first and second bags and at an inflation pressure higher than the fill pressure to pressurize the first and second bags to an epistaxis control pressure.

11. The device of claim 10, wherein the epistaxis control pressure is greater than about 60 millimeters Hg.

12. The apparatus of claim 1, wherein the non-elastic material of the sidewalls of the first and second bags is treated with ionization.

13. An inflatable nasal packing device, comprising:

an insertion tube comprising three lumen including an air passageway lumen extending the length of the tube with an opening at each end of the tube, a first fill lumen with an inlet at one end of the tube and an outlet in a first portion of the tube, and a second fill lumen with an inlet adjacent the inlet for the first fill lumen and an outlet in a second portion of the tube;

a first bag formed of non-elastic, flexible material positioned about the first portion of the tube and sealed to the tube with a pair of circumferential end seals that are spaced apart on the tube such that the first bag encloses a first portion of the tube; and

a second bag formed of non-elastic, flexible material positioned about the second portion of the tube and sealed to the tube with a pair of circumferential end seals that are spaced apart on the tube such that the second bag encloses a second portion of the tube wherein said first and second bag have flat outer surfaces that partially overlap one another.

14. The device of claim 13, wherein the first and second portions overlap for a length of the tube as measured along a longitudinal axis of the tube.

15. The device of claim 13, wherein the first bag comprises a first wall and a second wall that have a substantially fixed surface area, the first and second walls of the first bag defining an interior volume greater than about 16 cubic centimeters and further wherein the second bag comprises a first wall and a second wall that have a substantially fixed surface area, the first and second walls of the second bag defining an interior volume greater than about 10 cubic centimeters.

16. The device of claim 13, wherein the material of the first and second bags is polyurethane and wherein external surfaces of the first and second bags are lubricated.