|
How the Safe~Seal™ Works
Almost all ET tubes used today depend upon an
inflation cuff to seal the tube in the
trachea, except the
Safe-Seal™
ET tube
featuring the Blaine Bafflex System.
This new
technology uses
a series of 6 silicone baffles with
carefully engineered
pattern and
spacing to seal the trachea without pressure points.
The flexible baffles allow an “o-ring
effect”. The Safe-Seal ET
tube lies in the trachea and the sealing baffles touch the
tracheal
wall leaning towards the larynx. Thus, when the patient inspires the
silicone
baffles are sucked against the trachea forming
a tight seal.
The special design allows passage of pressure
exceeding 20-30 centimeters of water in
the patient’s lungs. If the
pop-off valve is accidentally left closed, the excess pressure is
released and no harm will come to the patient. If more than 20-30
centimeters of water
pressure is desired, the tube is merely
withdrawn ½ inch
causing the
baffles to
flip over
and the tip will then
face
caudally thereby allowing as much pressure to be applied as
deemed
necessary.
These soft, flexible baffles are atraumatic to
the tracheal surface due to the limited
contact of the baffles.
There is minimal contact with the tracheal wall when using the
Safe-Seal tube as opposed to the large area of contact of inflation
cuff tubes. This means
the tube can be left in the same position for
extended periods of time.
Another advantage
is the
“squeegee” effect when extubating, by scraping
the trachea
clean of any fluids present.
The Safe-Seal ET tube
with the Blaine Bafflex System
eliminates dangers of deflation or
over
inflation.
The standard tubes used today are constructed
of rigid, curved plastic. This shape and
rigidity forces the tip of
the tube against the tracheal wall when inflated, causing a point of
pressure. The Safe-Seal tube’s baffles keep the tip of the
tube centered in the trachea. It
is ultimately safer to use and can
cause no damage to the trachea.
Directions and Packaging
Insert:
Click on images for a
PDF, printable version:
Instructions:
FAQ:
Frequently Ask
Questions:
1. What makes this endotracheal tube better?
The Safe-Seal
tube was developed to eliminate the problems associated with
inflation
cuff tubes. No danger of leakage, over
pressurization, under inflation
or need for replacement
make this tube safer and cost effective. It cleanses
the
trachea upon extubation
and is atraumatic to the tracheal mucosa.
2. How long will it
last?
The Safe-Seal
tube has been used in clinical situations for over seven years
without failure or need
for replacement. The solid one-piece silicone design
will last for years.
3. Do I need to
worry about the tube kinking?
The soft, flexible nature
of the tube is an extreme advantage. Rotation of the
patient will not cause
harm to the trachea because the baffles rotate easily. As
with all tubes, a right
angle bending force could cause kinking. The operator
should be aware that the
tube should be securely attached to the snout and if
using a nonrebreather
apparatus, that it should be kept in front of the patient on
the table. Kinking has
not been a problem in the seven year clinical trials.
When using the smallest tube, the tip
of the tube is ¼ inch and is therefore
more flexible. The shaft of
the tube is 3/8 inch diameter and resistant to
kinking. As long as the flexible tip
is safely inside the trachea, it is not subjected
to bending forces.
4. What about
sterilization and cleaning?
The medical grade
silicone is autoclavable and resistant to cold disinfectants.
Gas sterilization is safe
but not necessary. The durable silicone can be
scrubbed in the usual fashion.
5. How many tubes do
I need?
Only 3 sizes of tubes are
necessary for a small animal practitioner for dogs
weighing 10 to 200
pounds. This makes the Safe-Seal Endotracheal tube
very
cost effective. It’s
durability gives this tube many years of use.
6. Will water or
fluids leak past the tube during procedures such as
dentals.
No. The tube is designed to seal
with 20-30 centimeters of water pressure in the
trachea. Unless positive
pressure exceeding this amount is applied in the
pharynx, no passage of
fluid is allowed to enter the lungs.
7. How does the tube
prevent over pressurization of the lungs of my patient?
The carefully spaced and
tapered baffles are designed to allow excess of
20-30 centimeters of
water to bypass and escape. Thus, if the
pop-off valve is
accidentally left closed, the pressure will be released and
no harm will come to the
patient.
8. What about “dead
air space’ in small, brachiocephalic breeds?
The tidal volume of a
dog’s lungs determines if dead air space is a problem. A 20
pound pug with a short
nose has roughly the same tidal volume as a 20 pound
Whippet with a long
nose. The length of the nose is irrelevant. Use of a
non-rebreather for small dogs
is useful whether using the Safe-Seal tube or the
conventional inflation cuff
tubes.
9. Who has been
using this tube?
Many veterinarians have
participated in our trials, including board certified
doctors. Some of their
testimonials are included in this web site. The response
has been overwhelmingly
positive. Check them out!
10. How do I
determine the correct size of tube to use?
There is tremendous variation
in the size of the trachea and larynx between
different breeds of dogs. As a general guide line the small tube
will properly fit dogs
ranging from 10 to 30 pounds. The
middle size tube will usually work in dogs from 25 and
up to
80 pounds and the large tube will work well in dogs
from 70 to 200 pounds. A
simple rule of thumb is if the tube feels too tight or too loose upon insertion,
use the next
size tube, smaller or larger as appropriate.
11. Why do I hear
air leakage sometimes when I first insert the
Tube?
If a patient is “light”
when first intubated, he may cough or forcefully expire.
The baffles will release
pressure exceeding 20-30 centimeters of water. So when
first tubed, a “honking”
sound of this pressure release is normal. When the
patient is
breathing normally, no leakage will occur. In either
case, there will be no leakage during
inspiration, so
the patient will be receiving all the oxygen and anesthetic he requires.
12. What is the
proper method of inserting the tube?
The stylet included with
the tubes is necessary due to the flexibility of the tube.
Insert the tube in the
usual fashion and stop inserting while the tube is in a
forward motion.
This will insure the baffles will seal the trachea and allow
Excess pressure to
escape. Remove the stylet and secure the tube to the snout
in the usual ways.
13. Can positive
pressure be applied?
Yes, 20-30 centimeters of
pressure can be applied. If the operator desires more
pressure, the tube is
merely withdrawn ½ inch, and the baffles will flip over and
as
much pressure as deemed necessary is available.
14. Why does the
Safe-Seal tube cause no threat of damage to the Trachea?
There is minimal contact
with the tracheal mucosa with the Safe-Seal ET
tube
and the pressure caused by the bending of the baffles varies between 1-3
centimeter of
water. Inflation cuff tubes have a large area of tracheal
contact and require up to 30
centimeters of water pressure to seal.
If inadvertent movement of the tube occurs,
the tube will rotate and
not cause friction damage to the mucosa. The
baffles keep the tip of
the ET tube centered in the trachea at all times, thus not allowing
pressure points typical of inflation cuff tubes.
15. Sterilization Recommendations:
Method:
Steam sterilize the product using the following parameters after
removing all non-autoclavable protective packaging and labeling:
Cycle:
High Vacuum, Temperature 270 F (132 C), 4 minutes of exposure
Cycle:
Gravity, Temperature 270 F (132 C), 10 minutes of exposure
Cycle:
Vacuum, Temperature 270 F (132 C), 10 minutes of exposure
16. "I feel that I have to use too
much pressure to insert the Tube. Is this a problem?":
No.
After over 6000 procedures performed in trials, no problems have
arisen to suggest
that this is a problem. The
pressure you feel while inserting the tube is created by the
bending of the baffles at the level
of the arytenoid cartilages which are very tough. The
needed pressure of the baffles (Blaines)
is about 3 centimeters of water. An inflated cuff
on traditional tubes exerts 20-30
centimeters of water - which is about 10 times the
additional pressure in a more
sensitive area then the passage of the Blaines through the
arytenoids. The amount of
pressure or resistance that you feel is similar to the pressure
you feel when passing a large stomach
tube down the esophagus. Lubrication of the
baffles either with water or KY is
beneficial in reducing the friction at the arytenoids.
17.
What if we see
some blood when we remove the Tube?
During the first 3 years of
our clinical trials on real patients, if blood was noticed on the
Tube the source was investigated. In most cases the blood came from
the oral cavity from
procedures such as dentals. All of the other cases the dogs were
scoped and found
pathology such as inflammed
glottis or larynx caused by coughing, barking,
viruses, etc. Remember that
any blood or fluid in the throat is
removed by the Safe-Seal Tube and is
therefore visualized. With
inflation cuff Tubes, the
blood remains in the trachea and is not seen.
18.
Why is it hard to remove the stylet while the Safe~Seal Tube is
in the patient? The
head and the neck of the dog needs to be straight in alignment.
Align the nose straight to the thoracic inlet,
then remove the stylet from
the Tube.
Back to Top |
