K9 Safe Seal

     

   Product Information

   

 

 

How the Safe~Seal™ Works

Directions and Packaging Insert

Frequently Ask Questions:

  1.  What makes this endotracheal tube better?
  2.  How long will it last?
  3.  Do I need to worry about the tube kinking?
  4.  What about sterilization and cleaning?
  5.  How many tubes do I need?
  6.  Will water or fluids leak past the tube during procedures dentals?
  7.  How does the tube prevent over pressurization of the lungs patient?
  8.  What about “dead air space’ in small, brachiocephalic breeds?
  9.  Who has been using this tube?
 10.  How do I determine the correct size of tube to use?
 11.  Why do I hear air leakage sometimes when I first insert the Tube?
 12.  What is the proper method of inserting the tube?
 13.  Can positive pressure be applied?
 14.  Why does the
Safe~Seal tube cause no threat of damage to the
          Trachea?

 15.  Sterilization recommendations
 16.  I feel that there is too much pressure to insert the tube.  Is this a
         problem?

 17.  What if we see see blood when we remove the Tube?
 18.  Why is it hard to remove the stylet while the Tube is in the patient? 

  
 

 

                 

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pressure is desired, the tube is merely withdrawn inch causing the baffles to flip over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 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 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

 
 
   

 

 

Do you have a new medical device idea? Click here   We would like to hear from you.  Our mission is to deliver high quality
design, development and manufacture of new medical devices ideas and products that change our lives for the better.

 

 

 

 

2010  Innovative Animal llc.

 

 

v1