Transcript GentleHeel, Heel Incision System

Bringing Medical Innovation
to the World
GentleHeel, Heel Incision System
www.crossbaymedicalinc .com
Newborn Screening: Heel
Incisions
Neonatal screening test
Heel sample
Heel incision system- GentleHeel
Competitor analysis
Comparison table
Neonatal screening test
ESSENTIAL FOR:
1. The search for harmful or potentially fatal disorders that are
not evident at birth
• Metabolic disorders, often called "inborn errors of metabolism"
may interfere with the use of nutrients to the body to maintain
healthy tissue and produce energy
• Other disorders that can be detected through screening include
problems or hormonal blood
2. Evidence of disturbances that can interfere with normal
physical and mental development of a newborn
3. Evidence of disturbances that can interfere with normal
physical and mental development of a newborn
Neonatal screening test
All regions perform screening (Guthrie test) for:
1. PKU
2. congenital hypothyroidism
- Thyroid hormone deficiency leads to retarded growth and brain
development
- If detected early a child can be treated with oral doses of
thyroid hormone to permit normal development
- Incidence: 1 in 4,000
Robert Guthrie (June 28, 1916 Seattle, June 24, 1995) was an
American microbiologist. He is
remembered for being the first to test
using whole blood dried on paper in the
60
Neonatal screening test
Metabolic disorder
• Children with PKU lack an enzyme needed to process the amino acid
phenylalanine.
• This amino acid is necessary for normal growth in infants and young
children and for the normal use of the protein throughout life.
• high can damage brain tissue and can cause mental retardation.
Treatment of PKU
• Following an early system of special diet can often prevent mental
retardation and with certain restrictions in diet, these children can lead
a normal life
Since the development of the PKU test in the '60s, researchers
have identified additional blood tests to screen newborns for
other disorders, which if not detected and treated early, can cause
physical problems, mental retardation and in some cases death
Neonatal screening test
Technology able to detect blood components that are elevated in
certain disorders, and able to screening for more than 20
metabolic diseases with a single sample.
Newborn Screening: Heel
Incisions
Neonatal screening test
Heel sample
Heel incision system- GentleHeel
Competitor analysis
Comparison table
Heel sample: When and why?
• To obtain a blood sample from the infant /child up to 2 years
• For screening for congenital disorders (Guthrie test)
• Levied on the outside of the heel:
• More secure than a venipuncture
• The baby's fingers are too small to obtain an adequate sample
• Avoid phlebotomy or peripheral vascular plants, risk of bleeding
Collection of metabolic
screening:
The sample must be
sent to the Regional
Collection Center
Heel sample:
Issues/Complications
1. Excessive squeezing:
• May cause hemolysis of the sample
• Force accumulation of debris in the sample site
• Inhibits the natural flow of blood
• Can cause coagulation
• Jeopardizes future withdrawals due to trauma
2. Osteomielitis :
• If the incision is too deep, can cause inflammation of bone and
bone marrow
3. infection:
• If a sterility is not maintained (device / heel)
4. Insufficient sample or compromise:
• Consequent need to perform a second puncture
Newborn Screening: Heel
Incisions
Neonatal screening test
Heel sample
Heel incision system- GentleHeel
Competitor analysis
Comparison table
GentleHeel
The GentleHeel, unique in its kind, combines
the precision of the mechanism activated by a
calibrated steel spring and a surgical cutting
blade with very sharp grinding.
The quality of the cutting blade associated to a
arc incision ensures less traumatic
withdrawals, compared to the “puncture”
systems consequently, a significant reduction
of the vasoconstriction caused by pain, which
is also due to insufficient sample of blood.
GentleHeel
The sharp steel surgical blade allows a painless incision of the capillary
and quicker healing. Blood flow from the capillary sampling is abundant
and requires no painful "squeezing" of the heel which can alter the
chemical values ​of blood sampling.
The blood sample obtained with GentleHeel is comparable to a sample
of arterial blood. This enables multiple analyses (blood gases,
laboratory tests with micro-method, etc..) without having to resort to
traditional methods of sampling.
GentleHeel
The packaging of each individual device is sterile for maximum control
of infections. In this regard, the use of the right size of the GentleHeel
ensures adequate sampling of blood with a single incision and
minimizes the recall of infants to repeat the Guthrie test .
The right measure of GentleHeel is easy recognized thanks to the color
codes:
GentleHeel
• depth. 0.65 mm - length. 1.40 mm
micro preemie: • (for children weighing between 0.6 and 1.0 kg.)
GentleHeel
preemie:
• depth. 0.85 mm - length. 1.75 mm
• (for babies weighing < 1.5 kg.)
GentleHeel
newborn:
• depth. 1.0 mm - length. 2.5 mm
• (for normal weight children)
GentleHeel
Toddler:
• depth. 2.0 mm - length. 3.0 mm
• (for children weighing > 5 kg.)
Bringing Medical Innovation
to the World
Thank You
www.crossbaymedicalinc .com