Rocket Medical Rocket KCH Gebrauchsanweisung

Rocket KCH™ Fetal Bladder Drain
PATIENT INFORMATION
Scope: This information covers R57405 Rocket KCH™™ Fetal Bladder Drain and derivatives
Humanitarian Device: Authorised by Federal law for use in the treatment of Fetal Obstructive Uropathy.
The effectiveness of this device has not been demonstrated.
Definitions

Amniocentesis: A procedure in which a sample of
the amniotic fluid is taken and studied.

Amniotic Sac: The space around your baby which
is filled with fluid.

Chorioamnionitis: An inflammation of the
membrane surrounding your baby.

Chorionic Villus Sampling (CVS): A procedure in
which a sample of the tissue in the placenta is
taken and studied.

Fetal Karyotype: A study of your baby's
chromosomes.

Gestational Age: The time that has passed since
your baby's conception.

Lower Obstructive Uropathy: A blockage in the
urinary tract below the bladder.

Maternal Sepsis: An infection in the mother.

Open Fetal Surgery: The partial removal of a fetus from the uterus so surgery can be performed to correct a defect.

Urinary Ascites: The leaking of urine into your baby's abdomen.

Urinary Tract: The system which removes urine from the body.

Catheter: A tube inserted into a body cavity to allow movement of fluid.

Infuse: The addition of fluid into the body.

Ultrasound: This is how a doctor can look at your baby on a television screen.
Why is there pressure in my baby's urinary tract?
In normal pregnancy a baby's urine will drain from the kidneys into the bladder and then through the urinary tract and into the
amniotic sac. It appears that this is not happening with your baby who has a condition know as lower obstructive uropathy. This
means that there may be a blockage in your baby's urinary tract and the urine cannot flow freely into the amniotic sac.
This will cause pressure to build up in the urinary tract and if left untreated, could cause damage to your baby's lungs and kidneys.
In severe cases this damage could lead to stillbirth or could cause your baby to die shortly after birth because the lungs or kidneys
fail. It could also cause severe physical deformities.
The Kings College Hospital (London) Fetal Bladder Drain or "Rocket® KCH™ Catheter" is designed to help relieve the pressure in
the baby's urinary tract. The Rocket® KCH™ Catheter allows the urine to flow from the baby's bladder into the amniotic sac, by-
passing the baby's urinary tract and thus relieving the pressure build-up.
Can my baby benefit from this procedure?
Your doctor will advise you if you and your baby are suitable for this procedure, typically your baby may benefit if:

Your pregnancy is between 18 to 32 weeks and has a blocked urinary tract.

Your baby shows no physical deformities under a detailed ultrasound.

A study of your baby's chromosomes, also called a fetal karyotype, shows no other serious defect.
When can this procedure be performed?
A doctor can perform this procedure if your baby is not less than 18 weeks but no older than 32 weeks gestational age. Since each
case is different, your doctor will be able to give you more information about you and your baby.
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