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Rocket Medical KCH Instrucciones De Uso

Drenaje vesical para el feto

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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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Resumen de contenidos para Rocket Medical KCH

  • Página 1 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.
  • Página 2 Deciding if fetal bladder drainage is best for you and your baby: The decision to have the placement of the Rocket® KCH™ Catheter or any other procedure to relieve the urinary pressure is an important decision and is up to you and your partner.
  • Página 3 The Rocket® KCH™ Catheter will only allow urine to drain from the baby’s bladder so that your baby’s lungs and kidneys can continue to grow without pressure during pregnancy.
  • Página 4 As with many internal procedures during pregnancy there is a risk of premature labour. Placement of the KCH™ Catheter may reduce the risk of renal damage, however it does not completely remove the risk that the baby may have co-existing renal or pulmonary impairment on delivery and there may be the need to subsequently perform a renal transplant sometime in the future.
  • Página 5 Remove the trocar and further aspirate sufficient urine to prevent back flow up the open cannula. Remove the seal from the cannula. The KCH™ catheter, with its forming wire in place, (Fig.2) is then unrolled gently by hand. Remove the forming wire and red pusher and substitute with the semi rigid guidewire.
  • Página 6 La sonde vésicale foetale du Kings College Hospital (Londres) ou “Rocket® KCH™ Catheter” est conçue pour contribuer à réduire la pression sur les voies urinaires du bébé. Le Rocket® KCH™ Catheter permet à l’urine de circuler de la vessie du bébé à la poche amniotique, en évitant les voies urinaires du bébé...
  • Página 7 ? La décision de poser le cathéter Rocket® KCH™ ou tout autre procédure visant à diminuer la pression urinaire est une décision importante qui doit être prise par vous ou votre partenaire. Vous n’êtes pas obligée de vous soumettre à cette procédure.
  • Página 8 Elle ne peut corriger l’obstruction des voies urinaires de votre bébé, car cela devra être traité après la naissance de votre bébé. Le cathéter Rocket® KCH™ permettra à l’urine de sortir de la vessie du bébé afin que les poumons et les reins de votre bébé puissent continuer leur croissance sans pression pendant la grossesse.
  • Página 9: Contre-Indications

    Comme c’est le cas avec nombre de procédures internes pendant la grossesse, il existe un risque d’accouchement prématuré. La pose du cathéter KCH™ peut réduire le risque de lésion rénale ; toutefois, elle n’exclut pas complètement le risque que le bébé puisse souffrir d’une déficience rénale ou pulmonaire co-existante à...
  • Página 10: Consignes D'UTilisation

    Enlever le bouchon de la canule. Le cathéter KCH™, avec son fil en forme de boucle, (Fig.2) est ensuite enroulé à la main. Enlever le fil en forme de boucle et le poussoir rouge et les remplacer par un fil-guide semi- rigide.
  • Página 11 Die fötale Blasendrainage des Kings College Hospital (London) oder “Rocket® KCH™ Katheter” wurde entwickelt, um den Druck in den Harnwegen von Babys zu entlasten. Der Rocket® KCH™ Katheter ermöglicht den Abfluss des Urins aus der Harnblase des Kindes in die Fruchtblase, indem die Harnwege umgangen werden und damit der Druck entlastet wird.
  • Página 12 48-72 Stunden nach dem Eingriff angesetzt, und normalerweise werden weitere Ultraschalluntersuchungen jede Woche angesetzt, bis Ihr Kind auf die Welt kommt. Der Arzt wird die Lage des Rocket® KCH™ Katheters überwachen, und sicherstellen, dass der Katheter richtig funktioniert. Manchmal kann der Katheter durch Bewegungen des Babys aus der Blase gezogen, umgeknickt oder blockiert werden.
  • Página 13 Problem behebt. Der Katheter entfernt die Blockade im Harnweg Ihres Babys nicht. Dieser Zustand muss nach Geburt Ihres Kindes behandelt werden. Der Rocket® KCH™ Katheter ermöglicht nur die Entleerung der Blase Ihres Babys, so dass die Lunge und die Nieren Ihres Kindes weiterhin während der Schwangerschaft ohne Druck wachsen können.
  • Página 14 KLINISCHE ERFAHRUNG Anmerkung: Klinische Studien haben die Sicherheit und Wirksamkeit von fötalen Blasen-Stents nicht belegt. Manche Studien bieten jedoch mäßige Zusicherung der Sicherheit dieser Technik. Zusätzlich gibt es berichtete klinische Erfahrung mit KCH™ Kathetern in mehr als 20 Jahren Nutzung.
  • Página 15 Rückfluss in die offene Kanüle gibt. Entfernen Sie das Siegel der Kanüle. Der KCH™ Katheter mit dem platzierten Formdraht (Abb.2) wird dann vorsichtig per Hand ausgerollt. Entfernen Sie den Formdraht und den roten Pusher und platzieren Sie an desses Stelle den halbstarren Führungsdraht.
  • Página 16 Potrebbe inoltre provocare malformazioni fisiche gravi. Il tubo di drenaggio per vescica fetale o “Catetere Rocket® KCH™” del Kings College Hospital (Londra) è stato ideato per alleviare la pressione nel tratto urinario del bambino. Il catetere Rocket® KCH™ permette all’urina di scorrere dalla vescica del bambino al sacco amniotico, aggirando il tratto urinario del bambino e alleviando, quindi, l’accumulo di pressione.
  • Página 17 Il medico controllerà la posizione del Catetere Rocket® KCH™ e ne verificherà il corretto funzionamento. Talvolta, se il bambino si muove o lo afferra, il catetere potrebbe uscire dalla vescica del suo bambino o potrebbe attorcigliarsi o ostruirsi.
  • Página 18 Non permette di correggere l’ostruzione del tratto urinario, la quale dovrà essere curata dopo la nascita del bambino. Il Catetere Rocket® KCH™ permetterà solo di drenare l’urina dalla vescica del bambino affinché i suoi polmoni e reni possano continuare a crescere privi di pressione durante la gravidanza.
  • Página 19 Il medico deve aver raggiunto la conclusione che i rischi per il feto sono maggiori rispetto ai rischi potenziali dell’uso del dispositivo. Si raccomanda di eseguire tali analisi per stabilire se il feto possa essere trattato con il Catetere KCH™...
  • Página 20 Gli esami a ultrasuoni devono essere effettuati settimanalmente per il resto della gravidanza al fine di assicurare il funzionamento continuativo dello shunt. Rimozione: Il catetere KCH™ può essere rimosso usando le tecniche asettiche convenzionali, in seguito a una valutazione pediatrica urologica soddisfacente.
  • Página 21: Drenaje Vesical Para El Feto Rocket Kch

    El drenaje vesical para el feto del Hospital Kings College (Londres) o "catéter Rocket® KCH™" está diseñado para ayudar a aliviar la presión en el tracto urinario del bebé. El catéter Rocket® KCH™ permite que la orina fluya desde la vejiga del bebé hasta el saco amniótico, evitando el tracto urinario del bebé, aliviando así...
  • Página 22 Decidir si el drenaje vesical del feto es lo mejor para usted y su bebé: La decisión de someterse a la colocación del catéter Rocket® KCH™ o a cualquier otro procedimiento para aliviar la presión urinaria es una decisión importante y depende de usted y de su pareja.
  • Página 23 El catéter Rocket® KCH™ solo permitirá drenar la orina desde la vejiga del feto para que los pulmones y riñones del bebé puedan seguir desarrollándose sin presión durante el embarazo.
  • Página 24: Contraindicaciones

    Como muchos procedimientos internos, durante el embarazo existe el riesgo de parto prematuro. La colocación del catéter KCH™ puede reducir el riesgo de daño renal, sin embargo no elimina por completo el riesgo de que el bebé pueda coexistir con el deterioro renal o pulmonar en el parto y puede producirse la necesidad de realizar posteriormente un trasplante renal en algún momento en el futuro.
  • Página 25 Extraiga el trócar y aspire orina suficiente para evitar el retorno de la orina por la cánula abierta. Retire el sello de la cánula. El catéter KCH™, con su cable formado en su sitio, (fig. 2) se desenrolla cuidadosamente con la mano. Extraiga el cable formado y el empujador rojo y sustitúyalo con el cable guía semirrígido.