Cardiac rhythm management for fetal, neonatal, and/or pediatric patients

Abstract

A method including inserting an electrode into an umbilical vein, and advancing the electrode through the umbilical vein to a location near or in a heart. In an example, the electrode is inserted into an umbilical vein in utero. In another example, the electrode is inserted into an umbilical vein in a child soon after the child is born. In an example, the electrode is connected to a lead. In an example, a lead is inserted through a catheterized umbilicus.

1 . A method comprising:
 inserting a lead assembly including an electrode into an umbilical vein, including inserting the electrode in utero;   advancing the lead assembly including the electrode through the umbilical vein to a location near or in a heart;   coupling a pulse generator to the lead assembly and securing the pulse generator to a placenta, wherein securing the pulse generator to the placenta includes securing the pulse generator directly to the placenta; and   implanting the pulse generator within a fetal patient, a neonatal patient, or a pediatric patient.   
   
   
       2 . The method of  claim 1 , further comprising forming a loop in the lead assembly, the loop accommodating growth of cardiac or venous anatomy of a fetus. 
   
   
       3 . The method of  claim 1 , further comprising coating a portion of the lead assembly with an adhesion-preventing drug-eluting coating. 
   
   
       4 . The method of  claim 1 , further comprising covering a portion of the lead assembly with ePTFE. 
   
   
       5 . The method of  claim 1 , further comprising delivering a pacing signal or antitachyarrhythmia signal using the electrode. 
   
   
       6 . The method of  claim 5 , wherein delivering the pacing signal or antitachyarrhythmia signal using the electrode includes delivering a therapy signal during a birthing process. 
   
   
       7 . A method comprising:
 inserting a lead assembly including an electrode into an umbilical vein, including inserting the electrode in utero;   advancing the lead assembly including the electrode through the umbilical vein to a location near or in a heart;   coupling a pulse generator to the lead assembly and securing the pulse generator to the umbilical vein, securing the pulse generator to the umbilical vein includes coupling the pulse generator to the umbilical vein; and   implanting the pulse generator within a fetal patient, a neonatal patient, or a pediatric patient.   
   
   
       8 . The method of  claim 7 , further comprising forming a coil or loop in the lead assembly, the coil or loop accommodating growth of cardiac or venous anatomy of a fetus. 
   
   
       9 . The method of  claim 7 , wherein inserting the lead assembly into the umbilical vein includes inserting the lead assembly through a slip suture sleeve. 
   
   
       10 . The method of  claim 7 , further comprising coating a portion of the lead assembly with an adhesion-preventing drug-eluting coating. 
   
   
       11 . The method of  claim 7 , further comprising covering a portion of the lead assembly with ePTFE. 
   
   
       12 . The method of  claim 7 , wherein inserting the electrode into an umbilical vein includes surgically accessing an abdominal region and inserting the electrode into the umbilical vein at a location inside the abdomen. 
   
   
       13 . The method of  claim 7 , further comprising delivering a pacing signal or antitachyarrhythmia signal using the electrode. 
   
   
       14 . The method of  claim 13 , wherein delivering the pacing signal or antitachyarrhythmia signal using the electrode includes delivering a therapy signal during a birthing process. 
   
   
       15 . The method of  claim 7 , wherein inserting the lead assembly into the umbilical vein and securing the pulse generator to the placenta or the umbilical vein includes implanting the lead assembly and pulse generator to be deliverable with an infant through normal birth. 
   
   
       16 . A method comprising:
 inserting a lead assembly including an electrode into an umbilical vein, including inserting the electrode in utero;   advancing the lead assembly including the electrode through the umbilical vein and through the inferior vena cava to a location near or in a heart;   coupling a pulse generator to the lead assembly and securing the pulse generator to the umbilical vein, securing the pulse generator to the umbilical vein includes coupling the pulse generator to the umbilical vein; and   implanting the pulse generator within a fetal patient, a neonatal patient, or a pediatric patient.   
   
   
       17 . The method of  claim 16 , wherein inserting the lead assembly into the umbilical vein includes inserting the lead assembly through a slip suture sleeve. 
   
   
       18 . The method of  claim 16 , further comprising coating a portion of the lead assembly with an adhesion-preventing drug-eluting coating. 
   
   
       19 . The method of  claim 16 , wherein inserting the lead assembly into the umbilical vein and securing the pulse generator to the umbilical vein includes implanting the lead assembly and pulse generator to be deliverable with an infant through normal birth.