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

This application is a continuation of U.S. patent application Ser. No. 11/179,121, filed on Jul. 12, 2005, which is incorporated herein by reference in its entirety.

This patent document pertains generally to cardiac rhythm management systems and methods, and more particularly, but not by way of limitation, to cardiac rhythm management systems and methods for fetal, neonatal, and/or pediatric patients.

Antiarrhythmia therapies such as pacing and defibrillation frequently involve delivery of an electric signal to the heart or to anatomy near the heart. Pacing therapies include delivery of a low-energy electrical pulse to the heart. Defibrillation therapies typically include delivery of an electrical energy signal that is strong enough to defibrillate the heart.

A pacer device typically includes a pulse generator and an electrode through which an electrical signal is delivered to the heart. A defibrillator typically includes a pulse generator and two or more electrodes through which an antitachyarrhythmia therapy is delivered. Some devices include both pacing and defibrillation capability. In an example, a medical device includes a lead assembly having at least one electrode that is positionable in, on, and/or around the heart. An antiarrhythmia therapy is delivered using the at least one electrode. In mature patients, a medical device such as a pacer or defibrillator is usually implanted in the thorax, with leads extending from the medical device and into a vein that leads into the heart. A pulse generator is frequently implanted subcutaneously, for example.

In small patients, especially in utero patients, implantation of subcutaneous devices and lead assemblies can be complicated because of the small, fragile, rapidly-growing anatomy of the patient. Improved cardiac rhythm management methods and systems for fetal, neonatal and/or pediatric patients are needed.

An example method includes 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, inserting an electrode into an umbilical vein includes inserting the electrode in utero. In an example, inserting an electrode into an umbilical vein includes inserting a lead assembly into the umbilical vein, the lead assembly including the electrode. The method optionally further includes coupling a pulse generator to the lead assembly and coupling the pulse generator to a placenta or the umbilical vein. In another example, the method further includes forming a coil or loop in the lead assembly, the coil or loop accommodating growth of cardiac or venous anatomy. In another example, inserting a lead assembly into the umbilical vein includes inserting the lead assembly through a slip suture sleeve. In another example, the method further includes coating a portion of the lead assembly with an adhesion-preventing drug-eluting coating or covering a portion of the lead assembly with ePTFE. The method optionally further includes delivering a pacing signal or antitachyarrhythmia signal using the electrode. In an example, inserting an electrode into an umbilical vein includes catheterizing an umbilicus after birth or surgically accessing an abdominal region and inserting the electrode into the umbilical vein at a location inside the abdomen.

Another example method includes inserting a first defibrillation electrode into an umbilical vein, and advancing the first defibrillation electrode to a location in or near a heart. In an example, advancing the first defibrillation electrode to a location in or near a heart includes advancing the first defibrillation electrode to a position that is near the heart but not in the heart. The method optionally further includes inserting a second defibrillation electrode in the umbilical vein and advancing the second defibrillation electrode to an intrathoracic position. In an example, advancing the second defibrillation electrode to an intrathoracic position includes advancing the second defibrillation electrode to a location in or near the abdomen. The method optionally further includes delivering an electrical signal using the first defibrillation electrode and the second defibrillation electrode.

In an example, inserting a first defibrillation electrode into an umbilical vein and inserting a second defibrillation electrode in the umbilical vein include inserting a lead assembly into the umbilical vein, the lead assembly including the first defibrillation electrode and the second defibrillation electrode. In another example, advancing the first defibrillation electrode to a location in or near a heart includes advancing the first defibrillation electrode through the heart and into the superior vena cava (SVC). In another example, advancing the defibrillation electrode to a location in or near a heart includes positioning the electrode in the inferior vena cava (IVC). The method optionally includes implanting a pulse generator, coupling the pulse generator to the first defibrillation electrode and second defibrillation electrode, and delivering an electrical signal using the first defibrillation electrode and a second defibrillation electrode. In an example, implanting a pulse generator includes implanting the pulse generator in a left abdominal position. The method optionally includes coupling a lead assembly to the pulse generator and positioning a portion of the lead assembly including the second defibrillation electrode superior to the pulse generator, or in an inferior vena cava (IVC).

Another example method includes delivering an antiarrhythmia therapy using a lead assembly extending through an umbilical vein. In an example, delivering an antiarrhythmia therapy includes delivering the therapy in utero. In another example, the lead assembly includes a first defibrillation electrode and delivering an antiarrhythmia therapy includes delivering an antitachyarrhythmia therapy using the first defibrillation electrode. In another example, delivering an antiarrhythmia therapy using a lead assembly extending through an umbilical vein includes delivering an antiarrhythmia therapy through a catheterized umbilicus after birth. In an example, delivering an antiarrhythmia therapy using a lead assembly extending through an umbilical vein includes delivering the antiarrhythmia therapy through a lead assembly surgically implanted into the umbilical vein through an abdominal incision. In another example, delivering an antiarrhythmia therapy includes delivering the antiarrhythmia therapy using a first electrode on the lead assembly and a second electrode on a second lead assembly extending into the inferior vena cava.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of a fetus, a placenta, a lead assembly inserted into an umbilical cord, and a pulse generator coupled to the lead assembly.

FIG. 2 is an illustration of a child patient and a lead assembly inserted through a catheterized umbilicus.

FIG. 3 is an illustration of a patient and a lead assembly extending from a medical device through an umbilical vein toward the patient\'s heart.

FIG. 4 is an illustration of a patient, a first lead assembly extending from a medical device into a patient\'s heart, and a second lead assembly extending into or onto the patient.

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System for heart monitoring, characterization and abnormality detection
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