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




Title: 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. ...


USPTO Applicaton #: #20090259270
Inventors: Ronald W. Heil, Jr., Beverly Mains, Christopher P. Knapp, Kyle Hoecke


The Patent Description & Claims data below is from USPTO Patent Application 20090259270, Cardiac rhythm management for fetal, neonatal, and/or pediatric patients.

RELATED APPLICATIONS

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.

TECHNICAL FIELD

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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.

BACKGROUND

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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.

SUMMARY

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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

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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.

FIG. 5 is an illustration of a patient, a first lead assembly extending from a patient toward the patient\'s heart, and a second lead assembly inserted into the patient\'s inferior vena cava.

FIG. 6 is an illustration of internal organs, vasculature, an umbilical vein, a placenta, and a lead assembly extending from a medical device into the umbilical vein and toward the heart.

FIG. 7 is an illustration of internal organs, vasculature, an umbilical vein, a placenta, and a lead assembly extending from a medical device into the umbilical vein and into the heart.

FIG. 8A is an illustration of internal organs and vasculature, an umbilical vein, a placenta, a first lead assembly extending from a medical device into the umbilical vein and toward the heart, and a second lead assembly extending from a medical device into the umbilical vein and into the heart.

FIG. 8B is an enlarged view of a portion of FIG. 8A showing the first and second lead assemblies extending into the umbilical vein.

FIG. 8C is an enlarged view of an alternate configuration in which the first and second lead assemblies extending into a single suture sleeve and then into the umbilical vein.

FIG. 8D is an enlarged view of a portion of FIG. 8A showing the first lead assembly approaching but not entering the heart and the second lead assembly extending into the heart.

FIG. 9 is illustration of a lead assembly in a blood vessel.

FIG. 10 is a schematic illustration of an implantable medical device.

FIGS. 11 and 12 are flow charts that illustrate example methods.

DETAILED DESCRIPTION

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The following detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as “examples.” The following detailed description is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents.




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System for heart monitoring, characterization and abnormality detection
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Method and apparatus for detecting and treating tachyarrhythmias incorporating diagnostic/therapeutic pacing techniques
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stats Patent Info
Application #
US 20090259270 A1
Publish Date
10/15/2009
Document #
File Date
12/31/1969
USPTO Class
Other USPTO Classes
International Class
/
Drawings
0


Neonatal Pediatric Umbilicus

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Surgery: Light, Thermal, And Electrical Application   Light, Thermal, And Electrical Application   Electrical Therapeutic Systems   Heart Rate Regulating (e.g., Pacing)   Treating Or Preventing Abnormally High Heart Rate  

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20091015|20090259270|cardiac rhythm management for fetal, neonatal, and/or pediatric patients|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 |
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