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 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.
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 FIELDThis 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.
BACKGROUNDAntiarrhythmia 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.
SUMMARYAn 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.
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.
A lead assembly, catheter, or other medical device is inserted into an umbilical vein of a fetus or young child. The umbilical vein provides a pathway to the heart, through which a therapeutic device can be delivered. In an example, a lead assembly is implanted in an in utero procedure. In an example, the lead assembly allows for growth of the child or fetus, for example by including an expandable structure such as one or more looped portions or coiled portions. In an example, a pulse generator is coupled to a placenta and to the lead assembly. In an example, antiarrhythmia therapy is delivered before, during, and/or after the birthing process. In another example, a lead assembly is implanted in a child shortly after the child is born. After birth, the umbilical vein remains open (internally) for a period of time, during which time a lead assembly (or other device) can be inserted through the umbilical vein. The umbilical vein eventually occludes, typically approximately a week after birth.
Implanting a lead assembly through an umbilical vein can provide a number of advantages. In some examples, cardiac rhythm management therapy is delivered to high-risk fetuses. In an example, an electrode is positioned in or near the heart more quickly and/or easily via the umbilical vein than can be done surgically through a cardiac vein, such as through the superior vena cava. In some examples, an increased number of therapeutic combinations and/or options are available using an umbilical vein than are normally available through a surgically-accessed cardiac vein. In an example, a fetus is treated in utero and allowed to approach full term, and pre-term labor is avoided or reduced. In an example, an umbilically-implanted lead assembly is more compatible with fetal or infant growth than a lead assembly surgically inserted through a cardiac vein. In an example, a lead assembly and pulse generator is deliverable with an infant through normal birth, i.e. the devices are deliverable through the birth canal, or through a caesarian section. In an example, a device and lead is capable of delivering therapy during labor and birth. In an example, a lead assembly in an umbilical cord avoids risk of entanglement with a fetus because the lead assembly extends inside the umbilical cord. In an example, an umbilically-implanted lead assembly avoids or reduces the use or occlusion of permanent vessels in the peripheral vasculature. In an example, an umbilically-implanted lead assembly provides a bridge to adult and/or conventional cardiac rhythm management device, for example by allowing a child to grow until the cardiac and other anatomy can accommodate a subcutaneous device connected to a lead that is placed in, on, or around the heart through the peripheral vasculature.
Various example techniques include inserting a lead assembly or other device through the umbilical vein. In an example, a pacing therapy is delivered through an umbilically-implanted lead assembly. In another example, a defibrillation therapy or other antitachyarrhythmia therapy is delivered using multiple electrodes on a lead assembly, electrodes on separate lead assemblies, or an electrode on a lead assembly and an electrode coupled to a medical device housing or “can.”
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In an example, the medical device 410 is implanted in a left thoracic location, such as a left side of the abdomen. In an example, a second electrode 415 is coupled to the device 410. In an example, a second lead assembly 420 includes the second electrode 415 and couples the electrode to the medical device 410. In an example, the second electrode 415 is positioned superior to the device 410. In an example, the second electrode 415 is positioned at a location that is below the heart 401 when the infant is in a vertical (i.e. standing) position. In another option, the electrode is connected directly to the medical device, and the second lead assembly 420 is optionally omitted. An antitachyarrhythmia therapy is deliverable through the electrodes 405, 415. In an example, an electrical field generated by the electrode is sufficient to defibrillate a majority or all of the heart 401.
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In an example, slack is provided in the lead assembly, so that the lead assembly can slide and/or expand in the umbilical vein as the fetus/child and umbilical vein grow in length.
In an example, a lead assembly includes a coating that prevents tissue ingrowth. In an example, a coating such as ePTFE is provided on the lead assembly to prevent tissue ingrowth. In another example, a drug eluting coating is provided on the lead assembly.
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While the methods, systems, and devices have been shown and described herein with respect to a human patient, it is understood that the methods, systems and devices can also be applied to animals, such as pigs or dogs, in therapeutic and/or experimental applications.
The above specification, examples and data provide a complete description of the manufacture and use of the composition of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.
Claims
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.
Type: Application
Filed: Jun 22, 2009
Publication Date: Oct 15, 2009
Inventors: Ronald W. Heil, JR. (Roseville, MN), Beverly Mains (Minneapolis, MN), Christopher P. Knapp (Ham Lake, MN), Kyle Hoecke (Lino Lakes, MN)
Application Number: 12/489,376
International Classification: A61N 1/362 (20060101);