Fetal Pacemaker Segmentation for Electrode Stability
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Solution Overview
Problem
Current fetal pacemakers fail due to dislodgement caused by fetal movement within the uterus, and existing designs for adult pacemakers are not suitable for infants or children, particularly in cases where venous access is difficult.
Innovation Solution
A fully implantable cardiac pacemaker with short leads and a device assembly that includes a pusher and holder, allowing for minimally invasive implantation and extended functionality without dislodgement, suitable for fetuses, infants, children, and adults, using a trocar for deployment and a controller to manage pacing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a long lead is used to connect the electrode to the power supply in fetal pacemakers, then the pacemaker can be placed outside the uterus, but the electrode becomes dislodged due to fetal movement
Solution Approach 1:
The invention extracts the power supply from the fetal environment and places it in the maternal environment, eliminating the need for a long lead traversing the uterine wall. The electrode remains inside the fetal heart while the power supply is positioned in the maternal abdominal wall or subcutaneous tissue, thereby maintaining electrode stability while enabling external power supply placement.
Solution Approach 2:
The invention introduces an intermediary structure (the transuterine lead with electrode at the tip) that allows the power supply to be positioned outside the uterus while still delivering electrical stimulation to the fetal heart. The lead acts as a mediator that crosses the uterine wall barrier, enabling communication between the maternal environment (power supply) and fetal environment (electrode contact point).
2Reliability
If a fully implantable pacemaker is used in fetuses, then the electrode remains stable, but the device size becomes too large for the fetal chest cavity
Solution Approach 1:
The pacemaker system is segmented into two separate components positioned in different environments: the electrode (stimulation component) is implanted in the fetal heart, while the power supply (energy component) is positioned in the maternal abdominal wall. This segmentation allows each component to be optimized for its specific location, with the fetal component being small enough for the chest cavity and the maternal component having adequate space for battery capacity.
Solution Approach 2:
The invention resolves the size constraint by moving the power supply to a different spatial dimension - from the three-dimensional constraint of the fetal chest cavity to the two-dimensional surface of the maternal abdominal wall. This dimensional transition allows the power supply to be positioned where space is abundant, while the critical stimulation component remains in the constrained fetal environment.
Data Source
AI summary
The present invention provides a fully intrathoracic artificial pacemaker. The pacemaker is of sufficiently compact size to allow for implantation of both the electrode and the power source within the chest cavity. In exemplary embodiments, a screw-type electrode is used for connection to heart tissue, and a relatively short lead is used to connect the electrode to a battery unit, which can comprise electronics for control of the pacemaker. An assembly for implanting the pacemaker, as well as methods of implanting the pacemaker, are disclosed. In embodiments, the device is designed as a fetal pacemaker.