Insert Molded Shroud for Implantable Cardiac Electrodes
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing ECG systems rely on external electrodes, which suffer from signal quality issues due to interference, patient discomfort, and mechanical problems, limiting the accuracy of cardiac activity monitoring.
Innovation Solution
A leadless subcutaneous electrode array with a compliant shroud and planar electrodes coupled to IMD circuitry, capable of detecting cardiac activity and transmitting signals without external electrodes, using biocompatible materials and optimized electrode configurations for improved signal quality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If external electrodes are used for ECG monitoring, then the system can detect cardiac activity, but signal quality deteriorates due to interference, patient discomfort, and mechanical problems
Solution Approach 1:
The invention extracts the electrodes from the external environment and relocates them to an implantable configuration. The shroud with electrodes is implanted subcutaneously, removing the electrodes from external contact with the environment that causes interference and discomfort, while maintaining the ability to detect cardiac electrical activity
Solution Approach 2:
The shroud acts as an intermediary structure that holds the electrodes in a fixed, stable position relative to the heart. This intermediary framework eliminates the mechanical instability and movement artifacts associated with external electrodes, providing stable electrical contact for high-quality signal detection
2Ease of operation
If external electrodes and leads are used for ECG recording, then cardiac activity can be monitored, but the system complexity and patient discomfort increase
Solution Approach 1:
The invention merges the electrodes, shroud structure, and lead connections into a single integrated implantable assembly. This combination eliminates the need for separate external electrodes and leads, reducing the overall system complexity while improving patient comfort through a minimally invasive implant procedure
Solution Approach 2:
Instead of having electrodes on the skin surface connected to external equipment, the invention inverts the approach by placing the electrodes and processing circuitry inside the body. This inversion moves the complex components from the external environment to an internal implant, eliminating the need for external lead connections and improving patient comfort
3Measurement precision
If surface electrodes are used for ECG analysis, then the system can detect PQRST waves, but measurement precision is limited by external interference
Solution Approach 1:
The shroud provides a localized stable environment for the electrodes, positioning them in optimal locations relative to the heart for detecting PQRST waves. The structured support ensures each electrode maintains its intended spatial relationship to cardiac structures, improving the accuracy of wave detection and analysis
Data Source
AI summary
Apparatus and method for fabricating a shroud member having extra-cardiac sensing electrode. The assembly is used to provide a subcutaneous cardiac activity sensing device via at least a pair of electrodes mechanically coupled to the shroud member. In one embodiment only a major surface portion of the electrodes are exposed to body fluid and tissue. One beneficial aspect of the fabrication techniques herein involve the encapsulation of the elongated conductors and a majority of the electrode surfaces thereby reducing possibility for electrical shorting among the IMD housing and the other conductive members. The assemblies provided can be fabricated efficiently, inexpensively, quickly and easily using insert-molding techniques.