Subcutaneous ICD Pulse Generator and Electrode Segments
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Solution Overview
Problem
Current subcutaneous implantable cardioverter-defibrillators (S-ICDs) face challenges in providing sufficient energy for defibrillation due to large canister sizes and complications associated with transvenous ICDs, such as hemopericardium, hemothorax, and lead malfunctions.
Innovation Solution
The development of a subcutaneous implantable medical system with a pulse generator positioned submuscularly and leads having multiple electrode segments, including a common lead coil that extends from the anterior to the posterior of the chest, providing electrical shocks for antiarrhythmic therapy with a defibrillation threshold of at most 50 Joules and a pulse generator volume of at most 40 milliliters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Use of energy by moving object
If a subcutaneous ICD uses a large canister to provide sufficient energy for defibrillation, then the energy capacity is improved, but the device size and invasiveness worsen
Solution Approach 1:
The lead is divided into multiple electrode segments (first electrode segment, second electrode segment, and shock coil) that can be positioned at different locations along the chest wall. This segmentation allows the system to distribute the energy delivery function across multiple smaller components rather than requiring a single large canister, thereby reducing the pulse generator volume while maintaining sufficient defibrillation energy capacity
Solution Approach 2:
The electrode segments are positioned in a distributed three-dimensional arrangement along the chest wall (anterior to posterior, lateral to medial) rather than concentrating all functionality in a single location. This spatial distribution enables the system to achieve adequate energy delivery through the combined effect of multiple smaller electrodes positioned at optimal locations for current flow through the heart
2Use of energy by moving object
If transvenous ICDs are used to provide defibrillation therapy, then the energy delivery capability is improved, but the risk of complications worsens
Solution Approach 1:
The system extracts the leads from the venous system and places them entirely in the subcutaneous space, eliminating the need for venous puncture and intracardiac lead placement. This removes the source of many complications (venous occlusion, lead dislodgement, endocardial infection, hemopericardium) while preserving the defibrillation energy delivery capability through the subcutaneous electrode segments
Solution Approach 2:
The subcutaneous tissue serves as an intermediary medium for energy delivery, replacing the need for venous access and direct cardiac contact. The electrode segments deliver energy through the subcutaneous tissue to the underlying heart, providing a safer pathway that avoids the harmful complications associated with transvenous access while maintaining therapeutic effectiveness
3Device complexity
If multiple electrode segments are positioned subcutaneously to reduce invasiveness, then the procedural complexity is reduced, but the difficulty of achieving sufficient energy delivery worsens
Solution Approach 1:
Each electrode segment is positioned at a specific location with optimized local characteristics (first electrode segment along anterior chest, second electrode segment along lateral/posterior chest, shock coil at appropriate depth) to maximize current flow through the heart. This localized optimization ensures that each segment contributes effectively to energy delivery, achieving sufficient defibrillation capability through the coordinated action of multiple simpler, locally-optimized components
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This configuration allows for effective antiarrhythmic therapy with reduced invasiveness and complexity, minimizing complications by providing sufficient energy for defibrillation while being less bulky and less invasive compared to traditional S-ICDs.
Implementation Method 1
The first and second electrode segments are positioned subcutaneously at or below an apex of a heart of the patient, wherein the PG electrode and the first and second electrode segments are configured to provide electrical shocks for antiarrhythmic therapy
Data Source
AI summary
Methods for implanting a pulse generator (PG) within a pectoral region of a chest of a patient and devices having the PG. The PG has a housing that includes a PG electrode. Methods also include implanting at least one lead having first and second electrode segments with the first electrode segment positioned along an anterior of the chest of the patient and the second electrode segment positioned along at least one of a posterior of the patient or a side of the patient. The first and second electrode segments are positioned subcutaneously at or below an apex of a heart of the patient, wherein the PG electrode and the first and second electrode segments are configured to provide electrical shocks for antiarrhythmic therapy.