Subcutaneous ICD with Distributed Electrodes for Minimally Invasive Implantation
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Solution Overview
Problem
Current implantable cardioverter-defibrillators (ICDs) are large and difficult to implant in certain patients, such as children and thin elderly individuals, due to their size and the need for transvenous leads, which can cause complications and are expensive to implant, especially for prophylactic use in patients at risk of sudden cardiac death.
Innovation Solution
Development of a subcutaneous implantable cardioverter-defibrillator (SubQ ICD) that can be implanted without leads in the vasculature, with various geometries and configurations to minimize trauma and cost, allowing for delivery of cardioversion/defibrillation therapy and pacing therapy, using high voltage electrodes positioned subcutaneously to cover adequate myocardial tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a full-featured ICD with transvenous leads is implanted, then comprehensive cardioversion/defibrillation and pacing therapy is provided, but device size is large and implantation is difficult in certain patients
Solution Approach 1:
The patent extracts the lead system from the ICD implantation process, creating a leadless SubQ ICD where all electrodes are positioned subcutaneously without transvenous leads. This removes the complex lead wiring while maintaining the essential defibrillation and pacing functions through subcutaneous electrode arrays that deliver therapy vectors across the heart.
Solution Approach 2:
The patent transitions from the traditional transvenous approach (moving electrodes into the heart chambers through veins) to a subcutaneous approach (positioning all electrodes outside the thoracic cavity). This dimensional change places electrodes in the subcutaneous tissue layer, creating external-to-internal therapy vectors that eliminate the need for intracardiac lead placement while maintaining therapeutic effectiveness.
2Reliability
If transvenous leads are used for ICD implantation, then cardiac electrodes can be positioned in the heart, but complications from leads in the cardiovasculature occur and cost increases
Solution Approach 1:
The patent removes the transvenous lead system entirely from the implantation procedure. All electrodes are positioned subcutaneously in the chest wall, eliminating the need for leads to traverse the venous system and enter the heart chambers. This extraction of the lead component eliminates lead-related complications such as lead fracture, dislodgement, and venous occlusion while maintaining therapeutic capability through subcutaneous electrode arrays.
3Ease of manufacture
If SubQ ICD is implanted without leads, then implantation trauma and cost are reduced, but adequate myocardial tissue coverage must be achieved
Solution Approach 1:
The patent divides the electrode system into multiple discrete subcutaneous electrodes positioned at specific locations on the chest wall. Rather than a single intracardiac electrode, multiple electrodes are distributed subcutaneously to create therapy vectors that adequately cover myocardial tissue. This segmentation allows simplified implantation while achieving reliable tissue coverage through geometric arrangement of electrodes.
Solution Approach 2:
The patent creates three-dimensional therapy vectors by positioning electrodes in the subcutaneous plane rather than within the heart chambers. This external positioning in a different anatomical dimension (subcutaneous vs. intracardiac) achieves adequate myocardial coverage by delivering shock vectors that traverse the heart from external chest wall positions, eliminating the need for intracardiac lead placement.
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
The SubQ ICD provides a cost-effective and minimally invasive option for a wide range of patients, reducing implantation challenges and complications, while offering effective cardioversion/defibrillation and pacing therapy, making it more accessible and affordable for prophylactic use.
Implementation Method 1
deliver relatively high-energy cardioversion and/or defibrillation shocks to a patient's heart when a malignant tachyarrhythmia
Implementation Method 2
stimulation for pacing in the atrial, ventricular and dual chamber
Data Source
AI summary
SubQ ICDs are disclosed that are entirely implantable subcutaneously with minimal surgical intrusion into the body of the patient and provide distributed cardioversion-defibrillation sense and stimulation electrodes for delivery of cardioversion-defibrillation shock and pacing therapies across the heart when necessary. Configurations include one hermetically sealed housing with 1 or, optionally, 2 subcutaneous sensing and cardioversion-defibrillation therapy delivery leads or alternatively, 2 hermetically sealed housings interconnected by a power/signal cable. The housings are generally dynamically configurable to adjust to varying rib structure and associated articulation of the thoracic cavity and muscles. Further the housings may optionally be flexibly adjusted for ease of implant and patient comfort.