Tissue-Piercing Electrode for Cardiac Resynchronization
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Solution Overview
Problem
Current implantable medical devices for cardiac therapy, such as pacemakers and cardioverter-defibrillators, often require transvenous leads and may not adequately address cardiac conduction diseases or abnormalities, particularly in patients with AV dyssynchrony or tachycardia, as they lack the capability for comprehensive ventricular synchronization and tachycardia management.
Innovation Solution
An implantable medical device with a tissue-piercing electrode implanted from the triangle of Koch region of the right atrium through the right atrial endocardium to the basal and/or septal region of the left ventricular myocardium, enabling atrioventricular synchronous pacing, cardiac resynchronization, and tachycardia-related therapy without the need for transvenous leads, using a combination of electrodes and a controller for monitoring and therapy delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If transvenous leads are used for cardiac therapy delivery, then the device can provide pacing and therapy functions, but the device complexity and implantation invasiveness increase
Solution Approach 1:
The patent combines multiple functions (pacing, sensing, and therapy delivery) into a single integrated device implanted in the right ventricle. The tissue-piercing electrode integrates both sensing and stimulation capabilities, eliminating the need for separate transvenous leads and reducing overall system complexity while maintaining full therapeutic capability
Solution Approach 2:
The implantable device is designed with multi-functionality to perform both sensing and pacing/therapy delivery through the same electrode and housing components. The right atrial electrode and ventricular electrode can alternatively serve as return electrodes for pacing, providing versatile therapeutic options without requiring additional specialized leads
2Adaptability or versatility
If traditional dual chamber devices are used, then atrial and ventricular pacing can be provided, but the capability for comprehensive ventricular synchronization and tachycardia management is insufficient
Solution Approach 1:
The patent introduces a tissue-piercing electrode as an intermediary component that extends through the right ventricular wall to contact the left ventricular epicardium. This intermediary structure enables direct electrical coupling between right and left ventricles, providing effective ventricular synchronization and tachycardia management that traditional dual chamber devices cannot achieve
3Reliability
If a tissue-piercing electrode is implanted from the right atrium through the endocardium to the left ventricle, then ventricular synchronization is enhanced, but the implantation complexity increases
Solution Approach 1:
The tissue-piercing electrode is pre-formed with the appropriate geometry and electrical contacts before implantation. The electrode is designed in advance to pierce through the right ventricular wall and contact the left ventricular epicardium, eliminating the need for complex intraoperative shaping or positioning adjustments and simplifying the implantation procedure
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 solution provides effective cardiac resynchronization and tachycardia management by enhancing ventricular synchronization and addressing cardiac conduction abnormalities, improving cardiac output and rhythm regulation without the limitations of traditional transvenous lead systems.
Implementation Method 1
The plurality of electrodes includes a tissue-piercing electrode implantable from the triangle of Koch region of the right atrium through the right atrial endocardium and central fibrous body to at least one of deliver cardiac therapy to and sense electrical activity of the left ventricle
Implementation Method 2
In some cases, an IMD may sense intrinsic depolarizations of the heart, and control the delivery of therapeutic stimulation to the heart based on the sensing
Data Source
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AI summary
VfA cardiac therapy uses an implantable medical device or system. The implantable medical device includes a tissue-piercing electrode implanted in the basal and/or septal region of the left ventricular myocardium of the patient's heart from the triangle of Koch region of the right atrium through the right atrial endocardium and central fibrous body. The device may include a right atrial electrode, a right atrial motion detector, or both. The device may be implanted completely within the patient's heart or may use one or more leads to implant electrodes in the patient's heart. The device may be used to provide cardiac therapy, including single or multiple chamber pacing, atrioventricular synchronous pacing, asynchronous pacing, triggered pacing, cardiac resynchronization pacing, or tachycardia-related therapy. A separate medical device may be used to provide some functionality for cardiac therapy, such as sensing, pacing, or shock therapy.