Leadless AV Synchronous Cardiac Therapy via Tissue-Piercing Electrode
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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 and central fibrous body 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 processing circuitry for monitoring and therapy delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If transvenous leads are used for cardiac therapy delivery, then reliable electrical connection is achieved, but device complexity and surgical risk increase
Solution Approach 1:
The patent extracts and eliminates the transvenous lead system from the cardiac therapy device. The leadless pacemaker is implanted directly into the right ventricle, removing the need for venous access, lead wires, and subcutaneous pulse generator connections, thereby reducing device complexity while maintaining therapeutic reliability
Solution Approach 2:
The patent combines the pulse generator, battery, and electrode functions into a single integrated leadless device. This merging of previously separate components (pulse generator + leads + electrodes) into one implantable unit reduces overall system complexity while ensuring reliable electrical connection through direct myocardial contact
2Device complexity
If single chamber pacing is used, then device simplicity is maintained, but ventricular synchronization capability is insufficient
Solution Approach 1:
The patent implements dynamic pacing capabilities within a single-chamber device. The pacemaker can adaptively adjust pacing parameters, deliver biventricular pacing when needed, and provide cardioversion/defibrillation therapies, transforming a static single-chamber device into a dynamic multi-functional system that addresses varying ventricular synchronization needs
Solution Approach 2:
The leadless device is designed with universal functionality to perform multiple cardiac therapies including single and dual chamber pacing, cardioversion, and defibrillation. This multi-functionality allows the device to adapt to different clinical scenarios and provide comprehensive ventricular synchronization without requiring separate specialized devices
3Productivity
If AV synchronous pacing is implemented, then cardiac efficiency is improved, but device complexity increases
Solution Approach 1:
The pacemaker incorporates intrinsic sensing capabilities that automatically detect atrial and ventricular electrical activity without external intervention. The device self-regulates pacing timing based on sensed cardiac events, providing AV synchronous pacing that improves cardiac efficiency while minimizing the complexity of external control systems
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
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
Data Source
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.