Leadless Myocardial Stimulation With Wireless Defibrillation Coordination
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Solution Overview
Problem
Conventional cardiac contractility modulation (CCM) devices pose risks due to bipolar leads affecting blood flow and valve closure, incorrect delivery timing of electrical impulses, and inability to treat patients with premature ventricular contractions or ventricular tachycardia, often requiring patients to choose between CCM and ICD therapies, and S-ICDs provide limited therapeutic value.
Innovation Solution
A cardiac therapy apparatus with a subcutaneous defibrillation assembly and leadless myocardial stimulation assembly, utilizing wireless communication to detect global and local activation events, determine appropriate impulse delivery times, and apply electrical stimulation impulses during the absolute refractory period to enhance myocardial contractility and adjust heart rate.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If bipolar leads are implanted in the ventricular septum for conventional CCM therapy, then electrical stimulation can be delivered to enhance myocardial contractility, but the leads affect normal blood flow and valve closure and may fall off causing infection
Solution Approach 1:
The patent removes the bipolar leads from the ventricular septum and extracts only the essential function of electrical stimulation. The leadless myocardial stimulation assembly delivers electrical impulses directly to the myocardium without requiring intracardiac leads, thereby eliminating the harmful effects of leads on blood flow and valve closure while maintaining the therapeutic benefit of enhanced myocardial contractility.
Solution Approach 2:
The patent introduces a subcutaneous defibrillation assembly as an intermediary device that wirelessly communicates with the leadless myocardial stimulation assembly. This intermediary system enables remote monitoring and control of CCM therapy parameters, allowing for safe and effective delivery of electrical stimulation without direct lead contact with the heart structures.
2Reliability
If electrical impulse stimulus is delivered based on local cardiac muscle electrical signals, then myocardial contractility can be enhanced, but the delivery timing may be incorrect leading to ventricular tachycardia or fibrillation
Solution Approach 1:
The patent implements a feedback mechanism where the subcutaneous defibrillation assembly continuously monitors global cardiac electrical activity and provides real-time information to the leadless myocardial stimulation assembly. This feedback loop ensures that electrical impulses are delivered at the correct timing relative to the cardiac cycle, preventing stimulation during vulnerable periods that could trigger ventricular tachycardia or fibrillation.
Solution Approach 2:
The system performs preliminary detection of cardiac electrical events through the subcutaneous defibrillation assembly before delivering electrical stimulation. By anticipating the appropriate timing window for safe stimulation based on pre-detected electrical signals, the system ensures that impulses are delivered only during safe periods of the cardiac cycle, avoiding arrhythmogenic effects.
3Adaptability or versatility
If stimulation electrodes are arranged in the ventricular septum to avoid far-field stimulation, then local contractility enhancement is achieved, but the device cannot be used at other positions for enhanced contractility
Solution Approach 1:
The patent employs a dynamic and flexible leadless myocardial stimulation assembly that can be positioned at various locations on the myocardial surface. The device incorporates adjustable electrode configurations and programmable stimulation patterns that adapt to different anatomical positions and clinical requirements, enabling versatile placement while maintaining precise local stimulation through controlled electrical field geometry.
4Adaptability or versatility
If conventional CCM devices are used for heart failure treatment, then myocardial contractility is enhanced, but patients with premature ventricular contractions or ventricular tachycardia cannot receive treatment
Solution Approach 1:
The patent creates a universal cardiac therapy system that combines both CCM and defibrillation functions in an integrated platform. The leadless myocardial stimulation assembly can deliver contractility-enhancing electrical impulses, while the subcutaneous defibrillation assembly provides life-saving defibrillation capability. This multi-functional system can safely treat a broad spectrum of patients including those with arrhythmias, eliminating the need to choose between CCM and ICD therapies.
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 apparatus effectively enhances myocardial contractility and provides defibrillation, reducing risks associated with conventional CCM devices and addressing the limitations of S-ICDs, offering a comprehensive treatment for heart failure patients.
Implementation Method 1
detect a local activation event of myocardium at a predetermined stimulation position... generate a local sense signal indicative of the local activation event
Implementation Method 2
detect a global activation event of the heart... generate a far-field sense signal indicative of the global activation event
Implementation Method 3
apply to the predetermined stimulation position an electrical stimulation impulse for enhancing the contractility of myocardial cells
Implementation Method 4
deliver a defibrillation wave to treat malignant arrhythmia
Data Source
Figure 1
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Figure 3A~3C
AI summary
The present application relates to a cardiac therapy apparatus. The cardiac therapy apparatus comprises: a subcutaneous defibrillation assembly, which comprises a first control component and is configured to sense a global activation event of a heart, generate a far-field sense signal indicative of the global activation event, and deliver a defibrillation wave to a patient when the patient has malignant arrhythmia; and a leadless myocardial stimulation assembly, which comprises a second control component and is configured to sense a local activation event of myocardium at a predetermined stimulation position, generate a local sense signal indicative of the local activation event, and apply to the predetermined stimulation position an electrical stimulation impulse for enhancing the myocardial contractility, wherein the first control component is coupled to the second control component through wireless communication, and the first control component and/or the second control component are/is configured to determine, at least according to the far-field sense signal and the local sense signal, whether to apply the electrical stimulation impulse to the predetermined stimulation position.