Leadless Intracardiac Device for Adaptive Ventricular Pacing
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Solution Overview
Problem
Current 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 ability to provide adaptive ventricle-from-atrium pacing with optimal atrioventricular delays without monitoring the right ventricle's electrical activity.
Innovation Solution
An implantable medical device with a tissue-piercing electrode and a right atrial electrode, along with a controller that calibrates pacing therapy based on measured physiological responses, including heart rate and AV delays, to deliver adaptive ventricle-from-atrium cardiac therapy without relying on monitored electrical activity from the right ventricle, allowing for optimal pacing delays and therapy delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If transvenous leads are used for cardiac therapy, then device stability and reliability are improved, but device complexity and ease of operation deteriorate
Solution Approach 1:
The patent extracts and eliminates the transvenous lead component entirely, achieving cardiac therapy through a leadless intracardiac device implanted directly in the right ventricle. This removes the complexity of lead insertion and positioning while maintaining therapeutic effectiveness through direct ventricular electrode contact.
Solution Approach 2:
Instead of inserting leads through veins into the heart (conventional approach), the patent inverts the approach by implanting a self-contained device directly into the right ventricle. The device uses the ventricular wall itself as an anchor, eliminating the need for transvenous leads and reversing the traditional insertion pathway.
2Ease of operation
If conventional pacemakers are used, then ease of operation is improved, but adaptability deteriorates
Solution Approach 1:
The patent implements dynamic adaptability by automatically adjusting pacing parameters based on real-time physiological feedback. The device monitors heart rate, AV delay, and other cardiac parameters, then dynamically modifies pacing timing and intensity to optimize cardiac synchrony and output, transitioning from static to adaptive operation.
Solution Approach 2:
The device incorporates feedback mechanisms that continuously monitor cardiac electrical activity, mechanical response, and physiological parameters. This feedback loops back to the control circuitry, enabling automatic adjustment of pacing therapy to match the patient's real-time cardiac state, thereby achieving adaptability without compromising ease of use.
3Productivity
If adaptive pacing therapy is implemented, then productivity and cardiac efficiency are improved, but device complexity increases
Solution Approach 1:
The device performs self-service by automatically adjusting its own pacing parameters based on monitored physiological responses. The control circuitry independently analyzes cardiac electrical signals, determines optimal AV delays, and modifies pacing therapy without external intervention, achieving adaptive cardiac efficiency through autonomous operation.
Solution Approach 2:
The patent changes key pacing parameters dynamically, including AV delay, pacing rate, and pulse intensity, based on real-time cardiac conditions. By continuously adjusting these parameters to optimize cardiac synchrony and output, the device achieves improved productivity while managing complexity through algorithmic control of parameter modulation.
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
Enables more precise and adaptive cardiac pacing therapy, improving cardiac synchrony and efficiency by determining optimal pacing delays for various heart rates, thereby enhancing cardiac output and addressing arrhythmias without the need for transvenous leads.
Implementation Method 1
a tissue-piercing electrode implantable through the right atrial endocardium and central fibrous body to deliver cardiac therapy to, or sense electrical activity of, the left ventricle
Implementation Method 2
to deliver cardiac therapy to, or sense electrical activity of, the right atrium of a patient's heart
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 left ventricular myocardium of the patient's heart from 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. A separate medical device may be used to provide some functionality for cardiac therapy. The implantable medical device or separate medical device may be used to measure physiological response information, such as cardiac electrical heterogeneity information. The physiological response information may be used to calibrate and deliver adaptive pacing therapy.