Flexible Intercostal Pacemaker Generator for Leadless Implantation
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Solution Overview
Problem
Conventional cardiac pacemakers face challenges such as infection, lead dislodgement, and inappropriate shocks due to the need for transvenous leads, which can interfere with heart function and are not suitable for all patients, particularly those with compromised venous access or heart conditions like atrial fibrillation.
Innovation Solution
A leadless pacemaker system with a flexible, miniature generator implanted in the intercostal space, capable of wireless recharging and equipped with piezoelectric crystals for mechanical sensing, Doppler blood flow detection, and ultrasonic stimulation, operates based on an algorithm that considers electrical, mechanical, and blood flow data to prevent inappropriate shocks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If transvenous leads are used in conventional pacemakers, then electrical pacing function is achieved, but risk of infection and lead dislodgement increases
Solution Approach 1:
The patent removes the transvenous leads from the pacemaker system, extracting the harmful component while retaining the essential pacing function. The generator is implanted subcutaneously in the intercostal space without requiring venous access or intracardiac lead placement, thereby eliminating infection and lead dislodgement risks associated with transvenous approaches.
Solution Approach 2:
The patent introduces an intermediary approach by using a subcutaneous generator with external or transcutaneous leadless electrodes that couple to the heart through body tissues rather than requiring direct venous and intracardiac placement. This intermediary configuration maintains pacing functionality while avoiding the harmful effects of transvenous leads.
2Ease of operation
If transvenous leads are implanted, then cardiac pacing is enabled, but interference with chest wall and ribs motion occurs
Solution Approach 1:
The patent extracts the leads from the transvenous route and places the generator in the intercostal space, removing the source of interference with chest wall and ribs motion. The flexible generator can accommodate normal physiological movements without causing discomfort or functional interference.
Solution Approach 2:
The patent employs a flexible generator housing that can bend and move with the chest wall and ribs during respiration and body motion. This flexibility allows the device to conform to the dynamic anatomy of the intercostal space without restricting or interfering with normal chest wall motion.
3Reliability
If conventional disc-shaped generators are used, then pacemaker function is provided, but interference from lung tissue and ribs occurs
Solution Approach 1:
The patent transitions from a conventional disc-shaped generator to a curved, elongated flexible generator that conforms to the anatomical curvature of the intercostal space. This curved configuration optimizes the positioning of electrodes relative to the heart, improving signal quality by minimizing interference from lung tissue and ribs while maintaining reliable pacemaker function.
4Adaptability or versatility
If the generator is made flexible for intercostal implantation, then adaptability to intercostal space is improved, but device complexity increases
Solution Approach 1:
The patent uses flexible printed circuit boards and flexible housing materials to create a generator that can bend and conform to the intercostal space. These flexible components are engineered to provide the necessary adaptability while maintaining structural integrity and electrical functionality, managing the complexity through specialized materials and construction techniques.
Solution Approach 2:
The flexible generator design integrates multiple functions including pacing, sensing, and wireless communication within a single adaptable device. The universal design allows the same flexible generator to accommodate variations in patient anatomy and provide comprehensive cardiac management functionality, reducing the need for additional specialized components.
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 system provides effective pacing and defibrillation without the need for transvenous leads, reducing the risk of complications and improving patient safety by accurately diagnosing life-threatening rhythms and minimizing unnecessary shocks.
Implementation Method 1
equipped with piezoelectric crystals for mechanical sensing
Implementation Method 2
Doppler blood flow detection
Implementation Method 3
ultrasonic stimulation
Implementation Method 4
rechargeable from a power source external to the chest wall through inductive charging to wirelessly transfer energy from the power source to replete the generator's battery
Data Source
AI summary
A pacemaker system is configured to sense electrical and mechanical activity of the heart tissue within a mammalian body and to generate a corresponding signal responsive to the sensed cardiac activity. The system includes a flexible electrical generator that contains EKG (ECG) electrodes for measuring electrical activity and ECHO piezoelectric electrodes for measuring mechanical activity of the heart and Doppler blood flow. The generator is embedded in a flexible shield, and is contoured to conform to the anatomy of the intercostal space to be embedded between the ribs of a patient and in the position overlying the heart. The system provides for pacing as well as defibrillation, responsive to the readings of the heart activities. A microprocessor analyzes a cardiac situation, based on the sensor's readings, produces a diagnosis, and generates control signals, such as “pacing pulse” in a life-threatening situation, or “observe” in a non life-threatening situation.