Leadless Cardiac Pacing via Acoustic Energy Transmission
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Solution Overview
Problem
Conventional cardiac pacing systems relying on lead/wire technology face complications such as infection, dislodgement, and limited access to optimal pacing sites, particularly for left ventricular stimulation, which restricts effective hemodynamic benefits and arrhythmia termination in post-cardiac surgery patients.
Innovation Solution
The use of acoustic energy to transmit energy and signal information from an external device to an implanted leadless receiver-stimulator, allowing for direct electrical stimulation of cardiac muscle without the need for leads, with the ability to select precise pacing sites and provide multisite stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If lead/wire systems are used for cardiac pacing, then electrical stimulation can be delivered to the heart, but complications such as infection, lead failure, and electrode dislodgement occur
Solution Approach 1:
The patent extracts and removes the lead/wire component from the pacing system, delivering electrical stimulation directly through an implantable pulse generator positioned in the heart chamber. This eliminates the interface between external leads and body tissues, thereby preventing infections and lead-related complications while maintaining effective cardiac stimulation
Solution Approach 2:
The patent introduces a biocompatible encapsulation layer as an intermediary between the electronic components and the cardiac tissue. This encapsulation serves as a protective barrier that prevents tissue ingrowth and infection while allowing efficient electrical signal transmission to the heart muscle
2Adaptability or versatility
If multiple leads are placed for multi-site stimulation, then more pacing sites can be accessed, but the number of protruding wires increases, thus increasing complication risks
Solution Approach 1:
The patent designs a single implantable pulse generator that can deliver electrical stimulation to multiple heart chambers and tissue sites simultaneously or sequentially. This multi-functional device eliminates the need for multiple separate leads, reducing complication risks while maintaining the versatility to perform various pacing functions including atrial, ventricular, and biventricular stimulation
Solution Approach 2:
The patent combines multiple stimulation functions and electrode contacts into a single integrated implantable device. By merging the pulse generator and multiple electrode arrays into one unit implanted within the heart, the system achieves multi-site stimulation capability without requiring multiple external lead wires, thereby reducing infection risks and procedural complexity
3Ease of operation
If arterial access is used for lead placement, then pacing can be achieved, but increased risks of thrombus, thromboemboli, and embolization occur
Solution Approach 1:
The patent removes the need for arterial or venous lead insertion by positioning the pulse generator directly within the heart chamber. This eliminates the access pathway through the vascular system, thereby preventing thrombus formation, embolization, and other vascular complications associated with lead wire insertion while maintaining effective cardiac pacing
4Duration of action of moving object
If temporary pacing wires are used, then acute heart stimulation can be provided, but the insertion/exit site must be kept sterile and wires must be removed after stabilization
Solution Approach 1:
The patent employs a temporary implantable pulse generator designed for short-term use in acute settings. The device is implanted minimally invasively without requiring external lead wires that need sterile site maintenance. After providing necessary acute cardiac support, the device is removed through a simple procedure, eliminating the need for prolonged sterile site care and complex wire removal associated with traditional temporary pacing
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 approach eliminates the risks associated with lead placement, enables precise and effective stimulation of cardiac tissue, improving hemodynamics and arrhythmia management, and allows for more physiological pacing, potentially reducing the need for high-energy shocks and enhancing treatment outcomes for heart failure and arrhythmias.
Implementation Method 1
The use of acoustic energy to transmit energy and signal information from an external device to an implanted leadless receiver-stimulator, allowing for direct electrical stimulation of cardiac muscle
Data Source
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AI summary
Systems including an implantable receiver-stimulator and an external controller-transmitter system are used for leadless acute stimulation of the heart, particularly after heart surgery. Cardiac pacing and arrhythmia control is accomplished with one or more implantable receiver-stimulators and an external system that alternatively includes the use of an external pacemaker. Receiver-stimulators are implanted in the heart during surgery or during an acute interventional procedure and then a triggered for stimulation by using the external system. In one embodiment of these systems, a controller-transmitter is activated by an external pacemaker to time the delivery of acoustic energy transmission through the body to a receiver-stimulator at a target tissue location. The receiver-stimulator converts the acoustic energy to electrical energy for electrical stimulation of the heart tissue.