Electro-Anatomical Model for His Bundle Pacing Training
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Solution Overview
Problem
Current cardiac resynchronization therapy (CRT) techniques face challenges in pacing the His bundle due to its small size and weak electrical signal, making it difficult to locate and affix pacing leads, leading to lengthy implantation procedures and inadequate training models that fail to accurately represent human anatomy.
Innovation Solution
An electro-anatomical model with an anatomically accurate representation of the heart, including a conductive insert simulating the His bundle, allows for the fixation of leads and simulates electrical signals, facilitating the development of tools and training for His pacing by mimicking the human heart's anatomy and electrical properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional CRT pacing is used with myocardial stimulation, then ventricular pacing can be achieved, but abnormal electrical activation sequences occur resulting in mechanical ventricular dyssynchrony and increased risk of heart failure
Solution Approach 1:
The patent creates a photorealistic 3D model that accurately copies human cardiac anatomy including the His bundle, allowing developers to test and optimize pacing techniques without performing procedures on actual patients. This virtual copying enables safe experimentation with His bundle pacing approaches that can later be translated to clinical practice
Solution Approach 2:
The patent introduces an intermediary training model that mediates between theoretical knowledge and actual clinical practice. The photorealistic 3D model serves as a bridge, allowing users to practice His bundle pacing techniques in a realistic yet risk-free environment before applying them to real patients
2Reliability
If His bundle pacing is used to achieve physiologically natural ventricular pacing, then mechanical ventricular dyssynchrony is reduced, but the procedure becomes difficult to perform due to the small size and weak electrical signal of the bundle of His
Solution Approach 1:
The photorealistic 3D model creates a visual copy of the His bundle with realistic appearance and electrical characteristics, making it visible and detectable during training procedures. This copying allows users to practice lead placement and signal detection without the difficulty of working with the actual tiny human His bundle
Solution Approach 2:
The patent enables preliminary practice and skill development in the virtual 3D environment before actual clinical procedures. Users can perform repeated trials of His bundle localization and lead affixing in the model, gaining competence before facing the real procedure's challenges
3Manufacturing precision
If animal models such as pigs or dogs are used for developing His pacing tools and training, then anatomically appropriate models are available, but expense and significant anatomic and physiologic differences from humans limit their use
Solution Approach 1:
Instead of using animal models, the patent creates a photorealistic 3D copy of human cardiac anatomy. This virtual model accurately reproduces human His bundle structure and electrical properties without the anatomical differences that plague animal models, providing direct applicability to human medicine
Solution Approach 2:
The patent replaces expensive animal models with a cost-effective virtual 3D model. The photorealistic simulation provides unlimited reuse at minimal cost, eliminating the expense and ethical concerns associated with animal experimentation while maintaining high anatomical accuracy
4Reliability
If the bundle of His is located and a pacing lead is affixed to it, then His bundle pacing can be achieved, but the procedure takes lengthy time due to the difficulties involved in location and affixing
Solution Approach 1:
The patent enables preliminary practice of the entire His bundle pacing procedure including localization and lead affixing in the virtual 3D model. Users can rehearse and optimize their technique beforehand, reducing the time required during actual clinical procedures
Solution Approach 2:
The photorealistic 3D model provides visual and electrical feedback during the simulation, allowing users to immediately see the results of their actions and adjust their technique. This real-time feedback accelerates learning and improves procedural efficiency in subsequent real-world applications
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 model enables precise simulation of His bundle pacing, reducing procedural complexity and improving training efficiency by providing a realistic and cost-effective means to locate and implant pacing leads, thereby enhancing the effectiveness of CRT.
Implementation Method 1
a circuit providing electrical signals to the plug to simulate electrical signals generated by the bundle of His/Purkinje system in vivo
Implementation Method 2
The insert allows fixation of at least one lead and, in one embodiment, has physical and/or electrical properties that simulate myocardial tissue
Data Source
AI summary
An electro-anatomical model of the mammalian His/Purkinje system includes a shell simulating the anatomy of at least a portion of a mammalian heart. The shell has a hollow interior and a first port providing an aperture to the interior of the shell. A plug is inserted in the first port so that a surface of the plug is exposed to the interior of the shell. An electrical circuit provides signals to electrodes in the plug which simulate the electrical signals generated by the bundle of His/Purkinje system in vivo. A second port provides access to the interior of the shell for an introducer catheter to locate the simulated bundle of His and to insert a pacing lead therein. The model is useful for developing tools for His pacing and for training users in techniques for implanting His pacing leads.