Electroanatomic Mapping for Puncture Location Identification
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Solution Overview
Problem
In cardiovascular procedures, dilating a puncture in the wrong anatomical space can lead to serious complications like hemopericardium, and existing methods such as pressure readings and contrast injection are unreliable or harmful, especially for wire-based puncture devices without a lumen.
Innovation Solution
A method using an elongate puncture device with an electroanatomic mapping system to evaluate and identify the anatomical space, allowing for safe dilation by advancing a dilator over the puncture device once the correct space is confirmed, utilizing a wire, microcatheter, or needle with electrodes for electrical connection and 3D visualization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If pressure readings or contrast injection are used to identify puncture location, then the anatomical space can be identified, but the method is unreliable or harmful especially for wire-based devices without a lumen
Solution Approach 1:
The patent replaces mechanical pressure measurement systems and contrast injection methods with an electroanatomic mapping system that uses electrical signals to identify anatomical spaces. The mapping system records electrical potentials and generates 3D visualizations, eliminating the need for lumens in the puncture device while providing reliable and accurate identification of the anatomical space.
Solution Approach 2:
The puncture device is integrated with electrodes that enable it to perform multiple functions: mechanical puncturing and electrical signal recording for electroanatomic mapping. This multi-functionality allows wire-based devices without lumens to reliably identify anatomical spaces through electrical characteristics rather than relying on pressure readings or contrast injection.
2Measurement precision
If pressure readings are used to identify puncture location, then anatomical space can be identified, but the method is prone to error with movement
Solution Approach 1:
The patent replaces the mechanical pressure transducer system with an electroanatomic mapping system that records electrical potentials. Electrical signals are inherently more stable and less susceptible to movement artifacts compared to pressure readings, providing consistent and reliable anatomical space identification even during patient movement or procedural manipulation.
3Loss of information
If contrast is used to identify anatomical space, then the space can be visualized, but contrast may be harmful to patients with renal disease
Solution Approach 1:
The patent replaces contrast injection with electroanatomic mapping that visualizes anatomical spaces through electrical potential recordings and 3D graphical representations. This eliminates the need for nephrotoxic contrast media while providing comprehensive anatomical space identification and visualization, making the procedure safe for patients with renal disease.
4Adaptability or versatility
If wire-based puncture devices are used, then the procedure can be performed, but traditional identification methods are not feasible
Solution Approach 1:
The patent integrates electrodes directly into the wire-based puncture device, enabling it to perform both mechanical puncturing and electrical signal recording. This multi-functionality allows the device to work with electroanatomic mapping systems, providing accurate anatomical space identification without requiring a lumen, thus maintaining versatility while achieving measurement precision.
Solution Approach 2:
The patent combines the puncture function and electrical signal recording function into a single integrated wire-based device. The electrodes are incorporated into the device structure, allowing simultaneous mechanical access and electrical mapping, thereby enabling anatomical space identification with wire-based devices that previously lacked this capability.
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 accurate identification of the anatomical space and safe dilation, reducing the risk of complications by integrating anatomical and physiological characteristics with electroanatomic mapping, even in cases where traditional methods are not feasible.
Implementation Method 1
evaluating a shape of the anatomical space using the elongate puncture device
Data Source
AI summary
A method and apparatus are disclosed for puncturing and using the puncturing device to evaluate and identify the anatomical space that the puncturing device has entered. The physician can then determine if the puncturing device has entered the desired anatomical space or an unintended anatomical space.