Aortic Puncture Device for Left Atrial Access
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Solution Overview
Problem
Current methods for creating a connection between the left atrium and the aorta, such as for implanting LVADs, often result in complications like effusions, valve stenosis, and hematoma due to invasive procedures, necessitating a less invasive and more efficient method for establishing fluid communication.
Innovation Solution
A system comprising a puncturing device with an atraumatic tip, capable of delivering radiofrequency energy or having a sharp distal tip, used in conjunction with a steerable sheath and dilator to create a puncture between the aorta and left atrium, allowing for flexible use as a guidewire and reducing procedural complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional LVAD catheter tracking is performed from the left atrium through the mitral valve to the left ventricle and aorta, then blood flow support is achieved, but complications such as effusions, valve stenosis, hematoma, and vessel dissections occur
Solution Approach 1:
The patent inverts the traditional catheter tracking approach by accessing the left ventricle from the aorta rather than from the left atrium. The puncture device is advanced through the aorta, punctures the aortic wall to enter the left ventricle, and establishes an aorta-to-left ventricle communication. This reverse approach avoids traversal of the mitral valve and left atrium, thereby preventing complications such as valve stenosis, atrial effusions, and hematoma formation in those structures.
Solution Approach 2:
The patent extracts the puncture function from the traditional transatrial transvalvular pathway and creates a direct aortic-to-left ventricular access. By removing the intermediate steps of traversing the left atrium and mitral valve, the procedure eliminates the harmful effects associated with those structures while maintaining the therapeutic goal of LVAD catheter delivery.
2Ease of operation
If percutaneous LVAD pump devices are used with a shunt between the left atrium and aorta, then less invasive implantation is achieved, but a direct fluid communication pathway must be created between the left atrium and aorta
Solution Approach 1:
The patent inverts the shunt creation approach by establishing an aorta-to-left ventricle communication rather than a left atrium-to-aorta connection. The puncture device is advanced from the aorta, punctures the aortic wall to enter the left ventricle, and creates a controlled communication pathway. This inverted approach simplifies the procedure by avoiding the need to navigate and create connections through the left atrium, thereby reducing device complexity while maintaining percutaneous access benefits.
3Productivity
If a puncturing device with sharp distal tip is used to create a puncture between aorta and left atrium, then procedural efficiency is improved, but risk of tissue damage increases
Solution Approach 1:
The patent applies parameter changes by utilizing radiofrequency energy to modify the physical state of the puncture process. Instead of relying solely on mechanical sharp tip penetration, the device delivers radiofrequency energy to the tissue at the puncture site, which facilitates tissue separation and puncture creation. This energy-based approach reduces the mechanical force required and minimizes trauma to surrounding tissues while maintaining procedural efficiency.
Solution Approach 2:
The patent replaces purely mechanical puncture mechanisms with a hybrid approach incorporating radiofrequency energy delivery. The puncture device includes an RF electrode that delivers energy to the tissue, substituting part of the mechanical penetration process with thermal and electromagnetic effects. This substitution reduces the need for high mechanical forces from a sharp tip, thereby decreasing tissue damage while maintaining or improving procedural efficiency.
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 safe and efficient creation of a fluid communication pathway between the aorta and left atrium, reducing complications and enhancing procedural efficiency by minimizing invasive procedures and facilitating the use of end-therapy devices.
Implementation Method 1
capable of delivering radiofrequency energy or having a sharp distal tip
Data Source
AI summary
A method of puncturing from an aorta into a left atrium using a puncturing device. The method involves a step of accessing a carotid artery and advancing a puncturing device through the carotid artery into an aorta. Advancing a sheath and a dilator over the puncturing device through the carotid artery and into the aorta such that a puncturing tip of the puncturing device is aligned with a distal tip of the sheath and a distal tip of the dilator, forming a puncturing assembly. Positioning the puncturing assembly at a target site within the aorta to gain access to a left atrium of a heart. Tenting a tissue between the aorta and the left atrium using the puncturing assembly. Creating a puncture through the tissue by advancing the puncturing device such that a channel between the aorta and the left atrium is formed.