Aorta-Left Atrium Puncture Device Using Radiofrequency Energy
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Solution Overview
Problem
Current methods for creating a communication pathway between the aorta and the left atrium, such as those used in LVADs, face limitations like effusions, valve stenosis, hematoma, and vessel dissection due to the need to traverse the mitral and aortic valves and ventricle.
Innovation Solution
A method and device that use a puncture assembly with a sheath, dilator, and atraumatic radiofrequency guidewire to create a direct pathway between the aorta and left atrium by advancing a perforating tip through the interatrial septum, avoiding the mitral and aortic valves, and using radiofrequency energy to puncture the tissue, allowing for the deployment of therapeutic devices like shunts or stents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional LVAD catheter is tracked from the LA through the mitral valve to the LV through the aortic valve to the aorta, then the pathway can be established, but complications such as effusions, valve stenosis, hematoma, and vessel dissection occur
Solution Approach 1:
The invention extracts and eliminates the need to traverse the mitral and aortic valves by creating a direct puncture pathway from the left atrium to the aorta. The puncture device directly penetrates the aortic wall adjacent to the left atrium, removing the intermediate valve-crossing steps that cause complications.
Solution Approach 2:
Instead of approaching the aorta from the left ventricle through the aortic valve (conventional method), the invention inverts the approach by puncturing directly from the left atrium through the aortic wall. This reverse pathway eliminates exposure to the mitral and aortic valves entirely.
2Reliability
If multiple device exchanges are performed during pathway creation, then the pathway can be established, but procedural complexity and complications increase
Solution Approach 1:
The invention merges multiple functions into a single integrated puncture device assembly that includes the puncture needle, guidewire, and catheter delivery system. This unified design allows the entire pathway creation and device delivery process to be accomplished without exchanging between multiple separate devices.
Solution Approach 2:
The puncture device is designed with multi-functionality, serving as both the puncture instrument and the delivery system for the LVAD catheter. The single device performs穿刺, guidewire functions, and catheter delivery, eliminating the need for sequential device exchanges.
3Object-affected harmful factors
If a direct puncture pathway from LA to aorta is created, then complications are reduced, but precise navigation and positioning are required
Solution Approach 1:
The invention replaces mechanical navigation and positioning methods with imaging-guided navigation. Fluoroscopy and echocardiography provide real-time visualization to guide the puncture device to the precise target site on the aortic wall adjacent to the left atrium, eliminating the need for complex mechanical positioning systems.
Solution Approach 2:
The invention introduces imaging modalities (fluoroscopy, echocardiography) as intermediaries to facilitate accurate positioning. These imaging systems serve as mediators between the operator and the target site, providing visual feedback for precise needle placement without requiring direct mechanical measurement or palpation.
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 reduces complications by minimizing device exchanges, navigating tortuous anatomy, and providing a stable platform for therapeutic device delivery, thereby enhancing procedural efficiency and reducing risks like effusions and hematoma.
Implementation Method 1
the perforating tip comprises a radiofrequency perforation electrode, and step g. comprises delivering radiofrequency energy from the radiofrequency perforation electrode while advancing the perforating tip
Data Source
AI summary
Methods and devices are disclosed for the formation of a communication between the aorta and left atrium. The method includes introducing a puncturing device, positioning the device at a location along the aorta, and advancing the puncturing device to create a pathway. The method may include: a. via an inferior artery, advancing a perforating tip of the puncturing device towards the aorta; b. positioning the perforating tip adjacent a wall of the aorta, proximate the left atrium; and c. advancing the perforating tip to perforate through the wall of the aorta and then through a wall of the left atrium, to create a pathway between the aorta and the left atrium, wherein the creation of the pathway can be confirmed with at least one of fluoroscopy, electro-anatomical mapping, pressure measurement, contrast injection, and echocardiograph.