Suprasternal Access Device for Minimally Invasive Cardiac Procedures
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Solution Overview
Problem
Current minimally-invasive heart surgery techniques for mitral valve procedures are challenging due to complex anatomy, require cardiopulmonary bypass, and involve significant trauma and complications such as bleeding and scar tissue formation, especially when accessing the left ventricle or pericardium.
Innovation Solution
A method and device that allow access to the heart through a minimally-invasive approach by inserting instruments through a suprasternal opening without penetrating the pericardium, making openings in the left atrial wall extrapericardially to perform cardiac procedures on the beating heart, avoiding cardiopulmonary bypass and reducing trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery is performed to access the heart, then complete access to the heart is achieved, but patient trauma and recovery time are significantly increased
Solution Approach 1:
The patent divides the surgical approach into separate access points: a small suprasternal incision for instrument introduction and a separate left atrial wall puncture for direct heart access. This segmentation allows complete cardiac access while avoiding the need for large sternotomy incisions and rib spreading, thereby reducing patient trauma while maintaining surgical effectiveness
Solution Approach 2:
The patent uses a pericardial window as an intermediary structure. Instruments are introduced through the suprasternal notch into the pericardial space, then the left atrial wall is punctured from within the pericardium. This intermediary approach provides complete heart access while avoiding direct external trauma to the sternum and ribs
2Object-affected harmful factors
If minimally-invasive techniques are used to reduce patient trauma, then recovery time is reduced, but access to the left ventricle becomes difficult and complicated
Solution Approach 1:
The patent employs the pericardial space as an intermediary working space that simplifies access to both the left atrium and left ventricle. By establishing instruments in the pericardium first, the surgeon gains a stable platform from which to puncture the left atrial wall and subsequently access the left ventricle, reducing the overall complexity compared to other minimally-invasive approaches
Solution Approach 2:
The patent performs preliminary establishment of instruments in the pericardial space before attempting access to the heart chambers. The suprasternal approach allows placement of guiding instruments and visualization tools in the pericardium first, which then facilitates subsequent left atrial and left ventricular access, making the overall procedure more manageable
3Ease of operation
If trans-apical approach is used to access the left ventricle, then direct access is achieved, but bleeding complications and scar tissue formation increase
Solution Approach 1:
Instead of approaching the left ventricle from the apex outward (trans-apical), the patent inverts the approach by accessing the left ventricle from within the pericardial space through the left atrial wall. This reverse approach allows controlled puncture and access while maintaining the ability to control bleeding from the puncture site, reducing bleeding complications compared to trans-apical surgery
Solution Approach 2:
The patent uses the pericardial space and left atrial wall as intermediary structures between the suprasternal incision and the left ventricle. This indirect but controlled pathway allows direct left ventricular access while enabling better control of bleeding from the puncture site compared to direct trans-apical incision into the ventricular wall
Data Source
AI summary
Systems, devices, and methods for providing access to the heart. The system includes an intracardiac access device comprising an elongate member having a channel extending between a distal end and a proximal end thereof. The intracardiac access device is configured to be advanced through an extrapericardial penetration in the left atrial wall without penetrating the pericardium of the heart. An optional procedural device is configured to be advanced through the channel of the intracardiac access device into an internal chamber of the heart and configured to perform a surgical procedure in the internal chamber of the heart. A working channel of an optional suprasternal access device is configured to facilitate access of the intracardiac access device into the body of the patient by providing a path from a suprasternal opening to a position adjacent the roof of the left atrium.