Multi-Cuspid Interatrial Shunt Geometry via Inward Septal Cutting
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Solution Overview
Problem
Existing shunting procedures for treating heart failure and pulmonary edema result in variations in the geometry and symmetry of multi-cuspid valvular shunts due to radial cutting from a puncture site, leading to reduced valve performance and increased backflow, and uncertainty in pressure regulation between the left and right atria.
Innovation Solution
The technique involves initiating cuts of septal wall tissue radially outward from the intersection of cuts and cutting inward to form a multi-cuspid valvular shunt, using expandable members with cutting elements to ensure consistent cut lengths and symmetry, and optionally employing distal and proximal support structures to stabilize the tissue during cutting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If cutting is initiated radially outwards from a puncture site, then the cutting procedure is simpler to perform, but the cut lengths and shunt geometry become variable and asymmetric
Solution Approach 1:
The patent inverts the conventional cutting approach by initiating cuts radially inwards from the intersection point toward the puncture site, rather than cutting radially outwards from the puncture site. This inversion ensures that all cuts meet at a predetermined central intersection, guaranteeing symmetric and consistent shunt geometry while maintaining procedural simplicity
Solution Approach 2:
The patent performs preliminary positioning of the cutting tool at the intersection point before initiating cuts. By establishing the central intersection point first and then cutting inwards from there, the procedure pre-determines the geometry and symmetry of the shunt, eliminating variability in cut lengths
2Productivity
If cutting is performed radially outwards from the puncture site, then the cutting process is faster, but the valve performance deteriorates due to asymmetric cuspids
Solution Approach 1:
The patent reverses the cutting direction to achieve both speed and reliability. By cutting inwards from the intersection point, the procedure maintains efficiency while ensuring that all cuspids are symmetrically formed, which is essential for proper valve function and preventing backflow
Solution Approach 2:
The patent deliberately creates symmetric geometry by cutting inwards from a central intersection point. This approach ensures that all cuspids are equal in length and properly positioned, creating the necessary symmetry for reliable valve performance rather than accepting asymmetric results
3Adaptability or versatility
If cuts are made without predetermined intersection point, then the cutting procedure is more flexible, but the shunt geometry and symmetry become uncertain
Solution Approach 1:
The patent performs the preliminary action of establishing the intersection point and determining cut lengths before actually making the cuts. This pre-planning ensures that the shunt will have consistent geometry and symmetry while still allowing flexibility in adapting to different patient anatomies
Solution Approach 2:
The patent uses imaging and measurement techniques beforehand to account for variations in septal wall thickness and anatomy. By planning the cut paths and intersection point in advance, the procedure cushions against anatomical variations and ensures consistent shunt geometry
Data Source
AI summary
An example medical device includes an elongated support member defining a longitudinal axis and a plurality of expandable members at a distal portion of the elongated support member positioned circumferentially about the elongated support member. At least a portion of each of the expandable members is configured to radially extend from the elongated support member. Each expandable member of the plurality of expandable members comprises a respective cutting element, each cutting element comprising a cutting surface facing towards the longitudinal axis and configured to initiate a respective cut of septal wall tissue at a first end of the respective cut and to cut the septal wall tissue from the first end of the cut to a second end of the respective cut to form a multi-cuspid valvular shunt. The second end of the cut comprises an intersection of the plurality of cuts of the plurality of cutting elements.