Retractable Septal Cutting Tool for Stable Intraatrial Shunts
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Solution Overview
Problem
Current treatments for elevated pressures within the left atrium of the heart are limited, and there is a need for more effective therapies to manage heart failure and cardiovascular diseases, particularly in addressing left atrial enlargement and its associated complications.
Innovation Solution
A cutting tool with an elongate body and a hub-rotatable cutting element is used to create an intraatrial shunt by puncturing the septal wall, allowing for controlled and precise formation of a shunt between the right and left atria, optionally combined with ablation to ensure tissue separation and prevent regrowth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a mechanical stent is left in place to maintain the shunt, then the shunt structure is stable and prevents tissue regrowth, but the device complexity increases and requires additional components
Solution Approach 1:
The patent removes the mechanical stent component from the shunt system, relying instead on the puncturing device to create a permanent opening in the septal wall. This extraction of the stent component simplifies the device while maintaining shunt stability through the permanent tissue opening.
Solution Approach 2:
The patent replaces the mechanical stent structure with a puncturing/cutting mechanism that creates a permanent opening through tissue separation. This substitution eliminates the need for mechanical support structures while achieving the same functional outcome of maintaining shunt patency.
2Productivity
If the cutting element is always exposed for efficient cutting, then the cutting action is effective, but the risk of unintended tissue damage increases
Solution Approach 1:
The cutting element is nested within a protective sheath that can be retracted or advanced. When not in use, the cutting element is concealed within the sheath, protecting surrounding tissue. During the cutting procedure, the sheath is retracted to expose the cutting element for efficient tissue separation.
Solution Approach 2:
The cutting element transitions between static (retracted within sheath) and dynamic (exposed for cutting) states. This dynamic configuration allows the system to optimize both safety during navigation and cutting efficiency during the actual procedure.
3Reliability
If ablation is combined with cutting to prevent tissue regrowth, then the shunt permanence is improved, but the use of energy increases and the procedure complexity increases
Solution Approach 1:
The patent combines the mechanical cutting function with thermal ablation in a single integrated device. The cutting element creates the initial tissue separation, and the ablation component immediately follows to prevent tissue regrowth, achieving permanent shunt formation through a unified procedure.
Solution Approach 2:
The cutting action is performed first to create the opening, and ablation is applied subsequently to prevent regrowth. This preliminary cutting followed by ablation ensures that the tissue is properly separated before applying thermal energy to create a permanent barrier against regrowth.
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
The solution provides a controlled and efficient method to create a shunt, reducing symptoms of heart failure and other cardiovascular diseases by alleviating pressure, with the potential for a more permanent shunt formation using ablation.
Implementation Method 1
The cutting tool may include a cutting element... puncturing the septal wall with a distal end of the cutting tool to form an aperture within the septal wall
Implementation Method 2
rotating the hub in a first direction to form a shunt within the septal wall... with the potential for a more permanent shunt formation using ablation
Data Source
AI summary
A method, system, and devices with an integrated retractable blade system for the intraarterial shunt are disclosed. According to one aspect, the cutting tool may comprise an elongate body where the elongate body has a proximal portion and a distal portion opposite the proximal portion. An inner shaft may extend within the distal portion of the elongate body and the inner shaft may have a proximal end and a distal end and a hub may be coupled to the distal end of the inner shaft. The cutting tool may have a cutting element with the hub coupled with the cutting element and movement of the hub transitions the cutting element between a collapsed position and an expanded position.


