Complex Tapered Dilator Tips for Trans-septal Access
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Solution Overview
Problem
Current medical procedures for accessing heart chambers using trans-septal approaches face challenges such as tissue damage and undesired punctures due to dilator tips being too long, which can cause left atrial perforation or damage to undesired anatomy.
Innovation Solution
The development of dilators with complex tapered distal tips, featuring multiple tapered regions with different angles, and a system comprising a guide sheath, needle, and dilator that allows for controlled tissue dilation with a consistent axial force, minimizing the risk of 'jumping' and tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a long dilator taper is used to reduce axial force, then the axial dilation force is reduced, but the risk of tissue damage and undesired punctures increases
Solution Approach 1:
The dilator tip is segmented into multiple tapered regions with different angles rather than using a single uniform taper. This includes a first tapered region with a first angle and a second tapered region with a second angle, allowing different sections to perform different functions in the dilation process
Solution Approach 2:
Different regions of the dilator tip are given different local properties through varying taper angles. The first tapered region has a steeper angle for initial tissue engagement, while the second tapered region has a shallower angle for controlled expansion, optimizing both force distribution and safety
2Object-affected harmful factors
If a short dilator tip is used to improve safety, then the risk of tissue damage is reduced, but the axial force required for dilation increases
Solution Approach 1:
The dilator tip is divided into multiple tapered regions that work sequentially, allowing a shorter overall tip length to achieve the same dilation effect that would otherwise require a longer uniform taper
Solution Approach 2:
The taper angle parameter is changed along the length of the dilator tip, transitioning from a steeper angle in the first region to a shallower angle in the second region, optimizing both force requirements and safety
3Ease of manufacture
If a uniform conical taper is used on the dilator tip, then the manufacturing is simple, but the axial force varies during advancement
Solution Approach 1:
The dilator tip is segmented into multiple tapered regions with different angles, which can be manufactured using standard machining processes while achieving non-uniform force distribution
Solution Approach 2:
Different local regions of the tip have different taper angles to provide consistent axial force during advancement, with the first region handling initial penetration and the second region providing controlled expansion
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 enables safe and controlled access to heart chambers by maintaining consistent axial dilation force and reducing the risk of tissue damage and undesired punctures, facilitating effective medical procedures while minimizing the risk of complications.
Implementation Method 1
the tissue dilation forces applied to the tissue surrounding the puncture, as a function of diameter, may not be linear... the dilator tip may include multiple tapered regions having different taper angles... configured to provide a substantially consistent 'axial dilation force'
Data Source
AI summary
Devices and methods are provided for performing a medical procedure using a trans-septal approach. The device includes a dilator including a proximal end, a distal end terminating in a distal tip, and a lumen extending between the dilator proximal and distal ends, and a needle device including a proximal end, a distal end sized for introduction into the dilator lumen and terminating in a sharpened distal tip. The needle is movable relative to the dilator to selectively expose the needle device distal tip distally from the dilator lumen and advance the dilator relative to the needle device. The dilator may have a complex tapered shape on its distal tip, e.g., including first and second tapered regions. The needle device may include an inner needle including the sharpened distal tip and an outer tube including a substantially blunt distal end that slidably receives the inner needle.