Passive Steerable Dilator for Transseptal Access
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Solution Overview
Problem
Current devices for transseptal crossing procedures lack efficiency in accessing the left atrium of the heart, requiring improved methods and apparatuses for creating and enlarging punctures in the atrial septum to facilitate larger device advancement.
Innovation Solution
A system comprising an outer cannula with a preset curve and an inner member of greater stiffness, allowing for controlled positioning and shape change, combined with a control mechanism and piercing member, including a radiofrequency electrode, to enhance puncture creation and enlargement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a dilator is advanced across the septal puncture to enlarge the opening, then larger-diameter devices can be advanced into the left atrium, but the ability to control the shape and positioning of the dilator is limited
Solution Approach 1:
The dilator incorporates an inner member that can change position relative to the outer cannula, allowing the shape of the dilator to be dynamically adjusted. The inner member can be in a retracted position for a first shape suitable for navigation and a deployed position for a second shape that provides support for advancing larger devices, enabling both adaptability and operator control.
Solution Approach 2:
The dilator is divided into an outer cannula and an inner member that can move independently relative to each other. This segmentation allows the inner member to be positioned differently within the outer cannula to change the overall shape and rigidity of the dilator, providing both adaptability for different procedural stages and control for the operator.
2Shape
If the inner member has greater stiffness than the outer cannula, then the inner member can effectively change the shape of the dilator, but the complexity of the device increases
Solution Approach 1:
The inner member is nested within the outer cannula, allowing the stiffer inner member to be contained within the more flexible outer cannula. This nesting arrangement enables the inner member to effectively change the shape of the overall dilator when deployed, while the outer cannula provides protection and structural support, achieving shape change capability without excessive device complexity.
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
Enables precise and effective transseptal access, allowing for the advancement of larger devices into the left atrium with improved control and flexibility, addressing the limitations of existing technologies.
Implementation Method 1
the piercing member includes a distal radiofrequency electrode
Data Source
AI summary
A system for use in a transseptal crossing procedure includes an outer cannula having a proximal end, a tapered distal end, a preset curve, and a proximal portion extending between the proximal end and the preset curve. An inner member is configured to slide within the outer cannula between a first position and a second position, the inner member has a stiffness greater than a stiffness of the outer cannula. In the first position the tapered distal end is positioned approximately 90 degrees relative to the proximal portion and in the second position the tapered distal end is positioned greater than 90 degrees relative to the proximal portion. A control mechanism includes a first portion connected to the outer cannula and a second portion connected to the inner member, and is configured to move the inner member between the first position and the second position.