Flexible Dilator and Guidewire for Stable Transseptal Puncture
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Solution Overview
Problem
Existing medical devices face challenges in efficiently accessing and puncturing tissue sites, particularly on the left side of the heart, due to limitations in curvature and stiffness of current sheaths and guidewires, leading to inefficient procedures and multiple device exchanges.
Innovation Solution
Development of a flexible dilator with varying stiffness regions, including a flexible intermediate section and a rigid distal end, designed to work with steerable sheaths, allowing for precise tissue access and puncture without impairing the sheath's curvature, combined with guidewires for robust support and maintenance of the puncture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid guidewire is used to maintain puncture stability, then puncture reliability is improved, but the ability to navigate curved tissue paths deteriorates
Solution Approach 1:
The guidewire is divided into three distinct segments with different stiffness characteristics: a proximal segment that is flexible for navigation, a mid-section that provides structural support, and a distal segment that is rigid for puncture stability. This segmentation allows each portion to perform its specific function optimally while working together as a unified device.
Solution Approach 2:
Different portions of the guidewire have different mechanical properties tailored to their specific functional requirements. The proximal segment has high flexibility for navigating curved vasculature, the mid-section has intermediate properties for transition and support, and the distal segment has high rigidity for maintaining puncture stability. This local differentiation of material or structural properties resolves the contradiction between overall flexibility and local rigidity needs.
2Adaptability or versatility
If a steerable sheath is used to access tissue sites, then access flexibility is improved, but device support capability deteriorates
Solution Approach 1:
The guidewire is inserted through and nested within the steerable sheath, creating a nested configuration where the flexible sheath provides steering capability while the internal guidewire provides structural support. This nesting arrangement allows the outer sheath to be steerable for accessing difficult-to-reach tissue sites while the inner guidewire maintains the necessary strength and stability for the procedure.
3Reliability
If multiple devices are exchanged during the procedure, then device functionality is optimized, but procedural efficiency deteriorates
Solution Approach 1:
The guidewire is designed as a multi-functional device that combines several capabilities in a single component: it provides navigation through flexible proximal segments, maintains puncture stability through rigid distal segments, supports delivery of additional devices, and can be configured for different access approaches. This multi-functionality eliminates the need to exchange multiple specialized devices, thereby improving procedural efficiency while maintaining optimized functionality.
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 flexible dilator enables efficient and repeatable puncture of tissue sites with reduced device exchanges, improving procedural efficiency and allowing transseptal puncture and lead delivery through a single access point.
Implementation Method 1
The medical device includes an active tip at a distal end of the distal section and is operable to deliver energy to create a puncture through the tissue
Implementation Method 2
the distal section defines a distal section curved portion configured to automatically form a distal coil in a deployed state for anchoring the distal section upon the distal section being advanced through the puncture
Data Source
AI summary
Novel and unique medical devices and associated methods are disclosed, for a medical device for puncturing tissue at a tissue site. The medical device includes an elongate member having a distal section defining a distal section curved portion and a distal section straight portion. The distal section straight portion is distal to the distal section curved portion. An active tip is located at a distal end of the distal section. The active tip is operable to deliver energy to create a puncture through the tissue. The medical device includes a constant diameter layer. The distal section straight portion includes a minimum diameter portion located proximal to a constant diameter portion, and the constant diameter layer surrounds the minimum diameter portion.