Energy-Delivering Tissue Puncture Tip With Curved Dilator Support
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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, allowing it to conform to the curvature of steerable sheaths while maintaining sufficient rigidity for tissue advancement, combined with guidewires that provide reliable support and anchoring for punctures, enabling efficient access and reduced device exchanges.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a flexible dilator is used to conform to the curvature of steerable sheaths, then ease of operation and curvature maintenance are improved, but device complexity increases due to varying stiffness regions
Solution Approach 1:
The dilator is designed with varying stiffness regions along its length, where the proximal portion has different mechanical properties than the distal portion. This local quality variation allows the dilator to conform to curved sheaths in the proximal region while maintaining sufficient rigidity in the distal region for effective tissue puncture and advancement.
Solution Approach 2:
The dilator is segmented into distinct regions with different stiffness characteristics. The proximal section is more flexible to accommodate sheath curvature, while the distal section is stiffer for puncture function. This segmentation resolves the contradiction by allowing each segment to optimize for its specific functional requirement.
2Reliability
If guidewires provide reliable support and anchoring for punctures, then reliability and productivity are improved, but device complexity increases due to rail section design
Solution Approach 1:
The guidewire is designed with a rail section that serves multiple functions: it provides a rigid structure for supporting tubular members during advancement, acts as an anchor after puncture, and maintains the puncture site patency. This multi-functionality improves reliability while avoiding the need for separate devices for each function.
Solution Approach 2:
The rail section combines the support function and anchoring function into a single integrated structure. The rigid rail portion provides both the mechanical support needed for device advancement and the anchoring capability for maintaining puncture access, reducing overall system complexity despite the enhanced functionality.
3Strength
If the distal section has a reverse taper increasing in outer diameter, then strength and rigidity are improved for tissue advancement, but manufacturing precision requirements increase
Solution Approach 1:
The distal section employs a reverse taper where the outer diameter increases from the curved portion toward the straight portion. This gradual parameter change optimizes the strength and rigidity distribution along the dilator, allowing it to withstand advancement forces while transitioning from the flexible curved section to the rigid straight section for effective tissue puncture.
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 and guidewire system allows for efficient and repeatable puncture of tissue sites, reducing procedure time and maintaining access through varied anatomies, while minimizing device exchanges and ensuring proper curvature maintenance.
Implementation Method 1
an active tip at a distal end of the distal section and operable to deliver energy to create a puncture through the tissue
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.