Multi-Faceted Surgical Dilator Tip for Controlled Off-Lumen Access
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Solution Overview
Problem
Existing surgical dilators face challenges in accurately accessing off-lumen targets due to uncontrolled advancement, potential misalignment, and risk of puncturing nearby vessels or causing pneumothorax, especially when navigating through tissue lumens.
Innovation Solution
Surgical dilators with a control handle and a multi-faceted shaped tip that can be rotated to navigate through tissue without misalignment, featuring a tubular body with a constant diameter and a tapered tip with multiple facets for precise advancement and cutting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a surgical dilator is forced or pushed through a tissue lumen wall, then the dilator can penetrate the lumen wall, but sudden and uncontrolled advances may occur leading to puncture of nearby blood vessels or pneumothorax
Solution Approach 1:
The dilator incorporates a shape memory alloy (SMA) section that can dynamically change its mechanical properties between rigid and flexible states. During advancement, the SMA is heated to become rigid for penetrating the lumen wall, then cooled to become flexible for controlled navigation, preventing sudden uncontrolled advances while maintaining penetration capability.
Solution Approach 2:
The mechanical properties of the dilator are changed by controlling the temperature of the shape memory alloy section. By heating the SMA to its transformation temperature, the dilator becomes rigid for wall penetration; by cooling it below the transformation temperature, the dilator becomes flexible for controlled advancement, thus adjusting parameters to prevent both sudden advances and punctures.
2Strength
If a stiff surgical dilator is used to penetrate the lumen wall, then the dilator can effectively break through the wall, but it may cause straightening and misalignment of the guide catheter and endoscope
Solution Approach 1:
The dilator transitions from a flexible state during catheter insertion to a rigid state during wall penetration by heating the SMA section. After penetration, it returns to a flexible state, allowing the guide catheter and endoscope to maintain their curved alignment without being straightened by a permanently stiff dilator, thus preserving alignment accuracy while maintaining penetration strength.
Solution Approach 2:
The dilator is divided into distinct sections with different mechanical properties: a flexible proximal section for navigation, a shape memory alloy middle section that can become rigid for penetration, and a distal section for target engagement. This segmentation allows the penetration function to be performed only where needed without the entire dilator being stiff, preventing misalignment of downstream components.
3Device complexity
If a surgical dilator is designed to be simply forced through tissue, then the structure can be simple, but the likelihood of misalignment during advancement increases
Solution Approach 1:
Rather than adding complex control mechanisms, the invention changes the physical parameter of the dilator material itself by using shape memory alloy that transitions between rigid and flexible states through temperature control. This allows a relatively simple structure to achieve precise alignment control by temporarily changing material properties during critical phases of advancement.
Data Source
AI summary
The present disclosure describes surgical dilators including a multi-faceted shaped tip and methods of use associated therewith.