Laser-Filleted Atraumatic Tip for Smooth Transseptal Advancement
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Solution Overview
Problem
Existing medical devices, particularly those used in transseptal procedures, face challenges with rough or uneven surfaces at the atraumatic tip, leading to tissue damage and surgical complications due to undesired tearing or catching during advancement.
Innovation Solution
A method involving laser processing to create a smooth, atraumatic tip through shaping, filleting, and smoothing steps, using precise laser ablation profiles to achieve a final tip configuration with perpendicular and angled sections, ensuring minimal tissue damage and efficient energy delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If layers of materials are applied to provide insulation and electrical conductivity, then the desired functional properties are achieved, but the surface becomes rough or uneven causing tissue damage
Solution Approach 1:
The patent applies a coating layer to the atraumatic tip before final assembly. This preliminary coating step creates a smooth surface that prevents tissue damage while maintaining the functional properties of the underlying materials. The coating is applied to the tip portion that will contact tissue, ensuring that any roughness from layered materials is eliminated before the device is used.
2Object-affected harmful factors
If an atraumatic tip is used to reduce damage during puncture, then tissue damage is reduced, but rough edges on the tip cause tearing and catching during advancement
Solution Approach 1:
The patent creates a rounded, curved tip geometry rather than a flat or angular one. The atraumatic tip features a smooth, continuous surface curvature that eliminates sharp edges. This curved geometry allows the tip to glide through tissue without catching or tearing, while the rounded shape distributes mechanical stress to prevent localized damage during puncture.
Solution Approach 2:
The coating is applied preliminarily to the tip surface to create a smooth, low-friction layer that facilitates advancement. This preliminary surface treatment ensures that the tip moves smoothly through tissue during insertion without causing tearing or resistance, while the underlying atraumatic geometry maintains tissue protection.
3Manufacturing precision
If multiple laser passes with different ablation profiles are used, then the tip surface is smoothed, but the manufacturing process becomes more complex
Solution Approach 1:
The laser processing is divided into multiple passes with different ablation profiles, where each pass targets specific surface features. The first pass removes bulk material and creates the basic tip geometry, while subsequent passes with different profiles progressively smooth the surface and eliminate rough edges. This segmented approach achieves high precision surface quality through systematic, controlled steps rather than a single complex operation.
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 method results in a device with atraumatic tips that reduce tissue damage, enhance navigation, and ensure controlled energy delivery, improving procedural safety and efficacy.
Implementation Method 1
directing a laser beam to the distal end of the body in a shaping step to create a shaped tip, the shaping step comprising a first number of passes with a first ablation profile diameter
Data Source
AI summary
Provided is a method for creating an atraumatic tip using a laser, the method comprising positioning a puncture device distal end relative to the laser, wherein the device is configured to rotate around a longitudinal axis to intersect the laser beam; directing the laser beam to the distal end to create a desired shape of the distal end of the body defining a first tip profile; directing the laser beam towards the first tip profile to create a fillet on the distal end of the body, wherein creating the fillet may comprise at least one tip profile, wherein each tip profile comprises a diameter ablation profile; and directing the laser beam to the fillet to smooth the distal end of the body, wherein the smoothing of the distal end of the body comprises at least one tip profile comprising a diameter and a power level.


