Steerable Introducer Sheath with Gear Assemblies

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Solution Overview

Problem

Interventional cardiologists lack proficiency in safely and accurately puncturing the interatrial septum due to infrequent practice, and existing imaging methods like fluoroscopy are limited in visualizing soft tissues, necessitating a tool that enhances echocardiographic image guidance for precise septal crossing.

Innovation Solution

A steerable introducer sheath assembly with a handle portion, multiple steering cable lumens, and gear assemblies that allow for precise curvature control of the sheath's distal portion, facilitating safe and accurate puncture of the interatrial septum, integrated with echocardiographic imaging for enhanced guidance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If fluoroscopy is used to guide transseptal puncture, then the procedure can be performed, but the ability to image soft tissue like the interatrial septum is limited

Engineering Contradiction:
Improveimaging capabilityVSAvoidguidance accuracy
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent combines echocardiographic imaging capability with the introducer sheath assembly, integrating ultrasound transducers directly into the sheath to provide real-time soft tissue visualization during transseptal puncture, thereby overcoming fluoroscopy's limitation in imaging soft tissue while maintaining procedural guidance

Inventive Principle:
Principle #5Merging (Combining)

2Productivity

If interventional cardiologists perform transseptal puncture infrequently, then they can focus on other procedures, but their proficiency in safely and accurately crossing the septum decreases

Engineering Contradiction:
Improveprocedure efficiencyVSAvoidpuncture safety
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent incorporates real-time echocardiographic imaging feedback into the introducer sheath assembly, allowing cardiologists to visualize the puncture process and sheath positioning continuously, which compensates for lack of procedural experience by providing enhanced visual guidance and reducing reliance on operator proficiency

Inventive Principle:
Principle #23Feedback

3Manufacturing precision

If a steerable introducer sheath assembly with multiple steering cable lumens and gear assemblies is used, then precise curvature control is achieved, but the device complexity increases

Engineering Contradiction:
Improvecurvature control precisionVSAvoidsheath assembly structure
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent segments the steering control system into multiple independent steering cable lumens (first, second, and third) with corresponding gear assemblies, allowing precise control of different segments of the sheath's curvature through individual cable tensioning, achieving complex three-dimensional positioning through coordinated control of segmented components

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3187222B1Steerable introducer sheath assembly
Publication Date: 2019.09.25 510 KARDIAC DEVICES INC
  • EP3187222B1 patent drawingFigure 1
  • EP3187222B1 patent drawingFigure 2
  • EP3187222B1 patent drawingFigure 3~4

AI summary

An introducer sheath assembly 100 having a handle portion 110 including a front end and a rear end, and a introducer sheath 130 extending outwardly from the front end of the handle portion, the introducer sheath including a device lumen 140 configured to slidably receive a corresponding device, a guidewire lumen 142 configured to slidably receive a corresponding guidewire, a first steering cable lumen 146, a second steering cable lumen 148, a first steering cable 154 disposed in the first steering cable lumen and a second steering cable 156 disposed in the second steering cable lumen, wherein the first steering cable lumen, the second steering cable lumen and the guidewire lumen are disposed radially outwardly from the device lumen.