Steerable Introducer Sheath with Echocardiographic Guidance
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Solution Overview
Problem
Interventional cardiologists lack proficiency in safely and accurately puncturing the interatrial septum due to infrequent performance of transseptal procedures, and existing imaging methods like fluoroscopy are limited in visualizing soft tissues, necessitating improved tools for echocardiographic guidance.
Innovation Solution
A steerable introducer sheath assembly with a handle portion, a device lumen, guidewire lumen, and steering cable lumens, featuring a gear assembly and device locking mechanism to facilitate precise control and curvature of the sheath for enhanced echocardiographic image guidance during interatrial septum puncture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Illumination intensity
If fluoroscopy is used to guide transseptal puncture, then the procedure can be performed with existing imaging infrastructure, but the ability to visualize soft tissue like the interatrial septum is limited
Solution Approach 1:
The patent combines fluoroscopy with echocardiographic imaging to create a hybrid imaging approach. The introducer sheath assembly includes echocardiographic imaging capabilities that work alongside fluoroscopy, allowing operators to visualize both bone/contrast structures (via fluoroscopy) and soft tissue structures like the interatrial septum (via echocardiography), thereby resolving the limitation of fluoroscopy alone.
2Productivity
If interventional cardiologists perform transseptal procedures infrequently, then they maintain lower procedural volume, but their proficiency in safely and accurately puncturing the interatrial septum decreases
Solution Approach 1:
The patent incorporates real-time echocardiographic imaging feedback into the transseptal puncture procedure. The imaging system provides continuous visual feedback about the position of the puncture needle relative to the interatrial septum, allowing operators to make precise adjustments regardless of their experience level. This feedback mechanism compensates for the lack of procedural volume and maintains high puncture accuracy.
Solution Approach 2:
The patent replaces reliance on operator skill and experience (mechanical expertise) with an imaging-guided system. Instead of depending on the operator's manual dexterity and anatomical knowledge alone, the system uses echocardiographic imaging to guide the puncture, substituting technological assistance for human expertise and thereby maintaining accuracy even with low procedural volume.
3Ease of operation
If a steerable introducer sheath assembly with gear assembly is used, then precise control and curvature adjustment are achieved, but the device complexity increases
Solution Approach 1:
The patent divides the steering control system into separate, modular components: a gear assembly for controlling one plane of curvature and a ratchet mechanism for maintaining the selected curvature. This segmentation allows each component to be optimized independently and simplifies the overall control architecture, making the device easier to operate despite the added precision capabilities.
Solution Approach 2:
The patent implements a dynamic control system where the gear assembly allows continuous adjustment of sheath curvature in one plane, while the ratchet mechanism provides discrete locking positions. This combination of continuous and discrete control elements allows for precise positioning while maintaining operational simplicity, as the operator can adjust curvature dynamically and then lock it in place.
Data Source
AI summary
An introducer sheath assembly having a handle portion including a front end and a rear end, and a introducer sheath extending outwardly from the front end of the handle portion, the introducer sheath including a device lumen configured to slidably receive a corresponding device, a guidewire lumen configured to slidably receive a corresponding guidewire, a first steering cable lumen, a second steering cable lumen, a first steering cable disposed in the first steering cable lumen and a second steering cable 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.