Sheath Visualization with Integrated Electrical Traces
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Solution Overview
Problem
Conventional medical sheaths and catheters lack visualization capabilities, making it difficult for physicians to accurately position them during procedures, especially when using manual control or automated guidance systems, leading to increased procedure time and potential complications.
Innovation Solution
The design incorporates a sheath body with electrodes, electrical traces, and a steering mechanism, allowing for improved visualization and control through the use of additive manufacturing and reflow processes to integrate conductive components, reducing manufacturing complexity and cost.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional sheaths and catheters are used without visualization components, then manufacturing cost and complexity are reduced, but visualization capability and positioning accuracy deteriorate
Solution Approach 1:
The patent combines the sheath body with electrodes, electrical traces, and imaging components into an integrated device. The electrodes are mounted directly on the sheath body, and the imaging components are incorporated into the sheath structure, allowing simultaneous visualization and medical procedure performance without separate devices
Solution Approach 2:
The sheath body serves multiple functions: it provides the structural conduit for medical procedures, incorporates electrodes for electrical signaling or sensing, includes imaging components for visualization, and integrates electrical traces for signal transmission. This multi-functional design eliminates the need for separate visualization devices
2Ease of operation
If electrodes and electrical traces are integrated into the sheath body, then visualization and control capabilities are improved, but manufacturing complexity increases
Solution Approach 1:
The electrical traces are pre-formed and integrated into the sheath body during manufacturing, with electrodes positioned and connected beforehand. This preliminary integration of electrical components simplifies subsequent assembly operations and ensures proper positioning before the device is used clinically
Solution Approach 2:
The electrical traces are embedded within or along the sheath body structure, with electrodes nested or mounted on the sheath surface. The electrical components are integrated within the structural framework of the sheath, creating a compact unified device
3Loss of information
If fluoroscopy is used for visualization, then real-time imaging is achieved, but ionizing radiation exposure and procedure cost increase
Solution Approach 1:
The patent introduces an intermediary imaging system that uses non-ionizing radiation (such as ultrasound or magnetic resonance imaging components) to provide visual information about sheath position and procedure progress, replacing the need for ionizing radiation-based fluoroscopy
Solution Approach 2:
The patent replaces the mechanical/optical system of fluoroscopy with an integrated imaging system that uses alternative physics principles (such as acoustic waves in ultrasound or magnetic field interactions) to achieve visualization without ionizing radiation
4Device complexity
If transseptal puncture is performed without visualization of sheath position, then procedure simplicity is maintained, but procedure time increases and complications arise
Solution Approach 1:
The integrated imaging components provide real-time feedback about sheath position and penetration depth during the transseptal puncture procedure, allowing the operator to visualize progress and make adjustments without losing visual contact, thereby preventing complications and reducing procedure time
Data Source
AI summary
Medical devices and systems including electrical traces are provided. The medical device includes a sheath body including an inner wall, an outer wall, and a central major lumen extending through the sheath body along a longitudinal axis. The central major lumen is defined by the inner wall. The medical device further includes at least one outer lumen extending through said sheath body, wherein the at least one outer lumen is disposed between the inner wall and the outer wall, at least one electrode coupled to a distal portion of said sheath body, and at least one electrical trace. Each of the at least one electrodes is coupled to at least one electrical trace, and the electrical trace is disposed between the inner wall and the outer wall.