Cryoprobe Clamp Transmurality Window
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Solution Overview
Problem
Current surgical ablation devices for treating atrial fibrillation lack the ability to assess transmurality of lesions without relying on temperature or impedance measurements, and often require removal of the device from the tissue site, which can lead to improper placement and incomplete ablation.
Innovation Solution
A surgical clamp with opposing blade members that include a flexible ablation tool and a window on one blade, allowing for visual assessment of transmurality without removing the device from the tissue, utilizing cryogenic fluid for ablation and incorporating a handle assembly for precise movement of the blades.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If temperature or impedance measurements are used to assess transmurality, then transmurality can be indirectly assessed, but the assessment is less accurate and requires device removal for verification
Solution Approach 1:
The blade incorporates a window that allows direct visual observation of tissue color changes during ablation. As the tissue transitions from viable (red/pink) to ablated (white/pale), the surgeon can directly assess transmurality through the window without removing the device, providing accurate real-time feedback on ablation completeness
Solution Approach 2:
The window acts as an intermediary optical pathway between the ablation site and the surgeon's view. It transmits light from the tissue through the blade structure, enabling direct visualization of transmurality without requiring device removal or reliance on indirect electrical measurements
2Reliability
If the device is removed from the tissue site to assess transmurality, then visual verification can be obtained, but improper placement and incomplete ablation may occur
Solution Approach 1:
The window enables continuous visual monitoring of the ablation process throughout the procedure. The surgeon can observe tissue color changes in real-time without interrupting the ablation sequence, maintaining continuous useful action and eliminating time losses associated with device removal and repositioning
Solution Approach 2:
The blade's window structure provides self-visualization capability, where the blade itself serves as the viewing portal. The surgeon directly observes tissue changes through the window without needing to remove the device for assessment, making the system self-sufficient for transmurality evaluation
3Manufacturing precision
If opposing blade members are used to ablate tissue, then transmurality can be achieved, but the ability to visually assess the lesion is compromised
Solution Approach 1:
The blade structure incorporates a window in a specific location where it provides the necessary visual access to the ablation site. This local modification creates a differentiated structure where the windowed region serves the dual function of maintaining structural integrity while enabling optical transmission for transmurality assessment
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
Enables accurate visualization of lesion transmurality during the procedure, reducing the risk of incomplete ablation and improving surgical precision by allowing continuous monitoring through the window, thus enhancing treatment effectiveness and safety.
Implementation Method 1
A flexible ablation tool is connected to at least one of the blade members and is capable of conducting ablation energy through the tissue grasped therebetween
Implementation Method 2
a flexible ablation tool connected to at least one of the blade members, such that the blade members are capable of conducting ablation energy through the tissue grasped therebetween
Data Source
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AI summary
A cryoprobe clamp for creating a lesion in a target tissue comprises a housing portion, a handle extending from the housing portion, a clamp assembly including a distal blade and a proximal blade structured for clamping a target tissue therebetween, a trigger mechanism positioned adjacent the handle and operably coupled to the clamp assembly, and an ablation tool extending between the housing portion and the clamp assembly. The distal blade includes receiving means structured to receive a distal portion of the ablation tool, and the proximal blade includes an outer frame surrounding an open window portion. Upon clamping the target tissue between the distal and proximal blades, a lesion formed by the distal end of the ablation tool is visible through the window portion of the proximal blade.