Rotatable Jaw Clamp for Adaptable Cardiac Lesion Formation
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Solution Overview
Problem
Current surgical probes and clamps used for forming lesions in body tissue, such as those treating cardiac conditions, face challenges in accommodating varying tissue sizes, shapes, and densities, often resulting in incomplete or irregular lesions due to fixed electrode configurations and limited adjustability.
Innovation Solution
The development of a bipolar clamp system with rotatable jaw mechanisms and adjustable electrode assemblies, allowing for flexible angular orientation and rotation, enabling the creation of continuous lesions in various three-dimensional configurations, and incorporating temperature control for precise energy delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If fixed electrode configurations are used in surgical probes and clamps, then device structure is simple, but the ability to accommodate varying tissue sizes, shapes, and densities is limited
Solution Approach 1:
The clamp system incorporates rotatable jaw mechanisms that allow dynamic adjustment of the clamp members' orientation and positioning. The jawbones can rotate relative to the clamp members, enabling the electrodes to be oriented at different angles and positions to accommodate various tissue geometries and densities, transforming a static device into an adaptable one.
Solution Approach 2:
The clamp system is divided into separable functional components: clamp members for tissue grasping, rotatable jawbones for orientation adjustment, and electrodes for energy delivery. This segmentation allows independent optimization of each component and enables flexible reconfiguration to match different tissue characteristics during the procedure.
2Adaptability or versatility
If fixed angular orientation is used in surgical probes, then manufacturing is simpler, but the ability to create continuous lesions in various three-dimensional configurations is restricted
Solution Approach 1:
The jawbones are designed to rotate relative to the clamp members through a defined range of motion, allowing the electrode orientation to be dynamically adjusted in three-dimensional space. This rotational capability enables continuous lesions to be formed along curved or angled tissue surfaces without requiring multiple fixed-angle probes.
Solution Approach 2:
A single clamp system with rotatable jawbones can perform multiple lesion formation tasks that would otherwise require different fixed-angle probes. The universal design allows the same device to create lesions in various three-dimensional configurations by simply rotating the jawbones to the appropriate orientation.
3Manufacturing precision
If precise energy delivery is required for lesion formation, then treatment effectiveness improves, but control over energy application becomes more complex
Solution Approach 1:
The clamp system incorporates temperature sensors that continuously monitor the tissue temperature during RF energy delivery. This feedback is used to control the power output, automatically adjusting or terminating energy application when predetermined temperature thresholds are reached, ensuring precise and safe lesion formation without requiring complex manual control.
Solution Approach 2:
The system uses automatic temperature-controlled RF energy delivery where the device self-regulates power output based on real-time temperature measurements. This self-service capability eliminates the need for complex external control mechanisms while maintaining precise energy delivery and preventing overheating.
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
This solution allows for efficient and precise formation of lesions in complex anatomical structures, improving treatment outcomes for conditions like atrial fibrillation by enabling flexible access and precise energy application, regardless of tissue size or shape, and enhancing the surgeon's ability to approach the anatomy from different directions.
Implementation Method 1
Electromagnetic radio frequency ('RF') energy applied by the electrode heats and eventually kills or ablates the tissue to form a lesion.
Implementation Method 2
Electromagnetic radio frequency ('RF') energy applied by the electrode heats and eventually kills or ablates the tissue
Implementation Method 3
During the ablation of soft tissue (e.g. tissue other than blood, bone and connective tissue), tissue coagulation occurs, which leads to tissue death.
Data Source
AI summary
Tissue treatment systems include an actuator handle assembly coupled with a clamp assembly having a first jaw mechanism and a second jaw mechanism. A first jaw mechanism includes a first flexible boot, a first flexible ablation member coupled with the first flexible boot, and a first rotatable jawbone disposed within the first flexible boot. A second jaw mechanism comprises a second flexible boot, a second flexible ablation member coupled with the second flexible boot, and a second rotatable jawbone disposed within the second flexible boot.