Variable Spacing Clamp for Intimate Tissue Contact
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Solution Overview
Problem
Conventional electrophysiology devices face challenges in achieving intimate tissue contact and preventing mechanical damage when dealing with tissue structures of varying thickness, and they have high electrical resistance due to porous, wettable structures, which can lead to incomplete or non-transmural lesions during therapeutic procedures.
Innovation Solution
The development of a clamp-based electrophysiology device with variable spacing structures that adjust to accommodate thicker tissues without damaging them, combined with wettable structures enhanced by conductive fibers to reduce electrical resistance, and the integration of stimulation electrodes within the current path for precise lesion confirmation and evaluation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a clamp with fixed predetermined spacing between energy transmission surfaces is used, then intimate tissue contact is achieved for thin tissue structures, but mechanical damage occurs to thicker tissue structures
Solution Approach 1:
The clamp incorporates a resilient member that enables dynamic adjustment of the spacing between energy transmission surfaces. This resilient member allows the clamp to adapt its configuration based on tissue thickness, providing intimate contact for thin structures while preventing excessive compression damage to thicker structures.
Solution Approach 2:
The spacing between energy transmission surfaces is changed from a fixed predetermined value to a variable parameter that can adjust between a first spacing (for thin tissue) and a second spacing (for thick tissue). This parameter change allows the device to optimize performance across different tissue thicknesses.
2Reliability
If porous wettable structures are used for energy transmission, then tissue contact is improved, but electrical resistance increases
Solution Approach 1:
The energy transmission element uses a composite structure combining a porous wettable structure with an electrically conductive structure. The porous structure (such as hydrogel or sponge material) provides tissue contact and fluid retention, while the conductive structure (such as metal mesh or conductive polymer) provides low electrical resistance, creating a material that achieves both functions simultaneously.
3Manufacturing precision
If energy transmission surfaces are positioned close together, then intimate contact is achieved, but the device cannot accommodate thicker tissue structures
Solution Approach 1:
The clamp members are designed with relative movability, allowing the spacing between energy transmission surfaces to dynamically adjust based on tissue thickness. This dynamic configuration maintains precise lesion formation capability while adapting to different tissue dimensions.
Solution Approach 2:
The clamp structure is divided into segments including first and second clamp members that can move relative to each other. This segmentation allows independent adjustment of the spacing between energy transmission surfaces while maintaining overall clamp functionality.
4Device complexity
If stimulation electrodes are positioned outside the current path, then device complexity is reduced, but lesion confirmation accuracy decreases
Solution Approach 1:
Stimulation electrodes are merged with the energy transmission elements, positioning them within the current path between the first and second energy transmission surfaces. This integration allows the same structural elements to serve dual functions: energy transmission for lesion formation and stimulation for lesion confirmation, improving measurement precision without proportionally increasing device complexity.
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
The solution ensures intimate tissue contact and reduced mechanical damage across varying tissue thicknesses, improves energy transmission efficiency by lowering electrical resistance, and allows for accurate lesion confirmation and evaluation without moving the device, leading to more effective and complete therapeutic lesions.
Implementation Method 1
they have high electrical resistance due to porous, wettable structures, which can lead to incomplete or non-transmural lesions during therapeutic procedures
Implementation Method 2
Electromagnetic radio frequency ('RF') may, for example, be used to heat and eventually kill (i.e. 'ablate') tissue to form a lesion
Implementation Method 3
Energy from the ESU is transmitted through the energy transmission elements to the tissue to from a lesion
Implementation Method 4
tissue coagulation occurs and it is the coagulation that kills the tissue. Thus, references to the ablation of soft tissue are necessarily references to soft tissue coagulation. 'Tissue coagulation' is the process of cross-linking proteins in tissue to cause the tissue to jell
Data Source
AI summary
An apparatus including a tissue coagulation device that creates a current path and a stimulation electrode carried within the current path.