Renal Denervation Catheter With Nerve Sensing Feedback
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Solution Overview
Problem
Current renal sympathetic nerve ablation procedures lack real-time assessment of procedural success, leading to incomplete ablation and increased risks due to the inability to visualize nerves during the procedure, resulting in inconsistent therapeutic outcomes and potential complications such as renal artery damage.
Innovation Solution
A nerve sensing catheter (NSC) that integrates sensors to measure perivascular renal sympathetic nerve activity, allowing for real-time feedback on ablation effectiveness, combined with a perivascular nerve ablation catheter (PNASC) for precise and controlled delivery of ablative agents, reducing procedural time and pain.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If ablation procedure is performed without real-time assessment capability, then procedure simplicity is maintained, but ablation completeness and procedural success cannot be verified
Solution Approach 1:
The patent incorporates nerve activity sensors that provide real-time feedback during the ablation procedure. The sensors detect nerve activity levels and transmit this information to a display device, allowing the physician to assess whether the ablation is effectively reducing nerve activity and adjust the procedure accordingly to ensure complete ablation.
Solution Approach 2:
The patent introduces an intermediary assessment system consisting of sensors and display devices that mediate between the ablation device and the physician. This intermediary system translates invisible nerve activity into measurable signals that can be displayed, enabling indirect observation of ablation effectiveness without directly visualizing the nerves.
2Measurement precision
If invasive catheterization and radiation exposure are used for nerve visualization, then nerve location accuracy is improved, but patient risk and procedural complexity increase
Solution Approach 1:
The patent replaces the mechanical/invasive approach of catheterization and radiation-based visualization with an electrical sensing approach. The nerve activity sensors detect electrical signals from nerves without requiring physical insertion into the vessel or radiation exposure, thereby maintaining measurement precision while eliminating harmful factors.
Solution Approach 2:
The patent uses electrical fields as an intermediary to detect nerve activity non-invasively. Instead of directly visualizing nerves through invasive means, the sensors detect the electrical activity of nerves through the vessel wall, providing a non-invasive intermediary measurement that avoids radiation and procedural risks.
3Productivity
If ablation procedure is performed without real-time feedback, then procedure time is reduced, but need for repeat procedures increases
Solution Approach 1:
The real-time feedback from nerve activity sensors allows the physician to immediately assess ablation effectiveness and adjust the procedure accordingly. This eliminates the need for repeat procedures by ensuring complete ablation is achieved during the initial attempt, thereby improving productivity while reducing time loss from repeat procedures.
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
Enhances procedural success by ensuring complete nerve ablation, minimizing complications, and reducing the need for repeat procedures, while providing pain management through local anesthesia and shorter sedation requirements.
Implementation Method 1
a sensor, configured to detect electrical activity from perivascular renal sympathetic nerves through a wall of the renal artery
Implementation Method 2
A perivascular nerve ablation catheter (PNASC) for precise and controlled delivery of ablative agents
Data Source
AI summary
An intravascular catheter for nerve activity ablation and/or sensing includes one or more needles advanced through supported guide tubes (needle guiding elements) which expand to contact the interior surface of the wall of the renal artery or other vessel of a human body allowing the needles to be advanced though the vessel wall into the extra-luminal tissue including the media, adventitia and periadvential space. The catheter also includes structures which provide radial and lateral support to the guide tubes so that the guide tubes open uniformly and maintain their position against the interior surface of the vessel wall as the sharpened needles are advanced to penetrate into the vessel wall. Electrodes near the distal ends of the needles allow sensing of nerve activity before and after attempted renal denervation. In a combination embodiment ablative energy or fluid is delivered from the needles in or near the adventitia to ablate nerves outside of the media while sparing nerves within the media.