Transvascular Denervation Catheter with Evoked Response Recording
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Solution Overview
Problem
Current renal denervation devices lack the ability to predict long-term outcomes and assess the completeness of the therapeutic procedure, as they rely on indirect parameters such as impedance, temperature, and power, which may not correlate with the extent of denervation due to the heterogeneous nature of vascular innervation structures.
Innovation Solution
A catheter device with deployable structures and sensors that record evoked responses from the vessel wall to derive a Denervation Assessment index (DNAi) by comparing pre-treatment and post-treatment recordings, allowing for direct measurement of residual neural activities and assessment of denervation completeness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If indirect parameters (impedance, temperature, power) are used to assess denervation, then the device structure remains simple, but the measurement precision is insufficient due to heterogeneous vascular innervation structures
Solution Approach 1:
The patent replaces indirect mechanical/thermal parameters (impedance, temperature, power) with direct electrophysiological measurements. Recording electrodes detect excitatory junctional potentials (EJPs) and mechanical responses directly from the vessel wall, providing precise denervation assessment without complex device structures.
Solution Approach 2:
The patent introduces evoked responses (EJPs and mechanical responses) as intermediary markers to assess denervation. These physiological responses serve as mediators between the neural stimulation and the denervation state, enabling accurate measurement through the vessel wall without direct nerve access.
2Measurement precision
If multiple sensors and deployable structures are added to directly measure neural activities, then the measurement precision improves, but the device complexity increases
Solution Approach 1:
The patent divides the assessment function into multiple sensing components: recording electrodes for EJPs, separate electrodes for mechanical responses, and stimulation electrodes. This segmentation allows each component to perform a specific measurement function, improving overall precision while maintaining manageable device complexity through modular design.
Solution Approach 2:
The deployable structure serves multiple functions: it positions recording electrodes, stimulation electrodes, and mechanical response sensors simultaneously against the vessel wall. This multi-functionality reduces the need for separate complex positioning mechanisms, thereby improving measurement precision without proportionally increasing device complexity.
3Reliability
If pre-treatment and post-treatment recordings are compared to derive DNAi, then the reliability of denervation assessment improves, but the procedure time increases
Solution Approach 1:
The patent implements a feedback mechanism where pre-treatment baseline recordings establish reference values for neural activity. Post-treatment recordings are then compared against these baselines to calculate the Denervation Assessment index (DNAi). This feedback approach provides reliable denervation completeness assessment while enabling real-time monitoring and immediate clinical decision-making.
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 a more direct and effective assessment of transvascular denervation by monitoring excitatory junctional potentials and mechanical responses, providing a reliable method to determine the completeness of renal denervation procedures and predicting clinical outcomes.
Implementation Method 1
the one or more recording elements configured to record one or more of evoked electrical responses or mechanical responses of the vessel in response to the nerve stimulating signals
Implementation Method 2
the one or more recording elements configured to record one or more of evoked electrical responses or mechanical responses of the vessel in response to the nerve stimulating signals
Implementation Method 3
the one or more ablation elements being powered to apply ablation energy to a vessel of a patient
Implementation Method 4
the one or more stimulation elements being powered to supply nerve stimulating signals to the vessel
Data Source
AI summary
A catheter apparatus for assessing denervation comprises: an elongated catheter body; a deployable structure coupled to the catheter body, the deployable structure being deployable outwardly from and contractible inwardly toward the longitudinal axis of the catheter body; one or more ablation elements disposed on the deployable structure to move outwardly and inwardly with the deployable structure; one or more stimulation elements spaced from each other and disposed on the deployable structure to move with the deployable structure, the stimulation elements being powered to supply nerve stimulating signals to the vessel; and one or more recording elements spaced from each other and from the stimulation elements, the recording elements being disposed on the deployable structure to move with the deployable structure, the recording elements configured to record response of the vessel to the nerve stimulating signals.