Sensor-Guided Renal Denervation Energy Delivery for Bradycardia Control
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Solution Overview
Problem
Existing renal denervation procedures face challenges in automatically detecting and managing changes in heart rate to prevent bradycardia, leading to potential delays and complications due to the need for manual clinician intervention.
Innovation Solution
A therapeutic assembly with integrated sensors and energy delivery elements that continuously monitor temperature or impedance to determine heart rate, allowing automatic adjustment of energy delivery to prevent bradycardia by controlling the energy output.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual monitoring and clinician intervention is used to detect and manage bradycardia, then the system can respond to heart rate changes, but procedural delays occur and treatment effectiveness is reduced
Solution Approach 1:
The system performs self-monitoring of heart rate through integrated sensors and self-adjustment of energy delivery without requiring external clinician intervention. The device automatically detects bradycardia and modifies its operation, enabling the system to serve itself in real-time during the procedure.
Solution Approach 2:
The system continuously monitors heart rate via sensors and uses this feedback to automatically adjust energy delivery parameters. This closed-loop control ensures immediate response to bradycardia detection, eliminating the delays associated with manual monitoring and clinician decision-making.
2Productivity
If continuous heart rate monitoring and automatic adjustment are implemented, then procedural delays are minimized, but device complexity increases
Solution Approach 1:
The system merges the monitoring function and energy delivery function into a single integrated device. By combining these functions, the system eliminates the need for separate monitoring equipment and manual coordination, reducing overall system complexity while maintaining continuous monitoring and automatic adjustment capabilities.
Solution Approach 2:
The device performs multiple functions including energy delivery, heart rate monitoring, bradycardia detection, and automatic adjustment through a single integrated system. This multi-functionality reduces the need for multiple separate devices and manual interventions, improving procedural efficiency without proportionally increasing complexity.
3Reliability
If energy delivery is reduced to prevent bradycardia, then heart rate is maintained, but treatment effectiveness may be compromised
Solution Approach 1:
The system dynamically adjusts energy delivery parameters in real-time based on continuous heart rate monitoring. When bradycardia is detected, the system automatically modulates energy output to maintain heart rate within acceptable ranges while preserving treatment effectiveness. This dynamic control allows the system to optimize between safety and treatment efficacy.
Solution Approach 2:
The system changes operational parameters such as energy delivery magnitude and duration in response to detected bradycardia. By adjusting these parameters dynamically, the system maintains heart rate stability while continuing to achieve the intended treatment outcome, balancing safety with therapeutic effectiveness.
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 system promptly adjusts energy delivery to maintain a normal heart rate, reducing the risk of bradycardia and minimizing procedural delays, thus enhancing safety and efficiency during renal denervation.
Implementation Method 1
a first sensor that is configured to continuously detect a first temperature or a first impedance at a first location of a wall of a vessel
Implementation Method 2
a first sensor that is configured to continuously detect a first temperature or a first impedance at a first location of a wall of a vessel
Implementation Method 3
a first energy delivery element that is configured to delivery energy to a nerve in the wall of the vessel
Implementation Method 4
uses stimuli or energy, such as radiofrequency, ultrasound, cooling or other energy, to perform ablation within the renal arteries
Implementation Method 5
these systems often rely on robust arterial blood flow to convectively cool the energy delivery elements, such as RF electrodes
Data Source
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AI summary
Methods, systems, devices, assemblies and apparatuses for renal denervation. The therapeutic assembly includes a first sensor that is configured to detect a first temperature or a first impedance. The therapeutic assembly includes a first energy delivery element that is configured to delivery energy to the wall of the vessel. The therapeutic assembly includes a processor. The processor is configured to determine a heart rate based on the first temperature or the first impedance. The processor is configured to determine that the heart rate is less than a threshold heart rate that indicates a slowing of the heart rate. The processor is configured to control the first energy delivery element to adjust the delivery of the energy to the wall of the vessel.