Vapor Ablation System with Impedance-Based Control
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Solution Overview
Problem
Current steam-based ablation systems face challenges with inconsistent vapor delivery due to complex interactions of multiple variables, potential overheating, and the need for costly and complex sensors to monitor vapor quality and tissue temperature, leading to unreliable treatment and safety concerns.
Innovation Solution
A vapor ablation system that uses a controller to generate heated vapor by passing electrical current through a bipolar electrode in a catheter, controlling flow rate and power based on input treatment time or energy level without relying on sensors within the catheter, ensuring consistent and controlled steam delivery directly to the tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If sensors are used to monitor vapor quality and tissue temperature, then measurement precision is improved, but device complexity and cost increase
Solution Approach 1:
The system uses the existing bipolar electrode to perform dual functions: delivering electrical current for vapor generation and measuring impedance to infer vapor quality and tissue temperature. This self-service approach eliminates the need for separate sensors, reducing device complexity while maintaining measurement capability through electrical impedance measurements that correlate with thermal and vaporization states
Solution Approach 2:
The bipolar electrode is designed as a multi-functional component that simultaneously serves as both the heating element for vapor generation and the sensing element for monitoring vapor quality and tissue temperature through impedance measurements. This universal component approach consolidates multiple functions into a single element, reducing overall system complexity and cost
2Temperature
If resistive heating is used to vaporize ablation fluid, then vapor generation is achieved, but vapor delivery consistency deteriorates due to heat transfer variability
Solution Approach 1:
The system continuously monitors electrical impedance across the bipolar electrode and uses this feedback to dynamically adjust the electrical current delivery. Since impedance changes with temperature and vaporization state, this closed-loop control compensates for heat transfer variability, maintaining consistent vapor generation and delivery despite changes in fluid flow, tissue contact, or thermal conditions
Solution Approach 2:
The system dynamically adjusts electrical parameters (voltage, current, power) based on real-time impedance measurements to maintain optimal vaporization conditions. By changing electrical parameters in response to measured conditions, the system compensates for thermal variability and maintains reliable vapor delivery across different operating conditions
3Object-affected harmful factors
If wire cooling time is required to stop vaporization, then overheating is prevented, but treatment time increases
Solution Approach 1:
The system uses real-time impedance monitoring to detect the onset of overheating conditions and immediately adjusts or terminates electrical current delivery. This active feedback control prevents the need for extended cooling periods, as the system can stop vaporization instantly by cutting power when temperature thresholds are approached, significantly reducing non-productive cooling time
Solution Approach 2:
The system rapidly transitions between vaporization and cooling states by instantly adjusting electrical current based on impedance feedback. Instead of gradual cooling, the system rushes through the treatment by immediately stopping energy delivery when cooling is needed, minimizing the time spent in non-treatment cooling phases while still preventing overheating
4Object-affected harmful factors
If pressure sensors are used to regulate energy delivery, then safety is improved, but reliability deteriorates due to critical failure points
Solution Approach 1:
The bipolar electrode performs self-diagnosis by measuring its own electrical impedance, which naturally changes with temperature, vaporization, and tissue contact conditions. This self-monitoring capability provides safety information without requiring external pressure sensors, eliminating a critical failure point while maintaining the ability to detect and respond to unsafe conditions through impedance-based anomaly detection
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 provides reliable and controlled steam delivery, reducing the risk of overheating and tissue damage, while eliminating the need for costly sensors, ensuring efficient and safe ablation procedures without gaps or overlaps in treatment areas.
Implementation Method 1
causing the controller to generate an electrical current and direct the electrical current to the at least one bipolar electrode such that the electrical current passes through the fluid positioned proximate the at least one bipolar electrode and causes the fluid to be transformed to a heated vapor
Implementation Method 2
a pump in data communication with the controller... controlling a flow rate of the fluid and at least one of a level of power, voltage, current, and a time of treatment, based on data indicative of at least one of the time or the energy level to be achieved within the treatment session
Data Source
AI summary
Ablation systems and methods include an improved approach to generating heated vapor. The system includes a controller having a user interface and receives data indicative of a treatment time or desired energy level to be delivered during a treatment session, a pump in data communication with the controller, and a catheter having a bipolar electrode in fluid communication with the pump. The controller is configured to control a delivery of fluid and a generation of heated vapor based on the data indicative of the treatment time or desired level of energy to be delivered without modifying the flow rate of the fluid or the level of voltage and/or current of the electrical current based on data from sensors positioned in or on the catheter.