RF Electrode Catheter for PFO Closure
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Solution Overview
Problem
Conventional treatments for Patent Foramen Ovale (PFO) and other related cardiac defects often require invasive surgery, which poses risks to patients and are less efficient in closing the tissue opening effectively.
Innovation Solution
A medical device and method utilizing electrodes and sensors to deliver RF energy and measure tissue parameters, allowing for precise positioning and closure of the PFO by heating the tissue to stimulate regrowth and weld the defect shut, while also using sensors to determine the morphology and energy delivery profile tailored to the specific defect.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional surgical procedures are used to close PFO, then the tissue opening can be closed, but the procedure is invasive and poses risks to patients
Solution Approach 1:
The patent replaces conventional mechanical surgical procedures with a RF energy-based system. The RF electrode delivers electromagnetic energy to heat and weld the PFO tissue closed, eliminating the need for invasive mechanical suturing or clipping while achieving reliable closure.
Solution Approach 2:
The system uses RF energy to change the thermal parameters of the PFO tissue. By controlling the RF power delivery and monitoring tissue temperature, the system heats the tissue to appropriate temperatures for welding closure, transforming the tissue state to achieve closure without mechanical intervention.
2Object-affected harmful factors
If RF energy is used to close PFO, then the procedure becomes less invasive, but precise positioning and energy delivery control are required
Solution Approach 1:
The patent incorporates sensors that provide real-time feedback on tissue parameters (such as temperature, impedance, or morphology) during RF energy delivery. This feedback allows the control system to adjust energy delivery parameters dynamically, ensuring precise control and safe operation while maintaining a less invasive approach.
Solution Approach 2:
The system integrates multiple functions into a single catheter-based platform: navigation to the PFO, positioning of the RF electrode, delivery of RF energy, and real-time tissue parameter monitoring. This multi-functional integration manages device complexity by combining necessary components rather than requiring separate systems.
3Manufacturing precision
If sensors are used to monitor tissue parameters during PFO closure, then energy delivery can be optimized, but device complexity increases
Solution Approach 1:
The patent combines the RF electrode and sensors into an integrated catheter assembly. The sensors are positioned in close proximity to the RF electrode tip, allowing simultaneous measurement of tissue parameters and energy delivery at the same location. This merging reduces the number of separate components and simplifies the overall device architecture.
Solution Approach 2:
The sensors act as intermediaries between the RF energy delivery system and the tissue. They provide real-time information about tissue state (temperature, impedance changes) that mediates the control of RF energy delivery, enabling optimized and safe closure without requiring complex external monitoring systems.
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 enables a less invasive and more effective closure of PFO by using RF energy to heat and weld the tissue, reducing the size of the opening and promoting healing, while ensuring proper positioning and energy delivery based on real-time tissue feedback.
Implementation Method 1
deliver RF energy and measure tissue parameters, allowing for precise positioning and closure of the PFO by heating the tissue to stimulate regrowth and weld the defect shut
Data Source
AI summary
A medical device for reducing the size of a Patent Foramen Ovale is disclosed. The medical device can include a first electrode, a second electrode, and at least one sensor mounted to at least one of the first electrode or the second electrode, the at least one sensor adapted to sense at least one operating parameter of the medical device or the patient to facilitate closure of the Patent Foramen Ovale. The medical device can also include a delivery shaft coupled to the first electrode, wherein the delivery shaft includes an indicia for determining the position of the first electrode relative to the second electrode. A method for determining a characteristic of an internal tissue opening is also disclosed. The method can include the steps of introducing a detectable fluid in the right atrium of a heart and then detecting the location of the detectable fluid in the heart.