RF Balloon Catheter with Permeable Sections for Nerve Ablation
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Solution Overview
Problem
Current medical devices for nerve modulation and ablation, such as renal nerve ablation, face challenges in effectively targeting perivascular nerves while minimizing damage to adjacent tissues, particularly in intravascular procedures where precise temperature control and energy delivery are crucial.
Innovation Solution
The development of an intravascular catheter system with an inflatable balloon having permeable sections for radiofrequency radiation and strategically positioned electrodes, which uses a conductive fluid to transmit energy and facilitate cooling, allowing for precise nerve modulation and ablation while minimizing tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radio frequency energy is applied to ablate perivascular nerves, then nerve modulation effectiveness is improved, but adjacent tissue damage increases
Solution Approach 1:
The balloon is designed with RF-permeable sections at specific locations to deliver radiofrequency energy locally to target nerves while non-permeable sections provide insulation to protect adjacent tissues. This spatial differentiation of material properties enables selective energy delivery to the intended target while minimizing collateral damage to surrounding structures.
Solution Approach 2:
A conductive fluid is introduced into the balloon to serve as an intermediary medium that transmits RF energy from the electrode to the target nerves. The fluid enhances energy coupling and distribution, allowing for more precise and controlled energy delivery while reducing direct contact between the electrode and tissue, thereby minimizing unwanted thermal spread to adjacent areas.
2Reliability
If RF energy is delivered to achieve sufficient heating for nerve ablation, then nerve ablation effectiveness is improved, but temperature control precision deteriorates
Solution Approach 1:
The system utilizes hydraulic principles by circulating conductive fluid through the balloon to achieve active cooling. The fluid flow rate and temperature can be controlled to precisely regulate the thermal environment, allowing the tissue to be heated to effective ablation temperatures while preventing excessive temperature rise that would compromise control precision or damage adjacent structures.
Solution Approach 2:
The ablation process employs periodic RF energy delivery interspersed with cooling intervals during which conductive fluid is circulated through the balloon. This alternating pattern of heating and cooling allows for controlled accumulation of therapeutic thermal effects while preventing uncontrolled temperature escalation, thereby maintaining temperature control precision throughout the procedure.
3Manufacturing precision
If a balloon structure is used to contain conductive fluid for energy transmission, then energy delivery precision is improved, but device complexity increases
Solution Approach 1:
The balloon is segmented into distinct RF-permeable and non-permeable sections, with permeable portions positioned at locations requiring energy delivery and non-permeable portions providing structural support and insulation. This segmentation allows the complex functionality of selective energy transmission to be achieved through a modular design that can be manufactured using standard balloon fabrication techniques.
Solution Approach 2:
The conductive fluid serves multiple functions simultaneously: it acts as a cooling medium to prevent overheating, as an energy transmission medium to couple RF energy from the electrode to the target tissue, and as a contrast agent for imaging guidance. This multi-functionality reduces the need for additional separate components, thereby limiting the increase in device complexity despite the sophisticated energy delivery capabilities.
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
This solution enables effective modulation and ablation of renal nerves with reduced tissue damage by localized energy delivery and cooling, improving procedural efficacy and safety.
Implementation Method 1
at least one section of the balloon is permeable to radiofrequency (RF) radiation and extends from the interior surface of the balloon to the exterior surface of the balloon
Implementation Method 2
A cooling arrangement is configured for one of receiving a thermal transfer fluid from the lumen arrangement or facilitating perfusion of blood passing through the target vessel to cool the balloon body during ablation of perivascular tissues
Data Source
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Figure 3A
AI summary
An intravascular catheter and related methods of use or manufacture are disclosed. The catheter includes an outer tubular member having a proximal end and a distal end, and an inner tubular member having a proximal end and a distal end. An inflatable balloon have a proximal end waist coupled to the outer tubular member adjacent to the distal end thereof, and a distal end waist coupled to the inner tubular member adjacent to the distal end thereof. The balloon includes an interior surface, an exterior surface, and a lumen defined by the interior surface. The balloon further includes at least one section extending from the interior surface of the balloon to the exterior surface of the balloon. A transmitter is disposed about the inner tubular member. In addition to the above, the proximal end waist is coupled to the outer tubular member such that an inflation fluid exits the balloon.