Cooled RF Balloon Catheter for Nerve Lesion Depth Control
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Solution Overview
Problem
Minimally invasive procedures for nerve and soft tissue treatment, such as rhizotomy, face challenges in achieving effective nerve destruction due to radiofrequency current dissipation and control of bleeding, leading to inefficient tissue cutting and potential thermal damage.
Innovation Solution
A cooled RF balloon catheter system with expandable members and electrodes is used to create a larger lesion volume, employing active or passive cooling to enhance nerve disruption and pain relief, while maintaining control over bleeding through RF energy and cooling mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radiofrequency current is applied to destroy nerves, then nerve destruction is achieved, but radiofrequency current dissipation occurs leading to inefficient tissue cutting
Solution Approach 1:
The patent transitions from point-contact electrodes to a surface-area balloon contact interface, changing the dimensional approach of RF energy delivery. The inflatable balloon creates a distributed contact surface that reduces current density and dissipation while maintaining effective nerve destruction through expanded thermal field coverage.
Solution Approach 2:
The balloon structure serves multiple functions simultaneously: it provides a large contact area for RF energy delivery, acts as a thermal conduit for cooling fluid circulation, and creates uniform tissue compression. This multi-functionality addresses energy dissipation by combining expanded surface area with active cooling to maintain efficient energy transfer.
2Reliability
If radiofrequency energy is used for nerve destruction, then pain relief is achieved, but thermal damage and bleeding control become problematic
Solution Approach 1:
The patent actively changes the temperature parameter by introducing cooling fluid circulation through channels in the balloon wall. This allows the RF energy to be delivered at controlled temperature levels, preventing excessive thermal damage and bleeding while maintaining effective nerve lesioning through controlled thermal fields.
Solution Approach 2:
The cooling fluid acts as an intermediary substance between the RF energy source and the surrounding tissue. It absorbs excess heat from the balloon-tissue interface, preventing uncontrolled thermal damage and bleeding while allowing the RF energy to effectively destroy target nerves through controlled thermal mechanisms.
3Volume of moving object
If a larger contact area is used for RF delivery, then lesion depth and duration increase, but device complexity increases due to cooling mechanisms
Solution Approach 1:
The patent merges the RF energy delivery function with the cooling function into a single integrated balloon structure. The balloon wall contains internal cooling channels that circulate fluid while the outer surface delivers RF energy, combining multiple functions in one component to achieve large lesion volume without proportionally increasing overall device complexity.
Solution Approach 2:
The cooling channels are nested within the balloon wall structure, with the cooling fluid pathway embedded inside the balloon material itself. This nesting approach allows the cooling mechanism to be contained within the existing balloon structure, minimizing additional complexity while enabling active temperature control for deeper, longer-lasting lesions.
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 cooled RF balloon catheter system effectively increases the depth and duration of nerve lesions, improving pain relief and treatment efficacy while minimizing thermal damage and bleeding control.
Implementation Method 1
A cooling mechanism is configured to cool the inflation material so as to cool the tissue that the balloon comes in contact. Cooling the tissue will in turn increase the depth of the lesion.
Implementation Method 2
Such radio frequency nerve lesioning results in five to eight or more months of pain relief before the nerve regenerates
Data Source
AI summary
A device for performing a surgical procedure comprises an elongated shaft extending between a proximal end and a distal end and defines an outer surface and an inner surface. An expandable member is disposed at the distal end and is configured to receive inflation material. At least one electrode is disposed with the inflatable member. A cooling mechanism is configured to cool surrounding tissue that the device comes in contact.