Flexible Circuit Assemblies for Sympathetic Nerve Modulation
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Solution Overview
Problem
Existing medical devices for sympathetic nerve modulation, such as those used for renal nerve ablation, face challenges in withstanding forces during withdrawal and repositioning, leading to potential damage and delamination of electrode assemblies.
Innovation Solution
The design incorporates a flexible circuit assembly with a polymer substrate featuring a tapered region and canted configuration, including electrode strips and sensor strips, which allows for reduced force exposure and easier refolding of the balloon, minimizing damage during device repositioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid electrode assembly is used for sympathetic nerve modulation, then the device provides stable electrical contact and reliable electrode positioning, but the device is susceptible to damage and delamination during withdrawal and repositioning due to mechanical forces
Solution Approach 1:
The electrode assembly is constructed with flexible circuit boards and thin film electrodes that can bend and flex without breaking. This allows the rigid electrode contacts to maintain stable electrical connection while the flexible substrate absorbs mechanical stresses during device withdrawal and repositioning, preventing delamination and damage.
Solution Approach 2:
The device combines rigid electrode contact elements with flexible circuit substrates and compliant mounting structures. This composite construction provides both the stable electrical contact of rigid materials and the mechanical flexibility of soft materials, resolving the contradiction between contact stability and damage resistance.
2Manufacturing precision
If a complex electrode assembly structure is used to ensure proper electrode positioning and orientation, then the device achieves precise sympathetic nerve modulation, but the device complexity increases making it more difficult to manufacture and more susceptible to damage
Solution Approach 1:
The electrode assembly is divided into modular segments with standardized connectors and mounting interfaces. This segmentation allows precise positioning to be achieved through modular assembly rather than complex monolithic structures, simplifying manufacturing and reducing susceptibility to damage while maintaining positioning accuracy.
Solution Approach 2:
The flexible circuit board serves multiple functions: it provides structural support, enables precise electrode positioning through its rigidity, allows bending for device repositioning, and incorporates conductive traces for electrical connections. This multi-functionality reduces overall device complexity while maintaining manufacturing precision.
Data Source
AI summary
Medical devices for sympathetic nerve modulation are disclosed. An example medical device for sympathetic nerve modulation may include a catheter shaft having a distal region. An expandable member may be coupled to the distal region. A flexible circuit assembly may be attached to the expandable member. The flexible circuit assembly may include a first electrode strip, a second electrode strip, and a sensor strip disposed between the first electrode strip and the second electrode strip. The first electrode strip may include a first electrode. The second electrode strip may include a second electrode. The first electrode and the second electrode may define a pair of bipolar electrodes.