IVUS Flexible Substrate Recess Layout for Catheter Flexibility
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Solution Overview
Problem
Existing solid-state IVUS catheters face challenges with electrical cable attachment near electronic components, leading to potential harm and increased stiffness, making it difficult to navigate tortuous vasculature, and the manufacturing process is hard to automate due to flex circuit thickness variations.
Innovation Solution
A flexible substrate with recesses in the proximal portion to maintain flexibility, allowing efficient transition from a flat to a rolled configuration, and includes a thicker layer for conductive trace protection, with recesses extending completely through the substrate to counteract stiffness without interfering with device operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the proximal portion of the flexible substrate includes an additional layer to protect conductive traces, then the protection of conductive traces is improved, but the flexibility of the substrate deteriorates due to increased thickness
Solution Approach 1:
The substrate has different structures in different regions: the distal portion has a single layer for flexibility and acoustic element mounting, while the proximal portion has a multi-layer construction with recesses for trace protection. This local differentiation allows each region to optimize its properties for its specific function.
Solution Approach 2:
The recesses create a porous or hollow structure in the proximal portion of the substrate. By removing material to form cavities, the substrate maintains flexibility despite the additional protective layers, as the recesses reduce the overall material density and allow bending.
2Device complexity
If the electrical cable is attached close to electronic components, then the device complexity is reduced, but the electronic components may be harmed and the catheter stiffness increases
Solution Approach 1:
The cable attachment point is extracted or separated from the electronic components by positioning it at the proximal portion of the substrate, away from the distal portion where electronic components are located. This spatial separation prevents harm to components while maintaining relative simplicity in the connection approach.
3Device complexity
If the cable connection increases the stiff length at the distal portion, then the electrical interface is simplified, but the catheter's ability to traverse tortuous vasculature is reduced
Solution Approach 1:
The substrate exhibits different mechanical properties in different regions: the distal portion is designed with single-layer construction for maximum flexibility to navigate tortuous vasculature, while the proximal portion has additional layers for protection and cable attachment. This local differentiation allows the catheter to maintain overall flexibility while providing structural support where needed.
4Reliability
If the flex circuit has added thickness in some portions, then the conductive traces are protected, but the manufacturing automation becomes difficult due to thickness variations
Solution Approach 1:
The recesses create a consistent porous structure in the proximal portion that can be manufactured using standardized processes. By designing the recesses with uniform dimensions and patterns, the thickness variations become predictable and controllable, enabling automated manufacturing while still providing trace protection.
Data Source
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AI summary
An intraluminal imaging device includes a flexible elongate member configured to be positioned within a body lumen of a patient, the flexible elongate member comprising a proximal portion and a distal portion; an ultrasound imaging assembly disposed at the distal portion of the flexible elongate member, the ultrasound imaging assembly comprising: a flexible substrate comprising: a proximal portion comprising a plurality of recesses extending completely through the flexible substrate from a first surface to an opposite, second surface; and a distal portion comprising a plurality of acoustic elements; a support member around which the distal portion of the flexible substrate is positioned; and a plurality of conductors extending along a length of the flexible elongate member and coupled to the proximal portion of the flexible substrate such that the plurality of conductors are in communication with the plurality of acoustic elements.