Imaging Catheter Support Member for Pushability Without Artifacts
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Solution Overview
Problem
Existing intravascular imaging catheters face challenges in enhancing pushability, kink resistance, and robustness, particularly when used with smaller guidewires, and often suffer from imaging artifacts due to the presence of support structures.
Innovation Solution
The design incorporates a core wire or support member within the catheter shaft, aligned radially and circumferentially with the guidewire lumen, providing structural support while minimizing visibility in imaging procedures by aligning with the guidewire, and using materials like stainless steel or nickel-titanium alloys for enhanced pushability and kink resistance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a support member is added to enhance pushability and kink resistance, then structural robustness is improved, but imaging artifacts increase
Solution Approach 1:
The support member is merged with the guidewire lumen structure, where the support member is disposed within the wall of the elongate sheath and aligned with the guidewire lumen. This integration allows the support member to provide structural reinforcement while being positioned to minimize interference with imaging planes, thus reducing imaging artifacts while maintaining pushability.
Solution Approach 2:
The support member acts as an intermediary element that provides mechanical support (pushability and kink resistance) while being strategically positioned within the sheath wall rather than as a separate external component. This intermediary positioning allows it to provide structural integrity without directly interfering with the imaging path, thus resolving the contradiction between strength and imaging quality.
2Stability of the object's composition
If a support member is added to improve kink resistance, then catheter robustness is enhanced, but device complexity increases
Solution Approach 1:
The support member is combined with the existing sheath structure by disposing it within the wall of the elongate sheath. This merging approach integrates the kink resistance function into the existing catheter architecture rather than adding a separate external component, thereby enhancing robustness while minimizing the increase in overall device complexity.
Solution Approach 2:
The support member serves multiple functions: it provides kink resistance, enhances pushability, and maintains structural integrity of the catheter. By consolidating these functions into a single integrated component within the sheath wall, the design achieves multi-functionality without proportionally increasing device complexity.
3Object-generated harmful factors
If the core wire is aligned with the guidewire lumen, then imaging artifacts are reduced, but manufacturing precision requirements increase
Solution Approach 1:
The core wire (support member) is merged with the guidewire lumen structure by disposing it within the sheath wall in alignment with the lumen. This integrated design ensures that the support member naturally follows the guidewire path, reducing misalignment and minimizing imaging artifacts while providing a manufacturable solution that incorporates alignment features during the molding process.
Data Source
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AI summary
Medical devices and methods for making and using medical devices are disclosed. The medical device is an intravascular imaging catheter. The intravascular imaging catheter includes an elongate sheath having a distal tip region. The distal tip region includes a first port, a second port, and a guidewire lumen extending between the first port and the second port. A core wire or support member is disposed within the elongate sheath along the distal tip region, and an imaging core is disposed within the elongate sheath.