Shapeable Guiderail Catheter for Coronary Sinus Access
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Solution Overview
Problem
Current medical procedures for introducing devices into the coronary sinus, such as pacemaker leads and catheters, are time-consuming and difficult due to anatomical variations and the inability of fixed shape catheters to adapt to individual patient anatomy, leading to increased procedure time and risk.
Innovation Solution
A shapeable guiderail catheter with a biocompatible polymer coating and radiopaque markers, capable of being customized to fit specific patient anatomy, is used to facilitate the introduction of sheaths and pacing therapy devices into the coronary sinus, allowing for efficient and precise placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If fixed shape catheters are used to access the coronary sinus, then the catheter structure is simple and easy to manufacture, but the procedure time increases and success rate decreases due to inability to adapt to anatomical variations
Solution Approach 1:
The catheter shaft is constructed with shapeable sections that allow the operator to dynamically adjust the catheter's curvature and configuration to match the patient's specific coronary sinus anatomy. This dynamic adaptability reduces procedure time and increases success rate while maintaining manufacturing simplicity through modular construction.
Solution Approach 2:
The catheter incorporates shapeable sections with adjustable physical parameters (curvature, length, orientation) that can be modified during the procedure to accommodate varying anatomical conditions. This allows the same catheter design to be adapted to different patients without increasing manufacturing complexity.
2Device complexity
If fixed shape catheters are used, then the device design is simple, but the adaptability to individual patient anatomy is poor
Solution Approach 1:
The catheter features shapeable sections that transition from a fixed design to a dynamically adaptable configuration during use. The operator can manipulate these sections to create custom curves and angles, providing high anatomical adaptability while maintaining a relatively simple base design that is easy to manufacture.
Solution Approach 2:
The catheter is divided into distinct segments including a shapeable section, a rigid distal tip, and a flexible proximal portion. This segmentation allows the different parts to serve specialized functions while maintaining overall design simplicity and manufacturability.
3Speed
If stylets are used to stiffen flexible medical devices, then the device can be advanced through vasculature, but the device flexibility is reduced and damage risk increases
Solution Approach 1:
The catheter is pre-formed with appropriate curves and shapes that facilitate navigation through the vasculature and into the coronary sinus without requiring stylets. This preliminary configuration provides the necessary structural support for advancement while maintaining device flexibility and reducing damage risk.
Solution Approach 2:
The catheter utilizes a flexible shaft construction with controlled rigidity that provides sufficient support for navigation while maintaining the flexibility needed to prevent vasculature damage. The shapeable sections allow the operator to optimize the balance between support and flexibility for each patient's anatomy.
Data Source
AI summary
A system and method for positioning sheaths into the Coronary Sinus using a guiderail catheter.