Self-aligning Radiopaque Ring for Intravascular Recapture
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Solution Overview
Problem
Intravascular procedures, such as heart valve repair, face challenges in precise placement and recapture of medical devices like the mitral clip due to limitations in current steerable guide catheter systems, which can lead to complications and difficulties in repositioning or redeployment.
Innovation Solution
A steerable guide catheter system with a ring having a specific geometry, including a face radius to body radius ratio of 1.20 to 1.75 and a guide surface forming an angle of 100° to 160°, facilitates the alignment and recapture of medical devices by allowing self-alignment within the catheter, preventing contact with the catheter tip and enabling reliable coaxial or radial alignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a conventional steerable guide catheter system is used, then the catheter can be directed to the heart through the patient's vasculature, but the distal end of the catheter cannot be precisely controlled or reliably recaptured
Solution Approach 1:
The ring component is designed with a spherical geometry featuring a face with radius R1 and a body with radius R2, where the ratio R1/R2 falls within 1.20 to 1.75. This spherical configuration enables the ring to self-align coaxially within the guide catheter, providing precise positioning and stable recapture of the distal end without requiring complex control mechanisms.
Solution Approach 2:
The ring's geometric design allows it to automatically align itself coaxially within the guide catheter through its own shape characteristics. The specific radius ratio creates a self-centering effect where the ring naturally positions itself without external intervention, achieving precise positioning through self-alignment rather than active control.
2Adaptability or versatility
If the distal end of the catheter is deflected to reach the left atrium, then access to the mitral valve is achieved, but precise control and positioning become difficult
Solution Approach 1:
The spherical ring geometry with optimized radius ratio provides a stable reference structure that maintains precise positioning even when the catheter is deflected to access the left atrium through the intra-atrial septum. The curved spherical surfaces facilitate smooth navigation while the geometric constraints ensure accurate final positioning.
3Reliability
If the moveable arms of the mitral clip contact the tip or exterior of the SGC, then recapture is limited or prevented, but avoiding contact requires precise control
Solution Approach 1:
The ring acts as an intermediary component between the mitral clip and the guide catheter. By providing a dedicated recapture structure with the spherical geometry, the ring mediates the interaction between the clip arms and catheter, guiding the arms away from direct contact with the catheter tip while maintaining reliable recapture functionality.
Solution Approach 2:
The spherical shape of the ring with its specific radius ratio creates a geometric configuration that naturally guides the moveable arms of the mitral clip away from the catheter tip during recapture. The curved surfaces provide a smooth pathway that prevents harmful contact while maintaining control.
Data Source
AI summary
An intravascular device configured to be recaptured within a guide catheter has a ring located at the distal end of a delivery catheter. The ring has an outer diameter greater than that of the delivery catheter and a sloped guide surface near the outer edge of the ring to urge the ring and delivery catheter toward a radially centered position within the guide catheter.