Guide Extension Catheter With Removable Stiffener
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Solution Overview
Problem
Current intracorporeal medical devices face challenges in maintaining stable positioning during minimally-invasive cardiac interventions, particularly in coronary arteries, due to shifting guide catheters caused by heart movement or other factors, which hinders efficient access for treatment catheters.
Innovation Solution
A guide extension catheter system comprising a proximal member with a removable stiffening member and a distal sheath member, where the distal sheath member has a larger outer diameter than the proximal member, allowing it to extend beyond the distal end of the guide catheter into the coronary artery, stabilizing the guide catheter's position and facilitating access for therapeutic catheters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a guide catheter is used for minimally-invasive cardiac interventions, then access to coronary arteries is achieved, but the guide catheter position becomes unstable due to heart movement
Solution Approach 1:
The guide catheter system is divided into two separate components: the original guide catheter and an extension catheter. The extension catheter can be independently advanced into the coronary artery to provide stability while the main guide catheter maintains access capability. This segmentation allows each component to fulfill its specific function without compromising the other.
Solution Approach 2:
The extension catheter acts as an intermediary element between the guide catheter and the coronary artery. It extends beyond the guide catheter's distal end to engage the coronary artery ostium, serving as a mediator that stabilizes the system while allowing the guide catheter to maintain its access function.
2Stability of the object's composition
If the guide catheter is made more stable by increasing its size, then positioning stability improves, but access through existing guide catheters becomes difficult
Solution Approach 1:
The extension catheter is designed to be nested within or advanced through the guide catheter. The extension catheter's profile is sufficiently small to pass through the guide catheter's lumen, yet it provides the necessary stability when deployed. This nesting approach allows a small stabilizing component to be delivered through a larger access-critical component.
Solution Approach 2:
Stability is provided locally at the coronary artery ostium by the extension catheter rather than requiring the entire guide catheter to be enlarged. The extension catheter's distal portion engages the ostium to provide localized stabilization, while the proximal guide catheter maintains its original size for easy access.
3Ease of operation
If a removable stiffening member is added to the guide extension catheter, then delivery flexibility improves, but device complexity increases
Solution Approach 1:
The stiffening member is pre-positioned within the extension catheter during manufacturing. It is designed to be automatically deployed or easily activated during the delivery process, eliminating the need for complex real-time adjustments. This preliminary preparation simplifies the delivery operation while maintaining flexibility.
Solution Approach 2:
The stiffening member provides dynamic adjustability to the extension catheter's mechanical properties. It can be engaged or disengaged based on the delivery stage: engaged during delivery for pushability, and disengaged during positioning for flexibility. This dynamic characteristic allows the device to adapt its properties to different operational requirements.
Data Source
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AI summary
Medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter (114) may include a proximal member (116) having a proximal outer diameter. A removable stiffening member (146) may be disposed adjacent to the proximal member. A distal sheath member (126) may be attached to the proximal member. The distal sheath member may have a distal outer diameter greater than the proximal outer diameter.