Tapered Micro-Catheter Intravascular Delivery System for Lesion Reachability
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Solution Overview
Problem
Conventional guide extension devices for coronary arteries face challenges in delivering pre-dilatation balloons and stents due to their large, blunt distal ends, which limit their ability to reach and treat lesions effectively, especially in tortuous or calcified vessels, and lack a seamless interface between inner and outer catheter members for atraumatic passage.
Innovation Solution
A minimally invasive intravascular delivery system featuring a coaxial, highly flexible tapered micro-catheter with a pre-dilatation balloon attached, integrated within an outer delivery sheath, allowing for seamless passage and controlled advancement beyond the lesion site, utilizing a locking mechanism for integral motion and retraction to facilitate stent deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional guide extension devices with large, blunt distal ends are used, then structural stability is maintained, but deliverability to lesions in tortuous or calcified vessels is limited
Solution Approach 1:
The guide extension device is divided into two distinct segments: an outer guide catheter and an inner deliverable component. This segmentation allows the outer catheter to provide structural stability while the inner component with its tapered micro-catheter delivers the interventional device to the lesion site, resolving the contradiction between stability and deliverability.
Solution Approach 2:
Instead of using a conventional blunt distal end, the invention inverts the approach by employing a tapered micro-catheter at the inner component's distal end. This inverted geometry enables atraumatic passage through tortuous or calcified vessels while maintaining the necessary structural support from the outer guide catheter.
2Object-affected harmful factors
If a tapered micro-catheter is used for atraumatic delivery, then passage through vessels is smoother, but the device complexity increases
Solution Approach 1:
The inner component with the tapered micro-catheter is nested within the outer guide catheter, creating a coaxial structure. This nesting arrangement allows the delicate tapered micro-catheter to provide atraumatic delivery while the outer catheter provides structural support and guidance, managing the complexity through functional integration.
Solution Approach 2:
The outer guide catheter serves multiple functions: it provides structural stability, acts as a delivery conduit for the inner component, and offers guidance through the vessel. This multi-functionality reduces the need for separate components, thereby managing device complexity while achieving atraumatic delivery.
3Ease of operation
If the inner member is freely movable within the outer member, then ease of retraction is improved, but control over forward displacement is lost
Solution Approach 1:
The interconnection mechanism provides dynamic control, allowing the inner component to be locked in position during delivery for reliability, and unlocked for controlled retraction when needed. This dynamic switching between fixed and movable states resolves the contradiction between position stability and retraction ease.
Solution Approach 2:
The interconnection mechanism acts as an intermediary between the inner and outer members, mediating the relationship between them. It enables controlled engagement and disengagement, allowing the system to transition between stable locked positions and movable retraction modes as required by the procedure.
4Object-affected harmful factors
If a seamless interface is created between inner and outer members, then atraumatic passage is achieved, but manufacturing precision requirements increase
Solution Approach 1:
The seamless interface is created locally at the distal end of the inner component where it contacts the vessel wall, while the proximal portions maintain standard manufacturing tolerances. This localized application of high precision only where needed reduces overall manufacturing complexity while achieving atraumatic passage through the vessel.
Data Source
AI summary
The subject guide catheter extension/pre-dilatation system includes an outer delivery sheath, an inner member extending within the sheath, and a mechanism for engagement/disengagement of the inner member to/from the sheath. The inner member is configured with a tapered distal tip having a delivery micro-catheter and a pre-dilatation balloon member attached to the tapered distal tip. The guidewire and a guide catheter are advanced to the vicinity of the treatment site within a blood vessel. Subsequently, the inner member and outer delivery sheath, in their engaged configuration, are advanced along the guidewire inside the guide catheter towards the site of treatment. At the treatment site, the balloon member is inflated for pre-dilatation treatment. The inner member is disengaged and retracted from the outer delivery sheath, and a stent is delivered to the treatment site.


