Lockable Balloon Catheter for Intravascular Guidewire Stability
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Solution Overview
Problem
Conventional intravascular procedures face challenges with guidewire instability, leading to uncontrollable motion and increased risk of vessel damage during stent delivery, especially in tortuous or calcified vessels, necessitating multiple equipment exchanges and potential re-intervention.
Innovation Solution
A lockable balloon catheter with a controllable locking mechanism that anchors and stabilizes the guidewire near the target site, allowing for secure delivery of additional components by inflating and deflating the balloon to lock onto the guidewire, enhancing guidewire stability and reducing equipment exchanges.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional guidewire procedures are used without locking mechanism, then the procedure is simpler, but guidewire stability deteriorates leading to uncontrollable motion and vessel damage risk
Solution Approach 1:
The balloon catheter is nested over the guidewire, with the balloon able to collapse around the guidewire to create a locking mechanism. This nested configuration allows the balloon to transition between a delivery state (where it can be advanced over the guidewire) and a locked state (where it stabilizes the guidewire at the target site), resolving the contradiction between procedural simplicity and guidewire stability.
Solution Approach 2:
The balloon catheter transitions between different states (deflated for delivery, inflated for locking) to dynamically adapt its function. This dynamic state change allows the system to provide guidewire stabilization only when needed at the target site, maintaining procedural simplicity during delivery while ensuring reliability during the intervention.
2Object-affected harmful factors
If guidewire stability is enhanced through locking mechanism, then vessel damage risk is reduced, but equipment exchanges increase
Solution Approach 1:
The balloon catheter is pre-positioned and locked to the guidewire at the target site before the actual intervention begins. This preliminary locking action stabilizes the guidewire in advance, preventing uncontrollable motion and vessel damage during subsequent device delivery, thereby reducing the need for corrective equipment exchanges and re-interventions.
3Ease of operation
If balloon catheter is locked to guidewire, then delivery of additional components is facilitated, but guidewire mobility is restricted
Solution Approach 1:
The locking mechanism is applied locally at the target site rather than along the entire guidewire length. The balloon locks the guidewire only at the specific location where intervention is needed, while the distal and proximal portions of the guidewire retain their natural mobility for navigation and device delivery, thus facilitating component delivery without compromising guidewire position stability at the critical site.
Data Source
AI summary
Intravascular delivery system for deployment of a therapeutic device (such as a stent, and/or other therapeutic devices including balloon catheter(s), laser catheter(s), intravascular ultrasound (IVUS), Optical coherence tomography (OCT), drug delivery catheter(s), coil delivery catheter(s), etc.) as required by a particular surgical procedure, in a controlled and robust manner is supported by a lockable balloon catheter equipped with a locking mechanism configured to lock in vivo to a delivery component, such as a guidewire. The lockable balloon catheter can be controllably transitioned between locked and unlocked modes of operation by inflation/deflation of the balloon of the lockable balloon catheter. The system provides an enhanced interlocking interface between the delivery component and an inner shaft by a unique configuration of the inner shaft. Connection of the inner shaft/guidewire and/or outer shaft/inflation lumen to the balloon is by an extended “neck” at the end(s) of the balloon which snuggly envelopes the portions of the inner and/or outer shaft(s) entering/exiting the balloon, thus avoiding the bonding and simplifying fabrication process. Being in the locked mode of operation, the lockable balloon catheter facilitates delivery of the therapeutic device along the delivery component to a target site while enhancing the stability of the delivery component, especially near the target site.