Blunt Dissection Catheter for Crossing Vascular Occlusions
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Solution Overview
Problem
Conventional guide wires are inadequate for generating pathways through total vascular occlusions, as they are not robust enough to navigate through occlusive material without perforating the vessel wall, and existing interventional methods for treating total occlusions are challenging and risky, often requiring surgical intervention.
Innovation Solution
A catheter system comprising a Blunt Dissection Catheter and a Sheath Catheter, where the Blunt Dissection Catheter uses remotely actuated atraumatic spreading members to create a dissection track through the occlusion, and the Sheath Catheter provides support and lubricity to facilitate the Blunt Dissection Catheter's advancement, allowing for the generation of an initial pathway through the occlusion without causing vessel perforation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional guide wires are used to navigate through total vascular occlusions, then the guide wire can be advanced through non-occluded vessels, but the guide wire cannot generate a pathway through the occlusive material without risking vessel wall perforation
Solution Approach 1:
The guide wire is segmented into a flexible distal termination for navigation and a more robust intermediate section for pathway generation. This segmentation allows the wire to be soft enough to navigate tortuous vessels safely while having sufficient body to push through occlusive material without perforating the vessel wall.
Solution Approach 2:
Different sections of the guide wire have different mechanical properties tailored to their specific functions. The distal tip is highly flexible and atraumatic for vessel navigation, while the intermediate section has increased rigidity and pushability for penetrating occlusions, and the proximal section provides torque control and stability for operator manipulation.
2Ease of operation
If a more robust guide wire is used to push through occlusive material, then pathway generation improves, but the risk of vessel wall perforation increases
Solution Approach 1:
The guide wire incorporates dynamic flexibility along its length, with the distal section being highly flexible to conform to vessel anatomy and the intermediate section becoming progressively stiffer to provide pushability. This dynamic gradient allows the wire to bend safely around corners while maintaining the force needed to penetrate occlusions without excessive rigidity that could cause perforation.
Solution Approach 2:
The guide wire acts as an intermediary between the operator's manipulation at the proximal end and the interaction with the occlusive material at the distal end. Its graduated stiffness profile allows it to mediate between the need for force transmission to break through occlusions and the need for flexibility to follow vessel contours and avoid perforation.
3Reliability
If surgical intervention is used to treat total occlusions, then complete recanalization can be achieved, but the treatment becomes more invasive with longer recovery time
Solution Approach 1:
The guide wire performs preliminary action by creating an initial pathway through the total occlusion before larger therapeutic devices can be delivered. This preliminary channel formation enables subsequent minimally invasive procedures such as balloon angioplasty or stent placement to be performed through the same access, avoiding the need for more invasive surgical bypass procedures.
Data Source
AI summary
Interventional catheter-based systems and methods are described herein for use in generating an initial pathway through vascular occlusions. The catheter systems generally include two elements. A first element is a Blunt Dissection Catheter including a manually actuated assembly located at the distal tip of the Blunt Dissection Catheter that performs blunt dissection in the vascular occlusion to produce a dissection track, or small pathway through the occlusion. The second element is a Sheath Catheter that serves as a conduit within which the Blunt Dissection Catheter is freely advanced, retracted and rotated. The first and second elements are used in some combination to cross vascular occlusions in both the coronary and peripheral vasculature.