Extravascular Bypass Stent System for Occlusion Management
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Solution Overview
Problem
Current methods for bypassing occlusions in blood vessels face challenges in accurately locating and maintaining the position of catheters, especially between larger veins and smaller arteries, leading to inefficiencies in restoring blood flow and preventing complications like critical limb ischemia and amputation.
Innovation Solution
The development of an extravascular bypass system using stents with specific inlet and outlet configurations, along with a kit for implantation, which includes sheaths and a percutaneous tunneler, to create a bypass channel outside the blood vessels, allowing blood to flow from one vessel to another while avoiding the occlusion, thereby enhancing blood flow to peripheral regions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a catheter is used to create a fistula between two blood vessels, then blood flow can be restored by bypassing the occlusion, but it is difficult to accurately co-locate the openings in the two vessels and maintain catheter position
Solution Approach 1:
The patent uses a delivery system with a positioning mechanism as an intermediary to facilitate accurate catheter placement. The delivery system includes a positioning element that can be adjusted to match the geometry of both vessels, enabling precise co-location of openings without requiring direct manual positioning of the catheter itself.
Solution Approach 2:
The patent employs preliminary positioning actions by providing a delivery system that pre-configures the catheter position before actual blood flow restoration. The positioning mechanism is adjusted and secured in advance to ensure accurate alignment of vessel openings, preventing positioning errors during the critical blood flow restoration phase.
2Reliability
If a catheter is introduced into a larger vein to reach a smaller artery, then blood flow can be bypassed, but the larger vein allows too much freedom of movement for the catheter
Solution Approach 1:
The delivery system acts as an intermediary between the operator and the catheter, providing control mechanisms that compensate for the freedom of movement in larger veins. The positioning mechanism includes adjustable elements that can be fine-tuned to secure the catheter in the desired position within the vein, maintaining control despite the vein's larger diameter.
Solution Approach 2:
The patent applies local quality by providing different structural characteristics at different locations of the delivery system. The positioning mechanism has localized control features that can be adjusted independently to match the specific geometry and movement characteristics of the vein at the implantation site, improving catheter control without affecting the overall bypass function.
Data Source
AI summary
Systems and methods are provided for extravascularly bypassing an occlusion within a patient's blood vessel. An upstream bypass stent may be implanted at an implant site upstream of the occlusion and a downstream bypass stent may be implanted at an implant site downstream of the occlusion, wherein an outlet of the upstream stent and an inlet of the downstream stent are coupled extravascularly to permit blood to extravascularly bypass the occlusion. The upstream stent further may include an additional outlet that directs blood to flow through the occluded blood vessel. A kit including a percutaneous tumescence tunneler for implanting the extravascular bypass system is also provided.