Vascular Access System With Bypass Channel For Zone Isolation
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Solution Overview
Problem
Current medical procedures face challenges in accessing the wall of vascular structures or body lumens while simultaneously providing zone isolation and fluid bypass capabilities, especially when dealing with therapies that require controlled pressure and fluid presence or absence, and the need to prevent debris from flowing downstream.
Innovation Solution
An access system comprising erectable proximal and distal isolation barriers, a bypass channel, and a working catheter that allows for zone isolation and fluid bypass, enabling controlled access to the wall of the body lumen while maintaining blood flow through the isolated segment, and is mountable on a guidewire for delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If zone isolation is provided using traditional methods (e.g., clamps, sutures, or occlusion devices), then the therapy zone can be isolated from the remainder of the vascular structure, but blood flow through the isolated segment is interrupted and debris may still flow downstream
Solution Approach 1:
The isolation system is divided into two separate barriers: a proximal isolation barrier and a distal isolation barrier. These barriers segment the vascular structure into three zones: an isolated zone between the barriers where therapy is applied, a proximal zone upstream of the proximal barrier, and a distal zone downstream of the distal barrier. This segmentation allows the isolated zone to be separated for therapy while maintaining flow through the other zones via the bypass channel.
Solution Approach 2:
A bypass channel acts as an intermediary pathway that extends from the proximal isolation barrier to the distal isolation barrier. This channel provides an alternative route for blood flow to bypass the isolated zone, allowing continuous flow through the vascular structure while the isolated zone remains sealed off for therapy application. The bypass channel mediates between the isolation function and the flow continuity requirement.
2Ease of manufacture
If the wall of the vascular structure is accessed for therapy application, then curative therapies can be applied directly to the target site, but debris generated during therapy may flow downstream and cause complications
Solution Approach 1:
The proximal and distal isolation barriers are deployed in advance to create a sealed isolated zone before therapy is applied to the vascular wall. This preliminary isolation prevents debris generated during subsequent therapy procedures from escaping into the downstream circulation. The barriers establish a protective boundary that counteracts the potential harmful effect of debris flow before the therapy begins.
3Ease of operation
If pressure and fluid control is needed within the isolation zone for therapy application, then medical instruments and therapies can be effectively applied, but the system complexity increases
Solution Approach 1:
The isolated zone created by the proximal and distal barriers serves multiple functions: it provides a sealed environment for therapy application, allows pressure and fluid control, prevents debris downstream flow, and maintains overall blood flow continuity through the bypass channel. This multi-functionality reduces the need for additional separate systems, thereby managing complexity while providing comprehensive control capabilities.
Data Source
AI summary
Apparatus and method for accessing the wall of a body lumen while simultaneously providing zone isolation and fluid bypass capability, the apparatus comprising:an erectable proximal isolation barrier capable of making a sealing engagement with the wall of the body lumen;an erectable distal isolation barrier capable of making a sealing engagement with the wall of the body lumen;a bypass channel secured to, and extending between, the proximal isolation barrier and the distal isolation barrier, the bypass channel comprising a lumen communicating with the region proximal to the proximal isolation barrier and with the region distal to the distal isolation barrier; anda working catheter passing through the proximal isolation barrier and terminating short of the distal isolation barrier, the working catheter providing a central lumen for providing access to the wall of the body lumen between the proximal isolation barrier and the distal isolation barrier.