External Vascular Support for Hemodialysis Anastomosis
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Solution Overview
Problem
Vascular access dysfunction in hemodialysis patients is primarily caused by early maturation failure and late venous stenosis due to neointimal hyperplasia, leading to anastomotic dysfunction and luminal stenosis, which existing methods fail to effectively prevent or minimize.
Innovation Solution
A medical device and procedure that modify the flow regime within vascular access anastomoses using an external vascular support with flow-modifying components to reduce neointimal hyperplasia and luminal stenosis, thereby preventing anastomotic dysfunction by reshaping the vascular junction to promote laminar flow and reduce turbulence.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If an anastomosis is created to enable vascular access for hemodialysis, then blood flow rate is improved and dialysis is enabled, but neointimalhyperplasia develops causing luminal stenosis and anastomotic dysfunction
Solution Approach 1:
The medical device is implanted at the time of anastomosis creation to preemptively prevent neointimalhyperplasia before it can cause stenosis. The device modifies flow patterns and provides structural support during the critical early maturation period, preventing the development of harmful tissue growth that would otherwise lead to anastomotic dysfunction.
Solution Approach 2:
The medical device acts as an intermediary between the anastomotic junction and the blood flow. It modifies the flow regime by creating favorable flow patterns that reduce turbulence and stagnation, thereby preventing the hemodynamic conditions that trigger neointimalhyperplasia. The device mediates the interaction between blood flow and vessel wall to prevent pathological remodeling.
2Ease of operation
If surgical anastomosis is performed to create vascular access, then vascular access is established, but early maturation failure occurs due to juxta-anastomotic stenosis
Solution Approach 1:
The device is implanted during the initial surgical procedure to establish proper geometry before pathological changes can occur. It provides immediate structural support and flow modification to prevent the development of stenosis during the critical maturation period, ensuring proper anastomotic geometry is maintained from the outset.
Solution Approach 2:
The medical device changes the hemodynamic parameters at the anastomotic junction by modifying flow patterns, reducing turbulence, and optimizing flow distribution. These parameter changes create favorable hemodynamic conditions that prevent neointimalhyperplasia and maintain proper anastomotic geometry during maturation.
3Productivity
If conventional anastomosis technique is used, then vascular access is created, but late venous stenosis develops from neointimalhyperplasia
Solution Approach 1:
The medical device serves as an intermediary that modifies the hemodynamic environment to eliminate the triggers for neointimalhyperplasia. By creating favorable flow patterns that eliminate turbulence and stagnation zones, the device prevents the shear stress variations that initiate and propagate neointimalhyperplasia, thereby preventing late venous stenosis.
Solution Approach 2:
The device continuously maintains favorable hemodynamic parameters including flow velocity distribution, shear stress patterns, and flow laminarity. These sustained parameter changes prevent the hemodynamic triggers for neointimalhyperplasia, thereby preventing late venous stenosis while preserving dialysis function.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution effectively diminishes or eliminates areas of flow stagnation and turbulence, preventing vascular access dysfunction and promoting a stable, efficient blood flow, thereby reducing the risk of anastomotic failure and improving hemodialysis outcomes.
Implementation Method 1
The arterial portion and/or the venous portion are shaped at the vascular junction to provide a vessel rounding of the vascular junction when in apposition with the vascular junction upon implantation of the device for the vessel shaping
Implementation Method 2
modification of the flow regime within a vessel may diminish or even eliminate areas of flow stagnation or turbulence and prevent the ill-effects such occurrences may have on the vessel
Data Source
AI summary
An external vascular support for shaping a vein-artery junction between an artery and a vein anastomosed to the artery, the support comprising: an arterial portion that is shaped to be in apposition with an exterior wall of the artery when the artery is accommodated within a lumen of the arterial portion, and a venous portion that is shaped to be in apposition with an exterior wall of the vein when the vein is accommodated within a lumen of the venous portion, wherein the arterial and venous portions are physically connected at an acute angle, and the corner of the acute angle is shaped as a rounding having a radius of curvature in the range of 0.25 mm to 4 mm.