Vascular Access Gateway Element
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Solution Overview
Problem
End-stage renal disease patients face frequent hospital visits and complications due to thrombosis, infection, and stenosis associated with current dialysis access methods, which lack durability and long-term efficacy.
Innovation Solution
A luminal access system featuring a port and subcutaneous element with shape memory materials, allowing for percutaneous or surgical placement, and incorporating one-way valves and expandable gateway elements to provide durable, low-profile vascular access for dialysis, reducing thrombosis and infection risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional dialysis access methods (tunneled catheters, arteriovenous fistulas, or grafts) are used, then immediate vascular access is achieved, but the systems suffer from frequent thrombosis, infection, stenosis, and require repeat hospital visits for maintenance
Solution Approach 1:
The system divides the access device into separate functional segments: a portal positioned outside the body lumen and a gateway element positioned inside the body lumen. This segmentation allows the portal to remain external (reducing infection risk) while the gateway element provides the intraluminal access function, with each segment optimized for its specific role and independently manageable.
Solution Approach 2:
The invention extracts the portal component from the intraluminal environment and positions it outside the body lumen, connected via a conduit. This extraction removes the portal (a potential infection source) from the sterile intraluminal environment while maintaining functional connectivity, thereby reducing infection risk without compromising access capability.
2Productivity
If larger diameter catheters are used to ensure adequate blood flow for dialysis, then sufficient dialysis clearance is achieved, but the catheters cause more fibrosis, scarring, and stenosis of the lumens
Solution Approach 1:
The gateway element is designed to be dynamically expandable between a first configuration (when not in use) and a second configuration (when providing access). This dynamic capability allows the system to provide large lumen diameter during dialysis procedures for adequate blood flow, while minimizing the footprint during non-use periods to reduce fibrosis and stenosis of the body lumen.
Solution Approach 2:
The gateway element operates periodically, expanding to a larger diameter configuration during dialysis treatment sessions to ensure adequate blood flow and clearance efficiency, then contracting to a smaller configuration between sessions to minimize tissue irritation, fibrosis, and stenosis. This periodic expansion and contraction aligns the device's physical presence with its functional requirements.
3Ease of operation
If traditional vascular access systems are used, then immediate access is provided, but the systems require frequent maintenance, repair, and hospital visits
Solution Approach 1:
The system incorporates a reservoir or storage capacity within the portal or conduit system that can be pre-filled or pre-prepared with necessary components or medications. This beforehand cushioning allows for extended periods between maintenance visits and provides a buffer against access failures, reducing the frequency of urgent hospital visits while maintaining operational availability.
4Adaptability or versatility
If tunneled catheters are placed first followed by arteriovenous fistula creation, then vascular access is established, but the process involves multiple procedures and extended treatment timelines
Solution Approach 1:
The portal-gateway system serves multiple functions: it provides immediate vascular access like a catheter, can be expanded to provide high-flow access similar to a fistula, and allows for various delivery methods (percutaneous or surgical). This multi-functionality consolidates what were previously separate sequential procedures into a single integrated device, reducing the overall treatment timeline while maintaining access flexibility.
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 system reduces the need for frequent hospital visits, minimizes thrombosis and infection risks, and offers a more durable solution for long-term dialysis access, improving patient outcomes and healthcare cost containment.
Implementation Method 1
subcutaneous element may comprise single channel/lumen or multiple channels/lumens; subcutaneous element may comprise shape memory material
Implementation Method 2
at least one one-way valve proximate the distal end of the conduit and within the fluid pathway of the sidewall of the conduit
Implementation Method 3
a gateway element comprising a through lumen operably connected to an outer diameter of the conduit, the gateway element comprising a first radially compressed configuration in which the gateway element causes occlusion within the through lumen, and a second radially expanded configuration in which the gateway element permits passage of fluids within the through lumen
Data Source
AI summary
A vascular access system can include a port configured to be implanted outside of a target body lumen, at least one conduit fluidly connected to the port, and at least one one-way valve proximate the distal end of the conduit and within the fluid pathway of the sidewall of the conduit. The system can also include a gateway element comprising a through lumen operably connected to an outer diameter of the conduit, the gateway element comprising a first radially compressed configuration in which the gateway element causes occlusion within the through lumen, and a second radially expanded configuration in which the gateway element permits passage of fluids within the through lumen.