Expandable Fistula Catheter for Fibrotic Tissue Scoring
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Solution Overview
Problem
Conventional stenosis devices are not well suited for treating fibrotic tissue in AV fistulas, which often leads to stenosis and failure of the fistula.
Innovation Solution
An intravascular device with an expandable portion comprising struts and a sliding inner sleeve, equipped with tissue modification elements such as sharpened edges for scoring fibrotic tissue, and irrigation/suction elements for removing thrombi and particulate, connected to a handle assembly for controlled operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional stenosis devices are used to treat AV fistulas, then the devices can be easily operated, but they are not effective for treating fibrotic tissue in AV fistulas
Solution Approach 1:
The device incorporates specialized tissue modification elements with specific geometric configurations (e.g., wedge-shaped elements with angled cutting surfaces) that are locally adapted to score and modify fibrotic tissue in AV fistulas, rather than using a uniform design throughout the device
Solution Approach 2:
The treatable surface of the device is divided into multiple discrete tissue modification elements arranged in arrays, allowing different zones to address different aspects of fibrotic tissue treatment simultaneously
2Manufacturing precision
If tissue modification elements with sharpened edges are used to score fibrotic tissue, then luminal gain is achieved, but the device complexity increases
Solution Approach 1:
The tissue modification elements are integrated into a flexible expandable framework that can be collapsed into a compact configuration for delivery through catheters, then expanded at the treatment site to deploy the scoring elements against the vessel wall
Solution Approach 2:
The expandable struts and tissue modification elements are nested within a delivery catheter in a collapsed state, allowing the complex device to be delivered through a minimally invasive approach, then deployed in situ
3Object-generated harmful factors
If irrigation and suction elements are added to remove thrombi and particulate, then treatment completeness is improved, but the device complexity increases
Solution Approach 1:
The device merges multiple treatment functions (tissue scoring, thrombus removal, and particulate evacuation) into a single integrated platform, combining tissue modification elements with irrigation and suction channels within the same expandable structure
Solution Approach 2:
The expandable device framework serves multiple functions simultaneously: providing structural support for tissue scoring, housing irrigation channels for thrombus removal, and creating suction pathways for particulate evacuation, making it a multi-functional treatment device
Data Source
AI summary
An intravascular device for treating a fistula and methods of using the same are provided. A catheter tube extends from a handle assembly and is attached to an expandable portion which is selectively movable between a first position and an expanded position. Incising elements located at the expandable portion have tapered profiles for creating incisions in tissue accumulated at the fistula upon axial retraction through the fistula. Irrigation or suction devices may be provided.