Vascular Access Declotting Catheter Bypass Stenosis

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Solution Overview

Problem

Patients undergoing hemodialysis often face challenges with vascular access due to central venous stenosis, where existing methods fail to provide reliable and long-term access, especially when peripheral venous sites are exhausted.

Innovation Solution

A vascular access device system comprising a first tubular conduit and a second tubular conduit, both potentially self-sealing, with radiopaque markers and nitinol reinforcement for resistance to kinking, coupled via connectors to establish a fluid-tight artificial blood flow path that can bypass stenosis, and a declotting catheter for clearing occlusions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If peripheral venous sites are used for vascular access, then initial access is easier to obtain, but long-term reliability deteriorates when central venous stenosis develops

Engineering Contradiction:
Improveease of accessVSAvoidlong-term access reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The vascular access system is divided into multiple segments: a peripheral venous catheter for initial access and a central venous graft for long-term reliability. The graft can be selectively deployed when stenosis develops in the peripheral site, allowing the system to transition from short-term to long-term access mode.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention transitions from two-dimensional peripheral venous access to three-dimensional central venous access by deploying a graft that extends from the peripheral vein into the right atrium, creating a new spatial pathway that bypasses stenotic segments.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Reliability

If central venous grafts are deployed to bypass stenosis, then long-term access reliability is improved, but device complexity increases

Engineering Contradiction:
Improvelong-term access reliabilityVSAvoidvascular access system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The central venous graft is designed to be nested within or alongside the peripheral venous catheter, allowing both components to coexist in a compact configuration. The graft can be collapsed within the catheter during insertion and then expanded at the target site, reducing the overall system footprint and simplifying deployment.

Inventive Principle:
Principle #7Nested doll (Nesting)

3Reliability

If self-sealing conduits are used to prevent clotting, then access reliability is improved, but the risk of clot formation and occlusion increases over time

Engineering Contradiction:
Improveaccess consistencyVSAvoidclot formation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The harmful clot is extracted from the vascular access system using a dedicated extraction catheter that can be introduced through the existing access points. The catheter includes mechanisms for capturing, fragmenting, and removing clots, allowing the self-sealing property to be maintained while periodically clearing accumulated thrombi.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

Anticoagulant therapy is applied preliminarily to prevent clot formation in the first place, and the system is designed with clot-resistant surface treatments. Regular flushing protocols are implemented to prevent stasis-induced clotting before clots can form and cause occlusion.

Inventive Principle:
Principle #10Preliminary action

4Adaptability or versatility

If multiple conduits and connectors are used to create artificial blood flow paths, then bypass capability is improved, but fluid-tight connection reliability deteriorates

Engineering Contradiction:
Improvebypass capabilityVSAvoidfluid-tight connection
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The peripheral venous catheter and central venous graft are merged into a single integrated access system, eliminating the need for separate connections. The graft is directly anastomosed to the catheter tip, creating a continuous fluid pathway without external connectors that could leak or disconnect.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentEP3592401B1Vascular access assembly declotting systems and methods
Publication Date: 2024.09.18 MERIT MEDICAL SYSTEMS INC
  • EP3592401B1 patent drawingFigure 1
  • EP3592401B1 patent drawingFigure 2A
  • EP3592401B1 patent drawingFigure 2B

AI summary

Methods of declotting vascular access technologies, such as vascular access assemblies that facilitate hemodialysis, are provided. The methods can include disposing a catheter within a patient to access a vascular access assembly within the heart of the patient. The catheter can be coupled to the vascular access assembly such that a clot can be evacuated from within the vascular access assembly via the catheter.