Anastomotic Connector with Anchoring Flanges for Immediate Vascular Access

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Solution Overview

Problem

Current vascular access methods for hemodialysis, such as temporary catheters, are associated with increased risk of bleeding, infection, and higher mortality rates due to the lengthy maturation period of arteriovenous fistulas, and are not feasible for all patients.

Innovation Solution

A percutaneous vascular access device with a stented tubular main body and flanges that anchors to the vessel wall, allowing immediate cannulation and maturation of outflow veins for subsequent conversion to a fistula, eliminating the need for temporary catheters.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of time

If a temporary catheter is used for vascular access, then immediate access is available for hemodialysis, but the patient is exposed to additional risk of bleeding and infection and has higher mortality rate

Engineering Contradiction:
Improvematuration period of fistulaVSAvoidrisk of bleeding and infection
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The percutaneous anastomotic connector is implanted before the fistula has a chance to mature, performing the vascular connection action in advance. This allows immediate dialysis access while the vein gradually matures underneath the connector, eliminating the need for temporary catheters and their associated risks

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The percutaneous anastomotic connector serves as an intermediary device between the artery and vein, providing immediate vascular access for dialysis while allowing the vein to mature underneath. This mediator device eliminates the need for temporary catheters and enables transition to permanent fistula access

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If a direct anastomosis is performed, then permanent vascular access is achieved, but it takes up to twelve weeks for the fistula to mature and provide adequate blood flow

Engineering Contradiction:
Improveadequate blood flowVSAvoidmaturation period of twelve weeks
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The percutaneous anastomotic connector is implanted immediately to provide instant vascular access for dialysis, performing the connection action before the natural maturation period begins. This allows blood flow needs to be met immediately while the vein matures underneath the connector over time

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The device transitions dynamically from a percutaneous configuration providing immediate access to a subcutaneous configuration where the vein matures underneath. The connector allows the vein to gradually expand and mature while maintaining patent access, adapting the vascular access from acute to chronic state

Inventive Principle:
Principle #15Dynamics

3Ease of operation

If a temporary catheter is used, then access is provided during the maturation period, but the patient experiences discomfort and additional medical risks

Engineering Contradiction:
Improveaccess for hemodialysisVSAvoiddiscomfort and risk of bleeding and infection
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The percutaneous anastomotic connector acts as an intermediary device that provides vascular access during the maturation period without requiring temporary catheters. This mediator structure eliminates the harmful factors of catheter-related discomfort, bleeding risks, and infections while maintaining dialysis access

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The percutaneous anastomotic connector is designed as a temporary device that is replaced once the vein matures, eliminating the need for prolonged catheter use. This short-living implanted device provides access during the critical maturation period and is then removed, avoiding long-term catheter complications

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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

Enables immediate and secure vascular access for hemodialysis without the risks associated with temporary catheters, facilitating the maturation of veins for fistula conversion and reducing mortality rates.

Implementation Method 1

The flanges are configured to anchor the anchor device against the inner wall of a fluid passageway

Methodology Applied
Scientific EffectMechanical engagement: Mechanical Fastener

Implementation Method 2

Generally tubular main body comprises a stented portion

Methodology Applied
Scientific EffectStent structural support:

Data Source

PatentUS10456239B2Anastomotic connector and system for delivery
Publication Date: 2019.10.29 PHRAXIS
  • US10456239B2 patent drawing
  • US10456239B2 patent drawing
  • US10456239B2 patent drawing

AI summary

An anastomotic connector comprises a vessel anchor, a midgraft connector and graft material. The vessel anchor has a generally tubular main body including a distal end and a proximal end, the distal end defining a plurality of flanges integrally formed with the tubular main body and being movable from a first loaded position to a second expanded position. The midgraft connector operably couples the graft to the vessel anchor to form an anastomotic connector between an artery and a vein.