Self-Sealing Vascular Access Device for Hemodialysis

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Solution Overview

Problem

Current AV grafts and fistulas used for hemodialysis are prone to degradation due to repeated needle sticks and intimal hyperplasia, leading to shorter lifespans and increased risk of infection and thrombus formation, necessitating frequent interventions and vascular access maintenance.

Innovation Solution

Development of self-sealing access devices with elastomeric and bioabsorbable materials and embedded elastic support elements that can accommodate needle insertion and resiliently return to seal the opening, reducing the risk of degradation and infection by providing a self-closing mechanism.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If repeated needle sticks are performed through AV grafts and fistulas for hemodialysis access, then dialysis treatment can be delivered, but the vascular access site degrades leading to shorter lifespan and increased infection risk

Engineering Contradiction:
Improvedialysis treatment frequencyVSAvoidvascular access durability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The device segments the vascular access site into multiple puncture points distributed across the device surface, allowing needle access through multiple locations rather than repeated punctures at a single site, thereby distributing mechanical stress and reducing degradation at any one location

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The self-sealing membrane is pre-installed at the vascular access site before dialysis treatments begin, creating a protective barrier that anticipates and prevents degradation from future needle sticks, rather than addressing damage after it occurs

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If AV grafts are used instead of fistulas for easier implantation and faster readiness, then ease of operation is improved, but the graft lifespan is shorter and infection risk increases

Engineering Contradiction:
Improveimplantation easeVSAvoidgraft lifespan
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The self-sealing membrane automatically seals puncture sites after needle removal without requiring surgical intervention or complex closure mechanisms, allowing the graft to maintain integrity and resist infection independently, thereby extending its functional lifespan while keeping the device simple to implant

Inventive Principle:
Principle #25Self-service

3Quantity of substance

If larger gauge needles (14-16 Gauge) are used for dialysis access, then adequate blood flow is achieved, but the mechanical trauma to the vessel increases degradation

Engineering Contradiction:
Improveblood flow volumeVSAvoidmechanical trauma
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The self-sealing membrane provides a cushioning protective layer between the large-bore needle and the underlying vascular structure, absorbing and distributing the mechanical trauma from needle insertion while still permitting adequate blood flow through the larger gauge needle

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

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 self-sealing access devices enhance the durability and longevity of vascular access sites by reducing the risk of infection and thrombus formation, allowing for repeated access while minimizing the risk of graft or vessel degradation, thereby improving patient outcomes and reducing the need for frequent interventions.

Implementation Method 1

a plurality of elastic support elements surrounding or embedded in the base material. The support elements may be separable to accommodate creating an opening through the base material for receiving one or more instruments through the base material, and biased to return towards a relaxed state for self-closing the opening after removing the one or more instruments

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP2983625B1Self-closing devices and apparatus and methods for making and delivering them
Publication Date: 2024.02.14 SOLINAS MEDICAL INC
  • EP2983625B1 patent drawingFigure 1A~2C
  • EP2983625B1 patent drawingFigure 3~4C
  • EP2983625B1 patent drawingFigure 5A~6C

AI summary

A self-closing device for implantation within a patient's body includes base material including an inner surface area for securing the base material to a tissue structure, and a plurality of support elements surrounding or embedded in the base material. The support elements are separable to accommodate creating an opening through the base material for receiving one or more instruments through the base material, and biased to return towards a relaxed state for self-closing the opening after removing the one or more instruments. The device may be provided as a patch, cuff, or integrally attached to a tubular graft or in various shapes.