Securement Assembly for Enteral and Vesical Access Devices
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Solution Overview
Problem
Conventional securement techniques for enteral and vesical access devices are unreliable and ineffective in stabilizing these devices, leading to complications such as granulation tissue formation and leakage of gastric, intestinal, or urinary contents.
Innovation Solution
A securement assembly comprising a base with a border rim and a central portion to engage the external port of the access device, along with a pivotably coupled lid that transfers compression force to enhance retention and stabilization of the device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional securement techniques (tic-tac-toe taping) are used to stabilize access devices, then the device should remain secure, but the method is unreliable and ineffective leading to granulation tissue formation and leakage
Solution Approach 1:
The securement assembly is divided into distinct functional segments: a base portion that adheres to skin and provides structural support, a central portion that directly secures the access device, and a lid that provides protection and additional stabilization. This segmentation allows each component to address specific aspects of the securement problem, improving overall reliability while minimizing harmful effects.
Solution Approach 2:
The securement assembly acts as an intermediary device between the access device and the patient's body. It distributes mechanical forces across a larger area through the base and central portion, reducing localized stress that would otherwise cause tissue granulation. The assembly also serves as a barrier that prevents leakage of gastric, intestinal, or urinary contents around the access device.
2Ease of operation
If the access device is free to move and rotate within the stoma, then the device is easier to insert, but external forces and human-related forces cause friction and compression leading to stoma widening
Solution Approach 1:
The securement assembly is designed to be applied immediately after access device insertion, performing preliminary stabilization before external forces and movements can cause damage. The base adheres to the skin and the central portion engages the access device hub, preemptively preventing movement that would lead to friction, compression, and stoma widening.
Solution Approach 2:
The base of the securement assembly incorporates flexible adhesive materials that conform to the patient's skin and distribute forces evenly. This flexibility allows the assembly to accommodate natural skin movements while maintaining stable securesment, preventing the access device from rotating or moving excessively within the stoma.
3Stability of the object's composition
If a rigid securement structure is used to prevent movement, then device stability is improved, but the structure becomes complex and difficult to apply
Solution Approach 1:
The securement assembly combines rigid and flexible elements dynamically. The base provides rigid structural support for stability, while the adhesive layers and flexible components allow for easy application and accommodation of skin movements. The lid can be opened and closed to provide access, making the structure adaptable rather than statically complex.
Solution Approach 2:
The securement assembly merges multiple functions into a single integrated structure: the base provides adhesion and structural support, the central portion provides device engagement, and the lid provides protection and access. This consolidation simplifies the application process compared to multiple separate securement elements while maintaining comprehensive stability.
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 securement assembly effectively stabilizes enteral and vesical access devices, reducing the risk of granulation tissue formation and leakage, while also facilitating easy connection of extension tubes and preventing external forces from dislodging the device.
Implementation Method 1
an underside of the lid comprises engagement features configured to engage the side arms of the central portion to transfer a user applied compression force from the lid to the central portion
Implementation Method 2
the side arms of the central portion are resiliently flexible to facilitate selective enhanced retention of the external port of the access device
Data Source
AI summary
The present disclosure provides a securement assembly for an enteral access device or vesical access device (“access device”). The securement assembly includes a base and a lid. The base is generally configured to support an external port of the access device and the lid is pivotably coupled to the base. The base comprises a border rim and a central portion, wherein the border rim is configured to engage a skin surface of a patient around a stoma and the central portion is configured to engage the external port of the access device. The central portion may comprise opposing side arms defining an aperture through which a tube of the access device extends.