Skin-Mounted Lumen Securement Structure for Stable Catheter Fixation

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Solution Overview

Problem

Conventional securement means for medical devices, such as tapes and sutures, fail to properly secure medical devices to the skin, leading to complications like dislodgment, infection, and discomfort, and do not provide adequate coverage of injection sites.

Innovation Solution

A securement device with a main body and insert, where the main body is deformable between open and closed configurations, and the insert is deformable between release and secure states, allowing secure attachment and easy removal of medical device lumens without causing discomfort.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional securement means (tapes, patches, sutures) are used to secure medical devices to skin, then the medical devices can be attached to the skin, but the securement is insufficient leading to dislodgment, movement, and complications

Engineering Contradiction:

Improvesecurement reliabilityVSAvoidsecurement stability

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The securement device is divided into multiple functional segments: a base portion for skin attachment, a body portion for lumen reception, and an insert with groove for securement. This segmentation allows each component to perform its specific function optimally, with the base providing broad skin contact and the insert providing precise lumen engagement through the groove structure.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The insert is nested within the body portion, and the lumen is received within the groove of the insert. This nested structure allows the smaller components to be contained within larger ones, creating a compact and integrated securement system where the insert with the groove is positioned inside the body portion to engage the lumen.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Object-affected harmful factors

If conventional securement means are used, then attachment is achieved, but injection sites are not properly covered leading to infection risk

Engineering Contradiction:

Improveinfection riskVSAvoidcoverage area

Core Design Contradiction:

Object-affected harmful factorsVSArea of stationary object

Solution Approach 1:

The securement device serves multiple functions: it secures the lumen to the skin, covers the injection site to prevent infection, and provides a structured interface for medical device attachment. The base portion with adhesive layer provides broad coverage for infection prevention, while the body portion and insert provide securement functionality.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Ease of operation

If conventional securement means are used, then medical devices are attached, but removal is difficult and causes discomfort

Engineering Contradiction:

Improveremoval easeVSAvoidpatient discomfort

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The securement device is designed as a disposable component that can be easily applied and removed without causing discomfort. The adhesive layer on the base portion allows for clean detachment, and the structured body and insert design facilitates easy removal of the entire device as a unit, preventing tissue damage and patient discomfort.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

4Object-affected harmful factors

If conventional securement means are used, then attachment is achieved, but fluid pressure causes discomfort

Engineering Contradiction:

Improvefluid pressure discomfortVSAvoidsecurement strength

Core Design Contradiction:

Object-affected harmful factorsVSStrength

Solution Approach 1:

The insert is formed from a flexible material that can deform to accommodate fluid pressure changes while maintaining securement. The groove structure in the flexible insert allows it to conform to the lumen and adapt to pressure variations, preventing discomfort while maintaining adequate securement strength through the flexible engagement.

Inventive Principle:

Principle #30Flexible shells and thin films

Data Source

PatentEP4482555B1Securement device, kit comprising securement device, and method of securing securement device on skin of user

Publication Date: 2026.01.21 SOLVENTUM INTELLECTUAL PROPERTIES CO

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AI summary

A securement device (100) for securing a lumen (12) of a medical device (14) includes a main body (110) configured to be detachably secured to a skin of a user. The main body includes a first body portion (112) including a first cavity surface (118) and a second body portion (142) including a second cavity surface (148) pivotally coupled to the first cavity surface. The first and second cavity surfaces together define a cavity (170). The securement device further includes an insert (180) fixedly coupled to the main body and at least partially received within the cavity. The insert includes a groove (184) configured to receive the lumen of the medical device. The main body is deformable between an open configuration and a closed configuration, and the insert is correspondingly deformable between a release state and a secure state. In the release state, the groove is configured to receive the lumen therein. In the secure state, the lumen is secured within the groove.