PICC Line Securement Sleeve with Adjustable Flap

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Solution Overview

Problem

Current solutions for securing peripherally inserted central catheters (PICC) lines in patients' arms are inadequate, as they lack adjustability, breathability, and effective prevention of catheter migration and skin irritation, and are aesthetically unappealing.

Innovation Solution

A securement sleeve with a first upper portion featuring exit ports and breathable openings, and a second lower portion with a securement flap or strap for adjustable fitting, made from materials like cotton or neoprene, to securely cover and protect the PICC line, preventing accidental removal and irritation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a single-layer sock or stockinette is used to cover the catheter, then the device is simple to manufacture, but it fails to adequately secure the catheter line and prevent migration

Engineering Contradiction:
Improvecatheter secement effectivenessVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The securement device is divided into multiple functional layers: an inner layer with adhesive properties for direct catheter attachment, a middle layer for cushioning and moisture management, and an outer layer for structural support and aesthetics. This segmentation allows each layer to perform its specific function optimally, thereby securing the catheter effectively while maintaining reasonable manufacturing complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device utilizes composite material construction combining different fabrics and adhesive materials in a single integrated structure. The inner layer uses adhesive material for securement, the middle layer uses breathable fabric for comfort, and the outer layer uses aesthetic fabric for appearance. This composite approach achieves reliable catheter secement without excessive complexity.

Inventive Principle:
Principle #40Composite materials

2Reliability

If thick fabric is used to make the protective sleeve, then the catheter is well protected, but breathability around the insertion site is prevented

Engineering Contradiction:
Improvecatheter protectionVSAvoidbreathability obstruction
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device applies different fabric properties to different regions: the area surrounding the catheter insertion site uses breathable, moisture-wicking material to prevent skin irritation, while other portions of the sleeve use thicker protective material for catheter security. This local differentiation resolves the contradiction between protection and breathability.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The sleeve is segmented into a catheter-coverage zone with thicker protective material and a skin-exposure zone with breathable material. This segmentation allows the device to provide adequate catheter protection while maintaining breathability around the insertion site to prevent skin issues.

Inventive Principle:
Principle #1Segmentation

3Reliability

If a fixed-size protective device is used, then manufacturing is simplified, but the device cannot provide a customized secure fit for different patients

Engineering Contradiction:
Improvefit securityVSAvoiddevice production
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The device incorporates elastic materials and stretchable fabrics that allow it to dynamically adapt to different arm circumferences and patient sizes. This dynamic property enables a single fixed-size device to provide a customized secure fit for various patients without complicating the manufacturing process.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The device uses materials with variable physical properties, particularly elastic modulus and stretch characteristics, that allow it to conform to different patient anatomies. This parameter flexibility enables one fixed-size device to effectively fit multiple patients while maintaining secure attachment.

Inventive Principle:
Principle #35Parameter changes

4Reliability

If the catheter line exits through the top of the protective sock, then the device structure is simple, but the catheter remains vulnerable to snagging and pulling

Engineering Contradiction:
Improvecatheter protection from snaggingVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The catheter is nested within a reinforced channel or tunnel structure embedded in the device. This internal channel protects the catheter from external snagging forces while allowing it to exit at the appropriate location. The nested structure provides protection without significantly increasing overall device complexity.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

Instead of allowing the catheter to exit through the top surface, the device routes the catheter through a protected three-dimensional path within the device structure. This dimensional change from surface exit to internal channel exit protects the catheter from snagging while maintaining reasonable structural complexity.

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

Data Source

PatentUS12115321B2Protective securement device
Publication Date: 2024.10.15 MIGHTY WELL INC
  • US12115321B2 patent drawing
  • US12115321B2 patent drawing

AI summary

The present disclosure is directed to a device that can be in the form of a sleeve that has a first upper portion and a second lower portion. The first upper portion can include exit ports to allow various catheters, such as peripherally inserted central catheter (PICC) lines, to extend through openings therein. The second lower portion is inverted upwardly over the first portion and can have a securement flap on an outer surface to tighten around the patient's arm and around the PICC line to ensure that the PICC line and the sleeve remain stationary relative to the patient's arm.