Self-Healing Casing Catheter Securement Device

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Solution Overview

Problem

Conventional catheter securement units fail to properly stabilize catheter assemblies, leading to undesirable movement, complications such as dislodgment, phlebitis, extravasation, occlusion, leakage, and bloodstream infections, and do not provide adequate infection protection at the injection site.

Innovation Solution

A securement device with a self-healing casing that securely attaches to the skin, encloses the catheter assembly, and forms a seal around the lumens, using a base with a stretchable adhesive and pull tabs for easy removal, eliminating the need for additional tapes or sutures, and incorporating anti-microbial gel for infection prevention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional catheter securement units (tapes, patches, sutures) are used to secure the catheter assembly, then the catheter assembly can be attached to the skin, but the catheter assembly experiences undesirable movement and lacks proper stabilization

Engineering Contradiction:
Improvecatheter assembly stabilizationVSAvoidcatheter assembly movement control
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The securement device is divided into distinct functional components: a base for skin attachment, a casing for catheter enclosure, and a seal for luminal closure. This segmentation allows each component to perform its specific function optimally, providing reliable stabilization while maintaining ease of operation through modular design.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The catheter assembly is nested within the casing, which is mounted on the base. The seal is nested within the casing to enclose the lumens. This nested structure provides multiple levels of securement, ensuring the catheter assembly is firmly stabilized while allowing for easy operation through a compact, integrated design.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Reliability

If conventional catheter securement units are used, then the catheter assembly can be secured to the skin, but complications such as dislodgment, phlebitis, extravasation, occlusion, leakage, and bloodstream infections occur

Engineering Contradiction:
Improvecatheter assembly securityVSAvoidinjection site infections and complications
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The seal acts as an intermediary barrier between the catheter lumens and the external environment, preventing bacterial contamination and fluid leakage. The casing serves as another intermediary layer that encloses the catheter assembly, providing protection against phlebitis and extravasation. These intermediary structures eliminate direct contact between potential contaminants and the injection site, reducing the risk of infections and complications.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The casing and seal are constructed as flexible barriers that conform to the catheter assembly and skin surface. This flexibility ensures proper sealing and enclosure while allowing for easy application and removal. The thin film structure provides effective protection against infections and complications without causing discomfort or interfering with catheter function.

Inventive Principle:
Principle #30Flexible shells and thin films

3Area of stationary object

If conventional catheter securement units are used, then the catheter assembly can be attached, but they do not provide proper coverage of the injection site, resulting in infection

Engineering Contradiction:
Improveinjection site coverageVSAvoidinjection site infection
Core Design Contradiction:
Area of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The base provides universal skin attachment and injection site coverage simultaneously. The casing encloses the catheter assembly while also providing additional protective coverage over the injection site. This multi-functionality ensures comprehensive protection against infection while maintaining ease of operation through a single integrated device that performs multiple protective functions.

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Reliability

If sutures are used to secure the catheter assembly, then the catheter assembly can be firmly attached to the skin, but suture related infections and complications arise

Engineering Contradiction:
Improvecatheter assembly attachment strengthVSAvoidsuture related infections
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The mechanical suture system is replaced with an adhesive base and enclosed casing system. The base uses adhesive bonding to attach to the skin, eliminating the need for sutures that penetrate the skin and create infection risks. The casing provides mechanical enclosure and stabilization without requiring invasive attachment methods. This substitution maintains reliable attachment strength while eliminating suture-related infections and complications.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 device firmly secures the catheter assembly, prevents movement and infections, and allows for easy removal without causing discomfort, thereby reducing complications and maintaining a sterile injection site.

Implementation Method 1

The casing includes a material having a self-healing property. The casing at least partially ruptures to receive at least one lumen of the catheter assembly therethrough. Moreover, upon receiving the at least one lumen of the catheter assembly therethrough, the casing forms a seal around the at least one lumen.

Methodology Applied
Scientific EffectSelf-healing property:

Implementation Method 2

a base having a first major surface and an opposing second major surface... configured to be detachably secured to a skin of a user

Methodology Applied
Scientific EffectAdhesive: Adhesive

Data Source

PatentUS20240390649A1Securement device, kit, and method of using securement device
Publication Date: 2024.11.28 SOLVENTUM INTELLECTUAL PROPERTIES CO
  • US20240390649A1 patent drawing
  • US20240390649A1 patent drawing
  • US20240390649A1 patent drawing

AI summary

A securement device (100) for a catheter assembly (10) includes a base (102) having a first major surface (104) and an opposing second major surface (106). The base (102) defines a through cavity (108). The base (102) is detachably secured to a skin (12) of a user, such that an injection site (22) associated with the catheter assembly is disposed within the through cavity (108). The through cavity (108) receives at least a portion of the catheter assembly (10) therein. The securement device (100) also includes a casing (116) that encloses the through cavity (108) and the catheter assembly (100). The casing (116) engages with the catheter assembly (100) to secure the catheter assembly (100) within the through cavity (108). The casing (116) includes a material having a self-healing property. The casing (116) at least partially ruptures to receive at least one lumen (18) of the catheter assembly (100) therethrough. Moreover, upon receiving the at least one lumen (18) of the catheter assembly (100) therethrough, the casing (116) forms a seal (140) around the at least one lumen (18).