Catheter Interface Shield for Umbilical CLABSI Prevention

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Solution Overview

Problem

Current technologies lack a device specifically designed for protecting the umbilical stump and stabilizing umbilical catheters in neonates, leading to a high incidence of central line-associated bloodstream infections (CLABSIs) in premature infants.

Innovation Solution

A shield device with a wall defining a cavity for the umbilical stump and an opening for the catheter, featuring clips and seals to secure and stabilize the catheter, along with adhesive for attachment to the patient, designed to prevent bacterial migration and maintain catheter stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If umbilical catheters are placed in premature infants to provide necessary medical access, then reliable venous system access is achieved, but the risk of central line-associated bloodstream infections (CLABSIs) increases significantly

Engineering Contradiction:

Improvevenous system accessVSAvoidCLABSI risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A protective device is introduced as an intermediary between the umbilical catheter and the external environment. This device includes a barrier film that seals around the catheter insertion site, creating a physical mediator that blocks bacterial migration while allowing the catheter to function. The barrier film acts as a protective interface that maintains catheter access while preventing infection.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The protective device utilizes a flexible barrier film that can conform to the umbilical insertion site and seal around the catheter. This thin film structure provides infection protection while maintaining flexibility to accommodate the catheter's position and movement, preventing bacterial entry without compromising venous access.

Inventive Principle:

Principle #30Flexible shells and thin films

2Ease of operation

If standard catheterization procedures are used without specialized protective devices, then the procedure remains simple, but the umbilical stump is exposed to environmental bacteria increasing infection risk

Engineering Contradiction:

Improvecatheterization procedureVSAvoidbacterial exposure

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The protective device serves as an intermediary barrier between the umbilical stump and environmental bacteria. It includes components such as a barrier film and sealing mechanisms that create a protected environment around the catheter insertion site, reducing bacterial exposure while maintaining procedural simplicity through straightforward application.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The protective device is designed as a disposable component that can be easily applied and removed. This single-use approach ensures infection protection without requiring complex sterilization or maintenance procedures, keeping the overall process simple while effectively preventing bacterial contamination during the critical period of catheter use.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Stability of the object's composition

If the umbilical catheter is secured with traditional methods, then catheter placement is achieved, but catheter stability and prevention of bacterial migration are insufficient

Engineering Contradiction:

Improvecatheter placementVSAvoidbacterial migration

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

A sealing mechanism acts as an intermediary between the catheter and the umbilical stump, creating a barrier that prevents bacterial migration along the catheter interface. This seal ensures catheter stability while blocking the primary pathway for bacterial entry, addressing both fixation and infection prevention needs.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

A flexible barrier film is used to seal around the catheter at the umbilical insertion site. This thin film structure provides a stable seal that prevents bacterial migration while accommodating the catheter's position, enhancing both catheter stability and infection protection without compromising placement.

Inventive Principle:

Principle #30Flexible shells and thin films

Data Source

PatentUS20250242132A1Systems and methods for securing catheters

Publication Date: 2025.07.31 NOVONATE INC

AI summary

A catheter interface protection device can include a shield. The shield can include an open bottom, a transparent upper surface, sidewalls, and a cavity at least partially defined by the bottom, the upper surface, and the sidewalls. The device can include a vent. The device can include a clip, a tether, and a latch. A non-therapeutic method of protecting a catheter interface can include extending a catheter in the subject through a slot in a catheter interface protection device, wrapping the catheter at least partially around a clip of the catheter interface protection device, and securing a latch of the catheter interface protection device around the clip. A device for positioning a subject in a prone position can include a padded area including an opening configured to accommodate a catheter interface protection device.