Sterile Scab Separation Device for Vascular Access

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Solution Overview

Problem

Existing devices for accessing a patient's vascular system through a site with a pre-existing scab are not sterile, risking contamination and damage to the vascular tissue, as they often require non-sterile tools for scab removal and are prone to physical damage during handling.

Innovation Solution

A scab separation device with a terminal point and lifting surface for initial separation and removal of the scab, integrated with a sterility-maintaining cover and grip portion, allowing for sterile operation and minimizing contamination risk, is designed to assist in accessing the vascular site without compromising sterility or causing tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a non-sterile device or second use of a sterile device is used for scab removal, then scab removal can be performed, but bacteria are injected into the patient's bloodstream causing contamination risk

Engineering Contradiction:
Improvescab removal capabilityVSAvoidbacterial contamination
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The device is divided into distinct functional segments: a sterile needle component for vascular access and a separate scab removal component. The scab removal component can be discarded after use, while the sterile needle remains intact for its intended purpose. This segmentation allows the scab removal function to be performed without compromising the sterility of the vascular access pathway.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The scab removal component is designed as a disposable element that can be discarded after single use. This eliminates the need to reuse sterile devices for scab removal, thereby preventing bacterial contamination while maintaining the sterility of the vascular access site for subsequent needle insertion.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Object-affected harmful factors

If a sterile needle tip is used for scab removal, then sterility is maintained, but the needle becomes dulled or deformed making insertion more painful or damaging

Engineering Contradiction:
Improvesterility maintenanceVSAvoidneedle insertion ease
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The device separates the scab removal function from the vascular access function into distinct components. The sterile needle tip remains dedicated to vascular access and is not used for scab removal, preventing dulling or deformation. The scab removal is performed by a separate disposable component that does not interfere with the integrity of the sterile needle.

Inventive Principle:
Principle #1Segmentation

3Object-affected harmful factors

If the access site is cleaned and prepped, then sterility is improved, but the scab remains intact blocking access to the vascular site

Engineering Contradiction:
Improvesterility levelVSAvoidvascular access capability
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The device enables preliminary cleaning and preparation of the access site while the scab remains intact. The sterile needle can be inserted through the cleaned area, and the scab removal component is then used to remove the scab blocking the vascular access. This sequence allows sterility to be established before attempting vascular access.

Inventive Principle:
Principle #10Preliminary action

4Object-affected harmful factors

If the scab is removed by picking at the edge with sterile tweezers, then sterility is maintained, but particulate matter is carried into the bloodstream

Engineering Contradiction:
Improvesterility maintenanceVSAvoidparticulate contamination
Core Design Contradiction:
Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

The scab removal component is designed to extract and remove the scab as a complete unit from the vascular access site. By removing the scab intact rather than picking at it with tweezers, the device prevents particulate matter from being generated and carried into the bloodstream while maintaining sterility through the use of a sterile, disposable component.

Inventive Principle:
Principle #2Taking out (Extraction)

Data Source

PatentUS8506536B2Medical devices and methods for assisting in sub-scab access
Publication Date: 2013.08.13 NXSTAGE MEDICAL INC
  • US8506536B2 patent drawing
  • US8506536B2 patent drawing
  • US8506536B2 patent drawing

AI summary

Device and methods for separating a scab from a vascular access site are disclosed. The devices include providing a scab separation device having a point for initial separation of a portion of a scab from a patient's flesh, and a series of inclined surfaces leading from the point to lift and separate the scab from the access site. The scab separation device is provided with a cover so that the device is maintained as sterile. In a preferred embodiment, the scab separation device is provided as a set or assembly with a needle or needle set and, in a more preferred embodiment, the scab separation device cover is also used as a cover for a needle to maintain sterility both of an operative end of the separation device and of the needle.