Microneedle Stabilisation System for Medical Devices
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Solution Overview
Problem
Existing medical device stabilization systems, such as those for catheters, often require cumbersome and uncomfortable methods like straps or adhesives, which can cause tissue discomfort and are inefficient, as they may degrade over time and fail to securely anchor devices against tension or displacement.
Innovation Solution
A stabilisation system comprising a body with displaceable sections and microneedles that penetrate the tissue to create a secure anchor, using a closure member to lock the device in place, providing a robust and comfortable solution for securing medical devices without the need for straps or adhesives.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If straps or adhesives are used to secure medical devices to tissue, then the device can be anchored to the skin, but the application becomes difficult and time consuming, and the straps can cause tissue discomfort and chaffing
Solution Approach 1:
The device is divided into a base portion with multiple protrusions (microneedles) that can be independently inserted into the tissue, and a closure member that secures the catheter. This segmentation allows for easier application compared to traditional straps while maintaining reliable anchoring through multiple insertion points.
Solution Approach 2:
The invention replaces the mechanical strap system with a microneedle insertion mechanism. Instead of using external straps that wrap around and tension the tissue, the system uses microneedles that penetrate and anchor directly into the tissue, providing secure fixation without the need for external tensioning elements.
2Reliability
If straps are tensioned to adequately secure the device, then anchoring strength is improved, but undue pressure is put on surrounding tissue causing discomfort and chaffing
Solution Approach 1:
The invention replaces the strap tensioning mechanism with microneedle penetration. The microneedles provide anchoring strength through their insertion into the tissue rather than through external tension, eliminating the need for straps that would otherwise apply pressure and cause tissue discomfort or chaffing.
Solution Approach 2:
The anchoring force is concentrated at specific local points where the microneedles penetrate the tissue, rather than being distributed across a broad area as with straps. This localized anchoring provides sufficient holding strength without applying undue pressure to surrounding tissue areas.
3Reliability
If adhesives are used to secure the device, then anchoring is achieved, but the efficacy varies significantly depending on skin condition and adhesives degrade over time
Solution Approach 1:
The invention replaces the chemical adhesive bonding mechanism with a mechanical microneedle penetration system. The microneedles provide physical anchoring through insertion into the tissue, which does not depend on skin condition or degrade over time like adhesives may.
Solution Approach 2:
The microneedle stabilisation device appears to be designed as a disposable single-use item, with the microneedles providing reliable anchoring for the duration of the medical procedure or monitoring period, after which the entire device can be removed and discarded, avoiding the degradation issues associated with reusable adhesive systems.
4Reliability
If multiple protrusions are used to anchor the device, then anchoring strength is improved, but the device complexity increases
Solution Approach 1:
The base portion serves multiple functions: it houses the array of microneedles for tissue penetration, provides structural support for the catheter, and integrates the closure member mechanism. This multi-functionality reduces overall device complexity despite the presence of multiple protrusions.
Solution Approach 2:
The invention merges the anchoring function (microneedles), the catheter retention function (closure member), and the structural support function into a single integrated device. This consolidation achieves strong anchoring through multiple protrusions while maintaining relatively simple overall device architecture.
Data Source
AI summary
A stabilisation system for securing a medical device such as a catheter to tissue, in particular skin, the stabilisation system comprising a main body having a first section and a second section displaceable relative to one another to translate the system between an undeployed state and a deployed state, each section including an array of microneedles extending from a tissue contacting surface of the body and which penetrate the skin in response to the above displacement, the stabilisation system further comprising a closure member displaceable between an open position exposing a retention zone on the body and a closed position at least partially occluding the retention zone, within which retention zone the catheter or other medical device may be captured.