Self-detachable medical device with dissolving layer
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Solution Overview
Problem
Current medical devices implanted with therapeutic agents often have limited payload capacity and inability to provide sustained release without compromising device integrity, and existing solutions do not effectively manage adhesion or prolonged release of agents.
Innovation Solution
Self-detachable medical devices featuring an implantable substrate with a detachable layer and a polymeric layer, where the detachable layer dissolves within 72 hours of implantation, allowing for high therapeutic agent payloads and sustained release without compromising device integrity, utilizing materials like collagen and biodegradable polymers for the layers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a therapeutic coating is applied to an implantable device, then the device can deliver therapeutic agents, but the concentration of the therapeutic agent is limited and the device integrity is weakened
Solution Approach 1:
The device is segmented into a permanent implantable substrate and a temporary detachable layer. The therapeutic agent is loaded into the detachable layer which can be separated from the substrate after implantation. This segmentation allows high payload in the detachable layer without compromising the structural integrity of the permanent substrate, as the substrate does not need to contain or support the therapeutic coating.
Solution Approach 2:
The therapeutic agent delivery function is extracted from the permanent implantable substrate and placed into a separate detachable layer. This extracted layer can be optimized for high drug loading capacity while the substrate is optimized for mechanical strength. After delivery, the detachable layer is removed, leaving the intact substrate.
2Duration of action of moving object
If a therapeutic coating is applied to an implantable device, then the device can provide therapeutic effect, but the release duration is insufficient for prolonged treatment
Solution Approach 1:
The detachable layer is pre-loaded with high concentrations of therapeutic agent before implantation. This preliminary loading allows for an intense initial therapeutic effect. The layer is designed to deliver the full therapeutic payload over a specific duration, after which it is removed, ensuring consistent delivery without prolonged presence of degraded material.
Solution Approach 2:
The detachable layer is designed as a temporary delivery vehicle that is discarded after completing its therapeutic function. This allows for optimized short-term high-concentration delivery without the need for the permanent substrate to maintain therapeutic levels long-term. The discarded layer ensures consistent delivery during its functional period.
3Duration of action of stationary object
If a non-biodegradable mesh is implanted for hernia repair, then the device provides long-term structural support, but adhesion formation occurs at the implant site
Solution Approach 1:
The detachable layer serves as an intermediary between the permanent mesh substrate and the surrounding tissue. It provides a temporary barrier that prevents direct adhesion formation between the non-biodegradable mesh and tissue. After serving its protective function, the layer is removed, leaving the mesh in place for long-term structural support without permanent adhesion issues.
Solution Approach 2:
A temporary disposable layer is used to prevent adhesion during the critical early healing period. This short-living component is discarded after serving its protective purpose, allowing the permanent mesh to remain for structural support without causing adhesion. The disposable layer sacrifices itself to protect the long-term implant.
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
Enables high therapeutic agent payloads and sustained release over time without compromising the integrity of the medical device, facilitating effective treatment delivery while maintaining device stability and tissue integration.
Implementation Method 1
the detachable first layer is configured to dissolve within less than 72 hours of implantation
Implementation Method 2
the polymeric layer may also be attached to a portion of the medical device surface
Implementation Method 3
utilizing materials like collagen and biodegradable polymers for the layers
Data Source
Figure 1~2
Figure 3
Figure 4~5
AI summary
The present disclosure relates to self-detachable medical devices (210) containing a detachable film layer (220) and polymeric film layer (225).