Sealant Dressing with Removable Barrier for Moisture-Stable Hemostasis
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Solution Overview
Problem
Existing absorbable hemostatic patches with cross-linkable components face potency reduction in moist environments due to premature reaction, necessitating low moisture processing or separation methods that complicate use.
Innovation Solution
Incorporating a removable, inert barrier layer between co-reactive components to prevent interaction, allowing separation and reapproximation without additional steps, and using packaging to maintain separation until application.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If co-reactive components are placed in close proximity in the patch, then the patch can be applied quickly to the tissue site, but the co-reactive components may react prematurely in aqueous/moist environments reducing patch potency
Solution Approach 1:
A removable intermediate barrier layer is positioned between the two co-reactive components during storage and handling. This barrier layer acts as a physical separator that prevents premature interaction between the co-reactive components in aqueous/moist environments. When the device is removed from packaging, the barrier layer is removed, allowing the co-reactive components to be brought into contact with each other at the tissue site for rapid hemostatic action.
Solution Approach 2:
The patch is divided into two separate coated layers with co-reactive components, physically separated by an intermediate barrier layer during storage. This segmentation prevents premature reaction while allowing rapid approximation and reaction initiation upon application by simply removing the barrier layer and bringing the layers together.
2Reliability
If a barrier layer is placed between co-reactive components to prevent premature reaction, then patch potency is maintained, but the device structure becomes more complex
Solution Approach 1:
The intermediate barrier layer is integrated into the primary packaging material rather than being a separate component. This integration simplifies the overall device structure by eliminating the need for additional barrier layers or complex assembly mechanisms. The barrier layer is simply part of the packaging that is removed during normal application procedures.
Solution Approach 2:
The primary packaging material serves multiple functions: it protects the patch during storage, provides the intermediate barrier layer to prevent premature reaction, and facilitates easy removal of the barrier during application. This multi-functionality reduces overall device complexity by combining multiple roles into a single component.
3Reliability
If additional barrier layers are added to prevent premature reaction, then co-reactive components remain stable, but the number of procedural steps increases
Solution Approach 1:
The intermediate barrier layer is merged with the primary packaging material, eliminating the need for separate barrier layer application steps. The barrier function is combined with the packaging function, so that removing the packaging automatically removes the barrier layer and exposes the co-reactive components for application.
Solution Approach 2:
The packaging structure itself provides the barrier function without requiring additional components or steps. The barrier layer is inherently part of the packaging design, and its removal is automatically accomplished during the normal package opening process, requiring no additional user actions.
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
Maintains patch potency by preventing premature reaction, ensuring effective hemostasis with simplified application.
Implementation Method 1
an inert, removable separator barrier layer is positioned between the co-reactive components to function as a non-permeable and chemically inert physical barrier that prevents interaction
Implementation Method 2
Such separator layer can also serve as a desiccant to remove moisture from the dressing immediate environment
Data Source
AI summary
The present invention is directed to medical devices having a first porous substrate layer with at least a surface coating thereon of a first co-reactive component and a second substrate layer with at least a surface coating layer of a second co-reactive component that reacts with the first co-reactive component, and a removable barrier layer positioned between the first substrate layer and second substrate layer and in contact with said first substrate layer and said second substrate layer.