Silicone Gel Island Dressings With Pre-Perforated Support Layers
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Solution Overview
Problem
Existing wound dressing manufacturing processes that involve perforating silicone gel layers result in undesirable ring-shaped elevations and occlusion issues, leading to non-homogeneous contact with the skin or wound, and require lengthy stabilization periods.
Innovation Solution
A continuous process involving ultrasonic perforation of a support layer with a deformable template layer, followed by dispensing an uncured silicone mixture onto the non-perforated areas, and curing it to create a silicone gel layer with aligned openings without displacing the gel, thereby avoiding direct perforation of the silicone.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If the silicone gel layer is directly perforated by ultrasonic perforation elements, then openings are created for fluid flow, but ring-shaped elevated areas form around the perforations causing non-homogeneous contact
Solution Approach 1:
The support layer is perforated in advance before the silicone gel is applied. This preliminary perforation allows the gel to be dispensed into pre-formed recesses, preventing the formation of ring-shaped elevations and ensuring homogeneous contact with the skin or wound surface.
Solution Approach 2:
Instead of perforating the silicone gel layer directly, the invention inverts the sequence by first perforating the support layer and then applying the gel. This reverse approach eliminates the displacement and aggregation problems that occur when gel is perforated directly.
2Reliability
If a deformable template layer is used to maintain perforation shape, then stable openings are achieved, but lengthy stabilization periods of at least 12 hours are required
Solution Approach 1:
The invention utilizes the phase transition of the silicone material from a viscous uncured state to a cured gel state. By dispensing the uncured silicone mixture into the recesses and then curing it, stable openings are achieved immediately without requiring lengthy stabilization periods. The curing process locks the gel in place, preventing flow-back and maintaining perforation stability.
Solution Approach 2:
The invention changes the physical state parameter of the silicone from uncured (viscous) to cured (gel) through a curing process. This parameter change allows the material to maintain its shape and position in the perforations without requiring extended stabilization time, as the curing process rapidly establishes structural stability.
3Manufacturing precision
If silicone gel is displaced by perforation elements, then openings are created, but the gel aggregates as elevated donuts around the perforation elements
Solution Approach 1:
The support layer is perforated in advance before the silicone gel is applied. This preliminary perforation creates recesses that guide the gel into the correct positions, preventing displacement and aggregation. The gel is dispensed into pre-formed cavities rather than being pushed aside by protruding elements.
Solution Approach 2:
The support layer acts as an intermediary between the perforation elements and the silicone gel. The perforation elements perforate the support layer without directly contacting the gel. The gel is then dispensed into the recesses formed in the support layer, eliminating direct displacement and aggregation issues.
4Stability of the object's composition
If the silicone gel is cured after perforation, then stable structure is achieved, but the gel flows back into perforations during the curing process
Solution Approach 1:
The support layer is perforated and the uncured silicone mixture is dispensed into the recesses before curing takes place. This preliminary positioning ensures that the gel is already in the correct locations before the curing process begins, preventing flow-back and maintaining precise alignment of openings throughout curing.
Solution Approach 2:
The invention exploits the phase transition from uncured viscous silicone to cured gel. By dispensing the uncured material into the recesses and then initiating curing, the gel sets in place during the phase transition, preventing flow-back and maintaining structural stability and openings alignment simultaneously.
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
The process ensures a laterally homogeneous silicone adhesive layer with aligned openings, minimizing elevations and eliminating the need for lengthy stabilization periods, resulting in a more effective and efficient wound dressing production.
Implementation Method 1
feeding at least a template layer and a support layer through an ultrasonic perforation device, which ultrasonic perforation device comprises a plurality of perforation elements... and which device is configured to introduce perforations... into at least said support layer; wherein the perforating elements perforate the support layer, while, at the same time, deform the template layer without perforating the same
Implementation Method 2
at least partially curing the silicone mixture from step (B) to result in an at least partially cured silicone gel, preferably while the laminate from step (B) at least partially rotates on a heated rotating drum
Data Source
Figure 1
Figure 2
Figure 3a~3c
AI summary
The present invention relates to an improved process for the manufacture of wound dressings, in particular so-called "island dressings", i.e., dressings that comprise a laminate of layers of different functionalities including (but not limited to) a backing layer, an absorbent pad, a support layer, and a skin or wound facing adhesive layer comprising a silicone gel. The process according to the invention avoids any perforation of the silicone gel. The process results in a wound dressing with superior performance properties, including improved lateral homogeneity of the wound-facing silicone adhesive layer.