Tissue-Integration Device With Interconnected Pores
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Solution Overview
Problem
Commercially produced surgical fixation tools injection molded with a polymer and growth-promoting medium lack control over the distribution of the medium, resulting in it being locked subsurface and unavailable for bone ingrowth or regrowth.
Innovation Solution
A method of manufacturing a tissue-integration device involving overlapping layers of porous sheet material, with controlled pore pathways and growth-promoting medium distribution, achieved through layer orientation, lamination, and precise application of pressure and heat.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If injection molding is used to manufacture fixation devices with growth-promoting medium, then the device can be mass-produced with consistent shape and structure, but the distribution of growth-promoting medium becomes uncontrolled and it gets locked subsurface where it is unavailable for bone ingrowth
Solution Approach 1:
The device is divided into multiple layers with distinct functions: outer layers provide structural integrity and shape consistency for mass production, while inner layers contain controlled pore structures that guide growth-promoting medium distribution. This segmentation allows each layer to be optimized independently while maintaining overall manufacturing efficiency.
Solution Approach 2:
Different regions of the device are assigned different properties: subsurface regions maintain dense polymer structure for mechanical strength and consistent molding, while controlled pore pathways are created in specific zones to enable targeted growth-promoting medium distribution and bone ingrowth without compromising overall structural integrity.
2Stability of the object's composition
If growth-promoting medium is mixed with polymer resin for injection molding, then the device has consistent material composition, but the medium is locked in place and not readily available for decalcification and bone regrowth
Solution Approach 1:
The growth-promoting medium is extracted from the bulk polymer matrix and placed into dedicated pore structures and channels within the device. This separation allows the medium to remain stable within controlled pathways while being readily accessible for decalcification and bone regrowth, eliminating the locking effect of the polymer resin.
Solution Approach 2:
The pore structure acts as an intermediary between the polymer matrix and the growth-promoting medium. The pores provide a controlled environment that maintains material composition consistency while enabling selective accessibility of the medium to bone tissue, facilitating controlled decalcification and regrowth.
3Ease of operation
If porous sheet material layers are overlapped to create interconnected pores, then pathways for tissue ingrowth are created, but the device complexity increases
Solution Approach 1:
Multiple porous layers are merged through lamination to create a three-dimensional network of interconnected pores. This merging process integrates the pore pathways from individual layers into a unified structure that provides extensive tissue ingrowth pathways while maintaining manageable complexity through systematic layer arrangement.
Solution Approach 2:
The pore structure transitions from two-dimensional patterns in individual sheets to three-dimensional interconnected pathways through layer stacking. This dimensional transformation creates complex tissue ingrowth pathways without requiring complex manufacturing processes, as the complexity emerges naturally from the layered assembly.
4Strength
If pressure and heat are applied to laminate layers together, then mechanical properties and structural integrity are enhanced, but the growth-promoting medium distribution may be compromised
Solution Approach 1:
The growth-promoting medium is pre-loaded into the pore structures before the lamination process. This preliminary action ensures that the medium is securely positioned within the pore pathways before pressure and heat are applied, preventing displacement or loss of distribution precision during the bonding process.
Solution Approach 2:
The lamination parameters (pressure, temperature, time) are carefully controlled and optimized to bond the layers effectively while maintaining the integrity of the growth-promoting medium distribution. By adjusting these parameters, strong interlayer bonding is achieved without compromising the precise medium placement within the pores.
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 method ensures precise distribution of the growth-promoting medium and enhanced mechanical properties, facilitating controlled tissue integration and adhesion by creating pathways for tissue ingrowth within the device.
Implementation Method 1
compressing the layers together to at least partially laminate the layers of the device
Implementation Method 2
compressing the layers together to at least partially laminate the layers of the device
Implementation Method 3
applying heat to the sheet material during the compression step
Data Source
AI summary
The present invention is concerned with a method of manufacturing a tissue-integration device, and a tissue-integration device so produced, the method comprising the steps of wrapping a porous sheet of material around a mandrel in order to create overlapping layers of the porous sheet material, the wrapped mandrel then being placed in a mould in order to apply pressure and heat to the overlapping layers in order to effect the lamination thereof such as to form a device having spaces defined by overlapping pores of the adjacent layers.