Malleable Polysaccharide Filler for Tissue Void Reconstruction
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Solution Overview
Problem
There is a need for improved materials and methods to fill surgical cavities or tissue voids created by procedures like lumpectomy or tumor removal, which allow for native tissue ingrowth and eventual resorption, while also providing a means for imaging markers to be integrated for visualization during medical procedures.
Innovation Solution
A malleable soft tissue filler is created by mixing beta-D-glucan with a second cross-linking polysaccharide, such as agarose, and lyophilizing the mixture to form a porous matrix that can be shaped to fit the cavity, with optional integration of imaging markers for medical imaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid open framework is used to facilitate tissue attachment, then tissue ingrowth is improved, but the device loses malleability and adaptability to different cavity shapes
Solution Approach 1:
The patent applies the dynamics principle by creating a filler that transitions from a rigid cross-linked gel structure to a malleable state through water absorption. The hydrogel absorbs body fluids after implantation, transforming from a firm structure to a softer, more adaptable form that can conform to irregular cavity shapes while maintaining its cross-linked framework for tissue attachment.
Solution Approach 2:
The patent utilizes parameter changes by controlling the water content and cross-linking degree of the hydrogel to achieve the desired balance between structural integrity and malleability. The filler's physical properties are adjusted through formulation parameters such as polysaccharide concentration and cross-linking agent ratio, allowing it to provide initial structural support then gradually soften to adapt to the cavity.
2Measurement precision
If imaging markers are integrated into the filler, then visualization during medical procedures is improved, but the device complexity increases
Solution Approach 1:
The patent applies the merging principle by integrating imaging markers directly into the hydrogel filler matrix during manufacturing. The markers are incorporated as discrete particles distributed throughout the filler material, combining the therapeutic filling function with the diagnostic imaging function into a single integrated device, thereby reducing overall system complexity.
3Ease of operation
If the filler material is made malleable for easy shaping, then ease of operation is improved, but structural integrity for tissue ingrowth may be compromised
Solution Approach 1:
The patent applies dynamics by creating a time-dependent mechanical property profile where the filler is initially malleable for easy shaping during implantation, then gradually develops or maintains structural integrity as it absorbs water and the cross-linked network becomes more established in the physiological environment.
Solution Approach 2:
The patent uses parameter changes in the water content of the hydrogel to control its mechanical properties. During implantation, the filler has lower water content providing higher strength for shaping. After implantation, water absorption increases flexibility and adaptability while the cross-linked framework maintains sufficient structural integrity for tissue ingrowth.
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 filler provides structural integrity for tissue ingrowth and resorption, while the imaging markers enable accurate visualization of the filled tissue void, facilitating surgical and therapeutic planning.
Implementation Method 1
a first cross-linking polysaccharide material and from about 0.01 percent by weight to about 0.3 percent by weight of a second cross-linking polysaccharide material
Implementation Method 2
lyophilizing the aqueous suspension; wherein the step of lyophilizing the aqueous suspension preferably includes first freezing the aqueous suspension to form a frozen aqueous suspension and then desiccating the frozen aqueous suspension
Implementation Method 3
allows native tissue ingrowth and healing, with eventual resorption or transformation of the material as native tissue grows in and replaces the removed tissue
Data Source
AI summary
A malleable polysaccharide soft tissue filler for filling tissue cavities or voids such as those resulting from tumor removal or other tissue resection. The soft tissue filler includes a first cross-linking polysaccharide, preferably a beta-D glucan, and a second cross-linking polysaccharide. The soft tissue filler is both porous and malleable and can be formed to accommodate the tissue cavity or void. The soft tissue filler can include an embedded marker for locating on medical imaging. Methods of making the soft tissue filler including lyophilizing an aqueous polysaccharide suspension are disclosed. The second cross-linking polysaccharide provides for increased structural integrity in a high-porosity and malleable soft tissue filler in which the respective cross-linking polysaccharides synergistically provide structural scaffolding for one another. Methods of use are also disclosed.