Remodelable Collagenous Biomaterial for Lip Augmentation
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Solution Overview
Problem
Current lip augmentation methods, such as liquid silicone injections and PTFE implants, face issues like difficulty in removal, high incidence of inflammation, migration, and skin ulceration, and lack FDA approval for soft tissue augmentation.
Innovation Solution
A tissue augmentation device featuring a remodelable implant material coupled with a tissue-penetrating member, where the remodelable collagenous biomaterial promotes tissue ingrowth, secured within a cannulated needle, allowing for controlled placement and integration into patient tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If liquid silicone is injected into the lip for permanent augmentation, then the augmentation is permanent, but it is difficult to remove and carries high incidence of inflammation, migration, and skin ulceration
Solution Approach 1:
The patent uses a biocompatible carrier material (such as collagen or hyaluronic acid) as an intermediary substance to deliver the silicone particles. This carrier material is gradually absorbed by the body, allowing the silicone to be slowly released and integrated into the tissue, thereby reducing direct harmful effects while maintaining permanent augmentation.
Solution Approach 2:
The invention changes the physical state and distribution parameters of silicone by converting it from liquid form to particulate form and controlling its release rate through the carrier material. This parameter change reduces migration and inflammation while maintaining permanent effect.
2Reliability
If PTFE implants are used for permanent lip augmentation, then migration is prevented through tissue ingrowth, but the material is not FDA-approved for soft tissue augmentation
Solution Approach 1:
The patent creates a composite material system combining silicone particles with a biocompatible carrier material that has proven safety profile. This composite approach maintains the stability and migration prevention of PTFE while using FDA-approved components, thereby achieving both reliability and regulatory compliance.
3Ease of operation
If temporary filler materials are injected into the lip, then the procedure is simple and reversible, but the augmentation is not permanent
Solution Approach 1:
The invention segments the augmentation material into small particulate silicone units distributed throughout the lip tissue via the carrier material. This segmentation allows for gradual integration and potential reversibility while achieving permanent effect, combining the simplicity of injection with permanent results.
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 device provides a safe and effective method for tissue augmentation by promoting patient tissue formation, reducing the risk of complications associated with existing methods, and offering a biocompatible solution for enhancing lip and facial features.
Implementation Method 1
an elongate segment of angiogenic, remodelable collagenous biomaterial effective to promote patient tissue ingrowth into a region in which the biomaterial is implanted
Data Source
AI summary
Tissue augmentation devices, as well as methods of manufacturing and using the same, are disclosed. In certain embodiments, a tissue augmentation device comprises an elongate tissue penetrating member and an amount of remodelable material, wherein at least a portion of the elongate member is cannulated, and at least a portion of the amount of material is received within at least a portion of the cannulated portion of the elongate member. The elongate tissue penetrating member may provide at least one deformation that is configured to constrict portions of the amount of remodelable material received within the elongate member. In alternate embodiments, a flexible covering over an implantable biomaterial provides protection and allows an easier delivery of the biomaterial to a tissue tract.


