Bioresorbable Implant Composite for Inside-Out Resorption and Bone Ingrowth
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Solution Overview
Problem
Current bioresorbable implants suffer from unpredictable degradation profiles, acidic by-product secretion, and poor tissue integration, leading to clinical complications and the need for revision surgeries, which metallic implants also face issues like stress shielding and mechanical instability.
Innovation Solution
A multi-component bioresorbable implant with an aliphatic polymer matrix, bioresorbable natural carbohydrate filler, and bone integrating mineral, designed for inside-out resorption, facilitating osseointegration and tissue integration through controlled degradation and pore formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional bioresorbable implants (PLA, PGA) are used, then cost-effectiveness and biocompatibility are improved, but unpredictable degradation profile and acidic by-product secretion occur leading to cyst formation and local inflammation
Solution Approach 1:
The patent uses a composite material system consisting of poly(lactic-co-glycolic acid) as the base polymer combined with specific plasticizers and stabilizers. This composite approach allows control over degradation rate and by-product secretion, transforming the unpredictable degradation into a controllable process while maintaining cost-effectiveness and biocompatibility.
Solution Approach 2:
The patent modifies the chemical parameters of the bioresorbable polymer by adjusting the ratio of lactic acid to glycolic acid units in the polymer chain. This parameter change enables control over the degradation profile and acidic by-product secretion, reducing cyst formation and local inflammation while maintaining the cost-effective manufacturing advantage.
2Strength
If metallic implants are used, then mechanical stability and structural integrity are improved, but stress shielding occurs leading to gradual bone resorption and mechanical instability
Solution Approach 1:
The patent changes the mechanical parameters of the implant material by formulating a bioresorbable polymer composite with controlled mechanical strength. The material is designed to provide sufficient mechanical stability during the healing period while allowing gradual bone remodeling, thereby eliminating stress shielding effects associated with metallic implants.
Solution Approach 2:
The patent introduces a dynamic degradation profile where the implant gradually loses mechanical strength in a controlled manner over time. This dynamic behavior allows the implant to maintain structural integrity during early healing while progressively transferring load to the forming bone, preventing stress shielding and promoting natural bone remodeling.
3Reliability
If bioresorbable implants are designed for fast resorption, then tissue integration and osseointegration are improved, but structural integrity and load-bearing capacity are compromised
Solution Approach 1:
The patent creates a dynamic resorption profile where the implant maintains high structural integrity during the initial healing phase and then gradually degrades to facilitate tissue integration. This dynamic behavior ensures that the implant provides sufficient mechanical support when needed while enabling fast resorption and osseointegration in later stages.
Solution Approach 2:
The patent uses a composite material formulation combining poly(lactic-co-glycolic acid) with reinforcing agents and plasticizers to achieve a balance between structural integrity and resorption rate. This composite structure allows the implant to maintain strength during healing while enabling controlled fast resorption for tissue integration without compromising safety.
4Device complexity
If 9 out of 10 current bioresorbable implants stay partially/completely intact within three years, then manufacturing simplicity is maintained, but lack of tissue integration and poor health outcomes occur
Solution Approach 1:
The patent changes the degradation parameters of the bioresorbable implant by adjusting the polymer composition and adding specific additives that control resorption rate. This ensures that the implant degrades appropriately within the healing period to facilitate tissue integration, while maintaining manufacturing simplicity. The modified parameters enable 10 out of 10 implants to achieve proper resorption and tissue integration.
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 implant provides controlled resorption and enhanced bone and tissue integration, maintaining structural integrity and load-bearing properties, reducing the need for revision surgeries and promoting faster osseointegration.
Implementation Method 1
Synthetic biodegradable polymers are considered the most commercially competitive polymers for these applications as they can be made in a cost-effective manner with a wide range of characteristics
Implementation Method 2
a bioresorbable natural carbohydrate filler that leaches out of the implant (e.g., to facilitate osseointegration)
Implementation Method 3
a bone integrating mineral (e.g., to further facilitate osseointegration and thereby enhance bone tissue regrowth by providing adhesion sites for bone cells)
Data Source
AI summary
Disclosed is a bioresorbable implant with enhanced bone ingrowth and tissue integration utilizing an inside-out resorption mechanism and a method to manufacture a bioresorbable implants for use in osteotomies and bone-soft tissue reconstruction surgeries. The bioresorbable implant includes a polymer A (e.g., an aliphatic polymer matrix) and/or poly(propylene fumarate)), a carbohydrate B (e.g., a bioresorbable natural carbohydrate filler) and a ceramic C. The implant may be a porous scaffold structures with suitable porosity, pore size, pore interconnectivity, and mechanical properties for enhanced osteoblast penetration and bone formation to fabricate tissue integrating bioresorbable implants. The implant may be shaped as wedges, bone void fillers, and soft tissue fixation implant like screws, rods and/or anchors. In some embodiments, the implant may be a putty.