Bioabsorbable Composite Device Accelerated Degradation
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Solution Overview
Problem
Current bioabsorbable medical devices lack the ability to achieve a desired mass loss through accelerated degradation after they have fulfilled their functional purpose, necessitating additional surgical interventions for removal and potentially causing stress to surrounding tissues during healing.
Innovation Solution
Development of medical devices made from composite structures comprising biodegradable and bioabsorbable materials with varying degradation rates, including blends, coatings, and encapsulated degradation additives, which enable accelerated mass loss after the device has completed its functional effect, such as a stent with a rapid-degrading core and slower-degrading outer layer, allowing for controlled drug release and tissue integration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a bioabsorbable medical device is made from a single biodegradable polymer material, then the device can be completely absorbed by the body, but the degradation rate is slow and uniform, requiring additional surgical intervention for removal
Solution Approach 1:
The medical device is divided into multiple segments or layers, each composed of different biodegradable polymers with distinct degradation rates. The device includes a first biodegradable polymer component and a second biodegradable polymer component, where the first component degrades faster than the second component, enabling staged degradation and eliminating the need for surgical removal.
Solution Approach 2:
The medical device employs a composite structure made from multiple biodegradable polymer materials with different degradation characteristics. This composite approach allows the device to exhibit both fast and slow degradation phases, achieving complete absorption within a desired time frame while maintaining structural integrity during the functional period.
2Strength
If a rigid nonbiodegradable implant is used to fixate a fractured bone, then the bone can be stabilized during healing, but the bone cannot carry sufficient load and may suffer refracture upon removal
Solution Approach 1:
The medical device transitions from a static, nonbiodegradable implant to a dynamic, staged-degradation system. The device provides rigid support initially through the slower-degrading polymer component, then gradually transfers load to the healing bone as the faster-degrading component breaks down, enabling adaptive load transfer that promotes bone strength development.
Solution Approach 2:
The device utilizes changes in material degradation parameters over time to alter its mechanical properties. As the first biodegradable polymer degrades faster than the second, the device's stiffness and load-bearing capacity change dynamically, allowing initial rigid fixation followed by progressive load transfer to the healing bone.
3Ease of operation
If a bioabsorbable device is designed to degrade completely, then no second surgery is needed for removal, but the device lacks control over degradation timing and rate
Solution Approach 1:
Different regions or components of the medical device are assigned different degradation rates through the use of distinct biodegradable polymer materials. The first biodegradable polymer component degrades at a different rate than the second component, allowing precise control over the degradation timeline and enabling complete absorption without surgical intervention.
Solution Approach 2:
The device is designed with predetermined degradation characteristics built into its composite structure before implantation. The differential degradation rates of the multiple polymer components are engineered in advance to achieve complete absorption at a specific time point, eliminating the need for surgical removal while maintaining precise control over the degradation process.
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
Enables the medical device to be completely absorbed by the body after its functional purpose is achieved, reducing the need for additional surgeries and minimizing tissue stress, while allowing for programmed drug release and enhanced biocompatibility.
Implementation Method 1
These bulk eroding materials breakdown over time due to chemical hydrolysis to produce water-soluble, low molecular weight fragments. These fragments are then attacked by enzymes to produce lower molecular weight metabolites.
Data Source
AI summary
A medical device has a structure made of a first biodegradable and/or bioabsorbable material and a second biodegradable and/or bioabsorbable material encapsulating a degradation additive incorporated into the first biodegradable and/or bioabsorbable material. The second biodegradable and/or bioabsorbable material has a degradation rate that is faster than the degradation rate of the first biodegradable and/or bioabsorbable material such that the structure experiences a period of accelerated degradation upon release of the degradation additive following sufficient degradation of the second biodegradable and/or bioabsorbable material.