Implantable Frame with Variable Compliance via Fracture
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Solution Overview
Problem
Current implantable medical devices face challenges in balancing compliance with the dynamic shape of body vessels and providing optimal mechanical loading for remodelable materials, as they often have fixed compliance that does not change over time, leading to trade-offs between minimizing vessel distortion and promoting remodeling processes.
Innovation Solution
The development of a medical device with a frame that has variable compliance over time, achieved through controlled fracturing or bioabsorption of materials, allowing for increased compliance during remodeling and reduced compliance post-remodeling, while minimizing vessel distortion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the frame is made highly compliant to conform to the dynamic shape of the body vessel, then the device can adapt to vessel shape changes, but the device cannot provide adequate mechanical loading for remodelable material
Solution Approach 1:
The frame transitions from a static compliance state to a dynamic one by incorporating materials that change their mechanical properties over time. The frame initially provides high compliance to match the dynamic vessel shape, then progressively increases its stiffness through material degradation or phase transformation, ultimately achieving variable compliance without requiring multiple discrete components.
Solution Approach 2:
The frame's compliance parameter is changed over time through the use of materials that undergo degradation, resorption, or phase transformation. This allows the mechanical properties of the frame to evolve from a compliant state to a stiffer state, providing different levels of support at different stages of the remodeling process.
2Force
If the frame provides optimal mechanical loading for remodeling, then the remodeling process is enhanced, but the frame causes excessive vessel distortion
Solution Approach 1:
The frame is designed to provide enhanced mechanical loading during the critical early stages of remodeling when the tissue is most vulnerable. As remodeling progresses and tissue strength increases, the frame's compliance increases accordingly, reducing the mechanical load to prevent over-stressing the regenerated tissue and minimizing vessel distortion.
Solution Approach 2:
The frame's mechanical properties are made dynamic to match the evolving needs of the remodeling tissue. The frame transitions from a stiffer state that provides strong mechanical support during early remodeling to a more compliant state that accommodates the strengthened tissue, thereby optimizing mechanical loading throughout the entire remodeling process.
3Device complexity
If the frame maintains fixed compliance, then the device structure is simple, but the device cannot adapt to changing remodeling requirements over time
Solution Approach 1:
The frame performs the function of adapting its compliance automatically through the inherent degradation or transformation properties of its materials. The frame self-regulates its mechanical properties in response to the biological environment and remodeling progress, eliminating the need for complex external control mechanisms or multiple interchangeable components.
Solution Approach 2:
The frame incorporates composite materials that combine different phases or components with distinct degradation rates or mechanical properties. This allows the frame to exhibit time-dependent compliance behavior, transitioning from an initially compliant state to a stiffer state as the removable phase degrades or transforms, thereby adapting to changing remodeling requirements.
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 optimal tension on remodelable materials during the remodeling process and minimal vessel distortion after completion, providing a balanced solution for both compliance and mechanical loading.
Implementation Method 1
the frame comprises a portion that fractures in a controlled manner to increase the compliance of the frame
Implementation Method 2
the frame comprises a bioabsorbable material, the bioabsorption of which increases the compliance of the frame
Data Source
AI summary
Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. Embodiments of the invention relate to medical devices comprising a frame having a compliance that can change upon implantation of the medical device within the lumen of a body vessel. Controlled fracture or bioabsorption of frame material can, in some embodiments, increase the compliance of a frame after implantation. Medical devices comprising a frame and one or more valve members adapted to regulate fluid flow in a body vessel, such as a vein, are also provided.