Biodegradable Septal Closure Device with Tissue Ingrowth and Apertures
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Solution Overview
Problem
Current treatments for septal defects, such as ventricular and atrial septal defects, often require invasive procedures and do not allow for future access through the sealed defect, as they do not adequately permit passage of medical devices after closure.
Innovation Solution
Design and manufacturing of medical devices with a framework and biodegradable tissue ingrowth members that promote tissue growth for sealing, while allowing for future access through apertures in the device, which can be made from biodegradable materials and include curved or spiral shapes to enhance tissue contact and device passage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a closure device is used to seal a septal defect, then the defect is sealed and blood flow is corrected, but future medical device access through the septum is blocked
Solution Approach 1:
The closure device is divided into multiple components including a first element, a second element, and a connector. The first and second elements form separate disc-like structures with tissue engagement features, while the connector allows relative movement between them. This segmentation enables the device to seal the defect effectively while maintaining flexibility for future access procedures.
Solution Approach 2:
The connector between the first and second elements is designed to allow relative movement between these elements. This dynamic capability enables the device to adapt during deployment and maintain sealing effectiveness while potentially allowing future devices to pass through by accommodating movement or deformation.
2Stability of the object's composition
If a closure device completely seals a septal defect, then tissue growth is promoted for permanent closure, but the ability to pass medical devices through the defect is lost
Solution Approach 1:
The first and second elements are designed with different local characteristics - they have tissue engagement features on their outer surfaces for promoting tissue growth and sealing, while their inner surfaces facing each other maintain gaps or spaces. This local differentiation allows tissue ingrowth for permanent closure while preserving pathways for future device access through the central regions.
Solution Approach 2:
The first and second elements incorporate porous or mesh-like structures on their tissue-facing surfaces to promote tissue ingrowth. These porous regions allow tissue to grow through and secure the closure permanently, while the overall device structure maintains central apertures or gaps that permit future medical device passage.
3Ease of manufacture
If traditional closure devices are used, then the procedure is simpler, but invasive follow-up procedures are required for future access
Solution Approach 1:
The closure device is designed with dual functionality: it provides effective sealing of the septal defect while simultaneously serving as a potential pathway for future device access. The first and second elements with their specific geometries and gaps allow the device to fulfill both the closure function and the future access function, eliminating the need for separate invasive procedures.
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 solution effectively seals septal defects while enabling future medical device access, reducing the need for invasive procedures and allowing for tissue ingrowth to secure the seal, with the option for biodegradation to minimize long-term obstacles.
Implementation Method 1
a biodegradable tissue ingrowth member extending over at least a portion of the framework, wherein the tissue ingrowth member is configured to promote tissue ingrowth thereupon, and wherein the tissue ingrowth is configured to seal an opening in the heart
Data Source
AI summary
An example closure device is disclosed. The closure device includes a framework including a first end region, a second end region and a medial region extending therebetween. The medical device also includes a biodegradable tissue ingrowth member extending over at least a portion of the framework, wherein the tissue ingrowth member is configured to promote tissue ingrowth thereupon, and wherein the tissue ingrowth is configured to seal an opening in the heart.