Inflatable Occluder Scaffold for Septal Defect Closure
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Solution Overview
Problem
Current septal closure devices for patent foramen ovale (PFO) have high complication rates, complex implantation procedures, and lack anatomical conformability, often requiring anticoagulation therapy with adverse side effects, and are difficult to manufacture consistently.
Innovation Solution
An inflatable occluder with a scaffold and injection port, made from biocompatible materials, that expands to occlude septal defects, featuring a structural member for optimal shape and adhesion to heart tissue, allowing percutaneous transluminal delivery and potential bioresorption.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional septal closure devices are used, then PFO closure is achieved, but complication rates are high and anatomical conformability is poor
Solution Approach 1:
The device changes its physical state from compressed to expanded by altering the volume of injectable material within the scaffold, allowing it to adapt to the PFO anatomy and achieve secure closure while minimizing complications
Solution Approach 2:
The scaffold is constructed as a flexible, porous structure that can conform to the irregular anatomy of the PFO, providing better contact and sealing compared to rigid traditional devices
2Reliability
If traditional septal closure devices are used, then PFO closure is achieved, but implantation procedures are complex
Solution Approach 1:
The device is divided into modular components including the scaffold and injectable material, allowing for simplified delivery through catheter-based percutaneous access and stepwise deployment
Solution Approach 2:
The device utilizes fluid injection through the injection port to expand the scaffold in situ, eliminating the need for complex mechanical deployment mechanisms and reducing procedural complexity
3Reliability
If traditional septal closure devices are used, then PFO closure is achieved, but manufacturing consistency is difficult
Solution Approach 1:
The scaffold's porosity and mechanical properties can be adjusted by changing the concentration or type of injectable material, allowing for standardized manufacturing processes that produce consistent device performance
Solution Approach 2:
The combination of scaffold structure and injectable material creates a composite system where the material properties can be optimized during manufacturing to ensure consistent device behavior and closure effectiveness
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 inflatable occluder provides a simpler, safer, and more effective method for closing PFOs with reduced complications, improved anatomical conformability, and lower manufacturing complexity, potentially eliminating the need for anticoagulation therapy.
Implementation Method 1
The scaffold may be any geometry, including square, polygonal, substantially circular, or non-circular. The scaffold, when inflated, is sized and shaped to occlude a PFO.
Implementation Method 2
The scaffold also has at least one structural member that provides a structure to the scaffold such that, when the channels are inflated, the scaffold adopts a shape that is capable of occluding a septal defect
Data Source
AI summary
An implant for occluding a septal defect, such as a patent foramen ovale (PFO), and methods of delivering the implant are described. The implant includes a scaffold, at least one channel, and an injection port in fluid communication with the channels for inflating the scaffold.