Biodegradable PFO Occluder With Stabilizing Wire for Septal Fit
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current biodegradable occluders for patent foramen ovale (PFO) suffer from poor mechanical properties, leading to inadequate fitting and occluding effects, and risk of residual blood shunts due to poor compliance and recovery, which complicates endothelialization.
Innovation Solution
The occluder design includes a proximal disc with a bending area and a stabilizing wire that enhances fitting and occluding effects by providing a centripetal force, ensuring stable adherence to the interatrial septum, and features a distal disc with complementary bending areas for improved clamping and fitting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If biodegradable material is used for the occluder, then the occluder becomes degradable and can be completely metabolized by the human body, but the mechanical properties are poor leading to inadequate compliance and recovery
Solution Approach 1:
The patent employs composite materials by combining degradable polymer material with a metal stabilization wire. The degradable polymer provides biodegradability and metabolic compatibility, while the metal stabilization wire reinforces the structural integrity, compliance, and recovery properties. This composite structure allows the occluder to maintain mechanical strength during the critical healing period while ultimately degrading completely in the body.
2Reliability
If the occluder is made with poor mechanical properties, then it can be biodegradable, but the compliance and recovery are poor resulting in inadequate fitting to the cardiac septal defect
Solution Approach 1:
The composite structure of degradable polymer and metal stabilization wire enables the occluder to achieve both biodegradability and precise fitting. The metal wire provides the necessary rigidity and shape memory for accurate positioning and fitting to the cardiac septal defect, while the degradable polymer maintains compatibility with body tissues and enables complete metabolism over time.
Solution Approach 2:
The patent utilizes parameter changes in the degradable polymer material, specifically controlling the degradation rate and mechanical property evolution over time. The material parameters are designed to maintain sufficient strength and compliance during the initial healing period, then gradually degrade as the tissue integrates and the occluder is absorbed by the body.
3Reliability
If the occluder does not fit well to the cardiac septal tissue, then endothelialization process is compromised, but improving fit requires better mechanical properties which conflicts with biodegradability
Solution Approach 1:
The composite material structure addresses the endothelialization challenge by providing a surface that combines the biodegradability of polymer with the structural stability needed for tissue integration. The metal stabilization wire ensures proper fitting and geometric stability during the critical endothelialization period, while the degradable polymer surface promotes tissue compatibility and eventual complete absorption.
4Stability of the object's composition
If nickel-titanium alloy is used for the occluder, then good shape memory properties are achieved, but the material is non-degradable and carries risk of metal ion leaching
Solution Approach 1:
The patent adopts the principle of using a temporary, degradable occluder that is meant to be absorbed by the body over time. The degradable polymer material is selected to provide sufficient functional performance during the healing period, then completely degrades and is metabolized, eliminating the long-term presence of foreign material and associated risks of metal ion leaching.
Solution Approach 2:
The composite structure combines the temporary structural support needed for shape memory functionality with a degradable polymer matrix that eliminates long-term material presence. The metal stabilization wire provides the necessary shape memory properties during implantation and healing, then becomes part of the degrading composite structure that is completely metabolized.
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 design ensures stable fitting and occluding effects, promotes rapid endothelialization, and prevents residual shunts by enhancing the occluder's ability to maintain its shape and size post-implantation, thereby improving the occluding performance and safety.
Implementation Method 1
a stabilizing wire is further threaded through a free end of the proximal bending area and able to tighten the free end of the proximal bending area towards the waist portion
Implementation Method 2
the proximal bending area is provided as a part mainly used for providing a locking force so that the recovering effect of the shape of the proximal disc surface may be increased
Data Source
AI summary
The present application discloses an occluder, including a distal disc, a waist portion, and a proximal disc which are formed in sequence. The proximal disc includes a proximal disc surface. A proximal bending area is formed at a circumference of the proximal disc surface and bent towards the distal disc, where the proximal bending area surrounds an edge of the distal disc, and a stabilizing wire is further threaded through a free end of the proximal bending area and may tighten the free end of the proximal bending area towards the waist portion.