Shape Memory Wire Heart Occlusion Device
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Solution Overview
Problem
Current heart occlusion devices for conditions like PFO defects are complex to implant, prone to complications such as thrombus formation, conduction disturbances, and residual leaks, and lack anatomical conformability, leading to incomplete closure and potential adverse reactions.
Innovation Solution
A device comprising two flexible shape memory wires shaped into geometric forms with a waist that self-centers within the aperture, forming plates on either side of the defect to ensure complete closure, using a deployment mechanism that expands the wires to securely seat them against the septum.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If currently available septal closure devices are used, then occlusion of the defect can be achieved, but the devices lack anatomical conformability to the flap-like anatomy of PFOs, leading to incomplete closure
Solution Approach 1:
Instead of forcing a rigid or pre-formed device onto the PFO defect, the invention uses wires that are flexible and capable of being inverted or reconfigured to match the flap-like anatomy. The wires can be pushed through the defect and then shaped to conform to the septum primum and septum secundum, achieving complete closure by adapting to the natural anatomy rather than imposing a fixed geometry.
Solution Approach 2:
The invention employs shape memory material that can change its physical parameters (shape, flexibility) in response to environmental conditions such as temperature or physiological conditions in the body. This allows the device to transition from a compressed delivery state to an expanded conformable state, enabling it to adapt to the flap-like PFO anatomy and achieve complete occlusion.
2Ease of operation
If devices with a central post or self-centering mechanisms are used, then deployment is simplified, but the defect may not be closed completely
Solution Approach 1:
The invention removes the central post or self-centering mechanism from the device design. Instead, two separate flexible wires are used that can be independently positioned and shaped. This extraction of the centralizing element allows the wires to be pushed through the PFO defect and conform to the flap-like anatomy without being constrained by a rigid centering structure, thereby achieving complete closure.
Solution Approach 2:
The device is segmented into two separate flexible wires rather than a single integrated structure with a central post. This segmentation allows each wire to be independently manipulated and shaped to conform to the septal anatomy, enabling complete closure of the flap-like PFO defect while maintaining ease of deployment through the catheter.
3Reliability
If umbrella devices designed for ASDs are used to close PFOs, then patients can avoid anticoagulation therapy, but the devices are not optimally suited for PFO anatomy, resulting in technical complexity and complications
Solution Approach 1:
The invention uses flexible wires that can be easily delivered through a catheter and shaped to conform to the PFO anatomy. This flexible design simplifies the implantation process compared to rigid umbrella devices, while still providing effective occlusion that allows patients to avoid anticoagulation therapy. The wires can be pushed through the defect and shaped to match the flap-like structure without requiring complex deployment mechanisms.
4Reliability
If large masses of foreign material are used in closure devices, then occlusion is achieved, but unfavorable body adaptation and thrombus formation risk increase
Solution Approach 1:
The invention extracts or removes the large mass of foreign material used in traditional umbrella devices. Instead, only two thin flexible wires are introduced into the body to occlude the PFO defect. This minimal foreign material approach achieves effective occlusion while significantly reducing the risk of thrombus formation and improving body adaptation, as the wires can be shaped to conform to the anatomy rather than imposing a large artificial structure.
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 device achieves a high likelihood of complete defect closure with reduced risk of complications, improved anatomical conformability, and enhanced safety by minimizing foreign material exposure and hemodynamic disturbances.
Implementation Method 1
Each of the first and second wires is comprised of a shape memory material. Each of the first and second wires is shaped into first and second geometric forms separated by a waist
Data Source
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AI summary
Devices for occluding an aperture in tissue or a vessel comprise a first flexible wire and a second flexible wire. Each of the first and second wires is comprised of a shape memory material. Each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane. The first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire. Methods for occluding an aperture in tissue or a vessel using such devices are also provided.