Coaxial Catheter PFO Closure Device
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Solution Overview
Problem
Current methods for closing patent foramen ovale (PFO) are invasive, risky, and often ineffective, with existing devices being complex, bulky, and unsuitable for precise deployment, leading to potential complications and recurrence of embolic events.
Innovation Solution
A mechanical closure device system comprising a deployment device with expandable anchors and a closure line, designed to be minimally invasive, allowing precise deployment through the septum primum and secundum to close the PFO, utilizing a coaxial tubular structure for flexibility and rigidity, and a method involving access to the right and left atria to position anchors and tension the closure line for effective sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional umbrella-like devices are used for PFO closure, then closure function is achieved, but device complexity and bulkiness increase, making precise deployment difficult
Solution Approach 1:
The closure device is divided into separate functional components: a delivery catheter, a self-expanding frame, and a closure element. This segmentation allows each component to be optimized independently - the frame provides structural support while the closure element delivers the sealing function, reducing overall device complexity while maintaining effectiveness.
Solution Approach 2:
The closure device components are nested within the delivery catheter during delivery, with the frame collapsed inside the catheter and the closure element contained within the frame. This nested configuration enables minimally invasive delivery through small access sites while allowing full deployment of the complex structure at the target PFO location.
2Reliability
If open heart surgery is used for PFO closure, then closure reliability is improved, but invasiveness and surgical risk increase
Solution Approach 1:
A delivery catheter serves as an intermediary device that guides the closure device through the venous system to the PFO location without requiring open surgical access. The catheter mediates between the external delivery system and the internal target site, enabling percutaneous delivery that avoids the harms of open heart surgery while maintaining closure reliability.
Solution Approach 2:
The self-expanding frame replaces complex mechanical deployment mechanisms, using elastic memory properties of the frame material to automatically expand to the deployed configuration upon release from the delivery catheter. This eliminates the need for complex mechanical actuation systems during deployment, reducing device complexity and improving reliability.
3Ease of operation
If pharmacological therapy is used, then treatment simplicity is improved, but side effects such as hemorrhage occur
Solution Approach 1:
The self-expanding frame utilizes the elastic memory properties of its material to automatically expand to the deployed configuration upon release from the delivery catheter, without requiring external mechanical actuation. This self-service mechanism simplifies the deployment process and eliminates the need for complex control systems, while the permanent implant provides durable closure that avoids ongoing pharmacological therapy and its associated hemorrhage risks.
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 provides a minimally invasive, effective, and precise method for closing PFO, reducing the risk of complications and recurrence of embolic events, while allowing for flexible deployment and anchoring to ensure proper tissue proximity for closure.
Implementation Method 1
The inner needle is constructed from a shape memory material and is designed to assume a curved shape when telescopically released from the outer needle
Implementation Method 2
The closure device is constructed from an elastic memory material and is designed to expand from a compressed delivery configuration to a deployed configuration
Data Source
AI summary
A device and method for deploying a mechanical closure device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The deployment device has a first tubular structure having proximal and distal ends. A second tubular structure is substantially coaxial to and slideably engaged within the first tubular structure. The second tubular structure has a first substantially linear shape when constrained within the first tubular structure, and a second curvilinear shape when telescopically extended from the distal end of the first tubular structure. A third tubular structure is substantially coaxial to and slideably engaged within the second tubular structure. The third tubular structure is configured to provide sufficient rigidity to push the mechanical closure device from the distal end of the second tubular structure, and provide sufficient flexibility to assume a curvilinear shape when deflected by the second tubular structure.