Hexagonal Occlusion Clip for Minimally Invasive Atrial Appendage Closure
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Solution Overview
Problem
Existing treatments for atrial fibrillation, such as pharmaceutical regimens and invasive surgeries, are inadequate for preventing thrombus formation in the left atrial appendage due to suboptimal efficacy and patient compliance, and invasive surgeries pose risks and complications.
Innovation Solution
A minimally invasive occlusion clip with a resilient base strip and core elements that compress tissue to occlude fluid flow, using a hexagonal profile and actuator cables for controlled closure, allowing for secure attachment and repositioning without tissue laceration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If invasive surgeries are used to occlude the LAA, then the occlusion effectiveness is improved, but the surgical risk and patient trauma increase
Solution Approach 1:
The patent introduces a minimally invasive delivery system that acts as an intermediary to deploy the occlusion device through a catheter approach. The delivery system includes a catheter with a deployment mechanism that can be inserted through a peripheral vessel and positioned at the LAA, avoiding the need for open surgical exposure while still achieving effective occlusion. This intermediary delivery mechanism resolves the contradiction by providing a less invasive pathway to achieve reliable occlusion.
2Reliability
If compressive force is increased to ensure occlusion, then the occlusion reliability is improved, but the risk of tissue laceration increases
Solution Approach 1:
The occlusion device incorporates a dynamic compression mechanism where the compressive force can be adjusted and controlled during deployment. The device includes a mechanism that allows the operator to progressively increase compression to achieve occlusion while monitoring tissue response, and to release or adjust compression if signs of excessive force appear. This dynamic control resolves the contradiction by allowing optimization of compression force in real-time to achieve reliable occlusion without causing tissue damage.
Solution Approach 2:
The device utilizes materials and structural design that allow compression force to be distributed and modulated. The occlusion element is designed with specific mechanical properties that enable it to conform to tissue geometry and distribute pressure evenly, preventing localized excessive force that could cause laceration while maintaining overall compression sufficient for occlusion. This parameter optimization resolves the contradiction between achieving reliable occlusion and preventing tissue damage.
3Object-affected harmful factors
If a minimally invasive approach is used, then patient trauma is reduced, but the complexity of precise delivery and positioning increases
Solution Approach 1:
The patent employs a specialized delivery system with visual guidance and positioning aids as intermediaries to simplify the minimally invasive procedure. The delivery catheter includes markers, visual indicators, and mechanical guidance features that help the operator navigate and position the occlusion device accurately through the catheter approach. This intermediary delivery system resolves the contradiction by providing tools that make the complex minimally invasive procedure more manageable while maintaining its low-trauma advantage.
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 occlusion clip effectively occludes the left atrial appendage, reducing thrombus formation and stroke risk while minimizing patient trauma and surgical complications.
Implementation Method 1
a base configured to apply compressive force against a first of the two walls; and at least one opposing member configured to apply compressive force against a second of the two walls
Implementation Method 2
Two walls of tissue are compressed together with sufficient compressive force to prevent fluid flow between the two walls
Data Source
AI summary
An occlusion clip is disclosed herein. The occlusion clip comprises a resilient base strip including a plurality of base strip segments defining a hexagonal profile that represents an open state of the occlusion clip. A plurality of housing segments is provided on each of the base strip segments. A core element is disposed and extends within the housing segments defining a half of the hexagonal profile, wherein the core element is configured for linear movement within the housing segments. An actuator cable extends from each of the core elements, wherein in an actuated state, the core element is pulled via the actuator cable, and the pulling facilitates relative movement between the housing segments and the core elements causing the core element to make the housing segments collinear, thereby defining a closed configuration of the occlusion clip.