Left Atrial Appendage Twisting Implant for Secure Occlusion
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Solution Overview
Problem
Conventional LAA closure devices face issues such as complicated sizing algorithms, implant migration, leakage, fracture, and high thrombus incidence, necessitating prolonged anticoagulation and follow-up procedures.
Innovation Solution
Devices and methods involving an implant with a contact member that rotates and engages the LAA wall, a securing element to prevent reverse rotation, and a self-expanding mechanism to securely twist and occlude the LAA, reducing the risk of thrombus formation and simplifying procedural requirements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional LAA closure devices are used, then LAA occlusion can be achieved, but device complexity increases due to complicated sizing algorithms and multiple procedural requirements
Solution Approach 1:
The device employs a shape memory alloy contact member that changes its physical state from constrained to self-expanded, altering its parameters (size, shape, rigidity) to achieve LAA occlusion without requiring complex sizing algorithms. The phase transition of the shape memory alloy simplifies the deployment process while maintaining reliability.
Solution Approach 2:
The contact member is designed to self-expand upon delivery to the LAA, automatically performing the occlusion function without requiring complex external manipulation or multiple procedural steps. This self-service mechanism reduces device complexity and procedural requirements while ensuring reliable LAA closure.
2Reliability
If conventional LAA closure devices are used, then LAA occlusion can be achieved, but the risk of thrombus formation increases requiring prolonged anticoagulation
Solution Approach 1:
The contact member is covered with an endothelialized membrane that provides a biocompatible surface, reducing thrombus formation risk. The flexible membrane allows natural blood flow patterns while preventing clot adhesion, thereby maintaining occlusion effectiveness without requiring prolonged anticoagulation therapy.
Solution Approach 2:
The device combines shape memory alloy with endothelialized membrane materials to create a composite structure that provides both mechanical occlusion and biological compatibility. This composite approach reduces thrombus formation while maintaining reliable LAA closure.
3Reliability
If conventional LAA closure devices are used, then LAA occlusion can be achieved, but device stability decreases due to implant migration and fracture
Solution Approach 1:
The contact member is designed with a spherical or ellipsoidal geometry that conforms to the LAA anatomy, providing stable positioning and preventing migration. The curved shape distributes contact forces evenly, reducing stress concentrations that could lead to fracture, thereby maintaining long-term implant stability.
Solution Approach 2:
The device is designed as a single-use implant that is deployed and left in place, eliminating the need for retrieval or adjustment procedures that could compromise stability. The disposable nature ensures consistent performance without the risks associated with repeated manipulation.
4Reliability
If conventional LAA closure devices are used, then LAA occlusion can be achieved, but procedural time increases due to follow-up requirements
Solution Approach 1:
The device incorporates radiopaque markers and echogenic features that provide immediate feedback on deployment success and position, eliminating the need for extended follow-up procedures. The self-expanding mechanism provides visual confirmation of proper deployment, reducing procedural time and follow-up requirements.
Solution Approach 2:
The contact member is pre-formed with the final occlusion geometry before delivery, so that upon deployment, it immediately achieves the desired LAA closure without requiring additional shaping or adjustment steps. This preliminary preparation reduces procedural time and eliminates the need for follow-up interventions.
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 secure LAA occlusion with reduced thrombus risk, minimizing the need for prolonged anticoagulation and follow-up procedures, while enhancing procedural efficiency and safety.
Implementation Method 1
the contact member is configured to rotate at least in a first direction from a first rotational position to a second rotational position
Implementation Method 2
a self-expanding mechanism to securely twist and occlude the LAA
Data Source
AI summary
Disclosed are embodiments of a method for occluding a left atrial appendage (LAA) and other cavities or openings within a body. Some embodiments of the method can include an implant configured to be deployed within the LAA or other cavity, configured to be expanded or moved against a wall portion of the LAA or other cavity, and configured to twist at least a portion of the LAA or other cavity when the implant is rotated. Thereafter, one or more securing elements, staples, sutures, or other fasteners can be implanted in the gathered tissue to hold the tissue in the gathered state, thereby occluding the opening of the LAA or other cavity. In some embodiments, the opening of the LAA or other cavity can be occluded by elongating or otherwise reshaping the opening using an implant device, and securing the opening in the occluded state.