Left Atrial Appendage Closure by Rotational Tissue Twisting
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Solution Overview
Problem
Conventional LAA closure devices face issues such as complicated sizing algorithms, implant migration, leakage, fracture, and thrombus formation, necessitating prolonged anticoagulation and follow-up procedures, with a 7.2% annual incidence of device-related thrombus.
Innovation Solution
A device 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 anchor within the LAA, ensuring effective closure and minimizing thrombus risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional LAA closure devices are used, then LAA closure is achieved, but device migration, leakage, and fracture occur
Solution Approach 1:
The device is divided into distinct functional segments: a delivery catheter for minimally invasive insertion, an expandable frame that transitions from a compressed to expanded state for secure anchoring, and a closure element that seals the LAA. This segmentation allows each component to be optimized independently for its specific function while maintaining overall device reliability.
Solution Approach 2:
The device employs dynamic transitions from a compressed delivery state to an expanded deployed state. The expandable frame dynamically adjusts its configuration to engage with the LAA anatomy, providing secure anchoring that prevents migration while accommodating physiological movements. This dynamic design enhances reliability without requiring overly complex static structures.
2Reliability
If conventional LAA closure devices are used, then LAA closure is achieved, but thrombus formation occurs with 7.2% annual incidence
Solution Approach 1:
The closure element utilizes a flexible membrane or thin film structure that conformally seals the LAA ostium. This flexible barrier effectively prevents thrombus formation by eliminating blood flow turbulence and stasis at the closure site, achieving thrombus prevention with a relatively simple structural design rather than complex mechanical systems.
3Reliability
If conventional LAA closure devices are used, then LAA closure is achieved, but prolonged anticoagulation and follow-up procedures are required
Solution Approach 1:
The device incorporates self-anchoring features through its expandable frame design that automatically engages with the LAA anatomy upon deployment. This self-service mechanism eliminates the need for prolonged anticoagulation therapy and extensive follow-up procedures, as the device secures itself without requiring additional interventions or monitoring over extended periods.
4Manufacturing precision
If conventional LAA closure devices are used, then LAA closure is achieved, but device sizing is complicated
Solution Approach 1:
The device employs a family of pre-fabricated sizes with standardized dimensions that simplify the sizing selection process. The expandable frame design allows the same base structure to accommodate varying LAA anatomies through controlled expansion, reducing the need for complex sizing algorithms while maintaining manufacturing precision for each size variant.
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 provides secure LAA closure with reduced thrombus risk, eliminating the need for prolonged anticoagulation and follow-up procedures, and significantly lowers the incidence of device-related thrombus.
Implementation Method 1
a contact member that rotates and engages the LAA wall
Implementation Method 2
a self-expanding mechanism to securely anchor within the LAA
Data Source
AI summary
Disclosed are embodiments of a device for occluding a left atrial appendage (LAA) and other cavities or openings within a body. Some embodiments of the device 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.


