Left Atrial Appendage Twist-Closure Implant for Migration and Leakage
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Solution Overview
Problem
Conventional left atrial appendage (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
A system comprising an implant and a catheter that allows for controlled rotation and axial movement within the LAA, featuring a contact member to twist and secure the appendage, and a securing element to prevent reverse rotation, along with tissue anchors to engage the heart tissue, facilitating secure closure without extensive post-procedural anticoagulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional LAA closure devices are used, then LAA closure can be achieved, but implant migration and leakage occur
Solution Approach 1:
The delivery system employs a dynamic staged deployment mechanism where the implant transitions from a compressed delivery state to an expanded deployed state. The outer sheath is retracted to allow the implant to expand, and the delivery catheter is withdrawn, enabling the implant to assume its final configuration anchored in the LAA. This dynamic transformation ensures proper positioning and stability while achieving effective closure.
Solution Approach 2:
The device is divided into distinct functional segments: the implant portion with anchors and occlusion element, the delivery catheter system, and the outer sheath. This segmentation allows each component to perform its specific function independently during deployment, ensuring controlled positioning and stable anchoring of the implant in the LAA while maintaining closure effectiveness.
2Reliability
If conventional LAA closure devices are used, then LAA closure can be achieved, but leakage around or through the implant occurs
Solution Approach 1:
The implant incorporates a flexible occlusion element that conforms to the irregular inner surface of the LAA. This flexible membrane creates a seal that adapts to the anatomical variations of the LAA cavity, preventing leakage around or through the implant while maintaining effective closure. The flexibility allows the occlusion element to conform tightly to the LAA walls.
3Reliability
If conventional LAA closure devices are used, then LAA closure can be achieved, but complicated pre-procedural sizing algorithms are required
Solution Approach 1:
The delivery system incorporates self-sizing capabilities through the expandable implant design and imaging guidance integration. The implant automatically adapts to the LAA dimensions during deployment, and the system integrates imaging modalities to provide real-time feedback for sizing verification. This eliminates the need for complex pre-procedural sizing algorithms while ensuring effective closure.
4Reliability
If conventional LAA closure devices are used, then LAA closure can be achieved, but device fracture occurs
Solution Approach 1:
The implant is constructed using composite materials that combine the strength of metal anchors with the flexibility of biocompatible polymers. The anchor portions provide structural integrity and resistance to fracture, while the occlusion element uses flexible material that can withstand physiological stresses. This composite construction maintains device structural integrity while achieving effective LAA closure.
Data Source
AI summary
A system for treating a left atrial appendage includes a delivery catheter and an implant having a contact member configured to engage an inside tissue surface of the left atrial appendage and to rotate in at least a first direction from a first position to at least a second position so as to twist the left atrial appendage when the contact member is engaged with an inside tissue surface of the left atrial appendage. Some arrangements of the system include a support stand for supporting the delivery catheter during a procedure. Some arrangements of the implant include a securing element configured to engage the tissue of the left atrial appendage that has twisted.