Tissue Ligation Device with Adaptive Suture Loop
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Solution Overview
Problem
Current methods for closing the left atrial appendage, such as suturing or stapling, are invasive, carry risks, and may lead to leaks due to tissue remodeling, necessitating the development of minimally invasive or less invasive techniques for effective thrombus prevention in atrial fibrillation patients.
Innovation Solution
The development of tissue closure devices featuring an elongate body with a snare and tightening element, including a suture or snare loop, and a force generator like compression springs or expandable polymers, which can maintain closure force even as tissue size changes, using one-way mechanisms to ensure secure ligation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgery with suturing is used to close the left atrial appendage, then effective thrombus prevention is achieved, but the procedure carries high risk and is only available to patients undergoing open-heart surgery
Solution Approach 1:
The patent replaces the mechanical suturing system (needles, threads, sutures) with a controlled delivery system that uses radial expansion forces. The collapsible structure is delivered in a compressed state through a catheter and expanded at the target site, eliminating the need for open-heart surgery and general anesthesia while achieving effective appendage closure
Solution Approach 2:
The patent introduces a catheter-based delivery system as an intermediary between the operator and the closure device. The catheter allows minimally invasive access to the left atrial appendage through vascular routes, avoiding the need for chest opening and direct surgical manipulation of the appendage
2Reliability
If suturing is performed to close the left atrial appendage, then blood flow into the appendage is cut-off, but tissue remodeling and shrinking can cause leaks over time
Solution Approach 1:
The patent employs a dynamic closure system where the collapsible structure can adapt to tissue remodeling. The structure includes features that allow it to maintain sealing contact with the appendage wall even as the tissue shrinks or changes shape over time, preventing leaks that would occur with rigid sutures
Solution Approach 2:
The patent applies preliminary compression and sealing forces during the closure process to ensure immediate and effective sealing of the appendage ostium. The controlled expansion of the collapsible structure creates initial high-contact-pressure sealing that prevents thrombus formation from the outset
3Ease of operation
If stapling or occlusion devices are used to close the left atrial appendage, then minimally invasive procedures are enabled, but stapling may cause tissue rupture and occlusion devices may not effectively prevent all blood flow
Solution Approach 1:
The patent changes the physical parameters of the closure device from rigid (staples, rigid occluders) to collapsible and compliant. The structure can be compressed to a small profile for delivery, then expanded to achieve closure with controlled radial forces that adapt to the soft tissue, avoiding both stapling-induced rupture and incomplete occlusion
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
These devices enable secure, minimally invasive closure of the left atrial appendage, reducing the risk of leaks and thrombus formation, while being adaptable to tissue remodeling, thus providing a safer and more effective alternative to traditional methods.
Implementation Method 1
The force generator may comprise a compression spring
Implementation Method 2
the force generator may comprise an expandable polymer
Implementation Method 3
the force generator may comprise a shape memory alloy
Implementation Method 4
the force generator may comprise a bladder. In some embodiments, the bladder may be at least partially filled with a liquid
Data Source
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AI summary
Described herein are tissue closure devices and methods for ligating a target tissue, such as the left atrial appendage. The tissue closure device may have an elongate body, a snare at least partially housed within the elongate body, a suture at least partially housed within the elongate body, and a tightening element coupled to the suture. The suture may have a suture loop, and the tightening element may be configured to decrease the size of the suture loop when the area of a tissue within the suture loop decreases.