Angled Jaw Closure Applicator for Left Atrial Appendage Sealing
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Solution Overview
Problem
Existing delivery tools for compliant tissue closure devices, such as those used for isolating the left atrial appendage, face challenges with proper alignment and orientation, particularly during less invasive procedures, leading to potential gaps or 'cul-de-sacs' that increase thrombus formation risks.
Innovation Solution
A closure device applicator with angled jaws and a dual-trigger mechanism that ensures proper alignment and sequential deployment of fasteners, providing audible confirmation and interlocks to prevent premature opening, facilitating complete closure and reducing the risk of procedure failure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If the delivery tool is introduced through an intercostal penetration to access the left atrium, then the invasiveness of the procedure is reduced, but the positioning and orientation of the delivery tool becomes difficult
Solution Approach 1:
The jaw assembly is designed with an angled configuration (10-20 degrees) relative to the shaft axis, creating an asymmetric geometry that facilitates proper alignment with the left atrial appendage base when introduced through intercostal penetration. This asymmetric angle compensates for the anatomical challenges of the approach route.
Solution Approach 2:
The jaw assembly operates in a plane that is angled relative to the shaft axis, adding a dimensional component to the delivery mechanism. This angular plane of operation allows the jaws to align properly with the tissue target while the shaft maintains a different orientation during introduction.
2Device complexity
If the jaws are attached in the axial plane of the device shaft, then the structural simplicity is maintained, but the alignment with the base of the appendage and across the os becomes difficult
Solution Approach 1:
The jaw assembly is deliberately designed with an angled attachment (10-20 degrees) relative to the shaft axis rather than being axially aligned. This asymmetric configuration enables the jaws to align with the base of the left atrial appendage and completely close the os, preventing gaps or cul-de-sacs while maintaining reasonable structural simplicity.
3Ease of operation
If the actuation of the jaws and retraction of the comb studs is performed without strict sequencing, then the ease of operation is improved, but the risk of delivery failure increases
Solution Approach 1:
The linkage assembly is designed so that jaw closure and stud retraction are coupled through a mechanical sequence. The triggers are arranged to first close the jaws (deploying fasteners) and then retract the studs, ensuring proper sequencing is performed automatically rather than requiring manual coordination.
Solution Approach 2:
An audible confirmation mechanism provides feedback to the operator when the jaws are fully closed and locked. This feedback ensures the operator knows the correct sequence has been achieved and prevents premature opening of the jaws before stud retraction is complete.
4Ease of operation
If the jaws are not properly aligned across the base to completely close the os, then the ease of operation is improved, but gaps or openings remain that increase the risk of thrombus formation
Solution Approach 1:
The angled jaw assembly (10-20 degrees) is specifically designed to align with the anatomy of the left atrial appendage base, enabling complete closure of the os without gaps or cul-de-sacs. This asymmetric angle ensures proper positioning that eliminates thrombus formation risks.
Solution Approach 2:
The mechanical design of the angled jaw assembly inherently guides proper alignment through its geometry, replacing the need for complex manual alignment procedures. The angular configuration mechanically ensures the jaws close completely across the os.
Data Source
AI summary
Devices, systems, and methods for closing the base of a left atrial appendage or other tissue structure comprise a device applicator having jaws, a shaft, and a handle. First and second triggers on a handle are configured to close the jaws and a closure device in a step-wise manner where tissue penetrating fasteners within the closure device are engaged by studs on the jaws, where the studs must be released prior to the opening of the jaws.