LAA Exclusion Clip Cover Assembly for Low-Profile Occlusion
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Solution Overview
Problem
Existing LAA occlusion devices are often large, obstructing the surgeon's view and difficult to use in minimally invasive surgical approaches, and there is a need for improved construction and operation of occlusion devices to enhance their effectiveness and usability.
Innovation Solution
The development of an exclusion device for anatomical structures, comprising a first beam, a second beam, and at least one spring operatively coupled to both beams to exert a closing force, with crimp connections and spring stress reduction features to enhance functionality and ease of use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If larger LAA occlusion clips are used to ensure secure occlusion, then occlusion effectiveness is improved, but device profile increases causing obstruction of surgeon's view and difficulty in minimally invasive approaches
Solution Approach 1:
The exclusion device is designed to be nestable within itself or within a delivery catheter, allowing the device to be collapsed into a compact configuration for minimally invasive delivery while expanding to a larger functional size for effective occlusion. This nesting capability resolves the contradiction by enabling the device to have a small delivery profile while maintaining adequate occlusion dimensions when deployed.
Solution Approach 2:
The device incorporates dynamic elements such as flexible beams and springs that allow it to transition between compressed and expanded states. The flexible construction enables the device to adapt its profile dynamically - compact during delivery and insertion, then expanded to provide secure occlusion, thus resolving the size contradiction.
2Reliability
If larger LAA occlusion clips are used to ensure secure occlusion, then occlusion effectiveness is improved, but ease of operation deteriorates due to obstruction of surgeon's view
Solution Approach 1:
The device's ability to nest within a delivery system allows it to remain compact during the critical phases of delivery and positioning, minimizing obstruction of the surgeon's view. Once positioned, the device expands to provide effective occlusion, thus resolving the contradiction between visibility and occlusion effectiveness.
Solution Approach 2:
The exclusion device is divided into modular components (beams, springs, connectors) that can be independently manipulated and positioned. This segmentation allows the surgeon to control and position the device more precisely with better visibility, while the assembled device provides adequate occlusion effectiveness.
3Ease of operation
If smaller profile exclusion devices are used to improve ease of operation and minimize obstruction, then ease of operation is improved, but occlusion effectiveness may deteriorate
Solution Approach 1:
The device uses dynamic spring mechanisms and flexible beams that enable it to transition from a compact delivery profile to an expanded occlusion configuration. This dynamic transformation ensures the device is easy to deliver via minimally invasive approaches while maintaining adequate occlusion effectiveness when deployed.
Solution Approach 2:
The device changes its physical parameters (size, shape, stiffness) between delivery and functional states. During delivery, it maintains a small profile for ease of operation, then undergoes parameter changes upon deployment to achieve the necessary size and rigidity for effective occlusion, resolving the contradiction.
4Adaptability or versatility
If more complex spring connections are used to improve device functionality, then device functionality is improved, but device complexity increases
Solution Approach 1:
The spring connection system is segmented into modular units that can be independently manufactured and assembled. This segmentation allows for improved functionality through modular design while keeping individual components simple, thus resolving the contradiction between functionality and overall device complexity.
Solution Approach 2:
The spring connectors are designed to perform multiple functions: providing mechanical connection, enabling controlled movement, and facilitating force distribution. This multi-functionality reduces the need for additional separate components, improving device functionality while minimizing the increase in overall complexity.
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 proposed solution allows for a smaller profile exclusion device that minimizes obstruction during surgical procedures, is suitable for minimally invasive approaches, and provides improved operational efficiency and effectiveness in occluding anatomical structures.
Implementation Method 1
at least one spring operatively coupled to the first beam and the second beam to exert a closing force on the first beam and the second beam and bias the first beam and the second beam in a closing direction
Implementation Method 2
The first crimp connection may include a plastically deformed portion of the at least one spring engaged with a plastically deformed portion of the first beam
Data Source
AI summary
Exclusion devices for anatomical structures, and related instruments and related methods, are disclosed. An exemplary method of making an exclusion device for an anatomical structure may comprise assembling a clamping portion of an exclusion device comprising a beam and a biocompatible fabric cover, and securing the cover on the beam by ultrasonic welding a first portion of the cover to a second portion of the cover.