Expandable LAA Gap Cover for Non-Circular Occluder Sealing
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Solution Overview
Problem
Therapeutic implants, such as occlusion devices, often experience leakage due to gaps between their circular shape and the non-circular anatomy of the heart, leading to reduced performance and potential blood clot formation.
Innovation Solution
An expandable implantable device is deployed via a catheter, expanding to cover non-circular gaps and secured to the therapeutic device using a fastener, ensuring complete sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a circular therapeutic implant is deployed, then the implant structure is simple and easy to manufacture, but gaps form between the circular implant and non-circular heart anatomy causing blood leakage
Solution Approach 1:
The implant transitions from a fixed circular shape to a dynamically adjustable shape that can expand and change configuration. The expandable structure allows the implant to adapt its geometry to match the non-circular heart anatomy, eliminating gaps while maintaining manufacturing simplicity through a standardized expandable framework.
Solution Approach 2:
The implant utilizes changeable physical parameters including expandability and shape adaptability. By controlling expansion parameters and geometric configuration, the implant can transform from a compact delivery state to an expanded sealing state that conforms to the heart anatomy, resolving the contradiction between simple manufacturing and effective sealing.
2Device complexity
If discrete sized implants are used, then inventory and manufacturing are simplified, but the implant may not fully expand to match the patient's specific anatomy creating gaps
Solution Approach 1:
The implant employs dynamic expansion capability that allows a single standardized implant size to adapt to multiple patient anatomies. The expandable structure enables the implant to grow to the required size during deployment, eliminating the need for multiple discrete sized implants while maintaining sealing effectiveness.
Solution Approach 2:
The expandable implant design creates a universal device that can serve multiple patient anatomies and gap configurations. A single implant model can accommodate various heart anatomy sizes and shapes through expansion, replacing the need for multiple specialized implant sizes and improving sealing performance across different patients.
3Device complexity
If circular plugs are used to fill gaps, then the plug structure is simple, but the non-circular gaps cannot be sufficiently plugged to prevent blood flow
Solution Approach 1:
The gap-filling device transitions from a simple static plug to a dynamic expandable structure. The expandable design allows the device to grow and conform to the specific shape and size of the gap, whether circular or non-circular, ensuring complete coverage while maintaining structural simplicity through a standardized expandable framework.
Solution Approach 2:
The device can assume asymmetric configurations to match non-circular gap shapes. By allowing the expandable structure to adopt asymmetric geometries, the device can perfectly contour to irregular heart anatomy and gap shapes, achieving complete sealing without requiring complex pre-formed asymmetric plugs.
Data Source
AI summary
Devices, systems, and methods for preventing leakage through a therapeutic implant are provided. In an exemplary aspect, an apparatus is provided. The apparatus includes an implantable device configured to: contact heart tissue proximate to a left atrial appendage (LAA) with an occlusion device, cover a non-circular gap between the occlusion device and a wall of the LAA, and prevent blood flow into or out of the LAA. The implantable device includes a frame forming an umbrella-like shape having a bottom and sides curving upwards from the bottom, a mesh disposed over the bottom and at least a portion of the sides of the frame, and a fastener extending downward from the bottom of the frame and configured to attach to the occlusion device.