Implantable LAA Occlusion Device with Retractable Energy Delivery
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Solution Overview
Problem
Existing devices for occluding the left atrial appendage (LAA) are limited by issues such as residual stumps, leaks, requirement for blood thinners due to foreign materials, and inability to prevent atrial fibrillation and thrombotic events, especially in irregularly shaped openings, with connectors exposed to circulating blood causing device-related thrombus formation.
Innovation Solution
A device comprising a radially expansible element with a detachable energy delivery and sensor system, allowing transluminal delivery, deployment, and independent retraction, which occludes the LAA by heating tissue for electrical isolation and devascularization, with a design that separates the connector from circulating blood to prevent thrombus formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a connector is exposed to circulating blood to enable device delivery and operation, then the device can be delivered and function properly, but device-related thrombus formation occurs
Solution Approach 1:
The connector is extracted from the blood-exposed environment by positioning it on the proximal side of the occlusion device, separated from circulating blood by the occluding element. This allows the connector to remain functional for device operation while eliminating its exposure to blood that would cause thrombus formation.
2Reliability
If existing occlusion devices are used to block the LAA opening, then occlusion is achieved, but residual stumps and leaks remain
Solution Approach 1:
The occlusion device utilizes shape memory alloy material that changes its physical parameters (shape and size) in response to temperature changes. The device is delivered in a compressed state, then expanded in situ to achieve complete occlusion of the LAA opening, adapting to the irregular anatomy without leaving residual stumps or leaks.
3Reliability
If foreign materials are used to occlude the LAA, then occlusion is achieved, but blood thinners are required due to thrombus risk
Solution Approach 1:
The device employs shape memory alloy that undergoes phase transformation from austenite to martensite structure with temperature changes, enabling the occluding element to expand and conform to the LAA anatomy. This creates a stable occlusion that reduces thrombus risk compared to traditional foreign materials.
4Reliability
If the occlusion device is made to fit irregularly shaped LAA openings, then complete occlusion is achieved, but device complexity increases
Solution Approach 1:
The occlusion device is segmented into multiple expandable elements or struts that can independently adjust to conform to irregular LAA geometries. This segmentation allows the device to adapt to various shapes while maintaining a relatively simple overall structure that can be delivered through standard catheters.
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
Effectively occludes the LAA, preventing thrombotic events and atrial fibrillation by ensuring complete occlusion and electrical isolation, while minimizing thrombus risk through a design that keeps the connector out of circulating blood.
Implementation Method 1
an energy delivery element configured to deliver energy to surrounding tissue to heat the tissue
Data Source
AI summary
A device for occlusion of a body lumen comprises an implantable occlusion apparatus (3) operably attached to an elongated catheter member (4) configured for transluminal delivery and deployment of the occlusion apparatus in the body lumen. The occlusion apparatus comprises a radially expansible element (5) detachably attached to the elongated catheter member, and adjustable between a contracted orientation suitable for 10 transluminal delivery and a deployed orientation configured to occlude the body lumen, an energy delivery element (6, 14, 21) configured to deliver energy to surrounding tissue to heat the tissue, and a sensor (7) configured to detect a parameter of the wall of the body lumen. The energy delivery element (6, 14, 21) and sensor (7) are axially movable independently of the radially expansible element whereby, in use, the energy delivery 15 element and sensor can be transluminally retracted leaving the radially expansible element in-situ occluding the body lumen.