Flexible Occlusion Device for Left Atrial Appendage
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Solution Overview
Problem
Current methods for occluding the left atrial appendage to prevent blood clot formation and migration are associated with risks such as pericardial effusion, incomplete closure, dislodgment of devices, and the need for prolonged anticoagulation, and are not suitable for all patients due to invasiveness and complications.
Innovation Solution
A delivery instrument with a distal end portion and a single strand of flexible occlusion material, such as nitinol wire, that forms an arbitrarily intermingled array within the left atrial appendage, securely closing the entrance and preventing clot exit, with a radially expandable cover structure to ensure effective occlusion without attachment to the appendage tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid occlusion device is used to ensure complete closure of the left atrial appendage, then the reliability of occlusion is improved, but the device complexity and risk of dislodgment increase
Solution Approach 1:
The patent employs a flexible occlusion device comprising a fabric body with integrated sealing elements that can conform to the irregular geometry of the left atrial appendage. The flexible fabric construction allows the device to adapt to patient-specific anatomy while maintaining reliable occlusion, eliminating the need for complex rigid structures with multiple attachment points and adjustment mechanisms.
2Device complexity
If a one-size-fits-all occlusion device is used, then the device complexity is reduced, but the adaptability to different appendage sizes and configurations deteriorates
Solution Approach 1:
The patent utilizes fabric materials with variable mechanical properties including stretchability, compliance, and shape-memory characteristics. These parameter changes allow a single device design to adapt to different appendage sizes and configurations. The fabric can be delivered in a compressed state through standard catheters and then expand to conform to the specific geometry of each patient's left atrial appendage.
3Ease of operation
If traditional anticoagulation therapy is used to prevent clot formation, then the ease of operation is improved, but the object-generated harmful factors increase due to treatment contraindications and side effects
Solution Approach 1:
The patent extracts the clot prevention function from the bloodstream and relocates it to the occlusion device itself. By completely isolating the left atrial appendage where clots form, the device eliminates the need for systemic anticoagulation therapy. This extraction approach removes the harmful side effects of anticoagulants while maintaining the protective function against thromboembolism.
4Reliability
If an invasive surgical procedure is used to ensure complete occlusion, then the reliability of closure is improved, but the ease of operation and patient eligibility deteriorate
Solution Approach 1:
The patent replaces the mechanical surgical approach with a minimally invasive percutaneous delivery system. The fabric occlusion device is introduced through a catheter accessed via the venous system, eliminating the need for sternotomy, cardiopulmonary bypass, and direct surgical manipulation of the left atrial appendage. This substitution maintains reliable occlusion while dramatically reducing procedural invasiveness and expanding patient eligibility.
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 solution provides a safe and effective occlusion of the left atrial appendage, reducing the risk of blood clot migration and stroke, while being adaptable to different appendage sizes and configurations, and avoiding the limitations of existing occlusion devices.
Implementation Method 1
at least one elongated single strand of flexible material having sufficient flexibility to progressively form an arbitrarily intermingled array of occlusion material within the interior of the left atrial appendage as it is progressively fed therein in a manner which substantially fills and conforms to the interior configuration
Data Source
AI summary
An assembly and method for performing the occlusion of the left atrial appendage including a delivery instrument being positioned in communicating relation with the interior of the left atrial appendage and disposing a distal end portion of the delivery instrument in covering relation to the entrance thereof. Occlusion material is movably connected to the delivery instrument and includes at least one elongated single strand of flexible material. A length of the single strand is progressively fed through the delivery instrument into the interior of the left atrial appendage and the flexibility thereof is sufficient to progressively form an arbitrarily intermingled array of occlusion material therein. The dimension and configuration of the formed arbitrarily intermingled array is sufficient to fill a predetermined portion of the interior of the left atrial appendage and thereby conform to the configuration thereof.