Conformable LAA Occlusion Device with Foam Sidewall
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Solution Overview
Problem
Existing devices for occluding the left atrial appendage (LAA) face challenges such as variable anatomy, difficulty in sizing, risk of tearing or residual leakage, and complications during delivery and anchoring.
Innovation Solution
A conformable LAA occlusion device featuring an expandable tubular body with a compressible open cell foam sidewall and a self-expandable support frame, which conforms to the oval shape of the LAA, provides superior sealing, and can be delivered off-axis without extensive pre-procedure imaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing LAA occlusion devices are used with variable sizing to match highly variable LAA anatomy, then sealing effectiveness may be improved, but device complexity and difficulty of procedure increase due to requiring multiple sizes and extensive pre-procedure imaging
Solution Approach 1:
The patent applies universality by designing a single standardized device size that can effectively treat the majority of LAA anatomies without requiring multiple sized devices. The compliant frame and foam body are designed to adapt to anatomical variations within a standard size range, eliminating the need for extensive customization and simplifying the procedural workflow while maintaining adequate sealing effectiveness.
Solution Approach 2:
The patent utilizes parameter changes by employing a compliant frame with specific mechanical properties that allow the device to deform and conform to the LAA ostium geometry. The foam body material parameters are selected to provide both structural support and adaptability, enabling the standardized device to achieve effective sealing across variable anatomies through elastic deformation rather than requiring multiple rigid size options.
2Strength
If existing LAA occlusion devices are made stiff to seal and anchor to surrounding tissue, then anchoring strength is improved, but risk of tissue damage and bleeding into pericardial space increases
Solution Approach 1:
The patent applies flexible shells by using a compliant frame constructed from elastic materials that can deform under physiological loads. This flexible structure provides sufficient anchoring strength through elastic recoil and tissue engagement while distributing contact pressures to prevent tissue damage and perforation, unlike rigid structures that concentrate stress at discrete points.
Solution Approach 2:
The patent employs composite materials by combining the compliant frame with a foam body that has different mechanical properties. The frame provides structural support and anchoring function with controlled compliance, while the foam body provides sealing and cushioning with higher compressibility. This composite structure achieves both strong anchoring and tissue protection through material property differentiation.
3Ease of manufacture
If existing LAA occlusion devices are designed with round geometry, then manufacturing is simplified, but sealing effectiveness decreases due to poor conformability with the oval LAA ostium
Solution Approach 1:
The patent applies dynamics by designing the frame with geometric characteristics that enable shape transformation during deployment. The frame structure allows transition from a compressed delivery configuration to an expanded configuration that conforms to the oval LAA ostium geometry. This dynamic adaptability enables the device to achieve superior sealing effectiveness while maintaining manufacturing simplicity through a single standardized design.
4Measurement precision
If existing LAA occlusion devices require coaxial positioning during delivery, then anchoring precision is improved, but delivery complexity increases due to requiring precise alignment and adjunctive imaging
Solution Approach 1:
The patent applies phase transitions by utilizing the frame's elastic deformation characteristics during delivery and deployment. The frame transitions from a flexible compressed state within the delivery catheter to an expanded rigid state after deployment, achieving stable positioning without requiring precise coaxial alignment during the delivery phase. This elastic phase transition enables simplified off-axis delivery while maintaining adequate anchoring precision.
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 device achieves effective sealing of the LAA ostium, reduces the risk of embolization, and simplifies the delivery procedure by accommodating anatomical variability and minimizing the need for extensive imaging.
Implementation Method 1
The expandable tubular body has a compressible open cell foam sidewall... the foam sidewall provides a cushion between the support and the wall of the left atrial appendage
Implementation Method 2
A conformable LAA occlusion device featuring an expandable tubular body with a compressible open cell foam sidewall and a self-expandable support frame
Data Source
AI summary
Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame having anchors and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. A loader includes a conical portion with guides and a reservoir for submerging the foam implant prior to loading and delivery.