Implantable Device Protrusions for Sealing Irregular Cavities
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Solution Overview
Problem
Existing LAA occluder devices face challenges in achieving proper sealing due to mismatched shapes between the device and the LAA cavity, leading to residual leakage and increased risk of embolization.
Innovation Solution
The development of an implantable device with protrusions that can independently unfold into gaps between the device and the LAA wall, supported by a biocompatible covering material to enhance sealing and anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the device is significantly oversized to ensure adequate sealing, then sealing effectiveness is improved, but the LAA ostium may become overstretched leading to tearing and bleeding into the pericardial space
Solution Approach 1:
The device is divided into a main body and separate protrusions that can independently deploy. The protrusions are initially compressed against the main body during delivery, then independently unfold to fill gaps between the device and LAA wall, providing enhanced sealing without requiring the entire device to be oversized
Solution Approach 2:
The protrusions provide localized sealing enhancement at specific gaps between the device and LAA wall. Instead of uniformly increasing device size, the sealing capability is concentrated where needed through the independently deployable protrusions with biocompatible covering material
2Object-affected harmful factors
If the device is too small to match the highly variable LAA anatomy, then tissue damage is reduced, but the device will not adequately seal the LAA ostium and may be prone to embolization
Solution Approach 1:
The protrusions are designed to be dynamically deployable rather than statically fixed. They can be compressed during delivery to navigate the catheter, then independently unfold at the implantation site to adapt to the specific LAA geometry, providing both safety and sealing effectiveness
Solution Approach 2:
The device configuration changes from a compressed state during delivery to an expanded state with protrusions at implantation. The protrusions can change their deployment state independently to match the variable LAA anatomy, transitioning between compact and extended configurations
3Stability of the object's composition
If the device forces the oval LAA ostium to take the round shape of the device, then device stability is improved, but residual leakage occurs at the edges due to poor sealing
Solution Approach 1:
The protrusions are strategically positioned asymmetrically around the device circumference to target specific gaps between the round device and the oval LAA ostium. This asymmetric deployment allows the device to maintain its stable round shape while filling in the asymmetric gaps that cause leakage
4Reliability
If sufficient spring force or stiffness is used to seal and anchor the device, then sealing and anchoring are improved, but blood may leak through the tissue into the pericardial space
Solution Approach 1:
The anchoring function is segmented between the main device body and the protrusions. The main body provides primary anchoring with controlled spring force, while the protrusions provide additional anchoring and sealing at the periphery, distributing the mechanical load and reducing the risk of tissue perforation
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 achieves improved sealing and anchoring of the implantable device, reducing the risk of residual leakage and embolization, and providing better adaptability to irregularly shaped spaces.
Implementation Method 1
one or more protrusions with independent motion, so they can unfold into the gaps between the implantable device and the LAA wall
Implementation Method 2
The protrusions can be covered with a biocompatible material to improve the sealing
Data Source
AI summary
The present invention relates to an implantable device comprising a skeleton, and an attached covering material to enable better sealing and/or anchoring to address the issue of mismatch between the shape of the implantable device when fully extended and an opening of any kind it is made to occlude. Alternatively, the implantable device as disclosed can be used to generate a prosthetic valve. The present invention utilizes one or more protrusions/extensions with or without additional attached or linked covering material, and the protrusions and covering material when combined with an attachment ring can form a unit called a Sealing Halo unit. Any combination of protrusions and the covering material can extend into any gap on the outside of the periphery of the implantable device. The implantable device can generate various types of implantable medical devices including Left Atrial Appendage (LAA) occluders, Transcatheter Aortic Valve Replacement (TAVR), Transcutaneous Mitral Valve Replacement, Atrial Septal Occluders, Patent Foramen Ovale occluders, Vascular Plugs, etc. In addition, the disclosed implantable device can also generate non-medical devices to occlude any kind of non-medical openings.