Single-Layer PET Braided Sealing Members for Implantable Devices
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Solution Overview
Problem
Conventional sealing members for implantable prosthetic devices face challenges in manufacturing complexity, increased production costs, and potential failure due to the difficulty in aligning and suturing multiple layers, which affect the sealing performance and integrity.
Innovation Solution
The use of a single-layer cylindrical braided material composed of multifilament polyethylene terephthalate (PET) strands braided with monofilament PET strands, providing structural integrity, resiliency, and softness, which can transition from a compressed to an expanded configuration to securely engage with native tissue and limit fluid flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sealing members use multiple layers for construction, then sealing performance may be improved, but manufacturing complexity and production costs increase
Solution Approach 1:
The patent merges multiple functional layers into a single integrated braided structure. The sealing member comprises a single layer of braided material that simultaneously provides structural support, sealing surfaces, and flexibility, eliminating the need for separate layers that would require alignment and suturing operations.
Solution Approach 2:
The sealing member uses a composite braided structure combining multifilament strands with monofilament strands. This composite construction provides both structural integrity from the monofilament components and flexibility/sealing capability from the multifilament components, achieving multiple functions in one material system.
2Reliability
If conventional sealing members use multiple layers, then sealing performance may improve, but production costs increase
Solution Approach 1:
By combining multiple layers into a single braided construction, the patent reduces manufacturing steps, eliminates the need for precise alignment operations, and removes the requirement for suturing multiple layers together, thereby reducing production costs while maintaining sealing performance.
3Reliability
If conventional sealing members use multiple layers, then sealing performance may improve, but alignment and suturing difficulty increase
Solution Approach 1:
The single-layer braided structure eliminates the alignment and suturing operations required for multi-layer constructions. The integrated design provides sealing surfaces and structural support in one continuous material, removing the operational complexity of aligning multiple layers and performing suturing procedures.
4Ease of operation
If the sealing member transitions from compressed to expanded configuration, then engagement with native tissue improves, but structural integrity may be compromised
Solution Approach 1:
The sealing member is designed with dynamic characteristics that allow it to transition from a compressed delivery configuration to an expanded engagement configuration. The braided structure provides elastic recovery, enabling the material to maintain structural integrity while adapting its shape to engage with native tissue effectively.
Solution Approach 2:
The composite braided structure combines materials with appropriate elastic properties that allow deformation during delivery but maintain strength during engagement. The monofilament and multifilament components work together to provide both the flexibility needed for compression and the structural integrity needed for expanded deployment.
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 single-layer braided material simplifies construction, reduces production costs, and enhances sealing performance by ensuring a secure fit and reduced paravalvular leakage, while maintaining structural integrity and softness.
Implementation Method 1
the monofilament strands can provide structural stability and/or resiliency to the sealing member
Implementation Method 2
the multifilament strands can provide bulk, softness, and/or coverage to the sealing member
Data Source
AI summary
Sealing members for use with implantable devices and associated methods are disclosed. The sealing members include monofilament strands braided with multifilament strands into a cylindrical braided material. The monofilament strands and the multifilament strands can each comprise polyethylene terephthalate (PET). The monofilament strands can provide structural integrity and resiliency to the cylindrical braided material. The monofilament strands can provide bulk, coverage, and softness to the cylindrical braided material. A method for creating the cylindrical braided material can include a first heat setting step on a straight mandrel at a lower temperature and a second heat setting step at a higher temperature on a shaped mandrel. The sealing members made from the cylindrical braided materials can function to anchor or engage an implantable device to surrounding tissue and limit or prevent paravalvular leakage or other fluid flow around the implantable device when implanted.