Two-part Tissue Fastener with Interdigitated Legs for Vessel Occlusion
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Solution Overview
Problem
Current methods for occluding blood vessels and clamping tissue layers are often invasive, require significant post-operative care, and suffer from leakage issues due to the use of staples or sutures.
Innovation Solution
A minimally invasive two-part tissue fastener with interdigitated legs that expand radially to clamp tissue layers, minimizing leakage by constraining them in a serpentine pattern, and secured with a flexible retention member that locks the implants together, allowing for easy deployment through a needle and low-profile configuration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional staples or sutures are used to occlude blood vessels and clamp tissue layers, then the occlusion can be achieved, but significant leakage occurs and significant post-operative care is required
Solution Approach 1:
The fastener is divided into two separate cooperative parts (proximal and distal components) that are deployed independently through a single needle puncture. Each part includes multiple legs that interdigitate with the other part, creating multiple sealing points that prevent leakage while maintaining reliable occlusion.
Solution Approach 2:
The legs of the fastener parts are configured to extend radially outward from the longitudinal axis, creating a three-dimensional interdigitated structure. This radial expansion allows the legs to engage tissue from multiple directions, forming a serpentine pattern that effectively seals the puncture site and prevents leakage.
2Reliability
If traditional surgical methods are used to occlude blood vessels, then reliable occlusion is achieved, but the procedures require invasive surgery and significant post-operative care
Solution Approach 1:
Both parts of the fastener are nested within a single delivery needle during deployment. The needle serves as a common delivery pathway, allowing both proximal and distal components to be inserted through a single puncture site, thereby minimizing invasiveness while maintaining reliable occlusion.
Solution Approach 2:
A retention member with protrusions acts as an intermediary mechanism to draw the two separated fastener parts together after deployment. The retention member engages with detents on both parts, allowing them to be pulled into alignment and locked together, achieving reliable occlusion through a minimally invasive single-puncture approach.
3Object-generated harmful factors
If a two-part fastener with interdigitated legs is used to occlude vessels, then leakage is minimized, but the device complexity increases
Solution Approach 1:
The interdigitated leg structure serves multiple functions simultaneously: it provides mechanical interlocking between the two fastener parts, creates a serpentine sealing pattern to prevent leakage, and allows for radial expansion to engage tissue effectively. This multi-functionality reduces the need for additional separate components.
Solution Approach 2:
The fastener design merges the functions of two separate occlusion devices into a single integrated system. The proximal and distal parts, when combined through the interdigitated leg structure, work together as one unified fastening mechanism, simplifying the overall device architecture while minimizing leakage.
4Ease of operation
If a single needle puncture is used to deploy both fastener parts, then the procedure is minimally invasive, but the fastener parts must be precisely coordinated
Solution Approach 1:
The retention member with protrusions serves as a precision coordination mechanism. As the two fastener parts are drawn together through the needle, the protrusions on the retention member engage with detents on each part in a controlled sequence, ensuring precise alignment and coordination without requiring complex manual manipulation.
Solution Approach 2:
The fastener parts are designed with self-aligning features including the interdigitated leg structure and detent-protrusion engagement mechanism. Once deployed through the needle, the parts automatically align and lock together through their inherent geometric configuration, reducing the need for precise manual coordination during deployment.
Data Source
AI summary
Apparatus and methods for occluding hollow body structures, such as blood vessels, and for attaching tissue layers together by providing implantable elements on opposite sides of the structure or tissue layers and drawing the implants together to occlude the body structure and/or bring the tissue layers together. The implants are deliverable in a low-profile configuration and self-expand to an enlarged configuration. The implantable elements are delivered by transfixing the body structure, then releasing the implants on opposite sides of the body structure and drawing the implants together to effect an occlusion or attachment. The implants are configured to apply oppositely directed forces to opposite surfaces of the tissue layers at alternate, circumferentially spaced locations and may constrain the tissue in a serpentine pattern or in a direct clamping pattern. The implants grip the tissue in a manner that defines a pressure zone about the transfixion aperture that prevents leakage from the aperture. The implants have a low profile in that they have a relatively short axial dimension relative to their deployed diameter.


