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

VSEngineering 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

Engineering Contradiction:
Improveocclusion effectivenessVSAvoidleakage
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

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

Engineering Contradiction:
Improveocclusion effectivenessVSAvoidinvasiveness
Core Design Contradiction:
ReliabilityVSEase of operation

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.

Inventive Principle:
Principle #7Nested doll (Nesting)

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.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Engineering Contradiction:
ImproveleakageVSAvoidfastener structure
Core Design Contradiction:
Object-generated harmful factorsVSDevice complexity

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.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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.

Inventive Principle:
Principle #5Merging (Combining)

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

Engineering Contradiction:
Improveminimally invasiveVSAvoiddeployment coordination
Core Design Contradiction:
Ease of operationVSManufacturing precision

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.

Inventive Principle:
Principle #24Intermediary (Mediator)

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.

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS11622773B2Apparatus for fastening tissue and occluding tubular body structures
Publication Date: 2023.04.11 AMSEL MEDICAL CORP
  • US11622773B2 patent drawing
  • US11622773B2 patent drawing
  • US11622773B2 patent drawing

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.