Pledgeted Tissue Anchor Force Distribution

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Solution Overview

Problem

Existing tissue anchoring methods often result in high failure rates and bleeding due to the concentration of force at a single point, which can lead to tissue damage and complications during medical procedures like cardiac therapies.

Innovation Solution

A minimally invasive anchoring system comprising multiple anchoring devices with attachment mechanisms such as barbs, magnets, and pledgets that spread the force across multiple points on the tissue wall, reducing stress and preventing bleeding by using a suture that passes through the tissue wall at multiple points and a plugging device to cover holes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a single-point tissue anchor is used, then the device complexity is reduced, but the reliability decreases due to high failure rates and bleeding

Engineering Contradiction:
Improveanchoring reliabilityVSAvoidanchoring system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The anchoring system is divided into multiple discrete anchoring devices (first anchoring device, second anchoring device, etc.) that can be independently inserted through separate holes in the tissue wall. Each anchoring device operates as an independent unit, distributing the anchoring function across multiple points rather than relying on a single point, thereby improving reliability without requiring a single complex device structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Multiple anchoring devices are combined and connected through attachment mechanisms (such as magnets, barbs, hooks, or ties) to form a unified anchoring system. This merging of multiple simple anchoring units creates a coordinated system that distributes force across multiple tissue anchor points, improving overall reliability while maintaining relatively simple individual components.

Inventive Principle:
Principle #5Merging (Combining)

2Object-affected harmful factors

If force is concentrated at a single point, then the anchoring device structure is simplified, but harmful effects increase due to tissue damage and bleeding

Engineering Contradiction:
Improvetissue damage and bleedingVSAvoidanchoring system structure
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The anchoring function is segmented across multiple discrete anchoring devices inserted at different locations through separate holes in the tissue wall. This segmentation distributes the mechanical force across multiple anchor points, preventing concentration of stress at a single point that would cause tissue damage and bleeding, while each individual anchor point remains structurally simple.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The anchoring system transitions from a single-point (0D) or linear (1D) anchoring approach to a distributed multi-point (2D or 3D) anchoring configuration. By arranging multiple anchoring devices at different spatial positions and orientations within the tissue wall, the system creates a volumetric distribution of anchor points that better disperses force and reduces localized tissue stress.

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

3Reliability

If multiple anchoring devices are used, then the reliability improves, but the device complexity increases

Engineering Contradiction:
Improveanchoring stabilityVSAvoidnumber of components
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The attachment mechanisms (magnets, barbs, hooks, ties) serve multiple functions: they connect different anchoring devices to each other, provide secure anchoring within the tissue wall, and enable force distribution across multiple points. This multi-functionality reduces the need for separate connection components and simplifies the overall system architecture despite using multiple anchoring devices.

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

Solution Approach 2:

The anchoring devices are designed with self-anchoring capabilities through features like barbs that embed in tissue, magnets that provide automatic attraction and connection, or hooks that latch onto attachment mechanisms. This self-service design reduces the need for complex external connection systems and simplifies the assembly of multiple anchoring devices while maintaining high reliability.

Inventive Principle:
Principle #25Self-service

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 system effectively reduces the risk of tissue damage and bleeding by distributing the force across a larger area, enhancing the stability of the anchor and minimizing the risk of complications during medical procedures.

Implementation Method 1

the plugging device is configured to at least partially cover the first hole

Methodology Applied
Scientific EffectPhysical occlusion:

Implementation Method 2

The first attachment mechanism may comprise at least one of a barb, a magnet, a hook, a lasso, a corkscrew, a peg, and a tie

Methodology Applied
Scientific EffectMechanical interlocking: Mechanical Fastener

Implementation Method 3

The first attachment mechanism may comprise at least one of a barb, a magnet, a hook, a lasso, a corkscrew, a peg, and a tie

Methodology Applied
Scientific EffectMagnetic attraction: Magnetism

Implementation Method 4

A minimally invasive anchoring system comprising multiple anchoring devices with attachment mechanisms such as barbs, magnets, and pledgets that spread the force across multiple points on the tissue wall

Methodology Applied
Scientific EffectForce distribution:

Data Source

PatentUS20240215972A1Pledgeted tissue anchor
Publication Date: 2024.07.04 EDWARDS LIFESCIENCES CORP
  • US20240215972A1 patent drawing
  • US20240215972A1 patent drawing
  • US20240215972A1 patent drawing

AI summary

An anchoring system comprises a first anchoring device comprising a first plug and a second anchoring device comprising a first anchor, wherein each of the first anchoring device and the second anchoring device is configured to enter a tissue wall at a proximal side of the tissue wall, the first plug is configured to exit the tissue wall at a first point of a distal side of the tissue wall, the first anchor is configured to exit the tissue wall at a second point of the distal side of the tissue wall and attach to the first plug outside of the distal side of the tissue wall at a first entry point of the first plug, and the first plug is configured to at least partially cover the second point of the distal side of the tissue wall.