Expandable Medical Device Anchor Barb Deployment

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Solution Overview

Problem

Balloon expandable medical devices face challenges in anchoring to the surrounding anatomy due to the need for aggressive over-expansion, which can damage tissues or result in poor anchoring if over-expansion is minimal, leading to potential dislodgement.

Innovation Solution

The use of expandable anchors or barbs that are contained within the compacted profile of the medical device, which extend outside the expanded profile to provide anchoring without excessive over-expansion, improving retention and minimizing tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If aggressive over-expansion is used to achieve anchoring, then anchoring strength is improved, but tissue damage occurs

Engineering Contradiction:
Improveanchoring strengthVSAvoidtissue damage
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The device is segmented into a balloon expandable component and separate expandable anchors/barbs. The anchors are initially contained within the compressed profile of the device and are deployed separately through balloon expansion, allowing anchoring function to be independent from the main device expansion, thus achieving strong anchoring without aggressive over-expansion of the entire device

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The anchors are pre-positioned within the compressed device profile during delivery, and the balloon expansion is used to preliminarily deploy them into the expanded profile configuration before final device deployment. This preliminary action ensures anchors are ready to engage the tissue immediately upon deployment, providing secure anchoring without requiring excessive expansion forces

Inventive Principle:
Principle #10Preliminary action

2Object-affected harmful factors

If minimal over-expansion is used to avoid tissue damage, then tissue damage is reduced, but anchoring strength deteriorates leading to device dislodgement

Engineering Contradiction:
Improvetissue damageVSAvoidanchoring strength
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The anchors transition from a static compressed state within the device profile to a dynamic expanded state that protrudes outward. This dynamic transformation is achieved through balloon expansion, allowing the anchors to adapt their configuration - remaining compact during delivery and then expanding to engage tissue securely, ensuring both minimal tissue damage during insertion and strong anchoring after deployment

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The physical parameters of the anchors change from a compressed configuration (contained within device profile) to an expanded configuration (protruding outside device profile). This parameter change in shape and volume is driven by balloon expansion, enabling the anchors to provide adequate engagement with surrounding tissue without requiring aggressive over-expansion of the entire device

Inventive Principle:
Principle #35Parameter changes

3Strength

If expandable anchors are added to improve anchoring, then anchoring strength is improved, but device complexity increases

Engineering Contradiction:
Improveanchoring strengthVSAvoiddevice complexity
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The expandable anchors are merged with the balloon expandable device into a single integrated system. The anchors are attached to the device and share the same balloon expansion mechanism, allowing them to be deployed simultaneously through a single expansion action. This merging provides improved anchoring without requiring separate deployment mechanisms, thus limiting the increase in device complexity

Inventive Principle:
Principle #5Merging (Combining)

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

Enhances the ease of initial deployment and anchoring of medical devices by eliminating the need for aggressive over-expansion, ensuring secure fixation without damaging the surrounding anatomy and maintaining device retention.

Implementation Method 1

the anchor being deformed to extend the anchor barb portion outside the second expanded profile

Methodology Applied
Scientific EffectDeformation: Deformation

Implementation Method 2

affecting a frictional or 'interference-fit' means of anchoring

Methodology Applied
Scientific EffectFriction: Friction

Data Source

PatentEP2442762B1Expandable medical device with a fixation anchor
Publication Date: 2020.04.08 WL GORE & ASSOC INC
  • EP2442762B1 patent drawingFigure 1A~1B
  • EP2442762B1 patent drawingFigure 2A~2B
  • EP2442762B1 patent drawingFigure 3

AI summary

A balloon expandable anchor (204) for a medical device (200). The anchor barb is contained within the device compacted delivery profile and is balloon expanded to rest outside of the expanded device profile.