Biopsy Site Marker With Hydrogel Expansion Anchor

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Solution Overview

Problem

Existing biopsy markers may migrate from the biopsy site, leading to difficulties in identifying the correct location during subsequent follow-up procedures, as they do not remain fixed over time.

Innovation Solution

A biopsy marker system comprising a bioabsorbable hydrogel carrier with a radiopaque marker element, which expands within the tissue to anchor itself, ensuring visibility under ultrasound and minimizing migration through hydration, and a marker delivery device for precise deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a marker is placed at a biopsy site to assist relocation, then the biopsy site can be identified in subsequent procedures, but the marker may migrate from the biopsy site to another nearby location over time

Engineering Contradiction:
Improvemarker position stabilityVSAvoidmarker position stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The marker undergoes a parameter change from a compressed low-volume state during delivery to an expanded high-volume state after implantation. This volume expansion anchors the marker in the tissue, preventing migration and maintaining reliable position for biopsy site identification.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The marker transitions from a static compressed state during delivery to a dynamic expanded state after implantation. This dynamic transformation allows the marker to adapt to the tissue environment and secure itself against migration while maintaining visibility.

Inventive Principle:
Principle #15Dynamics

2Difficulty of detecting and measuring

If a marker is made visible under ultrasound for detection, then the biopsy site can be located accurately, but the marker material must be compatible with tissue absorption over time

Engineering Contradiction:
Improvemarker visibilityVSAvoidmarker retention time
Core Design Contradiction:
Difficulty of detecting and measuringVSDuration of action of stationary object

Solution Approach 1:

The marker uses a composite structure combining biodegradable polymer materials that are both ultrasound-visible and tissue-compatible. This allows the marker to maintain visibility for detection during the required period while gradually absorbing into tissue over time, balancing detectability with biocompatibility.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The marker incorporates radiopaque or echogenic materials that enhance its visibility under ultrasound and other imaging modalities. This allows accurate detection of the biopsy site while the biodegradable carrier gradually absorbs into tissue.

Inventive Principle:
Principle #32Color changes

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 maintains the marker in a fixed position, enhancing the accuracy of follow-up procedures by providing a stable and visible marker under imaging techniques like ultrasound, reducing the risk of misidentification.

Implementation Method 1

the marker may comprise a bioabsorbable hydrogel carrier and a marker element. The hydrogel carrier may be configured for absorption into the patient and to expand upon contact with moisture

Methodology Applied
Scientific EffectHydration: Absorption (physical)

Implementation Method 2

The hydrogel carrier may be configured for absorption into the patient and to expand upon contact with moisture

Methodology Applied
Scientific EffectHydrogel expansion: Hydrogel

Data Source

PatentEP4278985B1Biopsy site marker for limited migration
Publication Date: 2024.12.11 DEVICOR MEDICAL PRODUCTS INC
  • EP4278985B1 patent drawingFigure 1A~1C
  • EP4278985B1 patent drawingFigure 2
  • EP4278985B1 patent drawingFigure 3

AI summary

A biopsy site marker includes a carrier and a marker element. The marker element is disposed within the carrier. The carrier including a first marker material and a second marker material. The first marker material and the second marker material are each configured to expand in the presence of moisture. The first marker material is configured to expand at a rapid rate relative to the second marker material in the presence of moisture.