Biopsy Site Marker with Anchoring and Visualization

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Solution Overview

Problem

Existing biopsy site markers often migrate from their initial placement, leading to inaccuracies in identifying the biopsy site during subsequent follow-up procedures.

Innovation Solution

The development of a biopsy site marker with anchoring capabilities and enhanced visualization features, including a bioabsorbable carrier with hydrogel that expands to center the marker and prevent migration, and a radiopaque or echogenic marker element with distinct patterns for improved imaging visibility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a simple marker is placed at the biopsy site, then the marker is easy to implant, but the marker migrates to another location during the intervening time

Engineering Contradiction:
Improveease of implantationVSAvoidposition stability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The marker is divided into multiple segments or components including anchoring elements (such as barbs, hooks, or interlocking structures) that can engage with surrounding tissue. This segmentation allows the marker to be implanted simply while the distributed anchoring points prevent migration by distributing the mechanical engagement across multiple tissue interfaces.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The marker incorporates nested structures where inner components are housed within outer components. For example, anchoring elements may be stored within a delivery catheter and deployed after marker placement, or multiple functional layers are integrated concentrically. This nesting allows for simple initial implantation followed by activation of anchoring mechanisms to prevent migration.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Reliability

If a marker with anchoring features is used, then the marker position stability is improved, but the device complexity increases

Engineering Contradiction:
Improveposition stabilityVSAvoidmarker structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

Multiple functions are merged into a single integrated marker structure. The marker combines visualization features (radiopaque or echogenic materials), anchoring mechanisms (barbs, hooks, or interlocking elements), and tissue engagement features all in one component. This merging reduces the number of separate devices needed while achieving position stability through the integrated anchoring features.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The marker is designed as a multi-functional device that simultaneously provides visualization (through radiopaque/echogenic properties), anchoring (through mechanical engagement features), and tissue marking functions. This universality allows a single device to address multiple requirements without increasing overall system complexity, as all functions are embodied in one marker rather than requiring separate components.

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

3Measurement precision

If a marker with distinct patterns is used, then the visualization under imaging is improved, but the manufacturing complexity increases

Engineering Contradiction:
Improvebiopsy site identification accuracyVSAvoidmarker manufacturing simplicity
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The marker incorporates distinct patterns, colors, or radiographic densities that create a recognizable visual signature under imaging modalities. These patterns may be achieved through layered materials, embedded radiopaque markers in specific arrangements, or surface treatments that reflect ultrasound waves in characteristic patterns. The visual distinctiveness is achieved through material selection and arrangement rather than complex manufacturing processes.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The marker uses composite materials combining different properties in a single structure. For example, the marker may combine radiopaque materials with biocompatible polymers, or integrate echogenic surfaces with flexible body materials. These composite structures provide distinct imaging patterns while being manufactured through standard composite material processing techniques, avoiding excessive manufacturing complexity.

Inventive Principle:
Principle #40Composite materials

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 proposed marker effectively reduces migration and enhances visibility under ultrasound, ensuring accurate relocation of the biopsy site and facilitating subsequent surgical procedures.

Implementation Method 1

The carrier may include a hydrogel that absorbs fluid from the surrounding tissue to expand

Methodology Applied
Scientific EffectHydrogel: Hydrogel

Implementation Method 2

a hydrogel that absorbs fluid from the surrounding tissue to expand

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Implementation Method 3

a radiopaque or echogenic marker element with distinct patterns for improved imaging visibility

Methodology Applied
Scientific EffectEcho: Echo

Implementation Method 4

enhanced visualization features, including a bioabsorbable carrier with hydrogel that expands to center the marker and prevent migration, and a radiopaque or echogenic marker element with distinct patterns for improved imaging visibility

Methodology Applied
Scientific EffectX-Ray: X-Ray

Data Source

PatentUS20250025138A1Biopsy site marker with increased visualization and non-migration features
Publication Date: 2025.01.23 DEVICOR MEDICAL PRODUCTS INC
  • US20250025138A1 patent drawing
  • US20250025138A1 patent drawing
  • US20250025138A1 patent drawing

AI summary

A biopsy site marker includes a carrier, and a marker element. The marker element includes a base portion, a first anchor, and a second anchor. The base portion is at least partially disposed within the carrier. At least a portion of the first anchor and the second anchor extend laterally and outwardly away from the base portion. The first anchor and second anchor are configured to move relative to the base portion to engage tissue at a biopsy site. The base portion defines a plurality of curved sections disposed between the first anchor, the second anchor and a curved proximal end portion. The plurality of curved sections being configured to define a distinct appearance under x-ray visualization.