Biodegradable Biopsy Marker with Calcifying Core for Multi-Modality Imaging

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Solution Overview

Problem

Existing tissue markers are not visible under all available imaging modalities, making it difficult to locate tumors accurately during treatment, especially after shrinkage due to chemotherapy or irradiation, which complicates the conservation of breast tissue.

Innovation Solution

A biopsy marker with a biodegradable foam structure embedded with biological tissue susceptible to calcification, providing visibility under both ultrasonic and radiation-based imaging modalities, where the calcification process enhances visibility over time.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a single-material marker is used for tissue marking, then the marker structure is simple, but the marker is not visible under all imaging modalities

Engineering Contradiction:

Improvevisibility under multiple imaging modalitiesVSAvoidmarker structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent employs composite materials consisting of biodegradable foam (providing ultrasonic visibility through gas-filled pores) and radiopaque materials (enabling X-ray and MRI visibility). This composite structure allows the single marker to be visible under multiple imaging modalities including ultrasound, X-ray, and MRI, resolving the contradiction between versatility and complexity by integrating multiple functional materials into one unified marker structure

Inventive Principle:

Principle #40Composite materials

2Duration of action of stationary object

If permanent non-biodegradable materials are used for markers, then the marker remains visible long-term, but the marker cannot be absorbed by the host tissue

Engineering Contradiction:

Improvemarker visibility durationVSAvoidforeign body presence

Core Design Contradiction:

Duration of action of stationary objectVSObject-generated harmful factors

Solution Approach 1:

The patent utilizes parameter changes in the material properties over time. The biodegradable foam component gradually degrades and is absorbed by host tissue through hydrolysis and enzymatic breakdown, transforming from a permanent foreign body into absorbable byproducts. This time-dependent parameter change allows the marker to provide long-term visibility while ultimately being eliminated by the body, resolving the contradiction between duration and harmful effects

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The biodegradable foam component is designed to be discarded by the host tissue through natural metabolic processes. The gas-filled pores and foam structure are broken down into absorbable molecules that can be processed and eliminated by the body's waste removal systems, allowing the marker to fulfill its marking function temporarily while avoiding long-term foreign body complications

Inventive Principle:

Principle #34Discarding and recovering

3Reliability

If a marker provides long-term visibility, then the tumor can be located repeatedly, but the marker may interfere with tissue conservation after tumor shrinkage

Engineering Contradiction:

Improvetumor localization accuracyVSAvoidinterference with tissue conservation

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs parameter changes in marker visibility over time. The biodegradable foam provides strong ultrasonic contrast initially for accurate tumor localization, then gradually degrades as the tumor responds to treatment and shrinks. This time-dependent parameter change ensures the marker remains visible when needed for localization but diminishes as treatment progresses, reducing interference with tissue conservation efforts

Inventive Principle:

Principle #35Parameter 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 marker allows for precise localization of the biopsy site using multiple imaging techniques, reducing the number of procedures needed for cancer detection and treatment by being visible under both ultrasound and MRI/X-ray imaging.

Implementation Method 1

The foam material provides ultrasonic visibility to access the implantation site

Methodology Applied

Scientific EffectUltrasonic imaging: Ultrasound

Implementation Method 2

The biological tissue undergoes calcification in 30 days to 5 years depending on the chemistry of biological tissue used. The calcification generated in the biological tissue provides visibility in magnetic resonance imaging (MRI) and X-ray imaging

Methodology Applied

Scientific EffectCalcification: Crystallisation

Data Source

PatentUS9042965B2Biopsy marker with in situ-generated imaging properties

Publication Date: 2015.05.26 CR BARD INC

AI summary

An intracorporeal marker, for marking a site within living tissue of a host, includes an outer body portion of biodegradable material. An inner body portion is located in the outer body portion. The inner body portion includes biological material that becomes calcified in the living tissue of the host over time. An agent interacts with the biological material to promote calcification of the biological material of the inner body portion in the living tissue of the host.