Biopsy Marker Delivery with Pressure-Ejected Anti-Migration Placement
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Solution Overview
Problem
Existing breast biopsy markers often migrate from the biopsy site, leading to difficulties in identifying the correct location during follow-up procedures, and there is a need for improved accuracy in marker placement and retention.
Innovation Solution
Development of bioabsorbable markers with expandable hydrogel carriers and radiopaque elements, along with marker delivery devices that ensure precise deployment and fixation within the biopsy site, utilizing features like dart configurations and pressure-induced ejection mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional markers are placed at biopsy sites, then marker placement is simple, but markers migrate from the biopsy site leading to identification difficulties
Solution Approach 1:
The marker delivery device transitions from a static loaded state to an active deployment state through pressure application. The deformable barrier dynamically responds to pressure changes, moving from a configuration that retains the marker to one that ejects the marker at the target site, enabling controlled marker placement while maintaining simplicity.
Solution Approach 2:
The system changes the physical state of the deformable barrier through pressure application. The barrier transitions from a relaxed state to a deformed state, which drives the marker ejection mechanism. This parameter change enables the marker to be delivered precisely to the biopsy site while maintaining device simplicity.
2Difficulty of detecting and measuring
If markers are made visible under imaging systems, then biopsy site identification is improved, but marker materials may cause tissue reactions
Solution Approach 1:
The marker system uses composite materials combining radiopaque substances (for imaging visibility) with biocompatible carriers (to minimize tissue reactions). The deformable barrier and marker elements are constructed from materials that provide both imaging contrast and tissue compatibility, resolving the contradiction between visibility and biocompatibility.
Solution Approach 2:
The deformable barrier acts as an intermediary that delivers the radiopaque marker elements to the target site while being composed of biocompatible materials itself. This intermediary structure enables the introduction of visible markers without directly exposing large amounts of potentially reactive materials to the tissue, minimizing tissue reactions while maintaining visibility.
3Manufacturing precision
If pressure is applied to eject markers, then marker deployment accuracy is improved, but device operation becomes more complex
Solution Approach 1:
The deformable barrier structure is designed to automatically convert applied pressure into directed marker ejection. The geometric configuration of the barrier and marker holder creates a self-service mechanism where pressure application naturally results in precise marker deployment without requiring additional actuation mechanisms or complex operational steps.
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 markers remain fixed at the biopsy site, enhancing visibility under ultrasound and x-ray, ensuring accurate relocation and minimizing migration, thereby facilitating precise identification during follow-up procedures.
Implementation Method 1
expandable hydrogel carriers
Implementation Method 2
radiopaque elements, enhancing visibility under ultrasound and x-ray
Data Source
AI summary
A marker delivery device includes a grip, a cannula, a push rod, and a marker element. The cannula extends distally from the grip. The push rod is configured to move within the cannula and includes a distal end with one or more seals configured to seal against an interior of the cannula. The marker element includes one or more barbs. The push rod is configured to generate a pressure within the cannula between the one or more seals and the marker element to eject the marker element from the cannula.