Biopsy Needle End-Deploy Hydrogel Marker
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Solution Overview
Problem
Current methods for marking biopsy sites after breast biopsies are not always satisfactory, particularly in terms of visibility under ultrasound and the risk of marker migration, and may not distinguish markers from microcalcifications during follow-up examinations.
Innovation Solution
A biopsy site marker system using a bioabsorbable hydrogel marker material with a radiopaque or echogenic element, which expands within the biopsy cavity to ensure visibility under ultrasound and is deployable through a marker delivery device, either side-deploy or end-deploy, to minimize migration and distinguish the marker from natural tissue features.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a marker is deployed through a side aperture of the biopsy needle, then the marker can be delivered to the biopsy site, but the marker may migrate and visibility under ultrasound may be insufficient
Solution Approach 1:
The patent inverts the conventional side-deploy approach by implementing end-deploy mechanism where the marker is deployed through the distal tip of the needle rather than through a side aperture. This reversal of deployment direction improves marker stability and ultrasound visibility while simplifying the overall device configuration.
Solution Approach 2:
The patent changes the physical state and properties of the marker material by using bioabsorbable hydrogel that transitions from a compressed delivery state to an expanded deployed state. This parameter change enables the marker to achieve sufficient size for ultrasound visibility and stability while maintaining compatibility with the needle delivery system.
2Loss of information
If a marker is deployed through a side aperture, then delivery is possible, but differentiation from microcalcifications during follow-up is difficult
Solution Approach 1:
The patent utilizes parameter changes by employing hydrogel material that undergoes significant volume expansion after deployment. The marker transitions from a small compressed state during delivery to a large expanded state in the tissue, achieving both easy delivery through the needle and sufficient size for clear differentiation from microcalcifications during ultrasound follow-up.
Solution Approach 2:
The patent employs composite material strategy by combining bioabsorbable hydrogel with radiopaque or echogenic elements. This composite structure provides both the expansion capability for tissue filling and the enhanced ultrasound visibility for clear differentiation from natural tissue features like microcalcifications.
3Reliability
If a conventional marker material is used, then delivery is straightforward, but ultrasound visibility and resistance to migration are insufficient
Solution Approach 1:
The patent applies parameter changes by designing a marker that exists in two distinct states: a small, compliant, easily deliverable compressed state during insertion, and a large, stable, highly visible expanded state after deployment. The hydrogel material's ability to change volume and physical properties resolves the contradiction between ease of delivery and marker retention.
Solution Approach 2:
The patent implements dynamics by creating a marker system that is not static but undergoes active transformation after deployment. The hydrogel continuously absorbs water and expands in situ, dynamically adapting to the tissue cavity and achieving optimal retention and visibility characteristics after insertion.
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 marks biopsy sites, ensuring visibility under ultrasound and reducing the risk of marker migration, while allowing for clear differentiation from microcalcifications, facilitating accurate relocation and monitoring of the biopsy site over time.
Implementation Method 1
the marker material is configured to absorb water from the surrounding tissue and expand
Implementation Method 2
a radiopaque or echogenic element, which expands within the biopsy cavity to ensure visibility under ultrasound
Data Source
Figure 1A~1C
Figure 2
Figure 3
AI summary
A needle for use with a biopsy device includes an outer cannula, and a tissue piercing tip. The outer cannula defines a cutter lumen for receiving a cutter therein and a lateral lumen adjacent to the cutter lumen. The tissue piercing tip has a body, a marker opening, and a marker lumen. The body defines a plurality of cutting surfaces. The marker opening is disposed on at least one cutting surface of the plurality of cutting surfaces. The marker lumen extends distally through the body from the marker opening to a proximal opening. The proximal opening is in communication with the cutter lumen.