Biopsy Packaging Container for Recovering Dislodged Cells
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Solution Overview
Problem
The imbalance between tissue yield from core needle biopsies and the amount needed for diagnostic testing leads to tissue exhaustion, with valuable dislodged cells (D-cells) being discarded, impacting diagnostic quality and patient care.
Innovation Solution
A packaging container designed for medical devices that segregates and preserves dislodged cells (D-cells) during biopsy procedures, allowing them to be recovered and used for molecular testing, while maintaining the integrity of the tissue sample.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If core needle biopsy is used to obtain tissue samples, then the invasiveness and cost are reduced, but the tissue yield is insufficient for comprehensive diagnostic testing
Solution Approach 1:
The biopsy needle is divided into multiple chambers (first chamber for tissue, second chamber for dislodged cells) that separately collect different components during the biopsy procedure. This segmentation allows preservation of all cellular material without compromising the simplicity of the biopsy procedure.
Solution Approach 2:
The invention adds a vertical dimension to tissue collection by incorporating a second chamber below the first chamber in the needle assembly. This dimensional arrangement enables separate collection of dislodged cells that fall during the biopsy, effectively increasing total tissue yield without making the procedure more invasive.
2Ease of operation
If standard biopsy handling practices are used, then the procedure is simple, but dislodged cells are discarded with medical waste
Solution Approach 1:
The second chamber acts as an intermediary collection vessel that captures dislodged cells during the biopsy procedure. Instead of cells being lost to waste, they are funneled into this intermediate chamber, preserving valuable diagnostic material while maintaining simple handling procedures.
Solution Approach 2:
The invention transforms the previously discarded dislodged cells into a recoverable resource. The second chamber is designed to collect these cells, and both chambers can be transported together to the laboratory where the cells are recovered and used for diagnostic testing, eliminating waste while keeping operations simple.
3Stability of the object's composition
If tissue is fixed with formalin for standard pathology processing, then tissue preservation is achieved, but molecular testing quality is compromised
Solution Approach 1:
The needle assembly segments tissue collection into two separate chambers: one for formalin-fixed tissue suitable for pathology, and another for dislodged cells preserved in a different medium optimized for molecular testing. This segmentation allows each sample type to be processed with appropriate preservation methods, maintaining both tissue stability and molecular testing quality.
Solution Approach 2:
Different preservation conditions are applied locally to different sample types. The first chamber uses formalin for tissue fixation, while the second chamber uses a preservation medium suitable for maintaining cellular integrity for molecular analysis. This local quality approach ensures optimal results for each diagnostic modality.
4Ease of operation
If smaller tissue samples are taken to reduce patient trauma, then patient comfort and procedure speed improve, but diagnostic information quality decreases
Solution Approach 1:
The invention recovers previously discarded dislodged cells that contain valuable diagnostic information. By collecting these cells in the second chamber during the rapid biopsy procedure, the system preserves molecular diagnostic information without requiring larger tissue samples or slower procedures.
Solution Approach 2:
The invention creates a complementary copy of the tissue sample in cellular form. The dislodged cells collected in the second chamber serve as a cellular copy that can be used for molecular testing, providing diagnostic information that complements the solid tissue sample from the first chamber.
Data Source
AI summary
A packaging container for a medical device is disclosed herein. In an embodiment, the packaging container includes an inner part and an outer part. The inner part has a rack surface with at least one cutout configured to hold one or more medical device both during shipping and upright during use. The outer part encloses the inner part and includes a tear line enabling a user to remove a portion thereof and expose the rack surface so that the user can use the medical device while held upright. In an embodiment, the inner part is formed by a single sheet of cardboard folded along a plurality of fold lines to form the rack surface, and the outer part is formed by a single sheet of cardboard folded along a plurality of fold lines to form the enclosure.