Core Needle Biopsy Analyte Recovery Without Formalin Damage
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Solution Overview
Problem
Conventional core needle biopsies (CNBs) face limitations in providing sufficient tissue for molecular or genetic tests due to the use of formalin, which damages analytes like nucleic acids, and the separation of dislodged cells is not efficiently accounted for, leading to inconclusive results and the need for further testing.
Innovation Solution
A method and system for recovering assessable analytes (DNA, RNA, exosomes, or proteins) from CNB samples by immersing the needle in a buffer solution, swirling to dislodge cells, filtering, and adding a cell lysis and stabilization reagent without exposing the analytes to formalin, allowing for separate processing of the tissue core and dislodged cells.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If formalin is used to preserve tissue samples from core needle biopsies, then tissue integrity is maintained, but analytes like nucleic acids are damaged and become unusable for molecular or genetic tests
Solution Approach 1:
The tissue sample processing is segmented into two separate pathways: one for tissue core preservation (using formalin) and another for analyte recovery (using buffer solution). This segmentation allows each component to be treated with the most appropriate method for its specific requirements, resolving the contradiction between tissue integrity and analyte preservation
Solution Approach 2:
The harmful formalin is extracted from the analyte recovery process. Instead of using formalin for all tissue samples, the invention extracts only the necessary portion for histological examination and recovers analytes from the buffer solution portion, eliminating the harmful effect of formalin on nucleic acids while maintaining tissue preservation capabilities
2Reliability
If conventional processing methods are used, then tissue samples can be examined histologically, but sufficient assessable analytes are not available for molecular or genetic tests
Solution Approach 1:
The invention merges two previously separate processes into a unified workflow: conventional histological processing and molecular analyte recovery. By combining these processes and allowing them to occur simultaneously from the same initial sample, the system ensures both tissue integrity for histology and sufficient analyte quantity for molecular testing
3Ease of operation
If dislodged cells are not separately processed, then the procedure is simpler, but diagnostic information is lost and further testing is required
Solution Approach 1:
The buffer solution serves multiple functions simultaneously: it acts as a preserving medium for analytes, a collection medium for dislodged cells, and a transport medium for both tissue and cells. This multi-functionality allows comprehensive diagnostic information recovery without adding significant procedural complexity
Solution Approach 2:
The buffer solution is prepared in advance and positioned to receive both the tissue core and dislodged cells during the biopsy procedure itself. This preliminary preparation ensures that no diagnostic information is lost and eliminates the need for subsequent complex retrieval procedures
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
Enables efficient recovery of analytes for diagnostic and molecular testing, reducing the need for further procedures, lowering skill requirements, and minimizing the risk of false results, while maintaining tissue integrity and cellularity.
Implementation Method 1
immersing the needle in a buffer solution, swirling to dislodge cells
Implementation Method 2
adding a cell lysis and stabilization reagent
Data Source
AI summary
Implementations include methods and systems for recovering an analyte from a tissue sample extracted via a core needle biopsy. The method may involve immersing the core needle holding the tissue sample in a sterilized buffer solution without formalin. Swirling of the needle may dislocate the tissue core and cells for creation of an intermediate mixture. This mixture may be filtered using a strainer into a sample tube to separate the tissue core resulting in another intermediate mixture. Equal volume of a cell lysis and stabilization reagent may be added to this mixture to yield a third mixture containing lysed dislodged cells. The assessable analyte, unexposed to formalin, may then be isolated. The system for this procedure may include a core needle, a buffer container, a sample tube, a strainer and a potential container for tissue core storage. The analyte could be DNA, RNA, an exosome, or a protein.