Auto-aligning Biopsy Device via Spectroscopy
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Solution Overview
Problem
Current core needle biopsy (CNB) procedures often result in non-diagnostic samples due to insufficient tissue, leading to repeated procedures and potential complications, and the advent of molecular pathology tests requires more tissue, increasing the need for improved tissue quantification methods.
Innovation Solution
A spectroscopy system that auto-aligns a biopsy collecting device using an illumination subsystem, fixation subsystem, and detection subsystem to determine the amount of diagnostic tissue within the biopsy specimen without removing it from the needle, employing optical detection methods like diffuse optical spectroscopy to classify tissue and quantify diagnostic tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If core needle biopsy is performed to obtain tissue sample, then minimally invasive diagnosis is achieved, but insufficient diagnostic tissue is obtained leading to non-diagnostic samples
Solution Approach 1:
The patent performs optical spectroscopy analysis on the biopsy specimen immediately after extraction from the needle, before the needle is removed or the specimen is processed further. This preliminary measurement allows assessment of tissue adequacy before the specimen leaves the controlled environment of the biopsy device.
Solution Approach 2:
The patent replaces mechanical histopathological examination with optical spectroscopy analysis for initial tissue assessment. The optical system uses light interaction with tissue to obtain diagnostic information without requiring physical sectioning or staining procedures.
2Quantity of substance
If repeated biopsies are performed to obtain sufficient tissue, then adequate diagnostic sample is obtained, but patient complications increase and procedure time increases
Solution Approach 1:
The patent implements a feedback mechanism where optical spectroscopy measurements are taken on the biopsy specimen within the needle, and the results are used to determine whether the specimen contains sufficient diagnostic tissue. This immediate feedback eliminates the need for repeated procedures by providing real-time assessment of tissue adequacy.
Solution Approach 2:
The optical analysis is performed as a preliminary step before the biopsy specimen is removed from the needle or sent for conventional processing. This preliminary assessment prevents unnecessary repeated biopsies by identifying adequate specimens early in the workflow.
3Ease of manufacture
If biopsy specimen is removed from needle for analysis, then conventional histopathological examination can be performed, but tissue stress increases and diagnostic quality may deteriorate
Solution Approach 1:
The patent substitutes mechanical histopathological processing with optical spectroscopy analysis that can be performed in situ within the biopsy needle. This replacement eliminates the need for tissue sectioning, mounting, and staining procedures that subject the specimen to mechanical stress.
Solution Approach 2:
The optical spectroscopy system is designed to analyze the biopsy specimen while it remains in the needle, utilizing the needle itself as the sample holder. The system adapts to the existing biopsy configuration rather than requiring the specimen to be transferred to conventional processing equipment.
4Loss of information
If molecular pathology tests are performed on biopsy specimen, then comprehensive diagnostic information is obtained, but larger amount of viable tissue is required
Solution Approach 1:
The patent performs optical spectroscopy analysis as a preliminary assessment step before committing the biopsy specimen to molecular pathology tests. This preliminary evaluation ensures that the specimen contains sufficient viable tissue for both optical analysis and subsequent molecular testing, preventing wastage of precious samples.
Solution Approach 2:
The optical spectroscopy measurement provides feedback on the quality and quantity of viable tissue in the biopsy specimen, allowing clinicians to determine whether the sample is adequate for molecular pathology tests that require larger tissue amounts.
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 accurate classification and quantification of diagnostic tissue in situ, reducing the need for repeated biopsies, minimizing tissue stress, and streamlining the diagnostic process, thus improving patient outcomes and workflow efficiency.
Implementation Method 1
an illumination subsystem configured to emit an illumination light towards the biopsy collecting device
Implementation Method 2
configured to receive a light comprising at least one of an attenuated illumination light and a re-emitted light from the needle unit
Implementation Method 3
configured to receive a light comprising at least one of an attenuated illumination light and a re-emitted light from the needle unit
Data Source
AI summary
A spectroscopy system for auto-aligning a biopsy collecting device is presented. The spectroscopy system includes an illumination subsystem configured to emit an illumination light towards the biopsy collecting device, whereas the biopsy collecting device includes an activator unit and a needle unit and wherein the needle unit includes a cannula and a stylet having a biopsy specimen. Also, the spectroscopy system includes a fixation subsystem capable of holding the biopsy collecting device and configured to place the needle unit comprising the biopsy specimen across the illumination light. Further, the spectroscopy system includes a detection subsystem configured to receive a light comprising at least one of an attenuated illumination light and a re-emitted light from the needle unit. In addition, the detection subsystem is configured to send a control signal to align the needle unit at a predetermined position in the spectroscopy system based on the received light.