Biopsy System Segmented Needle Cartridge Preservation
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Solution Overview
Problem
Current biopsy procedures require repeated needle insertions, leading to tissue damage and variations in biomolecular profiles due to delayed sample preservation, and are limited by the size of the biopsy device, which increases the risk of hemorrhage and injury.
Innovation Solution
A core biopsy system with a downloading mechanism that allows for fast and simple extraction of tissue samples into a small cartridge, eliminating the need for a co-axial introducer and reducing the device's size, while enabling rapid preservation through cooling or chemical methods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a co-axial introducer is used to enable multiple biopsy samples without repeated insertions, then the number of tissue insertions is reduced, but the outer diameter of the inserted device increases leading to higher risk of hemorrhage and injury
Solution Approach 1:
The device is segmented into a reusable outer introducer needle and a disposable inner biopsy needle assembly. This allows the introducer to remain in place for multiple samples while the inner needle is exchanged, reducing the need for repeated skin punctures while avoiding the need for a large-bore co-axial system for the entire procedure
Solution Approach 2:
The inner biopsy needle assembly is designed as a disposable component that is discarded after a single use, eliminating the need for complex sterilization and reuse protocols. This allows for a simpler, smaller introducer design while maintaining the ability to obtain multiple samples through controlled exchanges of the disposable inner needle
2Stability of the object's composition
If samples are preserved immediately after acquisition, then the biomolecular profile remains stable, but the complexity of the biopsy device increases due to integrated preservation mechanisms
Solution Approach 1:
The preservation function is extracted from the biopsy needle itself and transferred to a separate preservation medium contained in a cartridge or container. The needle simply deposits the tissue sample into the preservation medium, which then maintains sample stability. This separation allows the needle to remain simple while achieving immediate preservation
Solution Approach 2:
A preservation medium (such as formalin, RNA stabilization reagent, or frozen storage medium) acts as an intermediary between the tissue sample and the environment. This medium is introduced into the body cavity or held ready at the procedure site, allowing immediate stabilization of the sample upon deposition without requiring complex integrated preservation mechanisms in the needle
3Quantity of substance
If multiple biopsy samples are acquired using conventional methods, then sufficient tissue for analysis is obtained, but the time between sample acquisition and preservation varies leading to biomolecular changes
Solution Approach 1:
Preservation medium is prepared and positioned in advance, either in a cartridge attached to the biopsy device or in a container ready at the procedure site. This preliminary preparation allows immediate preservation of each sample as it is acquired, eliminating delays. The system is pre-configured to handle multiple samples sequentially with consistent rapid preservation for each
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 multiple biopsy samples to be obtained without repeated insertions, minimizing tissue damage and preserving samples quickly to maintain a stable biomolecular profile, reducing the risk of hemorrhage and injury.
Implementation Method 1
The cartridge preserves the samples either by cooling or by chemical preservation or both
Implementation Method 2
The cartridge preserves the samples either by cooling or by chemical preservation or both
Data Source
AI summary
A core biopsy system includes a core biopsy needle device and biopsy sample collection device, wherein the core biopsy needle device is positionable within and movable with respect to the biopsy sample collection device. Systems and methods for obtaining multiple biopsy samples with a single insertion of a needle of the biopsy needle device include obtaining sequential samples and storage in a multi-cell cartridge. Additional features and methods of the invention include obtaining two sample portions from each sample acquisition, wherein each of the two sample portions can be separately preserved and analyzed.