Core Needle Biopsy Device Single Insertion Multiple Samples
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Solution Overview
Problem
Current core needle biopsy devices are limited to collecting a single tissue sample per insertion, whereas vacuum-assisted biopsy devices can collect multiple samples without removing the probe from the breast.
Innovation Solution
A core needle biopsy device design that allows for single insertion with multiple sample collection, utilizing a needle assembly with a piercer and a cutter that can be driven through a cutting cycle and tissue acquisition cycle to collect multiple tissue samples.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a core needle biopsy device uses a sharp solid piercer with a lateral tissue receiving notch and an elongate hollow cutting sheath, then the device can collect one tissue sample per insertion, but the device cannot collect multiple tissue samples without removing the piercer and cutting sheath from the patient
Solution Approach 1:
The patent implements a nested structure where the cutter is positioned inside the hollow needle, and the tissue sample is captured within a cavity formed by the interaction between the cutter and the hollow needle. This nested arrangement allows multiple cutting cycles to occur within a single insertion, enabling multiple tissue samples to be collected without removing the piercer and cutting sheath from the patient, thereby resolving the contradiction between sample collection productivity and device structure complexity
Solution Approach 2:
The patent divides the tissue sampling process into multiple discrete cutting cycles, where the cutter sequentially segments different portions of tissue during a single insertion. This segmentation approach allows the device to collect multiple tissue samples by performing repeated cutting actions within the same insertion, improving productivity while maintaining a relatively simple device structure
2Productivity
If a vacuum-assisted biopsy device uses a hollow needle with a lateral aperture and a hollow cutter moved axially to sever tissue samples, then multiple samples can be collected without removing the probe, but the needle size is larger and may increase patient anxiety
Solution Approach 1:
The patent applies local quality by using a solid sharp piercer instead of a hollow needle, concentrating the cutting function in a localized cutter that moves within the hollow needle. This localized approach allows the majority of the needle structure to be smaller and more compact, reducing patient anxiety while still enabling multiple tissue samples to be collected through the axial movement of the cutter, thus resolving the contradiction between productivity and patient comfort
Data Source
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AI summary
A core needle biopsy device including a needle assembly, a cutter drive assembly, a piercer drive assembly and a piercer retraction assembly. The needle assembly includes a piercer and a hollow cutter. The piercer includes a sharp distal tip and a notch proximal to the distal tip. The piercer is slidably disposed within the cutter to sever a tissue sample into the notch. The cutter drive assembly is configured to selectively fire the cutter. The piercer drive assembly is configured to selectively fire the piercer. The piercer retraction assembly is configured to retract the piercer independently of the cutter while the needle assembly is disposed within a patient to expose the notch of the piercer to an exterior of a patient.