Single-Insertion Biopsy Device with Integrated Marker Release

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Solution Overview

Problem

Current biopsy devices require multiple insertions for multiple sampling, which can cause pain and scarring, and often fail to accurately deposit markers at the biopsied site due to additional steps involving different devices.

Innovation Solution

A single-insertion, multiple sampling biopsy device with integrated marker release, featuring a stylet with a shuttle mechanism that transports tissue samples from the distal end to the proximal end without removing the needle, and a transport subassembly that includes nested shuttles and a spooling tape for efficient sample collection and marker deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If multiple tissue samples are collected using traditional biopsy devices, then multiple insertions are required, but this causes patient pain and scarring

Engineering Contradiction:
Improvenumber of tissue samplesVSAvoidpatient pain and scarring
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The biopsy device is divided into multiple independent sampling chambers (first chamber, second chamber, etc.) that can each capture tissue samples separately. This segmentation allows multiple samples to be obtained through a single insertion, eliminating the need for repeated needle insertions and thus reducing patient pain and scarring while maintaining the ability to collect multiple tissue specimens for comprehensive diagnosis

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The biopsy device is designed with multi-functionality to perform both multiple tissue sampling and marker deployment through a single insertion. The device includes multiple sampling chambers for collecting tissue samples and an integrated marker deployment mechanism that can place markers at the biopsied site, consolidating what would traditionally require separate procedures into one universal tool, thereby reducing patient discomfort

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If different devices are used for biopsy and marker deployment, then marker deposition accuracy decreases, but using a single device improves accuracy

Engineering Contradiction:
Improvemarker deposition accuracyVSAvoiddevice integration
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The biopsy device merges the tissue sampling function with the marker deployment function into a single integrated system. The marker deployment mechanism is combined with the sampling chambers and needle structure, allowing the same device that collects tissue samples to also accurately deposit markers at the biopsied site. This integration ensures precise marker placement relative to the sampled location, improving diagnostic accuracy while managing device complexity through functional consolidation

Inventive Principle:
Principle #5Merging (Combining)

3Adaptability or versatility

If a single biopsy device performs multiple functions, then device complexity increases, but separate devices require multiple procedures

Engineering Contradiction:
Improvedevice functionalityVSAvoiddevice structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The biopsy device employs a nested structure where multiple sampling chambers are arranged concentrically or in sequence along the needle shaft. The first sampling chamber, second sampling chamber, and additional chambers are positioned within or alongside each other, allowing the device to maintain a compact form factor while providing multiple independent sampling capabilities. This nesting approach increases versatility without proportionally increasing overall device complexity

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The biopsy device incorporates dynamic mechanisms that allow the sampling chambers and marker deployment components to be activated in sequence or selectively during a single insertion procedure. The device can dynamically transition between sampling modes and marker deployment modes, providing adaptability and versatility while managing structural complexity through controlled activation of different functional elements

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS11849928B2Single-insertion, multiple sampling biopsy device usable with various transport systems and integrated markers
Publication Date: 2023.12.26 CR BARD INC
  • US11849928B2 patent drawing
  • US11849928B2 patent drawing
  • US11849928B2 patent drawing

AI summary

A marker system includes a biopsy apparatus having a cannula and a stylet. The cannula has a distal end, the stylet has a distal stylet tip, and the stylet is received in the cannula. A tissue marker is coupled to the distal stylet tip. The tissue marker is configured to be contacted by the distal end of the cannula. The tissue marker is detached from the stylet distal tip by either of a proximal movement of the stylet relative to the cannula or a distal movement of the cannula relative to the stylet.