Biopsy Device Tip with Curved Cutting Edges for MRI Compatibility

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Solution Overview

Problem

Existing electrosurgical biopsy devices are not suitable for use in conjunction with magnetic resonance imaging and often fail to ensure proper placement of biopsy or surgical devices, particularly in subcutaneous sites like the human breast.

Innovation Solution

A tissue accessing and severing device comprising an elongated probe component with a tissue-cutting member and a driver component, which includes a tissue penetrating distal tip with concave surfaces forming curved cutting edges, and a system for vacuum-assisted specimen collection, allowing precise access and removal of tissue specimens with adjustable aperture orientation and cutting motion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electrosurgical biopsy devices are used to access intracorporeal sites, then tissue access and removal is effective, but the devices are not suitable for use in conjunction with magnetic resonance imaging

Engineering Contradiction:

Improvesuitability for MRI compatibilityVSAvoidelectrosurgical functionality

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent removes the electrosurgical cutting mechanism from the biopsy device, extracting the problematic component that causes MRI incompatibility. The device now uses a purely mechanical cutting member that advances through the tissue to sever it, eliminating electrical components while maintaining effective tissue access and removal capabilities

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The biopsy device is designed to be universally compatible with both MRI imaging and effective tissue biopsy procedures. The mechanical cutting mechanism serves multiple functions: it cuts tissue without electrical interference (enabling MRI compatibility) while still providing effective tissue access and removal (maintaining biopsy functionality)

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Ease of operation

If needle like tips are used to access intracorporeal sites, then insertion is facilitated, but proper placement of the biopsy device is not always ensured

Engineering Contradiction:

Improveinsertion easeVSAvoidplacement accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The distal tip is designed with a curved geometry featuring concave surfaces that form curved cutting edges. This curved configuration facilitates smooth tissue penetration while the specific geometric design ensures proper orientation and placement of the biopsy device within the target site

Inventive Principle:

Principle #14Spheroidality (Curvature)

Solution Approach 2:

The patent employs radiopaque material in the distal tip and/or aperture region, which appears as a distinct signal on imaging devices. This visual indicator allows operators to precisely verify device placement and orientation during the procedure, ensuring accurate positioning while maintaining ease of insertion

Inventive Principle:

Principle #32Color changes

3Device complexity

If the aperture in the tubular section is fixed in orientation, then device structure is simplified, but proper orientation for biopsy specimen capture is not always achieved

Engineering Contradiction:

Improveaperture orientation mechanismVSAvoidspecimen capture effectiveness

Core Design Contradiction:

Device complexityVSEase of operation

Solution Approach 1:

The tubular section is designed to be rotatable relative to the longitudinal axis, transforming the aperture orientation from a fixed state to a dynamic, adjustable state. This rotational capability allows the aperture to be oriented optimally for capturing biopsy specimens from different directions while maintaining relatively simple device structure through the use of straightforward rotational joints

Inventive Principle:

Principle #15Dynamics

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 precise and efficient access and removal of tissue specimens from targeted sites within the body, suitable for both diagnostic and therapeutic procedures, while maintaining compatibility with MRI and minimizing surgical intrusion.

Implementation Method 1

A vacuum source is in fluid communication with the inner lumen to draw tissue through the aperture into the inner lumen of the tubular section

Methodology Applied

Scientific EffectVacuum: Vacuum

Data Source

PatentUS11246574B2Biopsy device with aperture orientation and improved tip

Publication Date: 2022.02.15 SENORX INC

AI summary

A biopsy device includes an elongated probe having a central longitudinal axis, a proximal end, and a distal end. A tissue penetrating tip includes a proximal base and a sharp distal point. The proximal base is secured to the distal end of the elongated probe. The sharp distal point is distal to the proximal base and is aligned with the central longitudinal axis. The tissue penetrating tip has a plurality of concave surfaces annularly arranged to form at least three adjacent pairs of concave surfaces. Each concave surface of the plurality of concave surfaces extends from the proximal base to the sharp distal point. Each adjacent pair of concave surfaces intersect to form a concave curved cutting edge. Cumulatively, the at least three adjacent pairs of concave surfaces form a plurality of concave curved cutting edges that distally terminate at the sharp distal point.