Variable Caliber Biopsy Device for Minimally Invasive Tissue Sampling

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Solution Overview

Problem

Conventional core biopsy devices face limitations in accurately correlating tissue diagnosis with imaging, often causing trauma and adverse effects due to large outer diameters, and struggle to precisely visualize and retrieve small lesions, leading to invasive surgical procedures.

Innovation Solution

A biopsy device with a tubular coring and transport assembly of variable length and caliber, equipped with rotating cutting elements and a mechanism for gentle tissue penetration, allowing for multiple sample retrieval during a single insertion, and capable of delivering medications and markers for imaging and therapeutic purposes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If conventional core biopsy devices are used, then tissue samples can be retrieved, but the large outer diameter causes trauma and adverse effects

Engineering Contradiction:
Improvetissue traumaVSAvoidouter diameter
Core Design Contradiction:
Object-affected harmful factorsVSLength of moving object

Solution Approach 1:

The biopsy device divides the tissue sampling function into multiple independent coring elements that can be deployed sequentially. Each coring element has a small outer diameter for minimal trauma, while the ability to retrieve multiple samples compensates for the smaller size of individual samples.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Multiple coring elements are nested within a single delivery system, allowing them to be inserted through a small puncture site. The elements can be deployed one after another, enabling multiple samples to be retrieved through the same small access point, thus reducing overall tissue trauma.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Measurement precision

If conventional biopsy devices with large outer diameters are used, then larger tissue samples can be retrieved, but precise visualization and retrieval of small lesions is difficult

Engineering Contradiction:
Improvelesion visualization precisionVSAvoidouter diameter
Core Design Contradiction:
Measurement precisionVSLength of moving object

Solution Approach 1:

The device uses multiple small coring elements instead of a single large bore, allowing precise targeting of small lesions while maintaining the ability to retrieve adequate tissue samples through cumulative sampling.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Each coring element is designed with specific local characteristics optimized for precise lesion targeting, while the overall system provides the sample volume needed for diagnosis through multiple elements.

Inventive Principle:
Principle #3Local quality

3Measurement precision

If multiple biopsies are performed to ensure adequate sampling, then diagnostic accuracy improves, but patient trauma and procedure time increase

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidprocedure time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

Multiple coring elements are combined into a single integrated device that can retrieve multiple tissue samples during one insertion procedure. This merges what would otherwise require multiple separate biopsy procedures into a single event, reducing both procedure time and patient trauma while maintaining diagnostic accuracy.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The device enables continuous retrieval of multiple tissue samples in a single continuous procedure, eliminating the need to withdraw and re-insert the device between samples. This continuous action reduces procedure time and maintains sterile field integrity.

Inventive Principle:
Principle #20Continuity of useful action

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 minimally invasive core biopsy procedures with reduced trauma, improved sample correlation with imaging, and enhanced diagnostic accuracy by retrieving larger caliber specimens with minimal tissue damage and trauma.

Implementation Method 1

equipped with rotating cutting elements and a mechanism for gentle tissue penetration, allowing for multiple sample retrieval during a single insertion

Methodology Applied
Scientific EffectMechanical cutting: Friction

Implementation Method 2

The device includes a vacuum mechanism for drawing samples into the coring assembly

Methodology Applied
Scientific EffectVacuum suction: Suction

Data Source

PatentEP3003163B1Soft tissue coring biopsy devices and methods
Publication Date: 2020.10.14 TRANSMED7 LLC
  • EP3003163B1 patent drawingFigure 1
  • EP3003163B1 patent drawingFigure 2
  • EP3003163B1 patent drawingFigure 3

AI summary

An excisional device may comprise a work element configured to rotate at a first rotation rate and comprising a first and a second articulable beak configured to cut tissue. A first helical element, configured to transport tissue cut by the first and second articulable beaks, may be co-axially disposed relative to the work element and operative to rotate at a second rotation rate that is different than the work element. A proximal sheath may be co-axially disposed relative to the work element and the first helical element, and may be configured to rotate the work element and to actuate the first and second articulable beaks.