Rotating Biopsy Needle with Bioimpedance Guidance

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Solution Overview

Problem

Current biopsy procedures face challenges such as inadequate tissue samples, mechanical damage to tissues, and complications like bleeding or pneumothorax due to the need for multiple needle passes and inadequate guidance during minimally-invasive needle biopsies, particularly in procedures like lung biopsies.

Innovation Solution

A biopsy system featuring a deployable cutting mechanism with a tangential cutting mechanism and low-energy electrocoagulation to harvest larger tissue volumes while minimizing bleeding risks, combined with bioimpedance measurements for improved needle guidance and positioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If multiple needle passes are performed to collect sufficient tissue cores, then the tissue sample volume is improved, but the risk of complications such as bleeding and procedural time increase

Engineering Contradiction:

Improvetissue sample volumeVSAvoidrisk of complications

Core Design Contradiction:

Quantity of substanceVSReliability

Solution Approach 1:

The cutting mechanism is divided into multiple cutting edges arranged circumferentially around the needle shaft, allowing simultaneous cutting action that harvests larger tissue volume in a single pass, eliminating the need for multiple sequential passes

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The cutting mechanism features a rotating component that spins during needle advancement through tissue, enabling the cutting edges to engage tissue dynamically and harvest adequate sample volume in one rotational motion rather than requiring multiple static passes

Inventive Principle:

Principle #15Dynamics

2Quantity of substance

If multiple needle passes are performed to collect sufficient tissue cores, then the tissue sample volume is improved, but the procedural time and post-procedural monitoring time increase

Engineering Contradiction:

Improvetissue sample volumeVSAvoidprocedural time

Core Design Contradiction:

Quantity of substanceVSLoss of time

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The rotating cutting mechanism performs continuous cutting action during a single needle advancement, maintaining useful cutting function throughout the entire insertion process rather than requiring intermittent multiple passes

Inventive Principle:

Principle #20Continuity of useful action

3Quantity of substance

If a larger needle is used to obtain more tissue in a single pass, then the tissue sample volume is improved, but the risk of complications such as bleeding and organ-specific complications increases

Engineering Contradiction:

Improvetissue sample volumeVSAvoidrisk of complications

Core Design Contradiction:

Quantity of substanceVSReliability

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Inventive Principle:

Principle #15Dynamics

4Measurement precision

If external imaging-based guidance is used for needle positioning, then the guidance capability is improved, but the response time is delayed due to breath-holding requirements and image interpretation time

Engineering Contradiction:

Improveneedle positioning accuracyVSAvoidresponse time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The system replaces external imaging-based mechanical guidance with an electrical field-based sensing system that continuously monitors tissue impedance around the needle, providing real-time positional feedback without requiring breath-holding or external imaging equipment

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The electrical sensing system provides continuous real-time feedback on needle position and tissue contact through impedance measurements, allowing immediate adjustment without the delayed feedback loop inherent in external imaging systems that require acquisition, interpretation, and triangulation time

Inventive Principle:

Principle #23Feedback

5Object-affected harmful factors

If standard core needle biopsy is used to harvest tissue, then the procedure is minimally-invasive, but the tissue sample volume is insufficient for comprehensive diagnostic testing

Engineering Contradiction:

Improveminimally-invasive natureVSAvoidtissue sample volume

Core Design Contradiction:

Object-affected harmful factorsVSQuantity of substance

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

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

The system enables more efficient tissue harvesting with reduced procedural time and complications, improving the yield of biopsy samples and reducing the risk of bleeding by using a tangential cutting mechanism and low-energy electrocoagulation, while bioimpedance measurements enhance needle placement accuracy.

Implementation Method 1

rotating the needle and applying suction to the lumen, thereby cutting the tissue with the cutting mechanism and cauterizing the tissue with the cauterization mechanism

Methodology Applied

Scientific EffectTangential cutting:

Implementation Method 2

low-energy electrocoagulation to harvest larger tissue volumes while minimizing bleeding risks

Methodology Applied

Scientific EffectElectrocoagulation:

Implementation Method 3

applying suction to the lumen, thereby cutting the tissue with the cutting mechanism

Methodology Applied

Scientific EffectSuction: Suction

Implementation Method 4

multi-bioimpedance measurements for guiding a needle and directing electrical coagulation

Methodology Applied

Scientific EffectBioimpedance: Electrical Impedance Tomography

Data Source

PatentUS20240407770A1Biopsy system for enhanced tissue harvesting

Publication Date: 2024.12.12 DATA DRIVE DIAGNOSTIC SCIENCES INC

AI summary

A biopsy system for harvesting larger volumes of tissue as compared to standard core biopsy needles. The system has a needle with a lumen, an aperture disposed at the distal end of the needle and connected to the lumen, and a cutting mechanism adapted to cut tissue. When the needle is rotated after it is inserted into a target tissue, the cutting mechanism cuts from the tissue and directs the cut tissue portions into the lumen. Multi-bioimpedance measurements are used to guide a needle and direct the application of electricity for cauterizing tissue.