Variable Stiffness Aspiration Needle for Tissue Biopsy

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Solution Overview

Problem

Current needle biopsy procedures face challenges in acquiring sufficient tissue samples, especially in navigating through tortuous body paths and preventing sample loss due to the rigidity of traditional needles.

Innovation Solution

A needle design with a distal portion of high stiffness for tissue penetration and a proximal portion with reduced stiffness, achieved through various modifications such as laser-cut openings, spiral patterns, or braided structures, allowing flexibility while maintaining column strength, along with a sleeve for sample retention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a traditional rigid needle is used for tissue penetration, then penetration capability is improved, but navigation through tortuous body paths becomes difficult

Engineering Contradiction:
Improvepenetration capabilityVSAvoidnavigation through tortuous paths
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The needle body is divided into multiple segments with different stiffness characteristics - a distal portion with high stiffness for penetration and a proximal portion with reduced stiffness for flexibility. This segmentation allows each portion to perform its specialized function independently, resolving the contradiction between penetration strength and navigational flexibility.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different portions of the needle body are given different local properties - the distal portion maintains high stiffness while the proximal portion has reduced stiffness through modifications such as laser-cut openings, spiral patterns, or braided structures. This local differentiation enables the needle to simultaneously achieve penetration capability and tortuous path navigation.

Inventive Principle:
Principle #3Local quality

2Stability of the object's composition

If a rigid needle structure is used, then structural stability is improved, but sample loss during retrieval occurs due to inability to navigate complex paths

Engineering Contradiction:
Improvestructural stabilityVSAvoidsample retention
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The needle is segmented into rigid and flexible portions, where the rigid distal portion maintains structural stability during penetration while the flexible proximal portion enables safe navigation through complex body paths during sample retrieval, preventing sample loss.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The proximal portion incorporates flexible structures such as braided patterns, spiral cuts, or mesh structures that provide controlled flexibility. These flexible elements allow the needle to bend and navigate tortuous paths without compromising the overall structural integrity needed for sample containment.

Inventive Principle:
Principle #30Flexible shells and thin films

3Force

If the entire needle body has high stiffness, then penetration force is improved, but flexibility for navigating tortuous paths is reduced

Engineering Contradiction:
Improvepenetration forceVSAvoidflexibility for navigation
Core Design Contradiction:
ForceVSAdaptability or versatility

Solution Approach 1:

The needle body is segmented into a distal high-stiffness portion that generates sufficient penetration force and a proximal low-stiffness portion that provides the flexibility needed for navigating tortuous anatomical paths, allowing both force generation and adaptability to be optimized simultaneously.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different local regions of the needle are engineered with different stiffness qualities - the distal region maintains high stiffness for forceful penetration while the proximal region incorporates flexibility-inducing features such as laser-cut openings, spiral patterns, or braided structures for adaptable navigation.

Inventive Principle:
Principle #3Local quality

4Ease of operation

If a flexible needle structure is used, then navigation through tortuous paths is improved, but penetration capability is reduced

Engineering Contradiction:
Improvenavigation through tortuous pathsVSAvoidpenetration capability
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The needle is segmented so that only the distal portion required for penetration maintains high stiffness, while the proximal portion used for navigation incorporates flexibility. This ensures that penetration capability is concentrated where needed without requiring the entire needle to be rigid.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The needle exhibits local quality differentiation where the distal portion has high stiffness for penetration while the proximal portion has reduced stiffness through structural modifications, allowing each region to perform its specialized function optimally.

Inventive Principle:
Principle #3Local quality

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 efficient tissue sample acquisition and navigation through complex body paths while preventing sample loss, ensuring effective sample collection and retrieval.

Implementation Method 1

a proximal portion of the body having a second stiffness less than the first stiffness

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

the proximal portion may be formed of an elastic spring member affixed to a proximal end of the distal portion

Methodology Applied
Scientific EffectSpring: Spring

Implementation Method 3

a sharp tip for penetrating a target tissue

Methodology Applied
Scientific EffectMechanical Force: Mechanical Force

Implementation Method 4

a channel extending therethrough for collecting a tissue sample therein

Methodology Applied
Scientific EffectSuction: Suction

Data Source

PatentEP3261553B1Variable stiffness aspiration needle
Publication Date: 2020.05.20 BOSTON SCIENTIFIC SCIMED INC
  • EP3261553B1 patent drawingFigure 1~3
  • EP3261553B1 patent drawingFigure 4~5
  • EP3261553B1 patent drawingFigure 6~7

AI summary

A needle for collecting a tissue samples includes a needle body extending along a longitudinal axis from a proximal end to a distal end including a sharp tip for penetrating a target tissue. The needle body includes a channel extending therethrough for collecting a tissue sample therein when the distal end is inserted into the target tissue. A distal portion of the needle body has a first stiffness and a proximal portion of the body has a second stiffness of the proximal portion less than the first stiffness. The needle also includes a sleeve extending along a length of the needle body to cover the pattern along the proximal portion.