Flexible Brush Biopsy Device for Cyst Sampling

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Solution Overview

Problem

Current methods for diagnosing pancreatic cysts, such as EUS-FNA, face challenges due to the scarcity of cells in cystic fluid, leading to inconclusive diagnoses and risks of tissue damage.

Innovation Solution

A minimally invasive biopsy/cytology device with a flexible member that transitions from a constrained to an expanded configuration within a needle or catheter, allowing for gentle scraping of cells from the cystic lining without causing significant tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If EUS-FNA is used to sample cystic lesions, then the procedure is minimally invasive, but the cell content in the sample is scarce leading to inconclusive diagnoses

Engineering Contradiction:
Improvetissue damageVSAvoidcell content
Core Design Contradiction:
Object-affected harmful factorsVSQuantity of substance

Solution Approach 1:

The brush element transitions from a compressed low-profile configuration during insertion to an expanded working configuration inside the cyst, allowing the same component to serve multiple functions at different stages of the procedure

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The brush element comprises a flexible structure with bristles that can conform to the cyst wall surface, maximizing contact area for cell collection while maintaining a compact form during insertion

Inventive Principle:
Principle #30Flexible shells and thin films

2Quantity of substance

If a spiral shaped distal end is used to maximize contact area, then cell harvesting is improved, but the device may break during operation and retraction

Engineering Contradiction:
Improvecell harvestingVSAvoiddevice integrity
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The brush element dynamically changes its configuration from compressed to expanded, allowing it to achieve maximum contact area only when needed inside the cyst, while maintaining structural integrity during insertion and retraction

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The brush element is nested within the elongated member during insertion, and the elongated member is nested within the catheter, creating a hierarchical nesting structure that protects vulnerable components

Inventive Principle:
Principle #7Nested doll (Nesting)

3Reliability

If the whole length of the flexible shaft is made from Nitinol, then flexibility and durability are improved, but manufacturing cost increases

Engineering Contradiction:
Improveflexibility and durabilityVSAvoidmanufacturing cost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

Different segments of the device have different material compositions - the brush element and elongated member use Nitinol for flexibility, while the catheter uses less expensive materials, optimizing both performance and cost

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The device is divided into separate functional segments (catheter, elongated member, brush element) that can be manufactured using different materials and processes, allowing cost optimization for each component

Inventive Principle:
Principle #1Segmentation

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 device effectively increases the number of harvested cells, improving diagnostic accuracy while minimizing tissue damage and the risk of complications.

Implementation Method 1

The flexible member has a first, constrained configuration within the lumen of the needle or catheter and, following advancement of the elongated member in the needle or catheter, the flexible member has a second, expanded configuration outside said lumen

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentUS20250025142A1Biopsy/cytology device and method for sampling cells or tissue in mammals
Publication Date: 2025.01.23 LUCKY LOOP MEDICAL AB
  • US20250025142A1 patent drawing
  • US20250025142A1 patent drawing
  • US20250025142A1 patent drawing

AI summary

A device and technique for detaching cells or tissue from a cavity in a subject including an elongated member arranged to be moved within a lumen of a needle or a catheter. The device further includes at least one flexible member arranged at a distal end of the elongated member. The flexible member is configured to be brought between a first, constrained configuration within the lumen of the needle or catheter, and a second, expanded configuration outside said lumen. The flexible member in the second, expanded configuration is configured to conform to an inner geometry of a cavity in which the device is inserted.