Biopsy Device Rigid Protrusions for Endothelial Cell Sampling
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Solution Overview
Problem
Existing biopsy devices for sampling endothelial cells from blood vessels and lymphatic vessels are invasive and fail to capture sufficient cell samples, risking tissue damage and variability in sample yield.
Innovation Solution
A minimally invasive biopsy device with a tubular member and an elongated member featuring a distal portion with a plurality of rigid protrusions, designed to maximize sample yield while minimizing tissue damage, using a superelastic material and additive manufacturing for precise construction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If traditional guidewires, stents or coils are used for endothelial cell sampling, then the device can be navigated inside vessels, but the sampling amount varies highly and insufficient cells are captured
Solution Approach 1:
The distal portion of the elongated member is segmented into multiple rigid protrusions distributed across its surface. This segmentation increases the total surface area available for cell capture and ensures more consistent sampling by distributing the capture function across multiple discrete elements rather than relying on a single capture mechanism.
Solution Approach 2:
The invention transitions from traditional one-dimensional wire-based devices to a three-dimensional structure with protrusions extending radially from the elongated member. This dimensional change creates multiple capture points at different spatial positions, significantly increasing the quantity and consistency of cells that can be captured during a single sampling event.
2Quantity of substance
If brush elements are expanded into the pulmonary vasculature for cell sampling, then endothelial cells can be obtained, but the vasculature is injured during expansion
Solution Approach 1:
The device employs a dynamic configuration where the elongated member can be advanced relative to the tubular member to deploy the protrusions only when needed for sampling. During navigation, the protrusions remain retracted within the tubular member, minimizing interaction with the vasculature. During sampling, the protrusions are deployed to capture cells, then retracted to minimize damage during withdrawal.
Solution Approach 2:
The rigid protrusions are designed to rapidly engage the vessel wall during a brief sampling moment and then be quickly retracted. This rapid engage-and-disengage mechanism minimizes the duration of tissue interaction, reducing overall tissue damage while still achieving sufficient cell capture during the brief contact period.
3Quantity of substance
If the elongated member is made expandable to increase sample capture area, then more cells can be sampled, but the device complexity increases
Solution Approach 1:
Instead of making the entire elongated member expandable, the invention extracts only the necessary functional elements (the rigid protrusions) and places them on the distal portion. This localized approach increases sample capture area where needed while keeping the rest of the device simple and non-expandable, maintaining ease of navigation and deployment.
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 achieves high precision and increased sample yield with reduced tissue damage by effectively scraping the vessel wall with rigid protrusions, allowing for efficient endothelial cell sampling without expanding the vasculature.
Implementation Method 1
an elongated member movably arranged within the lumen of the tubular member
Implementation Method 2
effectively scraping the vessel wall with rigid protrusions
Data Source
AI summary
A biopsy device for sampling cells or tissue in a subject, the biopsy device comprising: a tubular member defining a lumen; and an elongated member movably arranged within the lumen of the tubular member, wherein a distal portion of the elongated member comprises a tissue capture arrangement including a plurality of rigid protrusions.