Biopsy Device With Rotating Cutting Element and Oscillating Distal Tip
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Solution Overview
Problem
Current medical devices face challenges in efficiently penetrating and retrieving tissue samples, particularly in crossing vascular occlusions and de-bulking, with existing devices often encountering high resistance and difficulty in obtaining multiple samples during a single insertion.
Innovation Solution
A tissue biopsy device with a tubular penetration and coring assembly that minimizes resistance through tissues, featuring a cutting element with an engagement feature and a distal tip capable of rotation and oscillation, along with a rotatable element, enabling a hammer drill motion and selective beak configurations for enhanced tissue penetration and sample retrieval.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a conventional biopsy device is used for tissue penetration and sample retrieval, then the device structure is simple, but the device encounters high resistance through tissues and cannot efficiently cross vascular occlusions
Solution Approach 1:
The cutting element is configured to rotate and oscillate dynamically during tissue penetration, transforming a static cutting tool into a dynamic one that can actively engage and cut through tough tissues and vascular occlusions. This rotational and oscillating motion reduces penetration resistance by continuously refreshing the cutting edge and preventing tissue adhesion.
Solution Approach 2:
The device incorporates oscillating motion of the cutting element and distal tip, creating mechanical vibration that enhances tissue penetration efficiency. The vibration helps break up tissue bonds, reduces friction, and allows the cutting element to more effectively sever vascular occlusions and dense tissue structures.
2Quantity of substance
If a single-sample biopsy device is used, then the device structure is simple, but multiple samples cannot be obtained during a single insertion
Solution Approach 1:
The outer tube features multiple apertures positioned at different locations along its length, allowing the cutting element to retrieve multiple tissue samples sequentially during a single insertion. Each aperture can capture a separate tissue core, enabling the collection of multiple samples without requiring device reinsertion.
Solution Approach 2:
The device is designed to perform multiple functions: penetrating tissue, cutting tissue, capturing multiple samples through different apertures, and retrieving all samples in a single operation. This multi-functional design eliminates the need for separate devices or multiple insertions to obtain multiple tissue samples.
3Ease of operation
If a cutting element without engagement features is used, then the device structure is simple, but the distal tip cannot be entrained in rotation and oscillation
Solution Approach 1:
The engagement feature on the cutting element automatically engages with the distal tip during operation, causing the distal tip to be entrained in rotation and oscillation without requiring external actuation mechanisms. The cutting element's motion self-propels the distal tip, eliminating the need for separate motors or actuators at the distal end.
4Force
If a device without hammer drill motion is used, then the device structure is simple, but the device cannot effectively cross chronic total vascular occlusions
Solution Approach 1:
The device combines rotation and oscillation motions into a unified hammer drill action at the distal tip. The engagement feature transmits both rotational and oscillating motions simultaneously, creating a compounded mechanical action that delivers high impact forces for penetrating chronic total vascular occlusions while maintaining a relatively simple overall structure.
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 crosses vascular occlusions and retrieves multiple tissue samples with reduced resistance, allowing for efficient pathological analysis and compatibility with both portable and reusable configurations, including mechanical and electrical operation.
Implementation Method 1
a cutting element rotatably disposed within the outer tube and configured for movement along the longitudinal axis to cut vascular occlusive material within the aperture
Implementation Method 2
cutting element configured for rotation and movement across the aperture along the longitudinal axis... to cut at least the vascular occlusion
Implementation Method 3
the engagement feature at least partially engages the mating feature of the proximal end of the distal tip and entrains the distal tip in at least one of oscillation along the longitudinal axis and rotation
Data Source
AI summary
A device comprises an outer tube defining a longitudinal axis and comprising an aperture near a distal end thereof; a cutting element disposed within the outer tube and configured for rotation and movement across the aperture along the longitudinal axis, the cutting element comprising an engagement feature at a distal end thereof; and a distal tip comprising a tapered distal end and a proximal end that comprises a mating feature. The cutting element may be configured to rotate and cut tissue as it moves along the longitudinal axis across the aperture until the engagement feature at least partially engages the mating feature of the proximal end of the distal tip and entrains the distal tip in oscillation along the longitudinal axis and/or rotation.