Soft Tissue Biopsy Device with Laser-Cut Beaks
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Solution Overview
Problem
Current fine needle aspiration systems are limited in their ability to perform minimally invasive and reliable soft tissue biopsies, particularly in retrieving solid, contiguous, and fragmented tissue samples efficiently during a single insertion.
Innovation Solution
A soft tissue biopsy device configured with a range of work element diameters, featuring a monolithic structure with laser-cut beaks and tendons for actuation, allowing for single or multiple tissue samples to be retrieved through a single insertion, and capable of being powered electrically, mechanically, hydraulically, pneumatically, or manually, with features for different phases of biopsy procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fine needle aspiration systems are used, then minimally invasive procedure is achieved, but reliability and efficiency of tissue sample retrieval is limited
Solution Approach 1:
The device is divided into distinct functional segments: an outer sheath for minimally invasive insertion, an inner coring structure for tissue sampling, and a cutting mechanism with beaks for separating the core sample. This segmentation allows each component to perform its specific function optimally while maintaining overall system reliability.
Solution Approach 2:
The inner coring structure with cutting beaks is nested within the outer sheath, allowing the complex sampling mechanism to be delivered through a small percutaneous access point. The nested configuration enables the device to maintain simplicity during insertion while providing complex functionality during tissue sampling.
2Productivity
If multiple biopsy samples are retrieved during single insertion, then productivity is improved, but device complexity increases
Solution Approach 1:
The device integrates multiple functions into a single instrument: percutaneous insertion, core sampling, tissue cutting, and sample retrieval. The universal design allows the device to perform all these functions during one insertion procedure, improving productivity without requiring multiple separate devices.
Solution Approach 2:
The cutting beaks, coring structure, and aspiration mechanism are merged into a single integrated device. This combination allows simultaneous or sequential performance of cutting and sampling functions during one insertion, enhancing productivity while managing complexity through unified design.
3Measurement precision
If larger core samples are obtained, then diagnostic capability is improved, but amount of tissue removed increases
Solution Approach 1:
The device extracts only the necessary core sample of tissue through precise cutting action of the beaks, separating the required diagnostic portion from the surrounding tissue. This extraction approach obtains sufficient sample material for diagnosis while minimizing unnecessary tissue removal.
Solution Approach 2:
The cutting beaks are designed to apply localized cutting action at the precise location where the core sample is needed. This localized approach ensures that tissue is removed only where necessary for diagnostic purposes, maintaining sample adequacy while minimizing overall tissue loss.
Data Source
AI summary
A device for soft tissue biopsy or excision for either handheld or stereotactic table use may comprise a work element configured to selectively open and close at least one articulable beak configured to penetrate tissue, or follow a central lumen of another device or over a wire in a longitudinal direction. Flush and vacuum tissue transport mechanisms may be incorporated. A single tube or an inner sheath and an outer sheath which may be co-axially disposed relative to a work element may be configured to actuate a beak or beaks and provisions for simultaneous beak closing under rotation may be incorporated.