Coring Tissue Biopsy Needle with Depth Control
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Solution Overview
Problem
Current biopsy devices are inefficient in collecting accurate, sufficiently-sized tissue samples with minimal damage to surrounding tissue, often requiring multiple entries, causing trauma, pain, and increasing the risk of contamination and infection.
Innovation Solution
A biopsy device featuring an entry needle and a coring cannula that can be simultaneously rotated and axially reciprocated over the needle, allowing for precise collection and ejection of tissue samples with minimal trauma and reduced contamination risk, utilizing a handle mechanism for controlled deployment and sample ejection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single-ported biopsy device is used, then the device structure is simple, but only a single sample can be captured per entry requiring multiple entries to collect sufficient tissue
Solution Approach 1:
The biopsy device is divided into multiple independently operable ports, each capable of capturing tissue samples. This segmentation allows simultaneous or sequential sample collection through multiple ports without requiring device repositioning, thereby increasing productivity while maintaining reasonable structural complexity
Solution Approach 2:
Each port on the biopsy device is designed with universal functionality to capture tissue samples independently. The multiple ports serve the same sampling function, allowing the device to collect multiple samples in a single entry, thus improving productivity without proportionally increasing device complexity
2Ease of operation
If manual force is applied to drive the collection device into tissue, then the device can penetrate the tissue, but unnecessary pain is caused to the patient
Solution Approach 1:
The biopsy device incorporates curved or beveled edges on the coring needle and entry needle, allowing the device to penetrate tissue more smoothly by distributing the penetration force over a curved surface rather than a sharp point. This reduces trauma and patient pain while maintaining the ability to penetrate tissue effectively
Solution Approach 2:
The device utilizes spring-loaded mechanisms that control the delivery and retrieval forces applied to the tissue. By changing the force parameters through controlled spring expansion and compression, the device achieves effective tissue penetration while minimizing excessive force that would cause patient pain
3Ease of operation
If the collection device rips or tears the sample from its original dwelling, then the sample can be removed, but unnecessary trauma is caused to the surrounding tissue
Solution Approach 1:
The coring needle features a curved or beveled leading edge that allows it to bore into and retrieve tissue samples by cutting rather than ripping. This curved geometry enables the needle to advance through tissue and capture samples with minimal disruption to surrounding tissue architecture, reducing trauma while maintaining sample removal capability
Solution Approach 2:
The device replaces manual ripping or tearing motions with a controlled rotational boring mechanism. The coring needle rotates as it advances through tissue, cutting a clean core sample rather than ripping tissue apart. This mechanical substitution reduces trauma to surrounding tissue while effectively removing the sample
4Device complexity
If the biopsy device fails to accurately disclose depth, then the device structure is simple, but multiple entries are required to collect sufficient sample
Solution Approach 1:
The biopsy device incorporates depth indicators or measurement markings that provide real-time feedback to the operator about the penetration depth during the biopsy procedure. This feedback mechanism allows the operator to monitor and control the sampling depth accurately, ensuring sufficient sample collection in a single entry without requiring complex additional components
Solution Approach 2:
The device includes pre-set depth stoppers or limiting mechanisms that prevent the needle from penetrating beyond a predetermined depth. This preliminary action ensures that the needle reaches the appropriate tissue depth for sampling without requiring complex real-time measurement systems, maintaining sample collection efficiency while minimizing device complexity
5Quantity of substance
If multiple entries are performed to collect sufficient sample, then adequate tissue can be obtained, but increased risk of contamination and infection occurs
Solution Approach 1:
The biopsy device features multiple ports that can capture tissue samples simultaneously or in sequence during a single entry. This segmentation of the sampling function across multiple ports allows adequate tissue quantity to be obtained without requiring multiple puncture entries, thereby reducing the opportunity for contamination and infection at each entry site
Solution Approach 2:
The device incorporates sealed sample chambers or containment mechanisms that prevent sample contamination after collection. By properly containing and protecting the collected tissue samples within the device structure, the risk of contamination during the procedure is minimized, allowing adequate sample collection in a single entry without compromising reliability
6Manufacturing precision
If a sharpened coring cannula is used, then tissue sampling precision is improved, but device complexity increases
Solution Approach 1:
The coring cannula is equipped with a sharpened beveled edge or curved cutting surface that enables precise tissue sampling through a boring action. This geometric feature is integrated directly into the cannula structure during manufacturing, achieving high sampling precision without requiring complex adjustable or multi-component mechanisms
Data Source
AI summary
Biopsy devices and methods are provided for collecting a sufficiently-sized tissue sample from a region at a known distance by boring into the sample region using simultaneous axial and rotational movement and providing a reduced risk of: over-passing or under-passing the sample sought, injury and trauma to the surrounding tissue area, having to stick the patient more than once, sample contamination, and the user's exposure to sharps.