Vacuum-Assisted Biopsy Needle for Larger Soft Tissue Samples
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Solution Overview
Problem
Existing biopsy devices struggle to obtain a tissue sample of adequate size from soft tissue lesions efficiently, particularly in locations like the breast, liver, lung, kidney, spleen, and prostate, as they often fail to ensure the sample is of a minimum size necessary for accurate lesion typing.
Innovation Solution
A biopsy device with a stylet and outer cannula configuration, utilizing a vacuum member to draw tissue into a sample notch and an actuating mechanism to sequentially displace the cannula for severing, allowing for controlled tissue sampling with adjustable penetration depth and vacuum-assisted sample enlargement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a conventional biopsy device is used to obtain tissue samples, then the procedure can be performed with simple equipment, but the tissue sample size is insufficient for accurate lesion typing
Solution Approach 1:
The patent employs a vacuum system with a vacuum source, vacuum line, and vacuum valve to create negative pressure that draws tissue into the biopsy needle. This pneumatic mechanism enables adequate tissue sample acquisition without requiring complex mechanical sampling systems, thus resolving the contradiction between obtaining sufficient tissue and maintaining device simplicity.
Solution Approach 2:
The device incorporates an adjustable stop member that allows modification of the penetration depth parameter. This enables optimization of the sampling depth to ensure adequate tissue retrieval while maintaining a relatively simple overall device structure, addressing the contradiction between sample quantity and device complexity.
2Quantity of substance
If the biopsy needle penetrates deeper to reach the lesion, then adequate tissue can be sampled, but the impact noise and tissue damage increase
Solution Approach 1:
The adjustable stop member is positioned in advance to define the optimal penetration depth before the biopsy procedure. This preliminary setting ensures that the needle penetrates only as deep as necessary to reach the lesion and obtain adequate tissue, thereby minimizing excessive impact noise and tissue damage while still achieving sufficient sample size.
Solution Approach 2:
The vacuum system creates negative pressure that actively draws tissue into the needle during penetration. This pneumatic assistance reduces the mechanical impact force required for tissue retrieval, thereby reducing impact noise and tissue damage while still achieving adequate sample size through the vacuum-assisted sampling mechanism.
3Force
If a vacuum system is added to assist tissue sampling, then adequate tissue can be obtained with less force, but the device complexity increases
Solution Approach 1:
The vacuum system comprises a vacuum source, vacuum line, and vacuum valve that work together to generate negative pressure for tissue sampling. This pneumatic mechanism reduces the mechanical force required for tissue retrieval, and while it adds some device complexity, the system remains relatively simple and manageable, thus providing a reasonable balance between reduced sampling force and device complexity.
Solution Approach 2:
The vacuum system is integrated into the existing biopsy device architecture, serving multiple functions including tissue sampling, sample retention, and potential hemostasis. This multi-functionality justifies the added complexity by providing additional capabilities within a single device, thereby reducing the need for separate instruments and procedures.
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 obtains a larger tissue sample by vacuum-assisted means, ensuring sufficient sample size for accurate lesion typing, with adjustable depth control and reduced impact noise during operation.
Implementation Method 1
A vacuum member in fluid communication with the sample notch is configured to generate a vacuum when the stylet is displaced by the actuator
Implementation Method 2
utilizing a vacuum member to draw tissue into a sample notch
Data Source
AI summary
Devices and methods used to obtain a tissue sample utilizing a vacuum assist are disclosed. The devices include a handle, an inner cannula, and an outer cannula. The devices include a vacuum tube in communication with a sample notch of the inner cannula. The handle is actuated to drive the inner cannula into a lesion such that the sample notch is disposed within the lesion. A vacuum is generated in the vacuum tube and the sample notch as the stylet is driven into the lesion. A tissue sample is sucked into the sample notch and the outer cannula is displaced over the sample notch to sever the tissue sample from the lesion.