Biopsy Needle Actuator Assembly for Prostate Mapping
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Solution Overview
Problem
Current transrectal ultrasound-guided prostate biopsy methods are inefficient in accurately identifying and sampling prostate cancer lesions, particularly for low-risk cancers, leading to inconclusive results and unnecessary treatments, as they rely on a 'blind' approach and struggle with visualizing smaller lesions.
Innovation Solution
A transperineal prostate needle biopsy system with a biopsy needle actuator device that includes a counter assembly for precise movement registration and a three-dimensional tissue mapping system for planning and guiding biopsies, allowing for targeted tissue sampling and improved accuracy in lesion identification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Illumination intensity
If transrectal ultrasound-guided biopsy is used, then real-time imaging of prostate gland is achieved, but visualization of smaller prostate cancer lesions is unlikely
Solution Approach 1:
The patent introduces a transperineal approach as an intermediary method between ultrasound imaging and tissue sampling. This approach uses a template-guided system with numbered sampling sites that correlates with ultrasound images, allowing precise targeting of small lesions without relying solely on real-time ultrasound visualization during the biopsy procedure itself.
Solution Approach 2:
The system performs preliminary mapping and planning before the actual biopsy. A template is placed on the perineum with predetermined sampling sites that are planned based on ultrasound imaging performed beforehand. This allows the operator to identify small lesions during the planning phase and target them accurately during the biopsy procedure.
2Productivity
If multiple individual biopsies are taken in a semi-blind approach, then lateral regions of the gland are sampled, but inconclusive results are obtained
Solution Approach 1:
The prostate gland is segmented into multiple discrete sampling sites arranged in a systematic pattern on the template. Each site is numbered and corresponds to a specific region of the prostate, allowing methodical sampling of different zones including lateral regions. This segmentation ensures comprehensive coverage while maintaining organization and trackability of each sample.
Solution Approach 2:
The system incorporates feedback by correlating each biopsy sample with its specific template site number and corresponding location on the ultrasound images. This allows the operator to review which areas have been sampled and which remain, enabling adaptive planning to target suspicious areas that may have been missed, thereby improving diagnostic accuracy.
3Reliability
If transrectal biopsy is followed by radical prostatectomy, then cancer diagnosis is confirmed, but pathology prediction is not representative of final specimen in 50-75% of situations
Solution Approach 1:
The patent transitions from a one-dimensional transrectal approach to a two-dimensional transperineal template system. The template provides a top-down view of the prostate with multiple sampling sites distributed across different zones, enabling sampling of lateral and basal regions that are difficult to reach with transrectal biopsy. This dimensional change allows more representative sampling of the entire prostate gland.
Solution Approach 2:
The template system allows different sampling strategies for different regions of the prostate. Lateral regions, basal regions, and other specific zones can be targeted with appropriate needle orientations and depths. This localized approach ensures that each region is sampled appropriately, improving the representativeness of the final pathology compared to the uniform transrectal approach.
4Adaptability or versatility
If low-risk cancers are identified on biopsy, then treatment candidates are narrowed, but accurate identification for focal therapy is extraordinarily difficult
Solution Approach 1:
The system performs preliminary mapping and characterization of all sampling sites before determining treatment strategy. Each biopsy sample is processed and evaluated, and the results are mapped back to the template to identify the precise location and extent of any cancerous lesions. This preliminary characterization enables accurate determination of whether a patient is a candidate for focal therapy versus other treatments.
Solution Approach 2:
The template creates a physical map or copy of the prostate's surface anatomy and sampling locations. This template map can be used to plan focal therapy by showing the exact locations of cancerous lesions relative to the prostate's surface landmarks. The template serves as a guide for both diagnosis and subsequent treatment planning, ensuring accurate localization for focal interventions.
Data Source
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Figure 3A~3C
Figure 3D~3E
AI summary
The system includes a biopsy needle assembly (100) for excising a tissue specimen, and includes a mandrel (102) with a core bed (116) forming a projection (122) for marking the specimen. The projection can include a marking agent for marking the specimen. An actuator assembly (200) used with needle assembly (100) includes a counter assembly (352) identifying the biopsy specimen during a procedure, and tracking the cumulative biopsies taken with the actuator. A three-dimensional biopsy mapping and focal therapy system (1102) uses an imaging system to generate and store a three-dimensional image (1472) of a target tissue. Biopsy site location and needle orientation are generated and stored with the three-dimensional image. Lesion sites of the biopsied tissue specimens are recorded with the three-dimensional image. Tumor volume is calculated and represented with the three-dimensional image. The three dimensional image is used to provide localized therapy to the diseased tissue.