Needle Tip Position Sensing for Ultrasound-Guided Biopsy
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Solution Overview
Problem
Core needle biopsy procedures face challenges in accurately estimating the spatial distances and orientation between an ultrasound probe and the needle, leading to potential piercing of critical anatomy due to oblique trajectories and difficulty in visualizing the needle tip within the ultrasound imaging plane.
Innovation Solution
A medical device with a position sensing system, including a transmitter or receiver device, is integrated to determine the position and orientation of the needle tip, using magnetic field detection, and a graphical user interface is generated to overlay the projected trajectory on ultrasound images, enabling precise needle guidance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the operator estimates spatial distances and orientation manually without position sensing, then the procedure is simpler and faster to initiate, but the accuracy of needle placement deteriorates leading to potential piercing of critical anatomy
Solution Approach 1:
The position sensing device is nested within the hollow proximal portion of the needle core, utilizing the existing structural space. This allows integration of the sensing system without adding external components that would increase device complexity, while still achieving real-time position tracking to improve measurement precision
Solution Approach 2:
The position sensing system acts as an intermediary between the operator and the needle tip, providing real-time feedback on needle position and orientation. This mediator enables the operator to make informed decisions about needle placement, improving accuracy without requiring the operator to directly estimate spatial relationships
2Adaptability or versatility
If the needle is inserted oblique to the ultrasound imaging plane to sample all regions, then the biopsy coverage is improved, but the visualization of the needle tip deteriorates making it difficult to track
Solution Approach 1:
The position sensing system provides continuous feedback on needle tip position and orientation, displayed on the ultrasound imaging system. This feedback loop allows the operator to maintain oblique trajectories for comprehensive biopsy coverage while simultaneously monitoring needle position through the sensing system, resolving the visualization difficulty
Solution Approach 2:
The position sensing system adds a new dimension of information display by providing three-dimensional position and orientation data that complements the two-dimensional ultrasound image. This allows the operator to visualize needle trajectory in multiple dimensions simultaneously, maintaining oblique approaches while improving detection capability
3Productivity
If the needle advances quickly to complete the biopsy, then the procedure efficiency is improved, but the safety deteriorates as critical anatomy may be pierced before the operator can correct course
Solution Approach 1:
The position sensing system operates continuously throughout the needle advancement process, providing uninterrupted real-time position data. This continuous monitoring allows the operator to advance the needle quickly for efficiency while maintaining constant awareness of needle position relative to critical anatomy, enabling rapid correction if needed
Solution Approach 2:
The system replaces manual mechanical estimation of needle trajectory with an automated electromagnetic sensing system. This substitution provides objective, real-time position data that complements the operator's visual assessment, allowing faster advancement while improving safety through continuous electronic monitoring rather than relying solely on manual tracking
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
Enhances the accuracy of needle placement by providing real-time positional and orientational data, reducing the risk of complications by ensuring the needle follows the intended trajectory and avoids critical anatomy.
Implementation Method 1
the device of the position sensing system is the receiver device, the receiver device comprising a magnetic field sensor configured to detect a magnetic field generated by an external transmitter device of the position sensing system, and provide a signal that indicates at least one of the position or the orientation of the distal tip based on a strength of the magnetic field detected
Data Source
Figure 1A~1B
Figure 2A~2C
Figure 2D~2F
AI summary
Medical devices are described, including a medical device that includes a handle and a needle extending distally from the handle. The needle may be configured to be at least partially inserted into a body, and may include a sheath and a core disposed in the sheath. The core may have a distal portion including a distal tip, and a proximal portion distinct from the distal portion. A proximal end of the distal portion may be coupled to a distal end of the proximal portion to define a cavity between the proximal end of the distal portion and the distal end of the proximal portion. The needle may further include a device of a position sensing system arranged in the cavity. The device may be a transmitter device or a receiver device. The position sensing system may be configured to determine a position or an orientation of the distal tip.