Biopsy Needle Position Sensing for Real-Time Tip Orientation
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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, comprising a transmitter or receiver device, is integrated into the needle, allowing for real-time tracking of the needle's position and orientation using electromagnetic tracking, which is fused with ultrasound imaging to generate a graphical user interface for guiding the needle's trajectory.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If electromagnetic tracking is integrated into the needle, then measurement precision of needle position and orientation is improved, but device complexity increases
Solution Approach 1:
The electromagnetic tracking device is nested within the hollow cavity of the needle core, utilizing the existing internal space of the needle structure. This allows integration of the sensing system without significantly increasing the external dimensions or overall complexity of the needle assembly.
Solution Approach 2:
The needle core serves multiple functions: it provides structural support, contains the electromagnetic tracking device, and maintains the biopsy tissue sample. By making the core multi-functional, the patent reduces the need for separate components, thereby managing device complexity while achieving precise tracking.
2Reliability
If real-time position tracking is implemented, then reliability of biopsy procedure is improved, but device complexity increases
Solution Approach 1:
The electromagnetic tracking system provides real-time feedback on needle position and orientation during the biopsy procedure. This feedback is displayed on a graphical user interface, allowing the operator to continuously monitor and adjust the needle trajectory, thereby improving procedure reliability and safety.
Solution Approach 2:
The patent introduces an intermediary computing device that processes raw electromagnetic tracking data and presents it in a simplified graphical format. This intermediary layer shields the operator from the complexity of the underlying sensing system while providing reliable position information.
3Manufacturing precision
If the needle core is made hollow to accommodate sensing device, then manufacturing precision is improved, but strength of needle structure may worsen
Solution Approach 1:
The needle core is constructed using composite materials that provide both structural strength and the necessary mechanical properties for housing the electromagnetic tracking device. The composite structure allows for a hollow cavity while maintaining adequate strength for the biopsy procedure.
Solution Approach 2:
The needle is divided into distinct segments including the core, sheath, and electromagnetic tracking device. This segmentation allows each component to be optimized independently - the core for housing the sensor, the sheath for structural support and tissue sampling, and the tracking device for position monitoring.
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 visualization of the needle's trajectory, reducing the risk of piercing critical anatomy and improving the safety of biopsy procedures.
Implementation Method 1
A position sensing system is integrated into the needle and includes a device, such as a transmitter device or a receiver device, that enables electromagnetic tracking of the distal tip of the core
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.