Tissue Localization Marker with Biconvex Cross-Section
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Solution Overview
Problem
Current tissue localization methods, such as wire localization, are prone to inaccurate placement, migration, and discomfort for patients, and can lead to unnecessary tissue removal or transmission of cancer cells during breast cancer treatment.
Innovation Solution
A tissue localization device with a delivery needle and a detachable localization element that can be slidably translated within the needle, featuring an echogenic surface treatment and a tracking wire, allowing for accurate placement and secure positioning of the localization element, reducing migration risks and patient discomfort.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If wire localization is used to mark tissue, then tissue can be identified for removal, but the wire is prone to migration and inaccurate placement
Solution Approach 1:
The localization device is divided into separate components: a delivery needle that can be positioned accurately and a localization element that remains after needle removal. This segmentation allows the needle to guide placement precisely while the separate localization element stays stable in the tissue without the migration risks of a continuous wire.
Solution Approach 2:
The delivery needle is removed after positioning the localization element, extracting the guidance function from the final configuration. This allows the localization element to remain independently in the tissue without the structural constraints that cause wire migration, while still achieving accurate initial placement through the needle's guidance.
2Ease of operation
If wire localization is used, then tissue can be marked, but the surgeon cannot intraoperatively identify the wire tip
Solution Approach 1:
The localization element incorporates radiopaque material that appears bright white on fluoroscopic imaging, providing high visual contrast against surrounding tissue. This allows the surgeon to easily identify the precise location and orientation of the localization element during surgery without confusion about tip position.
Solution Approach 2:
The patent replaces mechanical wire identification methods with radiographic visualization. Instead of relying on physical wire characteristics that are difficult to see, the radiopaque material enables optical detection through imaging systems, making the localization element easily identifiable during surgery.
3Manufacturing precision
If wire localization is used, then tissue can be demarcated, but excessive tissue may be removed
Solution Approach 1:
The radiopaque material provides clear visual boundaries on imaging systems, allowing the surgeon to precisely see where the localization element marks the tissue margin. This accurate visualization enables removal of only the necessary tissue while preserving healthy surrounding tissue, reducing unnecessary loss.
4Manufacturing precision
If wire localization is used, then tissue can be marked, but the wire protrudes stiffly causing patient discomfort
Solution Approach 1:
The delivery needle is extracted after positioning, leaving only the small localization element in the tissue. This removes the long, stiff wire that protrudes from the body and causes discomfort, while maintaining the tissue marking function through the remaining localization element that can be visualized radiographically.
Solution Approach 2:
The localization element is designed as a small, flexible fragment rather than a stiff wire. This thin, flexible structure can be comfortably retained in the tissue without protruding or causing significant discomfort, while still providing adequate radiographic visualization for surgical guidance.
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 enables precise and secure marking of tissue for surgical removal, minimizing the risk of migration and discomfort, while reducing the transmission of cancer cells and allowing for flexible scheduling of surgical procedures.
Implementation Method 1
The localization element can have an echogenic surface treatment. The echogenic surface treatment can be a surface roughness, a pattern cut into a surface of the localization element, or combinations thereof.
Data Source
AI summary
Tissue localization devices and methods of localizing tissue using tissue localization devices are disclosed. The tissue localization device can comprise a handle comprising a delivery control, a delivery needle extending out from the handle, and a localization element within the delivery needle. The localization element can be deployed out of the delivery needle or retracted back into the delivery needle when the delivery control is translated in a first direction or a second direction, respectively. The localization element can be coupled to a flexible tracking wire.