Flexible Graduated Hook-Wire for Stable Breast Tumor Localization
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Solution Overview
Problem
Existing hook-wires for tumor localization in breast tissue suffer from displacement and inaccurate targeting due to deformation of the breast during surgery, leading to increased resected tissue volume and risk of incomplete excision, especially in non-palpable tumors and lymph nodes.
Innovation Solution
A hook-wire with twisted flexible metal wires forming hooks and a deformable sheathing with graduated indicia, allowing precise anchoring and depth measurement, ensuring accurate tumor localization despite breast movement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional hooks are used for tumor localization, then the hook can be placed to mark the tumor location, but the breast deformation during surgery causes displacement of the hook and inaccurate targeting
Solution Approach 1:
The hook-wire is divided into multiple segments: a rigid hook portion for anchoring, a flexible intermediate portion for navigation, and a graduated scale portion for measurement. This segmentation allows each part to perform its specific function optimally while maintaining overall reliability.
Solution Approach 2:
The hook-wire incorporates a graduated scale with indicia that provides measurement information along its length. By changing the parameter of measurement visibility and providing depth information, the system compensates for breast deformation and maintains accurate tumor localization despite positional changes during surgery.
2Ease of operation
If the skin is peeled off during surgery to access the tumor, then the surgeon can perform the lumpectomy, but this deforms the breast and disrupts the distance measurement from the radiologist
Solution Approach 1:
The hook-wire acts as an intermediary between the radiologist's pre-surgical measurements and the surgeon's intra-surgical needs. The graduated scale on the hook-wire provides a physical reference that maintains the distance measurement relationship even when the breast is deformed during surgery, eliminating the need for real-time measurement adjustment.
3Measurement precision
If hooks are used to target non-palpable tumors, then early-stage tumors can be localized, but the hooks have difficulty anchoring in the axillary cavity fat tissue
Solution Approach 1:
The hook portion of the hook-wire is designed with specific local qualities: it is made of radiopaque material for visibility, has a curved configuration for engagement with tissue, and is positioned at the distal end for optimal anchoring. This localized optimization enables reliable anchoring in fat tissue while maintaining overall wire flexibility.
4Ease of operation
If the patient's position is changed during surgery, then the surgeon can access the tumor, but the hook direction changes and the exact distance to the tumor becomes difficult to determine
Solution Approach 1:
The graduated scale with indicia is placed on the hook-wire before surgery, allowing the radiologist to mark the tumor location and depth in advance. This preliminary measurement information is encoded on the hook-wire and remains with it through position changes, eliminating the need for real-time distance determination during surgery.
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 precise tumor localization, reducing resected tissue volume and improving aesthetic outcomes by maintaining anchor position and facilitating easy depth determination during surgery.
Implementation Method 1
the at least two wires are flexible, i.e. can bend and/or fold easily along a total length of the hook-wire
Data Source
Figure 1~5
Figure 6~7
AI summary
The invention relates to a hook-wire (24) for localization of a tumor (32) in a breast (30), comprising: an elongate member with a proximal end and a distal end; at least one hook (8) at the distal end of the elongate member, configured for insertion in a constrained state into a needle and expansion when exiting said needle in order to anchor the tumor in said breast; wherein the elongate member and the at least one hook are formed by at least two metal wires (2) which are twisted around each other continuously from the proximal end to the distal end and terminating each at said distal end with a free curved portion forming one the at least one hook. The invention also relates to a kit comprising the hook- wire of the invention, the needle, a ruler, and a guide element being configured to slide coaxially inside the needle.