Mammary Immobilization Device for Breast Screening Applications
The prospects of curing breast cancer are directly related to the time of detecting the disease. Diagnostic methods of this kind often indicate the need for an immobilization of the mamma for the period of the examination, for example in breast cancer screening by carrying out a stereotactic mammography.
For a qualitative assessment, the mamma will usually be compressed by parallel-oriented components under applied pressure. The degree of applied pressure mainly depends on the imaging method, the mamma size and shape, and the tissue density level. Patient studies estimate that up to 46% of all women refrain from participating in a second screening or break off such a mammogram due to the high compression pain.
Moreover, in most cases an inhomogeneous compression level occurs over the tissue volume that can lead to drastic misinterpretations and consequently to psychological stress and life-threatening wrong medical decisions.
Therefore, the invention provides a breast immobilization device that reduces the method- and equipment-induced grade of inhomogeneity of tissue compression by 62% as compared to conventional immobilization with parallel grid- or plate devices and regardless of mamma size and tissue density level.
This is carried out by a specifically developed mamma support component in combination with a flexible element that wraps around the mamma while compressing it at the same time. The execution is carried out manually by medical staff.
The reduction of the equipment-induced compression pain by 31% leads to a better acceptance of the diagnostic method in affected patients.
The system mainly focuses on mamma cancer screening like X-ray mammography and secondary examination methods, like MRI-biopsy. However, the invention can generally be adapted to all kinds of examination where soft tissue has to be immobilized using compression. The use of special sorted materials and shapes based on validated biomedical modeling leads to a usability for X-ray, MRI and Sonographie Systems.
- No equipment-induced compression pain
- Usable for all breast sizes
- Compatible with all medical imaging systems (X-Ray, MRI, Sono)
- Intuitive user interaction
Prototypes for various applications and systems have been tested and evaluated. The modular engineering approach leads to an “easy to adapt” component-system.
Patent EP2480134B1, validated in DE
Kower, O., “Automatisierte Vakuumbiospie der Mamma im Isozentrum des MRT – ein Systementwurf mittels Set-Based Concurrent Engineering”, PhD-These, University Duisburg-Essen 2015