X-ray based low-radiation thyroidography device

Technical Field:

The invention relates to a novel x-ray based low-radiation diagnosis/differential diagnosis device intended for enabling the diagnosis of the thyroid diseases, in particular the malign diseases, with a higher reliability as compared to the current standard diagnostic methods as well as enabling the differential diagnosis to be made with higher reliability, thereby enabling a reduction in the unnecessary thyroid surgeries and interventional procedures for thyroid on the one hand and enabling the early diagnosis for the diseases on the other hand.

State of the Art: The thyroid gland is a butterfly- shaped organ, which is situated in the anterior (front) part of the neck at a lower aligned position with respect to the throat and which circumvents the trachea by about 180 degrees. Both benign and malign thyroid diseases are quite frequently encountered in the thyroid gland. At the present, the goiter disease and the thyroid nodule are the most commonly encountered diseases among the benign thyroid diseases. The goiter disease, defined as the enlargement of the thyroid gland, is encountered in about 1/2 of the normal population at over 40 years of age, while the thyroid nodule is encountered in about 1/3 of the same. The most frequently observed malign disease for the thyroid includes the cancers and these are the malign diseases with the highest rate of increase in incidence among the world's female population. Both benign and malign thyroid diseases occur much more commonly in the endemic goiter countries such as Turkey. Today, the ultrasonography (USG) is the most commonly employed radiological diagnosis/differential diagnosis method for the diagnosis of the thyroid diseases with highest sensitivity and specificity. The other radiological methods, which are rarely employed other than the specific circumstances, include the computerized tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) and thyroid scintigraphy. Despite its superiority over the other methods, the sensitivity of the ultrasonography for the diagnosis of the malign thyroid diseases is around 70%.

Consequently, a novel technology is needed, which is capable of overcoming the aforesaid disadvantages and which enables the sensitivity for the diagnosis of the malign thyroid diseases to be increased to 90% and above. Description of the Invention:

This invention is a novel x-ray based low -radiation diagnosis/differential diagnosis device capable of overcoming the aforesaid disadvantages, said device being characterized in that it comprises, in addition to the basic parts available in a mammography device, the concave surfaces for being contacted with the neck from both sides and for fixing the neck region with a certain pressure, a detector plate resting stationary on one of these surfaces, a movable compression plate on the other surface, made from a material that would not hinder the passage of the x-rays, and a DICOM-3 compatible interface for enabling the x-rays incident on the detector plate to be transferred directly to the digital system and the generation of an image on the screen without data loss as well as for enabling these obtained images to be easily archived and shared in the digital system.

The thyroid tissue and the breast tissue are similar in many respects. Both are endocrine organs and the ultrasonography is valuable in the diagnosis of the malign diseases of both, but the breast diseases benefit from the advantage that the mammographic examination is available in addition to the ultrasonography. The mammography alone has a diagnostic sensitivity of around 80% for the malign breast diseases and said sensitivity reaches around 90% when the mammography is combined with the ultrasonography.

The mammography is an x-ray based radiological imaging technique, which differs from the other radiological techniques in that it compresses and fixes the breast between two surfaces, it applies low radiation dose and provides high resolution images (films). The x-ray based low-radiation thyroidography device according to the invention has been developed with the prediction that it could contribute to the diagnosis of the thyroid diseases in a manner similar to the diagnostic contribution the mammography provides for the breast diseases.

Description of the Figures: The invention will be described with reference to the enclosed drawings, and in this way, the features of the invention will be more clearly understood and appreciated. However, it is not intended herein to limit the invention to these particular embodiments disclosed. On the contrary, the invention is intended to encompass all the alternatives, variations and equivalents thereof that are possible to be included within the scope of the invention as defined in the appended claims. It should be understood that the illustrated details are shown only for the purpose of describing the preferred embodiments of the present invention and that they are presented in order to provide the most convenient and most readily understandable description for the formation of the methods as well as the principles and conceptual features of the invention. In said drawings;

Figure 1: The compressed state of the apparatus for adjusting the width between the plates and ensuring the stabilization of the plates

Figure 2: The open state of the apparatus for adjusting the width between the plates and ensuring the stabilization of the plates

Figure 3: A close-up view of the detector plate and the movable compression plate

Figure 4: A view of application of the x-ray based low radiation thyroidography device to a patient

Figure 5: A view of application of the x-ray based low radiation thyroidography device to a patient

Figure 6: Obtaining of the images during the filming

Figure 7: Evaluation of the obtained images in the workstation and implementation of the postprocessing procedures (tasks performed by means of the software programs on the obtained images)

The parts in the figures, which are provided to assist in understanding the invention, are assigned with reference numerals as indicated in the enclosed drawings wherein said reference numerals have the following designations: Description of the Reference Numerals:

1. Apparatus for adjusting the width between the plates and ensuring the stabilization of the plates

2. Movable compression plate

3. Detector plate 4. X-ray tube

5. Movable and flexible arm

6. Main body 7. Center for changing the angle of the x-ray tube

8. Filming console

9. Intermediate cable

10. Workstation

Detailed Description of the Invention:

The main components of the invention comprise the members available in a mammography device. These are an x-ray tube, a generator for regulating the voltage of the mains power, a transformer and a computer system for processing the obtained images. The novel compartment, which we have designed in addition to these main parts, is as follows:

Two concave surfaces, which are designed in a way to be compatible with the human neck anatomy and which have a height enabling them to fit above the clavicles at the bottom and below the mandibula at the top, are coupled with the main body (6) via the arms (5). The concave surfaces are to be brought into contact with the neck from both sides and fix the neck region with a certain pressure. A detector plate (3) is disposed in a stationary manner on one of these surfaces, while a movable compression plate (2), made from a material that would not hinder the passage of the x-rays, is disposed on the other surface. The surfaces are designed to have the ability of displacement to obtain separate images from the right and left sides so that it would be possible to obtain the images of the neck region, which contains the thyroid, from both sides. Although the digital system employed in the invention is automatically programmed for applying the appropriate dose of x-rays according to the tissue thickness, it will also allow the kV and mAs values to be adjusted manually from the control console in cases necessary. In case of necessity, it will be possible to mount a stereotactic procedure apparatus to the device. The secondary radiation will be prevented by means of an appropriate grid system in front of the digital detector system, which is to detect the x-rays penetrating the tissue, and the image quality will thus be improved. The x-rays incident on the detector plate (3) will be transferred directly to the digital system to enable the generation of an image on the screen, and in this way, it will be possible to obtain the image without any data loss. Owing to the DICOM-3 compatible interface, it will be possible to easily archive and share these obtained images in the digital system. The computer system to which the device is connected features the ability to allow the loading of the additional protocols such as tomosynthesis. The obtained images will be processed in the workstation (10), in which the images are assessed by a radiologist and the postprocessing procedures (tasks performed by means of the software programs on the obtained images) are performed by the use of the software, said software being designed to be compatible with the histological, histopathological and radiological images of the thyroid tissue and the disease in said tissue in the computer environment, thereby offering various images for the clinician.

These images will be used in the diagnosis and differential diagnosis of the thyroid diseases initially with the known radiological diagnosis parameters and subsequently with the new technologies and/or parameters that could be developed based on the information gathered with increasing imaging experience.