FIELD OF INVENTION

The present invention relates to the field of imaging devices for detection of breast cancer. More particularly it relates to a novel imaging device with simultaneous digital X-Ray and infrared image acquisition and processing system in conjunction with a positioning apparatus for minimal radiation to the patient thereby providing an enhanced solution for breast imaging

BACKGROUND OF INVENTION

Breast cancer is the commonest form of cancer in women worldwide. It is one of the leading causes of death in most of the countries. Especially in India, It is evident from the various statistics that the breast cancer accounts for about 25% to 33% of all cancers in women. However, if breast cancer is detected at an early stage, then average five year survival rates can exceed or better.

Breast cancer screening refers to the medical screening of asymptomatic, apparently healthy women for breast cancer in an attempt to achieve an earlier diagnosis. The assumption is that early detection will improve outcomes. A number of screening test have been employed including: clinical and self breast exams, mammography, genetic screening, ultrasound, and magnetic resonance imaging.

The commonly used method is X-Ray Mammography. One another method uses ultrasound imaging systems, one another method is MRI imaging and finally the most evolving method is Thermography i.e thermal imaging of breast.

Though X-Ray based mammography is considered as a gold standard tool for breast cancer available today, most women feel discomfort during the procedure. Each breast is compressed with the help of a compression paddle and since in women, breast is two to three times more sensitive, this causes acute discomfort to the patient. Nearly Five percent to 15 percent of mammograms require follow-up testing but because of the discomfort caused by compression, a sizeable percentage of patients do not turn up for follow-up procedures. Besides discomfort, another drawback of mammography is false negative and false positive results due to Compression of three dimensional breast organs to two dimensional film or image, thereby leading to different interpretations.

The second widely used technique, Ultrasound mammography also has unique advantages but it lacks repeatability & reproducibility as the compression pressure applied by the sonologist during imaging is not tracked and hence it is difficult to reproduce. Secondly it is difficult to position suspected spot, which is identified in the initial study, in follow-up procedure. Ultrasound waves penetration in dense breast is also a matter of concern.

The other used screening method is Magnetic resonance imaging (MRI) which has shown to detect cancers not visible on mammograms. However, breast MRI has long been regarded to have disadvantages. For example, although it is 27-36% more sensitive, it has been claimed to be less specific than mammography. As a result, MRI studies may have more false positives (up to 30%), which may have undesirable financial and psychological costs. MRI based study requires very expensive MRI scanners and also a coil specific for breast positioning.

Further, an MRI may not be used for screening patients with a pacemaker or breast reconstruction patients with a tissue expander due to the presence of metal.Thereby very few procedures are performed under MRI scanners.

The most evolving method, Thermography commonly called as infrared thermal imaging uses highly specialized infra red cameras to measure the heat coming from the surface of the breast tissue. The thermal pattern of the patient's breast is collected with the help of the infrared camera in a non contact method. The human body dissipates heat through the skin to maintain itself in a thermal equilibrium. The quantity of heat is based on environment and also the exposure of skin to that environment. Tissues tend to expend more energy when they multiply and they are usually accompanied by increased blood supply by development of new vessels (angiogenesis). Tumour cells in general may have increased blood supply and also development of additional vessels (angiogenesis), as well as an increased metabolic rate, which in turn translates into increased temperature gradients compared to surrounding normal tissue. Detecting these infrared "hotspots" and gradients can thereby help to identify and diagnose tissue heat pattern thereby leading to a conclusion regarding normal or abnormal growth of tissues in a specific area.

Breast Thermography when done in a controlled and repeatable environment has provided very accurate results, but only in the hands of trained personnel using the correct type of Thermography cameras. Today's infrared cameras are capable of sensing changes in temperature at .08°C or better and do not require any patient contact. But in most of the existing Thermography procedure, images are captured in patient standing or sitting position with the breast(s) facing the thermal camera (frontal view). A single image or series of images are taken and they are compared. The fundamental flaw in such an approach is that the rest of the body also emanates heat and there is a possibility that this can (will) alter or influence the environment regarding heat pattern. Few Thermography techniques do captures heat patterns of breast in patient lying in prone position but do not capture all the views of the breast in a direct manner.

All of the above screening techniques provide either Physiological or anatomical view of the breast. Each year, millions of women around the world are subjected to unnecessary breast biopsies because of inadequacies of cancer detection and inability to separate benign from cancerous lesions.

Thus to overcome the aforementioned drawbacks in various screening techniques for breast cancer there is strong felt a need to develop a novel and more effective screening device with high sensitivity and repeatability.

OBJECT OF THE INVENTION

The primary object of the present invention is to provide a novel imaging device with simultaneous digital X-Ray and Infrared red image acquisition and processing system in conjunction with a positioning apparatus for minimal radiation.

It is another object of the present invention to provide both anatomical and physiological view of the breast simultaneously for early detection of abnormalities.

It is still another object of the present invention to provide that each modality can still be used independently and/or in a concurrent fashion as needed or desired to provide images of the suspected area.

It is yet another object of the present invention to allow capturing of time based thermal images of multiple views (including but not limited to cranial, medial, caudal, lateral and frontal) of breast.

One more object of the present invention is to allow focusing on suspected area in follow-up procedure and also aids post processing treatment like targeted biopsy as well as targeted radiation

SUMMARY OF THE INVENTION

In accordance with this disclosure there is provided a device with an integrated system for simultaneous acquisition and processing of digital X-Ray and Infra Red imaging for enhanced breast imaging.

The device comprises patient support table with a position assembly mounted with an X-ray system and Infrared system. The entire positioning assembly is placed in a closed chamber with controlled temperature and humidity.

The positioning assembly comprises a microcontroller which will position its four axis (namely X, Y, Rotational and camera axis) based on the commands from computer. Each axis is actuated by separate motor which is driven by the microcontroller. By actuating X-Axis, the IR cameras and X-Ray source can be moved along horizontal axis. The IR camera which is parallel to X-ray source usually moves along the horizontal axis to capture frontal shot of the breast. Similarly by actuating Y-Axis both modalities can be positioned to image side views like caudal, cranial, medial and lateral portion of breast .Finally by actuating rotational axis it allows the system to capture 360 degree view of the breast. The Camera axis can be actuated to provide any desired tilt to IR camera to capture the breast thermal image.

This present device provides both anatomical and physiological view of the breast simultaneously for early detection of abnormalities. In addition, each modality can still be used independently and/or in a concurrent fashion as needed or desired. Images from both modalities can be overlapped to correlate anatomical and physiological view of the suspected area.

Further, in this present invention, diagnosis is based on the outcome of two modalities taken simultaneously, thereby leading to reduction in the number of false positive results when compared to conventional techniques.

Moreover it increases screening follow up as there is no pain or compression or any discomfort to the patients during this scan/procedure.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

The present disclosure will now be described with reference to the accompanying drawings, in which:

FIGURE 1 illustrates the front perspective view of the device with the following:

1. Opening for breast to image
2. Table for patient to lie in prone position
3. Positioning Assembly
4. Temperature controlled Chamber

FIGURE 2 illustrates the positioning assembly mounted with the X-RAY system with the following:

2. Patient Support table.
5. Camera axis
6. Y-Axis
7. X-axis
8. Rotational axis
9. X-Ray source
10. X-ray beam
11. X-ray detector
12. Infrared camera parallel to the source
13. Infrared camera perpendicular to x-ray source
14. Patient's breast
15. Biopsy device

And FIGURE 3 illustrates the positioning assembly mounted with the Infra Red system with the following:

2. Patient support table
5. Camera axis
6. Y-Axis
7. X-axis
8. Rotational axis
12. Infrared camera parallel to the source
13. Infrared camera perpendicular to x-ray source
14. Patient's breast
15. Biopsy device
16. Infrared camera in frontal position.
17. Assembly base.

DETAILED DESCRIPTION OF THE INVENTION:

The device with an integrated system in accordance with the present invention will now be described with reference to the accompanying drawings, which does not limit the scope and ambit of the disclosure.

Referring to the drawings, figure 1 represents the novel device with patient support table and positioning assembly in accordance with the present invention. The Device comprises of patient support 2 preferable an examination table wherein the patient lies in prone position such that patient's breast to be imaged extends through a hole 1, such as opening in the patient support. The patient's breast preferable extends downward through the opening. The bottom surface of the patient examination table as well as closed chamber is coated with X-ray radiation absorbing material like Lead (Pb) to avoid radiation leakage outside the chamber.

The commercially available infrared cameras 12, 13 are mounted on the positioning assembly 3. The entire positioning assembly is placed in a closed chamber 4 and its environment in terms temperature and humidity can be controlled.

The positioning assembly comprises a microcontroller which will position its four axis (namely X, Y, Rotational and camera axis) based on the commands from PC. Each axis is actuated by separate motor which is driven by the microcontroller. By actuating X-Axis 7, the IR cameras and X-Ray source can be moved along horizontal axis. The IR camera 12 which is parallel to X-ray source usually moves along the horizontal axis to capture frontal shot of the breast. Similarly by actuating Y-Axis 6, both modalities can be positioned to image side views like caudal, cranial, medial and lateral portion of breast.

Finally by actuating rotational axis 8, it allows the system to capture 360 degree view of the breast. Camera axis 5 can be actuated to provide any desired tilt to IR camera to capture the breast thermal image.

Referring to the drawings, figure 2 represents the x-ray system. An X-Ray source 9 is usually mounted near the infrared camera or at 90 degrees in the same plane so that same portion of the breast can be screened simultaneously by X-ray as well as Infrared rays and their physiological and anatomical characteristics can be overlapped to provide enhanced analysis.

This X-Ray source within the temperature controlled chamber provides a steam of x-ray radiation such that the x-rays 10 pass through the patient's breast and are received by an opposing x-ray detector 11 configured to receive the same. The X-ray detector is placed very close to the periphery of the breast.

Ideally a common support system, positioning assembly, 3 supports both infrared camera as well as X-ray system. When the Positioning assembly is actuated, it allows both the system, X-ray and Infrared system to rotate simultaneously around a vertical axis relative to the hole or one at time as desired. X-ray source 9 and detector 11 rotate in such a way that the patient's breast or a portion of the patient's breast 14 always remains in the x-ray path 10.

Since this invention allows the X-ray source to rotate around a vertical axis relative to the opening, the 360 degree view of the breast can be scanned in contradiction to the conventional mammography. Apart from this in conventional mammography, wherein the patients' breast 14 is compressed during procedure, is completely eliminated in this invention. Hence the system is more comfortable for the patients when compared to the existing systems. Within short time period, the patient's breast 14 is screened simultaneously in two modalities and their results are compared.

Referring to the drawings, figure 3 represents the Infrared system. The positioning assembly 3 will position IR cameras to capture all views not limited to namely cranial, medial, caudal, lateral and frontal of the breast.

This invention comprises two infrared cameras, and actuated in such a way that one camera can focus the portion of the breast which is under x-ray radiation and other system can capture other views of the breast independently. Hence this arrangement can reduce the procedural time.

This invention also allows positioning of two infrared cameras i.e one is parallel to the X-ray source 12 and another one perpendicular 13 to the x-ray source. The infrared camera which is in parallel with the x-ray source can capture the thermal images of the same portion of the breast which is under x-ray study. As well as this camera can be used to study the impact of X-ray on breast tissues (changes in heat pattern while breast is being subjected to X-ray).The position of X-ray source can be changed and can be positioned even very near to the breast for better analysis. But in all the cases, the positioning assembly will position in such a way that the both the X-ray source and infrared cameras will not come within the region of the breast opening provided in the table.

During clinical procedure, the patient is asked to lie down on the patient support 2 in prone position with one of their breast 14 in hole 1. Temperature controlled chamber will cools the chamber to the desired temperature. Now the patient is ready for screening, once this is done, the technician can select either X-ray or Infrared or both for screening. For Infrared system, the technician will select the view to be captured in user interface provided in PC.

This will be communicated to the microcontroller which in turn positions all axis accordingly and images are automatically captured and loaded into User interface. In similar way the technician can capture all views and can do post processing analysis like 3D analysis. For X-ray system, the x -ray source will starts sending radiation beam which will pass through the patient's breast 14 and captured by the detector. If the technician selects both, on the same region of the breast both x-ray image and thermal image captured simultaneously and loaded into user interface and these images can be displayed on the display separately and or overlapped to correlate the anatomical and physiological features of breast under scanned region.

When technician selects both modalities, the microcontroller will actuate its axis in such a way that both the system can scan the breast and can rotate around the vertical axis in relative to the hole, so complete side view of the breast can be screened in both the modalities simultaneously. While taking frontal image, the microcontroller disengages the x-ray system and moves infrared camera alone in such a way that its focus will be parallel to the table. Thus the invention is designed in such a way that two modalities wouldn't interfere in other operative position.

Same procedure can be repeated for next breast also. The biggest and foremost advantage of this invention is that both the system can be positioned to focus exactly to the same co-ordinate and at same angle in next breast for comparison with previous breast. For example if an abnormalities found in left breast at some angle say A degree and at co-ordinate X,Y , then this system can be positioned exactly to the same angle and same coordinate in the next breast also. So it will be very much useful to the radiologist to compare the results of normal Vs abnormal breast of same patient and at same visit.

Secondly, if any abnormalities suspected and marked for follow-up procedure then duration of follow-up procedure can be very much reduced by this invention, since the invention can position both the modalities exactly to the suspected spot. If the abnormalities diagnosed as tumor the invention is designed to allow targeted radiation as well as targeted biopsy.

TECHNICAL ADVANTAGES

The technical advantages of the present invention includes providing a novel imaging device system with simultaneous X-ray and Infrared image acquisition and processing system for enhanced breast Imaging.

The proposed device has the unique feature to capture two different images in 360 degree of the breast tissue of the patient lying in prone position by the integrated system.

The proposed device helps in an accurate diagnosis by the outcome of two modalities taken simultaneously, thereby leading to reduction in the number of false positive results when compared to conventional techniques.

The propose device allows capturing of time based infra red images of multiple views (including but not limited to cranial, medial, caudal, lateral and frontal) of breast.

We Claim:

1. A device with simultaneous X-ray and infrared acquisition and processing system for enhance breast imaging to correlate anatomical, physiological characteristic and post process 3D analysis , said device comprising a position assembly (3); a closed chamber (4); a patient support table to lie in prone position (2) and an opening (1) for the breast to image.

2. The device as claimed in claim 1, wherein said position assembly (3) is mounted with an Infrared system (12, 13&16) and X-ray system (9, 11) to capture the images simultaneously.

3. The device as claimed in claim 1, wherein said position assembly (3) has a microcontroller which will position its four axis (namely X, Y, Rotational and camera axis) based on the commands from personal computer and each axis is actuated by separate motor which is driven by the microcontroller.

4. The device as claimed in claim 1, wherein the said positioning assembly (3) can position both the mounted systems as required exactly to the same coordinate on another breast for comparison.

5. The device as claimed in claim 1, wherein said position assembly (3) mounted with Infrared system and X-ray system can rotate simultaneously around the vertical axis in relative to the opening (l)and thus allow acquisition of the full 360 degree view of the breast.

6. The device as claimed in claim 1, wherein said position assembly (3) can detect any abnormalities suspected and can position exactly to the suspected spot and aids in targeted radiation and targeted biopsies for post process treatment.

7. The device as claimed in claim 2, wherein said mounted Infrared systems and X-ray systems can be moved along horizontal axis towards or away from the patient breast for enhanced analysis.

8. The device as claimed in claim 2, wherein said mounted Infrared system and the X-ray system at any instant are positioned at a certain distance away from the center of the opening (1) and hence no portion of the system will come in contact or touch patient's breast

9. The device as claimed in claim 2, wherein said mounted system's cameras can be can be tilted to any required degree to screen complete portion of breast.

10. The device as claimed in claim 2, wherein said mounted X -Ray system radiation impact on the breast tissue can be studied using the Infrared system images.

11. The device as claimed in claim 2, wherein said infrared system and X-ray system can be used independently or simultaneously tilted to cover full breast for imaging as desired.

12. The device as claimed in claim 2, wherein said infrared system and X-ray system are designed in such a way that infrared system positioning won't interfere operating position of x-ray system.

13. The device as claimed in claim 1, wherein said patient support table (2) is configured to support the patient and exposes only the breast for screening and without making any discomfort to the patients.

14. The device as claimed in claim 1, wherein said patient support table (2) and the closed chamber(4) are coated with X-ray radiation absorbing material like Lead (Pb) to avoid radiation leakage.

15. The device as claimed in claim 1,wherein said closed chamber (4) temperature and humidity is controlled and set as desired by the techinician.