CLIAMS:- ,TagSPECI:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&

THE PATENTS RULES, 2003
PROVISIONAL SPECIFICATION
[See section 10, Rule 13]

METHOD AND SYSTEM FOR HAEMOGLOBIN MEASUREMENT;

BIOSENSE TECHNOLOGIES PRIVATE LTD, WHOSE ADDRESS IS 102 ORION BUSINESS PARK, NEAR CINE WONDER MALL, KAPURBAWADI, THANE WEST-400607, MAHARASHTRA, INDIA

THE FOLLOWING SPECIFICATION DESCRIBES THE INVENTION

FIELD OF THE INVENTION
[001] The invention relates to haemoglobin measurement and more particularly the invention relates to non-invasive method and system for haemoglobin measurement.

BACKGROUND OF THE INVENTION
[002] Haemoglobin is an iron containing protein in blood cells which carries oxygen around the body. Lack of haemoglobin in blood results in inadequate supply of oxygen to the body and causes various complications such as anaemia. Some of the main causes of anaemia are loss of blood, nutritional deficiency, bone marrow problems, kidney failure, abnormal haemoglobin structure, etc. Also, a high level of haemoglobin in blood leads to several complications since it can impair circulation and also lead to abnormal clotting. Measurement of haemoglobin in blood is thus an important routine procedure for monitoring patients under treatment and for screening for anemia especially in pregnant women, women of reproductive age etc.
[003] Several invasive and non-invasive techniques are available for measurement of haemoglobin. Invasive techniques include drawing of blood sample which is a painful experience for a patient. Also, it exposes a health care provider handling the blood sample to risk of infectious diseases.
[004] Non-invasive techniques include use of devices similar to oximeters on a thumb or a ear of patient to measure the level of haemoglobin. However these oximeters are expensive and are mostly used in intensive care units for continous monitoring of the patient.
[005] Another conventional method of checking for low levels of haemoglobin i.e. checking for anaemic conditions of the subject is to check conjunctiva of the eye of the subject visually by a healthcare worker. The conjunctiva is a thin membrane that covers inner surface of the eyelid and white part of the eyeball. The conjunctiva is normally visible when the eye is pulled down. Doctors/physicians usually check the conjunctiva for its redness or paleness to examine anaemic condition of the patient. In case of anaemia, the anterior and the posterior rim of the conjunctiva will be same and will be pale. For a healthy subject, the anterior rim of the conjunctiva will have more redness and will be dissimilar to that of the posterior part. However this technique is subjective and is only indicative of low level of haemoglobin or anaemic condition and does not give a quantitative analysis of the amount of haemoglobin in blood. In view of the above, there is a need in the art for a method and system for haemoglobin measurement addressing at-least the above mentioned problems.

DESCRIPTION OF THE INVENTION
[006] Various embodiments of the present invention provide diagnostic devices devices, systems and methods for haemoglobin measurement. More particularly the invention is directed to analyzing conjunctiva of an eye for measuring the level of haemoglobin of a subject/patient. In an example embodiment, the invention is implemented as an application running on a portable device, such as a cell phone, computer, laptop, or other dedicated portable electronic device.
[007] In an embodiment, the present invention provides a system for haemoglobin measurement, the system comprises an external device, the external device adaptable to an eye of a subject under test; and an electronic device adaptable to the external device, the electronic device including a camera and a processor. The camera is for capturing an image of conjunctiva of the eye illuminated by a light source provided on the external device or the electronic device. The processor is configured for identify plurality of red pixels in the conjunctiva from the image, extracting color value of the red content in the pixels, and comparing the color value with calibrated color values of haemoglobin to retrieve a parameter value which indicates the level of haemoglobin.
[008] In another embodiment, the present invention provides a method for haemoglobin measurement, the method comprises the step of adapting a external device to a subjects eye such that it covers the eye of the subject; exposing conjunctiva area of the eye; illuminating the exposed conjunctiva of the eye; capturing at-least one image of the exposed conjunctiva, analyzing the captured image to identify plurality of red pixels in the conjunctiva, extracting color values of the red content in the pixels from the image, and comparing the color value with calibrated color values of haemoglobin to retrieve a parameter value which indicates the level of haemoglobin.
[009] Figure 1 shows a system 100 for haemoglobin measurement in accordance with an embodiment of the invention. The system as shown includes an external device 200 (shown in figure 2), and an electronic device 110 adapted to the external device. The electronic device includes an image capturing device 112, a processor 114 a storage means 116 and a display 118. In an embodiment of the invention, the external device can be retrofitted on electronic devices such as a cell phone, computer, laptop, or other portable electronic devices. Accordingly, the external device can be adapted to different types of electronic devices and the external device is not limited to the arrangement illustrated through the figures.
[010] Figure 2 shows an exploded view of the external device 200 in accordance with an embodiment of the invention. The external device 200 is capable of being adapted to the eye of the subject.
[011] The external device 200 includes a first adapter 210, a barrel 220 and a second adapter 230. The first adapter is provided for adapting the barrel to the electronic device. The first adapter holds the electronic device such that the image capturing device of the electronic device is aligned with the external device. As shown, the first adapter has means 212 for accommodating a power source 214 for the external device. Alternately, the external device can be powered though the electronic device via suitable means.
[012] The barrel extends from a first end to a second end. The barrel which may also be referred to as housing has an illumination source 222 and a light diffuser 224 disposed within the barrel. At the first end the barrel is adapted to the electronic device via the first adapter. At the second end the barrel is provided with the second adapter. The second adapter is provided for placing the external device on the eye of the subject. In an embodiment of the invention, barrel and the second adapter of the device are light occluding. In this regard, the second adapter covers the eye such that the eye is isolated from ambient light. Once the device is placed on the eye of the subject, the light source of the device is turned on and the eye of the subject is illuminated. In an embodiment, the light diffuser is provided in front of the light source such that that light spreads uniformly over the entire eye area, thereby avoiding any patchy illumination.
[013] Upon illuminating the subject’s eye, conjunctiva of the eye is exposed by pulling down lower eyelid of the eye. Subsequently at-least one image of the exposed eye is captured via the image capturing device.
[014] In an embodiment, the processor of the electronic device is configured for processing the captured image of the exposed conjunctiva of the eye. The captured image is processed by identifying plurality of red pixels in the conjunctiva. Further, the processor extracts color values of the red content in the pixels to retrieve a color value. Extracting the color values may include extacting the color content such as depth of colour, brightness of colour, variations in shade, tint, tone, tincture, etc. Upon extracting the color values, the processor compares the color values of the red content in the pixel with the calibrated color values of haemoglobin to retrieve a parameter value which indicates the level of haemoglobin.
[015] In an embodiment storage means stores reference data – calibrated color values of haemoglobin which correspond to content of haemoglobin in blood. Also, the storage means is provided for storing test results along with date, time and other parameters.
[016] In an embodiment the haemoglobin measured by the system can be displayed or printed to indicate the haemoglobin concentration. In this regard, the haemoglobin measured is displayed or printed in terms of gm/dL.
[017] In an embodiment, the system further comprises at-least one remote server configured via at least one communication network to the electronic device which is capable of receiving the haemoglobin value measured for further analysis.
[018] Advantageously, the present invention provides a point of care portable device for measuring haemoglobin which is simple to use and cost effective because of its simple construction.
[019] The foregoing description of the invention has been set merely to illustrate the invention and is not intended to be limiting. Since modifications of the disclosed embodiments incorporating the spirit and substance of the invention may occur to person skilled in the art, the invention should be construed to include everything within the scope of the disclosure.
Dated this 19th day of May, 2014
For Biosense Technologies Private Ltd.
By their Agent

(Manish Saurastri)
Patent Agent No.: IN/PA 291
KRISHNA & SAURASTRI ASSOCIATES