WO2014178085A2

WO2014178085A2 - A system integrated with communicating device for medical analysis of biological matter

Info

Publication number: WO2014178085A2
Application number: PCT/IN2014/000297
Authority: WO
Inventors: Ashish Jain; Sharad Jain
Original assignee: Ashish Jain; Sharad Jain
Priority date: 2013-05-02
Filing date: 2014-05-02
Publication date: 2014-11-06
Also published as: WO2014178085A3

Abstract

The present invention provides a system comprising a measuring device miniaturized into a single integrated chip (IC) within a communicating device for performing a medical analysis of biological matter of a user. The IC chip senses the biological matter and further analyzes the desired medical reading in the biological matter. The communicating device comprises a processing module including an application related to the measuring device which can be run on the communicating device. With the help of the application, the working principle of glucometer can be used to analyze various other blood components. All tets can be done by a single IC chip which is incorporated in the communicating device. A user may select a desired medical analysis and get readings for the selected medical analysis. The application enables the communicating device to call a concerned person for a user when reading analyzed is beyond the normal values.

Description

A SYSTEM INTEGRATED WITH A COMMUNICATING DEVICE FOR MEDICAL

ANALYSIS OF BIOLOGICAL MATTER

FIELD OF INVENTION:

The present invention generally relates to measuring/testing device, such as a, glucometer for analyzing blood samples, and more particularly relates to a testing device with a communication device, such as referred to as glucophones, for analyzing and keeping a check on the blood test readings. i

BACKGROUND OF INVENTION:

A glucometer is used to determine the approximate concentration of blood glucose. It is a device for self monitoring of blood glucose and necessary for emergency situations like hypoglycaemia ^' when blood glucose values are required immediately. A small drop of blood, obtained by pricking the skin is placed on a disposable test strip that the meter reads and uses to calculate the blood sugar reading. The meter, then displays the reading in mg/dl or mmol/l. The main goal of the management of diabetes is to achieve physiologically normal readings of blood glucose, guided by SMBG (Self Monitoring Blood Glucose) which long term and short term compl ication^'s.

of glucose to gluconolactone catalyzed by glucose

rs use a similar reaction catalysed instead by another enzyme, glucose dehydrogenase (GDH). This has the advantage of sensitivity over glucose oxidase but is more susceptible to interfering reactions with other substances.

The first-generation devices relied on the same colorimetric reaction that is still used nowadays ips for urine. Besides glucose oxidase, the test kit contains which is oxidized to a blue polymer by thehydrogen peroxide formed in

Most glucometers today use an electrochemical method. Test strips contain a capillary that sucks up a reproducible amount of blood. The glucose in the blood reacts with an enzyme electrode containing glucose oxidase (or dehydrogenase). The enzyme is reoxidized with an excess of a mediator reagant, such as a ferricyanide ion, a ferrocene derivative or osmium bipyridyl complex. The mediator in turn is reoxidised by reaction at the electrode,which generates an electrical current. The total charge passing through the electrode is proportional to the amount of glucose in the blood that has reacted with the enzyme. The coulometric method is a technique where the total amount of charge generated by the glucose oxidation reaction is measured over a period of time.

The amperometric method is used by some meters and measures the electrical current generated at a specific point in time by the glucose reaction. Characteristic of a conventional glucometer

Size: The size matches with that of the palm of the hand for most of the devices and are battery operated. :■ Test strips: A consumable element containing chemicals that react with glucose in the drop of blood is used for each measurement. For some models this element is a plastic test strip

required larger blood samples, usually defined as a "hanging drop" from the fingertip). Smaller volume requirements reduce the chances of unproductive pricks. Testing time: The testing time varies from 3 to 60 seconds depending on the type of glucometer used.

Display: The glucose value in mg/dl or mmol/1 are displayed on the glucometer screen Whole blood glucose vs. plasma glucose:Glucose readings in plasma are generally 10%-15% higher;th¾fi glucose, measurements in whole blood . It is important because glucometers measure the glucose in whole blood while lab tests measure the glucose in plasma. At present, some glucometers provide a "plasma equivalent," value , though they are measuring whole blood glucose.

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Clock/memory: Glucometers have a clock that is set by the user for date and time and a memory for past test results. The memory helps the diabetic patient to keep a record of management and look for trends and patterns in blood glucose readings over a period of time. Data transfer: In case of advanced glucometers the blood sugar values can be downloaded by a cable o infrared to a computer which displays the test results. Some glucometers allow entry :of a nformation like insulin dose, carbohydrate intake and exercise.

Glucometer as an attachement to cellphone: Healthpia obtained FDA approval for its patent- pending technology (AROUND 2007) that integrated a blood glucose meter with a standard- issue cellphone. It not only allowed you to send results over the air, but specially equipped mobiles were to be fitted with a Gluco Pack that enables you to test yourself as you would with any other glucometer. The company supposedly announced that Verizon's LG5200 would be the first to sport such technology.

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The iBGStar glucometer by Sanofi-Aventis with iPhone and iPod connectivity allows diabetics to re'c¾idi'300; glucose readings, with each test session lasting 6 seconds, and then send the data to thei ^;sdb©t¾ft¾ Saiiof½ vends also makes a stand-alone version of the mobile device called BGStar,^;:.which 'wiirhold 1,865 test results, recording the date, testing time and meal time. The BGStar unit also sends up to seven alerts to notify users when it's time to take a reading. Johnson & Johnson's LifeScan division demonstrated its OneTouch glucose-reading gadgets at Apple's iPhone 3.0 preview event in March 2009. The OneTouch units connect to the iPhone via Bluetooth.

A study by the Deloitte Center found that diabetic and hypertensive patients at the Creadingand Clinic who used their smart phones to send medical readings to electronic medical records kept by physicians were able to reduce their visits to the doctor's office. According to this study, mobile devices have a big future in health monitoring.

A lot of prior arts discuss about glucophones being used as a technology to analyse blood samples for sugar/glucose test, and also for the recording and communication of such readings to a storage database or a concerned person.

A patent number WO2005079664A 1 discloses a device which is provided for the measurement of blood glucose values. Said device is either a plug-in or retrofit device which is connected to a mobile communication device or as a fully integrated blood glucose measurement device integrated into a mobile communication device and consists of at least an input means for capturing or measuring blood glucose readings. Said invention therefore makes use of the common components of the mobile communication device such as it's input (keyboard), processing and output (screen) means. By increasing the amount of common components that can be shared by the measuring device and the communication device, the overall cost and size of th xorabined ' invention is reduced. This results in a more conventient device which enables both blood glucose measurement and communication. The invention further extends to a database where blood glucose values obtained from said measuring device and other relevant information are stored on the mobile phone's storage means. The higher reading of processing power, and larger storage capacity typically found in a mobile communication device allows several software applications to be developed to interpret blood glucose values and trends

terminal, the adaptor being equipped with minimal functions to perform blood sugar tests. In addition, both the mobile terminal with integrated blood sugar test function and the mobile terminal connected to the above blood sugar test adaptor can transmit measured blood sugar reading to the blood sugar reading administration server. A strip case is provided for at an outer surface of the mobi le terminal itself in the former, while a strip case is located at an outer surface of the adaptor in the latter.

Another patent number WO2006092323 discusses to a mobile telephone provided with an integrated measuring module, which is shielded against electromagnetic waves emitted by said mobile telephone. A test strip used in the measuring module and shielded against electromagnetic waves is also disclosed.;

Further, a patent CN2874949 discloses a mobile phone with blood lipid testing function, which comprises a CPU, a storage, a display, a keyboard and a blood lipid testing sensor chip that are connected with the CPU. The blood lipid concentration can be real-time measured by the mobile phone and displayed on the display, so as to take active response measures. In addition, the mobile phone has the functions of acquiring more information and health consulting service from a network medical service system that provides related services; storing the testing results for each time; facilitating history query and analysis; and providing health reminds based on the preset standard value and testing results. Because the mobile phone is wireless networking

s All of the! abdiverraentioned prior arts disclose a glucometer installed within or can be used as a plug-in device with a PC/T ablet or a smart phone for knowing the blood sugar content. However, they do not disclose a device which could be able to diagnose other medical conditions as well, such as cholestrol reading, urea tests, haemoglobin, lipid and the like. Hence, a universal device is not disclosed in prior art technologies. Furthermore, the prior art technologies failed to disclose a single device solution which miniaturizes the size of the measuring device so that it does not include with the design of the communication device and hence, do not tamper the design. Therefore, there is a need of a measuring device, working on the same principle as a glucometer or the, function is in other ways easily integratable with that of a mobi le communication device, capable of performing blood analysis for measuring readings of a variety of medical conditions integrated with a smart device capable of communication, where the design of the measuring device: is miniaturized ahd integrated with the communication device in a manner that it does not tamper w ith the design of the communication design. Further, there is a need of a measuring device which is portable and easy to use for every person.

SUMMARY OF THE INVENTION

processing module, wherein the integrated circuit chip does not tamper with the design of the communicating device.

Another embodiment of the invention discloses a A method of analyzing a sample of biological maftefcby- a sei¾9Qiji irJsing: integrating the miniatured measuring device on the communicating devic#_;iri;. aTrhafrhfcf 'without tampering the design and circuitry of the communicating device; taking the sample of biological matter on a test strip; inserting the test strip into a provision provided iii the communicating device for analyzing the sample; selecting the type of medical test to be performed through processing module in the communicating device; sensing of the sample of biological matter by the biosensor circuit on the measuring device minitured into an integrated circuit chip; analysis of the sample by the miniature measuring device integrated with the communicating device; and displaying readings of the selected medical test by the processing module through the display means of the communicating device. Another embodiment of the invention discloses the integrated circu it chip is pasted on the inside of the back panel of .the communicating device, between the back panel and the battery, or outside the back panel, without tampering with the design and circuitry and violating any warranty of the communicating device. An embodiment of the invention discloses the communicating device is provided with a

performing medical analysis for glucose/sugar readings, cholesterol readings, urea, l ipid profiles and the like.

Before the present methods and apparatuses are described, it is to be understood that this invention is hot limited to the particular apparatus and methodologies described, as there can be multiple possible embodiments of the present invention which are not expressly illustrated in the present disclosure. It is also to be understood that the terminology used in the description is for the purpose of describing the particular versions or embodiments only, and is not intended to limit the scope of the present invention which will be limited only by the appended claims.

This patent i"describes : he subject matter for patenting with specificity to meet statutory requirements,^' However, the description itself is not intended to limit the scope of this patent. The principles described herein may be embodied in many different forms.

Illustrative embodiments of the invention now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the

The measuring device ( 102) works integrally within a communicating device (104). Such a small IC chip ( 106) when integrated within the communicating device ( 104) does not tamper with the design and circuitry of the communicating device (104). Also, this complete solution of the IC chip (106) integrated within the communicating device ( 104) does not have any extra protrusion other than the feature size of the communicating device (104).

In art embodiment of the invention, the communicating device ( 104) is any electronic device capable o sending and receiving information to and from other devices using wired and

configured td (l 12) execute the application (108) which is related to the working of the IC chip ( 106) of the measuring device (102). Further, the application (108) is stored in the memory of the communicating device (104). The communicating device (104) is capable of installing and downloading the application (108). The application (108) performs as an interface between the measuring device (102) and the user, at the communicating device (104). The application (108) aids in easy operation and handling of the working of the measuring device (102) at the communicating device (104) by a user.

Such communicating device (104) integrated with the said IC chip (106) is provided with a provision to insert a test, strip with a sample of biological matter, which further communicates with the IC chip (106) to analyze the sample. In an embodiment, the measuring device (102) is a gluc^'ometer and the sample of biological matter is a blood sample which is put on a test strip, and thetest strip is inserted into the provision in the communicating device (104) for analysis of the blood sample:

Further, the measuring device (102) comprising the IC chip (106) of such a small size is capable of performing medical analysis to test a variety of medical conditions. In an embodiment, the measuring-device (102) helps in analyzing sugar/glucose levels for a user. In an embodiment, the measuring device (102) helps in analyzing cholesterol levels for a user. In a further embodiment,

communicating device (104). In an embodiment of the invention, the microprocessor ( 1 12) is configured to execute the application (108) for asking the user about his/her details, such as name, age, sex, name of the doctor, contact number of the doctor, his own contact number and the like. By doing this, the application (108) stores the medical tests performed by the user along

and details. This may be done by the application ( 108) executed by the microprocessor ( 1 12) in a way that the application ( 108) everytime asks the name of the user performing the medical test/analysis. If that name is already stored in the memory of the communicating device ( 104),

Further, the u^'ser may select a medical test, from the application ( 108), he wishes to perform. For example, ;heishe may 'select a sugar test to be performed. As soon as the user selects the desired test; a biosensor; included in the IC chip (106) of the measuring device (102) may be activated. The biosensor may. further, sense the blood sample on the test strip.

Resultaritly, the IC chip (106) of the measuring device (102) may analyze the blood sample and may calculate the level of sugar content in the blood sample. It may be obvious to a person skilled in the art that the measuring device (102) as disclosed in the invention may function on a number of working principles which are the same principles on which a glucometer works (the working principles of glucometer are discussed above in the Background of Invention). The single IC chip ( 106) forming the measuring device (102) disclosed in the invention works on the same -principles as other medical measuring devices, such as glucometer, work. In this example; the , LC chip ( 106) calculates the sugar level in the blood sample. Consequently, the result of the blood test, here reading of sugar level, is displayed on the screen of the mobile phone of the user. The application ( 108) displays the reading to the user, along with a range of normal blood sugar level. In this way, the user may become aware of his/her sugar level along with a normal range and has an understanding of any fluctuations of his/her sugar level from the normal range. "

In an, embodiment of the invention, after performing a desired test by the user using the measuring device ( 102), the microprocessor (1 12) of the processing module ( 1 10) causes the application (108) to call a concerned person in the case where the resultant reading of the medical test is fluctuating beyond the normal range provided. In this case, the application ( 102) causes, the communicating device (104) to dial a stored number provided by the user with the detall¾. :X;h^:e cpjfsje.rhed person may be a doctor, or a physician, a nurse, a consultant, a relative or any other person- who can be contacted in cases of emergency.

In another embodiment, the application ( 108) can also store the readings of the medical tests performed by the user on a server location, when the communicating device (104) is connected with a server, world wide web, through a wired or wireless communication network, such as LAN, WAN, Internet. Hence, besides storing the data of the medical tests for a user, the application ( 108) can also store the data on the server, which can act as a secondary database, in case the database on the communicating device (104) is lost.

Figure 2 shows a flowchart for a method performing a medical analysis of a biological matter using a device, such as a measuring device ( 102), in accordance with an embodiment of the invention. According to. the present invention, a measuring device ( 102) for performing a medic.a| ;atjaJ sis/t:est' ^'ρΐ( sample of a biological matter, comprising an integrated circuit (IC) chip ( 106) which further includes a biosensor circuit to sense the sample of biological matter. The^' IQ chip ;( 106) is unified within a communicating device (104) in such a way that the IC chip (106) does not tarn per. with the design and circuitry of the communicating device (104). In an embodiment, the sample of biological matter is a blood sample.

analysis: at a displaying means, such as a screen, of the communicating device ( 104). The application ( 108) is related to the operation of the measuring device (102) and acts as a communicating means between the measuring device (102) and a user at the user's communicating device ( 104). Hence, the microprocessor (1 12) configured to execute the

panel of the communicating device (104).

In an embodiment of the invention, , the communicating device (104) is any electronic device capable of sending and receiving information to and from other devices using wired and wireless communication protocols, such as a smart mobile phone, or a tablet, or an IPad, or a smart watch, and the like devices.

disclosed in' the invention works on the same principles as other medical measuring devices, such as glucometer, work. Resultantly, at step 212, the application (108) of the processing module (1 10) displays the readings of the selected medical test on the displaying means, such as screen, of the communicating device (104), which are visible to the user. Hence, the measuring device ( 102) efficiently performs a desired medical analysis and displays the readings at the communicating

why, the measuring device may be termed as a universal device capable of doing a variety of blood tests; which is portable and very easy to use.

Furthermore, the present invention also discloses the application causing the communicating device to call a . concerned person for a user, in cases when the test result readings fluctuate beyond the normal range. In this way, in a serious emergency situation, a concerned person for the';user inay. be informedi The concerned person may anyone like a doctor, a nurse, a relative, a friendi Further, the name and contact details of such person may be stored by the user using the application; irr the conTjnunicating device. The? mnbvarive"'p'r0duct^! as developed has the capability to monitor the content of blood sugar present at every moment in a diabetic patient. This innovative and smart device includes the cell phone integrated w ith an inbuilt mechanism for self blood glucose monitoring. The device is expected to improve diabetes care through improved self monitoring and awareness because of ie^'asy nand, 24~hrs ; accessibility. In addition it allows storage and transmission of the everyday orieven /hourly :re,ports to a doctor. This could prove to be an immensely useful tool in clinical research as a huge database would be available for critical evaluation for more accurate diagnosis and: indiy idualized treatment. The present invention could prove to be a breakthrough technology for reducing the cost for managing|,chron;ic; conditions such as diabetes and obesity and is targeted at patients in rural and underserved areas to health conscious individuals looking for better diagnosis and treatments at reduced health-care costs.

Consequently, 'the present invention discloses a complete solution for performing various blood tests anywhere anytime by a single device.

Although the present invention has been described with reference to certain preferred embodiments and examples thereof, other embodiments and equivalents are possible together with functional and procedural details and examples, the disclosure is illustrative only, and changes may ibe made in detail, especially in terms of functional elements within the principles of the invention'. Thus, various modifications are possible of the presently disclosed system without deviating from the intended scope and spirit of the present invention

Claims

We claim:

(1 ) A system: for performing a medical analysis of a sample of biological matter by a user, comprising: \ ^' _;! i- a measuring device including a biosensor circuit to sense the biological matter miniaturized into an integrated circuit chip with a size range of 6mmX6mm to 2inmX2mm for performing the medical analysis of the sample;

a communicating device, where the miniatured measuring device performing the medical analysis is integrated with the communicating device without tampering with the design arid circuitry of the communicating device; and

a processing module including a microprocessor for enabling communication between the measuring device and the communicating device and enabling communication between the user and the measuring device through communication device -.

(2) The system as claimed in claim 1 , wherein the measuring device is miniature into an integrated circuit chip preferably of the size 5mmX5mm.

(3) The system as claimed in claim 1 , wherein the measuring device is capable of performing the medical analysis for glucose/sugar readings, cholesterol readings, urea, lipid profiles, and additional medical parameters like haemoglobin, pulsemeter, temperature and the like.

(4) The system as claimed in claim 1 , wherein the measuring device is pasted on the inside of the back panel of the communicating device, between the back panel and the battery, or outside, the back panel, without tampering with the design and circuitry and violating any warranty of the communicating device.

(5) The systeni as claimed in claim 1 , wherein the microprocessor of the processing module is configured to ^' execute the display of the results of the medical analysis to the user through the displaying means of the communicating device; and enable the communicating device to call a concerned person in case where the result of a medical analysis performed fluctuates beyond a normal range.

(6) The system a claimed in claim 1 , wherein the communicating device is provided with a provision to insert a test strip containing the sample of biological matter for coinniurticating^'the sample to the - measuring device.

(7) The system as claimed in claim 1, wherein the biological matter is a blood sample of a user. ' ^':

(8) The system _as claimed in claim 1, wherein the measuring device is a glucometer, and the biosensor is the glucosensor.

(9) The system as claimed in claim 1 , wherein the communicating device is a smart mobile phone, or a tablet, or an iPad, or a smart watch and the like devices.

(10) A measuring device including a biosensor circuit to sense the sample of biological matter capable of performing a medical analysis of a sample of biological matter, where the measuring device is miniaturized into a single integrated circuit chip wherein, size of the said integrated chip is in the range of 6mmX6mm to 2mmX2mm ; and

the integrated circuit chip is integrated with a communicating device including a processing module, and wherein the integrated circuit chip does not tamper with the design of the communicating device.

(1 1) The measuring, device as claimed in claim 10, wherein the size of the integrated circuit chip is preferably 5mmX5mm.

(12) The measuring device as claimed in claim 10, wherein the measuring device is capable of performing medical tests/analysis for glucose/sugar readings, cholesterol readings, urea, lipid profiles and additional medical parameters like haemoglobin, pulsemeter, temperature and the like. (13) Trie measuring device as claimed in claim 10, wherein the measuring device is a gjuco meter, and the biosensor is the glucosensor.

(14) The measuring: device as claimed in claim 10, wherein the biological matter is a blood sample of a user. _:

(15) The measuring device as claimed in claim 10, wherein the communicating device is a smarl mobile phone, a tablet, an iPad, a smart watch and the like devices.

(16) The measuring device as claimed in claim 10, wherein the said measuring device miniatured in the integrated circuit chip is pasted on the inside of the back panel of the communicating device, between the back panel and the battery, or outside the back panel, without tampering with the design and circuitry and violating any warranty of the communicating device.

(17) The measuring device as claimed in claim 9, wherein the processing module is configured to execute the display of the results of the medical analysis to the user through the displaying means of the communicating device; and

to enable the communicating device to call a concerned person in case where the result of a medical analysis performed fluctuates beyond a normal range.

(18) A method of analyzing a sample of biological matter by a user, comprising:

integrating the miniatured measuring device on the communicating device in a manner without tampering the design and circuitry of the communicating device;

taking the sample of biological matter on a test strip;

inserting the test strip into a provision provided in the communicating device for analyzing the sample;

selecting the type of medical test to be performed through processing module in the communicating device;

sensing o the sample of biological matter by the biosensor circuit on the measuring device minitured into an integrated circuit chip;

the biosensor is the glucosensor.

(21 ) The method as claimed in claim 19, wherein medical test include analysis of glucose/sugar readings, cholesterol readings, urea, lipid profiles and additional medical parameters like haemoglobin, pulsemeter, temperature and the like.

(22) The method as claimed in claim 16, wherein the biological matter is a blood sample of a user.

(23) The method as claimed in claim 19, wherein the communicating device is a smart mobile phone, or a tablet, Or an iPad, or a smart watch and the like devices.

(24) The method as claimed in claim 19, wherein the processing module is configured to execute display of the results of the medical analysis to the user through the display means of_. the communicating device; and to enable the communicating device to call a concerned person in case where the result of a medical analysis performed fluctuates beyond a normal range.