Abstract:
The Magic Gluco Wrist Watch (MGW) is a time wrist watch with a capability to measure the blood glucose level. The fix watch clasp plays a role of a lancing device, and is attached to the end of a left strap of the MGW. The movement of a holding member from the left strap to a right strap causes new electric current test strip to be driven in to the test strip port. A test strip port is located in the lug. By opening the valve, the MGW turns from time watch into a blood glucose meter.

Description:
FIELD OF THE INVENTION 
       [0001]    The invention relates to a blood glucose meter, in the shape of a wristwatch, which combines a lancing device, a time measuring device and a hollow watch strap to hold a plenty of electric current test strips. In this invention the lancing device is designed to fasten the watch strap. 
       BACKGROUND 
       [0002]    According to the statistics of the International Diabetes Federation (IDF), one of the most prevalent metabolic disorders is diabetes. Because of this chronic disease, the body cannot produce enough insulin or absorb it efficiently. Nowadays, in average, one out of six people is diabetic. Recent studies show that one, by controlling blood glucose level, injecting timely proportionate insulin, exercising regularly and having a healthy dietary program, can prevent diabetes repercussions. So measuring blood glucose level before and after food and before going to sleep, on a daily basis, is a key factor for diabetics to live healthy without diabetes side effects. 
         [0003]    Therefore due to increasing number of diabetics and increasing demand in the market for medical instruments to control the disease, there was a need to overcome the shortcomings of older glucose measuring models. 
         [0004]    Today most of the glucometers in the market comprise of three separate components: 
         [0000]    Screen, lancet, and strip, packed together in a small bag. Because of different separate components, these kinds of glucometers are not efficient in all situations especially in outdoor situations. 
         [0005]    It is noteworthy that most of the type 1 diabetics (dependent on insulin) are children or youth who are very active and usually stay outdoor in schools or universities during the day. For example when a diabetic is playing or driving car or is walking on the street in rush hour, cannot easily open the bag and use several components to measure his/her blood glucose. 
         [0006]    Because of these shortcomings, the diabetics who are dependent on insulin cannot control the fluctuations of their blood glucose level regularly. Therefore “accessibility” and “user friendly” are the most important features of such a device to provide convenience for diabetics to control their blood glucose every time in every situation or in every location to mitigate any side effect of the disease in the future. 
         [0007]    Diabetics dependent on Insulin (type 1) contrary to independent diabetics (type 2) normally face with blood glucose level fluctuations during the day. So multiple blood testing is necessary for them to control these fluctuations as soon as possible. Therefore “easy to use” feature of device and “having access” to it in every situation is very vital for the users. 
         [0008]    A diagnostic apparatus of this type is known from U.S. 2013/0274568 A1, an arrangement comprises housing multiple needles. Each needle has an inner passageway or lumen, an analyst quantification member that comprise an assay pad is provided in communication with the lumen of the needle, can receive a sample of blood produced by the piercing of the user&#39;s skin with the needle. Each needle pierces the user&#39;s skin by the torsional spring elements that are mounted to triggering member. The plurality of components of this device such as plurality of needles and the actuators indicates the complexity of the system, which causes the manufacturing and assembling of device becomes more sophisticated and expensive. Also changing the used needles and assay pads couldn&#39;t be user friendly. 
         [0009]    U.S 2014/0114160A1 shows a blood testing apparatus which includes a laser source configured to produce a wound from which blood flows for measuring its glucose level. This apparatus has also a plenty of components which make it complex and big. These features altogether could lessen the attractiveness of the device and increase its manufacturing cost. 
       SUMMARY OF THE INVENTION 
       [0010]    Regarding the needs of diabetics for multiple testing and the difficulties they face to maintain the balance of their blood glucose level, in this invention a device is designed in a way to be wearable and being attached to the user, to be as compact and integrated as possible, and to be user friendly. 
         [0011]    I decided to design the device in the shape of a wristwatch and to use each part of it as a component of the conventional glucometer. Thus each part of the Magic Gluco Wrist Watch (MGW) has multifunction. For example the glucowatch strap beside the function of fastening the MGW around the wrist of the user, also has the function of holding the electric current test strips and the lancing device. The other competitive advantage of this invention compared to other devices is its simplicity. 
         [0012]    MGW has less components, is easy to assemble and to manufacture and easy to repair. This invention despite to other new-designed devices is a mechanical device and doesn&#39;t include any electromechanical components that renders the device complex and not easy to use, which causes complexity rather than simplicity of the device. 
         [0013]    In this invention, MGW is a portable device which provides a simple and fast method for rapid monitoring of the blood glucose level by utilizing a blood sample from the user&#39;s fingertip. The MGW is a smart digital wristwatch capable of displaying time, date, location of a user, weather forecast, heart rate, body temperature, emails as well as any information being transmitted to the smart wristwatch via Bluthooth™, WIFI, or home internet or any user data being transmitted via any communication protocols through a transmitting means such as a mobile smart phone, any type of computer or laptop, received by a receiving means located inside the watch (Incorporated by reference to U.S. Pat. No. 8,787,006 Golko et al). Where the user can enter any kind of data via a touch screen display and interact with the data received to the wristwatch or smart phone or computer or laptop as well send glucose measurement date saved on a memory inside the watch when needed, either manually or automatically. 
         [0014]    The user can utilize programs and softwares created for diabetic patients in order to send any glucose measurement data continuously or during specific time intervals or at one point to his/her smart phone, laptop or any computer such as a physician&#39;s office. 
         [0015]    All the data processing and analyzing is performed via a watch processing mean (not shown, but well known in the art of smart watches and smart phones). The watch comprises necessary transmitter, receiver means in order to communicate and receive data as well as a CPU designed to control and run the whole system including the watch processing mean and glucose measurement unit (data received by test strips, glucose level, insulin intake and so on). The watch comprises two alarm systems one used for the wrist watch and works as an alarm clock and the other alarm is for alerting the user when his/her insulin level falls below a certain level. The alarm system can also send signal and data to the smart phone, laptop and computer and also to the physician&#39;s office as well as other health providing organizations such as hospitals and health centers. The alarm can be a sound, light (flashing or pulsating) or vibrating and any combination of the aforementioned. 
         [0016]    Usually diabetics for measuring their blood glucose level, need three separate components i.e. lancet device, test strip and glucose meter. One of the features and advantages of this invention is that it is very compact (three in one) device, simple and available in usage (in every place and situation). MGW is designed to be handheld and wearable in the form of a wristwatch and always is attached to the user. Because of this feature, the process of blood glucose monitoring becomes less time consuming and very user friendly. 
         [0017]    In each blood glucose monitoring, there is no need to insert a new electric current test strip into the test strip holder and to discard it after each measurement. 
         [0018]    In another aspect of this invention, the feature of “not to attract the attention of others” is secured. Every diabetic likes to preserve his/her privacy during measuring the blood glucose level. So shaping the glucose meter as a wristwatch makes this “control” very convenient and easy and not attractive to others. It is also noteworthy that each components of the MGW has a specific function and is playing a role in the monitoring process. For example the strap of the MGW is a holder of the strips, and the fix watch clasp functions as a lancing device and so on. This feature enables the design to become as compact as possible. 
         [0019]    Another remarkable aspect of this invention is that it does not expel the used electric current test strip out of the MGW, because the right strap of the MGW holds the used electric current test strip. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
         [0020]      FIG. 1(A)  displays a perspective view of MGW showing a watch face in a closed and shot off setting. 
           [0021]      FIG. 1( b )  displays MGW when changed into a glucose measuring face, with valve/push to slide door open, allowing access to the glucose measuring system. 
           [0022]      FIG. 2( a )-( b )  shows the different perspective views of the lancing device. 
           [0023]      FIG. 3( a )-( b )  shows the location of the silica gel inside of the lancing device. 
           [0024]      FIG. 4  shows the exploded view of the wrist-watch strap and depicts loading the new electric current test strips on the holding member and the passage of them through the left strap in order to locate the new electric current test strip in its port. 
           [0025]      FIGS. 5( a )-( b )  shows the exit of “holding member” and the used electric current test strips, out of the right strap. 
           [0026]      FIG. 6  shows the exploded view of the left strap of the MGW. 
           [0027]      FIG. 7  shows the holding member and the position of electric current test strip on it. 
           [0028]      FIG. 8  shows how the lancing device is fastened tightly to the left strap. 
       
    
    
     LIST OF PARTS 
       [0029]    Below is list of all the components of MGW as fully disclosed in detailed description:
     4  Lug/main body     5  Valve (push to slide door)     6  Holding member     7  Lancing device     8  Toggle button     9  Sampling hole     10  Lance button     11  Sampling area     12  Test strip     13  Curved shape     14  Left strap     15  Right strap     17  Jag member intervals     18  Stopper     19  Spring-Wise jags     20  Frame     21  Receiving port     22  Docket     23  Docketing roof     24  Tip of test strips     25  Magnetic layer     26  Cap     27  Silica gel packet     28  Watch clasps     29  Watch control buttons     30  Display screen     31  Opening/strip window     40  End of test strip   
 
       DETAILED DESCRIPTION 
       [0058]    The MGW, as a Smart Wristwatch, can be connected to the internet (IOT) and be equipped with GPS, wireless and Bluetooth. Taking into account that in case of hypoglycemia the patient faces the high risk of convulsion, so being tracked by his/her doctor or the emergency room is very crucial. While the patient is driving or exercising and the MGW is connected to the internet the data of blood testing is transferred immediately to the emergency room to take care of him/her timely. Another important feature of the MGW is it is capability to work as a CGM (Continuous Glucose Monitoring) device. 
         [0059]    The importance of CGM (incorporated by reference from Jin et al, 2004/186365) method is that blood glucose meters only provide a number for a single point in time, while CGM gives dynamic information and showing the fluctuation of the glucose level. 
         [0060]    Usually CGM devices comprises of three parts:
       1—A small sensor which is placed underneath the skin to measure glucose levels.   2—A transmitter which is fastened on top of the sensor and sends data to the receiver wirelessly.   3—A receiver that shows glucose trends (being normal or going up or down) in different colors.       
 
         [0064]    Therefore according to  FIG. 2( a )  lug  4  of the MGW can also function as a receiver. Lug  4  encompasses the whole body of the wrist watch including the straps. 
         [0065]    All CGM devices need calibration 2 or 4 times a day by testing blood glucose level manually. While the left strap  14  of MGW contains the electric current test strips  12 , were lug  4  works as a receiver, so the user can easily use the MGW as a manual blood glucose meter and then can instantly calibrate the receiver (lug  4 ) of the MGW. 
         [0066]    In this way screen  30  of MGW can show information such as the real-time interstitial fluid glucose level measured by a sensor (not shown. However glucose monitoring sensors are well known in the art) and draw the glucose trend and blood glucose measurements. Buttons  29  can be used to adjust the time or perform the receiver&#39;s actions. 
         [0067]    As a conclusion installing a receiver in lug  4  and matching and configuring it with the small sensor (not shown) and its related transmitter (incorporated by reference Jun et al.), the user will have a compact device including a manual meter and a continuous glucose monitoring (CGM) device which is highly portable, user friendly and exactly tailored to the diverse needs of a diabetic. 
         [0068]    The MGW can be waterproof and radiation proof. In particular the straps of the MGW can be made of plastic silicon or similar materials in order to be completely flexible and water proof. 
         [0069]      FIG. 1( a )  displays a perspective view of lug  4  with screen  30  and the closed valve/push to slide open  5  of lug  4 . When door  5  is closed the MGW is a time wristwatch and when the user opens the door  5  the MGW turns into a blood glucose wristwatch. Strap hole/opening  31  is made inside the left strap  14  through which the holding member  6  is pushed to move forward, in order to place the new electric current test strip  12  in its port. 
         [0070]      FIG. 2( a )-( b )  shows straps  14  and  15  are fastened to each other by lancing device  7 . During blood sampling the user pushes back toggle button  8  to set the lancing device  7 , then puts his/her finger on the sampling hole  9 . By pressing “lance button”  10 , needle (not shown) is triggered and pierces the skin surface of the user&#39;s fingertip. 
         [0071]    It is noteworthy that the sampling hole  9  can have a cover like a camera lens&#39; cover. By pushing a toggle button  8 , a cover of the sampling hole  9  becomes open. 
         [0072]    Lancing device  7  can have a component named “lancet drum” which contains multiple needles (not shown). Every time the lancing device  7  is used, the lancet drum is rotated and a new needle is loaded for the next test. 
         [0073]    In another embodiment the lancing device  7  by reference to U.S. Pat. No. 6,852,119 B1, incorporates only a single needle, which can be replaced with a new one manually. 
         [0074]    In another embodiment, the packing of the needle can be located in the strap of the MGW. By each test a new needle can enter the lancing device  7  from the strap, and when it is used it can be easily discarded. In another embodiment the lancing device can hold multiple sterilized lancing needles located inside the lancing device and being loaded similar to a gun and a round of bullet mechanism where, the used needle can be either discarded by means of a trigger located on a side of the lancing device and or being discarded inside in the lancing device, where a lancing needle holder rotates after each use, pulling in the used lancet and loading a new lancet ready to be pushed out for another glucose measurement when needed. 
         [0075]    According to  FIG. 1( b ) , after getting blood sample, the user opens door  5  by pressing valve lock (not shown) in the direction of the arrow counter clockwise lug  4  which changes the time wristwatch into blood glucose wristwatch. By pushing up holding member  6  through the strap opening  31  on the left strap  14 , a new electric current test strip  12  will be placed on its port (not shown). Due to the curve shape  13  of the lug  4  the end  40  of electric current test strip  12  in sampling area  11  becomes accessible. 
         [0076]    Then by touching the end  40  of electric current test strip  12  with the wounded fingertip, the blood sample is absorbed and finally within few seconds the result of the blood glucose level is shown on lug  4  of screen  30 . After ending this process there is no need to extract the used electric current test strip  12  because in the next measuring it is pushed forward through the right strap  15  and it is replaced with a new electric current test strip  12 . By closing door  5  the MGW is changed again from glucose meter into time wristwatch. 
         [0077]      FIG. 4  shows the position of the electric current test strips  12  on the holding member  6  which contains 12 to 14 electric current test strips. This holding member  6  as is shown in  FIG. 4  can easily move within the straps, from left strap  14  to right strap  15 . By pulling out the lancing device  7  from strap  14 , and pushing in the holding member  6  inside strap  14 , the holding member  6  can move and be pushed in the left strap  14 . 
         [0078]    As is visible in  FIGS. 3( a )-( b )  after pulling out the lancing device  7  from the left strap  14 , by pulling out cap  26  of the lancing device  7 , a silica gel packet  27  will be placed inside the lancing device  7  to keep the electric current test strips  12  dry. 
         [0079]      FIG. 5( a )  shows how holding member  6 , which contains the used electric current test strips  12 , can be extracted and removed from the right strap  15 . 
         [0080]    According to the  FIG. 5( b )  by opening the extract cap  16  of the right strap  15 , the tip of the holding member  6  exiting from right strap  15 , becomes accessible. By holding this tip, the holding member  6  can be completely removed from the right strap  15 . 
         [0081]      FIG. 6  shows the exploding view of the left strap  14 . Stopper  18 , which has spring-wise jags  19 , is positioned above the holding member  6  inside the strap  15 . When the stopper  18  is fixed above the holding member  6 , each jag  19  stops the holding member  6  to move back from right to left. 
         [0082]    As is visible in  FIG. 6 , opening  31  is made on the left strap  14  in order to push forward the holding member  6  through lug  4  and the right strap  15 . This movement takes place strip by strip, due to the function of the stopper  18 . Because the spring-wise jags  19  of stopper  18  falls between the jags  17  of the holding member  6 . A counter can be implemented next to opening  31  in order to display the number of test strips used, or to display the number of test strips remaining inside lug  4 . Jag intervals  17  may also have numbers or letters hacked and marked on them so that it can be clearly shown through opening  31 , informing the user about the number of test strips used or remaining. It is obvious that the letters or numbers can be in ascending or descending order, giving different information (number of test strips used or number of test strips remaining respectively). 
         [0083]    According to  FIG. 7 , the holding member  6  shows 12-14 frames  20 . Frame numbers  1 ,  2  and  3  do not contain any electric current test strip  12 . But each of the frame numbers  4  to  12 , have an opening (receiving port)  21  through which the electric current test strips  12  can be placed inside the holding member  6 . 
         [0084]    The reason that frame numbers  1 ,  2  and  3  do not contain any electric current test strip  12  is that the distance between strap hole opening  31  and the test strip port (not shown) or sampling area  11  is exactly the same as the length of these three frames and therefore the holding member  6  cannot be pushed forward any more within opening  31 ; and even if those frames did contain electric current test strip  12 , those electric current test strip  12  could not be placed on the test strip port (not shown) or sampling area  11 . 
         [0085]    As is shown in  FIG. 8  when the electric current test strip  12  is placed inside the holding member  6 , a beginning (tip)  24  of the electric current test strip  12  which has electrodes will be located on docket  22  of holding member  6  (in docket  22  of holding member  6  the test strip  12  is not covered), in order to be in touch with the measuring contact (not shown) in the test strip port (not shown). 
         [0086]    Two types of holding member  6  can be produced. One type is a disposable holding member which should be discarded after using its last electric current test strip  12 . The other type is that the holding member can be used as a prepackaged test strip cartridge, where the electric current test strips  12  are already loaded. In a different embodiment holding member  6  can be loaded manually with test strip  12 . 
         [0087]    As shown in  FIG. 8  the left strap  14  is connected to the lancing device  7  by a magnetic layer  25 . In addition to this magnetic  25  layer, for the safety and durability of the connection, two clasps  28  fasten the left strap  14  to the lancing device  7 . 
         [0088]    It is understood that the above described description and drawings are illustration of the present invention and that changes may be made in materials, lancing device, triggers, closing and stopping means and loading mechanism without departing from the scope of the present invention as defined in the following claims: