Body fluid testing component for analyte detection

[0001] The present invention relates to methods and devices for testing fluid analysis, and more particularly a device capable of simultaneously providing quantitative information about many analytes tested. In a preferred embodiment, the multi-analyte test device may be connected or integrated with an existing processing device, such as a personal computer (PC) or cellular processing device ("MPD"), such as a tablet PC, cell phone or palmtop.

II. Background of the invention [0002]

A. Trends in health care. Traditional healthcare services are primarily about treating the disease. However, it is becoming more and more recognized by doctors that when treating a disease will always be an important element of health care, concentration of health care should move to monitoring and maintaining a person's health before and during the onset of the disease. It is believed that healthcare costs can be reduced and quality of life can be increased by: (1) monitoring of health conditions before the onset of the disease, so that the disease can be treated earlier; and (2), persuading people to change their lifestyle in such a way as to reduce the likelihood of illness.

There are several conditions where monitoring the concentration of individual analytes in the human bloodstream is important. For example, the level of analytes such as cholesterol, glucose and lactate is an important monitoring parameter to gain knowledge of a person's overall health and to provide tools for early intervention, when appropriate, to help treat disease states early after they occur .

B. Glucose monitoring and diabetes. In 2000, 3.2 million people died of diabetes. The key to treating diabetes is maintaining the patient's appropriate glucose levels. Strict glucose control in the form of self-monitoring of blood glucose (SMBG) is considered standard care in the treatment and management of diabetes.

C. Atherosclerosis and cholesterol levels. Ischemic heart disease ("CAD") caused by atherosclerosis is the leading cause of death in the Western world and is predicted to be the leading cause of death in developing countries before 2025. In the United States, over 50 million people are candidates for drug treatment and / or diet to modify their lipid profiles, such as their "good" and "bad"

cholesterol. However, such treatments are enhanced if cholesterol levels are monitored.

D. Sports Medicine and Blood Lactate Levels. Increasing interest in recent years has developed studies on blood lactate levels, as blood lactate serves as a marker of anaerobic glucose metabolism in overtrained muscles. Lactate levels are now routinely monitored by most professional and many serious amateur runners, cyclists, and swimmers, along with people participating in many fitness and wellness programs.

E. Products Available For Monitoring Glucose Levels. A wide range of products currently exist that are fit for consumer use to monitor glucose levels. Currently, products are available from Roche Diagnostics (ACCU-CHEK® products); Bayer® (ASCENSIA brand products); Therasense® (Free-Style® products); and Lifescan® (ONE-TOUCH® products).

Typically, these products consist of self-contained meters that are used in conjunction with a blood test strip. To use these gauges, a puncture device is used that punctures a small hole in a body part with high blood flow, such as the tip of the finger. A drop of blood is collected from the hole, and placed on the test strip. On the test strip, the cellular components (e.g. red and white blood cells) from the blood are separated from the plasma component. The plasma component is reacted with one or more reagents that are deposited on this strip to cause the reagents to undergo a chemical reaction and form a reaction product. With many stripes, the reaction product is colored. The color may be correlated with the glucose level in the sample. The test strip is then "read" by the meter, usually by reflection photometry.

F. Products Available For Monitoring Glucose Levels. Several home appliances also exist to measure blood cholesterol levels. Some of these devices are operated in a similar way to the blood glucose testing devices described above. Examples of these include Cardio Chek® and CardioCHEK® professional devices, and Life Stream®, Three Minute Cholesterol Monitor.

An alternative study methodology is presented in the CholesTrac home cholesterol study. The CholesTrac test is a manual system that does not use an electronic meter. On the contrary, the person using the CholesTrac device visually compares the "color" of the reacted test analyte with the dye-containing resulting diagram to determine cholesterol levels.

G. Products Available For Monitoring Of Lactate Levels. Lactate measuring devices also exist, similar to the blood glucose and cholesterol measuring devices described above. Examples of these include ACCU-TREND® Lactate and ACCUR-SPORT® portable analyzer, along with a portable lactate analyzer from Lactate Probe.

The devices work similarly to glucose and cholesterol meters, as a drop of blood is placed on the test strip containing the reagent, which is then introduced into the meter.

H. Blood Testing Devices invented by Applicants and their Associates. Applicants and colleagues have invented several devices that can be used in blood tests. These devices include a capillary test strip for separating particles presented in Hans G. Kloepfer et al. in United States Patent Document No. 6696240 (February 24, 2004); Consolidated body fluid test device and method presented in Hans G. Kloepfer et al., United States Patent Document 2003/0109777 (June 12, 2003); and Hans G. Kloepfer et al., Method and apparatus for analyzing analytical fluid, US Patent Application Publication No. 2006/0034728, published February 16, 2006. See also Mary G. Kloepfer, US Patent Document No. 4883764 (28 November 1989).

[0003] Kloepfer et al., The '240 patent relates to a capillary strip which is used to separate solids from whole blood. The Kloepfer device separates plasma particles using a capillary gradient to move cells and plasma contained in the blood sample from a portion of the sample, blood accumulating on the strip, with the reagent containing test site. After the blood reaches the test site containing the reagent, the cellular components are removed, and only responsive plasma remains.

[0004] Kloepfer et al., The '777 publication discloses a device that contains all the single-use blood test components required to perform a blood test contained in a single, easy-to-produce uniform component that can be manufactured cheaply enough to make single use and economically viable disposal. The Kloepfer consolidated test device includes a uniform body that carries a disinfectant containing a cotton pad, a calibrable and movable lancet, a blood flow strengthening device, and a test strip.

[0005] The '292 Kloepfer application discloses a meter for use in connection with the consolidated body fluid testing device (wand test) disclosed in the' 777 Kloepfer publication. In addition to disclosing the inventive meter, the '728 Kloepfer publication also discloses improvements in wand testing that makes it easy to use with the meter.

[0006] Many improvements have been made by Applicants and associates for test strips and test wands making them more useful for performing blood tests on very small blood samples. In addition, the transparent test strip used with the test wand to allow the meter to detect blood by transmittance photometry or reflection photometry, and is not limited to the photometric reflection methods used with current meters.

[0007] Meter disclosed in '728 Kloepfer et al. has many features in common with other meters, as it includes typical components: (1) a container for receiving the test strip; (2) a photometric system, comprising a light source and a receiver for performing photometric analysis of reacted blood samples with a reagent for quantifying the amount of a particular analyte of interest; (3) a processor inside the meter for processing the results obtained by photometric analysis providing quantitative values ​​for the analyte of interest; and (4) a display for displaying the test results to the user.

[0008] In summary, the three Kloepfer references described above disclose an improved test strip and meter system that is considered by Applicants to be more convenient to operate than known systems, and that it can be used with smaller samples than known devices. Nevertheless, space for improvement still exists.

[0009] For example, improvements can be made to the meter. Currently, most of the meters used to measure blood analytes are single analyte meters that are only useful for performing the specific test for which they are designed. Current meters can be improved by providing one meter that is able to test simultaneously on a number of analytes. A particularly welcome improvement would be to provide a test strip and meter system that is capable of performing these tests from a single blood sample.

[0010] One brief introduction to current meters is that because single analyte meters are "self-contained" meters that require their own circuits and / or processing software to perform many of their functions. Therefore, the improvement of the current situation would be to provide a meter that is able to use the processing capabilities of the device, such as a cell phone, which most potential users already have, and that it contains the processing capacity to perform many of the processing tasks currently performed by the meter, in order to enable the user to reduce the number of devices that he must carry with him. In addition, adding measuring components to a mobile device should be less expensive than the cost of producing two separate devices.

[0011] Another area of ​​potential development is the provision of meters with the ability to communicate results with others, with the health service or with the user's own computer for later reproduction and storage. EP 1283023 discloses a recording medium that includes a current generating sensor circuit unit according to blood glucose level, and a control unit for calculating blood glucose data from data obtained by digital conversion of the current generated in the signal processing unit, entering the calculated data in EEPROM as memory unit, reading blood glucose data from EEPROM and transferring the same to a portable terminal, in which the recording medium is mounted, via a communication control unit. The recording medium further includes a power control unit powered from a portable terminal in which the recording medium is mounted and supplying power to various parts of the recording medium. As a result, the recording medium can be used, if mounted in the portable terminal, as a blood glucose monitoring device, and can be used in the system to provide a two-way connection between the portable terminal and the blood glucose information management server received from the portable terminal connected to the network.

[0012] WO 00/46598 discloses a system for collecting and automatically testing a sample of a fluid, for example urine, to indicate the presence of certain chemical components in the sample. The system preferably uses an assay device comprising a cup and a cap that includes at least one test strip. The device includes a built-in sample delivery mechanism, a wet-activated test strip with a sample delivered from a fluid sample. The device is configured to operate in conjunction with an electronic reader device capable of activating the sample delivery mechanism and reading the test strip response. The reader device defines a closed container for accommodating a complementary cup-shaped housing in a particular direction. The reader device includes a camera for recording the image of the test strip, an actuator for activating the sample delivery mechanism and a microprocessor / controller for controlling the camera and the actuator and image processing device.

[0013] It is an object of the present invention to provide an improved blood test system that includes one or more of the improvements described above.

III. Summary of the Invention [0014] According to the present invention, an analyte test device is disclosed in a processing portable device having a camera with a lens, and a processor for processing the image recorded by the camera. The analyte testing device includes a housing and test strip positioner. The test strip positioner positions the test strip containing the analyte adjacent to the camera lens to allow the camera to record an image of the test strip containing the analyte. The light source is placed inside the housing. The light is placed inside the housing to illuminate the test strip containing the analyte to facilitate the recording of the test strip image.

[0015] The processing software is provided to perform quantitative analyzes of at least one analyte from the recorded image and provide an output signal with quantitative analysis results.

[0016] Preferably, the transfer software is also provided for transferring the at least one recorded image and for quantitative analysis to a remote receiver.

[0017] In a preferred embodiment of the present invention, the analyte-containing test strip comprises an analyte receiving portion on which an analyte resides which has been subjected to separation and reaction with a reagent. The camera records the image of the part receiving the analyte. The analyte receiving portion may include a first analyte receiving portion comprising a first analyte reacted with a first reagent and a second analyte receiving portion comprising a second analyte reacted with a second reagent. The apparatus is positioned to record the image of each of the first and second parts of the analyte, and the software in a portable processing device is capable of performing quantitative analysis on each of the first and second analytes.

[0018] Furthermore, the housing is movably connected to the portable processing device between the test position and the rest position. In the test position, the camera lens is aimed at a portion of the test strip to allow the camera to capture an image of the test strip. In the rest position, the camera lens can record the image without interference from the housing, but at this time, the housing remains in connection with a portable processing device. In accordance with the present invention, the portable processing device includes a portable communication device, e.g. a mobile phone; and the housing can be articulated to a portable processing device to switch between the test position and the rest position. In addition, the housing may include a chamber for storing multiple test strips therein.

[0019] The analyte test device may or may be in the form of an external device that includes a cable for connection to a data port of the portable processing device; or alternatively, it can be an internal device that is enclosed within a portable processing device enclosure and is "wired connected" to the PD processor.

[0020] Preferably, the device comprises a test strip port for placing a test strip in which the analyte of interest is positioned. A light emitting device is provided to either illuminate the test field in which the analyte is placed, or alternatively, to project light on the test field. A miniaturized, digital camera having lenses and image sensors is provided to either receive the transmitted light, or alternatively to photograph an illuminated test field containing an analyte. A digital camera may either include a "still image" or a moving picture camera. A "VIDEO" type camera in motion would have the advantage of enabling the user to evaluate the reaction process and kinetics of the test procedure.

[0021] In a preferred embodiment, the digital information received through the miniaturized digital camera is then directed to the processing processor. The processor may contain a processing unit contained in the analyte test device. Alternatively, the processor of the portable processing device may be used to process the information. The display of the portable processing device is then used to display the result from the processor in a human-readable form, so that the user can read the information on the display to measure the analyte of interest.

[0022] The test strip can be designed to allow the measurement of multiple analytes simultaneously. For example, a first reagent may be provided to enable the user to determine cholesterol levels; a second reagent provided to enable the user to determine blood glucose levels; and a third reagent provided to enable the user to determine blood lactate levels.

[0023] The test strip and digital camera may be designed to allow the miniaturized digital camera to receive photometric information about each of many reagents discreetly so that the result from the digital camera can provide discrete information to the processor about each of the analytes of interest, enabling the processor to provide discrete measurements for each of the three analytes without interference from the presence of other analytes on the test strip.

[0024] One of the features of the present invention is that the test strip can be designed for use in many fields of test strips, where each strip of the test strip contains a reagent that is capable of reacting with another analyte of interest to provide a colorimetric reaction product, whose color and intensity may be correlated with the amount of analyte in the test fluid. Preferably, these multiple test fields and test results can be obtained by using one "micro" fluid sample, from about one to two microliters, placed on one test strip.

[0025] This feature has the advantage of allowing the user to use a test strip to test various analytes.

[0026] This multiple field test approach has several advantages. One of the advantages is that the user can examine multiple analytes using a single test strip and one meter. To the knowledge of the Applicants, the blood testing devices used by the consumer currently in use are single analyte devices that are capable of testing only a single analyte. As so, if a user wants to examine three analytes, they must purchase three separate test strips and three separate meters.

[0027] Another significant advantage lies in the user's ability to test these many samples using only a very small blood sample. One disadvantage for patients who perform tests themselves is the need to obtain a blood sample. In order to obtain a blood sample, the user is required to pierce body parts, for example, the tip of the finger with a lancet. Blood that bleeds from a tiny hole at the prick site is then placed on the test strip. With the present invention, the user must make only one puncture at one tissue site, and obtain only one blood sample, for testing multiple analytes, thereby reducing the potential number of times the user must stab himself.

[0028] Another feature of the present invention is that the test device is connected to an existing portable communication device. This feature has the advantage of reducing the number of devices that users need to buy and carry with them.

[0029] At the time of writing this application, portable communication devices have become ubiquitous.

[0030] Cell phones are primarily ubiquitous. A large number of the adult population in developed countries carries cell phones. Although small in size, cell phones contain a large amount of processing capacity. Some cell phones, such as the Palm Treo 600 and Treo 300 cell phones, contain a very large amount of processing capacity, as the Treo models are palmtops that contain cellular capabilities. With the large amount of processing power available in the device, which has already been distributed by most people, it seems quite wasteful to buy a separate meter that includes its own processing system.

[0031] In order to reduce this overlap, the device according to the invention uses the processing capacity of a mobile telephone (or other portable processing device). By making the test device connectable to a mobile phone, the user can carry only one device (his cell phone) with him, instead of two or more devices such as a cell phone and a test meter. In addition, by eliminating the need for separate processing equipment and meter software (as the processing equipment and telephone software can be used), the meter can probably be produced cheaper, thereby reducing costs for the end user.

[0032] Another advantage provided by the use of a portable processing device that includes the ability to communicate is that it allows the user to pass test results to others. For example, the user may use a cell phone to transfer his results to a health care provider, which can then monitor the patient's test results and thereby monitor the patient's health. In addition, results can be sent from a mobile phone to the user's computer to allow the user to use a large memory capacity of his computer to archive his test results. The transmission may take the form of a text message or graphic display and may be transmitted in the form of an e-mail message.

[0033] Another feature of the present invention is that the testing device relies on the use of reagents that cause a colorimetric reaction. This use of colorimetric reagents has several advantages. One of the advantages is that the colorimetric reagents used in the bright test field allow the use of transmittance photometry to measure the color produced in the reaction to thereby quantify the amount of analyte of interest in the test samples.

[0034] Another advantage obtained by using colorimetric measurement is that it allows the user to visualize the results, which allows the user to visually check the reliability of the device's accuracy.

[0035] Another advantage obtained by the colorimetric reaction is that it provides an image containing colors which photography can be taken by a miniaturized digital camera contained within the device. This digital image can be used for archival purposes. Alternatively, the digital information contained in the digital "photograph" may be used as information that is processed by the processor of the portable processing device to obtain a quantitative analysis of the analyte.

[0036] These and other features and advantages of the present invention will become apparent to those skilled in the art upon familiarizing themselves with the drawings and the detailed description of the preferred embodiment of the invention herein, which is the best mode of application of the invention currently seen by Applicants.

III. Brief description of the drawings [0037]

Fig. 1 is an exploded perspective view of the body fluid testing system of the present invention;

Fig. 2 is a top view of the system;

Fig. 3 is an enlarged top view of the system;

Fig. 4 is an enlarged perspective view, partly in section, of a test strip containing a test wand used with the present invention;

Fig. 5 is a top view of the system of the present invention showing a plurality of test wands connected thereto;

Fig. 6 is a greatly enlarged schematic top view of the test strip used with the test wand according to the present invention;

Fig. 7 is a schematic view of components of a test strip, light source and digital camera according to the present invention;

Fig. 8 is a perspective view with a partially detached housing of the test system meter component;

Fig. 9 is a perspective view with the housing of the test system meter component removed;

Fig. 10 is an enlarged, somewhat schematic top view showing the test wand inserted into the test strip receiver of the present invention; Fig. 11 is another top view with the present invention partially detached;

Fig. 12 is a perspective view of an alternative embodiment of the device;

Fig. 13 is an exploded plan view showing an embodiment of an alternative device for use with an alternative embodiment of MPD and a test wand;

Fig. 14 is a perspective view of a second alternative embodiment of the present invention showing the device in a two-part foldable structure as a case;

Fig. 15 is a front view of the device;

Fig. 16 is a side view of the device showing the case in its open position;

Fig. 17 is a perspective view of the device showing the case in an open position;

Fig. 18 is another perspective view showing the case in an open position from a different point of view;

Fig. 19 is a side view, partly in section of the device showing the case in a closed position;

Fig. 20 is an exploded perspective view of the device and test according to the present invention;

Fig. 21 is a front perspective view of another alternative embodiment of the invention that uses an optical path diameter that allows the image of the test strip to be recorded, even if the test strip positioner places the test strip the test strip on the normal optical path of the camera lens;

Fig. 22 is a perspective view of the embodiment of Fig. 21, wherein the face of the apparatus is "closed" to hide the number buttons; and Fig. 23 is a schematic side view of an alternative embodiment shown in Fig. 21.

IV. Detailed description [0038] The body fluid testing system 8 of the present invention is shown in the figures as composed of three basic components. These three components comprise an analytical unit 10 for testing body fluid, which can be operatively connected to a mobile processing device and preferably a mobile communication device, shown here as mobile phone 12. The third basic element is the test strip containing the test wand 14 which is similar or identical to those disclosed in Kloepfer et al. 777, and / or Kloepfer et al. 728, and which includes an test strip similar to those disclosed in Kloepfer '240 patent.

[0039] The most common mobile processing device with which the system 8 can be used are portable communication devices such as cell phones. System 8 will probably be used with cell phones 12 because the cell phone currently has three features that contribute to the profitability of the present invention. The first feature is that they generally have fairly robust processors which by programming (as by loading software to them) can enable the processing of information obtained from the analytical unit 10 to create a user-readable output signal. Some cell phones currently in use contain a very high level of processing power, and are now both programmable and perform functions far beyond the typical conversation transmission functions of cell phones. For example, the Palm® Treo® 300 and 600 models have palmtops, which also include components of a mobile phone.

[0040] The recently introduced Palm Treo 700 W has a special tool because it is capable of running Microsoft® Windows® mobile applications. Devices such as the Palm Treo 600, 650 and 700 are also equipped with a larger amount of memory, e.g., 64 meg, which can be expanded drastically by adding a flash memory card to an existing socket intended for placing such a card.

[0041] PDAs have many of the same functions as computers, they have the ability to run programs, display information, perform calculations and the like. In addition, other cell phones that currently exist have camera functionality, and thus the ability to process digital image information, along with the ability to transmit this digital image information.

[0042] The mobile telephone 12 includes a housing 18 which surrounds the electronic components of the telephone 12. The housing 18 has a front surface 20, a first side surface 22 and a second side surface 24, a first (upper) end surface 26 and a second (lower) end surface 28 . The front surface 20 includes a plurality (usually twelve) of the numeric buttons 32 that a user presses by selecting a number, as well as a plurality of function buttons 34 that a user can press in a particular order to access and perform the various functions that the telephone 12 is able to perform. The main function button, which can be designed as navigation button 36, is located between the function buttons 34 of the device shown in the drawing.

[0043] The LCD display 30 is also arranged on the front surface 20 and can display a large amount of information. In a cell phone / PDA, the LCD display can be quite large (e.g., four square inches) and can display large amounts of information. Optionally, the LCD 38 may include a touch screen that assists the user in navigating the menu and performing various functions that the telephone 12 can perform. Although not necessary, the device according to the invention preferably uses a 38-type LCD touch screen because it facilitates user operation of the device.

[0044] Data transfer port 42 is located on the bottom end surface 28. There is a wide range of data transfer ports for use in connection with current mobile devices. Many of these ports are not only used to transfer data between a device and another device (such as a computer), but are also used to transfer voltage and current to a cell phone battery charging device 12.

[0045] The testing device / analytical unit 10 includes a housing 46 that includes a cradle part 48 and a bottom part 50 containing a component. Part of the cradle 48 is intended to grip and hold the mobile phone 12 for connecting the analytical unit 10 to the telephone 12. The housing 46 is preferably made of plastic material and can be made as a "shell" consisting of two halves connected by a hinge. The edges of the housing can then be permanently connected to each other by means of sound welding (after placing the components), or they can be held together by means of a replaceable connector, such as screws, so that the user can separate the two halves of the housing, if necessary, to perform handling electronic components contained in them.

[0046] The cradle portion 48 includes a rear support 52 that is positioned adjacent the rear surface of the telephone housing 12; a first side carrier 54 that is provided for gripping the first side surface 22 of the housing 18 of the mobile phone 12; and a second side carrier 56 for gripping the second side surface 28 of the telephone housing 18 12. Each of the first and second side carrier 54, 56 may include a longitudinally projecting terminal rail 58. As clearly shown in Fig. 3, the clamp rail 58 is positioned to allow a corresponding clamp on the test wand 14A-14D to grip the clamp rail 58. Thanks to this ability of the test wand 14 to grip on the 58 rail, the user can wear multiple 14A-14D test wands on their cell phones. This ability to wear multiple 14A-14D test wands is very important for people who either travel and they must wear several wands for testing 14 with them, or those who need to check their blood many times a day.

[0047] The part 50 comprising the analytical unit 10 comprises a top surface comprising a plurality of operating buttons, together with a function button 70, and a main or navigation button 72. By pressing one or a combination of function buttons 70 and navigation 72, the user can control the operation of the device. The housing 46 of the analytical unit 10 also includes a first telephone end face 74 which is intended to be connected to the lower end face 28 of the telephone 12. The axially extending plug 76 extends axially outwardly with the first telephone end face 74 and is designed and adapted to coupling with the data port 42 of the telephone 12. The housing 46 also includes a second wand coupling end surface 80 that includes port 82 for positioning the test wand.

[0048] The port for placing the test wand 82 is dimensioned and configured to receive and properly position the test strip 84 (Fig. 4), which is attached to the test strip holder 86, which is formed as part of the test wand 14. The test wand insertion port 82 serves as the test strip positioner, which is intended to position the test strip 84 in the correct direction to ensure that the test strip 84 is correctly inserted into the meter 12. The test strip 84 is appropriately oriented in the analytical unit 10 when the larger plane of the test strip 84 is substantially perpendicular to the plane of the upper surface 68 of the meter 10, so that the apparatus of the device can capture an image of the analyte containing a portion of the test strip 84.

[0049] As best shown in Fig. 4, the test strip 84 is located at the end of the test wand 14, and includes an analyte placement part for receiving a suitably separated body fluid which is reacted with a suitable reagent. However, hinge 90 hinges the pressure cap 88 to the same end of the test wand 14 so that when not in use, the pressure cap 88 can cover the end of the test strip 84 to prevent contamination or contamination of the test strip 84. The way pressure cap 88 is used, and how the test wand 14 is made is discussed in more detail in Kloepfer '777 and' 728 publications.

[0050] As best shown in Figs. 8-11, meter components 12 include a printed circuit board 100 that serves both as a base on which other components are placed, as well as a communication platform to allow electronic communication between various components. The strip receiving unit 102 is centrally located on the printed circuit board 100 and is for receiving and correctly guiding the strip for test 84.

[0051] The strip receiving unit 102 has an axially extending channel 104 that receives the test strip 84 and the test strip holder 86. The axially extending channel 104 is shaped to have a portion of a vertical gap to guide the test strip 84 correctly into the test strip unit 102, so that the test strip 84 will also be positioned so that light passes through it to perform the test performed by gauge. Preferably, the main plane of test strip 84 is located in a plane perpendicular to the direction of travel by light.

[0052] A laterally extending channel 108 is also provided. The laterally extending channel 108 extends generally perpendicular to the axially extending channel 104 and intersects the channel 104 extending in the axial direction such that the two channels 104, 108 are connected to each other. The primary purpose of the laterally extending channel 108 is to provide a channel for light waves traveling along the light path 122, which light waves are emitted by a light source such as LED 114 and are received by a digital camera 124.

[0053] The light source component of the analytical unit 10 includes a light source control system 112 that is provided to control the operation of the light source 114. As mentioned above, the light source 114 preferably includes LED type light. The LED light source 114 emits light rays that can travel on the scattering glass or plate 120 located in the laterally extending channel 104 to ensure uniform light distribution through test strip 84.

[0054] A miniaturized digital camera 124 is provided to record a digital image from the reagent reaction products on test strip 84. The digital camera 124 includes a lens, such as lens 126, and an image sensor for receiving signals, together with signal processing software for signal processing. in a digital image. The image recorded by a digital camera may be a "photo", or it may be representative of light intensity signals, wavelength ("color") or other parameter useful for measuring the concentration of analyte of interest in the reagent reaction product in the part for placing analyte of test strip 84.

[0055] As with most digital cameras, the digital camera 124 of the present invention can use CCDs (multiple photosensitive array) to capture the image of the test strip. CCD is a sensor for recording images that occurs in digital photography and astronomy and consists of an integrated circuit containing a series of connected or connected capacitors. Under the control of an external circuit, each capacitor can transfer its electric charge to one or the other of its neighbors.

[0056] Digital color cameras usually use a Bayer mask over the CCD. Each square of four pixels has one filtered red, one blue and two green (the human eye is more sensitive to green than red or blue). The result is that the luminance information is collected on each pixel and the color resolution is less than the luminance resolution. Better color separation can be achieved with three-CCD (3CCD) devices and a dichroic prism beam splitter that divides the image into red, green and blue components. Each of the three CCDs is adapted to respond to a given color. Some semi-professional digital video cameras (and all professionals) use this technique.

[0057] The device 8 shown in the figures can operate via a transmission mode, the light emitted by the LED 114 being transmitted in a straight line from the test strip to the video receptor 130 of the digital camera 124. Alternatively, the device may be designed to operate in reflection mode, with the LED light source, test strips and video receptor forming an oblique path of light, so that the video receptor (lens) captures an image of the light emitted from the light source that is reflected from surface of the test strip.

[0058] One of the most important features of the light 114 and the apparatus 124 used in the analytical unit 10 is that they provide adjustable ambient light in the housing, where a repetitive and sufficient amount of light shines on the test strip 84. By incorporating the light 114 and camera elements 124 inside casings, interference from external light sources such as light in the room, sun, etc. can be eliminated, thus helping to strengthen the repeatability and accuracy of the tests carried out by the device.

[0059] Turning now to Figs. 6 and 7, the test strip 84 includes a backing element 138 having an upper surface 140 in which a sample movement path is formed. The sample movement path includes a sample placement area 142 that is dimensioned and positioned to receive a drop of body fluid such as blood from a patient. As described in more detail in the references described above, Kloepfer et al., The capillary channel 146 is positioned to separate plasma components from cellular components, such as red and white blood cells. Cells usually need to be separated from the blood in order to obtain an appropriate colorimetric reaction that does not contain interfering colors caused by colored blood components such as red and white blood cells.

[0060] The capillary channel includes a test area 150 that includes an analyte placement part 150 on which reagent strips 154, 156, 158 are placed, and an excess collection area 148 that is located downstream of the analyte placement part 150 for collecting excess fluid to ensure that only the right amount of fluid remains in the analyte 150 insertion part. As mentioned herein, the blood sample is placed in the sampling area 142 and flows in the direction of the arrow

BF, through capillary portion 144, wherein the cellular components are preserved. In the test area, the plasma fluid reacts with the reagents located on the reagent strips 154, 156, 158.

[0061] First 154, second 156 and third 158 of the reagent strips, each of which may contain a different reagent for testing a different analyte. For example, the first reagent 154 may be a reagent designed to elicit a quantitative colorimetric reaction from the first analyte of interest, such as blood glucose levels. Similarly, the second reagent 156 may be a reagent designed to detect the presence of a second analyte of interest, for example, as blood cholesterol levels, and the third reagent may be designed to detect a third analyte of interest, such as blood lactate levels.

[0062] Alternatively, each of the first, second and third of the reagent strips 154, 156, 158, respectively, may be the same reagent for determining the same analyte of interest. In this case, three reagent strips can be used to provide mutual support, or allow the user to average the values ​​determined by the colorimetric reaction generated by each of the three reagents.

[0063] Although the test strip 84 is shown as having first, second and third 154, 156, 158 reagent strips, it should also be noted that more than three or less than three reagent strips can be used to test larger or smaller number of analytes of interest. Surprisingly, applicants have found that the width of the reagent strip can be reduced to about 1 mm, while providing adequate surface, so that a digital camera or other sensor will be able to receive sufficient appropriate information to provide reliable test strips.

[0064] It should also be noted that although the reagents are currently depicted as "reagent strips" 154, 156, 158, the shape and size of the target reagents may vary. For example, reagent "strips" can be replaced by multiple reagent "dots".

[0065] An alternative embodiment of the blood test system 200 is shown in Figs. 12 and 13. The test system 200 is practically identical to the test system 10. The main difference between them is that the blood test device 204 has a different shape the housing and the other shape of the 210 data port plug to better fit the specific 202 cell phone model shown in the figures. It should also be noted that the housing of the test device 204 does not include the lateral rail structures or the rear housing support structure shown in Figs. 1-11.

[0066] The blood testing device (analytical unit) 204 includes an upper surface 208 that may or may not include a series of function buttons. Function buttons can be eliminated if the device is designed so that simply connecting the plug 210 to the data receiving port 212 activates the telephone 202 to recognize the analytical unit 204, and to display operational information on the LCD screen. In this case, the operation of the analytical unit 204 is controlled by the numeric button 216 and the function buttons 218 of the cell phone. Blood test device 202 also includes a wand receiving port 214 to place test strip 84 for testing wand 14.

[0067] A second alternative embodiment of the flap type blood test device 300 is shown in Figs. 14-20. The test apparatus 300 includes a telephone part 302 and a analytical unit 304. The telephone part 302 is pivotally connected to the housing 305 of the analytical unit part 304 via hinge 306.

[0068] The telephone portion 302 is substantially similar to the mobile phones described above in that it includes a front surface 307 having an LCD display 310 thereon. Telephone 302 also includes a number of numeric keys 312 and one or more function buttons 314 that serve the same purposes as in the embodiments described above. Part of the 302 phone also includes a back surface 316. One of the elements contained in the part of the 302 phone that is not described in relation to the phones discussed above is the camera lens 320, which is located on the back surface of the 316. The camera lens 316 is a type similar to those that currently exist in the camera contained in mobile phones . The 320 lens and the built-in digital camera included in the 302 phone are used in existing phones to allow the phone owner to use the user's mobile phone to take pictures with friends, and whatever else he may desire.

[0069] One of the unique features of the embodiment of the device 300 shown in Fig. 1420 is that the lens 320 and the camera included in the telephone 302 are also useful for the body fluid testing system for taking a "photo" of the test strip containing the analyte, measuring one or more analytes of interest that have been tested in the test strip.

[0070] As best shown in Fig. 19, the lens 320 focuses light on the photo receptor 322 contained within the phone portion 302. The photo receptor 322 is coupled to an image processing system 324 that is capable of processing the digital image obtained by the 322 photo receptor . As discussed in more detail in connection with the embodiments described above, the telephone "processing" component 302 may include a separate circuit, or rely on existing telephone or apparatus circuits. In addition, the telephone processor 302 may include software that is run on the telephone processor 302, which may be adapted to perform the analyte test of the present invention.

[0071] As best shown in Figs. 17 and 18, the phone housing part 302 includes a projection 332 that can engage the projection 330 of the housing part 304 of the analytical unit, so that the two parts can be placed in the "closed" or "test" position, as shown in Figs. 14, 19, and 20. The latch element (not shown) and the release button (not shown) can be used to properly latch the two parts 302, 304 together, and release the connection between the two parts 302, 304. When the release button is activated to release the latch element, the phone part 302 and part of the analytical unit 304 can be moved around the hinge 306 in an "open" or "non-test" position similar to that shown in Figs. 16, 17 and 18. When the housing is in the non-testing or open position, the camera lens 320 becomes obscured by the housing 305 part of the analytical unit 304, thus allowing the camera to take pictures without interfering with the housing. In this position, for example, a picture of a friend can be taken and the housing will not become part of this picture.

[0072] A portion of the analytical unit 304 of the housing 305 includes a generally hollow interior 338, part of which defines a wand storage compartment 340. As shown in Fig. 17, a plurality of wands 14 can be stored in a wand storage compartment 340 to be ready to use when the user so wishes. [0073] Lens 342 which includes light exit 344, light source 346 and strap holder 348 for testing is placed in a hollow interior 338. The light exit port 344 is arranged to be opposite the lens 320, such that the axis of the light exit port 344 is aligned with the axis of the lens 320 of the digital camera on the telephone 302 when the device 300 is in its closed position.

[0074] The device also includes a test strip holder 348 that aligns the test strip (e.g., 84) suitably in the light path LP when the test wand 14 containing the test strip is inserted into the receiving port 350 of the test wand. which is formed on the side surface of the housing of the measuring part 304. As best shown in Fig. 19, a light source 346, which may be an LED shining light up through the test strip held in the test strip holder 348. This projects the color image formed by the analyte reaction products on the strip through the light exit 344, through the lens 320, and onto the receptor photos of the 322 digital camera contained in the 302 phone. This information is then processed by the electrical circuit assembly and telephone software for information that ultimately takes the form of information relating to the occurrence or amount of analyte of interest. This information is displayed on the LCD screen 310 of the 302 telephone part. This information, together with the image, can also be saved as a file, which can then be sent as an email or "test" message to another device, such as a computer used by a healthcare center.

[0075] A third alternative embodiment of the analyte test device 400 is shown in Figs. 21-23. The testing device 400 includes part of telephone 402 and part of analytical unit 404. Part of telephone 402 is connected to housing 405 of part of analytical unit 404.

[0076] The part of the telephone 402 is substantially similar to the cell phones described above because it includes a front surface 407 having an LCD display 410 thereon. The telephone 402 also includes a number of numeric keys 412 and one or more function buttons 414 which serve the same purposes as in the embodiments described above. Part of the phone 402 also includes a back surface 416. Similar to the 302 part of the phone, the 402 part of the phone includes a camera lens 420, which is located on the back surface 416. The camera lens 420 is of a type similar to those currently found in cameras containing mobile phones. The 420 lens and the built-in digital camera included in the 402 phone are used for existing phones to allow the phone owner to use the user's mobile phone to take pictures of friends, and whatever he wants.

[0077] Similarly to telephone 302, the lens 420 and camera embedded in telephone 402 are also useful for a body fluid test system to take a "photo" of the test strip containing analyte 421 to measure one or more desired analytes that have been tested on the test strip.

[0078] Another difference between the device 400 and the device 300 is that the device 400 includes an optical unit 422 that includes a test positioner 424 that places the test strip 421 in a position that is outside of the normal optical path. As will be seen, the normal optical path of the lens is the area immediately in front of the lens. Optical unit 422 includes an optical path splitter 426 for deflecting light path 436 for test strip 421. The optical path splitter 426 includes a first mirror 428 placed at an angle of 45 ° to the light path for reflecting light at an angle of 90 °, from a generally "vertically" directed path (as shown in Fig. 23) to a "horizontally" directed path that allows light path to pass through the camera lens 420. In addition, the 426 optical path splitter includes a first lens, to focus the light path and the image shown by it.

[0079] The optical unit 422 of the analytical unit 404 includes a light source 434, such as LED, which emits light along the light path 436. The light passes through the test strip 421 which is held in the test strip positioner 424. Light emerging from the test strip 421 (which passes through it) passes through the 430 lens where it is focused. The light path 436 still extends into the reflecting mirror 428, where the light path is reflected at a 90 degree angle, so that light can pass through the camera lens 420. The light that passes through the 420 lens is captured by the CCD 440 digital camera module. This image is then taken to the 442 processor.

[0080] Processor 442 includes image processing software for image processing. In addition, the software can process the image captured by the CCD 440 module to provide a quantitative analysis of the analyte contained in the insertion part of the 421 test strip. The processor 442 can then transfer data to the cell phone transmitter part 446, which itself includes software that allows image transmission and quantitative analysis if desired to a remote source, such as another computer or other cell phone.

[0081] Having described the invention above, with respect to the currently perceived best mode of carrying out the invention, it should be understood that there are variations and modifications that fall within the scope of the invention as defined in the appended claims.

pts Diagnostics, United States Representative:

EP 1866637B1 Z-14263/14