Abstract:
A handheld medical device is configured to illuminate a test strip inserted therein and may include a housing having a port configured to receive a test strip. A circuit board may be mounted inside the housing. A measurement module may be mounted to the circuit board and may be cooperatively operable with the test strip inserted into the port to measure a sample of fluid residing on the test strip. The circuit board faces an opposing top surface of the test strip inserted into the port. A light source may be mounted on the circuit board and operable to emit light substantially perpendicular to the opposing top surface of the test strip inserted into the port. The light source may project the light along an optical axis substantially perpendicular to the opposing top surface of the test strip and illuminate an area surrounding a dosing end of the test strip.

Description:
FIELD 
       [0001]    The present disclosure relates to a handheld diabetes managing device and, more particularly, relates to a handheld diabetes managing device with a light system for enhanced illumination of a test strip and an area proximate to the test strip. 
       BACKGROUND 
       [0002]    Diabetes mellitus, often referred to as diabetes, is a chronic condition in which a person has elevated blood glucose levels that result from defects in the body&#39;s ability to produce and/or use insulin. Diabetes is managed primarily by determining and controlling the level of glucose in the bloodstream. 
         [0003]    Blood glucose diagnostic information is typically obtained from a capillary blood sample with a lancing device and is then measured with a handheld blood glucose meter. There are times in which the diabetes patient may wish to perform personal glucose testing in low light conditions. For instance, the patient may want to perform the test in a dark or poorly lit room. Because the test requires a certain amount of precision (e.g., proper placement of a blood droplet on the dosing area of a test strip), it can be difficult to complete the test in such conditions. Known handheld diabetes management devices providing illumination in such situations are not capable of providing all of the capabilities of illuminating the insertion location of a test strip, and a dosing location on the test strip. 
         [0004]    Further, known handheld diabetes management devices are limited in areas that can support a light source for such illumination. Often light must be directed through an interior of the handheld diabetes management device in a light pipe before illuminating the test strip. The light pipe adds size, weight and cost to the device. 
         [0005]    This section provides background information related to the present disclosure which is not necessarily prior art. 
       SUMMARY 
       [0006]    This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features. 
         [0007]    A handheld diabetes management device for providing enhanced illumination on a dosing area of a diabetes test element is disclosed. The diabetes management device includes a housing receiving a test strip through a port in the housing. A circuit board is mounted inside the housing and faces an opposing top surface of the test strip. A measurement module is mounted to the circuit board and is cooperatively operable with the test strip inserted into the port to measure a sample of fluid residing on the test strip. A light source is mounted on the circuit board and is operable to emit light substantially perpendicular to the opposing top surface of the test strip. The light source projects the light along an optical axis substantially perpendicular to the opposing top surface of the test strip and illuminates an area surrounding a dosing end of the test strip. 
         [0008]    According to other aspects, a handheld diabetes management device includes a housing. A strip connector is positioned within the housing and is configured to receive a test element. A circuit board having a first side and a second side is mounted inside the housing. A measurement module is positioned proximate to the strip connector and is mounted to the first side. A light source is mounted on the first side and is operable to emit photons substantially perpendicular to the top surface of the test element. A first layer of the test element receives and transmits the photons along a length of the test element, discharging the photons at a dosing area. 
         [0009]    Moreover, a method of providing test strip illumination is disclosed. The method includes slitting a sheet of material to form first and second ends of a test strip, such that a light path is not altered when passed through the first or second end; cutting the slit portions of material to form first and second sides of the test strip, such that the sides include micro serrations; passing a light beam through a top side of the test strip at an optical axis perpendicular the top side; and transmitting the light beam through the test strip to illuminate an area surrounding a dosing area of the test strip, wherein the first and second ends create a constructive interference of the light beam in a length-wise direction and the first and second sides create a destructive interference of the light beam in a width-wise direction, channeling the light beam through a center of the test strip and toward the dosing area. 
         [0010]    Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. 
     
    
     
       DRAWINGS 
         [0011]    The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure. 
           [0012]      FIG. 1  is a perspective view of a handheld diabetes managing device according to the present disclosure; 
           [0013]      FIG. 2  is a perspective view of the handheld diabetes managing device of  FIG. 1  depicting light exiting a strip port when a test strip is not present; 
           [0014]      FIG. 3  is a block diagram of an exemplary hardware arrangement for the handheld diabetes managing device of  FIG. 1 ; 
           [0015]      FIG. 4  is a side perspective view of the interior components of the handheld diabetes managing device of  FIG. 1 ; 
           [0016]      FIG. 5  is a side view of a test strip according to the present disclosure; 
           [0017]      FIG. 6  is a flow chart illustrating a method for illuminating a dosing area of a test strip; and 
           [0018]      FIG. 7  is a flow chart illustrating a method for manufacturing a test strip. 
       
    
    
       [0019]    Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. 
       DETAILED DESCRIPTION 
       [0020]    Example embodiments will now be described more fully with reference to the accompanying drawings. 
         [0021]    Referring initially to  FIGS. 1 and 2 , an example embodiment of a portable, handheld diabetes management device  10  is illustrated according to the present teachings. Diabetes management device  10  includes a housing  14  sized to fit in a hand of a user, and includes a view port or screen  18  which provides digital test results and provides for user input. An access port, or strip port,  22  positioned at a body end  26 , slidably receives a test strip, or test element,  30 , which is discussed in further detail below. Test strip  30  is slidably inserted in access port  22  in an insertion direction “A” for testing, and is slidably removed in an opposite removal direction “B” at the conclusion of testing. Device  10  provides an internal light source which is capable of illuminating test strip  30 . With test strip  30  in a test position, light is emitted from a perimeter edge/dosing area  34  such that a dose/sample  38  of a bodily fluid from a user  42 , such as on the user&#39;s finger, is illuminated, as well as a general area proximate to body end  26  of housing  14 . 
         [0022]    Device  10  may be used for analyzing a body fluid disposed on edge/dosing area  34 . For instance, as will be discussed, test strip  30  can be a disposable glucose test strip of the type discussed below. In the example embodiment, a droplet of blood is applied from dose/sample  38  while test strip  30  is inserted within device  10 , and device  10  analyzes the droplet to detect a blood glucose level therein. In an alternative embodiment, the body fluid is applied from dose/sample  38  while test strip  30  is removed from device  10  and then inserted into device  10  for analysis. It will be appreciated that while device  10  analyzes blood in the example embodiment, in alternative embodiments, device  10  could be used for analyzing any other suitable characteristic of any other body fluid without departing from the scope of the present disclosure. 
         [0023]    Referring specifically to  FIG. 2 , device  10  can include first and second portions  46 ,  50  of housing  14 . First and second portions  46 ,  50  can be removably coupled together such that first and second portions  46 ,  50  define an interior space there-between, which is used to house various components therein, as will be discussed below. When test strip  30  is not positioned in access port  22 , light generated from within housing  14  is emitted through access port  22  to illuminate the area about body end  26 , which also is effective in low light areas to assist the user in aligning test strip  30  and/or to improve visibility of the area at dose/sample  38 . In the example embodiment, access port  22  is a through-hole with an ovate or rectangular shape extending through body end  26  of first portion  46  of housing  14 . However, in other embodiments, access port  22  may be a through-hole with an ovate or rectangular shape extending through second portion  50 . 
         [0024]      FIG. 3  depicts an exemplary hardware arrangement for device  10 . Device  10  is comprised generally of a measurement engine  54 , a processing subsystem  58  and a communication subsystem  62 . Each of these components is further described below. While the primary components are discussed herein, it is understood that other components (e.g., batteries or a power source) may be needed for the overall operation of device  10 . 
         [0025]    Measurement engine  54  cooperatively interacts with test strip  30  inserted into access port  22  to determine the glucose measure from sample  38  on test strip  30 . Measurement engine  54  may include calibration information for test strips  30  being read by device  10 . Measurement engine  54  may refer to, be part of, or include, an application Specific Integrated Circuit (ASIC); an electronic circuit; a combinational logic circuit; a field programmable gate array (FPGA); a processor (shared, dedicated, or group) that executes code; other suitable components that provide the described functionality; or a combination of some or all of the above. Measurement engine  54  may further include memory that stores code executed by the processor, where code, as used above, may include software, firmware, and/or microcode, and may refer to programs, routines, functions, classes, and/or objects. 
         [0026]    Processing subsystem  58  is configured to receive the glucose measures from measurement engine  54  which may in turn be stored in memory by processing subsystem  58 . Glucose measures may also be displayed by processing subsystem  58  on display  18 . The user can interact with device  10  using various user interface components, such as buttons, switches, a speaker, a microphone, USB port, etc. Each of these components is interfaced with processing subsystem  58 . In an exemplary embodiment, processing subsystem  58  includes a microprocessor  66  and one or more volatile and/or non-volatile memories  70 , although other implementations are envisioned for the processing subsystem. 
         [0027]    Processing subsystem  58  is also interfaced with communication subsystem  62 . In an exemplary embodiment, communication subsystem  62  includes a wireless transceiver  74 . Wireless transceiver  74  operates to communicate the glucose measures and other data wirelessly via a data link to a remote device physically separated from device  10 . Communication subsystem  62  can also include an antenna, microcontroller, voltage and power control circuits and a flash memory device. Although a few primary components of device  10  are discussed herein, it is readily understood that other components (e.g., a power source) may be needed to implement device  10 . 
         [0028]    Referring now to  FIG. 4 , device  10  may further include a circuit board  78  having a top side  82  and a bottom side  86 . In the example embodiment, circuit board  78  may be a printed circuit board with various circuits and circuit components included thereon. Measurement engine  54  or other components from the processing subsystem  58  may be included on circuit board  78  and may control the internal components. 
         [0029]    In the example embodiment, a light source  90  is mounted to circuit board  78 . Light source  90  can be of any suitable type, such as a light emitting diode (LED). Light source  90  is mounted to the same side of circuit board  78  as the measurement engine  54  (i.e., bottom side  86  of circuit board  78 ). In an alternative embodiment, light source  90  may be mounted to top side  82  of circuit board  78 . In still another embodiment, light source  90  may be mounted separate from circuit board  78  and connected to circuit board  78 . 
         [0030]    In the example embodiment, light source  90  is positioned approximately 0.0001 and 0.001 inches from a first surface  94  of test strip  30  when test strip  30  is in the testing position. The closer light source  90  is positioned to first surface  94 , the better the transmission of light through test strip  30 . In alternative embodiments, light source  90  may be in contact with first surface  94 . Since light source  90  is positioned to emit light directly on to test strip  30 , no alignment of light source  90  with respect to test strip  30  is necessary. Further, there is no need for additional apparatuses to direct light to a location on test strip  30 . 
         [0031]    Measurement engine  54  can be of a known type for analyzing body fluid applied to test strip  30  as discussed above. Measurement engine  54  can be operably mounted to circuit board  78  and can communicate with access port  22 . As such, when test strip  30  is inserted within access port  22  and body fluid is applied, measurement engine  54  can perform the predetermined analysis. Moreover, measurement engine  54  may include associated software and logic for performing and controlling the analysis of the body fluid. 
         [0032]    During operation, as shown in  FIG. 6  with additional reference to  FIGS. 4 and 5 , at  100 , test strip  30  is received within measurement engine  54  and abuts an exterior wall  104  of measurement engine  54 . At  108 , light from light source  90  is emitted toward test strip  30  in a direction E which is oriented within a range of incident rays E 1  to E 2  defining an angular range alpha (α) from zero degrees or normal to approximately 45 degrees measured with respect to incident ray E 1 . In the example embodiment of  FIG. 3 , direction E is substantially perpendicular (for example, within 5 degrees of perpendicular) to first surface  94 , such that the light is emitted directly onto first surface  94  of test strip  30 . In alternative embodiments, light source  90  may emit light at an angle between zero and forty degrees from the perpendicular towards dosing area  34 . By emitting the light at an angle, the efficiency of the light transmission through the strip may be improved; however, the mounting angle of light source  90  may need to be modified. 
         [0033]    At  112 , first surface  94  receives the light traveling in direction E. In some embodiments, first surface  94  may scatter the light from the original light beam. In other embodiments, first surface  94  may alter the path of the light from direction E. Test strip  30  receives the light and transmits the light in a first direction D 1  toward a reflecting surface  114 . At  116 , the light reflects from reflecting surface  120  and is redirected toward a second direction D 2  (shown in  FIG. 5 ). The second direction D 2  may be at a nonzero angle θ relative to the first direction D 1 . For the example embodiment, the angle θ may be approximately ninety degrees (90°). In other embodiments, the angle θ may be greater than or less than ninety degrees (90°) depending on reflection properties of the material. Once the light is redirected toward the second direction D 2 , the light reflects between reflecting surface  114  and first surface  94 , traveling along a longitudinal axis XYZ through test strip  30  and out a distal end  120  of test strip  30  at  124 . Thus, test strip  30  efficiently transmits the light generated by light source  90  out of housing  14 , through test strip  30 , to illuminate dosing area  34 . The light will exit as emitted light rays F. As such, the user more easily recognizes where to apply a blood droplet for glucose analysis, and proper application of the blood droplet to dosing area  34  is more likely. In the example embodiment, at  128 , while the light is transmitted through test strip  30  to illuminate dosing area  34 , the light is emitted through first surface  94  in a light scattering pattern to create a secondary illumination effect of an area substantially adjacent to test strip  30 . However, in alternative embodiments, the light may remain within test strip  30  and exit only at dosing area  34 . 
         [0034]    Referring specifically to  FIG. 5 , in the example embodiment test strip  30  may be a multiple layer strip having at least a longitudinal transparent layer  132  defining a first layer which is applied onto a second layer  136 . Second layer  136  is further applied to a third layer  140 . Longitudinal transparent layer  132  has a length “C” which is greater than a length of second layer  136  and less than a length “D” of third layer  140 , such that a recess at dosing area  34  is created on distal end  120  for receiving dose/sample  38 . Further, a free surface  144  having electrical contacts  148  extends beyond an end  152  of longitudinal transparent layer  132 . Free surface  144  and electrical contacts  148  are received within measurement engine  54  such that end  152  of longitudinal transparent layer  132  and second layer  136  abuts measurement engine  54 . 
         [0035]    Longitudinal transparent layer  132  is a clear, transparent, or translucent, layer and may be of any material that is clear or transparent. For example, first layer  132  may be a polyethylene layer, a glass layer, or any other material. First layer  132  may also have low reflectivity. In some embodiments, second layer  136  may be of a similar material and may act as a spacer between first layer  132  and third layer  140 . In alternative embodiments, second layer  136  may be an adhesive for securing first layer  132  to third layer  140 . Further, in still other embodiments, second layer  136  may include a reagent. Third layer  140  may contain a metal for electrodes and a reagent. In the example embodiment, at least one of second layer  136  and third layer  140  must be of an opaque material. The at least one layer of the opaque material may also be reflective to guide the light beam through test strip  30 . 
         [0036]    Now referring to  FIG. 7 , test strips  30  are manufactured such that the light beam travels in a lambertian distribution (i.e., a three-dimensional bell curve) across the width of test strip  30 , through the length of test strip  30 . At  150 , test strips  30  are formed from a rolled piece of material that is pre-stressed in one direction. A transmission angle is different in different directions, which somewhat polarizes longitudinal transparent layer  132 . At  154 , the rolled piece of material is slit across a width and along a length of a web forming ends perpendicular to first surface  94  of test strip  30 . The ends of each test strip are smooth and contain no striations to alter light paths through them. For example, the material is drawn across a blade, such that the material is parted and separated instead of sawing or removing material. The resulting cut creates constructive interference in the lengthwise direction of test strip  30 . At  158 , the slit pieces of material are cut forming edges perpendicular to first surface  94  of test strip  30 . The edges include micro serrations left on the cut edge providing for a rough edge on each side of test strip  30 . For example, the material is cut by a vertical knife edge whose travel is perpendicular to a plane of test strip  30 , thus leaving a plurality of vertical striations similar to a lenticular lens and dulling the emitted light from the side surfaces of test strip  30 . The resulting cut creates destructive interference in the width-wise direction. 
         [0037]    While, in the example embodiment, longitudinal transparent layer  132  is described as being a clear transparent layer, in alternative embodiments, longitudinal transparent layer  132  could also include a polarizing film. When the longitudinal transparent layer  132  is polarized, the light is not dispersed within the layer, but, instead, travels in a more columnized form through the length of test strip  30 , resulting in less light being dispersed along test strip  30  and more light exiting as light beam F.″ Further, in an alternative embodiment, dosing area  34  of test strip  30  may be of a light scattering texture to disperse the light beam. 
         [0038]    The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.