Patent Publication Number: US-8535619-B2

Title: Blood glucose monitoring kit

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates generally to monitors for use in measuring the concentration of glucose in a blood sample (said monitors being commonly referred to as blood glucose monitors in the art). 
     There are many medical conditions which require frequent measurement of the concentration of a particular analyte in the blood of a patient. For example, diabetes is a disease which typically requires a patient to routinely measure the concentration of glucose in his/her blood. Based upon the results of each blood glucose measurement, the patient may then require a particular drug treatment (e.g., an injection of insulin) in order to regulate that the blood glucose level of the patient remains within a specified range. Exceeding the upper limit of said range (hyperglycemia) or dropping beneath the lower limit of said range (hypoglycemia) should be avoided with as much diligence as possible to prevent the patient from experiencing serious medical complications which include, inter alia, retinopathy, nephropathy, and neuropathy. 
     A multi-step process is commonly practiced by diabetes patients to self-monitor the level of glucose present in their blood. 
     In the first step of said process, a patient is required to provide a blood sample suitable for testing. Blood samples taken from a patient for blood sugar monitoring are typically obtained by piercing the skin of the patient using a lancet device. A lancet device (also commonly referred to as a lancing device) typically includes a tubular body and a removable lancet. The body is typically adapted to be held by the user, the lancet being coupled to the body and being adapted to penetrate through the epidermis (the outermost layer of the skin) of the patient and into the dermis (the layer of skin directly beneath the epidermis) which is replete with capillary beds. The puncture of one or more capillaries by the lancet generates a sample of blood which exits through the incision in the patient&#39;s skin. 
     In some lancet devices, the lancet extends from the body at all times. In other lancet devices, the lancet is adapted to be moved, when actuated, from a retracted position in which the lancet tip is disposed within the body to an extended position in which the lancet tip extends beyond the body. Typically, the movement of the lancet from its retracted position to its extended position is effected with such force that contact of the moving lancet tip with the skin of a patient results in the piercing of the skin of the patient. In many such lancet devices having a movable lancet, the lancet is automatically drawn back into the body after reaching its extended position (e.g., using a spring) in order to minimize the risk of inadvertent lancet sticks. 
     Typically, the tubular body of a lancet device is designed for multiple uses. To the contrary, each individual lancet is individually wrapped and designed for a single use. In use, the individual lancet is removed from a sealed wrapping and mounted onto the lancet body. With the lancet mounted onto the body in this manner, the lancet device can be used to acquire a blood sample. After the blood sample has been acquired, the lancet is removed from the body and is discarded. Accordingly, this type of lancet is commonly referred to as a single-use disposable lancet in the art. 
     In the second step of said process, a blood glucose monitoring system is utilized to measure the concentration of glucose in the blood sample. One type of glucose monitoring system which is well known and widely used in the art includes a blood glucose meter (also commonly referred to a blood glucose monitor) and a plurality of individual, disposable, electrochemical test sensors which can be removably loaded into the meter. Examples of blood glucose monitoring systems of this type are manufactured and sold by Abbott Laboratories under the PRECISION line of blood glucose monitoring systems. 
     Each individual electrochemical test sensor typically includes a substrate which is formed as a thin, rectangular strip of non-conductive material, such as plastic. A plurality of carbon-layer electrodes are deposited (e.g., screen printed) on the substrate along a portion of its length in a spaced apart relationship, one electrode serving as the reference electrode for the test sensor and another electrode serving as the working electrode for the test sensor. All of the conductive electrodes terminate at one end to form a reaction area for the test sensor. In the reaction area (also commonly referred to as the reactive area), an enzyme is deposited on the working electrode. When exposed to the enzyme, glucose present in a blood sample undergoes a chemical reaction which produces a measurable electrical response. The other ends of the electrical contacts are disposed to electrically contact associated conductors located in the blood glucose monitor, as will be described further below. 
     A blood glucose monitor is typically modular and portable in construction to facilitate its frequent handling by the patient. A blood glucose monitor often comprises a multi-function test port which is adapted to receive the test sensor in such a manner so that an electrical communication path is established therebetween. As such, an electrical reaction created by depositing a blood sample onto the reaction area of the test sensor travels along the working electrode of the test sensor and into the test port of the blood glucose monitor. Within the housing of the monitor, the test port is electrically connected to a microprocessor which controls the basic operations of the monitor. The microprocessor, in turn, is electrically connected to a memory device which is capable of storing a multiplicity of blood glucose test results. 
     In use, the blood glucose monitoring system of the type described above can be used in the following manner to measure the glucose level of a blood sample and, in turn, store the result of said measurement into memory as test data. Specifically, a disposable test sensor is unwrapped from its packaging and is inserted into the test port of the monitor. With the test sensor properly inserted into the monitor, there is established a direct electrical contact between the conductors on the test sensor and the conductors contained within the test port, thereby establishing an electrical communication path between the test sensor and the monitor. Having properly disposed the test sensor into the test port, the monitor typically displays a “ready” indication on its display. 
     The user is then required to provide a blood sample using a lancet device. Specifically, as noted above, a disposable lancet is unwrapped from its protective packaging and is loaded into a corresponding lancet device. The lancet device is then fired into the skin of the patient to provide a blood sample. 
     After lancing the skin, the patient is required to deposit one or more drops of blood from the patient&#39;s wound site onto the reaction area of the test sensor. When a sufficient quantity of blood is deposited on the reaction area of the test sensor, an electrochemical reaction occurs between glucose in the blood sample and the enzyme deposited on the working electrode which, in turn, produces an electrical current which decays exponentially over time. The decaying electrical current created through the chemical reaction between the enzyme and the glucose molecules in the blood sample, in turn, travels along the electrically conductive path established between the test sensor and the monitor and is measured by the microprocessor of the monitor. The microprocessor of the monitor, in turn, correlates the declining current to a standard numerical glucose value (e.g., using a scaling factor). The numerical glucose value calculated by the monitor is then shown on the monitor display for the patient to observe. In addition, the data associated with the particular blood glucose measurement is stored into the memory for the monitor. 
     As can be appreciated, the aforementioned method for conducting a blood glucose test necessitates the possession of a large quantity of separate components. Specifically, in order to perform a single blood glucose test using the method described above, a user is required to possess, inter alia, a reusable lancet base, a disposable lancet, a modular blood glucose monitor and a disposable test strip. 
     Diabetes patients often find it difficult to hold such a large quantity of individual test components. In fact, it has been found that patients often lose or misplace one or more the aforementioned components. As a result, the patient is often precluded from performing routine blood glucose tests which, in turn, can seriously jeopardize the health of the patient. 
     Accordingly, blood glucose monitoring kits are well known in the art. Blood glucose monitoring kits provide a patient with means for easily storing all of the components which are required to perform a test. Specifically, a blood glucose monitoring kit commonly includes an enclosable case into which all of the aforementioned components can be removably stored. As such, when a test is required, the user simply opens the case and removes the necessary components therefrom in order to perform an assay. Upon completion of the test, the reusable components are returned to the pouch and the disposable components are discarded. The pouch is then closed until such time that further testing is required. 
     Although useful in simplifying the handling of a large quantity of individual components, kits of the type described above suffer from a couple notable disadvantages. 
     As a first disadvantage, it has been found that kits of the type described above are somewhat bulky in size. In particular, the relatively large size of conventional blood glucose monitors tends to significantly increase the overall size (and, in particular, the thickness) of the kit. As a result, the patient often finds it to be considerably uncomfortable to store the kit on his/her person (e.g., in a clothing pocket) between tests, which is highly undesirable. 
     As a second disadvantage, the fact that all of the blood glucose testing components are removably stored within the case increases the number of preparatory steps that a patient must undertake prior to performing an assay. Specifically, the user must first open the case (e.g., by unzipping, unsnapping, etc.) in order to access the various components contained therein. With the case open, the user must then remove the lancet base and blood glucose monitor therefrom. Preferably, the monitor is then positioned on a flat and stable surface to facilitate its use. Next, the patient must remove a disposable lancet and a disposable test strip from the pouch. In turn, the disposable lancet and the disposable test strip must be unwrapped and installed into their corresponding tools. Only after completion of all these preparatory steps can the user perform an assay, which is highly undesirable. 
     SUMMARY OF THE INVENTION 
     It is an object of the present invention to provide a novel blood glucose monitoring kit. 
     It is another object of the present invention to provide a novel blood glucose monitoring kit which includes a case adapted to retain all of the necessary components for performing a blood glucose test. 
     It is yet another object of the present invention to provide a blood glucose monitoring kit as described above which is compact. 
     It is yet still another object of the present invention to provide a blood glucose monitoring kit as described above which has a limited number of parts, which is inexpensive to manufacture and which is easy to use. 
     Therefore, according to one feature of the present invention, there is provided a blood glucose monitoring kit comprising a case, said case comprising a layer of cushioned material, and blood glucose monitoring electronics at least partially integrated into said case. 
     Various other features and advantages will appear from the description to follow. In the description, reference is made to the accompanying drawings which form a part thereof, and in which is shown by way of illustration, various embodiments for practicing the invention. The embodiments will be described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that structural changes may be made without departing from the scope of the invention. The following detailed description is therefore, not to be taken in a limiting sense, and the scope of the present invention is best defined by the appended claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In the drawings wherein like reference numerals represent like parts: 
         FIG. 1  is a front perspective view of a blood glucose monitoring kit constructed according to the teachings of the present invention, the kit being shown with its case closed; 
         FIG. 2  is a front perspective view of the blood glucose monitoring kit shown in  FIG. 1 , the kit being shown with its case opened; 
         FIG. 3  is a rear perspective view of the blood glucose monitoring kit shown in  FIG. 1 , the kit being shown with its case opened; and 
         FIG. 4  is a front perspective view of the blood glucose monitoring electronics shown in  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to  FIGS. 1-3 , there is shown a blood glucose monitoring kit which is constructed according to the teachings of the present invention and identified generally by reference numeral  11 . 
     Blood glucose monitoring kit  11  comprises a case  13  and blood glucose monitoring electronics  15  which are integrated directly into case  13 . As will be described further below, the integration of blood glucose monitoring electronics  15  directly into case  13  serves two principal advantages: (1) to simplify the use of kit  11  in performing a blood glucose assay and (2) to reduce the overall size (i.e., bulkiness) of kit  11 . 
     Case  13  is preferably constructed in the form of a soft-sided, bi-fold wallet which can be disposed between a closed position (as shown in  FIG. 1 ) and an open position (as shown in  FIGS. 2 and 3 ). As will be described further in detail below, case  13  is specifically designed to compactly and comfortably retain all of the individual components which are required to undertake a blood glucose test. 
     Case  13  includes an outer layer  17  and an inner layer  19  which are secured together (e.g., through a sew line) about their peripheries. Additional layers are preferably disposed between outer and inner layers  17  and  19 , as will be described further in detail below. 
     Outer layer  17  is preferably constructed out of a soft, durable, water resistant, comfortable and aesthetically pleasing material (e.g., a polyester microfiber fabric, leather, rubber, nylon, etc.). Because outer layer  17  is manufactured out of a soft material (i.e., out of a non-rigid material such as plastic), case  13  is considerably comfortable to handle and wear within a traditional clothing pocket, which is a principal object of the present invention. 
     Inner layer  19  is preferably constructed out of a soft, durable and liquid resistant (i.e., non-porous) material such as nylon or rubber. As will be described further below, the various individual removable components for kit  11  are preferably retained against inner layer  19 . Because inner layer  19  is preferably constructed of a liquid resistant material, any liquids (e.g., blood, water, sterilization solutions, etc.) which are present on said components can be easily wiped off layer  17  as needed. 
     A layer of cushioned material  21  (e.g., cotton, foam, etc.) is preferably disposed between outer layer  15  and inner layer  17 . As can be appreciated, layer of cushioned material  21  serves to significantly soften the feel of case  13 , thereby rendering it more comfortable to handle and wear, which is a principal object of the present invention. 
     It should be noted that layer of cushioned material  21  is represented herein as being in the form of a separate layer of material which is disposed between outer layer  15  and inner layer  17 . However, it is to be understood that if either outer layer  15  or inner layer  17  is constructed out of an inherently cushioned material, layer cushioned material  21  could be eliminated from case  13  without departing from the spirit of the present invention. 
     In addition, a pair of spaced apart pair stiffening members  23  are disposed between layer of cushioned material  21  and inner layer  19 . Each stiffening member  23  is preferably in the form of a rectangular card which is constructed out of a cardboard material. As can be appreciated, stiffening members  23  serve to provide case  13  with the minimum level of rigidity that is required in order for case  13  to (1) maintain its shape and (2) adequately protect the individual blood glucose components retained therein. 
     It should be noted that the pair of stiffening members  23  are spaced apart so as to define a narrow area of weakness therebetween, said narrow area of weakness extending laterally across the approximate mid-point of the length of case. This narrow area of weakness created between the pair of stiffening members  23  serves as a fold  25  through which case  13  may bend or flex (i.e., to create the bi-fold design for case  13 ). Accordingly, fold  25  in case  13  serves to create an upper flap  27  and a lower flap  29  which can be either secured together (to dispose case  13  in its closed position) or spaced apart from one another (to dispose case  13  in its open position). 
     As will be described further below, inner layer  19  is provided with means for securing the individual removable test components for kit  11  thereagainst. Furthermore, by folding case  13  through fold  25  (i.e., such that upper flap  27  is drawn toward lower flap  29  as shown in  FIG. 1 ), case  13  is closed with all the individual removable components effectively trapped therein. In this manner, the individual removable components are safely retained within case  13  until their use is required, which is highly desirable 
     Means for retaining case  13  in its closed position is preferably provided. Specifically, a narrow band of material  31  is preferably affixed (e.g., sewn) onto inner layer  19  along its outer periphery, material  31  extending orthogonally out from inner layer  19 . Furthermore, a zipper  33  is secured onto the free end of band of material  31  and can be operated using a circular paddle  35 . 
     It should be noted that kit  11  is not limited to the use of zipper  33  to retain case  13  in its closed position. Rather, it is to be understood that other means for retaining case  13  in its closed position (e.g., snaps, ties, hook and pile type fasteners, etc.) could be utilized without departing from the spirit of the present invention. 
     As noted briefly above, means for retaining various removable glucose test components onto inner layer  19  of case  13  is preferably provided. Specifically, as seen most clearly in  FIG. 2 , a rectangular pouch  37  is affixed (e.g., sewn) to inner layer  19  of lower flap  29  along three of its edges. The one edge of pouch  37  which is not affixed to inner layer  19  is provided with an elastic band  39  which, in the absence of an outside force, constricts tightly against inner layer  19 . Pouch  37  is preferably constructed out of a mesh material and serves as a means for retaining small individual components (e.g., individual disposable test strips and individual disposable lancets) against inner layer  19 . Access to the components contained within pouch  37  is provided by drawing elastic band  39  substantially away from inner layer  19 . 
     In addition, an elastic band  41  is affixed (e.g., sewn) at both of its ends to inner layer  19  of upper flap  27  in a loop-type configuration. Elastic band  41  is preferably sized and shaped to hold the reusable base of a conventional lancing device (with the individual disposable lancets being retained within pouch  37 , as noted above). 
     Preferably, a reinforcement strip  43  is secured (e.g., sewn) over the outer periphery of both outer layer  17  and inner layer  19 . Reinforcement strip  43  is preferably constructed out of a strong and durable material, such as rubber, and serves to reinforce and protect the integrity of the seam joining outer layer  17  to inner layer  19 . 
     As noted briefly above, blood glucose monitoring electronics  15  are permanently integrated directly into case  13 . It should be noted that electronics  15  are integrated directly into case  13  without the traditional external plastic housing which protects conventional blood glucose monitors. As can be appreciated, integrating electronics  15  permanently into case  13  without any external plastic housing serves two distinct advantages. 
     First, the integration of electronics  15  into case without any external plastic housing serves to simplify the use of kit  11  in performing a blood glucose assay. Specifically, because electronics  15  are permanently secured into case  13 , the user is not required to withdraw a blood glucose monitor from case  13  before performing each assay. Rather, kit  11  enables a user to perform a glucose calculation with case  13  in either its open or closed positions, as will be described further below. 
     Second, the integration of electronics  15  into case without any external plastic housing serves to significantly reduce the overall size (i.e., bulkiness) of kit  11  when case  13  is closed. As a result, a user can more comfortably wear and/or hold kit  11  on his/her person between tests, which is a principal object of the present invention. 
     For purposes of simplicity, electronics  15  are described herein as being designed principally for use in the measurement of the concentration of glucose in a blood sample. However, it is to be understood that electronics  15  are not limited to the measurement of glucose in a blood sample. Rather, kit  11  could integrate the electronics for alternative types of analyte test instruments (e.g., ketone test instruments) into case  13  without departing from the spirit of the present invention. 
     Electronics  15  (shown in isolation in  FIG. 4 ) preferably includes a double sided printed circuit board (PCB)  45  on which various electrical components are mounted, as will be described below. It should be noted that printed circuit board  45  serves to electrically connect the various electrical components mounted thereon. 
     A multi-purpose test port  47  is mounted on printed circuit board  45  along one of its edges. Test port  47  is a current source sensing device which is capable of transmitting and receiving serial data. In the present embodiment, test port  47  includes a slot shaped to matingly receive and electrically connect with, inter alia, a test strip, a calibration strip, or the interface connector of a hardwire communication link. 
     A display  49  is mounted on printed circuit board  45  and is electrically connected thereto by means of a ribbon cable  51 . Display  49  is preferably in the form of a liquid crystal display (LCD) which can be used to display, inter alia, test results, user messages, and recalled information which is stored in the memory of electronics  15 . 
     A battery compartment  53  is mounted on printed circuit board  45  in electrical connection thereto. Compartment  53  is sized and shaped to receive a pair of replaceable AA-type batteries  55  which, in turn, serve as the power source for driving the operation of electronics  15 . It should be noted that electronics  15  need not derive its power from two AA-type batteries  55 . Rather, it is to be understood that electronics  15  could derive power from alternative power sources (e.g., a single coin cell battery) without departing from the spirit of the present invention. 
     Additional components which are preferably mounted onto printed circuit board  45  include, inter alia, a microprocessor (not shown) for performing the principal calculation and data management tasks for electronics  15  and memory (not shown) for retaining data processed by the microprocessor. 
     In addition, printed circuit board  45  includes a switch  57  for controlling the operative functions of electronics  15 . A circular button  59  is provided for regulating switch  57 . Specifically, the manual depression of button  59  serves to close switch  57  which, in turn, enables the user to, among other things, regulate the power state of electronics  15 , recall information stored in memory, respond to messages provided in the display and set some of the configuration control parameters. 
     Electronics  15  are disposed directly into upper flap  27  between outer layer  17  and inner layer  19 . Preferably, a rectangular window  59  is formed in upper flap  27  so as to render display  49  externally visible. Optionally, a transparent piece of plastic (not shown) may be mounted over window  59  to protect the screen for display  49 . In addition, it should be noted that electronics  15  are disposed within upper flap  27  such that battery compartment  53  protrudes through inner layer  19  (as seen most clearly in  FIG. 2 ). In this manner, batteries  55  are accessible to the user for replacement when deemed necessary. 
     Similarly, a circular opening  61  is provided in upper flap  27  so as to render button  59  externally accessible. Furthermore, a square-shaped opening  63  is provided in upper flap  27  so as to render test port  47  externally accessible. In this manner, the insertion of a test strip into test port  47 , the manual depression of button  59  in order to commence an assay and the visual display of test results on display  49  can all be achieved with case  13  configured in either its open or closed positions, thereby simplifying the use of kit  11 , which is highly desirable. 
     It should be noted that case  13  may additionally include an elongated protective patch  65  which is secured (e.g., sewn) onto the surface of outer layer  17 . Patch  65  is preferably constructed out of a strong and durable material, such as rubber, and serves to facilitate the handling of case  13 . Also, a belt loop  67  constructed out of a similar material as patch  65  is preferably secured at one end onto patch  65  along the lower flap  29 . The free end of belt loop  67  preferably releasably secures onto patch  65  (e.g., using hook and pile type fasteners) in order to create a closed loop, thereby enabling kit  11  to be worn on the belt of a patient. 
     Although not shown herein, it should be noted that case  13  could be constructed to include a protective cover. Specifically, upper flap  27  could be provided with a pivotable strip of material which can be selectively positioned over display  49 , button  59  and test port  47  when electronics  15  is not in use. Disposed as such, the strip of material would serve as both a protective cover for shielding sensitive components of electronics  15  from potentially harmful environmental elements (e.g., moisture) and a shield for disguising the relatively conspicuous (and potentially embarrassing) nature of display  49 , button  59  and test port  47 . 
     It should also be noted that kit  11  is not limited to display  49  being externally visible. Rather, it is to be understood that electronics  15  could be integrated into upper flap  27  such that display  49  is visible through a window formed in inner layer  19  rather than outer layer  17  (i.e., with display  49  visible from inside case  13  rather than outside case  13 ). Similarly, button  59  and test port  47  could be alternatively configured for access through inner layer  19  of upper flap  27 . In this manner, with case  13  disposed in its closed position, display  49 , button  59  and test port  47  would all be hidden from view and protected from potentially harmful environmental elements. 
     In use, kit  11  can be used in the following manner to monitor blood glucose levels. Specifically, kit  11  is preferably stored with case  13  configured in its closed position. As noted above, the compact nature and soft cushioned feel of case  13  renders kit  11  very easy to store and/or wear. When a blood glucose test is required, case  13  is opened by unzipping zipper  33  and pivoting upper flap  27  away from lower flap  29 . 
     With case  13  opened, the user can withdraw the reusable lancing device base (not shown) from elastic band  41  as well as a disposable lancet (not shown) from pouch  37 . The disposable lancet is then unwrapped and installed into the lancing device base, thereby rendering the lancing device ready for a subsequent skin prick. 
     Similarly, a disposable test strip (not shown) is removed from pouch  37  and unwrapped from any protective packaging. The unwrapped test strip is then inserted into the slot of test port  47  which, in turn, automatically activates (i.e., turns “on”) the glucose monitor. Furthermore, upon detecting the presence of the test strip within port  47 , the activated monitor generates a “ready” indication on display  49 . 
     Having completed the aforementioned preparatory steps, the user then uses the lancet device to acquire a blood sample. In turn, blood exiting from the patient&#39;s wound site is deposited onto the reactive area of the test strip. The blood sample then reacts with enzymes in the reactive area which, in turn, produces an electrical response in the form of a decaying electrical current. The decaying current is then converted by electronics  15  into a digital signal that is processed by the microprocessor to determine the analyte test value that corresponds to the signal. The microprocessor then stores the analyte test data in memory and simultaneously registers the analyte test value on display  49  for the patient to read. 
     Upon completion of the test, the used lancet and test strip are disposed and the lancet device base is returned to its stored position within elastic band  41 . The user can then zip case  13  back to its closed position for storage until such time that future glucose testing is desired. 
     The embodiment shown in the present invention is intended to be merely exemplary and those skilled in the art shall be able to make numerous variations and modifications to it without departing from the spirit of the present invention. All such variations and modifications are intended to be within the scope of the present invention as defined in the appended claims.