Abstract:
A glucometer guide is provided to address the difficulty that blind or visually impaired diabetic patients have when attempting to independently use a glucometer. The guide provides haptic cues for the effective transfer of blood onto a test strip.

Description:
FIELD OF THE INVENTION 
       [0001]    Embodiments of the invention provide a haptic glucometer guide that allows visually-impaired patients to independently and accurately obtain blood glucose readings. 
       BACKGROUND OF THE INVENTION 
       [0002]    For a non-blind patient with diabetes, the process of taking a blood sample with a glucometer is relatively easy due to their ability to visually guide themselves through each step: choosing a place to pierce the skin, lancing that chosen point, and then ensuring that the blood gained from lancing the skin is able to be appropriately placed on a glucometer test strip. 
         [0003]    Poorly-managed diabetes can result in diabetic retinopathy which causes gradual loss of an individual&#39;s retinal field, thus there can be a correlation between diabetes and blindness. Other diabetics may be blind by other means. A blind or otherwise visually impaired diabetic can easily choose a point on their person to use as a testing site and lance that point, but a problem arises when the visually impaired diabetic is unable to find that miniscule spot again and align it properly with a small test strip so that the blood is drawn into the test strip. There are some simple methods that the blind or visually impaired diabetic can use to find the spot again, such as trying to line up the end of the test strip with the specific area based on memory, or using an ad-hoc home-made method that orients and places the test strip in the same direction that the lancet was pointed. However, those home-made and mental memory solutions do not guarantee that the blood will get to the test strip, and the use of those methods will most likely result in smearing the blood sample into the skin test site until it is either too small to use or it is impure, leading to inaccurate readings or the need for another lancet piercing. 
         [0004]    Blind or otherwise visually impaired diabetic patients often waste many test strips attempting to obtain one valid blood glucose reading. These individuals usually require assistance from others when measuring their blood glucose levels or they risk wasting expensive test strips for which only a certain amount are provided each week by insurance companies. 
         [0005]    There are devices on the market that perform both lancing and testing in an automated fashion. However these devices, such as the Gio glucometer (Eric Forman Gio glucometer), do not integrate the lancing and testing steps and rely on the user to visually guide a blood sample onto a test strip. Electronic glucose meters featuring synthesized speech, such as The Prodigy Voice Blood Glucose Meter, are intended for use by visually impaired diabetics by informing the user of the resulting numeric measurement through audio cues (U.S. patent application Ser. No. 13/547,400). However, users of these devices still cannot successfully coordinate the transfer of blood to the test strip without excessive blood drawing or external assistance. 
       SUMMARY OF THE INVENTION 
       [0006]    The haptic glucometer guide, according to embodiments of the invention, is a device that assists the blind or visually impaired subject in measuring their blood glucose levels with a glucometer. In some embodiments, the subject has diabetes. 
         [0007]    Hence, it is an object of the invention to serve in guiding the visually impaired diabetic in taking and monitoring their glucose levels without assistance from others or wasting test strips. It is an object of the invention to: (a) provide a fixed alignment and rotational angle between the finger prick created by the lancet and the test strip, (b) allow the user to then rotate the finger to place the blood drop on the test strip, and (c) provide a compartment for the attachment of a glucometer and maintain the correct positional relationship between the lancet seat and the glucometer test strip. 
         [0008]    The guide is preferably manufactured with dimensions allowing for its use with any standard glucometer. The guide facilitates the use of a glucometer for the purposes of testing blood sugar by placing the desired test site, preferably a subject&#39;s finger, onto a specified location on the guide, the top window where lancing occurs. After lancing, the user rotates the test site so that the blood will be drawn into the test strip to the glucometer. 
         [0009]    In an exemplary embodiment, the user inserts a test strip into the guide with a glucometer already secured into the device. The user then places a finger inside the cylindrical cavity and pricks their finger at the desired location via the window on the top face of the cylindrical section. The user then rotates their finger along the inside of the cylindrical section with the prick site travelling down the open window. The bead of blood makes contact with the test strip, which is positioned at the bottom of the window, and the glucometer records and communicates the results to the user. 
         [0010]    Additional features and advantages of the invention will be set forth in the description below, and in part will be apparent from the description, or may be learned by practice of the invention. The advantages of the invention can be realized and attained by the exemplary structure particularly pointed out in the written description and claims hereof as well as the appended drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1A . Isometric view of an exemplary glucometer guide illustrating the opening for the finger hole  10 , top window  20  where lancing occurs containing a raised lancet seat  25 , bottom window where the blood contacts the test strip  30 , positioning of the test strip  40 , compartment for glucometer  50  containing an opening  55  on the bottom, and a cutout for a USB port and/or audio jack  60 . 
           [0012]      FIG. 1B . Side profile view of the side of the glucometer guide of  FIG. 1A . 
           [0013]      FIG. 1C . Enlarged side view of the glucometer guide showing the finger cavity  10 . 
           [0014]      FIG. 1D . Section view of the finger cavity illustrated in  FIGS. 1A-1C . Haptic cues such as raised ridges  70 , one or more dimples (not shown) and/or a sunken area (not shown) may be positioned to provide guidance during finger rotation and to ensure that blood does not contact the glucometer. 
           [0015]      FIG. 1E . Bottom view of the haptic glucometer guide. 
       
    
    
     DETAILED DESCRIPTION 
       [0016]    Embodiments of the invention provide a glucometer guide comprising:
       a compartment for connection to a glucometer;   a cavity formed to accommodate an inserted finger of a user and permit rotation of the finger therein; and   a window in said cavity wherein the window is positioned to allow a lancet to prick the finger through the window and to allow the blood of the pricked finger to contact a test strip after rotation of the finger, wherein the test strip extends between the window in the cavity and the glucometer in the compartment.       
 
         [0020]      FIG. 1A-E  illustrate an exemplary embodiment of the haptic glucometer guide. In  FIG. 1A , the guide includes a finger hole  10  member and a compartment member  50 . The finger hole  10  is sized to accommodate the finger of a subject. In some embodiments, the finger hole will be sized for the average adult (or average adult female or average adult male), while in other embodiments, the finger hole can be sized for the average toddler, child or young adult. The finger hole  10  is preferably cylindrical or multipolygonal so that any part of the finger can be used (e.g., from distal to proximal locations and at any rotation of the finger). In addition, the finger hole  10  can be sized for easy use with any of the user&#39;s fingers. 
         [0021]    An advantage of the haptic glucometer guide is that a glucometer (not shown) can be affixed to the guide in the compartment  50  so that only one hand is required for holding the glucometer and guide. In the embodiment shown in  FIG. 1A , the compartment  50  is a depression in a plastic or ceramic housing which is sized to accommodate any of a variety of commercially available glucometers; however, it will be recognized that there are other mechanisms for connecting the guide and the glucometer. The configuration shown in  FIGS. 1A-E  would work well with the Prodigy Voice Blood Glucose Meter, a blood glucose meter intended for use by visually impaired diabetics which provides audio cues indicative of numeric measurements and other useful features for the diabetic patient; however, the haptic glucometer guide can be configured for optimal use with other glucometers and/or may be universal in character to allow use with a wide variety of gluocometers (e.g., parameters such as the size and shape of the compartment  50  can be varied and/or made adjustable). In a preferred embodiment, the haptic glucometer guide is made from thermoplastic materials (e.g,, ABS, polypropylene, etc.) and can be manufactured by three dimensional printing, injection molding, etc. 
         [0022]    In the embodiment shown in  FIG. 1A , there is a cutout opening  60  in the compartment  50  end which will allow for connecting the glucometer to a USB port, power cord, audio jack or other device. In addition, there is an opening  55  in the base of the compartment  50  (see also  FIG. 1E ). This opening  55  may serve the simple function of allowing the user to more easily push the gluocometer out of the compartment  50 . However, the opening  50  may also permit various features of the glucometer to be accessed. For example, a display, Braille provisioning port, audio output, etc. of the glucometer might be accessible through the opening  55 . 
         [0023]      FIG. 1A  illustrates an elongated opening having a top window portion  20  and a side window portion  30  in the finger hole compartment. Upon insertion of the person&#39;s finger in the finger hole  10 , a lancet can be plunged downward to a target site in the finger from which to draw blood. A lancet seat  25  can be used to help the person guide the lancet to the desired target site. Preferably the lancet seat  25  is raised above the top window portion  20  as shown in  FIG. 1A  so as to enable a blind person to more easily locate the lancet and the target site. In some embodiments, the lancet seat  25  can be adjustable to accommodate different types of lancets. Upon pricking the finger at the target site, the finger can simply be rotated, e.g., preferably 90° (but a range of, for example 45° to 135° might also be employed) so that the blood can contact a test strip (not shown) which extends from the lower window portion  30  to the glucometer in the compartment  50  at region  40 . 
         [0024]    An advantage of the haptic glucometer guide is that it allows the user to easily align test strips with the pricked target site and allows the glucometer to make the readings. This can be accomplished by having the test strip extend from the glucometer in the compartment  50  to or into the lower window portion opening  30 . A blind person (or other user of the haptic glucometer guide) can easily locate the lower window portion  30  because it is an opening in the finger hole portion of the guide (e.g., it can be located by feel). This lower window portion  30  will be aligned with the measurement portion of the glucometer. Preferably, as shown in  FIG. 1A , the region  40  is on a raised portion of the housing above the depression made from the compartment so as to support the test strip. However, further non-visual cues or alignment features can be built in at region  40  by, for example, including dimples, striations, a slight depression, a slight bulge, etc. to alert the visually impaired as to the location of region  40 . In operation, after pricking the finger at the target site, the finger is simply rolled to allow the blood to contact the test strip at region  40  so that results can be read by the glucometer. The haptic glucometer guide can therefore result in easier operation by, for example, the visually impaired (e.g., they can more easily make measurements without the assistance of others), and can result in a significant reduction in wasted test strips (thus a cost savings). 
         [0025]      FIG. 1D  (and  FIGS. 1B and 1C ) illustrate an exemplary feature of the haptic glucometer guide which aids in alignment. Specifically, in  FIG. 1D  there is shown two elongated, inwardly projecting ridges  70  on either side of the window opening. These ridges project into the finger hole  10  and can be felt by the user when locating a portion of his or her finger to be pricked by the lancet. While two ridges  70  are shown, a single ridge on one side of the window opening could be used. Alternatively, a series of dimples (inward or outwardly projecting) could be aligned with one or both sides of the window, or even a single dimple adjacent the window could be utilized. Bumps or other haptic cues may also function in the same way as the ridges  70 . 
         [0026]    Other advantages of having the guide secured to a glucometer may include providing feedback to the user when tests are successfully made. For example, a speaker in the glucometer may alert the user when the test is successfully completed as well as the results of the test (and or other information of interest), or the glucometer may be equipped with a shaker so that after the test is successfully completed the combination of the glucometer and the guide can be vibrated to let the user know that the test has been successful, etc. 
         [0027]    Embodiments of the invention also provide a method for the measurement of blood glucose in a subject comprising analyzing a blood sample with a glucometer inserted into a glucometer guide as described herein. In exemplary embodiments, the subject has diabetes. In some embodiments, the glucometer guide of the invention is used by blind or visually impaired individuals to measure their own blood glucose levels. In some embodiments, the guide is used by individuals who are not blind or visually impaired, but who would still benefit from the use of a guide as described herein, such as elderly or adolescent individuals. In some embodiments, the guide is used as a simple tool for medical practitioners or those otherwise assisting the individual to quickly and easily obtain blood glucose levels from the individual. 
         [0028]    The glucometer guide of the invention reduces the task of transferring blood to a test strip to one wrist rotation guided by haptic cues inside the cylindrical cavity  10  of the guide where the finger is placed ( FIG. 1A-D ). 
         [0029]    In some methods of the present invention, a glucometer is turned on and a test strip is inserted into the glucometer. The glucometer, with the test strip inserted, is placed into the fitted compartment  50  of the assistive device. Alternatively, the test strip may be inserted after the glucometer is fitted into the device. The test strip sits on the shelf at region  40  between the glucometer compartment  50  and the finger hole  10 . The user places a finger through either end of the circular finger hole and aligns the desired test site on their finger with the top window  20  of the circular cavity. The user then places a loaded and cocked lancet device at the top window  20  of the guide with their other hand, where the inserted finger is positioned, and then triggers the lancet device. Once pierced, the user rotates their finger 90 degrees along the open slot until they feel the test strip at the bottom window portion  30 , and slightly rotates the finger up and down while maintaining contact with the test strip until, for example, audio cues from the glucometer let the user know that the blood sample was collected and analyzed successfully. In some embodiments, although the user feels the test strip, the bead of blood, and not the finger, is what contacts the test strip. Confirmation of the sample is almost instantaneous with some glucometers and the user is given an audio cue that the user has reached the correct orientation and the sample was taken. Glucometers that are used with the guide may also use feedback other than or in combination with audio cues such as vibrotactile feedback. For example, the glucometer may vibrate when the sample has been received or analyzed. 
         [0030]    It is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims. Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention. 
         [0031]    It is noted that, as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. 
         [0032]    As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. Any recited method can be carried out in the order of events recited or in any other order which is logically possible. 
         [0033]    While the invention has been described in terms of its preferred embodiments, those skilled in the art will recognize that the invention can be practiced with modification within the spirit and scope of the appended claims. Accordingly, the present invention should not be limited to the embodiments as described above, but should further include all modifications and equivalents thereof within the spirit and scope of the description provided herein.