Patent Document

CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/071,625, filed May 8, 2008. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to medical devices, and more particularly to a self-injection guide tablet that provides a guide, template or grid applied directly to a body area for rotating subcutaneous injections for individuals who must administer such injections. 
         [0004]    2. Description of the Related Art 
         [0005]    Persons afflicted with diabetes and other medical conditions may receive a subcutaneous injection of medicine daily, or at some other regular interval. A subcutaneous injection, also sometimes called a “sub Q injection”, is a “shot” of medicine injected into a layer between skin and muscle. Subcutaneous injections are a relatively convenient way to deliver medication that would otherwise be absorbed too slowly or be made ineffective if taken by mouth. Examples of such medicines include insulin injections for people with diabetes, epinephrine injections for people with severe allergic reactions, and administration of low molecular weight heparin (e.g., Lovenox). 
         [0006]    It is known that only certain parts of the human body may be safely used for such self-injections without excessive discomfort or an inordinate risk of penetrating major veins or arteries. Generally, the body parts used for self-injections are on thighs, the fleshy area of the upper hips, the fleshy area of the backs of each arm, and portions of the lower abdomen. Each of these body parts has an area known as an injection area, in which a plurality subcutaneous injections may be made. However, it is also known that such injection irritates the body tissue and adjacent muscle at the point of self-injection. In fact, it may take up to two months for the skin and muscle in the injection area to heal. If another injection is made less than 5.08 centimeters, or less than two inches, to the previous injection before it is healed, a hard spot or knot will develop in the area of the injection as a result of the additional injection. 
         [0007]    It has been found that it is difficult for the self-injection user to determine which body areas have recently received an injection because the wounds caused by the injections visibly heal quickly at the surface of the skin. Also, it is difficult to tell which body injection area has been used recently until after the second injection, because a knot develops. As a result, it is not unusual for the self-injector to make double injections and have several painful knots at any one time. Thus, a self-injection guide tablet solving the aforementioned problems is desired. 
       SUMMARY OF THE INVENTION 
       [0008]    The self-injection guide tablet according to the present invention includes a template for each of the body injection areas used for self-injection. There are seven body injection areas commonly used for subcutaneous injections, including the thighs, the fleshy area of the upper hips, the fleshy area of the backs of each arm, and portions of the lower abdomen. Each of the templates has a removable guide grid with an adhesive backing in order to be peeled and mounted on one of the body injection areas used for self-injections. 
         [0009]    To guide the individual, each of the templates is marked with indicia. The indicia define a heading that includes a day of the week and a body part for receiving the self-injection. There are also indicia defining instructions for each template for placement. Thus, the individual administering a daily subcutaneous injection has, with the self-injection guide tablet, a template indicating the particular day and body injection area for each of the seven days in a week and for the seven body injection areas. 
         [0010]    To further provide guidance to the individual, each guide grid has a plurality of injection grids formed thereon. The injection grids each have indicia for distinguishing one grid from the other. Additionally, the injection grid receiving the injection is shaded or has other distinguishing features. To further assist the individual administering self-injections, when the guide grid is peeled from the template, the selected injection grid will remain on the template. Thus, the peeled guide grid, when placed on the specific body injection area, as instructed, will have a grid vacancy, serving as a template or guide, for receiving the injection. 
         [0011]    These and other features of the present invention will become readily apparent upon further review of the following specification and drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1  is an environmental, perspective view of a self-injection guide tablet according to the present invention. 
           [0013]      FIG. 2A  and  FIG. 2B  illustrate body areas for known subcutaneous injections intended for use with the present self-injection guide tablet. 
           [0014]      FIG. 3  is a perspective view of an individual first template with a first grid guide of the present self-injection guide tablet, for the left thigh injection area. 
           [0015]      FIG. 4  is a perspective view of an individual second template with a second grid guide of the present self-injection guide tablet, for the fleshy area of the left hip. 
           [0016]      FIG. 5  is a perspective view of an individual third template with a third grid guide of the present self-injection guide tablet, for the left arm fleshy part of the upper back portion. 
           [0017]      FIG. 6  is a perspective view of an individual fourth template with a fourth grid guide of the present self-injection guide tablet, for the abdomen. 
           [0018]      FIG. 7  is a perspective view of an individual fifth template with a fifth grid guide of the present self-injection guide tablet, for the right arm fleshy part of the upper back portion. 
           [0019]      FIG. 8  is a perspective view of an individual sixth template with a sixth grid guide of the present self-injection guide tablet, for the fleshy area of the right hip. 
           [0020]      FIG. 9  is a perspective view of an individual seventh template with a seventh grid guide of the present self-injection guide tablet, for the right thigh injection area. 
       
    
    
       [0021]    Similar reference characters denote corresponding features consistently throughout the attached drawings. 
       DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0022]      FIG. 1  shows a self-injection guide tablet, generally as  10  in the Figures. The self-injection guide tablet  10  includes a spine  12  and opposed upper and lower covers  14 ,  16 , respectively. The upper and lower covers  14 ,  16  may be substantially rigid to provide support for the self-injection guide tablet  10 . The spine  12  preferably has an adhesive or tape-like binding to fasten the covers  14 ,  16  together and to provide further support for the tablet  10 . Sandwiched between the covers  14 ,  16  are a plurality of templates, generally indicated as  18 , as will be explained in greater detail below, with specific reference to  FIGS. 3-9 . The templates  18  each have an adhesive backing, similar to the adhesive backing commonly found on adhesive bandages or other like materials, in order to permit easy peeling from the tablet  10  and from the self-injection areas of the body. There is also a perforation  19  extending through the tablet  10  for tearing off the templates  18 . 
         [0023]    With reference to  FIGS. 2A and 2B , there are indicated seven different common self-injection areas on a human body, which are typically utilized for subcutaneous injections. The injection areas are the left thigh  20 , the fleshy area of the upper left hip  21 , the fleshy, upper back portion of the left arm  22 , the abdomen  24 , the fleshy, upper back portion of the right arm  26 , the fleshy area of the right upper hip  27 , and the right thigh  28 . These seven body injection areas correspond to the days of a week, allowing the user to rotate through the body parts, with one body part being assigned to a corresponding day of the week. 
         [0024]    For example, on Monday, a self-injection may be performed in the body injection area of the left thigh  20 . On Tuesday, a self-injection is the performed in the body injection area of the left hip  21 . On Wednesday, the self-injection is performed in the body injection area of the left arm  22 . On Thursday, the self-injection is then given in the body injection area of the abdomen  24 . On Friday, the self-injection is performed in the body injection area of the right arm  26 . On Saturday, the self-injection is given in the body injection area of the right hip  27 . Finally, at the end of the one-week cycle, a self-injection is performed in the body injection area of the right thigh  28 , on Sunday. The process may then be repeated the following week, with a week&#39;s time being given for healing of each body part. 
         [0025]    It should be understood that the above was only a selected example, and that the sequence of days matching the body injection sites is entirely dependent upon the user, though once the sequence has been defined by the user, the tablet  10  should always have the same injection body area assigned to a particular day, thus allowing a one-week period being injections for each body part. Accordingly, by corresponding a body injection area with a particular day of the week, the user of the tablet  10  will easily remember, based upon the day of the week, where a self-injection is to be made. This eliminates repeating a self-injection in a particular body injection area during the week or week cycle. Thus, in a one-week cycle, each of the seven body injection areas  20 ,  21 ,  22 ,  24 ,  26 ,  27 , and  28  will have been injected only once and only on its particular day of the week. 
         [0026]    Each template in the tablet  10  includes a removable grid guide that is shaped to cover the particular body injection area. Additionally, each grid guide is divided into eight injection grids, numbered between one and eight. There is a unique numbering sequence to the eight injection grids, as shown in  FIG. 3-9 , as will be described in detail below. Generally, the unique numbering sequence of the injection grids is to ensure that there will be at least 5.08 centimeters, or a two-inch space, between injections. 
         [0027]    For example, on some of the guide grids, the injection grid number one is positioned catty-corner from injection grid number two, as injection grid number two is similarly catty-corner from injection grid number three (as shown in  FIG. 3 ). Injection grid number three is catty-corner from injection grid number four. Similarly, injection grid number five is positioned catty-corner from injection grid number six, and injection grid number six is catty-corner from injection grid number seven. Further, injection grid number seven is catty-corner from injection grid number eight. 
         [0028]    An alternative numbering sequence may also be assigned so as to ensure that no numbered injection grid is next to its sequentially numbered injection grid. This sequence also ensures that there is at least 5.08 centimeters, or at least two inches, between injection points. This sequence is used when the grid guide has the numbered injection grids in a row, as opposed to columns (as will be described in detail below). 
         [0029]    In  FIG. 3 , a first template is illustrated, with the first template being configured for usage with the left thigh area  20 . In the example of  FIG. 3 , area  20  has been assigned to Monday, and the following examples will be provided with each body part being assigned a sequential day from the first day of Monday, given in the example of  FIG. 3 . As noted above, the assignment of days to each body part is entirely dependent upon the user&#39;s preferences, and the assignments in  FIGS. 3-10  are shown for exemplary purposes only. 
         [0030]    The first template  30  includes indicia  32 , shown here for exemplary purposes only as “Monday—Left Thigh”, provided as a heading to guide the user. There are also instructions  34 ,  35  imprinted on the face of template  30  to indicate to the user where to place a first grid guide  36 , once it is peeled from the first template  30 . Thus, the user has the instructions  34 ,  35  readily available while using the first template  30  of the self-injection guide tablet  10 . 
         [0031]    The first grid guide  36  is preferably rectangular and includes eight injection grids, numbered one to eight, as described above. The numbering of the injection grids begins with an injection grid numbered one, preferably located in the top left corner, and indicated generally as  38 . Each of the numbered injection grids identifies one injection area for the particular injection area. 
         [0032]    The numbered injection grids are preferably formed in two columns, and the catty-corner numerical sequence described above is utilized to ensure that the injections are sequentially given for the selected body part at least 5.08 centimeters, or at least two inches, from the previous injection. A perforated edge  39  is shown at the top of template  30 , near the spine  12 , to permit removal of the first template  30  from the tablet  10 . 
         [0033]    When the user is ready to make the first injection, on Monday, the user will peel the first grid guide  36  from the first template  30  and place it 5.08 centimeters, or two inches, above the knee at the left thigh area  20 , and two inches below the groin, as noted in the printed instructions  34 ,  35 . Because the number one injection grid is placed at the knee, and the number four injection grid is positioned below the groin, the user can read the numbered injection grids during the performance of the self-injection. 
         [0034]    Additionally, as the first grid guide  36  is peeled off, the number one grid  38  (shaded in  FIG. 3 ) remains on the first template  30 . As the first grid guide  36  is placed on the left thigh area  20 , there will be an empty area, where the number one grid  38  is removed (by remaining fixed to template  30 ). The user will then perform the self-injection, within the open area of the vacated first grid. After self-injection, the first grid guide  36  is peeled off the left thigh area  20  and may be disposed of. Once the first grid guide  36  has been discarded, it obviously will not be used again in the first week, ensuring that there will not accidentally be an injection in the left thigh area  20 . Once the user has gone through a full week of templates, on the following Monday, when injection is due in the left thigh area again, the number two space of the grid guide will be vacated, and on the third week, the number three space will be vacated, etc. 
         [0035]      FIG. 4  illustrates a second template  40 . This second template  40  has indicia  42  formed thereon, forming a heading reading “Tuesday—Left Hip”, in order to guide the user. As described above, there are instructions  44  for placement of a second grid guide  46  on the left hip area  21 . The shape of the second grid guide  46  is similar to the configuration described above with regard to  FIG. 3 , with the injection grids numbered one, six, three, and eight in a first column (formed on the left on  FIG. 4 ), and a second column, having a substantially half-elliptical shape, including injection grids numbered five, two, seven, and four. Thus, the catty-corner sequence is maintained to ensure that there is at least 5.08 centimeters, or at least two inches, between successive injections in the left hip area  21 . 
         [0036]    As this is the first week cycle, the number one injection grid, indicated generally as  48  and shown being shaded, will remain on the second template  40  when the second grid guide  46  is peeled off. The second grid guide  46  is placed on the fleshy area of the upper hip  21 , below the waist, as indicated by instructions  44 . When the injection is going to be preformed, the user injects into the empty injection grid area, where the number one injection grid  48  was removed. After injection, the second grid guide  46  is peeled off and discarded. Since, the grid guide  46  has been discarded, the user will not use the template  40  again in this first week cycle and will not inject in the left hip area  21  during this first week cycle. There is also a perforated edge  49  on the template  40 , so the user may tear off the used template  40  from tablet  10 , and discard it as well. 
         [0037]      FIG. 5  shows a third template  50  of the tablet  10 . This third template  50  has the indicia  52  formed thereon, reading “Wednesday—Left Arm”, as well as instructions  54  for placement of a third grid guide  56  on the left arm area  22 . The shape of the third grid guide  56  is substantially oval with the injection grids numbered one, six, three, and eight in a first column. The second column has the injection grids numbered five, two, seven, and four. As above, the catty-corner sequence is maintained to ensure that there is at least two inches from a previous injection grid any time an injection is given on a Wednesday into the left arm area  22 . 
         [0038]    As previously noted, this is Wednesday in the first week cycle. Since, it is still the first week cycle, the number one injection grid  58  is shaded, indicating that it will remain on the third template  50  when the third grid guide  56  is peeled off. As noted above, in the second week cycle, the number two grid will remain on the template as the grid guide  56  is removed from the template, and so on. The third grid guide  56  is placed on the fleshy area of the upper back portion of the left arm  22 . The injection is preformed in the empty injection grid vacated by the number one injection grid  58 . After the self-injection, the third grid guide  56  is peeled off the left arm  22  and discarded. A perforated edge  59  is formed near the spine  12  of the tablet  10 , allowing the user to tear off the template  50  and discard it as well. 
         [0039]      FIG. 6  illustrates a fourth template  60  of the tablet  10 . This fourth template  60  has indicia  62  formed thereon, reading “Thursday—Abdomen”, as well as instructions  64  for placement of the fourth grid guide  66  on the abdomen injection area  24 . The fourth grid guide  60  has an arch shape, with only one row of injection grids, numbered in a sequence of one, five, two, six, three, seven, four and eight. Fourth template  60  includes this arcuate configuration for grid guide  66  due to the unique contouring of the abdominal area. While the catty-corner sequence is not used on this fourth grid guide  66 , this sequence still maintains at least 5.08 centimeters, or at least two inches, from a previous injection grid in the fourth grid guide  66 , because each of the sequential numbered injection grids on the fourth grid guide  66  are approximately 5.08 centimeters, or two inches, apart. 
         [0040]    As indicated previously, this is still the first-week cycle, so the number one injection grid  68  remains on the fourth template  60  when the fourth grid guide  66  is removed from the template  60 . The fourth grid guide  66 , with the number one injection grid  68  vacated, is placed on the fleshy area of the abdomen injection area  24 . As the fourth grid guide  66  is placed on the abdomen injection area  24 , the instructions  64  inform the user to avoid injection in the region about two inches around the navel. Once the self-injection is performed into the empty injection grid space vacated by the number one injection grid  68 , the fourth grid guide  66  for the abdomen area  24  is peeled off and safely discarded. With the grid guide  66  being discarded, the user will not use the template  60  in this first week cycle again, and will not inject in the abdomen area  24  during the first week cycle. A perforated edge  69  near the spine  12  of the tablet allows the user to tear off the template  60  and discard it as well. 
         [0041]      FIG. 7  shows a fifth template  70  of the tablet  10 . Fifth template  70  includes indicia  72 , forming a heading reading “Friday—Right Arm”, as well as instructions  74  for placement of the fifth grid guide  76  on the right arm injection area  26 . The shape of the fifth grid guide  76  is substantially oval to cover the right arm injection area  26 . The fifth grid guide  76  has the injection grids numbered one, six, three, and eight in the right column. The other column has the injection grids numbered five, two, seven, and four. 
         [0042]    As can be seen, the catty-corner sequencing of the numbers identifying the injection grids on the fifth grid guide  76  is used again. This catty-corner sequence ensures that no injection is made within a 5.08 centimeter, or a two inch, area from a previous injection in this right arm area  26 . Additionally, the number one injection grid, indicated generally as  78 , is in the opposite column, as opposed to the third grid guide  56  of  FIG. 5 , utilized with the left arm injection area  22 . By switching or reversing the columns of the numbered injection grids, the user, when injecting in the same vacated injection grids in each arm, will inject in a symmetrical area, with respect to the other arm. For example, the injections made in the column with the number one injection grid will be on the outside of both the left arm  22  and right arm  26 . 
         [0043]    Again, this is still the first week cycle of self-injections. Since, it is the first week cycle of self-injections, the number one grid square  78 , which is shown as being shaded, will remain on the fifth template  70  when the fifth grid guide  76  is peeled off and placed on the right arm injection area  26 . This makes it simple for the user to perform injections, since the injection is made in the vacated spot left by the number one injection grid  78 . After the self-injection, the fifth grid guide  76  is peeled off the right arm injection area  26  and conveniently discarded. With the grid guide  76  being discarded, the user will not use the template  70  again in this first week cycle, and will not inject in the right arm area  26  during the first week cycle. A perforated edge  79  near the spine  12  of the tablet  10  allows the user to tear off the template  70  and discard it. 
         [0044]    With respect to  FIG. 8 , a sixth template  80  is illustrated. This sixth template  80  has indicia  82  formed thereon, forming a heading of “Saturday—Right Hip”, as well as instructions  84  for placement of a sixth grid guide  86  on the right hip injection area  27 . The shape of the sixth grid guide  86  is symmetrical with respect to the grid guide described above for the user&#39;s left hip injection area. In the right-hand column, a number one injection grid is indicated generally by numeral  88  and is shaded. This number one injection grid  88  is in a column with the injection grids numbered six, three, and eight. The second, half-elliptical column includes the injection grids numbered five, two, seven, and four. Thus, the catty-corner sequence described above is maintained. 
         [0045]    Additionally, the number one injection grid  88  is in the opposite column compared to the second grid guide  46 , shown in  FIG. 4 , utilized with the left hip injection area  21 , as are all the numbered injection grids. By switching or reversing the columns of the numbered injection grids, the user, when injecting in the same vacated injection grids in each hip, will be in the same area of the body part; i.e., injection will be symmetrical about the center-line of the body. Since, this is still the first week cycle, the number one injection grid  88  will remain on the sixth template  80  as the sixth guide grid  86  is peeled and removed from the sixth template  80 . The sixth guide grid  86  is then placed on the fleshy area of the upper right hip injection area  27 , below the waist, as indicated by the instructions  84 . The self-injection is performed in the open space left by the number one injection grid  88  and then the sixth grid guide  86  is peeled off and appropriately discarded. A perforated edge  89  is formed near the spine  12  of the tablet  10 . 
         [0046]    With respect to  FIG. 9 , on the seventh and final day of the first cycle week, a seventh template  90  is used for a self-injection into the right thigh injection area  28 . The seventh template  90  includes indicia  92 , forming a heading of “Sunday—Right Thigh”, along with instructions  94 ,  95 , indicating to the user where to place the seventh grid guide  96  once it is peeled from the seventh template  90 . The seventh grid guide  90 , for the right thigh injection area  28 , is rectangular-shaped, similar to the first grid guide  36  for the left thigh injection area  20 . 
         [0047]    The number one injection grid  98 , however, is in the opposite column from that of the first grid guide  36  (shown in  FIG. 3 ), as are all the numbered injection grids. By switching or reversing the columns of the numbered injection grids, the user, when injecting in the same vacated injection grids in each thigh, will be in the same area of the body part, as described above. 
         [0048]    As the instructions  94 ,  95  note, the seventh grid guide  96 , after peeling from the seventh template  90 , is placed two inches above the knee and two inches below the groin so that the user can read the numbers as he or she is performing a self-injection. As the seventh grid guide  96  is peeled off the seventh template  90  for the right thigh injection area  28 , the number one injection grid  98  is shaded and remains on the template  90 . The seventh guide grid  96  is then placed on the right thigh injection area  28 , as indicated by the instructions  84 . The self-injection is made in the open space left by the number one injection grid  98  and then the seventh grid guide  96  is peeled off and discarded. A perforated edge  99  is formed near the spine  12  of the tablet, allowing the user to tear off the template  90  and discard it as well. Thus, with the grid guide  96  being discarded, the user will not use the template  90  again in this first week cycle, and will not inject in the right thigh area  28  during the first week cycle again. 
         [0049]    At this point, the week-long cycle has been completed, and the next injection is due on the next Monday, with the second week cycle to begin. The user will have used and discarded the seven grid guides  36 ,  46 ,  56 ,  66 ,  76 ,  86 , and  96  from the seven daily templates  30 ,  40 ,  50 ,  60 ,  70 ,  80 , and  90 . The user will also have performed a self-injection in each of the seven injection areas  20 ,  21 ,  22 ,  24 ,  26 ,  27 , and  28  utilizing the space vacated by the number one injection grids  38 ,  48 ,  58 ,  68 ,  78 ,  88 , and  98 . Thus, completing the first week cycle. 
         [0050]    Now, on Monday of the second week cycle, the self-injection of seven injection areas  20 ,  21 ,  22 ,  24 ,  26 ,  27 , and  28  begins again. However, in the second week cycle, each of the seven grid guides  36 ,  46 ,  56 ,  66 ,  76 ,  86 , and  96  of each of the seven templates  30 ,  40 ,  50 ,  60 ,  70 ,  80 , and  90  in the tablet  10  will have all seven of the number two injection grids shaded when the user makes a self-injection. The number one injection grids  38 ,  48 ,  58 ,  68 ,  78 ,  88 , and  98  are not shaded and are part of the respective grid guide  36 ,  46 ,  56 ,  66 ,  76 ,  86 , and  96  when peeled and placed on the respective injection areas  20 ,  21 ,  22 ,  24 ,  26 ,  27 , and  28 . Thus, the user can easily complete their daily injections for the second week. 
         [0051]    This injection cycle repeats over an eight-week cycle that corresponds to the eight numbered injection grids in each of the seven guide grids  36 ,  46 ,  56 ,  66 ,  76 ,  86 , and  96 . Thus, the tablet  10  will be completed after approximately a two-month period. Preferably, each tablet  10  is manufactured to include eight sets of the seven templates  30 ,  40 ,  50 ,  60 ,  70 ,  80 , and  90  in the tablet  10 . 
         [0052]    It should also be noted that the perforations  39 ,  49 ,  59 ,  69 ,  79 ,  89 , and  99  added to each of the templates in the tablet  10  allow the user to remove an entire template or more, if necessary. Such removal could be utilized when the user is on a trip and only needs to take a few days worth of templates for self-injections, rather than bringing the entire tablet  10 . Alternatively, the user may want to remove a respective template from the tablet  10  after using and discarding the respective grid guide. 
         [0053]    The use of an adhesive backing, such as found on adhesive bandages, does not necessarily have to cover the entire back of the template, it is only required to have enough adhesive surface area to hold a grid guide on a template, and to ensure the grid guide adheres to the body injection area long enough for the self-injection (and to be readily removable without much discomfort to the user). 
         [0054]    Additionally, the tablet can be modified for those individuals who require more than one injection per day or even for those who require between one and several injections per week. Some medications require varied injections times. For example, Rebif® requires injection three times per week, whereas Humira® requires injection only every other week. Tablet  10  may be customized to accommodate such irregular injection schedules. With respect to the numbering on the injection grids, the use of numbers one through eight is common in the medical field to identify an injection area. However, letters or other indicia could be alternatively used to guide the individual making self-injections. 
         [0055]    Furthermore, general instructions could be printed on one or both of the covers  14 ,  16 . In use, the user should wash and dry his or her hands prior to peeling the grid guide from the template. The user should then place the grid guide on the area indicated (e.g., right thigh, right hip, etc.), with the adhesive backing holding the guide in place. The user should clean the skin in the open injection grid area with an alcohol pad, or with any other suitable sanitizer, and allow the skin to dry. The self-injection is given in the open injection grid, and then gentle pressure is applied with a cotton ball or gauze to dry the open injection grid area. Finally, the entire grid guide is peeled and discarded. The user should avoid injection in areas with stretch marks, bruises, tattoos, scars, lesions, swelling, lumps, redness, or warts. 
         [0056]    It is to be understood that the present invention is not limited to the embodiment described above, but encompasses any and all embodiments within the scope of the following claims.

Technology Category: 1