Abstract:
A lancing device formed from a main body and a cap. The main body is configured from a lower housing, an upper housing extending over a portion of the lower housing, and an actuator operatively engaged to the upper and lower housings with the actuator extending along the portion of the lower housing not covered by the upper housing. The upper housing further includes an actuator button, wherein a lancet may be placed within the body such that movement of the actuator from a first position to a second position away from said endcap cocks the lancet for firing, which is achieved by depressing the actuator button. Conveniently, the lancing device is configured for tactile recognition in the palm of a human hand and may preferably be operated one handed and without visual observation.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of the filing date of U.S. Provisional Patent Application No.  61 / 131 , 138  filed Jun.  6 ,  2008  and U.S. patent application Ser. No.  29 / 308 , 253  filed Jun.  5 ,  2008 , the disclosures of which are hereby incorporated herein by reference. 
     
    
     TECHNICAL FIELD 
       [0002]    This invention relates generally to devices utilized in the evaluation of glucose levels in patients with diabetes. More specifically, the present invention is directed toward improved lancing devices of the type utilized to pierce a patient&#39;s skin to produce a blood sample for glucose measurement. The lancing devices contemplated here are more ergonomic than prior devices (such as by being curved for orientation in the palm of a hand), which are predominantly pen-shaped, and therefore allow a previously unforeseen ease of use. This use extends to permitting one handed use through tactile manipulation, thus freeing the user&#39;s other hand and visual orientation for alternate endeavors. 
       BACKGROUND OF THE INVENTION 
       [0003]    It is well known that individuals with diabetes may monitor their blood glucose levels several times per day. This is typically accomplished by piercing the skin with a lancet, most commonly in the area of a finger or forearm, and then placing a blood droplet from the piercing on a test strip which is then placed in a blood glucose monitor to establish a reading. 
         [0004]    Most patients find it undesirable to pierce their own skin with a piercing device, so automatic lancing devices have become the norm. Heretofore, such devices have been cumbersome and not efficient. Predominantly, such devices have been pen-shaped, which can be cumbersome and not easily manipulated. 
         [0005]    Difficult manipulation is particularly problematic when the diabetic is a child, an elderly person, someone with a handicap, or one with limited dexterity. It would therefore be beneficial to provide a lancing device that has improved implementation characteristics. For example, a lancing device which is operable with one hand would be most beneficial. In the case of a diabetic child, the caretaker could use one hand to gently orient the child while the lancet was operated with the other. Additionally, the free hand could assist with the milking process if needed. Preferably, the initial operation could be conducted without visually observing the lancing device, thus leaving the caretaker&#39;s visual orientation available for overseeing the child. For the elderly, a less cumbersome and more user friendly device has obvious advantages, particularly if the person also has impaired visibility and/or dexterity. Even with fully able bodied persons, an ergonomically better and functionally easier device would be welcome. The lancing devices of the present invention provide such. 
       SUMMARY OF THE INVENTION 
       [0006]    In accordance with one aspect of the present invention, a lancing device may comprise a main body, the main body configured from a lower housing, an upper housing having an actuator button, the upper housing extending along a partial length of the lower housing, and an actuator operatively engaged to the upper and lower housings, the actuator extending along the remainder of the partial length of the lower housing. The lancing device may further comprise an endcap extending from the main body, where a lancet may be placed within the body such that movement of the actuator from a first position to a second position away from the endcap cocks the lancet for firing. 
         [0007]    In such a lancing device, the actuator may be returned to the first position while the lancet remains cocked for firing. 
         [0008]    In such a lancing device, the actuator button may be depressed to fire the cocked lancet. 
         [0009]    In such a lancing device, the lancing device may fit in the palm of a typical adult hand. 
         [0010]    In such a lancing device, the lancing device may be operated with one hand. 
         [0011]    In such a lancing device, the upper housing and the lower housing may remain stationary when the actuator is moved from the first position to the second position. 
         [0012]    In such a lancing device, the lower housing may be positioned against the forefinger of a typical adult hand while the actuator is moved with the thumb of a typical adult hand. 
         [0013]    In such a lancing device, the actuator may extend beyond the limits of the lower housing when in the second position. 
         [0014]    In such a lancing device, the actuator may further comprise a raised member to assist with movement thereof. 
         [0015]    In accordance with another aspect of the present invention, a lancet device having a main body, an actuator, and an actuator button may deploy by grasping the main body of the lancet device with a single hand, positioning the lancet device such that the actuator faces away from the user&#39;s body, placing the thumb of a user on the actuator while the main body rests in the palm of the user, and moving the actuator from a first position to a second position to cock the lancet, whereby the main body remains stationary. 
         [0016]    In such a method, the step of moving the actuator may be achieved with the user&#39;s thumb. 
         [0017]    Such a method may further comprise rotating the lancet device within the palm such that the thumb of the person is above the actuator button. 
         [0018]    Such a method may further comprise depressing the actuator button to fire the lancet. 
         [0019]    Such a method may further comprise placing a lancet within the main body of the lancet device. 
         [0020]    In such a method, the main body may comprise an upper portion and a lower portion, the lower portion sized and configured to mate directly with the upper portion and the actuator. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0021]    The present invention will be readily understood by one skilled in the art by reviewing the following detailed description in conjunction with the accompanying drawings, wherein like reference numerals designate like structural elements, and in which: 
           [0022]      FIG. 1  is a perspective view of a lancing device in accordance with a first embodiment of the present invention, where the lancing device includes an adjustable endcap; 
           [0023]      FIG. 2  is a frontal view of the lancing device of  FIG. 1 ; 
           [0024]      FIG. 3  is a rear view of the lancing device of  FIG. 1 ; 
           [0025]      FIG. 4  is a first side view of the lancing device of  FIG. 1 ; 
           [0026]      FIG. 5  is a second side view of the lancing device of  FIG. 1 ; 
           [0027]      FIG. 6  is a top view of the lancing device of  FIG. 1 ; 
           [0028]      FIG. 7  is a bottom view of the lancing device of  FIG. 1 ; 
           [0029]      FIG. 8  is a perspective view of a lancing device in accordance with a second embodiment of the present invention, the embodiment differing from the first embodiment by the replacement of a non-adjustable cap in lieu of the adjustable cap depicted in the first embodiment; 
           [0030]      FIG. 9 . is a frontal view of the lancing device of  FIG. 8 ; 
           [0031]      FIG. 10  is a rear view of the lancing device of  FIG. 8 ; 
           [0032]      FIG. 11  is a first side view of the lancing device of  FIG. 8 ; 
           [0033]      FIG. 12  is a second side view of-the lancing device of  FIG. 8 ; 
           [0034]      FIG. 13  is a top view of the lancing device of  FIG. 8 ; 
           [0035]      FIG. 14  is a bottom view of the lancing device of  FIG. 8 ; 
           [0036]      FIG. 15  is a perspective view of a lancet used with the lancing devices of the present invention; 
           [0037]      FIG. 16  is a top view of the lancet of  FIG. 15 ; 
           [0038]      FIG. 17  is a top perspective view of the pusher forming a portion of the lancing devices of the present invention; 
           [0039]      FIG. 18  is a bottom perspective view of the pusher of  FIG. 17 ; 
           [0040]      FIG. 19  is a frontal view of a first spring forming a portion of the lancing devices of the present invention; 
           [0041]      FIG. 20  is a side view of the first spring of  FIG. 19 ; 
           [0042]      FIG. 21  is a frontal view a second spring forming a portion of the lancing devices of the present invention; 
           [0043]      FIG. 22  is a side view of the second spring of  FIG. 21 ; 
           [0044]      FIG. 23  is an exploded perspective view of the lancing device of  FIG. 1 ; 
           [0045]      FIG. 24  is an internal view of a portion of the lancing device of  FIG. 1 ; 
           [0046]      FIG. 25  is a top perspective view of an actuator forming a portion of certain lancing devices of the present invention; 
           [0047]      FIG. 26  is a bottom perspective view the actuator of  FIG. 25 ; 
           [0048]      FIG. 27  is a perspective view of a first step in the use of the lancing devices of the present invention; 
           [0049]      FIG. 28  is a perspective view of a second step in the use of the lancing devices of the present invention; 
           [0050]      FIG. 29  is a perspective view of a third step in the use of the lancing devices of the present invention; and, 
           [0051]      FIG. 30  is a perspective view of a fourth step in the use of the lancing devices of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0052]    The following description of the exemplary embodiments of the invention along with accompanying figures is presented by way of illustration and to facilitate an understanding of the invention by one of ordinary skill. The description is neither intended to be exhaustive nor meant to limit the scope of the invention in any manner. Accordingly, many modifications and variations are possible in the light of the disclosure. 
         [0053]    Furthermore, the features and advantages described herein are not all-inclusive and, in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the drawings, specification, and claims. As will also be appreciated, the invention is capable of other and different embodiments, and its several details are capable of modifications in various respects without departing from the spirit and scope of the invention. 
         [0054]    As discussed previously, it is contemplated that the lancing devices of the present invention incorporate features which make the devices more ergonomic and better functioning than prior lancing devices, which are predominantly pen-shaped. For example, the lancing device of the present invention is contemplated as being curved for orientation and tactical recognition in the palm of a human hand, therefore allowing a previously unforeseen ease of use such as one handed use and blind use. The lancing devices may also be loaded with lancets and cocked for delivery of the lancet in a convenient and efficient manner. 
         [0055]    Referring to  FIG. 1 , a perspective view of a lancing device in accordance with a first embodiment of the present invention, it will be appreciated that the lancing device  100  may include a main body  102  configured from an upper portion  104 , a lower portion  106  mated to the upper portion, and an actuator  108 . The lancet device  100  may further include an endcap  110  mounted to the upper and lower portions  104 ,  106  by endcap shoulders  112 . 
         [0056]    The combination of upper portion  104  and actuator  108  are preferably configured to be of roughly the same length as the lower portion  106 . As will be appreciated when discussing use of the device, this enables the lower portion  106  to be retained in stationary relation with the palm of a user&#39;s hand while the actuator  108  is moved away from the endcap  110  and then toward the endcap. 
         [0057]    In the particular embodiment shown in  FIG. 1 , the endcap  110  is an adjustable endcap, whereby rotation of the endcap to the various positions indicated by the sized blood drops  114   a - c  (see  FIG. 6  for full views) positions the distal end of endcap closer or further away from the main body  102 . In the position rotated toward the smallest of the blood drops  114   c,  the endcap limits the excursion of a lancet placed within the lancing device such that the needle of the lancet penetrates the patient to a lesser degree than if the endcap were rotated toward the large blood drop, whereby the endcap would be positioned closest to the main body. 
         [0058]    The lancet device  100  may also include an actuator button  116  disposed within the upper portion, depression of which is utilized to fire the lancet once the mechanism is cocked. Cocking of the device  100  may be achieved by first loading a lancet within the device, retracting the actuator  108  by pulling or pushing the actuator away from the upper portion  104 , and then allowing the actuator to move back to the position shown in  FIG. 1  directly adjacent the upper portion. It will be appreciated that springs may be provided to resist or assist with such movements. 
         [0059]    Additional features of the lancet device  100  include a depression.  122  and associated tab  124  that are incorporated with the endcap  110 , and more specifically the endcap shoulders  112 . The depression  122  and tab  124  may be utilized to assist with removal of the endcap from the main body  102  of the lancet device by being suited for tactical and functional recognition by human fingers. 
         [0060]      FIGS. 2-7  depict additional views of the exemplary lancet device. Specifically,  FIG. 2  depicts a frontal view of the exemplary lancing device,  FIG. 3  depicts a rear view of the exemplary lancing device,  FIG. 4  depicts a first side view of the exemplary lancing device,  FIG. 5  depicts a second side view of the exemplary lancing device,  FIG. 6  depicts a top view of the exemplary lancing device, and  FIG. 7  depicts a bottom view of the exemplary lancing device. 
         [0061]    In each of the views shown in  FIGS. 2-7 , like elements have been numbered with the equivalent reference numerals. For example, in  FIG. 2  the front view depicts the endcap  110  in clear view. In this view, aperture  111 , from which the needle of the lancet may penetrate, is clearly view. It will be appreciated that it is this aperture  111  which moves closer to or away from the main body  102  when the endcap  110  is rotated to permit deeper or shallower penetration of the lancet needle. 
         [0062]    Moving briefly to a second embodiment of the lancing device, shown in  FIGS. 8-14 , it will be appreciated that the endcap  112 ′ may be fixed, such that excursion of the lancet from within the device is similarly fixed. In this regard, the level of penetration into a patient is fixed. Moreover, the endcap is preferably substantially clear or translucent such that a user can view the lancet piercing the skin and may further manipulate the main body after piercing to enlarge the penetration. When sufficient blood is witnessed through the clear window, the user may then remove the lancet from the skin. In other embodiments the endcap may be provided as an opaque endcap. 
         [0063]    The components previously listed, including the main body components and the two endcaps  112 ,  112 ′, are preferably constructed from plastic. It will be appreciated that any of the components, particularly the endcaps  112 ,  112 ′, may be configured from an antimicrobial plastic. Moreover, it is preferred that the upper and lower housings  104 ,  106  be one color while the actuator and actuator button  108 ,  116  are at least one other color to identify these moving components. 
         [0064]    Additional components of the lancing device  100  include a lancet  200 , shown in  FIGS. 15 and 16 . Lancets such as lancet  200  are generally known in the art, and consists of a holder  202  and a needle  204  held within the holder. As is known, the needle  204  is fixed relative to the holder  202  and includes a distal end  206  which extends beyond the limits of the holder  202 . It is this distal end  206  which is permitted to extend beyond the limits of the lancing device  100 , includes the point  208 , and penetrates the patient in use. 
         [0065]    Additional components include the pusher  300  shown in  FIGS. 17 and 18  and the first spring  400  and second spring  500 , the first spring being shown in  FIGS. 19 and 20  and the second spring being shown in  FIGS. 21 and 22 . 
         [0066]    The pusher  300  includes a holder  302  attached to a shaft  304  with a split head  306 . It will be appreciated that the holder  302  is adapted to accept a lancet, such as lancet  200 , within its cavity  308 . Moreover, the cavity is formed from a split  310  within the holder  302  such that the holder may expand to retain the lancet  200  in a frictional relation. Lastly, the portion of the holder  302  forming the split  310  may include a ramped portions  312  which provide progressive resistance against insertion of the lancet  200 , or, stated another way, provides progressive ease of release of the lancet upon withdrawal from the holder  302 . 
         [0067]    As stated above, the springs  400 ,  500  are shown in  FIGS. 19-22 . Typically, the springs are made from any of the various metals known in the art and commonly used. Such springs may have the same or different spring rates, typically with the first spring  400  being formed to a higher rate than the second spring  500 . 
         [0068]      FIG. 23  depicts an exploded view of the lancet device  100  of the first embodiment with the adjustable endcap. As such, shown is the upper-portion  104 , lower portion  106 , actuator  108 , endcap  110 , endcap shoulders  112 , button  116 , pusher  300 , and lastly springs  400 ,  500 . It will be appreciated that each of the elements include mating members, such as tabs, pins, and associated mating recesses for connection with the intended adjacent member. Such mating members are well known in the art. 
         [0069]    Operation of the lancing device  100  will be better understood upon evaluation of  FIG. 24 , a bottom view of the actuator  108  together with the holder  300  and springs  400 ,  500  installed. It will be appreciated that the springs  400 ,  500  are threaded onto the shaft  304  of the pusher  300  with the first spring nearest the holder  308  and the second spring nearest the split head  306 . In the meantime, the actuator  108  includes a partition wall  126  on its interior, the partition wall including an aperture (not shown). The pusher  300  and spring  400 ,  500  arrangement is arranged such that the split head  306  and second spring  500  are on one side of the partition wall  126  while the holder  308  and first spring  400  are on the other, the shaft  304  penetrating through the aperture of the partition wall. 
         [0070]    Additional views of the actuator  108  are shown in  FIGS. 25 and 26 . It will be appreciated that the actuator  108  also includes a slide member  128  extending beyond the portion of the actuator in view in  FIG. 1 . The slide penetrates into the combination of the upper housing  104  and lower housing  106  in retained relation, such that the actuator may be withdrawn from the combination of upper housing  104  and lower housing  106 . Such withdrawal compresses the first spring  500  and second spring  500 . Upon release of the actuator, the compression of the second spring  500  releases, but compression of the first spring  400  remains such that the lancing device  100  is cocked for firing. This cocking action is achieved by action of the holder  302  being retained by the button  116 . Upon depressing of the button  116 , the holder  302  is released and the needle portion of the lancet  200 , previously placed within the holder  302 , is forced through the aperture  111  of the endcap  110  to penetrate the skin of a patient. 
         [0071]    Moving to  FIGS. 27-30 , the method of using the lancing device  100  will be discussed in additional detail. 
         [0072]    It is assumed for purposes herein that the lancing device is preloaded with a lancet  200  as known in the art. 
         [0073]    The first step in such method is for the user to grasp the device  100  as shown in  FIG. 27 . Although shown with the user&#39;s thumb (T) over the actuation button  116 , such position is not necessary. Rather, the user may simply grasp the device  100  in the users palm (P). Of note is the curved ergonomic shape of the device  100 , including the side scallops  118  and lower ribs  120 , which aid in grasping and orienting of the device. 
         [0074]    From the standard position shown in  FIG. 27 , the user may rotate the device  100  within his palm (P) such that the actuator  108  faces away from the body, as shown in  FIG. 28 . From this position, the user may easily move the actuator  108  from the position shown in  FIG. 28  to the extended position shown in  FIG. 29 , away from the endcap  110 . To aid in such movement, the actuator  108  may include a raised portion  109 . This serves to cock the lancet  200  for delivery, as previously discussed. It will also be appreciated that such procedure may readily be accomplished with one hand. One feature of the device  100  in this regard is that the device is sized and configured such that the forefinger (FF) of the user may rest upon the lower housing  106 , as shown in  FIG. 28 . In this position, the lower housing  106  is stationary relative to the user&#39;s body and remainder of the main body  102  of the device as the actuator  106  is moved from the position of  FIG. 28  to the extended position of  FIG. 29 . 
         [0075]    Following such procedure, the device  100  may again be rotated back to the original position, as shown in  FIG. 30  whereupon a user may use his thumb (T) to depress the actuation button  116  to fire the lancet  200 . In this regard, it will be appreciated that the lancet  200  is fired from the distal end of the endcap  110 , through the aperture  111 , and into the skin of a patient, which may or may not be the user. 
         [0076]    After firing, the endcap  110  and shoulders  112  may be removed from the device  100  to expose the used lancet  200 , whereupon the lancet may be removed from the holder  302  and discarded. To aid in installation of a lancet  200  and subsequent removal thereof, the holder  302  may be constructed in a split configuration, as discussed above, such that the holder  302  may flex and retain the lancet in a frictional relation. In addition, the holder  302  may include ramped portions  312  to aid in insertion, retention, and removal of the lancet  200 , the lancet  200  using the ramped portions  312  to force open the holder  302 . 
         [0077]    Although, this invention has been described particularly in relation to the lancing devices disclosed, it will be recognized that the features and benefits of the overall construction described herein are applicable to other articles. Also, it would be realized by those skilled in the art that various modifications, alterations and adaptations can be made to this invention without departing from the spirit and scope of this invention. Numerous characteristics and advantages have been set forth in the foregoing description, together with details of structures and functions of the present invention. The foregoing description and disclosure, however, is illustrative only, and change may be made in arrangement and details, within the principle of the invention to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed. 
       INDUSTRIAL APPLICABILITY 
       [0078]    The present invention has applicability in the field of medical devices.