Abstract:
The invention relates to an apparatus for self-treatment of diabetes. The apparatus is particularly advantageous by comprising a plurality of devices each of which has its own dedicated function corresponding to a number of acts which a diabetic must perform on himself. The individual devices are mutually interconnectible, and the combination comprises at least a body fluid analyser and a dosing apparatus for administering a predetermined dose of insulin to the patient. Each of the devices may be provided in several sizes so that the user himself may combine the relevant devices of the relevant size with respect to the current need. This reduces the risk of forgetting parts of the equipment, and the confidence of using the equipment is enhanced because it is evident to the user that it is a complete apparatus consisting of unified parts.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application is a continuation of U.S. application Ser. No. 09/870,392, filed May 30, 2001, which is a continuation of U.S. application Ser. No. 09/312,796, filed May 17, 1999, which applications are incorporated by reference herein. This application also claims priority under 35 U.S.C. § 119 of Danish application PA 1998 00714, filed May 20, 1998, and of U.S. Provisional Application No. 60/087,187, filed on May 29, 1998. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     This invention comprises a medical apparatus for use by a patient for medical self treatment of diabetes, the treatment including a first operation and at least a second operation, the apparatus comprising a first device for performing the first operation and a second device for performing the second operation.  
         [0003]     For a number of years it has been possible to purchase various devices for the treatment of diabetes, e.g. for injecting insulin, for measuring blood sugar (such a device is referred to as BGM below), for withdrawing blood samples, and other accessories, the purpose of which is to enable the patient to nurse his disease discretely and with a high standard of hygiene. Many diabetic patients are elderly people who can easily get insecure with respect to the medical equipment, but also many young people need to assure themselves that the equipment is in order, i.e. that everything is there. Or as one must often say to one&#39;s children: You have got it all, haven&#39;t you?  
         [0004]     It has also been attempted to build several of the necessary devices together to a single integral unit, see e.g. U.S. Pat. No. 5,536,249. This is not the ideal solution either, because such multi-functional devices are normally difficult to operate. A patient holding a gadget in his hand may not be entirely secure and convinced that he has set the apparatus to precisely the function to be performed by means of programmable computers. The more complicated an apparatus, the greater the risk of malfunction, meaning that two such multi-functional devices should actually be at disposal.  
         [0005]     The individual devices may be arranged for various respective functions relevant to the treatment of diabetes, such as: a lancet device, a body fluid analyser, a dosing apparatus for administering a predetermined dose of medication to the patient. Further, there is a number of other aids which the diabetic patient uses, e.g. test strips for the blood analyser, napkins for wiping off blood, extra insulin carpoule, glucose tablets, waste containers, etc.  
         [0006]     It is not common to build two individual devices together, as manufacturers within the field have tended to specialize in a single device. However, U.S. Pat. No. 4,469,110 discloses a lancet device and a simple form of BGM (the calorimetric measuring principle) which may be mutually interconnected to a single portable unit.  
       BRIEF SUMMARY OF THE INVENTION  
       [0007]     The object of the invention is to make the individual devices physically interconnectible with a view to optimizing self-treatment of diabetes.  
         [0008]     Another object is to construct the individual interconnectible devices such that the optimum treatment is as independent as possible of the specific situation of the user.  
         [0009]     A further object of the invention is to provide an apparatus of the present type for self-treatment of diseases, where, on one hand, the user is certain that he has all the devices which will be relevant for a future span of time, and on the other hand, is confident about the use of the apparatus.  
         [0010]     The object is achieved by making at least a BGM and an insulin doser interconnectible to a single device. Precisely this combination promotes the insulin treatment, as it will be more obvious to the user to adjust the insulin balance if he has just measured his blood sugar; or if the user knows that he is soon to take insulin, it will be more obvious to check the blood sugar content first. This combination departs from the common view where these two devices do not belong together, presumably because the manufacturers have specialized within either the one or the other device.  
         [0011]     The invention is not restricted to the combination of BGM and insulin doser devices, as these devices may be coupled with other devices which are used in the insulin treatment.  
         [0012]     The fact that the individual devices may be combined so that the apparatus covers precisely a given need, means that the apparatus takes up as little space is possible, it being simultaneously easy, even for visually handicapped users, to identify each individual device, so that they will be quite confident that the units fit together. When the devices fit together physically, the users will also be confident that the e.g. the measuring units used are the same. This improves the confidence of using the apparatus of the invention.  
         [0013]     A blood sugar measuring device normally comprises a temperature monitoring device, and in a preferred embodiment the latter device is arranged such that it is close to the insulin carpoule when the blood fluid analyser and the insulin injecting device are coupled together according to the invention. The temperature monitoring device may hereby be used not only for adjusting the blood sugar measurement, but may also be used to warn the user if the apparatus has been in a too hot environment and the insulin has been destroyed. This is a particular technical advantage by combining precisely the BGM and the doser.  
         [0014]     In addition to the possibility of coupling various devices together as needed, it is also possible for one or more of the devices to have several sizes. This may be relevant particularly for the insulin injecting device and for a storage device, enabling the user to combine precisely the devices of the relevant size which will be needed in a given situation, such as an evening party, a working day,. a weekend or on a holiday. The optimum treatment achieved by the apparatus of the invention is hereby more independent of the specific situations in which the user may be, and in which the treatment would be inconvenient with the known separate devices.  
         [0015]     In the invention, the devices have their own easily recognisable functions which are well-known to the user. The invention does not exclude the use of others of the user&#39;s older (i.e. well-known and secure) devices in combination with the invention, which, however, inspires the user to extend his self-treatment apparatus with units which fit together according to the invention.  
         [0016]     Conclusively, it is an essential feature of the invention that the stated advantages are of great importance to the user&#39;s perception of and habituation to regarding BGM measurement and insulin dosing as closely unified actions, which results in a better self-treatment. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]      FIG. 1  shows a prior art doser with a conventional cap.  
         [0018]      FIG. 2  shows a doser and a cap with a BGM attached.  
         [0019]      FIG. 3  shows a doser and a cap with a BGM and a lancet device attached.  
         [0020]      FIG. 4  shows a doser and a cap with a BGM, a lancet device and a container for test strips attached.  
         [0021]      FIG. 5  shows a cap with a BGM, a lancet device, a test strip container and an additional container together with useful/needed extras.  
         [0022]      FIG. 6  shows a cap with BGM, a lancet device, a test strip container and a mini-doser and a half-size container together with useful/needed extras.  
         [0023]      FIG. 7  shows a first combination of the items presented in  FIGS. 1-6 .  
         [0024]      FIG. 8  shows a second combination of the items presented in  FIGS. 1-6 .  
         [0025]      FIG. 9  shows a third combination of the items presented in  FIGS. 1-6 . 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0026]     In the following an embodiment of the invention will be described in detail with reference to  FIGS. 1-6 .  FIGS. 7-11  show some useful combinations which illustrate the use of the invention.  
         [0027]     The invention also opens up the possibility of a wide variety of combinations as each of said devices may be provided in several sizes. The preferred insulin dosing device may e.g. be replaced by two insulin injection pens of half the size, and a waste container may be inserted instead of one of these pens.  
         [0028]      FIG. 1  shows a doser  20  and a cap  10 . The doser  20  comprises a turning wheel  21  for adjusting, either electronically or manually, the level/amount of medication to be administered, and a display  22  that shows the currently selected amount of medication to be administered. The doser  20  has processing means and storage facilities, like a CPU and RAM, for storing data, like the time, date and amount of medication of the last couple of administrations. This information can be shown in the display  22  at request. The doser  20  further comprises a carpoule (not shown) that contains the medication, and is fitted with a needle  27  through which the medication is administered. The doser  20  has a transparent window  25  so that the amount of medication left in the carpoule can readily be identified. The cap  10  can be fitted to the doser  20  so that one single compact unit and protection of the doser  20 , needle  27 , etc. is obtained.  
         [0029]      FIG. 2  shows a doser  20  which corresponds to the doser in  FIG. 1 . Also shown is a cap part  10 , and a BGM  30 . The invention is based on the circumstance that the doser  20  and the BGM  30  should be used together very frequently, one embodiment of the invention might be a cap where the BGM  30  is an integral part. Another embodiment, which is the one shown in  FIG. 2  and described later, could be one where the BGM  30  can be fitted removable by the locking means  31  to the cap part  10  in such a way that a single unit  35  serving as a cap is formed. This has the advantage that when the cap unit  35  is fitted to the doser  20 , one set of parts associated functionally can be obtained in a very compact and convenient form. Another option available to the user by this arrangement is that if in special cases the BGM  30  is not needed in a given situation, the user can simply leave the BGM  30  at home, thereby reducing and keeping the size of the device to an absolute minimum.  
         [0030]     The BGM  30  has means  34  for inserting test strips  52  (not shown, see  FIG. 4 ) containing a sample of blood, for analysis by the BGM  30  by operating the buttons  36 . The result of the analysis is shown in the display  32 .  
         [0031]     The cap unit  35  may also be provided with a temperature sensor  12 , which determines the outside temperature during operation of the BGM  30 . This temperature is needed for the calibration of the BGM  30  prior to the analysis of a blood sample. The temperature. sensor  12  could be placed close to the carpoule, so that an additional benefit, apart from being used in the calibration, is achieved when the cap unit  35  is fitted over the doser  20 . In this location the sensor  12  can monitor the temperature of the medication contained inside the carpoule. This additional feature is very convenient if the medication is sensitive to temperature and could be ruined or damaged if the temperature of the medication is outside a given interval. Thus the BGM  30  could notify the user if the medication has been exposed to a harmful temperature, which improves the user&#39;s safety, especially in the case of the medication being insulin, where the consumption/injection of damaged medicine could cause life-threatening situations.  
         [0032]      FIG. 3  shows a doser  20  and a cap unit  35 , preferably comprising the cap  10  and the BGM  30 , like the cap unit in  FIG. 2 , but with the additional feature of having a lancet device  40  removably attached to the BGM  30  by the locking means  31 . This lancet device  40  is used by first loading the lancet device through the grip  44  and then pressing the button  42 , which releases the lancet, piercing the skin, so that a blood sample can be obtained. With this inclusion the lancet device  40  is always at hand. This has the advantage that a lancet device  40  always is available, for taking a blood sample and applying it to a test strip  52 . The test-strip  52  can then be inserted via the means  34  into the BGM  30 , which will start analysing the blood sample and, after completion of the analysis, will show the result in the display  32 . It is very useful to have the BGM  30  and the lancet device  40  attached together in one compact unit, since a BGM  30  would not normally be used without the lancet device  40 , thereby avoiding the fuss and uncertainty of using multiple devices of perhaps different makes. On the other hand, if the user already has a lancet device and is accustomed to and familiar with the use of this particular lancet device, he can still use this original lancet device and just use the remaining items, which will be a compact set consisting of a doser  20  and a BGM  30 ; The cost will be reduced hereby.  
         [0033]      FIG. 4  shows a doser  20  and a cap unit  35  from  FIG. 3 , but where the additional feature of a test strip container  50  for the safe keeping/storing of test-strips  52  in the space  55  can be added/attached through locking means  31 . With this addition a test strip  52  will always be available. This addition further strengthens the use of the compact unit obtained, when the cap unit  35  is fitted to the doser  20 . Now the user can either have a single compact unit where all the means for taking and analysing a blood sample are available, or have an even smaller compact unit with just the items (e.g. doser  20  with a BGM  30  plus either a test strip container  50  or a lancet) that are needed, depending on the specific situation.  
         [0034]      FIG. 4  shows one of the many possible combinations which may be achieved with the apparatus according to the invention. Other examples of expedient combinations are shown in  FIGS. 7-9 . The combination shown in  FIG. 4  has the general advantage that it may induce the user to make some additional blood sugar measurements and possibly regulate with insulin injection when the parts are in an assembled state as one unit. There are also situations in which many blood sugar measurements and injections are required, viz. in connection with so-called insulin analogs which are very rapid action substances, within the order of 10 minutes.  
         [0035]      FIG. 5  shows a cap unit  35  that corresponds to the cap unit in  FIG. 4 . Instead of having a doser  20 , there is now provided a container unit  60  with a relative large space  69  for storing the items needed everyday for self-treatment. For a diabetic, e.g. such items could be a napkin  61  for wiping excessive blood after a sample has been taken, a waste container  62  for receiving used items, an extra carpoule  63  which could contain another type of insulin, spare needles  27  for the doser, spare lancets  65  for the lancet device  40 , some glucose in the form of glucose tablets  64 , etc. In some situations and in certain forms of diabetes, the injection of insulin may be replaced by administration of pills which may be stored in the container, which thus replaces the doser described previously. All these items, or the most relevant ones for a given situation, could be held in the container space  69  for easy retrieval, when needed. Previously the user had to carry a bag for each device (BGM, doser, lancet device, etc.) with the respective accessories. So when the cap unit  35  is fitted to the container unit  60 , a single compact, easily portable unit is obtained, which can be customised to meet an individual need for an individual day or situation.  
         [0036]     Of course, the individual devices may also be interconnected without the BMG and the doser being coupled together according to the invention. If the doser  20  is not needed—a diabetic does not always need a doser in all situations, since sometimes he only need to observe the glucose level in his blood and regulate this level through a diet—one compact unit with all necessary items readily available is obtained. If a doser  20  is needed, the doser  20  may be fitted with an ordinary cap  10 , and thus there will just be two units that contain everything needed in every situation in a very compact and convenient form.  
         [0037]      FIG. 6  shows a cap unit  35  and extras  61 - 65  and  27  corresponding to the unit and extras in  FIG. 5 . Also shown is a simple small-sized (e.g. disposable) doser  80  (e.g. an insulin injecting pen) with a turning wheel  85  for adjusting the level/amount of medication to be administered. During the adjustment, a display  84  shows the currently selected amount of medication to be administered. After the appropriate level of medication has been set, the user can press the release button  82 , which manually injects/administers the selected amount of medication through the needle  87 . The doser  80  further comprises a carpoule (not shown) that contains the medication. The doser  80  has a transparent window  88 , so that the amount of medication left in the carpoule readily can be identified. This embodiment also includes a container unit  70 , which is half the size of the container unit  60  in  FIG. 5 . These small size units  70 ,  80  can be fitted into the cap unit  35  so thereby forming one compact self-treatment unit.  
         [0038]     So with this set of modules an optimal compact set can be customised with the things needed for a given situation. The set can either be configured to meet a situation where all the items are needed, thus ending up with two compact units, namely the doser  20  with an ordinary cap  10  and a cap unit  35  with the large container  60  that contains some or all of the extras  61 - 65  and  27 , or be configured to a minimal set containing just items needed for one single situation, e.g. the small doser  80 , the half-size container  70  fitted into the cap unit  35  with/without the BGM  30 , the lancet device  40  and the test strip container  50 , depending on the specific situation.  
         [0039]      FIG. 7  shows a combination of the cap  10 , the BMG  30  and the storage container  60 . Such a combination of devices is relevant e.g. in connection with type 2 diabetics who may take insulin regulating medication in tablet form. Here, the storage container  60  may contain spare lancets  65  (which may belong to another make of lancet devices, which are not shown in the combination in  FIG. 7 ), test strips  52 , glucose in the form of glucose tablets  64  and the insulin regulating medication in tablet form. Another use of the combination shown in  FIG. 7  is non-refrigerated storage of extra insulin, the temperature then being monitored by the temperature monitoring device  12 .  
         [0040]     The combination shown in  FIG. 8  might be called all in one. The insulin injecting device is replaced by an insulin injecting pen of half the size, which gives room for a container  70  (half as large as the container  60  in  FIG. 7 ).  
         [0041]      FIG. 9  shows another possible combination, using two insulin injecting pens so that the user may carry rapid action insulin as well as slow action insulin. One of the pens may also contain one of the very rapid action insulin analogs mentioned above. Clearly, the combination in  FIG. 9  may also be supplemented with a lancet device as shown in  FIG. 8 .  
         [0042]     It will now be appreciated that there are many possible combinations which allow the user to combine precisely the equipment he needs in a given situation. In the preferred embodiments, the individual devices are combined side by side, and the storage container and the insulin injecting device are shown in the lateral direction in larger or smaller embodiments. Clearly, an apparatus according to the invention may also comprise devices which may be interconnected and varied in the longitudinal direction.