Abstract:
A device to register the dispensing of medicaments comprising sensing devices located at the medicament side to detect the dispensing thereof. The device is comprised of a sheet-like envelope of a one-way material and being a continuous, foldable way adapted to enclose the medicaments. There is an electronic printed circuit applied on the envelope and is stretched over foldable areas of the sheet-like envelope. It is also operatively connected to the sensing devices and to an electronic unit.

Description:
This application is the national phase of international application PCT/SE98/00256 filed Feb. 13, 1999 which designated the U.S. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to a medicament dispense sensing device comprising sensing devices located at the medicament dispense side to detect said dispense, the sensing devices being electrically connectable to an electronic sensing unit. 
     BACKGROUND OF THE INVENTION 
     The sensing devices are usually more or less integrated in such known devices (see e.g. U.S. Pat No. 4,616,316) or steadily connected to a package, e.g. a blister package, for the medicament or contain a separate sensingunit possibly being arranged in a container for the package (see e.g. U.S. Pat. No. 5,412,372). 
     SUMMARY OF THE INVENTION 
     An object of the present invention is to provide a one-way device of the kind mentioned above at low production costs and easily adaptable to different kinds of medicament packages without interfering with them. 
     According to one embodiment of the invention the device comprises a sheetlike envelope of a one-way material arranged in a continuous doublefolding way to enclose the medicaments and an on the envelope printed electrical circuit stretching over the sheetlike envelopes foldable portions and positively connected to said sensing devices and connectable to the electronic unit. 
     The device incorporating a foldable sheetlike envelope it can be produced quickly and easily at a low cost in form of semifinished products using sheet processing machines with subsequent stations for e.g. printing, foiling, punching, folding and embossing, and is by means of low tool and resetting costs adapted to medicament and blister packages of various shapes, quantities and geometries and with different graphical information. The semifinished products can thereafter be filled by means of an automized packaging automatics with medicaments and with the electronic unit and sealed to a finished package. The sheet material consists preferably of board, plastics or a combination of these. Within the medical service and the medicament handling, moreover, high hygienic standards are required. With an envelope of a one-way material the patient will always be supplied with a new and hygienic package. 
     The device is not influencing the integrity of today&#39;s clinically approved blister packages and therefore not either the enclosed medicaments. 
     Other features and advantages of the invention are evident from the claims and the detailed description to follow. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     An execution example of the invention is described herein below with reference to the enclosed drawing, on which 
     FIG. 1 shows a plane view of a spread sheetlike envelope for a device according to the invention, 
     FIGS. 2 and 3 show in perspective views several devices according to the invention and in a partly and a fully folded shape, respectively, 
     FIG. 4 shows in a larger scale a cut-off portion of a spread, sheetlike envelope according to FIG. 1 with a printed circuit, 
     FIG. 5 shows an underside of a dispense area of a device according to the invention, 
     FIG. 6 shows a cut-off portion of the sheetlike envelope with a printed circuit at a connection point for the electronic unit and 
     FIGS. 7A and 7B show in a cross section a portion of a device according to the invention supplied with a switch. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     In FIG. 1 a generally with  10  assignated sheetlike envelope is shown in a spread shape after a punching and folding operation. 
     In the execution example in FIG. I the envelope  10  is after the punching and folding operation devided into thirteen rectangular sheet fields a-m, being foldable along, folds or folding lines, shown with double lines such as  12  in FIG. 1 to enclose blister packages  30  in a folded shape after a packaging operation and an electronic unit  50  in form of a plane, parallelepipedic, compact package  38  (FIG. 2) like a diary or a planning calendar. 
     During the packaging operation first four blister packages, of which only one is shown, are placed in the sheet areas or flaps a-d with the blister packages  40  towards the areas e-h to surround the blister packages  40  so that each of the blister packages breakable dispense areas  42  for the medicaments corresponds to a matching breakable gate  16  in the areas e-h. Each breakable gate  16  is e.g. achieved by means of a partial punching of its profile. For keeping the flaps a-d together in the folded shape towards the corresponding sheet area e-h strings or ribbons  36  with adhering or glueing material are applied on the flaps a-d. The thus folded pairs of sheet areas ae, bf, eg and dh surrounding each its blister package  40  are thereafter folded in a zigzag pattern against each other (FIG. 2) along the corresponding vertical folds so that the blister packages  40  by means of the openings  14  exposed blisters are facing each other. The openings  14  and gates  16  corresponding to the blisters are vertically displaced with half a pitch between vertically adjacent sheet areas so that the blisters in one sheet area in a tightly packed way can be forced in between the blisters in the adjacent pair of sheet field during its folding. The thickness of two surrounded and folded blister packages thus corresponds essentially to the width of the ridges  18 ,  20  formed in the sheetlike envelope (FIG. 1) and are therefore not much larger than the thickness of a blister package  40 . 
     The remaining part of the sheetlike envelope  10  comprises in the illustrated example the sheet areas i-m and a pair or ridged  22 ,  24 . More precisely, the sheet areas i j k are adapted to surround a flat rectangular electronic unit  50 , connected to the onto the sheetlike envelope printed circuit to be described further on. The electronic unit  50 , arranged in the sheet area j in a way to be described later, is first folded together with the sheet area j towards the flap i. Then, flaps  21 ,  23  might be arranged in the sheet area j for by means of e.g. a here not shown string of a binder uniting the sheet area j and the sheet area i. For uniting the sheet areas in a safe way several, here not shown glue or binder strings corresponding to those shown in the sheet area a in FIG. 1 might be arranged. The binder may even consist of an outside laminate layer  90  (FIG. 6) on the sheetlike envelope  10 , possibly locally heated and coalesced, e.g. by means of ultrasonic welding of the folded sheet areas. This laminate layer  90  is also preferably even electrically isolating to mechanically and electrically protect said printed circuit. A similar laminate layer is conveniently even arranged between the sheetlike envelope  10  and the printed circuit. 
     The sheet areas a-f might in the folded shape as above be arranged on top of each other at the sheet areas i point in the following order (see FIG. 3) from the top downwards: j i h d c g f b a e. In case the electronic unit  50  has a display  52 , the sheet area k has a corresponding opening  32 , coinciding with the display  52  in the sheet area k when the packaging operation is terminated in folding the sheet areas  1  and m and the ridges  22 ,  24  on top of the previously described arrangement to form the package  38  shown in FIG. 2. A locking flap  30  on the sheet area m units the package  38  being inserted in a slot  38  with an opening  26 . Even the sheet area m has a display opening  34  so that the electronic units display  52  can be watched from the outside of the package  38  (FIG.  3 ). 
     A part of the above mentioned printed circuit is shown in FIG.  4 . The printed circuit stretches via connected printed circuit portions  54 ,  56 ,  58 ,  60 ,  62  in form of here not shown closed loops from the conducting connection with the electronic unit  50  to each of the sheetlike envelopes  10  gates  16  and back to the conduction connection with the electronic unit  50 . The printed circuit according to a preferred embodiment of the invention is provided by printing an electrically leading printing colour form of an electrically leading polymer material by means of conventional graphic printing methods, the colour especially conveniently been printed over the folds or folding lines  12  of a sheetlike envelope according to the present invention, as it due to its inherent toughness can resist a multiple folding without any risque for a wire break. The printed circuit portions  50  stretching over the folds  12  might, however, in accordance with FIG. 4, be printed with a broader width to almost exclusively avoid any risque for an unintended wire break. However, it is possible to provide the printed circuit in form of a printable electrically conducting, here not shown film. 
     The registration of a medicament dispensing is provided in that each conducting loop stretches over a removable gate  16  so that the gate  16  is torn off at least on one side, when e.g. a tablet is ejected from a corresponding blister, this being registered as known in the art in the electronic unit  50 , e.g. indicating the time and the position of the envelope/blister package. When the medicaments are used up according to the prescription the package is returned, the electronic unit  50  is thereafter removed and the registered data thereon are read for an eventual further evaluation of them. The electronic unit  50  can according to FIG. 3 even be provided with a diode lamp  53 , exposed to the environment by means of corresponding holes  33  in the sheet areas k and m. The diode lamp is intended to emit information bearing modulated light from the electronic unit  50  to a here not shown reading device. Thus, the electronic unit  50  must not be removed from the sheetlike envelope  10  to send information during a e.g. prevailing observation of a patient. The diode lamp  53  is adapted to be activated by means of a hidden switch  80  of a type to be described in detail later on. The electronic unit  50  might in a way known in the art even be provided with signalling devices to the environment, when e.g. the medicaments shall be dispensed from the device. 
     In FIG. 5 an example is shown more in detail of a configuration of the sheetlike envelope  10  at the portion of a dispense or exit area  42  for a tablet  44  of a blister package. Accordingly the breakable gates  16  periphery stretches outside of the blister packages  40  dispense area  42  for the tablet  44 . The only partly stamped-out and cut-out gate  16  is connected with the sheetlike envelopes  10  corresponding sheet area, e.g. a, by means of two opposite non-perforated kerfs or land areas  17 ,  17  and  19 ,  19 . In the unbroken shape these kerfs  17 ,  17  and  19 ,  18  achieve the electrical conductivity between the closed loops conductive portions  58 ,  60 ,  52 . When the tablet  44  is to be dispensed from the blister package  40  in that the user presses on the blister  41  (FIG. 2) exposed through an opening  14  in the opposite sheet area e, a pressure is applied on the gate  16  so that at least one pair of kerfs  17 ,  17  or  19 ,  19  bursts and thus the conductivity between the conductive portions  58 ,  60 ,  52  is interrupted and the tablet can emerge through the opening provided by the opened or fully eliminated gate  16 . The electric interruption is registered by the electronic unit  50  storing the place and time of the tablet dispense, basing on the information, which of the electric circuits closed loops has been interrupted. 
     A portion of the sheetlike envelope is shown with reference to FIG. 6 at a connecting point for the electronic unit  50 . The sheet area j in this execution example has an opening  70  with a profile with the exception of that a contact flap  25  essentially coincides with the electronic units  50  outside profile. The electronic unit  50  might in a preferred embodiment even be fixed by means of its here not shown resilient contact devices only on the contact flap  25  without the presence of the sheet area j and the flaps  21 ,  23 . In this case cavities are embossed in the sheet areas i and k, as indicated in FIG. 2 for the sheet area k, to receive the width of the electronic unit  50 . The flap  25  of the sheet area j forms a projecting male coupling device intended to be inserted into a corresponding slotlike female coupling device  51  in a longside edge of the electronic unit  50  so that the conducting ends of said closed loops and other conducting circuits might operatively be connected to the electronic unit  50  in such a way as it is illustrated in FIG.  6 . According to FIG. 6 the previously described isolating laminate layer  90  is not protruding over the contact flap  25  to enable an electrical contact between the conducting ends  74  and the electronic unit  50 . 
     In addition to the electrical interruption signals already described in connection with the dispense of a tablet  44  the electronic unit  50  might also register other signals, such as signals indicating the unbroken integrity of the package, the delivering of the package to a patient, resetting of a clock in the package for a new time zone, etc. 
     The conductor, such as the conductor  76  in FIG. 6, might therefore be a reference conductor for detecting any bursting of the envelope in some not expected way and also provide a calibration information for the electronic unit  50 . The conductor  76  stretches in the shown example like a frame around at least some portions of the boxshaped envelope  10 . Several such reference conductors might extend around the sheetlike envelope  10 . 
     A flap  78  is shown in FIG. 1, provided with e.g. a package identity number in form of a bar code to be torn away when delivering the package and thus starting a here not shown conductor break to register the dispense and its time in the electronic unit  50  by sending a start signal to it. As can be seen at  79  in FIG. 1 the identity number is printed on a further spot of the package for an identity control in connection with the consumed package is returned and the electronic unit  50  is removed from the sheetlike envelope  10  for e.g. a following systemic evaluation of the patients data. The package identity must thus not be registered in the electronic unit  50  which in this easier way might be reused in a new package. 
     Finally, in FIGS. 7A and 7B an example is shown of an in the envelope integrated switch  80 . The switch  80  is arranged in an area with three on top of each other placed sheet areas or flaps, e.g. somewhere in the three folded sheet areas i j k or by adding a here not shown sheet insert between a pair of sheet areas. The inserted sheet area j comprises an opening  82  permitting a manual depressing by means of a finger or a convenient device such as the blunt end of a pen of the upper sheet area k in contact with the lower sheet area i. The printed conducting portions  84  and  86  are thereby put into electrical contact with each other to close an electric circuit emitting a signal to the electronic unit  50 . If an electrically conductive glue  88  is applied on at least one of the sheet areas conducting portions  84 ,  86  the contact can permanently maintain the closing of said electrical circuit. This switch arrangement can be used to activate different functions or to readjust various parameters of the electronic unit  50 , e.g. the above mentioned activation of a diode lamp with information carrying modulated light or a stepwise change of a time zone setting of the electronic units clock.