Abstract:
A disposable, wearable, self-contained insulin dispensing device includes a housing and an insulin source in the housing that is connected to a catheter for injecting insulin into a user. The catheter projects generally perpendicularly to a generally planar surface of the housing configured for abutting a skin surface of the user; which planar surface includes an adhesive layer for adhering the housing surface to the skin surface. A removable release sheet covers the adhesive layer for protecting the adhesive layer prior to use of the device. The release sheet is provided with a catheter protection element to enclose and protect an end portion of the catheter, such that removal of the release sheet for exposing the adhesive layer also exposes the end portion. A pump in the housing includes an actuator employing a shape memory alloy wire.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a Continuation of co-pending International Application No. PCT/DK2003/000916, filed Dec. 19, 2003, and it is also a Continuation-in-Part of co-pending U.S. application Ser. No. 11/121,708, filed May 4, 2005, which is a Continuation of International Application No. PCT/DK2003/000753, filed Nov. 4, 2003. The disclosures of all of the aforesaid related applications are incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to wearable medicine dispensing devices, particularly insulin dispensing devices. 
     In connection with injection of insulin for treating Type I and Type II Diabetes extremely important features are simplicity of operation, reliability, cost and flexibility, which all are related to the issue of compliance which particularly in the cases of relatively mild Type II diabetes is a problem with important consequences regarding the success rate in treating the patients. 
     SUMMARY OF THE INVENTION 
     The main object of the invention is to provide a wearable medicine, particularly insulin dispensing device having features and operation characteristics supporting and easing compliance by the users of the device. 
     The present invention provides a disposable, wearable, self-contained medicine, particularly insulin dispensing device comprising
         a housing,   an insulin source in said housing,   a pump means in said housing and adapted for pumping insulin from said insulin source to a catheter for injection of said insulin in a user of the device and, said catheter being associated with said housing and projecting generally perpendicularly to a generally planar surface of said housing intended for abutting a skin surface of a user of the device,   an adhesive layer provided on said planar surface for adhering said planar surface to said skin surface, and   a removable release sheet covering said adhesive layer for protecting said adhesive layer prior to use of said dispensing device, said release sheet being provided with catheter protection means to enclose and protect an end portion of said catheter such that removal of said release sheet for exposing said adhesive layer exposes said end portion.       

     Hereby, in a simple, reliable and cost-effective manner a device is provided which is easy to apply and still in an effective manner protects the catheter against damage and contamination until use of the device is initiated. 
     In another aspect, the invention provides a disposable, wearable, self-contained medicine, particularly insulin dispensing device comprising
         a housing,   an insulin source in said housing,   a pump means in said housing and adapted for pumping insulin from said insulin source to a catheter for injection of said insulin in a user of the device and, said catheter being associated with said housing and projecting generally perpendicularly to a generally planar surface of said housing intended for abutting a skin surface of a user of the device,   an adhesive layer provided on said planar surface for adhering said planar surface to said skin surface,   a combined microphone and loudspeaker associated with said housing, preferably arranged inside said housing, and   recording and play back means connected to said combined microphone and loudspeaker and associated with said housing, preferably arranged inside said housing, such that verbal messages may be recorded and played back by said dispensing device.       

     Hereby a device promoting simple communication between a health care provider and the user is provided with readily understandable operation and with good effect on the compliance rate. 
     In yet another aspect, the invention provides a disposable, wearable, self-contained medicine, particularly insulin dispensing device comprising
         a housing,   an insulin source in said housing,   a pump means in said housing and adapted for pumping insulin from said insulin source to a catheter for injection of said insulin in a user of the device, and   an actuator for said pump means, said actuator comprising a shape memory alloy wire, said actuator preferably further comprising a ratchet gear or pawl wheel, a pawl adapted for co-operating with said pawl wheel and connected to one end of said shape memory alloy wire and a spring means connected to said pawl, the connections between said pawl and said wire and said pawl and said spring means being such that contraction of said wire rotates said pawl wheel against the spring force of said spring means.       

     Hereby a pump means requiring very low energy and with a high degree of reliability is provided at a relatively low cost. 
     In a yet further aspect, the invention relates to a disposable, wearable, self-contained insulin dispensing device comprising
         a housing,   an insulin source in said housing,   a pump means in said housing and adapted for pumping insulin from said insulin source to a catheter for injection of said insulin in a user of the device,   an actuator for said pump means, preferably an actuator comprising a shape memory alloy wire, and   controlling means for controlling the operation of said actuator according to a program, said program consisting in a sequence of a certain amount of actuations of said actuator per 24 hour time periods, or, in connection with provision of a timing means connected to said controlling means said program consisting in a sequence of actuations of said actuator that varies according to the time of day or, in connection with provision of a timing means connected to said controlling means and an input device for inputting data to said controlling means, adapting said controlling means so as to be programmable by means of said data, or adapting said program of said controlling means to comprise algorithms for automatically altering the sequence of actuations of said actuator according to input of data relative to the actual glucose level in the blood of the user of the device and/or intake of nutrients by said user.       

     Hereby, compliance is enhanced by providing a device with capabilities of rendering a very specific and well-tuned dosage which may be altered according to the specific development of the individual user. 
     So as to achieve a compact dispensing device, the pump means may comprise a piston rod for displacing a piston in a cylindrical container of said medicine to be dispensed and an actuator for displacing said piston rod, wherein said piston rod is configured such that the portion of said piston rod between said actuator and said piston is rectilinear and rest of said piston rod is arcuate, and such piston rod may comprise elements arranged in a row and interconnected by hinge elements, wherein each element is provided with a surface spaced from said hinge element and configured to abut a corresponding surface of an adjacent element when said piston rod is rectilinear, and said elements may be provided with screw threads on the outer surface thereof for co-operating with corresponding screw threads of the actuator. 
     In an alternative embodiment such piston rod may comprise a strip having an arcuate cross section taken transverse to the longitudinal direction of said strip which is rectilinear between said actuator and said piston while the rest of the strip is wound into a roll. The strip may be provided with apertures, preferably transversely extending slits, evenly spaced along the length thereof for receiving corresponding projections of said actuator. 
     In a yet further aspect, the invention provides a combination of a dispensing device as specified above and a programming controller, said dispensing device and said programming controller comprising co-operating transmission and/or receiving means for mutual communication of data, said programming controller preferably being a cellular telephone or a personal computer or a laptop computer or a hand held computer. 
     Moreover, the invention provides a method of controlling the operation of a disposable, wearable, self-contained insulin dispensing device comprising
         a housing,   an insulin source in said housing,   a pump means in said housing and adapted for pumping insulin from said insulin source to a catheter for injection of said insulin in a user of the device,   an actuator for said pump means, preferably an actuator comprising a shape memory alloy wire, and   controlling means for controlling the operation of said actuator according to a program,
 
said method comprising the steps of:
   providing said controlling means with data for generating and/or amending said program prior to and/or after initiation of use of said dispensing device.       

     Furthermore, in a yet other aspect, the invention also relates to a method of controlling the operation of a disposable, wearable, self-contained medicine, particularly insulin dispensing device comprising
         a housing,   an insulin source in said housing,   a pump means in said housing and adapted for pumping insulin from said insulin source to a catheter for injection of said insulin in a user of the device and, said catheter being associated with said housing and projecting generally perpendicularly to a generally planar surface of said housing intended for abutting a skin surface of a user of the device,   an adhesive layer provided on said planar surface for adhering said planar surface to said skin surface,   a combined microphone and loudspeaker associated with said housing, preferably arranged inside said housing,   recording and play back means connected to said combined microphone and loudspeaker and associated with said housing, preferably arranged inside said housing, such that verbal messages may be recorded and played back by said dispensing device, and   manual operating means for manually controlling the operation of said dispensing device said method comprising the steps of:   recording verbal instructions in said recording means for instructing the user of the device in the operation of said dispensing device, and   playing back said verbal instructions.       

     Finally, the invention relates to a method of controlling the operation of a disposable, wearable, self-contained medicine, particularly insulin dispensing device comprising
         a housing,   an insulin source in said housing,   a pump means in said housing and adapted for pumping insulin from said insulin source to a catheter for injection of said insulin in a user of the device and, said catheter being associated with said housing and projecting generally perpendicularly to a generally planar surface of said housing intended for abutting a skin surface of a user of the device,   an adhesive layer provided on said planar surface for adhering said planar surface to said skin surface,   a combined microphone and loudspeaker associated with said housing, preferably arranged inside said housing,   a programmable computing means associated with said housing, preferably arranged inside said housing, and   signal conversion means connected to said combined microphone and loudspeaker and associated with said housing, preferably arranged inside said housing, and adapted for converting received audio signals into input signals for said computing means and for converting output signals from said computing means to audio signals,
 
said method comprising one or more of the steps of:
   transmitting audio signals to said microphone for controlling the operation of said dispensing device,   receiving audio signals from said loudspeaker for evaluating the operation of said dispensing device.       

    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In the following, the invention will be described and explained more in detail in connection with various embodiments of an insulin dispensing device according to the invention shown, solely by way of example, in the accompanying drawings where: 
         FIG. 1  is a schematic isometric view of a first embodiment of a disposable insulin dispensing device according to the invention before the adhesive pad for adhering the device to the skin of a user has been mounted on the device, 
         FIG. 2  is a schematic isometric view of the device of  FIG. 1  seen from another angle and with the adhesive pad mounted thereon, 
         FIG. 3  is a schematic isometric partly exploded view of the device of  FIG. 2 , 
         FIG. 4  is a schematic entirely exploded view of the device of  FIG. 2 , 
         FIG. 5  is a schematic isometric view of the device of  FIG. 2  together with a programming device according to the invention, 
         FIG. 6  is a schematic enlarged scale exploded view of a shape memory alloy actuator mechanism according to the invention of the device of  FIG. 2 , 
         FIG. 7  is a schematic view corresponding to  FIG. 6  with the elements of the shape memory actuator shown in interconnected operative relative positions, 
         FIG. 8  is a schematic isometric view of a second, more compact embodiment of a disposable insulin dispensing device according to the invention, 
         FIG. 9  is a schematic, isometric view of the device of  FIG. 8  with the top removed so as to illustrate the co-operating elements of the device, 
         FIG. 10  is a schematic, isometric view of the device of  FIG. 8  seen from another angle than  FIG. 9 , 
         FIG. 11  is a schematic exploded view of the device of  FIGS. 8-10 , 
         FIGS. 12   a - 12   c  are very schematic views, seen in the direction of the axis of the carpule, of the operation of the drive mechanism of the device of  FIGS. 8-11  illustrating the interaction of the pawl or ratchet wheel with the spring elements and the shape memory alloy wire, 
         FIGS. 13-15  are schematic views illustrating a first embodiment of an actuator with a flexible piston rod according to the invention for use in a compact dispensing device according to the invention, 
         FIG. 16  is a schematic isometric view illustrating a second embodiment of an actuator with a flexible piston rod according to the invention for use in a compact dispensing device according to the invention, and 
         FIGS. 17-19  are graphs illustrating different insulin dispensing programs. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Generally speaking, although the device according to the invention is primarily intended for dispensing insulin, it may also be used for dispensing other medicinal substances such as pain-killers, anti-biotics and so on, such that whenever the term insulin is used herein, any other dispensable medicine is intended to be covered by the term insulin unless not applicable either by explicit indication or by implicit indication owing to the context wherein the term insulin is employed. Furthermore, it should be noted that when the term carpule is utilized, it is not in any way limited by the WIPO resolutions or any trademark interpretation but is used to denote any cartridge, container, ampoule etc. suitable for storing and dispensing medicinal compounds. 
     Referring now to  FIG. 1 , a disposable insulin dispensing device according to the invention, generally referenced by the numeral  1 , comprises a water-tight generally cylindrical housing  2  provided with a push button  3  for activating and deactivating the device as well as for activating a so-called bolus operation as explained in the following. 
     The housing further comprises a transparent window  4  for inspecting the operation of the device and apertures  5  for transmission of sound waves as explained in the following. 
     At one end of the housing  2  there is provided a stiletto  6  having a sharp needle  7  extending through a catheter  8  connected to a not shown insulin container or carpule inside the housing  2  as explained in the following. 
     Referring now to  FIGS. 2-3 , the housing  2  is fixedly received in a trough  9  of an adhesive pad  10  made of a combination of a plate  11  of skin-friendly adhesive material, for instance as well known in the field of ostomy pouches, see for instance European patent application no. 0413250 and European patent application no. 0092999, and a relatively compressible portion  10   a  made of foam material attached to the plate  11 . The catheter  8  extends through the planar portion  11  of the pad  10 . The push button  3  is protected by the foam material  10   a  so as to avoid inadvertent operation of the button for instance when the user is asleep. 
     A slip release film  12  is adhered to the bottom surface of the adhesive plate  11  for protecting the adhesive surface of the plate  11  such that the adhesive properties are intact when the pad is to be adhered to the skin of a user of the dispensing device. The release film  12  is provided with a protective hollow projection  13  for receiving the catheter  8  and the needle  7  of the stiletto  6  so that the needle  7  and the catheter  8  are protected by the projection  13  before use of the dispensing device  1 . The housing  2  is provided with an end cover  14  on which the catheter  8  is mounted by means of a communication bushing  15  provided with an internal elastomeric mass (not shown) and a communication passage for communicating the catheter  8  with the interior of the housing  2  as explained in the following in connection with  FIG. 4 . 
     In use, the user removes the protective release sheet  12  thereby exposing the tip of the needle  7  such that the needle may be inserted subcutaneously at the same time that the adhesive pad  10   a ,  11  is adhered to the abdominal skin of the user. When the needle  7  and the catheter  8  have been inserted subcutaneously and the device has been adhered to the skin of the user, the stiletto  6  is removed whereby communication is established between the catheter  8  and the interior of the housing  2  for supplying insulin subcutaneously to the user of the device. 
     The elastomer mass in the bushing  15  seals the exit opening of the needle  7  when it is removed such that no insulin may leak through said exit opening but is constrained to flow solely from the carpsule to the catheter  8 . 
     Referring now to  FIG. 4  showing an exploded view of the components of the insulin dispensing device according to the invention, the housing  2  contains a container or a carpule  16  for storing and dispensing insulin. The container or carpule  16  is of a well-known type having a perforatable dispensing projection  17  for receiving a catheter  18  for communicating the interior of the container  16  with the catheter  8  through the communication bushing  15  when the needle  7  has been retracted from said elastomeric mass inside the bushing  15  as explained above. 
     A spindle  19  provided with a piston  20  is received in the container  16  such that axial displacement of the spindle towards the dispensing projection  17  will press insulin through the catheter  18  to the catheter  8 . The spindle  19  is rotated and displaced by means of a shape memory alloy actuator described more in detail in the following with reference to  FIG. 6 . 
     A battery  21  for supplying power to the shape memory actuator is provided adjacent an end cover  22  of the housing  2 . 
     The shape memory actuator comprises a pawl or ratchet wheel  23 , a guide bushing  24 , a spring wheel  25  and a shape memory wire  26 . The operation of the shape memory actuator will be described more in detail in the following with reference to  FIGS. 6 and 7 . 
     A printed circuit board  27  is provided for controlling the function of the dispensing device and the various operational steps thereof as described in the following. 
     Finally a combined microphone/loudspeaker  28  is arranged inside the housing  2  adjacent the apertures  5  for receiving and emitting sound waves for the purposes described below. 
     Referring now to  FIG. 5 , a programming device or controller  29  having programming keys  30  and a display  31  is shown proximate the dispensing device for communicating with a not shown receiver/transmitter arranged inside the housing  2 . The communication may take place by infra red signals or other suitable signals transmitted from and to an opening  32  leading to a transmitter/receiver inside the controller  29  to and from, respectively an opening  33  (see  FIG. 2 ) in the end cover  22  of the housing  2  leading to said not shown transmitter/receiver inside the housing  2 . 
     Referring now to  FIGS. 6 and 7 , the spindle  19  is displaced axially in the direction of the arrow R 1  by counter-clockwise rotation of the pawl wheel  23  in the direction of the arrow R 2  whereby the thread  36  meshing with the internal thread  37  results in said axial displacement whereby the piston  20  is displaced further into the carpule  16  to dispense insulin through the catheter  18  to the catheter  8  ( FIG. 4 ). 
     Rotation of the pawl wheel  23  is accomplished by means of the shape memory alloy (for instance Nitinol) wire  26  attached to electrically conductive rods  38  and  39  that are fixed in recesses  40  and  41 , respectively, in the electrically non-conductive guide bushing  24  and the electrically conductive spring wheel  25 , respectively. 
     The recess  40  is provided with not shown electrical contacts for electrically connecting the rod  39  to the battery  21  for supplying electrical current to the shape memory alloy (SMA) wire  26  to heat it in a manner and sequence controlled by the programme program elements in the printed circuit board  27 . 
     The spring wheel  25  has U-shaped spring arms  44  and  45  for exerting a spring force on the ends  46  and  47  thereof, respectively, in a direction towards the center of the pawl wheel  23  such that the ends  46  and  47  are constantly biased to enter into engagement with the teeth of the pawl wheel  23 . 
     The stop pins  42  and  43  are electrically connected to the print printed circuit board  27  for emitting an electrical signal thereto when the spring wheel arm  48  contacts said stop pins. 
     The rod  38  is as mentioned above electrically connected to the power source such that an electrical current may be passed through the rod  38 , the wire  26 , the rod  39 , the loop recess  41  and the spring wheel  25  to heat the wire  26  to cause the wire to contract and rotate the pawl wheel the distance of one tooth in the direction of arrow R 2  by means of the arm end  46  engaging a tooth of the wheel until the arm  48  contacts the stop pin  42  that emits a signal to the control printed circuit board  27  whereby the current through the wire  26  is interrupted and the SMA wire  26  cools off and expands. 
     The other arm end  47  engages a tooth of the wheel  23  as a pawl and prevents the wheel  23  from rotating clock-wise. The spring effect of the spring wheel  25  in the tangential direction causes the arm  42  to move back into contact with the stop pin  43  thereby tightening the expanded SMA wire  26 . 
     The signals from the stop pins  42  and  43  are also utilized to indicate correct functioning of the pump and as an indication of the number of doses administered through the catheter  8 . 
     Referring now to  FIGS. 8-12 , a second, more compact, embodiment of a medicine pump  51  according to the invention comprises a housing upper portion  52  and a housing lower portion  53 , the upper portion  52  having audio apertures  54  for allowing audio signals to travel relatively unencumbered through the wall of the upper portion  52  from and to an audio element  54   a , a bolus button aperture  55  for allowing depression of a bolus button  56  and an inspection aperture  57  covered by a transparent element  57   a  for allowing monitoring of the contents of an insulin carpule  58  provided inside the housing. 
     The lower housing portion  53  is adhered to an adhesive pad  59  covered by a release sheet with a needle protection projection or indentation  61  very similar to the corresponding elements of the embodiment of  FIGS. 1-4 . The carpule  58  co-operates with a catheter/stiletto assembly  62  in the same manner as described in connection with the embodiment of  FIGS. 1-4 . 
     The embodiment of  FIGS. 8-12  is very similar in construction and in operation to the embodiment of  FIGS. 1-4  with the exception of the rigid rectilinear spindle or piston rod  19  being substituted by a flexible piston rod  63  according to the invention and the design of the shape memory alloy wire actuator as will be described in the following. 
     A piston  64  corresponding to piston  20  of  FIG. 4  is attached to one end of a flexible piston rod  63  constituted by a series of elements  65  interconnected by hinge means  66  (see  FIGS. 13-15 ) and arranged for movement between two guide walls  63   a  and  63   b . The piston  64  abuts a displaceable wall or piston  66  of the carpule  58  such that axial displacement of the piston  64  will press insulin out of the carpule  58  into the catheter assembly  62 . 
     The elements  65  are integral with each other by means of hinges  66  which allow adjacent elements to pivot relative to one another from the position abutting one another shown in  FIG. 14   a  wherein the elements  65  together form a rectilinear piston rod with abutment surfaces  65   a  and hinges  66  affording rigidity and thus rendering the piston rod  63  capable of exerting a pressure on the piston  66  of the carpule without laterally deflecting, to the position shown in  FIG. 14   b  wherein the elements are pivoted way from one another so as to allow the curvature of the piston rod  63  which allows the compact configuration of the device with the initially major part of the piston rod extending along the length of the carpule  68 . 
     The material of the flexible piston rod  63  is any suitable moldable material, but it is preferred that the material is a plastics material such as Nylon or POM because of cost and re-cycling issues. 
     Each element  65  is provided with exterior threads  67  on two opposed portions  69  and  70  of the elements having a circular cylindrical configuration for allowing an internal thread  71  of a pawl or ratchet wheel  72  ( FIG. 12 ) to mesh therewith such that rotation of the pawl wheel  72  will displace the piston rod  63  into the carpule  58 . At least the side of the elements  65  coinciding with the hinges  66  is flat to allow practical molding of the hinge. The flat side or flat opposed sides also allows preventing rotation of the piston rod  63  around its axis when being axially displaced by the internal thread  71  of the pawl wheel  72 . 
     The pawl wheel  72  is rotated by a shape memory alloy actuator comprising a wire  73  of a shape memory alloy such as Nitinol, one end of which is attached to a rivet  74  and the other end of which is attached to the free end of an actuator spring rod  75  by means of a crimp  76 . The wire  73  extends around a pin  73   a  for change of direction. The free end of the actuator spring rod  75  is located such that it meshes with the teeth of the pawl wheel  72  and is biased by the spring force of the rod to exert a spring force in the tangential direction (arrow R 1 ) and in the radial direction (arrow R 2 ). Two end stop pins  77  and  78  limit the tangential movement of the actuator spring rod end  75 . 
     A pawl spring rod  79  is located such that the end thereof meshes with the teeth of the pawl wheel  72  and is biased to exert a spring force in the radial direction (arrow R 3 ). This end of the pawl spring rod  79  is constrained to substantially only move in the radial direction by two stop pins  80 . 
     A battery  81  supplies power to the ends of the nitinol wire  73  for heating it so as to cause it to contract. The battery  81  is connected to the rivet  74  and the crimp  76  through a flexible printed circuit film  82  on which is incorporated the control circuits necessary for any programmed sequence of heating and cooling of the wire  73  as well as any other electronically controlled functions of the device. 
     Rotation of the pawl wheel  72  in the counter clock-wise direction of the arrow R 4  is brought about as illustrated in  FIGS. 12   a - 12   c . In  FIG. 12   a  the wire  73  is cool and expanded so that the actuator spring rod end  75  is in its rightmost position abutting end stop pin  78 . The pawl spring end  79  locks the pawl wheel  72  against clock-wise rotation. 
     In  FIG. 12   b  the nitinol wire  73  has been heated and has contracted thereby pulling the actuator rod end  75  to the left against the spring forces R 1  and R 2  until it abuts the end stop pin  77 . 
     In  FIG. 12   c  the nitinol wire  73  has been cooled and the actuator spring rod end  75  is rotating the wheel  72  counter clock-wise until abutting end stop pin  78  again while the pawl rod end is ratcheting against the spring force R 3 . Hereby, the pawl wheel has been rotated the peripheral distance of one tooth thereof. 
     As the pawl wheel rotates, the internal thread  71  of the wheel meshing with the threads  67  of the flexible piston rod elements  65  displaces the piston rod  63  into the carpule  58  for dispensing insulin through the catheter  62 . 
     The end stop pins  77  and  78  are electrically connected to the flexible print board film  82  so that monitoring of the correct function of the actuator may take place by registering electrical contact between the end stop pins  77 ,  78  and the spring rod end  75  which indicates correct functioning of the actuator. 
     The flexible piston rod  63  could also be displaced by means of another actuator, for instance such as described in connection with the embodiment of  FIGS. 1-4 . 
     Referring now to  FIG. 16 , a carpule  58  identical to the one described in connection with  FIGS. 8-11  is located adjacent an actuator generally referenced by the numeral  90  with a piston  91  of the actuator abutting the not visible piston  66  of the carpule. 
     The piston  91  is attached to the end of a steel strip  92  having an arcuate cross section taken at right angles to the longitudinal direction of the strip. This arcuate shape entails a rigidity of the strip  92  against lateral deflection such that the strip can transmit pressure forces to the piston  91  without collapsing because of lateral deflection. 
     A row of evenly spaced elongate apertures  93  are provided in the strip  92  for receiving ribs  94  of a roller  95  having a gear  96  meshing with a worm gear  97 . The worm gear is actuated by an actuator that may be similar to the shape memory alloy actuators of  FIG. 6-7  or  8 - 12 . 
     By rotating the worm gear  97  the gear  96  and roller  95  are rotated whereby the ribs  94  received in the slits  93  unwind the strip  92  from the roll and displace it into the carpule whereby the piston  91  displaces the carpule piston and dispenses the insulin from the carpule  58  that is located in the dispensing device in the same manner as the carpule  58  of  FIGS. 8-12 . 
     A medicine dispensing device or insulin pump according to the invention may function in several different manners depending on the design and programming of the various control elements of the circuit board  27 : 
     1. Stand Alone Pump with Constant Flow: 
     The pump functions as a constant flow pump and may be designed for different flow rates, for instance 20 units/24 hours, 30 units/24 hours, etc. By depressing the bolus button  3  and holding it down, the pumping program is initiated and by again pressing the button  3  down and holding it, the pumping program is terminated while a short duration pressure on the bolus button  3  activates a bolus additional dosage of insulin of a certain magnitude. 
       FIG. 17  illustrates a possible programming of this type with the line  100  indicating a constant flow corresponding to 50 units/24 hr with a flow pause indicated at  101  between 20 and 21 hours after start. Bolus extra dosages are indicated at  102  and  103 . Other flow rates are indicated with broken line graphs. 
     2. Stand Alone Pump with Varying Flow: 
     A timing device is incorporated in the printed circuit board  27  so that a standard program controls the flow dispensed by the pump during recurring  24  hour periods. The pre-programmed operating instructions may for example result in a lower dosage at night than during the day and an extra dosage at mealtimes. 
       FIG. 18  illustrates a possible programming of this type with the graph  104  indicating night-time dosage  105 , day-time dosage  106 , meal-time dosage  107 , dosage pause  108  and bolus  109 . Other dosage programs are indicated in broken lines. 
     3. Programmable Pump Type 1: 
     The pump is not provided with a predetermined program, but is provided with a programmable unit in the printed circuit board  27  and can be programmed by the user or a doctor by means of a controller  29 . The programming must be able to take place through the packing material in which the dispensing device is supplied so that the user can transport the device in a sterilised sterilized packaging on vacations or the like without having to carry the controller along. The controller is a dedicated unit that for instance via a USB plug can be connected to a PC or it can be provided with cellular telephone capability for transmission of data. The controller can thus be programmed by a doctor or a user and be used for programming of the functioning of all subsequently used disposable dispensing devices. 
     4. Programmable Pump Type 2: 
     This pump functions in the same manner as programmable pump type 1, but the controller is a personal data device such as the type marketed under the trademark PALM PILOT®, or a laptop PC. This gives the additional advantage that the user may input health information and glucose level measurement results directly into the controller or programming unit and thus communicate such information to the doctor who may use this information when deciding whether the programming function of the controller or the programming unit is to be altered for subsequently used disposable dispensing devices. 
     5. Programmable Pump with Audio Input and Output: 
     By providing the dispensing device with the microphone/loudspeaker  28  and a suitable recording/play-back chip in the printed circuit  27 , short messages may be recorded by the dispensing device, and the short messages may be emitted by the device upon suitable manipulation of the bolus push button  3  or a separate recording button (not shown) mounted on the housing  2 . 
     By means of this audio capability the user may record verbally formulated information regarding glucose levels, meal composition, exercise, etc. A timer may record the timing of each recorded message. A doctor may then use these recorded messages together with information about number and timing of bolus dosages, pumping stops and the program utilized for the dispensing of the insulin so as to evaluate the treatment and decide upon any changes in the programming and instructions to the patient which may be recorded by the doctor via a mobile telephone or the like such that messages are automatically delivered to the user at predetermined times. Such a message could for example be ‘remember to measure your glucose level’ (message program to be delivered by the dispensing device to the user each morning at 8 o&#39;clock) and so on. 
     Furthermore, standard instructions can be included in the programming circuit so that the pump may deliver verbal messages to the user instead of audio signals such as beep sounds. The message could for instance be: ‘Pump is stopped’ or ‘This is your third bolus in a row and you have taken a total of eight bolus dosages today’ or ‘The pump will be empty in two hours’ and so on. Generally speaking, the audio capability described above will render the dispensing device provided with such capability much more user-friendly, especially for users initiating a treatment or not very disciplined as regards compliance. 
     6. Closed Loop Re-Programmable Pump: 
     Either the controller or the computing unit mounted in the printed circuit  27  may be programmed to react to information regarding actual glucose blood level inputted by the user perhaps together with other information, such as data regarding the timing and constitution of the last meal, to alter the programme program of the dispensing flow or dosage to take into consideration this information such that the dispensing device to a certain extent constitutes a closed loop, fuzzy logic, semi-automatic self re-programming insulin dispensing device. 
     Referring now to  FIG. 19 , the graph illustrates a dispensing program which may be used for the pumps type 3-6 where the flow varies according to time and/or to input data. 
     The programming controller  29  may be a mobile wire-less communication device such as a cellular telephone communicating with the dispensing device by audio signals transmitted to and received from the transmitter/receiver  28 . The transmissions should be preceded and terminated by an identification code to avoid disruption of the programming of the device by extraneous audio signals. Other signal identification or protection procedures such as encryption may be utilized. The audio signals may be converted to controlling signals for altering the programming of the re-programmable computing unit mounted in the circuit board  27 . 
     Signal conversion means may be provided for converting the audio signals received by the receiver into input signals for the computing means and for converting output signals from the computing means into audio signals for being transmitted by the loudspeaker. 
     Wire-less so-called SMS signals may also be utilized for transferring information between a wire-less mobile communications unit and the dispensing device, for instance by means of IR signals or so-called Bluetooth communication technology. 
     Although the basic concept of the invention is that the entire device is disposable, a variation may be that the receiver/transmitter unit  28  with recording and play back components and corresponding battery and perhaps circuit board with computing means is reusable and may be releasably received in a holder provided on the disposable portion of the device.